On April 16, 1996, Ayres Corporation applied for a type certificate for their new Model LM 200 and reapplied in May 1997 adding passenger and combi configurations. The Model LM 200 airplane will have a 19,000 pound maximum takeoff weight with a payload capacity of about 7,500 pounds. The propulsion system will consist of a Light Helicopter Turbine Engine Company (LHTEC) CTP800-4T powerplant driving a single Hamilton Standard Model 568F-11, 12.9-foot diameter, propeller. The powerplant consists of two LHTEC CTS800 derivative turboprop engines plus a combining gearbox. The powerplant will be certified to 14 CFR part 33 and identified as a twin power section turboprop assembly. The two turboprop engines will be certified as part of the twin power section turboprop assembly (powerplant) and will not have separate individual type certificates. The airplane will be of conventional, semi-monocoque, aluminum construction with a high cantilever wing, fixed gear, mechanical and electro-mechanical controls and will be unpressurized. Certification will include flight into known icing and single pilot, IFR operations. Three interior configurations have been proposed: a cargo configuration (bulk or containerized cargo), a nine-passenger configuration, and “combi” (combination of up to nine passengers and cargo).

Under the provisions of 14 CFR 17, Ayres Corporation must show that the Model LM 200 meets the applicable provisions of part 23 as amended by Amendments 23-1 through Amendment 53, effective April 30, 1998.

If the Administrator finds that the applicable airworthiness regulations (i.e., part 23) do not contain adequate or appropriate safety standards for the Model LM 200 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Model LM 200 must comply with the part 23 fuel vent and exhaust emission requirements of 14 CFR part 34 and the part 23 noise certification requirements of 14 CFR part 36. Also, the FAA must issue a finding of regulatory adequacy pursuant to § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38, and become part of the type certification basis in accordance with § 21.17(a)(2).

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101(a)(1).

The following definitions will apply to the Ayres Model LM 200 airplane design:

Powerplant—The Light Helicopter Turbine Engine Company (LHTEC) Model CTP800-4T powerplant, consists of two CTS800 derivative turboprop engines, a GKN Westland combining gearbox (CGB), and the engine assembly support structure. The powerplant is capable of providing 2,700 shp combined output power at takeoff and 1,350 shp with one engine inoperative. The CTP800-4T powerplant will obtain a part 33 type certificate identifying the powerplant as a “twin power section turboprop assembly.”

Engine—An LHTEC CTS800 derivative, non-regenerative, front drive, free turbine power section, which includes compressor, combustor, turbine and accessories group. Each engine of the CTP800-4T is separately controlled by a fully redundant full authority digital electronic control (FADEC). The two engines will only be certified as part of the CTP800-4T powerplant. The CTP800-4T type certificate data sheet will include ratings and limitations for each engine in addition to that of the powerplant.

Engine Assembly Support Structure—The supporting structure that connects the two engines to the CGB. This structure will be type certificated as part of the CTP800-4T powerplant under part 33.

Propulsion System Unit (PSU)—The Model LM 200 airplane PSU consists of the powerplant plus the airframe mounted non-integrated lubrication system components, which include the CGB oil tank and CGB/engine oil cooler, as well as a single Hamilton Sundstrand Model 568F-11 propeller system.

Combining Gearbox (CGB)—All components necessary to transmit power from the two engines to the propeller. This includes couplings, supporting bearings for shafts, brake assemblies, clutches, gearboxes, transmissions, any attached accessory pads or drives, and any cooling fans that are attached to, or mounted on, the CGB. The CGB will be type certificated as part of the CTP800-4T powerplant under part 33.

Multi-Engine—For the Model LM 200 and its powerplant configuration, “multi-engine” refers to the twin engine capability and ratings of the CTP800-4T powerplant in regard to type certification in the commuter category and flight operation.

One Engine Inoperative (OEI)—For the LM 200 airplane, “one engine inoperative” refers to a condition in which one engine of the CTP800-4T powerplant is not operational and the operation of the propeller is unchanged.

Part 23 does not contain adequate or appropriate requirements for the Ayres Model LM 200 powerplant installation of twin engines driving a single propeller through a combining gearbox. Issues include preventing unbalance damage to either the engines or the powerplant mounting system, or both, resulting from any engine or propeller single failure or probable combination of failures and the capability to continue safe flight to a landing. The propeller and other non-redundant components must be of sufficient durability to minimize any possibility of a failure that could have catastrophic implications to either the airplane or its propulsion system, or both.

Elements of these proposed special conditions have been developed to supplement part 23 standards that are considered inadequate to address the Model LM 200 airplane design, namely §§ 23.53, 23.67, 23.69, 23.75, 23.77, 23.903, 23.1191, 23.1305, 23.1583, 23.1585 and 23.1587.

Special conditions addressing the engine isolation requirements of § 23.903 were not included as the current rule is considered adequate. However, since the design of the multi-engine, single propeller Model LM 200 airplane will be significantly affected by this rule, the following comments are provided. Section 23.903(c) states, “The powerplants must be arranged and isolated from each other to allow operation, in at least one configuration, so that the failure or malfunction of any engine, or the failure or malfunction (including destruction by fire in the engine compartment) of any system that can affect an engine (other than a fuel tank if only one fuel tank is installed), will not: (1) prevent the continued safe operation of the remaining engines; or (2) require immediate action by any crew member for continued safe operation of the remaining engines.” This is a fail-safe requirement in that it takes advantage of the redundancy provided by having multiple engines that are physically separated from each other, which is intended to ensure that no single failure affecting one engine will result in the loss of the airplane (also reference § 23.903(b)(1)). In conventional twin turboprop airplanes, this isolation is, in part, provided by the inherent separation of having each engine mounted on opposite sides of the airplane driving its own propeller. Installation of the engines on either side of the airplane automatically provides a degree of separation of critical systems, such as the electrical and fuel systems, and minimizes the effect of high vibration, rotor burst failures, and engine case burn-through from the opposite engine. This separation aids in preventing any single failure from jeopardizing continued safe operation of the airplane. In contrast, the nearness of the engines to each other driving a combining gearbox with a single propeller in the Model LM 200 airplane arrangement is inherently less isolated from certain types of failure modes. As a result, many failure modes that do not pose a significant hazard on conventional multi-engine airplanes could threaten continued safe operation of the Model LM 200 airplane unless specific additional precautions are taken to prevent hazardous secondary effects.

The FAA has reviewed the part 23 standards and identified that §§ 23.53(c), 23.67(c), 23.69, 23.75, and 23.77 are inadequate to address the effects of propeller control system failure modes in a manner consistent with how these sections address specific engine failure conditions. Sections 23.1191(a) and 23.1191(b) do not adequately define the locations of firewalls needed to isolate the engines and CGB of the PSU. Additionally, the FAA has identified that § 23.1305(c) is inadequate because it does not recognize the uniqueness of the Model LM 200 PSU. Furthermore, the FAA has identified that §§ 23.1583(b), 23.1585(c), and 23.1587(a) do not recognize a propeller system installation independent from either engine. Elements of these special conditions have been developed to ensure that these unique aspects of the Model LM 200 airplane are addressed in a manner equivalent to that established by part 23 standards. The FAA's analysis and derivation of each of the special condition requirements is discussed in the “Description of Requirements” section below.

The Model LM 200 will incorporate the following novel or unusual design features:

In order to define special conditions with the goal of establishing a safety level acceptable for certification as a limited commuter category airplane, the unique configuration of the Model LM 200 single propeller, twin engine design must be addressed. The Model LM 200 PSU design has eliminated as many single point failures as feasible for this type of configuration; however, certification criteria for the remaining single point failures unique to this configuration must be considered. A System Safety Analysis of the PSU is proposed that will identify and classify all possible failures that could be hazardous or catastrophic to the Model LM 200. The System Safety Analysis will consider such factors as non-redundancy, quality of manufacture and maintenance for continued airworthiness, as well as anticipated human errors, and it will highlight critical procedures that should be considered as required inspection items. Parts identified in the PSU System Safety Analysis whose failure results in a hazardous or catastrophic event will require control via a Critical Parts Plan. Furthermore, critical failure modes that could result in hazardous or catastrophic events should be addressed with appropriate design features to mitigate the potential results of such events.

The critical parts plan should be modeled after plans required by 14 CFR part 29, § 29.602, and related advisory material in Advisory Circular 29-2C for critical rotorcraft components. In addition, best industry practices shall be utilized in the definition and implementation of these critical parts. This plan will draw the attention of the personnel involved in the design, manufacture, maintenance, and overhaul of a critical part to the special nature of the part. The plan should define the details of relevant special instructions to be included in the Instructions for Continued Airworthiness. The Instructions for Continued Airworthiness, required by § 23.1529, should contain appropriate life limits, mandatory overhaul intervals, enhanced inspection limits, periodic ultrasonic (or equivalent) inspections, enhanced annual inspections, and conservative damage limits for return to service and repair for the critical parts identified in accordance with these proposed special conditions.

A means of annunciating hazardous and catastrophic failures to the cockpit should be provided if they are not immediately identifiable to the flight crew. Appropriate inspection intervals must be proposed to address any possible latent failures, which may go undetected.

For those failure modes unique to the non-conventional Model LM 200 design that have a fail-safe designed backup, either an acceptable test or analysis, or both, must address worst case conditions to substantiate the design. Methods to periodically check the backup system shall also be provided, as appropriate. In addition, a means of annunciating failure of the primary to the cockpit should be provided if it is not immediately identifiable to the flight crew. Appropriate inspection intervals must be proposed to address any possible latent failures, which may go undetected.

Although rare, high-energy rotor unbalances due to high energy rotating machinery failures, such as a rim separation, can occur in-flight. They are typically followed quickly by either an in-flight shutdown or a pilot-commanded engine shutdown. The proposed special conditions address this short duration following a rotor failure by requiring that any high-energy vibration not affect the airworthiness of the operating engine. These vibrations could otherwise affect the operating engine in areas such as rotation (rubs), compressor surge or stall, damage to engine controls, accessories, mechanical, lubrication, fuel systems, and possible engine misalignment with respect to the gearbox. The magnitudes, frequency, and duration of such a vibration should be included in the powerplant installation manual. In addition, the vibration should not affect the structural integrity of the mounting system of either engine or the combining gearbox.

The CGB includes all parts necessary to transmit power from the engines to the propeller shaft. This includes couplings, supporting bearings for shafts, brake assemblies, clutches, gearboxes, transmissions, any attached accessory pads or drives, and any cooling fans that are attached to, or mounted on, the gearbox. The CGB for this multi-engine installation must be designed with a “continue to run” philosophy. This means that it must be able to power the propeller after failure of one engine or failure in one side of the CGB drive system, including any gear, bearing, or element expected to fail. Common failures, such as oil pressure loss or gear tooth failure, in the CGB must not compromise power output from the propulsion system.

Current engine certification regulations do not adequately address the requirements of a single combining gearbox; therefore, in addition to the engine requirements of § 23.903, the CGB will be required to complete a 200 hour endurance test that is patterned after the rotor drive system requirements of § 29.923. The endurance test is intended to exercise integration of the engines, combining gearbox, and loading characteristics of the intended propeller. Additional testing patterned after § 29.927 will address the torque and speed limits. The CGB design should contain features that include automatic disengagement of any failed engine (reference § 29.917(c)(3)), independent lubrication systems (reference § 29.1027), indicators to alert the pilot of lubrication system failure, and the capability to continue safe flight to a landing for a minimum of one-hour following pilot notification of CGB primary lubrication system failure.

The requirement for continued safe flight to a landing for a minimum of one-hour following pilot notification of CGB primary lubrication system failure stems from similarities between the Model LM 200 propulsion system and that of a typical multi-engine rotorcraft. Transport category A rotorcraft must be capable of sustaining flight for 30-minutes after the crew is notified of a drive system lubrication system failure or loss of lubricant, § 29.927(c). A rotorcraft may autorotate to a small landing area and, therefore, may find a safe landing area much sooner than a 19,000 pound airplane. For this reason, the FAA is similarly proposing that the Model LM 200 demonstrate its ability to sustain flight for one-hour, in accordance with AFM instructions for an emergency landing, after crew notification of a CGB primary lubrication system failure.

The critical parts of the CGB must also undergo a fatigue evaluation patterned after the structural requirements of § 29.571 for transport rotorcraft.

The Initial Maintenance Interval will be established during the powerplant certification testing, per § 33.90.

A rotor disc fragment should not be allowed to compromise the structural integrity of the powerplant or engine mounts. Loss of the structural integrity of the powerplant mount would be considered catastrophic for the Model LM 200 design. The powerplant and engine mount principal structural elements should be fail-safe if they could be severed during an uncontained engine failure. All other principal structural elements of the powerplant and engine mounting system should be either fail-safe or damage tolerant.

With a multi-engine, single propeller installation, the non-redundancy of the propeller system components from the propeller shaft forward becomes quite significant. In the case of the Model LM 200, Ayres Corporation must design against the possibility of a propeller-related failure that could result in catastrophic loss of the airplane. To accomplish this task, Ayres Corporation must substantiate the structural integrity of their design and must establish a critical parts program and a continued airworthiness maintenance and inspection program that ensures that the propeller is maintained in an acceptable manner.

The Model LM 200 airplane's single propeller system must be installed and maintained in such a manner as to substantially reduce or eliminate the occurrence of failures that would preclude continued safe flight and landing. To ensure the propeller installation, production, and maintenance programs are sufficient to achieve a high level of reliability, these proposed special conditions include a 2,500 cycle validation test based on enhanced requirements of § 35.41(c). The 2,500 cycles correspond to the FAA's estimated annual usage for a turboprop airplane in commercial service. An airplane cycle includes idle, takeoff, climb, cruise, and descent. The test must utilize production parts installed on the powerplant and should include a wide range of ambient and wind conditions, several full stops, and validation of scheduled and unscheduled maintenance practices. The purpose of this test is to evaluate the system for service wear conditions and start/stop cycles. It is not intended to test the propeller vibratory loads. This evaluation may be accomplished on the airplane in a combination of ground and flight cycles or on a ground test facility. If the testing is accomplished on a ground test facility, the test configuration must include the PSU and all sufficient airframe interfacing system hardware to simulate the actual airplane installation and operation.

On a conventional multi-engine airplane, the flight crew will secure an engine and feather the propeller to minimize effects of propeller imbalance. Propeller imbalance could be caused by blade failures or by propeller system failures such as loss of a de-icing boot, malfunction of a de-icing boot in icing conditions, an oil leak into a blade butt, asymmetric blade pitch, or a failure in a counterweight attachment. The Model LM 200 airplane design does not provide any means to reduce the vibration produced by an unbalanced propeller. Therefore, these proposed special conditions require that the engines, CGB, powerplant and engine mounting system, primary airframe structure, and critical systems be designed to function safely in the high vibration environment generated by these less severe propeller failures. Ayres Corporation must specify the maximum allowable propeller unbalance. This is the maximum unbalance that will not cause damage to the engines, powerplant and engine mounting system, CGB, primary airframe structure, or to any other critical equipment that would jeopardize the continued safe flight and landing of the airplane. The vibration level caused by this unbalance must not jeopardize the flight crew's ability to continue to operate the airplane in a safe manner. Any part (or parts) whose failure (or probable combination of failures) would result in a propeller unbalance greater than the defined maximum would also be classified as a critical part.

It should be shown by a combination of tests and analyses that the airplane is capable of continued safe flight and landing with the maximum propeller unbalance, which includes collateral damage caused by the unbalance event.

During continued operation for one hour with the declared maximum unbalance, the evaluation should show that the induced vibrations will not cause damage either to the primary structure of the airplane or to critical equipment that would jeopardize continued safe flight and landing. The degree of flight deck vibration should not prevent the flight crew from operating the airplane in a safe manner. This includes the ability to read and accomplish checklist procedures. This evaluation should consider the effects on continued safe flight and landing from the possible damage to primary structure, which includes but is not limited to engine mounts, inlets, nacelles, wing, and flight control surfaces. Consideration should also be given to the effects of vibratory loads on critical equipment (including connectors) mounted on the engine or airframe.

In the unique design of the Model LM 200 CGB, the FAA understands that reverse rotation of the propeller on the ground would engage the sprag clutch. In turn, this would drive both engines without lubrication of the engine bearings or gearbox and cause possible damage to those elements; therefore, a means must be provided to prevent any adverse effects resulting from propeller “wind-milling” on the ground.

The Hamilton Sundstrand Model 586F-11 propeller meets special conditions imposed during the propeller type certification program (Docket Nos. 94-ANE-60 and 94-ANE-61). The propeller special conditions addressed electronic propeller and pitch control systems, a four-pound bird strike, lightning strike and fatigue. If the propeller had not been required to meet those conditions during its type certification program, the FAA would have required similar measures in these Model LM 200 special conditions since the propeller is an especially critical component on this airplane. To meet the airplane requirements for the Model LM 200, the Instructions for Continued Airworthiness may need to be modified.

For this propeller control system, no probable multiple failures were identified that create a hazardous condition; therefore, these special conditions were written to consider single point failures in the primary propeller control system only.

These proposed special conditions require the propeller control system to be independent of the engines such that a failure of any engine or the engine's control system will not result in failure or inability to control the propeller.

Ayres Corporation plans to address these special conditions by providing a mechanical high pitch stop, which would be set to a “get home” pitch position, thereby preventing the propeller blades from rotating to a feather pitch position when oil pressure is lost in the propeller control system. This would allow the propeller to continue to produce a sufficient level of thrust as a fixed pitch propeller.

In the event the propeller undergoes an uncommanded pitch change, these proposed special conditions require that the Model LM 200 airplane not be placed in an unsafe condition. They also require that an indication of the failure be provided to the flight crew.

On a conventional multi-engine airplane, the pilot has positive indication of an inoperative engine created by the asymmetric thrust condition. The airplane will not yaw when an engine or a portion of the CGB fails because of the centerline thrust of the Model LM 200 airplane propulsion system installation. The flight crew will have to rely on other means to determine which engine or CGB element has failed in order to secure the correct engine. Therefore, these proposed special conditions require that a clear indication of an inoperative engine or a failed portion of the CGB must be provided. This is necessary to preclude confusion by the flight crew in reacting to the failure and when taking appropriate action to secure the airplane in a safe condition for continued flight.

Section 23.1305 requires instruments for the fuel system, engine oil system, fire protection system, and propeller control system. This rule is intended for powerplants consisting of a single engine, gearbox, and propeller. To protect the portions of the PSU that are independent of the engines, additional instrumentation, including gearbox oil pressure, oil quantity, oil temperature, propeller speed, propeller blade angle, engine torque, and chip detection, are required.

On a conventional twin engine airplane, the engines are sufficiently separated to essentially eliminate the possibility of a fire spreading from one engine to another. In the Model LM 200, the engines are in close proximity, separated only by a ballistic shield and firewall. The fire protection system of the Model LM 200 airplane must include features to isolate each fire zone from any other zone and the airplane in order to maintain isolation of the engines and CGB during a fire. Therefore, these proposed special conditions mandate that the firewall required per § 23.1191 be extended to provide firewall isolation between either engine and the CGB. Furthermore, if the potential for fire exists in the CGB compartment, these special conditions require that enough fire-extinguishing agents be available to supply the CGB compartment and one engine compartment with the CGB on a dedicated system. These proposed special conditions require that heat radiating from a fire originating in any fire zone must not affect components in adjacent compartments in such a way as to endanger the airplane. If the potential for fire does not exist within the CGB compartment, this must be substantiated by analysis.

Each fire zone should be ventilated to prevent the accumulation of flammable vapors. In addition, it must be designed such that it will not allow entry of flammable fluids, vapors, or flames from other fire zones. It should also be designed such that it does not create an additional fire hazard from the discharge vapors.

Propeller control system failures may not be catastrophic in a conventional commuter category airplane; however, these types of failures should be demonstrated as not being catastrophic for the Model LM 200. To ensure a comparable level of safety to conventional commuter category airplanes in the event of a propeller control system failure, these proposed special conditions require that the Model LM 200 propulsion system be designed such that the airplane meets the one-engine-inoperative performance requirements of §§ 23.53, 23.67, 23.69, and 23.75 with the propeller control system failed placing the propeller in the most critical thrust producing condition with both engines operating normally.

In accordance with the exemption to § 23.3(d), the limitations section of the Airplane Flight Manual will limit the airplane to a maximum of nine passengers.

