Administrative Procedures Governing Formulation of a Research and Promotion Order, 45303-45306 [2020-15412]
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45303
Rules and Regulations
Federal Register
Vol. 85, No. 145
Tuesday, July 28, 2020
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1200
[Doc. No. AMS–SC–19–0105]
Administrative Procedures Governing
Formulation of a Research and
Promotion Order
Agricultural Marketing Service,
Agriculture (USDA).
ACTION: Final rule.
AGENCY:
This rule establishes
procedures to govern the formulation of
new research and promotion
programs—or orders—under the
Commodity Promotion, Research, and
Information Act of 1996 (Act). Research
and promotion programs are
administered by boards or councils with
oversight by the United States
Department of Agriculture (USDA). This
rule specifies the process for proposing
such programs to USDA. It also clarifies
that USDA’s Agricultural Marketing
Service (AMS) will continue to require
associations of producers or individuals
proposing new programs to post a bond
or other collateral to reimburse USDA
for the costs of program development.
DATES: Effective date: August 27, 2020.
FOR FURTHER INFORMATION CONTACT:
Heather Pichelman, Promotion and
Economics Division, Specialty Crops
Program, AMS, USDA, 1400
Independence Avenue SW, Room 1406–
S, Stop 0244, Washington, DC 20250–
0244; telephone: (202) 720–9915;
facsimile: (202) 205–2800; or electronic
mail: Heather.Pichelman@usda.gov.
SUPPLEMENTARY INFORMATION: As
authorized under the Act, this final rule
adds a new subpart D to 7 CFR part
1200—Rules of Practice and Procedure
Governing Proceedings Under Research,
Promotion, and Information Programs.
Subpart D addresses procedures specific
to the formulation of new programs
under the Act.
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SUMMARY:
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Executive Orders 12866, 13563, and
13771
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health, and safety
effects; distributive impacts; and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility. This action falls
within a category of regulatory actions
that the Office of Management and
Budget (OMB) exempted from Executive
Order 12866 review. Additionally,
because this 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 Regulatory
Costs’ ’’ (February 2, 2017).
Executive Order 13175
This action has been reviewed in
accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. The review reveals that
this regulation would not have
substantial and direct effects on Tribal
governments and would not have
significant Tribal implications.
Executive Order 12988
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. It is not intended to have
retroactive effect. 7 U.S.C. 7423
provides that the Act shall not affect or
preempt any other Federal or State law
authorizing promotion or research
relating to an agricultural commodity.
Background
This final rule establishes procedures
to govern the formulation of new
research and promotion programs under
the Act. This rule also clarifies that
AMS will continue to require
associations of producers or individuals
proposing new programs to post a bond
or other collateral to reimburse USDA
for the costs of program development.
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Title 7 U.S.C. 7413(b)(1)(B) authorizes
associations of producers of an
agricultural commodity or other
individuals to petition USDA to
establish a research, promotion, and/or
information program with respect to
that commodity. The purpose of such
programs is to provide a framework for
agricultural industries to pool their
resources and combine efforts to
develop new markets, strengthen
existing markets, and conduct important
research and promotion activities. See 7
U.S.C. 7411(b).
USDA’s Agricultural Marketing
Service (AMS) oversees these programs.
With this final rule, AMS is establishing
the following procedures for
formulating new programs so interested
parties are aware of the process and
requirements.
Under § 1200.202(a), an industry
association or individuals may file a
written proposal for a new research and
promotion program with the AMS
Administrator (Administrator). Under
§ 1200.202(b), the Administrator will
consider whether there is broad
industry support for the proposed
program and whether proposed
provisions of the program are
authorized under the Act. The
Administrator will also evaluate
anticipated benefits to the industry and
the economic feasibility of the program.
Finally, the Administrator will consider
whether the proposed program would
tend to effectuate the declared policy of
the Act. Under § 1200.202(c), if the
Administrator determined that the
program will not effectuate the policy of
the Act, AMS will deny the proposal
and would notify the proponent(s),
explaining the grounds for denial.
Under § 1200.202(d), if the
Administrator determined that the
proposed program will likely effectuate
the purposes of the Act by benefitting
producers, handlers, and importers of
the commodity, or others in the
marketing chain, the Administrator will
notify the proponent(s) that AMS will
proceed with program development
and, in accordance with § 1200.204, the
proponent(s) will be required to post a
bond or other collateral to cover AMS
expenses to develop the program.
