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Frequently Asked Questions

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General | Membership | Audits | Resistance Management | Resources


General

Q. What is Excellence Through Stewardship (ETS)?
A. 
ETS is a global industry-coordinated organization that promotes the universal adoption of stewardship programs and quality management systems for the full life cycle of plant product production. Click here to view our Mission Statement.

Q. When was the Excellence Through Stewardship organization created?
A. 
In order to support industry efforts for the responsible management of it biotech plant products, ETS was created in 2008 by 11 organizations involved in the research and/or production of plant products. The idea of good product stewardship was not new as many of these practices were implemented when the very first products were commercialized. However, the creation of ETS as a global organization focused the industry’s efforts into a worldwide set of best management practices. The first round of audits were performed in the United States during 2008-2009 and expanded to include global operations in 2009-2010.

Q. What are the objectives of the ETS program?
A. The objectives of ETS are to:

Maximize technology benefits

Promote responsible use of technology for food, feed and environmental safety

Support full compliance with applicable regulatory requirements

Actively engage with the food value chain to evaluate and promote appropriate stewardship approaches

 

Q. What are the focus areas for ETS?
A. There are three major components:

Principles and Management Practices;

Guides to Understanding and Implementing Stewardship and Quality Management Systems; and

A Global Stewardship Audit Process.

 

ETS provides training and resources in these areas to advance its mission of promoting responsible management of agricultural technology by developing and encouraging the implementation of product stewardship practices.

Q. To what types of products do the components of ETS apply?
A. Each of the ETS components applies to agricultural technology-derived plant products that have the potential to enter the food or feed supply, including, but not limited to, commodity crops, specialty crops, energy crops, perennials, ornamentals, plant-made pharmaceuticals and plant-made industrial products.

Q. Do the components of ETS just apply to the United States?
A. No. The ETS organization and its members are committed to promoting and implementing the program globally. The ETS organization encourages companies, research and academic institutions and technology supporters from around the world to join.

Q. How do the various components of Excellence Through Stewardship complement regulatory compliance?
A. 
They aim to strengthen and support full regulatory compliance through the requirement to have a management system in place for these and associated activities. The ETS audit process does not replace internal or external audits seeking to confirm regulatory compliance and/or the effectiveness of processes and systems, but the third-party audits conducted under the ETS process do verify that stewardship programs and quality management systems are in place to achieve regulatory compliance.

Q. How does ETS enable and align with member stewardship programs and quality management systems?
A.  
The ETS guides provide a foundation for understanding and implementing these programs and systems. All aspects of ETS integrate with and can complement other initiatives and audits (e.g., ISO or GLP) to help provide a comprehensive approach to stewardship and quality management.

Q. How do ETS and the USDA Biotechnology Quality Management System (BQMS) efforts align?
A.  
Both are voluntary programs with defined requirements for participation, including commitment to an audit process involving qualified auditors. While they are separate organizations, there is regular communication between the groups which helps ensure alignment on the process and procedures of audits of confined field trials. Each organization also maintains additional unique process considerations.

Membership

Q. Who can become a member of ETS?
A. 
Membership is available to organizations engaged in discovering, developing, handling or commercializing biotech plant products. This includes technology companies, academic institutions, public and private research organizations, seed producers, licensees and other service providers to the industry.

Q. What are the benefits of ETS membership?
A.
 There are multiple benefits, including:

Access to technical resources and expertise

Enhanced/improved product stewardship

Networking opportunities

Recognition

Flexibility of ETS program structure

 

Q. How is ETS membership structured?
A.
 
There are two types of ETS members:

Regular members

Associate members


Members have the opportunity to engage in ETS efforts by participating on various ETS committees.

Q. What commitments are made by members upon joining ETS?
A.  Members of ETS adopt a wide array of principles and management practices in support of the ETS mission. They include:

Define and document stewardship programs and quality management systems, for the full product life cycle.

Implement a third-party audit process that follows approved ETS audit protocols and verifies that stewardship programs and quality management systems are in place.

Include, in applicable contracts and agreements involving plant biotechnology with third parties, stewardship and quality management requirements, practices or specifications that are consistent with the Stewardship Objectives, Principles and Management Practices.

Reach out to others involved in the development and production of biotechnology-derived plant products, with whom relationships have been established, to promote stewardship programs and quality management systems.

