BRS Stakeholder Meeting Agenda

November 7, 2018

10:00 am - 3:30 pm EST

9:30am-10:00 am Registration for Onsite Attendees 

10:00 am Welcome Dick George

BRS Communications Branch Chief 

10:05-10:35 am

BRS: Reflections on FY18 and a Look Forward to

FY19

Mike Firko

APHIS Deputy Administrator for BRS

10:35-10:45 am International Engagement & Outreach Ibrahim Shaqir, Associate Deputy

Administrator for BRS

10:45-11:10 am International Strategy for Plant Breeding

Innovation

Paul Spencer, Director, New Technologies and

Production Methods Division, USDA FAS 

11:10-11:20 am Break

11:20-11:40 am

Biotechnology Research Supported by the 

Biotechnology Risk Assessment Grants (BRAG) 

Program

Sally McCammon, BRS Scientific Advisor

11:40-11:55 am “Am I Regulated?”- Implementation of Process 

Improvements

Bill Doley, BRS Government Relations 

Specialist

11:55am-12:15 pm Agricultural Biotechnology Education and 

Outreach Initiative

Sid Abel, Assistant Deputy Administrator for 

BRS

12:15 pm-1:30 pm Lunch on Your Own

1:30-3:30 pm APHIS eFile Demonstration & Discussion eFile Change Management Team

3:30 pm Adjourn
Secretary Perdue Issues USDA Statement on Plant Breeding Innovation

Release & Contact Info

Press Release

Release No. 0070.18

Contact: USDA Press

Email: press@oc.usda.gov

(Washington, D.C., March 28, 2018) – U.S. Secretary of Agriculture Sonny Perdue today issued a 

statement providing clarification on the U.S. Department of Agriculture’s (USDA) oversight of plants 

produced through innovative new breeding techniques which include techniques called genome 

editing.

Under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that 

could otherwise have been developed through traditional breeding techniques as long as they are not 

plant pests or developed using plant pests. This includes a set of new techniques that are increasingly 

being used by plant breeders to produce new plant varieties that are indistinguishable from those 

developed through traditional breeding methods. The newest of these methods, such as genome 

editing, expand traditional plant breeding tools because they can introduce new plant traits more 

quickly and precisely, potentially saving years or even decades in bringing needed new varieties to 

farmers.

“With this approach, USDA seeks to allow innovation when there is no risk present,” said Secretary 

Perdue. “At the same time, I want to be clear to consumers that we will not be stepping away from our 

regulatory responsibilities. While these crops do not require regulatory oversight, we do have an 

important role to play in protecting plant health by evaluating products developed using modern 

biotechnology. This is a role USDA has played for more than 30 years, and one I will continue to take 

very seriously, as we work to modernize our technology-focused regulations.”

“Plant breeding innovation holds enormous promise for helping protect crops against drought and 

diseases while increasing nutritional value and eliminating allergens,” Perdue said. “Using this science, 

farmers can continue to meet consumer expectations for healthful, affordable food produced in a 

manner that consumes fewer natural resources. This new innovation will help farmers do what we 

aspire to do at USDA: do right and feed everyone.”

USDA is one of three federal agencies which regulate products of food and agricultural technology. 

Together, USDA, the Environmental Protection Agency (EPA) and the Food and Drug Administration 

(FDA) have a Coordinated Framework for the Regulation of Biotechnology that ensures these products 

are safe for the environment and human health. USDA’s regulations focus on protecting plant health; 

FDA oversees food and feed safety; and EPA regulates the sale, distribution, and testing of pesticides in 

order to protect human health and the environment.

USDA continues to coordinate closely with its EPA and FDA partners to fulfill oversight responsibilities 

and provide the appropriate regulatory environment. This ensures the safety of products derived from 

new technologies, while fostering innovation at the same time.

