[Federal Register: November 1, 2007 (Volume 72, Number 211)]
[Notices]
[Page 61927-61928]
[DOCID:fr01no07-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56696; File No. SR-NYSEArca-2007-110]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change Relating to Certain Modifications to the
Initial Listing and Trading Standards for Equity Index-Linked
Securities

October 24, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 18, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange''),
through its wholly owned subsidiary, NYSE Arca Equities, Inc. (``NYSE
Arca Equities''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Arca Equities Rule
5.2(j)(6)(B)(I) to permit the listing and trading of Equity Index-
Linked Securities \3\ where the underlying index consists, in whole or
in part, of (1) securities of closed-end management investment
companies (``Closed-End Fund Securities'') or (2) investment company
units (``ETF Securities''), which, in each case, are registered under
the Investment Company Act of 1940 (the ``1940 Act'') and listed on a
national securities exchange. In addition, the Exchange proposes to
amend NYSE Arca Equities Rule 5.2(j)(6)(B)(I) to provide for a limited
exception, subject to certain proposed conditions, to one of the
initial listing standards related to the eligibility of component
securities comprising the index underlying Equity Index-Linked
Securities. The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and http://www.nyse.com
.

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    \3\ NYSE Arca Equities Rule 5.2(j)(6) defines Equity Index-
Linked Securities as securities that provide for the payment at
maturity of a cash amount based on the performance of an underlying
index or indexes of equity securities, also referred to as the
``Equity Reference Asset.'' See NYSE Arca Equities Rule 5.2(j)(6).
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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 amend NYSE Arca Equities Rule
5.2(j)(6)(B)(I) to permit the listing and trading of Equity Index-
Linked Securities where the underlying index consists in whole or in
part of Closed-End Fund Securities or ETF Securities, which, in each
case, are registered under the 1940 Act and are listed on national
securities exchange. NYSE Arca Equities Rule 5.2(j)(6)(B)(I) currently
permits the Exchange to list and trade, pursuant to Rule 19b-4(e) under
the Act,\4\ Equity Index-Linked Securities if, among other
requirements, all component securities included in the underlying index
are either: (1) Securities (other than foreign country securities and
American Depository Receipts (``ADRs'')) that are (a) issued by a
reporting company under the Act that is listed on a national securities
exchange and (b) an ``NMS stock,'' as defined in Rule 600 of Regulation
NMS;\5\ or (2) foreign country securities or ADRs, subject to certain
limitations. The Exchange proposes to amend Rule 5.2(j)(6)(B)(I) to
include Closed-End Fund Securities and ETF Securities that are NMS
stocks listed on national securities exchanges as components, in whole
or in part, in any index underlying an issuance of Equity Index-Linked
Securities. The Exchange believes that trading in exchange-listed
Closed-End Fund Securities and ETF Securities is subject to the same
level of regulation as exchange-listed equity securities. In addition,
Closed-End Fund Securities and ETF Securities trade on the same
exchange platforms as equity securities registered under the Act and
are subject to the same exchange trading rules as equity securities. As
such, the Exchange believes that it is appropriate to permit their
inclusion as components of indexes underlying Equity Index-Linked
Securities.
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    \4\ See 17 CFR 240.19b-4(e). Rule 19b-4(e) provides that the
listing and trading of a new derivative securities product by a
self-regulatory organization (``SRO'') shall not be deemed a
proposed rule change, pursuant to paragraph (c)(1) of Rule 19b-4, if
the Commission has approved, pursuant to Section 19(b) of the Act
(15 U.S.C. 78s(b)), the SRO's trading rules, procedures, and listing
standards for the product class that would include the new
derivative securities product, and the SRO has a surveillance
program for such product class.
    \5\ See 17 CFR 242.600(b)(47).
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    The Exchange also proposes to amend NYSE Arca Equities Rule
5.2(j)(6)(B)(I)(1)(b)(v) to incorporate a limited exception to the
requirement that 90% of the index's numerical value and at least 80% of
the total number of component securities underlying an Equity Reference
Asset must meet the then current criteria for standardized options
trading set forth in NYSE Arca Rule 5.3. The Exchange proposes that an
underlying index would not be subject to such requirement if (1) no
underlying component security represents more than 10% of the dollar
weight of such index and (ii) such index has a minimum of 20 component
securities.
    All of the options exchanges apply the same criteria to securities
underlying exchange-traded options.\6\ These criteria relate primarily
to the distribution and trading volume of the securities underlying an
option\7\ and, as such, the Exchange believes that such criteria are
duplicative of the minimum market capitalization and trading volume
requirements for securities underlying Equity Index-Linked Securities
set forth in NYSE Arca Equities Rule 5.2(j)(6)(B)(I)(1)(b)(i) and (ii),
respectively. The Exchange notes that the current requirement of NYSE
Arca

Equities Rule 5.2(j)(6)(B)(I)(1)(b)(ii) that relates to minimum trading
volume for each component security is more stringent than the trading
volume requirement related to options trading.\8\ Notwithstanding the
foregoing, while a significant number of listed equity securities meet
the minimum market capitalization and trading volume requirements for
components of equity indexes under NYSE Arca Equities Rule 5.2(j)(6),
the Exchange represents that many do not meet the current criteria for
standardized options trading. The Exchange believes that the explicit
market capitalization and trading volume requirements of NYSE Arca
Equities Rule 5.2(j)(6)(B)(I)(1)(b)(i) and (ii), respectively, are
sufficient to ensure that any component security comprising an Equity
Reference Asset underlying a series of Equity Index-Linked Securities
will have an adequate liquid trading market. In addition, the Exchange
believes that, by requiring that both proposed conditions to NYSE Arca
Equities Rule 5.2(j)(6)(B)(I)(1)(b)(v) (i.e., enhancing concentration
limits for component securities and increasing the minimum number of
component securities) be met in order to avail of the proposed
exemption to such rule, the proposal would significantly reduce the
possibility of manipulation of the index. Based on the foregoing, the
Exchange believes that the protection of requiring such securities to
be qualified for options trading is unnecessary.
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    \6\ See, e.g., Rule 1009 of the Philadelphia Stock Exchange,
Inc.; Rule 5.3 of the Chicago Board Options Exchange, Incorporated;
Rule 5.3 of NYSE Arca; and Rule 502 of the International Securities
Exchange, LLC.
    \7\ The rules generally require a minimum of 7,000,000 publicly-
held shares, 2,000 holders, a trading volume of at least 2,400,000
shares in the preceding 12 months, and a market price per share of
the underlying security of at least $3.00 per share for securities
that are ``covered securities,'' as defined in Section 18(b)(1) of
the Securities Act of 1933 (15 U.S.C. 77r(b)(1)), and a market price
per share of the underlying security of at least $7.50 for
securities that are not ``covered securities.''
    \8\ NYSE Arca Equities Rule 5.2(j)(6)(B)(I)(1)(b)(ii) requires
that each component security must have trading volume in each of the
last six months or not less than 1,000,000 shares per month, except
that for each of the lowest dollar weighted component securities in
the index that, in the aggregate, account for no more than 10% of
the dollar weight of the index, the trading volume shall be at least
500,000 shares per month in each of the last six months. In
contrast, the options criteria for underlying securities generally
require a minimum trading volume (in all markets in which the
underlying security is traded) of 2,400,000 shares in the preceding
twelve months, as stated above.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\10\ in particular, in that it
is designed 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.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposed rule change will impose no
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    The Exchange states that no written comments were solicited or
received with respect to the proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which NYSE Arca consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2007-110 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSEArca-2007-110.
This file number should be included on the subject line if e-mail is
used. To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2007-110 and should
be submitted on or before November 23, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
Nancy M. Morris,
Secretary.
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    \11\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. E7-21454 Filed 10-31-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Rules and Regulations]
[Pages 27268-27271]
[FR Doc No: 2021-10605]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0143; Product Identifier 2019-SW-024-AD; Amendment
39-21547; AD 2021-10-14]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Helicopters Deutschland GmbH Model BO-105A, BO-105C, BO-
105S, and BO-105LS A-3 helicopters. This AD was prompted by the FAA's
determination that aging of the elastomeric material in a tension
torsion strap (TT-strap) could affect the structural characteristics of
the TT-strap. This AD requires replacement of certain TT-straps with
serviceable parts and implementation of a new storage life limit for
TT-straps, as specified in a European Aviation Safety Agency (now
European Union Aviation Safety Agency) (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective June 24, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 24,
2021.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information

