The FAA has determined that good cause exists for making these special conditions effective upon issuance; however, interested persons are invited to submit such written data, views, or arguments as they may desire. Communications should identify the docket number and special conditions number, and be submitted in duplicate to the address specified above, or, if you have access to the internet, you may make a submission to the following Internet address: “chung.hsieh@faa.gov”. All communications received on or before the closing date for comments will be considered by the Administrator. These special conditions may be changed in light of the comments received. All comments submitted will be available in the docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Persons wishing the FAA to acknowledge receipt of their comments submitted in response to this request must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. NE122.” The postcard will be date-stamped and returned to the commenter.

On August 12, 1996, GEAE applied for an amendment to Type Certificate No. E8NE to include new models CT7-6 and CT7-8 turboshaft engines. These models, derivatives of the CT7-6 series turboshaft engine, will include new rated 30-second and 2-minute one-engine-inoperative (OEI) power. On March 10, 2000, GEAE requested an additional rated 30-minute power for models CT7-6E and CT7-8 turboshaft engines. This rating is intended for use after takeoff, for up to 30 minutes at any time between takeoff and landing during any flight when performing search and rescue missions. These engine models will be rated at 30-second OEI, 2-minute OEI, 30-minute OEI, 30-minute, takeoff, and maximum continuous ratings. The existing requirements do not contain a definition for a rated 30-minute power, and do not contain adequate or appropriate safety standards of this new and unusual engine rating.

The rated 30-minute power is the approved brake horsepower developed under static conditions at specified altitudes and temperatures within the operating limitations established under 14 CFR part 33 for periods of use no longer than 30 minutes each. This rating power would provide for rotorcraft hovering operations at a power level greater than maximum continuous power. The certification requirements have been defined around the worst case scenario of unrestricted periods of use up to 30 minutes each in one flight. Therefore, the total accumulated time for endurance testing of 30-minute periods at rated 30-minute power must be 25 hours for certification. However, because the CT7-6E and -8 engine models have a rated 30-minute OEI at higher power and engine limitations than rated 30-minute power, the test run time of 12.5 hours under 33.87(c) may be credited to satisfy one half of the required running time for rated 30-minute power. The additional endurance test runs required for these engine models would therefore be 25 periods of test at rated 30-minute power for 30 minutes each.

Under 14 CFR 21.101, GEAE must show that the models CT7-6E and CT7-8 turboshaft engines meet the requirements of the applicable regulations in effect on the date of the application, or the applicable provisions of the regulations incorporated by reference in Type Certificate No. E8NE. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis”. Since models CT7-6E and CT7-8 engines are derivatives of the model CT7-6 series turboshaft engine, the regulations incorporated by reference of the engine in Type Certificate No. E8NE are part 33, effective February 1, 1965, as amended by Amendments 33-1 through 33-5; § 33.87, Amendment 12; and Special Conditions Number 33-76-NE-2, Docket No. 16921 (issued October 31, 1978). However, GEAE has elected to demonstrate compliance of later amendments of part 33 for the engines. The certification basis for models CT7-6E and CT7-8 turboshaft engines will be part 33, effective February 1, 1965, as amended by Amendments 33-1 through 33-19; and Special Conditions No. 33-002-SC, Docket No. NE121, published on May 28, 1999 (64 FR 28900).

The Administrator finds that the applicable airworthiness regulations in part 33, as amended, do not contain adequate or appropriate safety standards for the new rated 30-minute power for engine models CT7-6E and CT7-8 turboshaft engines. Because it is a novel or unusual engine rating feature, special conditions are prescribed under the provisions of 14 CFR 21.16.

Special conditions, as appropriate, are issued in accordance with 14 CFR 11.49 after public notice, as required by §§ 11.28 and 11.29(b), and became part of the type certification basis in accordance with 14 CFR 21.101(b)(2).

The GEAE engine models CT7-6E and CT7-8 turboshaft engines will incorporate the following novel or unusual design feature: Rated 30-minute power. The power available for rotocrafts hovering to perform search and rescue missions is limited to the maximum continuous rating power under the current part 33 requirements. The proposed rated 30-minute power would provide a higher power level than currently available for use up to 30 minutes at any time between takeoff and landing during any flight. This new rating will enhance rotorcraft safety through the availability of increased power for hovering operations calling for greater than maximum continuous power.

As discussed above, these special conditions are applicable to the GEAE models CT7-6E and CT7-8 turboshaft engines. Should GEAE apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of 14 CFR 21.101(a)(1).

This action affects only certain novel or unusual design features on GEAE models CT7-6E and CT7-8 turboshaft engines. It is not a rule of general applicability, and it affects only the applicant who applied to the FAA for approval of these features on the engines.

The authority citations for these special conditions is as follows:

On May 25, 2000, the FAA published a final rule that established a Class E airspace extension at the Centennial Airport, Englewood, CO (65 FR 33750). However, that action erroneously described the airspace as E5 instead of E4. Also, in the legal description text, the word “radius” was inappropriately applied. This action corrects the final rule by reflecting the proper airspace designation and description.

On May 25, 2000, the FAA proposed to amend Title 14, Code of Federal Regulations, part 71 (14 CFR part 71) by modifying Class E airspace at Wenatchee, WA, to remove the Fancher Field airspace exclusion in the legal description for the Panghorn Memorial Airport, Wenatchee, WA (65 FR 33796). Fancher Field has been abandoned negating the requirement for its Class E2 airspace exclusion. This airspace modification would delete the airspace requirement for Fancher Field and correct the legal description for Wenatchee, WA. Interested parties were invited to participate in the rulemaking proceeding by submitting written comments on the proposal. No comments were received.

This amendment to Title 14 Code of Federal Regulations, part 71 (14 CFR part 71) modifies Class E airspace at Wenatchee, WA, by removing the Fancher Field airspace exclusion in the legal description for the Panghorn Memorial Airport, Wenatchee, WA. Fancher Field has been abandoned negating the requirement for its Class E2 airspace exclusion. This airspace modification deletes the airspace requirement for Fancher Field and corrects the legal description for Wenatchee, WA. The FAA establishes Class E airspace where necessary to contain aircraft transitioning between the terminal and en route environments. This rule is designed to provide for the safe and efficient use of the navigable airspace and promote safe flight operations at the Wenatchee Airport.

The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. Class E airspace areas designated as surface areas, are published in Paragraph 6002, of FAA Order 7400.9G dated September 1, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.

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

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

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

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. The SIAP's contained in this amendment are based on the criteria contained in the United States Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports.

The FAA has determined through testing that current non-localizer type, non-precision instrument approaches developed using the TERPS criteria can be flown by aircraft equipped with a Global Positioning System (GPS) and or Flight Management System (FMS) equipment. In consideration of the above, the applicable SIAP's will be altered to include “or GPS or FMS” in the title without otherwise reviewing or modifying the procedure. (Once a stand alone GPS or FMS procedure is developed, the procedure title will be altered to remove “or GPS or FMS” from these non-localizer, non-precision instrument approach procedure titles.)

The FAA has determined through extensive analysis that current SIAP's intended for use by Area Navigation (RNAV) equipped aircraft can be flown by aircraft utilizing various other types of navigational equipment. In consideration of the above, those SIAP's currently designated as “RNAV” will be redesignated as “VOR/DME RNAV” without otherwise reviewing or modifying the SIAP's.

Because of the close and immediate relationship between these SIAP's and safety in air commerce, I find that notice and public procedure before adopting these SIAP's are, impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

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

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

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

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

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

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

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

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

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

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

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

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

This guidance outlines Federal agencies' responsibility for evaluating the efficacy and efficiency of their conformity assessment activities. Each agency is responsible for coordinating its conformity assessment activities with those of other appropriate government agencies and with those of the private sector to make more productive use of the increasingly limited Federal resources available for the conduct of conformity assessment activities and to reduce unnecessary duplication.

This guidance applies to all agencies, which set policy for, manage, operate, or use conformity assessment activities and results, both domestic and international, except for activities carried out pursuant to treaties. “Agency” means any Executive Branch Department, independent commission, board, bureau, office, agency, government-owned or controlled corporation, or other establishment of the Federal government. It also includes any regulatory commission or board, except for independent regulatory commissions subject to separate statutory requirements regarding policy setting, management, operation, and use of conformity assessment activities. It does not include the legislative or judicial branches of the Federal government.

In February 1996, The National Technology Transfer and Advancement Act (NTAA) of 1995 was enacted by Congress. Section 12 of the Act directed NIST to coordinate conformity assessment activities of Federal, state and local entities with private sector technical standards activities and conformity assessment activities with the goal of eliminating any unnecessary duplication of conformity assessment activities. The Office of Management and Budget (OMB) Circular A-119, revised February 19, 1998 directed the Secretary of Commerce to issue guidance to the agencies to ensure effective coordination of Federal conformity assessment activities. The Director of the National Institute of Standards and Technology (NIST), United States Department of Commerce, published proposed guidance in the Federal Register on Federal conformity assessment activities on November 3, 1999 (64 FR 59691 (1999)). Closing date for comments was January 18, 2000.

NIST received comments from nine commentors, including: one national standards coordinating and conformity assessment accreditation body, one government agency, one international company, one laboratory accreditation body, one certification body, one consulting organization, and three trade associations in response to its request. In addition, in September 1999, the U.S. General Accounting Office (GAO) published a report, entitled “GAO/GGD-99-170—Certification Requirements: New Guidance Should Encourage Transparency in Agency Decisionmaking,” which contained a recommendation for including a section in the guidance on the issue of transparency in agency certification decisionmaking. The 51 comments as well as the GAO recommendation were considered in finalizing the guidance. The following summarizes the comments received and the agency's response to the comments.

One national standards coordinating and conformity assessment accreditation body commented that the guidance should task only NIST with substantive objectives and identify the approach and procedures for accomplishing them.

Response: In OMB Circular A-119, OMB stated that “(t)o ensure effective coordination, the Secretary of Commerce must issue guidance to the agencies.” This guidance is a response to that mandate. The suggested approach would not be consistent with OMB's mandate.

One laboratory accreditation body commented the proposed rule should be withdrawn and that the guidance be issued as an annex to OMB Circular A-119.

Response: This document is intended to serve as guidance for Federal agencies in implementing their responsibilities under the NTTAA, and is not a rule. The guidance was issued at the direction of OMB, which chose not to include conformity assessment in OMB Circular A-119. This comment has been forwarded to OMB for consideration during the next revision of the Circular.

One government agency commented that while the examples in the guidance were helpful in describing how the guidance may be implemented, they should remain examples in the final version of the guidance.

Response: NIST agrees with this comment.

One government agency commented that Federal regulatory programs that engage in conformity assessment must apply a high degree of scrutiny to ensure that requirements are met. Therefore, it may be very difficult to rely on the work of private sector organizations, which understandably perform their activities for other motives and perhaps to a lesser degree of scrutiny. The guidance should present the option that private sector organizations rely on the conformity assessment activities of a Federal agency. This option would also promote the objectives under the proposed Section 287.1.

Response: Elimination of unnecessary duplication and complexity in conformity assessment activities can be accomplished by relying on private sector conformity assessment programs and activities. However, reduction in duplication and complexity can also be accomplished by Federal agency reliance on other governmental conformity assessment activities, by reliance on supplier's declaration of conformity, or by encouraging the private sector to rely on governmental activities. The NTTAA does not indicate a preference for any specific approach. The determination of which approach best meets agency objectives is the responsibility of the agency.

One national standards coordinating and conformity assessment accreditation body commented that Section 287.1 should provide more information on the evaluation procedures to be used to evaluate the efficacy and efficiency of Federal conformity assessment activities.

Response: The variety of conformity assessment activities conducted by different Federal agencies precludes development of specific evaluation techniques that would apply to all agencies. Guidance on how to measure certain aspects of performance (regulatory burden, cost-benefit issues, etc.,) is available from the Office of Management and Budget (OMB) and from other sources within the Federal government, but this guidance must usually be tailored to reflect the type of activities a given agency undertakes. NIST believes that evaluations of only one aspect of program performance can be misleading. Evaluations of program performance/effectiveness should consider all programmatic aspects, including an agency's legislative mandates, program objectives and resource availability.

One laboratory accreditation body commented that the second and third sentences of Section 287.1 should be replaced by: “Each agency should seek ways in which it can use existing conformity assessment activities of the private sector instead of creating or maintaining their own activities.”

