[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Rules and Regulations]
[Pages 67629-67636]
[FR Doc No: 2023-21631]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0190; Project Identifier 2019-CE-048-AD; Amendment
39-22556; AD 2023-19-06]
RIN 2120-AA64

Airworthiness Directives; Viking Air Limited (Type Certificate
Previously Held by Bombardier Inc. and de Havilland Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 64-09-03,
which applied to all de Havilland (type certificate now held by Viking
Air Limited (Viking)) Model DHC-2 ``Beaver'' airplanes. AD 64-09-03
required inspecting the aileron mass balance weight arms for cracks and
corrosion and replacing any damaged part. Since the FAA issued AD 64-
09-03, Transport Canada superseded its mandatory continuing
airworthiness information (MCAI) to correct an unsafe condition on
these products. This AD requires incorporating into the existing
maintenance records for your airplane the actions and associated
thresholds and intervals, including life limits, specified in a
supplemental inspection and corrosion control manual for Model DHC-2
airplanes. This AD also requires completing all of the initial tasks
identified in this manual and reporting certain corrosion findings to
Viking. The actions in this supplemental inspection and corrosion
control manual include the inspection of the aileron balance weight
arms required by AD 64-09-03. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective November 6, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 6,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0190; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the MCAI, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room

W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact Viking Air Limited Technical Support, 1959 de Havilland Way,
Sidney, British Columbia, Canada V8L 5V5; phone:<PHONE_NUMBER>; fax:
(250) 656-0673; email: [email protected]; website:
vikingair.com/support/service-bulletins.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: James Delisio, Continued Operational
Safety Program Manager, FAA, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to supersede
AD 64-09-03, Amendment 718 (29 FR 5390, April 22, 1964) (AD 64-09-03).
AD 64-09-03 applied to all de Havilland (type certificate now held by
Viking Air Limited) Model DHC-2 ``Beaver'' airplanes. AD 64-09-03
required repetitively inspecting the aileron mass balance weight arms
for cracks and corrosion and replacing any damaged part. AD 64-09-03
resulted from cracks and corrosion found on aileron mass balance weight
arm part numbers (P/Ns) C2WA151, C2WA152, C2WA127, and C2WA128. The FAA
issued AD 64-09-03 to address corrosion-related degradation of the
aileron mass balance weight arms which, if not addressed, could lead to
structural failure with consequent loss of control of the airplane.
    The NPRM published in the Federal Register on February 8, 2022 (87
FR 7065); corrected February 18, 2022 (87 FR 9274). The NPRM was
prompted by AD CF-2019-25, dated July 19, 2019 (referred to after this
as the MCAI), issued by Transport Canada, which is the aviation
authority for Canada. The MCAI states that it supersedes prior
Transport Canada ADs related to a supplementary inspection and
corrosion control program for aging airplanes, which identifies
specific locations of an airplane that must be inspected to ensure
corrosion-related degradation does not result in an unsafe condition.
The MCAI continues to require the tasks included in the initial issue
of Viking, DHC-2 Beaver Supplemental Inspection and Corrosion Control
Manual, PSM 1-2-5, dated June 21, 2017, and requires additional
inspections for components of airframe systems other than flight
controls, which are included in Viking DHC-2 Beaver Supplemental
Inspection and Corrosion Control Manual, PSM 1-2-5, Revision 1, dated
January 10, 2019 (Viking PSM 1-2-5, Revision 1). Corrosion-related
degradation, if not addressed, could lead to structural failure with
consequent loss of control of the airplane.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-0190.
    In the NPRM, the FAA proposed to require establishing a corrosion
prevention and control program approved by the FAA. In the NPRM, the
FAA also proposed to require completing all of the initial tasks
identified in the program and reporting corrosion findings to Viking.
    The FAA issued a supplemental notice of proposed rulemaking (SNPRM)
to amend 14 CFR part 39 to supersede AD 64-09-03. The SNPRM published
in the Federal Register on April 25, 2023 (88 FR 24927). The SNPRM was
prompted by the FAA's decision to revise the proposed actions specified
in the NPRM and to reopen the comment period to allow the public the
chance to comment on whether the proposed AD would have a significant
economic impact on a substantial number of small entities. In the
SNPRM, the FAA proposed to require incorporating into the existing
maintenance records for your airplane the actions and associated
thresholds and intervals, including life limits, specified in Parts 2
and 3 of Viking PSM 1-2-5, Revision 1, completing all the initial tasks
identified in Viking PSM 1-2-5, Revision 1, and reporting to Viking any
Level 2 or Level 3 corrosion findings. The FAA is issuing this AD to
address the unsafe condition on these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from three individuals. The following
presents the comments received on the SNPRM and the FAA's response to
each comment.

Request To Withdraw NPRM and SNPRM

    One individual commenter requested that the FAA reconsider issuing
the proposed AD and a second individual commenter requested that the
FAA withdraw the proposed rulemaking. The first commenter noted that
during an annual inspection, a licensed Airframe and Powerplant (A&P)
mechanic can determine if an airplane has been properly maintained and
if corrosion is present. This commenter indicated that, by issuing the
proposed AD, the FAA would force many operators and pilots to give up
their airplanes due to exorbitant costs. This commenter stated that
because one or two airplanes were found with extensive corrosion, all
Model DHC-2 airplanes should not be placed in the same category and
that ``the Beaver'' is one of the finest built airplanes and should be
respected as such.
    The second individual commenter stated that the FAA must stop broad
brushing all airplanes of a certain build as the same. The commenter
noted that a Model DHC-2 ``Beaver'' built in 1948 is not the same as
one built in 1967 and that the lifetime use of service and
environmental conditions determine an airplane's risk factors. The
commenter explained that many Beavers have thousands of pages of flight
records spanning over 70 years that allow owners and maintainers to
subjectively evaluate an airplane's condition and operating
environments; therefore, based on the points above, the FAA should
immediately withdraw the proposed rulemaking because it lacks merit.
    The FAA acknowledges the commenters' concerns regarding the impact
this final rule will have on operators and pilots. As noted by the
first commenter, Model DHC-2 airplanes are currently required to
perform annual and 100-hour inspections, including inspections for
corrosion, that are required by the Federal Aviation Regulations. The
FAA does not agree that these current regulations require the same
inspections as those proposed in the SNPRM. The inspections proposed in
the SNPRM are focused on certain areas of the airplane and are more
detailed than those covered in the required annual or 100-hour
inspections. The inspections required by this AD are part of a
supplemental inspection and corrosion prevention program that is
included in Parts 2 and 3 of Viking PSM 1-2-5, Revision 1. These
inspection types and intervals address locations or parts that are not
currently required to be inspected as part of annual or 100-hour
inspections in existing regulations. These new inspections and
intervals are needed to detect and address corrosion, which could lead
to structural failure with consequent loss of control of the airplane.

