[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Rules and Regulations]
[Pages 48957-48961]
[FR Doc No: 2014-18906]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1158; Directorate Identifier 2011-NM-232-AD;
Amendment 39-17501; AD 2013-13-13]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A310 series airplanes; and Model A300 B4-600, B4-600R, and
F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes
(collectively called A300-600 series airplanes). This AD was prompted
by the revision of certain airworthiness limitation items (ALI)
documents, which require more restrictive maintenance requirements and
airworthiness limitations. This AD requires revising the maintenance or
inspection program to incorporate the limitations section. We are
issuing this AD to prevent fatigue cracking, damage, or corrosion in
principal structural elements, which could result in reduced structural
integrity of the airplane.

DATES: This AD becomes effective September 23, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of September 23,
2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2012-1158 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36

96; fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A300 and
A310 series airplanes; and Model A300 B4-600, B4-600R, and F4-600R
series airplanes, and Model A300 C4-605R Variant F airplanes
(collectively called A300-600 series airplanes). The NPRM was intended
to supersede AD 2011-10-17, Amendment 39-16698 (76 FR 27875, May 13,
2011). The NPRM published in the Federal Register on November 7, 2012
(77 FR 66772). The NPRM was prompted by the revision of certain
airworthiness limitation items (ALI) documents, which require more
restrictive maintenance requirements and airworthiness limitations. The
NPRM proposed to require revising the maintenance program to
incorporate the limitations section. We are issuing this AD to prevent
fatigue cracking, damage, or corrosion in principal structural
elements, which could result in reduced structural integrity of the
airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, issued EASA
Airworthiness Directive 2011-0198, dated October 19, 2011 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition all Airbus Model A300 and
A310 series airplanes; and Model A300 B4-600, B4-600R, and F4-600R
series airplanes, and Model A300 C4-605R Variant F airplanes
(collectively called A300-600 series airplanes). The MCAI states:

    The airworthiness limitations applicable to the Damage Tolerant
Airworthiness Limitation Items (DT ALIs) are currently listed in
Airbus ALI Documents, which are referenced in the A300, A310 and
A300-600 Airworthiness Limitations Section (ALS) Part 2.
    Airbus have recently revised the A300-600 and A310 ALI
Documents, and these issues have been approved by EASA. The Airbus
A300-600 ALI Document issue 13 and temporary revision (TR) 13.1 and
the A310 ALI document issue 08 introduce more restrictive
maintenance requirements and airworthiness limitations, which have
been identified as mandatory actions for continued airworthiness.
    EASA AD 2009-0155 [which corresponds to FAA AD 2011-10-17,
Amendment 39-16698 (76 FR 27875, May 13, 2011)] required compliance
with the maintenance requirements and associated airworthiness
limitations defined in the following documents:

--AIRBUS A300 ALI Document issue 04,
--AIRBUS A310 ALI Document issue 07, and
--AIRBUS A300-600 ALI Document issue 12.

    For the reasons described, this EASA AD retains the requirements
of EASA AD 2009-0155, which is superseded, and requires compliance
with the airworthiness limitations defined in the Airbus A300-600
ALI Document issue 13 and TR13.1, and the A310 ALI document issue
08.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2012-1158-0002.

Actions Since NPRM (77 FR 66772, November 7, 2012)

    The NPRM (77 FR 66772, November 7, 2012) proposed to supersede AD
2011-10-17, Amendment 39-16698 (76 FR 27875, May 13, 2011). However,
the new actions introduced in the NPRM and required by this final rule
apply only to Model A310 and A300-600 series airplanes. The actions
required for Model A300 series airplanes that are required by AD 2011-
10-17 are not affected by this AD. AD 2011-10-17 therefore remains in
effect in its entirety for Model A300, A300-600, and A310 series
airplanes. The requirements of this final rule include only the new
actions, and apply only to Model A310 and A300-600 series airplanes.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received.

