[Federal Register Volume 86, Number 46 (Thursday, March 11, 2021)]
[Rules and Regulations]
[Pages 13814-13816]
[FR Doc No: 2021-05199]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0025; Project Identifier MCAI-2020-01248-R;
Amendment 39-21422; AD 2021-04-01]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Leonardo S.p.a. (Leonardo) Model AB139 and AW139 helicopters.
This AD requires removing certain forward facing center seats (seats).
This AD was prompted by a design deficiency that affects seats on
certain main cabin floor installations. The actions of this AD are
intended to address an unsafe condition on these products.

DATES: This AD becomes effective March 26, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of March 26, 2021.
    The FAA must receive comments on this AD by April 26, 2021.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

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-
0025; 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 AD, the European Union Aviation Safety Agency (EASA) AD, any
service information that is incorporated by reference, any comments
received, and other information. The street address for Docket
Operations is listed above. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this final rule, contact
Leonardo S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. You may view the referenced service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. It is
also available on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0025.

FOR FURTHER INFORMATION CONTACT: John Miller, Aviation Safety Engineer,
Certification Section, Fort Worth ACO Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include the docket number FAA-2021-0025 and Project
Identifier MCAI-2020-01248-R at the beginning of your comments. The
most helpful comments reference a specific portion of the final rule,
explain the reason for any recommended change, and include supporting
data. The FAA will consider all comments received by the closing date
and may amend this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and

that is relevant or responsive to this AD, it is important that you
clearly designate the submitted comments as CBI. Please mark each page
of your submission containing CBI as ``PROPIN.'' The FAA will treat
such marked submissions as confidential under the FOIA, and they will
not be placed in the public docket of this AD. Submissions containing
CBI should be sent to John Miller, Aviation Safety Engineer,
Certification Section, Fort Worth ACO Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued AD No. 2020-0191, dated September 4, 2020
(EASA AD 2020-0191), to correct an unsafe condition for Leonardo Model
AB139 and AW139 helicopters, serial number (S/N) 31400 to 31882
inclusive, and S/N 41300 to 41570 inclusive, if a passenger cabin floor
is installed, composed of 3 panels, and with the first row central
seat(s) facing forward. EASA advises that a design deficiency has been
identified that affects some specific main cabin floor panel
installations. EASA further advises that this condition, if not
corrected, could, in the case of an emergency landing, lead to failure
of the affected seats, possibly resulting in injury to helicopter
occupants. Accordingly, EASA AD 2020-0191 requires removing the
affected seats as identified by configuration in Leonardo Alert Service
Bulletin No. 139-633, Rev. A, dated September 2, 2020 (ASB 139-633).
The EASA AD also provides an alternative to the seat removal for
configurations which require the removal of 2 seats, which consists of
modifying the helicopter to a different approved seating configuration.
EASA states its AD is considered an interim action and further AD
action may follow.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all information provided by EASA and determining the unsafe
condition exists and is likely to exist or develop on other helicopters
of these same type designs.

Related Service Information Under 1 CFR Part 51

    Leonardo has issued ASB 139-633, which specifies removing the seats
of all the affected cabin configurations.
    This service information 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.

AD Requirements

    This AD requires removing each seat within 50 hours time-in-service
(TIS).

Interim Action

    The FAA considers this AD to be an interim action. The design
approval holder is currently developing a modification that will
address the unsafe condition identified in this AD. Once this
modification is developed, approved, and available, the FAA might
consider additional rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 61 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates that operators may incur the following
costs in order to comply with this AD.
    Removing each affected seat takes about 1 work-hour for an
estimated cost of $85 per seat and up to $10,370 for the U.S. fleet.
There would be no parts costs.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.)
authorizes agencies to dispense with notice and comment procedures for
rules when the agency, for ``good cause'' finds that those procedures
are ``impracticable, unnecessary, or contrary to the public interest.''
Under this section, an agency, upon finding good cause, may issue a
final rule without seeking comment prior to the rulemaking.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because removing each seat is required within 50 hours TIS, which is a
short compliance time for these high usage helicopters, some of which
could reach these hours within 45 calendar days. Therefore, notice and
opportunity for prior public comment are impracticable and contrary to
public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the
reasons stated above, the FAA finds that good cause exists pursuant to
5 U.S.C. 553(d) for making this amendment effective in less than 30
days.

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

    The FAA determined that 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, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866, and
    2. Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of 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:

2021-04-01 Leonardo S.p.a.: Amendment 39-21422; Docket No. FAA-2021-
0025; Project Identifier MCAI-2020-01248-R.

(a) Applicability

    This Airworthiness Directive (AD) applies to Leonardo S.p.a.
(Leonardo) Model AB139 and AW139 helicopters, serial number (S/N)
31400 through 31882 inclusive, and S/N 41300 through 41570
inclusive, certificated in any category, with one or two forward
facing first row center seat/seats (seat) and a cabin floor composed
of 3 panels, and identified by configuration in Figures 1 through 13
of Leonardo Alert Service Bulletin No. 139-633, Rev. A, dated
September 2, 2020 (ASB 139-633) installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a design deficiency,
which if not corrected, could lead to failure of the seat during an
emergency landing and subsequent injury to a helicopter occupant.

(c) Affected ADs

    None.

(d) Effective Date

    This AD becomes effective March 26, 2021.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Action

    Remove each seat within 50 hours time-in-service.

(g) Special Flight Permits

    A special flight permit may be permitted provided that there is
no passenger in the seat.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, FAA, may
approve AMOCs for this AD. Send your proposal to: Manager, Strategic
Policy Rotorcraft Section, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(i) Additional Information

    The subject of this AD is addressed in European Union Aviation
Safety Agency (EASA) AD No. 2020-0191, dated September 4, 2020. You
may view the EASA AD on the internet at https://www.regulations.gov
by searching for and locating it in Docket No. FAA-2021-0025.

