Agricultural Biotechnology in 21st Century - USDA's Perspective

1. United States Department of Agriculture Agricultural Biotechnology in the 21st Century U.S. Department of Agriculture (USDA) Russ Nicely, Agricultural Counselor Office of Agricultural Affairs, United States Embassy Bangkok russ.nicely@fas.usda.gov
2. United States Department of Agriculture U.S. GOVERNMENT & BIOTECH U.S. Department of Agriculture (USDA) Foreign Agriculture Service (FAS) Animal and Plant Health Inspection Service (APHIS) Agriculture Research Service (ARS); National Institute of Food and Agriculture (NIFA) Economic Research Service (ERS) Office of the President, White House U.S. Trade Representative U.S. State Department Environmental Protection Agency Food and Drug Administration U.S. Agency for International Development Agricultural Marketing Service (AMS)
3. United States Department of Agriculture • Assure that plant and plant products derived from biotechnology techniques are safe to be grown and used in the United States. • Once these plant and plant products enter commerce, USDA supports bringing these and other products to the world marketplace. USDA’s Role
4. United States Department of Agriculture The U.S. Department of Agriculture supports the safe and appropriate use of science and technology, including biotechnology, to help meet agricultural challenges and consumer needs of the 21st century. Overall USDA Policy
5. United States Department of Agriculture THE DIFFERENT FLAVORS OF GE Traditional GE: • Uses Agrobacterium or gene guns to introduce DNA. Until recently, most commercially available GE crops were created this way Plant Breeding Innovations: • Newer DNA modification techniques, such as genome editing, used to develop plant varieties • Also called New Plant Breeding Techniques (NPBTs) • Include genome editing techniques CRISPR-Cas9, TALEN, ZFN, etc. • Genome editing techniques advantages Increased precision Greater efficiency
6. United States Department of Agriculture • Ensure environmental safety, human and animal health safety • Promote innovation while addressing protection goals • Cost of regulation should be justified by the benefits of regulation WHY REGULATE?
7. United States Department of Agriculture Current USDA GE Plant Regulation The Plant Protection Act (PPA) of 2000 • Gives USDA authority to oversee […] the spread of plant pests or noxious weeds to protect agriculture, environment, and economy of the United States. • USDA APHIS (Animal and Plant Health Inspection Service) mission: to protect health and value of American agriculture and natural resources.
8. United States Department of Agriculture Current USDA GE Plant Regulation • Under the PPA, regulations for GE organisms that are or have the potential to be plant pests are codified at 7 CFR part 340, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason To Believe Are Plant Pests.” • 7 CFR Part 340: Based on risk to plant health; only triggered if plant pest involved in producing a plant variety, or if the plant variety is a plant pest itself • Submissions and decisions open and transparent to the public (“Am I Regulated” process)
9. United States Department of Agriculture “Am I Regulated” Website
10. United States Department of Agriculture “Am I Regulated:” Genome Editing Examples Waxy Corn (April 2016) CRISPR Cas9 – deletion in waxy (Wx1) gene Anti-browning Mushroom (April 2016) CRISPR Cas9 - deletion in polyphenyl oxidase (ppo) gene Soybean with higher oleic acid (May 2015) TALEN - deletion to fatty acid desaturase 2 (fad2) gene
11. United States Department of Agriculture March 28, 2018: USDA Clarification Statement on Plant Breeding Innovations • Announced March 28, 2018 • Does not change regulation, rather, clarifies how existing USDA policy under 7 CFR Part 340/”Am I Regulated” applies to plant breeding innovations such as genome editing
12. United States Department of Agriculture What does the Statement clarify? • As USDA considers revising its biotech regulations, it does not intend to regulate plants whose DNA is modified by: – Deletions, – Single base pair substitutions – Insertions from compatible plant relatives – Complete null segregants as long as the modified plants are developed without the use of a plant pest as the donor or vector agent and the plant species is not itself a plant pest* *Plant Protection Act definition of plant pest excludes all plants except parasitic plants such as dodder, witchweed, etc.
13. United States Department of Agriculture Why issue the clarification now? Clarity about regulatory treatment of plant breeding innovations is important: • Because techniques like genome editing have an enourmous potential to solve agricultural challenges and benefit global food security • Because products from this new suite of technologies are about to make their way onto the market • To help promote international regulatory convergence, which is important to minimize trade disruption • And because other countries are already forming policies on plant breeding innovations such as genome editing
