[Federal Register: May 8, 2008 (Volume 73, Number 90)]
[Proposed Rules]
[Page 26049-26054]
[DOCID:fr08my08-29]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 91, 125, and 135

[Docket No. FAA-2007-29281; Notice No. 08-06]
RIN 2120-AJ09

Removal of Regulations Allowing for Polished Frost on Wings of
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA is proposing to remove provisions in its regulations
that allow for operations with ``polished frost'' (i.e., frost polished
to make it smooth) on the wings of airplanes operated under parts 125,
135, and certain airplanes operated under part 91. The rule would
increase safety by not allowing operations with polished frost, which
the FAA has determined increases the risk of unsafe flight.

DATES: Send your comments on or before August 6, 2008.

ADDRESSES: You may send comments identified by docket number FAA-2007-
29281 using any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Room W12-
140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Bring comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    For more information on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of this document.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the electronic form of all comments received into any of
our dockets, including the name of the individual sending the comment
(or signing the comment for an association, business,

labor union, etc.). You may review DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000 (65 FR 19477-78),
or you may visit http://DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time and follow the online
instructions for accessing the docket. Or, go to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this proposed rule contact Mike Frank, AFS-260, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone<PHONE_NUMBER> ; facsimile<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>    For legal questions concerning this proposed rule contact Bruce
Glendening, Operations Law Branch--AGC-220, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Later in this preamble under the Additional
Information section, we discuss how you can comment on this proposal
and how we will handle your comments. Included in this discussion is
related information about the docket, privacy, and handling of
proprietary or confidential business information. We also discuss how
you can get a copy of this proposal and related rulemaking documents.

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator, including the authority to
issue, rescind, and revise regulations. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Chapter 447--Safety Regulation. Under section
44701 (a)(5), the FAA is charged with promoting safe flight of civil
aircraft by, among other things, prescribing regulations the FAA finds
necessary for safety in air commerce.

I. Background

    Currently, 14 CFR 91.527 (a), 125.221 (a), and 135.227 (a) allow
pilots to take off with frost adhering to wings or stabilizing or
control surfaces if that frost has been polished to make it smooth.
This frost is referred to as ``polished frost.'' This procedure first
appeared in the Federal Register as Civil Air Regulation Draft Release
No. 60-13, a proposed revision of part 47 of the Civil Air Regulations,
on August 6, 1960.
    Since 1960, the FAA and others have accumulated an extensive amount
of data that would indicate that any amount of contaminants on wings or
critical surfaces could be detrimental to the flight characteristics of
an aircraft. In Advisory Circular (AC) 135-17, the FAA recommends that
all wing frost be removed prior to takeoff, and states that if an
operator desires to polish the frost, the aircraft manufacturer's
recommended procedures should be followed (http://rgl.faa.gov/
Regulatory--and--Guidance--Library/rgAdvisoryCircular.nsf/
MainFrame?OpenFrameSet). No current aircraft manufacturer, however, has
issued any recommended procedures for (1) polishing frost, or (2)
conducting operations with polished frost. In addition, the FAA has no
data to support practical guidance on determining how to polish frost
on a surface to make it acceptably smooth, other than completely
removing the frost and returning the airplane's critical lifting
surfaces to uncontaminated smoothness. Moreover, the term ``polished
frost'' is ambiguous since no standard of acceptable smoothness is
provided. Also, means to ensure that the ``polished frost'' surface
smoothness is equivalent to that of the uncontaminated airplane surface
is operationally impractical. Subsequently, the FAA issued two Safety
Alerts for Operators (SAFOs)--06002 and 06014-- advising against the
practice of polishing frost (http://www.faa.gov/other--visit/aviation--
industry/airline--operators/airline--safety/safo/).
    In addition, there are at least 11 known accidents in which
individuals attempted to ``smooth'' or polish frost, but the aircraft
failed to generate enough lift and crashed shortly after takeoff.\1\
There have been a number of other takeoff accidents and fatalities that
have occurred when flightcrews have consciously decided to take off
without removing frost from the wings of their aircraft. Following the
January 4, 2002 accident at Birmingham, England, the United Kingdom
Aircraft Accident Investigation Board recommended in its Safety
Recommendation 2003-54 that the FAA, and all Authorities who follow FAA
practice, delete all reference to `Polished Frost' within their
regulations and ensure that the term is expunged from Operations
Manuals. In addition, the U.S. National Transportation Safety Board
(NTSB) has issued numerous safety alerts urging operators to ensure
that critical surfaces are free of all contamination prior to take off.
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    \1\ Nine of the 11 accidents would not have been prevented by
this proposed rule, since the aircraft were involved in non-part 91
subpart F operations. Nevertheless, the FAA believes they illustrate
the risk involved in flying with polished frost.
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II. General Discussion of the Proposals

