Report of Stakeholder Comments on Proposed Revisions to Health Canada's Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms and Health Canada's Response to These Comments

Background and Context

The Food Directorate conducted a 75-day (July 15, 2003 - September 30, 2003) online public consultation on the proposed revisions to the Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms (June 2003 revised version). These guidelines provide guidance on safety assessment with respect to Division 28 of Part B of the Food and Drug Regulations (Novel Foods). This consultation continued the dialogue initiated during the Joint Consultation on the Revision of the Regulatory Directives and Guidelines for the Assessment of Novel Foods, Plants with Novel Traits¹ and Livestock Feeds derived from Plants with Novel Traits hosted by Health Canada and the Canadian Food Inspection Agency (CFIA) in Gatineau, Quebec, on May 29-31, 2002. Notification of the online public consultation was sent to various stakeholders by mail. The Food Directorate also invited members of the public to participate in the consultation via its novel foods website ( http://www.novelfoods.gc.ca).

A three-part document was created to help solicit comments from the public during the consultation. Part I of the document, entitled "Regulating and Assessing Novel Foods", provided background information on various sections of the revised guidelines and highlighted the areas where the Food Directorate was most interested in receiving feedback. Part II of the consultation document, entitled "Looking Forward", covered issues related to the general context under which novel foods are regulated in Canada, including the coordination of regulatory decisions between Health Canada and the CFIA, proposals to increase transparency and create more opportunities for providing input into decisions related to novel foods, and technical issues such as the use of antibiotic resistance marker genes. Part III of the document, entitled "Foods Derived from Cloned Animals", provided background information and sought input on the regulation of foods derived from animals generated using the cloning technique of somatic cell nuclear transfer.

Each part of the document contained points of consultation for which input was solicited and comments were received. Comments related to Part I have been used to refine the revised guidelines, while comments related to Parts II and III, will be used to develop and refine policies in the area of novel foods and food biotechnology.

Twenty-five respondents submitted comments in response to the public consultation, although not all participants responded to all of the points of consultation. Those responding included academia, health professional organizations, members of the public, federal and provincial agencies, a consumer advocacy group and organizations representing industry including growers, manufacturers, importers/exporters, distributors and retailers (associations as well as individual organizations).

Changes were made to the guidelines in response to concerns and suggestions expressed by stakeholders. Some highlights include:

• More information on the application of the timelines for completing safety assessment set out in the regulations on novel foods (Section 2.5);
  
  
• Additional details on how the Canadian Food Inspection Agency and Health Canada work together in the regulation and safety assessment of novel foods derived from plants with novel traits (Section 3.2);
  
  
• An expanded decision tree that provides more clarification on regulatory triggers (Figure 3);
  
  
• Further elaboration of information requirements for foods derived from or produced using genetically modified microorganisms (Section 4.2.3.2).

A more detailed summary of the comments received in response to the online consultation and the Food Directorate's response to these comments follows below. Similar concerns/suggestions were raised in comments to different points of the consultation and, where applicable, the Food Directorate response to these points has been combined.

¹ The proceedings of the consultation and a summary of comments received from the web-based forum are available at: http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_novel_foods_and_ingredient.html.

Part I - Regulating and Assessing Novel Foods

The purpose of the regulations on novel foods is to ensure that the safety of all novel foods entering the Canadian marketplace has been assessed by Health Canada prior to marketing. The purpose of the revised guidelines is to clarify which foods require pre-market notification, to detail the information that must be submitted to Health Canada and to define the relevant timelines.

Comments regarding the determination of novelty.

Summary of comments received:

Several of the comments suggested that the guidelines should elaborate on the responsibilities of Health Canada and the Canadian Food Inspection Agency (CFIA) and the organizational relationships between them. Some comments also suggested that the text of the Food and Drug Regulations pertaining to novel foods should be included in the guidelines. Received comments also suggested changes to the definition of novel foods in the Food and Drug Regulations or further explanation of some of the terms used in the novel food definition (eg., heritable trait, intentional manipulation, characteristics, major change). It was also suggested that the web site addresses of relevant organizations (eg., CFIA, Organization for Economic Cooperation and Development, Food and Agriculture Organization) be provided as part of the guidelines.

Food Directorate Response

In response to these comments, additional text has been added to the revised guidelines to clarify the responsibilities of Health Canada and the CFIA and to provide additional detail on how they work together in the regulation and safety assessment of plants with novel traits (sections 1.1 and 3.2). Additional text has also been added to clarify the organizational relationships within Health Canada and expand upon the role of Health Canada's Environmental Assessment Unit (EAU) with respect to novel foods (sections 1.2 and 3.1).

While parts of Division 28 of Part B of the Food and Drug Regulations (Novel Foods) were quoted in the earlier draft of the guidelines, for improved clarity and ease of reference, the whole text of the regulations has been placed in a text box in section 1 of the revised guidelines.

With respect to the suggested changes to the definition of novel food, it is important to note that the term novel food is defined in B.28.001 of the Food and Drug Regulations which is not open for revision at this time. To address the comments regarding the terms used in the regulations text has been added, where appropriate, to further aid in the interpretation of the novel food definition.

It was suggested that links to relevant organizations should be included in the guidelines. These links are currently provided on Health Canada's novel foods webpage ( http://www.novelfoods.gc.ca). To avoid problems of outdated addresses, the guidelines refer only to the novel foods website where other links can be found.

Summary of comments received:

Several comments touched upon the need to clarify how decisions are made regarding the determination of novelty, including information requirements that are needed to do this, and the time frames associated with pre-market notifications. Changes to Figures 1 and 2, including their placement in the text, were also suggested in order to improve the clarity of this section.

Food Directorate Response

To improve the information in the guidelines regarding the mandatory pre-market notification for novel foods and the determination of novelty, text regarding the pre-notification consultation which may take place between petitioners and the Food Directorate has been incorporated into the revised guidelines (section 2). In addition, a change has been made to what was Figure 1 of the guidelines (now Figure 3) so that it now highlights the pre-notification consultation. The Food Directorate encourages pre-notification consultations as they permit petitioners and the Food Directorate to discuss the data necessary to demonstrate the safety of a product. As well, the description of the intent of the timelines associated with novel food pre-market notifications has been improved. In addition, what was Figure 2 (now Figure 3) has been expanded to provide more clarification on when a pre-market notification may be required.

