[Federal Register Volume 69, Number 133 (Tuesday, July 13, 2004)]
[Rules and Regulations]
[Pages 41976-41980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15825]


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DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

50 CFR Part 216

[Docket No. 021017237-4194-02; I.D. 090302F]
RIN 0648-AQ51


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: Final rule.

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SUMMARY: NMFS is issuing a final rule that provides the criteria and 
procedures necessary to access tissue samples archived in the National 
Marine Mammal Tissue Bank (NMMTB). These samples are available to the 
scientific community, contributors, and principal investigators for 
research that is consistent with the goals of the NMMTB and the Marine 
Mammal Health and Stranding Response Program (MMHSRP).

DATES: This final rule is effective August 12, 2004.

[[Page 41977]]


ADDRESSES: Copies of the MMHSRP and the NMMTB Specimen Access Protocol 
can be obtained by writing to Dr. Teri Rowles, Marine Mammal Health and 
Stranding Response Program, MMHSRP, 1315 East West Highway, Silver 
Spring, MD 20910 and can also be obtained from the MMHSRP Web site 
listed under the electronic Access portion of this document.

FOR FURTHER INFORMATION CONTACT: Dr. Teri Rowles, Marine Mammal Health 
and Stranding Response Program, 301-713-2322 ext 178.

SUPPLEMENTARY INFORMATION:

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 http://www.nmfs.noaa.gov/prot_res/PR2/Health_and_Stranding/Response_Program/mmhsrp.html

Background

    On November 12, 2002, NMFS proposed a protocol for access to tissue 
specimen samples from the NMMTB (67 FR 68553). The proposed rule 
provided background information on the availability of tissue specimen 
samples from the NMMTB, which is summarized here. The NMMTB 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 
Hollings 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 or blood from 
specific species; animals from mass strandings; animals that have been 
trapped, injured or killed incidental to commercial fisheries; animals 
taken for subsistence purposes; animals from which biopsies have been 
obtained; and animals from unusual mortality events.
    Each tissue specimen consists of duplicate samples (denoted A and 
B) of approximately 150 g. each. 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. Fifty percent of each specimen is 
available 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.
    Each ``B'' sample of a specimen is divided into three categories. 
Category 1, which is 10 percent of the homogenized material, is 
reserved for baseline analyses. Category 2 consists of 50 percent of 
the material and is reserved for use by specimen contributors. Category 
3 constitutes 40 percent of the material and is available to the 
scientific community for research that is consistent with the goal of 
the NMMTB and the MMHSRP.
    If an ``A'' sample is eventually homogenized, it is divided into 
the following four categories. Category 1 consists of 10 percent of the 
material for baseline analyses. Category 2 consists of 25 percent of 
the material reserved for use by the specimen contributors. Category 3 
consists of 25 percent of the material available to the scientific 
community. Category 4 contains the remaining 40 percent, which is 
intended as a permanent archive. Category 4 will not be used unless a 
very high need can be identified by NOAA and the Department of the 
Interior. Combining the ``A'' and ``B'' samples, the specimen 
allocations for each use are as follows: Category 1 = 10 percent, 
Category 2 = 37.5 percent, Category 3 = 32.5 percent, and Category 4 = 
20 percent.

Comments and Responses and Changes from the Proposed Rule

    NMFS received comments from a variety of sources, including 
representatives of interest groups, state and Federal agencies, 
universities, and private citizens. Comments duplicated others; 
therefore, individual comments were combined and addressed together 
below. Report specific comments were considered and were incorporated, 
as appropriate. There was also a comment received via NMFS' E-comment 
website.
    Comment 1: Four commenters requested that the contributors be 
included in the review process.
    Response: The MMHSRP Program Manager will send the request and 
attached study plan to any contributor(s) of the tissue specimen 
sample. The contributor(s) of the sample may submit comments on the 
proposed research activity to the Director, Office of Protected 
Resources within 30 days of the date that the request was sent to the 
contributor(s).
    Comment 2: All analysis should be reported and made available to 
the contributor(s).
    Response: The research/findings based on use of the banked tissue 
will be reported to the NMMTB, MMHSRP Program Manager, and the 
contributor.
    Comment 3: Credit and acknowledgment should include the original 
collector.
    Response: Applications will be required to include agreement that 
credit and acknowledgment will be given to U.S. Fish and Wildlife 
Service, U.S. Geologic Service, NMFS, National Institute of Standards 
and Technology, Minerals Management Service (MMS), the NMMTB, and the 
collector for use of banked tissue.
    Comment 4: Credit and acknowledgment should include the Minerals 
Management Service.
    Response: This was incorporated into the protocol (see response to 
comment 3).
    Comment 5: Tissue specimen samples used for DNA sequencing should 
be required to archive sequences in the national Center for 
Biotechnology Information's GenBank. Sequence accessions in GenBank 
should document the source, citing a NIST catalog number that 
individually identifies the animal.
    Response: This was incorporated into the protocol.
    Comment 6: Tissue specimen samples should be destroyed after 
research so subsequent research that was not reviewed or approved can 
not be conducted.
    Response: The applicant will dispose of the tissue specimen sample 
after the research is completed unless the requester puts in another 
request for research and receives approval. The timeline for this 
request is three months after the original project has been completed.
    Comment 7: The second paragraph of the Background section was 
misleading when discussing sample ``A'' and ``B''.
    Response: This paragraph was clarified so that it was not 
misleading.
    Comment 8: MMS must be designated as having first priority and 
right of first refusal for access to Alaska Marine Mammal Tissue 
Archival Project (AMMTAP).
    Response: MMS will not have first priority and right of first 
refusal to AMMTAP tissues. MMS will have the same access to tissue 
specimen samples as all other federal agencies that are major partners.
    Comment 9: The second paragraph of the back ground section is 
misleading in that it implies that 50% of the sample ``B'' is available 
to the scientific community for research purposes and 50% of the 
specimen ``A'' is not available. Both ``A'' and ``B'' samples are 
actually divided into categories of various uses. These categories for 
``B''

[[Page 41978]]

sample are: 10% for use by the NMMTB for baseline analysis as part of 
its quality assurance procedures, 60% for use by Federal and non-
Federal Contributors of specimens to the NMMTB, and 40% for use by the 
scientific community (non-contributing). The ``A'' sample is divided 
into 10% for baseline analysis, 25% for Contributors, 25% for 
scientific community, and 40% for long-term archive.
    Response: There is no change, the percentage will stay the same.
    Comment 10: It must be clear in the description on ``How to 
Apply,'' that the procedures described are for the scientific community 
(non-contributors).
    Response: A copy of the applicant's scientific research permit is 
requested in the ``How to Apply'' section. This will clarify that the 
tissue specimen sample will be used for scientific research.
    Comment 11: More streamlined access procedures should be in place 
for contributors, otherwise many important partners may be lost to the 
NMMTB and to the MMHSRP.
    Response: Contributors need to send a proposal for tissue samples 
to the review committee. This level of review is needed to ensure that 
the samples are being used properly.
    Comment 12: The e-comment computer program used to send in comments 
was difficult, cumbersome and user-unfriendly.
    Response: The proposed rule was one of the first rules being used 
for the e-comments program and these problems have been subsequently 
corrected.
    Under 16 U.S.C. 1421f, section 407(d)(1) of the Marine Mammal 
Protection Act (MMPA), NMFS must establish criteria for access to 
marine mammal tissues in the NMMTB and make those criteria available 
for public review and comment, which NMFS made available in the 
proposed rule. In addition, pursuant to MMPA section 407(d) NMFS must 
establish criteria for access to tissue analyses conducted pursuant to 
MMPA section 407(b) and data in the central marine mammal data base 
maintained under MMPA section 407(c). NMFS will establish these 
additional criteria in subsequent rulemaking.
    The criteria require that applicants for tissue specimen samples 
from the NMMTB 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 National Marine Mammal 
Tissue Bank (NMMTB) is to maintain quality controlled marine mammal 
tissues and or blood that will permit retrospective analyses to 
determine such things as environmental trends of contaminants and other 
analytes of interest and that will provide the highest quality samples 
for analyses using new and innovative techniques. The goals of the 
MMHSRP 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.
    How To Apply
    1. Applicants must submit a signed written request with attached 
study plan to the MMHSRP Program Manager, Office of Protected 
Resources, NMFS (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 sample. The applicant must demonstrate that the 
proposed use of the banked tissue is consistent with the goals of the 
NMMTB and the MMHSRP (described above);
    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. Research facility where analyses will be conducted. The 
applicant must demonstrate that the research facility will follow the 
Analytical Quality Assurance (AQA) program, which was designed to 
ensure the accuracy, precision, level of detection, and 
intercompatibility of data resulting from chemical analyses of marine 
mammal tissues. The AQA consists of annual interlaboratory comparisons 
and the development of control materials and standard reference 
materials for marine mammal tissues. Standard Reference Materials for 
use in the analysis of marine mammal tissues can be purchased from the 
NIST;
    f. Verification that funding is available to conduct the research;
    g. Estimated date for completion of research, and schedule/date of 
subsequent reports;
    h. Agreement that all (1)research/findings based on use of the 
banked tissue will be reported to the NMMTB, MMHSRP Program Manager, 
and the contributor; and (2) the sequences of any tissue specimen 
samples that are used/released for genetic analyses (DNA sequencing) 
will be archived in the National Center for Biotechnology Information's 
GenBank. Sequence accessions in GenBank should document the source, 
citing a NIST field number that indentifies the animal; and
    i. Agreement that credit and acknowledgment will be given to U.S. 
Fish and Wildlife Service (USFWS), U.S. Geologic Service (USGS), NMFS, 
NIST, MMS, 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 collected by [the 
contributor] and 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, MMS, 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 may be outside of NMFS or USFWS 
but within the Federal government.
    4. The MMHSRP Program Manager will send the request and attached 
study plan to any contributor(s) of the tissue specimen sample. The 
contributor(s) of the sample may submit comments on the proposed 
research activity to the Director, Office of Protected Resources within 
30 days of the date that the request was sent to the contributor(s).
    5. The USFWS Representative of the NMMTB Collaborating Agencies 
will be chair of the review committees for requests involving species 
managed by the DOI. The MMHSRP Program Manager will be chair of all 
other review committees.

[[Page 41979]]

    6. Each committee chair will provide 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.
    7. 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, comments received from any contributor(s) of 
the sample within the time provided in paragraph 4, and determination 
that the proposed use of the banked tissue 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.
    The average time for review of the request and the mailing of the 
written response to the requester will be 45 working days from receipt 
of the request by the committee chair. However, the Director, Office of 
Protected Resources, NMFS should respond in writing no later than 60 
days following receipt of the letter of request.
    8. Shipping and homogenization costs related to the use of any 
specimens from the NMMTB will be borne by the applicant.
    9. The applicant will dispose of the tissue specimen sample after 
the research is completed unless the requester submits another 
request(within 3 months after the project is complete) and receives 
approval in accordance with the procedures listed above.

Classification

    This final rule contains collection-of-information requirements 
and, therefore, is subject to the provisions of the Paperwork Reduction 
Act (PRA). 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, 
MMHSRP Program Manager, and the contributor.
    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. The OMB approval number for this 
PRA package is OMB 0648 0468.
    This action will not have an adverse effect on marine mammals under 
the Marine Mammal Protection Act.
    This final rule does not contain policies with federalism 
implications as that term is defined in Executive Order 13132.
    This final rule has been determined not to be significant for the 
purposes of Executive Order 12866.
    The Chief Counsel for Regulation of the Department of Commerce 
certified to the Chief Counsel for Advocacy of the Small Business 
Administration that this action, would not have a significant economic 
impact on a substantial number of small entities. The factual basis for 
the certification was published in the proposed rule. No comments were 
received regarding the economic impact of this rule. A final regulatory 
flexibility analysis is not required, and none was prepared.

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: July 7, 2004.
Rebecca Lent,
Deputy Assistant Administrator for Regulatory Programs, National Marine 
Fisheries Service.

0
For the reasons set out in the preamble, 50 CFR part 216 is amended as 
follows:

PART 216--REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE 
MAMMALS

0
1. The authority citation for part 216 continues to read as follows:

    Authority: 16 U.S.C. 1361 et seq., unless otherwise noted.

0
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, contributor 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, 
Office of Protected Resources, NMFS. 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 
of the banked tissue is consistent with the goals of the NMMTB and the 
MMHSRP.
    (A) The goals of the MMHSRP 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) Research facility where analyses will be conducted. The 
applicant must demonstrate that the research facility will follow the 
Analytical Quality Assurance (AQA) program, which was designed to 
ensure the accuracy, precision, level of detection, and 
intercompatibility of data resulting from chemical analyses of marine 
mammal tissues. The AQA consists of annual interlaboratory comparisons 
and the development of control materials and standard reference 
materials for marine mammal tissues;
    (vi) Verification that funding is available to conduct the 
research;
    (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, MMHSRP Program Manager and 
the contributor; and the sequences of tissue specimen samples that are 
used/released for genetic analyses (DNA

[[Page 41980]]

sequencing) will be archived in the National Center for biotechnology 
Information's GenBank. Sequence accessions in GenBank should document 
the source, citing a NIST field number that indentifies the animal; and
    (ix) Agreement that credit and acknowledgment will be given to U.S. 
Fish and Wildlife Service (USFWS), US Geologic Service (USGS), National 
Institute of Standards and Technology (NIST), the Minerals Management 
Service (MMS), NMFS, the NMMTB, and the collector for use of banked 
tissues.
    (2) 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 collected by [the 
contributor] and 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 MMS, 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:
    (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 may be outside of NMFS or USFWS but within the 
Federal Government.
    (4) The MMHSRP Program Manager will send the request and attached 
study plan to any contributor(s) of the tissue specimen sample. The 
contributor(s) of the sample may submit comments on the proposed 
research activity to the Director, Office of Protected Resources within 
30 days of the date that the request was sent to the contributor(s).
    (5) The USFWS Representative of the NMMTB Collaborating Agencies 
will be chair of review committees for requests involving species 
managed by the DOI. The MMHSRP Program Manager will be chair of all 
other review committees.
    (6) Each committee chair will provide recommendations on the 
request and an evaluation of the study plan to the Director, Office of 
Protected Resources, NMFS.
    (7) 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, comments received from any 
contributor(s) of the sample within the time provided in paragraph 
(a)(4) of this section, 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. If the samples are 
released, the response will indicate whether the samples have been 
homogenized and, if not, the homogenization schedule.
    (8) The applicant will bear all shipping and homogenization costs 
related to use of any specimens from the NMMTB.
    (9) The applicant will dispose of the tissue specimen sample 
consistent with the provisions of the applicant's scientific research 
permit after the research is completed, unless the requester submits 
another request and receives approval pursuant to this section. The 
request must be submitted within three months after the original 
project has been completed.
    (b) [Reserved]
[FR Doc. 04-15825 Filed 7-12-04; 8:45 am]
BILLING CODE 3510-22-S