This rule is issued under Marketing Agreement No. 84 and Marketing Order No. 905, both as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule changes the rules and regulations under the order to exempt shipments of small quantities of tree run citrus from grade, size, and assessment requirements. Tree run citrus is wholesome citrus picked and boxed in the field and taken directly to market without being graded or sized. With this change, producers are allowed to ship 150 1 3/5 bushel boxes per variety, per shipment, of their own citrus free from marketing order regulations. Total shipments cannot exceed 1,500 boxes per variety for the season. This action was unanimously recommended by the committee at its meeting held on May 22, 2002.

Section 905.80 of the marketing order provides authority for the Committee to exempt certain types of shipments from regulation. Exemptions can be implemented for types of shipments of any variety in such minimum quantities, or for such purposes as the committee with the approval of USDA may specify. No assessment is levied on fruit so shipped. The committee shall, with the approval of USDA, prescribe such rules, regulations, or safeguards as it deems necessary to prevent varieties handled under the provisions of this section from entering channels of trade for other than the purposes authorized by this section.

This rule adds section 905.149 to the rules and regulations under the order. This section defines grower tree run citrus and outlines the procedures to be used for growers to apply to the committee to ship their own tree run citrus fruit exempt from grade, size, and assessment requirements under the order. Under this section, once the exemption has been approved, the grower must report to the committee the volume of fruit shipped, the date of the shipment, and type of transportation used.

According to Florida Department of Citrus (FDOC) regulation 20-35.006, “Tree run grade is that grade of naturally occurring sound and wholesome citrus fruit which has not been separated either as to grade or size after severance from the tree.” Also, FDOC regulation 20-62.002 defines wholesomeness as fruit free from rot, decay, sponginess, unsoundness, leakage, staleness, or other conditions showing physical defects of the fruit. By definition, this fruit is handled by the grower and bypasses normal handler operations. Prior to this change, all tree run citrus had to meet all requirements of the marketing order, as well as State of Florida Statutes and Florida Department of Citrus regulations. Even with this change, tree run citrus must continue to meet applicable State of Florida Statutes and Florida Department of Citrus regulations, including inspection. Growers will be able to pick, box, and ship directly to buyers, and avoid the costs incurred when citrus is handled by packinghouses.

Over the past few years, small producers of Florida citrus have expressed concerns regarding problems incurred when selling their citrus. These concerns include costs, returns, and available markets. These problems, along with market conditions, have driven a fair number of citrus growers and handlers out of the citrus industry. These concerns have been discussed at committee meetings, as well as meetings of other industry groups.

Some small growers have stated they have had difficulty getting packinghouses to pack their fruit. There is limited demand for certain varieties of citrus produced. In some cases, supply exceeds demand in the standard markets. According to committee data, over the past five years, fresh grapefruit sales have dropped 25 percent and fresh orange shipments are down 11 percent. In some cases, varieties may be out of favor with handlers and consumers, or there may be a glut on the market of a particular variety of fruit. As a result, packinghouses do not wish to become over stocked with fruit which is difficult to market and, therefore, will not pack less popular minor varieties of fruit or fruit that is in oversupply. Packinghouses do not want to pack what they cannot sell. These factors have caused wholesome fruit to be shipped to processing plants or left on the tree.

The costs of growing for the fresh market have been increasing, while, in many cases the returns to the grower have been decreasing. The cost of picking, packing, and hauling, and associated handling costs for fruit going to the fresh market, is sometimes greater than the grower's return on the fruit. The costs associated with growing for the fresh market are greater than the costs for growing for the processed market.

When citrus cannot be sold into the fresh market, it can be sold to the processing plants. However, the prices received are considerably lower. For example, during the last five years, only the 1999-2000 season produced on-tree returns for processed red seedless grapefruit that exceeded one dollar per box. Over the period from 1977 through 2000, the differential between fresh prices and processed prices has averaged $3.55 per box. The average on-tree price for processed Florida oranges during the 2000-01 season was $2.72 compared to $4.25 for fresh oranges.

In some cases, where the cost of harvesting citrus exceeds the returns to the grower or the grower cannot find a buyer for the fruit, economic abandonment can occur. According to information from the National Agricultural Statistics Service, the seasons of 1995-96, 1996-97, 1997-98, and 2000-01 had an average economic abandonment of two million boxes or more of red seedless grapefruit alone.

Consequently, growers are looking for other outlets to move their fruit in an effort to increase returns. Several growers at the meeting stated regulations imposed on the citrus industry have made it difficult for them to ship homegrown fruit into interstate markets. Some growers believe secondary markets exist which are not currently being supplied that would provide them an additional outlet to sell their citrus. They think niche markets exist that could be profitable if they were given the opportunity to reach them. They believe they can ship quality fruit directly to out-of-state markets and that it would be well received.

Growers want the opportunity to pursue those niche markets. These growers contend tree run citrus does not need a minimum grade and size to be marketable, and that they can supply quality fruit to secondary markets not served by packed fruit. However, they believe to do it profitably, they need to bypass the normal handler operations and the associated costs.

The committee listened to the concerns of these small growers and the problems they have encountered. In an effort to allow these growers to pursue these niche markets, the committee, which consists of growers and handlers, unanimously voted to allow a minimum quantity of citrus to be shipped exempt from the grade, size, and assessment regulations. The committee recommended growers be allowed to ship up to 150 1 3/5 bushel boxes of each variety, per shipment, from their own groves, with total shipments for the season not to exceed 1,500 boxes per variety.

Throughout industry discussions, many different combinations of varieties and shipment totals were discussed. In making this recommendation, the committee determined that 150 boxes of each variety per shipment will allow the grower to ship a sufficient amount of fruit to make the exemption cost effective and yet not allow too much fruit to enter market channels exempt from marketing order requirements. The committee believes this level of volume will help keep this fruit in non-competitive outlets.

The committee believes this tree run fruit will be sold primarily to non-competitive, niche markets, such as farmers' markets, flea markets, roadside stands, and similar outlets and will not compete with non-exempt fruit shipped under the order. Fruit is sold in similar markets within the state, and such markets have been successful. This change allows growers to sell directly to similar markets outside of the state. The committee believes this action will allow the industry to service more non-traditional markets and that this may be a way to increase fresh market shipments and develop new markets. Granting this exemption will allow growers to supply markets that might not otherwise be supplied. Some members expect that this tree run or grove fresh fruit may create greater consumer interest in fresh citrus fruit.

Under this provision, the grower is required to apply to the committee, on a “Grower Tree Run Certificate Application” form provided by the committee, for an exemption to ship tree run citrus fruit to interstate markets. On this form, the grower must provide the committee with their name; address; phone number; legal description of the grove; variety of citrus to be shipped; and the approximate number of boxes produced on the specified grove. The grower must also certify that the fruit to be handled comes from the grove owned by the grower applicant. The grower will report to the committee the actual number of boxes per variety shipped under the exemption on the shipment form discussed below.

The Grower Tree Run Certificate Application form will be submitted to the committee manager. The manager will review the application for completeness and accuracy. The manager will also verify the information provided. After the application has been reviewed, the manager will notify the grower applicant in writing whether the application is approved or denied.

Once the grower has received approval for their application for exemption and begins shipping fruit, a “Report of Shipments Under Grower Tree Run Certificate” form, also provided by the committee, must be completed for each shipment. On this form, the grower will provide the location of the grove, the amount of fruit shipped, the shipping date, and the type of transportation used to ship the fruit, along with the vehicle license number. The grower must supply the Road Guard Station with a copy of the grower certificate report for each shipment, and provide a copy of the report to the committee. This report will enable the committee to maintain compliance and gather data, which will be used to determine the effectiveness of the exemption. Failure to comply with these requirements may result in the cancellation of a grower's certificate.

The FDOC defines tree run grade and wholesomeness of citrus fruit. This fruit is handled by the grower and bypasses normal handler operations. Even with the change to the provisions under the order, tree run citrus must still meet the requirements of the State of Florida Statutes and FDOC regulations, including inspection. Consequently, growers will continue to need to have the fruit inspected to meet current State requirements.

This exemption will be effective for the current season, beginning with the effective date of this rule, and ending July 1, 2003, only. The committee determined that offering the exemption for one season will provide sufficient information on how the fruit shipped under the exemption was received on the market. It will also indicate whether or not other markets exist that packed fruit is not currently supplying, where these markets are located, and approximately how much fruit can be sold in such markets. It will also indicate the number of growers interested in utilizing the exemption and the volume of citrus shipped under the exemption. In addition, it will provide the committee with information regarding any potential impact on competitive outlets. The committee will also have information available regarding any compliance issues not previously discussed. At the end of the season, the committee will review all available information and decide whether the exemption should be continued.

This rule does not affect the provision that handlers may ship up to 15 standard packed cartons (12 bushels) of fruit per day exempt from regulatory requirements. Fruit shipped in gift packages that are individually addressed and not for resale, and fruit shipped for animal feed are also exempt from handling requirements under specific conditions. Also, fruit shipped to commercial processors for conversion into canned or frozen products or into a beverage base are not subject to the handling requirements under the order.

Section 8e of the Act requires that whenever grade, size, quality, or maturity requirements are in effect for certain commodities under a domestic marketing order, including citrus, imports of that commodity must meet the same or comparable requirements. This rule does not change the minimum grade and size requirements under the order. Therefore, no change is necessary in the citrus import regulations as a result of this action.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 11,000 producers of Florida citrus in the production area and approximately 80 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

Based on industry and committee data, the average annual f.o.b. price for fresh Florida citrus during the 2000-01 season was approximately $8.10 per 4/5 -bushel carton for all shipments, and the total fresh shipments for the 2000-01 season are estimated at 53.5 million 4/5 -bushel cartons of Florida citrus. Approximately 50 percent of the handlers handled 93 percent of Florida citrus shipments. Using information provided by the committee, about 60 percent of citrus handlers could be considered small businesses under the SBA definition. Although specific data is unavailable, the Department believes that the majority of Florida citrus producers may be classified as small entities.

This rule adds a § 905.149 to the rules and regulations under the order to exempt shipments of small quantities of tree run citrus from the grade, size, and assessment requirements of the order. This action allows growers to ship 150 1 3/5 bushel boxes per variety, per shipment, of their own tree run citrus free from marketing order regulations into interstate markets. Total shipments cannot exceed 1,500 boxes per variety for the season per individual grower. This change is effective for the 2002-03 season only. The committee believes this action may be a way to increase fresh market shipments, develop new markets, and improve grower returns. Authority for this action is provided in § 905.80(e).

According to a recent study by the University of Florida—Institute of Food and Agricultural Sciences, production costs for the 2001-02 season ranged from $1.71 per box for processed oranges to $2.41 per box for grapefruit grown for the fresh market. The average packing charge for oranges is approximately $6.50 per box, for grapefruit the charge is approximately $5.75 per box, and for tangerines the charge can be as high as $9 per box. In a time when grower returns are weak, sending fruit to a packinghouse can be cost prohibitive, especially for the small grower. This rule may provide an additional outlet for fruit that might otherwise be forced into the processing market or left on the tree altogether.

This rule will not impose any additional costs on the grower. This rule has the opposite effect, reducing the costs associated with having fruit handled by a packinghouse. This rule will enable growers to ship their tree run citrus free from grade, size, and assessment requirements under the order. This action will allow growers to ship minimum quantities of their citrus directly into interstate commerce exempt from some order requirements and their related costs. With this action, growers will be able to reduce handling costs and use those savings toward developing additional markets. This will benefit all growers regardless of size but it is expected to have a particular benefit for the small grower.

The committee considered several alternatives to this action, including making no change to the current regulations. The committee believed that some change was necessary to help Florida citrus growers. The committee considered allowing growers to ship unlimited quantities of any grower's citrus. This option was rejected because it would have caused market disruption and compliance problems, as growers could become shippers for other growers. It would have also made it more difficult to keep this fruit in noncompetitive outlets. Other alternatives considered were increasing the number of boxes available to be shipped per load, and increasing the number of boxes available to be shipped per season. These options were also rejected amid concerns that too much fruit could be shipped and find its way into the competitive markets.

USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

Further, the committee's meeting was widely publicized throughout the citrus industry and all interested persons were invited to attend the meeting and participate in committee deliberations. Like all committee meetings, the May 22, 2002, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.

Also, the committee has a number of appointed subcommittees to review certain issues and make recommendations to the committee. A subcommittee met May 21, 2002, and discussed the tree run issue in detail. That meeting was also a public meeting and both large and small entities were able to participate and express their views. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html . Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

This action requires two additional forms. These information collection requirements are discussed in the following section.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces that AMS is requesting emergency approval for a new information collection request for Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida, Marketing Order No. 905. The emergency request is necessary because insufficient time is available to follow normal clearance procedures.

Title: Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida, Marketing Order No. 905.

OMB Number: 0581-NEW.

Type of Request: New collection.

Abstract: The information collection requirements in this request are essential to carry out the intent of the Act, to provide the respondents the type of service they request, and to administer the Florida citrus marketing order program, which has been operating since 1939.

On May 22, 2002, the committee unanimously recommended revising the order's administrative rules and regulations to exempt a small volume of a grower's tree run fruit from certain order requirements and to require producers to apply to the committee for such an exemption and to report to the committee information on their shipments under the exemption. This information will be reported on two new committee forms. Form CAC 401 , Grower Tree Run Certificate Application , is used by growers to apply for an exemption to ship their own tree run Florida citrus fruit during the season. Form CAC 402 , Report of Shipments Under Grower Tree Run Certificate , is used by growers to inform the committee of their tree run shipments during the regulation period.

The new reports are needed so the committee can collect information on the number of growers shipping their own tree run Florida citrus fruit into interstate commerce during the regulation period, and information on the volume of tree run fruit shipped. The committee will evaluate this information and determine whether a grower is in compliance with the regulation. These reports will ensure compliance with the regulations and assist the committee and the USDA with oversight and planning.

The information collected is used only by authorized representatives of USDA, including AMS, Fruit and Vegetable Programs regional and headquarters staff, and authorized committee employees. Authorized committee employees will be the primary users of the information and AMS would be the secondary user.

The request for approval of the new information collections under the order is as follows:

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 5 minutes per response.

Respondents: Growers applying to ship their own tree run Florida citrus fruit during the 2002-03 season.

Estimated Number of Respondents: 45.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 3.74 hours.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 5 minutes per response.

Respondents: Growers who handle their own tree run Florida citrus fruit during the regulation period.

Estimated Number of Respondents: 45.

Estimated Number of Responses per Respondent: 3.

Estimated Total Annual Burden on Respondents: 11.21 hours.

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments should reference OMB No. 0581-NEW and the Florida citrus marketing order, and be sent to USDA in care of the Docket Clerk at the previously mentioned address. All comments received will be available for public inspection during regular business hours at the same address.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. As mentioned before, because there is insufficient time for a normal clearance procedure and prompt implementation is needed, AMS is seeking emergency approval from OMB for the use of the two new forms for the 2002-03 regulation period. Upon OMB approval, the forms will be merged with the forms currently approved under OMB No. 0581-0189, “Generic OMB Fruit Crops.” As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

In addition to this change in the information collection burden, this rule exempts grower owned, tree run, Florida citrus fruit from some of the rules and regulations under the order. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the committee's recommendation, and other information, it is found that this interim final rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register . This rule needs to be in place as soon as possible to cover as many shipments during the 2002-03 season as possible. Also, growers need to know they are free to market their citrus under these exemption procedures. In addition, this issue has been widely discussed at various industry and association meetings, and the committee has kept the industry well informed. Interested persons have had time to determine and express their positions. Further, growers and handlers are aware of this rule, which was recommended at public meetings. Also, a 60-day comment period is provided for in this rule.

This rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, orange and grapefruit handlers in the Lower Rio Grande Valley in Texas are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable oranges and grapefruit beginning on August 1, 2002, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule decreases the assessment rate established for the Committee for the 2002-03 and subsequent fiscal periods from $0.12 to $0.11 per 7/10 -bushel carton of oranges and grapefruit.

The Texas orange and grapefruit marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of Texas oranges and grapefruit. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 1999-2000 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on May 30, 2002, and unanimously recommended 2002-03 expenditures of $1,226,022 and an assessment rate of $0.12 per 7/10 -bushel carton of oranges and grapefruit. The Committee met again on August 28, 2002, and recommended a decreased assessment rate of $0.11, with no change to the previously approved budget of $1,226,022. Thirteen of the 14 Committee members and alternates acting as members voted in support of the $0.11 per 7/10 -bushel carton decrease. One Committee member voted against the decrease. In comparison, last year's budgeted expenditures were $1,236,777. The assessment rate of $0.11 is $0.01 lower than the rate currently in effect. The Committee voted to reduce the assessment rate after determining that its reserve fund was higher than they believed necessary, and to lower handler assessment costs for 2002-03 by $100,000.

The major expenditures recommended by the Committee for the 2002-03 fiscal period include $810,500 for advertising, $179,000 for the Mexican Fruit Fly program, $107,845 for management and administration of the program, and $74,777 for compliance. Budgeted expenses for these items in 2001-02 were $810,500, $197,000, $104,500, and $74,777, respectively.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Texas oranges and grapefruit. Texas orange and grapefruit shipments for the year are estimated at 10 million 7/10 -bushel cartons, which should provide $1,100,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, will be adequate to cover budgeted expenses. Funds in the reserve (currently $274,041) will be kept within the maximum of one fiscal period's expenses permitted by the order (§ 906.35).

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2002-03 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 410 producers of oranges and grapefruit in the production area and approximately 15 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

An updated Texas citrus industry profile shows that 6 of the 15 handlers (40 percent) shipped over 651,042 7/10 -bushel cartons of oranges and grapefruit. Using an average f.o.b. price of $7.68 per 7/10 -bushel carton, these handlers could be considered large businesses under SBA's definition, and the remaining 9 handlers (60 percent) could be considered small businesses. Of the approximately 410 producers within the production area, few have sufficient acreage to generate sales in excess of $750,000. Thus, the majority of handlers and producers of Texas oranges and grapefruit may be classified as small entities.

This rule decreases the assessment rate established for the Committee and collected from handlers for the 2002-03 and subsequent fiscal periods from $0.12 to $0.11 per 7/10 -bushel carton of oranges and grapefruit. The Committee recommended 2002-03 expenditures of $1,226,022 and an assessment rate of $0.11 per 7/10 -bushel carton of oranges and grapefruit. The recommended assessment rate of $0.11 is $0.01 lower than the current rate. The quantity of assessable oranges and grapefruit for the 2002-03 fiscal year is estimated at 10 million cartons. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, will be adequate to cover budgeted expenses.

The major expenditures recommended by the Committee for the 2002-03 fiscal period include $810,500 for advertising, $179,000 for the Mexican Fruit Fly program, $107,845 for management and administration of the program, and $74,777 for compliance. Budgeted expenses for these items in 2001-02 were $810,500, $197,000, $104,500, and $74,777, respectively.

The Committee recommended the $0.11 assessment rate to lower its operating reserve to $171,249. With a $0.12 assessment rate, the Committee projected its reserve on July 31, 2003, to be $271,249, and it thought that was higher than needed to administer the program. It also recommended the reduced rate to lower handler assessments by $100,000 during 2002-03.

The Committee reviewed and unanimously recommended 2002-03 expenditures of $1,226,022, which included a decrease in the Mexican Fruit Fly program and an increase in the management and administration of the program. Budgeted expenses for the advertising program and the compliance program remained the same as last year. In arriving at the budget, the Committee considered information from various sources, including the Executive Committee. The Committee considered leaving the established higher assessment rate unchanged. However, it concluded that the reserves currently held by the Committee are higher than the Committee needs to administer the program.

The proposed assessment rate of $0.11 per 7/10 -bushel carton of assessable oranges and grapefruit was determined by dividing the total budget by the 10 million 7/10 -bushel cartons of oranges and grapefruit estimated for the 2002-03 fiscal period. The $0.11 rate will provide $1,100,000 in assessment income. The additional $126,022 to fund the Committees estimated expenses will come from the Committee's reserve, a refund of an overpayment from the Mexican Fruit Fly program, and interest income.

A review of historical information (October 1998 through May 2002) and preliminary information pertaining to the upcoming fiscal period indicates that the packinghouse door price for the 2002-03 fiscal period could range, monthly, from $1.65 to $10.36 per 7/10 -bushel carton of Texas oranges and grapefruit, depending upon the fruit variety, size, and quality. Therefore, the estimated assessment revenue for the 2002-03 fiscal period as a percentage of total grower (packinghouse door) revenue could range between 6.67 percent and 1.06 percent.

This action decreases the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the Committee's meeting was widely publicized throughout the Texas orange and grapefruit industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the August 28, 2002, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

This action imposes no additional reporting or recordkeeping requirements on either small or large Texas orange and grapefruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html . Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2002-03 fiscal period began on August 1, 2002, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable oranges and grapefruit handled during such fiscal period; (2) this action decreases the assessment rate for assessable oranges and grapefruit beginning with the 2002-03 fiscal period; (3) handlers are aware of this action which was recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years; and (4) this interim final rule provides a 60-day comment period, and all comments timely received will be considered prior to finalization of this rule.

This rule is issued under Marketing Order No. 920, as amended (7 CFR part 920), regulating the handling of kiwifruit grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California kiwifruit handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable kiwifruit beginning on August 1, 2002, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule increases the assessment rate established for the Committee for the 2002-03 and subsequent fiscal periods from $0.03 to $0.045 per 22-pound volume fill container or equivalent of kiwifruit.

The California kiwifruit marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers of California kiwifruit. They are familiar with the Committee's needs and the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed at a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2000-01 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on July 10, 2002, and unanimously recommended 2002-03 expenditures of $80,760 and an assessment rate of $0.045 per 22-pound volume fill container or equivalent of kiwifruit. In comparison, last year's budgeted expenditures were $78,000. The assessment rate of $0.045 is $0.015 higher than the rate currently in effect. The higher assessment rate is needed to offset the 2002-03 increase in salaries and vehicle expenses, and to keep the operating reserve at an adequate level.

The following table compares major budget expenditures recommended by the Committee for the 2002-03 and 2001-02 fiscal periods:

The assessment rate recommended by the Committee was derived using the following formula: Anticipated expenses ($80,760), plus the desired 2003 ending reserve ($36,287), minus the 2002 beginning reserve ($23,979), divided by the total estimated 2002-03 shipments (2,068,182 22-pound volume fill containers). This calculation resulted in the $0.045 assessment rate. This rate will provide sufficient funds to meet the anticipated expenses of $80,760 and result in a July 2003 ending reserve of $36,287, which is acceptable to the Committee. The July 2003 ending reserve funds (estimated to be $36,287) will be within the maximum permitted by the order, approximately one fiscal period's expenses (§ 920.41).

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2002-03 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 326 producers of kiwifruit in the production area and approximately 52 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

None of the 52 handlers subject to regulation have annual kiwifruit sales of at least $5,000,000. Two of the 326 producers subject to regulation have annual sales of at least $750,000. Thus, the majority of handlers and producers of kiwifruit may be classified as small entities.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2002-03 and subsequent fiscal periods from $0.03 to $0.045 per 22-pound volume fill container or equivalent of kiwifruit. The Committee unanimously recommended 2002-03 expenditures of $80,760 and an assessment rate of $0.045 per 22-pound volume fill container or equivalent of kiwifruit. The assessment rate of $0.045 is $0.015 higher than the 2001-02 rate. The quantity of assessable kiwifruit for the 2002-03 fiscal period is estimated at 2,068,182 22-pound volume fill container or equivalent of kiwifruit. Thus, the $0.045 rate should provide $93,068 in assessment income and be adequate to meet this year's expenses.

The following table compares major budget expenditures recommended by the Committee for the 2002-03 and 2001-02 fiscal years:

The Committee reviewed and unanimously recommended 2002-03 expenditures of $80,760, which included increases in administrative salaries and vehicle expenses. Prior to arriving at this budget, the Committee considered alternative expenditure levels, but ultimately decided that the recommended levels were reasonable to properly administer the order. The assessment rate recommended by the Committee was derived using the following formula: Anticipated expenses ($80,760), plus the desired 2003 ending reserve ($36,287), minus the 2002 beginning reserve ($23,979), divided by the total estimated 2002-03 shipments (2,068,182 22-pound volume fill containers). This calculation resulted in the $0.045 assessment rate. This rate will provide sufficient funds to meet the anticipated expenses of $80,760 and result in a July 2003 ending reserve of $36,287, which is acceptable to the Committee. The July 2003 ending reserve funds (estimated to be $36,287) will be within the maximum permitted by the order, approximately one fiscal period's expenses (§ 920.41).

A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the grower price for the 2002-03 season could range between $9.50 and $13.00 per 22-pound volume fill container or equivalent of kiwifruit. Therefore, the estimated assessment revenue for the 2002-03 fiscal period as a percentage of total grower revenue could range between 0.5 and 0.3 percent.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs will be offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the California kiwifruit industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the July 10, 2002, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

This rule imposes no additional reporting or recordkeeping requirements on either small or large California kiwifruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

A proposed rule concerning this action was published in the Federal Register on August 15, 2002 (67 FR 53322). Copies of the proposed rule were also mailed or sent via facsimile to all California kiwifruit handlers. Finally, the proposal was made available through the Internet by the Office of the Federal Register and USDA. A 30-day comment period ending September 16, 2002, was provided for interested persons to respond to the proposal. No comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it also 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 because: (1) Handlers are already receiving the 2002-03 kiwifruit crop and the marketing order requires that the rate of assessment apply to all assessable kiwifruit handled during the 2002-03 and subsequent seasons; (2) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years. Also, a 30-day comment period was provided for in the proposed rule, and no comments were received.

Section 196 of the Federal Agriculture Improvement Act of 1996 (1996 Act) is the statutory authority for NAP. Section 10101 of the 2002 Act amended section 196 to provide for the new crop eligibility implemented by this rule. Section 161 of the 1996 Act requires that the provisions of Title I of the 1996 Act, which includes section 196, be issued without regard to the notice and comment provisions of 5 U.S.C. 553 or the Statement of Policy of the Secretary of Agriculture effective July 24, 1971, (36 FR 13804) relating to notices of proposed rulemaking and public participation in rulemaking. These regulations are thus issued as final.

This final rule has been determined to be not significant under Executive Order 12866 and therefore has not been reviewed by the Office of Management and Budget (OMB).

The title and number of the Federal assistance program, as found in the Catalog of Federal Domestic Assistance, to which this final rule applies are:

Noninsured Crop Disaster Assistance—10.451.

The Regulatory Flexibility Act is not applicable to this rule because neither the Secretary of Agriculture nor CCC are required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule.

The environmental impacts of this rule have been considered in accordance with the provisions of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq. , the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and FSA's regulations for compliance with NEPA, 7 CFR part 799. FSA has concluded that this rule is categorically excluded from further environmental review and documentation as evidenced by the completion of an environmental evaluation. No extraordinary circumstances or other unforeseeable factors exist which would require preparation of an environmental assessment or environmental impact statement. A copy of the environmental evaluation is available for inspection and review upon request.

The final rule has been reviewed in accordance with Executive Order 12778. This final rule preempts State laws to the extent such laws are inconsistent with the provisions of this rule. The provisions of this rule are not retroactive. Before any judicial action may be brought concerning the provisions of this rule, the administrative remedies must be exhausted.

This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115 (June 24, 1983).

The provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) do not apply to this rule because neither the Secretary of Agriculture nor CCC are required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule. Also, the rule imposes no mandates as defined in UMRA.

Section 196 of the 1996 Act requires that these regulations be issued without regard to the Paperwork Reduction Act. This means that the normal 60-day public comment period and OMB approval of the information collections required by this rule are not necessary before the regulations may be made effective. However, FSA will still request approval of the new information collections required by this rule.

CCC and FSA are committed to compliance with the Government Paperwork Elimination Act (GPEA) and the Freedom to E-File Act, which require Government agencies in general, and FSA in particular, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. The forms and other information collection activities required by participation in the Noninsured Crop Disaster Assistance Program are not yet fully implemented in a way that would allow the public to conduct business with FSA electronically. Accordingly, applications for this program may be submitted at FSA offices by mail or FAX.

The Noninsured Crop Disaster Assistance Program is operated by FSA and CCC under the authority section 196 of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 7333) (the 1996 Act). The 1996 Act requires that eligible program crops be crops that are used for food or fiber or that are specifically identified by the statute. Sea grass and sea oats were neither and therefore were not eligible. Section 10101 of the 2002 Act amended section 196 of the 1996 Act to specifically identify them as eligible crops.

Section 196 of the 1996 Act provides that the Secretary of Agriculture shall operate a noninsured crop disaster assistance program to provide coverage equivalent to the catastrophic risk protection otherwise available under section 508(b) of the Federal Crop Insurance Act (7 U.S.C. 1508(b)). Coverage under section 196 is limited to crops that are commercial or agricultural in nature for which catastrophic risk protection under section 508(b) is not available and that are produced for food or fiber or are specifically included by the statute. Qualifying losses must be due to drought, flood, or other natural disaster, as determined by the Secretary. Among other requirements, the 1996 Act specifies that a producer shall submit an application for noninsured crop disaster assistance at a local office of the Department, that the application must be in such form and contain such information as the Secretary may specify and must be submitted not later than 30 days before the beginning of the coverage period. The coverage period is determined by the Secretary. There are also provisions in the law for acreage reports. Under the statute, differing qualifying loss thresholds are based on whether the crop was planted and failed or whether instead the crop could not be planted because of a qualifying condition. If all other conditions are met, payments will are determined by multiplying the amount by which the harvest is less than 50 percent of the established yield for the crop by 55 percent of the average market price for the crop (or any comparable coverage determined by the Secretary) by a payment rate that takes in other factors. Provisions are also made in the statute for yield determinations. Further details are set out in the final rule published on March 19, 2002, which was a major revision of the NAP regulations.

The rule provides that sea oats and sea grass will be treated as value-loss crops and eligibility will be limited to ornamental plants grown for commercial sale and seeds and transplants produced for commercial sale as propagation stock. The rule provides that claims involving ornamental sea oat and see grass plants will be compensable in the same manner and subject to the same conditions as ornamental nursery stock under section 1437.305 of the existing regulations. For propagation stock (seed or transplant), claims will be compensable under new provisions set out in the rule. The limitations in the rule reflect the limited purpose of the statute and the limitations that apply to other crops under the same program. They include the requirement that an application for coverage be filed at least 30 days in advance of the coverage period. That rule establishes, among other things, the manner in which the beginning of the coverage period, and hence the last date for filing the application for coverage, is determined.

This rule provides that sea oats and sea grass will be treated as “value loss” crops, as opposed to field crops where the loss is not based on the loss of particular plants, but based on loss of an expected yield of a particular plot. As with ornamental crops, all plants that survive the disaster will be treated as not involving a compensable loss even though there may be some damage to the plant. This reflects the orientation of the program to actual yield, rather than quality, losses. In any event, gradations of loss to individual plants would be difficult (a difficulty not contemplated by the statute). It would also be imprecise. Further, in many cases, damaged plants can be rejuvenated.

The Food Safety and Inspection Service (FSIS) administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ) to protect the health and welfare of consumers by preventing the distribution of meat and poultry products that are unwholesome, adulterated, or misbranded. To further the goal of reducing the risk of foodborne illness from meat and poultry products to the maximum extent possible, FSIS issued final regulations on July 25, 1996, mandating Pathogen Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems for federally inspected establishments (61 FR 38806). These regulations require that federally inspected establishments take preventive and corrective measures at each stage of the food production process where food safety hazards occur.

Part 417, the regulations on HACCP systems, requires a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and to identify the preventive measures an establishment can apply to control those hazards in the production of particular products (§ 417.2(a)). Ten potential hazard areas, including microbiological contamination, are listed to guide establishments in this analysis (§ 417.2(a)(3)). Whenever a hazard analysis reveals one or more such hazards are reasonably likely to occur in the production process, the regulations require that the establishment develop and implement a written HACCP plan, for each product, that includes specified control measures for each hazard so identified (§ 417.2(b)(1) and (c)).

