The Office of Government Ethics is amending pertinent sections of its executive branchwide ethics regulations on financial disclosure and standards of ethical conduct (the Standards), as codified at 5 CFR parts 2634 and 2635, in order to update them.

First, OGE is retroactively increasing, to January 1, 2002, the reporting thresholds for gifts, reimbursements and travel expenses in the OGE executive branchwide regulation at 5 CFR 2634.304 (and as illustrated in the four examples following paragraph (d) of that section) for both the public and confidential financial disclosure systems under section 102(a)(2)(A) & (B) of the Ethics in Government Act as amended, 5 U.S.C. app. § 102(a)(2)(A) & (B), as extended to the executive branch confidential reporting system by 5 CFR 2634.907(a)(3). The new reporting thresholds for gifts and travel reimbursements being retroactively incorporated in OGE's financial disclosure regulation are “more than $285” for the aggregation threshold for reporting and “$114 or less” for the de minimis exception for gifts and reimbursements which do not have to be counted towards the aggregate threshold (from the prior levels of more than $260 aggregate and $104 or less de minimis exception, respectively).

These increases are brought about by a recent General Services Administration (GSA) rulemaking raising “minimal value” under the Foreign Gifts and Decorations Act, 5 U.S.C. 7342, to “$285 or less” (from the prior level of $260 or less) for the three-year period 2002-2004, since the Ethics Act and OGE regulatory gifts/travel reimbursements reporting thresholds are tied to any such increase in foreign gifts minimal value over $250. See GSA's rulemaking as published at 67 FR 56495-56496 (September 4, 2002), revising retroactively to January 1, 2002 the foreign gifts minimal value definition as codified at 41 CFR 102-42.10.

The Office of Government Ethics will continue to adjust the gifts and travel reimbursements reporting thresholds in the future as needed in light of GSA's redefinition of “minimal value” every three years for foreign gifts purposes. See OGE's previous retroactive adjustment of those reporting thresholds as published at 65 FR 69655-69657 (November 20, 2000) that was based on GSA's prior redefinition for the period 1999-2001.

Moreover, OGE is also clarifying a couple of cross-references in examples 2 and 3 following paragraph (d) of § 2634.304.

In addition, OGE is increasing from $260 to $285 the exception ceiling for nonsponsor gifts of free attendance at widely attended gatherings under the standards of ethical conduct regulation, as codified at 5 CFR 2635.204(g)(2) (and as illustrated in several examples following paragraph (g)). This separate regulatory change is effective upon publication in the Federal Register , on October 2, 2002. As OGE noted in the preambles to the proposed and final rules on such nonsponsor gifts, that ceiling is based in part on the financial disclosure gifts reporting threshold. See 60 FR 31416 (June 15, 1995) and 61 FR 42968 (August 20, 1996). The nonsponsor gift ceiling was last raised in the November 2000 OGE rulemaking noted in the preceding paragraph above. Thus, it is reasonable now to again increase the nonsponsor gift ceiling to match the further increase in the gifts/travel reimbursements reporting thresholds. The other requirements for acceptance of such nonsponsor gifts, including an agency interest determination and expected attendance by more than 100 persons, remain unchanged.

Pursuant to 5 U.S.C. 553(b) and (d), as Director of the Office of Government Ethics, I find good cause exists for waiving the general notice of proposed rulemaking, opportunity for public comment and 30-day delay in effectiveness as to these technical updates and the correction. The notice, comment and delayed effective date provisions are being waived in part because these technical amendments concern matters of agency organization, practice and procedure. Further, it is in the public interest that correct and up-to-date information be contained in the affected sections of OGE's regulations as soon as possible. The increase in the reporting thresholds for gifts and reimbursements is based on a statutory formula and also lessens the reporting burden somewhat, and thus the effective date of that regulatory revision is being made retroactively effective to January 1, 2002, when the change became effective under the Ethics Act.

In promulgating these technical amendments, OGE has adhered to the regulatory philosophy and the applicable principles of regulation set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. These amendments have not been reviewed by the Office of Management and Budget under that Executive order, since they are not deemed “significant” thereunder.

As Director of the Office of Government Ethics, I have reviewed this final amendatory regulation in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this rulemaking will not have a significant economic impact on a substantial number of small entities.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this amendatory rulemaking does not contain information collection requirements that require the approval of the Office of Management and Budget.

The Office of Government Ethics has determined that this amendatory rulemaking is a nonmajor rule under the Congressional Review Act (5 U.S.C. chapter 8) and has submitted a report thereon to the United States Senate, House of Representatives and General Accounting Office in accordance with that law.

Prior document in this proceeding: Proposed Rule—Beef Promotion and Research Program: Amendment to Beef Promotion and Research Rules and Regulations published October 19, 2001 (66 FR 53127), with a 60 day comment period. The comment period ended December 18, 2001.

The Office of Management and Budget (OMB) has waived the review process required by Executive Order 12866 for this action.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have a retroactive effect. Section 11 of the Act provides that nothing in the Act may be construed to preempt or supersede any other program relating to beef promotion organized and operated under the laws of the United States or any State. There are no administrative proceedings that must be exhausted prior to any judicial challenge of the provisions of this rule.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Administrator of AMS has considered the economic effect of this action on small entities and has determined that this rule will not have a significant economic impact on a substantial number of small business entities. The purpose of RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly burdened.

The Department of Agriculture's (Department) National Agricultural Statistics Service estimates that in calendar year 2000 the number of cattle operations in the United States totaled approximately 1.1 million, including feedlot operations. There are also 45 QSBCs in the United States. In addition, there are 11 States with brand inspectors. The majority of these operations are considered small businesses under the criteria established by the Small Business Administration.

This final rule imposes no significant burden on the industry as it merely gives producers the opportunity to voluntarily pay the $1-per-head assessment on cattle of their own production prior to sale and to remit the assessments to the QSBC located in the producers State of residence.

The impact on QSBCs will be a redistribution of an estimated maximum of one-half million dollars of the $40 million currently retained annually in total by the 45 QSBCs. The Department estimates that up to 6 million head or 20 percent of the approximately 30 million head of steers and heifers slaughtered annually are sold for slaughter under retained ownership. The Department also estimates that assessments on up to one-sixth of the cattle (1 million head) will be paid in advance to QSBCs. If the $1 assessment were paid in advance to QSBCs on these cattle, the QSBCs' 50 percent share of up to $1 million in assessments or as much as $500,000 will be redistributed among the QSBCs.

The major cattle feeding States of Texas, Nebraska, Kansas, Colorado, and Oklahoma could reasonably be expected to account for up to 80 percent of the $500,000 in reduced revenue to QSBCs annually. These States collect an average of $19 million annually and retain one-half that amount or $9.5 million. Assuming that the revenue to each of these five States available for State directed programs was reduced by an average of $80,000, it would represent about a 1 percent decrease in the average revenue available for State directed programs in these States.

The remaining 40 QSBCs have annual State budgets that average about $500,000. An estimated net increase in annual income for these States, as a result of the advance payment of assessments, could average up to $10,000 per State representing a 2 percent increase.

Producers wishing to direct payment of assessments to the QSBC in the producers' State of residence when cattle are sent to another State for feeding under retained ownership, would complete a form that would be provided to affected parties including the QSBC, the feedlot, and the packer or the collecting person.

Copies of the completed “Certification of Producer Directed Payment of Cattle Assessments” form shall be maintained on file by the producer, the QSBC, the feedlot operator, and the purchaser of the cattle for 3 years.

We estimate the average cost of the reporting burden per respondent would be $16 annually.

We estimate the total average cost of the recordkeeping burden per recordkeeper would be $8 annually.

The Administrator of AMS has considered the economic effect of this action on small entities and has determined that this final rule will not have a significant economic impact on a substantial number of small entities.

The proposed rule that was published in the Federal Register on October 19, 2001 (66 FR 53127), invited interested persons to submit comments to the Department concerning potential effects. No comments were received regarding the RFA.

In accordance with OMB regulations (5 CFR Part 1320) which implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements contained in this rule have been approved by OMB under OMB control number 0581-0202.

Title : Certification of Producer Directed Payment of Assessments.

OMB Number : 0581-0202

Expiration Date of Approval : March 1, 2005.

Type of Request : Approval of new information collection.

Abstract : The Act provides for a program of promotion, research, consumer information, and industry information funded by assessments paid by beef producers each time cattle are sold and by importers of cattle and beef products upon importation.

Assessments on imported cattle and beef products are collected by the U.S. Customs Service at the rate of $1 per head or the live animal equivalent of beef and beef products. An assessment of $1 per head is due from the producer each time a producer sells cattle in the United States. The assessment is to be collected by the purchaser or other “collecting person” as provided in the rules and regulations published in the Federal Register on February 26, 1988 (53 FR 5749). The producer assessments are then remitted to QSBCs in 45 States and to the Board in the remaining States. QSBCs retain up to one-half of the $1 assessment for use in State directed programs and forward the other half to the Board. Currently, QSBCs in the traditional cattle feeding States ( e.g. , Texas, Kansas, Nebraska, Oklahoma, and Colorado) collect and retain assessments on cattle sold that are owned by producers residing in other States. This benefits QSBCs in the States that have large numbers of cattle in feedlots owned by producers residing in other States. Some producers retain ownership of cattle and transport them to one of the cattle feeding States. To provide producers with more flexibility and to provide the opportunity for a more equitable distribution of assessment funds to States based on cattle ownership, the final “Certification of Producer Directed Payment of Cattle Assessments” form would be made available for use by producers who want the QSBC located in their States of residence to receive assessment funds rather than the QSBC in the State where the cattle are fed.

1. Certification of Producer Directed Payment of Assessments.

Estimate of Burden: The public reporting burden for this collection of information is estimated to average .20 hour per response.

Respondents: Producers wishing to direct payment of assessments to the QSBC in the producers' State of residence when cattle are sent to another State for feeding under retained ownership would use the form.

Estimated Number of Respondents: 1,000.

Estimated Number of Responses per Respondent: 4.

Estimated Total Annual Burden on Respondents: 800 hours.

Total cost: $16,000.

2. Maintenance of records: 3 years.

Estimate of Burden: The public recordkeeping burden for keeping this document is estimated to average .10 hour per recordkeeper.

Recordkeepers: Producers, QSBCs, feedlot operators, and purchasers.

Estimated Number of Recordkeepers: 1,260.

Estimated Total Recordkeeping Hours: 504 hours.

Estimated Total Cost: $10,080.

The total average cost of the estimated annual reporting burden per respondent would be: $16.00.

The total average cost of the recordkeeping burden per recordkeeper would be: $8.00.

The Act authorizes the establishment of a national beef promotion and research program. The final Order establishing a beef promotion and research program was published in the Federal Register on July 18, 1986, (51 FR 21632) and assessments began on October 1, 1986. The program is administered by the Board which is composed of 110 domestic cattle producers and importers. The program is funded by a $1-per-head assessment on producer marketings of cattle in the United States and an equivalent amount on imported cattle, beef, and beef products. In 45 States, QSBCs receive the $1-per-head of cattle assessment remitted under the program and retain up to half of the $1 for State-directed programs and remit the remainder to the Board. The Board receives all import assessments and all producer assessments in the five States with relatively small cattle numbers that do not have QSBCs. In 2000, the 45 QSBCs received a total of about $80 million in assessments. QSBCs retained about $40 million and remitted approximately $40 million to the Board.

The domestic assessment, due each time cattle are sold by a producer, is collected by the buyer or “collecting person” and remitted to the Board or QSBC. The term “producer” is defined as follows: “any person who owns or acquires ownership of cattle; provided, however, that a person shall not be considered a producer within the meaning of this subpart if (a) the person's only share in the proceeds of a sale of cattle or beef is a sales commission, handling fee, or other service fee; or (b) the person (1) acquired ownership of cattle to facilitate the transfer of ownership of such cattle from the seller to a third-party, (2) resold such cattle no later than 10 days from the date on which the person acquired ownership, and (3) certified, as required by regulations prescribed by the Board and approved by the Secretary, that the requirements of this provision have been satisfied.”

When cattle are sold within 10 days of purchase by a person who is not a producer under the above definition, the collecting person is not required to collect the $1 assessment from the person (seller), if the seller provides the collecting person with a Statement of Certification of Non-Producer Status on a form approved by the Board and the Secretary. The person claiming non-producer status must submit to the collecting person a Statement of Certification of Non-Producer Status “at the time of sale” in lieu of paying the assessment.

In a similar fashion, this modification to the regulations to permit producer-directed payment of assessments will result in the collecting person, at the time of sale, collecting a document certifying that the assessment had been paid in advance by the producer.

The Department believes that this producer-directed payment option will be used by producers of a relatively small share of all cattle sold. This rule will apply only to cattle of a producer's own production transported to another State under retained ownership for feeding prior to sale as slaughter cattle. Utilizing this option would permit a producer who retains ownership of cattle to ensure that the QSBC located in the State where the producer resides receives the $1 checkoff rather than the QSBC in the State in which the cattle are located when sold. This final rule could increase checkoff revenue for many QSBCs such as those located in the southeastern United States that currently do not receive revenue from cattle owned and sold by producers residing in the southeastern States who use feedlots in States such as Texas, Kansas, Nebraska, Oklahoma, and Colorado to finish cattle before selling the cattle to packers.

Since States retain up to one-half of the $1-per-head checkoff for use in State directed programs, providing producers with the flexibility and the opportunity to direct payment of the assessment to their home State likely would increase revenue in many States such as Florida, Georgia, Alabama, and Mississippi with limited feedlot capacity.

On October 19, 2001, the Department published in the Federal Register (66 FR 53127) for comment a proposed rule to amend the Rules and Regulations established under the Act. The proposed rule provided the opportunity for a producer to pay the $1-per-head assessment to the QSBC located in the producer's State of residence prior to sale, subject to certain conditions.

The proposed rule was published with a request for comments to be submitted by December 18, 2001. The Department received comments from 47 national and State beef and dairy cattle organizations, and brand inspectors, as well as from cattle producers. Comments from 44 commenters were filed on time. Eleven commenters supported the proposed rule while four commenters proposed modifications and requested clarifications to it. Twenty-nine commenters opposed the proposed rule. Three comments were submitted after the comment period ended. The late comments, however, supported the rule as proposed.

The comments are discussed below, together with a description of the changes made by the Department in this final rule. In general, persons and organizations in States that may see an increase in assessments supported the proposed rule, while persons and organizations in the primary cattle feeding States that may see a reduction in assessments did not support the proposed rule.

Three commenters suggested producers, QSBCs, the Board, the feedlot operator, and the purchaser of the cattle should maintain copies of the Certification of Producers Direct Payment of Cattle Assessments forms on file for 3 years rather than 2 years. The standard procedure currently in place for random compliance audits of remitters is 3 years. The Department believes that this comment has merit, and this change is reflected in § 1260.311(f)(4) by removing 2 years and inserting 3 years.

One commenter asserted that the QSBC which receives the additional checkoff funds must be responsible for compliance. Currently, QSBCs are responsible for collecting and remitting the assessment to the Board and ensuring that those persons subject to the assessment remit them. In States where there is no QSBC, the Board is responsible for compliance. Accordingly, the Department is not making any changes in response to this comment.

The same commenter suggested that the term Board could be omitted from § 1260.311(f)(1), as only the QSBC located in the State where the producer resides would apply. The commenter noted that producers in the five States without a QSBC will be unable to use this option as their dollar already is currently directed to the Board. The Department believes that this comment has merit and therefore the term Board is removed from § 1260.311(f)(1) in this final rule.

Five commenters stated that the regulations must specify what “cattle of a producer's own production” are in order to ensure this includes only offspring from a producer's own cow herd that have been continuously and exclusively under his or her ownership, and are being sent to feedlots with the intent of continuously owning the cattle through the entire feeding phase. The Department believes that this comment has merit and additional clarification regarding the meaning of “cattle of a producer's own production” is reflected in new § 1260.311(f)(iii) of this final rule.

Three commenters asserted that producers must list the number of their cow herds on the certificate as a method to cross check that the cattle transported to the feedyard qualify as retained ownership cattle. The Department believes that this additional requirement would not have any impact on compliance activities. The current compliance practices in the industry and the proposed certification process are sufficient to ensure compliance with the provisions of the Act, the Beef Promotion and Research Order (Order), and this final rule.

Two commenters suggested that the regulation should apply only to true retained ownership cattle. Since cattle sold through auctions, dealer/order buyers, and country sales are not applicable, the commenters believe these references should be removed from the table in § 1260.311(c). While the table in § 1260.311(c) is being updated as part of this final rule, it does not directly apply to the producer payment option of this final rule. It specifies the party responsible for collecting and remitting assessments in designated States. Accordingly, the Department is not making any changes in response to these comments.

Another commenter stated that assessments should be collected on cattle sold within the first 30 days of movement and the dollars returned to the State of Origin under the current rules. The Department believes that the option provided for in this rule is flexible and cost effective for producers. Under § 1260.311(f)(1)(ii) of the rule producers can pay the assessment either before or at the time the cattle are transported. Therefore, we are not making any changes to the rule in response to this comment.

Three commenters stated that the regulations should address death loss on cattle that are prepaid in the State of Origin. The commenters suggested that the proposal should specify that the producer will not be given a credit of their dollar for cattle that have died before they are shipped to the ultimate purchaser of the cattle. The Department believes that this comment has merit. Because of the low mortality rates and the costs associated with administrative matters involving investigation of animal death and producer, QSBC and Board notification, the costs associated with producer credits would be substantial, far in excess of the $1-per-head assessment paid by the producer. Therefore, we are adding a new paragraph 5 to § 1260.311(f) of this final rule to prohibit credits of assessments for those cattle lost because of death.

Three commenters asserted that many feedlots and retained ownership programs involve sorting and co-mingling of cattle from various owners into numerous different pens and lots and then sold to the packer at different times. Consequently, if the assessment is prepaid, the documentation on those cattle could be confusing since they will not be processed in the same lot. The Department believes the feedlot should not be required to complete a new form. Feedlots may note on the existing form that the specific cattle marketed have been prepaid in order to facilitate their own recordkeeping. Accordingly, we are not making any changes in response to this comment.

One commenter expressed concern that some cattle may be placed on feed with the producer having the intention of retaining ownership through the entire feeding cycle. However, during the feeding cycle, the producer may decide to sell a partial interest in the cattle within the feedyard. The purpose of this rule is to provide producers the opportunity to voluntarily pay the $1-per-head assessment to the QSBC on cattle transported to a feedyard under retained ownership. This rule does not provide producers with an opportunity for a credit. If a producer transfers any interest in the cattle prior to their sale to a purchaser, the cattle are no longer covered under the provisions of this rule. Consequently, an additional assessment is due as a result of the new owner transfer, even if the transfer of ownership is only partial.

Four commenters asserted that the QSBC receiving the checkoff should be required to send a new verification form to the feedlot to notify it that the checkoff has been received. The Department believes that any additional certification of producer payment by QSBCs would be unnecessary and burdensome. As noted previously, the Department believes that the current certification is sufficient to ensure compliance with the provisions of this final rule. Therefore, we are not making any changes in response to this comment.

One commenter stated that the assessments should be paid at the time of transport. Under § 1260.311(f)(1)(ii) of the rule producers can pay the assessment either before or at the time the cattle are transported.

One commenter suggested that the packer should retain a copy of the certificate, not the feedlot, because the packer, as the purchaser, is responsible for collecting the checkoff for slaughter cattle. The commenter believes that this would provide a simple and streamlined procedure for compliance and audit. Section 1260.311(f)(4) requires that the certification form be sent to all parties involved, including packers when they act as purchasers.

One commenter suggested that the producer should be responsible for ensuring the paperwork accompanies the cattle throughout the production process. Section 1260.311(f)(1)(i) requires that the certification be completed by the producer and sent to the feedlot operator. This certification will accompany the cattle when they are sold.

One commenter believes that the final regulation will create compliance problems and will be difficult to correctly monitor and may cause double assessments, incorrect assessments, or no assessments collected. The Department believes that because of the anticipated small number of producers that will prepay the assessment, any compliance problems that may arise will be manageable. In addition, the rule provides that the required certification must accompany the cattle through the entire process, thereby minimizing any potential compliance problems. Further, if the certification does not accompany the cattle, those cattle would be assessed the $1-per-head checkoff in accordance with the Act and the Order.

Twenty-eight commenters asserted that the proposal would increase paperwork required to accompany cattle transported to other States. The Department does not anticipate a significant increase in administrative costs and paperwork for those States primarily affected by this final rule because of the anticipated small number of producers who will prepay the assessment.

Twenty-seven commenters asserted that the top five cattle producing States would have to deal with this new procedure more frequently than other States. While the Department recognizes that the larger cattle producing States will likely be more affected, we believe that because of the anticipated small number of producers who will prepay the assessment, any additional burden will be small.

Twenty-nine commenters asserted that in the hosting State, livestock markets, packing plants, feedlots, etc., will need to implement a new accounting procedure to exempt the checkoff from this type of transaction. The Department believes that the certification form completed by the producer should not require persons to implement a new accounting system since the cattle will have already been assessed.

Twenty-nine commenters asserted that in the hosting State, double assessments may increase if cattle arrive without the new certification. If the certification does not accompany the cattle, those cattle would be assessed the $1-per-head checkoff in accordance with the Act and the Order. It is the responsibility of the producer to ensure that the certification form accompanies the cattle when they are transported to the feedlot.

Twenty-nine commenters asserted that if out of State cattle arrive without the certification, brand inspectors will, by law, collect the assessment. As previously noted, if the certification form does not accompany the cattle, the brand inspector will collect the assessment in accordance with the Act, the Order, and the Rules and Regulations.

Twenty-one commenters asserted that if out of State cattle arrive without the prepaid document, QSBCs will have increased workload due to processing the double assessments. The Department does not anticipate a significant increase in workload or paperwork burden because of the anticipated small number of producers who will prepay the assessment. If cattle arrive without the required certification, the cattle will be assessed in accordance with the Act, the Order, and the Rules and Regulations.

One commenter asserted that the proposal would divert a significant amount of funds away from promotion into record and paperwork management. The Department does not expect that there will be a significant increase in workload or paperwork burden because of the anticipated small number of producers who will prepay the assessment.

Additional Changes. We are making nonsubstantiative changes to § 1260.311(f) for the purpose of clarity. In addition, the Board recommended that the chart under § 1260.311(c) be corrected and updated to reflect the current collection and remittance procedures in States where brand inspectors are responsible for collecting and remitting assessment. Based upon our review of the Board's comment, we are making changes to the chart in this rule as follows:

Add the State of Nevada and change collecting person (CP) to brand inspector (B) in Idaho for transactions which occur at auction markets and slaughter/packer. The changes reflect those additions and changes to the chart under § 1260.311(c).

Pursuant to 5 U.S.C. 553, it is found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register . An effective date of October 1, 2002, will allow producers to take advantage of this action in time for fall cattle marketings. This rule permits producers who retain ownership of cattle that are shipped to another State for feeding to pay the $1 checkoff to the QSBC located in the State where the producer resides rather than the QSBC in the State in which the cattle are located when sold.

Section 301(c) of the FMIA (21 U.S.C. 661(c)) and section 5(c) of the PPIA (21 U.S.C. 454(c)) authorize the Secretary of Agriculture (Secretary) to designate a State as one in which the provisions of Titles I and IV of the FMIA and sections 1-4, 6-11, and 12-22 of the PPIA will apply to operations and transactions wholly within the State after the Secretary has determined that requirements at least equal to those imposed under the Acts have not been developed and effectively enforced by the State.

At different times in the past, the Secretary designated the State of Maine under section 301(c) of the FMIA and section 5(c) of the PPIA as a State in which the Federal Government is responsible for providing meat and poultry products inspection at eligible establishments and for otherwise enforcing the applicable provisions of the FMIA and the PPIA with regard to intrastate activities in the State. These designations were undertaken by the Secretary when it was determined that the State of Maine was not in a position to enforce requirements that are at least equal to the requirements of FMIA and PPIA enforced by the Federal Government.

On January 2, 1971, the Federal Government assumed the responsibility of administering the authorities provided for under sections 11(b) and (c) of the PPIA (21 U.S.C. 460(b) and (c)). On May 12, 1980, the Federal Government assumed the responsibility of administering the authorities provided for under sections 202 and 203 of the FMIA (21 U.S.C. 642 and 643).

The Director of Agriculture of the State of Maine has advised FSIS that on October 17, 2002, the State of Maine will publish regulations declaring that it will administer a State meat and poultry products inspection program that includes requirements at least equal to those imposed under the Federal meat and poultry products inspection program.

Section 301(c) of the FMIA and section 5(c) of the PPIA provide that whenever the Secretary of Agriculture determines that any designated State has developed and will enforce State meat and poultry products inspection requirements at least equal to those imposed by the Federal Government under the FMIA and the PPIA with regard to intrastate operations and transactions, the Secretary will terminate the designation of such State. The Secretary has determined that the State of Maine has developed, and will enforce, such a State meat and poultry products inspection program in accordance with the applicable provisions of the FMIA and the PPIA.

Establishments have the option to apply for Federal or State inspection. However, product produced under State inspection is limited to distribution in intrastate commerce.

This final rule is issued in conformance with Executive Order 12886 and has been determined not to be a major rule. It will not result in an annual effect on the economy of $100 million or more and will not adversely affect the economy or any segment of the economy. Because this final rule is not a significant rule under Executive Order 12866, it has not undergone review by the Office of Management and Budget.

The FSIS Administrator has determined that this action will not have a significant economic impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (Pub. L. 96-354; 6 U.S.C. 601). As stated above, the State of Maine is assuming a responsibility, previously limited to the Federal Government, of administering a meat and poultry products inspection program for intrastate operations and transactions.

FSIS has considered the potential civil rights impact of this final rule on minorities, women, and persons with disabilities. Public involvement in all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this rulemaking, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through the Listserv and web page, FSIS is able to provide information to a much broader, more diverse audience.

For more information contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv) go to the “Constituent Update” page on the FSIS web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the “Subscribe to the Constituent Update Listserv” link, then fill out and submit the form.

The Truth in Lending Act (TILA; 15 U.S.C. 1601 - 1666j) requires creditors to disclose credit terms and the cost of consumer credit as an annual percentage rate. The act requires additional disclosures for loans secured by a consumer's home, and permits consumers to cancel certain transactions that involve their principal dwelling. TILA is implemented by the Board's Regulation Z (12 CFR part 226). The Board's official staff commentary (12 CFR part 226 (Supp. I)) interprets the regulation, and provides guidance to creditors in applying the regulation to specific transactions.

In 1995, the Board published amendments to Regulation Z implementing HOEPA, contained in the Riegle Community Development and Regulatory Improvement Act of 1994, Pub. L. 103-325, 108 Stat. 2160 (60 FR 15463). These amendments are contained in § 226.32 and 226.34 of the regulation and impose substantive limitations and additional disclosure requirements on certain closed-end mortgage loans bearing rates or fees above a certain percentage or amount. As enacted, the statute requires creditors to comply with the HOEPA rules if the total points and fees payable by the consumer at or before loan consummation exceed the greater of $400 or 8 percent of the total loan amount. TILA and Regulation Z provide that the $400 figure shall be adjusted annually on January 1 by the annual percentage change in the Consumer Price Index (CPI) that was reported on the preceding June 1. (15 U.S.C. 1602(aa)(3) and 12 CFR 226.32(a)(1)(ii)). The Board adjusted the $400 amount to $480 for the year 2002.

The Bureau of Labor Statistics publishes consumer-based indices monthly, but does not “report” a CPI change on June 1; adjustments are reported in the middle of each month. The Board uses the CPI-U index, which is based on all urban consumers and represents approximately 80 percent of the U.S. population, as the index for adjusting the $400 dollar figure. The adjustment to the CPI-U index reported by the Bureau of Labor Statistics on May 15, 2002, was the CPI-U index “in effect” on June 1, and reflects the percentage increase from April 2001 to April 2002. The adjustment to the $400 figure below reflects a 1.64 percent increase in the CPI-U index for this period and is rounded to whole dollars for ease of compliance.

For the reasons set forth in the preamble, for purposes of determining whether a mortgage transaction is covered by 12 CFR 226.32 (based on the total points and fees payable by the consumer at or before loan consummation), a loan is covered if the points and fees exceed the greater of $488 or 8 percent of the total loan amount, effective January 1, 2003. Comment 32(a)(1)(ii)-2, which lists the adjustments for each year, is amended to reflect the dollar adjustment for 2003. Because the timing and method of the adjustment is set by statute, the Board finds that notice and public comment on the change are unnecessary.

The Board certifies that this amendment will not have a substantial effect on regulated entities because the only change is to raise the threshold for transactions requiring HOEPA disclosures.

Advertising, Federal Reserve System, Mortgages, Reporting and recordkeeping requirements, Truth in lending.

By order of the Board of Governors of the Federal Reserve System, acting through the Director of the Division of Consumer and Community Affairs under delegated authority, September 26, 2002.

A proposal to amend 14 CFR part 39 to include an AD for ECF Model AS332C, L, L1, and L2; AS350B, BA, B1, B2, B3, and D; AS355E, F, F1, F2, and N; AS-365N2; AS 365 N3; SA330F, G, and J; SA-360C; SA-365C, C1, and C2; SA.316B and C; and SA.319B helicopters was published in the Federal Register on May 16, 2002 (67 FR 34880). That action proposed to require, before the next refueling of an installed tank or before the first fueling after installing a tank, a one-time measurement of the electrical resistance between the tank electrostatic ground connector and the tank filler neck to determine if the electrical resistance has a value more than 1.5 milliohms. If the value of the electrical resistance is more than 1.5 milliohms, the proposal would prohibit refueling the tank.

