This rule is issued under Marketing Agreement and Order No. 925, both as amended (7 CFR part 925), regulating the handling of grapes grown in a designated area of southeastern California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

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

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California grape handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable grapes beginning on January 1, 2007, 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 2007 and subsequent fiscal periods from $0.0175 to $0.0200 per 18-pound lug of grapes.

The California grape 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 California grapes. 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 2005 and subsequent fiscal periods, the committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the committee or other information available to USDA.

The committee met on February 6, 2007, and unanimously recommended expenditures of $160,768 and an assessment rate of $0.0200 per 18-pound lug of grapes for the 2007 fiscal period. In comparison, last year's budgeted expenditures were $131,318. The assessment rate of $0.0200 is $0.0025 higher than the rate currently in effect. The increased assessment rate is needed to permit the committee to fund a research project on Vineyard Mealy Bugs and to ensure that an adequate carryover of reserve funds is available for the 2008 fiscal year.

The major expenditures recommended by the committee for the 2007 fiscal period include $18,000 for research, $5,000 for compliance activities, $109,068 for salaries and payroll expenses, and $28,700 for other expenses. In comparison, budgeted expenses for these items in 2006 were $5,000 for compliance activities, $103,668 for salaries and payroll expenses, and $22,650 for other expenses. The committee did not budget for research projects in 2006.

The assessment rate recommended by the committee was derived by subtracting the committee's total available funds from their anticipated 2007 expenses and dividing the remainder by the estimated 2007 shipments. The total anticipated 2007 expenses are $160,768, and the desired ending reserve is $39,432. The available carry-in funds are $70,000, and the anticipated interest income is $200. The 2007 estimated shipments are 6.5 million 18-pound lugs.

Based on this calculation, (($160,768 + $39,432)−($70,000 + $200)) ÷ 6.5 million = $0.0200, the $0.0200 assessment rate will provide sufficient funds to meet anticipated expenses of $160,768 and will allow for an adequate December 2007 ending reserve of $39,432. Thus, the December 2007 ending reserve will be kept within the maximum permitted by the order, approximately one fiscal period's expenses, as required under 925.41 of the order. It will also be adequate to cover early-season (2008) expenses before assessment income is received.

The assessment rate 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 2007 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

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

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

There are approximately 50 producers of grapes in the production area and approximately 20 handlers subject to regulation under the marketing order. The Small Business Administration (13 CFR 121.201) defines small agricultural producers 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.

Last year, six of the 20 handlers subject to regulation had annual grape sales of at least $6,500,000. In addition, 10 of the 50 producers had annual sales of at least $750,000. Therefore, a majority of handlers and producers may be classified as small entities.

This rule increases the assessment rate established for the committee and collected from handlers for the 2007 and subsequent fiscal periods from $0.0175 to $0.0200 per 18-pound lug of grapes. The committee unanimously recommended expenditures of $160,768 and an assessment rate of $0.0200 per 18-pound lug of grapes for the 2007 fiscal period. The proposed assessment rate of $0.0200 is $0.0025 higher than the 2006 rate. The number of assessable grapes is estimated at 6.5 million 18-pound lugs. Thus, the $0.0200 rate should provide $130,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the committee's authorized carry-in reserve should be adequate to cover budgeted expenses.

The major expenditures recommended by the committee for the 2007 fiscal period include $18,000 for research, $5,000 for compliance activities, $109,068 for salaries and payroll expenses, and $28,700 for other expenses. In comparison, budgeted expenses for these items in 2006 were $5,000 for compliance activities, $103,668 for salaries and payroll expenses, and $22,650 for other expenses. The committee did not budget for research projects in 2006.

The committee reviewed and unanimously recommended 2007 expenditures of $160,768, which included an increase due to a new research project. Prior to arriving at this budget, the committee considered alternative expenditure and assessment rate levels, but ultimately decided that the recommended levels were reasonable to properly administer the order.

The assessment rate recommended by the committee was derived by the following formula: Anticipated expenses ($160,768) plus desired 2007 ending reserve ($39,432), minus the 2007 beginning reserve ($70,000) and the anticipated interest income ($200), divided by total shipments (6.5 million 18-pound lugs), equals the recommended assessment rate ($0.0200 per 18-pound lug).

This rate will provide sufficient funds in combination with interest and reserve funds to meet the anticipated expenses of $160,768 and result in a December 2007 ending reserve of $39,432, which is acceptable to the committee. Thus, the December 2007 ending reserve will be kept within the maximum permitted by the order, approximately one fiscal period's expense, as required under § 925.41 of the order.

A review of historical information and preliminary information pertaining to the 2007 fiscal period indicates that the on-vine grower price for the season could range between $5.00 and $9.00 per 18-pound lug of grapes. Therefore, the estimated assessment revenue for the 2007 fiscal period as a percentage of total grower revenue could range between 0.2 and 0.4 percent.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs will be offset by the benefits derived by the operation of the marketing order.

In addition, the committee's meeting was widely publicized throughout the grape production area and all interested persons were invited to attend the meeting and participate in committee deliberations on all issues. Like all committee meetings, the February 6, 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 California grape 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.

The 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.

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

A proposed rule concerning this action was published in the Federal Register on May 3, 2007 (72 FR 24551). Copies of the proposed rule were provided to all grape handlers, and handlers were invited to submit comments at a California Desert Grape Administrative Committee meeting on May 9, 2007. Finally, the proposal was made available through the Internet by USDA and the Office of the Federal Register. A 30-day comment period ending June 4, 2007, was provided for interested persons to respond to the proposal. No comments were received.

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

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

Pursuant to 5 U.S.C. 553, it also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2007 fiscal period began on January 1, 2007, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable grapes handled during such period; (2) the industry has been shipping grapes since April 2007; (3) the committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (4) handlers are aware of this action which was unanimously recommended by the committee at a public meeting and is similar to other assessment rate actions issued in past years. Also, a 30-day comment period was provided for in the proposed rule.

We anticipate that seats with non-traditional, large, non-metallic panels will be installed in other makes and models of airplanes. We have made the determination to require special conditions for all applications requesting the installation of seats with non-traditional, large, non-metallic panels until the airworthiness requirements can be revised to address this issue. Having the same standards across the range of airplane makes and models will ensure a level playing field for the aviation industry.

On August 8, 2005, Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124, applied for a design change to Type Certificate No. A16WE for installation of seats that include non-traditional, large, non-metallic panels in Boeing Model 737-700 series airplanes. The Boeing Model 737 series airplanes, currently approved under Type Certificate No. A16WE, are swept-wing, conventional-tail, twin-engine, turbofan-powered, single aisle, medium sized transport category airplanes.

The applicable regulations for airplanes currently approved under Type Certificate No. A16WE do not require seats to meet the more stringent flammability standards required of large, non-metallic panels in the cabin interior. At the time the applicable rules were written, seats were designed with a metal frame covered by fabric, not with large, non-metallic panels. Seats also met the then recently adopted standards for flammability of seat cushions. With the seat design being mostly fabric and metal, the contribution to a fire in the cabin had been minimized and was not considered a threat. For these reasons, seats did not need to be tested to heat release and smoke emission requirements.

Seat designs have now evolved to occasionally include non-traditional, large, non-metallic panels. Taken in total, the surface area of these panels is on the same order as the sidewall and overhead stowage bin interior panels. To provide the level of passenger protection intended by the airworthiness standards, these non-traditional, large, non-metallic panels in the cabin must meet the standards of Title 14 Code of Federal Regulations (CFR), part 25, Appendix F, parts IV and V, heat release and smoke emission requirements.

Under the provisions of 14 CFR 21.101, Boeing must show that the Model 737 series airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A16WE, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in Type Certificate No. A16WE are as follows: Title 14 CFR part 25, as amended by Amendment 25-1 through Amendment 25-15, for the Models 737-200, -200C, -300, -400, and -500. Title 14 CFR part 25, as amended by Amendment 25-1 through Amendment 25-77, for the Models 737-600, -700, and -800, with the exceptions listed: Section 25.853(d)(3), Compartment interiors, at Amendment 25-72; and equivalent safety findings, § 25.853(f), Compartment interiors. Title 141 CFR part 25, as amended by Amendment 25-1 through Amendment 25-91, for the Models 737-700C and -900, with the exceptions listed: Section 25.853(d)(3), Compartment interiors, at Amendment 25-72; and equivalent safety findings, § 25.853(f), Compartment interiors. Title 14 CFR part 25, as amended by Amendment 25-1 through Amendment 25-108, for the models 737-900ER, with the exceptions listed: Section 25.853(d)(3), Compartment interiors, at Amendment 25-72; and equivalent safety findings, Section 25.853(f), Compartment interiors.

In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 737 series airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

The FAA issues special conditions as defined in § 11.19, under § 11.38, and they become part of the type certification basis under § 21.101.

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 or similar novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

The Boeing Model 737 series airplanes will incorporate the following novel or unusual design features: These models offer interior arrangements that include passenger seats that incorporate non-traditional, large, non-metallic panels in lieu of the traditional metal frame covered by fabric. The flammability properties of these panels have been shown to significantly affect the survivability of the cabin in the case of fire. These seats are considered a novel design for transport category airplanes that include Amendment 25-61 and Amendment 25-66 in the certification basis, and were not considered when those airworthiness standards were established.

The existing regulations do not provide adequate or appropriate safety standards for seat designs that incorporate non-traditional, large, non-metallic panels in their designs. In order to provide a level of safety that is equivalent to that afforded to the balance of the cabin, additional airworthiness standards, in the form of special conditions, are necessary. These special conditions supplement § 25.853. The requirements contained in these special conditions consist of applying the identical test conditions required of all other large panels in the cabin, to seats with non-traditional, large, non-metallic panels.

A non-traditional, large, non-metallic panel, in this case, is defined as a panel with exposed-surface areas greater than 1.5 square feet installed per seat place. The panel may consist of either a single component or multiple components in a concentrated area. Examples of parts of the seat where these non-traditional panels are installed include, but are not limited to: Seat backs, bottoms and leg/foot rests, kick panels, back shells, credenzas and associated furniture.

Examples of traditional exempted parts of the seat include: Arm caps, armrest close-outs such as end bays and armrest-styled center consoles, food trays, video monitors and shrouds.

“Exposed” is considered to include those panels directly exposed to the passenger cabin in the traditional sense, plus those panels enveloped such as by a dress cover. Traditional fabrics or leathers currently used on seats are excluded from these special conditions. These materials must still comply with § 25.853(a) and § 25.853(c) if used as a covering for a seat cushion, or § 25.853(a) if installed elsewhere on the seat. Non-traditional, large, non-metallic panels covered with traditional fabrics or leathers will be tested without their coverings or covering attachments.

In the early 1980s the FAA conducted extensive research on the effects of post-crash flammability in the passenger cabin. As a result of this research and service experience, we adopted new standards for interior surfaces associated with large surface area parts. Specifically, the rules require measurement of heat release and smoke emission (part 25, Appendix F, parts IV and V) for the affected parts. Heat release has been shown to have a direct correlation with post-crash fire survival time. Materials that comply with the standards (i.e., § 25.853 entitled “Compartment interiors,” as amended by Amendment 25-61 and Amendment 25-66), extend survival time by approximately 2 minutes, over materials that do not comply.

At the time these standards were written, the potential application of the requirements of heat release and smoke emission to seats was explored. The seat frame itself was not a concern because it was primarily made of aluminum and there were only small amounts of non-metallic materials. It was determined that the overall effect on survivability was negligible, whether or not the food trays met the heat release and smoke requirements. The requirements therefore did not address seats. The preambles to both the Notice of Proposed Rule Making (NPRM), Notice No. 85-10 (50 FR 15038, April16, 1985) and the Final Rule at Amendment 25-61 (51 FR 26206, July 21, 1986), specifically note that seats were excluded “because the recently-adopted standards for flammability of seat cushions will greatly inhibit involvement of the seats.”

Subsequently, the Final Rule at Amendment 25-83 (60 FR 6615, March 6, 1995) clarified the definition of minimum panel size: “It is not possible to cite a specific size that will apply in all installations; however, as a general rule, components with exposed-surface areas of one square foot or less may be considered small enough that they do not have to meet the new standards. Components with exposed-surface areas greater than two square feet may be considered large enough that they do have to meet the new standards. Those with exposed-surface areas greater than one square foot, but less than two square feet, must be considered in conjunction with the areas of the cabin in which they are installed before a determination could be made.”

In the late 1990s, the FAA issued Policy Memorandum 97-112-39, Guidance for Flammability Testing of Seat/Console Installations , October 17, 1997 ( http://rgl.faa.gov ). That memo was issued when it became clear that seat designs were evolving to include large non-metallic panels with surface areas that would impact survivability during a cabin fire event, comparable to partitions or galleys. The memo noted that large surface area panels must comply with heat release and smoke emission requirements, even if they were attached to a seat. If the FAA had not issued such policy, seat designs could have been viewed as a loophole to the airworthiness standards that would result in an unacceptable decrease in survivability during a cabin fire event.

In October of 2004, an issue was raised regarding the appropriate flammability standards for passenger seats that incorporated non-traditional, large, non-metallic panels in lieu of the traditional metal covered by fabric. The Seattle Aircraft Certification Office and Transport Standards Staff reviewed this design and determined that it represented the kind and quantity of material that should be required to pass the heat release and smoke emissions requirements. We have determined that special conditions would be promulgated to apply the standards defined in 14 CFR 25.853(d) to seats with large, non-metallic panels in their design.

Notice of proposed special conditions No. 25-06-13-SC, pertaining to Boeing Model 737 series airplanes, was published in the Federal Register on November 9, 2006. Comments were received from Air Tran, Airbus, B/E Aerospace, Boeing, Delta Engineering, the International Coordinating Council of Aerospace Industries Associations (ICCAIA), KLM, and Weber Aircraft LP.

Airbus, Boeing, Delta Engineering, ICCAIA, and Weber suggested that the proposed special conditions were not the appropriate way to establish these requirements. These commenters suggested that either the seat technical standard order (TSO) be revised to include the requirements, or that formal rulemaking activity take place to amend Title 14 CFR part 25.

The commenters stated that including the requirements in either the seat TSO or an amendment to part 25 would ensure that the requirements were applied equally and consistently throughout the FAA and industry. Airbus stated that if the requirements were located in the seat TSO it would reduce the overall administrative burden by requiring a single showing of compliance for a given seat design that may be installed in different types of airplanes.

FAA Response: We believe that including these requirements in the context of special conditions is appropriate. The proliferation of the use of large, non-metallic panels in the construction of seats has created a need to issue special conditions to maintain the current level of safety. Special conditions are the best way of introducing these requirements until we determine it is necessary to amend part 25 through the rulemaking process. Also, seats are not required to follow guidance in a TSO to be eligible for installation on an airplane. Furthermore, the proposed TSO C127b includes these standards as optional criteria.

Air Trans, Boeing, Delta Engineering, ICCAIA, and Weber all suggested that the applicability of the proposed special conditions be expanded and not limited to only Boeing Model 737 series airplanes. The commenters noted that other airplane models certified under 14 CFR part 25 include the same design features identified as “novel or unusual” on Boeing Model 737 series airplanes.

FAA Response: We agree that many other airplane models certified under 14 CFR part 25 include “novel or unusual” design features similar to those on Boeing Model 737 series airplanes. We are developing model-specific special conditions for all transport category airplanes operating under part 121 regulations. We will continue to issue special conditions regarding this subject until part 25 is formally amended through the rulemaking process. If part 25 is amended, these requirements will have general applicability instead of model-specific applicability. We are currently using a similar approach for high intensity radiated fields (HIRF) special conditions. The HIRF special conditions will continue to be issued on a model-specific basis until part 25 is amended to include regulations applicable to HIRF.

Delta Engineering questioned why the proposed special conditions would be applicable to airplanes operated under 14 CFR part 121 and would not be applicable to airplanes operated under 14 CFR part 129. Delta Engineering provided the example of an airplane with a foreign registration. Per the applicability of the proposed special conditions, the requirements of the proposed special conditions would not be applicable because the airplane would be operated in compliance with part 129 operating rules instead of part 121 operating rules.

FAA Response: As discussed previously, our intent in adopting these special conditions is to apply them to airplanes that are already required to comply with the smoke and heat release requirements adopted in Amendment 25-61 and Amendment 25-66. Model 737 airplanes with this amendment in their certification basis * are subject to these special conditions, regardless of the operational regulatory parts under which they are operated. Certain other airplanes operated under part 121 are also subject to these requirements as a result of § 121.312, as amended by Amendment 121-189, even if their certification basis does not include Amendment 25-61. However, airplanes with a certification basis preceding Amendment 25-61 and not subject to § 121.312 are not required to comply either with § 25.853 or with these special conditions.

Air Trans and KLM expressed concern that the requirements in the proposed special conditions would be retroactive and affect the existing airplane fleet or follow-on deliveries of airplanes with previously certified interiors.