    The FAA also acknowledges the first commenter's concern regarding
the ``exorbitant cost'' of complying with the requirements of this AD
that could result in operators and pilots having to give up their
airplanes. Under 14 CFR 39.1, issuance of an AD is based on the finding
that an unsafe condition exists or is likely to develop in aircraft of
a particular type design. An aging airplane requires more attention
during maintenance procedures and, at times, more frequent inspections
of structural components to detect damage due to environmental
deterioration, accidental damage, and fatigue. The unsafe condition
addressed in this final rule includes undetected corrosion, which could
lead to structural failure and consequent loss of control of the
airplane. Inspections and repairs are therefore necessary to detect and
correct such corrosion before it leads to structural failure.
    In response to both commenters' statements that all Model DHC-2
airplanes should not be placed in the same category, the FAA has
determined that an unsafe condition exists or is likely to exist or
develop in other products of the same type design. In this case, the
FAA independently reviewed the MCAI and related service information and
determined an unsafe condition exists and an AD is needed to address
that unsafe condition. Further, it is within the FAA's authority and
responsibility to issue ADs to require actions to address unsafe
conditions that are not otherwise being addressed (or are not addressed
adequately) by routine maintenance procedures.
    The FAA has not changed this AD regarding this issue.

Request for Clarification Regarding Conflicting AD Requirements for the
Affected Models

    One individual commenter requested clarification regarding what
operators should do if there are conflicts between the requirements
specified in the SNPRM and the requirements of existing ADs for the
affected airplanes. The commenter noted that AD 2008-11-11, Amendment
39-15533 (73 FR 34611, June 18, 2008) (AD 2008-11-11) specifies a
fluorescent penetrant inspection for cracks in the front spar center
section web of the tailplane, while task C55-10-02 in Viking PSM 1-2-5,
Revision 1, allows using a fluorescent penetrant or an eddy current
inspection, which seems contradictory.
    The FAA acknowledges the commenter's concern. The FAA has reviewed
all potentially related ADs against the proposed requirements in the
SNPRM and determined that other than AD 64-09-03, no other ADs need to
be superseded or rescinded. Any other ADs involving inspections for
corrosion on the affected airplanes require either inspections for
different parts or locations on an airplane or the inspections are not
as in-depth or repetitive; therefore, they do not overlap with the
inspections required by this AD. This includes the requirements of AD
2008-11-11, which requires inspecting a different airplane part than
the part specified in task C55-10-02 of Viking PSM 1-2-5, Revision 1.
    The FAA has not changed this AD regarding this issue.

Request To Revise Requirements Based on Airplane Usage Conditions

    One individual commenter requested that the SNPRM be revised to
provide different requirements based on how an airplane is used. The
commenter suggested that instead of using a broad approach and
including all Model DHC-2 airplanes, the FAA should use a logical
evaluation process and consider the following parameters to determine
if an airplane's airworthiness might be compromised due to corrosion:
operating environment (exposure to saltwater); commercial or private
use; stress on the airframe due to repetitive flights with heavy loads;
total flight hours on the airframe; airplane history (has it been
partially or completely rebuilt); and maintenance history.
    The FAA disagrees with the commenter's request to change the SNPRM
based on different airplane operational usage. There is no current
requirement to track the hours spent flying in different conditions or
types of water. Additionally, operators may not know an airplane's
entire flight or maintenance history. Without this detailed knowledge
of each airplane, it would be impossible for the FAA to develop a
special set of inspections based on airplane usage conditions. However,
operators may submit a proposal for revised requirements by requesting
an alternative method of compliance (AMOC) using the procedures
specified in paragraph (i) of this AD.
    The FAA has not changed this AD regarding this issue.

Request To Revise Costs of Compliance

    One individual commenter requested that the FAA revise the labor
rate in the Costs of Compliance section of the SNPRM. The commenter
noted that the FAA's estimate of $85 per hour is not accurate and that
the current labor rate for an experienced DHC-2/3 airplane mechanic is
greater than $110 per hour, depending on where in the United States the
work is being performed. The commenter also mentioned that public
comments on the NPRM that is related to the SNPRM stated that DHC-2
mechanic rates are $110 to $150 per hour, depending on the geographic
regions where the work is being performed. The commenter added that the
proposed costs do not consider the current shortage of qualified
mechanics able to do the inspections.
    The FAA agrees that the labor rate of $85 per work-hour is dated
but disagrees with the commenter's estimate of $110 to $150 per hour.
The FAA notes that the current wage rate for aviation mechanics as
provided by the Bureau of Labor Statistics, found at www.bls.gov/oes/current/oes493011.htm, after accounting for fringe benefits that are
valued at roughly 50% of the nominal wage, is lower than the estimated
fully burdened labor rate (a labor rate with fringe benefits included)
of $85 per work-hour; therefore, the FAA is unable to justify
increasing the labor rate from $85 per work-hour. The FAA continues to
use the higher $85 per work-hour figure in order to provide a
conservative estimate of the costs.
    Regarding the commenter's statement that the wage rate for DHC-2
mechanics varies geographically, the commenter did not provide any
documentation or references to support this statement. Furthermore,
unless the distribution of DHC-2 airplanes also varies along the same
geography, using an average rate captures the average effect, including
any higher wages; therefore, the FAA has not added a geographical
adjustment into its assessment.
    The FAA acknowledges the commenter's concerns regarding labor
shortages, although this does not affect the cost of this final rule.
    The FAA has not changed this AD regarding this issue.

Conclusion

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA reviewed the relevant data,
considered the comments received, and determined that air safety
requires adopting this AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these products. Except for
minor editorial changes, this AD is adopted as proposed in the SNPRM.

ADs Mandating Airworthiness Limitations (ALS)

    The FAA has previously mandated airworthiness limitations by
issuing ADs that require revising the ALS of the existing maintenance
manual or instructions for continued airworthiness to incorporate new
or revised inspections. This AD, however, requires establishing and
incorporating new inspections into the existing maintenance records
required by 14 CFR 91.417(a)(2) or 135.439(a)(2) for your airplane. The
FAA does not intend this as a substantive change. Requiring
incorporation of the new ALS requirements into the existing maintenance
records, rather than requiring individual repetitive inspections and
replacements, allows operators to record AD compliance once after
updating the existing maintenance records, rather than recording
compliance after every inspection and part replacement.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Viking PSM 1-2-5, Revision 1, which specifies
procedures for inspecting locations of the airplane that are
particularly susceptible to corrosion-related degradation and includes
repetitive inspection intervals, defines the different levels of
corrosion, and provides corrective action if corrosion is found.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Other Related Service Information

    The FAA reviewed Viking DHC-2 Beaver Service Bulletin V2/0011,
Revision NC, dated November 28, 2019. This service information provides
a list of new inspection tasks that have been added to the DHC-2
supplementary inspection and corrosion control program, Viking PSM 1-2-
5, Revision 1.

Impact on Intrastate Aviation in Alaska

    In light of the heavy reliance on aviation for intrastate
transportation in Alaska, the FAA has fully considered the effects of
this final rule (including costs to be borne by affected operators)
from the earliest possible stages of AD development. As previously
stated, 14 CFR part 39 requires operators to correct an unsafe
condition identified on an airplane to ensure operation of that
airplane in an airworthy condition. The FAA has determined that the
need to correct corrosion-related degradation in aging aircraft, which
could lead to structural failure with consequent loss of control of the
airplane, outweighs any impact on aviation in Alaska.

