83 FR 22831 - General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Authority To Meet Via Electronic Communications
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service Federal Register Volume 83, Issue 96 (May 17, 2018)
Agricultural Marketing Service
Federal Register Volume 83, Issue 96 (May 17, 2018)
| Page Range | 22831-22832 | |
| FR Document | 2018-10487 |
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)] [Rules and Regulations] [Pages 22831-22832] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10487] ======================================================================== 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. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations [[Page 22831]] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 900 [Doc. No. AMS-SC-17-0086; SC18-900-1 FR] General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Authority To Meet Via Electronic Communications AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This rule amends the general regulations for Federal fruit, vegetable, and specialty crop marketing agreements and marketing orders (orders) and allows such programs to conduct meetings and vote using electronic means of communication. DATES: Effective May 17, 2018. FOR FURTHER INFORMATION CONTACT: Melissa Schmaedick, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, Post Office Box 952, Moab, UT 84532; Telephone: (202) 557-4783, Fax: (435) 259- 1502, or Julie Santoboni, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: Melissa.Schmaedick@ams.usda.gov or Julie.Santoboni@ams.usda.gov. Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202)720-8938, or Email: Richard.Lower@ams.usda.gov. SUPPLEMENTARY INFORMATION: This final rule is issued under the general regulations for Federal marketing agreements and orders (7 CFR part 900), effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the ``Act.'' The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 12866, 13563, and 13175. 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 the Office of Management and Budget's (OMB) Memorandum titled, ``Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs'[thinsp]'' (February 2, 2017). This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling. This final rule authorizes administrative bodies of Federal fruit, vegetable, and specialty crop orders that currently do not have authority to conduct meetings using electronic communication means to do so. This action also stipulates that each program follow its respective quorum and voting requirements when conducting meetings via electronic communication. Lastly, this action allows administrative bodies to recommend, subject to approval by the Secretary of Agriculture (Secretary), new requirements specific to meetings and verifying votes made at meetings conducted other than in-person. Adding this authority increases operating efficiencies by adding flexibility to the methods by which meetings may be held and decisions made. Additionally, time and travel costs of attending meetings will be reduced. Of the 29 fruit, vegetable, and specialty crop orders currently in effect, six either do not have authority to meet other than in person or are limited specifically to phone or mail voting as alternatives. Administrative Procedure Act and Regulatory Flexibility Act This final rule establishes agency rules of practice and procedure. Under the Administrative Procedure Act (APA), prior notice and opportunity for comment are not required for the promulgation of agency rules of practice and procedure. 5 U.S.C. 553 (b)(3)(A). Only substantive rules require publication 30 days prior to their effective date. 5 U.S.C. 553 (d). Therefore, this final rule is effective upon publication in the Federal Register. In addition, because prior notice and opportunity for comment are not required to be provided for this final rule, this rule is exempt from the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Paperwork Reduction Act This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). 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. USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule. A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously-mentioned address in [[Page 22832]] the FOR FURTHER INFORMATION CONTACT section. List of Subjects in 7 CFR Part 900 Administrative practice and procedure, Freedom of information, Marketing agreements, Reporting and recordkeeping requirements. For the reasons set forth above, 7 CFR part 900 is amended as follows: PART 900--GENERAL REGULATIONS 0 1. The authority citation for part 900 continues to read as follows: Authority: 7 U.S.C. 601-674 and 7 U.S.C. 7401. 0 2. Add Sec. 900.83 to subpart E read as follows: Sec. 900.83 Conducting Meetings via Electronic Communication or Otherwise. Notwithstanding any other provisions of a marketing order in this part, administrative bodies of fruit, vegetable, and specialty crop marketing orders, and their committees/subcommittees may, upon due notice to all members and the public: (a) Conduct meetings by any means of communication available, electronic or otherwise, that effectively assembles members and the public, and facilitates open communication. (b) Vote by any means of communication available, electronic or otherwise; Provided, That votes cast are verifiable and that quorum and other procedural requirements of each respective marketing order are met. (c) With the approval of the Secretary, each administrative body may prescribe any additional procedures necessary to carry out the objectives of paragraphs (a) and (b) of this section. Dated: May 11, 2018. Bruce Summers, Acting Administrator, Agricultural Marketing Service. [FR Doc. 2018-10487 Filed 5-16-18; 8:45 am] BILLING CODE 3410-02-P
![22831
Rules and Regulations Federal Register
Vol. 83, No. 96
Thursday, May 17, 2018
This section of the FEDERAL REGISTER regulations for Federal marketing new requirements specific to meetings
contains regulatory documents having general agreements and orders (7 CFR part 900), and verifying votes made at meetings
applicability and legal effect, most of which effective under the Agricultural conducted other than in-person.
