[Federal Register Volume 85, Number 3 (Monday, January 6, 2020)]
[Rules and Regulations]
[Pages 422-433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27636]
[[Page 422]]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 97
[Document Number AMS-ST-19-0004]
Regulations and Procedures Under the Plant Variety Protection Act
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This final rule revises the regulations, fees for services,
and procedures established under the Plant Variety Protection Act. The
revisions are necessary to conform with recent amendments to the Plant
Variety Protection Act, which added authority for the Plant Variety
Protection Office to issue certificates of protection for varieties of
plants that are reproduced asexually. This rule adds references to the
term ``asexual reproduction'' to the regulations established under the
Plant Variety Protection Act and establishes procedures for obtaining
variety protection for asexually reproduced plant varieties. This rule
also modernizes the regulations by simplifying the fee schedule for
PVPO services and updating the regulations relating to administrative
procedures to reflect current business practices.
DATES: Effective date: January 6, 2020.
Delayed enforcement date: Enforcement of the requirement to deposit
propagating material for asexually reproduced varieties is delayed
until January 6, 2023.
FOR FURTHER INFORMATION CONTACT: Jeffery Haynes, Deputy Commissioner,
Plant Variety Protection Office, AMS Science and Technology Program,
USDA; 1400 Independence Avenue SW, Room 4512-S, Stop 0274, Washington,
DC 20250-0002; telephone: (202) 260-8983; email:
[email protected].
SUPPLEMENTARY INFORMATION: Section 10108 of the Agriculture Improvement
Act of 2018 (Pub. L. 115-334) (2018 Farm Bill) amended the Plant
Variety Protection Act of 1970, as amended (7 U.S.C. 2321-2582) (Act),
by adding a definition for the term ``asexually reproduced'' as it
pertains to plant propagation and adding authority to offer
intellectual property protection to breeders of new varieties of plants
developed through asexual reproduction. The Agricultural Marketing
Service's (AMS) Plant Variety Protection Office (PVPO) processes
applications and grants certificates of protection for plant varieties
under the Act. PVPO also administers the Plant Variety Protection (PVP)
regulations established under the Act at 7 CFR part 97 (regulations).
AMS published a proposed rule in the Federal Register on July 12,
2019 (84 FR 33176). The proposed rule invited comments on proposed
changes to the regulations that correspond with amendments to the Act.
AMS allowed a sixty-day public comment period for interested parties to
submit comments. The comment period ended September 10, 2019. AMS
received six comments on the proposed rule. In anticipation of the
regulatory changes, AMS also sought approval from the Office of
Management and Budget (OMB) for revisions to the information collection
forms PVPO uses to administer the PVP program. AMS announced the forms'
revisions in the Federal Register on May 14, 2019 (84 FR 21314). AMS
received two comments on the forms' revisions during the sixty-day
comment period that ended July 15, 2019. Both submissions also included
comments pertaining to the proposed rule, so AMS also considered those
two comments in the development of this final rule. Based on the
comments received, AMS modified the provisions in the proposed rule
related to required deposits of propagating material with applications
for protection under the Act. The comments and the modifications are
discussed later in this document.
Background Information
The Act authorizes PVPO to provide intellectual property protection
to breeders or owners of new plant varieties to facilitate the
marketing of those new varieties. Currently, owners can apply for and
receive certificates that protect new varieties of seed- and tuber-
propagated plants for 20 years, or 25 years for seed-propagated vines
and trees. A certificate of plant variety protection is granted to the
owner of a variety after examination by PVPO indicates that the variety
is new, distinct from other varieties, genetically uniform, and stable
through successive generations. PVPO-issued certificates are recognized
worldwide and facilitate filing for plant variety protection in other
countries. Certificate owners have the right to exclude others from
marketing and selling protected varieties, manage the use of their
varieties by other breeders, and enjoy legal protection of their work.
Asexually reproduced varieties are those derived using vegetative
material, other than seed, from a single parent, including cuttings,
grafts, tissue cultures, and root divisions. These varieties are a
significant and growing portion of the industry. Developers of
asexually reproduced varieties desire access to the internationally
recognized intellectual property rights that can only be obtained
through PVPO-issued certificates. 2018 Farm Bill amendments to the Act
make that possible.
Provisions
This final rule revises the Plant Variety Protection regulations by
adding references to asexual plant reproduction, as appropriate, to the
regulations that apply to the protection of seed and tubers. Revised
Sec. 97.1 extends the protection breeders can obtain from PVPO to
plants propagated through asexual means. As with other plants covered
by the Act, plant breeders can receive certificates that protect
asexually reproduced plant varieties for 20 years, or 25 years for
trees and vines. Revisions to the definition of the term sale for other
than seed purposes in Sec. 97.2 add ``propagating material'' to that
term as used in the regulations.
Revised Sec. Sec. 97.6 and 97.7 require that except for during a
temporary enforcement delay explained below, applications for plant
variety protection for asexually propagated varieties must be
accompanied by the commitment to deposit propagating material to a
public repository approved by the Commissioner. Such deposits must be
maintained for the duration of the certificate.
Section 97.7(d) specifies that original deposits of propagating
material for seed- and tuber-reproduced plants must be made within
three months of the notice of certificate issuance. Tuber-reproduced
plants are already eligible for plant variety protection under the Act
and regulations. Addition of the reference to tuber-reproduced plants
in Sec. 97.7(d) corrects inadvertent omission of that reference in
previous revisions to the regulations. Section 97.7 also provides for
waiver of the time requirements for making original deposits for good
cause, such as delays in obtaining a phytosanitary certificate for the
importation of propagating material for deposit.
The requirement to make deposits of propagating material to
accompany applications for variety protection under the Act applies to
asexually reproduced varieties on the effective date of this rule.
However, revised Sec. 97.7(d)(3) provides that enforcement of that
requirement is delayed through January 6, 2023. Stakeholder feedback
and comments submitted in response to the proposed rule suggest that it
may sometimes be technically infeasible to deposit or store propagating
material for certain asexually reproduced varieties.
[[Page 423]]
AMS is delaying enforcement of the deposit requirement for asexually
reproduced varieties to give PVPO time to determine the number and type
of deposits that may be technically infeasible at this time. The three-
year delay will also allow PVPO and the industry to identify possible
solutions to technical problems. Although applicants for protection of
asexually reproduced varieties are not required to make original
deposits during the delayed enforcement period, applicants may make the
deposits if they choose.
Revised Sec. 97.7(d)(2) provides that after the delayed
enforcement period, PVP applicants may request and be granted delay
waivers on a case-by-case basis. The revised introductory paragraph of
Sec. 97.7(d) as proposed is further revised to clarify that the
granting of such waivers will be based on the repository's
determination of whether it is feasible to deposit propagating material
for certain asexually reproduced plants. For instance, the repository
may report to PVPO that it is infeasible to store the propagating
material of asexually reproduced grafted trees because of the space
required to do so, or because the repository is unable to prepare or
maintain a viable tissue culture that can be stored for the life of the
protection certificate or grow out true to type upon recovery.
Applicants who obtain delay waivers must agree to maintain the
propagating material at a specific physical location that PVPO could
inspect upon request. Applicants who obtain delay waivers must also
agree to provide propagating material, when it is needed, within three
months of PVPO's request. PVPO will consider a certificate abandoned if
the applicant fails to provide the requested propagating material
within the three-month timeframe. New Sec. 97.7(d)(2)(iii) specifies
that delay waivers are effective until PVPO notifies the applicant that
the technical infeasibility has been resolved. Once so notified, the
applicant must deposit propagating material within three months. If the
applicant fails to make the required deposit, PVPO will consider the
certificate abandoned.
Revised Sec. 97.19(c) replaces the reference to ``name of the kind
of seed,'' which appears on PVPO posts about pending applications, with
the more generic reference to ``name of the crop,'' to accommodate all
types of plant material that can be protected, including asexual
reproduction material. This final rule replaces references to seed
deposits in Sec. 97.104 with references to seed and propagating
material deposits made in the application and certification processes.
Previously, Sec. 97.141 of the regulations allowed owners of plant
varieties for which certificates had been issued to prohibit
unauthorized multiplication of the seed of those varieties. Revised
Sec. 97.141 extends that protection to prohibit the unauthorized
multiplication of propagating material of those varieties. Similarly,
revised Sec. 97.142 allows owners of protected plant varieties to
prohibit unauthorized increases of all propagating material released
for testing or increase. Previously, Sec. 97.142 only specified such
prohibition for seed and reproducible plant material released for
testing or increase.
This final rule modernizes the regulations to reflect current
industry and government practices. The regulations were most recently
revised in 2005 and contained obsolete or incomplete references to
processes that have changed over the years. For instance, when color is
a distinguishing characteristic of a plant variety, the color can be
described according to any recognized color charts used in the industry
for that purpose. Previously, Sec. 97.9 provided one example of a
named color chart--the Nickerson Color Fan, which has long been in use.
This final rule expands the list of examples in Sec. 97.9 to include
two additional examples of color charts that can be referenced, the
Munsell Book of Color and the Royal Horticultural Society Colour Chart,
as well as any other commonly recognized color charts. A further
revision to Sec. 97.9 clarifies that color photos that accompany PVP
applications may be submitted by email, as has been the practice for
several years.
Many of the changes in this final rule pertain to PVPO's
application process, including the timing of different steps in the
process. PVPO expects the changes to simplify the requirements for
applicants and to expedite the issuance of variety protection
certificates, which would benefit their customers. Previously,
applicants paid fees associated with certain steps of the application
process as they went through the process, but revised Sec. 97.6(c)
requires all portions of the application fee--for filing an
application, for application examination by PVPO, and for certificate
issuance--to be paid at the time of application. This final rule makes
corresponding revisions to Sec. Sec. 97.103(a) and 97.104(a) and (c).
Revised Sec. 97.20(a) specifies that, subject to certain exceptions,
filing and examination fees are not refundable after an application is
deemed by PVPO to be abandoned. Revised Sec. 97.23(c) requires payment
of new filing and examination fees for reconsideration of an original
application that has been withdrawn by the applicant. Previously, Sec.
97.101--Notice of Allowance specified that an applicant must pay the
certificate fee within one month of the notice of allowance. Revised
Sec. 97.101 requires the applicant to verify the names of the plant
variety and the owner within 30 days. Under revised Sec. 97.101, the
applicant may opt instead to withdraw the application before the
certificate is issued, in which case the certificate fee portion of the
application fee would be refunded. After the 30 days, an administrative
fee for delayed response will be charged to the applicant or deducted
from the certificate fee refund, if the applicant chooses to withdraw
the application. If the applicant fails to respond at all, the
application will be considered abandoned, and no fees will be refunded.
Revisions to Sec. 97.178 removed references to searches and search
fees and specify that the examination fee may be refunded if an
application is either voluntarily withdrawn or abandoned before the
examination has begun. Section 97.178 is further revised to provide
that the certificate issuance fee will be refunded if an application is
voluntarily withdrawn or abandoned after an examination, but before a
certificate is issued.
This final rule reorganizes and simplifies the schedule of fees and
charges for PVPO services in Sec. 97.175. The revisions consolidate
and simplify the fee schedule to reflect the revisions described above.
Fee amounts for filing an application, examination, certificate
issuance, application reconsideration, revival of abandoned
applications, and filing appeals with the Commissioner or the Secretary
have not been changed from the previous fee schedule. However, flat
fees for PVPO services like reproducing records, authentication, and
correction or reissuance of a certificate are no longer specified
separately in the fee schedule in the regulations and will be charged
at rates prescribed by the Commissioner, not to exceed $97 per employee
hour. Previously those services were estimated to average $107 per
employee hour. Office automation and other process improvements make
the proposed decreases feasible. One such improvement is the ability to
process fee payments through electronic payment systems. Revised Sec.
97.177 specifies that payments can be made through the Plant Variety
Protection system or through pay.gov, although payments by check or
money order will still be allowed.
This final rule replaces obsolete references in the regulations to
the
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Official Journal of the Plant Variety Protection Office with references
to the PVPO website, which is the current business portal used by PVPO
to provide service to its customers. Another revision adds reference to
the PVPO website to the section. Such changes are made to Sec. Sec.
97.5(c), 97.7(c)(5), 97.14(d), 97.19, 97.403(d), and 97.800. Such
changes are also made to what were paragraphs (b) and (d) of Sec.
97.104, but which have been redesignated paragraphs (a) and (c) through
other revisions to the section. Further revised Sec. 97.5(c) provides
that applicants can request forms and information at a PVPO email
address. Revised Sec. 97.12 clarifies that PVPO can use mail or email
to notify applicants of the filing number and effective filing date of
applications received by PVPO. Revised Sec. 97.23(c) specifies that
refiling a voluntarily withdrawn original application must be
accompanied by payment of a new filing and examination fee, while Sec.
97.23(d) has been removed altogether, as it contained obsolete
references to applications pending on April 4, 1995. An additional
revision to the section previously designated Sec. 97.104(b), but now
redesignated Sec. 97.104(a), removes reference to the return of seed
samples deposited with applications, since that is no longer the
practice of PVPO, and provides that samples of seed and propagating
material associated with abandoned applications and certificates will
be retained or destroyed by the repository. This final rule corrects a
reference in Sec. 97.500 to the U.S. Court of Appeals for the Federal
Circuit, to whom applicants may appeal if they are dissatisfied with
decisions of the Secretary related to plant variety protection issues.
Finally, this rule revises the heading for Sec. 97.600 by replacing
the term ``Rules of Practice'' with the term ``Administrative
procedures'' in accordance with Code of Federal Regulations naming
conventions.
Comments
The six comments submitted in response to the proposed rule were
generally supportive of the proposed revisions to the regulations. Some
commenters said they advocated the Farm Bill amendments to the Act.
Commenters recognized the value of the protection obtainable through
PVPO services and welcomed the addition of protection for asexually
reproduced plants particularly, noting that it would give plant
breeders additional options regarding intellectual property protection,
which would in turn spur innovation, benefitting growers and consumers.
Finally, commenters welcomed proposed efforts to modernize the
regulations through technical and administrative changes to the
regulations.
As explained earlier in this document, AMS received two additional
comments during the comment period that were filed in response to a
related notice on proposed revisions to the information collection
forms used in the PVP program. In addition to addressing the
information collection, these submissions included comments and
questions about the proposed rule. The portions of these comments
related to the information collection are addressed in the Paperwork
Reduction Act section below. The portions of these comments related to
the proposed rule are addressed here.
Deposit Requirement
AMS proposed to require that, in conjunction with a PVP
application, a deposit of propagating material be made to a public
repository approved by the Commissioner, and that the deposit be
maintained for the duration of the certificate. As with deposits of
seed and tubers, AMS proposed requiring deposits for asexually
reproduced plants be made within three months after notice of
certificate issuance. To address situations in which it is technically
infeasible to deposit or store propagating materials for certain
asexually reproduced plants, AMS proposed to allow applicants to
request delay waivers that would let them provide a deposit within
three months of a PVPO request when needed. All but two of the comments
addressed the proposed deposit requirement.
Comment: One comment from an industry trade association supported
the proposed deposit requirement, explaining that the industry benefits
from the public availability of germplasm in repositories and that such
deposits can be referred to during dispute settlements. The commenter
also suggested that placing germplasm in public repositories would
alleviate the breeder's burden for maintaining an asexually propagated
variety beyond its commercial lifespan. The commenter assumed that
repository fees for deposits of propagating material would be the same
regardless of the type of protection the breeder is seeking, for
example, a utility patent or a PVP certificate.
AMS Response: AMS agrees that germplasm deposits are useful in
resolving disputes and that maintaining a deposit in a repository would
relieve the breeder's burden for doing so beyond the variety's
commercial lifespan. We believe requiring a deposit also ensures that
upon expiration of the term of protection the propagating material will
be available to interested parties. AMS understands that repository
fees may differ for handling different types of propagating material.
For instance, storing viable seed would probably be much less
complicated than maintaining propagating material for tree or shrub
specimens. We presume that a repository's fees would depend on a
variety of factors, including the services provided, storage logistics,
and duration. We are not aware that the purpose for the deposit would
dictate its cost. Accordingly, this final rule makes no changes to the
proposed rule based on these comments.
Comment: Three comments, including one from an individual, one from
a plant breeders' marketing service, and one representing two
associations of plant breeders, expressed concern about the cost of the
required deposit, as described in the Regulatory Flexibility Analysis
of the proposed rule. Commenters suggested that a $3,000 deposit fee
would be prohibitive for many breeders and could deter them from
seeking protection through the PVP system. Commenters asserted that
other member countries within the International Union for the
Protection of New Varieties of Plants (UPOV) \1\ do not require
breeders to make deposits for asexually reproduced plants, although
they may for seed-propagated varieties, in order to obtain protection.
One commenter suggested that rather than making deposits, applicants be
required to declare where the plant will be maintained during its term
of protection, similar, according to the commenter, to obligations
under Canadian Plant Breeders' Rights.\2\ Commenters believed that the
underlying rationale for AMS's proposed deposit requirement was to
ensure public access to the propagating material after the protection
expires. But commenters argued that plants are commercialized, are
maintained by the breeders, and/or may be part of public collections in
landscapes and botanical gardens, and thus would likely be readily
available to interested parties.
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\1\ International Union for the Protection of New Varieties of
Plants; https://upov.int/portal/index.html.en; accessed 9/23/2019.
\2\ Canadian Food Inspection Agency, Plant Breeders' Rights
Office; https://www.inspection.gc.ca/plants/plant-breeders-rights/eng/1299169386050/1299169455265; accessed 9/20/2019.
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AMS Response: AMS appreciates that paying the repository's fee at
the same time as paying the PVP application fee could seem prohibitive
for some
[[Page 425]]
applicants. Because protection for asexually reproduced plants is new
for PVPO, we can only speculate about how many protection applications
might be submitted and how many applicants would be deterred from
seeking protection under the amended Act because of the deposit cost.
In the regulatory analysis for this rule, we estimated that 50
applicants would apply for protection for asexually reproduced plants
each year. At this time, we don't know how many deposits would be
technically infeasible and eligible for delay waivers.
Accordingly, based on comments and other information, AMS revised
the rule as proposed to provide for delayed enforcement of the deposit
requirement for asexually reproduced variety PVP applications until
January 6, 2023. Applicants are not required to make propagating
material deposits during that period but are required to make
declarations that they will maintain propagating material at a specific
physical location PVPO could inspect and that they will provide
propagating material within three months of PVPO's request. We believe
a delayed enforcement date will allow PVPO to get a feel for the number
and type of deposits that are technically infeasible at this time.
Further, a delayed compliance date would give PVPO time to work with
the industry to identify and resolve feasibility problems. Although it
is not required during the delayed enforcement period, applicants who
choose to do so may submit a deposit of propagating material to the
repository as provided in the regulations.
To date, AMS has identified and approved only one facility that
could serve as a repository for deposits of propagating material for
asexually reproduced plants. Current deposit fees for propagating
material from asexually propagated varieties at that facility are
$3,000 at the time of the deposit and cover preparation of the tissue
culture and maintenance of the deposit for the term of the protection
(20 years for herbaceous plants, 25 years for trees and vines) plus an
additional 10 years beyond the protection's expiration. Thus, over the
total life of the deposit (30 or 35 years), the average annual cost is
minimal. AMS believes the cost to be appropriate and reasonable,
considering the value of the propagating material preserved.
Commenters are correct in that neither other UPOV member countries
nor the U.S. Plant Patent Act require propagating material deposits for
asexually reproduced plants at this time. The Plant Variety Protection
Act requires deposits with PVP applications for seed and tuber-
propagated plants, and PVPO intends to make the application process for
all plant types consistent. Therefore, the final rule requires
applicants to make deposits with PVP applications for asexually
reproduced plants, subject to the delayed enforcement and waiver
provisions discussed above.
As explained in the response to an earlier comment, one of the
reasons for requiring deposits with protection applications is to
ensure that the propagating material will still be available when the
protection expires. Commenters are correct that some protected
varieties may still be publicly or commercially available after the
protection expires, but there is no guarantee that they would. Plants
in public areas may be replaced over time, and the commercial lifespan
of a plant variety may be much shorter than the term of its protection.
Therefore, this final rule continues to require deposits of propagating
material for varieties protected under the Act in PVPO-approved
repositories.
AMS finds merit in the suggestion that protected plant varieties or
their propagating material be maintained by the owner, although we do
not believe it should be the permanent solution to preserving protected
varieties' propagating material. Requiring owners to maintain
propagating material would strengthen the value of protection for
varieties for which PVPO grants delay waivers for technical
infeasibility purposes. Accordingly, based on comments, AMS revised the
rule as proposed to provide that applicants who request delay waivers
due to technical difficulties with depositing propagating materials
must maintain the propagating material at a specific physical location,
subject to PVPO inspection. AMS further revised the delay waiver
provision in the rule as proposed to clarify that the delay waiver is
effective until PVPO notifies the applicant that the technical
infeasibility has been resolved. The applicant will have three months
from notification to make the required deposit. PVPO will consider the
PVP certificate abandoned if the applicant fails to make the required
deposit.
Comment: One comment from an association of plant breeders,
producers, and traders questioned the value of the obligatory deposit
for asexually reproduced plants. The comment stated that the provision
and storage of tissue culture material is complicated and that such
material is prone to mutations. The commenter suggested it might be
more convenient to store a sample of the new plant's DNA instead, which
could be compared to varieties in the market in case of doubt about
their origin.
AMS Response: As we discussed in an earlier comment response, AMS
acknowledges that providing and maintaining tissue cultures is
complicated. The suggestion about storing DNA is interesting, and in
the future, it may be possible to use DNA to satisfy distinctness
tests. But at this time, we cannot reproduce a plant from its DNA
alone. It's essential to preserve propagating material under PVP
certification to ensure a protected plant can be reproduced when
needed. Accordingly, this final rule continues to require PVP
applicants to make propagating material deposits, subject to the
delayed enforcement and waiver provisions described above.
Comment: One comment from an individual noted that the potato
industry has been depositing tissue culture samples with the National
Center for Genetic Resources Preservation (NCGRP) \3\ depository since
1996, when a previous amendment to the Act \4\ allowed tuber propagated
plants to be protected but did not allow for fees to be charged for
deposits. According to the commenter, NCGRP's cost for storing potato
tissue cultures was about $3,200 per deposit. The commenter asked
whether potato breeders would have to pay $3,000 per deposit under the
proposed rule.
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\3\ Agricultural Research Service, USDA. The National Laboratory
for Genetic Resources Preservation (NLGRP) (formerly NCGRP) is
located at the Center for Agricultural Resources Research in Fort
Collins, Colorado. https://www.ars.usda.gov/plains-area/fort-collins-co/center-for-agricultural-resources-research/; accessed 9/
24/2019.
\4\ The Plant Variety Protection Act Amendments of 1994, Public
Law 103-349, October 6, 1994.
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AMS Response: This rule makes no changes to the deposit
requirements for potato varieties. Now known as the National Laboratory
for Genetic Resources Preservation (NLGRP), the repository at a USDA
Agricultural Research Service facility in Fort Collins, Colorado, will
continue to serve as the approved repository for potato tissue
cultures. AMS understands that NLGRP currently charges $2,400 per
application deposit. NLGRP stores the tissue culture for 20 years. The
cost cited earlier for the deposit of material for asexually reproduced
plants is based on a repository that specializes in asexually
reproduced plants and that would prepare the tissue cultures and
provide 30-35 years of storage.
Comment: Aside from concerns about the cost of the deposit
requirement, commenters unanimously supported the proposed delay
waiver, with the
[[Page 426]]
stipulation that propagating material be produced within three months
of PVPO's request. Commenters noted that establishing and maintaining
propagating material in vitro can sometimes be difficult, and that the
waiver option would address technical infeasibilities. One commenter
suggested expanding the proposed waiver option to include waivers for
plants the breeder attests will be placed in the public domain as a
matter of their commercialization.
AMS Response: As discussed earlier, AMS acknowledges there may be
technical difficulties associated with deposits of propagating material
for some asexually reproduced plants. It may be difficult to
successfully preserve tissue cultures of some asexually reproduced
varieties over the long term by cryogenic freezing or other means of
cold storage. The delayed enforcement provision described earlier will
allow PVPO and the industry to explore those issues before enforcing
compliance with the deposit requirement.
As with the unknown longevity of commercialized plant varieties,
there is no way to guarantee that varieties placed in the public domain
will be available for the term of protection under the Act. Thus,
waivers attesting that plant varieties would be placed in the public
domain could not provide adequate assurance. As described in an earlier
comment response, AMS revised the rule as proposed to provide that
applicants who request delay waivers due to technical difficulties with
depositing propagating materials must maintain the propagating material
at a specific physical location, subject to PVPO inspection. AMS
further revised the delay waiver provision in the rule as proposed to
clarify that the delay waiver is effective until PVPO notifies the
applicant that the technical infeasibility has been resolved. The
applicant will have three months from notification to make the required
deposit. PVPO will consider the PVP certificate abandoned if the
applicant fails to make the required deposit. AMS made no further
changes to the rule as proposed based on these comments.
Comment: The commenter representing plant breeder associations
asked AMS to clarify several points regarding the proposed propagating
material deposit. Relaying questions from stakeholders, the commenter
asked how the germplasm deposit system would operate with respect to
germplasm access by other breeders. The commenter also asked whether
other breeders would have access to varieties for comparison purposes.
The commenter asked what rights, if any, the breeder would have over
the deposit, and whether the breeder would be obligated to allow public
access to the deposit at the end of the grant title. Finally, the
commenter asked what rights the PVP office would have to the deposit.
AMS Response: The public does not have access to germplasm deposits
during the life of protection. Breeders must purchase comparison
varieties from the market or request plant material from the owners of
a protected variety. Owners have access to their deposits once they are
placed with the repository. For instance, an owner may need to request
propagating material from the deposit as a backup to their own supply
if it is destroyed or lost. Owners cannot prohibit public access to the
deposit at the end of the protection term. Only varieties for which
protection has expired, or public varieties, are freely available to
the public. PVPO has access to germplasm deposits for examination
purposes and for resolving any disputes about a variety during the term
of protection. AMS is making no changes to the rule as proposed based
on these comments.
Distinctness Requirement
Currently, to obtain variety protection under the Act, applicants
must submit, among other things, a complete description of the
candidate plant's origin and breeding history. The applicant must
describe the characteristics by which the new plant can be
distinguished from its parents. The applicant must also supply a
statement of uniformity reporting the level of variability in any
characteristics of the new variety. And finally, the applicant must
show that the new plant's characteristics are stable within its
progeny. Collectively, this information is known in the industry as a
Distinctness, Uniformity, and Stability (DUS) report. In response to
AMS's proposal to extend variety protection to asexually reproduced
plant varieties, two comments from trade associations and one comment
from a research university's technology and licensing program posed
several technical questions about the variety examination process,
including use of DUS reports and other requirements.
Comment: Two commenters asked whether PVPO would adopt the UPOV
Technical Guidelines \5\ related to distinctness for each crop. All
three commenters advocated PVPO acceptance of UPOV DUS examination
reports in lieu of some standard PVPO application requirements to
reduce duplication of work and cost breeders have already expended to
obtain variety protection in other countries. One commenter advocated
establishing a set of minimum requirements for each crop to enable PVPO
to compare varieties from different applicants. One of the commenters,
assuming UPOV requirements would be used until PVPO could update one of
its application forms to accommodate asexually reproduced plants, asked
whether the UPOV requirements would remain in place permanently or be
replaced by PVPO forms. One commenter suggested technical
questionnaires for PVP applications should follow UPOV questionnaires
and not be overly detailed.
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\5\ Commenters refer to UPOV Technical Guidelines, but AMS
assumes they mean the UPOV Test Guidelines, as shown at: https://www.upov.int/test_guidelines/en/; accessed 9/23/2019.
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AMS Response: PVPO is a member of UPOV, which is the international
convention for plant variety protection. UPOV standards are agreed upon
by its 88 country members. As a member, PVPO recognizes and employs
many UPOV protocols where they are consistent with the statutory
requirements of the Act. As explained in the Paperwork Reduction Act
section of this document, AMS, in conjunction with revising the
regulations to provide for protection of asexually reproduced plant
varieties, revised the package of forms used in the PVP program. The
Table of Characteristics for each crop in UPOV's Test Guidelines is
included in the crop specific Exhibit C form of the PVP application.
Consistent with the Table of Characteristics' asterisked (prioritized)
characteristics,\6\ PVPO considers those characteristics minimum
requirements in the PVP application. Because PVPO has already updated
its application forms, there is no need to temporarily rely on UPOV
requirements or to provide for a transition period before applying the
PVP requirements established in this rule.
---------------------------------------------------------------------------
\6\ Asterisked characteristics (denoted by *) are those included
in the UPOV Test Guidelines which are important for the
international harmonization of variety descriptions and should
always be examined for DUS and included in the variety description
by all members of the Union, except in certain circumstances.
---------------------------------------------------------------------------
PVPO will consider accepting DUS reports applicants have used to
obtain variety protection in other countries on a case-by-case basis.
The UPOV Test Guidelines are instructions used by each UPOV member
country, including the United States, to create their own DUS report
that references the Table of Characteristics. The applicant must work
with PVPO to determine whether
[[Page 427]]
the applicant's country's report provides the information necessary to
approve a PVP application. PVPO collects only that information
necessary to establish whether a new plant is distinct from other
plants. PVPO's examination process, including the questionnaire,
incorporates only those questions necessary to provide variety
protection under the Act and reflects the UPOV questionnaire. The
questionnaire may evolve over time as the industry and PVPO gain
experience examining applications for variety protection for asexually
propagated plants. Accordingly, AMS is making no changes to the rule as
proposed based on these comments at this time.
Comment: Commenters asked whether PVPO would continue to recognize
breeder-conducted testing and breeders' variety descriptions. One
commenter also encouraged PVPO to continue providing and publishing
detailed breeding histories included in applications because the
commenter believes the histories are useful to other breeders, and
along with other elements of the PVP application, make its protection
one of the world's strongest.
AMS Response: AMS will continue to recognize breeder-conducted
testing and breeders' variety descriptions. AMS agrees that providing
detailed breeding histories is helpful to other breeders and will
continue to publish breeding histories included in PVP applications
once the new variety is issued a certificate of protection. Breeding
histories are published on the PVPO website. Accordingly, AMS is making
no changes to the rule as proposed based on these comments.
Fee Structure
PVPO fees are established in the regulations and are published on
its website.\7\ The current total cost for variety protection is
$5,150, including separate fees for distinct steps of the application
and certification process. PVPO also charges for additional services,
such as reviving abandoned applications or reproducing records.
Currently, applicants pay fees associated with distinct steps of the
application process in advance, as they go along. Charges for other
services, including clerical work, are payable when the services are
requested.
---------------------------------------------------------------------------
\7\ https://www.ams.usda.gov/services/plant-variety-protection/pvpo-services-and-fees.
---------------------------------------------------------------------------
The proposed rule included a revised fee structure that would
consolidate all the fees for the application and certification process
into one payment due in advance at the time of application. AMS
proposed no changes to the total cost of application and certification,
nor to the rates for individual elements of the application process.
AMS proposed changing the fee structure for certain additional services
by eliminating flat fees for those services and reducing the effective
hourly rate charged. Two comments addressed the proposed revisions to
the fee structure.
Comment: Both comments from trade associations pointed out that
variety protection offered by PVPO is more costly than that available
from the U.S. Patent Office. Commenters speculated that costs would
impact small businesses particularly and could deter many from using
PVPO services. Both commenters suggested AMS consider implementing a
tiered system that would adjust fees for small businesses and
individuals.
AMS Response: PVPO acknowledges the cost of obtaining a PVP
certificate is more costly than obtaining a plant patent from the U.S.
Patent Office. The PVP program is funded by user fees. PVPO fees are
based on the actual cost of providing services, including examinations,
office expenses, and agency overhead. Fees are the same for all
applicants. AMS does not believe it would be appropriate or practical
to introduce a tiered pricing system based on business size. AMS
proposed to consolidate the application and certification fees into one
up-front charge because PVPO has considerably reduced the time it takes
to approve a PVP application over the years. Whereas the process used
to take up to five years, PVP can now complete the work in as little as
18 months. Thus, the waiting period between each step of the process is
much shorter. Requiring full payment up front is expected to further
streamline the application and certification process by eliminating the
need to contact applicants and wait for payments before progressing to
the next step. Collecting the fee up front reduces administrative
expense and allows PVPO to continue providing faster service at the
same, or in some cases lower, cost. Thus, AMS is making no changes to
the rule as proposed based on these comments.
Miscellaneous Comments
Three comments made suggestions or requested clarification about
PVP regulations.
Comment: One comment from an individual suggested that labels on
asexually propagated plants should include information about how the
plant was propagated.
AMS Response: The Act and PVP regulations allow for labeling of a
protected variety, but there is no statutory requirement to provide
specific information. PVP labeling regulations only specify the
terminology that may be used on plant labels for which the owners have
applied for or obtained U.S. variety protection under the Act. Under
the regulations, labels may contain other information that is not false
or misleading. See Sec. Sec. 97.140 to 97.144. Accordingly, AMS is
making no changes to the rule as proposed based on this comment.
Comment: One comment from a trade association stated that the
regulations are vague regarding the grace period during which breeders
can file for PVP after a plant has been commercialized outside the
United States. Additionally, the commenter believes there is some
ambiguity in the regulations about how the grace period for trees and
vines will be applied and suggested that a six-year grace period should
be applied to woody plants.
AMS Response: The PVP regulations do not specify the grace period
between the dates of commercialization and application for protection
under the Act. PVPO references the Act to determine whether a plant can
be considered ``new'' and eligible for PVP protection. See 7 U.S.C.
2402. A breeder who commercializes a new tree or vine outside the U.S.
has up to six years to apply for variety protection under the Act. Once
a new tree or vine is commercialized in the U.S., the breeder has only
one year to apply for variety protection under the Act. To date, PVPO
has not received applications for trees or vines, which are usually
propagated asexually, and has not had to consider whether a plant is a
tree or vine and subject to the Act's timeframes for those types of
plants. Nevertheless, PVPO refers to USDA's Natural Resources
Conservation Service definitions \8\ for tree and vine to determine
whether a plant is a tree or vine for eligibility purposes. Thus, PVPO
considers vines to be twining or climbing woody plants with relatively
long stems. PVPO considers trees to be perennial, woody plants with a
single stem (trunk), normally greater than 4 to 5 meters (13 to 16
feet) in height. Under certain circumstances, some tree species may
develop a multi-stemmed or short growth form (less than 4 meters or 13
feet in height). AMS is making no changes to the rule as proposed based
on this comment.
---------------------------------------------------------------------------
\8\ USDA, Natural Resources Conservation Service; https://plants.usda.gov/growth_habits_def.html; accessed 9/25/2019.
---------------------------------------------------------------------------
Comment: One comment from a trade association questioned a
reference in the
[[Page 428]]
proposed rule to a change to Sec. 97.104(a) regarding the disposition
of seed deposits of abandoned applications.
AMS Response: The commenter is correct in that the proposed change
applied to the existing Sec. 97.104(b), which was proposed elsewhere
in the proposed rule to be redesignated Sec. 97.104(a). We have
clarified that in the preamble discussion, but AMS made no change to
the rule as proposed based on this comment.
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. The affected industry falls under the North American
Industry Classification System (NAICS) as code 54171--Research and
development in the physical, engineering, and life sciences. This
classification includes firms that are not plant breeders/plant
research; however no detailed industry data was available for the
analysis.
Table 1 shows the most recent descriptive data for the industry,
obtained from the County Business Pattern 2016 survey. This data set
provides information on the number of establishments, number of
employees, and total annual payroll.
Table 1--Number of Establishments, Revenue and Payroll by Employee Count, NAICS Code 54171, 2016 County Business
Patterns \9\
----------------------------------------------------------------------------------------------------------------
Number of Number of paid Annual payroll
establishments employees ($1,000)
----------------------------------------------------------------------------------------------------------------
All Establishments..................................... 17,292 695,810 $82,865,611
----------------------------------------------------------------------------------------------------------------
The Small Business Administration (SBA) determines firm size for
this industry by number of employees, but on a per firm basis, with
small firms defined as having fewer than 1,000 employees and 1,000 or
more employees per firm classified as large. Because firms may own more
than one establishment, and the County Business Patterns data are
compiled on an establishment rather than a firm basis, we must use the
Economic Census data to determine the number of small and large firms
for the industry.
---------------------------------------------------------------------------
\9\ Geography Area Series: County Business Patterns by
Employment Size Class, 2016 Business Patterns, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=BP_2016_00A3&prodType=table.
---------------------------------------------------------------------------
Table 2 shows the most recent data available on the breakdown
between small (<1,000 employees) and large (1,000 or more employees)
firms in this industry, according to the SBA's guidance.\10\ The data
are from the 2002 Economic Census, with monetary values converted to
2016 dollars. More recent Economic Census data is not available at this
level of detail for this industry.
---------------------------------------------------------------------------
\10\ ``Table of Small Business Size Standards Matched to North
American Industry Classification System Codes'', Small Business
Administration, effective January 1, 2017, https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
Table 2--Number of Firms and Establishments, Revenue and Payroll by Employee Count, NAICS Code 54171, 2002
Economic Census \11\
----------------------------------------------------------------------------------------------------------------
Number of Annual
Size of firm by number of Number of Number of paid Revenue * payroll *
employees firms establishments employees ($1,000) ($1,000)
----------------------------------------------------------------------------------------------------------------
Small--Firms with fewer than 10,200 11,753 273,601 $49,702,793 $24,780,487
1,000 employees..............
Large--Firms with 1,000 79 1,380 283,816 30,095,258 27,776,903
employees or more............
All firms..................... 10,279 13,133 557,417 79,798,051 52,557,389
----------------------------------------------------------------------------------------------------------------
* Adjusted to 2016 values.
The 2002 Economic Census reported that fewer than one percent of
firms were considered large (79 of 10,279 firms, or 0.54 percent). The
10,279 firms at that time owned a total of 13,133 establishments, with
1,380 (nearly 11 percent) of these facilities owned by the 79 large
firms.
---------------------------------------------------------------------------
\11\ Professional, Scientific, and Technical Services: Subject
Series--Establishment and Firm Size: Employment Size of Firms for
the United States: 2002 Economic Census of the United States,
https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2002_US_54SSSZ5&prodType=table.
---------------------------------------------------------------------------
The tables show the extent of growth in the industry over time. The
number of establishments has grown from 13,133 in 2002 to 17,292 in
2016 (32 percent, or 2.3 percent per year). Total employment increased
from 557,417 workers to 695,810 (25 percent, or 1.8 percent per year),
and total annual payroll increased from $52,557,389 to $82,865,611 (58
percent, or 4 percent per year). These figures indicate that the
industry has seen small to moderate growth, with a more highly paid
work force over time. There do not appear to have been significant
changes in the structure of the industry between 2002 and 2016.
In reviewing PVPO's list of customers, AMS found evidence that the
size distribution of the firms affected by this rule was consistent
with data reported in the 2002 Economic Census. AMS estimates that most
PVPO customers would be considered small business entities under the
criteria established by SBA (13 CFR 121.201), while fewer than 5% of
the plant breeders and plant research and development firms using PVPO
services would be considered large businesses with 1,000 or more
employees.
The PVP Office administers the PVP Act of 1970, as amended (7
U.S.C. 2321 et seq.), and issues certificates of plant variety
protection that provide intellectual property rights to developers of
new varieties of plants. A certificate is awarded to the owner of a
variety after examination indicates that it is new, distinct from other
varieties, genetically uniform, and stable through successive
generations. PVP is a voluntary service.
This final rule amends the regulations to add application and
certification procedures for asexually reproduced
[[Page 429]]
plants that mirror procedures currently in use for sexually reproduced
and tuber propagated varieties. This final rule is intended to give
breeders of new plant varieties additional tools for protecting new and
emerging crops that were not previously available. This benefit will
accrue to breeders of all sizes. As well, this final rule simplifies
the fee schedule for services provided by the PVPO and reduces maximum
chargeable fees for some services from $107.00 per hour to $97.00 per
hour. The new fee schedule and rates will streamline the certification
process and reduce the cost of maintaining a PVP certificate of plant
variety protection and will apply to applicants of all sizes. Finally,
the modernization of business processes under the regulations is
intended to improve service delivery to PVPO customers of all sizes.
There are currently more than 800 users of the plant variety protection
service, of whom about 95 file applications in a given year. Some of
these users are small business entities under the criteria established
by SBA (13 CFR 121.201). With this action, the number of users is
expected to increase by roughly 40 firms. AMS expects the industry to
submit an additional 50 new applications on a yearly basis.
PVP applicants are subject to an application fee of $5,150 per
certificate. This final rule allows firms that withdraw their
applications to be reimbursed $3,864 prior to examination, and $768
prior to issuing a PVP certificate. Additional services are available
from the PVPO at the request of the applicant. Applicants using these
services are subject to fees as listed in the rule schedule (7 CFR
97.175), with the inclusion of the reduction in fees for specified
services. It is expected that new applicants will also participate in
the germplasm deposit, at a cost of $3,000 per deposit, after the
delayed enforcement period, which ends January 6, 2023.
The burden on new entrants is calculated by multiplying the cost of
application, $5,150, by the number of expected new applications (50),
for an additional cost of $5,150 x 50 = $257,500. The cost to new
entrants for the germplasm deposit after January 6, 2023, is $3,000 x
50 = $150,000. In total this represents an additional cost to industry
for this proposed rule of $407,500. The estimate is an upper boundary
made without including the cost savings that result from deposit
waivers, the reduced hourly fee for additional services, or the
reimbursement for withdrawn applications, as these cost reductions are
expected to be needed infrequently.
Due to the limited cost of the final rule expanding a voluntary
program, AMS has determined that this action will not have a
significant economic impact on a substantial number of these small
business entities.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
Chapter 35), AMS submitted the information collection requirements for
this program as a new collection to OMB for approval. AMS developed a
new PVP application form for asexually reproduced plant varieties. AMS
estimated a total annual reporting burden of 553 hours associated with
the new form, based on an estimated 50 respondents (the number of
additional applications) making approximately 12.82 responses averaging
0.86 hours per response.
On May 14, 2019, AMS published a notice concerning the request for
OMB approval of the new form and solicited comments on the new
information collection and estimated burden (84 FR 21314). The notice
provided a 60-day comment period to allow interested parties to submit
comments on the approval request. AMS received two comments. Both
included comments on certain aspects of the concurrent proposed rule as
well as comments on the information collection. AMS addressed comments
on the proposed rule in the Comments section of this document above,
and addresses comments on the information collection here.
Comment: One comment from a university technology and licensing
program recommended that PVPO employ online technical questionnaires to
collect crop-specific information. According to the commenter, UPOV
uses such questionnaires, which the commenter believes are more
practical and less burdensome to file and would harmonize the ST-470
series of forms with similar DUS forms used in other countries.
AMS Response: PVPO incorporated the UPOV Test Guidelines into its
forms related to asexually reproduced crops in order to harmonize with
the UPOV system. The PVPO still requires the use of Form ST-470 and
related exhibits, since the U.S. PVP system is breeder-based. Under
PVP, the breeder performs the two required grow-out trials and provides
the characteristics data from those trials on the crop-specific Exhibit
C form, which incorporates the UPOV Table of Characteristics. Form ST-
470 and its exhibits provide PVPO with information needed by the
examination staff in the absence of PVPO-controlled grow-out trials.
Accordingly, AMS made no changes to the approved forms based on this
comment.
Comment: One comment from an association of plant breeders,
producers, and traders supported replacing Form ST-470-C (Exhibit C--
Objective Description of Variety) with an approved DUS report from a
UPOV member state. The commenter also supported merging Forms ST-470-A,
-B, and -E (Exhibits A, B, and E) into one form for the PVPO
information collection, although they did not explain why. Finally, the
commenter asserted that the information collected on Form ST-470-A
(Exhibit A--Origin and Breeding History) is not necessary for all plant
species because plant pedigree information is irrelevant to the variety
description. The commenter believes requiring such information is
administratively burdensome and breaches business confidentiality.
AMS Response: PVPO will accept DUS reports from other UPOV
countries on a case-by-case basis for all asexually reproduced
varieties and several sexually propagated varieties. The information
applicants provide on Form ST-470-A (Exhibit A--Origin and Breeding
History) demonstrates to PVPO examiners that a variety has been further
developed beyond just discovery of a new variety. AMS believes the
information requested does not differ in principle from the questions
asked on the UPOV Technical Questionnaire regarding breeding type and
history. AMS believes the information collected on Form ST-470 and its
exhibits allows PVPO to complete a full examination of a new variety
for distinctness, uniformity, and stability. Accordingly, AMS made no
changes to the new information collection in response to the comments.
OMB approved the new information collection and the new application
form, which will be merged with PVPO's existing information package,
OMB No. 0581-0055.
This final rule revises the PVP regulations to allow PVPO to issue
certificates of protection for asexually reproduced plant varieties.
This final rule also simplifies the fee schedule for applicants and
will lower the fees for some services. Finally, this rule modernizes
the PVPO regulations to reflect current industry and government
business operations. Reports and forms used in PVPO operations are
periodically reviewed to reduce information requirements and
duplication by industry and public sector agencies.
[[Page 430]]
E-Government Act
AMS is committed to complying with the E-Government Act to promote
the use of the internet and other information technologies, to provide
increased opportunities for citizen access to Government information
and services, and for other purposes.
Executive Orders 12866 and 13771
This final rule does not meet the definition of a significant
regulatory action contained in section 3(f) of Executive Order 12866
and is not subject to review by the Office of Management and Budget
(OMB). Additionally, because this proposed rule does not meet the
definition of a significant regulatory action, it does not trigger the
requirements contained in Executive Order 13771. See OMB's Memorandum
titled ``Interim Guidance Implementing Section 2 of the Executive Order
of January 30, 2017, titled `Reducing Regulation and Controlling
Costs''' (February 2, 2017).
Executive Order 13175
This final rule has been reviewed under Executive Order 13175--
Consultation and Coordination with Indian Tribal Governments. Executive
Order 13175 requires Federal agencies to consult and coordinate with
tribes on a government-to-government basis on: (1) Policies that have
tribal implication, including regulation, legislative comments, or
proposed legislation; and (2) other policy statements or actions that
have substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes.
AMS has assessed the impact of this rule on Indian tribes and
determined that this rule will not have tribal implications that
require consultation under Executive Order 13175. AMS hosts a quarterly
teleconference with tribal leaders where matters of mutual interest
regarding the marketing of agricultural products are discussed.
Information about changes to the regulations were shared during one
such quarterly call, and tribal leaders were informed about the
revisions to the regulations and invited to ask questions and share
concerns. AMS will work with the USDA Office of Tribal Relations to
ensure meaningful consultation is provided as needed with regards to
the PVPO regulations.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule as defined by 5 U.S.C. 804(2).
Executive Order 12988
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 rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 63 of the Act,
when an application for plant variety protection has been refused by
the PVPO, the applicant may appeal to the Secretary. The Secretary must
seek the advice of the Plant Variety Protection Board on all appeals
before deciding an appeal. The Act provides that an applicant can
appeal the Secretary's decision in the U.S. Court of Appeals for the
Federal Circuit or institute a civil action in the U.S. District Court
for the District of Columbia, provided that such action is taken within
60 days of the Secretary's decision, or such further time as the
Secretary allows.
List of Subjects in 7 CFR Part 97
Plants, seeds.
For the reasons set forth in the preamble, USDA amends 7 CFR part
97 as follows:
PART 97--PLANT VARIETY AND PROTECTION
0
1. The authority citation for part 97 continues to read as follows:
Authority: Plant Variety Protection Act, as amended, 7 U.S.C.
2321 et seq.
0
2. Revise Sec. 97.1 to read as follows:
Sec. 97.1 General.
Certificates of protection are issued by the Plant Variety
Protection office for new, distinct, uniform, and stable varieties of
sexually reproduced, tuber propagated, or asexually reproduced plants.
Each certificate of plant variety protection certifies that the breeder
has the right, during the term of the protection, to prevent others
from selling the variety, offering it for sale, reproducing it,
importing or exporting it, conditioning it, stocking it, or using it in
producing a hybrid or different variety from it, as provided by the
Act.
0
3. Amend Sec. 97.2 by removing the definition for ``Official Journal''
and revising the definition for ``Sale for other than seed purposes''.
The revision reads as follows:
Sec. 97.2 Meaning of words.
* * * * *
Sale for other than seed or propagating purposes. The transfer of
title to and possession of the seed or propagating material by the
owner to a grower or other person, for reproduction for the owner, for
testing, or for experimental use, and not for commercial sale of the
seed, reproduced seed, propagating material, or reproduced propagating
material for planting purposes.
0
4. Amend Sec. 97.5 by revising paragraph (c) to read as follows:
Sec. 97.5 General requirements.
* * * * *
(c) Application and exhibit forms shall be issued by the
Commissioner. (Copies of the forms may be obtained from the Plant
Variety Protection Office by sending an email request to
[email protected] or downloading forms from the PVPO website (https://www.ams.usda.gov/PVPO).
* * * * *
0
5. Amend Sec. 97.6 by revising paragraphs (c) and (d)(3) and adding
paragraph (d)(4) to read as follows:
Sec. 97.6 Application for certificate.
* * * * *
(c) The fees for filing an application, examination, and
certificate issuance shall be submitted with the application in
accordance with Sec. Sec. 97.175 through 97.178.
(d) * * *
(3) With the application for a hybrid from self-incompatible
parents, a declaration that a plot of vegetative material for each
parent will be established in a public depository approved by the
Commissioner and will be maintained for the duration of the
certificate, or
(4) Except as provided in Sec. 97.7(d)(3), with the application
for an asexually propagated variety, a declaration that a deposit of
propagating material in a public depository approved by the
Commissioner will be made and maintained for the duration of the
certificate.
0
6. Amend Sec. 97.7 by revising the first sentence of paragraph (b)
introductory text and paragraphs (c)(5) and (d) to read as follows:
Sec. 97.7 Deposit of Voucher Specimen.
* * * * *
(b) Need to make a deposit. Except as provided in (d)(3),
applications for plant variety protection require deposit of a voucher
specimen of the variety. * * *
* * * * *
(c) * * *
[[Page 431]]
(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 on the Plant Variety
Protection Office website (https://www.ams.usda.gov/PVPO).
(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. An original deposit of materials
for tuber-propagated plants or asexually reproduced plants shall be
made within three months from the notice of certificate issuance date.
A waiver from these time requirements may be granted for good cause,
such as delays in obtaining a phytosanitary certificate for the
importation of voucher sample materials. A delay waiver may also be
granted if the repository determines that it is technically infeasible
to deposit propagating materials for certain asexually reproduced
plants.
(1) 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:
(i) The name and address of the depository;
(ii) The date of deposit;
(iii) The accession number given by the depository; and
(iv) A statement that the deposit is capable of reproduction.
(2) The following conditions apply to delay waivers granted due to
technical difficulties with depositing propagating material for
asexually reproduced plants:
(i) The applicant is required to make a declaration that the
propagating material will be maintained at a specific physical
location, subject to Plant Variety Protection Office inspection when
requested; and
(ii) The applicant is required to make a declaration that
propagating material will be provided within three months of a request
by the Plant Variety Protection Office. Failure to provide propagating
material as requested shall result in the certificate being regarded as
abandoned.
(iii) The delay waiver is effective until the Plant Variety
Protection Office notifies the applicant that the technical
infeasibility has been resolved. Upon that notification, the applicant
must provide a deposit within three months. Failure to provide a
deposit shall result in the certificate being regarded as abandoned.
(3) Original deposits of propagating material for asexually
reproduced varieties are not required for applications submitted
between January 6, 2020, and January 6, 2023; provided: That the
applicant is required to make the declarations described in paragraphs
(d)(2)(i) and (ii) of this section.
* * * * *
0
7. Amend Sec. 97.9 by revising paragraphs (b) and (c) to read as
follows:
Sec. 97.9 Drawings and photographs.
* * * * *
(b) Drawings or photographs shall be in color when color is a
distinguishing characteristic of the variety, and the color shall be
described by use of Nickerson's color fan, the Munsell Book of Color,
the Royal Horticultural Society Colour Chart, or other recognized color
chart.
(c) Drawings shall be sent flat, or may be sent in a suitable
mailing tube or by email in high resolution format, in accordance with
instructions furnished by the Commissioner.
* * * * *
0
8. Amend Sec. 97.12 by revising paragraph (a) to read as follows:
Sec. 97.12 Number and filing date of an application.
(a) Applications shall be numbered and dated in sequence in the
order received by the Office. Applicants will be informed in writing,
by mail or email, as soon as practicable of the number and effective
filing date of the application.
* * * * *
0
9. Amend Sec. 97.14 by revising paragraph (d) to read as follows:
Sec. 97.14 Joint applicants.
* * * * *
(d) If a joint owner refuses to join in an application or cannot be
found after diligent effort, the remaining owner may file an
application on behalf of him or herself and the missing owner. Such
application shall be accompanied by a written explanation and shall
state the last known address of the missing owner. Notice of the filing
of the application shall be forwarded by the Office to the missing
owner at the last known address. If such notice is returned to the
Office undelivered, or if the address of the missing owner is unknown,
notice of the filing of the application shall be published once on the
Plant Variety Protection Office website (https://www.ams.usda.gov/PVPO). Prior to the issuance of the certificate, a missing owner may
join in an application by filing a written explanation. A certificate
obtained by fewer than all of the joint owners under this paragraph
conveys the same rights and privileges to said owners as though all of
the original owners had joined in an application.
0
10. Amend Sec. 97.19 by revising the introductory text and paragraph
(c) to read as follows:
Sec. 97.19 Publication of pending applications.
Information relating to pending applications shall be published
periodically as determined by the Commissioner to be necessary in the
public interest. With respect to each application, the Plant Variety
Protection Office website (https://www.ams.usda.gov/PVPO) shall show:
* * * * *
(c) The name of the crop; and
* * * * *
0
11. Amend Sec. 97.20 by revising paragraph (a) to read as follows:
Sec. 97.20 Abandonment for failure to respond within the time limit.
(a) Except as otherwise provided in Sec. 97.104, if an applicant
fails to advance actively his or her application within 30 days after
the date when the last request for action was mailed to the applicant
by the Office, or within such longer time as may be fixed by the
Commissioner, the application shall be deemed abandoned. The filing and
examination fees in such cases will not be refunded.
* * * * *
0
12. Amend Sec. 97.23 by revising paragraph (c) and removing paragraph
(d).
The revision reads as follows:
Sec. 97.23 Voluntary withdrawal and abandonment of an application.
* * * * *
(c) An original application which has been voluntarily withdrawn
shall be returned to the applicant and may be reconsidered only by
refiling and payment of new filing and examination fees.
0
13. Revise Sec. 97.101 to read as follows:
Sec. 97.101 Notice of allowance.
If, on examination, PVPO determines that the applicant is entitled
to a certificate, a notice of allowance shall be sent to the applicant
or his or her attorney or agent of record, if any, requesting
verification of the variety name and of the name of the owner. The
notice will also provide an opportunity for withdrawal of the
application before
[[Page 432]]
certificate issuance. The applicant must respond within 30 days from
the date of the notice of allowance. Thereafter, a fee for delayed
response shall be charged as specified in Sec. 97.175(f).
0
14. Amend Sec. 97.103 by revising paragraph (a) to read as follows:
Sec. 97.103 Issuance of a certificate.
(a) After the notice of allowance has been issued and the applicant
has clearly specified whether or not the variety shall be sold by
variety name only as a class of certified seed, the certificate shall
be promptly issued. Once an election is made and a certificate issued
specifying that seed of the variety shall be sold by variety name only
as a class of certified seed, no waiver of such rights shall be
permitted by amendment of the certificate.
* * * * *
0
15. Revise Sec. 97.104 to read as follows:
Sec. 97.104 Application or certificate abandoned.
(a) Upon request by the Office, the owner shall replenish the seed
or propagating material of the variety and shall pay the handling fee
for replenishment. Samples of seed or propagating material related to
abandoned applications or certificates will be retained or destroyed by
the depository. Failure to replenish seed or propagating material
within 3 months from the date of request shall result in the
certificate being regarded as abandoned. No sooner than 1 year after
the date of such request, notices of abandoned certificates shall be
published on the Plant Variety Protection Office website (https://www.ams.usda.gov/PVPO), indicating that the variety has become open for
use by the public and, if previously specified to be sold by variety
name as ``certified seed only,'' that such restriction no longer
applies.
(b) If the seed or propagating material is submitted within 9
months of the final due date, it may be accepted by the Commissioner as
though no abandonment had occurred. For good cause, the Commissioner
may extend for a reasonable time the period for submitting seed or
propagating material before declaring the certificate abandoned.
(c) A certificate may be voluntarily abandoned by the applicant or
his or her attorney or agent of record or the assignee of record by
notifying the Commissioner in writing. Upon receipt of such notice, the
Commissioner shall publish a notice on the Plant Variety Protection
Office website (https://www.ams.usda.gov/PVPO) that the variety has
become open for use by the public, and if previously specified to be
sold by variety name as ``certified seed only,'' that such restriction
no longer applies.
0
16. Revise Sec. 97.141 to read as follows:
Sec. 97.141 After issuance.
Upon issuance of a certificate, the owner of the variety, or his or
her designee, may label the variety, propagating material of the
variety, or containers of the seed of the variety or plants produced
from such seed or propagating material substantially as follows:
``Unauthorized Propagation Prohibited--(Unauthorized Seed or
Propagating Material Multiplication Prohibited)--U.S. Protected
Variety.'' Where applicable, ``PVPA 1994'' or ``PVPA 1994--Unauthorized
Sales for Reproductive Purposes Prohibited'' may be added to the
notice.
0
17. Revise Sec. 97.142 to read as follows:
Sec. 97.142 For testing or increase.
An owner who contemplates filing an application and releases for
testing or increase seed of the variety or propagating material or
reproducible plant material of the variety may label such plant
material or containers of the seed or plant material substantially as
follows: ``Unauthorized Propagation Prohibited--For Testing (or
Increase) Only.''
0
18. Revise Sec. 97.175 to read as follows:
Sec. 97.175 Fees and charges.
The following fees and charges apply to the services and actions
specified in paragraphs (a) through (f) of this section:
(a) Application:
(1) Initial fee for filing, examination, and certificate issuance--
$5,150
(2) Submission of new application data prior to issuance of
certificate--$432
(3) Granting extensions for responding to data requests--$89
(4) Refunds pursuant to Sec. 97.178 may be issued for portions of
the initial application fee as follows: examination--$3,864, and
certificate issuance--$768.
(b) Reconsideration of application--$589
(c) Revival of an abandoned application--$518
(d) Appeals:
(1) Filing a petition for protest to Commissioner--$4,118
(2) Appeal to Secretary (refundable if appeal overturns protest to
Commissioner)--$4,942
(e) Field inspections or other services requiring travel 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, salary, and administrative costs), in
accordance with standardized government travel regulations.
(f) Any other service not covered in this section, including, but
not limited to, reproduction of records, authentication, correction, or
reissuance of a certificate, recordation or revision of assignment, and
late fees will be charged for at rates prescribed by the Commissioner,
but in no event shall they exceed $97 per employee hour. Charges will
also be made for materials, space, and administrative costs.
0
19. Revise Sec. 97. 177 to read as follows:
Sec. 97.177 Method of payment.
Payments can be submitted through the electronic Plant Variety
Protection system or pay.gov. Checks or money orders shall be made
payable to the Treasurer of the United States. Remittances from foreign
countries must be payable and immediately negotiable in the United
States for the full amount of the prescribed fee. Money sent by mail to
the Office shall be sent at the sender's risk.
0
20. Revise Sec. 97.178 to read as follows:
Sec. 97.178 Refunds.
Money paid by mistake or excess payments shall be refunded, but a
mere change of plans after the payment of money, as when a party
decides to withdraw an application or to withdraw an appeal, shall not
entitle a party to a refund. However, the examination fee shall be
refunded if an application is voluntarily withdrawn or abandoned
pursuant to Sec. 97.23(a) before the examination has begun. The
certificate issuance fee shall be refunded if an application is
voluntarily withdrawn or abandoned after an examination has been
completed and before a certificate has been issued. Amounts of $1 or
less shall not be refunded unless specifically demanded.
0
21. Amend Sec. 97.403 by revising paragraph (d) to read as follows:
Sec. 97.403 Manner of service.
* * * * *
(d) Whenever it shall be found by the Commissioner or Secretary
that none of the above modes of serving the paper is practicable,
service may be by notice, published once on the Plant Variety
Protection Office website (https://www.ams.usda.gov/PVPO).
0
22. Revise Sec. 97.500 to read as follows:
Sec. 97.500 Appeal to U.S. Courts.
Any applicant dissatisfied with the decision of the Secretary on
appeal may appeal to the U.S. Courts of Appeals for the Federal Circuit
or institute a civil
[[Page 433]]
action in the U.S. District Court for the District of Columbia, as set
forth in the Act. In such cases, the appellant or plaintiff shall give
notice to the Secretary, state the reasons for appeal or civil action,
and obtain a certified copy of the record. The certified copy of the
record shall be forwarded to the Court by the Plant Variety Protection
Office on order of, and at the expense of the appellant or plaintiff.
0
23. Amend Sec. 97.600 by revising the heading to read as follows:
Sec. 97.600 Administrative provisions.
* * * * *
0
24. Revise Sec. 97.800 to read as follows:
Sec. 97.800 Publication of public variety descriptions.
Voluntary submissions of varietal descriptions of ``public
varieties'' on forms obtainable from the Office will be accepted for
publication on the Plant Variety Protection Office website (https://www.ams.usda.gov/PVPO). Such publication shall not constitute
recognition that the variety is, in fact, distinct, uniform, and
stable.
Dated: December 18, 2019.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2019-27636 Filed 1-3-20; 8:45 am]
BILLING CODE 3410-02-P