Request for Clarification of Compliance Times

    UPS requested clarification of the compliance times for the
maintenance program revision and the initial inspection. UPS noted that
operators have 3 months to complete both the maintenance program
revision and the initial inspections. UPS stated that the current
wording indicates that the two tasks are to be accomplished
concurrently, and cannot be accomplished until approved by the
principal maintenance inspector. UPS added that concurrent
accomplishment of the two actions is not feasible and requested that
accomplishment of these two actions be consecutive rather than
concurrent.
    We agree to provide clarification. The commenter's statement that
operators have 3 months to complete both the maintenance program
revision and initial inspections is not accurate. As specified in
paragraph (g) of this AD, operators have 3 months to revise the
maintenance or inspection program, as applicable. However, the
compliance time for the initial inspections is at the times in the
applicable service information identified in paragraphs (g)(1),
(g)(1)(i)(A), and (g)(2) of this AD, or within 3 months after the
effective date of this AD, whichever occurs later.
    For the service information identified in paragraphs (g)(1) and
(g)(2) of this AD, there are also compliance times specified in
paragraph 3., ``Special Compliance Times,'' in the ``Record of
Revisions'' section of the service information, which provide
compliance times relative to the approval date or publication date of
the service information. We have determined that those compliance times
should be relative to the effective date of this AD; therefore, we have
added compliance time exceptions to paragraphs (g)(1)(i)(B) and
(g)(2)(i) of this AD. We have determined that extending these
compliance times will provide an acceptable level of safety.

Request To Extend Grace Period and Repetitive Intervals

    UPS requested that the proposed grace period and repetitive
intervals be extended to be equivalent to the requirements of AD 2011-
10-17, Amendment 39-16698 (76 FR 27875, May 13, 2011). UPS commented
that the proposed compliance times are overly conservative and are not
supported by industry data.
    We do not agree with the commenter's request to extend the grace
period and repetitive intervals. Airbus revised the ALIs based upon
analysis and data. Under the provisions of paragraph (j) of this final
rule, however, we will consider requests for approval of an extension
of the compliance time if sufficient data are submitted to substantiate
that a different compliance time would provide an acceptable level of
safety. We have not changed this final rule in this regard.

``Contacting the Manufacturer'' Paragraph in This AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the

FAA develops an AD based on a foreign authority's AD.
    We have become aware that some operators have misunderstood or
misinterpreted the Airworthy Product paragraph to allow the owner/
operator to use messages provided by the manufacturer as approval of
deviations during the accomplishment of an AD-mandated action. The
Airworthy Product paragraph does not approve messages or other
information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed the paragraph and retitled
it ``Contacting the Manufacturer.'' This paragraph now clarifies that
for any requirement in this AD to obtain corrective actions from a
manufacturer, the action must be accomplished using a method approved
by the FAA, the European Aviation Safety Agency (EASA), or Airbus's
EASA DOA.
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    We also have decided not to include a generic reference to either
the ``delegated agent'' or ``design approval holder (DAH) with State of
Design Authority design organization approval,'' but instead we have
provided the specific delegation approval granted by the State of
Design Authority for the DAH throughout this AD.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 66772, November 7, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 66772, November 7, 2012).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 170 airplanes of U.S. registry.
    We estimate that it will take about 1 work-hour per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $14,450, or $85 per product.

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.
    We are 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

    We 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 above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2012-1158; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

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 (AD):

2013-13-13 Airbus Airplanes: Amendment 39-17501. Docket No. FAA-
2012-1158; Directorate Identifier 2011-NM-232-AD.

(a) Effective Date

    This AD becomes effective September 23, 2014.

(b) Affected ADs

    This AD affects AD 2011-10-17, Amendment 39-16698 (76 FR 27875,
May 13, 2011).