(j) Subject

    Joint Aircraft Service Component (JASC) Code: 2500 Cabin
Equipment/Furnishings.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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 the AD specifies otherwise.
    (i) Leonardo Alert Service Bulletin No. 139-633, Rev. A, dated
September 2, 2020.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Leonardo S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home.
    (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>.
    (5) You may view this service information 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 February 1, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-05199 Filed 3-9-21; 2:00 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41473-41475]
[FR Doc No: 2012-17115]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Proposed Technical Standard Order (TSO)-C126b, 406 MHz Emergency
Locator Transmitters (ELT) and Notice of Intent To Withdraw TSO
Authorizations (TSOA) for TSO-C91a, Emergency Locator Transmitter (ELT)
Equipment, and TSO-C126/C126a, 406 MHz Emergency Locator Transmitters
(ELT)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of availability and request for public comment.

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SUMMARY: This notice announces the availability of proposed TSO-C126b
and the FAA's intent to withdraw TSO authorizations (TSOA) issued for
the manufacture of automatic fixed (AF) and automatic portable (AP)
ELTs under TSO-C91a, TSO-C126, and TSO-C126a which incorporate hook and
loop fasteners in their design. This proposed action would affect ELT
manufacturers. The FAA is not proposing requiring actions on previously
installed ELTs. The FAA is taking this action based on its
determination that hook and loop fasteners are not an acceptable means
of compliance to meet the mounting and retention requirements of
current TSOs for ELTs. The FAA is requesting comment on proposed TSO-
C126b and the FAA's proposal to withdraw certain other ELT TSOAs.

DATES: Comments must be received on or before September 11, 2012.

FOR FURTHER INFORMATION CONTACT: Ms. Charisse Green, AIR-130, Federal
Aviation Administration, 470 L'Enfant Plaza, Suite 4102, Washington, DC
20024. Telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, email to:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    You are invited to comment on proposed TSO-C126b and the proposed
withdrawal of TSOAs for the manufacture of automatic fixed (AF) and
automatic portable (AP) ELTs under TSO-C91a, TSO-C126, and TSO-C126a
which incorporate hook and loop fasteners in their design by submitting
written data, views, or arguments to the address specified in FOR
FURTHER INFORMATION CONTACT. If you propose alternate actions, please
provide detailed information on your alternative and indicate whether
the information you provide is proprietary. Comments received may be
examined, both before and after the closing date at Federal

Aviation Administration, 470 L'Enfant Plaza, Suite 4102, Washington, DC
20024., weekdays except Federal holidays, between 8:30 a.m. and 4:30
p.m. The Director, Aircraft Certification Service, will consider all
comments received on or before the closing date.

Background

    In several recent aircraft accidents, ELTs mounted with hook and
loop fasteners, commonly referred to as Velcro[supreg], have detached
from their aircraft mounting tray. The separation of the ELT from its
mounting tray has caused the antenna connection to sever, rendering the
ELT ineffective and severely impacting the performance of the TSO'd
ELT.
    Section 347 of the FAA Modernization and Reform Act of 2012 (Pub.
L. 112-95) requires the FAA to determine if the ELT mounting
requirements and retention tests specified by TSO-C91a and TSO-C126 are
adequate to assess retention capabilities in ELT designs. Based on that
determination, the Act requires the Administrator to make any necessary
revisions to the requirements and retention tests to ensure that ELTs
are properly retained in the event of an aircraft accident.

Evaluation of ELT Mounting Requirements and Retention Tests

    The FAA evaluated the mounting requirements and retention tests
specified in TSO-C91a, TSO-C126 and TSO-C126a. These TSOs specifically
address ELT mounting and require the mounting design to meet certain
specifications; however, they do not require or preclude any specific
type of retention mechanism. Based upon its evaluation, the FAA has
determined that the standards contained in these TSOs do not adequately
address the use of hook and loop fasteners. While these types of
fasteners can meet the TSO requirements for retention forces in
laboratory conditions, accident investigations have found these
fasteners are not reliable in service.
    Recent accident data reveals hook and loop fasteners have failed to
retain the ELT in its mount. The following three documents describe
specific accidents in which an ELT failed to remain its mount after an
accident:
    (1) NTSB Aircraft Accident Report AAR-11-03: The antenna cable was
severed from the ELT when the ELT slipped out of the hook and loop
fastener which retained the ELT to the installed mount. The ELT
functioned properly during post accident testing by the manufacturer
and NTSB. As a result of its investigation the NTSB made safety
recommendation A-10-170 to the FAA which stated: ``Determine if the
emergency locator transmitter mounting requirements and retention tests
specified by TSO-C91a and TSO-C126a are adequate to assess retention
capabilities in ELT designs. Based on the results of this
determination, revise, as necessary, TSO requirements to ensure proper
retention of ELTs during airplane accidents.''
    (2) NTSB Factual Report--Aviation NTSB ID WPR10FA273: The antenna
cable was severed from the ELT when the ELT slipped out of the hook and
loop fastener which retained the ELT to the installed mount. The ELT
functioned but without the antenna the transmissions were not strong
enough to be received by the search and rescue satellites.
    (3) Transportation Safety Board of Canada Aviation Safety Advisory
A11W0151-D1-A2, Loose Attachment of Kannad 406 AF-Compact (ER) ELT.
This advisory highlights an October 2011 Cessna 208B accident where
inadequate installation of the hook and loop fastener resulted in the
ELT sliding out of its mount, disconnecting from the antenna cable, and
failing to perform its intended function.
    Both government and industry guidance material discourages the use
of hook and loop fasteners and notes potential difficulties with their
use in ELT mounting. Advisory material discouraging the use of hook and
loop fasteners includes the following:
    (1) Advisory Circular AC 91-44A, Operational and Maintenance
Practices for Emergency Locator Transmitters and Receivers, paragraph
6.a., states that attachment of ELTs solely by means of Velcro[supreg]
strips and other flexible materials is not considered satisfactory
since the ``g'' switches may fail to operate or the equipment may come
out of its mounting resulting in damage to the ELT and possible damage
to the antenna or antenna coaxial cable.
    (2) RTCA DO-DO-182, Emergency Locator Transmitter (ELT) Equipment
Installation and Performance, section 1.2 a., states that ELTs secured
with Velcro[supreg] strips are an improper installation.
    (3) NASA Technical Memorandum-81960, Evaluation of Emergency-
Locator-Transmitter Performance in Real and Simulated Crash Tests,
states: ``Typical mounts can vary from sturdy mounts, to mounts using
Velcro[supreg], plastic ties, and mounts on non-airframe structure in
the airplanes. This diversity in mounting techniques include improper
and/or inadequate mounting of many ELT's and is likely to be one source
of problems of nonfunctioning and/or false activations of some units.''