Sections 23.1583, 23.1585 and 23.1587 require pertinent information to be included in the Airplane Flight Manual. These rules are not adequate to address critical propeller failures or propeller control system failures on the Model LM 200 airplane. As a result, these proposed special conditions require that the critical procedures and information required by §§ 23.1583(b), 23.1583(c), 23.1585(a), 23.1585(c) and 23.1587(d) include consideration of these critical propeller failures or propeller control system failures in order to ensure a high level of safety for this airplane.

The Model LM 200 design includes a suction defuel capability not envisaged when part 23 was developed. It is understood that suction defuel is a common feature in part 25 airplanes. The Model LM 200 airplane will have pressure fuel and defuel capability. Pressure defueling essentially entails reversing the pumps on the fueling vehicle and “evacuating” fuel under vacuum from the airplane through the servicing port. Section 23.979 addresses pressure fueling but not suction defueling. In addition to meeting the general requirements for part 23 fuel systems, any suction defueling components must also function as intended.

Each of the engines will be controlled by a fully redundant full authority digital electronic control (FADEC). Each engine will utilize two single channel FADEC's, which yields a total of four to service the PSU. Each FADEC is identical and contains engine and propeller control capability. However, only two of the four units are wired to control the propeller. Cross-FADEC communication provides automatic enabling of the automatic power reserve in case of a single engine failure during takeoff. During normal operation, one FADEC of each engine controls that engine's operation while the second FADEC remains in hot standby mode with the outputs deactivated and waiting to assume control. If the controlling unit fails, the unit in standby mode should instantly assume control of the engine and propeller (if applicable) without noticeable discontinuity.

As the sole means of controlling the engine and the primary means of controlling the propeller on the Model LM 200 airplane, the FADEC installation must comply with the system installation requirements of § 23.1309. While this rule was not developed to address the specifics of a FADEC installation, this requirement is consistent with the rule's intent to cover all complex electronic systems that perform critical functions.

As discussed above, these special conditions are applicable to the Model LM 200. Should Ayres Corporation apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101(a)(1).

A notice of proposed special conditions, Notice No. 23-00-03-SC, for the Ayres Corporation Model LM 200 “Loadmaster” airplane was published on August 14, 2000 (65 FR 49513). Where comments arrived without a recommended change to the special conditions, those comments are not addressed here. It should be noted that the FAA does not assume that the airplane will maintain the same level of operation and certitude as a Commuter Category airplane. Also, non-redundant propulsion systems are addressed separately from the proposed special conditions (an exemption to 14 CFR part 23, § 23.3(d), the multi-engine requirement, was needed).

Comments received with a recommendation have been resolved and the special conditions are adopted with the following revisions:

1. A helicopter engine company suggested we use “twin power section turboprop” instead of “twin power section turboshaft” under the background, the novel or unusual design features, the powerplant definition, the proposed special conditions, and the definitions.

Resolution: Adopted. “Twin power section turboshaft” has been changed to “twin power section turboprop.”

2. The same commenter recommends we revise the definition of “combi” configuration in the background section by adding the phrase “up to nine passengers” to clarify it.

Resolution: Adopted. The comment further clarifies that the LM 200 will be limited by the type certificate to a maximum of nine passengers in any configuration.

3. One commenter recommended that we clarify that the one-hour continue-to-run capability of the combining gearbox is after a failure of the primary lubrication system. A double failure that also fails the emergency lubrication system may not provide this capability. Therefore, the commenter suggests rewording paragraphs (b) and 2(b)(3)(vi).

Resolution: The intent of the special condition was not to address the primary system failures only but single failures of the entire CGB lubrication system. A lubrication system failure that would not affect the ability for continued operation, as with the emergency lubrication system, indicated by the commenter, would meet the requirement. In these special conditions the words “a failure” regard multiple, independent failures and cascading failures. Multiple, independent failures need not be addressed. However, cascading failures resulting from a single failure would still need to be addressed.

The confusion appears to be caused by reference to “primary lubrication system” in section (b) “Powerplant Requirements”. All other discussions refer to it as the “CGB lubrication system”. Therefore, “primary” in section (b) will be replaced with “CGB” for consistency with the rest of the proposed Special Conditions.

4. LHTEC indicated that the entire Part 33 CTP800-4T powerplant, including the combining gearbox (CGB), will undergo a 1500 hour Time to Initial Maintenance Inspection Interval FAA certification test, per 14 CFR part 33, § 33.90. They believe, since the CGB is a component of the FAR 33 powerplant, this test should be used to establish the CGB inspection interval rather than the special condition 200 hour endurance test. Therefore, they recommend revising paragraphs (b) and paragraph 2.

Resolution: Not adopted. As stated on page 49516, Description of Proposed Requirements, paragraph (b), “Current engine certification regulations do not adequately address the requirements of a single combining gearbox; therefore, in addition to the engine requirements of § 23.903, the CGB will be required to complete a 200 hour endurance test that is patterned after the rotor drive system requirements of § 29.923. The endurance test is intended to exercise the integration of the engines, combining gearbox and loading characteristics of the intended propeller.” Therefore, the intent of the special condition is not met with current part 33 standards. However, if the requirements of the special condition are adequately met during engine certification, this data may be used.

5. When the special conditions sections were renumbered from the prior drafts for publication, several section references within the text were not updated to correspond with the new section numbers.

Resolution: Adopted. The paragraphs will be renumbered as recommended.

6. A commenter recommended defining the LHTEC acronym at the beginning of the preamble and the special conditions:

Resolution: Adopted. The acronym will be defined as recommended.

7. A commenter suggested that we add missing word “interval” after “inspection” in paragraph 2(b)(4)(ii):

Resolution: Adopted. The word “interval” will be added.'

8. A commenter requested that we correct the section heading for 2(b)(4)(iii)(c) to change paragraph (c) to a lower case (c):

Resolution: Adopted. Case will be changed to lower “c.”

9. A commenter had the following concerns on issues affecting safety levels in the LM200 design:

For conventional twin engine Joint Aviation Requirements (JAR) 23 commuter airplanes, the probability of a hazardous or catastrophic event resulting from a turbine engine or propeller failure is in the order of 2×10−7 per hour. Accordingly, the reliability of the LM200 Propulsion System Unit (PSU) should maintain this safety target. Also, the JAA's ANPA on the subject of single engine IFR/Night operations contains a target fatal accident rate of 5×10−6.

Resolution: Not adopted. Recommendations made are considerations for compliance with already existing part 23 requirements (i.e., 14 CFR, part 23, § 23.903(c)) or the requirements are already contained in the proposed special conditions and do not require additional requirements.

10. The Civil Aviation Authority notes that under the background there is a statement that the aircraft will be limited to a maximum of nine passengers. It is not clear whether this affects the certification requirements. If the LM200 will be operated as a commuter category aircraft, then the reliability/safety target should be the same as existing commuter airplanes. If the FAA intends something different than this, the commenter believes it should be stated in the FAA Issue Paper.

Resolution: Not adopted. As previously discussed, this is addressed separately from the proposed special conditions (an exemption to 14 CFR, part 23, § 23.3(d), the multi-engine requirement was needed).

11. Also under the background, the same commenter states that the issues to be considered include prevention of single failures resulting in unacceptable levels of unbalance and the capability to continue safe flight to a landing. The background also states that the possibility of catastrophic failure modes should be minimized. The commenter believes that the word minimize is too subjective and would like to have specific safety targets. Acceptable wording could be something along the lines of “the possibility of catastrophic failure modes should be such that the overall catastrophic failure rate will remain equivalent to that of existing commuter airplanes.” Again, if this is not the FAA's intention, this needs to be clarified in the FAA Issue Paper.

Resolution: Not adopted. The intention was not to maintain the same level of safety as the current Commuter Category airplanes but rather to develop requirements for the unique design features of the airplane, per 14 CFR, part 21, § 21.16.

12. The Civil Aviation Authority (CAA) notes that under the type certification basis, in the ‘FAA Position,’ the paper states that engine isolation is a significant requirement with respect to this ‘new’ powerplant configuration. The CAA concurs with the FAA's position that the existing requirements (23.903(c)) are adequate. However as both engines are to be certificated together with the CGB as a single powerplant, the requirement for § 23.903 should be added as a special condition to the powerplant certification basis.

Resolution: Not adopted. The commenter is addressing the engine certification basis/requirements while the proposed special conditions address airplane requirements.

17. The Civil Aviation Authority had some concerns about the definitions of powerplant, engine, propulsion system unit, and multi-engine. They made the following recommendation:

Powerplant—Agree with the definition; do not see the relevance of stating power output.

Engine—Simply state which parts of the powerplant constitute an engine.

Propulsion System Unit—States that the CGB lubrication system is part of the PSU. (Note: As this equipment is fundamental to powerplant reliability, it will need to be represented accurately in the powerplant safety analysis.)

Multi-engine—Term does not need to be defined and its use in this context is misleading. The OEI capability of the powerplant will be defined during certification. It is made clear that “multi-engine” for this configuration does not satisfy the requirement of JAR 23.1(a)(2), this being interpreted as requiring independent propulsion systems. This definition describes the intent to type certificate the powerplant and not the engine. This is a fundamental issue and should not be addressed only under definitions.

Resolution: The changes were not adopted. We believe that the definitions do help with the understanding that the powerplant system and its installation is unique.

18. The CAA asked that the FAA base the failure analysis of the PSU on JAR E510 and JAR P70 as it comprises engines, CGB, and a propeller.

Resolution: Not adopted. We believe that the safety assessment and critical parts control requirements proposed, which are based upon standards currently used by turboshaft engines used in rotorcraft, are sufficient to address the level of certitude needed for this installation.

19. The CAA recommends actions for (1) engine certification requirements and (2) special conditions to address the CGB lubrication system.

Resolution: (1) Not adopted. The proposed special conditions address airplane requirements and not engine certification requirements. (2) Special Conditions are proposed for the CGB lubrication system (i.e., ability to continue flight after a lubrication system failure).

20. The Civil Aviation Authority recommends that the special conditions address the effect of environmental factors, such as bird and lightning strike, to assess the PSU and to demonstrate that the PSU will continue to provide thrust in such an event.

Resolution: Not adopted. There is nothing unique about the installation to require unique considerations of environmental conditions.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability, and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, as delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Ayres Corporation Model LM 200 airplanes.

For purposes of this certification program and subsequent special conditions, the following definitions will apply:

Powerplant—The Light Helicopter Turbine Engine Company (LHTEC) Model CTP800-4T powerplant, consists of two CTS800 derivative turboprop engines, a GKN Westland combining gearbox (CGB), and the engine assembly support structure. The powerplant is capable of providing 2,700 shp combined output power at takeoff and 1,350 shp with one engine inoperative. The CTP800-4T powerplant will obtain a 14 CFR part 33 type certificate identifying the powerplant as a “twin power section turboprop assembly.”

Engine—An LHTEC CTS800 derivative, non-regenerative, front drive, free turbine power section, which includes compressor, combustor, turbine and accessories group. Each engine of the CTP800-4T is separately controlled by a fully redundant full authority digital electronic control (FADEC). The two engines will only be certified as part of the CTP800-4T powerplant. The CTP800-4T type certificate data sheet will include ratings and limitations for each engine in addition to that of the powerplant.

Engine Assembly Support Structure—The supporting structure that connects the two engines to the CGB. This structure will be 14 CFR part 33 certified as part of the CTP800-4T powerplant.

Propulsion System Unit (PSU)—The LHTEC Model CTP800-4T powerplant plus the airframe-mounted non-integrated lubrication system components, which include the CGB oil tank and CGB/engine oil cooler as well as a single Hamilton Sundstrand 568F-11 propeller system.

Combining Gearbox (CGB)—All components necessary to transmit power from the engines to the propeller. This includes couplings, supporting bearings for shafts, brake assemblies, clutches, gearboxes, transmissions, any attached accessory pads or drives, and any cooling fans that are attached to, or mounted on, the gearbox. The CGB will be 14 CFR part 33 certified as part of the CTP800-4T powerplant.

Multi-Engine—For the Model LM 200 and its powerplant configuration, “multi-engine” refers to the twin engine capability and ratings of the CTP800-4T powerplant in regard to type certification in the commuter category and flight operations.

One Engine Inoperative (OEI)—For the Model LM 200 airplane, “one engine inoperative” refers to a condition in which one engine of the CTP800-4T powerplant is not operational and the operation of the propeller is unchanged.

Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for the Ayres Corporation Model LM 200 airplanes.

(a) A PSU System Safety Analysis is required and must identify all hazardous or catastrophic failures associated with the unique design of the PSU. The analysis must consider factors such as lack of redundancy, quality of manufacture and maintenance for continued airworthiness, including consideration of anticipated human errors. Critical procedures must be identified for consideration as required inspection items.

(b) Critical part failures identified in the PSU System Safety Analysis, which result in hazardous or catastrophic events on the airplane, shall be controlled via a Critical Parts Plan. The Critical Parts Plan must be established to ensure that each critical part is designed and then controlled through manufacture and maintained throughout its service life by the following:

(1) Enhanced procurement and manufacturing techniques,

(2) Continued airworthiness requirements,

(3) Conservative life limits.

Additionally, best industry practices shall be utilized in the definition and implementation of these critical parts.

(c) Critical failure modes identified in the PSU System Safety Analysis, which could occur due to the indirect failure of a component or system, should be addressed with appropriate design features to mitigate the potential results of such events.

(d) An appropriate inspection interval and instructions shall be established for any possible latent failure of fail-safe backup components.

(e) All fail-safe designs must be approved by test or analysis under the most adverse operational conditions and failure modes. A means of annunciating failure of the primary system, which could affect the safe operation of the airplane, must be provided to the pilot or maintenance crew.

(a) Vibration.

(1) It must be demonstrated by analysis, test, or combination thereof, that high-energy rotating turbomachinery failures that create high-energy rotor unbalance should not affect the operation of the CGB, the healthy engine by vibration transmitted through the CGB, the integrity of the airframe, powerplant, engine mounts, or the engine assembly support structure and attachments, or prevent continued safe flight and landing.

(2) High-energy fragment and fire shielding and surrounding engine structure and attachments, if attached to the engine, should be included in the rotor dynamics analysis or any test that affects the rotors.

(b) CGB Design, Endurance Testing and Additional Tests.

(1) CGB Design. The CGB must meet the requirements as set forth in paragraphs 2(b)(1)(i) through 2(b)(4).

(i) The CGB must incorporate a device to automatically disengage any engine from the propeller shaft if that engine fails.

(ii) The oil supply for components of the CGB that require continuous lubrication must be sufficiently independent of the lubrication systems of the engine(s) to ensure operation without damage to the CGB, with any engine inoperative. Each independent lubrication system must function properly in the flight attitudes and atmospheric conditions in which an airplane is expected to operate.

(iii) Torque limiting means must be provided on all accessory drives that are located on the CGB in order to prevent the torque limits established for those drives from being exceeded.

(2) CGB Endurance Tests. Each part tested, as prescribed in this section, must be in serviceable condition at the end of the tests. No intervening disassembly that might affect these results may be conducted. An endurance test report explaining the test results and documenting the pre- and post-test wear measurements should be completed.

(i) Endurance tests; general. In addition to the 150-hour powerplant test requirements of § 33.87, the CGB must be tested as prescribed in paragraphs 2(b)(2)(ii) through 2(b)(2)(ix), for at least 200 hours plus the time required to meet paragraph 2(b)(2)(ix). These tests must include the engines as well as the vibration and loading characteristics of the propeller and allowable takeoff imbalance tolerance. For the 200-hour portion, these tests must be conducted as follows:

(A) Twenty each, ten-hour test cycles consisting of the test times and procedures in paragraphs 2(b)(2)(i) through 2(b)(2)(viii); and

(B) The test torque must be determined by actual powerplant limitations.

(ii) Endurance tests; takeoff torque run. The takeoff torque endurance test must be conducted as follows with both engines operating at, or CGB input shafts loaded to, the same conditions:

(A) The takeoff torque run must consist of one hour of alternating runs of five minutes operating at the torque and speed corresponding to takeoff power, and five minutes at as low a powerplant idle speed as practicable. This should be done with no airframe power extractions to produce the highest takeoff torque and lowest idle.

(B) Deceleration and acceleration must be performed at the maximum rate. (This corresponds to a one-second power setting change from idle to takeoff and one second from takeoff to idle setting.) This should also be conducted with no airframe power extractions.

(C) The time duration of all engines at takeoff power settings must total one hour and does not include the time at idle and the time required to go from takeoff to idle and back to takeoff speed.

(iii) Endurance tests; maximum continuous run. Three hours of continuous operation, at the torque corresponding to maximum continuous power and speed, must be conducted with maximum airframe power extractions.

(iv) Endurance tests; 90 percent of maximum continuous run. One hour of continuous operation, at the torque corresponding to 90 percent of maximum continuous power at maximum continuous rotational propeller shaft speed with maximum airframe power extractions.

(v) Endurance tests; 80 percent of maximum continuous run. One hour of continuous operation, at the torque corresponding to 80 percent of maximum continuous power at the minimum rotational propeller shaft speed intended for this power with maximum airframe power extractions.

(vi) Endurance tests; 60 percent of maximum continuous run. Two hours of continuous operation, at the torque corresponding to 60 percent of maximum continuous power at the minimum rotational propeller shaft speed intended for this power with maximum airframe power extractions.

(vii) Endurance tests; engine malfunctioning run. It must be determined whether malfunctioning of components, such as the engine fuel or ignition systems, or unequal engine power distribution can cause dynamic conditions detrimental to the drive system. If so, a suitable number of hours of operation must be accomplished under those conditions, one hour of which must be included in each cycle and the remaining hours of which must be accomplished at the end of 20 cycles. This testing is to be divided between the following four conditions by alternating between cycles: (1) engine #1 “ON”/engine #2 “IDLE”; (2) engine #1“ON”/engine #2 “OFF”; (3) engine #1 “IDLE”/engine #2 “ON”; (4) engine #1 “OFF”/engine #2 “ON”. If no detrimental condition results, an additional hour of operation in compliance with paragraph (B) of this section must be conducted. This will require 100 percent transfer of the airframe air, electrical, and hydraulics to the operating engine within approved Installation Manual limitations.

(viii) Endurance tests; overspeed run. One hour of continuous operation must be conducted at the torque corresponding to maximum continuous power and at 110 percent of rated maximum continuous rotational propeller shaft speed. This should be performed without airframe power extractions for highest speed. If the overspeed is limited to less than 110 percent of maximum continuous speed by the speed and torque limiting devices, the speed used must be the highest speed allowable assuming that speed and torque limiting devices, if any, function properly.

(ix) Endurance tests; one-engine-inoperative application. A total of 160 full differential power applications must be made at takeoff torque and RPM. If, during these tests, it is found that a critical dynamic condition exists, an investigative assessment to determine the cause shall be performed throughout the torque/speed range. In each of the 160 power setting cycles (160 per engine) a full differential power application must be performed. In each cycle, the transition from clutch engagement to disengagement must occur at the critical condition for clutch and shaft wear.

(3) Additional CGB Tests. Following the 200-hour endurance test, and without any intervening major disassembly, additional dynamic, endurance, and operational test and vibratory investigations must be performed to determine that the drive mechanism is safe. The following additional tests and conditions apply:

(i) If the torque output of both engines to the CGB can exceed the highest engine or CGB torque limit, the following tests must be conducted. Under conditions with both engines operating, apply 200 cycles to the CGB for 10 seconds each of an input torque that is at least equal to the lesser of—

(A) The maximum torque used in complying with paragraph 2(b)(3)(ii) plus 10 percent; or

(B) The maximum torque attainable under normal operating conditions, assuming that any torque limiting devices function properly.

(ii) With each engine alternately inoperative, apply the maximum transient torque attainable under normal operating conditions, assuming that any torque limiting devices function properly. Each CGB input must be tested at this maximum torque for at least one hour.

(iii) The CGB must be subjected to 50 overspeed runs, each 30 plus or minus 3 seconds in duration, at a speed of at least 110 percent of maximum continuous speed or other maximum overspeed that is likely to occur plus a margin of speed approved by the Administrator for that overspeed condition. These runs must be conducted as follows:

(A) Overspeed runs must be alternated with stabilizing runs from 1 to 5 minutes duration, each 60 to 80 percent of maximum continuous speed.

(B) Acceleration and deceleration must be accomplished in a period no longer than 10 seconds, and the time for changing speeds may not be deducted from the specified time for the overspeed runs.

