[Federal Register: November 12, 2002 (Volume 67, Number 218)]
[Proposed Rules]
[Page 68553-68556]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no02-27]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 216
[Docket No. 021017237-2237-01; I.D. 090302F]
RIN 0648-AQ51
Protocol for Access to Tissue Specimen Samples from the National
Marine Mammal Tissue Bank
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Proposed rule.
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SUMMARY: The NMFS proposes to make available tissue specimen samples to
the scientific community for research that is consistent with the goals
of the National Marine Mammal Tissue Bank (NMMTB) and the Marine Mammal
Health and Stranding Response Program (MMHSRP). The intent of this
proposed rule is to allow the scientific community the opportunity to
comment on the protocol for requests for tissue specimen samples from
the NMMTB.
DATES: Comments must be received by 5 p.m. EST on December 12, 2002.
Comments transmitted via e-mail will not be accepted.
ADDRESSES: Submit your comment(s) to Marine Mammal Health and Stranding
Response Program (MMHSRP), Program Manager, NOAA, NMFS, Office of
Protected Resources, 1315 East-West Highway, Silver Spring, MD 20910-
3282. Comments may also be sent via facsimile (fax) to 301-713-0376. To
submit e-Comments (see SUPPLEMENTARY INFORMATION.)
FOR FURTHER INFORMATION CONTACT: Dr. Teri Rowles, Marine Mammal Health
and Stranding Response Program, 301-713-2322 ext 178.
SUPPLEMENTARY INFORMATION:
E-Comments Pilot Program
NMFS encourages the public to participate in this proposed
rulemaking by submitting comments. To this end, NMFS is accepting
comments by submitted mail, fax, and the Internet as part of its e-
Comments pilot project (see ADDRESSES). The e-Comments pilot project is
designed to introduce electronic rulemaking to NMFS an its
constituents. The public is encouraged to use the new web site to
compose and submit comments on this proposed rule and the associated
supporting documents to help NMFS fully evaluate this new technology.
In submitting comments, please include your name and address, indicate
if you are commenting on the proposed rule or other rulemaking
documents, and give the reason for each comment. If you are commenting
on the proposed rule, indicate to which specific section each comment
applies. NMFS also invites public comments on the e-Comments program
that allows you to submit your comments on line. NMFS will consider all
comments received during the comment period, regardless of how they
were submitted, and NMFS may make changes in the final rule in
consideration of them. Please submit your comments by only one means.
Comments received from the public will become part of the public record
and will be posted on the e-Comments web site http://
ocio.nmfs.noaa.gov/ibrm-ssi/index.shtml after the comment period
closes.
Electronic Access
Several of the background documents for the MMHSRP and the NMMTB
Specimen Access Policy can be downloaded from the Health and Stranding
Response Program web site at
[[Page 68554]]
http://www.nmfs.noaa.gov/prot--res/.
PR2.
Background
The NMMTB was established in 1992 and provides protocols,
techniques, and physical facilities for the long-term storage of
tissues from marine mammals. Scientists can request tissues from this
repository for retrospective analyses to determine environmental trends
of contaminants and other analytes of interest. The NMMTB is currently
managed in collaboration with the National Institute of Standards and
Technology (NIST) and is housed at the Hollins Marine Laboratory in
Charleston, SC and the NIST campus in Gaithersburg, MD as part of the
National Biomonitoring Specimen Bank. The NMMTB collects, processes,
and stores tissues from specific indicator species (e.g., Atlantic
bottlenose dolphins, Atlantic white sided dolphins, pilot whales,
harbor porpoise), animals from mass strandings, animals that have been
obtained incidental to commercial fisheries, animals taken for
subsistence purposes, biopsies, and animals from unusual mortality
events.