are keyed to and codified in the Code of Marketing Agreement Act of 1937, as Adding this authority increases
Federal Regulations, which is published under amended (7 U.S.C. 601–674), hereinafter operating efficiencies by adding
50 titles pursuant to 44 U.S.C. 1510.
referred to as the ‘‘Act.’’ flexibility to the methods by which
The Code of Federal Regulations is sold by The Department of Agriculture meetings may be held and decisions
the Superintendent of Documents. (USDA) is issuing this final rule in made. Additionally, time and travel
conformance with Executive Orders costs of attending meetings will be
12866, 13563, and 13175. Additionally, reduced. Of the 29 fruit, vegetable, and
DEPARTMENT OF AGRICULTURE because this rule does not meet the specialty crop orders currently in effect,
definition of a significant regulatory six either do not have authority to meet
Agricultural Marketing Service action, it does not trigger the other than in person or are limited
requirements contained in Executive specifically to phone or mail voting as
7 CFR Part 900 Order 13771. See the Office of alternatives.
[Doc. No. AMS–SC–17–0086; SC18–900–1 Management and Budget’s (OMB)
FR] Administrative Procedure Act and
Memorandum titled, ‘‘Interim Guidance
Regulatory Flexibility Act
Implementing Section 2 of the Executive
General Regulations for Federal Fruit, Order of January 30, 2017, titled This final rule establishes agency
Vegetable, and Specialty Crop ‘Reducing Regulation and Controlling rules of practice and procedure. Under
Marketing Agreements and Orders; Regulatory Costs’ ’’ (February 2, 2017). the Administrative Procedure Act
Authority To Meet Via Electronic This final rule has been reviewed (APA), prior notice and opportunity for
Communications under Executive Order 12988, Civil comment are not required for the
AGENCY: Agricultural Marketing Service, Justice Reform. It is not intended to promulgation of agency rules of practice
USDA. have retroactive effect. and procedure. 5 U.S.C. 553 (b)(3)(A).
ACTION: Final rule. The Act provides that administrative Only substantive rules require
proceedings must be exhausted before publication 30 days prior to their
SUMMARY: This rule amends the general parties may file suit in court. Under effective date. 5 U.S.C. 553 (d).
regulations for Federal fruit, vegetable, section 608c(15)(A) of the Act, any Therefore, this final rule is effective
and specialty crop marketing handler subject to an order may file upon publication in the Federal
agreements and marketing orders with USDA a petition stating that the Register.
(orders) and allows such programs to order, any provision of the order, or any In addition, because prior notice and
conduct meetings and vote using obligation imposed in connection with opportunity for comment are not
electronic means of communication. the order is not in accordance with law required to be provided for this final
DATES: Effective May 17, 2018. and request a modification of the order rule, this rule is exempt from the
FOR FURTHER INFORMATION CONTACT: or to be exempted therefrom. Such requirements of the Regulatory
Melissa Schmaedick, Marketing Order handler is afforded the opportunity for Flexibility Act, 5 U.S.C. 601, et seq.
and Agreement Division, Specialty a hearing on the petition. After the
Paperwork Reduction Act
Crops Program, AMS, USDA, Post Office hearing, USDA would rule on the
Box 952, Moab, UT 84532; Telephone: petition. The Act provides that the This rule contains no information
(202) 557–4783, Fax: (435) 259–1502, or district court of the United States in any collection or recordkeeping
Julie Santoboni, Marketing Order and district in which the handler is an requirements under the Paperwork
Agreement Division, Specialty Crops inhabitant, or has his or her principal Reduction Act of 1995 (44 U.S.C. 3501–
Program, AMS, USDA, 1400 place of business, has jurisdiction to 3520).
