Over thirty years ago, Congress established a policy of openness toward public disclosure of government information by enacting the Freedom of Information Act (FOIA) (5 U.S.C. 522). Under FOIA, any member of the public may request access to information within control of a federal executive branch agency. GAO is a legislative agency and is, therefore, not subject to the FOIA. Nevertheless, GAO has voluntarily adopted an information disclosure policy that includes many of the procedural principles contained in FOIA. GAO also is not subject to the Electronic Freedom of Information Act Amendments of 1996 (E-FOIA), Public Law 104-231, which amended FOIA to provide greater public access to information maintained in an electronic format. This final rule amends GAO regulations addressing the public availability of GAO records by adopting practices similar to E-FOIA procedures.

GAO adopts only certain procedural features of the FOIA and E-FOIA, as opposed to adopting substantive law. Application of the FOIA and the E-FOIA to the GAO is not to be inferred (4 CFR 81.1). This rule is published as a final rule without notice or an opportunity for comment. The Administrative Procedures Act (APA), 5 U.S.C. 551 et seq. , does not apply to GAO. GAO voluntarily follows key principles set forth in the APA, like it voluntarily follows many of the procedural principles set forth in FOIA. Since this rule is procedural in nature, rather than substantive, it is consistent with the principles of the APA for GAO to issue it as a final rule without providing notice and an opportunity for public comment. This has been GAO's past practice as GAO has amended part 81 on previous occasions without soliciting public comment. (See for example 53 FR 50913 (Dec. 19, 1988), 49 FR 38527 (Oct. 1, 1984), and 46 FR 47053 (Sept. 24, 1981).)

Other changes to GAO's records disclosure regulations are made to reflect current GAO policy, practices, and procedures, including but not limited to organizational changes, which resulted in new titles, addresses, telephone numbers, and hours of operation that relate to GAO processing requests for GAO records and documents.

In accordance with the spirit of E-FOIA, a new provision is added to section 81.1 informing the public that GAO publications (testimonies, reports, decisions, and listings of publications) are now expressly included within the scope of the regulations to the extent that the public may readily obtain copies of them from the GAO Web site, http://www.gao.gov or from the U.S. General Accounting Office, 441 G Street NW., Room LM, Washington, DC 20548. The address for writing and the telephone numbers for calling GAO to obtain copies of GAO published documents are moved from section 81.2 to section 81.1 for consistency to have all pertinent information for obtaining published documents provided in the same section.

Section 81.2 is updated by correcting the title of the GAO official who has the authority and responsibility for administering the GAO records disclosure program, including issuing necessary supplemental rules and regulations. Paragraph (b) of section 81.3 revises the definition of the term “records” to expressly include electronically created or maintained materials. The language is amended to state in plain language that only existing records and records under GAO control are covered.

Recognizing that some requests may have more urgency than others, paragraph (f) is added to § 81.3 to provide a definition of “compelling need” for purposes of determining whether to honor requests for expedited processing. Section 81.4 revisions provide requesters with the correct name and address for sending to GAO requests for documents that have not been published. The GAO Internet home page address is also provided so requesters may submit their requests electronically.

Under § 81.4 as it is amended, GAO will respond to a requester by acknowledging or honoring the request within 20 days of receipt. In light of this procedure, the requirement that GAO promptly honor requests when no valid objection exists for withholding the records is no longer necessary and is therefore eliminated. Expedited requests where a requester provides GAO with a certified statement demonstrating a compelling need will be processed before other requests. A 60-day time limit for requesting an administrative appeal of a denial of a request is established. Section 81.5, concerning records originating outside GAO and records involving work in progress, is not changed.

Revisions to section 81.6 clarify and set out in greater detail current GAO policy and practice regarding records exempt from disclosure. In this regard, paragraph (l) is divided into two paragraphs, (l) and (m). Other revisions to section 81.6 reflect changes to organizational structure by correcting the title of the GAO official with discretion to release exempt records from the Director of Policy to the Chief Quality Officer. The GAO fee schedule set out in section 81.7 is updated to reflect current costs associated with processing requests. Other revisions inform requesters of the recent change in the title of the official responsible for deciding whether a fee should be waived or reduced. Changes to section 81.8 delineate that the GAO's public reading facility is maintained in the GAO Law Library, and its location and hours of operation. The hours of operation for public use of the Law Library are changed to 8:30 a.m. to 4 p.m. GAO's public reading facility was previously open to the public from 8:30 a.m. to 5 p.m. It continues to be closed on Saturdays, Sundays, and holidays.

The FAA has determined that notice and opportunity for public comment in accordance with 14 CFR 11.38 are unnecessary, because the FAA has provided previous opportunities to comment on substantially identical special conditions and has fully considered and addressed all the substantive comments received. Based on a review of the comment history and the comment resolution, the FAA is satisfied that new comments are unlikely. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

However, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m., and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we received.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On September 23, 2002, Raytheon Aircraft Services, Inc., 1115 Paul Wilkins Road, San Antonio, Texas 78216, applied for a supplemental type certificate (STC) to modify Raytheon Model HS.125 Series 700A and 700B airplanes. These models are currently approved under Type Certificate No. A3EU. The HS.125 Series 700A and 700B airplanes are two flightcrew, two-engine airplanes, each with a maximum takeoff weight of 25,500 lbs. The modification incorporates the installation of a Rockwell Collins AFD 2000 EFIS. This equipment will replace the equipment originally installed in these airplanes which presents the required flight information in the form of analog displays. The avionics/electronics and electrical system to be installed has the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, Amendment 21-69, effective September 16, 1991, Raytheon Aircraft Services, Inc. must show that the modified Model HS.125 Series 700A and 700B airplanes, as modified, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A3EU, or the applicable regulations in effect on the date of application for the change. Subsequent changes have been made to § 21.101 as part of Amendment 21-77, but those changes do not become effective until June 10, 2003. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.”

If the Administrator finds that the applicable airworthiness regulations ( i.e. , part 25, as amended) do not contain adequate or appropriate safety standards for the Model HS.125 Series 700A and 700B airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Raytheon Model HS.125 Series 700A and 700B airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 and become part of the type certification basis in accordance with § 21.101(b)(2), Amendment 21-69, effective September 16, 1991.

Special conditions are initially applicable to the model for which they are issued. Should Raytheon Aircraft Services, Inc. apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate A3EU to incorporate the same or similar novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

As noted earlier, the Raytheon Model HS.125 Series 700A and 700B airplanes modified by Raytheon Aircraft Services, Inc. will incorporate an EFIS that will perform critical functions. This system may be vulnerable to high-intensity radiated fields external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, this system is considered to be a novel or unusual design feature.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Raytheon Model HS.125 Series 700A and 700B airplanes modified by Raytheon Aircraft Services, Inc. These special conditions require that new avionic/electronic and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters and the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical digital avionic/electronic and electrical systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1 or 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths indicated in the following table for the frequency ranges indicated. Both peak and average field strength components from the table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to Raytheon Model HS.125 Series 700A and 700B airplanes modified by Raytheon Aircraft Services, Inc. Should Raytheon Aircraft Services, Inc. apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate A3EU to incorporate the same or similar novel or unusual design feature, these special conditions would apply to that model as well as under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

This action affects only certain novel or unusual design features on the Raytheon Model HS.125 Series 700A and 700B airplanes modified by Raytheon Aircraft Services, Inc. It is not a rule of general applicability and affects only the applicant which applied to the FAA for approval of these features on the airplane.

The FAA has determined that notice and opportunity for public comment in accordance with 14 CFR 11.38 are unnecessary, because the FAA has provided previous opportunities to comment on substantially identical special conditions and has fully considered and addressed all the substantive comments received. Based on a review of the comment history and the comment resolution, the FAA is satisfied that new comments are unlikely. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

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

The FAA has determined that notice and opportunity for public comment in accordance with 14 CFR 11.38 are unnecessary, because the FAA has provided previous opportunities to comment on substantially identical special conditions and has fully considered and addressed all the substantive comments received. Based on a review of the comment history and the comment resolution, the FAA is satisfied that new comments are unlikely. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

However, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, and views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive as well as a report summarizing each substantive public contact with the FAA personnel concerning these proposed special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this notice between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change the special conditions based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On March 26, 1999, Bombardier Aerospace submitted an application to Transport Canada for type certification of the Bombardier Model BD-100-1A10. On June 28, 1999, Transport Canada made application on behalf of Bombardier for type certification of the Model BD-100-1A10 by the FAA. The Bombardier Model BD-100-1A10 will be type certificated in Canada and in the United States. The Model BD-100-1A10 is a medium-sized transport category airplane, powered by two Allied Signal high bypass turbofan engines mounted on the aft fuselage. Each engine can deliver up to 6,500 pounds of thrust at takeoff. The airplane will be capable of operating with two flight crewmembers and up to 16 passengers.

The Bombardier Model BD-100-1A10 airplane will incorporate an unusual design feature to show compliance with the approach climb requirements of § 25.121(d) (“Climb: One-engine-inoperative”). This design feature is the Automatic Takeoff Thrust Control System (ATTCS). Appendix I to Title 14, Code of Federal Regulations (CFR), part 25, limits the application of performance credit for ATTCS to takeoff. Since the airworthiness regulations do not contain appropriate safety standards for approach climb performance using ATTCS, special conditions are required to ensure a level of safety equivalent to that established in the regulations.

Under the provisions of § 21.17, Bombardier must show that Bombardier Model BD-100-1A10 meets the applicable provisions of 14 CFR part 25, effective February 1, 1965, including amendments 25-1 through 25-98.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , part 25, as amended) do not contain adequate or appropriate safety standards for the Bombardier Model BD-100-1A10 airplane because of novel or unusual design features, special conditions are prescribed under the provisions of § 21.16.

The certification basis also may include later amendments to part 25 that are not relevant to these special conditions. In addition, the certification basis for the Bombardier Model BD-100-1A10 airplane includes the following:

• 14 CFR part 34, effective September 10, 1990, including amendment 34, effective February 3, 1999, and

• 14 CFR part 36, effective December 1, 1969, including amendments 36-1 through 36-23 or through 36-24, as elected by the applicant.