Engage others in the food, feed, fiber and energy value chain, with whom relationships have been established, to promote stewardship programs and quality management systems.

 

Q. How does my organization join ETS?
A. 
Click here for information on how to join.

Q. Whom do I contact for information on membership fees and application?
A. 
Contact Chris Holdgreve, Executive Director.

Audits

Q. How are ETS audits conducted?
A. 
Third-party audits are conducted at a systems level, at specified intervals organized by and at the expense of, member companies. ETS-trained auditors examine objective evidence for each of the ETS elements relevant to an organization’s operations.

Q. What is meant by a systems audit?
A. 
A systems audit verifies that the member organization has established quality management systems consistent with ETS objectives, principles and management practices.

Q. What portions of a member’s operation are audited?
A. 
Independent auditors confirm that a member’s stewardship programs and quality management systems in support of ETS objectives, principles and management practices are in place through on-site audits at global or regional headquarters and by audits at additional research laboratory, containment facility, field trial and seed production sites, as applicable.

Q. How many audits have been conducted and where?
A. 
Through the first four years of the program, more than 175 audits were conducted across 28 countries.
Additional information on the ETS Audit Program can be accessed on the Audit Process page of this website.

Q: The ETS Audit Checklists include “verbal evidence” as an objective evidence option for many of the audit questions – does this mean that for these questions we would only need to supply verbal evidence to satisfy the auditor as they make a determination?
A: In nearly all cases the answer would be no. For our program verbal evidence means an employee’s response to an auditor’s question that demonstrates the employee’s knowledge and understanding of the quality management system requirement and its implementation. This is generally a supporting piece of evidence that combines with others – such as Standard Operating Procedures (SOPs) or work instructions – so that an auditor can make a positive determination that the organization has documented a process or procedure and that it is being implemented.

Resistance Management

Q. What is the purpose of the Guide for Resistance Management?
A.  To provide guidance on the development and implementation of resistance management plans for traited products as components of an Integrated Pest Management strategy throughout the product life cycle. The Guide initially focuses on Insect Resistance Management (IRM). A Herbicide Resistance Management section is currently in development.

Q. What is Integrated Pest Management (IPM)?
A. A holistic approach to sustainable agriculture that focuses on managing pests (e.g., weeds, insects) using a combination of sound agronomic best management practices (i.e., cultural, biological, and chemical methods) that minimizes pest damage and maximizes the availability and longevity of tools needed for pest management.

Q. What are some key components to be considered in Integrated Pest Management and resistance management strategies?
A. They include:

Preventing the development of resistant  pests

Preserving natural enemies within the cropping system (e.g., insect predators)

Monitoring crops for pests and natural control mechanisms

Intervening when additional control measures are needed

Using multiple complementary control tactics

 

Q. What are some of the activities the IRM section of the guide recommends to organizations engaged in the development and commercialization of insect protected products?
A.  The Guide recommends trait developers and licensees have processes and procedures in place for:

Conducting resistance risk assessments during product development for particular crop/insect control trait(s) combinations for intended geography(ies);

Developing appropriate product- and geography-specific resistance management plans;

Implementing IRM plans in a transparent manner;

Ensuring availability of appropriate refuge seed

Training stakeholders, including growers

Promoting farmer adherence to IRM guidelines; and

Investigating and managing potential field resistance situations.

 

Q. How should this guide be used by organizations involved in the development and/or commercialization of insect protected products?
A. The IRM section of the Guide is broken down into modules [Risk Assessment, IRM Plan Development, IRM Plan Implementation and IRM Program Maintenance and Compliance with IRM Requirements] which outline potential timing for the associated activities.

Q. What is the scope of the guide and where in a product’s life cycle does this guide make recommendations?
A. The IRM section of the Guide addresses items to consider in developing and commercializing biotechnology-derived plant products including assessment of the potential for resistance to the trait (e.g., insects are no longer controlled by the trait). Development of plans for incident response, resistance monitoring, and resistance mitigation are also included. Because resistance decreases the utility and sustainability of the trait, IPM plans/programs should have a global framework with the flexibility for regional and local considerations and implementation. The Guide suggests steps that can be taken as early as product conception through post commercialization activities.

Q. Who helped produce the guide?
A.  The development of the Guide was a collaboration between ETS and CropLife International’s Insecticide Resistance Action Committee and Plant Biotechnology Product Stewardship Project Team.

