BIOTECH PRODUCTS STEWARDSHIP

National Workshop

On

Pest Risk Assessment and Management

Manila, Philippines May 24-28, 2004

® Registered trademarks of Pioneer Hi-Bred International, Inc.

*YieldGard and the YieldGard Corn Borer Design are trademarks

used under license from Monsanto Co.

Global planting of GM crops – 2003

USAArgentina

CanadaBrazil

ChinaSouth Africa

AustraliaIndia

Romania Uruguay

SpainMexico

Philippines

ColombiaBulgaria

Honduras

GermanyIndonesia

From 1.7 M ha in 1996 to 67.7 M ha planted to

GM crops in 18 countries in 2003

Regulation of Biotech Crops/Products

• The most highly regulated products nowadays

• They are assessed for food, feed and environmental safety before allowed import or cultivation

• Approval could be event-based or product-based

• Pioneer is committed to good stewardship

Stewardship• A process that identifies and reduces Safety,

Health and Environment risks in every stage of the product life cycle

• Conduct business in a way that lessens negative impact on the customers, general public or the environment – today and in the future.

• Activities that contribute to the sustainable use of GM crops and products and demonstrates responsible use

Why is it Important ?

• Society demands safety as the right to operate a business.

• The future will depend on having products that add value and are safe to customers, consumers and the environment

Sustainability and Stewardship – DuPont Ag and Nutrition View

• DuPont has embraced globalization and corporate social responsibility as core elements of sustainability. Stewardship, like safety, is deeply engrained in our approach to business.

– Being responsible for our products over their entire lifecycle

– Voluntarily taking responsibility for our products

– Managing safety, health, and environmental risk

– Meeting society’s needs today without compromising the ability of future generations to provide for their needs

• DuPont seeks to invent, develop, and market technology and innovation that improve peoples’ lives while meeting the needs of customers, shareholders, employees, and society.

• Where we operate, we follow the corporate vision to deliver financial performance and societal value while decreasing our environmental footprint.

Stewardship Efforts at Pioneer

Research and Development Activities

Regulatory Activities

Business and Value Chain Activities

Commercial Product Stewardship

Product Transfer Systems

RIS

K

Experiment Planning

Planting

Pollination

Harvest

Post Trial Monitoring

1 5432

Critical Control Points/Activities

For Experiment Execution

ControlPoint B

ControlPoint C

ControlPoint D

ControlPoint E

ControlPoint F

ControlPoint A

Time/physical isolation, entry list, planting arrangements

Seed distribution in respective plots

Controlled Isolated

Seed/grain disposalCrop destruct

Roguing of volunteers

Site selection, NCBP approval, seed importation,

• Follows voluntary company policies and standards.

– Increase market acceptance

– Reduce customer/consumer risk

– Maintain and enhance company reputation

• Follows mandatory requirements.

– Regulatory agencies

– Legislative bodies

– Contractual obligations

• Mandatory and voluntary stewardship principles are factored into business decisions involving biotech crops.

• Demands cooperation and “buy-in” from highest levels.

Pioneer Stewardship

What does this mean?

Everyone responsible mindset• Assessment at product concept stage

– Allows for turning issues into opportunities– Early “no” decisions

• Consultations at each Gateway• Quality assurance • Field quality assurance • Compliance with regulations –

while in research and development stages• Compliance with post-market regulations –

Product Stewardship

Stewardship – Pioneer

The Case of Allergenic Soybean• Pioneer initiated research on transgenic soybean to

enhance methionine level in poultry feed• Brazil nut chosen as source of the gene• Pioneer discontinued the research in 1993 after

preliminary results from a voluntary experiment suggested that the Brazil nut gene transferred a potential for allergenicity

• FDA regulation would have allowed the product in the market provided it is labeled as having allergenic potential.

Current Issues on Product Stewardship in the Philippines

• Compliance to the Guidelines on Planned Release of Genetically Modified Organisms and Potentially Harmful Exotic Species (NCBP)

• Compliance to the Rules and Regulations for the Importation and Release into the Environment of Plants and Plant Products derived from the use of Modern Biotechnology (Dept. of Agric. – AO # 8)

• Compliance to IRM requirements (DA – MC #17)

Closing

• Product Stewardship is “our license to operate” from society and we have no choice if we want to be here in the future.

• We should take the leadership and invest today so we have permission to operate our business with our partners in the future.

• Education and commitment are basic for our success along our value added chain and the life cycle of our products - “from cradle to grave”.

Takeaway Messages• Stewardship efforts are aligned with Pioneer’s direction and

business goals.

• Stewardship is an organized, integrated and necessary function of our business.

• Stewardship is not a stand-alone discipline but is cross-functional by design.

• Stewardship is a constantly evolving journey that is sensitive to internal and external influence.

• Stewardship done well will be nearly invisible in terms of cost and time, but…

• Stewardship done poorly can be very costly in time, costs and freedom to operate.

Thank You…