In an interim rule effective September 14, 2004, and published in the Federal Register on September 20, 2004 (69 FR 56157-56159, Docket No. 02-096-3), we amended the Oriental fruit fly regulations in § 301.93-3(c) by designating a portion of Orange County, CA, as a quarantined area because of an infestation of Oriental fruit fly and restricted the interstate movement of regulated articles from the quarantined area. We also amended § 301.93-10(b) to allow the use of spinosad bait spray as an alternative chemical treatment for premises. In a second interim rule effective on March 2, 2005, and published in the Federal Register on March 8, 2005 (70 FR 11111-11112, Docket No. 02-096-4), we amended the regulations by removing the portion of Orange County, CA, from the list of quarantined areas and removing restrictions on the interstate movement of regulated articles from that area based on our determination that the Oriental fruit fly had been eradicated from that area. Upon the effective date of our March 2005 interim rule, there were no longer any areas in the continental United States quarantined for the Oriental fruit fly.

Comments on each interim rule were required to be received on or before 60 days after the date of its publication in the Federal Register . We did not receive any comments on either of the interim rules. Therefore, for the reasons given in the interim rules, we are adopting the interim rules as a final rule.

This action also affirms the information contained in the interim rules concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This rule is issued under Marketing Agreement No. 121 and Order No. 915, both as amended (7 CFR part 915), regulating the handling of avocados grown in South 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. Under the marketing order now in effect, Florida avocado handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate herein is applicable to all assessable avocados beginning on April 1, 2005, and will 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 2005-06 and subsequent fiscal years from $0.20 to $0.27 per 55-pound bushel container or equivalent of avocados.

The Florida avocado 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 Florida avocados. 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 2002-03 and subsequent fiscal years, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal year to fiscal year 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 February 17, 2005, and recommended with a vote of nine in favor and one abstention, 2005-06 expenditures of $211,038 and an assessment rate of $0.27 per 55-pound bushel container or equivalent of avocados. In comparison, last year's budgeted expenditures were $241,568. The assessment rate of $0.27 is $0.07 more than the previous rate. The Committee recommended the $0.07 increase to rebuild its reserves which have been reduced in recent years. In 2003-04, the Committee estimated assessable production at one million containers but only harvested 660,000, causing the Committee to use its reserves to cover necessary expenses. In 2004-05, there was another shortfall of approximately 100,000 containers. Thus, 2004-05 assessments were reduced by approximately $20,000 and the Committee again had to use reserves to cover its expenses. The Committee reserves were estimated to be approximately $110,000 at the start of the new fiscal year that began April 1, 2005. The Committee expects 900,000 55-pound bushel containers to be harvested during the 2005-06 fiscal year. This is expected to result in approximately $32,000 in excess assessment income, which would increase the Committee's reserves to around $142,000.

The major expenditures recommended by the Committee for the 2005-06 year include $90,235 for salaries, $24,203 for insurance and bonds, $22,730 for employee benefits, $15,000 for research, and $10,000 for local and national enforcement. Budgeted expenses for these items in 2004-05 were $79,800, $26,093, $23,643, $21,000, and $43,135, respectively. The budget item local and national enforcement was reduced for 2005-06 because the compliance officer was hired as Committee manager and this person performs both compliance and managerial functions. The budget item for salaries reflects these function changes.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses and increase in reserves by expected shipments of Florida avocados. Avocado shipments for the year are estimated at 900,000 bushels which should provide $243,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve should be adequate to cover budgeted expenses. Funds in the reserve (estimated to be about $110,000 on April 1, 2005) will be kept within the maximum permitted by the order (approximately three fiscal years' expenses).

The assessment rate established in this rule continues 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 would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal year 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 2005-06 budget and those for subsequent fiscal years 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 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 150 producers of avocados in the production area and approximately 33 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 $6,000,000.

According to the National Agricultural Statistics Service and data provided by the Committee, the average Florida grower price for fresh avocados during the 2003-04 season was equivalent to $22.22 per 55-pound bushel container and total shipments were around 660,000 55-pound bushels. Approximately 11 percent of all handlers handled 76 percent of Florida avocado shipments. Using the average price and information provided by the Committee, nearly all avocado handlers could be considered small businesses under the SBA definition. In addition, based on production and grower prices, and the total number of Florida avocado growers, the average annual grower revenue is approximately $98,000. Thus, the majority of Florida avocado producers may also be classified as small entities.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2005-06 and subsequent fiscal years from $0.20 to $0.27 per 55-pound bushel of avocados. The Committee recommended 2005-06 expenditures of $211,038 and an assessment rate of $0.27 per 55-pound bushel of avocados. The assessment rate of $0.27 is $0.07 higher than the 2004-05 rate. The quantity of assessable avocados for the 2005-06 fiscal year is estimated at 900,000 55-pound bushels. Thus, the $0.27 rate should provide $243,000 in assessment income and be adequate to meet expenses.

The major expenditures recommended by the Committee for the 2005-06 year include $90,235 for salaries, $24,203 for insurance and bonds, $22,730 for employee benefits, $15,000 for research, and $10,000 for local and national enforcement. Budgeted expenses for these items in 2004-05 were $79,800, $26,093, $23,643, $21,000, and $43,135, respectively. The budget item local and national enforcement was reduced for 2005-06 because the compliance officer was hired as Committee manager and this person performs both compliance and managerial functions. The budget item salaries, reflects these function changes.

The Committee recommended the increase in the assessment rate to rebuild its reserves which have been reduced in recent years. In 2003-04, the Committee estimated assessable production at one million containers, but only harvested 660,000, causing the Committee to use its reserves to cover necessary expenses. For the 2004-05 season, production was approximately 100,000 containers below the Committee's estimate. Thus, 2004-2005 assessments were about $20,000 less than expected and the Committee had to use its reserves to cover expenses.

The Committee reserves were approximately $110,000 as the new fiscal year started on April 1, 2005. The Committee estimates 900,000 55-pound bushel containers will be harvested during the 2005-06 fiscal year. This is expected to result in $32,000 in excess assessment income, which would increase the Committee's reserves to around $142,000.

The Committee reviewed and recommended 2005-06 expenditures of $211,038 which included increases in administrative and office salaries, and insurance and bond programs. Prior to arriving at this budget, the Committee considered information from various sources, such as the Committee's Budget Subcommittee. Several alternative assessment and expenditure levels were discussed by these groups based on at what level to fund a research project and on how much they wanted to add to reserves. The assessment rate of $0.27 per 55-pound bushel container of assessable avocados was then determined by dividing the total recommended budget, including the increase in reserves, by the quantity of assessable avocados, estimated at 900,000 55-pound bushel containers or equivalents for the 2005-06 fiscal year. This is approximately $32,000 above the anticipated expenses, which the Committee determined to be acceptable.

A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average Florida grower price for the 2005-06 marketing season could range between around $15.00 and $22.00 per 55-pound bushel container or equivalent of avocados. Therefore, the estimated assessment revenue for the 2005-06 fiscal year as a percentage of total grower revenue could range between 1.2 and 1.8 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 are offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the Florida avocado industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the February 17, 2005, 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 Florida avocado 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 April 27, 2005 (70 FR 21682). Copies of the proposed rule were mailed or sent via facsimile to all Committee members and avocado handlers. Finally, the rule was made available through the Internet by USDA and the Office of the Federal Register. A 30-day comment period ending May 27, 2005, was provided to allow 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 matter 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 further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because handlers are already receiving 2005-06 crop avocados from growers, and the fiscal year began on April 1, 2005, and the assessment rate applies to all avocados received during the 2005-06 and subsequent seasons. Further, handlers are aware of this rule, which was recommended at a public meeting. Also, a 30-day comment period was provided for in the proposed rule and no comments were received.

This rule is issued under Marketing Agreement and Order No. 922 (7 CFR 922) regulating the handling of apricots grown in designated counties in Washington, 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, handlers in designated counties in Washington 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 Washington apricots beginning April 1, 2005, 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 2005-2006 and subsequent fiscal periods from $2.50 per ton to $1.00 per ton of fresh Washington apricots handled under the order.

The 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 Washington apricots. 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 at a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2004-2005 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate of $2.50 per ton of apricots handled. This assessment rate 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 10, 2005, and unanimously recommended 2005-2006 expenditures of $10,594—the same as last year's approved expenditures—and a decreased assessment rate of $1.00 per ton of apricots handled. The $1.00 assessment rate is $1.50 lower than the rate approved for the 2004-2005 and subsequent fiscal periods. Based on the Committee's 2005-2006 crop estimate of 3,800 tons, assessment income should approximate $3,800. The Committee recommended the lower assessment rate taking into account the anticipated crop shortfall on the industry, while also reducing the Committee's authorized monetary reserve to a level commensurate with program requirements. The anticipated $3,800 assessment revenue, when combined with $6,794 from the monetary reserves, is adequate to cover budgeted expenses for the 2005-2006 fiscal period. By drawing funds from the reserve (currently $13,962), the Committee estimates that by the end of the current fiscal period the reserve will approximate $7,168. This amount is within the maximum permitted by the order of approximately one fiscal period's operational expenses (§ 922.42).

The major expenditures recommended by the Committee for the 2005-2006 fiscal period include staff salaries ($5,892), rent and maintenance ($864), compliance ($100), and Committee travel and compensation ($1,000). These budgeted expenses are the same as those approved for the 2004-2005 fiscal period.

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 Committees 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 the Committee's meetings are available from the Committee or USDA. The Committee's meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate the Committee's 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 2005-2006 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 272 apricot producers within the regulated production area and approximately 28 regulated handlers. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,000,000.

For the 2004 apricot season, Washington Agricultural Statistics Service reported that the total 6,400 ton apricot utilization sold for an average of $973 per ton. Based on the number of producers in the production area (272), the average annual producer revenue from the sale of apricots in 2004 can thus be estimated at approximately $22,894. In addition, based on information from the Committee and USDA's Market News Service, 2004 f.o.b. prices ranged from $14.50 to $18.50 per 24-pound loose-pack container, and from $18.00 to $24.00 for 2-layer tray pack containers. With about half of the 2004 season fresh apricot pack-out of 4,911 tons in loose-pack containers and about half in tray-pack containers (weighing an average of about 20 pounds each), each of the industry's 28 handlers would have averaged less than $225,000 from the sale of fresh apricots. Thus, the majority of producers and handlers of Washington apricots may be classified as small entities.

This rule decreases the assessment rate established for the Committee and collected from handlers for the 2005-2006 and subsequent fiscal periods from $2.50 to $1.00 per ton of fresh apricots handled. The Committee unanimously recommended 2005-2006 expenditures of $10,594. With the 2005-2006 crop estimate of 3,800 tons, the Committee anticipates assessment income of $3,800, which, when combined with $6,794 from the monetary reserves, will be adequate to cover budgeted expenses for the 2005-2006 fiscal period. At this assessment rate and expense level, the Committee's reserve fund will approximate $7,168 by March 30, 2006. This amount is within the maximum permitted by the order of approximately one fiscal period's operational expenses (§ 922.42).

The Committee discussed alternatives to this rule, including alternative expenditure levels. Lower assessment rates were considered, but not recommended because they would not generate the income necessary to administer the programs.

A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the producer price for the 2005-2006 season could range from about $973 per ton to about $1,100 per ton for Washington apricots. Therefore, the estimated assessment revenue for the 2005-2006 fiscal period as a percentage of total producer revenue could range between 0.09 and 0.10 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 Washington apricot industries and all interested persons were invited to attend and participate in the Committee's deliberations on all issues. Like all marketing order committee meetings, the May 10, 2005, meeting was a public meeting and all entities, both large and small, were able to express views on the issues. 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 Washington apricot 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.ama.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 2005-2006 fiscal period began on April 1, 2005, and the order requires that the rate of assessment apply to all assessable Washington apricots handled during such fiscal period; (2) this action reduces the assessment rate; (3) handlers are aware of this action which was unanimously recommended 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 Agreement No. 97 and Marketing Order No. 948, both as amended (7 CFR part 948), regulating the handling of potatoes grown in Colorado, 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, Colorado potato 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 Colorado potatoes beginning July 1, 2005, 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 2005-2006 and subsequent fiscal periods from $0.03 to $0.02 per hundredweight of Colorado potatoes.