The Direction Generale de L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on ECF Model AS332C, L, L1, and L2; AS350B, BA, B1, B2, B3, and D; AS355E, F, F1, F2, and N; AS-365N2; AS 365 N3; SA330F, G, and J; SA-360C; SA-365C, C1, and C2; SA.316B and C; and SA.319B helicopters. The DGAC advises of the absence on several tanks of an electric bond between the electrostatic ground connector and its support. During refueling of a tank, the inadequate electrical bonding could generate an electric arc between the refueling nozzle of the tanker and the tank and could cause the tank to explode.

ECF has issued Telex No. 000112 dated June 6, 2000, which specifies a one-time measurement of the electrical resistance between the tank electrostatic ground connector and the tank filler neck to determine if the value is more than 1.5 milliohms. If the value of the electrical resistance of the electrical bonding is more than 1.5 milliohms, the service telex specifies a secondary procedure for measuring the electrical resistance. If the value of the electrical resistance is more than 1.5 milliohms after the secondary measurement, the tank is unusable and the telex specifies a repair. The DGAC classified this telex as mandatory and issued AD 2000-302(A), dated July 12, 2000, to ensure the continued airworthiness of these helicopters in France.

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

We estimate that 736 helicopters of U.S. registry will be affected by this AD. Measuring the electrical resistance between the tank electrostatic ground connector and the tank filler neck will take approximately 1/2 work hour per helicopter to accomplish, and the average labor rate is $60 per work hour. Based on these figures, the total cost impact of this AD on U.S. operators is estimated to be $22,080 for the first refueling of all installed tanks.

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

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

A proposal to amend 14 CFR part 39 to include an AD for Model HH-1K, TH-1F, TH-1L, UH-1A, UH-1B, UH-1E, UH-1F, UH-1H, UH-1L, and UH-1P; and Southwest Florida Aviation Model SW204, SW204HP, SW205, and SW205A-1 helicopters was published in the Federal Register on April 10, 2002 (67 FR 17305). That action proposed updating the product identification, extending the application of the AD to other models, continuing the existing retirement time for certain TT straps, and adding the TT strap part numbers to the applicability for the specified military surplus helicopters.

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

One commenter states that Model AH-1 series helicopter should be added to the applicability section of the AD, because Model AH-1 series helicopters are currently being operated in experimental and restricted categories, and have identical TT straps as the HH-1K and UH-1L helicopter that are included in the applicability of the AD. The commenter also states that the FAA should evaluate TT strap, part number 204-310-101-101, because “this current production TT strap is life-limited * * * to 1,200 hours of operation or a calendar time of two years” when installed on standard category type certificated Bell products.

The FAA concurs, however the intent of AD's, Docket Numbers 2001-SW-41-AD and 2001-SW-42-AD, was to update the model applicability and type certificate holders of AD 80-17-09 for the Model UH-1 military surplus helicopters. If we were to add the additional helicopter models or part numbers as proposed by the commenter, we would need to issue a Supplemental Notice of Proposed Rulemaking. To avoid further delay in the effectivity of the published proposals, we are issuing this final rule as proposed. The comments suggesting an expansion of these AD provisions to additional model helicopters and TT strap part numbers will be further evaluated and may be incorporated into a subsequent AD.

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

The FAA estimates that 75 helicopters of U.S. registry will be affected by this AD, that it will take approximately 8 work hours per helicopter to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $10,484 per helicopter. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $822,300.

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

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

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

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

In addition, we conducted extensive reviews of the evidence on the 10 substance-disease relationships listed in the 1990 amendments, including dietary fiber and reduced risk of cardiovascular disease (CVD). As a result of our review, we have authorized claims that relate to 8 of these 10 relationships.

During 1990 to 1993, we conducted an extensive review of the relationship between dietary fiber and CVD. We examined the then current state of scientific opinion regarding the role of total dietary fiber in general, without focusing on any particular dietary fiber. Although we denied the use of a health claim relating total dietary fiber to reduced risk of CVD (58 FR 2552, January 6, 1993), we authorized a health claim relating fruits, vegetables, and grain products that contain dietary fiber, particularly soluble dietary fiber, to reduced risk of CHD, one of the more common serious forms of CVD (58 FR 2552, January 6, 1993).

We concluded that, based on the totality of publicly available scientific evidence, there was significant scientific agreement that the evidence supported an association between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products (i.e., foods that are low in saturated fat and cholesterol and that are good sources of dietary fiber) and reduced risk of coronary heart disease (58 FR 2552 at 2572). We therefore authorized a health claim in part 101 (21 CFR part 101) in § 101.77 on the association between diets low in saturated fat and cholesterol and high in vegetables, fruit, and grain products that contain soluble fiber and a reduced risk of CHD.

In the 1993 dietary fiber and CVD final rule, in response to a comment regarding the apparent hypocholesterolemic properties of specific food fibers, e.g., oat bran, we agreed that the effectiveness of naturally occurring fibers in foods may be documented for specific food products (e.g., oat bran meeting specified parameters) (58 FR 2552 at 2567). We further stated that if a manufacturer could document, through appropriate studies, that dietary consumption of the soluble fiber in its particular food has the effect of lowering low density lipoprotein (LDL)-cholesterol, and has no adverse effects on other heart disease risk factors (e.g., high density lipoprotein (HDL)-cholesterol), it should petition for a health claim for its particular product (58 FR 2552 at 2567).

We subsequently received a petition for, and authorized, a health claim on the relationship between soluble fiber from whole oats and reduced risk of CHD (the soluble fiber from whole oats final rule) (62 FR 3584, January 23, 1997; modified at 62 FR 15343, March 31, 1997). We initially proposed to authorize a health claim on the association between oat bran and oatmeal and reduced risk of CHD (the oats proposed rule) (61 FR 296, January 4, 1996). However, we concluded in the final rule that the type of soluble fiber found in whole oats, i.e., beta-glucan soluble fiber, is the component primarily responsible for the hypocholesterolemic effects associated with consumption of whole oat foods as part of a diet that is low in saturated fat and cholesterol (62 FR 3584 at 3585). We reached this conclusion based on evidence that there is a dose response between the level of beta-glucan soluble fiber from whole oats and the level of reduction in blood total- and LDL-cholesterol, and that intakes of beta-glucan soluble fiber at or above 3 gram (g) per day were more effective in lowering serum lipids than lower intake levels (62 FR 3584 at 3585). As such, we concluded that, rather than oat bran and rolled oats, the appropriate substance for the subject of the authorized claim is beta-glucan soluble fiber from whole oats. We further determined that the relationship is scientifically valid in that there is significant scientific agreement, based on the totality of publicly available evidence, that beta-glucan soluble fiber from whole oats, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (62 FR 3584 at 3598).

Several comments to the oats proposed rule suggested that products containing whole oat flour made from 100 percent oat groats also should be eligible to bear the health claim (62 FR 3584 at 3585). The reasons given included: (1) Whole oat flour contains beta-glucan soluble fiber as does oat bran and rolled oats; (2) whole oat flour is derived from the same starting material as rolled oats (i.e., whole oat groats) and, other than the smaller particle size of whole oat flour, whole oat flour possesses a chemical and physical composition virtually identical to that of rolled oats; (3) intestinal content viscosity data from rodent studies demonstrate that whole oat flour beta-glucan soluble fiber retains viscosity similar to that of the beta-glucan soluble fiber from oat bran and rolled oats during processing and digestion; and (4) data from one human clinical study and several experimental animal studies demonstrate that whole oat flour has similar effects on blood cholesterol levels as oat bran and rolled oats (62 FR 3584 at 3585).

We were persuaded that the clinical data showing the positive effects of consuming whole oat flour foods on blood cholesterol, and comments showing compositional similarities between whole oat flour and rolled oats, provided sufficient evidence for us to conclude that whole oat flour has the same effects relative to reduced risk of CHD as do oat bran and rolled oats (62 FR 3584 at 3586). Further, this conclusion was corroborated by evidence from the rodent intestinal contents studies. These studies demonstrate that the beta-glucan soluble fiber from whole oat flour retains the same level of viscosity in the rodent digestive tract as does that from rolled oats (62 FR 3584 at 3586). The whole oats final rule concluded that beta-glucan soluble fiber was the appropriate substance for the subject of the health claim, and that the three eligible sources of this substance were oat bran, rolled oats, and whole oat flour.

In the soluble fiber from whole oats final rule, we acknowledged the likelihood that consumption of other sources of beta-glucan soluble fiber, as well as other sources and types of soluble fibers, will affect blood lipid levels, and thus, the risk of heart disease (62 FR 3584 at 3587). At that time, FDA considered structuring the final rule as an umbrella regulation authorizing the use of a claim for “soluble fiber from certain foods” and risk of CHD. Such action would have allowed flexibility in expanding the claim to other specific food sources of soluble fiber when consumption of those foods has been demonstrated to help reduce the risk of heart disease. However, the agency concluded that it was premature to do so inasmuch as FDA had not reviewed the totality of evidence on other, nonwhole oat sources of soluble fiber (62 FR 3584 at 3588). In 1998, FDA announced that, in response to a health claim petition and on the totality of the available scientific evidence, it had concluded that soluble fiber from psyllium seed husk, similar to beta-glucan soluble fiber from whole oats, may reduce the risk of CHD by lowering blood cholesterol levels (63 FR 8103, February 18, 1998). In that action, FDA broadened § 101.81 to include soluble fiber from psyllium seed husk, and also modified the heading in § 101.81 from, “* * * Soluble fiber from whole oats and risk of coronary heart disease” to “* * * Soluble fiber from certain foods and risk of coronary heart disease (CHD).”

The Quaker Oats Co. and Rhodia, Inc. (the petitioners), jointly submitted a health claim petition to FDA on April 21, 2001, under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)). The petition requested that the agency amend the “Soluble fiber from certain foods and coronary heart disease health claim” at § 101.81 to include a fourth source of beta-glucan soluble fiber eligible for the claim. The petitioners requested that this amendment be made “* * * with specific reference to the Quaker-Rhodia group Oatrim, known as Oatrim (BETATRIM).” The petition notes that “[n]ot all Oatrims have been tested for cholesterol-lowering efficacy; hence we are limiting our petition to the subgroup Oatrim (BETATRIM), Oatrims with demonstrated cholesterol-lowering efficacy” (Ref. 1). FDA filed the petition for comprehensive review in accordance with section 403(r)(4) of the act on July 20, 2001 (Ref. 2).

The petitioners' description of the substance that is the subject of the health claim is broader than what the available evidence supports. We have determined that the evidence supports specifying the substance that is the subject of the claim as the beta-glucan-containing soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan soluble fiber content up to 10 percent (dwb) and not less than that of the starting material (dwb), also known as oatrim (Ref. 3). This oatrim substance is produced by the methods described by Inglett and Newman, 1994 (Ref. 3). In brief, the manufacturing method consists of first preparing a 10 to 40 percent slurry of a milled oat product (specifically, oat bran or whole oat flour) in water containing 25 to 50 parts per million calcium to stabilize the subsequently added alpha-amylase enzyme, and with a pH adjusted between 5.5 and 7.5. Then the starch of the oat product is liquefied by adding a thermostable alpha-amylase enzyme and processing at a temperature (70 to 100 °C) and time (10 to 60 minutes) determined by the desired product properties. After completion of the enzymatic hydrolysis of the starch, the enzyme is inactivated and the water-soluble fraction consisting of soluble oat fiber and maltooligosaccharides is separated from the water-insoluble residue by centrifugation (Ref. 3). For brevity, we will refer to this substance as oatrim, which is the substance that is the subject of the claim in this interim final rule. Oatrim was developed by George Inglett, Agriculture Research Service, U.S. Department of Agriculture (USDA) (Ref. 3).

The petition describes the substance that is the subject of the health claim to be “oatrim (BETATRIM),” a source of “oat beta-glucan soluble fiber and oat starch obtained by enzymatic and/or acid-base hydrolysis of whole oat flour or oat bran.” Thus, the substance as described by the petition includes, in addition to solubilized beta-glucan-containing oat products produced by the enzymatic hydrolysis method, solubilized beta-glucan-containing oat products produced by an acid-base chemical hydrolysis method. In addition, BETATRIM is the petitioners' brand-name for a group of beta-glucan-containing food ingredients. The petitioners have noted that the products they include under their brand-name are “oatrims” processed by either alpha-amylase enzymes or by acid/base hydrolysis, and having a beta-glucan soluble fiber content ranging between 4 and 25 percent. However, as discussed later in this preamble, we are limiting the substance that is the subject of the health claim to the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan soluble fiber content of up to 10 percent (dwb) and not less than that of the starting material (dwb).

CHD continues to be a disease that has a large impact on mortality and morbidity in the general adult U.S. population. As explained in the existing beta-glucan soluble fiber from whole oats health claim (§ 101.81), FDA recognizes the CHD risk reduction benefit resulting from effects on blood total and LDL-cholesterol associated with certain foods that are sources of soluble dietary fiber. While age-adjusted CHD mortality rates in the United States had been steadily decreasing since approximately 1960, recent evidence has suggested that the decline in CHD mortality has slowed (Ref. 4). CVD accounts for more than 900,000 U.S. deaths annually and has been recognized as the dominant cause of death in the United States for at least the last 50 years (Ref. 4). Based on these facts, FDA concludes that, as required in § 101.14(b)(1), CHD is a disease for which the U.S. population is at risk.

Oatrim is to be consumed at “other than decreased dietary levels,” and contributes nutritive value when used at a level providing at least 0.75 g beta-glucan soluble fiber per serving, in a variety of food products. The term “nutritive value” is defined in § 101.14(a)(3) as “value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.” The petitioners provided three examples of food categories (bars, beverages and beverage mixes) in which oatrim could be used as an ingredient at a level providing 0.75 g beta-glucan soluble fiber per serving, the level necessary to justify the claim (Ref. 1, Table 3: Some Uses of Oatrim (BETATRIM)). At this level, oatrim provides nutritive value because it provides a consequential source of calories and soluble fiber. Therefore, the preliminary requirement of § 101.14(b)(3)(i) is satisfied.

The petition states that oatrim has been used as a food ingredient in a variety of food products. The petition also notes that oatrim-containing foods including cereals, frozen foods, dairy products, beverages, baked products, mixes, and meat and poultry products have been consumed by the public for a number of years. The agency therefore is satisfied that the substance is a food, food ingredient, or a component of a food ingredient.

The petitioners assert that the basis for safe and lawful use of oatrim in food as a food ingredient, at levels necessary to justify the health claim, is that such food use of oatrim is GRAS (generally recognized as safe) by GRAS self-determination. In addition, the petitioners declare that BETATRIM derived from either oat bran or whole oat flour, and subjected to hydrolysis by treatment with safe and suitable food grade enzymes and/or GRAS listed food grade acids or bases, is GRAS through scientific procedures for use as a fat substitute in a variety of foods. The petitioners also declare that over the last several years, Quaker Oats and Rhodia have sold BETATRIM with a concentration of 4 to 6 percent beta-glucan soluble fiber, which has been incorporated by food manufacturers into a number of foods, including low-fat pancakes, muffins, biscuits, a low-fat, high-fiber nutrition bar, and fat-free frankfurters (Ref. 1). The petitioners submitted documentation of a 1992 GRAS self-determination for oatrim by The Quaker Oats Co. (Ref. 1, Appendix 3), a 1991 GRAS self-determination for oatrim by ConAgra (Ref. 1, Appendix 4), and an individual opinion regarding the GRAS status of purified forms of beta-glucan soluble fiber from oats (Ref. 1, Appendix 5) as evidence that oatrim meets the safe and lawful requirement.

The 1992 Quaker Oats Co. documentation of GRAS self-determination (Ref. 1, Appendix 3) characterized oatrim as the water soluble, partially enzymatically hydrolyzed starch fraction of whole oat flour. Oatrim was described as representing about 60 percent of the whole oat flour starting material, and containing 4 to 6 percent beta-glucan soluble fiber and 6.9 percent total dietary fiber. The Quaker Oats Co. determined that the use of oatrim as a fat replacer in fresh ground and processed meats and poultry products, salad dressings, baked goods, baking mixes, processed cheese, yogurt, ice cream and frozen desserts, snack foods, vegetable oil spreads, icings and frostings, frozen entrees, and confections was GRAS. The basis of the safety determination was the similarity of oatrim to oat starch and maltodextrin, two food ingredients that are generally recognized as safe for food use.

The 1991 ConAgra Specialty Grain Products Co. documentation of GRAS self-determination (Ref. 1, Appendix 4) characterized the processing of oatrim as “oat flour or oat bran that is pre-gelatinized and enzyme thinned, by alpha-amylase, to facilitate separation and recovery of the soluble fraction.” It noted that the basis of the safety determination was the similarity of oatrim to other existing cereal adjuncts, such as pre-cooked flours, pre-cooked bran, and starches.

The petitioners also submitted a letter from Joseph F. Borzelleca, Consultative Services, Medical College of Virginia & Toxicology and Pharmacology, Inc. (Ref. 1, Appendix 5), stating his opinion that beta-glucan soluble fiber extracted from oat bran or oat flour through enzymatic or by acid/base hydrolysis and containing a maximum concentration of beta-glucan of 25 percent is GRAS when used as a water-binder, humectant, or texture modifier. However, the substance that is the subject of this opinion letter is beta-glucan soluble fiber; the letter mentions neither oatrim nor BETATRIM, and does not describe a manufacturing process that would identify clearly the subject of the letter as oatrim.

The documentation of GRAS self-determination (Ref. 1, Appendices 3 and 4) includes oatrim produced by alpha-amylase hydrolysis and with a beta-glucan content of up to approximately 10 percent. The petition suggests that the Borzelleca Consultative Services' opinion on the GRAS status of beta-glucan soluble fiber extends to the petitioners' BETATRIM products that are manufactured by hydrolysis with suitable acids or bases and that have a beta-glucan content of up to 25 percent.

FDA is not challenging the petitioners' determination that the beta-glucan-containing soluble fraction of hydrolyzed oat bran or whole oat flour produced by treatment with either alpha-amylase enzymes or with suitable acids or bases is GRAS. However, the scientific evidence submitted, as discussed in section III of this document, only supports a relationship between oatrim, i.e., the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with beta-glucan soluble fiber content up to 10 percent (dwb) and not less than that of the starting material (dwb), and a reduced risk of CHD. The substance that is the subject of this health claim does not include the soluble fraction of hydrolyzed oat bran or whole oat flour solubilized by acids or bases or containing a beta-glucan content of over 10 percent or with less beta-glucan than that of the starting material. FDA has evaluated the petitioner's position that the use of oatrim at a level providing 0.75 g beta-glucan soluble fiber per serving is safe and lawful. Based on its review, FDA concludes that the petitioners have satisfied the preliminary requirement of § 101.14(b)(3)(ii) to demonstrate, to FDA's satisfaction, that the use of oatrim, as described previously, is safe and lawful as a food ingredient at levels necessary to justify a claim (Ref. 5).

The agency has not made its own determination regarding the GRAS status of either oatrim or other BETATRIM products. Moreover, an agency determination of the GRAS status of these other BETATRIM products would not be relevant to the substance that we are authorizing for this health claim, i.e., oatrim, because such BETATRIM is different from the oatrim that is the subject of this health claim and there is insufficient evidence before the agency to support a finding on the relationship between these other BETATRIM products and a reduced risk of CHD. The agency notes that authorization of a health claim for a substance should not be interpreted as affirmation that the substance is GRAS.

As previously noted, in the 1997 soluble fiber from whole oats final rule the agency was persuaded that whole oat flour has the same effects relative to reduced risk of CHD as do oat bran and rolled oats. The agency based its conclusion on: (1) Data from a clinical study and several experimental animal studies demonstrating that consumption of whole oat flour had similar effects on blood cholesterol levels as does consumption of oat bran or rolled oats and (2) compositional similarities between whole oat flour and rolled oats (62 FR 3584 at 3586). This conclusion was corroborated by evidence that the beta-glucan soluble fiber from whole oat flour retains the same level of viscosity in the digestive tract as does that from rolled oats. Accordingly, the soluble fiber from whole oats final rule included whole oat flour, along with oat bran and rolled oats, as eligible sources of beta-glucan soluble fiber for the health claim. We now are applying those same criteria to evaluate the petitioned request to add oatrim and other BETATRIM products to the sources of beta-glucan soluble fiber listed in § 101.81(c)(2)(ii)(A).

a. Human serum lipid studies of oatrim . The criteria that the agency used to identify studies pertinent to the current review were the same as those previously used when reviewing evidence supporting the relationship between reduced risk of CHD and consumption of soluble fiber from whole oat products (61 FR 296 at 298) and consumption of psyllium husk soluble fiber (62 FR 28234 at 28237, May 22, 1997). These criteria are: (1) Include an adequate presentation of data, study design, and methods; (2) be available in English; (3) include estimates, or enough information to estimate, soluble dietary fiber intakes; (4) include direct measurement of blood total cholesterol and other blood lipids related to CHD; and (5) be conducted in persons who represent the general U.S. population. Further, factors that exclude human studies from review are: (1) Reports published only in abstract form, (2) studies using special population groups, and (3) secondary prevention studies (i.e., subjects who already have had a myocardial infarction). In addition, in this current evaluation of the relationship between beta-glucan soluble fiber from oatrim and reduced risk of CHD, the agency has included only those studies in which the substance tested was identified to be oatrim or other BETATRIM products.

Reports of five human clinical studies with data on serum lipids were submitted with this petition (Refs. 6 to 10). The study of Braaten et al., 1994 (Ref. 7) and that of Beer et al., 1995 (Ref. 8) both investigated the effects of oat gum on serum cholesterol levels in humans. The study of Torronen et al., 1992 (Ref. 6) and that of Pick et al., 1996 (Ref. 9) both investigated the effects of oat bran concentrate products on serum cholesterol levels in humans. While oat gums and oat bran concentrate are sources of oat beta-glucan soluble fiber, the subject of the petition is oatrim and other BETATRIM products, the beta-glucan-containing soluble fraction from hydrolyzed oat bran or whole oat flour. Neither oat gum nor oat bran concentrates are produced through an extraction process analogous to the process for producing oatrim. As none of these four studies utilized the substance that is the subject of the petition, they were not relevant to the present consideration and were excluded from review.

The study reported in Behall et al., 1997 (Ref. 10) investigated the effects on blood lipids of adding an oat fiber extract, identified as the oatrim developed by George Inglett, Agriculture Research Service, USDA, to diets of mildly hypercholesterolemic subjects. The oat fiber extracts had either 1.6 percent or 10.2 percent by weight beta-glucan soluble fiber (low beta-glucan and high beta-glucan, respectively). Both oat fiber extracts (high and low) were provided by Quaker Oats Co. and by ConAgra, Inc. The petitioners comment in the petition that all of the oatrim that was used in this study had been processed by the enzymatic methods licensed from George Inglett. The oat fiber extracts were added to test diets, replacing 5 percent of the fat energy with a corresponding amount of carbohydrate energy, resulting in beta-glucan soluble fiber consumption of approximately 0.8 g/day (maintenance diet, no oat fiber extract addition), 1.6 to 2.0 g/day (low beta-glucan extract added), or 5.1 to 7.6 g/day (high beta-glucan extract added). The oat fiber extracts were added to the diet in several foods including fruit juice, applesauce, muffins, cookies, cake, brownies, waffles, gelatin, yogurt, spaghetti sauce and meat loaf. The study included 23 mildly hypercholesterolemic adult subjects (age 38 to 61 years) (mean serum total-cholesterol 212 ± 7 mmole/dL; mean LDL-cholesterol 141 ± 6 mmole/dL). The maintenance diet was fed for 1 week followed by diets containing one of the oat fiber extracts for two 5-week periods in a crossover pattern. In comparison to basal serum lipid levels measured following the initial maintenance diet week, serum total-cholesterol was statistically significantly lower (p < 0.05) by 9.5 percent (low beta-glucan extract) and by 14.8 percent (high beta-glucan extract) following the oat fiber extract supplemented diet periods. The mean serum total-cholesterol levels were also statistically different (p < 0.05) between the two beta-glucan extract-supplemented diet periods. Likewise, for oat fiber extract-supplemented diets, statistically significant decreases (p < 0.05) of serum LDL-cholesterol levels of 14.8 percent (low beta-glucan extract) and by 20.8 percent (high beta-glucan extract) were observed, compared to the maintenance diet period. Serum LDL-cholesterol levels were not significantly different between the two oat fiber extract-supplemented diets. Serum HDL-cholesterol levels were not significantly different among the maintenance, low beta-glucan, or high beta-glucan diet periods.

The results of Behall et al., 1997 (Ref. 10), the only available study that evaluated the effects of oatrim on human serum lipid levels, demonstrate that consumption of a variety of foods containing oatrim produced by the enzymatic method, in amounts providing sufficient beta-glucan soluble fiber to qualify for the health claim, may contribute to statistically significant reductions in serum total- and LDL-cholesterol levels. Further, there appears to be a positive dose-response of the amount of beta-glucan soluble fiber from oatrim and the beneficial effect on serum total cholesterol.

b. Animal serum lipid studies of oatrim . The petition included reports from nine studies that investigated the effects of processed oat bran products on cholesterol metabolism in experimental animal models (Refs. 3, and 11 to 18). Among these were studies in which the oat products tested were oat gums (Refs. 11, 12, 14, and 15) or processed oat bran concentrate (Refs. 13 and 17). Results from these six studies were not directly relevant to the consideration of oatrim or other BETATRIM products as a source of beta-glucan soluble fiber eligible for the health claim, and were thus excluded from review. Three of the nine studies investigated effects of oatrim products on blood cholesterol level in experimental animals (Refs. 3, 16, and 18). Preliminary data from Inglett and Newman 1994 (Ref. 3) suggested reductions of plasma total- and LDL-cholesterol associated with the addition of oatrim containing 10-percent beta-glucan to the diet in a hypercholesterolemic chick model. These results were confirmed by Inglett et al., 1994 (Ref. 16) in a followup study with a larger sample of chicks and with an oatrim containing 8.6-percent beta-glucan. Oatrim did not affect plasma HDL-cholesterol levels in either of the above two studies (Refs. 3 and 16).

Yokoyama et al., 1998 (Ref. 18) reported on the effects of oatrim on cholesterol levels in a hypercholesterolemic hamster model. The hamster diets were supplemented with one of four oat flour products, or with cellulose. The oat flour products included a beta-glucan-enriched oat flour, a 5-percent beta-glucan oatrim, a 10-percent beta-glucan oatrim, and a beta-glucan-free hydrolyzed oatrim. All diets, except for the cellulose control and the beta-glucan-free hydrolyzed oatrim, contained equivalent amounts of beta-glucan. The two oatrim-containing diets and the beta-glucan-free oatrim hydrolyzate diet, were effective in showing statistically significant decreases (p < 0.05) in plasma total- and LDL-cholesterol levels relative to that of the cellulose-containing diet. The beta-glucan enriched oat flour-containing diet reduced neither plasma total- nor LDL-cholesterol levels. Statistically significant reductions (p < 0.05) in the plasma HDL-cholesterol level, relative to that of the cellulose-containing control diet, occurred with the two oatrim-containing diets and with the enriched oat flour-containing diet, but not with the oatrim hydrolyzate-containing diet.

Consistent with the clinical study, data from three animal models corroborate the finding that oatrim products containing beta-glucan soluble fiber lower blood total- and LDL-cholesterol levels. Furthermore, with the exception of the study employing a hamster model (Ref. 18), HDL-cholesterol levels were not significantly altered.

As discussed previously, a key factor in our decision to add whole oat flour to the food sources of beta-glucan soluble fiber eligible for the health claim was evidence that, other than being milled to a smaller particle size, the composition of whole oat flour and rolled oats is the same (62 FR 3584 at 3586). Oat bran differs from whole oat flour in that a portion of the starch-rich endosperm of whole oat flour has been removed whereas the outer soluble fiber-rich layers of the oat groat are retained. Although oatrim is derived from two of the same eligible food sources of beta-glucan soluble fiber currently authorized for the health claim, i.e., whole oat flour and oat bran, the composition of oatrim differs from each. Oatrim differs from oat bran and whole oat flour in that, in the manufacturing of oatrim, much of the starch present in the whole oat flour or remaining in the oat bran has been converted to soluble amylodextrins, and nonwater soluble components of the starting milled oat products are removed by centrifugation. However, like oat bran, the oatrim fraction produced from the manufacturing methods of Inglett and Newman, 1994 (Ref. 3) retains most of the beta-glucan soluble fiber and fiber-associated substances found in whole oat products.

As explained in the soluble fiber from whole oats final rule, the viscosity of intestinal contents is known to be a critical factor in the ability of soluble dietary fiber to reduce the risk of CHD, and soluble dietary fiber viscosity is affected in unpredictable ways by food processing, or following ingestion, by the digestive system (62 FR 3584 at 3586). Therefore, evidence demonstrating that the level of viscosity in the digestive tract of the beta-glucan-containing oatrim is similar to the level of viscosity of rolled oats, oat bran, and whole oat flour is an important factor in our decision to add oatrim as an additional source of oat beta-glucan soluble fiber eligible for the health claim. As noted in the soluble fiber from whole oats final rule (62 FR 3584 at 3587), there are no generally accepted or validated criteria for predicting which sources or processed forms of beta-glucan soluble fiber beyond oat bran, rolled oats, and whole oat flour are capable of reducing blood total- and LDL-cholesterol levels. Therefore, FDA must evaluate data that are relevant to each source of beta-glucan soluble fiber and compare these data to other authorized sources. FDA considered evidence demonstrating that the processed sources of beta-glucan soluble fiber retain the same level of viscosity in the digestive tract as soluble fiber from rolled oats to determine whether the processed forms can provide the same benefits as rolled oats (62 FR 3584 at 3586).

