Assessment criteria for determining environmental safety of plants with novel traits.

  • Canada. Interdepartmental Executive Committee on Pest Management.
Date:
1994
Catalogue details

Licence: In copyright

Credit: Assessment criteria for determining environmental safety of plants with novel traits. Source: Wellcome Collection.

    6/30 (page 2)
    A2.0 The authorizations have taken into consideration potential risks and, depending on these risks, applicants are required to take steps to mitigate potential problems. Regulated trials will continue but some PNT’s will be eventually considered for open or unconfined release into the environment, towards the time of commercialization. Before PNT’s may by authorized for unconfined release they must be assessed for environmental safety. This document addresses the information necessary to identify potential adverse environmental impacts associated with the unconfined release of the Environmental Protection Act (CEPA), and amendments to the Seeds Regulations (Part V). Specific information requirements will vary with the species, characteristics of the novel trait and the PNT’s end use. The information must address three issues: e identity of the PNT, e relative phenotypic expression, and ¢ potential interactions of the PNT with other life forms. It should be noted that this is a federal regulatory document. The appropriate provincial regulatory authorities are being consulted to ensure a “single window” approach and harmonization of regulations. Scope and Purpose A2.1 The scope of this document covers all plants with novel traits that are of concern (i.e., that are not familiar or substantially equivalent to products already on the market, in use and generally regarded as safe). A2.2 The purpose of this document is to define criteria and information requirements that must be considered in the environmental assessment of PNT’s to ensure safety, in the absence of confinement conditions. This includes identification of potential concerns, required information, and procedures to assess potential environmental impacts associated with unconfined release of PNT’s. The assessment Criteria are designed to be used in conjunction with species-specific companion documents, that describe the biology of the species to which the modified plant belongs, including details of other life forms with which it interacts. The assessment will be part of the continuum of research, development, evaluation and commercialization of plants with novel traits (Appendix I, Figure 2). Regulatory Directive - Dir94-08