[Federal Register Volume 89, Number 127 (Tuesday, July 2, 2024)]
[Notices]
[Pages 54762-54764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14498]
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Notices
Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
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Federal Register / Vol. 89, No. 127 / Tuesday, July 2, 2024 /
Notices
[[Page 54762]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2024-0002]
RIN 0579-AE81
Exploring Pathways to Commercialization for Modified Microbes
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice; request for information.
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SUMMARY: We are notifying the public that the Animal and Plant Health
Inspection Service (APHIS) is soliciting the public to respond to this
Request for Information (RFI) as part of our stakeholder engagement to
explore pathways to commercialization for modified microbes subject to
APHIS jurisdiction, consistent with the APHIS regulations for the
movement of organisms modified or produced through genetic engineering.
In response to the Office of Science and Technology Policy's (OSTP's)
RFI ``Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties
in the Coordinated Framework for the Regulation of Biotechnology''
issued in December 2022 pursuant to Executive Order 14081, multiple
commenters expressed a need for clear regulatory pathways to
commercialization for modified microbes. Therefore, we are requesting
comments from the public regarding pathways to commercialization,
including needs, ideas, and concerns, regarding possible APHIS risk-
based deregulation of modified microbes and other potential regulatory
and non-regulatory pathways to commercialization. The information
provided will help to identify potential criteria and mechanisms for
risk-based deregulation, develop a regulatory framework that could
inform future rulemaking, and identify potential non-regulatory
solutions.
DATES: We will consider all comments that we receive on or before
September 3, 2024.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to www.regulations.gov.
Enter APHIS-2024-0002 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2024-0002, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at Regulations.gov or in our reading room, which is located
in room 1620 of the USDA South Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30
p.m., Monday through Friday, except holidays. To be sure someone is
there to help you, please call (202) 799-7039 before coming.
Response to this RFI is voluntary. Each individual or institution
is requested to submit only one response. Responses should include the
name of the person(s) or organization(s) filing the response. Please
identify your answers by referring to a specific question number within
the response.
Comments submitted in response to this notice are subject to the
Freedom of Information Act (FOIA). Responses to this RFI may be posted
without change online. No proprietary information, copyrighted
information, or personally identifiable information should be submitted
in response to this RFI.
FOR FURTHER INFORMATION CONTACT: Mrs. Chessa Huff-Woodard, Esq., Branch
Chief, Policy, Program, and International Collaborations, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD
20737; (301) 851-3943; [email protected].
SUPPLEMENTARY INFORMATION:
Background
Coordinated Framework
Along with the Environmental Protection Agency (EPA) and the Food
and Drug Administration (FDA), the United States Department of
Agriculture's (USDA's) Animal and Plant Health Inspection Service
(APHIS) and the Food Safety and Inspection Service (FSIS) are
responsible for the oversight and review of organisms modified or
developed using genetic engineering and the foods derived from them. In
1986, the Coordinated Framework for the Regulation of Biotechnology
(Coordinated Framework) was published by the Office of Science and
Technology Policy (OSTP). The Coordinated Framework explains the
regulatory roles for EPA, FDA, and the USDA (APHIS and FSIS), and how
Federal agencies use existing Federal statutes to ensure public health
and environmental safety while maintaining regulatory flexibility to
avoid impeding innovation. The Coordinated Framework was subsequently
updated in 1992 (see 57 FR 6753) and 2017 (see
2017_coordinated_framework_update.pdf) taking into account advances
that had occurred in the field of biotechnology.
APHIS Biotechnology Regulations
The regulations in 7 CFR part 340 govern the movement (importation,
interstate movement, and release into the environment) of certain
organisms, to include plants, plant pests, and biocontrol organisms,
modified or produced through genetic engineering. APHIS first issued
these regulations in 1987 under the authority of the Federal Plant Pest
Act of 1957 and the Plant Quarantine Act of 1912, two acts that were
subsumed into the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) in
2000, along with other provisions. Since 1987, APHIS has amended the
regulations seven times, in 1988, 1990, 1993, 1994, 1997, 2005, and
2020.
The most recent update was on May 18, 2020, when we published in
the Federal Register (85 FR 29790-29838, Docket No. APHIS-2018-0034) a
final rule that marked the first comprehensive revision of the
regulations since they were established in 1987. The May 2020 final
rule provided clear, predictable, and efficient regulatory pathways for
innovators, facilitating the development of plants developed using
genetic engineering that are unlikely to pose plant pest risks.