    As previously mentioned, numerous FAA ACs and Safety Alerts have
been issued since 1960 clearly pointing out the hazards of attempting
to take off with any frost on aircraft wings or control surfaces,
polished or not. Adverse aerodynamic effects for lifting surfaces begin
as soon as frost begins to adhere to the surfaces. Determining either
when sufficient polishing achieves a smooth surface or the smoothness
of the contaminated surface without instrumentation is impracticable.
The sheen of polished frost and its tactile smoothness can be
misleading. In addition, the FAA believes achieving uniform smoothness
on all lifting and control surfaces or even symmetrical smoothness in
an operational environment is impossible to determine.
    Technical literature well documents the adverse aerodynamic effects
of surface roughness, such as frost and other ice that adhere to
aircraft surfaces. The literature indicates that surface roughness
formed by frost and adhering ice can result in significant adverse
aerodynamic effects for lifting surfaces, such as wings and flight
control surfaces. For example, (1) a contaminated wing's maximum lift
may be reduced by 30 percent or more; (2) the angle of attack for
maximum lift may be reduced by several degrees; (3) drag may be
increased significantly; and (4) the airplane's handling qualities and
performance may change unexpectedly from that of the uncontaminated
aircraft. The severity of these adverse aerodynamic effects varies
significantly (1) with the magnitude (height and density) and location
of the surface roughness, and (2) with the location of the roughness
relative to the surface leading edge where significant variations may
occur in the local airspeed and surface air loads. Therefore, the FAA
has determined that complete removal of frost from critical surfaces to
achieve uncontaminated surface smoothness is necessary to ensure
acceptable airplane airworthiness. If all wing surfaces, other than
those under the wing in the area of

the fuel tank \2\, and control surfaces are not uniformly smooth upon
take off, the FAA believes an unsafe condition exists.
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    \2\ Takeoffs may be made with frost under the wing area of the
fuel tanks if authorized by the FAA. (See e.g., 14 CFR 125.221
(a)(2) and 135.227 (a)(2).)
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    The FAA is proposing to amend Sec. Sec.  91.527 (a)(3), 125.221
(a), and 135.227 (a) to remove language permitting pilots to take off
with ``polished frost'' adhering to the wings or stabilizing or control
surfaces.
    Within part 91 subpart F, the current text of Sec.  91.527 (a)
states that no pilot may take off an airplane that has-- (1) frost,
snow, or ice adhering to any propeller, windshield, or powerplant
installation or to an airspeed, altimeter, rate of climb, or flight
attitude instrument system; (2) snow or ice adhering to the wings or
stabilizing or control surfaces; or (3) any frost adhering to the wings
or stabilizing or control surfaces, unless that frost has been polished
to make it smooth. The FAA would amend the paragraph to remove the
words ``unless that frost has been polished to make it smooth.''
    Part 91 subpart F provides for the operation of large and turbine-
powered multiengine airplanes and all fractional ownership program
aircraft (regardless of category, class, weight, powerplant or number
of engines). Therefore, the revised provisions in subpart F in this
NPRM would affect the operation of all fractional ownership program
aircraft under subpart K, regardless of whether the aircraft is large
or small and regardless of whether the aircraft is single or multi-
engine.
    Similarly, current Sec. Sec.  125.221 (a) and 135.227 (a) provide
that no pilot may take off an airplane that has frost, ice, or snow
adhering to any propeller, windshield, wing, stabilizing or control
surface, to a powerplant installation, or to an airspeed, altimeter,
rate of climb, or flight attitude instrument system, except that
takeoffs may be made with frost adhering to the wings, or stabilizing
or control surfaces, if the frost has been polished to make it smooth.
The FAA would amend those sections to delete the words ``except * * *
[t]akeoffs may be made with frost adhering to the wings, or stabilizing
or control surfaces, if the frost has been polished to make it
smooth.'' These rule changes may also result in changes to an
operator's operations specifications (OpSpecs) as they relate to ground
deicing operations.
    In addition, the FAA is responding to a recommendation from the
Part 125/135 Aviation Rulemaking Committee, established on April 8,
2003, which provided recommendations to the FAA regarding the safety
and applicability of standards of parts 125, 135, and associated
regulations. In this proposed rule, the FAA is therefore taking the
opportunity to correct the structure of Sec. Sec.  91.527(b),
125.221(c), and 135.227(c). Currently, in each of those paragraphs the
phrase beginning with the words ``unless the aircraft has * * *''
appears to apply only to paragraph (2); however, that clause applies to
all of the provisions of the paragraph. In 1995, the FAA issued a legal
interpretation (included in the docket for this rulemaking action) to
clarify that this language applies to both IFR flight into known or
forecast light or moderate icing conditions and VFR flight into known
light or moderate icing conditions. The FAA is therefore proposing to
re-structure those paragraphs accordingly.

III. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. We have determined that there
is no new information collection requirement associated with this
proposed rule.

IV. International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these proposed regulations.

V. Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment, and Unfunded Mandates Assessment

V.1. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this proposed rule. We suggest readers seeking
greater detail read the full regulatory evaluation, a copy of which we
have placed in the docket for this rulemaking.
    In conducting these analyses, FAA has determined that this proposed
rule: (1) Has benefits that justify its costs, (2) is not an
economically ``significant regulatory action'' as defined in section
3(f) of Executive Order 12866, (3) is not ``significant'' as defined in
DOT's Regulatory Policies and Procedures; (4) would not have a
significant economic impact on a substantial number of small entities;
(5) would not create unnecessary obstacles to the foreign commerce of
the United States; and (6) would not impose an unfunded mandate on
state, local, or tribal governments, or on the private sector by
exceeding the threshold identified above. These analyses are summarized
below.
    Operators and pilots would have at least four alternatives to
choose from to deal with frost that may have accumulated on the wings
of their aircraft. These include: using wing covers, waiting for the
frost to melt, storing the aircraft in a heated hangar, or deicing the
wing surface. The FAA believes that wing covers are the lowest-cost
alternative. Assuming operators impacted by this proposed rule choose
to use wing covers, they would incur total costs of roughly $164,000
($130,000 discounted) over the ten year period from 2009 to 2018. Of
these, $155,000 ($123,000 discounted) would accrue to operators in
Alaska, and $9,500 ($7,500 discounted) would accrue to mainland U.S.
operators. Benefits total roughly $460,000 ($320,000 discounted). About
$433,000 ($301,000 discounted) in benefits would accrue in Alaska,
while the remaining $27,000 ($19,000 discounted) would accrue in the
mainland U.S. These benefits are attributed to averted accidents,
injuries, and aircraft damage. Since benefits exceed costs for both

Alaska and the mainland U.S., the FAA concludes the proposed rule is
cost beneficial. The FAA calls for comments on this determination and
requests that all comments be accompanied by clear and detailed
supporting economic documentation.

V.2. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    This proposed rule would improve aviation safety by removing
references to the ``polished frost'' technique found in 14 CFR
91.527(a), 125.221(a), and 135.227(a). At this time there is no part 91
operator that has an authorized deicing program that incorporates the
polished frost procedure; therefore, this rulemaking only affects on-
demand and commuter services operating under parts 125 and 135. There
are 57 operators operating 188 aircraft that would be affected by the
rule. Based on the SBA size standard defining a small unscheduled air
carrier as one having 1,500 employees or less per company, all of these
operators are considered small entities. As a result, the Regulatory
Flexibility Act applies.
    The FAA assumes that most operators would choose to buy and use
wing covers to comply with the proposed rule. The other alternatives
(waiting for the frost to melt, storing the aircraft in a heated
hangar, or deicing the aircraft) are more expensive than using wing
covers. The FAA estimates that operators would choose to buy wing
covers at an initial cost of $400, plus minimal additional fuel costs
and, if needed, an additional cost of $400 after five years to replace
a worn wing cover.
    In Alaska, there are 21 operators with one aircraft apiece, and 30
operators operating the remaining 156 aircraft. In the mainland U.S.,
there are six operators operating 11 aircraft. The smallest operators
operate only one plane, and would incur a cost of approximately $99 per
year as a result of this rulemaking, a cost that the FAA does not
consider significant. The operator that would be most impacted by the
rule operates 16 affected aircraft, and would incur costs of
approximately $1,584 per year as a result of this rulemaking. This
operator has annual revenues of $5 million. The cost of this rulemaking
represents 0.03 percent of the gross revenues of that operator, and the
FAA does not consider that amount significant. As a result, the FAA
certifies that this proposed rule would not have a significant economic
impact on a substantial number of small entities. The FAA requests
comments from affected entities on this finding and determination.

V.3. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Legitimate domestic objectives, such as safety, are
not considered unnecessary obstacles. The statute also requires
consideration of international standards and, where appropriate, that
they be the basis for U.S. standards. The FAA has assessed the
potential effect of this proposed rule and has determined that it would
have only a domestic impact and would not affect international trade.

V.4. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(adjusted annually for inflation with the base year 1995) in any one
year by State, local, and tribal governments, in the aggregate, or by
the private sector; such a mandate is deemed to be a ``significant
regulatory action.'' The FAA currently uses an inflation-adjusted value
of $136.1 million in lieu of $100 million. This proposed rule does not
contain such a mandate.