The 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 Colorado potatoes. 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 2003-2004 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate of $0.03 per hundredweight of potatoes handled. This assessment rate continues 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 12, 2005, and unanimously recommended 2005-2006 expenditures of $20,368 and an assessment rate of $0.02 per hundredweight of assessable potatoes handled. In comparison, last year's budgeted expenditures were $20,668. The assessment rate of $0.02 is $0.01 lower than the rate in effect since the 2003-2004 fiscal period. Due to increased potato yields and a reduction in expenses, the Committee's reserve has increased more than anticipated. The decreased assessment rate will allow the Committee to draw from the reserve to help cover 2005-2006 expenditures. This action should effectively lower the reserve to within the program limit of approximately two fiscal periods' operational expenses.

The major expenditures recommended by the Committee for the 2005-2006 fiscal period include $8,610 for salary, $3,000 for office rent, $1,750 for office expenses, and $1,000 for utilities. These budgeted expenses are the same as those approved for the 2004-2005 fiscal period.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Colorado potatoes. Applying the $0.02 per hundredweight rate of assessment to the Committee's 585,475 hundredweight crop estimate should provide $11,709 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 ($42,792 as of July 1, 2004) will be kept within the maximum of approximately two fiscal periods' operational expenses as authorized by the order (§ 948.78).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 2005-2006 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.

Based on Committee data, there are 8 producers and 8 handlers in the production area subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,000,000.

Based on the total number of Colorado Area No. 3 potato producers (8), 2003 fresh potato production of 1,041,958 hundredweight (Committee records), and the average 2003 producer price of $5.05 per hundredweight as reported by National Agricultural Statistics Service (NASS), average annual revenue per producer from the sale of potatoes can be estimated at approximately $657,736. In addition, based on Committee records and an estimated average 2003 f.o.b. price of $7.15 per hundredweight ($5.05 per hundredweight NASS producer price plus Committee estimated packing and handling costs of $2.10 per hundredweight), all of the Colorado Area No. 3 potato handlers ship under $6,000,000 worth of potatoes. In view of the foregoing, it can be concluded that the majority of the Colorado Area No. 3 potato producers and handlers may be classified as small entities.

This rule decreases the assessment rate established for the Committee and collected from handlers for the 2005-2006 and subsequent fiscal periods from $0.03 to $0.02 per hundredweight of potatoes. The assessment rate of $0.02 is $0.01 less than the 2004-2005 rate. The quantity of assessable potatoes for the 2005-2006 fiscal period is estimated at 585,475 hundredweight. 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 ($42,792 as of July 1, 2004) will be kept within the maximum of approximately two fiscal periods' operational expenses as authorized by the order (§ 948.78).

The major expenditures recommended by the Committee for the 2005-2006 fiscal period include $8,610 for salary, $3,000 for office rent, $1,750 for office expenses, and $1,000 for utilities. These budgeted expenses are the same as those approved for the 2004-2005 fiscal period.

Due to increased potato yields and a reduction in expenses, the Committee's reserve has increased more than anticipated. Therefore, the Committee recommended a decreased assessment rate to enable an increased draw on the reserve, thus maintaining the level of the reserve within program limits of approximately two fiscal periods' operational expenses.

The Committee discussed alternatives to this rule, including alternative expenditure levels, but determined that the recommended expenses were reasonable and necessary to adequately cover program operations. Lower assessment rates were considered, but not recommended because they would not generate the income necessary to administer the program.

A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the producer price for the 2005-2006 season could range between $5.05 and $7.75 per hundredweight. Therefore, the estimated assessment revenue for the 2005-2006 fiscal period as a percentage of total producer revenue could range between 0.40 and 0.26 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 Colorado potato industry and all interested persons were invited to attend and participate in the Committee's deliberations on all issues. Like all Committee meetings, the May 12, 2005, meeting was a public meeting and all entities, both large and small, were able to express views on the issues. 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 Colorado potato 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.ama.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 2005-2006 fiscal period begins on July 1, 2005, and the order requires that the rate of assessment apply to all assessable Colorado potatoes handled during such fiscal period; (2) this action decreases the assessment rate for assessable potatoes beginning with the 2005-2006 fiscal period; (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; 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. 981, as amended (7 CFR part 981), regulating the handling of almonds 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. 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. 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 revises the requirements regarding credit for promotion and advertising activities prescribed under the administrative rules and regulations of the order. Under the order, handlers may receive credit towards their assessment obligation for certain expenditures for marketing promotion activities, including paid advertising. This rule revises the requirements regarding the activities for which handlers may receive such credit. The changes will expand the credit allowed for certain promotional activities, and help to clarify and simplify the current regulations. This action was unanimously recommended by the Board at a meeting on May 12, 2005.

The order provides authority for the Board to incur expenses for administering the order and to collect assessments from handlers to cover these expenses. Section 981.41(a) provides authority for the Board to conduct marketing promotion projects, including projects involving paid advertising. Section 981.41(c) allows the Board to credit a handler's assessment obligation with all or a portion of his or her direct expenditures for marketing promotion, including paid advertising that promotes the sale of almonds, almond products, or their uses. Section 981.41(e) allows the Board to prescribe rules and regulations regarding such credit for market promotion, including paid advertising activities. Those regulations are prescribed in § 981.441. The Board recommended the following changes to those regulations.

Section 981.441(e)(4)(ii)(K) allows handlers to receive credit against their assessment obligation for the development and use of Web site activities on the Internet for advertising and public relations purposes. The allowable credit is currently limited to $5,000 per year, and no credit is given for costs regarding E-commerce (which is equivalent to opening a store).

The Board recommended increasing the credit allowed for Internet promotional activities from $5,000 to $20,000 per year, adding credit for E-commerce (except for administration costs), and clarifying that no credit would be given to Intranet (inter-office communication network). The Board determined that administration costs associated with E-commerce such as online payments and processing fees do not directly promote almonds and should thus be excluded from reimbursement under the program. This action would expand the allowable credit and activities concerning Web sites and thus provide handlers more flexibility. Section 981.441(e)(4)(ii)(K) is revised accordingly.

In order for handlers to receive credit against their assessment obligation for their own promotional expenditures, the Board must determine that such expenditures meet applicable requirements. Handlers must submit claims with appropriate documentation to the Board. Credit may be granted in the form of a payment from the Board, or as an offset to the Board's assessment if activities are conducted and documented to the satisfaction of the Board within certain time frames throughout the crop year.

Section 981.441(e)(6)(iv) currently requires handlers to submit a statement of all outstanding credit-back commitments in full to the Board as of the close of the crop year (July 31) within 15 days after the crop year ends (August 15). Additionally, handlers must submit final claims pertaining to such outstanding commitments to the Board within 76 days after the crop year ends (October 15).

The Board recommended adding language to this section to clarify that final claims must be submitted “with all required elements,” which includes invoices, proof of payment, and similar documentation. This will allow Board staff to process the final claims for a crop year and complete the necessary accounting functions to close the books for that crop year in a timely manner. Other comparable deadlines throughout the credit-back regulations contain this language. This addition will help to facilitate program administration. Section 981.441(e)(6)(iv) is revised accordingly.

Section 981.441 contains language throughout the section that refers to the 1998-99 crop year only. The Board recommended removing this language to help clarify and simplify the regulation. Section 981.441 is revised accordingly.

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 6,000 producers of almonds in the production area and approximately 115 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 of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,000,000.

Data for the most recently completed crop year indicate that about 48 percent of the handlers shipped over $6,000,000 worth of almonds and about 52 percent of the handlers shipped under $6,000,000 worth of almonds. In addition, based on production and grower price data reported by the California Agricultural Statistics Service (CASS), and the total number of almond growers, the average annual grower revenue is estimated to be approximately $261,248. Based on the foregoing, the majority of handlers and producers of almonds may be classified as small entities.

This rule revises the § 981.441 of the order's administrative rules and regulations regarding credit-back promotion and advertising. Under the order, handlers may receive credit towards their assessment expenditures for marketing promotion activities, including paid advertising. This rule increases the credit allowed for Internet promotion activities from $5,000 to $20,000 per year, adds credit for E-commerce (excluding administration), and clarifies that final reimbursement claims submitted to the Board by handlers for a crop year must include all applicable documentation. Additionally, this rule removes obsolete language from the regulations that was applicable to the 1998-99 crop year.

Regarding the impact of this rule on affected entities, it is estimated that, for the 2003-04 crop year, about 18 percent of the industry's handlers participated in the credit-back program administered under the order. Increasing the credit allowed for Internet promotion activities and adding credit for E-commerce will provide additional opportunities for handlers. The changes to specify that handlers must submit final claims with all required elements will help to facilitate program administration. Finally, removing obsolete language will clarify and simplify the regulations.

Regarding alternatives, the Board formed a task force that met on January 26, March 1, and April 1, 2005, to review the credit-back regulations. The task force considered several changes to the regulations, including whether handlers should receive credit for travel to trade shows, sponsorships, and sweepstakes. The task force also reviewed a handbook that Board staff developed to facilitate administration of the credit-back regulations. The task force's recommendations were reviewed by the Board's Public Relations and Advertising Committee on May 11, 2005, and by the full Board on May 12, 2005. Ultimately, the Board decided that the changes discussed herein are warranted at this time.

This action imposes no additional reporting or recordkeeping requirements on either small or large California almond handlers. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the information collection requirements that are contained in this rule have been previously approved by the Office of Management and Budget and assigned OMB No. 0581-0178. 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. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Additionally, the meetings were widely publicized throughout the California almond industry and all interested persons were invited to attend the meetings and participate in deliberations on all issues. Like all task force, committee and Board meetings, those meetings held on January 26, March 1, April 1, May 11, and May 12 were all public meetings 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.

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 rule invites comments on changes to the credit-back regulations under the California almond marketing order. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the information and recommendation submitted by the Board 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) This action needs to be in effect by August 1, 2005, the start of the 2005-06 crop year; (2) handlers are aware of this action which was unanimously recommended by the Board at a public meeting; (3) this action expands the opportunities for handlers to receive credit towards their assessment obligation for certain promotional expenditures which they conduct; 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.

The FAA proposed to amend 14 CFR part 39 with an AD for certain Airbus Model A300 B2 and B4 series airplanes; Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model C4-605R Variant F airplanes (collectively called A300-600 series airplanes); and Model A310-200 and -300 series airplanes. That action, published in the Federal Register on January 19, 2005 (70 FR 2985), proposed to require installing safety signs on all passenger/crew doors, emergency exit doors, and cargo compartment doors.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been submitted on the proposed AD.

One commenter notes that in paragraph (h) of the proposed AD, Airbus Service Bulletin A310-11-2002 is incorrectly referred to as Service Bulletin A300-11-2002. We infer that the commenter is requesting that we correct the typographical error. The commenter also notes a difference between the French airworthiness directive and the proposed AD, which could lead to requests for alternative methods of compliance from operators. The commenter points out that the proposed AD specifies the use of Service Bulletin A310-11-2002, Revision 03, dated February 4, 2004, and that actions accomplished before the effective date of the AD, in accordance with Revision 2, dated January 27, 1995, are acceptable for compliance with the actions specified in paragraph (g) of the proposed AD. The French airworthiness directive references Service Bulletin A310-11-2002, or any later approved revision. The commenter recommends that the original issue and Revision 1 of Service Bulletin A310-11-2002 be included in paragraph (h), “Credit for Previous Service Bulletins,” of the proposed AD.

We agree with the commenter's requests and have revised paragraph (h) of this AD to correct the typographical error and to reference the original issue and Revision 1 of Airbus Service Bulletin A310-11-2002.

