Plant Variety Protection Office, Fee Increase, 40921-40924 [05-13946]
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40921
Proposed Rules
Federal Register
Vol. 70, No. 135
Friday, July 15, 2005
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
Science and Technology (S&T), PVP
Office, NAL Building, Room 401, 10301
Baltimore Avenue, Beltsville, MD
20705–2351, telephone 301–504–5518,
fax 301–504–5291, and e-mail
Janice.Strachan@usda.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Order 12866
DEPARTMENT OF AGRICULTURE
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866, and
therefore, was not reviewed by the
Office of Management and Budget
(OMB).
Agricultural Marketing Service
7 CFR Part 97
[Doc. # ST–05–02]
RIN 0581–AC42
II. Regulatory Flexibility Act
Plant Variety Protection Office, Fee
Increase
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule with request for
comments.
AGENCY:
SUMMARY: The Agricultural Marketing
Service (AMS) proposes to increase
Plant Variety Protection (PVP) Office
application, search, and certificate
issuance fees by 20 percent. The last
general fee increase in February 2003 is
no longer adequate to cover current
program obligations for administrative
and information technology needs. The
PVP Act of 1970 requires that
reasonable fees be collected from
applicants seeking certificates of
protection in order to maintain the
program. Also, a technical amendment
would allow applicants to send voucher
seed samples directly to the public
repository.
Comments must be received on
or before August 15, 2005.
ADDRESSES: Interested persons are
invited to submit comments concerning
this proposed rule. Comments should be
sent in triplicate to Dr. Paul Zankowski,
Commissioner, PVP Office, Room 401,
NAL Building, 10301 Baltimore
Boulevard, Beltsville, MD 20705,
telephone 301–504–5518, fax 301–504–
5291, PVPOmail@usda.gov, and should
refer to the docket title and number
located in the heading of this document.
Comments received will be available for
public inspection at the same location,
between the hours of 10 a.m. and 4 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT:
Janice M. Strachan, USDA, AMS,
DATES:
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Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agricultural
Marketing Service (AMS) has
considered the economic impact of this
action on small business entities. There
are more than 800 users of the PVP’s
variety protection service, of whom
about 100 may file applications in a
given year. Some of these users are
small business entities under the criteria
established by the Small Business
Administration (13 CFR 121.201). The
AMS has determined that this action
would not have a significant economic
impact on a substantial number of these
small business entities.
The Plant Variety Protection (PVP)
Office administers the PVP Act of 1970,
as amended (7 U.S.C. 2321 et seq.), and
issues Certificates of Protection that
provide intellectual property rights to
developers of new varieties of plants. A
Certificate of Protection is awarded to
an owner of a variety after examination
indicates that it is new, distinct from
other varieties, genetically uniform, and
stable through successive generations.
This action will raise the fees charged
to users of plant variety protection. The
AMS estimates that the rule will yield
an additional $277,200 during fiscal
year (FY) 2006. The costs to private and
public business entities will be
proportional to their use of the service,
and shared equitably. The costs to
individual users will increase by
$816.00 per PVP Certificate issued or by
20 percent per application. Plant Variety
Protection is a voluntary service.
AMS regularly reviews its user fee
financed programs to determine if fees
are adequate. The most recent review
determined that the existing fee
schedule will not generate sufficient
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revenue to cover the program’s
operating costs, depleting the trust fund
reserve balance. From 1995 and through
2005, federal salaries have increased 43
percent and inflation has increased the
cost of supplies and services by 25
percent. The net effect on the PVP
Office is an increase in overall expenses
of 41 percent since 1995, offset by fee
increases of 10 percent in September
2000 and 35 percent in February 2003.
The income of the PVP Office is
dependent mainly on the number of
new applications filed, which fluctuated
between 277 and 354 applications since
FY 2000, while typical operating
expenses remain fixed. During this
period, additional funding was needed
for continued technological
improvements and office relocation. In
FY 2001 through FY 2004, expenses
have exceeded income each year,
despite earlier fee increases. Program
operations were maintained by using
the trust fund reserves, thus reducing
those reserves. The PVP Office needs to
adjust fees to provide adequate revenue
for current program operations and to
rebuild an adequate trust fund reserve.