Summary of comments received:

Most comments indicated that the guidelines should provide more guidance with respect to novelty determination. Several comments indicated that examples of novel foods should be included in the guidelines to clarify the novel food definition. Comments regarding whether certain classes of products (eg. functional foods, herbal remedies, foods fortified with nutrients, irradiated foods) would be considered novel foods were also received. A comment recommending coordination between Health Canada and the CFIA in the criteria used to determine novelty was received in response to this point but will be addressed in the response to comments received on the concept of novelty as a trigger for pre-market notification. Several comments on the definition of "a history of safe use" were also received in response to this point and will be included in the discussion of 2b.

Food Directorate Response

To address the suggestion that examples of novel foods should be included in the guidelines, the novel food examples that are currently posted on the novel foods web site ( http://www.novelfoods.gc.ca) may be expanded to include additional examples of what is and what is not a novel food.

In addition, what was Figure 2 (now Figure 3) has been expanded to provide more guidance on regulatory triggers and should address questions regarding whether certain product classes (eg. functional foods, herbal remedies, foods fortified with nutrients, irradiated foods) would be considered as novel foods.

Health Canada has also been involved in activities to educate stakeholders on the determination of novelty. For example, on March 30 and 31, 2005, the CFIA and Health Canada hosted a workshop to seek input on potential tools and resources that would help clarify the regulatory trigger 'novelty' for the plant breeding community.

With respect to improving coordination between, the CFIA and Health Canada, the two regulatory bodies have developed a standard operating procedure (SOP) for plants with novel traits, which is now included in the revised guidelines.

Summary of comments received:

Several comments addressed the new definition of the concept of "history of safe use." While one respondent favoured 100-year time interval, others thought it was an unreasonable time frame. Other comments address the requirement to demonstrate safe consumption of a food in a "cross section of the population." One respondent thought that this was a reasonable suggestion, while others requested clarification on the size and diversity of the population and the amount of food that would have to be consumed. Respondents also sought further explanation surrounding the meaning of adverse effects and how they would be documented. Some of the comments received expressed concern about the effect that this definition would have on industry and other stakeholders including the CFIA and consumers.

Food Directorate Response

As a result of the comments received regarding the concept of a history of safe use and the 100- year time frame in particular, section 4.1.1.1 (history of use) has been modified to provide for more flexibility in the interpretation of this concept. In particular, the reference to the 100-year time frame has been removed. The time frame is now described as "a number of generations".

Comments regarding the assessment and final decision process.

Section 2.5 of the revised guidelines outlines Health Canada's standard operating procedures for conducting safety assessments and making final determinations regarding novel foods.

Summary of comments received:

Some comments received in response to points 1a, 1b, 2a and 2b were repeated in response to point 3a and will not be addressed here. Several respondents requested additional information on the review team, including how they are chosen and what their qualifications are, with one respondent indicating that the make-up of the review team should be transparent. Several comments related to the evaluation team's review (Is the review final? Is there an appeal mechanism for proponents? What happens in cases where not all members of the evaluation team are satisfied? How is it determined that enough data has been received?). Some of the respondents indicated that the use of external experts would strengthen the review process. This comment will be considered in response to Part II of the consultation document. The Food Directorate also received comments requesting clarification regarding the role of the Food Rulings Committee, and Canadian Environmental Protection Act (CEPA) 1999 requirements for the environmental assessment of novel foods.

Food Directorate Response

With respect to the make-up of the review team, as with all submissions that are reviewed in the Food Directorate, once a novel food submission has been distributed to a bureau, the management of that bureau determines who will be evaluating the submission. This is generally determined based upon the expertise and time resources of the evaluators.

With respect to the comments regarding the evaluation team's review, it is generally final unless new information comes to light. If there are concerns with a product, in most cases, the outcome of the safety assessment is not an outright rejection but rather a series of questions with unsatisfactory or no answers. If the outcome of a safety assessment is a rejection, then this is brought to the Food Rulings Committee. There is no formal appeal process but there is nothing preventing a company or other party from communicating their concerns to regulatory officials. The Food Directorate is always open to reviewing scientific information that is directly relevant to the decision made. There is no formal mechanism for determining when enough data has been received. It is essentially a question of determining if all pertinent questions have been answered satisfactorily and the evaluators ability to confidently draw conclusions regarding the safety and nutritional suitability of the food. If there is a need for resolution requiring senior management input, then the opinion of the Food Rulings Committee can be and has been sought.

With respect to the comments regarding the role of the Food Rulings Committee, text has been added to the guidelines to clarify that the final decision regarding the sale of a novel food rests with the Director General of the Food Directorate. The decision of the Director General is based on the summary of the scientific reviews that are presented for a novel food product and the advice of the Food Rulings Committee members. The Food Rulings Committee peer-reviews the safety assessments conducted by Food Directorate Bureaux and discusses relevant risk management options.

In response to comments received regarding clarification of the CEPA 1999 requirements for the environmental assessment of novel foods, the first paragraph of Section 3.1 of the draft guidelines has been replaced with one that better explains the requirements.

Summary of comments received:

There was some overlap between the comments received in response to points 3a and 3b. Comments which have already been addressed in response to 3a will not be repeated here.

A couple of respondents thought that this section should include information on the public disclosure of information from the results of the safety assessment process and public input into this process. One respondent suggested that in addition to the decision documents that are currently posted on the web, information sheets in plain language should be developed for the general public. Another respondent questioned the impartiality of the data supplied for review and suggested legislating specific tests that would have to be conducted on a product for it to be approved.

Food Directorate Response

Comments regarding public input into the safety assessment and the public disclosure of information relating to the safety assessment process will be dealt with as part of the response to Part II of the consultation document.

To address the comment regarding the plain language summary, the Food Directorate will consider adding such a summary to future Decision Documents (which are posted on the novel foods website) so that they are easier to understand for all Canadians.

The comment regarding the impartiality of the data seems to suggest that opening the study results to public scrutiny (increasing their transparency) would reduce the risk that the data provided is biased and not sufficiently rigorous. It is important to stress that the government receives in the submission, or upon request, the raw data. Paper reviews are a standard scientific method of evaluation used by regulators around the world, to evaluate the health and safety of a variety of products including food and drugs. Methods used by Health Canada are based on international expert consultations endorsed by the Codex Alimentarius Commission, World Health Organization (WHO), Food and Agriculture Organization (FAO), and the Organization for Economic Co-operation and Development (OECD).

Comments regarding the criteria for assessing the safety of a novel food

The revised guidelines describe the requirements for all three categories of novel foods: substances with no history of safe use as food, application of novel processes to existing foods and foods derived from genetically modified organisms. For the latter category, care was taken for the revised guidelines to reflect the risk analysis principles and safety assessment guidelines developed by the Codex Ad Hoc Intergovernmental Task Force of Foods Derived from Biotechnology².