Another commenter suggests that the installation of safety signs be limited to the main/crew door only, and that airplanes used only for cargo operations be exempted from the requirements of the proposed AD. The commenter points out that normal operation of the cargo doors is restricted to trained crewmembers and maintenance personnel, and the existing warning signs and crew procedural items have proven effective in its cargo operations. The commenter states that a history of flightcrews improperly opening crew doors does not seem to justify installing additional placards on all cargo doors.

We do not agree with the commenter's requests. Although the reported accidents occurred when crewmembers forcibly opened passenger/crew doors, the Direction Générale de l'Aviation Civile (DGAC) has notified us that the same unsafe condition also may exist on emergency exit and cargo doors. We have examined the DGAC findings, evaluated all pertinent information, and determined that we need to issue an AD parallel to French airworthiness directive F-2004-003, dated January 7, 2004. We point out that we did not receive similar comments from other cargo carriers, or any data substantiating that the commenter's request would ensure continued operational safety of the affected fleet. However, we will consider alternative methods of compliance in accordance with paragraph (i) of this AD.

We have revised the applicability of this AD to identify model designations as published in the most recent type certificate data sheet for the affected models.

We have carefully reviewed the available data, including the comments that have been submitted, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

This AD affects about 182 airplanes of U.S. registry. The required actions take about 5 work hours per airplane, at an average labor rate of $65 per work hour. Required parts will be provided at no charge. Based on these figures, the estimated cost of the AD for U.S. operators is $59,150, or $325 per airplane.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

The FAA proposed to amend 14 CFR part 39 with an AD for certain Boeing Model 737-300, -400, and -500 series airplanes. That action, published in the Federal Register on November 5, 2004 (69 FR 64534), proposed to require repetitive inspections for cracking of the crown area of the fuselage skin, and corrective actions if necessary.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been submitted on the proposed AD.

One commenter, the airplane manufacturer, requests that the proposed AD be revised to include the instructions provided to airplane operators in Boeing Communication System Activity 1-VN5QD. This Boeing Communication revises the repair and preventive modification procedures in Boeing Special Attention Service Bulletin 737-53-1234, dated June 13, 2002 (which is cited as the appropriate source of service information for the proposed AD). The revised procedures reduce the number of fasteners common to the first fastener row at the tear straps. The commenter states that the fastener size and pattern in the tear straps that are part of the procedures in the original issue of the service bulletin will not be consistent with future structural repair manual (SRM) repairs. These SRM repairs are currently being developed for Model 737-300, -400, and -500 series airplanes, with 20-inch tear strap spacing. The commenter explains that the fastener pattern and size difference in the SRM is being incorporated in an effort to maximize the “fail safety” of the repair by increasing the net area across the tear strap at the critical rows of the repair. The commenter points out that the procedures in the original issue of the service bulletin are adequate and do not contain an unsafe repair; however, there is a potential inconsistency between the service bulletin and the SRM. The commenter feels that this inconsistency would not represent best design practices given the potential number of repairs that could be required if a significant amount of chem-mill cracking occurs. The commenter further states that it is planning to revise Boeing Special Attention Service Bulletin 737-53-1234 to incorporate the instructions in Boeing Communication System Activity 1-VN5QD.

We partially agree with the commenter. We agree with the request to incorporate best design practices for repairs to the fuselage, because mandating an action with known obsolete information ultimately requires additional work for the industry. However, we disagree with including a Boeing Communication as part of the AD, because multiple sources of AD-mandated instructions can increase the potential for misinterpretation and non-compliance. In addition, since the time the comments were made, the commenter (the airplane manufacturer) has revised the repair information in the service bulletin to include the information in Boeing Communication System Activity 1-VN5QD. We have included this revision of the service bulletin (Boeing Special Attention Service Bulletin 737-53-1234, Revision 1, dated March 31, 2005) in the final rule as the appropriate source of service information for accomplishing the AD actions. Revision 1 adds no further work to the original issue of the service bulletin, but incorporates the information in Boeing Communication System Activity 1-VN5QD. The final rule mandates the revised service bulletin. We have also added a new paragraph (l) to the final rule, which allows credit for actions done in accordance with the original issue of the service bulletin. We have re-identified subsequent paragraphs accordingly.

The same commenter requests that we fix the typographical error “appropriateaction” in paragraph (j) of the proposed AD.

We have changed paragraph (j) of the final rule to read “appropriate action” instead of “appropriateaction.”

We have revised paragraph (j) of the final rule to allow any crack in the subject area to be repaired according to data that conform to the airplane's type certificate and that are approved by an Authorized Representative for the Boeing Delegation Option Authorization Organization whom we have authorized to make such findings.

We have revised paragraphs (i)(1), (i)(2)(i), and (i)(2)(ii) of the final rule to remove references to the notes in Part 2 and Part 3 of the Work Instructions in the original issue of the service bulletin. The notes are no longer in those parts of Revision 1 of the service bulletin. The information in the referenced notes is still required by this AD, but in Revision 1 of the service bulletin this information has been incorporated into the procedures of Part 2 and Part 3.

We have carefully reviewed the available data, including the comments that have been submitted, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 579 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this proposed AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

The FAA proposed to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) with an AD to supersede AD 98-20-17, amendment 39-10784 (63 FR 50979, September 24, 1998). The existing AD applies to Part Number (P/N) 021929-000 (McDonnell Douglas P/N 43BO34LB02) and P/N 021904-000 (McDonnell Douglas P/N 43BO34LB03) nickel cadmium batteries manufactured prior to December 1997 that are installed on, but not limited to, McDonnell Douglas DC-9 and MD-80 aircraft, all serial numbers. The proposed AD, which is applicable to certain McDonnell Douglas transport category airplanes, was published in the Federal Register on December 14, 2004 (69 FR 74461), to require replacing all battery terminal screws, verifying that the battery contains design specification cells, and replacing the cells if the battery contains non-design specification cells. The proposed AD also proposed to require an inspection for certain nickel cadmium batteries and, if necessary, replacing battery terminal screws with new hex head bolts and adding shims.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been submitted on the proposed AD.

One commenter requests that the proposed AD provide a better way of identifying the modification. The commenter states that identifying the modification with a sticker, as specified in SAFT Mandatory Service Bulletin 01-02, Revision 2, dated August 11, 2003, makes it difficult for airlines to track compliance. The commenter notes that stickers have been known to come unglued in the presence of water, acid, and heat, all of which exist around battery locations. If a sticker becomes unglued and lost, this gives the appearance of non-compliance to the AD. The commenter suggests requiring a P/N change on the data plate by simply adding a letter to the existing P/N.

We do not agree that a P/N change on the data plate is necessary in this case. Although we acknowledge that stickers may come unglued, the modification sticker is merely a secondary indication of compliance. We have determined that, for the purposes of this AD, installation of a compliance sticker, as specified in SAFT Mandatory Service Bulletin 01-02, Revision 2, dated August 11, 2003 (referenced as an additional source of service information in Boeing Alert Service Bulletin DC9-24A195, dated December 4, 2003), is not necessary. We find that recording the installation of the modified battery in the airplane maintenance records, as required by section 91.417 of the Federal Aviation Regulations, provides an adequate means for operators to track AD compliance. Therefore, we have revised paragraph (f)(2)(ii) of this AD to specify that installing a sticker is not required.

One commenter requests that two P/Ns be corrected. The commenter explains that certain P/Ns, as identified in the proposed AD, contain the letter “O” instead of the number “0.” The P/Ns should be 43B034LB02 and 43B034LB03.

We agree and have revised the AD accordingly.

We have added a new Note 2 to the AD to reiterate, as specified in the preamble of the proposed AD, that Boeing Alert Service Bulletin DC9-24A195, dated December 4, 2003, refers to SAFT Service Bulletin 01-02, Revision 2, dated August 11, 2003, as an additional source of service information for accomplishing the modification.

We have carefully reviewed the available data, including the comments that have been submitted, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 1,828 airplanes worldwide of the affected design. This AD will affect about 1,087 airplanes of U.S. registry.

The required inspection to determine if certain SAFT batteries are installed will take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the actions specified in this AD for U.S. operators is $70,655, or $65 per airplane.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 777-200 and -300 series airplanes was published as a supplemental notice of proposed rulemaking (NPRM) in the Federal Register on January 5, 2005 (70 FR 737). That action proposed to require a one-time inspection of the clevis end of the vertical tie rods that support the center stowage bins to measure the exposed thread, installation of placards that advise of weight limits for certain electrical racks, a one-time inspection and records check to determine the amount of weight currently installed in those electrical racks, corrective actions, and replacement of the vertical tie rods for the center stowage bins or electrical racks with new improved tie rods, as applicable.

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

Two commenters support the supplemental NPRM. One of these commenters states that the applicable requirements for its 19 affected airplanes will take 13 work hours to accomplish, with a parts cost of $2,072 per airplane. This is consistent with the costs estimated in the supplemental NPRM.

One commenter requests that we revise paragraph (d)(3) of the supplemental NPRM to extend the compliance time for accomplishing the inspection and records check to determine the weight of equipment installed in the subject electrical racks. The commenter notes that, by the time the AD is issued, it will have accomplished the actions specified in paragraphs (d)(1) and (d)(2) of the supplemental NPRM in accordance with the referenced service bulletin. However, it will not have accomplished the actions specified in paragraph (d)(3) of the supplemental NPRM because those actions are not specified in the service bulletin. The commenter requests that compliance time language similar to that in paragraph (a)(2)(i) of the supplemental NPRM be added to paragraph (d)(3). (Paragraph (a)(2)(i) of the supplemental NPRM gives a compliance time of up to 12 months after the effective date of the AD for checking the weight installed in certain electrical racks on airplanes on which the placard installation specified in paragraph (a)(1) has been accomplished before the effective date of the AD.)

We concur. The actions in paragraph (d)(3) of this AD are similar to those in paragraph (a)(2), and the compliance time should also be similar. Accordingly, we have revised paragraph (d)(3) of this AD, and added paragraphs (d)(3)(i) and (d)(3)(ii) to this AD, to allow up to 12 months for accomplishing the weight check on airplanes on which the actions in paragraphs (d)(1) and (d)(2) of this AD have been accomplished before the effective date of this AD.

The same commenter states that paragraph (e), “Actions Accomplished Previously,” contradicts the rest of the supplemental NPRM. The commenter states that paragraph (e) implies that no further work is necessary if a previous revision of the service bulletin was accomplished before the effective date of the AD. The commenter states that this would mean that the weighing of electrical racks, which is not referenced in the service bulletins, would not be done.

We do not agree. Paragraph (e) states that actions accomplished before the effective date of the AD per an earlier revision of the service bulletin are acceptable for compliance with corresponding actions required by this AD. For example, if placards were installed on electrical racks E7, E11, and E15, in accordance with the original issue of the referenced service bulletin, the placards would not have to be reinstalled in accordance with Revision 2 of the service bulletin. Because the procedures in the original issue of the service bulletin for accomplishing the placard installation are exactly the same as the procedures in Revision 2, there is no need to repeat the installation of placards to establish compliance with the AD. However, as paragraph (e) states, any actions in Revision 2 of the service bulletin ( e.g. , in Part 2 or 3 of the Accomplishment Instructions) that were not included in the original issue of the service bulletin must still be done in accordance with Revision 2. Likewise, the weighing of equipment that is specified in this AD is still required.

However, we agree that it is possible to clarify paragraph (e) of this AD in this regard. Therefore, we have added a sentence to paragraph (e) of this AD to state that the weighing requirements in paragraphs (a)(2) and (d)(3) of the AD must be accomplished at the applicable times identified in those paragraphs.

One commenter notes that information that it received from Boeing indicates that Boeing would be revising the service bulletin referenced in the supplemental NPRM. The commenter states that Boeing has indicated that Figure 8 of the service bulletin does not need to be done if the crew rest has been modified. The commenter states that, if Boeing doesn't update the service bulletin in time, operators of airplanes with the modified crew rest may have to request an alternative method of compliance (AMOC).