Section 417.2(a)(1) provides that a food safety hazard is reasonably likely to occur if a prudent establishment would establish control measures because the hazard historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

The likelihood that a food safety hazard will occur in the production process for a particular product at a given location, and the identification and adequacy of preventive measures to control a likely hazard, must be determined by each establishment. Obviously, conditions that affect such determinations may change over time. For this reason, the HACCP system regulations require that every establishment reassess the adequacy of its HACCP plans at least annually and whenever any changes occur that could affect the underlying hazard analysis or alter the HACCP plans (§ 417.4(a)(3)). New information regarding the fact that E. coli O157:H7 is more prevalent than was previously thought is such a change. When reassessment reveals that a plan no longer meets the requirements for the contents of a HACCP plan, the establishment must modify the plan immediately (§ 417.4(a)(3)).

In 1994, FSIS notified the public that raw ground beef contaminated with E. coli O157:H7 is adulterated under the FMIA unless the ground beef is further processed to destroy this pathogen. Also in 1994, FSIS began sampling and testing ground beef for E. coli O157:H7. (For the Agency's current sampling and testing program instructions, see FSIS Directive 10,010.1, Microbiological Testing Program for Escherichia coli O157:H7 in Raw Ground Beef, February 1, 1998, available on the Internet at http://www.fsis.usda.gov/oppde/rdad/publications.htm and in the Docket Clerk's office.)

On January 19, 1999, FSIS published a policy statement, “Beef Products Contaminated with E. coli O157:H7” (64 FR 2803). This statement explained the Agency's policy governing beef products that contain E. coli O157:H7. The Agency stated that, in evaluating beef products contaminated with E. coli O157:H7, it would distinguish intact cuts of muscle ( e.g. , steaks and roasts) distributed for consumption from non-intact products ( e.g., beef that has been mechanically tenderized by needling or cubing) and from intact cuts of muscle that are to be further processed into non-intact product prior to distribution for consumption ( e.g. , manufacturing trimmings for use in production of ground beef). This statement explained that intact cuts of beef that are to be further processed into non-intact product prior to distribution for consumption must be treated in the same manner as non-intact cuts of beef because pathogens may be introduced below the surface of these products when they are further processed into non-intact products. Manufacturing trimmings ( i.e. , pieces of meat remaining after steaks, roasts, and other intact cuts are removed) are an example of this type of product. Although manufacturing trimmings may be intact, they are generally further processed into non-intact product.

The Agency stated that if non-intact products or intact products that are to be further processed into non-intact product prior to distribution for consumption are found to be contaminated with E. coli O157:H7, they must be processed into ready-to-eat product, or they would be deemed to be adulterated (64 FR 2804). FSIS explained that pathogens, including E. coli O157:H7, may be introduced below the surfaces of non-intact products as the result of the processes by which they are made. As a result, customary cooking of these products may not be adequate to kill the pathogens. In contrast, the meat interior of intact products remains protected from pathogens migrating below the exterior. Consequently, customary cooking of these products will destroy any E. coli O157:H7. Finally, in this Federal Register notice, FSIS requested comments and recommendations relevant to the Agency's policy and to any regulatory requirements that might be appropriate to prevent the distribution of beef products adulterated with this pathogen.

On March 8, 1999, FSIS held a public meeting to discuss the policy addressed in its January 19, 1999, Federal Register notice. On February 11, 2000, FSIS announced that it would hold a public meeting on February 29, 2000, to discuss recent developments concerning E. coli O157:H7 (65 FR 6881). In the February 11, 2000, Federal Register notice, FSIS also responded to comments received concerning the Agency's E. coli O157:H7 policy and again requested comments. On February 29, 2000, FSIS held the public meeting on E. coli O157:H7. At the meeting, numerous organizations presented information on E. coli O157:H7. FSIS presented information on the new testing procedures that it is using for E. coli O157:H7 and on the FSIS risk assessment on E. coli O157:H7. The Agricultural Research Service (ARS) presented information on research concerning the incidence of E. coli O157:H7 in animals entering the slaughter plant and at various stages in the slaughter process. Also, the Centers for Disease Control and Prevention (CDC) presented information concerning its increased estimates for illnesses associated with E. coli O157:H7. A complete transcript of the February 29, 2000, public meeting is available on the Internet at http://www.fsis.usda.gov/oppde/rdad/frpubs/ecolimtg.pdf.

On November 5, 2001, FSIS announced the availability of and requested comments on its draft risk assessment for E. coli O157:H7 in ground beef (66 FR 55912). At this time, FSIS also made the interpretive summary of the risk assessment and draft risk assessment available on the Internet. The draft risk assessment discusses and cites the studies discussed below. As stated below, under “Relevant Data Requiring Reassessment,” the data from some of these studies and FSIS surveillance data provided evidence that E. coli O157:H7 is more prevalent than was thought before these data became available.

Exposure to E. coli O157:H7 has been linked to serious, life-threatening human illnesses (hemorrhagic colitis and hemolytic uremic syndrome). At the February 29, 2000, public meeting, a representative from the CDC presented its national estimates for foodborne illnesses associated with E. coli O157:H7. These estimates showed an increase from previous CDC estimates of illnesses associated with E. coli O157:H7. At that time, CDC increased its estimates for illnesses associated with E. coli O157:H7 because surveillance data allowed a more detailed estimation of mild illnesses not resulting in physician consultation. 1 As FSIS stated in the February 11, 2000, meeting notice, although not all these illnesses were attributable to beef, the increase in illness associated with E. coli O157:H7 indicated that this pathogen occurred more frequently than was previously thought (65 FR 6882). CDC continues to collect data on the incidence of reported cases. Based on recent preliminary FoodNet data, there does not appear to be a sustained decrease in disease associated with E. coli O157:H7. 2

Also at the public meeting, an FSIS representative presented information on the new E. coli O157:H7 testing procedures that the Agency began using on September 3, 1999. This method is approximately four times more sensitive than the previous method. Prior to the introduction of the new FSIS testing method, the prevalence of E. coli O157:H7 in raw ground beef samples tested was 0.149 percent. Using the new method between September 3, 1999, and September 8, 2002, the prevalence of E. coli O157:H7 in raw, ground beef samples tested was 0.797 percent. This increase in E. coli O157:H7 prevalence in raw ground beef samples suggests that the low rate of positive findings in the past may have had more to do with the sensitivity of the method and size of the sample being used than with the rarity of the pathogen.

Also at the February 29, 2000, public meeting, a representative from ARS presented information concerning a recent E. coli O157:H7 prevalence study (hereinafter referred to as the Elder study). 3 In this study of fed cattle, 28 percent (91 of 327) of fecal samples were positive for E. coli O157:H7. Previous studies of fed cattle had found a fecal prevalence of 2 percent (188 of 11,881 samples), 4 4 percent (38 of 1046 samples), 5 6 percent (14 of 240 samples), 6 and, for the study hereinafter referred to as the Smith study, 23 percent (707 of 3054 samples). 7

Three multistate studies reported the apparent prevalence of feedlots containing one or more infected cattle. Even if one animal in a herd was found positive for E. coli O157:H7 the herd was considered positive for E. coli O157:H7. These estimates were 63 percent (63 of 100 feedlots), 8 100 percent (6 of 6 feedlots), 9 and 100 percent (5 of 5 feedlots). 10 Although all the studies cited in the preceding sentence found a high proportion of herds to contain at least one animal that was positive for E. coli O157:H7, except for the Smith study, these studies did not find many animals within a specific herd to be positive for E. coli O157:H7. The Smith and Elder studies found higher within herd E. coli O157:H7 prevalence than all the other studies cited. That is, these studies found more animals within a specific herd to be positive for E. coli O157:H7 than the other studies did.

The study from ARS mentioned above (Elder 2000) also addressed the prevalence of E. coli O157:H7 on carcasses at preevisceration, at postevisceration, and at postprocessing. E. coli O157:H7 was found on 43 percent (148 of 341) of the preevisceration carcasses, 18 percent (59 of 332) of the postevisceration carcasses, and 2 percent (6 of 330) of the postprocessing carcasses.

In addition to fed cattle, culled breeding cattle (dairy and beef cows and bulls) are an important source of beef products. Four studies provided fecal prevalence evidence of E. coli O157:H7 of 1 percent (10 of 1412 samples), 11 1 percent (52 of 4361 samples), 12 2 percent (89 of 4031 samples), 13 and 3 percent (7 of 205 samples). 14

Five multistate studies reported the apparent prevalence of breeding herds containing one or more infected cattle. These estimates were 24 percent (22 of 91 herds), 15 61 percent (8 of 13 herds), 16 75 percent (27 of 36 herds), 17 87 percent (13 of 15 herds), 18 and 100 percent (6 of 6 herds). 19

At the February 29, 2000, public meeting, FSIS presented preliminary results from the FSIS draft risk assessment for E. coli O157:H7 in ground beef. These preliminary results did not incorporate the evidence presented at this meeting from the ARS (Elder 2000). The best estimate of the prevalence of E. coli O157:H7 in live cattle destined for ground beef production was given as just over 10 percent. The bounds of uncertainty depended upon the class of animal considered, fed or culled, and ranged from less than 5 percent to greater than 15 percent. For plants that slaughter culled cattle, the estimated prevalence of E. coli O157:H7-contaminated 2000 pound combo-bins was given as 15 percent, with a range from greater than 5 percent to less than 30 percent. For steers and heifers, the estimated combo bin prevalence was over 40 percent, with a lower bound greater than 20 percent and an upper bound less than 60 percent.

Trim from bins is mixed together and ground to achieve product with specific fat content. The mixing of the contents of several combo bins disperses the E. coli O157:H7 organisms and results in ground product with a lower concentration, but higher prevalence, of contamination than in the original bins. Preliminary risk assessment estimates suggested that nearly 90 percent of grinder loads had at least one E. coli O157:H7 organism present with a lower bound greater than 70 percent and an upper bound greater than 95 percent.

The estimates presented at the public meeting were preliminary and were premised on the assumption that slaughter plants were achieving an average of about 1.5 log10 reduction of E. coli O157:H7 as a result of decontamination measures taken after dehiding and after carcass splitting. At this time, FSIS does not have information about the level of log reduction for E. coli O157:H7 being achieved in specific slaughter operations or thereafter, or about whether the 1.5 log10 reduction modeled in the risk assessment is comparable to what industry is achieving today. If validated interventions being used today result in more than a 1.5 log10 reduction, and other factors remain the same, then the prevalence of E. coli O157:H7 would be a lower percentage than that reflected in the preliminary risk assessment estimates. FSIS requests comment and data on these issues. FSIS is still reviewing the draft risk assessment and may further modify its estimates in the future.

As noted above, on November 5, 2001, FSIS announced the availability of, and requested comments on, its draft risk assessment for E. coli O157:H7 in ground beef (66 FR 55912). At that time, FSIS also submitted the draft risk assessment to the National Academies of Science (NAS) for scientific peer review. FSIS received 6 comments in response to its request for comments in the Federal Register . FSIS is currently reviewing those comments. FSIS expects to receive NAS' comments concerning the risk assessment shortly and may revise the risk assessment based on NAS' comments and the public comments received.

Studies before those of Smith and Elder suggested that E. coli O157:H7 prevalence rates within herds were low. A 1992-1993 FSIS baseline survey of steer and heifer carcasses found 4 (0.2%) of these carcasses E. coli O157:H7-positive, and a 1993-1994 FSIS baseline survey of cow and bull carcasses found none of the carcasses positive for E. coli O157:H7. The USDA's Animal and Plant Health Inspection Service-Veterinary Services-National Animal Health Monitoring System also completed on-farm surveys of dairy cattle in 1992 and feedlot cattle in 1994. These national surveys found E. coli O157:H7 in 0.4 percent of dairy calves sampled and 1.6 percent of feedlot cattle sampled. Thus, these results suggested that E. coli O157:H7 occurred in cattle at a prevalence level that would require substantial numbers of samples to detect the organism in a population.

The results from FSIS' E. coli O157:H7 testing program since FSIS began using its new testing method and certain research studies discussed above provide evidence that E. coli O157:H7 is more prevalent than was thought before these data became available, and that this pathogen may be a hazard that is reasonably likely to occur at all stages of handling raw beef products. The specific studies cited above that suggest that E. coli O157:H7 is more prevalent than previously thought in live cattle and carcasses are the study by Elder et al. and the study by Smith et al. (both cited above).

FSIS is publishing this document to advise federally inspected establishments of the Agency's position on one aspect of its public health strategy to deal with E. coli O157:H7 contamination and to provide an opportunity for comment on that position, as FSIS continues to develop a comprehensive strategy. As explained under the HACCP discussion above, the regulations require that establishments reassess their HACCP plans whenever any changes occur that would affect their hazard analysis or alter their HACCP plans. The availability of FSIS testing data since FSIS began using the new testing method and the information from the Smith and Elder studies presented above is a change that requires establishments to reassess their HACCP plans because these data provided evidence that E. coli O157:H7 is more prevalent than was thought before this data became available.

The Elder and Smith studies were completed in 2000 and 1999, respectively, and published thereafter, and FSIS surveillance data from its new testing method became available in 1999. FSIS has not previously informed manufacturers of beef products that it believes that the availability of these data constitutes a change that could affect an establishment's hazard analysis and alter its HACCP plans for raw beef products. The preliminary results of the draft risk assessment on E. coli O157:H7 support FSIS' position. No more recent data have become available that would affect FSIS' conclusions regarding the prevalence of E. coli O157:H7.

Based on anecdotal information from its inspection program personnel and from In-Depth Verification Reviews (IDVs), FSIS believes that most establishments have not taken the data discussed above into account in their hazard analysis, and that establishments might not have addressed E. coli O157:H7 in their HACCP plans or, for grinding establishments, in programs that serve as prerequisites to HACCP plans. Therefore, the Agency is issuing this notice informing the public of its views concerning the implications of the E. coli O157:H7 data discussed above.

According to the data from the studies discussed above, the fecal prevalence of E. coli O157:H7 in fed cattle is significantly higher than the fecal prevalence of E. coli O157:H7 in culled breeding cattle (dairy, beef cows, and bulls). However, FSIS believes that all establishments producing raw beef products, including those slaughtering culled breeding cattle or using meat from culled breeding cattle in processing, need to reassess their HACCP plans because the data show that E. coli O157:H7 is present in culled breeding cattle, because most slaughter establishments slaughter both fed and culled breeding cattle, and because most beef processing establishments use meat from both fed and culled breeding cattle. FSIS believes that establishments that slaughter both types of cattle or use both types of meat in processing would not develop different HACCP plans for slaughtering fed versus culled breeding cattle or for processing meat from fed versus culled breeding cattle.

Because all establishments are required to reassess their HACCP plans at least annually according to § 417.4(a)(3), all establishments should have reassessed their HACCP plans at least once, and possibly twice, since the February 29, 2000, public meeting. As noted above, at that public meeting, FSIS, ARS, and the CDC presented some of the data that provided evidence that E. coli O157:H7 was more prevalent than previously thought at that time, and that this pathogen may be a hazard that is reasonably likely to occur at all stages of handling raw beef products. In addition, FSIS placed the transcript from the public meeting on its web site shortly after the meeting. Finally, FSIS released the draft risk assessment, which discussed the published data that provide evidence that E. coli O157:H7 is more prevalent than previously thought, on its web page in November 2001.

Because FSIS made some of the data discussed above available in 2000 and released the draft risk assessment in 2001, establishments that produce raw beef products already may have reassessed their HACCP plans based on this data to determine whether E. coli O157:H7 is a hazard reasonably likely to occur in their production of these products, and, if so, whether their HACCP plans appropriately address this hazard. Establishments that already have taken the relevant E. coli O157:H7 data into account in a reassessment are not required to conduct another reassessment of their HACCP plans, provided these establishments have evidence of their reassessment based on this data that is available to FSIS inspection program personnel in their hazard analysis, HACCP plans, or record of reassessment. Establishments should have taken into account all of the data discussed above that suggest that E. coli O157:H7 is more prevalent than previously thought: the FSIS testing data and the data from the Smith and Elder studies.

Establishments that produce raw beef products that have not conducted a reassessment of their HACCP plans based on the relevant E. coli O157:H7 data discussed above to determine whether E. coli O157:H7 is a hazard reasonably likely to occur in their production of these products, and, if so, whether their HACCP plans appropriately address this hazard, are required to conduct a reassessment. If this pathogen is a hazard reasonably likely to occur, then it must be addressed in a HACCP plan through one or more CCPs designed to control the pathogen.

Even establishments that produce intact product will need to reassess their HACCP plans based on the new E. coli O157:H7 data. These establishments are required to reassess their HACCP plans because much intact beef product may be used to make non-intact product, such as ground beef. According to § 417.2(a)(2), establishments are required to identify the intended use or consumers of the finished product. Therefore, to be able to determine the adequacy of their HACCP plans, establishments that produce intact beef products need to determine whether their products will be used to produce raw, non-intact product.

This document addresses only the need for HACCP plan reassessment. FSIS cannot predict the likelihood that an establishment producing raw beef products will need to incorporate, or alter, controls to prevent, eliminate, or reduce E. coli O157:H7 to an acceptable level (i.e., a level that would not be detectable using the FSIS testing method or a method with a sensitivity at least equivalent to FSIS' method) in one or more HACCP plans as a result of plan reassessment. FSIS does believe, however, that given the FSIS testing data and the data from the Elder and Smith studies discussed above, establishments should strongly consider the possibility that E. coli O157:H7 contamination is a hazard reasonably likely to occur in their production of beef products, especially if an establishment produces non-intact product that has been or could be adulterated with E. coli O157:H7 or produces intact product that is to be used for non-intact product, and this non-intact product has been or could be found to be adulterated with E. coli O157:H7.

In determining whether E. coli O157:H7 is a hazard reasonably likely to occur in the production process for their raw beef products, establishments should take into account whether their raw beef products have tested positive for E. coli O157:H7 in either FSIS or industry testing. They should also consider whether there is a reasonable likelihood of E. coli O157:H7 contamination of their raw beef products in the absence of controls (see § 417.2(a)(1)).

Although all establishments producing raw beef products are required to reassess their HACCP plans, some establishments may determine that they do not need to change their HACCP plans. For example, some establishments may already address E. coli O157:H7 in their HACCP plans. Even if these establishments did not take the FSIS testing data and the Smith and Elder data into account in their prior hazard analysis, they may determine that their HACCP plans are still adequate to prevent, eliminate, or reduce E. coli O157:H7 to an undetectable level in light of the data, and that these data do not affect their hazard analysis. Similarly, establishments that produce raw intact product that will not be further processed into raw, non-intact product may determine that these data do not affect their hazard analysis, and that their HACCP plans do not need to be changed.

The regulations require that establishments develop HACCP plans that include critical control points (CCPs): points, steps, or procedures in a food process at which a control can be applied, and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. FSIS considers an acceptable reduction for E. coli O157:H7 to be a reduction to an undetectable level.

Because controls to reduce the risk of E. coli O157:H7 contamination when the product is still intact may be the best means of controlling the hazard, FSIS believes that slaughter establishments and deboning establishments should strongly consider putting in place one or more validated CCPs that are designed to eliminate or reduce E. coli O157:H7 and other pathogens. If such establishments have controls in place to address E. coli O157:H7 specifically, they cannot conclude that the pathogen is not a hazard reasonably likely to occur in the absence of those controls. FSIS believes that any interventions that slaughter and deboning establishments use to address E. coli O157:H7 should be incorporated into their HACCP plans. At this time, FSIS is not aware of any prerequisite programs that are appropriate for use in slaughter and deboning establishments to address E. coli O157:H7. FSIS advises that it intends to scrutinize very closely the hazard analyses and HACCP plans of those slaughter or deboning establishments that conduct, or have conducted, a reassessment and decide that an intervention for E. coli O157:H7 is not necessary.

According to the requirements of § 417.4(a)(1), establishments must validate CCPs to ensure that they can successfully apply a scientifically appropriate CCP to prevent, eliminate, or reduce E. coli O157:H7 under their commercial operating conditions (see 61 FR 38826-38827). Until establishments demonstrate that the CCP achieves the anticipated effect under actual in-plant conditions, effectiveness of the CCP is theoretical, and the plan is not validated. Based on information from inspection program personnel and IDVs, FSIS believes that many establishments have not validated their CCPs based on actual in-plant conditions.

Published scientific studies have demonstrated that there are effective decontamination methods that can be used for preventing, eliminating, or reducing E. coli O157:H7. Establishments can validate their CCPs for E. coli O157:H7 by ensuring that the operation of the CCP in their plant can meet the parameters of these studies, and by challenge studies using an appropriate surrogate for E. coli O157:H7 that could include, but not be limited to, E. coli and coliforms. There are no situations in which inspection program personnel will ask that establishments introduce pathogenic or harmful bacteria into the establishments to validate the effectiveness of CCPs. Establishments can ensure the effectiveness of their CCPs through monitoring, verification, and corrective action procedures in their written HACCP plans.

FSIS believes that establishments that receive product for grinding also should address E. coli O157:H7. These establishments can employ validated CCPs in their HACCP plans to address E. coli O157:H7. Interventions are becoming available to grinders. These establishments can also establish and require that specifications for the raw material that they purchase be met by suppliers. FSIS believes that grinders that have purchase specifications that require that all of their suppliers have one or more CCPs in their HACCP plans that are validated to eliminate or reduce E. coli O157:H7 below detectable levels and that ensure that these specifications are met may determine that no additional steps to address E. coli O157:H7 are necessary in their production process for ground beef. However, given the nature of the pathogen, FSIS strongly recommends that grinders that have purchase specifications addressing E. coli O157:H7 determine whether CCPs preventing E. coli O157:H7 growth or contamination after product receipt are necessary.

Grinders could incorporate purchase specifications to prevent E. coli O157:H7-contaminated product from entering their establishment in their HACCP plans. However, the Agency also recognizes that some may argue that purchase specifications addressing E. coli O157:H7 do not lend themselves to a point, step, or procedure in a food process at which control can be applied (see definition of “critical control point” in § 417.1). Also, if grinding establishments have purchase specifications addressing E. coli O157:H7 that require that incoming product has been treated to eliminate or reduce E. coli O157:H7 to an undetectable level, and if they ensure that these specifications are met, these establishments may determine that they do not need a separate CCP to eliminate or reduce E. coli O157:H7 after receipt of product. In recognition of these arguments, FSIS advises that grinders may choose not to include purchase specifications addressing E. coli O157:H7 as CCPs in their HAACP plans. If they do not include these purchase specifications as CCPs in their HACCP plans, however, establishments should incorporate them in their Sanitation SOPs, which FSIS has recognized as prerequisites for HACCP (61 FR 38834), or in other programs that are prerequisites for HACCP (prerequisite programs).

Current regulations do not include specific requirements for prerequisite programs other than Sanitation SOPs. However, under § 417.5(a)(1), establishments must maintain records of their hazard analysis, including all supporting documentation. According to the regulations, the hazard analysis must include the food safety hazards that can occur before, during, and after entry into the establishment (§ 417.2(a)). If an establishment has determined in its hazard analysis that E. coli O157:H7 is a hazard that can occur at one of these points but is not reasonably likely to occur in the establishment's processing because the establishment has a prerequisite program with purchase specifications addressing E. coli O157:H7, information concerning the prerequisite program is supporting documentation that must be maintained under § 417.5(a)(1). All documentation supporting the hazard analysis must be made available to FSIS upon request (§ 417.5(f)).

FSIS expects the supporting documentation concerning prerequisite programs other than Sanitation SOPs to include the programs' procedures and operational controls in writing. In addition, FSIS expects the documentation to include records that document that the program is effective, and that E. coli O157:H7 is not reasonably likely to occur. Without this documentation, FSIS would question the adequacy of the establishment's HACCP system and hazard analysis.

Establishments should revise their prerequisite programs, as necessary, to ensure their effectiveness and should take appropriate corrective actions when they determine that their prerequisite programs may have failed to prevent contamination or adulteration of product. If establishments that address E. coli O157:H7 in their prerequisite programs and not in their HACCP plans produce E. coli O157:H7-positive product, this occurrence would be considered a “deviation not covered by a specified corrective action” or an “unforeseen hazard” (§ 417.3(b)). Therefore, these establishments would be required to take the corrective actions, including reassessment, set forth in § 417.3(b).

As with other prerequisite programs that include purchase specifications addressing E. coli O157:H7, establishments with Sanitation SOPs that include purchase specifications addressing E. coli O157:H7 may conclude that the pathogen is not reasonably likely to occur in the establishments' processing because of the Sanitation SOPs. However, unlike other prerequisite programs, current regulations provide requirements for Sanitation SOPs and ensure that FSIS has access to establishments' records documenting the implementation and monitoring of the Sanitation SOPs. According to the Sanitation SOP regulations, establishments that include purchase specifications addressing E. coli O157:H7 in their Sanitation SOPs will need to evaluate routinely the effectiveness of these purchase specifications in preventing the adulteration of their products. They will also need to revise these purchase specifications as necessary to keep them effective ( see § 416.14). Moreover, they will need to maintain records to document the implementation, monitoring, and correction of their purchase specifications ( see §§ 416.15 and 416.16).

Under § 416.15, establishments are required to conduct corrective actions when they determine that their Sanitation SOP may have failed to prevent direct contamination or adulteration of product; however, under § 416.15, establishments are not required to reassess their Sanitation SOPs when they determine that their Sanitation SOPs may have failed to prevent direct contamination or adulteration of product. If establishments that address E. coli. O157:H7 in their Sanitation SOPs and not in their HACCP plans produce E. coli. O157:H7-positive product, this occurrence would be considered a “deviation not covered by a specified corrective action” or an “unforeseen hazard” (§ 417.3(b)). Therefore, these establishments would be required to take the corrective actions, including reassessment, set forth in § 417.3(b).

FSIS received a petition dated December 30, 1999, signed by numerous meat and poultry trade organizations (see 65 FR 30952 for information on this petition and the text of this petition). The petition stated that a HACCP plan is only one part of a plant's overall food safety system, and that other integral components of that system include Sanitation SOPs, various good manufacturing practices, and other prerequisite programs that are needed to form the foundation for the HACCP system. The petition stated that FSIS should recognize these other components of establishments' food safety systems when determining whether HACCP plans are adequate.

In this notice, FSIS is recognizing that establishments receiving raw beef product for grinding can effectively include purchase specifications addressing E. coli. O157:H7 in Sanitation SOPs and other prerequisite programs. FSIS has made no general determinations concerning food safety hazards other than E. coli. O157:H7 and no general determinations concerning what circumstances other than grinders' receiving product that meets purchase specifications can be addressed through prerequisite programs, rather than HACCP. If establishments, other than grinders, address any food safety hazard in a prerequisite program, and if grinders include more than purchase specifications addressing E. coli. O157:H7 in their prerequisite programs, FSIS will review the establishments' supporting documentation for these programs and will make a determination concerning the adequacy of these programs, applicable HACCP plans, and hazard analyses on a case-by-case basis.

FSIS does not believe that establishments receiving raw beef product for grinding will be able to substitute Sanitation SOPs or other prerequisite programs addressing E. coli. O157:H7 for their HACCP plans in their entirety because the Agency does not believe that E. coli. O157:H7 contaminated product from outside sources would be the only food safety hazard reasonably likely to occur in the production of ground beef in the absence of controls. For establishments receiving raw beef product for grinding, FSIS believes that Sanitation SOPs or other prerequisite programs together with HACCP plans function as food safety HACCP systems that effectively produce safe, unadulterated product.

All establishments are required to conduct on-going verification activities to ensure that their HACCP plans are effectively implemented (§ 417.4(a)(2)). Whether the establishment has CCPs addressing E. coli. O157:H7 in their HACCP plans or has concluded the pathogen is not reasonably likely to occur because it has purchase specifications that prevent the pathogen from entering the facility, the establishment is required to conduct on-going verification activities to ensure that any CCP is adequately addressing E. coli. O157:H7, or that the purchase specifications continue to prevent the pathogen from entering the facility. FSIS recommends that establishments' verification activities include testing for E. coli. O157:H7.

Establishments in states that have their own inspection programs that produce raw beef products and that have not already done so must reassess their HACCP plans in light of the E. coli. O157:H7 data discussed above. Similarly, producers outside the U.S. that import raw beef product into the U.S. that have not already done so will have to reassess their HACCP systems based on the data discussed above.

Establishments that produce raw beef products are to reassess their HACCP plans unless they have already reassessed their HACCP plans based on the E. coli. O157:H7 data that suggest that the pathogen may be more prevalent than previously thought, and they have evidence of this reassessment that is available to FSIS inspection program personnel in their hazard analysis, HACCP plans, or record of reassessment. Although establishments are not required to maintain a written record of their reassessment, FSIS encourages them to do so.

The Agency intends to instruct its inspection program personnel to determine whether reassessments were conducted or are being conducted and to begin making this determination on November 6, 2002. At this time, inspection program personnel will ensure that all establishments producing raw beef products are aware that the Agency has issued this notice and will ensure that those establishments that have not yet reassessed their HACCP plans based on the relevant E. coli O157:H7 data discussed above begin their reassessment in time to complete it by the following date according to plant size: December 6, 2002 for large plants (all establishments with 500 or more employees); February 4, 2003 for small plants (all establishments with 10 or more employees but fewer than 500); and April 7, 2003 for very small plants (all establishments with fewer than 10 employees or annual sales of less than $2.5 million). FSIS will not begin enforcing the required reassessment until December 6, 2002 for large plants; February 4, 2003 for small plants; and April 7, 2003 for very small plants. By looking into establishments' reassessment actions prior to the time they are required to complete their reassessments, FSIS will ensure that all establishments producing raw beef products, including those that are small and very small businesses that may not belong to a trade association, are aware of this notice. FSIS will mail this notice to all small and very small plants prior to the effective date for reassessment.

The Agency then intends to instruct its inspection program personnel to collect data concerning the outcomes of the required reassessment and to begin collecting this data on: December 23, 2002 for large plants; February 19, 2003 for small plants; and April 21, 2003 for very small plants. Inspection program personnel will collect data concerning (1) whether establishments reassessed their HACCP plans based on the relevant E. coli O157:H7 data prior to or after publication of this notice; (2) whether establishments changed their HACCP plans or prerequisite programs as a result of a reassessment that took this data into account; (3) if establishments changed their HACCP plans or prerequisite programs, how the plans or prerequisite programs were changed; and (4) if establishments did not change their HACCP plans or prerequisite programs, the reasons the plans or programs were not changed. If an establishment does not reassess its HACCP plans in accord with this document, FSIS will evaluate the establishment's compliance with Part 417.

FSIS is making available guidelines entitled, “Guidance for Beef Grinders and Suppliers of Boneless Beef and Trim Products” on the Internet ( http://www.fsis.usda.gov/oppde/rdad/publications.htm ). In this guidance material available today, FSIS is providing recommendations for reducing the occurrence of E. coli O157:H7 and Salmonella in ground beef, boneless beef, and trim products. FSIS initially made this guidance material available to the public in March 1998. FSIS has expanded this guidance material to include guidance for suppliers of boneless beef and trim and recommendations for reducing Salmonella in ground beef, boneless beef, and trim products.

In the guidance material, to further reduce the risk of E. coli O157:H7 contamination after product receipt, FSIS is recommending that grinders receiving product from more than one supplier prevent any mixing of product from different suppliers, unless they can demonstrate that the source materials from the different suppliers have been adequately treated to eliminate or reduce E. coli O157:H7 to an undetectable level. Keeping product from different suppliers separate will prevent any potentially E. coli O157:H7-contaminated source material from adulterating source materials from other suppliers. Also, by keeping product from different suppliers separate, grinders will be able to identify the potential source of any E. coli O157:H7-contaminated product should the pathogen be detected. If FSIS finds samples of ground beef produced from suppliers' source materials outside the grinding establishment or retail facility to be positive for E. coli O157:H7, FSIS intends to notify the supplying establishments that they may have supplied E. coli O157:H7-positive product to a grinding establishment or retail facility.