FAA Concerns

    After completing its evaluation of the use of hook and loop
fasteners for ELT retention the agency identified the following
concerns:
    (1) Hook and loop fasteners fail to retain the ELT when
insufficient tension is applied when closing the fastener. There is no
repeatable method for installation and no method to evaluate the
tension of the hook and loop fastener. The allowance for pilots to
secure ELTs to the aircraft when changing ELT batteries further
increases the potential for inconsistent and unsatisfactory
installations.
    (2) Hook and loop fasteners closed with proper tension may stretch
or loosen over time due to wear, fluids, vibration, and use leading to
insufficient tension to retain the ELT.
    (3) Hook and loop fasteners closed with proper tension do not
provide stated retention capability due to debris which can contaminate
the hooks and loops of the fastener.
    (4) Hook and loop fasteners closed with proper tension degrade due
to environmental factors such as repeated heating and cooling cycles,
temperature extremes, and contamination resulting from location in
equipment areas.
    Safety Awareness Information Bulletin (SAIB) HQ-12-32, Hook and
Loop Style Fasteners as a Mounting Mechanism for Emergency Locator
Transmitters, was issued May 23, 2012 to bring immediate attention to
this issue. It outlines actions ELT manufacturers can take to improve
their installation and maintenance instructions to mitigate the
concerns with hook and loop ELT retention.

Determination

    The FAA has determined that hook and loop fasteners are not an
acceptable means of compliance to meet the mounting and retention
requirements of the current ELT TSOs.

Proposed Actions

    Based on its evaluation, the FAA proposes to:
    (1) Issue TSO-C126b which would preclude the use of hook and loop
fasteners as a means of securing an ELT in its mounting tray.
    (2) Withdraw TSO authorizations issued for the manufacture of ELTs
under TSO-C91a, TSO-C126 and TSO-C126a, which incorporate hook and loop
fasteners into their design unless the design is revised to replace the
hook and loop fastener with an alternative

acceptable to the FAA before June 30, 2014.
    (3) Withdraw TSO authorizations issued for the manufacture of ELTs
under TSO-C91a, TSO-C126, and TSO-C126a, which incorporate hook and
loop fasteners into their design unless the installation and
maintenance instructions for the article are revised to include the
following information by June 30, 2013:
    a. Detailed instructions for properly securing the ELT during
installation and reinstallation, as well as a method to determine the
appropriate tension of the hook and loop style fasteners. Revised
instructions will provide improved guidance on the proper installation
of ELTs for owners and operators in the interim period before an
enhanced mounting design is available, and for owners and operators who
choose not to install the enhanced mounting design when it is
available.
    b. Detailed instructions for inspecting the hook and loop style
fasteners for wear, contamination, environmental degradation, and other
effects to ensure they meet the standards of the applicable TSO.
    c. A replacement interval for the hook and loop style fasteners.
    (4) Encourage owners and operators to install the manufacturer's
proposed updated mounting designs in accordance with the revised
maintenance and installation instructions.

How To Obtain Copies

    You can view or download TSOs C91a, C126, C126a by logging onto
http://rgl.faa.gov and select Technical Standard Order, and the
proposed TSO-C126b may be found at http://www.faa.gov/aircraft/draft_docs/tso/. For a paper copy of the documents, contact the person listed
in FOR FURTHER INFORMATION CONTACT.

    Issued in Washington, DC, on July 10, 2012.
Susan J. M. Cabler,
Assistant Manager, Aircraft Engineering Division, Aircraft
Certification Service.
[FR Doc. 2012-17115 Filed 7-12-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Rules and Regulations]
[Pages 17556-17561]
[FR Doc No: 2011-7465]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0097; FRL-8867-7]

Sodium Ferric Ethylenediaminetetraacetate; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sodium ferric
ethylenediaminetetraacetate (EDTA) in or on all food commodities when
applied as a molluscicide and used in accordance with good agricultural
practices. W. Neudorff GmbH KG submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from

the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of sodium ferric
EDTA under the FFDCA.

DATES: This regulation is effective March 30, 2011. Objections and
requests for hearings must be received on or before May 31, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0097. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: John Fournier, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://www.epa.gov/oscpp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0097 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 31, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0097, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of September 30, 2010 (75 FR 60452) (FRL-
8837-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9F7668) by W. Neudorff GmbH KG, An der M[uuml]hle 3,
Postfach 1209, 31860 Emmerthal, Germany (c/o Walter G. Talarek, P.C.,
1008 Riva Ridge Dr., Great Falls, VA 22066-1620). The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of sodium ferric EDTA.
This notice referenced a summary of the petition prepared by the
petitioner, W. Neudorff GmbH KG, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information

concerning the cumulative effects of a particular pesticide's
residues'' and ``other substances that have a common mechanism of
toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