We infer that the commenter is requesting that we delay issuance of the final rule until Boeing has released the revised service bulletin. We do not concur. The revision of the service bulletin to which the commenter refers is not yet available. We find that it would be inappropriate to delay the issuance of this final rule to wait for the service bulletin to be revised. The commenter may request approval of an AMOC for the relevant requirements of this AD. The request must include data substantiating that the AMOC would provide an acceptable level of safety. We have not changed the final rule in this regard.

We have revised paragraphs (a), (b), (c), and (d)(1) of this final rule to state the compliance times in months ( i.e. , 60 months) instead of years ( i.e. , 5 years).

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 have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 282 airplanes of the affected design in the worldwide fleet. We estimate that 84 airplanes of U.S. registry will be affected by this AD.

For all airplanes: The records check and inspection to determine the weight currently installed in electrical rack E7 will take approximately 1 work hour per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this records check and inspection on U.S. operators is estimated to be $5,460, or $65 per airplane.

For all airplanes: It will take approximately 1 work hour to accomplish the installation of a placard specifying weight limits for electrical rack E7, at an average labor rate of $65 per work hour. Required parts will cost approximately $29 per airplane. Based on these figures, the cost impact of this placard installation on U.S. operators is estimated to be $7,896, or $94 per electrical rack.

For airplanes subject to the records check and inspection to determine the weight currently installed in electrical rack E9, E11, E13, or E15: It will take approximately 1 work hour per electrical rack (up to 4 racks per airplane) to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this records check and inspection is estimated to be as much as $260 per airplane.

For airplanes subject to the installation of a placard specifying weight limits for electrical rack E9, E11, E13, or E15: It will take approximately 1 work hour per electrical rack to accomplish, at an average labor rate of $65 per work hour. Required parts will cost approximately $29 per electrical rack. Based on these figures, the cost impact of this installation is estimated to be as much as $376 per airplane.

For airplanes subject to the inspection of the clevis end of the vertical support tie rod for the center stowage bin to measure the exposed thread: It will take as much as 3 work hours per airplane (0.25 work hour per tie rod, with up to 12 subject tie rods per airplane) at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this inspection is estimated to be as much as $195 per airplane.

For airplanes subject to the replacement of the vertical tie rods that support the center stowage bins: It will take as much as 6 work hours per airplane (0.5 work hour per tie rod, with up to 12 subject tie rods per airplane) at an average labor rate of $65 per work hour. Required parts will cost as much as $3,020 per airplane. Based on these figures, this replacement is estimated to be as much as $3,410 per airplane.

For airplanes subject to the replacement of the vertical tie rods that support the electrical racks: It will take as much as 2 work hours per airplane (0.5 work hour per tie rod with up to 4 subject tie rods per airplane) at an average labor rate of $65 per work hour. Required parts will cost as much as $3,012 per airplane. Based on these figures, this replacement is estimated to be as much as $3,142 per airplane.

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

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Boeing Model 737-100, -200, and -200C series airplanes was published as a supplemental notice of proposed rulemaking (NPRM) in the Federal Register on April 1, 2005 (70 FR 16761).

We provided the public the opportunity to participate in the development of this AD. We have considered the comment that has been submitted on the proposed AD.

The commenter supports the proposed AD.

We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD as proposed.

This is considered to be interim action. The manufacturer has advised that it is developing an improved preventive modification intended to address the identified unsafe condition for unmodified skin areas. After this modification is developed, approved, and available, we may consider additional rulemaking.

There are about 1,000 airplanes of the affected design in the worldwide fleet. The FAA estimates that 390 airplanes of U.S. registry will be affected by this AD.

The inspection will take about 47 to 88 work hours per airplane (depending on configuration), at an average labor rate of $65 per work hour. Based on these figures, we estimate the cost of the inspection to be $3,055 to $5,720 per airplane, per inspection cycle.

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.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

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

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

The FAA proposed to amend 14 CFR part 39 with an AD for all Fokker Model F.28 Mark 1000, 2000, 3000, and 4000 airplanes. That action, published in the Federal Register on April 6, 2005 (70 FR 17345), proposed to require a detailed inspection to determine the presence of incorrectly installed bushings in the attachment holes of the reinforcing strap of the left- and right-hand wings' lower skin, and corrective actions if necessary.

We provided the public the opportunity to participate in the development of this AD. No comments have been submitted on the proposed AD or on the determination of the cost to the public.

We have revised the applicability of the proposed AD to identify model designations as published in the most recent type certificate data sheet for the affected models.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

The FAA proposed to amend 14 CFR part 39 with an AD for certain Airbus Model A300 B2 and B4 series airplanes. That action, published in the Federal Register on April 6, 2005 (70 FR 17347), proposed to require modifying the wiring of the autopilot pitch torque limiter switch.

We provided the public the opportunity to participate in the development of this AD. We have considered the one comment that has been submitted on the proposed AD.

The commenter supports the proposed AD.

We have updated reference to Airbus Model A300 B2 and B4 series airplanes in paragraph (c) of this AD to match the common model designation identified in the latest revision of the type certificate data sheet.

We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD as proposed.

This AD affects about 20 airplanes of U.S. registry. The actions take between 8 and 11 work hours per airplane, depending on airplane configuration, at an average labor rate of $65 per work hour. Required parts cost between $1,840 and $4,280 per airplane, depending on airplane configuration. Based on these figures, the estimated cost of the AD for U.S. operators is between $47,200 and $99,900, or between $2,360 and $4,995 per airplane.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

The FAA proposed to amend 14 CFR part 39 with an AD for certain Boeing Model 777-200 and -300 series airplanes. That action, published in the Federal Register on March 22, 2005 (70 FR 14430), proposed to require inspecting for the installation of the tie plate for the wire bundles routed from lower section 41 into the center control stand in the flight deck; inspecting for any wire chafing or damage and repair if necessary; and installing a tie plate if necessary.

We provided the public the opportunity to participate in the development of this AD. We have considered the comment that has been submitted on the proposed AD. The commenter supports the proposed AD.

We have carefully reviewed the available data, including the comment that has been submitted, and determined that air safety and the public interest require adopting the AD as proposed.

There are about 289 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

In 1995, the Commission issued a regulation under the Poison Prevention Packaging Act (“PPPA”) requiring child resistant (“CR”) packaging for lidocaine products with more than 5 milligrams (mg) of lidocaine in a single package. 16 CFR 1700.14 (a)(23).

Lidoderm® is a single-use dermal patch that contains lidocaine. Lidoderm® is prescribed to treat post-herpetic neuralgia (“PHN”), a rare, chronic condition that results from nerve injury caused by shingles. Each Lidoderm® patch contains 700 mg lidocaine. Under the PPPA, if a product requires special packaging, the immediate container of the product must be CR. This means that for Lidoderm® to comply with the PPPA, each patch must be packaged in an individual CR pouch, or multiple patches that are not packaged in individual CR pouches must be packaged together in a single resealable CR pouch without envelopes.

On August 14, 2000, the manufacturer of Lidoderm®, Endo Pharmaceuticals Inc. (“Endo”), petitioned the Commission for a partial exemption for Lidoderm® from special packaging requirements stating that “it is not practicable to market each Lidoderm® patch in a child-resistant envelope.” At that time, Lidoderm® was marketed in the form of five patches inside a non-CR resealable envelope. One non-CR carton of Lidoderm® contained six envelopes (each envelope contained five patches) for a total of 30 patches per carton. Endo asserted that placing each patch in a CR envelope would be cost prohibitive and would force it to discontinue production of Lidoderm®.

The Commission declined to issue the exemption that Endo requested because, as explained in the August 30, 2001 stay notice, under the PPPA, the expense of special packaging cannot be the basis for an exemption. 66 FR 45842. However, the Commission did agree to stay enforcement of the special packaging requirements for Lidoderm® under certain conditions specified in the notice of the stay. Id.

Endo has informed the Commission that it is now packaging Lidoderm® patches in CR packaging in full compliance with the PPPA requirements (each single-use patch is packaged in an individual CR pouch). Because the stay of enforcement is no longer necessary, the Commission has decided to lift the stay. This means that Lidoderm®, like any other item requiring special packaging under the Commission's PPPA regulations, must comply with all PPPA special packaging requirements.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and for making this rule effective less than 30 days after publication in the Federal Register . Publishing a NPRM would be contrary to public interest since immediate action is necessary to ensure the safety of vessels and spectators gathering in the vicinity of the various fireworks launching barges and displays. If normal notice and comment procedures were followed, this rule would not become effective until after the dates of the events. For this reason, publishing an NPRM and making this rule effective less than 30 days after publication in the Federal Register in this case would be impracticable and contrary to the public interest.

The Coast Guard is establishing temporary safety zones to allow for safe fireworks displays. All events occur within the Captain of the Port, Portland, OR, Area of Responsibility (AOR). These events may result in a number of vessels congregating near fireworks launching barges and sites. The safety zones are needed to protect watercraft and their occupants from safety hazards associated with fireworks displays. This safety zone will be enforced by representatives of the Captain of the Port, Portland, Oregon. The Captain of the Port may be assisted by other Fderal and local agencies.

This rule, for safety concerns, will control vessels, personnel and individual movements in a regulated area surrounding the fireworks event indicated in section 2 of this Temporary Final Rule. Entry into these zones is prohibited unless authorized by the Captain of the Port, Portland or his designated representative. Captain of the Port, Portland, Oregon, will enforce these safety zones. The Captain of the Port may be assisted by other Federal and local agencies.

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 this rule under that Order. This rule is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures act of DHS is unnecessary. This expectation is based on the fact that the regulated areas established by the proposed regulation will encompass small portions of the Columbia, Willamette, Coos, Chehalis and Siuslaw Rivers in the Portland AOR on different dates, all in the evening when vessel traffic is low.

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.

This Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit a portion of the Willamette, Columbia, Coos, Chehalis and Suislaw Rivers during the times mentioned in section 2(a)(1-8) at the conclusion of this rule. These safety zones will not have significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only sixty minutes during two evenings when vessel traffic is low. Traffic will be allowed to pass through the zone with the permission of the Captain of the Port or his designated representatives on scene, if safe to do so.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. 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 State, local, or tribal government, in the aggregate, or the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect 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.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule establishes safety zones which have a duration of no more than two hours each. Due to the temporary safety zones being less than one week in duration, an Environmental Checklist and Categorical Exclusion is not required.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553 (b)(B), the Coast Guard finds that good cause exists for not publishing a NRPM. Publishing a NPRM, which would incorporate a comment period before a final rule could be issued and delay the rule's effective date, is contrary to public interest because immediate action is necessary to protect the public and waters of the United States.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . The Coast Guard will issue a broadcast notice to mariners and will place Coast Guard vessels in the vicinity of this zone to advise mariners of the restriction.

This rule is needed to protect spectator craft in the vicinity of the fireworks presentation from the hazards associated with the storage, preparation and launching of fireworks. Anchoring, mooring, or transiting within this zone is prohibited, unless authorized by the Captain of the Port, Jacksonville, FL. The temporary safety zone encompasses all waters within 500 yards in any direction around the fireworks barge during the storage, preparation and launching of fireworks. During the fireworks show, the barge will be located at approximate position 30°15′00″ N, 081°41′10″ W.

This regulation 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 the order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time and the impact on routine navigation is expected to be minimal.

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

The Coast Guard certifies under 5 U.S.C. 605 (b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for a short period of time and the impact on routine navigation is expected to be minimal.

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 the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

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

This rule calls for no new collection of information 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 my result in the expenditure by State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Although 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 affect 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 significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Due to the complex planning and coordination involved, final details for the Tacoma Tall Ships 2005 event were not provided to the Coast Guard until May 23, 2005, making it impossible to publish a NPRM or a final rule 30 days in advance.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay in implementing this rule will be contrary to the public interest due to the risks inherent in this high visibility marine event with the participation of a large number of spectator and participating vessels.