Independence Avenue SW, Stop 0237, review USDA’s ruling on the petition, AMS is committed to complying with
Washington, DC 20250–0237; provided an action is filed not later than the E-Government Act to promote the
Telephone: (202) 720–2491, Fax: (202) 20 days after the date of the entry of the use of the internet and other
720–8938, or Email: ruling. information technologies, to provide
Melissa.Schmaedick@ams.usda.gov or This final rule authorizes increased opportunities for citizen
Julie.Santoboni@ams.usda.gov. administrative bodies of Federal fruit, access to Government information and
Small businesses may request vegetable, and specialty crop orders that services, and for other purposes.
information on complying with this currently do not have authority to USDA has not identified any relevant
regulation by contacting Richard Lower, conduct meetings using electronic Federal rules that duplicate, overlap, or
Marketing Order and Agreement communication means to do so. conflict with this final rule.
Division, Specialty Crops Program, This action also stipulates that each A small business guide on complying
AMS, USDA, 1400 Independence program follow its respective quorum with fruit, vegetable, and specialty crop
amozie on DSK3GDR082PROD with RULES
Avenue SW, STOP 0237, Washington, and voting requirements when marketing agreements and orders may
DC 20250–0237; Telephone: (202) 720– conducting meetings via electronic be viewed at: http://www.ams.usda.gov/
2491, Fax: (202)720–8938, or Email: communication. Lastly, this action rules-regulations/moa/small-businesses.
Richard.Lower@ams.usda.gov. allows administrative bodies to Any questions about the compliance
SUPPLEMENTARY INFORMATION: This final recommend, subject to approval by the guide should be sent to Richard Lower
rule is issued under the general Secretary of Agriculture (Secretary), at the previously-mentioned address in
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![22832 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
the FOR FURTHER INFORMATION CONTACT ACTION: Final rule. authorities and industry experts from
section. Australia, Canada, and New Zealand
SUMMARY: We are amending the Virus- participate as observers.
List of Subjects in 7 CFR Part 900 Serum-Toxin Act regulations The purpose of VICH is to harmonize
Administrative practice and concerning records and reports. This technical requirements for veterinary
procedure, Freedom of information, change requires veterinary biologics medicinal products (both
Marketing agreements, Reporting and licensees and permittees to record and pharmaceuticals and biologics). As a
recordkeeping requirements. submit reports concerning adverse VICH member, the Animal and Plant
For the reasons set forth above, 7 CFR events associated with the use of Health Inspection Service (APHIS)
part 900 is amended as follows: biological products they produce or provides expertise on veterinary
distribute. The information that must be biological products and participates in
PART 900—GENERAL REGULATIONS included in the adverse event reports efforts to enhance harmonization. Both
submitted to the Animal and Plant APHIS and the animal health industry
■ 1. The authority citation for part 900 Health Inspection Service (APHIS) will are committed to seek scientifically
continues to read as follows: be provided in separate guidance based harmonized technical
Authority: 7 U.S.C. 601–674 and 7 U.S.C. documents. These records and reports requirements for the development and
7401. will help ensure that APHIS can provide use of veterinary biological products.
■ 2. Add § 900.83 to subpart E read as complete and accurate information to VICH Guideline GL42:
follows: consumers regarding adverse reactions Pharmacovigilance: Data Elements for
or other problems associated with the Submission of Adverse Events Reports
§ 900.83 Conducting Meetings via use of licensed biological products. specifically addresses the information
Electronic Communication or Otherwise. DATES: Effective June 18, 2018. that should be included when
Notwithstanding any other provisions FOR FURTHER INFORMATION CONTACT: Dr. submitting adverse event reports.2
of a marketing order in this part, Donna L. Malloy, Section Leader, We solicited comments concerning
administrative bodies of fruit, vegetable, Operational Support, Center for our proposal for 60 days ending
and specialty crop marketing orders, Veterinary Biologics Policy, Evaluation, November 3, 2015. We received four
and their committees/subcommittees and Licensing, VS, APHIS, 4700 River comments by that date. They were from
may, upon due notice to all members Road Unit 148, Riverdale, MD 20737– industry associations, a manufacturer of
and the public: 1231; (301) 851–3426. veterinary biologics, and a private
(a) Conduct meetings by any means of citizen. The commenters were generally
SUPPLEMENTARY INFORMATION:
communication available, electronic or supportive of the proposed rule but
otherwise, that effectively assembles Background asked some questions and raised some
members and the public, and facilitates The Virus-Serum-Toxin Act concerns about the provisions. These
open communication. regulations in 9 CFR part 116 (referred comments are discussed below by topic.
(b) Vote by any means of to below as the regulations) contain
communication available, electronic or General Comments
requirements for maintaining detailed
otherwise; Provided, That votes cast are records of information necessary to give One commenter stated that the
verifiable and that quorum and other a complete accounting of all the current system for detecting safety
procedural requirements of each activities within a veterinary biologics issues with products has historically
respective marketing order are met. establishment. These records include worked well. The commenter did not
(c) With the approval of the Secretary, records and reports for unfavorable or believe there have been significant
each administrative body may prescribe unintended events that occur in animals safety issues that have not been detected
any additional procedures necessary to after the use of a biological product. in a timely fashion.
carry out the objectives of paragraphs (a) On September 4, 2015, we published APHIS agrees with the commenter
and (b) of this section. in the Federal Register (80 FR 53475– that the existing system has worked
Dated: May 11, 2018. 53478, Docket No. APHIS–2014–0063) a well. However, we believe that this rule
Bruce Summers, proposal 1 to amend the regulations by will significantly improve the existing
Acting Administrator, Agricultural Marketing establishing definitions for the terms system by enhancing our ability to
Service. adverse event and adverse event report monitor the observed performance of
[FR Doc. 2018–10487 Filed 5–16–18; 8:45 am] and by providing requirements for veterinary biologics. For example,
BILLING CODE 3410–02–P adverse event records and reports. The currently each veterinary biologics
changes we proposed are consistent manufacturer makes an independent
with guidelines set out by the determination concerning whether an
International Cooperation on adverse event report raises questions
DEPARTMENT OF AGRICULTURE
Harmonization of Technical regarding purity, safety, potency,
Animal and Plant Health Inspection Requirements for Registration of efficacy, preparation, testing, or
Service Veterinary Medicinal Products (VICH). distribution, and when and in what
VICH is a unique project conducted manner such a report of the adverse
9 CFR Parts 101 and 116 under the World Organization for event will be provided to APHIS. Thus,
Animal Health that brings together the without explicit reporting requirements
[Docket No. APHIS–2014–0063] concerning adverse events, reports that
regulatory authorities of the European
RIN 0579–AE11 Union, Japan, and the United States and may signal problems concerning the use
amozie on DSK3GDR082PROD with RULES
representatives from the animal health of veterinary biological products may
VSTA Records and Reports Specific to industry in the three regions. Regulatory not all be submitted to APHIS or may
International Standards for not be submitted in a timely manner.
Pharmacovigilance 1 To view the proposed rule, supporting
document, and the comments we received, go to 2 The VICH pharmacovigilance guidelines can be
AGENCY: Animal and Plant Health http://www.regulations.gov/#!docketDetail;D accessed at http://www.vichsec.org/guidelines/
Inspection Service, USDA. =APHIS-2014-0063. pharmacovigilance.html.
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Document Created: 2018-05-17 00:51:38
Document Modified: 2018-05-17 00:51:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | Effective May 17, 2018. | |
| Contact | Melissa Schmaedick, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, Post Office Box 952, Moab, UT 84532; Telephone: (202) 557-4783, Fax: (435) 259- 1502, or Julie Santoboni, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected].gov or [email protected] | |
| FR Citation | 83 FR 22831 | |
| CFR Associated | Administrative Practice and Procedure; Freedom of Information; Marketing Agreements and Reporting and Recordkeeping Requirements |
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