A. Overview of Sodium Ferric EDTA

    The pesticidal active ingredient, sodium ferric EDTA, is a
molluscicide that has historically been used to control terrestrial
slugs and snails in agriculture and on ornamental landscaping. The
compound is comprised of iron in a sodium chelate. This chelate forms a
soluble, complex molecule with iron ions, inactivating the ions so that
they cannot normally react with other elements or ions to produce
precipitates or scale. In this form, the iron is more bioavailable than
in other mineral sources (Ref. 1). Bioavailability of iron is an
essential quality of sodium ferric EDTA as the iron in this compound is
responsible for controlling slugs and snails. That is, when slugs or
snails ingest sodium ferric EDTA, the iron in the compound interacts
with hemocyanin, a copper-based respiratory protein common to the blood
of mollusks and responsible for their oxygen transport. This
interaction with hemocyanin causes suffocation and eventually results
in the death of slugs and snails. Iron does not have this interaction,
however, in organisms that do not use hemocyanin for oxygen transport
(e.g., mammals).
    Iron is a necessary nutrient for all mammals and other vertebrates
because it is a component of hemoglobin, the oxygen transport protein
found in red blood cells of vertebrates. It is the most abundant
element on Earth and, as such, can be found in most soil and water. It
is an essential nutrient listed as Generally Recognized as Safe (GRAS)
by the Food and Drug Administration (FDA) for direct addition to food
(21 CFR 184.1375) and is added to commonly consumed, fortified foods
such as enriched flour, bread, pasta, and grains. Sodium Ferric EDTA is
allowed as a direct food additive by the FDA and is used as a source of
iron for nutritional fortification in foods such as powdered meal
replacements, flavored milk, and fruit-flavored beverages (Ref. 2), as
well as soy, fish, teriyaki, and hoisin sauces (Ref. 3). The compound
is also a common constituent of many cosmetic products and, despite
being present at much higher concentrations than those found in sodium
ferric EDTA end-use pesticide products used for control of slugs and
snails, has an extensive history of safe use as an agricultural
fertilizer.
    In 2008, EPA registered the first sodium ferric EDTA-containing
product for control of slugs and snails. EPA assessed the risks to
human health and concluded that, when sodium ferric EDTA was used in
accordance with widespread and commonly recognized practices, no
unreasonable adverse effects on the environment were expected (Ref. 4).
At the time of this initial sodium ferric EDTA registration, the
applicant did not petition EPA to establish a tolerance or tolerance
exemption because all uses were non-food. On December 6, 2009, however,
EPA was petitioned by W. Neudorff GmbH KG to establish an exemption
from the requirement of a tolerance for residues of sodium ferric EDTA
in or on all food commodities. Accordingly, EPA has completed a risk
assessment of mammalian toxicology data submitted in support of this
request. The overall conclusions from these data are described in Unit
III.B., while more in-depth synopses of the study results can be found
in the risk assessment and Biopesticides Registration Action Document
provided as references in Unit IX. (Refs. 5 and 6).

B. Biochemical Pesticide Human Health Assessment Data Requirements

    1. Acute toxicity. Tier I acute toxicity studies of technical grade
sodium ferric EDTA (Slugkil MP, containing 71.42% sodium ferric EDTA)
showed that the active ingredient is a Toxicity Category III (slightly
toxic) compound via the oral and dermal routes of exposure, a Toxicity
Category III (slightly irritating) compound via the dermal and eye
routes of exposure, and a Toxicity Category IV (practically nontoxic)
compound for inhalation exposure. Moreover, sodium ferric EDTA is not a
dermal sensitizer. Given the results of these studies, no additional
toxicity (i.e., Tiers II or III) or residue data are required to
support food uses of this biochemical active ingredient. These acute
toxicity studies confirm sodium ferric EDTA's low toxicity profile.
    i. The acute oral median lethal dose (LD50) for sodium
ferric EDTA in rats was greater than 2,000 milligrams per kilogram (mg/
kg) and confirmed low toxicity through oral exposure (Master Record
Identification Number (MRID No.) 47942507). Sodium Ferric EDTA is
classified as Toxicity Category III for acute oral toxicity.
    ii. The acute dermal LD50 for sodium ferric EDTA in rats
was greater than 2,000 mg/kg, which confirmed low dermal toxicity (MRID
No. 47942508). Sodium Ferric EDTA is classified as Toxicity Category
III for acute dermal toxicity.
    iii. The acute inhalation median lethal concentration
(LC50) for sodium ferric EDTA in rats was greater than 2.75
milligrams per liter (mg/L) and showed practically no inhalation
toxicity (MRID No. 47942512). Sodium Ferric EDTA is classified as
Toxicity Category IV for acute inhalation toxicity.
    iv. A primary eye irritation study showed that exposure to sodium
ferric EDTA will cause temporary, mild eye irritation (MRID No.
47942509). Accordingly, EPA has determined that sodium ferric EDTA is
Toxicity Category III for primary eye irritation.
    v. A primary dermal irritation study showed that exposure to sodium
ferric EDTA is slightly irritating (MRID No. 47942510) and a skin
sensitization study showed that sodium ferric EDTA is not a sensitizer
to the skin (MRID No. 47942511). Accordingly, EPA has determined that
sodium ferric EDTA is Toxicity Category III for dermal irritation.
    2. Subchronic toxicity.--i. Submission of 90-day oral toxicity data
was waived by EPA because the acute oral toxicity study demonstrated
sodium ferric EDTA's low toxicity (LD50 >2,000 .mg/kg). In
their waiver rationale, the petitioner also cited information from
EPA's 2008 sodium ferric EDTA Biopesticides Registration Action
Document (BRAD):

    No references for feeding studies using sodium ferric EDTA were
located in the published literature. Rats fed low mineral diets with
or without calcium disodium EDTA for four months had reduced weight
gain, but their general condition was comparable to that of controls
(Ref. 7). Rats fed 1%, 5%, or 10% disodium salt of EDTA for 90 days
had significantly lower food consumption and weight gain than
controls (Ref. 8). Hematology was comparable among all groups,
except that prothrombin time was increased in the 10% group. The
only significant necropsy finding was pale livers in the 10% group.

