Canadian Food Inspection Agency
Animal Products Direcorate
Animal Health and Production Division
Feed Section

Revisions to Regulatory Directives Dir94-08 “Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits” and Dir95-03 “Guidelines for the Assessment of Livestock Feeds from Plants with Novel Traits”

The Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency (CFIA) is responsible for regulating the release of plants with novel traits (PNTs) into the Canadian environment, while the Feed Section, CFIA, regulates novel feeds, which include livestock feed derived from PNTs. The guidance for criteria to be considered in the assessment of safety of a PNT and a novel feed is outlined in CFIA’s Regulatory Directives Dir94-08 “Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits” and Dir95-03 “Guidelines for the Assessment of Livestock Feeds from Plants with Novel Traits.”

The PBO and the Feed Section have updated their Regulatory Directives Dir94-08 and Dir95-03 to reflect advances in knowledge and technology. In keeping with the CFIA's commitment to openness and to public involvement, the CFIA convened a consultation on May 29-31, 2002 to solicit expert and stakeholder input on proposed revisions to CFIA’s Dir95-03 and Dir94-08. In addition the draft revisions of Dir94-08 and Dir95-03 were posted for public comment on the CFIA web site from May 27 to July 25, 2003. From this consultation process comments were received from individuals, farmer's organizations, industry, academia, public interest groups, consumers associations, trade organizations, and government research and regulatory bodies. Comments and recommendations from the respondents on the draft revisions of Dir94-08 and Dir95-03 have been carefully considered and have contributed to the final version of Dir94-08 and Dir95-03. The PBO and the Feed Section have worked together to harmonize their guidelines particularly in the areas of definitions, molecular characterization requirements and novelty triggers. Please note that the title of Dir95-03 has been changed to “Guidelines for the Assessment of Novel Feeds: Plant Sources.”

Dir94-08 and Dir95-03 incorporate current knowledge and will be updated as appropriate to encompass developments as they arise.

The CFIA replied directly to authors who submitted written comments during the consultation period. Several common themes emerged from the comments received. These areas of common concern are discussed below.

Inclusion of products of conventional breeding in the definition of PNTs and novel feeds.

Several respondents questioned why CFIA regulated the product not the process.

It is the presence of a novel trait in a plant that triggers regulatory oversight, not the method used to introduce the trait. Hence the plant rather than the process is subject to regulatory oversight. As such, PNTs and novel feeds may be created by such methods as traditional breeding, mutagenesis, cell fusion, or recombinant DNA techniques. The CFIA conducts science-based assessments of PNTs and novel feeds before they can be released into the environment, or used as livestock feed, regardless of the method of creation. This product based approach was recommended as early as 1988, during a consultation with researchers from industry, academia, federal and provincial governments. This approach has been endorsed by the Federal Regulatory Framework for Biotechnology, approved by the Government of Canada in 1993, and has been validated by numerous scientific bodies. Indeed, novel traits with potential significant impacts on natural and managed ecosystems, such as herbicide tolerances, can be obtained by traditional breeding techniques, mutagenesis or genetic engineering. The Canadian regulatory system ensures that all PNTs and novel feeds are subject to a safety review before their release into the environment or use as livestock feed.

Novelty

Clarity was requested on what constitutes novelty and regulation by the CFIA.

What if a trait is novel but poses no risk?

Plant breeders and product developers are encouraged to consult with the PBO, the Feed Section and the Novel Foods Section (Health Canada) in the early stages of development to determine the novelty of their products. The novelty of a product is assessed by the developer based on the characteristics of the novel trait in comparison to the trait(s) present in stable, cultivated populations of the plant species in Canada as well those products already in the market in Canada. Novelty of a modified plant is determined on a case-by-case basis. In general, a trait would be considered novel when it is present at a level outside the accepted range of variation for that trait based on Canadian experience. It is the responsibility of plant breeders and product developers, based both on their expertise and relevant scientific literature reviews, to determine the range of the selected trait in current crop cultivars for the plant species in Canada. Substantive changes in agronomic, nutritional and compositional characteristic(s) of a plant that are outside the accepted range of variation for a given species, based on Canadian experience, would trigger regulation.

In order to provide additional clarity regarding what constitutes novelty, with regard to regulation as novel plants or feed, further guidance on novelty was incorporated in Dir94-08 and Dir95-03. Guidance was provided on intra-specific and inter-specific crosses, intentional trait stacking and re-transformation/re-mutation. The CFIA also held a separate consultation on novelty in March 2004. The CFIA will continue to work with developers and plant breeders to continue the novelty discussion.

The trigger for regulation as a PNT or a novel feed is novelty, not risk. While there may not be an apparent risk associated with a particular PNT or novel feed, a given novel product is not familiar or substantially equivalent to what is currently in use in Canada and this triggers a safety assessment. The assessments are performed on a case by case basis and based on valid scientific rationale certain studies outlined in the guidelines can be waived if they are not appropriate.

Detection and Identification:

Clarity was requested on what methodologies and reference material would be required. Additional information was also requested regarding the use of this information.