Costs of Compliance

    The FAA estimates that this AD affects 409 airplanes of U.S.
registry. The FAA also estimates that it will take about 1 work-hour
per airplane at a labor rate of $85 per work-hour to revise the
existing maintenance records.
    Based on these figures, the FAA estimates the cost of this AD on
U.S. operators to be $34,765 or $85 per airplane.
    The FAA estimates it will take about 1 work-hour to report any
Level 2 corrosion found during the initial or subsequent inspections or
any Level 3 corrosion found during the initial or subsequent
inspections, for an estimated cost of $85 per airplane.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

Authority for This Rulemaking

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

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980, Public Law 96-354, 94 Stat.
1164 (5 U.S.C. 601-612) (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.
    The FAA published an Initial Regulatory Flexibility Analysis (IRFA)
for this rule to aid the public in commenting on the potential impacts
to small entities. The FAA considered the public comments in developing
the final rule and this Final Regulatory Flexibility Analysis (FRFA). A
FRFA must contain the following:
    (1) A statement of the need for, and objectives of, the rule;
    (2) A statement of the significant issues raised by the public
comments in response to the IRFA, a statement of the assessment of the
agency of such issues, and a statement of any changes made in the
proposed rule as a result of such comments;
    (3) The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration (SBA) in
response to the proposed rule, and a detailed statement of any change
made to the proposed rule in the final rule as a result of the
comments;
    (4) A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available;

    (5) A description of the projected reporting, recordkeeping, and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities which will be subject to the
requirement and the type of professional skills necessary for
preparation of the report or record; and
    (6) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.

1. Need for and Objectives of the Rule

    The NPRM proposed to supersede AD 64-09-03, which applied to all de
Havilland (type certificate now held by Viking) Model DHC-2 ``Beaver''
airplanes, because after the FAA issued AD 64-09-03, Transport Canada
superseded its MCAI to identify specific locations of an airplane that
must be inspected to ensure corrosion-related degradation does not
result in an unsafe condition. This final rule requires incorporating
into the existing maintenance records for your airplane the actions and
associated thresholds and intervals, including life limits, specified
in a supplemental inspection and corrosion control manual for Model
DHC-2 airplanes. This final rule also requires completing all the
initial tasks identified in this manual and reporting certain corrosion
findings to Viking. The actions in this supplemental inspection and
corrosion control manual include the inspection of the aileron balance
weight arms required by AD 64-09-03.

2. Significant Issues Raised in Public Comments

    The FAA received comments related to costs from three individual
commenters. The following presents the significant issues in the
comments received on the SNPRM and the FAA's response to each comment.

Request To Revise Requirements Based on Airplane Usage Conditions

    Two commenters requested that the SNPRM be revised to have
different requirements based on how the airplane is used, including but
not limited to corrosion level, operating environment (e.g., near salt
water), commercial or private use, and airplane history.
    The FAA disagrees with the commenters' requests to change the SNPRM
based on airplane operational usage. There is no current requirement to
track the hours spent flying in different conditions or types of water.
Additionally, operators may not know an airplane's entire flight or
maintenance history. Without this detailed knowledge of each airplane,
it would be impossible for the FAA to develop a special set of
inspections based on airplane usage conditions. However, operators may
submit a proposal for revised requirements by requesting an AMOC using
the procedures specified in paragraph (i) of this AD. The FAA has not
changed this AD regarding this issue.

Request To Revise Costs of Compliance: Labor Rate

    One commenter requested that the FAA revise the labor rate in the
Costs of Compliance section of the SNPRM. The commenter noted that
current labor rates are anywhere from $110 to $150 per hour and added
that the proposed costs do not consider the current shortage of
qualified mechanics able to do the inspections.
    The FAA agrees that the labor rate of $85 per work-hour provided in
the SNPRM is dated but disagrees with the provided estimate of $110 to
$150 per hour provided by the commenter. The FAA notes that the current
wage rate for aviation mechanics as provided by the Bureau of Labor
Statistics, found at www.bls.gov/oes/current/oes493011.htm, after
accounting for fringe benefits that are valued at roughly 50% of the
nominal wage, is lower than the estimated fully burdened labor rate (a
labor rate with fringe benefits included) of $85 per work-hour.
Therefore, the FAA is unable to justify increasing the labor rate from
$85 per work-hour. The FAA continues to use the higher $85 per work-
hour figure in order to provide a conservative estimate of the costs.
    The commenter also indicated that the wage rate for DHC-2 mechanics
varies geographically but did not provide any documentation or
references to support this statement. Furthermore, unless the
distribution of DHC-2 airplanes also varies along the same geography,
using an average rate captures the average effect, including any higher
wages; therefore, the FAA has not added a geographical adjustment into
its assessment.

3. Response to SBA Comments

    The Chief Counsel for Advocacy of the SBA did not file any comments
in response to the SNPRM. Thus, the FAA did not make any changes to
this final rule.

4. Small Entities to Which the Rule Will Apply

    The FAA used the definition of small entities in the RFA for this
analysis. The RFA defines small entities as small businesses, small
governmental jurisdictions, or small organizations. In 5 U.S.C. 601(3),
the RFA defines ``small business'' to have the same meaning as ``small
business concern'' under section 3 of the Small Business Act. The Small
Business Act authorizes the SBA to define ``small business'' by issuing
regulations.
    SBA (2022) has established size standards for various types of
economic activities, or industries, under the North American Industry
Classification System (NAICS).\1\ These size standards generally define
small businesses based on the number of employees or annual receipts.
---------------------------------------------------------------------------

    \1\ Small Business Administration (SBA). 2022. Table of Size
Standards. Effective July 14, 2022. https://www.sba.gov/document/support-table-size-standards.
---------------------------------------------------------------------------

    The FAA Civil Aircraft Registry shows 409 Model DHC-2 Mk. I, DHC-2
Mk. II, and DHC-2 Mk. III airplanes that will be affected by this AD.
These 409 airplanes are registered to 235 private businesses, 76
individuals, and 3 government agencies. The 76 individuals and 3
government agencies are excluded from this analysis as the RFA does not
apply to individuals and the 3 government agencies are not small
entities as defined by the RFA.\2\
---------------------------------------------------------------------------

    \2\ Two airplanes are registered to the U.S. Department of the
Interior. Five airplanes are registered to the United States Forest
Service, within the U.S. Department of Agriculture. Two airplanes
are registered to the State of Alaska to the Alaska Department of
Fish & Game. These government agencies and are not small entities
under the RFA.
---------------------------------------------------------------------------

    Three hundred nineteen (319) airplanes are owned and operated by
235 private entities. A sample of 50 private businesses was randomly
selected for the analysis.\3\ Of the 50 sampled entities, 45 were found
to be small. The results of the cost impact analysis for these 45 small
entities are shown in Table 1 and will be discussed in the following
section.
---------------------------------------------------------------------------

    \3\ The sample was selected by shuffling the order of the list
of 409 DHC-2 airplanes in the FAA Registry and going down the
randomized list. If revenue and employee count data were available,
it was included in the sample; otherwise, it was excluded. This
process was repeated until 50 firms, for which revenue and employee
data were available, had been added to the sample. The shuffling was
accomplished by giving each entry in the registry an index value
between 0 and 1 using Excel's RAND function. The entries were then
sorted by that index value to randomize their order.
---------------------------------------------------------------------------

    As can be seen, the impacts range from nearly 0%, to a maximum of
0.5%. The average impact is 0.1%, and the median impact rounds to 0.0%.
As

such, the FAA has determined that this rule will not significantly
impact a substantial number of small entities.