The Act provides that once a board is
established under an order, the
Secretary of Agriculture (Secretary)
must be reimbursed for all expenses
incurred in the implementation,
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administration, and supervision of the
order, including all referenda costs
incurred in connection with the order.
The board uses assessment funds
collected from regulated entities to
reimburse the Secretary for program
oversight.
However, AMS incurs substantial
expenses in the development process
leading to program establishment. AMS
may conduct industry outreach
meetings, solicit public input, analyze
economic data, draft rulemaking
documents, and conduct initial
referenda. These activities are necessary
to progress toward program
establishment. Typical expenses for
these preliminary activities may
include, but not be limited to, employee
time and travel, supplies, printing, and
mailing.
In some cases, the proponent industry
may elect to defer an initial referendum
for up to three years after the program
is established. In other cases, despite all
efforts of the proponent and AMS to
develop a new program, ultimately the
proposed program may not be
established. Nevertheless, under either
of these scenarios, AMS will have
already incurred expenses related to
program development.
Section 7417(a)(2) of the Act provides
that the Secretary can require the
industry seeking a new program to post
a bond or other collateral to cover the
cost of the initial referendum. In
§ 1200.201, this rule defines cost of the
referendum to mean all the expenses
AMS incurs in the development of a
potential new program, including the
cost of conducting an initial
referendum.
The amount of the bond or collateral
required under § 1200.204 will be based
on unique factors like the projected
number of staff hours involved, the
amount of staff travel necessary for
outreach, the size and complexity of the
proposed program, and the number of
industry members to be polled in an
initial referendum. This will ensure that
AMS will be reimbursed on a timely
basis for all expenses related to program
development, even if the initial
referendum is deferred or if the program
is not established.
Section 1200.202(e) of this rule
specifies that once AMS has worked
with industries or individuals to
develop a proposed order, AMS will
publish the proposal in the Federal
Register to allow public comments on
the proposed program. Based on
comments, AMS will determine
whether to proceed with program
establishment.
Under § 1200.203 of this rule, if AMS
determined to proceed with program
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establishment, the Administrator could
conduct an initial referendum among
the producers, handlers, and importers
who would be subject to assessment
under the program in order to determine
whether they favor establishment of the
program. The Act provides that USDA
could also establish the program and
defer the initial referendum for up to
three years after the program is
established. See 7 U.S.C. 7417(b). In
either case, referendum voters will be
those entities who, during a
representative period determined by the
Administrator, produced, handled, and/
or imported the agricultural commodity.
For referendum expenses incurred after
a program is established, the Secretary
will be reimbursed by the board
appointed to administer the program, as
provided by the Act. See 7 U.S.C.
7417(f).
Under § 1200.205 of this rule, if at any
time during the development process,
based on public comments, referendum
votes, or other information available,
AMS determines that the proposed
program will not tend to effectuate the
policy of the Act, the Administrator will
terminate proceedings and will collect
reimbursement for program
development expenses from the bond or
collateral posted by the program
proponent(s).
This rule will also make other
administrative provisions related to the
establishment of a new program. Section
1200.201 will define other terms
necessary for administration of the
regulation. Section 1200.206 will
provide for the issuance, effectuation,
and publication of the new order.
Final Regulatory Flexibility Act
Analysis
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) requires agencies to
consider the economic impact of each
rule on small entities. The purpose of
the RFA is to fit regulatory actions to the
scale of businesses subject to such
actions so that small businesses will not
be disproportionately burdened. The
purpose of research and promotion
programs is to benefit all sizes of
producers, handlers, and importers of
an agricultural commodity.
