[Federal Register Volume 74, Number 102 (Friday, May 29, 2009)]
[Rules and Regulations]
[Pages 25645-25650]
[FR Doc No: E9-12532]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 61

[Docket No.: FAA-2002-13744; Amendment No. SFAR 73-2]
RIN 2120-AJ27

Robinson R-22/R-44 Special Training and Experience Requirements

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action continues the existing special training and
experience requirements in Special Federal Aviation Regulation (SFAR)
No. 73 until the SFAR is revised or rescinded. SFAR No. 73 requires
special training and experience for pilots operating the Robinson model
R-22 or R-44 helicopters in order to maintain the safe operation of
these helicopters. SFAR No. 73 also requires special training and
experience for certified flight instructors conducting student
instruction or flight reviews in the R-22 or R-44.

DATES: This amendment becomes effective June 29, 2009.

FOR FURTHER INFORMATION CONTACT: For technical questions about this
final rule contact John D. Lynch, Certification and General Aviation
Operations Branch, AFS-810, General Aviation and Commercial Division,
800 Independence Avenue SW., Washington, DC 20591; telephone (202) 276-
8212. For legal questions about this final rule contact Mike Chase,
Office of Chief Counsel, 800 Independence Avenue, SW., Washington, DC
20591, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106,
describes the authority of the FAA Administrator, including the
authority to issue, rescind, and revise regulations. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Chapter 447--Safety Regulation. Under section
44701, the FAA is charged with promoting safe flight of civil aircraft
in air commerce by prescribing regulations necessary for safety. Under
section 44703, the FAA issues an airman certificate to an individual
when we find, after investigation, that the individual is qualified
for, and physically able to perform the duties related to, the position
authorized by the certificate. In this final rule, we continue the
existing special training and experience requirements in Special
Federal Aviation Regulation (SFAR) No. 73 and eliminate the termination
date for SFAR No. 73 until further notice. This final rule ensures
pilots have the training and experience necessary to operate these
models of Robinson helicopters safely. For this reason, the final rule
is within the scope of our authority and is a reasonable and necessary
exercise of our statutory obligations.

I. Background

    Part 61 of Title 14 of the Code of Federal Regulations (14 CFR part
61) details the certification requirements for pilots and flight
instructors. Particular requirements for pilots and flight instructors
in rotorcraft are found in Subparts C through G, and Appendix B of part
61. These requirements do not address any specific type or model of
rotorcraft. However, in 1995 the Federal Aviation Administration
(referred to as ``we'') determined that specific training and
experience requirements are necessary for the safe operation of
Robinson R-22 and R-44 model helicopters.
    The R-22 is a 2-seat, reciprocating engine powered helicopter that
is frequently used as a low-cost initial student training aircraft. The
R-44 is a 4-seat helicopter with operating characteristics and design
features that are similar to the R-22. The R-22 is the smallest
helicopter in its class and incorporates a unique cyclic control and
teetering rotor system. Certain aerodynamic and design features of the
aircraft cause specific flight characteristics that require particular
pilot awareness and responsiveness.
    We found the R-22 met 14 CFR part 27 certification requirements and
issued a type certificate in 1979. The small size and relatively low
operating costs of this helicopter made it popular as a training or
small utility aircraft. Thus, a significant number of the pilots
operating R-22 helicopters were relatively inexperienced. Before
issuance of SFAR No. 73 in 1995, the Robinson R-22 experienced a higher
number of fatal accidents due to main rotor/airframe contact than other
piston-powered helicopters. Many of these accidents were caused by low
rotor revolutions per minute (RPM) or low ``G'' conditions that
resulted in mast bumping or main rotor-airframe contact accidents.
Aviation safety authorities attributed these accidents to pilot error
by inexperienced pilots. In our analysis of accident data prior to the
first issuance of SFAR No. 73, we found that apparently qualified
pilots may not be properly prepared to safely operate the R-22 and R-44
helicopters in certain flight conditions. Accidents in the R-22 and R-
44 helicopters have declined markedly since SFAR No. 73 was issued.

