2009 PROGRAM COMPONENTS AND INITIATIVES

•MISSION – AND WORK•2008 ACCOMPLISHMENTS•2009 PLANS

WHO IS ETS? First industry-coordinated initiative established to

meet today’s product stewardship and quality management needs

2007 BIO Food & Agricultural Section Governing Board commitment were catalysts for ETS charter

An affiliate of the Biotechnology Industry Organization Officially charted June 16, 2008 Founding Member Representatives serve as Board members

Industry’s commitment to enhance regulatory compliance and product quality for producers and the value chain

To promote the responsible management of plant biotechnology primarily by developing and encouraging implementation of product stewardship practices and by educating the public about those practices.

Excellence Through StewardshipMission

Defining StewardshipResponsible and ethical management of a product from its inception

through to its ultimate use and discontinuation – it includes careful attention to the responsible introduction and use of products.

Gene Discovery

Plant Developme

nt

Seed Marketing

& Distribution

Crop Productio

n Crop Utilizatio

nProduct

Discontinuation

Seed Production

The plant biotechnology industry is committed to the responsible use of the technology

To date, over 40,000 field trials and more than 9,000 permits have been safely completed

Stewardship has been integral part of most companies’ operations since the technology was first developed

WHYIndustry Stewardship

BIO Field Trial Compliance Manual/Workshops Provides an understanding of regulatory requirements for

field trials of biotech corn, cotton and soybeans for food, feed and fiber for researchers and farmers conducting trials.

BIO Confinement of Plant-made Pharmaceuticals and Plant-Made Industrial Products

BIO Containment Analysis and Critical Control Point (CACCP) plan

Insect Resistance Management (Regulatory – EPA) Companies create resistance management plans to delay and

impede the spread of any insect resistance that may emerge.

Other Current Stewardship Programs

PROGRAM COMPONENTS Stewardship Objectives, Principles, and

Management Practices Measure all members must accept and abide by

Guides to Understanding and Implementing Stewardship Programs and Quality Management Systems

Uniform direction for industry members to develop stewardship programs

Global Stewardship Audit Program 3rd party audits to verify that appropriate stewardship

programs and quality management systems are in place in member companies

STEWARDSHIP OBJECTIVES Members achieve full compliance with

applicable regulatory requirements Members maintain plant product

integrity Members work to prevent trade

disruptions and facilitate flow of goods in commerce

Principles and Management Practices Document that stewardship programs are in place for the full

product life cycle Companies include stewardship and quality management

requirements, standards, or specifications in applicable contracts and agreements

Reach out to academics and other seed producers, encouraging them to implement and utilize stewardship programs and quality management systems

Engage others in the food and feed value chain to promote alignment of stewardship programs and quality management systems

Conduct third party audits of stewardship programs & quality management systems

STEWARDHIP GUIDES Specifically designed in a “ready-to-use” format,

and easily adapted to organization-specific activities & operations

Incorporates ISO and HACCP program standards and practices

Companies can use to design own best practices Available for ETS members and non-members Being translated into several languages for

global participation

ETS Guides for Biotechnology-Derived Plant Products

Maintaining Plant Product Integrity Incident Response Management Product Discontinuation Product Launch Stewardship Stewardship

Guide for Maintaining Plant Product Integrity

Includes 5 (stand-alone)modules – can be individually audited against: Research in the Laboratory Research in Containment Facilities Confined Field Trials Plant and Seed Multiplication Commercial Plant and Seed Sales

Steps for a Typical Incident Response Process

Description of Possible Occurrence of Potential Incidents Throughout the Life Cycle

Integrates Practices into overall Planning Process

Guide for Incident Response Management

Guide for Product Discontinuation

Clarifies and Defines “Discontinuation” Provides Considerations for

Discontinuation of Products Gives Steps to Use in Process Includes: SAMPLE – Certification of

Destruction

Guide for Product Launch Stewardship Urges organizations to develop a product launch

stewardship policy Provides steps to guide an organization through

the development of a product launch stewardship policy

Includes a market and trade assessment example

Guide for Stewardship Provides product developers, providers and

stakeholders with stewardship practices along the full plant life cycle

Gives program components to incorporate in each life cycle phase

Defines steps for integrating stewardship into a company quality management program.

Confirms that stewardship programs and quality management systems are in place and practices conform to ETS guidance

Covers all elements of the plant product cycle – from discovery to breeder seed – within scope of company operations

Companies identify locations of audits to occur in regions, sites and activities

ETS Audit Process

ETS office maintains records of qualified auditors Auditors in program must have existing auditing

credentials, participate in ETS training, and pass an examination to become “An ETS Qualified Auditor”

Auditors send completed report to ETS office Documentation maintained of company

participation

ETS Audit Process

Phase I – Implementation (2008) 3 ETS Guides Produced - first Auditor Training

Program ETS founding members agree to Stewardship

Objectives, Principles & Management Practices and self-certify that stewardship programs and QMP systems are in place

ETS Stewardship Audits initiated first in U.S. member companies

Adoption of ETS Program Charter providing program direction

Phase II – Implementation (2009) 2009 ETS Audit Process Defined for Member

Companies Complete third-party audits for all ETS

members for U.S. plant product activities (discovery through breeder seed)

Translation of Guides and Outreach Materials Education and Outreach Program includes

presentations, workshops, exhibits and new website with translated documents

Phase III – Implementation (2010) Expanded global education and outreach

program Third-party audits for ETS member

company global operations across all phases of the product life cycle

ETS non-member participation plan activated

PROGRAM VALUE AND BENEFITSETS participation and adopting stewardship

programs and quality management systems will:– assist a company’s ability to keep up-to-date on

technology and regulatory changes in the industry,– promote the safety of plant biotechnology products

for customers,– minimize the likelihood of unexpected incidents and

mitigate the impact of unintended releases, and– facilitate the free flow of commerce.

CONCLUSIONS Plant biotechnology provides quality products to

the global marketplace for food, fuel, fiber and healing – and its contributions continue to grow.

Stewardship programs enhanced global quality management practices to achieve overall goals of safe products in the market place.

www.ExcellenceThroughStewardship.org

info@ExcellenceThroughStewardship.org

t. 202-292-4684