VI. Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action 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, and, therefore, would not have federalism implications.

VII. Regulations Affecting Intrastate Aviation in Alaska

    Section 40113(f) of 49 U.S.C. requires the Administrator, when
modifying regulations in title 14 of the CFR in a manner affecting
intrastate aviation in Alaska, to consider the extent to which Alaska
is not served by transportation modes other than aviation, and to
establish appropriate regulatory distinctions. Because the majority of
potentially affected operators are in Alaska, this proposed rule could,
if adopted, affect intrastate aviation in Alaska. The FAA believes,
however, that over 60% of aircraft currently operating in Alaska do not
rely on this procedure. For the remainder of affected operators, the
cost of compliance would be minimal. The FAA, therefore, specifically
requests comments on whether there is justification for applying the
proposed rule differently in intrastate operations in Alaska.

VIII. Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this proposed rulemaking action qualifies for the
categorical exclusion identified in paragraph 312 and involves no
extraordinary circumstances.

IX. Regulations That Significantly Affect Energy Supply, Distribution,
or Use

    The FAA has analyzed this NPRM under Executive Order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a

``significant energy action'' under the executive order because it is
not a ``significant regulatory action'' under Executive Order 12866,
and it is not likely to have a significant adverse effect on the
supply, distribution, or use of energy.

X. Additional Information

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. We also
invite comments relating to the economic, environmental, energy, or
federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, please send only one copy of written comments, or
if you are filing comments electronically, please submit your comments
only one time.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://
www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://
www.faa.gov/regulations--policies/; or
    3. Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Be
sure to identify the docket number, notice number, or amendment number
of this rulemaking.
    You may access all documents the FAA considered in developing this
proposed rule, including economic analyses and technical reports, from
the Internet through the Federal eRulemaking Portal referenced in
paragraph (1).

List of Subjects

14 CFR Part 91

    Aircraft, Airmen, Airports, Aviation safety, Freight.

14 CFR Part 125

    Aircraft, Airmen, Aviation safety.

14 CFR Part 135

    Air taxis, Aircraft, Airmen, Aviation safety.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend chapter I of title 14, Code of Federal
Regulations, as follows:

PART 91--GENERAL OPERATING AND FLIGHT RULES

    1. The authority citation for part 91 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 1155, 40103, 40113, 40120, 44101,
44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717,
44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-
47531, articles 12 and 29 of the Convention on International Civil
Aviation (61 Stat. 1180).

    2. Amend Sec.  91.527 by revising paragraphs (a) and (b) to read as
follows:

Sec.  91.527  Operating in icing conditions.

    (a) No pilot may take off an airplane that has frost, ice, or snow
adhering to any propeller, windshield, stabilizing or control surface;
to a powerplant installation; or to an airspeed, altimeter, rate of
climb, or flight attitude instrument system or wing, except that
takeoffs may be made with frost under the wing in the area of the fuel
tanks if authorized by the FAA.
    (b) No pilot may fly under IFR into known or forecast light or
moderate icing conditions, or under VFR into known light or moderate
icing conditions, unless--
    (1) The aircraft has functioning deicing or anti-icing equipment
protecting each rotor blade, propeller, windshield, wing, stabilizing
or control surface, and each airspeed, altimeter, rate of climb, or
flight attitude instrument system; or
    (2) The airplane has ice protection provisions that meet section 34
of Special Federal Aviation Regulation No. 23; or
    (3) The airplane meets transport category airplane type
certification provisions.
* * * * *

PART 125--CERTIFICATION AND OPERATIONS: AIRPLANES HAVING A SEATING
CAPACITY OF 20 OR MORE PASSENGERS OR A MAXIMUM PAYLOAD CAPACITY OF
6,000 POUNDS OR MORE; AND RULES GOVERNING PERSONS ON BOARD SUCH
AIRCRAFT

    3. The authority citation for part 125 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44705, 44710-
44711, 44713, 44716-44717, 44722.

    4. Amend Sec.  125.221 by revising paragraphs (a) and (c) to read
as follows:

Sec.  125.221  Icing conditions: Operating limitations.