These special conditions form an additional part of the type certification basis. The certification basis also may include other special conditions that are not relevant to these specific special conditions.

If the Administrator finds that the applicable airworthiness regulations (in this case, part 25) do not contain adequate or appropriate safety standards for the Bombardier Model because of a novel or unusual design feature, the FAA may prescribe special conditions under the provisions of § 21.16 (“Special conditions”). The special conditions become part of the type certification basis in accordance with § 21.101(b)(2) (“Designation of applicable regulations”).

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

As stated previously, the Bombardier Model BD-100-1A10 airplane will incorporate an unusual design feature—ATTCS—to show compliance with the approach climb requirements of § 25.121(d). This airplane is powered by two Allied Signal turbofan engines mounted on the aft fuselage and equipped with Full Authority Digital Engine Controls (FADEC) that, in part, protect against exceeding engine limits.

The airplane also incorporates a non-moving throttle system that functions by placing the throttle levers in detents for the takeoff and climb phases of flight or for a go-around; this throttle system allows the FADEC to schedule the power setting, based on the phase of flight. With the ATTCS and associated systems functioning as designed, all applicable requirements of part 25 will be met without requiring any action by the flight crew to increase power.

Automatic takeoff power control on the Bombardier Model BD-100-1A10 airplane involves uptrimming the operating engine to maximum takeoff power. This action will be controlled by the FADEC. At takeoff, when the power levers are set to the Takeoff Go-Around (TOGA) detent, if there are no FADEC fault or failure messages displayed, the system is armed, and ATTCS uptrim will occur without any further action by the crew if an engine fails. During a go-around, the uptrim is automatically armed.

For a go-around, the thrust levers are placed in the TOGA detent. The value of TOGA for the current ambient conditions will be calculated and set by the FADEC. If an engine fails, the ATTCS will change the power reference on the operating engine to achieve the maximum go-around power for the ambient conditions. The propulsive thrust used to determine compliance with the approach climb requirements of § 25.121(d) is limited to the lesser of (i) the thrust provided by the ATTCS system, and (ii) 111 percent of the thrust resulting from the initial thrust setting with the ATTCS system failing to perform its uptrim function and without action by the crew to reset thrust. This requirement serves to limit the performance effects of an ATTCS system failure and ensures that all-engines-operating go-around performance is not significantly degraded.

The engine operating limits (turbine temperature and N1) for TOGA are set and displayed to the pilot when that rating is selected. These limits are set in such a way that the engine redline limits are not exceeded when an ATTCS is engaged. When the maximum takeoff power rating is selected or triggered, the engine limits are reset automatically to reflect the uptrimmed engine redline limits.

The system is armed during all phases of the flight. The power levers will continue to function normally if the ATTCS should fail. Maximum takeoff/go-around power is available if the pilot elects to push the power levers past the takeoff/go-around power detent into the overtravel range.

Operations of all systems and equipment will be designed to function within the engine power range. Thrust increase from the initial to the maximum approved takeoff/go-around power level will be free of hazardous engine response characteristics.

The ATTCS function, as described above, is part of the powerplant control system. The ATTCS is always armed whenever power levers are above the idle detent. The system is verified before each flight via the FADEC built-in test feature. When the ATTCS is triggered following an engine failure, an “APR” message will appear on the engine display.

The FADEC installed on the Bombardier Model BD-100-1A10 airplane will ensure that inherent flight characteristics of the airplane do provide adequate warning, if an engine failure occurs during takeoff. The natural yawing tendency of the airplane, coupled with flashing master warning and master caution lights, will provide the pilot with a clear indication of any engine failure during takeoff.

The part 25 standards for ATTCS, contained in § 25.904 (Automatic takeoff thrust control system (ATTCS)”) and Appendix I, specifically restrict performance credit for ATTCS to takeoff. Expanding the scope of the standards to include other phases of flight, such as go-around, was considered at the time the standards were issued, but flight crew workload issues precluded further consideration. As stated in the preamble to amendment 25-62:

The ATTCS incorporated on the Bombardier Model BD-100-1A10 airplane allows the pilot to use the same power setting procedure during a go-around, regardless of whether or not an engine fails. In either case, the pilot obtains go-around power by moving the throttles into the forward (takeoff/go-around) throttle detent. Since the ATTCS is permanently armed, it will function automatically following an engine failure, and advance the remaining engine to the ATTCS thrust level. Therefore, this design adequately addresses the pilot workload concerns identified in the preamble to amendment 25-62.

Accordingly, these special conditions will require a showing of compliance with those provisions of § 25.904 and Appendix I that are applicable to the approach climb and go-around maneuvers.

The definition of a critical time interval for the approach climb case, during which time it must be extremely improbable to violate a flight path based on the gradient requirement of § 25.121(d), is of primary importance. That gradient requirement implies a minimum one-engine-inoperative flight path capability with the airplane in the approach configuration. The engine may have been inoperative before initiating the go-around, or it may become inoperative during the go-around. The definition of the critical time interval must consider both possibilities.

As discussed above, these special conditions are applicable to the Bombardier Model BD-100-1A10 airplane. Should Bombardier apply later for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

This action affects only certain novel or unusual design features on the Bombardier Model BD-100-1A10 airplane. It is not a rule of general applicability and affects only the applicant that applied to the FAA for approval of these features on the airplane.

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

The Federal Office for Civil Aviation (FOCA), which is the airworthiness authority for Switzerland, recently notified FAA that an unsafe condition may exist on certain Pilatus Models PC-12 and PC-12/45 airplanes. The FOCA reports that drill and/or rivet tool damage could have occurred in areas around the edges of the rear pressure dome during assembly of the Models PC-12 and PC-12/45 airplanes.

Pilatus has received 19 reports of damaged pressure domes. The reported damage included nicks and scratches. This type of damage could also occur on the forward surface of the pressure dome.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Pilatus Models PC-12 and PC-12/45 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on January 14, 2003 (68 FR 1802). The NPRM proposed to require you to inspect the front and rear surfaces of the pressure dome for damage and cracks, and, if necessary, accomplish repairs.

The damage to the pressure dome could result in cracks in the pressure dome and lead to rapid decompression.

The FAA encouraged interested persons to participate in the making of this amendment. The following presents the comment received on the proposal and FAA's response to the comment:

The commenter states that the current wording in the proposed AD is incorrect and implies that the repair scheme will come from FAA. Additionally, the commenter states that the repair scheme will come from the manufacturer; FAA will provide approval of the repair.

We do not concur that the current wording of the proposed AD is incorrect. Since the service information, which is referenced in the proposed AD, does not address repairs for this type of damage, FAA has to individually approve each repair as needed. This gives the manufacturer the option to develop other generic repair procedures, which were not developed at the time of the NPRM, for this type of damage and submit them to FAA for approval. Therefore, we have not changed the final rule AD based on this comment.

We carefully reviewed all available information related to the subject presented above and determined that air safety and the public interest require the adoption of the rule as proposed except for the changes discussed above and minor editorial questions. We have determined that these changes and minor corrections:

We estimate that this AD affects 280 airplanes in the U.S. registry.

We estimate the following costs to accomplish the inspection:

The Luftfahrt-Bundesamt (LBA), which is the airworthiness authority for Germany, recently notified the FAA that an unsafe condition may exist on all Dornier Model 328-100 series airplanes. The LBA advises that, on an affected airplane, a lower torsion spring was found to be loose and an upper torsion spring had migrated. The torsion spring system is part of the rudder tab control and comprises two torsion springs and adapters. The design of the torsion spring and structure adapters could result in a poor fit, allowing the spring to slip through the adapters. Loss of both tension springs, if not corrected, could allow the spring tab to flutter and result in reduced controllability of the airplane.

Dornier has issued Service Bulletin SB-328-27-298, Revision 1, dated November 21, 2002, which describes procedures for installation of a retainer instead of a washer in the upper and lower torsion bars of the rudder tab. Accomplishment of the action specified in the service bulletin is intended to adequately address the identified unsafe condition. The LBA classified this service bulletin as mandatory and issued German airworthiness directive 2003-104, dated April 3, 2003, to ensure the continued airworthiness of these airplanes in Germany.

This airplane model is manufactured in Germany and is type certificated for operation in the United States under the provisions of § 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the LBA has kept the FAA informed of the situation described above. The FAA has examined the findings of the LBA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

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 is being issued to prevent a spring tab torsion bar from slipping through its retaining adaptors, which could result in a loose spring tab; the loss of both tension springs could allow the spring tab to flutter and result in reduced controllability of the airplane. This AD requires installation of a retainer instead of a washer in the upper and lower torsion bars of the rudder tab. The actions are required to be accomplished in accordance with the service bulletin described previously.

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. This material will no longer be included in each individual AD; however, the office authorized to approve AMOCs will be defined 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-102-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) by superseding AD 2002-21-10, Amendment 39-12916 (67 FR 65484, October 25, 2002), which is applicable to PW model 4000 series turbofan engines was published in the Federal Register on April 7, 2003, (68 FR 16736). That action proposed to require interim actions to address engine takeoff power loss events until the HPC case is redesigned and available for incorporation on the PW4000 engines. That action also proposed to add on-wing Testing-21 to engines installed on Boeing 747 and MD-11 airplanes, and add the requirement to install a new RCC rear HPC on engines installed in the Boeing fleet as terminating action to the requirements of this AD.

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 states that proposed paragraph (u)(1)(ii) embeds an engine configuration that is not listed in Table 1 of the proposed AD and requires operators to replace the rear hook regardless of whether or not it is worn beyond serviceable limits. In addition, the commenter states that it is an undue burden on the operators to track and maintain an additional build configuration not previously tracked.

The FAA does not agree. For engines installed on Boeing airplanes, after the effective date of this AD, any time a Segmented Case Configuration (SCC) HPC module is disassembled to a level that separates the HPC rear case assembly from the HPC module at the H flange, the RCC rear HPC must be incorporated making the replacement of the rear hook a non-issue. After May 31, 2006, any SCC HPC engine installed on Boeing airplanes must have incorporated a Haynes material HPC inner case rear hook. This requirement maintains the appropriate safety level and the intent of the fleet management plan to reduce the risk of a group 3 surge event. The FAA does not agree that tracking SCC engines with a Haynes material HPC inner case rear hook as well as RCC HPC engines imposes an undue burden on operators.

