The NRCS invites interested persons to submit written comments, data(s), or views. The most helpful comments reference a specific portion of the revisions, explain the reason for any recommended further changes, and include supporting data. We ask that you send us two copies of written comments.

We will file all comments we receive in the docket, as well as a report summarizing each substantive public comment with NRCS personnel concerning this interim final rulemaking. The docket, including any personal information you provide, is made available for public inspection.

We will consider all comments we receive on or before the closing date for comments when we review the final rule's implementation and determine whether further action on these sections is necessary. We will consider comments filed late if it is possible to do so without incurring expense or delay.

You can get an electronic copy of the full Compliance with NEPA rule using the Internet through the NRCS homepage, at http://www.nrcs.usda.gov, and by selecting “Programs,” then “National Environmental Policy Act (NEPA) Documents.”

The rule will better align the NRCS' NEPA regulations with that of the CEQ's regulations that implement the NEPA. The rule amends 7 CFR 650.5(c) Figure 1 by inserting “Program EA” to the flow chart on NRCS decision-making and the rule adds a section to 7 CFR 650.8(a), which discusses the criteria for determining the need for a program EA. The rule also makes changes to 7 CFR 650.12 so that 650.12 better conforms to CEQ's similar regulations.

First, the rule amends 7 CFR 650.5(c) Figure 1 by inserting “Program EA” to the flow chart on NRCS decision-making and by adding a section to 7 CFR 650.8 discussing the criteria for determining the need for a program EA. Previously, Agency regulations did not address NRCS' ability to tier to Program EAs or clarify when it is appropriate to use a program environmental assessment. The change to Figure 1 explicitly confirms the State and field offices' ability to tier site specific environmental reviews and decision-making to either a Program EA or Program EIS. The change to section 650.8 clearly states when it is appropriate to use an environmental assessment. This change aligns NRCS' NEPA regulations with 40 CFR 1507.3(b)(2), which states that Agency NEPA regulations should identify specific criteria for and those classes of action which normally require EA but not EIS. For rulemaking actions under the Farm Bill, the Agency has prepared program EAs in the past because the limited significance of the actions did not warrant the preparation of an EIS. Therefore, this rule change provides for the efficient and timely environmental review of NRCS actions.

Second, NRCS is changing the current requirement of publication of the notice of availability for every EA/FNSI in the Federal Register . CEQ regulations require public involvement in preparing any EA/Finding of No Significant Impact (FNSI) and require a 30 day review period of the EA/FNSI only in the following limited circumstances: (a) The action is, or closely similar to, one which normally requires the preparation of an EIS, as defined by NRCS NEPA implementing regulations at 7 CFR 650.7, or (b) the nature of the action is one without precedent. The revised interim final rule in 7 CFR 650.12 will change NRCS regulations to mirror CEQ's regulations. This will provide the Agency with the flexibility for all program actions to determine the most appropriate method of public involvement in preparing the EA/FNSI and the most appropriate method for publication of the notice of the availability of the EA/FNSI. As noted by CEQ regulations implementing NEPA (40 CFR 1506.6), actions primarily of local concern may be published in local newspapers and use other means to reach the interested and affected members of the public.

The rule will also allow the Agency to implement an action upon issuing the notice of availability of the EA/FNSI or at a specified time period after issuance of the notice based on the public involvement provided. For Agency actions with statutorily short rulemaking timeframes or for emergency actions, the ability to tailor public involvement and review allows the Agency to implement the action upon issuance of the notice of availability or a shorter time frame thereafter while still meeting the requirements of NEPA as well as its intent. This enables the Agency to prepare adequate NEPA analyses and to proceed with timely implementation for these important actions.

The NRCS reviewed this interim final rule under U.S. Department of Agriculture (Department) procedures and Executive Order 12866 issued September 30, 1993 (E.O. 12866), as amended by E.O. 13422 on Regulatory Planning and Review. This interim final is issued in accordance with the E.O. 12866. It has been determined that this interim final is not significant and, therefore, it has not been reviewed by the OMB.

It has been determined that the Regulatory Flexibility Act is not applicable to this rule because NRCS is not required by 5 U.S.C. 553 or any other provision of law to publish a notice of interim final rulemaking with respect to the subject matter of this rule.

The interim final rule amends the procedures for implementing the National Environmental Policy Act (NEPA) at 7 CFR part 650 and would not directly impact the environment. Agency NEPA procedures are procedural guidance to assist agencies in the fulfillment of agency responsibilities under NEPA, but are not the agency's final determination of what level of NEPA analysis is required for a particular action. The CEQ set forth the requirements for establishing agency NEPA procedures in its regulations at 40 CFR 1505.1 and 1507.3. The CEQ regulations do not require agencies to conduct NEPA analyses or prepare NEPA documentation when establishing their NEPA procedures. The determination that establishing agency NEPA procedures does not require NEPA analysis and documentation has been upheld in Heartwood, Inc. v. U.S. Forest Service , 230 F.3d 947, 954-55 (7th Cir. 2000).

There are no requirements for information collection associated with this interim final that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), NRCS has assessed the effects of this interim final on State, local, and Tribal governments and the private sector. This interim final does not compel the expenditure of $100 million or more by any State, local, or Tribal governments or anyone in the private sector. Therefore, a statement under section 202 of the Act is not required.

This interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. After adoption of this interim final, (1) all State and local laws and regulations that conflict with this rule or that would impede full implementation of this rule will be preempted; (2) no retroactive effect would be given to this interim final; and (3) before an action may be brought in a Federal court of competent jurisdiction, the administrative appeal rights afforded persons at 7 CFR parts 614, 780, and 11 must be exhausted.

NRCS has considered this interim final rule under the requirements of Executive Order 13132 issued August 4, 1999 (E.O. 13132), “Federalism.” The Agency has made an assessment that the interim final rule conforms with the Federalism principles set out in this Executive Order; would not impose any compliance costs on the States; and would not have substantial direct effects on the States, on the relationship between the national government and the States, nor on the distribution of power and responsibilities among the various levels of government. Therefore, NRCS concludes that this interim final rule does not have Federalism implications.

This interim final rule has been reviewed under Executive Order 13211 issued May 18, 2001 (E.O. 13211), “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” NRCS has determined that this interim final does not constitute a significant energy action as defined in E.O. 13211.

This rule is issued under Marketing Agreement and Order No. 956, both as amended (7 CFR part 956), regulating the handling of Walla Walla sweet onions grown in Southeast Washington and Northeast Oregon, 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, Walla Walla sweet onion handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate, as proposed herein, will be applicable to all assessable Walla Walla sweet onions beginning on January 1, 2008, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

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

This rule increases the assessment rate established for the Committee for the 2008 and subsequent fiscal periods from $0.21 to $0.22 per 50-pound bag or equivalent of Walla Walla sweet onions handled.

The Walla Walla sweet onion 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 Walla Walla sweet onions. 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 1998-1999 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate of $0.21 per 50-pound bag or equivalent that would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon the basis of the Committee's recommendation or other information available to USDA.

On December 11, 2007, the Committee met and unanimously recommended 2008 expenditures of $116,255 and a $0.01 increase in the assessment rate from $0.21 to $0.22 per 50-pound bag or equivalent. In comparison, the budgeted expenditures for the 2007 fiscal period were $139,210.

The increase in the assessment rate is necessary to offset the recent decline in assessments paid by handlers. Assessment receipts have decreased as the production levels of Walla Walla sweet onions have dropped below historical averages—a result of lower total acreage planted and isolated weather-related crop failures. In response to the lower assessment income level, the Committee reduced the total budgeted expenditures from $139,210 in 2007 to $116,255 for 2008, but still found it necessary to increase the assessment rate to adequately fund Committee operations.

The major expenditures recommended by the Committee for the 2008 fiscal year include $62,732 for administration, $5,000 for travel, $44,000 for promotion, and $2,000 for compliance. Budgeted expenses for these items in 2007 were $62,477, $5,000, $63,300, and $1,000, respectively.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Walla Walla sweet onions from the production area. Walla Walla sweet onion shipments are estimated to be 510,250 50-pound bags or equivalents for the 2008 fiscal period, which should provide $112,255 in assessment income. The remaining difference between the anticipated Committee expenses and the anticipated revenue from assessments is expected to come from interest income on reserve funds ($4,000). Funds held in reserve by the Committee (currently $144,953) are not expected to exceed the equivalent of two fiscal periods budgeted expenditures, the maximum permitted by the order.

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

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2008 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 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.

There are approximately 42 producers of Walla Walla sweet onions in the production area and approximately 20 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201)(SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $6,500,000.

The Committee estimates that in 2007, 494,918 50-pound units of Walla Walla sweet onions were marketed at an average FOB price of approximately $19.00 per 50-pound unit. Using that price as a basis, the total industry value at shipping point was approximately $9,400,000. Average receipts per handler were $470,000, which is much less than the threshold the SBA uses to define a small service firm. Average receipts for the 42 producers of Walla Walla sweet onions for last year were approximately $225,000, well within the SBA definition of small agricultural producer. Thus, it can be concluded that most, if not all, handlers and producers of Walla Walla sweet onions may be classified as small entities based on the definition of the SBA.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2008 and subsequent fiscal periods from $0.21 to $0.22 per 50-pound bag or equivalent. The Committee unanimously recommended 2008 expenditures of $116,255 and an assessment rate of $0.22 per 50-pound bag or equivalent. The assessment rate of $0.22 is $0.01 higher than the rate previously established in the order. The quantity of assessable Walla Walla sweet onions for the 2008 year is estimated at 510,250 50-pound bags or equivalents. Thus, the $0.22 rate should provide $112,255 in assessment income and, along with $4,000 in interest income, will be adequate to meet this year's budgeted expenses of $116,255.

The major expenditures recommended by the Committee for the 2008 year include $62,732 for administration, $5,000 for travel, $44,000 for promotion, and $2,000 for compliance. Budgeted expenses for these items in 2007 were $62,477, $5,000, $63,300, and $1,000, respectively.

The recent decline in assessments collected from handlers has necessitated this assessment rate increase. Assessment income has decreased as the production levels of Walla Walla sweet onions have dropped below historical average levels as a result of lower total acreage planted and isolated weather related crop failures. In response to the lower assessment income level, the Committee reduced its total budgeted expenditures from $139,210 in 2007 to $116,255 for 2008, but still found it necessary to increase the assessment rate to adequately fund Committee operations without depleting the Committee's reserve funds.

The Committee reviewed and unanimously recommended 2008 expenditures of $116,255. Prior to arriving at this budget, the Committee considered information from various sources, including the Finance and the Promotion sub-committees. Alternative expenditure levels were discussed at length by all parties. The assessment rate of $0.22 per 50-pound bag or equivalent of assessable Walla Walla sweet onions was then determined by dividing the total recommended budget by the quantity of assessable Walla Walla sweet onions, estimated at 510,250 50-pound units for the 2008 fiscal period. Anticipated assessment revenue is expected to be approximately $4,000 below the budgeted expenses, which the Committee determined to be acceptable. The Committee expects that interest income for the year will compensate for the $4,000 deficit, but is prepared to use reserve funds if necessary.

A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the producer price for Walla Walla sweet onions for the 2008 season could range between $10.00 and $12.00 per 50-pound bag or equivalent. Therefore, the estimated assessment revenue for the 2008 crop year as a percentage of total producer revenue could range between 1.83 and 2.20 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 Walla Walla sweet onion industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the December 11, 2007, 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 Walla Walla sweet onion 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.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

A proposed rule concerning this action was published in the Federal Register on March 14, 2008 (73 FR 13798). Copies of the proposed rule were also mailed or sent via facsimile to all Walla Walla sweet onion handlers. Finally, the proposal was made available through the Internet by USDA and the Office of the Federal Register. A 60-day comment period ending May 13, 2008, was provided for interested persons to respond to the proposal. No comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBusinessGuide . Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

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

Pursuant to 5 U.S.C. 553, it also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because handlers are already receiving 2008 crop Walla Walla sweet onions from producers. The crop year began on January 1, 2008, and the assessment rate applies to all Walla Walla sweet onions received during the 2008 and subsequent seasons. Also, the Committee needs funds to pay its expenses, which are incurred on a continuing basis. Further, handlers are aware of this rule which was recommended at a public meeting. Finally, a 60-day comment period was provided for in the proposed rule.

This rule is issued under Marketing Agreement No. 115 and Marketing Order No. 982, both as amended (7 CFR Part 982), regulating the handling of hazelnuts grown in Oregon and 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.”

USDA is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is intended that this action apply to all merchantable hazelnuts handled during the 2007-2008 marketing year beginning July 1, 2007. This action applies to all 2007-2008 marketing year restricted hazelnuts until they are properly disposed of in accordance with marketing order requirements. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

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

This rule continues in effect free and restricted percentages which allocate the quantity of domestically produced hazelnuts that may be marketed in domestic inshell markets (free) and hazelnuts that must be exported, shelled, or otherwise disposed of by handlers (restricted). The Board met and, after determining that volume regulation would tend to effectuate the declared policy of the Act, developed a marketing policy to be employed for the duration of the 2007-2008 marketing year.

Volume regulation is intended to stabilize the supply of domestic inshell hazelnuts to meet the limited domestic demand for such hazelnuts, with the goal of providing producers with reasonable returns. Based on an estimate of the domestic inshell trade demand and the total supply of domestically produced hazelnuts available for the 2007-2008 marketing year, the Board voted unanimously at their November 15, 2007, meeting to recommend to USDA that the interim final free and restricted percentages for the 2007-2008 marketing year be established at 8.1863 percent and 91.8137 percent, respectively. Additionally, the Board unanimously voted to set the final free and restricted percentages, effective May 1, 2008, at 9.2671 and 90.7329 percent, respectively.

The Board's authority to recommend volume regulation and use computations to determine the allocation of hazelnuts to individual markets is specified in § 982.40 of the order. Under the order's provisions, free and restricted market allocations of hazelnuts are expressed as percentages of the total hazelnut supply subject to regulation. The percentages are derived by dividing the estimated domestic inshell trade demand (computed by formula) by the Board's estimate of the total domestically produced supply of hazelnuts that are expected to be available over the course of the marketing year.

Inshell trade demand, the key component of the marketing policy, is the estimated quantity of inshell hazelnuts necessary to adequately supply the domestic inshell hazelnut market for the duration of the marketing year. The Board determines the domestic inshell trade demand for each year and uses that estimate as the basis for setting the percentage of the available supply of domestically produced hazelnuts that handlers may ship to the domestic inshell market throughout the marketing season. The order specifies that inshell trade demand be computed by averaging the preceding three years' trade acquisitions of inshell hazelnuts, allowing adjustments for abnormal crop or marketing conditions. In addition, the Board may increase the computed inshell trade demand by up to 25 percent, if market conditions warrant an increase.

As required by the order, prior to September 20 of each marketing year, the Board meets to establish its marketing policy for that year. If the Board determines that volume control would tend to effectuate the declared policy of the Act, the Board then follows a procedure, specified by the order, to compute and announce preliminary free and restricted percentages. The preliminary free percentage releases 80 percent of the adjusted inshell trade demand that handlers may ship to the domestic market. The purpose of releasing only 80 percent of the inshell trade demand under the preliminary stage of regulation is to guard against any potential underestimate of crop size. The preliminary free percentage is expressed as a percentage of the total hazelnut supply subject to regulation, where total supply is the sum of the estimated crop production less the three-year average disappearance plus the undeclared carry-in from the previous marketing year.

On August 21, 2007, the National Agricultural Statistics Service (NASS) released an estimate of 2007 hazelnut production for the Oregon and Washington area at 33,000 dry orchard-run tons. NASS uses an objective yield survey method to estimate hazelnut production which has historically been very accurate.

On August 23, 2007, the Board met for the purpose of (1) determining if volume control regulation would tend to effectuate the declared policy of the Act; (2) estimating the total available supply and the domestic inshell trade demand for hazelnuts; (3) establishing preliminary free and restricted marketing percentages for the 2007-2008 marketing year; and (4) authorizing market outlets for restricted hazelnuts.

After discussion, the Board unanimously determined that volume regulation would be necessary to effectively market the industry's 2007 crop and would tend to effectuate the declared policy of the Act. The determination was based on (1) the size of the 2007 hazelnut crop; (2) the inability of the domestic inshell market to absorb such a large crop; (3) the projected large size of the world hazelnut crop and the probability of an oversupplied world market; and (4) the average price paid to Oregon-Washington producers has not exceeded the parity price in any one of the past 18 years.