Summary of comments received:

In general, many of the comments indicated that the guidelines contain enough detail on the information and data required for the safety assessments. Some comments suggesting modifications to section 4 were received, including the suggestion to state explicitly that unintended and intended effects are taken into consideration during the nutrition portion of the safety assessment and requests to elaborate on the information requirements for foods produced using genetically modified organisms. Another respondent suggested that the Pariza and Foster reference included in the revised guidelines should be removed. One respondent indicated that when Health Canada receives a submission, petitioners should be issued a letter of receipt indicating the timeline associated with the submission as well as a contact name.

General comments received on the clarity of section 4 of the guidelines are also included in the response to this point. Comments were received regarding the toxicological and allergenicity portion of the safety assessment particularly with respect to dietary exposure, the issue of low expression levels of novel proteins by plants produced using rDNA techniques, pepsin resistance assays, the testing regime of specific serum screening, the characterization of endogenous allergens and a request to clarify the strategy used to assess the potential allergenicity of novel proteins.

Food Directorate Response

The suggested wording changes to section 4 were considered and some of these have been incorporated into the guidelines. Text has been added to relevant parts of section 4 to indicate that the nutritional evaluation takes into consideration both intended and unintended nutritional effects.

Text has also been added regarding the viability and residence of microorganisms in the human gut, antibiotic resistance and genetic transfer to address requests to elaborate on the information requirements for foods produced using genetically modified organisms.

One respondent suggested that the following statement, " Since proteins that are enzymes have never been shown to be direct-acting carcinogens, mutagens, teratogens or reproductive toxicants (Pariza & Foster 1983)" should be deleted from the guidelines because it is not in line with the precautionary principle. This statement by Pariza and Foster is consistent with current scientific knowledge about the structural properties of proteins that are the basis for their biological activity and has been re-iterated in Pariza and Johnson, 2001 (Reg. Toxicol. Pharmacol. 33:173-186). The precautionary principle is invoked in cases where significant scientific uncertainty exists. Which is not the case in this situation.

In response to the suggestion regarding the issuing of letters of receipt when a submission is received, it should be noted that currently letters are mailed to petitioners by Health Canada upon receipt of a submission. The contact is the Chief of Evaluation Division, Bureau of Microbial Hazards, Food Directorate, who is the signatory of the letter of receipt and the letter also provides contact information to the petitioner if they have any questions.

With respect to the comment regarding dietary exposure, the problem of low expression levels of novel proteins by recombinant DNA plants has already been circumvented by inserting the same genetic sequence into microorganisms such as E. coli in order to produce enough of the protein for acute toxicity and in vitro digestibility assays. Another approach would be the establishment of thresholds of concern for toxic endpoints relevant to novel proteins. This has been problematic with respect to allergic sensitization and response, although work is progressing in this area.

With respect to the question regarding pepsin resistance analysis, the standardization of testing for in vitro digestibility was identified as a priority by the 2001 FAO/WHO Expert Consultation on Evaluation of Allergenicity of Genetically Modified Foods . The US FDA and industry partners collaborated on this undertaking through the International Life Sciences Institute (ILSI) and the Health and Environmental Sciences Institute. The work has been published as "A multi-laboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins" (Thomas et al. 2004; Regulat. Toxicol. Pharmacol. 39: 87-98).

With regards to specific serum screening, the testing regime described in the guidelines was first developed by a drafting group of the Codex ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology based on the recommendations of the 2001 FAO/WHO Expert Consultation on Evaluation of Allergenicity of Genetically Modified Foods. The intention for further testing of a protein derived from a known allergenic source that tested negative in in vitro immunoassays using sera from individuals allergic to that source and that lacked amino acid homology with known food allergens was to subject the protein to a more rigorous level of testing. The initial step of subjecting the protein to in vitro testing and proceeding with only those that produce a negative result reduces the possibility that test subjects, i.e., individuals with clinically confirmed allergies to the food source of the protein, will experience a negative reaction in a skin prick test. A positive result in in vitro immunoassays for a protein derived from a known allergenic source using sera of individuals allergic to that source would suggest that further development of the product might be undesirable unless strict segregation and identification of the resulting food product could be ensured. Since sera for in vitro immunoassays is obtained from "individuals with a clinically validated allergy to the source of the protein," a positive result would suggest that the protein was indeed allergenic, whereas a negative result would prompt further testing to confirm this conclusion as described above.

With respect to unintended effects on endogenous allergens, at the present time, information on threshold ranges for allergic response/sensitization is not well-characterized. The concern was whether an increase in the content of allergenic proteins in a particular crop would increase the number of people for which the sensitization threshold would be exceeded. If the standard-state allergen is unaffected by the modifications through either rDNA or non-rDNA techniques, the applicant would not be expected to fully characterize this allergen.

To address the request for clarification of the strategy used to assess the potential allergenicity of novel proteins, in section 4.1.3.7, of the revised guidelines the word "expected" has been inserted into the last paragraph of the assessment strategy section so that the sentence now reads "The expected absolute exposure to the newly expressed protein ...." As well, additional wording has been added to section 4.1.2.6, under the novel proteins heading to clarify the assessment of novel proteins.

Summary of comments received:

In general, all respondents think that a previously authorized novel food could be used as a suitable counterpart for comparison in the safety assessment of a proposed novel food, although some think that conditions should apply. One respondent suggested that a previously approved novel food could be used as a comparator for a new novel food if it had undergone more than a decade of surveillance without adverse effects. Another suggested that an approved novel food could be used as a comparator if it meets the criteria of the history of safe use definition (although they do not support using the 100-year time frame). Another respondent suggested that if the government did not treat an approved novel food as a suitable counterpart they would be "..implicitly questioning the reliability of its own safety assessment process."

In addition, a comment was received relative to text in the consultation document preceding this question - a respondent requested clarification on the reason for the requirement of raw data and to which studies this requirement refers to.

Food Directorate Response

The purpose of this question was to get feedback which will be used to refine Health Canada's position on this issue. As this issue is not explicitly addressed in the guidelines, no changes to the guidelines have been made as a result of the comments received.

With respect to the question regarding when raw data is required, it should be noted that this is not a new stipulation. It is a standard requirement and is a key element of the integrity of the review process.

Summary of comments received:

The majority of respondents felt that the guidelines are sufficiently clear in this regard. One respondent suggested that the assessment criteria for antibiotic resistance marker genes could be clarified by identifying these as a type of marker gene in Section 4.1.3.2 of the guidelines. It was also suggested that a quick explanation/reasoning behind the links between microbial compounds and antibiotic resistance could be included although the comment indicated that this was not a necessary change. Other comments received related to the use of antibiotic resistance marker genes in general.