Without a fee increase, FY 2006
revenues are projected at $1,496,000;
costs are projected at $1,614,720 for a
loss of $118,720. The trust fund reserve
would be inadequate to satisfy Agency
policy and prudent financial
management by the end of fiscal year
2007.
AMS calculated the new fee schedule
by projecting FY 2007 revenues of
$1,496,000 and program obligations of
$1,705,662. This indicates a projected
loss to the program of $209,662 for FY
2007. Without a fee increase, the reserve
balance at the end of FY 2007 is
projected to drop to $756,796, which
corresponds to 5 months of operating
funds in the reserve balance. With a fee
increase of 20 percent, FY 2007
revenues are projected to be $1,773,200
and the trust fund reserve balance is
expected to be $1,867,018, which
corresponds to 13 months of operating
funds in the reserve balance. This level
of trust fund maintenance satisfies
Agency requirements.
The proposed action also will amend
regulations related to the voucher seed
sample. The voucher seed sample is a
supplement to the Exhibit C description
of the variety and is kept for the life of
the certificate. Currently, seed samples
are submitted to the PVP Office, which
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Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Proposed Rules
then ships the seed samples to the
public repository at the ARS facility in
Ft. Collins, CO. The proposal will
permit voucher seed samples to be
submitted directly to the public
repository. A small seed sample (15–25
seeds), which may be needed for the
examination of crops which have
distinctive seed characteristics, may be
required for some crops at the discretion
of the examiner. Periodically, the
germination rate of the voucher seed
sample is tested to verify that it remains
a viable sample for long-term storage.
These tests use up the stored seed
sample. A larger initial seed sample is
needed to ensure that germination
testing does not deplete the stored
sample.
A new section will be added to give
stakeholders guidance in how, when,
and where to make the seed deposit.
Because the PVP Office was handling
the seed deposit, these regulations were
deemed unnecessary in the past. Now
that applicants will be depositing seeds
themselves, they will need additional
guidance in how to package the seeds,
where to send them, and when to
deposit them in relation to the filing of
a PVP applicant. This proposed section
is based on similar regulatory language
present in the U.S. Patent and
Trademark Regulations (54 FR 34880,
August 22, 1989, effective January 1,
1990). The patent-related text has been
adapted to fit the specific circumstances
of the PVP Office.
III. Civil Justice Reform
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. This action is not intended to
have retroactive effect, nor will it
preempt any state or local laws,
regulations, or policies, unless they
present an irreconcilable conflict with
the proposed rule. There are no
administrative procedures that must be
exhausted prior to any judicial
challenge to the provisions of the rule.
IV. Paperwork Reduction Act
This rule does not contain any
information collection or record keeping
requirements that are subject to the
Office of Management and Budget
approval under the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35).
Background Information
The PVP Program is a voluntary, user
fee-funded service, conducted under the
Authority of the Plant Variety Protection
Act (7 U.S.C. 2321 et seq.). The Act
authorizes the Secretary of Agriculture
to provide intellectual property rights
that facilitate marketing of new varieties
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of seed-propagated crops and tubers.
The Act also requires that reasonable
fees be collected from the users of the
services to cover the costs of
maintaining the program.
In January 2003, AMS published a
rule in the Federal Register (60 FR
17188) that increased Plant Variety
Protection Office fees and that became
effective February 2003.
In February 2004, the AMS Budget
Office performed a fee analysis that
indicated the need to increase the
program fee schedule in order to recover
the administrative and information
technology costs and maintain an
adequate program reserve balance. For
FY 2006, user fee revenues and program
obligations are projected to be
$1,496,000 and $1,614,720, respectively,
resulting in an estimated $118,720
program deficit. AMS estimates that this
proposed rule would yield an additional
$227,100 during FY 2006 that will offset
increased program operating costs. With
a fee increase, FY 2007 revenues and
expenditures are projected to be
$1,773,200 and $1,705,662, respectively.
AMS used the fees currently charged
as a base for calculating the new fee
schedule for FY 2005. The fees set forth
in Sec. 97.175 as of February 2003
would be increased. The supplemental
fees that were established in May 2005
will not be increased, including the
$250.00 portion of the allowance and
issuance fee that was implemented to
recover the costs of improving the PVP
program’s electronic archiving
capabilities. The application fee will be
increased from $432 to $518, the search
fee from $3,220 to $3,864, and the
original issuance fee from $432 to $518.