                                                         Table 1--Cost Impact on Small Entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Cost/
             Operator                FAA Registry type    DHC-2 A/C   Revenues      Cost     revenue     NAICS      Size standard       NAICS industry
                                                                      ($1,000)                 (%)        code
--------------------------------------------------------------------------------------------------------------------------------------------------------
ALASKAS FISHING UNLIMITED INC....  Non-Citizen Corp....           1          79     $170.0        0.2     721214  $8 mn............  Recreational and
                                                                                Vacation Camps
                                                                                (except
                                                                                Campgrounds).
DOUGLAS AVIATION LTD.............  Corporation.........           2          90      340.0        0.4     541990  $17 mn...........  All Other
                                                                                Professional,
                                                                                Scientific and
                                                                                Technical
                                                                                Services.
NORTHSTAR HOLDINGS LLC...........  LLC.................           3         110      510.0        0.5     551112  $40 mn...........  Offices of Other
                                                                                Holding Companies.
RHK OF KANSAS....................  Corporation.........           1         110      170.0        0.2     541110  $13.5 mn.........  Offices of Lawyers.
SUMMIT LEASING LLC...............  LLC.................           1         110      170.0        0.2     532490  $35 mn...........  Other Comm'l & Ind.
                                                                                Machinery and
                                                                                Equip. Rental &
                                                                                Leasing.
JESPERSEN AIRCRAFT SERVICES INC..  Corporation.........           3         113      510.0        0.4     481219  $22 mn...........  Other Nonscheduled
                                                                                Air
                                                                                Transportation.
KATMAI AIR LLC...................  LLC.................           1         117      170.0        0.1     532411  $40 mn...........  Comm'l Air, Rail, &
                                                                                Water Transp.
                                                                                Equip. Rental and
                                                                                Leasing.
MUSTANG HIGH FLIGHT LLC..........  LLC.................           1         127      170.0        0.1     334511  1250 emp.........  Search, Detect.,
                                                                                Nav., Guid.,
                                                                                Aero., & Naut.
                                                                                Systems & Inst.
                                                                                Mfg.
FLIGHT MANAGEMENT LLC............  LLC.................           2         161      340.0        0.2     561110  $11 mn...........  Office
                                                                                Administrative
                                                                                Services.
--------------------------------------------------------------------------------------------------------------------------------------------------------
NEWHALEN LODGE INC...............  Corporation.........           3         165      510.0        0.3     721199  $8 mn............  All Other Traveler
                                                                                Accommodation.
4R AVIATION LLC..................  LLC.................           1         177      170.0        0.1     336411  1500 emp.........  Aircraft
                                                                                Manufacturing.
RAINBOW KING LODGE INC...........  Corporation.........           2         209      340.0        0.2     721199  $8 mn............  All Other Traveler
                                                                                Accommodation.
DOYON AIRCRAFT LEASING LLC.......  LLC.................           1         250      170.0        0.1     532411  $40 mn...........  Comm'l Air, Rail, &
                                                                                Water Transp.
                                                                                Equip. Rental and
                                                                                Leasing.
KENMORE CREW LEASING INC TRUSTEE.  Corporation.........           1         278      170.0        0.1     532490  $35 mn...........  Other Comm'l & Ind.
                                                                                Machinery and
                                                                                Equip. Rental &
                                                                                Leasing.
COMANCHE FIGHTERS LLC............  LLC.................           1         301      170.0        0.1     813930  $14.5 mn.........  Labor Unions and
                                                                                Similar Labor
                                                                                Organizations.
BAY AIR INC......................  Corporation.........           1         307      170.0        0.1     481111  1500 emp.........  Scheduled Passenger
                                                                                Air
                                                                                Transportation.
COYOTE AIR LLC...................  LLC.................           2         310      340.0        0.1     481211  1500 emp.........  Nonscheduled
                                                                                Chartered
                                                                                Passenger Air
                                                                                Transp.
KINGFISHER AIR INC...............  Corporation.........           1         366      170.0        0.0     481219  $22 mn...........  Other Nonscheduled
                                                                                Air
                                                                                Transportation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
ASSOCIATED LEASING LLC...........  LLC.................           1         500      170.0        0.0     532490  $35 mn...........  Other Comm'l & Ind.
                                                                                Machinery and
                                                                                Equip. Rental &
                                                                                Leasing.
TIKCHIK NARROWS LODGE INC........  Corporation.........           3         720      510.0        0.1     721214  $8 mn............  Recreational and
                                                                                Vacation Camps
                                                                                (except
                                                                                Campgrounds).
NORTHWEST SEAPLANES INC..........  Corporation.........           3         750      510.0        0.1     481111  1500 emp.........  Scheduled Passenger
                                                                                Air
                                                                                Transportation.
SNOW MOUNTAIN ENTERPRISES LLC....  LLC.................           1         750      170.0        0.0     532000  $8 mn............  Rental and Leasing
                                                                                Services, N.F.S.
ISLAND WINGS AIR SERVICE LLC.....  LLC.................           2         956      340.0        0.0     481211  1500 emp.........  Nonscheduled
                                                                                Chartered
                                                                                Passenger Air
                                                                                Transp.
TVPX AIRCRAFT SOLUTIONS INC        Corporation.........           3       1,157      510.0        0.0     336310  1000 emp.........  Motor Vehicle
 TRUSTEE.                                                                                Gasoline Engine
                                                                                and Engine Parts
                                                                                Mfg.
SHELDON AIR SERVICE LLC..........  LLC.................           1       1,400      170.0        0.0     481219  $22 mn...........  Other Nonscheduled
                                                                                Air
                                                                                Transportation.
TALKEETNA AIR TAXI INC...........  Corporation.........           1       1,635      170.0        0.0     481219  $22 mn...........  Other Nonscheduled
                                                                                Air
                                                                                Transportation.
NO SEE UM LODGE INC..............  Corporation.........           3       2,036      510.0        0.0     721214  $8 mn............  Recreational and
                                                                                Vacation Camps
                                                                                (except
                                                                                Campgrounds).
--------------------------------------------------------------------------------------------------------------------------------------------------------
WARD AIR INC.....................  Corporation.........           4       2,191      680.0        0.0     481219  $22 mn...........  Other Nonscheduled
                                                                                Air
                                                                                Transportation.
HISTORIC FLIGHT FOUNDATION.......  Corporation.........           1       2,500      340.0        0.0     712110  $30 mn...........  Museums.
LAKE HAVASU SEAPLANES LLC........  LLC.................           1       2,500      170.0        0.0     611000  $8 mn............  Educational
                                                                                Services, N.F.S.
RDJ BROTHERS TRUCKING INC........  Corporation.........           1       2,500      170.0        0.0     236000  $39.5 mn.........  Construction of
                                                                                buildings, N.F.S.
SEAWIND AVIATION INC.............  Corporation.........           2       2,500      170.0        0.0     481211  1500 emp.........  Nonscheduled
                                                                                Chartered
                                                                                Passenger Air
                                                                                Transp.
TIKCHIK AIRVENTURES LLC..........  LLC.................           1       2,500      170.0        0.0     481211  1500 emp.........  Nonscheduled
                                                                                Chartered
                                                                                Passenger Air
                                                                                Transp.
WOLF TRAIL LODGE INC.............  Corporation.........           1       2,500      170.0        0.0     721000  $8 mn............  Accommodation,
                                                                                N.F.S.
ANDREW AIRWAYS INC...............  Corporation.........           3       2,576      510.0        0.0     485999  $16.5 mn.........  All Other Transit
                                                                                and Ground
                                                                                Passenger
                                                                                Transportation.