(iv) Each part tested, as prescribed in this section, must be in serviceable condition at the end of the tests. No intervening disassembly that might affect test results may be conducted.

(v) If drive shaft couplings are used and shaft misalignment or deflections are probable, loads must be determined in establishing the installation limits affecting misalignment. These loads must be combined to show adequate fatigue life.

(vi) The CGB must be able to continue safe operation, although not necessarily without damage, at a torque and rotational speed prescribed by the applicant that is determined to be the most critical of the anticipated flight conditions for at least one hour after perception by the flight crew of the CGB primary lubrication system failure or loss of lubricant. The demonstrated torque and rotational speed must be included in the instruction manual for installing and operating the engine required in 14 CFR part 33.5.

(4) Fatigue Evaluation. The critical parts of the CGB must be shown by analysis supported by test evidence and, if available, service experience to be of fatigue tolerant design. The fatigue tolerance evaluation must include the requirements of either paragraph (2)(b)(4)(i), (ii), or (iii) of this section, or a combination thereof, and must include a determination of the probable locations and modes of damage caused by fatigue, considering environmental effects, intrinsic/discrete flaws, or accidental damage. Compliance with the flaw tolerance requirements of paragraph (2)(b)(4)(i) or (ii) of this section is required unless the applicant establishes that these fatigue flaw tolerant methods for a particular part cannot be achieved within the limitations of geometry, inspectability, or good design practice. Under these circumstances, the safe-life evaluation of paragraph (iii) of this section is required.

(i) Flaw tolerant safe-life evaluation. It must be shown that the critical part, with flaws present, is able to withstand repeated loads of variable magnitude without detectable flaw growth for the following time intervals—

(A) Life of the airplane; or

(B) Within a replacement time furnished in the Instructions for Continued Airworthiness.

(ii) Fail-safe (residual strength after flaw growth) evaluation. It must be shown that the critical part after a partial failure is able to withstand design limit loads without failure within an inspection interval per the Instructions for Continued Airworthiness. Limit loads are defined in § 23.301(a).

(A) The residual strength evaluation must show that the critical part after flaw growth is able to withstand design limit loads without failure within its operational life.

(B) Inspection intervals and methods must be established as necessary to ensure that failures are detected prior to residual strength conditions being reached.

(C) If significant changes in structural stiffness or geometry, or both, follow from a structural failure or partial failure, the effect on flaw tolerance must be further investigated.

(iii) Safe-life evaluation. It must be shown that the critical part is able to withstand repeated loads of variable magnitude without detectable cracks for the following time intervals—

(A) Life of the airplane; or

(B) Within a replacement time furnished in the Instructions for Continued Airworthiness.

(C) Powerplant and Engine Mounts.

(1) All principal structural elements of the powerplant and engine mount structure that could fail as a result of an uncontained engine failure or resulting fire must be fail-safe as defined in § 23.571(b). All other principal structural elements of the powerplant and engine mount system must either be fail-safe or meet the damage tolerance criteria of § 23.574(a).

(i) For fail-safe design:

(A) The fail-safe structure must be able to withstand the limit loads, considered as ultimate, given in §§ 23.361 and 23.363.

(B) If the occurrence of load-inducing propeller control systems malfunctions is less frequent than 1×10−5 occurrences per flight hour, and if it can be demonstrated that failure or partial failure of a structural element would be obvious, the engine torque loads of § 23.361(a)(3) do not need to be considered in the fail-safe design.

(ii) If damage tolerance evaluation is used,

(A) The residual strength evaluation must consider the limit loads, considered as ultimate, given in §§ 23.361 and 23.363.

(B) If the occurrence of load-inducing propeller control system malfunctions is less frequent than 1×10−5 occurrences per flight hour, the engine torque loads of § 23.362(a)(3) do not need to be considered in the residual strength evaluation.

(a) The applicant must complete a 2,500 airplane cycle evaluation of the propeller installation. A cycle must include the power levels associated with ground idle, takeoff, climb cruise, and descent. This evaluation may be accomplished on the airplane in a combination of ground and flight cycles or on a ground test facility. If the testing is accomplished on a ground test facility, the test configuration must include sufficient interfacing system hardware to simulate the actual airplane installation, including the engines, CGB, and mount system. Each part tested, as prescribed in this section, must be in serviceable condition at the end of the tests. No intervening disassembly, other than normal maintenance (as defined for the installation), that might affect these results may be conducted. A test report explaining the test results and documenting the pre- and post-test condition should be completed.

(b) Propeller Unbalance. It must be shown by a combination of testing and analysis that any single failure or probable combination of failures not deemed a critical part under paragraph 1(b) that could cause an unbalanced propeller condition will not cause damage to the engines, CGB, powerplant mount system, primary airframe structure, or to critical equipment that would jeopardize the continued safe flight and landing of the airplane. Furthermore, the degree of flight deck vibration must not jeopardize the crew's ability to continue to operate the airplane in a safe manner. The magnitude and frequency of the vibration should be included in the installation manual. Any part (or parts) whose failure (or combination of failures) would result in a propeller unbalance greater than the defined maximum should also be classified as critical.

(c) A means must be provided to prevent any adverse effect resulting from rotation of the propeller, in either direction, on the ground.

(a) The propeller control must be independent of the engines such that a failure in either engine or any engine control system will not result in failure to control the propeller.

(b) The propeller control system must be designed to minimize the occurrence of any single failure that would prevent the propulsion system from producing thrust at a level required to meet §§ 23.53(c), 23.67(c), 23.69, 23.75, and 23.77(c).

(c) An uncommanded propeller pitch change must not result in an unsafe condition and an indication of the failure must be annunciated to the flight crew.

(a) Engine Failure Indication. A means must be provided to indicate when an engine is no longer able to provide torque, or to provide stable torque, to the propeller. This means may consist of instrumentation required by other sections of part 23 or these special conditions if it is determined that those instruments will readily alert the flight crew when an engine is no longer able to provide torque, or to provide stable torque, to the propeller. This indicator must preclude confusion by the flight crew in reacting to the failure and when taking appropriate action to secure the airplane in a safe condition for continued flight.

(b) Engine/Propeller Vibration Exceedance Indication. A means must be provided to indicate when the PSU vibration levels exceed the maximum vibration level defined for continuous operation. Procedures to respond to this exceedance should be included in the AFM.

(c) The engine instrumentation requirements of § 23.1305 (a), (c), and (e) shall apply to each engine as defined in these special conditions.

(d) In addition to the requirements of § 23.1305, the following instruments must be provided:

(1) An oil pressure warning means and indicator for the pressure-lubricated CGB to indicate when the oil pressure falls below a safe value.

(2) A low oil quantity indicator for the CGB, if lubricant is self-contained;

(3) An oil temperature warning device to indicate unsafe CGB temperatures;

(4) A tachometer for the propeller;

(5) A propeller pitch control failure indication;

(6) A torquemeter for each engine if the sum of the maximum torque that each engine is capable of producing exceeds the maximum torque for which the CGB has been certified under 14 CFR part 33; and

(7) A chip detecting and indicating system for the CGB.

(a) Each engine must be isolated from the other engine and CGB by firewalls, shrouds or equivalent means. Each firewall or shroud, including applicable portions of the engine couplings, must be constructed such that no hazardous quantity of liquid, gas, or flame can pass between the isolated fire zone of each engine or the CGB compartment.

(b) In addition to the engine fire zones, if the potential for fire exists in the CGB compartment, then the CGB must be in a separate fire zone and must comply with all fire protection requirements of 14 CFR part 23. Enough fire-extinguishing agent will be required for the CGB compartment and at least one engine compartment. A dedicated fire extinguishing system will be required for the CGB compartment. If the potential for fire does not exist within the CGB compartment, this must be substantiated by analysis.

(c) Firewall temperatures under all normal or failure conditions must not result in auto-ignition of flammable fluids and vapors present in the other engine compartment and the CGB compartment.

(d) The CGB compartment ventilation system must be designed such that:

(1) It is ventilated to prevent the accumulation of flammable vapors.

(2) No ventilation opening may be where it would allow the entry of flammable fluids, vapors or flame from other zones.

(3) Each ventilation means must be arranged so that no discharged vapors will cause an additional fire hazard.

(4) Unless the extinguishing agent capacity and rate of discharge are based on maximum airflow through the compartment, there must be a means to allow the crew to shut off sources of forced ventilation.

(a) Flight tests must demonstrate means to exclude hazardous quantities of smoke, flames or extinguishing agent from any compartment occupied by the crew or passengers.

(b) Cargo compartments shall have either fire or smoke detection provisions, or both, unless the compartment location is such that a fire can be easily detected by the pilots seated at their duty station. The cargo and baggage fire protection must be in accordance with § 23.855 as well as the following:

(1) The detection system must provide a visual indication to the flight crew within one minute after the start of a fire.

(2) The system must be capable of detecting a fire at a temperature significantly below that at which the structural integrity of the airplane is substantially decreased.

(3) There must be means to allow the crew to check the functioning of each fire detector circuit while in flight.

(4) The detection system effectiveness must be shown for all approved operating configurations and conditions.

(c) The flight crew must have means to shut off the ventilating airflow to, or within, the compartment from the pilot's station on the all-cargo configuration.

(d) Passenger and combi configurations, where the cargo compartment is not accessible to the flight crew, must have an approved built-in fire extinguishing system. The built-in fire extinguishing system shall be controllable from the pilots' station. There must be means to control ventilation and drafts within the inaccessible cargo compartment so that the extinguishing agent can control any fire that may start within the compartment. The built-in fire extinguisher must be installed so that no extinguishing agent likely to enter personnel compartments will be hazardous to the occupants. The discharge of the extinguisher must not cause structural damage. The capacity of the extinguishing system must be adequate for any fire likely to occur in the compartment where used. Consideration must be given to the volume of the compartment and the ventilation rate.

(e) In addition to the hand fire extinguishers required by § 23.851, a hand fire extinguisher must be readily accessible for use in each cargo or baggage compartment that is accessible to crewmembers in flight. Hazardous quantities of smoke, flames or extinguishing agent must not enter any compartment occupied by the crew or passengers when the access to that compartment is used.

(f) Protective breathing equipment must be installed for crewmembers in each crewmember compartment. Protective breathing equipment must:

(1) Be designed to protect the flight crew from smoke, carbon dioxide, and other harmful gases at the pilot's station and while combating fires in cargo compartments.

(2) Have masks that cover the eyes, nose, and mouth; or masks that cover the nose and mouth plus accessory equipment to cover the eyes.

(3) Allow the flight crew to use the radio equipment and to communicate with each other while at their assigned stations.

(4) Not cause any appreciable adverse effect on vision and must allow corrective glasses to be worn.

(5) Supply protective oxygen of 15 minutes duration per crewmember at a pressure altitude of 8,000 feet with a respiratory minute volume of 30 liters per minute BTPD. If a demand oxygen system is used, a supply of 300 liters of free oxygen at 70° F and 760 mm. Hg. pressure is considered to be of 15 minute duration at the prescribed altitude and minute volume. If a continuous flow protective breathing system is used (including a mask with a standard rebreather bag) a flow rate of 60 liters per minute at 8,000 feet (45 liters per minute at sea level) and a supply of 600 liters of free oxygen at 70° F and 760 mm. Hg. pressure is considered to be of 15 minute duration at the prescribed altitude and minute volume. BTPD refers to body temperature conditions (that is, 37° C, at ambient pressure, dry).

(6) Be free from hazards in itself, in its method of operation, and in its effect upon other components.

(7) Have a means to allow the crew to readily determine, during flight, the quantity of oxygen available in each source of supply.

(a) In addition to the takeoff performance requirements of § 23.53(c), the same requirements must be met with both engines operating normally and the propeller primary control system failed in the most critical thrust producing condition at VEF and above, considering all single point failures.

(b) In addition to the one engine inoperative climb requirements of § 23.67(c), the same requirements must be met with both engines operating normally and the propeller primary control system failed in the most critical thrust producing condition, considering all single point failures.

(c) In addition to the requirements of § 23.69, the steady gradient and rate of climb/descent must be determined at each weight, altitude, and ambient temperature within the operational limits established by the applicant with both engines operating normally and the propeller primary control system failed in the most critical thrust producing condition, considering all single point failures.

(d) In addition to § 23.75, the horizontal distance necessary to land and come to a complete stop from a point 50 feet above the landing surface must be determined as required in § 23.75 with both engines operating normally and the propeller primary control system failed in the most critical thrust producing conditions, considering all single point failures.

(e) The balked landing requirements of § 23.77(c) must be performed with the propeller primary control system failed in the most critical thrust producing condition, considering all single point failures.

(a) In addition to the requirements of §§ 23.1583(b) and 23.1585(a), a pre-flight visual inspection of the propeller components must be included in the Airplane Flight Manual.

(b) In addition to the requirements of § 23.1585(c), procedures for maintaining or recovering control of the airplane in all conditions identified in section 8 of these special conditions must be included in the Airplane Flight Manual.

(c) The information required by § 23.1583(c)(4) and § 23.1587(d) must be furnished with the propeller control system failed or with one engine inoperative, whichever is more critical.

(a) The airplane defueling system (not including fuel tanks and fuel tank vents) must withstand an ultimate load that is 2.0 times the load arising from maximum permissible defueling pressure (positive or negative) at the airplane fueling connection.

(a) The installation of the electronic engine/propeller control (FADEC control system) must comply with the requirements of § 23.1309 (a) through (e).

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the approval design and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

Interested persons are invited to submit such written data, views, or arguments as they may desire. Communications should identify the regulatory docket or notice number and be submitted in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE170.” The postcard will be date stamped and returned to the commenter.

On December 18, 2000, Byerly Aviation Inc., Greater Peoria Airport., 6100 Everitt M Dirksen Parkway, Peoria, Illinois 61607, made an application to the FAA for a new Supplemental Type Certificate for Twin Commander model series 690/695 airplanes. The Twin Commander model series 690/695 airplanes are currently approved under TC No. 2A4. The proposed modification incorporates a novel or unusual design feature, such as digital avionics consisting of an EFIS, that is vulnerable to HIRF external to the airplane.

Under the provisions of 14 CFR part 21, § 21.101, Byerly Aviation, Inc. must show that their modification to Twin Commander model 690, 690A, 690B, 690C, 690D, 695, 695A, & 695B aircraft meets the applicable portions of the Certification Basis for each respective model as shown on Type Certificate data sheet Number 2A4, and § 23.1301 of Amendment 23-20; §§ 23.1309, 23.1311, and 23.1321 of Amendment 23-49; and § 23.1322 of Amendment 23-43; exemptions, if any; and the special conditions adopted by this rulemaking action.

If the Administrator finds that the applicable airworthiness standards do not contain adequate or appropriate safety standards because of novel or unusual design features of an airplane, special conditions are prescribed under the provisions of § 21.16.

Special conditions are normally issued in accordance with § 11.38, and become a part of the type certification basis in accordance with § 21.101(d).

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.

Byerly Aviation Inc. plans to incorporate certain novel and unusual design features into an airplane for which the airworthiness standards do not contain adequate or appropriate safety standards for protection from the effects of HIRF. These features include EFIS, which are susceptible to the HIRF environment, that were not envisaged by the existing regulations for this type of airplane.

Protection of Systems from High Intensity Radiated Fields (HIRF): Recent advances in technology have given rise to the application in aircraft designs of advanced electrical and electronic systems that perform functions required for continued safe flight and landing. Due to the use of sensitive solid state advanced components in analog and digital electronics circuits, these advanced systems are readily responsive to the transient effects of induced electrical current and voltage caused by the HIRF. The HIRF can degrade electronic systems performance by damaging components or upsetting system functions.

Furthermore, the HIRF environment has undergone a transformation that was not foreseen when the current requirements were developed. Higher energy levels are radiated from transmitters that are used for radar, radio, and television. Also, the number of transmitters has increased significantly. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling to cockpit-installed equipment through the cockpit window apertures is undefined.

The combined effect of the technological advances in airplane design and the changing environment has resulted in an increased level of vulnerability of electrical and electronic systems required for the continued safe flight and landing of the airplane. Effective measures against the effects of exposure to HIRF must be provided by the design and installation of these systems. The accepted maximum energy levels in which civilian airplane system installations must be capable of operating safely are based on surveys and analysis of existing radio frequency emitters. These special conditions require that the airplane be evaluated under these energy levels for the protection of the electronic system and its associated wiring harness. These external threat levels, which are lower than previous required values, are believed to represent the worst case to which an airplane would be exposed in the operating environment.

These special conditions require qualification of systems that perform critical functions, as installed in aircraft, to the defined HIRF environment in paragraph 1 or, as an option to a fixed value using laboratory tests, in paragraph 2, as follows:

(1) The applicant may demonstrate that the operation and operational capability of the installed electrical and electronic systems that perform critical functions are not adversely affected when the aircraft is exposed to the HIRF environment defined in the following table:

(2) The applicant may demonstrate by a system test and analysis that the electrical and electronic systems that perform critical functions can withstand a minimum threat of 100 volts rms per meter, electrical field strength, from 10 kHz to 18 GHz. When using this test to show compliance with the HIRF requirements, no credit is given for signal attenuation due to installation.

A preliminary hazard analysis must be performed by the applicant, for approval by the FAA, to identify either electrical or electronic systems that perform critical functions. The term “critical” means those functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. The systems identified by the hazard analysis that perform critical functions are candidates for the application of HIRF requirements. A system may perform both critical and non-critical functions. Primary electronic flight display systems, and their associated components, perform critical functions such as attitude, altitude, and airspeed indication. The HIRF requirements apply only to critical functions.

Compliance with HIRF requirements may be demonstrated by tests, analysis, models, similarity with existing systems, or any combination of these. Service experience alone is not acceptable since normal flight operations may not include an exposure to the HIRF environment. Reliance on a system with similar design features for redundancy as a means of protection against the effects of external HIRF is generally insufficient since all elements of a redundant system are likely to be exposed to the fields concurrently.

As discussed above, these special conditions are applicable to Twin Commander 690, 690A, 690B, 690C, 690D, 695, 695A, & 695B airplanes. Should Byerly Aviation, Inc. apply at a later date for a supplemental type certificate to modify any other model on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Twin Commander model 690, 690A, 690B, 690C, 690D, 695, 695A, and 695B airplanes modified by Byerly Aviation, Inc. to add an EFIS.

1. Protection of Electrical and Electronic Systems from High Intensity Radiated Fields (HIRF). Each system that performs critical functions must be designed and installed to ensure that the operations, and operational capabilities of these systems to perform critical functions, are not adversely affected when the airplane is exposed to high intensity radiated electromagnetic fields external to the airplane.

2. For the purpose of these special conditions, the following definition applies:

Critical Functions: Functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description on each SIAP is contained in the appropriate FAA Form 8260 and the National Flight Data Center (FDC)/Permanent (P) Notices to Airmen (NOTAM) which are incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation's Regulations (FAR). Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction of charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes SIAPs. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained in the content of the following FDC/P NOTAMs for each SIAP. The SIAP information in some previously designated FDC/Temporary (FDC/T) NOTAMs is of such duration as to be permanent. With conversion to FDC/P NOTAMs, the respective FDC/T NOTAMs have been canceled.

The FDC/P NOTAMs for the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs by FDC/P NOTAMs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a National Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Further, the SIAPs contained in this amendment are based on the criteria contained in the TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expansive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendments may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may require making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a“significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

In the Federal Register of September 8, 2000 (65 FR 54686), FDA published an interim final rule authorizing the use, on food labels and in food labeling, of a health claim on the relationship between plant sterol/stanol esters and reduced risk of CHD (the interim final rule). In the interim final rule, FDA specified requirements for a health claim about the relationship, including types of food eligible to bear the claim, sources and nature of the plant sterol/stanol esters that are the subjects of the claim, daily intakes of these substances needed to reduce the risk of CHD, and analytical methods for assessing compliance with qualifying criteria for the claim. The 75-day comment period closed on November 22, 2000.

After the comment period closed, FDA received comments from two companies, Unilever United States, Inc., and Raisio Benecol Ltd., which included requests for an extension of the comment period. Both comments requested more time for submission of data comparing the daily intake levels of plant sterol esters and plant stanol esters that are effective in reducing the risk of CHD. Because FDA cannot extend a comment period that has closed, the agency considers these as requests to reopen the comment period.

Among the other comments received in response to the interim final rule were requests to expand the types of substances eligible for the health claim to include unesterified plant sterols/stanols and mixtures of plant sterols and plant stanols. We also received a comment advocating the use of serum apolipoprotein B level as a surrogate measure of CHD risk.