    (a) No pilot may take off an airplane that has frost, ice, or snow
adhering to any propeller, windshield, stabilizing or control surface;
to a powerplant installation; or to an airspeed, altimeter, rate of
climb, flight attitude instrument system, or wing, except that takeoffs
may be made with frost under the wing in the area of the fuel tanks if
authorized by the FAA.
* * * * *
    (c) No pilot may fly under IFR into known or forecast light or
moderate icing conditions, or under VFR into known light or moderate
icing conditions, unless--
    (1) The aircraft has functioning deicing or anti-icing equipment
protecting each rotor blade, propeller, windshield, wing, stabilizing
or control surface, and each airspeed, altimeter, rate of climb, or
flight attitude instrument system; or
    (2) The airplane has ice protection provisions that meet appendix C
of this part; or
    (3) The airplane meets transport category airplane type
certification provisions.
* * * * *

PART 135--OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS
AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT

    5. The authority citation for part 135 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 41706, 40113, 44701-44702, 44705,
44709, 44711-44713, 44715-44717, 44722, 45101-45105.

    6. Amend Sec.  135.227 by revising paragraphs (a) and (c) to read
as follows:

Sec.  135.227  Icing conditions: Operating limitations.

    (a) No pilot may take off an aircraft that has frost, ice, or snow
adhering to any rotor blade, propeller, windshield,

stabilizing or control surface; to a powerplant installation; or to an
airspeed, altimeter, rate of climb, flight attitude instrument system,
or wing, except that takeoffs may be made with frost under the wing in
the area of the fuel tanks if authorized by the FAA.
* * * * *
    (c) No pilot may fly under IFR into known or forecast light or
moderate icing conditions or under VFR into known light or moderate
icing conditions, unless--
    (1) The aircraft has functioning deicing or anti-icing equipment
protecting each rotor blade, propeller, windshield, wing, stabilizing
or control surface, and each airspeed, altimeter, rate of climb, or
flight attitude instrument system; or
    (2) The airplane has ice protection provisions that meet section 34
of appendix A of this part; or
    (3) The airplane meets transport category airplane type
certification provisions.
* * * * *

    Issued in Washington, DC, on May 2, 2008.
John M. Allen,
Acting Director, Flight Standards Service.
 [FR Doc. E8-10246 Filed 5-7-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Rules and Regulations]
[Page 32841-32846]
[DOCID:fr07jn06-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0297; FRL-8061-4]

Fenarimol; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
fenarimol in or on filbert. Interregional Research Project Number 4
(IR-4) requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA). Fenarimol was reassessed and approved by the Agency
effective August 1, 2002. To view the Tolerance Reassessment Progress
and Risk Management Decision (TRED) and related supporting documents,
please refer to docket number (EPA-HQ-OPP-2002-0250-0001) at
http://www.regulations.gov.

DATES: This regulation is effective June 7, 2006. Objections and
requests for hearings must be received on or before August 7, 2006, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0297. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0297 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before August 7, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0297, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 31, 2005 (70 FR 51802) (FRL-7733-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a

pesticide petition (PP 5E4573) by IR-4, 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.421 be
amended by establishing a tolerance for residues of the fungicide
fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-
pyrimidinemethanol] in or on filbert at 0.02 parts per million (ppm).
That notice included a summary of the petition prepared by Gowan
Company, the registrant. There were no comments received in response to
the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 * *
*.''

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of fenarimol on
filbert at 0.02 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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 toxic effects caused by fenarimol 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.epa.gov/EPA-PEST/2002/December/Day-04/p30471.htm
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for fenarimol used for
human risk assessment is shown in Table 1 of this unit:

      Table 1.-- Summary of Toxicological Dose and Endpoints for Fenarimol for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years     NA                       NA                       Rat Developmental and
 ofage)                                                                                Multi-generation
                                                                                Reproductive
                                                                                ToxicityStudy
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NA                       NA                       No appropriate endpoint
 including infants and children)                                                          was available to
                                                                                quantitate risk.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 0.6 mg/kg/day    Special FQPA SF = 3X     Multi-generation
                                       UF = 100 X.............  cPAD = chronic RfD/       Reproduction Study
                                       Chronic RfD = 0.006 mg/   Special FQPA SF =       LOAEL = 1.2 mg/kg/day
                                        kg/day.                  0.002 mg/kg/day.         based on decreased
                                                                                live born litter size
                                                                                in the F1 and F2
                                                                                generations.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral, Dermal,    Dermal/oral study LOAEL  LOC for MOE = 900        Special Reproduction
 andInhalation (1 to 30 days)           = 35 mg/kg/day          (Residential)..........   Study
(Residential)........................                           FQPA factor = 3X UF=     LOAEL = 35 mg/kg/day
                                                                 300.                     based on decreased
                                                                                fertilityand dystocia,
                                                                                an indicator of
                                                                                hormonal effects,
                                                                                observed in aspecial
                                                                                non-guideline cross
                                                                                breeding reproduction/
                                                                                developmentaltoxicity
                                                                                study in rats
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral,     Dermal/oral study NOAEL  LOC for MOE = 100        Multi-generation
 Dermal, and Inhalation (1- 6 months)   = 0.6 mg/kg/day         (Residential)..........   Reproduction Study
(Residential)........................                           FQPA factor = 3X.......   LOAEL = 0.6 mg/kg/day
                                                                                based on decreased
                                                                                live born litter size
                                                                                in the F1 and F2
                                                                                generations
----------------------------------------------------------------------------------------------------------------