(c) Applicability

    This AD applies to all Airbus model airplanes identified in
paragraphs (c)(1) and (c)(2) of this AD, certificated in any
category.
    (1) Model A310-203, -204, -221, -222, 304, -322, -324, and -325
airplanes.
    (2) Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R,
F4-605R, F4-622R, and C4-605R Variant F airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by revisions of certain Airbus
Airworthiness Limitation Items (ALI) documents, which require more
restrictive maintenance requirements and airworthiness limitations.
We are issuing this AD to prevent fatigue cracking, damage, or
corrosion in principal structural elements, which could result in
reduced structural integrity of the airplane.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    (1) For Model A300-600 series airplanes: Within 3 months after
the effective date of this AD, revise the maintenance or inspection
program, as applicable, to incorporate the structural inspections
and inspection intervals defined in Airbus A300-600 Airworthiness
Limitation Items Document AI/SE-M2/95A.1310/07, Issue 13, dated
October 2010. The initial compliance time for accomplishing the
inspections is at the later of the times specified in paragraphs
(g)(1)(i) and (g)(1)(ii) of this AD.
    (i) At the applicable times specified in Airbus A300-600
Airworthiness Limitation Items Document AI/SE-M2/95A.1310/07, Issue
13, dated October 2010, except as specified in paragraphs
(g)(1)(i)(A) and (g)(1)(i)(B) of this AD.
    (A) For actions identified in Airbus A300-600 Airworthiness
Limitation Items Document AI/SE-M2/95A.1310/07, Issue 13, dated
October 2010; and Airbus TR 13.1, dated February 2011, to the Airbus
A300-600 Airworthiness Limitation Items Document AI/SE-M2/95A.1310/
07, Issue 13, dated October 2010: Use the applicable compliance time
specified in Airbus Temporary Revision (TR) 13.1, dated February
2011, to the Airbus A300-600 Airworthiness Limitation Items Document
AI/SE-M2/95A.1310/07, Issue 13, dated October 2010.
    (B) Where compliance times in paragraph 3., ``Special Compliance
Times,'' in the ``Record of Revisions'' section of Airbus A300-600
Airworthiness Limitation Items Document AI/SE-M2/95A.1310/07,
specify ``from approval date of A300-600 ALI Document Issue 13,''
``from date approval of A300-600 ALI Document Issue 13,'' or ``from
A300-600 ALI Document Issue date of publication,'' for this AD use
``after the effective date of this AD'' for those compliance times.
    (ii) Within 3 months after the effective date of this AD.
    (2) For Model A310 series airplanes: Within 3 months after the
effective date of this AD, revise the maintenance or inspection
program, as applicable, to incorporate the structural inspections
and inspection intervals defined in Airbus A310 Airworthiness
Limitation Items Document AI/SE-M2/95A.1309/07, Issue 8, dated
October 2010. The initial compliance time for accomplishing the
inspections is at the later of the times specified in paragraph
(g)(2)(i) and (g)(2)(ii) of this AD.
    (i) At the applicable times specified in Airbus A310
Airworthiness Limitation Items Document AI/SE-M2/95A.1309/07, Issue
8, dated October 2010; except where compliance times in paragraph
3., ``Special Compliance Times,'' in the ``Record of Revisions''
section of Airbus A310 Airworthiness Limitation Items Document AI/
SE-M2/95A.1309/07, Issue 8, dated October 2010, specify ``from date
of approval of ALI Document Issue 8,'' or ``from date approval of
the ALI document Issue 8,'' for this AD use ``after the effective
date of this AD'' for those compliance times.
    (ii) Within 3 months after the effective date of this AD.

(h) Terminating Action for AD 2011-10-17, Amendment 39-16698 (76 FR
27875, May 13, 2011)

    Accomplishing the revision required by paragraph (g) of this AD
terminates the actions required by paragraph (s) of AD 2011-10-17,
Amendment 39-16698 (76 FR 27875, May 13, 2011) for that airplane
only.

(i) New Alternative Inspections and Inspection Intervals Limitation

    After accomplishing the revision required by paragraph (g) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used unless the actions or intervals are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (j) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA Airworthiness Directive 2011-0198, dated October 19, 2011, for
related information. You may examine the MCAI in the AD docket on
the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-
2012-1158-0002.

(l) 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) Airbus A300-600 Airworthiness Limitation Items Document AI/
SE-M2/95A.1310/07, Issue 13, dated October 2010.
    (ii) Airbus A310 Airworthiness Limitation Items Document AI/SE-
M2/95A.1309/07, Issue 8, dated October 2010. Page APXD-362 (which
contains Illustration 2 of 2 of Figure 575141) of this document does
not contain an issue date or page number.
    (iii) Airbus Temporary Revision 13.1, dated February 2011, to
Airbus A300-600 Airworthiness Limitation Items Document AI/SE-M2/
95A.1310/07, Issue 13, dated October 2010.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 30, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-18906 Filed 8-18-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Page 68841]
[FR Doc No: 2023-21923]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-556, OMB Control No. 3235-0619]

