Gulf of the Farallones and Monterey Bay National Marine Sanctuaries Regulations on Introduced Species, 50740-50744 [E9-23576]

Download as PDF 50740 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules [Docket No. 0907301210–91239–01] be exhibited, at any location other than their designated primary facility. Estimated annual number of respondents: 300. Estimated annual number of responses per respondent: 8.66. Estimated annual number of responses: 2,600. Estimated total annual burden on respondents: 650 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS Information Collection Coordinator, at (301) 851–2908. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS Information Collection Coordinator, at (301) 851– 2908. for exhibition at any location other than the person(s) approved site(s). (1) The itinerary shall include the following: (i) The name(s) of the person(s) who intends to exhibit the animal(s) and transport the animal(s) for exhibition purposes, including any business name(s) and current AWA license or registration number(s) and, in the event that any animal is leased, borrowed, loaned, or under some similar arrangement, the name of the person who owns such animal; (ii) The name, identification number or identifying characteristics, species (common or scientific name), sex and age of each animal; and (iii) The names, dates, and locations (with addresses), where the animals will travel, be housed, and be exhibited, including all anticipated dates and locations (with addresses) for any stops and layovers. (2) The itinerary shall be promptly revised, as necessary, to account for any changes. terms of designation to regulate introduced species in these sanctuaries were unacceptable in State waters of the sanctuaries. In response to the Governor’s letter, NOAA is proposing to modify its regulations to except all State-permitted aquaculture activities in the two sanctuaries. DATES: Comments must be received by November 16, 2009. ADDRESSES: You may submit comments by any of the following methods: • Electronic submission (preferred method): http://www.regulations.gov (search for docket # NOAA–NOS–2009– 0105). • Mail: John Armor, Office of National Marine Sanctuaries, 1305 EastWest Highway, Silver Spring, Maryland 20910. Instructions: All comments received are a part of the public record and will be generally posted to http:// www.regulations.gov without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information. NOAA will accept anonymous comments (enter N/A in the required fields, if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only. FOR FURTHER INFORMATION CONTACT: John Armor, Office of National Marine Sanctuaries, 1305 East-West Highway, Silver Spring, MD 20910, or by phone at 301–713–3125. SUPPLEMENTARY INFORMATION: RIN 0648–AX83 I. Background Gulf of the Farallones and Monterey Bay National Marine Sanctuaries Regulations on Introduced Species A. GFNMS and MBNMS Background Done in Washington, DC, this 25th day of September 2009. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E9–23679 Filed 9–30–09; 8:45 am] BILLING CODE 3410–34–P List of Subjects in 9 CFR Part 2 Animal welfare, Pets, Reporting and recordkeeping requirements, Research. Accordingly, we propose to amend 9 CFR part 2 as follows: PART 2—REGULATIONS Authority: 7 U.S.C. 2131–2159; 7 CFR 2.22, 2.80, and 371.7. 2. In § 2.126, the section heading is revised and a new paragraph (c) is added to read as follows: § 2.126 Access and inspection of records and property; submission of itineraries. jlentini on DSKJ8SOYB1PROD with PROPOSALS * * * * (c) Any person who is subject to the Animal Welfare regulations and who intends to exhibit any animal at any location other than the person’s approved site(s) (including, but not limited to, circuses, traveling educational exhibits, animal acts, and petting zoos) shall submit a written itinerary to the Animal Care Regional Director. The itinerary shall be received by the Animal Care Regional Director no fewer than 2 days in advance of any travel and shall contain complete and accurate information concerning the whereabouts of any animal(s) intended VerDate Nov<24>2008 17:15 Sep 30, 2009 Jkt 217001 National Oceanic and Atmospheric Administration 15 CFR Part 922 1. The authority citation for part 2 continues to read as follows: * DEPARTMENT OF COMMERCE AGENCY: Office of National Marine Sanctuaries (ONMS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC). ACTION: Notice of proposed rulemaking; request for public comments. SUMMARY: The National Oceanic and Atmospheric Administration (NOAA) is proposing to revise its regulations on the introduction of introduced species into the Gulf of the Farallones and Monterey Bay national marine sanctuaries (GFNMS and MBNMS, respectively). This action is being taken in response to a letter received by the Governor of California on December 23, 2008. The Governor certified that the PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 NOAA established the GFNMS in 1981 to protect and preserve a unique and fragile ecological community, including the largest seabird colony in the contiguous United States and diverse and abundant marine mammals. The GFNMS lies off the coast of California, to the west and north of San Francisco, and is composed of 1,279 square statute miles (966 square nautical miles) of offshore waters and submerged lands thereunder. The sanctuary boundary extends out to and around the Farallon Islands and nearshore waters (up to the mean high water line) from Bodega Head to Rocky Point in Marin. For more information about the GFNMS, see http://farallones.noaa.gov. NOAA established the MBNMS in 1992 for the purposes of protecting and managing the conservation, ecological, E:\FR\FM\01OCP1.SGM 01OCP1 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules jlentini on DSKJ8SOYB1PROD with PROPOSALS recreational, research, educational, historical, and esthetic resources and qualities of the area. The MBNMS is located offshore of California’s central coast, adjacent to and south of the GFNMS. It encompasses a shoreline length of approximately 276 statute miles (240 nmi) between Rocky Pt. in Marin County and Cambria in San Luis Obispo County. The sanctuary spans approximately 6,094 square statute miles (4,602 square nautical miles) of ocean and coastal waters, and the submerged lands thereunder, extending an average distance of 30 statute miles (26 nmi) from shore. The Davidson Seamount is also part of the sanctuary, though it does not share a contiguous boundary. Supporting some of the world’s most diverse marine ecosystems, the MBNMS is home to numerous mammals, seabirds, fishes, invertebrates, sea turtles and plants in a remarkably productive coastal environment. For more information about the MBNMS, please see http:// montereybay.noaa.gov. B. Regulatory Background Pursuant to section 304(e) of the National Marine Sanctuaries Act (16 U.S.C. 1434 et seq.) (NMSA), the Office of National Marine Sanctuaries (ONMS) conducted a joint review of the management plans for the Gulf of the Farallones, Monterey Bay and Cordell Bank national marine sanctuaries. This review resulted in revised management plans, regulations, and terms of designation for all three sanctuaries. On November 20, 2008, NOAA published the associated final rule and terms of designation (73 FR 70488) and released the revised management plans. Pursuant to section 304(b) of the National Marine Sanctuaries Act (NMSA), changes to a sanctuary’s terms of designation and the associated regulations do not become effective until after forty-five days of continuous session of Congress. After forty-five days, in this case on March 9, 2009, the regulations would become final and take effect, except that any term of designation the Governor certified as unacceptable would not take effect in the area of a sanctuary lying within the seaward boundary of the State (‘‘State waters’’). If exercised, the effect of a gubernatorial objection is that the term(s) of designation do not become effective in State waters. Any regulations that rely on the change in terms of designation also do not become effective in State waters. In the November 20, 2008 final rule, NOAA changed the terms of designation for the GFNMS and MBNMS to clearly allow regulation of introduced