Response: The purpose and scope, as currently written in Section 287.1, best reflects the intent stated in the Act, which is to eliminate “unnecessary duplication and complexity in the development and promulgation of conformity assessment requirements and measures.” This can be accomplished in a number of ways. Using the results of private sector conformity assessment activities is only one method.

One laboratory accreditation body commented that the last sentence of Section 287.1 should be revised to cite the role of the U.S. Trade Representative (USTR) in overseeing the implementation of the U.S. trade obligations including commitments under the World Trade Organization (WTO) Agreement on Technical Barriers to Trade (TBT).

Response: The guidance is not intended to address U.S. obligations or the USTR's role in implementing the WTO Agreement or in other trade agreements. This guidance addresses only matters covered in the NTTAA. The Federal government's obligations under the World Trade Organization Agreement and other trade agreements are addressed elsewhere.

One consulting organization commented that NIST should state its position on who is responsible for accreditation in the United States.

Response: Accreditation activities can be conducted by either the public and/or the private sector. The appropriate sector to be assigned responsibility for accreditation should be determined on a case-by-case basis. The need for accreditation also needs to be determined on a case-by-case basis. There is no one-size-fits-all solution to this issue.

One certification body commented that the Interagency Committee on Standards Policy (ICSP) should be opened to regular participation and attendance by private sector standards developers and organizations providing conformity assessment services to facilitate cooperation and confidence between the government and private sector conformity assessment organizations.

Response: The ICSP has invited a number of standards developers and conformity assessment organizations to present information and viewpoints on topics of interest to the ICSP. However, the ICSP is an interagency committee. Membership is restricted to the Federal departments and agencies listed in its charter.

One certification body commented that the promotion of accreditation and/or recognition organizations that have not demonstrated added value to the marketplace should be discouraged.

Response: NIST agrees with this comment. Agencies are responsible for meeting programmatic objectives in a cost-effective manner. However, it is the responsibility of each agency to determine which approach best meets its needs.

One certification body commented that no single mechanism can meet the needs of all suppliers or acceptance authorities around the globe. New mechanisms that facilitate trade, provide regulatory confidence and protect public safety should be considered as they are developed and proven effective to meet the needs of supplier and acceptance authorities.

Response: NIST agrees with this comment. However, it remains the responsibility of each agency to determine which mechanisms are appropriate for application within its programs.

One trade association commented that the following objectives should be included in the proposed guidance:

• Eliminate the cost to government of conducting (developing) its own conformity assessment activities and thereby decrease the cost of goods procured and the burden of complying with agency regulation;

• Provide incentives and opportunities (to whom) to establish conformity assessment programs that serve national needs;

• Encourage long term growth of U.S. enterprises and promote efficiency and economic competition through harmonization of conformity assessment activities; and

• Further the policy of reliance upon the private sector to supply the government need for goods and services.

Response: While the statements listed above are a partial list of potential benefits from implementation of the guidance, the objective of the guidance was clearly and succinctly defined in the NTAAA—to eliminate “unnecessary duplication and complexity in the development and promulgation of conformity assessment requirements and measures.”

One national standards coordinating and conformity assessment accreditation body commented that the definition of recognition is too narrow in section 287.2 and is inconsistent with the way it is used in the example in section 287.4.

Response: While the definition for the term “recognition” in Section 287.2 is appropriate; the term has been changed in the example.

One national standards coordinating and conformity assessment accreditation body and one trade association commented that the definitions in the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) Guide 2 should be cited without modification.

Response: The definitions in section 287.2 were based on ISO/IEC Guide 2, but the definitions have been modified to better address the nature of Federal government conformity assessment activities. Definitions were considered necessary because agencies do not use consistent terminology in their regulatory and procurement conformity assessment programs. This inconsistent use of terminology could create potential confusion for agencies reading the guidance. NIST decided to define only those terms which were considered to be necessary to understand the guidance.

One laboratory accreditation body commented that the World Trade Organization (WTO) Agreement on Technical Barriers to Trade (TBT) definition of conformity assessment should be referenced and “mandatory administrative procedures” should not be excluded from the definition.

Response: ISO/IEC Guide definitions have been used in accordance with the NTTAA's requirements that preference be given to the use of voluntary consensus standards. There is also no evidence in the Act or legislative history that Congress intended to include mandatory administrative procedures.

The Occupational Safety and Health Administration (OSHA) commented that some of the key definitions in the notice do not correctly depict the Occupational Safety and Health Administration's (OSHA's) National Recognized Testing Laboratory (NRTL) Program. OSHA recognizes a testing/certification body under the NRTL Program, not an accreditation body. In addition, the agency commented that OSHA's recognition does not mean that an organization is “competent” in testing or in certification to the extent that “competent” means adept, proficient or a similar term. To obtain recognition, an organization must demonstrate that it meets the requirements in 29 CFR 1910.7, but this regulation does not include requirements for proficiency or other criteria to judge “competence.”

Response: NIST agrees that agencies do not use standardized terminology in their conformity assessment activities. In defining key terms, NIST intended to let the reader know what is meant by that term within the context of the guidance. NIST recognizes that the same term may be used by different agencies to mean very different types of activities. A footnote will be added to the definition for “accreditation” to accommodate OSHA's activities.

OSHA also commented that the definition of conformity assessment describes requirements as being applicable to “products, services, and systems,” but not to “organizations” and requested that the word “organizations” be added.

Response: The word “organizations” has been added.

One international company, one laboratory accreditation body, and one trade association commented that the guidance should identify supplier's declaration as an appropriate option for agencies to consider in their conformity assessment policies, taking into account the appropriate balance of risks and benefits of first party (supplier), second party, and third party conformity assessment for specific products and services. The same trade association recommended that NIST amend the definition in the proposed Section 287.2 as follows: In the definition of conformity assessment, add “suppliers declaration of conformity” after “inspection” and add a definition for “supplier's declaration of conformity.”

Response: The guidance now includes reference to first, second and third party conformity assessment activities and procedures. The definition of conformity assessment has been amended to include “supplier's declaration of conformity.” A definition of “supplier's declaration of conformity” has also been included. However, the guidance does not intend to suggest that any one method or activity is preferable. It is the responsibility of each agency to select the conformity assessment activities and procedures, which will best meet its legislative mandates and programmatic objectives in the most cost-effective and efficient manner.

One national standards coordinating and conformity assessment accreditation body commented that NIST should be charged in section 287.3 with ensuring that other agencies are aware of their obligation to adopt policies needed to accomplish the purpose of this guidance.

Response: While NIST is charged with coordinating conformity assessment activities, agencies remain responsible for their own conformity assessment activities, including the adoption of any policies that agencies feel are needed to operate in accordance with their statutory mandates. NIST is available and willing to assist agencies in carrying out this responsibility and to provide guidance as needed.

One national standards coordinating and conformity assessment accreditation body and one trade association commented that some attention should be given in section 287.3 to NIST's obligations beyond the Federal level, especially to its obligations at the state level.

Response: NIST partially agrees with this comment. The language in the Act is unclear as to what Congress intended NIST to do with regard to state conformity assessment activities. However, in the Congressional House Record of 2/27/96 for The National Technology Transfer and Advancement Act (NTTAA), Representative Morella stated that: “Section 12 Standards Conformity. Restates existing authorities for the National Institute of Standards and Technology (NIST) activities in standards and conformity assessment. Requires NIST to coordinate among Federal agencies, survey existing state and Federal practices, and report back to Congress on recommendations for improvements in these activities.” NIST is undertaking studies of existing state conformity assessment practices, subject to resource limitations. NIST also plans to undertake additional activities with the states as resources become available. Any activities undertaken by NIST will be conducted in a manner that respects state sovereignty issues. NIST has added the following statement to the guidance: “To the extent that resources are available, NIST will develop information on existing state conformity assessment practices; and, upon request by a state government agency, will work with that agency to reduce duplication and complexity in state conformity assessment activities.”

One laboratory accreditation body commented that a new clause should be added to section 287.3 so that NIST would also “encourage government participation and use of private sector, conformity assessment activities to the maximum extent practical.”

Response: NIST disagrees. NIST is obligated to assist other Federal agencies in reducing duplication and complexity in their conformity assessment activities. The use of private sector conformity assessment activities is only one of a number of methods that can be used by an agency to accomplish this goal. It remains the responsibility of the agency to determine which method is most appropriate for its specific applications.

One national standards coordinating and conformity assessment accreditation body commented that the example in section 287.4, which uses the term “recognition,” does not support the use of the qualifier “mutual.”

Response: The agency agrees with this comment. The qualifier “mutual” has been removed and the term “recognition” has been replaced.

One national standards coordinating and conformity assessment accreditation body and one laboratory accreditation body commented that a list of references, containing the documents of the organizations cited in section 287.4 should be inserted in this section or that NIST should provide a list of specific conformity assessment guides and standards, perhaps as a separate document.

Response: NIST believes that a better solution is to address an agency's need for a list of applicable standards on a case-by-case basis. NIST's National Center for Standards and Certification Information (NCSCI) assists agencies to identify possible conformity assessment standards/guides, which may be of interest for a specific application. The organizations listed in the guidance are examples, and are not intended to represent a comprehensive list of organizations that develop standards and guidance in the conformity assessment area. A specific list could omit standards of potential interest to agencies in conformity assessment related areas or from other organizations not included as examples. In addition, such a list would rapidly become outdated as ISO guides and standards in the conformity assessment area are revised, reissued, or removed. Lastly, standards that appear on such a list might be presumed by some to have a “special blessing” by NIST, which could create misunderstanding. Agencies can contact NCSCI for a list of standards in their area of interest.

One national standards coordinating and conformity assessment accreditation body commented that section 287.4 should be rewritten to address the policies and procedures that should be adopted by agencies through the mechanism of the Interagency Committee on Standards Policy (ICSP). The development of a policy on conformity assessment might be stipulated that would address the roles of supplier's declaration, third parties, and accreditors.

Response: As noted in section 287.3(a), NIST will assist “the ICSP in developing policies and guidance on conformity assessment issues.” Agency Standards Executives serving on the ICSP are responsible for determining which policies and procedures the ICSP should develop, which might be useful for consideration within their agencies. However, the individual agency is responsible for the final selection and implementation of the policies and procedures needed by the agency to implement the goals of the NTTAA.

One national standards coordinating and conformity assessment accreditation body commented that the ICSP Agency Standards Executives' suitability for serving as change agents with respect to the conformity assessment activities of the Federal government should be reconsidered.

Response: The selection of the ICSP Agency Standards Executives is the responsibility of the Agency, as noted in section 287.4(n). The agency is responsible for selecting an individual who is capable of carrying out the guidance in OMB Circular A-119 as well as the guidance in this document. If needed, the Agency is free to assign additional personnel to assist the Agency Standards Executive in carrying out these responsibilities.

One international company commented that the examples listed in section 287.4(g) are limited to laboratory issues and organizations that are close to the Federal process. It would be appropriate to list some other organizations such as the American National Standards Institute (ANSI) or the International Organization for Standardization's (ISO) Committee on Conformity Assessment (CASCO) to indicate the broader direction that is intended.

Response: The examples cited have been included in the guidance.

One international company commented that organizations, such as the American National Standards Institute (ANSI) or the International Organization for Standardization's (ISO) Committee on Conformity Assessment (CASCO) be listed in section 287.4(j) to indicate the broader direction that is intended.

Response: Section 287.4(j) does not list examples. Participation in the development of any private sector conformity assessment standards (consistent with the mission and objectives of the agency) would be included in this section. ANSI does not develop standards, so it would not be included in this section. ISO is a private sector organization, which develops conformity assessment standards, so participation in ISO CASCO is included in this section.

One laboratory accreditation body commented that in section 287.4(c), agencies need to consider ways to use not only conformity assessment results of others (both domestic and foreign), but the conformity assessment activities themselves as a replacement for their own activities.

Response: This comment addresses matters beyond the scope of this guidance. Regulatory and procurement obligations of Federal agencies have been authorized by Congress, and such activities/systems cannot be replaced by private sector activities/systems without congressional approval or legislative change.

One laboratory accreditation body commented that the examples in sections 287.4(e) and (h) are weak as they only suggest an agency might supplement (not replace) its own activities with outside conformity assessment activities mainly administered by other government agencies.

Response: In section 287.4(e), NIST will include the example of the Federal Communications Commission's FCC Telecommunications Certification Body (TCB) program, which allows designated private entities to issue telecommunications equipment approvals for specified regulatory requirements in essentially the same manner as the FCC. FCC has also replaced requirements for premarketing approval with supplier's declaration of conformity for certain types of equipment.

