Airspace Docket No. 10-AWP-20, published in theFederal Registeron March 10, 2011, (76 FR 13082), amends VOR Federal Airways V-1, V-7 V-11 and V-20; Kona, HI. These VHF Omnidirectional Range Federal airways are being impacted by flight inspection delays due to the relocation of the VHF Omnidirectional Radio Range and Tactical Air Navigation Aid (VORTAC) thereby delaying the effective date of May 5, 2011, to August 25, 2011.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation (1) is not a significant regulatory action under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

As of 12:01 a.m. on April 9, 2011, the continuing resolution that funds many Federal government activities is set to expire. Unless additional appropriations are enacted, Federal departments and agencies whose continued operations are dependent upon such funding—including the Commodity Futures Trading Commission (the “Commission”)—will be required to execute contingency plans for this lapse in appropriations (commonly referred to as a “shutdown”). Under 31 U.S.C. 1341 (the “Anti-Deficiency Act”), the Commission is prohibited from expending or obligating any funds in the absence of appropriations, subject to a narrow set of exceptions.1 One exception that applies to the Commission is “emergencies involving the safety of human life or theprotection of property.”2 It has been recognized that certain commodity market functions may continue during a lapse in appropriations.3 Thus, the Commission has designated certain essential personnel to fulfill its obligation to protect property.

The Commission's regulations place a number of filing obligations on registered entities, intermediaries, market participants and the public within specified time frames and also include provisions relating to requests for Commission approval and issuance of exemption and interpretative relief and guidance with specific time frames for Commission action. The Commission has reviewed its rules in light of its obligation to protect property to determine which obligations will continue to apply during a lapse in appropriation.

In the event of a lapse in appropriations, the Commission will not be officially receiving, processing, or reviewing filings for Commission approval or action that are not directly related to the protection of property. Matters not directly related to the protection of property include rule, rule amendment, and contract certifications, except for emergency rules certified pursuant to regulation 40.6(a)(2); rules, rule amendments and contracts voluntarily submitted for Commission approval; requests for contract market designation and derivatives clearing organization and derivatives trade execution facilities registration; and other requests for Commission approval or relief. The above-mentioned matters do not include any emergency notifications that may be required by Commission regulations of registered entities and intermediaries, or that are required by any rule of a registered entity that has been approved by or self-certified to the Commission.

More specifically, matters not directly related to the protection of property include filings under regulation 1.47 and regulation 1.48 (bona fide hedge requests), part 36 (notification filings and information on trading), part 37 (derivatives trading execution facility applications, certifications of continued compliance in situations of merger or sale, and demonstrations of compliance with the core principles), part 38 (designated contract market applications, certifications of continued compliance in situations of merger or sale, and demonstrations of compliance with the core principles), part 39 (derivatives clearing organization applications, requests for orders regarding competition, and demonstrations of compliance with the core principles), part 40 (rule and contract filings (both certifications and approvals and requests for confidential treatment of submissions)), part 41 (filing of notice-designated contract markets trading security futures products), regulations 145.7 and 145.9 requests (requests for Commission records, petitions for confidential treatment of information submitted to the Commission, and appeals of FOIA decisions), regulation 140.99 filings (requests for exemptive, no-action and interpretive letters), and petitions for grandfather relief under section 734 of the Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) pursuant to the Commission's order that became effective on September 10, 2010.4 For matters that are currently pending before the Commission pursuant to any of these provisions, all applicable time deadlines for Commission action will be tolled until the Commission is able to resume full operations.

Matters not directly related to the protection of property also include certain procedural rules associated with Commission adjudicatory actions, in particular certain rules under part 3 (procedure to deny, condition, or suspend, revoke, or place restrictions on registration), part 9 (related to review of exchange disciplinary, access denial or other adverse actions), part 10 (the Commission's rules of practice for adjudicatory proceedings before the Commission), part 12 (rules related to reparations proceedings), and part 171 (review of National Futures Association decisions). For these matters that are currently pending before the Commission pursuant to any of these provisions, all applicable time deadlines for Commission action will be tolled until the Commission is able to resume full operations. Moreover, all applicable time deadlines for parties to an adjudicative proceeding that arise during a lapse in appropriations will be extended until one business day after the Commission resumes its full operations.

The Commission's regulations also impose filing obligations on registered entities, intermediaries, market participants and the public. The Commission has determined that certain filing requirements will remain in effect in order for the Commission to fulfill its obligation to protect property even during a lapse of appropriations. Accordingly, such filing requirements will continue to be in effect during the lapse in appropriations and such filings will continue to be received and processed. This category includes regulation 1.10 filings (financial reports of futures commission merchants (FCMs) and introducing brokers (IBs)), regulation 1.12 filings (notice provisions required of FCMs and IBs), regulation 1.17 filings (capital requirements (business days would include those days the Commission is shutdown for purposes of requirements relating to margin calls and the computation of margin) and any notice provision requirements)),5 regulation 1.32 filings (segregation calculation (business days would include those days the Commission is shutdown for purposes of requirements related to segregation)), regulation 1.65 filings (notice of bulk transfers (a business day would include those days the Commission is shutdown)), and regulation 30.7 filings (formal secured amount requirements (a business day would include those days the Commission is shutdown)). For these regulations, the business day requirements will not be affected by a lapse in appropriations. Also in this category are part 15 filings (general reporting requirements), part 16 filings (clearing member reports), part 17 filings (FCM reports), part 18 filings (reports by traders), part 19 filings (bona fide hedge position reports), part 21 filings (special call provisions), and regulation 40.6 filings (emergency rules of a registered entity).

The Commission's regulations require and industry practice provides for notification to the Commission and its staff of certain emergency situations. Thus registered entities andintermediaries should continue to provide the Commission notice of emergency situations such as system malfunctions, cyber security incidents or financial emergencies throughout a lapse in appropriations.

Finally, the Commission has proposed a number of rules to implement the Dodd-Frank Act for which the comment period may expire while the Commission is shutdown. The Commission will be unable to officially receive and process comment submissions until it resumes full operations. Therefore, the Commission is extending the comment periods for such rules, and for any other matters that may be subject to a request for comment by the Commission, until one business day after the Commission is able to resume full operations. Notice of the lifting of a shutdown will be provided on the Commission's Web site.

To the extent that some of the provisions of this order may be subject to notice and comment under the Administrative Procedure Act (“APA”),6 and may be subject to the provisions of the APA that require publication or service of a substantive rule be made not less than 30 days before its effective date,7 the Commission for good cause finds that notice and comment and a delayed effective date are impracticable and contrary to the public interest. The Commission may be obligated to commence orderly shutdown of its operations at the commencement of business on April 11 and has determined that it is in the interest of the public and the markets it regulates to have established and publicized its procedures for limiting its operations to only those that are essential to the protection of property before that time.

Moreover, though the tolling of certain procedural time limits will delay the Commission's review and approval of certain industry filings, the review and approval provisions in the Commission's regulations implement review and approval provisions of the Commodity Exchange Act (“CEA”) in order to protect the public interest. It would be contrary to the CEA, and to the public interest, if these review and approval time limits continued to run while the Commission is unable to conduct routine business.

Finally, in order to protect the property interests of the public related to the orderly operation of the futures markets, the Commissioners will be supported by essential personnel in the surveillance of the markets in order to identify any emergency market situations that may require action to protect property during a lapse in appropriations. It therefore is essential that reporting regulations associated with market surveillance and emergency notices continue to operate.

The Paperwork Reduction Act provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it has been approved by the Office of Management and Budget (“OMB”) and displays a currently valid control number.8 The collections of information referenced in this notice and order have valid control numbers that are currently in effect. Therefore, the Commission is not obligated to seek a control number in connection with this order.

The Regulatory Flexibility Act (“RFA”) requires the Commission to consider whether a rule it proposes will have a significant economic impact on a substantial number of small entities and either provide a regulatory flexibility analysis respecting the significant impact or certify that the rule will not have such an impact.9 The RFA is applicable only to a rule for which the Commission publishes a general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b).10

The Commission is not publishing this order as a general notice of proposed rulemaking. Therefore, neither a regulatory flexibility analysis nor a certification is required for this rulemaking action. Nonetheless, this order will impose no new regulatory obligations on any party. Rather, it simply establishes the limited regulatory framework under which the Commission will operate during a shutdown in order to ensure the protection of property. Accordingly, as permitted by 5 U.S.C. 605, the Chairman, on behalf of the Commission, hereby certifies that the provisions contained in this order will not have a significant economic impact on a substantial number of small entities.

Section 15(a) of the CEA11 requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA. Section 15(a) specifies that the costs and benefits shall be considered against five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations. The Commission may give greater weight to one or more of the five enumerated considerations to determine, in its discretion, that a particular rule is necessary or appropriate to protect the public interest or to effectuate any of the provisions or accomplish any of the purposes of the CEA.

This order imposes the cost of delay on parties with petitions for approval, self-certification filings, rights of review, and adjudicative matters before the Commission. As the Commission is limited by law to function most notably with respect to the protection of property, these costs are unavoidable.

In terms of benefits, this order provides for the limited continuation of Commission business. The order also confirms the ongoing regulatory obligations of registered entities and intermediaries notwithstanding a shutdown, in order to ensure that the Commission has available to it all information necessary to identify emergency situations and take action to protect property and, hence, to protect market participants and the public, the efficiency and financial integrity of the futures markets, and price discovery.

The order also notifies market participants and the public of the matters in which the Commission will be engaged, as well as of the tolling and extensions of time put in place with respect to filings under Commission regulations. Tolling ensures that the Commission will have an opportunity to review routine industry filings and take steps if necessary to protect the interests of the market and the public before those filings are finalized. The extensions of time ensure that all persons with filing obligations in certain adjudicative proceedings that arise during a shutdown or who wish to submit comments during a comment period that will close during a shutdown will not be prejudiced by the inability of the Commission to accept those filings or comments.

In light of the foregoing, the Commodity Futures Trading Commission (the “Commission”) has determined to issue the following Order, pursuant to its authority under the provisions of the Commodity Exchange Act, 7 U.S.C. 1et seq.,and in compliance with the Anti-Deficiency Act, 31 U.S.C. 1341 and 1342.

It is hereby orderedthat, in the event of a lapse in appropriations (also referred to as “shutdown”) commencing at 12:01 a.m. on April 9, 2011, the Commission will commence operating according to the procedures set forth in this Order:

1. Tolling and Extension of Certain Procedural Time Limits.The Commission will not officially receive or process any filings, or review any matters for Commission approval or action to the extent that the matters are not directly related to the protection of property or market surveillance. This applies to rule, rule amendment and contract certifications, except for emergency rules certified pursuant to regulation 40.6(a)(2); rules, rule amendments and contracts voluntarily submitted for Commission approval or review; requests for contract market designation and derivatives clearing organization and derivatives trade execution facilities registration; and other requests for Commission approval or other action. Specifically, the time limits for Commission action shall be tolled for §§ 1.47 and 1.48 of the Commission's regulations, and parts 36, 37, 38, 39, 40 and 41. Tolling also applies to requests and appeals submitted under §§ 145.7 and 145.9 of the Commission's regulations, and requests submitted under § 140.99.

The time for officially receiving, processing, or reviewing any new matters under these provisions of the Commission's regulations shall be tolled until the Commission is able to resume full operations. For matters that are pending under these provisions when a lapse in appropriations occurs, all applicable time deadlines for Commission action will be tolled until the Commission is able to resume full operations.

This tolling and extension of time limits also shall apply to certain procedural rules associated with Commission adjudicatory actions, in particular the time-limited procedural rules under parts 3, 9, 10, 12, and 171. For matters that are currently pending before the Commission under any of these parts, all applicable time deadlines for Commission action will be tolled until the shutdown is no longer in effect. Moreover, all time deadlines for filings by a party in an adjudicative proceeding that arise during a shutdown period will be extended until one business day after the Commission resumes its full operations. The filing of replies to any filing delayed by a lapse in appropriations will have its reply period extended for the same number of days.

2. Procedures and Time Limits Not Extended or Tolled.The Commission will continue to receive and process filings required of a registered entity or intermediary under certain Commission regulations, specifically under §§ 1.10, 1.12, 1.17, 1.32, 1.65, 30.7, and 40.6(a)(2), or any emergency notification to the Commission that may be required by any rule of a registered entity that has been approved by or self-certified to the Commission. Paragraph 1 also shall not apply to filings under parts 15, 16, 17, 18, 19, and 21 of the Commission's regulations.

3. Extension of Open Comment Periods on Proposed Regulation and Other Matters that may be Subject to a Request for Comment by the Commission.Any comment period for a proposed rulemaking or other matter that may be subject to a request for comment by the Commission that terminates during the shutdown shall be extended until one business day after the Commission resumes its full operations after a shutdown.

1. On October 16, 2008, the Commission issued Order No. 717 amending the Standards of Conduct for Transmission Providers (the Standards of Conduct or the Standards) to make them clearer and to refocus the rules on the areas where there is the greatest potential for abuse.1 On October 15, 2009, the Commission issued Order No. 717-A to address requests for rehearing and clarification of Order No. 717, largely affirming the reforms adopted in Order No. 717.2 On November 16, 2009, the Commission issued Order No. 717-B to address expedited requests for rehearing and clarification concerning paragraph 80 of Order No. 717-A and whether an employee who is not making business decisions about contract non-price terms and conditions is considered a “marketing function employee”.3 On April 16, 2010 theCommission issued Order No. 717-C to provide additional clarification concerning matters petitioners raised regarding the Commission's determinations in Order No. 717-A.4 In this order, the Commission addresses an additional request for rehearing and clarification concerning Order No. 717-C.

2. In paragraph 16 of Order No. 717-C, the Commission clarified that “a system impact study performed pursuant to a request for energy resource interconnection service or network resource interconnection service is similar to long-range planning and therefore not a transmission function, because the focus of such a study is to determine the impact of the proposed interconnection on the safety and reliability of the transmission provider's transmission system, but without conveying a right to transmission service”.5 As a result, the Commission concluded that the performance of a system impact study in the context of evaluating an energy resource interconnection service and network resource interconnection service is not a transmission function.

3. The Transmission Access Policy Study Group (TAPS) requests rehearing and clarification of one aspect of Order No. 717-C. Specifically, TAPS requests that the Commission grant rehearing to hold that employees who perform system impact studies (or other studies) in connection with interconnection service requests are transmission function employees. TAPS argues that the consequence of a finding that “performance of a system impact study in the context of evaluating an energy resource interconnection service and network resource interconnection service is not a transmission function” is that the studies may be performed by the Transmission Provider's “merchant-function” personnel.

4. TAPS further argues that the Commission created an inconsistency with its regulatory text when it clarified in Order No. 717-C that the performance of a system impact study in the context of evaluating an energy resource interconnection service and network resource interconnection service is not a transmission function. Specifically, TAPS cites 18 CFR 358.3(h), which defines “transmission functions” as “the planning, directing, organizing or carrying out of day-to-day transmission operations, including the granting and denying of transmission service requests.” TAPS then argues that because 18 CFR 358.3(f) defines “transmission” as “the interconnection with jurisdictional transmission facilities,” employees who perform studies that identify upgrades needed for interconnection, or who otherwise help to determine the terms on which interconnection may occur, perform a transmission function.

5. Alternatively, TAPS requests that the Commission clarify that system study information be treated like other planning information, which the Commission requires transmission providers to make available on a non-discriminatory basis to all interested transmission customers. TAPS is concerned that if “merchant-function” personnel are permitted to conduct interconnection-related studies and have access to customer information, “merchant-function” personnel would obtain undue competitive advantages over any other transmission customer.

6. TAPS further requests clarification of paragraph 17 of Order No. 717-C to make clear that where an employee performs system impact studies in response to transmission service requests, the employee's designation as a transmission-function employee does not turn on the duration of the requested transmission service.

7. We deny TAPS' request that we classify employees who perform system impact studies in connection with interconnection service requests as transmission function employees.6 Whether an employee performing a system impact study is a transmission function employee depends upon the purpose for which that study is being performed. The key factor in determining whether the employee is performing a transmission function in conducting the system impact study is whether the performance of that study implicates the day-to-day operation of the transmission system. Thus, an employee performing system impact studies that do not implicate the day-to-day operations of the transmission system would not be a transmission function7 employee, even in those instances where the system impact study pertains to interconnection.

8. In Order No. 717-C, we found that a system impact study performed pursuant to a request for energy resource interconnection service or network resource interconnection service is similar to long-range planning and therefore not a transmission function because it does not involve the conveyance of a right to transmission service. Contrary to the argument raised by TAPS, our focus in reaching this determination was not based on a distinction between transmission and interconnection. Our conclusion was based upon our finding that these types of system impact studies are analogous to transmission long range planning studies, and that neither type of study implicates day-to-day transmission operations.8 The performance of a system impact study is not a transmission function so long as the performance of this system impact study is not carried out as part of day-to-day transmission operations, including the granting or denying of transmission service.9

9. TAPS is also incorrect that the Commission's clarification in Order No. 717-C concerning the performance of system impact studies created an inconsistency with its regulatory text. The definition of “transmission functions” includes “the planning, directing, organizing or carrying out of day-to-day transmission operations, including the granting and denying of transmission service requests.”10 “Transmission” is defined to include “the interconnection with jurisdictional transmission facilities.”11 Thus, the definition of transmission functions includes the planning, directing, organizing or carrying out of day-to-day interconnection operations with jurisdictional transmission facilities. Because of the limiting phrase “day-to-day transmission operations,” TAPS is incorrect in its conclusion that “transmission functions” always includeinterconnection-related system impact studies.

10. Similarly, we deny TAPS's request that the information from system impact studies be made available on a non-discriminatory basis to all interested transmission customers. TAPS erroneously assumes that the Commission determined that system impact studies (or other studies) performed in response to interconnection requests are planning activities that may be conducted by marketing function employees. Marketing function employees may not perform system impact studies (or other studies) in response to interconnection requests since the studies would involve the use and analysis of non-public transmission information. As we stated in Order No. 717, planning personnel who do not qualify as marketing function employees may discuss information with transmission function employees.12 However, we reiterated that the No Conduit Rule applied in this situation, stating that if transmission employees share transmission function information with planning personnel, the planning personnel may not pass such information on to marketing function employees. The clear implication of these statements is that while planning studies may be conducted by personnel who are not transmission function employees, marketing function employees may not participate in the preparation of studies which involve the use and analysis of non-public transmission information.13

11. We grant TAPS's clarification request that when an employee performs a system impact study in response to a transmission service request, that employee is a transmission function employee regardless of the duration of the requested transmission service. This clarification is consistent with our previous conclusion that the designation of an employee as a transmission function employee does not depend upon the duration of the requested transmission service.14

12. In addition to publishing the full text of this document in theFederal Register, the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.

13. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.

14. User assistance is available for eLibrary and the FERC's website during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or e-mail atferconlinesupport@ferc.gov,or the Public Reference Room at (202) 502-8371, TTY (202) 502-8659. E-mail the Public Reference Room atpublic.referenceroom@ferc.gov.

15. Changes to Order No. 717-C adopted in this order on rehearing and clarification are effective May 16, 2011.

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.

Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the FD&C Act. FDA will, within 60 days of receiving this request, classify the device by written order. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in theFederal Registerannouncing this classification.

In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order onDecember 22, 2008, classifying the Erchonia Low Level Laser System for Aesthetic Use into class III because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On January 5, 2009, Erchonia, Inc., submitted a petition requesting classification of the Erchonia Low Level Laser System for Aesthetic Use under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II. (Ref. 1)

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.

The device is assigned the generic name Low Level Laser System for Aesthetic Use, and it is identified as a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.

FDA has identified the following risks to health associated specifically with this type of device and the recommended measures to mitigate these risks.

• Ocular injury is a recognized hazard from laser optical systems because of the unique physical characteristics of laser light; that is, this optical radiation is easily transmitted into the eye as a very bright, intense light beam that may produce lesions on the retina. This hazard is addressed by device labeling, which includes recommendations for not looking directly at the laser beam and the wearing of appropriate laser safety eyewear by both the user and patient. The labeling also includes information defining the size of the area within which this optical hazard exists.

• Electrical shock is addressed by recommended testing of the device according to recognized U.S. and international standards specifically designed to determine and measure potential electrical safety. Again, the recommended device labeling also includes specific warnings for the user in terms of device placement, appropriate electrical wiring needs, reminders to periodically check device wiring and accessories for damage, and avoidance of use of the device in environments where electrical shock is possible.

• Unintended cell damage is a potential risk from use of low level lasers if improper or incorrect energy is used to initiate the process of causing lipid and fat leakage from the target adipocyte cells. The intended effect on the adipocyte cells is the creation of pores that results in the lipid or fat leaving these specialized cells; however, if the laser parameters are not correct, no effect may occur in terms of adipocyte change or other non-adipocyte cells may be affected, resulting in alteration of other cellular membranes or transport systems that could result in unintended cell death.

• Use error represents those risks to the patient that can occur from improper use of the device. In order to address this potential risk, we recommend the manufacturer provide a detailed operator manual, which contains information on possible risks and hazards and how these should be avoided and clear recommended safe treatment procedures that include information on device settings for treatment, clear information on how the device is to be used during treatment, and recommended posttreatment care.

FDA believes that the class II special controls guidance document will aid in mitigating the potential risks to health as described in table 1 of this document.

FDA believes that the special controls guidance, “Low Level Laser System for Aesthetic Use,” in addition to general controls, address the risks to health and provide reasonable assurance of the safety and effectiveness of the device. Therefore, on August 24, 2010, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying the classification of the device by adding § 878.5400.

Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for low level laser system for aesthetic use will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurance of safety and effectiveness.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of thesafety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the low level laser system for aesthetic use they intend to market.

The Agency has determined under 21 CFR 25.34(b) 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.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this final rule is not a significant regulatory action as defined by the Executive order and so it is not subject to review under the Executive order.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of this device from class III to class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. (See section 521 of the FD&C Act (21 U.S.C. 360k); SeeMedtronic, Inc.,v.Lohr,518 U.S. 470 (1996); andRiegelv.Medtronic, Inc.,128 S. Ct. 999 (2008)). The special controls established by this final rule creates “requirements” for specific medical devices under 21 U.S.C. 360k, even though product sponsors have some flexibility in how they meet those requirements. (SeePapikev.Tambrands, Inc.,107 F.3d 737, 740-42 (9th Cir. 1997)).

FDA concludes that this final rule contains no new collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not required. This final rule establishes as special controls a guidance document that refers to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by OMB under the PRA. Elsewhere in this issue of theFederal Register, FDA is issuing a notice announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use” that will serve as the special control for this device. This notice contains an analysis of the paperwork burden for the guidance document.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Petition from Erchonia, Inc., January 5, 2009.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, Sacramento River, at Sacramento, CA. The Tower Drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open on signal if at least four hours notice is given, as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 8 a.m. to 9 a.m. on April 17, 2011 to allow the community to participate in the Change of Pace Foundation's Capitol City Classic Foot Race. This temporary deviation has been coordinated with waterway users. There are no scheduled river boat cruises or anticipated levee maintenance during this deviation period. No objections to the proposed temporary deviation were raised.

Vessels that can transit the bridge, while in the closed-to-navigation position, may continue to do so at any time.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Regulatory Information

On November 3, 2010, we published a notice of proposed rulemaking (NPRM) entitled Security Zone; Increase of Security Zones under 33 CFR 165.1183 from 100 to 500 yards; San Francisco Bay, Delta Ports, Monterey Bay, and Humboldt Bay, CA in theFederal Register(75FR212). We received 5 comments on the proposed rule. No public meeting was requested, and none was held.

Experiences during security zone enforcement operations, observations during boat tactics training, and discussions with Commanding Officers/Officers in Charge and tactical coxswains from Sector San Francisco's Level I Ports, Waterways & Coastal Security (PWCS) stations, has led Enforcement staff and field units to determine that 100-yard (91 meters) security zones are not adequate enough to protect transiting vessels from sabotage, subversive acts, accidents, criminal actions, or other causes of a similar nature. A 500 yard (457 meters)security zone increases reaction time, allows proper assessment of the situation, and improves the ability of the tactical coxswains to properly execute protective measures.

The Coast Guard received general comments on the NPRM concerned that the increased size of the security zone would increase hazards to navigation since 500 yards limits access to large portions of the San Francisco Bay. This included anchorages, leading to an increase of recreational boaters transiting through the main shipping channels. In addition, recreational boaters questioned how the security zone would be enforced when patrol boats were no longer on scene with the vessel. From this input, the Coast Guard is revising the final rule so that the Coast Guard will enforce a permanent increase in security zone size from 100 yards (91 meters) to 500 yards (457 meters) for tankers, cruise ships, and High Value Assets (HVAs) while underway on the navigable waters of San Francisco Bay, Delta Ports, Monterey Bay, and Humboldt Bay, CA. Once a tanker, cruise ship, or HVA is anchored or moored within the navigable waters of San Francisco Bay, Delta Ports, Monterey Bay, and Humboldt Bay, CA, the security zone will decrease from 500 yards (457 meters) to 100 yards (91 meters). The definition for High Interest Vessel (HIV) is being removed and will be replaced with the term HVA because it covers a broader range of vessels that require security zones.

Security zones will be enforced by Coast Guard patrol craft and other law enforcement agencies as authorized by the Captain of the Port. See 33 CFR 6.04-11, Assistance of other agencies.

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

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

The effect of this regulation will not be significant because the 500 yard (457 meters) increase will be activated while High Value Assets (HVAs) are underway on the navigable waters of San Francisco Bay, Delta Ports, Monterey Bay, and Humboldt Bay, CA. Once the HVA is anchored or moored within the navigable waters of San Francisco Bay, Delta Ports, Monterey Bay, and Humboldt Bay, CA, the security zone will decrease from 500 yards (457 meters) to 100 yards (91 meters).

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. We expect this rule may affect owners and operators of vessels, some of which may be small entities, intending to fish, sightsee, transit, or anchor in the waters affected by these security zones. These security zones will not have a significant economic impact on a substantial number of small entities for several reasons: Small vessel traffic will be able to pass safely around the area and vessels engaged in event activities, sightseeing and commercial fishing have ample space outside of the area governed by the security zone to engage in these activities. Small entities and the maritime public will be advised of implementation of these security zones via public notice to mariners or notice of implementation published in theFederal Register.

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

This rule does not have Tribal implications under Executive Order13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

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

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

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

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under addresses.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

Cargill entered into a Federal consent decree with EPA and a number of states, including Indiana, to resolve a complaint filed against the company in the United States District Court for the District of Minnesota. The consent decree was lodged on September 1, 2005. It covers 24 Cargill facilities in 13 states.

Paragraph 15 of the consent decree requires, among other things, that Cargill submit permit applications to applicable permitting authorities that will contain annual SO2emission limits for the facilities and boilers listed in Appendix B of the decree. Appendix B lists four boilers at the Hammond facility—Numbers 6, 7, 8, and 10. It requires the retirement of Boiler Number 7, while removing the emission limits, recordkeeping requirements, and reporting requirements for the other three boilers. All four boilers have been permanently shutdown.

Paragraph 27 of the consent decree requires SO2emission reductions at the Hammond facility to be achieved through the installation of pollution control technologies and the implementation of emission reduction projects to meet a level of control specified for the sources in Appendix L of the decree.