FSIS intends to gather pertinent information concerning suppliers from Federal grinding establishments and retail facilities. If FSIS confirms that ground product is positive for E. coli O157:H7, FSIS intends to obtain from Federal grinding establishments the following information concerning their suppliers of the source materials: the name, point of contact, and phone number for the establishments supplying the source materials for the lot of ground beef sampled; the supplier lot numbers and production dates; and any other information that would be useful to suppliers that may have supplied E. coli O157:H7-positive product to Federal grinding establishments. Similarly, at the time FSIS collects samples of ground beef from retail facilities, FSIS will obtain from the retail facility the names and establishment numbers of the establishments supplying the source materials for the lot of ground beef sampled, the supplier lot numbers and production dates, and any other information that would be useful to suppliers if they are later notified of an E. coli O157:H7 positive finding.

Under § 320.1(b)(1), establishments and retail facilities are required to keep records of each transaction involving their purchasing or receiving any meat or meat food product. These records must show the name or description of the articles they purchase or receive (§ 320.1(b)(1)(i)) and the name and address of the seller of the articles they purchase (§ 320.1(b)(1)(iv)). Establishments and retail facilities must provide FSIS access to these records (§ 320.4, 21 U.S.C. 642). FSIS expects that supplier lot numbers and production dates are normally available at Federal grinding establishments and retail facilities. In addition, FSIS expects that establishments or retail facilities would normally obtain the contact information FSIS is collecting.

In addition, FSIS is making available on the Internet address previously listed new guidance material on reducing the occurrence of E. coli O157:H7 for beef slaughter establishments and for live animal producers. In the guidance material for beef slaughter establishments, FSIS has included examples of published studies of decontamination methods that can be used as critical control points addressing E. coli O157:H7.

The Agency invites comments on the guidance materials it is making available. In the guidance materials, FSIS is emphasizing that it is important for everyone who is involved in producing beef products to have in place measures designed to prevent, eliminate, or reduce the presence of E. coli O157:H7 in their products.

In both the guidance material for beef grinders and suppliers of boneless beef and trim products and the guidance material for beef slaughter establishments, FSIS is recommending that establishments consider that E. coli O157:H7 prevalence may be higher in April through September than during other times of the year, and that they may have to account for this increased prevalence in their HACCP systems. Several studies show that the period from June to September is a high prevalence season. 20 In addition, FSIS has recently reviewed establishment testing data that show greater E. coli O157:H7 prevalence in April through September. To account for increased E. coli O157:H7 prevalence, establishments may need to conduct more frequent or more rigorous verification activities, and they may need to employ more rigorous interventions, during April through September.

Finally, at the Internet address previously listed, FSIS is making available guidance material on the procedures for joint FSIS and FDA approval of ingredients and sources of radiation, including antimicrobials, used in the production of meat and poultry products and specific guidance on the use and labeling of ingredients and sources of radiation used to reduce microorganisms, particularly E. coli O157:H7, on beef carcasses, ground beef, and beef trimmings. This guidance document also includes a discussion on direct and secondary direct food additives and the appropriate use of the ingredient statement on the label of treated meat.

Currently, FSIS tests only raw ground beef products for E. coli O157:H7. In addition to continuing to test for E. coli O157:H7 in raw ground beef, FSIS is considering testing raw beef trimmings and other intact materials used in non-intact product and beef carcasses and parts (primals and subprimals) that will be processed into non-intact product. FSIS is considering testing trimmings, other source materials for non-intact product, and carcasses and parts that will be processed into non-intact product because controls to reduce the risk of E. coli O157:H7 when the product is still intact may be among the best ways to control the hazard. FSIS testing would verify the effectiveness of these controls. Such controls would include interventions used at slaughter, proper chilling practices, and segregating product that has been treated with interventions from product that has not. The only treatment available to eliminate E. coli O157:H7 in raw, non-intact product ( e.g. , ground beef, blade tenderized steaks, and blade tenderized roasts) is a full bactericidal treatment, such as irradiation or cooking. However, there are also treatments that can be used that have been shown to reduce significantly the level of this pathogen. At this time, FSIS has not finalized plans to begin E. coli O157:H7 testing of raw beef trimmings, other intact materials used in non-intact product, and beef carcasses and parts that will be processed into non-intact product.

Although it has not finalized its plans regarding verification activities at establishments that produce intact product, FSIS intends to conduct verification activities at establishments that supply intact product to grinding establishments when the Agency determines that a supplier may be responsible for E. coli O157:H7-positive ground product. In this situation, FSIS intends to conduct verification activities concerning the supplier's HACCP system and Sanitation SOPs. FSIS also intends to conduct verification tests on trim when the Agency finds ground product at a grinder that receives product from outside sources positive for E. coli O157:H7 and is able to identify the supplier.

FSIS received a petition from the Center for Science in the Public Interest (CSPI), dated July 1, 2002, requesting that, in addition to its current testing of raw, ground beef for E. coli O157:H7, FSIS conduct E. coli O157:H7 testing of raw beef carcasses and beef trim. In their petition, CSPI also stated that slaughterhouses should be required to conduct E. coli O157:H7 testing of carcasses and trimmings. FSIS has posted a copy of the petition on the Internet at the address previously listed.

FSIS also received a letter from Excel Corporation, dated June 10, 2002, that included recommendations for changing FSIS” testing program. Excel Corporation stated that FSIS” sampling frequency should be based on what scientific evidence shows about the applied intervention's effectiveness in reducing E. coli O157:H7. Excel also stated that carcasses would need to be sampled more frequently than trim and trim more frequently than ground beef to reach the same level of statistical verification of the effectiveness of an intervention process.

Excel also recommended that FSIS provide that ground beef that has been tested and found negative for E. coli O157:H7 could be labeled to indicate this fact, so that FSIS program personnel would reduce their sampling of this product once it is at retail. Excel recommended the following statement be allowed on product that tests negative for E. coli O157:H7: “Product sampled and sample tested and found negative for E. coli O157:H7.” FSIS has posted a copy of the letter on the Internet.

In modifying its verification sampling and testing program for E. coli O157:H7, FSIS will consider the data that its inspection program personnel collect concerning establishments” actions in response to the required HACCP plan reassessment and comments received concerning the Agency's E. coli O157:H7 testing program, the CSPI petition, and the letter from Excel Corporation.

According to the Agency's current sampling and testing program instructions in FSIS Directive 10,010.1, FSIS does not typically collect raw ground beef samples for E. coli O157:H7 testing at establishments that conduct activities addressing E. coli O157:H7 that are specified in the Directive, including testing for E. coli O157:H7. Recently, FSIS found that some of these establishments producing raw ground beef have had problems with E. coli O157:H7 contamination. Therefore, FSIS is in the process of revising the Directive so that no establishments producing raw ground beef will be exempt from FSIS E. coli O157:H7 sampling and testing. FSIS intends to sample and test product from all grinding establishments at this time. FSIS will also be developing a risk-based verification program that takes into account such factors as volume of production and effectiveness of interventions.

FSIS also intends to revise Directive 10,010.1 to make it consistent with HACCP. According to the existing Directive, if FSIS collects a raw ground beef sample from an establishment that tests positive for E. coli O157:H7, FSIS must continue to collect samples from that establishment until the Agency has obtained 15 consecutive negative test results.

FSIS intends to remove this provision from the Directive because FSIS believes that this policy is inconsistent with HACCP. Under HACCP, it is the establishment's responsibility to take appropriate corrective actions when a sample tests positive for E. coli O157:H7.

When FSIS has removed from the Directive the provision requiring 15 consecutive negative FSIS E. coli O157:H7 test results following an FSIS E. coli O157:H7 positive test result, FSIS will exercise its discretion in determining the appropriate number of follow-up samples to collect and test and will make this determination based on the suspected cause of E. coli O157:H7 contamination and the establishment's corrective action.

The current Directive defines the “sampled lot” as all raw ground beef products produced between performance of complete cleaning and sanitization procedures for all equipment used in handling or processing a raw ground beef product. FSIS believes that this definition is too prescriptive, and that, under HACCP, establishments should be given more flexibility concerning the definition of the sampled lot. Therefore, FSIS is revising the Directive to recognize the establishment's definition of the sampled lot, provided the establishment has a scientific or other supportable basis for defining the sampled lot.

FSIS cautions, however, that an establishment's defined lot size does not relieve an establishment from its responsibility to consider whether there are connections between lots. For example, if multiple lots of raw ground product were produced from source materials from the same production lot of a single supplier, and some of this product was found positive for E. coli O157:H7, FSIS would expect the establishment to have a scientific basis that justifies why any raw ground product produced from those source materials should not be considered to be adulterated.

Finally, FSIS intends to revise the Directive to specify that the Agency will only collect samples of product that has passed pre-shipment record review in accordance with § 417.5(c).

FSIS does not intend to discontinue its E. coli O157:H7 testing program. By conducting its own verification sampling and testing program, FSIS will have meaningful data on the occurrence of E. coli O157:H7 in beef processing operations. FSIS invites comment on the issues related to FSIS Directive 10.010.1.

In response to the February 11, 2000, notice announcing the February 29, 2000, public meeting, FSIS received 294 comments, 285 of which were identical comments. Comments were from consumers, consumer groups, industry associations, a food animal concerns organization, and an FSIS employee. Comments addressed various issues including FSIS” policy concerning non-intact products announced in the January 19, 1999, policy statement, FSIS and industry testing for E. coli O157:H7, and the FSIS E. coli O157:H7 risk assessment data that were presented at the February 29, 2000, public meeting. In addition, several commenters responded specifically to the questions for consideration that FSIS listed in the February 11, 2000, notice.

FSIS considered these comments when it developed plans to make the intended changes to Directive 10,010.1 discussed above. FSIS will continue to consider these comments, any comments submitted in response to this notice, the data that its inspection program personnel collect concerning establishments' actions resulting from the required reassessment, and baseline data for raw beef components of ground beef and beef patties and, possibly, baseline data for carcasses, as it determines how it will modify its E. coli O157:H7 testing program and as it makes any additional changes to the Directive addressing the program.

In May 2001, FSIS requested that the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) answer several questions with regard to E. coli O157:H7 in blade-tenderized, non-intact beef. NACMCF reviewed data from Kansas State University to respond to these questions. A February 14, 2002, report from NACMCF that includes FSIS' questions and NACMCF's response to the questions is available on the Internet at: http://www.fsis.usda.gov/OPHS/NACMCF/index.htm.

Based on the Kansas State data, NACMCF concluded that non-intact, blade tenderized beef steaks could potentially contain an infective dose of E. coli O157:H7 in their interior. NACMCF also concluded that blade tenderized steaks do not present a greater risk to consumers than intact beef steaks with regard to E. coli O157:H7 if the meat is oven broiled and cooked to an internal temperature of 140°F or above. However, NACMCF did not conclude that blade tenderized steaks pose no greater risk than intact steaks when cooked by other methods or when cooked to lower temperatures. The report suggested that blade-tenderized steaks may pose a risk, particularly to immunocompromised individuals, when served very rare with cold spots (that is, when cooked to an internal temperature of less than 120°F). All of NACMCF's risk estimates were based on a worst case scenario that assumed a very high concentration (3 x 10 3 cfu/gm) of E. coli O157:H7 in raw product.

NACMCF concluded that there is insufficient data to assess whether non-intact, blade tenderized beef roasts present a greater risk to consumers than intact beef roasts with regard to E. coli O157:H7 if prepared similarly to intact beef roasts.

Similarly, NACMCF concluded that there was insufficient data to respond to the question of whether scientific evidence supports the need for a labeling requirement to distinguish between intact and non-intact products to protect the public.

The NACMCF report identifies research needs for addressing E. coli O157:H7 in blade tenderized steaks and makes recommendations to FSIS concerning the Agency's future requests to NACMCF about this issue. In the event of an outbreak or a sporadic case of illness attributed to the consumption of beef steak, the report recommends that the CDC and FSIS gather data on cooking practices for the product that caused the illness, the processing of this product, and the purchase locations of this product.

FSIS has also conducted a comparative risk assessment of intact (nontenderized) and non-intact (blade tenderized) steaks. The results of the risk assessment are consistent with those of NACMCF. The risk assessment concluded that the risk of E. coli O157:H7 illness is not greater for broiled tenderized steaks than for broiled non-tenderized steaks at temperatures between 110°F and less than 140°F, regardless of the initial E. coli O157:H7 contamination level or the susceptibility of the consumer. Also, the risk assessment concluded that the risk of illness associated with E. coli O157:H7 from broiled tenderized and broiled non-tenderized steaks cooked to 140°F is miniscule, regardless of the initial contamination level or susceptibility of the consumer. Finally, the FSIS risk assessment concluded that the risk of illness is slightly higher for grilled or fried tenderized steaks compared to grilled or fried non-tenderized steaks at temperatures between 110°F and 140°F. The FSIS comparative risk assessment of intact and non-intact (blade tenderized) steaks is still a draft document and is available on the Internet address at: http://www.fsis.usda.gov/oppde/rdad/publications.htm. FSIS invites comments on this risk assessment.

FSIS also received a letter dated August 27, 2002, from the National Cattlemen's Beef Association concerning a study that evaluated the surfaces of beef sub-primal cuts for the presence of E. coli O157:H7 prior to mechanical tenderization. According to this letter, the results of this study show that the incidence of E. coli O157:H7 on sub-primals is very low. FSIS is interested in evaluating the data from this study. The Agency may incorporate these data into its comparative risk assessment of intact and non-intact steaks. Therefore, these data may influence the comparative risk assessment.

FSIS is reviewing the NACMCF report and its draft risk assessment for E. coli O157:H7 in intact and non-intact (blade tenderized) steaks and will consider NACMCF's conclusions and the conclusions from the risk assessment with regard to the policy announced for non-intact products in the January 19, 1999, Federal Register (discussed above, under “ E. coli O157:H7 policy”). At this time, FSIS believes that the public health hazard presented by E. coli O157:H7 and the prevalence of E. coli O157:H7 in these products continues to support application of the policy announced in the January 19, 1999, Federal Register . There is a lack of data on industry and consumer practices for cooking pinned, needled, and blade tenderized steaks ( e.g. , grilling, oven broiling, or frying) and a lack of data on the proportion of industry outlets and consumers that prepare these products according to each of these different methods. If FSIS obtains substantial and reliable data showing that industry and consumers customarily cook pinned, needled, and blade tenderized products in a manner that destroys E. coli O157:H7, FSIS would consider modifications to its policy concerning E. coli O157:H7 in these products.

Public awareness of 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 notice, FSIS will announce it and make copies of this Federal Register publication available through 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.

Public Law 100-656, enacted on November 15, 1988, incorporated into the Small Business Act the previously existing regulation that recipients of Federal contracts set aside for small businesses or SBA 8(a) Program procurement must provide the product of a small business manufacturer or processor, if the recipient is other than the actual manufacturer or processor. This requirement is commonly referred to as the Nonmanufacturer Rule. The SBA regulations imposing this requirement are found at 13 CFR 121.906(b) and 121.1106(b). Section 303(h) of the law provides for waiver of this requirement by SBA for any “class of products” for which there are no small business manufacturers or processors in the Federal market. To be considered available to participate in the Federal market on these classes of products, a small business manufacturer must have submitted a proposal for a contract solicitation or received a contract from the Federal government within the last 24 months. The SBA defines “class of products” based on two coding systems. The first is the Office of Management and Budget North American Industry Classification System. The second is the Product and Service Code established by the Federal Procurement Data System.

The Program is a pilot authorized by statute at a level of $15 million for each of five (5) fiscal years from 2000 through 2004. The Program enables SBA to make low interest, fixed rate loans to small businesses for the purpose of implementing mitigation measures that will protect them from disaster related damage. The Program was developed in support of FEMA's Pre-Disaster Mitigation Program, which covers businesses located in eligible communities as determined by FEMA. This program encourages prevention rather than relying solely on a response and recovery approach to emergency management. The purpose of the Program is to implement techniques and technologies that will mitigate the effects of natural disasters. Implementation will enable SBA to lend to small businesses in disaster prone areas to help them avert and lessen the costs of future disaster inflicted damages. This is the first time, since SBA has administered the disaster loan program beginning in 1953, that SBA is empowered to administer a pre-disaster mitigation loan program.

SBA's current Program rules were effective October 1, 1999. 64 FR 48275 (September 3, 1999). However, SBA has not made any loans under these rules for several reasons. First, SBA is required by statute to “use mitigation techniques in support of a formal mitigation program established by the [FEMA] * * *” 15 U.S.C. 636(b)(1)(C). In 1999, FEMA had not yet completely established its pre-disaster mitigation program, then known as “Project Impact.” Communities had to apply to FEMA to be accepted as a pre-disaster mitigation eligible community. This took time. Next, FEMA's pre-disaster mitigation program was placed on hold, pending appropriations in the FY02 Departments of Veterans Affairs, Housing and Urban Development and Independent Agencies Appropriations Act. On November 26, 2001, the appropriations act provided $25 million to FEMA for its pre-disaster mitigation grant program. FEMA is now re-evaluating, revisiting and revamping its pre-disaster program. Therefore, SBA decided to proceed with this final rule to provide clear guidance and complete instructions to the public to support the FEMA program.

On June 14, 2000, SBA published a proposed rule on the Program in the Federal Register requesting public comment (65 FR 37307). This final rule clarifies the application and loan approval processes and makes editorial changes to make the regulation more understandable. The final rule explains the Program, defines “mitigation measure,” provides the purpose of pre-disaster mitigation loans, and explains how to apply for the loans, the maximum amount and interest rate of the loans, how SBA makes Program funding decisions, and what happens if Program funds run out or an application is denied. The final rule also contains a new application package for the Program approved by the Office of Management and Budget.

SBA received only one comment, from FEMA, which suggests several minor changes.

First, FEMA suggests that SBA refer to the Program as a “community based initiative” instead of referencing it as Project Impact. We agree with FEMA's recommendation and have deleted any reference to Project Impact in the final rule.

Second, FEMA recommends that SBA clarify that an applicant for a pre-disaster mitigation loan needs to submit a “written statement” from a local or State coordinator and that the written statement must include the information contained in the regulation. We agree with FEMA's recommendation and use the phrase “written statement” consistently in this final rule along with an appropriate cross-reference to the requirements in § 123.408.

Third, FEMA requests that SBA add a clarifying sentence which states that “the State or local coordinator's written statement does not constitute an endorsement or technical approval of the project and is not a guarantee that the project will prevent damage in future disasters.” SBA agrees with this comment and adds the requested language to § 123.408.

SBA has not adopted one of FEMA's comments. FEMA requested that SBA delete the references to participating pre-disaster mitigation community locations in § 123.403(a) because these communities may grow and change over time. SBA decided to retain the references to participating pre-disaster mitigation communities in § 123.403(a) because these are general references and we encourage the public to contact FEMA for more detailed information. SBA anticipates that at a minimum, the general information will serve to inform applicants in unique communities ( e.g. , the District of Columbia and Puerto Rico) that they may be eligible to participate in the Program.

In addition to the changes made in response to FEMA's comments, SBA makes a few changes in this final rule for the purpose of clarification.

In § 123.21 (“What is a mitigation measure?”) SBA clarifies that mitigation measures can occur before a disaster (pre-disaster) or after a disaster (post-disaster). In addition, we include appropriate cross-references for further information on either pre-or post-disaster mitigation efforts for homes or businesses.

SBA also revised the final rule in an effort to accurately define borrowing limits for each mitigation category: pre-disaster mitigation loans for businesses; post-disaster mitigation loans for businesses; and post-disaster mitigation loans for homes. SBA did not alter the substance of text dealing with the borrowing limits, but simply changed the location of the information within the rule so that each borrowing limit is addressed under the appropriate mitigation category. To accomplish this, we deleted the proposed § 123.22 (“How much can your business borrow for mitigation?”) and we have relocated this information to § 123.204 (“How much can your business borrow for post-disaster mitigation?”) and § 123.405 (“How much can your business borrow with a pre-disaster mitigation loan?”). When relocating this information, SBA deleted the inappropriate text references to primary residences or personal property. These references should not have been included in the borrowing limit section for business mitigation loans. These references to primary residences or personal property should have been included in the section addressing the borrowing limit for mitigation loans for homes. As such, we have added a new § 123.107 (“How much can I borrow for post-disaster mitigation for my home?”).

Another change is included in §§ 123.400 (“What is the Pre-Disaster Mitigation Loan Program?”) and 123.401(a) (“What types of mitigation measures can your business include in its application for a pre-disaster mitigation loan?”). In these sections we inadvertently left out the word “contents” from the text. The Pre-Disaster Mitigation Loan Program is designed, in part, to support mitigation measures geared towards protecting commercial real property, leasehold improvements, and the contents of either. As such, SBA adds the word “contents” to the relevant §§ 123.400 and 123.401(a).

Proposed § 123.410 (“When will SBA make funding decisions?”) would have required SBA to wait to make funding decisions until 60 days after the opening of a 30-day application window. This would have allowed SBA to receive and process all applications before deciding which applications to fund. SBA has concluded, however, that there is no reason to delay funding decisions since each application is evaluated on its own merits and not in comparison to the other applications received during that application window. Accordingly, SBA has deleted proposed § 123.410. SBA has redesignated proposed §§ 123.411—123.413 as §§ 123.410—123.412, respectively.

SBA also has concluded that it should date stamp each application when it is received, rather than after it is screened for completeness. Since SBA will be using multiple screeners to review the applications, an applicant's ranking should not be dependent upon the efficiency or schedule of a particular screener. Date stamping upon receipt will eliminate this possibility. In addition, SBA has decided against time-stamping applications. Instead, applications that are received on the same date will be assigned a ranking through the use of a computerized random number generator. SBA believes this is a more equitable way to assign priorities to applications received essentially at the same time. New § 123.410 is revised to reflect these changes.

This rule is a “significant” regulatory action within the meaning of Executive Order 12866 and was reviewed by the Office of Management and Budget. As a new pilot program authorized at $15 million for 5 years, OMB determined that the Program raised potential budgetary, legal and policy issues and required coordination with another Federal agency (FEMA). In 1999 Congressional Budget Office (CBO) estimated that the SBA would require an annual appropriation of $3 million to cover the subsidy costs of the proposed program at a 22 percent subsidy rate. Outlays would be about $2 million in 2000 and $3 million in each year during the 2001-2004 period, assuming appropriations of the necessary amounts. CBO estimates that administrative costs, both for managing the Program and preparing a report to Congress required by the bill, would be well below $500,000 in any year.

When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (RFA) requires the agency to prepare a final regulatory flexibility analysis describing the need for and objectives of the rule; a summary of the issues raised by the public comments in response to the initial regulatory flexibility analysis; and a description of the significant alternatives to the rule consistent with the stated objectives of applicable statutes and designed to minimize any significant economic impact of the rule on small entities. 5 U.S.C. 604(a). Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

In the proposed rule, SBA certified that the proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612. The basis of the certification was that since Congress has limited the funding level for this pilot program, the program can only serve a limited number of small businesses. With a maximum loan amount of $50,000, the number of small businesses affected under the program would be 300. Even if the loan amounts did not reach the maximum level, and amounted to only $25,000 per loan, the number of small businesses affected would only be 600. SBA did not consider the number to be substantial, in view of the fact that there could be as many as some 13-16 million small businesses across the country. No comments were received on the certification.

SBA has also determined that the final rule will not have a significant economic impact on a substantial number of small businesses. While the amount of the loan may have a significant impact on the businesses that receive them, the loans will not be going to a substantial number of small businesses. As stated in the proposal, at the maximum level, the loans will only affect 600 small businesses. Also as stated in the proposal, there are 13 to 16 million small businesses across the country, and 600 is not a substantial number. Accordingly, the Administrator of the SBA hereby certifies to the Chief Counsel of Advocacy of the SBA that this rule will not have a significant economic impact on a substantial number of small businesses.

For the purposes of the Paperwork Reduction Act, 44 U.S.C. chapter 35, SBA has submitted the Pre-Disaster Mitigation Small Business Loan Application (application) to the Office of Management and Budget (OMB) for review and OMB has given its clearance. SBA did not receive any comments from the public regarding this proposed collection of information and only non-substantive, clarifying changes have been made to the proposed application package. The application will allow small businesses to apply for pre-disaster mitigation loans and will provide SBA with the information necessary to evaluate applicants. The application requests such information as name, address, location and type of mitigation project, type of business, management information, organization type, and financial information to permit SBA to determine repayment ability. The applicant will have to complete an application each time it applies for a pre-disaster mitigation loan. SBA estimates that the time necessary to complete an application for the Program will average 2 hours.

For purposes of Executive Order 13132, SBA has determined that this final rule has no federalism implications.

For purposes of Executive Order 12988, SBA has determined that this final rule is drafted, to the extent practicable, to be in accordance with the standards set forth in section 3 of that Order.

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay certification, and thus delivery, of the affected airplane. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance; however, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4:00 p.m., Monday through Friday, except Federal holidays.

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

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

On June 17, 2002, Aircraft Systems & Manufacturing, Inc., Georgetown, TX, applied for a supplemental type certificate (STC) to modify Boeing 737-100/-200/-300 series airplanes. These airplanes are low-wing, pressurized transport category airplanes with two wing-mounted jet engines. They are capable of seating between 100 and 150 passengers, depending upon the model and configuration. The modification incorporates the installation of a dual Air Data Control System consisting of a single air data computer and electronic altimeter for display of No. 1 altitude data, an air data display unit (ADDU) for display of No. 2 altitude data and an altitude alerter. These systems have a potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, Amendment 21-69, effective September 16, 1991, Aircraft Systems & Manufacturing, Inc. must show that the Boeing 737-100, -200, and -300 series airplanes, as modified to include the new IS&S Digital Air Data Control System, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A16WE or the applicable regulations in effect on the date of application for the change. Subsequent changes have been made to 21.101 as part of Amendment 21-77, but those changes do not become effective until June 10, 2003. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The specific regulations included in the certification basis for the Boeing 737-100, -200, and -300 series airplanes include 14 CFR part 25, as amended by amendments 25-1 through 25-3, 25-7, 25-8, and 25-15.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , part 25, as amended) do not contain adequate or appropriate safety standards for the Boeing 737 -100, -200, and -300 Series airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Boeing 737 -100, -200, and -300 series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

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

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

As noted earlier, the Boeing 737-100, -200, and -300 series airplanes modified by Aircraft Systems & Manufacturing, Inc. will incorporate a new IS&S Digital Air Data Control System that will perform critical functions. These systems may be vulnerable to high-intensity radiated fields external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards that address the protection of this equipment from the adverse effects of HIRF. Accordingly, these systems are considered to be novel or unusual design features.

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

To ensure that a level of safety is achieved that is equivalent to that intended by the regulations incorporated by reference, special conditions are needed for the Boeing 737-100, -200, and -300 series airplanes modified by Aircraft Systems & Manufacturing, Inc. These special conditions will require that the new IS&S Digital Air Data Control System, which performs critical functions, be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

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

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

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

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

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

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

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

As discussed above, these special conditions are applicable to Boeing Model 737-100, -200, and -300 series airplanes modified by Aircraft Systems & Manufacturing, Inc. to install new IS&S Digital Air Data Control System. Should Aircraft Systems & Manufacturing, Inc. apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate A16WE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well under the provisions of 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

This action affects only certain design features on the Boeing Model 737-100, -200, and -300 series airplanes modified by Aircraft Systems & Manufacturing, Inc. to include the new IS&S Digital Air Data Control System. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplanes.

The substance of the special conditions for these airplanes has been subjected to the notice and comment procedure in several prior instances and has been derived without substantive change from those previously issued. Because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 97-14-04, amendment 39-10061 (62 FR 35068, June 30, 1997), which is applicable to certain Boeing Model 737-100, -200, -300, -400, and -500 series airplanes; and AD 2000-22-02 R1, amendment 39-11948 (65 FR 69239, November 16, 2000), which is applicable to all Boeing Model 737 series airplanes; was published in the Federal Register on November 13, 2001 (66 FR 56783). The action proposed to require installation of a new rudder control system and changes to the adjacent systems to accommodate that new rudder control system.

The National Transportation Safety Board (NTSB) has identified the most probable cause of two major accidents on Model 737 series airplanes as a jammed secondary slide in the main rudder power control unit (PCU) servo valve in combination with overtravel of the primary slide. While AD 97-14-04 addresses what was considered to be this most likely cause of uncommanded rudder hardovers, the FAA recognizes that other causes are still possible.

Subsequently, we determined that the existing system design architecture is unsafe due to inherent failure modes, including single-jam modes and certain latent failures or jams, which, when combined with a second failure or jam, could cause an uncommanded rudder hardover event and consequent loss of control of the airplane. These failure modes remain even following accomplishment of the actions required by AD 97-14-04, amendment 39-10061 (62 FR 35068, June 30, 1997).

In addition, we received information from the Independent 737 Flight Controls Engineering Test and Evaluation Board (ETEB) verifying the existence of the failure modes described above in the rudder system of all Model 737 series airplanes that can cause an uncommanded rudder hardover.

Because of the existing design architecture, we issued AD 2000-22-02 R1 to include a special non-normal operational “Uncommanded Rudder” procedure, which provides necessary instructions to the flightcrew for control of the airplane during an uncommanded rudder hardover event. The revised rudder procedure included in AD 2000-22-02 R1 is implemented to provide the flightcrew with a means to recover control of the airplane following certain failures of the rudder control system. However, such a procedure, which is unique to Model 737 series airplanes, adds to the workload of the flightcrew at a critical time when the flightcrew is attempting to recover from an uncommanded rudder movement or other system malfunction. While that procedure effectively addresses certain rudder system failures, we find that such a procedure will not be effective in preventing an accident if the rudder control failure occurs during takeoff or landing.

For these reasons, we have determined that the need for a unique operational procedure and the inherent failure modes in the existing rudder control system, when considered together, present an unsafe condition. In light of this, we proposed to eliminate the unsafe condition by mandating incorporation of a newly designed rudder control system. The manufacturer is currently redesigning the rudder system to eliminate these rudder failure modes. The redesigned rudder control system will incorporate design features that will increase system redundancy, and will add an active fault monitoring system to detect and annunciate to the flightcrew single jams in the rudder control system. If a single failure or jam occurs in the linkage aft of the torque tube, the new rudder design will allow the flightcrew to control the airplane, using normal piloting skills, without operational procedures that are unique to this airplane model.

Since the issuance of the notice of proposed rulemaking (NPRM), which proposed to require the supersedure of AD 97-14-04 and AD 2000-22-02 R1, we have determined that this final rule needs to supersede five additional ADs, which are listed in the table below. Our decision to supersede these ADs was based on a number of factors. First, the new rudder control system required by this AD will better address the identified unsafe condition through redundancy in the system architecture, which will increase reliability. Second, the requirements of those ADs will no longer be relevant to or necessary for the new rudder control system, since the parts required by those ADs will not be included in the design for the new rudder control system. The five additional ADs are listed in the table below and described in the following paragraphs:

• AD 95-06-53, applicable to all Boeing Model 737 series airplanes, requires identification of the part and serial numbers of the main rudder PCU; and replacement of certain PCUs with serviceable parts, if necessary. That AD corrects an unsafe condition caused by improper tooling used to torque the spring retaining nut in the servo valve of the main rudder PCU. However, the PCUs identified in AD 95-06-53 will not be used in the configuration of the new rudder control system required by this AD.

• AD 97-05-10, applicable to all Boeing Model 737 series airplanes, requires removal of the main rudder PCU and replacement with a serviceable unit. That AD corrects an unsafe condition due to an unapproved Hi-Lock bolt that was installed in the lever assembly bearing of the main rudder PCU instead of the correct bolt. However, the PCUs identified in AD 97-05-10 will not be used in the configuration of the new rudder control system required by this AD.