[[Page 54763]]
The May 2020 final rule included regulatory exemptions for certain
categories of modified plants. Plants are exempt from regulation in
accordance with paragraphs (b), (c), and (d) of Sec. 340.1.
Additionally, Sec. 340.4 of the 2020 final rule included a regulatory
status review (RSR) process for APHIS to determine if a plant developed
or modified using genetic engineering is unlikely to pose an increased
plant pest risk relative to the plant pest risk posed by the respective
non-modified or other appropriate comparator(s) and therefore is not
subject to the regulations. Because most microbes \1\ are not
``plants,'' they do not qualify for an exemption under Sec. 340.1 and
are not eligible for an RSR under Sec. 340.4.
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\1\ The terms ``microbes'' and ``microorganisms'' are used
interchangeably throughout the document because they are synonymous
term; a microbe is a common shortform and colloquial reference.
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Under the May 2020 final rule, modified \2\ microbes that are plant
pests (as the term is defined in Sec. 340.3); or have received
deoxyribonucleic acid (DNA) from a plant pest and the DNA from the
donor organism either is capable of producing an infectious agent that
causes plant disease or encodes a compound that is capable of causing
plant disease; or are used to control plant pests and could pose a
plant pest risk, are subject to the regulations.\3\
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\2\ When we use the term ``modified'' in this notice, we are
referring to genetic engineering (GE) as defined in the regulations.
\3\ 7 CFR part 340.2(b)-(d).
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The May 2020 final rule included permitting exemptions for some
microorganisms. A permit for interstate movement is not required for
disarmed Agrobacterium tumefaciens, provided that it is moved as a
secure shipment, the cloned genetic material is stably integrated into
the genome, and the cloned material does not include the complete
infectious genome of a plant pest. In response to comments on the
proposed rule about interagency coordination, in the May 2020 final
rule, we also added paragraph (f) to Sec. 340.5, which contains an
exemption from permitting requirements for any modified microorganism
that is currently registered with the EPA as a microbial pesticide, so
long as the microorganism is not a plant pest as the term is defined in
Sec. 340.3.
However, the May 2020 rule did not include up-front regulatory
exemptions or a regulatory review process for modified microorganisms.
While several commenters on the proposed rule requested that APHIS
develop a process to evaluate the regulatory status of non-plant
modified organisms, based on the subject organism's potential plant
pest risk, the commenters did not provide specifics on what factors
APHIS should consider in such a process. At the time, APHIS stated that
further discussion and outreach with impacted developers and other
stakeholders would be required before pursuing rulemaking.
Executive Order 14081 and Subsequent RFI
On September 12, 2022, President Biden issued Executive Order
(E.O.) 14081,\4\ ``Advancing Biotechnology and Biomanufacturing
Innovation for a Sustainable, Safe, and Secure American Bioeconomy,''
with the goal of accelerating biotechnology innovation and growing
America's bioeconomy across multiple sectors, including health,
agriculture, and energy. Among other objectives, E.O. 14081 aims to
support the safe use of biotechnology by clarifying and streamlining
regulations in service of a science- and risk-based, predictable,
efficient, and transparent regulatory system to support the safe use of
products of biotechnology. Among other things, E.O. 14081 directs the
EPA, the FDA, and USDA to identify any regulatory ambiguities, gaps, or
uncertainties in the January 2017 update to the Coordinated Framework
for the Regulation of Biotechnology or subsequent policy changes made
by the agencies, through engaging with developers and stakeholders and
horizon scanning for novel biotechnology products, and to provide a
plan with processes and timelines to implement regulatory reform.
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\4\ https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american.
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On December 20, 2022, in connection with E.O. 14081, the White
House Office of Science and Technology Policy (OSTP)--on behalf of the
primary agencies that regulate the products of biotechnology (EPA, FDA,
and USDA), issued a request for information,\5\ or RFI. The RFI
requested relevant data and information, including case studies, that
may assist in identifying any regulatory ambiguities, gaps,
inefficiencies, or uncertainties in the Coordinated Framework for the
Regulation of Biotechnology, particularly regarding new and emerging
biotechnology products. The RFI indicated that the information provided
would inform regulatory agency efforts to improve the clarity and
efficiency of the regulatory processes for biotechnology products.