14. United States Department of Agriculture Scientific Rationale • Products of latest plant breeding innovation techniques often not “GMOs” but contain small, well-defined genome changes that could have been produced through traditional breeding such as chemical or radiation mutagenesis • Chemical and radiation-based mutagenesis has already created thousands of mutations in single organisms • These present no greater risk to plant health than traditionally bred plants as similar changes occur naturally • “Same Risk” = “Same Treatment” under regulatory approach
15. United States Department of Agriculture Trade Perspective: biotech production is global
16. United States Department of Agriculture LEADING GE PRODUCERS Soy Corn Cotton Sugar Beets Canola (rape seed) Argentina 78 % 97 % 95 % Na Na Brazil 96 % 88 % 78 % Na Na Canada 94 % 92 % Na 100 % 93 % China Na Na 95 % Na Na India Na Na 96 % Na Na Paraguay 96 % 44 % 100 % Na Na United States 94 % 92 % 93 % 100 % 90 % Share of GE Crops in Total Production – 2016 Source: ISAAA Brief 52, 2016
17. United States Department of Agriculture Top importers from GE corn producing countries 0 5 10 15 20 25 30 35 40 45 Million Metric Tons Source: Global Trade Atlas http://www.gtis.com/Exporters: Argentina, Brazil, Canada, Paraguay, USA Other Top Countries Saudi Arabia 3.60 Brazil 3.30 Peru 2.90 China 2.81 South Africa 2.29 Morocco 2.14 Indonesia 2.0
18. United States Department of Agriculture Top importers from GE soybean producing countries 84.53 12.87 4.43 3.66 3.23 9.99 10.29 9.98 China EU Mexico India Japan Countries A Countries B Other 101 countries 0 10 20 30 40 50 60 70 80 90 Million Metric Tons Countries A Thailand 2.70 Indonesia 2.59 Taiwan 2.46 Russia 2.24 Countries B Iran 1.79 South Korea 1.59 Vietnam 1.59 Egypt 1.57 Bangladesh 1.51 Philippines 1.16 Turkey 1.08 Source: Global Trade Atlas http://www.gtis.com/Exporters: Argentina, Brazil, Canada, Paraguay, USA
19. United States Department of Agriculture Because trade is global, regulation needs to be consistent internationally…
20. United States Department of Agriculture • Asynchronous Approvals >Limit producers ability to use new products • Low-level Presence >Makes importers vulnerable to rejection • Inadequate Regulatory Systems Not science-based Not Predictable Not Practical Lack of transparency >Lack of approvals causes uncertainty in the marketplace …to avoid trade disruptions
21. United States Department of Agriculture World Trade Organization – Sanitary and Phytosanitary (SPS) Agreement – Countries pledge to base regulations on science “Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5 (provisional measures when scientific data lacking). International Legal Rationale
22. United States Department of Agriculture • In absence of national regulations: Cartagena Protocol on Biosafety (CPB) often used as baseline • New / inexperienced regulatory systems • Regional approaches can address issues of limited resources for regulators – COMESA – Eastern and Southern Africa – UEMOA /WAEMU and ECOWAS In West Africa Regulatory Challenges for Developing Economies
23. United States Department of Agriculture International Regulatory Streamlining initiative • USDA FAS supports development of “Best Practices for Preparation of Biotechnology Regulatory Submissions” • Goal #1: assist public and small/medium enterprise biotech developers to prepare regulatory packages • Goal #2: encourage consistent global approach to environmental and food and feed risk assessments
24. United States Department of Agriculture • ISAAA, CropLife, ILSI, IICA, FAO, and others … • For Capacity Building – U.S. sponsored programs for international audiences • For genome editing regulation: Like Minded Group (see next slide) USDA FAS Collaboration with international partners
25. United States Department of Agriculture Like-Minded Group (LMG) for Innovative Agricultural Biotechnologies LMG Countries: • Argentina • Australia • Brazil • Canada • New Zealand LMG Countries • Paraguay • South Africa • United States • Uruguay Major exporters: • Meat • Bovine Semen • Corn and Soy LMG formed in 2010
26. United States Department of Agriculture LMG– Coordinated Efforts LMG Key Principles • Science-based • No more trade restrictive than necessary • Consistent with international obligations LMG Key Efforts • Promote actions consistent with key principles • Work together on trade challenges
27. United States Department of Agriculture For Further Info. on USDA and GE engagement, please contact: Stacey.Peckins@usda.gov QUESTIONS?

