[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
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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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