Cancer (oral, dermal, inhalation)      NA                       NA                       Fenarimol has been
                                                                                classified as a ``not
                                                                                likely'' human
                                                                                carcinogen (Group E).
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.421)(a)(1) for the residues of fenarimol,
[alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol]
for the following raw agricultural commodities (RACs): Apple at 0.1;
apple, dry pomace at 2.0; apple, wet pomace at 2.0; cattle, fat at 0.1;
cattle, kidney at 0.1; cattle, meat at 0.01; cattle, meat byproducts,
except kidney at 0.05; goat, fat at 0.1; goat, kidney at 0.1; goat,
meat at 0.01; goat, meat byproducts, except kidney at 0.05; horse, fat
at 0.1; horse, kidney at 0.1; horse, meat at 0.01; horse, meat
byproducts, except kidney at 0.05; pear at 0.1; pecan at 0.1; sheep,
fat at 0.1; sheep, kidney at 0.1; sheep, meat at 0.01; and sheep, meat
byproducts, except kidney at 0.05.
    Tolerances have also been established (40 CFR 180.421)(a)(2) for
the combined residues of fenarimol [alpha-(2-chlorophenyl)-alpha-(4-
chlorophenyl)-5-pyrimidinemethanol] and its metabolites [alpha-(2-
chlorophenyl)-alpha-(4-chlorophenyl)-1,4-dihydro-5-pyrimidinemethanol
and 5-[(2-chlorophenyl) (4-chlorophenyl)methyl]-3,4-dihydro-4-
pyrimidinol measured as the total of fenarimol and 5-[(2-chlorophenyl)-
(4-chlorophenyl)methyl]pyrimidine (calculated as fenarimol) for the
following RACs: Banana (import) at 0.5; cherry at 1.0; grape, juice at
0.6; grape pomace (wet and dry) at 2.0; grape at 0.2; grape, raisin,
waste at 3.0; grape, raisin at 0.6. Risk assessments were conducted by
EPA to assess dietary exposures from fenarimol in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for fenarimol, therefore a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. The chronic dietary exposure assessment for
fenarimol is highly refined using anticipated residues based on 1996-
1999 Food and Drug Administration (FDA) monitoring data for apples,
bananas, cherries, grapes and pears. Field trial residue data were used
for pecans and filberts. Percent crop treated (%CT) information and
processing factors, where available, were used in the assessment. There
were no PDP monitoring data available for fenarimol.
    iii. Anticipated residue and percent crop treated (PCT)
information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use
available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide chemicals
that have been measured in food. If EPA relies on such information, EPA
must pursuant to section 408(f)(1) require that data be provided 5
years after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. For the
present action, EPA will issue such Data Call-Ins for information
relating to anticipated residues as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data
Call-Ins will be required to be submitted no later than 5 years from
the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    The Agency used PCT information as follows:
    Almonds 0.1%; apples 25%; bananas < 1%; cherries, sweet 13%;
cherries, tart 9%; grapes, raisin 21%; grapes, table 8%; grapes wine
9%; hazelnuts 9%; pecans 1%; and pears 10%. These PCT figures were
derived from a quantitative usage analysis (QUA) for fenarimol by the
Agency based on data years 1990-1999. The weighted average of percent
crop treated (%CT) was used for estimating chronic dietary exposure.
Additional information on imported bananas was obtained indicating that
less than 1% of bananas consumed in the United States are treated with
fenarimol. For pecans, a default 1% crop treated was assumed (0% CT
reported in QUA).
    The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. The Agency is reasonably certain that the percentage of
the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which fenarimol may
be applied in a particular area.