Indiana has revised SIP rule 326 Indiana Administrative Code (IAC) 7-4.1-5 to address these consent decree provisions.

Indiana revised Cargill's emission limits in 326 IAC 6.8-2-8 to remove the emission units that are no longer in operation at the Hammond facility. These revisions were not required by the consent decree, but were made to reflect the permanent shutdown of Cargill units—ten process sources and two natural gas-fired boilers. Those units now have no emission limits and, as such, they cannot be operated. Inaddition, Indiana has made changes in unit identification to reflect current operations.

The revisions to the SO2emission limits in 326 IAC 7-4.1-5 should result in improved air quality. There will no longer be emissions from the four boilers that Cargill has permanently shutdown, as referenced in Appendix B of the consent decree. In addition, there should be substantial SO2emission reductions resulting from the eight units required to be controlled in Appendix L of the consent decree. The revisions to the PM emission rule, 326 IAC 6.8-2-8, help to clarify the PM requirements for Cargill.

EPA, therefore, finds these revisions to the SO2and PM SIP rules acceptable.

As a result of the SO2emission reduction requirements in the consent decree, Cargill shutdown eight units and tightened emission limits on four other units. The total allowable SO2emissions rate from all Cargill units is now 622 pounds per hour lower. The revisions have the potential to reduce SO2emissions by 2730 tons per year.

Sulfur dioxide in the atmosphere can aggravate respiratory and cardiovascular disease. Sulfur dioxide emissions also contribute to acid rain and fine particulate matter formation.

Indiana also removed the PM emission limits for ten units that are permanently shutdown. The emission limit revisions do not cause a reduction in PM emissions as the units have already ceased operation, but they are indicative of the reduction in total allowable PM emissions that has occurred at the Cargill facility. The facility's cumulative allowable PM emissions are now 71 pounds per hour lower. That yields a potential annual reduction of 311 tons of PM emissions.

Particulate matter interferes with lung function when inhaled. Exposure to particulates can cause heart and lung disease. Particulate matter also aggravates asthma. Airborne particulate matter or PM is the main source of haze that causes a reduction in visibility.

EPA is approving revisions to the Indiana SIP. This consists of revisions of the PM emission rule, 326 IAC 6.8-2-8, and the SO2emission rule, 326 IAC 7-4.1-5.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of thisFederal Registerpublication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective June 13, 2011 without further notice unless we receive relevant adverse written comments by May 16, 2011. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective June 13, 2011.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules sectionof today'sFederal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

1. Identify the rulemaking by docket number and other identifying information (subject heading,Federal Registerdate and page number).

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

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

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

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

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

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

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

On January 10, 2008, EPA issued new, more stringent National Regulations for Gasoline Dispensing Facilities at 40 CFR part 63, subpart CCCCCC, (73 FR 1945), promulgated under section 112 of the Act. The gasoline dispensing standards in that rule apply nationwide to subject sources of hazardous air pollutants identified in 40 CFR 63.11111.

Indiana adopted new requirements to reflect the revised Federal regulations. These revisions: (1) Remove past compliance dates (326 IAC 8-1-3); (2) extend applicability of the rules to facilities statewide with a through-put of ten thousand (10,000) gallons per month or greater (326 IAC 8-4-1); and (3) add new requirements for filling gasoline storage tanks (326 IAC 8-4-6).

Indiana placed notices for public comment periods in the Indiana Register first on June 27, 2007 and the second notice on June 3, 2009. Indiana placed notices of public hearing dates in four newspapers on July 31, 2009. Indiana then held a public hearing on the proposed rule on September 2, 2009. There were no comments. The proposed rule was published in the Indiana Register on September 23, 2009, and no comments were received. A second notice of hearing was published in the Indiana Register on September 23, 2009 and a second public hearing was held on November 4, 2009. No comments were received. The final rule was adopted on November 4, 2009.

The revisions to Indiana's stage I vapor recovery rule, 326 IAC 8-1-3, 326 IAC 8-4-1 and 326 IAC 8-4-6, are approvable because they are consistent with the Act and applicable EPA regulations, and should result in additional VOC emission reductions. A description of the rule revisions follows:

326 IAC 8-1-3Compliance schedules—This section deletes subsections 8-1-3 (d) and (e), which had allowed for compliance date extensions, because the applicable dates have long past.

326 IAC 8-4-1Applicability—This section expands the applicability to all gasoline storage tanks at a gasoline dispensing facility with a through-put of ten thousand (10,000) gallons per month or greater.

326 IAC 8-4-6Gasoline dispensing facilities—Section 6(a)(8) decreases the tank cut off size required to meet the regulatory standards for fueling from two thousand, one hundred seventy six (2,176) to nine hundred forty-six (946) liters (575 to 250 gallons). Section 6(b)(1) revises the requirements for submerged fill pipes for existing and newer tanks. Fill pipes installed before November 9, 2006 must be no more than twelve (12) inches from the bottom of the tank, and those installed after November 9, 2006 must be no more than six (6) inches from the bottom of the tank.

The expanded applicability and more stringent submerged fill requirements will result in additional VOC reductions.

EPA is approving into the Indiana SIP revisions the entire stage I and stage II vapor recovery rule. Although the only amendments to the rule affected are sections 326 IAC 8-1-3, 326 IAC 8-4-1, and 326 IAC 8-4-6, concerning stage I vapor recovery, and administrative changes to stage II vapor recovery rule, we are approving the entire rule for clarity and consistency.

We are publishing this action without prior proposal because we view this asa noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of thisFederal Registerpublication, we are publishing a separate document that will serve as the proposal to approve the State plan if relevant adverse written comments are filed. This rule will be effective June 13, 2011 without further notice unless we receive relevant adverse written comments by May 16, 2011. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective June 13, 2011.

Under the Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.

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

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today'sFederal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

In accordance with the CAA, Edmonson County, Kentucky; Huntington-Ashland, West Virginia-Kentucky; Lexington-Fayette, Kentucky; and Owensboro, Kentucky were designated as nonattainment for the 1-hour ozone NAAQS (effective January 6, 1992, 56 FR 56694).

On November 13, 1992, Kentucky submitted requests to redesignate the Edmonson County, Lexington-Fayette, and Owensboro 1-hour nonattainment Areas to attainment for the 1-hour ozone NAAQS. Subsequently, on November 12, 1993, Kentucky submitted a request to redesignate the Kentucky portion of the Huntington-Ashland Area to attainment for the 1-hour ozone NAAQS. In addition to the redesignation requests, Kentucky submitted the required ozone monitoring data and maintenance plans to ensure that the redesignated Areas would remain in attainment for the 1-hour ozone NAAQS for a period of 10 years after redesignation, consistent with the CAA section 175A(a).

EPA approved Kentucky's maintenance plans and requests to redesignate the Kentucky portion of the Huntington-Ashland Area (60 FR 33748; June 29, 1995); the Lexington-Fayette Area (60 FR 47089; September 11, 1995); the Edmonson County Area (59 FR 55053; November 3, 1994); and the Owensboro Area (60 FR 7124; February 7, 1995) for the 1-hour ozone NAAQS.

On April 30, 2004, EPA designated areas for the 1997 8-hour ozone NAAQS (69 FR 23858), and published the final Phase I Implementation Rule for the 1997 8-hour ozone NAAQS (69 FR 23951) (Phase I Rule). Daviess, Edmonson, Fayette, Greenup,1 Hancock and Scott Counties (including all portions that were previously designated nonattainment for the 1-hour ozone NAAQS) were designated as attainment for the 1997 8-hour ozone NAAQS, effective June 15, 2004.

As a consequence of their designations as attainment for both the 1-hour and 8-hour ozone standards, the Four Kentucky Areas (all 8-hour ozone attainment areas) were required to submit 10-year maintenance plans pursuant to section 110(a)(1) of the CAA and the Phase I Rule, 40 Code Federal Regulations (CFR) 51.905(a)(4). On May 20, 2005, EPA issued guidance as to how a state might fulfill the section 110(a)(1) maintenance plan obligation established by the CAA and the Phase I Rule (Memorandum from Lydia N. Wegman to Air Division Directors,Maintenance Plan Guidance Document for Certain 8-Hour Ozone Areas Under Section 110(a)(1) of Clean Air Act,May 20, 2005, hereafter referred to as “Wegman Memorandum”). Neither section 110(a)(1) nor any other provision of the CAA contains detail regarding the specific content of maintenance plans for these types of areas. EPA's Phase I Rule, in 40 CFR 51.905(a)(4) provides that section 110(a)(1) maintenance plans must include contingency measures.

On December 22, 2006, the United States Court of Appeals for the District of Columbia Circuit (DC Circuit) issued an opinion that vacated portions of EPA's Phase I Rule.See South Coast Air Quality Management District (SCAQMD)v.EPA,472 F.3d 882 (D.C. Cir. 2006). On June 8, 2007, in response to several petitions for rehearing, the DC Circuit Court clarified that the Phase I Rule was vacated only with regard to those parts of the Rule that had been successfully challenged. Of particular relevance, the Court vacated those portions of the Phase I Rule that provided for regulation of the 1997 8-hour ozone nonattainment areas designated under Subpart 1 (of part D of the CAA) in lieu of Subpart 2, among other portions of the Phase I Rule. The Court's decisions do not alter any 8-hour ozone attainment area requirements under the Phase I Rule for CAA section 110(a)(1) maintenance plans. EPA is thus finalizing its approvals of Kentucky's May 27, 2008, proposed SIP revisions as satisfying the section 110(a)(1) CAA requirements for plans that provide for implementation, maintenance, and enforcement of the1997 8-hour ozone NAAQS in the Four Kentucky Areas.

EPA is taking final action to approve SIP revisions incorporating the 110(a)(1) maintenance plans for the 1997 8-hour ozone NAAQS for the Four Kentucky Areas—Edmonson County, Greenup County, Lexington, and Owensboro. On May 27, 2008, Kentucky submitted these maintenance plans to ensure the continued attainment of the 1997 8-hour ozone NAAQS through the year 2020. In addition to reviewing the maintenance plans, EPA has reviewed the updated available air quality monitoring data for the Four Kentucky Areas and has confirmed, that based on the available data that these Areas continue to meet the 1997 8-hour ozone NAAQS. The table below shows the 2007-2009 design values for these attainment areas, based on complete, quality-assured and certified monitoring data. The table below also shows the preliminary data from 2010 which are consistent with continued attainment. The data are listed in EPA's Air Quality System database as the preliminary design value report. EPA does not anticipate any concerns regarding these data.

In this final action, EPA is also responding to adverse comments received, from the Sierra Club and Kentucky Environmental Foundation, regarding EPA's proposed rulemakings to approve these revisions, 74 FR 12567, March 25, 2009 (Greenup County Area, Lexington Area and Edmonson County Area); 75 FR 3183, January 20, 2010 (Owensboro Area); and 75 FR 16387, April 1, 2010 (Owensboro limited reopening of comment period). EPA proposed approval of the maintenance plans for the Four Kentucky Areas in two separate actions. This final rulemaking action is based on EPA's full review of relevant information and consideration of the comments received, and reflects EPA's conclusion, that these maintenance plans comply with section 110 of the CAA and EPA's implementing regulations. See 40 CFR 51.905(a)(4). EPA's analyses of Kentucky's SIP revisions for the Edmonson County, Greenup County, and Lexington Areas are described in detail in proposed and direct final rules published March 25, 2009 (74 FR 12774 and 74 FR 12567, respectively). Although EPA's direct final rulemaking was withdrawn on May 5, 2009 (74 FR 20601), due to the adverse comments received, EPA's proposed rulemaking remained in place. EPA's analysis for Kentucky's SIP revision for the Owensboro Area is described in detail in a proposed rule published on January 20, 2010 (75 FR 3183). Today's action responds to adverse comments received on EPA's March 25, 2009, and January 20, 2010, rulemakings, and finalizes those rulemakings. EPA's action approving the maintenance plan for each area is separate and independent of its approval of the plans for the other areas.

EPA received one set of adverse comments from the Sierra Club and the Kentucky Environmental Foundation (hereafter referred to as “the Commenters”). These comments address EPA's March 25, 2009, proposed and direct final rules to approve Kentucky's 110(a)(1) maintenance plans for the Edmonson County, Greenup County, and Lexington Areas. This same set of comments was submitted by the Commenters for EPA's January 20, 2010, proposed rule to approve Kentucky's 110(a)(1) maintenance plan for the Owensboro Area. Today's rulemaking takes final action on the maintenance plans for all Four Kentucky Areas. The following section of this notice summarizes the adverse comments received, and sets forth EPA's responses to the comments. (The complete comments are available in the docket for this rulemaking.)

Comment 1.The Commenters claim that EPA's proposed and direct final rules to approve Kentucky's 110(a)(1) maintenance plans for the Four Kentucky Areas “run contrary to Administrator's Jackson's promise that the U.S. Environmental Protection Agency decisions would henceforth be based on three guiding principles: transparency; use of sound science; and respect for rule of law.” The Commenters state that “[i]ssuing a direct final rule in which the actual rules are not knowable by reading theFederal Registernotice, or for that matter, the administrative record, is not a transparent process.” They further complain that EPA's proposal ignored the science of climate change and contravened statutory language.

Response 1.EPA disagrees with the Commenters' characterization of the content of theFederal Registernotice. The Commenters' contention that because the complete text of the SIP revisions is not included in theFederal Registernotice, EPA has failed to adhere to certain principles espoused by EPA Administrator Jackson is simply unsupported. EPA's rulemaking here has fulfilled the goals of transparency, sound science, and respect for the law. With regard to transparency, neither the CAA nor the Administrative Procedure Act mandates that theFederal Registernotice of proposed rulemaking, or final rulemaking action, include the complete text of the proposed SIP revisions. EPA's notice of proposed rulemaking satisfied the notice requirements by providing citations to the rules at issue, offering the SIP revisions for public review, and describing the subjects and issues involved in the SIP revisions. Because publication in theFederal Registeris costly and resource intensive, EPA makes every effort to provide key information in proposal notices while at the same time using Agency resources efficiently. EPA drafts rulemaking notices to enable public understanding of the subjects and issues at hand. All documents related to this rulemaking were available athttp://www.regulations.govunder the docket number EPA-R04-OAR-2007-1186, during the comment period for the proposed rulemaking actions. For a member of the public wishing to review the complete text of the SIP revisions, the notice of proposed rulemaking included instructions for obtaining access to the complete SIP revision. Inaddition, the public could also contact the EPA representative designated in the notice to obtain further information or answers to questions. Thus, the Commenters' contention that, because the complete text of the SIP revision was not included in theFederal Registernotice, EPA failed to adhere to EPA Administrator Jackson's three principles is simply unsupported.

EPA also rejects the Commenters' assertion that the rulemaking violates any of the three principles that have been espoused by EPA Administrator Jackson. EPA's adherence to Administrator Jackson's three principles (transparency, use of sound science, and respect for rule of law) is clearly reflected in the detailed information and explanations set forth in the proposals, direct final actions, and this final action, including the substantive responses to comments. As was discussed earlier in this notice, and is also discussed later in this response to comments section, EPA's approvals of the maintenance plans are supported by the CAA, its implementing regulations, and applicable guidance.

Comment 2.The Commenters assert that Kentucky DAQ has indicated that Greenup County, in the Huntington-Ashland Area, Jessamine County in the Lexington Area, and Edmonson County are violating the 2008 8-hour ozone NAAQS. Therefore, the Commenters state, that the public interest mandates that EPA quickly act to ensure that at the very least, the 1997 8-hour ozone NAAQS is maintained.

Response 2.The present rulemaking action addresses solely the maintenance of the 1997 8-hour ozone NAAQS for the Edmonson County, Greenup County, Lexington, and Owensboro Areas. EPA is approving, pursuant to CAA section 110(a), Kentucky's plans to assure continued maintenance of the 1997 8-hour ozone NAAQS in the Four Kentucky Areas. Attainment or maintenance of any subsequently adopted ozone NAAQS is not relevant to this rulemaking action, and therefore the issue raised by the Commenters is outside the scope of this rulemaking.

The 2008 8-hour ozone NAAQS, promulgated on March 12, 2008, is irrelevant to this rulemaking. EPA is currently reconsidering the 2008 8-hour ozone NAAQS, and has not yet designated areas for any subsequent NAAQS. Actions that EPA may take with regard to the 2008 (or a reconsidered) ozone NAAQS are separate from and independent of the actions now being taken to approve the 110(a)(1) maintenance plans for the Four Kentucky Areas in this rulemaking.

Comment 3.The Commenters assert that the maintenance plans do not ensure maintenance of the 1997 8-hour ozone NAAQS because there is no requirement that major stationary sources demonstrate that they do not cause or contribute to new violations of the 1997 8-hour ozone NAAQS. The basis for this assertion appears to be the Commenters' view that Kentucky's Prevention of Significant Deterioration (PSD) program does not require new or modified sources that trigger major PSD review due to an increase in emissions of nitrogen oxides (NOX) to demonstrate that they will not cause or contribute to a violation of the ozone NAAQS. The Commenters point to a specific facility and cite to a portion of the PSD application for that facility where volatile organic compounds (VOCs) are considered for the ozone analysis, but not NOX.

Response 3.On September 15, 2009, the Kentucky DAQ filed an emergency rule to immediately address the issue of NOXas a precursor for ozone for PSD purposes (which EPA required as part of a November 29, 2005, rulemaking for ozone implementation—70 FR 71612). Kentucky's emergency rule provides explicit requirements for major new sources and major modifications of existing sources of NOXto demonstrate that they will not cause or contribute to a violation of the ozone NAAQS. The emergency rule became effective immediately in Kentucky and was subsequently submitted to EPA for approval as a SIP revision. On April 1, 2010, EPA proposed approval of Kentucky's rule to address NOXas a precursor to ozone for PSD (75 FR 16388, April 1, 2010). EPA received adverse comments from the Sierra Club.2 On September 15, 2010 (75 FR 55988), EPA issued a final action responding to the adverse comments and approving the Commonwealth's rule to address NOXas a precursor to ozone for PSD as a revision to the Kentucky SIP. EPA thus believes that the concerns voiced by the Commenters in this rulemaking about alleged deficiencies in Kentucky's PSD program and the regulation of NOXas a precursor to ozone have been satisfactorily addressed and resolved.

Comment 4.The Commenters contend that the maintenance plans are inadequate because there is no consideration of the impacts that climate change will have on ozone levels. The comment makes reference to several publications, provides a discussion on the impact of weather on climate change and ozone, and concludes that failure to consider this important aspect of the problem would lead to an arbitrary result. The Commenters request that EPA evaluate the maintenance plans in light of the “increasing danger climate change will cause from ozone.”

Response 4.With regard to the comment that Kentucky's analysis improperly omits consideration of the affect of climate change on ambient ozone levels, EPA agrees that climate change is a serious environmental issue; however, EPA does not agree that the maintenance plans at issue in today's action cannot be approved without the climate change analysis outlined by the Commenters. One of the reports cited to by the Commenters (April 2009 “Assessment of the Impacts of Global Change on Regional U.S. Air Quality: A synthesis of climate change impacts on ground-level ozone,” page xxiv) concludes that, “[t]hese studies suggest that EPA's Office of Air Quality Planning and Standards should begin to consider climate change, for example, in the next update of EPA's ozone modeling guidance, especially for planning horizons in 2020 and beyond.” Although the EPA report cited in the comment indicates that climate change increases ozone concentrations in “substantial regions of the country,” the report also states that there are “pronounced differences in the broad spatial patterns of change” among the various modeling groups. While ozone concentrations may be affected as early as the 2020s (already after the date—2014—required to be addressed by these section 110(a) maintenance plans), most of the modeling groups did not simulate ozone concentration changes prior to the 2050s. Furthermore, the report itself states that “modeling uncertainties persist, and further research is needed.” More specifically, the report further states that “[c]urrent modeling uncertainties lead to disagreements about the spatial patterns of future changes in meteorological variables and, hence, the specific regional distributions of future ozone changes across the United States.” Several of the projected models, in fact, provide conflicting projections for the area inwhich Kentucky is located (see e.g., Fig. 3-1of the above mentioned EPA report). The report concludes “[t]hese studies suggest that EPA's Office of Air Quality Planning and Standards shouldbegin to considerclimate change, for example, in the next update of EPA's ozone modeling guidance, especially for planning horizons in 2020 and beyond.” (Emphasis added.) Thus, the report acknowledges that modeling guidance is not yet available for the type of area-specific analysis of effects of climate change on ozone concentrations required for SIP planning. EPA therefore believes it is premature to require a precise mathematical accounting in the SIP process for the effect of higher ambient temperatures due to climate change on ozone concentrations. EPA stands ready to reevaluate this position when the state of science and confidence in projection improve. Given the above, however, at this time, EPA cannot say Kentucky was in error when it did not model the potential impact of climate change on ozone in the Greenup County, Edmonson County, Lexington and Owensboro Areas as it developed maintenance plans for those areas.

Comment 5.The Commenters contend that Kentucky's maintenance plans ignore the possibility of changes in weather and emissions outside the covered counties. The Commenters also contend that the 2002 emissions inventory are not based on any actual emissions data gathered with continuous emissions monitors or verified with actual emissions from 2005 and 2008. Thus, the Commenters conclude that EPA's approval is arbitrary because the emissions forecasts are flawed. The Commenters claim that there are several reasons for the flaws, including alleged failures to properly consider the role of ozone and ozone precursor transport and of weather.

Response 5.Under 40 CFR 51.905(a)(4) section 110(a)(1), maintenance plans, like the one at issue here, must demonstrate maintenance of the 1997 8-hour NAAQS through 2014. Kentucky has voluntarily extended the coverage of its maintenance plans for the Four Kentucky Areas for an additional six years beyond the required maintenance period (through 2020). EPA has reviewed these plans and determined that they satisfy applicable requirements. The demonstrations are based upon actual emissions inventories, and projected emissions through 2020. These projections take into consideration population, state, local and federal emission controls, and other relevant factors. Unlike maintenance plans for nonattainment areas that are redesignated to attainment, for which section 175A of the CAA specifies express requirements, section 110(a)(1) maintenance plans for areas designated attainment are not subject to specific statutory maintenance plan requirements. In accordance with EPA guidance, however, Kentucky did undertake an analysis, summarized as follows, for certain emissions groups such as stationary sources, area sources and some mobile sources. Response 5, below, contains additional information responsive to Comment 4.

Utilizing Standard Industrial Codes (SIC), all point source emissions were projected based on growth factors calculated using Bureau of Economic Analysis (BEA) projection data for employment, as suggested by EPA and utilized for previous point source projections in similar contexts. The point source data provided SIC codes used to determine a short title description that matched the corresponding description found in the BEA data. The application of growth factors for each projection was then used for point sources. Appendix E to Kentucky's May 27, 2008, SIP revisions provide information on how point source projections were determined.

Area sources can be defined as those sources that are generally too small and/or too numerous to be handled individually in the point source inventory. Area source emissions were estimated by multiplying an emission factor by a known indicator of collective activity such as number of employees or population. For area source emission projections, population growth factors for each chosen year were calculated using an exponential formula in the EXCEL software. The application of these growth factors for each projection was then used for area sources. Information used to calculate growth factors, including population information used to project area sources, was provided by the University of Louisville Urban Data Center and can be found in Appendix F of Kentucky's May 27, 2008, SIP revisions.

The non-highway mobile category is broken down into three groups that include two- and four-cycle gasoline engines and diesel engines (other non-highway engines), railroad locomotives, and aircraft. Emissions are estimated by multiplying the base year inventory by a known indicator of collective activity such as fuel consumed or landing/takeoff operations. For locomotive and aircraft emission projections, population growth factors for each chosen year were calculated using the before mentioned formula. The application of these growth factors for each projection was then used for each of these non-highway categories. For other non-highway categories (e.g., industrial equipment, tractors, leaf blowers), EPA's nonroad model was used to determine the future year projections. Nonroad model and non-highway projection information can be found in Appendix G of Kentucky's May 27, 2008, SIP revisions. Updated minimum and maximum summer temperatures and ambient temperatures were utilized for input into the nonroad model. EPA Volume IV mobile source guidance was followed in determining the updated temperature data. Please see Appendix C of Kentucky's May 27, 2008, SIP revisions for specific temperature documentation.

The use of emissions inventories and emissions forecasts has long been an accepted method for evaluating maintenance of the NAAQS under section 175A for nonattainment areas and EPA's guidance advises its use for purposes of maintenance plans under CAA section 110(a)(1). The Courts have agreed with EPA's longstanding view that a maintenance demonstration for a nonattainment area, and a fortiori an attainment area, need not be based on modeling.Wallv.EPA,265 F.3d 426 (6th Cir. 2001);Sierra Clubv.EPA,375 F.3d 537 (7th Cir. 2004).See also66 FR 53094, 53099-53100 (October 19, 2001); 68 FR 25430-25431 (May 12, 2003).

In its guidance issued May 20, 2005, EPA explained that, “[t]he typical method that areas have used in the past to demonstrate that an area will maintain the 1-hour standard has been to identify the level of ozone precursor emissions in the area which is sufficient to attain the NAAQS and to show that future emissions of ozone precursors will not exceed the attainment levels.” Wegman Memorandum at pg. 4. The inventory and projections Kentucky provided in the maintenance plans at issue here use this method to demonstrate that the Areas will maintain the 8-hour ozone standards. Complete, quality-assured air quality monitoring data through the year 2009 for all of these Areas showed maintenance of the 1997 8-hour ozone NAAQS, and data available for 2010 indicate continued maintenance. Maintenance is demonstrated by showing that during the maintenance period the level of precursor emissions remains at or below the attainment level. Variations in weather are accounted for by the 3-year averaging required for finding of attainment (see e.g.,the 2004 attainment designation). The requirement that there be three years of quality-assured monitoring data to demonstrate attainment is theestablished mechanism by which EPA takes meteorological variability into account for purposes of determining attainment and maintenance. These issues have been addressed multiple times in a variety of EPA rulemakings and court decisions. Today's actions are consistent with EPA's longstanding interpretation of the maintenance plan requirements of the CAA.See e.g.,69 FR 21719 (April 22, 2004) (redesignation of the San Francisco area); 66 FR 53094, 53099 (October 19, 2001) (redesignation of the Pittsburgh-Beaver area); 68 FR 25418, 25430 (May 12, 2003) (redesignation of the St. Louis area); 40 CFR 50.9 and Appendix H (method for determining attainment of 1-hour standard; Appendix H states that three years of data is required); Appendix I (method for 8-hour standard; Appendix I contain similar statement);Sierra Clubv.EPA,375 F.3d 537, 539-543 (7th Cir. 2004) (discussing the modeling required for maintenance plans). Similarly, the Commenters' concerns about potential modifications of sources or new sources that may affect ambient levels are addressed by the New Source Review (NSR) and PSD programs, as well as by the NOx SIP call requirements and other programs designed to regulate pollutants both inside and outside the covered counties. As a result, and contrary to the Commenters' contention, EPA's review of the maintenance demonstrations considered the role of emissions from outside the area in maintenance of the standard in the Four Kentucky Areas. EPA took into account the relevant federal and state requirements that will help ensure that emissions from outside the area will not interfere with continued maintenance in the area. These include, among others, the NOx SIP Call, NSR/PSD requirements, and other regulations that control emissions from outside the Four Kentucky Areas. (See alsoResponse 8, below.)