FAA Response: We have added a new special condition 4 in these special conditions to clarify that only airplanes associated with new seat certification programs will be affected by the requirements in these special conditions. Previously certificated interiors on the existing airplane fleet and follow-on deliveries of airplanes with previously certificated interiors will not be affected.

Air Tran, B/E Aerospace, and Weber questioned how 1.5 square feet became the maximum area of non-metallic material per seat. B/E stated that the proposed special conditions need further review because the exclusion does not adequately address items traditionally mounted on seat backs. B/E specifically asked if large video monitors would have to comply when installed in seat backs or large, non-metallic panels.

Weber stated that the proposed special conditions include many exclusions based on the size and location of material. Weber also stated that the quantitative limits for these exclusions do not appear to be based on data. Weber suggested that the proposed special conditions be revised to include justification for the quantitative limits. Furthermore, Weber stated that due to the number of passenger places, First Class seats are limited to a much smaller amount of non-compliant material than Tourist Class seats, despite the fact that there are fewer First Class seats per area of the passenger cabin. Larger seats with fewer passenger places should not have lower quantitative limits on non-compliant material.

Weber also stated that, based on observation of airplane cabins and the amount of materials in a seat design, the following statement in the proposed special conditions is incorrect: “Seat designs have now evolved to occasionally include non-traditional, large, non-metallic panels. Taken in total, the surface area of these panels is on the same order as the sidewall and overhead stowage bin interior panels.”

FAA Response: In 1993, the FAA published a report (DODT/FAA/CT-TN93-13) documenting the results of full-scale testing using panels on seats that did, or did not, comply with heat release and smoke emissions requirements. Those test results showed that limited quantities of material on seats that did not meet heat release and smoke emissions requirements did not raise a safety issue. Amendment 25-83 states that, based on this testing, components with exposed-surface areas greater than one square foot, but less than two square feet, must be considered in conjunction with the areas of the cabin in which they are installed before a determination can be made regarding whether or not they have to meet the heat release and smoke density regulations. Based on that information we determined that 1.5 feet of non-metallic material per seat is appropriate.

In response to B/E Aerospace's comment, video monitor installations are not affected by these special conditions. There are existing flammability regulations that cover those installations.

In response to Weber's comment regarding the size limitations, as noted above, we believe that the quantitative limits are justified. These size limitations are consistent with full-scale test data and the design criteria developed at the time Amendment 25-61 was adopted. Also, these size limitations were considered during the rulemaking process for Amendment 25-61.

In response to Weber's comment regarding our statement that the surface areas of some seat installations are equivalent to the amount of material in sidewall and overhead stowage bin interior panels, in our review of applicants' proposed furnishings for passenger cabin installations, we have noticed an increase in the use of large, non-metallic material in proposed seating configurations. Based on those reviews, we believe that our statement is correct.

Boeing noted that the amendment levels for some of the airplanes were incorrectly cited in the Type Certification Basis section of the proposed special conditions.

FAA Response: We have revised the Type Certification Basis section to incorporate Boeing's recommended changes.

B/E Aerospace asked if the non-traditional, large, non-metallic panels covered with traditional fabrics or leathers could be tested without the dress cover. Boeing suggested that the words “or method of covering attachment” be added in the last sentence of the “Clarification of Exposed” paragraph.

FAA Response: We agree to revise the last sentence of the “Clarification of Exposed” paragraph to address B/E Aerospace's question and incorporate Boeing's suggestion. In these special conditions that sentence now states “Non-traditional, large, non-metallic panels covered with traditional fabrics or leathers will be tested without their coverings or covering attachments.”

Airbus requested that the FAA provide information regarding whether or not fabric covered panels are less threatening than thermoplastic ones. No justification was provided for this request.

FAA Response: The standards for using fabric, thermoplastic, and leather have been previously established and are applied separately.

Airbus requested a better description of the console size in the “Definition of ‘Non-Traditional, Large, Non-Metallic Panel ’ ” paragraph of the proposed special conditions. Airbus noted that in the proposed special conditions “Center Consoles” are listed as “traditional exempted areas.” Airbus stated that this may be true for small consoles that “* * * do not protrude the standard seat cushion geometries. However, it is understood that large consoles (which do also divide the forward legroom) are expected to comply with HRR/SD [heat release and smoke density] criteria.” Airbus suggested that this issue should be clarified because FAA Memorandum 97-112-39, Guidance for Flammability Testing of Seat/Console Installations, addresses those larger, separate consoles.

B/E Aerospace stated that the definition of non-traditional areas was not adequate and asked about seat backs, seat bottoms, and kick panels. This commenter also asked if fire blocking material is considered a traditional fabric.

FAA Response: We agree and have revised this paragraph to include “credenzas” as an additional example of non-traditional areas and “armrest-styled center consoles” as an additional example of traditionally exempted areas. In this final special condition the revised sentences appear as follows: “Examples of nontraditional areas include, but are not limited to: seat backs, bottoms and leg/foot rests, kick panels, back shells, credenzas and associated furniture. Examples of traditional exempted areas include: arm caps, armrest close-outs such as end bays and armrest-styled center consoles, food trays, video monitors and shrouds.”

Airbus, Delta Engineering, ICCAIA, and KLM commented that the FAA should conduct additional testing prior to implementing the proposed special conditions. Airbus and KLM provided similar statements that tests with different amounts of non-traditional, large, non-metallic panels on seats have never been performed to evaluate to what extent the increase in the flammability standard of those seat parts might influence fire safety. ICCAIA stated that the FAA should perform testing to confirm the benefit of issuing the proposed special conditions. ICCAIA noted that seat back shells may be made from parts created from a combination of different materials and sizes. As a result, application of the proposed special conditions would result in multiple tests to determine if the seat back shells were compliant, and the test results would be open to interpretation.

Delta Engineering stated that the proposed special condition does not provide information regarding the smoke density and heat release aspects of traditional seat components and that, through testing, the FAA should establish the safety gains related to having the large composite panel compliant with the existing heat release and smoke density requirements. This commenter also stated that the smoke emissions from the seat cushion foam may negate any safety gain related to having the large composite panel compliant with smoke density requirements. In addition, this commenter also questioned whether the FAA conducted extensive testing to confirm that the regulatory standards now being applied to passenger seats are compatible with the requirements in the proposed special conditions.

FAA Response: As stated in the proposed special conditions, the FAA has conducted extensive research on the effects of post-crash flammability in the passenger cabin. As a result of that research, combined with service experience, we adopted new airworthiness standards for interior surfaces associated with large surface area parts. The proliferation of the use of large, non-metallic panels in the construction of seats was not anticipated when those airworthiness standards were issued. This increased use of large, non-metallic panels in seating configurations has created a need to issue special conditions to provide the level of passenger protection intended by those airworthiness standards. Seat cushion standards are a separate consideration and were taken into account when these special conditions were created.

Furthermore, testing is not required to issue special conditions. The basis for issuing special conditions is that the applicable airworthiness regulations do not contain adequate or appropriate safety standards for a “novel or unusual” design feature.

Airbus, B/E Aerospace, ICCAIA, and Weber noted that the proposed special conditions did not include a cost-benefit analysis to support the proposed requirements. Airbus suggested that a cost-benefit analysis should be done through the traditional rulemaking process. ICCAIA stated that the cost-benefit analysis should be conducted because the requirements in the proposed special conditions would be applied to other airplane makes and models. B/E Aerospace and Weber provided similar statements regarding the cost impact to seat manufacturers. Those commenters stated that compliant material is limited and expensive. Weber also stated that significant time and costs would be involved in modifying current designs and developing new materials to comply with the proposed special conditions.

FAA Response: When Amendment 25-61 went through the formal rulemaking process a formal economic regulatory analysis was provided. These special conditions effectively serve to maintain the benefits achieved in that amendment by providing an equivalent level of safety for the novel or unusual design feature described earlier. Under Executive Order 12866, these analyses are required only for rules of general applicability. A cost-benefit analysis is not part of the process for proposing special conditions, which apply only to a specified type certificate and are not rules of general applicability.

Air Trans and Boeing both commented on the effective date of the proposed special conditions. Air Trans stated that the proposed special conditions did not include an effective date. Boeing commented that these proposed special conditions should not be applicable upon publication and should not be applicable to the first delivered Model 737-900ER airplane. Boeing noted that it typically takes at least one year for seat manufacturers to incorporate major design changes, such as those required in the proposed special conditions.

FAA Response: In response to Air Trans' statement, under standard practice, the effective date of final special conditions is 30 days after the date of publication in the Federal Register . These special conditions follow this practice and will be applicable to all type design changes that include new seat approvals applied for after the effective date of these special conditions.

In response to Boeing's comment, as stated previously, the issue regarding large, non-metallic seats is a long standing one and has generated many discussions between the FAA and the aviation industry. Through the Seattle Aircraft Certification Office the FAA has made Boeing aware of the requirements in these special conditions. Since the time the proposed special conditions were published for public comment, the first Boeing Model 737-900ER airplane was delivered; therefore, these special conditions are not applicable to the approved arrangement on that airplane.

Boeing requested that the public comment period for the proposed special conditions be extended from 20 days to 60 days. Boeing stated that the proposed special conditions would require significant design changes to seat components. Airframe and seat manufacturers would need to assess the economic impact of the proposed special conditions and communicate that information to the FAA.

FAA Response: The subject of large, non-metallic seat panels is a long standing issue between the FAA and the aviation industry. We have had ongoing discussions with industry representatives in an effort to work out a solution, and the results of these discussions are reflected in these special conditions. We do not agree that an extension to the public comment period is needed or would result in further changes to these special conditions.

Except as noted above, these special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to Boeing Model 737 series airplanes. Should Boeing apply at a later date for a change to the type certificate to include another model on the same type certificate incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

Seats do not have to meet these special conditions when installed in compartments that are not otherwise required to meet the test requirements of Title 14 CFR part 25, Appendix F, parts IV and V. For example, airplanes that do not have § 25.853, Amendment 25-61 or later, in their certification basis and those airplanes that do not need to comply with the requirements of 14 CFR 121.312.

Only airplanes associated with new certification programs applied for after the effective date of these special conditions will be affected by the requirements in these special conditions. The existing airplane fleet and follow-on deliveries of airplanes with previously certified interiors are not affected.

This action affects only certain novel or unusual design features on Boeing Model 737 series airplanes. It is not a rule of general applicability.

On Friday, June 8, 2007 a final rule for Airspace Docket No. 06-AAL-29, FAA Docket No. FAA-2006-25852, was published in the Federal Register (72 FR 31714). This rule modified Class E Offshore Airspace in southwest Alaska. Several errors were discovered in the Control 1234L Offshore Airspace area description. The first requires further controlled airspace described around the Sand Point Airport. The next is a duplication of the Eareckson Air Force Station description, followed by two incorrect designations for West Longitude. This action corrects these errors.

On June 15, 2007, a final rule for Airspace Docket No. 06-ASW-1, FAA Docket No. FAA-2006-24926 was published in the Federal Register (72 FR 33151), establishing VOR Federal Airway V-65 over the East Central United States. The legal description for V-65 was incorrect in that a reference to the Sandusky, OH, VORTAC was omitted. The correct legal description should contain the words “Sandusky, OH”. This action corrects that error.

Before Commissioners: Joseph T. Kelliher, Chairman; Suedeen G. Kelly, Mark Spitzer, Phillip D. Moeller, and John Wellinghoff.

1. On October 19, 2006, the Federal Energy Regulatory Commission (Commission) issued a Final Rule in Order No. 686 1 amending Part 157, Subpart F, of its regulations to expand the scope and scale of activities that may be undertaken pursuant to blanket certificate authority by (1) broadening the types of natural gas projects permitted under blanket certificate authority to include certain mainline, storage, and liquefied natural gas (LNG) and synthetic gas pipeline facilities, and (2) increasing the blanket certificate project cost limits from $8,200,000 to $9,600,000 for automatic authorization projects and from $22,700,000 to $27,400,000 for prior notice projects. 2 In addition, Order No. 686 clarified that a company is not necessarily engaged in an unduly discriminatory practice if it charges different customers different rates for the same service when customers commit to service on different dates. The revised blanket certificate regulations became effective on January 2, 2007, and are intended to allow interstate natural gas pipelines to employ the streamlined blanket certificate procedures for larger projects and for a wider variety of types of projects, thereby increasing efficiencies, and decreasing time and costs associated with the construction and maintenance of the nation's natural gas infrastructure.

2. In this order, for the reasons discussed below, the Commission grants and denies requests for clarification and denies requests for rehearing of the Final Rule.

3. NiSource Gas Transmission and Storage Companies (NiSource), 3 the National Fuel Gas Supply Corporation (National Fuel), and INGAA submitted timely requests for rehearing and/or clarification. For the reasons discussed below, requests for clarification are granted and denied, as discussed below. Requests for rehearing are denied, with the exception of INGAA's rehearing request with respect to the measurement of compressor noise, which is granted.

4. Section 157.208(f)(2) of the blanket certificate regulations permits natural gas companies to alter the maximum allowable operating pressure (MAOP) of supply or delivery laterals, provided companies comply with the prior notice provisions of § 157.205 of those regulations. NiSource proposes that companies be permitted to rely on blanket certificate authority to change the MAOP of facilities that are not supply or delivery laterals.

5. The Final Rule permits companies to construct compression and loop lines to expand mainline capacity under blanket authority. Consistent with this approach, the Commission clarifies that, provided companies meet all applicable blanket certificate regulatory requirements, they can rely on blanket certificate authority to change the MAOP of facilities that are not supply or delivery laterals, such as mainlines.

6. The Final Rule extends blanket certificate authority to include certain underground storage field projects. National Fuel supports this inclusion, but seeks assurance that storage remediation and maintenance activities that qualify as auxiliary installations or replacements under § 2.55 of the Commission's regulations can still be undertaken pursuant to § 2.55, and need not now proceed under the automatic or prior notice provisions of the blanket certificate program. National Fuel also seeks clarification that plugging and abandoning storage wells constitutes maintenance, and as such will be eligible to be undertaken pursuant to the automatic authorization provisions of § 157.213(a), and will not be viewed as altering the function of a well, which would require adherence to the prior notice requirements of § 157.205(b).

7. The Final Rule's enlargement of the scope of blanket certificate authority does not constrict the scope of activities that may be performed under § 2.55 of the Commission's regulations. Thus, activities involving storage, mainline, and LNG and synthetic gas pipeline facilities that could have been performed under § 2.55 prior to the expansion of the blanket certificate program may continue to be performed under § 2.55. Further, as before, a company need not obtain a blanket certificate as a prerequisite to act under § 2.55.

8. The Commission clarifies that the reference in new § 157.213(a) to altering “the function of any well that is drilled into or is active in the management of the storage facility” is not intended to include temporarily plugging a storage field well as part of standard maintenance operations. In contrast, permanently plugging a well would not qualify as standard maintenance, but would instead constitute an abandonment, as it would permanently alter the function of the well, and could impact the performance of the storage field. Accordingly, such an action would need to comply with the blanket certificate program's § 157.216 regulatory requirements regarding an abandonment.

9. In addition, the Commission will revise §§ 157.213(b) and (c) to permit companies to employ blanket certificate authority to make modifications to storage facilities to enhance injection and withdrawal capacity. This is consistent with the Commission's previously expressed intent to permit a company to rely on expanded blanket certificate authority “to re-engineer an existing storage facility to decrease cushion gas, increase working gas, improve injection and withdrawal capabilities, and add more cycles per season,” provided the company can “demonstrate, by theoretical or empirical evidence, that a proposed project will improve storage operations without altering an underground storage facility's total inventory, reservoir pressure, or reservoir or buffer boundaries, and will comply with environmental and safety provisions.”  4

Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to NADA 141-203 that provides for the addition of a 75-milligram size of DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and inflammation in dogs. The supplemental NADA is approved as of June 13, 2007, and the regulations are amended in 21 CFR 520.538 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640, filed a supplement to NADA 140-974 that provides for use of IVOMEC (ivermectin) Premix for Swine, a Type A medicated article, for the treatment and control of various internal and external parasites. The supplement revises the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine. The supplemental NADA is approved as of June 15, 2007, and the regulations in 21 CFR 558.300 are amended to reflect the approval and a current format.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, for lawful exports, and for maintenance of reserve stocks while deterring the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. The CSA as amended also requires DEA to regulate the manufacture, distribution, import, and export of chemicals that may be used to manufacture controlled substances illegally. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Those classified as List II chemicals may be used to manufacture controlled substances.

On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). The Act amends the CSA by adding new provisions related to the importation, production, and sale of ephedrine, pseudoephedrine, and phenylpropanolamine, their salts, optical isomers, and salts of optical isomers, and products that contain any of the three chemicals.

