ARCHIVED - Comments on the United States Food and Drugs Administration's Center for Veterinary Medicine's Animal Cloning: a Draft Risk Assessment

May 3, 2007

Division of Dockets Management
United States Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, Maryland 20852

Dear Sir:

Docket No. 2003N-0573

On behalf of the Government of Canada, the Canadian Food Inspection Agency and Health Canada would like to take this opportunity to thank the United States Food and Drug Administration's Center for Veterinary Medicine (US FDA CVM) for the opportunity to comment on the document: Animal Cloning: A Draft Risk Assessment. We have undertaken a technical review of the text and offer the following comments. This does not constitute a Government of Canada position on animal cloning.

General Observations:

The Government of Canada is committed to continue monitoring new scientific information with respect to animal cloning. We note that since the drafting of this document, many more publications have appeared in scientific journals and discussions continue at the international level (e.g. World Organization for Animal Health and International Embryo Transfer Society), complementing the information that is included in this document.

We appreciate that the FDA has kept the scope of the Draft Risk Assessment science-based and focussed on aspects related to food safety, nutritional composition, and health issues of animal clones and their progeny as is appropriate to risk assessment. However, the application of animal cloning in the agricultural sector is controversial and ethical debates surrounding this technology have taken place in Canada, the US, and in international fora. The Government of Canada, therefore, acknowledges that there are issues, such as environmental, indirect human health, ethical, animal welfare and socio-economical considerations, which will also need to be taken into account in the overall Canadian decision-making process regarding animal clones. Therefore, this response is limited to consideration of scientific issues related to food and feed safety and animal health.

In Canada, animal clones, their progeny and derived products are subject to the same rigorous health and safety regulations that apply to conventional animals and their derived products under the Health of Animals Act and Regulations, the Food and Drugs Act and Regulations, the Meat Inspection Act and Regulations, and the Feeds Act and Regulations, administered by the Canadian Food Inspection Agency (CFIA) and Health Canada. In addition, animal clones are considered as "novel" or "new", triggering additional regulations administered by a number of organizations: Health Canada for food safety and indirect human health effects; CFIA for feed safety, animal health and welfare, and enforcement of food standards and regulations; and, Environment Canada for environmental release.

In July 2003, as an interim policy, Health Canada stated that foods produced from livestock developed using SCNT cloning and from the progeny of such livestock will be considered to fall under the definition of "novel food." Novel foods are subject to the regulations in Division 28, Part B, of the Food and Drug Regulations. Developers producing animal clones through SCNT must, therefore, not introduce the products or by-products of any animal clones or their progeny to the human food supply in Canada, unless they have been subject to the pre-market safety assessment required for novel foods. However, as there is currently insufficient data to guide the pre-market safety assessment of these products, developers who wish to use SCNT technology for producing livestock, are requested to withhold novel food notifications until requirements are determined and guidance is available. This interim policy is posted on the Health Canada's website.

The Feed Section of the CFIA also considers products and by-products derived from SCNT animal clones and their progeny to be "novel feeds"; therefore, notification and assessment is required before any derived products from these animals are released in the feed chain. This assessment considers the safety of the feed to livestock, to humans via worker/bystander exposure and consumption of animal products, and to the environment. More information regarding the use of products and by-products derived from SCNT-animal clones into feeds can be found at the Canadian Food Inspection Agency's web site.

SCNT animal clones, their progeny and their products and by-products are also considered "new substances" under the Canadian Environmental Protection Act, 1999 and, therefore, require notification under the New Substances Notification Regulations. Prior to import or manufacture in Canada, manufacturers and importers of such substances are required to supply to the Minister of the Environment the information prescribed in these regulations that will allow this Minister and the Minister of Health to perform a risk assessment to determine if the new substance poses a risk to the health of Canadians and to their environment. More information regarding the requirements for notification of new substances is posted on Environment Canada's website.

The Government of Canada will, therefore, continue its current approach of assessing animal clones on a case-by-case basis and will use this Draft Risk Assessment, as well as other new information, in our continuing study of animal cloning with respect to food and feed safety and animal health considerations.

Technical Considerations:

To identify food consumption risks associated with SCNT, US FDA CVM has developed a two-pronged approach, which included a Critical Biological Systems Approach (CBSA) and compositional analysis. The CBSA evaluates animal health data. The compositional analysis follows and applies the comparative approach between food products from healthy animal clones and their progeny and corresponding products from conventional animals.

The US FDA CVM has suggested that the health of an animal can be an important indicator of food and feed safety (i.e., healthy animals produce healthy food and feeds). For example, animals with gross anomalies would not enter the human food supply. The Government of Canada recognizes the value of this general assumption, but also notes, as the US FDA CVM stated, that successful animal clones may appear healthy, but it does not preclude the risk of subtle hazards or unintended changes.

As stated, the US FDA CVM's Draft Risk Assessment only applies to a limited number of species (i.e. cattle, swine, goats) and any conclusions from this document should not be extrapolated to other species. While the Draft Risk Assessment considers many of the food/feed safety and animal health issues associated with cloning of these species, there are several areas in which the Draft Risk Assessment could benefit from more information, including, but not limited to:

  • A definition of "normal" and addressing the question of whether clones are normal. Furthermore, there exists no formal baseline data on milk and meat from various livestock, similar to what is being generated for major crops, which could be used as a robust comparator.
  • A baseline comparator for the outcomes of SCNT cloning as the information related to the animal health, food safety and composition of animals resulting from embryo splitting and blastomere transfer is not readily available in the published peer-reviewed literature and provide limited information as evidence of a history of safe use and as a baseline comparator.
  • A study regarding longevity of livestock clones, from both an animal health and a food/feed safety standpoint. In addition, there is limited information from multi-generational studies.
  • While some SCNT animal clones appear healthy and reach reproductive maturity, there is limited data on effects that may be more subtle and less easily detected, for example:
    • aberrant expression of imprinted-genes
    • effect of in vitro culturing conditions on cloned embryos
    • alteration of cell cycle and mitotic spindle apparatus leading to chromosomal aberrations
    • altered epigenetic control of gene expression
    • aberrant expression of endogenous retroviruses
  • More information on the potential toxicity, allergenicity and microbiological impacts should be presented, if available.
  • Regarding feed safety issues, more information on rendering and other modes of disposal via the feed chain is required, if available.


The Government of Canada will use this Draft Risk Assessment, as well as other new information, in our continuing study of animal cloning with respect to food and feed safety and animal health considerations. The current Government of Canada approach to oversight of animal cloning as described above, will continue to be applied on a case-by-case basis. We thank you for the opportunity to review the draft risk assessment, and look forward to continued collaboration between our organizations on this issue.

Yours truly,

Paul Mayers
Executive Director
Animal Products Directorate
Canadian Food Inspection Agency
Janet Beauvais
Director General
Food Directorate
Health Canada

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