One commenter notes that proposed paragraphs (j)(5), (m), (o)(1), (t)(1), (u), (u)(3), and Table (9) reference service bulletin (SB) PW4ENG 72-755, dated February 28, 2003, however the subject SB has been updated to Revision 1, dated April 8, 2003.

The FAA agrees. Since the issuance of the proposed rule, Revision 1 to SB PW4ENG 72-755 was issued on April 8, 2003, to correct various typographical errors, and Revision 2 was issued on May 23, 2003, to change the part number of two brackets due to interference concerns. The FAA has reviewed the data and concurs with these minor changes to the SB. The final rule incorporates SB PW4ENG 72-755, Revision 2, dated May 23, 2003.

Two commenters state that proposed paragraph (m) defines a minimum build standard for Boeing 747 and 767 airplanes that requires an HPC module to incorporate the requirements of SB PW4ENG 72-755. One of the requirements of that SB changes the abradable sealing surface material for the stage 5, 6, and 7 shrouds from felt metal (PWA 24-1) to plasma spray (PWA279), and states that this work should be done by a PW repair facility. The commenters note that Chromalloy Georgia has an FAA-approved procedure for repairing these shrouds with plasma spray and request that the FAA include the alternate Chromalloy Georgia process in the Additional Service Information section of the AD, and in paragraphs (m), (u) and (u)(3).

The FAA does not agree. The AD mandates the incorporation of the RCC HPC into the module in accordance with SB PW4ENG 72-755 and mandates any concurrent requirements of SB PW4ENG 72-755. The other provisions of SB PW4ENG 72-755 may be done by any method, technique, and practice that is either prescribed in the current manufacturer's maintenance manual or Instructions for Continued Airworthiness or is acceptable to the administrator. Thus, the final rule requires only that after the effective date of that AD, the RCC rear HPC must have a plasma spray abradable sealing surface, but does not mandate how that surface must be applied. In this instance, the Chromalloy Georgia procedures numbers 96 CGT 073-08 and 96 CGT 085-05 are acceptable methods for applying plasma spray abradable material for this shroud repair.

Two commenters question the accuracy of the economic analysis. These commenters suggest that the NPRM's economic analysis understated the required parts cost of approximately $119,500 per engine.

The FAA does not agree. The NPRM's economic analysis reflects the average incremental cost of incorporating the RCC per engine during a heavy maintenance HPC compressor shop visit. This is based on the cost of the RCC hardware including the valve and harness changes, and deducts the cost of the SCC overhaul. While the actual cost for an engine may be higher or lower than the $119,500, based on variations between the worldwide overhaul facilities to perform a SCC HPC overhaul and variations of work done in-house by the operator, the FAA believes its use of an average cost fairly estimates the economic burden of this AD.

Three commenters note a typographical error in proposed Table 1, item 9 (Configuration I), where Service Bulletin “PW4ENG 72-55” should read “PW4ENG 72-755”.

The FAA agrees, and has changed the final rule accordingly.

One commenter notes that in proposed paragraph (c) (1) the text of CSN limits should be revised to read “CSN or CST limits”, to eliminate any possible confusion.

The FAA agrees and has changed the final rule accordingly.

One commenter suggests a wording change to proposed paragraph (e)(3) and (e)(4) from “remove from service”, to “remove from service or perform on-wing Testing-21”. The commenter states that this change would highlight that on-wing Testing-21 is an option.

The FAA agrees and has changed the final rule accordingly.

One commenter requests that proposed paragraph (u)(2)(ii) include a reference to PW SB PW4ENG 72-749, Revision 1, dated January 8, 2003, since this SB incorporates the Haynes material HPC inner case rear hook and HPC inner case mid hook.

The FAA agrees and has added a reference to PW SB PW4ENG 72-749, dated June 2002, and Revision 1 of that SB, dated January 8, 2003, as additional methods of compliance to this paragraph as well as paragraph (u)(1)(ii) of the final rule.

Two commenters state that proposed paragraph (o)(2) is too restrictive and will result in numerous requests for alternative methods of compliance (AMOC). The commenters gave examples when the flange between “A” and “T” can be separated, without disturbing the gas path. These commenters request that the FAA remove the requirement for Testing-21 on engines that, during a shop visit, have a flange separation without disturbing the gas path hardware.

The FAA agrees. Paragraph (o)(2) of the final rule has been changed to be less restrictive for engines in the shop that have had a flange separation between “A” and “T” flanges by removing the Testing-21 requirement if, the engine is reassembled with the gas path-related components remaining in the as-removed condition.

One commenter states that in paragraph (l)(2)(i) of the proposed rule, the PW Clean, Inspect, and Repair (CIR) Manual 51A357, Section 72-35-68, Inspection/Check-04, Indexes 8-11, dated September 15, 2001, or dated March 15, 2002, should have only used the March 15, 2002 date.

The FAA does not agree. The final rule retains the September 15, 2001, reference and adds CIR 72-35-68 Insp/Chk-04, Indexes 8-11, dated December 15, 2002, as an additional method to inspect the HPC mid hook and rear hook of the HPC inner case for wear.

One commenter states that proposed Table 1 has serial number errors in the configuration designator “G” where the table identifies the Phase 3, 1st Run Subpopulation Engines by model and serial numbers. The serial numbers for the PW4052, PW4056, PW4060, PW4060A, PW4060C, and PW4062 rating are incorrect. The commenter states that the correct serial numbers should be SN 727732 through SN 728000 inclusive and SN 729001 through SN 729010 inclusive.

The FAA agrees and has changed the final rule accordingly.

One commenter states that the description for configuration designator G in Table 1 of the proposed rule, should be more specific with respect to the Haynes material, and should reference PW4ENG 72-714, dated June 27, 2000; or Revision 1, dated November 8, 2001; or Chromalloy Florida Repair procedure 00CFL-039-0 dated December 27, 2000.

The FAA does not agree. Configuration G engines, listed by serial number, are first run Phase 3 engines produced without Haynes material in the HPC inner case rear hook. Since these engines specifically do not have Haynes material HPC inner case rear hooks, the FAA does not believe it is necessary to list out the PW SBs or Chromalloy Florida Repair procedure. However the wording in the description has been changed for clarification.

One commenter requests that the FAA consider the practice of referencing a document with a specified control date, inclusive of future revisions in an effort to eliminate the errors to NPRMs and the need to request AMOCs when the referenced material is subsequently revised.

The FAA does not agree. The FAA cannot incorporate by reference a document before that document has been published. Therefore, since each revision to a SB is considered a separate document for purposes of incorporation by reference, it is not legally possible for the FAA to approve future revisions before they are published. The FAA will continue to use the AMOC process to approve a later revision of an SB or other service documents incorporated by reference in an AD as an AMOC to the original SB.

One commenter feels it would be more appropriate for the AD to control RCC incorporation based on compressor age, as opposed to a specified date based on forecasted aircraft utilization.

The FAA does not agree. The compliance dates within the final rule use the current average airplane and engine utilization rates for the total fleet. If an operator has a utilization rate outside of this average, the operator can use the AMOC process to seek relief. The risk accumulation of the operator's fleet would be evaluated against the risk model predictions of the total fleet.

One commenter suggests that this final rule include the incorporation of the RCC rear HPC as terminating action for engines installed on the Airbus fleet.

The FAA does not agree. The FAA is currently evaluating proposals for terminating actions for Airbus and McDonnell Douglas fleets. Once those proposals are found to meet the airworthiness standards for both engines and transport category aircraft, the FAA will incorporate those terminating actions into this AD. The FAA believes, however, that the current rule should be revised now in order to maintain the desired level of safety based on the fleet-wide risk analysis.

One commenter states that the applicability section of the proposal does not include the PW4062A model engine. Since this engine is currently used on the Boeing 747-400F airplane and is subject to takeoff power losses due to HPC surges, this commenter requests that this model be included in the applicability section.

The FAA does not agree. The PW4062A engine model is intentionally not added to the applicability section of this AD. The amended Type Certificate adding the PW4062A model included as part of the PW4062A design the interim measures applied to other engine models to address this known high power surge issue. Those measures appear in the Limitation Section of Chapter 5 in the PW4062A Engine Manual. The terminating action for PW4062A model engines installed on Boeing aircraft, the installation of a ring case compressor (RCC), will be addressed in a separate AD that applies to the PW4062A model. The FAA will consider adding the PW4062A engine model to this AD in the future once terminating action is developed and approved for the Airbus and McDonnell Douglas fleets.

One commenter notes that proposed paragraph (m) does not include the minimum build HPT/HPC mismatch requirement, or the incorporation of SB PW4ENG 72-514, both previously mandated for the SCC HPC engines installed on Boeing airplanes. This commenter points out that it is feasible to have a SCC HPC engine enter the shop, have no work done to the HPC, and be returned to a Boeing airplane. This commenter questions whether these omissions were an oversight.

The FAA agrees that these omissions were an oversight. While the HPC/HPT mismatch or SB PW4ENG 72-514 minimum build standard requirements are not required for RCC HPC engines, the FAA intended that these two requirements form part of the minimum build standard for all SCC HPC engines, regardless of whether the engine is installed on Boeing, Airbus or MD-11 airplanes. Therefore, the FAA revised paragraph (m) of the final rule to include these two requirements for the SCC HPC engines installed on the Boeing fleet.

One commenter states that the compliance of proposed paragraph (m), which requires the ring case incorporation when the HPC module is disassembled to a level that separates the HPC rear case assembly from the HPC module at the H flange, is more restrictive than the PW SBs compliance category 6. This commenter requests that paragraph (m) define the compliance to be the same as a PW SB compliance category 6.

The FAA agrees. It was intended that the compliance for paragraph (m) of the AD be equivalent to a PW SB compliance category 6. Therefore, for clarification, the FAA has added the word “fully”, to paragraphs (m) and (u) of the final rule, to clarify that a fully separated H flange from the HPC module is the same as PW SB compliance category 6.

