Federal regulations implementing the National Cooperative State/Federal Bovine Tuberculosis Eradication Program are contained in 9 CFR part 77, “Tuberculosis” (referred to below as the regulations), and in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication” (UMR), which is incorporated by reference into the regulations. The regulations restrict the interstate movement of cattle, bison, and captive cervids to prevent the spread of bovine tuberculosis. Subpart B of the regulations contains requirements for the interstate movement of cattle and bison not known to be infected with or exposed to tuberculosis. The interstate movement requirements depend upon whether the animals are moved from an accredited-free State or zone, modified accredited advanced State or zone, modified accredited State or zone, accreditation preparatory State or zone, or nonaccredited State or zone.

Under the regulations in § 77.10, cattle and bison that originate in a modified accredited advanced State or zone and that are not known to be infected with or exposed to tuberculosis must meet certain identification, certification, and testing requirements prior to being moved interstate.

We recently published several interim rules that amended the regulations by changing the classification of the States of Texas, California, and New Mexico from accredited free to modified accredited advanced and that delayed compliance with certain provisions of § 77.10 until September 30, 2003. The interim rule that amended the classification of Texas was effective June 3, 2002, and published in the Federal Register on June 6, 2002 (67 FR 38841-38844, Docket No. 02-021-1); in a document published in the Federal Register on December 31, 2002, the compliance date for certain provisions of § 77.10 was extended from January 1, 2003, to September 30, 2003 (67 FR 79836-79837, Docket No. 02-021-3). The interim rule that amended the classification of California was effective and published in the Federal Register on April 25, 2003 (68 FR 20333-20336, Docket No. 03-005-1). The compliance date for certain provisions of § 77.10 was September 30, 2003. The interim rule that amended the classification of New Mexico was effective and published in the Federal Register on July 24, 2003 (68 FR 43618-43621, Docket No. 03-044-1). Again, the compliance date for certain provisions of § 77.10 was September 30, 2003.

The specific provisions of § 77.10 that have a delayed compliance date are:

• The identification of sexually intact heifers moving to approved feedlots and steers and spayed heifers moving to any destination (§ 77.10(b));

• The identification requirements for sexually intact heifers moving to feedlots that are not approved feedlots (§ 77.10(d)); and

• Because identification is required for certification, the certification requirements for sexually intact heifers moving to unapproved feedlots (§ 77.10(d)).

Initially, we delayed the compliance with these requirements for the State of Texas for two reasons. First, the size of the cattle industry in Texas necessitated additional time to implement the identification requirements of the regulations. Second, some cattle that had begun moving through channels prior to the change in Texas' tuberculosis status would not have been identified at their premises of origin. In addition, we subsequently delayed the compliance date in response to comments received on the interim rule that classified Texas as modified accredited advanced and that also solicited comments on the current regulatory provisions of the domestic bovine tuberculosis eradication program. The compliance date was delayed for California and New Mexico to provide equitable treatment for producers in California and New Mexico.

Based on the comments that we received on the interim rule for Texas, it appears that the tuberculosis risk associated with the movement of nonbreeding cattle from modified accredited advanced States or zones through feeder channels to slaughter is low and that identification requirements for certain cattle destined for slaughter may be unnecessary. Therefore, we are considering proposing several changes to the regulations as a result of those comments and are further delaying the date for compliance with the identification and certification requirements of § 77.10(b) and (d) for nonbreeding cattle until March 30, 2004. As stated in the interim rule for Texas, this delay in compliance does not apply to the movement of cattle from the former modified accredited advanced zone in El Paso and Hudspeth Counties, TX.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas Model MD-11 and -11F airplanes was published in the Federal Register on May 15, 2002 (67 FR 34635). That action proposed to require modifying the overhead instrument lighting by relocating the dimmer control unit and revising the wire routing.

Interested persons have been afforded an opportunity to participate in the making of this amendment. The FAA has given due consideration to the comments received.

One commenter states no objection to the proposed AD.

Two commenters express concern about whether relocating the dimmer control unit for the overhead instrument light from its existing location to a better-ventilated area will adequately address the unsafe condition. The commenters note that the proposed AD states that inadequate heat dissipation in the existing location contributed to the overheating and internal component failure of the dimmer control unit. Both commenters question whether the proposed AD is addressing the root cause of the smoke in the flight deck—i.e., the failure of the internal components in the dimmer control unit. The commenters noted that a related AD, AD 98-24-02, amendment 39-10889 (63 FR 63402, November 13, 1998), requires a modification of the dimmer control unit to replace the capacitor in the dimmer control unit with a new capacitor having a higher temperature rating. One of the commenters notes, however, that, even after accomplishment of AD 98-24-02, several operators have reported events involving smoke in the flight deck and failure of the new capacitors. Both commenters question whether adequate research has been done to ensure that relocating the dimmer control unit will preclude the overheating condition that can lead to smoke in the flight deck. One of the commenters states that the airplane manufacturer has informed it that no on-aircraft temperature readings were taken either before or after relocating the dimmer control unit. That commenter requests that such on-aircraft testing be accomplished before the FAA proceeds with this rulemaking action.

We infer that the commenters want us to postpone the proposed rulemaking until further testing and analysis are done to ensure that the proposed action will address the unsafe condition. We concur with the commenters' request and have delayed issuance of this final rule until now. Testing was performed on a Model MD-11 airplane to measure the temperature of the dimmer control unit in the existing and new locations. The dimmer control unit had been modified to incorporate the new capacitor. Internal and external temperatures of the dimmer control unit, including temperature of the new capacitor, were recorded every 10 seconds for an hour and forty minutes. Analysis of the test results revealed that the capacitor in the dimmer control unit was heated to approximately 90 percent of its temperature rating in its old location versus approximately 60 percent of its temperature rating in the new location. These results support the hypothesis that the lack of heat dissipation in the existing location of the dimmer control unit contributes to the overheating condition and capacitor failure; moving the dimmer control unit to the new location should correct this unsafe condition. No change to the final rule is necessary in this regard.

Another commenter states that it does not agree that relocating the dimmer control unit will be effective in preventing the overheating condition. The commenter states that increased ventilation may “fan the flames.” The commenter states that it has developed and tested a modified model of the dimmer control unit, for which the FAA has granted a Parts Manufacturing Approval (PMA). The commenter states that redesign of the circuitry in this modification eliminates the possibility of capacitor overheating. The commenter requests that we consider its modified dimmer control unit as a proposed corrective action.

We do not concur. Testing has shown that, rather than “fanning the flames,” relocating the dimmer control unit to a better ventilated area will ensure that airflow is increased and heat is dissipated more effectively, which will alleviate the overheating condition. The testing described previously supports this action. Further, we recognize that, in order to obtain a PMA to replace or modify a type certificated product, a part is required to meet the airworthiness requirements of the Federal Aviation Regulations (FARs) applicable to the airplane model on which the part is to be installed. The part approved by the PMA must have been subjected to all necessary tests and computations as one method of showing compliance with the applicable airworthiness requirements. However, the airworthiness requirements approval for installing a part approved by a PMA may not address unsafe conditions that are likely to be encountered in service operations. In addition, we require the holder of the type certificate for the subject airplane model to make the necessary design changes to correct an unsafe condition by submitting appropriate design changes for approval and, upon the approval of the design changes, make available the descriptive data covering the changes to all operators of airplanes previously certificated under the type certificate. For these reasons, we cannot mandate a part approved by a third-party PMA to correct an unsafe condition. However, per the provisions of paragraph (b) of this AD, an operator may submit a request for approval of the installation of a modified dimmer control unit, such as the one to which the commenter refers, as an alternative method of compliance (AMOC) with this AD. The request should include adequate data to justify that installation of the modified dimmer control unit will provide an acceptable level of safety. No change to the final rule is necessary in this regard.

One commenter is concerned that the overheating condition and capacitor failures in the dimmer control unit may also occur on other airplane models, such as McDonnell Douglas Model MD-10 and DC-10 airplanes, or on other dimmer control units installed in locations other than the overhead area. The commenter notes that capacitor failures within the dimmer control units on other airplane models have been observed and tracked for identification of the cause. The commenter provides data on these other occurrences.

We have reviewed the data provided by the commenter. These data reveal that capacitor failures in the overhead dimmer control unit on other airplanes do not represent systemic failures, and capacitor failures at other locations on the airplane are not related to overheating and are not systemic failures. No change to the final rule is necessary in this regard.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

After the proposed AD was issued, we reviewed the figures we use to calculate the labor rate to do the required actions. To account for various inflationary costs in the airline industry, we find it appropriate to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The economic impact information, below, has been revised to reflect this increase in the specified hourly labor rate.

There are approximately 195 airplanes of the affected design in the worldwide fleet. The FAA estimates that 74 airplanes of U.S. registry will be affected by this AD, that it will take approximately 4 work hours per airplane to accomplish the actions, and that the average labor rate is $65 per work hour. Required parts will cost approximately $101 per airplane. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $26,714, or $361 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The FAA has received two reports of evidence of heat damage to the reprime impeller area found during a visual inspection of the fuel pumps on certain Boeing Model 747 series airplanes. The heat discoloration of the damaged parts indicates that the fuel pumps were exposed to high temperatures due to frictional heating between pump components. Such conditions within the pumps can create a potential ignition source and auto-ignition of vapors could occur, which could result in fire or explosion in a fuel tank.

A review of design data by the manufacturer revealed that a fuel boost/transfer pump having Hydro-Aire part number (P/N) 60-847-1A has less internal fuel retention capability than other fuel boost/transfer pumps. It was determined that the smaller fuel retention capability of the Hydro-Aire fuel pumps may intensify the frictional heating. Replacement of the Hydro-Aire fuel pumps with the improved pumps will minimize the risk of a potential ignition source in the fuel tank.

The fuel boost/transfer pumps of the reprime impeller area of the Hydro-Aire P/N 60-847-1A on McDonnell Douglas Model DC-10-10, DC-10-10F, DC-10-15, DC-10-30, DC-10-30F (KC10A and KDC-10), DC-10-40, DC-10-40F, MD-10-10F, and MD-10-30F airplanes are similar to those on Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes, Model 747 series airplanes, and Model 757 series airplanes. Therefore, all of these models may be subject to the same unsafe condition.

The FAA has previously issued the following two ADs that concern the fuel boost/transfer pumps on Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes, Model 747 series airplanes, and Model 757 series airplanes:

1. AD 2002-24-51, amendment 39-12992 (68 FR 10, January 2, 2003), applicable all Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes, Model 747 series airplanes, and Model 757 series airplanes, requires revising the Airplane Flight Manual (AFM) to require the flightcrew to maintain certain minimum fuel levels in the center fuel tanks, and, for certain airplanes, to prohibit the use of the horizontal stabilizer fuel tank and certain center auxiliary fuel tanks.

2. AD 2002-24-52, amendment 39-12993 (68 FR 14, January 2, 2003), applicable to all Boeing Model 747-400, -400D, and -400F series airplanes, requires revising the AFM to require the flightcrew to maintain certain minimum fuel levels in the center fuel tanks, and to prohibit the use of the horizontal stabilizer fuel tank. That AD also removes the reference to placards that was specified in the operating limiations required by AD 2002-24-51.

This AD will not affect the current requirements of any of those previously issued ADs.

The FAA has reviewed and approved Boeing Alert Service Bulletin (ASB) DC10-28A241, dated April 24, 2003, which describes, among other things, the following:

• Condition 1—Procedures for reviewing the airplane maintenance records to determine if any fuel boost/transfer pump having P/N 60-847-1A is installed. If the records show that none of the pumps have P/N 60-847-1A, no further action is necessary.

• Condition 2—Procedures for a visual inspection to determine if a pump having P/N 60-847-1A is installed. If the inspection shows that no pump having P/N 60-847-1A is installed, no further action is necessary.

• Condition 3, Option 1a.—Procedures to replace the pump with a new pump, if the records or visual inspection verify that a pump having P/N 60-847-1A is installed and replacement pumps are available.

• Condition 3, Option 2a.—Procedures to deactivate any pump having P/N 60-847-1A if replacement pumps are not available.

• Condition 3, Option 2b.—Procedures to relocate pumps having P/N 60-847-1A, if replacement pumps are not available.

In addition, Appendix A, Recommended Operating Limitations, of the ASB describes certain operating procedures, limitations, and related maintenance actions intended to prevent fuel vapors from coming into contact with a possible ignition source in the fuel tanks.

The accomplishment of certain actions specified in the service bulletin is intended to adequately address the identified unsafe condition.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD requires accomplishment of certain actions specified in the service bulletin described previously, except as discussed below.

The service bulletin recommends a review of the airplane maintenance records to determine if a certain P/N for the fuel boost/transfer pump is installed. This AD requires a general visual inspection to determine the P/N. In lieu of the inspection, a review of the airplane maintenance records is acceptable if the P/N of the pump can be positively determined from that review.

While Option 2.b. of the service bulletin recommends replacement of all relocated pumps within 18 months after issue date of the service bulletin, this AD requires only the relocation of the pumps, or deactivation of the pumps having P/N 60-847-1A per the McDonnell Douglas DC-10 Minimum Equipment List.

Appendix A of the service bulletin contains operating limitations and related maintenance actions for fuel boost/transfer pumps having P/N 60-847-1A that are installed in all locations except those boost pumps located in the aft position of the main tanks. This AD does not specify implementation of the operating limitations and related maintenance actions for boost pumps in the aft position of the main tanks since these pumps are always covered with fuel during takeoff, which prevents heated localized temperatures from occurring within the fuel boost/transfer pump due to frictional heating.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance (AMOCs). Because we have now included this material in part 39, only the office authorized to approve AMOCs is identified in each individual AD.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2003-NM-144-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to PW JT8D-209, -217, -217A, -217C, and -219 series turbofan engines was published in the Federal Register on March 25, 2003 (68 FR 14351). That action proposed to require removal and replacement of protective coating of the 7th and 9th through 12th stage HPC disks and the 8th stage HPC hub, initial and repetitive inspections for corrosion pits and cracks, and removal from service as required in accordance with PW alert service bulletin (ASB) JT8D A6435, Revision 1, dated March 7, 2003.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter requests that the disks inspected using PW ASB JT8D 6435, Revision 1, dated March 7, 2003, as well as all new disks, be tracked by the engine release date recorded on FAA 337 form or equivalent rather than per individual disk inspection dates. The commenter feels that this would significantly reduce the burden on airline records departments, especially for large operators, because the time between the disk inspection and the engine release date is typically not more than a few weeks.