Furthermore, in the past year, both the European Commission (EC) and the Australia New Zealand Food Standards Council (ANZFSC) have taken regulatory actions limiting food use of plant sterol esters and requiring advisory labeling statements on foods to which plant sterol esters have been added. Also, a recent publication from the American Heart Association (AHA) (Ref. 1) raised a concern about daily ingestion of plant sterol/stanol ester-containing foods among certain individuals who have abnormally high absorption of plant sterols.

FDA believes that the issues raised by comments and recent events are significant and that thorough evaluation is needed before a final rule is issued. Accordingly, the agency is reopening the comment period for this rulemaking. Given the very tight timeframes that are established by the health claim provisions of the statute, however (see section 403(r)(4)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(i))), as well as the agency's interest in ensuring that scientifically valid claims are authorized as quickly as possible, the agency cautions that only on rare occasions might FDA be in a position to reopen the comment period in a health claim rulemaking. In this case, we believe that reopening the comment period to obtain public input on the new issues is important to help us make more informed decisions in the final rule. Although the statutory deadline for this final rule has passed, FDA intends to move as expeditiously as possible to complete this rulemaking.

In the interim final rule, FDA did not include unesterified plant sterols and plant stanols in the definition of substances eligible for the health claim. Several comments requested that the agency allow foods containing the unesterified form of these substances to bear the health claim. While some of the data in support of the interim final rule were from studies involving unesterified plant sterols or plant stanols, the agency requests submission of any additional data on the effectiveness, particularly at lower intake levels, of the unesterified forms in reducing the risk of CHD. FDA also requests data on the effects of various food matrices on the relationship of unesterified plant sterols/stanols and CHD risk.

In the interim final rule, FDA required health claims for plant sterol/stanol esters to specify the daily intake necessary to reduce the risk of CHD. The agency set different daily intake levels for plant sterol esters and plant stanol esters (1.3 grams/day (g/d) and 3.4 g/d, respectively), based on studies that showed differences in the levels of intake that were effective in reducing low-density lipoprotein (LDL) and blood total cholesterol levels. Many comments argued that one of the daily intake levels should be changed; several comments argued that the daily intake levels for plant sterol esters and plant stanol esters should be the same. FDA requests further comment on these issues, including supporting data on the daily intake levels of plant sterols and plant stanols (in either esterified or unesterified form) that are effective in reducing the risk of CHD.

In the interim final rule, FDA authorized separate health claims for plant sterol esters and plant stanol esters. One comment requested that FDA include mixtures of plant sterols and stanols in the definition of substances eligible to bear the health claim. FDA requests data on the daily intake levels of mixtures of plant sterol esters and plant stanol esters (or mixtures of the unesterified forms) that are effective in lowering CHD risk. If plant sterols and plant stanols (in either esterified or unesterified form) are not equally beneficial at the same levels of intake in reducing CHD risk (as evidenced by validated surrogate markers), FDA also requests data on the relative amounts of plant sterols and plant stanols (in either esterified or unesterified form) in the mixtures that should qualify a food to bear the health claim.

One comment seeking a lower daily effective intake level for plant stanol esters, argued that plasma apolipoprotein B level is a reliable marker of LDL cholesterol that can be measured precisely and directly, in contrast to serum LDL cholesterol level, which usually is determined indirectly by calculation. The comment further argued that plasma apolipoprotein B level is a reliable marker in evaluating the risk of cardiovascular disease. These comments were discussed in relation to the study by Hallikainen et al. (Ref. 2). In the Hallikainen et al. study, the lowest intake of plant stanol esters that reduced serum LDL cholesterol was greater than the intake that reduced serum apolipoprotein B. Thus, the comment asserted these results support a lower daily effective intake level for plant stanol esters than that established in the interim final rule.

FDA requests comment on use of serum apolipoprotein B as a validated surrogate marker for CHD and on the relative utilities of apolipoprotein B and LDL cholesterol in predicting CHD risk.

Since the issuance of the plant sterol/stanol esters interim final rule, FDA has become aware of pertinent regulations from other countries. The EC issued a regulation that requires the label of foods to which plant sterol esters have been added to include certain statements (Ref. 3). Such statements include: (1) The product is for people who want to lower their blood cholesterol levels; (2) patients on cholesterol lowering medication should consume the product only under medical supervision; (3) the product may not be appropriate nutritionally for certain segments of the population (pregnant and breast-feeding women, and children under the age of 5 years); and (4) the product should be used as part of a healthy diet, including regular consumption of fruit and vegetables. The EC explained that statements (3) and (4) were necessary to protect populations at risk (people whose vitamin A status was not optimal) since these products may cause a reduction in plasma beta-carotene (Ref. 3).

The ANZFSC adopted the standard, recommended by the Australia New Zealand Food Authority (Ref. 4), that plant sterol esters should be allowed for use only in edible oil spreads, and that the product must carry an advisory label statement. The advisory label statement informs consumers that plant sterol ester-enriched edible oil spreads are not appropriate for infants, children and pregnant and lactating women, and that people using cholesterol-reducing medication should seek medical advice before using the spreads.

The AHA (Ref. 1) recently published a statement for healthcare professionals on foods containing plant sterol/stanol esters. One of the issues that the AHA raised concerned individuals who have unusually high intestinal absorption of plant sterols. Plant sterols are poorly absorbed by the human intestine, but individuals who are homozygous for a rare genetic disease, sitosterolemia (also known as phytosterolemia), are high absorbers of plant sterols, resulting in tendon and subcutaneous xanthomas (skin lipid deposits). It is not known if individuals heterozygous for this condition absorb higher amounts of plant sterols than the normal population or if this would lead to adverse effects. In the absence of more data on the genetic mutation involved in sitosterolemia, the AHA recommends that individuals with this condition not use foods containing plant sterols/stanols.

Section 201(n) of the the act (21 U.S.C. 321(n)) states that, in determining whether labeling is misleading, the agency shall take into account not only representations made about the product, but also the extent to which the labeling fails to reveal facts material in light of such representations or material with respect to consequences that may result from use of the product. The omission of material facts from the labeling of a food causes the product to be misbranded within the meaning of sections 201(n) and 403(a)(1) of the act. FDA may require disclosure of material facts in labeling by rulemaking or by direct enforcement action (see 21 CFR 1.21).

In light of the issues raised by recent regulatory actions of other countries and by the AHA statement (i.e., whether foods containing plant sterol esters should be used under medical supervision, the appropriateness of consumption of such foods by some subpopulation groups, negative effect of such foods on plasma beta-carotene, and concerns about potential hyper-absorption of plant sterols by some individuals), FDA is considering whether changes to the health claim regulation (§ 101.83 (21 CFR 101.83)), advisory labeling, or other actions are needed to ensure the safe use of plant sterols and stanols (esterified or unesterified) in foods. The agency requests comment on whether the concerns summarized above are material facts and what action, if any, the agency should take to address them. Depending on the comments received and FDA's own evaluation of relevant data, the agency may consider issuing a proposal to amend § 101.83 or initiating a separate rulemaking, as appropriate.

Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments by November 19, 2001. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The interim final rule and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “* * * a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *” and “rules and regulations consistent with regulations issued by the Secretary” pursuant to the Act. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Maryland program on February 18, 1982. You can find background information on the Maryland program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the February 18, 1982, Federal Register (47 FR 7214). You can find subsequent actions concerning the conditions of approval and program amendments at 30 CFR 920.15 and 920.16.

By an undated letter received by OSM on May 7, 2001 (Administrative Record No. 578-12), Maryland submitted a copy of House Bill 984 as a formal proposed amendment to its program. The House Bill was enacted to require members of the Land Reclamation Committee to file a United States Department of Interior State Employee Statement of Employment and Financial Interests. Maryland submitted the formal amendment to satisfy a required amendment at 30 CFR 920.16(l). We announced the proposed amendment in the June 12, 2001, Federal Register (66 FR 31571), and in the same document opened the public comment period and provided an opportunity for a public hearing on the adequacy of the proposed amendment. The public comment period closed on July 12, 2001. We did not receive any public comments. No one requested an opportunity to speak at a public hearing, so no hearing was held.

Set forth below, pursuant to SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, are the Director's findings concerning the amendments to the Maryland permanent regulatory program.

Maryland is adding new paragraph 4. to Section 15-204 of the Annotated Code of the Public General Laws of Maryland, Environment, as follows:

(4) Members of the Land Reclamation Committee shall file a United States Department of Interior State Employee Statement of Employment and Financial Interests.

As a result of this addition, existing paragraph (4) is re-numbered as paragraph (5).

We find that the revision is no less effective than the Federal regulations at 30 CFR 705.11(a) and 705.17(a).

On May 10, 2001, we asked for comments from various Federal agencies who may have an interest in the Maryland amendment (Administrative Record Number MD-578-13). We solicited comments in accordance with section 503(b) of SMCRA and 30 CFR 732.17(h)(11)(i) of the Federal regulations. No responses were received.

Pursuant to 30 CFR 732.17(h)(11)(ii), OSM is required to obtain the written concurrence of the EPA with respect to those provisions of the proposed program amendment that relate to air or water quality standards promulgated under the authority of the Clean Water Act (33 U.S.C. 1251 et seq.) or the Clean Air Act (42 U.S.C. 7401 et seq.). The Director has determined that this amendment contains no such provisions and that EPA concurrence is therefore unnecessary. Therefore OSM did not request EPA's concurrence.

No comments were received in response to our request for public comments.

Based on the findings above we are approving the amendments to the Maryland program. We are also removing the required amendment at 30 CFR 920.16(l). We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. Maryland's program regarding this action is now consistent with the intent of the Federal regulations. Consistency of State and Federal standards is required by SMCRA.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule does not have federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments since each such program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed State regulatory program provision does not constitute a major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3507 et seq.).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-300985A. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In this final rule, EPA is revoking the FFDCA tolerances for residues of the organophosphate pesticides fenthion, methidathion, naled, phorate, and profenofos in or on 67 specific meat, milk, poultry, and egg (MMPE) commodities.

EPA is revoking these 67 tolerances because they are not necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. Based on feeding studies submitted since the time that the tolerances were originally established, the Agency had concluded that there is no reasonable expectation of finite residues in or on meat, milk, poultry, and egg commodities associated with those tolerances for fenthion, methidathion, naled, phorate, and profenofos. These feeding studies used exaggerated amounts of the compound (10x the dietary burden) and did not show measurable residues of the pesticides tested. Because there is no reasonable expectation of finite residues, these 67 tolerances are not required under the FFDCA and can be revoked. The Agency originally made the determination that there is no reasonable expectation of finite residues of fenthion, methidathion, naled, phorate, or profenofos for the 67 commodities listed below on July 11, 1999. EPA published a notice in the Federal Register on August 2, 1999 (64 FR 41933) (FRL-6097-3) that these 67 tolerances were considered as reassessed and have already been counted toward meeting the tolerance reassessment requirements listed in FFDCA section 408(q).

EPA is not issuing today a final rule to revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed above if: (1) Prior to EPA's issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained, (2) EPA independently verifies that the tolerance is no longer needed, or (3) the tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.

In the Federal Register of March 31, 2000 (65 FR 17236) (FRL-6497-7), EPA issued a proposed rule to revoke the tolerances listed in this final rule. Also, the March 31, 2000 proposal invited public comment. In response to the document published in the Federal Register of March 31, 2000, no comments were received by the Agency.

1. Fenthion. EPA is revoking the tolerances in 40 CFR 180.214(a) for residues of fenthion and its cholinesterase-inhibiting metabolites in or on poultry, fat; poultry, meat byproducts (mbyp); and poultry, meat. In 40 CFR 180.214(a), EPA is also removing the “(N)” designation from all entries to conform to current Agency administrative practice (“N” designation means negligible residues).

2. Methidathion. EPA is revoking the tolerances for residues of methidathion and its metabolites in or on cattle, fat; cattle, mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, meat; milk; and eggs by removing 40 CFR 180.298(a)(2) in its entirety. In 40 CFR 180.298, EPA is also redesignating paragraph (a)(1) as paragraph (a) and removing the “(N)” designation from all entries in the table under newly designated paragraph (a) to conform to current Agency administrative practice (“N” designation means negligible residues).

3. Naled. EPA is revoking the tolerances in 40 CFR 180.215(a)(1) for residues of naled and its conversion product 2,2-dichlorovinyl dimethyl phosphate in or on cattle, fat; cattle, mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, meat; milk; and eggs.

4. Phorate. EPA is revoking the tolerances in 40 CFR 180.206(a) for combined residues of phorate and its cholinesterase-inhibiting metabolites in or on cattle, fat; cattle, mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, meat; milk; and eggs.

5. Profenofos. Since the proposed rule, § 180.404 was revised and paragraphs (a), (b), (c), and (d) were designated on May 24, 2000 (65 FR 33691) (FRL-6043-1). EPA is revoking the tolerances in 40 CFR 180.404(a) for combined residues of profenofos and its metabolites converted to 4-bromo-2-chlorophenyl in or on poultry, fat; poultry, mbyp; poultry, meat; and eggs.

When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, the Agency gives consideration to possible pesticide residues in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticide residues (40 CFR 180.6). If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, then tolerances do not need to be established for these commodities (40 CFR 180.6(b) and 180.6(c)).

These actions become effective 90 days following publication of this final rule in the Federal Register. EPA has delayed the effectiveness of these revocations for 90 days following publication of a final rule to ensure that all affected parties receive notice of EPA's actions. Consequently, the effective date is January 3, 2002. For this particular final rule, the actions will affect uses which have been canceled for more than a year.

By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. EPA is also required to assess the remaining tolerances by August 2006. As of September 25, 2001, EPA has reassessed over 3,780 tolerances. In this document, EPA is revoking 67 tolerances and/or exemptions; however, since all were previously counted as reassessed, none are counted here toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Documents (REDs). EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/. On the Home Page select “Laws and Regulations,” then select “Regulations and Proposed Rules” and then look up the entry for this document under Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-300985A in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before December 4, 2001.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Objection/hearing fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-300985A, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule will revoke tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action; i.e., a tolerance revocation for which extraordinary circumstances do not exist, from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, I certify that this action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis.

In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the pre-exemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175 requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

Because we received comments that oppose this authorization, we are withdrawing the immediate final rule for Idaho: Final Authorization of State Hazardous Waste Management Program Revisions published on August 22, 2001, at 66 FR 44071, which intended to grant authorization for the revisions to Idaho's Hazardous Waste Regulations. We stated in the immediate final rule that if we received comments that opposed this action, we would publish a timely notice of withdrawal in the Federal Register. We received comments that opposed this action. We will address all comments in a subsequent final action based on the proposed rule previously published on August 22, 2001, at 66 FR 44107, and will not provide for additional public comment during the final action.

1. By this order, we amend 0.231(e) of the Commission's rules, 47 CFR 0.231(e), to reflect the change of Board of Contract Appeals to which contract appeals shall be referred. The Managing Director will refer all appeals of final decisions regarding procurement contracts to the Armed Services Board of Contract Appeals.

2. Accordingly, pursuant to § 0.231(b) of the Commission's rules, 47 CFR 0.231(b), § 0.231(e) of the Commission's rules, 47 CFR 0.231(e), is Amended as rule changes and is effective October 1, 2001.

This is a summary of the Commission's First Report and Order in ET Docket No. 00-47, FCC 01-264, adopted September 13, 2001, and released September 14, 2001. The full text of this Commission decision is available on the Commission's Internet site at www.fcc.gov. It is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW., Washington, DC, and also may be purchased from the Commission's duplication contractor, Qualex International (202) 863-2893, Room CY-B402, 445 12th Street, S.W. Washington, D.C. 20554.

1. In this First Report and Order (FR&O), the Commission amends part 2 of its rules to create a new class of equipment for software defined radios (SDRs) with streamlined equipment authorization procedures. We anticipate that software defined radio technology will allow manufacturers to develop reconfigurable transmitters or transceivers that can be multi-service, multi-standard, multi-mode, and multi-band. Specifically, we are amending our equipment authorization rules to permit equipment manufacturers to make changes in the frequency, power and modulation parameters of such radios without the need to file a new equipment authorization application with the Commission. We will also permit electronic labeling so that a third party may modify a radio's technical parameters without having to return it to the manufacturer for re-labeling. These changes will facilitate the deployment and use of this promising new technology, which we believe will facilitate more efficient use of the spectrum.

2. In March 2000, the Commission issued a Notice of Inquiry, 65 FR 17246, March 31, 2000, seeking information from the public on a number of issues raised by the development of software defined radios. Subsequently, in December 2000, the Commission issued a Notice of Proposed Rule Making (NPRM), 66 FR 341, January 3, 2001, that proposed to define software defined radios as a new class of equipment and to simplify the authorization requirements for such equipment.

3. Upon reviewing the record, we conclude that it is desirable to revise our equipment authorization rules to accommodate the flexibility offered by software defined radios. The ability of software defined radios to be reprogrammed to new operating parameters in the field could have far reaching implications for the way the Commission allocates and licenses spectrum and authorizes radio equipment. Software defined radios could allow more efficient use of spectrum by facilitating spectrum sharing and by allowing equipment to be reprogrammed to more efficient modulation types. Their ability to be programmed could also enhance interoperability between different radio services. We find that it is possible to provide this flexibility in a manner that will ensure that software defined radios operate in compliance with the rules for the service in which they will operate. We therefore are adopting a definition of software defined radio and a streamlined procedure for making changes to the operating parameters of software defined radios. We are also adopting rules to permit electronic labeling of software defined radios and to require manufacturers to take steps to prevent unauthorized software modifications. These changes will provide greater flexibility to manufacturers to facilitate the deployment of software defined radios while fulfilling our statutory requirement to protect the public from harmful interference. We will consider additional rule changes in the future as software defined radio technology advances.

4. The NPRM proposed to define a software defined radio, for regulatory purposes, as “* * * a radio that includes a transmitter in which the operating parameters of the transmitter, including the frequency range, modulation type or maximum radiated or conducted output power can be altered by making a change in software without making any hardware changes.” We indicated that this definition was not intended to cover devices that use software simply to control functions such as power or frequency within a range approved by the Commission. Receivers would not be covered under this definition.

5. Based on the comments received, we are adopting the following regulatory definition for software defined radio that requires that at least one of the three operating parameters of frequency, modulation type or output power be software programmable. Our purpose in adopting this expansive definition of software defined radio is to foster development of this promising technology and to enable manufacturers to take advantage of the streamlined equipment authorization process, if they so desire.

Software Defined Radio. A radio that includes a transmitter in which the operating parameters of frequency range, modulation type or maximum output power (either radiated or conducted) can be altered by making a change in software without making any changes to hardware components that affect the radio frequency emissions.

6. The rules currently require most radio transmitters to be approved by the Commission or a designated Telecommunication Certification Body (TCB) before they may be marketed. When changes are made to the operating frequencies, output power, or types of radio frequency emissions of an authorized transmitter, the grantee is required to apply for a new approval and wait until the approval is issued before the equipment may be marketed with the changes.

7. The rules allow two classes of “permissive changes” for authorized equipment without requiring a new approval. Class I permissive changes include modifications that do not degrade the RF emissions from a device at the time of initial certification and do not require any filing with the Commission. Class II permissive changes include modifications other than frequency, modulation or power that degrade the RF emissions from a device reported at the time of the initial certification. Class II changes are authorized through a streamlined filing procedure that does not require the filing of a complete application form with all exhibits normally required for a new approval. Instead, the applicant simply files a description of the changes and measurement results showing the changed equipment continues to comply with the rules.

8. The transmitter authorization rules were developed at a time when transmitters were hardware based. At that time, changes to the frequency, modulation type, and power output of a transmitter were performed by making changes to the layout and physical components of electronic circuits. Such changes essentially resulted in a new device, so we required a complete new application form with all exhibits and required a new identification number on the device. However, in a software defined radio, changes to these operating parameters can be accomplished through a software change with no change in hardware. Requiring manufacturers to obtain a new approval for equipment when changes are made only to the software is unnecessarily burdensome because a new identification number must be used and the equipment already in the field may have to be recalled for re-labeling by the manufacturer. Therefore, we proposed in the NPRM to develop a more streamlined authorization procedure for changes to the operating parameters of software defined radios.