    Mice fed 3,750 or 7,500 ppm trisodium EDTA for 103 weeks had no
treatment-related clinical signs, and gross and microscopic
pathology were unremarkable (Ref. 9). A companion study conducted by
NCI using rats produced the same results (Ref. 9). In a 12-month
feeding study using dogs, Oser et al (1963) found no significant
changes in hematology or urinalysis parameters, and no abnormal
gross or microscopic findings in groups receiving up to 250 mg/kg
body weight/day of calcium disodium EDTA (Ref. 10).
    The information cited above refers to feeding studies using
sodium EDTA and calcium disodium EDTA. The Agency has assessed the
toxicity profile of these and other EDTA salts (Refs. 11 and 12),
and concluded that they are closely related. This information
sufficed for the assessment of toxicological risk characterization
of sodium ferric EDTA.

    Additionally, iron is an essential nutrient listed as GRAS by the
FDA, and both iron and sodium ferric EDTA are allowed as direct food
additives to increase the nutritional content of food and food
supplements. Sodium Ferric EDTA is also used in agriculture as a
fertilizer. Given all of this information, EPA concluded that no
subchronic oral toxicity is expected when this compound is used in
accordance with good agricultural practices.
    ii. Submission of 90-day dermal toxicity data was waived by EPA
because acute guideline studies demonstrated that sodium ferric EDTA
has low dermal toxicity (LD50 >2,000 mg/kg), is a slight
dermal irritant, and is not a dermal sensitizer. Repeated dermal
exposure, under conditions of product use at a concentration that could
be toxic, is not anticipated.
    iii. Submission of 90-day inhalation data was waived by EPA because
the acute inhalation toxicity study demonstrated sodium ferric EDTA's
lack of toxicity (Toxicity Category IV). Repeated inhalation exposure,
under conditions of product use at a concentration that could be toxic,
is not anticipated.
    3. Developmental toxicity and mutagenicity. Acceptable waiver
requests were submitted to address the data requirements for
Developmental toxicity and Mutagenicity (OPPTS 870.3700). The Agency
concluded that humans are regularly exposed to iron found abundantly in
nature and from the use of sodium ferric EDTA as fertilizer. No
negative effects of sodium ferric EDTA have been reported because of
its low toxicity and low water solubility, which decreases its
absorption in the intestine. Moreover, the active ingredient is not a
mutagen nor is it related to any known classes of mutagens. After
considering the aforementioned information and the extensive history of
use of sodium ferric EDTA in agriculture and food without deleterious
effects, EPA waived the requirement to submit developmental toxicity
and mutagenicity data.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    1. Food. The primary route of sodium ferric EDTA exposure to the
general population will be through consumption of food; however, there
is no reason to expect that practical use of sodium ferric EDTA, in
accordance with good agricultural practices, will constitute any
significant hazard.
    Sodium Ferric EDTA is comprised of iron in a sodium chelate. Iron
is abundant in nature, an essential nutrient, and listed as GRAS for
direct addition to food (21 CFR 184.1375). Sodium Ferric EDTA is
regarded as safe for use as a dietary supplement to increase iron
bioavailability and prevent iron deficiency. In humans, iron is an
essential nutrient that is vital to the processes by which cells
generate energy. It is available to animals from food derived from
other animals and plants.
    When sodium ferric EDTA is ingested, the chelate holds the iron in
the stomach until pH rises in the upper small intestine. As pH rises,
the strength of the complex progressively diminishes, allowing exchange
with other metals and iron for absorption. Iron dissociates from the
EDTA moiety and is released in the duodenum prior to absorption. Only a
very small fraction of the sodium ferric EDTA complex (less than 1%) is
absorbed intact. Intact EDTA metal complexes are rapidly excreted; they
do not accumulate or undergo biotransformation (Ref. 13).
    European Food Safety Authority Panel on Food Additives and Nutrient
Sources added to Food (2010) concluded that, when sodium ferric EDTA is
used in food supplements at levels that provide 22.3 milligrams (mg) of
iron/day for adults and 11.1 mg of iron/day for children, the use of
sodium ferric EDTA as a source of iron in foods is of no safety concern
as long as it does not lead to an exposure of EDTA above 1.9 mg/kg/day.
    Exposure to EDTA and salts of EDTA already occurs through certain
FDA-approved uses as food additives, in sanitizing solutions, and in
pharmaceutical products, or through their use in soaps, shampoos, or
cosmetics. EDTA has also been administered safely under medical
supervision as treatment for heavy metal poisoning. The results of
toxicity testing and information found in public literature indicate
that there is no risk to human health from residues of sodium ferric
EDTA in food crops. Furthermore, residues from the formulations in
agricultural use sites (certified limits <4% by weight) and residential
use sites (<1% of typical formulations) are not likely to exceed levels
currently consumed in commonly eaten foods. In addition, the use of
EDTA and EDTA salts in pesticide products is expected to result in much
lower exposure than the FDA-regulated use of these compounds, as well
as lower exposure than their use in pharmaceuticals or cosmetic
products.
    The concentration of iron needed for good plant growth is below the
concentration needed by animals for good cellular functioning. In
agriculture, iron sodium chelate is used as micronutrient fertilizer at
much higher concentrations than those present in sodium ferric EDTA-
containing pesticide products, which are labeled for maximum
application rates of below 25 mg of sodium ferric EDTA per square foot.
The use of sodium ferric EDTA in pesticides is expected to result in
much lower exposure than through its use in plant fertilizers,
pharmaceutical products, or cosmetic products. Based on review and
evaluation of available information, EPA concludes that there is a
reasonable certainty of no harm from residues of sodium ferric EDTA
when applied as a molluscicide and used in accordance with good
agricultural practices.
    2. Drinking water exposure. No significant drinking water exposure
or residues are expected to result from the use of sodium ferric EDTA
as a molluscicide. The active ingredient is intended for use directly
on food commodities or the soil around crops and is not to be applied
directly to water. If used in accordance with EPA-approved labeling and
good agricultural practices, sodium ferric EDTA is not likely to
accumulate in drinking water. Overall, exposures from residues in
drinking water are unlikely and are not expected to pose a quantifiable
risk due to environmental fate of sodium ferric