Ephedrine, pseudoephedrine, and phenylpropanolamine are List I chemicals because each can be the primary ingredient needed to manufacture controlled substances illegally. Ephedrine and pseudoephedrine are primary ingredients important in the illicit manufacture of methamphetamine, a Schedule II controlled substance, and methcathinone, a Schedule I controlled substance; phenylpropanolamine is a primary ingredient important in the illicit manufacture of amphetamine, also a Schedule II controlled substance. Each of the chemicals is also approved as an active pharmaceutical ingredient used in products with legitimate medical purposes. Ephedrine is used in prescription and over-the-counter (OTC) products as a bronchodilator ( e.g. , for treating asthma). Pseudoephedrine, a decongestant, is a common ingredient in both prescription and OTC cold and allergy medications. Research by the National Association of Chain Drug Stores identified approximately 2,500 OTC products that contain pseudoephedrine. The Food and Drug Administration's National Drug Code (NDC) online directory of prescription drugs lists 158 products that contain ephedrine and about 1,250 that contain pseudoephedrine. In November, 2000, the Food and Drug Administration (FDA) issued a public health advisory concerning phenylpropanolamine and requested that all drug companies discontinue marketing products containing phenylpropanolamine due to risk of hemorrhagic stroke. In response, many companies voluntarily reformulated their products to exclude phenylpropanolamine. Subsequently, on December 22, 2005, FDA published a Notice of Proposed Rulemaking (70 FR 75988) proposing to categorize all OTC nasal decongestants and weight control drug products containing phenylpropanolamine preparations as Category II, nonmonograph, i.e., not generally recognized as being safe for human consumption.

Prior to the enactment of CMEA, ephedrine, pseudoephedrine, and phenylpropanolamine were subject to the same requirements as other List I chemicals as they apply to manufacture, non-retail distribution, import, and export. Any person who manufactured the chemical for distribution, distributed, imported, or exported the chemical was required to register with DEA and maintain records on transactions at or above certain threshold quantities. Bulk manufacturers filed annual reports regarding their manufacturing activities with DEA. Importers and exporters had to notify DEA in advance of importations or exportations unless the transaction was between a regulated person and a regular customer abroad or an importation by a regular importer; in that case, the importers and exporters had to notify DEA no later than the date of the transaction. Sales of OTC drug products containing one of the chemicals were subject to sales thresholds above which retail distributors were required to maintain records, but certain forms (blister packs) were generally not subject to control. Mail order sellers of the OTC drugs filed monthly reports. The manufacture, distribution, import, export, and retail sale of prescription products containing the chemicals were not regulated.

The Combat Methamphetamine Epidemic Act of 2005 (CMEA) amends the CSA to tighten controls on the manufacture, distribution, import, export, and retail sale of three List I chemicals—ephedrine, pseudoephedrine, and phenylpropanolamine, and drug products containing them. CMEA imposes the following changes:

• Sales limits apply to retail sales of OTC products. Regulated sellers are required to store the products behind the counter or in locked cabinets and maintain records on each sale, including verifying the name of the purchaser against an approved form of identification supplied by the purchaser. The exemption for blister packs has been removed. Thus, all products sold at retail (except individual sales transactions consisting of a single package of pseudoephedrine where the package contains not more than 60 milligrams) are regulated under the Controlled Substances Act.

• DEA must establish an assessment of the annual needs for estimated medical, scientific, research, and industrial needs of the United States, for lawful exports, and for reserve stocks, for the three chemicals. That assessment will set an upper limit on the quantity of the chemicals and products containing the chemicals that can be produced in or imported to the United States.

• Bulk manufacturers must obtain a manufacturing quota to produce any of the three chemicals.

• Manufacturers who purchase the bulk chemicals to produce products must obtain a procurement quota.

• Importers must obtain a quota to import the chemicals in bulk or in drug products.

• Importers, exporters, brokers, and traders must provide additional information on the persons to whom they intend to sell the chemicals prior to the sale. They must also provide a return declaration, providing actual information regarding the import, export, or international transaction.

Because the mandated changes affect different business activities, DEA is revising its regulations to implement these mandated changes through a series of rulemakings. This Interim Final Rule addresses the CMEA mandate for establishment of an assessment of annual needs and quotas to limit production and importation to those established needs.

CMEA amended the CSA to add ephedrine, pseudoephedrine, and phenylpropanolamine to § 826 of the Act, which requires production quotas for controlled substances. The amendment essentially requires that the three chemicals be treated in the same way as Schedule I and II controlled substances. Under the CSA, DEA must limit the quantity of Schedule I and II controlled substances to that which is necessary to meet the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. DEA establishes the annual needs for each controlled substance, the “aggregate production quota”, and uses that figure to issue manufacturing and procurement quotas. With very limited exceptions, imports of controlled substances are sold to manufacturers (which include repackagers). Because importers can only distribute controlled substances to DEA registrants and manufacturers can purchase only the amount authorized under their procurement quotas, DEA has not needed to issue import quotas to importers. The closed system of control that the CSA mandates for controlled substances means that DEA can track the importation, manufacture, and distribution of controlled substances.

The circumstances for the manufacturing and distribution of the three List I chemicals are different in a number of ways.

• Most of the bulk ephedrine, pseudoephedrine, and phenylpropanolamine used in the United States is imported. DEA is notified of these imports, but until now DEA has not obtained information on the purchasers of the imported chemicals. (DEA has promulgated separate regulations under CMEA that will require importers of all listed chemicals to indicate their downstream customers (72 FR 17401, April 9, 2007).) Although most imported bulk chemicals will be sold to manufacturers, it is possible that some bulk materials could be sold to distributors or exporters.

• Distributors are required to keep records of transactions involving these chemicals, but do not file reports with DEA on distributions.

• Dosage units of OTC drugs containing the chemicals are imported. Although these may be transferred to repackagers or relabelers (who are registered as manufacturers), some may be imported already packaged for retail sale and transferred to distributors or directly to retailers. Retailers may not be DEA registrants.

• Prescription drugs containing one of the chemicals may be imported. Until now, neither the importation, distribution, nor manufacture of these drugs has been subject to DEA regulations.

CMEA amends the CSA by adding ephedrine, pseudoephedrine, and phenylpropanolamine to each of the paragraphs in 21 U.S.C. 826, Production quotas for controlled substances. Section 826 requires DEA to establish total annual needs for each of the three chemicals and to limit manufacturing of the chemicals to the amount needed to provide for medical, scientific, research, and industrial purposes, for lawful exports, and for the maintenance of reserve stocks. In addition, CMEA amends 21 U.S.C. 952 (importation of controlled substances) by adding a new paragraph (d) to cover the importation of the three chemicals; the new paragraph indicates, along with language from the Conference report on CMEA, that Congress expected DEA to establish import quotas for the chemicals:

These sections of the CSA are implemented through a new part, 21 CFR part 1315. Most of the requirements for the assessment of annual national needs and for manufacturing and procurement quotas directly parallel the requirements for controlled substance quotas provided in part 1303.

Under part 1315, bulk manufacturers of the three chemicals will be required to obtain annual manufacturing quotas. A separate quota is required for each chemical. A bulk manufacturer must be registered as a manufacturer to handle the chemical for which quota is applied. A bulk manufacturer must complete and file a DEA Form 189 by April 1 of each year for the following calendar year. The applicant must provide the following information on the form:

• For the current and preceding two years, the actual quantity manufactured, actual net disposals, and actual inventory as of December 31.

• For the next year, the desired quota, the name and registration number of each customer and the amount estimated to be sold to each, and any additional factors the applicant finds relevant to fixing the quota.

Each manufacturer that purchases the chemicals in bulk or in dosage forms will be required to obtain a procurement quota to obtain the bulk chemicals or dosage forms. A separate procurement quota is required for each chemical. The applicant must apply using DEA Form 250. The applicant must provide the following information:

• A statement about the purpose(s) of the requested chemical and the quantity which will be used for each purpose during the next calendar year. The applicant should provide information about the quantities used (acquired, distributed, and inventory) for the current and preceding 2 calendar years.

• If the purpose is to manufacture dosage forms, the applicant must state the official name, common or usual name, chemical name, or brand name of that dosage form, and must include the strength.

• The company must state the type of activity intended: product development, repackaging, relabeling, manufacturing OTC finished product, manufacturing prescription finished product.

• If the purpose is to manufacture a controlled substance listed in Schedule I or II or another List I chemical, the applicant must state the quantity of the other substance or chemical that the applicant has applied to manufacture under § 1303.22 and the quantity of the first chemical needed to manufacture a specified unit of the second chemical.

DEA notes that the above requirements are consistent with existing requirements for controlled substances quotas found in 21 CFR Part 1303.

DEA recognizes that applicants may not have complete data on inventories and records for previous years because DEA has not required registrants to keep these records. Most manufacturers of OTC products should have the information in the records they maintain on regulated transactions. Applicants who manufacture prescription products may not have full records for the initial filings. DEA notes that the provision of incomplete information as part of an application for quota in the initial year of implementation of quotas for ephedrine, pseudoephedrine, and phenylpropanolamine may not, in and of itself, prevent an applicant from obtaining quota. DEA has significant experience regarding the processing of quota applications for which incomplete information is present at the initial establishment of quota (e.g., a new formulation of a controlled substance). DEA will work with quota applicants to obtain information that could be used in the processing of the applicant's initial application.

To track and control the quantity of each of the chemicals and drug products containing the chemicals, DEA must limit imports to a quantity consistent with the national needs. CMEA amended 21 U.S.C. 952(a) to state that “It shall be unlawful to import * * * ephedrine, pseudoephedrine, and phenylpropanolamine * * * except that such amounts of * * * ephedrine, pseudoephedrine, and phenylpropanolamine as the Attorney General [DEA by delegation] finds necessary to provide for the medical, scientific, or other legitimate purposes * * *.” Importers will be required to obtain an import quota for each chemical covering both bulk chemicals and dosage forms. Importers will be required to submit an application that includes the following information:

• The type of product (bulk chemical or finished forms to be transferred to a manufacturer or product to be sold for distribution).

• The quantity of each type of product.

• For the previous two years, the name, address, and DEA registration number (if applicable) of each customer and the amount sold; inventory as of December 31 for each form of the product ( i.e. , bulk chemical, in-process material, or finished dosage form); and acquisitions (imports).

DEA recognizes that importers handling prescription products may not have historical records for their initial filings. If an importer is handling prescription drug products, it is possible that some of its customers may not be DEA registrants. DEA notes that the provision of incomplete information as part of an application for quota in the initial year of implementation of quotas for ephedrine, pseudoephedrine, and phenylpropanolamine may not, in and of itself, prevent an applicant from obtaining quota. DEA has significant experience regarding the processing of quota applications for which incomplete information is present at the initial establishment of quota ( e.g. , a new formulation of a controlled substance). DEA will work with quota applicants to obtain information that could be used in the processing of the applicant's initial application.

Depending on the activities that a firm engages in, a firm may have to apply for multiple quotas. For example, a firm that imports ephedrine to bulk manufacture pseudoephedrine would need to obtain an import quota and a procurement quota for ephedrine and a manufacturing quota for pseudoephedrine. A manufacturer that imports bulk ephedrine and pseudoephedrine to produce dosage units of drugs containing the chemicals would need to obtain separate import and procurement quotas for each chemical.

DEA will use the information filed in support of the quota applications as one factor in the determination of an initial assessment of annual needs for each of the chemicals to ensure that the United States has sufficient quantities to meet medical, scientific, research, industrial, exportation, and reserve stock needs. DEA will publish its assessment by May 1 and then revise the assessment based on comments and further information before publishing a final assessment for the following year. The assessment establishes a ceiling on domestic manufacturing and importation of these chemicals. DEA may, at its discretion, seek additional information from applicants if needed to determine an appropriate level for the annual assessment ceiling. For example, because repackagers and relabelers handle products that are covered by other procurement or import quotas, DEA may need more details on customers from those seeking procurement quotas to ensure that it is not double counting quantities. This issue may arise particularly in reference to OTC products, where a manufacturer may produce dosage units that are repackaged or relabeled to be sold under multiple store brand labels.

DEA is adopting the same process for manufacturing and procurement quotas for the three chemicals as it currently applies to those quotas for controlled substances. Manufacturers may apply for increases in their manufacturing quotas; DEA may reduce individual manufacturing quotas to prevent the total amount produced from exceeding the assessment of annual needs. Manufacturers may abandon their quota by notifying DEA.

Manufacturers holding a procurement quota may apply for adjustment of the quota by applying to DEA with a statement indicating the need for an adjustment. Any manufacturer who holds a procurement quota must, before giving an order to another manufacturer or importer requiring the distribution of a covered chemical, certify in writing that the quantity being ordered does not exceed the unused portion of the person's procurement quota for the year. The certification must be signed by someone who is authorized to sign a DEA registration application.

As specified in the CMEA amendment to section 952 of the CSA, importers may apply for an increase in their quota and DEA may approve the application if DEA determines that the increase is needed to meet medical, scientific, or other legitimate purposes. For changes in the import quota, DEA will approve or deny the application within 60 days of receiving the application; if DEA does not reach a decision within the 60 days, the application is considered to be approved until DEA notifies the applicant in writing that the approval is terminated.

DEA may hold hearings, at the Administrator's sole discretion, to obtain factual evidence regarding the assessment of national needs. Applicants or quota holders may request hearings on the issuance, adjustment, suspension, or denial of a quota. In hearings on the assessment of national needs, each interested party has the burden of proving any proposition of facts or law that the party asserts. At hearings on the issuance, adjustment, suspension, or denial of a quota, DEA has the burden of proving that the requirements for issuance, adjustment, suspension, or denial of a quota are met.

DEA is amending DEA Form 189 (application for a manufacturing quota) and DEA Form 250 (application for a procurement quota). DEA Form 189 is being amended to include the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine; adding a field to supply an e-mail address; and adding a field requesting information regarding the authority by which a product may be marketed under the Federal Food, Drug and Cosmetic Act ( e.g. , NDA number or FDA monograph). DEA is soliciting comments on this provision. DEA included this requirement in the application to assist in making its determination that the quota would be utilized for “medical” purposes. However, DEA notes that there are instances in which applications may not fall within this category ( e.g. , quota used to support bona fide scientific research, industrial uses and product development efforts). DEA will consider applications for quota to support these activities even though the applicant would not be able to complete this portion of the application.

DEA Form 250 is being amended to include the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine; adding a field to supply an e-mail address; permitting the use of List I Chemical Code Numbers as well as the DEA Drug Code numbers; and adding a field requesting information regarding the authority by which a product may be marketed under the Federal Food, Drug, and Cosmetic Act ( e.g. , NDA number or FDA monograph). DEA is soliciting comments on this provision. DEA included this requirement in the application to assist in making its determination that the quota would be utilized for “medical purposes.” However, DEA notes that there are instances in which applications may not fall within this category ( e.g. , quota used to support bona fide scientific research, industrial uses and product development efforts). DEA will consider applications for quota to support these activities even though the applicant would not be able to complete this portion of the application.

In addition, DEA has developed a new DEA Form 488 for applying for an import quota.

CMEA amended 21 U.S.C. 844 to make it unlawful for a person to knowingly purchase at retail more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product in a 30-day period and further stated that no more than 7.5 grams of the 9 grams of each chemical may be imported by means of shipping through a private or commercial carrier or the Postal Service. Imports for personal use below these quantities are not subject to import quota requirements. Any person who wishes to import more than 7.5 grams of each of the chemicals in a 30-day period would have to register as an importer and obtain an import quota.

DEA is amending the definition of “regulated transaction”, found in 21 CFR § 1300.02, to reference new part 1315.

Subpart A of new part 1315 provides general information about part 1315. Section 1315.01 defines the scope of part 1315.

Section 1315.02 provides definitions. The definition of “net disposal,” which is in § 1300.01 and applies to controlled substances, is included here for the three List I chemicals. The final paragraph repeats the statutory provisions that each of the three chemicals includes their salts, optical isomers, and salts of optical isomers.

Section 1315.03 provides the personal use exemption from importer registration, import declaration, and import quotas.

Section 1315.05 specifies the persons to whom the part applies.

Subpart B, Sections 1315.11 and 1315.13 describe the process for determining the assessment of annual needs for each of the three chemicals and adjusting the assessment. The sections parallel §§ 1303.11 and 1303.13.

Subpart C, Sections 1315.21 through 1315.27 cover the requirements for individual manufacturing quotas. The sections are taken from §§ 1303.21 through 1303.27.

Subpart D addresses procurement and import quotas. Section 1315.30 describes what procurement and import quotas authorize and serves as an introduction to the requirements for these quotas.

Section 1315.32 specifies the requirements for obtaining a procurement quota and is based on § 1303.12.

Section 1315.34 covers the requirements for obtaining an import quota. The section specifies the information that an applicant must submit and indicates that DEA may request additional information, if necessary.

Section 1315.36 specifies the procedures for amending an import quota, as provided in 21 U.S.C. § 952(d).

Subpart E, §§ 1315.50 through 1315.62 cover the procedures for hearings on the assessment of annual needs and the issuance, adjustment, suspension, or denial of a quota. These sections are based on §§ 1303.31 through 1303.37.

The Administrative Procedure Act (APA) generally requires that agencies, prior to issuing a new rule, publish a notice of proposed rulemaking in the Federal Register . The APA also provides, however, that agencies may be excepted from this requirement when “the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B).

