1. Innovation in Plant Breeding
National Council of Farmer Cooperatives
Government Affairs Committee
November 12, 2015
Jane DeMarchi

2. Plant breeders have always strived to:
Source: BDP
Plant breeders have always strived to:
create new variations of plant characteristics
provide solutions for disease and pest resistance
increase tolerance to environmental stress
achieve higher yields and
meet consumer expectations and grower needs.
Hybrids
Cell culture & mutation breeding
Genetic engineering
Marker assisted breeding
New breeding methods such as gene editing
Each new method builds upon previous methods
Importance to continued innovation and agriculture development

3. Genetic Variability: Fundamental to Plant Breeding*
07/16/96
Genetic Variability: Fundamental to Plant Breeding
Today’s crops come in many varieties. They are the result of over 100 years of plant breeding, utilizing all of the tools available
Examples of natural mutations that aided in crop evolution
–Bitter-free almonds and lima beans
–Seed free bananas, grapes, oranges
––Development of ‘ears’ in corn
The difference in the genes that makes the varieties possible is known as genetic diversity.
It can be both naturally occurring and induced variants of existing genes. Historically this was the source material for new traits
Phil Simon, ARS
Photos: Corbis *

4. Plant breeders today have access to an incredible array of genetic information from both commercial and wild plant varieties.
The genomes of many important crops have been sequenced
The use of molecular markers has helped us identify gene function
Accumulated knowledge provides ability to use and induce genetic variability

5. Genetic Variability: Fundamental to Plant Breeding
Newer breeding methods also use genetic variability as source material
Very specific changes in existing plant genes
Ability to transfer defined pieces of plant’s genetic material
The plant varieties developed using these new tools could, in most cases, be developed through classical breeding
Modern technology allows us the ability to build on genetic variability by:
Making very specific changes in existing plant’s genes
And transferring defined pieces of plant’s genetic material
It’s important to note that the plant varieties developed using these new tolls could, in most cases, be developed through classical breeding. These technologies are simply speeding up the naturally occurring process.
This allows us to more efficiently meet the need for a wide variety of nutritious and high quality products, while supporting sustainable agricultural practices that preserve our environment’s natural resources and biodiversity.

6. Focus on Gene Editing Various methods include:
Talens, Zinc Fingers, Crispers
These methods allow us to precisely change specific DNA sequences in an identified gene
Re-create gene sequence from wild relative—e.g., disease resistance
Target multi-genic characteristics—e.g., output and consumer traits
“Silence” unwanted or deleterious gene
Enhance beneficial genes
Potential Uses:
Tomatoes with resistance to gemini virus
•After more than 30 years of classical breeding with a well-known source of virus resistance, the desired trait cannot be completely separated from undesirable genetics for size and quality
Some genes can only be in on/off mode—editing could allow intermediate expression

7. Is Gene Editing the Same as GMOs?
No stable insertion of a gene
“Foreign” DNA can be removed from final plant variety
Utilizes plants own DNA repair mechanisms
A more precise way of inducing genetic variation (mutation)
A GMO, is a plant developed through a process in which a copy of a desired gene or section of genetic material from one plant or organism is placed in another plant. The only GMOs commercially available in the U.S. are the following eight crops: soybeans, corn (field and sweet), papaya, canola, cotton, alfalfa, sugar beets and summer squash.
Gene editing is different from the GMO process in that:
- There is no stable insertion of a gene
- “Foreign” DNA can be removed from final plant variety
- It utilizes plants own DNA repair mechanisms to repair cuts in the DNA sequence
- And it is a more precise way of inducing genetic variation than existing mechanisms for mutation

8. Importance to Plant Breeders
Gene editing methods can be used across all agriculturally important crops
Efficient and precise
Can reduce R&D and breeding time
Important for plants with long generation times
Important for crops with rapidly evolving diseases and pests
Relatively inexpensive
Widely available to companies of all sizes and public breeders
Example:
The program to develop resistance to late blight, Phytophthora infestans, in potato through classical breeding started in 1959 and in 2005 they delivered two lines that had late blight resistance (Rpi-blb2).  He then showed that this resistance started to break in 2008, so a 50 year program broke in 3 years.  He then show how in 3 years using cisgenesis they could develop resistance lines by transferring one gene (Rpi-chc1) and do in 3 years what had taken 50 years

9. Policy Endpoints
Question is not whether a new plant variety is adequately regulated
FDA already has oversight for all foods derived from plants
APHIS has ample authority to address risks posed by plant pests and noxious weeds
Question is whether a special pre-market review and clearance process is warranted
The question is not whether a new plant variety is adequately regulated
FDA already has oversight for all foods derived from plants
APHIS has ample authority to address risks posed by plant pests and noxious weeds
The question is whether a special pre-market review and clearance process is warranted
Currently Pre-market review processes are focused on:
evaluating those products with traits that go beyond the range and variability found in nature