The Board then estimated the total available supply for the 2007 crop year to be 33,603 tons. The Board arrived at that quantity by using the crop estimate compiled by NASS (33,000 tons) and then adjusting that estimate to account for disappearance and carry-in. The order requires the Board to reduce the crop estimate by the average disappearance over the preceding three years (1,426 tons) and to increase it by the amount of undeclared carry-in from previous years' production (2,029 tons).

In the calculation, disappearance is defined as the difference between the estimated orchard-run production and the actual supply of merchantable product available for sale by handlers. Disappearance can consist of (1) unharvested hazelnuts; (2) culled product (nuts that are delivered to handlers but later discarded); (3) product used on the farm, sold locally, or otherwise disposed of by producers; and (4) statistical error in the orchard-run production estimate.

Undeclared carry-in is defined as hazelnuts that were produced in a previous marketing year but were not subject to regulation because they were not shipped during that marketing year. Undeclared carry-in is subject to regulation during the current marketing year and is accounted for as such by the Board.

Additionally, the Board estimated domestic inshell trade demand for the 2007-2008 marketing year to be 2,478 tons. The Board arrived at this estimate by taking the average of the domestic inshell trade acquisitions for the 2003/2004, 2004/2005, and the 2006/2007 marketing years (2,649 tons), increasing that amount by 5 percent (133 tons) to encourage sales (as allowed by the order), and then reducing that quantity by the declared carry-in from last year's crop (304 tons). The trade acquisition data for the 2005-2006 marketing year was omitted from the Board's calculations, as allowed by the order, after it was determined to be abnormal due to crop and marketing conditions. The Board is also allowed to increase the average domestic inshell trade acquisitions in their calculation by up to 25 percent, if market conditions justify such an increase. At this stage in the establishment of the marketing policy, the Board voted unanimously that a 5 percent increase would be sufficient to encourage new sales without risking oversupply of the market.

The declared carry-in represents product regulated under the order during a preceding marketing year but not shipped during that year. This inventory must be accounted for when estimating the quantity of product to make available to adequately supply the market.

After establishing estimates for total available hazelnut supply and domestic inshell trade demand, the Board used those estimates to compute and announce preliminary free and restricted percentages of 5.8983 percent and 94.1017 percent, respectively. The Board computed the preliminary free percentage by multiplying the adjusted inshell trade demand by 80 percent and dividing the result by the estimate of the total available supply subject to regulation (2,478 tons x 80 percent/33,603 tons = 5.8983 percent). The preliminary free percentage initially released 1,982 tons of hazelnuts from the 2007-2008 supply for domestic inshell use. The Board authorized the preliminary restricted percentage (31,621 tons) to be exported or shelled for the domestic kernel markets.

Under the order, the Board must meet again on or before November 15 to review and revise the preliminary estimate of the total available supply of hazelnuts and to recommend interim final and final free and restricted percentages. As indicated earlier, when establishing preliminary free and restricted percentages, the Board utilizes a pre-harvest objective yield survey, compiled by NASS on behalf of the Board, to estimate the upcoming crop size. After the hazelnut harvest has concluded—usually sometime in October—information is available directly from handlers to more accurately estimate crop size. The Board may use this information to amend their preliminary estimate of total available supply before calculating the interim final and final percentages. At this meeting, the Board may also amend the percentage increase included in the computation of inshell trade demand to encourage increased sales.

Interim final percentages are calculated in the same way as the preliminary percentages but release 100 percent of the inshell trade demand, effectively releasing the additional 20 percent held back at the preliminary stage. Final free and restricted percentages may release up to an additional 15 percent of the average trade acquisitions of inshell hazelnuts for desirable carryout, to provide an adequate carryover of product into the following season. The order requires that final free and restricted percentages be effective 30 days prior to the end of the marketing year, or earlier, if recommended by the Board and approved by USDA. The Board is allowed to combine the interim final and the final stages of the marketing policy, if marketing conditions so warrant, by recommending final percentages which immediately release 100 percent of the inshell trade demand (the preliminary percentage plus the additional 20 held back) plus any percentage increase the Board determines for desirable carryout. Revisions in the marketing policy can be made until February 15 of each marketing year, but the inshell trade demand can only be revised upward, consistent with § 982.40(e).

The Board met, as required by the order, on November 15, 2007, to review and approve an amended marketing policy and to recommend the establishment of interim final and final free and restricted percentages. At that time, the Board revised the crop estimate in the marketing policy to 36,270 tons (from 33,000 tons) after considering the results of post-harvest handler survey information compiled by the Board. The Board also revised the percentage increase meant to encourage sales that is included in the inshell trade demand computation from 5 percent to 25 percent, effectively allocating another 529 tons of inshell hazelnuts that may be marketed in the domestic market.

Using the revised crop estimate and the increased inshell trade demand, the Board then computed interim final free and restricted percentages. The percentages release the remaining 20 percent of the estimated inshell trade demand that was withheld during the preliminary stage of the marketing policy, as well as take into account the amendments made by the Board to the marketing policy computations (revising the total supply estimate and increasing the inshell trade demand). The interim final free and restricted percentages were therefore set at 8.1863 and 91.8137 percent, respectively. The interim final free percentage immediately releases a total of 3007 tons of inshell hazelnuts from the 2007-2008 supply that may be marketed in domestic markets.

During the meeting, the Board decided that market conditions were such that the industry would benefit from the release of an additional 15 percent of the three year average trade acquisitions to allow for desirable carryout and that the increase would not adversely affect the 2007-2008 domestic inshell market. The final free and restricted percentages were set at 9.2671 and 90.7329 percent, respectively. The final percentages are to become effective May 1, 2008. The final free percentage releases 3,404 tons of inshell hazelnuts from the 2007-2008 supply for domestic use, which includes 397 tons released late in the marketing year for desirable carryout.

The final marketing percentages are based on the Board's final production estimate and the following supply and demand information for the 2007-2008 marketing year:

In addition to complying with the provisions of the order, the Board also considered USDA's 1982 “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” (Guidelines) when making its computations in the marketing policy. This volume control regulation provides a method to collectively limit the supply of inshell hazelnuts available for sale in domestic markets. The Guidelines provide that the domestic inshell market has available a quantity equal to 110 percent of prior years' shipments before allocating supplies for the export inshell, export kernel, and domestic kernel markets. This provides for a plentiful supply of inshell hazelnuts for consumers and for market expansion, while retaining the mechanism for dealing with oversupply situations. The established final percentages make available approximately 755 additional tons to encourage increased sales. The total free supply for the 2007-2008 marketing year is estimated to be 3,404 tons of hazelnuts, which is 137 percent of the average of the last three prior years' sales (2,478 tons) and exceeds the goal of the Guidelines.

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

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 having annual receipts of less than $6,500,000. There are approximately 650 producers of hazelnuts in the production area and approximately 19 handlers subject to regulation under the order. Using statistics compiled by NASS, the average value of production received by producers in 2004-2006 was $54,088,000. Using those estimates, the average annual hazelnut revenue per producer would be approximately $83,200. The level of sales of other crops by hazelnut producers is not known. In addition, based on records maintained by the Board, approximately 83 percent of the handlers ship under $6,500,000 worth of hazelnuts on an annual basis. In view of the foregoing, it can be concluded that the majority of hazelnut producers and handlers may be classified as small entities.

Board meetings are widely publicized in advance of the meetings and are held in a location central to the production area. The meetings are open to all industry members and other interested persons who are encouraged to participate in the deliberations and voice their opinions on topics under discussion. Thus, Board recommendations can be considered to represent the interests of small business entities in the industry.

Currently, U.S. hazelnut production is allocated among three main market outlets: Domestic inshell, export inshell, and kernel markets. Handlers and producers receive the highest return for sales in the domestic inshell market. They receive less for product going to export inshell, and the least for kernels. Based on Board records of average shipments for 1997-2006, the percentage going to each of these markets was 10 percent (domestic inshell), 53 percent (export inshell), and 36 percent (kernels). Other minor market outlets make up the remaining 1 percent.

The inshell hazelnut market can be characterized as having limited and inelastic demand with a very short primary marketing period. On average, 80 percent of domestic inshell hazelnut shipments occur between October 1 and November 30, primarily to supply holiday nut demand. The inshell market is, therefore, prone to oversupply and correspondingly low producer prices in the absence of supply restrictions. This volume control regulation provides a method for the U.S. hazelnut industry to limit the supply of domestic inshell hazelnuts available for sale in the continental U.S. and thereby mitigate market oversupply conditions.

Many years of marketing experience led to the development of the current volume control procedures. These procedures have helped the industry solve its marketing problems by keeping inshell supplies in balance with domestic needs. Volume controls ensure that the domestic inshell market is fully supplied while protecting the market from the negative effects of oversupply.

Although the domestic inshell market is a relatively small portion of total hazelnut sales (averaging 10 percent of total shipments for 1997-2006), it remains a profitable market segment. The volume control provisions of the order are designed to avoid oversupplying this particular market segment, because that would likely lead to substantially lower producer prices. The other market segments, export inshell and kernels, are expected to continue to provide good outlets for U.S. hazelnut production into the future.

Adverse climatic conditions that negatively impacted hazelnut production in the other hazelnut producing regions of the world in 2004 and 2005 have corrected and the total world supply in 2007-2008 is predicted to be near the historically high levels seen in 2006. Product prices in the world market have trended downward in the expectation of the large available supply. While the U.S. hazelnut industry continues to experience high demand for their large sized and high quality product, the prices that producers receive are tied to the global market. In light of the anticipated world supply situation, regulation of the domestic inshell market is important to the U.S. hazelnut industry to insulate that specialty market from the supply related challenges of the global hazelnut market.

In Oregon and Washington, lower hazelnut production years typically follow higher production years (a historically consistent cyclical pattern), and such was the case in 2007. The 2006 crop of 43,000 tons was 20 percent above the 10-year average (34,000 tons for 1997-2006) for hazelnut production. The 2007 crop of (36,720 tons, according to the survey of handlers conducted by the Board) is estimated to be 16 percent below the previous year. Using the NASS estimate of 33,000 tons, the crop is 23 percent lower. It is predicted that the 2008 crop will follow the recent production pattern and will be larger than the current crop year. This cyclical trait also leads to an inversely corresponding cyclical price pattern for hazelnuts. The intrinsic cyclical nature of the hazelnut industry lends credibility to the volume control measures enacted by the Board under the marketing order.

Recent production and price data reflect the stabilizing effect of volume control regulations. Industry statistics show that total hazelnut production has varied widely over the 10-year period between 1997 and 2006, from a low of 15,500 tons in 1998 to a high of 49,500 tons in 2001. Production in the smallest crop year and the largest crop year were 48 percent and 145 percent, respectively, of the 10-year average of 34,000 tons. Producer price, however, has not fluctuated to the extent of production. Prices in the lowest price year and the highest price year were 63 percent and 200 percent, respectively, of the 10-year average price of $1,114 per ton. If the extraordinarily high price for the 2005 crop year is excluded as an aberration that stems from a global production crisis, the percentage variation in price drops to 70 percent and 145 percent of a $988 per ton average price, respectively.

The lower level of variability of price versus the variability of production provides an illustration of the order's price-stabilizing impact. The coefficient of variation (a standard statistical measure of variability; “CV”) for hazelnut production over the 10-year period is 0.33. In contrast, the coefficient of variation for hazelnut producer prices, excluding the 2005 price, is only 0.20, dramatically lower than the CV for production. The lower level of variability of price versus the variability of production provides an illustration of the order's price-stabilizing impact.

Comparing producer revenue to cost is useful in highlighting the impact on producers of recent product and price levels. A recent hazelnut production cost study from Oregon State University estimated cost-of-production per acre to be approximately $1,340 for a typical 100-acre hazelnut enterprise. Average producer revenue per bearing acre (based on NASS acreage and value of production data) equaled or exceeded that typical cost level only four times from 1997 to 2006. Average producer revenue was below typical costs in the other years. Without the stabilizing influence of the order, producers may have lost more money. While crop size has fluctuated, volume regulations contribute to orderly marketing and market stability by moderating the variation in returns for all producers and handlers, both large and small.

While the level of benefits of this rulemaking is difficult to quantify, the stabilizing effects of volume regulation impact both small and large handlers positively by helping them maintain and expand markets even though hazelnut supplies fluctuate widely from season to season. This regulation provides equitable allotment of the most profitable market, the domestic inshell market. That market is available to all handlers, regardless of size.

As an alternative to this regulation, the Board discussed not regulating the marketing of the 2007 hazelnut crop. However, without any regulation in effect, the Board believes that the industry would tend to oversupply the inshell domestic market. The 2007 hazelnut crop is smaller than last year's crop but is still 7 percent above the ten-year average. The unregulated release of 36,732 tons on the domestic inshell market could easily oversupply the small, but lucrative domestic inshell market. The Board believes that any oversupply would completely disrupt the market, causing producer returns to decrease dramatically.

Section 982.40 of the order establishes a procedure and computations for the Board to follow in recommending to USDA establishment of preliminary, interim final, and final percentages of hazelnuts to be released to the free and restricted markets each marketing year. The program results in a plentiful supply of hazelnuts for consumers and for market expansion while retaining the mechanism for dealing with oversupply situations.

Hazelnuts produced under the order comprise virtually all of the hazelnuts produced in the U.S. This production represents, on average, less than 3 percent of total U.S. production of all tree nuts, and less than 5 percent of the world's hazelnut production.

Last season, 73 percent of the domestically produced hazelnut kernels were marketed in the domestic market and 27 percent were exported. Domestically produced kernels generally command a higher price in the domestic market than imported kernels. The industry is continuing its efforts to develop and expand other markets with emphasis on the domestic kernel market. Small business entities, both producers and handlers, benefit from the expansion efforts resulting from this program.

Inshell hazelnuts produced under the order compete well in export markets because of their high quality. Based on Board statistics, Europe has historically been the primary export market for U.S. produced inshell hazelnuts. Shipments have also been relatively consistent, not varying much from the 10 year average of 4,906 tons. Recent years, though, have seen a significant increase in export destinations. Last season, inshell shipments to Europe totaled 4,401 tons, representing just 16 percent of exports, with the largest share going to Germany. Inshell shipments to Southwest Pacific countries—Hong Kong in particular—have increased dramatically in the past few years, rising to 79 percent of total inshell exports of 27,259 tons for the 2006-2007 marketing year. The industry continues to pursue export opportunities.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

There are some reporting, recordkeeping, and other compliance requirements under the order. The reporting and recordkeeping burdens are necessary for compliance purposes and for developing statistical data for maintenance of the program. The information collection requirements have been previously approved by the Office of Management and Budget under OMB No. 0581-0178, Vegetable and Specialty Crops. The forms require information which is readily available from handler records and which can be provided without data processing equipment or trained statistical staff. 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. This rule does not change those requirements. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Further, the Board's meetings were widely publicized throughout the hazelnut industry and all interested persons were invited to attend the meetings and participate in Board deliberations. Like all Board meetings, those held on August 23, 2007, and November 15, 2007, were public meetings and all entities, both large and small, were able to express their views on this issue.

An interim final rule concerning this action was published in the Federal Register on February 19, 2008. Copies of the rule were mailed by the Board's staff to all Board members and hazelnut handlers. In addition, the rule was made available through the Internet by USDA and the Office of the Federal Register. That rule provided for a 60-day comment period which ended April 21, 2008. 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/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBusinessGuide. 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 Board and other available information, it is hereby found that finalizing the interim final rule, without change, as published in the Federal Register (73 FR 9000, February 19, 2008) will tend to effectuate the declared policy of the Act.

Background

Title XIII of the Housing and Community Development Act of 1992, Public Law 102-550, titled the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Act) (12 U.S.C. 4501 et seq. ), established OFHEO as an independent office within the Department of Housing and Urban Development to ensure that Fannie Mae and Freddie Mac (collectively the Enterprises) are adequately capitalized, operate safely and soundly, and comply with applicable laws, rules and regulations. The Act provides that the Director of OFHEO (Director) is authorized to make such determinations and take such actions as the Director determines necessary with respect to the issuance of regulations regarding, among other things, the required capital levels for the Enterprises. The Act further provides that the Director shall issue regulations establishing the risk-based capital test (Risk-Based Capital Regulation) and that the Risk-Based Capital Regulation, subject to certain confidentiality provisions, shall be sufficiently specific to permit an individual other than the Director to apply the risk-based capital test in the same manner as the Director.

Pursuant to the Act, OFHEO published a final regulation setting forth a risk-based capital test which forms the basis for determining the risk-based capital requirement for each Enterprise. The Risk-Based Capital Regulation has been amended to incorporate corrective and technical amendments that enhance the transparency sensitivity to risk and accuracy of the calculation of the risk-based capital requirement.