The fees for reviving an abandoned
application, correcting or re-issuance of
a certificate are increased from $432 to
$518. The charge for granting an
extension for responding to a request is
increased from $74 to $89. The hourly
charge for any other service not
specified will increase from $89 to $107.
The fee for appeal to the Secretary
(refundable if appeal overturns the
Commissioner’s decision) is increased
from $4,118 to $4,942. Reproduction of
records, drawings, certificates, exhibits
or printed materials, late payment, and
replenishment of seeds will increase by
20 percent. These fee increases are
necessary to recover the costs of this feefunded program.
At the March 2003 annual meeting,
the Plant Variety Protection Advisory
Board was informed of the anticipated
FY 2005 cost increases for maintaining
program operations and administration.
We also consulted with the Board
regarding potential increases to the
basic fee schedule for FY 2005. They
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recommended that fees be increased.
This rule makes the minimum changes
in the regulations to implement the
recommended increased fees to
maintain the program as a fee-funded
program.
The Plant Variety Protection Board
recommended that internal processes
related to the handling of seed samples
be streamlined. Section 97.6(d) was
recently amended to provide that cell
cultures for tuber-reproduced varieties
need not be deposited until after the
examination has been completed, rather
than at the time the application is filed.
A similar change was made for the
establishment of plots of vegetative
material for self-incompatible parents of
hybrids. The requirement that 2,500
seeds of the basic variety must be
submitted while the application was
modified to allow waivers of this
requirement. This proposed rule would
further simplify this process by
applying the same requirements to seeds
and allowing the applicant to submit a
declaration that the seed sample will be
deposited, rather than requiring that the
sample be submitted with the
application. This would increase
efficiencies in the PVP Office by
removing the necessity for the Office to
routinely handle the samples and
forward them to the National Center for
Genetic Resources Preservation
(NCGRP) facility in Ft. Collins,
Colorado. The NCGRP is the only public
depository approved by the
Commissioner at the present time.
We also propose that a larger initial
seed sample be deposited to ensure that
germination testing does not deplete the
stored sample. We propose addition of
Section 97.7, which will provide
guidance to applicants in how, when,
and where to deposit their voucher seed
samples.
A 30-day comment period is provided
to allow interested persons the
opportunity to respond to the proposal,
including any regulatory and
informational impact of this action on
small businesses. Thirty days is deemed
appropriate because present fees are
inadequate to properly cover program
costs and additional revenues need to be
generated to effectively operate the
program.
List of Subjects in 7 CFR Part 97
Plants, Seeds.
For reasons set forth in the preamble,
it is proposed that 7 CFR part 97 be
amended as follows.
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Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Proposed Rules
PART 97—PLANT VARIETY AND
PROTECTION
1. The authority citation for part 97
continues to read as follows:
Authority: 7 U.S.C. 2321 et seq.
2. Section 97.6(d)(1) is revised to read
as follows:
§ 97.6
Application for certificate.
*
*
*
*
*
(d) * * *
(1) A declaration that at least 3,000
seeds of the viable basic seed required
to reproduce the variety will be
deposited in a public depository
approved by the Commissioner and will
be maintained for the duration of the
certificate; or
*
*
*
*
*
3. Section 97.7 is added to read as
follows:
§ 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:
(1) The National Center for Genetic
Resources Preservation, USDA, ARS,
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
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16:12 Jul 14, 2005
Jkt 205001
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
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40923
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;
(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
paragraph (d) of this section.
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
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Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Proposed Rules
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 (c) of this
section.
(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.
4. Section 97.175 is revised to read as
follows:
§ 97.175
Fees and charges.
The following fees and charges apply
to the services and actions specified
below:
(a) Filing the application and
notifying the public of filing—$518.00.
(b) Search or examination—$3,864.00.
(c) Submission of new application
data, after notice of allowance, prior to
issuance of certificate—$432.00.
(d) Allowance and issuance of
certificate and notifying public of
issuance—$768.00.
(e) Revive an abandoned
application—$518.00.
(f) Reproduction of records, drawings,
certificates, exhibits, or printed material
(cost per page of material)—$1.80.
(g) Authentication (each page)—$1.80.
(h) Correcting or re-issuance of a
certificate—$518.00.
(i) Recording an assignment, any
revision of an assignment, or
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16:12 Jul 14, 2005
Jkt 205001
withdrawal or revocation of an
assignment (per certificate or
application)—$41.00.