Tacoma, Washington will host the Tacoma Tall Ships 2005 festival from June 30 to July 4, 2005. While the Tacoma Tall Ships 2005 event is not an annual event, this visit of vessels is part of an annual series of sail training races, rallies, cruises, and port festivals organized by the American Sail Training Association (“ASTA”) in conjunction with host ports in the United States and Canada.

The Tall Ships' visit to Tacoma, Washington will include a Parade of Sail into Tacoma on June 30, 2005, and simulated cannon battles from July 1 to July 4, 2005. Approximately 28 sailing vessels are expected to participate in the Parade of Sail. There will be vessels participating in the event from several foreign countries and the high visibility of this event warrants that a safety zone be established to safeguard participating vessels, their crews and the maritime public.

This rule creates safety zones for the Tacoma Tall Ships 2005 event. The regulations will be in effect in Quartermaster Harbor and Commencement Bay, Washington from June 30, 2005 until July 4, 2005 during the Parade of Sail and simulated cannon battles. Vessel congestion due to the large number of participating and spectator vessels poses a significant threat to the safety of life and property. This temporary rulemaking is necessary to ensure the safety of life and property on the navigable waters in Quartermaster Harbor and Commencement Bay by preventing the large number of spectator vessels from interfering with the organized events.

The Coast Guard will establish moving Safety Zones surrounding the Tall Ships participating in the Tacoma Tall Ships 2005 Parade of Sail and simulated cannon battle events. The Safety Zones will be in effect in Quartermaster Harbor and Commencement Bay, Washington. These Safety Zones will be used for the participating vessels of the Tacoma Tall Ships 2005 event and is effective from 6 a.m. PDT on June 30, 2005 to 11:59 p.m. PDT on July 4, 2005. These Safety Zoned are designed to fit the needs of safety by facilitating the transit of participating vessels and minimizing the impact on the maritime community.

This rule will provide for the safety of spectator craft, mariners, and the Tall Ships themselves while the Tall Ships are participating in the Parade of Sail and simulated cannon battles. During the Parade of Sail, the Tall Ships will be underway, most likely under sail, and with limited mobility. The actual Parade of Sail is scheduled to last approximately ten hours, beginning at 10 a.m. PDT on June 30, 2005 and ending at approximately 8 p.m. PDT on June 30, 2005. The parading vessels will muster at a staging area in Quartermaster Harbor, and will then transit south in Commencement Bay to the Thea Foss Waterway.

This rule, for safety concerns, will control vessel movement in a regulated area surrounding the Tall Ships. For the purpose of this regulation, a Tall Ship means any vessel participating in Tacoma Tall Ships 2005. No vessel except for a public vessel may enter, remain in, or transit within the Safety Zone, unless authorized by the Coast Guard COTP Puget Sound or his on-scene designated representatives. Designated representatives of the Coast Guard COTP Puget Sound are defined as commissioned, warrant, and petty officers of the U.S. Coast Guard. Each person or vessel in a safety zone shall obey any direction or order of the COTP or his designated representatives. Public vessels for the purpose of this Temporary Final Rule are vessels owned, chartered, or operated by the United States, or by a State or political subdivision thereof.

Vessels requesting to enter, remain in, or transit within the Safety Zone shall contact the on-scene official patrol on VHF-FM channel 13. In addition, measures or directions issued by Vessel Traffic Service Puget Sound pursuant to 33 CFR part 161 shall take precedence over the regulations in this Temporary Final Rule. Similarly, when a Tall Ship approaches within 50 yards of any vessel that is moored or anchored, the stationary vessel must stay moored or anchored while it remains in the Tall Ship's safety zone unless it is either ordered by, or given permission by the Captain of the Port, his designated representative or the on-scene official patrol to do otherwise.

Sector Seattle maintains a telephone line that is manned 24 hours a day, 7 days a week. The public can contact Sector Seattle at (206) 217-6002 to obtain information concerning enforcement of this rule.

This Safety Zone regulation is enforceable by the terms set forth by 33 United States Code (U.S.C.) 1232. Enforcement of violations of these regulations may include, in addition to any civil and criminal penalties authorized by 33 U.S.C. 1232, in rem liability against the offending vessel as well as license sanctions against the offending mariner.

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 this rule under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

Although this rule restricts access to the regulated area, the effect of this rule will not be significant because: (i) Individual Tall Ships safety zones are limited in size; (ii) the official on-scene patrol may authorize access to the Tall Ship safety zone; (iii) the Tall Ship safety zone for any given transiting Tall Ship will affect a given geographical location for a limited time; and (iv) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

Additionally, the safety zones have been narrowly tailored to impose the least impact on maritime interests yet provide the level of safety and protection deemed necessary.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which might be small entities: the owners or operators of vessels intending to operate near or anchor in the vicinity of Tall Ships in the navigable waters of the United States affected by this rule.

These safety zones will not have a significant economic impact on a substantial number of small entities for the following reasons. The regulations affecting navigation in Quartermaster Harbor and Commencement Bay will be in effect temporarily, and only for those periods of time necessary for the safety of the Tacoma Tall Ships 2005 event participants. Recreational vessel traffic can pass safely around designated safety zones. Before the effective periods, the Coast Guard will make notification to the public via Local Notices to Mariners and Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), the Coast Guard wants to assist small entities in understanding this rule so that they may better evaluate its effects on them and participate in the rulemaking process.

If you think that this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

In addition, small businesses may make 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 will 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 expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect 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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that will limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. Due to the temporary safety zone being less than one week in duration, an Environmental Checklist and Categorical Exclusion is not required.

The regulation re-inserted explains the loan program for blind and physically handicapped persons and the criteria for eligibility to participate.

On August 5, 2002, at 67 FR 50600, EPA published a completeness determination that the Ohio NO X SIP submittal contained all of the elements of a NO X plan required for review. On January 16, 2003, at 68 FR 2211, we published a direct final rule approving Ohio's submittal. This rule was withdrawn on March 17, 2003, at 68 FR 12590, before it became effective because EPA received an adverse comment on the flow control issue. On August 5, 2003, at 68 FR 46089, having resolved the flow control issue, EPA approved Ohio's NO X State Implementation Plan (SIP), designed to reduce NO X emissions from major fuel burning sources during the ozone season. The Ohio NO X SIP specifically addressed emissions from sources named in Ohio Administrative Code (OAC) rules 3745-14 appendices A and B. These 2 appendices identify sources by location and plant identification number, and list NO X allocations for each plant. Appendix B lists NO X allowance allocations for the ozone season for regulated non-electrical generating units (non-EGUs).

Following the August 5, 2003 approval, EPA issued an NO X SIP Call applicability statement which clarifies inclusion of a specific NO X source category (carbon monoxide (CO) boilers) and gives States the option to include or exclude this source category of boilers in the trading program. These CO boilers are associated with fluidized catalytic cracking units (FCCU) found in oil refineries and used to combust, and thereby control, CO emissions and to produce steam for use at the refinery. NO X is produced by a refinery's FCCU and CO boiler and these emissions vent through the boiler stack. As fuel burning sources, these units could be included in the NO X trading program if the State so desired. The EPA applicability statement gives this option to the States.

The Ohio NO X SIP Call inventory for non-EGUs includes some, but not all, FCCU-CO boilers. Two boilers were regulated at one refinery but not regulated at two similar FCCU-CO units at two other refineries. These inventory inconsistencies existed as well at other state inventories in NO X SIP Call states. Because of these inconsistencies from state to state, EPA developed its applicability statement to allow each state with one or more FCCU-CO boiler the option of determining whether all of its large FCCU-CO boilers are covered, or all of its large FCCU-CO boilers are not covered by the NO X SIP trading program. However, in this option, EPA does not intend to allow states to split this category of sources by including some, but not all, large FCCU-CO boilers in the trading program. To prevent splitting the category, EPA needed to provide an explanation as to how allowances would be addressed for states like Ohio, with some but not all FCCU-CO sources in the rule.

Today's final rule resolves the issue of applicability of Ohio's rule to certain fuel burning units. It is intended to give affected sources in Ohio a clear indication that CO boilers associated with fluidized catalytic cracking units (FCCU) at oil refineries are not subject to Ohio's NO X budget trading rule. This action excludes selected units from the NO X budget trading program and the monitoring requirements of the State rule, and clears up for owners of these sources the questions of whether or not monitoring, record-keeping and reporting requirements are required for these sources.

This rule revision affects all refineries in Ohio which have carbon monoxide boilers associated with fluidized catalytic cracking units. There are three refineries in Ohio which are affected by this rule change. However, since the beginning of the NO X trading program, all three refineries have been granted an exemption from the monitoring, recordkeeping and reporting requirements of the Ohio NO X budget rule and the requirements of the NO X SIP Call. The exemption was granted in writing by EPA and applied to specific units classified by the State as small units.

Ohio made a number of changes to the NO X rules as noted in Table I, below.

The Ohio NO X plan revision was reviewed based on the elements set forth in Appendix V, 40 CFR part 51.

The State's submittal included: a formal letter requesting approval of the rule revision; evidence of legal authority; evidence that the rules were adopted in the Ohio Code; a copy of the rule; evidence that Ohio followed the requirements of the State's administrative procedures act; copy of the public notice; evidence that a public hearing was held; and copy of public comments.

The submittal included a revised budget demonstration, describing the changes to the Ohio NO X emission budget and the NO X trading budget. Following original EPA approval of the Ohio NO X plan, the State discovered that an existing unit at the Premcor Refinery in Lima, Ohio should have been included in the rules as a regulated unit but was not. It is included because the unit is classified by Ohio as a large unit subject to the Ohio rule. OEPA also discovered that the rules regulated two CO boilers associated with FCCU boilers at the Sunoco Refinery in Ohio and did not regulate two similar FCCU-CO boilers, one belonging to Premcor Refinery and one at BP Toledo Refinery. These corrections are made in the Ohio rule revision. Ohio also learned that EPA had given other States the option of regulating or not regulating similar FCCU-CO boilers, and moved to make these changes to its rules. On the basis of this information, Ohio initiated a change to its trading rules which were made effective on May 5, 2004.

CO boilers associated with fluidized catalytic cracking units at oil refineries are classified as small units and, therefore, not required to be part of the NO X trading program. This has significant effect on annual operating costs for monitoring and reporting for owners of these boilers. Allowances, made available in Ohio's original rule, are no longer available for these units, and potential income from the sale of emission reduction credits no longer exists. More importantly for the owners of the sources, because these units are not part of the trading program, there is no longer a requirement for these sources to monitor, record and report emissions of NO X for these units under 40 CFR part 75. This relieves the owners of these sources from the substantial burden and expenses associated with the monitoring requirements of the Ohio trading rule.

The Clean Air Act (Act) requires States to allow the public an opportunity to review and comment on any State's plan to implement provisions of the Act. Section 110(a)(1) of the Act states, “Each State shall, after reasonable notice and public hearings, adopt and submit to the Administrator * * * a plan * * *”. Ohio provided reasonable notice and public input.

Ohio's Revised Administrative Code states that the Director of the Ohio Environmental Protection Agency “may conduct public hearings on any plan for the prevention, control, and abatement of air pollution that the director is required to submit to the Federal government.” (Ohio Revised Code Chapter 3704.03, Powers of the director of environmental protection.) On October 21, 2003, Ohio advised the affected community of a proposed rulemaking and public hearing concerning Rules 3745-14-01, 3745-14-03, and 3745-14-05 of the Ohio Administrative Code. Notice was made available to the public and affected industries via Ohio EPA's Web site and by direct electronic mail to the State's list of interested parties. This notice announced a thirty-day comment period beginning October 21, 2003. Comments were received and the rule was revised in response to the comments and again made available on the State's Web site. A public hearing was held in Columbus on March 11, 2004, at which no comments were made, and no comments were received via either U.S. Mail or electronic mail.