II. Previous Regulatory Action

    On March 1, 1995, the FAA published SFAR No. 73 (60 FR 11256). This
SFAR required certain experience and training to perform pilot-in-
command or certified flight instructor duties. SFAR No. 73 was issued
on an emergency basis, with an expiration date of December 31, 1997. On
November 21, 1997 the FAA published an NPRM (62 FR 62486) to extend
SFAR No. 73 to December 31, 2002. The final rule (63 FR 660) extending
SFAR No. 73 to December 31, 2002, was published on January 7, 1998. On
November 14, 2002, the FAA published an NPRM (67 FR 69106) proposing to
extend SFAR No. 73 an additional 5 years. On January 2, 2003, we
reissued SFAR No. 73 (68 FR 39) and extended the rule's expiration date
to March 31, 2008. On March 31, 2008, we extended SFAR No. 73 until
June 30, 2009 (73 FR 17243). On August 7, 2008, we published an NPRM
proposing to eliminate the termination date for SFAR No. 73.

III. Summary of Comments

    The FAA received 3 brief (one page) comments in response to the
proposed rule. All the commenters acknowledged the valuable safety
benefits of SFAR No. 73 since 1995, though one commenter thought
continuing the SFAR was no longer necessary because of the helicopter
community's awareness of the flight characteristics and risks of 2-
blade teetering rotor systems. Two commenters were generally supportive
of continuing an SFAR for the R-22 and R-44 helicopters, though both
commenters thought updating and fine tuning the regulation was needed.
All three commenters focused on possible changes that relate to the
separate requirements for each model that apply to both piloting and
instructing in each model. Lowering the hours required for operating or
training in the R-44 was suggested in the context of moving from the R-
22 model to the R-44.
    One commenter stated that since the adoption of SFAR No. 73 in
1995, the Robinson Helicopter Company has made modifications that
affect the R-22 and R-44 fleets. These modifications include a
mandatory RPM governor, higher performance engines, hydraulic-

assisted controls, new aircraft placards, and changes to the
limitations and normal procedures in the aircraft flight manual.
Additionally, this commenter noted that the FAA has updated the
Rotorcraft Flying Handbook, FAA-H8083-21, and modified the Practical
Test Standards for the helicopter rating practical tests to provide
emphasis on the hazards associated with low G flight, mast bumping, and
low RPM. This commenter suggested that the FAA establish a Flight
Standardization Board (FSB) to evaluate the current situation with
these helicopters and make any needed amendments to the SFAR prior to
adopting a rule without an expiration date.
    The FAA notes that none of the commenters provided any detailed
information or data about the current fleet of R-22 and R-44
helicopters. Similarly, none of the commenters analyzed current
accident data for the R-22 and R-44 helicopters or provided a safety
analysis to support their conclusions.
    In the FAA's view, the safety importance of SFAR 73 clearly has
been demonstrated. The accident rate for the Robinson R-44 and R-22
helicopter has declined precipitously since SFAR No. 73 was established
in 1995. Looking at recent data, the accident records and contributing
causes of nearly 100 Robinson R-22 accidents that occurred between 2005
and 2008 show that none of the accidents involved mast bumping, low
rotor RPM, or low ``G'' hazards. The additional training required by
SFAR No. 73 addresses these specific hazards. Based on the record of
effectiveness, even if not solely attributed to SFAR 73, the FAA has
determined that reliance on the general awareness in the helicopter
community of the operating issues of the R-22 and R-44 helicopters is
not consistent with safety.
    Nor, does the FAA believe that we need to conduct another FSB for
the R-22 and R-44 helicopters before adopting SFAR No. 73 as proposed.
In the case of the R-22, the FAA has conducted two FSBs. At the
conclusion of the second FSB in the early 1990s, we established the
additional training and qualification requirements contained in SFAR
No. 73. While modifications made by the Robinson Helicopter Company to
the R-22 and R-44 fleets may have improved the R-22 and R-44
helicopters, the FAA believes the additional training and qualification
requirements in SFAR No. 73 contributed significantly to reducing the
number and types of accidents traditionally associated with these
helicopters.
    The FAA continues to analyze the number of Robinson R-22 and R-44
accidents in comparison to other makes and models of helicopters. Using
the most recent data (2007), Table 1 shows the activity level of the
pertinent models of helicopters and number of accidents involving
Robinson R-22 and R-44 helicopters in comparison to Schweizer 269 and
Enstrom 280 helicopters. These types of helicopters are generally used
in the training environment for initial pilot certification.

