81 FR 90185 - Amendment to the Egg Research and Promotion Rules and Regulations To Update Patents, Copyrights, Trademarks, and Information Provisions
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service Federal Register Volume 81, Issue 240 (December 14, 2016)
Agricultural Marketing Service
Federal Register Volume 81, Issue 240 (December 14, 2016)
| Page Range | 90185-90186 | |
| FR Document | 2016-29988 |
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)] [Rules and Regulations] [Pages 90185-90186] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29988] ======================================================================== 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. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. ======================================================================== Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations [[Page 90185]] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1250 [Doc. No. AMS-LPS-15-0042] Amendment to the Egg Research and Promotion Rules and Regulations To Update Patents, Copyrights, Trademarks, and Information Provisions AGENCY: Agricultural Marketing Service, USDA. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule amends the Patents, Copyrights, Trademarks, Publications, and Product Formulations (IP) language of the Egg Research and Promotion Rules and Regulations (Regulations) to conform with commodity research and promotion program orders created under the Commodity Promotion, Research, and Information Act of 1996 (1996 Act). DATES: Effective January 13, 2017. FOR FURTHER INFORMATION CONTACT: Kenneth R. Payne, Research and Promotion Division; Livestock, Poultry, and Seed Program; AMS, USDA; 1400 Independence Avenue SW., Room 2610-S; Washington, DC 20250; telephone (202) 720-5705; fax (202) 720-1125; or email [email protected]. SUPPLEMENTARY INFORMATION: Executive Order 12866 The Office of Management and Budget (OMB) has waived the review process required by Executive Order 12866 for this action. Executive Order 12988 This rule was reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have a retroactive effect. This action will not preempt any state or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. The Egg Research and Consumer Information Act (Act) [7 U.S.C. 2701 et seq.] provides that administrative proceedings be filed before parties may consider suit in court. Under section 14 of the Act [7 U.S.C. 2713], a person subject to the Egg Promotion and Research Order (Order) may file a petition with the Department of Agriculture (USDA) stating that the Order, any provision of the Order, or any obligation imposed in connection with the Order, is not in accordance with the law and request a modification of the Order or an exemption from the Order. The petitioner is afforded the opportunity for a hearing on the petition. After a hearing, USDA would rule on the petition. The Act provides that district courts of the U.S. in any district in which such person is an inhabitant, or has their principal place of business, has jurisdiction to review USDA's ruling on the petition, if a complaint for this purpose is filed within 20 days after the date of the entry of the ruling. Regulatory Flexibility Act In accordance with the Regulatory Flexibility Act (RFA) [5 U.S.C. 601-612], the Agricultural Marketing Service (AMS) has determined that this rule will not have a significant economic impact on a substantial number of small entities as defined by RFA. The purpose of RFA is to fit regulatory action to scale on businesses subject to such action so that small businesses will not be disproportionately burdened. As such, these changes will not impose a significant impact on persons subject to the program. According to the American Egg Board (Board), in 2015, approximately 181 egg producers were subject to the provisions of the Order, including paying assessments. Under the current Order, producers in the 48 contiguous States of the U.S. and the District of Columbia who own more than 75,000 laying hens currently pay a mandatory assessment of 10 cents per 30-dozen case of eggs sold. Egg handlers are responsible for collecting and remitting assessments to the Board. According to the Board, of those 181 egg producers, about 138 egg handlers collect assessments. Assessments under the program are used by the Board to finance promotion, research, and consumer information programs designed to increase consumer demand for eggs in domestic and international markets. In 13 CFR part 121, the Small Business Administration (SBA) defines small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms as those having annual receipts of no more than $7 million. Under this definition, the vast majority of egg producers that would be affected by this rule would not be considered small entities. Producers owning 75,000 or fewer laying hens are eligible to be exempt from this program. This rule does not impose additional recordkeeping requirements on egg producers or handlers. There are no Federal rules that duplicate, overlap, or conflict with this rule. Paperwork Reduction Act In accordance with OMB regulation 5 CFR part 1320, which implements the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], the information collection and recordkeeping requirements that are imposed by the Order and Rules and Regulations have been approved previously under OMB control number 0581-0093. This rule does not result in a change to those information collection and recordkeeping requirements. Background The Act established a national egg research and promotion