• AD 97-09-15 R1, applicable to all Boeing Model 737-100, -200, -300, -400, and -500 series airplanes, requires a one-time inspection to determine the part number of the engage solenoid valve of the yaw damper on the rudder PCU, and replacement of the valve with a valve having a different part number, if necessary. However, the engage solenoid valves specified in AD 97-09-15 R1 will not be used in the configuration of the new main rudder PCU required by this AD.

• AD 98-02-01, applicable to all Boeing Model 737-100, -200, -300, -400, and -500 series airplanes, requires removing the yaw damper coupler; replacing its internal rate gyroscope with a new or overhauled unit; and performing a test to verify the integrity of the yaw damper coupler, and repair if necessary. However, that configuration of the yaw damper coupler, using mechanical rate gyroscopes, is no longer approved for installation on Model 737 series airplanes. Instead, AD 97-14-03, amendment 39-10060 (62 FR 34623, June 27, 1997), requires, among other things, installation of a new yaw damper system that replaces the gyroscopes specified by AD 98-02-01. That new system is intended to prevent malfunction of the yaw damper system.

• AD 99-11-05 COR, applicable to all Boeing Model 737 series airplanes, requires repetitive displacement tests of the secondary slide in the dual concentric servo valve of the PCU for the rudder; and replacement of the valve assembly with a modified valve assembly, if necessary. However, the dual concentric servo valve of the PCU for the rudder, which was specified in AD 99-11-05 COR, will not be used in the configuration of the main rudder PCU that will be installed as a component of the new rudder control system required by this AD.

Interested persons have been afforded an opportunity to participate in the making of this amendment. One commenter supports the proposed rule. Due consideration has been given to all comments received.

One commenter considers that an adequate level of safety has been achieved by the accomplishment of AD 97-14-04 and AD 2000-22-02 R1, which are referenced in the Discussion paragraph of the proposed rule, and by the accomplishment of ADs 95-06-53, 97-05-10, 97-06-09, 97-09-14, 97-09-15, 97-14-03, 98-02-01, and 99-11-05. The commenter states that since accomplishing the modifications required by AD 97-14-03 and AD 97-14-04, no instances of uncommanded rudder movement have occurred. In addition, no discrepancies were found by the PCU manufacturer during numerous displacement tests conducted per AD 99-11-05. Further, the proposed rule identifies multiple conditions that only theoretically could occur with the existing rudder control system. After reviewing this information, we infer that the commenter is requesting withdrawal of the proposed rule.

The FAA does not concur with the commenter's request to withdraw the proposed rule. As explained in the proposed rule, the unsafe condition is due to inherent failure modes, including single-jam modes and certain latent failures or jams, which, when combined with a second failure or jam, could cause an uncommanded rudder hardover event and consequent loss of control of the airplane. Because the identified inherent failure modes have not been eliminated by the actions required by those previously issued ADs, we have determined that the actions required by this final rule are warranted. This determination was made after considering the existence of these failure modes and the need for a unique operational procedure (per AD 2000-22-02 R1). No change to the final rule is necessary in this regard.

One commenter, the manufacturer, does not agree that the unsafe condition identified in the proposed AD exists in the current Model 737 rudder control system for the following reasons:

• The current rudder control system is safe and has been shown to meet all current regulations using accepted industry analysis and validation practices.

• Service experience accumulated over 116 million flight hours demonstrates that the system is safe; the airplane has one of the lowest accident rates of airplanes in its class.

• All issues identified as potential safety issues have been addressed by service bulletins mandated by the following airworthiness directives issued by the FAA: AD 97-14-03; AD 97-14-04; AD 97-26-01, amendment 39-10244 (62 FR 65597, December 15, 1997); and AD 98-13-12, amendment 39-10600 (63 FR 33246, June 18, 1998).

• The 737 Flight Controls ETEB report did not identify any new significant failure modes or unsafe conditions that invalidate previous Model 737 certification documentation. All failure modes in the ETEB report had been previously identified and analyzed by the manufacturer. The existing rudder system is considered safe and meets federal regulations.

While the manufacturer does not agree that the unsafe condition exists, it states that it is committed to a redesign of the Model 737 rudder control system to further enhance an already safe system. The manufacturer also states that the new design will eliminate certain potential latent failures in the system, even though evaluation in accordance with federal regulations has shown such latencies to be acceptable. The elimination of such failures will enable the system to be functionally equivalent to a three-actuator system. The new system also will eliminate the need for the existing uncommanded rudder non-normal operational procedure unique to Model 737 series airplanes.

While the ADs identified by the manufacturer were issued to address previously identified unsafe conditions, we have determined that the inherent failure modes identified in this AD have not been eliminated by the actions required by those ADs. Therefore, we do not agree with the manufacturer's conclusion that the existing design of the rudder control system is safe. As described in the proposed AD, the unsafe condition is due to inherent failure modes, including single-jam modes, and certain latent failures or jams, which, when combined with a second failure or jam, could cause an uncommanded rudder hardover event and consequent loss of control of the airplane.

Likewise, AD 2000-22-02 R1 provides instructions to the flightcrew for addressing certain rudder system failures, but those instructions will not be effective in preventing an accident if the rudder control failure occurs during takeoff or landing.

After considering all of this information, we have determined that it is necessary to issue this AD to eliminate the unsafe condition by mandating the installation of a newly designed rudder control system. The new system will incorporate design features that will increase system redundancy, and will add an active fault monitoring system to detect and annunciate to the flightcrew single jams in the rudder control system. If a single failure or jam occurs in the linkage aft of the torque tube, the new system will allow the flightcrew to control the airplane using normal piloting skills, and without using operational procedures that are unique to this airplane model. In light of this, we consider that the actions specified in this final rule are warranted. No change to the final rule is necessary in this regard.

One commenter, the NTSB, requested more information on the system safety assessment (SSA) being conducted in support of the design changes for the proposed new rudder control system. To help evaluate the new design, the commenter would like to review the analyses being conducted for each design, the reliability benefits, and other rudder actuation system designs that were submitted.

The commenter also stated the following concerns about the new system:

• It does not provide full independence for the main PCU, and “it would appear that true redundancy would require two fully independent PCUs.”

• The automatic activation system for the standby PCU may increase the number of possible failure modes compared to the installation of a third full-time independent PCU.

• Without the SSA information, the commenter states that it is unable to determine if the revisions to the rudder actuation system of the Boeing Model 737 series airplanes will sufficiently address safety concerns.

We cannot provide the requested SSA information or other requested design information because it is proprietary to The Boeing Company. However, we have sent the commenter's request to Boeing. Boeing has informed us that it has briefed the NTSB on the Rudder System Enhancement Program on January 16, 2001, and on March 18, 2002. To the extent that the commenter expresses an interest in certification documentation, Boeing will submit the SSA results to us for our approval as part of the certification of the new design.

The commenter also expressed a concern that true redundancy would require two fully independent PCUs. During our reviews of the new rudder control system, we have found that the new main rudder PCU design is equivalent to two independent PCUs. The main rudder PCU is an assembly with two PCUs arranged in tandem. The new main rudder PCU will have two independent servo valves in lieu of the existing common dual concentric servo valve. Two separate input linkages will control the position of these valves on the main rudder PCU. The pilot can override each of these input linkages and also override the linkage for the standby PCU. The function of the override capability is to enable the pilot to control the airplane in the event of a jam in any one of the three input linkages or associated servo valves in the rudder control system.

Finally, the commenter expressed concerns that the automatic activation system for the standby PCU may increase the number of failure modes, compared to the installation of a third full-time independent PCU. In addressing this concern, we note that introduction of a third full-time PCU for a single flight control surface would introduce latent failure modes. With three active PCUs, a single PCU failure (due to a valve jam or linkage failure) can remain latent while the other two PCUs control the rudder surface position. Typically, rudder control systems with three active PCUs require frequent periodic maintenance to detect a single failure, or require a fault-monitoring and annunciation system.

The introduction of any fault-monitoring system will increase the number of failure modes due to increased system complexity. Although the fault-monitoring system for the new rudder control system slightly increases the number of failure modes, these failure modes would not have any adverse effect on the operation of the rudder control system. However, this new system will provide significant benefits in the capability to detect certain failures, provide crew annunciation, and activate the standby rudder PCU. When the standby rudder PCU is activated along with the main rudder PCU, there will be effectively three PCUs controlling the rudder surface position.

In light of this information and based on our certification activities, the new rudder control system will adequately address the identified unsafe condition. No change to the final rule is necessary in this regard.

One commenter suggested that electromagnetic interference may have contributed to reported events of uncommanded rudder movement on Boeing Model 737-100, -200, -300, -400, and -500 series airplanes. However, the commenter concluded that, if this is true, those airplanes have already been fixed by previously mandated changes to the yaw damper system.

We do not concur with the commenter's suggestion or conclusion. The only electrical components in the rudder control system are in the yaw damper system. The existing rudder yaw damper system has mechanical stops that limit rudder movement to the yaw damper authority. In a normally functioning system, it is not possible for electrical interference to move the rudder beyond the mechanical stops. No change to the final rule is necessary in this regard.

Several commenters request revising the proposed compliance time of 5 years, and two commenters suggest a new compliance time of September 2008. In addition, several commenters recommend basing the compliance time on the completion of tests for the new main rudder PCU, receipt of service bulletins, operators' maintenance schedules, and parts availability. Additional recommendations and FAA responses are described as follows:

• One commenter states that wiring kits should be available in the second quarter of 2002, but actual hardware won't be available until the year 2003. In addition, because of the number of affected airplanes (about 150) in the commenter's fleet, the proposed 5-year compliance time will not be sufficient to accomplish the required actions if receipt of the service bulletins and parts are delayed for 2 years.

• One commenter suggests extending the compliance time to 10 years, and states that the extensive modifications required by the proposed rule are best suited for accomplishment at a D-check.

• One commenter is concerned about parts availability and a possible schedule slide. The commenter states that the manufacturer projects a maximum production capacity of 100 PCUs per month, with about 75 of those units available for retrofit each month after airplane production line requirements are met. In addition, if PCU certification and production proceed on schedule, a maximum of 3,300 airplanes could be retrofitted within 44 months, which would be insufficient to meet 27 percent of potential worldwide demands. The commenter is concerned that, if PCU certification or the production schedule should slide, the schedule for providing sufficient parts would be adversely affected.

• One commenter, the manufacturer, justifies its request for a September 2008 compliance time by noting the benefits of a slower introduction to the retrofit program. The manufacturer states that the FAA made assumptions in the proposed AD based on estimates for retrofitting U.S.-registered airplanes (about 2,000). However, the manufacturer notes that it must plan for retrofitting the worldwide fleet (about 4,500 airplanes). In addition, because the proposed changes to the rudder control system will require modifications throughout the airplane, the manufacturer recommends the September 2008 compliance time to allow for a phased approach for the retrofit program, thereby providing the time necessary to correct any issues identified during the first retrofits.

We partially concur with the commenters' requests to revise the compliance time. We have considered the commenters' suggestions and concerns, and have made the following determinations. We concur with the requests to revise the compliance time to the year 2008, but do not concur with the request to extend the compliance time to 10 years. We agree that the 5-year compliance time required by the proposed rule may not allow operators sufficient time to accomplish the required design modifications. We also agree that the new compliance time should take into consideration when the service bulletins will be issued and when the required parts will be made available to the operators.

In addressing the concerns about delays in the issuance of service bulletins, insufficient parts, and sliding schedules, the manufacturer has established a firm schedule and has assured us that all service information and parts will be provided within the required 6-year compliance time to support the new rudder control system. The manufacturer also has established backup plans to further ensure that parts will be available to meet schedule deadlines. To date, the manufacturer has informed us that the necessary service information is being developed and will be issued according to schedule, and that all necessary parts are being manufactured and will be available per the schedule. Further, we will closely monitor the manufacturer's schedule to ensure that all service information and parts are provided to the operators on time.

In making our determination to extend the compliance time from 5 to 6 years, we also have taken into consideration the service record of Model 737 series airplanes since the accomplishment of the modifications required by AD 97-14-03 and AD 97-14-04. In light of all of this information, we have determined that a compliance time of 6 years will provide sufficient time for affected operators to install the new rudder control system without adversely affecting safety. Paragraph (a) of the final rule is revised accordingly.

Although several commenters support the intent of the proposed AD, the commenters request delaying issuance of the proposed rule. The specific comments are described as follows:

• The Air Transport Association (ATA) of America, on behalf of some of its members, recommends delaying issuance of the proposed rule until after the new main rudder PCU is tested and certified, and after the service information is issued by the manufacturer and approved by the FAA. Although service bulletins for the wiring installations for certain airplanes were issued in February 2002, issuance of additional service bulletins are not expected until the third quarter of 2002. In addition, service information for PCU procedures is not expected until July 2003. ATA is concerned about the risks associated with mandating the proposed actions before completing test and evaluation procedures for the new rudder control system, and about the limited number of retrofit kits that will be available each month.

• One commenter strongly recommends waiting to issue the proposed rule until the relevant Boeing service bulletins and required parts are available. As noted earlier in the “Requests to Revise the Compliance Time” paragraph of this AD, that same commenter stated that, although the wiring kits would be available in the second quarter of 2002, actual hardware would not be available until the year 2003.

• Two commenters consider that the proposed rule should be issued after the new rudder control system has been tested and approved. Issuing the proposed rule before approval of the system does not allow operators the opportunity to evaluate and comment on the system. Requiring installation of an unknown system places an undue burden on operators, since procedures for the corrective action are not yet defined.

We do not agree that issuance of this AD should be delayed. The manufacturer has assured us that the compliance time specified by this AD will allow sufficient time to design, test, and evaluate the new rudder control system. As described earlier, we are monitoring the manufacturer's schedule for issuing the required service information and providing parts, and we will strive to ensure that the parts and information will be provided to the operators so that they can meet the requirements of this AD.

We infer from the commenters' requests to delay issuance of the final rule that the commenters are seeking more time to comply with the rule. In this regard, we partially concur, and, as described earlier in this AD, have extended the 5-year compliance time specified in the proposed AD to 6 years. The manufacturer has assured us that, in addition to the wiring service information issued in February 2002, it will provide all additional service information (including PCU procedures) and parts necessary to meet the requirements of this AD. In addition, the new rudder control system, including all necessary components for the system, will be thoroughly tested and evaluated prior to issuance of the service information. No change is made to the final rule in this regard. As described earlier, paragraph (a) of the final rule specifies the new compliance time of 6 years after the effective date of this AD.

One commenter states that the proposed costs are substantial ($184,000 per airplane, or $364 million for U.S. operators).

We recognize that the costs for the new rudder control system are substantial. However, in determining the costs associated with the new rudder control system, we based our cost estimate on the manufacturer's estimate of 700 work hours per airplane for the installation of the new rudder control system, and our estimate of approximately $140,000 per airplane for parts. For reasons specified in the proposed AD, we have determined that an unsafe condition exists, and we consider that accomplishment of the requirements of this AD is necessary to address that identified unsafe condition. No change is made to the final rule in this regard.

One commenter considers that any new proposed rule should supersede the ADs listed in the following table and described below:

• Asterisks in the preceding table indicate the following changes since the issuance of those ADs:

• AD 97-09-14 was superseded by AD 2000-02-18, amendment 39-11536 (65 FR 5238, February 3, 2000).

• AD 97-09-15 was revised by AD 97-09-15 R1, amendment 39-10912 (63 FR 64857, November 24, 1998).

• AD 99-11-05 was corrected by AD 99-11-05 COR, amendment 39-11175 (64 FR 27905, May 24, 1999).

The commenter adds that incidents of uncommanded rudder movement were reported on airplanes prior to the accomplishment of AD 97-14-03 and AD 97-14-04; however, no incidents have occurred since the accomplishment of those ADs. In addition, the manufacturer of the main rudder PCU has accomplished 361 displacement tests per AD 99-11-05, and no discrepancies occurred during those tests.

We partially concur with the commenter's request. We have determined that the final rule should supersede the two ADs cited in the NPRM (AD 97-14-04 and AD 2000-22-02 R1) and only five of the ADs listed in the table above (AD 95-06-53, 97-05-10, 97-09-15 R1, 98-02-01, and 99-11-05 COR). (Those five ADs were described in detail in this AD in “Actions Since Issuance of Proposed Rule.”)

However, we do not agree that this AD should supersede AD 97-06-09, AD 97-14-03, or AD 2000-02-18 (which supersedes 97-09-14) because the requirements of those ADs are necessary to correct unsafe conditions that are not addressed by the requirements of this AD. In addition, the components and system specified in AD 97-14-03 are compatible with the new rudder control system and are necessary for the operation of that system. The requirements of those three ADs are described as follows:

• AD 97-06-09, applicable to certain Boeing Model 737-300, -400, and -500 series airplanes, requires replacing certain aileron/rudder trim control modules with an improved module that contains an improved rudder trim switch that precludes the problems of sticking associated with the existing switch. That AD is intended to prevent such sticking.

• AD 97-14-03, applicable to all Boeing Model 737-100, -200, -300, -400, and -500 series airplanes, requires installation of a newly designed rudder-limiting device and yaw damper system. As described earlier in this AD in the “Actions Since Issuance of Proposed Rule” paragraph, AD 97-14-03 supersedes AD 98-02-01 (which requires mechanical rate gyroscopes that are no longer approved for installation on Model 737 series airplanes). The new yaw damper system required by AD 97-14-03 is intended to prevent excessive rudder authority and consequent reduced controllability of the airplane, and malfunctions of the yaw damper system.

• AD 2000-02-18 (which supersedes AD 97-09-14), applicable to certain Boeing Model 737-100, -200, -300, -400, and -500 series airplanes, requires an inspection of reworked aileron/elevator PCUs and rudder PCUs to determine if reworked PCU manifold cylinder bores containing chrome plating are installed, and replacement of the cylinder bores with cylinder bores that have been reworked using the oversize method or the steel sleeve method if necessary. That AD is intended to prevent a reduced rate of movement of the elevator, aileron, or rudder due to contamination of hydraulic fluid from chrome plating chips. Such reduced rate of movement, if not corrected, could result in reduced controllability of the airplane.

We have revised the final rule to supersede the five ADs listed and described in a previous paragraph, “Actions Since Issuance of Proposed Rule.” As discussed previously in this AD, the final rule also supersedes two other ADs.

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

There are approximately 4,500 Model 737 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 2,000 airplanes of U.S. registry will be affected by this AD.

The new installation action that is required by this new AD will take approximately 700 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will cost approximately $140,000 per airplane. Based on these figures, the cost impact of the new requirements of this AD on U.S. operators is estimated to be $364,000,000 (over the proposed 6-year compliance time), or $182,000 per airplane.

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

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

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

On September 13, 2002, the FAA issued airworthiness directive (AD) 2002-19-51, applicable to all Boeing Model 737 series airplanes, to require, for certain airplanes, an inspection to determine whether flight control modules (FCM) having part number (P/N) 65-44891-7 with serial number (S/N) 8726 or greater (hereafter referred to as “suspect FCMs”) are installed, and corrective actions if necessary. The corrective actions include replacing the suspect FCM(s) with a serviceable FCM(s) having P/N 65-44891-7 with a S/N less than 8726, and revising the FAA-approved Airplane Flight Manual (AFM) to include procedures for certain airplanes to identify failures of suspect FCMs before dispatch and to provide the flightcrew with operating procedures in the event of failure of an FCM in flight. The AD also requires certain operators to submit inspection findings to the FAA. That action was prompted by reports of failed FCMs, which resulted in sluggish response of the aileron, elevator, and rudder surfaces. The actions required by that AD are intended to prevent operation with one failed FCM, which could result in reduced controllability of the airplane, or with two failed FCMs, which could result in loss of control of the airplane.

Because of reports of some operators misinterpreting the applicability of AD 2002-19-51, we find that clarification is necessary. Operators should note that this AD affects all Boeing Model 737 series airplanes. Operators of Model 737-600, -700, -700C, -800, and -900 series airplanes, having line numbers 1136 through 1230 inclusive, are subject to all requirements of this AD. However, operators of all Model 737-100, -200, -200C, -300, -400, and -500 series airplanes; and Model 737-600, -700, -700C, -800, and -900 series airplanes, having line numbers other than 1136 through 1230 inclusive; are only required to adhere to paragraphs (j) and (k) of this AD ( i.e. , parts installation paragraphs) to ensure that spare replacement FCMs and compensators identified in those paragraphs are not installed on any Model 737 series airplane in the future. No change to this AD is necessary in this regard.

Since the issuance of AD 2002-19-51, the FAA has approved an alternative method of compliance (AMOC) for the replacement required by paragraphs (d)(1), (d)(2), and (h) of that AD. The AMOC allows FCMs having P/Ns other than 65-44891-7 that are approved for installation on Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes to be installed during the replacements required by those paragraphs. In addition, we have determined that a suspect FCM can continue to be used once the compensator has been replaced with an airworthy compensator. Therefore, we have revised those paragraphs and paragraph (j) of this AD accordingly.

We also have determined that replacement of all suspect FCMs with airworthy FCMs terminates the requirements of paragraphs (e) through (g) of this AD. Therefore, we have revised paragraphs (c) and (d)(1) of this AD accordingly.

We also have revised paragraph (h) of this AD to state explicitly that suspect FCMs that fail during operation of the airplane must be replaced before further flight.

AD 2002-19-51 contains a typographical error in paragraph (k). That paragraph refers to “compensator having P/N 10-605603-3,” which does not exist. The correct P/N of that compensator is “P/N 10-60560-3.” In addition, the airplane manufacturer has provided us with the specific S/Ns ( i.e. , 20478A or greater) of the suspect compensator, P/N 10-60560-3. Therefore, we have revised paragraph (k) of this AD accordingly to prohibit installation of only these S/Ns. We also clarified that unairworthy compensators cannot be installed on any FCM.

Since the unsafe condition described is likely to exist or develop on other airplanes of the same type design, the FAA issued emergency AD 2002-19-51 R1 to prevent operation with one failed FCM, which could result in reduced controllability of the airplane, or with two failed FCMs, which could result in loss of control of the airplane. This AD revises AD 2002-19-51 to continue to require, for certain airplanes, an inspection to determine the S/N of the FCMs having P/N 65-44891-7 and corrective actions if necessary. This AD also continues to require certain operators to submit inspection findings to Boeing. This AD revises the existing AD to provide operators with additional options for compliance, to specify the serial numbers of the affected compensator, and to make other editorial changes.

This is considered to be interim action until final action is identified, at which time the FAA may consider further rulemaking.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual notices issued on September 18, 2002, to all known U.S. owners and operators of all Boeing Model 737 series airplanes. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to §39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-248-AD.” The postcard will be date stamped and returned to the commenter.

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

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

On December 21, 2000, the President signed into law the Commodity Futures Modernization Act of 2000 (“CFMA”) which extensively revises the Commodity Exchange Act (Act) 1 In order to more effectively implement its provisions, the Commission has reorganized its operating divisions. Under the reorganized structure, the Division of Trading and Markets and the Division of Economic Analysis (the former divisions) has been reconfigured into two new divisions, the Division of Clearing and Intermediary Oversight and the Division of Market Oversight (the new divisions), and the Office of the Chief Economist.

The Commission is amending several of its rules in Chapter I of Title 17 of the Code of Federal Regulations to reflect this reorganized structure. Accordingly, as indicated in the chart below, the Commission is deleting from its rules references to the former divisions and replacing them with references to the new divisions. As amended, the rules will reflect the new assignments of responsibilities, including delegated authorities, to the two new divisions.

The Commission is also amending rule 140.99, which governs requests for exemptive, no-action and interpretative letters. Before its amendment, rule 140.99 required all requests to be filed with the Division of Trading and Markets, and thereafter routed to the appropriate office or division. The Commission has determined that it will be more efficient to require the requester to file the request directly with the division with operating responsibility for administering the provision of the Act or of the Commission's regulations from which relief is sought. Accordingly, the Commission is amending rule 140.99 to require that requests relating to certain specific subject matter areas (as enumerated in the amended rule) be filed with the division with operating responsibility for that subject matter area.

The Commission is deleting rule 140.100 which it adopted on July 9, 2002, 67 FR 45299. That rule provided that all delegations of authority from the Commission to the Directors of the former divisions, and their respective designees, as set forth in Chapter I of Title 17 of the Code of Federal Regulations, were delegated jointly to the respective Directors of the new divisions, and their respective designees. Now that the Commission has amended several of its rules to reflect the new agency structure, rule 140.100 is no longer necessary. Finally, the Commission is removing and reserving rules 1.41a, 1.41c and 1.42, which have been superseded by the CFMA 2

The Commission has determined that restructuring of responsibilities, including delegations of authority, relates solely to agency organization, procedure and practice. Therefore, the provisions of the Administrative Procedure Act that generally require notice of proposed rulemaking and that provide other opportunities for public participation are not applicable. 3 The Commission further finds that, because the rules have no adverse effect upon a member of the public, there is good cause to make them effective immediately upon publication in the Federal Register.

In consideration of the foregoing, and pursuant to the authority contained in the Act, and in particular section 2(a)(11) of the Act, 7 U.S.C. 2(a)(11), as amended, the Commission hereby amends Parts 1, 3, 4, 9, 11, 16, 17, 18, 19, 21, 31, 36, 37, 38, 39, 40, 41, 140, 145, 150, 170, 171, and 190 of Chapter I of Title 17 of the Code of Federal Regulations as follows:

1. In the table below, for each section indicated in the left column, remove the words indicated in the middle column from wherever they appear in the section, and add the words indicated in the right column:

Buprenorphine is a semisynthetic opioid. As a derivative of thebaine, buprenorphine was controlled in Schedule II of the CSA in 1970 and remained in Schedule II during its research and development for marketing. In 1981, buprenorphine hydrochloride (Buprenex®) was approved for marketing in the United States as an injectable formulation (0.3 mg/ml) for the treatment of moderate to severe pain. The DEA proposed placement of buprenorphine in Schedule V of the CSA after receiving a medical and scientific evaluation and a Schedule V recommendation from the DHHS. However, buprenorphine was not placed in Schedule V of the CSA until April 1, 1985 (50 FR 8104, February 28, 1985) due to a hearing requested by the manufacturer of buprenorphine, Reckitt & Coleman (now Reckitt Benckiser). Since 1985, Buprenex® has remained in Schedule V. As an injectable analgesic, this product has had limited use outside hospital and clinic settings and is the only buprenorphine product presently marketed in the United States.

In December 2001, the DHHS forwarded a recommendation to reschedule buprenorphine to Schedule III of the CSA. This recommendation was based on a reevaluation of buprenorphine's abuse potential and dependence profile in light of numerous scientific studies and years of human experience with this drug. The DHHS compared buprenorphine with other drugs that share similar pharmacological properties and/or medical utility and considered both foreign and domestic data especially in regard to formulations of buprenorphine that are likely to become available for use in the United States. Two New Drug Applications (NDA) have been submitted to the Food and Drug Administration (FDA) for high dose sublingual (under the tongue) tablets. These potential addiction treatment products include: (1) Subutex®, a mono or single entity buprenorphine product (2 and 8 mg tablets), and (2) Suboxone®, a combination product in a 4:1 ratio of buprenorphine to naloxone (2: 0.5 and 8: 2 mg tablets). The Subutex® and Suboxone® NDAs remain pending at the FDA but approvable letters have been issued for both products and they are likely to receive final marketing approval in 2002. Low dose sublingual tablets (0.1 , 0.2 and 0.4 mg) have been available in numerous countries throughout the world and, in recent years, high dose sublingual tablets (2 and 8 mg) have been introduced in many countries for the treatment of opioid dependence.

After consideration of the DHHS scientific and medical evaluation and Schedule III recommendation, the DEA completed an independent eight factor analysis that included the following factors in accordance with 21 U.S.C. 811(c):

(1) Its actual or relative potential for abuse;

(2) Scientific evidence of its pharmacological effects;

(3) The state of current scientific knowledge regarding the drug;

(4) Its history and current pattern of abuse;

(5) The scope, duration, and significance of abuse;

(6) What, if any, risk there is to the public health;

(7) Its psychic or physiological dependence liability; and

(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

On March 21, 2002, the DEA published a proposed rule to place buprenorphine in Schedule III of the CSA (67 FR 13114). This notice will finalize that proposed rule. Schedule III control requires the DEA to make the following findings in accordance with 21 U.S.C. 812 (b):

1. Buprenorphine has a potential for abuse less than the drugs or other substances in Schedules I and II.

2. Buprenorphine has a currently accepted medical use in treatment in the United States.

3. Abuse of buprenorphine may lead to moderate or low physical dependence or high psychological dependence.

The DEA received comments from ten interested parties. Two commenters were in support of the proposed rule, seven commenters were in opposition to the proposed rule and one individual requested that the DEA be mindful of possible conflicts of interest by individuals/organizations responding to this proposed rule. One commenter felt that Schedule II more accurately reflected the abuse potential and dependence profile of buprenorphine while another commenter felt that the evidence suggests that buprenorphine should remain in Schedule V. Five commenters support differential scheduling of buprenorphine products and contend that the buprenorphine/naloxone product under development has less abuse potential. The following is a listing of all commenters and a brief summary of their comments:

1. The Medical Director of the American Psychiatric Association (APA) commented on behalf of this organization. He stated that the APA supports the proposed rule to reschedule this drug. However, once buprenorphine has been approved for use in opioid substitution treatment, the APA recommends that the DEA study and evaluate the actual abuse over a three-year period to more accurately determine whether placement in Schedule III is appropriate.

2. The President of the American Association for the Treatment of Opioid Dependence (AATOD) submitted comments on behalf of the Board of Directors of AATOD in support of a Schedule III narcotic classification for buprenorphine and its products.

3. The Chair Committee for the Treatment of Opioid Dependence of the California Society of Addiction Medicine (CSAM) and the President of CSAM recommended less restrictive scheduling of the buprenorphine/naloxone combination product (Suboxone®) compared to the mono buprenorphine product (Subutex®) should they be approved for marketing. They believe it is important to convey the message to physicians about the lower risk of abuse and diversion of the combined formulation. They believe that differential scheduling would encourage physicians to appropriately choose the combination product for treatment of addicted patients. No data was provided in support of their contentions.

4. A member of the Board of Directors of the American Academy of Addiction Psychiatry (AAAP) commented on behalf of this organization. The AAAP contends that the available literature and research on buprenorphine do not support the DEA recommendation and recommends differential scheduling of buprenorphine products. Because Buprenex® has been in Schedule V and has not been associated with widespread diversion and abuse, they believe there is no compelling reason to reschedule this medication. Further, they believe there are substantial differences between the two sublingual products intended for addiction treatment. They contend that the buprenorphine/naloxone product is being developed specifically to prevent diversion and illicit injection use. They believe that buprenorphine diversion in other countries has been limited to use by out-of-treatment, opioid dependent, injection drug users. Should both products be placed in Schedule III, they believe that there will be no incentive for physicians to differentially make use of one product. They recommend Schedule V for Buprenex® and Suboxone® and Schedule III for Subutex®. No data was submitted to the DEA in support of these comments.

5. The President of the American Society of Addiction Medicine (ASAM) commented on behalf of this organization. His views also represent those of the Chairmen of ASAM's Medication Development Committee and the Opioid Agonist Treatment Committee. They contend that placing all buprenorphine-containing products into the same schedule is not consistent with the pharmacology and the intended clinical use of the buprenorphine/naloxone sublingual tablets. They believe that sufficient evidence currently exists to support a lower parenteral abuse potential of the combination product as compared to the mono product. They feel that differentially scheduling these addiction medications would encourage physicians to prescribe the naloxone combination product in preference to the mono-product. No data was submitted to the DEA in support of these comments.

