Rules and Regulations. Final rule

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BILLING CODE 4910-13-M DEPARTMENT OF STATE 22 CFR Part 62 [Public Notice: 5981] RIN 1400-AC29 Exchange Visitor Program—Sanctions and Terminations AGENCY: Department of State. ACTION: Final rule. SUMMARY: The Department is amending its regulations to add to and modify the existing actions for which the Department may sanction a sponsor. The change in the regulations will streamline the review process to offer sanctioned sponsors the procedural due process rights equal to those that the Administrative Procedure Act guarantees.

In addition, the Final Rule eliminates summary suspension and modifies program suspension to halt the activities of a sponsor that has committed a serious act of omission or commission which has or could have the effect of endangering the health, safety, or welfare of an exchange visitor, or damage the national security interests of the United States. DATES: *Effective Date:* This Final Rule is effective 30 days from November 2, 2007. SUPPLEMENTARY INFORMATION: The former United States Information Agency

(USIA)and, as of October 1, 1999, its successor, the U.S. Department of State (Department), have promulgated regulations governing the Exchange Visitor Program. Those regulations now appear at 22 CFR Part 62. The regulations governing sanctions appear at 22 CFR 62.50, and regulations governing termination of a sponsor's designation, at 22 CFR 62.60 through 62.62. The ultimate goals of the sanctions regulations are to further the foreign policy interests of the United States, and to protect the health, safety, and welfare of Exchange Visitor Program participants. These regulations largely have remained unchanged since 1993, when the USIA undertook a major regulatory reform of the Exchange Visitor Program, as administered by the Office of Exchange Coordination and Designation (Office). On May 31, 2007, the Department published a Proposed Rule on sanctions and terminations with a comment period ending July 30, 2007. 72 FR 30302-30308. Forty-nine

(49)parties filed comments, which the Department reviewed and evaluated. The Alliance for International Educational and Cultural Exchange (Alliance), a membership organization, and the Council on International Educational Exchange

(CIEE)represented a number of individual designated program sponsors in their comments. Twenty-five

(25)commenting parties favored the Proposed Rule. The remaining commenting parties criticized the Proposed Rule in one or more respects, and several parties recommended changes to the Proposed Rule. Having thoroughly reviewed the comments and the changes that commenting parties recommended, the Department has determined that it will, and hereby does, adopt the Proposed Rule, with minor edits, and promulgates it as a Final Rule. The Department's evaluation of the written comments and recommendations follows. As the Department noted in the Supplementary Information accompanying the Proposed Rule, The [Fulbright-Hays] Act authorizes the President to provide for such exchanges if it would strengthen international cooperative relations. The language of the Act and its legislative history make it clear that the Congress considered international educational and cultural exchanges to be a significant part of the public diplomacy efforts of the President in connection with Constitutional prerogatives in conducting foreign affairs. Thus, exchange visitor programs that do not further the public diplomacy goals of the United States should not be designated initially, or retain their designation. Accordingly, it is imperative that the Department have the power to revoke program designations or deny applications for program redesignation when it determines that such programs do not serve the country's public diplomacy goals. The above statement is the underpinning for the Department's entire approach to the sanctions regime of the Exchange Visitor Program. Comment Analysis One of the overall criticisms of the Proposed Rule was that the Department eliminated the requirement that it find alleged violations of Part 62 to be willful or negligent before imposing sanctions. Fifteen

(15)comments were opposed to the change. The Department believes that such criticism is without merit. A program sponsor, prior to being designated or redesignated, must demonstrate that it (i.e., the responsible officer and alternate responsible officer(s)), its employees, and third parties acting on its behalf have the knowledge and ability to comply and remain in continual compliance with all provisions of part 62. [§ 62.3(b)(1); § 62.9(a) and (f)(1) and (2); and § 62.11(a).] Since knowledge and ability to comply and remain in full compliance with the regulations are fundamental requirements of sponsor designation, it is essentially irrelevant whether a sponsor violates regulations willfully, negligently, or even inadvertently. Violations, whether or not willful or negligent, may harm the national security or the public diplomacy goals of the United States, or pose a threat to the health, safety or welfare of program participants, and the Department must have the capacity to respond appropriately. Moreover, the process set forth in the revised sanctions regulations provides that a sponsor being sanctioned may submit a statement in opposition to or mitigation of the proposed sanction. This process provides the sponsor with the opportunity to explain the circumstances of the alleged violation, and to argue that a lesser sanction, or no sanction at all, would be appropriate in view of those circumstances. In addition, the review process available for significant sanctions provides a second opportunity for the sponsor to make its case before a panel of three Review Officers not connected with the Exchange Visitor Program, thus affording additional protection from the arbitrary or capricious imposition of sanctions. A total of sixteen

(16)comments were in favor of the change. Twelve

(12)commenting parties opined that the criteria for imposing sanctions are extremely broad and do not provide an adequate basis for the Department to determine, for example, under what circumstances it would propose to terminate rather than suspend a sponsor's designation or impose lesser sanctions. It should be noted in this regard that four of the six grounds for imposing sanctions are the same as those in the prior rule. The two new grounds—actions that may compromise the national security of the United States or undermine its foreign policy objectives—are of a nature that inherently requires broad discretion in the choice of appropriate sanctions. Moreover, as previously noted, the process for imposing and reviewing proposed sanctions affords a sponsor ample opportunity to argue that alternative sanctions would be more appropriate. Nineteen

(19)of the commenting parties criticized the lack of an agency review process for the “lesser sanctions,” in which the decision of the Office is the final Department decision. [§ 62.50(b)] One

(1)comment was in favor. However, the lack of a review process for “lesser sanctions” is unchanged from the prior rule. Under the prior rule, reduction in the size of a sponsor's program was deemed a “lesser sanction” (and thus not subject to further agency review) if it was limited to a reduction in participants of 10 percent or less or, in the case of a geographical reduction, if it would not cause a significant financial burden for the sponsor. The only change in the Proposed Rule was an increase in the potential size of the reduction, from 10 to 15 percent, and the reminder that subsequent 10-percent reductions may be imposed in the case of continued violations (a possibility that was inherent in the prior rule). The reason for the more limited process for “lesser sanctions” remains the same as in the prior rule: their relatively minor impact on sponsors does not justify the burden and expense, for both the Department and sponsors, of the more extensive process afforded for more significant sanctions. The modest increase of 5 percent in the size of a potential program reduction does not, in the Department's view, alter this rationale. Fourteen

(14)commenting parties criticized the bases for and the process by which the Department will implement a suspension. The prior rule allowed for “suspension” and “summary suspension.” In practice, the Department never utilized the suspension provision of the regulations, and that provision is eliminated in the Final Rule, which redesignates “summary suspension” as “suspension.” Under the prior rule, only one ground for this sanction existed: endangering the health, safety or welfare of a participant. The Final Rule adds another ground, the necessity of which became apparent after the events of 9/11: Damaging the national security interests of the United States. The Department believes that the continued necessity for it to be able to act swiftly, and with immediate effect, in such circumstances is self-evident. Moreover, it should be noted that the summary process for such suspensions has been improved for sponsors in two respects. First, a sponsor is afforded additional time in which to submit an initial opposition to the suspension. Second, such an opposition is received, reviewed and decided at a higher level, by the Principal Deputy Assistant Secretary for Educational and Cultural Affairs

(PDAS)rather than by the Office. As under the prior rule, the sponsor may seek further agency review of this decision, by a three-member review panel. Thirteen

(13)of the commenting parties criticized new language providing that the Department may determine that a class of designated programs compromises the national security of the United States or no longer furthers the public diplomacy mission of the United States [§ 62.62]. Three

(3)comments were in favor of this regulation. If the Department makes such a determination, it may revoke the designations, or deny applications for redesignation, of sponsors of that class of exchange visitor programs. As the Department noted in the Supplementary Information accompanying the Proposed Rule, the Exchange Visitor Program is part of the Department's public diplomacy efforts in furtherance of the President's Constitutional prerogatives in conducting foreign affairs. Accordingly, the Department noted, termination of a program category because it no longer furthers the Department's public diplomacy mission, or compromises national security, has always been inherently within the discretion of the Department. Following 9/11, the Department concluded that its regulations should make that authority, and the means by which it would be exercised, explicit. Thirteen

(13)of the commenting parties opposed the elimination of a trial-type hearing in appeals of significant sanctions. Moreover, those same parties opine that the criteria for imposing a suspension are more stringent than the criteria for revoking a designation or denying an application for redesignation of a program. It is entirely appropriate that the grounds for the suspension sanction be drawn far more narrowly than those for the other significant sanctions. Suspension represents a rapid response to an urgent problem, with expedited procedures including the possibility of an immediately effective sanction, not stayed by any opposition or request for review. In this, it is unlike any other sanction. That is why it is reserved for violations whose seriousness justifies it: Cases in which national security is compromised, or in which a danger is posed to the health, safety or welfare of participants. It would be inappropriate to apply its procedures to other violations; and it would be equally inappropriate to restrict the availability of other sanctions to its narrow grounds. With regard to the elimination of trial-type review procedures for significant sanctions, the Department has found that such procedures are costly, time-consuming and burdensome for both the Department and sponsors. As noted in the Supplementary Information accompanying the Proposed Rule, such procedures are not required by any applicable statute, and are not necessary to afford due process. Under the Final Rule, sponsors are afforded notice and ample, repeated opportunities to be heard. When the Office proposes a significant sanction, a sponsor may submit to the PDAS an opposition, including factual and legal arguments and additional documentary material, such as affidavits and other evidence. Following a statement in response by the Office, the PDAS issues a written, reasoned decision confirming, withdrawing or modifying the sanction. The sponsor may then seek review of the PDAS decision, before a three-member panel, no member of which may be from the Bureau of Educational and Cultural Affairs (of which the Office forms a part, and which is supervised by the PDAS). Once again, the sponsor has the opportunity to file a statement setting forth arguments of fact and law, accompanied by documentary evidence and other attachments. Following a statement in response by the PDAS, the review panel may, at its discretion, convene a brief meeting with the parties, solely for the purpose of clarifying the written submissions. Then the review panel issues a written, reasoned decision confirming, withdrawing or modifying the sanction. This procedure affords ample notice and opportunity to be heard, with a reasoned decision on a clear record. If the program sponsor is not satisfied with the decision ultimately reached by the Review Officers, it continues to have the same opportunities as before to seek relief in an appropriate court. Finally, ten

(10)of the commenting parties requested that sponsors be given the opportunity to cure alleged violations before the Department imposes sanctions. The Department believes that if it were to provide sponsors in all cases the automatic right to cure an alleged violation or deficiency with no risk that an actual sanction will be imposed, then the deterrent effect of the sanctions regime effectively would be eliminated. However, as a practical matter, the Office seldom proposes formal sanctions without first engaging in informal discussions seeking to bring the sponsor into voluntary compliance. Moreover, although there is no right to cure, a sponsor facing the imposition of sanctions certainly may offer a settlement or, in submitting its statement in opposition to or mitigation of the sanction, show it has cured the alleged violations and argue for a less severe sanction, or no sanction at all, and may request a meeting to present its views. Seven

(7)comments favored, and two opposed, the paper review set forth at § 62.50(f). The comments stated that a review should also include statements and information provided by exchange visitor participants, concerned citizens, and school officials. Thirteen

(13)comments were received in favor of a sponsor's not being able to reapply for designation for a minimum of five

(5)years once a designation has been revoked. For the foregoing reasons, the Department is promulgating the Proposed Rule as a Final Rule. Regulatory Analysis Administrative Procedure Act, Unfunded Mandates Reform Act of 1995, and Small Business Regulatory Enforcement Fairness Act of 1996 The Department has determined that this Final Rule involves a foreign affairs function of the United States and is consequently exempt from the procedures required by 5 U.S.C. 553 pursuant to 5 U.S.C. 553(a)(1). Section 202 of the Unfunded Mandates Reform Act of 1995 (UFMA), Public Law 104-4, 109 Stat. 48, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small businesses. The Final Rule has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996. It will not have a substantial effect on the States, 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 has been determined that the Final Rule does not have sufficient federalism implications to warrant application of the consultation provisions of Executive Orders 12372 and 13132. Regulatory Flexibility Act/Executive Order 13272: Small Business Since this rulemaking is exempt from 5 U.S.C. 553 and no other law required the Department to give notice of proposed rulemaking, this rulemaking also is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) or Executive Order 13272, § 3(b). Nonetheless, the Department has analyzed the provisions of the Final Rule and certifies that it will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Executive Order 12866, as Amended The Department does not consider this Final Rule to be a “significant regulatory action” under Executive Order 12866, as amended, § 3(f), Regulatory Planning and Review. In addition, the Department is exempt from Executive Order 12866 except to the extent that it is promulgating, in conjunction with a domestic agency, regulations that are significant regulatory actions. The Department has, nevertheless, reviewed the Final Rule to ensure its consistency with the regulatory philosophy and principles set forth in that Executive Order. Executive Order 12988 The Department has reviewed this Final Rule in light of §§ 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. Executive Orders 12372 and 13132 This Final 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 § 6 of Executive Order 13132, it is determined that this Rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this regulation. Paperwork Reduction Act This Final Rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. List of Subjects in 22 CFR Part 62 Cultural Exchange Programs. Accordingly, 22 CFR part 62 is amended as follows: PART 62—EXCHANGE VISITOR PROGRAM 1. The Authority citation for part 62 is amended as follows: Authority: 8 U.S.C. 1101(a)(15)(J), 1182, 1184, 1258; 22 U.S.C. 1431-1442, 2451-2460; Foreign Affairs Reform and Restructuring Act of 1998, Pub. L. 105-277, Div. G, 112 Stat. 2681-761 *et seq.* ; Reorganization Plan No. 2 of 1977, 3 CFR, 1977 Comp. p. 200; E.O. 12048 of March 27, 1978; 3 CFR, 1978 Comp. p. 168; the Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA) of 1996, Pub. L. 104-208, Div. C, 110 Stat. 3009-546, as amended; Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT ACT), Pub. L. 107-56, Sec. 416, 115 Stat. 354; and the Enhanced Border Security and Visa Entry Reform Act of 2002, Pub. L. 107-173, 116 Stat. 543. 2. Section 62.50 is revised to read as follows: § 62.50 Sanctions.

(a)*Reasons for sanctions.* The Department of State (Department) may impose sanctions against a sponsor upon a finding by its Office of Exchange Coordination and Designation (Office) that the sponsor has:

(1)Violated one or more provisions of this Part;

(2)Evidenced a pattern of failure to comply with one or more provisions of this Part;

(3)Committed an act of omission or commission, which has or could have the effect of endangering the health, safety, or welfare of an exchange visitor; or

(4)Otherwise conducted its program in such a way as to undermine the foreign policy objectives of the United States, compromise the national security interests of the United States, or bring the Department or the Exchange Visitor Program into notoriety or disrepute.

(b)*Lesser sanctions.*

(1)In order to ensure full compliance with the regulations in this Part, the Department, in its discretion and depending on the nature and seriousness of the violation, may impose any or all of the following sanctions ( “lesser sanctions”) on a sponsor upon a finding that the sponsor engaged in any of the acts or omissions set forth in § 62.50(a):

(i)A written reprimand to the sponsor, with a warning that repeated or persistent violations of the regulations in this Part may result in suspension or revocation of the sponsor's Exchange Visitor Program designation, or other sanctions as set forth herein;

(ii)A declaration placing the exchange visitor sponsor's program on probation, for a period of time determined by the Department in its discretion, signifying a pattern of violation of regulations such that further violations could lead to suspension or revocation of the sponsor's Exchange Visitor Program designation, or other sanctions as set forth herein;

(iii)A corrective action plan designed to cure the sponsor's violations; or

(iv)Up to a 15 percent (15%) reduction in the authorized number of exchange visitors in the sponsor's program or in the geographic area of its recruitment or activity. If the sponsor continues to violate the regulations in this Part, the Department may impose subsequent additional reductions, in ten-percent (10%) increments, in the authorized number of exchange visitors in the sponsor's program or in the geographic area of its recruitment or activity.

(2)Within ten

(10)days after service of the written notice to the sponsor imposing any of the sanctions set forth in § 62.50(b)(1), the sponsor may submit to the Office a statement in opposition to or mitigation of the sanction. Such statement may not exceed 20 pages in length, double-spaced and, if appropriate, may include additional documentary material. Sponsors shall include with all documentary material an index of the documents and a summary of the relevance of each document presented. Upon review and consideration of such submission, the Office may, in its discretion, modify, withdraw, or confirm such sanction. All materials the sponsor submits will become a part of the sponsor's file with the Office.

(3)The decision of the Office is the final Department decision with regard to lesser sanctions in § 62.50(b)(1)(i)-(iv).

(c)*Suspension.*

(1)Upon a finding that a sponsor has committed a serious act of omission or commission which has or could have the effect of endangering the health, safety, or welfare of an exchange visitor, or of damaging the national security interests of the United States, the Office may serve the sponsor with written notice of its decision to suspend the designation of the sponsor's program for a period not to exceed one hundred twenty

(120)days. Such notice must specify the grounds for the sanction and the effective date thereof, advise the sponsor of its right to oppose the suspension, and identify the procedures for submitting a statement of opposition thereto. Suspension under this paragraph need not be preceded by the imposition of any other sanction or notice. (2)(i) Within five

(5)days after service of such notice, the sponsor may submit to the Principal Deputy Assistant Secretary for Educational and Cultural Affairs (Principal Deputy Assistant Secretary, or PDAS) a statement in opposition to the Office's decision. Such statement may not exceed 20 pages in length, double-spaced and, if appropriate, may include additional documentary material. A sponsor shall include with all documentary material an index of the documents and a summary of the relevance of each document presented. The submission of a statement in opposition to the Office's decision will not serve to stay the effective date of the suspension.

(ii)Within five

(5)days after receipt of, and upon consideration of, such opposition, the Principal Deputy Assistant Secretary shall confirm, modify, or withdraw the suspension by serving the sponsor with a written decision. Such decision must specify the grounds therefore, and advise the sponsor of the procedures for requesting review of the decision.

(iii)All materials the sponsor submits will become a part of the sponsor's file with the Office.

(3)The procedures for review of the decision of the Principal Deputy Assistant Secretary are set forth in §§ 62.50(d)(3) and (4), (g), and (h), except that the submission of a request for review will not serve to stay the suspension.

(d)*Revocation of designation.*

(1)Upon a finding of any act or omission set forth at § 62.50(a), the Office may serve a sponsor with not less than thirty

(30)days' written notice of its intent to revoke the sponsor's Exchange Visitor Program designation. Such notice must specify the grounds for the proposed sanction and its effective date, advise the sponsor of its right to oppose the proposed sanction, and identify the procedures for submitting a statement of opposition thereto. Revocation of designation under this paragraph need not be preceded by the imposition of any other sanction or notice. (2)(i) Within ten

(10)days after service of such written notice of intent to revoke designation, the sponsor may submit to the Principal Deputy Assistant Secretary a statement in opposition to or mitigation of the proposed sanction, which may include a request for a meeting.

(ii)The submission of such statement will serve to stay the effective date of the proposed sanction pending the decision of the Principal Deputy Assistant Secretary.

(iii)The Principal Deputy Assistant Secretary shall provide a copy of the statement in opposition to or mitigation of the proposed sanction to the Office. The Office shall submit a statement in response, and shall provide the sponsor with a copy thereof.

(iv)A statement in opposition to or mitigation of the proposed sanction, or statement in response thereto, may not exceed 25 pages in length, double-spaced and, if appropriate, may include additional documentary material. Any additional documentary material may include an index of the documents and a summary of the relevance of each document presented.

(v)Upon consideration of such statements, the Principal Deputy Assistant Secretary shall modify, withdraw, or confirm the proposed sanction by serving the sponsor with a written decision. Such decision shall specify the grounds therefor, identify its effective date, advise the sponsor of its right to request a review, and identify the procedures for requesting such review.

(vi)All materials the sponsor submits will become a part of the sponsor's file with the Office.

(3)Within ten

(10)days after service of such written notice of the decision of the Principal Deputy Assistant Secretary, the sponsor may submit a request for review with the Principal Deputy Assistant Secretary. The submission of such request for review will serve to stay the effective date of the decision pending the outcome of the review.

(4)Within ten

(10)days after receipt of such request for review, the Department shall designate a panel of three Review Officers pursuant to § 62.50(g), and the Principal Deputy Assistant Secretary shall forward to each panel member all notices, statements, and decisions submitted or provided pursuant to the preceding paragraphs of § 62.50(d). Thereafter, the review will be conducted pursuant to § 62.50(g) and (h).

(e)*Denial of application for redesignation.* Upon a finding of any act or omission set forth at § 62.50(a), the Office may serve a sponsor with not less than thirty

(30)days' written notice of its intent to deny the sponsor's application for redesignation. Such notice must specify the grounds for the proposed sanction and its effective date, advise the sponsor of its right to oppose the proposed sanction, and identify the procedures for submitting a statement of opposition thereto. Denial of redesignation under this section need not be preceded by the imposition of any other sanction or notice. The procedures for opposing a proposed denial of redesignation are set forth in § 62.50(d)(2), (d)(3), (d)(4), (g), and (h).

(f)*Responsible officers.* The Office may direct a sponsor to suspend or revoke the appointment of a responsible officer or alternate responsible officer for any of the reasons set forth in § 62.50(a). The procedures for suspending or revoking a responsible officer or alternate responsible officer are set forth at § 62.50(d), (g), and (h).

(g)*Review officers.* A panel of three Review Officers shall hear a sponsor's request for review pursuant to § 62.50(c), (d), (e), and (f). The Under Secretary of State for Public Diplomacy and Public Affairs shall designate one senior official from an office reporting to him/her, other than from the Bureau of Educational and Cultural Affairs, as a member of the Panel. The Assistant Secretary of State for Consular Affairs and the Legal Adviser shall each designate one senior official from their bureaus as members of the Panel.

(h)*Review.* The Review Officers may affirm, modify, or reverse the sanction imposed by the Principal Deputy Assistant Secretary. The following procedures shall apply to the review:

(1)Upon its designation, the panel of Review Officers shall promptly notify the Principal Deputy Assistant Secretary and the sponsor in writing of the identity of the Review Officers and the address to which all communications with the Review Officers shall be directed.

(2)Within fifteen

(15)days after service of such notice, the sponsor may submit to the Review Officers four

(4)copies of a statement identifying the grounds on which the sponsor asserts that the decision of the Principal Deputy Assistant Secretary should be reversed or modified. Any such statement may not exceed 25 pages in length, double-spaced; and any attachments thereto shall not exceed 50 pages. A sponsor shall include with all attachments an index of the documents and a summary of the relevance of each document presented. The Review Officers shall transmit one

(1)copy of any such statement to the Principal Deputy Assistant Secretary, who shall, within fifteen

(15)days after receipt of such statement, submit four

(4)copies of a statement in response. Any such statement may not exceed 25 pages in length, double-spaced; and any attachments thereto shall not exceed 50 pages. The Principal Deputy Assistant Secretary shall include with all attachments an index of the documents and a summary of the relevance of each document presented. The Review Officers shall transmit one

(1)copy of any such statement to the sponsor. No other submissions may be made unless specifically authorized by the Review Officers.

(3)If the Review Officers determine, in their sole discretion, that a meeting for the purpose of clarification of the written submissions should be held, they shall schedule a meeting to be held within twenty

(20)days after the receipt of the last written submission. The meeting will be limited to no more than two

(2)hours. The purpose of the meeting will be limited to the clarification of the written submissions. No transcript may be taken and no evidence, either through documents or by witnesses, will be received. The sponsor and the representative of the Principal Deputy Assistant Secretary may attend the meeting on their own behalf and may be accompanied by counsel.

(4)Following the conclusion of the meeting, or the submission of the last written submission if no meeting is held, the Review Officers shall promptly review the submissions of the sponsor and the Principal Deputy Assistant Secretary, and shall issue a signed written decision within thirty

(30)days, stating the basis for their decision. A copy of the decision will be delivered to the Principal Deputy Assistant Secretary and the sponsor.

(5)If the Review Officers decide to affirm or modify the sanction, a copy of their decision shall also be delivered to the Department of Homeland Security and to the Bureau of Consular Affairs of the Department of State. The Office, at its discretion, may further distribute the decision.

(6)Unless otherwise indicated, the sanction, if affirmed or modified, is effective as of the date of the Review Officers' written decision, except in the case of suspension of program designation, which is effective as of the date specified pursuant to § 62.50(c).

(i)*Effect of suspension, revocation, or denial of redesignation.* A sponsor against which an order of suspension, revocation, or denial of redesignation has become effective may not thereafter issue any Certificate of Eligibility for Exchange Visitor (J-1) Status (Form DS-2019) or advertise, recruit for, or otherwise promote its program. Under no circumstances shall the sponsor facilitate the entry of an exchange visitor into the United States. An order of suspension, revocation, or denial of redesignation will not in any way diminish or restrict the sponsor's legal or financial responsibilities to existing program applicants or participants.

(j)*Miscellaneous—*

(1)*Computation of time.* In computing any period of time prescribed or allowed by these regulations, the day of the act or event from which the designated period of time begins to run is not included. The last day of the period so computed is included unless it is a Saturday, a Sunday, or a Federal legal holiday, in which event the period runs until the end of the next day which is not one of the aforementioned days. When the period of time prescribed or allowed is fewer than eleven

(11)days, intermediate Saturdays, Sundays, or Federal legal holidays are excluded in the computation.

(2)*Service of notice to sponsor.* Service of notice to a sponsor pursuant to this section may be accomplished through written notice by mail, delivery, or facsimile, upon the president, chief executive officer, managing director, General Counsel, responsible officer, or alternate responsible officer of the sponsor. 3. Subpart E is revised to read as follows: Subpart E—Termination and Revocation of Programs Sec. 62.60 Termination of designation. 62.61 Revocation. 62.62 Termination of, or denial of redesignation for, a class of designated programs. 62.63 Responsibilities of the sponsor upon termination or revocation. § 62.60 Termination of designation. Designation will be terminated upon the occurrence of any of the circumstances set forth in this section.

(a)*Voluntary termination.* A sponsor notifies the Department of its intent to terminate its designation voluntarily and withdraws its program in SEVIS via submission of a “cancel program” request. The sponsor's designation shall terminate upon submission of such notification. Such sponsor may apply for a new program designation.

(b)*Inactivity.* A sponsor fails to comply with the minimum program size or duration requirements, as specified in § 62.8

(a)and (b), in any 12-month period. Such sponsor may apply for a new program designation.

(c)*Failure to file annual reports.* A sponsor fails to file annual reports for two

(2)consecutive years. Such sponsor is eligible to apply for a new program designation.

(d)*Failure to file an annual management audit.* A sponsor fails to file an annual management audit, if such audits are required in the relevant program category. Such sponsor is eligible to apply for a new program designation upon the filing of the past due management audit.

(e)*Change in ownership or control.* An exchange visitor program designation is not assignable or transferable. A major change in ownership or control automatically terminates the designation. However, the successor sponsor may apply for designation of the new entity, and it may continue to administer the exchange visitor activities of the previously-designated program while the application for designation is pending before the Department of State:

(1)With respect to a for-profit corporation, a major change in ownership or control is deemed to have occurred when one third (33.33%) or more of its stock is sold or otherwise transferred within a 12-month period;

(2)With respect to a not-for-profit corporation, a major change of control is deemed to have occurred when 51 percent (51%) or more of the board of trustees or other like body, vested with its management, is replaced within a 12-month period.

(f)*Non-compliance with other requirements.* A sponsor fails to remain in compliance with Federal, State, local, or professional requirements necessary to carry out the activity for which it is designated, including loss of accreditation, or licensure.

(g)*Failure to apply for redesignation.* A sponsor fails to apply for redesignation, pursuant to the terms and conditions of § 62.7, prior to the conclusion of its current designation period. If so terminated, the former sponsor may apply for a new program designation, but the program activity will be suspended during the pendency of the application. § 62.61 Revocation. The Department may terminate a sponsor's program designation by revocation for cause as specified in § 62.50. Such sponsor may not apply for a new designation for five

(5)years following the effective date of the revocation. § 62.62 Termination of, or denial of redesignation for, a class of designated programs. The Department may, in its sole discretion, determine that a class of designated programs compromises the national security of the United States or no longer furthers the public diplomacy mission of the Department of State. Upon such a determination, the Office shall:

(a)Give all sponsors of such class of designated programs not less than thirty

(30)days' written notice of the revocation of Exchange Visitor Program designations for such programs, specifying therein the grounds and effective date for such revocations; or

(b)Give any sponsor of such class of designated programs not less than thirty

(30)days' written notice of its denial of the sponsor's application for redesignation, specifying therein the grounds for such denial and effective date of such denial. Revocation of designation or denial of redesignation on the above-specified grounds for a class of designated programs is the final decision of the Department. § 62.63 Responsibilities of the sponsor upon termination or revocation. Upon termination or revocation of its program designation, a sponsor must:

(a)Fulfill its responsibilities to all exchange visitors who are in the United States at the time of the termination or revocation; and

(b)Notify exchange visitors who have not entered the United States that the program has been terminated or revoked, unless a transfer to another designated program can be obtained. Dated: October 22, 2007. Stanley S. Colvin, Director, Office of Exchange Coordination and Designation, Bureau of Educational and Cultural Affairs, Department of State. [FR Doc. E7-21522 Filed 11-1-07; 8:45 am] BILLING CODE 4710-05-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD05-07-088] RIN 1625-AA00 Safety Zone: Holiday Flotilla Fireworks Display, Motts Channel/ Banks Channel, Wrightsville Beach, NC AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard proposes the establishment of a 1,000 foot safety zone around a fireworks display for the North Carolina Holiday Flotilla occurring on November 24, 2007, on Motts Channel/ Banks Channel, Wrightsville Beach, NC. This action is intended to restrict vessel traffic on Motts Channel. This safety zone is necessary to protect mariners from the hazards associated with fireworks displays. DATES: This rule will be effective from 6 p.m. to 8 p.m. on November 24, 2007. ADDRESSES: You may mail comments and related material to Commander, Sector North Carolina, 2301 East Fort Macon Road, Atlantic Beach, NC 28512. Sector North Carolina maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at the Federal Building Fifth Coast Guard District between 9 a.m. and 2 p.m., Monday through Friday, except Federal Holidays. FOR FURTHER INFORMATION CONTACT: Chief Todd C. Mann, Marine Environmental Response Branch, Coast Guard Marine Safety Unit Wilmington, North Carolina at

(910)772-2216. SUPPLEMENTARY INFORMATION: Regulatory Information A Notice of Proposed Rulemaking Holiday Flotilla Fireworks Display, Motts Channel/Banks Channel, Wrightsville Beach, North Carolina was published on September 14, 2007 for review in the **Federal Register** . (72 FR 52534). We received no comments on the proposed rule. No public hearing was requested, and none was held. Under 5 U.S.C. 553(d)(3), the Coast Guard finds good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . This safety zone is a necessary measure to help the community safely enjoy a holiday fireworks display. It is in the public interest to protect mariners from the hazards associate with fireworks displays and for this reason the Coast Guard is taking the necessary preventative measure of establishing this zone. Background and Purpose On November 24, 2007, the North Carolina Holiday Flotilla fireworks display will be held adjacent to Motts Channel/Banks Channel, Wrightsville Beach, NC. Spectators will be observing from both the shore and from vessels. Due to the need of protection of mariners and spectators from the hazards associated with the fireworks display, vessel traffic will be temporarily restricted. Discussion of Comments and Changes No comments were received. Discussion of Rule The Coast Guard is establishing a safety zone on specified waters of Motts Channel. The regulated area will consist of a 1000 foot safety zone around Bird Island position latitude 34°12′41″ N, longitude 077°48′26″ W, which is located south of the Seapath Yacht Club, Wrightsville Beach, NC. The safety zone will be enforced from 6 p.m. to 8 p.m. on November 24, 2007. General navigation in the safety zone will be restricted during the event. Except for participants and vessels authorized by the Captain of the Port Representative, no person or vessel may enter or remain in the regulated area. Regulatory Evaluation 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. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. Although this regulation restricts access to the regulated area, the effect of this rule will not be significant because:

(i)The COTP may authorize access to the safety zone;

(ii)the safety zone will be in effect for a limited duration; and

(iii)the Coast Guard will make advance notifications via maritime advisories so mariners can adjust their plans accordingly. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit or anchor in that portion of Motts Channel/Banks Channel November 24, 2007 between the hours of 6 p.m. and 8 p.m. The safety zone will not have a significant impact on a substantial number of small entities, because the zone will only be in place for a limited amount of time and maritime advisories will be issued in advance, so the mariners can adjust their plans accordingly. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LTJG Adam Schmid, Response Division, Coast Guard Marine Safety Unit, Wilmington, North Carolina at

(910)772-2191. 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 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 U. S. Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism 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. Unfunded Mandates Reform Act 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. Taking of Private Property 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. Civil Justice Reform 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. Protection of Children 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 create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects 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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, we believe that this rule should be categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” is required for this rule. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 Subpart C as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T05-123, to read as follows: § 165.T05-123 Safety Zone: Motts Channel/ Banks Channel, Wrightsville Beach, North Carolina

(a)*Location:* The following area is a safety zone: All waters of Motts Channel/Banks Channel within 1000 feet of Bird Island at Wrightsville Beach, NC, approximate position latitude 34°12′41″ N, longitude 077°48′26″ W in the Captain of the Port Sector North Carolina zone as defined in 33 CFR 3.25-20.