In order to accommodate the broad range of PNTs/novel feeds that are developed and submitted for approval in Canada, guidance regarding the appropriateness of test methodologies for detection and identification is flexible and determined on a case by case basis. Suitable methods may be protein, RNA or DNA based. Phenotypic based methods will not be considered suitable detection methods if they can’t detect and identify a PNT in a sample of seed and non-viable grain, or other single ingredient feed. CFIA has provided guidance regarding acceptable detection and identification methods for PNTs and livestock feeds derived therefrom. The CFIA recommends that plant breeders and developers consult with the PBO and the Feed Section prior to submission to determine suitable detection methods and reference materials. As with all data provided in a PNT submission, the PBO and the Feed Section will evaluate each detection method and related reference material on a case-by-case basis. The CFIA recognizes that some of the information submitted on detection and identification is considered as confidential business information by the applicant and this information will be treated accordingly. The information on detection and identification will be used to support PBO and Feed Section compliance needs, where appropriate. A decision on approval for unconfined environmental release or livestock feed use of a PNT/novel feed will not be granted until appropriate detection and identification tools are submitted to the CFIA.

Confidential data provided to the CFIA

Comments were received questioning how confidential business information was treated by the CFIA.

Confidential business information is protected under the federal Access to Information Act, section 20. Information that is deemed to be confidential under this Act will not be released to third parties. If a request is received for information (e.g., Access to Information and Privacy Request, ATIP) the Access to Information and Privacy Section, CFIA, will consult with the owner of the information, to determine what information is confidential. Material deemed to be confidential will not be released to a third party.

Transparency

The regulatory process for the assessment of PNTs was criticized as a closed process. Comments were received that there should be opportunity for public comment on PNTs undergoing safety assessments.

The CFIA recognizes the value of increased transparency in the regulation of PNTs and novel feeds. Currently, the CFIA posts lists of all approved PNTs and novel feeds derived from PNTs that are approved in Canada on the CFIA Web site, along with the accompanying decision documents. In addition, the CFIA and Health Canada (HC) launched a pilot project entitled "The Biotechnology Notices of Submission Project", on October 21, 2003. The objective of this project is to increase transparency in the regulation of PNTs, novel feeds and novel food products by notifying the public, through the intermediary of the CFIA Web site, of all PNTs, novel feed and novel food products under review by the Government of Canada. These submission notices will describe the novel product and summarize the information provided to the federal government by the applicant for its safety assessment.

Member companies of CropLife Canada, the trade association representing developers of biotechnology-derived plant products for use in agriculture, have volunteered to provide this information to Canadians in the form of a "notice of submission". Please note that this project is voluntary since there are no requirements within the acts and regulations administered by the CFIA and HC which stipulate that developers must make information regarding their submissions available to the Canadian public. The public will also be given the opportunity to voice their comments and concerns as well as to provide scientific inputs relevant to the safety assessment of all PNTs, novel feeds and novel food products for which a "notice of submission" has been posted on the CFIA Web site.

This pilot project supports the Government of Canada's commitment towards a greater openness and increased transparency regarding novel product information and is in response to the recommendations made by the Royal Society of Canada's Expert Panel report entitled, "Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada". The objective of this pilot project is to increase transparency in the regulation of novel crops, novel feed and novel food products and is also consistent with advice given to the Government of Canada by the Canadian Biotechnology Advisory Committee (CBAC) in their report on the regulation of food biotechnology.

Additional Comments on the Revision of Regulatory Directive Dir94-08: “Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits”

The following addresses additional comments expressed by several respondents for which the PBO felt it was appropriate to provide a generalized answer.

Role of the Pest Management Regulatory Agency (PMRA) during the evaluation process of PNTs

Several respondents requested clarity on PMRA involvement during the evaluation of an unconfined environmental release application.

During the evaluation of an unconfined environmental release application for a PNT expressing altered pesticidal tolerance or altered pesticidal properties, the PBO may solicit the scientific expertise of Health Canada’ PMRA with respect to the environmental safety of such a PNT. As such, the PBO will share applicant information with PMRA on a “need-to-know” basis only. The PBO, and not PMRA, is responsible for carrying out the environmental safety assessments or regulatory reviews of PNTs with altered pesticidal tolerances or properties. In addition, other scientific experts may also be consulted by the PBO with regards to specific scientific issues when conducting an environmental safety assessment of a PNT. Solicited advice, given by either PMRA or other consulted scientific experts, will be considered by the PBO in the final evaluation of the PNT for unconfined environmental release. Where registration of a pest control product is mandatory, it is the applicant’s responsibility to meet all the requirements of the Pest Control Products Act, an act which is administered by PMRA. PMRA is the federal agency responsible for conducting the appropriate risk and value assessments of pest control products in Canada. Applicants may wish to refer to the Registration Handbook for Pest Control Products as a detailed reference guide for the registration process.

The PBO continues to work with PMRA to consider strategies for the safe and effective use of herbicides and herbicide tolerant crops in Canada. Safety issues associated with pesticide use are solely the authority of the PMRA. Safety issues arising from the application of new herbicides on plants expressing novel herbicide tolerance(s) are assessed in collaboration with PMRA.