(j) Copies of 8 x 10 photographs in
color—$41.00.
(k) Additional fee for
reconsideration—$518.00.
(l) Additional fee for late payment—
$41.00.
(m) Fee for handling replenishment
seed sample (applicable only for
certificates issued after June 20, 2005)—
$38.00.
(n) Additional fee for late
replenishment of seed—$41.00.
(o) Filing a petition for protest
proceeding—$4,118.00.
(p) Appeal to Secretary (refundable if
appeal overturns the Commissioner’s
decision)—$4,942.00.
(q) Granting of extensions for
responding to a request—$89.00.
(r) Field inspections by a
representative of the Plant Variety
Protection Office, made at the request of
the applicant, shall be reimbursable in
full (including travel, per diem or
subsistence, and salary) in accordance
with Standardized Government Travel
Regulation.
(s) Any other service not covered
above will be charged for at rates
prescribed by the Commissioner, but in
no event shall they exceed $107.00 per
employee-hour.
Dated: July 11, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 05–13946 Filed 7–14–05; 8:45 am]
BILLING CODE 3410–02–P
because the NRC staff has become aware
of changes in the Technical
Specifications (TS) associated with this
CoC. A notice withdrawing the direct
final rule is published in the final rule
section of this Federal Register.
FOR FURTHER INFORMATION CONTACT:
Jayne M. McCausland, Office of Nuclear
Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555, telephone (301)
415–6219 (e-mail: jmm2@nrc.gov).
SUPPLEMENTARY INFORMATION: On May
25, 2005 (70 FR 30015), the NRC
published in the Federal Register a
proposed rule amending its regulations
in 10 CFR 72.214 to revise the
Standardized NUHOM System listing
within the ‘‘List of Approved Spent Fuel
Storage Casks’’ to include Amendment
No. 8 to the CoC. Amendment No. 8
modifies the present cask system by
adding a new spent fuel storage and
transfer system, designated the
NUHOMS –24PTH System. The NRC
also concurrently published a direct
final rule on May 25, 2005 (70 FR
29931) that would have become
effective on August 8, 2005.
The NRC has become aware of
changes in the TS associated with this
CoC; therefore, the NRC is withdrawing
the proposed rule. The NRC will
publish a direct final rule, and its
companion proposed rule, after the
needed revisions to the TS are made.
Dated at Rockville, Maryland, this 6th day
of July, 2005.
For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. 05–13932 Filed 7–14–05; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 72
NATIONAL CREDIT UNION
ADMINISTRATION
RIN 3150–AH72
List of Approved Spent Fuel Storage
Casks: Standardized NUHOMS –24P,
–52B, –61BT, –32PT, –24PHB, and
–24PTH Revision; Withdrawal of
Proposed Rule
12 CFR Chapter VII
Federal Credit Union Bylaws
AGENCY:
National Credit Union
Administration (NCUA).
ACTION: Notice and request for comment.
SUMMARY: The Nuclear Regulatory
Commission (NRC) is withdrawing a
proposed rule to revise the NUHOMS
–24P, –52B, –61BT, –32PT, –24PHB,
and –24PTH cask system listing within
the list of approved spent fuel storage
casks to include Amendment No. 8 to
Certificate of Compliance (CoC) Number
1004. The NRC is taking this action
SUMMARY: NCUA is proposing changes
to update, clarify and simplify the
Federal Credit Union (FCU) Bylaws.
NCUA proposes these changes because
numerous bylaw amendments approved
by the NCUA Board over the past five
years reveal the need to modify bylaws
or remove provisions that have become
outdated or obsolete.
DATES: Comments must be received by
October 13, 2005.
Nuclear Regulatory
Commission.
ACTION: Proposed rule; withdrawal.
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AGENCY:
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Agencies
[Federal Register Volume 70, Number 135 (Friday, July 15, 2005)]
[Proposed Rules]
[Pages 40921-40924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13946]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 /
Proposed Rules
[[Page 40921]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 97
[Doc. ST-05-02]
RIN 0581-AC42
Plant Variety Protection Office, Fee Increase
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Agricultural Marketing Service (AMS) proposes to increase
Plant Variety Protection (PVP) Office application, search, and
certificate issuance fees by 20 percent. The last general fee increase
in February 2003 is no longer adequate to cover current program
obligations for administrative and information technology needs. The
PVP Act of 1970 requires that reasonable fees be collected from
applicants seeking certificates of protection in order to maintain the
program. Also, a technical amendment would allow applicants to send
voucher seed samples directly to the public repository.
