About the Program
The Plant Breeding Innovation Management Program is a global management platform that empowers the development, utilization, deployment, and adoption of plant products created through advanced breeding techniques, such as genome editing in agriculture. The Program outlines a set of management activities for the development, use, and introduction of products of PBI that could be developed using conventional breeding methods or have characteristics of conventionally bred plants (e.g., found in nature). Importantly, the Program consists of activities and considerations that should be part of an organization’s research, development, and commercialization activities as applicable to their operations.
Key Tenets of the Program
• Flexibility: The program provides flexibility for activities based on the organization’s assessment of its products, intended uses, potential markets, applicable regulatory requirements, and potential stakeholders and value chain members.
Program Design
The program consists of activities that align with the key tenets of the program and are designed with all sizes and types of organizations in mind. The Components are outlined in two sections: 1) Core Components which apply to all participants and include a core set of product and quality considerations; and 2) Conditional Components which are applicable based on an Assessment of internal operations and include four subsections focused on potential impact areas. These include: A) regulatory environment; B) plant characteristics; C) market scope and trade considerations; and D) stakeholder/value chain transparency and engagement. For conditional components, only those relevant to an organization’s operations would be expected to be developed, implemented, and verified. The core components, and the applicable conditional components based on the assessment, are confirmed through an independent verification process.
Core Components
This includes a core set of product and quality considerations that comprise basic management activities to be implemented and verified for all program participants. The core components include actions relating to documentation, training, and maintaining plant product integrity. Importantly, this section is not intended to be prescriptive. Organizations of any size and complexity will develop and implement these activities based on their own operations, business objectives, and organizational needs.
Conditional Components
This is a set of required accompanying actions contingent upon the assessment of an organization’s activities as it utilizes PBI. This section is fit for purpose and scalable to meet the complexity, size, and scope of participating organizations, their use of PBI, and as appropriate their products. The assessment is a set of evaluative, principal-based questions designed to assist an organization in developing and implementing appropriate activities based on the utilization of PBI methods in developing products, the regulatory environment in the country/region(s) of development and commercialization, nature of crop utilized, market scope, and value chain and stakeholder feedback. Using the assessment, a set of applicable conditional components are identified by the participant to implement from research and discovery through commercialization operations as appropriate. Those additional activities would integrate into and strengthen existing quality systems. This assessment should be conducted at the timing and level most appropriate to your organization’s operations. It is recommended to be done at the beginning of the research and development process, or when a PBI derived plant product may be integrated into your product pipeline, so timely decisions and actions specific to the product’s development and intended use can be taken. Organizations should conduct activities based on specific characteristics and intended use of the product after an initial assessment and then reassess its management approach/plan as deployment or intended use is determined. If assumptions or inputs to the assessment change, an additional assessment must be completed.
Verification Process
Program participants commit to an independent third-party verification of the implementation of management programs and quality management activities consistent with the objectives of the program. A Verification Guide will be developed to provide guidance to program participants undertaking these verifications. The verification is at an organization level and each program participant will work with their verifier to determine the sites/operations which will need to be included in the verification process. These will include headquarters and additional sites related to plant breeding innovation work that may be relevant to the program. The verifier will verify and document, by examination of objective evidence, if the organization has established and implemented appropriate measures consistent with the program objectives. An organization level verification is systematic and independent; verifying by examination of processes that applicable elements of the system are appropriate, documented, and implemented in accordance with program objectives.