9. We proposed that any changes in frequency, power, or modulation type of a software defined radio may be authorized as a new class of permissive change, which we proposed to designate as Class III. This would streamline the filing procedure for changes to approved software defined radios and would eliminate the need for a new identification number. We also proposed to require that the applicant for a Class III change submit test data showing that the equipment complies with the applicable requirements for the service(s) or rule parts under which the equipment will operate with the new software. The applicant would have to demonstrate compliance with the applicable RF exposure requirements. The Commission would notify the applicant when a permissive change is granted. Once a Class III permissive change was granted for a software defined radio with changes that affect the operating parameters, the new software could be loaded into units in the field. The record in the Commission's database for each authorized device would be amended to show the approved frequency range(s), power and modulation type(s) as it does now. Additional frequency ranges or other new technical parameters would be added to the database record for an authorization when a permissive change is granted.

10. We conclude that the proposed Class III change will benefit manufacturers by streamlining the equipment approval process. Manufacturers will no longer need to file a complete application form or much of the information required with a new certification application, which includes photographs, circuit diagrams and a description of the equipment. In addition, permissive changes to existing equipment are processed on a faster track than new certifications. We find that the proposed Class III permissive change strikes the appropriate balance between reducing the regulatory burden on manufacturers and protecting the public from interference and safety hazards from radio equipment. Accordingly, we are adopting the Class III permissive change for software defined radios.

11. We find that self-approval is not appropriate for software defined radios at this time. As we stated in the NPRM, equipment is generally placed in the self-approval category after the Commission has gained some assurance that manufacturers can and do produce equipment that complies with the rules. Given the early state of software defined radio technology, some experience with the equipment is necessary before we can determine whether self-approval is appropriate. We expect to re-evaluate the appropriateness of allowing manufacturers' self-approval for software defined radios in a future proceeding.

12. The NPRM proposed that Class III changes would only be permitted for a transmitter that was identified as a software defined radio in the original application for certification. The purpose of this proposal was to identify which devices would be subject to the new rules.

13. We will require the applicant to identify a software defined radio at the time an original application is filed in order for it to be eligible for Class III permissive changes. This will allow the application reviewer to determine which requirements the equipment must meet, such as the security features and labeling discussed below, and whether the applicant has demonstrated compliance with them. When applying for a Class III permissive change, the applicant must reference the initial declaration. We decline to establish a mechanism to reclassify previously approved devices as software defined radios. We find that such an approach would unnecessarily complicate the application process. Furthermore, additional supplementary information for existing equipment would have to be filed in any event. We note, however, that this approach would not prohibit the filing of a new request for an authorization as a software defined radio, permitting the device to be subsequently eligible for Class III permissive changes.

14. We proposed to allow only the party holding the grant of equipment authorization for a software defined radio to file for a Class III permissive change. The reason is that the party holding the grant of equipment authorization, which is indicated by the identification number, is responsible for ensuring that equipment complies with the rules. When a permissive change is made, the same identification number is used, indicating that the same party continues to be responsible for compliance with the rules. Allowing other parties to make permissive changes could result in questions of which party is liable if the changed equipment is subsequently found to be non-compliant.

15. We adopt our proposal to allow Class III changes to be requested only by the grantee of equipment authorization to eliminate ambiguities about which party is responsible for the compliance of a device. This approach would not preclude third parties from being able to modify software defined radios in the field. We agree with the comments that it is desirable to provide a means to allow third parties to develop new and innovative software for software defined radios. This can be accomplished in two ways. First, the original grantee may authorize a third party to file an application with the Commission on its behalf as we permit now. The original grantee would continue to be responsible for the continued compliance of the device. The second way is for a third party to obtain a new identification number for a device and become the party responsible for its compliance. The new identification number can be placed on the equipment through electronic labeling as discussed. The rules we are adopting allow any party to install or make changes to application or other software in a radio that does not affect the authorized operating parameters.

16.We proposed to allow Class III permissive changes only for equipment in which no hardware changes have been made from the originally approved device because this would eliminate ambiguity about which hardware and software combinations have been approved. However, the NPRM sought comments on whether we should allow a combination of hardware and software permissive changes in a single device.

17. We will permit combinations of Class III permissive changes and Class I permissive changes to hardware in a single device. Class I changes do not degrade the radio frequency emissions from a device, so allowing such combinations of hardware and software changes should not cause any compliance problems. However, at this time we will not permit Class III changes to be combined with Class II hardware changes that could affect radio frequency emissions. This could cause ambiguity in which combinations of hardware and software are approved in a radio, making enforcement of the rules difficult. Also, as some comments noted, combinations of changes made at different times could have unknown effects on the interference potential and RF safety of a radio. In addition, we question whether a radio in which any hardware changes are necessary to change operating parameters should even be considered a software defined radio. However, we will consider revisiting this issue as the Commission and industry gain greater experience with software defined radios.

18. The NPRM sought comment on whether we should limit the number of hardware and software combinations permitted under a single authorization. We noted that some transmitters are tested with multiple antennas to ensure they will comply in every configuration in which they will be used, and that allowing software variations could increase the number of hardware and software combinations existing under a single approval.

19. We agree with the commenting parties who argue that no limit should be placed on the number of hardware and software combinations. Such limits could inhibit common hardware platforms. We have no reason to expect that such a large number of combinations will exist for a particular device that a determination of compliance would be difficult. We will not permit hardware changes that degrade the operating parameters to be made after the initial approval, which will help limit the number of hardware/software combinations under a single approval. We will continue to monitor this area and revisit this issue in the future if warranted.

20. The NPRM sought comments on whether there is a need for applicants to submit a copy of radio software to the Commission. Review of software code by the staff would be difficult and time consuming and would not necessarily assist in determining whether a device complies with the rules. We believe that obtaining a copy of the code from an applicant would not be necessary for determining compliance in the great majority of cases. Accordingly, we will not routinely require applicants to supply a copy of the radio software. However, we believe cases may arise wherein the staff may need to examine the software code used in a device as part of determining its compliance. We therefore may require the submission of software code on request.

21. The NPRM proposed to apply the filing fee for certification of transmitters used in licensed services to the new Class III permissive changes to reflect the staff time required to process these changes. While the filing procedure for permissive changes has been streamlined, Commission staff is still required to perform a technical review of the test data for compliance with the rules. We are therefore adopting the fee we proposed for Class III permissive changes. This fee reflects the expected review time for Class III changes and is the same as we require for approval of transmitters used in licensed services. Where a radio will operate under multiple rule parts, requiring increased review time, we will charge multiple fees as currently set out in the rules.

22. We tentatively concluded in the NPRM that a means will be necessary to avoid unauthorized modifications to software that could affect the compliance of a radio. Because groups such as the SDR Forum and ETSI are still in the process of developing standards for encryption and digital signatures that could be used in software defined radios, we declined to propose specific requirements for authentication. Instead, we proposed a more general requirement that manufacturers take steps to ensure that only software that is part of a hardware/software combination approved by the Commission or a TCB can be loaded into a radio. The radio software must not allow users to operate the radio with frequencies, output power, modulation types or other parameters outside of those that were approved. We proposed to allow manufacturers to use any appropriate means to meet these requirements and require them to describe the methods in the application for equipment authorization.

23. We find that a means is necessary to ensure that software changes cannot be made to a radio that will cause it to operate with parameters outside of those that were approved in order to prevent interference to authorized radio services. We decline to set specific security or authentication requirements at this time because they could hinder the development of the technology used to provide such security and could have the potential to be unduly burdensome on manufacturers. We note that industry groups are still in the process of developing security standards. We continue to believe that the best approach is to rely on a general requirement that manufacturers take adequate steps to prevent unauthorized changes to the software that drives their equipment. This will allow manufacturers flexibility to develop innovative software defined transmitting equipment while at the same time providing for oversight of the adequacy of such steps through the equipment authorization process. Accordingly, we are adopting the proposal in the NPRM that manufacturers must take steps to prevent unauthorized software changes to a software defined radio. The precise methods of ensuring the integrity of the software in a radio will be left to the manufacturer, and the manufacturer must document the methods in the application for equipment authorization. However, it is possible that we may have to specify more detailed security requirements at a later date as software defined radio technology develops. Our intent is to focus on results that security efforts should achieve rather than the means that must be used. The SDR Forum has indicated that it is continuing to develop methods for the security and authentication of radio software and that it will report its findings to the Commission. We will consider further input from industry and other government agencies in determining whether more detailed security requirements are necessary. We encourage all interested parties to submit relevant information within one year of adoption of this order.

24. A major benefit of software defined radios will be the ability of manufacturers to produce radios intended to be programmed by third parties with unique or specialized software. To help realize this benefit, we proposed an option that would allow software defined radios to be equipped with an “electronic label” to display the FCC identification number by means of a light emitting diode (LED) display, a liquid crystal display (LCD) or other similar method. This would provide a method to re-label equipment in the field if a new approval were obtained by a third party for a previously approved device.

25. We will permit electronic labeling for software defined radios as proposed. This option will avoid the need for physical re-labeling of equipment when a party other than the original grantee makes changes to the radio software. We do not agree with Clearwire's proposal to require only a single identification number on each device. As we stated, the FCC identification number is the indicator of which party is responsible for the compliance of a device and we have determined that only the original grantee may make changes to the operating parameters under the original identification number. At this time, we are only permitting electronic labeling for software defined radios.

26. Several parties believe that we should allow means other than an LED or LCD screen for displaying the labeling information. We are limiting electronic labeling to software defined radios with an LED, LCD or similar display device at this time because it would be significantly more difficult to an investigator or user to obtain the label information through a remote terminal or other device. As proposed, we are requiring that the electronic label be readily accessible, which could include, for example, a menu option or a hotkey. Additionally, the user manual must include information on how to access the electronic label. We are not requiring that the electronic labeling be visible when the power, such as the battery pack, is removed from the device. This would burden manufacturers by requiring them to install a backup battery and possibly additional switches and circuitry to display the identification information.

27. Cingular believes that electronic labels should display the FCC identification number, and that the display should change automatically based upon the hardware and software installed. The SDR Forum believes that nothing about the required identification information should change, other than the means of display. NTIA believes that all the information currently required on the label could be made available on the user display screen. NTIA also wants the Commission to make clear what other information must be included on the electronic label, such as the authorized emissions or other regulated radio parameters.

28. We agree with Cingular and will only require that the FCC identification number(s) associated with the software running in the radio be displayed on the electronic label. The other information that NTIA suggested including on the label is already in the Commission's database under the FCC identification number. The database is available to the public through our Internet site, so we do not believe it is not necessary to require information on the operating parameters on the electronic label. Manufacturers may design their equipment to display any additional information they wish beyond what we require.

29. We tentatively concluded in the NPRM that software defined radio technology has not matured to the point where it is possible to predict the radio frequency characteristics of a radio from either the hardware or software alone. Therefore, we proposed that each combination of hardware and software that a radio supports should be tested because it is the only way to ensure that equipment complies with the technical standards in our rules to prevent interference and to protect users from excessive RF radiation. We anticipated that testing each hardware/software combination that will be used in a software defined radio would be no more burdensome than testing each mode in which a radio operates, which is the existing process.

30. As proposed, we will require that software defined radios be tested for compliance with each software application under which the radio will operate. Except as provided below, where the hardware portion of the software defined radio can support multiple software applications, we will not require that the device be tested with combinations of software. We find no reason to believe that the presence of additional compliant software applications in the radio would affect the radio's performance or raise additional compliance issues. Where the radio is capable of operating with multiple software applications simultaneously, that is, the software defined radio can transmit simultaneously multiple signals or in multiple frequency bands, we will require that the radio be tested to ensure that the device complies with all applicable rules. For this case, we believe that additional testing is needed. For example, software defined radios that enable multiple simultaneous carriers could raise compliance issues with RF safety limits because the total output power would be increased or could produce intermodulation products that would result in emissions higher than those permitted under the rules. We anticipate that a relatively small number of software defined radios will have this capability to transmit multiple signals. We believe that this approach reasonably balances our need to ensure that devices comply with our rules and do not cause interference with the concerns expressed by some parties regarding burdensome testing requirements.

31. In General Docket 98-68, 64 FR 04984, February 2, 1999, we established the requirements for TCBs that are allowed to approve equipment in the same manner as the Commission. In that proceeding, we stated that while we intended to use TCBs to certify a broad range of equipment, we found that certain functions should continue to be performed by the Commission. The functions included certifying new or unique equipment for which the rules or requirements do not exist or for which the application of the rules is not clear. Because software defined radios are a new technology and many questions about the application of the rules may arise, we tentatively concluded in the NPRM that TCBs should not be permitted to certify software defined radios or approve permissive changes to software defined radios for at least six months after the effective date of final rules adopted in this proceeding.

32. We believe that six months is a reasonable minimum time period to allow the Commission to gain experience with software defined radios and determine whether TCBs should be permitted to certify them. As the SDR Forum noted, we proposed six months only as a marker for reassessment and may extend the time period if necessary. Accordingly, TCBs will not be permitted to certify software defined radios until at least six months after the effective date of the rules adopted in this proceeding. The Chief of the Office of Engineering and Technology acting under the existing delegated authority will determine when TCBs may certify software defined radios and will announce this decision by public notice.

33. We recognized in the NPRM that a non-compliant software defined radio has the potential to interfere with other radio services due to its potential to operate in multiple frequency bands. We requested comments on whether we should enhance our enforcement capabilities due to the development of software defined radios and what particular changes we should make.

34. We are not planning to increase our enforcement capabilities specifically for software defined radios because we have no reason at this time to expect significant compliance problems. However, we note that more of the routine application processing that has previously been handled by the Commission is now being performed by TCBs. This shifting of the workload will free up resources at our Laboratory that can be used to increase post-market surveillance on all types of equipment, including software defined radios. We cannot increase the maximum fines that may be issued for non-compliant equipment because they are limited by statute. We will carefully assess the deployment of software defined radios in the market to determine whether any increased enforcement efforts are warranted and, if appropriate, whether other actions such as a faster revocation procedure for the authorizations of non-compliant software defined radios may be necessary.

35. As required by the Regulatory Flexibility Act (RFA),1 an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rule Making, Authorization and Use of Software Defined Radios.2 The Commission sought written public comment on the proposals in the Notice, including comment on the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.3

36. We are adopting changes to our equipment authorization rules in this Order to facilitate the deployment of software defined radios. The rule changes will streamline the equipment approval process and reduce the burden on applicants by eliminating the need to file a complete new application and physically re-label equipment when changes are made to the frequency, modulation type or output power of a software defined radio. In a software defined radio, functions that were carried out by hardware in the past are performed by software. This means that the operating parameters of the radio, such as the frequency and type of modulation, could be readily changed in the field. The rules previously required a complete new application and a new identification number on a permanently affixed label when changes to these operating parameters were made. The previous requirements could have discouraged the deployment of software defined radios to consumers.

37. No comments were submitted directly in response to the IRFA. In addition, we have carefully examined all comments filed in response to the Notice and have determined that none specifically address the effect of the proposed rules on small entities.

38. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, herein adopted.4 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 5 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.6 A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.7

39. The Commission has not developed a definition of small entities specifically applicable to Radio Frequency Equipment Manufacturers (RF Manufacturers). Therefore, the applicable definition of small entity is the definition under the SBA rules applicable to manufacturers of “Radio and Television Broadcasting and Communications Equipment.” According to the SBA's regulation, an RF manufacturer must have 750 or fewer employees in order to qualify as a small business.8 Census Bureau data indicates that there are 858 companies in the United States that manufacture radio and television broadcasting and communications equipment, and that 778 of these firms have fewer than 750 employees and would be classified as small entities.9 We believe that many of the companies that manufacture RF equipment may qualify as small entities.

40. We are establishing a new class of “permissive change” for software defined radios when changes are made to the software that affect the frequency, power or type of modulation. This class of change will require the manufacturer to submit a description of the software changes to the FCC or a designated Telecommunications Certification Body (TCB). The manufacturer will also be required to submit test data showing that the radio complies with the technical standards in our rules with the new software loaded. The new software cannot be loaded into radios until the FCC or TCB notifies the manufacturer that the changes are acceptable. The original FCC identification number for the equipment can continue to be used, so no re-labeling is required.10

41. We are also allowing an “electronic label” to be used on software defined radio transmitters as an alternative to the permanently affixed label the rules require for other types of devices. The equipment can display the FCC identification number by means of a liquid crystal display or similar screen.11

42. We are requiring manufacturers to take steps to ensure that only software that has been approved by the FCC or a TCB can be loaded into a transmitter. The software must not allow the user to operate the transmitter with frequencies, output power, modulation types or other parameters outside of those that were approved. Manufacturers may use authentication codes or any other means to meet these requirements, and must describe the methods in their application for equipment authorization.12

43. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.13

44. The rules adopted in this proceeding apply equally to all entities, including small entities. The rules streamline the approval process for changes to the operating parameters of software defined radios and give additional flexibility to manufacturers by permitting equipment to be labeled electronically instead of with a physical label. The benefits of these streamlined rules are granted to all entities in the same way, including small entities. There is no adverse impact on any entities large or small.14

45. A significant alternative we considered but rejected, which if adopted might have slightly reduced the burden on small entities, is to allow software changes to be approved under the Declaration of Conformity (DoC) procedure. DoC is a self-approval procedure in which the manufacturer has the equipment tested for compliance at an accredited laboratory. Once the equipment has been found to comply, it may be marketed without any approval from the FCC or a TCB. Although this alternative might have reduced the burden on small entities, we declined to adopt it because we believe that software defined radio transmitters require a higher level of oversight to ensure that they comply with the rules to prevent interference and protect users from excessive RF radiation. Certain radio transmitters are already permitted to be self-approved, and we are not making any change in the authorization requirements for them.

46. Even though the rules adopted in this First Report and Order affect all entities, including small entities, equally and confer the same benefits upon all entities, including small entities, we note that software defined radio is an evolving technology. If issues particularly involving smaller entities arise, these will be examined when we revisit this area in future proceedings. On careful reflection, we note that no commenter stated that any rule adopted herein impacts small entities in a manner different from larger entities.

47. Report to Congress: The Commission will send a copy of the First Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A). In addition, the Commission will send a copy of the First Report and Order, including FRFA, to the Chief Counsel for Advocacy of the Small Business Administration.

48. Parts 1 and 2 of the Commission's Rules and Regulations are amended, February 4, 2002. Authority for issuance of this First Report and Order is contained in Sections 4(i), 301, 302, 303(e), 303(f), 303(r), 304, 307 and 332(b) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 302, 303(e), 303(f), 303(r), 304, 307 and 332(b).

This is a summary of the Commission's, Order, CC Docket No. 97-213, FCC 01-265, adopted September 18, 2001, and released September 21, 2001. The full text of this Commission decision is available on the Commission's Internet site at www.fcc.gov. It is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW., Washington, DC, and also may be purchased from the Commission's duplication contractor, Qualex International , (202) 863-2893, Room CY-B402, 445 12th Street, SW., Washington, DC 20554. Comments may sent as an electronic file via the Internet to http://www.fcc.gov/e-file/ecfs.html, or by e-mail to ecfs@fcc.gov.

1. In the Third R&O, released in August 1999, 65 FR 51710, September 24, 1999, the Commission specified technical requirements for wireline, cellular, and broadband PCS carriers to comply with the assistance capability requirements prescribed by the Communications Assistance for Law Enforcement Act of 1994 (“CALEA”). We took this action under Section 107(b) of CALEA in response to petitions filed with us that claimed that industry standards for electronic surveillance failed to satisfy the four general assistance capability requirements in Section 103 of CALEA. Under Section 107(a)(2) of CALEA (the “safe harbor” provision), carriers and manufacturers that comply with industry standards for electronic surveillance are deemed in compliance with their specific responsibilities under Sections 103 and 106 of CALEA. The Commission is authorized, under Section 107(b) of CALEA, in response to a petition from any Government agency or person, to establish, by rule, technical requirements or standards if industry associations or standard-setting organizations fail to issue technical requirements or standards or if any Government agency or person believes that such requirements or standards are deficient.

2. In the Third R&O, we required that wireline, cellular, and broadband PCS carriers implement all electronic surveillance capabilities of the industry interim standard, J-STD-025—including two contested features of the interim standard, i.e., a packet-mode communications capability and a location information requirement—and six of nine additional capabilities requested by DoJ/FBI, known as the “punch list” capabilities. While we required a packet-mode capability, we did not adopt specific technical requirements for packet-mode communications. Rather, we permitted carriers to deliver packet-mode data to be delivered to law enforcement agencies (“LEAs”) under the interim standard pending further study of packet-mode communications by the telecommunications industry. We required that the capabilities covered by the “core” interim standard—including all uncontested requirements of J-STD-025, as well as the contested location information requirement—be implemented by June 30, 2000, and that the packet-mode and punch list capabilities be implemented by September 30, 2001.