on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0143.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0143; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Blaine Williams, Aviation Safety
Engineer, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood,
CA 90712 4137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0024, dated February 4, 2019
(EASA AD 2019-0024) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for certain Airbus Helicopters Deutschland GmbH Model BO-105A, BO-105C,
BO-105D, BO-105S, and BO-105LS A-3 helicopters. Model BO-105D
helicopters are not certificated by the FAA and are not included on the
U.S. type certificate data sheet; this AD therefore does not include
those helicopters in the applicability.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus
Helicopters Deutschland GmbH Model BO-105A, BO-105C, BO-105S, and BO-
105LS A-3 helicopters. The NPRM published in the Federal Register on
March 12, 2021 (86 FR 14023). The NPRM was prompted by the FAA's
determination that aging of the elastomeric material in a tension TT-
strap could affect the structural characteristics of the TT-strap. The
NPRM proposed to require replacement of certain TT-straps with
serviceable parts and implementation of a new storage life limit for
TT-straps, as specified in an EASA AD.
    The FAA is issuing this AD to address aging of the elastomeric
material in a TT-strap, which could lead to premature failure of a TT-
strap, resulting in loss of control of the helicopter. See the MCAI for
additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2019-0024 specifies procedures for replacing certain TT-
straps with serviceable parts and requires a storage life limit for TT-
straps. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Differences Between This AD and the MCAI

    Although EASA AD 2019-0024 does not specify a life limit for the
Lord TT-Straps part number (P/N) J17322-1 and P/N 117-14111, this AD
does specify a life limit for those parts.
    Where EASA AD 2019-0024 specifies that installation of a Lord TT-
Strap is allowed provided the first flight of that helicopter after
that installation is accomplished before the storage life of that Lord
TT-Strap exceeds 5 years, for this AD, the installation of a Lord TT-
Strap is allowed provided the first flight of that helicopter after
that installation is accomplished before 5 years since the TT-strap's
date of manufacture.
    Where EASA AD 2019-0024 defines ``serviceable part'' as a Lord TT-
Strap having a storage life not exceeding 5 years, for this AD, a
serviceable part is Lord TT-straps P/N J17322-1 and P/N 117-14111
having less than 5 years since that TT-strap's date of manufacture.
    Where EASA AD 2019-0024 specifies that the ``cure date'' of a TT-
Strap can be determined using the information provided in the
applicable service information specified in EASA AD 2019-0024, or
contacting Airbus Helicopters for applicable instructions, for this AD,
the option of contacting Airbus Helicopters is not required.

Costs of Compliance

    The FAA estimates that this AD affects 61 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
              Labor cost                      Parts cost            Cost per product      Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...  Up to $4,800...........  Up to $5,140...........  Up to $313,540.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators. The FAA does not control warranty coverage for
affected operators. As a result, the FAA has included all known costs
in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds

necessary for safety in air commerce. This regulation is within the
scope of that authority because it addresses an unsafe condition that
is likely to exist or develop on products identified in this rulemaking
action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-10-14 Airbus Helicopters Deutschland GmbH: Amendment 39-21547;
Docket No. FAA-2021-0143; Product Identifier 2019-SW-024-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective June 24, 2021.

(b) Affected ADs

    This AD affects AD 2016-25-14, Amendment 39-18740 (81 FR 94944,
December 27, 2016) (AD 2016-25-14).

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model BO-
105A, BO-105C, BO-105S, and BO-105LS A-3 helicopters, certificated
in any category, equipped with a tension torsion strap (TT-strap) as
identified in European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2019-0024, dated February 4, 2019
(EASA AD 2019-0024).

(d) Subject

    Joint Aircraft System Component (JASC) Code 6200, Main Rotor
System.

(e) Reason

    This AD was prompted by the FAA's determination that aging of
the elastomeric material in a TT-strap could affect the structural
characteristics of the TT-strap. The FAA is issuing this AD to
address aging of the elastomeric material in a TT-strap, which could
lead to premature failure of a TT-strap, resulting in loss of
control of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2019-0024.