ALASKAS ENCHANTED LAKE LODGE INC.  Corporation.........           2       2,729      340.0        0.0     721310  $12.5 mn.........  Rooming & Boarding
                                                                                Houses,
                                                                                Dormitories, and
                                                                                Workers' Camps.
--------------------------------------------------------------------------------------------------------------------------------------------------------
RAINBOW RIVER LODGE LLC..........  LLC.................           2       4,000      340.0        0.0     721214  $8 mn............  Recreational and
                                                                                Vacation Camps
                                                                                (except
                                                                                Campgrounds).
K BAY AIR LLC....................  LLC.................           1       4,427      170.0        0.0     481219  $22 mn...........  Other Nonscheduled
                                                                                Air
                                                                                Transportation.
RAPIDS CAMP LODGE INC............  Corporation.........           1       7,000      170.0        0.0     713990  $8 mn............  All Other Amusement
                                                                                and Recreation
                                                                                Industries.
PROGRESSIVE PLASTICS INC.........  Corporation.........           1       7,500      170.0        0.0     326199  750 emp..........  All Other Plastics
                                                                                Product
                                                                                Manufacturing.
BROWN HELICOPTER INC.............  Corporation.........           1       9,000      170.0        0.0     336412  1500 emp.........  Aircraft Engine and
                                                                                Engine Parts
                                                                                Manufacturing.
PERRYCOOK FLIGHT SERVICES LLC....  LLC.................           1      12,500      170.0        0.0     481211  1500 emp.........  Nonscheduled
                                                                                Chartered
                                                                                Passenger Air
                                                                                Transp.
KOMRO INTERNATIONAL LLC..........  LLC.................           1      14,100      170.0        0.0     423820  125 emp..........  Farm & Garden
                                                                                Machinery & Equip.
                                                                                Merchant
                                                                                Wholesalers.
CONCRETE WORKS OF COLORADO INC...  Corporation.........           1      16,190      170.0        0.0     238110  $16.5 mn.........  Poured Concrete
                                                                                Foundation and
                                                                                Structure
                                                                                Contractors.
KENMORE AIR HARBOR LLC...........  LLC.................           9      51,500    1,530.0        0.0     481111  1500 emp.........  Scheduled Passenger
                                                                                Air
                                                                                Transportation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 80 $161,997 $13,600.
Mean $3,600 $302 0.1%
Median $956 $170 0.0%
Notes:
1. The size standard is the maximum size for the NAICS industry considered by the Small Business Administration to be a small entity.
2. AD costs per airplane are 1 work-hour x $85 = $85 + $85 reporting costs for initial inspection, for a total of $170.
3. All percentage figures are rounded to the nearest tenth of a percent. All 0.0% figures represent values below 0.1%, but above 0%.

5. Projected Reporting, Recordkeeping, and Other Compliance
Requirements

    The FAA estimates that this AD will take 1 work-hour per airplane
at a labor rate of $85 per work-hour to incorporate into the existing
maintenance records the actions specified in Parts 2 and 3 of Viking
PSM 1-2-5, Revision 1, plus $85 per airplane to report any Level 2
corrosion found during the initial or subsequent inspections or any
Level 3 corrosion found during the initial or subsequent inspections,
for an estimated total cost of $170 per airplane.
    The estimated cost of this AD, per small entity, is shown in the
``Cost'' column of Table 1 and cost impact is measured by cost as a
percentage of revenues. As the table shows, the mean cost impact is
0.1% of annual revenues,\4\ while the median cost impact is 0.0%.
---------------------------------------------------------------------------

    \4\ These revenue data come from online sources such as
zoominfo.com, opencorporates.com, buzzfile.com, manta.com,
allbiz.com, and lookupcompanyrevenue.com.
---------------------------------------------------------------------------

    To the extent that small entities provide more unique services or
serve markets with less competition, they may also be able to pass on
costs in the form of price increases. However, the FAA assumed that
none of these small entities would be able to pass these compliance
costs to their customers in terms of higher prices. This shows no
significant impact on any of the small entities.

6. Significant Alternatives Considered

    As part of the FRFA, the FAA is required to consider regulatory
alternatives that may be less burdensome.
    The FAA did not find any significant regulatory alternatives to
this AD that would accomplish the safety objectives of this AD.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 64-09-03, Amendment 718 (29 FR
5390, April 22, 1964); and
0
b. Adding the following new airworthiness directive:

2023-19-06 Viking Air Limited (Type Certificate Previously Held by
Bombardier Inc. and de Havilland Inc.): Amendment 39-22556; Docket
No. FAA-2022-0190; Project Identifier 2019-CE-048-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective November 6, 2023.

(b) Affected ADs

    This AD replaces AD 64-09-03, Amendment 718 (29 FR 5390, April
22, 1964).

(c) Applicability

    This AD applies to Viking Air Limited (type certificate
previously held by Bombardier Inc. and de Havilland Inc.) Model DHC-
2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes, all serial
numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2000, Airframe.

(e) Unsafe Condition

    This AD was prompted by 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 corrosion-
related degradation in aging aircraft. The FAA is issuing this AD to
detect and address corrosion, which could lead to structural failure
with consequent loss of control of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 90 days after the effective date of this AD,
incorporate into the existing maintenance records required by 14 CFR
91.417(a)(2) or 135.439(a)(2), as applicable for your airplane, the
actions and associated thresholds and intervals, including life
limits, specified in Parts 2 and 3 of Viking DHC-2 Beaver
Supplemental Inspection and Corrosion Control Manual, PSM 1-2-5,
Revision 1, dated January 10, 2019 (Viking PSM 1-2-5, Revision 1).
Do each initial task within 6 months after the effective date of
this AD or at the threshold for each applicable task specified in
Part 3 of Viking Product Support Manual PSM 1-2-5, Revision 1,
whichever occurs later. Where Viking PSM 1-2-5, Revision 1,
specifies contacting Viking for instructions on forward and rear fin
attachment bolt replacement, inspection, and installation, and for a
disposition regarding attachment bolts, this AD requires contacting
the Manager, International Validation Branch, FAA; or Transport
Canada; or Viking's Transport Canada Design Approval Organization
(DAO). If approved by the DAO, the approval must include the DAO-
authorized signature.