10. DRAFT CONCEPT Pre-market Review Required No Pre-market Review
Genetic Insertion?
DRAFT CONCEPT
No stable Gene Insertion (e.g., gene editing)
Stable Gene Insertion
Source of DNA?
Not Sexually Compatible
Sexually Compatible (e.g., cisgenics)
AND
“Product” of genetic insertion in final variety? OR
Protein Expressed
No Protein Expressed (e.g., gene silencing)
AND
Protein/trait--History of Safe Use or familiarity? OR
Pre-market Review Required
No Pre-market Review
No History or familiarity
History of Safe Use or familiarity

11. Many Moving Parts Now White House Memo on Coordinated Framework Goals
Clarify roles and responsibilities
Develop a long-term strategy
Timeline is short
Stakeholder input
Comments due Friday, November 13th
On July 2, 2015, the White House, led by the Office of Science and Technology Policy (OSTP), published a memorandum to the heads of the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA), directing the agencies to “modernize the regulatory system for biotechnology products.”
Specifically, the memo directs the agencies to do the following, within one year of the date of the memo:
·        Clarify the current roles and responsibilities of the agencies, including clarification of how the agencies work together to regulate products that may fall under the authorities of multiple agencies;
·        Develop a long-term strategy to ensure the regulatory framework is able to assess the risk, if any, posed by future products of biotechnology; and
·        Commission an independent study by the National Academies of Sciences, Engineering, and Medicine to analyze the “future landscape” of the products of biotechnology.
OSTP’s objectives in launching the initiative include:
·        Ensuring public confidence in the regulatory system
·        Preventing unnecessary barriers to innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulatory system, while continuing to protect health and the environment
The memo also directs the agencies to utilize public engagement in the review process, including at least three public meetings beginning in fall 2015.
Significantly, the memo does not direct the agencies to revise the Coordinated Framework, seek new authorities, or change the current regulatory system; rather, agencies are directed to clarify their current roles and responsibilities, and to develop a forward-looking strategy to anticipate future applications of biotechnology.
Part 340 review should follow OSTP Review

12. APHIS/BRS Review of Part 340 regulations
Notice of Intent (NOI) as soon as December
BRS – “Assess Risk then Regulate”
Good Points
Risk based approach
Bad Points
All new breeding techniques swept into initial review
Too much uncertainty
Trade implications
APHIS plans to change its approach from: “first regulate; second assess risk” to “first assess risk; second decide whether to regulate”. APHIS would put categories of plant/trait combinations through an up-front assessment for noxious weed and plant pest risks. Depending on the assessment’s outcome, APHIS will decide if that plant/trait combination falls under its regulatory authority. If so, oversight would apply throughout a product’s life, e.g., commercial permits.
The initial trigger for an up-front risk assessment would be broad—including not only transgenics, but also cisgenics and gene editing.

13. Safe and Accurate Food Labeling
Definitions
What is genetic engineering or a genetically engineered plant?
HR 1599 does not include new breeding techniques
Impact on Pre-emption

14. International Goal: Consistent Policy End Points
Role of International Seed Federation
Other countries
EU legal interpretation
Japan
Argentina
Australia
Building Alliances

15. Education Key to Consumer Appreciation of Seed and Seed Improvement
More than 75% of consumers feel that the role of technology in agriculture is important
Little appreciation for role of seed in contributing to societal challenges
When people understand the specific benefits of seed improvement, they begin to show more appreciation
Education key to consumer appreciation of seed and seed improvement
Overall, four in five believe that the role of technology in agriculture is important.
Prefer the term “seed improvement.”
Seed improvement enhances quality of life

16. Communication is Key Policy Makers Value Chain Public/consumers
Domestic and International
To a large extent, application of precision breeding tools is being stalled at the research and development stage because of uncertainty over public policy and unclear regulatory status of the new varieties.
Products developed through such breeding tools may be subjected to different regulatory requirements among trading partners, potentially leading to trade impediments and enforcement issues globally.
Unnecessary regulation and oversight of products derived through precision breeding tools would result in undue, costly regulatory burdens, stifle innovation and prevent the uptake of advanced, innovative breeding applications by both industry and public breeders in developed and developing countries.
Communication, across all audiences, about the value and NEED for continued nnovation is critical.

17. Goal: To Have Entire Toolbox Available
Through advancements in agriculture and the development of new crop varieties, humans have historically strived to meet the needs of a continuously growing population and to develop a safe, reliable and sustainable food supply.
As our world’s population grows from today’s seven billion people to an estimated nine billion by the middle of this century, agriculture is faced with the continued challenge of meeting the rapidly growing demand for food, feed, fiber and fuel.
How do we meet this challenge? It’s critical that we have all of the tools available to continue moving research and innovation forward to meet our growing demands at home and around the globe.

18. Thank You