species. VerDate Nov<24>2008 17:15 Sep 30, 2009 Jkt 217001 Pursuant to section 304(b) of the NMSA, the Governor could accept or reject those changes to the terms of designation. C. Certification by the Governor of California On December 23, 2008, during the forty-five day review period under the NMSA, the Governor of the State of California certified by letter to the Secretary of Commerce that certain terms of designation regarding regulation of the introduction of introduced species in State waters were unacceptable. The following is the text of the December 23, 2008, letter from the Governor of California to the United States Secretary of Commerce. December 23, 2008 Honorable Carlos M. Gutierrez Secretary of Commerce 1401 Constitution Avenue Northwest Washington, DC 20230. Dear Mr. Secretary: Since the designation of the Channel Islands National Marine Sanctuary in 1981, the National Oceanic and Atmospheric Administration’s Office of National Marine Sanctuaries (ONMS) and the State of California have been working together to ensure the protection of our special and unique national marine sanctuaries. California very much appreciates the strong working relationship we have with our Federal partners, and I think we’ve done a lot of good work together to protect our coastal and ocean resources and to educate Californians about the importance of these resources. In 2001, ONMS initiated a process to review and update the management plans and corresponding regulations of the three national marine sanctuaries off the California coast: Monterey Bay, Gulf of the Farallones and Cordell Bank. In October 2006, ONMS released the draft management plans and a draft environmental impact statement. In January 2007, the State of California submitted comments to ONMS. Since then, the State of California and ONMS have successfully resolved all concern regarding proposed regulations, with the exception of the following proposed regulations regarding introduced species: For Gulf of the Farallones National Marine Sanctuary § 922.82(10): Introducing or otherwise releasing from within or into the Sanctuary and introduced species except: (A) Striped bass (Morone saxatilis) released during catch and release fishing activity; or (B) Species cultivated by mariculture activities in Tomales Bay pursuant to a valid lease, permit, license or other authorization issued by the State of California and in effect on the effective date of the final regulation. For Monterey Bay National Marine Sanctuary § 922.132(12): Introducing or otherwise releasing from within or into the Sanctuary an introduced species, except striped bass (Morone saxatilis) released during catch and release fishing activity. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 50741 We agree with ONMS’s assertion that introduced species can threaten our ocean and coastal ecosystems if not properly managed in the context of an aquaculture program. However, we object to the proposed regulations for several reasons: 1. There is no authority in either State of Federal law for the proposition that all nonnative species are necessarily detrimental to native wildlife and must therefore be prohibited. 2. The California State legislature has not granted any submerged lands to the Federal government that would enable a sanctuary to assert authority over aquaculture operations in State waters. 3. The release of harmful non-native species is already controlled under State law, and any proposed introduction of non-native aquaculture species is subject to multiple agency review and to the California Environmental Quality Act. In our January 2007 comment letter, the State of California suggested the following changes to the proposed regulations (deletions noted in italics and additions in UPPERCASE font): For Gulf of the Farallones National Marine Sanctuary § 922.82(10): Introducing or otherwise releasing from within or into the Sanctuary and introduced species, except: (A) Striped bass (MORONE SAXATILIS) released during catch and release fishing activity; or (B) Species cultivated by mariculture activities in Tomales Bay pursuant to a valid lease, permit, license or other authorization issued by the State of California and in effect on the effective date of the final regulation. For Monterey Bay National Marine Sanctuary § 922.132(12): Introducing or otherwise releasing from within or into the Sanctuary and introduced species, except striped bass (MORONE SAXATILIS) released during catch and release fishing activity OR THROUGH MARICULTURE OR RESEARCH ACTIVITIES CONDUCTED PURSUANT TO A VALID LEASE, PERMIT, LICENSE OR OTHER AUTHORIZATION ISSUED BY THE STATE OF CALIFORNIA. These changes will allow us to protect sanctuary resources from introduced species without conflicting with State authority to manage aquaculture in State waters. Despite the concerns expressed by the State of California, ONMS included these proposed regulations in the final environmental impact statement dated September 15, 2008, and the notice in the Federal Register dated November 20, 2008. If ONMS in unable or unwilling to make the requested changes, I hereby use the authority given to me by the National Marine Sanctuaries Act (16 U.S.C. 1434(b)(1)) to certify that certain terms in the designation documents of the Gulf of the Farallones and Monterey Bay National Marine Sanctuaries are unacceptable. As a result, the unacceptable term of designation document shall not take effect in the area of the sanctuary lying within the seaward boundary of the State of California. For the Gulf of the Farallones National Marine Sanctuary, I certify that Article IV, E:\FR\FM\01OCP1.SGM 01OCP1 50742 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules jlentini on DSKJ8SOYB1PROD with PROPOSALS section 1(e) of the designation document is unacceptable. Article IV, section 1(e) reads, ‘‘Introducing or otherwise releasing from within or into the Sanctuary an introduced species.’’ For the Monterey Bay National Marine Sanctuary, I certify that Article IV, section 1(l) of the designation document is unacceptable. Article IV, section 1(l) reads, ‘‘Introducing or otherwise releasing from within or into the Sanctuary an introduced species.’’ ONMS and the State of California have been working together for almost 30 years to ensure the protection of the national marine sanctuaries off California’s coast. In the spirit of this ongoing partnership, I urge ONMS to respect the State of California’s sovereign right to manage its resources in State waters, and I ask that ONMS make the requested changes in the Gulf of the Farallones and Monterey Bay National Marine Sanctuaries proposed regulations and designation documents. I look forward to continuing to work with you on this important issue. Sincerely, Arnold Schwarzenegger D. NOAA’s Response to the Governor In his letter, the Governor indicated that the State of California’s concerns were clearly articulated in its comments on the proposed rule (71 FR 59338, October 6, 2006). However, NOAA believes the State’s position on the introduced species regulation was not clear. During the comment period on the proposed rule, NOAA received comments from the California Department of Fish and Game (CDFG), the California Department of Boating and Waterways (CDBW), the California Coastal Commission (CCC), and California State Lands Commission. The CDFG and CDBW both opposed NOAA’s prohibition on the introduction of introduced species but the two commissions were either silent or explicitly supportive of it. To add further complexity to the State’s position, the CCC—exercising its authority under the Federal consistency provisions of the Coastal Zone Management Act—specifically, rejected the CDFGs requested change and stated that NOAA must maintain the prohibition on introduced species as it was written in the proposed rule or else the final regulations would not be consistent with the enforceable policies of the California Coastal Management Program, which NOAA complies with. Therefore, NOAA did not anticipate the State of California’s position on the matter when NOAA received the Governor’s objection letter after the final rule was issued. NOAA notes that the proposed and final regulations were drafted with a significant level of input from State agencies and commissions. The