The petitioners submitted results of animal tests to show that beta-glucan soluble fiber from oatrim or other BETATRIM products retains the viscosity characteristics of soluble fiber in whole oat products (rolled oats, oat bran, and whole oat flour) in the rodent digestive tract (Refs. 19 to 22). Gallaher et al., 1999 (Ref. 21) reported data on rat intestinal contents supernatant viscosity (ICSV) resulting from rats consuming an oat product meal. Rats that had been fasted overnight were meal-fed a whole oat-based cereal (Cheerios, cooked and uncooked oatmeal, or cooked oat bran). Two hours later, the intestinal contents were collected, then centrifuged, and the viscosities of the resultant supernatants were determined. Differences in resultant mean ICSV values among the whole oat-based cereals tested were not statistically significant (p > 0.05). Gallaher et al., 1999 (Ref. 21) did not report data regarding the beta-glucan content of the whole oat-based cereals tested; however, based on information provided in the study report we have estimated that the whole oat-based cereal test meals contained approximately 0.12 g (Cheerios) to 0.22 g (oat bran) of beta-glucan per meal.

The ICSV data from Gallaher et al., 1999 (Ref. 21) were subsequently compared to ICSV data for the petitioners' enzymatically processed BETATRIM, also tested by Gallaher under the same test protocol (Ref. 22). The BETATRIM tested included a 4-percent beta-glucan BETATRIM, a 20-percent beta-glucan BETATRIM, and a blend of the two containing 12-percent beta-glucan. The petition identified the BETATRIM products used in this study as all having been produced with the alpha-amylase process. These test meals provided between 0.02 g and 0.10 g beta-glucan per meal. The blended 12-percent beta-glucan test meal (0.06 g beta-glucan/meal) yielded a mean ICSV value comparable to that of 0.12 to 0.22 g beta-glucan/meal from whole oat-based cereals. The mean ICSV value resulting from the high beta-glucan BETATRIM (0.10 g beta-glucan/meal) was approximately four times greater than that of 0.12 to 0.22 g beta-glucan/meal from whole oat-based cereals. These data indicate that the enzymatic processing of whole oat products into BETATRIM, and the subsequent digestion in the rat gastrointestinal tract, do not degrade the viscosity of oat beta-glucan soluble fiber relative to that of whole oat products.

The petitioners provided a report of a third viscosity study that was conducted to compare the viscosity of BETATRIM processed by the acid/base chemical method to that of BETATRIM enzymatically processed (Ref. 22). This viscosity study was conducted with the same test protocol as before, and using two sources of 20-percent beta-glucan content BETATRIM, one enzymatically processed and the other acid/base processed. The mean ICSV values for the two sources of 20-percent beta-glucan content BETATRIM were not statistically significantly different and were comparable to that of the previous study. No data were provided with respect to comparative ICSV values of enzymatic and acid/base processed BETATRIM products with beta-glucan content less than 20 percent.

The ICSV data demonstrate that the viscosity characteristics of beta-glucan soluble fiber in intact whole oat products is not degraded in the beta-glucan-containing soluble fraction of alpha-amylase hydrolyzed whole oat products. Further, the type of hydrolysis treatment, alpha-amylase enzymatic or acid/base, does not appear to have an effect on viscosity characteristics in products with beta-glucan content of 20 percent.

As noted previously, there are no generally accepted or validated criteria for predicting which sources or processed forms of beta-glucan soluble fiber are capable of reducing blood LDL-cholesterol, and therefore have an effect on CHD risk. Comments to the original soluble fiber from the whole oats proposed rule (62 FR 3584 at 3591) suggested that the effect on blood lipids from consumption of beta-glucan soluble fiber is related to both the molecular weight and the solution viscosity of the beta-glucan. The comments stated that processing methods can alter the molecular structure of the beta-glucan molecule and may cause it to lose its effect on blood cholesterol levels. The comments suggested that to ensure that the processed oat-containing food product will provide the effects associated with beta-glucan soluble fiber in the starting material, i.e., oat bran, rolled oats, and whole oat flour, the finished oat product should be tested to determine whether its beta-glucan soluble fiber has retained the physical properties, such as molecular weight, that it had in the starting material. FDA was not convinced, at the time of our initial soluble fiber from whole oats and CHD risk health claim rulemaking, that there was a need to require molecular weight or viscosity testing of foods containing oat bran, rolled oats, or whole oat flour. Although processing of whole oat substances could result in extensive depolymerization of the beta-glucan, there was clinical evidence demonstrating that most oat bran or rolled oats products processed as ready-to-eat cereals, muffins, breads, or other foods, whether they were consumed hot or cold, were effective in significantly lowering blood lipids when consumed as part of an appropriate diet.

Some studies failed to find blood lipid lowering effectiveness associated with consumption of highly processed oat gum extracts, but such studies were not relevant to FDA's analysis because FDA was authorizing the health claim for whole oat products only. As we are now proposing to extend eligible beta-glucan sources to include a processed extract of oat bran and whole oat flour, we also need to reconsider the utility of physiochemical measures of the beta-glucan soluble fiber sources that would be predictive of effectiveness in lowering blood lipids. However, we are unaware of clinical data that establish a direct correlation of any physiochemical measures (e.g., molecular weight, or viscosity) and of beta-glucan soluble fiber sources and effects on blood lipids.

Viscosity data from the ex vivo rat intestinal model of Gallaher et al. (Ref. 21) have been considered as corroborating evidence that the processing of whole oat flour or of oatrim does not significantly affect viscosity properties of the whole oat starting material from which it is made. However, we have no direct clinical evidence demonstrating the applicability of this model to predicting blood lipid-lowering effect in humans. Further, there are many methods of measuring the complex viscosity properties and the result is dependent upon the conditions of measurement. Although we do not recognize a standard method for measuring soluble viscosity applicable to a range of conditions, we do accept that soluble fiber viscosity is a major physiochemical property responsible for physiological effects of consuming soluble fiber, e.g., lowering blood lipids, and that viscosity is related to polymer size of the soluble fiber. For example, a study of viscosity as a variable in effectiveness of beta-glucan in altering blood glucose and insulin responses to an oral glucose load (Ref. 23) found a significant correlation between peak blood glucose and a combination of beta-glucan concentration and molecular weight. The agency is requesting comment and scientific data on the potential of using a molecular weight or other physiochemical properties as a predictive parameter of the ability of beta-glucan soluble fiber from highly processed sources to be effective in lowering blood lipids.

Lacking direct evidence correlating physicochemical properties of a substance with cholesterol-lowering efficacy in humans, we continue to rely on clinical intervention studies demonstrating effectiveness of a beta-glucan source in LDL-cholesterol reduction when we authorize additional eligible sources of beta-glucan soluble fiber. For this health claim, we were able to determine that a beta-glucan source from oat bran or whole oat flour (the starting materials), combined with limitations on the manufacturing process (the alpha-amylase process used to manufacture the oatrim substance tested by Behall et al. (Ref. 10)) and on the beta-glucan content of the finished product, are sufficient to ensure an adequate description of the substance that is the subject of this claim. The substance that is the subject of the claim, i.e. oatrim, is that which was used in the Behall et al. study (Ref. 10) that demonstrated a reduction in risk of CHD. Parties considering variations of the processing method used to produce the oatrim used in the Behall et al. clinical trial (Ref. 10) would need to demonstrate the bioequivalence in cholesterol reduction of their products to those oat beta-glucan sources listed in § 101.81(c)(2)(ii)(A), and submit these data to FDA in a petition to amend the health claim regulation to include such processing variations in the definition of oatrim.

Results from Behall et al., 1997 (Ref. 10) indicate that, like the effects of consuming rolled oats, oat bran, and whole oat flour, the beta-glucan-containing soluble fraction from alpha-amylase hydrolyzed oat bran and whole oat flour with a beta-glucan soluble fiber content up to 10 percent is effective in reducing blood total- and LDL-cholesterol levels, which in turn may reduce the risk of heart disease. Three studies employing various animal models also demonstrate a relationship between consumption of oatrim and a reduction in cholesterol levels. Furthermore, results from an experimental animal model of intestinal viscosity indicate that oatrim yields intestinal contents supernatant viscosity similar to that of beta-glucan soluble fiber in whole oat products. These data provide evidence of a physiological equivalence of beta-glucan soluble fiber from oatrim and beta-glucan soluble fiber from whole oat sources such as oat bran and rolled oats. Thus, these data support FDA's previous determination that, based on the totality of publicly available evidence, there is significant scientific agreement that a relationship exists between consumption of certain beta-glucan soluble fiber sources and reduced risk of CHD.

The petition requested that the amendment specifically reference Quaker-Rhodia BETATRIM brand-name products because they are the only sources with demonstrated blood cholesterol-lowering efficacy and retention of the whole oat product viscosity characteristics. We note, however, that the substance tested in the clinical cholesterol-lowering efficacy study, i.e., alpha-amylase hydrolyzed oat bran or whole oat flour, with not more than 10 percent beta-glucan content, was manufactured both by the Quaker Oats Co. and by ConAgra, Inc. Because the data upon which this health claim is based is not limited to petitioners' brand name products, FDA will not limit the health claim to these products. Instead, the health claim will be available to any substances that meet FDA's definition of oatrim, as specified previously.

Moreover, the substance tested in the clinical cholesterol-lowering efficacy study did not include acid-base hydrolyzed products or products with beta-glucan content exceeding 10 percent. Therefore, as previously discussed, the agency is not including substances other than oatrim, defined as the beta-glucan containing soluble fraction from alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan soluble fiber content up to 10 percent (dwb) and not less than that of the starting material (dwb), as an eligible source of beta-glucan for this health claim. Based on the information before us, we are persuaded that the clinical evidence of positive effects on blood cholesterol of consuming this oatrim substance, provides sufficient evidence for the agency to conclude that oatrim has the same effects relative to reduced risk of CHD as do rolled oats, oat bran and whole oat flour. Further, this conclusion is corroborated by evidence from rat intestinal contents studies that demonstrate that processing of such oatrim does not degrade the viscosity characteristics of beta-glucan soluble fiber relative to the viscosity characteristics of the whole oat sources from which it is produced. The available clinical study demonstrated efficacy of oatrim on reducing serum cholesterol with oatrim added to the diet by incorporating it into a variety of foods including fruit juice, applesauce, muffins, cookies, cake, brownies, waffles, gelatin, yogurt, spaghetti sauce, and meat loaf. These foods cover a range of viscosities, densities, and textures (Ref. 10). The foods were functional, and the petitioners did not note any matrix effects on beta-glucan availability. Therefore, we conclude that the health claim for oatrim need not be restricted to any particular food category or type (Ref. 5).

In conclusion, we find that there is sufficient evidence to amend § 101.81(c)(2)(ii)(A) by adding the beta-glucan-containing soluble fraction from alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan content up to 10 percent (dwb) and not less than that of the starting material (dwb) as the fourth source of beta-glucan soluble fiber. We are not restricting the eligible substance to the Quaker-Rhodia BETATRIM brand-name, so that all foods that meet the eligibility requirements for oatrim under § 101.81 may use the claim. To this end, we are amending § 101.81, as discussed in section V of this document, to include beta-glucan soluble fiber from oatrim.

We have also concluded that there is insufficient evidence at this time to include beta-glucan-containing acid/base hydrolyzed oat products as a substance eligible for the health claim. Although there are direct clinical data and corroborating animal plasma lipids and viscosity data to support addition of oatrim with a beta-glucan content up to 10 percent, the only available data regarding hydrolyzed oat bran or whole oat flour with a beta-glucan content over 10 percent and that is manufactured using acid/base hydrolysis, are from a single experiment comparing viscosity of two oat products containing 20-percent beta-glucan. In one oat product, the hydrolysis treatment was alpha-amylase; in the other oat product, the hydrolysis treatment was acid/base (Ref. 22). In section II.B.3 of this document, we discussed whether oatrim used at levels necessary to justify a claim has been demonstrated to be a safe and lawful substance. FDA is not challenging the petitioners' contention that BETATRIM products produced from oat bran and whole oat flour treated with either alpha-amylase, or suitable acids or bases, and containing up to 25-percent beta-glucan, are GRAS. Hence, our decision not to include hydrolyzed oat products with a beta-glucan content of more than 10 percent and beta-glucan-containing acid/base hydrolyzed oat products, as substances which may be used in a food to make the food eligible to bear a claim about such sources of soluble fiber and reduced risk of CHD, rests on the lack of sufficient data to demonstrate such a relationship. We will evaluate any clinical data submitted in response to this interim final rule to demonstrate, by validated measures, that a relationship exists between consumption of hydrolyzed oat products with beta-glucan content over 10 percent and of acid/base hydrolyzed oat products and a reduced risk of CHD, to determine whether such data warrant a modification to this rule.

In a notice published in the Federal Register of February 11, 2002 (67 FR 6265), FDA announced that a food additive petition (FAP 2A4731) had been filed by Ecolab Inc., Ecolab Center, 370 N. Wabasha St., St. Paul, MN 55102, proposing to amend the food additive regulations in Part 173 Secondary Direct Food Additives Permitted in Food for Human Consumption (21 CFR part 173) to provide for the safe use of a mixture of peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1,1-diphosphonic acid as an antimicrobial agent on meat parts, trim, and organs.

The agency has previously approved the use of the subject mixture on red meat carcasses (§ 173.370(b)(1)) in response to an earlier petition submitted by Ecolab, Inc. In the evaluation that led to that regulation, the agency considered “red meat” to include the species cattle, swine, sheep, goats, and equine. The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) uses the term “meat” to refer to these species (9 CFR 301.2). Thus, FDA is removing the term “red” as a descriptor for “meat carcasses” in § 173.370(b)(1) to make its terminology consistent with FSIS.

FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that the proposed use of the additive is safe and the additive will achieve its intended technical effect as an antimicrobial agent on meat carcasses, parts, trim, and organs.

Therefore, FDA is approving the use of a mixture of peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1, 1-diphosphonic acid as an antimicrobial agent on meat carcasses, parts, trim, and organs. Accordingly, § 173.370 is amended as set forth below.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

In the notice of filing, FDA gave interested parties an opportunity to submit comments on the petitioner's environmental assessment. FDA received no comments in response to that notice.

The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch ( see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (see ADDRESSES ) written or electronic objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which the objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The San Joaquin Valley Ozone Nonattainment Area includes the following counties in California's central valley: San Joaquin, part of Kern, 1 Fresno, Kings, Madera, Merced, Stanislaus and Tulare.

When the CAA was amended in 1990, each area of the Country that was designated nonattainment for the 1-hour ozone standard, including the San Joaquin Valley, was classified by operation of law as “marginal,” “moderate,” “serious,” “severe” or “extreme” depending on the severity of the area's air quality problem. CAA sections 107(d)(1)(C) and 181(a). Each of these CAA classifications has different requirements, with the most stringent requirements for “extreme” areas. Based on its air quality during the 1987-1989 period, the San Joaquin Valley nonattainment area was initially classified as serious with an attainment date of no later than November 15, 1999. See 56 FR 56694 (November 6, 1991) and CAA section 181(a)(1).

On June 19, 2000, EPA proposed to find that the San Joaquin Valley had failed to attain the 1-hour ozone national ambient air quality standards (NAAQS) by the serious area attainment date of November 15, 1999. 65 FR 37926. A final finding of failure to attain was published on October 23, 2001 (66 FR 56476) and the Valley was thus reclassified by operation of law as a severe ozone nonattainment area (effective December 10, 2001). Along with the severe classification, the Valley became subject to new planning requirements under section 182(d) of the CAA. Under section 182(d), severe area plans must meet the requirements for serious area plans in addition to those for severe areas. Moreover, the severe area plan revisions for the area must also meet the more general nonattainment provisions of section 172(c). In its final reclassification action, EPA set May 31, 2002 as the due date for submittal of plan revisions addressing these requirements. 66 FR 56481.

On June 18 and August 6, 2002, California submitted plan revisions addressing several of the severe area requirements for the San Joaquin Valley (revised title V operating permit and new source review programs to address the new lower 25 ton per year major source cutoff for volatile organic compounds (VOCs) and oxides of nitrogen (NO X ) and the offset ratio of 1.3:1; rule requiring fees for major sources should the area fail to attain by 2005; and RACT rules for most sources subject to the lower major source applicability threshold). Furthermore, on September 6, 2002, California submitted San Joaquin Valley Air Pollution Control District commitments to adopt new and revised control measures.

While California's submittals address several of the severe area requirements for the San Joaquin Valley and help ensure progress towards clean air, there are still requirements which have not been addressed. Specifically, the State has not submitted a demonstration of attainment of the ozone NAAQS by no later than 2005 (sections 181(a) and 182(c)(2)(A)), a demonstration (known as reasonable further progress or rate of progress) of creditable emission reductions of ozone precursors of at least 3% per year until the attainment year (section 182(c)(2)(B)), a RACT rule for lime kilns addressing the 25 ton per year major source cutoff (section 182(b)(2)(C)), an inventory (section 172(c)(3)) and contingency measures (section 172(c)(9)). Thus, EPA is today making a finding of failure to submit SIP revisions addressing these CAA required elements.

If California does not submit the required plan revisions within 18 months of the effective date of today's rulemaking, pursuant to CAA section 179(a) and 40 CFR 52.31, the offset sanction identified in CAA section 179(b) will be applied in the affected area. If the State has still not made a complete submittal 6 months after the offset sanction is imposed, then the highway funding sanction will apply in the affected area, in accordance with 40 CFR 52.31. 2 The 18-month clock will stop and the sanctions will not take effect if, within 18 months after the date of the finding, EPA finds that the State has made a complete submittal addressing these severe area ozone requirements for the San Joaquin Valley. In addition, CAA section 110(c)(1) provides that EPA must promulgate a federal implementation plan (FIP) no later than 2 years after a finding under section 179(a) unless EPA takes final action to approve the submittal within 2 years of EPA's finding.

This final action is effective on September 18, 2002. Under the Administrative Procedures Act (APA), 5 U.S.C. 553(d)(3), an agency rulemaking may take effect before 30 days after the date of publication in the Federal Register if an agency has good cause to mandate an earlier effective date. Today's action concerns SIP revisions that are already overdue and the State has been aware of applicable provisions of the CAA relating to overdue SIPs. In addition, today's action simply starts a “clock” that will not result in sanctions for 18 months, and that the State may “turn off” through the submission of a complete SIP submittal. These reasons support an effective date prior to 30 days after the date of publication.

This final agency action is not subject to the notice-and-comment requirements of the APA, 5 U.S.C. 533(b). EPA believes that because of the limited time provided to make findings of failure to submit regarding SIP submissions, Congress did not intend such findings to be subject to notice-and-comment rulemaking. However, to the extent such findings are subject to notice-and-comment rulemaking, EPA invokes the good cause exception pursuant to the APA, 5 U.S.C. 553(d)(3). Notice and comment are unnecessary because no EPA judgment is involved in making a nonsubstantive finding of failure to submit SIPs required by the CAA. Furthermore, providing notice and comment would be impracticable because of the limited time provided under the statute for making such determinations. Finally, notice and comment would be contrary to the public interest because it would divert Agency resources from the critical substantive review of submitted SIPs. See 58 FR 51270, 51272, note 17 (October 1, 1993); 59 FR 39832, 39853 (August 4, 1994).

The Office of Management and Budget has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This 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, as specified in Executive Order 13132, because it does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

This final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because findings of failure to submit required SIP revisions do not by themselves create any new requirements. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that today's action does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. The CAA provision discussed in this notice requires states to submit SIPs. This notice merely provides a finding that California has not met that requirement. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical. EPA believes that VCS are inapplicable to today's action because it does not require the public to perform activities conducive to the use of VCS.

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 rule 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 December 2, 2002. 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).)

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

A notice of proposed rulemaking was published on this action on August 2, 2002 (67 FR 50391). EPA has also published a notice regarding the Baton Rouge area's potential eligibility for an attainment date extension on May 9, 2001 (66 FR 23646). EPA received comments on these proposals. EPA has also published a related notice: the “Extension of Attainment Dates for Downwind Transport Areas,” 64 FR 14441 (March 25, 1999). That notice announced EPA's interpretation of the Act regarding the possibility of extending attainment dates for ozone nonattainment areas that had been classified as moderate or serious for the 1-hour ozone standard and which are downwind of areas that have interfered with their ability to demonstrate attainment. In that notice EPA also noted that we intended to finalize our interpretation only when we applied this policy in the context of individual rulemakings addressing specific attainment demonstrations and requests for attainment date extensions. We have received comments on our application of this policy to the Baton Rouge area. Therefore, in this final rule, EPA responds to adverse comments on these proposed rulemakings and notices. For details on the SIP submittals and EPA's analysis of the submittals, refer to the notices of the proposed rules referenced above in this paragraph, and the technical support documents for the August 2, 2002, and May 9, 2001, proposals.

EPA is making this final rulemaking effective immediately. Section 553(d) of the Administrative Procedure Act generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register . However, if an Agency identifies a good cause, section 553(d)(3) allows a rule to take effect earlier, provided that the Agency publishes its reasoning in the final rule. EPA is making this action effective immediately because the effective date of the nonattainment determination and reclassification (which is being withdrawn as a result of this final rule) is imminent. In addition, EPA finds good cause for making this action effective immediately because, in part, it relieves a restriction that would otherwise go into effect.

This section provides additional information by addressing the following questions:

The Baton Rouge ozone nonattainment area encompasses the East Baton Rouge, West Baton Rouge, Ascension, Iberville, and Livingston Parishes (40 CFR 81.319). The State of Louisiana made several submittals to us relating to the ozone attainment demonstration and their request for an extension of the attainment date for the Baton Rouge ozone nonattainment area. The submittals listed below relate directly to EPA's final action described in this document:

(a) On December 31, 2001, LDEQ submitted an ozone attainment demonstration and transport SIP revision. The SIP revision included:

i. A revision to the 15% ROPP for the control of Volatile Organic Compounds (VOC) emissions in the Baton Rouge area. The 15% Rate ROPP was approved by EPA on October 22, 1996 (61 FR 54737).

ii. Revisions to the 1990 base year emissions inventory. The inventory was approved on July 2, 1999 (64 FR 35930).

iii. Revisions to the Post-1996 ROPP. The Post-1996 ROPP, also referred to as the 9% ROPP, was approved on July 2, 1999 (64 FR 35930).

iv. Revisions to the Inspection and Maintenance (I/M) program.

v. Attainment MVEBs for 2005 for VOCs and Nitrogen Oxides (NO X ).

vi. An enforceable commitment to submit revised MVEBs within 24 months after the release of MOBILE6.

vii. An enforceable commitment for mid-course review.

viii. An enforceable transportation control measure referred to as the Advanced Transportation Management System.

ix. An emissions control strategy that incorporates federal, state, and local control measures.

x. Revisions to Louisiana's New Source Review (NSR) rules.

xi. Substitute contingency measures.

(b) On February 27, 2002, LDEQ submitted final rules for the emission reductions credit banking program.

(c) On February 27, 2002, LDEQ also submitted final revisions to the contingency measures proposed in the December 31, 2002, SIP submittal.

(d) On May 20, 2002, LDEQ submitted a letter concerning the revisions to the rulemaking dealing with VOC emissions from industrial wastewater.

(e) On July 25, 2002, the Governor submitted Louisiana's final rule for the control of emissions of nitrogen oxides. Prior to that, on February 1, 2002, LDEQ had submitted changes to the proposed rule for control of NO X emissions and on April 8, 2002, LDEQ had submitted a letter requesting parallel processing of revisions to the State's NO X regulations.

EPA has taken separate final actions on other parts of the Baton Rouge SIP, including the I/M Program, NO X regulations, NSR, emissions reductions credit banking, and Contingency Measures. EPA also approved SIP revisions dealing with VOC emissions from industrial wastewater which are published at 67 FR 41840 (June 20, 2002). In this final rulemaking the following are considered: The ozone attainment demonstration plan and its associated MVEBs; the transport SIP related materials; the RACM analysis; the revisions to the 1990 base year inventory, the 15% ROPP, and the Post-1996 ROPP, the attainment date extension, and a withdrawal of nonattainment determination and reclassification.

On May 9, 2001 (66 FR 23646), EPA proposed to find that the Baton Rouge ozone nonattainment area had not attained the 1-hour ozone national ambient air quality standard (NAAQS) by the attainment date for serious nonattainment areas (November 15, 1999). Also in that notice, EPA issued a notice of the Baton Rouge area's potential eligibility for an attainment date extension, pursuant to EPA's, “Guidance on Extension of Air Quality Attainment Dates for Downwind Transport Areas' (hereinafter referred to as the attainment date extension policy) (Richard D. Wilson, Acting Assistant Administrator for Air and Radiation) issued on July 16, 1998. In the May 9, 2001, Federal Register , EPA proposed to finalize the reclassification of the Baton Rouge nonattainment area only after the area had an opportunity to qualify for an attainment date extension under the attainment date extension policy.

Subsequent to our May 9, 2001, proposed rulemaking, a relevant court decision was issued which affected EPA's proposed rulemaking for the Baton Rouge area. EPA was in the process of reviewing the Attainment Plan/Transport SIP when the United States District Court for the Middle District of Louisiana entered a Judgment on March 7, 2002, ordering EPA to determine, by June 5, 2002, whether the Baton Rouge area had attained the applicable ozone standard under the CAA. LEAN v. Whitman , No. 00-879-A. In compliance with the Court's Order, EPA signed on June 5, 2002, and published in the Federal Register on June 24, 2002, (67 FR 42688) our determination that the Baton Rouge area did not attain the 1-hour ozone standard by November 15, 1999 in the Federal Register (67 FR 42688). By operation of law, that determination would result in the Baton Rouge area being reclassified from a serious to a severe nonattainment area on the effective date of that rule. EPA concurrently proposed to extend the effective date of our determination from August 23, 2002, to October 4, 2002 (67 FR 42697, June 24, 2002). On August 20, 2002, we published an action finalizing the modification of the effective date of our June 24, 2002, final reclassification from August 23, 2002, until October 4, 2002.

In the June 24, 2002, proposed rulemaking, EPA also set forth its intent to withdraw the final determination and reclassification, if EPA granted the State an attainment date extension before the effective date of the determination and reclassification rule.

On August 2, 2002 (67 FR 50391), EPA proposed to approve Louisiana's 1-hour ozone attainment demonstration SIP for the Baton Rouge ozone nonattainment area. Also, in that notice we proposed to approve an extension of the ozone attainment date for the Baton Rouge area to November 15, 2005, while retaining the area's classification as a serious ozone nonattainment area if EPA took final action to approve the State's ozone attainment demonstrations. EPA also proposed other related actions in the August 2, 2002, proposal.

Additionally, EPA has taken separate actions on other related revisions to the Baton Rouge SIP, including the I/M Program (proposed at 67 FR 44410, July 2, 2002), NO X regulations (proposed at 67 FR 30638, May 7, 2002, and 67 FR 48095, July 23, 2002), NSR (proposed at 67 FR 48090, July 23, 2002), emissions reductions credit banking (proposed at 67 FR 48083, July 23, 2002), Contingency Measures (proposed at 67 FR 35468, May 20, 2002), and SIP revisions dealing with VOC emissions from industrial wastewater (67 FR 41840, June 20, 2002). Please see the related final actions which published in the Federal Register on September 26, September 27, and September 30, 2002.

EPA has received comments on portions of our May 9, 2001; June 24, 2002; and August 2, 2002, proposed rules. The Tulane Environmental Law Clinic and the Louisiana Environmental Action Network (LEAN) submitted adverse comments on portions of the May 9, 2001; June 24, 2002; and August 2, 2002, proposed rules. Earthjustice submitted adverse comments on portions of the August 2, 2002, proposed rule. Louisiana Generating, LLC and Big Cajun I and II (LAGen), submitted adverse comments on Section 4.2.1 of the SIP in response to our August 2, 2002, proposed approval. All other comments on the proposals supported EPA's proposed actions. In this final rule, EPA responds to the adverse comments received in response to the relevant proposals. EPA also responds to relevant adverse comments on its March 25, 1999, notice of interpretation regarding the attainment date extension policy (64 FR 14441).

On December 31, 2001, Louisiana submitted motor vehicle emissions budgets for the 2005 attainment year for the Baton Rouge area in their SIP. The attainment year MVEBs established by this plan that we are approving are 15.48 tons per day for VOC and 34.26 tons per day for NO X for the Baton Rouge area. These budgets were posted on the EPA website for public comment. No comments were received by EPA (67 FR 46970). EPA is approving these MVEBs because they are consistent with the control measures in the SIP, and the SIP as a whole demonstrates attainment of the 1-hour ozone standard. The rationale for our approval is detailed in the August 2, 2002, proposed action. Louisiana has committed to revise its 2005 MVEBs within two years after the release of MOBILE6. Louisiana has committed to not performing transportation conformity determinations during the second year following the release of MOBILE6 unless and until the State submits an MVEB which is developed using MOBILE6 and which we find adequate.

All States whose attainment demonstrations include the effects of the Tier 2/sulfur program have committed to revise and resubmit their MVEBs after we release MOBILE6. If a state fails to meet its commitment to submit revised budgets using MOBILE6, EPA could make a finding of failure to implement the SIP, which would start a sanctions clock under section 179 of the Act.

The final approval action we are taking today will be effective for conformity purposes only until revised MVEBs are submitted and we have found them adequate. In other words, the budgets we are approving today will apply for conformity purposes only until there are new, adequate budgets consistent with the State's commitments to revise the budgets. The new budgets will apply for conformity purposes after we find them adequate.