program-- administered by the Board--that is financed through industry assessments and subject to oversight by USDA's AMS. This program of promotion, research, and consumer information is designed to strengthen the position of eggs in the marketplace and to establish, maintain, and expand markets for eggs. Under the current Regulations initially established in 1976, any IP financed by assessment funds or other revenues of the Board shall become property of the U.S. Government as represented by the Board. The language does not allow for alternative ownership arrangements. In addition, there is no explicit allowance for alternative ownership arrangements in cases where the Board is not providing all of the funding for a project. According to the Board, the current language in the Order has made negotiating contracts for [[Page 90186]] shared ownership of IP rights with research entities difficult and in some cases impossible. Specifically, a majority of university policies typically reflect a requirement for the university to own any IP created under research projects they conduct, even if the project is funded with outside money. These university policies have made it difficult for the Board to contract with universities for research due to the IP ownership requirements contained in the Order. As a result, USDA is amending Sec. 1250.542 of the Regulations to incorporate language utilized by research and promotion boards created under the 1996 Act that would provide the Board with flexibility in negotiating over the ownership of IP rights. The research and promotion boards created under the 1996 Act have utilized this language to negotiate ownership rights over IP to effectively expend assessment funds to promote agricultural commodities. Summary of Comments AMS published the notice of proposed rulemaking in the Federal Register on March 16, 2016 [81 FR 14021]. The comment period ended on May 16, 2016. AMS received one timely comment from a university. The commenter expressed that it is the policy of the university to retain ownership of intellectual property generated through research funded by external parties and encouraged AMS to adopt policies and rules that closely follow the standard approaches articulated in Federal Government grants. However, the egg research and promotion program is not a grant program and is not subject to Federal grants policy. In addition, the Board does not receive Federal funding. All funds are received from egg producers required under the enabling legislation to pay an assessment to the Board to fund programs designed to increase demand for eggs and egg products both domestically and internationally. Accordingly, AMS did not incorporate the Federal grants policy into the final rule. List of Subjects in 7 CFR Part 1250 Administrative practice and procedure, Advertising, Agricultural research, Eggs and egg products, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, 7 CFR part 1250 is amended as follows: PART 1250--EGG RESEARCH AND PROMOTION 0 1. The authority citation of 7 CFR part 1250 continues to read as follows: Authority: 7 U.S.C. 2701-2718; 7 U.S.C. 7401. 0 2. Revise Sec. 1250.542 to read as follows: Sec. 1250.542 Patents, Copyrights, Inventions, Trademarks, Information, Publications, and Product Formulations. (a) Except as provided in paragraph (b) of this section, any patents, copyrights, inventions, trademarks, information, publications, or product formulations developed through the use of funds collected by the Board under the provisions of this subpart shall be the property of the U.S. Government, as represented by the Board, and shall, along with any rents, royalties, residual payments, or other income from the rental, sales, leasing, franchising, or other uses of such patents, copyrights, inventions, trademarks, information, publications, or product formulations, inure to the benefit of the Board; shall be considered income subject to the same fiscal, budget, and audit controls as other funds of the Board; and may be licensed subject to approval by the Secretary. Upon termination of this subpart, Sec. 1250.358 shall apply to determine disposition of all such property. (b) Should patents, copyrights, inventions, trademarks, information, publications, or product formulations be developed through the use of funds collected by the Board under this subpart and funds contributed by another organization or person, the ownership and related rights to such patents, copyrights, inventions, trademarks, information, publications, or product formulations shall be determined by an agreement between the Board and the party contributing funds towards the development of such patents, copyrights, inventions, trademarks, information, publications, or product formulations in a manner consistent with paragraph (a) of this section. Dated: December 8, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service. [FR Doc. 2016-29988 Filed 12-13-16; 8:45 am] BILLING CODE P
![90185
Rules and Regulations Federal Register
Vol. 81, No. 240
Wednesday, December 14, 2016
This section of the FEDERAL REGISTER preempt any state or local laws, used by the Board to finance promotion,
contains regulatory documents having general regulations, or policies unless they research, and consumer information
applicability and legal effect, most of which present an irreconcilable conflict with programs designed to increase consumer
are keyed to and codified in the Code of this rule. The Egg Research and demand for eggs in domestic and
Federal Regulations, which is published under international markets.