Ohio published a notice of adoption of amended rules, and in the notice offered its citizens, and affected industry, an opportunity to appeal the Ohio EPA Director's findings and orders, and again sent an announcement of this opportunity to the list of interested parties. No appeals were made. The revision was approved by the Director and became effective on May 5, 2004.

EPA is approving this revision because it conforms with the intent of EPA's applicability statement regarding boilers associated with fluidized catalytic cracking units located at oil refineries. This applicability statement or policy is available from the EPA Clean Air Markets Division (CAMD). A copy of this policy is available at the following web link: http://www.epa.gov/airmarkets/fednox/boilerpolicy.pdf. The intent of the policy has been articulated in letters to all three sources in Ohio which are affected by the Ohio NO X rule. 1 In anticipation of the pending changes to the Ohio trading rule, these sources petitioned EPA and Ohio to exempt specific units from the requirements of OAC 3745-14-01, the monitoring, recordkeeping and reporting requirement of the Ohio NO X trading rule.

Prior to the May 31, 2004 start of the trading program, EPA had already exempted these small sources from the monitoring requirements. The exemptions were based on requests from the sources, and were made with the understanding that Ohio, with guidance from EPA, would amend its rules to exempt these sources from monitoring, and submit the rules to EPA to formalize the revision to the Ohio NO X plan. EPA agreed with the exemptions because the units at these sources are considered small emitters and were not factored into the cost-effectiveness determination in the development of the original EPA rule. 63 FR 57356, October 27, 1998. Also, many of these units which are classified as CO emission control equipment in some state inventories are not significant emitters of NO X . EPA did not intend these units to be included in the NO X trading program because the emissions from this category were relatively small (less than 1 ton per day) 63 FR 57356, October 27, 1998. Ohio corrected this applicability issue by revising the State rule to exempt these units from the requirements of the NO X program. EPA agrees with the State's revision.

EPA received two documents commenting on the direct final rule pertaining to the Ohio NO X SIP Call revision published in the Federal Register on January 19, 2005, at 70 FR 2954 EPA noted in the proposed rule also published on January 19, 2005, at 70 FR 2992, that if EPA received written comments, the direct final rule will be withdrawn and all written public comments received during the comment period will be addressed in a subsequent final rule based on the proposed rule. EPA, in the proposed rule, invited any party interested in commenting on the action to do so within the time-frame noted in the proposed rule.

Whenever EPA receives adverse comments on the rule, it is required to published a withdrawal of the direct final rule within 30-days from the date of the close of the comment period. In this instance the withdrawal of the direct final approval of the Ohio revised NO X rule was published on March 14, 2005, at 70 FR 12416, within the time period required by EPA procedures.

In addition to the two written comments on this action, EPA received several telephone inquires regarding the revision to the Ohio NO X trading rule. However, these phone calls were not intended by the callers to comment on the rule changes, but conveyed questions regarding EPA procedures and timing of the subsequent final rule or action. EPA did not receive any written comments resulting from these phone calls, and therefore, the details of the content of these telephone inquires will not be addressed in this final rule.

Two written comments were submitted addressing the direct final rule. One comment came from an anonymous citizen via the Federal eRulemaking Portal through the Regional Materials in eDocket (RME) identification number R05-OAR-2004-OH-0003, and one comment was received from Ohio Environmental Protection Agency (OEPA) via the U.S. Postal Service. Both of these comments are available for viewing by the public in the RME using the above noted identification number.

The citizen comment notes that the commenter's daughter has asthma and expresses concern that the Social Security Administration terminated disability payments. The comment does not address EPA's proposed action on Ohio's NO X rules. Thus the comment provides no reason for EPA's final action to differ from its proposed action.

The OEPA submitted a comment suggesting corrections to errors in the text of the approval in the direct final rule. We incorrectly included in the direct final rule a number of changes to the State's rule which had not yet been given public notice and comment in the State's rulemaking procedure. These errors are corrected in this final rule. The direct final rule also refers to a unit in the Ohio inventory which was misidentified by the State in its original submittal. These changes are reflected in the revised text and appear as requested by Ohio EPA in its comments on the direct final rule. The intent of this final rule remains the same as the previously published direct final rule. EPA agrees with Ohio and is approving the revision which exempts FCCU-CO boilers from requirements of the trading program.

We are approving Ohio's revision to the State's NO X plan because it continues to meet the requirements of the EPA NO X trading program. The State's revision makes a minor adjustment in the overall trading budget which EPA had confirmed was approvable. EPA agreed with Ohio prior to the start of the 2004 ozone season that this change would be approved and that affected FCCU-CO boilers would not be required to implement NO X rule requirements as long as Ohio continued to make progress to change the rules. The rule changes affecting the definition of boiler and adjusting the budget became effective in the State on May 5, 2004. This adjustment in the budget was recognized by EPA as a necessary change to accommodate Ohio's change in the definition of “boiler” in the State rule. EPA is publishing this action as a final rule because it serves to implement the intent of the NO X SIP Call and EPA policy and improves operation of Ohio's NO X plan.

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 plan 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 plan 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. 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. 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 August 26, 2005. 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 wherever “we,” or “our” are used we mean EPA.

This document corrects an error which may prove to be misleading in title 40 CFR, part 62, chapter I, subpart GG. In 70 FR 1668-1670 (January 10, 2005), we added a new § 62.7881 with the same designated center heading as § 62.7890. By renaming § 62.7890 to “Identification of sources—negative declarations''; redesignating the existing paragraph to paragraph (a); and adding a new paragraph (b), will correct the added undesignated center heading to subpart GG and remove the added § 62.7881 with the same designated center heading as § 62.7890.

Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore 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)). Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedures Act or any other statute as indicated in the SUPPLEMENTARY INFORMATION section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also 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, as specified by Executive Order 13175 (59 FR 22951, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of governments, as specified by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant. This technical correction action does not involve technical standards; thus [[Page 31890]] the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1998) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under 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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of May 14, 2004. 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 correction to 40 CFR 62.7890 for Bernalillo County is not a “major rule” as defined by 5 U.S.C. 804(2).

The information presented in this preamble is organized as follows:

EPA is publishing this regulation under the authority of sections 2002, 3001, 3002, 3003, 3006, 3007, 3010, 3013, and 7004 of the Solid Waste Disposal Act of 1970, as amended by the Resource Conservation and Recovery Act, as amended (42 U.S.C. 6912, 6921, 6922, 6923, 6926, 6927, 6930, 6934, and 6974).

The Final Project Agreement (FPA) sets forth the intentions of EPA, Pennsylvania Department of Environmental Protection (PADEP), and the OMP Spring House facility with regard to a project developed under Project XL, an EPA initiative that allows regulated entities to achieve better environmental results with additional regulatory flexibility. This final regulation, along with the FPA (contained in the docket for this rule under Docket ID No. RCRA-2001-0021), will facilitate implementation of the project. Project XL —“eXcellence and Leadership”— was announced on March 16, 1995, as a central part of the Agency's effort to reinvent environmental protection. See 60 FR 27282 (May 23, 1995). Project XL provides a limited number of private and public regulated entities an opportunity to develop their own pilot projects to request regulatory flexibility that will result in environmental protection that is superior to what would be achieved through compliance with current and reasonably-anticipated future regulations. For more information about the XL Program in general, and XL project criteria and project development processes in detail, readers should refer to http://www.epa.gov/projectxl/ . Additional background information on the proposed OMP Spring House Project XL site-specific rulemaking published is available at http://www.epa.gov/projectxl/ortho/index.htm and published in the Federal Register , specifically: July 24, 2001 (66 FR 38396), two descriptive documents published in the Federal Register (60 FR 27282, May 23, 1995 and 62 FR 19872, April 23, 1997), and the December 1, 1995 “Principles for Development of Project XL Final Project Agreements” document. For further discussion as to how the OMP Spring House XL project addresses the XL criteria, readers should refer to the Final Project Agreement available from the EPA RCRA docket (Docket ID No. RCRA-2001-0021; see ADDRESSES section of today's preamble).

Today's final rule will facilitate implementation of the FPA that has been developed by EPA, PADEP, the OMP Spring House facility, and other stakeholders. Today's final rule will become effective under Pennsylvania State law in accordance with the Commonwealth's hazardous waste program, as described further in section IV of this preamble.

To implement this XL project, today's final rule provides a site-specific exemption from the regulatory definition of hazardous waste for the mixed wastes generated and treated in OMP's Spring House research and development laboratory. The terms of the overall XL project are contained in an FPA which is included in the docket for today's final rule. A draft version of the FPA was the subject of a Notice of Availability published in the Federal Register on September 1, 2000 in which EPA solicited comment. The FPA was signed on September 22, 2000 by representatives of EPA, the Pennsylvania Department of Environmental Protection (PADEP), and Ortho-McNeil Pharmaceutical. The exemption from the regulatory definition of hazardous waste of the mixed wastes generated at the OMP Spring House facility will remain in effect only for the five-year term of this XL project, and begins upon the effective date of this final rule.

This final rule will apply only to the OMP Spring House facility. Thus, mixed wastes generated in other pharmaceutical research and development facilities remain subject to current Resource Conservation and Recovery Act (RCRA) Subtitle C regulations. (The Agency notes that the term “RCRA Subtitle C regulations” includes the exemptions and exclusions specific to mixed wastes that have been promulgated as part of the regulatory program.) Further, the regulatory modification will only affect the mixed waste that is the focus of this XL project; hazardous wastes resulting from any other operations at the OMP Spring House facility are not affected by today's final rule.

The OMP Spring House facility does not believe the RCRA Subtitle C regulatory controls, as applied to the low-level mixed wastes (LLMW) it generates and treats, provide any additional environmental protection than is otherwise provided by the Atomic Energy Act (AEA) oversight, and indeed believes that RCRA Subtitle C regulatory controls serve as a major disincentive to environmentally protective on-site treatment of the small volume of mixed wastes generated at the facility.

While limited commercial off-site treatment for such wastes is available, the on-site, bench-scale, high-temperature catalytic oxidation unit OMP Spring House will use to treat the mixed wastes has been demonstrated to be more efficient in preventing the emission of radioactivity to the atmosphere and at least as efficient, if not more, at destroying the organic components than available commercial treatment. (The on-site treatment of OMP Spring House's mixed wastes has been tested under a “treatability study” exemption provided in 40 CFR 261.4(f), and granted by PADEP.) According to OMP Spring House, it has not sought a RCRA hazardous waste treatment permit for the catalytic oxidation unit because the costs of permitting cannot be justified from a business standpoint for the small volume of LLMW generated. Nor does OMP Spring House intend to become a commercial mixed waste treatment facility, receiving mixed wastes from off-site facilities which might enable it to recover the costs of a RCRA permit. Finally, OMP Spring House has asserted (as have many of those who commented on EPA's July, 2001 proposed rule) that the costs of existing off-site commercial treatment for the small volume of mixed wastes typically generated in the pharmaceutical research industry are very high and therefore hinder the research and development of new pharmaceuticals.

Mixed waste comprises radioactive hazardous waste, subject to two statutory authorities: (1) The RCRA as implemented by EPA (or States authorized by EPA) with jurisdiction over the hazardous waste component; and (2) the AEA as implemented by either the Department of Energy (DOE), or the Nuclear Regulatory Commission (NRC) (or its Agreement States) with jurisdiction over the radioactive component of the waste. Therefore, absent today's regulatory modification, the management of the mixed wastes that are the subject of this XL pilot project would continue to be subject to both RCRA permitting and NRC licensing requirements and regulatory oversight from the point the waste is generated through to its final disposal.

