Canada regulates products derived from biotechnology processes as part of its existing regulatory framework for “novel products.” The focus is on the traits expressed in the products and not on the method used to introduce those traits. The Canadian Food Inspection Agency (CFIA) is responsible for regulating genetically modified (GM) plants and approving GM feed for animals. Health Canada is mandated to assess the safety of foods for human consumption, including genetically modified organisms (GMOs) in foodstuff, and for authorizing them to be sold in Canada. Advertising or labeling the presence of GMOs in particular food is voluntary unless there is a health or safety concern.
- The use of non-human reproductive material in humans
- The use in humans of human reproductive material previously transplanted into a non-human life form
- The creation of chimeras made from human embryos
- The creation for reproductive purposes of human/non-human hybrids
In China, restrictions on genetically modified organisms (GMOs) are primarily provided by the agricultural GMO regulations enacted by the State Council in 2001 and relevant administrative rules. The agricultural GMO regulations regulate not only crops, but also animals, microorganisms, and products derived from these sources.
The testing, production, and marketing of GMOs in China are subject to government approval. Foreign companies that export GMOs to the PRC, including GMOs as raw materials, must apply to the Ministry of Agriculture and obtain GMO Safety Certificates.
Japan enacted the Cartagena Act in 2003 to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The Act classifies genetically modified organisms (GMOs) according to two types of uses: use with containment measures and use in open space. Both uses are regulated by the Act, but the latter use is the more regulated of the two.
Although it is legal to plant genetically modified (GM) crops in Japan if certain procedures are followed, no commercial planting of GM crops (aside from ornamental flowers) is occurring in Japan at this time, mainly because the general public is skeptical about the safety of GM crops. Nevertheless, Japan is one of largest importers of GMO foods, though labeling is required if GM crops are used in food in certain cases.
The Japanese law currently limits research on human–animal chimeric embryos by not allowing the development of such embryos beyond the appearance of the primitive streak (maximum 14 days post fertilization) and their transfer into an animal uterus. Recently, the Japanese Expert Panel on Bioethics supported the idea of creating a human––animal chimera and proposed that the Japanese research regulation “should be capable of responding flexibly to the advances in research”.
Regulation of genetically modified organisms (GMOs) is varied. All GMO products are evaluated by the European Food Safety Authority (EFSA).
The Human Fertilization and Embryology Act 1990, as amended by the Human Fertilization and Embryology Act 2008, applies to embryos that are either entirely or predominantly human or equally human and animal. It does not forbid the creation of animal chimeras by grafting human embryonic cells or embryonic cell lines into animals. However, transferring a human admixed embryo, which would be predominantly human, into an animal foster “mother” is forbidden. Of note, the definition of “predominantly human” is a crucial point, although admittedly difficult to resolve.
The German law forbids combining a human embryo with animal cells, but not the introduction of human cells into an animal embryo. The German Ethics Council (Deutscher Ethikrat) published an opinion paper in September 2011 on the use of human–animal mixtures in research. This paper highlighted the importance of finding a balance between expected medical benefits, respect of the animal welfare, and, overall, the need for an interdisciplinary scientific discussion on this subject.
French law stipulates that creating a chimeric human embryo is forbidden. The law clearly forbids the introduction of allogeneic or xenogeneic cells into a human embryo; however, it is unclear whether it also bans the introduction of human cells into animal embryos. We discussed this uncertainty elsewhere.
The FDA, EPA, and USDA currently regulate biotechnology products in accordance with the Coordinated Framework for Regulation of Biotechnology.
Plant, seeds, and other regulated article GMOs are regulated by the US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service under the Plant Protection Act.
GMOs in food, food additives, drugs, and biological products are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
GMO pesticides, plant incorporated protectants, and microorganisms are regulated by the Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act.
The form of regulation varies depending on the type of GMO involved.
Federal US laws do not rule this issue. Nonetheless, in 2005, “the U.S. National Research Council and the Institute of Medicine recommended limits on such research, among them that no human stem cells be added to primate embryos and that animal-human chimeras not be allowed to breed”.
The National Academies of Sciences has suggested the outright prohibition of only two types of chimeras: those in which embryonic stem cells of any origin are introduced into human blastocysts, and those created by the introduction of human pluripotent stem cells in non-human primate blastocysts.