Consumer Information Act (Act) [7
50 titles pursuant to 44 U.S.C. 1510. In 13 CFR part 121, the Small
U.S.C. 2701 et seq.] provides that
The Code of Federal Regulations is sold by administrative proceedings be filed Business Administration (SBA) defines
the Superintendent of Documents. Prices of before parties may consider suit in small agricultural producers as those
new books are listed in the first FEDERAL court. Under section 14 of the Act [7 having annual receipts of no more than
REGISTER issue of each week. U.S.C. 2713], a person subject to the Egg $750,000 and small agricultural service
Promotion and Research Order (Order) firms as those having annual receipts of
may file a petition with the Department no more than $7 million. Under this
DEPARTMENT OF AGRICULTURE of Agriculture (USDA) stating that the definition, the vast majority of egg
Order, any provision of the Order, or producers that would be affected by this
Agricultural Marketing Service any obligation imposed in connection rule would not be considered small
with the Order, is not in accordance entities. Producers owning 75,000 or
7 CFR Part 1250 with the law and request a modification fewer laying hens are eligible to be
[Doc. No. AMS–LPS–15–0042] of the Order or an exemption from the exempt from this program. This rule
Order. The petitioner is afforded the does not impose additional
Amendment to the Egg Research and opportunity for a hearing on the recordkeeping requirements on egg
Promotion Rules and Regulations To petition. After a hearing, USDA would producers or handlers. There are no
Update Patents, Copyrights, rule on the petition. The Act provides Federal rules that duplicate, overlap, or
Trademarks, and Information that district courts of the U.S. in any conflict with this rule.
Provisions district in which such person is an Paperwork Reduction Act
inhabitant, or has their principal place
AGENCY: Agricultural Marketing Service, In accordance with OMB regulation 5
of business, has jurisdiction to review
USDA. CFR part 1320, which implements the
USDA’s ruling on the petition, if a
ACTION: Final rule. Paperwork Reduction Act of 1995 [44
complaint for this purpose is filed
U.S.C. Chapter 35], the information
SUMMARY: This final rule amends the within 20 days after the date of the entry
collection and recordkeeping
Patents, Copyrights, Trademarks, of the ruling.
requirements that are imposed by the
Publications, and Product Formulations Regulatory Flexibility Act Order and Rules and Regulations have
(IP) language of the Egg Research and been approved previously under OMB
In accordance with the Regulatory
Promotion Rules and Regulations control number 0581–0093. This rule
Flexibility Act (RFA) [5 U.S.C. 601–
(Regulations) to conform with does not result in a change to those
612], the Agricultural Marketing Service
commodity research and promotion information collection and
(AMS) has determined that this rule will recordkeeping requirements.
program orders created under the
not have a significant economic impact
Commodity Promotion, Research, and
on a substantial number of small entities Background
Information Act of 1996 (1996 Act).
as defined by RFA. The purpose of RFA The Act established a national egg
DATES: Effective January 13, 2017. is to fit regulatory action to scale on research and promotion program—
FOR FURTHER INFORMATION CONTACT: businesses subject to such action so that administered by the Board—that is
Kenneth R. Payne, Research and small businesses will not be financed through industry assessments
Promotion Division; Livestock, Poultry, disproportionately burdened. As such, and subject to oversight by USDA’s
and Seed Program; AMS, USDA; 1400 these changes will not impose a AMS. This program of promotion,
Independence Avenue SW., Room significant impact on persons subject to research, and consumer information is
2610–S; Washington, DC 20250; the program. designed to strengthen the position of
telephone (202) 720–5705; fax (202) According to the American Egg Board eggs in the marketplace and to establish,
720–1125; or email Kenneth.Payne@ (Board), in 2015, approximately 181 egg maintain, and expand markets for eggs.