EDTA and lack of residues of toxicological concerns.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure of the general population,
including infants and children, is limited based on the use patterns of
sodium ferric EDTA. The end use products containing sodium ferric EDTA
are granules or pellets that do not produce any dust and are applied
directly to the ground. Therefore, it is unlikely that there will be
any dermal or inhalation exposure when the product is applied according
to the label use directions. Furthermore, sodium ferric EDTA was
demonstrated to be practically non-toxic (Toxicity Category IV) to rats
in an acute dermal toxicity guideline study (MRID 45848104) and
practically non-toxic (Toxicity Category IV) to rats in an acute
inhalation toxicity guideline study (MRID 45848105). Non-dietary
exposures are not expected to pose any quantifiable risk to the general
population.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found sodium ferric EDTA to share a common mechanism of
toxicity with any other substances, and sodium ferric EDTA does not
appear to produce a toxic metabolite as its mode of action against the
target pests. For the purposes of this tolerance action, therefore, EPA
has assumed that sodium ferric EDTA does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments
either directly or through the use of a margin of exposure analysis, or
by using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk.
    Based on the results of the toxicological data discussed in Unit
III.B., as well as all other available information, EPA concludes that
there is a reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
the residues of sodium ferric EDTA. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. EPA has arrived at this conclusion based on the low level
of toxicity of the compound, the minimal exposure from application/use
of sodium ferric EDTA as a molluscicide, and the already widespread
exposure through use as a fertilizer and food additive without any
reported adverse effects on human health. Thus, there are no threshold
effects of concern and, as a result, an additional margin of safety is
not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for sodium ferric EDTA.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of sodium ferric EDTA. Therefore,
an exemption is established for residues of sodium ferric EDTA in or on
all food commodities when applied as a molluscicide and used in
accordance with good agricultural practices.

IX. References

1. Heimbach J, Rieth S, Mohamedshah F, Slesinski R, Samuel-Fernando
P, Sheehan T, Dickmann R, Borzelleca J. 2000. Safety assessment of
iron EDTA sodium ion (Fe(3+)) ethylenediaminetetraacetic acid:
Summary of toxicological, fortification and exposure data. Food
Chemical Toxicology 38(1):99-111.
2. U.S. FDA. 2006 Agency Response Letter GRAS Notice No. GRN 000178
(Sodium Iron EDTA). Available from: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154622.htm.
3. U.S. FDA. 2004. Agency Response Letter GRAS Notice No. GRN 000152
(Sodium Iron EDTA). Available from: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154378.htm.
4. U.S. EPA. 2008. Sodium Ferric EDTA Biopesticides Registration
Action document dated November 20, 2008.
5. U.S. EPA. 2011. Dietary Risk Assessment (Ferric Sodium EDTA).
Memorandum from C. Fuentes, PhD to J. Fournier dated January 5,
2011.
6. U.S. EPA. 2011. Sodium Ferric EDTA Biopesticides Registration
Action Document dated February 7, 2011 (available as ``Supporting &
Related Materials'' within Docket Number EPA-HQ-OPP-2010-0144 at
http://www.regulations.gov).
7. Yang SS. 1964. Toxicology of EDTA. Food Cosmetics Toxicology
2:763-765.
8. Wynn JE, Van't Riet B, Borzelleca JF. 1970. The toxicity and
pharmacodynamics of EGTA: oral administration to rats and
comparisons with EDTA. Toxicology Applied Pharmacology 16(3):807-
817.
9. National Cancer Institute. 1977. Bioassay of trisodium
ethylenediaminetetraacetate trihydrate (EDTA) for possible
carcinogenicity: CAS No. 150-38-9. Bethesda (MD): National Cancer
Institute, Carcinogenesis Program/Research Triangle Park (NC):
National

Toxicology Program (NTP); Technical Report Series No. 11.
10. Oser BL, Oser M, Spencer HC. 1963. Safety evaluation studies of
calcium EDTA. Toxicology Applied Pharmacology 5:142-162.
11. U.S. EPA. 2004. Recommendation for Tolerance Reassessment for
Ethylenediaminetetraacetic Acid (EDTA) and various ammonium,
calcium, copper, iron, potassium, manganese, sodium and zinc salts
of EDTA. Memorandum from K. Boyle to B. Shackleford dated January
28, 2004.
12. U.S. EPA. 2004. Ethylenediaminetetraacetic acid (EDTA) and the
salts of EDTA: Science Assessment Document for Tolerance
Reassessment. Memorandum from E. Reaves to K. Boyle dated January
26, 2004.
13. European Food Safety Authority Panel on Food Additives and
Nutrient Sources added to Food 2010. Scientific opinion on the use
of ferric sodium EDTA as a source of iron added for nutritional
purposes to foods for the general population (including food
supplements) and to foods for particular nutritional uses. EFSA
Journal 8(1):1414.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children From Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions To Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 17, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1302 is added to subpart D to read as follows:

Sec.  180.1302  Sodium Ferric Ethylenediaminetetraacetate (EDTA);
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of sodium ferric EDTA in or on all food commodities when
applied as a molluscicide and used in accordance with good agricultural
practices.

[FR Doc. 2011-7465 Filed 3-29-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68128-68129]
[FR Doc No: 2012-27723]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1106]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishing and Maintaining a List of U.S. Dairy
Product Manufacturers/Processors With Interest in Exporting to Chile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the guidance document entitled ``Establishing and
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With
Interest in Exporting to Chile.''

DATES: Submit either electronic or written comments on the collection
of information by January 14, 2013.