One laboratory accreditation body commented that in section 287.4(f), it is not clear why “mutual recognition” is necessary or desirable between agencies when one-way recognition may also be appropriate.

Response: This section has been reworded.

One laboratory accreditation body commented that section 287.4(g) should delete any reference to the National Environmental Laboratory Accreditation Conference (NELAC) because NELAC specifically prohibits private sector laboratory accreditation bodies from being part of NELAC by suggesting that accreditation is an inherent government function. This is contrary to the intent of the NTTAA, which encourages use of private sector conformity assessment activities.

Response: The purpose of the NTTAA is to eliminate unnecessary duplication and complexity in conformity assessment activities. While this can be done by relying on private sector conformity assessment programs and activities, it can also be accomplished by relying on other governmental activities, by relying on a supplier's declaration of conformity, or by encouraging the private sector to rely on governmental activities. While agencies should consider alternative approaches in their rulemaking and procurement activities, the determination of which approach best meets agency objectives is the responsibility of the agency.

One laboratory accreditation body and one trade association commented that sections 287.4(i) should cite the USTR's role in trade policy. The same trade association commented that sections 287.4(j) should also cite the USTR's role.

Response: While NIST recognizes the important role that the USTR has in developing trade related policies, as well as the responsibilities placed on Federal agencies as a result of trade agreements, such as the WTO Agreement, these roles and responsibilities are defined in other legislation and related documents. This guidance addresses only matters covered in the NTTAA.

One laboratory accreditation body commented that there is no need for separate government recognition systems if equivalent systems exist in the private sector that provide equivalent recognition. Government recognition systems would add cost without adding value and would create unnecessary duplication and complexity, the opposite intent of the NTTAA.

Response: In trade agreements, the need for government recognition of conformity assessment bodies is determined not only by the U.S. Government, but also by the other countries signatory to such an agreement. Since some governments do not deem the use of private sector systems to be adequate proof of competence in the absence of governmental recognition, such recognition becomes a requirement under the terms of the specific agreement. For domestic regulatory and procurement issues, it is the responsibility of each Federal agency to determine whether use of a private sector system can adequately address all of its programmatic objectives and any relevant legislative mandates in a cost-effective manner.

One trade association commented that while the reference to the National Cooperation for Laboratory Accreditation (NACLA) and the National Environmental Laboratory Accreditation Conference (NELAC) in section 287.4(g) begins to address the issue of duplication of accreditations for testing programs, the proposed guidance should also provide direction related to other forms of conformity assessment, such as certification and registration.

Response: The organizations listed in section 287.4(g) are intended to serve only as examples of activities in which agencies should consider participation. The activities of ANSI have been added to the list of examples to better illustrate the broad range of activities where Federal participation is encouraged.

One trade association commented that the wording in section 287.4(c) should strongly encourage the use of private sector conformity assessment programs in lieu of the development of government programs. The same trade association commented that Section 287.4(e) include a requirement that NIST provide a centralized coordinating function in the determination of acceptable private sector conformity assessment practices. To allocate the responsibility to each agency only continues the duplication of accreditation and approval processes. NIST should advocate the use of private sector accreditation bodies that comply with national and international criteria as the tool to be used for determination of acceptance. The same trade association also commented that in section 287.4(f), mutual recognition of private sector procedures should be recommended for all agencies.

Response: The purpose of the NTTAA is to eliminate unnecessary duplication and complexity in conformity assessment activities. While this can be done by relying on private sector conformity assessment programs and activities, it can also be accomplished by relying on other governmental activities, by relying on a supplier's declaration of conformity, or by encouraging the private sector to rely on governmental activities. While agencies should consider alternative approaches in their rulemaking and procurement activities, the determination of which approach best meets agency objectives is the responsibility of the agency.

One trade association commented that in section 287.4(j), agencies should be encouraged to participate in the development of private sector conformity assessment procedures and programs as well as the development of standards. RESPONSE: NIST partially agrees with this comment. The responsibility for participation in conformity assessment programs and activities, as distinct from standards development, is covered in section 287.4(g). The examples in this section will be expanded to include participation in ANSI's conformity assessment related activities to better illustrate the intention of this section.

GAO Recommendation: GAO recommended that the guidance include a section that “specifically addresses the transparency of agencies' certification decisionmaking.” GAO recommended that the guidance “should encourage agencies to publicly explain why particular certification decisions were made or how certification decisions in the future will be made.”

Response: A new item has been added to section 287.4 of the guidance to address this issue.

One national standards coordinating and conformity assessment accreditation body commented that section 287.5 places responsibility for both standards and conformity assessment with one representative from each agency and noted that a significant majority of persons with major responsibilities for standards have no responsibility or knowledge of conformity assessment.

Response: NIST partially disagrees with this comment. The Office of Management and Budget (OMB) A-119 indicates that more than one Standards Executive was not contemplated by OMB. That is, the Circular speaks of “a” Standards Executive (14(c)) and “the” Standards Executive (14(d)), etc. NIST and OMB believe that having only one Standards Executive would facilitate better coordination and communication for both standards and their related conformity assessment activities. However, both also recognize that because responsibility for an agency's conformity assessment activities may cut across organizational boundaries, it may be necessary to assign additional agency personnel to carry out these new responsibilities. The agency must ensure that these responsibilities are coordinated and should carefully define each staff member's responsibilities to ensure that the duties defined under this guidance and under OMB Circular A-119 are effectively carried out.

One laboratory accreditation body commented that section 287.5 should contain reporting requirements for the annual agency reports to NIST and OMB, including whether each agency gave consideration to the use of relevant private sector, conformity assessment activities and the reason for not using them—similar to agencies' reporting under OMB Circular A-119. NIST itself should be required to make similar reports justifying it own conformity assessment activities.

Response: Mandatory agency reporting requirements regarding conformity assessment activities were not specified in the NTTAA. Conformity assessment reporting requirements for all agencies, including NIST, remain voluntary.

One government agency commented that the guidance states that each agency “should coordinate its * * * activities” to make “more productive use of * * * limited Federal resources * * *.” However, the “responsibilities” under the proposed Section 2987.5 and the actual coordination could demand resources that may more than offset any gains expected from the coordination.

Response: The guidance does not recommend that agencies undertake activities where the costs involved are likely to exceed the benefits realized. While coordination is often beneficial and should always be considered, the agencies themselves are responsible for the final decision as to the appropriate level of coordination and commitment of resources to the agency's conformity assessment activities.

One trade association commented that a new responsibility should be added to this section— “To use private sector conformity assessment program results in all agency assessment programs.”

Response: The goal of the guidance, which is spelled out in the NTTAA, can be accomplished in a number of ways. It is the responsibility of each agency to determine which option or set of procedures is most appropriate for its application.

This guidance outlines Federal agencies' responsibility for evaluation the efficacy and efficiency of their conformity assessment activities. Each agency is responsible for coordinating its conformity assessment activities with those of other appropriate government agencies and with those of private sector to make more productive use of the increasingly limited Federal resources available for the conduct of conformity assessment activities and to reduce unnecessary duplication.

This guidance applies to all agencies, which set policy for, manage, operate, or use conformity assessment activities and results, both domestic and international, except for activities carried out pursuant to treaties. “Agency” means any Executive Branch Department, independent commission, board, bureau, office, agency, government-owned or controlled corporation, or other establishment of the Federal government. It also includes any regulatory commission or board, except for independent regulatory commissions subject to separate statutory requirements regarding policy setting, management, operation, and use of conformity assessment activities. It does not include the legislative or judicial branches of the Federal government.

Under 5 U.S.C. 553(b)(A), this guidance is not subject to the notice and comment requirements of the Administrative Procedure Act. Furthermore, pursuant to 5 U.S.C. 553(d)(2), this guidance is not subject to the delayed effective date requirement of the Act. The Director has chosen to publish this document for comment only to obtain input from persons who may be affected by the guidance.

This policy statement does not contain a collection of information for purposes of the Paperwork Reduction Act.

It has been determined that this action is significant for purposes of Executive Order 12866.

This action is exempt from the analytical requirements of the Regulatory Flexibility Act because notice and comment are not required for this action by section 553 of the Administrative Procedure Act or any other law.

In the Federal Register of July 9, 1982 (47 FR 30012), the agency published a tentative final monograph for OTC topical otic drug products used as earwax removal aids. Subsequently, in the Federal Register of July 30, 1986 (51 FR 27366), the agency proposed to amend this tentative final monograph to consider OTC topical otic drug products for the prevention of swimmer's ear and for the drying of water-clogged ears. At that time, no topical otic drug products for these conditions were proposed as generally recognized as safe and effective and not misbranded. The agency, however, did propose Category I (monograph) labeling for such products in case data were submitted that resulted in upgrading any ingredient(s) to monograph status in a final rule.

In the Federal Register of August 8, 1986 (51 FR 28656), the agency issued a final rule establishing part 344 (21 CFR part 344) for topical otic drug products for OTC human use. The monograph included one active ingredient for use as an earwax removal aid.

In the Federal Register of November 7, 1990 (55 FR 46914), (hereinafter referred to as the 1990 final rule) the agency published a final rule establishing that certain active ingredients that had been under consideration in a number of OTC drug rulemaking proceedings were not generally recognized as safe and effective. The 1990 final rule was effective on May 7, 1991, and included in § 310.545(a)(15) (21 CFR 310.545(a)(15)) the active ingredient acetic acid, which had been under consideration as part of this rulemaking for OTC topical otic drug products for the prevention of swimmer's ear and for the drying of water-clogged ears. After the 1990 final rule published, only two ingredients remained to be evaluated in this rulemaking: Isopropyl alcohol and anhydrous glycerin.

In the Federal Register of February 15, 1995 (60 FR 8916), the agency issued a final rule establishing that OTC topical otic drug products for prevention of swimmer's ear or for drying water-clogged ears were not generally recognized as safe and effective for OTC use and were new drugs under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). The agency listed the ingredients considered in the rulemaking (i.e., glycerin, anhydrous glycerin, and isopropyl alcohol) in § 310.545(a)(15)(ii), with an effective date of August 15, 1995, after which products containing these ingredients for these uses could no longer be initially introduced or initially delivered for introduction into interstate commerce. Acetic acid, which had been listed solely in § 310.545, was now listed in § 310.545(a)(15)(i), with the same effective date of May 7, 1991. This final rule did not affect the conclusion reached in the 1990 and 1995 final rules that acetic acid was not generally recognized as safe and effective for the prevention of swimmer's ear or for the drying of water-clogged ears. The phrase “approved as of May 7, 1991” in § 310.545(a)(15)(i) indicates when this conclusion became effective for acetic acid.

Subsequently, a drug manufacturer submitted new data (Ref. 1) to support the use of a product containing 95 percent isopropyl alcohol in a 5 percent anhydrous glycerin base for drying water-clogged ears. The agency determined that the data supported the use of this product for drying water-clogged ears (Ref. 2). Accordingly, in the Federal Register of August 16, 1995 (60 FR 42435), the agency issued a partial stay of the August 15, 1995, effective date for § 310.545(a)(15)(ii) for products containing 95 percent isopropyl alcohol in a 5 percent anhydrous glycerin base used for the drying of water-clogged ears. This partial stay applied only to products with these ingredients for drying water-clogged ears. The new data and the stay did not involve other ingredients, such as acetic acid, and did not pertain to the prevention of swimmer's ear.

The agency is lifting the partial stay of the August 15, 1995, effective date of certain provisions of the regulations for topical otic drug products for the drying of water clogged ears. The August 15, 1995, effective date for § 310.545(a)(15)(ii) remains in effect for the listed ingredients when used in topical otic drug products for the prevention of swimmer's ear.

In the Federal Register of August 17, 1999 (64 FR 44671), the agency published a proposed amendment of the monograph for OTC topical otic drug products to add conditions for marketing products with isopropyl alcohol and anhydrous glycerin for drying water-clogged ears. The proposal contained labeling in the new OTC drug format in § 201.66 (21 CFR 201.66). Concurrently, the agency proposed to remove the drying of water-clogged ears from one part of § 310.545(a)(15) by revising the headings of paragraphs (a)(15), (a)(15)(i), and (a)(15)(ii).

Interested persons were invited to submit comments on the proposal and on the agency's economic impact determination by November 15, 1999. The agency did not receive any comments in response to the proposal.