ams.usda.gov. producers were subject to the provisions Under the current Regulations
SUPPLEMENTARY INFORMATION: of the Order, including paying initially established in 1976, any IP
assessments. Under the current Order, financed by assessment funds or other
Executive Order 12866 producers in the 48 contiguous States of revenues of the Board shall become
The Office of Management and Budget the U.S. and the District of Columbia property of the U.S. Government as
(OMB) has waived the review process who own more than 75,000 laying hens represented by the Board. The language
required by Executive Order 12866 for currently pay a mandatory assessment does not allow for alternative ownership
of 10 cents per 30-dozen case of eggs arrangements. In addition, there is no
rmajette on DSK2TPTVN1PROD with RULES
this action.
sold. Egg handlers are responsible for explicit allowance for alternative
Executive Order 12988 collecting and remitting assessments to ownership arrangements in cases where
This rule was reviewed under the Board. According to the Board, of the Board is not providing all of the
Executive Order 12988, Civil Justice those 181 egg producers, about 138 egg funding for a project. According to the
Reform. It is not intended to have a handlers collect assessments. Board, the current language in the Order
retroactive effect. This action will not Assessments under the program are has made negotiating contracts for
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![90186 Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Rules and Regulations
shared ownership of IP rights with PART 1250—EGG RESEARCH AND DEPARTMENT OF HEALTH AND
research entities difficult and in some PROMOTION HUMAN SERVICES
cases impossible. Specifically, a
majority of university policies typically ■ 1. The authority citation of 7 CFR part Food and Drug Administration
reflect a requirement for the university 1250 continues to read as follows:
to own any IP created under research 21 CFR Part 1
Authority: 7 U.S.C. 2701–2718; 7 U.S.C.
projects they conduct, even if the [Docket No. FDA–2011–N–0146]
7401.
project is funded with outside money.
These university policies have made it RIN 0910–AH23
■ 2. Revise § 1250.542 to read as
difficult for the Board to contract with follows: Amendments to Accreditation of Third-
universities for research due to the IP
Party Certification Bodies To Conduct
ownership requirements contained in § 1250.542 Patents, Copyrights, Food Safety Audits and To Issue
the Order. Inventions, Trademarks, Information,
Certifications To Provide for the User
As a result, USDA is amending Publications, and Product Formulations.
Fee Program
§ 1250.542 of the Regulations to (a) Except as provided in paragraph
incorporate language utilized by AGENCY: Food and Drug Administration,
(b) of this section, any patents,
research and promotion boards created HHS.
copyrights, inventions, trademarks,
under the 1996 Act that would provide information, publications, or product ACTION: Final rule.
the Board with flexibility in negotiating formulations developed through the use SUMMARY: The Food and Drug
over the ownership of IP rights. The of funds collected by the Board under Administration (FDA, the Agency, or
research and promotion boards created the provisions of this subpart shall be we) is amending its regulations on
under the 1996 Act have utilized this the property of the U.S. Government, as accreditation of third-party certification
language to negotiate ownership rights represented by the Board, and shall, bodies to conduct food safety audits and
over IP to effectively expend assessment along with any rents, royalties, residual to issue certifications to provide for a
funds to promote agricultural payments, or other income from the reimbursement (user fee) program to
commodities. rental, sales, leasing, franchising, or assess fees for the work FDA performs
Summary of Comments other uses of such patents, copyrights, to establish and administer the third-
inventions, trademarks, information, party certification program under the
AMS published the notice of publications, or product formulations, FDA Food Safety Modernization Act
proposed rulemaking in the Federal inure to the benefit of the Board; shall (FSMA).