The Act makes it possible for
producer associations or other
individuals engaged in specific
agricultural commodity industries to
submit a proposal for a new program. It
is impossible for AMS to determine
which industries may seek research and
promotion programs in the future or to
determine the number or size of
business entities that might propose
such programs. The expenses necessary
for each program’s development depend
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on factors such as projected staff hours
to develop the program, travel expenses
related to outreach, size and complexity
of the proposed program, and the size of
the industry to be polled in a
referendum. Based on its experience
with past program proposals, AMS
estimates that expenses for typical
program development range from
$80,000 to $150,000. Thus, under this
rule, proponents could be required to
post bonds or other collateral to cover
those amounts if AMS agrees to proceed
with program development. Costs to
individuals or businesses will depend
on the number of entities in each
proponent group. Given that we don’t
know the identity or business size of
future program proponents, AMS cannot
determine what economic impact this
rule might have on small entities. Based
on experience with proponents seeking
to establish new programs under the
Act, AMS believes that this rule is
unlikely to have a significant economic
impact on a substantial number of small
entities.
There will be no new direct costs
associated with the implementation of
this rule. This rule codifies procedures
for proposing new research and
promotion programs that have been
practiced since the Act’s adoption in
1996. In addition to specifying the
program proposal process, the rule
clarifies that the cost of the referendum
to be covered by the required bond or
collateral would include all the costs
associated with program development.
Paperwork Reduction Act
No information collection or
recordkeeping requirements are
imposed on the public by this rule.
Accordingly, OMB clearance is not
required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501, Chapter 35.
As with all Federal research and
promotion programs, reports and forms
are periodically reviewed to reduce
information requirements and
duplication by industry and public
sector agencies.
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.
A proposed rule concerning this
action was published in the Federal
Register on April 27, 2020 (85 FR
23246). A 30-day comment period
ending on May 27, 2020, was provided
to allow interested persons to respond
to the proposal. The proposal was also
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made available through the internet by
USDA and the Office of the Federal
Register.
Analysis of Comments
Two comments were received in
response to the proposed rule. Of those
comments, only one was substantive
and related to this proposed rule. This
commenter expressed a concern about
the proposal. The commenter called the
proposed rule a ridiculous idea.
AMS initiated this rule because it
incurs substantial expenses in the
development process leading to program
establishment. The Act already requires
the Secretary to be reimbursed for all
expenses incurred in the
implementation, administration, and
supervision of the order, including all
referenda costs incurred in connection
with the order after a board has been
established. This rule added expenses
AMS incurs to develop a program to this
requirement.
AMS has been requiring associations
of producers or individuals proposing
new programs to post a bond or other
collateral to reimburse USDA for the
costs of program development. This rule
codifies this procedure, along with
others, for proposing new research and
promotion programs. These procedures
have been practiced since the Act’s
adoption in 1996. Therefore, no changes
have been made to this rule based on
the comment.
A definition of ‘‘Secretary’’ has been
added to the Definitions section to
provide clarity.
After consideration of all relevant
matters presented, including the
information and recommendation
submitted by the Board, the comments
received, and other relevant
information, it is hereby found that this
rule, as hereinafter set forth, is
consistent with and would effectuate
the purposes of the Act.
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List of Subjects in 7 CFR Part 1200
Administrative practice and
procedure, Agricultural research,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, AMS amends 7 CFR part 1200
as follows:
PART 1200—RULES OF PRACTICE
AND PROCEDURE GOVERNING
PROCEEDINGS UNDER RESEARCH,
PROMOTION, AND INFORMATION
PROGRAMS
1. The authority citation for part 1200
continues to read as follows:
■
Authority: 7 U.S.C. 2101–2119, 2611–2627,
2701–2718, 2901–2911, 4501–4514, 4801–
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4819, 4901–4916, 6101–6112, 6301–6311,
6401–6417, 7411–7425, 7481–7491, and
7801–7813.
2. Add subpart D, consisting of
§§ 1200.200 through 1200.206, to read
as follows:
■
Subpart D—Administrative Procedures
Governing Formulation of a Research
and Promotion Order
Sec.
1200.200 General.
1200.201 Definitions.
1200.202 Proposals.
1200.203 Initial referendum.
1200.204 Reimbursement of Secretary’s
expenses.
1200.205 Termination of proceedings.
1200.206 Execution of the order.
Authority: 7 U.S.C. 7411–7425.
§ 1200.200
General.
The terms defined/specified in this
subpart shall apply to all research and
promotion programs authorized under
the Act.
§ 1200.201
Definitions.
Act means the Commodity Research,
Promotion, and Information Act of 1996
(7 U.S.C. 7411–7425).