DATES: Comments must be received on or before August 15, 2005.
ADDRESSES: Interested persons are invited to submit comments concerning
this proposed rule. Comments should be sent in triplicate to Dr. Paul
Zankowski, Commissioner, PVP Office, Room 401, NAL Building, 10301
Baltimore Boulevard, Beltsville, MD 20705, telephone 301-504-5518, fax
301-504-5291, PVPOmail@usda.gov, and should refer to the docket title
and number located in the heading of this document. Comments received
will be available for public inspection at the same location, between
the hours of 10 a.m. and 4 p.m., Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT: Janice M. Strachan, USDA, AMS, Science
and Technology (S&T), PVP Office, NAL Building, Room 401, 10301
Baltimore Avenue, Beltsville, MD 20705-2351, telephone 301-504-5518,
fax 301-504-5291, and e-mail Janice.Strachan@usda.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Order 12866
This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866, and therefore, was not reviewed
by the Office of Management and Budget (OMB).
II. Regulatory Flexibility Act
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq.), the Agricultural Marketing Service
(AMS) has considered the economic impact of this action on small
business entities. There are more than 800 users of the PVP's variety
protection service, of whom about 100 may file applications in a given
year. Some of these users are small business entities under the
criteria established by the Small Business Administration (13 CFR
121.201). The AMS has determined that this action would not have a
significant economic impact on a substantial number of these small
business entities.
The Plant Variety Protection (PVP) Office administers the PVP Act
of 1970, as amended (7 U.S.C. 2321 et seq.), and issues Certificates of
Protection that provide intellectual property rights to developers of
new varieties of plants. A Certificate of Protection is awarded to an
owner of a variety after examination indicates that it is new, distinct
from other varieties, genetically uniform, and stable through
successive generations. This action will raise the fees charged to
users of plant variety protection. The AMS estimates that the rule will
yield an additional $277,200 during fiscal year (FY) 2006. The costs to
private and public business entities will be proportional to their use
of the service, and shared equitably. The costs to individual users
will increase by $816.00 per PVP Certificate issued or by 20 percent
per application. Plant Variety Protection is a voluntary service.
AMS regularly reviews its user fee financed programs to determine
if fees are adequate. The most recent review determined that the
existing fee schedule will not generate sufficient revenue to cover the
program's operating costs, depleting the trust fund reserve balance.
From 1995 and through 2005, federal salaries have increased 43 percent
and inflation has increased the cost of supplies and services by 25
percent. The net effect on the PVP Office is an increase in overall
expenses of 41 percent since 1995, offset by fee increases of 10
percent in September 2000 and 35 percent in February 2003. The income
of the PVP Office is dependent mainly on the number of new applications
filed, which fluctuated between 277 and 354 applications since FY 2000,
while typical operating expenses remain fixed. During this period,
additional funding was needed for continued technological improvements
and office relocation. In FY 2001 through FY 2004, expenses have
exceeded income each year, despite earlier fee increases. Program
operations were maintained by using the trust fund reserves, thus
reducing those reserves. The PVP Office needs to adjust fees to provide
adequate revenue for current program operations and to rebuild an
adequate trust fund reserve. Without a fee increase, FY 2006 revenues
are projected at $1,496,000; costs are projected at $1,614,720 for a
loss of $118,720. The trust fund reserve would be inadequate to satisfy
Agency policy and prudent financial management by the end of fiscal
year 2007.
AMS calculated the new fee schedule by projecting FY 2007 revenues
of $1,496,000 and program obligations of $1,705,662. This indicates a
projected loss to the program of $209,662 for FY 2007. Without a fee
increase, the reserve balance at the end of FY 2007 is projected to
drop to $756,796, which corresponds to 5 months of operating funds in
the reserve balance. With a fee increase of 20 percent, FY 2007
revenues are projected to be $1,773,200 and the trust fund reserve
balance is expected to be $1,867,018, which corresponds to 13 months of
operating funds in the reserve balance. This level of trust fund
maintenance satisfies Agency requirements.