With publication of this Interim Final Rule, DEA is invoking this “good cause” exception to the APA's notice requirement based on the combination of several extraordinary factors. The Combat Methamphetamine Epidemic Act of 2005 specifically amended 21 U.S.C. 826 to mandate the establishment of production quotas for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DEA has no discretion in this requirement and is essentially creating the same system of production quotas for these three List I chemicals as is currently established for controlled substances in Schedules I and II. These regulations address the procedures for the implementation of these quotas, and DEA has endeavored to use existing procedures wherever possible for simplicity and ease of implementation.

Further, the CMEA amended 21 U.S.C. 952 to prohibit all importation of ephedrine, pseudoephedrine, and phenylpropanolamine except such amounts as the Attorney General finds to be necessary for medical, scientific, or other legitimate purposes. The Act further amended § 952 regarding import quotas for these three List I chemicals.

In a separate rulemaking, DEA implemented the retail provisions of the CMEA (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), which included, among others:

These provisions limit the availability of scheduled listed chemical products at the retail level. While these products will be available for purchase, their diversion to the illicit production of methamphetamine will be more difficult due to the sales limits, logbook requirements, and other provisions. Congress, in crafting CMEA, recognized that limiting of product availability at the retail level could potentially encourage diversion of either drug products or the List I chemicals themselves higher in the supply chain—at the import, manufacture, and distribution levels. To address its concern about “what immediately moves in behind,” (Rep. Souder, February 28, 2006, CR p. 423) Congress included provisions in CMEA to control the import, export, manufacture, and distribution of the three chemicals and products containing them. These provisions also will make it possible for the United States to meet the recommendations of the International Narcotics Control Board, which encouraged its member countries to provide for pre-export notifications and an assessment of legitimate need for these chemicals.

In a separate rulemaking (72 FR 17401, April 9, 2007) DEA implemented the “spot market” provisions of the CMEA related to the importation, exportation, and international transactions involving all listed chemicals. The provisions of section 716 of the CMEA implemented by that rulemaking require importers, exporters, brokers, and traders to notify DEA, before the transaction is to take place, of certain information regarding the transferee(s) (downstream customer(s)) and the listed chemicals to be transferred. Such information provides DEA with an opportunity to evaluate the transaction.

DEA must implement the quota provisions of the CMEA on an interim basis to ensure that product upstream from the retail level is not diverted for illicit purposes. It would be contrary to the public interest to allow the diversion of large amounts of ephedrine, pseudoephedrine, and phenylpropanolamine at the wholesale level while implementing controls at the retail level to limit sales of these very products.

The CMEA, as evidenced by the number of rulemakings DEA is issuing to implement it, sets forth a complex array of statutory requirements, with different effective dates, designed to prevent the use of certain List I chemicals in the illicit manufacture of methamphetamine and amphetamine. In addition, the CMEA, which, among other things, essentially reclassifies ephedrine, pseudoephedrine, and phenylpropanolamine as scheduled listed chemicals, imposes new retail restrictions on these products, and mandates new domestic and import quotas, is expansive in its breadth. The broad scope of the new law, as well as the expedited effective dates, is a clear reflection of Congress' concern about the nation's growing methamphetamine epidemic and its desire to act quickly to prevent further illicit use of these chemicals.

The retail and “spot market” provisions of the CMEA, which DEA has already implemented through separate rulemakings, limit the sale of ephedrine, pseudoephedrine, and phenylpropanolamine at retail and provide information to DEA regarding downstream customers of United States importers, exporters, brokers and traders. They do not, however, provide controls at the distribution, manufacturing, and importing levels of the distribution chain. To fully implement the CMEA as intended by Congress, and to work to combat the methamphetamine epidemic the United States is currently experiencing, DEA must utilize all tools at its disposal to control the importation, exportation, manufacture, and retail sale of ephedrine, pseudoephedrine, phenylpropanolamine, and products containing those three List I chemicals.

In light of these factors, DEA finds that “good cause” exists to issue this interim rule without engaging in traditional notice and comment rulemaking. In so doing, DEA recognizes that exceptions to the APA's notice and comment procedures are to be “narrowly construed and only reluctantly countenanced.” Am. Fed'n of Gov't Employees v. Block , 655 F2d 1153, 1156 (DC Cir. 1981) (quoting New Jersey Dep't of Envtl. Prot. v. EPA , 626 F.2d 1038, 1045 (DC Cir. 1980)). Based on the totality of the circumstances associated with the CMEA, DEA finds that invocation of the “good cause” exception is justified.

Under section 553(d) of the APA, DEA must generally provide a 30-day delayed effective date for final rules. DEA may dispense with the 30-day delayed effective date requirement “for good cause found and published with the rule.” DEA believes that good cause exists to make this rule effective upon publication. As DEA noted previously, rulemakings have already been implemented to limit the availability of scheduled listed chemical products at the retail level. The limiting of product availability at the retail level could potentially encourage diversion of either drug products or the List I chemicals themselves higher in the supply chain—at the import, manufacture, and distribution levels. Congress included provisions in CMEA to address this circumstance, and the quota provisions set forth in this rulemaking work toward that goal. DEA must implement the quota provisions of the CMEA upon publication to ensure that product upstream from the retail level is not diverted for illicit purposes.

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 605(b)). The RFA applies only to proposed rules that are subject to notice and comment (5 U.S.C. 601(2)). Because this rule is codifying statutory provisions, DEA has determined, as explained above, that public notice and comment are not necessary. Consequently, the RFA does not apply.

DEA has nonetheless considered the impact of the rule on small entities. As discussed below, DEA estimates that about 310 firms in the manufacturing and wholesale sectors will be affected by this rule. About 250 of these may be small entities under the Small Business Administration definitions of small entities. For most of these firms the impact of the rule will be very small; they will be required to file an annual request for import or procurement quotas. DEA estimates that the cost of applying for a quota is about $96 for importers and $113 for manufacturers, which includes data collection and mailing. These costs do not represent a significant economic impact even on the smallest repackagers whose average revenues are above $54,000. The average revenues of the smallest firms in sectors subject to the rule for which the 2002 Economic Census has data are shown in Table 1.

The larger impact of the rule will be in any reduction in sales that results from limits imposed by a firm's quotas. Only one firm manufactures bulk pseudoephedrine in the United States. This firm is owned by an Indian chemical manufacturer and is not a small entity. The rest of the firms affected by the rule can be divided into three sectors:

• Importers and manufacturers of prescription products containing the chemicals.

• Importers and manufacturers of OTC products that are sold primarily through drug stores, grocery stores, discount department stores, superstores, and electronic mail order houses.

• Importers and manufacturers of OTC products that are sold almost exclusively through independent convenience stores or other small outlets.

The three sectors will be affected differently by the quotas. DEA will provide importers and manufacturers of prescription products with the quantities that they request unless DEA has some reason to believe that the prescription product is being diverted. These firms will not have a significant economic impact from the rule.

Importers and manufacturers of OTC products that are sold through conventional outlets are likely to receive the quotas requested adjusted only to account for general estimates of diversion and declines in demand. At this point, DEA has not estimated the adjustment needed to account for diversion, but expects that it will be small relative to the declines in demand that are resulting from the retail sales restrictions. As DEA has discussed in the retail rule (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), most of the firms that manufacture these products for sales in conventional outlets also manufacture the substitutes. DEA does not expect that these firms will see a significant economic impact from the quotas, but is seeking comment on this issue.

DEA anticipates that the third sector will be more severely affected. This sector is comprised of a small number of companies that import or manufacture products in higher dosages than are normally purchased through conventional outlets and sell the product almost exclusively through nonconventional outlets, such as independent convenience stores, liquor stores, etc. Although some products sold mainly in drug stores, grocery stores, and large discount or warehouse stores are stolen or bought for illicit purposes, DEA's experience indicates that products sold almost exclusively through nonconventional outlets are far more likely to be diverted in substantial quantities. In investigations, DEA has found some of these stores selling products in quantities 20 to 40 times what such stores would be expected to sell to meet legitimate needs. Many of these manufacturers have, in the past, marketed products in packages that are no longer legal for retail sales because they contain more than 3.6 grams of the chemical. DEA has issued multiple warning letters to these manufacturers to inform them of the diversion of their products.

An application for a quota from these manufacturers of products sold primarily or exclusively through such outlets or from importers who sell to these manufacturers will be reviewed using the same standards used to review other applications for a quota. However, DEA notes that the agency has published many final orders in the Federal Register addressing the distribution of these products sold almost exclusively to nonconventional outlets, and has found that a significant percentage of such products have been diverted. DEA will consider the historical uses of such products when determining whether the quantities requested in a quota application are required to meet the legitimate needs of the market. Consequently, if the manufacturers of these products, and the importers supplying those manufacturers, request quotas that are consistent with a past pattern of known diversion, these firms may not receive quotas in the amounts requested. It is also possible that the number of outlets carrying their products will decline if these stores decide that CMEA requirements for retail sales are too onerous. Some of these firms may experience a significant economic impact, particularly if this product line generated a substantial portion of their sales. Some of these firms appear, based on their web sites, to have added substitutes to their product lines; others appear to have dropped the product line altogether. DEA is seeking comments on this issue.

The Deputy Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). It has been determined that this is “a significant regulatory action.” Therefore, this action has been reviewed by the Office of Management and Budget.

Regulated Entities. The firms subject to this rule are manufacturers and importers. At present, only one firm in the United States manufactures any of these chemicals in bulk and, therefore, only that firm will have to apply for a manufacturing quota. DEA reviewed a list of pseudoephedrine OTC and prescription products and ephedrine prescription products and identified about 240 firms based on their labeler codes. Each of these firms, plus any firms that repackage or relabel, will need to obtain procurement quotas. Based on 2005 DEA data, DEA estimates that about 69 firms with 91 locations are currently registered to import the chemicals; these firms will need to obtain import quotas if they are actually importing the chemicals. Although 91 locations are registered to import these chemicals, import notices indicate that many of these locations do not handle the chemicals. If other firms import prescription drug products that contain the chemicals they will also have to obtain import quotas. Based on these data, DEA estimates that 332 locations may apply for quotas if the demand for the chemicals and drug products remains the same (1 bulk manufacturer, 240 manufacturers, and 91 importers). Table 2 presents the number of potential applicants by sector. Registrants must apply for quotas for each registered location rather than by firm. Consequently, the number of manufacturing locations applying may be higher than listed if the firms handle the product at multiple locations. The importers are, in some cases, also manufacturers so that the total number of affected firms may be reduced. The total number of importer registrants includes firms with multiple registered locations.

Costs. As detailed in the Regulatory Flexibility Act section, there will be some burden associated with applying for quotas. DEA estimates that the total cost of the quota application process will be about $35,880 a year.

As noted above, the larger cost of this rule is likely to be based on the extent to which the quotas constrain the market for OTC products containing ephedrine or pseudoephedrine. DEA assumes that the quotas will not affect the prescription drug market. DEA will establish its assessment of annual national needs for each of the chemicals, which will serve as a ceiling on the quantities for which quotas are granted. In setting an assessment of annual national need, DEA will consider the likelihood that OTC sales of scheduled listed chemical products may be reduced by the new restrictions on retail sales. Domestic demand for these products comes from three sources:

• Legitimate medical, scientific, and industrial needs and maintenance of reserve stocks.

• Exports.

• Illicit use-clandestine methamphetamine/amphetamine laboratories.

As DEA discussed in its Interim Final Rule on retail sales of scheduled listed chemical products (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), DEA has no reliable information on the value of the OTC market for these products. Estimates range from $250 million to $1.5 billion annually prior to the sales restrictions. The effect of State laws restricting sales and of the anticipation of the CMEA restrictions appear to be reducing the market considerably, at least for imports of bulk materials. Data from the U.S. International Trade Commission on the change in the imports from January through August of 2006 over the same period in 2005 are shown in Table 3.

DEA is requesting comments and data from importers and manufacturers about the change in their markets and its impact.

DEA notes that the figures in Table 3 reflect imports for both prescription and OTC drugs. Because DEA does not anticipate that quotas will have any effect on prescription drugs, it is likely that the decline in the retail market is considerable. However, even the highest estimate of the market pre-restriction indicates that the total cost of quota restrictions will be less than $100 million in any one year, the standard for an economically significant rule. If the highest estimate of the value of the market, $1.5 billion, were to remain unchanged after retail restrictions, quotas would have to restrict that market by 6.67 percent to reach the $100 million a year level. If, as is far more likely, the market is declining significantly absent the quotas, the quotas would have to restrict the market by more than 10 percent to reach the level of economically significant under the Executive Order. At this time, DEA does not believe that the level of diversion is 6.67 percent of sales on a national basis. Therefore, DEA does not consider that this rule will have a significant economic impact. DEA requests comments on this issue.

Benefits. Congress, in CMEA, imposed a set of requirements on the manufacture, import, and sale of the three chemicals. These requirements, taken together, are intended to limit production and sales of these chemicals to that needed for legitimate purposes. The reduction in demand for these chemicals that is already occurring will limit the world production and make less available for diversion on the international market. In terms of societal accounting, the principal benefit of quotas that constrain supply will stem from a reduction in diversion to domestic illicit production of methamphetamine and amphetamine. The reduced volume of diversion will cause a reduction in the number of domestic clandestine methamphetamine laboratories and domestic illicit production of methamphetamine. Constrained supply is expected to raise the price of the chemicals in the domestic market and, for the clandestine methamphetamine laboratories, increase the cost and difficulty of obtaining them. The constrained-supply effect will come from the retail restrictions as well as from the quota ceiling; it is difficult to make separate quantitative estimates of the results of these two causes.

Reduction in the number of clandestine methamphetamine laboratories reduces costs to Federal, State, and local governments of raiding these clandestine operations and cleaning up pollution at clandestine methamphetamine laboratory sites. As DEA detailed in its rule on retail sales (specifically 71 FR 56020, September 26, 2006), DEA, the States, and local governments spent more than $17 million in clean up costs in FY 2005. This cost covers only the removal of chemicals that could be reused from clandestine laboratory sites; the cost of cleaning up soil or property contamination is paid by the land owner, but if the owner cannot pay the cost, local governments bear the burden or the contamination remains. The costs also do not cover the time State and local governments spend investigating, arresting, and trying clandestine laboratory operators or the social costs related to children and others exposed to hazardous chemicals at these laboratories.

DEA is revising two information collections currently approved under the Paperwork Reduction Act of 1998, and establishing a new information collection to address new mandates established by the CMEA. The two information collections being revised are OMB approval number 1117-0006: “Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine” (DEA Form 189), and OMB approval number 1117-0008: “Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine” (DEA Form 250). DEA is revising these collections by slightly revising the forms and increasing the estimated annual number of respondents and responses. Those changes have been discussed above, and are necessary for DEA to implement the provisions of the Combat Methamphetamine Epidemic Act of 2005. DEA is also establishing a new information collection: “Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine” (DEA Form 488).

The Department of Justice, Drug Enforcement Administration, has submitted the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with review procedures of the Paperwork Reduction Act of 1995. The proposed information collections are published to obtain comments from the public and affected agencies.

All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the information collection instrument with instructions, should be directed to Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537.

Written comments and suggestions from the public and affected agencies concerning the collections of information are encouraged. Your comments on the information collection-related aspects of this rule should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Overview of information collection OMB 1117-0006:

(1) Type of Information Collection: revision of an existing collection.

(2) Title of the Form/Collection: Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine.

(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:

Form Number: DEA Form 189.

Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.

(4) Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: business or other for-profit.

Other: none.

Abstract: 21 U.S.C. 826 and 21 CFR 1303.22 and 1315.22 require that any person who is registered to manufacture any basic class of controlled substances listed in Schedule I or II and who desires to manufacture a quantity of such class, or who desires to manufacture using the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine, must apply on DEA Form 189 for a manufacturing quota for such quantity of such class or List I chemical.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: Only one firm currently manufactures these chemicals in the United States so only one additional firm will need to file this form. DEA estimates that each form takes 0.5 hours (30 minutes) to complete. Therefore, the burden increase for this one firm associated with this rulemaking is 0.5 hours annually.

(6) An estimate of the total public burden (in hours) associated with the collection:

One individual respondent will spend 0.5 hours (30 minutes) annually completing this form for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This results in an annual public burden of 0.5 hours.

This form is already used to collect information regarding controlled substances quotas. For that aspect of this collection, 36 respondents submit 297 responses annually, for a public burden of 148.5 hours annually. DEA notes that the controlled substances aspect of this collection is not being adjusted or revised.

Therefore, in total, 37 firms take 0.5 hours (30 minutes) each to complete the form. This results in a total public burden of 149 hours annually.

Overview of information collection OMB 1117-0008:

(1) Type of Information Collection: revision of an existing collection.

(2) Title of the Form/Collection: Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine.

(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:

Form Number: DEA Form 250, Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.

(4) Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: business or other for-profit.

Other: none.