Administrator means the
Administrator of the Agricultural
Marketing Service or any officer or
employee of the United States
Department of Agriculture to whom
authority has been delegated or may
hereafter be delegated to act for the
Administrator.
Cost of the Referendum means all
USDA expenditures related to
development of an order proposal,
including, but not limited to, salaries,
travel, supplies, printing, mailing, and
shipping, and any costs related to an
initial referendum.
Order means any order which may be
issued pursuant to the Act.
Secretary means the United States
Secretary of Agriculture or any officer or
employee of the United States
Department of Agriculture to whom
authority has been delegated or may
hereafter be delegated to act for the
Secretary.
§ 1200.202
Proposals.
(a) An order may be proposed by any
association of producers of an
agricultural commodity, by any person
that may be affected by the issuance of
an order with respect to an agricultural
commodity, or by the Secretary. Any
person or organization other than the
Secretary proposing an order shall file
with the Administrator a written
proposal.
(b) Upon receipt of a proposal, the
Administrator shall investigate and
evaluate the proposal.
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45305
(c) If the proposal is submitted by an
association of producers of the
agricultural commodity or by any
person that may be affected by the
issuance of an order, and the
investigation and consideration lead the
Administrator to conclude that the
proposed order will not tend to
effectuate the declared policy of the Act,
the Administrator shall deny the
proposal. The Administrator will
promptly notify the proponent(s) of
such denial, which will be accompanied
by a brief statement of the grounds for
the denial.
(d) If the proposal was submitted by
an association of producers of the
agricultural commodity or by any
person that may be affected by the
issuance of an order and the
investigation and consideration lead the
Administrator to conclude that an order
will tend to effectuate the declared
policy of the Act, the Administrator will
promptly notify the proponent(s) of
such conclusion, and the proponent(s)
will be required to post a bond or other
collateral in accordance with
§ 1200.204.
(e) If the Administrator concludes that
an order will tend to effectuate the
declared policy of the Act, the
Administrator shall publish the
proposed order in the Federal Register
and give due notice and opportunity for
public comment on the proposed order.
§ 1200.203
Initial referendum.
For the purpose of ascertaining
whether the persons to be covered by an
order favor the order going into effect,
the Administrator may conduct an
initial referendum among persons to be
subject to an assessment under the order
who, during a representative period
determined by the Administrator,
engaged in the production or handling
of the agricultural commodity or the
importation of the agricultural
commodity.
§ 1200.204
expenses.
Reimbursement of Secretary’s
The Administrator may require any
person or organization proposing an
order to post a bond or other collateral
to cover the cost of the referendum as
defined in § 1200.201.
§ 1200.205
Termination of proceedings.
If at any time during development of
a new program the Administrator
concludes, based on public comments,
referendum votes, or other available
information, that an order will not tend
to effectuate the declared policy of the
Act, the Administrator shall terminate
the proceedings and collect
reimbursements from the bond or other
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collateral posted pursuant to § 1200.204
for any expenses incurred in
development of the proposed program.
§ 1200.206
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Execution of the order.
(a) Issuance of the order. The
Administrator shall, if the
Administrator finds that it will tend to
effectuate the purposes of the Act, issue
the final order.
(b) Effective date of order. No order
shall become effective in less than 30
days after its publication in the Federal
Register, unless the Administrator,
upon good cause found and published
with the order, fixes an earlier effective
date.
(c) Notice of issuance. After the
Administrator issues the order, AMS
will publish notice of the order’s
issuance in the Federal Register.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2020–15412 Filed 7–27–20; 8:45 am]
BILLING CODE P
21 CFR Parts 510, 520, 522, 524, and
558
I. Approvals
[Docket No. FDA–2020–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during January,
February, and March 2020. FDA is
informing the public of the availability
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to make technical
amendments to improve the accuracy of
the regulations.
DATES: This rule is effective July 28,
2020.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during
January, February, and March 2020, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
and, for actions requiring review of
safety or effectiveness data, summaries
of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2020
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Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Supplemental approval of an increased
age restriction and reduced withdrawal period in the use of
MAXIBAN (narasin and nicarbazin)
Type A medicated article) with
INTEPRITY (avilamycin) Type A
medicated articles in the manufacture of Type C medicated broiler
feeds.
Original approval as a generic copy of
NADA 119–807.