Hinweis der Redaktion

This is an overview of the U.S. agencies and government partners that work on biotechnology issues.

You’ve heard from the regulatory agencies – FDA, EPA, and USDA’s Animal and Plant Health Inspection Service (APHIS)

The Foreign Agricultural Service (FAS) is sister agency of APHIS, we are the primary trade agency of USDA.
The main mission of FAS is to support the export of all U.S. agricultural products. (From corn kernels, to distilled liquor, to baby formula, to animal genetic. In 2016, U.S. Agricultural exports were valued at 134 billion dollars).

USDA has several agencies that have an interest in ag biotechnology –
ARS and National Institute of Food and Agriculture (NIFA) are involved in crop research,
AMS is responsible for implementing the National Bioengineered Food Disclosure Law - because it is marketing, not a safety issue otherwise that would be FDA
ERS assesses the economic impact to producers of biotech crop adoption.

OTHER major U.S. Government partners includes:
The U.S. State Department – staffs embassies in most all countries and supports biotech policies as well as outreach activities.
The U.S. Agency for International Development – provides technical support to biotech crop research and development
U.S. Trade Representatives Office – supports trade negotiations regarding biotech products
So what is USDA’s role?
Why is regulatory policy important

It ensure environmental safety, human, and animal health safety

It promotes innovation while addressing protection goals

And the cost of regulation should be justified by the benefits of the regulation
There is no “GMO” laws in the U.S. Instead…
Additional history:

In January 2017, USDA published a proposed rule (340) that would specifically exclude from regulation some types of genome edited plant products (Deletions, Single base-pair substitutions, Introduction of sequences from sexually compatible relative plants, & Null segregants).
This proposed rule was subsequently withdrawn last November 2017. USDA is currently considering next steps. USDA recognizes the need to provide clear policy direction and we are working hard on this.
Examples for plants made with these new technologies especially gene editing excluded from regulation:

Soybean with higher oleic acid (May 2015):
- TALEN deletion to fatty acid desaturase 2 (fad2) gene

Non-browning white button mushroom (April 2016):
Exempt from regulation acc to USDA’s “Am I regulated” process;
used CRISPR-Cas to generate small deletions between 1 and 14 base pairs long
Result: Knock out of one of six polyphenol oxidase genes (that’s an enzyme that causes browning)  reducing the enzyme’s activity by 30%

Waxy corn (DuPont Pioneer – April 2016):
Exempt from regulation acc to USDA’s “Am I regulated” process.
CRISPR-Cas used to create a deletion in the waxy gene, causing its inactivation.
Result: While normal corn kernels contain 75% amylopectin and 25% amylose, waxy corn kernels contain over 97% amylopectin, essentially eliminating amylose from the kernel.
Amylopectin is more soluble than amylose, making starch from waxy corn a better choice for paper adhesives and food thickeners.

Used CRISPR to create Soybean with drought and salt tolerance (Oct 2017): Climate change adaptation
Many countries are now growing biotech crops.

First let’s look at the major biotech trade data
As we talk about trade, here is an overview of the major producers and the GE products they grow.

I will let you take a look at that.

As you can see for the major row crops they are at nearly 100% of production for the major producers (with few exceptions).
Exports from top 5 GE producing countries - US, Brazil, Argentina, Canada, Paraguay, Top 20 markets.
HS Codes: 230330 DDG, 230310 CGF, 100590 whole corn
Total of all Corn, 2016 MMT

Just for your information, these are the top importers of corn from the top five exporters.
Exports from top 5 GE producing countries - US, Brazil, Argentina, Canada, Paraguay
HS Codes: 1507 (oil), 120810 (meal), 1201 (beans)
Total of all Soy 2016 MMT

These are the top importers of soy from the top five exporters.
So what arte the trade challenges?