Proposed Collection; Comment Request; Extension: Rule 163

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736
    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 163 (17 CFR 230.163) provides an exemption from Section 5(c)
under the Securities Act of 1933 (15 U.S.C. 77a et seq.) for certain
communications by or on behalf of a well-known seasoned issuer. The
information filed under Rule 163 is publicly available. We estimate
that it takes approximately 0.375 burden hours per response to provide
the information required under Rule 163 and that the information is
filed by approximately 12 respondents for a total annual reporting
burden of one hour. We estimate that 25% of 0.375 hours per response
(0.09375 hours) is prepared by the respondent for a total annual burden
of 1 hour (0.09375 hours per response x 12 responses).
    Written comments are invited on: (a) whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication by December 4, 2023.
    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 control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street, NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: September 28, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-21923 Filed 10-3-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Page 58813]
[FR Doc No: 2011-24317]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0271]

Guidance for Industry; Measures to Address the Risk for
Contamination by Salmonella Species in Food Containing a Pistachio-
Derived Product as an Ingredient; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: Measures
to Address the Risk for Contamination by Salmonella Species in Food
Containing a Pistachio-Derived Product as an Ingredient.'' The guidance
clarifies for manufacturers who produce foods containing a pistachio-
derived product as an ingredient that there is a risk that Salmonella
species may be present in the incoming pistachio-derived product, and
recommends measures to address that risk.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Plant and Dairy Food Safety, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive
labels to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 29, 2009 (74 FR 31038), FDA
announced the availability of a draft guidance entitled ``Guidance for
Industry: Measures to Address the Risk for Contamination by Salmonella
Species in Food Containing a Pistachio-Derived Product as an
Ingredient'' and gave interested parties an opportunity to submit
comments by August 28, 2009. The Agency reviewed and evaluated these
comments and has modified the guidance where appropriate.
    The guidance clarifies for manufacturers who produce foods
containing a pistachio-derived product as an ingredient that there is a
risk that Salmonella species may be present in the incoming pistachio-
derived product, and recommends measures to address that risk.
Pistachio-derived products include roasted in-shell pistachios and
shelled pistachios (also called kernels) that are roasted or raw. FDA
is issuing this guidance as level 1 guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's current thinking on measures to address the risk for
contamination by Salmonella spp. in food containing a pistachio-derived
product as an ingredient. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternate approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: September 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24317 Filed 9-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 227 (Monday, November 26, 2018)]
[Notices]
[Page 60424]
[FR Doc No: 2018-25672]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0047; FRL-9985-96-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Municipal Solid Waste Landfills
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for Municipal Solid Waste
Landfills (EPA ICR No. 1557.10, OMB Control No. 2060-0220), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through November 30,
2018. Public comments were previously requested, via the Federal
Register on June 29, 2017, during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before December 26,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0047, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    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: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