FOI Summary.
Original approval for the prevention of
heartworm disease; kills adult fleas
and is indicated for the treatment
and prevention of flea infestations,
the treatment and control of tick infestations, and the treatment and
control of roundworm and adult
hookworm infections for one month.
Original approval as a generic copy of
NADA 141–152.
FOI Summary.
January 28, 2020 ...
141–466
Elanco US Inc.,
2500 Innovation
Way, Greenfield,
IN 46140.
Narasin and
nicarbazin and
avilamycin Type
C medicated
broiler feeds.
Chickens .........
February 7, 2020 ...
200–614
Pentobarbital Sodium and Phenytoin Sodium
Injectable Solution.
Dogs ................
February 27, 2020
141–521
Akorn Animal
Health, Inc.,
1925 West Field
Ct., Suite 300,
Lake Forest, IL
60045.
Zoetis Inc., 333
Portage St.,
Kalamazoo, MI
49007.
SIMPARICA TRIO
(sarolaner,
moxidectin, and
pyrantel
chewable tablets)
Chewable Tablet.
Dogs ................
March 10, 2020 ......
200–670
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, County Galway, H62
FH90, Ireland.
SENERGY
(selamectin) Topical Solution.
Dogs and cats
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Public documents
FOI Summary.
FOI Summary.
]]>Agencies
[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Pages 45303-45306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15412]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 85 , No. 145 / Tuesday, July 28, 2020 / Rules
and Regulations
[[Page 45303]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1200
[Doc. No. AMS-SC-19-0105]
Administrative Procedures Governing Formulation of a Research and
Promotion Order
AGENCY: Agricultural Marketing Service, Agriculture (USDA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule establishes procedures to govern the formulation of
new research and promotion programs--or orders--under the Commodity
Promotion, Research, and Information Act of 1996 (Act). Research and
promotion programs are administered by boards or councils with
oversight by the United States Department of Agriculture (USDA). This
rule specifies the process for proposing such programs to USDA. It also
clarifies that USDA's Agricultural Marketing Service (AMS) will
continue to require associations of producers or individuals proposing
new programs to post a bond or other collateral to reimburse USDA for
the costs of program development.
DATES: Effective date: August 27, 2020.
FOR FURTHER INFORMATION CONTACT: Heather Pichelman, Promotion and
Economics Division, Specialty Crops Program, AMS, USDA, 1400
Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-
0244; telephone: (202) 720-9915; facsimile: (202) 205-2800; or
electronic mail: [email protected].
SUPPLEMENTARY INFORMATION: As authorized under the Act, this final rule
adds a new subpart D to 7 CFR part 1200--Rules of Practice and
Procedure Governing Proceedings Under Research, Promotion, and
Information Programs. Subpart D addresses procedures specific to the
formulation of new programs under the Act.
Executive Orders 12866, 13563, and 13771
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health, and safety effects; distributive impacts; and equity).
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, reducing costs, harmonizing rules, and promoting
flexibility. This action falls within a category of regulatory actions
that the Office of Management and Budget (OMB) exempted from Executive
Order 12866 review. Additionally, because this 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
Regulatory Costs' '' (February 2, 2017).
Executive Order 13175
This action has been reviewed in accordance with the requirements
of Executive Order 13175, Consultation and Coordination with Indian
Tribal Governments. The review reveals that this regulation would not
have substantial and direct effects on Tribal governments and would not
have significant Tribal implications.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. It is not intended to have retroactive effect. 7 U.S.C.
7423 provides that the Act shall not affect or preempt any other
Federal or State law authorizing promotion or research relating to an
agricultural commodity.
Background
This final rule establishes procedures to govern the formulation of
new research and promotion programs under the Act. This rule also
clarifies that AMS will continue to require associations of producers
or individuals proposing new programs to post a bond or other
collateral to reimburse USDA for the costs of program development.
Title 7 U.S.C. 7413(b)(1)(B) authorizes associations of producers
of an agricultural commodity or other individuals to petition USDA to
establish a research, promotion, and/or information program with
respect to that commodity. The purpose of such programs is to provide a
framework for agricultural industries to pool their resources and
combine efforts to develop new markets, strengthen existing markets,
and conduct important research and promotion activities. See 7 U.S.C.
7411(b).