#
Details on USDA Plant Breeding Innovations

Last Modified: Mar 28, 2018

USDA is committed to helping farmers produce healthy, affordable food in a sustainable manner that 

protects this country’s natural resources and offers more choices for consumers. Through innovative 

methods, plant scientists can now create new plant varieties that are indistinguishable from those 

developed through traditional breeding methods. These new approaches to plant breeding include 

methods like genome editing and present tremendous opportunities for farmers and consumers alike 

by making available plants with traits that may protect crops against threats like drought and diseases, 

increase nutritional value, and eliminate allergens. 

In keeping with our responsibility to protect plant health, USDA has carefully reviewed products of 

these new technologies to determine whether they require regulatory oversight. 

As USDA works to modernize its biotechnology regulations, the vision and direction of this Department 

will be to continue to focus regulatory initiatives on the basis of risk to plant health. 

Under its biotechnology regulations, USDA does not currently regulate, or have any plans to regulate 

plants that could otherwise have been developed through traditional breeding techniques as long as 

they are developed without the use of a plant pest as the donor or vector and they are not themselves 

plant pests. This can include plant varieties with the following changes: 

• Deletions—the change to the plant is solely a genetic deletion of any size.

• Single base pair substitutions—the change to the plant is a single base pair substitution.

• Insertions from compatible plant relatives—the change to the plant solely introduces nucleic 

acid sequences from a compatible relative that could otherwise cross with the recipient 

organism and produce viable progeny through traditional breeding.

• Complete Null Segregants—off-spring of a genetically engineered plant that does not retain the 

change of its parent.

USDA will continue working with other Executive Branch Departments, our domestic stakeholders, 

trading partners and international organizations to advance this science-based and practical approach 

that protects plant health while allowing for technological advancements in accordance with the Report 

of the Interagency Task Force on Agriculture and Rural Prosperity

(https://www.usda.gov/sites/default/files/documents/rural-prosperity-report.pdf).

G/SPS/GEN/1658/Rev.3

1 November 2018

(18-6871) Page: 1/2

Committee on Sanitary and Phytosanitary Measures Original: Spanish

INTERNATIONAL STATEMENT ON AGRICULTURAL APPLICATIONS 

OF PRECISION BIOTECHNOLOGY

COMMUNICATION FROM ARGENTINA, AUSTRALIA, BRAZIL, CANADA, THE DOMINICAN REPUBLIC, 

GUATEMALA, HONDURAS, PARAGUAY, THE UNITED STATES OF AMERICA AND URUGUAY

Revision

The following communication, received on 26 October 2018, is being circulated at the request of the 

delegations of Argentina, Australia, Brazil, Canada, the Dominican Republic, Guatemala, Honduras, 

Paraguay, the United States of America and Uruguay.

1 OVERVIEW

1.1. Precision biotechnology techniques, as a whole, constitute an essential tool for agricultural 

innovation. Their use provides farmers with access to products that increase productivity while 

preserving environmental sustainability.

1.2. Global environmental challenges, pest and disease pressures, food insecurity, and changes in 

consumer preferences, among other factors, have made the use and fostering of tools such as 

precision biotechnology vital for increasing the production of safe food.

1.3. In this light, in April 2018, the countries participating in the "Seminar on Genome Editing for 

Regulators", organized by the Inter-American Institute for Cooperation on Agriculture (IICA), shared 

a draft statement on the applications of precision biotechnology.

1.4. The primary objective is to coordinate efforts to ensure that the regulatory approaches for these

techniques, which include gene editing, are scientifically based and internationally harmonized.

1.5. The final text of the international statement is non-binding on supporting countries, but 

provides the necessary guidelines for preventing regulatory asymmetries and, in turn, potential trade 

disruption.

2 TEXT OF THE "INTERNATIONAL STATEMENT ON AGRICULTURAL APPLICATIONS OF 

PRECISION BIOTECHNOLOGY"

2.1. Agricultural innovation has played an essential role in increasing yields and productivity in 

support of growing, prosperous civilizations. Innovations in precision biotechnology, such as gene 

editing, have brought the promise of major improvements in terms of the ease and precision of 

introducing desirable traits into agricultural organisms, as compared to other breeding methods. 

