Perspectives on the new USDA regulations for GM Crops | GES Colloquium, Part 1 - USDA Oversight Past to Present Video at https://go.ncsu.edu/ges-mediasite Chat resources at https://go.ncsu.edu/ges-usda-panel-chat-links

1. USDA Oversight Past to Present
JENNIFER KUZMA, PHD
CO-DIRECTOR OF GES CENTER
GOODNIGHT-NC GSK FOUNDATION DISTINGUISHED PROFESSOR
SCHOOL OF PUBLIC AND INTERNATIONAL AFFAIRS
Disclaimer:
We are academics trying to understand the new rule. Although we have decades of
experience working with GM crop regulation and genetic engineering & societal issues,
we do not claim to have all the answers about the details or impacts on different sectors.
We are presenting how we understand the process and issues for discussion purposes.
Thank you!

2. Coordinated Framework for Regulation of Biotechnology
No new categories of risks, no new laws needed, “product not process”
EPA BiopesticideFDA GM plant food/feed—FFDCA
• Voluntary
• No determination of safety
USDA Plant Pest Act
• GM plants with plant pest DNA
sequences
EPA FIFRA
• plant incorporated protectants (Bt)
All other plants have been exempted since
mid 2000s-2010
• USDA Am I Regulated Process

3. Why “Plant Pest”?—Historic Artefact

5. USDA Old
Regulatory Paths

6. Am I
regulated?

7. 2017
Proposed
Rule
Invokes
Noxious
Weed and
Plant Pest
Authorities
2020
SECURE
Rule
Only Plant
Pest Risk
Authorities
2008
Proposed
Rule
Invokes
Noxious
Weed and
Plant Pest
Authorities
Bush II
to Obama
Obama
to Trump
Gene editing arises

8. Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule
“organisms modified through GE”
GE is “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or createa genome”
Organism that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product

9. Key Features of SECURE (continued)

10. USDA New
Regulatory Paths
Under SECURE

11. Pros and Cons of SECURE
PROS
Shift to Plant Pest Risk Focus and away from
DNA presence
Tiered approach—exempt things with which
we have experience
Provisioning of information and FR comment
period for some categories
 E.g new USDA exemptions for what could be
achieved from conventional breeding
CONs
•Failure to invoke Noxious Weed provisions of
PPA---despite main risks of 1st gen GM crops
•Exemptions having little to do with potential
product risk
•Lack of public information for self or USDA
confirmed exempt
•Lack of formal assessment & comment period
in FR for RSR determinations

12. Estimate of $8.3M annual cost
savings to private industry
$3.4 M cost to APHIS
Not over $100M so no CBA
mandated by EO 12866
USDA Timeline of
Implementation
of SECURE