    Note 1 to paragraph (g)(1): Viking DHC-2 Beaver Service Bulletin
V2/0011, Revision NC, dated November 28, 2019, contains additional
information related to this AD.

    (2) After the action required by paragraph (g)(1) of this AD has
been done, no alternative actions and associated thresholds and
intervals, including life limits, are allowed unless they are
approved as specified in paragraph (i) of this AD.

(h) Reporting

    (1) For inspections done after the effective date of this AD,
report to Viking any Level 2 or Level 3 corrosion, as specified in
Viking PSM 1-2-5, Revision 1, at the times specified in and in
accordance with part 3, paragraph 5, of Viking PSM 1-2-5, Revision
1.
    (2) For inspections done before the effective date of this AD,
within 30 days after the effective date of this AD, report to Viking
any Level 2 or Level 3 corrosion, as specified in Viking PSM 1-2-5,
Revision 1, in accordance with part 3, paragraph 5, of Viking PSM 1-
2-5, Revision 1.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, mail
it to ATTN: Program Manager, Continuing Operational Safety, at the
address identified in paragraph (j)(2) of this AD or email to: [email protected]. If mailing information, also submit
information by email.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved specifically for this AD by the Manager,
International Validation Branch, FAA.

(j) Additional Information

    (1) Refer to the MCAI from Transport Canada, AD CF-2019-25,
dated July 5, 2019, for related information. This Transport Canada
AD may be found in the AD docket at regulations.gov under Docket No.
FAA-2022-0190.
    (2) For more information about this AD, contact James Delisio,
Continued Operational Safety Program Manager, FAA, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Viking DHC-2 Beaver Supplemental Inspection and Corrosion
Control Manual, PSM 1-2-5, Revision 1, dated January 10, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney,
British Columbia, Canada, V8L 5V5; phone:<PHONE_NUMBER>; fax: (250)
656-0673; email: [email protected]; website:
vikingair.com/support/service-bulletins.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 15, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-21631 Filed 9-29-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 6, 2008 (Volume 73, Number 110)]
[Notices]
[Page 32338]
[DOCID:fr06jn08-87]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0288]

Compliance Policy Guide Sec. 560.700 Processing of Imported
Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.) (CPG
7119.10); Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of Compliance Policy Guide Sec. 560.700 Processing of
Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.)
(CPG 7119.10) (CPG Sec. 560.700). CPG Sec. 560.700 is included in FDA's
Compliance Policy Guides Manual, which was listed in the Annual
Comprehensive List of Guidance Documents that published on March 28,
2006.

DATES: The withdrawal is effective June 6, 2008.

FOR FURTHER INFORMATION CONTACT: Robert D. Samuels, Center for Food
Safety and Applied Nutrition (HFS-325), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice containing a cumulative list of
guidances available from the agency that published in the Federal
Register on March 28, 2006 (71 FR 15422 at 15453), FDA included the
Compliance Policy Guides Manual, which includes CPG Sec. 560.700. FDA
is withdrawing CPG Sec. 560.700 because it is obsolete.

    Dated: May 15, 2008.
Margaret O' K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E8-12766 Filed 6-5-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: June 16, 2010 (Volume 75, Number 115)]
[Proposed Rules]
[Page 34076-34077]
[DOCID:fr16jn10-34]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 761

[EPA-HQ-OPPT-2009-0757; FRL-8831-8]
RIN 2070-AJ38

Polychlorinated Biphenyls (PCBs); Reassessment of Use
Authorizations; Extension of Comment Period and Additional Public
Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance notice of proposed rulemaking; extension of comment
period and additional public meetings.

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

SUMMARY: EPA issued an advance notice of proposed rulemaking (ANPRM) in
the Federal Register of April 7, 2010, concerning the reassessment of
the use authorizations for PCBs. This document extends the comment
period for 45 days, from July 6, 2010, to August 20, 2010. This
extension is necessary to provide the public with an opportunity to
provide additional and more thorough comments. Also, EPA is holding two
additional public meetings to enable additional public comment on the
ANPRM during the comment period extension.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2009-0757, must be received on or before August 20, 2010.
     Meetings will be held on July 22, 2010, from 9 a.m. until the last
speaker has spoken or until 1 p.m., in San Francisco, CA and on July
29, 2010, from 6 p.m. to 9 p.m., in New York, NY. Requests to
participate in a meeting must be received 10 days prior to the date of
the meeting.
     To request accommodation of a disability, please contact the
technical person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of April 7, 2010, for submission of
comments.
     The July 22, 2010 meeting will held in the Hawaii/Palau Room,
First Floor Conference Room, 75 Hawthorne St., San Francisco, CA 94105
and the July 29, 2010 meeting will be held in the Empire Room at the
Hilton Times Square, 234 West 42\nd\ St., New York, NY 10036. Requests
to participate in the meeting, identified by docket ID number EPA-HQ-
OPPT-2009-0757, may be submitted to the technical person listed under
FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
John H. Smith, National Program Chemicals Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 566-0512; e-mail address<EMAIL_ADDRESS>     For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY

14620; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register of April 7, 2010 (75 FR
17645) (FRL-8811-7). In that document, EPA seeks information about the
use authorizations for PCBs. EPA is hereby extending the comment
period, which was set to end on July 6, 2010, to August 20, 2010.
     The additional meeting in New York, NY will be held in the evening
at the request of New York City parents who would like to attend to
comment on our request for comments on the excluded products
provisions, e.g., caulk, of the current PCB regulations. The additional
meeting in San Francisco, CA will be held to accommodate West Coast
stakeholders. In San Francisco, the meeting attendees will need photo
identification.
    You may submit a request to participate in the public meeting as a
speaker or observer either in person or as an observer only by
teleconference. Do not submit any information in your request to
participate that is considered Confidential Business Information (CBI).
    To access the docket, please follow the detailed instructions as
provided under ADDRESSES in the April 7, 2010 Federal Register
document. If you have questions, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 761

    Environmental protection, Hazardous substances, Labeling,
Polychlorinated biphenyls (PCBs), Reporting and recordkeeping
requirements.

    Dated: June 9, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

[FR Doc. 2010-14522 Filed 6-15-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
[Pages 55268-55272]
[FR Doc No: 2011-22868]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0054; FRL-8887-4]

Chromobacterium subtsugae Strain PRAA4-1\T\; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Chromobacterium subtsugae strain PRAA4-
1\T\ in or on all food commodities when applied as an insecticide or
miticide and used in accordance with good agricultural practices.
Marrone Bio Innovations, Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of
Chromobacterium subtsugae strain PRAA4-1\T\ under the FFDCA.

DATES: This regulation is effective September 7, 2011. Objections and
requests for hearings must be received on or before November 7, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0054. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), 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 code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0054 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 7, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0054, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S.

Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 10, 2010 (75 FR 11171) (FRL-8810-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9F7674) by Marrone Bio Innovations, Inc., 2121 Second
Street, Suite B-107, Davis, CA 95618. The petition requested that 40
CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of Chromobacterium subtsugae
strain PRAA4-1\T\. This notice referenced a summary of the petition
prepared by the petitioner, Marrone Bio Innovations, Inc., which is
available in the docket via http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue * * *'' Additionally, section 408(b)(2)(D) of FFDCA requires
that the EPA consider ``available information concerning the cumulative
effects of [a particular pesticide's] * * * residues and other
substances that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

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

A. Overview of Chromobacterium subtsugae Strain PRAA4-1\T\

    Chromobacterium subtsugae strain PRAA4-1\T\ is a naturally
occurring, gram-negative, violet-pigmented bacterium that was isolated
from soil under an eastern hemlock (Tsuga canadensis) in the Catoctin
Mountain region of central Maryland. The United States Department of
Agriculture found this isolate of Chromobacterium subtsugae to be
orally toxic to Colorado potato beetle (Leptinotarsa decemlineata)
larvae, small hive beetle (Aethina tumida) larvae, southern corn
rootworm (Diabrotica undecimpunctata) larvae and adults, and southern
green stink bug (Nezara viridula) adults. Additional testing has shown
that Chromobacterium subtsugae strain PRAA4-1\T\-treated diet resulted
in reduced feeding in beet armyworm (Spodoptera exigua), cabbage looper
(Trichoplusia ni), tobacco budworm (Heliothis virescens), diamondback
moth (Plutella xylostella), and southern corn rootworm, suggesting this
microbe's insecticidal activity is due to reduction in weight or
inhibition of feeding. In light of the demonstrated insecticidal and
miticidal capabilities of Chromobacterium subtsugae strain PRAA4-1\T\,
Marrone Bio Innovations, Inc. has proposed to register pesticide
products that could be applied to agricultural and greenhouse crops,
including vegetables, fruit, flowers, bedding plants, ornamentals, and
turf, to control certain insect and mite pests.

B. Microbial Pesticide Toxicology Data Requirements

    All mammalian toxicology data requirements supporting the request
for an exemption from the requirement of a tolerance for residues of
Chromobacterium subtsugae strain PRAA4-1\T\ in or on all food
commodities have been fulfilled with data submitted by the petitioner
or data waiver requests that have been granted by EPA. The toxicity
tests (acute oral, dermal, and inhalation toxicity) and irritation
tests (acute eye and primary dermal irritation), which addressed
potential routes of exposure to the active ingredient, were all
classified in Toxicity Category IV (see 40 CFR 156.62). Moreover, an
acute injection toxicity/pathogenicity test indicated that
Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic, infective,
and/or pathogenic via the intravenous route of exposure, a worst-case
scenario whereby the skin is bypassed as a barrier. Finally,
Chromobacterium subtsugae strain PRAA4-1\T\ is not recognized as a
dermal sensitizer, and the petitioner has reported that no
hypersensitivity incidents occurred during development and testing of
this bacterium. The overall conclusions from all toxicological
information submitted by the petitioner are described below, while more
in-depth synopses of the study results can be found in the associated
Biopesticides Registration Action Document provided as a reference in
Unit IX. (Ref. 1).
    1. Acute oral toxicity--rat (Harmonized Guideline 870.1100; Master
Record Identification Number (MRID No.) 479450-03). An acceptable acute
oral toxicity study demonstrated that Chromobacterium subtsugae strain
PRAA4-1\T\ was not toxic to female rats when dosed at 5,000 milligrams
per kilogram (mg/kg). The median lethal dose (LD50) (i.e., a
statistically derived single dose that can be expected to cause death
in 50% of test animals) was greater than 5,000 mg/kg (Toxicity Category
IV).
    2. Acute oral toxicity/pathogenicity (Harmonized Guideline
885.3050; MRID No. 479450-23). Upon consideration of results of other
definitive toxicological data submitted by the petitioner, EPA waived
acute oral toxicity/pathogenicity testing for Chromobacterium subtsugae
strain PRAA4-1\T\. An acute oral toxicity study conducted on rats (MRID
No. 479450-03) demonstrated that Chromobacterium subtsugae strain
PRAA4-1\T\ was not toxic (LD50 greater than 5,000 mg/kg;
Toxicity Category IV), while an acute injection toxicity/pathogenicity
study conducted on rats (MRID No. 479450-11) showed that
Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic, infective,
and/or pathogenic when the skin was bypassed as a barrier. EPA believes
these data, when taken together, clearly

indicate that this bacterium would not be toxic, infective, and/or
pathogenic through the oral route of exposure and that further testing
is not necessary.
    3. Acute inhalation toxicity--rat (Harmonized Guideline 870.1300;
MRID No. 479450-05). An acceptable acute inhalation toxicity study
demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was not
toxic to male and female rats when exposed to 2.12 milligrams per liter
(mg/L). The median lethal concentration (LC50) (i.e., a
statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals) was greater than 2.12 mg/L
(Toxicity Category IV).
    4. Acute pulmonary toxicity/pathogenicity (Harmonized Guideline
885.3150; MRID No. 479450-23). Upon consideration of results of other
definitive toxicological data submitted by the petitioner, EPA waived
acute pulmonary toxicity/pathogenicity testing for Chromobacterium
subtsugae strain PRAA4-1\T\. An acute inhalation toxicity study
conducted on rats (MRID No. 479450-05) demonstrated that
Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic
(LC50 greater than 2.12 mg/L; Toxicity Category IV), while
an acute injection toxicity/pathogenicity study conducted on rats (MRID
No. 479450-11) showed that Chromobacterium subtsugae strain PRAA4-1\T\
was not toxic, infective, and/or pathogenic when the skin was bypassed
as a barrier. EPA believes these data, when taken together, clearly
indicate that this bacterium would not be toxic, infective, and/or
pathogenic through the inhalation route of exposure and that further
testing is not necessary.
    5. Acute injection toxicity/pathogenicity (intravenous)--rat
(Harmonized Guideline 885.3200; MRID No. 479450-11). An acceptable
acute injection toxicity and pathogenicity (intravenous) demonstrated
that Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic,
infective, and/or pathogenic to rats when dosed intravenously at 3.1 x
10 \6\ colony-forming units per animal.
    6. Acute dermal toxicity--rat (Harmonized Guideline 870.1200; MRID
No. 479450-04). An acceptable acute dermal toxicity study demonstrated
that Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic to rats
when dosed at 5,050 mg/kg. The LD50 was greater than 5,050
mg/kg (Toxicity Category IV).
    7. Acute eye irritation--rabbit (Harmonized Guideline 870.2400;
MRID No. 479450-06). An acceptable acute eye irritation study
demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was
minimally irritating to the eyes of rabbits (irritation symptoms
cleared by 24 hours; Toxicity Category IV).
    8. Primary dermal irritation--rabbit (Harmonized Guideline
870.2500; MRID No. 479450-07). An acceptable primary dermal irritation
study demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was
slightly irritating to the skin of rabbits (irritation symptoms cleared
by 24 hours; Toxicity Category IV).
    9. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600;
MRID No. 479450-08). An acceptable dermal sensitization study
demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was not a
dermal sensitizer to guinea pigs.