We are limiting the duration of our approval in this manner because we are only approving the attainment demonstration and the budgets based on the State's commitment to revise them. Therefore, if we confirm that the revised budgets are adequate, they will be more appropriate than the budgets we are approving for conformity purposes now.

If the revised budgets raise issues about the sufficiency of the attainment demonstration, we will work with the State to address the issues. If the revised budgets show that motor vehicle emissions are lower than the budgets we approve, a reassessment of the attainment demonstration's analysis will be necessary before reallocating the emission reductions or assigning them to the MVEB as a safety margin. In other words, the State must assess how its original attainment demonstration is impacted by using MOBILE6 v MOBILE5 before they reallocate any apparent motor vehicle emission reductions resulting from the use of MOBILE6.

Under the 1990 Clean Air Act Amendments (CAAA), States have the responsibility to inventory emissions contributing to NAAQS nonattainment, to track these emissions over time, and to ensure that control strategies are being implemented that reduce emissions and move areas towards attainment. The CAAA require ozone nonattainment areas designated as moderate, serious, severe, and extreme to submit a plan within three years of 1990 to reduce VOC emissions by 15 percent within six years after 1990. The baseline level of emissions, from which the 15 percent reduction is calculated, is determined by adjusting the base year inventory to exclude biogenic emissions and to exclude certain emission reductions not creditable towards the 15 percent. The 1990 base year emissions inventory is the primary inventory from which the periodic inventory, the Reasonable Further Progress projection inventory, and the modeling inventory are derived. 1 The base year inventory plays an important role in modeling demonstrations for areas classified as moderate and above.

States containing ozone nonattainment areas classified as marginal to extreme were required under section 182(a)(1) of the 1990 CAAA to submit a final, comprehensive, accurate, and current inventory of actual ozone season, weekday emissions from all sources by November 15, 1992. This inventory is for calendar year 1990 and is denoted as the base year inventory. It includes both anthropogenic and biogenic sources of VOC, NO X , and carbon monoxide (CO).

Section 182(c)(2)(B) of the Act requires each State having one or more ozone nonattainment areas classified as serious or higher to develop a plan by November 15, 1994, that provides for additional actual VOC reductions of at least three percent per year, averaged over each consecutive three year period, beginning six years after enactment of the Act, until such time as these areas have attained the NAAQS for ozone. EPA approved the revisions to the 9% ROPP for the Baton Rouge area on July 2, 1999 (64 FR 35930).

The revisions we are approving today consist of revisions to the 1990 Base Year Emissions Inventory, the 15% ROPP, and the 9% ROPP, which were submitted as part of the December 31, 2001, Attainment Plan/Transport SIP. Specifically, they were submitted as part of the substitute contingency measures. The substitute contingency measures are the subject of a separate EPA rulemaking action which published in the Federal Register on September 26, 2002.

The revisions consisted of emission reductions resulting from the installation of VOC emission controls at the Trunkline Gas Company—Patterson Compressor Station (hereinafter referred to as Trunkline or Trunkline facility) in St. Mary Parish. The Trunkline facility is located approximately 40 kilometers from the Baton Rouge ozone nonattainment area. In 1997, EPA issued a policy allowing 1-hour ozone nonattainment areas to take credit in their Post-1996 ROPP  2 for emission reductions obtained from sources outside the designated nonattainment area, provided the sources are no farther away than 100 km (for VOC sources) or 200 km (for NO X sources) away from the nonattainment area. 3

The Trunkline Gas Company had not accounted for 13.4 tons per day of VOC emissions. As a result, the VOC emissions from this facility had not been included in the point source emissions inventory for 1990. Emissions reported in a corrected 1992 annual emissions inventory submitted to LDEQ on June 6, 1997, are the best estimate of the source's 1990 base year emissions. These emissions were added back to the 1990 base year emissions inventory. The revised 1990 VOC base year inventory that included these Trunkline emissions ( i.e. , 13.4 tons per day) would result in a total of 204.6 tons per day revised 1990 base year inventory.

An additional 2.0 tons per day of emission reductions required were identified in the 15% ROPP revisions. The additional 2.0 tons per day were offset by 1.4 tons per day “surplus” 9% ROPP reduction from the Trunkline permit plus 0.6 tons per day of point source reductions (163 tons per year or 0.45 tons per day of VOCs from the Dow Chemical permit and 56 tons per year or 0.15 tons per day of VOCs from the BASF Corporation permit).

There were also an additional 1.2 tons per day of reductions required for the 9% ROPP identified in the revisions. These were taken from the 13.0 tons per day Trunkline emissions reductions that were netted from the post-90 emissions growth.

For additional detailed discussions on the above mentioned revisions please see our August 2, 2002, rulemaking (67 FR 50396). EPA received adverse comments concerning these revisions. Those comments are addressed elsewhere in this notice.

Section 172(c)(1) of the Act requires attainment demonstration SIPs to provide for the implementation of all RACM as expeditiously as practicable. EPA has previously provided guidance interpreting the RACM requirements of 172(c)(1). (See 57 FR 13498, 13560.) We also discussed the RACM requirements in our August 2, 2002, Federal Register proposal. EPA has reviewed the state's submitted analyses, the process used to review and select transportation control measures, the state's evaluation of potential stationary source control measures, and the attainment year emissions inventories for the Baton Rouge area. While the Act requires nonattainment areas to implement available RACM measures, EPA does not believe that section 172(c)(1) requires implementation of potential RACM measures that either require intensive and costly implementation efforts or that produce relatively small emissions reductions that will not accelerate attainment of the ozone standard.

Analyses conducted by LDEQ concluded that the additional set of evaluated measures are not reasonably available for the Baton Rouge area, because: (a) Some would require an intensive and costly effort for numerous small area sources, and (b) the measures would not produce emission reductions sufficient to advance the attainment date in the Baton Rouge area. Therefore, the measures were rejected as possible RACM.

EPA received adverse comments on our proposed finding that Louisiana has satisfied the RACM requirements of the Act. Those comments are addressed below. EPA believes that the reductions from the measures rejected by the State would not accelerate attainment of the ozone NAAQS. Based upon EPA's review of the State's analysis and submission, the explanation provided in our August 2, 2002, proposed rule (67 FR 50391) and our interpretation of the Act, EPA is approving Louisiana's RACM analysis.

The attainment demonstration SIP must meet applicable criteria as detailed in the Act. The specific requirements of the Act for serious ozone nonattainment areas are found in section 182(c). Section 172 provides the general requirements for nonattainment plans. Refer to our August 2, 2002, proposal (67 FR 50391) for further details of requirements for attainment demonstrations.

EPA guidance published in 1996 provides that states may rely on a modeled attainment demonstration supplemented with additional weight of evidence (WOE) to demonstrate attainment (“Guidance on the Use of Modeled Results to Demonstrate Attainment of the Ozone NAAQS,” EPA-454/B-95-007, June 1996). In our August 2, 2002, Federal Register notice we listed documents containing many of EPA's guidelines affecting the content and review of ozone attainment demonstration submittals. (67 FR 50394.) In that notice, we also described in detail the modeling requirements for an attainment demonstration as well as the additional analyses that may be considered when the deterministic approach, as described in EPA guidance, does not show attainment (67 FR 50394-50395). In the same Federal Register document, EPA details the statistical and modeling data presented in the state's attainment demonstration that support the validity of the ozone modeling results and the adequacy of the adopted ozone attainment strategies. The State concludes, and EPA concurs, that the modeling system performs at an acceptable level because it satisfactorily reproduces peak ozone concentrations relative to the monitored peak ozone concentrations. The modeling system adequately simulates the observed magnitude and spatial and temporal patterns of monitored ozone concentrations. Furthermore, the modeling results accurately differentiate between days with marginal ozone levels and days with elevated ozone concentrations. Therefore, based on the modeling and WOE results presented by the State which confirm the adequacy of the adopted emission control strategy, EPA is approving the State's attainment demonstration. EPA also finds that the appropriate attainment date is November 15, 2005, based on the attainment demonstration. EPA received adverse comments regarding the State's modeled attainment demonstration. These comments and our responses are summarized elsewhere in this notice.

EPA's policy regarding an extension of the ozone attainment date for the Baton Rouge area was set forth in EPA's notice of proposed rulemakings dated May 9, 2001 (66 FR 23646, 23650-23651) and August 2, 2002 (67 FR 50391). On July 16, 1998, a guidance memorandum entitled “Extension of Attainment Dates for Downwind Transport Areas” was issued by EPA and was published in a notice of interpretation on March 25, 1999 (64 FR 12221). In it, EPA set forth its interpretation of the Act regarding the extension of attainment dates for ozone nonattainment areas that have been classified as moderate or serious for the 1-hour ozone standard, and which are downwind of areas that have interfered with the moderate and serious nonattainment areas's attainment of the ozone standard by dates prescribed in the Act. EPA stated that it will consider extending the attainment date for an area or a state that:

1. Has been identified as a downwind area affected by transport from either an upwind area in the same state with a later attainment date or an upwind area in another state that significantly contributes to downwind ozone nonattainment;

2. Has submitted an approvable attainment demonstration with any necessary, adopted local measures, and with an attainment date that shows it will attain the 1-hour standard no later than the date that the emission reductions are expected from upwind areas in the final NO X SIP call and/or the statutory attainment date for upwind nonattainment areas, i.e. , assuming the boundary conditions reflecting those upwind emission reductions;

3. Has adopted all applicable local measures required under the area's current ozone classification and any additional emission control measures demonstrated to be necessary to achieve attainment, assuming the emission reductions occur as required in the upwind areas; and

4. Has provided that it will implement all adopted measures as expeditiously as practicable, but no later than the date by which the upwind reductions needed for attainment will be achieved.

Louisiana satisfied the criteria for an attainment date extension as follows:

1. EPA finds that Louisiana has demonstrated that it is a downwind area affected by transport from the Houston area and that Houston contributes to the Baton Rouge area's ozone nonattainment;

2. As explained elsewhere in this notice, EPA finds that the State of Louisiana has submitted an approvable attainment demonstration that provides for attainment no later than the date emissions reductions are expected from the upwind area. Furthermore, all of the control measures needed for attainment have been adopted and submitted to EPA. These measures include all serious area requirements under section 182(c).

3. EPA has determined that Louisiana has adopted local measures required by the Act for the area's current classification as a serious nonattainment area. See Louisiana's SIP submittals and 67 FR 50391 (August 2, 2002) and the references cited therein for a discussion of the local measures adopted by the State.

4. With respect to implementation of all adopted measures as expeditiously as practicable but no later than the time upwind controls are expected, Louisiana has demonstrated to EPA that all control measures would be in place by November 15, 2005. This is two years in advance of the Houston, Texas, upwind area that is contributing to the Baton Rouge area's nonattainment. Since the local measures adopted by Louisiana necessary for attainment will be implemented no later than 2005 and EPA finds that they will be implemented as expeditiously as practicable, the State has shown that this element of the attainment date extension policy has been satisfied.

EPA therefore concludes, consistent with the attainment date extension policy, the State has met the criteria for an attainment date extension. EPA is thus extending the attainment date for the Baton Rouge area to November 15, 2005, to allow the upwind reductions to occur before attainment is required. Additional background information on EPA's attainment date extension policy can be found in the following Federal Register notices:

EPA received comments regarding the basis for and application of the extension policy in granting the Baton Rouge ozone nonattainment area an attainment date extension. Those comments and our responses to comments are summarized elsewhere in this document.

On May 10, 2000, the Governor of Louisiana requested an attainment date extension for the Baton Rouge area. On May 9, 2001, EPA proposed its finding that the Baton Rouge area did not attain the 1-hour ozone NAAQS by the applicable attainment date (66 FR 23646). In that proposed action, we also stated that Louisiana was seeking an extension of its attainment date pursuant to EPA's attainment date extension policy. EPA proposed to take final action on the determination of nonattainment and reclassification of the Baton Rouge area only after the area had received an opportunity to qualify for an attainment date extension under the attainment date extension policy. Louisiana submitted an Attainment Plan/Transport SIP on December 31, 2001, for the Baton Rouge area. EPA was in the process of reviewing the Attainment Plan/Transport SIP when, on March 7, 2002, the United States District Court for the Middle District of Louisiana entered a Judgment ordering EPA to determine, by June 5, 2002, whether the Baton Rouge area had attained the applicable ozone standard under the CAA. LEAN v. Whitman , No. 00-879-A. In compliance with the Court's Order, EPA signed on June 5, 2002, and published in the Federal Register on June 24, 2002, (67 FR 42688) our determination that the Baton Rouge area did not attain the 1-hour ozone standard by November 15, 1999.

On June 24, 2002, EPA published its “Determination of Nonattainment as of November 15, 1999, and Reclassification of the Baton Rouge Ozone Nonattainment Area; State of Louisiana; Final Rule” (67 FR 42688). The effective date of that Determination and Reclassification was initially set at August 23, 2002. However, in a separate notice the same day (67 FR 42697), EPA proposed to extend the effective date of the Determination and Reclassification until October 4, 2002. On August 20, 2002 (67 FR 53882), EPA finalized the modification of the effective date of the Determination of Nonattainment as of November 15, 1999, and Reclassification of the Baton Rouge Ozone Nonattainment Area, extending it until October 4, 2002.

In our August 2, 2002, Federal Register document (67 FR 50391), EPA proposed to withdraw the Notice of Determination of Nonattainment and Reclassification if we approved an attainment date extension prior to the effective date of the Determination of Nonattainment. As noted in our August 2, 2002, proposal, EPA believes this is appropriate for a number of reasons.

Since we are today granting an extension until November 15, 2005, for attainment of the 1-hour ozone standard, EPA's obligation under section 181(b)(2)(A) of the Act to determine attainment is thereby shifted into the future. As a result, we are hereby withdrawing the published nonattainment determination and the consequent reclassification, which has not yet gone into effect. Therefore, the Baton Rouge area retains its classification as a serious ozone nonattainment area. As stated previously, comments on our proposal to extend the attainment date are addressed below. In today's action, we are withdrawing the Notice of Nonattainment Determination and Reclassification, prior to its becoming effective. EPA received adverse comments relating to our proposal to withdraw the nonattainment determination and consequent reclassification in the event we granted an attainment date extension. Those adverse comments are addressed below in this document.

EPA received comments from the public on the Notices of Proposed Rulemaking published on May 9, 2001; June 24, 2002; and August 2, 2002, for the proposed approval of the Baton Rouge's ozone attainment demonstration and attainment date extension. EPA received adverse comments from Tulane and LEAN for our May 9, 2001 and the August 2, 2002, proposals. We received adverse comments from Earthjustice on our August 2, 2002, proposal. EPA also received comments in support of the proposals from 24 commenters.

EPA sets forth below in this section our responses to adverse comments received on these notices which are relevant to this rulemaking. EPA also received comments relating to the proposal to determine that the Baton Rouge area did not attain the ozone standard by November 15, 1999. These comments relate primarily to the necessity of making the nonattainment determinations, and the appropriate attainment date if the area were reclassified. In EPA's June 24, 2002, final rule, EPA responded to adverse comments on the proposed determination that the area did not attain the standard by November 15, 1999, and finalized the reclassification to severe nonattainment. (67 FR 42688, 42693-42695). The effective date of that action was extended to October 4, 2002. Today we are withdrawing our June 24, 2002, final rule.

Finally, some of the comments received in Docket A-98-47 on EPA's notice regarding “Extension of Attainment Dates for Downwind Transport Areas” 64 FR 12221 (March 25, 1999), are relevant to this rulemaking. EPA incorporates its responses to those comments, set forth in 66 FR 586, 66 FR 634, 66 FR 666 (January 3, 2001), and 66 FR 26913 (May 15, 2001), 66 FR 33996 (June 26, 2001), 66 FR 33996 (June 26, 2001), and 67 FR 30574 (May 7, 2002), insofar as herein relevant.

The following discussion summarizes and responds to all adverse comments:

Comment 1: Eleven comment letters were received with statements of support for EPA's proposed eligibility for a transport-based attainment date extension. Two comment letters were received in opposition to the transport-based attainment date extension. The commenters in support believed that the Baton Rouge area was affected by the transport of ozone from the Houston-Galveston, Texas, nonattainment area (hereinafter referred to as Houston). The commenters in opposition believed that either the Baton Rouge area did not meet the conditions under EPA's transport-based attainment date extension policy, that the time for making an attainment determination was overdue, and/or the Act did not give EPA the authority to grant the transport-based attainment date extension.

Response 1: In this final rule, EPA responds to the relevant adverse comments on EPA's legal authority to extend the Baton Rouge area's attainment date received in response to that proposal. The responses to comments in a number of prior rulemakings concerning the attainment date extensions granted in Washington, DC, Springfield, Massachusetts, Greater Connecticut, Beaumont, Texas, the St. Louis area, and Atlanta, Georgia, are relevant and responsive to the comments received on Baton Rouge. In those prior rulemakings, EPA responded to similar challenges to the legality of the attainment date extension policy, and EPA therefore incorporates its responses to those comments, set forth in 66 FR 586, 66 FR 634, 66 FR 666 (January 3, 2001), 66 FR 26913 (May 15, 2001), 66 FR 33996 (June 26, 2001), and 67 FR 30574 (May 7, 2002), insofar as herein relevant.

Many of the legal arguments and other issues raised in the comments addressing the attainment date extension proposed in Baton Rouge have also been addressed in the briefs EPA has filed in litigation concerning the extensions in Washington, DC Sierra Club v. Whitman, Nos. 01-1070 (DC Cir.), St. Louis, Sierra Club v. EPA 01-2844, No. 01-2845 (7th Cir.), Sierra Club v. Whitman, Nos. 01-5123 and 01-5299 (DC Cir.), and Beaumont, Sierra Club v. EPA, No. 01-60537 (5th Cir.). These briefs have been placed in the docket for this rulemaking and are incorporated herein by reference.

Commenters cite to prior case law in support of such propositions as: a list of specific remedial provisions excludes the possibility of inferring that Congress intended any additional forms of relief; an agency cannot substitute its policy choices for those of Congress; the attainment deadlines are central to the CAA and cannot be adjusted. EPA has previously set forth its views on these issues in its prior responses and in its briefs. None of the cases or arguments cited by the commenters alters these views, or undermines EPA's authority to interpret the text of the statute in its full context so as to give effect to Congressional intent. EPA is implementing the attainment date extension not as a mere Agency policy preference, but in order to fulfill Congressional intent. Moreover, even in the absence of explicit statutory authority, EPA may grant extensions of time under the CAA where it concludes that Congress would have done the same had it foreseen the circumstances presented. NRDC v. EPA, 22 F.3d 1125 (D.C. Cir. 1994).

Please see the responses to related comments concerning Baton Rouge's eligibility for an extension in the comment section below.

Twenty-seven comment letters were received on our August 2, 2002, proposed approval rulemaking. Of these twenty-seven letters, we received four comment letters with adverse comments dealing with our proposed action.

Comment 2: One commenter contends that EPA lacks statutory authority to approve the request for an attainment date extension based on EPA's attainment date extension policy. The commenter asserts that the current classification for the Baton Rouge area is “severe” and not “serious.” The commenter contends that EPA has already determined that the area failed to attain the ozone standard within the meaning of section 181(b)(2)(A) of the Act, and that, therefore, the Baton Rouge area was reclassified by operation of law, despite EPA's refusal to acknowledge this. The commenter incorporates by reference its arguments as to the legality of the attainment date extension policy contained in its briefs in Sierra Club v. EPA, 294 F.3d 155, 160-162 (DC Cir. 2002); Opening and Reply Briefs of Sierra Club in Sierra Club v. EPA, DC Cir. 01-1070, at Part I; Earthjustice Comments dated April 26, 1999, addressing EPA's proposal entitled “Extension of Attainment Dates for Downwind Transport Area.” 64 Fed. Reg. 14441 (March 25, 1999); Transcript of Oral Argument in Sierra Club v. EPA, DC Cir. 01-1070 (February 4, 2002).

Response 2: EPA has responded to the contentions regarding the legality of EPA's attainment date extension policy in its responses to comments on the May 9, 2001, proposed rulemaking. As to the assertion that the classification of the Baton Rouge area is “severe” and not “serious,” EPA, prior to the Court-ordered rulemaking published on June 24, 2002, had issued no final rulemaking determining that the Baton Rouge area had not attained the standard by November 1999. Therefore, the Baton Rouge area was not reclassified to “severe.” Moreover, since EPA is today issuing a final attainment date extension and withdrawing its June 24, 2002, determination prior to that determination taking effect, the Baton Rouge area remains classified as a serious area. EPA incorporates its responses to the comments contained in its briefs in the cases cited above.

Comment 3: One commenter argues that the DC Circuit has decided adversely to the attainment date extension, and that similar cases are pending before the Seventh Circuit and before the Fifth Circuit, which is considering this issue in the Sierra Club v. EPA, (No. 01-60537), argued September 4, 2002. EPA should await the outcomes of those cases. The fact that the Louisiana SIP provides for RACM and ROPP does not fix the proposed rules shortfalls. The area should still be reclassified.

Response 3: While the DC Circuit has issued a decision concerning Washington, DC, EPA nevertheless believes that its approach is justified and is currently continuing to litigate the pertinent legal issues in two other Circuits. The Seventh Circuit has yet to rule on the attainment date extension issue with regard to the St. Louis area, and the Fifth Circuit, which would have jurisdiction to review EPA's rulemaking regarding Baton Rouge, has yet to rule on the attainment date extension issue in the context of Beaumont, Texas. When these Circuits issue their decisions in these cases, EPA will reevaluate its position with respect to Baton Rouge.

Comment 4: Commenters claim that on two occasions—on separate amendments offered by Senator Kasten in 1990 and Senator Levin in 1994, Congress rejected amendments to the Clean Air Act providing for attainment date extensions.

Response 4: Neither amendment cited by commenters corresponds with EPA's attainment date extension policy, and there is no evidence that either was acted upon by Congress. In its prior rulemaking notices and briefs EPA has answered the arguments that the commenters raised on the Kasten amendment. As to the Levin amendment cited by commenters, this bill did not address attainment date extensions, but rather a revision to section 182(h)(1) concerning rural transport areas that was aimed at original classifications. This proposed amendment did not propose attainment date extensions, but rather dealt with areas that made no significant contribution to their own ozone concentrations, and proposed to treat them as rural transport areas. In offering this amendment, Senator Levin expressly noted that EPA was grappling with the issue of other areas, whose air quality is affected by the area's own emissions as well as those from upwind areas. Senator Levin's bill did not address this situation, because he acknowledged EPA's plans “to issue a new policy on ozone transport that will hold areas responsible only for that portion of the ozone problem which they cause.” However, this new policy is expected to only correct another inequity in the act, the fact that downwind areas suffering from significant ozone and other pollution transported from more severely polluted areas have less time to achieve attainment. The change in attainment deadlines will not address the problem of areas inappropriately designated in the first place. 140 Cong. Rec. S10538-05 (August 3, 1994).

Comment 5: Commenters contend that it is too late for Louisiana to apply for a transport extension, and that any application for an extension should be denied on the failure of the state to submit a timely application for an extension and for failure to meet the requirements of the attainment date extension in a timely fashion.

Response 5: EPA disagrees that it is too late to grant Louisiana an attainment date extension. First, Louisiana is not applying for an attainment date extension under section 181(a)(5), but in accordance with EPA's transport-based attainment date extension policy. EPA believes that the area timely applied for an attainment date extension pursuant to EPA's attainment date extension policy and that it has made the requisite showing for an extension based upon transport. In its notice of proposed rulemaking EPA set forth the history of this rulemaking action and also noted that EPA had provided additional time for the area to submit documentation in support of its request for an attainment date extension. 67 FR 50391 (August 2, 2002); 66 FR 23646 (May 9, 2001), 66 FR 38608 (July 25, 2001) (supplemental proposed rule). As EPA noted in its final rulemaking of June 24, 2002 (67 FR 42697), Footnote 3, EPA received no adverse comments on its supplemental proposal to extend Louisiana's transport SIP submission date to December 31, 2002.

Comment 6: Congress foresaw the problem of ozone transport and provided a solution under sections 110 and 126. Louisiana never petitioned EPA under section 126 for a finding that sources in Texas significantly contributed to ozone problems in Baton Rouge.

Response 6: As EPA has noted in prior rulemakings, because a functional understanding of transport was late in coming, the tools envisioned by Congress could not be deployed in time to provide the intended relief. The commenter's contention that EPA should not grant Baton Rouge an attainment date extension because Louisiana should have acted earlier to commence a section 126 petition proceeding to reduce emissions from upwind states ignores the fact that an adequate analysis and allocation of responsibility for transport did not exist in time to support relief by the area's original attainment date. EPA incorporates by reference its responses to the comments contained in its briefs in the cases cited above.

Comment 7: Commenters argue that EPA should not approve the RACM analysis for the Baton Rouge area because it does not meet the requirements of the CAA. They also argue that the State and EPA cannot lawfully limit RACM analyses to only those measures likely to advance attainment dates, nor can they lawfully apply an “intensive and costly effort” test. Opening and Reply Briefs of Sierra Club in Sierra Club v. EPA, DC Cir. 01-1070, at Part II. The commenter adds that even if that were not the case, arguendo, the states and EPA must still consider a reasonable range of potential RACM measures, and to the extent that they reject measures as allegedly not constituting RACM, must offer a reasoned and statutorily permissible explanation for doing so. Another commenter argues that control measures are clearly available. The commenters go on to state that: (1) There are many stationary VOC emissions to work with, and (2) many industries in the nonattainment area are reducing their VOC emissions from stationary sources. Since these facilities are actually making these reductions, the commenter concludes that the SIP argument that VOC reductions at this time are deemed to be technologically infeasible is clearly incorrect. The commenter further states that the LDEQ refers to computer modeling results in the SIP to imply that the requirements of RACM in the CAA can be avoided.

Response 7: Louisiana performed a RACM analysis for potential control of NO X and VOC emission sources not included in the attainment demonstration for the Baton Rouge 1-hour ozone attainment area. Each control measure option was evaluated according to: (1) The State's authority to implement controls; (2) the amount of NO X reductions created by the control measure; (3) the amount of VOC reductions created by the control measure; (4) whether a similar control measure is already being implemented in the SIP; (5) the cost effectiveness of the control; (6) whether SIP credit has already been taken for the measure; and (7) whether the measure can be implemented to advance the attainment date. LDEQ conducted analyses of the reductions available from control of VOC and NO X emissions from on-road and off-road mobile sources, major stationary sources of VOC and NO X , and VOC and NO X area sources.

In our August 2, 2002, proposed approval, EPA referenced the methodology Louisiana employed to analyze transportation control measures (TCM) RACM for mobile sources. Louisiana's analysis is explained in Chapter 5 of the SIP. LDEQ analyzed a broad range of TCMs identified and listed in section 108(f) of the Act for RACM availability. As part of its analysis, LDEQ relied on the most recent and comprehensive TCM evaluation study that exists for the Baton Rouge area and reflects updated attainment year vehicle miles traveled (VMT) and emissions reduction estimates. Based on its analysis, LDEQ included in the SIP an enforceable TCM to implement an advanced transportation management system and a vehicle I/M program. Relative to the total NO X reductions required to demonstrate attainment of the 1-hour ozone NAAQS in the Baton Rouge area, additional NO X reductions from other TCMs in the Baton Rouge area that might be implemented constitute a very small percentage (approximately 1%) of the total reductions required for attainment. Thus, LDEQ concluded, an EPA agrees, that for RACM purposes implementation of additional TCMs would not produce emissions reductions sufficient to the advance the attainment date.

Louisiana also analyzed control options as RACM for major stationary sources of VOC and NO X . Louisiana has implemented Reasonable Available Control Technology (RACT) for major stationary sources of NO X and VOC. As the commenter notes, many industries in the Baton Rouge area are already reducing their VOC emissions from stationary sources to meet the VOC RACT requirements of the Act. The 24% rate-of-progress VOC emissions reductions required under the Act have already been achieved in the Baton Rouge area. Modeling analysis for the Baton Rouge area indicates that a 30% “across the board” reduction in VOC emissions yields less than a 1 ppb decrease in the ozone peak for all three modeled episodes. Based on its analysis, LDEQ concluded that VOC reductions beyond those already in place would not be sufficient to bring the area into attainment sooner than 2005 and were not technologically feasible or cost effective at this time. Furthermore, the modeled attainment demonstration shows that the Baton Rouge area relies upon emissions reductions from outside of the attainment area and from federal rules with implementation dates that will not occur until 2005. LDEQ performed a similar analysis for NO X RACM. EPA has reviewed and agrees with the State's RACM analysis. For further details concerning Louisiana's RACM analysis please refer to the RACM TSD and LDEQ's RACM analysis.

The EPA's approach toward the RACM requirement is grounded in the language of the CAA. Section 172(c)(1) states that a SIP for a nonattainment area must meet the following requirement: “In general.—Such plan provisions shall provide for the implementation of all reasonably available control measures as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology) and shall provide for attainment of the national primary ambient air quality standards .” [Emphasis added.] The EPA interprets this language as tying the RACM requirement to the requirement for attainment of the national primary ambient air quality standard. The CAA provides that the attainment date shall be “as expeditiously as practicable but no later than * * *” the deadlines specified in the CAA. EPA believes that the use of the same terminology in conjunction with the RACM requirement serves the purpose of specifying RACM as the way of expediting attainment of the NAAQS in advance of the deadline specified in the CAA. As stated in the “General Preamble” (57 FR 13498 at 13560, April 16, 1992), “The EPA interprets this requirement to impose a duty on all nonattainment areas to consider all available control measures and to adopt and implement such measures as are reasonably available for implementation in the area as components of the area's attainment demonstration.” [Emphasis added.] In other words, because of the construction of the RACM language in the CAA, EPA does not view the RACM requirement as separate from the attainment demonstration requirement. Therefore, EPA believes that the CAA supports its interpretation that measures are not RACM if they do not advance the attainment date. In addition, EPA believes that it would not be reasonable to require implementation of measures that would not in fact advance attainment (see 57 FR 13560). EPA has historically taken this interpretation and consistently implemented it through guidance since 1979 (see 44 FR 20372, 20375, April 4, 1979).