(b)*Definition.* As used in this section the “on scene representative” means any U.S. Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port to act on his behalf.

(c)*Regulation:*

(1)In accordance with the general regulations in 165.23 of this part, entry into this zone is prohibited unless authorized by the Captain of the Port or the on scene representative.

(2)The operator of any vessel in the immediate vicinity of this safety zone shall:

(i)Stop the vessel immediately upon being directed to do so by any commissioned, warrant or petty officer on board a vessel displaying a U.S. Coast Guard Ensign;

(ii)Proceed as directed by any commissioned, warrant or petty officer on board a vessel displaying a U.S. Coast Guard Ensign.

(3)Persons or vessels requiring entry into or passage within the safety zone must request authorization from the Captain of the Port, Sector North Carolina or his on scene representative by telephone at

(252)247-4570 or

(252)247-4571 or by marine band radio on VHF channel 16 (156.8 MHz).

(d)*Enforcement period:* This regulation will be enforced from 6 p.m. to 8 p.m. on November 24, 2007. Dated: October 10, 2007. William D. Lee, Captain, U.S. Coast Guard, Sector North Carolina. [FR Doc. E7-21589 Filed 11-1-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2006-0590; FRL-8489-4] Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Requests for Rescission AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is finalizing the approval of revisions to the Nevada State Implementation Plan (SIP). These revisions were proposed in the **Federal Register** on August 28, 2006 and include certain regulations and statutes for which the State of Nevada is requesting rescission. The intended effect is to rescind unnecessary provisions from the applicable plan. DATES: *Effective Date:* This rule is effective on December 3, 2007. ADDRESSES: EPA has established docket number EPA-R09-OAR-2006-0590 for this action. The index to the docket is available electronically at *www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Andrew Steckel, EPA Region IX,

(415)947-4115, *steckel.andrew@epa.gov* . SUPPLEMENTARY INFORMATION: Throughout this document, “we,” “us” and “our” refer to EPA. Table of Contents I. Proposed Action II. Public Comments and EPA Responses III. EPA Action IV. Statutory and Executive Order Reviews I. Proposed Action On August 28, 2006 (71 FR 50875), under the Clean Air Act (CAA or “Act”), EPA proposed approval of certain revisions to the Nevada SIP and disapproval of certain other revisions. These revisions involve rules and statutory provisions previously approved in the Nevada SIP for which the State of Nevada is requesting rescission. In our August 28, 2006 proposed rule, we made final approval of those rescission requests that we proposed to approve contingent upon the receipt of certain public notice and hearing documentation from the State of Nevada. On January 3, 2007 (72 FR 11), based on public notice and hearing documentation provided by the State for most of the requested rescission, we finalized the rescissions for most of the subject rules and statutory provisions. On June 13, 2007 (72 FR 32529), we published a second final rule related to our August 28, 2006 proposed rule. In our June 2007 final rule, we rescinded a Federal Implementation Plan

(FIP)that we promulgated in the 1970's to regulate emissions of sulfur oxides from a now defunct smelter that had operated within White Pine County, Nevada. In our January 3, 2007 final rule, we listed 12 provisions for which the State had yet to provide documentation of public participation and for which, therefore, we were deferring final action. See 72 FR 11, at 16. On June 26, 2007, the Governor's designee, the Nevada Division of Environmental Protection (NDEP), submitted the necessary public participation documentation for 11 of the 12 provisions for which final action had been deferred in our January 3, 2007 final rule. 1 The 11 provisions are listed in the table below. Based on the documentation provided by NDEP on June 26, 2007, we now take final action to approve the requested rescission of the 11 provisions listed below. 1 NAC 445.617 (“Six-minute period”) is the lone rescission request among the 12 cited in the January 2007 final rule that is not being finalized today. In the submittal dated June 26, 2007, NDEP requests withdrawal of the rescission request for NAC 445.617 and, instead, replacement of NAC 445.617 in the SIP with approval of the current codification of the rule (i.e., NAC 445B.172). We will be taking action on submitted rule NAC 445B.172 in a separate document. Also, in the submittal dated June 26, 2007, NDEP provides public participation documentation for rescission of NAC 445.667 (“Excess emissions: Schedule maintenance; testing; malfunctions”), a rule covered by our proposal dated December 18, 2006 (71 FR 75690). We will take final action on rescission of NAC 445.667 in a separate document. SIP Provisions for Which the State's Rescission Request Is Approved SIP provision Title Submittal date Approval date NAC 445.477 Confidential information 10/26/82 03/27/84 NAC 445.554 Nuisance 10/26/82 03/27/84 NAC 445.596 Ringelmann chart 10/26/82 03/27/84 NAC 445.662 Confidential information 10/26/82 03/27/84 NAC 445.695 Schedules for compliance 10/26/82 03/27/84 NAC 445.698 Appeal of director's decision: Application forms 10/26/82 03/27/84 NAC 445.700 Violations: Manner of paying fines 10/26/82 03/27/84 NAC 445.844 Odors 10/26/82 03/27/84 NRS 445.401 Declaration of public policy 12/29/78 07/10/80 NRS 445.466 Commission regulations: Notice and hearing 12/29/78 07/10/80 NRS 445.497 Notice of regulatory action; Requirement; method; contents of notice 12/29/78 07/10/80 The majority of the provisions in the table above represent defined terms that are not used by any other provisions in the applicable SIP or represent provisions that are not required for SIPs and thus are unnecessary and appropriate for rescission. Our proposed action and related technical support document

(TSD)contain more information on the rules and statutory provisions cited above and our evaluation. II. Public Comments and EPA Responses EPA's August 28, 2006 proposed rule provided a 30-day public comment period. During this period, we received comments from Jennifer L. Carr and Michael Elges, NDEP, by letter dated September 25, 2006. In our January 3, 2007 final rule (72 FR 11), we summarized the comments from NDEP's letter and provided our responses. With respect to the 11 provisions for which final action is taken herein, NDEP indicated in its September 25, 2006 letter that it would be conducting the necessary public notice and hearing. NDEP's June 26, 2007 submittal provides the necessary public participation documentation and provides the basis for EPA to take this final action to approve the State's request to rescind the 11 provisions listed in the table above from the applicable Nevada SIP. III. EPA Action No comments were submitted that change our assessment of our proposed action. Therefore, as authorized in section 110(k) of the Act, EPA is finalizing the approval of the State's request to rescind the provisions listed in the table above from the applicable SIP. IV. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves rescissions of state law that are unnecessary to meet Federal requirements and imposes no additional requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule rescinds requirements under state law and does not impose any additional enforceable duty, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves rescissions of state law that are unnecessary to implement a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 2, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: October 16, 2007. Wayne Nastri, Regional Administrator, Region IX. Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart DD—Nevada 2. Section 52.1470 is amended by adding paragraph (c)(14)(xi) and (c)(25)(ii) to read as follows: § 52.1470 Identification of plan.

(c)* * *

(14)* * *

(xi)Previously approved on July 10, 1980 in paragraph (14)(ii) and now deleted without replacement: Nevada Revised Statutes

(NRS)sections: 445.401, 445.466, and 445.497.

(25)* * *

(ii)Previously approved on March 27, 1984, in paragraph (25)(i)(A) and now deleted without replacement: Nevada Administrative Code

(NAC)sections: 445.447, 445.554, 445.596, 445.662, 445.695, 445.698, 445.700, and 445.844. [FR Doc. E7-21447 Filed 11-1-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 65 [Docket No. FEMA-B-7745] Changes in Flood Elevation Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Interim rule. SUMMARY: This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations

(BFEs)is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents. DATES: These modified BFEs are currently in effect on the dates listed in the table below and revise the Flood Insurance Rate Maps (FIRMs) in effect prior to this determination for the listed communities. From the date of the second publication of these changes in a newspaper of local circulation, any person has ninety

(90)days in which to request through the community that the Mitigation Assistant Administrator of FEMA reconsider the changes. The modified BFEs may be changed during the 90-day period. ADDRESSES: The modified BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below. FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472,

(202)646-3151. SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided. Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data. The modifications are made pursuant to section 201 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 the other Federal, State, or regional entities. The changes BFEs are in accordance with 44 CFR 65.4. *National Environmental Policy Act.* This interim rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. *Regulatory Flexibility Act.* As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required. *Regulatory Classification.* This interim 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. *Executive Order 13132, Federalism.* This interim rule involves no policies that have federalism implications under Executive Order 13132, Federalism. *Executive Order 12988, Civil Justice Reform.* This interim rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 65 Flood insurance, Floodplains, Reporting and recordkeeping requirements. Accordingly, 44 CFR part 65 is amended to read as follows: PART 65—[AMENDED] 1. The authority citation for part 65 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 65.4 [Amended] 2. The tables published under the authority of § 65.4 are amended as follows: State and county Location and case No. Date and name of newspaper where notice was published Chief executive officer of community Effective date of modification Community No. North Carolina: Alamance City of Burlington (06-04-BY00P) May 15, 2007, May 22, 2007, *The Times-News* The Honorable Stephen M. Ross, Mayor of the City of Burlington, P.O. Box 1358, 425 South Lexington Avenue, Burlington, North Carolina 27215 August 20, 2007 370002 Dare Town of Nags Head (07-04-4138P) June 21, 2007, June 28, 2007, *The Coastland Times* Mr. Charles L. Cameron, Manager, Town of Nags Head, P.O. Box 99, 5401 South Croatan Highway, Nags Head, North Carolina 27959 June 13, 2007 375356 Dare Unincorporated Areas of Dare County (07-04-4138P) June 21, 2007, June 28, 2007, *The Coastland Times* Mr. Terry Wheeler, Manager, Dare County, P.O. Drawer 1000, 211 Budleigh Street, Manteo, North Carolina 27954 June 13, 2007 375348 Durham City of Durham (07-04-2980P) August 14, 2007, August 21, 2007, *The Herald-Sun* The Honorable William V. Bell, Mayor of the City of Durham, Office of the Mayor, 101 City Hall Plaza, Durham, North Carolina 27701 August 7, 2007 370086 Durham Unincorporated Areas of Durham County (07-04-2980P) August 14, 2007, August 21, 2007, *The Herald-Sun* Mr. Michael M. Ruffin, Manager, Durham County, 200 East Main Street, 2nd Floor, Old Courthouse, Durham, North Carolina 27701 August 7, 2007 370085 Orange Unincorporated Areas of Orange County (06-04-C141P) July 31, 2007, August 7, 2007, *Chapel Hill Herald* Mr. Moses Carey, Jr., Chairman of the Orange County, Board of Commissioners, 200 South Cameron Street, Hillsborough, North Carolina 27278 November 5, 2007 370342 Union Town of Indian Trail (06-04-BX22P) May 15, 2007, May 22, 2007, *The Enquirer Journal* The Honorable Sandy Moore, Mayor of the Town of Indian Trail, P.O. Box 2430, Indian Trail, North Carolina 28079 August 21, 2007 370235 Union Unincorporated Areas of Union County (06-04-BX22P) May 15, 2007, May 22, 2007, *The Enquirer Journal* Mr. Mike Shalati, Manager, Union County, 500 North Main Street, Room 925, Monroe, North Carolina 28112 August 21, 2007 370234 Wake Town of Wake Forest (07-04-0615P) August 2, 2007, August 9, 2007, *The Wake Weekly* The Honorable Vivian A. Jones, Mayor of the Town of Wake Forest, 401 Elm Avenue, Wake Forest, North Carolina 27587 November 7, 2007 370244 (Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”) Dated: October 29, 2007. David I. Maurstad, Federal Insurance Administrator of the National Flood Insurance Program, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E7-21597 Filed 11-1-07; 8:45 am] BILLING CODE 9110-12-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 11 [EB Docket No. 04-296; FCC 07-109] Review of the Emergency Alert System AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In this document, the Federal Communications Commission (Commission) amends its rules in order to ensure the efficient, rapid, and secure transmission of Emergency Alert System

(EAS)alerts in a variety of formats (including text, audio, and video) and via different means (broadcast, cable, satellite, and other networks), increasing the reliability, security, and efficacy of the nation's EAS network. DATES: The effective date is December 3, 2007. FOR FURTHER INFORMATION CONTACT: Thomas Beers, Policy Division, Public Safety and Homeland Security Bureau,

(202)418-1170, or TTY

(202)418-7233. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's *Second Report and Order* (Order) in EB Docket No. 04-296, FCC 07-109, adopted May 31, 2007, and released July 12, 2007. The complete text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554. This document may also be obtained from the Commission's duplicating contractor, Best Copy and Printing, Inc., in person at 445 12th Street, SW., Room CY-B402, Washington, DC 20554, via telephone at

(202)488-5300, via facsimile at

(202)488-5563, or via e-mail at *FCC@BCPIWEB.COM.* Alternative formats (computer diskette, large print, audio cassette, and Braille) are available to persons with disabilities by sending an e-mail to *FCC504@fcc.gov* or calling the Consumer and Governmental Affairs Bureau at

(202)418-0530, TTY

(202)418-0432. This document is also available on the Commission's Web site at *http://www.fcc.gov.* Synopsis of the Order Next Generation EAS 1. In the *Order,* we reaffirm the obligations of today's EAS Participants to maintain existing EAS and establish the framework for the nation's Next Generation EAS. This Next Generation EAS will include new and innovative technologies and distribution systems that will provide increased redundancy and resiliency for the delivery of emergency alerts. We also take steps to ensure that the upgraded EAS will meet the needs of all Americans, including persons with hearing and vision disabilities and those who do not speak English. Finally, we will continue to harness the benefits of existing EAS while the Next Generation EAS is developed and deployed. The combination of the existing and Next Generation EAS systems will ensure the continuity of EAS while the Next Generation EAS is being implemented, and ensure that EAS alerts reach the largest number of affected people by multiple communications paths as quickly as possible. 2. Below, we describe the four cornerstones of the Next Generation EAS:

(1)Maintaining the existing EAS network;

(2)utilizing a common messaging protocol, CAP, to be implemented by all EAS Participants following its adoption by FEMA;

(3)incorporating new authentication and security requirements; and

(4)fostering the deployment of new, redundant EAS delivery systems, including satellite, Internet, and wireline networks. Maintaining Existing EAS 3. Although a Presidential alert has never been sent over the EAS, the current EAS network has been used for state, local, and weather-related emergencies. We recognize that in certain emergency situations, battery-powered AM or FM receivers may be the primary source of emergency information for the general public. Broadcast and cable personnel are familiar with current EAS equipment and are trained in its use. In addition, it would be inadvisable to require immediate use of a new system until that system is fully in place and its reliability tested. We therefore do not agree with those commenters who argue that the existing EAS should be wholly abandoned or replaced at this time. 4. Instead, we conclude that broadcast, cable and other current EAS Participants should maintain the existing EAS, particularly since alternative delivery mechanisms, although potentially more robust, have yet to be deployed. We recognize, however, that EAS currently uses a station-relay message dissemination process that lacks the flexibility and redundancy of certain evolving digital communications systems. Consequently, we also require these current EAS Participants to upgrade their networks to the Next Generation EAS, as discussed below, while maintaining existing EAS. 5. *NOAA Weather Radio.* In addition, we disagree with those commenters who suggest that NWR should replace the existing EAS. We believe, however, that the NWR system should continue to be closely integrated with EAS. NWR is one of the principal sources of alert information, and is likely to continue to be the primary originator of weather-based alerts. We also recognize that voluntary efforts, including CEA's Public Alert TM Certification and Logo Program launched in April 2004, further enhance the value and potential of this proven emergency-alert delivery system. The record demonstrates that redundant alert-delivery systems will enhance the overall reach, efficacy, and reliability of the EAS as a whole. NWR provides an alternative source of emergency alerts, and we expect that it will continue to be an important component of EAS and the overall national public alert and warning system. We nevertheless caution EAS Participants that retransmit NWR alerts to ensure that such retransmission is consistent with our EAS rules and associated protocols. Common Alerting Protocol

(CAP)for EAS 6. In the *Further NPRM,* the Commission sought comment on the widespread assertion in the record that a common messaging protocol should be adopted to permit a digitally-based alert or warning to be distributed simultaneously over multiple platforms. The Commission noted that the Partnership for Public Warning had endorsed the OASIS Common Alerting Protocol

(CAP)for this purpose and that many public and private organizations responsible for alerts believed that CAP offered the most practical means of quickly creating an effective interface between emergency managers and multiple emergency alert distribution platforms. Accordingly, the Commission asked whether CAP should be adopted as the common messaging protocol for any future digital alert system, and particularly for EAS alerts. The Commission also asked whether CAP would allow simultaneous distribution to radio, television, and wireless media such as mobile telephones and personal digital assistants (PDAs), and how it would ensure uniformity of alerts across multiple platforms. Currently, the EAS and the NWS utilize the SAME protocol, which introduces special digital codes at the beginning and end of messages. SAME provides information concerning the originator of the alert, the event type, the areas affected, the duration of the alert, the time the alert was issued, and the station's call sign. SAME originally was developed to be transmitted over a radio medium with relatively simple devices receiving the message. For the most part, it performs well for the existing EAS and NWR but does not fully utilize the capabilities inherent in digital transmission. 7. The need for a more robust and flexible protocol that can take full advantage of digital technology has long been recognized. In 2000, the U.S. National Science and Technology Council issued its report, *Effective Disaster Warnings,* concluding that a “standard method should be developed to collect and relay instantaneously and automatically all types of hazard warnings and reports locally, regionally, and nationally for input into a wide variety of dissemination systems.” In 2001, more than 130 emergency managers and technologists initiated development of a common alert message standard. In 2003, this work became a part of the OASIS standards process of the Emergency Management Technical Committee. A year later, the Emergency Management Technical Committee released CAP version 1.0, which was revised in 2005 as CAP v. 1.1. 8. CAP is an open, interoperable standard that incorporates a language developed and widely used for web documents. Its standardized alert message format—based on the World Wide Web Consortium's (“W3C's”) Extensible Markup Language (“XML”)—is a text-based format that facilitates data sharing across different distribution systems. As noted by various commenters, the agreed-upon XML format of CAP can be accepted by a wide variety of devices or systems. The format also permits links to voice, audio or data files, images, and multilingual translations of the alert, and to links providing further information. 9. The CAP standard specifies what fields an alert message can contain and what information can be included in the particular fields. A CAP alert provides fields such as message type, scope, incident, event information, event certainty, sender, geographic scope, and the time when an alert becomes effective and expires. Because CAP has standardized alert elements, commenters assert it will facilitate accurate and meaningful message creation and decrease the potential for operator error. CAP also facilitates interoperability between devices, an attribute essential to establishing an EAS that can operate over multiple platforms. 10. Commenters who addressed the issue generally support the use of CAP as a means for standardizing emergency messages; and no parties indicated that CAP-based messages could not be readily accepted and processed by all EAS Participants. The USGS notes its own experience using CAP, and argues that CAP is an effective content standard that can be applied at interfaces between senders, transmitters, and receivers of alerts covering many of the common natural and man-made hazard situations. USGS concludes that CAP should be mandatory for the EAS. NASCIO also recognizes the flexibility of CAP, noting that any EAS initiator can take information from a CAP-based message and translate it into any other standard for distribution over a particular channel, network, or technology. CAP also is supported by individuals with hearing and sight disabilities, because it enables equivalent, multiple text and audio messages to be sent concerning the same event to a variety of devices that are accessible to such individuals. 11. We note that CAP also supports capabilities for a digital signature to authenticate the sender and validate the integrity of the text, and an encryption field that enables the encryption of the CAP message. An EAS initiator may encrypt, address, and otherwise secure a CAP alert, thus in part addressing security concerns that arise due to CAP's open text format. Further, CAP uniquely identifies each specific alert. Finally, CAP has been implemented by several government agencies including the USGS, NOAA NWS, and the Oregon Amber Alert Program. CAP also has been implemented in the Disaster Management Interoperability Services. Several governmental agencies, including FEMA and NOAA HAZCOLLECT, are testing CAP, and other agencies, such as the Center for Disease Control and the Virginia Department of Transportation, have endorsed it. We note that the U.S. Department of Defense and the U.S. Department of the Interior both voted for the adoption of CAP-V1.1. 12. We conclude that all EAS Participants will be required to accept alerts and warnings in the CAP format should that protocol be adopted by FEMA. This requirement applies to an EAS Participant regardless of whether the participant is utilizing existing EAS or the Next Generation EAS established in the *Order.* Although this requirement requires action by FEMA, we find that adopting it now furthers the prompt development of a state-of-the-art, next-generation national EAS. Significantly, many EAS Participants currently are implementing other revisions to their EAS systems, and they can incorporate CAP into these revisions. Specifically, should FEMA adopt CAP as the common alerting protocol for EAS alerts, EAS Participants must accept CAP-based alerts 180 days after the date that FEMA publishes the applicable technical standards for such CAP alerts. Because most commenters urge the Commission to adopt the CAP format, we find that EAS Participants are already aware that CAP will likely be adopted, and we believe that 180 days will give them adequate time to prepare to receive CAP alerts. EAS Participants have been on notice since November 10, 2005, when the *FNPRM* was issued, that the EAS delivery standards might change. Thus, we find that 180 days will give EAS participants a reasonable period of time in which to implement changes that they should have been expecting for over 18 months since the FNPRM was issued. We further find that 180 days is reasonable in light of the significant public interest, to protect life and property, in implementing next generation EAS systems as soon as possible. We also note that EAS Participants will have the time period between the release of the *Order* and FEMA action for preparation. Authentication and Security 13. In the *2004 NPRM,* the Commission noted that security and encryption were not the primary design criteria when EAS was developed and initially implemented, and that emergency managers were becoming more aware of potential vulnerabilities within the system. The Commission expressed concern that the EAS may be subject to unauthorized access, and that a legitimate EAS signal could be subject to hacking or jamming. Although ENDECs currently have the capability for password protection, it is up to each EAS Participant to implement the safeguard, and there is no means to monitor the extent to which EAS Participants employ passwords. Additionally, when facilities are operating unattended, no one is available on-site to intervene should unauthorized use occur. Accordingly, the Commission sought comment on how to improve the security of EAS distribution methods, information, and equipment and how to ensure the security of any public warning system. It also sought comment on the authentication and verification of EAS alerts. Cox agrees with the FCC that there are legitimate concerns regarding the security of the EAS, and contends that any attacks on EAS or unauthorized use could be devastating. As such, Cox urges the adoption of methods to keep the system secure from intentionally false control or sabotage. Radio stations WTOP(AM), WTOP-FM, and WXTR(AM)

(WTOP)contend the security of EAS distribution channels is crucial to the system working properly. WTOP suggests that the security of emergency and test messages can be improved by switching to a system which encrypts messages and guarantees secure delivery with password protection and confirmation of delivery. NAB urges the FCC to coordinate with FEMA and equipment manufacturers to look for technical solutions for ensuring the security of EAS. Contra Costa states that digital technology, particularly the use of the CAP protocol, can protect and verify the security of public warning communication links, and can enable the consistent and comprehensive monitoring of all kinds and levels of warning activity nationwide. Contra Costa states just as the Internet Protocols enable various kinds of computers to work together, CAP can provide the basis for a secure “warning internet” that can leverage all our warning assets to achieve more than any single system can alone. 14. We agree with commenters that all EAS Participants should authenticate the source of, and validate the contents of, EAS alerts. As discussed above, CAP has the capability to allow those who initiate and retransmit EAS alerts to encrypt, authenticate, and validate EAS alerts. We believe that EAS Participants that configure their networks to receive CAP-formatted messages will be able to satisfactorily authenticate and validate EAS alerts in consultation with FEMA. Accordingly, should FEMA adopt CAP as the common alerting protocol for EAS alerts, all EAS Participants must configure their systems to incorporate CAP security functions within 180 days after FEMA publishes the standards for authentication and validation of CAP-formatted alerts. We expect EAS Participants to cooperate with FEMA in its efforts to develop policies, plans, and procedures that meet FEMA's requirements for the new delivery systems and CAP protocol adopted by FEMA. Next Generation Distribution Systems 15. Recent experience demonstrates that natural disasters and terrorist incidents can adversely impact terrestrial telecommunications infrastructure. To achieve the Commission's goals of enhancing the redundancy, reliability and security of EAS, we enable the use of diverse EAS distribution platforms. Our actions today also will ensure that the Secretary of Homeland Security can implement the President's directive to provide “as many communications pathways as practicable” to reach the American people during crises. 16. The development of alternative distribution systems is already underway. For example, we note that the Association of Public Television Stations (“APTS”) has proposed a hybrid, satellite/DTV broadcast system that was an integral part of FEMA's Digital Emergency Alert System

(DEAS)National Capital Region Pilot. On July 12, 2006, FEMA and APTS announced the successful completion of Phase II of the DEAS pilot, and that the new DEAS would be operational in the Gulf Coast and Atlantic regions by the end of 2006, and will be deployed nationally by the end of 2007. 17. We agree with commenters that satellite-based alert distribution could be a valuable complement to the existing EAS station-relay distribution method. The vast coverage area of satellite signal footprints would allow immediate alerting of substantial portions of the country with appropriate equipment. Satellite systems also are generally immune from natural disasters and therefore may provide critical redundancy in the event that terrestrial wireline or wireless infrastructure is compromised. We also agree with commenters that Internet-based systems may enhance the resiliency of the EAS distribution network. The Internet is a robust, packet-switched network with intelligent routing, and is designed to provide alternative routes to reach almost all users. Moreover, the Internet is ubiquitous and can enhance the geographic reach of EAS. The open design of the Internet also means that EAS applications can be designed to meet the specific needs of EAS without limitation by the network. 18. We conclude that the distribution architecture of the existing EAS should be enhanced. The record underscores that EAS could be improved by authorizing the delivery of alerts through the existing EAS coupled with new redundant, distribution systems for EAS. We conclude, however, that FEMA is best positioned to determine the types of additional EAS systems that should be accommodated by EAS Participants. We expect that EAS Participants will collaborate closely with FEMA and other governmental entities to fully implement such requirements. Accordingly, should FEMA announce technical standards for any Next Generation EAS alert delivery system, EAS Participants must configure their networks to receive CAP-formatted alerts delivered pursuant to such delivery system, whether wireline, Internet, satellite or other, within 180 days after the date that FEMA announces the technical standards for such Next Generation EAS alert delivery. CAP and Next Generation EAS: Better Serving the Needs of Persons With Disabilities and Non-English Speakers 19. *Serving the needs of persons with disabilities.* President Bush's Executive Order mandates that the Secretary of Homeland Security “include in the public alert and warning system the capability to alert and warn all Americans, including those with disabilities and those without an understanding of the English language.” We believe that CAP could provide an important tool for helping to accomplish this goal. 20. CAP should facilitate the provision of functionally equivalent EAS alerts and warnings to persons with disabilities. Using CAP, the original format of warning messages could be converted into various formats, including text, video, and audio. Critical information graphically portrayed, scrolled, or crawled on the screen also could be accompanied by an audio description. Persons with hearing disabilities would be able to read the entire emergency message instead of a brief summary. Audio and visual formats are both important and could contain the same information. Moreover, a CAP-formatted message could be converted to synthesized speech, as is done by NWS weather alerts, for visually impaired persons. Accordingly, in the *Order* , we promote the delivery of audio, video, and text messages to persons with disabilities by requiring EAS Participants to accept CAP-formatted alerts and warnings, should CAP be adopted by FEMA. 21. While CAP is promising, however, it may not be the whole answer for making EAS alerts accessible to persons with disabilities, and it does not address the broader question of making emergency and public safety information available to persons with disabilities. For example, Section 79.2 of the Commission's rules requires video programming distributors to make the audio portion of emergency information accessible to persons with hearing disabilities using closed captioning or other methods of visual presentation. Video programming distributors also must ensure that emergency information provided in the video portion of a regularly scheduled newscast, or a newscast that interrupts regular programming, is accessible to persons with visual disabilities through aural description in the main audio, such as open video description. Emergency information is defined as information about a current emergency that is intended to further the protection of life, health, safety, and property, i.e. critical details regarding the emergency and how to respond to the emergency. 22. We are issuing a *Further Notice of Proposed Rulemaking* to re-examine the best way to make EAS and other emergency information accessible to persons with disabilities. We will invite comment on:

(1)Presentation of the audio feed in text format, and vice-versa;

(2)making emergency information available to various devices commonly used by persons with disabilities; and