Abstract: 21 U.S.C. 826 and 21 CFR 1303.12 and 1315.32 require that U.S. companies who desire to use any basic class of controlled substances listed in Schedule I or II or the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for purposes of manufacturing during the next calendar year shall apply on DEA Form 250 for procurement quota for such class or List I chemical.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: DEA estimates that each form takes 1 hour to complete. DEA estimates that 240 individual respondents will respond to this form.

(6) An estimate of the total public burden (in hours) associated with the collection: 240 individual respondents will spend one hour annually completing this form for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. This results in an annual public burden of 240 hours.

This form is already used to collect information regarding controlled substances quotas. For that aspect of this collection, 255 respondents submit 1,106 responses annually, for a public burden of 1,106 hours annually. DEA notes that the controlled substances aspect of this collection is not being adjusted or revised.

Therefore, the total public burden for this collection is 1,346 hours annually.

Overview of new information collection:

(1) Type of Information Collection: new collection.

(2) Title of the Form/Collection: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine.

(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:

Form Number: DEA Form 488, Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.

(4) Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: business or other for-profit.

Other: none.

Abstract: 21 U.S.C. 952 and 21 CFR 1315.34 require that persons who desire to import the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine during the next calendar year shall apply on DEA Form 488 for import quota for such List I chemicals.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: DEA estimates that 91 individual respondents will apply for import quotas. DEA estimates that each response will take one hour.

(6) An estimate of the total public burden (in hours) associated with the collection: DEA estimates that this collection will involve 91 annual public burden hours.

If additional information is required, contact: Lynn Bryant, Department Clearance Officer, Information Management and Security Staff, Justice Management Division, Department of Justice, Patrick Henry Building, Suite 1600, 601 D Street NW., Washington, DC 20530.

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

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

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

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

The Coast Guard will be enforcing the permanent special local regulations in 33 CFR 100.901 (published July 13, 1989, in the Federal Register , 54 FR 29547, as amended), for marine events in the Captain of the Port Detroit Zone during June and July, 2007. The following special local regulations will be enforced for marine events occurring in June and July, 2007:

(1) International Bay City River Roar , Bay City, MI. Location: That portion of the Saginaw River from the Liberty Bridge on the north to the Veteran's Memorial Bridge on the south, near Bay City, MI on June 22-24, 2007 from 8 a.m. to 6 p.m. each day. If an additional day is needed for this event due to inclement weather, the special local regulations will also be enforced on June 25, 2007 from 8 a.m. to 6 p.m.

(2) International Freedom Festival Tug Across the River , Detroit, MI. Location: That portion of the Detroit River bounded on the south by the International boundary, on the west by 083° 03′W, on the east by 083° 02′W, and on the North by the U.S. shoreline on July 15, 2007 from 12:30 p.m. to 2:30 p.m.

(3) Bay City Fireworks Display , Bay City, MI. Location: Saginaw River, from the Veteran's Memorial Bridge to approximately 1,000 yards south to the River Walk Pier, near Bay City, MI on July 1-3, 2007 from 10 p.m. to 11 p.m. each night. If an additional day is needed for this event due to inclement weather, the special local regulations will also be enforced on July 4, 2007 from 10 p.m. to 11 p.m.

(4) Detroit APBA Gold Cup Race , Detroit, MI. Location: Detroit River, between Belle Isle and the U.S. shoreline, near Detroit, MI. Bound on the west by the Belle Isle Bridge and on the east by a north-south line drawn through the Waterworks Intake Crib Light (LLNR 1022) on July 13-15, 2007 from 7 a.m. to 7 p.m. each day.

This notice is issued under authority of 33 CFR 100.901 and 5 U.S.C. 552(a).

International Customized Mail (ICM) agreements are specialized, mailer-specific, agreements entered into by the Postal Service which provide discounted rates from the base rates for existing categories and services of international mail. Postal Service regulations published at IMM 297 require that routine notices be published within prescribed periods identifying the salient terms of each ICM. In particular, information required to be published about each ICM include extensive information about each ICM. In particular, information required to be published about each ICM include extensive information about each ICM, including the term, type of mail involved, destination country or countries, description of services provided by the Postal Service, minimum volume commitments for each service, brief descriptions of any work-sharing performed by the mailer, and the agreed-upon rate for each service at the volume level committed by the mailer.

The underlying rationale for this final rule is based on recently enacted amendments to the Postal Service's organic statute. On December 20, 2006, the Postal Accountability and Enhancement Act (PAEA), Pub. L. No. 109-435, became law. The PAEA fundamentally changes the Postal Service's business model by converting former requirements to operate on a break-even basis to a more commercial, profit-making business model. The PAEA further gives the Postal Service considerable flexibility in pricing competitive services. In addition, the PAEA makes various commercial laws, such as antitrust, Federal Trade Commission unfair competition law, and private sector customs requirements, as well as an assumed federal income tax applicable to the Postal Service's competitive services.

Under the PAEA, bulk international mail, which includes bulk mailings entered in combination with an ICM, could reasonably be classified as falling within the “competitive” category of mail, for which there are abundant, alternative providers. Thus, competitive services should observe commercial business practices. In general, private businesses do not publicize information about recently executed customer agreements; rather, such instruments are regarded as closely held commercial information. Consequently, in accordance with industry practice, continued publication of comprehensive information about the terms of ICMs would be inconsistent with their competitive status.

Hence, the Postal Service is publishing this final rule to provide an appropriate level of information about each ICM in view of their commercial sensitivity.

We adopt the following changes to the Mailing Standards of the United States Postal Service, International Mail Manual (IMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 20.1.

I. Purpose of Rulemaking

On October 28, 2004, the President signed the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Pub. L. 108-375 (codified as amended in scattered sections of 42 U.S.C.). Division C, Subtitle E, of this Act includes amendments to the Energy Employees Occupational Illness Compensation Program Act of 2000 (“EEOICPA”), 42 U.S.C. 7384-7385. Several of these amendments, under § 3166(b), established new statutory requirements under 42 U.S.C. 7384q and 7384l(14)(C)(ii) that pertain to the Department of Health and Human Services (“HHS”) procedures established under 42 CFR part 83: “Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.” These new requirements included the following: (1) Following the receipt of a petition for designation as members of the Special Exposure Cohort (“the Cohort”), the National Institute for Occupational Safety and Health (NIOSH) must submit “a recommendation” on that petition, including all documentation, to the Advisory Board on Radiation and Worker Health (“the Board”) within 180 days; (2) following the receipt by the Secretary of HHS (“the Secretary”) of a recommendation by the Board that the Secretary determine in the affirmative that a class meets the statutory criteria for addition to the Cohort, the Secretary must submit to Congress a determination as to whether or not the class meets these statutory criteria within 30 days; (3) if the Secretary does not submit this determination to Congress within 30 days, then on the 31st day it shall be deemed that the Secretary has submitted a report to Congress that designates, as an addition to the Cohort, the class recommended by the Board for addition to the Cohort and that provides the criteria used to support the designation; and (4) the period Congress shall have to review a report submitted by the Secretary to designate a class as an addition to the Cohort is reduced from 180 days to 30 days.

The purpose of the new requirements was to expedite the evaluation and decision process for adding classes of employees to the Cohort.

On December 22, 2005, HHS issued an Interim Final Rule (IFR) incorporating changes to ensure the new statutory requirements are met and requesting public comment (70 FR 75950). The public comment period for this rulemaking was initially to close on February 21, 2006. Upon a request from the Board for additional time to comment, the comment period was extended for 30 days and closed on March 23, 2006, after a total of 90 days.

As discussed below, HHS has incorporated additional changes in this Final Rule in response to comments from the Board and from the public. These changes also bring the Final Rule into alignment with the Congressional recommendations specified in the Conference Report associated with the new statutory deadlines (H. Rep. 108-767).

The public comment period for the IFR extended from December 22, 2005 through March 23, 2006. HHS received comments from seven parties in addition to the consensus comments of the Board. These include four individuals, one U.S. Senator, one labor organization, and one advocacy group. The comments are summarized and responded to below, together with explanations of changes HHS has incorporated into this Final Rule.

Several commenters, including the Board, recommended that HHS reiterate in the final rule NIOSH's 180-day statutory deadline to evaluate a petition and submit recommendations to the Board. One commenter also wanted the rule to specify what actions HHS would take if NIOSH failed to meet that deadline. In contrast, another commenter recommended against including any of the statutory deadlines in the rule because of concern that hastening the evaluation and recommendation process could prevent the full and fair consideration of petitions.

Commenters also raised concerns about various aspects of the IFR's petition qualification and review process. Several commenters were concerned that the rule did not include within the 180-day statutory deadline NIOSH's process for identifying deficiencies in petitions. They said the FY05 Defense Act Conference Report (H.Rep. 108-767) indicated that Congress intended for the qualification process to be included within the 180-day period, citing the following from the Report:

Most commenters, including the Board, also recommended that HHS reinstate the 30-day period for petitioners to request a review of NIOSH's proposed finding that a petition is deficient and does not qualify for consideration. Finally, one commenter recommended that HHS clarify in the rule that NIOSH will provide a recommendation for each class of employees the petition covers.

In response to those comments, HHS has made several changes in the final rule. First, HHS has added a reference to the 180-day deadline for NIOSH to evaluate petitions and submit recommendations to the Board (§ 83.13 (e)). The provisions in the IFR were designed to ensure that NIOSH would meet the deadline. Referencing the 180-day deadline in the final rule identifies the goal that the earlier changes are intended to achieve.

Second, HHS has revised the rule so the process of determining whether petitions are qualified is included in the 180-day period (§§ 83.5(k) and 83.11). HHS agrees with the commenters that Congress intended to include that process in the 180-day period, and the change brings the final rule into alignment with the Conference Report.

As the commenters pointed out, the IFR did not include this process in the 180-day period. In the preamble to the IFR, HHS said it was necessary to exclude the process from the deadline to ensure that NIOSH had adequate time to evaluate petitions and make recommendations within the deadline. According to NIOSH, sometimes it can take months to assist and consult with petitioners to help them remedy petition deficiencies, which could significantly impact NIOSH's ability to do a comprehensive evaluation before the deadline ended. Thus, in the IFR HHS distinguished between “submissions” ( i.e. , petitions that were not yet determined to meet the requirements of §§ 83.7-83.9) and “petitions” ( i.e. , petitions that have been determined to meet the requirements) (§ 83.5(k)). The 180-day period started tolling only when NIOSH received a “petition” (§ 83.5(k)). In the final rule, HHS has deleted § 83.5(k) and removed the distinction between submissions and petitions in § 83.11.

Third, HHS has reinstated the 30-day period for petitioners to request a review of NIOSH's proposed finding that a petition is deficient (§ 83.11). In the IFR, HHS had reduced the request period to 7 days to increase the feasibility of NIOSH meeting the 180-day deadline. To ensure that the additional time for requesting review does not prevent NIOSH from meeting the deadline, HHS is adopting the recommendation of one commenter that the clock on the 180 days start when petitioners seek and are granted a review on whether their petition satisfies all requirements. Accordingly, HHS has added new paragraph (e) to § 83.13 specifying that the 180-day period shall not include any days during which (1) the petitioner is revising the petition to remedy deficiencies NIOSH identified, (2) the petitioner requests a review of NIOSH's proposed finding that the petition does not meet all relevant requirements, or (3) the three-person HHS panel (as authorized by § 83.11(d)) is reviewing the petitioner's request.

Finally, HHS has revised § 83.13(d)(4) to clarify that NIOSH evaluation report findings to the Board must specify whether it is “feasible” to estimate radiation doses with sufficient accuracy “for each class defined in the report.” HHS is adding this specification because NIOSH sometimes finds a Cohort petition covers more than one class of employees even though it is submitted on behalf of a single class. For example, in some cases, NIOSH will find differences in radiation exposures and record availability for different employee groups at the same facility. Consequently, NIOSH evaluation reports may need to define more than one class of employees in the petition and provide separate findings concerning each class. In light of NIOSH's 180-day deadline, HHS has also added language to paragraph (d)(4) indicating that NIOSH's evaluation report must include a feasibility finding about whether radiation doses for each class of employees can be estimated with sufficient accuracy.

HHS did not adopt every recommendation commenters made. HHS has not incorporated recommendations that NIOSH inform petitioners of all deficiencies within the first 30 days (H. Rep. 108-767). HHS believes the recommendation is not necessary. The changes in the final rule specifying that the 180-day period begins when NIOSH receives a petition gives the Agency more than adequate incentive to identify very quickly whether the petition qualifies for consideration or has deficiencies.

Also, HHS has not adopted the recommendation to add requirements to the final rule specifying the actions HHS would take if NIOSH failed to meet the 180-day deadline. HHS fully understands the EEOICPA statutory amendments stressing the importance of evaluating petitions in a timely manner. Although there may be complex circumstances of radiation exposure or records availability or exceptional instances when it may be challenging to complete a comprehensive evaluation covering all of the classes of employees included in petition within 180 days, HHS will make every effort to meet the deadline. The NIOSH Web page at http:www.cdc.gov/NIOSH/ocas will continuously track the progress of each active petition for the interested public.

Two commenters indicated confusion concerning whether a petitioner could submit a petition on behalf of a class of employees subsequent to NIOSH finding that a prior petition covering the class did not meet the petition requirements. The commenters believed that § 83.11(f) only permitted NIOSH, upon its own discretion, to consider a petition for a class of employees for which a prior petition had already been found to not meet petition requirements.

Nothing in the rule would prevent a petitioner from submitting a subsequent petition based on new information. Such a petition would be evaluated by NIOSH as a new petition. HHS has amended § 83.11, adding paragraph (g), to clarify that petitioners may submit an additional petition for a class of employees, based on new information, subsequent to NIOSH finding that a petition does not meet the petition requirements specified in §§ 83.7—83.9.

The existing paragraph (f) of § 83.11 has a different purpose. It is intended to allow NIOSH to reconsider a petition that it found to not meet petition requirements, based on new information NIOSH might obtain from any source, irrespective of any further action of the petitioner.

One commenter recommended that HHS regulate the current policy of the Board that requires the Chair to submit recommendations of the Board on the outcome of Cohort petitions to the Secretary within 21 days of the Board's consensus formulation and approval of the recommendations.

HHS has not incorporated this Board policy into the rule. Doing so would violate the Administrative Procedure Act (“APA”) rulemaking procedures specified in 5 U.S.C. 553 for the development of regulations. The APA requires that the regulating agency both provide the public with the opportunity for notice and comment and consider submitted comments prior to promulgation of a final rule. The change proposed by the commenter is not a reasonably foreseeable outcome of the changes discussed in the IFR and making such a change would not offer the public adequate notice of the change.

Furthermore, HHS does not consider it necessary or appropriate to regulate this currently self-imposed policy of the Board. It is within the Board's prerogative, with the guidance of the Designated Federal Official, to set and manage its own deadlines.

One commenter recommended HHS reinstate the opportunity for petitioners to seek reviews of the proposed decisions on the outcome of petitions, issued by the Director of NIOSH under § 83.16(a), prior to the issuance of final decisions by the Secretary of HHS.

As discussed in the preamble of the IFR (70 FR 75950, December 22, 2005), it is not possible for petitioners to seek and HHS to provide an administrative review of the proposed decision, and for the Secretary to issue a final decision, all within the 30-day Congressional report deadline. For this reason, the administrative review opportunity of petitioners was preserved but moved in the sequence of HHS actions to follow, rather than precede, the Secretary's final decision.

Another commenter questioned whether the Secretary has discretion in responding to an HHS administrative review of a final decision and whether petitioners must seek such an administrative review as a prerequisite to obtaining a judicial review of a final decision of the Secretary issued under § 83.17.

Under § 83.18(c), the Secretary retains the discretion to decide the outcome of a petition, after obtaining and considering the information provided by the HHS administrative review. The authority to decide the outcome of petitions was statutorily assigned to the President (42 U.S.C. 7384q) and delegated to the Secretary by Executive Order 13179.

The Secretary's decision to add or deny adding a class to the Cohort is final unless he revises the decision pursuant to an administrative review under § 83.18 or Congress takes other action. This administrative review is optional; neither EEOICPA nor this regulation requires it as a prerequisite to judicial review.

One commenter recommended requiring that NIOSH disclose the identities and contact information of petitioners. The commenter reasoned that since the petitioner is acting on behalf of a class of employees, the petitioner should not have the right to privacy.

The IFR did not propose imposing such a requirement on NIOSH or petitioners in this Final Rule. Instead, HHS would first have to provide public notice, the opportunity for public comment, and consideration of comments submitted, as required for rulemaking under the APA.

Moreover, the recommendation to require petitioners or NIOSH to disclose the identity and contact information of the petitioners is contrary to the customary protection afforded by the Federal government to members of the public under the Privacy Act (5 U.S.C. 552a). In particular, 5 U.S.C. 552a(b) bars agencies (subject to certain exceptions not applicable here) from disclosing records such as those at issue in the recommendation, where petitioner information is “contained in a system of records” that allows retrieval of such records by unique person-specific identifiers, “to any person, or to another agency” without the individual's written request or prior written consent.