Insect Resistance Management

Some respondents recommended that the Agency does more to publicize the necessity and importance of refugia, while others disagreed that IRM plans should be mandatory for all plants with insect resistance, especially if the novel protein is not the same used as in commercial products.

IRM plans are intended to significantly reduce or delay the development of resistance in insects to the expressed novel compound in crops. The poor deployment of insect resistant crops could result in the early development of insect resistance and rapid loss of that technology’s utility. As part of its environmental safety assessment, the PBO will consider the impact of a PNT on agro-ecosystem sustainability. The development of resistance in insects to novel compounds due to the non-adoption of effective IRM plans could have significant implications on sustainable agriculture if more growers lose the use of less toxic management tools. This is particularly important if insects develop cross resistance to a plant expressing a pesticide as has been seen with some Bt products.

A stewardship plan to address IRM strategies must be included in the application for unconfined environmental release. Communication to growers and seed distributors is an integral component of the stewardship plan and as such, part of the developer’s responsibility is to ensure that educational tools on IRM strategies are developed and provided to growers, district managers and field managers. Other essential components of the stewardship plan include close monitoring of crop fields for the presence of resistant populations of insects and the development of mitigation measures in the event resistant populations are identified.

Herbicide tolerance management (HTM) and stewardship

The PBO received several comments on the nature (voluntary or mandatory) of the HTM stewardship plan. Some respondents suggested that the implementation of the HTM stewardship plan should be voluntary and industry-led, while other respondents felt that the stewardship plan should be a condition of unconfined release.

The PBO recognizes that the development and implementation of stewardship plans for herbicide tolerant (HT) crops should be industry-led. In addition to being responsible for the development and implementation, applicants will also be held accountable for the monitoring of the effectiveness of their stewardship plan and making any appropriate changes to the plan as required. The plan should include appropriate strategies that will allow the deployment of the new HT crop so that it may be environmentally safe and sustainable. In addition, communication to growers and an efficient mechanism that enables growers to report problems to the developer are also integral to the stewardship plan.

The PBO will evaluate, as part of its environmental safety assessment, stewardship plans for new HT crops. Stewardship plans will now be part of the required information for determining environmental safety and applicants will be asked to describe, in detail, their stewardship plans in their unconfined environmental release submissions. Environmental concerns that should be addressed in stewardship plans include, but are not limited to, any negative effects associated with significant changes in agronomic practices as well as volunteer and weed management issues associated with the cultivation of the new HT crop. New HT crops will not be authorized unless issues surrounding potential changes in agronomic practices are addressed in a manner that is consistent with sustainable agricultural practices.

Post-release monitoring plan

Some respondents suggested the PBO provide further guidance on what elements should be included in a post-release monitoring plan to detect unintended or unexpected environmental effects.

Applicants are required to provide a suitable post-release monitoring plan, which will be evaluated, as with all data provided in an unconfined release submission, on a case-by-case basis. Applicants are required to use appropriate indicators and parameters that will be based on the characteristics of the PNT. The use of appropriate baseline data to detect unintended or unexpected environmental effects of the PNT after its release in the environment must also be considered in the monitoring program. The PBO will only authorize the release of a PNT until an acceptable post-release monitoring plan has been proposed by the applicant.

Approval process

Clarity on what is meant by “interim approval” and “make this information available to other stakeholders” was requested.

“Interim approval” is a “time-limited approval.” Time-limited approval will be granted in cases where a PNT is assessed to be safe, but where a follow up with the applicant for additional information is required in order for proper implementation of a specific management plan (e.g., new insect resistance management plan). For instance, the PBO may grant a time-limited approval for the unconfined environmental release of a PNT expressing novel insect resistance, when the ability of a developer to fully research on a proposed IRM plan is restricted due to the limitations in size of the confined field trials. The applicant will be notified of the required additional information by a deficiency letter. Renewal of the time-limited approval is contingent upon the submission of adequate study reports, and/or demonstration of significant progress in research related to the PNT. An indeterminate authorization may only be granted when the applicant has submitted all the information the PBO deems necessary to complete its environmental safety assessment.

The CFIA posts a list of all approved PNTs and novel feeds from PNTs on its Web site, along with the accompanying decision documents. In addition, the PBO will also inform, where appropriate, other federal authorities, such as Environment Canada, as well as designated provincial authorities of any new approval granted for the unconfined environmental release of a particular PNT.

Required information on the Biology and Interaction of the PNT

Further clarifications was requested on what are acceptable environments for confined research field trials and the meaning of “representative” of the normal growing conditions.

Confined research field trials of PNTs should take place in the intended growing regions of the PNT in Canada in order for information and data collected during these trials to accurately reflect the novel plant’s behavior in its surrounding environment. Data collected from field studies outside of Canada can be used if the applicant demonstrates that the environment for testing the PNT is similar to the Canadian environment. In cases where there may be a potential for increased weed characteristics or if the plant is an outcrossing species, it may be considered appropriate to also evaluate the novel plant’s behaviour outside of its managed ecosystem(s).