         Table 1--2007 General Aviation and Air Taxi Survey by Population Size, Active Helicopters, Total Flight Hours, and Average Flight Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Aircraft                  Percent        Est.       Percent                   Percent        Est.       Percent
       Helicopter make/model          population  Est. number    standard     percent      standard    Est. total    standard     average      standard
                                         size        active       error        active       error     hours flown     error        hours        error
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enstrom 280........................          143          108          0.8         75.4          0.8        6,473         12.2         60.0          9.2
Schweizer 269......................          403          366          0.4         90.7          0.4      147,936          6.0        404.7          5.4
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........          474  ...........  ...........  ...........      154,409  ...........        325.8  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
R-22...............................          948          863          0.5         91.1          0.5      330,883          5.3        383.2          4.8
R-44...............................        1,022          999          0.2         97.8          0.2      184,624          5.0        184.8          4.9
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........        1,862  ...........  ...........  ...........      515,507  ...........        276.9  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Enstrom 280 and Schweizer 269 Accident Rate in Comparison to the
                  Robinson R-22 and R-44 Accident Rate
------------------------------------------------------------------------
                                                       Accident rate per
         Helicopter type               Number of       100,000 hours of
                                      accidents *      flight time flown
------------------------------------------------------------------------
Enstrom 280 and Schweizer 269...                  18               11.66
Robinson R-22 and R-44..........                  54               10.48
------------------------------------------------------------------------
* Accident data from the U.S. National Transportation Safety Board.

    The data show the accident rate for the Robinson R-22 and R-44 per
100,000 hours of flight is 10.48. While the accident rate is slightly
lower than the accident rate of 11.66 per 100,000 hours of flight for
similar training helicopters, the roughly comparable accident rate has
been achieved in the context of the special training requirements of
SFAR 73. (If the comparison included only the R-22, which sees more use
as a training aircraft, the accident rate for the R-22 would be higher
than the rate for the Enstrom 280 and the Schweizer 269.) We conclude
that the additional training and qualification requirements in SFAR No.
73 have been a major factor leading to an improved safety record for
the Robinson R-22 and R-44 helicopter in the training environment.
    Table 2 shows the activity level of the pertinent models of
helicopters and contains data comparing the accident rate in the
Robinson R-22 and R-44 helicopter to the accident rate of helicopters
which have a similar teetering or semi-rigid rotor system (Bell 206,
Bell 47G, and Hiller UH-12E) as the Robinson R-22 and R-44 helicopter.

         Table 2--2007 General Aviation and Air Taxi Survey by Population Size, Active Helicopters, Total Flight Hours, and Average Flight Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Aircraft                  Percent        Est.       Percent                   Percent        Est.       Percent
       Helicopter make/model*         population  Est. number    standard     percent      standard    Est. total    standard     average      standard
                                         size        active       error        active       error     hours flown     error        hours        error
--------------------------------------------------------------------------------------------------------------------------------------------------------
BH-206.............................        1,650        1,448          0.5         87.7          0.5      589,158          3.1        407.0          2.7
BH-47G.............................          615          322          1.4         52.4          1.4       41,167         13.0        127.7          6.8
UH-12E.............................          253          119          1.6         47.1          1.6       28,131         11.4        236.1          5.4
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........        1,889  ...........  ...........  ...........      658,456  ...........        348.6  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
R-22...............................          948          863          0.5         91.1          0.5      330,883          5.3        383.2          4.8
-44................................        1,022          999          0.2         97.8          0.2      184,624          5.0        184.8          4.9
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........        1,862  ...........  ...........  ...........      515,507  ...........        276.9  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

 Bell and Hiller Accident Rate in Comparison to the Robinson R-22 and R-
                            44 Accident Rate
------------------------------------------------------------------------
                                                       Accident rate per
         Helicopter type               Number of       100,000 hours of
                                     accidents **      flight time flown
------------------------------------------------------------------------
Bell and Hiller Helicopters.....                  49                7.44
Robinson R-22 and R-44..........                  54               10.48
------------------------------------------------------------------------
* Bell Helicopter 206=BH-206; Bell Helicopter 47G=BH-47G; Hiller UH-
  12E=UH-12E; Robinson R-22=R-22; and Robinson R-44=R-44.
** Accident data from the U.S. National Transportation Safety Board.