In addition, there does not appear to be a substantial justification or benefit to requiring the disclosure of the identity and contact information of the petitioner. A petitioner should not have to choose between acting on his or her own behalf, as a member or a survivor of a member of the class of employees represented in the petition, and his or her right to privacy. It is true that the class of employees includes other individuals who would also benefit from an affirmative decision on the petition by the Secretary, but any other member of the class of employees covered by the petition can obtain the same rights as the petitioner by submitting a valid petition, meeting the requirements specified under §§ 83.7-83.9, on behalf of the same class of employees.

Two commenters appeared to have misunderstood the statutory requirement that the President render a decision regarding the addition of a class of employees to the Cohort within 30 days of the Board having recommended its addition ( see 42 U.S.C. 7384q(c)(2)(A)-(B)) to newly authorize the President's involvement in these decisions. One commenter recommended that the President not be given the role of making such decisions, and the second commenter recommended that the President not be provided 30 days to make such decisions, as the commenter believed this would prolong the decision-making process.

Since EEOICPA was originally enacted in 2000, the President has been solely authorized in the statute to decide whether or not to designate classes of employees for addition to the Cohort. The President delegated this authority to the Secretary, who has implemented this authority ever since. The only change made by the statutory requirement discussed above is to impose a 30-day deadline on the President to make such decisions in certain cases. As discussed in the IFR, this 30-day deadline applies to the Secretary's decisions, since the President delegated this decision-making authority to the Secretary. The deadline does not prolong the decision-making process since, prior to this statutory requirement, the Secretary was not under any deadline to make such decisions.

HHS received several comments that do not pertain to the IFR. These included a comment to add a class of employees from the Hanford facility to the Cohort, a personal perspective on the history of the management of the U.S. nuclear weapons program, concerns about the involvement of the Office of Management and Budget (“OMB”) in the program, and a speculation that adding classes of employees to the Cohort would be cost-saving compared to the conduct of dose reconstructions.

The Board recommended NIOSH provide petitioners with guidance in the form of a timeline for the petition process, to ensure petitioners understand the expected duration of the entire process and its elements, from the submission of a petition to the point at which final decisions on a petition become effective. NIOSH will provide each petitioner with such guidance, together with other introductory materials provided to petitioners upon the receipt by NIOSH of a petition.

One commenter suggested all cancers be added to the list of 22 “specified cancers” covered for members of the Cohort. The list of specified cancers covered for members of the Cohort is established statutorily under EEOICPA and not governed by this rulemaking. EEOICPA states:

The term “specified cancer” means any of the following:

(A) A specified disease, as that term is defined in section 4(b)(2) of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note).

(B) Bone cancer.

(C) Renal cancers.

(D) Leukemia (other than chronic lymphocytic leukemia), if initial occupational exposure occurred before 21 years of age and onset occurred more than two years after initial occupational exposure. 42 U.S.C. 7384l(17)

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the agency must determine whether a regulatory action is “significant” and therefore subject to review by OMB and the requirements of the Executive Order. Under section 3(f), the order defines a “significant regulatory action” as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as “economically significant”); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the executive order.

This rule is being treated as a “significant regulatory action” within the meaning of the executive order because it meets the criterion of Section 3(f)(4) in that it raises novel or legal policy issues arising out of the legal mandate established by EEOICPA. It amends current procedures by which the Secretary considers petitions to add classes of employees to the Cohort to comport with new statutory deadlines ( see 42 U.S.C. 7384q(c)(2)(A) and 42 U.S.C. 7384l(14)(C)(ii)). The revisions, however, neither affect the financial cost to the federal government of responding to these petitions nor the scientific and policy bases for making decisions on such petitions.

The rule carefully explains the manner in which the procedures are consistent with the mandates of 42 U.S.C. 7384q and 7384l(14)(C)(ii) and implements the detailed requirements of these sections. The rule does not interfere with State, local, and tribal governments in the exercise of their governmental functions.

The rule is not considered economically significant, as defined in § 3(f)(1) of Executive Order 12866. As discussed above, it does not affect the financial cost to the federal government of responding to these petitions nor does it affect the scientific and policy bases for making decisions on such petitions. Furthermore, it has a subordinate role in the adjudication of claims under EEOICPA, serving as one element of an adjudication process administered by the Department of Labor (“DOL”) under 20 CFR parts 1 and 30. DOL has determined that its rule fulfills the requirements of Executive Order 12866 and provides estimates of the aggregate cost of benefits and administrative expenses of implementing EEOICPA under its rule ( see 71 FR 78520, December 29, 2006). OMB has reviewed this rule for consistency with the President's priorities and the principles set forth in Executive Order 12866.

The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601 et. seq. , requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for-profit organizations. HHS certifies that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. The rule affects only HHS, DOL, the Department of Energy, and certain individuals covered by EEOICPA. Therefore, a regulatory flexibility analysis as provided for under RFA is not required.

The Paperwork Reduction Act (“PRA”) 44 U.S.C. 3501 et seq. , requires an agency to invite public comment on and to obtain OMB approval of any regulation that requires ten or more people to report information to the agency or to keep certain records. The Special Exposure Cohort rule, 42 CFR part 83, which requires the collection of information from petitioners, is covered by the PRA and has received OMB clearance (OMB control #0920-0639). However, this rulemaking, which makes limited changes to 42 CFR part 83, does not contain any information collection requirements. Thus, HHS has determined that the PRA does not apply to this rulemaking.

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), HHS will report to Congress promulgation of this rule prior to its taking effect. The report will state that HHS has concluded that this rule is not a “major rule” because it is not likely to result in an annual effect on the economy of $100 million or more. However, this rule has a subordinate role in the adjudication of claims under EEOICPA, serving as one element of an adjudication process administered by DOL under 20 CFR parts 1 and 30. DOL has determined that its rule is a “major rule” because it will likely result in an annual effect on the economy of $100 million or more.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq. ) directs agencies to assess the effects of federal regulatory actions on State, local, and tribal governments and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this rule does not include any federal mandate that may result in increased annual expenditures in excess of $100 million by state, local or tribal governments in the aggregate, or by the private sector.

This rule has been drafted and reviewed in accordance with Executive Order 12988 on Civil Justice Reform and will not unduly burden the federal court system. HHS adverse decisions may be reviewed in United States District Courts pursuant to the APA. HHS has attempted to minimize that burden by providing petitioners an opportunity to seek administrative review of adverse decisions. HHS has provided a clear legal standard it will apply in considering petitions. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

HHS has reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.”

In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this rule on children. HHS has determined that the rule would have no effect on children.

In accordance with Executive Order 13211, HHS has evaluated the effects of this rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect on them.

The Secretary has determined, pursuant to 5 U.S.C. 553(d)(3), that there is good cause for this rule to be effective immediately to eliminate legal inconsistencies between new statutory requirements under 42 U.S.C. 7384 l and 7384q and regulatory requirements under 42 CFR part 83 and to make the implementation of the new statutory requirements feasible.

In October 2002, the U.S. Fish and Wildlife Service (Service or we) received a petition signed by 25 members of Congress representing the Great Lakes region to add silver, bighead, and black carp to the list of injurious wildlife under the Lacey Act (18 U.S.C. 42). A follow-up letter to the original petition had seven additional Legislator signatures that supported the petition.

The Service published a Federal Register notice of inquiry on silver carp (68 FR 43482-43483, July 23, 2003), and provided a 60-day public comment period. We received 31 comments in total, but 12 of these did not address the issues raised in the notice of inquiry. We considered the information provided in the 19 relevant comments.

Most of the comments supported the addition of silver carp to the list of injurious wildlife, but provided no additional information. One commenter noted that silver carp have no commercial value, but was concerned that listing would hinder control and management. One commenter asked us to delay listing until a risk assessment could be completed. Biological synopses and risk assessments were completed for silver and largescale silver carp. A proposed rule to add all forms of live silver and largescale silver carp to the list of injurious fishes under the Lacey Act was published on September 5, 2006 (71 FR 52305); the comment period on the proposed rule closed on November 6, 2006. We received 97 comments on the proposed rule. In total, the Service received 116 pertinent letters during the public comment periods. Most of the 116 letters received urged the Service to list silver and largescale silver carp as injurious wildlife, but provided no additional information. Similar comments were grouped into issues; these issues and our responses to each are presented below.

Issue: One commenter stated that there is currently no market for silver carp; very few silver carp are in culture (for maintenance of stocks) or use. However, there is great potential for silver carp use in aquaculture within Arkansas and Mississippi by utilizing an enclosed system that would prevent escape of silver carp. The potential for silver carp use in the United States has not been fully realized.

Response: This rule will prohibit the importation and interstate transport of live silver carp, gametes, viable eggs, and hybrids, which will in no way affect the use of silver carp in States where they already exist.

Issue: One aquaculture industry group stated that there is no meaningful role of silver carp in cleaning ponds and tanks for southern U.S. aquaculture producers and that there would be little or no economic impact associated with this rule. However, they also noted that the natural invasion of silver carp will continue into waters of other States, whether the proposed rule is enacted or not. The comment stated that, given the existing conditions and circumstances of silver carp, listing these species will do little or nothing to address the problems stated in the proposed rule. Listing would not address the real problem of preventing the spread of naturally occurring populations; States already have the authority to address these problems, so Federal intervention does not seem necessary.

Response: The Service agrees that this rulemaking will not address the ecological impacts of silver carp already in the environment. This rulemaking is intended to prevent or delay the introduction of silver carp into waterbodies where they do not currently exist, which will help protect native species. Many States have requested Federal intervention because the States only have authority to regulate possession within State boundaries.

Issue: A few commenters stated that they did not understand why nine questions were included in the proposed rule. These commenters believe that asking those questions has delayed the rulemaking. In addition, they expressed concern with the length of time it takes to add species to the list of injurious wildlife.

Response: Nine questions were included in the proposed rule in order to ascertain if there were any additional data pertinent to the analyses required by various laws and executive orders relating to the Federal rulemaking process. Inclusion of these nine questions has in no way delayed the process of adding silver and largescale silver carp to the list of injurious wildlife.

Issue: One commenter stated that the proposed rule contained repetition of unnecessary facts and that many assumptions were made without scientific research.

Response: The Service has reviewed the proposed rule to reduce repetition in the final rule. Research has been conducted on silver carp impacts and due to the similarities between silver carp and largescale silver carp, we feel that reasonable extrapolations of potential impacts have been made.

Issue: A few commenters stated that penalties for injurious wildlife should be increased.

Response: Penalties for violations of the Lacey Act are set by Congress.

We asked scientists who have knowledge of fisheries biology or invasive species to provide peer review of the proposed rule during the public comment period. The peer reviewers had a few technical comments and suggestions; however, all concluded that the data and analyses used in the proposed rule were appropriate and the conclusions drawn were clear and concise. Additionally, peer reviewers provided additional documentation of potential impacts to native species. This information has been incorporated into the final rule.

The regulations contained in 50 CFR part 16 implement the Lacey Act (18 U.S.C. 42) as amended. Under the terms of the injurious wildlife provisions of the Lacey Act, the Secretary of the Interior is authorized to prohibit the importation and interstate transportation of species designated by the Secretary as injurious. Injurious wildlife are those species, offspring, and eggs that are injurious to wildlife or wildlife resources, to human beings, or to the interests of forestry, horticulture, or agriculture of the United States. Wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, and reptiles are the only organisms that can be added to the injurious wildlife list. The lists of injurious wildlife are at 50 CFR 16.11-16.15.

By adding all forms of live silver carp and largescale silver carp, including hybrids, to the list of injurious wildlife, their importation into, or transportation between, States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States by any means whatsoever is prohibited, except by permit for zoological, educational, medical, or scientific purposes (in accordance with permit regulations at 50 CFR 16.22), or by Federal agencies without a permit solely for their own use. Federal agencies who wish to import silver carp or largescale silver carp for their own use must file a written declaration with the District Director of Customs and the U.S. Fish and Wildlife Service Inspector at the port of entry. No live silver carp or largescale silver carp, progeny thereof, viable eggs, or hybrids imported or transported under permit may be sold, donated, traded, loaned, or transferred to any other person or institution unless such person or institution has a permit issued by the U.S. Fish and Wildlife Service. The interstate transportation of any live silver carp or largescale silver carp, gametes, viable eggs, or hybrids currently held in the United States for any purpose is prohibited without a permit. Any regulation pertaining to the possession or use of silver carp and largescale silver carp within States continues to be the responsibility of each State.

The commonly named silver carp belongs to the family Cyprinidae, with the species name of Hypophthalmichthys molitrix. Silver carp are native to Asia (China and Eastern Siberia), from about 54 °N southward to 21 °N. Silver carp are primarily phytoplanktivores, but are highly opportunistic, eating phytoplankton, zooplankton, bacteria, and detritus. Silver carp are well established throughout much of the Mississippi River Basin, and its range is expanding in that basin.

The commonly named largescale silver carp (or southern silver carp or Vietnamese carp) also belongs to the family Cyprinidae, with the species name of Hypophthalmichthys harmandi. Largescale silver carp are native to fresh waters of northern Hainan Island, China, and the Red (Hong Ha) River of northern Vietnam from subtropical to tropical (21-22 °N). The species does not occur naturally on the Chinese mainland. Largescale silver carp feed on phytoplankton and prefer slow-moving, plankton-rich open waters. There is no indication that this species has been imported into or introduced into the open waters of United States.

For additional information on the biology, use, history and pathways of introduction into the United States for silver and largescale silver carp, please refer to the proposed rule published in the Federal Register on September 5, 2006 (71 FR 52305).

The major pathway for introduction of silver carp in the United States was importation for biological control of plankton in aquaculture ponds and sewage lagoons. The pathway that led to the presence of this species in open waters of the United States was likely escape from these facilities. Subsequent escapes and the mixture of silver carp with other species that were stocked likely contributed to the expansion of the species' range, along with natural reproduction.

Other probable pathways that may aid the spread of existing populations of silver carp include connected waterways, contamination of pond-grown baitfishes with silver carp, ballast water release, release or escape from livehaulers that support commercial fisheries, or spread by commercial fishers themselves.

Silver carp are difficult to handle and transport because of their propensity to jump when disturbed. As a result, there has been very little culture of silver carp in the United States since 1985, and they are not being cultured commercially at this time. However, should culture of silver carp resume, a potential pathway for introduction would be escape or release from a facility or during the transport and sale of live fish in retail markets.

Silver carp are likely to be spread when juveniles are collected by cast net for use as live baitfish. Silver carp juveniles are very similar in appearance to shad, and anglers sometimes catch young silver carp and use them as live bait. Release of live bait has been identified as a source for more than 100 introductions of fishes beyond their natural range in the United States. Although adult and market-sized silver carp are fragile and do not survive collection and transport well, fingerling silver carp are less susceptible to mortality due to handling stress.

Silver carp, caught as bycatch, may be sold as fillets or to live fish markets. Another potential pathway for further introductions is the intentional release of silver carp through animal rights activism or prayer release (the ceremonial release of a fish in honor of the one that will be eaten).

Silver carp have survived, have become established in river systems, and have been reproducing in natural waters of the United States since at least 1995. Because silver carp can occupy lakes, there is serious concern that this species will further expand its range beyond riverine environments and into lake environments including the Great Lakes. If introduced, it is highly likely that silver carp will establish reproducing populations in other major river systems, such as the Potomac/Chesapeake, Columbia, and Sacramento/San Joaquin Delta. In their native range, juveniles and adults are also found in lakes, reservoirs, and canals where they grow well, but probably cannot spawn and recruit without access to an appropriate riverine habitat.

Hybridization of silver carp with native fishes is not known to be possible, but silver carp are known to hybridize and produce viable offspring with both bighead carp ( H. nobilis ), a nonnative species also present in the Mississippi River basin, and largescale silver carp, a species not yet known to be in the United States. Bighead carp × silver carp and the reciprocal cross are fertile. Bighead carp × silver carp are common in parts of the United States. The presence of large numbers of wild-spawned hybrids implies that bighead and silver carp often spawn in the same place at the same time in United States waters. Silver carp × bighead hybrids adversely impact food availability for native species due to the size they attain and the amount of food they eat. Hybrids with largescale silver carp would likely adversely affect food availability for native species as well.

Hybridization may also be possible with grass carp, but hybridization with common carp ( Cyprinus carpio ) is unlikely because the spawning locations and behaviors of the two genera are so different.

Silver carps' food consumption rate is high, but widely variable. Fry at the smallest size class consumed up to 140% of their body weight daily; 63 mg fingerlings consumed just more than 30% and 70-166 mg fingerlings consumed 63% of their body weight. Adult silver carp have been shown to consume 8.8 kilograms (kg) of food per year, with 90% of the consumption occurring during the three warmest months of the year.

Silver carp are quite tolerant of broad water temperatures from 4 °C to 40 °C. Silver carp can grow quickly (20 to 30 kg in 5 to 8 years), and large adults can reach over 1.2 meters in length and 50 kg in weight. Silver carp are difficult to age, but have been reported to live 15-20+ years.