current VerDate Nov<24>2008 17:15 Sep 30, 2009 Jkt 217001 language was developed following numerous consultations with State personnel when NOAA first began the process of changing the terms of designation and regulations for the sanctuaries. For example, during consultations with the State of California, concern was expressed that striped bass would qualify as an introduced species and that an angler who catches and then releases a striped bass to comply with State imposed site restrictions would be in violation of the proposed regulation. Because prohibiting such activity was not the intent of the regulation, to address this concern, NOAA drafted the regulation to except striped bass, the only introduced species for which there is an active fishery. After receiving the Governor’s letter, NOAA worked with staff from the California Natural Resources Agency and the California Department of Fish and Game to find solutions to the Governor’s concerns that would also meet NOAA’s goals. As such, NOAA agreed to modify the regulations on introduced species to except Statepermitted aquaculture in GFNMS. NOAA agreed to not enforce the invasive species provisions in the State waters of the GFNMS until NOAA could initiate a new rulemaking to consider the issue more closely and to consider public comment on the matter. NOAA did not agree, however, to allow the research exception involving the introduction of introduced species in the MBNMS, as the Governor requested. In subsequent discussions with the State, NOAA was not provided with a reason why such an exemption would be needed. Neither the Governor nor the agencies with which NOAA worked at the State of California provided any description of how this exception would be used, what types of research activities would qualify, or what the effect of it would be on sanctuary resources. NOAA noted to the State of California’s Natural Resources Agency that if, in the future, there were a research proposal that involved the introduction of introduced species, the regulations would still allow NOAA to issue a permit, in coordination with the relevant State agencies, that would allow the research project to proceed. Therefore, NOAA explained to the State, the potential consequences to the sanctuary of excepting research from the introduced species regulation far outweighed the potential administrative consequences of issuing a regulation that would require researchers to obtain a permit from NOAA for the introduction of introduced species. The PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 State rejected this option and, because no compromise was attained, the Governor’s objection to the term of designation for the regulation of introduced species in the State waters of the MBNMS stands. As indicated in the notice of effective date (March 23, 2009; 74 FR 12088), the regulation of the introduction of introduced species from within or into the MBNMS is valid and in effect in the area of the sanctuary lying beyond the seaward boundary of the State only. II. Summary of the Proposed Revisions to the Regulation of Introduction of Introduced Species in GFNMS The regulations for the GFNMS currently prohibit introducing or otherwise releasing from within or into the sanctuary (1) an introduced species, except striped bass (Morone saxatilis) released during catch and release fishing activity; and (2) species cultivated by mariculture activities in Tomales Bay pursuant to a valid lease, permit, license or other authorization issued by the State of California and in effect on the effective date of the final regulation. As proposed, the revised regulations for the GFNMS would remove the geographic reference to Tomales Bay and would revise the exception so as to allow the Statepermitted mariculture activities in the area of the sanctuary that is within the seaward boundary of the State. The term ‘‘introduced species’’ is defined as: (1) Any species (including, but not limited to, any of its biological matter capable of propagation) that is non-native to the ecosystems of the Sanctuary; or (2) any organism into which altered genetic matter, or genetic matter from another species, has been transferred in order that the host organism acquires the genetic traits of the transferred genes. NOAA issued this regulation due to the threats introduced species pose to endangered species and native species diversity. For example, a number of non-native species now found in the Gulf of the Farallones and Monterey Bay regions were introduced elsewhere on the west coast but have spread through vectors such as vessel hull-fouling, ballast water discharge, and accidental introductions. NOAA also stated that introduced species are a major economic and environmental threat to the living resources and habitats of a sanctuary as well as the commercial and recreational uses that depend on these resources. Once established, introduced species can be extremely difficult, if not impossible, to eradicate. Introduced species have become increasingly common in recent decades, and the rate E:\FR\FM\01OCP1.SGM 01OCP1 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules jlentini on DSKJ8SOYB1PROD with PROPOSALS of invasions continues to accelerate at a rapid pace. Threatened and endangered species are particularly vulnerable to invasion. As such, NOAA continues to believe it is important to regulate the introduction of introduced species in a manner that is consistent with the sanctuary’s and NMSA’s goals. NOAA believes that the compromise language provided by the Governor of California would meet the objectives. Therefore, NOAA proposes to amend § 922.82(a)(10) as requested by the Governor, to expand the geographic and temporal scope of the exception for introduced species through Statepermitted aquaculture in State waters. If adopted, these changes would change the geographic restriction of mariculture activities in Tomales Bay to all of the State waters. The new regulations would also remove the temporal component of the current regulations, allowing the State of California to issue additional permits for these activities. III. Summary of the Revisions to MBNMS Regulations In issuing the November 20, 2008 final rule, NOAA revised the MBNMS terms of designation to modify the list of activities that may be regulated. As revised, the terms of designation clearly authorize the regulation of ‘‘introducing or otherwise releasing from within or into the sanctuary an introduced species.’’ This revision was intended to enable NOAA to more effectively and efficiently address new and emerging resource management issues, and was necessary in order to ensure protection, preservation, and management of the conservation, recreational, ecological, historical, cultural, educational, archeological, scientific, and esthetic resources and qualities of the MBNMS. However, this new term of designation does not apply to the State-waters part of the MBNMS due to the Governor’s objection. NOAA indicated this in the notice of effective date (March 23, 2009; 74 FR 10488). As such, that specific term of designation should now read, ‘‘introducing or otherwise releasing from within or into the Federal waters of the sanctuary an introduced species.’’ NOAA is proposing to modify the regulation associated with this term of designation to reflect the Governor of California’s certification of this term as unacceptable. NOAA proposes to update the regulations, at subpart M, § 922. 