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

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Establishing and Maintaining a List of U.S. Dairy Product
Manufacturers/Processors With Interest in Exporting to Chile (OMB
Control Number 0910-0509)--Extension

    As a direct result of discussions that have been adjunct to the
U.S./Chile Free Trade Agreement, Chile has recognized FDA as the
competent U.S. food safety authority and has accepted the U.S.
regulatory system for dairy inspections. Chile has concluded that it
will not require individual inspections of U.S. firms by Chile as a
prerequisite for trade, but will accept firms identified by FDA as
eligible to export to Chile. Therefore, in the Federal Register of June
22, 2005 (70 FR 36190), FDA announced the availability of a revised
guidance document entitled ``Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/Processors With Interest in Exporting
to Chile.'' The guidance can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ImportsExports/ucm078936.htm. The guidance document explains that FDA
has established a list that is provided to the government of Chile and
posted on http://www.fda.gov/Food/InternationalActivities/Exports/ucm120245.htm, which identifies U.S. dairy product manufacturers/
processors that have expressed interest to FDA in exporting dairy
products to Chile, are subject to FDA jurisdiction, and are not the
subject of a pending judicial enforcement action (i.e., an injunction
or seizure) or a pending warning letter. The term ``dairy products,''
for purposes of this list, is not intended to cover the raw
agricultural commodity raw milk. Application for inclusion on the list
is voluntary. However, Chile has advised that dairy products from firms
not on this list could be delayed or prevented by Chilean authorities
from entering commerce in Chile. The guidance explains what information
firms should submit to FDA in order to be considered for inclusion on
the list and what criteria FDA intends to use to determine eligibility
for placement on the list. The document also explains how FDA intends
to update the list and how FDA intends to communicate any new
information to Chile. Finally, the guidance notes that FDA considers
the information on this list, which is provided voluntarily with the
understanding that it will be posted on FDA's Web site and communicated
to, and possibly further disseminated by, Chile, to be information that
is not protected from disclosure under 5 U.S.C. 552(b)(4). Under the
guidance, FDA recommends that U.S. firms that want to be placed on the
list send the following information to FDA: Name and address of the
firm and the manufacturing plant; name, telephone number, and email
address (if available) of the contact person; a list of products
presently shipped and expected to be shipped in the next 3 years;
identities of agencies that inspect the plant and the date of last
inspection; plant number and copy of last inspection notice; and, if
other than an FDA inspection, copy of last inspection report. FDA
requests that this information be updated every 2 years.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
New written requests to be                    25               1              25             1.5              38
 placed on the list.............
Biannual update.................              88               1              88             1.0              88
Occasional updates..............              25               1              25             0.5              13
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             139
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the number of firms that will submit new written
requests to be placed on the list, biannual updates, and occasional
updates is based on FDA's experience maintaining the list over the past
7 years. The estimate of the number of hours that it will take a firm
to gather the information needed to be placed on the list or update its
information is based on FDA's experience with firms submitting similar
requests. FDA believes that the information to be submitted will be
readily available to the firms.
    On average, over the last 3 years, the list contained approximately
176 firms. FDA estimates that, each year, approximately 25 new firms
will apply to be added to the list. In any given year, some firms
choose not to resubmit their information. These firms are removed from
the list quarterly. This occurrence results in the number of firms to
remain at approximately 176. We estimate that a firm will require 1.5
hours to read the guidance, gather the information needed, and to
prepare a communication to FDA that contains the information and
requests that the firm be placed on the list for a total of 37.5 hours,
rounded to 38. Under the guidance, every 2 years each producer on the
list must provide updated information in order to remain on the list.
FDA estimates that each year approximately half of the firms on the
list, 88 firms (176 x 0.5 = 88), will resubmit the information to
remain on the list. We estimate that a firm already on the list will
require 1.0 hours to biannually update and resubmit the information to
FDA, including time reviewing the information and corresponding with
FDA, for a total of 88 hours. In addition, FDA expects that, each year,
approximately 25 firms will need to submit an occasional update and
each firm will require 0.5 hours to prepare a communication to FDA
reporting the change, for a total of 12.5 hours, rounded to 13.

    Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27723 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Notices]
[Pages 41777-41778]
[FR Doc No: 2011-17838]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1760-002; ER10-1758-002.
    Applicants: Carolina Power & Light Company, Florida Power
Corporation,
    Description: Progress Companies submits its triennial market power
update for their market-based rate authorizations.
    Filed Date: 06/30/2011,
    Accession Number: 20110706-0202,
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-3547-002.
    Applicants: RG Steel Sparrows Point LLC.
    Description: RG Steel Sparrows Point LLC submits tariff filing per
35.17(b): RG Steel MBRA ETariff adj to be effective 7/6/2011.
    Filed Date: 07/06/2011.
    Accession Number: 20110706-5001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 27, 2011.

    Docket Numbers: ER11-3607-001.
    Applicants: AEP Texas North Company.
    Description: AEP Texas North Company submits tariff filing per
35.17(b): TNC-PSO-ETT IA Refiling to be effective 5/19/2011.
    Filed Date: 07/06/2011.
    Accession Number: 20110706-5026.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 27, 2011.
    Docket Numbers: ER11-4003-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: SGIA WDT SERV AG SCE-GPS 2510/2580 W.
Walnut Ave Rialto Roof Top Solar Project to be effective 7/7/2011.
    Filed Date: 07/06/2011.
    Accession Number: 20110706-5039.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 27, 2011.

    Docket Numbers: ER11-4004-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: LGIA Among NYISO, NYPA and Noble
Clinton Windpark to be effective 6/20/2011.
    Filed Date: 07/06/2011.
    Accession Number: 20110706-5085.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 27, 2011.