    iv. Cancer. Fenarimol has been classified as a ``not likely'' human
carcinogen (Group E) and thus a quantitative exposure assessment as to
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenarimol in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fenarimol.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Groundwater models, the estimated
environmental concentrations (EECs) of fenarimol chronic exposures are
estimated to be 26 ppb for surface water and 16 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Fenarimol is not registered for use on any sites that would result
in exposure in or around the home. Fenarimol is registered for use on
turf however,. Applications to turf are limited to golf courses, and
stadium fields or professional athletic fields only. Therefore, the
Agency has determined that the only potential non-occupational
postapplication exposure is short-term dermal exposure to adult
golfers.
    EPA's ``Standard Operating Procedures (SOPs) for Residential
Exposure Assessments'' at (http://www.epa.gov/fedrgstr/EPA-PEST/1999/January/Day-04/o-p34736.htm
) were used to estimate the exposures of

adult golfers contacting treated turf. The SOPs for turf use transfer
coefficients based on mowing studies. Chemical specific data from a
turf transferable residue (TTR) study were available; however, these
TTR data were unacceptable for use in postapplication exposure
assessment. Therefore, default assumptions from the SOPs were used.
Exposures were estimated for short-term dermal contact with treated
turf during the low contact activity of golfing. The exposure estimates
generated for the golfing turf use is based on some upper-percentile
assumptions (i.e., duration of exposure and maximum application rate
for this short-term assessment) and is considered to be representative
of high end exposures. The uncertainties associated with this
assessment stem from the use of an assumed amount of pesticide retained
on turf, and assumptions regarding the transfer of fenarimol residues.
The turf risk estimate is believed to be a reasonable and protective
estimate. Therefore, the level of confidence is fairly high, and does
not under estimate risk.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fenarimol and any other
substances and fenarimol does not appear to produce a toxic metabolite
produced by other substances. EPA has also evaluated comments submitted
that suggested there might be a common mechanism among fenarimol and
other named pesticides that cause brain effects. EPA concluded that the
evidence did not support a finding of common mechanism for fenarimol
and the named pesticides. For the purposes of this tolerance action,
therefore, EPA has not assumed that fenarimol has 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 the policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The developmental and
reproductive toxicity studies showed no evidence of increased
sensitivity or susceptibility of young rats or rabbits following
prenatal or postnatal exposure to fenarimol. However, the studies
demonstrated that fenarimol is associated with hydronephrosis that is
reversible.
    3. Conclusion. The data base for prenatal developmental and
reproductive toxicity is considered complete. Based upon the RED
completed June 2002, the Agency reduced the FQPA Safety factor from 10X
to 3X. It was determined that the 3X would be retained until a special
developmental toxicity study was received and reviewed to confirm if
the potential hormonal effects elicited by inhibition of aromatase
would result in effects in the rat pups. However more recently,
fenarimol has been evaluated in studies considered in EPA's Endocrine
Disruptor Screening Program including the Pubertal Female and
Uterotrophic Assays. The Pubertal Female Assay involves the use of rats
to screen for estrogenic and thyroid activity in females during sexual
maturation, and examines abnormalities associated with sex organs and
puberty markers, as well as thyroid tissue. The Uterotrophic assay
involves the use of female rats to screen for estrogenic effects. In
this in vivo assay, uterine weight changes are measured in
ovariectomised or immature female rats.
    No adverse effects were found in the female pubertal assay when SD
rats were treated at 50 and 250 milligram/kilogram (mg/kg) day for 21
days, except for a decrease in T4 and an increase in circulating TSH
levels. In the Uterotrophic assay, a dose of 200 mg/kg day results in a
significant increase of uterine weights which were accompanied by an
increase in serum FSH levels and a decrease in serum T3 levels. The
uterotrophic response and the effects found on thyroid hormone levels
are found at much higher doses than the regulatory endpoints based on
the rat multi-generation study where fenarimol reduced fertility of
males at 1.2 mg/kg per day with a NOAEL of 0.6 mg/kg per day. The 0.6
mg/kg NOAEL

