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1. OECD Conference on Genome Editing: Applications in
Agriculture—Implications for Health, Environment and
Regulation
Session 3: Regulatory aspects
Innovation and U.S. Regulation of
the Products of Agricultural
Biotechnology
June 30, 2018
Sally L. McCammon, U.S. Department of Agriculture
Kathleen M. Jones, U.S. Food and Drug Administration
Mike Mendelsohn, U.S. Environmental Protection Agency

2.  Modernizing the Coordinated Framework
 Report of the Task Force on Rural Prosperity
 USDA- U.S. Department of Agriculture
 FDA-U.S. Food and Drug Administration
 EPA-U.S. Environmental Protection Agency
Presentation Outline

3. U.S. Coordinated Framework for Regulation of
Biotechnology Products
• Describes federal regulatory system for evaluating products
of biotechnology
• Based on existing laws that provide basic network of agency
jurisdiction
• Established formal policy in 1986; updated in 1992 and 2017
3

4. Ongoing effort initiated in 2015
Goal: Ensure public confidence in regulatory system and improve
transparency, predictability, coordination, and efficiency of the regulatory
system
Two key documents:
1. 2017 Update to the Coordinated Framework
- Published in January 2017
- Clarifies roles and responsibilities of agencies that regulate
biotechnology products
2. National Strategy for Modernizing the Regulatory System for
Biotechnology Products
- Published in September 2016
- Identifies agency activities to ensures the regulatory system is well-
prepared for the future products of biotechnology
“Modernizing the Regulatory System for
Biotechnology Products”
4

5.  USDA-Animal and Plant Health Inspection
Service (APHIS)
 Protection of Plant Health
 Safety of Veterinary Biologics
 U.S. Environmental Protection Agency (EPA)
 Regulation of Plant Incorporated Protectants (PIPs) as bio-pesticides
 Safe Use of New Pesticides
 Safe Use of Chemicals
 U.S. Food and Drug Administration (FDA)
 Safety of Food, Food Additives and Feed
 Safety of Veterinary and Human Drugs, and Human Biologics
Agency Responsibility

6.  National Strategy for Modernizing the Regulatory System for
Biotechnology Products – September 2016.
 https://obamawhitehouse.archives.gov/sites/default/files/microsite
s/ostp/biotech_national_strategy_final.pdf
 2017 Update of the Coordinated Framework – January 2017.
 https://www.epa.gov/sites/production/files/2017-
01/documents/2017_coordinated_framework_update.pdf
 Future Biotechnology Products and Opportunities to Enhance
Capabilities of the Biotechnology Regulatory System – National Academy
of Sciences – March 2017
 http://nas-sites.org/biotech/
Coordinated Framework Documents

7. Authoritative Scientific Reports
2017
2017
2016
77

8. TASK FORCE ON AGRICULTURE AND RURAL
PROSPERITY
Purpose and function:
To identify legislative, regulatory, and policy
changes to promote agriculture, economic
development, job growth, infrastructure
improvements, technological innovation,
energy security, and quality of life in rural
America.
-October, 2017

9. TASK FORCE ON AGRICULTURE AND RURAL
PROSPERITY
Call to Action:
• e-Connectivity for Rural America
• Supporting a Rural Workforce
• Improving Quality of Life
• Harnessing Technological Innovation
• Economic Development

10. TASK FORCE ON AGRICULTURE AND RURAL
PROSPERITY
Call to Action #4: Harnessing
Technological Innovation
• Stream-lined, science-based Regulatory Policy
for Biotechnology
– Coordinate Federal regulation of biotech products
– Coordinate Interagency action through the Office
of Science and Technology Policy
• Small and mid-sized innovators
• Protect consumers
– Expedite Commercialization of Biotech Products

11. Current USDA-APHIS biotech regulation
Plant Protection Act (2000)
 Regulates movement* of regulated articles
o Importation
o Interstate movement
o Environmental Release
(confined)
*Permit or Notification is required
Organism (living)
1. Genetically engineered
and
2. Plant pest involved (donor,
recipient, vector)

12. * 2017 data collected through September 2017.
0
50
100
150
200
250
300
350
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Cumulative Number of APHIS-Authorized
Permits/Notifications
CRISPR
TALEN
ZFN
*

13. “Am I Regulated” (AIR) Process
• Am I Regulated by
USDA/APHIS?
• Developers submit
“Letter of Inquiry” to
APHIS
64 Letters and
responses (July, 2011-
May 18, 2018)
http://www.aphis.usda.gov/biotechn
ology/am_i_reg.shtml

14. Case-by-Case
Genetic Modification
–Deletion
–Substitution
–Insertion
*FDA, EPA,
APHIS-PPQ
Plant Pest Component
–Donor
–Vector
• Agrobacterium
–Vector Agent
•TALENS

15. Genome Editing “Am I Regulated” Requests
Site Directed
Nuclease
Number of
Inquires
Number
Pending
Number of
Responses *
Meganuclease 4 0 4
Zinc Finger 1 0 1
TALEN 9 0 9
CRISPR 10 2 8
TOTAL 24 2 22
* All are SDN-1, All Responses = Not
Regulated

16. Plants
• Ornamental plants
• Baby’s breath
• Tobacco
• Corn
• Apple
• Grapevine
• Pineapple
• Plum
• Potato
• Soybean
• Arabidopsis
• Loblolly pine
• Grasses
– Kentucky Blue Grass
– Switchgrass
– St. Augustine Grass
– Tall Fescue
– Bahia Grass
– Setaria
• Wheat
• Rice
• Sorghum
• Camelina
• Moss

17. USDA Need for Change
Bring regulation into alignment with the
U.S. Coordinated Framework for the
Regulation of Biotechnology
– Prepare U.S. regulation for products of emerging
technologies of tomorrow
– Focus on GE organisms that pose a risk to Plant
Health
– Regulatory Relief
– Regulatory Experience

18. Secretary Perdue Issues USDA
Statement on Plant Breeding
Innovation
Washington, D.C., March 28, 2018
Clarification of USDA’s oversight of plants
produced through innovative new breeding
techniques, including techniques called
genome editing.

19. • Does not change the existing USDA-APHIS biotech regulation (7 CFR
Part 340).
• Many genome edited plants do not meet the regulation criteria to be
subject to this regulation.
• Maintain a science-based approach to plant breeding innovation
USDA Statement on Plant Breeding Innovation
(continued)
Secretary Perdue Statement on
Plant Breeding Innovation

20. Approach to Plant Breeding Innovation:
Avoid additional regulation of plants
indistinguishable to those developed by
traditional techniques
or
Organisms that are created using techniques
that could otherwise have been produced using:
- Traditional breeding techniques
- Chemical-based mutagenesis
- Radiation based mutagenesis

21. What does this mean in practice?
Organisms with the following alterations would
not be considered regulated under the USDA
proposed approach:
– Deletions
– Single base-pair substitution
– Introduction of sequences from sexually
compatible plant relatives
– Complete null segregants

22. Why issue the clarification statement now?
Clarity about regulatory treatment of plant breeding innovations is
important:
...to help promote international regulatory compatibility, which is
important to minimize trade disruption
…and other countries are already forming policies on plant
breeding innovations such as genome editing
…and engage with stakeholders

23. Thank you!RS
http://www.aphis.usda.gov/biotechnology/index.shtml