The FAA does not agree. There is no way to ensure that the time between the disk inspection and the engine release date will always be a short or controlled amount of time. Some operators or repair facilities may elect to store disks in their inventory for long periods of time. Unless these disks are preserved using instructions in the ASB, the time in storage must be counted in the accumulation of time to the next inspection because the corrosion protective coatings begin to degrade while in storage without proper preservation. However, if an operator can show that their particular operation will always result in short controlled times between inspection and installation and can demonstrate that an acceptable level of safety is maintained, they may apply for relief in accordance with paragraph (d) of this AD.

After careful review of the available data, including the comment noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 95-11-01, Amendment 39-9235 (60 FR 27023, May 22, 1995), which is applicable to Turbomeca Arriel 1A, 1 A1, 1 A2, 1 B, 1 C, 1 C1, 1 C2, 1 D, and 1 D1 turboshaft engines was published in the Federal Register on March 10, 2003 (68 FR 11342). That action proposed to add additional engine models to the applicability section, to eliminate the installation of modification TU 197 as a terminating action to the repetitive checks, to require additional inspections for engines that have modification TU 197 installed, and to require the replacement of modifications TU 76 and TU 197 with modification TU 202, as a terminating action to the repetitive checks and inspections in accordance with Turbomeca Alert Service Bulletin (ASB) No. A292 72 0150, Update 6, dated September 4, 2000, and Turbomeca ASB No. A292 72 0212, Update 5, dated August 8, 2001. Information that describes procedures for checking for unusual noise during gas generator rundown on engine shutdown and after the last flight of the day may be found in SB No. 292 72 0181, Update 3, dated September 15, 1995.

Since the publication of the NPRM supercedure, 68 FR 11342, dated March 10, 2003, we have learned that these turboshaft engines are also installed on certain Sikorsky S-76 A helicopters. The Sikorsky S-76 A has also been added to the applicability.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The reference in Note 1 to the alternative methods of compliance paragraph in the regulatory language section is corrected from (k) to (j) in this AD.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

On June 20, 2003, the FAA issued an Emergency AD (EAD) 2003-13-51 for the specified MDHI model helicopters that contained interim actions until certain investigations were complete. That EAD reuqires certain checks and inspections of bolt, part number (P/N) 900R3100001-103, replacing the bolt with an airworthy bolt if necessary. That action was prompted by two instances of failure of a bolt.

Since the issuance of that EAD, we have new information that indicates that the pilot check and torque inspection required by the EAD can be limited to certain bolts. We also determined that disassembly and a more detailed inspection of the condition of each bolt is necessary. On July 2, 2003, we superseded EAD 2003-13-51 by issuing EAD 2003-14-51, which requires certain checks and inspections of certain bolts and replacing any bolt with an airworthy bolt if necessary. The EAD also provides terminating action for the requirements of the EAD.

The FAA has reviewed MD Helicopters Service Bulletin SB900-092R1, dated June 30, 2003 (SB), which describes procedures for disassembling and inspecting the bolts.

Since the unsafe condition described is likely to exist or develop on other MDHI helicopters of the same type design, the FAA issued EAD 2003-14-51 to prevent failure of a bolt, loss of a main rotor blade, and subsequent loss of control of the helicopter. The AD requires the following:

• Before further flight, remove, inspect, and reinstall each bolt, unless accomplished previously. If segments do not move freely or a crack is found, replace the bolt with an airworthy bolt before further flight.

• Thereafter, until the terminating action is accomplished, before each start of the engines for each bolt with 400 or more hours TIS, do a visual check. A pilot may perform the visual check.

• If a bolt has shifted upward or if there is no gap between the thrust washer and retainer (the gap indicates that the O ring is intact), before further flight, inspect the bolt.

• At specified intervals, until you accomplish the terminating action, for bolts with 400 or more hours TIS, do a cam lever force inspection on each bolt, without removing the bolt.

• Within 30 days, for bolts with 400 or more hours TIS, disassemble, inspect, and reinstall each airworthy bolt. If a crack, fretting, or corrosion is found, replace the bolt with an airworthy bolt before further flight.

• Before accumulating 400 hours TIS, for each bolt with less than 400 hours TIS, disassemble, inspect, and reinstall each airworthy bolt. If a crack, fretting, or corrosion is found, replace the bolt with an airworthy bolt before further flight.

Doing the required disassembly and inspections of each bolt, P/N 900R3100001-103, constitutes terminating action for the requirements of this AD. The actions must be accomplished in accordance with the service bulletin described previously.

An owner/operator (pilot), holding at least a private pilot certificate, may perform the visual checks required by paragraph (b) of this AD and must enter compliance into the aircraft maintenance records in accordance with 14 CFR sections 43.11 and 91.417(a)(2)(v)). A pilot may perform this check because it is a visual check for a gap or movement of the bolt and can be performed equally well by a pilot or a mechanic.

The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability or structural integrity of the helicopter. Therefore, removing, inspecting, and reinstalling each bolt at the specified time intervals, and replacing any unairworthy bolt with an airworthy bolt is required before further flight and this AD must be issued immediately.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual letters issued on July 2, 2003, to all known U.S. owners and operators of MDHI Model MD900 helicopters. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to 14 CFR 39.13 to make it effective to all persons.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002) which governs the FAA's AD system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. Because we have now included this material in part 39, we no longer need to include it in each individual AD.

The FAA estimates that this AD will affect 32 helicopters of U.S. registry, and the inspections and replacement of a bolt will take approximately 13 work hours per helicopter to accomplish at an average labor rate of $65 per work hour. Required parts will cost approximately $800 per bolt (2 bolts per blade and 5 blades) per helicopter. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $283,040, assuming all bolts are replaced.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2003-SW-33-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Boeing Model 747 series airplanes equipped with General Electric CF6-45 and CF6-50 series engines was published in the Federal Register on January 29, 2003 (68 FR 4398). That action proposed to require an inspection to detect chafing of the fuel line or incorrect clearance between the fuel line and pneumatic duct insulation blanket; a fuel leak check and strut drain test; corrective action if necessary; replacement of the outboard strut fuel line coupling O-rings and retaining rings with new parts; replacement of the pneumatic duct boot with a new part; and, for certain airplanes, installation of a flame arrestor and drain line entry screens.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

Two commenters state that there are typographical errors in two of the service bulletin citations specified in the section in the preamble titled “Explanation of Relevant Service Information.” The first commenter states that the reference to Boeing Service Bulletin 747-28-2155 should be 747-71-2155. The second commenter states that the reference to Boeing Service Bulletin 747-36-2122 should be 747-54-2122. While the FAA agrees with these corrections and acknowledges that the service bulletin citations were incorrect in the proposed AD, that section of the preamble is not restated in the final rule.

One commenter asks that paragraph (e) of the proposed AD be changed, for clarification, to add that the fiberglass fabric pneumatic duct boot is replaced with a new, NOMEX fabric duct boot. We agree and have added the language requested by the commenter to paragraph (e) of this final rule.

The same commenter asks that paragraphs (b) and (f) of the proposed AD be changed, for clarification, to add the term “outboard” to define which strut is affected by those paragraphs. We agree and have added the term requested by the commenter to paragraphs (b) and (f) of this final rule.

One commenter states that it performs the repetitive detailed visual inspections of the pneumatic duct boot at every 1C-check, with replacement of the duct boot if it is damaged. The commenter asks that it be allowed to continue to perform the inspections at every 1C-check, and replace the duct boot only if damaged, instead of replacing the duct boot at the time specified in paragraph (e) of the proposed AD. The commenter asks that its program be included as an alternative method of compliance (AMOC) to the proposed AD, if possible.

We do not agree with the commenter. Early replacement of the original boot configuration with a NOMEX boot is critical to having a reliable seal in place. The flight-hour intervals used for maintenance checks may not ensure replacement of the original boot within 12 months. However, if maintenance records indicate that the original boot has been replaced with the new NOMEX fabric part, it is not necessary to repeat that action. Paragraph (e)(2) of this final rule is a continuing requirement which specifies that whenever a damaged boot of the original boot configuration is found it must be replaced before further flight, or within 5 days following detection if there are no leaks. The commenter may submit substantiating data that support a request for an AMOC per paragraph (i) of this AD. No change to the final rule is necessary in this regard.

Two commenters ask that the compliance time for the repetitive replacement of the O-rings and retaining rings, as specified in paragraph (d) of the proposed AD, be changed, as follows: One commenter states that it performs the repetitive replacement of the O-rings and retaining rings every 5 years.

We infer that the commenter wants to continue the replacement every 5 years, in lieu of the compliance time of every 21,000 flight hours or 5 years, whichever is earlier (unless a coupling is disassembled).

The same commenter states that it performs the fuel pressure leak check every 5 years when it replaces the O-rings and retaining rings, and would like to be allowed to continue at that interval in lieu of the 3-year interval specified in Boeing Service Bulletin 747-28-2230, dated September 30, 1999 (referenced in the proposed AD as the source of service information for accomplishment of the fuel leak check and strut drain inspection).

We acknowledge that the service bulletin specified recommends repeating the leak check every 3 years; however, the proposed AD does not require repetitive fuel pressure leak checks; only a one-time check within 12 months after the effective date of the AD.

Another commenter states that it performs the repetitive replacement of the O-rings and retaining rings during its D-check, and asks that all operators be allowed to perform the replacement at that time. The commenter also provides some statistics on cases of fuel leakage found and the corrective actions taken; and noted that there were more fuel leaks that occurred after maintenance of the fuel line coupling O-rings if specially trained mechanics did not do the maintenance, due to the necessity of using delicate installation procedures that are specific to that type of couplings.

We do not agree with the requests to extend the compliance time. The chronological age of the O-rings combined with flight hours produces the deterioration and fuel leaks. With regard to extending the compliance time to allow the replacement to be accomplished at a D-check or every 5 years, we have already considered factors such as operators' maintenance schedules in setting a compliance time for the required replacement and determined that 21,000 flight hours or 5 years, whichever is earlier (unless a coupling is disassembled), is an appropriate compliance time in which the replacement may be accomplished during scheduled airplane maintenance for the majority of affected operators. Since maintenance schedules vary from operator to operator, it would not be possible to guarantee that all affected airplanes could be modified during scheduled maintenance. In any event, we find that the specified compliance time represents the maximum time wherein the affected airplanes may continue to operate without compromising safety. No change to the final rule is necessary in this regard.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. This regulation now includes material that relates to altered products, special flight permits, and AMOCs. Because we have now included this material in part 39, only the office authorized to approve AMOCs is identified in each individual AD. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

The following table provides the cost estimates to accomplish the required actions:

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Airbus Model A319, A320, and A321 series airplanes equipped with certain cockpit lateral fixed windows manufactured by PPG Aerospace was published in the Federal Register on April 11, 2003 (68 FR 17757). That action proposed to require detailed repetitive inspections of the cockpit lateral fixed windows to detect moisture ingression and delamination, and follow-on/corrective actions, as applicable. That action also proposed an optional terminating action for the repetitive inspections.

Interested persons have been afforded an opportunity to participate in the making of this amendment. A single comment which concurred with the proposed AD was submitted.

After careful review of the available data, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed. However, the language in the Summary and the Supplementary Information sections of this preamble has been revised to clarify that “detailed repetition inspections” rather than “a detailed inspection,” are required until the optional terminating action is accomplished.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

After the proposed AD was issued, we reviewed the figures we use to calculate the labor rate to do the required actions. To account for various inflationary costs in the airline industry, we find it appropriate to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The economic impact information below has been revised to reflect this increase in the specified hourly labor rate.

The FAA estimates that 36 Airbus Model A319, A320, and A321 series airplanes of U.S. registry will be affected by this AD, that it will take approximately 2 work hours per airplane to accomplish the detailed inspections to identify moisture ingression of certain identified cockpit lateral fixed windows, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $4,680, or $130 per airplane, per inspection cycle.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, -300, -400, -400D, and -400F series airplanes; and Model 747SR series airplanes; was published in the Federal Register on January 4, 2002 (67 FR 544). For certain airplanes, that action proposed to require repetitive inspections of the clevis bushings on the inboard and outboard sequence carriages of the wing foreflap for bushing migration, and corrective action if necessary; replacement of existing bushings with new bushings, which would terminate the repetitive inspections; and replacement of the bushing markers with new markers, if necessary, to indicate the correct bushing orientation. For certain other airplanes, that action proposed to require a one-time inspection to determine whether the bushings are in the correct orientation, and follow-on actions.

The proposed AD cited Boeing Service Bulletin 747-57-2166, Revision 5, dated May 13, 1993, as the appropriate source of service information for accomplishment of the proposed requirements. Since the proposed AD was issued, Boeing has further revised the service bulletin; however, Revision 6, dated January 16, 2003, adds no new requirements.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One operator disagrees that the proposed AD is necessary or justified. The operator questions the need for additional rulemaking in light of existing regulatory actions that address a similar incident and unsafe condition. The operator notes that inspection of the bushings that are the subject of the proposed AD is also required by AD 92-27-04, amendment 39-8437 (57 FR 59801, December 16, 1992), as corrected (58 FR 8693, February 17, 1993). In addition, the operator considers the incident described in the proposed AD (involving a foreflap separating from and colliding with an airplane in flight) to be the same situation addressed by AD 99-05-02, amendment 39-11051 (64 FR 9906, March 1, 1999). The operator further suggests that the proposed requirement to permanently install markers would subject the markers to considerable wear and, in combination with other related ADs, could have long-term and costly effects on operations and maintenance. Moreover, the operator doubts that incorrect markers would still be installed on airplanes after 8 years in service, asserting that the manufacturer has purged all stocks of incorrect markers.

The FAA does not concur with the request to withdraw the proposed AD. In the incident that led to this rulemaking, the foreflap departed the airplane during flight and collided with the fuselage, resulting in a 51/2-foot by 3-foot hole in the fuselage—despite the prior accomplishment of the requirements of AD 92-27-04 on that airplane. This incident illustrates the danger of large pieces of airplane structure departing the airplane. AD 99-05-02 was issued to correct certain conditions with certain shims and fasteners associated with flap carriages and is not related to the bushing problem addressed by this AD.

Also, the commenter did not provide adequate data to support the claim that no incorrect markers would still be installed on an airplane after 8 years in service. Contrary to the commenter's assertion, Boeing reports that its supply of incorrect markers has not been purged. When Boeing first revised the marker to show the correct orientation, the part number of the new marker was the same as the marker showing the incorrect orientation (part number BAC27EWG-24). Boeing created a new marker with a new part number (BAC27EWG-39). According to Boeing Service Letter 747-SL-57-77, “* * * due to the large numbers of correct BAC27EWG-24 markers already in stock, the BAC27EWG-39 was made an option to the correct BAC27EWG-24 marker. This may have allowed some of the incorrect BAC27EWG-24 markers to be installed.” Therefore, because some markers showing incorrect orientation may still be installed on affected airplanes, the FAA finds it necessary to issue this AD.