(3)providing emergency messages in multiple formats to meet the needs of persons with disabilities. 23. *Serving non-English Speakers.* We also affirm our commitment that non-English speakers should have access to EAS alerts as soon as the simultaneous transmission of multilingual messages is practicable. We believe that the first step toward more effectively serving non-English speakers, consistent with the Secretary of Homeland Security's responsibility to enable alerting of “those without an understanding of the English language” is to require the use of CAP, conditional on its adoption by FEMA. Requiring EAS Participants to be able to receive CAP-formatted alerts will facilitate more accurate and detailed multilingual alerts. At the same time, we also expect that EAS participants will simultaneously transmit multilingual CAP-formatted messages by EAS Participants as soon as such transmission is practicable. For example, this could happen either as a result of the development of comprehensive, nation-wide Next Generation EAS under FEMA's auspices, or pursuant to the earlier development of CAP-based transmission systems at the state level per coordination between state planners and FEMA. This requirement will ensure that the initiator of any EAS alert has the technological capability to deliver simultaneously messages in English and any other language determined to be appropriate for a given alert. 24. The rules we adopt provide the groundwork for transmission of multilingual EAS alerts and warnings. CAP, however, may not be a complete answer for making EAS alerts available to non-English speakers, and is not a comprehensive solution for making general emergency and public safety information available to non-English speakers. Indeed, we believe that Petitioners' request is broader than the formal EAS structure and raises important questions about the availability of emergency information to the non-English speaking audience. We initiate today a Further Notice to seek additional comment on these proposals. Although we hope that the stakeholders will work together, under our auspices, to reach a resolution prior to the conclusion of our proceeding on these issues, we are prepared to issue an order addressing these issues within six months. 25. In order to begin focusing on these issues quickly, we direct the Public Safety and Homeland Security Bureau to convene a discussion (or a series of discussions) at the Commission among stakeholders as soon as possible, and to place a report describing the results in the public docket within 30 days of release of the *Order* . Expanding the Base of EAS Participants 26. *Wireline Video Participation in EAS* . We agree with commenters that Wireline Video Providers should be considered Participants under our EAS rules. The EAS plays a critical role in providing vital public safety information. The long-term resilience of the EAS could be significantly increased by careful implementation that could better accommodate, and even harness, the innate flexibility of IP-based networks that can route around damaged nodes. Moreover, a viewer's reasonable expectation regarding the availability of alerts over television programming is identical, whether the programming is over-the-air broadcasting, cable, DBS, or a new wireline video service. By adopting a technologically neutral EAS obligation today, the Commission is enabling these emerging service providers to integrate EAS at an early developmental stage. 27. Under section 624(g) of the Act and the Commission's EAS regulations, providers of “cable systems” must participate in EAS. Section 624(g) of the Act provides that “each cable operator shall comply with such standards as the Commission shall prescribe to ensure that viewers of video programming on cable systems are afforded the same emergency information as is afforded by the emergency broadcasting system pursuant to Commission regulations in subpart G of part 73, title 47, Code of Federal Regulations.” The Commission imposed EAS regulations on cable operators pursuant to this mandate in 1994, concluding that cable “is invaluable in the dissemination of information during emergencies.” The term “cable operator” means a person “who provides cable service over a cable system,” including “a facility of a common carrier which is subject, in whole or in part, to the provisions of title II of this Act * * * to the extent such facility is used in the transmission of video programming directly to subscribers, unless the extent of such use is solely to provide interactive on-demand services.” Thus, section 624(g) expressly authorizes the imposition of EAS requirements on Wireline Video Providers to the extent that they qualify as “cable operators” under the Act. 28. To the extent that Wireline Video Providers do not qualify as “cable operators” under the Act, we require that they participate in EAS pursuant to our Title I ancillary jurisdiction and in connection with our specific responsibilities under sections 624(g) and 706. As a general matter, the Commission has discretion to use ancillary jurisdiction when the Commission has Title I subject matter jurisdiction over the service and the assertion of jurisdiction is “reasonably ancillary to the effective performance of [its] various responsibilities.” Wireline Video Providers fall within the scope of the Commission's jurisdiction because they provide “interstate * * * communication by wire.” At least some of their services involve transmission across state lines, meeting the definition of “interstate communication,” and they are “wire communication,” which is “transmission of * * * pictures * * * and sounds * * * by aid of wire, cable, or other like connection.” Thus, the Commission has subject matter jurisdiction over these services. We also find that imposing an EAS requirement is reasonably ancillary to the effective performance of our responsibilities. Wireline Video Providers' participation in the EAS will advance the animating purpose of section 624(g) by ensuring that their video subscribers have access to the same emergency information as broadcast and cable television viewers. Indeed, we believe that their EAS participation is necessary to preserve and advance the goals of section 624(g), as Wireline Video Providers offer competitive alternatives to the video programming available through broadcast and cable television, and are likely to reach increasingly large portions of the American public as they deploy their services. Moreover, requiring Wireline Video Providers to participate in EAS also will further our core public safety mission under Title I, which requires us to take steps to “promot[e] safety of life and property,” and section 706, and is consistent with prior Commission actions. Accordingly, we conclude that we have ancillary jurisdiction to require even those Wireline Video Providers that may not be cable operators under the Act to participate in EAS. 29. As a policy matter, we believe that the reasonable expectations of viewers should guide our efforts to encourage the development of a more comprehensive EAS system. We reaffirm that our long-term goal is to incorporate as many communications technologies as possible into a comprehensive, flexible, and redundant system to deliver EAS alerts quickly to the largest number of consumers. 30. Wireline Video Providers should be subject to the same EAS requirements as providers of Digital Cable Systems. We therefore amend our EAS rules to specifically include Wireline Video Providers. Wireline Video Providers are EAS Participants, however, only to the extent they provide video services; our EAS rules do not impose mandatory EAS obligations on wireline telephone companies providing traditional landline telephone services at this time. Wireless Participation in EAS 31. Because the WARN Act directs the Commission to initiate a rulemaking regarding the establishment of an alerting system for commercial mobile service

(CMS)providers that voluntarily elect to transmit emergency alerts, and the schedule set by the WARN Act precludes initiation of such rulemaking until a later date, we do not address commercial wireless carrier participation in EAS in the *Order* . State Level and Geographically Targeted EAS Alerts 32. *Receipt of State-Level Messages* We believe that voluntary participation by cable and broadcast EAS Participants in accommodating state and local level alerting in the existing EAS has been generally successful. Nevertheless, we conclude there are compelling policy reasons to order EAS Participants to receive CAP-formatted EAS alerts activated by state governors or their designees. First, we again note that EAS use to date has been overwhelmingly related to weather and state and local alerts. We also believe that states will be more inclined to deploy the necessary resources to upgrade to Next Generation EAS, including the ability to simultaneously transmit multiple and differentiated CAP-formatted messages, if the states have a particular—and FCC-enforceable—stake in the EAS during state and local emergencies. We conclude, therefore, that all EAS Participants within a state are required to be prepared to receive state-level messages delivered to the participant by the state's governor (or the governor's designee) within 180 days from the date FEMA adopts CAP, so long as such delivery is explicitly described in a state EAS plan that is submitted to and approved by the Commission. In addition, we believe that other public officials may, in appropriate circumstances, activate EAS alerts. We seek comment in the attached Further NPRM about which officials should be permitted to activate EAS alerts and under what circumstances. 33. We recognize that requiring EAS Participants to receive emergency alerts directly from state political subdivisions, such as counties and cities, could be unduly complex and costly and would create the potential for some alerts to reach those who may not be affected by a particular emergency. Accordingly, we will only require EAS Participants to receive CAP-formatted EAS messages delivered to them by a state governor (or the governor's designee), or by FEMA (or its designee) on behalf of a state. We find that requiring EAS Participants to receive CAP-formatted EAS messages delivered by a state governor of any state in which they provide service falls within the scope of our Title I subject matter jurisdiction as well as our public interest authority to grant licenses for radio communication under Title III of the Act. “[P]romoting safety of life and property through the use of wire and radio communication” is a core mission of the FCC under Title I, Title III authorizes the FCC to grant radio licenses in the public interest, and the Commission is authorized to “make such rules and regulations * * * as may be necessary in the execution of its functions,” and to “[m]ake such rules and regulations * * * not inconsistent with law, as may be necessary to carry out the provisions of this Act * * *.” Developing and maintaining an effective, reliable, integrated, flexible, and comprehensive EAS system is a fundamental and longstanding FCC mission under the Communications Act. 34. Requiring EAS Participants to receive state-level alerts delivered pursuant to, and upon adoption by FEMA of CAP advances the Commission's policy objectives and serves the public interest by ensuring the ability of state governors to disseminate emergency information via EAS facilities. State governments play an essential role in providing emergency information to the public. The Commission's EAS regulations always have accounted for the importance of state-level alerts, but we now conclude that mandating receipt of state-level EAS messages will further our core public safety mission. 35. Exercising ancillary jurisdiction to require EAS participants to receive messages delivered to them by a state governor also furthers other statutory goals. Section 615 requires the Commission to “encourage and support efforts by States to deploy comprehensive end-to-end emergency communications infrastructure and programs,” while section 706 grants specific, communications-related powers to the President in time of war or national emergency. In such event, the President may, for example, take control of, or suspend or amend the rules and regulations applicable to, any or all cable and radio and television broadcast stations within the Commission's jurisdiction. Commission authority to regulate participation by cable systems in the emergency alerting process stems primarily from section 624(g) of the Act. That provision requires the Commission to ensure that cable viewers are afforded the same access to emergency communications as broadcast viewers and listeners. Additionally, the Americans with Disabilities Act strives to make all facets of our society fully accessible to individuals with disabilities. Finally, in light of the President's 2006 *Executive Order,* which directs the Commission to adopt rules to ensure that communications systems have the capacity to transmit alerts and warnings to the public as part of the public alert and warning system, we note that our action today is consistent with that Presidential directive as well as with emergency preparedness goals expressed by Congress in other statutes. 36. Accordingly, we reject as without merit NAB's argument that the Commission lacks authority to mandate participation in state-level EAS alerts. NAB points out that section 706 concerns Presidential communications, and the executive orders delegating authority to the FCC pursuant to section 706 largely concern the development of a national-level communications capability to serve Presidential needs, rather than state or local needs. Section 706 is not the only source of FCC authority to impose EAS requirements, however. The Commission's core public safety mission under Title I is not limited to national emergencies, nor is our Title III authority to grant radio licenses in the public interest so limited. Indeed, the *Executive Order* broadly affirms that “[i]t is the policy of the United States to have an effective, reliable, integrated, flexible, and *comprehensive system* to alert and warn the American people * * *, *taking appropriate account of* * * * *all levels of government in our Federal system* * * *.” We could not ensure a “comprehensive” system without taking state governments into account. The FCC's past reliance on voluntary state-level EAS participation reflects a policy judgment, rather than a lack of authority, as NAB suggests. 37. NAB also argues that the Commission cannot rely on section 1 because requiring state-level EAS participation implicates programming content. The only support that NAB offers for this argument is the D.C. Circuit's statement in *Motion Picture Ass'n of America, Inc.* v. *FCC* that “[o]ne of the reasons why section 1 has not been construed to allow the FCC to regulate programming content is because such regulations invariably raise First Amendment issues.” NAB's reliance on this statement is misplaced. In the *MPAA* decision, the Commission was relying on Title I alone to regulate programming content in the face of a statutory provision regarding video descriptions that the court interpreted as limiting FCC authority. Here, in contrast, we rely on Title III as well as Title I to mandate the carriage of emergency information. Requiring the carriage of emergency information also is a longstanding function of the Commission. NAB fails to explain how requiring state-level EAS participation implicates programming content in a manner different from the longstanding requirement of national-level EAS participation, which NAB does not challenge. 38. In addition to the source of our legal authority to require participation in state-level EAS, we also must consider the facilities and architecture of the various EAS Participants in determining how best to implement a state-level EAS requirement. We note that the existing EAS network architecture is based on a broadcast model of localized receipt and distribution by radio, television, and cable service providers using ENDEC units situated throughout their service areas. We recognize that certain other EAS Participants may have organized their service infrastructure on a national, not regional, basis. For example, the Commission recognized in the *First Report and Order* that SDARS “is by nature a national service and that as a result the development of methods to ensure receipt of state and local alerts by SDARS licensees is likely to be challenging.” Requiring these carriers to establish monitoring capability in every state where they do business could prove to be unduly burdensome. Satellite carriers, in particular, have expressed a need for a single receive point for EAS alerts that would complement their organizational structure. 39. We do not require SDARs and DBS providers to accommodate state-level alerts given the national nature of their broadcast area. We note that SDARS and DBS cannot accommodate state-level alerts at present and might not be able to do so even after the full implementation of Next Generation EAS. In the United States, there are two licensed SDARS operators: Sirius Satellite Radio, Inc. (“Sirius”) and XM Radio, Inc. (“XM”). Both licensees transmit their programming via satellite directly to subscribers' receivers on a nationwide basis. In the *First Report and Order* , the Commission required the SDARS licensees to transmit national level EAS messages on all channels on their systems. In the *Further NPRM* , the Commission sought comment on how technologies like SDARS, which are designed to receive and deliver national programming, could deliver state and local alerts. Although some potential, developing functionalities may enable SDARS to support geo-targeting, such as state-level alerts, in the future, XM expressed concerns that its current system cannot support geographical targeting of even state-level alerts to affected subscribers. XM states that there are two impediments for SDARS to transmit state or local alerts—a satellite radio provider does not have an ENDEC unit located in every area where a local alert might originate, and a satellite radio provider's programming reaches subscribers nationwide. Because SDARS providers face technical difficulties in distributing even state-level alerts to their subscribers, we will not at this time require SDARS to provide geographically-targeted alerts, including state-level alerts. 40. Likewise, DBS satellite service providers, such as EchoStar (Dish Network) and DIRECTV, transmit video programming on a nationwide basis to subscribers over a wide area. DIRECTV and PanAmSat state that currently DBS systems cannot distribute state and local alerts without interrupting programming across a wide area. DIRECTV also states that its system currently does not have the capability to receive, sort, and disseminate state and local EAS messages only to the subscribers in the affected areas. Because DBS providers also face technical difficulties in distributing alerts to portions of their subscribers, we will not at this time require DBS to provide geographically-targeted alerts, including state-level alerts. Geographically Targeted Alerts at Less Than State-Level 41. Although we are limiting the requirement that EAS Participants receive state level messages to messages received from state governors (or their designees) pursuant to CAP, we do not seek to restrict state use of the EAS network to only emergency messages that require statewide distribution. A governor could, for example, determine that certain emergencies warrant use of the EAS network to deliver a geographically-targeted alert to particular regions. Employing CAP will facilitate such geo-targeting, at least in connection with some technologies. Accordingly, we also require EAS Participants to deliver emergency alerts to areas smaller than a state. In order to transmit such targeted alerts, however, EAS Participants must be provided with CAP-formatted messages containing appropriate codes. Further, EAS Participants may comply with this requirement by utilizing geographic-specific alerts such as subscripts utilizing localized information. Expanding our state-level alert transmission requirement to include geographically targeted alerts will afford each state governor the ability to determine the types and geographic scope of emergency alerts provided to residents via the EAS network, in coordination with the ability of EAS Participants in his or her state to accommodate such alerts. Importantly, however, in adopting this requirement, we note that terrestrial broadcasters may not presently have the technical ability to restrict delivery of a targeted alert solely to the affected portion of their service area. This type of restriction is not necessary in order to comply with the requirements established in this Order. Coordination With State and Local Governments 42. For nearly half a century, the Commission has encouraged state and local participation in the EAS (and its predecessor, the EBS), and we take additional steps in the Order that will ensure the effective and efficient participation by states and local jurisdictions in the EAS. We note that the SECCs, industry participants, and state and local officials have worked closely with Commission staff to ensure the efficacy of the EAS, resulting in EAS plans for all 50 states. The Commission has reviewed and approved EAS plans for a number of states, and continues to have a cooperative, highly effective relationship with the SECCs. 43. As a result of the actions we take today to ensure that state governors have a robust and reliable EAS network at their disposal, states will likely need to revise their EAS plans to specify how and what types of EAS alerts they will transmit to EAS Participants. Such information will enable the Commission, FEMA, affected EAS Participants, and other interested parties to ensure that these plans are implemented successfully. While we do not dictate specific plan revisions other than those set forth herein for implementing mandatory state-level alerts, we encourage states to include information regarding redundant distribution of EAS alerts. Since state EAS plans will be required to contain information concerning our new requirement that EAS Participants must distribute EAS alerts delivered by state governors, plans should specify how the governor's CAP-formatted EAS messages will be transmitted to all EAS Participants who provide services in the state. We also encourage states to submit an electronic data file specifying monitoring assignments and the paths for the Emergency Action Notification

(EAN)from the NP to each station in their plans. We believe that such an electronic submission would facilitate the Commission's revision of the EAS “Map Book” required under the EAS rules. We also urge states to provide detailed information identifying the monitored and monitoring broadcast stations. 44. In order to ensure that the Commission has sufficient notice of revised EAS plans, we will require state and local entities to file modified plans with the Commission at least 90 days before the effective date of any revision to their EAS plans or their EAS designations. In addition, we will require state and local entities to annually confirm their plans and designations. 45. We also agree with commenters and the specific recommendation of the Independent Panel that the Commission should proactively provide EAS training to interested parties. We agree with Contra Costa that education to public safety and citizens is critical in making any type of infrastructure successful. We also believe that the Alaska Broadcasters Association and the State Emergency Communications Committee (Joint Parties) in our EAS proceeding are correct in recommending that training be provided for emergency managers as well as subject broadcasters, cable systems and other media operators. We take particular note of the argument of the Ohio Association of Broadcasters that proper training (and retraining) is a critical component of EAS, and supports training programs at the local level. OAB believes the Federal government also should be responsible for providing guidance to ensure that an appropriate minimum level of training of emergency management personnel is provided. According to OAB, a national training standard would ensure that training of persons who administer and activate EAS is uniform throughout local communities, states, and among federal, state and local government agencies. Accordingly, we hereby instruct the Commission's Public Safety and Homeland Security Bureau to coordinate with FEMA on the appropriate requirements for and resources to conduct EAS training programs to ensure states and other interested parties can implement the Next Generation EAS. Assessing EAS Operation 46. In the *Further Notice* , we asked whether performance standards are necessary to ensure that Next Generation technologies deliver alerts to the American public in a timely and accurate fashion. We noted that proposed standards could include the length of time it takes to receive a message and the accuracy of the message. 47. It is vital that the EAS operates as designed in an emergency. We intend to examine several potential mechanisms to ensure that is the case. In the *Further Notice of Proposed Rulemaking* , we seek comment on several options, including:

(1)Additional testing;

(2)station certification of compliance; and

(3)assessments of EAS performance after an alert has been triggered. We will revisit the issue of performance standards if it appears that they are warranted. I. Procedural Matters A. Paperwork Reduction Act Analysis 48. This *Second Report and Order* contains new and modified information collection requirements subject to the Paperwork Reduction Act of 1995 (“PRA”), Public Law 104-13. It will be submitted to the Office of Management and Budget (“OMB”) for review under section 3507(d) of the PRA. B. Congressional Review Act 49. The Commission will send a copy of this Second Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act (“CRA”), *see* 5 U.S.C. 801(a)(1)(A). II. Final Regulatory Flexibility Analysis 50. As required by the Regulatory Flexibility Act (“RFA”), an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the Further Notice of Proposed Rulemaking in EB Docket 04-296 ( *“First Report and Order and FNPRM”* ). The Commission sought written public comment on the proposals in the *EAS NPRM* , including comment on the IRFA. This Final Regulatory Flexibility Analysis (“FRFA”) conforms to the RFA. Need for, and Objectives of, the Rules 51. The *Second Report and Order* adopts rules that set the framework for a Next Generation EAS. In the Order, we take the following actions to establish service requirements for a Next Generation EAS, and establish schedules by which industry segments must transition to the new system:

(1)Require EAS Participants to configure their systems to accept EAS alerts formatted in the Common Alerting Protocol (“CAP”) format no later than 180 days after FEMA announces the technical standards and requirements for CAP-formatted messages;

(2)require EAS Participants to configure their systems to authenticate and validate EAS alerts formatted in the CAP format no later than 180 days after FEMA announces the standards for authentication and validation of CAP-formatted messages;

(3)require EAS Participants to receive and transmit state-level messages delivered to the Participant by the state's governor (or the governor's designee) within 180 days from the date FEMA adopts CAP, so long as such delivery is explicitly described in a state EAS plan that is submitted to and approved by the Commission;

(4)require wireline common carriers that provide video programming service to receive and distribute EAS messages; and

(5)delegate authority to the Chief, Public Safety and Homeland Security Bureau to perform actions that will facilitate proper implementation of our rules and resolution of issues as set forth herein. Summary of Significant Issues Raised by Public Comments in Response to the IRFA 52. There were no comments filed that specifically addressed the IRFA. Description and Estimate of the Number of Small Entities to Which Rules Will Apply 53. The RFA directs agencies to provide a description of, and, where feasible, an estimate of, the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which:

(1)Is independently owned and operated;

(2)is not dominant in its field of operation; and

(3)satisfies any additional criteria established by the Small Business Administration (“SBA”). 54. A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 2002, there were approximately 1.6 million small organizations. The term “small governmental jurisdiction” is defined as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” As of 1997, there were approximately 87,453 governmental jurisdictions in the United States. This number includes 39,044 county governments, municipalities, and townships, of which 37,546 (approximately 96.2 percent) have populations of fewer than 50,000, and of which 1,498 have populations of 50,000 or more. Thus, we estimate the number of small governmental jurisdictions overall to be 84,098 or fewer. Nationwide, there are a total of approximately 22.4 million small businesses, according to SBA data. 55. *Television Broadcasting.* The SBA has developed a small business sized standard for television broadcasting, which consists of all such firms having $13 million or less in annual receipts. Business concerns included in this industry are those “primarily engaged in broadcasting images together with sound.” According to Commission staff review of BIA Publications, Inc. Master Access Television Analyzer Database, as of May 16, 2003, about 814 of the 1,220 commercial television stations in the United States had revenues of $12 million or less. We note, however, that, in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. There are also 2,127 low power television stations (“LPTV”). Given the nature of this service, we will presume that all LPTV licensees qualify as small entities under the SBA size standard. 56. *Radio Stations.* The revised rules and policies potentially will apply to all AM and commercial FM radio broadcasting licensees and potential licensees. The SBA defines a radio broadcasting station that has $6.5 million or less in annual receipts as a small business. A radio broadcasting station is an establishment primarily engaged in broadcasting aural programs by radio to the public. Included in this industry are commercial, religious, educational, and other radio stations. Radio broadcasting stations which primarily are engaged in radio broadcasting and which produce radio program materials are similarly included. However, radio stations that are separate establishments and are primarily engaged in producing radio program material are classified under another NAICS number. According to Commission staff review of BIA Publications, Inc. Master Access Radio Analyzer Database on March 31, 2005, about 10,840 (95 percent) of 11,410 commercial radio stations have revenue of $6 million or less. We note, however, that many radio stations are affiliated with much larger corporations having much higher revenue. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action. 57. *Cable and Other Program Distribution.* The SBA has developed a small business size standard for cable and other program distribution, which consists of all such firms having $12.5 million or less in annual receipts. According to Census Bureau data for 1997, in this category there was a total of 1,311 firms that operated for the entire year. Of this total, 1,180 firms had annual receipts of under $10 million, and an additional 52 firms had receipts of $10 million to $24,999,999. Thus, under this size standard, the majority of firms can be considered small. In addition, limited preliminary census data for 2002 indicate that the total number of cable and other program distribution companies increased approximately 46 percent from 1997 to 2002. 58. *Cable System Operators (Rate Regulation Standard).* The Commission has developed its own small business size standard for cable system operators, for purposes of rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide. We have estimated that there were 1,065 cable operators who qualified as small cable system operators at the end of 2005. Since then, some of those companies may have grown to serve over 400,000 subscribers, and others may have been involved in transactions that caused them to be combined with other cable operators. Consequently, the Commission estimates that there are now fewer than 1,065 small entity cable system operators that may be affected by the rules and policies proposed herein. 59. *Cable System Operators (Telecom Act Standard).* The Communications Act of 1934, as amended, (“Act”) also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that there are 67,700,000 subscribers in the United States. Therefore, an operator serving fewer than 677,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. Based on available data, the Commission estimates that the number of cable operators serving 677,000 subscribers or fewer, totals 1,065. The Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, and therefore are unable, at this time, to estimate more accurately the number of cable system operators that would qualify as small cable operators under the size standard contained in the Act. 60. *Multipoint Distribution Systems.* The established rules apply to Multipoint Distribution Systems (“MDS”) operated as part of a wireless cable system. The Commission has defined “small entity” for purposes of the auction of MDS frequencies as an entity that, together with its affiliates, has average gross annual revenues that are not more than $40 million for the preceding three calendar years. This definition of small entity in the context of MDS auctions has been approved by the SBA. The Commission completed its MDS auction in March 1996 for authorizations in 493 basic trading areas. Of 67 winning bidders, 61 qualified as small entities. At this time, we estimate that of the 61 small business MDS auction winners, 48 remain small business licensees. 61. MDS also includes licensees of stations authorized prior to the auction. As noted above, the SBA has developed a definition of small entities for pay television services, cable and other subscription programming, which includes all such companies generating $13.5 million or less in annual receipts. This definition includes MDS and thus applies to MDS licensees that did not participate in the MDS auction. Information available to us indicates that there are approximately 392 incumbent MDS licensees that do not generate revenue in excess of $11 million annually. Therefore, we estimate that there are at least 440 (392 pre-auction plus 48 auction licensees) small MDS providers as defined by the SBA and the Commission's auction rules which may be affected by the rules adopted herein. In addition, limited preliminary census data for 2002 indicate that the total number of cable and other program distribution companies increased approximately 46 percent from 1997 to 2002. 62. *Instructional Television Fixed Service.* The established rules would also apply to Instructional Television Fixed Service (“ITFS”) facilities operated as part of a wireless cable system. The SBA definition of small entities for pay television services also appears to apply to ITFS. There are presently 2,032 ITFS licensees. All but 100 of these licenses are held by educational institutions. Educational institutions are included in the definition of a small business. However, we do not collect annual revenue data for ITFS licensees, and are not able to ascertain how many of the 100 non-educational licensees would be categorized as small under the SBA definition. Thus, we tentatively conclude that at least 1,932 are small businesses and may be affected by the established rules. 63. *Incumbent Local Exchange Carriers (“LECs”).* We have included small incumbent LECs in this present IRFA analysis. As noted above, a “small business” under the RFA is one that, *inter alia* , meets the pertinent small business size standard ( *e.g.* , a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. We have therefore included small incumbent local exchange carriers in this RFA analysis, although we emphasize that this RFA action has no effect on Commission analyses and determinations in other, non-RFA contexts. Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 1,303 carriers have reported that they are engaged in the provision of incumbent local exchange services. Of these 1,303 carriers, an estimated 1,020 have 1,500 or fewer employees and 283 have more than 1,500 employees. Consequently, the Commission estimates that most providers of incumbent local exchange service are small businesses that may be affected by our proposed rules. 64. *Competitive (LECs), Competitive Access Providers (CAPs), “Shared-Tenant Service Providers,” and “Other Local Service Providers.”* Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 769 carriers have reported that they are engaged in the provision of either competitive access provider services or competitive local exchange carrier services. Of these 769 carriers, an estimated 676 have 1,500 or fewer employees and 93 have more than 1,500 employees. In addition, 12 carriers have reported that they are “Shared-Tenant Service Providers,” and all 12 are estimated to have 1,500 or fewer employees. In addition, 39 carriers have reported that they are “Other Local Service Providers.” Of the 39, an estimated 38 have 1,500 or fewer employees and one has more than 1,500 employees. Consequently, the Commission estimates that most providers of competitive local exchange service, competitive access providers, “Shared-Tenant Service Providers,” and “Other Local Service Providers” are small entities that may be affected by our proposed rules. 65. *Satellite Telecommunications and Other Telecommunications.* The Commission has not developed a small business size standard specifically for providers of satellite service. The appropriate size standards under SBA rules are for the two broad categories of Satellite Telecommunications and Other Telecommunications. Under both categories, such a business is small if it has $12.5 million or less in average annual receipts. For the first category of Satellite Telecommunications, Census Bureau data for 1997 show that there were a total of 324 firms that operated for the entire year. Of this total, 273 firms had annual receipts of under $10 million, and an additional twenty-four firms had receipts of $10 million to $24,999,999. Thus, the majority of Satellite Telecommunications firms can be considered small. 66. The second category— *Other Telecommunications* —includes “establishments primarily engaged in * * * providing satellite terminal stations and associated facilities operationally connected with one or more terrestrial communications systems and capable of transmitting telecommunications to or receiving telecommunications from satellite systems.” Of this total, 424 firms had annual receipts of $5 million to $9,999,999 and an additional 6 firms had annual receipts of $10 million to $24,999,990. Thus, under this second size standard, the majority of firms can be considered small. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements 67. In this Second Report and Order, we have taken steps to advance our public safety mission by establishing a framework for the Next Generation of EAS and by expanding the base of EAS participants to include wireline telephone companies that provide programming in competition with broadcast and cable television. Steps Taken To Minimize the Significant Economic Impact on Small Entities, and Significant Alternatives Considered 68. The RFA requires an agency to describe any significant alternatives that it has considered in developing its approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;

(2)the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities;

(3)the use of performance rather than design standards; and

(4)an exemption from coverage of the rule, or any part thereof, for such small entities.” 69. The *First Report and Order and FNPRM* sought comment on a number of alternatives to the imposition of EAS obligations on the digital communications technologies discussed in this Second Report and Order that are increasingly being used by the American public. The Commission has considered each of the alternatives and in this Second Report and Order imposes minimal regulation on small entities to the extent consistent with our goal of advancing our public safety mission by adopting rules that expand the reach of EAS. The affected service providers have generally expressed their willingness to cooperate in a national warning system, and we anticipate that this addition of new providers to EAS can be accomplished swiftly and smoothly. 70. The benefits of requiring additional carriers to participate in the current EAS far outweigh any burdens associated with implementing these requirements. EAS represents a significant and valuable investment that is able to provide effective alert and warning during the time that new, digitally-based public alert and warning systems are being developed. Most commenters contend, and we agree, that the EAS should remain an important component of any future alert and warning system. Further, in most cases, the digital platforms affected by this Second Report and Order either have in place the ability to distribute EAS warnings, or can do so in a reasonable amount of time and with minimal cost. 71. Likewise, most commenters agreed that CAP is best-suited to deliver Next Generation EAS. By requiring EAS participants to adopt CAP, we believe that this will best serve our goal of protecting the life and property of all Americans. We acknowledge that compliance with the rules adopted in the order may impose cost burdens on small entities. However, given the great public interest benefits of the rules, we find that the public interest benefits outweigh the economic burdens, if any. In the Initial Regulatory Flexibility Analysis, we sought comment on these rules and no commenter proposed an alternative version that would serve these benefits while lessening the economic burdens. Accordingly, we find that we have discharged our duty to consider burdens imposed on small entities. 72. *Report to Congress:* The Commission will send a copy of the Second Report and Order, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act. In addition, the Commission will send a copy of the Second Report and Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the Second Report and Order and FRFA (or summaries thereof) will also be published in the **Federal Register** . III. Ordering Clauses 73. Accordingly, *it is ordered* , pursuant to sections 1, 2, 4(i), 4(o), 301, 303(r), 303(v), 307, 309, 335, 403, 624(g), 706 and 715 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i) and (o), 301, 303(r), 303(v), 307, 309, 335, 403, 544(g), 606, and 615, that the Second Report and Order in EB Docket No. 04-296 is adopted, and that part 11 of the Commission's rules, 47 CFR part 11, is amended. The Order shall become effective December 3, 2007, or 60 days after Congress's receipt of a Congressional Review Act report, whichever is later, except that new or modified information collection requirements will not become effective prior to OMB approval. 74. *It is further ordered* that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Second Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration. List of Subjects in 47 CFR Part 11 Radio, Television. Federal Communications Commission. Marlene H. Dortch, Secretary. Final Rules For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 11 as follows: PART 11—EMERGENCY ALERT SYSTEM

(EAS)1. The authority citation for part 11 continues to read as follows: Authority: 47 U.S.C. 151, 154(i) and (o), 303(r), 544(g) and 606. 2. Section 11.1 is revised to read as follows: § 11.1 Purpose. This part contains rules and regulations providing for an Emergency Alert System (EAS). The EAS provides the President with the capability to provide immediate communications and information to the general public at the National, State and Local Area levels during periods of national emergency. The rules in this part describe the required technical standards and operational procedures of the EAS for analog AM, FM, and TV broadcast stations, digital broadcast stations, analog cable systems, digital cable systems, wireline video systems, wireless cable systems, Direct Broadcast Satellite

(DBS)services, Satellite Digital Audio Radio Service (SDARS), and other participating entities. The EAS may be used to provide the heads of State and local government, or their designated representatives, with a means of emergency communication with the public in their State or Local Area. 3. Add § 11.2 to read as follows: § 11.2 Definitions. The definitions of terms used in part 11 are:

(a)*Primary Entry Point

(PEP)System.* The PEP system is a nationwide network of broadcast stations and other entities connected with government activation points. It is used to distribute the EAN, EAT, and EAS national test messages and other EAS messages. FEMA has designated 34 of the nation's largest radio broadcast stations as PEPs. The PEPs are designated to receive the Presidential alert from FEMA and distribute it to local stations.