Consistent with the Act and OFHEO's commitment to review, update and enhance the Risk-Based Capital Regulation in order to ensure an accurate risk sensitive and transparent calculation of the risk-based capital requirement, OFHEO published a notice of proposed rulemaking (NPRM) to incorporate amendments to the Risk-Based Capital Regulation. Specifically, OFHEO proposed two changes to the Risk-Based Capital Regulation. The first change was proposed because certain loss severity equations resulted in the Enterprises recording profits instead of losses on foreclosed mortgages during the calculation of the risk-based capital requirement. The current loss severity equations overestimate Enterprise recoveries for defaulted government guaranteed and low loan-to-value loans. The results generated by the current loss severity equations are not consistent with the Risk-Based Capital Regulation and result in significant reductions in the risk-based capital requirements for the Enterprises. The second change relates to the treatment of Federal Housing Administration insurance associated with single-family loans with a loan-to-value ratio below 78%. OFHEO proposed changes related to these loans that would make the Risk-Based Capital Regulation consistent with current law.

The following table shows the estimated capital impact of all of the amendments at September 30 and December 31, 2006.

The amendments substantially increase the RBC Requirement in both the up and down interest rate scenarios for both Enterprises for the two quarters analyzed. However, if the amendments had been in effect during the analyzed periods, total capital would have exceeded the RBC Requirement and the capital classifications of the Enterprises would not have changed.

The 90-day comment period ended March 4, 2008. All comments received have been made available to the public in the OFHEO Public Reading Room and have also been posted on the OFHEO Web site at http://www.OFHEO.gov .

Comments were received from the American Bankers Association (ABA), Fannie Mae, Freddie Mac, the National Association of Homebuilders (NAHB), and the Mortgage Insurance Companies of America (MICA). All comments were taken into consideration. Significant comments related to the proposed regulation are discussed below.

Fannie Mae commented that the proposed amendments fail to recognize properly its experience during times of credit stress. In support of this statement, Fannie Mae presented data on mortgage defaults that occurred between 1992 and 2006 when home prices declined more than 15% between origination and foreclosure. Within this population of loans, Fannie Mae realized a gain on 20% of the loans with an LTV of 60 percent or less and also realized a gain on six percent of the loans with high levels of third party mortgage insurance.

OFHEO does not find that the comment and data presented by Fannie Mae support a change in OFHEO's proposed amendment to the Risk-Based Capital Regulation. While gains on defaults of individual loans are possible and have occurred in the historical data, the risk-based capital stress test simulates the average behavior of groups of similar loans, rather than that of individual loans. From that perspective the data presented by Fannie Mae bolsters the OFHEO proposal to restrict negative losses. The data from Fannie Mae show that 80% of defaulted loans with an LTV below 60 percent result in a loss and 94% of defaulted loans with high levels of mortgage insurance result in a loss. Although Fannie Mae did not provide the average gain or loss for these populations, it is unlikely that there was an average gain, given the small percentages of loans with gains.

Fannie Mae also commented that the proposed amendments, by not fully recognizing the Enterprises' loss mitigation practices, do not provide the proper incentive to the Enterprises to engage in those practices. The ABA and the NAHB also raised concerns that the risk-based capital stress test might not fully recognize the benefits of the Enterprises' loss mitigation practices. OFHEO expects that only rarely, if at all, would the risk-based capital stress test limit the representation of benefits of the Enterprises' loss mitigation practices. This expectation is consistent with the data on loans with high levels of mortgage insurance that Fannie Mae presented in its comment, which showed a gain on only six percent of those loans. OFHEO also acknowledges that the risk-based capital stress test does not capture every detail of the risks and the risk mitigation strategies of the Enterprises, since, of necessity, it is a stylized representation of the financial operations and statements of the Enterprises. As such, the risk-based capital stress test reflects numerous accommodations across the dimensions of accuracy, complexity, transparency, operational workability, and regulatory caution. OFHEO will continue to review the RBC Stress Test Model and will propose enhancements where appropriate. This final amendment is a marked improvement over the prior approach.

Freddie Mac and MICA commented in favor of all of the proposed amendments. In addition to its comments on the proposed amendments, MICA raised additional concerns that were beyond the scope of the current rulemaking. MICA expressed concern that the current Risk-Based Capital Regulation allowed the cross-subsidization of interest-rate and credit risk, thereby allowing the Enterprises to hold an insufficient amount of capital against either risk. MICA also commented that OFHEO should revise the Risk-Based Capital Regulation to apply the regulation on a combined loan-to-value ratio of an Enterprise's position and to develop measures of credit risk that distinguish subprime and non-traditional mortgage structures from less-risky ones. Although these comments are beyond the scope of the current rulemaking, OFHEO nevertheless welcomes MICA's suggestions for possible future rulemaking topics.

OFHEO has taken into consideration all of the comments submitted in connection with this rulemaking, and for the reasons discussed above, OFHEO has determined to issue the amendments as proposed.

The amendments incorporate changes to the loss severity equations used to calculate the risk-based capital requirement as well as changes to the treatment of Federal Housing Administration insurance in the Risk-Based Capital Regulation in order to conform to current law. The amendments to the Risk-Based Capital Regulation are not classified as an economically significant rule under Executive Order 12866 because they do not result in an annual effect on the economy of $100 million or more or a major increase in costs or prices for consumers, individual industries, Federal, state or local government agencies, or geographic regions; or have significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in foreign or domestic markets. Accordingly, no regulatory impact assessment is required. Nevertheless, the amendments were submitted to the Office of Management and Budget (OMB) for review under the provisions of Executive Order 12866 as a significant regulatory action.

Executive Order 13132 requires that Executive departments and agencies identify regulatory actions that have significant federalism implications. A regulation has federalism implications if it has substantial direct effects on the states, on the relationship or distribution of power between the Federal Government and the states, or the distribution of power and responsibilities among various levels of government. The Enterprises are federally chartered entities supervised by OFHEO. The amendments to the Risk-Based Capital Regulation address matters which the Enterprises must comply with for Federal regulatory purposes. The amendments to the Risk-Based Capital Regulation address matters regarding the risk-based capital calculation for the Enterprises and therefore do not affect in any manner the powers and authorities of any state with respect to the Enterprises or alter the distribution of power and responsibilities between Federal and state levels of government. Therefore OFHEO has determined that the amendments to the Risk-Based Capital Regulation have no federalism implications that warrant preparation of a Federalism Assessment in accordance with Executive Order 13132.

The amendments do not contain any information collection requirements that require the approval of OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation does not have a significant economic impact on a substantial number of small entities 5 U.S.C. 605(b). OFHEO has considered the impact of the amendments to the Risk-Based Capital Regulation under the Regulatory Flexibility Act. The General Counsel of OFHEO certifies that the amendments to the Risk-Based Capital Regulation are not likely to have a significant impact on a substantial number of small business entities because the regulation is applicable only to the Enterprises, which are not small entities for the purposes of the Regulatory Flexibility Act.

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

Interested persons are invited to submit such written data, views, or arguments as they may desire. Communications should identify the regulatory docket or special condition number and be submitted in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE288.” The postcard will be date stamped and returned to the commenter.

On October 5, 2005, Embraer S.A. applied for a type certificate for their new Model EMB-500. The Model EMB-500 is a normal category, low-winged monoplane with “T” tailed vertical and horizontal stabilizers, retractable tricycle type landing gear and twin turbofan engines mounted on the aircraft fuselage. Its design characteristics include a predominance of metallic construction. The maximum takeoff weight is 9,965 pounds, the V MO /M MO is 275 KIAS/M 0.70 and maximum altitude is 41,000 feet.

The Embraer S.A. Model EMB-500 airplane is equipped with Pratt & Whitney Canada PW617F turbofan engines using an electronic engine control system instead of a traditional mechanical control system. Even though the engine control system will be certificated as part of the engine, the installation of an engine with an electronic control system requires evaluation due to critical environmental effects and possible effects on or by other airplane systems. For example, indirect effects of lightning, radio interference with other airplane electronic systems, shared engine and airplane data and power sources.

The regulatory requirements in 14 CFR part 23 for evaluating the installation of complex systems, including electronic systems and critical environmental effects, are contained in § 23.1309. However, when § 23.1309 was developed, the use of electronic control systems for engines was not envisioned. Therefore, the § 23.1309 requirements were not applicable to systems certificated as part of the engine (reference § 23.1309(f)(1)). Although the parts of the system that are not certificated with the engine could be evaluated using the criteria of § 23.1309, the integral nature of systems such as these makes it unfeasible to evaluate the airplane portion of the system without including the engine portion of the system.

In some cases, the airplane that the engine is used in will determine a higher classification (Advisory Circular (AC) 23.1309) than the engine controls are certificated for, which will require that the FADEC/DEEC (Digital Electronic Engine Control) systems be analyzed at a higher classification. As of November 2005 FADEC special conditions will mandate the classification for § 23.1309 analysis for loss of FADEC control as catastrophic for any airplane. This is not to imply that an engine failure is classified as catastrophic, but that the digital engine control must provide an equivalent reliability to mechanical engine controls.

Under the provisions of 14 CFR 21.17, Embraer S.A. must show that the Model EMB-500 meets the applicable provisions of 14 CFR part 23, as amended by Amendments 23-1 through 23-55, thereto.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the Model EMB-500 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Model EMB-500 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy pursuant to section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

Special conditions, as appropriate, as defined in 11.19, are issued in accordance with § 11.38, and become part of the type certification basis in accordance with § 21.17(a)(2).

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.

The Embraer S.A. Model EMB-500 will incorporate the following novel or unusual design features: Electronic engine control system.

As discussed above, these special conditions are applicable to the Model EMB-500. Should Embraer S.A. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101.

This action affects only certain novel or unusual design features on one model (Model EMB-500) of airplane. It is not a rule of general applicability, and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the Federal Register ; however, as the certification date for the Embraer S.A. Model EMB-500 is imminent, the FAA finds that good cause exists to make these special conditions effective upon issuance.

1. Electronic Engine Control .

The installation of the electronic engine control system must comply with the requirements of § 23.1309(a) through (e) at Amendment 23-55. The intent of this requirement is not to reevaluate the inherent hardware reliability of the control itself, but rather determine the effects, including environmental effects addressed in § 23.1309(e), on the airplane systems and engine control system when installing the control on the airplane. When appropriate, engine certification data may be used when showing compliance with this requirement; however, the effects of the installation on this data must be addressed.

For these evaluations, the loss of FADEC control will be analyzed utilizing the threat levels associated with a catastrophic failure.

On March 11, 2008, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Cessna Model 208 and 208B airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on March 17, 2008 (73 FR 14191). The NPRM proposed to detect and correct damaged wiring of the auto-control wing de-ice system, fuel quantity indication, and low fuel annunciation systems.

We provided the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and FAA's response to each comment:

The Aircraft Owners and Pilots Association (AOPA) comments that they believe the issuance of an AD on the wiring bundles of the Cessna 208 is premature. The AOPA comments that it believes a service bulletin is an effective way to correct the wiring bundle issues, and FAA should have allowed more time for the service bulletin, dated February 4, 2008, to be distributed to Cessna 208 owners and mechanics. The commenter adds that if after a reasonable amount of time the service bulletin is not appropriately addressing the safety concern, then the FAA could issue a special airworthiness information bulletin (SAIB) or an AD.

We do not concur with the AOPA comment. Mandatory service bulletins and their process thereof do not constitute rulemaking for owners/operators to complete the requested action. The only enforceable process to assure that the unsafe condition is properly addressed on all aircraft is through the rulemaking process, in this case an AD.

We are making no changes to the final rule based on this comment.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 512 airplanes in the U.S. registry.

We estimate the following costs to do the inspection:

We estimate the following costs to do any necessary repairs that would be required based on the results of the inspection. We have no way of determining the number of airplanes that may need this repair/replacement:

Transport Canada (TC), which is the aviation authority for Canada, has issued Airworthiness Directive CF-2008-08R1, dated March 18, 2008, (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

P&WC has issued ASB PW300-72-A24588, Revision 2, dated November 27, 2007. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of Canada, and is approved for operation in the United States. Pursuant to our bilateral agreement with Canada, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all the information provided by Canada and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because fan blades identified by this AD have been found to have an under-minimum material thickness condition which has caused failure and release of fan blades. In one event, the fan blade failure (contained) resulted in high engine vibrations causing the loss of the upper and lower engine cowls. Fan blade failure could result in an engine shutdown and damage to the airplane. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0664; Directorate Identifier 2008-NE-04-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about 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 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 this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on March 28, 2008 (73 FR 16577). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

Several production aircraft have been found with the elevator overload bungees installed in reverse orientation: i.e., larger end outboard rather than inboard. This bungee reversal does not impact normal operation of the elevator, and would not increase the probability of an elevator disconnect. However, if a bungee became disconnected at the inboard side, the corresponding side of the elevator may not center, and this could adversely affect the pitch control of the aircraft.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 38 products of U.S. registry. We also estimate that it will take 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $36 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $4,408, or $116 per product.

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 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 this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We issued a supplemental notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That supplemental NPRM was published in the Federal Register on May 7, 2008 (73 FR 25609). That supplemental NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

ExpressJet requests that we revise two tasks, “28-41-01-720-001-A00 and 28-41-01-720-A00,” specified in Table 1 of the supplemental NPRM. The commenter states that these tasks are related to a functional check of the component rather than the aircraft system. The commenter suggests that we identify these two components by part number and require the inspections be done before the part accumulates 10,000 flight hours since new or 10,000 flight hours since the last functional check.

We agree with the commenter that tasks 28-41-01-720-001-A00 and 28-41-04-720-001-A00 are related to a functional check of the component rather than the aircraft system (the commenter referred to task 28-41-01-720-A00, which is not listed in Table 1; we infer that the commenter intended to refer to task 28-41-04-720-001-A00). Prior to the commenter submitting its comment, the commenter raised the issue during a visit by the FAA. Since then we have discussed the issue with the manufacturer and with the Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil. ANAC states that it intends to issue an airworthiness directive to address an inspection threshold for these tasks. Therefore, we have removed these tasks from Table 1 of this AD. We might consider further rulemaking once new actions and compliance times for these tasks are identified by ANAC or in absence of any new action from ANAC, we might consider unilateral rulemaking.

ExpressJet and EMBRAER request that we extend the compliance times specified in Table 1 of the supplemental NPRM. ExpressJet states that the compliance times for the inspections specified in Table 1 of the supplemental NPRM are confusing. ExpressJet notes that the “Grace Period” is “Within 90 days after the effective date of this AD,” but the effective date of the AD is not stated and the compliance time for revising the ALS of the ICA is before December 16, 2008. ExpressJet recommends that we revise the “Grace Period” to within 90 days after December 16, 2008.

EMBRAER states that the compliance time “within 90 days of the effective date of the AD” for airplanes with cycle totals above the thresholds would require airplanes to be removed from service for special inspections and that these inspections would require the fuel tanks to be drained and ventilated prior to inspection. EMBRAER states that requiring unscheduled tank inspections will increase the probability of maintenance error, which will result in an increase in the risk of ignition sources. EMBRAER believes that there is no special risk that justifies the compliance time of within 90 days from the effective date of the AD and suggests that the compliance time be revised to within 5,000 flight hours after the effective date of the AD.

EMBRAER also requests that if the compliance time of within 90 days after the effective date of the AD is retained, we include the costs of unscheduled inspections. EMBRAER notes that the costs of unscheduled inspections would be higher than the estimate given in the promulgation of Special Federal Aviation Regulation No. 88 of between 60 and 330 work-hours for the inspection and between 36 and 96 hours for time out of service.

We agree to extend the “Grace Period” specified in Table 1 of this AD. We agree with ExpressJet that the compliance time of within 90 days after December 16, 2008 is appropriate. We have determined that the new compliance time will ensure an acceptable level of safety. We have revised Table 1 of this AD accordingly.

However, we do not agree with EMBRAER to defer the first mandatory inspections to within 5,000 flight hours after the effective date of the AD. In revising the appropriate compliance time for the inspections ( i.e. , extending the “Grace Period” to within 90 days after December 16, 2008), we considered the urgency associated with the subject unsafe condition, the availability of required parts, and the practical aspect of accomplishing the required inspections within a period of time that corresponds to the normal scheduled maintenance for most affected operators. If an operator decides that more time is needed to comply with the AD, the operator can request an alternative method of compliance (AMOC) in accordance with the provisions of paragraph (g)(1) of the supplemental NPRM.