USDA's Agricultural Marketing Service (AMS) oversees these
programs. With this final rule, AMS is establishing the following
procedures for formulating new programs so interested parties are aware
of the process and requirements.
Under Sec. 1200.202(a), an industry association or individuals may
file a written proposal for a new research and promotion program with
the AMS Administrator (Administrator). Under Sec. 1200.202(b), the
Administrator will consider whether there is broad industry support for
the proposed program and whether proposed provisions of the program are
authorized under the Act. The Administrator will also evaluate
anticipated benefits to the industry and the economic feasibility of
the program. Finally, the Administrator will consider whether the
proposed program would tend to effectuate the declared policy of the
Act. Under Sec. 1200.202(c), if the Administrator determined that the
program will not effectuate the policy of the Act, AMS will deny the
proposal and would notify the proponent(s), explaining the grounds for
denial. Under Sec. 1200.202(d), if the Administrator determined that
the proposed program will likely effectuate the purposes of the Act by
benefitting producers, handlers, and importers of the commodity, or
others in the marketing chain, the Administrator will notify the
proponent(s) that AMS will proceed with program development and, in
accordance with Sec. 1200.204, the proponent(s) will be required to
post a bond or other collateral to cover AMS expenses to develop the
program.
The Act provides that once a board is established under an order,
the Secretary of Agriculture (Secretary) must be reimbursed for all
expenses incurred in the implementation,
[[Page 45304]]
administration, and supervision of the order, including all referenda
costs incurred in connection with the order. The board uses assessment
funds collected from regulated entities to reimburse the Secretary for
program oversight.
However, AMS incurs substantial expenses in the development process
leading to program establishment. AMS may conduct industry outreach
meetings, solicit public input, analyze economic data, draft rulemaking
documents, and conduct initial referenda. These activities are
necessary to progress toward program establishment. Typical expenses
for these preliminary activities may include, but not be limited to,
employee time and travel, supplies, printing, and mailing.
In some cases, the proponent industry may elect to defer an initial
referendum for up to three years after the program is established. In
other cases, despite all efforts of the proponent and AMS to develop a
new program, ultimately the proposed program may not be established.
Nevertheless, under either of these scenarios, AMS will have already
incurred expenses related to program development.
Section 7417(a)(2) of the Act provides that the Secretary can
require the industry seeking a new program to post a bond or other
collateral to cover the cost of the initial referendum. In Sec.
1200.201, this rule defines cost of the referendum to mean all the
expenses AMS incurs in the development of a potential new program,
including the cost of conducting an initial referendum.
The amount of the bond or collateral required under Sec. 1200.204
will be based on unique factors like the projected number of staff
hours involved, the amount of staff travel necessary for outreach, the
size and complexity of the proposed program, and the number of industry
members to be polled in an initial referendum. This will ensure that
AMS will be reimbursed on a timely basis for all expenses related to
program development, even if the initial referendum is deferred or if
the program is not established.
Section 1200.202(e) of this rule specifies that once AMS has worked
with industries or individuals to develop a proposed order, AMS will
publish the proposal in the Federal Register to allow public comments
on the proposed program. Based on comments, AMS will determine whether
to proceed with program establishment.
Under Sec. 1200.203 of this rule, if AMS determined to proceed
with program establishment, the Administrator could conduct an initial
referendum among the producers, handlers, and importers who would be
subject to assessment under the program in order to determine whether
they favor establishment of the program. The Act provides that USDA
could also establish the program and defer the initial referendum for
up to three years after the program is established. See 7 U.S.C.
7417(b). In either case, referendum voters will be those entities who,
during a representative period determined by the Administrator,
produced, handled, and/or imported the agricultural commodity. For
referendum expenses incurred after a program is established, the
Secretary will be reimbursed by the board appointed to administer the
program, as provided by the Act. See 7 U.S.C. 7417(f).
Under Sec. 1200.205 of this rule, if at any time during the
development process, based on public comments, referendum votes, or
other information available, AMS determines that the proposed program
will not tend to effectuate the policy of the Act, the Administrator
will terminate proceedings and will collect reimbursement for program
development expenses from the bond or collateral posted by the program
proponent(s).