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.
    Abstract: The New Source Performance Standards (NSPS) for Municipal
Solid Waste (MSW) apply to MSW landfills for which construction,
modification, or reconstruction commences either on or after May 30,
1991. A MSW landfill is an entire disposal facility in a contiguous
geographical space where household waste is placed in or on. An MSW
landfill may also receive other types of RCRA Subtitle D wastes (Sec.
257.2 of this title) such as commercial solid waste, nonhazardous
sludge, conditionally exempt small quantity generator waste, and
industrial solid waste. Portions of an MSW landfill may be separated by
access roads. An MSW landfill may be publicly or privately owned, and
may be a new landfill, an existing landfill, or a lateral expansion.
    On August 29, 2016 (81 FR 59332), EPA finalized a new NSPS subpart
(40 CFR part 60, subpart XXX) based on its review of subpart WWW.
Concurrently, EPA finalized revised Emissions Guidelines under a new
subpart (40 CFR part 60, subpart Cf). The new Emission Guidelines apply
to existing landfills accepting waste after 1987 for which construction
was commenced either on or before July 17, 2014. Subpart XXX applies to
MSW landfills that are new, reconstructed, or modified after July 17,
2014. The requirements in Subpart WWW mimic most of the requirements in
these new rules, except for that the control threshold in new rules
require controls at additional landfills beyond what Subpart WWW
requires.
    In general, all NSPS standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance with 40 CFR part 60,
subpart WWW.
    Form Numbers: None.
    Respondents/affected entities: Municipal Solid Waste (MSW)
Landfills.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart WWW).
    Estimated number of respondents: 661 (total).
    Frequency of response: Annually.
    Total estimated burden: 760 hours (per year). Burden is defined at
5 CFR 1320.3(b).
    Total estimated cost: $86,600 (per year); there are no annualized
capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is a decrease in the burden hours
and the Capital/O&M costs in this ICR compared to the previous ICR. The
change in burden and cost estimates occurred as a result of the 2016
NSPS (40 CFR part 60, subpart XXX) and Emissions Guidelines (40 CFR
part 60, subpart Cf). Most of the burden previously attributed to the
ICR for subpart WWW has been accounted for in the 2016 ICRs for both
subparts XXX (ICR 2498.03, OMB 2060-0697) and Cf (ICR 2522.02, OMB
2060-0720) to avoid duplication of burden for identical requirements.
There is an increase in number of responses compared to the previous
ICR. While this ICR does not duplicate responses for the 2016 ICRs,
each respondent was counted as a respondent that does not report but
maintains records under subpart WWW and this resulted in an increase
number of responses.

Courtney Kerwin,
 Director, Regulatory Support Division.
[FR Doc. 2018-25672 Filed 11-23-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 8 (Tuesday, January 13, 2015)]
[Notices]
[Page 1680]
[FR Doc No: 2015-00293]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension: Rule 11a1-1(T) SEC File No. 270-428, OMB Control No.
3235-0478.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information provided for in Rule 11a1-1(T) (17 CFR 240.11a1-1(T)),
under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.). The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    On January 27, 1976, the Commission adopted Rule 11a1-1(T)--
Transactions Yielding Priority, Parity, and Precedence (17 CFR
240.11a1-1(T)) under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.) (``Exchange Act''), to exempt certain transactions of exchange
members for their own accounts that would otherwise be prohibited under
Section 11(a) of the Exchange Act. The rule provides that a member's
proprietary order may be executed on the exchange of which the trader
is a member, if, among other things: (1) The member discloses that a
bid or offer for its account is for its account to any member with whom
such bid or offer is placed or to whom it is communicated; (2) any such
member through whom that bid or offer is communicated discloses to
others participating in effecting the order that it is for the account
of a member; and (3) immediately before executing the order, a member
(other than a specialist in such security) presenting any order for the
account of a member on the exchange clearly announces or otherwise
indicates to the specialist and to other members then present that he
is presenting an order for the account of a member.
    Without these requirements, it would not be possible for the
Commission to monitor its mandate under the Exchange Act to promote
fair and orderly markets and ensure that exchange members have, as the
principal purpose of their exchange memberships, the conduct of a
public securities business.
    There are approximately 663 respondents that require an aggregate
total of 19 hours to comply with this rule. Each of these approximately
663 respondents makes an estimated 20 annual responses, for an
aggregate of 13,260 responses per year. Each response takes
approximately 5 seconds to complete. Thus, the total compliance burden
per year is 19 hours (13,260 x 5 seconds/60 seconds per minute/60
minutes per hour = 19 hours). The approximate cost per hour is $323,
resulting in a total cost of compliance for the annual burden of $6,137
(19 hours @$323).
    Written comments are invited on: (a) 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; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send
an email to<EMAIL_ADDRESS>
    Dated: January 7, 2015.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2015-00293 Filed 1-12-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Rules and Regulations]
[Pages 79705-79708]
[FR Doc No: 2015-32170]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0700; FRL-9939-39]

Ammonium Acetate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ammonium acetate (CAS No. 631-61-8) when
used as an inert ingredient (buffering agent) limited to 15% in
pesticide formulations applied to pre-harvested crops. Exponent Inc.,
1150 Connecticut Ave., Suite 1100, Washington, DC 20036 on behalf of
the Gowan Company LLC., 370 South Main Street, Yuma, AZ 85364 submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of ammonium acetate.