One commenter identifies a difference between the applicability of the proposed AD and the effectivity of Service Bulletin 747-57-2166. The proposed AD includes Model 747-400s, which are not listed in the service bulletin. The commenter requests that this disagreement be corrected before the AD is issued.

The FAA acknowledges the disagreement; however, as explained in the proposed AD, Boeing had reported (via Service Letter 747-SL-57-77, dated November 18, 1993) that the subject incorrect markers may also be installed on Model 747-400 airplanes. Model 747-400 airplanes (except the Model 747SP, which has flaps of a different design) are correctly included in the applicability of this AD. No change to the final rule is necessary regarding this issue.

One operator requests that paragraphs (a) and (b) of the proposed AD be revised to clarify the group of airplanes subject to those proposed requirements. Paragraphs (a) and (b), as proposed, identify airplanes with respect to bushing replacement done in accordance with a certain service bulletin. However, for certain airplanes (i.e., those with line numbers after 316), the bushings were installed correctly by means of a production change. The operator concludes that paragraphs (a) and (b), as written in the proposed AD, would have excluded airplanes on which the production change had been completed.

The FAA concurs with the request, for the reasons provided by the commenter. The intent of paragraphs (a) and (b)—as well as (c) and (d)—of this AD is to consider the status of the bushing installation—regardless of the method followed (i.e., the service bulletin or the production change). Paragraphs (a) through (d) have been revised in the final rule to reflect this intent.

One operator requests that the proposed grace period and repetitive inspection interval be revised to correspond to the operator's C-check schedule. The proposed 1,200-flight-cycle interval would not conform to the operator's C-check schedule, so the operator would need to schedule intermediate maintenance to comply with the proposed AD. This commenter suggests that the proposed grace period and repetitive inspection interval be changed to “1,200 flight cycles or 18 months, whichever occurs later,” which would allow the inspections to be accomplished during the operator's regularly scheduled maintenance.

The FAA does not concur. Failure of the clevis lug is flight-cycle-dependent, not time-dependent. Allowing an 18-month interval between inspections for high utilization airplanes would not provide an acceptable level of safety. No change to the final rule is necessary in this regard.

One operator suggests that the Boeing 747 Airplane Maintenance Manual may contribute to the identified unsafe condition because the Boeing overhaul manual (referenced in the maintenance manual) does not specify that the bushings be installed in the orientation specified in the proposed AD. The operator adds that a manual revision would be more effective than an AD in addressing the unsafe condition.

The FAA disagrees. The operator may have been considering a now-obsolete airplane maintenance manual; the most recent version of the maintenance manual specifies the correct installation of the bushing. No change to the final rule is necessary in this regard.

One commenter requests clarification of paragraph (c) of the proposed AD. The commenter questions whether the intent of the requirement is to replace all bushings—whether or not the bushing installation is properly oriented—in accordance with Revision 5 of the service bulletin.

The FAA agrees that clarification of the requirement might be necessary. However, as stated previously, paragraph (c) has been revised in the final rule. The changes made to paragraph (c) of this AD address this commenter's concerns.

Several changes have been made to the proposed AD. Paragraphs (a) and (b) of the proposed AD specify accomplishment of a “general visual inspection.” The FAA has recharacterized this as a “detailed inspection” in the final rule to clarify the type of inspection required; the inspection procedures remain the same. Note 1 in this final rule defines a detailed inspection.

Paragraph (d) of the proposed AD has been retitled “Part Installation” to more accurately identify the requirement. In addition, the text of paragraph (d) has been revised for clarification.

Although the applicability identified in the proposed AD remains the same, the number of airplanes affected by this final rule has been corrected (as specified in the Cost Impact section).

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance (AMOCs). The office authorized to approve AMOCs is identified in paragraph (e) of this proposed AD.

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 731 airplanes of the affected design in the worldwide fleet. The FAA estimates that 137 airplanes of U.S. registry will be affected by this AD, that it will take approximately 7 work hours per airplane to accomplish the required actions, and that the average labor rate is $65 per work hour. The cost of required parts is negligible. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $62,335, or $455 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (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) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Section 1a(5) of the Commodity Exchange Act (Act) defines the term “commodity pool operator” to mean:

[A]ny person engaged in a business that is of the nature of an investment trust, syndicate, or similar form of enterprise, and who, in connection therewith, solicits, accepts, or receives from others, funds, securities, or property, either directly or through capital contributions, the sale of stock or other forms of securities, or otherwise, for the purpose of trading in any commodity for future delivery on or subject to the rules of any contract market or derivatives transaction execution facility,* * *1

Section 4m(1) of the Act 2 provides, in relevant part, that it is unlawful for any CPO, “unless registered under (the Act), to make use of the mails or any means or instrumentality of interstate commerce” in connection with its business as a CPO. Rules 4.5 and 4.13, provide exemptions from CPO registration.

Section 1a(6)(A) of the Act defines the term commodity trading advisor to mean any person who:

If a person is exempt from registration as a CPO or CTA, its associated persons (APs) are not required to register as such. Further, neither the exempt CPO or CTA, nor any of its APs, is required to become a member of a registered futures association.

Generally, CPOs and CTAs who are, or who are required to be, registered with the Commission, must provide prospective pool participants or advisory clients, as the case may be, with a Disclosure Document containing specified information 4 —e.g., the business background of the CPO or CTA and its principals, past performance, fees and other expenses, and conflicts of interest—and they must make and keep specified books and records.5 These CPOs also must provide unaudited periodic financial reports and certified annual reports to participants in their pools.6 Additionally, regardless of registration status, all persons who come within the CPO or CTA definition are subject to certain operational 7 and advertising requirements 8 under part 4, to all other provisions of the Act and the Commission's rules prohibiting fraud that apply to CPOs and CTAs, and to all other relevant provisions of the Act and the Commission's rules that apply to all commodity interest market participants, such as the general antifraud provisions, prohibitions on manipulation and the trade reporting requirements.

On March 17, 2003, the Commission published proposed revisions to Rules 4.5, 4.13, and 4.14 and various other rules under part 4 of its regulations (Proposal).9 The Commission based the Proposal on a prior Rule 4.5 proposal; 10 an Advance Notice of Proposed Rulemaking (ANPR) setting forth additional CPO and CTA registration exemptions submitted by the National Futures Association (NFA) and an additional CPO registration exemption submitted by the Managed Funds Association (MFA); 11 the Commission's Roundtable on CPO and CTA Issues (Roundtable); 12 and generally on its staff's experience in administering part 4 of the regulations (Part 4 Rules).

Specifically, the Commission proposed to amend: (1) Rule 4.5, by deleting from the rule any trading criteria and corresponding disclosure requirement for eligibility for an exclusion from the CPO definition; (2) Rule 4.13, by expanding the availability of existing relief from CPO registration and providing for additional CPO registration exemptions thereunder; (3) Rule 4.14, similarly by expanding the availability of existing relief from CTA registration and providing for additional CTA registration exemptions thereunder; (4) Rules 4.21 and 4.31, by permitting certain communications with prospective pool participants and managed account clients, respectively, prior to Disclosure Document delivery; (5) Rules 4.21 and 4.22, by removing duplicative disclosure and reporting requirements in the “master/feeder fund” context; (6) Rule 4.22, by providing for electronic distribution of Account Statements and Annual Reports; and (7) Rules 4.7, 4.12, 4.13 and 4.22, by conforming the various signature requirements thereof.13

In announcing the Proposal, the Commission stated:

In connection with issuing the Proposal, the Commission also provided temporary no-action relief to Rule 4.5 eligible persons and CPOs and CTAs who met the trading and other criteria specified therein (Temporary No-Action Relief).15 The Proposal required that the Temporary No-Action Relief be claimed by filing a notice with the Commission. The effect of this final rulemaking on claimants under the Temporary No-Action Relief is discussed below.16

The Commission received thirty-one comment letters on the Proposal, as follows: Six from registered CPOs and CTAs; two from registered introducing brokers; two from registered securities investment advisers; one from a registered futures association; one from a futures industry trade association; two from securities industry trade associations; nine from law firms; one from a bar association; one from a certified public accounting firm; and six from retail investors. The majority of these commenters voiced strong support for the Proposal, by such statements as that it would fulfill the Commission's express purposes in making the Proposal, would better harmonize CFTC and Securities and Exchange Commission (SEC) regulation of investment management professionals, and would go a long way toward addressing the issues raised at the Roundtable.17

In light of these comments, the Commission generally is adopting the revisions to the Part 4 Rules that it proposed. Where the Commission is making a change from the Proposal, it discusses the change below.18 In the Federal Register release announcing the Proposal (Proposing Release), the Commission gave a detailed explanation of each rule amendment it had proposed to make.19 Accordingly, the scope of this Federal Register release generally is restricted to the comments received on the Proposal and to the changes to, and clarifications of, the Proposal that the Commission is making in response thereto. The Commission encourages interested persons to read the Proposing Release for a fuller discussion of the purpose of each of the amendments contained in the Proposal.

The significant changes from the Proposal that the Commission is making in the rules it is adopting today are as follows: (1) Rule 4.5 no longer contains a “ marketing” restriction, but it does require disclosure of the fact, and effect, of a claim for exclusion from the CPO definition; (2) Rule 4.13(a)(3) expands the trading limit criterion thereunder to “5 percent” and “100 percent,” from the proposed “2 percent” and “50 percent” limits; (3) Rule 4.13(a)(3) expands the investor eligibility criterion thereunder to “knowledgeable employees” and certain other persons, in addition to “accredited investors,” as proposed; and (4) Rule 4.22 now provides for electronic distribution of Annual Reports, in addition to Account Statements, as proposed, where a CPO furnishes a one-way disclosure notice and the pool participant does not timely object to such distribution.

In addition, the Commission is clarifying: (1) The meaning of the term “aggregate net notional value” in Rule 4.13(a)(3); (2) the effect of this final rulemaking on the Temporary No-Action Relief; (3) the applicability of the Annual Report requirement to CPOs who withdraw from registration in reliance upon Rule 4.13(a)(3) or (a)(4); and (4) in new Appendix A to Part 4, the application of the Rule 4.13(a)(3) trading limit criteria to a broad range of fund-of-fund situations.

The Commission proposed to amend the operating criteria of Rule 4.5 by deleting therefrom provisions concerning commodity interest trading restrictions and related disclosures.20 The Commission explained that the operating criteria of the rule would continue to include the “no marketing” and submission to special calls requirements. The Commission reasoned that “it is appropriate to maintain the marketing restriction because, unlike the case with the proposed CPO registration exemption, members of the retail public may participate in the trading vehicles subject to Rule 4.5.” 21 The Commission nonetheless requested comment on the merits of retaining the “no marketing” criterion—i.e., that a Rule 4.5 qualifying entity “will not be, and has not been, marketing participations to the public as or in a commodity pool or otherwise as or in a vehicle for trading in the commodity futures or commodity options markets.”

In response to this request, one commenter agreed with the proposed retention of the “no marketing” criterion (and with the Commission's rationale therefore) but several commenters disagreed with it. This latter group supported its position with claims that, in the absence of any trading restriction, the “otherwise regulated” nature of the qualifying entities specified in Rule 4.5 would provide adequate customer protection, and, further, that compliance with the subjective nature of the marketing restriction could give rise to the possibility of unequal enforcement where commodity interest trading was restricted.

In light of these comments, the Commission is amending Rule 4.5 such that it no longer contains any restrictions relating either to commodity interest trading or to marketing of the entity. The rule does, however, continue to require disclosure to investors “ now, that the qualifying entity's operator has claimed exclusion from the CPO definition, and that therefore the person is not subject to CPO registration and regulation under the Act. This requirement is set forth in paragraph (c)(2)(i) of the amended rule. The Commission did not propose to change the “special call” provision of Rule 4.5, and, accordingly, the rule continues to contain this provision, in paragraph (c)(2)(ii).22

The disclosure requirement the Commission is adopting today may be satisfied in the same manner that the Commission previously established for the (albeit now deleted) disclosure of commodity interest trading limits under Rule 4.5—i.e.:

At the request of other commenters, the Commission confirms that Rule 4.5 does not affect the ability of a person who has claimed an exclusion from the CPO definition thereunder: (1) To invest in any other trading vehicles—e.g., a commodity pool that engages in unlimited commodity interest trading; and (2) to qualify for an exemption from registration as a CPO under Rule 4.13 in connection with its operation of another trading vehicle that is not covered under Rule 4.5—e.g., a trading vehicle that is not a registered investment company covered under Rule 4.5(b)(1) or a non-pool covered under Rule 4.5(a)(4). This latter confirmation is contained in new Rule 4.5(g), and new Rule 4.13(f) contains a reciprocal provision for CPOs claiming registration relief thereunder. Also, the Commission is discussing below the effect of this rulemaking generally on persons who previously have claimed relief under Rule 4.5.24

The Commission did not propose, and is not now adopting, any other amendments to Rule 4.5. Thus, the proviso to Rule 4.5(c) continues to state that compliance with the operating criteria of the rule:

Various of the new CPO registration exemptions under Rule 4.13 that the Commission is adopting today base eligibility on pool participants coming within the meaning of a term that is defined under the federal securities laws—e.g., that of “accredited investor,”; defined in Rule 501(a) under the Securities Act of 1933 ('33 Act).26 As requested by commenters, by this Federal Register release the Commission confirms that it intends to follow interpretations issued by the SEC and its staff of these definitions and in the event any of these definitions are amended, the Commission will utilize the revised definitions in the applicable Rule 4.13 exemption. However, as the Commission stated in connection with adopting revisions to Rule 4.7 that similarly base relief on certain of these terms:

The Commission proposed new Rule 4.13(a)(3) to provide an exemption from CPO registration where: (1) The pool a person operates engages in a limited amount of commodity interest trading—i.e., by committing no more than 2 percent of the liquidation value of the pool's portfolio to establish commodity interest trading positions, whether entered into for bona fide hedging purposes or otherwise, or where the aggregate net notional value of the pool's commodity interest trading does not exceed 50 percent of the pool's liquidation value; (2) the CPO reasonably believes that each investor in the pool is an “accredited investor”; and (3) the CPO does not market participations in the pool as or in a vehicle for trading in the commodity futures or commodity options markets.28 After explaining how and why this proposal differed from the CPO registration exemption proposal submitted to the Commission by the National Futures Association (NFA) as set forth in the ANPR,29 and after noting the comments received on the ANPR,30 the Commission specifically requested comment on whether under the rule there should be: (1) A higher percentage of assets that may be committed to establish commodity interest positions; and (2) any greater ability to trade commodity interests for bona fide hedging purposes than for non-hedging purposes, including whether there should be any restriction whatsoever on trading for hedging purposes.