The agency concludes that a product consisting of isopropyl alcohol 95 percent in an anhydrous glycerin 5 percent base is generally recognized as safe and effective for OTC use for the drying of water-clogged ears and that such a product is not misbranded when it contains the labeling in new § 344.52 and is consistent with § 330.1 (21 CFR 330.1). No other product or ingredient has been found to be generally recognized as safe and effective for this use.

Existing part 344 currently includes only topical otic drug products used as earwax removal aids. The current headings for §§ 344.10 and 344.50 refer to a topical otic active ingredient and labeling of topical otic drug products, respectively. Accordingly, §§ 344.10 and 344.50 are changed to “Earwax removal aid active ingredient” and “Labeling of earwax removal aid drug products,” respectively. The agency is including new §§ 344.12 and 344.52 as “Ear drying aid active ingredient,” and “Labeling of ear drying aid drug products,” respectively. The agency is deleting § 344.50(e), which refers to substitution of the word “physician” for the word “doctor,” because this is now included in § 330.1(i)(23). The agency is listing the flammability warning in § 344.52(c) in § 201.66(c)(5)(ii)(C).

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4.). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Title II of the Unfunded Mandates Reform Act requires that agencies prepare a written statement and economic analysis before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).

The agency concludes that this final rule is consistent with the principles set out in the Executive Order and in these two statutes. The final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order. FDA has determined that the final rule does not have a significant economic impact on a substantial number of small entities. Further, since this final rule makes no mandates on government entities and will result in expenditures less than $100 million in any one year, FDA need not prepare additional analyses under the Unfunded Mandates Reform Act.

The purpose of this final rule is to establish conditions for OTC drug products containing alcohol and glycerin used to dry water-clogged ears. This final rule amends the final monograph for OTC topical otic drug products and will require some product relabeling. The agency's Drug Listing System identifies only one manufacturer/marketer of one stockkeeping unit (SKU) (individual product, package, and size) of OTC topical otic drug products with these ingredients for drying water-clogged ears. There may be other manufacturers/marketers not identified in sources FDA reviewed, but the agency believes there are a limited number.

The agency believes that relabeling costs of the type required by this final rule generally average about $2,000 to $3,000 per SKU. Assuming there could be as many as five affected OTC SKU's in the marketplace, total one-time costs of relabeling would be $10,000 to $15,000. The agency believes that the actual cost could be lower for several reasons.

First, the labeling in the monograph is in the new OTC drug labeling format found in § 201.66. Therefore, manufacturers will not incur any expenses determining how to state the product's labeling. Second, manufacturers will be able to incorporate product labeling changes required by the final monograph and the new general OTC drug labeling requirements at one time. Thus, the relabeling costs resulting from two different but related final rules will be individually reduced by implementing both required changes at the same time, thereby reducing the labeling cost of this final rule.

Third, the one identified manufacturer/marketer is a small entity using the U.S. Small Business Administration designations for this industry (750 employees). The agency believes that any other unidentified manufacturer of these products is probably also a small entity. Small entities tend to use simpler and less expensive labeling. In addition, based on the limited number of SKU's (usually only one) each manufacturer has to relabel, the cost for each manufacturer should be minimal. Finally, the final rule will not require any new reporting and recordkeeping activities. Thus, no additional professional skills are needed.

The agency rejected an exemption for small entities because the new labeling information is also needed by consumers who purchase products marketed by those entities. However, a longer effective date until May 17, 2003, is being provided for products with annual sales less than $25,000.

For the reasons stated above and under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commissioner certifies that this rule will not have a significant economic impact on a substantial number of small entities.

FDA concludes that the labeling requirements in this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq .). Rather, the labeling requirements are a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

The agency has determined under 21 CFR 25.31(a) 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.

The following references are on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Comment No. CP1, Docket No. 77N-334S, Dockets Management Branch.

2. Letter from W. E. Gilbertson, FDA, to N. Buc, Buc Levitt & Beardsley, attorneys for Del Pharmaceuticals, Inc., coded LET13, Docket No. 77N-334S, Dockets Management Branch.

The Transportation Equity Act for the 21st Century (TEA-21) was signed into law on June 9, 1998, as Public Law 105-178. Section 2005 of TEA-21 established a new Section 411, entitled State Highway Safety Data Improvements, in Title 23, United States Code (Section 411). Under this new program, States may qualify for incentive grant funds by adopting and implementing effective highway safety data and traffic records improvement programs that meet specified statutory criteria.

Section 411 provides that a State's highway safety data and traffic records system should have three basic components, all of which must be present if the State is to receive multiple-year grants: a committee to coordinate the development and use of highway safety data and traffic records; a systematic assessment of the State's highway safety data and traffic records; and a strategic plan for the continued improvement of highway safety data and traffic records.

Section 411 anticipated that some States may not be able to meet all three prerequisites in the first or even the second year of the Section 411 program. The statute further anticipated that the strategic plan would be the most complex, and the most time-consuming, prerequisite to meet.

Accordingly, the section provided for three types of grants: a “start-up” grant, in the amount of $25,000, to each State that is not eligible for the other grants, provided that the State certifies that it will use the grant to meet the requisite components in the following year; an “initiation” grant, in the amount of $125,000, to each State that has established a coordinating committee, has performed or updated an assessment within the last five years, and has initiated the development of a strategic plan; and an “implementation” grant, in the amount described below, to each State that has established a coordinating committee, has performed or updated an assessment within the last five years, and has developed a strategic plan.

Section 411 provided that the first two types of grants would be available for one year only, and that the third grant would be available for multiple years. In accordance with the statute, a State that initially qualifies for a start-up grant may qualify for an initiation or an implementation grant in a subsequent fiscal year, if the State meets the criteria for these types of grants. A State that qualifies for an initiation or an implementation grant in any fiscal year may receive only implementation grants in subsequent fiscal years.

Section 411 provides that the amount of funds a State receives for an implementation grant is determined by a formula. The amount is determined by multiplying the amount appropriated to carry out 23 U.S.C. 411 by the ratio that the funds apportioned to the State under 23 U.S.C. 402 for fiscal year 1997 bears to the funds apportioned to all States under 23 U.S.C. 402 for fiscal year 1997, with the following exceptions. If the State has not received an initiation or an implementation grant under the Section 411 program in a previous fiscal year, the State shall receive no less than $250,000. If the State has received either of these two grants under the Section 411 program in a previous fiscal year, the State shall receive no less than $225,000.

All grant amounts are subject to the availability of funds.

Section 411 provided that no State may receive a grant in more than six fiscal years, and a total of $32 million was authorized for the Section 411 program over a period of four years. Specifically, TEA-21 authorized $5 million for fiscal year 1999, $8 million for fiscal year 2000, $9 million for fiscal year 2001, and $10 million for fiscal year 2002. Funds may be used by States only to adopt and implement improvements to their highway safety data and traffic records programs.

Under Section 411, States are required to match the grant funds they receive as follows: the Federal share cannot exceed 75 percent of the cost of implementing the highway safety data and traffic records programs adopted to qualify for these funds in the first and second fiscal years the State receives funds; 50 percent in the third and fourth fiscal years it receives funds; and 25 percent in the fifth and sixth fiscal years.

On October 8, 1998, NHTSA published an interim final rule in the Federal Register to implement the Section 411 program. 63 FR 54044. The interim final rule described the criteria States must meet and the procedures States must follow to qualify for funding under the Section 411 program.

The interim final rule provided that, to qualify for an implementation grant, a State must demonstrate that it has established a coordinating committee, completed or updated an assessment within the five years preceding the date of its application, and developed a strategic plan.

To qualify for an initiation grant, a State need not demonstrate that it has developed a strategic plan, but must demonstrate that it has established a coordinating committee, completed or updated an assessment within the five years preceding the date of its application, and initiated the development of a strategic plan. In addition, a State may qualify for an initiation grant only if it has not received an initiation or an implementation grant under this part in a previous fiscal year.

Any State that is not eligible for an initiation or an implementation grant, and has not received any grant under the Section 411 program in a previous fiscal year can qualify for a start-up grant, in accordance with the interim final rule.

A more detailed discussion of these criteria is contained in the interim final rule.

The interim final rule stated that, to receive a grant in any fiscal year, the State must submit an application to NHTSA, through the appropriate NHTSA Regional Administrator, which demonstrates that the State meets the requirements of the grant being requested. The State also must submit the documentation listed in the regulation, including such items as a certification that the State will use the funds awarded only for the improvement of highway safety data and traffic records programs and a certification that the State will administer the funds in accordance with relevant regulations and OMB Circulars.

Further details regarding these procedures were described in the interim final rule.

NHTSA requested comments from interested persons regarding the interim final rule. Comments were due by December 7, 1998. The agency stated in the interim final rule that all comments submitted to the docket would be considered and that, following the close of the comment period, NHTSA would publish a document in the Federal Register responding to the comments and, if appropriate, would make revisions to the provisions of Part 1335.

The agency received five comments in response to the interim final rule. Comments were received from: K. Craig Allred, Director of the Utah Highway Safety Office and Chair of the National Association of Governors' Highway Safety Representatives (NAGHSR); Jo Ann Moore, Manager of the Idaho Office of Highway Safety for the State of Idaho Transportation Department (Idaho); Betty J. Mercer, Division Director of the Office of Highway Safety Planning for Michigan's Department of State Police (Michigan); Charles W. Heald, P.E., Executive Director of the Texas Department of Transportation (Texas); and Richard L. Hannerman, President of the Salt Institute (Salt Institute).

In general, the comments received in response to the interim final rule were positive. Some of the commenters indicated that they believe it is important for States to have accurate and complete highway safety data and traffic records, and they expressed their appreciation that Congress has established this incentive grant program.

The State of Michigan, for example, stated, “Traffic records data is the backbone of an effective and efficient state highway safety program. Timely and accurate data is essential for both problem identification and program evaluation. Michigan appreciates the recognition that Congress has given to this critical highway safety component by making funding available to implement essential improvements to the state highway safety data and traffic records program.” NAGHSR stated, “The grant program will provide a small but significant incentive to states to improve their state data systems through a comprehensive, planned approach.”

Other commenters provided general support for the contents of the interim final rule. The Salt Institute, for example, “wholeheartedly endorse[d] the NHTSA conclusion that an effective highway safety program “must include a process that identifies highway safety programs, develops measures to address the problems, implements the measures, and evaluates the results' and that this demands and ‘depends on the availability of highway safety data and traffic records.’ ” In addition, the Salt Institute stated that it “is pleased to endorse the data elements included in the interim final rule specifying the requirements on states to receive highway safety incentive grants for their safety data and traffic records.” NAGHSR stated that, “In general, NAGHSR supports the proposed interim regulations and believes that they are reasonable.”

Some of the commenters suggested that certain limited modifications should be made to the interim final rule, and Michigan stated, “it is our hope that the implementing regulations will be modified so that they do not deter the states from being able to take full advantage of this very needed funding source.”

The specific modifications that these commenters proposed and the agency's response to those comments are discussed in detail below. The agency notes, however, that the interim regulations did not deter the States from taking advantage of the Section 411 program. A total of $4,806,900 in grants were distributed to 54 jurisdictions (47 States, the District of Columbia, Puerto Rico, 4 U.S. Territories and the Bureau of Indian Affairs) under this program in FY 1999, and a total of $7,600,000 in grants were distributed to 46 jurisdictions (42 States, Puerto Rico and 3 U.S. Territories) under Section 411 in FY 2000.

In Section 411, Congress outlined the criteria that States must meet to qualify for incentive grants under this program. Under one of these criteria, States must have “established a highway safety data and traffic records coordinating committee with a multi-disciplinary membership, including the administrators, collectors, and users of such data (including the public health, injury control, and motor carrier communities).” Section 411 provides also that States must submit their highway safety data and traffic records strategic plans to the coordinating committee for approval.

The interim final rule provided that, to qualify for either an initiation or an implementation grant, States must have established a coordinating committee that meets certain requirements. Specifically, the committee must be made up of members drawn from the agencies and organizations throughout the State that administer, collect and use highway safety data and traffic records and have certain enumerated powers, including the authority to review any of the State's highway safety data and traffic records systems and to review changes to those systems before the changes are implemented.

The agency received comments from NAGHSR, Michigan and Texas, objecting to these requirements. Michigan's comments on this subject are both comprehensive and representative of the others received.