6. The President of the College on Problems of Drug Dependence (CPDD) commented on behalf of this organization. This commenter requests that the DEA consider differential scheduling for the potential addiction treatment medications, Suboxone® and Subutex®. She believes there is strong evidence to support differential scheduling: the combination product will lead to lower abuse liability and less parenteral abuse by individuals who are currently dependent on opioids because the naloxone will precipitate withdrawal. The mono-product will not precipitate withdrawal. No data was submitted to the DEA in support of these comments.

7. The President of Reckitt Benckiser Pharmaceuticals, the manufacturer of Buprenex® and the sponsor of the two NDAs for buprenorphine products in the treatment of opioid dependence, does not support the proposed rule for the following reasons:

(a) Little diversion or abuse of buprenorphine has been noted in the United States in the 15 years the product has been marketed.

(b) The DEA has disregarded data on the development of the naloxone combination product that shows significantly less potential for diversion and abuse.

(c) The DEA disregards the additional controls imposed on these newer products by the Drug Addiction Treatment Act of 2000 (DATA).

(d) The Schedule III control for all formulations of buprenorphine would thwart company efforts to ensure that the combination product, if approved, is the primary medication that should be utilized for addiction treatment. By not differentially scheduling these products, the DEA is removing the incentive for physicians to prescribe the combination product rather than the single entity product.

8. The law offices of Hogan & Hartson submitted comments on behalf of a client. Hogan & Hartson requests that DEA enter an order immediately placing buprenorphine and all products containing buprenorphine under Schedule II based on their contention that:

(a) Buprenorphine has a high potential for abuse consistent with the abuse potential of Schedule II drugs. The partial agonist activity, including safety in overdose, is not supported and, even if true, does not warrant a change from the conclusion that buprenorphine has a high potential for abuse.

(b) Safety in overdose is not a relevant factor in deciding if a drug has less abuse potential than other similar drugs.

(c) The DEA failed to consider that the illusion of safety may result in greater potential for abuse.

(d) Scheduling under the CSA is a relative analysis and depends on aligning a drug with the closest set of comparators. Hogan and Hartson believe that the closest set of comparators are Schedule II.

(e) Buprenorphine is a gateway drug which compounds public health risks.

(f) The DEA failed to give adequate weight to the fact that buprenorphine is administered by many routes of administration and in combination with other drugs.

(g) The DEA has not been consistent in its decision making process and has failed to meet the non-arbitrary agency action requirements. The finding that buprenorphine has a potential for abuse less than Schedule I or II substances is arbitrary and capricious and not supported by the underlying administrative record.

(h) The DEA position that buprenorphine most closely resembles Schedule III substances with respect to physical and psychological dependence is contrary to the evidence (even if true, DEA must give greater weight to the abuse potential).

(i) The DEA erred in considering that buprenorphine be available for office-based use as it is not a relevant factor in the scheduling analysis.

(j) Placement of buprenorphine in Schedule III to make it available for office based care will have a significant impact on opioid treatment programs. The DEA is required to analyze this issue and follow the mandate of the Regulatory Flexibility Act.

(k) The CSA requires DEA to make a reasonable predictive judgment about a drug and should not take a reactive posture by stating “should significant abuse or diversion of buprenorphine occur, DEA will initiate actions to increase its regulatory control.”

9. The law offices of Hyman, Phelps & McNamara, P.C. commented on behalf of Purdue Pharma. After reviewing the information that the FDA and the DEA relied upon in order to reach a decision to propose Schedule III placement for buprenorphine, they contend that:

(a) The DEA has not presented an adequate basis for the proposed rulemaking.

(b) The proposed rule has not adequately described the pharmacology of the drug substance buprenorphine or the drug products that would be affected by this rule.

(c) Many facts cited by the DEA and FDA in their conclusions have been removed from their proper scientific context. This is particularly evident in the description of buprenorphine and in the basis for the DEA conclusion that buprenorphine may cause high psychological dependence.

(d) The DEA and FDA have not explained why data generated since the original scheduling action for buprenorphine in 1985 would alter the original conclusions that buprenorphine has a low potential for abuse and low potential for physical and psychological dependence.

(e) The DEA and FDA have inadequately described the conditions of use of Subutex® in France and the impact of such use on either the mortality associated with heroin addiction or the frequency of abuse of buprenorphine. It is asserted without supporting data that the conditions of use that will apply to Suboxone® and Subutex®, should they be approved for use in the United States, will inevitably lead to significant abuse of buprenorphine. There is no discussion of how the proposed use of Subutex® in the United States may differ from the use of this product in France. There is not an acknowledgment in the proposed rule that one of the products under development, which is not available in France, contains naloxone which is expected to deter intravenous abuse.

(f) The additional controls that would be provided by moving buprenorphine to Schedule III are not described and no rationale is provided for the assertion that the Drug Addiction Treatment Act will not provide adequate safeguards for the public health.

(g) The overwhelming scientific and medical evidence demonstrates that buprenorphine should not be rescheduled. If buprenorphine is rescheduled it should not be placed any higher than Schedule IV.

1. The Director of the Edmond de Rothschild Foundation, Chemical Dependency Institute of Beth Israel Medical Center in New York City, urged the DEA to assess possible conflict of interest of individuals/organizations submitting comments on the proposed rule to place buprenorphine in Schedule III of the CSA.

The DEA has thoroughly reviewed, analyzed and considered all the comments submitted in response to the proposed rule to place buprenorphine into Schedule III of the CSA. Most commenters averred that the DEA failed to consider data that demonstrates that buprenorphine has a lower (or higher) abuse potential/dependence profile than Schedule III substances. In most instances, no data was provided to support these contentions. Two commenters, however, provided data that they relied upon in opposing the proposed rule. The relevant data cited by these commenters were available to and considered by DHHS and DEA in deliberations regarding the proposal to reschedule buprenorphine. In several cases, the same medical, scientific and other data cited by FDA and/or DEA in scheduling review documents are interpreted differently by the commenters.

Fundamental to all of the comments in opposition to the proposed rule is the belief that buprenorphine and/or products containing buprenorphine have an abuse potential and dependence profile other than Schedule III. The following is a brief summary of the data used by the DEA to conclude that the most appropriate placement for buprenorphine and products containing buprenorphine is in Schedule III of the CSA classified as a narcotic. Following this summary (under the headings of Abuse Potential of Buprenorphine and Dependence Profile of Buprenorphine), specific questions or comments raised by the commenters are addressed.

The evaluation of the abuse potential of any substance considers a number of factors including (but not limited to) its chemistry (including ease of synthesis and evidence of clandestine production), pharmacology (including routes of administration, profile of effects under various conditions and populations, duration of action, drug interactions), intended use, populations at-risk of abuse and actual abuse data. The subjective effects (alterations in mood, feeling and thinking) produced by a drug may lead to reinforcement of drug-taking behavior and abuse (Jasinski, 1991). The abuse potential criteria under the CSA is a relative one with Schedule I and II requiring substances to have a high abuse potential and Schedule III, IV and V substances having progressively lower abuse potentials. This necessitates the comparison of the abuse potential of the substance under review with other substances. Morphine, a Schedule II substance with high abuse potential, is often used as a standard for comparing the effects produced by other opiates; the more an opiate/opioid is morphine-like as perceived by the user, the more likely the substance, if available, will be abused.

Buprenorphine is a semi-synthetic opioid derived from thebaine. It has high affinity for, low intrinsic activity at, and slow dissociation from opioid receptors (for review see Johnson & McCagh, 2000). These properties contribute to its protracted occupancy at opioid receptors.

Buprenorphine is a partial agonist (activator) at the mu-opioid receptor and an antagonist (blocker) at the kappa-opioid receptor (Richards and Sadee, 1985; Sadee et al. , 1982). Mu receptor activation is associated with analgesia, miosis (pupillary constriction), respiratory depression, euphoria, reduced gastrointestinal motility and dependence. Kappa receptor activation produces analgesia, miosis, sedation, dysphoria and psychotomimetic effects including disorientation and/or depersonalization. As a partial agonist at the mu receptor, buprenorphine produces effects similar to pure mu agonists (like morphine) but effects are less dose-dependent producing a “ceiling effect” on both physiological and psychological properties: dose increases above the “ceiling dose” do not produce greater effects (Pickworth et al. , 1993; Walsh et al. , 1994, 1995). Various effects produced by buprenorphine have different ceiling doses. At clinically relevant doses, the “ceiling” for some effects produced by buprenorphine administration may not be reached. As a consequence, buprenorphine may act more like a pure mu agonist (depending on dose, effect being measured and individual variability) and may produce significant dose-related euphoria, drug liking, respiratory depression and sedation over a wide range of doses ( see citations below). However, buprenorphine's unique pharmacology results in greater safety (less respiratory depression at very high doses), less physical dependence and greater flexibility in dose scheduling than pure mu agonists such as morphine (Johnson & McCagh, 2000).

Although poorly available by the oral route due to poor absorption and extensive metabolism in the small intestine and liver, buprenorphine can be taken sublingually (Walter et al. , 1996). As a drug of abuse, tablets have been crushed and snorted, smoked and placed in aqueous solutions and injected (for example: Strang, 1985, 1991; Gruer et al. , 1993; Kintz, 2001). The absolute bioavailability of sublingual tablets is approximately 30 percent when the extent of absorption of a sublingual solution is compared to an intravenous dose (Mendelson et al. , 1997a). Dissolving buprenorphine in aqueous alcohol enhances sublingual absorption: the bioavailability of the tablet is about 50 percent that of a sublingual aqueous alcohol solution containing equivalent amounts of buprenorphine (Nath et al. , 1999; Schuh et al. , 1999a). This difference in the bioavailability of sublingual aqueous alcohol solutions and sublingual tablets of buprenorphine may account for some of the variability in data involving dose effects. Data generated using animal models suggest that buprenorphine may have relatively high bioavailability in humans by the intranasal route (Brewster et al. , 1981; Lindhardt et al. , 2000).

The more ways a drug can be administered by various populations of abusers increases its likelihood to be abused. Individuals that only abuse pharmaceuticals by swallowing tablets or liquids (like most abusers of hydrocodone products) would be less likely to abuse buprenorphine. At the same time, the lack of oral bioavailability increases the likelihood that buprenorphine will be abused in a manner that enhances its reinforcing effects. Abuse data indicates that buprenorphine is often injected. While heroin addicts and experienced narcotic abusers have been the primary abusers of buprenorphine, data from England, France, Scotland, and Ireland demonstrate that, if available, buprenorphine is abused by young, non-dependent drug abusers (Coggans et al. , 1991; Forsyth et al. , 1993; Frischer, 1992; Hammerseley et al. , 1990; O'Connor et al. , 1988).

The DEA has no evidence that buprenorphine is clandestinely produced; diverted pharmaceutical products are the only source of this drug for those who would choose to abuse it. Like all substances with abuse potential, the greater the availability of buprenorphine (greater use due to new dosage forms and new indications) the more likely it will be abused. High-dose, sublingual tablets intended for narcotic treatment and utilized outside the constraints of traditional narcotic treatment programs increases the risk that these products will be diverted, trafficked and abused. Simply stated, providing an abusable substance to known drug abusers imparts enhanced risks. While little diversion and abuse of the injectable formulation, Buprenex®, has occurred in the United States, the circumscribed use (few prescriptions and primary use in hospital settings) has limited the availability of this substance for abuse purposes. Recent increases in the use of Buprenex® may be related to the use of this product for narcotic treatment and detoxification: IMS National Disease and Therapeutic Index data and DEA field office reports indicate that many doctors are illegally using Buprenex® for narcotic treatment and detoxification. The Drug Addiction Treatment Act of 2000 (DATA) does not apply to Buprenex® as it has not been approved by the FDA for use in narcotic treatment.

Drug discrimination studies are among the most rigorous laboratory procedures for assessing the substitutability of psychoactive drugs and provide valuable information about the subjective effects produced by a drug (Schuster & Johanson, 1988). In drug discrimination studies, buprenorphine generally substitutes for mu agonists across several animal species including humans (for example: Leander, 1983; France et al. , 1984; Young et al, 1984; France & Woods, 1985; Hoffmeister, 1988; Picker & Dykstra, 1989; Negus et al. , 1990; Preston et al. , 1989, 1992; Bigelow and Preston, 1992; Paronis & Holtzman, 1994; Walker et al. , 1994). These studies suggest that buprenorphine shares more similar effects with pure mu agonists than with prototypic partial agonists (like butorphanol and pentazocine that are in Schedule IV of the CSA). For example, Preston & Bigelow (2000) conducted a drug discrimination study in adult males with histories of opioid abuse (but not physically dependent at time of study) trained to discriminate hydromorphone (a Schedule II pure mu agonist) from placebo (saline). Of the partial agonists tested (buprenorphine, butorphanol, pentazocine and nalbuphine) only buprenorphine fully substituted for hydromorphone and produced dose-related increases in hydromorphone-appropriate responses. Pentazocine showed an inverted U-shaped dose-response curve while butorphanol and nalbuhine did not substitute for hydromorphone at any dose tested.

The subjective effects of buprenorphine, with or without naloxone, have been studied under a wide range of conditions including study subjects, dose ranges, routes of administration and timing intervals. In addition, opiate or naloxone challenge in buprenorphine maintained clients vary significantly with study conditions. Despite the methodological differences in these studies, certain conclusions can be made regarding the abuse potential of buprenorphine (with or without naloxone) in different populations of users. The following represents a sampling of those studies.

Studies conducted in non-drug abusers (for example: Manner et al. , 1987; Saarialho-Kere et al. , 1987; MacDonald et al. , 1989; Fullerton et al. , 1991; Zacny et al. , 1997) indicate that buprenorphine, like morphine, produces dose related impairment of psychomotor performance, euphoria, miosis, respiratory depression, somnolence and nausea. In studies with non-dependent, opioid-experienced subjects, the most consistent finding with buprenorphine administration (sublingual, intravenous, intramuscular, subcutaneous) is a dose-related increase in “drug liking” and “good drug effects” over a wide range of doses (for example: Jasinski et al. , 1978; Preston et al. , 1992; Weinhold et al. , 1992; Pickworth et al. , 1993; Preston and Bigelow, 1994; Foltin and Fischman, 1996; Greenwald et al. , 1999; Strain et al. , 2000; Comer et al. , 2002). In opioid dependent subjects, buprenorphine can substitute for heroin. Clinical data indicate that when equipotent doses of buprenorphine and methadone are used, buprenorphine is as effective as methadone in suppressing opioid withdrawal (Bickel et al. , 1988; Johnson et al. , 1992). Jasinski et al. (1978) reported that chronic subcutaneous administration of a daily dose of 8 mg of buprenorphine produces morphine-like subjective effects and euphoria equivalent to 30 mg of morphine sulfate administered four times daily. In a sample of experienced detoxified opiate abusers, Bedi et al (1998) examined the abuse liability of 0.6 mg of buprenorphine, 16 mg morphine and 30 mg pentazocine. Buprenorphine produced significant euphoria and was identified as heroin rather than pentazocine. In a study with opiate-dependent heroin abusers, intravenous administration of 2 mg of buprenorphine produced potent opiate agonist effects (Mendelson et al. , 1996). Seven of eight subjects estimated that this dose of buprenorphine had a street value between $5 and $20 but of lesser value than heroin. In subjects maintained on daily sublingual buprenorphine (8 mg), intramuscular injections of buprenorphine (4, 8, 16 mg) produced opioid agonist-like effects (Strain et al. , 1997). Collectively, these data suggest that buprenorphine has abuse potential in a wide spectrum of individuals. Vulnerable populations include drug naive individuals (new drug abusers), opiate experienced individuals and opiate dependent individuals.

Many of the comments to the proposed rule for buprenorphine rescheduling expressed concern about placing the buprenorphine/naloxone combination product in the same schedule as single entity products. They contend that the combination product has significantly less abuse potential warranting lesser control. However, the data regarding naloxone and buprenorphine/naloxone administration in various populations of users does not support a lower schedule.

Naloxone is an opioid antagonist that acts competitively at opioid receptors. It is used to reverse opioid central depression, including respiratory depression (the leading cause of death in narcotic overdoses), and has been given intravenously to precipitate withdrawal symptoms in the diagnosis of opioid dependence. It is generally injected and has a short duration of action. Taken sublingually, naloxone has little bioavailability.

The buprenorphine/naloxone combination product was specifically developed to inhibit intravenous abuse by heroin addicts. In theory, the injection of buprenorphine/naloxone combination in opioid-dependent subjects should precipitate a moderate to severe withdrawal syndrome similar to abrupt withdrawal from opioids. This withdrawal syndrome develops within minutes of injection and subsides in one to two hours. However, a substantial percentage of individuals currently abusing heroin or other opiates do not show any evidence of withdrawal when challenged with naloxone. Between 34 and 61 percent of patients applying for methadone maintenance may have minimal or no response to intravenous or intramuscular naloxone in doses ranging from 0.2-1.2 mg (Blachly, 1973; Judson et al. , 1980; Kanof et al. , 1991; Peachy and Lei, 1988; Zilm and Sellers, 1978). While addicts that seek treatment may have very high levels of psychological dependence, this data suggest that they may not have high levels of physical dependence on narcotics.

The extent of withdrawal associated with injection of buprenorphine/naloxone combination, should it occur, is directly related to the buprenorphine/naloxone dose and the level of dependence of the subjects. For example, individuals maintained on 30-60 mg of methadone (Strain et al. , 1995; Mendelson et al. , 1997) or 60-120 mg intramuscular morphine (Mendelson et al. , 1999; Fudala et al. , 1998; Schuh et al. , 1996), opiate doses likely to produce significant physical dependence, experience an unpleasant opioid withdrawal syndrome after injection of low doses of naloxone or buprenorphine/naloxone. Mendelson et al. (1999) studied the effects of three intravenous buprenorphine and naloxone combinations on agonist effects and withdrawal signs in 12 opiate-dependent subjects. Following stabilization on a daily dose of 60 mg morphine intramuscularly, subjects were challenged with buprenorphine alone (2 mg intravenously) or in combination with naloxone in ratios of 2:1, 4:1, and 8:1 (1, 0.5, and 0.25 mg of naloxone). Buprenorphine alone did not precipitate withdrawal and produced effects similar to morphine. Dose-dependent increases in withdrawal signs and symptoms and a decrease in opioid agonist effects occurred after all naloxone combinations. At the 4:1 ratio (that which has been chosen for the marketing of the combination product), opioid agonist effects were attenuated by about 50 percent and unpleasant effects were observed for about 30 minutes. These data suggest that injection of the combination buprenorphine/naloxone product has less abuse potential in non-buprenorphine opiate-dependent addicts.

In New Zealand, the only country that has marketed a buprenorphine/naloxone combination product, extensive intravenous abuse of the 0.2 mg buprenorphine tablet among opiate abusers led to the 1991 reformulation of buprenorphine to include 0.17 mg of naloxone. Robinson et al. (1993) conducted two separate surveys among narcotic addicts presenting for treatment before and after the launch of the naloxone combination product. In 1990, 81 percent of the patients reported intravenous buprenorphine abuse in the previous 4 weeks, 50 percent reported exclusive use of buprenorphine and 65 percent tested positive for the drug. In 1991, 57 percent reported intravenous abuse of the combination tablet and 43 percent tested positive for the combination. One third of the patients that used the combination product intravenously reported instances of withdrawal symptoms. Only one patient reported exclusive use (by injection) of buprenorphine/naloxone and experienced no adverse withdrawal effects. The authors concluded that the combination product did act as a deterrent for some drug abusers but did not stop injection practices. In addition, the authors noted that the injection of the combination product would not produce withdrawal symptoms (act as a deterrent) in individuals who were not physically dependent on narcotics or those who were physically dependent on buprenorphine.

Injection of buprenorphine/naloxone in opioid naive individuals, non-dependent opioid abusers or buprenorphine maintained addicts will likely result in opioid agonist effects. For example, intramuscular administration of buprenorphine alone (0.4 and 0.8 mg/70 kg) or in combination with naloxone (0.4 and 0.8 mg/70 kg) was examined in seven non-physically dependent opioid abuser volunteers (Weinhold et al, 1992). In subjective measures of drug effects, buprenorphine alone produced dose dependent increases in “drug liking”, “high”, and agonist ratings. Administration of 0.4 mg buprenorphine in combination with 0.4 mg naloxone produced positive subjective opiate effects greater than 0.4 mg of buprenorphine alone and a greater percentage of subjects identified the naloxone-buprenorphine combination as an opiate when compared to buprenorphine treatment alone. However, increasing the naloxone concentration to 0.8 mg (twice the concentration of buprenorphine) significantly reduced opioid agonist effects.

In another study with opioid-dependent volunteers stabilized on 8 mg/day sublingual buprenorphine, intravenous buprenorphine (8 mg) with naloxone (4 or 8 mg) produced subjective effects similar to 8 mg sublingual buprenorphine and did not precipitate withdrawal (Harris et al. , 2000). Buprenorphine's high affinity for opioid receptors prevents naloxone from displacing buprenorphine already bound to these sites. In some populations of buprenorphine-maintained clients, extremely high intravenous doses of naloxone are required to even partially displace buprenorphine from opioid receptors (Koston et al. , 1990).

In non-dependent opioid abusers, sublingual administration of buprenorphine/naloxone (1/0.25, 2/0.5, 4/1, 8/2, 16/4 mg) produced opioid agonist-like effects (Strain et al. , 2000).

The data suggest that the buprenorphine/naloxone combination products will likely produce an unpleasant withdrawal when injected by heroin-dependent subjects. However, this combination drug product will not be a serious deterrent to injection by marginally or non-physically dependent users or by individuals stabilized on this medication for addiction treatment (those individuals that will probably have the greatest access to this drug) or by injecting addicts who are abusing and dependent on buprenorphine. In addition, this combination product, taken sublingually, is not a deterrent for abuse by most populations. Studies on snorting and smoking this combination are not available.

One of the many objectives of opioid replacement therapy for addiction treatment is to deter addicts from the continued use of heroin or other opiates. Chronic buprenorphine dosing produces cross-tolerance to other opioids (Jasinski et al. , 1978; Bickel et al. , 1988) and may limit the magnitude of effects produced by supplemental challenges of other opioids.

In subjects maintained on a sublingual dose of 8 mg/day of buprenorphine, acute supplemental intramuscular doses of buprenorphine (4, 8 and 16 mg) or hydromorphone (9 and 18 mg) administered 16 hours after the buprenorphine daily dose produced opioid agonist effects although there was a lack of graded dose-effects for hydromorphone (Strain et al. , 1997). The addition of naloxone to the maintenance dose of buprenorphine does not impart greater blockade (Strain et al. , 2002).

In a study to determine what dose of buprenorphine would effectively block the reinforcing effects of intravenous heroin (Comer et al. , 2001), both 8 and 16 mg of sublingual buprenorphine maintenance dosing failed to block the effects of 12.5 mg or 25 mg of heroin. These data indicate that buprenorphine maintenance (even at relatively high maintenance doses) may not serve as a deterrent for patients who chose to continue their illicit use of heroin or other opiates.

Buprenorphine has been diverted, trafficked and abused in many countries throughout the world. Starting in the late 1970s, low-dose buprenorphine sublingual tablets and injectable solutions were approved for marketing in many countries. High-dose buprenorphine for narcotic treatment gained marketing approval in France in 1996 and has since been approved in several other countries.

Buprenorphine abuse was detected in many countries soon after it was approved for marketing. The initial profile of low abuse liability and high therapeutic index (safety) fueled decisions that allowed the initial marketing of buprenorphine without any significant restrictions or regulatory controls. Its easy accessibility and acceptability by a wide spectrum of drug abusers, including heroin addicts, resulted in substantial abuse (for example: Levelle et al. , 1991; Rainey, 1986; Strang, 1995,1991; Tracqui et al. , 1998; Kintz, 2001; Basu, 1998; Robinson et al. , 1993; Dore et al. , 1997, Singh et al. , 1992; Chowdhury et al. , 1998). Austria, Australia, Belgium, Germany, France, India, New Zealand, Norway and Sweden have all increased the regulatory controls on buprenorphine. In 1988 the World Health Organization (WHO) recommended that buprenorphine be placed in Schedule III of the Psychotropic Convention. This action was taken by the United Nations in 1989.

A number of factors have contributed to the illicit use of buprenorphine. In areas where heroin has been less available or of low quality, buprenorphine's low cost, easy accessibility, high purity and substantial morphine-like effects have contributed to its popularity on the illicit market. Doctor shopping and forged prescriptions are important sources of this drug and, according to the International Narcotics Control Board (INCB), large quantities of buprenorphine have been trafficked across international borders.

While extensive diversion, trafficking and abuse have been documented for both the sublingual tablets and injectable formulations, the sublingual tablet has a greater appeal to a wider range of drug abusers. The variety of routes of administration may account for this preference. The tablets can be abused by the sublingual route or they can be crushed and snorted or the powder can be solubilized and injected.

In summary, unlike Schedule IV partial mu agonists, buprenorphine is recognized as morphine-like in many drug discrimination studies and produces effects similar to morphine over a wide range of doses. Significant abuse has been documented in many countries although various factors, including the lack of regulatory controls placed on buprenorphine and the scarcity of high purity heroin, have played a role in contributing to this abuse. Buprenorphine's partial agonist effects make buprenorphine less desirable than pure mu agonists in Schedule I or II. The extent to which buprenorphine is able to produce euphoria and “good drug” effects limits its use by opiate tolerant abusers. While buprenorphine can substitute for heroin, it is rarely preferred over high quality heroin. In addition, the reduced respiratory depressant effects of buprenorphine (as a consequence of its “ceiling effect”) imparts greater safety in overdose than other pharmaceutical narcotics controlled in Schedule II.

In reviewing all the data relevant to the abuse potential, including the comments and the DHHS evaluation, the DEA concludes that buprenorphine has an abuse potential less than narcotics in Schedule I or II of the CSA but greater than Schedule IV narcotics.

In addition to having abuse potential, most drugs controlled under the CSA are capable of producing dependence, either physical (physiological) or psychological. Physical dependence refers to the physiological changes produced by repeated use of a drug that necessitates the continued administration of the drug to prevent a withdrawal syndrome. Psychological dependence refers to the need or craving for a drug that compels an abuser to continue drug use.

Chronic buprenorphine administration is associated with physical dependence (for example see: Jasinski et al. , 1978; Kosten et al. , 1988, 1990; San et al. , 1992; Eissenber et al. , 1996). The extent of physical dependence, as measured by an abstinence syndrome, has been characterized as mild to moderate in intensity and of long duration. The profile of withdrawal effects/duration varies with buprenorphine dose, route of administration and duration of chronic use. While some aspects of the abstinence syndrome approach those which occur with pure mu agonists, generally the withdrawal is reported as less intense and may not require pharmaceutical intervention for relief of adverse withdrawal effects.

Jasinski et al. (1978) conducted the original clinical abuse liability studies evaluating buprenorphine's abuse potential. Buprenorphine was shown to produce morphine-like subjective, behavioral and physiological effects and morphine-like physical dependence. The abstinence syndrome observed after abrupt withdrawal of chronically administered buprenorphine (8 mg subcutaneous for 60 days) was delayed producing peak Himmelsbach abstinence scores after about two weeks. Peak withdrawal effects were clinically significant but of lesser magnitude than pure mu agonists. Withdrawal effects included loss of appetite, malaise, insomnia, sensitivity of the skin, lacrimation, rhinorrhea, perspiration, gooseflesh, nausea, leg aches and backaches. These effects were variably reported as mild to moderate and clients requested an opiate to alleviate the symptoms.

In another study examining the physical dependence profile of buprenorphine, 19 heroin dependent male subjects were maintained on 8 mg sublingual buprenorphine for 16 days followed by an additional 18 days of daily or every other day dosing of 8 mg (Fudala et al. , 1990). Abrupt discontinuation in buprenorphine dosing produced an abstinence syndrome starting within the first 72 hours, peaking within 3 to 5 days and diminishing after 8 to 10 days. Over 50 percent of the participants required therapeutic intervention for withdrawal symptoms.

In a report on the use of Subutex® in France (Ministry of Health of France, 1998), clinicians describe a buprenorphine abstinence syndrome similar to abrupt withdrawal from methadone, characterized by 2 to 3 days of no symptoms followed by 10 days of unpleasant symptoms. Abrupt withdrawal of buprenorphine produced effects approaching that of methadone withdrawal but with periods that were very difficult to bear due to the continual switching between a normal state and a state of withdrawal.

One of the clearest indications of buprenorphine physical dependence potential is data gathered on neonates of buprenorphine maintained mothers (Fisher et al. , 2000). Buprenorphine neonatal abstinence syndrome (NAS) was also reported in postmarketing data from France. The withdrawal syndrome, including tremor and autonomic hyperreflexia, is generally mild to moderate in severity. Between 1996 and the first six months of 1999, 66 reports of NAS were reported to the manufacturer.

The extent of psychological dependence produced by buprenorphine is largely dependent on its ability to produce pleasurable effects and the desire or need to continue the use of this drug for those effects. High psychological dependence is associated with significant loss of drug use control, escalation of dose, drug seeking behaviors and maladaptive patterns of substance use despite serious negative consequences. In reviewing the psychological dependence profile of buprenorphine, the DEA considered a number of factors including: drug effects, evidence of diversion, trafficking and abuse of buprenorphine, patterns of drug use and physical or psychological problems associated with continued abuse of this drug.

As reviewed earlier, buprenorphine produces significant morphine-like effects over a wide range of doses and in numerous populations of drug abusers. However, buprenorphine's partial agonist activity often results in shallower dose-response curves with reduced maximal amounts of euphoria, drug liking and/or “good drug” effects than many of the pure mu agonists that have been compared to buprenorphine.

Buprenorphine has been extensively diverted, trafficked and abused throughout many countries although those activities have often been fueled by the lack of high purity heroin and limited regulatory controls placed on buprenorphine (Lavelle et al. , 1991; Rainey, 1986; Strang, 1995, 1991; Tracqui et al. , 1998; Kintz, 2000; Basu, 1998; Robinson et al. , 1993; Dore et al. , 1997, Singh et al. , 1992; Chowdhury et al. , 1998). Surveys in several countries show that buprenorphine, along with heroin, temazepam, and amphetamines, ranks among the top drugs most frequently abused (Lavelle et al. , 1991; Arditti et al. , 1992; Lapeyre-Mestre et al. , 1997; Thirion et al. , 1999; Shewan et al. , 1998; Taylor et al. , 1996; Coggans et al. , 1991; Barnard et al. , 1998). Falsified prescriptions, theft, doctor shopping and street buys have all been identified as sources for buprenorphine.

Buprenorphine use is associated with maladaptive patterns of substance use. In an analysis of 11,186 buprenorphine prescriptions (written in France during 4 months between September through December 1999), 12 percent of the patients received prescriptions from more than two prescribers and 18 percent of the patients were judged as having deviant maintenance treatment with more than two prescribers or more than 20 mg per day of buprenorphine (Thirion et al. , 2002). Data provided in a report generated by a multidisciplinary task force (working under an agreement with the Office of the Junior Minister for Health, the General Health Administration and Schering Plough Laboratories) on the use of Subutex® in France noted that the sales of syringes in France remained stable despite the large numbers of individuals in treatment with Subutex®. At the same time, there was a significant reduction in heroin trafficking and heroin-related deaths. As so many heroin addicts were in treatment and being prescribed medications that are not injectable formulations, the sales for injection equipment should have fallen off drastically. That did not occur. Survey data regarding buprenorphine use indicated that between 12 and 31 percent of buprenorphine users crush the buprenorphine tablets and inject their own medication or diverted medication, often in combination with benzodiazepines (Ministry of Health of France, 1998). Benzodiazepines purportedly enhance and prolong the euphorigenic properties of buprenorphine. These injection practices are associated with the spread of HIV and other communicable diseases as well as serious overdose events. Over 100 deaths in France have been associated high dose buprenorphine injection in combination with benzodiazepines (Tracqui et al. , 1998; Kintz, 2001). In another study of 1018 drug injectors in Glasgow during 1993 and 1994, 41 percent of the injectors reported using buprenorphine and, of those, 26 percent reported at least one overdose (Taylor et al., 1996).