3. Several parties challenged in the United States Court of Appeals for the District of Columbia Circuit six capabilities required by the Third R&O: location information and packet-mode communications, both of which were included in J-STD-025; and dialed digit extraction, party hold/join/drop, subject-initiated dialing and signaling, and in-band and out-of-band signaling, which are four of the six punch list capabilities requested by DoJ/FBI that we added to J-STD-025. In August 2000, the Court vacated and remanded to us for further proceedings those portions of the Third R&O pertaining to the four challenged punch list capabilities. The Court upheld our findings in the Third R&O regarding location information and packet-mode communications, but with respect to the latter stated: “CALEA authorizes neither the Commission nor the telecommunications industry to modify either the evidentiary standards or procedural safeguards for securing legal authorization to obtain packets from which call content has not been stripped, nor may the Commission require carriers to provide the government with information that is “not authorized to be intercepted.”'

4. Following the Court Remand Decision, CTIA filed a petition to immediately suspend the September 30, 2001 compliance deadline for implementing the two unchallenged punch list capabilities—content of subject-initiated conference calls and timing information—and the packet-mode communications capability. In its petition, CTIA states that the compliance deadline for those capabilities should be suspended to ensure an orderly and cost-efficient implementation of the punch list and packet-mode communications capabilities. With respect to the punch list, CTIA argues that disentangling the four vacated capabilities from the two remaining capabilities would be a complex and inefficient process. CTIA therefore recommends that we suspend the compliance date for the entire punch list pending resolution of what capabilities are required. With respect to packet-mode communications, CTIA argues that the Court found that telecommunications carriers could not lawfully deliver the full content of a packet to a LEA under a “pen register” order. CTIA further argues that we may receive petitions that request that we declare the current packet-mode standard deficient because it fails to protect the privacy of communications not authorized to be intercepted. Accordingly, CTIA argues that it would be prudent for us to suspend the packet-mode compliance deadline until we have all of the information necessary to make a realistic compliance determination.

5. On September 1, 2000, our Office of Engineering and Technology (“OET”) placed the CTIA Petition on Public Notice and on September 15, 2000, OET received comments responding to the CTIA Petition. The great majority of commenting parties support grant of the Petition; however, DoJ/FBI oppose any extension of the packet-mode compliance deadline.

6. In April 2000, we issued a Public Notice providing instructions for those carriers needing to file petitions for extension of the June 30, 2000 deadline for complying with the capability requirements of CALEA section 103. In that Public Notice, we noted that section 107(c)(3) authorizes us to extend the compliance deadline for no longer than two years from the date of the petition's grant. We also noted that the FBI has provided each carrier an opportunity to participate in a “Flexible Deployment Program,” under which the FBI has agreed to review a carrier's extension request in light of the priorities of LEAs. We further noted that, for carriers serving geographic areas that do not have a history of demand by LEAs for electronic surveillance, the FBI may advise us that extensions of the section 103 compliance deadline do not unduly threaten the public safety. Accordingly, we urged each carrier seeking an extension of the June 30, 2000 CALEA deadline to participate in the Flexible Deployment Program before submitting to us a section 107(c) petition for extension of time to comply. A number of carriers chose to participate in the Flexible Deployment Program, and we have made preliminary determinations to suspend the June 30, 2000 deadline for many of those carriers. On August 15, 2001, our Common Carrier Bureau released an Order making final determinations to grant extensions of the June 30, 2000, deadline to several hundred wireline carriers. We anticipate making final determinations on other wireline—as well as wireless—carriers’ requests for extensions of that deadline in the near future. We also note that in August 2001 the FBI released a Second Edition of its Flexible Deployment Program. This Second Edition pertains to packet-mode communications and is designed to assist carriers in meeting packet-mode requirements mandated by CALEA.

7. There is broad agreement among industry and law enforcement that we should suspend the September 30, 2001 compliance deadline for the two unchallenged punch list capabilities, pending a final action by the Commission of what punch list capabilities will be required. We agree with the majority of commenters that retaining the current deadline for two of the punch list capabilities prior to determining the disposition of the four punch list capabilities vacated by the Court Remand Decision could result in major inefficiencies for carriers. Moreover, there is insufficient corresponding benefit in implementing these two capabilities by themselves to warrant disruption and costs such a severable implementation would entail. Most carriers use more than one type of switch in their networks, often from different manufacturers. Most manufacturers have developed a CALEA solution that includes all six punch list capabilities that the Third R&O required; some manufacturers have included the core interim standard and the punch list capabilities in one software package, others have separated the core interim standard and punch list capabilities into different software packages. Some software packages allow each punch list capability to be toggled, while other software packages do not allow toggling. In either case, carriers have to install and test the full software package. Carriers will have to test software with toggling functions to ensure that toggling off some capabilities does not interfere with the provision of other capabilities. For those software packages that do not allow toggling, carriers would have to implement the whole software package by the current September 30, 2001 deadline, absent an extension from the Commission, if the software could not be modified before then either to remove the four vacated punch list capabilities or to provide a toggle on/off function. While we believe that LEAs will cooperate with carriers to minimize the burden on carriers, we find, under these circumstances, such an approach to be inherently burdensome and inefficient. Furthermore, a temporary suspension of the compliance date for the unchallenged capabilities will ensure that all punch list capabilities that may ultimately be required will proceed on the same compliance schedule. In any event, we anticipate that we would likely receive and grant many individual petitions for extension, which would be an unwarranted exercise and expenditure of resources. While we encourage carriers to make available to LEAs any surveillance capability they have available, we recognize that the deployment of software with the punch list capabilities will vary from carrier to carrier.

8. Accordingly, pursuant to our authority to provide a reasonable time and conditions for compliance with and the transition to any new standard, we are temporarily suspending the current September 30, 2001, deadline for all punch list capabilities, including the two unchallenged punch list capabilities (i.e., subject-initiated conference calls and timing information), pending the Commission's final action on the Court Remand Decision. We anticipate that we will establish a new compliance date for all required punch list capabilities in time to allow carriers to be fully CALEA-compliant no later than June 30, 2002. We arrive at this outside target date because we intend to address the Court Remand Decision no later than year's end. We intend to act as expeditiously as possible on the remand, before year's end if possible, believing it to be a priority of this agency. The record indicates that carriers can implement any required changes to their software within six months of our decision.

9. With regard to a packet-mode communications electronic surveillance capability, we find no need to extend the September 30, 2001, compliance deadline in the blanket manner requested by CTIA. While we deny CTIA's section 107(c) petition for a blanket extension for the reasons stated above, we believe that the record supports a brief extension in order to allow carriers additional time for compliance with and transition to the packet-mode standards. Given the imminence of the September 30, 2001 deadline, we believe that a brief extension is necessary to allow carriers additional time to upgrade their systems to incorporate the packet-mode capability or to allow any carriers wishing to avail themselves of the section 107(c) petition procedure a reasonable amount of time to prepare their petitions, including the technical justification required therein. Briefly extending the deadline will also provide any carriers that wish to voluntarily participate in the FBI's Flexible Deployment Program with respect to packet-mode communications the time necessary to prepare the documentation, including technical data relating to the carrier's system, as required under the program and allow Commission staff to announce the section 107(c) filing procedures with respect to packet-mode communications. Accordingly, pursuant to our authority under section 107(b)(5) of CALEA and sections 4(i) and (j) of the Communications Act, we grant, sua sponte, an extension until November 19, 2001, for wireline, cellular, and broadband PCS carriers to implement a packet-mode capability. We view this brief extension as extraordinary relief necessary in the interests of fairness and reasonableness and do not expect to grant any further extensions on an industry-wide basis with respect to packet-mode communications. We therefore encourage any carriers unable to meet the November 19, 2001 deadline to seek individual relief under the section 107(c) procedures. In this regard, we direct the Common Carrier Bureau and the Wireless Telecommunications Bureau to release a Public Notice further explaining the section 107(c) petitioning process with respect to packet-mode communications.

10. Pursuant to sections 1, 4, 229, 301, 303, and 332 of the Communications Act of 1934, as amended, and section 107(b) of the Communications Assistance for Law Enforcement Act, 47 U.S.C. 151, 154, 229, 301, 303, 332, and 1006(b), the Petition to Suspend Compliance Date, filed August 23, 2000 by CTIA, is Granted in part and denied in part.

This is a synopsis of the Commission's Memorandum Opinion and Order in MM Docket No. 95-88, adopted August 13, 2001, and released August 17, 2001. The full text of this decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Qualex International, Portals ll, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.

The 1994 amendments to the MMPA (section 104(c)(5)(A)) allow for the issuance of permits to import sport-hunted polar bear trophies from Canada when we can make certain legal and biological findings. On February 18, 1997, we published regulations in the Federal Register (62 FR 7302) that established standards for the issuance of permits to allow the import of sport-hunted polar bear trophies (50 CFR 18.30). The regulations contain aggregate findings applicable for multiple harvest seasons for five populations, including M'Clintock Channel, as follows: (a) Canada has a sport-hunting program that allows us to determine before import that each polar bear was legally taken; (b) Canada has a monitored and enforced program that is consistent with the purposes of the 1973 International Agreement on the Conservation of Polar Bears; (c) Canada has a sport-hunting program that is based on scientifically sound quotas ensuring the maintenance of the affected population stock at a sustainable level for certain populations; and (d) the export of sport-hunted trophies from Canada and their subsequent import into the United States would be consistent with the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and would not likely contribute to illegal trade of bear parts. In a subsequent final rule on January 11, 1999 (64 FR 1529), we made aggregate findings that approved two additional populations.

In Canada, management of polar bears has been delegated to the provinces and territories. However, the Canadian Wildlife Service (CWS), Canada's national wildlife agency, maintains an active research program and is involved in the management of populations that are shared between jurisdictions, particularly between Canada and other nations. In addition, Native Land Claims have resulted in co-management boards for most of Canada's polar bear populations. The Nunavut Wildlife Management Board (NWMB) is the main instrument of wildlife management in the Nunavut Settlement Area, while the Government of Nunavut (GNUN), through the Minister of Sustainable Development, retains the ultimate responsibility for both the conservation of wildlife and economic development in the Nunavut Territory. The co-management of Nunavut's polar bear populations also includes the CWS, regional wildlife organizations, and hunters and trappers organizations. The Federal/Provincial/Territorial Polar Bear Technical Committee (PBTC) and Polar Bear Administrative Committee meet annually to ensure a coordinated management process among these parties.

The basis of the Government of Northwest Territories (GNWT) and GNUN polar bear management program is that the human-caused killing of polar bears (e.g., harvest, defense, or incidental) must remain within the sustainable yield, with the anticipation of slow growth for any population. The program has several components including: (a) Use of scientific studies to determine and monitor changes in population size and establish population boundaries; (b) involvement of the resource users and incorporation of traditional knowledge to enrich and complement scientific studies; (c) harvest data collection and a license tracking system; and (d) enforcement measures through regulations and management agreements.

Regulations and management agreements between the GNWT, GNUN, and Native Land Claim beneficiaries provide the rules for polar bear harvest in the Northwest Territories (NWT) and Nunavut. The hunting season opens August 1 and closes May 31 the following year. Except for defense kills, no harvest usually occurs before February. The hunting season is limited by factors such as the lack of sea ice, the number of daylight hours, and winter weather conditions. Sport hunts are typically conducted in the spring, between March and May. Sport hunting of polar bears is presently legal only in NWT and Nunavut and includes additional requirements. All sport hunts must be conducted under Canadian jurisdiction and be guided by a Native hunter. In addition, transportation during the hunt must be by dog sled, the tags must come from the community quota, and quota tags from unsuccessful sport hunts may not be used again. All bears taken by sport hunters must be accounted for within existing quota tags. Not all communities participate in sport hunting as it reduces hunting opportunities for local hunters. You should refer to the February 18, 1997 (62 FR 7302), and January 11, 1999 (64 FR 1529), rules for more extensive information on Canada's polar bear management program.

In an emergency interim rule effective and published in the Federal Register on January 10, 2001 (66 FR 1901), we amended our regulations under the MMPA in 50 CFR 18.30 on the import of polar bears taken by sport hunters in the M'Clintock Channel population, Nunavut, Canada. Under the Administrative Procedure Act (5 U.S.C. 551-553), our normal practice is to publish regulations with a 30-day delay in effective date. But in this case, we used the “good cause” exemptions under 5 U.S.C. 553(b) and (d)(3) to issue the emergency interim rule without first invoking the usual notice and public comment procedure and to make the rule effective upon publication for the following reasons: (1) Official information submitted by the government of Canada showed that the M'Clintock Channel population no longer meets the import requirements of the MMPA; (2) as a matter of fairness to the regulated community, it was necessary to put the public on notice immediately that bears sport hunted in the M'Clintock Channel population after May 31, 2000, would no longer be eligible for import under the finding which approved this population for multiple harvest seasons; and (3) it would be contrary to the public interest to maintain regulatory findings that purport to allow the import of these polar bear trophies when those findings are no longer consistent with the MMPA.

We are adopting the emergency interim rule as a final rule without substantive change. In the emergency interim rule, we found that the M'Clintock Channel population no longer meets the import requirements of the MMPA and amended our regulations to reflect that bears sport hunted in this population after May 31, 2000, the end of the 1999/2000 Canadian hunting season, will no longer be eligible for import under the 1997 finding which approved this population for multiple harvest seasons. In addition, the emergency interim rule updated our regulations to reflect the formation of the new territory of Nunavut and notified the public on the lifting by Canada of the harvest moratorium in the Viscount Melville Sound polar bear population.

The use of an emergency interim rule allowed us to take action based on the new information for the M'Clintock Channel population, quickly inform the public about the change to the regulations, and, at the same time, ask for comments from the public. We received comments on the emergency interim rule from the CWS, Conservation Force, Safari Club International (SCI), and the Humane Society of the U.S. (HSUS). We received submissions from the Department of Sustainable Development, GNUN, and the NWMB after the close of the comment period, and this information is presented in the preamble of this final rule because it clarifies historical information, population analysis, and current management of the M'Clintock Channel polar bear population. However, we note that, although the information was important in giving an accurate description of polar bear status and management in Nunavut, it did not affect the outcome of the final rule. Finally, comments were also provided by the Marine Mammal Commission (MMC) and its Committee of Scientific Advisors, as part of the consultative process required by the MMPA. Our summary and response to public comments are given in the sections in the preamble that discuss the issues.

As described in our February 18, 1997 (62 FR 7302), final rule, Canada estimated the M'Clintock Channel population in the mid-1970s to be 900 polar bears based on a 6-year mark-recapture population study. According to the GNUN, this study was part of the first Territorial Government polar bear population inventory conducted in the Central Arctic. The existing mark-recapture population analysis models at that time were based on simplifying assumptions and did not have the benefit of current genetic and satellite telemetry technology. Originally, the M'Clintock Channel and Gulf of Boothia areas were not identified as distinct units and the combined estimate for these two “subpopulations” was 1,081 bears. Due to the known bias of non-representative sampling, the estimate was later increased to 900 for the M'Clintock Channel and 900 for the Gulf of Boothia, based on the assumption that harvests at that time were sustainable. Subsequently, local hunters advised that 700 might be a more accurate estimate for the M'Clintock Channel population. Under a Local Management Agreement between Inuit communities that share this population, the harvest quota for this area was revised to levels expected to achieve slow growth based on the population estimate of 700 polar bears. We approved this population although Canada considered the population estimate information as “poor.” We made this decision because Canada, in conjunction with the local communities, agreed to the reduction (from 900 to 700) in the population estimate, hunting had been at a 2 male to 1 female sex ratio for several years, and there was a management agreement in place.

Canada initiated a new study of the polar bear population in M'Clintock Channel in 1998 to assess the population size currently being used to calculate harvest quotas. At the 2000 PBTC meeting, the GNUN presented preliminary results of the mark-recapture analysis based on data collected during 1998 and 1999. Although cautioning that the results were incomplete, the polar bear managers estimated that the newly revised population size for the M'Clintock Channel population was between 360 and 390 bears, considerably lower than the previous estimate of 700. The GNUN considered the reliability of the new estimate “poor,” and noted that a more accurate estimate was to be calculated following the end of the 3-year mark-recapture study.

Following the end of the study in 2000, the GNUN provided us with preliminary results based on data collected in 1998, 1999, and 2000. The recalculated population estimate of polar bears in M'Clintock Channel was between 238 and 399 bears, with 288 as the best preliminary estimate. Based on this updated estimate, the GNUN recalculated the maximum sustainable harvest that would support the population at its current level, with no population growth, at 8 bears per year (4 males and 4 females). The quota since 1993 has been set at between 32 and 34 bears. The GNUN indicated that, at that rate of harvest, the population was declining and would be reduced to zero in 10 years. With no harvest, the population would increase at only 4 percent annually. Thus, recovery of this population will be slow and each year of over-harvest will delay recovery time by a minimum of 2 years. The GNUN noted that it would be evaluating future management goals for this population such as identifying a target population recovery level. At the 2001 PBTC meeting, the GNUN estimated that the time for an unharvested polar bear population to double is about 25 years, and indicated that a long-term moratorium may be necessary for the M'Clintock Channel population to recover its former numbers.

In 2001, the GNUN conducted more stringent analyses of the 1998 to 2000 mark-recapture data. Using two different stratified mark-recapture models, estimates of 455 (standard error = 215) and 243 (standard error = 49) bears were calculated for the M'Clintock Channel population. The GNUN was unable to produce satisfactory estimates using these models, which they attribute to capture heterogeneity. Based on an average of the best analysis models following Burnham and Anderson (1998), the GNUN calculated what they consider the current best estimate, 367 bears (standard error = 191), for the M'Clintock Channel population. We note that the GNUN's re-analysis of the base core population numbers resulted in an increase from the preliminary estimate of 288 bears, as reported in the emergency interim rule, to the current best estimate of 367 bears. This increase is not sufficient to remove our concern that the M'Clintock Channel population has been severely reduced, nor affect the outcome of this final rule. We consider the mid-1970's estimate of 900 bears to be the best information available for the historical baseline of this population. Even though each subsequent revision of the population estimate was considered “poor” by Canada, we have accepted the updated estimates as the best information available at the time. We conclude that the current best estimate of 367 bears indicates that the M'Clintock Channel population has severely declined over time, and is consistent with our findings in the emergency interim rule.

Further, the CWS reports that extensive new data analysis and field work need to be conducted before revisions to the population estimate for the M'Clintock Channel can be made. The GNUN suggests that at least 2 to 3 additional years of sampling will be required before accurate estimates of survival and population numbers can be obtained. The GNUN plans to continue the mark-recapture study and collect additional population data as early as 2002. The CWS has indicated that it will continue to provide new population information to us as it becomes available.

The quota for the M'Clintock channel population, based on a population estimate of 700 bears, has been set at between 32 and 34 bears since 1993. At the time the emergency interim rule was published, Canada had made no adjustment to the quota to reflect the new population information since polar bears are co-managed with local communities through agreements and any modification requires community consultation. Discussions with local communities to develop the best plan of action were completed earlier this year.

On January 16, 2001, the Minister of Sustainable Development, GNUN, accepted the decision of the NWMB to reduce the quota for the M'Clintock Channel population to 12 polar bears (8 males and 4 females) for the 2000/2001 harvest year followed by a moratorium on harvest in 2001/2002. The NWMB based their decision on the community recommended quota of 12 animals and the available information that suggested if the full quota of 12 were taken for the 2000/2001 harvest season, the average harvest over the 2 years would be 6, which was within the harvest limits considered by Canada to be sustainable for the lowest population estimate. The GNUN explained that the quota reduction in 2000/2001 and harvest moratorium in 2001/2002 will provide time for further community consultation while protecting the population from additional decline.

The NWMB further explained that, as part of the co-management process, any change in the quota must not rely solely on scientific data but must also take into account traditional knowledge. The NWMB will work with their co-management partners to ensure traditional knowledge information is collected and integrated with the scientific information in order to better manage the M'Clintock Channel polar bear population. The NWMB also noted that both cultural and economic aspects must be taken into account in the recovery plan, as a small quota, even in a severely reduced population, may be used as an effective conservation measure. The GNUN agreed that enhanced economic value is a positive factor in co-management conservation strategy. Over the next year, the GNUN and NWMB will work with their co-management partners to assess the situation for the M'Clintock Channel population and develop a long-term strategy and recovery goals.