Michigan stated, “The Committee is a very diverse group, the actual authority to operate the system most likely lies with one of the key agencies on the Committee. The law requires only that the Committee ‘continue to operate and support the multi-year plan.’ It is more appropriate and realistic to require that the Coordinating Committee review and makes recommendations on the strategic plan but not necessarily have direct authority to approve it.”

Michigan continues, “To require the Committee to have the authority to review the state highway safety data and traffic records system and changes to the system prior to implementation is impractical and unnecessary. Michigan has had a traffic records coordinating committee for many years. The state long recognized that to have an effective program the key agencies with an interest in the data must work collaboratively. * * * Authority for any specific segment of the traffic records system, however, rests with the state agency responsible for that particular segment.” [Emphasis in text.]

Similarly, NAGHSR opposed the “expanded role” that the interim regulation seems to envision for the coordinating committee, and Texas expressed its belief that “such a formal committee * * * with such broad control over state agency operations” should not be required.

As stated previously, the statutory language in Section 411 requires that States must submit their highway safety data and traffic records strategic plans to the coordinating committee for approval. The agency believes that the portion of the interim final rule which provides that the coordinating committee must have the authority to review the State's highway safety data and traffic records systems and to review changes to those systems before the changes are implemented is necessary to implement this statutory requirement properly.

If a coordinating committee did not have this authority, the agency believes there would be no assurance that the improvements identified in the plan that need to be made will in fact be carried out. In addition, NHTSA expects that these strategic plans will be “living documents,” which may need to be altered on a continuous basis to take into account the amount of progress that has (or has not) been made and any other changes in circumstances. The agency believes that, by including the coordinating committee in the review process in this way, the committee will remain more fully informed about the State's progress in implementing the strategic plan and about other circumstances as they unfold, which will enable the committee to make adjustments to the plan, if they are needed. Accordingly, this portion of the final rule has been adopted without change.

NAGHSR also asserted in its comments that, in some regions, “states are being actively encouraged to require state agency members of the coordinating committee to sign a joint Memorandum of Understanding (MOU) * * * [which] would give formal approval authority to the coordinating committee over the state data plan.” NAGHSR states that this suggestion would be problematic for some State agencies, and suggests that it should be discontinued.

The agency acknowledges that, when some States inquired about the manner in which a State could document that they had the authority mentioned above, some of the agency's regional staff suggested to these States that they could document the authority in a Memorandum of Understanding (MOU). The agency did not mean to suggest, however, that this was a necessary requirement. As provided in the interim final rule, to demonstrate compliance with the Section 411 criterion that States must establish a coordinating committee, States need only certify that the State “has established a coordinating committee, and include the name, title and organizational affiliation of each member of” that committee. State coordinating committees may enter into MOU's if they wish, but this is not a prerequisite to Section 411 compliance.

One of the other criteria established by Congress in Section 411 is the requirement that States must have “completed, within the preceding 5 years, a highway safety data and traffic records assessment or an audit of the highway safety data and traffic records system of the State.”

The interim final rule provided that, to qualify for either an initiation or an implementation grant, States must have completed or updated an assessment within the five years preceding the date of the State's application and, further, it provided that the assessment must meet certain requirements.

Specifically, the interim regulations required that the assessment must be an in-depth, formal review of the State's highway safety data and traffic records system; that it generate an impartial report of the status of the system in the State; and that it be conducted by an organization or group that is knowledgeable about highway safety data and traffic records systems, but independent from the organizations involved in the administration, collection and use of these State systems.

In its comments, Texas objected to the requirement that the assessment must be conducted by an “organization or group that is knowledgeable about highway safety data and traffic records systems.” Texas expressed its belief that States “should be given more latitude to select a consultant experienced in a wide range of disciplines such as business process re-engineering or information systems.” According to Texas, “Limiting these efforts to consultants and organizations experienced in crash records will adversely limit the type and number of firms that will be able to compete for these assessments.”

The agency would not object to any State's decision to involve in its assessment a consultant or group with experience in a wide range of disciplines, such as business process re-engineering or information systems. However, to qualify under the Section 411 criterion that States must complete or update an assessment, the organization or group conducting the assessment must also be knowledgeable about highway safety data and traffic records systems.

This portion of the final rule has also been adopted without change.

Congress also provided, in Section 411, that States either must have “initiated the development of a multi-year highway safety data and traffic records strategic plan” that meets certain requirements or that they certify “that the highway safety data and traffic records coordinating committee of the State continues to operate and supports the multi-year plan.”

The interim final rule provided that States must have initiated the development of a strategic plan to qualify for an initiation grant, and that States must have developed a strategic plan to qualify for an implementation grant. The interim regulation further provided that the strategic plan must be a multi-year plan that identifies and prioritizes the highway safety data and traffic records needs and goals based on the State's assessment, identifies performance-based measures by which progress toward those goals will be determined, and be submitted to the coordinating committee for approval.

Michigan stated, in its comments, that it would have no difficulty meeting the requirement that States must have a strategic plan, but Michigan asserted that this requirement might be difficult for some other States. No other State raised this objection.

Texas raised two questions concerning this criterion. The State asked whether the committee's approval of the plan commits State agencies to implement the plan and it asked how differences between plans of the coordinating committee and of the State agency would be resolved.

The interim regulations provide that, to qualify for an initiation grant, a State must certify that the State “has established a coordinating committee” and that it “has initiated the development of a strategic plan, with the supervision and approval of the coordinating committee.” A State must also certify that the State “has established a coordinating committee” to qualify for an implementation grant (if the State has not received an initiation or an implementation grant under this part in a previous fiscal year). In addition, to qualify for an implementation grant (whether or not the State has received an initiation or an implementation grant under this part in a previous fiscal year), a State must certify that “the coordinating committee continues to operate and supports the strategic plan.”

The interim regulations do not require that the State submit any certifications or other information concerning the actions that State agencies must take as a result of the plan or the means of resolving issues that may arise between these agencies and the coordinating committee. It is up to each individual State to address these issues. NHTSA does not believe it is appropriate for it to dictate such matters to the States.

However, the States should note that, to qualify for an implementation grant (if the State has received an initiation or an implementation grant under this part in a previous fiscal year), a State must report on its progress in implementing the strategic plan since the State's previous application. If progress is not made in a State, due to a lack of commitment on the part of State, because of the presence of conflicts between these agencies and the coordinating committee, or for other reasons, the State's ability to receive Section 411 grant funds in subsequent years could be jeopardized.

No changes have been made to this portion of the final rule as a result of these comments.

In the provisions of Section 411, Congress provided for a maintenance of effort requirement. Specifically, Section 411 provides that, “No grant may be made to a State under this section in any fiscal year unless the State enters into [an] agreement with the [the agency] * * * that the State will maintain its aggregate expenditures from all other sources for its highway safety data and traffic records programs at or above the average level of such expenditures in [fiscal years 1996 and 1997].”

Section 411 provides also for State matching requirements. Specifically, the statute provides that “The Federal share of the cost of implementing and enforcing, as appropriate, in a fiscal year a program adopted by a State pursuant to [the Section 411 program] shall not exceed [75 percent] in the first and second fiscal years in which the State receives a grant under this section * * *; [50 percent] in the third and fourth fiscal years in which the State receives a grant under this section * * *; and [25 percent] in the fifth and sixth fiscal years * * *

The interim final rule incorporated all of these requirements into the interim regulations.

In its comments, Idaho raised two objections to these requirements. Regarding the maintenance of effort requirement, Idaho explained that it “spent an abnormally large amount [of funds] on highway safety data and traffic records systems in [fiscal years 1996 and 1997] from special funding sources that are no longer available, thereby making it impossible to continue expenditures at this inflated level.”

According to Idaho, “In fiscal year 1995, [it] received a one-time amount of $1.3 million [under the Section 153 transfer program] because the state did not have a universal motorcycle helmet law [and the State] used approximately 23 percent of those funds for highway safety data and traffic records system projects in fiscal years 1996 and 1997. As a result, expenditures for data-related initiatives in those two years, due to this “windfall” funding source, were among the highest on record for [the] agency.”

With all of the highway safety problems that the State must address, Idaho asserts that, “It would be irresponsible [for Idaho] to include in [its] highway safety plans a 25 percent yearly expenditure of 402 funds on highway safety data or traffic records systems.” Accordingly, Idaho requests that these Section 153 transfer funds not be considered as part of the baseline for the Section 411 maintenance of effort requirement.

The agency recognizes that, in fiscal years 1996 and 1997, some States expended usually large sums of money on their highway safety data and traffic records systems and that these sums were from special funding sources that are no longer available. In particular, many States experienced a transfer of funds in fiscal year 1995, under the Section 153 program, because they did not have in effect conforming motorcycle helmet or seat belt use legislation. Some of these States chose to use these funds to upgrade their highway safety data and traffic records systems and, in many cases, the funds that had been transferred in fiscal year 1995 were expended in fiscal years 1996 and 1997.

The agency believes that the maintenance of effort requirement contained in the Section 411 program was intended to ensure that States maintain their ordinary spending on their highway safety data and traffic records systems and that the funds they receive under the Section 411 program will supplement those expenditures and not replace them. The agency does not believe the requirement was intended to match special or unusual funding resources, such as the Section 153 transfer or other funds made available to States under Chapter 1 of Title 23 of the United States Code, some or all of which a State may choose to use also to supplement its ordinary spending in this area. The agency believes that the inclusion of these special funding sources in the maintenance of effort requirement would impose a hardship on the States and would not result in the most effective use of these resources.

Accordingly, the regulation has been modified to clarify that States must maintain their aggregate expenditures from all other sources, except those authorized under Chapter 1 of Title 23 of the United States Code, for their highway safety data and traffic records programs at or above the average level of such expenditures in fiscal years 1996 and 1997.

Regarding the matching requirements, Idaho observes that these requirements apply each year that a State receives a grant, whether the State receives an implementation, initiation or start-up grant, and Idaho asserts that “it would be difficult for us to meet the higher match requirements in the third and subsequent years.” Accordingly, Idaho recommends that the $25,000 start-up grant be excluded from the matching requirements and that these requirements apply instead only to initiation and implementation grants. Idaho asserts that this would assist Idaho and other small States.

The agency appreciates that, over the life of the program, it might be easier for some States to meet the matching requirements if those requirements were to apply only to initiation and implementation, and not to start-up grants. However, the statutory language in Section 411 states specifically that the various matching levels apply to fiscal years “in which the State receives a grant under this section.” The statute does not exclude any of the three types of grants that may be awarded. Accordingly, the agency will continue to apply the matching requirements to start-up, as well as to initiation and implementation, grants, and will not make any changes to this portion of the regulations.

The agency notes that the State of Idaho did not apply for a Section 411 start-up grant during FY 1999. It appears that the State decided instead to wait, and applied for and received an initiation grant in FY 2000. By following this course, Idaho was not subject to a matching requirement for the start-up funds that it spent on its data and traffic records system in FY 1999. In addition, the 75 percent Federal matching percentage was applied to the initiation grant that Idaho received in FY 2000 and will be applied also to the first implementation grant for which the State qualifies.

The agency would also like to remind the States that it will accept a “soft” match in Section 411's administration, as it has for the agency's Section 402 and 410 programs. By this, the agency means the State's share may be satisfied by the use of either allowable costs incurred by the State or the value of in-kind contributions applicable to the period to which the matching requirement applies. A State cannot, however, use any Federal funds, such as its Section 402 funds, to satisfy the matching requirements. In addition, a State can use each non-Federal expenditure only once for matching purposes.

Michigan also had a comment concerning the maintenance of effort requirement. To implement this requirement, the interim rule requires each State to certify that it will “Maintain its aggregate expenditures from all other sources for highway safety data and traffic records programs at or above the average level of such expenditures in [State or] Federal fiscal years 1996 and 1997.” Michigan explained that its funding for traffic records is appropriated by its State Legislature on an annual basis and, therefore, any certification as to the maintenance of expenditures at or above the average 1996 and 1997 level “can only be based on current year funding levels.”

The agency understands Michigan's concern. To the extent that any State's plan covers years for which the State's legislature has not yet authorized funding, we recognize that the State agency's commitment to maintain its aggregate expenditures must be subject to the availability of funds.

The interim regulations provide that, to be considered for a grant in any fiscal year, a State must submit an application that is “received by the agency not later than January 15 of that fiscal year.” Within 30 days of being informed by NHTSA that it is eligible for a grant, a State is required to submit a Program Cost Summary (HS Form 217) obligating the funds. The interim regulations also require the States to document how they intend to use the funds under this part in their Highway Safety Plans, which they submit pursuant to 23 CFR Part 1200.