(h) Exceptions to EASA AD 2019-0024

    (1) Where EASA AD 2019-0024 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0024 does not apply
to this AD.
    (3) Where EASA AD 2019-0024 and the service information
referenced in EASA AD 2019-0024 specify contacting Airbus
Helicopters Deutschland if the storage time for a TT-strap is equal
to or greater than 5 years, this AD requires repair using a method
approved by the Manager, International Validation Branch, FAA. For a
repair method to be approved by the Manager, International
Validation Branch, as required by this paragraph, the Manager's
approval letter must specifically refer to this AD.
    (4) Although the service information referenced in EASA AD 2019-
0024 specifies to scrap certain parts, this AD requires removing
those parts from service instead.
    (5) Where paragraph (1) of EASA AD 2019-0024 specifies to
replace each Lord TT-Strap and Bendix TT-Strap ``in accordance with
the instructions of the applicable ASB,'' the replacement must be
done using FAA-approved procedures.
    (6) Where EASA AD 2019-0024 refers to the airworthiness
limitations items of the airworthiness limitations section of the
aircraft maintenance manual (AMM) for the definition of service life
limit (SLL), this AD requires using the life limits specified in
paragraphs (h)(6)(i) through (iii) of this AD, as applicable:
    (i) For Bendix TT-Strap part number (P/N) 2604067 and P/N 117-
14110: Before 10 years or 40,000 flight cycles on the part,
whichever occurs first.
    (ii) For Bendix TT-Strap P/N 2602559 and P/N 2606576: Before 10
years, 2,400 hours time-in-service, or 40,000 flight cycles on the
part, whichever occurs first.
    (iii) For Lord TT-Strap P/N J17322-1 and P/N 117-14111: Before
12 years or 40,000 flight cycles on the part, whichever occurs
first.
    (7) Where paragraph (3) of EASA AD 2019-0024 specifies that
installation of a Lord TT-Strap is allowed provided the first flight
of that helicopter after that installation is accomplished before
the storage life of that Lord TT-Strap exceeds 5 years, for this AD,
the installation of a Lord TT-Strap is allowed provided the first
flight of that helicopter after that installation is accomplished
before 5 years since the TT-strap's date of manufacture.
    (8) Where EASA AD 2019-0024 defines ``serviceable part'' as a
Lord TT-Strap having a storage life not exceeding 5 years, for this
AD, a serviceable part is Lord TT-straps P/N J17322-1 and P/N 117-
14111 having less than 5 years since that TT-strap's date of
manufacture.
    (9) Where EASA AD 2019-0024 specifies that the ``cure date'' of
a TT-Strap can be determined using the information provided in the
applicable service information specified in EASA AD 2019-0024, or
contacting Airbus Helicopters for applicable instructions, for this
AD, the option of contacting Airbus Helicopters is not required.

(i) Repetitive Replacement

    After accomplishing the replacement specified in paragraph (1)
of EASA AD 2019-0024, thereafter, replace the Lord TT-straps P/N
J17322-1 and P/N 117-14111, at intervals not to exceed: Before 12
years or 40,000 flight cycles on the part, whichever occurs first.

(j) Terminating Action for AD 2016-25-14

    For Model B0-105LS A-3 helicopters: After accomplishing the
replacement specified in paragraph (1) of EASA AD 2019-0024 all of
the actions required by AD 2016-15-14 are terminated for that
helicopter only.

(k) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are not allowed.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (m) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    For more information about this AD, contact Blaine Williams,
Aviation Safety Engineer, Los Angeles ACO Branch, 3960 Paramount
Boulevard, Lakewood, CA 90712 4137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Aviation Safety Agency (EASA) AD 2019-0024, dated
February 4, 2019.
    (ii) [Reserved]
    (3) For EASA AD 2019-0024, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0143.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 30, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-10605 Filed 5-19-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 74991-74993]
[FR Doc No: 2023-24097]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC24-2-000]

Commission Information Collection Activities (FERC-725R); Comment
Request; Extention

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of revision of information collection and request for
comments.

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SUMMARY: In compliance with the Paperwork Reduction Act, the Federal
Energy Regulatory Commission (Commission or FERC) is soliciting public
comment on revisions of the information collection FERC-725R (Mandatory
Reliability Standards for the Bulk-Power System: BAL Reliability
Standards).

DATES: Comments on the collection of information are due January 2,
2024.

ADDRESSES: Comments should be submitted to the Commission, in Docket
No. IC24-2-000, by one of the following methods:
    Electronic filing through https://www.ferc.gov is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery:
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) Delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at http://www.ferc.gov. For user
assistance, contact FERC Online Support by email at
[email protected], or by phone at:<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725R, Mandatory Reliability Standards for the Bulk-
Power System: BAL Reliability Standards.
    OMB Control No.: 1902-0268.
    Type of Request: OMB renewal of the FERC-725R information
collection requirements, with no changes to the requirements.
    Abstract: The FERC 725R information collection includes four
reliability standards.

 BAL-001-2, Real Power Balancing Control Performance;
(effective July 1, 2016)
 BAL-002-3, Disturbance Control Standard--Contingency Reserve
for Recovery from a Balancing Contingency Event; (effective April 1,
2019)
 BAL-003-2, Frequency Response and Frequency Bias Setting;
(effective December 1, 2020)
 BAL-005-1, Balancing Authority Control. (effective January 1,
2019)

    On August 8, 2005, Congress enacted into law the Electricity
Modernization Act of 2005, which is title XII, subtitle A, of the
Energy Policy Act of 2005 (EPAct 2005).\1\ EPAct 2005 added a new
section 215 to the Federal Power Act (FPA), which required a
Commission-certified Electric Reliability Organization (ERO) to develop
mandatory and enforceable Reliability Standards, which are subject to
Commission review and approval. Once approved, any Reliability Standard
may be enforced by the ERO subject to Commission oversight, or the
Commission may independently enforce Reliability Standards.\2\
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    \1\ Energy Policy Act of 2005, Public Law 109-58, title XII,
subtitle A, 119 Stat. 594, 941 (codified at 16 U.S.C. 824o).
    \2\ 16 U.S.C. 824o(e)(3).
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    On February 3, 2006, the Commission issued Order No. 672,
implementing section 215 of the FPA.\3\ Pursuant to

Order No. 672, the Commission certified one organization, North
American Electric Reliability Corporation (NERC), as the ERO.\4\ The
Reliability Standards developed by the ERO and approved by the
Commission apply to users, owners and operators of the Bulk-Power
System as set forth in each Reliability Standard.
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    \3\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, order on reh'g, Order No. 672-A, FERC
Stats. & Regs. ] 31,212 (2006).
    \4\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g and compliance, 117 FERC ] 61,126 (2006),
order on compliance, 118 FERC ] 61,190, order on reh'g, 119 FERC ]
61,046 (2007), aff'd sub nom. Alcoa Inc. v. FERC, 564 F.3d 1342
(D.C. Cir. 2009).
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    This collection was last revised beginning on December 19, 2019
when NERC submitted for approval the proposed Reliability Standard BAL-
003-2.
    Types of Respondents: Balancing authorities and a Frequency
Response Sharing Group (FRSG).
    Estimate of Annual Burden: 5 The estimated burdens of
the FERC 725R includes the Reliability Standards: BAL-001-2, BAL-002-3,
BAL-003-2, and BAL-005-1.
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    \5\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a federal agency. See 5
CFR 1320 for additional information on the definition of information
collection burden.
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    The requirements for each Reliability Standard go as follows:
    BAL-001-2: Real Power Balancing Control Performance. Reliability
Standard BAL-001-2 is designed to ensure that applicable entities
balance generation and load by maintaining system frequency within
narrow bounds around a scheduled value, and it improves reliability by
adding a frequency component to the measurement of a Balancing
Authority's Area Control Error (ACE).\6\
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    \6\ Area Control Error is the ``instantaneous difference between
a Balancing Authority's net actual and scheduled interchange, taking
into accounts the effects of Frequency Bias, correction for meter
error, and Automatic Time Error Correction (ATEC), if operating in
the ATEC mode. ATEC is only applicable to Balancing Authorities in
the Western Interconnection.'' NERC Glossary.
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    BAL-002-3: Disturbance Control Standard--Contingency Reserve for
Recovery from a Balancing Contingency Event. This standard ensures that
a responsible entity, either a balancing authority or reserve sharing
group, is able to recover from system contingencies by deploying
adequate reserves to return their Area Control Error to defined values
and replacing the capacity and energy lost due to generation or
transmission equipment outages.
    BAL-003-2: Frequency Response and Frequency Bias Setting. This
standard requires sufficient Frequency Response from the Balancing
Authority (BA) to maintain Interconnection Frequency within predefined
bounds by arresting frequency deviations and supporting frequency until
the frequency is restored.
    BAL-005-1: Balancing Authority Control. This standard establishes
requirements for acquiring data necessary to calculate Reporting Area
Control Error (Reporting ACE). The standard also specifies a minimum
periodicity, accuracy, and availability requirement for acquisition of
the data and for providing the information to the System Operator. It
requires balancing authorities to maintain minimum levels of annual
availability of 99.5% for each balancing authority system for
calculating Reporting ACE.
    Our estimates are based on the NERC Compliance Registry as of
September 22, 2023, which indicates that there are for unique US only
98 registered balancing authorities, 8 registered reserve sharing group
(RSG) and 1 frequency response sharing group (FRSG).\7\
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    \7\ NERC Compliance Registry (September 22, 2023), available at
https://www.nerc.com/pa/comp/Registration%20and%20Certification%20DL/NERC_Compliance_Registry_Matrix_Excel.xlsx.
---------------------------------------------------------------------------