The reproductive potential of silver carp is high and increases with body size. It has been estimated that silver carp weighing 3.18 to 12.1 kg can produce 145,000-5,400,000 eggs. Silver carp mature anywhere from 3-8 years, and males usually mature one year earlier than females. The same female may spawn twice during one growing season. Silver carp exhibit a prolonged spawning period, into late summer or early fall, in the United States.

Due to the large size, fast growth rate, high food consumption rate and high reproductive potential of silver carp, competition for food and habitat with native planktivorous fishes and with post-larvae and early juveniles of most native fishes is likely high. Since nearly all larvae and juvenile fishes are planktivorous and based on other demonstrated impacts, it is highly likely that silver carp are adversely affecting many native fishes in the Mississippi River Basin, particularly in waters where food may become limited, though long-term studies have not yet been conducted. Affected native species include paddlefish ( Polyodon spathula ), bigmouth buffalo ( Ictiobus cyprinellus ), gizzard shad ( Dorosoma cepedianum ), emerald shiner ( Notropis atherinoides ), and threadfin shad ( Dorosoma petenens ). It is highly likely silver carp would adversely affect fishes in the Great Lakes basin or other watersheds, if they establish.

Paddlefish, native to the Mississippi River Basin and Gulf of Mexico river drainages from east Texas to Alabama, is a large river fish that has declined in abundance in recent years because of overharvest and habitat alteration. Like the silver carp, paddlefish uses plankton as its primary food source, so silver carp or hybrids would directly compete with paddlefish for food throughout most of the paddlefish's range. Other fishes, such as buffalos or shads, use both plankton and aquatic invertebrates as food. While these fishes are currently more common than paddlefish, they may be at risk if silver carp, silver × largescale silver carp hybrids, or silver × bighead hybrids establish and reduce plankton. Gizzard shad are a primary forage base for predacious fishes and important to the ecology of Midwestern rivers; thus, the likely competition with silver carp in these waters is cause for concern.

Because silver carp are likely to negatively affect important planktivorous forage fishes such as the gizzard shad and emerald shiner, scientists have indicated that fishes and birds that prey on these species would likely also be negatively affected. Adult silver carp are too large to be preyed on by almost any native predator. Young silver carp have likely been incorporated into the diets of piscivorous birds and fishes to some degree, but the extent of this predation is not known. Ecosystem balance is likely to be modified if silver carp populations become large enough to dominate other planktivorous fish species. The most likely negative effect would be an alteration of fish community structure through competition for food.

Silver carp have been shown to have major effects on nutrient cycling and have had adverse effects on primary productivity, which could alter food webs and ultimately alter nutrient and energy cycling in aquatic communities. There is evidence of nutrient overloading in waters where silver carp have been introduced. Excrement from silver carp has been found to increase levels of certain nutrients, some which cannot be consumed by other animals in the digested form or may be harmful, which has led to a net decrease in food resources available in several studies. Recent studies on the effects of silver carp on toxin-producing blue-green algae indicate that certain species of blue-green algae are often controlled by silver carp, but that other species are often enhanced, particularly those like Microcystis aeruginosa that have a mucosal covering that inhibits digestion by silver carp. These organisms can pass alive through the digestive tract and, in the process, acquire nutrients that can later be used for growth and cell division. Additionally, M. aeruginosa has been shown to produce more toxins in the presence of filter feeding fishes, especially silver carp. Once established, these fish are likely to cause shifts in the food web and compete with other zooplanktivorous fishes and fish larvae for food. Changes in the community structure towards smaller size plankton may have negative effects on fishes native to the United States that subsist on larger zooplankton.

Adverse effects of silver carp on some threatened and endangered freshwater mussels and fishes are likely to be moderate to high. There are currently 116 fishes and 70 mussels on the Federal List of Endangered and Threatened Wildlife. Because silver carp have the same habitat requirements as approximately 40 fishes and 25 mussels currently on the endangered or threatened species list, these listed species will likely be impacted by competition for food and habitat by the introduction and establishment of silver carp.

Habitat requirements, springs and small streams, of the remaining listed fishes and mussels would probably preclude any detectable effects as it is unlikely that silver carp could survive in such small bodies of water.

Adverse effects of established populations of silver carp on endangered and threatened fishes would most likely be through direct competition for food resources, particularly phytoplankton and, to a lesser extent, zooplankton, in the water column during the larval stage. Potential for direct predation and injury of drifting fertilized eggs and larvae of native fishes also exists. The fact that silver carp can become extremely abundant and reach a very large size (> 1 m in length) in rivers, lakes, and reservoirs increases the probability of a negative impact on aquatic ecosystems they invade as high densities of silver carp decrease food availability for native species. Mussels are also filter feeders but live partly or totally buried in the substrate; their association with the benthic environment means that they would be less likely to be affected by filter-feeding silver carp. Nevertheless, changes in the fish community structure caused by silver carp are likely to have adverse effects on abundance and availability of host fishes required for mussel reproduction, which may result in a decline of native mussels.

There is low risk of silver carp causing direct habitat degradation or destruction, although the presence of silver carp is sometimes associated with decreased water clarity, which may also impact benthic chemistry and community structure. The effect of these fishes on nutrients, sediment re-suspension (which can stimulate plankton growth), and decreasing dissolved oxygen varies. Excrement from silver carp, which can equal their body weight in 10 days, has organically enriched lake bottoms and altered the benthic macroinvertebrate community structure.

However, due to the impacts listed above, it is highly likely that silver carp would have adverse effects on designated critical habitats of threatened and endangered species. There are currently 60 species of fishes and 18 mussels with designated critical habitat. Of those, at least 26 inhabit lakes or reaches of streams large enough to support silver carp. Therefore, dense populations of silver carp are likely to affect the critical habitats upon which the threatened and endangered species depend.

Many species of parasites and bacterial diseases occur in silver carp. The only viral disease agent of silver carp found in the literature is Rhabdovirus carpio , the causative agent for spring viraemia of carp (SVC), a systemic, acute, and highly contagious infection that is known to cause mortality in native fishes. Silver carp are susceptible to many diseases caused by parasitic protozoans and trematodes, and several crustacean parasites, such as anchor worm ( Lernaea bhadraensis ), have also been reported from silver carp.

Although there have been studies of disease-causing agents of silver carp, none have investigated the transfer of these pathogens from silver carp to native fishes of the United States. However, two parasites known to infect silver carp are a threat to native North American fishes, including cyprinids: The gill-damaging Lernaea cyprinacea , known as anchorworm (this parasite is also known to affect salmonids and eels), and Bothriocephalus acheilognathi , known as Asian carp tapeworm. The Asian carp tapeworm, initially introduced into U.S. waters from grass carp, has infected native threatened and endangered fishes (including the yaqui chub ( Gila purpurea ), beautiful shiner, ( Cyprinella formosa ), yaqui topminnow ( Poeciliopsis occidentalis sonoriensis ), colorado pikeminnow ( Ptychocheilus lucius ), and humpback chub ( G. cypha )) and fishes of concern such as the roundtail chub ( G. robusta ), a candidate for Federal listing as a threatened or endangered fish and listed as endangered by Colorado, in five States. When infected baitfish were released into Lake Mead, the tapeworm was spread to two endangered fishes, virgin spinedace ( Lepidomeda mollispinis ) and woundfin minnow ( Plagopterus argentissimus ) in Utah and Nevada. Approximately 90% of large juvenile and adult humpback chubs in the Little Colorado River are infected with this cestode. The Asian carp tapeworm has been reported from more than 40 other cyprinid fishes and fishes of other orders. Silver carp are hosts of this parasite, but suffer minimal adverse effects from it. As hosts of this tapeworm, silver carp have the potential to spread it to native fishes, beyond the five States where it has already been found (Arizona, Colorado, Nevada, New Mexico, and Utah). This is a parasite that erodes mucus membranes and intestinal tissues, often leading to death of the host. The most probable pathway of introduction was by the release of infected baitfishes. As the introduced range of silver carp grows in U.S. waters, silver carp will likely spread the parasite and a number of native fishes, particularly, but not limited to, cyprinids, percids, and centrarchids, will likely become hosts of the Asian carp tapeworm.

Some disease-causing agents harbored by silver carp pose health risks to humans. The psychotropic pathogen Listeria monocytogenes has been found in market and fish farm samples of silver carp. Clostridium botulinum was found in 1.1% of fresh and smoked samples of silver carp from the Mazandaran Province in Iran. The toxigenic fungi Aspergillus flavus , Alternaria , Penicillium , and Fusarium were found from silver carp and from pond water in which they were raised at a fish farm in northern Iran. In addition, live Salmonella spp. can be found in silver carp for at least 14 days after transfer to clean water, and silver carp, therefore, should be considered as a potential carrier for Salmonella ( S. typhimumium ).

Silver carp in the United States cause substantial impacts to the health and welfare of human beings who use waterways infested with silver carp. There are numerous reports of injuries to humans and damage to boats and boating equipment because of the jumping habits of silver carp in the vicinity of moving motorized watercraft. Some reported injuries include cuts from fins, black eyes, broken bones, back injuries, and concussions. Silver carp also cause property damage including broken radios, depth finders, fishing equipment, and antennae. Some vessels have been retrofitted with a Plexiglas pilot's cab as protection against jumping silver carp.

If silver carp were introduced or spread into new U.S. waters, it is unlikely that the introduction would be discovered until the numbers were high enough to impact wildlife and wildlife resources. Widespread surveys of waterways are not conducted to establish species' presence lists. Delay in discovery would limit the ability and effectiveness to rapidly respond to the introduction and prevent establishment of new populations. It is unlikely that silver carp could be eradicated from U.S. waterways unless they are found in unconnected waterbodies.

The ability to control spread of established populations depends on their access to open waterways and riverine habitat to spawn. Barriers may help control the spread of silver carp from the Mississippi River basin into the Great Lakes or other waterbodies, but barriers could also negatively affect migratory native fishes. There are still several pathways by which silver carp from established populations in the Mississippi River Basin might be moved to new waterbodies, such as the Potomac River or Columbia River, and become established.

Due to the extensive established range of silver carp in the Mississippi River Basin, conventional control methods are not feasible to reduce established populations. Massive fishing efforts utilizing netting and electrofishing may be effective in reducing populations, but many non-target fish species would also be killed. Justifying the expense of such efforts would require a large commercial demand, which does not currently exist, nor is likely given the jumping behavior of silver carp that makes fishing difficult. Selective removal of silver carp is possible given their location in the water column, but water trawling could also remove other non-target fish such as paddlefish.

The large and growing range of silver carp in U.S. waterways makes chemical control of established populations highly unlikely, both physically and fiscally. Use of chemical treatments, such as rotenone, would be expensive, only locally effective, and would negatively affect all fishes and invertebrates, not just the target carp. At present, there is no method known to substantially reduce established populations of silver carp. Eradication is not possible with presently available technology.

Because the ability to eradicate this species is low, there is little likelihood for rehabilitation or recovery of ecosystems disturbed by this species. Additionally infested waterways allow connections to unpopulated sites. Utilizing sterile silver carp would do little to reduce or remove injuriousness as the present range of establishment in the Mississippi River Basin is too extensive for this option to reduce current silver carp populations in this area. The use of daughterless fish technology (introducing sterile males to produce unviable eggs) may reduce populations, but this would take many years before it would reduce numbers of fish where they currently exist. Research is being conducted on the use of pheromones to control carp, but it is years from demonstrating effectiveness in natural waters and mass production. These technologies might be useful to prevent establishment of silver carp in new areas.

Silver carp are host to many parasites and bacterial diseases that are or could be a threat to native North American fishes. If silver carp transfer pathogens to native fish, the ability and effectiveness to control these transfers would be very low because silver carp and native fishes share the same habitat.

The ability of silver carp to effectively filter particles and reliance on phytoplankton for much of its diet led to research into their effectiveness as a biological control agent for phytoplankton in wastewater systems and other ponds. There is conflicting data concerning the benefit of using silver carp to control excess nutrients. Regardless of their effect on increasing or decreasing phytoplankton and zooplankton abundance, studies have consistently shown that filter feeding by silver carp shifts the species composition of these communities to smaller species. Silver carp have been observed to cause nuisance algal blooms through a trophic cascade. Scientists believe that the removal of larger zooplankton and phytoplankton by foraging silver carp may result in stimulating growth of smaller species.

In summary, the Service finds all forms of live silver carp, including gametes, viable eggs and hybrids, to be injurious to wildlife and wildlife resources of the United States and to the interests of human beings because:

• Silver carp are highly likely to spread from their current established range to new waterbodies in the United States;

• Silver carp are highly likely to compete with native species, including threatened and endangered species, for food and habitat;

• Silver carp have the potential to carry pathogens and transfer them to native fish;

• Silver carp are likely to develop dense populations that will likely affect critical habitat for threatened and endangered species and could further imperil other native fishes and mussels;

• Silver carp are negatively impacting humans;

• It would be difficult to eradicate or reduce large populations of silver carp, or recover ecosystems disturbed by the species; and

• There are no potential ecological benefits for U.S. waters from the introduction of silver carp.

To our knowledge, the largescale silver carp has not been imported into the United States. Within its native range, largescale silver carp occur in subtropical to tropical climates, which exist in parts of the United States. Therefore, should pure largescale silver carp be introduced to U.S. waters, its potential range would likely include subtropical waters such as those present in southern Florida, southern Texas, and Hawaii.

The growth rate of largescale silver carp is greater than that of silver carp. The reproductive capability is expected to be similar to that of silver carp, though largescale silver carp reach sexual maturity at a younger age than silver carp so they will spawn earlier.

In culture situations, silver carp has hybridized with largescale silver carp. The hybrids did not grow as quickly as largescale silver carp but exceeded the growth rate of silver carp. Largescale silver carp × silver carp hybrids were introduced in Kazakhstan where they became established. The climate of Kazakhstan is temperate; thus, largescale silver carp × silver carp hybrids are more cold-tolerant than pure largescale silver carp. The faster growth rate of these hybrids than pure silver carp and the increased palatability of largescale silver carp compared to silver carp may conceivably stimulate interest in culturing either the hybrids or pure largescale silver carp in the United States. Because hybrids can tolerate temperate climates, they have the potential to be cultured in many southern States and would have a wider potential range where they could establish in the United States.

Escape from containment, as has happened with silver carp, would provide a pathway for release of largescale silver carp into natural waters of the United States. Should this fish or its hybrids be released into natural waters, connected waterways would become a secondary pathway for spread. Because of the morphological similarity between this species and silver carp, stock contamination of silver carp by largescale silver carp is possible if imported from regions with populations of H. harmandi . Another possible introduction pathway, should largescale silver carp or their hybrids be imported for culture, would be sale of live individuals in food fish markets.

Likelihood of spread of largescale silver carp, should they be introduced, would be high in subtropical and tropical river systems of the United States. Hybrid largescale silver carp × silver carp, however, would have high potential to live in much of the temperate United States. Because largescale silver carp can occupy and reproduce in reservoirs, they could also live in lakes. The same is likely true for hybrids. Young largescale silver carp or any hybrids captured by anglers for use as live bait would be a pathway that could lead to numerous future introductions of these species.

Hybridization with native fishes is not believed to be possible, but largescale silver carp are known to hybridize and to produce viable offspring with silver carp and possibly bighead carp, both of which are present in U.S. waters. Largescale silver × silver carp hybrids are tolerant of a temperate climate (ca. 42-46° N). (45° N is a latitude that parallels the border between New York State and Ontario, Canada). Therefore, these hybrids would likely be capable of surviving and probably establishing throughout much of the United States where suitable waters exist. Largescale silver carp grow faster than silver carp but hybrids do not grow as quickly as pure largescale silver carp. It is highly likely that any largescale silver carp hybrids would directly compete with native species for food and habitat.

Largescale silver carp consume primarily planktonic food sources. It is unknown if largescale silver carp feed more heavily on phytoplankton than zooplankton, but their hybrids with silver carp would likely show a preference for phytoplankton. Some adults may weigh 20-30 kg. The rapid growth and high fat content of this fish has made it the most cultured species for food in Vietnam. Largescale silver carp and hybrids are highly likely to compete for food with other planktivorous native fishes and with post-larvae and early juveniles of most native fishes should they become established in the United States.

Fishes most likely to be affected are those species whose diet is predominantly plankton including paddlefish ( Polyodon spathula ), native to the Mississippi River Basin and Gulf of Mexico river drainages from east Texas to Alabama, buffalos ( Ictiobus spp.), or shads ( Dorosoma spp.). Given that these fish may already be competing with bighead and silver carps in some areas, the presence of largescale silver carp would increase food competition and increase the likelihood of negative impacts to native species.

Potential for direct predation and injury of drifting fertilized eggs and larvae of fishes exists. Mussels are also filter feeders but live partly or totally buried in the substrate; they would be less likely to be affected by water column filter-feeding largescale silver carp. Nevertheless, changes in the fish community structure caused by largescale silver carp would likely have adverse effects on abundance and availability of host fishes required for mussel reproduction.

