This rule is essential to meet the requirements of section 104 of the IIRIRA, which amended section 101(a)(6) of the Immigration and Nationality Act (Act) (codified as amended at 8 U.S.C. 1101(a)(6) and 1101 note (2002)). The definition of a BCC and related requirements are covered by section 101(a)(6) of the Act. The IIRIRA, section 104 establishes two new requirements: (1) A machine-readable biometric identifier must be included in any document issued on or after April 1, 1998, that is designated as a “border crossing identification card,” and (2) an alien who presents such a card cannot be permitted to cross the border into the United States unless the biometric identifier contained on the card matches the appropriate biometric characteristic of the alien who presents the card on or after October 1, 2002.

Section 601 of the Enhanced Border Security and Visa Entry Reform Act (Border Security Act), Public Law 107-173, 116 Stat. 543 (May 14, 2002) amended section 104 of IIRIRA to extend the deadline from October 1, 2001 to October 1, 2002 for presentation of the biometric BCC at the borders. The deadline had previously been extended from 1999 to 2001. (Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999, Sec. 410(b), Public Law 105-277, 112 Stat. 2681 (October 21, 1998)). Between October 1, 2001 and the passage of the most recent deadline extension in the Border Security Act, the Service required border crossers to present the new biometric BCC, passports, visas, other appropriate documents, or valid waivers if required. After enactment of the Border Security Act extension, the Service again accepted unexpired non-biometric BCCs. This regulation ends the acceptance of the non-biometric BCCs as required by law.

The Service and the Department of State (DOS) have realigned their responsibilities so that each agency specializes in part of the BCC adjudication and production process: The DOS adjudicates all applications for the biometric BCCs for Mexicans, and the Service produces most such BCCs. The DOS also produces some of the BCCs. Canadian BCCs are no longer produced. Canadians and certain other Canadian residents are not required to possess a visa or BCC; however, waivers of any relevant grounds of inadmissibility will continue to be required of eligible Canadians and Canadian residents. See 8 U.S.C. 1182(d)(3-4); 8 CFR 212.1(a); 8 CFR 212.4, and 8 CFR 212.7. The concept for the realignment of responsibilities for the adjudication and production of BCCs grew out of discussions with the DOS about areas where the two agencies' programs interface.

This rule eliminates the use of Form I-175, Application for Nonresident Alien Canadian Border Crossing Card, and Form I-190, Application for Nonresident Alien Mexican Border Crossing Card. It also terminates the production of Form I-185, Nonresident Alien Canadian Border Crossing Card, and Form I-586, Nonresident Alien Mexican Border Crossing Card. In addition, this rule prohibits the use of Form I-186 (previous version of the Mexican BCC Card), Form I-185 and Form I-586 BCCs. The rule also prohibits the use of the non-biometric BCC portion of the combined B-1/B-2 visitor visa and border crossing identification card (B-1/B-2 Visa/BCC) (or similar combination stamp in a passport) that the DOS issued prior to April 1, 1998. The B-1/B-2 visas contained on the older DOS-issued cards will remain valid until their expiration dates unless otherwise revoked or voided.

Under the previous procedures, both the Service and the DOS adjudicated and produced Mexican BCCs. The Service issued BCCs on Form I-586 and Form I-186. Several different revisions of the Forms have been issued (last revision 1997). The Service adjudicated about 240,000 BCC applications per year at more than 30 southwest border POEs. Approximately 180,000 BCC applications were approved annually.

The DOS adjudicated about 800,000 BCC applications per year at its eight consular posts in Mexico. The DOS non-biometric BCCs were also issued in several formats, including a document that is a combination B-1/B-2 Visa/BCC and a similar combination stamp in the person's passport. In 1998, the DOS published regulations on application procedures and criteria for the new biometric BCC (Form DSP-150). See 22 CFR 41.32. Those procedures must be followed by all Mexican applicants seeking BCCs. Following publication of this rule, the Service's previous regulations concerning applications for the older non-biometric cards will no longer be effective.

In 1998 when the biometric BCCs became available and all other versions ceased to be produced, the Service had estimated that between 2 and 5 million of the non-biometric, Service-issued BCCs remained in circulation. The number of such cards has steadily declined as the older versions of both the Service-issued and DOS-issued cards have been replaced with the biometric BCC. The Service and DOS have adjudicated and produced nearly 6 million BCCs with a biometric identifier.

Section 104 of the IIRIRA requires that each BCC issued on or after April 1, 1998, include a biometric identifier that is machine readable, and that each alien presenting a BCC on or after October 1, 2002, be refused admission unless the biometric identifier on the card matches the biometric identifier of the alien. None of the BCCs issued before April 1, 1998, contain the required biometric identifier. Thus, they cannot be accepted for admission into the United States on or after October 1, 2002. Therefore, an individual who wishes to continue using a BCC (rather than obtaining a B-1/B-2 visa at a consulate) must replace his or her older BCC with the new biometric BCC in order to be admitted to the United States on or after October 1, 2002.

The BCC portion will no longer be valid for admission because it does not contain the required biometric identifier. The B-1/B-2 visa portion will remain valid for admission until its expiration date, unless the alien is subject to a ground of inadmissibility that has not been waived. However, a holder of any B-1/B-2 visa, including a visa documented on a non-biometric BCC, must also present his or her passport, unless otherwise exempt from the passport requirement. Since the DOS-issued BCCs are considered both a nonimmigrant visa and a BCC, they will not be subject to this card replacement requirement and may continue to be used only as a nonimmigrant visa after October 1, 2002, with a passport.

No. A biometric BCC may be presented in lieu of a passport and visa. A nonimmigrant Mexican national may present any of the following documents for admission into the United States: (1) A valid, unexpired visa and unexpired passport if the alien is otherwise admissible; (2) A valid, unexpired biometric BCC (DSP-150) if the alien is otherwise admissible and provided that the inspector has matched the biometric identifier on the card to the bearer's corresponding characteristic(s). If the biometric authentication is unsuccessful, the alien cannot be permitted to cross the border, as required under section 104 of IIRIRA. A passport may be required under 8 CFR 212.6 if the BCC-bearer is not arriving from Mexico or Canada, or is arriving from Canada but has been in another country other than the United States or Canada since leaving Mexico; (3) a non-biometric DOS-issued combination BCC/B-1/B-2 visa (or similar stamp in a passport) may be accepted on the basis of the unexpired B-1/B-2 visa portion only. The non-biometric BCC portion of the card (or stamp) is no longer valid on or after October 1, 2002. As usual with a B-1/B-2 visa, a valid, unexpired passport is also required. A Form I-94 should be issued unless the individual is otherwise exempt from the Form I-94 requirement by regulation; or (4) other applicable documents may be accepted depending on the alien's eligibility for admission ( e.g., Form I-512, Authorization for Parole; Form I-194, Notice of Advance Permission to Enter as Non-immigrant Pursuant to 212(d)(3)(A) or (B) of the Act).

The application procedures for replacing a non-biometric BCC are described in the regulation published by the DOS at 22 CFR 41.32. The DOS consular officers in Mexico accept and adjudicate the application for replacement BCCs. After receiving an appropriate card order from the DOS, the Service (or DOS in some cases) will process and produce the biometric BCC (DSP-150, B-1/B-2 Visa and Border Crossing Card), through its Integrated Card Production System (ICPS). The Service sends the cards to the DOS and the DOS will then return the biometric BCC to the applicant.

Each time the bearer presents this biometric BCC to an immigration officer at the border, the officer must make sure that the biometric identifier on the BCC matches the bearer's characteristics. If the biometric identifier does not match, the person will not be admitted to the United States.

If an alien's BCC is voided and cancelled and the alien presenting the BCC does not possess other valid admission documents (such as a visa and a passport), he or she may be denied admission, unless the Service grants a discretionary waiver of the applicable ground of inadmissibility, or for an unforeseen emergency under sections 212(d)(3) or 212(d)(4) of the Act, or determines that the alien should be paroled into the United States under section 212(d)(5) of the Act. If a waiver or parole is not granted, the Service, in its discretion, may permit the alien to withdraw his or her application for admission and seek appropriate documentation for his or her future admission. See 8 CFR 235.4. In certain cases, the alien may be subject to expedited removal under section 235(b)(1) of the Act and 8 CFR 235.3. The expedited removal provisions give immigration officers at POEs the authority to order aliens removed, without further hearing or review (unless they request asylum or express a fear of persecution) if they apply for admission without proper documents, or seek to procure documentation or admission by fraud or misrepresentation. Following consultation with a wide variety of immigrant, legal, and community-based groups, the Service developed extensive detailed regulations and procedures to ensure fair and consistent application of the expedited removal process. These procedures further ensure that individuals who express fears of persecution or torture are given an opportunity for a determination of credible fear and to apply for asylum where appropriate. See 8 CFR 235.3. During the transition period of the new biometric BCC, immigration officers generally will not apply the expedited removal procedures to aliens who present only their older, non-biometric BCCs, even if they do not meet the criteria discussed above for granting a section 212(d)(4)(A) waiver. Unless there is fraud, willful misrepresentation, evidence that the applicant is an imposter, or other serious violations involved in the alien's application for a visa or application for admission, the alien will be permitted to withdraw his or her application for admission in lieu of formal removal proceedings.

If there is evidence of fraudulent documentation or willful misrepresentation, or other serious violations, the Service may take appropriate investigative and enforcement actions, where necessary. These enforcement actions may include administrative procedures and criminal charges.

Where the person is not subject to the expedited removal procedures, this rule restates the existing procedures that will be applied when a BCC is declared void and cancelled. The individual will be advised that he or she may request a hearing before an immigration judge to determine admissibility in accordance with 8 CFR 235.6 and may be represented by an attorney of his or her choice with no expense to the government. The person will be provided with a list of free legal services providers. If the applicant chooses not to have a hearing, the BCC will be cancelled and the applicant will receive a notice of the action taken and the reasons for that action. If the BCC was issued by the DOS, the Service will also notify the DOS in writing of the reasons for the voidance of the BCC. Where applicable, the alien may also be ordered removed under the expedited removal provisions.

As a result of the IIRIRA mandate and the realignment of responsibilities with the DOS, the issuance of Canadian BCCs (Form I-185) ceased as of April 1, 1998. Long existent regulations permit Canadians to travel temporarily to the United States without visas. 8 CFR 212.1(a). Currently, Canadian BCCs are used primarily for Canadian citizens and certain other Canadian residents in possession of an approved Form I-194, Notice of Approval of Advance Permission to Enter as Nonimmigrant, following a request for a discretionary waiver of inadmissibility under section 212(d)(3) of the Act. The Canadian card is both a BCC and documentation of the waiver, which is noted separately on the card. This procedure allows Canadian citizens, who would otherwise be inadmissible, to enter the United States.

Although the Canadian BCC is no longer issued, Canadians who require and are eligible for a waiver of inadmissibility still must possess appropriate documentation of the waiver. Individuals who require but do not have any documentation of a waiver of inadmissibility must apply for one according to the procedures in 8 CFR 212.4. If eligible, a waiver applicant will be issued a Form I-194, Notice of Approval of Advance Permission to Enter as Nonimmigrant. The rule further provides that an unexpired waiver of inadmissibility that was previously granted and documented on a BCC issued to a Canadian or other Canadian resident exempt from the visa requirements under 8 CFR 212.1 remains valid, although the non-biometric BCC portion of the card does not. The Service is considering alternative documentation for waivers issued to Canadians and certain other Canadian residents.

In addition, with the issuance of this rule, approvals of new applications for the exercise of discretion under section 212(d)(3) of the Act may be granted for a maximum period of 5 years. All admissions pursuant to section 212(d)(3) of the Act shall be subject to the terms and conditions set forth in the waiver authorization. The period for which the alien's admission is authorized shall not exceed the period justified, subject to the limitations specified in 8 CFR part 214 (Nonimmigrant Classes). The section 212(d)(3) waiver allows the applicant to apply for admission into the United States without reapplying for a discretionary waiver for the same grounds of inadmissibility upon each application for admission into the United States. Previous regulations restricted the granting of such waiver approvals to 1 year unless the DOS had recommended a longer period. The extension of the period of validity of waiver approvals will provide long-term documentation (the Form I-194 will be valid for up to 5 years) to approved waiver applicants.

This rule establishes the procedures to terminate the use of current non-biometric BCCs and introduces a card that is machine-readable and contains a personal biometric identifier of the alien. The rule also provides a requirement that the biometric characteristic contained in any BCC presented for admission on or after October 1, 2002, must be matched to the alien presenting the card. The rule further removes references to application forms and documents that can no longer be used. Specifically this rule:

(1) Amends 8 CFR 103.7 to remove references to Form I-175 and Form I-190.

(2) Amends 8 CFR 212.1 to prohibit the use of the former non-biometric BCCs, to add references to allow the use of the biometric DSP-150, B-1/B-2 Visa and Border Crossing Card; and to add the requirement that the biometric identifier on any BCC presented must be matched to the alien presenting the BCC at time of admission before the alien will be permitted to enter the United States.

(3) Amends 8 CFR 212.4 to extend the maximum period of validity of a waiver authorization issued under section 212(d)(3)(A) or (B) of the Act from 1 to 5 years and restructures the section for the purpose of clarity. Further amends 8 CFR 212.4 to provide that a waiver previously issued in conjunction with a Form I-185, Nonresident Alien Canadian Border Crossing Card, may remain valid although the Form I-185 itself is void.

(4) Amends 8 CFR 212.6 to change the title; add a reference to the biometric Form DSP-150, B-1/B-2 Visa and Border Crossing Card, to be issued by the DOS; specify the application process for the DOS-issued card; limit the remaining validity period of the current border crossing cards; give authority to Service officers to physically cancel the former non-biometric DOS-issued cards; and provides for the replacement of the former versions of specified Service-issued BCCs.