    The data in Table 2 show the accident rate per 100,000 hours of
flight for the Robinson R-22 and R-44 is higher than the accident rate
of the Bell 206, Bell 47G, and Hiller UH-12E, 10.48 compared to 7.44,
respectively. While the helicopters being compared are different in
other ways, nothing in the data suggests a reason to reduce the
training requirements of SFAR 73.
    The FAA is willing to work with the helicopter industry, owners of
Robinson R-22 and R-44 helicopters, and the Robinson Helicopter Company
to evaluate any data, information, or safety analyses provided that
might lead to future modification of SFAR No. 73. Adopting the rule
without a specific expiration date is not a hindrance to modifying the
rule based on updated data and analysis. At this time, however, the FAA
does not believe an adequate safety rationale has been developed to
warrant specific modifications to the current requirements.

Paperwork Reduction Act

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

International Compatibility

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

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

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
Tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this final rule. We suggest readers seeking
greater detail read the full regulatory evaluation, a copy of which we
have placed in the docket for this rulemaking.
    In conducting these analyses, FAA has determined that this final
rule: (1) Has benefits that justify its costs, (2) is not an
economically ``significant regulatory action'' as defined in section
3(f) of Executive Order 12866, (3) is not ``significant'' as defined in
DOT's Regulatory Policies and Procedures; (4) will not have a
significant economic impact on a substantial number of small entities;
(5) will not create unnecessary obstacles to the foreign commerce of
the United States; and (6) will not impose an unfunded mandate on
State, local, or Tribal governments, or on the private sector by
exceeding the threshold identified above. These analyses are summarized
below.

Total Benefits and Costs of This Rule

    The final rule will require those who receive or provide
instruction in a Robinson R-22 or R-44 helicopter to incur additional
costs related to special training and experience requirements. These
requirements will impose costs of

approximately $9.8 million (present value, $6.9 million) over 10 years
in 2008 dollars. The potential safety benefits from the rule will be a
reduction in the number of fatal accidents that occur in Robinson
helicopters associated with low ``G'' maneuvers that may result in main
rotor/airframe contact. The reduction in the number of accidents would
be due to the increased level of safety due to specific flight training
and awareness training requirements for all individuals operating
Robinson R-22 and R-44 aircraft. SFAR 73 is estimated to avert 22
fatalities associated with low ``G'' maneuvers, and the expected
corresponding safety benefits will be approximately $129 million
(present value, $90.6 million) over ten years, in 2008 dollars. Since
benefits exceed costs, the FAA concludes that this rule is cost-
beneficial.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 establishes ``as a principle
of regulatory issuance that agencies shall endeavor, consistent with
the objective of the rule and of applicable statutes, to fit regulatory
and informational requirements to the scale of the business,
organizations, and governmental jurisdictions subject to regulation.''
To achieve that principle, the Act requires agencies to solicit and
consider flexible regulatory proposals and to explain the rationale for
their actions. The Act 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 proposed or
final rule will have a significant economic impact on a substantial
number of small entities. If the determination is that it will, the
agency must prepare a regulatory flexibility analysis (RFA) as
described in the Act.
    However, if an agency determines that a proposed or final rule is
not expected to have a significant economic impact on a substantial
number of small entities, section 605(b) of the 1980 Act provides that
the head of the agency may so certify and an RFA is not required. The
certification must include a statement providing the factual basis for
this determination, and the reasoning should be clear.
    This final rule will indefinitely extend SFAR 73, initially
published on March 1, 1995, and extended three times since. The SFAR is
limited to experience and training requirements to perform pilot-in-
command and certified flight instructor duties, thereby impacting
individuals rather than entities. Therefore, as the Acting FAA
Administrator, I certify that this final rule will not have a
significant economic impact on a substantial number of small entities.

