[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Rules and Regulations]
[Pages 7106-7107]
[FR Doc No: 2011-2789]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2009-F-0525]

Food Additives Permitted in Feed and Drinking Water of Animals;
Formic Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for food additives permitted in feed and drinking water of
animals to provide for the safe use of formic acid as an acidifying
agent in swine feed. This action is in response to a food additive
petition filed by Kemira Oyj of Finland.

DATES: This rule is effective February 9, 2011. Submit either
electronic or written objections and requests for a hearing by March
11, 2011. See section V of this document for information on the filing
of objections.

ADDRESSES: You may submit either electronic or written objections and a
request for a hearing, identified by Docket No. FDA-2009-F-0525, by any
of the following methods:

Electronic Submissions

    Submit electronic objections in the following ways:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
    Fax:<PHONE_NUMBER>.
    Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2009-F-0525 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of December 7, 2009
(74 FR 64091), FDA announced that a food additive petition (animal use)
(FAP 2262) had been filed by Kemira Oyj, Porkkalantatu 3, P.O. Box 330,
001000 Helsinki, Finland. The petition proposed to amend the food
additive regulations to provide for the safe use of formic acid as an
acidifying agent at levels not to exceed 1.2 percent in swine feed. The
notice of filing provided for a 30-day comment period on the
petitioner's environmental assessment. One comment was received that
was not substantive.

II. Conclusion

    FDA concludes that the data establish the safety and utility of
formic acid for use as proposed with modification and that the food
additive regulations should be amended as set forth in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Veterinary Medicine by appointment with the information
contact person (see FOR FURTHER INFORMATION CONTACT). As provided in
Sec.  571.1(h), the Agency will delete from the documents materials
that are not available for public disclosure before making the
documents available for inspection.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.32(r) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections (see DATES). Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provision of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. It is only necessary to send one set of
documents. It is no longer necessary to send three copies of all
documents. Identify documents with the docket number found in brackets
in the heading of this document. Any objections received in response to
the regulation may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is
amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
1. The authority citation for 21 CFR part 573 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 348.

0
2. Revise Sec.  573.480 to read as follows:

Sec.  573.480  Formic acid.

    The food additive, formic acid, may be safely used in accordance
with the following conditions:
    (a) The additive is used as a preservative in hay crop silage in an
amount not to exceed 2.25 percent of

the silage on a dry weight basis or 0.45 percent when direct cut, as
follows:
    (1) The top foot of silage stored should not contain formic acid
and
    (2) Silage should not be fed to livestock within 4 weeks of
treatment.
    (b) The additive is used or intended for use as a feed acidifying
agent, to lower the pH, in complete swine feeds at levels not to exceed
1.2 percent of the complete feed.
    (1) The additive consists of not less than 85 percent formic acid
(CAS 64-18-6).
    (2) The additive meets the following specifications:
    (i) Free methyl alcohol not to exceed 1,000 parts per million
(ppm);
    (ii) Methyl formate not to exceed 1,000 ppm; and
    (iii) Moisture not to exceed 15 percent.
    (3) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug and Cosmetic Act, the
label and labeling shall contain:
    (i) The name of the additive.
    (ii) Adequate directions for use including a statement that formic
acid must be uniformly applied and thoroughly mixed into complete swine
feeds and that the complete swine feeds so treated shall be labeled as
containing formic acid.
    (4) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act and
paragraph (b)(3) of this section, the label and labeling shall contain:
    (i) Appropriate warnings and safety precautions concerning formic
acid (85 percent formic acid).
    (ii) Statements identifying formic acid (85 percent formic acid) as
a corrosive and possible severe irritant.
    (iii) Information about emergency aid in case of accidental
exposure.
    (A) Statements reflecting requirements of applicable sections of
the Superfund Amendments and Reauthorization Act (SARA), and the
Occupational Safety and Health Administration's (OSHA) human safety
guidance regulations.
    (B) Contact address and telephone number for reporting adverse
reactions or to request a copy of the Material Safety Data Sheet
(MSDS).

    Dated: February 3, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-2789 Filed 2-8-11; 8:45 am]
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[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Proposed Rules]
[Page 42804-42807]
[DOCID:fr25au09-16]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0717; Directorate Identifier 2009-NM-002-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Following scheduled maintenance, an A310 operator reported
finding cracks around the wing top skin panels fastener holes at Rib
2 (LH or RH) [left-hand or right-hand], between stringers 2 and 14
on some of its aircraft.
    This condition, if not corrected, may lead to degradation of the
structure in this area. An inspection programme is necessary to
restore and retain the structural integrity.
* * * * *
    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by September 24,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airbus SAS-EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; e-mail<EMAIL_ADDRESS>Internet
http://www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0717;
Directorate Identifier 2009-NM-002-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency, which is the Technical Agent
for the Member States of the European Community, has issued EASA
Airworthiness Directive 2008-0211, dated December 4, 2008 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Following scheduled maintenance, an A310 operator reported
finding cracks around the wing top skin panels fastener holes at Rib
2 (LH or RH) [left-hand or right-hand], between stringers 2 and 14
on some of its aircraft.
    This condition, if not corrected, may lead to degradation of the
structure in this area. An inspection programme is necessary to
restore and retain the structural integrity.
    For the reason described above, this AD requires the
implementation of an inspection programme that will ensure that any
visible cracks in the wing top skin panels 1 and 2 along Rib 2 are
detected in time and repaired appropriately.
    Note: The General Visual Inspection requested by the existing
and applicable Airworthiness Limitation Items (ALI) tasks may not be
adequate to detect these cracks.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Mandatory Service Bulletin A310-57-2096, dated
May 6, 2008. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 66 products of U.S. registry. We also estimate that
it would take about 2 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $10,560, or $160 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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2009-0717; Directorate Identifier 2009-NM-
002-AD.