(b)*Local Primary One (LP-1).* The LP-1 is a radio station that acts as a key EAS monitoring source. Each LP-1 station must monitor its regional PEP station and a back-up source for Presidential messages.

(c)*EAS Participants.* Entities required under the Commission's rules to comply with EAS rules, *e.g.* , analog radio and television stations, and wired and wireless cable television systems, DBS, DTV, SDARS, digital cable and DAB, and wireline video systems.

(d)*Wireline Video System.* The system of a wireline common carrier used to provide video programming service.

(e)*Participating National (PN).* PN stations are broadcast stations that transmit EAS National, state, or local EAS messages to the public.

(f)*National Primary (NP).* Stations that are the primary entry point for Presidential messages delivered by FEMA. These stations are responsible for broadcasting a Presidential alert to the public and to State Primary stations within their broadcast range.

(g)*State Primary (SP).* Stations that are the entry point for State messages, which can originate from the Governor or a designated representative. 4. Section 11.11 is amended by revising paragraph

(a)and

(e)to read as follows: § 11.11 The Emergency Alert System (EAS).

(a)The EAS is composed of analog radio broadcast stations including AM, FM, and Low-power FM

(LPFM)stations; digital audio broadcasting

(DAB)stations, including digital AM, FM, and Low-power FM stations; analog television broadcast stations including Class A television

(CA)and Low-power TV

(LPTV)stations; digital television

(DTV)broadcast stations, including digital CA and digital LPTV stations; analog cable systems; digital cable systems which are defined for purposes of this part only as the portion of a cable system that delivers channels in digital format to subscribers at the input of a Unidirectional Digital Cable Product or other navigation device; wireline video systems; wireless cable systems which may consist of Broadband Radio Service (BRS), or Educational Broadband Service

(EBS)stations; DBS services, as defined in 47 CFR 25.701(a) (including certain Ku-band Fixed-Satellite Service Direct to Home providers); SDARS, as defined in 47 CFR 25.201; participating broadcast networks, cable networks and program suppliers; and other entities and industries operating on an organized basis during emergencies at the National, State and local levels. These entities are referred to collectively as EAS Participants in this part, and are subject to this part, except as otherwise provided herein. At a minimum EAS Participants must use a common EAS protocol, as defined in § 11.31, to send and receive emergency alerts in accordance with the effective dates listed above and in the following tables: Analog and Digital Broadcast Stations EAS equipment requirement AM & FM class A TV 4 Digital AM & FM TV DTV FM class D 1 LPTV 2 LPFM 3 Two-tone encoder 5 Y 6 Y 12/31/06 Y Y 12/31/06 N N N Y EAS decoder Y 1/1/97 Y 12/31/06 Y 1/1/97 Y 12/31/06 Y 1/1/97 Y 1/1/97 Y Y EAS encoder Y 1/1/97 Y 12/31/06 Y 1/1/97 Y 12/31/06 N N N Y Audio message Y 1/1/97 Y 12/31/06 Y 1/1/97 Y 12/31/06 Y 1/1/97 Y 1/1/97 Y Y Video message N/A N/A Y 1/1/97 Y 12/31/06 N/A Y 1/1/97 N/A Y 1 Effective December 31, 2006, digital FM Class D stations have the same requirements. 2 LPTV stations that operate as television broadcast translator stations are exempt from the requirement to have EAS equipment. Effective December 31, 2006, digital LPTV stations have the same requirements. 3 LPFM stations must install a decoder within one year after the FCC publishes in the Federal Register a public notice indicating that at least one decoder has been certified by the FCC. Effective December 31, 2006, digital LPFM stations have the same requirements. 4 Effective December 31, 2006, digital Class A TV stations have the same requirements. 5 Effective July 1, 1995, the two-tone signal must be 8-25 seconds. 6 Effective January 1, 1998, the two-tone signal may only be used to provide audio alerts to audiences before EAS emergency messages and the required monthly tests. Analog Cable Systems [A. Analog cable systems serving fewer than 5,000 subscribers from a headend must either provide the National level EAS message on all programmed channels including the required testing by October 1, 2002, or comply with the following EAS requirements. All other analog cable systems must comply with B.] System Size and Effective Dates B. EAS equipment requirement ≥5,000 but < 10,000 subscribers ≥10,000 subscribers <5,000 subscribers Two-tone signal from storage device 1 Y 12/31/98 Y 10/1/02 Y 10/1/02 EAS decoder 3 Y 12/31/98 Y 10/1/02 Y 10/1/02 EAS encoder 2 Y 12/31/98 Y 10/1/02 Y 10/1/02 Audio and Video EAS Message on all channels Y 12/31/98 Y 10/1/02 N Video interrupt and audio alert message on all channels, 3 Audio and Video EAS message on at least one channel N N Y 10/1/02 1 Two-tone signal is only used to provide an audio alert to audience before EAS emergency messages and required monthly test. The two-tone signal must be 8-25 seconds in duration. 2 Analog cable systems serving <5,000 subscribers are permitted to operate without an EAS encoder if they install an FCC-certified decoder. 3 The Video interrupt must cause all channels that carry programming to flash for the duration of the EAS emergency message. The audio alert must give the channel where the EAS messages are carried and be repeated for the duration of the EAS message. Note: Programmed channels do not include channels used for the transmission of data such as interactive games. Wireless Cable Systems (BRS/EBS STATIONS) [A. Wireless cable systems serving fewer than 5,000 subscribers from a single transmission site must either provide the National level EAS message on all programmed channels including the required testing by October 1, 2002, or comply with the following EAS requirements. All other wireless cable systems must comply with B.] System Size and Effective Dates B. EAS equipment requirement ≥5,000 subscribers <5,000 subscribers EAS decoder Y 10/1/02 Y 10/1/02 EAS encoder 1 2 Y 10/1/02 Y 10/1/02 Audio and Video EAS Message on all channels 3 Y 10/1/02 N Video interrupt and audio alert message on all channels; 4 Audio and Video EAS message on at least one channel N Y 10/1/02 1 The two-tone signal is used only to provide an audio alert to an audience prior to an EAS emergency message or to the Required Monthly Test

(RMT)under § 11.61(a)(1). The two-tone signal must be 8-25 seconds in duration. 2 Wireless cable systems serving <5,000 subscribers are permitted to operate without an EAS encoder if they install an FCC-certified decoder. 3 All wireless cable systems may comply with this requirement by providing a means to switch all programmed channels to a predesignated channel that carries the required audio and video EAS messages. 4 The Video interrupt must cause all channels that carry programming to flash for the duration of the EAS emergency message. The audio alert must give the channel where the EAS messages are carried and be repeated for the duration of the EAS message. Note: Programmed channels do not include channels used for the transmission of data services such as Internet. Digital Cable Systems and Wireline Video Systems [A. Digital cable systems and Wireline Video Systems serving fewer than 5,000 subscribers from a headend must either provide the National level EAS message on all programmed channels including the required testing by December 31, 2006, or comply with the following EAS requirements. All other digital cable systems and Wireline Video Systems must comply with B.] System Size and Effective Dates B. EAS equipment requirement ≥5,000 subscribers <5,000 subscribers Two-tone signal from storage device 1 Y 12/31/06 Y 12/31/06 EAS decoder 3 Y 12/31/06 Y 12/31/06 EAS encoder 2 Y 12/31/06 Y 12/31/06 Audio and Video EAS Message on all channels 4 Y 12/31/06 N Video interrupt and audio alert message on all channels 3 Audio and Video EAS message on at least one channel N Y 12/31/06 1 Two-tone signal is only used to provide an audio alert to audience before EAS emergency messages and required monthly test. The two-tone signal must be 8-25 seconds in duration. 2 Digital cable systems and Wireline Video Systems serving <5,000 subscribers are permitted to operate without an EAS encoder if they install an FCC-certified decoder. 3 The Video interrupt must cause all channels that carry programming to flash for the duration of the EAS emergency message. The audio alert must give the channel where the EAS messages are carried and be repeated for the duration of the EAS message. 4 All digital cable systems and/Wireline Video Systems may comply with this requirement by providing a means to switch all programmed channels to a predesignated channel that carries the required audio and video EAS messages. Note: Programmed channels do not include channels used for the transmission of data such as interactive games or the transmission of data services such as Internet. SDARS and DBS EAS equipment requirement SDARS DBS Two-tone signal 1 Y 12/31/06 Y 5/31/07 EAS decoder Y 12/31/06 Y 5/31/07 EAS encoder Y 12/31/06 Y 5/31/07 Audio message on all channels 2 Y 12/31/06 Y 5/31/07 Video message on all channels 2 N/A Y 5/31/07 1 Two-tone signal is only used to provide an audio alert to audience before EAS emergency messages and required monthly test. The two-tone signal must be 8-25 seconds in duration. 2 All SDARS and DBS providers may comply with this requirement by providing a means to switch all programmed channels to a predesignated channel that carries the required audio and video EAS messages or by any other method that ensures that viewers of all channels receive the EAS message.

(e)Other technologies and public service providers, such as low earth orbiting satellites, that wish to participate in the EAS may contact the FCC's Public Safety and Homeland Security Bureau or their State Emergency Communications Committee for information and guidance. 5. Section 11.21 is revised to read as follows: § 11.21 State and Local Area Plans and FCC Mapbook. EAS plans contain guidelines which must be followed by EAS Participants' personnel, emergency officials, and National Weather Service

(NWS)personnel to activate the EAS. The plans include the EAS header codes and messages that will be transmitted by key EAS sources (NP, LP, SP and SR). State and local plans contain unique methods of EAS message distribution such as the use of the Radio Broadcast Data System (RBDS). The plans must be reviewed and approved by the Chief, Public Safety and Homeland Security Bureau, prior to implementation to ensure that they are consistent with national plans, FCC regulations, and EAS operation.

(a)The State plan contains procedures for State emergency management and other State officials, the NWS, and EAS Participants' personnel to transmit emergency information to the public during a State emergency using the EAS, including mandatory messages initiated by a state governor or his/her designee. The State plan must specify how state-level and geographically targeted EAS messages initiated by a state governor or his/her designee will be transmitted to all EAS Participants who provide services in the state, and must include specific and detailed information describing how such messages will be aggregated, designated as mandatory, and delivered to EAS Participants. State EAS plans should include a data table, in computer readable form, clearly showing monitoring assignments and the specific primary and backup path for the emergency action notification (“EAN”) from the PEP to each station in the plan.

(b)The Local Area plan contains procedures for local officials or the NWS to transmit emergency information to the public during a local emergency using the EAS. Local plans may be a part of the State plan. A Local Area is a geographical area of contiguous communities or counties that may include more than one state.

(c)The FCC Mapbook is based on the above plans. It organizes all broadcast stations and cable systems according to their State, EAS Local Area, and EAS designation. 6. Section 11.47 is amended by revising paragraph

(b)to read as follows: § 11.47 Optional use of other communications methods and systems.

(b)Other technologies and public service providers, such as low earth orbiting satellites, that wish to participate in the EAS may contact the FCC's Public Safety and Homeland Security Bureau or their State Emergency Communications Committee for information and guidance. § 11.51 EAS code and Attention Signal Transmission requirements. 7. Section 11.51 is amended by revising paragraphs

(g)introductory text and

(h)introductory text to read as follows:

(g)Analog cable systems and digital cable systems with fewer than 5,000 subscribers per headend and wireline video systems and wireless cable systems with fewer than 5,000 subscribers shall transmit EAS audio messages in the same order specified in paragraph

(a)of this section on at least one channel. The Attention signal may be produced from a storage device. Additionally, these analog cable systems, digital cable systems, and wireless cable systems:

(h)Analog cable systems and digital cable systems with 10,000 or more subscribers; analog cable and digital cable systems serving 5,000 or more, but less than 10,000 subscribers per headend; and wireline video systems and wireless cable systems with 5,000 or more subscribers shall transmit EAS audio messages in the same order specified in paragraph

(a)of this section. The Attention signal may be produced from a storage device. Additionally, these analog cable systems, digital cable systems, and wireless cable systems: 8. Section 11.55 is amended by revising paragraph

(a)introductory text to read as follows: § 11.55 EAS operation during a State or Local Area emergency.

(a)All EAS Participants within a state (excepting SDARs and DBS providers) must receive and transmit state-level and geographically targeted EAS messages, as aggregated and delivered by the state governor or his/her designee, or by FEMA on behalf of such state governor, upon approval by the Commission of an applicable state plan providing for delivery of such alerts no sooner than 180 days after adoption of CAP by FEMA. Examples of natural emergencies which may warrant activation are: Tornadoes, floods, hurricanes, earthquakes, heavy snows, icing conditions, widespread fires, etc. Man-made emergencies may include: toxic gas leaks or liquid spills, widespread power failures, industrial explosions, and civil disorders. 9. Add § 11.56 to read as follows: § 11.56 EAS Participants receive CAP-formatted alerts Notwithstanding anything herein to the contrary, all EAS Participants must be able to receive CAP-formatted EAS alerts no later than 180 days after FEMA publishes the technical standards and requirements for such FEMA transmissions. [FR Doc. E7-21137 Filed 11-1-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 571 and 585 [Docket No. NHTSA 2007-0010] RIN 2127-AK03 Federal Motor Vehicle Safety Standards; Occupant Crash Protection; Fuel System Integrity AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION: Final rule; response to petitions. SUMMARY: In a final rule published in August 2006, NHTSA amended its safety standard on occupant crash protection to establish the same 56 km/h (35 mph) maximum speed for frontal barrier crash tests using belted 5th percentile adult female test dummies as it had previously adopted for tests using belted 50th percentile adult male dummies. The agency adopted the amendment to help improve crash protection for small statured occupants. In this document, in response to petitions for reconsideration of that rule, we are adjusting the phase-in requirements to permit manufacturers to earn advance credits for vehicles that are certified in compliance with the new higher speed requirement one year in advance of the regulatory requirements, *i.e.* , beginning on September 1, 2008. We are also making technical corrections regarding special phase-in provisions for small volume manufacturers included in the August 2006 rule, as well as in several other regulations. DATES: *Effective Date:* This final rule is effective January 2, 2008. *Petitions for Reconsideration:* If you wish to submit a petition for reconsideration of this rule, your petition must be received by December 17, 2007. ADDRESSES: Petitions for reconsideration should refer to the docket number above and be submitted to: Administrator, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. See the SUPPLEMENTARY INFORMATION portion of this document (Section V; Rulemaking Analyses and Notice) for DOT's Privacy Act Statement regarding documents submitted to the agency's dockets. FOR FURTHER INFORMATION CONTACT: For non-legal issues, you may call Ms. Carla Cuentas, Office of Crashworthiness Standards (Telephone: 202-366-1740) (Fax: 202-366-2739). For legal issues, you may call Mr. Edward Glancy, Office of the Chief Counsel (Telephone: 202-366-2992) (Fax: 202-366-3820). You may send mail to these officials at National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Petitions for Reconsideration III. Request for Technical Corrections IV. Final Rule; Agency Response to Petitions V. Rulemaking Analyses and Notices I. Background Federal Motor Vehicle Safety Standard (FMVSS) No. 208, *Occupant Crash Protection,* requires passenger cars and other light vehicles to be equipped with seat belts and frontal air bags to prevent or mitigate the effects of occupant interaction with the vehicle's interior in a crash. While air bags have proven to be very effective in increasing the number of lives saved in moderate to high speed frontal crashes, they have on occasion been implicated in fatalities where vehicle occupants were in close proximity to the air bag when it deployed. The majority of these fatalities occurred in vehicles produced in the 1990s. On May 12, 2000, NHTSA published in the **Federal Register** (65 FR 30690) its advanced air bag final rule. This final rule required that future air bags be designed to create less risk of serious air bag-induced injuries. The original advanced air bag rule established two phase-in implementation schedules for the new requirements. Under Phase I, which began September 1, 2003 and was completed on September 1, 2006, NHTSA required vehicle manufacturers to install advanced air bag systems that reduce the risk of air bag-induced injuries (particularly to young children and small adult drivers), while improving the frontal crash protection provided by air bag systems to occupants of different sizes. NHTSA specified the use of both 50th percentile adult male and 5th percentile adult female dummies for the standard's crash tests. 1 Phase I required vehicles to be certified as passing the performance requirements for both of these dummies, while unbelted, in a 32 km/h (20 mph) to 40 km/h (25 mph) rigid barrier test (unbelted rigid barrier test requirements), and performance requirements for the same two dummies, while belted, in a rigid barrier crash test with a maximum test speed of 48 km/h (30 mph) (belted rigid barrier test requirements). 1 The advanced air bag rule also specified the use of 1-year-old infant dummies, 3- and 6-year old child dummies, and 5th percentile adult female dummies in its test requirements to minimize the risk to infants, children, and other occupants from injuries and deaths caused by air bags. Under Phase II, which begins to be phased-in on September 1, 2007, vehicles must be certified as passing the belted rigid barrier performance requirements at speeds up to and including 56 km/h (35 mph) using just the 50th percentile adult male dummy. In the original advanced air bag rulemaking, we stated that we did not propose including the 5th percentile adult female dummy in the second phase-in requirement because we “had sparse information on the practicability of such a requirement.” We also stated that the agency would undergo testing to examine this issue further and that we anticipated “proposing increasing the test speed for belted tests using the 5th percentile adult female dummy to 35 mph, beginning at the same time that the 50th percentile adult male is required to be used in belted testing at that speed.” (60 FR 20680, 30690; and 66 FR 65376). On August 6, 2003, we published a notice of proposed rulemaking

(NPRM)(68 FR 46539) to increase the test speed for the belted rigid barrier test using the 5th percentile adult female dummy to 56 km/h (35 mph). We proposed the same phase-in schedule as the one used in Phase II beginning September 1, 2007. In this NPRM, we tentatively concluded that the results of the tests conducted by NHTSA indicated both a need for and the feasibility of extending the 56 km/h (35 mph) maximum speed for the rigid barrier test to include the 5th percentile adult female dummy. On August 31, 2006, NHTSA published a final rule (71 FR 57168) increasing the maximum test speed for the belted rigid barrier test using the 5th percentile adult female dummy from 48 km/h (30 mph) to 56 km/h (35 mph), the same speed we had previously adopted for 50th percentile adult male dummies. After considering the public's comments, the agency continued to believe that the test data obtained indicated that FMVSS No. 208 should require the same level of high speed crash protection for small statured occupants as for larger occupants. We noted that the final rule was essentially the same as the proposal, except for the timing of the phase-in. Under the final rule, the new requirement was phased-in in a manner similar to the phase-in for the 56 km/h (35 mph) maximum speed test requirement using the 50th percentile adult male dummy, but with a beginning date two years later, *i.e.* , September 1, 2009. We stated that the additional leadtime would provide manufacturers the time needed to meet design challenges associated with some vehicles and incorporate these additional requirements into their product development schedules without undue consequences. We stated that given that this phase-in was two years later, and that many vehicles already comply with the new requirement, we were not including advance credits as part of this phase-in, although carryover credits earned during the phase-in would be allowed. The implementation schedule for the new requirement was as follows: —35 percent of each manufacturer's light vehicles manufactured during the production year beginning on September 1, 2009; —65 percent of each manufacturer's light vehicles manufactured during the production year beginning on September 1, 2010, with an allowance of carryover credits from vehicles built after September 1, 2009. —100 percent of each manufacturer's light vehicles manufactured during the production year beginning on September 1, 2011, with an allowance of carryover credits from vehicles built after September 1, 2009. —All light vehicles manufactured on or after September 1, 2012. Manufacturers that sell two or fewer carlines in the United States at the beginning of the first year of the phase-in (September 1, 2009) have the option of omitting the first year of the phase-in, if they fully comply beginning on September 1, 2010. Manufacturers that produce or assemble fewer than 5,000 vehicles for the U.S. market per year may defer compliance with the new requirement until September 1, 2012. Consistent with our usual policy concerning multi-stage vehicles, multi-stage manufacturers and alterers may defer compliance with the new requirement until September 1, 2013. II. Petitions for Reconsideration The agency received petitions for reconsideration of the August 2006 final rule from the following vehicle manufacturers and manufacturer organization: Porsche Cars North America, Inc. (Porsche), Volkswagen of America, Inc. (VW), Mitsubishi Motors R&D of America (Mitsubishi), and Alliance of Automobile Manufacturers (Alliance). All four of the petitioners asked that we reconsider our decision not to include advance credits as part of the phase-in. Two of the petitioners, Alliance and VW, requested a technical correction in the regulatory text of the standard regarding a special phase-in provision for small volume manufacturers. The details of the requests of the petitioners, and our response, are provided below. III. Request for Technical Corrections The agency received a letter, dated March 29, 2007, from VW, requesting technical corrections in the regulatory text of FMVSS No. 301, *Fuel System Integrity,* and Part 585, *Phase-in Reporting Requirements.* While the letter addresses different regulatory requirements than the petitions for reconsideration discussed above, it requests technical corrections regarding special phase-in provisions for small volume manufacturers that are essentially the same. We are therefore addressing these technical corrections in this document. IV. Final Rule; Agency Response to Petitions As discussed below, in response to petitions for reconsideration of the August 2006 final rule increasing the speed of the frontal barrier test requirement using belted 5th percentile adult female dummies, we are adjusting the phase-in requirements to permit manufacturers to earn advance credits for vehicles that are certified in compliance with the new higher speed requirement one year in advance of the regulatory requirements, *i.e.* , beginning on September 1, 2008. We are also making technical corrections regarding special phase-in provisions for small volume manufacturers included in the August 2006 rule, as well as in several other regulations. A. Advance Credits As noted above, the August 2006 final rule did not include advance credits as part of the phase-in of the 56 km/h (35 mph) barrier crash test requirements using belted 5th percentile adult female dummies, although carryover credits earned during the phase-in were permitted. The lack of advance credits for early compliance prior to the beginning of the phase-in period differed from the allowance for early credits provided in the original advanced air bag rule (See FMVSS No. 208 S14.1.2), which permitted credits for vehicles produced on or after June 12, 2000, for the purposes of complying with the advanced air bag requirements for which the phase-in began September 1, 2003. Also, the original advanced air bag rule provided for advance carry-forward credits for vehicles produced on or after September 1, 2006, for the purposes of the 35 mph crash test requirements using the 50th percentile male dummy that will begin to be phased in on September 1, 2007 (See FMVSS No. 208 S14.3.2). The agency stated that it was not including advance credits as part of the phase-in of the 56 km/h (35 mph) requirements using the 5th percentile adult female dummy given that this phase-in was two years later, and that many vehicles already comply with the new requirement. As indicated earlier, the Alliance, Mitsubishi, Porsche and VW asked that we reconsider our decision not to include advance credits as part of the phase-in. Petitions The Alliance asked us to permit manufacturers to earn and apply advance carry-forward credits for vehicles that can be certified in compliance with the new requirements two years in advance of the regulatory requirements. It stated that this is an unusually unstable era in the U.S. automotive industry, and that in the current economy the uncertainties associated with making product plans and compliance projections for a phased-in rule are very high, creating the need for maximum flexibility in designing new regulatory requirements. That organization stated that it recognizes that providing advance carry-forward credits for early compliance with safety standards is unusual. It noted, however, that advance carry-forward credits for early compliance were included in the original advanced air bag rule, including for early compliance with the 56 km/h (35 mph) crash test requirements using the 50th percentile adult male dummy that will begin to be phased in on September 1, 2007. It also stated that providing advance credits would be consistent with Congressional intent in enacting the advanced air bag requirements, as the Transportation Equity Act for the 21st Century requirements for advanced air bags had provided for such credits. The Alliance questioned the agency's statement that many vehicles already comply with the new rules, arguing that the rulemaking record shows mixed test results. It stated that the record showed that 12 vehicle models “already comply” with the new rules, while 6 did not. The Alliance also stated that none of the 12 models were certified to the advanced air bag requirements, so it is unclear whether any would comply with an adequate margin of compliance after an advanced air bag is installed, given the design and performance tradeoffs that are required for advanced air bags. The Alliance also noted that the agency had conducted additional testing of five more vehicle models that were certified to the advanced air bag requirements, and all met the 35 mph crash test requirement with the 5th percentile female dummy, although one had no compliance margin. The Alliance argued that the record reflects the difficulties of redesigning air bags to meet the competing demands of protecting large adult males, both belted and unbelted; protecting small females, both belted and unbelted; and protecting children, both restrained and unrestrained. According to the Alliance, adding the 35 mph barrier crash test for the 5th percentile female dummy complicates this design task even further, emphasizing the need for flexibility during the phase-in. The Alliance argued that advance carry-forward credits are positive for safety, because they recognize and reward manufacturers that are able to certify compliance with the new requirements earlier than they otherwise would have to. It also stated that the availability of advance carry-forward credits acts as an incentive to manufacturers to make the commitment to assuring compliance that is necessary to earn and claim advance carry-forward credits. It also stated that at the end of the phase-in, the same number of vehicles will be certified as compliant whether or not the advance carry-forward credits were made available—but the advance carry-forward credits would incentivize manufacturers to bring more vehicles into compliance earlier. According to the Alliance, given the dynamic nature of the U.S. auto industry, despite manufacturers' best efforts to project compliant fleets during the phase-in, it may become critically necessary to use advance carry-forward credits to achieve compliance, if sales for certain models fall short of projections and as manufacturers respond to fluctuations in market demand. For all of these reasons, the Alliance requested that the agency permit manufacturers to earn and apply advance carry-forward credits for vehicles that can be certified in compliance with the new requirements two years in advance of the regulatory requirements. VW, Mitsubishi and Porsche made requests similar to that of the Alliance. Like the Alliance, VW requested that manufacturers be permitted to earn advance credits for vehicles that are produced beginning September 1, 2007, i.e., two years in advance of the regulatory requirements. Mitsubishi requested that manufacturers be permitted to earn advance credits for one production year prior to the phase-in, i.e., beginning September 1, 2008. Porsche requested that the agency either provide manufacturers the opportunity to generate advance credits for vehicles built one year prior to the start of the phase-in schedule, or reduce the compliance requirement for the first year of the phase-in from 35 percent to 20 percent. Mitsubishi and Porsche noted that the final rule was issued three years after the proposal and argued that even with the two-year later phase-in, advance credits are still needed. Mitsubishi and Porsche each provided information subject to claims of confidentiality in support of their petitions. Agency Response After carefully considering the requests of the petitioners, we have decided to permit manufacturers to earn advance credits for vehicles that are certified in compliance with the new 56 km/h (35 mph) barrier requirements using the belted 5th percentile adult female dummy one year in advance of the regulatory requirements, i.e., beginning on September 1, 2008. As the Alliance noted in its petition, providing advance carry-forward credits for early compliance with safety standards is unusual but not without precedent. We note that a provision for advance credits can act as an incentive for early introduction of new safety technologies and provide additional flexibility for manufacturers while resulting in the same number of vehicles certified to meet new requirements prior to full, 100 percent implementation. On the other hand, we also recognize that advance credits can reduce the number of vehicles that need to be upgraded to comply with a new requirement during the actual production years covered by a phase-in, particularly in situations where many vehicles may already comply with the requirement. In the NPRM to increase the test speed of the barrier requirements using the belted 5th percentile adult female dummy, we proposed to permit manufacturers to earn advance credits for one year prior to the beginning of the phase-in. For the final rule, we did not include this provision. We believed that the provision was unnecessary, given that we adopted a phase-in that began two years later than we had proposed. On reconsideration, we have decided to include a provision permitting manufacturers to earn advance credits for one year prior to the beginning of the phase-in. After considering the comments, we are persuaded that this additional flexibility is appropriate. This one-year period for earning advance credits is consistent with the Phase II phase-in, as well as the NPRM for this Phase III requirement. Among other things, this provision will provide flexibility to manufacturers in dealing with uncertainty in projecting sales volumes of different models as they plan to meet the percentage phase-in requirements. We are not, however, providing the longer, two-year period requested by the Alliance and VW. Neither petitioner provided data or specific arguments demonstrating the need for a period as long as two years or that a one-year period is not sufficient. The issues raised by the Alliance about the need for flexibility were of a general nature, and we believe that those concerns are addressed by the one-year period we are adopting. VW cited the fact that the period for advance credits was longer for Phase I, and a statement by the agency in the original advanced air bag rulemaking that we were only allowing credits to be earned for vehicles manufactured one year prior to the initiation of the Phase II requirements because we believed manufacturers should first direct their efforts toward full implementation of Phase I, particularly the risk reduction requirements. While we agree that the Phase I implementation is not affected by Phase III, we decline to adopt a period longer than one year. As indicated above, a provision for advance credits can act as an incentive for early introduction of new safety technologies and provide additional flexibility for manufacturers, but can also reduce the number of vehicles that need to be upgraded to comply with a new requirement during the actual production years covered by a phase-in, particularly in situations where many vehicles may already comply with the requirement. In balancing these considerations, we conclude that a one-year period for earning advance credits for Phase III is appropriate. We note that we do not know how many vehicles already comply with the requirements. However, as discussed in the preamble to the final rule, and noted by the Alliance, the agency conducted testing of five vehicle models that were certified to the advanced air bag requirements, and all met the 56 km/h (35 mph) crash test requirement with the 5th percentile female dummy, although one had no compliance margin. This suggests that a significant number of vehicles already comply. We also note that the primary purpose of a provision for advance credits is to provide an incentive to encourage manufacturers to develop and introduce new technologies earlier than they would otherwise be required. While manufacturers needed to develop and introduce new technologies to meet the risk reduction requirements of the Phase I advance air bag requirements, we believe that was generally not the case for either Phase II or Phase III. This is another reason not to provide a longer period for advance credits. We note that we are making conforming changes to part 585, *Phase-in Reporting Requirements,* to reflect the provision for advance credits. B. Phase-In Exclusion for Small Volume Manufacturers In the preamble of the August 2006 final rule, NHTSA stated that manufacturers that produce or assemble fewer than 5,000 vehicles for the U.S. market per year may defer compliance until September 1, 2012. 71 FR 51770. This is consistent with similar provisions in FMVSS No. 208 S14.1(d) (related to Phase I) and S14.3(d) (related to Phase II) in which the limit of 5,000 vehicles applies toward production for the U.S. market and not worldwide production. However, in the regulatory text of the August 2006 final rule, S14.6(d) read: “Vehicles that are manufactured by a manufacturer that produces fewer than 5,000 vehicles world-wide annually are not subject to the requirements of S14.6.” In their petitions for reconsideration, the Alliance and VW pointed out this discrepancy and their belief that the agency intended to implement this provision as described in the preamble. We confirm that the regulatory text in S14.6(d) was incorrect and are revising it to be consistent with the preamble, and with the regulatory text at S14.1(d) and S14.3(d). It will now read: “Vehicles that are manufactured by an original vehicle manufacturer that produces or assembles fewer than 5,000 vehicles annually for sale in the United States are not subject to the requirements of S14.6.” As indicated above, we received a letter, dated March 29, 2007, from VW, requesting technical corrections in the regulatory text of FMVSS No. 301, *Fuel System Integrity,* and part 585, *Phase-in Reporting Requirements* . While the request addresses different regulatory requirements than the petitions for reconsideration discussed above, it requests technical corrections regarding special phase-in provisions for small volume manufacturers that are essentially the same. We are therefore addressing these issues in this final rule. 2 2 We note that Lance Tunick separately identified to the agency the discrepancies related to the FMVSS No. 208 requirement increasing the test speed using belted 5th percentile adult female dummies and also the requirement related to FMVSS No. 301. Specifically, with respect to the phase-in of inboard rear seat lap/shoulder requirements of FMVSS No. 208, VW noted a similar discrepancy between the preamble/regulatory text of FMVSS No. 208 (which are consistent) and the relevant regulatory text of Part 585. Also, with respect to the phase-in of upgraded rear crash test requirements in FMVSS No. 301, VW noted a similar discrepancy between the preamble and the regulatory text in FMVSS No. 301, and the lack of a corresponding provision in Part 585. In each of these instances, the agency intended, as indicated in the preamble, to apply the different compliance date to manufacturers that produce or assemble fewer than 5,000 vehicles for the U.S. market each year. We are therefore making technical corrections along the lines requested by VW. V. Rulemaking Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures NHTSA has considered the impacts of this rulemaking action under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under E.O. 12866. This rule amends the agency's August 2006 final rule that upgraded FMVSS No. 208 to increase the maximum belted frontal barrier crash test speed from 48 km/h (30 mph) to 56 km/h (35 mph) for the 5th percentile adult female dummy. This is the same test speed as is specified for the 50th percentile adult male dummy. The August 2006 final rule was considered significant because of public interest. However, as explained below, today's amendments are not significant. As discussed in the preamble to the August 2006 final rule, the agency estimated that the rule will prevent 2-4 fatalities and reduce 2 MAIS 2-5 non-fatal injuries. The total net cost could range from $0.0 to $9.0 million (2004 economics). The agency estimated the total cost of that rule will most likely be $4.5 million. This rule amends the phase-in requirements of the August 2006 final rule to permit manufacturers to earn advance credits for vehicles that are certified in compliance with the new higher speed requirement one year in advance of the regulatory requirements, i.e., beginning on September 1, 2008. It does not change the number of vehicles that must be certified to the new requirements, nor does it change the dates or percentage requirements of the phase-in. Accordingly, while the rule provides some additional flexibility for manufacturers, it does not affect costs and benefits in a manner that is quantifiable. Moreover, for the same reason, it is not necessary for the agency to do a separate regulatory evaluation. B. Regulatory Flexibility Act NHTSA has considered the effects of this rulemaking action under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). NHTSA has determined that this action will not have a significant economic impact on a substantial number of small entities. In the preamble to the August 2006 final rule, NHTSA made a determination that that rule will not have a significant economic impact on a substantial number of small entities. Today's amendments make a small adjustment in the phase-in requirements of that rule in a manner that provides greater flexibility. Since these amendments will not significantly affect small entities, this rule will not have a significant economic impact on a substantial number of small entities. C. National Environmental Policy Act NHTSA has analyzed the final rule for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action will not have any significant impact on the quality of the human environment. D. Executive Order 13132 (Federalism) NHTSA has examined today's final rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the rule does not have federalism implications because the rule does not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Further, no consultation is needed to discuss the preemptive effect of today's rule. NHTSA rules can have preemptive effect in at least two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemptive provision: “When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter.” 49 U.S.C. 30103(b)(1). It is this statutory command that preempts State law, not today's rulemaking, so consultation would be inappropriate. In addition to the express preemption noted above, the Supreme Court has also recognized that State requirements imposed on motor vehicle manufacturers, including sanctions imposed by State tort law, can stand as an obstacle to the accomplishment and execution of a NHTSA safety standard. When such a conflict is discerned, the Supremacy Clause of the Constitution makes the State requirements unenforceable. See *Geier* v. *American Honda Motor Co.,* 529 U.S. 861 (2000). E. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995

