Gulf of the Farallones and Monterey Bay National Marine Sanctuaries Regulations on Introduced Species, 50740-50744 [E9-23576]
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[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): https://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 https://
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.
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*
*
*
*
(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
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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
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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 https://farallones.noaa.gov.
NOAA established the MBNMS in
1992 for the purposes of protecting and
managing the conservation, ecological,
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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 https://
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.
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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.
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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,
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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
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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
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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
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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
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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 https://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
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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: https://
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 https://
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
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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): https://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 https://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 https://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 https://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 https://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]
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