is over 300-fold lower than the uterotrophic response found in rats at
200 mg/kg.
    In conclusion, there is greater confidence in the current NOAEL of
0.6 mg/kg per day given these recent studies on the reproductive,
developmental and endocrine effects of fenarimol. It is therefore
recommended that the 3X FQPA safety factor be removed because there are
adequate data evaluating the potential endocrine effects of fenarimol
during development and in the young animal. As a result, the Agency no
longer requires a special developmental study.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No acute risk is expected from exposure to fenarimol
since no acute endpoints were identified for the general U.S.
population (including infants and children) or the females 13-50 years
old population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to fenarimol
from food will utilize < 1% of the cPAD for the U.S. population, < 1% of
the cPAD for all infants < 1 year old, and < 1% of the cPAD for children
1-6 years old. There are no residential uses for fenarimol that result
in chronic residential exposure to fenarimol. In addition, there is
potential for chronic dietary exposure to fenarimol in drinking water.
After calculating Drinking Water Level of Comparison (DWLOCs) and
comparing them to the EECs for surface water and ground water, infants
and children, the most sensitive population subgroups slightly exceed
the chronic DWLOC of 20. However, the chronic EECs were estimated using
Tier I modeling and only slightly exceed the DWLOC. Additional data are
being required that will provide important information on the mobility
of fenarimol and its degradates. These studies will help to refine the
chronic surface and ground water drinking water risk assessments.
    The EECs are based on a Tier 1 model FIRST for a turf use scenario
with maximum application rates. The estimated EEC for surface water is
a very conservative estimate. It represents the 1-in-10 year mean
yearly surface water concentration. The Agency's surface water modeling
for drinking water uses a default percent cropped area factor (PCA) for
turf, which represents the fraction of the watershed that is cropped
and treated with the pesticide being modeled. In the absence of a crop-
specific PCA factor, a default PCA of 0.87 is used. The 0.87 factor
represents the maximum fraction of a watershed in the US that is
agriculturally cropped. This default PCA was used for fenarimol
modeling on turf. The Agency is currently attempting to develop PCA
factors specific for turf scenarios, and recognizes that it is unlikely
that 87% of a watershed used for drinking water would be grown to turf
and treated with fenarimol at the maximum rate allowed only for turf
applications especially since applications to turf are limited to golf
courses, and stadium fields or professional athletic fields only.
    The default PCA factor assumed and used in fenarimol modeling is
most likely overestimated and adds to the conservatism of the
assessment. Given the relatively low usage of fenarimol across the
country it is highly unlikely that the amount applied to the watershed
in the model will be concentrated in any real watershed used to derive
drinking water. Therefore, the EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit.
The results indicated in the table below are based upon the RED, and
are considered over estimates. Therefore, the risk estimates shown
below are actually lower than what the table reports.

               Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fenarimol
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population/Subgroup                cPAD/mg/kg/     %/cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.002          < 1%           26           16           70
----------------------------------------------------------------------------------------------------------------
All Infants < 1 year old                                0.002          < 1%           26           16           20
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               0.002          < 1%           26           16           20
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Fenarimol is currently
registered for use that could result in short-term residential exposure
and the Agency has determined that it is appropriate to aggregate
chronic food and water and short-term exposures for fenarimol. Using
the exposure assumptions described in this unit for short-term
exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOE of 1,400 for adult golfers. This
aggregate MOE does not exceed the Agency's level of concern for
aggregate exposure to food and residential uses.
    4. Aggregate cancer risk for U.S. population. Fenarimol has been
classified as a ``not likely'' human carcinogen (Group E).
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to fenarimol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for data collection and enforcement
of tolerances for residues of fenarimol per se in/on plants and
livestock. Adequate methods are also available for determination of
residues of fenarimol and Metabolites B and C in plants Pesticide
Analytical Manual (PAM) Volume II, Methods I (AM-AA-CA-R039-AB-755), II
(AM-AA-CA-R072-AA-755), and III (AM-AA-CA-R124-AA-755.

B. International Residue Limits

    There is no CODEX maximum residue limit for filbert.

V. Conclusion

    Therefore, the tolerance is established for residues of fenarimol,
[alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol],
in or on filbert at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive

Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: May 22, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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

0
2. Section 180.421 is amended by alphabetically adding a commodity to
the table in paragraph (a)(1) to read as follows:

Sec.  180.421  Fenarimol; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Filbert....................................................         0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-8659 Filed 6-6-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: October 19, 2006 (Volume 71, Number 202)]
[Notices]
[Page 61752-61753]
[DOCID:fr19oc06-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-1221-000, ER06-1221-001 and ER06-1221-002]

Parkview AMC Energy, LLC; Notice of Issuance of Order

October 13, 2006.
    Parkview AMC Energy, LLC (Parkview) filed an application for
market-based rate authority, with an accompanying tariff. The proposed
market-based rate tariff provides for the sale of energy, capacity and
ancillary services at market-based rates. Parkview also requested
waivers of various Commission regulations. In particular, Parkview
requested that the Commission grant blanket approval under 18 CFR Part
34 of all future issuances of securities and assumptions of liability
by Parkview.
    On September 7, 2006, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development--West, granted the
requests for blanket approval under Part 34. The Director's order also
stated that the Commission would publish a separate notice in the
Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard or to protest
the blanket approvals of issuances of securities or assumptions of
liability by Parkview should file a motion to intervene or protest with
the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214
(2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is November 13, 2006.
    Absent a request to be heard in opposition by the deadline above,
Parkview is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
Parkview, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Parkview's issuance of securities or assumptions
of liability.

    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-17481 Filed 10-18-06; 8:45 am]

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[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3731]
[DOCID:fr22ja08-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0241]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Institutional Review Boards

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Institutional Review Boards'' has
been approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2007
(72 FR 57948), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0130.
The approval expires on December 31, 2010. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 14, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1005 Filed 1-18-08; 8:45 am]

BILLING CODE 4160-01-S