One commenter requests that the FAA allow one or two months of drawdown time from the effective date of the AD, for RCC incorporation. The commenter asks that the FAA consider that some operators may not be ready to do the incorporation by the time the AD is in effect.

The FAA does not agree. The final rule will not be effective until 30 days after publication, providing adequate time to prepare to comply with this AD.

One commenter asks the FAA to consider as an addition to proposed paragraph (u)(2)(i) to allow two SCC HPC engines on an airplane after January 31, 2007, provided that the Testing-21 interval be reduced in half, to 400 hours-since-last-test. The commenter suggests that the reduced interval can account for an additional SCC HPC engine installation.

The FAA does not agree. Proposing two SCC HPC engines on-wing after January 31, 2007, with a Testing-21 interval reduction by half, results in a dual engine group 3 surge risk greater than the FAA proposal. Since the commenter's proposal does not have an equivalent risk to the requirement of proposed (u)(2)(i), the FAA has not made this change.

In addition, the FAA has added clarification to proposed paragraph (f) to ensure that the intent of this AD is, after the effective date, to allow only new Airbus operators to apply the initial categorization criteria of proposed paragraphs (f)(1) through (f)(9). Those operators who have complied with paragraph (f) in accordance with the current AD, AD 2002-21-10, should not re-apply paragraphs (f)(1) through (f)(9) of the final rule after the effective date of this AD.

Since the issuance of the NPRM, service documents PW SB PW4ENG 72-714, Revision 2, dated February 28, 2003; PW SB PW4ENG 72-749, Revision 1, dated January 8, 2003; PW SB PW4ENG 72-755, Revision 2, dated May 23, 2003; PW CIR PN51357, Section 72-35-68, Inspection/Check-04, Index 8-11, dated December 15, 2002, and PW4000 EM 50A605, 71-00-00, Testing 21, dated June 15, 2003, and, have been issued as revisions to service documents referenced in the proposed rule. The FAA has reviewed and approved these documents, has added them to the appropriate compliance paragraphs as additional methods of compliance, and has added them to the list of documents that have been incorporated by reference.

The manufacturer has submitted data which supports removing from the final rule CIR 51A357, Section 72-35-68, Repair-16, which is an HPC inner rear case mid hook Greek Ascoloy weld repair. Currently, the existing AD allows the repair of the HPC inner mid hook using either Greek Ascoloy or Haynes material. Service Bulletin PW4ENG 72-749 replaces both the HPC inner rear case mid hook and inner case rear hook with hooks made of Haynes material. There is evidence that indicates that the best configuration for a SCC HPC inner rear case is to have Haynes material mid and rear hooks. The FAA has reviewed the data, and based on the incorporation of the RCC HPC modules, believes this configuration has low impact on the fleet. Therefore, proposed paragraph (l)(2)(i) has been revised to remove CIR 51A357, Section 72-35-68, Repair-16.

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 described previously. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the 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.

A final rule AD, FR Doc. 03-13115 applicable to Turbomeca Turmo IV A and IV C series turboshaft engines, was published in the Federal Register on May 29, 2003 (68 FR 31970). The following correction is needed:

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 93-21-04, amendment 39-8801 (59 FR 2952, January 20, 1994), which is applicable to certain Bombardier Model CL-600-2B19 (Regional Jet series 100) series airplanes, was published in the Federal Register on January 13, 2003 (68 FR 1566). The action proposed to require repetitive lubrication of the slide shaft of the input plunger of the brake control valve assembly; modification of the brake control valve assembly, which would terminate the repetitive lubrications required by the existing AD; and subsequent repetitive lubrications of the valve utilizing the grease fittings that are installed during the modification.

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 proposed AD be revised to either remove the reference to “Regional Jet Series 100” in association with the affected airplanes throughout the document or add a reference to series 440 airplanes. The commenter explains that the proposed AD applies to Model CL-600-2B19 airplanes. The type certificate data sheet (TCDS) identifies the affected airplane model as “CL-600-2B19 (Regional Jet Series 100 & 440).” The commenter suggests that the references to this airplane model should be revised to reflect both the 100 and 440 series.

The FAA concurs with the request. After the proposed AD was issued, the TCDS was revised to incorporate this change. The final rule has been revised accordingly to correctly identify the affected airplanes where appropriate.

Paragraph (c) of the proposed AD proposed to require repetitive lubrication of the brake control valve in accordance with Bombardier Service Bulletin 601R-32-017. One commenter requests that the proposed AD be revised to instead require incorporation of the lubrication task (task 32-43-06-05 of the CL-600-2B19 Maintenance Requirements Manual (MRM)) into the approved maintenance program. The commenter asserts that the lubrication task, if incorporated into the MRM, would be considered a routine task subject to normal maintenance program development and escalation. The commenter adds that incorporating the task into the MRM would terminate the repetitive lubrication requirements specified in the proposed AD.

The FAA does not concur with the request. An AD's requirements are mandated for all affected airplanes, but the applicable section of the MRM (Part 1, CSP A-053) is not approved by the FAA (although it is “accepted”). Consequently, the FAA does not control revisions to Part 1 of the MRM. If a task were to be subsequently altered or deleted, the intent of the AD would then become nullified. However, under the provisions of 14 CFR 39.19 and paragraph (d)(1) of this AD, an operator may request approval of an alternative method of compliance (AMOC) to allow use of a particular task card for this AD. However, the AMOC granted would require adherence to a particular revision of the task card; use of any subsequent revisions would require a new AMOC request and approval to enable the cognizant ACO to determine that the intent of the AD requirement has not been altered. No change to the final rule is necessary regarding this issue.

Certain portions of the preamble and paragraph (b) of this final rule have been revised to clarify that the modification includes applying grease to the grease fittings that are installed during the modification.

The repetitive lubrication interval was clarified in paragraph (c) of this final rule. Whereas the proposed AD specified that the lubrication be done “at intervals of 1,500 flight hours,” this final rule will require that the lubrication be done “at intervals not to exceed 1,500 flight hours.”

Paragraph (d)(2) has been revised in this final rule to clarify that AMOCs approved previously in accordance with AD 93-21-04 are approved as alternative methods of compliance with paragraph (a) of this AD only.

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. Because we have now included this material in part 39, we no longer need to include it in each individual AD; however, the office authorized to approve AMOCs is identified in paragraph (d)(1) of this AD.

The FAA estimates that 2 airplanes of U.S. registry are affected by AD 93-21-04. The actions that are currently required by that AD take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions is estimated to be $60 per airplane.

Approximately 194 airplanes of U.S. registry will be affected by this AD.

The modification required by this AD will take approximately 4 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will cost approximately $3,812 per airplane. Based on these figures, the cost impact of the modification on U.S. operators is estimated to be $786,088, or $4,052 per airplane.

The lubrication of the brake control valve required by this AD will take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this action on U.S. operators is estimated to be $11,640, or $60 per airplane, per lubrication.

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.

Phoenix Scientific, Inc., 3915 South 48th St. Terrace, St. Joseph, MO 64503, filed ANADA 200-319 that provides for use of Acepromazine Maleate (acepromazine maleate) Injection as a tranquilizer. Phoenix Scientific's Acepromazine Maleate Injection is approved as a generic copy of Fort Dodge Animal Health's PROMACE Injectable approved under NADA 015-030. The ANADA is approved as of March 25, 2003, and the regulations are amended in 21 CFR 522.23 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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.

These temporary regulations incorporate the phrase “return information reflected on returns” into § 301.6103(j)(5)-1 in conformance with the statutory language that describes the type of return information that the IRS may disclose to the Department of Agriculture under section 6103(j)(5) of the Code. These temporary regulations are consistent with a recent clarification of the same phrase ( i.e. , return information reflected on returns) in § 301.6103(j)(1)-1, involving the disclosure of return information to the Bureau of the Census. See 68 FR 2691.

Also, currently § 301.6103(j)(5)-1 provides an itemized description of the return information authorized for disclosure in conjunction with the census of agriculture. These temporary regulations remove certain items of return information currently listed in § 301.6103(j)(5)-1 that the Department of Agriculture no longer needs in conjunction with the census of agriculture.

These temporary regulations adopt the phrase “return information reflected on returns” in lieu of the phrase “return information” that currently appears in § 301.6103(j)(5)-1. (The phrase “return information reflected on returns” encompasses the phrase “return information reflected thereon” in section 6103(j)(5) of the Code.) These temporary regulations clarify the phrase “return information reflected on returns” by explaining that the phrase includes, but is not limited to, information on returns, information derived from processing such returns, and information derived from other sources for the purposes of establishing and maintaining taxpayer information relating to returns. The phrase includes information derived from returns, monthly corrections of, and additions to, taxpayer information contained in IRS databases ( e.g. , taxpayer address and name changes) that are obtained from other sources, and computer codes the IRS derives from returns and/or tax forms and integrates within taxpayer data bases.

On March 4, 2003 and March 17, 2003, the Department of Agriculture's National Agriculture Statistics Service (NASS) notified the IRS that certain items of return information that are currently listed in § 301.6103(j)(5)-1 are no longer needed in conjunction with the census of agriculture. Specifically, the Department of Agriculture no longer needs the following items currently extracted from IRS forms: (1) From Form 1040, Schedule F (Profit or Loss from Farming): sales of livestock and produce raised; (2) From Form 1120 series: Parent corporation Employer Identification Number, and related Name and Principal Business Activity (PBA) code for entities with agricultural activity; and (3) From Form 851 (Affiliations Schedule): subsidiary taxpayer identity information, annual accounting period, subsidiary PBA code, parent taxpayer identity information, parent PBA code, Master File Tax Code, Document Locator Number, and cycle posted. As a result, these items of return information currently listed in § 301.6103(j)(5)-1 will be removed by this document.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because no preceding notice of proposed rulemaking is required for this temporary regulation, the provisions of the Regulatory Flexibility Act (5 U.S.C. chapter 6) do not apply. Pursuant to section 7805(f) of the Code, the IRS will submit this Treasury decision to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Christine Irwin, Office of the Associate Chief Counsel, Procedure & Administration (Disclosure & Privacy Law Division).