IV. Aggregate Exposure

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

A. Dietary Exposure

    Dietary exposure to this microbial pesticide may occur (more likely
through food than drinking water); however, the lack of acute oral
toxicity, as exhibited in a toxicology test on rats, and the rationales
justifying the waiver of acute oral toxicity/pathogenicity testing (see
Unit III.B.), support the establishment of a tolerance exemption for
residues of Chromobacterium subtsugae strain PRAA4-1\T\.
    1. Food exposure. Any exposure to this naturally occurring soil
bacterium is anticipated to be negligible. Although Chromobacterium
subtsugae strain PRAA4-1\T\ may be applied directly to food, it is not
expected to persist or accumulate in any reservoirs on plants or food
commodities (the phyllosphere) because, as a soil microorganism, it is
best adapted to more favorable conditions underground. Rather, after
application, it likely will degrade due to predation by other
biological organisms (e.g., protists) and exposure to particular
environmental factors (e.g., sunlight and varying temperatures) (Refs.
2 and 3). Should this microbial pesticide be present on food, the acute
oral toxicity and pathogenicity data/information demonstrated no
toxicity, infectivity and/or pathogenicity is likely to occur with any
exposure level of Chromobacterium subtsugae strain PRAA4-1\T\ (see
additional discussion in Unit III.B.).
    2. Drinking water exposure. Exposure of humans to residues of
Chromobacterium subtsugae strain PRAA4-1\T\ in consumed drinking water
is unlikely. The proposed use patterns for Chromobacterium subtsugae
strain PRAA4-1\T\ do not include direct application to aquatic
environments, thereby limiting contact with surface water. Furthermore,
ground water is not expected to have significant exposure to
Chromobacterium subtsugae strain PRAA4-1\T\ since, like other
microorganisms, this bacterium would likely be filtered out by the
particulate nature of many soil types (Refs. 4, 5, and 6) and is not
known to survive in water or deep soil. If Chromobacterium subtsugae
strain PRAA4-1\T\ were to be transferred to surface or ground waters
that are intended for eventual human consumption (e.g., through spray
drift or runoff) and directed to wastewater treatment systems or
drinking water facilities, it likely would not survive the conditions
water is subjected to in such systems or facilities, including high
temperatures, chlorination, pH adjustments, and/or filtration (Refs. 7
and 8). In the remote likelihood that this microbial pesticide is
present in drinking water (e.g., in water not subject to treatment
systems or facilities), the acute oral toxicity and pathogenicity data/
information demonstrated no toxicity, infectivity and/or pathogenicity
is likely to occur with any exposure level of Chromobacterium subtsugae
strain PRAA4-1\T\ (see additional discussion in Unit III.B.).

B. Other Non-Occupational Exposure

    Dermal and inhalation non-occupational exposure to Chromobacterium
subtsugae strain PRAA4-1\T\ is not expected as all proposed pesticide
applications will take place in distinct agricultural settings. Even if
dermal and inhalation non-occupational exposures were to occur, such
exposures would not exceed EPA's level of concern given testing that
indicated that Chromobacterium subtsugae strain PRAA4-1\T\ is not toxic
(acute inhalation and dermal toxicity), is only slightly irritating
(primary dermal irritation), is not a sensitizer (dermal
sensitization), and is not pathogenic or infective (acute injection
toxicity/pathogenicity) (see additional discussion in Unit III.B.).

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

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a

tolerance exemption, EPA consider ``available information concerning
the cumulative effects of [a particular pesticide's] * * * residues and
other substances that have a common mechanism of toxicity.''
    EPA has not found Chromobacterium subtsugae strain PRAA4-1\T\ to
share a common mechanism of toxicity with any other substances, and
Chromobacterium subtsugae strain PRAA4-1\T\ does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has assumed that Chromobacterium
subtsugae strain PRAA4-1\T\ does not have a common mechanism of
toxicity with other substances. Following from this, therefore, EPA
concludes that there are no cumulative effects associated with
Chromobacterium subtsugae strain PRAA4-1\T\ that need to be considered.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the Food Quality Protection Act Safety
Factor. In applying this provision, EPA either retains the default
value of 10X or uses a different additional safety factor when reliable
data available to EPA support the choice of a different factor.
    Based on the acute toxicity and pathogenicity data/information
discussed in Unit III.B., EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to the residues of
Chromobacterium subtsugae strain PRAA4-1\T\. Such exposure includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. EPA has arrived at this conclusion because,
considered collectively, the data (e.g., lack of toxicity noted for
oral, dermal, and inhalation routes of exposure) available on
Chromobacterium subtsugae strain PRAA4-1\T\ do not demonstrate toxic,
pathogenic, and/or infective potential to sensitive populations from
exposure to this microbial pest control agent. Thus, there are no
threshold effects of concern and, as a result, an additional margin of
safety is not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. In this
context, EPA considers the international maximum residue limits (MRLs)
established by the Codex Alimentarius Commission (Codex), as required
by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Chromobacterium subtsugae
strain PRAA4-1\T\.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of Chromobacterium subtsugae strain
PRAA4-1\T\. Therefore, an exemption from the requirement of a tolerance
is established for residues of Chromobacterium subtsugae strain PRAA4-
1\T\ in or on all food commodities when applied as an insecticide or
miticide and used in accordance with good agricultural practices.

IX. References

1. U.S. EPA. 2011. Chromobacterium subtsugae strain PRAA4-1\T\
Biopesticides Registration Action Document dated July 2011
(available as ``Supporting & Related Material'' within docket ID
number EPA-HQ-OPP-2010-0058 at http://www.regulations.gov).
2. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background
for Residue Analysis of Microbial Pest Control Agents (OPPTS
885.2000). Available from http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
3. Lindow SE, Brandl MT. 2003. Microbiology of the phyllosphere.
Applied and Environmental Microbiology 69:1875-1883.
4. Pang L, McLeod M, Aislabie J, [Scaron]im[uring]nek J, Close M,
Hector R. 2008. Modeling transport of microbes in ten undisturbed
soils under effluent irrigation. Vadose Zone Journal 7:97-111.
5. Aislabie J, Smith JJ, Fraser R, McLeod M. 2001. Leaching of
bacterial indicators of faecal contamination through four New
Zealand soils. Australian Journal of Soil Research 39:1397-1406.
6. DeFelice K, Wollenhaupt N, Buchholz D. 1993. Aquifers and Soil
Filter Effect. Available from http://extension.missouri.edu/p/WQ24.
7. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment
Systems. EPA 832-R-04-001. Available from http://www.epa.gov/npdes/pubs/primer.pdf.
8. Centers for Disease Control and Prevention. 2009. Drinking
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to EPA. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in

Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, 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. As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require EPA consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

XI. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 26, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.1305 is added to subpart D to read as follows:

Sec.  180.1305  Chromobacterium subtsugae strain PRAA4-1\T\; exemption
from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Chromobacterium subtsugae strain PRAA4-1\T\ in or on all
food commodities when applied as an insecticide or miticide and used in
accordance with good agricultural practices.

[FR Doc. 2011-22868 Filed 9-6-11; 8:45 am]
BILLING CODE 6560-50-P