Food Directorate Response

No changes were made to the guidelines as a result of feedback received on this question, as the majority of respondents thought that the clarity of the guidelines was sufficient in this regard. Antibiotic resistant genes are used as markers for identification purposes in the development of some novel food products. As stated in the guidelines, wherever possible, transformation markers which generate safety concerns should not be present in the final food product. The guidelines also indicated that the use of marker genes that confer resistance to clinically important antibiotics should be avoided. If selectable markers are present in the final food, they are evaluated for safety (potential allergenicity and toxicity of the gene product, potential impact on human health if a gene transfer could occur, etc.). Comments relating to the use of antibiotic resistance marker genes in general will be considered along with those received in response to consultation point #15 and will be used to refine Health Canada's policy on this issue.

Comments on Format, Content, Readability, and Consistency with International Guidance

Summary of comments received:

A number of respondents suggested that a comparative table of regulatory requirements between Canadian authorities and/or international bodies could be included. A few respondents found that the guidelines are repetitive and suggested that the document could be simplified by combining all safety assessment recommendations, however they stated that the current format is understandable and this change is not essential. Other comments received suggested closer alignment with OECD consensus documents regarding compositional analyses of novel foods, re-examination of the guidelines with respect to the 1998 US/Canada Bilateral Agreements on Agricultural Biotechnology, changing the novel food definition, and including a current list of approved novel foods. Finally, a respondent suggested that Health Canada perform focus group evaluations, especially with those groups most likely to purchase novel foods.

Food Directorate Response

With respect to the comment regarding the inclusion of a comparative table of regulatory requirements, the Food Directorate did not think that the guidelines are an appropriate place for such a table. Other options for addressing this comment will be explored.

While a couple of respondents felt that the format of the guidelines was too repetitive, they did not think that changing the format was essential. The Food Directorate had considered developing a more streamlined document, but decided that the current format, while repetitive, is more useful to petitioners who are not familiar with the information requirements for different types of novel foods.

With respect to the comment regarding closer alignment with the OECD consensus documents, it is important to note that Health Canada agrees with this suggestion. Consensus documents on compositional considerations for new varieties of various crops, developed by the OECD's Task Force for the Safety of Novel Foods and Feeds, are available and should be consulted for further guidance with respect to particular crops. These documents suggest which key nutrients, anti-nutrients and toxicants associated with the crop should be analysed and provide data on the typical composition of the crops and their main products. Since these consensus documents are guidelines, it is recommended that Health Canada be consulted with regard to which components should be included in an assessment.

Regarding the US/Canada bilateral on agricultural biotechnology, it should be stressed that Health Canada has not strayed from the intent of this document. The revised guidelines reflect relevant national and international developments in the safety assessment of novel foods that have occurred since the publication of the original guidelines in 1994. This includes the recently adopted Codex guidelines which were developed with participation of 165 member countries including Canada and the US.

With respect to the suggestion regarding the inclusion of a current list of approved novel foods in the guidelines, it should be noted that there is a list of approved novel foods on the Novel Foods web site ( http://www.novelfoods.gc.ca) which is regularly updated. To avoid the problem of outdated information, instead of including this list in the guidelines, a reference to the web site list has been included in the guidelines.

The implication of the comment from the public health organization is that these guidelines are intended to be read by consumers. In fact, they are intended to provide guidance to industry regarding novel food pre-market notifications to Health Canada. As part of the communications plan surrounding the publication of the revised guidelines, a fact sheet will be drafted to accompany the guidelines and explain their purpose for the general public.

Food Directorate Response to General Comments Not Included Above

Several general comments on the revised guidelines were received in response to Part I of the guidelines. As these comments do not directly relate to the points of consultation they will be summarized here.

A respondent indicated that the terms genetic engineering and genetic modification should be distinguished in the guidelines. Genetic modification is defined in Division 28 of the Food and Drug Regulations as a change in the heritable traits of an organism. While this definition is broad, various breeding techniques, such as mutation breeding and the use of rDNA techniques, can cause a food product to be substantially different from traditional products on the marketplace. As a result, Health Canada regulates all products of genetic modification and not only products produced using genetic engineering. It should be noted that this comment was raised in the context of the Canadian General Standards' Board's voluntary labelling standard which applies only to food products derived from rDNA technology. This standard is not related to health or safety issues, it is focussed on consumer interest in a certain class of food products.

A comment was received regarding the labelling of novel foods. As with all foods, including foods derived through genetic modification, Health Canada requires special labelling to address health and safety issues that can be mitigated through labelling such as identifying the presence of an allergen. Labelling is also required to identify compositional or nutritional changes. In these situations, labelling is required to alert consumers or susceptible groups in the population at large. For example, where the composition of a product has been intentionally modified, such as increasing the level of lauric acid in canola oil, a different common name will be required to describe the oil. Additional wording has been added to section 4 of the guidelines to improve the understanding of labelling requirements.

With respect to the use of assertive language throughout the guidelines, it is important to note that guidelines are not requirements and therefore care must be taken not to imply requirement where it is not appropriate. Nevertheless, the use of words such as "should", "shall", "must", "require", etc. throughout the document have been reviewed. It should be noted that the guidelines require flexibility due to the broad range of products that are being developed for the marketplace.

With respect to adverse reactions, including allergic type reactions to foods, it is the CFIA that tracks all reported consumer complaints and investigates them. Follow-up information gleaned by the agency in its investigation is normally shared with the Food Directorate, Bureau of Chemical Safety, for the purpose of a health risk assessment. In turn, the Agency will take appropriate compliance action given the risk and other factors (e.g. Class I recall). Shared information between Health Canada and the CFIA related to adverse reactions to foods includes product formulation, cross-contamination and mislabeling issues, analytical results, and the details of the adverse reaction / illness report.

Conclusion

Comments and feedback received during the public comment period have assisted the Food Directorate in the finalization of the revised guidelines. While there were a variety of suggestions submitted to improve the guidelines, most stakeholders provided a general endorsement of the guidelines. The Food Directorate guideline revision working group has evaluated the comments received in response to the public consultation and modified the guidelines where appropriate.

² Recent documents developed by the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology are the Draft Principles the Risk Analysis of Foods derived from Modern Biotechnology, the Draft Guidelines for the Conduct of Safety Assessment of Foods derived from Recombinant-DNA Plants and the Draft Guidelines for the Conduct of Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms (see reports of the Third and Fourth Sessions of the Task Force at: http://www.codexalimentarius.net/reports.asp).

