[Code of Federal Regulations]

[Title 50, Volume 7]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 50CFR216.47]



[Page 49-51]

 

                    TITLE 50--WILDLIFE AND FISHERIES

 

  CHAPTER II--NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND 

           ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE

 

PART 216_REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE MAMMALS

--Table of Contents

 

                      Subpart D_Special Exceptions

 

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



[[Page 50]]



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 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



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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]



[69 FR 41979, July 13, 2004]