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\5\ https://www.federalregister.gov/documents/2023/04/27/2023-08841/executive-order-14081-advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe.
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There has been significant investment and growth over the last few
years in the development of modified microbes for agricultural and
industrial uses, including for use as biopesticides, fertilizers,
biofuel production, and the manufacture of chemicals and other
materials. A number of comments were received that discussed APHIS'
regulation of modified microbes. Commenters expressed various concerns
including the lack of clarity regarding the regulation of modified
microbes generally, a lack of a clear and predictable pathway to
commercialization, and what were perceived as onerous regulatory
requirements. Commenters suggested APHIS develop regulatory pathways
for commercialization for modified microbes, including exemptions and a
process similar to the RSR process described in Sec. 340.4 for
modified plants. Suggestions for exemptions included exemptions based
on the modification similar to exemptions provided for modified plants
listed in Sec. 340.1, exemptions based on the species of microbe, and
exemptions based on the trait (e.g., barcoding traits). Suggestions
were also made to improve the efficiency of the permitting system for
modified microbes by reducing information requirements for certain
movement permits (approved under OMB control number 0579-0471) and to
set permit conditions that are risk-based and in alignment with
agricultural practices.
Draft Microbial Permits Guide
On March 23, 2023, APHIS made available for review a draft Guide
for Submitting Permit Applications for Microorganisms Developed using
Genetic Engineering Under 7 CFR part 340 on its website at https://www.aphis.usda.gov/aphis/newsroom/stakeholder-info/sa_by_date/sa-2023/microorganism-guide. We indicated that comments should be submitted to
Regulations.gov and received by May 22, 2023. Comments received within
that 60-day comment period were similar to those received to the RFI
related to potential pathways to commercialization for modified
microbes. For example, commenters expressed concern that there were no
processes for modified microbes similar to the up-front exemptions at
Sec. 340.1 and the Regulatory Status Review process at Sec. 340.4 for
modified plants.
Based on this background information, we are soliciting public
comments regarding the following questions:
[[Page 54764]]
RFI Questions
1. Describe new or emerging categories of biotechnology products
that are relevant to the development and use of modified
microorganisms. To assess new and emerging technologies with modified
microbes, what expertise and resources are needed in the government to
evaluate the overall plant pest risk of modified microbes?
2. Describe areas where the clarity and/or efficiency of
regulations governing modified microorganisms could be improved (e.g.,
definitions that need to be provided or revised, barriers to obtaining
the data necessary to achieve commercialization).
3. Describe key elements of a regulatory framework that would
enable a scientifically sound assessment of a modified microorganism's
plant pest risk, in order to inform regulatory decision-making by
APHIS.
a. Describe any biological features of microorganisms that APHIS
should consider when determining whether a modification changes the
plant pest risk, and thus the regulatory status of a modified
microorganism (e.g., the potential for horizontal gene transfer, the
production of airborne spores, its ecological role, or the ability to
remain dormant for long periods of time).
b. What criteria, data, and information should be considered when
assessing a modified microorganism's plant pest risk?
c. What should APHIS consider when determining whether modification
of a biocontrol organism could result in it posing a plant pest risk?
Provide scientific evidence to support which types of biocontrol
organisms and methods could or could not pose a plant pest risk.
4. How should modified microorganisms with multiple uses (e.g.,
developed for both biomedical or pharmaceutical purposes and
agricultural purposes) be regulated and evaluated by APHIS? What steps
should APHIS take to ensure efficient and appropriate oversight and
evaluation when a product is subject to regulation and review by both
USDA and another Federal agency?
5. Should APHIS consider risk-based exemptions for certain types of
microorganisms, or for certain modifications in microorganisms? If so,
please provide examples of the types of modified microorganisms that
should be exempt from regulation and provide scientific evidence to
support which modifications and types of microorganisms should or
should not be exempt.
6. Are there any other specific issues or topics APHIS should
consider in developing a regulatory framework for assessing the plant
pest risk of modified microorganisms, or possible pathways to
commercialization for modified microorganisms?
We welcome all comments on the issues outlined above.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 26th day of June 2024.
Katherine Zenk,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2024-14498 Filed 7-1-24; 8:45 am]
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