Comments Due Date

    (a) We must receive comments by September 24, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A310-203, -204, -221, -222,
-304, -322, -324, and -325 airplanes; certificated in any category.

Subject

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

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Following scheduled maintenance, an A310 operator reported
finding cracks around the wing top skin panels fastener holes at Rib
2 (LH or RH) [left-hand or right-hand], between stringers 2 and 14
on some of its aircraft.
    This condition, if not corrected, may lead to degradation of the
structure in this area. An inspection programme is necessary to
restore and retain the structural integrity.
    For the reason described above, this AD requires the
implementation of an inspection programme that will ensure that any
visible cracks in the wing top skin panels 1 and 2 along Rib 2 are
detected in time and repaired appropriately.
    Note: The General Visual Inspection requested by the existing
and applicable Airworthiness Limitation Items (ALI) tasks may not be
adequate to detect these cracks.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Do a detailed visual inspection around fastener holes in the
wing top skin panels 1 and 2, along rib 2 between the right side and
left side of the front and rear spars, at the applicable compliance
time in Table 1 of this AD; as applicable to the airplane model and
Short Range (SR) use, average flight time (AFT) equal to or less
than 4 hours; or Long Range (LR) use, AFT exceeding 4 hours; in
accordance with the Accomplishment Instructions of Airbus Mandatory
Service Bulletin A310-57-2096, dated May 6, 2008.

    Note 1: To establish the AFT, take the accumulated flight time
(counted from the take-off up to the landing) and divide by the
number of accumulated flight cycles. This gives the average flight
time per flight cycle.

        Table 1--Compliance Times for Detailed Visual Inspection
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            Model               Compliance time (whichever occurs later)
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(i) A310-203, A310-204,        (A) Prior to the accumulation of 18,700
 A310[dash]221, and A310-222    flight cycles or 37,400 flight hours
 airplanes.                     since first flight of the airplane,
                                whichever occurs first; or
                               (B) Within 430 flight cycles or 860
                                flight hours, whichever occurs first,
                                after the effective date of this AD.
(ii) `SR' A310-304, A310-322,  (A) Prior to the accumulation of 17,300
 A310-324, and A310-325 short   flight cycles or 48,400 flight hours
 range airplanes.               since first flight of the airplane,
                                whichever occurs first; or
                               (B) Within 400 flight cycles or 1,100
                                flight hours, whichever occurs first,
                                after the effective date of this AD.
(iii) `LR' A310-304, A310-     (A) Prior to accumulation of 12,800
 322, A310[dash]324, and A310-  flight cycles or 64,300 flight hours
 325 long range airplanes.      since first flight of the airplane,
                                whichever occurs first; or
                               (B) Within 300 flight cycles or 1,450
                                flight hours, whichever occurs first,
                                after the effective date of this AD.
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     (2) As of the effective date of this AD, if any repair has
already been done as a result of finding skin cracks at rib 2 in the
area to be inspected, the inspection requirements of this AD are not
required for the repaired area. Instead, for previously repaired
areas, continue the inspection in accordance with the procedures
specified in paragraph (g) of this AD. The rest of the rib 2 area
not covered by the repair must be inspected in accordance with the
requirements of this AD.
    (3) If no crack is found, repeat the inspection required by
paragraph (f)(1) of this AD thereafter at the intervals not to
exceed those specified in Table 2 of this AD, as applicable.

      Table 2--Compliance Times for Repetitive Inspection Interval
------------------------------------------------------------------------
               Model                    Repetitive inspection interval
------------------------------------------------------------------------
A310-203, A310-204, A310[dash]221,   Within 1,700 flight cycles or 3,500
 and A310-222 airplanes.              flight hours, whichever occurs
                                      first.
`SR' A310-304, A310-322, A310-324,   Within 1,600 flight cycles or 4,600
 and A310-325 short range airplanes.  flight hours, whichever occurs
                                      first.
`LR' A310-304, A310-322,             Within 1,200 flight cycles or 6,100
 A310[dash]324, and A310-325 long     flight hours, whichever occurs
 range airplanes.                     first.
------------------------------------------------------------------------

     (4) If any crack is found during any inspection required by
paragraph (f)(1) or (f)(3) of this AD, before further flight, repair
in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A310-57-2096, dated May 6, 2008. Instead,
for previously repaired areas, continue the inspection in accordance
with the procedures specified in paragraph (g) of this AD.
    (5) After each inspection required by this AD, submit an
inspection report in accordance with Airbus Mandatory Service
Bulletin A310-57-2096, dated May 6, 2008; at the times specified in
paragraphs (f)(5)(i) or (f)(5)(ii) of this AD, as applicable.
    (i) If the inspection was done after the effective date of this
AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was accomplished prior to the effective
date of this AD: Submit the report within 30 days after the
effective date of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Dan
Rodina, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your principal maintenance inspector (PMI) or principal
avionics inspector (PAI), as appropriate, or lacking a principal
inspector, your local Flight Standards District Office.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2008-0211, dated December 4, 2008; and Airbus Mandatory
Service Bulletin A310-57-2096, dated May 6, 2008, for related
information.

    Issued in Renton, Washington, on August 17, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-20352 Filed 8-24-09; 8:45 am]

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