2009 PROGRAM COMPONENTS AND INITIATIVES. MISSION AND WORK 2008 ACCOMPLISHMENTS 2009 PLANS.
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Transcript of 2009 PROGRAM COMPONENTS AND INITIATIVES. MISSION AND WORK 2008 ACCOMPLISHMENTS 2009 PLANS.
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.