The term “reasonably available control measure” is not actually defined in the CAA. Therefore, the EPA interpretation that potential measures are not to be RACM if they require an intensive and costly effort for numerous small area sources is based on the common sense meaning of the phrase, “reasonably available.” A measure that is reasonably available is one that is technologically and economically feasible and that can be readily implemented. Ready implementation also includes consideration of whether emissions from small sources are relatively small and whether the administrative burden, to the States and regulated entities, of controlling such sources was likely to be considerable. As stated in the General Preamble, EPA believes that States can reject potential measures based on local conditions including cost. 57 FR 13561.

When EPA presented this statutory argument in support of its RACM policy to the U.S. Court of Appeals for the DC Circuit in defense of its approval of the Washington DC ozone SIP, the DC Circuit found reasonable EPA's interpretation that measures must advance attainment to be RACM. Sierra Club v. EPA, 294 F.3d 155, 162 (DC Cir. 2002). Specifically, the Court found that:

Also, LDEQ's analysis indicates that the development of rules for a large number of very different source categories of small sources for which little control information may exist will likely take much longer than development of rules for source categories for which control information exists or that comprise a smaller number of larger sources. It is less likely that the emission reductions from such additional rules in the nonattainment area would advance the attainment date more than emission reductions achieved from controls on major stationary sources, mobile sources, and federal rules in the Baton Rouge area. Thus, it is of greater value and more expeditious for the State to expend the administrative effort and costs to pursue larger reductions from a smaller number of sources.

When EPA presented this statutory argument in support of its RACM policy to the DC Circuit in defense of its approval of the Washington DC ozone SIP, the DC Circuit also found reasonable EPA's interpretation that it could consider costs in a RACM analysis and that measures may be rejected if they would require an intensive and costly effort for regulation of many small sources. Sierra Club v. EPA, 294 F.3d at 162, 163.

Finally, the SIP does not, as the commenter claims, imply that the requirements of RACM in the CAA can be avoided in the nonattainment area based on the attainment modeling. The SIP merely notes that the attainment modeling along with the proposed NO X reductions from major stationary sources, mobile sources and federal rules are shown to be sufficient for the Baton Rouge area to meet the NAAQS for ozone by 2005, and that there are no additional RACM to advance the attainment date. We do not consider measures as RACM for the Baton Rouge area if they do not advance the attainment date, as recently upheld by the DC Circuit Court. We are still requiring the State to demonstrate that all local measures that are RACM are implemented as expeditiously as practicable.

Comment 8: A commenter states that EPA cannot lawfully approve SIPs which lack rate of progress reductions for the full period by the CAA—which includes not just the reductions required during the period up to November 15, 1999, but also 9% VOC reductions from November 15, 1999 to November 15, 2002, and another 9% reductions from November 15, 2002 to November 15, 2005. Another commenter states that the SIP must include reductions until the area achieves its attainment date. The commenter concludes that since the attainment date is extended, the reasonable further progress demonstration required in Section 182(c)(2)(B) must be included in any approvable SIP. A commenter asserts that the CAA does not allow for the revisions to the 15% ROPP, the 1990 Base Year Emission Inventory, nor the Post-1996 ROPP because the CAA does not allow ROPP reductions to occur outside the nonattainment area. Additionally, the commenter states that in order for Louisiana to take credit for the emission reductions outside the nonattainment area the State must prove that the reductions would result in actual reductions in ozone within the attainment area. The commenter concludes that LDEQ did not specifically model emissions reductions from Trunkline and therefore should not be allowed to include these credits in its ROPP. Finally, the commenter argues that the reductions have already occurred and since the area remains in nonattainment after these reductions then the reductions obviously are not going to solve the ozone problem and can not be considered progress. The commenter also incorporates by reference comments submitted by LEAN on EPA's proposed approval of Louisiana's contingency measures dated May 20, 2002.

Response 8: EPA's guidance did not interpret the period of time after granting the attainment date extension based on transport as requiring additional rate of progress increments from the downwind area, since we determined that the reason the area had not attained was due to upwind transport. Consistent with the purposes of the attainment date extension policy, EPA believes it would be inequitable to require areas in which attainment is affected by transport to meet additional local ROPP requirements. EPA believes it would be unreasonable to require the downwind area into such progress requirement reductions from local sources, when the combination of local reductions with upwind area source emission reductions is what will bring the area into attainment. In any event, to the extent that it should be determined otherwise, and that any ROPP required should be imposed on the downwind area, this would not be required until EPA grants the attainment date extension and provides the area with a later attainment date. Since the requirement was not previously due, fulfilling the requirement, if any is deemed to exist, is not a condition of receiving the attainment date extension. Responses to Louisiana's contingency measures are being addressed in the Federal Register final action for that component of the SIP.

In reference to the comment concerning the modeling of the emission reductions from Trunkline, the commenter is referred to the above mentioned December 29, 1997, EPA guidance document. Pages 5 and 6 of the guidance document discuss EPA's guidance on ROPP. EPA's guidance “* * * only requires that an area in nonattainment for the 1-hour NAAQS should be allowed to take credit for emissions reductions obtained from sources outside the designated nonattainment area for the post-1999 ROP requirement as long as the sources are no farther than 100 km (for VOC sources) or 200 km (for NO X sources) away from the nonattainment area.” The guidance does not indicate that modeling of ROPP emissions should be conducted for EPA to allow the use of ROPP emissions within 100km (VOC) and 200km (NO X ) of the nonattainment area. Trunkline's emissions changes are included in the overall modeling analysis, and the results show that emission reductions are necessary in the surrounding attainment parishes for the Baton Rouge nonattainment area to demonstrate attainment. Domain-wide modeling, rather than source specific modeling of facility emission changes such as Trunkline's, is used to tell us what level of reductions are needed for the nonattainment area to demonstrate attainment.

Comment 9: One commenter asserts that EPA cannot lawfully approve SIPs that lack contingency measures. The commenter further states that as shown in the commenter's Sierra Club v. EPA briefs, contingency measures must be additional measures that activate in the event of a contingency, not surplus reductions from measures being implemented anyway ( e.g. , as part of the attainment rate-of-progress SIP). Sierra Club, 294 F.3d at 164; Opening and Reply Briefs of Sierra Club in Sierra Club v. EPA, DC Cir. 01-1070, at Part IV.

Response 9: EPA has found the contingency measures in the SIP to be surplus, permanent and federally enforceable. EPA is approving these contingency measures in a separate action which published in the Federal Register on September 26, 2002. See EPA's final action on the contingency measures for responses to related comments.

Comment 10: A commenter states that EPA should not withdraw its June 24, 2002, rulemaking determining that Baton Rouge was in nonattainment and reclassifying it from “serious” to “severe” because to do so would be against both the plain language of the CAA and Congressional intent.

Response 10: EPA is withdrawing its June 24, 2002, rulemaking relating to the Baton Rouge reclassification based on Louisiana fulfilling EPA's attainment date extension policy and EPA's approval of their attainment demonstration and transport SIP. See related responses on EPA's attainment date extension policy above.

Comment 11: The commenter indicates that it is a poor idea to adopt contingency measures that require emission reductions outside the nonattainment area.

Response 11: The CAA gives the states considerable latitude and discretion in adopting state implementation plans. The CAA also recognizes that addressing ozone nonattainment within a given area may involve regulation of emissions from sources outside of the nonattainment area. See CAA sections concerning international pollution (42 U.S.C. 7415), interstate transport commissions (42 U.S.C. 7506a), and interstate pollution abatement (the so-called “good neighbor” section, 42 U.S.C. 7426). Since a state may petition the EPA to regulate sources beyond the state's boundaries in order to address a nonattainment area within the state, the state is certainly free to regulate precursor emissions outside the nonattainment area, but still within the state, that impact the nonattainment area. Furthermore, LDEQ did conduct a modeling sensitivity run (Run LA-1) to evaluate the effectiveness of a 30% NO X reduction in low-level and elevated sources in Grid D. This modeling sensitivity run demonstrated that additional reduction in the simulated ozone concentrations and 1-hour ozone exceedance exposure within the 5 parish nonattainment area is obtained from NO X emission reductions within Grid D from parishes that are outside the nonattainment area.

Comment 12: One commenter suggests that the Classification and Regression Tree (CART) analysis does not demonstrate that there is a significant problem with ozone transport. Another commenter indicated that the state used an insufficient amount of data (5 years vs. 20 years) in determining the ranking system to calculate expected ozone exceedances (ExEx), leading to uncertainty about the reliability of the conclusions reached based on these data.

Response 12: The CART analysis was conducted to support the episode selection portion of the Baton Rouge local modeling analysis. The CART analysis that was done for the local modeling analysis was not specifically designed to identify regional transport conditions. In addition to a transport analysis, the attainment demonstration must address whether or not local measures are needed for attainment. If the attainment demonstration indicates that local control measures are required, the demonstration must quantify the level of the needed local emission reductions. For the local portion of the attainment demonstration, the episodes modeled were to be primarily “home-grown,” rather than dominated by transport. Thus, the meteorological and air quality data used in the CART analysis to characterize potential modeling episodes were all local Baton Rouge data. (The only non-Baton Rouge data was the upper air data obtained from near-by Slidell, Louisiana, which has the closest radar profiler.) This particular CART analysis did not consider other parameters that may have been more indicative of regional transport ( e.g. surface winds at Calcasieu, Lafayette, etc.).

Although the use of local Baton Rouge data alone is not sufficient to fully characterize regional transport conditions in Louisiana and neighboring states, the CART analysis approach was a component relied upon, to demonstrate the frequency of transport. Meteorological and air quality data for a five-year period (1996-2000) were also characterized and analyzed. The results indicated that 7 percent of the Baton Rouge exceedance days ( i.e. , 2 out of 28 exceedance days) were potentially associated with transport of ozone and/or precursor pollutants from the Houston area. EPA believes these data demonstrate a sufficient impact from Houston to satisfy the criteria of our attainment date extension policy. Another CART analyses of frequently occurring meteorological conditions during ozone exceedances for a 10 year period (1989-1998) indicated that a “Gulf-High” regime was associated with 30% of the Baton Rouge exceedance days during that period. A “Gulf-High” existed in the modeled August 19, 1993 episode. This modeling demonstrated that transport of emissions from the Houston area to the Baton Rouge area. The impact from the Houston area upon the Baton Rouge area's ozone concentration was 2-6 ppb.

We disagree that the State used insufficient data in determining the ranking system. The CART analysis approach to characterizing episodes and ranking them on the basis of severity is an alternate approach that has been accepted by EPA for other 1-hour ozone SIP modeling applications. These include Atlanta, Georgia, Birmingham, Alabama, and Louisville, Kentucky. The approach provided in EPA guidance (Cox and Chu) uses meteorological data of a twenty-year record. Under the same meteorological conditions, expected ozone concentrations would possibly be very different if the magnitude or ratios of the VOC and NO X emissions are different. Over the last 20 years the effect of Federal and state regulations have resulted in changes in ratios/quantities of VOC and NO X anthropogenic emissions in the Baton Rouge area. Thus, the CART approach applied in the Baton Rouge SIP modeling analysis takes into account only the most recent 5 years of data. This approach is followed in an attempt to avoid potential complications inherent in assessing correlations between meteorological conditions and the observed concentrations when a major influencing variable ( i.e. emissions inventory) has likely changed over a longer period, such as twenty years.

Comment 13: The “gulf-high” conditions associated with transport do not demonstrate that the Baton Rouge area is suffering from transport from the Houston-Galveston area.

Response 13: We disagree. The August 19, 1993, episode was a “Gulf-High” regime day, and the modeling results demonstrated that the Houston area significantly contributed to the Baton Rouge area. This modeling showed an impact of 2-6 ppb on ozone concentrations in the Baton Rouge area. CART analysis approach also characterized this episode as “Gulf-High” regime. We agree that the relative positioning of the center of the high pressure zone in the Gulf of Mexico as well as the strength of circulation winds determine whether or not transport from the Houston area occurs and the level of impact of the transported emissions when transport occurs. Because of these considerations,transport from Houston to Baton Rouge does not always occur under all conditions labeled “gulf-high”.

Even so, the important point is that on many exceedance days, the Baton Rouge and surrounding areas have experienced meteorological conditions under which transport from Houston could have contributed to the exceedance. Some 30% of the exceedances in a ten-year period, and some 7% of the exceedances in a 5-year period, were associated with “Gulf-High” days. It is reasonable to conclude that some appreciable portion of the gulf-high days were conducive to transport from Houston.

Similarly, other meteorological regimes may be conducive to transport from Houston. These include “coastal return” days and “continental high” days as discussed further in the Technical Support Document. These meteorological regimes may also allow for transport from Houston. Because they are common regimes, it is reasonable to assume that some occurred on exceedance days. Further, it is reasonable to assume that on some of those days, transport from Houston occurred.

This information concerning the meteorological regimes must be considered together with modeling that specifically identifies transport from Houston, as discussed elsewhere.

Accordingly, although the data is insufficient to quantify specifically the number of exceedance days with meteorological regimes conducive to transport from Houston, and the number of days in which transport from Houston actually occurred, EPA believes that the data is sufficient to support a conclusion that transport from Houston occurred frequently enough, since the Baton Rouge area is only allowed 3 exceedances in a 3-year period, to adversely affect the area's ability to attain. Thus for Baton Rouge to attain, controls in Houston area, as well as in Louisiana, are necessary. Louisiana has demonstrated that during some Baton Rouge area exceedances, ozone levels are influenced by emissions from the Houston area, and that the Houston area emissions affect the Baton Rouge area's ability to meet attainment of the 1-hour ozone standard by November 15, 1999.

Comment 14: Modeling used by the State (based on August 19, 1993) does not demonstrate that the Baton Rouge area is suffering from ozone transport. Another commenter indicated that EPA's own data do not show a significant effect on Baton Rouge from Houston's air pollution.

Response 14: We disagree. The August 19, 1993, modeling results demonstrated that the Houston area significantly contributed to the Baton Rouge area. This modeling showed an impact of 2-6 ppb on ozone concentrations in the Baton Rouge area when the Houston area emissions are zeroed out. A “Gulf-High” existed during the modeled August 19, 1993 episode. The August 1993 episode occurred during the Gulf of Mexico Air Quality Study (GMAQS) field program and the modeling of that episode benefitted from intensive, enhanced ground level, upper-air, and aircraft measurements. The episode consisted of a ramp up day on August 18th and a primary episode day on August 19th. Due to the influence of the initial and boundary conditions, EPA guidance does not recommend the State to take the ramp-up day ( i.e. , August 18th) into consideration in developing a control strategy. The observed regional conditions, including the additional meteorology measurements from the field study, during this period were found to be conducive for potential transport of pollutants from the Houston area to the Baton Rouge 5-parish nonattainment area. CART analyses indicate that transport conditions have occurred historically and one episode (the August 19, 1993) has been modeled to demonstrate transport.

In addition, a modeling run was conducted for a period in 1997 (8/30-31) in which not only Houston area emissions, but also Beaumont Port-Arthur emissions were zeroed out. This run indicated impacts from the zero-out in a north-northeasterly direction from southeast Texas, with a 10 ppb impact in Little Rock which is approximately twice the distance from southeast Texas to Baton Rouge. The run lends support to the conclusion that Houston contributes to exceedances in the Baton Rouge area. A relatively small shift in the direction of the winds during the period modeled may have resulted in a bigger impact in the Baton Rouge area, which supports the conclusion that some of the exceedances in the Baton Rouge area experienced contributions from Houston. The commenter refers to EPA's “own data” in the proposed notice where it states that 7% of the ozone exceedances in a five year period were associated with “gulf-high” met regime with high level westerly winds. This statement was derived from the Baton Rouge SIP's record. It is only one component of the information that EPA has looked at in determining that the Baton Rouge area is impacted by transport for Houston area emissions. EPA has made a judgement that the frequency of occurrence for transport of Houston's air pollution is significant enough to be of concern in Baton Rouge. Baton Rouge's ability to attain is affected by the impact on it from the Houston area, as documented above. For further information, see the Technical Support Document and the State's submittals.

Comment 15: Table 1-3 of Louisiana's SIP shows that the model drastically over-predicts the amount of ozone that was actually formed on August 18 and 19, 1993, in the Baton Rouge area based upon the “Unpaired accuracy of the peak concentration” metric.

Response 15: The model does not drastically over-predict taking into account all of the metrics and graphics. Unpaired accuracy of the peak concentration is just one of the metrics used to evaluate model performance and the August 18 day is the only day outside the EPA guidance value of ±20 percent. The August 18 day was the model ramp-up day and the August 19 day was the primary episode day. As previously noted, due to the influence of the initial and boundary conditions, EPA guidance does not recommend the State to take the ramp-up day ( i.e. , August 18th) into consideration in developing a control strategy. The August 19 day is within the EPA guidance value for this metric. This metric is a domain wide peak and the model may be predicting for the August 18 day, a peak at a location that did not have a monitor. Another metric evaluated is the Normalized Bias, which measures the model's ability to replicate observed patterns during the times of day when available monitoring and modeled data are most likely to represent similar spatial scales. The EPA guidance value for Normalized Bias is ±15 percent and the values for the August 18 and 19 days are −1.9% and −0.2%. This indicates that the model is doing a very good job in predicting concentrations similar to the observed monitored concentrations. For further analyses that support approval of this episode (without the zero out run), EPA utilized the Technical Support Document (June 1996) and submittals from LDEQ for the previous attainment demonstration SIP. EPA relied upon the complete package of analyses submitted by LDEQ in approving the Baton Rouge SIP.

Comment 16: One commenter asserts that the model over predicts ozone and that this error could be due to errors in the models input that also produce a result of transport from Houston to Baton Rouge. The commenter then indicates that this is only one possible interpretation for the over-prediction of the modeled ozone values.

Response 16: The August 1993 episode occurred during the Gulf of Mexico Air Quality Study (GMAQS) field program and the modeling of that episode benefitted from intensive, enhanced ground level, upper-air, and aircraft measurements. The observed regional conditions during this period were found to be conducive for potential transport of pollutants from the Houston area to the Baton Rouge 5-parish nonattainment area. It occurred in the “Gulf-High” regime, and the results demonstrate that emissions from the Houston area are to contributing significantly to the Baton Rouge area exceedances. The modeling runs removing all of the anthropogenic emissions in the Houston area showed significant changes in ozone concentration in the Baton Rouge area. The meteorological model showed that some air masses were coming from the Houston area. Therefore the meteorological modeling indicated that some air masses, and their pollution concentrations, were transported from the Houston area to the Baton Rouge area during this 1993 episode. The fact that the 1993 modeling is predicted ozone concentrations in the domain that are higher than the monitored values does not lead to a conclusion that there is an error in the modeling that would result in an erroneous determination in the magnitude of the impact of transport from Houston to Baton Rouge. Where there are monitors, the modeling has predicted comparable ozone concentrations for the overall Grid D domain. The modeling indicated ozone concentrations higher than values monitored in the Grid D domain in grid cells where monitors did not exist. It is not unusual for modeling to generate higher values in grid cells without monitors, since there are many more grid cells without corresponding ozone monitored values than there are grid cells with monitored values. This is an artifact of modeling and does not, in any way, mean that the transport modeling over-predicts the impacts.

Comment 17: One commenter indicates that the SIP erroneously indicates that the modeling results indicate that the Houston area has an impact on the Baton Rouge design value as high as 6 parts per billion (ppb). The expected impact on the design value can only be the average impact contributing to transport not the maximum value.

Another commenter said that even subtracting the State's estimate that between 2 and 6 parts per billion of ozone is being transported from Houston, the Baton Rouge area is still in nonattainment and therefore not sufficiently “affected by transport” to qualify for an extension. This commenter then went on to say that Louisiana has indicated that if the 2-6 ppb were taken into account that Baton Rouge would be in attainment, which is not correct.

Response 17: The 2-6 ppb is a range of potential influence that was estimated based on one set of meteorological conditions. The effect of the 2-6 ppb from transport indicated by the August 19, 1993, modeling impacts upon the current 1-hour design value is difficult, if not impossible, to infer. To use the average impact, as the commenter indicates, or to analyze the exact impact of transport of Houston area emissions/ozone on the Baton Rouge design value would be misleading and inappropriate. The ozone design value is driven by the 4th high value recorded at a monitor within a 3 year period. The monitored values are impacted by transport some of the time, so it is safe to conclude that the monitored values that drive the design value also are affected by transport some of the time (Please see other related responses to comments for more details on the transport discussion). To this extent the design value is impacted. The commenter is correct that the Baton Rouge area showed it needed additional local NO X emission reductions to attain; therefore, even eliminating the transported emissions from Texas would not bring the Baton Rouge area into attainment. That the Baton Rouge area needs local emission reductions to attain, does not mean that the area is not impacted by transport from Houston or that the area does not satisfy the criteria of our attainment date extension policy.

Comment 18: Louisiana shouldn't be using the BEIS2 data to set biogenic emissions. These data are known to be incorrect. Once the BEIS2 data are used the computer model will always give the result that controlling NO X will be preferable to controlling hydrocarbon emissions. This is an artifact of BEIS2 data and is not an accurate reflection of reality. The commenter included references to two reports and indicated that BEIS2 is inaccurate and should have not been used for the attainment demonstration. The commenter then requested that a new attainment demonstration be made using more accurate biogenics data.

Response 18: BEIS2 is the EPA-approved method for estimating biogenic emissions. Louisiana followed EPA's guidelines while applying BEIS2. At the time that LDEQ conducted the modeling, the BEIS-2 model was (and remains) the EPA-recommended model for developing biogenic emission estimates for 1-hour attainment demonstration SIP modeling. The report Biogenic Sources Preferred Methods, May 1996, indicates that BEIS-2 is the model recommended to be used for estimating biogenic emissions at the time the emissions were being developed for the Baton Rouge SIP modeling. Although EPA is currently developing a third version of the model (BEIS-3), it has not been given to the public for use in formal SIP modeling applications. However, in recent discussions with EPA developers, all indications are that the magnitude of the emissions will likely change very little with BEIS-3 compared to the large changes encountered between BEIS and BEIS-2. Small changes in the magnitude of biogenic emission estimates would not significantly change the overall strategy contained in the Baton Rouge area ozone SIP. BEIS-2 was also used to support the recent 1-hour ozone attainment demonstration SIP modeling for Atlanta, Georgia and Birmingham, Alabama. The two reports that the commenter lists seem to indicate some potential issues for refinement in the state-of-science of estimating biogenic emissions. The state-of-the-science continues to improve in multiple areas of ozone modeling, and the regulatory authorities have to use the best tools at the time to perform ozone modeling. It is unrealistic to require the use of modeling tools ( i.e. , BEIS3) that become available after the modeling was initially conducted and formally submitted for approval.

Comment 19: On commenter states that Louisiana relies on computer modeling to determine that only NO X controls, and not stationary VOC source controls, will advance attainment in the Baton Rouge area. This position is a change from only six years ago when EPA approved Louisiana's SIP that relied on computer modeling results to avoid the very NO X control requirements of Section 182(c), that are now being touted as the only solution. While computer modeling can be used for general conclusions on potential strategies, it should not be relied upon to release industries with controllable emissions from the requirements of 172(c)1.

Response 19: EPA disagrees with the commenter's assertion that LDEQ used computer modeling to release industries from the requirements of section 172(c)(1) of the Act. The state-of-the-science of ozone modeling, both the modeling tools and the understanding of how ozone is generated, continues to evolve. Louisiana's current SIP control strategy is a direct result of these types of improvements. Louisiana conducted numerous sensitivity runs and they showed that additional VOC controls were not very beneficial and that NO X controls were beneficial in reducing ozone concentrations in the Baton Rouge area. Computer modeling is routinely utilized to determine if control strategies are beneficial and also to rank control strategies based on resulting decreases in ozone.

When EPA granted Louisiana NO X exemptions under section 182(f) of the Act on January 26, 1996 (61 FR 2438), EPA reserved the right to reverse the approval of the exemptions if subsequent modeling data demonstrated an ozone attainment benefit from NO X emission controls. Photochemical grid modeling recently conducted for the Baton Rouge area SIP indicates control of NO X sources will help the area attain the ozone NAAQS. Louisiana therefore requested that the EPA rescind the NO X exemption based on this new modeling on September 24, 2001. In our proposed approval of the rescission of the NO X waiver (May 7, 2002, 67 FR 30638), we stated that we believed that the State had adequately demonstrated that additional NO X reductions would contribute to attainment of ozone NAAQS. Louisiana is not the only state that has requested that the EPA rescind its NO X waiver based on updated photochemical grid modeling information. Seven years elapsed between the LDEQ's previous modeling demonstration that additional NO X reductions would not contribute to area attainment, and the most recent modeling events demonstrating that additional NO X reductions would help the Baton Rouge area attain. As noted above, pollution control technology, including air modeling, is a dynamic and evolving field. The model used by LDEQ to support its request for approval of the NO X waiver in 1996 was Urban Airshed Model (UAM) IV, which was an EPA-approved photochemical grid model. The model used by LDEQ to support its recent request for rescission of the NO X waiver was UAM V, a more recently EPA-approved Photochemical Grid Model. This represents a significant refinement in modeling technology.

Adverse comments on our proposed approval for the Baton Rouge SIP were also received from LAGen. The commenter supports EPA's proposal to approve the attainment demonstration, extend the attainment date and withdraw the reclassification, however, they take exception to the proposed Control Strategy Element in the SIP's Section 4.2.1., “Permitting of NO X Sources.” The commenter contends that these SIP revisions could effectively and unnecessarily result in the imposition of the equivalent of a nonattainment rule in an attainment area without first promulgating a rule to establish and implement the new requirements. The commenter also provides detailed comments concerning the SIP revisions. The following are a summary of those detailed comments and EPA's responses.

Comment 20: The commenter requests that EPA not approve Section 4.2.1 of the SIP revisions, which describes the permitting of sources of NO X in Louisiana. Although the commenter fully supports Louisiana's newly promulgated NO X RACT regulations, the commenter contends that Section 4.2.1 results in the imposition of nonattainment rules in an attainment area without the required opportunity for notice and comment rulemaking. The commenter argues that EPA's rules applicable to approval of SIP revisions requires public notice of such provisions and prohibits EPA from approving components of SIP revisions that were neither noticed to the public nor prepared in accordance with state law. The commenter contends that Section 4.2.1 constitutes an unlawful delegation of legislative authority under state law because LDEQ did not provide proper opportunity for public notice and comment of this section of the SIP. The commenter also contends that approval of Section 4.2.1 would impose additional and significant requirements beyond those currently required by state law and that EPA's approval of this provision is an “action concerning regulations that significantly affect energy supply, distribution or use.” The commenter also claims that EPA's approval of Section 4.2.1 constitutes a “significant regulatory action” and an “unfunded mandate.” Therefore, according to the commenter, EPA's approval of Section 4.2.1 requires review by the Office of Management and Budget.

Response 20: EPA disagrees with the commenter's characterization of Section 4.2.1 of the SIP. As noted in its plain language, Section 4.2.1 is not intended as new policy or guidance. We disagree with the commenter's interpretation that Section 4.2.1 of Louisiana's SIP imposes nonattainment rules in an attainment area. Section 4.2.1 provides the State's acknowledgment of the requirements of sections 110(j) and 165(a)(3) of the Act, which prohibit the permitting of emissions from the construction or operation of sources that will cause, or contribute to, air pollution in excess of any national ambient air quality standard in any air quality control region, or any other applicable emission standard or standard of performance under the Act. Thus, Section 4.2.1 is a recitation of existing requirements under state and Federal law. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. This action is not a “significant regulatory action,” nor is it an “unfunded mandate.” Therefore EPA's approval of the SIP, including Section 4.2.1, 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).

EPA also disagrees with the commenter regarding public participation. LDEQ provided notice of the SIP revisions in several area newspapers and in the Louisiana Register on October 20, 2001 (Louisiana Register, Vol. 27, No. 10). LDEQ also conducted a public hearing November 26, 2001, at which a representative from LAGen was present. Any changes made to section 4.2.1 before LDEQ submitted the SIP to EPA for approval were made in response to comments LDEQ received on its proposed SIP revisions and do not add any new requirements under state or federal law. EPA believes LDEQ properly followed the requirements under state law and under 40 CFR Part 51 in promulgating these SIP revisions. For additional information about the permitting of NO X sources, please see EPA's recent approval of Louisiana's NO X RACT regulations and revisions to Louisiana's nonattainment New Source Review program. For these reasons, EPA is approving the SIP as submitted.

Comment 21: LAGen indicated that it is very difficult to evaluate the UAM-V modeling in regard to emissions inputs rendering the regulated community without direct access to the inputs on a facility by facility basis prior to submission of the SIP revisions. Louisiana Generating indicated that they were not previously able to review emission values assigned to individual facilities to evaluate the inputs. Since the submission of the SIP Revisions, LAGen has been informed that the inputs, or base case inventory, included approximately 4,000 tons per year (TPY) of NO X emissions that did not exist during the base case year and much of which may not be available for use as emission reduction credits. In addition, the model inputs included an inflated value of approximately 6,600 TPY of VOC emissions and probably the majority of these will not be creditable. The use of inflated emissions values in the modeling raises the question of whether the results support all of the control strategies and especially permitting.