Register on March 16, 2016 [81 FR be considered income subject to the DATES: This rule is effective January 13,
14021]. The comment period ended on same fiscal, budget, and audit controls 2017.
May 16, 2016. AMS received one timely as other funds of the Board; and may be
comment from a university. The FOR FURTHER INFORMATION CONTACT:
licensed subject to approval by the Sylvia Kim, Office of Foods and
commenter expressed that it is the Secretary. Upon termination of this
policy of the university to retain Veterinary Medicine, Food and Drug
subpart, § 1250.358 shall apply to Administration, 10903 New Hampshire
ownership of intellectual property
determine disposition of all such Ave., Bldg. 1, Rm. 3212, Silver Spring,
generated through research funded by
property. MD 20993–0002, 301–796–7599.
external parties and encouraged AMS to
adopt policies and rules that closely (b) Should patents, copyrights, SUPPLEMENTARY INFORMATION:
follow the standard approaches inventions, trademarks, information,
Table of Contents
articulated in Federal Government publications, or product formulations be
grants. However, the egg research and developed through the use of funds I. Background
promotion program is not a grant collected by the Board under this A. FDA Food Safety Modernization Act
and Section 808 of the Federal Food,
program and is not subject to Federal subpart and funds contributed by Drug, and Cosmetics Act
grants policy. In addition, the Board another organization or person, the B. Third-Party Certification Regulation
does not receive Federal funding. All ownership and related rights to such C. Purpose of This Rulemaking
funds are received from egg producers patents, copyrights, inventions, D. The Proposed Rule
required under the enabling legislation trademarks, information, publications, E. Public Comments
to pay an assessment to the Board to or product formulations shall be II. Legal Authority
fund programs designed to increase determined by an agreement between III. Comments on Who Is Subject to a User
demand for eggs and egg products both Fee Under This Subpart (§ 1.700)
the Board and the party contributing IV. Comments on What User Fees Are
domestically and internationally. funds towards the development of such Established Under This Subpart (§ 1.705)
Accordingly, AMS did not incorporate patents, copyrights, inventions, V. Comments on How Will FDA Notify the
the Federal grants policy into the final trademarks, information, publications, Public About the Fee Schedule (§ 1.710)
rule. or product formulations in a manner VI. Comments on When a User Fee Required
consistent with paragraph (a) of this by This Subpart Must Be Submitted
List of Subjects in 7 CFR Part 1250 (§ 1.715)
section. VII. Comments on Whether User Fees Under
Administrative practice and Dated: December 8, 2016. This Subpart Are Refundable (§ 1.720)
procedure, Advertising, Agricultural VIII. Comments on the Consequences of Not
rmajette on DSK2TPTVN1PROD with RULES
Elanor Starmer,
research, Eggs and egg products, Paying a User Fee Under This Subpart on
Reporting and recordkeeping Administrator, Agricultural Marketing Time (§ 1.725)
requirements. Service. IX. Comments on Possible Exemptions
[FR Doc. 2016–29988 Filed 12–13–16; 8:45 am] X. Economic Analysis of Impacts
For the reasons set forth in the XI. Paperwork Reduction Act of 1995
BILLING CODE P
preamble, 7 CFR part 1250 is amended XII. Analysis of Environmental Impact
as follows: XIII. Federalism
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Document Created: 2016-12-14 00:48:28
Document Modified: 2016-12-14 00:48:28
| 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 January 13, 2017. | |
| Contact | Kenneth R. Payne, Research and Promotion Division; Livestock, Poultry, and Seed Program; AMS, USDA; 1400 Independence Avenue SW., Room 2610-S; Washington, DC 20250; telephone (202) 720-5705; fax (202) 720-1125; or email [email protected] | |
| FR Citation | 81 FR 90185 | |
| CFR Associated | Administrative Practice and Procedure; Advertising; Agricultural Research; Eggs and Egg Products and Reporting and Recordkeeping Requirements |
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