The inventory and projections Kentucky provided in the maintenance plans use this method to demonstrate the Four Kentucky Areas will continue to maintain the 1997 8-hour ozone NAAQS. The inventory and emissions analyses performed by Kentucky were conservative, and reviewed by EPA, to ensure that they reasonably establish maintenance of the NAAQS pursuant to section 110(a)(1). EPA's review of Kentucky initial attainment inventories and inventory projections of future maintenance inventories confirms that maintenance will continue through the requisite period. Moreover, as is explained further below, the contingency measures portion of the maintenance plan provides a backstop for maintenance, functioning to correct a violation if, despite the projections, one should occur.

With regard to the analyses performed by Kentucky, the emissions inventory includes four components: Point, area, highway mobile and non-highway mobile sources. The Four Kentucky Areas were designated attainment for the 1997 8-hour ozone NAAQS in 2004 using 2001-2003 data. They had an option to choose one of the three attaining years to use as a base year for emission inventory purposes. For these SIP revisions, Kentucky chose to use 2002, an attainment year (for both the 8-hour and 1-hour ozone NAAQS), as the year for developing a new comprehensive ozone precursor emissions inventory from which projected emissions could be developed for 2005, 2008, 2011, 2014, 2017, and 2020. Maintenance is demonstrated by comparing the attainment year emissions to the emissions in the years listed above. The following is a summary of the emission projection methodology that was used to forecast emissions over the maintenance period; the docket includes a more detailed description of this methodology.

Point sources are defined as stationary sources that emit 10 or more tons per year (tpy) of VOC or 100 tpy or more of NOx or carbon monoxide (CO). Annual point source emissions data were used.3 Point source information is collected by Kentucky from a number of sources (including permitting information) and point source information was provided for utilizing SIC (Response 4, above, discusses the various sources of emissions information used by Kentucky). See also Appendix E of Kentucky SIP Revisions (specifically discussion regarding point source projections). Point source emission projections were based on growth factors calculated using BEA projection data for employment. The point source data provided SIC codes used to determine a title description that matched the corresponding description found in the BEA data. The application of growth factors for each projection was then used for point sources.

As mentioned above, area sources are those that are generally too small and/or too numerous to be handled individually in the point source inventory. The University of Louisville Urban Data Center provided information used to calculate growth factors, including population information used to project emissions from area sources. Two and four-cycle gasoline engines and diesel engines (non-highway engines), railroad locomotives and aircraft make up the non-highway mobile category. Emissions were estimated by multiplying the base year inventory by a known indictor of collective activity such as fuel consumed or landing/takeoff operations. For locomotive aircraft emission projections, population growth factors for each chosen year were calculated. For other non-highway categories such as industrial equipment and tractors, EPA's nonroad model was used to determine future year projections.

Daily Vehicle Miles Traveled (DVMT) and speeds for 2002 and the projection years were obtained from the Kentucky Transportation Cabinet and used to calculate highway mobile source emissions. EPA's MOBILE6.2 model was used to derive appropriate projection year emission factors that were multiplied by the corresponding DVMT to determine the projected highway mobile source emissions. The 1990 mobile emissions were recalculated using the updated MOBILE6.2 emissions model in order to standardize the comparison of the 1990 numbers with the 2002 and 2020 mobile emissions developed using this model. EPA agrees with the methodology used to develop the 2005 and 2008 on-road emissions as projected from the 2002 actual emissions and submitted in the SIP revisions. The projection methodology used to develop future year on-road mobile emissions found in the SIP revisions, combined with the fact that later determined actual emissions were considerably lower than already projected emissions, provides a strong basis for approval of these maintenance plans.

With respect to the Commenters' contention that attainment inventories were not based on actual emissions, in fact the 2002 emission inventories for the Greenup County, Owensboro, and Lexington Areas were based on actual point source emissions. There are no point sources in the Edmonson Area. (See page 2.1 of Appendix C of each Area's 110(a)(1) maintenance plan submittal.) At the time of the initial submission of these 110(a)(1) maintenance plans in 2008, the actual emissions for some source categories for 2005 and 2008 were not required to be submitted. The Consolidated EmissionsReporting Rule (CERR)4 (40 CFR part 51, subpart A) requires states to submit to EPA an emissions inventory for all source categories every three years and at the time the SIP revisions were due, only the 2002 emissions were available for states to use. See 40 CFR 51.30. Not every source is subject to continuous emissions monitoring, so the information on actual emissions may vary between source categories.

Kentucky has since reviewed the data and compared the actual emissions for 2005 and 2008 with the projected emissions for 2005 and 2008 which were contained in the maintenance plan submittals. This analysis is available in the docket for this final rulemaking. EPA reviewed Kentucky's analysis and found it reliable and compelling. The comparisons revealed that the emissions projected in Kentucky's maintenance plans for the Four Kentucky Areas were higher than the actual emissions by an average of 19 percent for VOC and 11 percent for NOx for 2005; they were higher by an average of 26 percent for VOC and 47 percent for NOx for 2008. Kentucky's maintenance plans demonstrated that, even using projections of emissions that were greater than those that actually occurred in these years, those projections remained below the attainment base-year inventories. Of course, the fact that the actual emissions that occurred in these Areas were substantially less than those that were projected provides further demonstration of continued maintenance. Thus, actual emissions data during the maintenance period have proven that Kentucky's projected emissions were very conservative, and confirm EPA's view that the plans provide adequate assurance of maintenance during the requisite period. In the future, EPA anticipates even further reductions of these ozone precursors. This information supports the position that Kentucky's emissions projections provided with the 110(a)(1) maintenance plans were conservative.

In addition to the assurance provided by the information above, which demonstrates the conservative nature of the emissions forecasts (which were supported by actual emissions data as explained in the previous paragraph), the contingency measures portion of maintenance plans serves as a backstop in the event that any of these Areas requires supplemental measures to maintain air quality. These contingency measures help to ensure that the Areas continue to maintain the NAAQS of concern and can quickly correct a violation should one occur. Kentucky's maintenance plans contain two types of such contingency measures for each of the Four Kentucky Areas. In the event that exceedances (as contrasted with actual violations) of the 8-hour ozone NAAQS are monitored in any portion of the maintenance area, or if periodic emission inventory updates reveal excessive or unanticipated growth greater than 10 percent in ozone precursor emissions, Kentucky will evaluate existing control measures to see if additional control measures should be implemented at that time. If a monitored violation occurs, Kentucky has committed to a contingency measure schedule where one or more contingency measures will be adopted within nine months and implemented within 18 months to bring the area back into attainment.

For the reasons discussed above, the Commenters have failed to identify a deficiency in the 110(a)(1) maintenance plans that warrants any action other than approval.

Comment 6.The Commenters state that the maintenance plans rely both on assuming that measures will be implemented in the future to decrease emissions and assuming that Kentucky will implement contingency measures if the maintenance plans do not achieve their objectives. Specifically, the Commenters argue that Kentucky used a Reid Vapor Pressure (RVP) in gasoline of 8.6 pounds per square inch (psi) in developing future emission levels even though an RVP of only 9.0 psi is legally required. The Commenters believe that the maintenance demonstration should be based on legal requirements rather than assumptions of over-compliance.

Response 6.The forecasting of emissions in a maintenance plan involves the use of reasonable, scientifically-based premises that form the basis for expectations of future emissions, the maintenance projections, and contingency measure requirements. It is not necessary here for EPA to accept or reject the Commenters' contentions regarding historically-based over-compliance with legal requirements. Even if EPA assumes, as the Commenters insist, that EPA evaluates maintenance using the less stringent RVP level of 9.0 psi, the Four Kentucky Areas all demonstrate continued maintenance. First, the Commenters' concern with the stringency of RVP levels does not pertain to the Greenup County Area, since Kentucky modeled only 9.0 psi for RVP for this Area, and did not assume a lower RVP. Thus, the Commenters' assertion regarding RVP levels more stringent than 9.0 psi applies only to the 110(a)(1) maintenance plans for the Edmonson County, Lexington and Owensboro Areas. For these Areas, EPA has received and evaluated additional information that responds to the Commenters' concern. Kentucky has demonstrated that the Edmonson County, Lexington and Owensboro Areas are projected to demonstrate continued maintenance of the 1997 8-hour ozone NAAQS with fuel modeled at either 9.0 psi (the statutory level) or at 8.6 psi (the level indicated by historical surveys that these Areas typically receive). This provides a modeled analysis showing a comparison of VOC and NOx emissions using both the 8.6 and 9.0 psi RVP gasoline. Table 2 below shows the difference in emissions for the Edmonson County, Lexington and Owensboro Areas at RVP levels model at both 8.6 psi and 9.0 psi.

The overall effect on VOC emissions of the difference between 8.6 and 9.0 psi RVP gasoline is 0.52 tpd or less for each of the projection years for the Edmonson County, Lexington, and Owensboro Areas. Further, each of the projected VOC emission inventories using 9.0 psi RVP gasoline is less than the baseline VOC emission inventory for the 2002 attainment year. Based upon these data, EPA concludes that the Edmonson County, Lexington, and Owensboro Areas' 1997 8-hour maintenance plans demonstrate continued maintenance with the use of either 8.6 or 9.0 psi RVP gasoline in these Areas. See also Approval Grant Parish 110(a)(1) Maintenance Plan, 72 FR 62579 (November 6, 2007) and 73 FR 8202 (February 13, 1008).

Comment 7.The Commenters state that Kentucky's maintenance plans included unidentified maximum achievable control technology (MACT) standards as sources of reductions of VOC. The Commenters assert that this analysis failed to consider that the MACT standards could result in the increase of NOX, VOC, and CO emissions due to the “energy penalty” from new emission control devices.

Response 7.The Commenters do not identify the specific impact of any “energy penalty” on maintenance of the 1997 8-hour ozone NAAQS in the Four Kentucky Areas. Energy inefficiencies, as explained by the Commenters, may apply to any number of pollutants and the Commenters did not provide information specifically addressing how an energy penalty would affect emissions reductions relevant to today's action. For purposes of responding to this comment, EPA considered the term “energy penalty” to refer to a reduction in energy output that might result in the increase of emissions.

In the 110(a)(1) maintenance plans at issue, Kentucky stated, “[t]he continued improvement and maintenance of the air quality in the [areas], as verified by the lack of violations of the 8-hour ozone standard, is due to the implementation of permanent and enforceable emission reductions * * *. The following information outlinesemission reduction measures that have occurred from 1990 through 2002, and those implemented after 2002 and projected to 2020.” Kentucky then lists Maximum Achievable Control Technology (MACT)—promulgated national emission standards for hazardous air pollutants (commonly referred to as “MACT standards”)—controls in this list of measures. With specific regard to that issue, Kentucky explained, “* * * (m)any of the [Hazardous Air Pollutants] HAPs under these industrial categories of controls are also VOCs and compliance with these new MACT standards as they are being promulgated will decrease VOC emissions from the affected industries * * *”. Based on discussions with Kentucky, EPA concludes that Kentucky's maintenance analyses do not rely on quantified reductions from MACT standards. Rather, the analyses simply recognize that implementation of MACT standards may result in collateral reductions of VOCs.5 For that reason, Kentucky listed “MACT” generally as part of the permanent and enforceable reductions in place in the Areas; however, Kentucky did not quantify those reductions numerically with regard to the maintenance plans at issue today and does not rely on them to demonstrate maintenance. EPA further notes that even if Kentucky had claimed reductions from MACT standards, the Commenters simply claim without any supporting information that an energy penalty will occur and will result in increased VOC emissions. Without additional specific information, EPA cannot conclude that there will be any energy penalty whatsoever.

In terms of the environmental benefit of the MACT standards, Kentucky's expectation that the implementation of the MACT standards will have an environmental benefit for ozone is reasonable. The Commenters do not provide information supporting the comment that installation of control technology will require more fuel to be burned such that emissions will increase. Additionally, the Commenters provide the example of the installation of carbon injection or a baghouse to control mercury; however, no emissions calculation based on a specific facility is provided. As a result, the Commenters have not demonstrated that a source will necessarily become less efficient because of these control technologies (as was stated in the comment); nor that Kentucky's maintenance plans are deficient for this reason. EPA believes that Kentucky's consideration of MACT standards was reasonable.

In the future, any collateral emission increases associated with a specific MACT standard control will be addressed during the actual implementation and permitting of sources. If for some reason the maintenance of the Areas appear compromised by any specific MACT standard in the future, the permitting and implementation process, as well as the triggers and measures in the contingency portion of the maintenance plans, should prevent or resolve any problem as expeditiously as practicable.

Comment 8.In further support of the comment regarding use of projected future emissions reductions, the Commenters assert that Kentucky appears to be relying upon reductions in NOXemissions from the Clean Air Interstate Rule (CAIR). The Commenters state that because CAIR is a cap and trade program, it is arbitrary to assume that sources will reduce emissions in every year between 2008 and 2020.

Response 8.CAIR was remanded to EPA, (North Carolinav.EPA,531 F.3d 896modified on reh'g,550 F.3d 1176 (D.C. Cir. 2008)), and the process of developing a replacement rule is ongoing. As a point of clarification, neither CAIR nor the remand of CAIR altered the requirements of the NOXSIP Call,6 which requires states to make significant, specific emissions reductions. See 63 FR 57356 (October 27, 1998).

All four of the Kentucky Areas attained the 1997 8-hour ozone NAAQS by 2002, without any reliance on reductions from CAIR, and before requirements under CAIR were implemented. Kentucky has demonstrated that the Four Kentucky Areas can maintain the 1997 8-hour ozone NAAQS without these requirements. Therefore, EPA believes that the Commenters' expressed concerns about Kentucky's reliance on NOXreductions from CAIR are misplaced, and Kentucky's demonstrations of maintenance under section 110(a)(1) do not depend upon them.

Although Kentucky did not rely on the remanded CAIR rule for either attainment or maintenance of the 1997 8-hour ozone NAAQS, the NOXSIP Call requirements provide additional assurance of maintenance in the Four Kentucky Areas. In addition, the anti-backsliding provisions of 40 CFR 51.905(f) specifically provide that the provisions of the NOXSIP Call, including the statewide NOXemission budgets, continue to apply after revocation of the 1-hour ozone NAAQS. For the maintenance plans that are the subject of today's actions, Kentucky appropriately does not rely on the remanded CAIR requirements.

Comment 9.Again, as support for the contention that Kentucky considered over-compliance in its maintenance plans, the Commenters explain that Kentucky included vehicle turnover in its consideration of maintenance, but state that there is no requirement for vehicle turnover in the counties covered by the maintenance plans. Thus, it is the Commenters' contention that there is no justification for including this factor in the projected future emissions.

Response 9.For the reasons described below, EPA disagrees that there is no justification for considering fleet turnover in emissions forecasts. Fleet turnover, the gradual, continuing process of new vehicles certified to tighter emissions standards replacing older vehicles, is a historic fact that has been central to estimating the benefits of federal and state emission control programs in SIPs and maintenance plans since the earliest motor vehicle emission controls were implemented. Fleet turnover will occur in the future as long as people continue to replace older vehicles with newer ones, and there is no reason to expect this historic practice to change.

The emission impacts of fleet turnover have been incorporated in every EPA-approved emission model including MOBILE6.2, the approved model for estimating motor vehicle emissions in SIPs and maintenance plans at the time of this analysis. Generally, the calculation of emissions in MOBILE6.2 is based upon the reasonable expectation that each year, the model year composition of the local motor vehicle fleet changes as new vehicles are purchased and enter the fleet and old vehicles are scrapped. This results in a decrease in fleet average NOx and VOC emissions each yearbecause older model year vehicles certified to less stringent emission standards leave the fleet and are replaced by newer vehicles certified to more stringent standards. The phase-in of new vehicle standards and the change in the average emissions of the vehicle fleet due to the replacement of older vehicles with newer ones are included in MOBILE6.2 for both past and future years.

Specific inputs for MOBILE6.2 can affect the rate of fleet turnover that the model calculates in future years. EPA has included language in the guidance document “Technical Guidance on the Use of MOBILE6.2 for Emission Inventory Preparation” (dated August 2004) to ensure that states make reasonable assumptions about the rate of fleet turnover in the future. As described in this guidance, projected rates of fleet turnover in the future should take into account historic fleet turnover in the area. That guidance states that it would not be reasonable for a state to assume that the rate of new vehicle purchases and fleet turnover in the future is higher than historic rates. However, EPA expects that states will make the reasonable assumption that residents will continue to purchase or lease new vehicles to replace old ones, at rates similar to historic rates, and that the average emissions of the fleet will decline as a result.

Comment 10.The Commenters complain that the contingency measures in the Kentucky maintenance plans are not automatically effective upon a triggering event. Specifically, the Commenters contend that in order to comply with the standards set out in the CAA and in the Wegman Memorandum, maintenance plans must require that a violation of the NAAQS, or a 10 percent increase in the emission inventory, or another triggering event that EPA develops, must result in automatically effective contingency measures. The Commenters appear concerned that the contingency measures outlined by Kentucky are “vague” and not automatically effective upon a triggering event. In support of the contention that the CAA requires that the contingency measures be in the SIP and automatically effective upon a trigger event, the Commenters cite two court cases:Sierra Clubv.EPA,356 F.3d 296 (D.C. Cir. 2004) andNatural Resources Defense Council (NRDC)v.EPA,22 F.3d 1125, 1134 (D.C. Cir. 1994).

Response 10.The CAA sets no specific requirements for section 110(a)(1) maintenance plans, not even that they contain contingency measures.EPA, in its implementing regulation, provides simply that a section 110(a)(1) maintenance plan “must include contingency measures.” EPA guidance in the Wegman memorandum, p. 7, states that contingency provisions should be aimed at promptly correcting violation of the NAAQS, and explains that the SIP should contain an enforceable commitment to adopt and implement contingency measures in a timely fashion once they are triggered. Consistent with this guidance, Kentucky's 110(a)(1) maintenance plans provide that in the event of a monitored violation of the 8-hour ozone NAAQS, Kentucky commits to adopt, within a specific amount of time (i.e., nine months), one or more of the 8 specific contingency measures listed in the plan. Kentucky's maintenance plan commits to implementing the contingency measures within 18 months. The Wegman Memorandum states “[t]he schedule for adoption and implementation should be as expeditious as practicable, but no longer than 24 months.” Kentucky's 18-month timeframe is consistent with the Wegman Memorandum.

The Wegman Memorandum goes on to explain that, in addition to the minimum trigger upon violation of the NAAQS, EPA recommends additional triggers could be used such as exceedance of the precursor emission levels upon which maintenance is based. This type of trigger is beneficial because it occurs prior to a violation. Kentucky has also included this type of additional trigger in its 110(a)(1) maintenance plans. If periodic emissions inventory updates reveal excessive or unanticipated growth greater than 10 percent in ozone precursor emissions, Kentucky has committed to evaluating existing control measures to see if any further emission reduction measures should be implemented at that time. By meeting the minimum requirement of adopting and implementing specific contingency measures upon a violation of the NAAQS and including additional triggers, Kentucky has sufficiently provided for contingency measures in its maintenance planning for the 1997 8-hour ozone NAAQS in the Four Kentucky Areas that are the subject of this notice.

The CAA itself does not expressly address contingency measures in section 110(a)(1) maintenance plans, much less require that any contingency measures be automatically effective, and the flexibility afforded to Kentucky ensures that the correct measure can be adopted in order to respond to the particular air quality issues causing the triggering event. While the triggering event directs the state to launch the process to adopt and implement a contingency measure, the state is also given some flexibility to determine which of the identified measures is best suited to address the particular air quality issue that must be corrected. This is reasonable, desirable, and consistent with how EPA and the states have addressed section 175A contingency measures in nonattainment areas that have been redesignated to attainment.

The Commenters' contention that the CAA requires something more than is being required by EPA in the 110(a)(1) maintenance plans at issue in today's action, finds no support in the statute itself.The maintenance plans at issue in this notice are 110(a)(1) maintenance plans for areas in attainment with the NAAQS at issue. Section 110(a)(1) contains no express requirement for maintenance plans for attainment areas to contain contingency measures, much less detail their content. Even where the CAA does require maintenance plans to have contingency measures—section 175A for nonattainment areas being redesignated to attainment—the CAA and its implementing regulations do not require that these measures be automatically effective upon a triggering event. Thus, neither a section 110 or 175A maintenance plan for an area that is attaining the NAAQS (attainment area or a redesignated maintenance area) is required to have fully adopted contingency measures that will take effect without further action by the state in order for the maintenance plan to be approved.

The Memorandum from John Calcagni to Air Division Directors, Procedures for Processing Requests to Redesignate Areas to Attainment, September 4, 1992—hereafter referred to as “Calcagni Memorandum,” and the Wegman Memorandum, are consistent with the applicable statutory and regulatory requirements. The Calcagni Memorandum states “[t]hese contingency measures are distinguished from those generally required for nonattainment areas under section 172(c)(9) and those specifically required for ozone and CO nonattainment areas under sections 182(c)(9) and 187(a)(3), respectively.” While contingency measures that are required for nonattainment areas under sections 172(c)(9) and section 182(c)(9) must be already adopted so that they can be effective upon a triggering event for a nonattainment area that fails to meet its reasonable further progress (RFP) or attainment deadlines, this is not required for section 110(a)(1) or 175A maintenance plans. The Commenters donot provide any statutory or regulatory citations for their positions.

Even for maintenance plans for nonattainment areas that are being redesignated to attainment, section 175A requires only that the state include contingency measures, as EPA deems necessary, to promptly correct any violation of the NAAQS that occurs after redesignation of the area. 42 U.S.C. 7505a(d) (Emphasis added.) EPA's interpretation that maintenance plan contingency measures need not be fully adopted has been followed since 1992. The Sixth Circuit inGreenbaumv.EPA,endorsed the Calcagni Memorandum's statements regarding contingency measures for 175A maintenance plans. Specifically, the Court stated that under 175A, EPA “has been granted broad discretion by Congress in determining what is `necessary to assure' prompt correction.” 370 F.3d at 540. Given the latitude provided maintenance plan contingency measures for nonattainment areas being redesignated, EPA's treatment of section 110(a)(1) maintenance plans for attainment areas is eminently justified and reasonable.

In support of their contention that contingency measures be automatically effective, the Commenters cite to two cases and not any statutory or regulatory provisions. In the first,Sierra Clubv.EPA,356 F.3d 296 (D.C. Cir. 2004), the D.C. Circuit evaluated a conditional approval for nonattainment area SIPs—the case did not concern maintenance plans for attainment areas and did not address contingency measures for attainment areas. In the second,NRDCv.EPA,22 F. 3d 1125 (D.C. Cir. 1994), the Court was also evaluating a conditional approval as well as various EPA rules regarding, in part, vehicle inspection and maintenance programs promulgated pursuant to the 1990 amendments to the CAA. The pinpoint citation provided by the Commenters leads to a discussion on interim milestones to satisfy the conditional approval (under CAA section 110(k)(4)).Id.at 1134.

With regard to the Commenters' contention that the contingency measures are “vague,” below is a summary of the contingency measures included in the maintenance plans. In the event of a monitored violation of the 8-hour ozone NAAQS, Kentucky commits to adopt, within nine months, one or more of the following contingency measures to re-attain the NAAQS.

• Stage I Vapor Recovery;

• Stage II Vapor Recovery;

• Basic Vehicle Emissions Testing Program;

• Open burning ban during summer ozone season;

• Restriction of certain roads or lanes to, or construction of such roads or lanes for use by, passenger buses or high-occupancy vehicles;

• Trip-reduction ordinances;

• Employer based transportation management plans, including incentives;

• Programs to limit or restrict vehicle use in downtown areas, or other areas of emission concentration, particularly during periods of peak use;

• Programs for new construction and major reconstructions of paths or tracks for use by pedestrians or by non-motorized vehicles when economically feasible and in the public interest.

Comment 11.The Commenters assert that EPA has not demonstrated that the Greenup maintenance plan, without contingency measures, “will not interfere with attainment and reasonable further progress in the other portion of Greenup County” or in Boyd County, Kentucky.

Response 11.The Commenters provide no explanation of the basis for their concern that Greenup County's maintenance plan might somehow interfere with attainment in the other portion of Greenup County or in Boyd County, and thus EPA is uncertain of the basis for the Commenters' statements. Nonetheless, EPA reviews below the relationship between Greenup County and Boyd County with respect to the 1-hour and 8-hour ozone standards. With regard to the 1-hour ozone NAAQS, in 1992, Boyd County and a portion of Greenup County7 were designated nonattainment as the Kentucky portion of the Huntington-Ashland 1-hour ozone Area. In 1995, the Kentucky portion of the Huntington-Ashland Area was redesignated to attainment for the 1-hour ozone NAAQS, and under CAA section 175A, EPA approved Kentucky's 1-hour ozone maintenance plan for the Area. In 2004, during a national designations process, EPA evaluated the Huntington-Ashland Area for the 1997 8-hour ozone NAAQS. EPA designated Boyd County nonattainment for the 8-hour ozone NAAQS. Further, EPA, and designated attainment the portion of Greenup County that was formerly part of the Huntington-Ashland 1-hour ozone Area.

As part of that designations process, EPA made the determination that the portion of Greenup County that was in the former 1-hour ozone area did not contribute to violations of the 8-hour ozone NAAQS in the Huntington-Ashland 1997 8-hour ozone nonattainment Area (including Boyd County). 69 FR 23858, 23906 (April 30, 2004). The portion of Greenup County that was designated attainment for the 1-hour ozone NAAQS was never subject to the 175A maintenance plan because it was never designated nonattainment. EPA has no information indicating that Greenup County Area's maintenance of both the 1-hour and 8-hour NAAQS will interfere with attainment and RFP of Boyd County.

Moreover, based on monitoring data for 2004-2006, EPA determined that the 1997 8-hour ozone nonattainment area for Huntington-Ashland attained the 1997 8-hour ozone NAAQS, and in 2007, EPA redesignated the Area to attainment. (72 FR 43172, August 3, 2007). EPA is not aware of any subsequent 8-hour ozone violations in Boyd County (as part of the 1997 8-hour ozone maintenance area for Huntington-Ashland) which is subject to an approved section 175A 1997 8-hour ozone maintenance plan. There is no evidence that any portion of Greenup County has interfered with or will interfere with 8-hour ozone attainment in the Huntington-Ashland Area (including Boyd County). Today's final approval of the Greenup County Area's section 110(a)(1) maintenance plan will do nothing to increase emissions or interfere with attainment in other areas. Further, the Greenup County Area's 110(a)(1) maintenance plan projects 2020 out-year emissions for Greenup County are expected to decrease bytwenty-six percent for VOCs and by fifty-one percent for NOX, compared to the base year 2002. The Greenup County Area was attaining the 1997 8-hour ozone NAAQS in 2002 based on measured ambient air quality monitoring data, and the emissions inventory future years is shown to remain below the 2002 baseline. Boyd County, as part of the Huntington-Ashland Area, has now been redesignated to attainment for the 1997 8-hour ozone NAAQS. There is no indication that Greenup County is interfering or will interfere with continued maintenance in Boyd County. EPA believes that the emissions reductions expected to continue in Greenup County establish that Greenup County will not interfere with attainment throughout the County or in the Huntington-Ashland Area (Boyd County). Thus, EPA disagrees with the Commenters' contentions regarding Greenup County.