Many commenters provided input on proposed Rule 4.13(a)(3). Several of them stated that the proposed trading limits were too low, such that the exemption would be unavailable to many CPOs who should not be subject to the Commission's registration, disclosure, reporting and recordkeeping requirements. One of these commenters recommended that the rule treat bona fide hedging and non-hedging positions alike, claiming that this would simplify trading limit calculations under the rule by avoiding the need to determine whether a particular “risk management position” qualifies as a hedging position, but another commenter recommended that no trading limits should be applicable to the CPO of a pool that trades commodity interests solely for hedging purposes. Two commenters urged that the rule should permit a limited number of non-accredited investors, such as “knowledgeable employees.” Commenters also requested clarification on the meaning of the term “aggregate net notional value”; on whether security futures products (SFPs) are included in the Rule 4.13(a)(3) trading limit tests; and on whether, to qualify for relief under Rule 4.13(a)(3), a CPO must operate its pool pursuant to an exemption from registration under the '33 Act, as a “privately-offered” pool.31

In response to these comments, and in light of its own further deliberations on proposed Rule 4.13(a)(3), the Commission is making various changes from the Proposal in the final rule. Specifically, Rule 4.13(a)(3) as adopted requires: (1) That interests in the pool for which a CPO is seeking to claim relief thereunder must be exempt from registration under the “33 Act and may not be marketed to the public in the United States (U.S.) (paragraph (a)(3)(i)); (2) that the pool may not commit more than 5 percent of assets to establish commodity interest positions or have a notional value of its commodity interest positions that exceeds 100 percent of the pool's liquidation value (paragraphs (a)(3)(ii)(A) and (a)(3)(ii)(B), respectively); 32 and (3) that the pool may include, as proposed, participants who are “accredited investors,” and in addition, certain family trusts formed by accredited investors; “knowledgeable employees;” and persons who are QEPs under Rule 4.7(a)(2)(viii)(A) (paragraph (a)(3)(iii)).33

Further, Rule 4.13(a)(3) as adopted now clarifies that: (1) At all times the pool must meet one or the other of the specified trading limits (paragraph (a)(3)(ii)); (2) security futures products are included in each test (paragraph (a)(3)(ii)); (3) the notional value of an option contract must reflect an adjustment for the delta of the contract (paragraph (a)(3)(ii)(B)(1)); and (4) contracts may be netted by underlying commodity and across designated contract markets, registered derivatives transaction execution facilities and foreign boards of trade (paragraph (a)(3)(ii)(B)(2)).

Most of the commenters on proposed Rule 4.13(a)(3), and in fact, on the Proposal as a whole, expressed concern over the application of the Rule 4.13(a)(3) trading limits in the “fund-of-funds” context.34 They requested the Commission to confirm in its final rulemaking statements it had made in the Proposal on this issue.35 They also presented numerous scenarios involving “fund-of-funds” structures for the Commission to consider.

To address these concerns, the Commission is adopting today Appendix A to Part 4. The introductory text explains that:

In adopting Appendix A, the Commission has been guided by the following principles, i.e., that relief under Rule 4.13(a)(3) should be available where:

(1) The CPO of each investee fund is either: (i) Itself claiming exemption from CPO registration under Rule 4.13(a)(3); or (ii) a registered CPO that is complying with the trading restrictions of Rule 4.13(a)(3). In this regard, the CPO of the investor fund should be able to rely upon the representations of the investee fund CPOs to the foregoing effect.

(2) The CPO of an investor fund has actual knowledge of the trading and commodity interest positions of the investee funds (e.g., where the investee funds are operated by the CPO or one or more affiliates of the CPO). In this case the investor fund CPO may aggregate the commodity interest positions across the investee funds to determine compliance with the trading restrictions of Rule 4.13(a)(3).

(3) An investor fund does not trade commodity interests directly, and the CPO has allocated no more than 50 percent of the investor fund's assets to investee funds that trade commodity interests (regardless of the level of commodity interest trading engaged in by those investee pools). The investor fund CPO may claim exemption under Rule 4.13(a)(3) because the investor fund's exposure to the futures markets may be said to be comparable to that of a stand-alone pool that meets the aggregate net notional value test.

(4) An investor fund engages in direct commodity interest trading in addition to its allocation of assets to investee funds, provided the CPO treats the assets committed to direct trading as a separate pool with its own liquidation value and applies the trading restrictions of Rule 4.13(a)(3) to that “separate pool.”

The Commission proposed new Rule 4.13(a)(4) to provide an exemption from CPO registration where: (1) Interests in the pool for which the CPO seeks to claim relief (a) are exempt from registration under the Securities Act of 1933, and (b) are offered and sold without marketing in the United States (U.S.); and (2) the CPO reasonably believes that (a) natural person participants are QEPs under Rule 4.7(a)(2), and (b) non-natural person participants are QEPs under Rule 4.7 or “accredited investors.” 36 After explaining how and why this proposal differed from the CPO registration exemption proposal submitted to the Commission by the MFA, as set forth in the ANPR,37 the Commission requested comment on what investor qualifications would be appropriate under proposed Rule 4.13(a)(4) and whether all natural person QEPs should be included for purposes of the rule.

The comments received in response to this request were mixed, with some stating that the proposed investor eligibility qualifications would be appropriate, yet others claiming that the proposal was unnecessarily restrictive and that the rule should include all natural person QEPs—i.e., natural persons who are QEPs under either Rule 4.7(a)(2) or (a)(3). Inasmuch as Rule 4.13(a)(4) does not contain any trading limits whatsoever, and the operators in question are not “otherwise regulated”, the Commission is not persuaded by this latter set of comments and, accordingly, it is adopting the rule as proposed.

As an alternative to the foregoing registration exemption proposals for certain CPOs, and to various registration exemption proposals for certain CTAs under Rule 4.14, the Commission sought comment on adoption of a notice registration scheme that would be comparable to the proposed exemption approach with respect to information required to be filed with the Commission and compliance with Part 4 requirements.38 Specifically, the Commission asked for comment on whether a notice registration scheme could make it more clear to the public and other regulatory authorities that this group of CPOs and CTAs remained subject to the CFTC's jurisdiction under the Act, the Bank Secrecy Act and other statutes, while providing the same amount of regulatory relief as the proposed exemption.

The Commission received several comments in response to this request, each of which recommended that the Commission not adopt a notice registration scheme. The arguments advanced to the Commission were that such a scheme: (1) Might confuse prospective pool participants into thinking that a notice registrant was subject to more oversight and regulation than it actually would be; 39 (2) was unnecessary because CPOs exempt from registration remain subject to CFTC jurisdiction, which includes the antifraud provisions of the Act and the Commission's rules; and (3) would not improve the information available to the Commission but, rather, would raise recordkeeping, supervision and audit requirement issues for all concerned. In light of these comments, the Commission is not adopting a notice registration scheme.

As proposed and as adopted, new Rule 4.14(a)(8)(i)(D) provides CTA registration relief for advisors to commodity pools that meet the requirements of the new CPO registration exemptions based on, among other things, trading limits, as discussed above.40 Several persons have asked whether the Commission intends that this CTA registration exemption will define the term “primarily” as used in section 4m(3) of the Act,41 which also provides an exemption from CTA registration, for any CTA that—

The Commission does not intend that the CTA registration exemption in Rule 4.14(a)(8)(i)(D) have any bearing whatsoever on the meaning of the term “primarily” in section 4m(3). Rather, the Commission intends to employ the criteria of Rule 4.14(a)(8)(i)(D) solely for the purposes of the rule itself.42

As the Commission explained in the Proposing Release, the single “persons” specified in Rule 4.14(a)(10) for the purposes of section 4m(1) of the Act are patterned after the single “clients” specified in Rule 203(b)(3) under the IAA.43 By this release, and at the request of a commenter, the Commission confirms that it intends to follow interpretations of Rule 203(b)(3) issued by the SEC and its staff. As stated above in connection with the discussion of Rules 4.13(a)(3) and 4.13(a)(4), however, the Commission has the right to provide its own interpretations concerning the counting of single “persons,” if such action is found to be necessary to effectuate the Act and the Commission's regulations, and, further, the Commission expects that it would exercise this right infrequently.44

Commission Rules 4.21 and 4.31 respectively require CPOs and CTAs to provide a Disclosure Document to their prospective pool participants and advisory clients. The Commission proposed to amend these rules to provide that the Disclosure Document must be delivered by no later than the time a CPO delivers a subscription agreement for the pool for which it is soliciting or a CTA delivers an advisory agreement for the trading program for which it is soliciting.45 To ensure achievement of the purpose of the Disclosure Document—i.e., that prospective investors are fully informed about all material facts before committing their funds—, and consistent with the Roundtable comments, these proposed rule amendments would have been subject to the proviso that “any material distributed in advance of the delivery of the Disclosure Document is consistent with or amended by the information contained in the Disclosure Document and with the obligations of the [CPO or CTA] under the Act, the Commission's regulations issued thereunder, and the laws of any other applicable federal or state authority.” (Emphasis added.)

One of the commenters on these proposed rule amendments objected to this proviso, claiming that the phrase “or amended by” could be read to mean that information does not have to be consistent with the Disclosure Document at the time the information is distributed, as long as it is corrected when the Disclosure Document is delivered. To avoid any such misunderstanding, Rules 4.21(a) and 4.31(a) as adopted now further provide that:

Another commenter on these proposed rule amendments asked for clarification on the permissibility of distributing performance materials in advance of delivery of a Disclosure Document. In response, the Commission states that performance information may be distributed in advance of the Disclosure Document, provided it is presented in the format specified by the CFTC.46

In connection with adopting these amendments to Rules 4.21 and 4.31, the Commission has reviewed its July 1997 interpretation regarding electronic delivery of CPO and CTA Disclosure Documents (the “1997 Interpretation”) 47 for the purpose of considering whether it should revise certain aspects of that interpretation, such as the requirement that visitors to a CPO or CTA Web site must view a summary risk disclosure statement before they may access performance information. The Commission notes that the 1997 Interpretation was premised on the now obsolete requirement in Rules 4.21 and 4.31 that a Disclosure Document respectively be delivered on or before the date that a CPO solicited, accepted or received funds or other property from a prospective pool participant, or a CTA solicited or entered into an advisory agreement with a prospective client. Accordingly, the provisions of amended Rules 4.21 and 4.31 supercede the 1997 Interpretation.

The Commission is amending Rule 4.22 by adding a new paragraph (i) to the rule to establish that, as proposed, a CPO may distribute periodic Account Statements to pool participants by electronic means, and, in response to favorable comments, a CPO may so distribute Annual Reports.48 Also in response to comments, for greater flexibility the rule as adopted does not specify each and every step a CPO must take to furnish financial information to pool participants. What the rule does require is that prior to transmission of any Account Statement or Annual Report to a pool participant by means of electronic media, a CPO must disclose to the participant that it intends to distribute these documents electronically, absent objection from the participant, which objection, if any, the participant must make no later than 10 business days following its receipt of the disclosure.49

The Commission proposed to amend certain of the part 4 rules that list the CPO and CTA signatories who may sign various required documents.50 As the Commission explained:

The Commission received two comments on these proposed rule amendments. The first comment recommended that the same standard be applied to each situation where documents are required to be executed. The Commission agrees with this comment, and, accordingly, is adopting as the suggested “universal standard” the requirement that part 4 documents be manually executed by “a representative duly authorized to bind” an eligible person, CPO or CTA. Specifically, this requirement is now found in Rules 4.5(f)(2), 4.7(d)(1)(vii), 4.12(b)(3)(vi), 4.13(b)(1)(iii), 4.14(a)(8)(iii)(A)(3) and 4.22(h)(3).

The second comment recommended that the list of permitted signatories be expanded, such that the applicable rules would specifically provide that “any listed principal” is a permitted signatory. The Commission does not agree with this comment, because not all principals of a CPO or a CTA may in fact be duly authorized to bind the CPO or CTA.52

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, holds an approval for NADA 138-934 for use of PENNCHLOR SP 250 and PENNCHLOR SP 500 (chlortetracycline, procaine penicillin, and sulfamethazine) three-way, fixed combination Type A medicated articles to make three-way combination drug Type C medicated swine feeds for use for growth promotion, increased feed efficiency, and the management of several bacterial diseases. This product is subject to the transitional approval provision of section 108(b)(2) of the Animal Drug Amendments of 1968 and is currently subject to interim marketing under § 558.15(g)(1) (21 CFR 558.15(g)(1)). At this time, 21 CFR 558.145 is being amended to reflect this approved application.

We note the drug sponsors designated for this product in § 558.15(g)(1), American Cyanamid Co. and Pfizer, Inc., are incorrect. Likewise, the provision states that the use levels and indications for use for this medicated article are listed in § 558.15(g)(2), but this information was apparently never listed in § 558.15(g)(2).

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs of the waters within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations. Safety zones may be established for safety or environmental purposes. A safety zone may be stationary and described by fixed limits or it may be described as a zone around a vessel in motion. Security zones limit access to prevent injury or damage to vessels, ports, or waterfront facilities. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Timely publication of these rules in the Federal Register is often precluded when a rule responds to an emergency, or when an event occurs without sufficient advance notice. The affected public is, however, informed of these rules through Local Notices to Mariners, press releases, and other means. Moreover, actual notification is provided by Coast Guard patrol vessels enforcing the restrictions imposed by the rule. Because Federal Register publication was not possible before the beginning of the effective period, mariners were personally notified of the contents of these special local regulations, security zones, or safety zones by Coast Guard officials on-scene prior to any enforcement action. However, the Coast Guard, by law, must publish in the Federal Register notice of substantive rules adopted. To meet this obligation without imposing undue expense on the public, the Coast Guard periodically publishes a list of these temporary special local regulations, security zones and safety zones. Permanent rules are not included in this list because they are published in their entirety in the Federal Register. Temporary rules may also be published in their entirety if sufficient time is available to do so before they are placed in effect or terminated. The safety zones, special local regulations are security zones listed in this notice have been exempted from review under Executive Order 12866, Regulatory Planning and Review, because of their emergency nature, or limited scope and temporary effectiveness.

The following rules were placed in effect temporarily during the period from April 1, 2003, through June 30, 2003, unless otherwise indicated.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

This safety zone is established to safeguard the public from the hazards of high-speed boat races. The size of the zone was determined by the race course and using previous experiences of high-speed boat races in the Captain of the Port zones and local knowledge about wind, waves, and currents in this particular area.