As stated earlier, we have extended the compliance time and therefore the number of unscheduled inspections should be reduced. However, because operators' schedules vary substantially, it would be nearly impossible for us to accurately calculate all costs associated with unscheduled inspections. Therefore, we have not revised the Costs of Compliance section of this AD to reflect unscheduled inspections. However, we have revised the Costs of Compliance section of this AD to reflect a change in the number of airplanes affected by this AD from 704 (as specified in the supplemental NPRM) to 668 airplanes.

ExpressJet notes that paragraph (f)(2) of the supplemental NPRM states “Before December 16, 2008, revise the ALS of the ICA * * *.” ExpressJet states that it assumes that this is referring to the operator's ICA.

We infer that ExpressJet is requesting clarification of the actions in this AD. The wording that was used represents a standard approach and has been used for many years. The intent is to have all airworthiness limitations, regardless of whether imposed by original type certification or by a later AD, located in one immediately recognizable document. In 1980, the FAA identified the Airworthiness Limitations section of the Instructions for Continued Airworthiness as the appropriate document.

We consider that not having all airworthiness limitations in one document could lead to confusion as to what is or what is not a mandatory maintenance action as identified in Federal Aviation Regulation, part 25, Appendix H, section H25.4. This is the basis of our requirement to have each operator maintain a current copy of the Airworthiness Limitations section. Concerning ExpressJet's statement that the AD is referring to the operator's ICA, we infer that the commenter is wondering if, after revising its copy of the Airworthiness Limitation section, there are other required actions such as ensuring that the operator's maintenance program is updated to incorporate the actions specified in the revised Airworthiness Limitations.

Ensuring that operators' maintenance programs and the actions of its maintenance personnel are in accordance with the Airworthiness Limitations is required, but not by this AD. 14 CFR 91.403(c) specifies that no person may operate an aircraft for which airworthiness limitations have been issued unless those limitations have been complied with. Therefore, there is no need to further expand the requirements of the AD beyond that which was proposed because section 91.403(c) already imposes the appropriate required action after the airworthiness limitations are revised. We have not changed this AD in this regard.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a Note within the AD.

We estimate that this AD will affect 668 products of U.S. registry. We also estimate that it will take about 1 work- hour per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $53,440, or $80 per product.

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 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 this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We issued a supplemental notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That supplemental NPRM was published in the Federal Register on May 7, 2008 (73 FR 25606). That supplemental NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

EMBRAER request that we extend the compliance times specified in Table 1 of the supplemental NPRM. EMBRAER states that the compliance time “within 90 days of the effective date of the AD” for airplanes with cycle totals above the thresholds would require airplanes to be removed from service for special inspections and that these inspections would require the fuel tanks to be drained and ventilated prior to inspection. EMBRAER states that requiring unscheduled tank inspections will increase the probability of maintenance error, which will result in an increase in the risk of ignition sources. EMBRAER believes that there is no special risk that justifies the compliance time of within 90 days from the effective date of the AD and suggests that the compliance time be revised to within 5,000 flight hours after the effective date of the AD.

EMBRAER also requests that if the compliance time of within 90 days after the effective date of the AD is retained, we include the costs of unscheduled inspections. EMBRAER notes that the costs of unscheduled inspections would be higher than the estimate given in the promulgation of Special Federal Aviation Regulation No. 88 of between 60 and 330 work-hours for the inspection and between 36 and 96 hours for time out of service.

We agree to extend the “Grace Period” specified in Table 1 of this AD. We have determined that a compliance time of within 90 days after December 16, 2008 is appropriate and will ensure an acceptable level of safety. We have revised Table 1 of this AD accordingly. We do not agree with EMBRAER to defer the first mandatory inspections to within 5,000 flight hours after the effective date of the AD. In revising the appropriate compliance time for the inspections (i.e., extending the “Grace Period” to within 90 days after December 16, 2008), we considered the urgency associated with the subject unsafe condition, the availability of required parts, and the practical aspect of accomplishing the required inspections within a period of time that corresponds to the normal scheduled maintenance for most affected operators. If an operator decides that more time is needed to comply with this AD, the operator can request an alternative method of compliance (AMOC) in accordance with the provisions of paragraph (g)(1) of the supplemental NPRM.

As stated earlier, we have extended the compliance time and therefore the number of unscheduled inspections should be reduced. However, because operators' schedules vary substantially, it would be nearly impossible for us to accurately calculate all costs associated with unscheduled inspections. Therefore, we have not revised the Costs of Compliance section of this AD to reflect unscheduled inspections.

We have determined that tasks 28-41-01-720-001-A00 and 28-46-05-720-001-A00 in Table 1 of the supplemental NPRM are related to a functional check of the component rather than the aircraft system. We have discussed the issue with the manufacturer and with the Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil. ANAC states that it intends to issue an airworthiness directive to address an inspection threshold for these tasks. Therefore, we have removed these tasks from Table 1 of this AD. We might consider further rulemaking once new actions and compliance times for these tasks are identified by ANAC or in the absence of any new action from ANAC, we might consider unilateral rulemaking.

The number of airplanes on the U.S. Registry has changed since we issued the supplemental NPRM from 49 airplanes to 41 airplanes. We have revised the Costs of Compliance section of this AD accordingly.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 41 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $3,280, or $80 per product.

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 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 this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on May 1, 2008 (73 FR 23993). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD.

Based on the service information, we estimate that this AD will affect 50 products of U.S. registry. We also estimate that it will take about 3 work-hours per product to comply with basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $120 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $18,000 or $360 per product.

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 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 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 and placed it in the AD Docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

I. Background

On November 28, 2007 (72 FR 67524), HUD published a final rule revising its regulations governing mortgage insurance for hospitals. This final rule followed a January 10, 2005 (70 FR 1750), proposed rule and took into consideration public comment submitted on the proposed rule. The November 2007 final rule made certain changes in response to public comment and became effective on January 28, 2008. HUD's regulations promulgated by the November 2007 final rule implement section 242 of the National Housing Act (12 U.S.C. 1715z-7), and are codified at 24 CFR part 242.

Following publication of the November 2007 final rule, it was brought to HUD's attention that certain provisions of the regulatory text contained technical errors. In addition, upon reviewing the final rule in response to notification of technical errors, HUD identified other provisions in the regulatory text that HUD determined should be revised to improve clarity. The correction of these errors and the clarifying amendments made to the November 2007 final rule by this rule are as follows:

• Authority. The main authority for hospital mortgage insurance, section 242 of the National Housing Act (12 U.S.C. 1715z-7) was inadvertently omitted. This technical correction makes the appropriate revision to the authority citation.

• 24 CFR 242.1 (Definitions). The definition in the rule of “chronic convalescent and rest” refers to “rehabilitation services.” This element is not required by statute. This technical correction removes this term from the definition. A comment submitted on the proposed rule requested that HUD remove from the definition of “chronic convalescent and rest” the following terms: “respite care services,” “hospice services,” and “rehabilitation services.” HUD responded to the comment citing the statutory definition of “chronic convalescent and rest” as the reason for not removing these terms. However, while the terms “respite care services” and “hospice services” are part of the definition of “chronic convalescent and rest,” the term “rehabilitation services” is not part of the definition. (See 72 FR 67526-67527.) Accordingly, reference to “rehabilitation services” is removed from the definition of “chronic convalescent and rest.”

This rule also amends the definition of “mortgagee or lender” because the rule used the term “mortgagee” to refer to the applicant as well as the original lender. Therefore, a definition of “mortgagee” will clarify any possible ambiguity regarding to whom “mortgagee” refers.

The definition of “construction” inadvertently omitted reference to “substantial rehabilitation”. As is made clear in other parts of the rule, including in the definition of “project,” substantial rehabilitation such as additions and renovations are supported by the program. However, to remove any possible ambiguity, the phrase “or the substantial rehabilitation of an existing facility” is being added to the definition of “construction”.

With respect to the definition of “surplus cash,” it was the intent of the final rule that “surplus cash” includes cash from prior periods. This statement was made in the preamble of the final rule in response to public comments. (See 72 FR 67529.) This technical correction adds language to make this explicit in the definition of “surplus cash”.

• 24 CFR 242.10 (Eligible Mortgagors). This final rule amends the second sentence of this section because HUD discovered a possible unintended contradiction between § 242.10 and § 242.72. Section 242.10 provides that the mortgagor “shall possess the powers necessary and incidental to operating a hospital”. Under normal circumstances, that is indeed a requirement. However, § 242.72 creates a contradiction by permitting leasing arrangements to comply with certain state laws that prohibit public hospitals from mortgaging their property. Under such arrangements, the mortgagor of record is an entity (which may be created solely for the purpose of enabling the financing to take place) that does not “possess the powers necessary and incidental to operating a hospital”. The mortgagor simply serves as the owner, and it is the lessee-operator who possesses those powers. This amendment therefore removes any possible contradiction.

• 24 CFR 242.23 (Maximum Mortgage Amounts and Cash Equity Requirements). Where excess cash equity is needed, section 242(d)(6) of the National Housing Act (12 U.S.C. 1715z-7(d)(6)), entitles the mortgagor to fund the excess with a letter of credit at the option of the mortgagee. This is the mortgagee's option, not an option of HUD, but the November 28, 2007, final rule inadvertently presents this option as HUD's option. This rule corrects that error.

• 24 CFR 242.23, 242.35, 242.52, and 242.90 (Reference to “Rehabilitation”). The rule contains several references to the term “rehabilitation.” The program insures “substantial rehabilitation” in addition to new construction and, therefore, references to the term “rehabilitation” are generally in the context of “substantial rehabilitation.” Therefore, to avoid any possible ambiguity where the term “rehabilitation” is used alone, the term “substantial” has been added to precede this term wherever it appears.

• 24 CFR 242.33 (Covenant for Malpractice, Fire, and Other Hazard Insurance). Section 242.33 requires that the hospital have insurance coverage “acceptable to the mortgagee and HUD.” The amendment removes the word “and” from this phrase and substitutes the word “or.” The final rule did not intend to place the evaluation of acceptable insurance solely on the mortgagee. This amendment therefore provides the mortgagee with the option of assuming responsibility to determine the adequacy of insurance coverage, or leaving such determination to HUD.

• 24 CFR 50 (Funds and Finances: Off-Site Utilities and Streets). The November 2007 final rule inadvertently omitted “letter of credit” and use of a letter of credit has been a longstanding practice in this program. This rule corrects that omission.

• 24 CFR 242.56 (Form of Regulation). HUD amends this section to add a new sentence at the section's end which would restore a provision consistent with longstanding practice. This amendment relates to the issue of leasing, which is addressed in §§ 242.10 and 242.72. When leasing is permitted under § 242.72, it is the lessee that operates the hospital and whose financial results determine whether or not there is an insurance claim. HUD's established practice, prior to the final rule, has been to have the lessee, as well as the mortgagor of record, sign the Regulatory Agreement and be governed by its provisions. HUD did not intend for the revisions to §§ 242.10 and 242.72 to cause a departure from established practice.

• 24 CFR 242.58 (Books, Accounts, and Financial Statements). Paragraph (c) of this regulatory section describes the organizations that are subject to audit. While paragraph (c)(1) references not-for-profit organizations, this paragraph inadvertently omits reference to state and local governments, which have long been among those organizations that are audited in accordance with the Consolidated Audit Guide for Audits of HUD Programs and OMB Circular A-133, which authorities are referenced in paragraph (c)(1). This rule corrects that omission.

Additionally, a new paragraph (h) is added for the same reasons provided in the amendment to § 242.56.

• 24 CFR 242.61 (Management). Section 242.61(a) requires HUD's written approval before a mortgagor can execute a contract for management of the hospital. This technical correction makes explicit that this approval requirement refers to the management of the hospital, not to management of specific components of the hospital such as the pharmacy, cafeteria, etc.

In general, the Department publishes a rule for public comment before issuing a rule for effect, in accordance with its own regulations on rulemaking, 24 CFR part 10. However, part 10 does provide for exceptions from that general rule where the agency finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when prior public procedure is “impracticable, unnecessary, or contrary to the public interest” (24 CFR 10.1). In this case, public comment is unnecessary because HUD is making only technical corrections and clarifying amendments to a previously published final rule.

The undersigned, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed and approved this rule, and in so doing certified that this rule will not have a significant economic impact on a substantial number of small entities. This rule only makes technical corrections and clarifying amendments to a previously published final rule.

A Finding of No Significant Impact with respect to the environment was made in connection with this rulemaking in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact remains applicable, and is available for public inspection between 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-5000.

Executive Order 13132 (entitled “Federalism”) prohibits, to the extent practicable and permitted by law, an agency from promulgating a regulation that has federalism implications and either imposes substantial direct compliance costs on state and local governments and is not required by statute, or preempts state law, unless the relevant requirements of section 6 of the Executive Order are met. This final rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and on the private sector. This final rule does not impose any federal mandates on any state, local, or tribal government, or on the private sector, within the meaning of UMRA.

The Coast Guard will enforce special local regulations (SLR) on the navigable waters of Glorietta Bay in support of the Coronado July 4th Fireworks Show on July 4, 2008, from 8:30 p.m. until 10 p.m. These SLR will encompass a 100-foot radius around and under each fireworks barge while the fireworks barge is towed to its firing position. Once the barge is in position for the fireworks show, the SLR will be increased to a 500-yard radius around the barge. In order to ensure the safety of participants, spectators and transiting vessels, 33 CFR 100.1101 will be enforced for the duration of the event. Under provisions of 33 CFR 100.1101, vessels would be prohibited from entering into, transiting through or anchoring within the SLR without permission of the Coast Guard Patrol Commander.

In addition to this notice, the maritime community will be provided extensive advance notification via the Local Notice to Mariners allowing mariners to adjust their plans accordingly.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because any delay encountered in this regulation's effective date by publishing a NPRM would be contrary to public interest since immediate action is needed to provide for the safety of life and property on navigable waters.

Additionally, this temporary safety zone will only be enforced for 1 hour on July 09, 2008, and should have minimal impact on vessel transits due to the fact that vessels can safely transit through the zone when authorized by the Captain of the Port or his Representative and that they are not precluded from using any portion of the waterway except the safety zone area itself. For the same reasons above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On July 09, 2008, the City of Hampton, VA, will sponsor a fireworks display on the Chesapeake Bay shoreline centered on position 37°02′23.27″ N/076°17′22.54″ W (NAD 1983). Due to the need to protect mariners and spectators from the hazards associated with the fireworks display, access will be temporarily restricted within 350 feet of the fireworks launch site.

The Coast Guard is establishing a safety zone on the navigable waters of the Chesapeake Bay within 350 feet of position 37°02′23.27″ N/076°17′22.54″ W (NAD 1983). This safety zone will be established in the vicinity of the Buckroe Beach Park, Pier One in Hampton, VA, from 9 p.m. to 10 p.m. on July 9, 2008. In the interest of public safety, access within the safety zone will be restricted during the specified date and times. Except for participants and vessels authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. Although this regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) the safety zone if of limited size; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

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

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

This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in this portion of the Chesapeake Bay between 9 p.m. and 10 p.m. on July 9, 2008.

The safety zone will not have a significant economic impact on a substantial number of small entities because the zone will only be enforced for limited times and is of limited size. Additionally, vessel traffic can pass safely around the zone. Before the effective period, maritime advisories will be issued and made widely available to waterway users.

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.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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 and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded, under the instruction 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 checklist and a final categorical exclusion determination will be available in the docket where indicated under ADDRESSES .

On March 31, 2008, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone: Stars and Stripes Fourth of July Fireworks Event, Nansemond River, Suffolk, VA in the Federal Register (73 FR 16809). We received no comments on the proposed rule. No public meeting was requested, and none was held.

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 .

Delaying the effective date of this rule would be contrary to public interest since immediate action is needed to provide for the safety of life and property on navigable waters. Additionally, this temporary safety zone will only be enforced for a limited time and is of a limited size, the zone should have minimal impact on the public due to the fact that vessels can safely transit through the zone when authorized by the Captain of the Port or his Representative, the public is not precluded from using any portion of the waterway except the safety zone area itself.

On July 04, 2008, Suffolk Parks and Recreation will sponsor a fireworks display along the shoreline in position 36°44′27.3″N/76°34′42″ W (NAD 1983). Due to the need to protect the maritime public from the hazards associated with the fireworks display, access will be temporarily restricted within 600 feet of the fireworks launch site.