Farmers continually need to broaden access to new tools to improve productivity, plant and animal 

health, and environmental sustainability, and need to help address global challenges such as climate 

change, pest and disease pressures, and the safety and security of worldwide food supplies, as well 

as meet consumer preferences and demands for healthier, higher quality foods at affordable prices. 

Government policies must continue to foster innovation, including in the public sector and by small 

and medium-sized enterprises (SMEs), and mitigate unintended, unnecessary barriers to the entry 

of agricultural products.
G/SPS/GEN/1658/Rev.3

- 2 -

2.2. In some cases, precision biotechnology, such as gene editing, may generate organisms with 

characteristics similar to those obtainable through conventional breeding. In other cases, the 

organisms generated may have characteristics similar to those introduced into organisms using 

recombinant-DNA technologies. In either case, the food, animal, and environmental safety of such 

products can be adequately addressed by existing regulatory frameworks for agricultural products 

and existing safety standards based on the characteristics of the product or organism.

2.3. Governments are engaging in policy discussions on regulatory frameworks and global regulatory 

compatibility to encourage cross-border research collaboration and minimize potential disruptions to 

trade. Differing domestic regulatory approaches for products derived from precision biotechnology

may result not only in international asynchronicity in approvals, but also in asymmetry in regulatory 

approaches, and create potential trade issues that could impede innovation. Recognizing the potential

positive contributions of precision biotechnology to global agriculture, and emphasizing the 

importance of early action to identify avenues to minimize the trade impacts of differing regulatory 

approaches, the undersigned governments acknowledge that:

− Precision biotechnology products have the potential to play a critical role in addressing the 

challenges facing agricultural production, including by contributing to increasing the supply 

of foods and other agricultural products, in a sustainable way;

− Collaborative research efforts and the ability to introduce useful products into the market, 

especially by SMEs and public sector researchers, are necessary to fully realize the potential 

of precision biotechnology;

− Given the differences internationally in approaches used to assess agricultural 

biotechnology, due consideration should be exercised by governments to avoid arbitrary 

and unjustifiable distinctions between end products derived from precision biotechnology 

and similar end products obtained through other production methods;

− To ensure appropriate science- and risk-based approaches consistent with the protection 

of human, animal and plant health and the environment, due consideration should be given 

to available scientific and technical information when updating existing regulatory 

frameworks or applying these frameworks to products of precision biotechnology, and when 

using available flexibility within existing regulatory frameworks for agricultural products;

− Regulatory approaches necessary to help ensure safety (of humans, animals, plants, and 

the environment) in respect of products derived from precision biotechnology should be 

science- and risk-based, transparent, predictable, timely, and consistent with relevant 

international trade obligations;

− Cooperative work by governments to minimize unnecessary barriers to trade related to the 

regulatory oversight of products of precision biotechnology, including the exploring of 

opportunities for regulatory and policy alignment, should be pursued where possible;

− This collaborative work should promote constructive dialogue with trading partners and 

agricultural stakeholders on potential trade issues related to precision biotechnology, so as 

to support open and fair trade and encourage research and innovation;

− Public communication efforts can build trust in regulatory frameworks and improve the 

acceptability of future agricultural innovations that will help farmers address global 

challenges with a view to the production of abundant, safe and affordable food, feed, fibres, 

and energy in the 21st century.
BRS Stakeholder Meeting

November 7, 2018

Afternoon Session, 1:30 - 3:30 pm EST

APHIS eFile Demonstration Agenda

Modernizing APHIS Permitting: Learn Why APHIS is Transitioning Permitting Systems

APHIS eFile Demo: A Preview of the APHIS eFile Customer Portal and BRS Applications

Demo Q&A: Question and Answer Session Following the Demonstration

Preparing for APHIS eFile: Learn How APHIS Will Transition From ePermits to APHIS eFile

Preparing for APHIS eFile Q&A: Question and Answer Session About Transition Plan

Questions? Reach out to us at eFile.Communications@aphis.usda.gov

Transition Plan ePermits to eFile: New Applications