A number of case reports involving buprenorphine abuse demonstrate that buprenorphine is associated with a pathological pattern of use, tolerance development and an opiate abstinence syndrome (Quigley et al. , 1984; Singh et al. , 1992; Basu et al. , 1990). Researchers who have compared the toxicologic and psychopathologic characteristics of buprenorphine dependence with those of heroin found no clinically significant differences (Torrens et al. , 1993).

The availability and use of high-dose sublingual tablets is a relatively new phenomenon. The ease with which addicts can be detoxified after extended use of buprenorphine at high maintenance doses has not been well established nor is there information regarding continued abstinence after detoxification from long-term, high-dose use/abuse of buprenorphine. The dependence capacity of buprenorphine may be heightened under these conditions.

In summary, buprenorphine produces low to moderate physical dependence. The withdrawal syndrome is of less intensity and longer duration than most narcotics in Schedule I or II of the CSA. Therapeutic intervention may be necessary to help ameliorate some of the withdrawal affects. Buprenorphine abuse is associated with a loss of control, escalation of dose, drug seeking behaviors and maladaptive patterns of substance use. The data suggest that buprenorphine has a relatively high psychological dependence profile although it is generally less reinforcing than heroin and other pure mu agonists.

Comment: The buprenorphine/naloxone product (Suboxone®) should be placed in a lower schedule than the single entity product (Subutex®) when/if approved for use in the United States. This differential scheduling would show the lower abuse potential of the combination product and would encourage physicians to preferentially prescribe the combination product.

Answer: The addition of naloxone to the buprenorphine high dose sublingual tablets may be aversive in physically dependent opiate abusers but it will have little (may reduce agonist effects) or no effect in all other populations of abusers. It does not have significantly less abuse potential. For more information, see section on abuse potential.

A physician with the appropriate training in narcotic addiction treatment (as mandated by the Drug Addiction Treatment Act of 2000) has, or will be provided, information about the merits of prescribing the combination product. Should the buprenorphine sublingual tablets be approved for use in the United States, the physician will, ultimately, write a prescription for Subutex® or Suboxone® based on an informed decision about what he/she feels is the best treatment for the patient.

Comment: Because Buprenex® has been in Schedule V and has not been associated with widespread diversion or abuse, there is no compelling reason to reschedule this medication.

Answer: As a single entity product, Buprenex® has no other active ingredient in its formulation that may mitigate its abuse potential. While no significant abuse of Buprenex® has occurred in the United States (which both FDA and DEA believe is directly related to its limited use in the United States) many countries have experienced significant abuse of low dose buprenorphine in tablet and injectable formulations. Buprenex® does not have less abuse potential than other buprenorphine products.

Comment: Products containing less than 1 mg/ml of buprenorphine should be placed in Schedule V of the CSA.

Answer: Because buprenorphine is significantly more potent than morphine with much greater bioavailability by the injection route of administration, intravenous injection of 0.3 mg of buprenorphine (1 dosage unit of Buprenex®) produces physiological and subjective effects equivalent to 10 mg or more of intravenous morphine (Zacny et al. , 1997). Injection of 1 mg/ml buprenorphine would be approximately equivalent to the injection of 20-30 mg of morphine (calculated by extrapolation and considering the shallower dose-response curve). These doses produce significant opiate effects and, if available, are likely to be attractive to most opiate abusers. In addition, as an injectable product, Buprenex® misuse/abuse is associated with possible behavioral risks including shared needles/syringes that contribute to the spread of HIV, hepatitis and other communicable diseases (also review previous comment and answer). There are no provisions in the CSA to schedule narcotic products based solely on the concentration of active ingredient.

Comment: Buprenorphine diversion has been limited to use by out-of-treatment, opioid-dependent, injection drug users.

Answer: While buprenorphine has been primarily abused by injection, data indicates that it has been abused by other routes of administration and other populations of drug abusers. Data from France indicate that a significant percentage of treatment clients (prescribed high dose, single entity product) abuse their own or diverted medication (see discussions on abuse liability and dependence profile).

Comment: Once buprenorphine has been approved for use in opioid substitution treatment, the DEA should study and evaluate abuse over a three-year period in order to more accurately determine whether placement in Schedule III is appropriate.

Answer: Whenever a drug is placed under control in the CSA, the DEA is responsible for monitoring the use of that drug. In addition, the Drug Addiction Treatment Act (DATA) has mandated that DEA monitor the use of Schedule III-V narcotic treatment drugs utilized under DATA.

Comment: The DEA has disregarded data on the development of the naloxone combination product that show significantly less potential for diversion and abuse.

Answer: The DEA is aware that the combination product was specifically developed to deter injection abuse by physically dependent opioid injecting drug abusers. In addition, DEA wants to support and encourage manufacturers to develop products that will reduce the diversion and abuse of legitimate pharmaceuticals. This combination product will inhibit injection by non-buprenorphine dependent addicts and this is a positive outcome. However, after careful examination of all the relevant data regarding the abuse potential of this product in all populations at-risk for abuse (see section on abuse potential), the DEA has concluded that the combination product does not warrant lesser control than other buprenorphine products.

Comment: The DEA has disregarded the additional controls that would be imposed on Subutex® and Suboxone® by the Drug Addiction Treatment Act of 2000 (DATA).

Answer: As part of the review process, both the DEA and the DHHS carefully considered the use of these narcotic treatment drugs within the context of use under DATA. DATA was never intended to be a solitary regulatory piece of legislation and drugs used under this Act must first meet the findings of a Schedule III, IV or V substance as defined in the CSA (21 U.S.C. 812(b)). DATA does not have an impact on the criteria necessary for scheduling under the CSA. The scheduling criteria and procedures remain unchanged and continue to dictate the requirements for the scheduling of buprenorphine as well as any other controlled substance.

Comment: The potential for buprenorphine to be abused, particularly when marketed in high-dose tablets, is consistent with the abuse potential of other Schedule II substances. The partial agonist activity, including safety in overdose, is not supported and, even if true, does not warrant a change from the conclusion that buprenorphine has a high potential for abuse.

Answer: Under certain conditions and in various populations, buprenorphine has a high potential for abuse. Buprenorphine is recognized as morphine-like in many drug discrimination studies and produces effects similar to morphine over a wide range of doses. This data suggests that buprenorphine, if available, would be very attractive to most narcotic abusers ( see section on abuse potential especially in regard to doses of 2 mg or more). However, the extent to which buprenorphine is able to produce euphoria, “good drug” effects, and respiratory depression is limited by its partial agonist properties. That is, almost uniformly, pure mu agonists are capable of producing greater levels of euphoria and other positive subjective effects than buprenorphine. This is an important issue for a drug-tolerant/dependent narcotic abuser (those likely to be prescribed or have access to high-dose buprenorphine tablets). Buprenorphine may alleviate withdrawal, but may not produce the level of “feel-good” effects that the abuser is seeking. Although buprenorphine is abused by heroin addicts, it is rarely preferred over high quality heroin even when buprenorphine is co-administered with benzodiazepines. The low availability and high cost of high purity heroin compared to the high availability and low cost of buprenorphine have been factors in the high incidence of buprenorphine abuse in many countries. Currently, the availability and purity of heroin across the United States is very high while the price of heroin is relatively low in comparison to the projected cost of buprenorphine tablets.

The DEA cited safety in overdose as an example of buprenorphine's partial agonist activity and as a mitigating factor differentiating the abuse potential of buprenorphine from mu agonists in Schedule II of the CSA. Factor (6) under 811(c) requires that the DEA consider what, if any, risk there is to the public health. The commenter argued that this margin of safety exists only when the drug is taken in a carefully controlled clinical setting without concomitant use of other drugs. In fact, narcotic addicts are likely to abuse benzodiazepines with buprenorphine and often by the injection route—all risk factors for buprenorphine-related deaths. The DEA agrees that the increased safety with respect to diminished respiratory depression may be negated under these circumstances. Data from France regarding buprenorphine-related deaths also supports this conclusion. However, for the initiate to opioid abuse or the non-dependent opioid abuser using buprenorphine, the concurrent injection use of buprenorphine with benzodiazepines is less likely to occur. In addition, accidental death or serious overdose by a child or other family member who ingests the medication of an individual prescribed buprenorphine is also less likely to occur. This is an advantage over drugs like morphine, oxycodone and methadone and a relevant factor that carries considerable significance when weighing public health risks and the need for regulatory scrutiny.

In reviewing all the data relevant to the abuse potential, including the evaluation provided by the DHHS as well as all the comments, the DEA concludes that buprenorphine has an abuse potential less than narcotics in Schedule I or II of the CSA but greater than Schedule IV narcotics. It should be noted that a Schedule III substance can have a relatively high abuse potential. The law (21 U.S.C. 812 (b)(3)) does not have an absolute descriptive term ( i.e. high, low) relating to the abuse potential of Schedule III substances. However, the abuse potential must be less than Schedule I or II.

Comment: The DEA failed to consider that the illusion of safety may result in greater potential for abuse.

Answer: Prior to completing the final scheduling review document, the DEA received the FDA review document and a scheduling recommendation from the DHHS. The FDA specifically cited this concern in their document and the DEA considered this possibility. Buprenorphine has often been touted as a drug with minimal abuse potential and great safety in overdose. In many countries, these misconceptions have led to less regulatory oversight and freer prescribing practices by physicians resulting in easier access and greater availability of buprenorphine for abuse purposes. See sections on the abuse potential and dependence profile of buprenorphine. The narcotic abuser may view buprenorphine “safety” as a good reason to select buprenorphine over another narcotic or to use greater amounts of buprenorphine without regard to possible overdose.

Comment: Scheduling under the CSA is a relative analysis and depends on aligning a drug with the closest set of comparators. Buprenorphine most closely resembles Schedule II narcotics.

Answer: Scheduling is a relative analysis. The effects produced by buprenorphine were compared to many Schedule II substances and found, under certain conditions, to be similar. However, buprenorphine is a partial agonist and shares some very important properties with other partial agonists in Schedule IV ( i.e. pentazocine and butorphanol). These partial agonist properties play an important role when comparing buprenorphine effects with pure mu agonist effects. Continued use of all narcotic agonists results in tolerance development, dependence and possible addiction. For the narcotic abuser, escalation of dose, to achieve enhanced effects or to compensate for drug tolerance, will, at some point, be compromised with a partial agonist: the dose-response curve of buprenorphine is more shallow and less linear than mu agonists. This means that buprenorphine may not produce the enhanced effects sought by the chronic drug abuser. In addition, the current data indicates that buprenorphine produces moderate physical dependence and relatively high psychological dependence, not the severe dependence of Schedule II narcotics. Both the DHHS and the DEA have determined that the available data on buprenorphine regarding the abuse potential and dependence profile are most closely aligned to, or defined by, a Schedule III narcotic. For review, please see previous sections on abuse potential and dependence profile found herein.

Comment: Buprenorphine is a gateway drug compounding its public health risks.

Answer: Generally, substances like alcohol, nicotine and marijuana are universally accepted as gateway drugs because data shows that they are often the first drugs used by adolescents and a correlation exists between early experimental use of these substances and an escalation to serious drug abuse problems. One of the at-risk populations for buprenorphine abuse is naïve (inexperienced) opioid abusers ( see section on abuse potential). Early experimentation with buprenorphine may lead to serious drug abuse problems.

Comment: The DEA has not been consistent in its decision making process and has failed to meet the “non-arbitrary agency requirements.” The finding that buprenorphine has a potential for abuse less than Schedule I or II substances is arbitrary and capricious and not supported by underlying administrative record.

Answer: The DEA has not been arbitrary or capricious in the decision making process regarding the abuse potential of buprenorphine. Buprenorphine has a very unique pharmacological profile and produces a range of opioid effects typical of both pure mu agonists and prototypical partial agonists depending on dose, pattern of use, and population taking this drug. Most single entity pure mu agonists are controlled in Schedule I or II of the CSA, while partial agonists, butorphanol and pentazocine, are controlled in Schedule IV. After reviewing all the relevant data, the DEA concluded that buprenorphine's abuse potential is most closely defined by Schedule III ( see section on abuse potential and answers to previous comments).

Comment: One of the strongest signs that a drug has a high potential for abuse is evidence that it is abused through multiple routes of administration, and that it is used with other drugs of abuse. Among other things, this shows that drug abusers not only like the drug, they are trying to enhance its effects. DEA's finding on the abuse potential of buprenorphine failed to consider and give adequate weight to the evidence on this point.

Answer: The DEA did consider various pharmacological parameters relating to the use of buprenorphine by various routes of administration ( see section on abuse potential). Drug abusers frequently abuse more than one drug. The reasons for this are varied. Abusers may be trying to enhance the effects of the drug they are using and/or trying to ameliorate some of the unwanted side effects. The DEA believes appropriate weight was placed on this issue.

Comment: DEA's conclusion that buprenorphine most closely resembles a Schedule III drug, with respect to physical and psychological dependence, is contrary to evidence.

Answer: This comment was followed by a number of citations that were taken from the buprenorphine scheduling review documents of both DEA and FDA (those reviews that were conducted prior to the proposal to place buprenorphine in Schedule III). These comments, for the most part, were taken out of context, interpreted differently or weighted differently than by DEA and/or FDA. For example, the statement that buprenorphine produces “morphine-like physical dependence” does not mean that morphine and buprenorphine have the same physical dependence capacity. It does mean that the physiological changes produced by buprenorphine and morphine are similar and they share similar withdrawal signs. The statement that “under most conditions, buprenorphine's physiological and psychological effects are essentially the same as morphine or hydromorphone” means that buprenorphine is capable of producing effects ( i.e. , miosis, respiratory depression, analgesia, drug euphoria, drug liking and sedation) on a par with morphine and hydromorphone “under most conditions”. A more appropriate caveat would be “under many conditions”. This was a statement taken out of context and does not mean that these drugs produce the same dependence profile. It is important to note that, in making scheduling decisions, all the available information regarding a substance must be synthesized and weighed. The section on dependence profile found herein does not contain all the data DEA relied upon but does provide a summary of some important data and the rationale used by DEA in concluding that buprenorphine produces moderate physical dependence and relatively high psychological dependence.

Comment: In the absence of sufficient data on physical and psychological dependence, the DEA must give weight to its abuse liability assessment.

Answer: While some data was lacking regarding the dependence profile of long-term use/abuse of high dose buprenorphine, sufficient data is available for making a determination regarding buprenorphine dependence ( see previous section on dependence profile). In addition, DEA did not find that buprenorphine has an abuse potential consistent with Schedule II.

Comment: Whether buprenorphine will be eligible for office-based use under recently enacted federal legislation is not a relevant factor in the scheduling analysis and DEA erred by considering it.

Answer: In the March 21, 2002, Federal Register notice on the proposed rule for buprenorphine scheduling, the DEA made the following statement under a section on consequences of this proposed rule: “The DEA recognizes the need to expand narcotic treatment and this factor was a consideration in proposing Schedule III placement for buprenorphine.”

The proposed placement of buprenorphine in Schedule III was not made on the basis of making buprenorphine products available for office-based narcotic treatment. Taken out of context, we recognize that this statement could possibly lead to that interpretation. This statement was meant as a preamble to express DEA's concerns regarding the use of buprenorphine within the context of office-based narcotic treatment. The DEA does recognize the need to expand treatment. As part of our scheduling review, DEA did consider the impact of buprenorphine treatment products used within the context of office-based practice.

The factors for determining the placement of a substance within one of the schedules of controlled substances are specifically laid out in Title 21 U.S.C. 812(b). The manner in which a substance will be used and its availability to the public are among the elements that must be considered in determining a substance's actual or relative potential for abuse ( see section on abuse potential). The DEA did not consider the need to expand narcotic treatment as a specific factor in determining the placement of buprenorphine under the CSA. Certainly the anticipated use of buprenorphine for addiction treatment was a point of consideration in terms of its possible impact on the relative potential for abuse, however, it was not a determining factor.

Comment: To the extent that DEA considered the placement of buprenorphine under Schedule III, in order to expand access to narcotic treatment (67 FR at 13115), DEA was required to do a complete analysis of the impact of its proposal under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Among other things, DEA was required to consider the impact of the decision on small businesses, including methadone treatment programs.

Answer: As stated previously, the DEA did not propose placement of buprenorphine in Schedule III in order to have it available for office based treatment; it was DEA's analysis of the factors laid out in Section 811(c) that resulted in the determination that buprenorphine should be placed in Schedule III.

With respect to the issue of possible economic impact, DEA does not view the placement of buprenorphine into Schedule III as having a direct economic impact on the activities of traditional narcotic treatment programs. As a Schedule III controlled substance, buprenorphine will be equally available to traditional NTP programs as well as office-based treatment providers. The migration of stabilized patients from NTP's to office-based treatment programs will be driven more by the differences in the program requirements and characteristics. The office-based programs may be more attractive to the stabilized patients. As such, DEA stands by its certification that placement of buprenorphine in Schedule III will not have a significant economic impact on a substantial number of small business entities.

Comment: In its concluding statement (of the proposed rule), DEA notes that buprenorphine's abuse potential and dependence profile suggest that there may be significant abuse and diversion of the tablets in the United States. DEA therefore intends to initiate action to increase regulatory control, should that occur. This approach, however, is fundamentally at odds with the approach required under the CSA. The CSA requires DEA to make a reasonable predictive judgment about a drug, and to act proactively to address it. As Congress recognized, the risks associated with drug abuse are too great from a law enforcement and public health perspective to take a reactive posture.

Answer: Sublingual tablets of buprenorphine have not been available in the United States. Both the DEA and FDA relied heavily on foreign experience with these products and no country has marketed a high dose, naloxone-combination product. While drug abuse and addiction are universal problems, the availability of potent narcotic pharmaceuticals and high purity heroin in the United States will likely alter the types of abuse problems experienced with high dose buprenorphine tablets when/if they are approved for marketing. That is, one of the motivators involved in the abuse of buprenorphine in many countries has been the lack of affordable, high purity heroin and fewer, more restrictive controls placed on potent narcotic analgesics. At the same time, narcotic treatment under DATA will be a considerable departure from the more structured Narcotic Treatment Programs of the past decades. Should these products be approved, they will be prescribed by physicians, who may not have extensive experience in dealing with this patient population, and used by addicts, who are likely to abuse/divert their medications. This activity, under DATA, will occur in the absence of enforceable minimal standards of treatment. DEA believes that these conditions increase the likelihood of diversion and abuse of these products.

In light of these uncertainties and in consideration of all the data relevant to buprenorphine's abuse potential and dependence capacity, the DEA has concluded that Schedule III placement and the constraints placed on physicians under the Drug Addiction Treatment Act of 2000 (Pub. L. 106-310) will be sufficient to curb significant abuse problems. However, if our assessment is not correct, the DEA will take appropriate actions.

Comment: The DEA has not presented an adequate basis for the proposed rulemaking. Many of the studies cited by DEA and FDA are not described in sufficient detail. Moreover, some important information from these studies has not been considered by DEA.

Answer: The proposed rule outlines the basic facts. It provides a brief description about the action being proposed, describes buprenorphine as a derivative of thebaine, a partial agonist and its efficacy as an analgesic (with far greater potency than morphine). The two NDAs for buprenorphine products pending at FDA are mentioned with respect to being high-dose sublingual tablets intended for narcotic treatment. The notice outlines an FDA review as part of an NDA process for the proposed treatment drugs. Greater human experience and new scientific data prompted a scheduling review by FDA that resulted in a DHHS rescheduling recommendation. The DEA considered this recommendation and carefully reviewed the FDA scheduling review document (in matters of science and medicine, DHHS findings are binding on DEA). The DEA then conducted a final review and, outlined in the proposed notice, the factors DEA considered in making the decision to propose Schedule III for buprenorphine and all products containing buprenorphine. This was the basis for this proposed rulemaking. Upon request, the DEA did provide the FDA and DEA review documents to interested parties.

In this final rule, the DEA has included summaries of the data DEA relied upon in determining the abuse potential and dependence profile of buprenorphine. However, like most review documents, specific details about all the studies cannot be given. Citations, however, are provided.

This commentator stated that DEA's statements regarding buprenorphine's potency with respect to morphine and the fact that buprenorphine is a derivative of thebaine have no bearing on buprenorphine's abuse potential. As a derivative of thebaine, buprenorphine was originally classified under the CSA as a narcotic. This statement was not made to imply anything with respect to abuse potential. Many substances ( i.e. opiate antagonists) are derived from thebaine and have no abuse potential. Potency, however, is an element that directly affects the abuse potential. As mentioned in an earlier comment, 1 mg/ml of buprenorphine produces substantial euphoria. If buprenorphine is marketed in 2 and 8 mg tablets, those tablets can be dissolved in water and shared by several opiate abusers (depending on level of narcotic tolerance). The implications of this activity speak directly to the abuse potential and the possible public health risks associated with shared injection equipment.

The DEA did review and consider the information in the literature cited, as well as countless other scientific papers, law enforcement and drug abuse data bases, and law enforcement documents that were not cited.

Comment: The proposed rule has not adequately described the pharmacology of the drug substance buprenorphine or the drug products that would be affected by this rule.

Answer: The section herein on abuse potential reviews the pharmacological profile of buprenorphine. Currently, only one buprenorphine product, Buprenex®, will be affected by this rule. This drug product is an injectable formulation containing 0.3 mg/ml of buprenorphine. It is approved for use for moderate to severe pain management.

Two New Drug Applications (NDA) have been submitted to FDA for high dose sublingual tablets. These potential addiction treatment products include: (1) Subutex®, a mono or single entity buprenorphine product, and (2) Suboxone®, a combination product in a 4:1 ratio of buprenorphine to naloxone. The Subutex® and Suboxone® NDAs remain pending at the FDA. When/if these products are approved for marketing they will also be affected by this rule.

Comment: Many facts cited by the DEA and FDA in their conclusions have been removed from their proper scientific context. This is particularly evident in the description of buprenorphine and in the basis for the DEA conclusion that buprenorphine may cause high psychological dependence.

Answer: Concluding statements rarely provide detail and, by their nature, are brief statements regarding conclusions that are made regarding all the available data. The section on buprenorphine's dependence profile herein and previous comments/answers regarding this issue, provide a detailed discussion of the basis for DEA's conclusions regarding dependence potential.

Comment: The DEA and FDA have not explained why data generated since the original scheduling action for buprenorphine in 1985 would alter the original conclusions that buprenorphine has a low potential for abuse and low potential for physical and psychological dependence.

Answer: The DEA has reviewed all the documents pertaining to the original placement of buprenorphine in Schedule V of the CSA. In 1981, buprenorphine hydrochloride (Buprenex®) was approved for use in the United States as an analgesic. In 1982, the Assistant Secretary of Health recommended that buprenorphine be placed in Schedule V of the CSA. This recommendation was based on findings that buprenorphine had an approved medical use in the United States and that its abuse potential and dependence capacity was low and consistent with Schedule V placement. The DEA published a proposal to place buprenorphine in Schedule V in 1982. This rulemaking was finalized on April 1, 1985 (50 FR 8104) following a hearing requested by Reckitt & Colman (now Reckitt Benckiser), the patent holder and manufacturer for buprenorphine worldwide. The company's objection to the proposal was based on their contention that buprenorphine did not have sufficient potential for abuse to warrant Schedule V placement in the CSA and that buprenorphine should not be classified as a narcotic as defined by the CSA. Data was provided from several countries including West Germany, Australia and New Zealand (where buprenorphine had been available for a limited period of time) showing buprenorphine abuse, diversion and trafficking. In addition, FDA provided testimony at the administrative hearing on buprenorphine regarding the basis for their decision to recommend Schedule V.

In reviewing this data, the science, at that time, relied heavily on preclinical studies that indicated that buprenorphine had minimal abuse potential and dependence producing capacity. While Jasinski's (1978) original clinical abuse liability study was available and considered, more weight was placed on the fact that buprenorphine's partial agonist activity mitigated the development of any serious abuse problems and the belief that this was an exceedingly safe drug in overdose. Clinical use in foreign countries, where it had already been approved for marketing, was limited but did indicate that buprenorphine had some abuse potential. However, as a low-dose, injectable formulation for the treatment of moderate to severe pain, widespread use and availability was not anticipated.

Since that time, the use, abuse and available data have increased. Clinical experience with various dosage forms for both pain management and addiction treatment is now available. In addition, the anticipated use of high-dose buprenorphine tablets with the possibility that they could be prescribed by physicians and used in an office based setting for the treatment of opioid addiction prompted FDA to re-evaluate the status of buprenorphine under the CSA. In reviewing all the available data, both FDA and DEA have concluded that placement in Schedule III as a narcotic is the most appropriate schedule for buprenorphine and products containing buprenorphine.

Comment: DEA and FDA rely heavily on data concerning abuse of buprenorphine in foreign countries that occurred prior to the international control of buprenorphine in 1989 under the 1971 Psychotropic Convention.

Answer: Both DEA and FDA reviewed all the available data that addressed the eight factors that are used as a basis for making a final scheduling decision. Published literature regarding the use, misuse, abuse, diversion and trafficking in buprenorphine was gathered and assessed. Published data about the abuse of any drug often provides a wealth of information including: who is abusing it, how it is being abused, source of the drug and possible street prices, extent or seriousness of the abuse, drug effects, concurrent use of other drugs, and reasons it is sought and abused. Much of this information is timeless and speaks to the ability of a drug to produce certain effects that some humans find pleasurable. Both DEA and FDA considered buprenorphine abuse data within the context of regulatory controls, heroin availability and purity, and availability and use of other pharmaceutical narcotics.

Comment: The DEA and FDA have inadequately described the conditions of use of Subutex® in France and the impact of such use on either the mortality associated with heroin addiction or the frequency of abuse of buprenorphine. It is asserted without supporting data that the conditions of use that will apply to Suboxone® and Subutex®, should they be approved for use in the United States, will inevitably lead to significant abuse of buprenorphine. There is no discussion of how the proposed use of Subutex® in the United States may differ from the use of this product in France. There is not an acknowledgment in the proposed rule that one of the products under development, which is not available in France, contains naloxone to deter intravenous abuse.

Answer: Buprenorphine was first marketed in France in 1987 as a low dose sublingual tablet (Arditti et al. , 1992). Between 1992 and 1993, buprenorphine was identified as the third most commonly appearing drug in falsified prescriptions in southwestern France (Baumevielle et al. , 1997). In December 1992, the French government instituted special dispensing and prescribing procedures similar to those governing narcotic drugs: buprenorphine was monitored by the French Medical Association; prescriptions were required to be written on a voucher taken from a counterfoil prescription book that was specifically designed for narcotic drugs; and prescriptions could be filled by any pharmacy, but had to be retained by the pharmacist for three years.

In 1996, general practitioners were permitted to prescribe buprenorphine sublingual tablets (Subutex®, 2 and 8 mg) for treating opiate dependence for up to 28 days per prescription. This system of treatment is a considerable departure from previous policy. Prior to 1996, France provided very limited treatment with methadone in state-run clinics (on a per capita basis, France had the lowest narcotic treatment of any European country). The spread of HIV and other communicable diseases by intravenous drug users and the acceptance of various types of narcotic replacement treatment in other countries (methadone, morphine, heroin and low-dose buprenorphine), combined with data suggesting that high-dose buprenorphine was a safer treatment drug, set the stage for France's new policy. When Subutex® was first launched, the street price of an 8 mg sublingual tablet was 100 francs (Auriacombe et al. , 1997). More recently (Dru, 1999), the street price for buprenorphine in Paris was 10 to 15 francs and was reported as being easily accessible on the illicit market. This reduction in street pricing for buprenorphine is likely the result of widespread availability, by licit and illicit means. Because of continuing reports of abuse and diversion, in September 1999, restrictions on dispensing of buprenorphine were tightened to a 7-day supply per prescription.

Information regarding the use of Subutex® in France comes from a variety of sources. One of the first and most comprehensive reports was generated by a multidisciplinary task force (working under an agreement with the Office of the Junior Minister for Health, the General Health Administration and Schering Plough Laboratories) and reported on the early use of Subutex® in France. Data presented in the report suggested that trafficking in heroin and heroin overdose deaths significantly declined in France since Subutex® became available (an estimated 75 percent reduction). However, data also showed that Subutex® use is associated with significant public health risks. The following points were made by the task force:

• The use of benzodiazepines in combination with buprenorphine products is frequently encountered (both self-reports of addicts and studies have verified the frequency of this combination: about 20 to 44 percent of addicts treated with Subutex® also administer benzodiazepines). From February 1996 to October 1997, health officials were aware of 17 deaths associated with this combination.

• Sales of syringes remained stable despite the large numbers of individuals in treatment with Subutex® (50,000 buprenorphine-treated patients in 1997). Addicts reported that they continue to inject, often crushing, dissolving and injecting their buprenorphine tablets as well as other drugs of abuse.

• Survey data indicated that general practitioners were unable to obtain psychological services for their patients, as few psychiatrists want to treat intravenous drug users (less than 1 percent of the psychiatrists were linked to addiction treatment or had experience in treating addiction).

• Subutex® was diverted and abused by a significant percentage of individuals receiving buprenorphine prescriptions: 12 to 31 percent injected their own medication and 2 to 9 percent received multiple prescriptions from 2 or more physicians.

• Young abusers, not yet addicted to narcotics, were using buprenorphine as a “gateway” drug (the degree to which this occurs was unknown).

Recent data regarding Subutex® use in France is provided by Thirion et al. (2002), who conducted an analysis of 11,186 buprenorphine prescriptions (written between September through December 1999) to determine how buprenorphine was being used by French practitioners. Eighty five percent of the buprenorphine prescriptions were written by general practitioners who often prescribed for only one or two patients. The mean dose was 11.5 mg/day. Twelve percent of the patients received prescriptions from more than two prescribers and 43 percent of the maintained patients had an associated benzodiazepine prescription, often on the same prescription form. Sixty one percent of the patients had regular follow-up, 21 percent had occasional consultations and 18 percent had deviant maintenance treatment (more than two prescribers or more than 20 mg per day of buprenorphine). The authors concluded that the easy access to maintenance treatment in France is associated with a high risk of buprenorphine abuse.

A number of studies have examined buprenorphine-related deaths in France. In a compilation of the case reports and analysis involving buprenorphine overdoses (29 non-fatal and 20 fatal occurring between February 1996 and October 1997 at the hospitals and forensic laboratories in Strasbourg, France), Tracqui and colleagues (1998) speculated that the high dosage of Subutex® tablets is likely to play a role in the occurrence of accidents in spite of the theoretical “ceiling effect.” However, almost all cases involved diverted medication and the use of other psychoactive drugs, especially benzodiazepines. Intravenous injection of the crushed tablet also appears to be a risk factor and was associated with 8 deaths and 10 non-fatal overdoses.

Kintz (2001) reported an additional 117 deaths involving buprenorphine. These fatalities were observed at the Institute of Legal Medicine of Strasbourg from March 1998—July 2000 (39 cases) and at 13 other French forensic centers from mid 1996—March 2000 (78 cases). Eighty two percent of the cases involved males. Needle marks suggesting recent intravenous injection(s) were observed in about half of the subjects. All but one case involved concomitant intake of other psychotropic substances. Benzodiazepines were most commonly found in combination with buprenorphine (91 cases). The author concluded that intravenous injection, concomitant use of CNS depressants (especially benzodiazepines) and high-dose buprenorphine formulation were risk factors in buprenorphine-associated fatalities. He further concluded that the total number of buprenorphine-related deaths in France is probably underestimated due to: (1) The drug is difficult to analyze (low concentration and no readily available immunoassay in France); (2) only some forensic centers responded to the question of fatalities involving buprenorphine; and (3) in numerous cases, an obvious overdose (known drug addict, presence of syringe or packages of Subutex®), no autopsy is requested by the police or a judge.