International Trade Analysis

    The Trade Agreement Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-463), prohibits Federal
agencies from engaging in any standards or related activities that
create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered unnecessary obstacles to the foreign commerce of the United
States, so long as the standards have a legitimate domestic objective,
such as the protection of safety, and do not operate in a manner that
excludes imports that meet this objective. The statute also requires
consideration of international standards and where appropriate, that
they be the basis for U.S. standards. The FAA notes the purpose is to
ensure the safety of the American public, and has assessed the effects
of this rule to ensure it does not exclude imports that meet this
objective. As a result, this final rule is not considered as creating
an unnecessary obstacle to foreign commerce.

Unfunded Mandates Assessment

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

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the Federal Government and the States, or on the
distribution of power and responsibilities among the various levels of
government, and, therefore, does not have federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 6 and involves no extraordinary
circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

    The FAA has analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a ``significant regulatory action'' under the executive order because
it is not a ``significant regulatory action'' under Executive Order
12866, and DOT's Regulatory Policies and Procedures, and it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or
    3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://DocketsInfo.dot.gov.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with

small entity requests for information or advice about compliance with
statutes and regulations within its jurisdiction. If you are a small
entity and you have a question regarding this document, you may contact
your local FAA official, or the person listed under the FOR FURTHER
INFORMATION CONTACT heading at the beginning of the preamble. You can
find out more about SBREFA on the Internet at http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 61

    Aircraft, Aircraft pilots, Airmen, Airplanes, Air safety, Air
transportation, Aviation safety, Balloons, Helicopters, Rotorcraft,
Students.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends Chapter I of Title 14, Code of Federal Regulations as follows:

PART 61--CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND
INSTRUCTORS

0
1. The authority citation for part 61 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

0
2. Revise section 3 of SFAR No. 73 to read as follows:

Special Federal Aviation Regulation No. 73--Robinson R-22/R-44 Special
Training and Experience Requirements

* * * * *
0
3. Expiration date. This SFAR No. 73 shall remain in effect until it is
revised or rescinded.

    Issued in Washington, DC, on May 26, 2009.
Lynne A. Osmus,
Acting Administrator.
[FR Doc. E9-12532 Filed 5-28-09; 8:45 am]
BILLING CODE 4910-13-P


1 EPA Registration Division contact: By Mail: George T. LaRocca, Product Manager ( PM) 13, Registration Division ( 7505C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: CM 2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, ( 703) 305 6100; e mail: larocca. george@ epa. gov Interregional Research Project Number 4 ( IR 4)

IR 4 P. R. No. 9E5075 EPA has received an amendment to a pesticide petition ( IR 4 P. R. No. 9E5075) from Interregional Research Project Number 4 ( IR 4), 681 U. S. Highway 1 South, North Brunswick, NJ 08902 3390 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.533 by establishing tolerances for residues of the insecticide, esfenvalerate (( S) cyano( 3 phenoxyphenyl) methyl( S) 4 chloro alpha( 1 methylethyl) benzeneacetate) in or on the Oilseed Crop Group 20 which includes the following raw agricultural commodities: rapeseed ( canola, seed) at 0.3 ppm, Indian rapeseed at 0.3 ppm, Indian mustard, seed at 0.3 ppm, field mustard, seed at 0.3 ppm, black mustard, seed at 0.3 ppm, flax, seed at 0.3 ppm, sunflower, seed at 0.3 ppm, safflower, seed at 0.3 ppm, borage, seed at 0.3 ppm and crambe, seed at 0.3 ppm.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. This notice includes a summary of the petitions prepared by DuPont Crop Protection,( formerly DuPont Agricultural Products), P. O. Box 30, Newark, DE 19714 0030.

A. Residue Chemistry 1. Plant metabolism. The metabolism and chemical nature of residues of fenvalerate in plants and animals are adequately understood. The fate of fenvalerate has been extensively studied using radioactive tracers in plant and animal metabolism/ nature of the residue studies. These studies have demonstrated that the parent compound is the only residue of toxicological significance. EPA has concluded that the qualitative nature of the residue is the same for both fenvalerate and esfenvalerate.