Comment 12.The Commenters incorporated by reference comments previously submitted to EPA regarding the Edmonson County maintenance plan by the Karst Environmental Education and Protection, Inc. (KEEP). Additionally, the Commenters state that EPA must consider the KEEP comments. The KEEP comments, which are directed specifically to the Edmonson County maintenance plan only, expressed concerns about: whether emissions inventories and projections properly considered Mammoth Cave National Park and the Nolin River Lake area; highway emissions inventories and projections not including unique traffic generators (again identifying specific areas); emissions inventories and projections not including gasoline and other fuel handling activities associated with Nolin Lake and Mammoth Cave National Park; non-highway emissions inventories and projections not considering watercraft at Nolin Lake; points source emission inventories and projections not appearing complete (certain sources identified); and that the contingency measures should be implemented immediately or no later than three months.

Response 12.On August 24, 2004, Kentucky submitted an update to its original maintenance plan for the 1-hour ozone NAAQS for the Edmonson County Area as required by section 175A(b) of the CAA. EPA published a proposed and direct final rule on December 17, 2004 (69 FR 75473), to approve Kentucky's updated maintenance plan for the Edmonson County Area. During the public comment period on these rulemakings, EPA received adverse comments from KEEP. In response to these comments, EPA withdrew its direct final rulemaking and Kentucky subsequently withdrew its submitted update to its 1-hour ozone maintenance plan for Edmonson County.

The KEEP comments related to emissions inventories and projections submitted in 2004 for the 1-hour ozone maintenance plan and are not relevant to the 110(a)(1) maintenance plan that Kentucky submitted for the Edmonson County Area for the 1997 8-hour ozone NAAQS. For the development of the 110(a)(1) maintenance plan, Kentucky was required to use the most up-to-date information. Thus the data used to develop the 110(a)(1) maintenance plan in 2007 are not equivalent to the data used in 2003 to develop the 175A maintenance plan. The KEEP comments, as a result, do not address the data in the current 8-hour maintenance plan, and thus do not apply to today's action. Nor are they “adverse” to the instant action because they are not relevant to this action.

The only issue that might even conceivably be deemed to relate to today's action is KEEP's comment regarding the 18-month period for implementation of the 1-hour contingency measures. KEEP argued that section 175A contingency measures for nonattainment areas being redesignated should be implemented in no less than three months based upon the fragile and unique terrestrial and subterranean resources of Mammoth Cave National Park. Response 10 above discusses implementation timeframes for contingency measures under sections 175A and 110(a)(1). As noted above, the CAA does not prescribe contingency measures for attainment area maintenance plans, and the EPA regulation that requires them does not specify any deadlines, much less a three month deadline. EPA's guidance in the Wegman Memorandum is consistent with longstanding EPA practice with respect to implementation of contingency measures. Moreover, the State and EPA may at any time determine that additional measures are necessary to assure correction of a violation; however, at this time, there is no such violation and the proposed contingency measures timeframe is consistent with the applicable requirements. EPA notes that the Edmonson Area has consistently attained the 1-hour ozone NAAQS since 1994 and has been attaining the 8-hour ozone NAAQS since 2004. Thus, EPA sees no reason to require more stringent contingency measure deadlines than those in the submitted maintenance plan.

Comment 13.The Commenters state thatEPA must include contingency measures that are triggered based on ambient monitoring and not just emission inventories. The Commenters reference other maintenance plans in Kansas and Missouri; however, no citations were provided. The Commenters also state that the requirements must be written into the CFR at 52.920(e) in order for this to be a clear requirement.

Response 13.The Commenters' concerns are misplaced. The Wegman Memorandum states that a section 110(a)(1) maintenance plan should, “include contingency provisions, as necessary, to promptly correct any violation of the NAAQS that occurs (51.905(a)(3)(iii) and (4) (ii)).” Wegman Memorandum at pg. 7. In the 110(a)(1) maintenance plans, Kentucky in fact commits to taking action based on both ambient monitoring data and emission inventory data. Thus, the Commenters are incorrect in contending that contingency measures are not triggered by the results of ambient monitoring. In the event that exceedances of the 1997 8-hour ozone NAAQS are measured in any portion of the maintenance areas (ambient monitoring data of greater than 0.084 ppm ozone), or if periodic emission inventory updates reveal excessive or unanticipated growth greater than 10 percent in ozone precursor emissions, Kentucky commits to evaluate existing control measures to see if any further emission reduction measures should be implemented at that time. In the event of a monitored violation of the NAAQS, Kentucky commits to adopting, within nine months, one or more of a number of measures listed in the maintenance plan and states that all regulatory programs will be implemented within 18 months. The measures listed in the maintenance plans include but are not limited to such measures as Stage 1 Vapor Recovery, Stage II Vapor Recovery, open burning bans during ozone season, and road restrictions. Kentucky also states that it reserves the right to implement other contingency measures if new control programs should be developed or deemed more advantageous. The maintenance plans thus require contingency measures to be triggered upon either ambient monitoring or changes in the emissions inventory projections. The maintenance plans being approved today will be referenced in the appropriate provisions of 40 CFR 52.920.8 These provisions do notexplicitly state all the requirements of the plan, but rather, cite to the existence of that plan and note, among other information, the date of approval by EPA. Copies of Kentucky's plan can be obtained at the EPA Region 4 Office or athttp://www.regulations.govunder the docket number: “EPA-R04-OAR-2007-1186.”

Comment 14.The Commenters argue thatKentucky must be required to update the emission inventories and that the maintenance plans should include mandatory language requiring Kentucky to prepare emission inventories every three years using a defined methodology. The Commenters state that these requirements should appear in 40 CFR 52.920(e).

Response 14.Section 110(a)(2)(F) of the CAA provides that SIPs are to require “as may be prescribed by the Administrator * * * (ii) periodic reports on the nature and amounts of emissions and emissions-related data from such sources.”Emission inventories are important for the efforts of state, local, and federal agencies to attain and maintain the NAAQS for criteria pollutants. Pursuant to its authority under section 110 of the CAA, EPA has long required SIPs to provide for the submission, by states to EPA, of emission inventories containing information regarding the emissions of criteria pollutants and their precursors. EPA codified these requirements in 40 CFR part 51, subpart Q in 1979 and amended them in 1987. The 1990 Amendments to the CAA revised many of the provisions of the CAA related to the attainment of the NAAQS and the protection of visibility in mandatory Class I Federal areas (certain national parks and wilderness areas). These revisions established new periodic emission inventory requirements applicable to certain areas that were designated nonattainment for certain pollutants.

The Commonwealth of Kentucky stated that it would use the actual emissions developed through its submittal to EPA per the CERR. The CERR was published in theFederal Registeron Monday, June 10, 2002 (67 FR 39602) (found in 40 CFR part 51, subpart A). Emissions inventory guidance for the preparation of these inventories is located in the EPA website (http://www.epa.gov/ttnchie1/publications.html). The purpose of the CERR is to simplify reporting, offer options for data collection and exchange, and unify reporting dates for various categories of criteria pollutant emission inventories. The rule applies to state and local agencies and consolidates the emission inventory reporting requirements found in various parts of the CAA. States are required to prepare a comprehensive state-wide inventory every three years.See40 CFR 51.30. The first three-year inventory was for the year 2002. The latest CERR inventories were developed for 2005 and 2008 (which were used by Kentucky as was discussed previously). Due to the CERR and Kentucky's commitments in the maintenance plans, there is no need for additional mandatory language or commitments requiring the preparation of emission inventories every three years using a defined methodology. Kentucky will be updating its emission inventories every three years, pursuant to the methodology outlined in the CERR.

Comment 15.The Commenters assert that the maintenance plans should require a monitor in Scott County, in the Lexington Area. The Commenters contend that a monitor operated in Scott County until 2005, and that in 2005 it monitored violations of the 1997 8-hour ozone NAAQS. The Commenters questioned the rationale for removing the Scott County monitor and stated that 40 CFR 52.920(e) should require that an additional monitor be placed in Scott County.

Response 15.EPA addresses this comment in the context of today's approval of the maintenance plan for the Lexington Area. The Commenters' expressed concerns about the Scott County monitor are without foundation. First, contrary to the Commenters' contention, at the time it ceased operation, the Scott County monitor at issue was not violating the 1997 8-hour ozone NAAQS. Moreover, the monitor was shut down because it no longer met siting criteria requirements. Finally, the monitor was an additional special purpose monitor (SPM), that was supplemental to the State's monitoring network, and therefore its continued operation was not required to maintain an adequate monitoring network. These points are discussed in greater detail below.

First, contrary to the Commenters' contention, the Scott County monitoring site was not violating, but in fact had the lowest design value of the four sites in the metropolitan statistical area (MSA) at the time it ceased operation. The 2002-2004 design value for the 8-hour ozone NAAQS was 0.066 parts per million, far below the 1997 8-hour ozone NAAQS. Thus the Commenters are in error when they assert that the Scott monitor was violating the 8-hour ozone NAAQS prior to the time it ceased monitoring. The last time the Scott Monitor registered a violation of the 8-hour ozone standard was in 1996.

Second, the last siting inspection at the Sadieville site in 2004 revealed that the site no longer met the siting requirements for ozone, as per 40 CFR part 58, Appendices D and E. For example, one applicable siting criteria is that the monitor be set back a certain amount from a tree or tree line to ensure proper air flow.See, e.g.,40 CFR part 58, Appendix E. Monitors that fail to meet applicable siting requirements are not appropriate for use in determining compliance with the NAAQS. Because it was an optional SPM, and not a monitor required for the network to be approved, it was not moved to a new site, but ceased operating at the end of the 2004 ozone season.

Third, for the Lexington-Fayette, Kentucky MSA, the Commonwealth operates two State and Local Air Monitoring Stations (SLAMS) ozone monitors: one in Lexington and one in Nicholasville. From April 1993 until October 2004, Kentucky operated an ozone monitor in Sadieville, Scott County. The Sadieville ozone air monitoring station was located off KY Hwy 32 at the Scott County #2 Fire Station (AQS number 21-209-0001). It was designated as a SPM. A SPM is one that allows the capability of providing monitoring for complaint studies, modeling verification, and compliance status for short-term studies. The monitoring data may be reported to EPA, provided that the monitor(s) and station(s) meet the requirements of the SLAMS network. The Sadieville site represented population exposure on an urban scale; its main objective was to evaluate compliance with and/or progress made towards meeting the ozone NAAQS. Because Kentucky's SLAMS network already met all federal requirements for siting and design, this SPM in Sadieville reflected Kentucky's effort to exceed the EPA's siting requirements for ozone.

EPA has determined that Kentucky currently meets the monitoring requirements for ozone as required in 40 CFR part 58, Appendices A, C, D, E, and G. The Kentucky SLAMS consist of a network of monitoring stations whose size and distribution are largely determined by the monitoring requirements for NAAQS comparison and the needs of monitoring organizations to meet their respective SIP requirements. The SLAMS stations must meet requirements that relate to four major areas: Quality assurance, monitoring methodology, samplinginterval, and siting of instruments/instrument probes. The Areas affected by today's action include five monitors in locations consistent with federal requirements. Thus, at this time, there does not appear to be any rationale for placing a new monitor in Scott County. Every year, Kentucky is required to evaluate its current monitoring network consistent with 40 CFR 58.10. This process is subject to public notice and comment. For today's action, the monitoring network meets applicable requirements.

Pursuant to section 110(a)(1) of the CAA, EPA is taking final action to approve as revisions to Kentucky's SIP the maintenance plans for the 1997 8-hour ozone NAAQS for the Edmonson County, Greenup County, Lexington and Owensboro Areas, which were submitted by Kentucky on May 27, 2008. These maintenance plans ensure continued attainment of the 1997 8-hour ozone NAAQS for these Areas through the year 2020. After evaluating the Commonwealth's submittals and the comments received on the proposed rulemaking with respect to these plans, EPA has determined that each of these maintenance plans meets the applicable requirements of the CAA and EPA regulations, and is consistent with EPA policy.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, these actions:

• Are not “significant regulatory actions” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Are not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Status:The meeting will be open to the public.

Purpose:The purpose of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas (Committee) is to establish criteria and a comprehensive methodology for Designation of Medically Underserved Populations and Primary Care Health Professional Shortage Areas, using a Negotiated Rulemaking (NR) process. It is hoped that use of the NR process will yield a consensus among technical experts and stakeholders on a new rule for designation of medically underserved populations and primary care health professions shortage areas, which would be published as an Interim Final Rule in accordance with Section 5602 of the Affordable Care Act, Public Law 111-148.

Agenda:The meeting will be held on Wednesday, May 18; Thursday, May 19; and Friday, May 20. It will include a discussion of various components of a possible methodology for identifying areas of shortage and underservice, based on the recommendations of the Committee in the previous meeting. The Friday meeting will also include development of the agenda for the next meeting. Members of the public will have the opportunity to provide comments during the meeting on Friday afternoon.

Requests from the public to make oral comments or to provide written comments to the Committee should be sent to Nicole Patterson at the contact address above at least 10 days prior to the first day of the meeting, Wednesday, May 18. The meetings will be open to the public as indicated above, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed above at least 10 days prior to the meeting.

Background

Under 49 U.S.C. 31315(b) and 31136(e), FMCSA may grant exemptions from many of the Federal Motor Carrier Safety Regulations (FMCSRs) for a two-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level of safety that would be achieved absent such exemption” (49 CFR 381.305(a)).

FCSG applied for an exemption from FMCSA's cargo securement requirements specified in 49 CFR 393.120 to allow motor carriers to comply with the pre-January 1, 2004, cargo securement regulations (then at 49 CFR 393.100(c)) for the transportation of groups of metal coils with eyes crosswise. FMCSA published notice of the exemption application on June 14, 2010, and asked for public comment (75 FR 33667).

On September 27, 2002, FMCSA published a final rule revising the regulations concerning protection against shifting and falling cargo for commercial motor vehicles (CMVs) engaged in interstate commerce (67 FR 61212). The new rules were based on the North American Cargo Securement Standard Model Regulations, the motor carrier industry's best practices, and recommendations presented during a series of public meetings involving U.S. and Canadian industry experts, Federal, State, and Provincial enforcement officials, and other interested parties. Motor carriers were required to ensure compliance with the rule by January 1, 2004.

The September 2002 final rule established detailed requirements for a number of specific commodities (logs; dressed lumber; metal coils; paper rolls; concrete pipe; intermodal containers; automobiles, light trucks and vans; heavy vehicles, equipment and machinery; flattened and crushed vehicles; roll-on/roll-off containers; and large boulders). These commodities were identified in public meetings during the development of the model regulations as causing the most disagreement between industry and enforcement agencies. The commodity-specific requirements for these items supersede the general rules when additional requirements are given for a commodity listed in those sections. This means all cargo securement systems must meet the general requirements, except to the extent that a commodity-specific rule imposes additional requirements for the securement method to be used.

Currently, 49 CFR 393.120 specifies requirements for the securement of one or more metal coils which, individually or grouped together, weigh 5,000 pounds or more. Metal coils can be transported with eyes vertical, lengthwise, or crosswise.

Unlike the requirements for securing coils with eyes vertical (49 CFR 393.120(b)) and lengthwise (49 CFR 393.120(d)), the current securement requirements for coils with eyes crosswise (49 CFR 393.120(c)) only speak ofindividual coils;there are no specific requirements for securingrows of coils.As such, a motor carrier transporting a row of coils with eyes crosswise must secure each coil as an individual coil in accordance with 49 CFR 393.120(c).

FCSG noted that the regulations in place prior to January 1, 2004 directly addressed the securement of groups of coils loaded with eyes crosswise. Section 393.100(c) read as follows:

FCSG stated that, without a temporary exemption, adherence to the existing regulations at 49 CFR 393.120(c)—i.e.,treating each coil as an individual coil—places a burden on the motor carrier to carry significantly more coil bunks and timbers to secure each coil in a raised bunk off the deck. FCSG argued that individual securement of each coil produces no added safety benefit (but increases securement complexity in terms of coil bunks and timbers) compared to the “unitized” securement of multiple coils with eyes crosswise in rows in contact each other in the longitudinal direction. FCSG stated that securing groups of coils in this manner would allow the load to be unitized while still meeting the aggregate working load limit requirements of 49 CFR 393.106(d).

FCSG is working cooperatively with the North American Cargo Securement Harmonization Forum to effect these changes in the North American Cargo Securement Model Regulation, which both the U.S. and Canada have committed to use to update both the FMCSRs and Canada's National Safety Code 10. FCSG argued that the “unitized” securement of adjacent coils with eyes crosswise was deemed safe prior to the January 2004 revisions to the cargo securement regulations and should be still be considered safe today.

For the reasons stated above, FCSG requested that motor carriers be allowed to comply with the pre-January 2004 cargo securement provisions (then 49 CFR 393.100(c)) during the period of the exemption, if granted. FCSG believes that utilization of the pre-January 2004 regulations will allow carriers transporting metal coils to maintain a level of safety that is equivalent to the level of safety achieved without the exemption. A copy of FCSG's application for exemption is available for review in the docket of this notice.

FMCSA received two comments to the published exemption notice.

1. Richard Moskowitz responded on behalf of the American Trucking Associations (ATA), a large trade association representing State CMV associations. ATA supported the FCSG application for exemption and noted that the preamble to the September 2002final rule did not explain why the previous provision governing the transportation of unitized coils with eyes crosswise was being omitted. ATA agreed with FCSG's assertion that there is no additional safety benefit from securing rows of metal coils with eyes crosswise and in contact each other as individual coils under the current 49 CFR 393.120(c).

2. Gerald A. Donaldson, Ph.D., commented on behalf of the Advocates for Highway and Auto Safety (Advocates) in opposition to the FCSG application, arguing that the exemption would (1) undermine the current cargo securement regulation, and (2) place the traveling public in an increased risk of catastrophic events involving the ejection or dislodgement of heavy metal coils weighing up to 40,000 pounds. Advocates stated that FCSG does not cite any independently gathered, credible evidence to support the claim that a “unitized” carriage of coils as described by the applicant is just as safe as separate, independent securement of these coils through the use of tiedowns in conjunction with bunks, chocks, or cradles. Advocates commented that granting the application for temporary exemption would essentially reject the recommendations produced by the deliberations of leading cargo securement experts from the U.S. and Canada that led to the development of the North American Cargo Securement Model Regulation.

Advocates noted that FMCSA relied on two research studies “in proposing and adopting new cargo securement regulations that specifically addressed, in considerable detail, the need to ensure the independent securement of each transverse coil in the `suicide arrangement' of multiple rows of such coils.” Advocates stated that both the 1995 Illinois Transportation Research Center report entitled “Analysis of Rules and Regulations for Steel Coil Truck Transport: Final Report” and the 1997 Canadian Council of Motor Transport Administrators (CCMTA) report entitled “Tests On Methods of Securement for Metal Coils” “explicitly evaluate the need for intervening blocks, chocks, or cradles for each transverse coil so that excessive forces are not generated during vehicle and cargo acceleration (which is non-linear as acceleration force increases) that place excessive demands on tiedowns.” Advocates stated that the cargo securement requirements for metal coils are “based on both static and dynamic tests and are of record.”

FMCSA Response:

As a result of rulemaking petitions submitted by various parties, FMCSA published a final rule on June 22, 2006, amending its September 2002 final rule concerning protection against shifting and falling cargo (71 FR 35819). Among other things, this rule amended the definition of metal coil to read“an article of cargo comprised of elements, mixtures, compounds, or alloys commonly known as metal, stamped metal, metal wire, metal rod, or metal chain that are packaged as a roll, coil, spool, wind, or wrap, including plastic or rubber coated electrical wire and communications cable.”This revised definition meant that the commodity-specific rules for securing metal coils would apply to a wider variety of coils. Some of these products are substantially lighter than coils of flat sheet metal and can therefore be transported in groups on a single vehicle without causing violations of interstate truck (or axle) weight limits designed to protect pavements and bridges from damage and excessive wear and tear.1

While the two reports cited by Advocates examined various aspects of metal coil securement, it is important to note that neither of these studies discussed or evaluated—either analytically or through actual testing—the securement of rows of coils grouped together with eyes crosswise. Instead, each of the reports cited by Advocates evaluated only the securement of single coils with eyes vertical, crosswise, or lengthwise.

• The 1995 Illinois Transportation Research Center report on steel coil transport consists of (1) a 1994 field survey at seven Illinois vehicle scale locations, and (2) engineering analyses of metal coil securement through rigid body dynamics analysis, scaled model testing, and finite element analysis. At the time of that report, there was no specific definition of metal coils in the FMCSRs. Further, the term “suicide arrangement” in the Illinois Transportation Research Center report was used as an anecdotal reference only, and was not supported by crash or fatality data that showed CMV drivers to be at a higher risk in the event of a crash in which rows of metal coils grouped together with eyes crosswise were transported and secured according to the pre-2004 rules. While the report recommended a number of amendments to the cargo securement regulations for metal coils, none of these recommendations questioned the then-existing securement requirements for groups of coils with eyes crosswise, or identified specific changes necessary to improve the securement of groups of coils with eyes crosswise.

• The metal coils tested as part of the 1997 CCMTA report weighed individually 18,220 lbs, 23,200 lbs, and 44,400 lbs. These coils could not be tested in groups, since any substantial grouping would push the trailer over the 34,000-pound tandem axle weight allowed on the Interstate System. Like the Illinois Transportation Research Center report, the CCMTA report provided a number of recommendations for the securement of metal coils. Similarly, none of these recommendations questioned the then-existing securement requirements for groups of coils with eyes crosswise, or addressed specific changes necessary to improve the securement of groups of coils with eyes crosswise.

Advocates stated that “Granting the exemption would * * * essentially reject the recommendations produced by the deliberations of leading cargo securement experts from the U.S. and Canada conducted over several years that supported strengthening securement requirements in numerous respects.” Representatives of both FMCSA and CCMTA who served on the North American Cargo Securement Harmonization Committee, including the Chairman for the subcommittee on metal coil securement, have been contacted regarding this issue. Each of these representatives has confirmed that the lack of specific securement methods for rows of coils grouped together with eyes crosswise appears to have been an inadvertent omission when the Model Regulation was developed. Subsequently, given that no such requirements exist in the Model Regulation, no requirements for this loading pattern were included in the 2002 revisions to the FMCSRs. This omission has been brought to the attention of the North American Cargo Securement Harmonization Public Forum for consideration.

FMCSA acknowledges that FCSG did not present specific studies or data concerning the safety impact of granting this exemption. However, for the reasons discussed above, the Agency believes that granting the temporary exemption to allow securement of rows of metal coils loaded to contact each other in the longitudinal direction, with relative motion between coils and between coils and the vehicle prevented by tiedown assemblies and timbers, provides a level of safety that is equivalent to, or greater than the level of safety achieved without the exemption.

FMCSA has decided to grant FCSG's exemption application. FMCSA encourages any party having information that motor carriers utilizing this exemption are not achieving the requisite level of safety immediately to notify the Agency. If safety is being compromised, or if the continuation of the exemption is not consistent with 49 U.S.C. 31315(b) and 31136(e), FMCSA will take immediate steps to revoke the exemption.

Based on its evaluation of the application for an exemption, FMCSA has decided to grant FCSG's exemption application. The Agency believes that the level of safety that will be achieved using the pre-2004 cargo securement regulations to secure of rows of metal coils with eyes crosswise during the 2-year exemption period will likely be equivalent to, or greater than, the level of safety achieved without the exemption.

The Agency hereby grants the exemption for a two-year period, beginning April 12, 2011, and ending April 12, 2013.

During the temporary exemption period, motor carriers must meet the following requirements while still meeting the aggregate working load limit requirements of 49 CFR 393.106(d).

Interested parties possessing information that would demonstrate that motor carriers using the cargo securement exemption for rows of metal coils with eyes crosswise are not achieving the requisite statutory level of safety should provide that information to the Agency, which will place it in Docket No. FMCSA-2010-0177. We will evaluate any such information, and, if safety is being compromised or if the continuation of the exemption is not consistent with 49 U.S.C. 31315(b)(4) and 31136(e), will take immediate steps to revoke this exemption.

During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with or is inconsistent with this exemption to allow the securement of metal coils loaded with eyes crosswise, grouped in rows, in which the coils are loaded to contact each other in the longitudinal direction with respect to a person operating under the exemption.

Viewing wild marine mammals is a popular recreational activity for both tourists and local residents. In Washington, killer whales (Orcinus orca) are the principal target species for the commercial whale watch industry (Hoyt 2001, O'Connoret al.2009). Since monitoring of this population segment has begun, the number of whales peaked at 97 animals in the 1990s, and then declined to 79 in 2001. At the end of 2010 there were 86 whales. NMFS listed the Southern Resident killer whale distinct population segment (DPS) as endangered under the ESA on November 18, 2005 (70 FR 69903). In the final rule announcing the listing, NMFS identified vessel effects, including direct interference and sound, as a potential contributing factor in the recent decline of this population. Based on monitoring data regarding the large number of vessels in close proximity to the whales (i.e.,within1/2mile), research results regarding behavioral and acoustic impacts caused by vessels, and the risk of vessel strikes, NMFS is concerned that some whale watching activities may harm individual killer whales, potentially reducing their fitness and increasing the population's risk of extinction.

Killer whales in the eastern North Pacific have been classified into three forms, or ecotypes, termed residents, transients, and offshore whales. Resident killer whales live in family groups, eat salmon, and include the Southern Resident and Northern Resident communities. Transient killer whales have a different social structure, are found in smaller groups and eat marine mammals. Offshore killer whales are found in large groups and their diet is largely unknown. The Southern Resident killer whale population contains three pods—J, K, and L pods—and frequents inland waters of the Pacific Northwest. During the spring, summer, and fall, the Southern Residents' range includes the inland waterways of Puget Sound, Strait of Juan de Fuca, and Southern Strait of Georgia. Little is known about the winter movements and range of Southern Residents. Their occurrence in coastal waters extends from the coast of central California to the Queen Charlotte Islands in British Columbia. The home ranges of transients, offshore whales, and Northern Residents also include inland waters of Washington and overlap with the Southern Residents.

There is a growing body of evidence documenting effects from vessels on small cetaceans and other marine mammals. The variety of whale responses include stopping or reducing feeding, resting, and social interaction (Bakeret al.1983; Bauer and Herman 1986; Hall 1982; Krieger and Wing 1984; Lusseau 2003a; Constantineet al.2004; Arcangeli and Crosti 2009; Christiansenet al.2010); abandoning feeding, resting, and nursing areas (Jurasz and Jurasz 1979; Deanet al.1985; Glockner-Ferrari and Ferrari 1985, 1990; Lusseau 2005; Norriset al.1985; Salden 1988; Forest 2001; Morton and Symonds 2002; Courbis 2004; Bejderet al.2006); altering travel patterns to avoid vessels (Constantine 2001; Nowaceket al.2001; Lusseau 2003b, 2006; Timmelet al.2008); relocating to other areas (Allen and Read 2000); changes in acoustic behavior (Van Parijs and Corkeron 2001); and masking communication signals (Jensenet al.2009.) One study found that marine mammals exposed to human-generated noise released increased amounts of stress hormones that have the potential to harm their nervous and immune systems (Romanoet al.2004). In some studies, however, researchers have found that marine mammals display no reaction to vessels (Watkins 1986; Nowaceket al.2003) or concluded that there is no correlation between vessel effects and survival or reproduction (Weinrich and Corbelli 2009).