(UMRA)requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year ($120,700,000 as adjusted for inflation with base year of 1995). Because this final rule will not have a $100 million effect, no Unfunded Mandates assessment has been prepared. F. Executive Order 12988 (Civil Justice Reform) With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729, February 7, 1996) requires that Executive agencies make every reasonable effort to ensure that the regulation:

(1)Clearly specifies the preemptive effect;

(2)clearly specifies the effect on existing Federal law or regulation;

(3)provides a clear legal standard for affected conduct, while promoting simplification and burden reduction;

(4)clearly specifies the retroactive effect, if any;

(5)adequately defines key terms; and

(6)addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement. Pursuant to this Order, NHTSA notes as follows. The preemptive effect of this rule is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court. G. Paperwork Reduction Act Under the procedures established by the Paperwork Reduction Act of 1995, a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This final rule contains a “collection of information” as that term is defined by OMB at 5 CFR 1320. As a result of this final rule, NHTSA proposes to amend an existing collection of information as follows: *Agency:* National Highway Traffic Safety Administration (NHTSA). *Title:* Part 585—Advanced Air Bag Phase-In Reporting Requirements. *Type of Request* —Revision of a Currently Approved Collection of Information. *OMB Clearance No.* —2127-0599. *Form Number* —This collection of information will not use any standard forms. *Total Annual Responses* —21. *Total Annual Burden Hours* —1,260. *Total Annual Burden Dollars* —$0. *Requested Expiration Date of Clearance* —At present, Clearance No. 2127-0599 is scheduled to expire on April 30, 2010. NHTSA will ask for one more extension of this collection of information—through October 31, 2012. Summary of the Collection of Information In the “Rulemaking Analyses and Notices” section of the August 31, 2006 final rule, NHTSA discussed the Paperwork Reduction Act consequences of the collection of information ( *See* 71 FR at 51776-51777). As a result of today's final rule, NHTSA proposes to amend its description of the collection of information as follows. As earlier described, in today's final rule, we are providing a year in which manufacturers can earn advance credits for compliance with the 56 km/h (35 mph) requirements using the 5th percentile adult female dummy. Phase-in Reporting The phase-in of the 56 km/h (35 mph) maximum test speed for the belted rigid barrier test using the 5th percentile adult female dummy is similar to the one for the test using the 50th percentile adult male dummy, except that it is two years later. Under today's rule, manufacturers will be able to earn advance credits for vehicles that are certified in compliance with the new higher speed requirement one year in advance of the regulatory requirements, i.e., beginning on September 1, 2008. The implementation schedule for the phase-in of the higher speed requirement using the 5th percentile adult female dummy, as revised by today's rule, is as follows: —Advance credits for each manufacturer's light vehicles certified in compliance with the new higher speed requirement that were manufactured during the production year beginning on September 1, 2008 (with the phase-in report to NHTSA due on October 31, 2009). —35 percent of each manufacturer's light vehicles manufactured during the production year beginning on September 1, 2009, with an allowance of carryover credits (with the phase-in report to NHTSA due on October 31, 2010). —65 percent of each manufacturer's light vehicles manufactured during the production year beginning on September 1, 2010, with an allowance of carryover credits (with the phase-in report to NHTSA due on October 31, 2011). —100 percent of each manufacturer's light vehicles manufactured during the production year beginning on September 1, 2011, with an allowance of carryover credits (with the phase-in report to NHTSA due on October 31, 2012). —All light vehicles manufactured on or after September 1, 2012. Manufacturers that sell two or fewer carlines in the United States at the beginning of the first year of the phase-in (September 1, 2009), have the option of omitting the first year of the phase-in, if they fully comply beginning on September 1, 2010. Manufacturers that produce or assemble fewer than 5,000 vehicles for the U.S. market per year may defer compliance with the new requirement until September 1, 2012. Description of the Need for the Use of the Information NHTSA needs this information to ensure that vehicle manufacturers are certifying their applicable vehicles as meeting the new belted barrier test using the 5th percentile female. NHTSA will use this information to determine whether a manufacturer has complied with the amended requirements of FMVSS No. 208 during the phase-in period. Description of the Likely Respondents (Including Estimated Number, and Proposed Frequency of Response to the Collection of Information) NHTSA estimates that 21 vehicle manufacturers will submit the required information. For each report, the manufacturer will provide, in addition to its identity, several numerical items of information. The information includes:

(a)Total number of vehicles manufactured for sale during the preceding production year,

(b)Total number of vehicles manufactured during the production year that meet the regulatory requirements, and

(c)Information identifying the vehicles (by make, model, and vehicle identification number (VIN)) that have been certified as complying with the belted barrier test upgrade. Estimate of the Total Annual Reporting and Recordkeeping Burden Resulting From the Collection of Information At present, OMB Clearance No. 2127-0599 gives NHTSA approval to collect 1,281 burden hours a year from industry, or 61 hours from each of 21 manufacturers. This figure of 61 hours represents the burden hours that would result if reports for two separate but related phase-ins were due the same year, *e.g.* , both the higher speed test requirement using 50th percentile adult male test dummies and the higher speed test requirement using the 5th percentile adult female dummies. In the event that manufacturers must provide only one phase-in report in a given year, the collection of information burden would be 60 hours per manufacturer, or a total collection of information burden on industry of 1,260 hours. Approved Clearance Through April 30, 2010 For the report due on October 31, 2008 (covering vehicles manufactured during the production year beginning on September 1, 2007), since only the phase-in report for the 50th percentile adult male test dummies must be provided, NHTSA estimates that each manufacturer will incur 60 burden hours per year, or a total collection of information burden on industry of 1,260 hours. For the report due on October 31, 2009 (covering vehicles manufactured during the production year beginning on September 1, 2008), this will be the first year for which manufacturers may need to report on vehicles certified in compliance with the higher speed 5th percentile adult female dummy requirements, if they choose to earn advance credits. In addition, for all vehicle manufacturers, the phase-in reports for the 50th percentile adult male dummies must continue to be provided. Thus, assuming all manufacturers provide both reports, NHTSA estimates that each manufacturer will incur 61 burden hours a year, for a total of 1,281 hours a year. This estimate is based on the fact that the reporting format for the test requirements using both the 50th percentile adult male test dummies and the 5th percentile adult female test dummies is identical. The data collection will involve only computer tabulation (using the same reporting format) and manufacturers will provide the information to NHTSA in an electronic (as opposed to paper) format. The data will cover the same types of vehicles for both upgrades of the belted barrier test. Anticipated Request for Clearance for October 31, 2010 Through October 31, 2012 The first year of the phase-in for the higher speed test requirement using 5th percentile adult female dummies covers the production period from September 1, 2009, through August 31, 2010. The report will be due by October 31, 2010, a time after OMB Clearance No. 2127-0599 expires on April 10, 2010. According to the phase-in schedule specified in the final rule of August 31, 2006, the three year period from October 31, 2009, through October 31, 2012, will include one year (covering the production period from September 1, 2009, through August 31, 2010) when manufacturers will report on both the last year of the phase-in for the higher speed test requirement using 50th percentile adult male test dummies and the first year of the higher speed test requirement using 5th percentile adult female dummies. For this one year, there will be an increase of one burden hour, resulting in a total of 61 burden hours per manufacturer, or a total burden of 1,281 hours on industry. This estimate is based on the fact that the reporting format for the test requirements using both the 50th percentile adult male test dummies and the 5th percentile adult female test dummies is identical. The data collection will involve only computer tabulation (using the same reporting format) and manufacturers will provide the information to NHTSA in an electronic (as opposed to paper) format. The data will cover the same types of vehicles for both upgrades of the belted barrier test. There are 0 hours of recordkeeping burdens resulting from the collection of information. There are no capital or start-up costs as a result of this collection. Manufacturers could collect and tabulate the information by using existing equipment. Thus, there would be no additional costs to respondents or recordkeepers. Because the scope of this collection of information differs from that described in the August 31, 2006 final rule, NHTSA invites comment on its estimates of the total annual hour and cost burdens resulting from this collection of information. Please submit any comments to the NHTSA Docket Number referenced in the heading of this notice or to: Ms. Lori Summers, Office of Rulemaking, NHTSA, 1200 New Jersey Avenue, SE., Washington, DC 20590. Ms. Summers' telephone number is:

(202)366-1740. Comments are due within 60 days of the date of publication of this document in the **Federal Register** . H. Executive Order 13045 Executive Order 13045 3 applies to any rule that:

(1)Is determined to be “economically significant” as defined under E.O. 12866, and

(2)concerns an environmental, health or safety risk that NHTSA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, we must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by us. This rule is not economically significant, and it will not have a disproportionate effect on children. 3 62 FR 19885, April 23, 1997. I. National Technology Transfer and Advancement Act Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Today's amendments do not use technical standards but merely adjust the phase-in requirements adopted in the August 2006 final rule. J. Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477 at 19478). List of Subjects in 49 CFR Parts 571 and 585 Imports, Motor vehicle safety, Reporting and recordkeeping requirements, Tires. In consideration of the foregoing, NHTSA is amending 49 CFR parts 571 and 585 as follows: PART 571—FEDERAL MOTOR VEHICLE SAFETY STANDARDS 1. The authority citation for part 571 of Title 49 continues to read as follows: Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.50. 2. Section 571.208 is amended by revising S14.6(d) and S14.6.2 to read as follows: § 571.208 Standard No. 208; Occupant crash protection. S14.6 * * *

(d)Vehicles that are manufactured by an original vehicle manufacturer that produces or assembles fewer than 5,000 vehicles annually for sale in the United States are not subject to the requirements of S14.6. S14.6.2 *Calculation of complying vehicles.*

(a)For the purposes of complying with S14.6.1.1, a manufacturer may count a vehicle if it is manufactured on or after September 1, 2008, but before September 1, 2010.

(b)For purposes of complying with S14.6.1.2, a manufacturer may count a vehicle if it:

(1)Is manufactured on or after September 1, 2008, but before September 1, 2011, and

(2)Is not counted toward compliance with S14.6.1.1.

(c)For purposes of complying with S14.6.1.3, a manufacturer may count a vehicle if it:

(1)Is manufactured on or after September 1, 2008, but before September 1, 2012, and

(2)Is not counted toward compliance with S14.6.1.1 or S14.6.1.2. 3. Section 571.301 is amended by revising S6.2(c) to read as follows: § 571.301 Standard No. 301; Fuel system integrity. S6.2 * * *

(c)*Small volume manufacturers* . Notwithstanding S6.2(b) of this standard, vehicles manufactured on or after September 1, 2004 and before September 1, 2008 by a manufacturer that produces fewer than 5,000 vehicles annually for sale in the United States may meet the requirements of S6.2(a). Vehicles manufactured on or after September 1, 2008 by small volume manufacturers must meet the requirements of S6.2(b). PART 585—PHASE-IN REPORTING REQUIREMENTS 4. The authority citation for part 585 of Title 49 continues to read as follows: Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.50. 5. Section 585.15 is amended by adding (a)(3) and (c)(3) to read as follows: § 585.15 Reporting requirements.

(a)* * *

(3)Within 60 days after the end of the production year ending August 31, 2009, each manufacturer choosing to certify vehicles manufactured during that production year as complying with phase three of the advanced air bag requirements of Standard No. 208 shall submit a report to the National Highway Traffic Safety Administration providing the information specified in paragraph

(c)of this section and in § 585.2 of this part.

(c)* * *

(3)With respect to the report identified in section 585.15(a)(3), each manufacturer shall report the number of vehicles, by make and model year, that meet the applicable advanced air bag requirements of Standard No. 208, and to which the advanced air bag requirements the vehicles are certified. 6. Section 585.16 is revised to read as follows: § 585.16 Records. Each manufacturer shall maintain records of the Vehicle Identification Number of each vehicle for which information is reported under § 585.15(c) until December 31, 2011. Each manufacturer shall maintain records of the Vehicle Identification Number of each vehicle for which information is reported under § 585.15(d)(2) until December 31, 2013. 7. Section 585.23 is revised to read as follows: § 585.23 Applicability. This subpart applies to manufacturers of passenger cars and trucks, buses, and multipurpose passenger vehicles with a GVWR of 4,536 kg or less. However, this subpart does not apply to any manufacturers whose production consists exclusively of walk-in vans, vehicles designed to be sold exclusively to the U.S. Postal Service, vehicles manufactured in two or more stages, and vehicles that are altered after previously having been certified in accordance with part 567 of this chapter. In addition, this subpart does not apply to manufacturers that produce fewer than 5,000 vehicles annually for sale in the United States. 8. Section 585.43 is revised to read as follows: § 585.43 Applicability. This subpart applies to manufacturers of passenger cars, multipurpose passenger vehicles, trucks and buses with a GVWR of 4,536 or less. However, this subpart does not apply to manufacturers that produce fewer than 5,000 vehicles annually for sale in the United States. Issued: October 29, 2007. Nicole R. Nason, Administrator. [FR Doc. E7-21600 Filed 11-1-07; 8:45 am] BILLING CODE 4910-59-P 72 212 Friday, November 2, 2007 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29317; Directorate Identifier 2007-CE-079-AD] RIN 2120-AA64 Airworthiness Directives; Cessna Aircraft Company Model 172 and 182 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive

(AD)for certain Cessna Aircraft Company Model 172 and 182 series airplanes that are equipped with the BRS-172 and BRS-182 Parachute System. This proposed AD would require the replacement of the pick-up collar support and nylon screws for the BRS-172 and BRS-182 Parachute System. This proposed AD results from notification by Ballistic Recovery Systems, Inc.

(BRS)that the pick-up collar assembly may prematurely move off the launch tube and adversely affect rocket trajectory during deployment. We are proposing this AD to prevent premature separation of the collar. This condition could result in the parachute failing to successfully deploy. DATES: We must receive comments on this proposed AD by December 3, 2007. ADDRESSES: Use one of the following addresses to comment on this proposed AD: • *Federal eRulemaking Portal: Go to http://www.regulations.gov.* Follow the instructions for submitting comments. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Fax:*

(202)493-2251. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this proposed AD, contact Ballistic Recovery Systems, Inc., 300 Airport Road, South Saint Paul, MN 55075-3551; telephone:

(651)457-7491; fax:

(651)457-8651. FOR FURTHER INFORMATION CONTACT: Gregory Michalik, Senior Aerospace Engineer, FAA, 2300 East Devon Avenue, Des Plaines, Illinois, 60018; telephone:

(847)294-7135; fax:

(847)294-7834; e-mail: *gregory.michalik@faa.gov.* SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number, “FAA-2007-29317; Directorate Identifier 2007-CE-079-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive concerning this proposed AD. Discussion We have been notified by Ballistic Recovery Systems, Inc. of a concern similar to that which prompted AD 2007-14-03, dated August 16, 2007, on the Cirrus Airplane Parachute System (CAPS), where the parachute failed to successfully deploy. Testing indicates that the force of the rocket ignition and rocket blast may prematurely break the nylon pick up collar/support screws. When functioning properly the screws should not break until impacted by a flange at the rocket base. A prematurely separated collar/support may bind on the rocket as it slides down toward the flange at the base of the rocket. This may alter the direction of the rocket. This condition, if not corrected, could result in the parachute failing to successfully deploy upon activation. Relevant Service Information We have reviewed Ballistic Recovery Systems, Inc. Service Bulletins SB 07-01, dated June 8, 2007; and SB 07-02, dated June 8, 2007. The service information describes procedures for the replacement of the pick-up collar support and screws. FAA's Determination and Requirements of the Proposed AD We are proposing this AD because we evaluated all information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design. This proposed AD would require the replacement of the pick-up collar support and screws for the BRS-172 and BRS-182 Parachute System. The BRS-172 and BRS-182 Parachute System could also be installed on Cessna 150 series airplanes and Symphony Aircraft Industries Models OMF-100-160 and SA 160 airplanes. The corrective actions proposed in this NPRM are specific to the Cessna 172 and 182 series airplanes. We are evaluating these other BRS installations and, based on this evaluation, may consider additional rulemaking on this subject. Costs of Compliance We estimate that this proposed AD would affect 54 airplanes in the U.S. registry. We estimate the following costs to do the proposed modification: Labor cost Parts cost Total cost per airplane Total cost on U.S. operators 1 work-hour × $80 per hour = $80 N/A $80 $4,320 Note: BRS will provide warranty credit to the extent noted in Ballistic Recovery Systems, Inc. Service Bulletins SB 07-01 and SB 07-02, both dated June 8, 2007. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. Examining the AD Docket You may examine the AD docket that contains the proposed AD, the regulatory evaluation, any comments received, and other information on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone

(800)647-5527) is located at the street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Cessna Aircraft Company:** Docket No. FAA-2007-29317; Directorate Identifier 2007-CE-079-AD. Comments Due Date

(a)We must receive comments on this airworthiness directive

(AD)action by December 3, 2007. Affected ADs

(b)None. Applicability

(c)This AD applies to the following airplane models, all serial numbers, certificated in any category, that are equipped with:

(1)BRS-172 Parachute System installed via Supplemental Type Certificate

(STC)SA01679CH, or

(2)BRS-182 Parachute System installed via STC SA01999CH. Cessna 172 models Cessna 182 models 172 182 172A 182A 172B 182B 172C 182C 172D 182D 172E 182E 172F (USAF T-41A) 182F 172G 182G 172H (USAF T-41A) 182H 172I 182J 172K 182K 172L 182L 172M 182M 172N 182N 172P 182P 172Q 182Q 172R 182R 172S 182S 182T R182 T182 TR182 T182T Unsafe Condition

(d)This AD results from notification by Ballistic Recovery Systems, Inc.

(BRS)that the pick-up collar assembly may prematurely move off the launch tube and adversely affect rocket trajectory during deployment. We are issuing this AD to prevent premature separation of the collar. This condition could result in the parachute failing to successfully deploy. Compliance

(e)To address this problem, you must do the following, unless already done: Actions Compliance Procedures Remove and replace the pick-up collar support and two retaining screws Within the next 25 hours time-in-service after the effective date of this AD

(i)For Cessna Model 172 airplanes follow BRS SB 07-01, dated June 8, 2007.

(ii)For Cessna Model 182 airplanes, follow BRS SB 07-02, dated June 8, 2007. Alternative Methods of Compliance (AMOCs)

(f)The Manager, Chicago Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Gregory Michalik, Senior Aerospace Engineer, FAA, 2300 East Devon Avenue, Des Plaines, Illinois 60018; telephone:

(847)294-7135; fax:

(847)294-7834; e-mail: *gregory.michalik@faa.gov.* Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector

(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Related Information

(g)To get copies of the service information referenced in this AD, contact Ballistic Recovery Systems, Inc., 300 Airport Road, South Saint Paul, MN 55075-3551; telephone:

(651)457-7491; fax:

(651)457-8651. To view the AD docket, go to U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, or on the Internet at *http://www.regulations.gov.* The docket number is Docket No. FAA-2007-29317; Directorate Identifier 2007-CE-079-AD. Issued in Kansas City, Missouri, on October 26, 2007. Kim Smith, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-21571 Filed 11-1-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF LABOR Employment and Training Administration 20 CFR Part 616 RIN 1205-AB51 Federal-State Unemployment Compensation Program (UC); Interstate Arrangement for Combining Employment and Wages AGENCY: Employment and Training Administration, Labor. ACTION: Notice of Proposed Rulemaking (NPRM); request for comments. SUMMARY: The U.S. Department of Labor (Department) is proposing to amend its regulations governing combined-wage claims

(CWC)filed under the Federal-State UC program. Most significantly, the Department proposes to amend the definition of “paying State.” The Department also invites comments on all issues relating to the CWC arrangement and its governing regulations. DATES: To be ensured consideration, comments must be submitted in writing on or before January 2, 2008. ADDRESSES: You may submit comments, identified by Regulatory Information Number

(RIN)1205-AB51, by any of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Mail: Submit comments to Thomas Dowd, Administrator, Office of Policy Development and Research, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue, NW., Room N-5641, Washington, DC 20210. Because of security-related concerns, there may be a significant delay in the receipt of submissions by United States Mail. You must take this into consideration when preparing to meet the deadline for submitting comments. • Hand Delivery/Courier: 200 Constitution Avenue, NW., Room N-5641. The Department will post all comments received on *www.regulations.gov* without making any change to the comments, including any personal information provided. The *www.regulations.gov* Web site is the Federal e-rulemaking portal and all comments posted there are available and accessible to the public. The Department recommends that commenters not include their personal information such as Social Security Numbers, personal addresses, telephone numbers, and e-mail addresses in their comments as such submitted information will become easily available to the public via the *www.regulations.gov* Web site. Comments submitted through *www.regulations.gov* will not include the e-mail address of the commenter unless the commenter chooses to include that information as part of their comment. It is the responsibility of the commenter to safeguard his or her information. *Instructions:* All submissions received must include the agency name and the RIN for this rulemaking: RIN 1205-AB51. If commenters transmit comments through the Internet and also submit a hard copy by mail, please indicate that it is a duplicate copy of the Internet transmission. *Docket:* All comments will be available for public inspection and copying during normal business hours by contacting the Office of Policy Development and Research at

(202)693-3700. As noted above, the Department also will post all comments it receives on *www.regulations.gov.* This Federal eRulemaking portal is easily accessible to the public. The Department cautions the public to avoid providing personal information in your comments that you do not want to become public via the Internet, such as social security number, personal address, phone number, and e-mail address. Copies of the proposed rule are available in alternative formats of large print and electronic file on computer disk, which may be obtained at the above-stated address. The proposed rule is available on the Internet at the Web address *http://www.doleta.gov.* FOR FURTHER INFORMATION CONTACT: Jacqui Shoholm, Director of the Division of Policy, Legislation and Regulations, Office of Policy Development and Research, Employment and Training Administration,

(202)693-3700 (this is not a toll-free number) or 1-877-889-5627 (TTY), or *Shoholm.jacqui@dol.gov.* SUPPLEMENTARY INFORMATION: I. Background General Section 3304(a)(9)(B) of the Federal Unemployment Tax Act

(FUTA)(26 U.S.C. 3304(a)(9)(b)) requires each State, as a condition of participation in the Federal-State UC program, to participate in any arrangement specified by the Secretary of Labor for payment of UC on the basis of combining an individual's employment and wages in two or more States. A claim filed under this arrangement is a Combined Wage Claim or “CWC.” Section 3304(a)(9)(B), FUTA, is implemented at 20 CFR part 616. As explained in § 616.1, the purpose of the arrangement is to permit an unemployed worker with covered employment or wages in more than one State to combine all such employment and wages in one State, in order to qualify for benefits or to receive more benefits. Section 616.2 explains that, in accordance with section 3304(a)(9)(B), the arrangement was developed in consultation with the representative of the State UC agencies, currently known as the National Association of State Workforce Agencies (“NASWA”). The arrangement provides at § 616.7(a) that any unemployed individual who had employment covered under the UC law of two or more States, whether or not he or she has earned sufficient wages to qualify for UC under one or more of them, may elect to file a CWC. Under § 616.6(e)(1), the “paying State” is the State in which the claimant files the CWC, if he or she qualifies for benefits under the UC law of that State on the basis of combined employment and wages. Section 616.6(e)(2) identifies the “paying State” when either the CWC claimant does not qualify for unemployment benefits under the UC law of the State in which he or she files the CWC or the claimant files a CWC in Canada. Under § 616.8, the “paying State” assumes the responsibility for arranging the transfer of wages from other State(s) where wages were earned (that is, the “transferring State,” as defined at § 616.6(f)) during the “paying State's” base period (that is, the period during which wages earned are counted toward determining benefit eligibility and amount). In addition to making benefit payments to eligible individuals, the “paying State” also issues all determinations relating to eligibility for benefits based on its UC law. Section 616.9 explains the responsibilities of the transferring State to transfer the covered employment and wages of the CWC claimant to the “paying State” and reimburse the “paying State” for benefits based upon wages earned in the transferring State. For the reasons explained below, the Department proposes to amend the definition of “paying State” in § 616.6(e) of 20 CFR, add a new paragraph

(f)to § 616.7 requiring that where a State denies a CWC it must notify the claimant of the option of filing in another State, and make a conforming amendment to § 616.8(a) addressing the responsibilities of the “paying State.” The Department also proposes to delete as unnecessary § 616.5, which makes December 31, 1971, the effective date of the arrangement. Reasons for Regulatory Change The current regulation for determining the “paying State” for CWCs was issued in 1974 (39 FR 45215, December 31, 1974) to replace a more complicated test for determining the “paying State.” It was intended to speed payments to eligible claimants by streamlining a manual process which relied on mailing paper forms between States to determine which State would be the “paying State.” That system could take weeks or months to determine which State should be the “paying State” for a particular claim. The simple solution, adopted in 1974 (§ 616.6(e)(1)), makes the “paying State” the State in which the claimant filed the claim. This amendment made the “paying State” readily identifiable, and, because UC claims were filed in person in 1974, this amendment also was convenient for the claimant, who would be physically present in the State in which he or she filed the claim. Under § 616.9, all of the claimant's wages are to be transferred to this “paying State,” whose law governs the CWC under § 616.8. If the claimant does not qualify for benefits in the State in which he or she filed the claim, § 616.6(e)(2) applies. The Department now proposes to amend the definition of “paying State.” Information-sharing technology now exists among States which allows for more immediate determinations of where wages have been earned. Therefore, it is no longer necessary to make the “paying State” the State in which the claimant chooses to file the CWC, as the current regulations do. Permitting the claimant to choose the “paying State” led to an unintended consequence, forum shopping. Under the current definition, the “paying State” need not be a State in which the individual has covered wages. Rather, that definition makes the “paying State” any State in which the claimant files a CWC if the claimant qualifies for benefits in that State on the basis of combining his or her wages under that State's law. As a result, an individual may claim in a State with a higher weekly benefit amount