Part II - Looking Forward

The second part of the consultation covered issues related to the general context under which novel foods are regulated in Canada. Stakeholders had the opportunity to comment and bring to the attention of the Food Directorate potential benefits, risks, and implications associated with specific issues and initiatives currently being examined by the Directorate, such as the coordination of regulatory decisions between Health Canada and the CFIA, proposals to increase transparency and create more opportunities for providing input into decisions related to novel foods, as well as technical issues such as the use of antibiotic resistance marker genes.

The Food Directorate would like to thank the stakeholders who provided input for these points of consultation. One hundred and four comments were submitted for this part of the consultation from government organizations, industry and public health groups. The following is a summary of these comments and the response of the Food Directorate, where suggestions and concerns expressed are addressed.

2.1 Coordination of regulatory decisions made by Health Canada and the Canadian Food Inspection Agency

Point(s) of Consultation:

The policy regarding the coordination of regulatory decisions is now articulated in the revised guidelines as well as in relevant regulatory directives of the CFIA. This initiative has primarily involved Health Canada and the CFIA since all novel foods derived from genetic modification reviewed so far are from plant origin. Consistent with the recommendations made by the Canadian Biotechnology Advisory Committee³, the Food Directorate is anticipating broadening this policy to cover products derived from animal and microbial sources which, in addition to requiring pre-market notification under the Novel Foods Regulation, also require notification to Environment Canada pursuant to the New Substances Notification Regulations under the Canadian Environmental Protection Act (CEPA).

Summary of comments

The comments regarded mainly the collaboration between Health Canada and the Canadian Food Inspection Agency. The participating stakeholders wished there was better communication between the two entities both during the assessment process and using a harmonized vocabulary. Regarding the consultation sessions, it was suggested that there should be a delay between consultations held by Health Canada and those held by the Agency, so that stakeholders may better distinguish between the two consultation processes. Certain stakeholders also suggested that conditional authorizations be granted by Health Canada while the Agency completes its environmental assessment of a product. Finally, it was suggested that a registry of producers and importers of novel foods be established and that inscription to this registry be made mandatory.

Regarding the collaboration between Health Canada and Environment Canada, no suggestions were put forward by stakeholders. However, other suggestions indirectly related to the assessment of novel foods have been put forward. These have been retained for future consideration.

Food Directorate Response

Health Canada, through its Health Protection Legislative Renewal project (http://renewal.hc-sc.gc.ca) and the governmental response to the recommendations of Royal Society of Canada and of the Canadian Biotechnology Advisory Committee, is considering some of these issues (harmonization of the vocabulary, information during the assessment process). Therefore the comments on these issues submitted by stakeholders will be brought to the attention of the appropriate groups. Furthermore, Health Canada shall take into consideration other consultation activities in progress during the implementation of its own consultation sessions. In regard to conditional authorizations, Health Canada and the Canadian Food Inspection Agency have established a "no split approval" policy which does not allow for authorizations prior to the completion of the food, feed and environmental safety assessment of a plant with novel traits. Before any product derived from biotechnology can be commercialized, it must have been approved by each affected department or agency, to avoid the introduction of unauthorized products to the Canadian market.

2.2 Transparency and public/expert involvement

Point(s) of Consultation:

To increase transparency and participation of the public and external experts in decision-making in the areas of novel foods, we are considering the following two pilot projects and seek your comments and recommendations.

A. Proposal regarding transparency and public involvement (Pilot Project A)

The Food Directorate is interested in initiating a pilot project (pilot project A) in which scientific evaluators of the Directorate and those of the Food Standards Australia New Zealand⁴ (FSANZ) would work together on a review of a submission for a genetically modified food using the submission review procedure followed by FSANZ (See description in consultation document). The objective of this pilot project is to assist the Department in determining how to refine the review process in place for novel foods in Canada.

Discussions have been initiated with FSANZ. We are currently looking for proponent(s) who would volunteer to participate to this project.

B. Proposal regarding external expert participation in Food Rulings Committee (Pilot Project B)

As described in section 1.3 of the consultation document, the Food Rulings Committee⁵ is the decision-making forum for all risk management decisions related to foods, including novel foods. This committee is comprised of Food Directorate officials and representatives from the CFIA and from other directorates and offices of Health Canada. Consistent with the commitment made in the Action Plan published in response to the recommendations of the Royal Society of Canada's Expert Panel, the Food Directorate is developing an approach for external expert(s) to participate in the Food Rulings Committee's deliberations.

We will first conduct a pilot project focussing on external expert participation in the Committee's deliberations on novel foods. In the long term, we hope to extend this practice to all products regulated by the Directorate so that our decisions benefit from the scientific perspective of additional experts from academia and other non-governmental organizations.

Point # 9
Summary of comments and Food Directorate Response

Three organisations/industry participants submitted their information to take part in Pilot project A. Unfortunately, none of them had the desired profile (that is, novel food developers who would require a notice of submission). Two other participants also offered to participate in the project. We took note of their offer and will contact them if necessary.

Point # 10 and 11
Summary of comments
Pilot Project A

While two participants from industry desire public transparency, they are in total disagreement with the pilot project. They believe that it is important that the public be involved in the policy-making process but that they should not be directly implicated in the evaluation, which should be done by experts only. One participant is also concerned that the Canadian agricultural reality might be misrepresented in the foreign process. Finally, the advantage of involving the public in the evaluation process is questioned. Participants from health sector and government are in favour of the project arguing that it will allow a better comprehension of public involvement and will improve the efficacy of the evaluation process. However, it is suggested that more than one submission be reviewed to make this pilot project truly worthwhile.

On the point to increase transparency, many suggested making the information available to the public by publishing decision documents or case studies for example. The information can also be shared through means of mandatory labelling, education and access to nutritional composition databases. As far as participation is concerned, only one suggestion was made encouraging projects allowing for public comment on notices of submission.

Pilot Project B

The majority of respondents supported the proposal of having external experts participate in Food Rulings Committee meetings and considered it worthy of further investigation. Some industry respondents questioned the appropriateness of this project in achieving the objectives of increasing transparency and public involvement. They expressed the opinion that external experts should be consulted on an ad-hoc basis to address specific issues that were outside the expertise of government or posed a challenge to government evaluators.

Role of External Expert

Comments on the responsibilities of the external participant varied considerably. Comments could be categorized to indicate support for one of two possible roles for the external expert: either an "oversight" or "advisory" role. The "oversight" type role of the expert would include review of documents, evaluation tools and methods, evaluation of the assessments scientific rigour and participate in the decision-making process on a routine basis. Other respondents were supportive of a role categorized as "advisory". They indicated that experts should act as technical advisors to be consulted on topics or issues referred to them. While they would add value to the decision-making process they would have no decision-making power. Respondents indicated that the external expert should be expected to be informed on current issues and participate effectively and duly provide advice. Finally, some respondents thought the external experts should be responsible for undertaking consultations with stakeholders on issues while others thought they need simply abide by the Food Rulings Committee Terms of Reference and contribute meaningful information to the process.