In another section of its comment letter, LAGen indicated that the base year inventory used as emissions data inputs for modeling of the Baton Rouge area is believed to be considerably inflated (4,000 TPY of NO X and 6,600 TPY of VOC) through inclusion of emissions that were eliminated in years before the modeling took place. LAGen claims that the year chosen for inclusion of facility by facility emissions data resulted in inflated emissions values. Therefore, the results of modeling exercises are overestimated and the Control Strategies chosen are based on inflated episode values rendering portions of the SIP revisions more stringent than justified by the data. As submitted to EPA, the State's Attainment Plan/Transport SIP unnecessarily punishes primarily undeveloped parishes in the Region of Influence by limiting their economic development options through the requirement to provide offsets.

Response 21: We disagree. The State provided public notice and a hearing to receive comments on all aspects of the attainment demonstration SIP modeling, including the inventories and approaches used to develop them. As required, the State must make all of these materials available to the public upon request. Moreover, all modeling inputs as well as modeling processes used in the State attainment demonstration SIP were presented and discussed at the monthly Technical Oversight Committee meetings, which included representatives from private industries, local citizens, State, EPA, etc. EPA understands that the State has made all model inputs available to the public for review and comment. In addition, the State instructed it's modeling contractor to provide the public access to this information.

Comment 22: LAGen indicated that the inputs for the modeling include overestimated NO X emissions and VOC emissions. LaGen further stated that these “excess” emissions will not be available for use as offsets and should not have been included in the model.

Response 22: LAGen did not provide any explanation of how the values provided were derived and what is the source of these “inflated” emissions. The basecase emission inventory inputs, as well as the meteorological inputs, were utilized to replicate historical ozone exceedance episodes. The State used emission inventories that were acquired from the LDEQ annual emission inventory submittal from the industrial facilities themselves, and various local, state, and federal agencies. As required, the State has made all these information available to the public upon request. LDEQ also utilized other sources for the SIP modeling that were developed with EPA approved emission modeling tools or techniques. Once the base case UAM-V modeling were completed, these emission inventories were then projected to a future year for the development of an emission control strategy. As outlined by EPA guidance and procedures, LDEQ's projected emission inventories accounted for future growth and control. Specifically, LDEQ included the change in emissions due to emission offsets, emission controls, emission growth, and emission reduction credits. While the claimed 4,000 TPY of NO X is a sizeable amount of emissions, it is only equivalent to approximately 2% of the Grid D domain total NO X emissions on a daily basis. Sensitivity modeling runs indicated that a decrease in VOC emissions of 30% domain wide, would only result in a few ppb change. The commenter indicated that the basecase inventory was inflated by 6,600 TPY of VOC, which corresponds to approximately 1% of the Grid D domain. Therefore, if excess emissions at the levels the commenter indicated were included in this modeling, the resulting change in the domain's ozone values would likely be in the “noise” of the model.

Comment 23: LAGen also indicated that the inflated emission inputs resulted in overestimation in the model, which resulted in more NO X controls than are actually needed and, therefore, LDEQ should not need to obtain offsets for “new” sources in the surrounding area.

Response 23: The commenter's conclusion is based upon the underlying premise that the model overestimates emissions, and results in an over prediction of ozone concentrations. Furthermore, the commenter's remark that the year chosen for facility emissions in the basecase modeling is not representative of today's emission levels is inaccurate. The purpose of the basecase modeling is to use an emission inventory that reflects the facility's emissions during the ozone episode being modeled (1997 and 1999), not current day (2002) emission levels. To use 2002 emission levels would not be appropriate for 1997 and 1999 episodes. The model inputs represent the best estimates that reflect actual emissions, taking into account requirements for “banked” reductions potentially available for future offsets. The modeled results demonstrated attainment for two of the three episodes and the other episode used weight of evidence. For most of the days modeled in the three episodes the modeling seemed to under predict at paired monitor vs. observed values. The “Average Accuracy of the Peak” the “Normalized Bias” metrics seem to indicate that the model was either less that 3% over or was under predicting within the Grid D domain for most of the modeled days of the three episodes (20 out of 25 days for the Average Accuracy of the Peak and 19 out of 25 days for the Normalized Bias). Both of these metrics compare monitored values with modeled values to evaluate the model performance. Model runs conducted by LDEQ clearly demonstrated the impact of large increases in “new” emissions in the area of influence. Such increases, without a one-to-one offset, clearly impacted the attainment demonstration. Furthermore, the state is free to adopt a more stringent control strategy if the state wishes (Section 116 of the CAA).

EPA is taking the following actions on the state submittals addressed by this final rule:

1. EPA is approving the ground-level 1-hour ozone attainment demonstration SIP for the Baton Rouge, Louisiana, ozone nonattainment area.

2. EPA is approving the State's Transport Demonstration and is granting the State's request for extension, and extending the date for attaining the 1-hour ozone standard to November 15, 2005, while retaining the area's current classification as a serious ozone nonattainment area.

3. EPA is approving the 2005 on-road MVEBs for Louisiana. EPA is also approving Louisiana's enforceable commitment to revise its 2005 MVEBs based on MOBILE6 within two years of its release. No conformity determinations will be made during the second year following the release of MOBILE6 unless and until the MVEBs have been recalculated using MOBILE6 and approved by EPA.

4. EPA is approving an enforceable TCM.

5. EPA is approving the revisions to the 1990 base year emissions inventory, the 15% ROPP, and the Post-1996 ROPP.

6. EPA finds that the Baton Rouge area meets the requirements pertaining to RACM under the Act.

7. EPA is approving Louisiana's enforceable commitment for a mid-course review.

8. EPA is withdrawing our June 24, 2002, rulemaking action entitled “Determination of Nonattainment as of November 15, 1999, and Reclassification.” For the reasons stated above in the “Background” portion of this notice, EPA is making this final action immediately effective.

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

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. 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 CAA. 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 CAA. 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 2, 2002. 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).)

EPA Region V is publishing this direct final notice of deletion of a portion of the Department of Energy Mound Superfund Site (Mound Site), from the NPL.

EPA identifies sites that appear to present a significant risk to public health or the environment and maintains the NPL as the list of those sites. As described in section 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions if conditions at a deleted site warrant such action.

Because EPA considers this action to be non-controversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective December 2, 2002 unless EPA receives adverse comments by November 1, 2002 on this document. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses Parcel 4 of the DOE Mound Superfund Site and demonstrates how a portion of the Site meets the deletion criteria. Section V discusses EPA's action to delete a portion of the Site from the NPL unless adverse comments are received during the public comment period.

Section 300.425(e) of the NCP provides that releases may be deleted from the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the State, whether any of the following criteria have been met:

i. Responsible parties or other persons have implemented all appropriate response actions required;

ii. All appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) responses under CERCLA have been implemented, and no further response action by responsible parties is appropriate; or

iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Even if a site or portions of a site are deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA section 121(c), 42 U.S.C. 9621(c), requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, DOE or EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to the partial deletion of this Site:

(1) The EPA consulted with Ohio on the partial deletion of the Site from the NPL prior to developing this direct final notice of deletion.

(2) Ohio concurred with the partial deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final notice of partial deletion, a notice of intent to partially delete is published today in the “Proposed Rules” section of the Federal Register , as well as in a major local newspaper of general circulation at or near the Site, and is being distributed to appropriate federal, state, and local government officials and other interested parties. The newspaper notice announces the 30-day public comment period concerning the notice of intent to partially delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the partial deletion in the site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this document EPA will publish a timely notice of withdrawal of this direct final notice of partial deletion before its effective date and will prepare a response to comments and continue with a decision on the partial deletion based on the notice of intent to partially delete and the comments already received.

Deletion or partial deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion or partial deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions should future conditions warrant such actions.

The following information provides EPA's rationale for deleting Parcel 4 of the Mound Site from the NPL and EPA's finding that the criteria in 40 CFR 300.425(e) are satisfied:

The Mound Site is located in Miamisburg, Ohio, about 10 miles south of Dayton and 45 miles north of Cincinnati. The 306-acre site consists of a number of industrial buildings in the northern portion of the Mound Site, and open land in the southern portion. The Mound Site is located near an ancient Indian mound; hence the name of the DOE facility—the Mound Plant. Parcel 4 is generally bound to the north by the operational area of the plant, to the east by off-site residences, to the south by Benner Road, and to the west by the Miami-Erie Canal. A legal description of Parcel 4 is included in the Record of Decision for Parcel 4, and in the administrative record for the partial deletion decision.

Most of the Site is owned by the United States Department of Energy, which began operations there in 1948 involving the manufacture of triggering devices for nuclear weapons. As a result of past disposal practices and contaminant releases to the environment, including radioactive contaminants, the Mound Site was listed on the NPL on November 21, 1989 (54 FR 48184). DOE signed a CERCLA Section 120 Federal Facility Agreement (FFA) with EPA in October, 1990. In 1993, this agreement was modified and expanded to include OEPA. DOE serves as the lead agency for CERCLA-related activities at the Mound Site.

DOE, EPA, and OEPA originally planned to address the Mound Site's environmental restoration issues under a set of Operable Units(OUs), each of which would include a number of Potential Release Sites (RRSs). For each OU, the site would follow the traditional CERCLA Process: A Remedial Investigation/Feasibility Study (RI/FS), followed by a Record of Decision (ROD) and Remedial Design/Remedial Action (RD/RA). In 1995, after beginning remedial investigations for several OUs, DOE and its regulators concluded that the OU approach was inefficient for Mound due to the number and variety of contaminants on the Site. DOE, EPA, and OEPA agreed that it would be better to evaluate each PRS or building separately, use removal action authority to remediate each one as needed, and establish a goal of no additional remediation other than institutional controls for the final remedy. Following completion of removal actions, a residual risk evaluation would be conducted to ensure that industrial use of the block or building would be safe. DOE, EPA, and OEPA called this approach the “Mound 2000 Process.”

The Mound 2000 Process established a Core Team consisting of representatives of DOE, EPA, and OEPA. The Core Team evaluates each of the potential contamination problems at the Mound Site and recommends the appropriate response. It uses information gathered from site visits, existing data, and knowledge of Mound Plant processes to determine whether or not any action is warranted for potential release sites. If a decision cannot be made based on the information on hand, the Core Team identifies the specific, additional information needed. The Core Team also receives input from technical experts and from the public. Thus, all stakeholders have an opportunity to express their opinions or suggestions for each potential problem area.

In February 2001, DOE conducted a residual risk evaluation for Parcel 4 of the Mound Site. The purpose of the risk evaluation was to assess risks associated with levels of contamination that exist after completion of removal action. The residual risk evaluation method was consistent with the CERCLA baseline risk assessment method to ensure that future users of the land would not be exposed to contaminant levels that would pose unacceptable risks. The residual risk assessment for Parcel 4 determined that limiting use of Parcel 4 to industrial/commercial uses was protective of human health and the environment.

The ROD was signed for Parcel 4 of the Mound Site on March 8, 2001. The selected remedy included institutional controls in the form of deed restrictions on future land and groundwater use. DOE, or its successors, as the lead agency for this ROD, has the responsibility to monitor, maintain and enforce these institutional controls. In order to maintain protection of human health and the environment at Parcel 4 in the future, the institutional controls ensure:

1. Maintenance of industrial/commercial land use;

2. Prohibition against residential use;

3. Prohibition against the use of groundwater;

4. Site access for federal and state agencies for the purpose of sampling and monitoring; and

5. Prohibition against removal of Parcel 4 soils from the DOE Mound property boundary (as owned in 1998) without approval from the Ohio Department of Health (ODH) and the Ohio Environmental Protection Agency (OEPA).

DOE has implemented the ROD for Parcel 4 by placing restrictions in the deed for the Parcel. DOE conveyed Parcel 4 to the Miamisburg Mound Community Improvement Corporation (MMCIC) on April 19, 2001. Because the restrictions have been placed in a Quit Claim Deed for Parcel 4 and that deed has been executed with the transfer of the land to the MMCIC, the restrictions are enforceable and the remedy is considered “implemented'.

While EPA does not believe that any future response actions for Parcel 4 will be needed, if future conditions warrant such action, this area of the Mound Site would be eligible for Fund-financed response actions. This partial deletion affects Parcel 4 only. The remainder of the Site, save for those portions deleted in a previous action (see 66 FR 10371-10374), remain on the NPL.

Under the ROD signed on March 8, 2001, the Department of Energy committed itself to monitor and maintain the institutional controls for Parcel 4 required by the ROD, and to enforce them if necessary. The ROD also required DOE to provide U.S. EPA and Ohio EPA with periodic compliance assessments. Deletion of Parcel 4 from the NPL does not alter in any way DOE's Operation and Maintenance or Long-Term Stewardship obligations under the Parcel 4 ROD. A Long-Term Stewardship Plan is under development for the DOE Mound Plant. Long-Term Stewardship (LTS) is defined as “the physical controls, institutions, information and other mechanisms needed to ensure protection of people and the environment at sites where DOE has completed or plans to complete ‘cleanup’ ( e.g. , landfill closures, remedial actions, removal actions, and facility stabilization). This concept of long-term stewardship includes, inter alia, land use controls, monitoring, maintenance, and information management (This definition of long-term stewardship comes from the 1998 settlement agreement DOE entered into; NRDC, et al. v. Richardson, et al. , Civ. No. 97-963).” The LTS Plan for DOE Mound covers all the above concepts and refers to the processes set up to ensure the effectiveness of the institutional controls. For more information, contact Dann Bird, Miamisburg Mound Community Improvement Corporation, at (937) 865-4266 or Sue Smiley, Department of Energy, at (937) 865-3984.

Because the remedy for Parcel 4 does not allow unlimited use of and unrestricted exposure to the property, DOE is required by Section 121(c) of CERCLA to review the remedy to assure that it continues to protect human health and the environment. While CERCLA requires a review at least once every 5 years after the initiation of remedial action, DOE committed itself to conduct such reviews annually. DOE also committed itself to consult with U.S. EPA, Ohio EPA, and the Ohio Department of Health on these reviews. The first Five-Year Review of the Mound Plant was completed on September 28, 2001. It concluded that the Parcel 4 remedy remains protective of human health and the environment. An additional walkover inspection of the Parcel 4 property was accomplished on May 21, 2002, and no violations of the deed restrictions were documented.

Public participation activities with respect to any response actions in Parcel 4 have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the partial deletion of this Site from the NPL are available to the public in the information repositories.

Deletion of Parcel 4 from the NPL in no way alters the obligations of the Department of Energy under the Federal Facility Agreement under CERCLA Section 120, signed by U.S. EPA, Ohio EPA, and DOE in 1993, including Long-Term Stewardship or Operation and Maintenance responsibilities.

The EPA, with concurrence of the State of Ohio, has determined that the Department of Energy has implemented all appropriate response actions required, and that no further CERCLA response is appropriate to provide protection of human health and the environment. Therefore, EPA is deleting Parcel 4 of the Site from the NPL.

Because EPA considers this action to be non-controversial and routine, EPA is taking it without prior publication. This action will be effective December 2, 2002, unless EPA receives adverse comments by November 1, 2002. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect. EPA will prepare a response to comments and as appropriate continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

In the December 19, 1997 Federal Register (62 FR 66726), we published a proposed rule that detailed our plans to revise all of the hospital conditions of participation (CoPs), emphasizing lessening Federal regulations to eliminate unnecessary structural and process requirements, focus on outcomes of care, allow greater flexibility to hospitals and practitioners to meet quality standards, and place a stronger emphasis on quality assessment and performance improvement. The proposed rule introduced our intent to include a new Patients' Rights CoP for hospitals. We solicited comments and received strong support for the establishment of the new CoP from the public, mental health advocacy groups, the media, and the Congress.

After the proposed rule was published, reports of injuries and deaths associated with the use of restraints and seclusion increased our concern about patient safety. State surveyors, patient advocacy groups, the media, and the public also brought complaints about hospital violations of patients' rights to our attention. These violations included denying or frustrating patients' access to care, denying patients' full involvement in their treatment, disregarding patients' advance directives, and denying patients access to their records. In the July 2, 1999 Federal Register (64 FR 36070), we published an interim final rule with comment period to address these concerns and assure patient safety. The rule set forth requirements supporting and protecting patients' rights in the hospital setting, specifically, the right to be free from the inappropriate use of seclusion and restraint, with requirements to protect the patient when use of either intervention is necessary.

The interim final rule with comment period was challenged in United States District Court for the District of Columbia by the National Association of Psychiatric Health Systems, the American Hospital Association, the Sheppard and Enoch Pratt Foundation, Incorporated, and Acadia Hospital. ( See National Association of Psychiatric Health Sys. v. Shalala , 120 F.Supp.2d 33 (D.D.C. 2000).) Plaintiffs challenged one provision of the new CoP, the requirement that hospitals must provide for an in-person evaluation of a patient by a physician or other licensed independent practitioner (LIP) within 1 hour of initiating the use of restraint or placing the patient in seclusion to address the patients' violent or aggressive behavior. ( See § 482.13(f)(3)(ii)(C).)

On September 14, 2000, the Court ruled in favor of the Secretary with respect to the plaintiffs' challenge under the Administrative Procedures Act; however, the Court ruled against the Secretary with respect to the plaintiffs' claim that the rule failed to fulfill certain requirements of the Regulatory Flexibility Act (RFA). In its decision, the Court noted that the RFA requires—

• A succinct statement of the need for and objectives of the rule;

• A summary of and response to the significant issues raised by public comments to the RFA assessment in the notice of proposed rulemaking;

• A description and estimate of the number of small entities to which the rule will be applied;

• A description of the projected reporting and recordkeeping requirements of the rule, including an estimate of the effect that the recordkeeping requirements will have on small entities; and

• A description of the efforts the agency has taken to minimize the significant economic impact of the rule on small businesses, including a discussion of the less restrictive alternatives considered and rejected.

The Court, noting that the Secretary had not made a “reasonable good faith effort to canvass major options and weigh their probable effects,” concluded that the agency failed to satisfy the fifth element of the Regulatory Flexibility Act. The case was remanded to the Department of Health and Human Services for completion of a compliant RFA without enjoining continued enforcement of the requirements of the interim final rule with comment period. Accordingly, we are publishing this notice to discuss the alternatives that we considered when developing the July 2, 1999 interim final rule with comment period.

When we published the July 2, 1999 interim final rule with comment period, we lacked critical factual reports, studies, and data that would have aided in the development of specific cost or savings estimates. This factor continues to be an obstacle in providing cost estimates on the impact of some of the requirements.

At the time of the publication of the July 2, 1999 interim final rule with comment period, at least 80 percent of the 6,116 inpatient hospitals that participate in the Medicare or Medicaid programs were subject to existing accreditation requirements pertaining to the use of restraints and seclusion. While the pre-1999 Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) requirements did not contain all elements addressed by the interim final rule with comment period, many parallel standards were in place. There were two major differences between JCAHO's standards and our standards. The first is that JCAHO did not require the 1-hour face-to-face assessment but instead required a phone call to the LIP. The second is that JCAHO's monitoring requirements were more stringent than ours. It is worth noting that JACHO is enforcing all of our requirements, including the 1-hour rule, when conducting accreditation surveys. Accredited hospitals operated in an atmosphere that emphasized the elimination of unnecessary restraint, monitoring use, and reporting sentinel events to the JCAHO. Therefore, we approximated that 4,893 facilities were already subject to restraint and seclusion requirements. The remaining 1,223 facilities (non-profit, proprietary, and government-funded) would be subject to any existing state laws concerning the use of restraint and seclusion. Additionally, at least two States (New York and Pennsylvania) had established detailed regulations and policies regarding the use of restraint and seclusion in State-run and private facilities. Therefore, we concluded that the majority of hospitals were already affected by restraint and seclusion-related requirements, even if they were not equal in all points to the requirements specified in the interim final rule with comment period. Thus, although Medicare- and Medicaid-participating hospitals have diverse characteristics, many are accredited; and therefore, could be assumed to have been meeting pre-existing accreditation standards at the time the interim final rule with comment period was published.

Furthermore, with the increasing amount of research and literature identifying the potential hazards associated with restraint use, some hospitals were already engaged in efforts to reduce the use of restraints. The variations among hospitals, the lack of data on the prevalence of restraint or seclusion use in hospitals, and the trend of restraint use reduction efforts created problems in the formulation of a specific estimate for the interim final rule with comment period. While these were obstacles to the formulation of an estimate for the interim final rule with comment period, we invite hospital feedback on these points so that we may use this information in formulation of the final rule and its impact estimate.

Our regulations in § 482.13(e) and (f) prohibit the use of restraint and seclusion for purposes of coercion, discipline, convenience or retaliation by staff. These regulations also establish procedures that apply when hospitals use restraint or seclusion.

We considered developing one set of general requirements regulating restraint and seclusion use in all hospitals. However, based on public comments and recent concern regarding the risks associated with restraint and seclusion use for behavior management situations, we concluded that one set of requirements did not afford patients with adequate protections. Moreover, we believe that it is important to maintain consistency between Federal and accreditation standards. Therefore, we adopted an approach to restraints and seclusion similar to the existing standards that JCAHO created (for example, differentiating between situations when a restraint is being used to manage behavior and the concept of time limited orders). Accordingly, we made a distinction between restraint use in the provision of acute medical and postsurgical care (§ 482.13(e)) and restraint and seclusion use for the management of aggressive or violent behavior (§ 482.13(f)).

Section 482.13(e)(5) requires that staff with direct patient contact (that is, staff who may be involved either with the application of a restraint or the monitoring, assessment, or reevaluation of a restrained or secluded patient's condition) are provided with ongoing education and training in the proper and safe use of restraints. Section 482.13(f)(6) parallels these requirements and adds that staff involved in the application of a physical restraint or seclusion to manage aggressive or violent behavior must receive additional training in alternative methods for handling behavior, symptoms, and situations that have been traditionally treated using restraints or seclusion.

When writing the interim final rule with comment period, we considered the burden of requiring training on the use of restraints and seclusion for all staff members with direct patient contact. We believed that some persons inaccurately construed the requirement to entail the training of dietary, administrative, housekeeping, and other types of staff who are not involved in the application or use of restraints or seclusion. ( See Tag A797, Appendix A of the State Operations Manual, HCFA Pub. No. 7, page A196.)

Most hospitals that participate in Medicare or Medicaid already have some type of training program; therefore, we believed that these requirements refine existing programs rather than mandate new ones. JCAHO's standards are applicable to accredited hospitals (currently 80 percent of Medicare- and Medicaid-participating hospitals) and require a similar training program for staff involved with the application of restraints or seclusion. (See JCAHO's 2000 Comprehensive Accreditation Manual for Hospitals standard TX 7.1.1.3 (which indicates that staff orientation and education create a culture emphasizing prevention and appropriate use of restraint or seclusion as well as encouraging alternatives) and standard TX 7.1.3.1.4 (which requires that restraint or seclusion is only used correctly by competent, trained staff)).

Lastly, we considered no training requirements; however, the Hartford Courant newspaper series indicated that training programs are a key ingredient in assuring a reduction in patient injuries and deaths associated with the use of restraints and seclusion. To omit this requirement in the interim final rule with comment period would have been to leave a critical gap in the strategy to improve patient care and assure patient safety.

The hospital CoPs require continuous face-to-face monitoring of a patient who is simultaneously physically restrained and secluded to address violent or aggressive behavior. As an alternative, continuous monitoring may occur through the use of both video and audio equipment, with the monitoring occurring in close proximity to the patient to allow quick intervention when needed.

We agree that this requirement may incur costs for hospitals, depending on their current practice. However, we believed that the training required by the July 2, 1999 interim final rule with comment period equipped staff with alternative methods for handling violent or aggressive patient behavior thereby reducing overall use of restraint or seclusion.

We did not require that this monitoring be done by a registered nurse. It could be performed by a nursing assistant or other staff member who has completed the required training.

We considered only requiring periodic monitoring when the two interventions are used simultaneously. However, we concluded that the instances meriting dual use of restraint or seclusion would be so rare and extreme that they would indicate a need for greater staff vigilance. Restraint and seclusion can actually increase the patient's agitation, and staff should be available to help the patient regain self control, thus ending one intervention or both as quickly as possible. Leaving a distressed patient alone for half an hour or longer, not understanding what is happening to him or her, does not facilitate the patient's recovery of his or her self-control. We concluded that uninterrupted monitoring assures that if the patient becomes more distressed by the intervention, staff can assist quickly.

The interim final rule with comment period requires face-to-face assessment, by a physician or other LIP within one hour of the initiation of the intervention, of a patient who has been restrained or secluded to manage his or her violent or aggressive behavior. We considered whether this requirement was impossible to fulfill because of the lack of available personnel, geographic barriers, and costs associated with this degree of coverage. We also considered whether a required onsite evaluation by a physician or LIP is too costly or without a demonstrable benefit in many cases.

When the interim final rule with comment period was published in July 1999, we were not aware of any data regarding the appropriateness of the 1-hour timeframe and we solicited, but did not receive, comments providing data undercutting this requirement.

In including the 1-hour provision, we considered that hospitals are required to have 24-hour physician coverage. Section 482.12(c)(3) requires that the governing body of the hospital must ensure that a doctor of medicine or osteopathy is on duty or on call at all times. The interim final with comment period did not change this requirement or require hiring of new staff or having a physician onsite at all times. When staff are trained in alternatives to restraint or seclusion, prevalence of use should decline so that restraint or seclusion is used only as a last resort. We understand that for certain patient populations, such as for those who have self mutilating behaviors, a requirement for recurring onsite visits to assess the use of a restraint that is part of the patient's treatment plan may not be needed or appropriate. We plan to address these uses in forthcoming interpretive guidelines. Additionally, we reiterate that uses of restraint that occur in conjunction with an acute care need do not trigger the need for evaluation of the patient by a physician or other LIP within one hour. These uses may include, for example, a patient who is attempting self-extubation or tearing at lines whose behavior cannot be handled through less restrictive means.

In establishing this requirement, we considered onsite physician-only assessment within half an hour, which is the policy in one State's mental health system. However, we believed that this timeframe would not be reasonable in rural or remote areas, and therefore; we did not impose this requirement.

We also considered less prescriptive approaches. For example, we could have drafted regulations that remained silent on this point. However, various sources of information, including the press indicated that the patient is at high risk for injury when being restrained or secluded in an effort to manage his or her violent or aggressive behavior. ( See “Deadly Restraint: A Hartford Courant Investigative Report,” with articles from October 11 through 15, 1998). Often patients are medically complex, with concomitant medical and psychiatric symptoms and conditions. When staff must resort to restraint or seclusion to protect the patient or others, it is essential to examine: (1) The immediate situation, that is whether the patient has been injured by the intervention; (2) the patient's reaction to the intervention; (3) the patient's overall medical and psychiatric condition; and (4) whether the behavior may stem from a condition that can be remedied quickly. Such a determination is a medical decision that requires the integration of many pieces of information, and therefore; merits a physician's or other LIP's attention.

We also considered other options that may be perceived as less burdensome. We could have drafted regulations that remained silent on the timeframe for a physician's or other LIP's assessment of a restrained or secluded patient. This alternative may be feasible for the types or uses of restraint described in § 482.13(e). In these types of situations, we left to the physician's or other LIP's discretion the decision of whether immediate, inperson assessment is required. In an instance when an armboard is applied to prevent accidental dislodging of an intravenous needle, arguably the application of the restraint does not represent a significant change in the patient's status, nor does the armboard pose a grave hazard to the patient's health or safety. In contrast, a patient's attempt to self-extubate could warrant immediate physician attention, depending on the patient and whether this behavior represents a marked change in status. However, we believed that requiring an inperson assessment within 1 hour for the variety of restraint uses under § 482.13(e) was not feasible because of the wide range of circumstances covered by that standard.

On the other hand, § 482.13(f) is more focused. We considered whether immediate attention was necessary when restraint or seclusion was used to manage a patient's violent or aggressive behavior. We recognized that the types of behavior that warrant the patient's placement in seclusion or the application of restraint often create a situation in which both the patient and staff are at risk for injury. The patient who is resisting staff restraint in this situation is unlike the noncombative patient who had an armboard applied. This patient has transitioned from seemingly calm behavior into a state at which an extreme measure has been undertaken to protect him or her. As discussed in the preamble to the interim final rule with comment period, we concluded that quick, medical involvement is warranted to assure safety and to develop a plan to avert or diminish further conflict. We believed that the maximum timeframe of 1 hour established by this rule is a reasonable one.

We also considered permitting a staff member to perform a patient assessment through telephone consultation with a physician or other LIP. Given the complexity of the patient population, we did not select this option. Physicians and LIPs are extensively trained in assessment of symptoms and behaviors, in physical examination and formulation of diagnoses and resulting treatment strategies. Staff who are onsite may have widely disparate assessment skills. Some hospitals may staff patient care areas with licensed practical nurses or other available staff. We are not persuaded that these staff members have the physical and psychiatric assessment skills that correspond to the medical complexity of a patient in crisis. Accordingly, we opted not to permit patient assessment through telephone consultation.