The proposed action also will amend regulations related to the
voucher seed sample. The voucher seed sample is a supplement to the
Exhibit C description of the variety and is kept for the life of the
certificate. Currently, seed samples are submitted to the PVP Office,
which
[[Page 40922]]
then ships the seed samples to the public repository at the ARS
facility in Ft. Collins, CO. The proposal will permit voucher seed
samples to be submitted directly to the public repository. A small seed
sample (15-25 seeds), which may be needed for the examination of crops
which have distinctive seed characteristics, may be required for some
crops at the discretion of the examiner. Periodically, the germination
rate of the voucher seed sample is tested to verify that it remains a
viable sample for long-term storage. These tests use up the stored seed
sample. A larger initial seed sample is needed to ensure that
germination testing does not deplete the stored sample.
A new section will be added to give stakeholders guidance in how,
when, and where to make the seed deposit. Because the PVP Office was
handling the seed deposit, these regulations were deemed unnecessary in
the past. Now that applicants will be depositing seeds themselves, they
will need additional guidance in how to package the seeds, where to
send them, and when to deposit them in relation to the filing of a PVP
applicant. This proposed section is based on similar regulatory
language present in the U.S. Patent and Trademark Regulations (54 FR
34880, August 22, 1989, effective January 1, 1990). The patent-related
text has been adapted to fit the specific circumstances of the PVP
Office.
III. Civil Justice Reform
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This action is not intended to have retroactive effect,
nor will it preempt any state or local laws, regulations, or policies,
unless they present an irreconcilable conflict with the proposed rule.
There are no administrative procedures that must be exhausted prior to
any judicial challenge to the provisions of the rule.
IV. Paperwork Reduction Act
This rule does not contain any information collection or record
keeping requirements that are subject to the Office of Management and
Budget approval under the Paperwork Reduction Act of 1995 (44 U.S.C.
Chapter 35).
Background Information
The PVP Program is a voluntary, user fee-funded service, conducted
under the Authority of the Plant Variety Protection Act (7 U.S.C. 2321
et seq.). The Act authorizes the Secretary of Agriculture to provide
intellectual property rights that facilitate marketing of new varieties
of seed-propagated crops and tubers. The Act also requires that
reasonable fees be collected from the users of the services to cover
the costs of maintaining the program.
In January 2003, AMS published a rule in the Federal Register (60
FR 17188) that increased Plant Variety Protection Office fees and that
became effective February 2003.
In February 2004, the AMS Budget Office performed a fee analysis
that indicated the need to increase the program fee schedule in order
to recover the administrative and information technology costs and
maintain an adequate program reserve balance. For FY 2006, user fee
revenues and program obligations are projected to be $1,496,000 and
$1,614,720, respectively, resulting in an estimated $118,720 program
deficit. AMS estimates that this proposed rule would yield an
additional $227,100 during FY 2006 that will offset increased program
operating costs. With a fee increase, FY 2007 revenues and expenditures
are projected to be $1,773,200 and $1,705,662, respectively.
AMS used the fees currently charged as a base for calculating the
new fee schedule for FY 2005. The fees set forth in Sec. 97.175 as of
February 2003 would be increased. The supplemental fees that were
established in May 2005 will not be increased, including the $250.00
portion of the allowance and issuance fee that was implemented to
recover the costs of improving the PVP program's electronic archiving
capabilities. The application fee will be increased from $432 to $518,
the search fee from $3,220 to $3,864, and the original issuance fee
from $432 to $518. The fees for reviving an abandoned application,
correcting or re-issuance of a certificate are increased from $432 to
$518. The charge for granting an extension for responding to a request
is increased from $74 to $89. The hourly charge for any other service
not specified will increase from $89 to $107. The fee for appeal to the
Secretary (refundable if appeal overturns the Commissioner's decision)
is increased from $4,118 to $4,942. Reproduction of records, drawings,
certificates, exhibits or printed materials, late payment, and
replenishment of seeds will increase by 20 percent. These fee increases
are necessary to recover the costs of this fee-funded program.
At the March 2003 annual meeting, the Plant Variety Protection
Advisory Board was informed of the anticipated FY 2005 cost increases
for maintaining program operations and administration. We also
consulted with the Board regarding potential increases to the basic fee
schedule for FY 2005. They recommended that fees be increased. This
rule makes the minimum changes in the regulations to implement the
recommended increased fees to maintain the program as a fee-funded
program.