This rule will also make other administrative provisions related to
the establishment of a new program. Section 1200.201 will define other
terms necessary for administration of the regulation. Section 1200.206
will provide for the issuance, effectuation, and publication of the new
order.
Final Regulatory Flexibility Act Analysis
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires
agencies to consider the economic impact of each rule on small
entities. The purpose of the RFA is to fit regulatory actions to the
scale of businesses subject to such actions so that small businesses
will not be disproportionately burdened. The purpose of research and
promotion programs is to benefit all sizes of producers, handlers, and
importers of an agricultural commodity.
The Act makes it possible for producer associations or other
individuals engaged in specific agricultural commodity industries to
submit a proposal for a new program. It is impossible for AMS to
determine which industries may seek research and promotion programs in
the future or to determine the number or size of business entities that
might propose such programs. The expenses necessary for each program's
development depend on factors such as projected staff hours to develop
the program, travel expenses related to outreach, size and complexity
of the proposed program, and the size of the industry to be polled in a
referendum. Based on its experience with past program proposals, AMS
estimates that expenses for typical program development range from
$80,000 to $150,000. Thus, under this rule, proponents could be
required to post bonds or other collateral to cover those amounts if
AMS agrees to proceed with program development. Costs to individuals or
businesses will depend on the number of entities in each proponent
group. Given that we don't know the identity or business size of future
program proponents, AMS cannot determine what economic impact this rule
might have on small entities. Based on experience with proponents
seeking to establish new programs under the Act, AMS believes that this
rule is unlikely to have a significant economic impact on a substantial
number of small entities.
There will be no new direct costs associated with the
implementation of this rule. This rule codifies procedures for
proposing new research and promotion programs that have been practiced
since the Act's adoption in 1996. In addition to specifying the program
proposal process, the rule clarifies that the cost of the referendum to
be covered by the required bond or collateral would include all the
costs associated with program development.
Paperwork Reduction Act
No information collection or recordkeeping requirements are imposed
on the public by this rule. Accordingly, OMB clearance is not required
by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, Chapter 35.
As with all Federal research and promotion programs, reports and
forms are periodically reviewed to reduce information requirements and
duplication by industry and public sector agencies.
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.
A proposed rule concerning this action was published in the Federal
Register on April 27, 2020 (85 FR 23246). A 30-day comment period
ending on May 27, 2020, was provided to allow interested persons to
respond to the proposal. The proposal was also
[[Page 45305]]
made available through the internet by USDA and the Office of the
Federal Register.
Analysis of Comments
Two comments were received in response to the proposed rule. Of
those comments, only one was substantive and related to this proposed
rule. This commenter expressed a concern about the proposal. The
commenter called the proposed rule a ridiculous idea.
AMS initiated this rule because it incurs substantial expenses in
the development process leading to program establishment. The Act
already requires the Secretary to be reimbursed for all expenses
incurred in the implementation, administration, and supervision of the
order, including all referenda costs incurred in connection with the
order after a board has been established. This rule added expenses AMS
incurs to develop a program to this requirement.
AMS has been requiring associations of producers or individuals
proposing new programs to post a bond or other collateral to reimburse
USDA for the costs of program development. This rule codifies this
procedure, along with others, for proposing new research and promotion
programs. These procedures have been practiced since the Act's adoption
in 1996. Therefore, no changes have been made to this rule based on the
comment.
A definition of ``Secretary'' has been added to the Definitions
section to provide clarity.
After consideration of all relevant matters presented, including
the information and recommendation submitted by the Board, the comments
received, and other relevant information, it is hereby found that this
rule, as hereinafter set forth, is consistent with and would effectuate
the purposes of the Act.
List of Subjects in 7 CFR Part 1200
Administrative practice and procedure, Agricultural research,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, AMS amends 7 CFR part
1200 as follows:
PART 1200--RULES OF PRACTICE AND PROCEDURE GOVERNING PROCEEDINGS
UNDER RESEARCH, PROMOTION, AND INFORMATION PROGRAMS
0
1. The authority citation for part 1200 continues to read as follows:
Authority: 7 U.S.C. 2101-2119, 2611-2627, 2701-2718, 2901-2911,
4501-4514, 4801-4819, 4901-4916, 6101-6112, 6301-6311, 6401-6417,
7411-7425, 7481-7491, and 7801-7813.