The implementation of the Patients' Rights CoP served to protect not only Medicare and Medicaid beneficiaries, but all patients receiving care in any of the 6,166 Medicare- and Medicaid-participating hospitals (that is, acute care, psychiatric, rehabilitation, long-term care, children's, and alcohol-drug) including small rural hospitals. Our goal is to safeguard against the mistreatment of all patients in these facilities including, but not limited to— (1) Deaths due to inappropriate restraint or seclusion use; (2) violation of patients' privacy and confidentiality in various aspects of the healthcare delivery process; and (3) systematic frustration of the patients' efforts to acquire his or her medical records. Patients benefit from the hospitals' focus on patients' rights. Through these protections, patient care can be delivered in an atmosphere of respect for an individual patient's comfort, dignity, and privacy. The interim final rule with comment period emphasizes the importance of staff training, adequate monitoring and assessment, and prompt evaluation of restrained or secluded patients. As these factors, lack of training, evaluation, monitoring, and assessment were involved in the deaths reported by the media, we believed that implementation of the Patients' Rights CoP would lead to a reduction in the number of restraint- and seclusion-related injuries and deaths in hospitals. The following chart represents the data that we have received from providers regarding deaths that may have been related to restraint or seclusion use:

We did not expect the implementation of the new Patients' Rights CoP to generate significant costs to the Medicare or Medicaid programs. We did not believe that there would be any additional costs to the survey and certification program as compliance with this new CoP either would be reviewed through a routine, nonaccredited hospital survey, a validation survey or as part of a complaint survey.

The Patients' Rights CoP introduced new Federal requirements that in many instances reflected existing State, accreditation or professional standards. These new Federal requirements are set forth in six standards to ensure minimum protections of each patient's physical and emotional health and safety. These standards address the patients' right to—

• Be notified of his or her rights;

• Exercise his or her rights in regard to his or her care;

• Privacy and safety;

• Confidentiality of and access to his or her medical records;

• Freedom from restraints used in the provision of acute medical and postsurgical care unless clinically necessary; and

• Freedom from restraint and seclusion use to manage violent or aggressive behavior unless clinically necessary.

Comments received timely will be available for public inspection as they are received, generally beginning approximately three weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, call (410) 786-7197.

To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-888-293-6498) or by faxing to (202) 512-2250. The cost for each copy is $10. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register .

This Federal Register document is also available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing Office. The Web site address is: http://www.access.gpo.gov/nara/index.html.

Influenza and pneumonia combined represent the fifth leading cause of death in the elderly. The 1999 RAND report prepared for the Centers for Medicare & Medicaid Services (CMS), “Interventions that Increase the Utilization of Medicare-Funded Preventive Services for Persons Age 65 and Older,” states that “influenza and consequent respiratory diseases are common causes of morbidity and mortality in the United States each year, with 20,000 to 40,000 deaths reported for each influenza epidemic. Over 90 percent of these deaths occur among those age 65 or older.” The report also states that influenza vaccination “has been shown to be efficacious in the elderly, decreasing hospitalizations by 27 percent to 57 percent and deaths by 27 percent to 30 percent.” ( http://www.cms.hhs.gov/healthyaging/2a.asp. )

The Center for Health Research, a part of the Kaiser Permanente managed care organization, studied the cost-effectiveness of influenza vaccination over nine flu seasons in its northwest region in a study published in 1993. The study examined experiences of some 69,000 elderly members of the health maintenance organization who experienced 3,105 outpatient pneumonia and influenza episodes, 894 hospitalizations, and 113 pneumonia and influenza deaths. The estimated cost of providing a vaccination was $7.11; average medical care costs for outpatient and inpatient episodes were $106 and $5,730, respectively, for high-risk elderly patients, and $141 and $4,477 for non-high-risk elderly patients. A similar study examined the cost-effectiveness of vaccinating elderly members of a Minnesota health plan against influenza over three seasons beginning in 1990. The plan, Group Health Inc. of Minneapolis, vaccinated 45 percent to 58 percent of its members over age 64. Vaccinated individuals had lower hospitalization rates for flu, pneumonia, congestive heart failure, and other illness, for an average savings of $117 per vaccinated member. (“The costly toll of vaccine-preventable disease.” Business and Health; Montvale; 1995; (13)(3)16; Leavenworth, Geoffrey.)

Despite the availability of safe and effective vaccines and substantial progress in reducing vaccine-preventable diseases, improving the delivery of the vaccines is vital to further reduce and eliminate vaccine-preventable causes of morbidity and mortality. The administration of influenza and pneumococcal polysaccharide vaccines per standing orders, governed by the physician-approved policies and procedures of the facility or agency, after assessments for contraindications, is the most consistently effective method for increasing adult vaccination rates and the least burdensome to implement.

Influenza vaccine is the primary method for preventing influenza and its more severe complications. The Advisory Committee on Immunization Practices (ACIP) reported in 2002 that the primary target group for influenza vaccination includes persons who are at high risk for serious complications from influenza, including approximately 35 million persons who are more than 65 years of age, and approximately 33 to 39 million persons less than 65 who have chronic underlying medical conditions. Beginning with the 2000 to 2001 influenza season, the ACIP has added persons aged 50 to 64 years to the primary target group for annual influenza vaccination. This age group was added because a substantial proportion of persons aged 50 to 64 years (estimated at between 24 percent and 32 percent of the total population) have one or more chronic medical conditions that place them at high risk for influenza-related hospitalization and death. Rates of influenza-related excess hospitalization among adults younger than age 65 years old with one or more high-risk conditions have been estimated at 392 to 635 per 100,000 persons compared with 13 to 23 per 100,000 among those without high-risk conditions. There are minimal adverse reactions or side effects related to influenza vaccines because, as the Morbidity and Mortality Weekly Report (MMWR) states, “inactivated influenza vaccine contains noninfectious killed viruses and cannot cause influenza.” The most frequent side effect of vaccination is soreness at the vaccination site that lasts less than 2 days. Fever, malaise, myalgia, and other systemic symptoms can occur but recent placebo-controlled trials demonstrate that among older persons and healthy young adults, administration of split-virus influenza vaccine is not associated with higher rates of such systemic symptoms when compared with placebo injections. The potential benefits of influenza vaccination in preventing serious illness, hospitalization, and death greatly outweigh the vaccine reactions. (“Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP).” MMWR 51; RR03, (April 12, 2002) (“ACIP Recommendations”)). The availability of safe and effective vaccines and substantial progress in the direction of reducing vaccine-preventable diseases has not produced the expected outcome, due to the lack of proper delivery in a timely manner to the targeted populations.

The Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention (CDC) recognize the major impact of both influenza and pneumococcal disease on the residents of long-term care facilities, and the effectiveness of vaccines in reducing health care costs by preventing illness and hospitalization, and have collaborated to improve immunization coverage through standing orders. The goal is to immunize at least 90 percent of the institutionalized population to meet our Healthy People 2010 objectives through a national quality improvement program and to promote standing orders for immunization programs to ensure that all nursing facility residents are assessed for and offered influenza and pneumococcal vaccinations. (For more information on our Healthy People 2010 immunization goals and health objectives for the nation, in general, please see http://www.health.gov/healthypeople. ) Standing orders programs authorize licensed practitioners, where allowed by State law, to administer vaccinations, after assessment for contraindications, according to a physician-approved facility or agency policy without the need for a physician's order. One of the key findings of the 1999 RAND report is that organizational changes are effective in improving the delivery of preventive services. Standing orders are a type of organizational change that allow appropriate non-physician staff to offer vaccinations, after assessment for contraindications, without an individual physician order, according to the facility or agency policy. The ACIP recommends implementing standing orders in nursing homes and hospitals. We have included home health agencies (HHAs) in this rule as providing vaccines in settings accessible to adults is critical and the need to use transportation to reach a health-care provider is a barrier to receiving preventive services. This barrier may be eliminated by offering vaccines in such convenient locations as homes, where HHAs already provide other services.

The Conditions of Participation (CoPs) are Federal requirements that establish basic health and safety standards that providers of health care services, such as hospitals and LTCFs, must meet in order to participate in the Medicare and Medicaid programs. However, the protection afforded by the Medicare and Medicaid CoPs apply to all patients regardless of payer source. Although the goal of the changes to the CoPs is to increase adult immunizations, the changes brought about by this rule could also be used by hospitals, HHAs, and LTCFs to implement immunization policies to improve flu and pneumonia immunization rates for children and adolescents.

The provisions of the final rule will remove the Federal barrier related to the physician's order requirement for influenza and pneumococcal immunizations in Medicare and Medicaid participating hospitals, long-term care facilities (LTCFs), and HHAs. Preventing morbidity and mortality due to severe influenza and its complications is one of the goals of this regulation. During the influenza season, hospitalization rates for high-risk populations increase two to five-fold, depending on the age group. Influenza-associated mortality is a major concern for persons with chronic diseases; this mortality increase is most marked in persons 65 years of age or older, with more than 90 percent of the deaths attributed to pneumonia and influenza occurring in persons of this age group. (“Prevention and Control of Influenza Indications for Influenza Vaccine.” Disease Prevention News, Vol. 57, No. 20, September 20, 1997.) The proportion of elderly persons in the U.S. population is increasing, and age and its associated chronic diseases can increase the severity of influenza illness. Unless control measures are more vigorously implemented, the number of deaths from influenza and its complications is expected to increase.

According to the article, each year, more people die of pneumococcal pneumonia alone than die of breast cancer and AIDS combined. According to the CDC, an estimated 40,000 deaths annually in the United States are attributed to pneumococcal infection. Immunization of high-risk persons could prevent up to half of these deaths. As of 1993, Medicare began reimbursing providers for influenza vaccine and its administration ( http://cms.hhs.gov/preventiveservices/2a.asp ). However, only 23 percent of one of the highest-risk groups, persons aged 65 years and older, had received vaccination against pneumococcal disease. Section 4107 of the Balanced Budget Act of 1997 “extended the influenza and pneumococcal vaccination campaign conducted by CMS in conjunction with CDC and the National Coalition for Adult Immunization through fiscal year 2002, authorizing $8 million for each fiscal year from 1998 to 2002.” Even with these changes in Medicare reimbursements, the rates of immunization did not improve as anticipated. A tragic example of these national trends occurred in Texas. In January 1997, a local health department alerted the Texas Department of Health to three laboratory-confirmed Streptococcal pneumoniae infections at a Northeast Texas nursing home with 90 residents. Pneumococcal vaccine had been administered to only 10 (11 percent) of the residents before the outbreak. The remaining nursing home residents were promptly vaccinated and given antibiotics to prevent further cases. However, two of the three patients with laboratory-confirmed infections died. A decade of use has confirmed the efficacy and safety of the current vaccine against pneumococcal disease. Moreover, the vaccine is inexpensive, and Medicare reimburses its cost.

In summary, immunizations save lives and can help avoid needless suffering and unnecessary costs caused by complications from various infectious diseases, and, as many family members and health care workers know, they can prevent the infection of others. However, despite the availability of safe and effective vaccines, substantial portions of susceptible adults are not being immunized. Our report in 2000 on the 1999 data indicate that 35 percent of the population age 65 or older has received the pneumococcal vaccine and 45 percent of the population age 65 or older has been immunized against the flu ( http://cms.hhs.gov/preventiveservices/2d.asp ). To reduce the morbidity and mortality rates, delivering appropriate vaccinations in a timely manner is vital. Maintaining high levels of vaccination coverage and low rates of vaccine-preventable diseases is the goal of this final rule. Standing orders will decrease vaccine-preventable diseases and improve adult vaccination rates because they are the most consistently effective method for increasing adult vaccination rates and are easy to implement.

The report on “Use of Standing Orders Programs to Increase Adult Vaccination Rates” (MMWR 2000/49 RR01 15-26, March 24, 2000) (Standing Orders Report)), briefly reviews the evidence on the effectiveness of standing orders programs, describes standards for program implementation, and recommends initiating these programs to improve immunization coverage in several traditional and nontraditional settings. The report states that in recent years, a rapid emergence of antimicrobial resistance among pneumococci, especially to penicillin, has occurred. Increasing pneumococcal vaccination rates could help prevent invasive pneumococcal disease caused by vaccine-type, multidrug-resistant pneumococci. Outbreaks of pneumococcal disease caused by a single drug-resistant pneumococcal serotype have occurred in institutional settings, including nursing homes. The same MMWR report states that in 1999, because of concerns about pneumococcal antimicrobial resistance and underuse of pneumococcal vaccine, the American Medical Association and several partner organizations issued a Quality Care Alert that supports ACIP's recommendations for pneumococcal vaccination.

The provisions of the final rule will remove the Federal barrier related to the physician's order requirement for influenza and pneumococcal immunizations in Medicare and Medicaid participating hospitals, LTCFs and HHAs, that have such a requirement. In developing a facility or agency policy for immunizing patients/residents, there must be input from the medical director or a physician. We discuss examples of core aspects of facility policy under the direction of the medical director or a physician below. However, this policy is not limited to these examples, and the specific circumstances of each beneficiary must be taken into account.

The most basic and vital aspect of facility policy must be patient assessment. Patient assessment is a mandatory element of professional practice standards for any procedure performed. This requirement, therefore, is not an exception, or a new practice even though we wish to emphasize its importance here. Assessment of possible contraindications must be carried out before vaccines are administered. Inactivated influenza vaccine should not be administered, for example, to persons known to have anaphylactic hypersensitivity to eggs, or to other components of the influenza vaccine, without first consulting a physician. Prophylactic use of antiviral agents is an option for preventing influenza among these persons. However, persons who have a history of anaphylactic hypersensitivity to vaccine components but who are also at high risk for complications from influenza can benefit from the vaccine after appropriate allergy evaluation and desensitization. Information regarding vaccine components can be found in package inserts from each manufacturer. Similarly, persons with acute febrile illness usually should not be vaccinated until their symptoms have abated. However, minor illnesses with or without fever do not contraindicate the use of the influenza vaccine, particularly among children with mild upper respiratory tract infection or allergic rhinitis (ACIP Recommendations). The Standing Orders Report states that standing orders protocols should also specify that vaccines be administered by healthcare professionals trained to (a) screen patients for contraindications to vaccination, (b) administer vaccines, and (c) monitor patients for adverse events, in accordance with State and local regulations.

We are changing the current requirements in the first sentence of our condition of participation for hospitals, at 42 CFR. 482.23(c)(2), to read “All orders for drugs and biologicals must be in writing and signed by the practitioner or practitioners responsible for the care of the patient as specified under § 482.12(c) with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment for contraindications.”

The September 2000 issue of the Journals of Gerontology includes an article that refers to a study that reviewed hospitals' data on influenza vaccination rates among hospitalized older adults that showed that in-hospital influenza vaccination rates for older adults were well below 5 percent (“Standing Orders for Influenza Vaccination Increased Vaccination Rates in Inpatient Settings Compared with Community Rates.” The Journals of Gerontology; Washington; Sep 2000; Vol. 55A; 9; M522-M526; Fiona Lawson; Vicki Baker; Dick Au; Janet E. McElhaney). The main barrier to vaccination was the requirement for a physician's order; other issues were that most of the medical staff did not view vaccination as a priority, or were concerned that vaccination might not be effective or might complicate the patient's course of treatment while in the hospital. Because an educational program was predicted to be ineffective for changing in-hospital practices of the attending staff, an influenza immunization program using a standing order under the principal investigator for the study was designed. The purpose of the study was to increase vaccination rates in this very high-risk group of hospitalized older adults. The result after implementation of the inpatient immunization program was an increase of 22 percent in the immunization rate. The study also found that in spite of many unvaccinated patients indicating that they would be vaccinated after discharge, only 1 percent were vaccinated in the community after discharge from the hospital.

Specific recommendations for hospital-based immunization were first published by ACIP in the 1980s—for influenza vaccine in 1986, and for pneumococcal vaccine in 1989. These recommendations were included in the Standards of Adult Immunization Practice that were issued by the National Coalition for Adult Immunization in 1990, and appeared in the second edition of the American College of Physicians' Guide for Adult Immunization (1990). Soon thereafter, hospital-based influenza and pneumococcal vaccination was recommended in the National Vaccine Advisory Committee's report on adult immunization and in a critical report published by the General Accounting Office. Subsequently, this strategy was included in the action plan for adult immunizations developed by the CDC and CMS, and was later endorsed by the Task Force on Community Preventive Services. It also was emphasized in a comprehensive report prepared for CMS by the RAND Corporation to provide evidence-based recommendations for increasing the use of Medicare-funded preventive-care services. (“Hospital-Based Influenza and Pneumococcal Vaccination: Sutton's Law Applied to Prevention,” David S. Fedson, MD; Peter Houck, MD; Dale Bratzler, DO, MPH, Infection Control and Hospital Epidemiology, Volume 21(11) (692-699), November 2000.) (Fedson).

The most remarkable example of success with hospital-based immunization is the program that was conducted at the Minneapolis Veterans Affairs Medical Center since 1984. This hospital-wide program initially focused on influenza vaccination of outpatients and used a combination of administrative, organizational, and patient oriented interventions. No specific attempts were made to involve physicians. Instead, the program was implemented by nurses according to a hospital policy that allowed them to vaccinate patients without a signed physician's order. By 1987, the program was vaccinating 60 percent of the hospital's elderly outpatients; by the late 1990s, almost 90 percent were regularly receiving influenza vaccine, most of them through the hospital's program.

Among successful programs for hospital-based influenza and pneumococcal vaccinations, a standing order is probably the most important feature. The ACIP has specifically recommended that standing orders be used to increase adult vaccination rates in all settings. Furthermore, none of the successful programs described thus far in the literature has depended on active physician participation. Instead, nurses or pharmacists have been responsible for their implementation. (Fedson, 692-699).

We are changing our current regulations in the Conditions of Participation for LTCFs at § 483.40 (b)(3) to read “the physician must sign and date all orders with the exception of orders for the administration of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved facility policy after an assessment for contraindications.”

There were 1,590,763 individuals over 65 years of age in LTCFs in the United States in 1990, and the number is estimated to grow to 2.9 million by 2020. (“Increasing Pneumococcal Vaccination Rates Among Residents of Long-Term Care Facilities: Provider-Based Improvement Strategies Implemented by Peer-Review Organizations in Four Western States.” Kurt B. Stevenson, MD; John W. McMahon, Sr, MD; Jan Harris, MSHA, CHE; J. Richard Hillman, MD; Steven D. Helgerson, MD, MPH. Infection Control and Hospital Epidemiology, Volume 21 (11) (705-710) November 2000). (Stevenson). A substantial increase in vaccination rates among such a large population will prevent a significant number of cases of influenza and pneumococcal bacteremia and related deaths. Standing orders appear to be one intervention effective in sustaining successful vaccination efforts.

We are changing the first sentence of the current requirements in the CoPs at § 484.18(c) for HHAs to read “drugs and treatments are administered by agency staff only as ordered by the physician, with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per agency policy developed in consultation with a physician, and after an assessment for contraindications.” HHA staff must include the immunization information on the patient's plan of care, although a physician's order is not required for influenza and pneumoccal vaccines.

Providing vaccines in settings readily accessible to adults who are most in need of the services is critical. For many adults, the need to use transportation to reach a healthcare provider is a barrier to receiving preventive services. This barrier may be eliminated by offering preventive services (for example, administration of vaccines) in convenient locations such as the patient's home. Eliminating the need for making an appointment in advance and avoiding the waiting time often associated with a clinic or office visit are factors that also might increase the opportunities for some adults to receive needed vaccinations. (“Adult Immunization Programs in Nontraditional Settings: Quality Standards and Guidance for Program Evaluation; A Report of the National Vaccine Advisory Committee.” MMWR 49 (RR01)1-13. March 24, 2000.)

The 1999 RAND report states that the proportion of the U.S. population over age 65 has increased from 5 percent in 1900 to 13 percent in 1997. This change in demographics, combined with an increase in average life expectancy, has highlighted the importance of preventive care services for older individuals. According to an October 1997 JAMA article, vaccination of elderly people against pneumococcal bacteremia is one of the few interventions that have been found to both improve health and save medical costs. (“Cost-effectiveness of Vaccination Against Pneumococcal Bacteremia Among Elderly People.” JAMA; Chicago; Oct 22-Oct 29, 1997; 278;16; Jane E Sisk; Alan J Moskowitz; William Whang; Jean D Lin; et al. )

Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and its reasons in the rule issued.

The delay in publishing this rule would be extremely detrimental to the health of beneficiaries, as epidemics of influenza typically occur during the winter months and are responsible for an average of approximately 20,000 to 40,000 deaths per year in the United States. Influenza viruses also can cause pandemics, during which rates of illness and death from influenza-related complications can increase dramatically. Rates of infection are highest among children, but rates of serious illness and death are highest among persons older than 65 years of age and persons of any age who have medical conditions that place them at increased risk for complications from influenza and pneumonia. Vaccines are the most effective means to protect against many complications related to influenza and pneumonia. The ACIP recommendations for 2002 to 2003 to decrease the risk of influenza state that the optimal time for influenza vaccinations is October through November. Therefore, it is imperative that this rule is published as a final rule immediately and the immunization process be implemented without delay this year so that influenza-related complications can be prevented. The goal of CMS and CDC, to immunize at least 90 percent of the adult population to meet the Healthy People 2010 objectives, can be attained earlier if the barrier requiring a physician's order is removed as soon as possible. Even though pneumococcal vaccines can be administered throughout the year the percentage of patients and or residents immunized remains low. Therefore, this final rule will be a vehicle to improve coverage and will be consistent with the Healthy People 2010 objectives.

We believe that a continued delay in implementation of this final rule would greatly hinder increased immunizations of beneficiaries in the affected facilities before the onset of this year's flu season. As a result, we have concluded that, in this instance, a notice-and-comment period, and a further delay in this rule's effective date is unnecessary and contrary to the public interest. We find, on this basis, that there is good cause for waiving the notice-and-comment period and for establishing this immediate effective date under 5 U.S.C. section 808(2).

This document does not impose information collection and recordkeeping requirements. Consequently, this document does not need to be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.

We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year). This rule removes the barrier for an individual physician's order to be necessary to administer influenza and pneumococcal polysaccharide vaccines and is a requirement that has benefits in improving patient and resident health and in reducing health care spending. While it is not possible at this point to determine definitively the additional costs to the Medicare and Medicaid programs from increased immunizations resulting from this rule, we believe that the impact will be below the threshold of $100 million and will not be economically significant.

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 to $29 million in any one year. For purposes of the RFA, all hospitals, LTCFs, and HHAs, are considered to be small entities. Individuals and States are not included in the definition of a small entity. For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. This regulation does not have any impact on small rural hospitals that would be burdensome; instead rural hospitals will benefit from the implementation of the rule, as the overall cost associated with treating influenza and pneumococcal disease will be reduced.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This rule will not have any effect on the governments mentioned or on private sector costs.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have any effect on State or local governments. The costs related to the influenza and pneumococcal polysaccharide vaccines are currently a covered benefit for beneficiaries. In fact, this rule will remove the barriers that may have impacted the flexibility of State law in implementing immunization related requirements.

We expect that these providers will benefit from the implementation of this rule, as prevention of influenza and pneumonia will lower hospitalization rates, resulting in cost reductions.

We do not expect the provisions of this final rule to affect other providers.

While it is not possible at this point to determine definitively the additional costs to the Medicare and Medicaid programs from increased immunizations resulting from this rule, we believe that, due to the low cost for the immunizations, any budget impact to these programs would be negligible. Moreover, increased immunizations may help reduce the estimated $12 billion dollars in direct and indirect costs to society annually during severe influenza epidemics. Moderate epidemics cause more than 20,000 to 40,000 hospitalizations and estimated direct costs of up to $1 billion per year. (“It Pays to Immunize Adults.” Therese M. Droste. Business and Health; Montvale. Sep. 1998; 16; 8-11.) According to the 1997 JAMA article, the first pneumococcal polysaccharide vaccine was marketed in the United States almost 20 years ago, and two Federal studies have assessed its cost-effectiveness in preventing pneumococcal pneumonia in elderly people (JAMA; Oct 22-29, 1997; 278:1333-1339). In both analyses, vaccination was found to be cost-effective, that is, a reasonable investment for the health benefits gained. This article also states that even though savings cost is not the appropriate criterion for assessing an intervention, the issue is whether the investment in an intervention is worth the health benefits to be gained. Based on other interventions, policymakers have generally considered costs up to $50,000 or even $100,000 to be worth an extra year of healthy life. In that light, even worst-case estimates for pneumococcal vaccination through age 84 years would be deemed cost-effective.

In 2001, Medicare payments for flu and pneumococcal immunizations totaled $145,885,773. This figure represents Medicare payments for such immunizations furnished in all settings, including, but not limited to, hospitals, nursing homes, and HHAs. Immunization experts working under contract to CMS estimate that implementation of this rule will increase immunization rates by 10 percent. Therefore, we generally estimate that broad implementation of standing orders as allowed by this rule will increase Medicare immunization expenditures by $14,588,577 above the 2001 expenditure.

These cost-effectiveness results provide a compelling case for clinical and public policy to more forcefully promote pneumococcal vaccination for elderly people in the United States. They thus add support on economic grounds to public and private efforts already under way. (JAMA; Oct 22-29; 1997; 278:16)

An alternative would be to keep the present rules, as they are written. The current regulations, however, inhibit our ability to increase the rate of immunizations and to accomplish our goal to immunize at least 90 percent of the institutionalized population.

Another alternative would be to educate providers on the value of influenza and pneumococcal vaccines while maintaining the Federal barrier requiring a physician's order for every vaccine given in these provider types. Studies previously referred to, however, show that this has not been very effective in improving immunization rates.

Increasing the utilization of Medicare-funded preventive services is the goal of both CMS and CDC, and this final rule will facilitate the delivery of appropriate vaccinations in a timely manner, increase the levels of vaccination rate, and decrease the morbidity and mortality rate of influenza and pneumococcal diseases.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

This is a summary of the Commission's Report and Order in IB Docket No. 99-67, FCC 02-134, adopted May 2, 2002 and released on May 14, 2002. In a Notice of Proposed Rulemaking adopted in 1999, 64 FR 16687 (April 6, 1999), the Commission proposed to adopt a new rule section specifying limits on the permissible strength out-of-band emissions from mobile earth stations in order to prevent interference with use of GPS of similar satellite radionavigation services for airplane guidance during approach to landing. After considering relevant public comments, the Commission has decided to adopt the proposed new rule section. The complete text of this decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room), 445 12th Street, SW., Washington, DC 20554, and also may be purchased from the Commission's copy contractor, International Transcription Service, Inc. (ITS, Inc.), 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

This Report and Order requires either new or modified information collections 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 the emergency processing provisions of the PRA. The Commission invites the public and other Federal agencies to comment on information collection(s) required by this Report and Order. Comments should address: (a) Whether the new or modified collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

Public and agency comments on the request for approval of the information collection requirements are due December 2, 2002. All comments regarding the requests for approval of the information collection should be submitted to Judy Boley Herman, Federal Communications Commission, Room 1-C804, 445 12th Street, SW., Washington, DC 20554, or via the Internet to jbHerman@fcc.gov. In addition, comments on the emergency request for approval of the information collections should be submitted to Jeanette Thornton, OMB Desk Officer, Room 10236 NEOB, 725 17th Street, NW., Washington, DC 20503, or via the Internet tojthornto@mb.eop.gov.

The Regulatory Flexibility Act of 1980, as amended (“RFA”), requires a regulatory flexibility analysis to be prepared for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” As required by the RFA, the original Notice of Proposed Rulemaking in this proceeding included an Initial Regulatory Flexibility Analysis (“IRFA”). The Commission invited written public comment on the rulemaking proposal and on the IRFA. This Final Regulatory Flexibility Analysis is also included in compliance with the RFA.

The purpose of this Report and Order is to adopt a rule specifying limits on the permissible strength of emissions produced by mobile earth stations outside their assigned frequency bands, in order to prevent interference with aircraft reception of satellite radionavigation signals in the 1559-1610 MHz band.

None of the comments filed in this proceeding discussed the IRFA.

The RFA directs agencies to provide a description of, and when feasible, an estimate of the number of, small “entities” that may be affected by the rules they adopt. The RFA generally defines the term “small entity” as referring to a “small business,” “small organization,” or “small governmental jurisdiction.” 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).

For satellite telecommunications carriers and resellers, the SBA established a small business size standard that excludes companies with annual receipts in excess of $12.5 million. Ten companies are currently licensed for operation of 1.6 GHz mobile earth stations subject to the rule requirements we are adopting in this order. We have ascertained from published data that four of those companies are not small entities according to the SBA's definition, but we do not have sufficient information to determine which, if any, of the other six are small entities. We anticipate issuing several licenses for 2 GHz mobile earth stations subject to the requirements we are adopting here. We do not know how many of those licenses will be held by small entities, however, as we do not yet know exactly how many 2 GHz mobile-earth-station licenses will be issued or who will receive them.

In this Report and Order, the Commission prescribes limits on the permissible strength of emissions in the 1559-1610 MHz frequency band that may be generated by mobile earth stations with assigned transmission frequencies between 1610 MHz and 1660.5 MHz or between 1990 MHz and 2025 MHz. Those licensed by the Commission to operate, or supervise operation of, such mobile earth stations will be obliged to ensure that the equipment covered by their licenses performs in compliance with the new emission restrictions. Some licensees may find it necessary to alter, replace, or decommission equipment currently in service in order to comply. We do not know, nor do the comments filed in this proceeding indicate, how much expense the pertinent companies may incur to achieve compliance with the new emission limits. The rule we are adopting here does not impose reporting or recordkeeping requirements.

The RFA requires an agency to describe any significant alternatives that it has considered that might reduce economic impact on small entities, such as: establishing different compliance or reporting requirements or timetables that take into account the resources available to small entities; clarifying, consolidating, or simplifying such requirements for small entities; using performance rather than design standards; or completely or partially exempting small entities from new requirements.

We have not considered exempting small entities from the emission limits we are adopting here or prescribing more lenient requirements or compliance timetables for small entities, as we do not believe that such measures could be effected without thwarting fulfillment of our regulatory objective of preventing interference. We have taken steps, however, to minimize adverse impact on affected licensees. Most notably, in the interest of minimizing consequent equipment obsolescence, we have decided to exempt equipment currently in service from full compliance until January 1, 2005.