Several scientific studies in the Pacific Northwest have documented disturbance of resident killer whales by vessels engaged in whale watching. Several researchers have reported short-term behavioral changes in Northern and Southern Resident killer whales in the presence of vessels (Kruse 1991; Kriete 2002; Williamset al.2002a, 2002b, 2006, 2009; Footeet al.2004; Bainet al.2006, Holtet al.2009, Lusseauet al.2009, Wielandet al.2010), although many studies do not address whether it is the presence and activity of the vessel, the sounds the vessel makes, or a combination of these factors that disturbs the animals. Individual animals can react in a variety of ways to nearby vessels, including swimming faster, adopting less predictable travel paths, making shorter or longer dives, moving into open water, and altering normal patterns of behavior (Kruse 1991; Williamset al.2002a, 2009, 2010; Bainet al.2006; Norenet al.2007, 2009; Lusseauet al.2009).

Some studies have looked at effects on behavior at specific vessel distances. In those studies, vessels were underway during active approaches or may have been parked in the path or stopped close to the whales as part of a leapfrogging sequence (i.e.,a vessel repeatedly speeds ahead of the whales, makes a 90 degree turn to intercept the path of the whales and waits for the whales to approach). Many of these studies included both motorized and non-motorized (e.g.,sail boats and kayaks) in assessing the impacts of vessels on the behavior of the whales.

Approaches within 100 yards (91.4 m): Research results indicate that killer whale behavior changes from vessel approaches within 100 yards (91.4 m) include changes in swimming patterns, changes in respiratory patterns, reduced time spent foraging, and increased surface active behaviors, such as tail slaps (Bainet al.2006, Norenet al.2007, 2009; Williamset al.2002a, Lusseauet al.2009). Norenet al.(2007, 2009) reported the highest frequency of surface active behaviors when the nearest vessel was within 75 to 99 meters in 2005. Lusseauet al.(2009) reported a significant decrease in overall time spent foraging and significant increase in overall time spent traveling when vessels were present within 100 yards (91.4 m). Williamset al.(2002a) found that experimental vessel approaches at 100 meters (about 100 yards (91.4 m)) resulted in whales covering 13 percent more distance along a less direct route than before the vessel approached. Foraging female whales swam 25 percent faster and changed direction more often when approached by the experimental boat as compared to the observations before the boat approached.

Approaches within 200 to 400 yards (182.9 to 365.8 m): Research results also indicate that killer whale behavior can be affected by approaches at distances greater than 100 yards (91.4 m) (Lusseauet al.2009; Norenet al.2007, 2009; Williamset al.2009). One study reported similar types of effects (i.e.,increased direction changes, increased respiratory intervals and transitions between activity states) from vessels within 400 yards (365.8 m) of whales as compared to vessels within 100 yards (91.4 m), although to a lesser degree. This study did not report if the effects of vessels within 400 yards (365.8 m) were from vessels close to the 100-yard (91.4 m) distance (i.e.,at 101 yards), at a 200-yard (182.9 m) distance or further away (i.e.,399 yards) (Bainet al.2006). Lusseauet al.(2009) also reported a reduction in time spent foraging when vessels were within 400 yards (365.8 m). Norenet al.(2007, 2009) reported the highest frequency of surface active behaviors when the closest vessels were within 100 yards (91.4 m) in 2005 and the highest frequency of surface active behaviors when the closest vessel was within 125 to 149 yards (114.3 to 136.2 m) in 2006, as compared to situations when the closest vessel was further away.

The long term effects of these behavioral responses are less well known (Williamset al.2006), although researchers have estimated the physiological consequences of behavioral responses by calculating the energetic costs of the behaviors observed when vessels are present. Williamset al.(2006) estimated that killer whales expended slightly more energy in the presence of all types of vessels. The behavior exhibited in the presence of vessels would require approximately 3 percent more energy than behavior in the absence of vessels. The increased energy expenditure may be less important than the reduced time spent feeding and the resulting likely reduction in prey consumption. From their observations, Williamset al.(2006) calculated that lost feeding opportunities could result in an 18 percent decrease in energy intake in the presence of all types of vessels compared to when vessels are absent.

In addition, researchers have also looked at the number of boats and how smaller or larger numbers of boats present affects the behavioral responses of killer whales (Williams and Ashe 2007; Giles and Cendak 2010). Giles andCendak (2010) analyzed killer whale behavior in high and low boat density conditions. Based on the distribution of number of vessels within 1,000 yards (914.4 m) of the focal group, low boat density was defined as five or fewer vessels within 1,000 yards (914.4 m) and high density was greater than five vessels within 1,000 yards (914.4 m). Whales spent significantly less time foraging in high boat density conditions (approximately 17 percent of time) compared to low boat density conditions (approximately 25 percent of time). Whales were also significantly more likely to remain foraging in low boat density conditions, indicating that the whales discontinued foraging when boat density was high. The effect of boat density was significant only when the whales were foraging, which may be the behavior state most susceptible to disturbance by high numbers of vessels.

Increased energetic costs from behavioral disturbance and reduced foraging can decrease the fitness of individuals (Lusseau and Bejder 2007). Increased energy expenditure or disruption of foraging could result in poor nutrition. Poor nutrition could lead to reproductive or immune effects or, if severe enough, to mortality (Dierauf and Gulland 2001; Trites and Donnelly 2003). Interference with foraging and nutritional stress can affect growth and development, which in turn can affect the age at which animals reach reproductive maturity, fecundity, and annual or lifetime reproductive success (Trites and Donnelly 2003). Vessels in the path of the whales can interfere with important social behaviors such as prey sharing (Ford and Ellis 2006) or with behaviors that generally occur in a forward path as the whales are moving, such as nursing (Kriete 2007). Interference with behaviors including prey sharing and communication could also change social cohesion and foraging efficiency and therefore the growth, reproduction, and fitness of individuals.

Killer whales generally have a range of hearing from 1 to 100 kHz (Szymanskiet al.1999) and this wide frequency range of hearing makes killer whales susceptible to effects from a wide range of sounds, including sound produced by vessels. Sound modeling has been used to estimate distances at which vessel sound would cause behavioral responses for killer whales (Erbe 2002). Erbe (2002) predicted that the sounds of fast boats (greater than 50 km/h [31 miles/hour]) would be audible to killer whales at distances of up to 16 kilometers (10 miles) and cause behavioral responses within 200 meters (0.12 miles or 219 yards). For boats moving at slow speeds (10 km/h [ 6.2 miles/hour]), sound would be audible within 1 kilometer (0.62 miles or 1,094 yards) and cause behavioral changes within 50 meters (55 yards).

Human-generated sounds may mask or compete with and effectively drown out clicks, calls, and whistles made by killer whales, including echolocation (signals sent by the whales that bounce off objects in the water and provide information to the whales) used to locate prey and other signals the whales rely upon for communication and navigation. High frequency sound generated from recreational and commercial vessels moving at high speed in the vicinity of whales may mask echolocation and other signals the species rely on for foraging (Erbe 2002; Holt 2009), communication (Footeet al.2004, Weilandet al.2010), and navigation. Sounds directly in front of the whale (i.e.,in their path) would have the greatest impact on the whales ability to hear important sounds. Masking of echolocation would reduce foraging efficiency (Holt 2009), which may be particularly problematic if prey resources are limited. Holt (2009) reviewed the current knowledge and data gaps regarding sound exposure in Southern Resident killer whales. The review provides an overview of acoustic concepts, killer whale sound production, ambient sound levels in Haro Strait (Veirs and Veirs 2006), sound propagation in killer whale habitats, effects of sound exposure, and assessment of likely acoustic impacts on the Southern Residents. Holt used data on ambient sound and characteristics and sound levels of several different types of vessels (Hildebrandet al.2006) to analyze impacts on the effective range of killer whale echolocation in detecting a salmon. The vessel sounds were recorded at idle, when powering up, and at cruise speeds (17 to 31 knots). The review concluded that vessel noise was predicted to significantly reduce the range at which echolocating killer whales could detect salmon in the water column. Holt (2009) reported that the detection range for a killer whale echolocating on a Chinook salmon could be reduced 88 to 100 percent by the presence of a moving vessel within 100 yards (91.4 m) of the whale. The detection range was reduced 38 to 90 percent when different vessels were operating at different speeds 200 and 400 yards (182.9 and 365.8 m) from the whales. Reduction in detection ranges decreased with greater distance from the whales and this was the case for both fast (cruise) and slower (powering up) vessels.

Additionally, prey sharing has recently been identified as an important feature of Northern Resident killer whale foraging (Ford and Ellis 2005). Masking sound from vessels could affect the ability of whales to coordinate their feeding activities, including searching for prey and prey sharing. A study by Footeet al.(2004) on Southern Resident killer whales in the San Juan Islands identified that all three pods increased the duration of their primary communication call when vessels were present. This appears to be a recent development, which Footeet al.(2004) attributed to increased vessel traffic and subsequent engine noise reaching a threshold above which whales compensated with longer duration of calls to overcome the vessel noise (Footeet al.2004). Wielandet al.(2010) also reported increased call durations, but for a larger number of call types (16 out of 21 calls) in a similar comparison. Holtet al.(2009) found that killer whales increase their call amplitude in response to vessel noise.

Killer whales may also be injured or killed by collisions with passing ships and powerboats, primarily from being struck by the turning propeller blades (Visser 1999, Fordet al.2000, Visser and Fertl 2000, Baird 2001, Carrettaet al.2001, 2004; Van Waerebeeket al.2007). Some animals with severe injuries eventually make full recoveries, such as a female described by Fordet al.(2000) that showed healed wounds extending almost to her backbone. A 2005 collision of a Southern Resident with a commercial whale watch vessel in Haro Strait resulted in a minor injury to the whale, which subsequently healed. From the 1960s to 1990s (Baird 2002) only one resident whale mortality from a vessel collision was reported for Washington and British Columbia. However, additional mortalities have been reported since then. In March of 2006, the lone Southern Resident killer whale, L98, residing in Nootka Sound for several years, was killed by a tug boat. While L98 exhibited unusual behavior and often interacted with vessels, his death demonstrates the risk of vessel accidents. Several mortalities of resident killer whales in British Columbia in recent years have been attributed to vessel collisions (Gaydos and Raverty 2007).

Vessel effects were identified as a factor in the ESA listing of the Southern Residents (70 FR 69903; November 18, 2005) and are addressed in the Recovery Plan (73 FR 4176; January 24, 2008), which is available on our Web page athttp://www.nwr.noaa.gov/.

The Marine Mammal Protection Act (MMPA), 16 U.S.C. 1361et seq.,contains a general prohibition on take of marine mammals. Section 3(13) of the MMPA defines the term take as “to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal.” Except with respect to military readiness activities and certain scientific research activities, the MMPA defines the term harassment as “any act of pursuit, torment, or annoyance which—(i) Has the potential to injure a marine mammal or marine mammal stock in the wild, [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

In addition, NMFS regulations implementing the MMPA further define the term take to include: “the negligent or intentional operation of an aircraft or vessel, or the doing of any other negligent or intentional act which results in disturbing or molesting a marine mammal; and feeding or attempting to feed a marine mammal in the wild” (50 CFR 216.3).

The MMPA provides limited exceptions to the prohibition on take for activities such as scientific research, public display, and incidental take in commercial fisheries. Such activities require a permit or authorization, which may be issued only after agency review.

The ESA, 16 U.S.C. 1531-1543, prohibits the take of endangered species. Section 3(18) of the ESA defines take to mean “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct.” Both the ESA and MMPA require wildlife viewing to be conducted in a manner that does not cause take.

NMFS has developed specific regulations under the MMPA and ESA for certain marine mammal species in particular locations. Each rule was based on the biology of the marine mammals and available information on the nature of the threats. NMFS has regulated close vessel approaches to large whales in Hawaii, Alaska, and the North Atlantic and created buffer zones to protect Steller sea lions and has experience enforcing these regulations. There are exceptions to each of these rules.

In 1995, NMFS published a final rule to establish a 100 yard (91.4 m) approach limit for endangered humpback whales in Hawaii (60 FR 3775, January 19, 1995). While available scientific information did not provide precise information on a single distance at which vessels disturbed the whales, NMFS established the 100 yard approach regulation based on its experience enforcing the prohibition of harassment (i.e.,activities that were initiated or occurred within 100 yards (91.4 m) of a whale had a high probability of causing harassment). In 2001, NMFS published a final rule (66 FR 29502, May 31, 2001) to establish a 100 yard (91.4 m) approach limit for endangered humpback whales in Alaska that included a speed limit when a vessel is near a whale. The approach regulations included approach, by any means, including interception of the path of the whales. NMFS adopted the 100 yard distance to maintain consistency with the published guidelines and with the regulations that existed for viewing humpback whales in Hawaii. NMFS considered some form of speed restrictions to reduce the likelihood of mortality or injury to a whale in the event of a vessel/whale collision. For practical and enforcement reasons, NMFS included a slow safe speed standard, rather than a strict nautical mile-per-hour standard, in the rule.

In 1997, NMFS published an interim final rule to prohibit approaching endangered North Atlantic right whales closer than 500 yards (457.2 m) (62 FR 6729, February 13, 1997). The purpose of the 500-yard (457.2 m) approach regulation was to reduce the current level of disturbance and the potential for vessel interaction and to reduce the risk of collisions. In addition to collision injuries or mortalities, NMFS listed other vessel impacts, including displacing cow/calf pairs from nearshore waters, expending increased energy when feeding is disrupted or migratory paths rerouted, and turbulence associated with vessel traffic, which may indirectly affect right whales by breaking up the dense surface zooplankton patches in certain whale feeding areas. To further reduce impacts to North Atlantic right whales from collisions with ships, NMFS recently published a final rule to implement speed restrictions of no more than 10 knots applying to all vessels, except those operated by or under contract to Federal agencies, 65 ft (19.8 m) or greater in overall length in certain locations, and at certain times of the year along the east coast of the U.S. Atlantic seaboard (73 FR 60173; October 10, 2008).

On November 26, 1990 (55 FR 49204), NMFS listed Steller sea lions as “threatened” under the ESA and the listing included regulations prohibiting vessels from operating within buffer zones 3 nautical miles around the principal Steller sea lion rookeries in the Gulf of Alaska and the Aleutian Islands. The regulations prohibit vessels from operating within the 3-mile buffer zones, with certain exceptions. Similarly, people are prohibited from approaching on land closer than1/2mile or within sight of a listed Steller sea lion rookery. NMFS created the buffer zones to (1) Restrict the opportunities for individuals to shoot at sea lions; (2) facilitate enforcement of this restriction; (3) reduce the likelihood of interactions with sea lions, such as accidents or incidental takings in these areas where concentrations of the animals are expected to be high; (4) minimize disturbances and interference with sea lion behavior, especially at pupping and breeding sites; and (5) avoid or minimize other related adverse effects.

In addition to these specific regulations, NMFS has provided general guidance for wildlife viewing so that the activities are not likely to cause take. This is consistent with the philosophy of responsible wildlife viewing advocated by many federal and state agencies to allow the public to observe the natural behavior of wild animals in their habitats without causing disturbance (seehttp://www.watchablewildlife.org/andhttp://www.watchablewildlife.org/publications/marine_wildlife_viewing_guidelines.htm).

Each of the six NMFS Regions has developed recommended viewing guidelines to educate the public on how to responsibly view marine mammals in the wild and avoid causing a take. These guidelines are available on line at:http://www.nmfs.noaa.gov/prot_res/MMWatch/MMViewing.htm.The “Be Whale Wise” guidelines developed for marine mammals by the NMFS Northwest Regional Office and partners are also available at:http://www.bewhalewise.org/guidelines/.

Be Whale Wise is a transboundary effort to develop and update guidelines for viewing marine wildlife. NMFS has partnered with monitoring groups, commercial operators, whale advocacy groups, U.S. and Canadian government agencies and enforcement divisions over the past several years to promote safe and responsible wildlife viewing practices through the development of outreach materials, training workshops, on-water education and public service announcements. The 2009 version of the Be Whale Wise guidelines recommends that boaters parallel whales no closer than 100 yards (91.4 m), approach animals slowly from the side rather thanfrom the front or rear, and avoid putting the vessel within 400 yards (365.8 m) in front of or behind the whales. The guidelines also recommend vessels reduce their speed to less than 7 knots within 400 yards (365.8 m) of the whales, and to remain on the outer side of the whales near shore. In 2008 a state law with similar language to the current approach and “park in the path” guidelines (RCW 15.77.740) was enacted to protect Southern Resident killer whales in Washington State waters.

San Juan County, Washington, identifies two voluntary no-boat areas off San Juan Island on their Marine Stewardship Area maps, although this is separate from the Be Whale Wise guidelines. The first is a1/2mile (∼800 m)-wide zone along a 1.8 mile (3 km) stretch of shore centered on the Lime Kiln lighthouse on the west coast of San Juan Island. The second is a1/4mile (∼400 m)-wide zone along much of the west coast of San Juan Island from Eagle Point to Mitchell Point. These areas, totaling approximately 3.8 square miles, facilitate shore-based viewing and reduce vessel presence in an area used by the whales for feeding, traveling, and resting.

NMFS supports the Soundwatch boater education program, an on-water stewardship and monitoring group, to help develop and promote the Be Whale Wise guidelines and monitor vessel activities in the vicinity of whales. Soundwatch reports incidents when the guidelines are not followed and there is the potential for disturbance of the whales (Koski 2004, 2006, 2007, 2008, 2009, 2010a, 2010b). Soundwatch reported that the mean number of vessels following a given group of whales increased from five boats in 1990 to an average of about 15 to 20 boats within1/2mile of the whales during May through September, for the years 1998 through 2010 (Osborneet al.1999; Baird 2001; Erbe 2002; Marine Mammal Monitoring Project 2002; Koski 2004, 2006, 2007, 2008, 2009, 2010a, 2010b), with a peak of 22 vessels around the whales in 1998 and 2003 and a steady decline from 22 vessels in 2003 to an average of 14 vessels in 2010. Soundwatch identified potential reasons for the decline in average number of boats, including economic conditions and fewer opportunities for fishing, as well as a pattern of groups of whales that are spread out in the action area so that vessels are also spread out. Soundwatch remains with one group of whales and records vessel counts around the group and therefore would not count all boats spread out with multiple groups of whales (Koski 2010b).

At any one time, the observed numbers of commercial and recreational whale watch boats around killer whales can be much higher than the mean number of vessels. For example, sources other than Soundwatch have reported that 107 vessels followed one Southern Resident pod (Lien 2000); 76 boats simultaneously positioned around a group of 18 whales from K pod (Baird 2002); and local media reported up to 500 vessels came out on the weekends to view a group of whales from L pod in Dyes Inlet during the fall of 1997. Although the average number of whale watch vessels within1/2mile is lower than what was observed in these three cases, the extreme nature of these events illustrates the degree to which killer whales can captivate the public's interest in the Pacific Northwest and the level of vessel effects that may occur.

Over the last several years, the whale watch season has extended in length, with vessels accompanying whales for more hours of the day and more days of the year. It is not uncommon for Southern Residents or transient killer whales to be accompanied by many boats throughout much or all of the day with peak numbers of attending vessels in late morning and mid-afternoon during the busiest whale watching months of July and August (Koski 2007). In recent years, U.S. and Canadian commercial whale watch vessels have made up from 24 percent (2010) to over 50 percent (2004) of the vessels observed within a1/2-mile radius of the whales (Koski 2006, 2007, 2010b).

Soundwatch observers also report incidents when recreational and commercial whale watching vessels, as well as other types of vessels, are not adhering to the guidelines. From 2006 through 2010, there were between 1,085 (2007) and 2,527 (2009) incidents per year of vessels not following the guidelines reported during the time the observers were present. Soundwatch effort (estimated observation time) has fluctuated in recent years and trends in incident data can be difficult to interpret. There was an increasing trend in the number of incidents from 1998 to 2006, which is not based only on increasing hours of observation time (Industrial Economics, Incorporated 2010). An average of 1.2 incidents was observed per hour in 2003, while an average of 6.02 incidents were observed per hour in 2009.

As in the past several years, the most common Soundwatch observed vessel incident categories in 2010 were:

(1) Vessels parking in the path within 100-400 yards (365.8 m) of whales (Parked in path) at 23 percent of all incidents,

(2) Vessels motoring inshore of whales (Inshore of whales) at 17 percent,

(3) Vessels motoring within 100 yards (91.4 m) of whales (Under power within 100 yards (91.4 m) of whales) at 12 percent, and

(4) Vessels motoring fast (greater than 7 knots) within 400 yards (365.8 m) of whales (fast within1/4mile of whales) at 13 percent of all incidents.

In 2009 there were 2,527 incidents; the majority of these were committed by private boaters (72 percent) and Canadian commercial operators (8 percent). Of the 1,067 incidents in 2010, the majority were committed by private boaters (64 percent) and Canadian commercial operators (10 percent). The most common incidents also reflect this pattern and are most often committed by private boaters and Canadian commercial whale watch vessels.

In both 2009 and 2010, 4 percent of incidents observed were committed by kayaks. Of the 1,067 incidents in 2010, 41 incidents (22 commercial and 19 private kayakers) specific to kayaks were observed, including parking in the path (20 percent of kayak incidents in 2010). Soundwatch has reported that they likely underestimate kayak incidents because the Soundwatch observation vessel remains outside of the current voluntary no-go zone where considerable kayak activity takes place (Dismukes 2010). In 2010, Soundwatch collected new information regarding kayaks from land-based observation points. They observed over 2,100 kayaks with the whales from June to September along the west side of San Juan Island with up to 41 kayaks with the whales at one time. Of the kayaks observed with whales, 74 percent were part of commercial kayaking groups (Koski 2010b). Observers reported a total of 594 incidents of kayakers not following guidelines including 171 incidents of kayaks within 100 yards (91.4 m) of the whales and 88 incidents of kayaks parked within the path of the whales. In most cases when the kayakers made an effort to follow the guidelines they were able to comply with the 100 yard and park in the path guidelines (Koski 2010b).

In addition to monitoring, the Soundwatch program includes an education component, providing information on the viewing guidelines to boaters that are approaching areas with whales. Despite the regulations, guidelines and outreach efforts, interactions between vessels and killer whales continue to occur in the waters of Puget Sound and the Georgia Basin. Advertisements on the Internet and in local media in the Pacific Northwestpromote activities that appear inconsistent with what is recommended in the Be Whale Wise guidelines. NMFS has received letters from the Marine Mammal Commission, members of the scientific research community, environmental groups, and members of the general public expressing the view that some types of interactions with killer whales have the potential to harass and/or disturb the animals by causing injury or disruption of normal behavior patterns. Soundwatch reports high numbers of incidents when vessels are not following the guidelines to avoid harassment (Koski 2004, 2006, 2007, 2008, 2009, 2010a, 2010b). Violations of current ESA and MMPA take prohibitions are routinely reported to NOAA's Office for Law Enforcement; however, the current prohibitions are difficult to enforce. The current prohibition against harassment may require demonstration of changes in the whales' behavior or an injury caused by a specific action which often includes expert testimony regarding behavioral response. NMFS has also received inquiries from members of the public and commercial tour operators requesting clarification of NMFS' policy on what activities constitute harassment.

In 2002, NMFS published an ANPR requesting comments from the public on what types of regulations and other measures would be appropriate to prevent harassment of marine mammals in the wild caused by human activities directed at the animals (67 FR 4379, January 30, 2002). The 2002 ANPR was national in scope and covered all species of marine mammals under NMFS' jurisdiction (whales, dolphins, porpoises, seals and sea lions), and requested comments on ways to address concerns about the public and commercial operators closely approaching, swimming with, touching or otherwise interacting with marine mammals in the wild. Several potential options were presented for consideration and comment, including: (1) Codifying the current NMFS Regional marine mammal viewing guidelines into regulations; (2) codifying the guidelines into regulations with additional improvements; (3) establishing minimum approach regulations similar to the ones for humpback whales in Hawaii and Alaska and North Atlantic right whales; and (4) restricting activities of concern similar to the MMPA regulation prohibiting the public from feeding or attempting to feed wild marine mammals. The 2002 ANPR specifically mentioned the complaints received from researchers and members of the public concerning close vessel approaches to killer whales in the Northwest. NMFS received over 500 comments on the 2002 ANPR regarding human interactions with wild marine mammals in United States waters and along the nation's coastlines.

NMFS has determined that existing prohibitions, regulations, and guidelines described above do not provide sufficient protection of killer whales from vessel impacts. We considered information developed through internal scoping, public and agency comments on the 2002 nation-wide ANPR, a 2007 killer whale-specific ANPR and the 2009 proposed rule (described below), monitoring reports, and scientific information. Monitoring groups continue to report high numbers of vessels around the whales and high numbers of vessel incidents that may disturb or harm the whales. Vessel effects may limit the ability of the endangered Southern Resident killer whales to recover and may impact other killer whales in inland waters of Washington. We therefore deem it necessary and advisable to adopt regulations to protect killer whales from vessel impacts, which will support recovery of Southern Resident killer whales. NMFS' determination that regulations are needed is described in detail in the Rationale for Regulations section below.

In March 2007, we published an ANPR (72 FR 13464; March 22, 2007) to gather public input on whether and what type of regulation might be necessary to reduce vessel effects on Southern Residents. The ANPR requested comments on a preliminary list of potential regulations including codifying the Be Whale Wise guidelines, establishing a minimum approach rule, prohibiting particular vessel activities of concern, establishing time-area closures, and creating operator permit or certification programs. During the ANPR public comment period, we received a total of 84 comments via letter, e-mail and on the Federal e-rulemaking portal. Comments were submitted by concerned citizens, whale watch operators, research, conservation and education groups, federal, state and local government entities, and various industry associations. The majority of comments explicitly stated that regulations were needed to protect killer whales from vessels. Most other comments generally supported protection of the whales. Six comments explicitly stated that no regulations were needed. There was support for each of the options in the preliminary list of alternatives published in the ANPR, and many comments supported multiple approaches. Some additional alternatives were also suggested. A full summary of the comments and NMFS' responses are contained in the proposed rule.

In July 2009, NMFS proposed regulations that would prohibit motorized, non-motorized, and self-propelled vessels in inland waters of Washington from (1) Causing a vessel to approach within 200 yards (182.9 m) of any killer whale; (2) entering a restricted zone along the west coast of San Juan Island during a specified season, and (3) intercepting the path of any killer whale in inland waters of Washington (74 FR 3764, July 29, 2009). The proposed regulations included exemptions for certain vessels and activities. As described in the proposed rule and draft EA, we based the proposed regulations on the best available data on vessels and whales, and public comments on the ANPR.