If approved for use in the United States, the prescription of Subutex® or Suboxone® in an office based setting will be a significant departure from years of regulated narcotic treatment practice. While physicians who want to prescribe these drugs for narcotic treatment must be certified by CSAT and can only treat up to 30 opiate-dependent patients at any given time, other regulatory requirements are less restrictive than those in France.

The above data show a pattern of increased regulatory control measures as a consequence of increasing levels of diversion and abuse. Injection of the Subutex® tablets is a common practice among treatment clients and prescription data indicates that they are also using benzodiazepines. Addiction is a medical disease associated with predictive behaviors that transcend national boundaries. Even in the best treatment programs, recurrent relapse occurs. As stated previously, providing prescriptions of narcotic substances to known drug abusers for the treatment of opiate dependence, in the absence of any enforceable treatment standards, is likely to be related with the diversion and abuse of these medications.

Comment: The additional controls that would be provided by moving buprenorphine to Schedule III are not described and no rationale is provided for the assertion that the Drug Addiction Treatment Act will not provide adequate safeguards for the public health.

Answer: The regulatory controls for those who handle Schedule III narcotics are described later in this final rule. There are some additional regulatory requirements beyond what is required of Schedule V narcotics: prescription refills are limited to 5 refills in 6 months, a permit is required to export this drug, and both manufacturers and distributors must file reports with the DEA. For individuals involved in illicit activities, trafficking penalties and fines are significantly increased.

The Drug Addiction Treatment Act (DATA) does not have an impact on DEA's scheduling responsibilities under the CSA. The scheduling criteria and procedures remain unchanged and continue to dictate the requirements for the scheduling of buprenorphine as well as any other controlled substance.

Comment: The overwhelming scientific and medical evidence demonstrates that buprenorphine should not be rescheduled. If buprenorphine is rescheduled, it should not be placed any higher than Schedule IV.

Answer: Both the DEA and the DHHS have determined that the preponderance of evidence indicates that buprenorphine has an abuse potential and dependence profile consistent with Schedule III of the CSA. The sections on abuse potential and dependence profile and answers to previous comments address this issue.

Relying on the scientific and medical evaluation and scheduling recommendation of the DHHS in accordance with Section 201(b) of the Act (21 U.S.C. 811 (b)), and after a careful consideration of all comments and a final, independent review by the DEA, the Deputy Administrator finds that:

1. Buprenorphine has a potential for abuse less than the drugs or other substances in Schedule I and II.

2. Buprenorphine has a currently accepted medical use in treatment in the United States.

3. Abuse of buprenorphine may lead to moderate or low physical dependence or high psychological dependence

Persons who manufacture, distribute, dispense, import, export, store or engage in research with buprenorphine must comply with the following regulatory requirements:

1. Registration. Any person who manufactures, distributes, dispenses, imports or exports buprenorphine or engages in research or conducts instructional activities or chemical analysis with respect to this substance must be registered to conduct such activities in accordance with 21 CFR part 1301. Those individuals who are currently registered to handle buprenorphine in Schedule V may continue activities under that registration until approved or denied registration in Schedule III provided such registrant has filed an application for registration in Schedule III with DEA on or before November 6, 2002. Any persons not currently registered and proposing to engage in such activities may not conduct activities with the substance until properly registered in Schedule III.

2. Security. Buprenorphine must be manufactured, distributed and stored in accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c) and 1301.76.

3. Labeling and packaging. Products manufactured, distributed or dispensed before October 7, 2002 and labeled as Schedule V may be distributed and dispensed until April 7, 2002. Products manufactured, distributed or dispensed after October 7, 2002 shall comply with the requirement of 21 CFR 1302.03-1302.07.

4. Inventory. Registrants possessing buprenorphine are required to take inventories pursuant to 21 CFR 1304.03, 1304.04 and 1304.11.

5. Records and reports. All registrants must keep records and provide reports pursuant to 21 CFR 1304.03, 1304.04, 1304.21-1304.25 and 1304.33.

6. Prescriptions. All prescriptions for buprenorphine or prescriptions for products containing buprenorphine are to be issued pursuant to 21 CFR 1306.03-1306.07 and 1306.21-1306.26.

7. Importation and Exportation. All importation and exportation of buprenorphine shall be in compliance with 21 CFR part 1312.

8. Criminal Liability. Any activity with buprenorphine not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act or the Narcotic Addict Treatment Act of 2000, shall continue to be unlawful on or after October 7, 2002, except as authorized in this rule.

The Deputy Administrator hereby certifies that this rulemaking has been drafted in a manner consistent with the principles of the Regulatory Flexibility Act (5 U.S.C. 605(b)). It will not have a significant economic impact on a substantial number of small business entities. Buprenorphine is already controlled under the CSA. Individuals who are currently engaged in activities with buprenorphine are already registered to handle controlled substances and are subject to the regulatory requirements of the CSA.

In accordance with the provisions of the CSA (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The Deputy Administrator certifies that this proposed rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). DEA has determined that this is not a significant rulemaking action. Therefore, this action has not been reviewed by the Office of Management and Budget. Buprenorphine is already controlled under the CSA. Individuals who are currently engaged in activities with buprenorphine are already registered to handle controlled substances and are subject to the regulatory requirements of the CSA.

This proposed regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This proposed rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This proposed rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This proposed rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

An electronic copy of this document may be downloaded 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 reach the Office of the Federal Register's home page at: http://www.archives.gov and the Government Printing Office's web page at: http://www.access.gpo.gov/nara.

The Clean Air Act of 1970 (CAA) (44 U.S.C. 7401 et seq. ) requires each State to develop a State Implementation Plan (SIP) that indicates how areas that are not meeting air quality standards intend to meet those standards. The Environmental Protection Agency (EPA) reviews and approves all SIPs. The SIP must specify emission limitations and other measures necessary to attain and maintain the national air quality levels for each pollutant.

In 1977, the Congress amended the CAA to prohibit Federal agencies from engaging in, supporting in any way, or providing financial assistance for any transportation activity that does not conform to the applicable SIP, including Federal or federally assisted transportation projects (Public Law 95-95; 91 Stat. 749). The Congress wanted to ensure that any Federal funding and approval for transportation plans, programs, and projects would be consistent with measures and goals of the SIP. In 1990, the Congress further amended the CAA by integrating it with the transportation planning process and conditioning Federal approval and funding of transportation activities on their demonstrated conformity with the applicable SIP.

The entity responsible for developing transportation plans and programs for urbanized areas of a State is the Metropolitan Planning Organization (MPO). Section 134(g) of title 23, U.S. Code, requires each MPO to prepare and update periodically a long-range transportation plan for its metropolitan area. The MPO must coordinate the development of this long-range plan with the SIP in all metropolitan areas that are nonattainment or maintenance areas for ozone, carbon monoxide, or particulate matter under the CAA (23 U.S.C. 134(g)(3)). These statutory mandates for MPOs have been codified in the FHWA regulations for Metropolitan Transportation Planning and Programming at 23 CFR 450 subpart C. Additionally, the Federal Transit Administration (FTA) adopts these regulations at 49 CFR 613 subpart A where the FTA cross-references and incorporates by reference the FHWA regulations. The FTA concurs with the changes made by this final rule to 23 CFR 450.322(a).

Section 134(g) states that the transportation plan shall be reviewed and updated periodically, according to a schedule that the Secretary of Transportation (hereinafter Secretary) determines to be appropriate. The Secretary, through the Federal Highway Administrator, has outlined the schedule for reviewing and approving the MPO's transportation plans in 23 CFR 450.322(a). The transportation plan has a 20-year horizon and must be reviewed and updated at least triennially in any nonattainment and maintenance areas (23 CFR 450.322(a)).

The New York City metropolitan area includes an urbanized area for the purposes of section 134 and has been designated as a nonattainment area for the purposes of the CAA. The MPO responsible for the New York City metropolitan area is the New York Metropolitan Transportation Council (NYMTC). The NYMTC last reviewed and updated its transportation plan on September 30, 1999, and without this proposed amendment would be required to again review and update the plan by September 30, 2002. Unfortunately, the NYMTC occupied offices in the World Trade Center in Manhattan and their offices were destroyed by the terrorist attacks on the World Trade Center buildings on September 11, 2001. Therefore, it will be impossible for NYMTC to update its transportation plan by September 30, 2002, as required by 23 CFR 450.322(a). This could disrupt Federal highway and transit funding after that date.

In addition to the long-range plan, the MPO must develop a transportation improvement program (TIP) for the area (23 U.S.C. 134(h)(1)(A)). The TIP must be updated every two years and approved by the MPO and the Governor (23 U.S.C. 134(h)(1)(D)). The New York metropolitan area last updated their TIP on November 1, 2001.

Recently, the President signed into law HR 3880 in order to provide NYMTC additional time to review and update its TIP, and prepare conformity determinations, by providing relief from certain transportation conformity and metropolitan transportation planning requirements until September 30, 2005. HR 3880 exempts the New York City area's current TIP and plan from the Clean Air Act's conformity requirements until September 30, 2005. The intent is to provide NYMTC additional time to organize and become operational again in order to work on a new plan and TIP in the aftermath of the September 11, 2001, terrorist attacks on that area.

For the same reasons, the FHWA, in conjunction with the FTA, amends its regulation on Planning and Assistance Standards, which governs the development of transportation plans and programs for urbanized (metropolitan) areas, to provide New York City metropolitan area additional time to review and update its transportation plan. In urbanized nonattainment areas, such as the New York City area, the transportation plan is required to be “revised and updated at least triennially * * *” 23 CFR 450.322(a). The transportation plan for the New York City metropolitan area was last updated on September 30, 1999. The recently enacted HR 3880 that provides NYMTC a temporary waiver from certain statutory and regulatory transportation conformity and metropolitan transportation planning requirements is a clear indication of Congressional intent that the New York city metropolitan area be given relief from the closely related regulatory requirement for updates of the plan, codified in 23 CFR 450.322(a).

Consequently, the FHWA hereby amends the regulation on Planning and Assistance Standards, that governs the development of transportation plans and programs for urbanized (metropolitan) areas and statewide transportation plans and programs, to provide the New York City metropolitan area additional time to review and update its transportation plan. This action waives the regulatory requirement for a triennial plan update for the New York metropolitan area for up to three years, until September 30, 2005, consistent with the date set by the Congress. Since the Congress expressed its intent to provide the NYMTC additional time to review and update its TIP, it is consistent for the FHWA to amend its regulations to support the congressional action to provide relief for NYMTC.

In accordance with section 553(b)(3)(B) of the Administrative Procedure Act, the FHWA believes that good cause exists to waive prior notice and opportunity for public comment as it is impracticable and contrary to the public interest. The Congress has clearly expressed its intent that the NYMTC should be afforded additional time to review and update their plan and TIP by enacting HR 3880. It is unnecessary to provide prior notice and opportunity for public comment for this regulatory change that is consistent with and implements the intent of Congress. Furthermore, prior notice and opportunity for public comment is impracticable because the current plan is set to expire on September 30, 2002, which does not provide sufficient time to obtain public comment on this action. The NYMTC occupied office space in the World Trade Towers that were destroyed in the terrorist attack of September 11, 2001, and it is impossible for the NYMTC to review and update its transportation plan by September 30, 2002. If NYMTC does not have a new plan or a waiver from the requirement to have a new plan on that date, then transportation projects may not advance. Therefore, with the imminent expiration of the current plan and the clear Congressional intent to provide a temporary waiver to the New York City metropolitan area from certain transportation conformity and metropolitan planning requirements, the FHWA believes good cause exists to waive prior notice and opportunity for comment.

For the reasons stated above, the FHWA believes good cause exits to waive prior notice and opportunity for comment. Additionally, in accordance with section 553(d)(3) of the APA, the FHWA believes that good cause exists to make this rule effective upon publication in the Federal Register . Without the relief granted by this action, the New York City metropolitan area would not be able to advance any transportation projects after their current plan expires on September 30, 2002, unless and until the NYMTC is able to review and update their plan or a waiver from this requirement. Since the NYMTC occupied office space in the World Trade Center that was completely destroyed on September 11, 2002, it will be impossible for the NYMTC to create a new transportation plan in that time under the current circumstances. Therefore, it is necessary to amend our regulation to provide the necessary relief contemplated by Congress as soon as possible.

We have determined that this rulemaking is not a significant regulatory action within the meaning of Executive Order 12866 and under Department of Transportation regulatory policies and procedures. This action is intended to reduce current regulatory burdens on the NYMTC for a temporary time period. In preparing this action, the FHWA has sought to maintain existing flexibility of operation wherever possible for States, MPOs, and other affected organizations and utilize already existing processes to accomplish any new tasks or activities.

In compliance with the Regulatory Flexibility Act (Public Law 96-354; 5 U.S.C. 601-612), we have evaluated the effects of this rule on small entities, such as, local governments and businesses. We believe that the flexibility available to States and MPOs in responding to requirements has been maintained, if not enhanced, in this proposal. Accordingly, the FHWA hereby certifies that this action will not have a significant economic impact on a substantial number of small entities.

This action has been reviewed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999, and it has been determined that this action does not have a substantial direct effect or sufficient Federalism implications on States and local governments that would limit the policymaking discretion of the States. Nothing in this document directly preempts any State law or regulation. The Transportation Equity Act for the 21st Century (TEA-21) (Public Law 105-178; 112 Stat. 107) and its predecessors authorize the Secretary to implement the provisions for metropolitan and statewide planning. We believe that policies in these proposed rules are consistent with the principles, criteria and requirements of the Federalism Executive Order and the TEA-21.

Catalog of Federal Domestic Assistance Program Numbers 20.205, Highway planning and Construction; 20.500, Federal Transit Capital Improvement Grants, 20.505, Federal Transit Technical Studies Grants; 20.507, Federal Transit Capital and Operating Assistance Formula Grants. The regulations implementing Executive Order 12372 regarding intergovernmental consultation in Federal programs and activities apply to these programs.

Under the Paperwork Reduction Act of 1995 (PRA)(44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations.

The reporting requirements for statewide transportation plans and programs are approved under OMB control number 2132-0529. The information collection requirements addressed under the current OMB approval number (2132-0529) impose a total burden of 241,850 hours on the planning agencies that must comply with the requirements in the existing regulation.

We have analyzed this action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ). It is our determination this action is consistent with the provisions of 23 CFR 771.117(c)(20) which deems the issuance of regulations of this nature to meet the requirements for a Categorical Exclusion.

This rule does not impose a Federal mandate resulting in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year. (2 U.S.C. 1531 et seq. )

The requirements of 23 U.S.C. 134 and 135 are supported by Federal funds administered by the FHWA and the FTA. There is a legislatively established local matching requirement for these funds of twenty percent of the total project cost. The FHWA and the FTA believe that the costs of complying with these requirements are predominantly covered by the funds they administer.

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

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

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

We have analyzed this final rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a significant energy action under that order because it is not a significant regulatory action under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects under Executive Order 13211 is not required.

The FHWA has analyzed this action under Executive Order 13175, dated November 6, 2000, and believes that this final rule will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal law. Therefore, a tribal summary impact statement is not required.

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of every year. The RINs contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Due to the warnings given by national security and intelligence officials that there is an increased risk that further subversive or terrorist activity may be launched against the United States, the Homeland Security Advisory System level was upgraded to “high” and the Maritime Security (MARSEC) Level was raised to Level II indicating a heightened threat. As a result, a heightened level of security has been established around all passenger vessels in the Portland, Maine, Captain of the Port zone. These security zones are needed to protect passenger vessels, persons aboard passenger vessels, the public, waterways, ports and adjacent facilities from sabotage or other subversive acts, accidents, or other events of a similar nature taken upon passenger vessels in the Portland, Maine, Captain of the Port zone.

Passenger vessels have already begun their seasonal arrivals in the Portland, Maine, Captain of the Port zone. Any delay in the effective date of this rule, is contrary to the public interest insofar as it may render individuals and facilities within, and adjacent to, passenger vessels vulnerable to subversive activity, sabotage or terrorist attack. The measures contemplated by this rule are intended to prevent future terrorist attacks against individuals and facilities within or adjacent to passenger vessels. Immediate action is required to accomplish these objectives and necessary to continue safeguarding these vessels and the surrounding area.

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

On September 11, 2001, terrorists launched attacks on commercial and public structures (airplanes, the World Trade Center in New York and the Pentagon in Arlington, Virginia) killing large numbers of people and damaging properties of national significance. There is an increased risk that further subversive or terrorist activity may be launched against the United States based on warnings given by national security and intelligence officials.

Due to these warnings, on September 10, 2002 the Homeland Security Advisory System level was upgraded to “high” and the Maritime Security (MARSEC) Level was raised to Level II indicating a heightened threat. As a result, a heightened level of security has been established around all passenger vessels in the Portland, Maine, Captain of the Port zone. In addition, the increased tensions in the Middle East have made it prudent for select facilities and vessels to be on a higher state of alert because terrorist organizations have publicly declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.

These heightened security concerns, together with the catastrophic impact that a terrorist attack against a passenger vessel would have to the public interest, make these security zones prudent on the navigable waterways of the United States. Vessels operating near passenger vessels present possible platforms from which individuals may gain unauthorized access to these vessels or launch terrorist attacks upon these vessels. As a result, the Coast Guard is taking measures to prevent vessels or persons from accessing the navigable waters close to passenger vessels in the Portland, Maine, Captain of the Port zone.

This regulation establishes temporary security zones that will be in effect in the navigable waters within a 100-yard radius around any passenger vessel that is moored, or in the process of mooring, at any berth or anchored within the Portland, Maine, Captain of the Port zone. While underway, the security zone will be 100 yards on each side and astern of the passenger vessel and 200 yards ahead which is needed due to the passenger vessel's speed of advance through the water. To clarify which types of passenger vessels this rule applies to, we have adopted a modified version of the definition in 33 CFR 120.100 for this rule by removing the requirement for “making voyages lasting more than 24 hours” and by increasing the requirement for number of passengers from “authorized to carry more than 12 passengers for hire” to “authorized to carry more than 500 passengers for hire”. This change allows for including high capacity cruise ships and international ferries under the definition while excluding smaller vessels.

These security zones are needed to protect passenger vessels, persons aboard passenger vessels, the public, waterways, ports and adjacent facilities from sabotage or other subversive acts, accidents, or other events of a similar nature taken upon passenger vessels in the Portland, Maine, Captain of the Port zone. Entry into these zones will be prohibited unless specifically authorized by the Captain of the Port or his designated representative. Vessels already moored or anchored when these security zones take effect are not required to get underway to avoid either the moving or fixed zones unless specifically ordered to do so by the Captain of the Port or his designated representative.

The Captain of the Port will enforce these zones and may enlist the aid and cooperation of any Federal, state, county, municipal, or private agency to assist in the enforcement of the regulation. To the extent that each is applicable, this regulation is issued under the authority contained in 33 U.S.C. 1226 and 1231; 50 U.S.C. 191; 33 CFR 1.05-1(g), 6.04-1, 6.04-6 and 160.5; and 49 CFR 1.46.

Any violation of the security zones described herein is punishable by, among others, civil penalties (not to exceed $25,000 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment for not more than 10 years and a fine of not more than $250,000), in rem liability against the offending vessel and license sanctions.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). These zones will encompass a small portion of the waterway for a limited period of time. There is ample room for vessels to navigate around the security zones and delays, if any, are expected to be minimal. Vessels and persons may be allowed to enter these zones on a case-by-case basis with permission of the Captain of the Port.

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

For the same reasons stated in the Regulatory Evaluation section above, the Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

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

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

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation because we are establishing a temporary security zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule we are approving with the date that it was amended by the local air agency and submitted by the California Air Resources Board (CARB).

On February 12, 1997, this submittal was found to meet the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review.

We approved into the SIP on August 25, 1994 (59 FR 43751) a version of SCAQMD Rule 1176, originally adopted on November 3, 1989.

Rule 1176 changes for refineries are as follows:

• Refineries will be required to either control with monitoring repeat-emitting drain system components (DSC) to 500 ppm VOC or install controls on all DSCs with less monitoring.

• New process drains are required to have DSC controls.

• Monitoring frequencies are decreased for low-emitting and non-emitting DSCs.

Other Rule 1176 changes for all facilities are as follows:

• Bulk loading terminals are excluded.

• Separator forebays, clarifiers, and tanks are included.

• Schematic identification is required for some facilities for certain components with an accompanying list of all DSCs.

• The 500 ppm VOC limit applies to the entire wastewater system, and no openings are allowed in manhole covers.

• A requirement for the inspector to be certified is added.

• Requirements for recordkeeping and reporting are added.

• Certain exemptions are allowed for sources that would emit little or no VOCs.

Generally, SIP rules must be enforceable (see section 110(a) of the CAA), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), must not interfere with applicable requirements including requirements concerning attainment (see section 110(l)), and must not relax existing requirements in effect prior to enactment of the 1990 CAA amendments (see section 193). The SCAQMD regulates an extreme ozone nonattainment area. 40 CFR 81.305. Therefore Rule 1176 must fulfill RACT requirements.

Guidance and policy documents that we used to define specific enforceability and RACT requirements include the following:

• Requirements for Preparation, Adoption, and Submittal of Implementation Plans, U.S. EPA, 40 CFR part 51.

• Issues Relating to VOC Regulation, Cutpoints, Deficiencies, and Deviations (the “Blue Book”), U.S. EPA, OAQPS (May 25, 1988).

• Control of Refinery Vacuum Producing Systems, Wastewater Separators and Process Unit Turnarounds , EPA-450/2-77-025 (October 1977).

We believe the rule is consistent with the relevant policy and guidance regarding enforceability, SIP relaxations, and fulfilling RACT. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the CAA, EPA is fully approving the submitted rule because we believe it fulfills all relevant requirements. We do not think anyone will object to this approval, so we are finalizing the approval without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rule. If we receive adverse comments by November 6, 2002, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on December 6, 2002. This will incorporate the rule into the federally-enforceable SIP.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Table 2 lists some of the national milestones leading to the submittal of these local agency VOC rules.

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. section 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. section 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 6, 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).

On September 21, 2000, the West Virginia Division of Environmental Protection submitted a revision to its SIP to establish ambient air quality standards for nitrogen dioxide. The revision consists of the adoption of revisions to Regulation 45CSR12—Ambient Air Quality Standards for Nitrogen Dioxide.

This revision restructures and reorganizes Regulation 45CSR12, governing the ambient air quality standards for nitrogen dioxide. The revision also updates reference test methods for measuring nitrogen dioxide concentrations in the ambient air.

The EPA has determined that this revision to 45CSR12—Ambient Air Quality Standards for Nitrogen Dioxide meets all federal criteria for approval.

EPA is approving West Virginia's Rule 45CSR12, submitted as a SIP revision on September 21, 2000, into the West Virginia SIP.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 6, 2002 without further notice unless EPA receives adverse comment by November 6, 2002. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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 Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . 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 6, 2002. Filing a petition for reconsideration by the Administrator of this final rule approving revisions to West Virginia's ambient air quality standards for nitrogen dioxide 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).)

On September 21, 2000, West Virginia submitted a formal revision to its State Implementation Plan (SIP). The SIP revision is a regulation (45CSR5) to prevent and control air pollution from the operation of coal preparation plants, coal handling operations and coal refuse disposal areas in West Virginia.

There are two revisions of 45CSR5 that bring all the of the West Virginia Office of Air Quality coal related rules into one rule. The first revisions of 45CSR5, that set standards for particulate matter weight and visible emissions from coal preparation plants and coal handling operations, went to public hearing on August 12, 1994 and became effective May 1, 1995. The rule also established monitoring, recordkeeping, and reporting requirements and requires that each owner/operator obtain an annual operating permit from the West Virginia Office of Air Quality without which the plant cannot be operated.

The second revisions are to streamline the requirements of 45CSR5 and to incorporate the requirements for coal refuse sites that went to public hearing on July 19, 1999 and became effective August 31, 2000.

(A) Revisions to modify the definitions of the following: (1) Handling operation—to entail similar activities at facilities less than 200 tons of coal per day, (2) coal preparation plants—to conform to the New Source Performance Standards (NSPS) definition in Subpart Y of 40 CFR part 60, and (3) fugitive dust and fugitive dust control system—to clarify that water or chemical suppression are recognized as emission control measures.

(B) Revisions to incorporate the requirements for coal refuse sites: (1) Definitions of coal refuse, coal refuse disposal area, coal refuse pile, and operation of a coal refuse disposal area, (2) standards for coal refuse disposal areas, and (3) burning coal refuse disposal areas.

(C) Revisions to the operating permit requirements to apply only to coal preparation plants. The revised rule provides that coal preparation plants requiring a Title V operating permit would only have to obtain the Title V permit. For owners or operators of a coal preparation plant and for coal handling operations that choose a general permit under 45CSR13, would only be required to submit the required registration and obtain coverage under the general permit.

(D) Revisions to clarify thermal dryers constructed or modified after October 24, 1974 are subject to the NSPS under 40 CFR part 60.

(E) Revisions to clarify that 45CSR17 (fugitive particulate matter emission requirements) is not applicable to 45CSR5 sources.

(F) Revisions correcting Code citations and modifying definitions to conform 45CSR5 to the 1994 statutory changes which incorporated the West Virginia Office of Air Quality into the West Virginia Division of Environmental Protection, Bureau of Environment.

(G) Revisions to clarify that continuous opacity monitoring data may be used to determine opacity violations or compliance not withstanding Method 9 of 40 CFR part 60, Appendix A.

These revisions strengthen the SIP by providing control strategies of coal plants, and are consistent with the NSPS requirements. The structure of the rule is also consistent with the West Virginia organization.

EPA is approving the revisions of 45CSR5, “To Prevent and Control Air Pollution from the Operation of Coal Preparation Plants, Coal Handling Operations and Coal Refuse Disposable Areas,” submitted by West Virginia Division of Environmental Protection on September 21, 2000. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 6, 2002 without further notice unless EPA receives adverse comment by November 6, 2002. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (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 Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . 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 6, 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, to prevent and control air pollution from the operation of coal preparation plants, coal handling operations, and coal refuse disposal areas in West Virginia, may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

On September 21, 2000, the West Virginia Division of Environmental Protection submitted a revision to its SIP to establish reference test methods for measuring ambient air concentrations for carbon monoxide. The revision consists of the adoption of revisions to Rule 45CSR9—Ambient Air Quality Standards for Carbon Monoxide and Ozone.

This revision restructures and reorganizes Regulation 45CSR9, governing the ambient air quality standards for carbon monoxide. The revision also establishes reference test methods for measuring carbon monoxide concentrations in the ambient air. The West Virginia Division of Environmental Protection has reserved sections in Regulation 45CSR9 to address ozone ambient air concentrations and reference test methods. Since the recent ligation of the Federal 8-hour ozone standard, West Virginia will be adopting the 8-hour ozone standard in the future.

The EPA has determined that this revision to 45CSR9—Ambient Air Quality Standards for Carbon Monoxide and Ozone, for the purpose of establishing reference test methods for measuring ambient air concentrations for carbon monoxide meet all Federal criteria for approval.

EPA is approving West Virginia's Rule 45CSR9, submitted as a SIP revision on September 21, 2000, into the West Virginia SIP.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 6, 2002 without further notice unless EPA receives adverse comment by November 6, 2002. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . 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 6, 2002. Filing a petition for reconsideration by the Administrator of this final rule approving revisions to West Virginia's reference test methods for measuring ambient air concentrations for carbon monoxide 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, “we,” “us” and “our” refer to EPA.

On March 31, 2000 (65 FR 17229), EPA proposed to disapprove the following rules that were submitted for inclusion into the California SIP.

We proposed to disapprove these rules because we determined that they did not comply with the relevant CAA requirements. Our proposed action contains more information on the rules and our evaluation.

EPA's proposed action provided a 30-day public comment period. During this period, we received one comment regarding SCAQMD Rule 118, submitted via fax by Barbara Baird of SCAQMD. A signed version of this comment was subsequently submitted dated May 3, 2000, which we are treating as the official comment.

The commenter asserts that EPA must approve Rule 118 because the rule will not interfere with attainment of the National Ambient Air Quality Standards (NAAQS), reasonable further progress (RFP) towards attainment of the NAAQS or any other requirement of the Act. EPA disagrees with this assertion as follows.

1. A state of emergency could potentially last for weeks or even months. During this time (and, in theory, in perpetuity under 118(d)(2)), Rule 118 would allow suspension of any and all requirements for air pollution sources regardless of the effects on human health or the environment. We do not believe that such a broad grant of immunity is in the public interest or is consistent with the CAA. For example, the CAA prohibits SCAQMD and EPA from relaxing SIP requirements or taking actions that would interfere with attainment, RFP, or any other requirements of the Act. 1 Because Rule 118 is written very broadly, it does not ensure compliance with these CAA provisions.

2. The impacts of suspending requirements under Rule 118 could last far beyond the emergency period. For example, an air pollution source could be constructed or modified during a state of emergency without the pollution controls or public review that are normally required. After the emergency period, such a source could continue to emit air pollution at levels that might interfere with attainment, RFP, permit requirements in CAA section 173 or other requirements of the Act, and even at levels directly harmful to human health and the environment. Under Rule 118, however, the source might not be held responsible for those consequences because the permitting rules were suspended when it was constructed or modified. Because such a rule is inconsistent with the CAA and contrary to the public interest, it should not be approved into the SIP.

3. The CAA requires SIPs to contain enforceable emission limits and other control measures. 2 Rule 118 would undermine this requirement by allowing SCAQMD broad discretion to suspend enforceable requirements in the SIP without consultation or approval from EPA or the public.

4. The CAA already allows states to suspend SIP requirements during certain emergencies, but is more focused than Rule 118 and provides for federal oversight. 3 We believe it provides the flexibility needed during an emergency while ensuring adequate protection of public health.

The commenter also states that some emergency situations could justify violation of SIP rules. If such situations occur, EPA believes that enforcement discretion, which can consider various factors such as applicable CAA requirements and impacts on human health and the environment, is a more appropriate mechanism for addressing them than the broad discretion to grant immunity under Rule 118.

No comments were submitted that change our assessment that the submitted rules do not comply with relevant CAA requirements. Therefore, as authorized in section 110(k)(3) of the Act, EPA is disapproving these rules for inclusion into the California SIP. The effect of this action is that the federally enforceable California SIP remains unchanged. The current SIP does not contain any version of AVAPCD and SCAQMD Rule 118, Emergencies.

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

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 E.O. 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 E.O. 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. E.O. 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 E.O. 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 E.O. 13132, because it merely acts on a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. 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.

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.

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.

EPA's disapproval of the state request under section 110 and subchapter I, part D of the Clean Air Act does not affect any existing requirements applicable to small entities. Any pre-existing federal requirements remain in place after this disapproval. Federal disapproval of the state submittal does not affect state enforceability. Moreover, EPA's disapproval of the submittal does not impose any new Federal requirements. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

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 the approval action promulgated 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. This Federal action acts on pre-existing requirements under State or local law, and imposes no new requirements. 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 6, 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, “we,” “us” and “our” refer to EPA.

Throughout this document, “we,” “us” and “our” refer to EPA.

On March 29, 2001 (66 FR 17078), we published a limited approval and limited disapproval of BAAQMD Rule 9-10 as adopted locally on January 5, 1994 and submitted by the State on July 23, 1996. We based our limited disapproval action on certain deficiencies in the submittal. This disapproval action started a sanctions clock for imposition of offset sanctions 18 months after April 30, 2001 and highway sanctions 6 months later, pursuant to section 179 of the Clean Air Act (CAA) and our regulations at 40 CFR 52.31.