    Estimates for the average annual burden and cost \8\ follow.
---------------------------------------------------------------------------

    \8\ The hourly cost estimates are based on wage data from the
Bureau of Labor Statistics for May 2022 (at https://www.bls.gov/oes/current/naics2_22.htm) and benefits data for Dec. 2022 (issued March
2023, at https://www.bls.gov/news.release/ecec.nr0.htm). The hourly
costs (for wages and benefits) for reporting are: Electrical
Engineer (Occupation code 17-2071), $77.29. The hourly costs (for
wages and benefits) for evidence retention are: Information and
Record Clerk (Occupation code 43-4199), $56.14.

                                                                        FERC-725R
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of annual   Total number
              Function                Number & type    responses per       of annual    Average burden hours & cost ($)    Total annual burden hours &
                                     of respondents      respondent        responses              per response                total annual cost ($)
                                                (1)                (2)     (1) x (2) =  (4)............................  (3) x (4) = (5)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        BAL-001-2
--------------------------------------------------------------------------------------------------------------------------------------------------------
BA Reporting Requirements..........              98                  1              98  8 hrs.; $618.32................  784 hrs.; $60,595.36.
BA Recordkeeping Requirements......              98                  1              98  4 hrs.; $224.56................  392 hrs.; $22,006.88.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        BAL-002-3
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BA & RSG Reporting Requirements....             106                  1             106  8 hrs.; $618.32................  848 hrs.; $65,541.92.
BA & RSG Recordkeeping Requirements             106                  1             106  4 hrs.; $224.56................  424 hrs.; $23,803.36.
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                                                                        BAL-003-2
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BA & FRSG Reporting Requirements...              99                 28           2,772  8 hrs.; $618.32................  22,176 hrs.; $1,713,983.04.
BA & FRSG Recordkeeping                          99                  1              99  2 hrs.; $112.28................  198 hrs.; $11,115.72.
 Requirements.
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                                                                        BAL-005-1
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BA Reporting Requirements..........              98                  1              98  1 hr.; $77.29..................  98 hrs.; $7,574.42.

BA Recordkeeping Requirements......              98                  1              98  1 hr.; $56.14..................  98 hrs.; $5,501.72.
                                    --------------------------------------------------------------------------------------------------------------------
    SUB-TOTAL FOR REPORTING          ..............  .................  ..............  ...............................  23,906 hrs.; $1,847,694.74.
     REQUIREMENTS.
                                    --------------------------------------------------------------------------------------------------------------------
    SUB-TOTAL FOR RECORDKEEPING      ..............  .................  ..............  ...............................  1,112 hrs.; $62,427.68.
     REQUIREMENTS.
                                    --------------------------------------------------------------------------------------------------------------------
        TOTAL FOR FERC-725R          ..............  .................  ..............  ...............................  25,018 hrs.; $1,910,122.42.
         (rounded).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: October 26, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-24097 Filed 10-31-23; 8:45 am]
BILLING CODE 6717-01-P


PINE OIL TOXICOLOGY CHAPTER September 8, 2004 TABLE OF CONTENTS 1.0 HAZARD CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.0 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.0 DATA GAPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.0 HAZARD ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.1 Acute Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.2 Subchronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.3 Prenatal Developmental Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4.4 Reproductive Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 4.5 Mutagenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 4.6 Neurotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 4.7 Metabolism. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5.0 TOXICITY ENDPOINT SELECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5.1 See Section 9.2 for Endpoint Selection Table. . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5.2 Dermal Absorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5.3 Classification of Carcinogenic Potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6.0 FQPA CONSIDERATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6.1 Special Sensitivity to Infants and Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6.2 Recommendation for a Developmental Neurotoxicity Study . . . . . . . . . . . . . . . 11 7.0 ENDOCRINE DISRUPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 8.0 OTHER ISSUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 9.0 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 10.0 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.1 Toxicity Profile Summary Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.1.1 Acute Toxicity Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.1.2 Subchronic, Chronic and Other Toxicity Tables . . . . . . . . . . . . . . . . . . . 14 10.2 Summary of Toxicological Dose and Endpoints . . . . . . . . . . . . . . . . . . . . . . . . 16 Page 3 of 17 1.0 HAZARD CHARACTERIZATION Pine Oil is a complex combination of terpenes produced by high temperature distillation of oil of turpentine or by catalytic hydration of terpenes. Pine oil contains a minimum of 60% isomeric secondary and tertiary cyclic terpene alcohols and a maximum of 40% non terpene alcohol components consisting of terpene hydrocarbons, terpene ether, and ketones. This complex blend forms a sole active ingrediet containing no impurities. The CSPA Pine Oil joint venture has submitted toxicology data to the Office of Pesticide Programs on different ` blends' of pine oil, namely, Pine Oil Blend 1687, Pine Oil Blend 110990, and Pine Oil Blend 012494.

Pine Oil is registered for use as a disinfectant, sanitizer, microbiocide/ microbiostat, virucide, and insecticide for indoor food use, indoor non food use, indoor residential use, indoor medical use, and aquatic non food industrial use. There are at least 23 registered labels containing pine oil or pine oil mixed with a quaternary ammonium compound. Some of these formulations are allowed for use as hard surface disinfectants in eating establishments where there may be the potential for indirect transfer to food.

The acute toxicity of Pine Oil is relatively low. Acute toxicity studies submitted to the Office of Pesticide Programs show low toxicity by the oral route ( Toxicity Category III, oral LD 50 = 2.7 g/ kg ), dermal route ( Toxicity category III, dermal LD50 > 2000 mg/ kg), and inhalation route ( LC50 > 3.67 mg/ L, Toxicity category IV). Pine oil is a moderate skin irritant ( category III) but shows a stronger response as an eye irritant ( category II).