The Coast Guard is establishing a safety zone on specified waters of the Nansemond River in the vicinity of Constant's Wharf in Suffolk, VA. This safety zone will encompass all navigable waters within 600 feet of the fireworks barge located in position 36°-44′-27.3″N/076°-34′-42″ W (NAD 1983). This regulated area will be established in the interest of public safety during the Stars and Stripes spectacular event and will be enforced from 9 p.m. to 10 p.m. on July 04, 2008. Access within the safety zone will be restricted during the specified date and times. Except for those authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

No comments were received for this proposed rule. Two changes were made from the original proposal. These changes reduce the time that this regulated area will be enforced by three hours and expands the size of the zone by 100 feet.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. Although this regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) the zone is of limited size; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

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

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

This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the specified zone area during the enforcement period.

The safety zone will not have a significant economic impact on a substantial number of small entities because the zone will only be enforced for limited times and is of limited size. Additionally, vessel traffic can pass safely around the zone. Before the effective period, maritime advisories will be issued and made widely available to waterway users.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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 and Department of Homeland Security Management Directive 5100.1, which guide 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 checklist 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. Final approval and permitting of this event were not issued in time to engage in full notice and comment rulemaking. Publishing an NPRM and delaying the effective date would be contrary to the public interest since the event would occur before the rulemaking process was complete.

Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . In addition, it would be contrary to the public interest not to publish this rule because the event has been permitted and participants and the public require protection.

The Coast Guard is establishing, pursuant to 33 U.S.C. 1225, a temporary safety zone in support of the Paradise Point Resort 4th of July Display, near the navigation channel of Mission Bay off of Paradise Point. The safety zone is comprised of a 450 foot radius located around an anchored firing barge. This temporary safety zone is necessary to provide for the safety of the show's crew, spectators, participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

The Coast Guard establishes this temporary rule, pursuant to 33 U.S.C. 1225, to provide for the safety of the participants, spectators and other users of the waterways. This safety zone will be effective from 8:30 p.m. until 10 p.m. on July 3, 2008. This temporary safety zone is necessary to ensure the safety of participants and spectators of the Paradise Point Resort 4th of July Display. The duration of the display is expected to be approximately 15-20 minutes. The event involves one anchored barge, which will be used as a platform for launching of fireworks. The limits of this temporary safety zone include all areas within a 450 feet radius of the firing barge's location. The barge will be located approximately 450 feet southwest of Paradise Point in Mission Bay. This temporary safety zone is necessary to provide for the safety of the crews, spectators, participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

U.S. Coast Guard personnel will enforce this safety zone. Other Federal, State, or local agencies may assist the Coast Guard, including the Coast Guard Auxiliary. Section 165.23 of Title 33, Code of Federal Regulations, prohibits any unauthorized person or vessel from entering or remaining in a safety zone. Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Due to the temporary safety zone's short duration of one and a half hours, its limited scope of implementation, and because vessels will have an opportunity to request authorization to transit through the zone or the vessels may safely travel around the zone, the Coast Guard expects the economic impact of this rule to be so minimal that full regulatory evaluation under paragraph 10(e) of the regulatory policies and procedures of the DHS is unnecessary.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Mission Bay from 8:30 p.m. to 10 p.m. on July 3, 2008. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone only encompasses a small portion of the waterway, it is short in duration at a late hour when commercial traffic is low, vessels may safely travel around the safety zone, and the Captain of the Port may authorize entry into the zone, if necessary.

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 your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Petty Officer Kristen Beer, U.S. Coast Guard Sector San Diego at (619) 278-7233.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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. 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 and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded, under the Instruction, 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 because it establishes a safety zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because any delay encountered in this regulation's effective date by publishing a NPRM would be contrary to public interest since immediate action is needed to provide for the safety of life and property on navigable waters. Additionally, this temporary safety zone will only be enforced for 1 hour on July 03, 2008 and should have minimal impact on vessel transits due to the fact that vessels can safely transit through the zone when authorized by the Captain of the Port or his Representative and that they are not precluded from using any portion of the waterway except the safety zone area itself. For the same reasons above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On July 3, 2008, the Isle of Wight County, VA will sponsor a fireworks display on the Pagan River shoreline centered on position 36°59′18.26″ N/076°37′44.74″ W (NAD 1983). Due to the need to protect mariners and spectators from the hazards associated with the fireworks display, vessel traffic will be temporarily restricted within 420 feet of the fireworks launch site.

The Coast Guard is establishing a safety zone on the navigable waters of the Pagan River within the area bounded by a 420 foot radius circle centered on position 36°59′18.26″ N/076°37″44.74″ W (NAD 1983). This safety zone will be established in the vicinity of Smithfield, VA from 9 p.m. to 10 p.m. on July 3, 2008. In the interest of public safety, general navigation within the safety zone will be restricted during the specified date and times. Except for participants and vessels authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. Although this regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) the zone is of limited size; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

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

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

This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Pagan River between 9 p.m. and 10 p.m. on July 3, 2008.

The safety zone will not have a significant economic impact on a substantial number of small entities because the zone will only be enforced for limited times and is of limited size. Additionally, vessel traffic can pass safely around the zone. Before the effective period, maritime advisories will be issued and made widely available to waterway users.

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.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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 and Department of Homeland Security Management Directive 5100.1, which guide 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 checklist and a final categorical exclusion determination will be available in the docket where indicated under ADDRESSES .

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because any delay encountered in this regulation's effective date by publishing a NPRM would be contrary to public interest since immediate action is needed to provide for the safety of life and property on navigable waters. Additionally, this temporary safety zone will only be enforced for 1 hour on July 19, 2008 and should have minimal impact on vessel transits due to the fact that vessels can safely transit through the zone when authorized by the Captain of the Port or his representative and that they are not precluded from using any portion of the waterway except the safety zone area itself. For the same reasons above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On July 19, 2008, Clarksville Lake County Chamber of Commerce of Clarksville, VA will sponsor a fireworks display centered on the Highway 58 Bridge in Clarksville, VA in position 36°37′51″ N/078°32′50″ W (NAD 1983). Due to the need to protect mariners and spectators from the hazards associated with the fireworks display, vessel traffic will be temporarily restricted within 700-feet of the fireworks launch site.

The Coast Guard is establishing a safety zone on specified waters of John H. Kerr Lake within the area bounded by a 700-foot radius circle centered on position 36°37′51″ N/078°32′50″ W (NAD 1983) in the vicinity of Highway 58 Business Bridge in Clarksville, VA. This safety zone will be established in the interest of public safety during the 31st Annual Virginia Lakes Festival Fireworks event and will be enforced from 9 p.m. to 10 p.m. on July 19, 2008. General navigation within the safety zone will be restricted during the specified date and times. Except for participants and vessels authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. Although this regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; and (ii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in this portion of John H. Kerr Lake between 9 p.m. and 10 p.m. on July 19, 2008.

The safety zone will not have a significant economic impact on a substantial number of small entities because the zone will only be enforced for limited times and is of limited size. Additionally, vessel traffic can pass safely around the zone. Before the effective period, maritime advisories will be issued and made widely available to waterway users.

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.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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 and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded, under the instruction, 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 checklist and a final categorical exclusion determination will be 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. Final approval and permitting of this event were not issued in time to engage in full notice and comment rulemaking. Publishing an NPRM and delaying the effective date would be contrary to the public interest since the event would occur before the rulemaking process was complete.

Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . In addition, it would be contrary to the public interest not to publish this rule because the event has been permitted and participants and the public require protection.

The Coast Guard is establishing a temporary safety zone on the navigable waters of Mission Bay in support of the Mission Bay Yacht Club 4th of July Display. The safety zone is comprised of an 800-foot radius located around an anchored firing barge. This temporary safety zone is necessary to provide for the safety of the show's crew, spectators, and participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.

The Coast Guard establishes this temporary rule, pursuant to 33 U.S.C. 1225, to provide for the safety of the participants, spectators and other users of the waterways. This safety zone will be effective from 8 p.m. to 10 p.m. on July 4, 2008. This temporary safety zone is necessary to ensure the safety of participants and spectators of the Mission Bay Yacht Club 4th of July Display. The duration of the show is expected to be approximately 20-25 minutes. The event involves one anchored barge, which will be used as a platform for launching of fireworks. The limits of the temporary safety zones include all areas within an 800-foot radius around an anchored barge. The barge will be anchored at a location approximately 600 feet east of the Santa Clara Point. This temporary safety zone is necessary to provide for the safety of the crews, spectators, participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

U.S. Coast Guard personnel will enforce this safety zone. Other Federal, State, or local agencies may assist the Coast Guard, including the Coast Guard Auxiliary. § 165.23 of Title 33, Code of Federal Regulations, prohibits any unauthorized person or vessel from entering or remaining in a safety zone. Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Due to the temporary safety zone's short duration of one and a half hours, its limited scope of implementation, and because vessels will have an opportunity to request authorization to transit through the zone or the vessels may safely travel around the zone, the Coast Guard expects the economic impact of this rule to be so minimal that full regulatory evaluation under paragraph 10(e) of the regulatory policies and procedures of the DHS is unnecessary.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Mission Bay from 8:30 p.m. to 10 p.m. on July 4, 2008. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone only encompasses a small portion of the waterway, it is short in duration at a late hour when commercial traffic is low, vessels may safely travel around the safety zone, and the Captain of the Port may authorize entry into the zone, if necessary.

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 your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Petty Officer Kristen Beer, U.S. Coast Guard Sector San Diego at (619) 278-7233.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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. 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 and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded, under the Instruction, 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 because it establishes a safety zone. 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. Final approval and permitting of this event were not issued in time to engage in full notice and comment rulemaking. Publishing an NPRM and delaying the effective date would be contrary to the public interest since the event would occur before the rulemaking process was complete.

Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . In addition, it would be contrary to the public interest not to publish this rule because the event has been permitted and participants and the public require protection.

The Coast Guard is establishing four (4) temporary safety zones on the navigable waters of San Diego Bay in support of the North San Diego Bay July 4th Fireworks Show. These temporary safety zones are necessary to provide for the safety of the crews, spectators, participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within these safety zones unless authorized by the Captain of the Port, or his designated representative.

The Coast Guard establishes this temporary rule, pursuant to 33 U.S.C. 1225, to provide for the safety of the participants, spectators and other users of the waterways. These safety zones will be effective from 8 p.m. to 10 p.m. on July 4, 2008. These four temporary safety zones are necessary to ensure the safety of participants and spectators of the North San Diego Bay July 4th Fireworks Show. The duration of the show is expected to be approximately 20-25 minutes. The event involves four (4) anchored barges, which will be used as platforms for the launching of fireworks.

The limits of the temporary safety zones include all areas within a 1200 foot radius around the firing locations at the following points: 32-42.83′ N, 117-13.20′ W (in vicinity of Shelter Island), 32-43.33′ N, 117-12.00′ W (in vicinity of Harbor Island), 32-43.00′ N, 117-10.80′ W (in vicinity of North Embarcadero), and 32-43.23′ N, 117-10.05′ W (in vicinity of Seaport Village/Coronado Landing).

These temporary safety zones are necessary to provide for the safety of the crews, spectators, participants of the event, participating vessels and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within these safety zones unless authorized by the Captain of the Port, or his designated representative.

U.S. Coast Guard personnel will enforce this safety zone. Other Federal, State, or local agencies may assist the Coast Guard, including the Coast Guard Auxiliary. § 165.23 of Title 33, Code of Federal Regulations, prohibits any unauthorized person or vessel from entering or remaining in a safety zone. Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Due to the temporary rule's short duration of two hours, its limited scope of implementation, and because vessels will have an opportunity to request authorization to transit through the zone or the vessels may safely travel around the zone, the Coast Guard expects the economic impact of this rule to be so minimal that full regulatory evaluation under paragraph 10(e) of the regulatory policies and procedures of the DHS is unnecessary.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of North San Diego Bay from 8 p.m. to 10 p.m. on July 4, 2008.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone only encompasses a small portion of the waterway, it is short in duration at a late hour when commercial traffic is low, vessels may safely travel around the safety zone, and the Captain of the Port may authorize entry into the zone, if necessary.

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 your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Petty Officer Kristen Beer, U.S. Coast Guard Sector San Diego at (619) 278-7233.

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). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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 and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded, under the Instruction, 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 because it establishes a safety zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

EPA is publishing this rule without prior proposal because we view this as a noncontroversial action and anticipate no adverse comment. The amendments being implemented revise certain technical requirements in 40 CFR part 63, Subpart CCCCCC. However, in the “Proposed Rules” section of this Federal Register , we are publishing a separate document that will serve as the proposed rule for these amendments if adverse comments are received on this direct final rule. If EPA receives adverse comment on all or a distinct portion of this rule, we will publish a timely withdrawal in the Federal Register informing the public that some of or this entire direct final rule will not take effect. The rule provisions that are not withdrawn will become effective on the date set out above, notwithstanding adverse comment on any other provision, unless we determine that it would not be appropriate to promulgate those provisions due to their being affected by the provision for which we receive adverse comments. We would address all public comments in any subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

Submitting CBI. Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

Regulated Entities. Categories and entities potentially regulated by this action include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this final rule. To determine whether your facility is regulated by this action, you should examine the applicability criteria in 40 CFR part 63, subpart CCCCCC. If you have any questions regarding the applicability of this final rule to a particular entity, consult either the air permit authority for the entity or your EPA regional representative as listed in 40 CFR 63.13.

Worldwide Web (WWW). In addition to being available in the docket, an electronic copy of this final rule is also available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of this final rule will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at the following address: http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control.

Outline: The information presented in this preamble is organized as follows:

On January 10, 2008 (73 FR 1916), EPA issued a final rule that established national emission standards for hazardous air pollutants (NESHAP) for the facilities in the gasoline distribution (Stage I  1 ) area source category. These facilities include bulk distribution facilities, i.e., gasoline distribution bulk terminals, bulk plants, and pipeline facilities, and gasoline dispensing facilities (GDF), as defined in 40 CFR 63.11100 and 63.11132. EPA subsequently identified certain cross-referencing errors in the final rule. On March 7, 2008 (73 FR 12275), EPA promulgated a technical corrections notice and corrected those errors. As explained below, this action amends certain requirements of the January 10, 2008 final rule that apply to GDF with a monthly throughput of 100,000 gallons or more.

EPA is withdrawing the final rule which was published on September 12, 2000 (65 FR 54955) in response to IBM's request to discontinue the XL project. The final rule granted IBM an exemption under Project XL from the F006 hazardous listing for sludge generated from the treatment of copper electroplating rinsewaters. IBM has implemented a new process step that has caused the wastewater treatment sludge to once again become F006 listed hazardous waste and is complying with the Vermont Department of Environmental Conservation requirements for this listed waste. Discontinuing the XL project will have no environmental impact. All reporting requirements in 40 CFR 261.4(b)(16) are discontinued.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because EPA is withdrawing a rule that no longer applies to the company and the company has notified us that the project has terminated. The removal of the rule has no legal effect. Notice and public procedure would serve no useful purpose and is thus unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., because it is withdrawing a rule that was not implemented and does not impose any new requirements.

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.

Today's final rule is not subject to the Regulatory Flexibility Act (RFA), which generally requires an agency to prepare a regulatory flexibility analysis for any rule that will have a significant economic impact on a substantial number of small entities. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA) or any other statute. This rule is not subject to notice and comment requirements under the APA or any other statute because it withdraws a rule that applied to only one facility and does not impose any new requirements. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute [see SUPPLEMENTARY INFORMATION section], it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

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 to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA 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, enabling 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.

Today's rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector. The rule imposes no enforceable duty on any State, local or tribal governments or the private sector. ( Note: The term “enforceable duty” does not include duties and conditions in voluntary federal contracts for goods and services.) Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute [see SUPPLEMENTARY INFORMATION section], it is not subject to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

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 final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule withdraws a rule that was specific to one facility. 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 9, 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.” This final rule does not have tribal implications, as specified in Executive Order 13175. This final rule withdraws a rule that was not implemented. Thus, Executive Order 13175 does not apply to this rule.

(62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

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

As noted in the proposed rule, 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. This action does not involved technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This rule applies to one facility and withdraws a rule that was not implemented.

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. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because it is a rule of particular applicability and does not impose any new requirements.

I. Why Is EPA Using a Direct Final Rule?

We are publishing this as a direct final rule because we view this as a noncontroversial action. We are simply removing the NO X component from the Phase 3 snowmobile emission standard equation as required by the court decision. However, in the “Proposed Rules” section of today's Federal Register , we are publishing a separate document that will serve as the proposed rule to consider adoption of the provisions in this direct final rule if adverse comments or a request for a public hearing are received on this action. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

If EPA receives adverse comment or a request for a public hearing, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

This action will affect companies that manufacture, sell, or import into the United States new snowmobiles and new spark-ignition engines for use in snowmobiles. This action may also affect companies and persons that rebuild or maintain these engines. Affected categories and entities include the following:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. To determine whether particular activities may be affected by this action, you should carefully examine the regulations. You may direct questions regarding the applicability of this action as noted in FOR FURTHER INFORMATION CONTACT .