NMFS published the proposed rule in theFederal Registerand requested public comment on the proposed regulations, the draft EA and supporting documents, such as the Draft Regulatory Impact Review (IEC 2008). To develop the draft EA, we relied on the public comments on the ANPR, the Recovery Plan, Soundwatch data, and other scientific information to develop a range of alternatives to the regulations, including the alternative of not adopting regulations. We analyzed the environmental effects of these alternative regulations and considered options for mitigating effects. After a preliminary analysis of the alternative regulations, we developed an alternative that combined three separate provisions into a single package—a 200-yard (182.9 m) approach restriction, a no-go zone along the west side of San Juan Island fromMay-September, and a prohibition on parking in the whales' path. We analyzed the effects of that package in the draft EA.

NMFS published proposed regulations to protect killer whales on July 29, 2009, and announced two public meetings. In response to requests, NMFS added a third public meeting (74 FR 47779, September 17, 2009) and extended the comment period to January 15, 2010 (74 FR 53454, October 19, 2009). The public meetings were well attended and over 160 people provided recorded oral comments on the proposed rule. During the publiccomment period, 704 unique written comments were submitted via letter, e-mail and the Federal e-rulemaking portal. Comments were submitted by concerned citizens; whale watch operators and naturalists; research, conservation and education groups; federal, state and local government entities; and various industry and other associations. NMFS posted all written comments received during the comment period on the NMFS Northwest Regional Web page:http://www.nwr.noaa.gov/Marine-Mammals/Whales-Dolphins-Porpoise/Killer-Whales/Recovery-Implement/Orca-Vessel-Regs.cfm.In addition to unique comments, over 2,400 form letters were submitted. There were 15 different form letters with the number of copies for each ranging from four to over 1,500. Additionally, we received five petitions that ranged from 100 to 740 signatures each and totaled over 1,300 names and signatures.

Many of the oral and written comments from individual members of the public were short general statements that: (1) Supported the proposed regulations and killer whale conservation in general, (2) disagreed with the proposed regulations, or (3) disagreed only with the proposed no-go zone. Other individual public comments and comments from organizations and government agencies included substantive information, such as specific suggestions to alter the proposed regulations, new information, or additional alternatives to consider. The Marine Mammal Commission made several recommendations in their comments on the proposed rule that are addressed below in response to Comments 4, 6, 7, 14, 16 and 17. The following is a summary of the comments received on both the proposed rule and the draft EA. The proposed rule included almost all of the information in the draft EA and most commenters directed their comments toward the proposed rule. We have grouped and summarized similar comments and recommendations, and responded to issues that directly relate to this rulemaking. Responses to the comments also include descriptions of changes made to the proposed regulations.

Comment 1:Mandatory regulations versus voluntary guidelines. Several commenters supported adoption of mandatory regulations, while other commenters stated that voluntary guidelines are adequate to protect the whales.

Response:Monitoring of vessel activity around the whales reveals that many vessels violate the current voluntary guidelines, the number of violations appears to be increasing, and one of the most serious violations—parking in the path of the whales—was committed primarily by commercial whale watch operators, with a recent increase in parking in the path by recreational boaters. Approaching within 100 yards (91.4 m) of the whales is primarily committed by recreational boaters. In the EA, we examined the available evidence and concluded that mandatory regulations are likely to reduce the number of incidents of vessels disturbing and potentially harming the whales and that this reduction would improve the whales' chances for recovery. We expect both commercial and recreational whale watchers to increase compliance with mandatory regulations compared to the current voluntary guidelines. Commercial whale watchers, in particular, will be aware of the new regulations and can serve as an example of lawful viewing for other boaters. Accordingly, we are adopting mandatory regulations governing vessel activity around the whales.

Comment 2:Enforce state law and maintain current guidelines. Several commenters suggested the current state law, prohibiting approach within 300 feet, should be enforced to increase compliance and that with the current state law and Be Whale Wise guidelines in place, no additional Federal regulations were necessary. One commenter suggested making it unlawful to fail to disengage the transmission of a vessel when within 300 feet of a Southern Resident killer whale similar to the state law.

Response:A state law requiring vessels to stay 300 feet (100 yards (91.4 m)) from Southern Resident killer whales went into effect in June 2008. The Washington Department of Fish and Wildlife (WDFW) has enforced this law since 2008, issuing several violations and many warnings. While NMFS agrees that enforcement of state law has likely improved conditions for the endangered whales, our analysis revealed that vessels at 100 yards (91.4 m) can have harmful effects on whales (see Comment 3: Approach regulation). This final regulation prohibits approaches closer than 200 yards (182.9 m), providing greater protection than the state's 100-yard (91.4 m) law. WDFW supported the 200-yard (182.9 m) approach rule in its comments on NMFS's proposed regulations. NMFS has not included a requirement to disengage the transmission of the vessel when within a certain distance of the whales. The Be Whale Wise guidelines include a recommendation to place engines in neutral and allow whales to pass if your vessel in not in compliance with the 100-yard (91.4 m) approach guideline. NMFS will continue to work with the Be Whale Wise partners to discuss maintaining this recommendation in the guidelines and evaluate the effectiveness of the final regulations to determine if any modifications are needed.

Comment 3:Approach regulation. Some commenters supported an approach limit of 100 yards (91.4 m) (current guideline and state law), and others suggested that an approach limit of 150, 200, 200-400, 1,000 yards (137.1, 182.9, 182.9-365.8, 914.4 m) or several miles would better protect the whales. Commenters noted that an approach regulation could limit the potential for vessels to disturb or collide with whales and for vessel noise to mask the whale's auditory signals, interfering with their ability to communicate and forage. Several whale watch operators raised concerns about how viewing from a distance of 200 yards (182.9 m) would impact their businesses. In addition, they provided comments that viewing from 200 yards (182.9 m) would reduce their ability to educate customers and affect the example they set for other boaters.

Response:In the final EA we fully analyzed the effects of both a 100- and 200-yard (182.9 m) approach regulation. Based on the best available information we concluded that a 100-yard (91.4 m) approach regulation is not sufficient to protect the whales. Researchers have documented behavioral disturbance and estimated the considerable potential for masking from vessels at 100 yards (91.4 m) and as far away as 400 yards (365.8 m). Researchers have modeled the potential for vessel noise to mask the whales' auditory signals and concluded that at 100 yards (91.4 m) there is likely to be up to 100 percent masking, while at 400 yards (365.8 m) the masking has substantially decreased. Even at 200 yards (182.9 m) the models show auditory masking of 75 to 95 percent. We expect the 200-yard (182.9 m) approach limit in the final regulation to significantly reduce the risk of vessel strikes, the degree of behavioral disruption, and the amount of noise that masks echolocation and communication, compared to a 100-yard (91.4 m) approach regulation. An approach regulation greater than 200 yards (182.9 m) would reduce vessel effects even more, but could diminish both the experience of whale watching and opportunities to participate in whale watching. We recognize that whale watching educates the public about whales and fosters stewardship. While it is difficult to quantify theconservation benefits of public education, the Recovery Plan for Southern Resident Killer Whales identifies education and outreach actions as an essential part of the overall conservation program for the whales (NMFS 2008). We believe that a 200-yard (182.9 m) limit strikes an appropriate balance between the need to reduce vessel interactions with Southern Residents and the public interest in whale watching and observation.

Many whale watch operators expressed concern that their business will decrease if they are required to stay 200 yards (182.9 m) away from whales. Several operators conducted informal surveys of their customers to support their assertion that a 200-yard (182.9 m) approach regulation would diminish the experience and make customers less likely to go on whale watching tours. The best available information, however, supports our conclusion that a 200-yard (182.9 m) approach regulation is unlikely to affect the numbers of people who go on whale watching tours or the price they are willing to pay for the experience (see Comment 11: Economic Analysis).

First, observational data from third-party observers reveals that many operators already regularly view whales from 200 yards (182.9 m) or greater. In 2007-2008 a new research program collected detailed information on the distance of vessels from the whales using an integrated range finder, GPS and compass. This study measured the distance between all vessels and the nearest whale and reported that for all vessels within 400 yards (365.8 m) of the whale (likely engaged in whale watching), 74 percent were greater than 200 yards (182.9 m) from the whales. For all vessels within 800 yards (likely includes both whale oriented and transiting vessels), 88 percent of vessels were greater than 200 yards (182.9 m) from the whales (Giles and Cendak 2010).

In addition, the EA accompanying the final rule describes peer-reviewed studies of customer attitudes that identify the features of the whale watching experience that are most valuable to customers. Several studies focused on killer whales in the Pacific Northwest have assessed the value that whale watching participants have for wildlife viewing and provide data on the factors that lead to an enjoyable or memorable whale watching trip, and how satisfied participants are with various aspects of their trip (Dufus and Deardon 1993; Andersen 2004; Andersen and Miller 2006; Malcolm 2004). Survey results of whale watch participants indicate that proximity to the whales is not the most important part of the whale watchers' experience and that seeing whales and whale behavior was much more important (Andersen 2004; Malcolm 2004). In addition, Malcolm (2004) found participants were most satisfied with the respect their vessels gave the whales. The number of whales, whale behavior, and learning also received higher satisfaction than the distance from which whales were observed. The participants also strongly agreed with statements related to protection of the whales. Economic research also indicates that the general public places a high value on the continued existence of species such as the Southern Residents, such that actions necessary for the species' recovery have broad and lasting economic benefits. The Endangered Species Act protects species that are in danger of or threatened with extinction and states that “these species are of esthetic, ecological, educational, historical, recreational and scientific value to the Nation and its people.” Independent research also demonstrates the value that the public places on protection and recovery of endangered species including marine mammals (Loomis and Larson 1994).

While many whale watch operators referenced informal surveys of their customers, these surveys were not scientifically designed and there was no control in their administration. In addition to the evidence described above, we received comments from the public that support the conclusion that a 200-yard (182.9 m) approach regulation will not reduce the public education value of whale watching. These comments highlight the value and effectiveness of educational programs that take place at great distances from the whales, even off the water away from whales, such as in classroom programs.

For the reasons described above and in contrast to the public comments submitted by the commercial whale watching industry, we do not anticipate a reduction in the willingness of customers to participate in commercial whale watch trips or the ability of the whale watching industry to provide an educational and meaningful experience for their customers viewing whales at a distance of 200 yards (182.9 m). In adopting a 200-yard (182.9 m) approach regulation, we evaluated all of the available information on the potential costs to whale watch business. In addition, we balanced the competing conservation benefits to killer whales of reduced vessel interference against continued public education through on-water whale watching opportunities. We consider the viability of the whale watch business to be an integral part of public education. We will continue to study the impact of both motorized and non-motorized vehicle distance limits on whale behavior, and the impact of the newly established regulations on the viability of the whale watch business. NMFS will conduct this analysis alongside the additional consideration of a no-go area discussed in more detail below. If subsequent analysis suggests either a disproportionate impact on segments of the business, or that certain kinds of whale watching, such as the non-motorized business, has less of an effect on whale behavior, we will consider modifying or relaxing restrictions. We will conduct such analysis as the new rulemaking requirements are being implemented over the next two whale watching seasons.

Comment 4:No-go zone. There were a large number of oral and written comments from the public, recreational fishing community, whale watch operators and kayakers in opposition to the proposed no-go zone. Some reasons expressed for opposition to the no-go zone included concerns about setting a precedent for closing additional areas to fishing, impacts to commercial and recreational fishing, elimination of kayaking opportunities, and safety concerns. A number of comments suggested creation of a go-slow zone in the place of a proposed no-go zone. We also received comments supporting the proposed seasonal no-go zone (May-September), as well as suggestions to create a larger no-go zone along the west side of San Juan Island, to include other shoreline areas, and to identify the no-go zone based on feeding “hot spots.”

Additional comments on the proposed no-go zone included support for more or fewer exceptions. Several commenters opposed the proposed exception for treaty fishing. Suggestions for additional exceptions were for recreational and commercial fishing, and a corridor near shore in the zone to allow for kayakers, and property owners using the zone for recreational purposes.

Both oral and written commenters expressed concern that NMFS underestimated the economic impacts in the assessment of the proposed no-go zone. One specific concern was that the economic analysis did not adequately address impacts to the recreational and commercial fishing communities and impacts would be greater that what was considered in the EA.

Several commenters suggested creating a public process to receive additional feedback on the concept ofthe no-go zone and engage the community in developing an appropriate protected area. Others commented that NMFS should select the site based on the best available science and should consider use of areas by the three separate pods of Southern Resident killer whales.

We received several comments specific to the status of the boat launch at the San Juan County Park (within the proposed no-go zone) as a resource supported by grants from the Washington Recreation and Conservation Office and whether it would be “converted” to uses other than those for which it was funded if the no-go zone was implemented.

Response:Public comments on the no-go zone raised several suggested alternatives that we had not fully analyzed in the draft EA. In addition, we recognize that to be effective, regulations must be understood by the public and have a degree of public acceptance. Because of the many alternatives suggested by the public, and because of the degree of public opposition, we have decided to gather additional information and conduct further analysis and public outreach on the concept of a no-go zone. Therefore, the final rule does not adopt a no-go zone. We will pursue this additional work expeditiously because the best available information indicates there would be a significant conservation benefit to the whales if they were free of all vessel disturbance in their core foraging area.

Comment 5:Park in the path. Some commenters supported adoption of a regulation that all vessels must keep clear of the whales' path. Others commented that a prohibition on parking in the path of the whales would be difficult to enforce and raised questions about situations where whales approach vessels. Commenters also suggested that a single approach distance would be easier for boaters to understand compared to a combination of a 200 yard approach distance and a parking in the path prohibition out to 400 yards.

Response:The risks of both vessel strikes and acoustic masking are both most severe when vessels are directly in front of the whales. In addition researchers have reported behavioral responses from vessels out to 400 yards (365.8 m) and beyond and have expressed concern about impacts to important behaviors, such as prey sharing and nursing that occur as the whales move forward. The final regulations include a prohibition on parking in the path because it provides the best management tool for reducing these risks. Increasing the overall approach distance to mitigate for the specific impacts that can occur from vessels in the whales' path (i.e.,a 300 or 400 yard (274.3 or 365.8 m) approach rule) would increase the viewing distance for all whale watchers and could impact the experience of whale watchers and potentially the whale watch businesses (see Comment 3: Approach Regulation). NMFS believes that a 200 yard approach distance in combination with a prohibition on parking in the path of the whales within 400 yards (365.8 m) provides for meaningful and economically viable whale watching and provides additional protection from vessels out in front of the whales. We acknowledge that enforcement of the prohibition on parking in the path of the whales will be challenging and recognize that whales can be unpredictable and can approach vessels unexpectedly. A regulation prohibiting parking in the path of killer whales will be clear to whale watch operators and is consistent with the current guidelines. These operators would likely know about such a regulation and would have some experience in judging the travel path of the whales and estimating a 400 yard (365.8 m) distance. Under certain conditions, however, whale movements can be unpredictable (i.e.,foraging whale pod spread out over a large area) even for experienced whale watchers. The prohibition on parking in the path is intended to address specific situations observed by monitoring groups where operators repeatedly position themselves to intercept the whales and do not get out of the way, rather than unexpected situations where whales are moving erratically and boaters find themselves in the path unexpectedly.

Comment 6:Speed restriction. There were comments in support of codifying the current guideline, which suggests a speed of less than 7 knots when within 400 yards (365.8 m) of the nearest whale. There was also support for go-slow zones in combination with or instead of the proposed no-go zone.

Response:The draft EA concluded that risks of vessel strikes and acoustic masking would be reduced if vessels traveled at a slow speed within 400 yards (365.8 m) of the whales, consistent with the current guidelines. We have not included such a provision in the final regulation because it would be difficult to enforce. We will continue to work with partners on the Be Whale Wise campaign to promote a speed guideline and encourage voluntary compliance to reduce impacts from fast moving vessels in close proximity to the whales. We will also consider go-slow zones when we further evaluate a no-go zone as described above under Comment 4: No-go zone.

Comment 7:Other suggested alternatives. Similar to comments we received in response to the ANPR, comments on the proposed rule included a variety of alternatives to the proposed regulations and the alternatives analyzed in the EA. The suggested alternatives included: Permit programs, stand-by zones, time limits for whale watching, time off from whale watching (days of the week or hours of the day), and a prohibition on whale watching during unsafe weather conditions. Comments suggesting variations on the alternatives fully analyzed have been addressed in Comments 3 through 6.

Response:Some of the alternatives suggested during the public comment period on the proposed rule were similar to alternatives suggested in response to the ANPR and these were considered, but not fully analyzed in the draft EA. The comments on stand-by zones and prohibiting whale watching under certain weather conditions were two new suggestions which were not included in the draft EA. The two new alternatives have been included in the alternatives considered but not analyzed in detail in the final EA. There were several reasons why we did not fully analyze or further consider a number of the alternatives suggested in public comments, including difficulties in enforcing them, changes to infrastructure needed to implement them, or a lack of sufficient science to support them. Alternatives considered but not analyzed in detail in the final EA include: (1) Permit or certification program. A permit or certification program, including stand-by zones, was not fully analyzed because it would require a large infrastructure to administer, monitor and enforce. There would also be equity issues in determining who is permitted or certified and who is not. (2) Moratorium on vessel-based whale watching. A moratorium on all vessel-based whale watching, or protected areas along all shorelines, would be challenging to enforce and are not supported by available scientific information. Both commercial and recreational vessels engage in a variety of wildlife and scenic viewing and other activities on the water and it would be difficult to determine at what point they were engaged in prohibited whale watching. (3) Shipping lane or vessel noise regulations. Regulatory options, such as rerouting shipping lanes or imposing noise level standards would have largeeconomic impacts and unnecessarily restrict some types of vessels rarely in close proximity to the whales. (4) Time limits. It would be difficult to determine when vessels were engaged in whale watching to enforce limits on viewing time, such as the 30 minute limit suggested in the Be Whale Wise guidelines or a time of day restriction on whale watching. (5) Aircraft regulations. Aircraft regulations are beyond the scope of minimizing impacts from vessels as identified in the EA. (6) No whale watching during poor weather conditions. It would be difficult to educate recreational boaters regarding specific weather conditions and when they could or could not watch whales and what vessel activities constitute “whale watching.” There is currently no infrastructure to monitor weather conditions with respect to whale watching and to broadcast the information to alert boaters that particular weather conditions in a certain area trigger a prohibition on whale watching.

Comment 8:Scope and Applicability. NMFS received a variety of comments on the scope and applicability of the regulations including the geographic area, the species covered by the regulation and the types of vessels subject to the regulations. Several commenters suggested applying the proposed regulations throughout the range of the Southern Resident killer whales, rather than limiting the scope to inland waters of Washington. Other comments supported regulations that would apply to other species of whales and marine mammals in addition to killer whales. We received many comments on the types of vessels to which the regulations should apply. Commenters suggested that the regulations should only apply to whale watching vessels and that the regulations should not apply to kayaks. Commenters also identified additional exceptions for certain vessels and these are addressed below under Comment 9: Exceptions.

Response:Establishing regulations in coastal waters is an alternative that was considered, but not fully analyzed in the final EA. Most whale watching occurs in inland waters of Washington, with whale watching vessels originating from nearby ports in the United States and Canada. The presence of Southern Residents and other killer whales in inland waters is predictable and reliable, which is the basis for the success of the local commercial whale watch industry. The presence of the whales and proximity of the whale watching industry in inland waters of Washington concentrates whale watch activity in particular areas. Monitoring groups report a high number of incidents of vessels not following the current viewing guidelines in these waters, particularly along the west side of San Juan Island. There are no monitoring groups observing whale watching activities with killer whales in coastal waters, nor does there appear to be extensive whale watching activity in coastal waters, as we have limited sightings of the whales along the coast, and their presence is not reliable enough to support an active killer whale watching industry. If new information in the future indicates that whale watching poses a threat to the whales in coastal waters, we will consider the need for additional protections.

The final vessel regulation applies to all killer whales. It would be difficult for boaters, especially recreational boaters without expertise and experience with killer whales, to identify Southern Residents or even to identify killer whales to ecotype (resident, transient, offshore). Requiring boaters to know which killer whales they are observing is not feasible. In addition, providing protection to all killer whales in inland waters of Washington is appropriate under the MMPA. Including other whale or marine mammal species is outside the scope of this regulation, which is focused on protecting killer whales and, in particular, supporting recovery of endangered Southern Resident killer whales. Wildlife viewing in inland waters of Washington targets Southern Resident killer whales and while other marine mammal species are the subject of opportunistic viewing, particularly when killer whales are not present, vessel impacts have not been identified as a major threat for other marine mammals in inland waters of Washington. While the regulations do not apply to other marine species, we anticipate that other species may benefit as boaters aware of the regulations may be more likely to know about their potential impacts and keep their distance from all wildlife.

The regulations are designed to reduce the impact from vessels including the risk of vessel strikes, behavioral disturbance, and acoustic masking. Available data on vessel activities indicates that private and commercial whale watch vessels are most often in close proximity to the whales, and that other vessels such as government vessels, commercial and tribal fishing boats, cargo ships, tankers, tug boats, and ferries represent a small proportion (typically 5-7 percent in most years) of the vessels that are within one-quarter mile of the whales. Although not the primary focus of the regulations, vessels conducting activities other than whale watching (i.e.,transport, fishing, etc.) can impact the whales and are also subject to the regulations with some exceptions (i.e.,shipping lanes, safety). Because these vessels do not target the whales and are not often in close proximity, NMFS expects the impacts from adjusting course to avoid getting within 200 yards (182.9 m) of the whales or to stay out of their path will be minimal. We have not included exemptions for Washington State Ferries or vessels associated with oil spill preparedness or training based on the expectation that the vessels will rarely have to adjust their course to comply with the regulations and that the adjustments will be relatively easy to achieve, short-term and minimal. For example, Washington State Ferries already adhere to the 100-yard (91.4 m) guideline and should similarly be able to adhere to a 200-yard (182.9 m) regulation.

Several commenters stated that kayaks do not disturb whales and should be exempt from the regulations. While kayaks are small and quiet, they have the potential to disturb whales as obstacles on the surface. In both 2009 and 2010, 4 percent of incidents observed were committed by kayaks. Of the 1,067 incidents in 2010, 41 incidents (22 commercial and 19 private kayakers) specific to kayaks were observed including parking in the path (20 percent of kayak incidents in 2010). Soundwatch has reported that they likely underestimate kayak incidents because the Soundwatch observation vessel remains outside of the current voluntary no-go zone where considerable kayak activity takes place (Dismukes 2010). New information collected and analyzed in 2010 provides a better assessment of the potential for kayak disturbance and the cumulative effects of large numbers of kayaks in the vicinity of the whales.

For the summer of 2010, Soundwatch's Kayak Education and Leadership Program (KELP), San Juan County Parks, and the San Juan Island Kayak Association worked together to update and refine a Kayaker Code of Conduct as part of KELP. In 2010, the San Juan County Park implemented a required launch permit for boaters using the park boat launch. Before boaters could obtain a permit, they had to attend a required Code of Conduct Training conducted by KELP educators. Commercial operators were required to have all their guides trained by KELP educators and have their guests sign statements acknowledging that they had been trained on the Code of Conduct bytheir guides. The code of conduct includes information about the Washington State law prohibiting approach within 100 yards (91.4 m) of Southern Resident killer whales, the Be Whale Wise guidelines, and additional guidelines such as staying close together (rafting) when whales approach, avoiding stopping at headlands to remain out of the whales path, stopping paddling if whales are within 100 yards (91.4 m) (91.4 meters), and suggestions for assessing their position and remaining outside of the path of the whales by moving offshore or inshore.

In addition to providing the guidelines and training for kayakers through the KELP education program, Soundwatch also monitored kayak activity and compliance of kayakers with the recommendations in the code of conduct to augment the Soundwatch vessel monitoring program. From June through September 2010, 594 total incidents were observed (66 percent commercial and 28 percent private) when kayakers did not follow all guidelines, with 171 incidents when kayaks were within 100 yards (91.4 m) of the whales. The most common incidents were kayaks not rafted, parked on headland or within kelp bed, parked in the path of whales and stopped within 100 yards (91.4 m) of whales (Koski 2010b).

Williamset al.(2010) analyzed impacts of kayaks on Northern Resident killer whales and reported that kayaks can have a significant impact on killer whale behavior. Killer whales exhibited increased probability of traveling behavior, which indicates an avoidance tactic, and decreased feeding activities when kayaks were present (Williamset al.2010). For additional information on the scientific assessment of kayak impacts on killer whales see Comment 10: Scientific basis for regulations. Based on the best available information, the final regulations will apply to all vessels including kayaks to reduce impacts to the whales.

Comment 9:Exceptions. Commenters provided a range of suggestions for additional exceptions (i.e.,kayaks and sail boats, Washington State Ferries, all vessels except whale watching) and expressed disagreement with some of the exceptions in the proposed rule (vessels actively engaged in fishing). Almost all of these comments were specific to the proposed no-go zone. An exception for kayaks to all regulations is discussed under Comment 8: Scope and Applicability. Several commenters suggested wording changes regarding the exception for ships in the shipping lanes and their support vessels, and the exception for vessels actively engaged in fishing activities, and other suggested exempting ferries and vessel engaged in oil spill preparedness and training.

Response:Almost all of the suggestions for additional exceptions or fewer exceptions to the rule were specific to the no-go zone. While the no-go zone is not part of this final rule, NMFS will consider the information on exceptions and other aspects of a no-go zone (see Comment 4: No-go zone) and respond at a later date. NMFS has made changes to the description of the exception for vessels in the established shipping lanes, known as the Traffic Separation Scheme, to clarify when and how it applies to certain vessels. NMFS has also amended the language regarding exceptions for vessels actively engaged in fishing to include transfer of catch, however, vessels transiting to or from or scouting fishing areas are not exempt from the regulations. We expect impacts to these activities associated with fishing to occur in close proximity to whales only rarely and expect any impacts from changing course to maintain 200 yards (182.9 m) or to stay out of the whales' path to be minimal (IEC 2010).

Ferries and vessels associated with oil spill preparedness and training do not target the whales and are not often in close proximity, therefore, NMFS expects the impacts from adjusting course to avoid getting within 200 yards (182.9 m) of the whales and to stay out of their path on rare occasions will be minimal. We have not included exemptions for Washington State Ferries or vessels associated with oil spill preparedness or training based on the expectation that these vessels will rarely have to adjust their course to comply with the regulations and that the adjustments will be relatively easy to achieve, minimal and short-term. For example, Washington State Ferries already adhere to the 100-yard (91.4 m) guideline and should similarly be able to adhere to a 200-yard (182.9 m) regulation. Support vessels associated with booming activities required for fuel transfer or emergency pollution response would be exempt from the regulations based on the exemption for safe operation; we amended the safety exception to include these vessels.

Comment 10:Scientific basis for regulations. Commenters raised questions about the scientific information used to support the vessel regulations. Scientific information on the vessel impacts to whales was called biased, inconclusive, questionable, or wrong. Commenters placed a higher value on their personal observations than on the results from published studies and asserted that they have not seen the whales changing their behavior in response to vessels. Commenters raised concerns that scientists conducting scientific studies on killer whale were biased against the whale watch industry. Some commenters highlighted that results were not conclusive and challenged the interpretation of specific research results, questioning that increased energy expenditure form avoiding vessels or engaging in high energy surface active behaviors, like breaching and tail slapping, would result in a negative impact on the whales. Other commenters questioned the use of models to estimate the potential impact of vessel sound on the whales' ability to use echolocation to find prey in their habitat. Several commenters questioned the science used to demonstrate the potential for kayaks to impact killer whales primarily because it referred to studies on species other than killer whales in other geographic locations.