132(a)(12), to conform with the Governor’s objection so the scope of this portion of the JMPR’s November 20, 2008 final rule will only apply to the area of the Sanctuary lying beyond the VerDate Nov<24>2008 17:15 Sep 30, 2009 Jkt 217001 50743 seaward boundary of the State of California. Game, and the California Natural Resources Agency. IV. Miscellaneous Rulemaking Requirements E. Regulatory Flexibility Act The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification is as follows: Using the SBA’s Small Business Size Standards, NOAA determined that the small business concerns operating within the both of the sanctuaries include: Commercial fishermen who vary in number seasonally and annually from approximately 300 to 500 boats; twelve mariculture leaseholders in Tomales Bay (in GFNMS); approximately 25 recreational charterfishing businesses; and approximately 7 recreational charter businesses engaged in wildlife viewing. The small organizations, as defined under 5 U.S.C. 601(4), that would be impacted by this rule include approximately 3 small organizations operating within the GFNMS, which include nongovernmental organizations (NGOs) and/or non-profit organizations (NPOs) dedicated to environmental education, research, restoration, and conservation concerning marine and maritime heritage resources. The small governmental jurisdictions, as defined under 5 U.S.C. 601(5), that would be impacted by this rule are the Bodega, Bolinas and Tomales Bay settlements that are directly adjacent to the GFNMS. The prohibition on releasing or otherwise introducing from within or into the GFNMS and in the area of the MBNMS lying beyond the seaward boundary of the State an introduced species is not expected to significantly adversely impact small entities because this activity is not part of the business or operational practices associated with most of the small entities that would be impacted by this rule. Small entities whose operational practices may include catch and release of striped bass (Roccus saxatilis), (i.e., consumptive recreational charter businesses), would not be affected because the prohibition would not apply to the catch and release of fish already present in the sanctuaries. In fact, the prohibition against introduced species may result in indirect benefits for certain small entities since their activities could potentially be negatively impacted by the spread of introduced species. The mariculture leaseholders located adjacent to the GFNMS may, however, be potentially impacted by this A. National Marine Sanctuaries Act Section 301(b) of the National Marine Sanctuaries Act (16 U.S.C. 1434) provides authority for comprehensive and coordinated conservation and management of national marine sanctuaries in coordination with other resource management authorities. Section 304(a)(4) of the National Marine Sanctuaries Act requires the procedures specified in section 304 for designating a national marine sanctuary be followed for modifying any term of designation. This action does not propose to revise the terms of designation for either sanctuary. B. National Environmental Policy Act NOAA prepared a final environmental impact statement (FEIS) to evaluate regulating the introduction of introduced species off the California coast. NOAA identified a preferred action in that FEIS, but is now proposing to implement a different action based on the Governor’s letter of December 23, 2008. NOAA has analyzed the impacts of this action in the FEIS for the joint management plan review for the three national marine sanctuaries on the central California coast (availability of which was announced in the Federal Register on September 26, 2008; 73 FR 55843). NOAA intends to issue a new record of decision (ROD) with regard to this action. Copies of the FEIS are available at http://sanctuaries.noaa.gov/ jointplan/feis/feis.html, or by contacting NOAA at the address listed in the Address section of this proposed rule. C. Executive Order 12866: Regulatory Impact This proposed rule has been determined to be not significant within the meaning of Executive Order 12866. D. Executive Order 13132: Federalism Assessment NOAA has concluded that this regulatory action falls within the definition of ‘‘policies that have federalism implications’’ within the meaning of Executive Order 13132. The changes will not preempt State law, but will simply update sanctuary regulations to comply with the Governor’s action. In keeping with the intent of the Executive Order, the NOAA consulted with a number of entities within the State which participated in development of the initial rule, including but not limited to, the California Department of Fish and PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\01OCP1.SGM 01OCP1 50744 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Proposed Rules proposed rule. Under the current regulations, existing leaseholders are excepted from the introduced species prohibition if they have active lease agreements at the time of implementation of the regulation (the regulation took effect on March 9, 2009). Under the proposed rule for the GFNMS, this exemption will no longer contain a geographic restriction of Tomales Bay, and will no longer restrict new permits from being issued through the State (as opposed to through the ONMS). This prohibition would not put any current operations out of business, because they will not need to change anything about their current procedures to continue in their operations. A beneficial effect from this proposed action may result for existing and future lease holders, such as reduced administrative burden for issuance or renewal of a lease permit. Comments received on the economic impacts of this proposed rule will be summarized and responded to in the final rule. F. Paperwork Reduction Act This proposed rule does not contain information collections that are subject to the requirements of the Paperwork Reduction Act. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. jlentini on DSKJ8SOYB1PROD with PROPOSALS Subpart M—Monterey Bay National Marine Sanctuary 3. Section 922.132(a)(12) is amended to read as follows: § 922.132 Prohibited or otherwise regulated activities. (a) * * * (12) Introducing or otherwise releasing from within or into the area of the Sanctuary lying beyond the seaward boundary of the State of California an introduced species, except striped bass (Morone saxatilis) released during catch and release fishing activity. * * * * * Submit electronic comments in the following ways: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • FAX: 301–827–6870. • Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by email. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the ADDRESSES portion of this document under Electronic Submissions. Instructions: All submissions received must include the agency name and docket number and Regulatory Information Number (RIN) for this rulemaking. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 4 [Docket No. FDA–2008–N–0424] Postmarketing Safety Reporting for Combination Products Accordingly, for the reasons set forth above, 15 CFR part 922 is amended as follows: PART 922—NATIONAL MARINE SANCTUARY PROGRAM REGULATIONS 1. The authority citation for Part 922 continues to read as follows: Jkt 217001 (a) * * * (10) Introducing or otherwise releasing from within or into the Sanctuary an introduced species, except: (i) Striped bass (Morone saxatilis) released during catch and release fishing activity; or (ii) Species cultivated by a mariculture activity within the area of the sanctuary lying within the seaward boundary of the State of California and authorized by a valid lease, permit, license or other authorization issued by the State. * * * * * RIN 0910–AF82 Dated: September 24, 2009. William Corso, Deputy Assistant Administrator for Ocean Services and Coastal Zone Management. 17:15 Sep 30, 2009 § 922.82 Prohibited or otherwise regulated activities. BILLING CODE 3510–NK–P List of Subjects in 15 CFR Part 922 Administrative practice and procedure, Environmental protection, Fish, Harbors, Marine pollution, Marine resources, Natural resources, Penalties, Recreation and recreation areas, Research, Water pollution control, Water resources, Wildlife. VerDate Nov<24>2008 2. Section 922.82(a)(10) is amended to read as follows: reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA’s ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. DATES: Submit written or electronic comments on the proposed rule by December 30, 2009. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 2, 2009, (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: You may submit comments, identified by Docket No. FDA–2008–N– 0424 and/or RIN number 0910–AF82, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). [FR Doc. E9–23576 Filed 9–30–09; 8:45 am] V. Request for Comments NOAA requests comments on this proposed rule for 45 days after publication of this notice. Authority: 16 U.S.C. 1431 et seq. Subpart H—Gulf of the Farallones National Marine Sanctuary AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 Electronic Submissions E:\FR\FM\01OCP1.SGM 01OCP1

Agencies

[Federal Register Volume 74, Number 189 (Thursday, October 1, 2009)]
[Proposed Rules]
[Pages 50740-50744]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23576]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

15 CFR Part 922

[Docket No. 0907301210-91239-01]
RIN 0648-AX83


Gulf of the Farallones and Monterey Bay National Marine 
Sanctuaries Regulations on Introduced Species

AGENCY: Office of National Marine Sanctuaries (ONMS), National Oceanic 
and Atmospheric Administration (NOAA), Department of Commerce (DOC).

ACTION: Notice of proposed rulemaking; request for public comments.

-----------------------------------------------------------------------

SUMMARY: The National Oceanic and Atmospheric Administration (NOAA) is 
proposing to revise its regulations on the introduction of introduced 
species into the Gulf of the Farallones and Monterey Bay national 
marine sanctuaries (GFNMS and MBNMS, respectively). This action is 
being taken in response to a letter received by the Governor of 
California on December 23, 2008. The Governor certified that the terms 
of designation to regulate introduced species in these sanctuaries were 
unacceptable in State waters of the sanctuaries. In response to the 
Governor's letter, NOAA is proposing to modify its regulations to 
except all State-permitted aquaculture activities in the two 
sanctuaries.

DATES: Comments must be received by November 16, 2009.

ADDRESSES: You may submit comments by any of the following methods:
     Electronic submission (preferred method): http://www.regulations.gov (search for docket  NOAA-NOS-2009-0105).
     Mail: John Armor, Office of National Marine Sanctuaries, 
1305 East-West Highway, Silver Spring, Maryland 20910.
    Instructions: All comments received are a part of the public record 
and will be generally posted to http://www.regulations.gov without 
change. All Personal Identifying Information (for example, name, 
address, etc.) voluntarily submitted by the commenter may be publicly 
accessible. Do not submit confidential business information or 
otherwise sensitive or protected information. NOAA will accept 
anonymous comments (enter N/A in the required fields, if you wish to 
remain anonymous). Attachments to electronic comments will be accepted 
in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.

FOR FURTHER INFORMATION CONTACT: John Armor, Office of National Marine 
Sanctuaries, 1305 East-West Highway, Silver Spring, MD 20910, or by 
phone at 301-713-3125.

SUPPLEMENTARY INFORMATION:

I. Background

A. GFNMS and MBNMS Background

    NOAA established the GFNMS in 1981 to protect and preserve a unique 
and fragile ecological community, including the largest seabird colony 
in the contiguous United States and diverse and abundant marine 
mammals. The GFNMS lies off the coast of California, to the west and 
north of San Francisco, and is composed of 1,279 square statute miles 
(966 square nautical miles) of offshore waters and submerged lands 
thereunder. The sanctuary boundary extends out to and around the 
Farallon Islands and nearshore waters (up to the mean high water line) 
from Bodega Head to Rocky Point in Marin. For more information about 
the GFNMS, see http://farallones.noaa.gov.
    NOAA established the MBNMS in 1992 for the purposes of protecting 
and managing the conservation, ecological,

[[Page 50741]]

recreational, research, educational, historical, and esthetic resources 
and qualities of the area. The MBNMS is located offshore of 
California's central coast, adjacent to and south of the GFNMS. It 
encompasses a shoreline length of approximately 276 statute miles (240 
nmi) between Rocky Pt. in Marin County and Cambria in San Luis Obispo 
County. The sanctuary spans approximately 6,094 square statute miles 
(4,602 square nautical miles) of ocean and coastal waters, and the 
submerged lands thereunder, extending an average distance of 30 statute 
miles (26 nmi) from shore. The Davidson Seamount is also part of the 
sanctuary, though it does not share a contiguous boundary. Supporting 
some of the world's most diverse marine ecosystems, the MBNMS is home 
to numerous mammals, seabirds, fishes, invertebrates, sea turtles and 
plants in a remarkably productive coastal environment. For more 
information about the MBNMS, please see http://montereybay.noaa.gov.

B. Regulatory Background

    Pursuant to section 304(e) of the National Marine Sanctuaries Act 
(16 U.S.C. 1434 et seq.) (NMSA), the Office of National Marine 
Sanctuaries (ONMS) conducted a joint review of the management plans for 
the Gulf of the Farallones, Monterey Bay and Cordell Bank national 
marine sanctuaries. This review resulted in revised management plans, 
regulations, and terms of designation for all three sanctuaries. On 
November 20, 2008, NOAA published the associated final rule and terms 
of designation (73 FR 70488) and released the revised management plans.
    Pursuant to section 304(b) of the National Marine Sanctuaries Act 
(NMSA), changes to a sanctuary's terms of designation and the 
associated regulations do not become effective until after forty-five 
days of continuous session of Congress. After forty-five days, in this 
case on March 9, 2009, the regulations would become final and take 
effect, except that any term of designation the Governor certified as 
unacceptable would not take effect in the area of a sanctuary lying 
within the seaward boundary of the State (``State waters''). If 
exercised, the effect of a gubernatorial objection is that the term(s) 
of designation do not become effective in State waters. Any regulations 
that rely on the change in terms of designation also do not become 
effective in State waters.
    In the November 20, 2008 final rule, NOAA changed the terms of 
designation for the GFNMS and MBNMS to clearly allow regulation of 
introduced species. Pursuant to section 304(b) of the NMSA, the 
Governor could accept or reject those changes to the terms of 
designation.

C. Certification by the Governor of California

    On December 23, 2008, during the forty-five day review period under 
the NMSA, the Governor of the State of California certified by letter 
to the Secretary of Commerce that certain terms of designation 
regarding regulation of the introduction of introduced species in State 
waters were unacceptable. The following is the text of the December 23, 
2008, letter from the Governor of California to the United States 
Secretary of Commerce.

December 23, 2008
Honorable Carlos M. Gutierrez
Secretary of Commerce
1401 Constitution Avenue Northwest
Washington, DC 20230.

Dear Mr. Secretary:

    Since the designation of the Channel Islands National Marine 
Sanctuary in 1981, the National Oceanic and Atmospheric 
Administration's Office of National Marine Sanctuaries (ONMS) and 
the State of California have been working together to ensure the 
protection of our special and unique national marine sanctuaries. 
California very much appreciates the strong working relationship we 
have with our Federal partners, and I think we've done a lot of good 
work together to protect our coastal and ocean resources and to 
educate Californians about the importance of these resources.
    In 2001, ONMS initiated a process to review and update the 
management plans and corresponding regulations of the three national 
marine sanctuaries off the California coast: Monterey Bay, Gulf of 
the Farallones and Cordell Bank. In October 2006, ONMS released the 
draft management plans and a draft environmental impact statement. 
In January 2007, the State of California submitted comments to ONMS. 
Since then, the State of California and ONMS have successfully 
resolved all concern regarding proposed regulations, with the 
exception of the following proposed regulations regarding introduced 
species:
    For Gulf of the Farallones National Marine Sanctuary Sec.  
922.82(10):
    Introducing or otherwise releasing from within or into the 
Sanctuary and introduced species except:
    (A) Striped bass (Morone saxatilis) released during catch and 
release fishing activity; or
    (B) Species cultivated by mariculture activities in Tomales Bay 
pursuant to a valid lease, permit, license or other authorization 
issued by the State of California and in effect on the effective 
date of the final regulation.
    For Monterey Bay National Marine Sanctuary Sec.  922.132(12):
    Introducing or otherwise releasing from within or into the 
Sanctuary an introduced species, except striped bass (Morone 
saxatilis) released during catch and release fishing activity.
    We agree with ONMS's assertion that introduced species can 
threaten our ocean and coastal ecosystems if not properly managed in 
the context of an aquaculture program. However, we object to the 
proposed regulations for several reasons:
    1. There is no authority in either State of Federal law for the 
proposition that all non-native species are necessarily detrimental 
to native wildlife and must therefore be prohibited.
    2. The California State legislature has not granted any 
submerged lands to the Federal government that would enable a 
sanctuary to assert authority over aquaculture operations in State 
waters.
    3. The release of harmful non-native species is already 
controlled under State law, and any proposed introduction of non-
native aquaculture species is subject to multiple agency review and 
to the California Environmental Quality Act.
    In our January 2007 comment letter, the State of California 
suggested the following changes to the proposed regulations 
(deletions noted in italics and additions in UPPERCASE font):
    For Gulf of the Farallones National Marine Sanctuary Sec.  
922.82(10):
    Introducing or otherwise releasing from within or into the 
Sanctuary and introduced species, except:
    (A) Striped bass (MORONE SAXATILIS) released during catch and 
release fishing activity; or
    (B) Species cultivated by mariculture activities in Tomales Bay 
pursuant to a valid lease, permit, license or other authorization 
issued by the State of California and in effect on the effective 
date of the final regulation.
    For Monterey Bay National Marine Sanctuary Sec.  922.132(12):
    Introducing or otherwise releasing from within or into the 
Sanctuary and introduced species, except striped bass (MORONE 
SAXATILIS) released during catch and release fishing activity OR 
THROUGH MARICULTURE OR RESEARCH ACTIVITIES CONDUCTED PURSUANT TO A 
VALID LEASE, PERMIT, LICENSE OR OTHER AUTHORIZATION ISSUED BY THE 
STATE OF CALIFORNIA.
    These changes will allow us to protect sanctuary resources from 
introduced species without conflicting with State authority to 
manage aquaculture in State waters.
    Despite the concerns expressed by the State of California, ONMS 
included these proposed regulations in the final environmental 
impact statement dated September 15, 2008, and the notice in the 
Federal Register dated November 20, 2008.
    If ONMS in unable or unwilling to make the requested changes, I 
hereby use the authority given to me by the National Marine 
Sanctuaries Act (16 U.S.C. 1434(b)(1)) to certify that certain terms 
in the designation documents of the Gulf of the Farallones and 
Monterey Bay National Marine Sanctuaries are unacceptable. As a 
result, the unacceptable term of designation document shall not take 
effect in the area of the sanctuary lying within the seaward 
boundary of the State of California.
    For the Gulf of the Farallones National Marine Sanctuary, I 
certify that Article IV,

[[Page 50742]]

section 1(e) of the designation document is unacceptable. Article 
IV, section 1(e) reads, ``Introducing or otherwise releasing from 
within or into the Sanctuary an introduced species.''
    For the Monterey Bay National Marine Sanctuary, I certify that 
Article IV, section 1(l) of the designation document is 
unacceptable. Article IV, section 1(l) reads, ``Introducing or 
otherwise releasing from within or into the Sanctuary an introduced 
species.''
    ONMS and the State of California have been working together for 
almost 30 years to ensure the protection of the national marine 
sanctuaries off California's coast. In the spirit of this ongoing 
partnership, I urge ONMS to respect the State of California's 
sovereign right to manage its resources in State waters, and I ask 
that ONMS make the requested changes in the Gulf of the Farallones 
and Monterey Bay National Marine Sanctuaries proposed regulations 
and designation documents. I look forward to continuing to work with 
you on this important issue.

 Sincerely,

Arnold Schwarzenegger

D. NOAA's Response to the Governor

    In his letter, the Governor indicated that the State of 
California's concerns were clearly articulated in its comments on the 
proposed rule (71 FR 59338, October 6, 2006). However, NOAA believes 
the State's position on the introduced species regulation was not 
clear. During the comment period on the proposed rule, NOAA received 
comments from the California Department of Fish and Game (CDFG), the 
California Department of Boating and Waterways (CDBW), the California 
Coastal Commission (CCC), and California State Lands Commission. The 
CDFG and CDBW both opposed NOAA's prohibition on the introduction of 
introduced species but the two commissions were either silent or 
explicitly supportive of it. To add further complexity to the State's 
position, the CCC--exercising its authority under the Federal 
consistency provisions of the Coastal Zone Management Act--
specifically, rejected the CDFGs requested change and stated that NOAA 
must maintain the prohibition on introduced species as it was written 
in the proposed rule or else the final regulations would not be 
consistent with the enforceable policies of the California Coastal 
Management Program, which NOAA complies with. Therefore, NOAA did not 
anticipate the State of California's position on the matter when NOAA 
received the Governor's objection letter after the final rule was 
issued.
    NOAA notes that the proposed and final regulations were drafted 
with a significant level of input from State agencies and commissions. 
The current language was developed following numerous consultations 
with State personnel when NOAA first began the process of changing the 
terms of designation and regulations for the sanctuaries. For example, 
during consultations with the State of California, concern was 
expressed that striped bass would qualify as an introduced species and 
that an angler who catches and then releases a striped bass to comply 
with State imposed site restrictions would be in violation of the 
proposed regulation. Because prohibiting such activity was not the 
intent of the regulation, to address this concern, NOAA drafted the 
regulation to except striped bass, the only introduced species for 
which there is an active fishery.
    After receiving the Governor's letter, NOAA worked with staff from 
the California Natural Resources Agency and the California Department 
of Fish and Game to find solutions to the Governor's concerns that 
would also meet NOAA's goals. As such, NOAA agreed to modify the 
regulations on introduced species to except State-permitted aquaculture 
in GFNMS. NOAA agreed to not enforce the invasive species provisions in 
the State waters of the GFNMS until NOAA could initiate a new 
rulemaking to consider the issue more closely and to consider public 
comment on the matter.
    NOAA did not agree, however, to allow the research exception 
involving the introduction of introduced species in the MBNMS, as the 
Governor requested. In subsequent discussions with the State, NOAA was 
not provided with a reason why such an exemption would be needed. 
Neither the Governor nor the agencies with which NOAA worked at the 
State of California provided any description of how this exception 
would be used, what types of research activities would qualify, or what 
the effect of it would be on sanctuary resources.
    NOAA noted to the State of California's Natural Resources Agency 
that if, in the future, there were a research proposal that involved 
the introduction of introduced species, the regulations would still 
allow NOAA to issue a permit, in coordination with the relevant State 
agencies, that would allow the research project to proceed. Therefore, 
NOAA explained to the State, the potential consequences to the 
sanctuary of excepting research from the introduced species regulation 
far outweighed the potential administrative consequences of issuing a 
regulation that would require researchers to obtain a permit from NOAA 
for the introduction of introduced species. The State rejected this 
option and, because no compromise was attained, the Governor's 
objection to the term of designation for the regulation of introduced 
species in the State waters of the MBNMS stands. As indicated in the 
notice of effective date (March 23, 2009; 74 FR 12088), the regulation 
of the introduction of introduced species from within or into the MBNMS 
is valid and in effect in the area of the sanctuary lying beyond the 
seaward boundary of the State only.

II. Summary of the Proposed Revisions to the Regulation of Introduction 
of Introduced Species in GFNMS

    The regulations for the GFNMS currently prohibit introducing or 
otherwise releasing from within or into the sanctuary (1) an introduced 
species, except striped bass (Morone saxatilis) released during catch 
and release fishing activity; and (2) species cultivated by mariculture 
activities in Tomales Bay pursuant to a valid lease, permit, license or 
other authorization issued by the State of California and in effect on 
the effective date of the final regulation. As proposed, the revised 
regulations for the GFNMS would remove the geographic reference to 
Tomales Bay and would revise the exception so as to allow the State-
permitted mariculture activities in the area of the sanctuary that is 
within the seaward boundary of the State.
    The term ``introduced species'' is defined as: (1) Any species 
(including, but not limited to, any of its biological matter capable of 
propagation) that is non-native to the ecosystems of the Sanctuary; or 
(2) any organism into which altered genetic matter, or genetic matter 
from another species, has been transferred in order that the host 
organism acquires the genetic traits of the transferred genes.
    NOAA issued this regulation due to the threats introduced species 
pose to endangered species and native species diversity. For example, a 
number of non-native species now found in the Gulf of the Farallones 
and Monterey Bay regions were introduced elsewhere on the west coast 
but have spread through vectors such as vessel hull-fouling, ballast 
water discharge, and accidental introductions. NOAA also stated that 
introduced species are a major economic and environmental threat to the 
living resources and habitats of a sanctuary as well as the commercial 
and recreational uses that depend on these resources. Once established, 
introduced species can be extremely difficult, if not impossible, to 
eradicate. Introduced species have become increasingly common in recent 
decades, and the rate

[[Page 50743]]

of invasions continues to accelerate at a rapid pace. Threatened and 
endangered species are particularly vulnerable to invasion.
    As such, NOAA continues to believe it is important to regulate the 
introduction of introduced species in a manner that is consistent with 
the sanctuary's and NMSA's goals. NOAA believes that the compromise 
language provided by the Governor of California would meet the 
objectives. Therefore, NOAA proposes to amend Sec.  922.82(a)(10) as 
requested by the Governor, to expand the geographic and temporal scope 
of the exception for introduced species through State-permitted 
aquaculture in State waters. If adopted, these changes would change the 
geographic restriction of mariculture activities in Tomales Bay to all 
of the State waters. The new regulations would also remove the temporal 
component of the current regulations, allowing the State of California 
to issue additional permits for these activities.

III. Summary of the Revisions to MBNMS Regulations

    In issuing the November 20, 2008 final rule, NOAA revised the MBNMS 
terms of designation to modify the list of activities that may be 
regulated. As revised, the terms of designation clearly authorize the 
regulation of ``introducing or otherwise releasing from within or into 
the sanctuary an introduced species.'' This revision was intended to 
enable NOAA to more effectively and efficiently address new and 
emerging resource management issues, and was necessary in order to 
ensure protection, preservation, and management of the conservation, 
recreational, ecological, historical, cultural, educational, 
archeological, scientific, and esthetic resources and qualities of the 
MBNMS. However, this new term of designation does not apply to the 
State-waters part of the MBNMS due to the Governor's objection. NOAA 
indicated this in the notice of effective date (March 23, 2009; 74 FR 
10488). As such, that specific term of designation should now read, 
``introducing or otherwise releasing from within or into the Federal 
waters of the sanctuary an introduced species.'' NOAA is proposing to 
modify the regulation associated with this term of designation to 
reflect the Governor of California's certification of this term as 
unacceptable.
    NOAA proposes to update the regulations, at subpart M, Sec.  922. 
132(a)(12), to conform with the Governor's objection so the scope of 
this portion of the JMPR's November 20, 2008 final rule will only apply 
to the area of the Sanctuary lying beyond the seaward boundary of the 
State of California.

IV. Miscellaneous Rulemaking Requirements

A. National Marine Sanctuaries Act

    Section 301(b) of the National Marine Sanctuaries Act (16 U.S.C. 
1434) provides authority for comprehensive and coordinated conservation 
and management of national marine sanctuaries in coordination with 
other resource management authorities. Section 304(a)(4) of the 
National Marine Sanctuaries Act requires the procedures specified in 
section 304 for designating a national marine sanctuary be followed for 
modifying any term of designation. This action does not propose to 
revise the terms of designation for either sanctuary.

B. National Environmental Policy Act

    NOAA prepared a final environmental impact statement (FEIS) to 
evaluate regulating the introduction of introduced species off the 
California coast. NOAA identified a preferred action in that FEIS, but 
is now proposing to implement a different action based on the 
Governor's letter of December 23, 2008. NOAA has analyzed the impacts 
of this action in the FEIS for the joint management plan review for the 
three national marine sanctuaries on the central California coast 
(availability of which was announced in the Federal Register on 
September 26, 2008; 73 FR 55843). NOAA intends to issue a new record of 
decision (ROD) with regard to this action. Copies of the FEIS are 
available at http://sanctuaries.noaa.gov/jointplan/feis/feis.html, or 
by contacting NOAA at the address listed in the Address section of this 
proposed rule.

C. Executive Order 12866: Regulatory Impact

    This proposed rule has been determined to be not significant within 
the meaning of Executive Order 12866.

D. Executive Order 13132: Federalism Assessment

    NOAA has concluded that this regulatory action falls within the 
definition of ``policies that have federalism implications'' within the 
meaning of Executive Order 13132. The changes will not preempt State 
law, but will simply update sanctuary regulations to comply with the 
Governor's action. In keeping with the intent of the Executive Order, 
the NOAA consulted with a number of entities within the State which 
participated in development of the initial rule, including but not 
limited to, the California Department of Fish and Game, and the 
California Natural Resources Agency.

E. Regulatory Flexibility Act

    The Chief Counsel for Regulation of the Department of Commerce 
certified to the Chief Counsel for Advocacy of the Small Business 
Administration this rule, if adopted, would not have a significant 
economic impact on a substantial number of small entities. The factual 
basis for this certification is as follows:
    Using the SBA's Small Business Size Standards, NOAA determined that 
the small business concerns operating within the both of the 
sanctuaries include: Commercial fishermen who vary in number seasonally 
and annually from approximately 300 to 500 boats; twelve mariculture 
leaseholders in Tomales Bay (in GFNMS); approximately 25 recreational 
charter-fishing businesses; and approximately 7 recreational charter 
businesses engaged in wildlife viewing. The small organizations, as 
defined under 5 U.S.C. 601(4), that would be impacted by this rule 
include approximately 3 small organizations operating within the GFNMS, 
which include non-governmental organizations (NGOs) and/or non-profit 
organizations (NPOs) dedicated to environmental education, research, 
restoration, and conservation concerning marine and maritime heritage 
resources. The small governmental jurisdictions, as defined under 5 
U.S.C. 601(5), that would be impacted by this rule are the Bodega, 
Bolinas and Tomales Bay settlements that are directly adjacent to the 
GFNMS.
    The prohibition on releasing or otherwise introducing from within 
or into the GFNMS and in the area of the MBNMS lying beyond the seaward 
boundary of the State an introduced species is not expected to 
significantly adversely impact small entities because this activity is 
not part of the business or operational practices associated with most 
of the small entities that would be impacted by this rule. Small 
entities whose operational practices may include catch and release of 
striped bass (Roccus saxatilis), (i.e., consumptive recreational 
charter businesses), would not be affected because the prohibition 
would not apply to the catch and release of fish already present in the 
sanctuaries. In fact, the prohibition against introduced species may 
result in indirect benefits for certain small entities since their 
activities could potentially be negatively impacted by the spread of 
introduced species.
    The mariculture leaseholders located adjacent to the GFNMS may, 
however, be potentially impacted by this

[[Page 50744]]

proposed rule. Under the current regulations, existing leaseholders are 
excepted from the introduced species prohibition if they have active 
lease agreements at the time of implementation of the regulation (the 
regulation took effect on March 9, 2009). Under the proposed rule for 
the GFNMS, this exemption will no longer contain a geographic 
restriction of Tomales Bay, and will no longer restrict new permits 
from being issued through the State (as opposed to through the ONMS). 
This prohibition would not put any current operations out of business, 
because they will not need to change anything about their current 
procedures to continue in their operations. A beneficial effect from 
this proposed action may result for existing and future lease holders, 
such as reduced administrative burden for issuance or renewal of a 
lease permit. Comments received on the economic impacts of this 
proposed rule will be summarized and responded to in the final rule.

F. Paperwork Reduction Act

    This proposed rule does not contain information collections that 
are subject to the requirements of the Paperwork Reduction Act. 
Notwithstanding any other provision of the law, no person is required 
to respond to, nor shall any person be subject to a penalty for failure 
to comply with, a collection of information subject to the requirements 
of the PRA, unless that collection of information displays a currently 
valid OMB Control Number.

V. Request for Comments

    NOAA requests comments on this proposed rule for 45 days after 
publication of this notice.

List of Subjects in 15 CFR Part 922

    Administrative practice and procedure, Environmental protection, 
Fish, Harbors, Marine pollution, Marine resources, Natural resources, 
Penalties, Recreation and recreation areas, Research, Water pollution 
control, Water resources, Wildlife.

    Dated: September 24, 2009.
William Corso,
Deputy Assistant Administrator for Ocean Services and Coastal Zone 
Management.

    Accordingly, for the reasons set forth above, 15 CFR part 922 is 
amended as follows:

PART 922--NATIONAL MARINE SANCTUARY PROGRAM REGULATIONS

    1. The authority citation for Part 922 continues to read as 
follows:

    Authority: 16 U.S.C. 1431 et seq.

Subpart H--Gulf of the Farallones National Marine Sanctuary

    2. Section 922.82(a)(10) is amended to read as follows:


Sec.  922.82  Prohibited or otherwise regulated activities.

    (a) * * *
    (10) Introducing or otherwise releasing from within or into the 
Sanctuary an introduced species, except:
    (i) Striped bass (Morone saxatilis) released during catch and 
release fishing activity; or
    (ii) Species cultivated by a mariculture activity within the area 
of the sanctuary lying within the seaward boundary of the State of 
California and authorized by a valid lease, permit, license or other 
authorization issued by the State.
* * * * *

Subpart M--Monterey Bay National Marine Sanctuary

    3. Section 922.132(a)(12) is amended to read as follows:


Sec.  922.132  Prohibited or otherwise regulated activities.

    (a) * * *
    (12) Introducing or otherwise releasing from within or into the 
area of the Sanctuary lying beyond the seaward boundary of the State of 
California an introduced species, except striped bass (Morone 
saxatilis) released during catch and release fishing activity.
* * * * *

[FR Doc. E9-23576 Filed 9-30-09; 8:45 am]
BILLING CODE 3510-NK-P