Member Frequently Asked Questions

See Glossary for definitions and abbreviations. 

 

Audit

 

Q. How are ETS Stewardship Program audits conducted?

A. External-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 and does not verify the effectiveness of processes and systems.

 

Q. What portions of a regular member’s operation are audited?

A. Independent auditors confirm that a regular 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 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: 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.

 

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

 

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: Does the program audit growers?

A: No.

 

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.

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