Response:NMFS relied on the best available data to develop the proposed and final regulations. The majority of the information came from peer reviewed scientific publications. To a lesser extent, unpublished data, personal accounts and other anecdotal information also informed development of the regulations. We gave greater weight to sound peer reviewed studies published in scientific journals than to personal observation and interpretation. These scientific studies use established scientific methods, test hypotheses, employ statistical analysis, and have been peer reviewed and published in scientific journals. These steps in the scientific process reduce the potential for bias in results. We reviewed all of the best available information from multiple independent scientists which also limits the concerns about potential bias related to one individual researcher.

Several independent scientists have reported behavioral changes in whale swimming patterns, changes in respiratory patterns, reduced time spent foraging/feeding, and increased surface active behaviors in the presence of vessels. These studies provide multiple lines of evidence regarding the nature and degree of vessel impacts on the behavior of killer whales. The data from these studies have been rigorously analyzed and the results are statistically significant. Some of the reported behavioral changes may not be obvious to casual observers.

We acknowledge that there is some uncertainty involved in interpretation of the results in the peer reviewed published papers. While we evaluated the quality, applicability anduncertainty in the scientific information, we also relied on a conservative approach in weighing the severity and likelihood of impacts from vessels in light of the whales' status as an endangered species. The Norenet al.(2009) study reported increased energetically expensive surface active behaviors in the presence of vessels, and we considered the uncertainty regarding the conclusions. For example, the function of surface active behaviors is not known for certain. Norenet al.(2009) suggest these behaviors may serve a role in communication to promote group coordination, while several commenters speculated that it was play or that the whales enjoyed showing off for whale watch boats. Norenet al.(2009) also acknowledged uncertainty based on the limits of the study to provide details on all of the variables that determine whether vessel presence elicits a response in the whales. Even with the uncertainty about the function of the behaviors and some of the conclusions, we did consider the increased energy expenditure as an important result. We were conservative in assuming that increased energy expenditure likely has a negative impact on the whales, particularly in light of the concerns regarding reduced prey for the whales and other studies that found short-term behavioral responses can have long-term consequences for individuals and populations (Lusseau and Bejder 2007).

With field studies of wild animals there will always be some uncertainties because it is not possible to control for all of the variables. In addition, there are some hypotheses that cannot be tested with wild animals in the field. We routinely use models with inherent assumptions to help fill these data gaps and inform our decisions. For example, there is no direct data to measure a reduction in the efficiency of echolocation in the presence of vessel sound. Instead, we relied on a model created to estimate the vessel sound under varying conditions and calculate a reduction in echolocation efficiency. This model is based on data collected on the whales' hearing capabilities, sound recordings of vessels, sound propagation models, and some assumptions about the whales' ability to detect a salmon in the water column. We believe these assumptions are justified by the available information.

In the case of assessing the impact of kayaks on killer whales, we relied on studies done on similar species in other locations and research results that indicated trends, but were not conclusive. Several commenters questioned our reliance on studies of the effects of kayaks on dolphins to support a conclusion that kayaks have the potential to disturb killer whales. Although we believe the dolphin studies give insight into effects on killer whales (the largest member of the dolphin family), in response to these comments, we secured additional analysis of available data on Northern Resident killer whales. Williamset al.(2010) assessed the effects of kayak presence on Northern Resident killer whales and reported that kayaks can have a significant impact on killer whale behavior. In previous studies, Williamset al.(2006) reported changes to killer whale behavior from boat presence, pooling kayaks and motorized vessels together. In their recent study, the presence of both types of vessels was analyzed separately for data from 1995-2004. In the presence of only kayaks, the probability that the whales will shift to travel behavior from other behavior states (including feeding) significantly increased compared to situations with no vessels present, which indicates an avoidance tactic. As a result, the whales spent significantly more time traveling when in the presence of kayaks than they did under no-boat conditions (11 percent increase in time spent traveling). Consistent with previous studies, killer whales significantly reduced overall time spent feeding in the presence of kayaks and powerboats compared to no-boat conditions (30 percent decrease in time spent feeding). With respect to both kayaks and motorized vessels, the duration of feeding decreased and the overall proportion of time spent feeding decreased when vessels were present, regardless of the type of vessel. One model suggested that the effect of kayaks on feeding activity was perhaps less pronounced than the effect of powerboats on feeding activity. The types of effects vessels have on foraging activities seem to be similar whether the boats involved are kayaks or other types of vessels, but the whales may use different avoidance tactics to deal with the two types of vessels (Williamset al.2010).

Comment 11:Economic analysis. Comments from individuals, commercial whale watch and other industry associations focused on the economic analysis and disagreed with some conclusions in the EA. Commenters believed that NMFS did not adequately evaluate potential economic impacts from new vessel regulations to whale watching businesses, kayak companies, recreational and commercial fishing communities, and the local economy in the San Juan Islands. In addition, several people providing oral comments were concerned that the economic analysis was conducted by a contractor outside of the Puget Sound area. Other commenters suggested that the proposed regulations would have a positive economic impact by protecting the whales, which draw large numbers of people to the area.

Response:In comments on the ANPR and on the proposed rule, whale watch operators expressed concerns regarding the economic impacts to their business from reduced participation in commercial whale watch trips conducted at 200 yards (182.9 m) from the whales. In the Pacific Whale Watch Association comments on the proposed rule, they suggested that at least one company would go out of business and estimated a 30 percent reduction in the number of companies participating in the industry over three years and a drop in revenue for the remaining 70 percent. No commenters provided data to support this assertion. The comments summarized information from informal surveys of customers indicating that they would not book a trip if they would be watching from 200 yards (182.9 m). The whale watch association also asserted that one of their most frequently asked questions is “How close can we get?” and 5 percent of bookings are lost when they answer “100 yards (91.4 m).” In the comments, the whale watch association acknowledged that their informal communications with customers were admittedly not “scientifically accurate surveys”. The information from the informal customer surveys also contradicts information from published, peer reviewed, scientifically conducted surveys about the important features of trips for customers. Our analysis of the likely impacts to the whale watch industry relied on the published, peer reviewed, and scientifically conducted surveys using accepted statistical methods rather than the anecdotal information provided by the industry. As part of implementation of new regulations, NMFS will monitor to evaluate effectiveness of the regulations, as well as identify any unanticipated impacts in order to inform adaptive changes to the regulation.

To analyze economic impacts of alternative regulations, NMFS contracted with Industrial Economics, Incorporated (IEC), which has its headquarters in Massachusetts. IEC also has employees located in the Pacific Northwest. IEC has extensive expertise conducting economic analyses regarding actions taking place in Washington State waters, including Puget Sound. IEC hasgathered data and worked on multiple projects in the area, including salmon and killer whale critical habitat designations. In response to concerns raised in public comments about IEC's lack of local knowledge, IEC identified local economics experts from the University of Washington to review the draft economics analysis, help identify additional data, and contribute to the final economic analysis. The local economics experts reviewed the data sources, analysis methods, and assumptions about the study area. They supported the data and methods used. The local experts provided suggestions for clarifications of some assumptions, more detailed descriptions of data sources and methods, and inclusion of additional information on the positive impacts of protecting the whales (i.e.,existence values.) They did not identify any additional data sources to inform the analysis. IEC incorporated the results of this additional local review into the final economic analysis.

The economic analysis considers the potential that the Southern Resident killer whales could go extinct without regulatory protection and, therefore, reduce the value of the whale watching industry and contributions to the local economy. The economic analysis also indicates that the continued existence of rare species, including marine mammals, has a broad-based economic benefit separate from the viability of the whale-watching industry. The Endangered Species Act protects species that are in danger of or threatened with extinction and states that “these species are of esthetic, ecological, educational, historical, recreational and scientific value to the Nation and its people.” Independent research also demonstrates the value that the public places on protection and recovery of endangered species including marine mammals (Loomis and Larson 1994).

Comment 12:Legal issues. Several comments included concerns regarding the legality of NMFS regulating vessel traffic in the transboundary area of Haro Strait with respect to the Treaty of 1846 between the United States and the United Kingdom [Canada] regarding maritime boundaries and rights of navigation. There were also comments suggesting that all whale watching activity is illegal because it involves “pursuit,” which is prohibited under the Endangered Species Act. Some comments also questioned our compliance with Executive Order 12866 and the Regulatory Flexibility Act.

Response:Neither the proposed nor the final regulations violate the 1846 Treaty. NMFS has the authority to establish vessel regulations (including the proposed no-go zone) to protect killer whales from vessels in United States waters and related activities under various domestic laws including the Endangered Species Act (ESA) and the Marine Mammal Protection Act (MMPA). Both the proposed and the final vessel regulations are reasonable and consistent with a coastal nation's ability to regulate the navigation of vessels in its territorial seas and internal waters under international law.

The ESA prohibits the “take” of endangered species, which it defines to mean “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture or collect, or to attempt to engage in any such conduct.” The statute does not define the term “pursue” nor have we adopted regulations defining pursuit. Under both the ESA and MMPA, there are no exceptions to the take prohibition for whale watching; therefore wildlife viewing must be conducted in a manner that does not cause take. To promote responsible and sustainable marine animal viewing that avoids take, NMFS has worked with a variety of whale watch industries in multiple regions to develop numerous education programs, viewing guidelines and regulations. The agency believes that whale watching enhances marine mammal conservation by increasing education and fostering stewardship. The Recovery Plan for Southern Resident killer whales describes the educational benefits of whale watching and identifies actions such as supporting naturalist trainings (NMFS 2008). This is also the case for other species. The Recovery Plan for North Atlantic Right Whales includes a section on whale watching and includes actions regarding educating vessel operators about regulations and guidelines as well as training whale watch naturalists and including conservation messages to whale watchers (NMFS 2005). For this reason, we have not sought to curtail responsible viewing by applying an expansive interpretation to the prohibition on “pursuit.” For additional information on NMFS' nationwide efforts to promote responsible wildlife viewing, please visithttp://www.nmfs.noaa.gov/pr/education/viewing.htm.

We conducted a Regulatory Impact Review/Regulatory Impact Assessment (RIR/RIA) in accordance with Executive Order 12866 and the Regulatory Flexibility Act. We incorporate this assessment and the Final Regulatory Flexibility Analysis into the final EA as Chapter 6. The RIR/RIA summarizes the costs and benefits of alternative regulations, including the No-action Alternative of not promulgating regulations. The final EA, including RIR/RIA analysis, and separate economic analysis (IEC 2010) contain all the elements required of a RIR/RIA. The RIR/RIA also serves as a basis for our determination on whether the proposed action is a “significant regulatory action” under the criteria provided in Executive Order 12866.

Comment 13:NMFS should address other threats. Many oral and public comments cited the threats of pollution and contamination and insufficient salmon prey for the whales. A small number of comments raised concerns about use of Navy sonar. Some commenters suggested we should focus on these threats rather than vessel regulations, while other commenters supported the regulations and encouraged NMFS to also address the other threats.

Response:Promulgation of vessel regulations to protect Southern Resident killer whales is just one part of a comprehensive recovery program to address all of the major threats to the whales. The Recovery Plan for Southern Resident Killer Whales includes actions to address each of the threats and there are many ongoing efforts in the region to restore depleted salmon populations, clean up the Puget Sound ecosystem, develop a response plan for oil spills, use existing MMPA and ESA mechanisms to address sounds like Navy sonar, conduct education and outreach activities, and implement other actions in the plan (NMFS 2008). For more information on implementation of the recovery plan, please visithttp://www.nwr.noaa.gov/Marine-Mammals/Whales-Dolphins-Porpoise/Killer-Whales/Recovery-Implement/index.cfm.For specific information on salmon recovery, please visithttp://www.salmonrecovery.govand for more information on efforts to address pollution and contaminants, please visithttp://www.psp.wa.gov/.To the extent that actions authorized, funded, or carried out by a Federal agency may affect species listed under the ESA, the agency is required to consult with NMFS pursuant to ESA section 7, 16 U.S.C. 1536, and its implementing regulations.

Comment 14:Education about regulations. A number of commenters suggested that for new regulations to be effective it was essential to have a strong educational component.

Response:We agree that educating the public and industry is essential to promote compliance with any new regulations and achieve a reduction in vessel impacts to the whales. We recognize that adopting regulations that are different from the current voluntaryguidelines and State law may present some challenges. The new regulations, however, are largely extensions or expansions of the existing guidelines and Washington law. Additionally, the current infrastructure includes enforcement, monitoring, and stewardship groups, who will be available to assist with an education campaign to inform boaters about the new regulations and the scientific information on which they are based. We have developed an implementation plan for the new regulations that includes an active education program with our many partners including WDFW, the U.S. Coast Guard, Soundwatch, Straitwatch, and the Department of Fisheries and Oceans Canada. As part of an education program we will continue to work with partners on guidelines for safe operating procedures in the vicinity of whales.

Comment 15:Enforcement. Many commenters stressed the importance of enforcement for any new regulations to be effective. While some comments suggested that enforcing current guidelines and the state law would be sufficient to protect the whales, others supported the proposed regulations if there were sufficient resources to enforce new regulations.

Response:We agree that enforcement is essential to promote compliance with any new regulations and achieve a reduction in vessel impacts to the whales. Vessel operators are more likely to adhere to mandatory specific regulations than to the current voluntary guidelines. This likelihood for any particular rule would be affected by the clarity of the rules, motivations to comply, and the level of monitoring and enforcement. It is reasonable to assume that commercial operators would know about mandatory regulations, for the same reasons that they are familiar with the current specific voluntary guidelines, and would have strong incentives to comply to protect their business reputation. Recreational boaters are also more likely to comply with mandatory regulations, although they may be less likely to know the details of mandatory regulations than are commercial operators. Regulations with specific distances to the whales provide new tools for enforcement, so that cases are more straightforward and based on an objective criteria, like distance, rather than demonstrating changes in the behavior of the whales with respect to a specific action. Distance regulations are in place for other marine mammals and the NOAA Office for Law Enforcement has experience enforcing this type of regulations. In general, promulgation of specific mandatory regulations is likely to increase enforcement capability and compliance, which will result in fewer incidents between vessels and whales than occurs under the current regime. We have developed an implementation plan for the new regulations that includes an active education program with our many partners including WDFW, the U.S. Coast Guard, Soundwatch, Straitwatch, and the Department of Fisheries and Oceans Canada. See above Comment 1: Mandatory regulations versus voluntary guidelines and Comment 2: Enforce state law and maintain current guidelines, for additional information describing the current guidelines and regulations and our determination regarding the need for these new Federal regulations to protect the whales.

Comment 16:Monitoring effectiveness of regulations. Several commenters who supported the vessel regulations suggested that monitoring the effectiveness of regulations would be an important step to assess compliance and the benefit to the whales and identify and needed changes in the future. Several commenters expressed concern about the regulations, but were more supportive if there was a periodic review in place to evaluate the regulations.

Response:We agree that monitoring effectiveness of the regulations is an important part of an adaptive management process to ensure the regulations are effective in protecting the whales and to identify any unforeseen impacts to local communities. The success of a regulatory program to address vessel impacts is vital to recovery of the Southern Resident killer whales. Therefore, we will monitor the effectiveness of the final regulations and consider altering the measures or implementing additional measures if appropriate. We will continue to collect data on vessel activities in the vicinity of the whales to assess the anticipated increase in compliance with mandatory regulations and reduction in impacts to the whales. As described above (see Comment 3: Approach regulation, Comment 4: No-go zone, and Comment 11: Economic analysis) we will also continue to gather information and further consider the proposed no-go zone as an additional measure to protect the whales.

Comment 17:Consistent regulations in the United States and Canada. Several commenters supported consistent regulations in both United States and Canadian waters to assist with educating boaters and provide adequate protection for the whales.

Response:Southern and Northern Resident killer whales are listed as endangered and threatened, respectively, under the Species at Risk Act in Canada. We have coordinated for several years with the Canadian Department of Fisheries and Oceans to develop consistent guidelines for boaters operating in the waters of both countries. We will continue coordinating on guidelines and provide support for any efforts in Canada to also consider 200-yard (182.9 m) approach guidelines or regulations to maintain consistency and provide a benefit to the whales. Even without similar regulations in Canada, this rulemaking will provide substantial benefits to the Southern Residents because the whales spend considerable time in United States waters.

Comment 18:Technical changes. Several commenters including the U.S. Coast Guard suggested technical wording changes to ensure accuracy with other regulations or improve clarity of the rule.

Response:NMFS agreed with a number of the suggestions for small technical changes and made appropriate changes to the final rule and EA to ensure accuracy and improve clarity. In some cases we eliminated wording to simplify the regulations, such as removing the second sentence describing the 200-yard (182.9 m) approach prohibition.

Current efforts to reduce vessel impacts have not been sufficient to address vessel interactions that have the potential to harass and/or disturb killer whales by causing injury or disruption of normal behavior patterns (See Need for New Regulations). These regulatory measures are designed to protect killer whales from vessel impacts and will support recovery of Southern Resident killer whales. We are issuing these regulations pursuant to our rulemaking authority under MMPA section 112(a) (16 U.S.C. 1382(a)), and ESA 11(f) (16 U.S.C. 1540(f)). These final regulations also are consistent with the purpose of the ESA “to provide a program for the conservation of [* * *] endangered species” and “the policy of Congress that all Federal departments and agencies shall seek to conserve endangered species [* * *] and shall utilize their authorities in furtherance of the purposes of [the ESA].” 16 U.S.C. 1531(b), (c).

As part of the rulemaking process, we first published an ANPR and then a proposed rule that included proposedregulations with three elements that would prohibit motorized, non-motorized, and self-propelled vessels in inland waters of Washington from: (1) Causing a vessel to approach within 200 yards (182.9 m) of any killer whale; (2) entering a restricted zone along the west coast of San Juan Island during a specified season, and (3) intercepting the path of any killer whale in inland waters of Washington. Based on public comments we are issuing final regulations with only two of the elements that were in the proposed rule.

Public comments on the no-go zone raised several suggested alternatives that we had not fully analyzed in the draft EA. In addition, we recognize that to be effective, regulations must be understood by the public and have a degree of public acceptance. Because of the many alternatives suggested by the public, and because of the degree of public opposition, we have decided to gather additional information and conduct further analysis and public outreach on the concept of a no-go zone. Therefore, the final rule does not adopt a no-go zone. We will pursue this additional work expeditiously because the best available information indicates there would be a significant conservation benefit to the whales if they were free of all vessel disturbance in their core foraging area.

The following sections pertain to the final regulations prohibiting motorized, non-motorized, and self-propelled vessels in inland waters of Washington from: (1) Causing a vessel to approach, in any manner, within 200 yards (182.9 m) of any killer whale, and (2) intercepting the path of any killer whale in inland waters of Washington. Below we describe the scope and applicability, requirements and rationale for the final regulations.

Application to All Killer Whales:Under the MMPA and ESA the final regulations will apply to all killer whales. Although killer whales are individually identifiable through photo-identification, individual identification requires scientific expertise and resources (i.e.,use of a catalog) and cannot always be done immediately at the time of the sighting. It would be difficult for boaters, especially recreational boaters without expertise and experience with killer whales, to identify the individuals in the ESA-listed Southern Resident DPS or even to identify killer whales to ecotype (resident, transient, offshore). Requiring boaters to know which killer whales they are observing is not feasible. Section 11(f) of the ESA provides NMFS with broad rulemaking authority to enforce the provisions of the ESA. In addition, section 112(a) of the MMPA provides NMFS with broad authority to prescribe regulations that are necessary to carry out the purposes of the statute. Providing protection for all killer whales is a practical consideration because boaters cannot tell different types of killer whales apart and will also reduce the risk of disturbance or injury for all types of killer whales which is consistent with the purpose of the MMPA.

Geographic Area:Regulations will apply to vessels in inland waters of Washington under U. S. jurisdiction. Inland waters include a core summer area for the whales around the San Juan Islands, as well as a fall foraging area in Puget Sound and transit corridor along the Strait of Juan de Fuca. These three areas make up over 2,500 square miles and were designated as critical habitat for Southern Resident killer whales (71 FR 69054; November 29, 2006). These regulations will apply to an area similar to designated critical habitat, including inland waters of the United States east of a line connecting Cape Flattery, Washington (48°23′10″ N./124°43′32″ W.), Tatoosh Island, Washington (48°23′30″ N./124°44′12″ W.), and Bonilla Point, British Columbia (48°35′30″ N./124°43′00″ W.) and south of the U.S./Canada international boundary. The shoreline boundary is the charted mean high water line cutting across the mouths of all rivers and streams.

Vessels Subject to Final Rule:The regulations apply to all motorized and non-motorized vessels in the inland waters of the United States described above. All vessels in U.S. waters, including foreign flag vessels, and persons not citizens of the United States are subject to the jurisdiction of the United States to the extent consistent with recognized principles of international law, including treaties and international agreements to which the United States is signatory. Commercial and recreational whale watch vessels include both motorized and non-motorized vessels (i.e.,kayaks and sail boats), both of which can cause disturbances to whales. While kayaks are small and quiet, they have the potential to disturb whales as obstacles on the surface. Kayaks may startle marine mammals by approaching them without being heard (Mathews 2000). Data indicate that substantial numbers of kayakers failed to follow existing voluntary guidelines, and in a study of sea lions, Mathews (2000) found that kayakers were significantly more likely to approach wildlife closely. Kayakers may approach wildlife more closely because they may be more apt to overestimate distance because of their low aspect on the water, and to assume they are less likely to disturb wildlife than other vessels (Mathews 2000). In studies comparing effects of motorized and non-motorized vessels on dolphins, the type of vessel did not matter as much as the manner in which the boat moved with respect to the dolphins (Lusseau 2003b). Some dolphins' responses to vessels were specific to kayaks or were greater for kayaks than for motorized vessels (Lusseau 2006, Gregory and Rowden 2001, Duran and Valiente 2008). Several studies that have documented changes in behavior of dolphins and killer whales in the presence of vessels include both motorized and non-motorized vessels in their analysis (Lusseau 2003b, Nicholset al.2001, Triteset al.2007, Norenet al.2007, 2009).

In response to public comments regarding our reliance on studies of kayak impacts involving other species, NMFS secured additional analysis of available data on Northern Resident killer whales and behavioral responses to kayaks. Williamset al.(2010) analyzed the effects of kayak presence on Northern Resident killer whales and reported that kayaks can have a significant impact on killer whale behavior. In previous studies, Williamset al.(2006) reported changes to killer whale behavior from boat presence, pooling kayaks and motorized vessels together. In their recent study, the presence of both types of vessels was analyzed separately for data from 1995-2004. In the presence of only kayaks, the probability that the whales will shift to travel behavior from other behavior states (including feeding) significantly increased compared to no-boat conditions, which indicates an avoidance tactic. As a result, the whales spent significantly more time traveling when in the presence of kayaks than they did under no-boat conditions (11 percent increase in time spent traveling). Consistent with previous studies, killer whales significantly reduced overall time spent feeding in the presence of kayaks and powerboats compared to no-boat conditions (30 percent decrease in time spent feeding). With respect to both kayaks and motorized vessels, the duration of feeding decreased and the overall proportion of time spent feeding decreased when vessels were present, regardless of the type of vessel. One model suggested that the effect of kayaks on feeding activity was perhaps less pronounced than the effect ofpowerboats on feeding activity. The types of effects vessels have on foraging activities seem to be similar whether the boats involved are kayaks or other types of vessels, but the whales may use different avoidance tactics to deal with the two types of vessels (Williamset al.2010).

While the specific information on impacts to killer whales from kayaks is preliminary at this time, we have taken a conservative approach in assessing this information in light of the endangered status of the Southern Residents. We have considered the information with respect to cumulative impacts as well as the other threats to killer whale survival and recovery. Even if the effects are small for individual kayakers, there are large numbers of kayakers targeting the whales and the cumulative impacts of both kayaks and other types of vessels are significant. In June to September 2010, Soundwatch monitored zones out to1/2mile from shore and observed over 2,100 kayaks in the monitoring zones with the whales and up to 41 kayaks with the whales at one time. Soundwatch observed 594 incidents of kayakers not following recommended guidelines. The cumulative impact of kayaks and all vessels and their effect on feeding behavior is particularly important because we are concerned about the whales' ability to get sufficient prey to maintain their health. Based on all of the information available and a conservative approach to protect endangered Southern Residents, NMFS' final regulations protect killer whales from both motorized and non-motorized vessels.

Exceptions:Five specific categories of vessels will be exempt from the vessel regulations: (1) Government vessels, (2) cargo vessels transiting in the shipping lanes, (3) research vessels, (4) fishing vessels actively engaged in fishing, and (5) vessels limited in their ability to maneuver safely. These exceptions are based on the likelihood of certain categories of vessels having impacts on the whales and the potential adverse effects involved in regulating certain vessels or activities.

Available data on vessel effects on whales from Soundwatch (Koski 2007, 2008, 2009, 2010a), Bain (2007) and Giles and Cendak (2010) indicate that commercial and recreational whale watch vessels are more likely to affect killer whales. This is because operators of whale watching vessels are focused on the whales, track the whales' movements, spend extended time with the whales, and are therefore most often in close proximity to the whales. Other vessels such as government vessels, commercial and tribal fishing boats, cargo ships, tankers, tug boats, and ferries do not target whales in their normal course of business. Soundwatch (Koski 2007, 2008, 2009, 2010a) and Bain (2007) report that these types of vessels combined comprise only 6 percent or less of vessels within1/2mile of the whales from 2006-2009. In 2010 there was a higher percent of commercial fishing vessels observed within1/2mile of the whales which was likely due to increased fishery openings coinciding with presence of whales (Koski 2010b). In 2007-2008, Giles and Cendak (2010) recorded the distance of vessels from the whales using an integrated GPS, range finder and compass and reported only 21 ferries and 22 shipping vessels out of 11,710 vessels observed within 1,000 yards of the whales (0.4 percent). In addition, these vessels generally move slowly and usually in a predictable straight path, which reduces the risk of strikes to whales. While NMFS recognizes that sound from large vessels has the potential to affect whales even at great distances, the primary concern based on available information is the sound from small, fast moving vessels moving in close proximity to the whales and targeting the whales.

Ferries and vessels associated with oil spill preparedness and training do not target the whales and are not often in close proximity; therefore, NMFS expects the impacts from adjusting course to avoid getting within 200 yards (182.9 m) of the whales and to stay out of their path on rare occasions will be minimal. We have not included exemptions for Washington State Ferries, other publicly operated ferries, or vessels associated with oil spill preparedness or training based on the expectation that these vessels will rarely have to adjust their course to comply with the regulations and that the adjustments will be relatively easy to achieve, minimal and short-term. For example, Washington State Ferries already adhere to the 100-yard (91.4 m) guideline and should similarly be able to adhere to a 200-yard (182.9 m) regulation.

Vessels engaged in scientific research do closely approach killer whales to obtain photographs, collect a variety of samples, and observe behavior. Researchers must obtain permission from NMFS before they may legally closely approach the whales. Before permitting research, NMFS evaluates the potential effects of these activities under both the ESA and MMPA. Expertise of researchers, operating procedures, and permit terms and conditions reduce the potential impacts to whales. In issuing permits, NMFS weighs the benefit of the research to the whales' survival and recovery against the harmful impacts of close approaches.

Regulating some categories of vessels could cause adverse impacts. Government vessels are often critical to safety missions, such as search and rescue operations, enforcement, pollution response and activities critical to national security. The movement of large commercial vessels in U.S. and Canadian waters in the area are managed by the Puget Sound Vessel Traffic Service and the Cooperative Vessel Traffic Service, which are designed to efficiently and safely manage vessel transits in the shared waters of the U.S. and Canada. U.S. regulations require power-driven vessels 40 meters or greater in length, while navigating or towing vessels eight or more meters in length, and vessels certificated to carry 50 or more passengers for hire when engaged in trade to participate in the Vessel Movement Reporting System (VMRS) (Navigation and Navigable Waters, 33 CFR 161). These ships generally follow well-defined navigation lanes established by the International Maritime Organization (IMO), known as Traffic Separation Schemes (TSS) (rules for vessel conduct is established by U.S. Coast Guard Navigation Rule 10). If large ships following traffic lanes or making their way to or from the lanes were required to make sudden or unpredictable movements to avoid close approaches to whales, it may impact the good order and predictability of maritime traffic, as well as adversely affect navigation safety, thus increasing the risk of collision and groundings. For the safety of vessel navigation, large ships are sometimes escorted or assisted by smaller vessels such as tug boats, which sometimes navigate just outside the designated lanes. Sudden or unpredictable movements by these escort vessels, in order to avoid close approaches to whales, could also increase the risk of collisions and pose safety hazards. Support vessels associated with booming activities required for fuel transfer or emergency pollution response would also be exempt from the regulations based on the exemption for safe operation.

Commercial fishing vessels, in which the fish harvested are intended to enter commerce, when actively engaged in fishing are exempt from the new regulatory requirements. If they were required to follow regulations while actively engaged in fishing, it could compromise gear or catch. Also, treaty Indian fishing vessels actively engagedin fishing are exempt from the new regulatory requirements. Exempting treaty Indian fishing vessels is consistent with treaty fishing rights and use of Usual and Accustomed fishing areas. NMFS is also exempting vessels from any regulations if the exemption is required for the safe operation of a vessel to avoid adverse effects to public safety.

Based on these considerations, NMFS' final regulations include several exceptions. The burden would be on the vessel operator to prove the exception applies, and vessel operators would not be exempt from the take prohibitions under the MMPA or ESA. Federal government vessels would not be exempt from consultation requirements under Section 7 of the ESA. The following exceptions apply to all regulations:

(1) The regulations would not apply to Federal Government vessels operating in the course of official duty or to state and local government vessels engaged in official duties involving law enforcement, search and rescue, or public safety.

(2) The regulations would not apply to vessels participating with a Vessel Traffic Service (VTS) and following a Traffic Separation Scheme or complying with a VTS Measure of Direction. This also includes boats escorting vessels in the traffic lanes, such as tug boats.

(3) The regulations would not apply to activities, such as scientific research, authorized through a permit issued by the National Marine Fisheries Service under part 222, subpart C, of this chapter (General Permit Procedures) or through a similar National Marine Fisheries Service authorization.

(4) The regulations would not apply to treaty Indian and commercial fishing vessels lawfully engaged in actively setting, retrieving, or closely tending fishing gear or transferring catch. (Note: The regulations would apply to all fishing vessels, including treaty Indian and non-treaty vessels, transiting to or from fishing areas.)

(5) The regulations would not apply to vessel operations necessary for safety to avoid an imminent and serious threat to a person or vessel, including when necessary for overall safety of navigation, to comply with the Navigation Rules, or in direct support of environmental protection.

Approach Restrictions:The final regulations prohibit vessels from approaching any killer whale in the inland waters of Washington closer than 200 yards (182.9 m). This includes approaching, in any manner, including by interception (i.e.,placing a vessel in the path of an oncoming killer whale, so that the whale surfaces within 200 yards (182.9 m) of the vessel, or positioning a vessel so that wind or currents carry the vessel to within 200 yards (182.9 m) of a whale).

Prohibition against parking in the whales' path:The final regulations require vessels to keep clear of the whales' path within 400 yards (365.8 m) of the whales. Parking in the path includes interception (positioning a vessel so that whales surface within 200 yards (182.9 m) of the vessel, or so that wind or water currents carry the vessel into the path of the whales).

The endangered Southern Resident killer whales are a small population with only 86 whales in the population at the end of 2010. The Southern Residents underwent an almost 20 percent decline from 1996 to 2001, and while there were several years of population increases following 2001, there have also been recent years with declines.

Our listing decision and the Recovery Plan for Southern Resident killer whales identified three major threats to their continued existence, all of which likely act in concert—prey availability, contaminants, and vessel effects and sound. While we and others in the region are working to restore salmon runs and minimize contamination in Puget Sound, these efforts will likely take many years to provide benefits for killer whales. In contrast, the threats posed by vessels can be reduced quickly by regulating vessel activities. The primary objective of promulgating these regulations is to manage the threats to killer whales from vessels, in support of the recovery of Southern Residents.

Monitoring groups such as Soundwatch have reported that the mean number of vessels following a given group of whales within1/2mile increased from five boats in 1990 to an average of about 15-20 boats during May through September, for the years 1998 through 2010 (Osborneet al.1999; Baird 2001; Erbe 2002; Marine Mammal Monitoring Project 2002; Koski 2004, 2006, 2007, 2008, 2009, 2010a, 2010b). At any one time, the observed numbers of commercial and recreational whale watch boats around killer whales can be much higher. Monitoring groups have collected several years of data on incidents when vessels are not adhering to the guidelines and the whales may be disturbed. From 2006-2010, there were between 1,085 (2007) and 2,527 (2009) reported incidents per year where vessels did not follow the guidelines during the time the observers were present (Koski 2007, 2008, 2009, 2010a, 2010b). Since observers were not present during all days and all hours, it is likely that there were more incidents than those reported. In 2009, there were 2,527 incidents, and the majority were committed by private boaters (72 percent) and Canadian commercial operators (8 percent). Of the 1,067 incidents in 2010, the majority were committed by private boaters (64 percent) and Canadian commercial operators (10 percent) (Koski 2010a, 2010b). The most common incidents also reflect this pattern and are most often committed by private boaters and Canadian commercial whale watch vessels. The four most commonly observed incidents in 2010, and for the last several years, were parking in the path, vessels motoring inshore of whales, vessels motoring within 100 yards (91.4 m) of whales, and vessels motoring fast within 400 yards (365.8 m) of the whales (Koski 2008, 2009, 2010a, 2010b).

For the summer of 2010, Soundwatch's Kayak Education and Leadership Program (KELP), San Juan County Parks, and the San Juan Island Kayak Association worked together to update and refine a Kayaker Code of Conduct as part of KELP. In addition to providing the guidelines and training for kayakers through the KELP education program, Soundwatch also monitored kayak activity and compliance of kayakers with the recommendations in the code of conduct to augment the Soundwatch vessel monitoring program. From June through September 2010, 594 incidents were observed (66 percent commercial and 28 percent private) and the most common incidents were kayaks not rafted, parked on headland or within kelp bed, parked in the path of whales and stopped within 100 yards (91.4 m) of whales.

The specific threats from these vessel incidents include (1) risk of strikes, which can result in injury or mortality, (2) behavioral disturbance, which increases energy expenditure and reduces foraging opportunities, and (3) acoustic masking, which interferes with echolocation and foraging, as well as communication. Southern and Northern Resident killer whales have been injured or killed by collisions with vessels. Some whales have sustained injuries from propeller blades and have eventually recovered, one was instantly killed, and several mortalities of stranded animals have been attributed to vessel strikes in recent years (Visser 1999; Fordet al.2000; Visser and Fertl2000; Baird 2001; Carrettaet al.2001, 2004, Gaydos and Raverty 2007).

As described in the background section of this final rule and in the EA, it is well documented that killer whales in the Pacific Northwest respond to vessels engaged in whale watching (including kayaks) with short-term behavioral changes. Examples of short-term behavioral responses include increases in direction changes, respiratory intervals, and surface active behaviors, all of which can increase energy expenditure (Bainet al.2006; Norenet al.2007, 2009; Williamset al.2009). Southern Residents also spend less time foraging in the presence of vessels (Bainet al.2006, Lusseauet al.2009; Giles and Cendak 2010; Williamset al.2010). Williamset al.(2006) estimated that increased energy expenditure may be less important than the reduced time spent feeding and the resulting likely reduction in prey consumption in the presence of vessels. Vessels in the path of the whales can interfere with important social behaviors such as prey sharing (Ford and Ellis 2006) or with behaviors that generally occur in a forward path as the whales are moving, such as nursing (Kriete 2007).

Vessel sounds may mask or compete with and effectively drown out calls made by killer whales, including echolocation used to locate prey and other signals the whales rely upon for communication and navigation. Masking of echolocation reduces foraging efficiency (Holt 2009), which may be particularly problematic if prey resources are limited. Vessel noise was predicted to significantly reduce the range at which echolocating killer whales could detect salmon in the water column. Holt (2009) reported that the detection range for a killer whale echolocating on a Chinook salmon could be reduced 88 to 100 percent by the presence of a moving vessel within 100 yards (91.4 m) of the whale. Masking sound from vessels could affect the ability of whales to coordinate their feeding activities, including searching for prey and prey sharing. Footeet al.(2004) attributed increased duration of primary communication calls to increased vessel traffic and a recent study also found similar increased durations for a larger number of calls (Wielandet al.2010). Holtet al.(2009) found that killer whales increase their call amplitude in response to vessel noise.

Energetic costs from increased behavioral disturbance and reduced foraging can decrease the fitness of individuals (Lusseau and Bejder 2007). Energy expenditure or disruption of foraging could result in poor nutrition. Poor nutrition could lead to reproductive or immune effects, or, if severe enough, to mortality. Interference with foraging can affect growth and development, which in turn can affect the age at which animals reach reproductive maturity, fecundity, and annual or lifetime reproductive success. Interference with essential behaviors, including prey sharing and communication, could also reduce social cohesion and foraging efficiency for Southern Resident killer whales, and, therefore, the growth, reproduction, and fitness of individuals. Injuries from vessel strikes could also affect the health and fitness of individuals. Any injury to or reduction in fitness of a single member of the Southern Resident killer whale population is serious because of the small population size.

To reduce the risk of vessel strikes, behavioral disturbance, and acoustic masking, and to manage effectively the threat from vessels, regulations must reduce the current number of harmful vessel incidents. Monitoring demonstrates that there are numerous incidents in which the current voluntary guidelines are not observed. Researchers in other regions have also reported low compliance with voluntary guidelines designed to protect other endangered whales (Wileyet al.2008). Research suggests that vessel operators are more likely to comply with mandatory regulations than with voluntary guidelines (May 2005). In addition, level of compliance is likely to depend on how easy the regulations are to understand, follow and enforce. We therefore expect that clear mandatory regulations will reduce the number of incidents, compared to the current voluntary guidelines.

After analyzing a range of alternative regulations, we concluded that the most appropriate measures to protect the whales are a combination of an approach regulation and a prohibition on parking in the path. We recognize that adopting regulations that are different from the current voluntary guidelines and State law may present some challenges. The current infrastructure, however, includes enforcement, monitoring, and stewardship groups, who will be available to assist with an education campaign to inform boaters about the new regulations and the scientific information on which they are based. The combination of two measures as part of the regulation package provides multiple tools for enforcement that are measurable, easy for the public to understand, and based on the best available science regarding vessel impacts. The final EA contains a full analysis of a No-action alternative, six individual alternatives, the proposed regulations combining three elements and the final regulation combining two elements, described below.

200-yard (182.9 m) approach regulation.A regulation prohibiting approaches closer than 200 yards (182.9 m) will be clear to whale watch operators. These operators will likely know about such a regulation and be able to accurately judge the distance of their vessels from whales, as indicated by their current high levels of compliance with the current 100-yard (91.4 m) guideline. Recreational boaters would be less likely to know about such a regulation, though over time it is reasonable to expect that familiarity with the regulation would increase, particularly with education and publicity about any prosecutions. Some recreational boaters may also follow the example of commercial operators to determine the proper viewing distance.

The 200-yard (182.9 m) approach regulation is intended to reduce the risk of vessel strikes, the degree of behavioral disruption, and the amount of noise that masks echolocation and communication. Current research results have documented behavioral disturbance and estimated a considerable potential for masking from vessels at 100 yards (91.4 m). These effects are reduced at 200 yards (182.9 m) and greater distances. Some effects are observed up to 400 yards (365.8 m) from the whales. While an approach regulation at a distance greater than 200 yards (182.9 m) would further reduce vessel effects, this could diminish both the experience of whale watching and opportunities to participate in whale watching. We recognize that whale watching educates the public about whales and fosters stewardship. We balanced the benefits to killer whales of a greater approach distance regulation and continued whale watching opportunities, and we arrived at the 200-yard (182.9 m) approach regulation.

Parking in the path prohibition.As described above, parking in the path of a whale is a common violation of the current guidelines by commercial whale watch operators and an increasing number of private boaters. It also carries one of the greatest risks, since it increases the chance of vessel strike. This regulation is consistent with the current guidelines and therefore already understood by commercial whale watch operators. A prohibition on parking in the path complements the approach regulation, which prohibits approaching within 200 yards (182.9 m) of thewhales, including by interception. The path regulation provides the best management tool for improving compliance and reducing the risk of vessel strikes and masking from vessels directly in front of the whales. The risk of vessel strikes and masking are both most severe when vessels are directly in front of the whales. By instituting a mandatory regulation in place of a voluntary guideline, we expect increased compliance, particularly by the commercial operators who are most often in the path of the whales.

The final regulations for killer whales differ from protective regulations promulgated to protect other marine mammal species in other locations. In each case the development of regulations was based on the biology of the marine mammal species and available information on the nature of the threats. For the Southern Resident killer whales, we have detailed information on killer whale biology, vessel activities around the whales, and vessel effects on the whales' behavior and acoustic foraging activities that informed the selection of the final rule.

We did not propose some of the regulatory options suggested in the ANPR and in public comments on the proposed rule for several reasons, including, difficulties in enforcing them, changes to infrastructure needed to implement them, or a lack of sufficient science to support them. For example, a speed limit within a certain distance of the whales (i.e.,less than 7 knots within 400 yards (365.8 m) of the whales) would be difficult to implement and enforce without vessel tracking technology. A permit or certification program would require a large infrastructure to implement. There would also be equity issues in determining who is permitted or certified and who is not. A moratorium on all vessel-based whale watching, or protected areas along all shorelines, would be challenging to enforce and is not supported by available scientific information. Some comments suggested regulatory options such as rerouting shipping lanes or imposing noise level standards, which would unnecessarily restrict some types of vessels rarely in close proximity to the whales.

We considered both benefits and costs in selecting the final regulation. The reduction in threats for each element of the regulation package as described above provides a benefit to the whales, as well as to the public who value the whales. Reducing threats to the whales also supports the long-term sustainability of the whale watching industry. The regulations also provide benefits to some land-based viewing and may provide benefits to other marine species. In addition to the benefits, we also considered the potential costs of the proposed regulations. To limit some potential costs to vessels or industries rarely in close proximity to the whales, we have included several exemptions to the regulations (i.e.,ships in shipping lanes, fishing vessels). The exemptions also prevent other potential costs by protecting public safety, allowing for critical government and permitted activities to continue, and allowing us to fulfill our treaty trust responsibilities.

The costs of implementing vessel regulations to protect the whales will likely be greatest for the commercial whale watch industry and recreational whale watchers. One cost of the proposed regulations is to increase viewing distance, which may affect the quality of whale watching experiences. An increased viewing distance affects the experience of the whale watch participants and not necessarily the revenue of the industry or companies. While some commercial whale watch operators have suggested that increased viewing distance will affect their revenue, there is information indicating that proximity to the whales is not the most important aspect of whale watching, and that participants value viewing in a manner that respects the whales. We do not anticipate any loss of business or reduction in the number of opportunities for participating in whale watching activities. Other impacts to boaters are expected to be minor and include slight deviations of a vessel's path in order to comply with the regulations. Additionally, due to the need for these regulations to facilitate recovery of the Southern Resident population, we anticipate that the continued recovery of the population will result in broad-based benefit to the general public.

In developing these regulations, we have determined that current regulations and guidelines are not sufficient to protect endangered Southern Resident killer whales and that additional regulations are necessary to reduce the risk of extinction. While we cannot quantify the reduction in risk of extinction, the perilous status of the Southern Residents makes it appropriate to take all reasonable actions to improve their chances of survival and recovery. We are issuing appropriate final regulations to reduce threats posed by vessels, limit costs, and maintain opportunities for the public to participate in whale watching. Of the alternatives considered, we chose a combination of two which provide benefits. All of the options have relatively low socioeconomic and recreation costs. In contrast, the cost of extinction of Southern Residents is incalculable. The final regulations will have a net benefit to the whales and the public who value the whales.

The success of this program is vital to the recovery of the species. Therefore, NMFS will monitor the effectiveness of the final regulations and consider altering the measures or implementing additional measures if appropriate.

A complete list of all references cited in this proposed rule can be found on our Web site athttp://www.nwr.noaa.gov/and is available upon request from the NMFS office in Seattle, Washington (seeADDRESSES).

NMFS has prepared a final EA and Finding of No Significant Impact (FONSI) pursuant to NEPA to support this final rule. NMFS was the lead agency for the analysis and the U.S. Coast Guard, Washington Department of Fish and Wildlife, and the Department of Fisheries and Oceans, Canada were cooperating agencies. The final EA also includes a Regulatory Impact Review. An economic report and Regulatory Impact Review, including an analysis under the Regulatory Flexibility Act, were prepared to support the regulation. The Final Regulatory Flexibility Analysis (FRFA) is included in Chapter 6 of the final EA.

IEC (2010) identified a total of 283 small business entities that may be affected by the vessel regulations to protect killer whales implemented by this final rule. This includes 23 small businesses in the whale watching industry, 248 in fishing related industry, and 12 in freight transportation. NMFS considered 9 alternatives for this rulemaking, which are:

Alternative 1: No-action;

Alternative 2: 100-Yard (91.4 m) Approach Regulation;

Alternative 3: 200-Yard (182.9 m) Approach Regulation;

Alternative 4: Protected Area—Current Voluntary No-go Zone;

Alternative 5: Protected Area—Expanded No-go Zone;

Alternative 6: Speed Limit of 7 Knots Within 400 Yards (365.8 m) of Killer Whales;

Alternative 7: Keep Clear of the Whales' Path;

Alternative 8: Proposed Action (Package of Alternatives 3, 5, and 7); and

Alternative 9: Preferred Alternative (Package of Alternatives 3 and 7).

Chapter 2 of the final EA describes each of the 9 alternatives that were analyzed. A summary of the impacts of each of the 9 alternatives is provided below. For detailed information on the costs of each alternative, see Chapter 4 of the final EA. For a summary of the costs and benefits of each alternative, see Table 6-1 found in Chapter 6 of the final EA. The cost of the No Action Alternative is the potential loss of the whale watch industry based on an increased extinction risk for the whales. While operations of the whale watch industry may be affected to different degrees by Alternatives 2 through 9, it is the customers and not necessarily the whale watching companies (i.e.,small entities for the purposes of RFA) who may bear impacts. The economic analysis (IEC 2010) projects no change in revenue for whale watching operations or other industries, but rather the potential diminished value of the customers' experience as a result of greater viewing distances and displacement of vessels.

The economic analysis and final EA quantify the number of trips and participating individuals for different types of vessels (commercial whale watch, private whale watching, kayaking, and fishing) that would be potentially affected by Alternatives 2 through 9. A small number of commercial and private whale watching trips, kayak and fishing trips would have to adjust their operations to comply with Alternative 2 (a 100-yard (91.4 m) Approach Regulation). Under Alternative 3 (a 200-yard (182.9 m) Approach Regulation) there was a range of estimated trips and individuals that would experience greater viewing distance which included up to all participants in commercial and private whale watching trips. There was some uncertainty regarding the potential effects of Alternatives 4 and 5 (Current and Expanded No-go Zones), which included increased viewing distances for a small percent of all commercial and private whale watching trips and displacement of a large number of commercial and recreational kayaks from the San Juan County boat launch and a smaller number of commercial fishing vessels from the no-go zone. A small number of commercial and private whale watching trips, kayak and fishing trips would be affected by having to comply with Alternative 6 (a Speed Limit of 7 Knots Within 400 Yards (365.8 m) of Killer Whales) similar to the numbers for Alternative 2 (the 100-Yard (91.4 m) Approach Regulation). A larger number of commercial whale watching trips and similar small number of private whale watching trips would be affected by Alternative 7 (Keep Clear the Whales' Path) compared to Alternatives 2 and 6. Alternative 8 is a combination of Alternatives 3, 5 and 7 and would have the greatest impacts of all the action alternatives. Alternative 9 is a combination of Alternatives 3 and 7 and would have fewer impacts than Alternative 8, but greater impacts than the individual alternatives (Alternatives 2 through 7).

The benefits of two alternatives, Alternatives 3 and 7, are high and Alternative 9 combines these individual regulations into an action with high benefit. The expected costs are minimal for each alternative. The costs associated with Alternatives 2 through 9, as estimated by the number of commercial and recreational trips and passengers affected vary, and in some cases the overall number of trips and passengers affected are small (Alternatives 2, 4, 6, and 7). For other alternatives (Alternatives 3, 5, 8 and 9) there is some uncertainty as to the number of trips and passengers affected. Even if all participants in recreational and commercial whale watching are affected, the impact itself (based on an increased viewing distance) is small. Alternative 8 with the highest benefit and small costs provides the highest net benefit. Alternative 9 also has a high benefit and small costs, providing a net benefit. Alternative 9 does not include Alternative 5 (the Expanded No-go Zone). However, NMFS recognizes the increased benefit to the whales of reducing vessel impacts in a core foraging area and will collect additional information and seek public input to further evaluate the concept of a no-go zone. While there may be some economic cost to various industry groups under Alternative 9, particularly commercial whale watching, overall this cost is likely to be minimal and outweighed by the conservation benefits of regulations. NMFS does not expect any small entity to cease operation as a result of any of the alternatives, including the Preferred Alternative (Alternative 9). The primary costs under the Preferred Alternative (Alternative 9) are a diminished value to individuals engaged in whale watching at greater distances and would not be borne by these small entities. Additional information on selection of the Preferred Alternative (Alternative 9) is included in the Rationale for Regulations section of this final rule. The final EA including the FONSI and FRFA, Regulatory Impact Review, and supporting documents are available for review and can be found on the NMFS Northwest Region Web site athttp://www.nwr.noaa.gov/.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you believe that we have not met these requirements, send us comments (seeADDRESSESsection). To better help us revise rules in the future, your comments should be as specific as possible.

This final rule will not impose any new requirements for collection of information that requires approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501et seq.) This rule will not impose new recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations.

This Final Rule was determined to be significant for purposes of E.O. 12866. It was reviewed by the Office of Management and Budget and other interested Federal agencies.

We have determined that this final rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of E.O. 12988. We issue protective regulations pursuant to provisions in the ESA and MMPA using an existing approach that improves the clarity of the regulations and minimizes the regulatory burden of managing ESA listings while retaining necessary and advisable protections to provide for the conservation of threatened and endangered species.

The longstanding and distinctive relationship between the Federal andtribal governments is defined by treaties, statutes, executive orders, judicial decisions, and co-management agreements. These differentiate tribal governments from the other entities that deal with, or are affected by, the Federal Government. This relationship has given rise to a special Federal trust responsibility involving the legal responsibilities and obligations of the United States toward Indian Tribes and the application of fiduciary standards of due care with respect to Indian lands, tribal trust resources, and the exercise of tribal rights. E.O. 13175 outlines the responsibilities of the Federal Government in matters affecting tribal interests. During our scoping process we provided the opportunity for all interested tribes to comment on the need for regulations and discuss any concerns they may have. The Lummi Tribe and the Northwest Indian Fisheries Commission provided comments on the proposed rule regarding the exception for treaty Indian fishing vessels. In response to the comments, NMFS included additional clarification regarding the specific treaty fishing activities to which the exception applies. See Comment 9: Exceptions. We will continue to coordinate with the tribes on management and conservation actions related to this species.

E.O. 13132 requires agencies to take into account any federalism impacts of regulations under development. It includes specific consultation directives for situations where a regulation will preempt state law, or impose substantial direct compliance costs on state and local governments (unless required by statute). The Washington Department of Fish and Wildlife (WDFW) was a cooperating agency on the NEPA analysis to support development of proposed regulations. A Federal regulation under the MMPA and ESA prohibiting approach within 200 yards (182.9 m) of killer whales is more protective than the state law (RCW 15.77.740), which prohibits approach within 100 yards (91.4 m) of Southern Resident killer whales in state waters, and therefore may preempt the state law. In their comments on the proposed rule, WDFW supported federal regulations prohibiting approach within 200 yards (182.9 m) of killer whales. Inclusion of the WDFW as a cooperating agency satisfies the consultation requirements of E.O. 13132.

E.O. 13211 requires agencies to prepare a statement of energy effects when undertaking certain actions. According to E.O. 13211, “significant energy action” means any action by an agency that is expected to lead to the promulgation of a final rule or regulation that is a significant regulatory action under E.O. 12866 and is likely to have a significant adverse effect on the supply, distribution, or use of energy. We have determined that the energy effects of this final rule are unlikely to exceed the energy impact thresholds identified in E.O. 13211 and that this rulemaking is, therefore, not a significant energy action. No statement of energy effects is required.

For the reasons set out in the preamble, 50 CFR part 224 is amended as follows:

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

NMFS closed directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI under § 679.20(d)(1)(iii) on April 4, 2011 (76 FR 18663, April 5, 2011).

As of April 6, 2011, NMFS has determined that approximately 2,000 metric tons remain in the directed fishing allowance of Pacific cod allocated to catcher vessels using trawl gear in the BSAI. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the B season allowance of the 2011 TAC of Pacific cod allocated to catcher vessels using trawl gear in the BSAI, NMFS is terminating the previous closure and is reopening directed fishing Pacific cod by catcher vessels using trawl gear in the BSAI. The Administrator, Alaska Region, NMFS, (Regional Administrator) considered the following factors in reaching this decision: (1) The current catch of Pacific cod by catcher vessels using trawl gear in the BSAI and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will be reached after 72 hours. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI effective 1200 hrs, A.l.t., April 12, 2011.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of directed fishing for Pacific cod by catcher vessels using trawl gear in the BSAI. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet and processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of April 6, 2011.

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

Without this inseason adjustment, NMFS could not allow the B season allowance of the 2011 TAC of Pacific cod allocated to catcher vessels using trawl gear in the BSAI to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until April 25, 2011.

This action is required by § 679.25 and is exempt from review under Executive Order 12866.