(WBA)than exists in any of the States in which the claimant had covered employment. Forum shopping occurs because WBAs vary greatly among States. (For example, the maximum WBA in Mississippi is $210 compared with $575 (plus allowances for dependents) in Massachusetts.) The Department believes that forum shopping is undesirable for several reasons. First, it may unfairly advantage claimants who worked in multiple States over those who worked in just one State by affording CWC claimants the choice of filing a UC claim in a State with a higher WBA. Second, “forum shopping” results in higher costs for the claimant's employers, because the claimant files a CWC in a State paying higher benefits, which are ultimately funded by those employers. Moreover, forum shopping undermines the insurance principles of the Federal-State UC program. Under an insurance program, benefits are payable based on a specific plan. In the case of UC, benefits are payable under a State's plan for compensating unemployment. This plan balances premiums (in the form of employer contributions) with benefit outlays (in the form of payments to individuals), requiring that benefit rights and contribution rates be coordinated. CWCs are unique in that insured wages are necessarily combined under a single State's plan. However, the current § 616.6(e)(1) permits a CWC claimant to elect benefits under the UC law of a State in which he or she had no employment. This approach allows the claimant to choose a plan with the most favorable coverage even though the claimant otherwise has no coverage under that plan. Although the CWC arrangement cannot be amended to provide for the payment of benefits in accordance with the laws of two or more States, the proposed amendment to § 616.6(e) would require that the benefits be determined under the law of one State in which the claimant had insured base period wages. This result conforms more closely to the insurance principles of the program. The proposed amendment to § 616.6(e) would to some extent limit benefit eligibility, because it would limit the determination of entitlement to a State in which the claimant had base period wages. Thus, under the proposed section, an individual who had base period wages in two or more States, but who is unable to qualify for benefits in any of these States, would be denied benefits. To the contrary, the current § 616.6(e) permits a claimant's entitlement to also be determined under a State law where he or she had no wages. Thus, under the current section, that claimant might be able to find another State under whose law he or she would qualify and file the CWC there. However, this scenario is likely to have been rare and the Department believes that this result is reasonable. It is consistent with the insurance principles that benefit rights be determined under the State law under which the claimant had employment and wages in the State's base period. The Department considered a number of options for preventing forum shopping. The proposed rule provides the most practical and least complicated set of tests for determining the “paying State” and is also the least restrictive in allowing the claimant some choice in selecting that State. The Department considered using a “majority of wages” test; however, that test would require the State against which the claim was originally filed to obtain the wages from all States where the claimant earned wages and then determine where the majority of base period wages were located. Although information-sharing technology now exists among States allowing for more immediate determinations of where wages were earned, wages are not immediately or automatically entered into a State's wage data base; State practices vary widely in how wages are captured and entered into the State system. Therefore, many such preliminary determinations could be erroneous, requiring that the CWC be cancelled in one State and filed again in another State with a resulting overpayment in the first State. Also, alternative base periods are a complicating factor. It is possible the claimant would have the “majority” of wages under State A's regular base period, but also have the “majority” of wages under State B's alternative base period. Thus, the State against which the CWC was filed would need to complete a complex and cumbersome process to determine which State had the majority of wages. Should the “majority” State not be the State against which the claim was filed, the State against which the claim was filed would need to deny the claim and advise the claimant where to file. This process would create delays and confusion, and would be much more complex than allowing the claimant to file in any State where he or she earned wages. Those States would, contrary to the “majority” State, be readily identifiable. The Department also considered redefining “paying State” as the State in which the individual was last employed. The Department values consistency in the treatment of claimants and believes that, to the extent possible, CWC claimants should be treated the same as non-CWC claimants. For a claimant with base period wages and employment in only one State, the determination of entitlement will be based solely on his/her wages and employment during the base period. Similarly, the Department believes that, when a claimant has base period wages and employment in more than one State, the determination of entitlement should be based solely on his/her base period wages and employment in those States, rather than whether the claimant has wages with a non-base period employer in another State. Additionally, there is difficulty in ensuring the accurate and timely identification of the most recent employer for UI purposes. Claimants do not always know the correct name of their last employer. Also, in some cases, wages are not required to be reported by employers until months after a claimant has been separated from employment. These more recent wages will not be available at the time of filing and would need to be requested by the State, which would be administratively cumbersome and possibly delay the initial payment of UC. Accordingly, the proposed definition of “paying State” as any State in which the claimant earned base period wages would make that State readily identifiable without the need for complex procedures and determinations. It would not totally eliminate claimant choice, but still serve the purpose of preventing forum shopping. For these reasons, the Department proposes to update the CWC regulations as follows to prevent forum shopping and conform them to the UC program's insurance principles. II. Summary of the Proposed Rule The proposed rule would amend the definition of “paying State” at § 616.6(e) to provide that the “paying State” is a “single State against which the claimant files a Combined-Wage Claim,” if—

(1)The claimant has wages and employment in the State's base period(s) (that is, the time period(s) during which the claimant's wages count toward eligibility for, and the amount of, UC); and

(2)the claimant qualifies for UC under the law of that State using combined wages and employment. Under the proposed § 616.6(e), if a claimant had wages and employment in the base period(s) of State A and the base period(s) of State B, the claimant may elect either State A or State B, because the “paying State” must be a “single” State. Further, no State other than State A or State B could serve as the “paying State,” because the claimant had wages in the base period(s) of no other State. Under § 616.6(i) of 20 CFR, “base period” is defined as the base period “applicable under the unemployment compensation law of the paying State.” Thus, the proposed rule would apply the elected “paying State's” definition of “base period.” If an individual had insufficient wages and employment to qualify under the elected “paying State's” regular base period, then that State's rules of monetary entitlement (including any provisions regarding alternative base periods) would govern. (Some States use an “alternative base period” in addition to the regular base period to afford a claimant with wages outside the regular base period an opportunity to qualify for benefits.) Thus, a claimant, who could not qualify under the regular base period, would be able to seek benefits under the elected “paying State's” alternative base period, if one existed. The proposed definition at § 616.6(e) would replace the current § 616.6(e)(1) and § 616.6(e)(2). The current § 616.6(e)(2) addresses what happens if the claimant fails to qualify under the law of the State in which he or she filed a CWC, by providing that in that event the “paying State” is the “State where the Combined-Wage Claimant was last employed in covered employment among the States in which the claimant qualifies for unemployment benefits on the basis of combined employment and wages * * *.” The Department proposes removing this provision because it would no longer be necessary. The proposed definition of “paying State” would permit a claimant whose CWC was denied to file another CWC in a second State where he or she had base period wages. At the time of claim filing, or shortly thereafter, the claimant's base period wage and earnings history is reviewed for accuracy with the claimant. Because current technology now permits State agency staff to view claimant wages and eligibility criteria for other States, where they find such wages, they are able to provide prompt notice to the claimant of all claim filing options. If that second State denied the CWC, the claimant could file in a third State where he or she had wages, and so on. Thus, where a claimant failed to qualify under the law of the State in which he or she filed the CWC, the claimant could file again in another State where he or she had wages. The proposed rule would add a new paragraph

(f)to § 616.7 requiring the denying State to inform the claimant of this option to file again elsewhere. It should also be noted that the current § 616.6(e)(2) provides that if a CWC is filed in Canada, then the “paying State” is the “State where the Combined-Wage Claimant was last employed in covered employment among the States in which the claimant qualifies for unemployment benefits on the basis of combined employment and wages * * *.” The preamble of the 1974 rule (39 FR 45215-16) explained that it referenced Canada to acknowledge that while Canada could not be a “paying State,” claims may be filed in Canada against a State of the United States under the Interstate Benefit Payment Plan (IBPP). That Plan provides for a State, or Canada, helping a claimant file a UC claim against another State. In eliminating the current § 616.6(e)(2), the proposed rule would eliminate the reference to Canada. However, that reference is unnecessary since, as the 1974 rule noted, Canada cannot be a “paying State.” Further, the CWC regulations do not implement the IBPP and the current regulations do not, in any event, explicitly indicate that Canada is a party to it. In removing that reference, the Department does not intend to signal that Canada is not a party to the IBPP. The proposal also includes a conforming amendment to § 616.8(a), which sets forth the responsibilities of the “paying State” regarding the transfer of employment and wages and the payment of benefits. One requirement in this section is that the “paying State” must, with an exception not relevant to the Department's proposed amendment, apply its own law to CWC determinations, even if the claimant had no covered wages in the “paying State.” The Department's proposed amendment to the definition of “paying State” ensures that there always will be covered wages in a “paying State.” Therefore, since the reference to a claimant having no covered wages in the “paying State” would no longer be relevant and would contradict the Department's purpose in amending the regulations, the Department proposes to eliminate it. Lastly, the Department proposes to delete the effective date provision of the CWC arrangement because it is no longer needed. Request for Comments The Department sets forth in this NPRM a proposal to modernize the CWC system by amending the definition of “paying State” and amending other regulatory provisions to take into account the amended definition. The Department is interested in receiving comments on its proposed amendments to Part 616, as well as alternative proposals for preventing forum shopping. Additionally, since the CWC arrangement has been in existence for over thirty-five years without change to its basic structure, the Department requests comments on the desirability of amending any of its provisions at Part 616. III. Administrative Provisions Executive Order 12866 This proposed rule is not economically significant. Under Executive Order 12866, a rule is economically significant if it materially alters the budgetary impact of entitlements, grants, user fees, or loan programs; has an annual effect on the economy of $100 million or more; or adversely affects the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way. The Department has determined that this proposed rule is not economically significant under the Executive Order because it will not have an economic impact of $100 million or more on the State agencies or the economy. Paperwork Reduction Act Under the Paperwork Reduction Act (PRA), the Department of Labor is required to submit any information collection requirements to the Office of Management and Budget

(OMB)for review and approval. 44 U.S.C. 3501 *et seq.* This proposed rule does not impose any new requirements or modification of the existing requirements on the States that have not already been approved by OMB for collection. Therefore, the Department has determined that this proposed rule does not contain a new information collection requiring it to submit a paperwork package to OMB. Executive Order 13132: Federalism Executive Order 13132 at section 6 requires federal agencies to consult with State entities when a regulation or policy may have a substantial direct effect on the States or the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government, within the meaning of the Executive Order. Section 3(b) of the Executive Order further provides that federal agencies must implement regulations that have a substantial direct effect only if statutory authority permits the regulation and it is of national significance. Further, section 3304(a)(9)(B), FUTA, requires consultation with the State agencies in developing the CWC arrangement. Section 616.2 of the CWC regulations also provides that for purposes of “such consultation in its formulation and any future amendment the Secretary recognizes, as agents of the State agencies, the duly designated representatives of the NASWA.” Consultation has occurred on an informal basis with the States through NASWA. The Department intends to consult with the UI Committee or any other representative(s) of the States selected by the NASWA, during the 60-day comment period for this proposed rule. Unfunded Mandates Reform Act of 1995 This regulatory action has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Under the Act, a federal agency must determine whether a regulation proposes a federal mandate that would result in the increased expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. The Department has determined that this proposed rule does not create any unfunded mandates because it will not significantly increase aggregate costs of the CWC arrangement. The effect of this proposal is to preclude forum shopping and tie UC eligibility more closely to the insurance principle of the Federal-State UC program, and it does not create additional entitlements. This proposed modification does not add an additional burden on States with respect to claim processing because it does not alter the States' delivery of claim filing services. Effect on Family Life The Department certifies that this proposed rule has been assessed according to section 654 of Pub. L. 105-277 for its effect on family well-being. This provision protects the stability of family life, including marital relationships, financial status of families, and parental rights. The Department concludes that this proposed rule will not adversely affect the well-being of the nation's families. This proposed rule's change in the definition of “paying State” will more closely tie CWC eligibility to the insurance principle underlying the Federal-State UC program without affecting an individual's ability to file a CWC. The Department also intends that the proposed rule will eliminate the practice of forum shopping that has occurred under the current CWC arrangement. The proposed change maintains consistency and equity in the treatment of claimants across all program areas. Therefore, the Department certifies that this proposed rule does not adversely impact family well-being. Regulatory Flexibility Act / SBREFA We have notified the Chief Counsel for Advocacy, Small Business Administration, and made the certification according to the Regulatory Flexibility Act

(RFA)at 5 U.S.C. 605(b), that this proposed rule will not have a significant economic impact on a substantial number of small entities. Under the RFA, no regulatory flexibility analysis is required where the rule “will not * * * have a significant economic impact on a substantial number of small entities.” 5 U.S.C. 605(b). A small entity is defined as a small business, small not-for-profit organization, or small governmental jurisdiction. 5 U.S.C. 601(3)-(5). Therefore, the definition of the term “small entity” does not include States. This proposed rule describes procedures governing State administration of the CWC arrangement under the federal-State UC program, which does not extend to small governmental jurisdictions. Therefore, the Department certifies that this proposed rule will not have a significant impact on a substantial number of small entities and, as a result, no regulatory flexibility analysis is required. In addition, the Department certifies that this proposed rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996 (SBREFA). Under section 804 of SBREFA, a major rule is one that is an “economically significant regulatory action” within the meaning of Executive Order 12866. Because this proposed rule is not an economically significant rule under Executive Order 12866, the Department certifies that it also is not a major rule under SBREFA. List of Subjects in 20 CFR Part 616 Labor, and Unemployment compensation. Words of Issuance For the reasons stated in the preamble, the Department proposes to amend 20 CFR part 616 as set forth below: PART 616—INTERSTATE ARRANGEMENT FOR COMBINING EMPLOYMENT AND WAGES 1. The authority citation for 20 CFR part 616 is revised to read as follows: Authority: 26 U.S.C. 3304(a)(9)(B); Secretary's Order No. 3-2007, April 3, 2007 (72 FR 15907). § 616.5 [Removed] 2. Remove § 616.5. 3. Revise paragraph

(e)of § 616.6 to read as follows: § 616.6 Definitions.

(e)*Paying State.* A single State against which the claimant files a Combined-Wage Claim, if the claimant has wages and employment in that State's base period(s) and the claimant qualifies for unemployment benefits under the unemployment compensation law of that State using combined wages and employment. 4. Add paragraph

(f)to § 616.7 to read as follows: § 617.7 Election to file a Combined-Wage Claim.

(f)If a State denies a Combined-Wage Claim, it must inform the claimant of the option to file in another State in which the State finds that claimant has wages and employment during that State's base period(s). § 616.8 [Amended] 5. In § 616.8(a) remove the words “, even if the Combined-Wage Claimant has no earnings in covered employment in that State”. Signed at Washington, DC, this 29th day of October 2007. Emily Stover DeRocco, Assistant Secretary for Employment and Training. [FR Doc. E7-21513 Filed 11-1-07; 8:45 am] BILLING CODE 4510-FW-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 RIN 0910-ZA30 [Docket No. 2006N-0168] Food Labeling: Revision of Reference Values and Mandatory Nutrients AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: The Food and Drug Administration

(FDA)is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on what new reference values the agency should use to calculate the percent daily value

(DV)in the Nutrition Facts and Supplement Facts labels and what factors the agency should consider in establishing such new reference values. In addition, FDA requests comments on whether it should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels. Comments on what factors should be considered to update the agency's reference values will inform any FDA rulemaking that may result from this ANPRM. DATES: Submit written or electronic comments by January 31, 2008. ADDRESSES: You may submit comments, identified by Docket No. 2006N-0168, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and Docket No. and Regulatory Information Number

(RIN)for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2579, or e-mail: *Paula.Trumbo@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Development of Current DVs B. Nutrient Content Final Rule C. Labeling of Dietary Supplements D. IOM DRIs and Acceptable Macronutrient Distribution Ranges E. IOM Report on Guiding Principles for Nutrition Labeling F. IOM Report on the Definition of Fiber G. Current Regulations on *Trans* Fat H. ANPRM on Prominence of Calories I. Carbohydrate Content of Food J. “2005 Dietary Guidelines for Americans” II. Agency Request for Information A. Approach for Setting DVs B. Populations for Which the DVs are Intended C. Labeling of Individual Nutrients D. Other Questions E. Process Questions F. Questions on Consumer and Producer Use and Understanding of DVs III. Comments IV. References Appendix A Acronyms Used in This Document Appendix B Examples of Nutrition Facts and Supplement Facts Labels I. Background 1 1 A list of the acronyms cited in this ANPRM are defined in Appendix A. On November 8, 1990, the Nutrition Labeling and Education Act

(NLEA)of 1990 (Public Law No. 101-535) was signed into law (the 1990 amendments) amending the Federal Food, Drug, and Cosmetic Act (the act). The 1990 amendments made the most significant changes in the act and had a direct bearing on FDA's revision of nutrition labeling in 1993. The 1990 amendments added section 403(q) (21 U.S.C. 403(q)) to the act which specified, in part, that:

(1)With certain exceptions, a food is to be considered misbranded unless its label or labeling bears nutrition labeling;

(2)certain nutrients and food components are to be included in nutrition labeling, although the Secretary of Health and Human Services can add or delete nutrients by regulation if it is found necessary to assist consumers in maintaining healthy dietary practices;

(3)nutrition labeling is to be provided for the most frequently consumed varieties of raw produce (fruits and vegetables) and raw fish according to voluntary guidelines or, if necessary, regulations;

(4)a simplified nutrition label is to be used when the food contains insignificant amounts of most nutrients; and

(5)FDA is to develop regulations governing labeling of foods to which section 411 of the act (21 U.S.C. 350) applies (i.e., vitamin and minerals). In response to the NLEA, FDA, in 1993, issued several rules to modify how nutrition information is presented on food labels. When the agency issued those rules to modify the nutrition label information, it considered the diet and health information that was current at that time, including the National Academy of Sciences

(NAS)Recommended Dietary Allowances

(RDAs)(Refs. 1 to 3), the NAS Diet and Health Report (Ref. 4), the Surgeon General's Report on Nutrition and Health (Ref. 5), and the 1990 Dietary Guidelines for Americans (Ref. 6). New information has since become available on nutrient values that the agency believes may impact what nutrients it should consider requiring to be listed on the food label and what nutrient values it should use as a basis for the DVs on the food label. The new information includes revisions to the Dietary Guidelines for Americans (Ref. 7), the Institute of Medicine's (IOM's) published reports on the Dietary Reference Intakes

(DRIs)that update recommendations for the intake of vitamins, minerals, and macronutrients (Refs. 8 to 14), the IOM report on the application of the DRIs (Ref. 15), and the IOM report on “Guiding Principles for Nutrition Labeling and Fortification” that provides recommendations on the use of the new DRIs in nutrition labeling (Ref. 16). The latter reports stimulated extensive discussion in the scientific community (e.g. at nutrition and food science conferences and in publications (Refs. 17 to 19); FDA and the IOM recognize that the approach to setting a DV in the labeling report (Ref. 16) represents a new approach that requires evaluation. At the IOM's 2007 workshop on “The Development of DRI's 1994-2004: Lessons Learned and New Challenges,” there was discussion about the limitations of the framework that was used to set the DRIs, as well as recommendations for future consideration. For all of these reasons, FDA finds it important to seek comment on the recommendations made in these reports (Refs. 7 to 16). In addition, the agency is considering changes to the food label in more recently published ANPRMs concerning prominence of calories and the labeling of *trans* fats. The agency discusses, below, the 1993 rules on food labeling, these ANPRMs, and publications and reports available since 1993, to provide background for the questions the agency is asking in this ANPRM related to a future proposed rule to update the presentation of nutrients and content of nutrient values on food labels. A. Development of Current DVs In the final rule on Food Labeling; Reference Daily Intakes and Daily Reference Values (the 1993 RDI/DRV final rule) (58 FR 2206, January 6, 1993), FDA amended its regulations to establish two sets of label reference values: Reference Daily Intakes

(RDIs)and Daily Reference Values

(DRVs)for use in declaring the nutrient content of a food on its label or labeling. These two reference values were used to establish a single set of label reference values known as the DVs, which were intended to assist consumers in both understanding the relative significance of nutritional information in the context of a total daily diet and in comparing the nutritional values of food products. 1. RDIs In the **Federal Register** of July 19, 1990 (55 FR 29476), FDA proposed to replace the U.S. Recommended Daily Allowances (U.S. RDAs) as the reference values for certain vitamins and minerals used in nutrition labeling of foods with updated and expanded reference values (the 1990 proposal). The U.S. RDAs set in 1973 were based primarily on the NAS 1968 RDA values for vitamins and minerals (Ref. 1). However, the U.S. RDAs for certain vitamins and minerals for which no RDA had been identified (biotin, pantothenic acid, copper, and zinc) were based on information cited in the NAS's “Recommended Dietary Allowances,” 7th edition (Ref. 1). The NAS RDAs were updated in 1974 and 1980, and again in 1989 along with revised values for the listing known as “Estimated Safe and Adequate Daily Dietary Intakes” (ESADDIs). 2 In 1990, FDA decided that it needed to update the U.S. RDA values, in part, due to the revisions of the 1989 NAS RDA and ESADDI values. FDA proposed to redesignate “U.S. RDAs” as “RDIs,” 3 and to establish five sets of RDIs for different developmental groups, i.e., adults and children 4 or more years of age (excluding pregnant or lactating women), children less than 4 years of age, infants, pregnant women, and lactating women. FDA also proposed using a population-weighted average of the relevant NAS RDAs and ESADDIs to establish the RDIs because it would “serve the purpose of providing an overall reference value for food labeling more appropriately than a highest value” and “because of decreasing public health concern with nutritional deficiencies, it makes less sense to use maximum values as the basis for these reference values” (55 FR 29476 at 29478). 2 The ESADDIs are nutrient values set by NAS for essential nutrients for which data are available to estimate a range of requirements, but insufficient for developing a specific RDA (Ref. 3). 3 In 1993, FDA redesignated the term U.S. RDA to RDI because the term U.S. RDA was easily confused with the term RDA (58 FR 2206 at 2207). In the 1993 RDI/DRV final rule, FDA redesignated the U.S. RDA values in part 101 (21 CFR part 101) for vitamins and minerals as RDIs. In addition, FDA established, under 21 CFR part 104, a single set of label reference values for adults and children 4 or more years of age, in part, because of space constraints on the food label and the fact that children over the age of 4 years consume the same foods that the rest of the population consumes (58 FR 2206 at 2213). These RDIs were based on the NAS RDAs set in 1968. Although FDA proposed in 1990 to base the RDIs on a population-weighted average of the RDAs and ESADDIs, in the 1993 RDI/DRV final rule FDA used the highest RDA for adults and children 4 or more years of age (excluding values for pregnant and lactating women) to serve as label reference values (58 FR 2206 at 2210 to 2213). FDA found that there was considerable and uniform support in the comments for continuing to select the highest nutrient value from this group and that vulnerable or at-risk groups would be sufficiently covered by electing the highest value. FDA referred to this approach as the “population-coverage approach.” On October 6, 1992, Congress passed the Dietary Supplement Act of 1992 that, in section 203, instructed FDA to not issue regulations before November 8, 1993, that would revise the U.S. RDAs (redesignated as RDIs) for vitamins or minerals (other than existing regulations that established the U.S. RDAs specified in § 101.9(c)(7)(iv) that were in effect prior to October 6, 1992). Thus, FDA did not codify new nutrient values in the 1993 RDI/DRV final rule. In the **Federal Register** of December 28, 1995 (60 FR 67164) (the 1995 final rule), FDA amended certain RDIs based on the 1989 NAS RDAs and ESADDIs. In the 1995 final rule, FDA amended its regulations to establish RDIs for vitamin K and selenium based on the 1989 NAS RDAs, and for manganese, chromium, molybdenum, and chloride based on the 1989 ESADDIs (Ref. 3). FDA did not establish a DV for fluoride in the 1995 final rule because the 1989 NAS RDA report stated that published studies “do not justify a classification of fluorine 4 as an essential element, according to accepted standards” (Ref. 3 at p. 235) and because the primary sources of dietary fluoride (e.g., community water supplies, toothpastes, mouth rinses) are not required to bear nutrition labeling (60 FR 67164 at 67168). FDA concluded that the declaration of percent DV of fluoride within nutrition labeling on a limited number of foods that are relatively minor sources of the nutrient would be of little use in assisting consumers in maintaining healthy dietary practices (60 FR 67164 at 67168). 4 Fluoride is the ionized form of the element fluorine. In addition, a notification was submitted under section 403(r)(2)(G) of the act (21 U.S.C. 343(r)(2)(G)) in 2001 for the use of certain nutrient content claims for choline. These statements identify the daily value for choline as 550 milligrams (mg). 5 This value is based on the Adequate Intake

(AI)set by the Institute of Medicine

(IOM)of the NAS in 1998 (Refs. 9 and 20). 5 FDA has not acted to prohibit or modify the claims, and therefore, manufacturers may use the specified claims on the label and in the labeling of any food or dietary supplement product that qualifies for the claims described in the notification. 2. DRVs The 1993 RDI/DRV final rule also identified DRVs for those nutrients that are important to diet and health (e.g., total fat, saturated fat, cholesterol, total carbohydrate (CHO), protein, dietary fiber, sodium, and potassium). The DRVs are based on the NAS Diet and Health Report (sodium, potassium, fat, saturated fat, cholesterol, carbohydrate, and dietary fiber) (Ref. 4), the Surgeon General's Report on Nutrition and Health (dietary fiber) (Ref. 5), and the 1990 Dietary Guidelines for Americans (Ref. 6). The DRV for protein (50 grams per day (g/d)) was set at 10 percent of 2,000 calories based on an adjusted average of the 1989 RDA (Ref. 3). The use of “calories” to mean “kilocalories” (kcals) is commonly accepted and more readily understood by consumers. The DRVs in the 1993 RDI/DRV final rule (58 FR 2206) were based on a 2,000 calorie reference diet. In the 1990 proposal (55 FR 29476 at 29482), FDA proposed using a 2,350 calories reference diet based on a population adjusted mean of recommended calorie allowances for persons 4 or more years of age (excluding pregnant and lactating women) (from table 3-5 of the 10th edition of “Recommended Dietary Allowances” (Ref. 3)). However, FDA received several comments opposing the 2,350 reference values because of concerns that this value was too high, especially among women (58 FR 2206 at 2217). In addition, several comments suggested that using 2,000 calories as a reference diet would be easier for consumers to use in calculations and closer to caloric requirements of older women who are “at risk for excessive calories and fat” ( *id.* ). The 2,000 calorie reference diet FDA adopted was consistent with the “population-coverage approach” as it selected a lower calorie basis for the DRVs for the group at risk (i.e., older women). B. Nutrient Content Final Rule In the **Federal Register** of January 6, 1993 (58 FR 2079), FDA published a final rule entitled “Food Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content Revision, Format for Nutrition Label” (the 1993 nutrient content final rule). The 1993 nutrient content final rule:

(1)Requires nutrition labeling on most foods that are regulated by FDA,

(2)revises the list of required nutrients and food components and the conditions for declaring them in nutrition labeling,

(3)specifies a new format for declaring nutrition information,

(4)allows specified products to be exempt from nutrition labeling, and

(5)prescribes a simplified form of nutrition labeling and the circumstances in which such simplified nutrition labeling can be used. An example of a Nutrition Facts label can be found in appendix B. 1. Required and Voluntary Labeling of Nutrients on Food Products (§ 101.9(c)) With respect to nutrition labeling of foods, the 1993 nutrient content final rule declared that nutrition information on the label and in labeling of foods shall contain information about the level of the following nutrients:

(1)Calories or total calories;

(2)calories from fat;

(3)calories from saturated fat (voluntary);

(4)total fat;

(5)saturated fat;

(6)polyunsaturated fat (voluntary);

(7)monounsaturated fat (voluntary);

(8)cholesterol;

(9)sodium;

(10)potassium (voluntary);

(11)total carbohydrate (including sugars (mono- and disaccharides), oligosaccharides, starch, fiber, and organic acids);

(12)dietary fiber;

(13)soluble fiber (voluntary);

(14)insoluble fiber (voluntary);

(15)sugars;

(16)sugar alcohol (voluntary);

(17)other carbohydrate (voluntary);

(18)protein; and

(19)vitamins and minerals (see § 101.9(c)(1) through (c)(8)). However, those nutrients that can be declared voluntarily, as described previously in this document, must be declared when a nutrient content or health claim is made (§ 101.9(c)). In the **Federal Register** of July 11, 2003 (68 FR 41434), FDA amended its regulations on nutrition labeling to require *trans* fatty acids be declared in grams per serving in the nutrition label of conventional foods and dietary supplements (see section G). Nutrient information for both mandatory and any voluntary nutrients that are to be declared in the nutrition label, except vitamins and minerals, shall be declared with the name of each nutrient, and the quantitative amount by weight for that nutrient (i.e. g or mg) (see § 101.9(d)(7)(i)). A listing of the percent DRV as established in § 101.9(c)(7)(iii) and (c)(9) (see table 1 of this document for reference values) is required under the heading percent DV for each nutrient for which a DRV was established, except that the percent for protein may be omitted (see § 101.9(d)(7)(ii)). The regulations require that information about these nutrients be declared on the nutrition label and that no nutrients or food components, other than those listed, may be included on the nutrition label (§ 101.9(c)). A statement about the percent of the RDI, expressed as the percent of the DV for vitamin A, vitamin C, calcium, and iron, in that order, is required (see table 1 of this document for reference values) (§ 101.9(c)(8)(ii)). These four vitamin and mineral nutrients are required to be declared because of public health concerns relative to inadequate intake of these nutrients by specific portions of the population, as well as the possible association between the lack of several of these nutrients in the diet and the risk of chronic disease (58 FR 2079 at 2106). The declaration of other vitamins and minerals that have an RDI is required when they are added as a nutrient supplement or when a claim is made about them (§ 101.9(c)(8)(ii)). If the amount of the vitamin or mineral is present at less than 2 percent of the RDI, declaration of an amount is not required or the content may be expressed as zero (§ 101.9(c)(8)(iii)). **Table 1.—Reference Values for Nutrition Labeling (Based on a 2,000 Calorie Intake; for Adults and Children 4 or More Years of Age)** Nutrient 1 Unit of Measure Daily Values Total Fat g 65 Saturated fatty acids g 20 Cholesterol mg 300 Sodium mg 2,400 Potassium mg 3,500 Total carbohydrate g 300 Fiber g 25 Protein g 50 Vitamin A International Units

(IU)5,000 Vitamin C mg 60 Calcium mg 1,000 Iron mg 18 Vitamin D IU 400 Vitamin E IU 30 Vitamin K micrograms (μg) 80 Thiamin mg 1.5 Riboflavin mg 1.7 Niacin mg 20 Vitamin B6 mg 2.0 Folate μg 400 Vitamin B12 μg 6.0 Biotin μg 300 Pantothenic acid mg 10 Phosphorus mg 1,000 Iodine μg 150 Magnesium mg 400 Zinc mg 15 Selenium μg 70 Copper mg 2.0 Manganese mg 2.0 Chromium μg 120 Molybdenum μg 75 Chloride mg 3,400 1 Nutrients in this table are listed in the order in which they are required to appear on a label in accordance with § 101.9(c). This list includes only those nutrients for which a DRV has been established in § 101.9(c)(9) or a RDI in § 101.9(c)(8)(iv). The declaration of other vitamins and minerals with an RDI need not be declared if:

(1)Neither the nutrient nor the component is otherwise referred to on the label or in labeling or advertising and