0
2. Add subpart D, consisting of Sec. Sec. 1200.200 through 1200.206,
to read as follows:
Subpart D--Administrative Procedures Governing Formulation of a
Research and Promotion Order
Sec.
1200.200 General.
1200.201 Definitions.
1200.202 Proposals.
1200.203 Initial referendum.
1200.204 Reimbursement of Secretary's expenses.
1200.205 Termination of proceedings.
1200.206 Execution of the order.
Authority: 7 U.S.C. 7411-7425.
Sec. 1200.200 General.
The terms defined/specified in this subpart shall apply to all
research and promotion programs authorized under the Act.
Sec. 1200.201 Definitions.
Act means the Commodity Research, Promotion, and Information Act of
1996 (7 U.S.C. 7411-7425).
Administrator means the Administrator of the Agricultural Marketing
Service or any officer or employee of the United States Department of
Agriculture to whom authority has been delegated or may hereafter be
delegated to act for the Administrator.
Cost of the Referendum means all USDA expenditures related to
development of an order proposal, including, but not limited to,
salaries, travel, supplies, printing, mailing, and shipping, and any
costs related to an initial referendum.
Order means any order which may be issued pursuant to the Act.
Secretary means the United States Secretary of Agriculture or any
officer or employee of the United States Department of Agriculture to
whom authority has been delegated or may hereafter be delegated to act
for the Secretary.
Sec. 1200.202 Proposals.
(a) An order may be proposed by any association of producers of an
agricultural commodity, by any person that may be affected by the
issuance of an order with respect to an agricultural commodity, or by
the Secretary. Any person or organization other than the Secretary
proposing an order shall file with the Administrator a written
proposal.
(b) Upon receipt of a proposal, the Administrator shall investigate
and evaluate the proposal.
(c) If the proposal is submitted by an association of producers of
the agricultural commodity or by any person that may be affected by the
issuance of an order, and the investigation and consideration lead the
Administrator to conclude that the proposed order will not tend to
effectuate the declared policy of the Act, the Administrator shall deny
the proposal. The Administrator will promptly notify the proponent(s)
of such denial, which will be accompanied by a brief statement of the
grounds for the denial.
(d) If the proposal was submitted by an association of producers of
the agricultural commodity or by any person that may be affected by the
issuance of an order and the investigation and consideration lead the
Administrator to conclude that an order will tend to effectuate the
declared policy of the Act, the Administrator will promptly notify the
proponent(s) of such conclusion, and the proponent(s) will be required
to post a bond or other collateral in accordance with Sec. 1200.204.
(e) If the Administrator concludes that an order will tend to
effectuate the declared policy of the Act, the Administrator shall
publish the proposed order in the Federal Register and give due notice
and opportunity for public comment on the proposed order.
Sec. 1200.203 Initial referendum.
For the purpose of ascertaining whether the persons to be covered
by an order favor the order going into effect, the Administrator may
conduct an initial referendum among persons to be subject to an
assessment under the order who, during a representative period
determined by the Administrator, engaged in the production or handling
of the agricultural commodity or the importation of the agricultural
commodity.
Sec. 1200.204 Reimbursement of Secretary's expenses.
The Administrator may require any person or organization proposing
an order to post a bond or other collateral to cover the cost of the
referendum as defined in Sec. 1200.201.
Sec. 1200.205 Termination of proceedings.
If at any time during development of a new program the
Administrator concludes, based on public comments, referendum votes, or
other available information, that an order will not tend to effectuate
the declared policy of the Act, the Administrator shall terminate the
proceedings and collect reimbursements from the bond or other
[[Page 45306]]
collateral posted pursuant to Sec. 1200.204 for any expenses incurred
in development of the proposed program.
Sec. 1200.206 Execution of the order.
(a) Issuance of the order. The Administrator shall, if the
Administrator finds that it will tend to effectuate the purposes of the
Act, issue the final order.
(b) Effective date of order. No order shall become effective in
less than 30 days after its publication in the Federal Register, unless
the Administrator, upon good cause found and published with the order,
fixes an earlier effective date.
(c) Notice of issuance. After the Administrator issues the order,
AMS will publish notice of the order's issuance in the Federal
Register.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-15412 Filed 7-27-20; 8:45 am]
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