Members of the regulated community have raised concerns that this dual regulatory oversight of LLMW is unduly burdensome, duplicative and costly, without providing any additional protection of human health and the environment beyond that achieved under one regulatory regime. In response to these concerns, on April 30, 2001, EPA Administrator Christine Todd Whitman signed a final mixed waste rule modifying the existing regulatory framework to provide flexibility related to the storage, treatment (of certain types), transportation and disposal for LLMW (see 66 FR 27217, May 16, 2001). This rule became effective on November 13, 2001 (“Mixed Waste Rule”).

In developing the Mixed Waste Rule, EPA assessed NRC regulations for storage, treatment, transportation and disposal of low-level wastes (LLW) and compared them with EPA's regulations for hazardous waste storage, treatment, transportation and disposal applicable to LLMW. The Agency found that given NRC's regulatory controls, protection of human health and the environment from chemical risks would not be compromised by deferral to NRC's LLW management requirements under the circumstances set forth in the Mixed Waste Rule. Accordingly, through the Mixed Waste Rule, the Agency adopted a conditional exemption from certain RCRA hazardous waste management requirements for NRC-licensed generators of LLMW, in specified circumstances.

Basically, the Mixed Waste Rule allows generators of LLMW to claim a conditional exemption from the RCRA regulatory definition of hazardous waste for mixed wastes stored, treated, transported or disposed of under the NRC regulatory regime, acknowledging the protectiveness of NRC regulations for LLW (of which LLMW is a part). (For the complete text of the Mixed Waste Rule, see 66 FR 27217, May, 16, 2001.) More specifically, the conditional exemption allows, among other things, a generator to treat LLMW generated under a single NRC or NRC Agreement State license, in tanks or containers, without having to obtain a RCRA treatment permit, provided the form of treatment is allowed under its NRC or NRC Agreement State license. The conditional exemption for storage and treatment is only available to generators of LLMW that are licensed by the NRC or NRC Agreement States. In addition, the Mixed Waste Rule provides that LLMW that meets the applicable Land Disposal Restrictions (LDR) standards (either as generated or through treatment) may be transported and disposed of as LLW at an NRC or NRC Agreement State licensed low-level radioactive waste disposal facility (LLRWDF), which need not also possess a RCRA treatment, storage, or disposal permit.

OMP Spring House conducts research and development of pharmaceuticals/drugs at its Spring House, Pennsylvania facility. As part of this work, OMP Spring House develops and utilizes radiolabeled compounds to study the bioabsorption and metabolism of the drugs, in compliance with Food and Drug Administration (FDA) requirements. The radiolabeled compounds typically consist of an isotopically-labeled organic compound and a solvent (the specific solvent varies with the research being conducted). The solvent is mixed with a radioisotope (typically carbon-14 ( 14 C) or tritium ( 3 H)), yielding both the desired radiolabeled compound, and a waste mixture that consists of radioactive materials (over which NRC has jurisdiction) and a hazardous organic component (over which EPA has jurisdiction). This radioactive/hazardous organic waste mixture is the LLMW that is the focus of this XL pilot project. The estimated volume of mixed waste produced per batch by OMP Spring House ranges from less than 50 milliliters to several liters, with an annual total volume of less than 50 liters.

OMP Spring House has developed an innovative bench-scale treatment process (using high-temperature catalytic oxidization), which oxidizes the mixed waste, thereby destroying its hazardous waste components (yielding water and CO 2 ) and capturing the radioactivity in the aqueous residuals or as radioactive CO 2 . In this process the liquid LLMW is completely reacted with oxygen or air at high temperature in the presence of an oxidation catalyst. [For a general physical description of the bench-scale high-temperature catalytic oxidizing unit and how it operates, the reader is referred to the July 24, 2001 proposed rule (see 66 FR at 38399). For a more complete technical description of the unit, operations parameters and analytical methodology, the reader is referred to the document titled “A Prototype High-Temperature Catalytic Oxidation Process For Mixed Waste In A Pharmaceutical Research Laboratory,” available in the docket for today's final rule under Docket ID No. RCRA-2001-0021.]

OMP Spring House's treatment of carbon-14 labeled compounds generates radioactive CO 2 (which is subsequently converted to potassium carbonate) and the treatment of tritium labeled compounds generates radioactive (i.e., tritiated) water ( 3 H). These residual low-level wastes could then be sent off-site for stabilization, recycling, or disposal under NRC or NRC Agreement State regulation. [The Agency notes that because the treatment process yields one of two residuals from a variety of LLMW, they are more amenable to recycling ( e.g., recovery of tritium). However, recycling the small volumes of residuals being generated at the OMP Spring House facility is not currently economically viable. OMP Spring House has been working to support efforts to facilitate the recovery of radioactivity from residuals like those it generates in its high-temperature catalytic oxidization process.] For tritium containing compounds, the volume of the treatment residual is generally the same volume as the wastestream being treated. For carbon-14 containing compounds, the volume of the treatment residuals is generally slightly higher than the volume of the original wastestream being treated. The yearly estimated volume of the treatment residuals generated by the high-temperature catalytic oxidation of LLMW at OMP Spring House is 50 liters per year, which is about the same as the volume of the original LLMW.

OMP Spring House has been operating this innovative catalytic oxidation process for the treatment of the mixed wastes it generates since 1996 under a “treatability study exemption” approved by the PADEP, which is authorized to carry out portions of the RCRA hazardous waste program in Pennsylvania. This treatability study has been conducted to evaluate the performance of the catalytic oxidation process on the organic component of these mixed wastes and the capture of the radioactive components.

The treatment technology being employed by OMP Spring House is not included under the 2001 Mixed Waste Rule because it is not conducted within a “tank” or “container,” as those terms are defined in RCRA. The Agency determined that more specific controls (as are presently provided under RCRA) are generally more appropriate for certain forms of treatment, such as thermal treatment (including incineration) which take place outside of a “tank” or “container,” due to the complexity and variety of such processes and the specificity of RCRA requirements. This XL pilot project affords the Agency an opportunity to test whether a defined subset of LLMW (e.g., small volumes of research and development laboratory-generated mixed wastes being treated within the NRC-licensed laboratory in which the wastes are generated) may safely be treated outside of a tank or container (e.g., use of a bench-scale high temperature catalytic oxidation process) without RCRA regulatory controls (i.e., a treatment permit pursuant to Subtitle C of RCRA), instead relying on AEA regulations implemented by the NRC. Thus, this pilot project is intended to assess the appropriateness of the dual oversight (i.e., concurrent RCRA and AEA regulatory controls) exerted over the small volumes of mixed wastes generated and treated at this pharmaceutical research and development facility, and to characterize those factors that could inform EPA's decision whether mixed wastes generated and treated in similar circumstances should also be exempted from the regulatory definition of hazardous wastes (and thus, RCRA regulatory control) on a national basis (in effect, deferring regulatory oversight of these specific types of mixed wastes to NRC or NRC Agreement States). The pilot project will also provide the Agency additional data regarding the performance of the on-site, bench-scale high-temperature catalytic oxidation unit used to treat the mixed wastes, which will also be considered as part of any future determination regarding possible changes to the types of units included in RCRA's May 2001 Mixed Waste Rule.

To date, OMP Spring House's treatability study has yielded extremely positive results, demonstrating that the full range of organics used to produce radiolabeled compounds are effectively eliminated (routinely achieving destruction and removal efficiencies (DRE) of 99.999% to 99.99999%) by the high-temperature catalytic oxidation process. The treatment process exceeds Land Disposal Restricitons (LDR) treatment standards for organics, and releases only negligible amounts of radioactivity 1 1.

The catalytic oxidation unit is housed in a laboratory fume hood within OMP Spring House's radiosynthesis laboratory suite. All seven fume hoods in the lab suite are connected to a dedicated stack for air emissions. This air pollution control system employs high efficiency particulate arresting (HEPA) filtration to capture any fugitive dusts or particulate matter. No other pharmaceutical research operations, or other processes performed at the facility are tied into this system. Air emissions monitoring for radioactivity is performed whenever the process is operating. The monitoring is of the consolidated non-turbulent air stream within the ventilation system after the juncture of the seven hoods and prior to emissions into the atmosphere via the dedicated stack.

OMP Spring House originally proposed that EPA address its LLMW in one of three ways:

Under each of these alternatives, OMP Spring House noted that the laboratory in which the wastes are generated and treated would continue to be subject to an NRC license, which it believed would be sufficient to protect human health and the environment during the generation and treatment of its LLMW, especially considering the very small volumes of wastes being generated and treated, the small size of the treatment unit, the proximity of the treatment unit to the point of generation (the wastes are both generated and treated within the same laboratory room), the sophisticated level of expertise of the technicians that work in the lab, and the protective controls ( e.g. , emission limits) required by the NRC license.

EPA and the PADEP agreed that applicability of OMP Spring House's NRC license conditions was likely sufficient to ensure that OMP Spring House's high-temperature catalytic oxidation would be operated so as to be protective of human health and the environment absent RCRA regulatory controls, and EPA determined that the most appropriate mechanism to confirm this was by exempting OMP Spring House's LLMW from RCRA's definition of hazardous waste, as discussed below.

To allow for this XL project to be implemented, the Agency proposed on July 24, 2001 to provide a site-specific exemption in 40 CFR 261.4(b) ( i.e. , “Solid wastes which are not hazardous wastes”) for the mixed wastes generated and treated in OMP Spring House's pharmaceutical research and development (R&D) laboratory (see 66 FR 38396). The Agency is today finalizing this site-specific rule, albeit clarifying that it comprises an exemption to RCRA's definition of hazardous waste, not an exclusion to RCRA's definition of solid waste. 2 The effect of this exemption, assuming all the conditions are met, is to remove these wastes from RCRA Subtitle C regulation at the point of their generation. Further, because the residuals resulting from the catalytic oxidation treatment process will not be derived from hazardous wastes, no “delisting” is required for these residuals (since the original wastestream will no longer comprise a RCRA “listed” waste). The Agency believes that this regulatory mechanism is the most efficient way to provide OMP Spring House with the regulatory outcome it seeks and implement the XL pilot project.

The site-specific exemption being finalized today is conditioned on various reporting requirements intended to provide the Agency with the data necessary to determine whether this XL pilot project is a success and obtain the information to help it decide whether the regulatory change should be “transferred” to the national program (which, if it occurs, would happen through normal rulemaking procedures). The specific conditions are further discussed in section III.I.

The Agency agrees with OMP Spring House that this XL project has merit and has the potential to result in significant environmental and efficiency benefits should the regulatory change be adopted on a national basis. While the Agency adopted the Mixed Waste Rule to generically address the regulation of some mixed wastes, Project XL offers the Agency the opportunity to test alternative approaches, in this case, an alternative approach tailored to a specific subset of the generic category of mixed wastes not covered by the Mixed Waste Rule. The Agency believes this is the type of “test” that Project XL is intended to facilitate. The information and data gathered throughout the course of this XL project will provide the Agency with the ability to make a more informed determination regarding the appropriate regulatory controls for “mixed waste” generally, as well as certain discrete subsets of “mixed waste” that may be amenable to an alternative regulatory approach.

During the developmental stages of this XL pilot project, OMP Spring House cultivated stakeholder involvement from the local community and local environmental groups in a variety of ways. These methods included communicating through the local news media, announcements at Township meetings, public meetings and direct contact with interested parties. For a more detailed description of the methods used to involve stakeholders and the meetings held with the local community to discuss the pilot project, the reader is referred to the July 24, 2001 proposed rulemaking (see 66 FR at 38401).

OMP Spring House understands that stakeholder involvement is an integral part of the XL process and will continue to hold public meetings with the local community to provide updates and information on this XL pilot project, as needed.

The Agency received 65 comments in response to the July 24, 2001 proposed rule. Detailed responses to all of these comments is presented in the document titled “Response to Comments on the OMP Spring House XL Project NPRM” contained in the docket for today's final rulemaking under Docket ID No. RCRA-2001-0021. The vast majority of these comments were very supportive and generally encouraged the Agency to move quickly to consider similar regulatory flexibility on a national scale. However, two commenters submitted adverse comments, and several commenters provided editorial suggestions and requests for clarification.