A. Submitting CBI. Do not submit Confidential Business Information (CBI) to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR Part 2.

B. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

In November 2002, we adopted emission standards for new snowmobiles. 1 The program contained three phases of standards. The Phase 1 standards, effective with the 2006 model year, and the Phase 2 standards, effective with the 2010 model year, contained limits for CO and HC emissions. The Phase 3 standards, effective with the 2012 model year, also contained a NO X component in addition to CO and HC components, effectively creating separate HC+NO X and CO emission standards for 2012 and later model years. Each set of these standards permits emissions averaging among a manufacturer's engine families.

The form of the Phase 3 standards also differed from the Phase 1 and 2 standards. While the Phase 1 and 2 standards simply contained numerical limits for CO and HC, the Phase 3 standards were in the form of an equation, as follows:

The two main advanced technologies we anticipated being used to meet the Phase 3 standards (direct or semi-direct injection 2-stroke engines, and 4-stroke engines) tend to have rather different emissions profiles, and the equation was designed to allow manufacturers to use varying mixes of these technologies as the market would allow, while still achieving substantial emission reductions. The Phase 3 standard equation in essence requires nominal 50 percent reductions in CO and HC compared to uncontrolled levels, which are 150 g/kW-hr for HC and 400 g/kW-hr for CO. However, the equation is structured such that mixes of CO and HC reductions can be used. In conjunction with a straight HC limit of 75 g/kW-hr (ensuring at least 50 reduction in HC) and a corporate average CO standard that could not exceed 275 g/kW-hr (ensuring at least approximately 30 reduction in CO), the equation allows up to 70 percent reductions of HC and 30 percent reductions of CO, as long as the percentage reduction of both pollutants combined is at least 100 percent. As previously mentioned, the Phase 3 equation also contained a NO X component. We did not want the anticipated increased use of 4-stroke engines (which tend to have higher NO X emissions as compared to 2-stroke engines) to result in fleet average increases in snowmobile NO X emissions. Thus, we included in the Phase 3 equation a NO X term that was intended to cap NO X emissions, and a “−15” term that was intended to account for NO X emissions from existing 4-stroke engines. See 67 FR 68272-68275.

Following the promulgation of the November 2002 final rule, Bluewater Network, Environmental Defense and the International Snowmobile Manufacturers Association petitioned for review of the rule in the Court of Appeals for the District of Columbia. The court upheld much of the rule and rationale, but made two determinations requiring further action by EPA. See Bluewater Network v. EPA, 370 F. 3d 1 (D.C.Cir 2004) First, the court vacated the NO X portion of the Phase 3 standards, stating that EPA did not have authority to adopt NO X standards for snowmobiles under the section 214(a)(4) of the Clean Air Act. Second, the court remanded the CO and HC portions of the Phase 3 standards for us to clarify the evidence and analysis upon which the standards are based. Today's action pertains to the first portion of the court's ruling. In contrast to today's action, addressing the remand of the 2012 CO and HC emission standards will require more deliberate study. Thus, we will be addressing those standards in a separate rulemaking action; we are not addressing them here. Our intention is to release a Notice of Proposed Rulemaking in the 2009 timeframe, with a Final Rule in the 2010 timeframe.

Today's action consists of modifications to the Phase 3 emission standard equation shown above. In that equation (40 CFR 1051.103), we are removing both the component requiring addition of NO X emissions to HC emissions (the HC component remains) and the component reducing that sum by 15, to read as follows:

In previous years, the General Services Administration (GSA), Office of Governmentwide Policy published the annual tax tables for Federal, State, and Puerto Rico used for calculating the RIT allowance to be paid to relocating Federal employees, in the Federal Register . These tax tables have been located in 41 CFR part 302-17 as Appendices A through D.

This final rule informs Government agencies that the Federal, State, and Puerto Rico tax tables (41 CFR part 302-17, Appendices A through D) will no longer appear in the Federal Register or in 41 CFR part 302-17. From now on, these tax tables will be published similar to other tables of rates that implement long-standing policies, such as the domestic per diems, relocation mileage, and travel mileage rates, and appear as Federal Travel Regulation (FTR) bulletins. You may find the FTR bulletins with the annual RIT allowances at www.gsa.gov/ftrbulletin . The tax table will also be published at www.gsa.gov/relo . This final rule removes Appendices A through D of 41 CFR part 302-17, adds a new section to that part that will provide a cross reference to the tax tables, and amends references to part 302-17 Appendices A through D in applicable sections of the FTR.

These tax tables are developed from several sources of information ( e.g. , the IRS, individual state taxing authorities, and the Commonwealth of Puerto Rico Department of the Treasury). GSA has determined that publishing these tax tables annually in the Federal Register is a time consuming and costly process that will no longer be needed when this same information is posted as FTR bulletins. As a result of the newly implemented process, the information will be available to the agency and relocating employees in a more timely manner. As part of GSA mission to serve its Federal customers as quickly as permitted, this change in delivering the RIT Allowance Tables is now implemented by this final rule.

This final rule is a response to agency personnel who process relocation vouchers and must delay the reimbursements because they are waiting for the most current RIT Allowance Tables to be published. By moving to the FTR bulletin process, this information will be available for the calculation of reimbursements much earlier in the calendar year and will therefore benefit both agencies and their relocating employees.

This final rule removes Appendices A through D of 41 CFR part 302-17 and adds a new section 302-17.14 to that part which will serve as a cross-reference to the location of the calendar 2008 RIT Tables and all subsequent changes to the RIT Allowance Tables in FTR bulletins. This information will be able to be accessed at both www.gsa.gov/ftrbulletin and www.gsa.gov/relo . This final rule also amends numerous sections in FTR part 301-11, 302-17.5, 302-17.8, and 302-17.10.

This final rule is excepted from the definition of “regulation” or “rule” under Section 3(d)(3) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993 and, therefore, was not subject to review under Section 6(b) of that executive order.

This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , does not apply.

The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

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

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

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

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act . This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act . As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

Executive Order 13132, Federalism . This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform . This final rule meets the applicable standards of Executive Order 12988.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under both 5 U.S.C. 553(b)(A) and (b)(B), the Coast Guard finds this rule is exempt from notice and comment rulemaking requirements because these changes involve agency organization and practices, and good cause exists for not publishing an NPRM for all revisions in the rule because they are all non-substantive changes. This rule consists only of corrections and editorial, organizational, and conforming amendments. These changes will have no substantive effect on the public; therefore, it is unnecessary to publish an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

The Coast Guard periodically makes technical amendments to Title 46 of the Code of Federal Regulations. This rule, which becomes effective June 25, 2008, updates 46 CFR 31.10-16 concerning inspection and certification of shipboard cargo gear. This rule does not create any substantive requirements.

This rule adds the National Cargo Bureau, Inc. (NCB) to 46 CFR 31.10-16(e) as an organization authorized by the Coast Guard to perform inspections of shipboard cargo gear. In a letter dated March 28, 2007, the Chief of the Office of Vessel Activities, U.S. Coast Guard, confirmed that the NCB is authorized to perform such inspections, and has been since 1960. In a Federal Register notice dated December 24, 1960, the Coast Guard announced that valid current certificates and/or registers issued by the NCB may be accepted as prima facie evidence of the condition of such gear. 25 FR 13730. The letter and notice are available under docket number USCG-2008-0394 where indicated under the ADDRESSES section of this preamble. This technical amendment will afford the public appropriate notice of the NCB's existing authorization to conduct shipboard cargo gear inspections.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analysis based on 12 of these statutes or executive orders.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. As this rule involves internal agency practices and procedures and non-substantive changes, it will not impose any costs on the public.

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 rule does not require a general NPRM and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. The Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. 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 and Department of Homeland Security Management Directive 5100.1, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have 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, paragraphs (34)(a) and (b) of the Instruction, from further environmental documentation because this rule involves editorial, procedural, and internal agency functions. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

The Omnibus Transportation Employee Testing Act of 1991, 49 U.S.C. 31300, et seq. , 49 U.S.C. 20100, et seq. , 49 U.S.C. 5330, et seq. , and 49 U.S.C. 45100, et seq. (the Omnibus Act), requires the U.S. Department of Transportation (DOT) to use the laboratories certified by, and testing procedures of, the U.S. Department of Health and Human Services (HHS) to ensure “the complete reliability and accuracy of controlled substances tests.” Since Congress specifically limited the scientific testing methodology upon which the DOT can rely in making its drug and alcohol testing regulations, we follow the HHS scientific and technical guidelines, including the amendments to their Mandatory Guidelines.

In its final rule of December 2000 [65 FR 79526], the U.S. Department of Transportation (DOT) made specimen validity testing (SVT) mandatory for the transportation industry contingent upon the HHS publishing its Mandatory Guidelines on SVT. DOT anticipated that HHS would, sometime in 2001, amend its Mandatory Guidelines to establish SVT requirements for HHS-certified laboratories. When it appeared that HHS would not establish final SVT requirements in 2001, we amended 49 CFR part 40 (part 40) to remove the mandatory requirement. We believed it advisable to wait until HHS completed its amendment before making SVT mandatory throughout the transportation industries for all DOT specimens.

On August 9, 2001, the DOT amended part 40 [66 FR 41952] to remove the mandatory requirement because HHS had not finalized its Mandatory Guidelines regarding SVT. SVT would remain authorized but not required.

The DOT issued a May 28, 2003 interim final rule (2003 IFR) [68 FR 31626] in response to scientific and medical information suggesting we modify testing criteria for some specimens that had been considered to be substituted and ultimately were treated as refusals to test. The 2003 IFR modified how the medical review officer (MRO) would deal with any substituted result with creatinine concentrations equal to or greater than 2, but less than or equal to 5 mg/dL [hereafter, “2-5 mg/dL range”]. It did not change the HHS substitution criteria that we had used.

On April 13, 2004, the HHS published a Federal Register notice revising its Mandatory Guidelines [69 FR 19644] with an effective date of November 1, 2004. Among the revisions contained in the HHS Mandatory Guidelines were requirements that laboratories modify substituted and diluted specimen testing procedures and reporting criteria. The HHS also revised laboratory requirements for adulterated specimen testing and made SVT mandatory for Federal employee testing under the HHS Federal Workplace Drug Testing Program.

In an IFR (2004 IFR) [69 FR 64865] published on November 9, 2004, the DOT changed a number of items in part 40 to make them consistent with the HHS Mandatory Guidelines. We did this to avoid conflicting requirements that implementation of both rules would have had on laboratories and MROs.

While the HHS Mandatory Guidelines' approach to substituted test results allowed DOT to simplify its guidance to MROs on how to deal with those results, there were several important differences between the 2004 IFR and the HHS Guidelines. The most important among them was the fact that SVT, though authorized by part 40 and the 2004 IFR, was not yet required.

In the 2004 IFR, we indicated that we intended to fully address all aspects of the HHS changes to their Mandatory Guidelines in a notice of proposed rulemaking (NPRM). We also said that we would take into consideration any subsequent HHS materials (e.g., HHS MRO Manual) and would update our cost figures for SVT in the context of making SVT mandatory.

Subsequently, the DOT published—on October 31, 2005—an NPRM [70 FR 62276] responding to comments made to the 2003 IFR and to the 2004 IFR. The NPRM also proposed making SVT mandatory and included a number of other proposed technical changes, mostly clarifying the procedures related to testing and reporting of adulterated, substituted, and invalid specimens.

A total of 27 commenters responded to the 2005 NPRM, making 234 separate comments. Eight commenters were individuals with no known affiliations; seven were MROs representing themselves or their organizations; two were employers; one was a Third-Party Administrator (TPA); four represented associations; four represented labor unions; and one represented a drug testing laboratory.

Eleven commenters expressed general support for the DOT effort to establish clear requirements for SVT that were consistent with the HHS procedures. Of these eleven, one individual thought the SVT rules should be more rigorous; four others commended the DOT in its efforts; one TPA thought the effort admirable; two labor unions commended and supported the DOT's efforts; one association applauded the effort; and one laboratory supported DOT efforts to bring more consistency on SVT with the HHS.

Six commenters specifically supported making SVT mandatory and five specifically opposed this proposal. Several stated that authorizing SVT is sufficient to address adulteration and substitution issues. A number of commenters provided numerous technical suggestions, supported most of the proposed changes or additions, and were interested in establishing relevant procedures to address the various issues of adulterated, substituted, and invalid test results.

A number of commenters were concerned about the current state of science related to SVT testing as compared to that of drug testing. At least two commenters believed the DOT needed to require laboratories to utilize two separate methodologies for certain SVT. However, this would require laboratories to change testing protocols that the HHS does not mandate.

A number of commenters supported the DOT's proposal to rectify past problems related to substituted specimens and suggested a number of options and recommendations. We appreciate the input from the commenters and considered their comments in the Informational Notice Regarding Certain Substituted Specimens published in the Federal Register on September 11, 2007 [72 51887]. Because we addressed those issues in that notice, we will not deal with them in this final rule.

A number of commenters raised part 40 issues unrelated to the proposed SVT issues. We have not addressed these unrelated items in this preamble because they are outside the scope of the NPRM.

Finally, the NPRM proposed or asked a number of major policy questions relevant to SVT. We specifically address major policy issues in a separate section and address the others in section-by-section discussions.

The DOT proposed making SVT mandatory, as in the current HHS Federal employee testing program.

Most commenters concurred with DOT's proposal to make SVT mandatory. Some commenters acknowledged this was necessary because the increase in products designed to adulterate specimens has made tampering with specimens more prevalent. The commenters also supported mandatory SVT because it would bring better control over the SVT process.

A number of commenters expressed concern that the science of SVT has yet to evolve to the same level of accuracy, reliability, and defensibility as the science of drug testing. Some of these commenters recommended that SVT should remain elective.

Several commenters believed that the DOT should require all laboratories to employ two separate SVT methodologies for adulterants because this would ensure more confirmed adulteration results. The commenters reasoned that laboratories would be more likely to report invalid results if they only used one SVT methodology.

Other comments on mandatory SVT included concerns about costs and the extent of adulterant testing. Some commenters believed the DOT's cost estimates for SVT were low. They requested clarification on the anticipated costs of initiating mandatory testing. Commenters also expressed concerns that laboratories were not testing for all adulterants.

The DOT continues to believe that mandatory testing for specimen validity is an appropriate response to the use of adulterants and attempts to subvert the collection and testing process. The HHS Mandatory Guidelines established SVT requirements with which laboratories must comply in order to become and remain HHS-certified. The HHS has stated that its SVT standards are designed to produce the most accurate, reliable, and correctly interpreted test results.

Currently, when DOT specimens are tested for validity, the HHS procedural standards apply. There is no reason to presume that these standards are scientifically insufficient. Therefore, we will require that urine specimens tested under the DOT-industry programs will be subject to the HHS procedural standards for SVT.

We will continue to utilize HHS instructions to laboratories for establishing cutoffs and directing laboratory analysis regarding creatinine levels. Within part 40, we added procedures to allow an employee to provide evidence to the MRO that he or she can produce a urine specimen below the 2.0 mg/dL cutoff. We created this procedural safeguard in the 2000 regulation because a small number of employees assert they may be capable of providing urine specimens with creatinine levels below 2.0 mg/dL, and that such low creatinine levels are not the result of tampering with their specimens. By adding an evidentiary process for results below the 2.0 mg/dL cutoff, we believe that we have created sufficient safeguards to protect employees from being wrongfully accused of tampering with their specimens.

The DOT shares the commenters' concerns about laboratories choosing to use one adulterant testing methodology because using one methodology instead of two may result in obtaining invalid results rather than confirmed adulterated results. However, HHS mandates all scientific and procedural requirements for drug testing at HHS-certified laboratories. HHS provides guidance to the laboratories on use of a secondary confirmatory methodology when a laboratory performs confirmatory adulteration testing. HHS authorizes, but does not require, laboratories to perform confirmatory adulteration testing. The Omnibus Act requires the DOT to incorporate the HHS scientific and technical guidelines, and we do not have the authority to impose additional scientific and technical requirements upon the laboratories.

