The document discusses the United States Department of Agriculture's (USDA) role in regulating agricultural biotechnology, including genetically engineered (GE) plants. The USDA aims to assure the environmental safety and human/animal health safety of GE plants while promoting innovation. It oversees GE plant regulation to protect US agriculture. The USDA also clarified that it does not intend to regulate new plant breeding innovations like genome editing as long as they do not involve plant pests. Internationally, the USDA works with other countries and groups to promote consistent, science-based GE regulations and address regulatory challenges.
"I see eyes in my soup": How Delivery Hero implemented the safety system for ...
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)
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
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
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
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.