On December 19, 2002, the Postal Service published a proposed rule in the Federal Register (67 FR 77726-77737) that proposed revisions to the standards in DMM C023 for mailing Division 6.2 infectious substances. The proposal was initiated to align the Postal Service standards with the DOT Federal regulations in 49 CFR and to make other minor changes and clarifications to the related mailing standards in DMM C021, C023, C024, C050, and F010.

Part A of this document provides background information on why the Postal Service needs to adopt these changes. Part B identifies and responds to the comments received by the Postal Service on the proposed rule. Part C summarizes the changes adopted by the Postal Service in this final rule. The actual changes to the DMM appear at the end of this final rule.

The carriage of U.S. mail by the United States Postal Service (Postal Service) is regulated by Title 39 Code of Federal Regulations (39 CFR). Unlike commercial carriers, the Postal Service is not subject to the Federal regulations of the U.S. Department of Transportation (DOT) in Title 49 Code of Federal Regulations (49 CFR). The Postal Service is, however, subject to the legal restrictions in Title 18 United States Code 1716 (18 U.S.C. 1716) which prohibits the mailing of * * *“ all disease germs, or scabs, and all other natural or artificial articles, compositions, or material which may kill or injure another, or injure the mails or other property”* * * if that matter is outwardly or of its own force dangerous to life, health, or property. Accordingly, for legal and safety reasons, the mailing standards for hazardous materials in the Domestic Mail Manual (DMM) not only closely adhere to the DOT regulations in 49 CFR, but also include many additional limitations and prohibitions.

In many instances, the Postal Service standards are more restrictive than the DOT requirements that apply to shipments being transported in domestic commerce. As an example, commercial shippers are permitted under the DOT regulations in 49 CFR to send certain types of flammable materials via air transportation. In contrast, the Postal Service prohibits the mailing of all flammable materials via air transportation.

Under Postal Service mailing standards, most hazardous materials are nonmailable. With few exceptions, the Postal Service generally limits the mailing of hazardous materials to only those materials that can be reclassified as an ORM-D material under the DOT Federal regulations in 49 CFR 173.144 and that can be renamed with the proper shipping name of “Consumer Commodity.” Additionally, mailable hazardous materials must meet the Postal Service quantity and packaging requirements, which in many instances are more restrictive than the DOT requirements in 49 CFR. Of all regulated hazardous materials, ORM-D materials present the lowest level of risk during handling and transportation.

Over the past few years, the Postal Service has encountered increasing difficulties with the commercial carriers who are contracted to provide air transportation services for the carriage of U.S. mail. Many carriers have refused to transport mailpieces containing mailable hazardous materials. In some instances, an air carrier has established a corporate policy not to carry hazardous materials. In other cases, an air carrier has refused to carry a specific type of hazardous material ( e.g. , diagnostic specimens) because Postal Service packaging standards, which met Federal standards, did not meet the international standards followed by the air carrier industry.

To ensure an acceptable level of safety and to facilitate domestic and international transportation, the Postal Service is adopting some of the regulatory and packaging changes for Division 6.2 infectious substances that DOT adopted as revisions to 49 CFR in the Federal Register (67 FR 53117-53144 and 67 FR 54967). The DOT changes are consistent with the current international standards found in the Technical Instructions for the Safe Transport of Dangerous Goods published by the International Civil Aviation Organization (ICAO).

It should also be noted that many of the DOT Federal regulations in 49 CFR involve requirements for the transport of hazardous materials that have moderate, high, or very high risk levels and that are shipped in very large quantities (exceeding 70 pounds in weight). Such hazardous materials are not permitted in the U.S. mail due to the legal restrictions in 18 U.S.C. 1716, concerns for employee and public safety, and Postal Service size and weight limitations. Accordingly, the Postal Service is adopting only the DOT regulations for Division 6.2 infectious substances that apply to materials that can be safely handled in the U.S. mail. As an example, the Postal Service will not adopt the new DOT bulk packaging options for regulated medical waste because under DOT regulations in 49 CFR, a bulk packaging is defined as a receptacle that has a capacity greater than 450L (119 gallons) for liquid materials or a net mass greater than 400 kg (882 pounds) for solid materials. As established by law, the maximum size and weight limits per mailpiece are 70 pounds and 108 inches in combined length and girth (130 inches for Parcel Post). A bulk packaging receptacle as defined by DOT is nonmailable in the U.S. mail because it exceeds the maximum size and weight limits for mailing and it also would pose an unacceptable risk level during Postal Service transport and handling.

On December 19, 2002, the Postal Service published a proposed rule in the Federal Register (67 FR 77726-77737) that provided information on the revisions to the mailing standards in the DMM that the Postal Service proposed to adopt. The Postal Service solicited comments on the proposed rule from members of the general public and responses were received from nine parties. The parties represented: four authorized sharps mailers; three commercial medical laboratories that process diagnostic (clinical) specimens received through the mail; one institute comprised of two separate trade associations that represented members involved in private waste services and manufacturing businesses; and one law firm representing a group of manufacturers of healthcare products.

The comments received generally fell into one of the following four categories: comments on the proposed effective date; comments on the proposed rules for diagnostic (clinical) specimens; comments on the proposed rules for mailable types of regulated medical waste and sharps waste; and comments in support of the Postal Service proposed rule. A summary of the comments grouped by category is detailed in items 1 through 4.

Four commenters, including three of the sharps mailers and the institute, opposed the Postal Service proposal of an effective date of April 30, 2003. Two of the sharps mailers requested an effective date of six months after the date of the final rule, while the other two commenters requested an effective date of one year after the date of the final rule. All commenters felt that a delayed effective date was needed to allow them and their clients a sufficient amount of time in which to use up preexisting packaging that is already in circulation. The Postal Service agrees that a phase-in period is needed and in this final rule has adopted an effective date of June 12, 2003, with a phase-in period through January 1, 2004. This phase-in period will allow for mailer implementation of the new packaging requirements for diagnostic (clinical) specimen mailpieces using a business reply mail format and regulated medical waste or sharps waste mailpieces using a merchandise return service format.

Four commenters, including the three medical laboratories and the law firm, submitted comments related to the proposed requirements for clinical specimens.

Two of the medical labs and the law firm all maintained that the Postal Service proposal to require placement of the biohazard symbol on the primary container of a Risk Group 1, 2 or 3 diagnostic (clinical) specimen was impractical. They noted that mailers would incur added costs to place the symbol on the primary container. One commenter also noted that under the Federal requirements issued by the U.S. Department of Occupational Health and Safety Administration (OSHA), the biohazard symbol is required to appear on the secondary container. For these reasons, in this final rule the Postal Service has changed the placement requirement for the biohazard symbol on Risk Group 1, 2, and 3 specimens. For mailable types of Risk Group 1, 2, and 3 specimens, the biohazard symbol is required to appear on the secondary packaging, except in the instance where the secondary packaging also serves as the outer shipping container for a Risk Group 1 specimen. In that instance, then the biohazard symbol must appear on the inner packaging or on the primary container. The biohazard symbol must not appear on the outer shipping container of a mailable Risk Group 1, 2, or 3 specimen.

One of the medical labs opposed the Postal Service proposal to include diagnostic (clinical) specimens in the description of Division 6.2 materials in DMM C023.8.1 because they felt it could be confusing to most mailers. The text in DMM C023.8.1 is intended to generally identify the items that are described under the category of Division 6.2, some of which are regulated as infectious substances, and some of which are not. The definition of a Division 6.2 material (infectious substance) is defined in DMM C023.8.2a, and that definition very closely mirrors the definition adopted by DOT in 49 CFR. The Postal Service does not feel that the general explanation in DMM C023.8.1 is confusing or misleading, but has made some minor changes to the text in the final rule for the purpose of clarity.

The same medical lab also asked whether it was the intent of the Postal Service to mirror the risk group classifications adopted by DOT. The answer is yes. The Postal Service believes this intent was clearly stated in the proposed rule, and it is also restated in Part C of this final rule. This commenter also asked whether the Postal Service classified all diagnostic (clinical) specimens collected for insurance purposes or through drug testing programs as Risk Group 1 materials. The Postal Service cannot make such a determination. In the proposed rule and in this final rule, the Postal Service has placed the responsibility for the proper determination of the Risk Group on the sender ( i.e. generally the health care professional or individual who collects the specimen) as stated in DMM C023.8.2f. The Postal Service position on this point is in alignment with the stance DOT adopted in 49 CFR. The Postal Service suggests that packaging distributors include information to inform the collector of the specimen that the packaging may only be used to send Risk Group 1 specimens and that different packaging with stricter requirements must be used to send Risk Group 2, 3, or 4 specimens.

Another one of the medical labs that provided comments requested that the Postal Service clarify what materials are acceptable for a primary and secondary container holding a dry specimen. They also asked the Postal Service to clarify what would constitute a “securely sealed” primary receptacle in DMM C023.8.10b. Unlike the DOT regulations, the Postal Service proposed packaging requirements for dry clinical specimens since these types of specimens are routinely sent through the U.S. mail. Dry specimens often include materials such as saliva swabs, dried blood spots, and fecal smears. In the final rule, the Postal Service has made a few minor changes to the text for packaging a dry specimen in order to clarify the requirements. The Postal Service believes these changes are sufficient.

Five parties, including the four sharps mailers and the institute, submitted comments related to the proposed changes affecting the mailing of regulated medical waste and sharps waste. For Postal Service purposes, regulated medical waste is defined in DMM C023.8.2e and sharps waste is defined in DMM C023.8.2g.