On July 17, 2002, BAAQMD adopted revisions to Rule 9-10 that were intended to correct the deficiencies identified in our limited disapproval action. On August 12, 2002, the State submitted these revisions to EPA. In the Proposed Rules section of today's Federal Register , we have proposed approval of this submittal because we believe it corrects the deficiencies identified in our March 29, 2001 disapproval action. In the final rule section of today's Federal Register , we have also published a parallel direct final rule approving the revisions to BAAQMD Rule 9-10. Based on today's proposed approval and parallel direct final approval, we are taking this final rulemaking action, effective on publication, to stay imposition of sanctions that were triggered by our March 29, 2001 limited disapproval.

EPA is providing the public with an opportunity to comment on this stay of sanctions. If comments are submitted that change our assessment described in this final determination and the proposed full approval of the revised BAAQMD Rule 9-10, we will take final action finding that the state has not corrected the original disapproval deficiencies and reimpose sanctions pursuant to 40 CFR 51.31(d). If no comments are submitted that change our assessment, then all sanctions and sanction clocks will be permanently terminated on the effective date of a final rule approval.

We are making an interim final determination to stay CAA section 179 sanctions associated with BAAQMD Rule 9-10 based on our concurrent proposal to approve the State's SIP revision as correcting deficiencies that initiated sanctions.

Because EPA has preliminarily determined that the State has corrected the deficiencies identified in EPA's limited disapproval action, relief from sanctions should be provided as quickly as possible. Therefore, EPA is invoking the good cause exception under the Administrative Procedure Act (APA) in not providing an opportunity for comment before this action takes effect (5 U.S.C. 553(b)(3)). However, by this action EPA is providing the public with a chance to comment on EPA's determination after the effective date, and EPA will consider any comments received in determining whether to reverse such action.

EPA believes that notice-and-comment rulemaking before the effective date of this action is impracticable and contrary to the public interest. EPA has reviewed the State's submittal and, through its proposed action, is indicating that it is more likely than not that the State has corrected the deficiencies that started the sanctions clocks. Therefore, it is not in the public interest to initially impose sanctions or to keep applied sanctions in place when the State has most likely done all it can to correct the deficiencies that triggered the sanctions clocks. Moreover, it would be impracticable to go through notice-and-comment rulemaking on a finding that the State has corrected the deficiencies prior to the rulemaking approving the State's submittal. Therefore, EPA believes that it is necessary to use the interim final rulemaking process to stay sanctions while EPA completes its rulemaking process on the approvability of the State's submittal. Moreover, with respect to the effective date of this action, EPA is invoking the good cause exception to the 30-day notice requirement of the APA because the purpose of this notice is to relieve a restriction (5 U.S.C. 553(d)(1)).

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 stays federal sanctions and imposes no additional requirements. Accordingly, the administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule only stays sanctions, and does not impose any additional enforceable duty, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This 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.

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 requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply to this rule because it imposes no standards.

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. However, section 808 provides that any rule for which the issuing agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rule) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the agency promulgating the rule determines. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefor, and established an effective date of October 7, 2002. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 7, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purpose of judicial review nor does it extend the time within which 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).)

On October 30, 1998, the Pennsylvania Department of Environmental Protection (PADEP), submitted on behalf of Allegheny County Health Department (ACHD) a formal revision to the State Implementation Plan (SIP) for the control of VOC and NO X emissions from major sources. This revision included amendments to the definitions of the terms major source, potential emissions, and low NO X burner with separate overair. This revision consists of new reasonably available control technology (RACT) regulations which would require sources that emit or have the potential to emit 50 tons per year (tpy) or more of VOC or 100 tpy or more of NO X in Allegheny County to comply with RACT requirements by May 31, 1995.

Pursuant to sections 182(b)(2) and 182(f) of the Clean Air Act (CAA), major sources of VOC & NO X located in Allegheny County were required to implement RACT by no later than May 31, 1995. The major source size is determined by its location, the classification of that area and whether it is located in the ozone transport region (OTR). At the time of the SIP revision submittal, Allegheny County was classified as a moderate ozone nonattainment area. On October 19, 2001 (66 FR 53094), the Pittsburgh-Beaver Valley Ozone Area, which includes Allegheny County, was redesignated to attainment. The SIP submittal which is the subject of this rulemaking consists of Allegheny County's; Article XXI; Section 2105.06—Major Sources of NO X and VOC Compounds and revisions to Section 2101.20 which amends definitions of the terms Major Source, Potential Emissions and Low NO X Burner with Separate Overfire Air.

Allegheny County's Article XXI, Section 2105.06 requires major sources of VOCs and NO X for which no applicable emission limitations have been established, to identify their emissions, propose RACT, and to complete implementation of RACT by May 31, 1995. Subsequently, PADEP will submit for ACHD each source-specific RACT determination to EPA for approval as a SIP revision.

Section 2105.06(d) provides certain major NO X sources with an alternative to case-by-case RACT determinations. This section specifies that presumptive RACT for coal-fired combustion units with a rated heat input equal to or greater than 100 million British Thermal Units per hour (mmBTU/hr) is the installation of low NO X burners with separate overfired air. For units with a rated heat input between 20 mmBTUs/hr and 50 mmBTUs/hr presumptive RACT is an annual adjustment or tune-up of the combustion process to include at a minimum; Inspection, adjustment, cleaning, or replacement of fuel-burning equipment, including the burners and moving parts necessary for proper operation as specified by the manufacturer; inspection of the flame pattern or characteristics and adjustments necessary to minimize total emissions of NO X , and to the extent practicable minimize emissions of CO; and inspection of the air-to-fuel ration control system and adjustments necessary to ensure proper calibration and operation as specified by the manufacturer. For all combustion units with a rated heat input equal to or greater than 20 mmBTU/hr and less than 50 mmBTU/hr, presumptive RACT is to record each adjustment in a permanently bound log book, or other methods approved by ACHD, which contains, at a minimum: The date of the adjustment procedure, the name of the service company and technicians, the operating rate or load after adjustment, the CO and NO X emission rates after adjustment, the excess oxygen rate after adjustment, and other information required by the applicable operating permit.

For the following source types, presumptive RACT is the installation, maintenance, and operation of the source in accordance with manufacturer's specifications: (1) Boilers and other combustion sources with individual rated gross heat inputs less than 20mmBTUs/hr of operation; (2) combustion turbines with individual heat input rates less than 25mmBTU/hr which are used for natural gas distribution; (3) internal combustion engines rated at less than 50 brake horsepower (bhp) gross which are set and maintaining 4 degree retarded timing relative to standard timing; (4) incinerators or thermal/catalytic oxidizers used primarily for air pollution control; (5) any fuel-burning equipment, gas turbine, or internal combustion engine with an annual capacity factor of less than 5 percent, or an emergency standby engine operating less than 500 hours in a consecutive 12-month period; (6) sources which have been approved as meeting the Lowest Available Emission Rate (LAER) for NO X emissions since November 15, 1990, with federally enforceable emission limitations; and (7) sources which have been approved as meeting the Best Available Control Technology (BACT) for NO X emissions since November 15, 1990, with federally enforceable emissions limitations, also these sources must still meet any applicable, more stringent category-wide RACT requirements.

Section 2105.06(e) permits major NO X sources to submit a RACT proposal that includes averaging of emissions at two or more facilities provided several conditions are met and the proposal is approved by EPA as a revision to the Pennsylvania SIP for Allegheny County. Among other conditions, the averaging scheme must require emission caps and enforceable emission rates at each participating source, telemetry links between the participating sources, and an up-front agreement that a violation at one of the participating sources is considered a violations at all of the participating sources.

Section 2105.06(f) provides that RACT for VOC sources is the installation, maintenance, and operation of the source in accordance with the manufacturer's specifications. VOC sources that have been approved as meeting BACT and/or LAER since November 15, 1990, must also meet more stringent category-wide RACT emission limitations.

The recordkeeping provisions apply to all VOC and NO X sources in Allegheny County. This section clearly requires that records be kept for a period of at least 2 years and that such records must provide sufficient data and calculations to demonstrate compliance with the applicable RACT requirements. This section also requires that sources of VOC and NO X that claim exemptions from RACT maintain records that clearly demonstrate their exempt status.

1. Major Source —The October 30, 1996 submittal amends the definitions of the terms Major Source, Potential Emissions and Low NO X Burner with Separate Overfire Air found in Section 2101.20. Allegheny County defines the term Major Source as any stationary source, or any group of stationary sources, that is located on one or more contiguous or adjacent properties, is under common control of the same person (or persons under common control), belongs to a single major industrial grouping, and is described as follows: For ozone nonattainment areas, sources with the potential to emit 100 tpy or more of VOC or NO X in areas classified as “marginal” or “moderate,” 50 tpy or more in areas classified as “serious,” 25 tpy or more in areas classified as “severe,” and ten (10) tpy or more in areas classified as “extreme”; except that the references in this paragraph to 100, 50, 25, and ten (10) tpy of nitrogen oxides shall not apply with respect to any source of which the Administrator has made a finding, under Section 182 (f)(1) or (2) of the Clean Air Act, that requirements under Subsection 182(f) of the Act do not apply; for ozone transport regions established pursuant to Section 184 of the Clean Air Act, sources with the potential to emit 50 tpy or more of VOCs. The definition of a major source conforms to EPA's definition. For the purposes of defining “major source,” a stationary source or group of stationary sources shall be considered part of a single industrial grouping if all of the pollutant emitting activities at such source or group of sources on contiguous or adjacent properties belong to the same Major Group ( i.e. , all have the same two-digit code) as described in the most recent Standard Industrial Classification Manual.

2. Potential Emissions —Allegheny County defines the term Potential Emissions as the maximum capability of a source to emit air contaminants, including fugitive emissions, under the physical and operational design of the source. Any physical or operational limitation on the capability to emit air contaminants, including air pollution control equipment and techniques and permit conditions limiting the operating rate, hours of operation, or fuels or raw materials used, shall be treated as part of the design of the source to the extent such limitation, or its effect on emissions, is federally enforceable under the provisions of the Clean Air Act.

3. Low NO X Burner with Separate Overfire Air —Allegheny County defines this term as a burner design capable of reducing the formation of oxides of nitrogen (NO X ) emissions through substoichiometric combustion of fuel by means of a burner assembly consisting of two or more stages and the addition of secondary combustion air introduced downstream of the burner location.

On October 16, 2001 (66 FR 52506), EPA fully approved the Commonwealth of Pennsylvania's Generic VOC and NO X RACT regulations as they apply in the Pittsburgh-Beaver Valley Ozone area, including Allegheny County. All of the source specific RACT determinations for major sources of NO X and VOC located in Allegheny County have already been issued by ACHD, submitted to EPA by PADEP, and approved by EPA as SIP revisions. In accordance with the EPA policy memorandum for “Approval Options for Generic RACT Rules Submitted to Meet the non-CTG VOC RACT Requirement and Certain NO X RACT Requirements” dated November 7, 1996, Allegheny County's generic RACT regulation is fully approvable because all of the source-specific RACT determinations have already been submitted and approved as SIP revisions, and there are no remaining unregulated sources. EPA has also determined that Allegheny County's regulation is consistent with Pennsylvania's generic VOC and NO X RACT regulations which were fully approved for the Pittsburgh-Beaver Valley Ozone area, including Allegheny County, on October 16, 2001 (66 FR 52506).

EPA is granting full approval of Allegheny County's Generic VOC and NO X RACT regulations, Article XXI, Section 2105.06—Major Sources of NO X and VOC Compounds and revisions to Section 2101.20—Definitions for the terms Major Source, Potential Emissions and Low NO X Burner with Separate Overfire Air, as revisions to the Pennsylvania SIP.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on November 21, 2002 without further notice unless EPA receives adverse comment by November 6, 2002. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (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 Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . 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 6, 2002. Filing a petition for reconsideration by the Administrator of this final rule to approve and revise certain definitions ofAllegheny County's Generic VOC and NO X RACT regulations do 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, “we,” “our,” or “us” refers to the United States Environmental Protection Agency.

The conformity rules assure that in air quality nonattainment or maintenance areas projected emissions stay within the emissions ceiling in the SIP. The rules for conformity of general Federal actions assure that actions of Federal agencies that take place in nonattainment or maintenance areas, other than transportation actions, are consistent with the Montana SIP. Conformity first appeared in the Act's 1977 amendments (Pub. L. 95-95). Although the Act did not define conformity, it stated that no Federal department could engage in, support in any way or provide financial assistance for, license or permit, or approve any activity which did not conform to a SIP which has been approved or promulgated.

The Act's 1990 Amendments expanded the scope and content of the conformity concept by defining conformity to an implementation plan. Section 176(c) of the Act defines conformity as conformity to an implementation plan's purpose of eliminating or reducing the severity and number of violations of the national ambient air quality standards (NAAQS) and achieving expeditious attainment of such standards. Also, the Act states that no Federal activity will: (1) Cause or contribute to any new violation of any standard in any area, (2) increase the frequency or severity of any existing violation of any standard in any area, or (3) delay timely attainment of any standard or any required interim emission reductions or other milestones in any area.

All Federal government agencies must follow The General Conformity rules. The General Conformity rules establish emissions thresholds for requiring a conformity analysis. The Federal agency taking the action is required to perform the conformity analysis. We published the first General Conformity rule on November 30, 1993 (58 FR 63214) and it was codified at 40 CFR part 93, subpart B.

Section 176(c)(A) of the Act requires us to issue criteria and procedures for determining conformity of all Federal actions to applicable SIPs. 40 CFR part 93, subpart A spells out criteria and procedures for determining conformity of all Federal actions related to transportation projects funded or approved under Title 23 U.S.C. or the Federal Transit Laws (49 U.S.C. Chapter 53). 40 CFR part 93, subpart B provides criteria and procedures for determining the conformity of all other Federal actions to applicable SIPs. Examples of Federal actions covered by this rule may include but are not limited to reuse of military bases, private construction on Federal land, granting of permits, leasing of Federal land, and construction of Federal office buildings.

The Act requires each State to develop rules to implement the General Conformity rule. ( See 40 CFR 93.151) EPA believes that State and local agencies have the primary responsibility for achieving the clean air goals established in the Act. Therefore, each State must submit a revised SIP that includes General Conformity criteria and procedures that are consistent with General Conformity rule. These criteria require that State rules must be at least as stringent as the requirements specified in EPA's General Conformity rule. Furthermore, State rules can only be more stringent if they apply equally to Federal and non-Federal entities.

Section 110(k) of the Act addresses our actions on submissions of revisions to a SIP. The Act requires States to observe certain procedural requirements in developing SIP revisions for submission to us. Section 110(a)(2) of the Act requires that each SIP revision be adopted after reasonable notice and public hearing. This must occur prior to the revision being submitted by a State to us.

On August 26, 1999, the Governor of Montana submitted a SIP revision that adopts Administrative Rules of Montana (ARM), Sub-Chapter 14, “Conformity of General Federal Actions,” Sections 17.8.1401 and 17.8.1402. The Montana Board of Environmental Review adopted this SIP revision at a public hearing on May 14, 1999 after appropriate public participation and interagency consultation and it became effective in the ARM as State law on June 4, 1999.

We have evaluated the Governor's submittal and have determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the Act. By operation of law under section 110(k)(1)(B) of the Act, the Governor's August 26, 1999, submittal became complete on February 26, 2000.

We are approving the Administrative Rules of Montana (ARM), Sub-Chapter 14, “Conformity of General Federal Actions,” Sections 17.8.1401 and 17.8.1402 submitted by the Governor of Montana on August 26, 1999. The Montana Board of Environmental Review adopted this SIP revision at a public hearing on May 14, 1999 after appropriate public participation and interagency consultation and it became effective in the ARM as State law on June 4, 1999. The Montana rules are consistent with the Federal General Conformity rules.

Montana incorporated 40 CFR part 93, subpart B into the State rules. Montana modified definitions found in 40 CFR part 93, subpart B and incorporated them into the State rule. The definitions of “MPO” (Metropolitan Planning Organization) and “state air quality agency” were modified to incorporate meaning specific to Montana. Montana incorporated 40 CFR 93.153 and 93.160 with modifications to provide language consistent with a State rule rather than a Federal rule. We agree with these minor changes. It should be noted that Administrative Rules of Montana (ARM) Section 17.8.1402, a subject of this action, references ARM Section 17.8.1302 which we did not act on in a previous Federal Register action (66 FR 48561, September 21, 2001). ARM 17.8.1302 includes an incorporation by reference (IBR) of 40 CFR part 93, subpart A. EPA excluded ARM Section 17.8.1302 because of the IBR. The rationale for not acting on ARM 17.8.1302 is discussed in a separate action (66 FR 48561, September 21, 2001).

In this action, we are approving the adoption of ARM, Sub-Chapter 14, “Conformity of General Federal Actions,” Sections 17.8.1401 and 17.8.1402 to the Montana SIP. This SIP revision was submitted by the Governor of Montana on August 26, 1999. We are publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the “Proposed Rules” section of today's Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 6, 2002, without further notice unless we receive adverse comments by November 6, 2002. If we receive adverse comments, we will publish a timely withdrawal of the direct final rule, in the Federal Register , informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. If no such comments are received, the public is advised that this rule will be effective on December 6, 2002, and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Section 110(l) of the Act states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable progress towards attainment of a National Ambient Air Quality Standard (NAAQS) or any other applicable requirements of the Act. This SIP revision is consistent with Federal requirements and does not interfere with any applicable requirements of the Act. Therefore, we conclude that our approval of ARM, Sub-Chapter 14, “Conformity of General Federal Actions,” Sections 17.8.1401 and 17.8.1402 meets the intent of section 110(l) of the Act.

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 6, 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).)

Chapter I, title 40, part 52, of the Code of Federal Regulations is amended to read as follows:

Throughout this document wherever “we,” “us,” or “our” are used we mean EPA.

The Act requires States to follow certain procedures in developing implementation plans and plan revisions for submission to EPA. Sections 110(a)(2) and 110(l) of the Act provide that each implementation plan a State submits must be adopted after reasonable notice and public hearing.

We also must determine whether a submittal is complete and therefore warrants further review and action [ see section 110(k)(1) of the Act and 57 FR 13565]. EPA's completeness criteria for SIP submittals can be found in 40 CFR part 51, appendix V. EPA attempts to determine completeness within 60 days of receiving a submission. However, the law considers a submittal complete if we don't determine completeness within six months after we receive it.

To provide for public comment, the North Dakota Department of Health (NDDH), after providing adequate notice, held a public hearing on September 28, 2000 to address the revisions to the SIP and Air Pollution Control Rules. Following the public hearing, public comment period, and legal review by the North Dakota Attorney General's Office, the North Dakota State Health Council adopted the rule revisions, which became effective on June 1, 2001.

The Governor of North Dakota submitted the SIP revisions to EPA with a letter dated June 21, 2001. We reviewed them to determine completeness under the completeness criteria in 40 CFR part 51, appendix V. We found the submittal complete and so notified the Governor in a letter dated July 26, 2001. That letter also described the next steps to be taken in our review.

As noted above, we will handle separately the revisions in the June 21, 2001 submittal regarding Chapter 33-15-21 (the State's Acid Rain Program) and a direct delegation request for North Dakota Air Pollution Control Rules Chapter 33-15-22, regarding emission standards for hazardous air pollutants for source categories. The submittal also included a direct delegation request for standards of performance for new stationary sources (see below). The revisions in the June 21, 2001 submittal to be addressed in this document pertain to general provisions, emissions of particulate matter and fugitives, exclusions from Title V permit to operate requirements, and prevention of significant deterioration, which involve the following chapters of the North Dakota Administrative Code (N.D.A.C.): 33-15-01 General Provisions; 33-15-05 Emissions of Particulate Matter Restricted; 33-15-14 Designated Air Contaminant Sources, Permit to Construct, Minor Source Permit to Operate, Title V Permit to Operate (subsection specific to exclusions from Title V permit to operate requirements only); 33-15-15 Prevention of Significant Deterioration; and 33-15-17 Restriction of Fugitive Emissions.

The definition for “public nuisance” was removed from this chapter because the State believes it is covered under the definition of “air pollution.” In addition changes were made to clarify reporting requirements when stack testing for air contaminant emissions. The requirements are consistent with 40 CFR parts 60, 61, 63, and 75. Because these revisions are consistent with Federal requirements, they are approvable.

In Section 33-15-05-04, Methods of Measurement, the State deleted the F factors for various fuels and replaced them with a reference to 40 CFR part 60, Appendix A, Method 19. This revision simply incorporated reference information from Federal rules and is approvable.

Subsection 33-15-14-07 was added to provide an exemption from the Title V permitting requirements for certain gasoline service stations, bulk gasoline plants, coating sources, printing, publishing and packaging operations, degreasers using volatile organic solvents, and hot mix asphalt plants. The sources that qualify for this exemption will be required to maintain certain records which demonstrate that they are minor sources and in some instances, report to the State.

This exclusionary rule creates generic potential-to-emit (PTE) limits for specific source categories, and thereby clarifies which of the sources within the specific categories are minor with respect to the Title V operating permit requirements. The rule is only intended to exclude certain sources from the requirements of Title V, but not from North Dakota's construction or minor source operating permit programs. EPA's authority for approval of exclusionary rules, generally, is Section 110 of the Clean Air Act, which allows us to approve preconstruction permit programs and rules and non-title V operating permit programs and rules. Therefore, we are approving this new exclusionary subsection, 33-15-14-07, as part of the federally-approved SIP.

The definition of “significant” was updated to match the Federal definition. In addition, a provision was removed that did not allow a PSD source to consume more than one-half of the available increment in another state unless approved by the North Dakota Health Department after consultation with the other state. The removal of this provision was made to make the State rules more consistent with Federal requirements (40 CFR 51.166 and 40 CFR 52.21 do not include this requirement). Although there is no longer a consultation requirement, there are still requirements under ND's PSD program for notice to an affected state and an affected Federal Land Manager of any source which may significantly impact their land. This notification usually takes the form of a copy of the public notice, a copy of the related analyses, and a copy of the draft permit. The affected parties then have the opportunity during the public comment period to provide comments to the NDDH. Since the revisions to this chapter are consistent with Federal requirements, they are approvable.

The revisions to this chapter involved deleting a reference to nuisances and replacing it with a requirement that a source cannot cause air pollution as defined in the general provisions chapter (to be consistent with the changes made to Chapter 33-15-01, discussed above). These revisions are approvable because the State believes that nuisances are covered under its definition of “air pollution.”

With the June 21, 2001 submittal, North Dakota requested delegation of authority for revisions to the New Source Performance Standards (NSPS), promulgated in Chapter 33-15-12, N.D.A.C. On January 3, 2002 delegation was given with the following letter:

EPA is providing notice that with the July 7, 1995 interim approval of North Dakota's Title V Operating Permit program (see 60 FR 35335), it granted delegation of authority to North Dakota to implement and enforce Clean Air Act section 112 requirements. This delegation of authority includes, among other things, the NESHAPs promulgated in 40 CFR part 61 (“part 61 NESHAPs”). The State's part 61 NESHAPs regulations are contained in Chapter 33-15-13, N.D.A.C.

With a September 10, 1997 submittal, the State revised Chapter 33-15-13 to incorporate all Federal part 61 NESHAPs (except 40 CFR part 61, subparts B, H, K, Q, R, T, and W, pertaining to radionuclides) promulgated as of October 1, 1996. However, the State's NESHAPs authorities do not include those authorities which cannot be delegated to the states, as defined in 40 CFR part 61.

In addition, EPA cannot act on the State's request for delegation of authority for 40 CFR part 61, subpart I (regarding radionuclide emissions from facilities licensed by the Nuclear Regulatory Commission and other Federal facilities not covered by subpart H) because EPA rescinded subpart I (see 61 FR 68972-68981, December 30, 1996) subsequent to the State's adoption of these revisions.

Given that the State has had delegation of authority for part 61 NESHAPs for many years, EPA is removing “Emission Standards for Hazardous Air Pollutants, Chapter 33-15-13 , N.D.A.C., from the federally-approved SIP.

Section 110(l) of the Clean Air Act states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress towards attainment of the NAAQS or any other applicable requirements of the Act. The North Dakota SIP revisions that are the subject of this document do not interfere with the maintenance of the NAAQS or any other applicable requirements of the Act. The SIP revision amends the State's General Provisions and Methods of Measurement and these changes are consistent with Federal requirements and rules. The new rules that provide for source exclusions from the title V permit to operate requirements are consistent with EPA's authority to approve exclusionary rules under section 110 of the Clean Air Act and the rules do not interfere with the maintenance of the NAAQS or any other applicable requirements of the Act because they are consistent with the April 14, 1998, EPA guidance from John Seitz, Director of the Office of Air Quality Planning and Standards, entitled “Potential to Emit (PTE) Guidance for Specific Source Categories.” The update to the State's PSD rules mirror the Federal rules. Finally, the State's removal of the term “nuisance” does not interfere with the maintenance of the NAAQS or any other applicable requirements of the Act since nuisances can still be addressed under the State's definition of “air pollution.”

EPA is approving North Dakota's SIP revision, as submitted by the Governor with a letter dated June 21, 2001. The revisions in the June 21, 2001 submittal which are being approved in this document involve the following chapters of the North Dakota Administrative Code: 33-15-01 General Provisions; 33-15-05 Emissions of Particulate Matter Restricted; 33-15-14 Designated Air Contaminant Sources, Permit to Construct, Minor Source Permit to Operate, Title V Permit to Operate (specifically, subsection 33-15-14-07, Source Exclusions from Title V Permit to Operate Requirements); 33-15-15 Prevention of Significant Deterioration; and 33-15-17 Restriction of Fugitive Emissions. The June 21, 2001 submittal also included requests for direct delegation of Chapter 33-15-21, Acid Rain Program and Chapter 33-15-22, Emission Standards for Hazardous Air Pollutants for Source Categories, which are being handled separately.

In addition, as requested by the State with its June 21, 2001 submittal, EPA is providing notice that it granted delegation of authority to North Dakota on January 3, 2002, to implement and enforce the NSPS promulgated in 40 CFR part 60, promulgated as of August 1, 2001 (except subpart Eb, which the State has not adopted). However, the State's NSPS authorities do not include those authorities which cannot be delegated to the states, as defined in 40 CFR part 60.

Finally, EPA is providing notice that with the July 7, 1995 interim approval of North Dakota's Title V Operating Permit program ( see 60 FR 35335), it granted delegation of authority to North Dakota to implement and enforce Clean Air Act section 112 requirements. This delegation of authority includes, among other things, the NESHAPs promulgated in 40 CFR part 61 (“part 61 NESHAPs”). The State's part 61 NESHAPs regulations are contained in Chapter 33-15-13 of the North Dakota Administrative Code. With a September 10, 1997 submittal, the State revised Chapter 33-15-13 to incorporate all Federal part 61 NESHAPs (except 40 CFR part 61, subparts B, H, K, Q, R, T, and W, pertaining to radionuclides) promulgated as of October 1, 1996. However, the State's NESHAPs authorities do not include those authorities which cannot be delegated to the states, as defined in 40 CFR part 61. Given that the State has had delegation of authority for part 61 NESHAPs for many years, EPA is removing Emission Standards for Hazardous Air Pollutants, Chapter 33-15-13 of the North Dakota Administrative Code, from the federally-approved SIP.

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 6, 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).)

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-142, adopted September 16, 2002, and released September 23, 2002. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW, CY-B402, Washington, DC, 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-132, adopted September 23, 2002, and released September 27, 2002. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW, CY-B402, Washington, DC, 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-153, adopted September 23, 2002, and released September 27, 2002. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC, 20554. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 202-863-2893, facsimile 202-863-2898, or via-e-mail qualexint@aol.com.

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-152, adopted September 23, 2002, and released September 27, 2002. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC, 20554. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 202-863-2893, facsimile 202-863-2898, or via-e-mail qualexint@aol.com.

Electronic Access: This rule is accessible via the Internet at the Office of the Federal Register's Web site at http:// www.access.gpo.gov/su_docs/aces/aces140.html . Background information and documents are available at the NMFS Northwest Region Web site at http://www/nwr.noaa.gov/1sustfsh/gdfsh01.htm and at the Council's Web site at http://www.pcouncil.org.

On April 15, 2002, NMFS published an emergency rule (67 FR 18117) establishing a whiting acceptable biological catch (ABC) based on F40% F proxy with a medium recruitment scenario. The U.S.-Canada coastwide ABC was set at 208,000 mt, with a U.S. ABC of 166,000 mt. That emergency rule also adopted a U.S.-Canada coastwide optimum yield (OY) of 162,000 mt and a U.S. OY of 129,600 mt.

Each year, the whiting OY is allocated between the tribal and commercial sectors of the fishery. The Pacific Coast Indian treaty fishing rights, described at 50 CFR 660.324, allow for the allocation of fish to the tribes through the annual specification and management process. Regulations at 50 CFR 660.323(a)(4) divide the commercial OY into separate allocations for the non-tribal catcher/processor, mothership, and shore-based sectors of the whiting fishery.

For 2002, NMFS set the tribal whiting allocation at 22,680 mt. The non-tribal commercial OY for whiting is 106,920 mt (the 129,600 mt OY minus the 22,680 mt tribal allocation). Each non-tribal sector receives a portion of the commercial OY, with the catcher/processors getting 34 percent (36,353 mt), motherships getting 24 percent (25,661 mt), and the shore-based sector getting 42 percent (44,906 mt).

Additional information concerning the 2002 whiting ABC and OY and sector allocations of whiting may be found in the April 15, 2002 (67 FR 18117), Federal Register document for this action. Extension of this emergency rule is authorized under section 305(c)(3)(B) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

During the comment period, NMFS received 1 letter from an association representing seafood processors and associated businesses that process, transport and sell whiting products. The comments resulted in no change to the emergency rule.

Comment 1: We request that the emergency rule be withdrawn and re-issued to establish whiting harvest levels as recommended by the Pacific Fishery Management Council.

Response: The Council's recommendation was disapproved by NMFS after considering the best available science. NMFS believes that the risk neutral medium recruitment scenario, instead of the Council's risk accepting recommendation, is supported by the best available science. With the April 15, 2002, emergency rule (67 FR 18117) extension herein, NMFS adopted a U.S. ABC of 166,000 mt and an OY of 129,600 mt, consistent with the risk neutral medium recruitment scenario.

Comment 2: The commenter requests that the treaty Indian tribal allocation of whiting be reduced to “reflect a percentage reduction equal to that imposed on non-tribal fishermen.”

Response: Presumably the commenter refers to the fact that the tribal share for 2001 was 14.4 percent of the OY, while for 2002 it is 17.5 percent (and would have been 16.4 percent under the PFMC proposal rejected by NMFS).

The tribal share is determined by a “sliding scale,” OY-based methodology. This methodology, which has been in use since 1999, provides for a slighter higher percentage of the OY to go to the treaty fishery at lower OY levels (to a maximum of 17.5 percent), with lower percentages to the treaty fishery at higher OY levels. The “sliding scale” methodology was used to set the tribal shares in both 2001 and 2002. For OYs under 145,000 (as in 2002), this method sets the tribal share at 17.5 percent.

The sliding scale methodology has been the subject of extensive litigation, which continues today. In United States v. Washington , the Court held that the “sliding scale” methodology is consistent with the Magnuson-Stevens Act, and is the best available scientific method to determine the appropriate allocation of whiting to the tribes. United States v. Washington 143 F.Supp.2d 1218 (W.D. Wash. 2001). This ruling was reaffirmed in July 2002. Midwater Trawlers Cooperative v. Daley , C96-1808R (W.D. Wash. 2002) (Order Granting Defendants' Motion to Supplement Record, July 17, 2002). Additional briefing will occur in this case. However, at this time NMFS remains under a Court Order in United States v. Washington to use the “sliding scale” methodology unless the Secretary of Commerce finds just cause for its alteration or abandonment, the parties agree to a permissible alternative methodology, or further order issues from the Court. As one of these events has not yet occurred, NMFS is obligated by the Court to continue to use the “sliding scale” methodology. Since the methodology already encompasses OYs at all levels, it is not appropriate to reduce the tribal share specified by the “sliding scale” methodology simply because the OY declines.