Table 4.

Comparisons and contrasts of regulatory approaches related to environmental risks of animal biotechnology among countries with GM or GnEd regulations in place

Country/union	CPBa party?	GM animals authorized?	GnEd regulatory approach in place?	GnEd animals authorized or deemed conventional?	Responsible Agency for animal biotech authorization	Supporting presentation
Argentina	No	No	Yes	Yes	CONABIAb	Boari (2020); Whelan (2020)
Australia	No	No	Yes; Third Review of National Gene Technology Scheme is in processc	No	Office of the Gene Technology Regulatord	–
Brazil	Yes	Mosquito, Salmone	Yes	Yes	CTNBiof	Garcia (2020a, b)
Canada	No	Pig, Salmong	NAh	No	Environment Canada	–
India	Yes	No	No	No	Ministry of Environment and Forests	Majumdar and Jain (2020)
Japan	Yes	Silkworm	Yes	No	Ministry of Environment	Ohsawa and Tsuda (2020)
New Zealand	Yes	Yesi	Yes	Yesj	Environmental Protection Authority	Strabala (2020)
Nigeria	Yes	No	No	No	National Biosafety Management Agency	Omeje and Gidado (2020)
Norway	Yes	No	No	No	Ministry of Climate and Environment	Holst-Jenson (2020)
Kenya	Yes	No	Yes, awaiting publication	No	National Biosafety Authority	Ogoyi (2020)
Philippines	Yes	No	No	No	NCBP, DOST, and DENRk	Salces (2020)
South Africa	Yes	No	No	No	Ministry of Agriculture, Forestry and Fisheries	Rhodes and Groenewald (2020)
United States	No	Salmon, Pig, Insectsl	Yes	Nom	HHS/FDA, USDA/APHIS, EPAn	–
European Union	Yes	No	No	No	European Food Safety Authority	Schoonjans et al. (2020)

^aCartagena Protocol on Biosafety, a follow-on to the Convention on Biodiversity

^bCONABIA—National Advisory Commission on Agricultural Biotechnology, within the Ministry of Agriculture, Livestock and Fisheries

^chttps://www1.health.gov.au/internet/main/publishing.nsf/Content/National-Gene-Technology-Scheme

^dGene Technology Act 2000

^eOxitec reproductively confined mosquito, AquAdvantage Atlantic salmon

^fCTNBio, the National Biosafety Technical Commission

^gAquAdvantage salmon

^hCanada’s regulations are product-based. The method of genetic modification does not determine whether a safety assessment is required; 'novelty' of product is regulatory trigger for pre-market assessment under the New Substances Notification Regulations (organisms) of the Environmental Protection Act (1999)

ⁱField trials of GM animals have been approved: high casein-expressing cattle, β-lactoglobulin knockdown cattle, monoclonal antibody-producing cattle and goats

^jContained production of pigs for improved human immunocompatibility

^kNational Committee on Biosafety of the Philippines, Department of Science and Technology, and Department of Environment and Natural Resources

^lAquAdvantage salmon, Gal-safe pig limited to a single biomedical facility with restrictions on rearing conditions and slaughter facility, insects with different traits for limited field trials

^mRulemaking in progress (U.S. Department of Agriculture—Animal and Plant Health Inspection Service 2020)

ⁿDepartment of Health and Human Services—Food and Drug Administration, U.S. Department of Agriculture—Animal and Plant Health Inspection Service, Environmental Protection Agency