    Docket Numbers: ER11-4005-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: LGIA Among NYISO, NYPA and Noble
Ellinburg to be effective 6/20/2011.
    Filed Date: 07/06/2011.
    Accession Number: 20110706-5094.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 27, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to

notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 6, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-17838 Filed 7-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Notices]
[Pages 59345-59347]
[FR Doc No: 2013-23509]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2003-0033; FRL-9901-42-OW]

Proposed Information Collection Request; Comment Request;
Modification of Secondary Treatment Requirements for Discharges Into
Marine Waters (Renewal)

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), ``Modification of Secondary
Treatment Requirements for Discharges into Marine Waters (Renewal)''
(EPA ICR No. 0138.09, OMB Control No. 2040-0088) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act (PRA) (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 Information Collection Request (ICR), which
is currently approved through 01/31/2014''. 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 November 25, 2013.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-2003-
0033, online using www.regulations.gov (our preferred method), by email
to<EMAIL_ADDRESS>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: Virginia Fox-Norse, Oceans and Coastal
Protection Division, Office of Water, (4504T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; 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, EPA 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: Regulations implementing section 301(h) of the Clean
Water Act (CWA) are found at 40 CFR Part 125, Subpart G. The section
301(h) program involves collecting information from two sources: (1)
The municipal wastewater treatment facility, commonly called a publicly
owned treatment works (POTW), and (2) the state in which the POTW is
located. Municipalities had the opportunity to apply for a waiver from
secondary treatment requirements, but that opportunity closed in
December, 1982. A POTW holding a current waiver or reapplying for a
waiver provides application, monitoring, and toxic control program
information. The state provides information on its determination
whether the discharge under the proposed conditions of the waiver
ensures the protection of water quality, biological habitats, and
beneficial uses of receiving waters and whether the discharge will
result in additional treatment, pollution control, or any other
requirement for any other point or nonpoint sources. The state also
provides information to certify that the discharge will meet all
applicable state laws and that the state accepts all permit conditions.
    There are 4 situations where information will be required under the
section 301(h) program:
    (1) A POTW reapplying for a section 301(h) waiver. As the permits
with section 301(h) waivers reach their expiration dates, EPA must have
updated information on the discharge to determine whether the section
301(h) criteria are still being met and whether the section 301(h)
waiver should be reissued. Under 40 CFR 125.59(f), each section 301(h)
permittee is required to submit an application for a new section 301(h)
modified permit within 180 days of the existing permit's expiration
date. 40 CFR 125.59(c) lists the information required for a modified
permit. The information that EPA needs to determine whether the POTW's
reapplication meets the section 301(h) criteria is outlined in the
questionnaire attached to 40 CFR Part 125, Subpart G.
    (2) Monitoring and toxic control program information: Once a waiver
has been granted, EPA must continue to assess whether the discharge is
meeting section 301(h) criteria, and that the receiving water quality,
biological habitats, and beneficial uses of the receiving waters are
protected. To do this, EPA needs monitoring information furnished by
the permittee. According to 40 CFR 125.68(d), any permit issued with a
section 301(h) waiver must contain the monitoring requirements of 40
CFR 125.63(b), (c), and (d) for biomonitoring, water quality criteria
and standards monitoring, and effluent monitoring, respectively.
Section 125.68(d) also requires reporting at the frequency specified in
the monitoring program. In addition to monitoring information, EPA
needs information on the toxics control program required by section
125.66 to ensure that the permittee is effectively minimizing
industrial and nonindustrial toxic pollutant and pesticide discharges
into the treatment works.
    (3) Application revision information: Section 125.59(d) of 40 CFR
allows a POTW to revise its application one time only, following a
tentative decision by EPA to deny the waiver request. In its
application revision, the POTW usually corrects deficiencies and
changes proposed treatment levels as well as outfall and diffuser
locations. The application revision is a voluntary submission for the
applicant, and a letter of intent to revise the application must be
submitted within 45 days of EPA's tentative decision (40 CFR
125.59(f)). EPA needs this information to evaluate revised applications
to determine whether the modified discharge will ensure protection of
water quality, biological habitats, and beneficial uses of receiving
waters.
    (4) State determination and state certification information: For
revised or renewal applications for section 301(h) waivers, EPA needs a
state determination. The state determines whether all state laws
(including water quality standards) are satisfied. This helps ensure
that water quality, biological habitats, and beneficial uses of
receiving waters are protected. Additionally, the state must determine
if the applicant's discharge will result in additional treatment,
pollution control, or any other requirement for any other point or
nonpoint sources. This process allows the state's views to be taken
into account when EPA reviews the section 301(h) application and
develops permit conditions. For revised and renewed section 301(h)
waiver applications, EPA also needs the CWA section 401(a)(1)
certification information to ensure that all state water quality laws
are met by any permit it issues with a section 301(h) modification, and
the state accepts all the permit conditions. This information is the
means by which the state can exercise its authority to concur

with or deny a section 301(h) decision made by the EPA Regional Office.
    Form Numbers: ``None.''
    Respondents/affected Entities: Entities potentially affected by
this action are those municipalities that currently have section 301(h)
waivers from secondary treatment, or have applied for a renewal of a
section 301(h) waiver, and the states within which these municipalities
are located.
    Respondent's Obligation To Respond: Required To Obtain or retain a
benefit.
    Estimated Number of Respondents: Est. 50 (total).
    Frequency of Response: From once every five years, to varies case-
by-case, depending on the category of information.
    Total Estimated Burden: 59,370 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total Estimated Cost: $1.3 million (per year), includes $0
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. EPA expects the numbers will decrease due to changes in respondent
universe, use of technology, etc.

    Dated: September 18, 2013.
Benita Best-Wong,
Acting Director, Office of Wetlands, Oceans and Watersheds.
[FR Doc. 2013-23509 Filed 9-25-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Pages 32663-32664]
[FR Doc No: 2018-14981]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-149-000]

Notice of Institution of Section 206 Proceeding and Refund
Effective Date: PSEG Energy Resources & Trade, LLC

    On July 9, 2018, the Commission issued an order in Docket No. EL18-
149-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into whether PSEG
Energy Resources & Trade, LLC's rates for Reactive Service may be
unjust and unreasonable. PSEG Energy Resources & Trade, LLC, 164 FERC
61,018 (2018).
    The refund effective date in Docket No. EL18-149-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL18-149-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory

Commission, 888 First Street NE, Washington, DC 20426, in accordance
with Rule 214 of the Commission's Rules of Practice and Procedure, 18
CFR 385.214, within 21 days of the date of issuance of the order.

    Dated: July 9, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-14981 Filed 7-12-18; 8:45 am]
 BILLING CODE 6717-01-P