The safety zone will be enforced on August 8, 2003 from 9 a.m. until 4 p.m.; on August 9 and 10, 2003 from 9 a.m. until 5 p.m. The safety zone will start at the following coordinates: 43° 02.423′ N 087° 53.167′ W west to 43° 02.422′ N 087° aves\rules.xml 53.442′ W south to 43° 01.583′ N 087° 53.550′ W southeast to 43° 00.533′ N 087° 53.091′ W east to 43° 00.619′ N 087° 52.827′ W north to 43° 01.587′ N 087° 53.244′ W north to ending waypoint 43° 02.423′ N 087° 53.167′ W located inside of Milwaukee Harbor. There will also be a northern zone prohibiting vessel traffic into the racing area at the following position 43° 02.473′ N 087° 52.877′ W to 43° 02.535′ N 087° 53.020′ W to 43° 02.565′ N 087° 53.127′ W to 43° 02.590′ N 087° 53.260′ W. There will also be a southern zone which also provides a lane for recreational vessels into inner Milwaukee Harbor. At the following position 43° 00.490′ N 087° 52.660′ W to 43° 00.429′ N 087° 52.744′ W to 43° 00.373′ N 087° 52.886′ W to 43° 00.343′ N 087° 53.055′ W to 43° 00.508′ N 087° 53.246′ W to 43° 00.597′ N 087° 53.318′ W to 43° 00.911′ N 087° 53.467′ W to 43° 01.100′ N 087° 53.559′ W to 43° 01.218′ N 087° 53.612′ W to 43° 01.311′ N 087° 53.642′ W to 43° 01.378′ N 087° 53.617′ W to 43° 01.504′ N 087° 53.649′ W (NAD 83)

All persons and vessels shall comply with the instructions of the Captain of the Port Milwaukee or his designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Milwaukee or his designated on scene representative. The Captain of the Port Milwaukee may be contacted via VHF Channel 16.

The Coast Guard is establishing a safety zone running between the break walls inside and outside Milwaukee Harbor, Milwaukee, Wisconsin. High-speed vessels will be transiting the inner harbor on Friday August 8, 2003 to tune their engines and become familiar with the race course. Due to other vessel traffic there will be times that when the high-speed vessels will not be transiting the area so other vessels may transit this area. On August 9 and 10, 2003 the races will occur. There will be breaks between races for other vessels to transit in and out of the harbor. The Coast Guard will notify the public, in advance, by way of Ninth Coast Guard District Local Notice to Mariners, marine information broadcasts, and for those who request it from Marine Safety Office Milwaukee, by facsimile (fax).

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities: the owners or operators of vessels intending to transit or anchor in the vicinity of the inner and outer Milwaukee Harbor on August 8, 2003 from 9 a.m. until 4 p.m. and again on August 9 and August 10, 2003 from 9 a.m. until 5 p.m.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only one hour on one day and late in the day when vessel traffic is minimal. Vessel traffic may enter or transit through the safety zone with the permission of the Captain of the Port Milwaukee or his designated on scene representative. Before the effective period, we will issue maritime advisories widely available to users of the Port of Milwaukee.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Milwaukee (See ADDRESSES.)

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2. of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Commandant Instruction M16475.1D, from further environmental documentation.

On June 16, 2003 we published a notice of proposed rulemaking (NPRM) for this regulation (68 FR 35615). The permit application was received such that we could receive public comment on the proposed rule. However, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days from the date of publication. The permit application did not allow sufficient time for publication of an NPRM followed by a temporary final rule effective 30 days after publication. Any delay of the effective date of this rule would be contrary to the public interest by exposing the public to the known dangers associated with fireworks displays and the possible loss of life, injury, and damage to property.

This safety zone is established to safeguard the public from the hazards associated with launching of fireworks inside Milwaukee Harbor. The size of the zone was determined by using previous experiences with fireworks displays in the Captain of the Port Milwaukee zone and local knowledge about wind, waves, and currents in this particular area.

This rule is effective from 9:50 p.m. (CST) on August 30, 2003 until 10:15 p.m. (CST) on September 1, 2003. The safety zone will encompass all waters and adjacent shoreline bounded by the arc of the circle with a 1680-foot radius with its center in approximate position 43° 02.16′ N, 087° 53.18′ W. These coordinates are based upon North American Datum 1983 (NAD 83).

All persons and vessels shall comply with the instructions of the Captain of the Port Milwaukee or his designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Milwaukee or his designated on scene representative. The Captain of the Port Milwaukee may be contacted via VHF Channel 16.

We received no comments for this rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities: the owners or operators of vessels intending to transit or anchor in the vicinity of outer Milwaukee Harbor from 9:50 p.m. (CST) until 10:15 p.m. (CST) on August 30 and 31, 2003. And again on September 1, 2003 in the event of inclimate weather.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only one hour on one day and late in the day when vessel traffic is minimal. Vessel traffic may enter or transit through the safety zone with the permission of the Captain of the Port Milwaukee or his designated on scene representative. Before the effective period, we will issue maritime advisories widely available to users of the Port of Milwaukee.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Milwaukee (See ADDRESSES).

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local government and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34), of the Instruction, from further environmental documentation.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and (d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and for making the rule effective less than 30 days after publication. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

This Safety Zone is established to safeguard the vessel and the public. The size of the zone was determined by the necessities of safe navigation in the Captain of the Port (COTP) zone and local knowledge about wind, waves, and currents in this particular area.

The safety zone is effective from 12:01 a.m. (CST) on August 6, 2003 until 11:59 p.m. (CST) on August 10, 2003. This rule will be enforced when the RED WITCH, PRIDE of BALTIMORE II, LARINDA, TRUE NORTH, NINA, HMS BOUNTY, and FAIR JEANNE are underway, on Lake Michigan in the COTP Milwaukee zone, and are within 3 nautical miles of shore. This zone will be a moving safety zone.

The Coast Guard will implement a safety zone around the sailing vessels RED WITCH, PRIDE of BALTIMORE II, LARINDA, TRUE NORTH, NINA, HMS BOUNTY, and FAIR JEANNE in vicinity of Kenosha, WI. Vessels are not to come within 100 yards of the sailing vessels RED WITCH, PRIDE of BALTIMORE II, LARINDA, TRUE NORTH, NINA, HMS BOUNTY, and FAIR JEANNE while they are underway for the purposes of safe navigation for the sailing vessels as well as other vessels. The Coast Guard will notify the public, in advance, by way of Ninth Coast Guard District Local Notice to Mariners, marine information broadcasts, and for those who request it from Marine Safety Office Milwaukee, by facsimile (fax).

All persons and vessels shall comply with the instructions of the Captain of the Port Milwaukee or his designated on-scene representative. Entry into, transiting through, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Milwaukee or his designated on scene representative. The Captain of the Port Milwaukee may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This determination is based on the minimal time that vessels will be restricted from the zone and that the zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the zone's activation.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities: The owners or operators of vessels intending to transit or anchor in the vicinity of the sailing vessels RED WITCH, PRIDE of BALTIMORE II, LARINDA, TRUE NORTH, NINA, HMS BOUNTY, and FAIR JEANNE, while underway on Lake Michigan, from 12:01 a.m. (CST) on August 6, 2003 until 11:59 p.m. (CST) on August 10, 2003.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be enforced for only a few hours to safeguard the navigation of the boating public and the navigation of the RED WITCH, PRIDE of BALTIMORE II, LARINDA, TRUE NORTH, NINA, HMS BOUNTY, and FAIR JEANNE, while the vessels are underway on Lake Michigan. In addition, commercial vessels transiting the area can transit around the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect. Vessel traffic may enter or transit through the safety zone with the permission of the Captain of the Port Milwaukee or his designated on scene representative.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Milwaukee (See ADDRESSES.)

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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.

We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2. of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Commandant Instruction M16475.1D, from further environmental documentation.

The Coast Guard is implementing the permanent safety zones in 33 CFR 165.909 (24) and (25) (67 FR 44560, July 3, 2002), for fireworks displays in the Captain of the Port Milwaukee Zone during August 2003. The following safety zones are in effect for fireworks displays occurring in the month of August 2003:

Location: All waters and adjacent shoreline off the Sturgeon Bay Yacht Club, Sturgeon Bay Canal encompassed by the arc of a circle with a 350-foot radius of the fireworks launch platform with its center in approximate position 44° 49.33′ N, 087° 23.27′ W (NAD 1983), on August 2, 2003, from 8:45 p.m. until 9:30 p.m. This safety zone will temporarily close down the Sturgeon Bay Canal.

Location: All waters and adjacent shoreline off the southeast side of the Menominee Municipal Marina, Lake Michigan, encompassed by the arc of a circle with an 840-foot radius of the fireworks barge with its center in approximate position 45°20.05′ N, 087°36.49′ W (NAD 1983), on August 9, 2003, from 9:30 p.m. until 10 p.m.

You may be potentially 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:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0127. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under 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__00/ Title__40/40cfr180_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

In the Federal Register of September 21, 2001 (66 FR 48677) (FRL-6798-3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PF-1043) by Platte Chemical Company, 7251 4th Street, Greely, CO 80632. This notice included a summary of the petition prepared by the petitioner Platte Chemical Company.

The petition requested that 40 CFR 180.1208 be amended by establishing a temporary tolerance for residues of the plant growth regulator 2,6-DIPN, in or on potatoes at 3 parts per million (ppm) for the peels, 0.5 ppm for potato (whole). The tolerance will expire on May 31, 2006. EPA received comments on this petition submitted by John Forsythe, General Manager, on behalf of D-I-1-4, Inc. (Meridian, ID). The issues raised by Mr. Forsythe related to the following: (1) The classification of 2,6-DIPN as a biochemical pesticide; (2) the lack of chronic toxicity data; and (3) the public's exposure to this chemical through its use as an industrial chemical. Mr. Forsythe's comments are discussed individually below, along with EPA's response.

Comment 1. Mr. Forsythe requested that the Agency re-evaluate the biochemical classification determination for 2,6-DIPN and provide any publicly available information regarding the natural occurrence of 2,6-DIPN in any food source.

EPA Response. A biochemical pesticide, by definition, is a naturally occurring substance which controls target pests by a non-toxic mode of action. However, there are products that are not naturally occurring, yet they are registered by the Agency as “biochemical-like,” insofar as data requirements are concerned. Thus, while 2, 6-DIPN, is synthetic and does not occur naturally in any food or non-food plants, it is structurally similar to three compounds (1-isopropyl- 4,6-dimethylnaphthalene, 1-methyl-7-isopropylnaphthalene, and 4-isopropyl-1,6-dimethylnaphthalene) that occur naturally in potatoes, and 2,6-DIPN is functionally identical to the naturally occurring plant growth regulator in potatoes.

Comment 2. Mr. Forsythe expressed concern that the Agency had not presented any public documentation demonstrating that the mode of action of 2,6-DIPN is non-toxic.

EPA Response. The new active ingredient, 2,6-DIPN, is a plant growth regulator (PGR) intended to inhibit sprouting in stored potatoes. PGRs may stimulate or retard ripening, maturity of whole plants and/or fruits, enhance growth, yield, enhance or counteract the activities of other PGRs, and/or change plant architecture (amongst other processes). PGRs are not toxic to the target plant, especially at the application rate. Tests conducted during the experimental use permit showed no toxicity to potatoes. None of these actions are directly lethal to the plants upon which they are applied, which supports a determination that 2, 6-DIPN operates through a non-toxic mode of action. Diisopropylnapthalene is similar in molecular structure, and functions as three sprout inhibiting compounds naturally occurring in potatoes (1-isopropyl-4,6-dimethylnaphthalene, 1-methyl-7-isopropylnaphthalene, and 4-isopropyl-1,6-dimethylnaphthalene). The three compounds found in potatoes and 2,6 DIPN are all isopropyl napthalene, a sprout inhibitor in a manner comparable to natural PGRs found in potato plants (as described above). In addition, acute toxicity studies conducted on animals indicated Toxicity Category IV for all routes of exposure and chronic studies were not triggered following the data requirements for biochemical pesticides as given in 40 CFR 158.690(c). EPA therefore has concluded that its mode of action can be classified as “non-toxic.”

Comment 3. Mr. Forsythe expressed concerns regarding dietary intake of 2,6-DIPN, due to: (1) The synthetic nature of the compound; and (2) the lack of toxicity information to support an assessment of dietary exposure to 2,6-DIPN.

EPA Response. As discussed in the previous response, the data support the classification of 2,6-DIPN as a biochemical, based on its structural similarity to naturally occuring PGRs. In addition, the registrant has conducted a series of toxicity tests according to the requirements listed in 40 CFR 158.690, in support of experimental use permits (EUPs) and for product registration. Dietary exposure estimates were based on the assumption that 100% of the crop will be treated, and other worst-case assumptions were applied to overestimate the typical dietary exposure likely under normal conditions of use.

A 90-day oral toxicity study (MRID 450493-01) demonstrated that rats did not exhibit immune system effects, demonstrated by no changes in spleen or thymus weights and absence of lesions in spleen, thymus, and lymph nodes. The 90-day oral no observable adverse effects level (NOAEL) was 100 milligrams/kilogram/day (mg/kg/day), and the lowest observable adverse effects level (LOAEL) was 200 mg/kg/day, based on decreased body weight gain and food consumption. In a developmental toxicity study (MRID 4500010-01) in rats, the test animals did not exhibit increased fetal susceptibility to 2,6-DIPN when compared to untreated animals. The prenatal developmental toxicity NOAEL was 150 mg/kg/day and the LOAEL was 500 mg/kg/day, based on decreased fetal body weight and a possible treatment-related cartilage anomaly.

The toxicity data on 2,6-DIPN does not indicate extra sensitivity of offspring when compared with that of adult animals, but the data base does not represent a complete assessment of potential age-related sensitivity or acute effects other than lethality. The absence of a developmental toxicity study in a second species, a multigeneration reproduction toxicity study, or a range of doses adequate to induce a full range of toxic responses, especially potential acute effects in any of the available studies, required that the FQPA 10-fold safety factor be retained in defining EPA's level of concern.

Studies submitted to test the potential genotoxicity or mutagenicity of 2,6-DIPN included a reverse mutation (Ames) assay (MRID 446141-11), an unscheduled DNA synthesis assay in rat primary hepatocytes (MRID 446141-10), and a mouse micronucleus assay (MRID 446141-12); all of these were negative. A mouse lymphoma assay (MRID 454388-01) was positive at higher concentrations for mutagenicity, but since 2,6-DIPN was cytotoxic (killed the test cells) at the those concentrations where the positive results occurred (with and without metabolic activation), the test results are considered as being equivocal, or falsely positive. As a group, these four studies demonstrated that 2,6-DIPN is not a mutagen.