Non acute toxicity testing with Pine oil is limited to one 14 day dermal toxicity test, one 90 day dermal toxicity test, and one developmental toxicity test in the rat. In the 14 day dermal toxicity test ( submitted under MRID 40515401), no significant adverse effects were observed up to a dose of 940 mg/ kg. In the 90 day test, the highest dose that could be tested without significant dermal irritation was 226 mg/ kg/ day, and no significant systemic or dermal effects were observed up to and including this dose level.

Developmental toxicity testing of pine oil in the rat ( submitted under MRID 40515201) showed maternal toxicity in the form of excess salivation, alopecia, and ungroomed coat at doses of 600 and 1200 mg/ kg/ day as well as increased adrenal weight at 1200 mg/ kg/ day. Maternal animals who died at the 1200 mg/ kg/ day dose level exhibited ataxia, decreased motor activity, and impaired righting reflex prior to death, raising the possibility of a neurotoxic effect. External examination of fetuses showed an increased fetal and litter incidence of depressed eye bulge at the 1200 mg/ kg/ day dose. Visceral examination showed dilation of the lateral ventricles at 1200 mg/ kg/ day, and increased incidence of micropthalmia. Skeletal examination showed increased fetal and litter incidence of non ossified or incompletely ossified skull, vertebrae, manubrium, sternebrae, and pelvis. The maternal and developmental toxicity NOAEL were determined to be 50 mg/ kg/ day in this study and were considered somewhat conservative based on the lack of any other studies available for non acute toxicity of pine oil. Page 4 of 17 Mutagenicity testing of Pine oil in various assays ( Ames Salmonella assay, micronucleus assay, and mammalian cells in culture assay) showed the chemical blend to be negative, but the cell culture assay was considered unacceptable and must be repeated.

On February 24, 2004 , the Antimicrobials Division's Toxicology Endpoint Selection Committee ( ADTC) reviewed the available Toxicology data for Pine Oil and discussed endpoint selection for use as appropriate in occupational/ residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to pine oil was also evaluated by the committee in order to meet the statutory requirements of the Food Quality Protection Act ( FQPA) of 1996. Page 5 of 17 2.0 TOXICOLOGY DATA REQUIREMENTS The requirements ( CFR 158.340) for the registered uses for Pine Oil are in Table 1. Use of the new guideline numbers does not imply that the new ( 1998) guideline protocols were used.

Table 1. Toxicity Data Requirements for Pine Oil Test Technical Required Satisfied 870.1100Acute Oral Toxicity . . . . . . . . . . . . . . . . . . . 870.1200Acute Dermal Toxicity . . . . . . . . . . . . . . . . . 870.1300Acute Inhalation Toxicity . . . . . . . . . . . . . . . 870.2400 Primary Eye Irritation . . . . . . . . . . . . . . . . . . 870.2500 Primary Dermal Irritation . . . . . . . . . . . . . . . 870.2600 Dermal Sensitization . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes yes no 870.3100 Oral Subchronic ( rodent) . . . . . . . . . . . . . . . 870.3150 Oral Subchronic ( nonrodent) . . . . . . . . . . . . 870.3250 90 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . 870.3465 90 Day Inhalation . . . . . . . . . . . . . . . . . . . . . yes no yes no no yes1 870.3700 Developmental Toxicity ( rodent) . . . . . . . . . 870.3700 Developmental Toxicity ( nonrodent) . . . . . . . 870.3800Reproduction . . . . . . . . . . . . . . . . . . . . . . . . yes no yes yes no 870.4100Chronic Toxicity ( rodent) . . . . . . . . . . . . . . . 870.4100Chronic Toxicity ( nonrodent) . . . . . . . . . . . . 870.4200 Oncogenicity ( rat) . . . . . . . . . . . . . . . . . . . . 870.4200 Oncogenicity ( mouse) . . . . . . . . . . . . . . . . . . no no no no 870.5100Mutagenicity C Gene Mutation  bacterial . . . 870.5375Mutagenicity C CHO Assay . . . . . . . . . . . . . 870.5550Mutagenicity C Other Genotoxic Effects . . . . yes yes yes yes no yes 870.6100 Acute Delayed Neurotox. ( hen) . . . . . . . . . . 870.6300 Developmental Neurotoxicity . . . . . . . . . . . . no no

870.7485 General Metabolism . . . . . . . . . . . . . . . . . . . no 1although the 90 day study is classified as unacceptable/ guideline, the data from the 90 day dermal toxicity study in conjunction with the 14 day dermal toxicity study ( contained within the 90 day study) provide enough data for regulatory purposes. Page 6 of 17 3.0 DATA GAPS Data gaps exist for a two generation reproduction toxicity test and a 90 day oral toxicity test with neurotoxic endpoint evaluation. These aspects of Pine Oil are not adequately addressed by the current toxicology database, and uncertainty factors have been used in the absence of these data.

In addition, data gaps exist for the dermal sensitization assay and the in vitro mammalian cells in culture assay. These studies must be repeated. The sensitization assay used an inadequate number of animals to make a determination of sensitization, and the CHO assay had significant problems with the integrity of the cell cultures that compromised the results of the study.

4.0 HAZARD ASSESSMENT 4.1 Acute Toxicity Adequacy of data base for acute toxicity: The data base for acute toxicity is considered incomplete. The dermal sensitization assay must be repeated.

The acute toxicity data on technical Pine Oil is summarized below in Table 2.

Table 2. Acute Toxicity Profile for Pine Oil Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100 Acute oral toxicity Rat 40253502 LD50( combined) = 2.7 g/ kg III 870.1200 Acute Dermal toxicity Rat 40253503 LD50 > 2000 mg/ kg III 870.1300 Acute inhalation toxicity Rat 43375208 LC50 > 3.67 mg/ L IV 870.2500 Dermal irritation Rabbit 43375210 erythema/ edema up to 7 days post dose III 870.2400 Primary Eye Irritation 43375209 irritation lasting up to 16 days II 870.2600 Skin sensitization Guinea pig not a sensitizer study unacceptable Page 7 of 17 4.2 Subchronic Toxicity Adequacy of data base for subchronic toxicity: The data base for subchronic toxicity of pine oil is incomplete. A subchronic oral toxicity with neurotoxicity evaluation is considered necessary for adequate evaluation of the hazard from repeated oral exposure. Only a 90 day dermal toxicity study exists which had deficiencies.

870.3250 90 Day Dermal Toxicity B Rat Executive Summary: In a 90 day dermal toxicity study ( MRID 40515401), Pine Oil Blend CSMA 1687 (% a. i. and batch/ lot number not reported) was applied to the shaved skin of 10 Crl: CD ® BR rats/ sex/ dose at dose levels of 0, 50, 113, and 226 mg/ kg bw/ day, 6 hours/ day for 5 days/ week during a 90 day period. The application method involved applying the test article dosage to one quadrant of the shaved area on the back of each rat ( reportedly 25% of the surface area was shaved) with each quadrant being exposed once every four days throughout the study period.