(2)the vitamins and minerals are required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and included in a food solely for technological purposes and declared only in the ingredient statement (§ 101.9(c)(8)(ii)). Foods that are represented or purported to be for use by infants (up to 12 months of age), children 1 to 4 years of age, pregnant women, or lactating women must use the RDIs that are specified for the intended group (§ 101.9(c)(8)(i)). However, FDA has not codified RDI values to use for these various groups. FDA stated, in the 1995 final rule, that it intended to address the issue of RDIs for all nutrients for the various age groups in a future rulemaking but was not doing so in that rule due to the continuing questions about how to arrive at such values. FDA noted that, for conventional foods, there could be no declaration on labels of foods represented or purported to be for use by infants, children less than 4 years of age, or pregnant or lactating women for vitamin K, selenium, chloride, manganese, chromium, and molybdenum until such time as RDIs are established for such groups (60 FR 67164 at 67171). FDA stated that these six nutrients could be specified in mg or µg amounts in dietary supplements under § 101.36 with an asterisk in the percent DV column that refers to a footnote stating “Daily Value not established.” Prior to the 1995 final rule, FDA noted in the 1993 RDI/DRV final rule that manufacturers have continued to use the nutrient values that were contained in 21 CFR 105.3(b) (FDA deleted this paragraph on March 16, 1979 (44 FR 16005)), as label reference values for use on foods purported or represented to be for use by infants, children under 4 years of age, or pregnant or lactating women, without objection from FDA (58 FR 2206 at 2213). The RDIs for the vitamins and minerals for these groups are listed in a table in the 1993 RDI/DRV final rule as guidance (58 FR 2206 at 2213). Such table does not include the seven nutrients that FDA stated could not be on conventional food labeling for these specific groups in the 1995 final rule. Section 101.9(c)(8)(i) states that all other foods must use the RDI for adults and children 4 or more years of age. 2. Application of DVs Section 403(q) of the act provides discretion to the agency to require information about nutrients on the food label when the agency determines such information will “assist consumers in maintaining healthy dietary practices.” Section 2(b)(1)(A) of the 1990 amendments states that nutrition labeling must “be conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in context of a total daily diet.” In the 1993 nutrient content final rule, FDA stated that “the nutrition label can and should help consumers make informed food choices, and that it can also contribute to consumers maintaining healthy dietary practices” (58 FR 2079 at 2114). While the DVs do not represent dietary goals for individuals, their intended use is to provide an overall population reference value on the food label for the consumer (55 FR 29476 at 29481). In order to determine a nutrition labeling format that could be used most effectively by consumers, FDA conducted consumer research and evaluated research conducted by others in considering requirements for the nutrition label format in the 1993 nutrient content final rule (58 FR 2079 at 2115-2121). Based on the results of several consumer studies that evaluated the ability of nutrition label formats to enable consumers to understand the relative significance of product nutrition information in the context of a total daily diet, FDA concluded the following:

(1)The declaration of nutrient amount information as percentages of DV or the placement of adjectives (e.g., high, medium, or low) next to the nutrient amount information are effective ways to help consumers understand the significance of product nutrition information in the context of the total daily diet;

(2)the percent DV declarations moderate dietary judgments about a food; and

(3)other format elements, such as a list of DRVs for important macronutrients, highlighting, or grouping nutrients according to Dietary Guidelines for Americans, did not help consumers to make better dietary judgments (58 FR 2079 at 2118). Upon reviewing the results of several studies that evaluated the consumer's use of the nutrition label, the two most reported uses identified by FDA were to evaluate nutrition characteristics of single products and to assist in making choices between products (58 FR 2079 at 2121 and references cited therein). Informed choices include making judgments about a food product's contribution to the total diet and making comparisons between the nutritional quality of different food products. Findings from the FDA Food Label Use and Nutrition Education Surveys (FLUNES) conducted in 1994 and 1995 showed that more than half of consumers used the Nutrition Facts label to make a judgment about the overall nutritional quality of a food product, especially the fat content (Ref. 21). 3. Uses of the DVs in Nutrient Content and Health Claims The DVs are used to determine, in part, whether a food or dietary supplement is eligible to bear nutrient content claims or health claims. For nutrient content claims, a food or dietary supplement must contain 10 to 19 percent of the DV per Reference Amount Customarily Consumed

(RACC)in order to be labeled as a good source of a particular nutrient and must contain 20 percent or more of the DV per RACC in order to be labeled as an excellent source of a particular nutrient (§ 101.54(b) and (c)). When a health claim is about the effects at decreased dietary intake levels (i.e., low claim), the levels must meet the definition for use of the term low that has been established for that substance, unless a specific alternative level has been established (§ 101.14(d)(2)(vi)). If no definition for low has been established, the level of the substance must meet the level established in the regulation authorizing the claim. For health claims, when a claim is about the effects of consuming the substance at other than decreased dietary levels (i.e. not a low claim), a food must meet the definition of high (20 percent of the DV) for the substance that is the subject of the claim, if the agency has established a definition for the use of the term “high” for that substance and the agency has not established an alternative level for that nutrient in the health claim regulation (§ 101.14(d)(2)(vii)). For a few health claims authorized in §§ 101.76, 101.78, and 101.79, an eligibility requirement is based upon meeting the definition for a good source (10 percent) of the DV for a particular nutrient. The specific eligibility requirements for each authorized health claim are set forth in subpart E, §§ 101.70 to 101.83. In addition, foods bearing health claims, other than dietary supplements or where otherwise provided for in regulations, must contain 10 percent or more of the DV, prior to any nutrient addition, for one of the following nutrients: Vitamins A, vitamin C, iron, calcium, protein, or fiber (§ 101.14(e)(6)). C. Labeling of Dietary Supplements As part of the implementation of the Dietary Supplement Health and Education Act of 1994, FDA issued final regulations in the **Federal Register** of September 23, 1997 (62 FR 49826), requiring that a Supplement Facts label appear on the label or labeling of all dietary supplements. The Supplement Facts label is similar to the Nutrition Facts label in both content and format. Examples of Supplement Facts labels can be found in appendix B. The Supplement Facts label must include the amount and percent DV of the same nutrients that are required for conventional foods if the nutrients are present in the supplement, as well as the amount of other dietary ingredients present (§ 101.36(b)). Nutrients that have established DVs are listed first, followed by a horizontal line that separates these nutrients from dietary ingredients that have no DVs (e.g., botanicals). The Supplement Facts label must state that percent DVs have not been established for these dietary ingredients and must indicate these ingredients clearly with an asterisk (*) (§ 101.36(b)(3)(iv)). D. IOM DRIs and Acceptable Macronutrient Distribution Ranges Beginning in 1997, the IOM began publishing a series of reports on reference intake values (Refs. 8 to 14), collectively known as the DRIs. The DRIs are defined intake levels and include the AI, estimated average requirement (EAR), RDA, and the tolerable upper intake level (UL). DRIs were set for those vitamins, minerals, and macronutrients that are essential in humans and/or provide a beneficial role in human health. While many of the RDAs were revised for nutrients that had an existing RDA (e.g., iron and vitamin A), some nutrients that had RDAs now have an AI (e.g., calcium and vitamin K). Those nutrients that had an ESADDI, now have either an RDA (copper and molybdenum) or an AI (manganese, fluoride, and chromium). Although not considered to be a DRI that provides a defined intake level, the IOM also set acceptable macronutrient distribution ranges (AMDRs) for carbohydrate (i.e., sugars (mono-, di- and oligosaccharides) and starch), total fat, *n* -3 and *n* -6 polyunsaturated fatty acids, and protein (Ref. 13 and Ref. 16 at p. 93). The DRIs and AMDRs were set for the following life stage groups: Infants (0 to 6 and 7 to 12 months); toddlers (1 to 3 years); boys and girls (4 to 8 years); adolescent boys and girls (9 to 13 and 14 to 18 years); adult men and women (19 to 30, 31 to 50, 51 to 70, and greater than 70 years); and pregnant and lactating women. 1. EAR The EAR for a nutrient is defined as the daily intake value that is estimated to meet the requirement for that nutrient, as defined by a specific criterion of adequacy or optimal health, in half of the apparently healthy individuals in a specific life stage and gender group. This definition of the EAR implies a median, rather than a mean or average. The median and mean would be the same if the distribution of requirements followed a symmetrical distribution. In the case of energy, the IOM set an estimated energy requirement

(EER)to represent the average dietary energy intake that is predicted to maintain energy balance in a healthy adult of a defined age, gender, weight, height, and physical activity level (PAL). PAL is the ratio of total energy expenditure

(TEE)divided by the basal rate of energy expenditure. The EER equations use one of the four PAL categories: Sedentary, low active, active, and very active. In children and pregnant and lactating women, the EER meets the needs associated with the deposition of tissues or secretion of milk at rates consistent with good health. The EAR and the EER are used for assessing nutrient intakes of groups. For nutrients with an EAR and for the EER, the prevalence of inadequacy in the population group for the nutrient or energy level evaluated is usually the approximate percentage of the population evaluated whose intakes fall below the EAR for the nutrient or the EER (Ref. 22). The EAR for the nutrient and the EER can also be used to plan for an acceptably low prevalence of inadequate intakes within a group. The EAR for a nutrient and the EER should not be used as an intake goal for the individual. Examples of planning for groups include planning diets in an assisted-living facility for senior citizens or planning menus for a school nutrition program (Ref. 15). 2. RDAs The RDA is an estimate of the daily average intake level that meets the nutrient requirements of nearly all (97 to 98 percent) healthy individuals in a particular life stage and gender group and assuming a normal distribution of requirements (Ref. 8). An RDA cannot be set without an EAR. For all nutrients, except iron, the RDA was set based on the EAR plus 2-times the standard deviation

(SD)of the EAR : RDA = EAR + 2 x SD requirement . If data about the variability in the EAR for a nutrient were insufficient to calculate the SD EAR , then a coefficient of variation

(CV)of 10 percent was assumed. If individual intakes have been observed for a large number of days and are at the RDA, or observed intakes for fewer days are well above the RDA, there can be a high level of confidence that the intake is adequate. Under these conditions, RDAs can be used for assessing intakes of individuals for nutritional adequacy. The RDA can also be used to plan for intakes of individuals. The RDA should not be used to plan intakes of groups. The RDA is not used to plan intakes of groups because the median of a target intake distribution for a group will usually exceed the RDA because the variance in usual intakes exceeds the variance in requirements. Thus, the selection of the RDA as the median of the target usual intake distribution for groups is not recommended as it results in a greater percentage of inadequacy. The IOM report on the application of the DRIs in planning diets for individuals provided several examples of nutrient-based food guidance systems that could be used by individuals for planning diets, including food and supplement labels (e.g., the Nutrition Facts label) (Ref. 15). 3. AI If there is insufficient scientific evidence to calculate the EAR and therefore insufficient evidence on which to establish an RDA for an essential nutrient or a nutrient that is beneficial for human health, then an AI is determined. AIs are based on the following:

(1)Scientific evidence for requirements that is insufficient to set an EAR (e.g., calcium, vitamin D, choline, biotin, fluoride, sodium);

(2)experimental data on risk reduction of chronic disease that are insufficient to set an EAR (e.g., dietary fiber, potassium); or

(3)median intakes of a nutrient usually using national nutrition intake survey data, provided there is no evidence of a deficiency of the nutrient in the United States (e.g., pantothenic acid, vitamin K, chromium, manganese, linoleic acid, and α-linolenic acid). There is much less certainty about an AI value than about an RDA value. The AI for a nutrient is expected to exceed the RDA for that nutrient, and therefore it should cover the needs of more than 97 to 98 percent of individuals. The IOM set most AIs for young infants (0 to 6 months of age) based on the average intake of the nutrient consumed exclusively from breastfed infants, provided that breast milk provides a sufficient amount of a nutrient to meet the needs of the infant. The AIs for older infants (7 to 12 months) were set based on:

(1)The average intake of the nutrient consumed exclusively from breastfed infants and, if data were available, average intakes of a nutrient provided by complimentary weaning foods; and/or

(2)extrapolated from the AI of younger infants; and/or

(3)extrapolated from adult AIs; and/or

(4)clinical data. The AIs for iron and zinc for older infants could not be set using intake from breast milk because the level of iron and zinc in human milk is not sufficient to meet their needs. For iron, zinc, and protein; EARs and RDAs for older infants 7 to 12 months were set based upon data regarding daily requirements. Usual individual intakes that are equal to or above the AI can be assumed adequate. The likelihood of inadequacy of usual intakes below the AI cannot be determined since there is insufficient information of the distribution of requirements. The AI can also be used to plan for intakes of individuals (Ref. 15). 4. UL The UL is the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects for almost all individuals in the specific life stage group. As intake increases above the UL, there is a potential for an increased risk of adverse effects. The UL is not intended to be a recommended level of intake, as there is no established benefit for healthy individuals if they consume a nutrient in amounts exceeding the RDA or AI. The UL can be used to estimate the percentage of the population at potential risk of adverse effects from excess nutrient intake. The UL can also be used to plan for usual intakes below this level for an individual or in planning to minimize the proportion of the population at risk of excess nutrient intake (Ref. 15). 5. AMDR An AMDR is a range of intakes for a particular energy source (e.g., fat, fatty acids, carbohydrate, and protein) that is associated with reduced risk of chronic disease while providing adequate intakes of essential nutrients. The AMDR of a macronutrient (e.g., fat) is expressed as a percentage of total energy intake because its requirement is dependent on other energy sources (e.g., carbohydrate and protein). If an individual consumes below or above this range, there is a potential for increasing the risk of chronic diseases shown to affect long-term health, as well as increasing the risk of insufficient intakes of essential nutrients. 6. DRIs Set for Macronutrients and Micronutrients Based on the review of all macronutrients and micronutrients that are known to be essential and/or beneficial in humans, the IOM set the DRIs that are listed for each nutrient in tables 2 to 10 of this document. As can be seen from tables 11a and 11b of this document, the population-coverage and population-weighted AIs for fluoride and the population-coverage RDAs for synthetic niacin exceed the UL for children 4 to 8 years. BILLING CODE 4160-01-S EP02NO07.000 EP02NO07.001 EP02NO07.002 EP02NO07.003 EP02NO07.004 EP02NO07.005 EP02NO07.006 EP02NO07.007 BILLING CODE 4160-01-C E. IOM Report on Guiding Principles for Nutrition Labeling In 2003 the IOM committee on nutrition labeling (the IOM Committee) considered how the DRIs can be used to develop appropriate reference values for nutrition labeling (Ref. 16). The IOM Committee's report recommended the following 10 guiding principles for nutrition labeling: • *Nutrition information in the Nutrition Facts label should continue to be expressed as percent DV* . The concept of percent DV was developed by FDA in response to NLEA to help consumers better comprehend the nutritional value of food and to understand its relative significance in the context of a daily diet. The percent DV concept was modeled after the “percent of U.S. RDAs” used in 1973 labeling. The use of the percent DV concept has been supported by consumer studies (58 FR 2079). The IOM Committee concluded that the rationale to use percent DV was compelling and suggested no alternative approach. • *The DVs should be based on a population-weighted reference value using census data and proportions of each life stage and gender group* . The IOM Committee's rationale for using a population-weighted approach was that the DRIs for the various age and gender groups should be represented by the DV of the population in the same proportions. A DV defined this way would represent a central value of the requirement of the base population, with individual requirements varying around this value. As discussed previously in this document, the population-weighted approach is one of two approaches for setting one DV for all individuals 4 years of age and older. Currently, FDA uses the population-coverage approach for setting a single DV which represents the highest recommended intake level among all life stage and gender groups, excluding pregnant and lactating women. Although the degree of change will differ for each nutrient, the DV would be lower using the population-weighted approach for most nutrients when compared to a DV derived using the population-coverage approach (see tables 11a and 11b of this document). Note that if the DV for a nutrient is increased, then a serving of food would have a lower percent DV on the Nutrition Facts label. **Table 11** a. **Comparison of the Current DVs with the EAR, RDA, and UL Using the Population-Coverage or Population-Weighted Approach** Nutrient Unit of Measure Current DV Highest RDA Weighted RDA 1 Highest EAR Weighted EAR 1 UL 4 to 8 years 2 Nutrients Assigned an EAR and RDA Copper mg 2.0 0.9 0.8 0.7 0.7 3 Folate μg 400 400 378 330 304 400 Iodine μg 150 150 144 95 91 300 Iron mg 18 18 11 8 6 40 Magnesium mg 400 420 341 350 283 110 Molybdenum μg 75 45 42 34 32 600 Niacin mg 20 16 14 12 11 15 Phosphorus mg 1,000 1,250 769 1,055 640 3,000 Protein g 50 56 47 46 39 - Riboflavin mg 1.7 1.3 1.1 1.1 0.9 — Selenium μg 70 55 52 45 43 150 Thiamin mg 1.5 1.2 1.1 1.0 0.9 — Vitamin A IU 5,000 3,000 2,511 2,100 1,768 — μg 1,500 RE 900 RAE 754 RAE 630 RAE 531 RAE 900 Vitamin B 6 mg 2.0 1.7 1.3 1.4 1.1 40 Vitamin B 12 μg 6.0 2.4 2.3 2.0 1.9 — Vitamin C mg 60 90 74 75 61 650 Vitamin E IU 30 IU — — — — — mg α-tocopherol 15 14 12 11 300 Zinc mg 15 11 9.1 9.4 7.7 12 1 Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more years of age, using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and Zero International Migration Series, 1999 to 2100 (NP-D1-A), ( *http://www.census.gov/population/www/projections/natdet-D1A.htm* ), U.S. Census Bureau, Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs, AIs, and ULs were multiplied by the population projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old, males 9 to 13 years old). Sum of these values were divided by the total population projection for adults and children 4 or more years of age. 2 The ULs for vitamin E, niacin, and folate apply to synthetic forms obtained from supplements, fortified foods, or a combination of the two. The ULs for vitamin A apply only to preformed vitamin A. The ULs for magnesium represent intake from a pharmacological agent only and do not include intake from food and water. RE=retinol equivalents, RAE=retinol activity equivalents **Table 11** b. **Comparison of the Current DVs with the AIs and ULs Using the Population-Coverage or Population-Weighted Approach** Nutrient Unit Of Measure Current DV Highest AI Weighted AI 1 Highest UL Weighted UL 1 UL 4 to 8 years Nutrients Assigned an AI Biotin μg 300 30 28 — — — Calcium mg 1,000 1,300 1,091 — — 2,500 Chloride mg 3,400 2,300 2,150 3,600 3,536 2,900 Choline mg 550 2 550 460 — — 1,000 Chromium μg 120 35 27 — — — Fiber g 25 38 3 29 3 — — — Linoleic acid g — 17 13 — — — α-Linolenic acid g — 1.6 1.3 — — — Manganese mg 2.0 2.3 1.9 — — 3 Pantothenic acid mg 10 5 5 — — — Potassium mg 3,500 4,700 4,622 — — — Sodium mg 2,400 4 1,500 1,410 2,300 2,265 1,900 Vitamin D IU 400 600 280 — — — μg 10 15 7 50 Vitamin K μg 80 120 95 — — — Fluoride mg — 4 3 — — 2.2 1 Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more years of age, using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and Zero International Migration Series, 1999 to 2100 (NP-D1-A), ( *http://www.census.gov/population/www/projections/natdet-D1A.htm* ), U.S. Census Bureau, Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs, AIs, and ULs were multiplied by the population projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old, males 9 to 13 years old). Sum of these values were divided by the total population projection for adults and children 4 or more years of age. 2 A notification was submitted under section 403(r)(2)(G) of the act (21 U.S.C. 343(r)(2)(G)) in 2001 for the use of certain nutrient content claims for choline. These statements identify the daily value for choline as 550 mg (see footnote 5 of this document). This value is based on the AI set by the IOM of the NAS in 1998 (Refs. 9 and 20). 3 Based on AI of 14g/1,000 calories. 4 Daily reference value to not be exceeded. • *A population-weighted EAR should be the basis for DVs for those nutrients for which EARs have been identified* . The Committee's rationale for using an EAR, rather than the RDA, to set the DV was the Committee's belief that the EAR represents the most accurate representation of the true contribution of food to total nutrient needs in the general population. Currently, the RDIs are based on RDAs, when available. There are 16 nutrients for which the DV is currently based on an RDA and now have a new EAR and RDA. 6 Because the RDA is 2 standard deviations greater than the EAR, a DV based on an EAR would be lower than when based on the RDA (see table 11a of this document). The population-weighted EAR yields the lowest values compared to population-coverage RDA, population-weighted RDA, or population-coverage EAR (see table 11a of this document). The population-weighted EAR can vary from as little as 21 percent lower than the population-coverage RDA for vitamin B 12 , to 41 percent lower for vitamin A, to as much as 67 percent lower for iron. 6 Currently there are DVs that were based on RDAs for vitamin A, vitamin C, iron, vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, phosphorous, iodine, magnesium, zinc, selenium, and protein. • *If no EAR has been set for a nutrient, then a population-weighted AI should be used as the basis for a DV* . An AI is a proxy for an RDA, however, the AI is not the equivalent of an EAR. Thus, when an AI is set for a nutrient, there is no other recommended intake level that is set for that nutrient. AIs were determined for 15 nutrients (tables 2 and 3 of this document). As can be seen in table 11b of this document, a reference value for labeling based on a population-weighted AI is lower for most nutrients than a reference value that is derived based on the population-coverage approach that uses the highest AI. As discussed previously in this document, AIs for children and adults were based on experimental data that were not sufficient for setting an EAR or were based on median intake levels. The IOM labeling report did not address the issue of whether AIs based on either approach should or should not be considered in setting a DV. The IOM labeling report did not address the AIs set for sodium and potassium because the IOM DRI report on electrolytes and water was not completed (Ref. 14). • *The AMDR should be the basis for the DVs for protein, total carbohydrate, and total fat* . The IOM labeling committee recommended that using the AMDRs to set reference values for protein, total carbohydrate, and total fat is appropriate to promote healthful dietary practices and nutritionally adequate diets and would provide consistency. Because the IOM set AMDRs (percent of energy) for all three macronutrients, the IOM Committee recommended setting the DV based on the following:

(1)The midpoint of the AMDR for carbohydrate (starch and sugars),

(2)a population-weighted midpoint of the AMDR for total fat since AMDRs varied for age, and

(3)the difference (100 percent of energy - (DV fat + DV carbohydrate )) for protein. The IOM Committee stated that using the midpoint of the AMDR values avoids extreme values from the upper or lower boundaries and is an approach that focuses on moderation. The IOM Panel on Macronutrients did not set a UL for total or added sugars, but identified a suggested maximum intake level of no more than 25 percent of energy from added sugars. However, the IOM Committee recommended against using this value for nutrition labeling because it could be misrepresented as a desirable intake level. Although the IOM panel on macronutrients set an AMDR for protein, they also set EARs and RDAs for protein (see tables 11a and 12 of this document). Currently, the DV for protein is based on 10 percent of 2,000 calories using an adjusted average of the 1989 RDA (Ref. 3). Although protein has a DV, the declaration of a percent DV for protein on the label is optional unless a claim is being made. The declaration of a percent DV for protein is optional due, in part, to the cost consideration of determining the protein digestibility-corrected amino acid score which is necessary to calculate the percent DV of protein (58 FR 2079 at 2102). **Table 12.—Comparison of the Current DVs in Grams to the Lower, Midpoint, and Upper Acceptable Macronutrient Distribution Ranges for a 2,000 Calorie Diet** Nutrient Current DV Percent of Energy Grams (for 2,000 calories per day) AMDR Percent of energy Low Midpoint High AMDR Grams (for 2,000 calories per day) 1 Low Midpoint High Adults Protein 10 50 10 22.5 35 50 112.5 175 Fat 30 2 65 20 27.5 35 44.4 61.1 77.7 Linoleic acid — — 5 7.5 10 11 17 22 α-Linolenic — — 0.6 0.9 1.2 1.3 2 2.7 Carbohydrate 60 300 3 45 55.0 65 225 4 275 4 325 4 Protein by difference 17.5 87.5 Total energy 100 100 Children Age 4 to 18 Years Protein 10 50 10 20 30 50 100 150 Fat 30 2 65 25 30 35 55.6 66 77.7 Linoleic acid — — 5 7.5 10 11 17 22 α-Linolenic — — 0.6 0.9 1.2 1.3 2 2.7 Carbohydrate 60 300 3 45 55 65 225 4 275 4 325 4 Protein by difference 15 75 Total energy 100 100 Age 4 Years and Older (Weighted per IOM Labeling Report, Table B-4) Fat 5 30 2 65 21 28 35 46.7 62 77.7 Linoleic acid — — 5 7.5 10 11 17 22 α-Linolenic — — 0.6 0.9 1.2 1.3 2 2.7 Carbohydrate 6 60 300 3 45 55 65 225 4 275 4 325 4 Protein by difference 7 34 17 0 170 85 0 Total energy 100 1 Derived by converting percent energy to g/d using Atwater factors 4 calories/g for carbohydrates and protein and 9 calories/d for fat for a 2,000 calories diet. 2 Based on a Dietary Guideline recommendation of no more than 30 percent of energy from fat. 3 Carbohydrate represents sugars, starch, fiber, and organic acids. 4 Carbohydrate represents starch and sugars. 5 The AMDR for total fat is comprised of population-weighted values computed based on U.S. Census Bureau estimates of the U.S. population in 2005. 6 No weighting was done for this group. 7 Calculated using the difference (100 percent of energy - (DV fat + DV carbohydrate )) for protein. For the purpose for food labeling, total carbohydrate in food is currently calculated by subtraction of the sum of crude protein, total fat, moisture, and ash from the total weight of the food and includes starch, sugars, sugar alcohols, and fiber (§ 101.9(c)(6)). The current DV for total carbohydrate is based on the 100 percent of energy minus the sum of the DV for fat (30 percent) plus the DV for protein (10 percent). Thus, the DV is 60 percent of a 2,000 calorie diet (300 g) for total carbohydrate. In contrast to the calculation of total carbohydrates (§ 101.9(c)(6)), the IOM panel on macronutrients set an AMDR for carbohydrates and also set an EAR and RDA for carbohydrate that specifically represents starch and sugars, but does not include sugar alcohols or fiber (see tables 8, 10, and 12 of this document). Therefore, the recommendation by the IOM Committee to use the AMDR for setting a DV for total carbohydrate would limit the definition and corresponding DV to sugars and starch. The current DV for fat (65 g) is based on the NAS Diet and Health Report (Ref. 4) which recommended no more than 30 percent of energy from fat and represents triglyceride content (§ 101.9(c)(2)). The IOM panel on macronutrients set AMDRs for total fat and fatty acids linoleic and α-linolenic acid (see table 12 of this document). The IOM panel on macronutrients also set AIs for linoleic and α-linolenic acid (see table 11b of this document). Table 12 of this document shows the current DV, the lowest, the midpoint, and the highest value for each AMDR set by the IOM DRI panel on macronutrients, and the AMDRs adjusted using the population-weighted approach. As can be seen in table 12 of this document for fat, linoleic acid, α-linolenic acid, and carbohydrate, the lowest, the midpoint, and the highest AMDR values are similar to the values obtained using the population-weighted AMDRs. The approach that was recommended by the IOM Committee, i.e., using the midpoint of the AMDR for fat and carbohydrate as the basis for label reference values, would yield values of 62 g/d of fat, 85 g/d protein, and 275 g/d carbohydrate. • *Two thousand calories should be used, when needed, as the basis for expressing energy intake when developing DVs* . Although EERs were set for all life-stage groups (Ref. 13), the IOM Committee recognized that the EERs are dependent upon height, weight, and physical activity level. In addition, the EER equations are based on normal weight individuals, and the United States has a high prevalence of obese and overweight individuals (64 percent of adults and 15 percent of children) (Ref. 16). The IOM Committee found that the data necessary to use the EER to derive a calorie reference value is incomplete. Therefore, the IOM Committee recommended retaining the current 2,000 calorie reference level (Ref. 16). • *The DVs for saturated fatty acids, trans fatty acids, and cholesterol should be set at a level that is as low as possible in keeping with an achievable health-promoting diet* . The rationale for this recommendation is based on the DRI macronutrient report (Ref. 13) which did not set ULs but recommended that saturated fatty acid, *trans* fatty acid and cholesterol intakes should be as low as possible while consuming a nutritionally adequate diet. The current DV for saturated fat (not more than 10 percent of energy (20 g/d) and cholesterol (300 mg/d)) is based on the NAS Diet and Health Report (Ref. 4). For FDA to establish a DV for *trans* fatty acids, saturated fat, and cholesterol, the IOM Committee suggested that FDA use food composition data, menu modeling, and data from dietary surveys to estimate minimum intakes consistent with nutritionally adequate and health-promoting diets for diverse populations. In April of 2004, FDA held a meeting of the Nutrition Subcommittee of the Food Advisory Committee on total fat and *trans* fat (the subcommittee) (Ref. 23). The subcommittee concluded that currently there is not enough scientific evidence to recommend a specific acceptable daily intake for *trans* fatty acids. • *While the general population is best identified as all individuals 4 years of age and older, four distinctive life stages were identified for developing separate DVs: Infants (< 1 year), toddlers (1 to 3 years), pregnancy, and lactation* . Because infants, toddlers, and pregnant women and lactating women have specific nutritional needs, the IOM Committee stated that a single DV for the entire population could over- or underestimate the nutrient contribution of foods for these four groups. Therefore, the IOM Committee recommended that separate DVs for foods manufactured specifically for these four groups be used for that specific life-stage group. See discussion in section I.B.1 of this document on requirements for foods that are represented or purported to be for the use of infants (up to 12 months of age) or children 1 to 4 years of age, and pregnant women or lactating women. • *The Supplement Facts label should use the same DVs as the Nutrition Facts label* . The IOM Committee recommended that all other guiding principles should apply to dietary supplement labeling. The IOM Committee came up with this recommendation because the Supplement Facts label requires the inclusion of the percent DVs for the nutrients that are mandated for conventional food (21 U.S.C. 321(ff)). Therefore, the comparisons that are shown for the Nutrition Facts label in tables 11a and 11b of this document are the same for the Supplement Facts label. • *Absolute amounts should be included in the Nutrition Facts and Supplement Facts labels for all nutrients* . The IOM Committee concluded that including absolute amounts (e.g., mg/serving) would assist consumers who want nutrient information but are yet unable to understand the percent DVs. Furthermore, absolute amounts for macronutrients are already required on the Nutrition and Supplement Facts labels. Therefore, the IOM Committee stated that adding absolute amounts for micronutrients would make the labeling consistent. The IOM Committee also recommended that the units used for vitamin A (IU), vitamin D (IU), vitamin E (IU), folate (µg), copper (mg), sodium (mg), potassium

(mg)and chloride

(mg)be changed to be consistent with the units in the new DRI reports (vitamin A (µg Retinol Activity Equivalents), vitamin D (µg), vitamin E (mg α-tocopherol), folate (µg dietary folate equivalents), copper (µg), sodium (g), potassium (g), and chloride (g)). F. IOM Report on the Definition of Fiber 1. Definitions Because there is not a formal definition for dietary fiber, dietary fiber is the material isolated using AOAC INTERNATIONAL Enzymatic-Gravimetric Method 985.29 (Ref. 12). This method includes lignin and nonstarch polysaccharides and some resistant starch, inulin, chitin, chitosan, chondroitin sulfate, and noncarbohydrate material. This method does not include oligosaccharides, polydextrose, or resistant maltodextrins. Currently, dietary fiber is indented under “Total Carbohydrates” in the Nutrition Facts label (§ 101.9(c)(6)(i)). In 2001 the IOM Panel on the Definition of Dietary Fiber (the IOM Panel) responded to FDA's request to provide definitions for dietary fiber based on its role in human physiology and health. The IOM Panel developed two categories of definitions of fiber: “Dietary Fiber” and “Functional Fiber” (Ref. 12). See table 13 of this document from the IOM Report on the Definition of Dietary Fiber, which lists the characteristics of dietary fiber currently determined by FDA and by the IOM definitions for dietary and functional fibers. **Table 13.—Characteristics of Various Dietary Fiber Definitions** 1 Reference Nondigestible Animal CHOs 2 CHOs Not Recovered by Alcohol Precipitation 3 Nondigestible Mono- and Disaccharides Lignin Resistant Starch Intact, Naturally Occurring Food Sources Only Resistant to Human Enzymes Specifies Physiological Effect U.S. Food and Drug Administration (USFDA), 1987 4 Yes Some inulin No Yes Some No No No Institute of Medicine