Selection Criteria

A variety of criteria for selecting and screening potential experts to participate in Food Rulings Committee meetings were proposed by respondents. Many respondents expressed the opinion that the experts should have scientific expertise and experience in fields such as risk assessments, food systems, specific food issues and techniques used in biotechnology. Others were of the opinion that the experts should have expertise and experience in diverse fields including ethics, population and public health and anthropology. Other recommended selection criteria included the consideration of scientific credentials, publication lists, and demonstration of a lack of conflict of interest. One respondent thought government, industry and civil society should be involved in the selection process.

Advantages and Challenges of Participation of External Expert

The respondents identified several disadvantages or challenges associated with this project and only a few advantages. Broadening the expertise at the Food Rulings Committee table, increasing the openness of the decision-making process and improving the public confidence in the process were viewed as the advantages of having an external expert participate at Food Rulings Committee meetings. A disadvantage of the project was the intent to have only one external expert participate at Food Rulings meetings. It was indicated in the comments that one person could not be expected to provide the necessary expertise in all areas addressed during the review process and provide the appropriate perspective. Furthermore, respondents were concerned that with a single expert personal biases could not be balanced. Respondents expressed concern that the pool of experts available in Canada is small and that participants would be required to commit a significant amount of time to the project. It was also indicated that the cost of the project and the time that would be added to the novel food approval process were disadvantages. The difficulties in thoroughly addressing conflict of interest security and confidentiality issues, particularly in emerging fields, were also raised. In discussing disadvantages, one respondent noted that the public may not perceive the experts as "non-governmental" if they are being paid.

Food Directorate Response

Participants may have misunderstood certain components of Pilot Project A. The purpose is not to apply Australia or New-Zealand agricultural evaluation criteria to Canadian products, but rather to test their decision-making process during our evaluations. The Food Directorate believes that the considerations for public involvement included in the Australia-New-Zealand evaluation process offers clear advantages. We will therefore continue to explore different possibilities for this pilot project.

Health Canada made a commitment to initiate pilot project B in the Action Plan of the Government of Canada released in November 2001, in response to the Royal Society of Canada's Expert Panel Report titled "Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada". In designing the pilot project, the Food Directorate is giving careful consideration to the recommendations and concerns expressed by respondents. To ensure that issues of conflict of interest, confidentiality and security are appropriately addressed, a mechanism to screen experts will be adopted. Consideration is being given to minimize the impact of the pilot on the safety assessment process and keep the role and expectations of the external expert in line with those of other Food Rulings Committee members.

Point #12
Summary of comments

The responses received for this point of consultation were quite diverse and touched on different facets of the issue.

It was suggested that proponents could be asked to prepare a version of their submission in a "Press Release" format, to be edited and posted by Health Canada. These documents, while informing the public about the development and safety of a novel product, would not compromise the proponents confidential business information.

It was also suggested that Health Canada conduct a pilot project in which voluntary disclosure of information about a specific product would be provided to a sample population. (e.g., consumers) The purpose of this project would be to assess the population's reaction in terms of interest, thrust, and other pertinent variables. The resulting information could then be used to weigh the resulting advantages and drawbacks to the proponent's competitive position.

As a complement to the posting of novel foods decisions, it was suggested that case studies of safety assessment as well as examples of decisions for food products not considered novel could be posted on Health Canada website.

Some respondents commented on the need to define more clearly what can be considered confidential business information (CBI). It was proposed that a policy should be adopted that recognizes that scientific data relating to the safety of foods derived from GM organisms do not automatically fall within the confines of CBI. The establishment of criteria and the use of a decision-tree were suggested as means to assist in distinguishing proprietary information from what is in the public domain.

The suggestion was also made that the Food Directorate should examine what is done in other regulatory systems, nationally and internationally in terms of voluntary disclosure of information and transparency.

Finally, with respect to who determines what is considered CBI, one respondent suggested that applicants should have an opportunity to identify which part of the information provided they deem confidential while another respondent noted that regulators should have more control over what can be claimed to be confidential.

Food Directorate Response

Few comments addressed directly the request of providing suggestions to maximize the voluntary disclosure of information. However, what has been submitted will be taken into consideration when developing or refining policies and will help the Food Directorate to increase transparency.

As part of the Government of Canada commitment to increase transparency in the regulation of biotechnology-derived products, Health Canada and CFIA have initiated a pilot project in co-operation with CropLife Canada, an industry association representing developers of biotechnology-derived plants. This project consists of posting "notices" on the Health Canada and CFIA web sites after receipt of new submissions. These notices describe the product and summarize the scientific information provided for regulatory review to Health Canada and the CFIA. The public has 60 days to provide input on scientific matters relevant to the evaluation of each of these new product submissions. Further information on this project, including notices of submission, can be found at: ( http://www.novelfoods.gc.ca) under the heading "Pilot Project".

Health Canada is proposing measures under the proposed Canada Health Protection Act (CHPA) to make the review process more open to the public while guaranteeing a reasonable degree of protection for confidential personal and commercial information. These measures include the status of pending submissions for market approval and summary of data presented by the manufacturer to demonstrate the safety of a new product. This aspect of the detailed proposal on CHPA is discussed in section B8.6 of the document titled Health Protection Legislative Renewal - Detailed Legislative Proposal available at http://renewal.hc-sc.gc.ca

In the short term, the Food Directorate remains committed to find ways for proponents to voluntary disclose more information about individual product submissions.

2.3 New information

Point(s) of Consultation:

While the sale of a food that poses a hazard to the health of the consumer is prohibited, contravenes relevant provisions under the Food and Drugs Act and constitutes a criminal offence, there is currently no legal requirement to notify Health Canada when a person becomes aware of new information regarding the risk to human health that could result from the consumption of a novel food once it has been allowed entry onto the marketplace. In contrast, such practice is explicitly required for products of biotechnology regulated by the CFIA under the Seeds Act and the Feeds Act.

The Food Directorate is considering addressing this issue by making explicit in legislation that such new information be required to be submitted to Health Canada. This would be done under the Health Protection Legislative Renewal Initiative. (see section 2.2 of the consultation document for more information regarding this initiative)

Summary of comments

The majority of respondents supported the proposed approach. One common theme amongst comments received was the importance of having consistent approaches across regulatory departments. In particular, reference was made to the current requirements under the Seeds and Feeds Acts administered by CFIA and Section 70 of Canadian Environmental Protection Act, 1999.