There were no compound related effects on mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, organ weights, or gross pathology. No significant adverse dermal reactions were observed due to treatment; very slight to slight erythema was observed in the female treated rats, desquamation and scabbing occurred sporadically in male and female treated rats, and microscopic changes included minimal to mild acanthosis and minimal hyperkeratosis with similar incidences in both the controls and 226 mg/ kg/ day rats. The skin in the low dose animals did exhibit slight injury with evidence of desquamation, scabbing, and very slight to slight erythema, however. Again, these dermal irritation responses were sporadic and of a minimal severity but if the skin had been treated in accordance with guidelines with the entire shaved application area being treated at least 5 days/ week for 6 hours then more substantial injury to the dermis might have occurred.

A slight increase was observed in the incidence of tingable bodies in macrophages in the thymus of treated rats. There was no dose response in incidence or severity of this finding. Therefore, the systemic toxicity no observable adverse effect level ( NOAEL) is

226 mg/ kg/ day due to a lack of a treatment related response in any of the dose groups. A lowest observable adverse effect level ( LOAEL) could not be determined due to a lack of treatment related effects.

A dermal toxicity LOAEL could not be determined; the dermal NOAEL is

226 mg/ kg/ day based on the lack of consistent dose related effects on the skin. It is noted, however, that in the 14 day range finding study, a dermal NOAEL of 940 mg/ kg/ day could be identified. An accurate determination of a dermal NOAEL is complicated by the dosing methodology used in both the 14 day and 90 day studies, in which the same area of shaved skin was not dosed each day. Page 8 of 17 This 90 day dermal toxicity study in the rat is unacceptable guideline. Although the study does not satisfy the guideline requirement for a 90 day dermal toxicity study ( OPPTS 870.3250; OECD 411) in the rat, the data from the 14 day study provides enough additional information in conjunction with the 90 day study to determine a NOAEL value for regulatory purposes.

870.3465 90 Day Inhalation B Rat A 90 day inhalation toxicity study is not available for Pine Oil. An oral endpoint was selected for use in risk assessment if necessary.

4.3 Prenatal Developmental Toxicity Adequacy of data base for Prenatal Developmental Toxicity: The data base for prenatal developmental toxicity is considered complete. No additional studies are required at this time.

870.3700 Prenatal Developmental Toxicity Study  Rat Executive Summary: Pine Oil blend 1687 was administered to 25 mated female Sprague Dawley rats by gavage at doses of 0, 50, 600, or 1200 mg/ kg/ day from days 6 15 of gestation. Abnormal clinical signs consisting of excess salivation, alopecia, and ungroomed coat were observed in increased incidence at the 600 and 1200 mg/ kg/ day dose level in maternal animals. Body weight gain at the 1200 mg/ kg/ day dose level was decreased 60% during the dosing period, and 37% when corrected for gravid uterine weight. Overall corrected weight gain was decreased 17% for days 0 20 of the study. Food consumption by contrast was decreased 27% during the treatment phase and 5% overall ( days 0 20). Therefore it is possible that the effect on body weight was treatment related at the 1200 mg/ kg/ day dose level. Adrenal gland weight was significantly increased in maternal animals at the 1200 mg/ kg/ day dose level. Maternal deaths were increased at the 1200 mg/ kg/ day dose level, where 6 animals died after three to seven doses had been administered. These animals demonstrated ataxia, decreased motor activity, and impaired righting reflex prior to death. Mean fetal weight was significantly decreased at the 1200 mg/ kg/ day dose level vs. control, but there were no other abnormal cesarean section observations.

External examination of fetuses showed an increased fetal and litter incidence of depressed eye bulge at the 1200 mg/ kg/ day dose. Visceral examination showed dilation of the lateral ventricles at 1200 mg/ kg/ day, and increased incidence of micropthalmia. Skeletal examination showed increased fetal and litter incidence of non ossified or incompletely ossified skull, vertebrae, manubrium, sternebrae, and pelvis. Page 9 of 17 The dose spacing in this study ( i. e. 50, 600, 1200 mg/ kg/ day) along with the appearance of effects mainly at 1200 but also at 600 mg/ kg/ day suggests that effects could have arisen at doses lower than 1200 mg/ kg/ day but greater than 600 mg/ kg/ day. This, in conjunction with the fact that there is only one developmental toxicity study for Pine Oil submitted to the Agency, leads to a conservative effect level ( LOAEL) of 600 mg/ kg/ day with a NOAEL of 50 mg/ kg/ day for both maternal and developmental toxicity.

4.4 Reproductive Toxicity Adequacy of data base for Reproductive Toxicity: The data base for reproductive toxicity is considered incomplete. Reproductive toxicity is not represented in any of the available toxcity data for Pine oil. As there are indirect food uses for this chemical, and in accordance with the interim working policy of AD regarding indirect food use data requirements, a reproductive toxicity study must be submitted in order to properly characterize these risks.

4.5 Mutagenicity Gene Mutation 870.5100, Ames Salomella Assay Accession # ( MRID 43375212) This study is classified as acceptableguideline In an Ames Salmonella assay, Pine oil blend 012494 was used in strains TA98, TA100, TA1535, TA1537 at concentrations of 0.1, 1.0, 100, 1000, and 10000 ug/ plate. No evidence of an increase in induced mutant colonies over background in the absence or presence of metabolic activation.

Cytogenetics 870.5375, In vitro mammalian cells in culture This study is unacceptable In an in vitro cytogenetics assay using Chinese hamster ovary ( CHO) cells, CHO cells were exposed to Pine Oil blend 1687 at 100, 130, 170, 200, 250 nl/ ml ( no metabolic activation) or 50, 100, 200, 300, 400 nl/ ml ( S9 activation). No evidence of induction of mutant colonies over background. Study not acceptable and must be repeated. Cells not checked for mycoplasma contamination, and several cultures were lost to contamination during conduct of the assay.

Other Genotoxicity 870.5550, Micronucleus assay MRID 40341403 This study is acceptable Single i. p injection with Pine Oil blend 1687 at doses of 0, 116, 578, 1155 mg/ kg. Compound toxic at the 1155 mg/ kg dose. No significant increase in frequency of micronucleated polychromatic erythrocytes in bone marrow at any test concentration or harvest time. Page 10 of 17 4.6 Neurotoxicity Adequacy of data base for Neurotoxicity: The neurotoxicity of pine oil can be addressed through the conduct of neurotoxicity screening as specified in the 90 day oral toxicity guideline.

870.6100 Delayed Neurotoxicity Study  Hen Study not required.

870.6300 Developmental Neurotoxicity Study Study not required 4.7 Metabolism Study is not required. Page 11 of 17 5.0 TOXICITY ENDPOINT SELECTION 5.1 See Section 9.2 for Endpoint Selection Table.

5.2 Dermal Absorption Dermal absorption data are not needed for pine oil. Route specific data are available from the 14 day and 90 day dermal toxicity studies from which an endpoint was selected for this route of exposure.

5.3 Classification of Carcinogenic Potential Pine oil has not been classified as to carcingenicity; however, these data are not required at this time.

6.0 FQPA CONSIDERATIONS 6.1 Special Sensitivity to Infants and Children The Antimicrobials Division Toxicology Endpoint Selection Committee ( ADTC) concluded that there is no evidence for susceptibility to exposure to pine oil from the limited data available. The ADTC also concluded that the hazard based special FQPA safety factor can be removed ( 1X) when assessing dietary risks resulting from the uses of pine oil, based on the use of conservative NOAEL values from the developmental toxicity study. However, a database uncertainty factor of 10x applies to pine oil, based on the lack of specific neurotoxicity endpoints and a reproductive toxicity study.

6.2 Recommendation for a Developmental Neurotoxicity Study A developmental neurotoxicity study is not required pine oil.

7.0 Endocrine Disruption The Agency is required under the Federal Food, Drug and Cosmetic Act ( FFDCA), as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops Page 12 of 17 and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP).

8.0 OTHER ISSUES In the review of the available toxicology database for pine oil, the ADTC included a 10x factor for the lack of data on reproductive toxicity ( required data for indirect food uses) and neurotoxicity ( from observations of neurotoxicity in the available data). Since the production of this risk assessment, the registrant has made the Agency aware of data submitted to EPA under the high production volume program that in their view addresses reproductive concerns of pine oil. These data have not been formally reviewed by the Office of Pesticide Programs for compliance with the reproductive or neurotoxicity guidelines, and only summary data were available on the Agency's High Production Volume Challenge Program. With regard to the neurotoxicity concern, the registrant stated that there was a 90 day oral toxicity study conducted for the Food and Drug Administration in 1967 that in their view supports the lack of neurotoxicity of pine oil. As with the reproductive toxicity data, the original report is not currently available to the EPA, and only a summary was provided.

If such studies provide relevant and useful information to the Agency, the data could be considered in refining any concerns with respect to reproductive toxicity or neurotoxicity. However, at the present time, there is not enough information from these studies provided to reach a different conclusion than previously stated. Page 13 of 17 9.0 REFERENCES in MRID order MRID # REFERENCES 40515201 Dearlove G. ( 1988) " Developmental Toxicity ( embryo/ fetal toxicity potential) Study of Pine Oil Blend 1687 administered orally via gavage to Crl: CD Presumed Pregnant Rats." Argus Research Laboratories, Inc.

43375212 Ferrante S. ( 1994) " Pine Oil: Salmonella typhimurium Reverse Mutation Assay." Toxikon Corporation.

40515401 Lavelgia J, Nass D. ( 1988). " 90 Day Dermal Toxicity Study in Rats with Pine Oil Blend CSMA 1687." WIL Research Laboratories, Inc.

40253503 Naas D. ( 1987) " Acute Dermal Toxicity ( LD50) study in Albino Rabbits with Pine Oil Blend CSMA 1687." WIL Research Laboratories, Inc.

40253502 Naas D. ( 1987) " Acute Oral Toxicity ( LD50) study in Albino Rats with Pine Oil Blend CSMA 1687." WIL Research Laboratories, Inc.

40341403 Putman D. ( 1987) " Micronucleus Cytogenetic Assay in Mice, Final Report." Microbiological Associates, Inc.

43375208 Robbins G. ( 1994). " Pine Oil: Acute Inhalation Toxicity Study in Rats." Cosmopolitan Safety Evaluation, Inc.

43375211 Robbins G. ( 1994). " Pine Oil: Dermal Sensitization ( Buehler) in Guinea Pigs." Cosmopolitan Safety Evaluation, Inc.

43375210 Robbins G. ( 1994). " Pine Oil: Primary Dermal Irritation Study in Rabbits." Cosmopolitan Safety Evaluation, Inc.

43375209 Robbins G. ( 1994). " Pine Oil: Primary Eye Irritation Study in Rabbits." Cosmopolitan Safety Evaluation, Inc.

40341403 Yang L. ( 1987) " CHO/ HGPRT Mutation Assay." Microbiological Associated, Inc. Page 14 of 17 10.0 APPENDICES Tables for Use in Risk Assessment 10.1 Toxicity Profile Summary Tables 10.1.1 Acute Toxicity Table  See Section 4.1 10.1.2 Subchronic, Chronic and Other Toxicity Tables Guideline No./ Study Type MRID No. ( year)/ Classification/ Doses Results 870.3250 90 day Dermal Toxicity in Rats 40515401 ( 1988) unacceptable Doses: 0, 50, 113, 226 mg/ kg/ day to shaved skin, 6 hrs/ day, 5days/ wk, 13 weeks Systemic Toxicity NOAEL = > 226 mg/ kg/ day Systemic Toxicity LOAEL = > 226 mg/ kg/ day NOAEL can be estimated from a 14 day rangefinding study that showed a dermal NOAEL of 940 mg/ kg/ day.

870.3700 Developmental Toxicity in Rats 40515201 acceptable/ guideline Doses: 0, 50, 600, 1200 mg/ kg/ day Maternal/ Developmental Toxicity NOAEL = 50 mg/ kg/ day Maternal/ Developmental Toxicity LOAEL = 600 mg/ kg/ day The dose spacing in this study ( i. e. 50, 600, 1200 mg/ kg/ day) along with the appearance of effects mainly at 1200 but also at 600 mg/ kg/ day suggests that effects could have arisen at doses lower than 1200 mg/ kg/ day but greater than 600 mg/ kg/ day. This leads to a conservative assumption of 50 mg/ kg/ day as the NOAEL for maternal and developmental toxicity.

Mutagenicity Gene Mutation 870.5100 Ames Salomella Assay 43375212 ( 1994) acceptable concentrations of 0.1, 1.0, 10, 100, 1000, 10000

g/ plate No evidence of an increase in induced mutant colonies over background in the absence or presence of metabolic activation. Page 15 of 17 Guideline No./ Study Type MRID No. ( year)/ Classification/ Doses Results In vitro Cytogenetics 870.5300 40341403 unacceptable 100, 130, 170, 200, 250 ng/ mL ( S9); 50, 100, 200, 300, 400 nL/ mL (+ S9) No evidence of induction of mutant colonies over background. Study not acceptable and must be repeated. Cells not checked for mycoplasma contamination, and several cultures were lost to contamination during conduct of the assay.

870.5395 Micronucleus Assay 40341403 acceptable i. p. doses of 0, 116, 578, 1155 mg/ kg No significant increase in frequency of micronucleated polychromatic erythrocytes in bone marrow at any test concentration or harvest time.