The two commenters which opposed the proposed rule were both commercial LLMW treatment facilities, capable of treating OMP Spring House's's LLMW. (EPA does note that several other treatment facilities offered comments that were supportive of the proposal.) These two commenters questioned the merits of reducing regulatory oversight for such wastes (with the potential for increased risks); the impact of such an exemption on the existing commercial mixed waste treatment industry (which has invested substantial resources to obtain the necessary permits and licenses), and, (if the regulatory flexibility is adopted on a national scale for research and development laboratories) the advisability of having many facilities generating radioactive residuals (even if they are small in volume and recyclable) rather than a small number of commercial facilities generating such residuals (albeit in larger quantities).

The Agency has considered the concerns expressed by these commenters; however, it believes this pilot project should go forward. The Agency believes that the NRC license provides sufficient protections, at least in this specific situation, such that a RCRA permit is not necessary. Thus, we disagree with the commenter who argues that the facility would be “unlicensed/unpermitted.” We also disagree with the commenter who suggested that this rulemaking would reduce the treatment standards for this waste. As has been demonstrated, the high-temperature catalytic oxidation unit utilized by OMP Spring House meets or exceeds the existing treatment standards that these wastes are subject to. Thus, we believe that the rule will not pose additional risks to workers or the public. Moreover, the Agency notes that since OMP Spring House's waste stream will remain a solid waste under RCRA, it retains the authority to require OMP Spring House to address any threat which it determines presents an imminent threat to the public health or the environment. See 42 U.S.C. 6973(a). Further, a core goal of EPA's XL initiative is to promote innovation, which includes considering whether new approaches are better able to protect the public health and the environment than existing regulatory requirements, even where the latter are long-established and required significant investment by facilities to comply. Therefore, while EPA understands the concerns expressed by these commercial mixed waste treatment facilities, the Agency does not believe that these concerns are sufficient to preclude the exploration of other approaches or, in this specific case, testing the proposition that an NRC license provides sufficient protections for the thermal treatment of small volumes of research and development LLMW in the same laboratory where the wastes are generated. (The Agency notes that these commenters did not suggest any specific RCRA regulatory requirement that they thought is necessary to protect human health and the environment at OMP Spring House's NRC-licensed facility.)

OMP Spring House has stated that if it became required to obtain a RCRA permit to operate its catalytic oxidation unit, it would instead send its small volume of mixed wastes generated to a commercial treatment facility. 3 For mixed wastes, commercial treatment costs are typically based primarily upon the level of radioactivity ( i.e. , number of curies) being treated, as well as the volume of the waste. The costs range from approximately $20,000-$35,000 per curie, with an average cost of $30,000/curie. This represents a $300,000/year cost for OMP Spring House, which generates up to 10 curies of mixed waste per year. OMP Spring House has stated that other cost savings, such as reduced transportation costs and administrative/paperwork savings resulting from no longer having its LLMW be defined as a RCRA hazardous waste, are relatively minor compared with the costs of commercial LLMW treatment.

EPA understands that pharmaceutical, medical, and academic research activities, such as the radiolabeling which generates OMP Spring House's mixed wastes, are often limited by the high costs of waste management. Because waste management costs are such a major factor in the budgets allocated to such R&D activities, the high cost of waste management can significantly reduce the money actually spent on R&D. With more cost-effective treatment (such as OMP Spring House's on-site bench-scale catalytic oxidation unit), more money could be spent on the actual research and development of pharmaceuticals.

To implement this XL pilot project, EPA is today modifying 40 CFR 261.4(b) by providing a site-specific exemption from the regulatory definition of hazardous waste for OMP Spring House's LLMW generated and treated in their radiosynthesis laboratory, which is subject to a “Type A Broad Scope” NRC license for research and development. In accordance with 25 Pa. Code section 261a.1 of Pennsylvania's RCRA-authorized hazardous waste program, EPA's exemption of OMP Spring House's mixed waste from the regulatory definition of hazardous waste under RCRA is automatically incorporated in Pennsylvania's hazardous waste regulations because the State hazardous waste regulations incorporate 40 CFR 261.4(b) by reference, including any modification or additions made to that section by the Federal program.

Through the development of the Final Project Agreement (FPA), OMP Spring House had agreed to comply with several conditions for this exemption, which were included in the regulatory text that was proposed on July 24, 2001 and are being finalized today. These conditions focus on demonstrating the efficacy of the treatment technology, and to gather the data and other information that will allow the Agency to make a determination regarding the possible future adoption of this site- specific exemption as a nationwide generic exemption.

The site-specific exemption is limited to a total volume of 50 liters/year of mixed waste and only applies to mixed wastes that are generated and treated using OMP Spring House's high-temperature catalytic oxidation process within the OMP Spring House facility's radiosynthesis laboratory. In addition, the exemption is further conditioned such that OMP Spring House must report, on a semi-annual basis, the following:

(1) Analysis demonstrating the destruction and removal efficiencies for all organic components of the exempted wastes subject to treatment.

(2) Analysis demonstrating the capture efficiencies for the radioactive component of the exempted wastes subject to treatment, and an estimate of the amount of radioactivity that was released during the reporting period.

(3) Analyses of the constituent concentrations, including inorganic constituents, present and radioactivity of the exempted wastes prior to, and after, treatment.

(4) The volume of exempted wastes treated per batch, as well as a total for the duration of the reporting period.

(5) The final disposition of the radioactive residuals from the treatment of the exempted wastes.

In addition, OMP Spring House commits to work with other companies, organizations and research institutes to: (1) Further develop a standard, bench-scale off-the-shelf treatment unit, based on its high-temperature catalytic oxidation technology, to be made available to any company or institution that generates similar R&D quantities of mixed wastes, and (2) further develop the technology and market for the recycling and reuse of the radioactive component of the LLMW ( i.e. , the LLW residuals resulting from the treatment of the LLMW).

As part of meeting this commitment, OMP Spring House will prepare (and submit to EPA for review and comment) a proposed plan summarizing how it will accomplish this goal. Because these two commitments involve the participation of other companies and entities outside OMP Spring House's control and thus are much less certain than the conditions discussed above, these commitments have not been made conditions of the exemption. However, in evaluating the success of this XL project, these “non-enforceable” commitments will be considered by EPA and the PADEP.

This project will be in effect for five years from the date that this final rulemaking becomes effective, unless it is terminated earlier or extended by all project signatories (if the FPA and rule are extended, this will be done through a rulemaking seeking the comments and input of stakeholders and the public). Any project signatory may terminate its participation in this project at any time in accordance with the procedures set forth in the FPA. The project will be completed at the conclusion of the five-year anniversary of today's final rulemaking or at a time earlier or later as agreed to by the parties involved.

Under section 3006 of RCRA, EPA may authorize qualified States to administer and enforce the RCRA program for hazardous waste within the State. (See 40 CFR Part 271 for the standards and requirements for authorization.) States with final authorization administer their own hazardous waste programs in lieu of the Federal program. Following authorization, a state continues to have enforcement responsibility under its State law to pursue violations of its hazardous waste program. EPA continues to have independent enforcement authority under sections 3007, 3008, 3013 and 7003 of RCRA.

After authorization, Federal rules issued under RCRA provisions that predate the Hazardous and Solid Waste Amendments of 1984 (HSWA), no longer apply in the authorized state. New Federal requirements imposed by non-HSWA rules do not take effect in an authorized State until the State adopts the requirements as State law.

In contrast, under section 3006(g) of RCRA, new requirements and prohibitions imposed by HSWA take effect in authorized States at the same time they take effect in nonauthorized States. EPA is directed to carry out HSWA requirements and prohibitions in authorized States until the State is granted authorization to do so.

Today's final rule is promulgated pursuant to non-HSWA authority. Pennsylvania initially received authority from EPA to implement its base hazardous waste program effective January 30, 1986 (see 51 FR 1791, January 15, 1986). Because EPA clarified that the hazardous waste component of mixed waste was subject to RCRA after Pennsylvania received its initial RCRA base authorization (see 51 FR 24504, July 3, 1986), mixed waste was not initially included within Pennsylvania's authorized base program. Pennsylvania subsequently applied to EPA, seeking approval that its hazardous waste program, as revised (including its adoption of regulations governing mixed waste), complied with RCRA. Under the terms of the Commonwealth's hazardous waste program, subsequent modifications and additions to EPA's RCRA regulations as published in the Code of Federal Regulations (with certain exceptions not relevant here) are automatically incorporated into the Commonwealth's hazardous waste program. See 29 Pa. Bull. 2367, 2370 (May 1, 1999), 65 FR at 57734 and 57736 (September 26, 2000).

On September 26, 2000, EPA published notice of Final Authorization of Pennsylvania's hazardous waste program, including specifically its regulation of mixed waste, effective November 27, 2000. See 65 FR 57734 and 57736 (September 26, 2000). EPA did not receive any adverse comments, and thus EPA's authorization of Pennsylvania's hazardous waste program (including mixed wastes) became effective on November 27, 2000.

This XL project was undertaken and developed (by EPA, PADEP, and OMP Spring House) with the assumption that Pennsylvania would receive authorization for mixed wastes, necessitating the regulatory flexibility on the part of PADEP to implement the XL project. Since Pennsylvania has had RCRA authorization for mixed wastes since November 27, 2000, and because Pennsylvania's definition of hazardous waste under the Pennsylvania Solid Waste Management Act (PaSWMA), including its exclusions and exemptions, incorporates RCRA's analogous provisions upon their promulgation, this rule will have the effect of exempting OMP Spring House's mixed wastes from regulation by the Commonwealth as a hazardous waste under its hazardous waste program, which in turn allows Pennsylvania to implement this XL project.

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

Because this rule affects only one facility, it is not a rule of general applicability and therefore is not subject to OMB review and Executive Order 12866.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , since it applies to only one facility. It is exempt from OMB review under the Paperwork Reduction Act because it is a site-specific rule, directed to fewer than ten persons. 44 U.S.C. 3502(3), (10); 5 CFR 1320.3(c), 1320.4 and 1320.5.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. , as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an Agency is required to publish a notice for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e. , small businesses, small organizations, and small governmental jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. This rule will not have a significant impact on a substantial number of small entities because it only affects the OMP Spring House facility, and it is not a small entity.

Based on the foregoing discussion, I hereby certify that this rule will not have a significant adverse economic impact on a substantial number of small entities. Consequently, the Agency has determined that preparation of a formal Regulatory Flexibility Analysis is unnecessary.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “federal mandates” that may result in expenditures by state, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year.

Before promulgating a rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enable officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

As noted above, this rule is applicable only to one facility in Pennsylvania. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. EPA has also determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government.”

This rule does not have federalism implications. It will not have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of powers and responsibilities among the various levels of government, as specified in Executive Order 13132. Today's rule will only affect one facility, providing regulatory flexibility applicable to this specific site. Thus, Executive Order 13132 does 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. EPA is currently unaware of any Indian tribes located in the vicinity of the facility. Thus, Executive Order 13175 does not apply to this rule.

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

This rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866, and because the Agency believes that the environmental health or safety risks addressed by this action do not present a disproportionate risk to children.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It will not result in increased energy prices, increased cost of energy distribution, or an increased dependence on foreign supplies of energy.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA,” Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. Today's rule does not establish technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (February 11, 1994) is designed to address the environmental and human health conditions of minority and low-income populations. EPA is committed to addressing environmental justice concerns and has assumed a leadership role in environmental justice initiatives to enhance environmental quality for all citizens of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, income, or net worth bears disproportionately high and adverse human health and environmental impacts as a result of EPA's policies, programs, and activities.

Today's rule applies to one facility in Pennsylvania. Overall, no disproportional impacts to minority or low income communities are expected.

Today's rule applies to one facility in Pennsylvania. Overall, no disproportional impacts to minority or low income communities are expected.

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

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. Section 804 exempts from section 801 the following types of rules (1) rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability.