Regulations and Procedures Under the Plant Variety Protection Act, 422-433 [2019-27636]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[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]



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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.

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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/.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

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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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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