The need to clearly define who (e.g., manufacturers, researchers) would be required to notify Health Canada, what type of information would trigger such a post-market notification and the necessity for each entity to be aware of their responsibilities was emphasized.

One respondent expressed the opinion that Health Canada already has the legislative authority through the Food and Drugs Act to deal with the sale of food that poses a hazard and that further legislation to require the submission of new information is not needed.

It was pointed out that products derived from genetic engineering should not be selected out from other products for mandatory reporting of adverse effect.

It was also suggested that this question be subject to further consultation with governments, researchers, academia and industry.

Additional issues brought forward by respondents in response to this point of consultation included the need for periodic review of approved novel foods. Note: The aspect of the integrity of novel foods is being addressed in point #14 of the consultation.

Food Directorate Response

Under the proposed CHPA, the Food Directorate is examining issues related to the requirement to report adverse health effects and information that could have health and safety implications at the post-market stage. Suggestions made by the respondents will be considered in developing the policy supporting the proposed legislative framework. The requirement for submission of new information or reporting of adverse health effects would be applicable to all foods that are subject to pre-market or pre-clearance review, including novel foods which comprise but are not limited to foods obtained through genetic engineering.

2.4 Integrity of novel foods

Point(s) of Consultation:

Our proposal is to require the submission, by proponents, of molecular and biochemical characterization data over a specified number of years after such novel foods have been on the Canadian market. This would give the Department the opportunity to verify the ongoing integrity of these products leading to increased consumer confidence. Such a requirement would necessitate amendments to the regulations and would, in effect, impose time-limited approvals.

Summary of comments

While a few respondents strongly supported time limited approvals, other respondents were divided in two main groups, one not in favour of the proposal and the other presenting their views in a balanced manner by listing the inherent advantages and disadvantages without clearly indicating either support or disapproval.

a) Benefits and Disadvantages

Health Canada's position in the consultation document is that the department's ability to verify the ongoing integrity of novel foods via time limited approvals would lead to increased consumer confidence. Some respondents expressed their disagreement with this statement and indicated that the concept of an integrity review would reduce public confidence in the original review, and bring into question the regulatory system in the long term.

It was generally acknowledged that a requirement for time-limited approvals would increase the regulatory burden, resource pressure and delay in the process. It was also pointed out that this would be inconsistent with the SMART regulation initiative.

It was mentioned that by adopting the approach as stated in point #13, Health Canada would have the ability to review new product information and to change the approval status of a novel food at any time based on this information.

One respondent questioned the jurisdiction of the Food and Drugs Act to regulate at the level of the integrity of the transformation event. The need to ensure long term integrity in terms of quality control and efficacy as they relate to their commercial interests was pointed out, and the respondent did not see the issue as a health and safety concern.

Responses received regarding a possible time interval for requiring data to be submitted pointed out that product's characteristics such as complexity, life cycle, potential for allergic response, toxicity, and level of consumer exposure should be considered. Some respondents indicated that five years was an acceptable time frame to submit characteristic data, while others indicated that ten years was appropriate for a major review, but that monitoring and data submission obligations should be imposed on a continuous basis before that review takes place. It was suggested Health Canada look at what is done in the European Union under Directive 2001/18/EC and by the United States Environmental Protection Agency.

b) Other mechanisms for ensuring post market integrity

Suggestions received regarding other mechanisms explored similar themes, i.e., continuous monitoring, reporting and auditing. With regard to these mechanisms, the developer would be required to gather molecular and biochemical data on an ongoing basis and make it available for audit on request. This would necessitate that Health Canada establish post-approval monitoring procedures. The advantage of such an approach would be a decrease in the regulatory burden as the amount and variety of novel foods increase.

Other alternatives included mandatory labelling, regular inspections according to good manufacturing practices (GMP), and conditional authorizations such as those mandated by CFIA's feed section under directive DIR-95-03.

c) Other comments

Some respondents questioned the benefit to the safety of novel foods that time-limited approvals would have, the scientific basis for time-limited approvals and Health Canada's true interests in the area of long term surveillance.

It was suggested that Health Canada should not use time-limited approvals as a substitute for post-market surveillance but instead undertake a Canadian consumption survey to provide baseline information for risk modelling. This may involve the need to establish indicators such as food consumption patterns, chemical changes in GM foods, population-based patterns for allergies and other reactions to foods.

Food Directorate Response

The issue of ensuring the integrity of novel foods is one of health and safety and falls under the jurisdiction of the Food and Drugs Act. The long term integrity of the transformation event is important in ensuring that the attributes of the products as reviewed are the same as those of the products on the market. In addition, the commercial interests of developers in maintaining the efficacy and quality control of novel foods are evident and are in alignment with the interests of regulators.

Health Canada is continually examining its review process for biotechnology derived products. Comments received on the proposed mechanism for re-evaluating approved products are being considered in our regulatory review in support of this initiative. The Food Directorate will make all effort to not increase the regulatory burden and to avoid delay in the process.

2.5 Antibiotic resistance marker genes

Point(s) of Consultation:

While the antibiotic resistance marker genes present in genetically modified foods that have been allowed onto the market to date do not pose a health or safety concern to the consumer, Health Canada has been encouraging the use of alternative approaches that do not result in the presence of antibiotic resistance genes in foods for the development of future products to address the concerns expressed by the public regarding antibiotic marker genes. The Department is considering banning the use of antibiotic resistance marker genes in future novel foods when alternative strategies become available.

Summary of comments

Comments made in point #6 of the consultation relating to the use of antibiotic resistance marker genes are also considered here. There was no common trend seen in the comments received. Some respondents indicated that such a ban would have a negative impact on developers, hindering innovation and increasing the length and cost of the development process. Consumers would likely support banning of antibiotic resistance markers in products destined for food but some respondents raised the possibility that previously approved novel foods containing antibiotic resistance markers may be perceived as no longer safe by the public.

Some respondents agreed with and encouraged the need to develop alternatives to avoid use of antibiotic resistance markers. However, a concern was raised that these new technologies could present unknown health risks as they may not have a history of safe use and as such, scientific data supporting their safety may be limited.

A number of respondents indicated that the Food Directorate should not ban the use of antibiotic resistance marker genes without scientific justification and should base their regulatory decisions on science. Safety assessment done for selectable markers would identify any potential safety concerns as it would for any other introduced gene and newly expressed gene product.

Food Directorate Response

Antibiotic resistance genes are used as markers for identification purposes in the development of some novel food products. The use of marker genes that confer resistance to clinically important antibiotics should be avoided. If selectable markers are present in the final food, they will be evaluated for safety (potential allergenicity and toxicity of the gene product, potential impact on human health if a gene transfer could occur, etc.). No changes have been made to the guidelines regarding the use of these markers.