Each tissue specimen consists of duplicate samples (denoted A and
B) of approximately 150 g. each. These duplicate samples are banked in
the NMMTB in separate liquid nitrogen vaporphase freezers and are
maintained at -150oC. When a portion of a tissue specimen is requested
for analysis, the ``B'' sample of that specimen can be cryogenically
homogenized and aliquoted into approximately 20 subsamples of 6 to 8 g.
each. The ``A'' sample of each specimen remains as a bulk sample and
will only be homogenized after all portions from the corresponding
``B'' sample have been depleted and there is sufficient justification
to homogenize the remaining material. Thus, 50 percent of each specimen
is available to the scientific community for research and scientific
evaluations consistent with the goals of the NMMTB and 50 percent is
intended for long-term storage as a more permanent archive for decades.
The goal of the NMMTB is to maintain quality controlled marine mammal
tissues that will permit retrospective analyses to determine
environmental trends of contaminants and other analytes of interest and
that will provide the highest quality samples for analyses using new
and innovative techniques.
Under 16 U.S.C. 1421f, section 407(d)(1) of the Marine Mammal
Protection Act, the NMFS must establish criteria for access to marine
mammal tissues in the NMMTB and make those criteria available for
public review and comment. In addition, NMFS must establish criteria
for access to tissue analyses conducted pursuant to 16 U.S.C. 1421f,
section 407(b) and data in the central marine mammal data base
maintained under 16 U.S.C. 1421f, section 407(c). NMFS will establish
these additional criteria in subsequent rulemaking.
There is only a very limited amount of samples available and the
applicants for tissue specimen samples from the NMMTB will need to
demonstrate that their research will fulfill the goals of the NMMTB and
MMHSRP and that comparable tissue samples to accomplish the goals of
the proposed research could not be readily obtained from other sources.
The goal of the MMHSRP is to facilitate the collection and
dissemination of reference data on marine mammals and health trends of
marine mammal populations in the wild; to correlate the health of
marine mammals and marine mammal populations in the wild with available
data on physical, chemical, and biological environmental parameters;
and to coordinate effective responses to unusual mortality events.
How To Apply
1. Applicants must submit a written request with attached study
plan to the MMHSRP Program Manager, NMFS/Office of Protected Resources
(see ADDRESSES).
2. The following specific information must be included in the
request:
a. A clear and concise statement of the proposed use of the banked
tissue specimen. The applicant must demonstrate that the proposed use
is consistent with the goals of the NMMTB and the MMHSRP.
b. A copy of the applicant's scientific research permit. The
applicant must demonstrate that the proposed use of the banked tissue
is authorized by the permit,
c. Name of principal investigator, official title, and affiliated
research or academic organization;
d. Specific tissue sample and quantity desired;
e. Justification for use of banked tissue;
f. Research facility where analyses will be conducted. The
applicant must demonstrate that the research facility will follow the
Analytical Quality Assurance program, which was designed to ensure the
accuracy, precision, level of detection, and intercompatibility of data
resulting from chemical analyses of marine mammal tissues. Standard
Reference Materials for use in the analysis of marine mammal tissues
can be purchased from the NIST;
g. Estimated date for completion of research, and schedule/date of
subsequent reports;
h. Agreement that all research/findings based on use of the banked
tissue will be reported to the NMMTB and the MMHSRP Program Manager;
and
i. Agreement that credit and acknowledgment will be given to NMFS,
U.S. Geologic Service (USGS), NIST, U.S. Fish and Wildlife Service
(USFWS), the NMMTB, and the collector for use of banked tissues. The
applicant shall insert the following acknowledgment in all
publications, abstracts or presentations based on research using the
banked tissue:
The specimens used in this study were provided by the National
Marine Mammal Tissue Bank, which is maintained in the National
Biomonitoring Specimen Bank at NIST and which is operated under the
direction of NMFS with the collaboration of USGS, USFWS, and NIST
through the Marine Mammal Health and Stranding Response Program [and
the Alaska Marine Mammal Tissue Archival Project if the samples are
from Alaska].
3. Upon submission of a complete application, the MMHSRP Program
Manager will send the request and attached study plan to the following
entities which will function as the review committee:
a. Appropriate Federal agency (NMFS or USFWS) marine mammal
management office for that particular species, and
b. Representatives of the NMMTB Collaborating Agencies (NMFS,
USFWS, USGS Biological Resources Division, and NIST).
If no member of the review committee is an expert in the field that
is related to the proposed research activity, any member may request an
outside review of the proposal, which maybe outside of NMFS or USFWS
but within the federal government.
4. Review committees for requests involving species managed by
Department of the Interior will be chaired by the USFWS Representative
of the NMMTB Collaborating Agencies. All other review committees will
be chaired by the MMHSRP Program Manager.
5. Recommendations on the request and an evaluation of the study
plan will be provided by each committee chair to the Director, Office
of Protected Resources, NMFS.
6. The Director, Office of Protected Resources, NMFS, will make the
final decision on release of the samples based on the advice provided
by the review committee and determination that the proposed use of the
banked tissue
[[Page 68555]]
specimen sample is consistent with the goals of the MMHSRP and the
NMMTB. The Director will send a written decision to the applicant and
send copies to all review committee members. If the samples are
released, the response will indicate whether the samples have been
homogenized and, if not, the homogenization schedule.
7. Shipping and homogenization costs related to the use of any
specimens from the NMMTB will be borne by the applicant.
8. The applicant can keep or dispose of the tissue specimen sample
after the research is completed.
Classification
This proposed rule contains collection-of-information requirements
and, therefore, is subject to the provisions of the Paperwork Reduction
Act (PRA). This requirement has been submitted to OMB for approval.
Public reporting burden for this collection of information is estimated
to average 2 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. Applicants will be submitting a written
request with attached study plan to the MMHSRP to apply for a tissue
specimen sample from the NMMTB. Applicants will also report all
research/findings based on use of the banked tissue to the NMMTB and
the MMHSRP Program Manager.
Public comment is sought regarding: whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; the accuracy of the burden estimate; ways to
enhance the quality, utility, and clarity of the information to be
collected; and ways to minimize the burden of the collection of
information, including through the usti technology. Send comments on
these or any other aspects of the collection of information to the
Office Of Protected Resources at the ADDRESSES above, and to OMB at the
Office of Information and Regulatory Affairs, Office of Management land
Budget, Washington, DC. 20503 (Attention: NOAA Desk Officer).
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.
This action will not have an adverse effect on marine mammals under
the Marine Mammal Protection Act.
This proposed rule does not contain policies with federalism
implications as that term is defined in Executive Order 13132.
This proposed rule has been determined not to be significant for
the purposes of Executive Order 12866.
The Chief Counsel for Regulation at the Department of Commerce
certified to the Chief Counsel for Advocacy of the Small Business
Administration that this proposed rule, if adopted, would not have a
significant economic impact on a substantial number of small entities.
The facts and purpose of this rule appears in the background section of
the preamble and are not repeated here. There are approximately 10,000
that will be eligible to apply for tissue samples under this rule.
These entities include both large and small entities such as
universities, non-profits, small businesses, and individuals. However,
we anticipate that only approximately 10 applicants total will actually
request tissues specimen samples. There is no fee for the sample, but
there is a cost to the applicant of approximately $3.57 (Postage, $.37
plus copying (20 pages x .16) = $3.57). The copying costs would be the
applicant's study plan which they will be submitting. The total for the
ten anticipated applicants is $35.70 ($3.57 x 10 applicants = $35.70).
Because the costs to applicants are minimal, it is concluded that this
rule would not have a significant economic impact on a substantial
number of small entities.
List of Subjects in 50 CFR Part 216
Administrative practice and procedure, Confidential business
information, Fisheries and Marine mammals, Reporting and record keeping
requirements.
Dated: November 4, 2002.
Rebecca Lent,
Deputy Assistant Administrator for Regulatory programs, national Marine
Fisheries Service.
For the reasons set out in the preamble, the National Marine
Fisheries Service (NMFS) proposes to amend 50 CFR part 216 as follows:
PART 216--REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE
MAMMALS
1. The authority citation for part 216 continues to read as
follows:
Authority: 16 U.S.C. 1361 et seq., unless otherwise noted.
2. Section 216.47 is added to read as follows:
Sec. 216.47 Access to marine mammal tissue, analyses, and data.
(a) Applications for the National Marine Mammal Tissue Bank samples
(NMMTB). (1) A principal investigator or holder of a scientific
research permit issued in accordance with the provisions of this
subpart may apply for access to a tissue specimen sample in the NMMTB.
Applicants for tissue specimen samples from the NMMTB must submit a
signed written request with attached study plan to the Marine Mammal
Health and Stranding Response Program (MMHSRP) Program Manager, NMFS/
Office of Protected Resources. The written request must include:
(i) A clear and concise statement of the proposed use of the banked
tissue specimen. The applicant must demonstrate that the proposed use
is consistent with the goals of the NMMTB and the NMHSRP.
(A) The goals of the NMHSRP are to facilitate the collection and
dissemination of reference data on marine mammals and health trends of
marine mammal populations in the wild; to correlate the health of
marine mammals and marine mammal populations in the wild with available
data on physical, chemical, and biological environmental parameters;
and to coordinate effective responses to unusual mortality events.
(B) The goal of the NMMTB is to maintain quality controlled marine
mammal tissues that will permit retrospective analyses to determine
environmental trends of contaminants and other analytes of interest and
that will provide the highest quality samples for analyses using new
and innovative techniques.
(ii) A copy of the applicant's scientific research permit. The
applicant must demonstrate that the proposed use of the banked tissue
is authorized by the permit;
(iii) Name of principal investigator, official title, and
affiliated research or academic organization;
(iv) Specific tissue sample and quantity desired;
(v) Justification for use of banked tissue;
(vi) Research facility where analyses will be conducted. The
applicant must demonstrate that the research facility will follow the
Analytical Quality Assurance program, which was designed to ensure the
accuracy, precision, level of detection, and intercompatibility of data
resulting from chemical analyses of marine mammal tissues;
[[Page 68556]]
(vii) Estimated date for completion of research, and schedule/date
of subsequent reports;
(viii) Agreement that all research findings based on use of the
banked tissue will be reported to the NMMTB and the MMHSRP Program
Manager; and
(ix) Agreement that credit and acknowledgment will be given to
NMFS, US Geologic Service (USGS), National Institute of Standards and
Technology (NIST), U.S. Fish and Wildlife Service (USFWS), the NMMTB,
and the collector for use of banked tissues.
(2) The applicant shall report to the MMHSRP Program Manager all
research findings based on use of the banked tissue in accordance with
the schedule submitted with the application.
(3) The applicant shall insert the following acknowledgment in all
publications, abstracts, or presentations based on research using the
banked tissue:
The specimens used in this study were provided by the National
Marine Mammal Tissue Bank, which is maintained in the National
Biomonitoring Specimen Bank at NIST and which is operated under the
direction of NMFS with the collaboration of USGS, USFWS, and NIST
through the Marine Mammal Health and Stranding Response Program [and
the Alaska Marine Mammal Tissue Archival Project if the samples are
from Alaska].
(4) Upon submission of a complete application, the MMHSRP Program
Manager will send the request and attached study plan to the following
entities which will function as the review committee:
(i) Appropriate Federal agency (NMFS or USFWS) marine mammal
management office for that particular species; and
(ii) Representatives of the NMMTB Collaborating Agencies (NMFS,
USFS, USGS Biological Resources Division, and NIST). If no member of
the review committee is an expert in the field that is related to the
proposed research activity, any member may request an outside review of
the proposal, which maybe outside of NMFS or USFWS but within the
Federal Government.
(5) The Director, Office of Protected Resources, NMFS, will make
the final decision on release of the samples based on the advice
provided by the review committee and determination that the proposed
use of the banked tissue specimen is consistent with the goals of the
MMHSRP and the NMMTB. The Director will send a written decision to the
applicant and send copies to all review committee members.
(6) The applicant will bear all shipping and homogenization costs
related to use of any specimens from the NMMTB.
(7) The applicant can keep or dispose of the tissue specimen sample
consistent with the provisions of the applicant's scientific research
permit after the research is completed.
(b) [Reserved]
[FR Doc. 02-28512 Filed 11-8-02; 8:45 am]
BILLING CODE 3510-22-S