Information supplied by the commenter (Ref. 5) noted that “Di-Isopropylnaphthalene(s) contained no chemical groups that would be structurally alerting for potential mutagenicity.” Additionally, in spite of the equivocal study (MRID 454388-01), “there was no evidence for a mutagenic effect in other in-vitro mutagenicity tests or in an adequately performed in vivo micronucleus assay in mice. The Committee agreed that no further mutagenicity testing was required.”

Based on the absence of effects on the immune system in the 90-day subchronic study, no effects on developing rats at doses below those causing maternal effects, and no genetic toxicity, Tier II and Tier III toxicity data requirements were not triggered. The Agency does not require any additional toxicity studies at this time although a livestock feeding study must be conducted as a condition of registration (see EPA Response to Comment 4).

Comment 4. Mr. Forsythe stated that, in the absence of any chronic toxicity data, “it would be inappropriate to disregard the safety factor” (referring to the FQPA 10-fold margin of safety to account for effects on sensitive populations, such as infants and children), and that “threshold effects cannot be fully determined, and a safety factor would seem appropriate to address this lack of a complete data set regarding dietary exposure and chronic toxicity.”

EPA Response. As stated above, the Agency has retained the FQPA safety factor in its assessment of the dietary exposure to 2,6-DIPN.

Comment 5: Mr. Forsythe stated that the Agency should consider non-dietary and non-occupational sources of human exposure to 2,6-DIPN. The commenter submitted an EPA document (Ref. 5), in which 2,6-DIPN is described as an “emerging pollutant” in Lake Michigan. The document also states that polychlorinated biphenyl (PCB) substitute compounds (which include 2,6-DIPN), are “detected in effluent, sediment, and fish in the basin; bioaccumulative and toxic.”

Additionally, the commenter provided information that European governments have expressed concerns regarding public exposure to DIPNs via the paper industry. In studies conducted by the United Kingdom Joint Food Safety and Standards Group (JFSSG), it was determined that DIPNs could be present in recycled food packaging and in packaged food (Ref. 5). DIPNs were detected in 30 of 34 samples of retail packaging at up to 44 mg/kg, and in 6 of 10 food samples at 0.04-0.89 mg/kg.

EPA Response. Section 408(b)(2)(A)(ii) explicitly requires the Agency to find that “there is a reasonable certainty that no harm will result from aggregate exposures, including all anticipated dietary exposures and all other exposures for which there is reliable information.” (emphasis added). As discussed below, EPA has considered all available information on non-dietary and non-occupational exposures in establishing this temporary tolerance.

EPA reviewed the LaMP study (Ref. 5), and found that these “emerging pollutants” were only included in a list of chemical stressors in the lake “as a precautionary measure, either because of their widespread use in the basin, the fact that these chemicals are beginning to show up in monitoring data, or both.” The list of emerging pollutants listed includes: Mineral and silicone oils, di(2-ethylhexyl)phathalate (DEHP), isopropylbiphenyls, diphenylmethanes, butylbiphenyls, dichlorobenzyldichlorotoluene, phenylxylyl ethane, and diisopropylnaphthalene. The article does list PCB substitute compounds as being “detected in effluent, sediment, and fish in the basin; bioaccumulative and toxic” (Ref. 5). According to the Michigan LaMP (Ref. 5), “Following the 1979 restrictions on PCB use, [these] compounds began being used in dielectric fluids, hydraulic system lubricants, and in solvents and carriers in the carbonless paper industry. Little was known about the potential impact of these (PCB) substitutes on the basin; therefore (they) were designated an emerging pollutant needing further evaluation.” With the exception of DHEP, the Michigan LaMP goes on to state that “other PCB substitutes (such as DIPN) have not been extensively studied; therefore, information on releases to the environment are limited.” The article further states that information regarding the actual loading of PCB substitutes into Lake Michigan and their impact on the lake ecosystem were unknown (Ref. 5).

An environmental sampling study (Ref. 5), indicated that DIPNs and three other PCB substitutes were identified in effluent from: A de-inking/recycling paper plant and a wastewater treatment facility that received waste water from a carbonless paper manufacturing plant; fish collected near discharge points; and sediments, all of these samples were collected from the Fox River in Wisconsin. However, it is unknown whether all four PCB substitutes were found nor what concentrations were measured in each, and the study lacked environmental fate and transport data for DIPNs. Based on the statements in the LaMP study, EPA concluded that although DIPNs have been detected in a few environmental matrices, it has not been associated with any adverse effects to human health or the environment.

EPA also reviewed the JFSSG Food Surveillance Information Sheet, No. 169, January 1999. The conclusion reached by the JFSSG was that although varying amounts of DIPNs can be carried through the papermaking process to the finished product, there was no correlation between DIPN levels in food and that found in the food packaging materials.

Data was reviewed that demonstrated that 2,6-DIPN does not pose any significant bioaccumulation risk. A summary of metabolism studies/data in support of a temporary tolerance exemption on stored potatoes (PP 8G05008; Ref. 3; MRIDs 451632-01 and 451632-02) was submitted by the registrant, Platte Chemical Co., that demonstrated orally administered DIPNs were rapidly metabolized and excreted by experimental animals, and exhibited little potential for bioaccumulation (Ref. 5). Additionally, experimental animals exposed to DIPNs via inhalation did not exhibit any clinical signs of toxicity or mortality (Ref. 5). Necropsies were negative in experimental animals dosed with DIPNs in all of the aforementioned studies.

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997; FRL-5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of 2,6-DIPN on potatoes at 3 ppm for the peels and 0.5 ppm for potato (whole) ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The classification of 2,6-DIPN as a biopesticide was based on its structural and functional similarity to 1-isopropyl-4,6-dimethylnaphthalene, 1-methyl-7-isopropylnaphthalene, and 4-isopropyl-1,6-dimethylnaphthalene which are naturally occurring plant growth regulators found in plant tissues. In addition, 2,6-DIPN is a sprout inhibitor, with a non-toxic mode of action. Therefore, the toxicity data reviewed include acute oral, dermal and inhalation toxicity studies, eye and skin irritation studies, a dermal sensitization study, subchronic feeding and developmental toxicity studies and genetic toxicity studies.

2,6-DIPN is classified in Toxicity Category IV for mammalian acute oral toxicity (lethal dose (LD)50 > 5,000 mg/kg; OPPTS Harmonized Guideline 870.1100; 152-10; MRID 446141-04), acute dermal toxicity (LD50 > 5,000 mg/kg; OPPTS Harmonized Guideline 870.1200; 152-11; MRID 446141-05), and acute inhalation toxicity (lethal concentration (LC)50 >2.60 mg/L; OPPTS Harmonized Guideline 870.1300; 152-12; MRID 446141-06), eye irritation (OPPTS Harmonized Guideline 870.2400; 152-13; MRID 446141-07) and dermal irritant (OPPTS Harmonized Guideline 870.2500; 152-14; MRID 446141-08). The active ingredient was not allergenic on skin (not a dermal sensitizer; OPPTS Harmonized Guideline 870.2600; 152-15; MRID 446141-09).

The subchronic toxicity study in rats (OPPTS Harmonized Guideline 870.3100; 152-20; MRID 450493-01) suggests a no observed effect level (NOEL) of 104 mg/kg/day (104 or 121 mg/kg/day for males and females, respectively). The lowest observed adverse effect level (LOAEL) is 208 mg/kg/day (208 and 245 mg/kg/day for males and females, respectively), based on minimal decreases in body weight gains, food consumption, adrenal effects (including increased absolute and relative organ weights and adrenal cortical hypertrophy) and kidney toxicity (evidence of tubular nephrosis in male rats).

In the rat developmental toxicity study (OPPTS Harmonized Guideline 870.3700; 152-23; MRID 450001-01), the maternal toxicity LOAEL is 150 mg/kg/day based on reduced body weight gains and food consumption. The maternal toxicity NOAEL is 50 mg/kg/day. The developmental toxicity LOAEL is 500 mg/kg/day based on reduced fetal body weights and a slightly increased incidence of a skeletal alteration (fusion of cartilaginous bands in the cervical centra). The developmental toxicity NOAEL is 150 mg/kg/day.

A mouse lymphoma gene mutation assay (OPPTS Harmonized Guideline 870.5300; 152-17; MRID 454388-01) showed that 2,6-DIPN might be mutagenic without metabolic activation at doses between 10-30 μg/mL. With metabolic activation, the results were equivocal at doses between 25-90 μg/mL. Cytotoxicity was observed in tests using the aforementioned doses, with and without metabolic activation. No genotoxicity was observed in other acceptable studies including a reverse mutation (Ames) assay (OPPTS 870.5100; 152-17; MRID 446141-11), in vivo/in vitro unscheduled DNA synthesis (UDS) assays in rat primary hepatocytes (OPPTS 870.5550; 152-17; MRID 446141-10), and a mouse micronucleus assay (OPPTS 870.5395; 152-17; MRID 446141-12). The collective data from the four-study mutagenicity battery demonstrates that 2,6-DIPN is not likely to be mutagenic.

1. Acute toxicity. The acute toxicity studies were acceptable in accordance with the guidelines as discussed in Unit III.A. All studies were performed at a single limit dose with no observable (non-lethal) toxic endpoints.

2. Short-term and intermediate-term toxicity. Although the rat developmental toxicity study indicates a lower maternal NOEL (50 mg/kg/day) for similar toxicity than the subchronic toxicity study (reduced body weight, weight gain and food consumption), the maternal LOAEL of 150 mg/kg/day falls between the subchronic NOEL of 104-121 mg/kg/day and the subchronic LOAEL of 208-245 mg/kg/day. The maternal NOEL of 50 mg/kg/day from the developmental toxicity study may be appropriate for use in characterization of risks for the subpopulation of women 13-49 years of (child-bearing) age. However, the 104 mg/kg/day NOEL in the subchronic study was selected as the endpoint for short-term and intermediate-term dietary assessments since the effects observed at the subchronic LOAEL (208-245 mg/kg/day) were more thoroughly defined than the developmental effects observed at the LOAEL (500 mg/kg/day) in the developmental toxicity study, which were minimal.

A reference dose (RfD) of 1 mg/kg/day is established by dividing the 104 mg/kg/day NOEL by a 100-fold uncertainty factor (10X for interspecies extrapolation and 10X for intraspecies variability). Available developmental toxicity data on 2,6-DIPN does not indicate extra sensitivity of offspring when compared with that of adult animals, but a developmental toxicity study in a second species and a multigeneration reproduction toxicity study are needed to fully determine age-related differences in response. In addition, residues have been detected in treated potatoes under laboratory and field conditions. Therefore, the default safety factor of 10X is retained, and acute and chronic population adjusted doses (aPAD and cPAD) for dietary risk characterizations are established by dividing the RfD by 10X (accounting for age-related sensitivity for the subpopulations of infants and children). Therefore, the aPAD and cPAD are 0.1 mg/kg/day. ----

3. Chronic toxicity. An extra 10-fold uncertainty factor for the absence of chronic toxicity data were not applied to determine a RfD because 2,6-DIPN has been classified as a biochemical pesticide having a non-toxic mode of action with biological activity more specific to plants than animals. Acute toxicity studies on animals indicated Toxicity Category IV for all routes of exposure. Chronic studies are not required to support registration of biochemical pesticides unless all of the following are true:

i. Has subchronic toxicity.

ii. Its use pattern involves a significant rate, frequency or site of application.

iii. The frequency and level of human exposure are significant (40 CFR 158.690(c)).

4. Carcinogenicity. Based on the 90-day oral toxicity study and the genotoxicity/mutagencity studies, there were no results to indicate potential neoplastic changes, and the genetic toxicity studies did not suggest carcinogenic potential in mammalian cells.

1. Dietary exposure from food and feed uses. There is a potential for dietary exposure to 2,6-DIPN, which can occur following its application to stored potatoes. According to the label, the plant growth regulator is to be applied at a rate of 16.6 ppm (weight/weight), and as many as three applications can be used in a storage period with a minimum interval between application and use of the treated potatoes of 30 days.

Residue profile. The submitted residue chemistry data for the use of 2,6-DIPN on potatoes is limited, and important factors in this assessment depend on default assumptions or hypothetical calculations having a low level of confidence.

For purposes of this rule, the regulated residue is considered to be 2,6-DIPN, and a potential for some accumulation of 2,6-DIPN residues in body and subcutaneous fat was observed. These results and the possible use of peels with residues from treated potatoes as livestock feed (processed potato wastes are used for this purpose) suggest that residues of 2,6-DIPN may occur in meat and milk; however, this has not been evaluated in a livestock metabolism study.

Limited field and laboratory residue data suggested tolerance levels as high as 0.5 ppm in/on whole potatoes, 3 ppm on potato peels, 1.35 ppm in meat and meat by-products, and 0.7 ppm in milk.

The analytical method for 2,6-DIPN has a level of quantification (LOQ) of 0.02 ppm and field and laboratory studies suggests that 20 ppm is a likely maximum commercial application rate for 2,6-DIPN. Residue levels expressed as 2,6-DIPN were reported at 3 ppm in potato peels and 0.5 ppm in whole potatoes.

In a published report (MRID 451632-01), the investigators noted that DIPNs could accumulate in the fat of treated rats suggesting a potential for secondary residues in meat and milk from livestock fed treated potatoes, but a livestock metabolism study was not submitted. Worst-case estimates of secondary residues were calculated for meat (1.35 ppm) and milk (0.7 ppm) of beef/dairy cattle fed waste from 2,6-DIPN-treated processed potatoes.

Supplementary metabolism information was submitted on 2,6-DIPN in rats from two published articles (MRID 451632-01). In one study, rats were given either a single dose or 30 daily oral doses, at 100 mg 2,6-DIPN per kg body weight. Residues of 2,6-DIPN were detected in all tissues 2 hours after receiving the test dose. With the exception of body and subcutaneous fat, DIPN was not detected 48 hours after the single (100 mg/kg) dose. Peak levels in body and subcutaneous fat were found 24 hours after dosing at 75 and 85 μg/g of tissue, respectively; these levels declined to approximately 60 μg/g by 48 hours following the single dose. Results were similar in rats given the repeated doses with the peak levels in body and subcutaneous fat reported to be 150 and 90 μg/g, respectively, at 2 hours following administration of the last dose. By 30 days after this last dose was given, the 2,6-DIPN levels in fat had declined to 5 μg/g. The estimated half-life for 2,6-DIPN in fat was approximately 7 days, and the investigators noted that DIPNs had a small potential for accumulation in fat (levels increased from 2 to 7% over those found after a single dose in subcutaneous and body fat, respectively). Worst-case estimates of secondary residues were calculated for meat (1.35 ppm) and milk (0.7 ppm) of beef/dairy cattle fed waste from 2,6-DIPN-treated processed potatoes. These tolerance provide a reasonable certainty of no harm and livestock feeding studies will allow further refinement of these estimates.