All four sharps mailers opposed the Postal Service proposal to limit the capacity of a sharps primary receptacle to a maximum of 3 gallons. Two commenters requested a limit of 5 gallons, one requested a limit of 11 gallons, and the other specified no maximum limit. Over the past few years, the Postal Service has experienced instances in which mailpieces containing sharps waste and having a 5-gallon primary receptacle have been found broken open in the mailstream. Although the number of incidents is small, the Postal Service believes that when properly designed and packaged prior to mailing, no approved sharps container should break open while in the mailstream. It was for this reason, and to ensure the safety of postal employees who handle these mailpieces, that the Postal Service proposed the new design requirement. The Postal Service does not agree with the commenters that a primary receptacle used to collect sharps (and designed for return via the U.S. mail) needs to be larger than 3 gallons in capacity. Most sharps container systems previously approved by the Postal Service have a primary receptacle with a capacity of less than 1 gallon. Primary receptacles having a capacity of 3 gallons or greater are not generally used to collect sharps waste for mail-back purposes, rather they are used to collect other types of nonsharps waste. Accordingly, the Postal Service will adopt a 3-gallon limit for a primary receptacle used to collect sharps waste as defined in DMM C023.8.2g and a 5-gallon limit for a primary receptacle used to collect regulated medical waste as defined in DMM C023.8.2e.

One sharps mailer opposed the Postal Service proposal to change the requirements for the secondary container for regulated medical waste and sharps waste packaging systems. The same sharps mailer also opposed the Postal Service proposal to prohibit easy-fold bottoms on outer shipping containers if they are not reinforced with a water-resistant tape. The commenter felt that the previous Postal Service requirement which allowed a secondary container to consist of a 3 mil plastic bag with a reinforced fiberboard sleeve (open on the top and bottom) was sufficient. They also felt that requiring a reinforced bottom on the outer shipping container was unnecessary and would increase their production costs. The Postal Service feels these changes are necessary for safety reasons. At least two incidents have occurred in which the bottom of an auto-fold style outer shipping container gave way during postal handling causing the bagged primary receptacle to slide out of the reinforced sleeve and through the bottom of the outer shipping container. In this situation, the only level of protection from the primary container was the 3 mil plastic bag, which increased the safety risk to postal employees. For this reason, the Postal Service adopts the packaging change for regulated medical waste and sharps waste mailpieces that requires the secondary container be completely enclosed in a watertight container or containment system. The secondary container may consist of more than one component. If one of the components is a plastic bag, it must be at least 3 mil thick and be used in conjunction with a strong and securely sealed fiberboard box. A plastic bag by itself will not meet the requirement for a secondary container. The Postal Service also adopts the packaging change for regulated medical waste and sharps waste mailpieces to require that the bottom of the outer shipping container and all joints and flaps be securely taped, glued, or stitched to maintain the integrity of the container. When tape or glue is used to secure an outer shipping container, the material must be water-resistant.

One sharps mailer and the institute commented that the Postal Service proposed definition of “regulated medical waste” should also include sharps. Both felt that the Postal Service should not maintain a separate category for sharps waste since DOT had no such distinction. One commenter further stated that if sharps waste were included in the definition of regulated medical waste, then the Postal Service would only need one set of packaging requirements and mailers would not have to use different marking requirements for mailpieces containing regulated medical waste and sharps waste. The Postal Service does not agree with those arguments. Since the Postal Service began allowing medical waste in the mail more than ten years ago, there has been, and continues to be, a great deal of concern involving the potential dangers associated with sharps waste should package failure occur during postal handling. The Postal Service has experienced a few instances in which a used syringe was found protruding from a sharps waste mailpiece that was not properly packaged prior to mailing. For this reason, the Postal Service will continue to maintain separate categories for sharps waste and other mailable types of regulated medical waste. This distinction will include separate requirements for the primary receptacles and different marking requirements for the outer shipping container. The Postal Service does not feel this will present a hardship on mailers since many already design and market their waste container systems for specific uses. It can also be noted that healthcare professionals generally do not mix sharps waste in the same containers used to collect other nonsharps medical waste.

Although not proposed by the Postal Service, one sharps waste mailer recommended the Postal Service require that sharps container systems be tested by “certified” labs, rather than by independent labs, as already permitted in DMM C023.8.7d. The Postal Service has not noted any significant problems with the use of independent labs, and therefore, sees no reason to adopt this recommendation. The problems associated with package failure of sharps waste container systems appear to be caused by container system design or the improper assembly of the container system by the end user prior to mailing.

The institute recommended that the Postal Service establish a “performance-based” standard for packaging rather than adopt new requirements for sealing the outer shipping container. The institute further suggested that the Postal Service allow a manufacturer or distributor to prove that their packaging material is safe when placed in the mail. We believe the commenter misinterpreted our intent and might not be aware of the preexisting requirements for package testing. The Postal Service has always required that packaging systems for sharps waste be tested by an independent testing facility using several of the tests detailed in 49 CFR part 178. Because the Postal Service has not experienced any significant problems with the test reports provided by the independent testing facilities, we do not feel there is a need to change the previously existing requirements for package testing. Additionally and as stated previously, the Postal Service will adopt new securing requirements for the outer shipping container to further reduce the potential for package failure during postal processing. The adoption of this requirement is directly related to specific instances of package failure that have occurred during postal handling.

The institute also recommended the that Postal Service require the assembly instruction sheet for each sharps container system also include a customer service telephone number for the end user to call if they need assistance or find a component part is missing. Although the Postal Service did not include this requirement in the proposed rule, it will adopt a variation of it in this final rule. The adopted text will require that each assembly sheet for a sharp waste or regulated medical waste container system list a customer service telephone number or provide specific information on where such a telephone number is located elsewhere on the container system. The Postal Service does not feel this will present a hardship for mailers, since many already display a customer service phone number on their assembly instruction sheets. The adoption of this requirement will help provide one more support level to the third-party end user who is being relied on to properly assemble the container system before depositing it into the mail. Proper assembly of a sharps container system prior to mailing is critical to ensuring it will be safely handled and transported without deterioration or package failure.

The institute further recommended that the Postal Service discontinue the use of the term “waste manifest” in the requirements that apply to the mailing of sharps waste and replace the term with “shipping paper.” The Postal Service did not propose this change and feels it is unnecessary. The text in DMM C023.8.7c(3) states that the waste manifest serves as the shipping paper. In addition, such a change could pose a hardship for regulated medical waste and sharps waste mailers who presently identify this document as a waste manifest, by causing them to incur the cost for redesigning and replacing the documents.

Seven of the commenters, including three sharps mailers, two medical labs, the institute, and the law firm, submitted comments that supported some of the requirements in the Postal Service proposed rule. Those comments are summarized in this section.

Two of the sharps mailers stated that they did not oppose the Postal Service proposal to limit the maximum weight of a mailpiece containing regulated medical waste or sharps waste to 25 pounds. Another further stated that, in general, they supported the Postal Service proposed rule.

One medical lab stated they were pleased with the Postal Service changes that would improve packaging integrity and they supported them. The commenter further stated that they approved of the text in DMM C023.8.10a that included the phrase “* * * for drug testing programs or for insurance purposes * * *” within the definition of the term diagnostic (clinical) specimen. The commenter stated that the slightly stricter packaging requirements would help to ensure their receipt of safely packaged specimens.

Three commenters, including one medical lab, the institute, and the law firm, supported the Postal Service effort to align the mailing standards with the DOT regulations in 49 CFR. These commenters felt that harmonization of the packaging requirements among all agencies and regulators would be a positive benefit for all mailers and shippers.

The institute also stated that they recognized and supported the continued role of the Postal Service in providing mailing options for senders of infectious substances and mail-back systems.

One medical lab stated they appreciated the Postal Service proposal to provide specific packaging requirements for dry specimens. They further noted they supported the development of mailing standards that benefit both the industry and the Postal Service.

In this final rule, the Postal Service adopts the following changes to the mailing standards in DMM C023.8.0 for Division 6.2 infectious substances:

• New classification criteria for Division 6.2 infectious substances based on the defining criteria developed by the World Health Organization (WHO) and consistent with the DOT Federal regulations in 49 CFR for domestic transport and the International Civil Aviation Organization (ICAO) technical instructions for international transport.

• New DOT packaging requirements that are applicable to the mailable types of Division 6.2 materials and consistent with the ICAO technical instructions. For safety reasons, in some instances the Postal Service volume limits are lower than the DOT limits.

• New DOT Federal requirements that regulate diagnostic (clinical) specimens in Risk Groups 2, 3, or 4 as hazardous materials.

• New DOT Federal requirements that do not regulate certain Risk Group 1 materials, including diagnostic (clinical) specimens, as hazardous materials.

• Revisions and modifications in the DOT Federal regulations related to the definitions of Division 6.2 materials and clarification of the use of the biohazard symbol on regulated and nonregulated material.

In addition, the Postal Service is adopting a few minor clarifications and changes to the hazardous materials standards in DMM C023 and certain related standards in DMM C021, C023, C024, C050, and F010. These changes will improve clarity in the standards and reduce misunderstandings. They will also improve packaging integrity for mailable types of regulated medical waste and sharps waste, and provide a greater level of safety during handling for both Postal Service employees and the public. These changes include:

• Minor revisions to the text in DMM C021 to improve clarity.

• Minor clarifications to the definitions in DMM C023.1.1 including added text in the definition for “air transportation requirements” to note that the Postal Service does not guarantee air transportation service for any class of mail. Air transportation service is usually provided for First-Class Mail®, Priority Mail®, and Express Mail® destined to zones 5 through 8; however, air transportation service is dependent on the ability of the Postal Service to procure an air carrier.

• Standardization of the terminology used in DMM C023 for identifying the different components required for the proper packaging of mailable hazardous materials.

• Expansion of the requirements in DMM C023.8.0 to establish that mailable types of regulated medical waste are subject to the same authorization requirements as sharps waste.

• Clarifications and minor changes to the requirements in DMM C023.8.0 for regulated medical waste and sharps waste containers to enhance the accuracy of the regulations and reduce misunderstanding of the standards. In addition, the Postal Service adopts additional limitations for regulated medical waste and sharps waste containers to ensure packaging integrity during Postal Service handling and to provide a greater level of safety for Postal Service employees and the public.

• Standardization of the maximum weight limit in DMM C023 for several different types of mailable hazardous materials as 25 pounds or less. This change affects nonflammable compressed gases, matches, regulated medical waste, sharps waste, and nonspillable wet batteries.