The Plant Variety Protection Board recommended that internal
processes related to the handling of seed samples be streamlined.
Section 97.6(d) was recently amended to provide that cell cultures for
tuber-reproduced varieties need not be deposited until after the
examination has been completed, rather than at the time the application
is filed. A similar change was made for the establishment of plots of
vegetative material for self-incompatible parents of hybrids. The
requirement that 2,500 seeds of the basic variety must be submitted
while the application was modified to allow waivers of this
requirement. This proposed rule would further simplify this process by
applying the same requirements to seeds and allowing the applicant to
submit a declaration that the seed sample will be deposited, rather
than requiring that the sample be submitted with the application. This
would increase efficiencies in the PVP Office by removing the necessity
for the Office to routinely handle the samples and forward them to the
National Center for Genetic Resources Preservation (NCGRP) facility in
Ft. Collins, Colorado. The NCGRP is the only public depository approved
by the Commissioner at the present time.
We also propose that a larger initial seed sample be deposited to
ensure that germination testing does not deplete the stored sample. We
propose addition of Section 97.7, which will provide guidance to
applicants in how, when, and where to deposit their voucher seed
samples.
A 30-day comment period is provided to allow interested persons the
opportunity to respond to the proposal, including any regulatory and
informational impact of this action on small businesses. Thirty days is
deemed appropriate because present fees are inadequate to properly
cover program costs and additional revenues need to be generated to
effectively operate the program.
List of Subjects in 7 CFR Part 97
Plants, Seeds.
For reasons set forth in the preamble, it is proposed that 7 CFR
part 97 be amended as follows.
[[Page 40923]]
PART 97--PLANT VARIETY AND PROTECTION
1. The authority citation for part 97 continues to read as follows:
Authority: 7 U.S.C. 2321 et seq.
2. Section 97.6(d)(1) is revised to read as follows:
Sec. 97.6 Application for certificate.
* * * * *
(d) * * *
(1) A declaration that at least 3,000 seeds of the viable basic
seed required to reproduce the variety will be deposited in a public
depository approved by the Commissioner and will be maintained for the
duration of the certificate; or
* * * * *
3. Section 97.7 is added to read as follows:
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:
(1) The National Center for Genetic Resources Preservation, USDA,
ARS, 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;
(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 paragraph (d) of
this section. 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
[[Page 40924]]
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 (c) of this section.
(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.
4. Section 97.175 is revised to read as follows:
Sec. 97.175 Fees and charges.
The following fees and charges apply to the services and actions
specified below:
(a) Filing the application and notifying the public of filing--
$518.00.
(b) Search or examination--$3,864.00.
(c) Submission of new application data, after notice of allowance,
prior to issuance of certificate--$432.00.
(d) Allowance and issuance of certificate and notifying public of
issuance--$768.00.
(e) Revive an abandoned application--$518.00.
(f) Reproduction of records, drawings, certificates, exhibits, or
printed material (cost per page of material)--$1.80.
(g) Authentication (each page)--$1.80.
(h) Correcting or re-issuance of a certificate--$518.00.
(i) Recording an assignment, any revision of an assignment, or
withdrawal or revocation of an assignment (per certificate or
application)--$41.00.
(j) Copies of 8 x 10 photographs in color--$41.00.
(k) Additional fee for reconsideration--$518.00.
(l) Additional fee for late payment--$41.00.
(m) Fee for handling replenishment seed sample (applicable only for
certificates issued after June 20, 2005)--$38.00.
(n) Additional fee for late replenishment of seed--$41.00.
(o) Filing a petition for protest proceeding--$4,118.00.
(p) Appeal to Secretary (refundable if appeal overturns the
Commissioner's decision)--$4,942.00.
(q) Granting of extensions for responding to a request--$89.00.
(r) Field inspections by a representative of the Plant Variety
Protection Office, made at the request of the applicant, shall be
reimbursable in full (including travel, per diem or subsistence, and
salary) in accordance with Standardized Government Travel Regulation.
(s) Any other service not covered above will be charged for at
rates prescribed by the Commissioner, but in no event shall they exceed
$107.00 per employee-hour.
Dated: July 11, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 05-13946 Filed 7-14-05; 8:45 am]
BILLING CODE 3410-02-P