Mr. Allred of Utah, who submitted comments on behalf of NAGHSR, raised several concerns regarding this portion of the interim regulations. In particular, Mr. Allred asserted that, “Unlike other grant programs, a state must satisfy a two-step approval process that is different than the process for the Section 402 program. The application deadline is different than other grant programs. The amount of time for federal review and approval is not specified which leaves approval rather open-ended. The deadline for submitting a spending plan is different than the prior October deadline for the annual Highway Safety Plan (HSP).”

To be consistent with the timetables followed in other NHTSA programs, Mr. Allred suggests that the application deadline should be changed instead to August 1. In addition, he suggests that the applications should include a spending plan, “just as States must do under the 402 program,” that NHTSA should decide which States qualify for funding under this program by September 1 and then obligate the Section 411 funds “on October 1.”

When NHTSA was developing its interim final rules for the various grant programs authorized in TEA-21, we made a conscious decision to avoid establishing the same deadline for all of these programs. We believed that, if the States were required to submit and the agency was required to review all of these applications at the same time, the workload for both the agency and the States would be extraordinary. In addition, we were concerned about the risks of delay should all of these deadlines fall near the end of each fiscal year.

Under some of the grant programs, such as the Section 405 Occupant Protection and the Section 410 Impaired Driving Incentive Grant Programs, States must enact certain types of laws to qualify for funding. Accordingly, the agency established an August 1 deadline for these programs, to provide States with additional time to enact conforming legislation.

However, State compliance with the Section 411 incentive grant program is not dependent on the enactment of legislation. Moreover, the agency believed it had established a grant application process that was relatively simple and straight-forward to follow. Accordingly, we believed that, with the publication of an interim final rule on October 8, 1998, that States would be able to submit applications for funding by the following January 15. For all of these reasons, the interim regulations established a January 15 deadline for the receipt of applications under this program.

The agency believes that the January 15 deadline has not been a limiting factor for the States. For example, in the first year of the program (the year in which the deadline would have been most likely to have had a negative impact), the agency received and approved applications from 54 jurisdictions (47 States, the District of Columbia, Puerto Rico, 4 U.S. Territories and the Bureau of Indian Affairs). In addition, this “early” application deadline permitted the agency to make early releases of Section 411 grant funds. In FY 1999, the Section grant funds were awarded in March of 1999 and, in FY 2000, these grant funds were awarded in March of 2000. We expect that Section 411 grant funds will continue to be released in future fiscal years on a similar timetable.

Regarding Mr. Allred's comment that the interim regulations require States to “satisfy a two-step approval process that is different than the process for the Section 402 program,” we believe this reference is to the provisions of the interim regulations that require that, “Within 30 days of being informed by NHTSA that it is eligible for a grant, a State shall submit to the agency a Program Cost Summary (HS Form 217) obligating the funds under this part to highway safety data and traffic records programs,” and that “The State shall document how it intends to use the funds under this part in the Highway Safety Plan it submits pursuant to 23 CFR Part 1200.”

We note that States may meet these requirements in two separate steps or they may choose to meet both of these requirements at once. The agency believes this should not be difficult for States to do, especially when applying for subsequent year grants. Accordingly, no changes are being made to the regulation as a result of this comment.

In subsection (a)(2) of Section 411, Congress stated that, “The Secretary, in consultation with States and other appropriate parties, shall determine the model data elements necessary to observe and analyze national trends in crash occurrences, rates, outcomes, and circumstances.”

In the interim final rule, NHTSA indicates that, it has determined that the Model Minimum Uniform Crash Criteria (MMUCC) serve the purposes of the law and has defined “model data elements” to mean the elements specified in the MMUCC. While conformity to the MMUCC is not required for grant eligibility under Section 411, the agency strongly encouraged States in the interim final rule to employ the criteria in their highway safety data and traffic records systems, and to consider these criteria when conducting their assessments and developing their strategic plans.

In its comments, the Salt Institute recommends a change to the MMUCC, related to data element C13 “Road Surface Condition.”

The agency notes that the Salt Institute's recommended change to the MMUCC is beyond the scope of this rulemaking action. As explained in the interim final rule, the MMUCC is a minimum set of crash data elements with standardized definitions that are relevant to injury control, and highway and traffic safety. Its use is encouraged to help States reduce the collection and processing burden of motor vehicle crash data.

The MMUCC was developed collaboratively. The effort to develop the MMUCC involved private and public safety, engineering, transportation and research experts from the local, State and Federal levels, and drafts of the data set were distributed for comment to national, State and local associations, representing highway traffic safety, injury control, emergency medical services, State health departments and others, and to the general public via the World Wide Web. The final version of the MMUCC was prepared by an expert panel, which considered the feedback it received at meetings and by mail, fax, telephone and electronic communication. The effort was supported by the National Association of Governors' Highway Safety Representatives (NAGHSR), with assistance from NHTSA and the FHWA.

Any decisions regarding the contents of the MMUCC would need to be considered through separate proceedings.

This final rule will not have any preemptive or retroactive effect. The enabling legislation does not establish a procedure for judicial review of rules promulgated under its provisions. There is no requirement that individuals submit a petition for reconsideration or other administrative proceedings before they may file suit.

The agency has examined the impact of this action and has determined that it is not significant under Executive Order 12866 and the Department of Transportation's Regulatory Policies and Procedures.

The action will not have an annual effect on the economy of $100 million or more or adversely affect in a material way a sector of the economy, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities. It will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency, and it will not materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof. Nor does it raise novel legal or policy issues.

In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612), the agency has evaluated the effects of this action on small entities. Based on the evaluation, the agency certifies that this action will not have a significant impact on a substantial number of small entities. States are the recipients of any funds awarded under the Section 411 program, and they are not considered to be small entities, as that term is defined under the Regulatory Flexibility Act.

The requirements relating to the regulations that this rule is amending that States retain and report to the Federal government information which demonstrates compliance for incentive grant funds for improved highway safety data and traffic records systems, are considered to be information collection requirements, as that term is defined by the Office of Management and Budget (OMB) in 5 CFR Part 1320.

Accordingly, these requirements have been submitted and approved by OMB, pursuant to the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). These requirements have been approved through June 30, 2003, under OMB No. 2127-0606.

The agency has analyzed this action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ) and have determined that it will not have any significant impact on the quality of the human environment.

The Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires agencies to prepare a written assessment of the costs, benefits and other affects of final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. This final rule does not meet the definition of a Federal mandate, because the resulting annual expenditures will not exceed the $100 million threshold. In addition, this incentive grant program is completely voluntary and States that choose to apply and qualify will receive incentive grant funds.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this action will not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Accordingly, a Federalism Assessment has not been prepared.

Implementation of the TRICARE Retiree Dental Program (TRDP), a program completely funded by enrollee premiums, was directed by Congress in Section 703 of the National Defense Authorization Act for Fiscal Year 1997, Public Law 104-201, which amended Title 10, United States Code, by adding Section 1076c. Section 1076c was subsequently amended by the National Defense Authorization Act for Fiscal Year 1998 to expand eligibility to retirees of the Public Health Service and the National Oceanic and Atmospheric Administration and to surviving spouses and dependents of deceased active duty members. As amended, the law directs the implementation of a dental program for: (1) Members of the Uniformed Services who are entitled to retired pay, (2) members of the Retired Reserve who would be entitled to retired pay, but are under the age of 60, (3) eligible dependents of a member in (1) or (2) who are covered by the enrollment of the member, and (4) the unremarried surviving spouse and eligible child dependents of a deceased member who died while in status described in (1) or (2); the unremarried surviving spouse and eligible child dependents who receive a surviving spouse annuity; or the unremarried surviving spouse and eligible child dependents of a deceased member who died while on active duty for a period of more than 30 days and whose eligible dependents are not eligible or no longer eligible for the Active Duty Dependents Dental Plan.

Eligibility of dependents (other than surviving spouses and dependents) for the TRDP was contingent on the enrollment of the retired member. This applied even in cases where the member could not benefit from TRDP coverage. In such cases, members had a choice of enrolling solely to obtain coverage for their dependents, or doing without the program altogether.

With regard to amending Section 1076c of Title 10 to rectify this situation, the House National Security Committee reported, “Presently, dependents may enroll in the retiree dental program only if the retired member also enrolls. However, some retired members are entitled to receive dental care from the Department of Veterans Affairs or have medical or dental conditions which preclude their use of the dental program. The Committee believes it is not reasonable to ask these retirees to enroll in, and pay premiums for, a program which offers them no benefits only so their dependents may also enroll in the program. Therefore, this provision would allow the dependents of these specific retirees to enroll in the retiree dental program independently.”

Section 702 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999, Public Law 105-261, addressed this situation by extending eligibility for the TRDP to eligible dependents of certain retired members who are not enrolled and whose benefit from enrollment would be severely limited at best. These are members who are enrolled with the Department of Veterans Affairs to receive dental care, members who are enrolled through employment in a dental plan that is not available to the member's dependents, and members who are prevented by a medical or dental condition from being able to use TRDP benefits.

The proposed rule was published in the Federal Register on December 1, 1999. No public comments were received.

The proposed rule extends eligibility for the TRDP to eligible dependents when the retired member is not enrolled because the member would not benefit from the program due to any of the three conditions stipulated in the law, which are, briefly, dental care from the Department of Veterans Affairs, employee-only dental coverage, or medical or dental condition which precludes dental care. To facilitate understanding and convey the intent of the law, the proposed rule mandates that each of these conditions must meet the test of being ongoing, long-term, or enduring as opposed to episodic, conditional, temporary, or short-term. The retired member's circumstance must be such that the benefits of the TRDP would not be useful currently and in the foreseeable future. This distinction is also necessary to help limit the potential for adverse selection and higher costs.

Given the absence of any systems of information that a member meets any of the three qualifying conditions, the proposed rule requires that retired members desiring to enroll their dependents under the dependent-only provision provide documentation attesting to the existence of these conditions. The documentation requirements are specified as being: (1) confirmation by the Department of Veterans Affairs of its authorization for the member's ongoing, comprehensive dental care, (2) confirmation by a member's employer or the employer's dental plan administrator that the member is enrolled in a dental plan through employment that is separate from the member's Uniformed Service, and the dental plan is not available to the member's dependents, or (3) confirmation by the member's physician or dentist of the member's inability to utilize TRDP benefits due to a current and enduring medical or dental condition. These criteria and documentation requirements were developed with the recognition that the three situations specified by Congress for allowing dependent-only enrollment represent exceptional circumstances.

The availability of dental care from the Department of Veterans Affairs is extremely limited. Sections 1710(c) and 1712 of title 38, United States Code, and sections 17.93, and 17.160 through 17.166 of title 38, Code of Federal Regulations specify the criteria which a veteran must meet to be considered for dental care. The policies and procedures for the Veterans Health Administration (VHA) Dental Program are covered in the VHA Directive 1130 (December 7, 1998) and the VHA Handbook 1130.1 (December 7, 1998).

The determinations of eligibility or authorization for dental care are not based simply on enrollment for health care from the Department of Veterans Affairs nor are such decisions recorded in a centralized system. These are accomplished by the Department of Veterans Affairs at local and regional levels. In general, entitlement to continuous, comprehensive dental benefits from the Department of Veterans Affairs is limited to those veterans who are in receipt of a compensable service connected dental rating, a 100% service connected rating, or a permanent and totally disabled (unemployable) rating, or who have been classified as former Prisoners of War (for at least 90 days). In most other cases, the dental care provided to eligible veterans is episodic and short-term.

Just as the dental care available from the Department of Veterans Affairs is limited, employee-only dental coverage is not prevalent in the health insurance industry according to sources at the Health Insurance Association of America and Delta Dental Plan of California. Similarly, expectations are that the prevalence of medical or dental conditions that would preclude any use for the coverage offered by the TRDP is relatively small.

The proposed rule prohibits retroactive dependent-only enrollments and requires that enrolled retirees satisfy any remaining enrollment commitment prior to enrolling dependents under the dependent-only provision. Once the initial enrollment commitment is fulfilled, retirees who meet one of the dependents-only eligibility conditions may disenroll with dependents remaining enrolled on a month-to-month basis.

In addition to implementing dependent-only eligibility, the proposed rule clarifies the process for electing to enroll in the TRDP by removing the apparently restrictive reference to written election, thereby recognizing the existence of the variety of methods in which an election of enrollment can be conveyed, e.g., by written, telephonic, or e-mailed application. The proposed rule also clarifies the 12-month enrollment lock-out provision by specifying that the provision applies to disenrollment occurring at any time and for any reason. This includes disenrollment after the enrollee has fulfilled the 24-month initial enrollment commitment and disenrollment of the retired member to convert to dependent-only coverage.

The final rule is consistent with the proposed rule.

Executive Order 12866 requires certain regulatory assessments for any “significant regulatory action,” defined as one that would result in an annual effect on the economy of $100 million or more, or have other substantial impacts.

The Regulatory Flexibility Act (RFA) requires that each federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities.

This rule is not a significant regulatory action under the provisions of Executive Order 12866, and it would not have a significant impact on a substantial number of small entities.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

The Copyright Office reviewed its regulations and, on June 28, 2000, published non-substantive, technical amendments that updated and made minor corrections to the agency's rules. The Office now makes additional clarifying technical amendments in 37 CFR part 201 and makes a correction in 37 CFR part 204 that was inadvertently overlooked in the June 28th document.

Docket, No. A-91-07, containing information relevant to this rulemaking, is available for public inspection between 8:00 a.m. and noon and 1:30 p.m. and 4:00 p.m., Monday through Friday, except for Federal holidays, at EPA's Air Docket Section. A reasonable fee may be charged for copying.

Overview . The preamble summarizes the legal authority for these revisions, background information, technical and economic methodology used by the Agency to develop these revisions, impacts of these revisions, regulatory implementation, responses to public comments, and the availability of supporting documents.

Regulated Entities. These revisions apply to certain facilities, and they may apply to others.

(a) The revisions apply to any facility that is:

(1) Required to install a new COMS, relocate an existing COMS, replace an existing COMS.

(2) Required to recertify an existing COMS that has undergone substantial refurbishing (in the opinion of the enforcing agency).

(3) Specifically required to recertify the COMS, as required in the Code of Federal Regulations (CFR).

(b) These requirements may also apply to stationary sources located in a State, District, Reservation, or Territory that has adopted these revisions into its implementation plan.

Background Documentation. The following is a list of background documents pertaining to this rulemaking:

(1) Summary of Comments and Responses to the Proposed Revisions to PS-1. July 1998. Docket item No. IV-A-01.

(2) Summary of Performance Specification 1 (PS-1) Stakeholder Meeting. June 1996. Docket item No. IV-E-01.

(3) Summary of Comments and Responses to the PS-1 Supplemental Proposal. April 1999. Docket item No. IV-A-02.

(4) The EPA Public Comment Meeting: Measurement Methods for Opacity Stack Monitoring. October 1998. Docket item No. IV-E-02.

The two Summary of Comments and Responses documents (items 1 and 3) for this final rule contain a summary of all public comments made on the rule and our response to the comments. The Summary of Performance Specification 1 (PS-1) Stakeholder Meeting (item 2) contains a brief summary of the meeting taken from a poor quality audio recording of the meeting. The EPA Public Comment Meeting: Measurement Methods for Opacity Stack Monitoring (item 4) contains a transcript of the public hearing on the Supplemental Proposal.

Technology Transfer Network. The Technology Transfer Network (TTN) is one of EPA's electronic bulletin boards. The TTN provides information and technology exchange in various areas of air pollution control. New air regulations are posted on the TTN through the world wide web at “http://www.epa.gov/ttn”.

The information presented in this preamble is organized as follows:

We published the Specifications and Test Procedures for Opacity Continuous Emission Monitoring Systems in Stationary Sources, PS-1 (40 CFR Part 60 Appendix B) in the Federal Register on October 6, 1975 (40 FR 64250). We published an amendment to PS-1 on March 30, 1983 (48 FR 13322). Since the 1983 amendment, we gained more experience and understanding of COMS performance and operation. Also, manufacturers continued to improve the design of opacity monitors. In 1989 and 1990, we conducted opacity monitor manufacturer evaluations and found varying levels of sophistication in how manufacturers tested the performance of their monitors. For example, the detection limits of some testing equipment used by the manufacturers, were found to be limiting factors in evaluating COMS. In other cases, the evaluation showed that the COMS manufacturers had identified incorrect calculation procedures as well as inclusion of a component that caused an unacceptable COMS response. Other evaluations done in 1992 identified a continuing problem of clearly depicting misalignment of the transceiver and retroreflector. In 1992, we observed COMS responses over different distances for the COMS alignment test and concluded that the alignment check needed to be done at the installation pathlength. Moreover, from 1989 to 1992, we observed the angle of view (AOV) and angle of projection (AOP) testing, conducted by 10 major manufacturers of COMS, and concluded that the AOV and AOP should be reduced from the current 5 degrees to 4 degrees. This change reflects manufacturers' improvement in the monitors' capabilities. Lastly, the primary concern of COMS data users was the capability of the monitor to measure opacity accurately at or near the applicable standard. Once the opacity level exceeds the standard, the magnitude of the emissions is of lesser concern than the duration of the exceedance. Therefore, the levels at which the opacity monitor is evaluated needed to be revised. Based on the findings of our evaluations, we decided to update PS-1 to meet current industry practices and to ensure a continued improvement in the quality of opacity data.

We proposed revisions to PS-1 in the Federal Register (59 FR 60585) on November 25, 1994. Public comments were accepted for 60 days, until January 24, 1995. We received a total of 89 individual comments from 14 separate commenters. Comments on the November 1994 proposal revealed some concern and confusion with the design specifications and with the test procedures to verify compliance with the design specifications. A summary of the public comments and EPA's response to those comments is in the docket (IV-A-01). To ensure adequate understanding of the technical issues uncovered in the comments, we held a public stakeholder meeting on June 12, 1996. Attendees included opacity monitor manufacturers, State and local agencies, EPA regional offices, and COMS owners and operators. A few of the monitor manufacturers were also members of ASTM. A summary of the stakeholder meeting is in the docket (IV-E-01). As an outcome of the stakeholder meeting, in September 1996, ASTM D22.03, a Subcommittee on Ambient Atmospheres and Source Emissions, volunteered to undertake development of a Standard Practice for opacity monitor manufacturers. The Standard Practice that they developed (1) offered additional design and performance specifications and test procedures to eliminate many of the performance problems that EPA encountered with existing COMS and (2) contributed to ensuring the quality of opacity monitoring results without restricting future technological development.

On September 23, 1998, we published a supplemental proposal in the Federal Register (63 FR 50824) to incorporate ASTM D 6216-98 by reference into the proposed revisions to PS-1. Public comments were accepted for 60 days. A total of 12 commenters responded to the supplemental proposal. A summary of the public comments and EPA's response to those comments is in the docket (IV-A-02). On October 23, 1998, by request, we held a public hearing on the supplemental proposal. A summary of the public hearing is in the docket (IV-E-02).

We received a total of 89 individual comments from 14 separate commenters on the November 24, 1994, proposed revisions. The significant comments on the 1994 proposal came from manufacturers and focused primarily on the design specification and the verification test procedures. Specifically, one manufacturer stated PS-1 should include specifications for: (1) limiting the analyzer's sensitivity to ambient light, (2) limiting the analyzer's sensitivity to AC line voltage variations, (3) limiting the analyzer's potential opacity error over the entire range of expected operating temperatures, and (4) describing the analyzer's ability to meet some normal shock and vibration criteria. Another manufacturer stated a specification and verification test should be added to determine the homogeneity of the light beam. Several manufacturers suggested terminology was needed in PS-1 to distinguish between zero drift and dust accumulation on exposed optical surfaces. Another manufacturer described in detail the shortcomings of the angle of view and angle of projection verification procedures. Specifically, the manufacturer stated that the equipment being tested should incorporate whatever field restricting devices that will be installed with the transmissometer. He felt since most light sources are chopped to differentiate between ambient light and measurement light, it needs to be specified that the nondirectional light source may be chopped if required to be compatible with the light detection scheme. Also, since some chopping rates are so high as to only be feasible with light emitting diodes, it should be allowable to use the actual source, if necessary. If the actual source is used without projection optics, and it does not provide sufficient light at 3 meters to be detectable, a shorter distance should be allowed or use the normal projection optics, if required. Each of these issues is already addressed by the ASTM D 6216-98 Standard Practice. Therefore we adopted ASTM's Standard Practice by reference into PS-1.

Several commenters requested that existing COMS that are moved or refurbished should not have to meet the requirements of this new PS-1. They argued that existing COMS would be required to have new span filters (in the PS-1 revisions, the term “span” is no longer used; it has been replaced with upscale calibration value) installed and certified if relocated or refurbished. This issue was also raised in the comments on the supplemental proposal. The relocation of a COMS is likely to have an impact on the pathlength correction factor, which will impact the upscale calibration value. A change in the upscale calibration value could necessitate a change in the upscale calibration filter. The revisions to PS-1 ensure continued improvement in the quality of opacity data being collected, primarily due to the clarification of the design specification verification procedures and the performance specifications. The procedures are written in a manner to eliminate diverse interpretations. Therefore, we are requiring relocated or refurbished COMS to meet the new PS-1.

Many commenters suggested that the 20 percent dirty window compensation should not be allowed for any COMS. The commenters believed opacity monitor manufacturers are capable of utilizing improved purge systems to prevent dirt buildup. Also, it was suggested that errors of deliberate misadjustment or neglect of maintenance of monitors could result. We agreed with the suggestion that deliberate misadjustment could occur, as well as neglect of maintenance of monitors, and the dirty window compensation is now 4 percent.

Several manufacturers commented that the calibration error test, instrument response time test, and optical alignment sight test should also be done by the manufacturer and not solely at the source by the owner or operator. Because the manufacturers have the special equipment to do these tests, we agreed that the calibration error, instrument response time, and optical alignment sight tests should be done by the manufacturer. In the supplemental proposal, we only required the manufacturers to perform the aforementioned tests. We received comments on the supplemental proposal from state regulatory agencies stating that facilities should continue to also be responsible for conducting these tests. One commenter argued that the burden on facilities would be minimal, because manufacturers' representatives typically are directly involved with initial onsite installation and testing. The final rule requires both the manufacturers and facilities to perform the calibration error, instrument response time, and optical alignment sight tests. The final rule also requires the manufacturer to conduct performance verification tests on each monitor at installation-specific conditions or at clearly defined default conditions if installation conditions are not known.

A total of 12 commenters submitted written comments about the September 23, 1998 supplemental proposal. Three people that spoke at the public hearing did not submit written comments. The most frequent comment concerned the manner in which we incorporated ASTM D 6216-98 by reference into PS-1. Representatives from ASTM believed incorporating D 6216-98 by citing the various paragraphs disrupted the flow of the Standard Practice. They felt it would be more advantageous if we incorporated the Standard Practice in its entirety. We agreed with this assessment; therefore, in this final rule, we have incorporated D 6216-98 in its entirety.

Both manufacturers and State agency representatives commented about the lack of field audit procedures to confirm the performance of the COMS after it was installed. They suggested we include the procedures that were in the 1994 PS-1 proposal (59 FR 60585) for the calibration error test, instrument response time test, and optical alignment sight test. Also, other commenters suggested that the field audit procedures should include a check of the entire monitoring system to verify that the combined opacity monitor and data recording system correctly average and record averaging period values. We agreed that field audit procedures were necessary at the source, therefore we included field performance audit procedures and made them consistent with ASTM D 6216 in terms of both terminology and technology.

Many commenters expressed concern with the amount of time allowed for opacity monitor manufacturers to comply with the new specifications. They felt 30 days was not enough time. Several manufacturers suggested they could be in compliance within 180 days. We agreed with the suggested time for compliance and moved the effective date from 30 days to 180 days after publication in the Federal Register .

Some commenters questioned our replacing the old 168-hour Conditioning Period and 168-hour Operational Test Period with an extended 336-hour Operational Test Period. Commenters suggested making the Operational Test Period, during which the zero and upscale drift tests are conducted, consistent with the 7-day drift test period for a gaseous monitoring system. Also, a few commenters asked that normal source downtime be included in the Operational Test Period. Recognizing that source owners and operators would run informal conditioning period prior to beginning the operational test period, we eliminated the 168-hour Conditioning Period and reduced the Operational Test Period from 336 hours to 168 hours. We also clarified the language in the final rule and included minimum source operating times required during the Operational Test Period for batch operations and continuous operating processes.

Other commenters questioned our retaining the calibration stability test in PS-1 when tests were included in the ASTM Standard Practice to detect opacity monitors that have short-term drift problems. They believed including the test in PS-1 was redundant and unnecessary. We agreed with the suggestion that the test was redundant, and deleted the calibration stability test from the final rule.

One commenter stated that, as proposed, the requirements relating to daily zero and upscale calibration check levels would impose manufacturing problems which would significantly increase the cost to manufacture opacity monitors. This comment was given due to the manner in which ASTM D 6216-98 was incorporated in the supplemental proposal. The commenter stated that incorporating only certain sections of the standard created unnecessary confusion regarding the applicable requirements, allowed for mis-application of the ASTM standard, and created unnecessary complexity and significantly increased costs for regulatory agencies, instrument manufacturers, and the regulated facilities. Specifically, it was stated that to meet the values in the supplemental proposal given for the zero and upscale calibration, a manufacturer would have to maintain 900 calibration filters. Although we did not agree with this interpretation of the rule, after reviewing the comments submitted on the supplemental proposal, we agreed that misunderstandings could occur with the rule as proposed. With the incorporation of the ASTM standard in its entirety, we have eliminated any confusion which may occur, and we have eliminated any unnecessary complexity in the rule. The final rule will not significantly increase the cost for regulatory agencies, instrument manufacturers, or the regulated facilities.

The ASTM D22.03 Task Group chairperson indicated in his comments on the supplemental proposal that the calibration error specification of ±3 percent opacity, the zero and upscale drift specifications of ±2 percent opacity, and the PS-1 requirements to adjust monitors when drift exceeds two times the specification (i.e., ±4 percent opacity) are inappropriate for monitoring an opacity standard below 10 percent. Special calibration attenuators and calibration techniques, not yet available on a broad basis, are needed for cases where the opacity standard is below 10 percent. He noted that imprecision allowances of this magnitude create excessive uncertainty for establishing compliance with a low opacity limit. The ASTM representative noted that ASTM D 6216-98 specifications ensure accurate COMS measurements at sources with opacity standards of 10 percent opacity or greater.

The ASTM representative also indicated that the design specification for full scale to be set at 80 percent opacity or above is inappropriate for sources where the compliance level is below 10 percent opacity. The commenter also indicated other technical issues related to continuous monitoring of opacity from sources subject to opacity standards less than 10 percent which PS-1 does not adequately address. Therefore, the ASTM opacity Task Group elected to defer consideration of these special issues in ASTM D 6216-98 and instead specified that ASTM D 6216-98 will ensure that COMS “meet minimum design and calibration requirements, necessary in part, for accurate opacity monitoring measurements in regulatory environmental monitoring applications subject to 10 percent or higher opacity standards.”

We recognize there are potential measurement errors associated with monitoring opacity in stacks especially for emission units subject to opacity limits less than 10 percent. The uncertainties in measurement accuracy result from several factors. One is the current unavailability of calibration attenuators for opacity levels below 6 percent (3 percent for single-pass instruments). There are experimental techniques under review that would allow preparation and validation of calibration attenuators at levels down to 1 or 2 percent; however, the process for manufacturing and validating such devices is not yet in place. We intend to work with the ASTM Task Group to further this development work.

A second source of potential measurement error is that associated with the calibration error allowances, the zero and upscale drift specifications, the mandatory drift adjustment levels, and the imprecision associated with the allowed compensation for dirt accumulation. The imprecision associated with these tolerances may be adequate for assuring the quality of higher opacity measurements, but may be inadequate for assuring the quality of measurements of opacity less than 10 percent. In cooperation with the ASTM Task Group, we will continue to evaluate the capabilities of COMS relative to these performance specifications. The purpose of these evaluations is to determine whether tighter specifications are achievable and whether such tighter specifications would assure data of sufficient quality at opacity levels less than 10 percent. Possible outcomes include another revision to PS-1 addressing the on-site performance requirements or a second performance specification directed at COMS used at facilities with opacity limits less than 10 percent.

A third factor is the minimum full scale range of 80 percent opacity required of COMS in PS-1. This range is necessary in many cases to ensure that short term (i.e., less than 6 minutes) excursions at high opacity levels are captured in the 6-minute average. On the other hand, the specified full scale range may be inappropriately high for accurate measurements of opacity less than 10 percent for some instruments. We, again in cooperation with the ASTM Task Group, will evaluate a number of options to address this concern. Among potential options is the reduction of the required measurement range for low opacity applications; another is a requirement for dual range output with separate calibration and drift allowances. The revised PS-1 includes an option to establish a site-specific full scale range of no less than 50 percent opacity at facilities with opacity limits less than 10 percent.

We can estimate the upper range of potential measurement error that may be associated with COMS data by using a propagation of errors statistical analysis of the calibration error, zero and upscale drift, and alignment tolerances as specified in PS-1. This very conservative approach produces a potential measurement error of about 4 percent opacity. A properly operating and aligned COMS should experience measurement error significantly less than this magnitude.

While we recognize the potential for measurement error associated with monitoring opacity where the opacity limit is less than 10 percent, we believe it is inappropriate to limit the applicability of PS-1 based on the applicable emission limit. The final PS-1 is applicable to all COMS required to be certified or recertified. Instead of limiting the applicability, the final PS-1 will take into account (through statistical procedures or otherwise) the measurement uncertainty associated with COMS measurements below 10 percent opacity. Regardless of the potential for error in low level COMS readings, you, the owner or operator, are expected to respond to and correct as soon as possible any indication of excess emissions for an opacity limit consistent with good air pollution control practices for minimizing emissions as required by Part 60 and other regulations.

All of the definitions from ASTM D 6216-98 are incorporated by reference. Comments received concerning the definitions suggested that they were subject to a variety of interpretations as written. As a result of incorporating ASTM D 6216-98 in its entirety in the final rule, we deleted redundant definitions present in the proposal and we defined terminology exclusive to PS-1 to be consistent with ASTM D 6216-98.

There were specific changes in the design specifications detailed in the 1994 proposal (59 FR 60585). These changes were a result of the opacity monitor manufacturer evaluations conducted in 1989 and 1990. Also, the specifications for voltage, temperature, and light fluctuations were introduced in the supplemental proposal (63 FR 50824). There were no comments on the specifications, only on the verification procedures for the specifications. The design specifications changes are as follows:

(1) Angle of View and Angle of Projection. The AOV and AOP are reduced from 5 degrees to 4 degrees.

(2) Calibration Drift Checking System. The COMS must provide a means to simulate a zero and an upscale calibration drift check value in order to check the COMS transmitter/receiver calibration drift. The calibration drift checking system must include, at the same time, all active analyzer internal optics with power or curvature, all active electronic circuitry including the light source, photodetector assembly, electronic or electro-mechanical systems, and hardware and/or software used during normal measurement operation. The upscale calibration check response may not be altered by electronic hardware or software modification during the calibration cycle; the response is representative of the gains and offsets applied to normal effluent opacity measurements.

(3) Alarms and Warnings. The COMS must provide operators visual or audible alarms or fault condition warnings to facilitate proper operation and maintenance of the COMS.

(4) Zero Compensations. The COMS must provide an automated means to assess and record accumulated automatic zero compensations on a 24-hour basis in order to achieve the correct response to the simulated zero device.

(5) Compensation for Dirt Accumulation. The automatic compensation for dirt accumulation on the exposed optical surfaces of the COMS must now include the compensation allowance in the 4 percent opacity tolerance for zero drift adjustment. Only those optical surfaces directly in the light beam path under normal operation to measure opacity may be measured and compensated for dust accumulation. The COMS must now provide a means to display the level of dust compensation.

(6) Opacity Monitor and External Audit Filters. The opacity monitor must now accommodate independent audits of the measurement system response to external audit filters. The external audit filter access design must ensure (a) the filters are used in conjunction with a zero condition based on the same energy level, or within 5 percent of the energy reaching the detector under actual clear path conditions, (b) the entire beam received by the detector will pass through the attenuator, and (c) the attenuator is inserted in a manner that minimizes interference from reflected light.

(7) Opacity Emissions and the Pathlength Correction Factor. The COMS must now automatically correct opacity emissions that are measured at the COMS installation location to the emission outlet pathlength. The COMS must be designed to ensure the pathlength correction factor (PLCF) cannot be changed by the end user, or the PLCF is recorded during each calibration drift check cycle, or an alarm sounds when the PLCF value is changed.

(8) Voltage, Temperature, and Light Fluctuations. As a result of incorporating ASTM D 6216-98 in its entirety, we incorporated three new design specifications to ensure that the accuracy of opacity monitor data is not affected by fluctuations in supply voltage, ambient temperature, and ambient light over the range specified by the manufacturer.

This final rule also contains some revisions to 40 CFR part 60 § 60.13(d)(1) and (d)(2) and several revisions or corrections to PS-1. These revisions and corrections were given in detail in the 1994 proposal (59 FR 60585) and the supplemental proposal (63 FR 50824). There were no comments on the revisions and corrections, which are summarized below.

We revised 60.13(d)(1) to distinguish between gaseous continuous emissions monitoring systems (CEMS) and continuous opacity monitoring systems (COMS).

We revised 60.13(d)(2) to clarify and update which parts of the COMS must be checked by the daily simulated zero and upscale calibration drift checks and to be consistent with ASTM D 6216-98.

Because the new design specifications now require that the opacity monitor exhibit no interference from ambient light, we modified the installation guidelines. The modification removes the limitation of locating the opacity monitor at a place free of interference from ambient light.

The docket is an organized and complete file of all information submitted or otherwise considered by EPA in the development of this rulemaking. The principal purposes of the docket are: (1) to allow interested parties to identify and locate documents so that they can effectively participate in the rulemaking process, and (2) to serve as the record in case of judicial review (except for interagency review materials) [Clean Air Act Section 307(d)(7)(A)].

Under Executive Order 12866 (58 FR 51735 October 4, 1993), EPA must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligation of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is, therefore, not subject to OMB review.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), 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.” Under Section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. The EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This final rule does not have federalism implications. It will 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. This final rule is a revision to an existing rule already being used by State and local governments. The revisions have no impact on how State and local governments apply the rule. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

This final rule does not contain any information collection requirements subject to the Office of Management and Budget review under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. EPA has also determined that this rule will not have a significant economic impact on a substantial number of small entities.

This final rule does not have a significant impact on a substantial number of small entities because no additional cost will be incurred by such entities because of the changes specified by the rule. The requirements of the final rule reaffirm the existing design specifications for a COMS to demonstrate conformance with PS-1. The final rule clarifies the verification procedures for the design specifications, as well as clarifies the responsibilities of manufacturers of opacity monitors and the owners/operators without placing additional burden on either parties.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under Section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

EPA has determined that this rule does not include a Federal mandate that may result in expenditures of $100 million or more for State, local, or tribal governments in the aggregate, or the private sector in any one year. This rule does not include additional requirements for the performance specifications of opacity monitors; the rule only clarifies the language in the specification. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Again, the rule does not add any new requirements; it only clarifies the existing requirements.

The National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rulemaking involves technical standards. EPA decided to use a voluntary consensus standard developed and adopted by the American Society for Testing and Materials (ASTM), ASTM D 6216-98, Standard Practice for Opacity Monitor Manufacturers to Certify Conformance with Design and Performance Specifications. This standard was chosen because it was developed by ASTM with EPA involvement. The standard used the requirements outlined in PS-1 and developed clear and concise verification procedures for the requirements. Copies of the ASTM standard can be obtained by contacting the American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, Pennsylvania 19428.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that (1) is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

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). This rule will be effective February 6, 2001.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This rule revises an existing regulation which details the performance and design specifications for continuous opacity monitoring systems. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

The site to be deleted from the NPL is: Schofield Army Barracks, Honolulu County, Oahu, Hawaii.

A Notice of Intent to Delete for this site was published in the Federal Register on May 22, 2000 (65 FR 32058). The closing date for comments on the Notice of Intent to Delete was June 22, 2000. One comment was received from the public which supported the proposed deletion.

EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and it maintains the NPL as the list of those sites. Deletion of a site from the NPL does not affect responsible party liability or impede agency efforts to recover costs associated with response efforts. Section 300.425(e)(3) of the NCP states that whenever there is a significant release from a site deleted from the NPL, the site shall be restored to the NPL without application of the Hazard Ranking System.