• Reinstatement of former DMM C024.18.0 (DMM Issue 56) with revised text to clarify the mailability of odd-shaped items in paper envelopes and to support the restrictions for harmful matter in DMM C021. Additional clarifying text is also added to DMM C050.2.2d.

• Revisions to DMM F010 that prohibit the use of the ancillary service endorsement “Change Service Requested” on Priority Mail, First-Class Mail, Standard Mail, and Package Services mail containing mailable hazardous materials under DMM C023. Also, a revision to require a return or forwarding endorsement on Standard Mail containing mailable hazardous materials.

These changes are effective June 12, 2003. However, mailers are provided with a phase-in period through January 1, 2004, for implementation of the new packaging requirements for diagnostic specimen mailpieces using a business reply mail format and medical waste mailpieces (including sharps waste) using a merchandise return service format. This time period will allow mailers to exhaust any existing packaging stock already in circulation.

The Postal Service believes that the adoption of the changes in this final rule will help to ensure an acceptable level of security and safety during Postal Service handling for the limited types and quantities of hazardous materials that are permitted in the U.S. mail.

Based on the proposed rule, and after careful consideration of the comments received, as described above, the Postal Service adopts the following changes to the Domestic Mail Manual, which are incorporated by reference in the Code of Federal Regulations. See 39 CFR part 111:

On April 16, 2001, the North Carolina Department of Environment and Natural Resources submitted a revision to the North Carolina State Implementation Plan (SIP) modifying rule 15A NCAC 2D .0521 Visible Emissions. These revisions include an exemption to this rule for engine maintenance and testing controls where visible emissions controls are infeasible.

Additionally, rule .0521 is being amended to establish an equitable reasonable procedure for sources using continuous opacity monitors (COM) to show compliance with the visible emission standard. This amendment is designed to provide sources using COMs the same opportunity to comply with the visible emissions rule as sources that do not use COM devices. Under the previous rule, the opacity is violated if two six minute averages exceed the standard in one hour or if five six-minute averages exceed the standard in 24 hours. Under the new amendment, sources with COMs are allowed to exceed the current opacity limit for up to .8 percent of the total operating hours without violating the visible emissions rule. Exceedances of the opacity limit greater than .8 percent of the total operating hours will be considered a violation of this rule.

In a letter dated March 29, 2002, EPA provided comments to North Carolina explaining the additional requirements that must be met in order for EPA to approve this rule. These requirements included the submittal of a worst case demonstration proving that such an exemption would not violate the National Ambient Air Quality Standards. On July 10, 2002, North Carolina submitted this demonstration to EPA. After a detailed review of this demonstration, EPA finds that North Carolina's amendments to rule .0521 Visible Emissions are approveable.

In addition to the revision being addressed within this notice, several other revisions were contained in this submittal and approved in 67 FR 51527. The additional revisions included the adoption of rules 15 NCAC 2Q .0316 and .0317, and the amending of rules .0109, .0803 and .0805 through .0808.

EPA is approving the aforementioned changes to the SIP because the revisions are consistent with Clean Air Act and EPA regulatory requirements. The EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective August 5, 2003, without further notice unless the Agency receives adverse comments by July 7, 2003.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 5, 2003, and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 5, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

You may be potentially affected by this action if you are a Federal or State government agency involved in administration of environmental quality programs. Potentially affected entities may include, but are not limited to:

•Federal or State Government Entity, (NAICS 9241), i.e., Departments of Agriculture, Environment, etc.

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-2003-0002. 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.

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.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing time-limited exemptions from the requirement of a tolerance for residues of thymol and eucalyptus oil in or on honey and honeycomb. These time-limited exemptions from the requirement of a tolerance for residues of the thymol and eucalyptus oil will expire and are revoked on June 30, 2005. EPA will publish a document in the Federal Register to remove the revoked exemptions from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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) 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....”

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The varroa mite is an ectoparasite of honey bees. It was first detected in the continental United States in Maryland in 1979, and found in Florida and Wisconsin by 1987. Currently, it is the most important pest of honey bee colonies. The mites feed on the hemolymph of the developing bee larva, pupa, and adult bees. Dead or dying newly emerged bees have malformed wings, legs, abdomens, and thoraces. Recent anecdotal evidence suggests that bee viruses and varroa mites are closely linked. The mites have been shown to activate some of these viruses; causing virus outbreaks that ultimately lead to colony mortality.

Fluvalinate is currently registered for the control of varroa mites; however, populations of varroa mites have developed resistance to fluvalinate. Varroa mite resistance to fluvalinate has been well documented by the United States Department of Agriculture (USDA), Agricultural Research Service (ARS). According to USDA, ARS many hives treated with fluvalinate have resulted in wholesale colony losses. Due to the destructive nature of this pest coupled with the importance of honey bees (for honey production and pollination of numerous agricultural crops) to the U.S. economy, it is imperative that alternative means of controlling the varroa mite be developed.

The Agency has authorized the use of coumaphos in beehives to control varroa mites under section 18 of FIFRA since 1999 in up to 46 states. During the 2001 use season there were limited reports of mites resistant to coumaphos in Maine and Florida. Resistance to coumaphos in Florida was confirmed by the USDA's Texas Bee Lab in December of 2001. In Maine, bees are primarily imported during the growing season from Florida. South Carolina has indicated that the beekeeping industry is migratory in nature, especially in the coastal region of the state and subject to the introduction of coumaphos resistant mites from Florida. Therefore, the states have requested use of the unregistered product ApiLife VAR, containing thymol and eucalyptus oil to control mites resistant to coumaphos. EPA has authorized under FIFRA section 18 the use of thymol and eucalyptus oil in beehives for control of varroa mites in Maine, Minnesota, Mississippi, Utah, Indiana, and South Carolina. After having reviewed the submission, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of thymol and eucalyptus oil in or on honey and honeycomb. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary exemptions from the requirement of a tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these exemptions without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these exemptions from the requirement of a tolerance will expire and are revoked on June 30, 2005, under section 408(l)(5) of the FFDCA, residues of the pesticide in the tolerance remaining in or on honey and honeycomb after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA. EPA will take action to revoke these exemptions earlier if any experience with, scientific data on, or other relevant information on these pesticides indicate that the residues are not safe.

Because these exemptions from the requirement of a tolerance are being approved under emergency conditions, EPA has not made any decisions about whether thymol and eucalyptus oil meets EPA's registration requirements for use on honey and honeycomb or whether permanent exemptions for this use would be appropriate. Under these circumstances, EPA does not believe that these exemptions from the requirement of a tolerance serve as a basis for registrations of thymol and eucalyptus oil by a State for special local needs under FIFRA section 24(c). Nor do these exemptions serve as the basis for any State other than Maine and South Carolina to use these pesticides in beehives under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemptions for thymol and eucalyptus oil, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 thymol and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for exemptions from the requirement of a tolerance for residues of thymol in or on honey and honeycomb. EPA's assessment of the dietary exposures and risks associated with establishing these exemptions from the requirement of a tolerance follows.

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

The EPA has not received nor does it have available any guideline studies on the mammalian toxicity of thymol. Thymol is found naturally occurring in thyme herb (e.g., Thymus vulgaris, T. zygis ). Thyme herb is used as a food seasoning ingredient, and is generally recognized as a safe (GRAS) natural seasoning by the Food and Drug Administration (FDA) (21 CFR 182.10). Thyme oil also is recognized as a GRAS essential oil by FDA (21 CFR 182.20).

In September of 1993, the EPA issued a Reregistration Eligibility Decision (RED) for thymol. At that time the Agency concluded that thymol is an active ingredient that should be considered for a broad waiver of generic data requirements. This conclusion was based on the following information:

Thymol is a component of many non-pesticidal consumer products currently marketed in the United States. Thymol is listed as a food additive by the Food and Drug Administration (21 CFR 172.515; synthetic flavoring substances and adjuvants). Thymol is rapidly degraded in the environment to elemental constituents by normal biological, physical, and/or chemical processes that can be reasonably expected to exist where the pesticide is applied.... The phenols of thymol are considered GRAS as set forth in 21 CFR 172.515 (synthetic flavoring substances and adjuvants)....

Thymol toxicity data reported available literature cite acute oral LD 50 values as 980 milligrams/kilogram (mg/kg) and 880 mg/kg for the rat and guinea pig, respectively (Sax, 1984). The acute oral toxicity reported for the rat and guinea pig, respectively corresponds to Toxicity Category III. The Material Safety Data Sheet (MSDS) for the manufacture of technical grade thymol cites human health effects as irritating when exposed by inhalation, dermal or eye contact. The MSDS also estimates a human ingestion LD 50 at 2 grams of the synthetic thymol. Based upon an estimated thymol dermal toxicity LD 50 of greater than 2,000 mg/kg, the dermal toxicity would be Toxicity Category III. (Refer to pages 6 and 7 of the RED)

A summary of the submitted information on thymol toxicity allows for the statements that the acute oral LD 50 in the rat is 980 mg/kg and in the mouse is 640 to 1,800 mg/kg. Thymol is corrosive to the rabbit eye and skin, and is not reported as a dermal sensitizer in the guinea pig. Thymol is readily absorbed from the gastrointestinal tract and is essentially excreted in the urine as a glucuronate and sulfate conjugate of the parent compound. Dosing of rats with thymol in the feed at 667 mg/kg body weight/day (highest dose tested) for 19 weeks did not produce any harmful effects. Thymol is not mutagenic in Salmonella, but gives statistically significant positive results in an Unscheduled DNA synthesis and Sister Chromatid Exchange tests, and in a cell transformation test with Syrian hamster embryonic cells. Multiple malformations are noted when thymol is injected into the air bubble or yolk sac of embryonic chickens.