While current laboratory testing data show a slight rise in invalid results and a slight decline in adulterated results over previous years, we do not have data based solely upon implementation of full SVT because the DOT has not required full implementation. As a consequence, the DOT will initiate permanent 6-month reviews of laboratory data on DOT-regulated specimens to obtain more specific information about this issue now that SVT will be mandatory for all DOT-regulated specimens. We will look at the reasons drug test results are classified as invalid versus adulterated to determine if use of one methodology instead of two is likely to cause more invalid results and fewer confirmed adulterated results. Part 40 requires laboratories to submit to DOT specific information regarding their SVT following full implementation. The regulatory text requiring this information is at § 40.111; and the required data are listed at Appendix C. We will use this information in our continuing discussions with HHS and others regarding SVT. We also want the information so that we can know the full scope of laboratory data on DOT-regulated tests.

The DOT cost estimates for full SVT and for laboratory data collections are in the regulatory analyses and notices section of this preamble.

The DOT asked if we should continue to require laboratories to contact MROs before reporting invalid results.

Several commenters, mostly MROs, responded to this question and generally indicated that laboratories are not routinely contacting them about invalid results as required by HHS and DOT. Some commenters were concerned that the rule text does not specify whether the MRO or the laboratory has the final decision on the disposition of the specimen. Also, the commenters expressed concern about whether the employer would be required to pay for sending the specimen to another laboratory. One commenter pointed out that DOT is requiring the MRO to discuss the result with “the certifying scientist” while HHS requires the MRO to discuss the result with the “laboratory.” Some laboratory personnel other than a certifying scientist, for example the Responsible Person (RP), may discuss invalids with the MRO. This commenter supported having the MRO talk with “a certifying scientist.”

The rule continues to require laboratories to contact the MRO prior to reporting an invalid result, a requirement which mirrors the current HHS Mandatory Guidelines. The fact that some laboratories may not be following this requirement is not sufficient reason to suspend or disregard this procedure. The HHS identifies 12 separate criteria for identifying a specimen as invalid. Of these 12, the first three do not require laboratory contact with MROs. It is entirely possible that many of the invalid results fall under these three criteria and may explain the reason that contact between the laboratories and the MROs appears lacking. These three criteria are:

1. Inconsistent creatinine concentration and specific gravity results;

2. The pH is greater than or equal to 3 and less than 4.5, or greater than or equal to 9 and less than 11; or

3. The nitrite concentration is greater than or equal to 200 mcg/mL, but less than 500 mcg/mL.

As indicated before, some laboratory testing methodologies may differ. If the invalid result is related to the criteria listed in the HHS Mandatory Guidelines—under sections 2.4(7), (iv) through (xii), the MRO and laboratory might conclude it is beneficial to conduct another test at a different laboratory to obtain a result that is not invalid. This would require a certifying scientist and the MRO to discuss the benefit of sending the specimen to another laboratory and to determine which laboratory would be able to conduct the appropriate test.

A few commenters requested that DOT specify whether the MRO or a certifying scientist would make the determination to send a specimen to another laboratory. The DOT believes this is a mutual decision to be made by both the MRO and a certifying scientist.

Regarding payment for additional testing, the DOT's position is similar to our stance on paying for split specimen testing. Regardless of who pays or how, it is the employer's responsibility to ensure that procedures are in place to accomplish the additional testing. We believe the cost of any additional tests would be less than the subsequent cost of recollecting under direct observation when the first laboratory reported the result as invalid.

One commenter said that the NPRM's reference to the MRO's conferring with “the certifying scientist” should remain “a certifying scientist”—as it is in the current rule text. We agree, and our regulation reflects this.

The DOT proposed to adopt the HHS blind specimen certification criteria. HHS provides technical oversight to the laboratories, and quality control is part of that very important oversight. We did not receive comments regarding this proposal. Therefore, the DOT has adopted the HHS criteria for blind specimen certification.

The DOT proposed adopting the 2004 IFR's approach to the treatment of negative-dilute specimens with creatinine in the 2-5 mg/dL range, which requires recollection under direct observation. The DOT requested comments about continuing this requirement. The majority of commenters supported the proposal to require recollections under direct observation for negative-dilute results with creatinine in the 2-5 mg/dL range.

Several commenters indicated that there was an increase in positive results from the directly observed recollections, while others stated the results were mostly negative. Most of these commenters provided anecdotal information. However, one commenter's data showed that a significant number of the directly observed recollections produced non-negative results.

The DOT will continue to require the MRO to direct employers to conduct immediate recollections under direct observation when the original specimen is reported with a creatinine concentration in the 2-5 mg/dL range. We think the number of non-negatives produced during directly observed recollections is significant and justifies continuing the recollection requirement.

Although a few individuals claim the ability to produce urine specimens with this concentration of creatinine, there has been no conclusive evidence that this is a common occurrence. Concentration of creatinine at these levels is not the norm. In the interest of public safety, the DOT believes that a recollection under direct observation is a reasonable requirement.

The DOT proposed not adopting the HHS MRO Manual guidance for an MRO to report a negative result if the MRO believed there was a legitimate medical explanation for the substituted specimen. There were no comments related to this item.

Under part 40, the MRO will continue to have the ability to verify substituted specimens with medical explanations as cancelled tests. Because there are virtually no medical explanations for substituted results, the MRO must continue to report to DOT the medical basis for canceling the test.

The following part of the preamble discusses each of the final rule's sections, including responses to comments on each section.

The DOT proposed to modify some existing section headings and add two new section headings to reflect regulation text changes. Seven section headings have been modified or added. Two commenters responded to this proposal and both supported it.

In order to align more closely the definitions in § 40.3 with definitions contained in the HHS Mandatory Guidelines, the DOT proposed modifying some existing definitions and adding several new ones.

Commenters supported this proposal and responded by making suggested additions or changes to this section. Several commenters, especially MROs, recommended adoption of the term “hyperdilute” or “superdilute” to distinguish references to those negative-dilute specimens with creatinine concentrations in the 2-5 mg/dL range. They recommended that positive specimens the MROs downgrade to negatives be recollected if they are dilute with creatinine concentrations in the 2-5 mg/dL range. Additionally, the terms “cancelled-invalid” and “confirmatory creatinine and specific gravity tests” are used in the text. Commenters asked if these should be included in the definitions.

The DOT will modify eight definitions and add five new ones. We will include a definition of the term “aliquot” as defined in the HHS Mandatory Guidelines. For the term “Oxidizing adulterant” we did provide HHS' examples of these agents.

We will not use of the term “hyperdilute” or “superdilute” to describe a dilute specimen with creatinine concentrations in the 2-5 mg/dL range. Laboratories do not report specimens with creatinine concentrations in the 2-5 mg/dL range as “hyperdilute” or “superdilute” but rather as dilute with a numerical value. To require the use of this term in the reporting process would require laboratories to change their reporting format and the DOT will not direct them to do that.

Additionally, some MROs may think that the use of this term would somehow make it easier for them to report these results to the designated employer representative (DER). However, even if we adopted this term, the DERs would still have to be told that the reason for the test result being “hyperdilute” or “superdilute” is that the creatinine concentration fell in the 2-5 mg/dL range. The DOT does not think that adding a different name to a test result would in any way improve laboratory and MRO procedures.

We also proposed to use the term “cancelled-invalid” in the NPRM. However, we will not include this term in the text since laboratories will not report tests as being “cancelled-invalid.” In addition, current requirements call for the MRO to check the cancelled box on the Federal Drug Testing Custody and Control Form (CCF) and, on the remarks line, write that the reason is an invalid result. We think this is sufficiently clear in describing the test outcome. We will not add another term to the current lexicon of drug testing results. We use the term “cancelled” in the rule text rather than “cancelled-invalid.”

One commenter asked if a definition should be developed to describe what is meant by a confirmatory creatinine and specific gravity test. The DOT believes that the terms “confirmatory creatinine test” and “confirmatory specific gravity test” are self-explanatory and do not need more specific definitions. A confirmatory specimen validity test is just that, a test on a separate aliquot to confirm the results of an initial specimen validity test.

The DOT will make SVT mandatory by removing the option to conduct SVT and adding text requiring SVT. This proposal had a majority of favorable comments. Specific discussion of this item is listed under Principal Policy Issues.

The DOT proposed adding two tables (one at the existing § 40.95, the other at a new § 40.96) to inform MROs and others about the cutoffs and the procedures HHS directs laboratories to use in reporting adulterated and invalid test results. We sought comments on whether this information would be helpful to MROs and others, or would have too much information and be too complicated to add value.

Most commenters supported the proposal to include two tables related to adulterant and invalid testing cutoffs. The DOT, however, did not include these tables because we are concerned that including such tables could provide information useful in developing adulterants to circumvent the testing process. Moreover, the inclusion of these tables would not clarify for laboratories what they are currently required to report by the HHS Mandatory Guidelines nor would it add to the effectiveness of the MRO verification process. Since the cutoff levels are mandated by the HHS, duplicating them in the rule text does not add any value or streamline the overall procedures required by part 40. Therefore, we have indicated in the rule text that laboratories will be required to use cutoff levels for adulterated and invalid urine specimens that are directed by the HHS.

One commenter stated that an invalid report due to abnormal pH is reported only as “abnormal pH” per HHS direction. For the MRO to find out if it was abnormally high or low, the MRO must contact the laboratory. The commenter suggested that DOT direct laboratories to report either high pH or low pH or the actual pH numbers. This would be consistent with § 40.96(d) which directs laboratories to report the reason a test is invalid and would remove the need for the MRO to call the laboratory on these results.

We agree with the comment that the use of the term abnormal pH creates a requirement for the MRO to contact the laboratory, and we will therefore, direct laboratories to report the actual numerical value for pH.

Finally, one commenter suggested that we clearly point out that the confirmation test is one that uses a different chemical methodology than the initial test on a second aliquot of the specimen. The definition of “confirmatory validity test” clearly states that a confirmation test is performed on a different aliquot of the original specimen.

Laboratories are reporting and MROs are reviewing a variety of test results, including multiple test results for the same testing event. The DOT proposed using categories to make it easier to understand what laboratories and MROs are to report.

Of the commenters who responded to this proposal, some addressed only the question of categories, while others addressed issues related to multiple reporting. Several commenters agreed that understanding the myriad of results is a difficult situation and supported the DOT's attempt to simplify it through the use of identifying categories.

Some concerns centered on the complexities of reporting multiple results of two separate collections from the same collection event. These commenters were troubled about how the overall process would work—for example, if two CCFs were produced on a collection, what would the MRO do with them and how would the MRO report the results? Additionally, the issue of cost per test to the employer was raised and the difficulty of billing with no documentation (i.e., no CCF for the test not reported). In any situation where the tests are reported negative and non-negative—in any order of collection—commenters agreed that the non-negative test should be the result of record reported by the MRO for the testing event. These MRO issues are addressed in the discussion of § 40.162.

Some commenters supported the use of categories and some did not. A number believed that laboratories would not use the categories, but would continue to use specific test results because these are more descriptive and useful. A commenter felt that the terms “negative” and “non-negative” are very simple and descriptive and much more useful than a category list.

The DOT never intended for laboratories to report results as “Category 1” or “Category 2” or “Category 3.” In the NPRM, we merely said that a laboratory's specimen testing result would fall into one of three distinct and separate categories—negative; non-negative; and rejected for testing—and we described them as Categories 1 through 3. We agree with those commenters who said this delineation made it easier for them to understand that the results reported would fall into one of those three categories. Therefore, we will keep the three separate categories for results being reported with the understanding that laboratories are not to report a result as being in a specific category (i.e., Category 1, Category 2, or Category 3; or non-negative), but must report a specific result.

MROs have situations in which neither they nor the employers are able to contact employees to complete the interview process for invalid results. The DOT proposed to modify § 40.133 so that invalids would be handled parallel to part 40's directives on positive, adulterated, and substituted specimens when the employee cannot be interviewed. Four commenters responded to this proposal, and all supported the proposed procedure for resolving invalid test results without interviewing the employee. Based on the comments, the DOT will adopt the proposal in § 40.133 with one modification: To refer to this result as a cancelled test due to an invalid result, instead of a cancelled-invalid.

The DOT made a number of proposals trying to close the potential endless loop of observed collections that could result when the specimen result of a directly observed recollection, following a first invalid (and in some cases, a second or third observed collection), is again invalid.

If the second invalid result was for the same reason as the first invalid, we proposed having the MRO cancel the test. One commenter wished to call this a negative test. The DOT believes it would be inappropriate for the MRO to call this a negative test. Therefore, we will have the MRO cancel the test if the observed recollection is invalid for the same reason as the first invalid. This is consistent with the HHS guidance to MROs. In addition, in § 40.160 (see below), we have provided a way for MROs to obtain negative results for invalids when employees require negative results for pre-employment, return-to-duty, and follow-up testing.

If the second invalid result was for a different reason than the first invalid, the DOT proposed having the MRO verify the result as a refusal to test. We did this to harmonize with the HHS guidance to MROs. We also proposed adding this to the list of refusals at § 40.191.

Many of the commenters said that calling this an automatic refusal to test is problematic—especially if this were allowed without MRO review. The DOT agrees with these commenters. We have decided not to adopt the proposal to add this to the list of refusals at § 40.191. We will consider this an invalid result requiring another immediate recollection under direct observation—and we will not require the MRO to first contact the employee to discuss the result.

The DOT also proposed that when the MRO reports multiple non-negative results and one of them is invalid, the MRO would not be required to report an “invalid result” if the MRO verified any of the other non-negative results—for example, a positive result. A number of commenters supported this proposal, but one did not understand what DOT wanted the MRO to do about the invalid result.

The DOT believes that § 40.159(f) is clear: When the MRO verifies multiple non-negative results and one of them is invalid, the MRO would report all but the invalid result. The invalid result simply will not be reported and the test would not be cancelled because there would actually be at least one reportable non-negative result. For instance, if a laboratory reported a test result as being positive for phencyclidine (PCP) and invalid, the MRO would conduct an MRO review for both the PCP positive and the invalid. The MRO would verify the PCP positive and report it to the employer. Even if the employee had no medical explanation for the invalid result, the MRO would not report it to the employer unless the employee requests to have his or her split specimen tested for PCP and the split fails to reconfirm. The MRO would then cancel both tests, report them to the DER, and direct an immediate recollection under direct observation because the primary specimen had also been invalid. The same would hold true for invalid specimens whose splits failed to reconfirm for adulterants and substitutions.

We also proposed to have MROs contact collection sites to confirm that collectors had properly observed the collections. We agree with the majority of commenters who said that having MROs confirm that collections had been directly observed is labor intensive and of little value, especially if CCFs indicate that observed collections were conducted. Therefore, we will not require the MRO to contact the collector.

Finally, if the employee admits to using drugs to the MRO during the invalid result interview, the MRO must report the admission to the DER for additional action under applicable DOT Agency and United States Coast Guard regulations.

The DOT proposed adding a new § 40.160 to address procedures when a negative result is required but a valid test result cannot be produced because of an individual's legitimate, albeit rare, medical condition.

In such rare circumstances, we will require the MRO to determine if there is clinical evidence that the individual is an illicit drug user. The evaluation requirements in this section will be parallel to existing requirements at § 40.195—when a permanent or long-term medical condition precludes the employee from providing a sufficient amount of urine and a negative result is needed. If the medical evaluation reveals no clinical evidence of drug use, the MRO would report the result to the employer as a negative test with written notations regarding the medical examination. The same procedures would be used when the primary specimen is reported as invalid and the individual has a legitimate medical explanation.

The DOT also requested comments about findings of illicit drug use during these medical evaluations. Currently, a finding of illicit drug use during the medical evaluation under § 40.195 causes the test to be cancelled. We asked for comments on whether the DOT should continue to require cancellation or treat such findings as positive test results.

Most commenters stated that findings of illicit drug use during the medical evaluation should be considered a positive result. Two commenters felt they should be reported as a refusal. One commenter stated that if the examination discloses evidence of current illicit drug use, this should be reported as a positive result. Another commenter was concerned that this evaluation may identify past drug use and may not provide the employee with due process. One commenter stated that a blood test would be far superior to a medical examination in determining evidence of substance abuse.

Although a number of these commenters believe that a finding of illegal drug use during the medical evaluation should be considered a positive or a refusal, the DOT will require that in these cases, MROs will cancel the test, parallel to the existing procedures for insufficient urine in § 40.195. The Omnibus Transportation Employees Testing Act of 1991 provides only one way to determine that an employee has tested positive for illicit drug use—a drug test confirmed by an HHS-certified laboratory using HHS scientific and testing protocols and verified by an MRO. Therefore, we will continue to cancel these results if there are medical signs and symptoms of illicit drug use. The individual will not be able to perform safety-sensitive duties because a negative result is needed. The MROs, under their authority at § 40.327, must continue to report safety and medical qualification concerns to appropriate parties, such as the employer and the physician or health care provider responsible for determining medical qualifications of the employee.