Q. In what languages is the Guide offered?
A.  The Guide is available in English, Portuguese and Spanish with Chinese, French and Vietnamese to be added in the coming weeks

Q. Is there also an ETS IRM Audit Component and how does this component impact ETS member commitments?
A. Yes, there is an ETS IRM Audit Component. When applicable, member organizations will include the new component in their overall ETS audit program commitments.

Q. What is the scope of the ETS IRM Audit Component?
A.
 ETS auditors will verify member companies have processes and programs for IRM in place, including:

Management accountability

Addressing applicable regulatory requirements

Developing and implementing product-specific IRM plan

Implementing market deployment and IRM awareness strategy

Implementing compliance programs

Implementing resistance monitoring

Handling reports of potential resistance

Records and documentation

 

Q: Will the program audit growers?
A: No.

Q: What is the timeframe for implementing the IRM Audit Component?
A
: The timeline for implementation (only applies where applicable to an organization’s operations) of the ETS IRM Audit Component:

Audits Conducted in Argentina and Brazil by October 1, 2015

Audits Conducted in U.S. plus one additional global region by December 31, 2016

ETS Audit Summary Reports submitted to ETS for Argentina, Brazil, U.S., plus selected additional region by December 31, 2016.

 

Q: How does the Audit Component apply to licensees?
A: Licensees of insect protected traits are still responsible for implementing the ETS IRM Audit Component. However, since they are not the trait developer they may not be responsible for every question from ETS IRM Audit Checklist. For example some activities related to Module 1: Risk Assessment may have been completed by the developer and would not need to be duplicated by the licensee. The developer and licensee should be aware of stewardship related activities conducted for product specific IRM traits that each would need to complete. For specific questions regarding applicability of certain requirements please contact the ETS office directly at info@excellencethroughstewardship.org.

Q: Do all four modules need to be implemented for Brazil and Argentina?
A: Yes, all four modules need to be implemented for Brazil and Argentina. Since there are already products on the market in these, and other geographies, risk assessments have already occurred and IRM plans already developed and implemented. Given this situation we understand that some of the ETS IRM Audit Checklist questions may not be relevant for all current conditions. However, with the development of this new component for ETS and the efforts being undertaken within the industry in these countries we would expect that aspects of each of the modules will be relevant. For specific questions regarding applicability of certain requirements please contact the ETS office directly at info@excellencethroughstewardship.org.

Q: What about companies/organizations that only have products in development and not yet commercialized – when do they need to have their audits completed?
A: Every member organization that has or is developing insect protected traits must implement the ETS IRM Component. Those with products currently on the market and with an audit cycle ending December 31, 2016 must complete initial audits in Brazil and Argentina by October 1, 2015 and then in the U.S. plus one additional region by December 31, 2016. All four Audit Summary reports are to be submitted to the ETS office by December 31, 2016. All others should contact the ETS office to discuss their IRM implementation requirements.

Q: The ETS Audit Checklists include “verbal evidence” as an objective evidence option for many of the audit questions – does this mean that for these questions we would only need to supply verbal evidence to satisfy the auditor as they make a determination?
A: In nearly all cases the answer would be no. For our program verbal evidence means an employee’s response to an auditor’s question that demonstrates the employee’s knowledge and understanding of the quality management system requirement and its implementation. This is generally a supporting piece of evidence that combines with others – such as Standard Operating Procedures (SOPs) or work instructions – so that an auditor can make a positive determination that the organization has documented a process or procedure and that it is being implemented.

Q: How are sites for audits chosen?
A: The ETS Audit Process outlines an organizations requirements for implementing the ETS program. Specific sites however are chosen by the member as part of their audit plan.

Resources

Q. What resources are available to non-members?
A. ETS website with detailed information on the program, Implementation Guides and outreach opportunities (e.g., workshops, conferences and stakeholder dialogues)

Q. What additional resources are available for members?
A. Training materials, checklists, presentation tools, self-assessment tool and networking opportunities

Q. Where can I get additional information?
A. In addition to the ETS website, a number of links to external information on ETS member companies, agricultural organizations, government regulators and international organizations related to biotechnology can be found on the Resources page of this website.

Q. How do I get more program information?
A. Click here for contact details.

 

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