In the second article, it was noted that 2,6-DIPN was metabolized in rats primarily by way of an oxidative pathway involving the isopropyl groups. Five metabolites were identified in urine from rats given an oral dose of 240 mg 2,6-DIPN per kg body weight, and the majority of the DIPN residues recovered in the urine (23% of the dose at 24 hours) was represented by 2-[6(1-hydroxy-1-methyl)ethylnaphthalen-2-yl]-2-hydroxypionic acid (17.5% of the dose). This study did not explain the fate of the remaining 77% of the administered dose. The livestock feeding study should determine the fate of the administered dose, but because worst-case estimates were used to establish the tolerances, there is a reasonable certainty of no harm.

Acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software (DEEMTM version 1.30) which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals (CSFII, 1994-1996/1998).

For acute exposure assessments, individual 1-day food consumption data define an exposure distribution which is expressed as a percentage of the aPAD (aPAD is 0.1 mg/kg). For chronic exposure and risk assessment, an estimate of the residue level in each food or food-form on the commodity residue list is multiplied by the average daily consumption estimate for the food/food-form. The resulting residue consumption estimate for each food/food-form is summed with the residue consumption estimate for all other food/food-forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates are expressed as mg/kg body weight/day and as a percent of the cPAD (0.1 mg/kg/day). It is just as likely that the exposure estimates are appropriate, given that it is not uncommon for the peels to be eaten. These procedures were performed for each population subgroup.

As a condition of registration, the registrant will be required to submit livestock feeding studies and enforcement analytical methods for livestock and potatoes; however, EPA believes that its analyses, which rely on the available data, supplemented with conservative assumptions, are sufficient to support a tolerance for the short period during which these studies are conducted.

2. Dietary exposure from drinking water. Pesticide residues in drinking water are not expected to result from this use. The use is restricted to application in a commercial warehouse to stored potatoes. In addition, the label will restrict users from contaminating water supplies when cleaning equipment or disposing of equipment wash waters.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

2,6-DIPN is not registered for use on any sites that would result in residential exposure, but is restricted to use in commercial warehouses.

4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether 2,6-DIPN has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, 2,6-DIPN does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2,6-DIPN has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional ten-fold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. The toxicity data on 2,6-DIPN does not indicate extra sensitivity of offspring when compared with that of adult animals, but the data base does not represent a complete assessment of potential age-related sensitivity or acute effects other than lethality. The following data would be necessary to allow for a complete assessment: A developmental toxicity study in a second species, a multigeneration reproduction toxicity study, or a range of doses adequate to induce a full range of toxic responses, especially potential acute effects in any of the available studies.

3. Conclusion. In light of the absence of a developmental toxicity study in a second species, a multigeneration reproduction toxicity study, or a range of doses adequate to induce a full range of toxic responses, especially potential acute effects in any of the available studies, EPA has retained the default 10-fold safety factor

1. Acute risk. Acute dietary exposure estimates were based on the available residue data and worst-case assumptions (Refs. 1 and 2). For the U.S. population, acute dietary exposure was estimated to be 0.023113 mg/kg. These values represented 23.11% of the aPAD. The subpopulation with the highest acute dietary exposure estimate was children 1 to 6 years of age (0.053492 mg/kg; 53.49% of the aPAD). The acute dietary exposures to all the subpopulations in the analysis did not exceed EPA's level of concern (> 100% of the aPAD).

2. Chronic risk. Using the exposure assumptions described previously for chronic exposure, EPA has concluded that the chronic dietary exposure for the general population was estimated to be 0.006939 mg/kg/day, 6.9% of the cPAD. The subpopulation with the highest chronic dietary exposure estimate was children 1 to 6 years of age, with estimated exposures of 0.023247 mg/kg/day, which constitutes 23.25% of the cPAD.

3. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to 2,6-DIPN residues. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

A liquid chromatography (HPLC) method was used to measure the levels of 2,6-DIPN in the residue study.

Adequate enforcement methodology (for example, gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

There are no Codex Alimentarius Commission (Codex) maximum residue levels for residues of 2,6-DIPN.

Based upon the risk assessment, residue data and use pattern described above, a temporary tolerance is established for residues of 2,6-DIPN in raw potatoes and potato peel at 0.5 ppm and 3 ppm respectively.

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, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA 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) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 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 ID number OPP-2003-0127, 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 October 7, 2003.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

2. Tolerance 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 20460-0001.

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 20460-0001.

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.1. Mail your copies, identified by docket ID number OPP-2003-0127, 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 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. 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).

1. EPA Memorandum. Roger Gardner to Manying Xue. “Addendum to a previous review of a petition for an exemption from the requirement of a tolerance (PP# 1F06338) for 2,6-DIPN (PC 055803) in/on stored potatoes (EPA File Symbol No. 34704-IUE; DP Barcodes D276743 and D276753; Submission Nos. S601233 and S601234).” March 7, 2003.

2. EPA Memorandum. Roger Gardner to Driss Benmhend. “Petition for an exemption from the requirement of a tolerance (PP# 1F06338) for 2,6-DIPN (PC 055803) in/on stored potatoes (EPA File Symbol No. 34704-IUE; DP Barcodes D276743 and D276753; Submission Nos. S601233 and S601234).” December 10, 2002.

3. EPA Memorandum. Russell S. Jones to Driss Benmhend. “Renewal Request for an Experimental Use Permit for Amplify® Sprout Inhibitor (EPA Symbol No. 034704-EUP-13), containing 99.7% 2,6-Diisopropyl-napthlalene [2,6-DIPN; (Chemical No. 055803)] as its Active Ingredient; and a Petition to Extend the Temporary Exemption from the Requirement of a Tolerance on Stored Potatoes (PP# 8G05008). Review of Toxicity, Metabolism, and Residue Chemistry Studies. DP Barcodes D267369 and D267587; Case Nos. 062532 and 290334; Submission Nos. S581969 and S582755; MRIDs 451632-01 and -02.” August 3, 2000.

4. EPA Memorandum. Russell S. Jones to Driss Benmhend. “Amplify® Sprout Inhibitor (EPA Symbol No. 034704-EUP-13), containing 99.7% 2,6-Diisopropyl-napthlalene [2,6-DIPN; (Chemical No. 055803)] A New Active Ingredient; and a Petition For Exemption from the Requirement of Tolerances for 2,6-DIPN on Food Commodities (PP# 1F06338). Response to Comments Received Following Publication of an FR Notice Regarding a Request for a Tolerance Exemption for 2,6-DIPN. DP Barcode D278840; Case No. 070700; Submission No. S601234; No MRID Nos.” August 7, 2000.

5. Lake Michigan Lakewide Management Plan (LaMP Study). United States Environmental Protection Agency, Office of Water, Chapter 5 pp 5-125. April 2000.

This final rule establishes a temporary tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the temporary tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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).

This is a summary of the Commission's Order in CC Docket No. 96-45 released on July 24, 2003. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 Twelfth Street, SW., Washington, DC 20554.

1. In this Order, we adopt measures to ensure that our implementation of the Children's Internet Protection Act (CIPA) complies with the recent decision of the United States Supreme Court. CIPA requires schools and libraries with “computer Internet access” to certify that they have Internet safety policies and technology protection measures, e.g., software filtering technology, to receive discounts for Internet access and internal connections under the schools' and libraries' universal service support mechanism (e-rate).

2. Libraries subject to CIPA's filtering requirements that are not currently in compliance with the CIPA filtering requirements must undertake efforts in Funding Year 2003 to comply by Funding Year 2004 in order to receive e-rate funds. Libraries must be in compliance with the CIPA requirements by Funding Year 2004, except to the extent such libraries are eligible for and receive a waiver of the CIPA requirements pursuant to section 254(h)(6)(E)(ii)(III). We direct the Administrator in consultation with the Wireline Competition Bureau (Bureau) to implement the necessary procedural changes, including changes to the current CIPA-related certifications required of applicants. We take these steps to respond promptly to the Supreme Court's decision and to ensure that the schools' and libraries' universal service support mechanism continues to operate in accordance with federal law.

3. Consistent with the Supreme Court decision, as of the effective date of this Order, we lift the suspension of enforcement of those § of 54.520 of our rules which implemented the section 254(h)(6) requirement that libraries have Internet filtering technology to receive discounts for Internet access and internal connections under e-rate. Specifically, we lift the suspension of enforcement of §§ 54.520(c)(2)(i) and (iii), 54.520(c)(3), 54.520(d), and 54.520(g)(1) of our rules as applied to libraries. In addition, we modify § 54.520(f) and (g) to conform with the revised timeline for the implementation of section 254(h)(6) of the Act.

4. Consistent with the implementation framework established by Congress, libraries receiving e-rate discounts for Internet access or internal connections shall have one year from July 1, 2003, which is the start of Funding Year 2003, to come into compliance with the filtering requirements of CIPA. When Congress enacted CIPA in 2001, it recognized that it may take libraries a significant amount of time to procure and install the Internet filtering technology required to comply with CIPA. Accordingly, CIPA allows libraries either to certify (1) that they are in compliance with CIPA or (2) that they are “undertaking such actions, including any necessary procurement procedures, to put in place” the required policy measures to comply with CIPA for the next funding year. Given that the Supreme Court decision was issued on June 23, 2003 and will be effective no sooner than July 18, 2003, we believe that it is unrealistic to expect all libraries to be in a position to certify compliance with CIPA for Funding Year 2003, which began July 1, 2003. In order to comply with the statute's Internet filtering requirement, many libraries must prepare a budget for the purchase of software and related costs, design, procure and/or order software appropriate for their systems, install the software and implement a procedure for unblocking the filter upon request by an adult. This process, as Congress recognized, would almost certainly take some time to complete. Therefore, we conclude that allowing libraries this time period to comply with CIPA filtering requirements is consistent with Congress's intent in enacting CIPA and with the public interest.

5. During Funding Year 2003, all libraries that receive discounts for Internet access or internal connections must certify that they are either compliant with CIPA or undertaking efforts to be in compliance by the time the libraries commence services for Funding Year 2004. Libraries that are not in compliance with CIPA for Funding Year 2003 and will not be undertaking efforts during Funding Year 2003 to comply with CIPA by Funding Year 2004 may not receive e-rate funds for Internet access or internal connections for Funding Year 2003. Such libraries may receive e-rate funds only for telecommunications services. All libraries that have not filed an FCC Form 486 prior to the effective date of this Order must file the revised FCC Form 486. All libraries that filed the September 2002 version of the FCC Form 486 prior to the effective date of this Order and will receive discounts for Internet access or internal connections for Funding Year 2003 must also refile using the revised FCC Form 486. The deadline for submitting all revised FCC Form 486s remains the same for all libraries—the later of 120 days after the Service Start Date or 120 days after the date of the Funding Commitment Decision Letter. Libraries that filed the September 2002 version of the FCC Form 486 for Funding Year 2003 prior to the effective date of this Order and that receive e-rate funds only for telecommunications services are not required to file a revised FCC Form 486. The filing of a revised FCC Form 486 for such libraries is unnecessary because they do not need to certify compliance with the CIPA filtering requirements.

6. These filing requirements also apply to library consortium leaders. Billed entities that are library consortium leaders should abide by the instructions for filing the FCC Form 486. Billed entities that previously filed the September 2002 version of FCC Form 486 on behalf of library consortium members must file the revised FCC Form 486, unless all members of the consortium receive e-rate funds only for telecommunications services. In addition, all library consortium members must file with their billed entity, and all billed entities must collect and hold from each consortium member the revised FCC Form 479. All library consortium members that filed an FCC Form 479 prior to the effective date of this Order must file a revised FCC Form 479 with their billed entity within 45 days after the effective date of this Order. In order for such library consortium members to receive e-rate funds for Internet access and internal connections for Funding Year 2003, they must be in compliance with CIPA or undertaking efforts to be in compliance with CIPA at the time the revised FCC Form 479 is filed. Library consortium members that did not file FCC Form 479 prior to the effective date of this Order should work with their billed entity to determine when to submit the revised FCC Form 479. In addition, billed entities whose consortia include both libraries that are in compliance with CIPA for Funding Year 2003 or undertaking efforts to comply for Funding Year 2004 and libraries that do not intend to comply with CIPA must file FCC Form 500 to adjust their funding commitments as applicable within 30 days after filing the revised FCC Form 486. This FCC Form 500 filing requirement is necessary only for Funding Year 2003 because of the timing of the Supreme Court decision.

7. CIPA also provides for a waiver of the certification requirements in the second year after the effective date of CIPA if state or local procurement rules or regulations or competitive bidding requirements prevent compliance. Accordingly, consistent with this provision of CIPA, a library or billed entity that applies for discounts in Funding Year 2003 may submit a waiver request for Funding Year 2004 if state or local procurement rules or regulations or competitive bidding requirements prevent compliance by the start of Funding Year 2004. The revised FCC Forms 486 and 479 attached to this Order have been revised to reflect this option.

8. Pursuant to the authority of sections 1-5 and 254 of the Communications Act of 1934, as amended, 47 U.S.C. 151-155, and 254, and the Children's Internet Protection Act, Public Law 106-554 section 1701 et seq. as codified at 47 U.S.C. 254(h) and (l), this Order is adopted. The modifications to a collection of information contained within this Order are contingent upon approval by the Office of Management and Budget.

9. The suspension of enforcement implemented in the Interim Order, 67 FR 50602, August 5, 2002, of §§ 54.520(c)(2)(i) and (iii), 54.520(c)(3), 54.520(d), and 54.520(g)(1) of the Commission's rules as they apply to all libraries and to the extent that they require any library to filter or certify to such filtering under 47 U.S.C. 254(h)(6), is lifted as of the effective date of this Order, consistent with the terms of this Order.

10. Pursuant to the authority contained in sections 1-4, 201-205, 218-220, 254, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 201-205, 318-220, 254, 303(r), 403, section 553 of the Administrative Procedure Act, 5 U.S.C. 553, and the Children's Internet Protection Act, Public Law 106-554 section 1701 et seq. as codified at 47 U.S.C. 254(h), the amendments to §§ 54.520 (f) and (g) of the Commission's rules are adopted.