Neurotoxicity 870.6300 Developmental neurotoxicity Not required Page 16 of 17 10.2 Summary of Toxicological Dose and Endpoints for Pine Oil for Use in Human Risk Assessment1 Exposure Scenario Dose ( mg/ kg/ day) used in risk assessment UF / MOE Uncertainty Factors Study and Toxicological Effects Dietary Risk Assessments Acute Dietary ( gen pop) NOAEL of 50 mg/ kg/ day Acute RfD = 0.05 mg/ kg/ day UF = 1000 Developmental toxicity study in rats . Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Acute Dietary ( females 13+) NOAEL of 50 mg/ kg/ day Acute RfD = 0.05 mg/ kg/ day UF = 1000 Developmental toxicity study in rats Developmental toxicity LOAEL of 600 mg/ kg/ day based on decreased fetal weight, fetal malformations, retardation of ossification.

Chronic Dietary NOAEL= 50 Chronic RfD = 0.016 mg/ kg/ day UF = 3000 Developmental toxicity study in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Incidental Oral Short Term ( 1  30 Days) NOAEL= 50 mg/ kg/ day UF= 1000 Developmental toxicity study in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Incidental Oral Intermediate Term ( 1  6 Months) NOAEL= 50 mg/ kg/ day UF = 3000 Developmental toxicity study in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Non Dietary Risk Assessments Dermal Short  term Endpoint not required Page 17 of 17 Exposure Scenario Dose ( mg/ kg/ day) used in risk assessment UF / MOE Uncertainty Factors Study and Toxicological Effects Dermal intermediate and long term NOAEL > 226 mg/ kg/ day UF = 100 90 day dermal toxicity study in rats Dermal NOAEL of > 226 mg/ kg/ day ( highest dose tested)

Inhalation All durations LOAEL = 50 mg/ kg/ day mg/ L UF = 1000 ( ST, IT)

UF = 3000 ( LT) Developmental toxicity in rats Maternal LOAEL of 600 mg/ kg/ day based on clinical observations of toxicity, decreased body weight, weight gain, food consumption Cancer no data 1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30455-30457]
[FR Doc No: 2015-12934]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1158; FRL-9928-36-OAR]

Proposed Information Collection Request; Comment Request; RFS2
Voluntary RIN Quality Assurance Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``RFS2 Voluntary RIN Quality
Assurance Program'' (EPA ICR No.2473.03, OMB Control No. 2060-0688 to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Before doing so, EPA is soliciting public comments on specific aspects
of the proposed information collection as described below. This is a
proposed extension of the ICR, which is currently approved through
December 31, 2017. An Agency may not conduct or sponsor and a person is
not required to respond to a collection of information unless it
displays a currently valid OMB control number.

DATES: Comments must be submitted on or before July 27, 2015.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2005-0161, online using www.regulations.gov (our preferred method), or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Mary Manners, USEPA National Vehicle
and Fuel Emissions Laboratory/OAR, 2565 Plymouth Road, Rm #N07, Ann
Arbor, MI 48105; telephone number:<PHONE_NUMBER>; fax number: 734-214-
4873; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g. permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: The Renewable Fuel Standard (RFS) program began in 2006
pursuant to the requirements in Clean Air Act (CAA) section 211(o)
which were added through the Energy Policy Act of 2005 (EPAct). The
statutory requirements for the RFS program were subsequently modified
through the Energy Independence and Security Act of 2007 (EISA),
resulting in the promulgation of major revisions to the regulatory
requirements on March 26, 2010.
    The RFS program requires that specified volumes of renewable fuel
be used as transportation fuel, heating oil, and/or jet fuel each year.
To accomplish this, the Environmental Protection Agency (EPA) publishes
applicable percentage standards annually that apply to the sum of all
gasoline and diesel produced or imported. The percentage standards are
set so that if every obligated party meets the percentages, then the
amount of renewable fuel, cellulosic biofuel, biomass-based diesel, and
advanced biofuel used will meet the volumes required on a nationwide
basis.
    Obligated parties demonstrate compliance with the standards through
the acquisition of unique Renewable Identification Numbers (RINs)
assigned by the producer or importer to every batch of renewable fuel
produced or imported. Validly generated RINs show that a certain volume
of qualifying renewable fuel was produced or imported. The RFS program
also includes provisions stipulating the conditions under which RINs
are invalid, the liability carried by a party that transfers or uses an
invalid RIN, and how invalid RINs must be treated.
    The RIN system within the RFS program contains unique features that
make it somewhat challenging for the obligated parties that need RINs
for compliance purposes to verify that those RINs have been validly
generated. Several cases of fraudulently generated RINs have compelled
some obligated parties to limit their business relationships to only
those parties that appear most trustworthy. This reaction by the
obligated parties made it more difficult for smaller renewable fuel
producers to sell their RINs and reduced the overall liquidity of the
RIN market. To ensure that RINs are validly generated, individual
obligated parties are now conducting their own audits of renewable fuel
production facilities, potentially duplicating one another's efforts.
These circumstances have created inefficiencies in the RIN market,
prompting requests for an additional regulatory mechanism that would
reduce the risk of potentially invalid RINs, return liquidity to the
RIN market, and reduce the cost of verifying the validity of RINs.
    Form Numbers: 8.

RFS 1400--RFS Renewable Fuel Producers Reporting Fuels--5900-354.
RFS 1500--RFS Renewable Fuel producers Reporting Fuels (Finished Fuel
Blending)--5900-355.
RFS 1600--RFS Renewable Fuel producers Reporting Fuels (Blending
Contact)--5900-356.
RFS 2000--RFS Independent Third Party Batch Verification--5900-357.
RFS 2100--RFS Independent Third Party Batch Verification Aggregate RIN
Verification--5900-358.
RFS 2200--RFS Independent Third Party On-Site Audit Report--5900-359.
RFS 2300--RFS Independent Third Party List of Potentially Invalid
RINs--5900-360.
RFS 2400--Independent Third Party Mass Balance--5900-361.

    Respondents/affected entities: Renewable Producers, obligated
parties.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 1313 (total).
    Frequency of response: On occasion.
    Total estimated burden: 263,744 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $22,386,702 (per year), includes no
annualized capital or operation & maintenance costs.
    Changes in Estimates: This regulation will allow EPA to monitor
compliance with the RFS program. The quality assurance program would
help to ensure that the RIN system operates as originally intended. The
primary impacts of the quality assurance program would be improved
liquidity in the RIN market and improved opportunities for smaller
renewable fuel producers to sell their RINs. The data generated by the
QAP program will assist obligated parties and smaller renewable fuel
producers comply with the requirements of the RFS program by supporting
the validity of RINs. This regulation will allow regulated parties to
voluntary submit Quality Assurance Plans (QAPs) to EPA to demonstrate
the validity of the RINs they generate. This is a new collection with
no industry cost for comparison.

    Dated: May 20, 2015.
Byron Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2015-12934 Filed 5-27-15; 8:45 am]
 BILLING CODE 6560-50-P