The SCI and Conservation Force recommended that our decision take into account the benefits of sport hunting which provide conservation incentives, management revenues, and income for the local communities. We recognize that, under certain conditions, sport hunting can be a useful management tool and Canada has incorporated it into their management program for polar bears. However, the MMPA requires us to consider not whether sport hunting is beneficial but whether Canada's management is based on scientifically sound quotas that ensure the maintenance of the population at a sustainable level. Long-term management programs based on sustainability will yield greater economic benefits than short-term programs that are not based on sound principles of resource optimization.

Although the SCI agreed that the current data indicate either a reduced population or a previous overestimate, they felt that our emergency interim rule was premature and arbitrary because it resulted in a complete loss of sport-hunting revenue for the local communities and interfered with the co-management process. SCI and NWMB suggested that we modify the emergency interim rule to allow the import of sport-hunted polar bears taken under the reduced quota because a complete ban on import would be an economic and cultural detraction to local people. We disagree with the SCI that our decision was arbitrary. Our decision was based on the best available information which indicates the M'Clintock Channel population has been severely reduced and that this population no longer meets the statutory criteria of the MMPA under which imports may be authorized. While we recognize Canada's co-management system, and its need to balance cultural, economic, and conservation concerns, we must make our decision on specific criteria in the MMPA set out by Congress. Indeed, we consider this population to have severely declined from its historical population of 900 bears, and so cannot make the finding that the population is being maintained at a sustainable level, even under the reduced quota. Under the purposes and conservation goals of the MMPA, once the population has declined so severely, any take of bears would not be considered sustainable. The reduced quota set by Canada may indeed keep this population from declining any further, but does not work toward recovering the population to its historical population. The GNUN has estimated that, with no harvest, the population would increase at only 4 percent annually and take about 25 years to double. Thus, it is clear that the recovery of the population will be slow and, even with a long-term moratorium, it will be many years before the M'Clintock Channel population will be able to recover its former numbers. The MMC agreed with us that it does not appear that the management of the M'Clintock population has been based on scientifically sound quotas ensuring the maintenance of the population at a sustainable level as required by the MMPA. We note that the GNUN wrote that its goal is the sustainable use of polar bear populations, and the MMPA import criteria do not conflict with its current or developing polar bear management policies. The GNUN plans to identify a target recovery level as it evaluates future management goals for this population.

The HSUS and MMC supported our decision to change the import status of the M'Clintock Channel polar bear population. However, the HSUS expressed concern that Canada failed to recognize the downward population trend of the M'Clintock Channel population. It believes this situation reflects on Canada's entire management program, and maintains there is no assurance that any of Canada's polar bear populations are being managed sustainably. The MMC recommended that Canada use more conservative population estimates in setting quotas and conduct more frequent, rigorous population assessments, especially for populations where the data is considered “fair” or “poor” in order to ensure that Canada's polar bear populations are being managed sustainably.

Although we have concerns about the M'Clintock Channel population, we disagree that the decline in this population implies that Canada is not managing their polar bear populations sustainably. Canada has a robust management program (see previous Federal Register notices (62 FR 7302 and 64 FR 1529), that is periodically reviewed by the PBTC and the IUCN (World Conservation Union) Polar Bear Specialist Group). There has been considerable discussion of Canada's population management, and Canada continues to look at new models and research data to better manage their polar bear populations. This adaptive management is important because polar bears are characterized by low reproductive potential, long life spans, low density, and wide distribution and are sensitive to harvest rates.

The GNUN emphasizes that the severe decline of the M'Clintock Channel population is not characteristic of Canada's management program and assures us that they are taking steps to correct the system. At the 2001 PBTC meeting, the GNUN presented a new management approach under development that they anticipate will reduce the frequency and impact of population reduction to more acceptable levels. The new approach, based on population viability analysis (PVA), considers the reproduction potential of the population, the uncertainty of the underlying demographic information, and statistical uncertainty when making harvest level determinations. The GNUN anticipates examining options that include scaling back harvest rates in small populations while performing more frequent inventories of larger populations. A systematic integration of traditional knowledge with scientific information through the development of a categorical range of harvest policies that incorporates the perceptions of the hunters is also planned. The GNUN anticipates that the enhanced PVA approach will help them to identify where they need to modify harvest levels, prior to the next population inventory, due to changing environmental conditions or optimistic population estimates.

Table 1 summarizes the polar bear harvest in the M'Clintock Channel population during the 1989/1990 to 1999/2000 harvest seasons. Sport harvest in M'Clintock Channel began in 1991 with no sport hunts conducted from 1992 through 1994. A total of 288 bears were harvested over the past 11 years, ranging from an annual harvest of 17 to 37 bears. Of these bears, 65 (57 male, 7 female, 1 unknown) were sport hunted. As of December 31, 2000, a total of 62 import permits, including for 3 pre-Amendment bears, had been issued for bears sport hunted from this population by U.S. citizens. Since the MMPA was amended in 1994 to allow for the import of certain sport-hunted trophies, the number of bears taken in sport hunts in M'Clintock Channel as a percentage of the total annual harvest has ranged from a low of 29 percent (1994/1995) to a high of 59 percent in 1999/2000.

Conservation Force commented that it was important that the sport-hunting community not be misrepresented or perceived negatively due to the population decline in the M'Clintock Channel and the NWMB related similar concerns from the Native community harvesters. As the NWMB emphasized, the decline was not the fault of the community harvesters as they have consistently adhered to their quotas, including the allocation of bears for sport hunting. As shown in Table 1, the total harvest of polar bears for all purposes did not exceed the annual quota nor did sport hunting increase the number of bears taken annually over the past 10 years.

The GNUN estimates that female bears comprise 65 percent of the current sex ratio of the adult (age 3+) population in M'Clintock Channel. This suggests that the number of adult males has been reduced, so that any continuing harvest will likely be increasingly composed of adult females. Protection of the female component of the population was an important consideration in developing sustainable harvest limits. Any additional take of females will further prolong the recovery time for this population.

The HSUS expressed concern that the reduction in the number of large males in this population may affect the recovery of this population while Conservation Force asserted that sport hunting “* * * has had a minimal or no effect on the population reproduction.” We acknowledge that genetic viability, mate selection, and genetic vigor are not well documented for polar bears, and it is unclear how the reduction of large males affects a polar bear population. It is known that male polar bears are opportunistic breeders and do not contribute to the care of the young. So the loss of a male bear will generally have less of an impact on population recruitment than the loss of a female. Canada's selective harvest of 2 males to 1 female is utilized to conserve the population by reducing the impact of the harvest of females.

We are adopting the emergency interim rule as a final rule without substantive change. The M'Clintock Channel will remain in the list of approved populations in 50 CFR 18.30(i)(1) only for polar bears sport hunted in this population on or before May 31, 2000, the close of the 1999/2000 Canadian hunting season. Any person who hunts in the M'Clintock Channel population between this closure date and the date of any future re-approval of this population will not be able to legally import the polar bear trophy into the United States.

This action was necessary because the CWS provided us with new information for the M'Clintock Channel polar bear population which indicated that the population is severely reduced and harvest quotas have not ensured a sustainable population level. The MMPA requires us to review the best scientific information available; if we receive substantial new information on a population, we must review it and make a new finding as to whether to continue to approve the population. The new information for the M'Clintock Channel population revealed that scientifically sound quotas ensuring the maintenance of the population at a sustainable level are not in place and that terms of the 1973 International Agreement on the Conservation of Polar Bears, that requires the Parties to “manage polar bear populations in accordance with sound conservation practices based on the best available scientific data” are not being met. The information also indicates that, even with remedial steps, the population will not likely recover for some time. We note that information received since the publication of the emergency interim rule is not sufficient to remove our concern that the M'Clintock Channel population has severely declined.

Conservation Force urged that we not do anything to obstruct future re-approval of this population, and the NWMB and SCI recommended that we reinstate the approval of the M'Clintock Channel population as soon as possible. We will continue to work with Canada to receive the most current data on the M'Clintock Channel polar bear population. When substantial new scientific and management data become available that indicate the status of this population has changed, we will review it and make a new finding as to whether the M'Clintock Channel population should be re-approved as a population eligible for the import of sport-hunted trophies.

SCI suggested that we keep the M'Clintock Channel listed as an approved population, subject to the lifting of the moratorium, consistent with the approach of how we initially approved the Viscount Melville Sound population in 1997. We do not agree for the following reasons. There was a 5-year voluntary moratorium on the take of polar bears in the Viscount Melville Sound population. It was lifted effective August 1, 1999, based on recent scientific management information Canada considered “good.” In contrast, the M'Clintock Channel population has severely declined and the GNUN has indicated that any harvest may delay the recovery of this population by more than 22 years. A reduced quota has been set for this harvest season, and the moratorium on harvest is currently in place only for the next season. The co-managers will use the harvest moratorium during next season to continue discussions on what the recovery level should be for this population and whether to allow a small quota during the recovery period.

The MMC agrees with our determination that the M'Clintock Channel population no longer meets the statutory criteria under which imports may be authorized and recommends that the emergency interim rule be adopted as a permanent rule.

The SCI urged that the Gulf of Boothia polar bear population be added as an approved population, based on new mark-recapture data available from the same study period (1998 to 2000) as the M'Clintock Channel. The NWMB also suggested we work together to approve the import of sport-hunted trophies from Nunavut polar bear populations that have not yet been approved. We note that the approval of the Gulf of Boothia or other polar bear populations is not the subject of this rulemaking. You should refer to the February 18, 1997 (62 FR 7302), and January 11, 1999 (64 FR 1529), rules for more information on why these populations were deferred. As indicated in these rulemakings, as future substantial scientific and management data become available on these populations, we will evaluate it to determine whether a proposed rule should be published that would add such populations to the approved list in § 18.30(i)(1). The GNUN presented preliminary results of a 3-year mark-recapture study for the Gulf of Boothia population at the 2001 PBTC meeting. Although they indicated that this population appears to have remained abundant and productive, they recognize, along with the NWMB, that additional collection and analysis of these data are necessary before a more reliable population estimate can be made. The continuation of the mark-recapture study is anticipated to begin as early as spring of 2002. Except for the Gulf of Boothia population, Nunavut shares the other deferred populations with Greenland, another Canadian province, or both. In addition to meeting the other required criteria, joint management agreements will need to be in place before we can consider approval of these populations.

This rule affirms the emergency interim rule that, besides restricting the import of polar bears from the M'Clintock Channel population, updated our regulations at 50 CFR 18.30 to reflect that sport hunting of polar bears is legal in both the NWT and Nunavut Territory and that approved populations may now fall under either the GNWT and/or GNUN jurisdiction. Since the publication of the February 18, 1997 (62 FR 7302), and January 11, 1999 (64 FR 1529), final rules, the Nunavut Territory, formerly part of the NWT, officially joined the Federation of Canada on April 1, 1999. Prior to this, legal sport hunting of polar bears in Canada took place only in the NWT; now the majority of polar bear populations lie within or are shared with Nunavut. All GNWT legislative laws and agreements (including the polar bear management agreements) in place still stand in Nunavut. Inter-jurisdictional management agreements are being drafted or revised to reflect the change in government. Management agreements between participating communities and the GNWT and/or the GNUN (formerly part of GNWT), are still in effect for the approved polar bear populations. Management of polar bear populations now falls under the Department of Resources, Wildlife, and Economic Development (formerly the Department of Renewable Resources), GNWT, and/or the Department of Sustainable Development, GNUN.

The emergency interim rule also announced that Canada has lifted its 5-year harvest moratorium in the Viscount Melville Sound population effective August 1, 1999. This population was added to the list of populations approved for the import of sport-hunted polar bear trophies in our February 18, 1997 (62 FR 7302), rulemaking, subject to the lifting of the harvest moratorium. The current annual harvest quota is set at 4 bears, with 1 female take allowed.

For the reasons given in the emergency interim rule and in this document, we are adopting the substance of the emergency interim rule. However, we are making one, non-substantive change to the amendatory language in the emergency interim rule. When the emergency interim rule was published in the Federal Register on January 10, 2001 (66 FR 1901), language in § 18.30(a)(4)(iv) was inadvertently removed due to a formatting error in the text. We are simply adding back to that paragraph language that should not have been deleted.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As this rule is not expected to significantly affect energy supplies, distribution, or use, this action is not a significant energy action and no Statement of Energy Effects is required.

This action also affirms the information concerning the required determinations contained in the emergency interim rule as follows:

In accordance with the criteria in Executive Order 12866, this rule is not a significant regulatory action. The Office of Management and Budget (OMB) makes the final determination under Executive Order 12866.

This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. A cost-benefit and economic analysis is not required. The economic effects of this rule will impact a relatively small number of U.S. sport hunters. Since the trophies are for personal use and may not be sold in the United States, there are no expected market, price, or competitive effects adverse to U.S. business interests, or to any small entity. Some incidental economic benefits received by the travel/airline, taxidermist, and sport-hunting industries are expected to remain unchanged by this interim rule. If an estimated 10 U.S. citizens hunted a polar bear in M'Clintock Channel, Canada, each year at a total cost of $21,000 (US) for each hunt, then $210,000 would be expected to be spent, mostly in Canada. Because the small number of U.S. hunters that hunt for polar bears in M'Clintock Channel, Canada, are the only group affected by this rule, the fact that no commercial activity in bear products is involved, and the effect of such hunts for U.S. outfitters and transportation services is likely to be small, this interim rule is not expected to be a major rule and will not have a significant economic effect.

Although we are amending our import regulations to reflect that bears sport hunted in the M'Clintock Channel population after the close of the 1999/2000 Canadian hunting season will no longer be eligible for import under the 1997 finding which approved this population for multiple harvest seasons, there are 6 other populations, including Viscount Melville Sound, from which U.S. sport hunters will continue to be able to import legally hunted bears. Thus, we expect there will be no substantial loss to U.S. hunters. The revision of our regulations at 50 CFR 18.30 to include the new territory of Nunavut will have no economic effect as we are simply updating our regulations to reflect that populations approved for the import of sport-hunted polar bear trophies may now fall under either GNWT and/or GNUN jurisdiction.

This rule will not create inconsistencies with other agencies' actions. Since 1972, responsibility for implementing the MMPA has been split between two federal agencies. Acting on behalf of the Secretary, Department of the Interior, we have been delegated the MMPA authority for several species of marine mammals, including the polar bear. The National Marine Fisheries Service (NMFS) implements the MMPA authority of the Secretary, Department of Commerce, for whales, dolphins, and most pinnipeds (i.e., seals and sea lions). Currently, there are no special provisions in the MMPA for import of sport-hunted marine mammal species other than polar bear. Since the only federal agencies with authority for marine mammals are the NMFS and us, and the NMFS has not been delegated MMPA authority for this species and does not have any comparable action for other marine mammal species, this rule will not create inconsistencies with that agency's actions.

This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. The groups most affected by this rule are the relatively small number of U.S. sport hunters who would have chosen to hunt polar bear in the M'Clintock Channel population in Canada, and a comparatively small number of U.S. outfitters, taxidermists, and personnel who provide transportation services for travel from the United States to Canada. The revision of our regulations at 50 CFR 18.30 to include the new territory of Nunavut will have no effect as we are merely updating our regulations to reflect that populations approved for the import of sport-hunted polar bear trophies may now fall under either Government of Northwest Territories and/or Government of Nunavut jurisdiction. Similarly, the announcement of the lifting by Canada of a harvest moratorium in the Viscount Melville Sound population will also have no effect as this population was previously added to the list of populations approved for the import of sport-hunted polar bear trophies in our February 18, 1997 (62 FR 7302), rulemaking, subject to the lifting of the harvest moratorium.

This rule will not raise novel legal or policy issues. This interim rule is limited to the Service's review of new information obtained from Canada on one polar bear population previously approved for issuance of permits to import polar bear trophies personally sport hunted by U.S. residents. Under section 104(c)(5)(A) of the MMPA, before issuing a permit for the import of a polar bear trophy, we must make certain legal and scientific findings. In a previous rule published in 1997 [62 FR 7302], we put the public on notice that if we receive substantial new information on a population, we would review it and make a new finding, if necessary, after consideration of public comment. After reviewing the new information, we find that the M'Clintock Channel population no longer meets the import requirements of the MMPA. Due to the dramatic change in population status, we used an emergency interim rule to make the changes to our regulations effective immediately. The revision of our regulations at 50 CFR 18.30 to include the new territory of Nunavut will also not raise novel legal or policy issues as we are merely updating our regulations to reflect that populations approved for the import of sport-hunted polar bear trophies may now fall under either GNWT and/or GNUN jurisdiction. Similarly, we are merely announcing Canada's lifting of the harvest moratorium in the Viscount Melville Sound population, a population we previously added to the list of populations approved for the import of sport-hunted polar bear trophies in our February 18, 1997 (62 FR 7302), rulemaking, subject to the lifting of the harvest moratorium.

The Department of the Interior certifies that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). An initial Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. Based upon our analysis of the factors identified above, we have determined that no individual industries within the United States will be significantly affected and no changes in the demography of populations are anticipated. This rule involves the import of polar bear trophies for personal, non-commercial use only, and therefore will have no effect on the commercial fur trade market. Polar bear sport hunting is not allowed within the United States. Therefore, sport hunting of polar bears in Canada can have no effect on polar bear sport hunts in the United States since such hunts are currently prohibited. For these reasons, and those described under the E.O. 12866 required determination above, we have, therefore, determined that the rule will not have a significant economic effect on a substantial number of small entities as defined in the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., and have determined that a small entity flexibility analysis study is not necessary.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act:

This rule does not have an annual effect on the economy of $100 million or more. The economic effects of this rule will impact a relatively small number of U.S. sport hunters. A total of 50 polar bears have been taken in sport hunts from the M'Clintock Channel between 1995 and 1999 with a range of 5 to 16 bears taken per year; approximately 74% of sport hunters are U.S. citizens. The announcement of the lifting by Canada of a harvest moratorium in the Viscount Melville Sound population will have no economic effect as this population was previously added to the list of populations approved for the import of sport-hunted polar bear trophies in our February 18, 1997 (62 FR 7302), rulemaking, subject to the lifting of the harvest moratorium. Since the trophies are for personal use and may not be sold in the United States, there are no expected market, price, or competitive effects adverse to U.S. business interests, or to any small entity. The revision of our regulations to include the new territory of Nunavut will have no economic effect as we are merely updating our regulations to reflect the change in government jurisdiction for populations approved for the import of sport-hunted polar bear trophies.

This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The importation of polar bear trophies is for personal, non-commercial use only. The small benefits gained by U.S. outfitters and transportation services as U.S. hunters travel to Canada will most likely remain unchanged as most sport hunters will simply redirect their hunting efforts from the M'Clintock Channel to one of the 6 other approved populations. The revision of our regulations to include the new territory of Nunavut will have no effect as we are merely updating our regulations to reflect a change in government jurisdiction.

This rule will not have substantial direct effects on the States, in the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. The groups most affected by this rule are the extremely small number of U.S. sport hunters who would have chosen to hunt polar bear in M'Clintock Channel, Canada, and a small number of U.S. outfitters, taxidermists, and personnel who provide transportation services for travel from the United States to Canada. The importation of legally taken sport trophies is still approved for 6 other populations from Canada, including Viscount Melville Sound, and it is anticipated that most sport hunters will simply redirect their hunting efforts to one of the 6 other populations. The revision of our regulations to include the new territory of Nunavut will have no effect as we are merely updating our regulations to reflect a change in government jurisdiction.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501, et seq.):

This rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required. This rule is limited to our review of new information obtained from Canada on one polar bear population that we previously approved for issuance of permits to import polar bear trophies personally sport hunted by U.S. residents. We are revising our regulations to include the new territory of Nunavut merely to reflect a change in government jurisdiction.

This rule will not produce a Federal mandate of $100 million or greater in any year, i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implication assessment is not required. We have determined that the rule has no potential takings of private property implications as defined by Executive Order 12630, for the reasons described under the Executive Order 12866 required determination above.

The emergency interim rule placed the hunting community on immediate notice that our 1997 finding that approved the M'Clintock Channel population for multiple harvest seasons was no longer in effect after May 31, 2000, the end of the 1999/2000 Canadian hunting season. If hunters nonetheless took polar bears from this population after the emergency rule was published, they did so with full notice that the M'Clintock Channel population no longer met the eligibility criteria set out in the MMPA for the issuance of import permits.