There are other possible, but less likely, effects that may cascade through any aquatic ecosystem with an established population of largescale silver carp. Nutrient levels are a concern because there is evidence of overloading of nutrients in waters into which silver carp have been introduced, and the same may apply to largescale silver carp or their hybrids.

Competition for habitat between largescale silver carp and native species is likely high, especially in large rivers, lakes, and reservoirs. Because they are planktivorous, the potential of largescale silver and any hybrids to cause habitat degradation or destruction is low as is direct predation on native mammals, birds, amphibians, reptiles, mollusks or other live, non-aquatic animals.

Additional adverse impacts on native wildlife, wildlife resources, and ecosystem balance are likely few, except for fishes. Ecosystem balance would likely be modified if populations of largescale silver carp or any hybrids become large enough to dominate planktivorous fish species.

Because largescale silver carp may survive and become established and compete with native fishes, there is no acceptable escape or release threshold for largescale silver carp or their hybrids.

Adverse effects of largescale silver carp on selected threatened and endangered freshwater mussels and fishes would be expected to be moderate to high. There are currently 116 fishes and 70 mussels on the Federal List of Endangered and Threatened Wildlife. Because largescale silver carp have the same habitat requirements as approximately 40 fishes and 25 mussels currently on the endangered or threatened species list, these listed species in tropical or subtropical areas will likely be impacted by the introductions of largescale silver carp through competition for food and habitat. However, the habitat requirements, springs and small streams, of the remaining listed fishes and mussels would probably preclude any detectable effects as it is unlikely that largescale silver carp or their hybrids would survive in such small bodies of water.

It is likely that largescale silver carp and highly likely that their hybrids with silver carp would have adverse effects on designated critical habitats of threatened and endangered species. There are currently 60 species of fishes and 18 mussels with designated critical habitat. At least 26 fishes and mussels with critical habitat inhabit lakes or reaches of streams large enough to support hybrids of largescale silver carp and silver carp. Largescale silver carp and their hybrids have the potential to alter food webs and ultimately alter nutrient and energy cycling in aquatic communities. The most likely effect would be an alteration of fish community structure through competition for food. Fishes and mussels that are determined to be candidates for listing under the Endangered Species Act would likewise be at risk.

Native species may be placed in danger of extinction as a result of the introduction or establishment of largescale silver carp if pure stock became established in subtropical or tropical waters in the United States. However, there is a higher risk for negative impacts to native fishes from largescale silver carp hybrids. Large populations of largescale silver carp or hybrids would likely alter native fish community structures, ultimately resulting in decline of native mussels since many rely on native host fishes for reproduction. The fact that largescale silver carp have the potential to become abundant and reach a very large size (> 1 m in length) in rivers, lakes, and reservoirs increases the probability of a negative impact on aquatic ecosystems should largescale silver carp be introduced and become established.

The potential for largescale silver carp to transfer pathogens is largely unknown. No detailed studies of disease-causing agents of largescale silver carp have been found, but at least three trematode parasites ( Dactylogyrus harmandi , D. hypophthalmichthys , D. chenthushenae ) are known to infect largescale silver carp. Bighead, silver, grass, and black carps are known to host the Asian carp tapeworm ( Bothriocephalus acheilognathi ), but it is unknown whether largescale silver × silver carp host this species. Since largescale silver carp are very similar to silver carp, they likely can host the Asian carp tapeworm and infected fish, if introduced to U.S. waters, could spread it to native fishes.

The potential impact on the health and welfare of humans from largescale silver carp or any hybrids is unknown. Because largescale silver carp remain deep in the water column during daylight hours and swim toward the surface at night to feed on plankton, they may be less prone to jumping than silver carp in response to sounds of boat engines during daytime. However, if largescale silver × carp hybrids display the jumping behavior of pure silver carp, their potential to injure humans could be considerable.

If largescale silver carp were introduced into U.S. waters, it is unlikely that the introduction would be discovered until the numbers were high enough to impact wildlife and wildlife resources. Widespread surveys of waterways are not conducted to establish species' presence lists. Delay in discovery would limit the ability and effectiveness to rapidly respond to the introduction and prevent establishment.

If largescale silver carp were to escape and become established in natural waters, management of established populations would be highly unlikely both physically and fiscally. Some control might be possible with massive fishing efforts using nets, but this is unlikely to stem range expansion. There would have to be substantial commercial demand to justify the expense of such efforts.

Chemicals or selective removal may be used to manage populations in localized areas. However, selective removal of largescale silver carp would be difficult because they remain in deeper waters during daylight hours when such removal efforts would probably occur. Pheromones may be a viable option to limit spread; this possibility is under investigation for silver carp, and may have applicability to largescale silver carp.

However, research into this control method is in early stages.

Because no evidence exists that largescale silver carp have been imported or released into U.S. waters, triploidy or induced sterility could potentially reduce injuriousness. However, these processes are costly, time-consuming, and not 100% effective so there is potential for triploid largescale silver carp to cause harm if they were released.

It would be difficult to control the spread of largescale silver carp to new locations except, perhaps, by use of electric, acoustic, physical and other types of barriers. At present, there is no method known to substantially reduce populations of introduced fishes in U.S. waterways. It is highly unlikely that largescale silver carp could be eradicated from U.S. waterways, should they be introduced, unless they are found in unconnected waterbodies.

Although there is no evidence that this species has been introduced or targeted for introduction into the United States, the lack of available methods to detect, eradicate or control introduced populations indicates that should largescale silver carp be introduced, rehabilitation or recovery of ecosystems disturbed by this species would be highly unlikely.

The potential for largescale silver carp or any hybrids to infect native fishes with pathogens is largely unknown. Should such transfers prove viable, the ability and effectiveness to control the spread of pathogens to native fishes would be low.

There are no potential ecological benefits for introduction of largescale silver carp or any hybrids in natural waters of the United States.

In summary, the Service finds all forms of live largescale silver carp, including gametes, viable eggs and hybrids, to be injurious to the wildlife and wildlife resources of the United States and to the interests of human beings because:

• Largescale silver carp are likely to escape or be released into the wild if imported into the United States;

• Largescale silver carp are highly likely to survive, become established, and spread in tropical or subtropical areas of the United States if they escape or are released;

• Largescale silver carp would likely carry pathogens that could be transferred to native fish;

• Largescale silver carp and hybrids are likely to compete with native species, including threatened and endangered species, for food and habitat;

• Largescale silver carp could develop dense populations that would likely affect critical habitat for threatened and endangered species and are highly likely to negatively impact native fishes and mussels;

• Largescale silver carp have been shown to hybridize with silver carp, a nonnative species already established in the United States, and would likely have a larger range than pure largescale silver carp;

• Largescale silver carp hybrids with silver carp may display jumping behavior that could injure humans;

• If largescale silver carp were introduced into the United States, it would be extremely difficult to prevent their spread and to control populations in natural waters;

• It would be difficult to eradicate or reduce large populations of largescale silver carp and to recover ecosystems disturbed by the species; and

• There are no potential ecological benefits from the introduction of largescale silver carp for U.S. waters.

This rule contains potential information collection activity for FWS Form 3-200-42, Import/Acquisition/Transport of Injurious Wildlife. Completion of this form would be necessary to apply for a permit to import, or transport across State lines, any live silver or largescale silver carp, gametes, viable eggs, or hybrids for scientific, medical, educational, or zoological purposes. The Service already has approval from the Office of Management and Budget (OMB) to collect information for this special use permit under OMB control number 1018-0093. This approval expires July 31, 2007. The Service 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.

(a) In accordance with the criteria in Executive Order 12866, OMB has designated this rule as a significant regulatory action.

This rule will not have an annual economic effect of $100 million or more or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government. A brief assessment to clarify the costs and benefits associated with this rule follows.

We expect this rule to have minimal costs. Silver carp are not cultured in the United States, nor do we believe that they are imported or exported. Currently, there are some commercial fisheries for silver carp in the Mississippi, Missouri, and Illinois rivers. Usually, commercial fishermen are catching silver carp as bycatch, which can account for up to 50 percent of the catch. Silver carp are not favorable because of their jumping habits and because they are less desirable by the consumer. In Missouri, many of the fishermen do not primarily target Asian carp (bighead and silver carp) because the price received is low ($0.10-$0.15 per pound). Instead, they fish for bighead and silver carp when other species or opportunities are unavailable. Many fishermen do not distinguish between bighead carp and silver carp.

Data for the silver carp fishery are limited. According to public comments received, small commercial fisheries for silver carp exist in Illinois, Iowa, and Kentucky. Table 1 shows commercial fishery landings and value in Iowa and Illinois in 2003. Compared to the total commercial harvest and value, Asian carp represented 11 percent of landings and 6 percent of value in 2003. Because Illinois does not distinguish between bighead carp and silver carp in its annual report, we are unable to determine the magnitude of silver carp landings for the entire area. For Iowa, silver carp represented less than 1 percent of total landings. In 2005, silver carp represented less than 1 percent of commercial landings in Kentucky and less than one-tenth of commercial landings in Louisiana (public comments, J. Gassett 25 Oct 2006 and J. Roussel 6 Nov 2006).

The majority of the silver carp catch is sold as round weight. In Illinois, fishermen can sell silver carp as long as they are not transported live once the fish are taken off the water. No impacts are expected to the silver carp market because they are not delivered live.

The market for live silver carp in U.S. markets is unknown and no public comments received reported a U.S. market for live silver carp. It is possible that silver carp are inadvertently shipped along with live bighead carp. However, most live haulers will not haul live silver carp because the fish do not transport well. Furthermore, the consumer prefers bighead carp to silver carp. Because only sales of live silver carp would be regulated by this rulemaking, we do not expect any impacts to commercial fishermen unless they are transporting live silver carp across State lines for processing. While the exact impact is unknown, we expect it to be minimal.

There is no known use for largescale silver carp in the United States or import or export of the species into or from the United States. We do not know of any future plans to use largescale silver carp in the United States. During the public comment period, no comments reported largescale silver carp being used. Therefore, we do not expect the rule to add largescale silver carp to the list of injurious wildlife to have any costs.

Within several waters of the Midwest, silver carp comprise a percentage of the commercial catch as bycatch (non-target species). This may be negatively impacting revenue for commercial fishermen because silver carp are not as valuable as the native species that are targeted.

Furthermore, it is possible that silver carp populations will be delayed or not become established in new watersheds (Columbia Basin, Chesapeake Basin, and Sacramento-San Joaquin Delta) with similar attributes as the Mississippi River Basin as a result of this rulemaking. Silver carp are likely to compete with native fish for food, causing declines in native fishes in the United States, particularly those that rely heavily on plankton as a food resource.

Thus, this rule will protect native fish, and the recreational and commercial fisheries associated with native fish. In terms of recreational fisheries, benefits would accrue due to (1) consumer surplus generated from fishing native fish and (2) fishing-related expenditures such as food, lodging, and equipment. In terms of commercial fisheries, benefits would accrue due to the revenue from fishing native fish, which are more valuable than silver carp. The timeline for when these benefits would accrue depends on the potential spread and impacts of silver carp. The extent of benefits to recreational and commercial fisheries is unknown.

There have been no reports that largescale silver carp are in the United States. However, native fish populations are likely to decline if largescale silver carp were to establish populations in the United States. With this rule, we reduce the risk of the introduction and establishment of largescale silver carp (or any hybrids) in U.S. watersheds. Thus, this rule protects native fish and the recreational and commercial fisheries associated with native fish. In terms of recreational fisheries, benefits would accrue due to the continued (1) consumer surplus generated from fishing native fish and (2) fishing-related expenditures such as food, lodging, and equipment. In terms of commercial fisheries, benefits would accrue due to the continued revenue from fishing native fish. The extent of benefits to recreational and commercial fisheries is unknown because it depends on the introduction and subsequent establishment of largescale silver carp populations in the United States.

(b) This rule will not create inconsistencies with other Federal agencies' actions. This rule pertains only to regulations promulgated by the Service under the Lacey Act. No other agencies are involved in these regulations.

(c) This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. This rule does not affect entitlement programs. This rule is aimed at regulating the importation and movement of nonindigenous species that cause or have the potential to cause significant economic and other impacts on natural resources that are the trust responsibility of the Federal Government.

(d) OMB has determined that this rule raises novel legal or policy issues.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever a Federal agency publishes a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions) (5 U.S.C. 601 et seq.). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule would not have a significant economic impact on a substantial number of small entities. Thus, for a regulatory flexibility analysis to be required, impacts must exceed a threshold for “significant impact” and a threshold for a “substantial number of small entities.” See 5 U.S.C. 605(b). SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule would not have a significant economic impact on a substantial number of small entities.

This rulemaking may impact a small number of fishermen selling live silver carp. The number of fishermen targeting silver carp is unknown. Because the market for live silver carp is also unknown, we are unable to estimate the degree of impact of this rulemaking. We expect this rulemaking to have a minimal effect on commercial fishermen selling live silver carp because many live haulers do not transport live silver carp. We do not expect this rulemaking to affect aquaculture because silver carp, largescale silver carp, or any hybrids are not being cultured in the United States at this time.

Many small businesses within the retail trade industry (such as hotels, gas stations, taxidermy shops, bait and tackle shops, etc.) may benefit from continued recreational fishing without impacts from silver carp, largescale silver carp, or any hybrids. Furthermore, small businesses associated with commercial fishing (fishermen, wholesalers, and retailers) will also benefit from continued commercial fishing without impacts from silver carp, largescale silver carp, or any hybrids. We do not know the extent to which these small businesses will continue to benefit. However, we expect this benefit to be distributed across various watersheds, and so we do not expect that the rule will have a significant economic effect (benefit) on a substantial number of small entities in any region or nationally.

Therefore, we certify that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). An initial or final Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. For the reason described below, no individual small industry within the United States will be significantly affected if silver carp or largescale silver carp importation is prohibited.

The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

(a) Does not have an annual effect on the economy of $100 million or more. Silver carp is in limited commercial trade in the United States and primarily as fillets; the largescale silver carp is not known to be imported or present in the United States. Silver carp are likely to negatively affect many native fishery resources if they continue to spread in the United States. The largescale silver carp could devastate many native fishery resources if it is introduced to U.S. waterways. This rulemaking will protect the environment from the introduction and spread of nonnative species and will indirectly work to sustain the economic benefits enjoyed by numerous small establishments connected with recreational and commercial fishing.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), this rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule would not prohibit intrastate transport or any use of silver carp or largescale silver carp within State boundaries. Any regulations concerning the use of silver carp or largescale silver carp within individual States will be the responsibility of each State. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act is not required.

In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implication assessment is not required. This rule would not impose significant requirements or limitations on private property use.

In accordance with Executive Order 13132, the rule does not have significant Federalism effects. A Federalism assessment is not required. This rule would not have substantial direct effects on States, in the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, we determine that this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order. The rule has been reviewed to eliminate drafting errors and ambiguity, was written to minimize litigation, provides a clear legal standard for affected conduct rather than a general standard, and promotes simplification and burden reduction.

We have prepared environmental assessments (EAs) in conjunction with this rulemaking, and have determined that this rulemaking is not a major Federal action significantly affecting the quality of the human environment within the meaning of section 102(2)(C) of the National Environmental Policy Act (NEPA of 1969 (42 U.S.C. 4321 et seq.)). No comments on the draft environmental assessments were received. For copies of the final EAs, contact the individual identified above in the section FOR FURTHER INFORMATION CONTACT , or access the documents at http://www.fws.gov/contaminants/ANS/ANSInjurious.cfm.

Adding silver carp and largescale silver carp to the list of injurious wildlife is intended to prevent their further introduction and establishment into natural waters of the United States in order to protect native fishes, the survival and welfare of wildlife and wildlife resources, and the health and welfare of humans. Not listing silver carp as injurious may allow for an expansion to States where they are not already found, thus increasing the risk of their escape and establishment in new areas due to accidental release and, perhaps, intentional release. Their establishment is negatively impacting native fish, wildlife, and humans. Silver carp are established throughout much of the Mississippi River Basin. Releases of silver carp into natural waters of the United States are likely to occur again, and the species is likely to become established in additional U.S. waterways, threatening native fish populations, wildlife, and wildlife resources dependent on phytoplankton, zooplankton, bacteria, and detritus, and impacting human health.

Largescale silver carp are not known to be in the United States, but if introduced to natural waters, they would likely impact the welfare and survival of native fish and wildlife, as well as the health and welfare of humans. In addition, largescale silver carp are visually similar to silver carp and can readily hybridize with silver carp, so they would be difficult to distinguish from silver carp.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated potential effects on Federally recognized Indian tribes and have determined that there are no potential effects. This rule involves the importation and interstate movement of all forms of live silver carp, largescale silver carp, gametes, viable eggs, and hybrids. We are unaware of trade in these species by Tribes.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to affect energy supplies, distribution, and use. Therefore, this action is a not a significant energy action, and no Statement of Energy Effects is required.

A complete list of all references used in this rulemaking is available upon request from the Branch of Invasive Species (see the FOR FURTHER INFORMATION CONTACT section).