DATES: This regulation is effective December 23, 2015. Objections and
requests for hearings must be received on or before February 22, 2016,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0700, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number:<PHONE_NUMBER>; email
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2013-0700 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
February 22, 2016. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0700, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of December 30, 2013 (78 FR79359) (FRL-
9903-69), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10604) by Exponent Inc., 1150 Connecticut Ave., Suite 1100, Washington,
DC 20036, on behalf of the Gowan Company LLC., 370 South Main Street,
Yuma, AZ 85364. The petition requested that 40 CFR 180.920 be amended
by establishing an exemption from the requirement of a tolerance for
residues of ammonium acetate (CAS No. 631-61-8) when used as an inert
ingredient in pesticide formulations applied to crops pre-harvest and
limited to 15% in pesticide formulations. That document referenced a
summary of the petition prepared by Exponent Inc., on behalf of the
Gowan Company LLC, the petitioner, which is available in the docket,
http://www.regulations.gov. No comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit V.C.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing

agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for ammonium acetate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with ammonium acetate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by ammonium acetate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies.
    Ammonium acetate is an ammonium salt of acetic acid. In aqueous
solutions acetic acid and its salt ammonium acetate dissociate into the
acetate anion (CH3COO-) and the respective cations (H+ and NH4+). The
cations and ammonia (also a human metabolite) are physiological
components of the human body. The chemical structures, physical-
chemical properties, environmental fate behavior, and aquatic and
mammalian toxicity of ammonium acetate and acetic acid are similar.
Since limited data are available on ammonium acetate, toxicity data on
acetic acid were used to represent toxicity due to exposure to ammonium
acetate.
    Acetic acid is of low acute dermal and inhalation toxicity in rats.
It causes dermal irritation in mice and is corrosive in rabbits. It was
also irritating in the eyes of rabbits. Although reduced body weight
was observed at 390 mg/kg/day in a 90-day oral toxicity study in the
rat, the reduction in weight gain was likely attributed to reduced
appetite and food consumption observed in the study. Therefore, this is
not considered an adverse effect. Although increased spleen weight was
observed at 23-31 ppm (equivalent to 15-19 mg/kg/day) of acetic acid in
a toxicity study in rats via the inhalation route of exposure, there is
no concern for potential immunotoxicity. The Agency considers that this
effect is due to red blood cell destruction rather than an immunotoxic
response. Fetal susceptibility was not observed in several
developmental studies in rats, mice and rabbits. Neither maternal nor
developmental toxicity was not observed up to 1,600 mg/kg/day. It is
not mutagenic in an Ames test nor is it clastogenic in a cytogenetic
assay with Chinese hamster ovary K1 cells. It is not carcinogenic. In
an eight month cancer study, tumors were not observed in rats at 60 mg/
kg/day. While evidence of potential neurotoxicity was observed in a
literature study in rats conducted by Sapute et al.\1\, a second study
in rats showed no indication of systemic toxicity, neurotoxicity,
neuropathological or histological lesions at the same dose that was
previously tested, 100 mg/kg/day. Since the second study (MRID
49703201) \2\ was conducted according to the Organization for Economic
Co-operation and Development (OECD) and good laboratory practice (GLP)
guidelines, it was considered to accurately represent the neurotoxic
potential for ammonium acetate.
---------------------------------------------------------------------------

    \1\ Satpute, R.M., Lomash, V., Hariharakrishnan, J., Roa, P.,
Singh, P., Gujar, N., and Bhattacharya, R. (2014). Oxidative Stress
and Tissue Pathology Caused By Subacute Exposure To Ammonium Acetate
In Rats And Their Response To Treatments With Alpha-Ketoglutarate
And N-Acetyl Cysteine. Toxicology and Industrial Health: 30(1) 12-
14. MRID. 49507001.
    \2\ Barnett, Jr., John F. (2015). A 28-Day Oral (Gavage)
Repeated Dose Study of Ammonium Acetate in Adult Rats. Laboratory
Project ID 20073669. Unpublished study prepared by Charles River
Laboratories. MRID 49703201.
---------------------------------------------------------------------------

    As noted above, acetic acid undergoes dissociation to the acetate
anion and the H+ cations in aqueous media at pHs commonly found in the
environment. Also, it is a naturally-occurring substance in plants and
animals. In aerobic metabolism, acetic acid (as acetate) is a
metabolite that combines with Co-enzyme A to form acetyl Co-A which
subsequently enters into the Citric Acid Cycle, a common metabolic
pathway in which food molecules are broken down to form energy. A major
function of the Citric Acid Cycle is the oxidation of acetate. In
animals, acetate is obtained from the breakdown of glucose molecules.
    Specific information on the studies received and the nature of the
adverse effects caused by acetic acid as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Ammonium Acetate; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2013-0700.