³ Health Canada and other relevant departments and agencies are preparing a detailed response to the Canadian Biotechnology Advisory Committee's report entitled "Improving the Regulation of Genetically Modified Foods and other Novel Foods in Canada" published in August 2002 (http://www.cbac-cccb.gc.ca).
⁴ The regulatory agency responsible for food regulation in Australia and New Zealand. More information can be found at: http://www.foodstandards.gov.au
⁵ The Food Rulings Committee is a management committee of senior officials representing all bureaus in the Food Directorate. Representatives from several organizations within Health Canada and the CFIA are invited to participate in discussions of the committee. The committee oversees and directs the development of regulatory and policy proposals related to food safety and nutritional quality by the Food Directorate bureaus or science and policy teams. The committee considers these proposals and plays a key role in the policy development process by making policy, regulatory and other risk management recommendations to ensure the safety and nutritional quality of foods offered in the Canadian marketplace.

PART III - Foods Derived From Cloned Animals

The third part of the consultation document solicited opinion on the topic of foods derived from cloned animals produced using somatic cell nuclear transfer (SCNT) technology. This was done as a preamble to future consultations on the assessment criteria for novel foods derived from animals which will feed into the drafting of the relevant section of the "Guidelines for the Safety Assessment of Novel Foods".

The Food Directorate would like to thank the stakeholders who responded to this part of consultation. These include academia, industry, government organizations, and non-governmental organizations. The following is a summary of the comments received and the response of the Food Directorate.

Point(s) of Consultation:

The Food Directorate, as part of an interdepartmental working group on animal biotechnology, is in the process of identifying issues related to cloned animals obtained through somatic cell nuclear transfer. This includes potential human health risks associated with the consumption of cloned animals and products derived from them or their offspring.

As an interim policy, Health Canada considers foods produced from livestock developed using the technique of somatic cell nuclear transfer to be captured under the definition of "novel food" and therefore subject to the Novel Foods Regulation. Developers producing cloned animals through SCNT must therefore not release any cloned animals, their progeny, or their products/byproducts (including meat, eggs and milk) into the human food supply unless they have been subjected to the pre-market safety assessment required of novel foods. Since, at this time, there is insufficient data to guide the safety assessment of these products, developers who wish to use this technology for producing food livestock are being requested to withhold novel food notifications until requirements are determined and further guidance is available. This interim policy is posted on-line at: http://www.novelfoods.gc.ca

Summary of comments

Comments provided for this point of consultation were polarized and, for the sake of this summary, were grouped as follows: 1) cloned animals, their progeny, and foods derived from them need little if any additional regulation, and 2) cloned animals, their progeny, and foods derived from them need regulatory oversight.

1. The first group of stakeholders argues that it is the progeny of the SCNT cloned livestock which are most likely to enter the food chain, not the clones themselves. The progeny of these clones are produced via traditional livestock breeding and therefore will be no different than other animals produced by similar methods. From this it follows that foods derived from these animals should not pose any concern, as they do not differ from the food derived from other animals also produced via conventional means. The rationale being, that because the progeny are produced via sexual reproduction, any errors that could have been caused by the cloning process would be erased during, a) the formation of germ cells in the cloned animals, and b) fertilization of the egg cells. This groups feels that clones and their progeny, and products derived from them, should not be regulated any differently than any other animals or animal derived products.
   
   In the view of this group of respondents, Health Canada should lay down as soon as possible a well-articulated policy with well-defined time frames and guidance. Appropriate resources should be given to Health Canada to complete this task within the allotted time period. Lack of a time frame leaves the developer in a position where they cannot plan any future actions. It is also suggested that a lack of promptness may also handicap the livestock breeding industry on the international scene.
   
   Some of the respondents provided preliminary data on the health status of animals produced using SCNT which will be considered in our risk assessment and policy development on this issue.
   
   
2. The second group believes that the safety of the SCNT technology must be demonstrated from a food safety and animal health and welfare perspective. This concern is based on some previously observed abnormalities in cloned animals. The need for a system for tracking or monitoring of cloned animals was raised, as the use of SCNT technology might create international trade issues. This group also believes that consumers will accept the decision of Health Canada on the safety of foods derived from SCNT cloned animals as long as they are confident that the situation is being monitored and that if a problem occurs in the future all SCNT cloned animals can be accounted for. The need for labelling of foods derived from cloned animals was also raised, to permit consumers to make an informed choice.

Food Directorate Response

Comments related to foods derived from cloned animals received during this consultation will be considered during the development of materials for a future consultation on animal biotechnology. The new consultation, which is being planned for 2005, will seek input from experts and the public on the draft version of the section covering novel foods derived from animals. This will build on the consultation on the Revision of Health Canada's Guidelines for the Safety Assessment of Novel Foods which covered novel foods derived from plant and microbial sources.

The safety criteria which are being drafted reflect new scientific and regulatory developments in the field of animal biotechnology. We are also taking into consideration outcomes of previous technical workshops on animal biotechnology held in Ottawa in1998 and 2001 and outcomes of expert groups such as the "FAO/WHO Joint Expert Consultation on the Safety Assessment of Foods Derived from Genetically Modified Animals including Fish" (held in November 2003) and the "Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology"

Health Canada along with other departments (CFIA, EC, AAFC, and DFO), has just completed an issue identification document, which is the first step of Health Canada Decision-Making Framework (http://www.hc-sc.gc.ca/hpfb-dgpsa/hcrisk_cp_e.html). This issue identification paper discusses the question of animal heath and welfare, the unknowns related to food safety, human health in general, environmental impacts and some of the ethical/moral issues raised by this technology.

Many of the points raised by respondents have also been raised in the issue identification document and reinforces their importance. The data provided by some of the respondents will be useful in further assisting us in our risk assessment and policy development on this issue.

The issue identification document will become available to our stakeholders once it receives final approval. This will give further opportunity for our stakeholders, including promoters of this technology, to provide information which will help fill in the information gaps identified in the issue identification document. Filling in these information gaps will aid Health Canada in reaching a final policy decision concerning the foods derived from cloned animals and their progeny.

Once enough information is obtained and analysed, a risk/benefit analysis will be performed as per Health Canada's decision-making framework. Regulatory options will then be presented and discussed with stakeholders as part of a consultative process. Issues brought forward in the present consultation will also be considered as part of these options.

Health Canada has published, in September 2003, an interim policy whereby foods produced from livestock developed using SCNT are considered novel foods and require notification to Health Canada. At this time, petitioners are requested to withhold notifications until requirements are determined and guidance is available. The interim policy can be found on the website of the Novel Foods Section at http://www.novelfoods.gc.ca.