11. Authority is delegated to the Chief of the Wireline Competition Bureau pursuant to section 5(c) of the Communications Act of 1934, 47 U.S.C. 155(c), to modify any forms that are necessary to implement the decisions adopted in this Order.

12. The rule and the revised FCC Forms 479 and 486 in this document contain collection requirements that have not been approved by OMB. Upon OMB approval, the Commission will publish a document in the Federal Register announcing the effective date of the rule and the revised FCC Forms 479 and 486.

This is a synopsis of the Commission's Memorandum Opinion and Order in MM Docket No. 00-18, adopted July 24, 2003, and released July 25, 2003. The full text of this decision is available for inspection and copying during normal business hours in the FCC 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 copy contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone (202) 863-2893, facsimile (202) 863-2898, or via e-mail qualixint@aol.com.

This is a summary of the Commission's Report and Order, MB Docket No. 03-105, adopted July 23, 2003, and released July 24, 2003. The full text of this Commission decision is available for inspection and copying during regular business hours in the FCC's Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 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.

This is a synopsis of the Commission's Report and Order, MB Docket No. 03-13, adopted July 23, 2003, and released July 24, 2003. The full text of this Commission 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. This document may also be purchased from the Commission's duplicating contractors, Qualex International, Portals II, 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.

This is a synopsis of the Commission's Report and Order in MM Docket No. 03-116, adopted July 30, 2003, and released August 1, 2003. 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 copy 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 Commission makes recommendations regarding management of the Pacific halibut fishery under the Convention between the United States and Canada. The Commission's recommendations are subject to approval by the Secretary of State with concurrence of the Secretary of Commerce (Secretary). Additional management regulations that are not in conflict with regulations adopted by the Commission, may be developed by the North Pacific Fishery Management Council (Council) to allocate harvesting privileges among U.S. fishermen.

The Halibut Act provides NMFS, in consultation with the Council, with authority to implement such allocation measures through regulatory amendments approved by the Secretary. In addition to the Commission regulations, the commercial halibut fishery off Alaska is managed under the halibut Individual Fishing Quota (IFQ) Program implemented in 1995.

Each year the Commission staff assesses the abundance and potential yield of Pacific halibut using all available data from the commercial fishery and scientific surveys. Harvest limits for ten regulatory areas are determined by fitting a detailed population model to the abundance and harvest data from each area. A biological target level for total removals in a given area is then calculated by multiplying a fixed harvest rate presently 20 percent to the estimate of exploitable biomass. This target level is called the “constant exploitation yield” (CEY) for that area in the coming year. Each CEY represents the target level for total removals (in net pounds) for that area. The Commission then estimates the sport and personal use, subsistence harvests, wastage, and bycatch mortalities for each area. These are subtracted from the CEY and the remaining amount of fish may be set as the catch quota or “setline CEY” for each area's directed commercial fixed gear fishery. The setline CEY is a fixed quota, but other removals of fish are not allocated a specific quota.

Harvests by the guided recreational fishery and other non-commercial harvests are thus unrestricted within the CEY because no specific amount is allocated to the guided fishery. This represents an open-ended allocation to the guided recreational fishery from quota available to the commercial halibut fishery. Hence, as the guided recreational fishery expands, its harvests reduce the pounds available to be fished in the commercial halibut fishery and, subsequently, the value of quota shares (QS) in the IFQ Program.

The Council recognized the growth of harvests in the guided recreational fishery and adopted a problem statement in 1995 that recognized that ever increasing harvests in this fishery may make achievement of Magnuson-Stevens Act National Standards more difficult. Of concern was the Council's ability to maintain the stability, economic viability, and diversity of the halibut industry, the quality of the recreational experience, the access of subsistence users, and the socioeconomic well-being of the coastal communities dependent on the halibut resource. This policy statement led to the development of a GHL policy that would address allocative concerns in the Council's problem statement. More detail on the development of the GHL policy is provided in the preamble to the proposed rule, published in the Federal Register on January 28, 2002 (67 FR 3867).

This final rule establishes a GHL policy which specifies a level of harvest for the guided recreational fishery. If the GHL is exceeded, then NMFS will notify the Council within 30 days of receiving information that the GHL has been exceeded. At that time the Council may initiate analysis of possible harvest restrictions and NMFS may initiate subsequent rulemaking to reduce guided recreational harvests. This final rule does not establish specific harvest restrictions for the guided recreational fishery. This final rule does not prevent the Council from recommending management measures before the guided recreational fishery exceeds a GHL, nor does it obligate the Council to take specific action if the GHL is exceeded. Under this GHL policy, NMFS would notify the Council if a GHL for the guided recreational harvests has been met or exceeded.

This final rule is the result of ongoing efforts by the Council to address allocation concerns between the commercial IFQ halibut fishery and the guided recreational fishery. The Council has discussed the expansion of the guided recreational halibut fishery since 1993. In September 1997, the Council adopted two management actions affecting the halibut guided recreational fishery, culminating more than 4 years of discussion, debate, public testimony, and analysis.

First, the Council adopted recording and reporting requirements for the halibut guided recreational fishery. To implement this requirement, the Alaska Department of Fish and Game (ADF&G) Sport Fish Division, instituted a Saltwater Charter Vessel logbook (Logbook) in 1998. It complemented additional sportfish data collected by the State of Alaska (State) through the Statewide Harvest Survey (Harvest Survey), conducted annually since 1977, and the on-site (creel and catch sampling) surveys conducted separately by ADF&G in Southeast and Southcentral Alaska.

The Council's second management action recommended GHLs for the guided recreational halibut fishery in Commission regulatory areas 2C and 3A. The GHLs were based on the guided recreational sector receiving an allocation of 125 percent of its 1995 harvest. This amount was equivalent to 12.76 percent and 15.61 percent of the combined commercial/guided recreational halibut quota in areas 2C and 3A, respectively.

The Council stated its intent that guided recreational harvests in excess of the GHL would not lead to a mid-season closure of the fishery, but instead would trigger other management measures to take effect in years following attainment of the GHL. These measures would restrict the guided recreational fishery and maintain harvests within the GHL allocation. The overall intent was to maintain a stable guided recreational season of historic length, using area-specific harvest restrictions. If end-of-season harvest data indicated that the guided recreational sector likely would reach or exceed its area-specific GHL in the following season, NMFS would implement measures to reduce guided recreational halibut harvest.

Given the one-year lag between the end of the fishing season and availability of that year's harvest data, management measures in response to the guided recreational fleet's meeting or exceeding the GHL would take up to two years to become effective. However, the Council did not recommend specific management measures to be implemented by NMFS if the GHL were reached.

In December 1997, the NMFS Alaska Regional Administrator informed the Council that publishing the GHL as a regulation without specific management measures would have no regulatory effect on the guided recreational fleet. Further, because the Council had not recommended specific management measures by which to limit harvests if the GHL were reached, no formal approval decision by the Secretary would be required for the Council's proposed GHL policy. Hence, a GHL proposed rule would not be developed and forwarded for review by the Secretary.

After being notified that its 1997 GHL policy recommendation would not be submitted for Secretarial review, the Council initiated a public process to develop potential harvest restrictions to implement if the GHL were exceeded. The Council formed a GHL Committee to recommend alternative management measures for analysis that would constrain guided recreational harvests below the GHL. In April 1999, the Council identified alternatives for analysis.

In February 2000, after 7 years of discussing the guided recreational halibut fishery, the Council adopted a redefined guided recreational GHL and a system of management measures for recommendation to the Secretary. The Council's recommendation would have established a suite of varying harvest restrictions that would be triggered depending on the degree to which the GHL was exceeded. Once the GHL is reached or exceeded, these measures would be implemented by notice published in the Federal Register. Essentially, the Council's recommendation included a “framework” of restrictions that were explicitly designed to be implemented without proceeding through public notice and comment before becoming effective.

NMFS sent a letter to the Council on April 2, 2002, informing the Council that “[t]he current framework cannot be implemented as conceived by the Council because the Administrative Procedure Act (APA) requires that any regulatory action have prior notice and opportunity for public comment before becoming effective.”

The notification process described in the proposed rule contemplated compliance with the APA in establishing the framework of harvest restrictions that would be scaled to match the extent to which the guided recreational fishery exceeded the GHL. This framework of potential restrictions, which would be automatically triggered depending on how much the GHL is exceeded, was designed by the Council to minimize the time between exceeding a GHL and the implementation of one or more restrictions. Public comment was specifically invited on the range of restrictions and the link between this range and the level that the guided recreational fishery exceeded the GHL.

This process of implementing pre-conceived and non-discretionary restrictions by notice, depending on how much the GHL is exceeded, however, would not have provided for additional public comment at the time of implementing a restriction. The NMFS letter to the Council indicated that this lack of additional public comment would not be consistent with the APA.

The public comment required by the APA can be waived only for “good cause.” The harvest restrictions in the proposed rule likely could not be implemented under the “good cause” exemption of the APA. The APA provides for a “good cause” finding only when the agency finds that notice and opportunity for public comment would be impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(B)). These terms are narrowly defined. Because this “good cause” finding would need to be made at the time the harvest restrictions are implemented, NMFS could not conclude in advance that a “good cause” finding would exist in every instance the GHL was exceeded and harvest restrictions triggered. This requirement would effectively undermine the goal of the framework measures to expedite implementation of harvest restriction measures on the guided recreational fishery.

NMFS presented this letter to the Council at its April 2002 meeting, but no action was taken. NMFS sent a second letter to the Council on September 6, 2002, which further clarified factors that may affect the approval of the GHL program and suggested alternative ways to meet the Council's intent.

The September 6, 2002, letter noted that the proposed rule could be approved only if it were changed to explicitly provide for an opportunity for public comment before implementing any harvest restrictions. This change would increase the amount of time between when the GHL is exceeded and implementing any harvest restrictions, because the APA rulemaking process would require an analysis of alternatives to the proposed harvest restrictions recommended by the Council under the requirements of the Regulatory Flexibility Act, the National Environmental Policy Act, Executive Order (E.O.) 12866 (which requires a Regulatory Impact Review), and other applicable laws.

The Council discussed this letter in October 2002. The Council indicated that its preferred course of action would be to implement the GHL policy as a rule and to develop possible harvest restriction measures as necessary at a later time through a separate analytical and rulemaking process. Under this scenario, the Council would undertake its usual process of forwarding recommendations to NMFS based on analysis of alternatives each time recreational guided harvests exceed the GHL.

On December 2, 2002, NMFS informed the Council by letter that NMFS intended to proceed as recommended by the Council in October, with a final rule to implement the GHL policy without the associated harvest restriction measures. NMFS presented this letter to the Council at its December 2002 meeting. This letter noted that if the GHL were exceeded, subsequent harvest restrictions could be implemented as needed under normal APA rulemaking with the accompanying analyses (e.g., EA/RIR/IRFA). In other words, this final rule would establish the GHL policy and require NMFS to notify the Council when a GHL is exceeded, which could serve as a trigger for subsequent rulemaking.

Hence, this final rule deviates from the proposed rule (January 28, 2002, 67 FR 3867) by omitting all of the proposed restrictions. The specific changes in this final rule from the proposed rule are described in the Changes from the Proposed Rule section of this final rule.

The GHL establishes a pre-season estimate of acceptable annual harvests for the guided recreational halibut fishery in Commission areas 2C and 3A. To accommodate limited growth of the guided recreational fleet while approximating historical harvest levels, the GHL for each area is based on 125 percent of the average of 1995-99 guided recreational harvest estimates as reported by the ADF&G's Harvest Survey. The average harvest during the 1995-1999 time period was chosen as being representative of recent trends in guided fishery harvests with the additional 25 percent over this average added to accommodate limited future growth based on estimated guided fishery harvest trends. The GHLs equal 1,432,000 lb (649.5 mt) net weight in area 2C, and 3,650,000 lb (1,655.6 mt) net weight in area 3A. These amounts equate to 13.05 percent, and 14.11 percent, respectively, of the combined guided recreational and commercial allowable harvest.

The GHLs are established as a total maximum poundage, which is responsive to annual reductions in stock abundance. In the event of a reduction in either area's halibut stocks, as determined by the Commission, the area GHL is reduced incrementally in a stepwise fashion in proportion to the stock reduction. The GHL is reduced by fixed percentages if the stock abundance falls below the average 1999-2000 stock abundance. The 1999-2000 time frame was chosen because these were the two years most recent to the Council's action.

The final rule implementing measures contained in Framework 38 to the FMP was published in the Federal Register on July 9, 2003 (68 FR 40810), and became effective on the date of publication. The North Latitude coordinate for Point GRF5 (44° 58.5′) in the table, GOM Grate Raised Footrope Trawl Whiting Fishery Exemption Area, contained in § 648.80(a)(16), was incorrect in the final rule document. A final rule; correcting amendment was published in the Federal Register on July 25, 2003 (68 FR 43974). That document corrected the North Latitude coordinate for Point GRF5, which is 43° 58.8′. However, in the correction document published July 25, 2003, the headings contained in the table in § 648.80(a)(16) were incorrect.

Therefore, because the final rule published on July 25, 2003, which was the subject of FR Doc. 03-18894, contained incorrect table headings in § 648.80(a)(16), on page 43974, in the first column of the table the column heading “Point N.” is removed and in its place “Point” is added. In the second column of the table the column heading “Lat.W.” is removed and in its place “N. Lat.” is added. In the third column the heading “Long.” is removed and in its place “W. Long.” is added.

This document corrects the table under § 648.80(a)(16) as follows:

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Gulf of Alaska (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 50 CFR part 679.

The allocation of the “other rockfish” TAC in the Central Regulatory Area was established as 550 metric tons by the final 2003 harvest specifications for groundfish in the GOA (68 FR 9924, March 3, 2003).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS, has determined that the allocation of the “other rockfish” TAC in the Central Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that further catches of “other rockfish” in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the prohibition of retention, lead to exceeding the TAC of “other rockfish” in the Central Regulatory Area of the GOA, and therefore reduce the public's ability to use and enjoy the fishery resource.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Gulf of Alaska (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 50 CFR part 679.

The allocation of the shortraker/rougheye rockfish TAC in the Central Regulatory Area was established as 840 metric tons by the final 2003 harvest specifications for groundfish in the GOA (68 FR 9924, March 3, 2003).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS, has determined that the allocation of the shortraker/rougheye rockfish TAC in the Central Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that further catches of shortraker/rougheye rockfish in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the prohibition of retention, lead to exceeding the TAC of shortraker/rougheye rockfish in the Central Regulatory Area of the GOA, and therefore reduce the public's ability to use and enjoy the fishery resource.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.