-Async approvals – When the one or more countries have approved a product for use, but has not been approved in the importing country. This stops trade. This can be resolved with functioning approval systems.

-LLP: Async approvals results in LLP - unintentional presence of low levels of biotech products are found in shipments.

-The Inadequate Regulatory Systems:
These inadequate regulatory systems lack transparency in the approval process, they use non-scientific criteria, and the delayed decision announcements all affect production and trade.

We estimate value of disrupted trade at around $400 million. This is not necessarily lost trade, as the products normally find other countries that will take the product.
When developing a biotech policy, it is important to keep the WTO commitments in mind.
Most biotechnology trade issues fall under the SPS agreement
It states that
- decision making should be scientific based
- and that SPS measures should only be applied to the extend necessary

(U.S. a member in 1995)
For most developing countries, biosafety regulatory frameworks are a relatively new concept, and governments lack experience in their development.

The Cartagena Protocol on Biosafety is the international treaty on how to manage the movement of LMOs (living modified organisms).
In the absence of national regulations, the CPB sets a baseline for developing regulations.
Many countries go above and beyond the baseline when making their regulations, resulting in regulations that are overly restrictive towards domestic cultivation and trade.

Regulators in these economies are usually responsible for both for GE cultivation and import approvals.
There are hundreds of GE events on the global market, (especially for commodities such as corn, soybean, canola and cotton)
These regulators have limited resources to review full dossiers for all of them.

The implementation of the Protocol is still under negotiation.
The CPB also suggests that there should be a way to handle liability and redress.
(In the absence of national regulations, the CPB sets out the procedures to allow LMOs to move between countries. Once national regulations are in place, they take precedence over the CPB)

Another approach is to develop a regional biosafety policy where member states recognize the biosafety reviews conducted by others in the region.
Examples of regional biosafety policies are these
(COMESA in Eastern and Southern Africa, and UEMOA/WAEMU and ECOWAS in West Africa)
COMESA’s policy is now in effect, and the West African policies are expected within the next year (UEMOA’s was recently notified to the WTO).
Several experienced individuals that have put together multiple regulatory submission packages are working on developing a best practices document to be disseminated through the public research community. It is expected that a draft of this document will be available in September 2018. The hope is that developers that are submitting similar crops or submitting in the same country will have dossiers that contain similar data as a matter of simplifying the process.

In collaboration Don MaKenzie formally of the International Rice Research Center now with Donald Danforth Plant Science Center

Encourage consistency among public and private product developers and regulatory agencies

This is a discrete project and there are no further resources available at this time. However, there is a “community of practice” developing around the document and we can connect developers with this community if they would like.

Contact info:
Melinda Belisle
Science Advisor
USDA FAS
Melinda.belisle@fas.usda.gov.
These are some of the organizations we collaborate with – are you familiar with them?

ISAAA – International Service for the Acquisition of Agri-biotech Applications
CropLife –
ILSI – International Life Science Institute
IICA – Inter-American Institute for Cooperation on Agriculture
FAO- Food and Agriculture Organization of the UN

Capacity Building – the U.S. sponsors a variety of outreach programs on biotech and training opportunities - for governments and organizations.
In December 2010, a group of countries with similar science-based approaches to the regulation of cloning and other agricultural biotechnologies met for the first time to form a group. (loosely based on the World Wine Trade Group.)

These countries are all major exporters of meat, bovine genetics (semen), and/or GE corn and soybeans.

Since that time, the United States has been working with these countries on a number of issues associated with agricultural biotechnologies. These issues include those associated with GE plants, livestock cloning, and most recently, genome editing or precision breeding techniques.
The LMG coordinates its efforts in the promotion of science-based decision making and reduction of non-scientific barriers to trade.

Key Principles of the group are:

Regulations and regulatory decisions should be Science-based
and
No more trade restrictive than necessary
and
Consistent with international obligations

The Like-Minded group’s efforts have focused on

Promoting actions consistent with these key principles
As well as
Identifying opportunities and trade challenges that the LMG can work together on to address or solve, this includes promoting good science and risk communication practices.

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