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

1. Dietary exposure —i. Food . Thymol is found naturally occurring in thyme herb (e.g., Thymus vulgaris, T. zygis ). Thyme herb is used as a food seasoning ingredient, and is generally recognized as a safe (GRAS) natural seasoning by FDA (21 CFR 182.10). Thyme oil also is recognized as a GRAS essential oil by FDA (21 CFR 182.20). The volatile oil component of thyme herb is about 2% to 5% content, and thyme oil is reported to contain from 30% to 75% thymol, and even up to 90%. Thymol may be safely used in foods as a synthetic flavoring substance when used in the minimum quantity to produce the intended effect (21 CFR 172.515). Levels of thymol reported in foods where it is permitted as a direct food additive have been stated as 44 ppm in ice cream, ices, etc.; 2.5 ppm to 11 ppm in non-alcoholic beverages; 9.4 ppm in candy, 5 ppm to 6.5 ppm in baked goods, and 100 ppm in chewing gum. Thymol is a natural component of lime blossom honey, where the maximum thymol content has been determined to be 0.16 mg/kg.

Studies in Europe showed that when ApiLife Var was used for 8 weeks in the autumn over 1 to 5 years the maximum thymol residue observed was 0.48 mg/kg. The average (median) residue value for thymol was 0.16 mg/kg in honey. When export and import tonnage values of honey are taken into consideration with U.S. honey production, the average yearly per capita intake of honey is about 2 pounds, roughly equivalent to 1 kg. If all the honey contained 0.5 mg/kg thymol then the per capita intake of thymol would be about 1.4 μg/day. For a 60 kg adult the chronic exposure value is about 0.022 μg/kg body weight/day. If a 60 kg adult consumed 1 kg of honey containing 0.5 mg thymol in 90 days the subchronic dietary exposure to thymol would be about 2 μg/kg body weight/day. Even if all 2 kg of the thymol-containing honey were consumed in one sitting, the acute exposure to thymol still would be as low as 83 μg.

2. Drinking water exposure . No drinking water exposure is expected from the pesticidal use of thymol which is confined to placement in beehives. Thymol is currently registered for use on ornamental plants, shrubs and grasses so there is some potential for exposure to water. However, thymol is a constituent of a mixture of organic compounds known to be rapidly degraded in the environment to elemental compounds by normal biological, physical and/or chemical processes. In the RED, the Agency concluded that the registered uses of thymol will result in negligible exposure of the environment and nontarget organisms (refer to page 7 of the RED). Therefore, thymol is not expected to be found in drinking water.

3. Other non-occupational exposure . The potential for non-dietary exposure to thymol residues for the general population, including infants and children, is unlikely because the proposed use site is limited to beehives. Thymol is a normal constituent of the human diet, as a component of thyme and thyme oil, and as a direct food additive. Therefore, while there exists a great likelihood of prior exposure for most, if not all individuals to thymol, any increased exposure due to the proposed use would be negligible. Thyme, which contains thymol, is a pesticide active ingredient for the control of aphids on ornamental plants. Thyme and thyme oil are considered minimum risk pesticides, and are exempted as active ingredients under FIFRA [40 CFR 152.25(g)].

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 thymol 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, thymol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this exemption from the requirement of a tolerance, therefore, EPA has not assumed that thymol 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).

The dietary exposure to residues of thymol to the U. S. population from use of ApiLife Var is not likely to add significantly to current dietary exposure to thymol. For instance, thymol has been measured in chewing gum at 100 mg/kg, in candy at 9.4 mg/kg, and in ice cream at 44 mg/kg. These values respectively are 200-, 20-, and 100-fold greater than the highest level of thymol (i.e., 0.48 mg/kg) measured in honey treated with ApiLife Var. In addition, thymol as measured in ice cream is about 300-fold higher than the average residue level of thymol (i.e., 0.16 mg/kg) in hives treated with ApiLife Var. Additionally, it is typical for language to appear on labels of honey that states “Do not feed to infants under 1 year,” so there likely would be no exposure of this population to residues of thymol in the honey. Older children likely have been exposed to thymol residues from consumption of candy, ice cream, and baked goods. Consumption of honey from hives treated with ApiLife Var is unlikely to significantly increase exposure to thymol. Therefore, based on the long history of use of thyme, thyme oil, and thymol in the diet with no known adverse effects, it is reasonable to conclude that no harm will result from exposure to thymol in honey from beehives treated with ApiLife Var. Accordingly, EPA finds that exempting thymol from the requirement of a tolerance will be safe.

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 eucalyptus oil and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for exemptions from the requirement of a tolerance for residues of eucalyptus oil in or on honey and honeycomb. EPA's assessment of the dietary exposures and risks associated with establishing these exemptions from the requirement of a tolerance follows.

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

The EPA has not received nor does it have available any guideline studies on the mammalian toxicity of eucalyptus oil. Eucalyptus oil is obtained from steam distillation of the leaves of Eucalyptus globulus and, in addition to cineole, contains triterpenes, monoterpenes, sesquiterpenes, aldehydes and ketones. Information submitted by the applicant allows for the statements that acute oral LD 50 value for eucalyptus oil in rats is 2,480 mg/kg. Eucalyptol (1,8-cineole) which makes up 70% or more of eucalyptus oil may be safely used in foods as a synthetic flavoring substance when used in the minimum quantity to produce the intended effect (21 CFR 172.515). Eucalyptus globulus leaves also may safely be used in foods (21 CFR 172.510).

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

1. Dietary exposure. —i. Food. Eucalyptus oil is obtained from steam distillation of the leaves of Eucalyptus globulus and, in addition to cineole, contains triterpenes, monoterpenes, sesquiterpenes, aldehydes and ketones. Levels of eucalyptus oil reported in foods where it is permitted as a direct food additive have been stated as 0.5 to 50 ppm in ice cream, ices etc.; 1.7 ppm in non-alcoholic beverages; 1.0 ppm in alcoholic beverages; 130 ppm in candy; and 76 ppm in baked goods. Cineole in foods has been reported at 0.13 ppm in non-alcoholic beverages; 0.50 ppm in ice cream, ices, etc.; 15 ppm in candy; 0.5 to 4.0 ppm in baked goods, and 190 ppm in chewing gum.

Studies in Europe showed that when ApiLife Var was used for 8 weeks in the autumn over 1 to 5 years, residues of eucalyptus oil (measured as 1,8-cineole) were less than the limit of detection, i.e., < 0.01 ppm.

ii. Drinking water exposure . No drinking water exposure is expected from the pesticidal use of eucalyptus oil which is confined to placement in beehives. Further, there are no products registered that will result in exposure to drinking water. Therefore, eucalyptus oil is not expected to found in drinking water.

2. Other non-occupational exposure. The potential for non-dietary exposure to eucalyptus oil residues for the general population, including infants and children, is unlikely because the proposed use-site is limited to beehives. Eucalyptus oil is a constituent of the human diet as a direct food additive. Eucalyptus oil is used as a component of decongestant products, as an expectorant component of cough and cold products, in various oral dosage forms (e.g., lozenges and syrups), and as an inhalant in vapor baths. It is used in dermally applied products for burns, blisters, and for muscle and joint aches. It may be a component of toothpaste, soaps, detergents and toiletries. It is reported to be used internally at 0.3 to 0.6 grams/day, and externally at 5% to 20% in paraffin, jelly, or vegetable oil bases. Oil of eucalyptus has antimicrobial properties, and has been registered as an active pesticide ingredient in an herbal flea collar pet product (active ingredient is in the product at 1.00%).

3. 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 eucalyptus oil 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, eucalyptus oil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this exemption from the requirement of a tolerance, therefore, EPA has not assumed that eucalyptus oil 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).

The dietary exposure to residues of eucalyptus oil to the U.S. population from use of ApiLife Var is not likely to add significantly to current dietary exposure to eucalyptus oil. This is because no residues of eucalyptus oil were detectable (i.e., < 0.01 ppm; measured as 1,8-cineole) when ApiLife was used in hives in the autumn in Europe for up to 5 years. Even if oil of eucalyptus residues were found in honey from hives treated with Apilife Var, they would have to be present at 5,000 times greater than the limit of detection to reach the level reported in ice cream (i.e., 50 mg/kg) and 170 times greater than the limit of detection to reach the level reported in non-alcoholic beverages (i.e., 1.7 mg/kg). Therefore, based on the long history of use of eucalyptus oil in the diet with no known adverse effect, coupled with the expectation of no to minimal residues from use of ApiLife Var in hives, it is reasonable to conclude that no harm will result from this pesticidal use. Accordingly, EPA finds that exempting eucalyptus oil from the requirement of a tolerance will be safe.

The Agency has not reviewed the method, nor its accuracy or reliability, used to previously analyze thymol and eucalyptus oil residues in honey; nor has it confirmed that prior use of ApiLife Var in European hives will give equivalent residues in hives in the United States. However, review of information submitted on a gas chromatographic method of analysis to measure thymol and eucalyptus oil in European hives, and the similarity of the European hives to U.S. hives allow for the conclusion that thymol and eucalyptus oil residues in honey from these hives will not be significantly greater, provided ApiLife Var is applied at the same rates to overwintering hives in the United States as was done previously in Europe.

The method may be requested from: Barbara Madden, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:(703) 305-6463; e-mail address: madden.barbara@epa.gov.

No Codex Maximum Residue Levels (MRL) are established for thymol. However, Switzerland has established an MRL of 0.8 mg/kg, apparently not from a safety finding, but rather arising from legislation that prohibits foreign odors or tastes in honey. According to the World Health Organization, thymol residues in food are safe to consumers at up to 50 mg/kg. According to European Union regulation Nr. 2377/90, thymol is in group II of the non-toxic veterinary drugs which do not require a MRL. No Codex Maximum Residue Levels (MRL) are established for eucalyptus oil.

Therefore, time-limited exemptions from the requirement of a tolerance are established for residues of thymol and eucalyptus oil in or on honey and honeycomb.

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-2003-0002 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 5, 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 VII.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 the docket ID number OPP-2003-0002, 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).

This final rule establishes a time-limited exemption from the tolerance requirement under section 408 of the FFDCA. 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 FIFRA section 18 exemption under section 408 of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. 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).

In Title 50 of the Code of Federal Regulations, Part 600 to End, revised as of October 1, 2002, § 648.21 is corrected by removing paragraph (e) appearing on page 337 and reinstating the paragraph (e) appearing on page 316 in the 2000 edition. The reinstated text reads as follows: