[Code of Federal Regulations]
[Title 7, Volume 3]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR97.7]

[Page 255-257]
 
                          TITLE 7--AGRICULTURE
 
 CHAPTER I--AGRICULTURAL MARKETING SERVICE \1\ (STANDARDS, INSPECTIONS, 
       MARKETING PRACTICES), DEPARTMENT OF AGRICULTURE (CONTINUED)
 
PART 97_PLANT VARIETY AND PROTECTION--Table of Contents
 
Sec. 97.7  Deposit of Voucher Specimen.

    (a) Voucher specimen types. As regards the deposit of voucher 
specimen material for purposes of plant variety protection applications 
under 7 U.S.C. 2321 et seq., the term voucher specimen shall include 
material that is capable of self-replication either directly or 
indirectly. Representative examples include seeds, plant tissue cells, 
cell lines, and plots of vegetative material of self-incompatible 
parental lines of hybrids. Seed samples should not be treated with 
chemicals or coatings.
    (b) Need to make a deposit. Applications for plant variety 
protection require deposit of a voucher specimen of the variety. The 
deposit shall be acceptable if made in accordance with these 
regulations. Sample packages shall meet the packaging and deposit 
requirements of the depository. Samples and correspondence about samples 
shall be identified, minimally, by:
    (1) The application number assigned by the Office;
    (2) The crop kind, genus and species, and variety denomination; and
    (3) The name and address of the depositor.
    (c) Acceptable depository. A deposit shall be recognized for the 
purposes of these regulations if made in:

[[Page 256]]

    (1) The National Center for Genetic Resources Preservation, ARS, 
USDA, 1111 South Mason Street, Fort Collins, CO 80521-4500, or
    (2) Any other depository recognized to be suitable by the Office. 
Suitability will be determined by the Commissioner on the basis of the 
administrative and technical competence, and agreement of the depository 
to comply with the terms and conditions applicable to deposits for plant 
variety protection purposes. The Commissioner may seek the advice of 
impartial consultants on the suitability of a depository. The depository 
must:
    (i) Have a continuous existence;
    (ii) Exist independent of the control of the depositor;
    (iii) Possess the staff and facilities sufficient to examine the 
viability and quantity of a deposit, and store the deposit in a manner 
which ensures that it is kept viable and uncontaminated;
    (iv) Provide for sufficient safety measures to minimize the risk of 
losing biological material deposited with it;
    (v) Be impartial and objective;
    (vi) Refrain from distributing samples while the application is 
being examined and during the term of protection but, after control of 
the sample is transferred by the Office to the depository, furnish 
samples of the deposited material in an expeditious and proper manner;
    (vii) Have the capability to destroy samples or return samples to 
the Office when requested by the Office; and
    (viii) Promptly notify the Office of low viability or low quantity 
of the sample.
    (3) A depository seeking status under paragraph (c)(2) of this 
section must direct a communication to the Commissioner which shall:
    (i) Indicate the name and address of the depository to which the 
communication relates;
    (ii) Contain detailed information as to the capacity of the 
depository to comply with the requirements of paragraph (c)(2) of this 
section, including information on its legal status, scientific standing, 
staff, and facilities;
    (iii) Indicate that the depository intends to be available, for the 
purposes of deposit, to any depositor under these same conditions;
    (iv) Where the depository intends to accept for deposit only certain 
kinds of biological material, specify such kinds; and
    (v) Indicate the amount of any fees that the depository will, upon 
acquiring the status of suitable depository under paragraph (c)(2) of 
this section, charge for storage, viability statements and furnishings 
of samples of the deposit.
    (4) A depository having status under paragraph (c)(2) of this 
section limited to certain kinds of biological material may extend such 
status to additional kinds of biological material by directing a 
communication to the Commissioner in accordance with paragraph (c)(3) of 
this section. If a previous communication under paragraph (c)(3) of this 
section is of record, items in common with the previous communication 
may be incorporated by reference.
    (5) Once a depository is recognized to be suitable by the 
Commissioner or has defaulted or discontinued its performance under this 
section, notice thereof will be published in the Official Journal of the 
Plant Variety Protection Office or by other methods typically used for 
dissemination of information related to the procedures of the Office.
    (d) Time of making an original deposit. An original deposit of 
materials for seed-reproduced plants shall be made within three months 
of the filing date of the application or prior to issuance of the 
certificate, whichever occurs first. A waiver may be granted for good 
cause, such as delays in obtaining a phytosanitary certificate for the 
importation of voucher sample materials. When the original deposit is 
made, the applicant must promptly submit a statement from a person in a 
position to corroborate the fact, stating that the voucher specimen 
material which is deposited is the variety specifically identified in 
the application as filed. Such statement must be filed in the 
application and must contain the identifying information listed in 
paragraph (b) of this section and:
    (1) The name and address of the depository;
    (2) The date of deposit;

[[Page 257]]

    (3) The accession number given by the depository; and
    (4) A statement that the deposit is capable of reproduction.
    (e) Replacement or supplement of deposit. If the depository 
possessing a deposit determines either that the sample viability is low 
or that the sample quantity is low, and if this finding is made during 
the pendency of an application or during the term of protection of the 
certificate, the Office shall notify the depositor of the need for 
making a replacement or supplemental deposit. Such deposits will be 
governed by the same considerations governing the need for making an 
original deposit under the provisions set forth in Sec. 97.7(d). 
Notification to the Office concerning deposit of the replacement or 
supplemental sample shall contain a statement from a person in a 
position to corroborate the fact, stating that the replacement or 
supplemental deposit is of a biological material which is identical to 
that originally deposited.
    (f) Term of deposit. A voucher specimen deposit made in support of 
an application for plant variety protection shall be made for a term of 
at least twenty (20) years. In any case, samples must be stored under 
agreements that would make them available to the Office during the 
enforceable life of the certificate for which the deposit was made.
    (g) Viability of deposit. A deposit of biological material that is 
capable of self-replication either directly or indirectly must be viable 
at the time of deposit and during the term of deposit. Viability may be 
tested by the depository periodically. The test must conclude only that 
the deposited material is capable of reproduction. No evidence 
necessarily is required regarding the ability of the deposited material 
to perform any function described in the application. If a viability 
test indicates that the deposit is not viable upon receipt or that the 
quantity of material is insufficient, the examiner shall proceed as if 
no deposit was made. The examiner will accept the conclusion set forth 
in a viability statement issued by a depository recognized under 
paragraph 97.7(c).
    (h) Furnishing of samples. A deposit must be made under conditions 
that assure that:
    (1) Public access to the deposit will not be available during 
pendency of the application or during the term of protection, and
    (2) All restrictions on the availability to the public of the 
deposited material will be irrevocably removed upon the abandonment, 
cancellation, expiration, or withdrawal of the certificate.
    (i) Examination procedures. The examiner shall determine, prior to 
issuance of the certificate, in each application if a voucher sample 
deposit actually made is acceptable for plant variety protection 
purposes.

[70 FR 54611, Sept. 16, 2005]