(IOM)(Proposed), 2001 *Dietary Fiber* No Yes No Yes Some Yes Yes No *Added Fiber* Yes Yes Yes Yes Yes No Yes Yes 1 All definitions are assumed to include nonstarch polysaccharides. 2 CHO = carbohydrate. 3 Includes inulin, oligosaccharides (3-10 degrees of polymerization), fructans, polydextrose, methylcellulose, resistant maltodextrins, and other related compounds. 4 Method-based definition. Source: Adapted from the IOM, “Dietary Reference Intakes: Proposed Definition of Dietary Fiber,” Washington, DC: National Academy Press, 2001. a. *The IOM Panel defined “Dietary Fiber” as nondigestible carbohydrates and lignin that are intrinsic and intact in plants* . Nondigestible means that the material is not digested and absorbed in the human small intestine. Fractions of plant foods are still considered “Dietary Fiber” if the plants' cells and their three dimensional interrelationships remain largely intact. Examples of “Dietary Fiber” include cereal brans; resistant starch that is naturally occurring; naturally occurring oligosaccharides such as raffinose, stachyose, verbacose; and low molecular weight fructans. The known physiological benefits of foods containing “Dietary Fiber,” such as attenuation of postprandial blood glucose and cholesterol levels and improved laxation, are recognized. b. *The IOM Panel defined “Functional Fiber” as isolated, nondigestible carbohydrates that have beneficial physiological effects in humans* . “Functional Fibers” can be isolated or extracted nondigestible carbohydrates, using chemical, enzymatic, or aqueous procedures or synthetically manufactured. Provided that one or more beneficial physiological effects are demonstrated in humans, examples of “Functional Fiber” would include isolated nondigestible animal carbohydrates, pectins or gums, resistant starch formed during processing, and synthetic fibers such as resistant maltodextrin and fructooligosaccharides. At this time, current FDA regulations have not established formal criteria for establishing the beneficial physiological effects of potential “Functional Fibers.” c. * The IOM Panel defined “Total Fiber” as the sum of “Dietary Fiber” and “Functional Fiber * .” Thus, while there is currently one category of dietary fiber in the Nutrition Fact label, the Panel has provided three definitions of fiber for potential use. The AI set by the IOM is for “Total Fiber.” 2. Soluble and Insoluble Fiber The IOM Panel recommended that the terms soluble and insoluble fiber be phased out and replaced with an appropriate physicochemical property (e.g., viscous or fermentable fiber) of the specific fiber as these become standardized. This recommendation is based on scientific findings that suggest that the physiological benefit of a fiber (e.g., attenuation of blood glucose and cholesterol concentration and improved laxation) is not related to the solubility of a fiber. There is evidence indicating that viscous fibers and fibers that are slowly, incompletely, or not fermented can provide beneficial physiological effects. The IOM Panel recommended that viscosity or fermentability of a fiber be considered as characteristics to distinguish “Dietary Fibers” and “Functional Fibers” that modulate gastric and small bowel function from those that provide substantial stool bulk which is affected by fiber solubility and may or may not affect gastric and small bowel function. Currently, a statement of the number of grams of soluble (§ 101.9(c)(6)(i)(A)) and insoluble (§ 101.9(c)(6)(i)(B)) dietary fiber can be voluntarily declared and indented under dietary fiber and both are identified and quantified using AOAC INTERNATIONAL methods. 3. Analytical Issues The IOM Panel recognized that adoption of the two definitions for fiber would challenge the currently available analytical methods, requiring changes to the current analytical methods. Particularly, separating out “Dietary” and “Functional Fibers,” of which there could be a potential overlap (e.g., resistant starch and dietary fibers that are extracted, concentrated, and added to foods (gums, cellulose, pectin)). The IOM Panel proposed modifications to the current methods. While further refinement of these methods is made, the IOM Panel indicated that it would be more practical to determine “Total Fiber” using the current methods. G. Current Regulations on Trans Fat In the **Federal Register** of July 11, 2003 (68 FR 41434), FDA amended its regulations on nutrition labeling to require *trans* fatty acids be declared in grams per serving in the nutrition label of conventional foods and dietary supplements (the 2003 *trans* fat final rule). No DV was established for *trans* fatty acids. Required labeling became effective on January 1, 2006. In the **Federal Register** of July 11, 2003 (68 FR 41507), FDA published an ANPRM (the 2003 *trans* fat ANPRM) to solicit information and data that potentially could be used to establish new nutrient content claims about *trans* fatty acids; to establish qualifying criteria for *trans* fat in current nutrient content claims for saturated fatty acids and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices. FDA also requested comments on whether it should consider statements about *trans* fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts label or as a disclosure statement in conjunction with claims to enhance consumer understanding about cholesterol-raising lipids and how to use the information to make healthy food choices. On March 1, 2004 (69 FR 9559), FDA reopened the comment period for the 2003 *trans* fat ANPRM to receive comments that considered the information in the 2003 IOM report on nutrition labeling (Ref. 16) that addressed the labeling of *trans* fat (see section II.E of this ANPRM). In addition to the questions raised in the 2003 *trans* fat ANPRM, FDA sought comments on the 2003 IOM labeling report's approach to establish a DV using food composition data, menu modeling, and dietary survey data to estimate a minimum *trans* fat intake within a nutritionally adequate diet. FDA also sought comment on whether the IOM approach of using food composition data, menu modeling, and dietary survey data should be used to revise the DV for saturated fat. Public comments were also sought on the IOM recommendation to list saturated fat and *trans* fat on separate lines of the Nutrition Facts label, but have one numerical value for the percent DV for these two nutrients together. In addition, if FDA were to use one numerical value for the percent DV for both *trans* fat and saturated fat together, the agency asked for comment about whether such value should be determined by adding a new DV established for saturated fat to the DV for *trans* fat, or, alternatively, whether the agency should establish a joint DV for saturated and *trans* fats that would then be used to calculate one numerical value as the percent DV for both fats. On April 19, 2004 (69 FR 20838), FDA extended the comment period for the 2003 *trans* fat ANPRM to receive comments that considered the information in the 2004 subcommittee meeting (Ref. 23) that addressed whether the available scientific evidence supports listing the percent DV for saturated fat and *trans* fat together or separately on the Nutrition Facts label and what the maximal daily intake of *trans* fat may be. Because of their relevance to the Nutrition Facts label, FDA intends to consider, as comments to this ANRPM, the comments to the 2003 *trans* fat ANPRM on the IOM approach for calculating a DV for saturated fat and *trans* fat and listing of saturated and *trans* fats on separate lines of the Nutrition Facts label with one numerical value for the percent DV for both, and how to calculate the percent DV as one numerical value. Comments to the 2003 *trans* fat ANPRM on the outcome of the subcommittee meeting will also be considered. Public comments on these issues are being asked again in this ANPRM so that these issues can be considered in the context of the entire Nutrition Facts and Supplement Facts labels along with other questions being asked in this ANPRM. H. ANPRM on Prominence of Calories In the **Federal Register** of April 4, 2005 (70 FR 17008), FDA published an ANPRM on the prominence of calories on the food label (the 2005 ANPRM). The 2005 ANPRM was issued in response to recommendations from the Obesity Working Group

(OWG)created by the Commissioner of Food and Drugs to develop an action plan to address the growing incidence of obesity in the United States. The 2005 ANPRM, in part, requested comments on whether giving more prominence to the declaration of calories per serving would increase consumer awareness of the caloric content of the packaged food. FDA also sought comment of whether providing a percent DV for total calories would help consumers understand the caloric content of the packaged food in the context of a 2,000 calorie diet. In addition, FDA also requested comments on questions posed concerning the declaration of “calories from fat” (70 FR 17008 at 17010). Because of their relevance to the Nutrition Facts label, FDA intends to consider, as comments to this ANRPM, comments to the 2005 prominence of calories ANPRM related to questions posed on a percent DV for total calories and calories from fat. Public comments on the specific question about establishing a percent DV for total calories and the questions posed concerning “calories from fat” are being requested in this ANPRM so that these questions can be considered in the context of the entire Nutrition Facts and Supplement Facts labels along with other questions being asked in this ANPRM. I. Carbohydrate Content of Food FDA received nine citizen petitions that requested, among other things, that the agency amend our nutrition labeling requirements related to the declaration of total carbohydrate content of foods. 7 With respect to carbohydrate labeling, the agency is requesting comment in this ANPRM on questions related to the label declaration of carbohydrate in the Nutrition Facts and Supplement Facts labels (see section II.C.10 of this document). 7 The nine citizen petitions can be found in Docket Nos. 2004P-0105/CP1, 2004P-0107/CP1, 2004P-0110/CP1, 2004P-0297/CP1, 2004P-0298/CP1, 2004P-0299/CP1, 2004P-0293/CP1, 2004P-0473/CP1, 2004P-0542/CP1. J. “2005 Dietary Guidelines for Americans” The “2005 Dietary Guidelines for Americans” (the 2005 Dietary Guidelines) developed jointly by the U.S. Department of Health and Human Services and the U.S. Department of Agriculture provide several key numerical recommendations with respect to micronutrients and macronutrients, of which most are based on the DRI reports (Ref. 7). These recommendations are as follows: • Consume less than 10 percent of calories from saturated fat and less than 300 mg/d of cholesterol. These recommendations are the same as the current DRVs for saturated fat and cholesterol. • Keep total fat intake between 20 and 35 percent of calories, the AMDR for total fat. • Consume less than 2,300 mg/d of sodium, the UL for sodium. The 2005 Dietary Guidelines also identified nutrients of concern based on dietary intake data or evidence of public health problems. The nutrients of concern are identified for: • Adults: Calcium, potassium, fiber, magnesium, and vitamins A (as carotenoids), C, and E; • Children and adolescents: Calcium, potassium, fiber, magnesium, and vitamin E. The 2005 Dietary Guidelines also identified nutrients of concern for specific populations groups. Vitamin B12 was identified as a nutrient of concern for people over the age of 50. Iron was identified as a nutrient of concern for women of childbearing age who may become pregnant. Folic acid was also identified as a nutrient of concern for women of childbearing age who may become pregnant and those in the first trimester of pregnancy. Vitamin D was identified as a nutrient of concern for older adults, people with dark skin, and people exposed to insufficient ultraviolet band radiation (i.e., sunlight). II. Agency Request for Information FDA has not updated or set new DVs since 1995. In 2003, the IOM completed its first review of nutrients using the DRI process. This review has generated discussion in the scientific community. FDA plans to revise the reference values used for the Nutrition Facts and Supplement Facts labels. FDA requests comments on the following questions. As part of the comments, FDA requests that scientific justification be submitted in support of the response. FDA recognizes that an individual commenter may choose to respond to all of the questions or only a subset, based on his/her area of expertise. A. Approach to Setting DVs As discussed in section I.D of this document, beginning in 1997, the IOM began publishing a series of reports on reference intake levels, collectively known as the DRIs. The DRIs provided revised RDAs and three new reference intakes for nutrients (AI, EAR, and UL). The IOM also reported on AMDRs for macronutrients. FDA requests comments on the following questions on which DRIs and AMDRs should be used for setting DVs. • Should the DV be based on an EAR for those nutrients for which an EAR has been set? Explain why or why not. • If EARs are used to set DVs, should they be set based on population-coverage or population-weighted EAR? Explain why you have chosen a particular approach and why it is preferable to the other approach. Explain why or why not. • Should the DV be set based on an RDA for those nutrients for which an RDA has been set? Explain why you have chosen a particular approach and why it is preferable to the other approach. • If RDAs are used to set DVs, should they be set based on population-coverage or population-weighted RDA? Explain why you have chosen a particular approach and why it is preferable to the other approach. • Should any or all AIs, regardless of how they are derived, be used to set DVs? Explain why or why not. Or, should only those AIs based on experimental data be used to set DVs (i.e., from intervention studies that are designed to evaluate nutrient requirements rather than dietary intake data from national surveys)? Explain why or why not. • If AIs are used to set DVs, should they be set based on population-coverage or population-weighted AI? Explain why you have chosen a particular approach and why it is preferable to the other approach. B. Populations for Which the DVs are Intended Currently the DVs are for persons 4 years of age and older. FDA requests comments on the following questions on the populations for which the DVs should be intended. • Should the DVs continue to be used for persons 4 years of age and older? Explain why or why not. • Should DVs for different life stage groups be developed for labeling of food products specific to these groups, as recommended in the IOM labeling report (i.e., separate DVs: Infants (< 1 year), toddlers (1 to 3 years), pregnancy, and lactation)? Explain why or why not. If so, • Should DVs for infants (< 1 year) be set based on the EARs, RDAs, or AIs for older infants (7 to 12 months)? Explain why you have chosen a particular approach and why it is preferable to the other approaches. • Should DVs for toddlers (1 to 3 years) be set based on the EARs, RDAs, or AIs for toddlers (1 to 3 years)? Explain why you have chosen a particular approach and why it is preferable to the other approaches. • Should DVs for pregnant women be set based on the population-weighted or population-coverage EARs, RDAs, or AIs for all DRI pregnancy groups (i.e. 14 to 18 years, 19 to 30 years, 31 to 50 years)? Explain why you have chosen a particular approach and why it is preferable to the other approaches. • Should DVs for lactating women be set based on the population-weighted or population-coverage EARs, RDAs, or AIs for all DRI lactation groups (i.e. 14 to 18 years, 19 to 30 years, 31 to 50 years)? Explain why you have chosen a particular approach and why it is preferable to the other approaches. C. Labeling of Individual Nutrients FDA requests comments on the following questions on individual nutrients: 1. Calories • Should 2,000 calories continue to be used to express reference energy intake, as recommended in the IOM labeling report? Explain why or why not. • Should 2,500 calories also be kept on the label footnote? Explain why or why not. • Should the EER (Estimated Energy Requirements) be used to express reference energy intake? Explain why or why not. • If a population-weighted EER or a population-coverage EER should be used, which PAL (sedentary, low active, active, very active) should be used to calculate the EER? Explain why you have chosen a particular approach and why it is preferable to the other approaches. • Would providing for a percent DV disclosure for total calories assist consumers in understanding the caloric content of the packaged food in the context of a 2,000 calorie diet? Explain why or why not. 2. Calories From Fat • What data are there on how consumers use the listing of “Calories from fat?” • How does the listing “Calories from fat” adjacent to “Calories” affect consumers' focus on the total calories of a food? • What are the advantages or disadvantages of eliminating the listing for “Calories from fat” from the nutrition label? • What data would be needed to determine whether the listing of “Calories from fat” is or is not necessary to assist consumers in maintaining healthy dietary practices? 3. Calories From Saturated Fat • Should calories from saturated fat continue to be voluntary or should it be made mandatory on the food label? Explain why you have chosen a particular approach and why it is preferable to the other approach. 4. Total Fat • Should a population-weighted midpoint of the AMDR (e.g. 28 percent for adults) be used, as suggested in the IOM labeling report? Explain why or why not. *Note: 28 percent of 2,000 calories/d is 560 calories/d. 560 calories/d divided by 9 calories/g is 62 g/d* . • Should the upper range of AMDR of 35 percent be used? Explain why or why not. *Note: This would increase the DRV from 65g/d to 78 g/d for 2,000 calorie diet. 35 percent of 2,000 calories is 700 calories. 700 calories divided by 9 calories/g is ~ 78g* . 5. Saturated Fat • Should the current DRV of 20g/d from saturated fat remain, as recommended by the 2005 Dietary Guidelines? Explain why or why not. • Should food composition data, menu modeling, and data from dietary surveys be used to establish a DRV for saturated fat that is as low as possible while consuming a nutritionally adequate diet, as recommended in the IOM labeling report? Explain why or why not. 6. *Trans* Fat • Should food composition data, menu modeling, and data from dietary surveys be used to establish a DRV for *trans* fat that is as low as possible while consuming a nutritionally adequate diet, as recommended in the IOM labeling report? Explain why or why not. • Should saturated fat and *trans* fat be listed on separate lines of the Nutrition Facts label, but have one numerical value for the percent daily value for these two nutrients together, as recommended in the IOM labeling report? Explain why or why not. • If one numerical value is used for the percent DV for both *trans* fat and saturated fat together, should such value be determined by adding the DV for saturated fat to the DV for *trans* fat, or, alternatively, should the agency directly establish a joint DV for saturated and *trans* fats that would then be used to calculate one numerical value as the percent DV for both fats? 7. Polyunsaturated Fat • Should polyunsaturated fat continue to be voluntary or should it be made mandatory on the food label? Explain why you have chosen a particular approach and why it is preferable to the other approach. • Should a DRV for polyunsaturated fat ( *n* -3 plus *n* -6) be established using the AMDRs for *n* -6 (5-10 percent) and *n* -3 (0.6-1.2 percent) of total calories? If so, should the midpoint be used? Explain why or why not. *Note: 7.5 percent (midpoint) for n-6 and 0.9 percent (midpoint) for n-3 of 2,000 calories =19g/d polyunsaturated fat* . • Should a DRV for polyunsaturated fat be derived based upon AIs for linoleic acid ( *n* -6 polyunsaturated fat) plus α-linolenic acid ( *n* -3 polyunsaturated fat)? Explain why or why not. • Should separate DRVs for linoleic acid ( *n* -6 polyunsaturated fat) and α-linolenic acid ( *n* -3 polyunsaturated fat) be established? Explain why or why not. • If separate DRVs for linoleic acid ( *n* -6 polyunsaturated fat) and α-linolenic acid ( *n* -3 polyunsaturated fat) are established should they be voluntary or should they be made mandatory on the food label? Explain why you have chosen a particular approach and why it is preferable to the other approach. 8. Monounsaturated Fat • Should monounsaturated fat continue to be voluntary or should it be made mandatory on the food label? Explain why you have chosen a particular approach and why it is preferable to the other approach. 9. Cholesterol • Should the current cholesterol DRV of 300 mg/d remain, as recommended by the “2005 Dietary Guidelines for Americans”? Explain why or why not. • Should food composition data, menu modeling, and data from dietary surveys be used to establish a DRV for cholesterol that is as low as possible while consuming a nutritionally adequate diet, as recommended in the IOM labeling report? Explain why or why not. 10. Carbohydrate • Should the current approach for calculating grams of total carbohydrate by difference (see section I.E of this document) continue to be used? Explain why or why not. If not, what other approach or method do you recommend? If so, what should be included or excluded in the current calculation of “total carbohydrate”? • The 2005 Dietary Guidelines recommends consuming fiber-rich foods. Would the separation of dietary fiber from the “total carbohydrate” declaration in nutrition labeling affect consumer understanding of label information and its application to dietary guidelines and what would be the impact, if any, on fiber consumption? • Should “sugars” continue to be included in the Nutrition Facts label? • Should additional types of carbohydrate (e.g., starch) be listed separately in the Nutrition Facts label? Explain why or why not. • Should carbohydrates be classified and declared in nutrition labeling based on their chemical definition or on their physiological effect? Explain why you have chosen a particular approach and why it is preferable to the other approach. If based on a physiologic effect, should the DV for carbohydrate (i.e., sugars and starch) be based on the midpoint of the AMDR (i.e., 55 percent)? Explain why or why not. *Note: 55 percent of 2,000 calories/d is 1,100 calories. 1,100 calories divided by 4 calories/g would be 275 g/d.* 11. Dietary Fiber • Should FDA continue to use the AOAC INTERNATIONAL methods to determine dietary fiber? If not, what other or additional methods should be used? • Should the IOM dietary fiber and/or functional fiber definitions replace the current FDA definition for dietary fiber? Explain why or why not. • Do you recommend another name for functional fiber? If so, what do you recommend and why? • Until FDA identifies functional fibers and analytical methods are established for distinguishing functional fiber from dietary fiber, should total fiber be used on the label to represent dietary fiber? Explain why or why not. 12. Soluble and Insoluble Fiber • Should soluble and insoluble fiber continue to be voluntary or should they be made mandatory on the food label? Explain why you have chosen a particular approach and why it is preferable to the other approach. • Should the terms soluble fiber and insoluble fiber be changed to viscous and nonviscous fiber, as suggested by the IOM? Explain why or why not. 13. Sugar Alcohols • Should sugar alcohols continue to be voluntary or should they be made mandatory on the food label? Explain why you have chosen a particular approach and why it is preferable to the other approach. • How should the energy contribution of sugar alcohols be represented on the label since energy values vary (e.g., from 0.2 calories/g for erythritol to 3.0 calories/g for hydrogenated starch hydrolysates)? • FDA has not defined how it would determine available energy from sugar alcohols. What analytical methods could be used to determine the energy contribution of sugar alcohols? 14. Protein • Should the DRV be based on the approach recommended in the IOM labeling report (100 percent—(DV fat + DV carbohydrate ))? Explain why or why not. • Should the DRV be based on the midpoint of the AMDR for protein (i.e., 17 percent)? Explain why or why not. *Note: Based on 2,000 calories/d, the DRV would be 85 g/d* . • Should the DRV for protein be based on the EAR or RDA for protein? Explain why you have chosen a particular approach and why it is preferable to the other approach. 15. Sodium • Should the DRV for sodium be based on the UL for sodium (2,300 mg/d) as suggested by the 2005 Dietary Guidelines for Americans or should it be based on the AI (1,500 mg/d using the population-coverage approach)? Explain why you have chosen a particular approach and why it is preferable to the other approach. • If the UL should be used, should it be adjusted using the same approach (population-weighted or population-coverage) as the other DRIs? Explain why or why not. 16. Chloride The IOM set an AI and UL for chloride on an equi-molar basis to that of sodium since most sodium is consumed in the form of sodium chloride. • Should the DV for chloride continue to be an RDI, or should it be a DRV like sodium? Explain why you have chosen a particular approach and why it is preferable to the other approach. • Should the DV for chloride be based on the same DRI (AI versus UL) as used to set a DV for sodium? Explain why or why not. 17. Vitamins and Minerals Currently vitamin A, vitamin C, calcium, and iron are mandatory on the food label because they were considered to be of public health concern. • Are vitamin A, vitamin C, calcium, and iron still considered to be of public health concern? Explain why or why not. • Are there other micronutrients that should be of public health concern? Please be specific in describing what, if any, other micronutrients are of public health concern and why. • For those nutrients given an AI under the DRI process, but currently have a DV based on an earlier RDA (e.g., calcium, vitamin K, vitamin D, pantothenic acid, biotin), should the current DV be retained or should the newer AI be used to develop a new DV? Explain why you have chosen a particular approach and why it is preferable to the other approach. • Currently there is no DV for fluoride. Since the IOM established an AI for fluoride, should there be a DV for fluoride? Explain why or why not. D. Other Questions • Should the IUs that are currently used for the DVs for vitamins A, D, and E be changed to µg RAE (retinol activity equivalents), µg, and mg α-tocopherol, respectively? Explain why or why not. • Should the current DV units for folate (µg), copper (mg), chloride (mg), potassium (mg), and sodium

(mg)be changed to be consistent with the units in the IOM DRI reports (folate (µg dietary folate equivalents), copper (µg), chloride (g), potassium (g), and sodium (g))? Explain why or why not. • Should the Supplement Facts label use the same DVs as the Nutrition Facts label, as suggested in the IOM labeling report? Explain why or why not. • Should absolute amounts (e.g., grams or milligrams) be included in the Nutrition Facts and Supplement Facts labels for mandatory and voluntary nutrients? Explain why or why not. E. Process Questions The following question seeks information on the process issues related to the Nutrition and Supplement Facts labels. • If FDA includes functional fiber in the Nutrition Facts labels, should FDA develop criteria for identifying fibers that meet the definition of functional fiber (i.e., demonstrates a physiological benefit)? If so, what should those criteria be? F. Questions on Consumer and Producer Use and Understanding of DVs To help determine which regulatory options might address problems associated with food package labels reflecting current DVs, we request comments including available data on the following questions: • In the 2002 Health and Diet Survey (Ref. 24), respondents were asked how they use the Nutrition Facts label. The most common answers were as follows:

(1)To see if the product was high or low in a specific nutrient,

(2)to get a general idea of the nutritional content of food, and

(3)to decide which brand to purchase and to compare different food items. Do you have information indicating how the percent DV found in the Nutrition Facts label facilitates any of these uses by consumers? For which food products and nutrients? • Currently, a percent DV is required for most nutrients listed in the Nutrition Facts label. Do you have any information indicating that there are nutrients for which consumers would value percent DV information, but such nutrients are not currently found in the Nutrition Facts label? • Do you have information suggesting the degree to which the percent DV is helpful for making purchases? For which food products? For which nutrients? • Do you have information suggesting differences between the degree to which the percent DV is helpful for making purchases intended for consumers 4 years of age and older, children younger than 4 years of age, infants, and pregnant women and lactating women? For which food products? For which nutrients? The following questions address information needed by FDA to analyze the implications of changes in the percent DVs on consumer and producer behavior. • Do you have any information suggesting that changes in percent DV (higher or lower), for a nutrient per serving, would cause consumers to reduce their consumption of some products or product categories and increase their consumption of other products or product categories? If so, changes in the percent DVs of which nutrients would cause changes in the consumption of which products or product categories? Why? • If changes in the percent DVs of some nutrients would alter the eligibility of some products or product categories to make nutrient content claims or health claims, do you have any information suggesting that manufacturers would reformulate or re-label some of their products in order to make a nutrient content claim or a health claim? If so, changes in the percent DVs of which nutrients would cause which products or product categories to be reformulated in order to make a nutrient content claim or health claim? • If changes in the percent DVs of some nutrients would cause some products or product categories to be reformulated or re-labeled in order to make a nutrient content claim or a specific health claim, do you have any information suggesting that there are public health effects from changes in nutrient intakes and consumption behavior of newly reformulated or re-labeled products or product categories that make these claims? If so, what are the public health effects from changes in nutrient intakes and from changes in the consumption behavior of which newly reformulated products or product categories? • The length of time to comply with any regulation requiring revision to product labels may introduce confusion on the part of consumers during a transition period in which two different percent DVs would be reflected on labels of otherwise identically formulated products. Do you have information suggesting the extent to which such confusion might exist for compliance periods of 6 months, 12 months, and 24 months? For which food products? III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site addresses but is not responsible for subsequent changes to the Web sites after this document publishes in the **Federal Register** . 1. National Research Council (NRC), “Recommended Dietary Allowances, Seventh Edition,” Washington, DC: National Academy Press, 1968. 2. NRC, “Recommended Dietary Allowances, Ninth Edition,” Washington, DC: National Academy Press, 1980. 3. NRC, “Recommended Dietary Allowances, Tenth Edition,” Washington, DC: National Academy Press, 1989. 4. NRC, Executive Summary, “Diet and Health: Implications for Reducing Chronic Disease Risk,” Washington, DC: National Academy Press, pp. 1 to 20, 1989. 5. U.S. Department of Health and Human Services, “The Surgeon General's Report on Nutrition and Health,” Washington, DC, 1988. 6. U.S. Department of Agriculture and U.S. Department of Health and Human Services, “Nutrition and Your Health, Dietary Guidelines for Americans,” Washington, DC: *Home and Gardening Bulletin* No. 232, 3d ed., U.S. Government Printing Office, 1990. Available at *http://www.health.gov/DietaryGuidelines/1990thin.pdf* . 7. U.S. Department of Health and Human Services and U.S. Department of Agriculture, “2005 Dietary Guidelines for Americans,” 6th ed., Washington, DC: U.S. Government Printing Office, 2005. Available at *http://www.health.gov/dietaryguidelines/dga2005/document/.* 8. IOM, Executive Summary, “Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride,” Washington, DC: National Academy Press, pp. 1-20, 1997. 9. IOM, Executive Summary, “Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline,” Washington, DC: National Academy Press, pp. 1 to 16, 1998. 10. IOM, Executive Summary, “Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids,” Washington, DC: National Academy Press, pp. 1 to 20, 2000. 11. IOM, Executive Summary, “Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc,” Washington, DC: National Academy Press, pp. 1 to 28, 2001. 12. IOM, “Dietary Reference Intakes: Proposed Definition of Dietary Fiber,” Washington, DC: National Academy Press, 2001. 13. IOM, Executive Summary, “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids,” Washington, DC: National Academies Press, pp. 1 to 19, 2002. 14. IOM, Executive Summary, “Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate,” Washington, DC: National Academies Press, pp. 1 to 20, 2004. 15. IOM, Executive Summary, “Dietary Reference Intakes: Applications in Dietary Planning,” Washington, DC: National Academies Press, pp. 1 to 17, 2003. 16. IOM, “Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification,” Washington, DC: National Academies Press, 2003. 17. Beaton, G.H., “When Is an Individual an Individual Versus a Member of a Group? An Issue in the Application of the Dietary Reference Intakes.” *Nutrition Reviews* , 64:221-225, 2006. 18. Beaton, G.H., “Choice of DRI Value for Use in Nutrition Labeling.” *Journal of Nutrition* , 137:694-695, 2007. 19. Yates, A.A., “Which Dietary Reference Intake Is Best Suited to Serve as the Basis for Nutrition Labeling for Daily Values?” *Journal of Nutrition* , 136:2457-2462, 2006. 20. FDA, Center for Food Safety and Applied Nutrition, “Nutrient Content Claims Notifications for Choline Containing Foods,” (Internet address: *http://www.cfsan.fda.gov/~dms/flcholin.html* ), August 30, 2001. 21. Derby B., A. Levy, “Do Food Labels Work?” In: *Handbook of Marketing and Society* , Thousand Oaks, CA: Sage, 2000. 22. IOM, Executive Summary, “Dietary Reference Intakes: Applications in Dietary Assessment,” Washington, DC: National Academy Press, 2000. 23. FDA, “Meeting Minutes from the Nutrition Subcommittee of the Food Advisory Committee Meeting on Total Fat and *Trans* Fat,” Washington, DC, April 27 to 28, 2004. Available at *http://www.fda.gov/ohrms/dockets/ac/04/minutes/4035m1_FinalSummaryMinutes.htm* . 24. FDA, “2002 Health and Diet Survey—Preliminary Topline Frequencies (Weighted),” 2004. This ANPRM is issued under section 201 et al. of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et al.) and under authority of the Commissioner of Food and Drugs. **Appendix A** **Acronyms Used in This Document** AI Adequate Intake AMDRs Acceptable Macronutrient Distribution Ranges ANPRM Advance Notice of Proposed Rulemaking CV Coefficient of Variation DRIs Dietary Reference Intakes DRV Daily Reference Value DV(s) Daily Value(s) EAR Estimated Average Requirement EER Estimated Energy Requirement ESADDIs Estimated Safe and Adequate Daily Dietary Intakes FDA Food and Drug Administration FLUNES Food Label Use and Nutrition Education Surveys IOM Institute of Medicine IU International Units NAS National Academy of Sciences NLEA Nutrition Labeling and Education Act of 1990 OWG Obesity Working Group PAL Physical Activity Level RACC Reference Amount Customarily Consumed RDA Recommended Dietary Allowance RDI Reference Daily Intakes SD Standard Deviation TEE Total Energy Expenditure U.S. RDA U.S. Recommended Daily Allowance UL Tolerable Upper Intake Level EP02NO07.008 EP02NO07.009 BILLING CODE 4160-01-C Dated: October 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-5440 Filed 11-1-07; 8:45 am]

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