2. Analytical method. There is a practical analytical method utilizing electron capture gas chromatography with nitrogen phosphorous detection available for enforcement with a limit of detection that allows monitoring food with residues at or above tolerance levels. The limit of detection for updated method is the same as that of the current PAM II, which is 0.01 ppm. 2 3. Magnitude of residues. Fenvalerate is a racemic mixture of four isomers about 25% each. Technical Asana ® , the S, S isomer enriched formulation, esfenvalerate, has been the only fenvalerate formulation sold in the U. S. for agricultural use. Since the S, S isomer is the insecticidally active isomer, the use rate for Asana ® is 4 times lower than that for Pydrin ® . A petition is pending ( PP 4F4329), to convert tolerances still to be expressed as the sum of all isomers based on the use rates for Asana ® . Bridging residue studies have shown Asana ® residues to be 3 4 times lower than Pydrin ® residues. Field trials were conducted on canola ( pending PP 9E5075) and sunflower ( tolerance previously established for fenvalerate at 1.0 ppm), the representative commodities for the Oilseed Crop Group. Results from these trials support the proposed tolerances.

B. Toxicological Profile As assessment of the toxic effects caused by esfenvalerate is discussed in Unit III. A. and Unit III. B. of the Federal Register dated March 1, 2001 ( 66 FR 16926) ( FRL 6774 5).

1. Animal metabolism. In animal studies, after oral dosing with radioactive fenvalerate, the majority of the administered radioactivity was eliminated in the initial 24 hours. The metabolic pathway involved cleavage of the ester linkage followed by hydroxylation, oxidation, and conjugation of the acid and alcohol moieties.

2. Metabolite toxicology. The parent molecule is the only moiety of toxicological significance appropriate for regulation in plant and animal commodities.

C. Aggregate Exposure 1. Dietary exposure. Tolerances have been established for the residues of fenvalerate/ esfenvalerate, in or on a variety of agricultural commodities. For purposes of assessing dietary exposure, chronic and acute dietary assessments have been conducted using all existing tolerances for esfenvalerate. The following crops with pending petitions have been included in the assessment: Brussels sprouts; cabbage, Chinese, bok choy; canola; cardoon; sweet potato, and pistachio. In addition, previously pending or intended uses that have been withdrawn ( leaf lettuce, kale, passion fruit) are also included in the dietary exposure assessment.

i. Food. a. Chronic. A chronic dietary exposure assessment was conducted using Novigen's Dietary Exposure Estimate Model ( DEEM ® ) . Anticipated residues and adjustment for percent crop treated were used in the chronic dietary risk assessment. The percentages of the reference dose ( RfD) utilized by the most sensitive subpopulation, children 1 6 years, was 2.0% based on a daily dietary exposure of 0.000134 milligrams/ kilogram body weight/ day ( mg/ kg bwt/ day). Chronic exposure for the overall US population was 0.9% of the RfD based on a dietary exposure of 0.000058 mg/ kg bw/ day. EPA has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure 3 over a lifetime will not pose appreciable risks to human health. b. Acute exposure. Potential acute exposures from food commodities were estimated using a Tier 3 ( Monte Carlo) Analysis, appropriate processing factors for processed food, and distribution analysis. This analysis used data from field trial studies and pesticide monitoring programs to estimate exposure, and federal and market survey information to derive the percent of crop treated. These data are considered reliable, and used the upper end estimate of percent crop treated in order to not underestimate any significant subpopulation. Regional consumption information was taken into account.

ii. Drinking water. Esfenvalerate is immobile in soil and will not leach into ground water. Due to the insolubility and lipophilic nature of esfenvalerate, any residues in surface water will rapidly and tightly bind to soil particles and remain with sediment, therefore not contributing to potential dietary exposure from drinking water. Surface water concentrations for pyrethroids were estimated using PRZM3 and Exposure Analysis Modeling System ( EXAMS) using Standard EPA cotton runoff and Mississippi pond scenarios. The maximum concentration predicted in the simulated pond was 0.052 parts per billion ( ppb). Concentrations in actual drinking water would be much lower than the levels predicted in the hypothetical, small, stagnant farm pond model since drinking water derived from surface water would be treated before consumption. Chronic drinking water exposure has been estimated to be 0.000001 mg/ kg/ day for both the U. S. general population and for non nursing infants. Therefore, DuPont believes that there is a reasonable certainty of no harm from drinking water.

