Table 2 Regulation of animal cloning, transgenesis and gene editing in livestock in the main countries exporting beef to the European Union (EU)
Country | Animal cloning | Transgenic livestock | Gene edited livestock | ||
|---|---|---|---|---|---|
EU member states | Prohibited, until specific regulations on animal cloning are in place | Requires approval according to EU Directive 2001/18/EC and Regulation (EC) No. 1829/2003, safety assessment performed by EFSA GMO Panel | Requires approval according to EU Directive 2001/18/EC and Regulation (EC) No. 1829/2003, safety assessment performed by EFSA GMO Panel | ||
USA | Allowed, a risk management plan and guidance for industry have been issued by the FDA | Requires approval according to Federal FD&C Act, regulations for new animal drugs as stated in 2009 FDA Guidance for industry #187 (Draft guidance) and NEPA | Requires approval according to Federal FD&C Act, regulations for new animal drugs as stated in 2017 FDA Guidance for industry #187 (Draft guidance) and NEPA | ||
Canada | Allowed, food products of cloned animals and clone progeny are considered “novel foods” and require pre-market safety assessments according to the regulations in Division 28, Part B, of the Food and Drug Regulations (Novel Foods) | Requires approval according to the Canadian Environmental Protection Act, 1999, the New Substances Notification Regulations (Organisms) and Food and Drugs Act | No specific policy on gene editing, may be considered “novel” and require case-by-case safety assessment by Health Canada | ||
Argentina | Allowed | Requires approval according to animal biotechnology regulation, case-by-case assessment by CONABIA | Requires approval according to animal biotechnology regulation, case-by-case assessment by CONABIA | ||
Brazil | Allowed, commercial animal cloning mostly in partnership with EMBRAPA, registration of cloned cattle at ABCZ | Requires approval according to animal biotechnology regulation, case-by-case assessment by CTNBio | Requires approval according to animal biotechnology regulation, case-by-case assessment by CTNBio, GnEd animals lacking recombinant DNA are regarded non-GM according to Normative Resolution #16 | ||
Australia | Allowed, generally in confined research environment | Requires approval according to Gene Technology Act 2000, by OGTR | Requires approval according to Gene Technology Act 2000, by OGTR, gene editing techniques that do not introduce new genetic material are not regulated as GMOs | ||
Uruguay | No specific legislation on animal cloning performed in research institutes, such as Institute Pasteur in Montevideo and the Animal Reproduction Institute of Uruguay | No specific legislation on animal biotechnology. Environmental release of GMOs and biosecurity is subject to prior authorization by competent authorities, as stated in article 23 of law No. 17283 on the protection of the environment | No specific legislation on gene editing in animals, during a meeting of the CAS the minister of agriculture signed a declaration in favor of gene editing. GnEd animals may be subject to prior authorization according to law No. 17283 | ||