B. Toxicological Points of Departure/Levels of Concern

    In an aqueous environment, ammonium acetate dissociates to acetic
acid and its salt. Therefore, it is appropriate to expect toxicity due
to exposure to ammonium acetate to be similar to that of acetic acid.
Therefore, based on the absence of a toxicological endpoint of concern
via dietary route of exposure for acetic acid, its regulatory history,
and no new toxicological data to indicate concern regarding previous
decisions, a qualitative assessment was appropriate for ammonium
acetate for all pathways of human exposure (food, drinking water, and
residential). A potential endpoint of concern for the inhalation route
of exposure was identified in a toxicity study. Increased spleen weight
due to red blood cell destruction was observed at 23-31 ppm (equivalent
to 15-19 mg/kg/day) of acetic acid in rats. However, according to the
American Conference of Governmental Industrial Hygenists, Inc. (ACGIH),
the threshold limit value (TLV) for occupational exposure to acetic
acid is 10 ppm via inhalation. Residential exposure to the proposed use
of ammonium acetate via inhalation is not expected to exceed the TLV
limit of 10 ppm because the residential use pattern would result in
drastically lower opportunities for inhalation exposure than allowed
occupational use patterns, which are limited to 10 ppm. In addition,
residential exposure will be much lower because exposure is expected to
occur for shorter periods to diluted acetic acid as compared to workers
who are exposed for 8 hours continuously, to more concentrated acetic
acid. Therefore, a qualitative assessment was conducted with regard to
inhalation exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ammonium acetate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from ammonium acetate in food as follows:
    Under this exemption from the requirement of a tolerance, residues
of this ammonium acetate may be found on foods from crops that were
treated with pesticide formulations containing ammonium acetate.
However, a quantitative dietary exposure assessment was not conducted
since an endpoint for risk assessment was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted, although exposures may be expected
from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Ammonium acetate may be used in pesticide products and non-
pesticide products that may be used around the home. Based on the
discussion in Unit IV.B., a quantitative residential exposure
assessment for ammonium acetate was not conducted.
    4. 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 ammonium acetate to share a common mechanism of
toxicity with any other substances, and ammonium acetate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
ammonium acetate 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.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    As part of its qualitative assessment, the Agency did not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children. Based on an
assessment of ammonium acetate and its chemical properties, EPA has
concluded that there are no toxicological endpoints of concern for the
U.S. population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA
concludes that aggregate exposure to residues of ammonium acetate will
not pose a risk to the U.S. population, including infants and children,
and that there is a reasonable certainty that no harm will result to
the general population, or to infants and children from aggregate
exposure to ammonium acetate residues.

V. 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. EPA is establishing a limitation on the amount of ammonium
acetate that may be used in pesticide formulations. The limitation will
be enforced through the pesticide registration process under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et seq. EPA will not register any pesticide formulation used on
crops for sale or distribution containing ammonium acetate at ready for
use end-use concentrations exceeding 15%.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for ammonium acetate (CAS No. 631-61-
8) when used as an inert ingredient (buffering agent) in pesticide
formulations applied to crops pre-harvest and limited to 15% in the end
use formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), do not apply.
    This action 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 FFDCA section 408(n)(4). 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: December 11, 2015.
Susan Lewis,
Director, Registration Division, 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. In Sec.  180.920, add alphabetically the following inert ingredient
to the table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------

                              * * * * * * *
Ammonium acetate (CAS No. 631-61-              15%  Buffering Agent.
 8).

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-32170 Filed 12-22-15; 8:45 am]
 BILLING CODE 6560-50-P