2. Non dietary exposure. Esfenvalerate is registered for non crop uses including spray treatments in and around commercial and residential areas, treatments for control of ectoparasites on pets, home care products including foggers, pressurized sprays, crack and crevice treatments, lawn and garden sprays, and pet and pet bedding sprays. For the non agricultural products, the very low amounts of active ingredient they contain, combined with the low vapor pressure ( 1.5 x 10 9 mm Mercury at 25 deg. C.) and low dermal penetration, would result in minimal inhalation and dermal exposure. To assess risk from nonfood short term and intermediate term exposure, EPA has selected a toxicological endpoint of 2.0 mg/ kg/ day, the NOAEL from the rat and rabbit developmental studies. For dermal penetration/ absorption, EPA selected 25% dermal absorption based on the weight of evidence available for structurally related pyrethroids. For inhalation exposure, EPA used the oral NOAEL of 2.0 mg/ kg/ day and assumed 100% absorption by inhalation. Individual non dietary risk exposure analyses were conducted using a flea infestation scenario that included pet spray, carpet and room treatment, and lawn care, respectively. The total potential short term and intermediate term aggregate non dietary exposure including lawn, carpet, and pet uses are: 0.000023 mg/ kg/ day for adults, 0.00129 mg/ kg/ day for children 1 6 years old, and 0.00138 mg/ kg/ day for infants less than 1 year old. EPA concluded in a final rule published in the Federal Register of November 26, 1997 ( 62 FR 63019) ( FRL 5754 6) that the potential non dietary exposure for esfenvalerate is associated with 4 substantial margins of safety, and that there was reasonable certainty that no harm will result from aggregate exposure to esfenvalerate residues.

D. Cumulative Effects Section 408 ( b) ( 2) ( D) ( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider    available information'' concerning the cumulative effects of a particular pesticide's residues and    other substances that have a common mechanism of toxicity''. EPA does not have at this time available data to determine whether esfenvalerate has a common method of toxicity with other substances, or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, esfenvalerate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that esfenvalerate has a common mechanism of toxicity with other substances.

E. Safety Determination 1. U. S. population. Based on the chronic dietary exposure assessment, it is concluded that exposure to esfenvalerate, including the proposed uses in food will utilize approximately 0.9% of the RfD for the U. S. general population. There is generally no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. The margin of exposure ( MOE) for the general population was 472 at the 99.9th percentile of exposure, based on a daily exposure estimate of 0.004229 mg/ kg bwt/ day. Therefore, there is a reasonable certainty that no harm to the U. S. population will result from chronic dietary, acute dietary, non dietary, or aggregate exposure to esfenvalerate residues.

2. Infants and children. FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for prenatal and postnatal effects, and the completeness of the toxicity data base. An extra 3X safety factor has been assessed for esfenvalerate due to a data gap. A chronic dietary exposure assessment found the percentages of the RfD utilized by the most sensitive subpopulation to be 2.0% for children 1 6 years old based on a dietary exposure of 0.000134 mg/ kg bw/ day. The most sensitive subpopulation, children 1 6 years, had acute dietary MOE of 378 at the 99.9th percentile of exposure. Nursing infants had a MOE of 750 at the 99.9th percentile of exposure. Non nursing infants had a MOE of 761at the 99.9th percentile of exposure. Therefore, there is a reasonable certainty that no harm to infants and children will result from chronic dietary, acute dietary, non dietary, or aggregate exposure to esfenvalerate residues. 5 F. International Tolerances Codex maximum residue levels ( MRL's) have been established for residues of fenvalerate on a number of crops that also have U. S. tolerances. There are some minimal differences between the section 408 tolerances and certain Codex MRL values for specific commodities. These differences could be caused by differences in methods to establish tolerances, calculate animal feed, dietary exposure, and as a result of different agricultural practices. Therefore, some harmonization of these maximum residue levels may be required.