Report to Congress: The Commission will send a copy of this Report and Order, including a copy of this Final Regulatory Flexibility Analysis (“FRFA”), in a report to Congress pursuant to the Congressional Review Act. The Commission will also send a copy of this Report and Order and FRFA to the Chief Counsel for Advocacy of the SBA, and a copy of the Report and Order and FRFA (or a summary thereof) will be published in the Federal Register .

It is ordered that, pursuant to sections 4(i), 7(a), 303(c), 303(f), 303(g), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 157(a), 303(c), 303(f), 303(g), 303(r), 307, 309(a), 310, part 25 of the Commission's rules is amended, as specified in the rule changes, effective November 1, 2002.

It is further ordered that the Commission's Consumer Information Bureau, Reference Information Center, shall send a copy of this Report and Order the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

Diversified Broadcasting, Inc., licensee of WCJB(TV), Gainesville, Florida (“Diversified”) filed a Petition for Reconsideration of the Memorandum Opinion and Order (“ MO&O ”) in MM Docket No. 00-39, 66 FR 65122 (December 18, 2001), which addressed a number of issues related to the conversion of the nation's broadcast television system from analog to digital television (“DTV”). Specifically, Diversified objects to the determination in the MO&O that certain NTSC applications filed prior to July 1, 1997, must be protected by later-filed DTV area expansion applications. Community Television of Florida, Inc. (“CTF”) filed an Opposition to Diversified's Petition. For the reasons discussed below, the Commission denies Diversified's Petition.

The Report and Order and Further Notice of Proposed Rule Making (“ Report and Order ”), 66 FR 10001 (February 13, 2001), in this proceeding addressed the procedures to be used in processing mutually-exclusive applications filed by licensees seeking to expand or “maximize” their DTV allotments (referred to herein as “expansion applications”). In the Report and Order , we gave processing and protection priority to then pending DTV expansion applications, filed on or prior to January 18, 2001, over previously filed NTSC applications except those NTSC applications that fell into one of three categories: post-auction applications, applications proposed for grant in pending settlements, and singleton applications cut off from further filings. We stated that these applications must have been accepted for filing in order to be protected from DTV expansion applications. When a pending DTV application conflicts with an NTSC application in one of these categories, we stated that we would treat the applications as mutually exclusive (“MX”) and follow the procedures adopted in the Report and Order for MX applications—that is, we required that parties resolve their MX conflict within 90 days or we would subsequently dismiss both applications.

In the MO&O, we revised the procedures for determining priority between conflicting DTV expansion applications and NTSC applications. We noted that in the Broadcast Auctions Report and Order, 63 FR 48615 (September 11, 1998), we had found that, by application of Section 309(l) of the Communications Act, pending NTSC application groups on file prior to July 1, 1997, are entitled to compete in an auction that does not include applications filed on or after July 1, 1997. Pursuant to that statutory directive, we concluded that we may not find DTV expansion applications (all of which were filed after June 30, 1997) to be MX with NTSC application groups on file prior to July 1, 1997. This also is the case when an NTSC application that was cut-off as part of a group of NTSC applications filed before July 1, 1997, has become a singleton because other applications in the group have been dismissed. We concluded in the MO&O that NTSC applications in these two categories—NTSC application groups on file prior to July 1, 1997, and any singletons remaining from such a group—should be protected against DTV expansion applications. DTV expansion applicants are permitted to file minor amendments to resolve conflicts with NTSC applications in these categories.

Diversified requests that we reconsider and reverse our decision that pending DTV expansion applications filed on or prior to January 18, 2001, must protect certain NTSC applications filed prior to July 1, 1997. Diversified argues that we should reinstate our initial decision (in the Report and Order ) and treat these DTV expansion applications as MX with these NTSC applications so that the parties may work together to resolve interference issues. According to Diversified, under the determination in the Report and Order, its DTV expansion application for WCJB(TV) would have been MX with CTF's competing NTSC application for Marianna, Florida, and the parties then would have had 90 days within which to negotiate a resolution to the interference conflict. Under the revised decision in the MO&O, however, the NTSC application for Marianna will take priority, as it was filed prior to July 1, 1997, and was cut-off as part of a group of two competing NTSC applications filed before July 1, 1997. Diversified argues that this processing change puts DTV applicants at a severe disadvantage despite the importance of DTV to the future of television broadcasting. Diversified also argues that we incorrectly interpreted Section 309(l) of the Communications Act, which Diversified claims was intended to resolve exclusivity only among competing analog television applications. According to Diversified, that provision was not intended to address processing of subsequently filed DTV expansion applications, and Congress did not intend that DTV expansion applications be treated as secondary to analog station applications. In its Opposition, CTF argues that Diversified's application must be dismissed as a result of the Commission's decision in the MO&O according priority to NTSC applications filed prior to July 1, 1997.

We decline to revise our determination that Section 309(l) of the Communications Act entitles pending NTSC application groups on file prior to July 1, 1997, to compete in an auction that does not include applications filed on or after July 1, 1997. Section 309(l) provides:

Statutory construction must begin with the language employed by the statute and the assumption that the ordinary meaning of the language accurately expresses the legislative purpose. The language of Section 309(l)(2) is unambiguous that, where competing applications were filed with the Commission before July 1, 1997, “the Commission shall * * * treat the persons filing such applications as the only persons eligible to be qualified bidders.” The Conference Report confirms that “[t]he Commission shall limit the class of eligible applicants who may be considered qualified bidders * * * to the persons who filed applications with the Commission before that date [July 1, 1997].”

In implementing section 309(l) the Commission determined, first, that it would resolve by competitive bidding any mutually exclusive application group not resolved by a settlement agreement and, second, that pending NTSC applications submitted for filing by September 20, 1996 constituted pre-July 1st competing applications within the meaning of section 309(l) even if the related freeze area waiver had not been processed. Except for the circumstance in which only one application (and waiver request) was ever submitted for a particular allotment, the Commission determined that it was precluded by the unambiguous language of subsection (2) from soliciting additional potentially mutually exclusive applications, despite its earlier explicit pledge to provide the opportunity for the filing of competing applications with respect to any analog television application accepted for filing. This interpretation was upheld in Orion Communications, Ltd v. FCC, 221 F.3d 196 (D.C. Cir. 2000) (Table).

Consistent with the determination to resolve competing NTSC applications by competitive bidding and the resulting obligation to insulate such applicants from having to compete for the construction permit against post-June 30, 1997 applicants, the Commission may not require NTSC applications within the scope of section 309(l) to resolve any interference conflicts with pending DTV expansion applicants or face dismissal or otherwise direct that the rights of this category of broadcast applicants are secondary to those of DTV expansion applicants. To do so would vitiate completely the special protections Congress expressly extended to “[c]ompeting applications * * * for commercial radio or television stations filed with the Commission before July 1, 1997.” Congress, although clearly aware in 1997 of the impending transition to DTV, did not offer any guidance either in the statutory language or in the Conference Report as to how the Commission is to accommodate the competing spectrum needs of this group of applicants and of DTV expansion applicants. Even without such express guidance, however, the Commission must devise a solution faithfully effectuating the express protections afforded this category of competing commercial broadcast applications. Notwithstanding Diversified's contention, the Commission's original procedure, requiring the dismissal of certain NTSC applicants within the scope of section 309(l), contravened Congress's manifest intent regarding these particular applicants. Its repeal in the MO&O was therefore compelled by the unambiguous language of section 309(l).

Diversified has advanced no argument that leads us to a different conclusion. Diversified claims that Section 309(l) was intended to resolve mutual exclusivity among analog television applications only, and that it was not intended to determine priority among competing analog and DTV expansion applications. Nothing in the statutory text suggests that DTV expansion applications were intended to be treated differently under Section 309(l), or that they were intended to be treated as MX with applications filed prior to July 1, 1997. Elsewhere in the statute Congress did expressly provide for different treatment of digital stations when, for example, in Section 309(j)(2), it expressly excluded certain digital stations from our competitive bidding authority. Congress made no provision for disparate treatment of DTV expansion applications under Section 309(l), however, and the unambiguous language of that provision compels the result we reached in the MO&O.

The Petition for Reconsideration filed January 17, 2002, by Diversified Broadcasting, Inc. is denied.

An electronic copy of this document may be downloaded by using a computer, modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at 202-512-1661. Internet users may also reach the Office of the Federal Register Web site: http://www.archives.gov/federal_register ; and Government Printing Office Web page: http://www.access.gpo.gov.

Title 49 of the Code of Federal Regulations (CFR), chapter III, subchapter B, contains the Federal Motor Carrier Safety Regulations (FMCSRs) for truck and bus safety. This final rule corrects inaccurate references, citations, and technical errors resulting from statutory changes in laws governing interstate commerce. It also makes other editorial revisions for clarity.

In the § 360.3(f) table, a filing fee has been added for applications involving the merger, transfer, or lease of operating rights of motor passenger and property carriers, property brokers, and household goods freight forwarders under 49 U.S.C. 10321 and 10926. The ICC Termination Act of 1995 (ICCTA) sunsetted the Interstate Commerce Commission (ICC) and transferred the ICC's registration and insurance functions to the Secretary of Transportation, who delegated these functions to the Federal Highway Administration (FHWA) in 1996 and redelegated them to FMCSA in 2000. Filing fees related to these functions were initially assessed under ICC regulations codified in 49 CFR part 1002. In February 1999, FHWA adopted its own filing fee and fee collection regulations in a new part 360 (64 FR 7134, February 12, 1999). The preamble to this rule stated that “(i)n this rulemaking proceeding the FHWA is adopting the ICC's fee regulations related to the recently transferred motor carrier functions without any substantive changes.” However, the rule inadvertently omitted the fee for transfers of operating authority codified at 49 CFR 1002.2(f)(25). Both FHWA and FMCSA have assessed this fee since 1996. Therefore, restoring the transfer fee to the fee table will impose no new burdens on the public.

We are also amending part 360 by revising § 360.3(g)(2) to clarify that a credit card may be required in situations involving dishonored checks.

In part 365, references to water carriers have been removed because the ICCTA did not transfer to the Secretary authority to register water carriers. The ICCTA also required the Secretary to register all freight forwarders, not just household goods freight forwarders. We have changed part 365 to reflect that fact. We have also changed § 365.105(b) to add a reference to FMCSA's do-it-yourself Web site as a means of obtaining OP-1 application forms.

In § 387.39, we have modified two motor carrier financial responsibility forms to correct numerous obsolete references. These forms have been approved by the Office of Management and Budget under control number 2126-0008. Their current expiration date is June 30, 2003.

In § 390.27, the Virgin Islands has been included in the table. In addition, two new notes have been added to direct Canadian and Mexican carriers where to obtain information.

In § 391.41(a), a footnote has been added acknowledging a reciprocity agreement between the United States and Canada that provides for a valid Canadian commercial driver's license issued by a Canadian Province or Territory to be proof of medical fitness to drive commercial motor vehicles (CMVs) in the United States, except in certain limited circumstances.

Finally, a correction has been made to a final rule published on August 9, 2002 (67 FR 51770), pertaining to brake performance requirements for CMVs.

This final rule was issued without using the notice and comment procedures contained at 5 U.S.C. 553(b), because these technical amendments merely correct and clarify existing regulations. They do not impose any new requirements on the regulated industry and are not substantive changes. For the same reasons, good cause exists under 5 U.S.C. 553(d) to dispense with the 30-day delay in the effective date requirement and the FMCSA is making the rule effective upon publication in the Federal Register .

The FMCSA has determined that this action is not a significant regulatory action under Executive Order 12866 or within the meaning of Department of Transportation regulatory policies and procedures. Therefore, this document was not reviewed by the Office of Management and Budget.

These technical amendments will not have an economically significant effect on a substantial number of small entities ( i.e. , motor carriers), and therefore an economic analysis of this rule is not required.

This rule does not impose a Federal mandate resulting in increased expenditures either by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year; nor does it significantly or uniquely affect small governments.

This action meets applicable standards in section 3 of Executive Order 12988 to minimize litigation, eliminate ambiguity, and reduce burden.

This rule is not an economically significant rule and does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045.

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

This final rule will not have federalism implications, as defined in Executive Order 13132, to warrant the preparation of a Federalism Assessment. 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 governments. Nothing in this document directly preempts any State law or regulations.

Catalog of Federal Domestic Assistance Program Number 20.217, Motor Carrier Safety. The regulations implementing Executive Order 12372 regarding intergovernmental consultation of Federal program and activities do not apply to this action.

This final rule does not contain any information collections that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act.

The FMCSA has analyzed this action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ) and has determined that this action does not have any effect on the quality of the environment.

This final rule is exempt from congressional review under 5 U.S.C. 801, because these amendments merely update obsolete references and make minor editorial corrections to existing regulations where applicable.

An emergency rule was recommended by the Pacific Fishery Management Council (Pacific Council) in consultation with Pacific Coast Treaty Tribes and the States of Washington, Oregon, and California at its June 17 - 21, 2002, meeting in Foster City, California. This emergency rule established the DBCA to protect darkblotched rockfish, an overfished species, while allowing limited entry trawl harvest of healthy groundfish stocks outside of the DBCA. The specifications and management measures for the current fishing year (January 1 - December 31, 2002) were initially published in the Federal Register as an emergency rule for January 1 - February 28, 2002 (67 FR 1540, January 11, 2002), and as a proposed rule for all of 2002 (67 FR 1555, January 11, 2002), then finalized effective March 1, 2002 (67 FR 10490, March 7, 2002). The final rule was subsequently amended at 67 FR 15338, April 1, 2002, at 67 FR 18117, April 15, 2002, at 67 FR 30604, May 7, 2002, at 67 FR 40870, June 14, 2002, at 67 FR 44778, July 5, 2002, at 67 FR 48571, July 25, 2002, at 67 FR 50835, August 6, 2002, at 67 FR 55166, August, 28, 2002, and at 67 FR 57973, September 13, 2002.

The new emergency rule in the Pacific Coast groundfish fishery (67 FR 57973, September 13, 2002) published latitude/longitude coordinates for the DBCA in the hundredths of a degree instead of in degrees and minutes. For consistency sake and at the request of the United States Coast Guard, this document re-publishes latitude/longitude coordinates for the DBCA in degrees and minutes.

In the FR Doc. 02-23383 in the issue of Friday, September 13, 2002 (67 FR 57973) make the following corrections:

1. On pages 57975 - 57976, section IV (A) (22) is corrected to read as follows:

(22) Darkblotched Rockfish Conservation Area. There is hereby established a Darkblotched Rockfish Conservation Area (DBCA). The DBCA extends south from the U.S./Canada border (48°30' N. lat.) to 40°10' N. lat. The DBCA is defined along its eastern boundary by straight lines connecting all of the following points in the order stated:

48°14.00' N. lat., 125°36.00' W. long.;

48°8.00' N. lat., 125°38.00' W. long.;

47°57.00' N. lat., 125°30.00' W. long.;

48°20.00' N. lat., 125°18.00' W. long.;

48°20.00' N. lat., 125°3.00' W. long.;

48°23.00' N. lat., 124°50.00' W. long.;

48°17.00' N. lat., 124°56.50' W. long.;

48°6.00' N. lat., 125°0.00' W. long.;

48°9.00' N. lat., 125°18.00' W. long.;

48°6.00' N. lat., 125°18.00' W. long.;

47°59.00' N. lat., 125°16.00' W. long.;

47°49.00' N. lat., 125°3.00' W. long.;

47°42.00' N. lat., 125°4.50' W. long.;

47°31.00' N. lat., 124°54.00' W. long.;

47°24.00' N. lat., 124°46.00' W. long.;

47°18.50' N. lat., 124°45.00' W. long.;

47°8.50' N. lat., 124°56.00' W. long.;

47°0.50' N. lat., 124°54.50' W. long.;

47°1.00' N. lat., 124°58.50' W. long.;

46°57.00' N. lat., 124°54.50' W. long.;

47°0.00' N. lat., 124°49.00' W. long.;

46°54.00' N. lat., 124°48.00' W. long.;

46°54.50' N. lat., 124°52.50' W. long.;

46°41.50' N. lat., 124°43.00' W. long.;

46°34.50' N. lat., 124°28.50' W. long.;

46°29.00' N. lat., 124°30.00' W. long.;

46°20.00' N. lat., 124°36.50' W. long.;

46°18.00' N. lat., 124°38.00' W. long.;

46°17.00' N. lat., 124°35.50' W. long.;

46°17.00' N. lat., 124°22.50' W. long.;

46°16.00' N. lat., 124°20.00' W. long.;

46°12.00' N. lat., 124°35.00' W. long.;

46°10.50' N. lat., 124°39.00' W. long.;

46°8.91' N. lat., 124°39.11' W. long.;

46°0.97' N. lat., 124°38.56' W. long.;

45°57.05' N. lat., 124°36.42' W. long.;

45°54.29' N. lat., 124°40.02' W. long.;

45°47.19' N. lat., 124°35.58' W. long.;

45°41.75' N. lat., 124°28.32' W. long.;

45°34.16' N lat., 124°24.24' W. long.,

45°27.10' N. lat., 124°21.74' W. long.,

45°17.15' N. lat.; 124°17.85' W. long.,

44°59.52' N. lat., 124°19.34' W. long.,

44°49.31' N. lat.; 124°29.97' W. long.,

44°45.64' N. lat., 124°33.89' W. long.;

44°33.00' N. lat., 124°36.88' W. long.;

44°28.21' N. lat., 124°44.72' W. long.;

44°13.17' N. lat., 124°56.36' W. long.;

43°56.34' N. lat., 124°55.74' W. long.;

43°56.47' N. lat., 124°34.61' W. long.;

43°42.73' N. lat., 124°32.41' W. long.;

43°30.93' N. lat., 124°34.43' W. long.;

43°17.45' N. lat., 124°41.16' W. long.;

43°7.04' N. lat., 124°41.25' W. long.;

43°3.45' N. lat., 124°44.36' W. long.;

43°3.90' N. lat., 124°50.81' W. long.;

42°55.70' N. lat., 124°52.79' W. long.;

42°54.12' N. lat., 124°47.36' W. long.;

42°44.00' N. lat., 124°42.38' W. long.;

42°38.23' N. lat., 124°41.25' W. long.;

42°33.03' N. lat., 124°42.38' W. long.;

42°31.90' N. lat., 124°42.04' W. long.;

42°30.09' N. lat., 124°42.67' W. long.;

42°28.28' N. lat., 124°47.08' W. long.;

42°25.22' N. lat., 124°43.51' W. long.;

42°19.23' N. lat., 124°37.92' W. long.;

42°16.29' N. lat., 124°36.11' W. long.;

42°5.66' N. lat., 124°34.92' W. long.;

42°0.00' N. lat., 124°35.27' W. long.;

42°0.16' N. lat., 124°34.70' W. long.;

41°47.04' N. lat., 124°27.65' W. long.;

41°32.92' N. lat., 124°28.79' W. long.;

41°10.12' N. lat., 124°20.50' W. long.;

40°51.37' N. lat., 124°23.39' W. long.;

40°40.73' N. lat., 124°30.37' W. long.;

40°36.05' N. lat., 124°37.09' W. long.;

40°32.64' N. lat., 124°38.48' W. long.;

40°23.30' N. lat., 124°31.60' W. long.;

40°23.93' N. lat., 124°28.05' W. long.;

40°21.99' N. lat., 124°24.01' W. long.;

40°21.10' N. lat., 124°27.87' W. long.;

40°18.67' N. lat., 124°25.99' W. long.;

40°19.05' N. lat., 124°22.53' W. long.;

40°15.02' N. lat., 124°25.76' W. long.;

40°16.55' N. lat., 124°34.01' W. long.; and

40°10.03' N. lat., 124°21.12' W. long.

The DBCA is defined along its western boundary by straight lines connecting all of the following points in the order stated:

48°15.00' N. lat., 125°42.50' W. long.;

48°13.00' N. lat., 125°39.00' W. long.;

48°8.50' N. lat., 125°45.00' W. long.;

48°6.00' N. lat., 125°46.50' W. long.;

48°3.50' N. lat., 125°37.00' W. long.;

48°1.50' N. lat., 125°40.00' W. long.;

47°57.00' N. lat., 125°37.00' W. long.;

47°55.50' N. lat., 125°28.50' W. long.;

47°58.00' N. lat., 125°25.00' W. long.;

48°0.50' N. lat., 125°24.50' W. long.;

48°3.50' N. lat., 125°21.00' W. long.;

48°2.00' N. lat., 125°19.50' W. long.;

48°0.00' N. lat., 125°21.00' W. long.;

47°58.00' N. lat., 125°20.00' W. long.;

47°58.00' N. lat., 125°18.00' W. long.;

47°52.00' N. lat., 125°16.50' W. long.;

47°49.00' N. lat., 125°11.00' W. long.;

47°46.00' N. lat., 125°6.00' W. long.;

47°44.50' N. lat., 125°7.50' W. long.;

47°42.00' N. lat., 125°6.00' W. long.;

47°38.00' N. lat., 125°7.00' W. long.;

47°30.00' N. lat., 125°0.00' W. long.;

47°28.00' N. lat., 124°58.50' W. long.;

47°23.00' N. lat., 124°51.00' W. long.;

47°17.00' N. lat., 124°53.00' W. long.;

47°15.00' N. lat., 125°0.00' W. long.;

47°8.00' N. lat., 124°59.00' W. long.;

47°1.00' N. lat., 125°0.00' W. long.;

46°55.00' N. lat., 125°2.00' W. long.;

46°51.00' N. lat., 124°57.00' W. long.;

46°41.00' N. lat., 124°51.00' W. long.;

46°34.00' N. lat., 124°38.00' W. long.;

46°30.50' N. lat., 124°41.00' W. long.;

46°33.00' N. lat., 124°32.00' W. long.;

46°29.00' N. lat., 124°32.00' W. long.;

46°20.00' N. lat., 124°39.00' W. long.;

46°16.00' N. lat., 124°37.00' W. long.;

46°15.50' N. lat., 124°27.00' W. long.;

46°13.17' N. lat., 124°37.87' W. long.;

46°13.17' N. lat., 124°38.75' W. long.;

46°10.50' N. lat., 124°42.00' W. long.;

46°6.21' N. lat., 124°41.85' W. long.;

46°3.02' N. lat., 124°50.28' W. long.;

45°57.00' N. lat., 124°45.52' W. long.;

45°43.44' N. lat., 124°46.03' W. long.;

45°35.82' N. lat., 124°45.72' W. long.;

45°35.70' N. lat., 124°42.89' W. long.;

45°24.45' N. lat., 124°38.21' W. long.;

45°11.68' N. lat., 124°39.38' W. long.;

44°57.94' N. lat., 124°37.02' W. long.;

44°44.28' N. lat., 124°50.79' W. long.;

44°32.63' N. lat., 124°54.21' W. long.;

44°23.20' N. lat., 124°49.87' W. long.;

44°13.18' N. lat., 124°58.81' W. long.;

43°57.92' N. lat., 124°58.29' W. long.;

43°50.12' N. lat., 124°53.36' W. long.;

43°49.53' N. lat., 124°43.96' W. long.;

43°42.76' N. lat., 124°41.40' W. long.;

43°24.00' N. lat., 124°42.61' W. long.;

43°19.74' N. lat., 124°45.12' W. long.;

43°19.63' N. lat., 124°52.95' W. long.;

43°17.41' N. lat., 124°53.02' W. long.;

42°49.15' N. lat., 124°54.93' W. long.;

42°46.74' N. lat., 124°53.39' W. long.;

42°43.76' N. lat., 124°51.64' W. long.;

42°45.41' N. lat., 124°49.35' W. long.;

42°43.92' N. lat., 124°45.92' W. long.;

42°38.87' N. lat., 124°43.38' W. long.;

42°34.78' N. lat., 124°46.56' W. long.;

42°31.47' N. lat., 124°46.89' W. long.;

42°31.00' N. lat., 124°44.28' W. long.;

42°29.22' N. lat., 124°46.93' W. long.;

42°28.39' N. lat., 124°49.94' W. long.;

42°26.28' N. lat., 124°47.60' W. long.;

42°19.58' N. lat., 124°43.21' W. long.;

42°13.75' N. lat., 124°40.06' W. long.;

42°5.12' N. lat., 124°39.06' W. long.;

41°59.99' N. lat., 124°37.72' W. long.;

41°59.33' N. lat., 124°37.68' W. long.;

41°47.93' N. lat., 124°31.79' W. long.;

41°21.35' N. lat., 124°30.35' W. long.;

41°7.11' N. lat., 124°25.25' W. long.;

41°7.12' N. lat., 124°25.05' W. long.;

40°57.37' N. lat., 124°30.25' W. long.;

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

Within any fishing year, underage or overage of a seasonal allowance may be added to or subtracted from subsequent seasonal allowances in a manner to be determined by the Administrator, Alaska Region, NMFS (Regional Administrator), provided that the sum of the revised seasonal allowances does not exceed 30 percent of the annual TAC apportionment for the Central and Western Regulatory Areas in the GOA (§ 679.20(a)(5)(ii)(C)). For 2002, 30 percent of the annual TAC for the Central and Western Regulatory Areas is 15,187 mt. For 2002, the Regional Administrator has determined that within each area for which a seasonal allowance is established, any overage or underage of harvest from the previous season(s) shall be subtracted from or added to the seasonal allowance of the following season provided that the resulting sum of seasonal allowances in the Central and Western Regulatory Areas does not exceed 15,187 mt in any single season. The D season allowance of the pollock TAC in Statistical Area 630 is 3,803 metric tons (mt) as established by an emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002 and 67 FR 34860, May 16, 2002). The C season allowance in Statistical Area 630 was exceeded by 2,855 mt, therefore the Regional Administrator, in accordance with § 679.20(a)(5)(ii)(C), is reducing the D season pollock TAC in Statistical Area 630 by 2,855 mt to 948 mt.

In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the D season allowance of the pollock TAC in Statistical Area 630 will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 908 mt, and is setting aside the remaining 40 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will soon be reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 630.

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

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the closure of the fishery, lead to exceeding the TAC, and therefore reduce the public's ability to use and enjoy the fishery resource.The Assistant Administrator for Fisheries, NOAA, also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.This action is required by § 679.20 and is exempt from review under Executive Order 12866.

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

The emergency rule implementing the 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002, and 67 FR 34860, May 16, 2002) established the amount of the 2002 BSAI Pacific cod TAC as 185,000 metric tons (mt) after subtraction of the community development quota (CDQ) reserves and apportionment of the reserve. Pursuant to § 679.20(a)(7)(i)(A), 3,700 mt was allocated to vessels using jig gear, 94,350 mt to vessels using hook-and-line or pot gear, and 86,950 mt to vessels using trawl gear. The share of the Pacific cod TAC allocated to trawl gear was further allocated 50 percent to catcher vessels and 50 percent to catcher/processor vessels (§ 679.20(a)(7)(i)(B)). The share of the Pacific cod TAC allocated to hook-and-line or pot gear was further allocated (i) 80 percent to catcher/processor vessels using hook-and-line gear; (ii) 0.3 percent to catcher vessels using hook-and-line gear; (iii) 18.3 percent to vessels using pot gear; and (iv) 1.4 percent to catcher vessels less than 60 ft length overall (18.3 m) that use either hook-and-line or pot gear (§ 679.20(a)(7)(i)(C)).

As of September 7, 2002, the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that trawl catcher/processors will not be able to harvest 3,000 mt and trawl catcher vessels will not be able to harvest 1,000 mt of Pacific cod allocated to those vessels under § 679.20(a)(7)(i)(B). Therefore, in accordance with § 679.20(a)(7)(ii)(C), NMFS apportions 4,000 mt of Pacific cod from trawl gear to vessels using hook-and-line or pot gear.

The Regional Administrator also has determined that vessels using jig gear will not harvest 3,400 mt of their Pacific cod allocation by the end of the year. Therefore, in accordance with § 679.20(a)(7)(ii)(C), NMFS is reallocating the unused amount of 3,400 mt of Pacific cod allocated to vessels using jig gear to vessels using hook-and-line or pot gear.

In accordance with § 679.20(a)(7)(ii)(C)(1), 200 mt of the combined reallocation of unused Pacific cod from trawl and jig gear is apportioned to catcher vessels using hook-and-line gear. In accordance with § 679.20(a)(7)(ii)(C)(2), the remaining combined reallocation of unused Pacific cod from trawl and jig gear, 7,200 mt, is apportioned so that catcher/processor vessels using hook-and-line gear will receive 95 percent and vessels using pot gear will receive 5 percent of the reallocation.

The harvest specifications for Pacific cod established by the emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002, and 67 FR 34860, May 16, 2002) are revised as follows: 300 mt to vessels using jig gear, 81,920 mt to catcher processor vessels using hook-and-line gear, 482 mt to catcher vessels using hook-and-line gear, 17,535 mt to pot gear, 40,475 mt to trawl catcher/processors, and 42,475 mt to trawl catcher vessels.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the implementation of these measures in a timely fashion in order to allow full utilization of the Pacific cod TAC, and therefore reduce the public's ability to use and enjoy the fishery resource.

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

This action is taken under 50 CFR 679.20 and is exempt from OMB review under Executive Order 12866.

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

The 2002 Atka mackerel TAC in the Central Aleutian District of the BSAI is 22,015 metric tons (mt) as established by an emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002, and 67 FR 34860, May 16, 2002).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2002 Atka mackerel TAC in the Central Aleutian District will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 21,615 mt, and is setting aside the remaining 400 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will soon be reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the Central Aleutian District of the BSAI.

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

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

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

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