In accordance with Executive Order 13132, the rule does not have significant Federalism effects. A Federalism assessment is not required since the rule is limited to the importation of personal sport-hunted polar bear trophies for personal (non-commercial) use, only by the person who sport hunted the trophy.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. This rule is limited to our review of new information obtained from Canada on one polar bear population previously approved for issuance of permits to import polar bear trophies personally sport hunted by U.S. residents. Under section 104(c)(5)(A) of the MMPA, before issuing a permit for the import of a polar bear trophy, the Service must make certain legal and scientific findings. In a previous rule published in 1997 (62 FR 7302), the Service told the public that the findings that approved populations as published in the CFR are aggregate findings applicable in subsequent years. However, it also put the public on notice that if we receive substantial new information on a population, we would review it and make a new finding after consideration of public comment. After reviewing the new information, we found that M'Clintock Channel no longer met the import requirements of the MMPA and amended our regulations to reflect that bears sport hunted in this population after May 31, 2000, the close of the 1999/2000 Canadian hunting season, would no longer be eligible for import under the 1997 finding which approved this population for multiple harvest seasons. Due to the severe reduction in population, we used an emergency interim rule to make the changes to our regulations effective immediately. At the same time, we solicited comments and considered those comments in issuing a final rule.

This regulation does not contain new or revised information for which OMB approval is required under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The information collection associated with Federal Fish and Wildlife permits is covered by an existing OMB approval, and is assigned clearance number 1018-0093, Form 3-200-45, with an expiration date of March 31, 2004. Details of the information collection requirements for the import of sport-hunted polar bear trophies appear at Title 50 of the Code of Federal Regulations, Section 18.30(a). We may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have analyzed this rule in accordance with the criteria of the National Environmental Policy Act. The Department of the Interior has determined that the issuance of this action is categorically excluded under the Department's NEPA procedures in Part 516 of the Department Manual, Chapter 2, Appendix 1.10.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we have evaluated possible effects on Federally recognized Indian tribes and have determined that there are no effects. The rule is limited to our review of new information obtained from Canada on the M'Clintock Channel polar bear population. Polar bear sport hunting is not allowed within the United States. Therefore, sport hunting of polar bears in Canada can have no effect on polar bear sport hunts in the United States since such hunts are currently prohibited.

The following changes to current management measures were recommended by the Pacific Fishery Management Council (Council) at its September 10-14, 2001, meeting in Portland, OR. Pacific Coast groundfish landings will be monitored throughout the remainder of the year, and further adjustments to the trip limits will be made as necessary to stay within the OYs and allocations announced in the 2001 annual specifications and management measures for the groundfish fishery, published in the Federal Register at 66 FR 2338 (January 11, 2001), as amended at 66 FR 10208 (February 14, 2001), at 66 FR 18409 (April 9, 2001), at 66 FR 22467 (May 4, 2001), at 66 FR 28676 (May 24, 2001), at 66 FR 35388 (July 5, 2001), and 66 FR 38162 (July 23, 2001).

To rebuild the canary rockfish stock, which was declared overfished in 2000 (65 FR 221, January 4, 2000), the Council chose to maintain very restrictive canary rockfish trip limits throughout the year. The reduced limits were intended to eliminate direct targeting on canary rockfish. To reduce the incidental catch of canary rockfish, the Council has constrained target fisheries for associated species, and has diverted fishing effort off the continental shelf where canary rockfish are commonly found. Despite these efforts, commercial landings of canary rockfish have been higher than expected through August. Concerns about the incidental catch of canary rockfish have resulted in NMFS deviating from two of the Council’s recommendations and adopting more precautionary measures for trip limit adjustments in the limited entry trawl fisheries.

At the September meeting, the Council recommended no retention of canary rockfish in the limited entry fixed gear and open access fisheries coastwide, but did not address canary rockfish catch in the trawl fisheries. Throughout 2001, the trawl fisheries have been structured to minimize the interception of canary rockfish and NMFS believes that the Council had intended to also further restrict landings of canary rockfish in the trawl fishery. Therefore, consistent with the limited entry fixed gear and open access fisheries restrictions, NMFS will also prohibit the retention of canary rockfish in the limited entry trawl fisheries starting with the October trip limit period. Changes to trip limits for trawl gear fisheries may affect either of the small footrope or large footrope bottom trawl fisheries or the mid-water trawl fisheries.

To allow access to more abundant flatfish stocks, the Council recommended increasing the limited entry trawl gear trip limits for petrale sole taken with small footrope gear from 15,000 lb (16,804) per month to 30,000 lb (13,608 kg) per month, and for large footrope gear from 100 lb ( 45 kg) per trip and 1,000 lb (454 kg) per month to 30,000 lb (13,608 kg) per month, beginning with the October trip limit period. Petrale sole generally move to deep water during the winter months and are not associated with canary rockfish. However, during October some petrale sole may still be found on the continental shelf and a trip limit increase could result in a high incidental catch of canary rockfish. Therefore, NMFS is maintaining the current trip limits for petrale sole through October. During the November and December cumulative periods, NMFS will implement the Council's recommendation of a large and small footrope petrale sole limit of 30,000 lb (13,608 kg) per month.

Dover sole, thornyheads, and sablefish are managed as the “DTS complex.” The best available information indicates that DTS catch in the limited entry trawl fishery has been greater than expected, with Dover sole at 92.0 percent, sablefish at 89.0 percent, and shortspine thornyhead at 79.7 percent of their allocations, through August 31, 2001. To allow fishers access to flatfish stocks without exceeding the Dover sole or sablefish OYs, the Council recommended prohibiting retention of DTS species in the limited entry trawl fishery coastwide starting October 2, 2001.

To account for discard mortality of incidentally caught DTS species in the flatfish fisheries, bycatch rates based on 1999 state logbook data will be used as inseason deductions from remaining DTS allocations. These bycatch rates measure unavoidable associated catch and are based on tows unconstrained by trip limits from 1999 state logbook data. In the petrale sole fishery, rates of 0.8 percent for Dover sole, 5.0 percent for sablefish, and 0.5 percent for shortspine thornyhead will be applied to the landed catch of other flatfish to calculate the amount of incidentally caught DTS species. For the other flatfish fishery, rates of 0.5 percent for Dover sole, 0.12 percent for sablefish, and 0.1 percent for shortspine thornyhead will be applied to the landed catch of other flatfish to calculate the amount of incidentally caught DTS species.

NMFS declared darkblotched rockfish overfished on January 11, 2001(66 FR 2338). Although darkblotched rockfish has a separate ABC and OY, it is managed as part of the minor slope rockfish complex. The best available information indicates that 90.6 percent of the open access and limited entry allocations for darkblotched rockfish had been taken through August. To encourage rebuilding of the darkblotched rockfish stock, while at the same time allowing for modest levels of bycatch in other fisheries, the Council recommended decreasing effort in the directed fishery for minor slope rockfish during the remainder of 2001. As of October 2, 2001, the limited entry trawl and open access gears will be prohibited from taking and retaining, possessing or landing minor slope rockfish north of 40°10′ N. lat. Landings of darkblotched rockfish taken with limited entry fixed gear have been low this year. Therefore, the limited entry fixed gear limits for minor slope rockfish north of 40°10′ N. lat. will continue as previously announced.

Since 2000, the use of mid-water trawl gear has been recommended by the Council as an effective method to harvest widow and yellowtail rockfish above the ocean floor with little incidental catch. The best available information indicates that the catch of widow rockfish in the limited entry trawl fishery was at 66.4 percent and yellowtail rockfish at 74.5 percent of their respective allocations through July. To reduce the likelihood of reaching the widow rockfish OY early and allow for a winter mid-water fishery, the mid-water trawl options for widow and yellowtail rockfish north of 40O10' N. lat. have been restricted to the 1,000 lb (454 kg) per month small footrope limit since July, except for the limit for widow rockfish landed with Pacific whiting which is 2,000 lb (907 kg) per month. To provide fishers access to a widow rockfish mid-water fishery without exceeding the OY before the end of the year, the Council recommended extending the current trip limits through October, then increasing the cumulative limits during November and December. Trip limits for the November to December period will be increased from the scheduled 10,000 lb (4,536 kg) per 2 months to 25,000 lb (11,340 kg) per 2 months.

The incidental catch of canary rockfish is higher during directed fishing for yellowtail rockfish than during directed fish for widow rockfish. Therefore, to discourage directed fishing for yellowtail rockfish because of the associated landing of canary rockfish, the Council recommended a decrease in the scheduled trip limits for yellowtail rockfish during the November to December period. Limits are intended to allow for incidental yellowtail rockfish catch taken by vessels using mid-water trawl gear to harvest widow rockfish, while reducing the incentive for directed yellowtail fishing. For the November through December period, the cumulative 2 month limit for yellowtail rockfish taken with limited entry mid-water trawl gear is decreased from 20,000 lb (9,072 kg) per 2 months to 15,000 lb (6,804 kg) per 2 months.

In keeping with natural catch association patterns and to reduce yellowtail rockfish discards in the flatfish fisheries, trip limits for yellowtail rockfish taken with flatfish in small footrope fisheries were introduced in 2000 (65 FR 45308, July 21, 2000). To allow incidental catch of yellowtail by vessels targeting flatfish with a small footrope, the Council recommended maintaining current trip limits for the remainder of the year. During the November through December period, the limited entry trawl gear trip limit for yellowtail rockfish taken as bycatch with flatfish shall be no more than the sum of 33 percent (by weight) of all flatfish except arrowtooth flounder, plus 10 percent (by weight) of arrowtooth flounder, not to exceed 7,500 lb (3,402 kg) per trip, nor 15,000 lb (6,804 kg) per 2 months.

To allow access to allocations for the healthier flatfish stocks, the Council recommended a trip limit for “other flatfish” taken with small footrope gear in the limited entry trawl fishery of 30,000 lb (13,608 kg) per month starting with the October period. Other flatfish taken with large footrope gear in the limited entry trawl fishery would continue at 1,000 lb (454 kg) per trip. As noted above, the Council's recommended limit for petrale sole taken in the limited entry trawl fisheries, for both small and large footrope gear, was 30,000 lb (13,608 kg) per month. Concerns about the incidental catch of canary rockfish have resulted in NMFS deviating from the Council’s recommendations and adopting more precautionary measures. To minimize the catch of associated rockfish species, including canary rockfish, by vessels directing effort on other flatfish and petrale sole, NMFS will maintain the current small footrope limits of 45,000 lb (20,412 kg) per month for other flatfish, with a sub-limit of 15,000 lb (6,804 kg) per month for petrale sole, and the large footrope limits for petrale sole of 100 lb (45 kg) per trip and an “other flatfish” per trip limit of 1,000 lb (454 kg) during October. NMFS will implement the Council’s recommendation during the November to December period. Therefore, for the November and December period, both the small and large footrope petrale sole limits will be set at 30,000 lb (13,608 kg) per month and the small footrope other flatfish limit will be set at 30,000 lb (13,608 kg) per month. For large footrope gear, a 1,000 lb (454 kg) per trip other flatfish limit will continue to be in effect. As of October 2, 2001, arrowtooth flounder taken in the limited entry trawl fisheries using large and small footrope gear will have a 5,000 lb (2,268 kg) per trip limit and a 30,000-lb (13,608-kg) monthly limit.

The best available information indicates that 90.6 percent of the open access and limited entry allocations for darkblotched rockfish had been taken through August. Concerns about the incidental catch of darkblotched rockfish by vessels directing effort on Pacific ocean perch have resulted in the Council recommending that further taking and retaining, possessing or landing of Pacific ocean perch be prohibited for all limited entry and open access gears for the remainder of the year. NMFS concurs with this recommendation.

Bocaccio rockfish (64 FR 49092, September 10, 1999), along with canary rockfish, have been declared overfished. The Council is developing rebuilding plans for these two species. The 2001 OYs for bocaccio rockfish and canary rockfish were set consistent with the rebuilding plans under development. Throughout the year, the Council has set low trip limits to allow incidental catch of these species in fisheries for healthy stocks while removing the incentive for directed fishing. Despite these conservative measures, the catch of bocaccio and canary rockfish has been higher than expected during 2001. To prevent these overfished species from exceeding their 2001 OYs and hindering rebuilding, the Council recommended prohibiting taking and retaining, possessing or landing of bocaccio rockfish and canary rockfish in the limited entry and open access fisheries (including the exempted gears) coastwide for the remainder of the year. NMFS concurs with this recommendation.

Throughout the year, fishing effort has been diverted off the sea floor of the continental shelf where several overfished species, canary, widow, and bocaccio rockfish, are commonly found. To allow for modest levels of incidental catch of shelf rockfish in the limited entry trawl fishery for flatfish while discouraging targeting of shelf species, the Council recommended a decrease in the cumulative limits for minor shelf rockfish. As of October 2, 2001, the limit for minor shelf rockfish taken in the limited entry trawl fishery north of 40°10′ N lat. will decrease from 1,000 lb (454 kg) per month to 300 lb (136 kg) per month and south of 40°10′ N. lat. from 1,000 lb (454 kg) to 500 lb (227 kg) per month.

NMFS declared bocaccio rockfish overfished in 1999. Concerns about the incidental catch of bocaccio rockfish by vessels directing effort on chilipepper rockfish resulted in the 2001 OY for chilipepper rockfish being set lower than would have otherwise been necessary. Concerns about the incidental catch of bocaccio rockfish resulted in the Council also recommending a decrease in cumulative limits for chilipepper rockfish taken with small footrope trawl from 7,500 lb (3,402 kg) per 2 months to 5,000 lb (2,268 kg) per 2 months for the November through December periods. The Council additionally recommended closing chilipepper rockfish landings for the limited entry fixed gear and open access fisheries starting October 2, 2001. NMFS concurs with this recommendation.

The catch of lingcod in the trawl and fixed gear fisheries during 2001 has been slightly lower than expected. Through July 31, 2001, the landings of lingcod were at 55.8 percent of the OY. In order to provide fishers greater access to the OY for lingcod, the Council recommended an increase in lingcod trip limits. For the month of October, lingcod trip limits for all commercial fisheries coastwide will increase from 400 lb (181 kg) per month to 500 lb (227 kg) per month. To limit effort during the winter spawning season, there will still be no retention of lingcod during November through December in all fisheries coastwide.

Because the nearshore rockfish recreational harvests north of 40°10′ N. lat. have been greater than expected, the Council recommended reducing trip limits to slow the fishery. The scheduled cumulative limits for minor nearshore rockfish taken with limited entry fixed gear and open access were 7,000 lb (3,175 kg) per 2 months, with a limited entry sub-limit of no more than 4,000 lb (1,814 kg) and an open access sub-limit no more than 900 lb (408 kg) of species other than black or blue rockfish. For both limited entry fixed gear and open access, the new nearshore rockfish limits will be 2,000 lb (907 kg) per month, of which no more than 800 lb (363 kg) may be species other than black or blue rockfish effective October 2, 2001. South of 40°10′ N. lat., nearshore rockfish harvest has been relatively slow in 2001. Thus, cumulative limits of minor nearshore rockfish taken with limited entry fixed gear will increase from 2,000 lb (907 kg) per 2 months to 3,000 lb (1,361 kg) per 2 months as of October 2, 2001. As of October 2, 2001, cumulative limits of minor nearshore rockfish taken with open access gear south of 40°10′ N. lat. will also increase, from 1,200 lb (544 kg) per 2 months to 3,000 lb (1,361 kg) per 2 months.

To prevent bocaccio and canary rockfish from exceeding their 2001 OYs and hindering rebuilding, the Council recommended closing directed fishing for all shelf rockfish species.

Effective October 2, 2001, the taking and retaining, possessing or landing of minor shelf rockfish, and of widow and yellowtail rockfish, north and south of 40°10′ N. lat. in the limited entry fixed gear and open access fixed gear fisheries will be prohibited.

The California Fish and Game Commission will meet in early October to discuss recreational catch and management measures for bocaccio and canary rockfish. At this time, the recreational catch of canary and bocaccio rockfish is approaching harvest guidelines. If the Commission determines at that meeting to close recreational fisheries for canary and bocaccio rockfish inside state waters because the harvest guidelines have been reached, NMFS will publish complementary closures for Federal waters in the Federal Register.

NMFS also announces the last cumulative trip limit period in 2001 for the “B” platoon, those limited entry trawl vessels designated (on their limited entry permit) to take their cumulative trip limits 2 weeks out of phase with the rest of the fleet. For vessels in the “B” platoon, the final cumulative period will be from November 16, 2001, through December 31, 2001. For species managed with monthly cumulative limits, vessels in the “B” platoon may take the November and December limits for those species during November 16, 2001, through December 31, 2001. For species for which there are 2 month cumulative limits, vessels in the “B” platoon may take the final 2 month cumulative limit during the final period from November 16, 2001, through December 31, 2001.

For the reasons stated here, NMFS announces the following changes to the 2001 annual specifications and management measures (66 FR 2338, January 11, 2001, as subsequently amended) as follows:

In Section IV, under B. Limited Entry Fishery, and under C. 1. Trip Limits in the Open Access Fishery, Tables 3, 4, and 5 are revised to read as follows.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and at 50 CFR part 679.

The Final 2001 Harvest Specifications and Associated Management Measures for the Groundfish Fisheries Off Alaska (66 FR 7276, January 22, 2001 and 66 FR 37167, July 17, 2001) established the amount of the 2001 BSAI Pacific cod TAC as 188,000 metric tons (mt). Pursuant to § 679.20(a)(7)(i)(A), 3,478 mt was allocated to vessels using jig gear, 88,689 mt to vessels using hook-and-line or pot gear, and 81,733 mt to vessels using trawl gear. The share of the Pacific cod TAC allocated to trawl gear was further allocated 50 percent to catcher vessels and 50 percent to catcher/processor vessels (§ 679.20(a)(7)(i)(B)). The share of the Pacific cod TAC allocated to hook-and-line or pot gear was further allocated as follows: (1) 80 percent to catcher/processor vessels using hook-and-line gear; (2) 0.3 percent to catcher vessels using hook-and-line gear; (3) 18.3 percent to vessels using pot gear; and (4) 1.4 percent to catcher vessels less than 60 ft LOA that use either hook-and-line or pot gear (§ 679.20(a)(7)(i)(C)).

As of September 15, 2001, the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that trawl catcher/processors will not be able to harvest 10,000 mt and trawl catcher vessels will not be able to harvest 14,000 mt of Pacific cod allocated to those vessels under § 679.20(a)(7)(i)(B). Therefore, in accordance with § 679.20(a)(7)(ii)(C), NMFS apportions 24,000 mt of Pacific cod from trawl gear to vessels using hook-and-line or pot gear.

The Regional Administrator has also determined that vessels using jig gear will not harvest 3,000 mt of their Pacific cod allocation by the end of the year. Therefore, in accordance with § 679.20(a)(7)(ii)(C), NMFS is reallocating the unused amount of 3,000 mt of Pacific cod allocated to vessels using jig gear to vessels using hook-and-line or pot gear.

In accordance with § 679.20(a)(7)(ii)(C)(1), 400 mt of the combined reallocation of unused Pacific cod from trawl and jig gear is apportioned to catcher vessels using hook-and-line gear. In accordance with § 679.20(a)(7)(ii)(C)(2), the remaining combined reallocation of unused Pacific cod from trawl and jig gear, 25,600 mt, is apportioned so that catcher/processor vessels using hook-and-line gear will receive 95 percent and vessels using pot gear will receive 5 percent of the reallocation.

The harvest specifications for Pacific cod established in the Final 2001 Harvest Specifications and Associated Management Measures for the Groundfish Fisheries Off Alaska (66 FR 7276, January 22, 2001 and 66 FR 37167, July 17, 2001) are revised as follows: 478 mt to vessels using jig gear, 95,821 mt to catcher processor vessels using hook-and-line gear, 665 mt to catcher vessels using hook-and-line gear, 17,469 mt to pot gear, 30,867 mt to trawl catcher/processors, and 26,867 mt to trawl catcher vessels.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to allow the 2001 TAC of Pacific cod in the BSAI to be harvested constitutes good cause to waive the requirement to provide prior notice or opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(3)(B) and 50 CFR 679.20(b)(3)(iii)(A), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion to allow the 2001 TAC of Pacific cod in the BSAI to be harvested constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is taken under 50 CFR 679.20 and is exempt from OMB review under Executive Order 12866.