In response to the commenter who thought a blood test far superior to a medical examination for determining substance abuse, we would remind everyone that as part of this medical evaluation, the evaluating physician may conduct other testing to determine whether the employee shows clinical evidence of drug abuse, including, but not limited to, blood testing.

The DOT requested comments to proposed procedures addressing how the MRO would report multiple verified results from one testing event—either multiple results from a single specimen or multiple results from more than one specimen collected during one event. Regarding multiple results from more than one specimen, we asked if it was sensible to require collectors to continue to send two separate specimen collections ( e.g. , a specimen that showed signs of tampering and the subsequent observed collection) to laboratories. In other words, should we continue requiring collectors to send the observed collection but not the specimen that appeared to show signs of tampering?

Most commenters appreciated the fact that DOT had articulated what MROs are to report after verifying multiple results for the same testing event. Some commenters correctly noted some of the problems associated with multiple specimens collected during the same testing event. For example, these multiple specimens pose administrative difficulties: Tying together two collections and two laboratory results and simultaneously reporting the two verified results. In addition, some commenters noted that testing a second specimen imposes additional cost. None of the comments included credible evidence to show that the results of the observed collections were always non-negative.

Therefore, we will continue to require that collectors send both the specimen suspected of adulteration or substitution and the directly observed specimen on for laboratory testing. At § 40.67(f), collectors are already directed to identify and link both specimens in the Remarks section of the CCFs. When the collector follows the required procedures, and the MRO reviews the MRO copies of CCFs before reporting results, the MRO will know that the specimen appeared to show signs of tampering and that specimen is connected to another specimen taken under direct observation. MROs should have procedures in place to identify and connect these linked specimens.

We will modify the section to authorize MROs to “hold” the result of the first laboratory specimen result received if it is negative until the MRO receives the result of a second specimen. If the first result is non-negative, the MRO reports it immediately. The MRO would then follow the required reporting procedures.

The DOT proposed amending § 40.171 to state clearly that there is no split specimen testing for an invalid result. This is consistent with current part 40 split request procedures and with the HHS MRO Manual. Most commenters who responded to this item supported it. We will retain it as written in the NPRM.

These sections concern the DOT's decision to provide authorization for the split laboratory to send the split specimen or an aliquot of it to another HHS-certified laboratory if the split fails to reconfirm the primary specimen's results. The DOT proposed amending §§ 40.177, 40.179, and 40.181 so that a provision currently contained only in § 40.177 for drug testing would be added to the adulterated and substituted split sections. The DOT sought comment on whether providing authorization to the split laboratory would be sufficient, or whether we should require laboratories to send the split specimen or an aliquot.

Several commenters opposed making it mandatory to send the specimen to another laboratory but believed that providing authorization to do so would be sufficient. One commenter wondered if the term “you may” send a specimen to a third laboratory would become “routine” practice and something that all laboratories would then do. This commenter recommended that Laboratory B send the split to a third laboratory only under special circumstances that are documented and have been discussed with the MRO.

The DOT has amended §§ 40.177, 40.179, and 40.181. We continue to authorize the split laboratory to send the split specimen or an aliquot of it to another HHS-certified laboratory to reconfirm the presence of drugs/drug metabolites. We also authorize the same for adulterated specimens. Because the testing procedures for identifying substituted specimens are the same at each laboratory, there would be no reason to send the split to a third laboratory if it failed to reconfirm at a second laboratory.

We will not require a discussion between the MRO and laboratory. The longstanding requirements at § 40.177 on sending the split specimen to another laboratory, which did not make MRO discussion with the laboratory mandatory, have not appeared to cause problems. We agree with the commenter who said that sending split specimens to a third laboratory should not be routine. Therefore, a split specimen should only be sent to a second laboratory when it is likely that doing so will confirm the criteria that were reported in the primary specimen.

Several commenters asked for clarification of § 40.181(b), which stated, “if the test fails to reconfirm the validity criteria reported in the primary specimen, the second laboratory may transmit the specimen or an aliquot to another HHS-certified laboratory that has the capability to conduct another reconfirmation test.” These commenters asked whether “another reconfirmation test” is a requirement to conduct a different, more specific, test method.

With regard to the language proposed in the NPRM at 40.181(b), we are removing the paragraph because all laboratories use the same confirmation methodologies for creatinine and specific gravity.

We intend § 40.179(b) to provide an option for using another laboratory to make it more likely to reconfirm the adulterated criteria reported for the primary specimen. In writing § 40.179(b), we used the language currently at § 40.177 that addresses the use of another laboratory to confirm the split specimen. We are retaining the word “another” in § 40.179(b), to require the second split laboratory to use a different confirmation test than the one used by the first split laboratory. In the case of pH, all laboratories use the same test methodologies, so this would not apply to pH. However, for other adulterants, we think another confirmation test would be suitable if it is likely to confirm the adulteration criteria reported in the primary specimen. If the first split laboratory is unable to confirm the adulteration criteria of the specimen, a second split laboratory, using a different confirmation procedure, may be able to confirm the test result. Therefore, the DOT will retain most of the specific language proposed in the NPRM at § 40.179(b).

The DOT proposed to divide the split results into five distinct categories to make it easier for MROs to understand their responsibilities in cases where they receive any of the more complicated split result possibilities. The majority of commenters supported this proposal. One commenter suggested that these categories would lend themselves to a table.

The DOT will retain the five categories of split results as proposed in the NPRM. We will not include a table, since the description of the five categories in the rule text is specific and self-explanatory.

The DOT did not propose any changes to the employer policy providing the option for recollection of negative-dilute specimens at § 40.197(b)(2), although we added additional rule text to clarify procedures. Several commenters supported this. One commenter suggested that the rules for dilute specimens should be more rigorous. Another commenter suggested that if the DOT believes it appropriate to recollect a negative dilute, the DOT should require that all results of this type be recollected without giving the employer a choice in the matter.

The DOT will not make any changes in this area, other than to revise paragraph § 40.197(c)(3), re-designate paragraph (c)(4) as (c)(5), and add paragraph (c)(4). Negative specimens that are also dilute will continue to be viewed as negative specimens, but with the option for employer policies to determine if there is to be a recollection. This is in keeping with the current regulation for which there have been no significant issues raised.

The DOT proposed changes for splits that are reported as invalid. Commenters who responded to this item supported the proposed rule language. We also proposed changes for a situation in which there is no split laboratory available to test the split specimen. One commenter, an MRO, supported this proposal. We will amend this section by revising paragraphs (c), (d), and (e) and maintain the changes as proposed in the NPRM.

Section 40.207 This section was amended by changing the references in the paragraph.

As proposed, the DOT will modify the semi-annual laboratory report to employers so that it has the same information required by the HHS Mandatory Guidelines. The three proposed changes, while not dramatic, will help laboratories avoid following different report formats for DOT and HHS.

As discussed earlier, we will also add Appendix C requiring laboratories to provide the Department semi-annual data about their DOT-mandated testing.

We will also modify Appendix D to show DOT's new mailing address and electronic-entry address.

DOT will also amend some Appendix F citations to accurately reflect text changes.

The DOT asked a number of other questions related to several issues. Most of these have been addressed in other portions of the preamble. The following issues were not addressed and are discussed below:

We wanted to know if it would be appropriate to require that observers check for realistic-looking prosthetic devices by having employees lower their pants and underwear just before observed collections take place.

Most commenters did not support this proposal on the basis that it was too invasive and that most observers can be trained in ensuring that the urine specimen actually comes from the individual. One commenter indicated that if there is any suspicion during collection, one method that could be used was a one-handed collection (for males) since most devices have a valve that needs to be released and this cannot be done if the donor is holding the collection cup in one hand (with the other hand behind his back).

One association said this proposal would be totally inappropriate since most of their members are female. One TPA and one MRO stated that checks for prosthetic devices should be allowed, but not mandatory, since trained collectors should be expected to know when these checks are needed. Another association supported this proposal and indicated that the Olympic model could be used, where the donors raise their shirts to the chest line and lower their underwear to the knees for initial inspections.

We are also aware that the Omnibus Employee Testing Act of 1991 directed the DOT to utilize procedures that “promoted, to the maximum extent practicable, individual privacy in the collection of specimen samples.” We believe that, with the current proliferation of adulteration products, checking for devices prior to observed collections provide individual privacy “to the maximum extent practicable.” In the early 1990's, adulteration was not a significant problem and the current wide variety of products for adulteration of urine were not available. However, because these products and various mechanical devices are now readily available to individuals who want to adulterate or substitute their urine specimen during a drug testing collection, we believe that the measure of what is the maximum extent of privacy has shifted somewhat. Checking for devices prior to observed collections is the most effective way to ensure the integrity of the testing process while providing individual privacy as much as practicable.

We would also point out that employees who may be required to undergo a directly observed collection have provided reasons to necessitate this procedure by providing specimens that: Showed signs of tampering; were invalid with no legitimate medical explanation for the result; or demonstrated a negative and dilute specimen with creatinine concentration in the 2 to 5 mg/dL range, which made the specimen suspect of adulteration or tampering. Some of these employees may have already violated the testing regulations and are having a return-to-duty or follow-up test.

Based on these facts, the DOT will require employees who are undergoing directly observed collections to raise their shirts, blouses, or dresses/skirts, as appropriate, above the waist and lower their pants and underpants to show the observer, by turning around, that they do not have a prosthetic device on their person. After this is done, they may return their clothing to its proper position and contribute a specimen in such manner that the observer can see the urine exiting directly from the individual into the collection container, as required under current regulations. We will also require direct observation collections for all return-to-duty and follow-up drug tests. We are amending § 40.67 to reflect this procedure and this requirement for return-to-duty and follow-up drug tests.

We also asked for comments regarding the consequence when a realistic-looking prosthetic device is found.

Eight commenters responded. Seven commenters indicated that this should definitely be treated as a refusal to test. One association stated that this should be considered on a case-by-case basis and that the collector should request the donor to remove the device and then proceed with the collection. If the donor fails to remove the device, the collector should document this as a refusal to test.

The DOT agrees with the majority of commenters that the use of realistic-looking prosthetic devices to circumvent the urine specimen collection process is a significant and grievous action, in most cases related to an individual attempting to hide drug use; and it is a deliberate attempt to thwart the testing process. We believe that this action is no different than an individual refusing to cooperate or participate in a specimen collection process. The end result of failure to cooperate is a refusal to test. We believe trying to subvert the collection process using a prosthetic device is as serious an offense and will consider this as a refusal to test. We said so in the July 2006 Questions and Answers guidance; and we will add it to the list in Section 40.191 as constituting a refusing to test.

Also, in the July 2006 Questions and Answers that appear on our Web site, we added to the examples of refusals to test at the collection site an individual refusing to wash his or her hands and an individual admitting to adulterating or substituting a specimen. We will add these two examples to the list in Section 40.191 as constituting a refusal to test. In addition, we will add an employee's refusal to allow the observer to check for devices prior to undergoing an observed collection.

There were 17 comments (some duplicates) that addressed editorial changes and included typographical errors. We appreciate these comments and included most of them.

The statutory authority for this rule derives from the Omnibus Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 45101 et seq. ) and the Department of Transportation Act (49 U.S.C. 322).

This rule has been designated as significant by the Office of Management and Budget for purposes of Executive Order 12866 or the DOT's regulatory policies and procedures, because of potential policy interest to Congress, affected industries, and the public. It is a modification to our overall part 40 procedures and is intended to further align our laboratory and MRO procedures with those requirements that are being directed by HHS. Their economic effects will be very small. Consequently, the DOT certifies, under the Regulatory Flexibility Act, that this rule will not have a significant economic impact on a substantial number of small entities.

In the 2000 part 40 final rule, we estimated that approximately 80% of industry specimens were being tested for SVT and that the costs associated with making SVT mandatory would be about $1.4 million annually—for the 20% that we estimated were not being tested. One commenter misinterpreted our data, thinking that the cost was for testing of the current 80%, and asked for clarification of how the DOT arrived at these figures. Another commenter questioned the accuracy of our more current information, pointing out that at the time the NPRM was published, complete data for 2005 were not available.

The HHS laboratory data for 2006 are available and show the actual number of Federal tests performed was 7.54 million—7.32 million of which were DOT tests. An estimated 98 to 99% of these DOT tests were tested for SVT. The number of tests not being tested for SVT in 2006 is estimated to be 200,000.

A review of laboratory costs for SVT from a number of HHS-certified laboratories indicated an average additional cost of 75 cents to $1.25 per specimen. Using the 2006 data, the cost of SVT would then only increase the cost of DOT-mandated testing by about $200,000. This figure is far less than the $1.4 million amount estimated and approved for SVT in the 2000 final rule. Information on SVT from the DOT Federal employee drug testing program and from another Federal agency's program revealed that they experienced no increased laboratory costs for drug testing when they implemented SVT.

The DOT believes that $200,000 is a reasonable cost for the mandatory SVT and should have minimal impact on employers. In fact, it is far less than the 2000 final rule estimate for mandatory SVT.

Executive Order 12372 requires intergovernmental consultation with state and local officials that would provide the non-Federal funds for, or that would be directly affected by, proposed Federal financial assistance or direct Federal development. The rule would not affect state and local entities in a way that would warrant such consultation.

This rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (2 U.S.C. § 1532).

This rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This notice does not include requirements that (1) has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government, (2) imposes substantial direct compliance costs on State and local governments, or (3) preempts state law. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

This rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13084 (“Consultation and Coordination with Indian Tribal Governments”). Because none of the provisions of the rule would significantly or uniquely affect the communities of the Indian tribal governments or impose substantial direct compliance costs on them, the funding and consultation requirements of Executive Order 13084 do not apply.

DOT invites public comment about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below. We will subsequently publish a Federal Register notice concerning this proposed collection. We would add a requirement that all HHS-certified laboratories provide testing data to the DOT on a semi-annual basis. This is data readily available in laboratory computer systems—information they provide routinely to HHS. They provide similar company-specific information to employers on a semi-annual basis. We estimate that these semi-annual reports to DOT will take a total of six hours for all the laboratories to complete, at a cost of approximately $162 to all laboratories, or less than $4 annually for each laboratory.

On August, 25, 2005, FMCSA published a final HOS rule (“2005 rule”) (70 FR 49978). On July 24, 2007, the DC Circuit Court vacated the 11-hour driving time and 34-hour restart provisions of the 2005 rule ( Owner-Operator Independent Drivers Association, Inc. v. Federal Motor Carrier Safety Administration, 494 F.3d 188 (DC Cir. 2007)). In response to the DC Circuit Court decision, FMCSA published an interim final rule (IFR) on December 17, 2007 (72 FR 71247) that reinstated the two provisions vacated by the Court and sought further comments on those provisions.

For a full background on this rulemaking, please see the preamble to the December 2007 HOS IFR. The docket for this rulemaking (FMCSA-2004-19608) contains all of the background information for this rulemaking, including comments.

This notice advises of the availability of four additional documents. FMCSA remains committed to issuing a final rule in 2008 and any comments on the four documents should be submitted as soon as possible.

FMCSA is placing the following four documents in the docket:

• “Integrated Report: Peer Review of R. J. Hanowski et al. , “Analysis of Risk as a Function of Driving Hours: Assessment of Driving Hours 1 through 11.”” The separate reviews were conducted by D.A. Perrin (January 23, 2008), G. Belenky and L.J. Wu (February 6, 2008), and S.R. Hursh and J. Fanzone (February 7, 2008). This peer review was conducted at the request of FMCSA.

• “Review of Hours of Service Regulatory Impact Analysis (RIA) Report,” conducted by Linda Ng Boyle, Ron Knipling, and Greg Belenky, and dated December 27, 2007. This peer review was conducted at the request of FMCSA.

• “Hours of Service Regulatory Impact Analysis: Peer Review Results and FMCSA Responses,” dated May 2008. This document was prepared in response to the requested peer review of the RIA that accompanied the 2007 HOS IFR.

• “Analysis of Fatigue-Related Large Truck Crashes, the Assignment of Critical Reason, and Other Variables Using the Large Truck Crash Causation Study.” This analysis, dated May 30, 2008, was prepared by FMCSA.

On June 18, 2008, the Board issued Final Rules in the above-docketed proceeding, Regulations Governing Fees for Services Performed in Connection With Licensing Related Services—2008 Update, 73 FR 34649 (June 18, 2008). After the rules were published, an inadvertent error involving the effective dates of the rules was noticed. The effective dates of the final rules are July 18, 2008, rather than June 18, 2008.