(5) Amends 8 CFR 214.2 to eliminate the use of the Nonresident Alien Mexican Border Crossing Card (Form I-186 or I-586) and allows for the use of the Form DSP-150, B-1/B-2 Visa and Border Crossing Card, for applications for admission of aliens pursuant to the North American Free Trade Agreement. Substantive changes have not been made to this section.

(6) Amends 8 CFR 235.1(f)(1)(iv) to reference § 212.1(c) for Mexican documentary requirements.

(7) Amends 8 CFR 264.1 to remove references to Form I-175 and Form I-190.

(8) Removes 8 CFR 264.4, which refers only to the collection of fees for applications for BCCs, in its entirety.

(9) Amends 8 CFR 286.9 to add a reference to the Form DSP-150, B-1/B-2 Visa and Border Crossing Card, where the issuance of Form I-94 is required, and to remove 8 CFR 286.9(b)(5) and (6) which referenced the collection of fees in conjunction with the former BCC applications.

(10) Amends 8 CFR 299.1 to remove the references to BCC applications (Form I-175 and Form I-190), to the “Nonresident Alien Canadian Border Crossing Card” (Form I-185), to the “Nonresident Alien Border Crossing Card (Form I-586), and to add a reference to the new DOS Form DSP-150, B-1/B-2 Visa and Border Crossing Card.

(11) Amends 8 CFR 299.5 to remove references to Form I-175 and Form I-190.

Implementation of this rule as an interim rule with provision for post-promulgation public comments is based upon the “good cause” exceptions found at 5 U.S.C. 553(b)(B) and (d)(3). The reason and necessity for immediate implementation of this interim rule is that the statutory deadlines contained in section 104 of the IIRIRA of 1996, as amended, require that only BCCs bearing a machine-readable biometric identifier may be produced on or after April 1, 1998, and that a verification of the biometric identifier for all bearers of these cards must be completed before the alien may be admitted on or after October 1, 2002. The production of the new cards began on April 1, 1998, in accordance with regulations published by the DOS, and these cards are now in use. The publication of an interim rule will promote the timely institution of procedures necessary to comply with the statute. Accordingly, since delaying the effective date of this rule is impractical and contrary to the public interest, there is good cause under 5 U.S.C. 553 to make this rule effective immediately.

The Commissioner of the Immigration and Naturalization Service, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule affects individuals who are applicants for admission. Although some applicants may be business persons, the requirement for a machine-readable biometric identifier in any BCC presented for admission after October 1, 2002 is a statutory mandate that the Service must implement. This rule further standardizes the adjudication and production processes for BCCs, thereby improving government efficiency and service to the public. It also provides greater flexibility in the permissible validity periods for waivers under section 212(d)(3) of the Act. This is anticipated to reduce the burdens on certain frequent border crossers and thereby help to improve traffic flows at the POEs.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Department has reviewed this rule in light of Executive Order 12866, section 1(b), Principles of Regulation. The Department has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and, accordingly, this rule has been reviewed by the Office of Management and Budget. The Department has assessed both the costs and benefits of this rule and has made a reasoned determination that the benefits of this regulation justify its costs. The benefits include the following: (1) Promulgation of this rule meets the statutory requirements of section 104 of IIRIRA, as amended; (2) this rule ensures consistency between the Service's regulations on BCCs and the regulations issued in 1998 by the DOS regarding the application process for the new biometric BCC (22 CFR 41.32); (3) the rule's requirement that INS inspectors must match the biometric identifier in any BCC that is presented for admission to the characteristic of the nonimmigrant card holder enhances enforcement of the immigration laws and national security by improving the verification of a border crosser's true identity; (4) the rule will reduce the ability of illegal aliens to present fraudulent BCCs at the ports and in the interior of the United States; (5) the rule maintains the validity of waivers of inadmissibility issued to certain Canadian BCC holders so that they will continue to be able to enter the country although their non-biometric BCCs are now invalid.

The costs considered by the Department include: (1) The effort required by holders of the invalid non-biometric BCC to obtain the biometric BCC (DSP-150), or a valid visa and passport by the effective date of this rule. The Department determined that the vast majority of people who wished to replace their nonbiometric BCCs had already done so by October 1, 2002 because nearly 6 million biometric BCCs have been issued since 1998, and the Service had estimated that there were between 2-5 million old cards in circulation that would require replacement; DOS also reports that the vast majority of current applicants (approximately 95%) are applying for a BCC for the first time, not replacing a nonbiometric BCC; in addition, there are no significant card processing backlogs; and (2) the costs and burdens to the public associated with the BCC application process under the DOS procedures at 22 CFR 41.32. The DOS has previously determined that the BCC application can be completed in approximately one hour and that the application fee would be $65 for adults and $13 for children under age 15. See 63 FR 16892-01 (April 7, 1998); 22 CFR 22.1 (schedule of fees).

The primary purpose of this rule and the Congressional mandate in section 104 of IIRIRA is to enhance the security of BCCs, reduce the prevalence of fraudulent documents presented by border crossers, and improve the ability of immigration inspectors to verify a card holder's identity. The benefits of implementing this rule outweigh any burdens it imposes.

This rule 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant preparation of a federalism summary impact statement.

This interim rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

This rule requires the use of Optional Form DS-156, Nonimmigrant Visa Application, and Service Form I-192, Application for Advance Permission to Enter as Nonimmigrant, and Form I-193, Application for Waiver of Passport and/or Visa, which are considered information collections under the Paperwork Reduction Act. These information collections have previously been approved for use by the Office of Management and Budget (OMB). The OMB information collection control numbers are 1405-0018, 1115-0028 and 1115-0042, respectively. This rule also eliminates Form I-185, I-175, I-190, and I-586.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 91-03-17, amendment 39-6884 (56 FR 4534, February 5, 1991), which is applicable to certain Boeing Model 747 series airplanes, was published in the Federal Register on July 1, 2002 (67 FR 44116). The action proposed to continue to require inspection of the flap tracks of the wing trailing edge flaps for adequate cadmium plating and for corrosion of certain bolt holes of the fail-safe bar, and plating of such holes, if necessary. That action also proposed to require post-modification inspections of certain bolt holes of the fail-safe bar of the flap tracks of the wing trailing edge flaps for discrepancies, and corrective actions, if necessary.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 553 airplanes of the affected design in the worldwide fleet. The FAA estimates that 169 airplanes of U.S. registry will be affected by this AD.

The actions that are currently required by AD 91-03-17 take approximately 50 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions is estimated to $3,000 per airplane.

The borescope inspection required by this AD action will take approximately 32 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the borescope inspection required by this AD on U.S. operators is estimated to be $324,480, or $1,920 per airplane.

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

Should an operator be required to accomplish the eddy current inspection, it takes approximately 40 work hours per airplane to accomplish the inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this inspection is estimated to be $2,400 per airplane.

Should an operator be required to accomplish the modification of the bolt holes, it takes approximately 256 work hours per airplane to accomplish the modification, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the modification is estimated to be $15,360 per airplane.

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 99-14-07, amendment 39-11218 (64 FR 36561, July 7, 1999), was published in the Federal Register on February 15, 2002 (67 FR 7093). The proposal is applicable to all Dassault Model Falcon 2000 series airplanes; whereas, AD 99-14-07 was applicable to all Dassault Model Falcon 2000 series airplanes, and certain Dassault Model Falcon 900EX and Mystere Falcon 900 series airplanes. The action proposed to supersede AD 99-14-07 to continue to require the following:

• Repetitive operational tests of the flap asymmetry detection system to verify proper functioning, and repair, if necessary;

• Repetitive replacement of the inboard flap jackscrews with new or reconditioned jackscrews; and

• Repetitive measurement of the screw/nut play of the outboard and center flap jackscrews to detect discrepancies, and corrective action, if necessary.

The action also proposed to remove Model 900EX and Mystere Falcon 900 series airplanes from the applicability of the existing AD. For Model Falcon 2000 series airplanes, the action also proposed to add certain repetitive measurements, delete certain repetitive measurements, and extend the interval for repetitive replacement of certain jackscrews.

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

One commenter requests adding “Amdt A” to the jackscrew part numbers (P/Ns) that are already specified by the proposed AD ( i.e. , P/Ns 5318-1, 1-5319-1, and 2-5319-1). We concur with the commenter's request, noting that the designation of “Amdt A” simply indicates a reconditioned jackscrew that has been reidentified. As such, we have determined that this change further clarifies, but does not change, the requirements of this AD. In light of this, we have added P/Ns 5318-1 Amdt A, 1-5319-1 Amdt A, and 2-5319-1 Amdt A, as appropriate, for those P/Ns that have been reconditioned and reidentified. We have revised the applicable P/Ns in paragraphs (b) through (h) of the final rule accordingly.

The same commenter requests that the final rule reference only Chapter 5-40 of the Airplane Maintenance Manual (AMM) for the operational testing, inspections, and replacement action. The commenter adds that operators are managing the jackscrew life limits and inspections, and have planned the spares and maintenance inspections based on the actions required by AD 99-14-07. The commenter considers that the corrective action can be accomplished only per Chapter 5-40 of the AMM.

We do not concur with the commenter's request that only Chapter 5-40 of the AMM should be cited in the final rule as the appropriate source of service information for the actions required by the AD. In order to accomplish the requirements of the AD, it is necessary to cite all of the service information references that were included in the proposed AD, which include various AMMs and Temporary Revisions. No change to the final rule is necessary in this regard.

We have made the following additional changes to the final rule:

• In the Summary section of the final rule, we have clarified the requirements for the repetitive measurement action. The Summary section of the proposed AD specifies repetitive measurement of the screw/nut play of the “outboard and center flap” jackscrews. However, the repetitive measurement action in paragraph (f) of the proposed AD specifies the location of the jackscrew on the “outboard flaps,” and paragraph (g) of the proposed AD specifies the “inboard flap.” For this reason, we have revised the Summary of the final rule to specify measurement of the jackscrews on the “inboard and outboard flaps.” The exact location of the affected jackscrews is specified in paragraphs (f) through (h) of the final rule.

• Although paragraphs (c) and (e) of the proposed AD specify a reconditioned jackscrew having P/N 5318-1, we have revised those paragraphs in the final rule to clarify that the correct P/N of a reconditioned jackscrew is P/N 5318-1 Amdt A.

• Although paragraphs (c)(1) and (e)(1) and Note 2 of the proposed AD did not include the date of the referenced service bulletin, we have added the date (September 16, 1999) in those paragraphs in the final rule.

• In the proposed AD, paragraph (c)(2) specifies that the jackscrew is located on the inboard flap in the “inboard” position, and paragraph (e)(2) specifies the location of the jackscrew in the “outboard” position. However, because the jackscrew could be located in either the inboard or outboard position, we have determined that the requirements in those paragraphs are unnecessary and should be deleted. In light of this, we have revised the final rule and renumbered the subparagraphs accordingly.

• In paragraph (d) of the final rule, we have clarified the location of the middle jackscrew by specifying that the jackscrew is located on the inboard flap and in the outboard position. We have also clarified the location of the jackscrew in paragraph (e) of the final rule.

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

This AD is considered to be interim action. The manufacturer has advised that it is currently developing a modification that will positively address the unsafe condition which is the subject of this AD. Once this modification is developed, approved, and available, the FAA may consider additional rulemaking.

There are approximately 45 airplanes of U.S. registry that will be affected by this AD.

The costs of performing actions required by AD 99-14-07 and retained in this AD for Falcon 2000 series airplanes are described below.

The repetitive operational test of the flap asymmetry detection system takes approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the repetitive operational test on U.S. operators is estimated to be $2,700, or $60 per airplane, per test cycle.

The measurement of the screw/nut play in the flap jackscrews takes approximately 8 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the measurement on U.S. operators is estimated to be $21,600, or $480 per airplane, per measurement cycle.

The repetitive replacement of jackscrews takes approximately 8 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. New jackscrews cost approximately $21,200 per airplane. However, the AD permits a one-time reconditioning and re-use of jackscrews, which could reduce the cost of parts by 50%. Based on these figures, the cost impact of replacement of jackscrews on U.S. operators is estimated to be between $498,600 and $975,600, or between $11,080 and $21,680 per airplane, per replacement cycle.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Airbus Model A300 B2 and B4 series airplanes; A300 B4-600, B4-600R, and F4-600R (collectively called A300-600) series airplanes; and Model A310 series airplanes, was published in the Federal Register on July 17, 2002 (67 FR 46937). That action proposed to require revising the Airplane Flight Manual to advise the flightcrew to don oxygen masks as a first and immediate step when the cabin altitude warning horn sounds.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 168 Airbus Model A300 B2 and B4; A300-600; and Model A310 series airplanes of U.S. registry will be affected by this AD. It will take approximately 1 work hour per airplane to accomplish the required actions, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $10,080, or $60 per airplane.

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

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

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

On October 7, 2002, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E5 airspace at Tazewell, TN, (67 FR 62412). This action provides adequate Class E5 airspace for IFR operations at New Tazewell Municipal Airport, Tazewell, TN. Designations for Class E airspace extending upward from 700 feet or more above the surface are published in FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR part 71.1. The Class E designation listed in this document will be published subsequently in the Order.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E5 airspace at Tazewell, TN.

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 will not have a significant economic impact on a substantial number of small entities, under the criteria of the Regulatory Fl]exibility Act.

On October 7, 2002, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by amending Class E5 airspace at Rockwood, TN, (67 FR 62413). This action provides adequate Class E5 airspace for IFR operations at Harriman City Hospital, Harriman, TN. Designations for Class E airspace extending upward from 700 feet or more above the surface are published in FAA Order 74009.K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR part 71.1. The Class E designation listed in this document will be published subsequently in the Order.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class E5 airspace at Rockwood, TN.

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 will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Airspace, Incorporation by reference, Navigation (air).

On October 7, 2002, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E5 airspace at Newport, TN, (67 FR 62414). This action provides adequate Class E5 airspace for IFR operations at Cocke County Baptist Hospital, Newport, TN. Designations for Class E airspace extending upward from 700 feet or more above the surface are published in FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR part 71.1. The Class E designation listed in this document will be published subsequently in the Order.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E5 airspace at Newport, TN.

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 will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Airspace, Incorporation by reference, Navigation (air).

On October 7, 2002, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E5 airspace at Middlesboro, KY, (67 FR 62415). This action provides adequate Class E5 airspace for IFR operations at Middlesboro—Bell County Airport, Middlesboro, KY. Designations for Class E airspace extending upward from 700 feet or more above the surface are published in FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR part 71.1. The Class E designation listed in this document will be published subsequently in the Order.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

The amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E5 airspace at Middlesboro, KY.

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 will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

History

On October 7, 2002, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by amending Class E5 airspace at Augusta, GA, (67 FR 62416). This action provides adequate Class E5 airspace for IRF operations at Millen, GA. Designations for Class E airspace extending upward from 700 feet or more above the surface are published in FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR part 71.1. The Class E designation listed in this document will be published subsequently in the Order.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class E5 airspace at Augusta, GA.

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 will not have a significant impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Aircraft navigating on J-211 currently use the 129° radial of the Johnstown, PA, VORTAC. A review by the FAA has revealed that the 129° radial of the Johnstown, PA, VORTAC has become unusable. This action revises J-211 from the Johnstown 129° radial to the Johnstown 130° radial. The FAA is taking this action to enhance aviation safety in the affected area.

This amendment to 14 CFR part 71 realigns a segment of J-211 southeast of the Johnstown, PA, VORTAC by moving it one degree from the Johnstown 129° radial to the Johnstown 130° radial. This action is necessary to ensure the safety of aircraft navigating on J-211. Because this action is needed for safety reasons, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest.

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 Department of Transportation (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.

Jet routes are published in paragraph 2004 of FAA Order 7400.9K dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The jet routes listed in this document will be published subsequently in the Order.

In the Federal Register of August 15, 2002 (67 FR 53305), FDA solicited comments concerning the direct final rule for a 75-day period ending October 29, 2002. FDA stated that the effective date of the direct final rule would be 30 days after the publication of this confirmation document in the Federal Register , unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Therefore, under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321 et al.), and under the authority delegated to the Commissioner of Food and Drugs, the amendments issued thereby will go into effect on January 2, 2003.

The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. One aspect of the 1990 amendments was that they confirmed FDA's authority to regulate health claims on food labels and in food labeling.

We issued several new regulations in 1993 that implemented the health claim provisions of the 1990 amendments. Among these were § 101.14 (21 CFR 101.14), Health Claims: General Requirements, (58 FR 2478, January 6, 1993) and § 101.70 (21 CFR 101.70), Petitions for Health Claims (58 FR 2478, January 6, 1993), which established a process for petitioning the agency to authorize health claims about substance-disease relationships and set out the types of information that a health claim petition must include. These regulations became effective on May 8, 1993.

The final rule for § 101.80 (61 FR 43433, August 23, 1996), relating sugar alcohols and the nonpromotion of dental caries (the dental caries health claim), completed the first rulemaking that we conducted in response to a health claim petition (Docket No. 95P-0003). Section 101.80(a) describes the role of fermentable carbohydrates, i.e., dietary sugars and starches, in the development of dental caries. The fermentation of these carbohydrates by microorganisms on the surface of teeth produces organic acids, which contribute to the development of dental caries through erosion of tooth enamel. Section 101.80 (b) explains that sugar alcohols are fermented by oral microorganisms more slowly than fermentable carbohydrates. Thus, the rate of acid production is lower than that from fermentable carbohydrates. Consequently, sugar alcohols, when used in place of fermentable carbohydrates, are useful as sweeteners that do not promote dental caries. Section 101.80 (c) describes the specific requirements of the dental caries health claim, including the requirement that the food bearing the claim be “sugar free” as defined by § 101.60(c)(1)(i) (21 CFR 101.60(c)(1)(i)). Section 101.80 (c) also specifies the sugar alcohols that are eligible for the claim: xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination of these (§ 101.80(c)(2)(ii)(B)). Section 101.80(c)(2)(ii)(C) further states that:

In the dental caries health claim final rule, the agency stated that for other sugar alcohols to be listed in § 101.80(c)(2)(ii)(B), a petitioner must show how the substance conforms to the requirements of §§ 101.14(b) and 101.80 and must provide evidence that the new sugar alcohol will not lower dental plaque pH below 5.7 (61 FR 43433 at 43442).

In 1997, the agency received a health claim petition (Docket No. 97P-0206) requesting that we amend the dental caries health claim regulation to include erythritol among the sugar alcohols listed in § 101.80(c)(2)(ii)(B). The petition met the requirements in §§ 101.14(b) and 101.80, including evidence from clinical studies using the indwelling plaque pH test cited in § 101.80(c)(2)(ii)(C), demonstrating that erythritol-containing foods do not lower plaque pH below 5.7. Therefore, we amended § 101.80(c)(2)(ii)(B) to include erythritol as one of the sugar alcohols that is eligible to bear a dental caries health claim (62 FR 63653, December 2, 1997).

On January 9, 2002, Arla Foods Ingredients amba, DK-8260 Viby, Denmark, (the petitioner) submitted a petition under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)). The petition requested that we: (1) Amend § 101.80 to include the sugar D-tagatose as one of the substances eligible to bear the dental caries health claim; (2) amend § 101.9 (21 CFR 101.9), the nutrition labeling regulation, to exclude D-tagatose from the definition of “sugars” (§ 101.9(c)(6)(ii)), thereby allowing a “sugar free” nutrient content claim; and (3) modify the wording of § 101.80 because D-tagatose is not a sugar alcohol. On April 19, 2001, we notified the petitioner that we had completed our initial review of the petition and that the petition had been filed for further action (Docket No. 02P-0177, Let 1) in accordance with section 403(r)(4) of the act. The April 19, 2001, letter stated that consistent with our strategy for implementation of the 1999 Pearson court decision (see 65 FR 59855, October 6, 2000), the agency would consider using its interim final rule authority under section 403(r)(7)(A)(iii) of the act to allow use of the health claim immediately upon publication of the proposal. If the agency does not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing, the petition is deemed to be denied unless an extension is mutually agreed upon by the agency and the petitioner (Section 403(r)(4)(A)(i) of the act and § 101.70(j)(3)(iii)). On July 11, 2002, FDA and the petitioner agreed to extend the deadline to publish a proposed regulation until December 2, 2002 (Docket No. 02P-0177, Let 2).

As noted by the petition, D-tagatose, the subject of this health claim, is a sugar (see Ref. 1 at page 2). D-tagatose is a monosaccharide ketohexose sugar. 1 There are four different ketohexose sugars, differing only in the orientation of the hydroxyl groups attached to the carbon atoms in positions 3, 4, and 5; the other three ketohexoses are D-fructose, D-sorbose, and D-psicose. D-fructose is the only abundant ketohexose in nature; D-tagatose occurs naturally in the human food supply at only trace amounts. D-tagatose and D-fructose differ in the orientation of the hydroxyl group at the carbon atom at position 4. The Chemical Abstracts Service Registry Number (CAS No.) for D-tagatose is 87-81-0. It has a sweetness of about 75-92 percent that of sucrose.

At the time that the dental caries health claim initially was proposed, the agency recognized that, although the prevalence of dental caries among children in the United States had been declining since the early 1970s, the overall prevalence of dental caries remained a substantial burden throughout the U.S. population (60 FR 37507 at 37509, July 20, 1995). Currently, the Department of Health and Human Services' Healthy People 2010 Objectives recognizes dental caries as the single most common chronic disease of childhood, and states that 30 percent of adults have untreated dental decay (Ref. 2). Based on these facts, FDA concludes that, as required in § 101.14(b)(1), dental caries is a disease for which the U.S. population is at risk.

Under § 101.14(b)(3)(i), the substance that is the subject of a health claim must contribute taste, aroma, or nutritive value, or any other technical effect listed in § 170.3(o) (21 CFR 170.3(o)), to the food and must retain that attribute when consumed at the levels that are necessary to justify a claim. The petition states that the intended use of D-tagatose in foods is as a nutritive sweetener, humectant, texturizer or stabilizer (§ 170.3(o)(16), (o)(21), (o)(28), (o)(32)). D-tagatose used as a sweetener contributes taste to the food. Existing § 101.80 does not specify the levels in foods of sugar alcohols necessary to justify the health claim and the current petition does not propose a qualifying level for D-tagatose. As a substitute for dietary sugars, D-tagatose will be used in foods at levels necessary to provide the desired level of sweetness in the finished product. Because D-tagatose contributes taste and other technical effects listed in § 170.3(o) to food, the agency concludes that the preliminary requirement of § 101.14(b)(3)(i) is satisfied.

On May 11, 2001, the petitioner notified FDA of its view that D-tagatose is generally recognized as safe (GRAS), through scientific procedures, for use as a bulk sweetener, humectant, texturizer, or stabilizer in a variety of foods. FDA replied to this notice on October 25, 2001, stating that based on the information provided by the petitioner, as well as other information available to FDA, the agency had no questions regarding the petitioner's determination that the intended use of D-tagatose is GRAS (Agency Response Letter to GRAS Notice No. GRN 000078, October 25, 2001) (Ref. 1, Appendix 2). Furthermore, FDA is not aware of any scientific evidence that D-tagatose, under the intended conditions of use, would be harmful. The agency has not made its own determination regarding the GRAS status of D-tagatose, however, and notes that authorization of a health claim for a substance should not be interpreted as affirmation that the use of the substance is GRAS.

The petitioner's May 11, 2001 submission reveals significant evidence supporting the safety of the use of D-tagatose as a sweetener. FDA is not aware of any evidence that provides a basis to reject the petitioner's position that the use of D-tagatose as a sweetener is safe and lawful. Therefore, FDA concludes that the petitioner has satisfied the requirement of § 101.14(b)(3)(ii) to demonstrate that the use of D-tagatose as a sweetener is safe and lawful.

In the preamble to the 1996 dental caries health claim final rule, the agency concluded that there was significant scientific agreement among qualified experts to support the relationship between certain sugar alcohols and the nonpromotion of dental caries (61 FR 43433). The agency noted that it would take action to add additional sugar alcohols to this regulation when presented with evidence that the additional sugar alcohols will not lower plaque pH below 5.7, and that the substance conforms to the requirements of § 101.14(b) (61 FR 43433 at 43442).

In 1997, the agency amended the dental caries health claim to add erythritol as an additional sugar alcohol eligible for the claim (62 FR 63653, December 2, 1997). The petition to amend § 101.80 to add erythritol (Docket No. 97P-0206) presented scientific data from a rodent cariogenicity study and from a clinical indwelling plaque pH test of erythritol. The agency was satisfied that the results of these two studies were consistent with the results of the studies that investigated the cariogenic potential of the sugar alcohols listed in § 101.80(c)(2)(ii)(B) and that erythritol met the requirements of § 101.14(b). Therefore, erythritol was added to the list of eligible sugar alcohols.

The substance that is the subject of the current petition, D-tagatose, is a sugar rather than a sugar alcohol. However, like the sugar alcohols, the intended food ingredient use of D-tagatose is as a nutritive sweetener with reduced caloric value relative to traditional sugars. Also, as is the case with the sugar alcohols, the potential dental health benefit from D-tagatose derives from its reduced fermentability relative to traditional sugars. Consequently, the criteria that were used to evaluate the sugar alcohols in the existing dental caries health claim can be applied to D-tagatose to assess whether it qualifies for such a claim. As discussed in section II.C of this document FDA has concluded that D-tagatose satisfies the requirements of § 101.14(b).

In the initial proposal to authorize a health claim relating sugar alcohols and nonpromotion of dental caries (60 FR 37507, July 20, 1995), FDA considered evidence about the cariogenic potential of several specific sugar alcohols from long-term controlled human caries trials, in vivo and in vitro plaque pH measurements, demineralization and remineralization techniques, and rat caries experimental models. FDA's review focused on the scientific evidence from studies evaluating changes in plaque pH, plaque acid production, decalcification or remineralization of tooth enamel, and the incidence of dental caries with sugar alcohols. FDA limited its review to these types of studies because previous Federal Government and other authoritative reviews had focused on these areas, and the majority of research efforts have also focused on these areas (60 FR 37507 at 37523). The well-established role of sucrose in the etiology of dental caries is related to the ability of sucrose to be metabolized by oral bacteria into extracellular polymers that adhere firmly to the tooth surfaces (i.e., plaque), at the same time forming acids that can demineralize tooth enamel. FDA previously concluded that human studies show sugar alcohols, relative to sucrose, are associated with reduced rate of acid production in dental plaque and, in some studies, a reduced incidence of dental caries (60 FR 37507 at 37523).

The current petition to amend the dental caries health claim requires FDA to consider the effects of a sugar, D-tagatose, on the rate of acid production in dental plaque and thus on the incidence of dental caries. To determine whether there is an association between D-tagatose and the nonpromotion of dental caries, FDA compared scientific evidence regarding the cariogenic potential of D-tagatose from two human studies investigating the rate of acid production in dental plaque from D-tagatose relative to that of sucrose with the similar evidence that the agency had previously reviewed regarding the cariogenic potential of certain sugar alcohols. Upon review of this evidence, FDA concluded that, like the sugar alcohols previously authorized for this health claim, D-tagatose is associated with the nonpromotion of dental caries.

The petition included reports (Ref. 1, Appendix 3) from the evaluation of D-tagatose using the indwelling plaque pH test described in “Identification of Low Caries Risk Dietary Components,” T. N. Imfeld, Volume 11, Monographs in Oral Science , 1983, which is incorporated by reference in the dental caries health claim regulation (§ 101.80(c)(2)(iii)(C)). This evaluation was conducted twice under the same test protocol and with the same six test subjects. The purpose of the repeat test was to investigate the potential for oral bacteria adaptation to D-tagatose.

Each of the six subjects of these trials had his or her normal dental prosthesis replaced with a mandibular bridge-work that contained a miniaturized telemeterized glass pH-electrode that transmits pH data to an external recording device. Once the telemetric pH prosthesis was inserted into the subject's mouth, the subject was asked not to alter his or her eating habits. The prostheses remained in place throughout the test period to allow an undisturbed growth of plaque over the tips of the pH-electrodes. With the exception of water rinses, the subjects also were asked to refrain from all oral hygiene measures. Following a 3- to 7-day plaque buildup period, the interdental plaque pH telemetry test was conducted. The two tests differed only in that, for the first test, exposure to D-tagatose was limited to a single 2-minute rinse during the pH measurements that followed the plaque buildup period; in the second test, subjects rinsed with D-tagatose five times per day throughout the 3- to 7-day plaque buildup period to determine whether the oral bacteria could adapt to utilize D-tagatose.

For both tests, baseline plaque pH was measured over a 15-minute period after the subjects chewed a piece of paraffin for 3 minutes. The subjects then rinsed with a 10-percent aqueous solution of D-tagatose, followed by plaque pH measurements over a 30-minute period. The same paraffin chew and rinse sequence was then repeated using a 10-percent sucrose rinse. The sucrose rinse served as a positive control to demonstrate the accurate functioning of the pH telemetric equipment and of plaque metabolism.

The results of these tests showed that baseline plaque pH, following the first paraffin chew, ranged from 6.7 to 7.15. The report of these two studies notes that baseline plaque pH in these trials was comparable to that of previous trials of other substances conducted with the same subjects and plaque ages (Ref. 1, Appendix 3). During the D-tagatose rinse and the 30 minutes following the D-tagatose rinse, lowest plaque pH recorded among the six subjects ranged from 5.7 to 6.55. During and after the sucrose rinse, lowest plaque pH recorded among the six subjects ranged from 4.10 to 4.90. Plaque pH measurements during the first test (without exposure to D-tagatose during the plaque build-up period) and the second test (with daily D-tagatose exposure during the plaque buildup period) were substantially the same. The report of these studies concluded that no critical decrease (i.e. below pH 5.7) in the pH of interdental plaque due to bacterial fermentation of D-tagatose occurred; and that dental plaque layers having grown up under repeated exposure to D-tagatose were not more acidified by D-tagatose bacterial fermentation than were nonexposed plaque layers in the same volunteers. Although these two reports of in vivo dental plaque pH tests of D-tagatose constitute a limited body of scientific evidence on the cariogenic potential of D-tagatose, we are satisfied that these reports, in conjunction with the information previously considered by the agency on the etiology of dental caries and the effects of slowly fermentable carbohydrates, are sufficient to enable the agency to evaluate whether D-tagatose should be added to the list of substances eligible for the dental caries health claim.

FDA previously concluded that there is significant scientific agreement among qualified experts to support the relationship between certain sugar alcohols and the nonpromotion of dental caries in that the rate and amount of acid production from the metabolism of sugar alcohols by bacteria is significantly less than that produced from the metabolism of sucrose and other fermentable carbohydrates and therefore does not cause the loss of important minerals from tooth enamel (§ 101.80(b)). The petition contains evaluations of the cariogenic potential of D-tagatose from two indwelling plaque pH tests. As discussed previously, the results of the plaque pH tests demonstrate that D-tagatose does not lower plaque pH below 5.7 and, therefore, does not promote demineralization of dental enamel. The results of these studies are consistent with the results of the studies that investigated the cariogenic potential of the sugar alcohols originally listed in § 101.80(c)(2)(ii)(B), and are consistent with the evidence relied upon by the agency when adding erythritol to this list. Therefore, based on the totality of publicly available evidence pertaining to the cariogenicity of D-tagatose and to the relationship between dental plaque pH and dental caries, we conclude that there is significant scientific agreement that D-tagatose does not promote dental caries. Accordingly, we are amending § 101.80 to authorize a dental caries health claim for D-tagatose.

Section 101.80 (c)(2)(ii)(A) (the dental caries health claim regulation) requires that foods bearing the health claim be “sugar free” as defined by (§ 101.60(c)(1)(i) (21 CFR 101.60(c)(1)(i)). D-tagatose is a sugar under the nutrition labeling definition of “sugars” 2 in 21 CFR 101.9(c)(6)(ii); therefore, by definition, a food containing D-tagatose is not “sugar free.” The petition urges FDA to amend § 101.9(c)(6)(ii) to exclude D-tagatose from the “sugars” definition, thereby qualifying D-tagatose-containing foods for the “sugar free” nutrient content claim, and to provide for a separate declaration of D-tagatose in nutrition labeling. The stated purpose of this request was to assure consistency with other regulations, and to permit D-tagatose-containing noncariogenic foods to inform consumers that the product is “sugar free” in accordance with 21 CFR 101.60. (Ref. 1). However, the effect of this request also would be to alter the reported information in the nutrition label for foods containing D-tagatose, because if the request were granted, the amount of D-tagatose in the product would not be recorded under sugars. Thus, products containing D-tagatose and no other sugars would appear to contain zero sugars for purposes of the nutrition label.

The petition identifies D-tagatose as a sugar but asserts that: (1) There is no compelling health or nutritional reason for D-tagatose to be included in the nutrition labeling “sugars” definition and (2) excluding D-tagatose from the “sugars” definition will help address public health concerns about tooth decay and will improve the ability of the label to assist consumers in maintaining healthy dietary practices with respect to dental health. The petition asserts that not excluding D-tagatose from the definition of “sugars” will frustrate efforts to address the public health concerns about dental caries.

FDA disagrees with these arguments. D-tagatose is a sugar (Ref. 3), unlike sugar alcohols, which are not; therefore, a sugar-free claim for D-tagatose would be neither scientifically accurate nor truthful. Moreover, the petition provides no data to support the assertion that identifying D-tagatose as a sugar in the nutrition label will frustrate efforts to address public health concerns about dental caries. This interim final rule provides the petitioner with an opportunity to use health claim label statements to promote the usefulness of D-tagatose as a sweetener that does not promote dental caries. The agency does not believe that a “sugar free” nutrient content claim is essential to the effectiveness of the dental caries health claim in communicating the usefulness of D-tagatose as a sweetener that does not promote dental caries.

The petition also asserts that the metabolic and nutritional characteristics of D-tagatose are sufficiently different from those of dietary sugars to justify excluding D-tagatose from the sugars definition for nutrition labeling purposes. The petition further states that, unlike dietary sugars and similar to sugar alcohols, D-tagatose passes unabsorbed through the small intestine on to the large intestine where it is reduced to short chain fatty acids via fermentation by intestinal bacteria; for this reason, and because D-tagatose is intended to substitute for dietary sugars, the petition argues that D-tagatose should be exempted from the “sugars” definition as are the sugar alcohols.

FDA disagrees with these assertions. FDA had proposed to include the sugar alcohols within the nutrition labeling definition of “sugars” in the “Food Labeling; Reference Daily Intakes and Daily Reference Values” proposed rule (56 FR 60366 at 60369, November 27, 1991). However, as explained in the 1993 final rule, we were persuaded by public comments to revise our “sugars” definition to exclude the sugar alcohols in recognition of their usefulness as sugar substitutes in reducing the cariogenic potential of foods, and because of their metabolic differences from dietary sugars, e.g., differences in intestinal digestion and absorption (58 FR 2079 at 2099, January 6, 1993). We agree with the petitioner that these are attributes that the sugar alcohols and D-tagatose have in common. However, a critical difference is that sugar alcohols are sugar-like substances used in foods to substitute for sugars, whereas D-tagatose is a sugar. The current situation, therefore, is distinguishable from our previous decision to exclude sugar alcohols from the nutrition labeling “sugars” definition.

We also had considered, in the 1993 mandatory nutrition labeling final rule, public comments urging the exclusion of lactose from the nutrition labeling “sugars” definition. These comments argued that lactose, the disaccharide sugar of dairy products, should be excluded from “sugars” because, due to its inefficient intestinal digestion and absorption, the metabolism of lactose more closely resembles that of complex carbohydrates than that of simple sugars (58 FR 2079 at 2098). FDA disagreed, stating:

Thus, although in 1993, FDA cited slow intestinal digestion and absorption among the factors considered in our decision to exclude sugar alcohols from the definition of “sugars,” those same factors were rejected as a rationale for excluding lactose because, unlike sugar alcohols, lactose is clearly a sugar within the traditional definition and usage of the term, as well as by conventional standards. Likewise, D-tagatose is clearly a sugar within the traditional definition and usage of the term, as well as by conventional standards (Ref. 3).

The petition asserts that identifying noncariogenic D-tagatose-containing foods as “sugar free” is fully consistent with the commonly understood meaning of a “sugar free” food and fully consistent with consumer expectations. The petition further argues that to exempt D-tagatose from the “sugars” definition, and thereby allow a “sugar free” claim, would provide consumers with critical information needed to select noncariogenic foods, reduced calorie foods, and foods that help diabetics follow healthy dietary practices.

FDA is not persuaded by these arguments. The petition contains no consumer survey data with regard to consumer understanding or expectations of “sugar free” nutrient content claims. Absent factual support for the petitioner's assertion that a “sugar free” claim on a food sweetened with D-tagatose is consistent with consumer understanding and expectations (to which we are open and which we would consider), FDA finds no reason to depart from the accepted scientific classification of D-tagatose as a sugar (Ref. 3). We remain skeptical that a “sugar free” claim on the food label is critical information needed for consumers to select D-tagatose-containing noncariogenic foods when such foods will be permitted to bear the dental caries health claim to identify them as noncariogenic. Neither are we convinced that a “sugar free” claim is critical information required for consumers to be able to select reduced calorie foods. The “calories per serving” declaration in the nutrition label, not a “sugar free” claim, is the primary food label information that identifies the energy content of the food. Further, if a food meets the criteria for a “reduced calorie” food (described in § 101.60(b)), the food may bear such a claim regardless of the sugar content of the food. Finally, the subject of this health claim petition is D-tagatose and nonpromotion of dental caries. A consideration of labeling information useful to identify foods that help diabetics follow healthy dietary practices is clearly outside the scope of this petition. This health claim petition contains no scientific data regarding the appropriateness of recommending D-tagatose for use by diabetics, and FDA has not evaluated any such information.

Finally, the petition asserts that excluding D-tagatose from the nutrition labeling “sugars” definition would allow consistency between the dental caries health claim, the “sugar-free” nutrient content claim, and nutrition labeling. The petition also asserts that consumers will be thoroughly confused by a nutrition label showing a food to contain sugars when the food label also bears a “Does not promote tooth decay” health claim. The petition contains no data to measure the extent of consumer understanding, misunderstanding, or confusion from foods labeled both as noncariogenic and as containing sugars. Therefore, we have no basis, other than the petitioner's subjective views, to evaluate whether or not consumers would be confused. We note that, in the future, it would be helpful to have data like this submitted along with the petition. If such data are submitted, FDA will consider them.

In summary, the petition presents two main arguments for why FDA should omit D-tagatose from the term “sugars” as used in the nutrition labeling of foods so as to permit D-tagatose-containing foods to be labeled as “sugar free”: (1) There is no compelling nutritional or public health reason to include D- tagatose within the definition of “sugars,” and (2) identifying D-tagatose as a sugar will frustrate efforts to communicate the potential dental health benefits of D-tagatose. The agency notes that the dental caries health claim, which is the subject of this health claim petition, is the most direct vehicle for promoting the dental health benefits of the substance. Should there be some potential misunderstandings on the part of consumers regarding the health claim, such problems can be addressed by refining the wording of the health claim. The declaration of “sugars” in the nutrition label and the use of “sugar free” nutrient content claims are not label information intended to communicate the specific disease-related health benefits (e.g., nonpromotion of dental caries) of a food. Moreover, this situation is not analogous to FDA's decision to exclude sugar alcohol, a nonsugar substance, from the “sugars” declared in nutrition labeling. To grant the petitioner's request would be to allow a labeling claim identifying a sugar as a nonsugar. Such a claim would be both false and misleading. For these reasons, FDA is not amending § 101.9(c)(6)(ii) to exclude D-tagatose, a sugar, from the definition of “sugars.”

The dental caries health claim regulation requires that a food bearing the health claim meet the requirements of § 101.60(c)(1)(i), the “sugar free” nutrient content claim (§ 101.80(c)(2)(ii)(A)). As discussed earlier, we are satisfied that the scientific evidence presented in the petition demonstrates that the cariogenic potential of D-tagatose, like that of certain sugar alcohols, is significantly lower than the cariogenic potential of sucrose. However, because D-tagatose is a sugar, we believe that it would be false and misleading to allow D-tagatose containing foods to bear a “sugar free” claim. Consequently, rather than granting the petitioner's request and allowing a sugar to declare itself to be “sugar free,” we instead are exempting D-tagatose from the “sugar free” requirement for the dental caries health claim by amending redesignated § 101.80(c)(2)(iii)(A) to provide that a food bearing the claim be “sugar free” except for D-tagatose.

We do recognize that there is a potential incongruity in declaring D-tagatose as a sugar in the nutrition label of a D-tagatose-containing food bearing the dental caries health claim stating that foods high in sugars promote tooth decay. To address this concern, we are adding a new provision in the “Nature of the Claim” paragraph to inform consumers about the uniqueness of D-tagatose as a noncariogenic sugar. New § 101.80(c)(2)(i)(H) will provide that where D-tagatose is the substance referred to by the dental caries health claim, the claim must identify D-tagatose as a sugar that, unlike other sugars, does not promote tooth decay or dental caries.

This interim final rule affects speech because it grants the petitioner's request to authorize a health claim for D-tagatose and dental caries, while denying the petitioner's request to permit a “sugar free” nutrient content claim for foods containing D-tagatose. Because Government regulation of food labeling and other commercial speech has constitutional implications, we are providing an analysis explaining why our decision is consistent with the first amendment.

Speech that is inherently misleading is not protected by the first amendment and may be prohibited. ( Central Hudson Gas & Electric Corp. v. Public Service Comm'n , 447 U.S. 557, 563-64 (1980)). The Supreme Court has labeled as misleading, and thus not protected, both speech that is inherently likely to deceive and that “experience has proved * * * is subject to abuse.” ( In re R.M.J. , 455 U.S. 191, 203 (1982)). The agency believes that a sugar-free nutrient content claim for D-tagatose would be inherently likely to deceive, because it is simply untrue. D-tagatose is a sugar and thus, by definition, cannot be sugar-free.

However, even if a sugar-free nutrient content claim for D-tagatose would be only potentially misleading, FDA's decision not to permit such a claim, but to authorize a dental caries health claim for D-tagatose by making an exception to the sugar-free requirement, is constitutional. The Government may place restrictions on commercial speech that is merely potentially misleading as long as the Government interest is substantial, the restrictions directly advance the Government interest, and the restrictions are no more extensive than necessary to serve that interest. ( Central Hudson , 447 U.S. at 566). FDA's authorization of the dental caries health claim by making an exception to the sugar-free requirement for foods containing the sugar D-tagatose, rather than allowing such foods to be considered “sugar free” and to bear a sugar-free claim as the petitioner requested, passes this test.

First, the Government has a substantial and compelling interest in ensuring that food labels are truthful, nonmisleading, and scientifically valid. More specifically, FDA's interest in preventing deceptive nutrient content claims from being made is clearly substantial. The food labeling regulations seek to ensure that consumers have access to information about food that is scientifically valid, truthful, reliable, understandable, and not misleading. (58 FR 2478 at 2526, January 6, 1993). Consumers have a first amendment interest in obtaining information on which to base a decision regarding whether to buy a product, and this interest is “served by insuring that the information is not false or deceptive.” ( National Comm'n on Egg Nutrition v. FTC , 570 F.2d 157, 162 (7th Cir. 1977), cert. denied , 439 U.S. 821 (1978)).

Second, this interim final rule regulating D-tagatose claims in food labeling directly advances the Government interest. It allows the petitioner and other marketers of D-tagatose to publicize the benefits of D-tagatose in not promoting dental caries, without causing the product to carry a false nutrient content claim (i.e., calling itself sugar-free when it is actually a sugar). Thus, the interim final rule reasonably and effectively ensures that claims for D-tagatose on food labels will be scientifically valid, informative, and not misleading.

Finally, FDA's regulation of D-tagatose claims in food labeling is no more extensive than necessary to serve the Government interest. Under City of Cincinnati v. Discover Network, Inc. , regulations that are narrowly tailored to serve the government interest will meet this prong of the Central Hudson test. (507 U.S. 410, 418n.13 (1993); see also 44 Liquormart, Inc. v. Rhode Island , 517 U.S. 484, 507-08 (1996)). “A regulation need not be absolutely the least severe that will achieve the desired end,” but in determining whether a restriction on commercial speech is reasonable, an agency must consider whether there are “numerous and obvious less-burdensome alternatives.” (id.) By exempting D-tagatose from the sugar-free requirement, rather than allowing a sugar to carry a sugar-free claim, FDA has found a reasonable balance between the interest in making information available about the relationship between D-tagatose and dental caries and the interest in ensuring that information about D-tagatose on food labels is truthful, nonmisleading, and scientifically valid. The restriction on “sugar-free” claims for foods containing D-tagatose is no more extensive than necessary to serve the Government's interest in preventing the dissemination of false and misleading information through food labeling, and there do not exist numerous and obvious less-burdensome alternatives in this case.

Moreover, we know of no disclaimer that could cure the deception that would be caused by allowing a sugar to be called “sugar free.” ( See Continental Wax Corp. v. Federal Trade Comm'n , 330 F.2d 475 (2d Cir. 1964) (holding that no disclaimer could cure the deception implicit in the name “Continental Six Month Floor Wax” where the evidence showed that the wax would not be effective for 6 months)). Where “the offending deception is caused by a clear and unambiguous false representation implicit in the product's name,” courts routinely deny the use of disclaimers because “the addition of a qualifying phrase denying the truth of that representation would lead to a confusing contradiction in terms.” (id. at 479-80; see also Bakers Franchise Corp. v. Federal Trade Comm'n , 302 F.2d 258, 261 (3d Cir. 1962) (use of the phrase “Lite Diet” with the phrase “not a low calorie bread” or “not low in calories” would be “a contradiction in terms and would completely confuse the public” where the bread at issue contained the same number of calories as other white bread but had thinner slices)). Here, allowing a sugar to be exempted from the definition of “sugars” and thus market itself as “sugar-free” would be inherently misleading. We are not aware of any evidence that a disclaimer could cure this deception, and common sense counsels against any such conclusion.

Thus, this interim final rule, allowing the dental caries health claim for foods containing D-tagatose but prohibiting “sugar-free” claims for such foods, meets the Central Hudson test and does not violate the first amendment.

Although in this interim final rule we are responding to a specific petition to authorize a claim about D-tagatose and dental caries, we are amending § 101.80 to establish a framework that will allow the agency to readily add to the list of eligible substances additional noncariogenic sugars, as well as additional sugar alcohols. This will provide flexibility for the inclusion of other noncariogenic carbohydrate sweeteners when adequate data are provided to demonstrate that they do not lower plaque pH below 5.7 and, therefore, that they do not promote tooth decay.

We are amending the title of § 101.80 to reflect that the amended regulation includes a noncariogenic sugar, in addition to sugar alcohols, as a substance that is eligible for the health claim about nonpromotion of dental caries. The amended title is: “Health Claims: dietary noncariogenic carbohydrate sweeteners and dental caries.” Throughout the regulation references to “sugar alcohols” have been changed to “noncariogenic carbohydrate sweeteners.”

Section 101.80 (c)(1) specifies that all of the requirements set forth in § 101.14 are to be met, except that sugar alcohol-containing foods are exempt from § 101.14(e)(6). Section 101.14(e)(6) specifies that, except for dietary supplements or where provided for in other 21 CFR part 101 regulations, foods making health claims must contain 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per reference amount customarily consumed before any nutrient addition. We are amending § 101.80(c)(1) to broaden the exception from the nutrient content requirement in § 101.14(c)(6) to include foods sweetened with any noncariogenic carbohydrate sweetener listed in new paragraph (c)(2)(ii) of this section, including D-tagatose, because of the public health benefit of having a dental caries health claim on the types of foods to which these noncariogenic sweeteners may be added (i.e., chewing gums and confections).

Section 101.80 (c)(2)(i) contains requirements on the nature of the claim. For simplicity, we are allowing D-tagatose to be identified in the claim statement as “tagatose.” In addition to expanding the coverage of this section from “sugar alcohols” to “noncariogenic carbohydrate sweeteners,” we are adding new paragraph (c)(2)(i)(H) to require that when a noncariogenic sugar, such as D-tagatose, is the subject of a claim, the claim must explain that the substance is a sugar, but unlike other sugars, does not promote the development of dental caries.

As part of establishing a framework to facilitate the addition of other noncariogenic carbohydrate sweeteners to the dental caries health claim, we are adding a new paragraph (c)(2)(ii) to § 101.80 in which to list substances eligible for the claim. This format is consistent with that of most other authorized health claim regulations in which the specific requirements of the claim (§ 101.80 (c)(2)) are divided into three parts: (c)(2)(i) Nature of the claim, (c)(2)(ii) Nature of the substance, and (c)(2)(iii) Nature of the food. Existing § 101.80 (c)(2)(ii) is redesignated as § 101.80 (c)(2)(iii).

The list of sugar alcohols eligible for the dental caries health claim, which is now in the “Nature of the food” section, is being moved to new § 101.80 (c)(2)(ii)(A). The noncariogenic sugars currently eligible for the claim, i.e., D-tagatose, are being listed in new § 101.80 (c)(2)(ii)(B).

Redesignated § 101.80 (c)(2)(iii) contains requirements on the nature of the food bearing the dental caries health claim. Current § 101.80 (c)(2)(ii)(A), redesignated as § 101.80 (c)(iii) (A), reads “The food shall meet the requirement in § 101.60(c)(1)(i) with respect to sugars content.” This means that a criterion of the health claim is that the food be “sugar free.” As previously discussed, we are amending redesignated § 101.80 (c)(2)(iii)(A) to exempt D-tagatose from the “sugar free” requirement for a food bearing the dental caries health claim. Amended § 101.80 (c)(2)(iii)(A) will read “The food shall meet the requirement in § 101.60(c)(1)(i) with respect to sugars content, except that the food may contain D-tagatose.” As discussed in section V of this document we are taking this action as an alternative to the petitioner's recommendation that D-tagatose be excluded from the “sugars” definition.

We are amending redesignated § 101.80 (c)(2)(iii)(B) to reflect the addition of D-tagatose as a substance eligible for a dental caries health claim. As amended, the section will state “A food whose labeling includes a health claim under this section shall contain one or more of the noncariogenic carbohydrate sweeteners listed in paragraph (c)(2)(ii) of this section.” We also are amending redesignated § 101.80 (c)(2)(iii)(C) to reflect the broadening of the scope of the claim beyond sugar alcohols only. This paragraph now will provide that when carbohydrates other than noncariogenic sweeteners eligible for the claim are present in a food bearing the claim, the food shall not lower plaque pH below 5.7 by bacterial fermentation, as measured by the indwelling plaque test specified in § 101.80 (c)(2)(iii)(C). The address of the Center for Food Safety and Applied Nutrition also has been updated in this paragraph.

The agency is not specifying a qualifying level of D-tagatose in the food product because, like sugar alcohols, D-tagatose will be used as a substitute for fermentable sugars. Therefore, the amount of the substance required is that needed to achieve a desired level of sweetness.

Section 101.80(d) lists the optional information that may be included in the dental caries health claim. We are amending this paragraph to reflect the fact that the claim now includes a noncariogenic carbohydrate sweetener other than sugar alcohols.

Section 101.80 (e) provides model health claims as examples of statements that meet the requirements to make a claim about nonpromotion of dental caries. FDA emphasizes that these model health claims are illustrative only. These model claims illustrate the required, and some of the optional, elements of the interim final rule. Because the agency is authorizing a claim about the relationship between D-tagatose and the nonpromotion of dental caries, and not approving specific claim wording, manufacturers will be free to design their own claim so long as it is consistent with § 101.80(c) and (d).

Current § 101.80 (e)(1) consists of two model claims as examples of the full claim, and § 101.80 (e)(2) consists of two model claims as examples of the shortened claim for use on packages with less than 15-square inches of surface area available for labeling. We are amending § 101.80(e)(1) and (e)(2) to add model claims for D-tagatose. The first example of the full claim states: “Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Tagatose, the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries.” (§ 101.80(e)(1)(iii)). The second example of the full claim states: “Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. Tagatose, the sugar in [name of food], unlike other sugars, does not promote tooth decay.” (§ 101.80(e)(1)(iv)). We are amending § 101.80 (e)(2) by adding two shortened model claims (paragraphs (e)(2)(iii) and (e)(2)(iv)) that read “Tagatose sugar does not promote tooth decay” and “Tagatose sugar may reduce the risk of tooth decay.”

We are issuing this rule as an interim final rule, effective immediately, with an opportunity for public comment. Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final regulation, if the agency determines that such action is necessary for public health reasons. This authority enables us to act promptly on petitions that provide for information that is necessary to: (1) Enable consumers to develop and maintain healthy dietary practices, (2) enable consumers to be informed promptly and effectively of important new knowledge regarding nutritional and health benefits of food, or (3) ensure that scientifically sound nutritional and health information is provided to consumers as soon as possible. Proposed regulations made effective upon publication under this authority are deemed to be final agency action for purposes of judicial review. The legislative history indicates that such regulations should be issued as interim final rules (H. Conf. Rept. No. 105-399, at 98 (1997)).

We are satisfied that all three of the criteria in section 403(r)(7)(A) of the act have been met in the petition submitted by Arla Food Ingredients. This health claim will help enable consumers to develop and maintain healthy dietary practices, such as limiting snacks that contain fermentable sugars. The health claim also will provide consumers with important new knowledge regarding the reduced cariogenic potential of D-tagatose relative to that of other sugars, and will provide consumers with scientifically sound information on the dental health benefits of foods containing D-tagatose . Therefore, we are using the authority given to us in section 403(r)(7)(A) of the act to issue an interim final rule authorizing a health claim for D-tagatose and nonpromotion of dental caries, effective immediately.

FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period. Interested persons may submit to the Dockets Management Branch (see ADDRESSES ) written comments regarding this interim final rule by February 18, 2003. Two copies of any comments are to be submitted, except that individuals may submit one copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

This regulation is effective upon publication in the Federal Register . The agency will address comments and confirm or amend the interim final rule in a final rule.

We have examined the economic implications of this interim final rule as required by Executive Order 12866. 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). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million or more or adversely affecting in a material way a sector of the economy, competition, or jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. We have determined that this interim final rule is not a significant regulatory action as defined by Executive Order 12866.

FDA has identified three options: (1) Deny the petition; (2) add D-tagatose to the dental caries health claim and amend § 101.80(c)(2)(ii)(A), the “Nature of the Food” requirement that the food be “sugar free” except for D-tagatose; or (3) add D-tagatose to the dental caries claim and amend § 101.9(c) to exclude D-tagatose from sugars.

Option one: FDA's denial of the petition would mean no change in the dental caries health claim. Therefore, this option generates no new costs and benefits and is the point of comparison for all other options.

Option two: Option two, the option chosen by the agency, permits foods that contain D-tagatose to bear the dental caries health claim under certain conditions. It will generate social benefits because it provides additional information to consumers who wish to avoid dental caries. Treatment of dental caries creates considerable costs. Dental caries is the most common chronic childhood disease and 94 percent of adults have either untreated decay or fillings in the crowns of their teeth, with an average of 22 affected surfaces, according to the National Oral Health Survey, part of the National Health and Nutrition Examination Survey (Ref. 6). The cost of treating tooth caries includes: The cost of applying an amalgam, maintaining that amalgam for an individual's lifetime, and lost work time for the application of the amalgam. The median life of an amalgam is 9 to 14 years, and so it must be replaced regularly as long as the tooth remains. The estimated average, weighted lifetime cost of a carious surface is 100.62 dollars in 1995 (Ref. 5). This cost estimate includes: The discounted future costs of replacement amalgams and lost work time, and incorporates the incidence of dental caries by age and the age distribution of the U.S. population. With inflation, the cost is 118.37 dollars in 2002. This estimate does not include pain and suffering associated with dental caries, or possible problems associated with failure to treat dental caries, such as tooth losses or root canals. There are a number of risk factors for developing dental caries: Genetic factors, eating behaviors, and types and characteristics of foods eaten (Ref. 4). Specifically, consumption of dietary sugars and starches have been linked to development of dental caries. Substitution of D-tagatose for other sugars in foods, such as gum, candies, and baked goods, can potentially reduce the risk of dental caries. This would lead to benefits in reduced expenditures on dental care, less work time lost for dental visits, and other complications, such as tooth loss.

Option two will not generate any compliance costs relative to option one, because use of the claim is voluntary. No firm will choose to use the claim allowed by this interim rule unless the firm believes that doing so will increase its profits. However, because the interim rule specifies the manner in which a health claim can be made in product labeling, this interim rule imposes restrictions that may lead to greater or smaller social benefits or costs compared with alternative requirements for making the claim. The expected net benefits of option two are positive.

Option 3: Allowing the addition of D-tagatose to the dental caries claim and amending the definition of sugars also would aid consumers in choosing foods that do not promote dental caries. However, D-tagatose is a sugar. Amending the nutrition labeling definition of sugars to exclude D-tagatose would be counter to the commonly understood definition of sugars. To declare D-tagatose not to be a sugar would mislead consumers and undermine the scientific accuracy of the nutritional labeling, which many consumers currently rely on to make healthy food choices. It is not possible to quantify this cost. Amending the definition of sugars to exclude D-tagatose, and therefore, allowing foods containing D-tagatose to be labeled “sugar free,” could potentially generate considerable benefits to the petitioner in its efforts to market D-tagatose. However, these benefits would be offset by the costs of providing invalid information to consumers.

We have examined the economic implications of this interim final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant impact on a substantial number of small entities, the Regulatory Flexibility Act requires the agency to analyze regulatory options that would minimize the economic impact of the rule on small entities.

As previously explained, this interim final rule will not generate any compliance costs for any small entities, because it does not require small entities to undertake any new activity. No small business will choose to use the dental caries health claim authorized by this rule unless it believes that doing so will increase its profits. Accordingly, we certify that this interim final rule will not have a significant impact on a substantial number of small entities. Under the Regulatory Flexibility Act, no further analysis is required.

Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires cost-benefit and other analyses before any rulemaking if the rule would include a “Federal Mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” We have determined that this interim final rule does not constitute a significant regulatory action under the Unfunded Mandates Reform Act.

We have determined under 21 CFR 25.32(p) that the actions resulting from this interim final rule are categorically excluded. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA concludes that the labeling provisions of this interim 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. 3501-3520). Rather, the food labeling health claim on the association between D-tagatose and the nonpromotion of dental caries is 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)).

We have analyzed this interim final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States or on the relationship between the National Government and the States, or on the distribution of power and responsibility among the various levels of government. Accordingly, we have concluded that the interim final rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

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

Section 4022(b) of the Employee Retirement Income Security Act of 1974 provides for certain limitations on benefits guaranteed by the PBGC in terminating single-employer pension plans covered under Title IV of ERISA. One of the limitations, set forth in section 4022(b)(3)(B), is a dollar ceiling on the amount of the monthly benefit that may be paid to a plan participant (in the form of a life annuity beginning at age 65) by the PBGC. The ceiling is equal to “$750 multiplied by a fraction, the numerator of which is the contribution and benefit base (determined under section 230 of the Social Security Act) in effect at the time the plan terminates and the denominator of which is such contribution and benefit base in effect in calendar year 1974 [$13,200].” This formula is also set forth in § 4022.22(b) of the PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022). Appendix D to part 4022 lists, for each year beginning with 1974, the maximum guaranteeable benefit payable by the PBGC to participants in single-employer plans that have terminated in that year.

Section 230(d) of the Social Security Act (42 U.S.C. 430(d)) provides special rules for determining the contribution and benefit base for purposes of ERISA section 4022(b)(3)(B). Each year the Social Security Administration determines, and notifies the PBGC of, the contribution and benefit base to be used by the PBGC under these provisions, and the PBGC publishes an amendment to Appendix D to Part 4022 to add the guarantee limit for the coming year.

The PBGC has been notified by the Social Security Administration that, under section 230 of the Social Security Act, $64,500 is the contribution and benefit base that is to be used to calculate the PBGC maximum guaranteeable benefit for 2003. Accordingly, the formula under section 4022(b)(3)(B) of ERISA and 29 CFR § 4022.22(b) is: $750 multiplied by $64,500/$13,200. Thus, the maximum monthly benefit guaranteeable by the PBGC in 2003 is $3,664.77 per month in the form of a life annuity beginning at age 65. This amendment updates Appendix D to Part 4022 to add this maximum guaranteeable amount for plans that terminate in 2003. (If a benefit is payable in a different form or begins at a different age, the maximum guaranteeable amount is the actuarial equivalent of $3,664.77 per month.)

Section 4011 of ERISA requires plan administrators of certain underfunded plans to provide notice to plan participants and beneficiaries of the plan's funding status and the limits of the PBGC's guarantee. The PBGC's regulation on Disclosure to Participants (29 CFR Part 4011) implements the statutory notice requirement. This rule amends Appendix B to the regulation on Disclosure to Participants by adding information on 2003 maximum guaranteed benefit amounts. Plan administrators may, subject to the requirements of that regulation, include this information in participant notices.

General notice of proposed rulemaking is unnecessary. The maximum guaranteeable benefit is determined according to the formula in section 4022(b)(3)(B) of ERISA, and these amendments make no change in its method of calculation but simply list 2003 maximum guaranteeable benefit amounts for the information of the public.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)).

The PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) sets forth (in subpart B) the methods for valuing plan benefits of terminating single-employer plans covered under title IV of the Employee Retirement Income Security Act of 1974. Under ERISA section 4041(c), guaranteed benefits and benefit liabilities under a plan that is undergoing a distress termination must be valued in accordance with part 4044, subpart B. In addition, when the PBGC terminates an underfunded plan involuntarily pursuant to ERISA section 4042(a), it uses the subpart B valuation rules to determine the amount of the plan's underfunding.

Under § 4044.51(b), early retirement benefits are valued based on the annuity starting date, if a retirement date has been selected, or the expected retirement age, if the annuity starting date is not known on the valuation date. Sections 4044.55 through 4044.57 set forth rules for determining the expected retirement ages for plan participants entitled to early retirement benefits. Appendix D of part 4044 contains tables to be used in determining the expected early retirement ages.

Table I in appendix D (Selection of Retirement Rate Category) is used to determine whether a participant has a low, medium, or high probability of retiring early. The determination is based on the year a participant would reach “unreduced retirement age” ( i.e. , the earlier of the normal retirement age or the age at which an unreduced benefit is first payable) and the participant's monthly benefit at unreduced retirement age. The table applies only to plans with valuation dates in the current year and is updated annually by the PBGC to reflect changes in the cost of living, etc.

Tables II-A, II-B, and II-C (Expected Retirement Ages for Individuals in the Low, Medium, and High Categories respectively) are used to determine the expected retirement age after the probability of early retirement has been determined using Table I. These tables establish, by probability category, the expected retirement age based on both the earliest age a participant could retire under the plan and the unreduced retirement age. This expected retirement age is used to compute the value of the early retirement benefit and, thus, the total value of benefits under the plan.

This document amends appendix D to replace Table I-02 with Table I-03 in order to provide an updated correlation, appropriate for calendar year 2003, between the amount of a participant's benefit and the probability that the participant will elect early retirement. Table I-03 will be used to value benefits in plans with valuation dates during calendar year 2003.

The PBGC has determined that notice of and public comment on this rule are impracticable and contrary to the public interest. Plan administrators need to be able to estimate accurately the value of plan benefits as early as possible before initiating the termination process. For that purpose, if a plan has a valuation date in 2003, the plan administrator needs the updated table being promulgated in this rule. Accordingly, the public interest is best served by issuing this table expeditiously, without an opportunity for notice and comment, to allow as much time as possible to estimate the value of plan benefits with the proper table for plans with valuation dates in early 2003.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this regulation, the Regulatory Flexibility Act of 1980 does not apply (5 U.S.C. 601(2)).

The Department of the Army, Rock Island Arsenal requested a temporary deviation on October 1, 2002 for the operation of the drawbridge to allow the bridge owner time for preventive maintenance. The drawbridge operation regulations found at 33 CFR 117.5, require the drawbridge to open on signal. In order to perform extensive repairs and required annual maintenance, the bridge must be kept inoperative and in the closed to navigation position. This deviation allows the bridge to remain closed to navigation for 57 days starting at 8 a.m., December 28, 2002 and ending at 8 a.m., February 22, 2003. This maintenance period was scheduled during the winter months to lessen the impact on vessel traffic which will increase when Lock 17 reopens on March 1, 2003.

The Rock Island Railroad & Highway Drawbridge provides a vertical clearance of 23.8 feet above normal pool in the closed to navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. The drawbridge will not be able to open for emergencies during the repair period. This deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Burlington Northern Santa Fe Railroad requested a temporary deviation on September 23, 2002 for the operation of the drawbridge to allow the bridge owner time for preventative maintenance. The drawbridge operation regulations found at 33 CFR 117.667(a) require the drawbridge to open on signal if at least 24 hours notice is given from December 15 through March 31. At all other times the bridge is required to open on signal. This deviation allows the bridge to remain closed to navigation, even upon signal, from 8 a.m., November 8, 2002, to 11:59 p.m., December 14, 2002 unless 24 hours advance notice is given. The bridge will open for vessels giving at least 24 hours advance notice.

The Burlington Northern Santa Fe Railroad Drawbridge provides a vertical clearance of 20.4 feet above normal pool in the closed to navigation position. Navigation on the waterway is a mixture of recreational boating and commercial tows. This deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the operating regulations is authorized under 33 CFR 117.35.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On September 27, 2002, the Coast Guard published a temporary deviation from the Drawbridge Operation Regulations (67 FR 60865) entitled Drawbridge Operation Regulations Harlem River, New York. That temporary deviation allowed the bridge to remain closed to navigation from September 23, 2002 through November 20, 2002. The bridge has been in the closed position to navigation since September 23, 2002.

The bridge owner recently advised the Coast Guard that due to inclement weather the completion of the repair work has been delayed and will not be completed until January 19, 2003. The bridge is presently inoperable due to painting scaffolding located at the bridge.

There have been no requests to open the bridge during the time period November through January for several years. The Coast Guard believes this closure is reasonable and notice and public comment are not necessary based upon the need to complete the bridge maintenance and the fact that the bridge has no requests to open.

Any delay encountered in this regulation's effective date would be unnecessary and contrary to the public interest since immediate action is needed to complete this bridge maintenance.

The Wards Island Bridge has a vertical clearance of 55 feet at mean high water and 60 feet at mean low water. The existing regulations are listed at 33 CFR 117.789(c).

The bridge owner, New York City Department of Transportation, asked the Coast Guard to temporarily change the drawbridge operation regulations to allow the bridge to need not open for the passage of vessel traffic from September 23, 2002 through November 20, 2002, to facilitate structural repairs and bridge painting operations. On September 27, 2002, the Coast Guard published a temporary deviation from the Drawbridge operation regulations (67 FR 60865) [CGD01-02-105] entitled Drawbridge Operation Regulations Harlem River, New York.

The Coast Guard was recently notified by the bridge owner that the painting operations at the bridge will not be completed by November 20, 2002, the end of the temporary deviation effective period. They requested to extend the bridge closure from November 21, 2002 through January 19, 2003, to complete their work. The bridge normally has no requests to open November through January. The Coast Guard believes the bridge closure is reasonable due to the need to complete the bridge maintenance and the lack of vessel traffic.

In § 117.789 a new paragraph (h) will be added to allow the 103 Street (Wards Island) Bridge to remain closed to vessel traffic from November 21, 2002 through January 19, 2003.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3), of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).

This conclusion is based on the fact that the bridge has historically had no requests to open during the effective period of this temporary final rule.

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

The Coast Guard certifies under 5 U.S.C. 605(b), that this rule will not have a significant economic impact on a substantial number of small entities. This conclusion is based on the fact that the bridge has historically had no requests to open during the effective period of this temporary final rule.

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

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

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

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

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

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

This final rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e), of Commandant Instruction M16475.1d, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. Publishing a NPRM, which would incorporate a comment period before a final rule could be issued, would be contrary to the public interest since the Captain of the Port of Jacksonville has determined that immediate action is needed to protect the public, ports and waterways of the United States.

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

On September 12, 2001, one day after the September 11 terrorist attacks, the Coast Guard established a temporary rule establishing security zones around tank vessels, passenger vessels, and military pre-positioned ships until October 3, 2001. On October 3, 2001, the Coast Guard published a second temporary rule continuing these zones until June 15, 2002. A third temporary rule continued the zones until November 15, 2002. This fourth temporary rule will continue the zones until January 30, 2003. The Coast Guard published a notice of proposed rulemaking on June 18, 2002 proposing to make these regulations permanent in nature.

On September 12, 2001, one day after the September 11 terrorist attacks, the Coast Guard established a temporary rule establishing security zones around tank vessels, passenger vessels, and military pre-positioned ships until October 3, 2001 (published on September 26, 2001, 66 FR 49104). Following these attacks by well-trained and clandestine terrorists, national security and intelligence officials have warned that future terrorists attacks are likely. As a result, on October 17, 2001, the Coast Guard published a second temporary rule in the Federal Register continuing these zones through 11:59 p.m. June 15, 2002 (66 FR 52689). The third temporary rule continued the zones through noon on November 15, 2002 (67 FR 41339). This fourth temporary rule continues the zones until January 30, 2003 so the Coast Guard can give adequate consideration to the comments received from the notice of proposed rulemaking (67 FR 55184).

This temporary rule creates 100-yard security zones around all tank vessels, cruise ships, and military pre-positioned ships when these vessels enter, depart or moor within the Ports of Jacksonville and Canaveral. No person or vessel may enter these zones without the permission of the Captain of the Port of Jacksonville. These moving security zones are activated when the subject vessels pass the St. Johns River Sea Buoy, at approximate position 30 deg. 23″ 35′ N, 81 deg. 19″ 08′ West, when entering the Port of Jacksonville, or pass Port Canaveral Channel Entrance Buoys # 3 or # 4, at respective approximate positions 28 deg. 22.7′ N, 80 deg. 31.8′ W, and 28 deg. 23.7′ N, 80 deg. 29.2′ W, when entering Port Canaveral. Temporary fixed security zones are established 100 yards around all tank vessels, cruise ships, and military pre-positioned ships docked in the Ports of Jacksonville and Canaveral, Florida.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because small entities may be allowed to enter on a case-by-case basis with the authorization of the Captain of the Port.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

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

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

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

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

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

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

The Coast Guard considered the environmental impact of this rule and concluded under Figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation.

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian tribal governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationships between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes.

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

Chapter 10 of the Copyright Act, 17 U.S.C., places a statutory obligation on manufacturers and importers of digital audio recording devices and media (“DART”) who distribute the products in the United States to submit royalty fees to the Copyright Office. 17 U.S.C. 1003. Distribution of these royalty fees may be made to any interested copyright owner who has filed a claim and (1) whose sound recording was distributed in the form of digital musical recordings or analog musical recordings and (2) whose musical work was distributed in the form of digital musical recordings or analog musical recordings or disseminated to the public in transmissions. 17 U.S.C. 1006.

Section 1007 provides that claims to these royalty fees must be filed “[d]uring the first 2 months of each calendar year” with the Librarian of Congress “in such form and manner as the Librarian of Congress shall prescribe by regulation.” 17 U.S.C. 1007. Part 259 of title 37 of the Code of Federal Regulations sets forth the procedures for the filing of claims to the DART royalty funds. Section 259.5 states that in order for a claim to be considered timely filed with the Copyright Office, the claims either have to be hand delivered to the Office by the last day in February  1 or if sent by mail, received by the Office by the last day in February or bear a January or February United States Postal Service postmark. 37 CFR 259.5(a). Claims received after the last day in February will be accepted as timely filed only upon proof that the claim was placed within the United States Postal Service during the months of January or February. 37 CFR 259.5(e). A January or February postmark of the United States Postal Service on the envelope containing the claim or, if sent by certified mail return receipt requested, on the certified mail receipt constitutes sufficient proof that the claim was timely filed. 2 37 CFR 259.5(e). The regulations do not provide for the filing of DART claims by alternative methods such as on-line submission or facsimile transmission.

Last year, due to severe disruptions in the delivery of mail to the Office caused by threat of possible anthrax contamination, the Copyright Office waived the regulations requiring that claims bear “the original signature of the claimant or of a duly authorized representative of the claimant,” 37 CFR 259.3(b), and prohibiting the filing of by “facsimile transmission,” 37 CFR 259.5(d), for the filing of claims to the DART royalty funds for the year 2001. See 67 FR 5213 (February 5, 2002). While mail delivery to the Office has now resumed, incoming mail continues to be irradiated and diverted to an off-site location for treatment, resulting in delays in its delivery. Consequently, in light of these continuing delays, the Office once again is waiving §§ 259.3(b) and 259.5(d) and allowing the on-line and facsimile submission of DART claims to the 2002 royalty funds. The Office has decided not to allow the filing of claims by electronic mail because lists of joint claimants can now be filed through the Office's website. The alternative methods set forth in this Notice apply only to the filing of DART claims for the 2002 royalties which are due by February 28, 2003, and in no way apply to other filings with the Office.

This Notice covers only the means by which claims may be accepted as timely filed; all other filing requirements, such as the content of claims, remain unchanged, except as noted herein. See 37 CFR part 259.

Claims to the 2002 DART royalty funds may be submitted as follows:

In order to best ensure the timely receipt by the Copyright Office of their DART claims, the Office strongly encourages claimants to personally deliver their claims by 5 p.m. E.S.T. on February 28, 2003, to the Office of the Copyright General Counsel, James Madison Memorial Building, Room 403, First and Independence Avenue, SE., Washington, DC. Private carriers should not be used for such delivery, as packages brought in by private carriers are subject to treatment at the off-site facility before being delivered to the Office and will be deemed untimely and rejected unless the treated package is received by the Office of the Copyright General Counsel by 5 p.m. E.S.T. on February 28, 2003. Thus, claims should be hand delivered by the claimant or a representative of the claimant ( i.e. , the claimant's attorney or a member of the attorney's staff).

Claimants hand delivering their claims should note that they must follow all provisions set forth in 37 CFR part 259.

The Office has devised on-line electronic forms for filing both single and joint DART claims. Claimants will be able to access and complete the forms via the Copyright Office website and may submit the forms electronically as provided in the instructions accompanying the forms. DART forms will be posted on the Office Web site at http://www.copyright.gov/carp/dart/index.html. Claimants filing a joint claim may list each of their joint claimants directly on the Office's on-line joint claim form or may submit the list of joint claimants as a file attachment to the submission page. Lists of joint claimants sent as an attachment must be in a single file in either Adobe Portable Document (“PDF”) format, in Microsoft Word Version 2000 or earlier, in WordPerfect 9 or earlier, or in ASCII text. There will be a browse button on the form that will allow claimants to attach the file containing the list of joint claimants and then to submit the completed form to the Office. The attachment must contain only the list of names of joint claimants. Joint claims with attachments containing information other than the joint claimants' names will be rejected.

The DART forms will be available for use during the months of January and February. It is critically important to follow the instructions in completing the forms before submitting them to the Office. Claims submitted on-line using forms or formats other than those specified in this Notice will not be accepted by the Office. Claims filed on-line must be received by the Office no later than 11:59 p.m. E.S.T. on February 28, 2003. Specifically, the completed electronic forms must be received in the Office's server by that time. Any claim received after that time will be considered as untimely filed. Claimants will receive an electronic mail message in response stating that the Office has received their submission. Therefore, claimants utilizing this filing option are required to provide an e-mail address. Claimants submitting their claims on-line are strongly encouraged to send their claim no later than February 27, 2003, in order to better ensure timely receipt by the Office.

When filing claims on-line, all provisions set forth in 37 CFR part 259 apply except § 259.3(b), which requires the original signature of the claimant or of the claimant's duly authorized representative on the claim. The Office is waiving this provision for this filing period because at this time the Office is not equipped to receive and process electronic signatures.

Claims may be filed with the Office via facsimile transmission and such filings must be sent to (202) 252-3423. Claims filed in this manner must be received in the Office no later than 5 p.m. E.S.T. on February 28, 2003. The fax machine will be disconnected at that time. Claims sent to any other fax number will not be accepted by the Office.

When filing claims via facsimile transmission, claimants must follow all provisions set forth in 37 CFR part 259 with the exception of § 259.5(d), which prohibits the filing of claims by facsimile transmission. The Office is waiving this provision at this time in order to assist claimants in the timely filing of their claims.

Section 259.5(a)(2) directs claimants filing their claims by mail to send the claims to the Copyright Arbitration Royalty Panel, P.O. Box 70977, Southwest Station, Washington, DC 20024. Claimants electing to send their claims by mail are encouraged to send their claims by certified mail return receipt requested, to have the certified mail receipt (PS Form 3800) stamped by the United States Postal Service, and to retain the certified mail receipt in order to provide proof of timely filing, should the claim reach the Office after the last day in February. In the event there is a question as to whether the claim was deposited with the United States Postal Service during the months of January or February, the claimant must produce the certified mail receipt (PS Form 3800) which bears a United States Postal Service postmark, indicating an appropriate date.

Because of delays in mail delivery, claimants are urged not to use the mail as a means of filing their claims to the 2002 DART royalty funds. While the Office is not prohibiting the filing of claims by mail, those who do so assume the risk that their claim will not reach the Office in a timely manner, and/or that the mail, when received by the Office, will be damaged. Claims sent by mail should be addressed in accordance with § 259.5(a)(2), and the Office again strongly encourages the claimant to send the claim by certified mail return receipt requested, to have the certified mail receipt (PS Form 3800) stamped by the United States Postal Service, and to retain the certified mail receipt, as it constitutes the only acceptable proof of timely filing of the claim. Claims dated only with a business meter that are received by the Office after February 28, 2003, will be rejected as being untimely filed.

When filing claims by this method, claimants must follow all provisions set forth in 37 CFR part 259.

The regulations governing the filing of DART claims require “the original signature of the claimant or of a duly authorized representative of the claimant,” 37 CFR 259.3(b), and do not allow claims to be filed by “facsimile transmission,” 37 CFR 259.5(d). This document, however, waives these provisions as set forth herein solely for the purpose of filing claims to the 2002 DART royalties. The Office is not, and indeed cannot, waive the statutory deadline for the filing of DART claims. See, United States v. Locke, 471 U.S. 84, 101 (1985). Thus, claimants are still required to file their claims by February 28, 2003.

Waiver of an agency's rules is “appropriate only if special circumstances warrant a deviation from the general rule and such deviation will serve the public interest.” Northeast Cellular Telephone Company v. FCC, 897 F.2d 1164, 1166 (D.C. Cir. 1990); see also, Wait Radio v. FCC, 418 F.2d 1153 (D.C. Cir. 1969), cert. denied, 409 U.S. 1027 (1972). Under ordinary circumstances, the Office is reluctant to waive its regulations. However, the continuing delays in the delivery of the mail constitutes a special circumstance which has forced the Office to deviate from its usual mail processing procedures. Thus, given the delays in mail delivery, the Office believes that the public interest will best be served by waiving, for this filing period, the requirement that DART claims bear the original signature of the claimant or of a duly authorized representative of the claimant, when, and only when, such claim is filed on-line through the Office's website. See 67 FR at 5214.

The Office cannot waive the statutory deadline set forth in 17 U.S.C. 1007 and accept claims filed after February 28, 2003. See Locke, supra. Therefore, in order to serve the public interest the Office is providing claimants with alternative methods of filing, in addition to those set forth in the regulations, in order to assist them in timely filing their claims. By allowing claims to be filed on-line and by facsimile transmission, the Office is affording to all claimants an equal opportunity to meet the statutory deadline.

The Clean Air Act (CAA) requires all State and local permitting authorities to develop operating permits programs that meet the requirements of title V of the Act, 42 U.S.C. 7661-7661f, and its implementing regulations, 40 CFR part 70. Washington's operating permits program was submitted in response to this directive. EPA granted interim approval to Washington's air operating permits program on November 9, 1994 (59 FR 55813). EPA repromulgated final interim approval of Washington's operating permits program on one issue, along with a notice of correction, on December 8, 1995 (60 FR 62992).

Washington's title V operating permits program is implemented by the Washington Department of Ecology (Ecology), the Washington Energy Facility Site Evaluation Commission (EFSEC), and seven local air pollution control authorities: The Benton Clean Air Authority (BCAA); the Northwest Air Pollution Authority (NWAPA); the Olympic Regional Clean Air Authority (ORCAA); the Puget Sound Clean Air Agency (PSCAA); the Spokane County Air Pollution Control Authority (SCAPCA); the Southwest Clean Air Agency (SWCAA); and the Yakima Regional Clean Air Authority (YRCAA). After these State and local agencies revised their operating permits programs to address the conditions of the interim approval, EPA promulgated final full approval of Washington's title V operating permits program on August 13, 2001 (66 FR 42439).

On May 15, 2002, Ecology proposed revisions to its regulations for insignificant emissions units (IEU), as well as other minor revisions to its title V regulations. The proposed revisions to Ecology's IEU regulations were intended to resolve a deficiency in Washington's title V program identified by EPA in a notice of deficiency published in the Federal Register on January 2, 2002 (67 FR 73). On June 28, 2002, EPA proposed to approve Ecology's proposed revisions to its title V regulations at the same time that Ecology was considering and taking public comment on the proposed changes. See 67 FR 43575. The public comment period on the Ecology regulations ended on June 21, 2002. In response to comments received by Ecology during that public comment process, Ecology made minor changes to its proposed title V revisions. On September 26, 2002, Ecology submitted the final revisions to its title V regulations and asked EPA to give final approval to the revisions.

EPA received no comments on its proposal to approve Ecology's proposed revisions to its title V regulations. EPA has reviewed Ecology's final submittal and has determined that the minor changes made by Ecology in response to public comment at the state level do not change the substance of the regulatory revisions proposed by Ecology and continue to meet the requirements of part 70. Accordingly, EPA is taking final action to approve Ecology's final revisions to its IEU provisions, as well as the other minor revisions to its title V regulations.

The version of WAC 173-401-530 (Ecology's IEU provision) finalized by Ecology is identical to the proposed rule submitted to EPA in May 2002. Ecology did make a minor change to the definition of “continuous compliance,” which is used in the IEU provision as well as elsewhere in Ecology's title V regulations in describing the compliance certification obligations of permittees. The definition of “continuous compliance” proposed by Ecology was identical to the definition in the instructions to the standard annual compliance certification form developed by EPA for use by permittees subject to the Federal operating permits program. See http://www.epa.gov/oar/oaqps/permits/p71forms.html. Under that definition, a permittee could certify continuous compliance if there were no “deviations and no other information that indicates deviations, except for malfunctions or upsets during which compliance is not required.” The final definition adopted by Ecology states that a permittee could certify continuous compliance if there were no “deviations and no other information that indicates deviations, except for unavoidable excess emissions or other operating conditions during which compliance is not required.” Ecology has clarified that nothing in the final definition of “continuous compliance” it adopted was intended to take a position on whether compliance is or is not required during unavoidable excess emissions or other operating conditions. EPA therefore continues to believe that the definition of “continuous compliance” is approvable. As noted by EPA in the proposal and by Ecology during its rulemaking process, however, Ecology would be required to later revise its definition of “continuous compliance” if EPA later adopts a definition of this term after notice and comment rulemaking and Ecology's definition is not consistent with the Federal definition. See 67 FR 43577.

Ecology also added a sentence to the proposed definition of “intermittent compliance,” which is also used in describing the compliance certification obligations of permittees. The added sentence clarifies that a certification of intermittent compliance is appropriate where the monitoring data or other information shows there are periods of noncompliance or periods of time during which monitoring required by the permit was not performed or recorded. EPA finds this definition approvable, subject again to the qualification that if EPA later adopts a definition of “intermittent compliance” after notice and comment rulemaking and if the Ecology definition is not consistent with the Federal definition, Ecology would be required to later revise its definition.

Ecology also made a further change to the definition of “major source” in its final title V revisions. See WAC 173-401-200. In the final rule adopted by Ecology, the definition of “major source” is consistent with EPA's recent amendments to the definition of “major source” in part 70 in all respects. See 66 FR 59161 (November 27, 2001). As originally proposed, the Ecology definition was more stringent than EPA's definition in one respect. See 67 FR 43577. Because the final definition of “major source” adopted by Ecology is consistent with the definition in part 70, EPA continues to believe that Ecology's final change to the definition of “major source” is approvable.

Finally, Ecology made a minor change to its proposed revision to the time for reporting of deviations that do not represent a potential threat to human health or safety. 1 See WAC 173-401-615(3)(b). As proposed, such a deviation was required to be reported no later than 30 days after the end of the month during which the deviation is discovered or as part of routine emission monitoring reports, whichever occurred first. In the final version, the rule requires such deviations to be reported no later than 30 days after the end of the month during which the deviation is discovered. This is still more stringent that the previous version of Ecology's rule which gave permitting authorities the discretion to require reporting of “other deviations” (that is, deviations that do not represent a potential threat to human health or safety) either no later than 30 days after the end of the month during which the deviation is discovered or as part of routine emission monitoring reports. EPA therefore continues to believe that the final rule adopted by Ecology is consistent with the requirements of part 70.

EPA is taking final action to approve as a revision to Ecology's title V air operating permits program revisions to Ecology's regulations for IEUs, specifically, revisions to WAC 173-401-530(2)(c) and the deletion of WAC 173-401-530(2)(d). EPA has determined that these changes meet the requirements of title V and part 70 relating to IEUs, and adequately address the deficiency identified in the notice of deficiency published in the Federal Register on January 2, 2002 (67 FR 73). EPA is also approving the addition of definitions for “continuous compliance” and “intermittent compliance,” the change to the definition of “major source,” changes to clarify that the use of a standard application form is not required if all required information is provided by the applicant, and a change to the time frame for the prompt reporting of permit deviations. Because the revisions chapter 173-401 apply throughout the State of Washington, this approval applies to all State and local agencies that implement Washington's operating permits program. As discussed above, those agencies include Ecology, EFSEC, BCAA, NWAPA, ORCAA, PSCAA, SCAPCA, SWCAA, and YRCAA.

Consistent with EPA's proposal to approve these revisions, this approval does not extend to “Indian Country,” as defined in 18 U.S.C. 1151, except with respect to non-trust lands within the 1873 Survey Area of the Puyallup Reservation. 2 See 66 FR 42439, 42440 (August 13, 2001); 64 FR 8247, 8250-8251 (February 19, 1999); 59 FR 42552, 42554 (August 18, 1994).

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities because it merely approves State law as meeting Federal requirements and imposes no additional requirements beyond those imposed by State law. This rule does not contain any unfunded mandates and does not significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) because it approves pre-existing requirements under State law and does not impose any additional enforceable duties beyond that required by State law. This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have Federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). The rule merely approves existing requirements under State law, and does not alter the relationship or the distribution of power and responsibilities between the State and the Federal government established in the Clean Air Act. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) or Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001), because it is not a significantly regulatory action under Executive Order 12866. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

In reviewing State operating permit programs submitted pursuant to title V of the Clean Air Act, EPA will approve State programs provided that they meet the requirements of the Clean Air Act and EPA's regulations codified at 40 CFR part 70. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a State operating permit program for failure to use VCS. It would, thus, be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of a State program that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 31, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See CAA section 307(b)(2).

FEMA makes the final determinations listed below of the final determinations of modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Administrator, Federal Insurance and Mitigation Administration, has resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this rule includes the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection.

The modifications are made pursuant to Section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR Part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

The changes in BFEs are in accordance with 44 CFR 65.4.

This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

The Administrator, Federal Insurance and Mitigation Administration, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories.

Under the implementing regulations at 50 CFR 635.27(a)(8), NMFS has the authority to transfer quotas among categories, or, as appropriate, subcategories, of the fishery, after considering the following factors: (1) The usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock; (2) the catches of the particular category quota to date and the likelihood of closure of that segment of the fishery if no allocation is made; (3) the projected ability of the vessels fishing under the particular category quota to harvest the additional amount of BFT before the end of the fishing year; (4) the estimated amounts by which quotas established for other gear segments of the fishery might be exceeded; (5) the effects of the transfer on BFT rebuilding and overfishing; and (6) the effects of the transfer on accomplishing the objectives of the HMS FMP.

If it is determined, based on the factors listed here and the probability of exceeding the total quota, that vessels fishing under any category or subcategory quota are not likely to take that quota, NMFS may transfer inseason any portion of the remaining quota of that fishing category to any other fishing category or to the Reserve quota.

Annual BFT quota specifications issued under § 635.27 provide for a quota of 647.0 mt of large medium and giant BFT to be harvested from the regulatory area by vessels fishing under the General category quota during the 2002 fishing year. The General category BFT quota is further subdivided into time period subquotas to provide for broad temporal and geographic distribution of scientific data collection and fishing opportunities. The October-December subquota was initially set at 63.7 mt for the 2002 fishing year, and is currently 271.7 mt, after the addition of approximately 78.0 mt of unharvested subquota from previous periods and a previous quota transfer of 130 mt (67 FR 63854, October 16, 2002). As of November 13, 2002, BFT landings against the adjusted October-December General category subquota have totaled approximately 326.8 mt, exceeding the available coastwide quota by 55.1 mt. An additional 10 mt has been set aside for the traditional fall New York Bight fishery.

After considering the factors for making transfers between categories, NMFS has determined that 10 mt of the remaining adjusted Longline North subcategory quota of approximately 13.3 mt should be transferred to the coastwide General category quota. NMFS has also determined that 15 mt of the remaining Angling school subcategory quota of approximately 195.6 mt (10 mt of the remaining Angling school north subcategory quota of approximately 94.1 mt, and 5 mt of the remaining Angling school south subcategory quota of approximately 57.4 mt), 15 mt of the remaining Harpoon category quota of approximately 36.2 mt, and 65 mt of the remaining Reserve category quota should be transferred to the coastwide General category. Finally, NMFS has determined to transfer the remaining General category New York Bight set-aside subquota of approximately10 mt into the coastwide General category quota. The adjusted subquota for the coastwide General category fishery for the October-December period is 386.7 mt. Landings of large medium or giant BFT in the General category New York Bight set-aside area have been minimal this year and the transfer of the 10 mt set-aside should not adversely impact General category participants in this set-aside area. Vessels participating in General category New York Bight fishery may continue to land and sell large medium or giant BFT against the adjusted coastwide General category quota.

Once the adjusted General category subquota for the October-December period has been attained, the coastwide fishery will be closed. Announcement of the closure will be filed with the Office of the Federal Register , stating the effective date of closure, and further communicated through the HMS Fax Network, the Atlantic Tunas Information Lines, HMS websites, NOAA weather radio, and Coast Guard Notice to Mariners. Although notification of closure will be provided as far in advance as possible, fishermen are encouraged to call the Atlantic Tunas Information Line at (888) USA-TUNA or (978) 281-9305 or access www.nmfspermits.com , to check the status of the fishery before leaving for a fishing trip.

The Assistant Administrator for Fisheries, NOAA (AA), finds for good cause that providing prior notice and public comment, as required under 5 U.S.C. 553 (b)(B), is impracticable and contrary to the public interest. Without immediate effectiveness of these inseason adjustments, NMFS would not be providing U.S. fishermen with a reasonable opportunity to catch the quota that ICCAT allocated to the United States. For this reason, and because the action relieves a restriction in reopening the fishery, the AA also finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553 (d)(1) and (3). This action is undertaken pursuant to 50 CFR 635.27 and is exempt for review under Executive Order 12866.

Regulations governing the scup fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is allocated into three quota periods. The Winter II commercial quota (November through December) is distributed to the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the seasonal allocation is described at § 648.120.

The total commercial quota for scup for the 2002 calendar year was initially set at 8,000,000 lb (3,628,739 kg) and then adjusted downward to 7,834,522 lb (3,553,679 kg), to account for research quota set-asides (66 FR 66351; December 26, 2001). The Winter II period quota, which is equal to 15.94 percent of the annual commercial quota, was 1,248,823 lb (566,456 kg). The 2002 Winter II quota allocation was then adjusted downward to compensate for 2001 Winter II landings in excess of the 2001 Winter II quota (67 FR 49621, July 31, 2002), consistent with the procedures specified at § 648.120(d)(3)(ii). Accordingly, the final adjusted 2002 Winter II period commercial quota is 1,179,502 lb (535,013 kg).

Section 648.121 requires the Administrator, Northeast Region, NMFS (Regional Administrator) to monitor the commercial scup quota for each quota period and, based upon dealer reports, state data, and other available information, to determine when the commercial quota has been harvested. NMFS is required to publish notification in the Federal Register advising and notifying federally permitted commercial vessels and federally permitted dealers that, effective upon a specific date, the scup commercial quota has been harvested. The Regional Administrator has determined, based upon dealer reports and other available information, that the scup commercial quota for the 2002 Winter II period has been harvested.

The regulations at § 648.4(b) provide that Federal scup moratorium permit holders agree, as a condition of the permit, not to land scup in any state after NMFS has published a notification in the Federal Register stating that the commercial quota for the period has been harvested and that no commercial quota for scup is available. Therefore, effective 0001 hours, December 2, 2002, further landings of scup by vessels holding Federal scup moratorium permits are prohibited through December 31, 2002. The 2003 Winter I period for commercial scup harvest will open on January 1, 2003. Effective 0001 hours, December 2, 2002, federally permitted dealers are also advised that they may not purchase scup from federally permitted vessels that land in coastal states from Maine through North Carolina for the remainder of the Winter II period (through December 31, 2002).

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

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

The A season apportionment of the 2002 Pacific cod TAC allocated to catcher processor vessels using hook-and-line gear in the BSAI was established by an emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002) and by two reallocations of Pacific cod (67 FR 61826, October 2, 2002 and 67 FR 70557 November 25, 2002) as a directed fishing allowance of 89,920 metric tons. See § 679.20(c)(3)(iii), § 679.20(c)(5), and § 679.20(a)(7)(i)(A)&(C).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2002 Pacific cod TAC allocated to catcher processor vessels using hook-and-line gear as a directed fishing allowance in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher processor vessels using hook-and-line gear in the BSAI.

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to prevent exceeding the 2002 Pacific cod TAC allocated to catcher processor vessels using hook-and-line gear constitutes good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(3)(B) and 679.20(b)(3)(iii)(A), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion to prevent exceeding the 2002 Pacific cod TAC allocated to catcher processor vessels using hook-and-line gear constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

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