Table 1. Comparison of Non-Target Organism Testing for GEIR Crops in Six Jurisdictions.

	Argentina	Brazil	EU	Mexico	Philippines	United States
Number of Bt events approved for unconfined release	Maize: 9 Cotton: 1 Soybean: 1	Maize: 15 Cotton: 7 Soybean: 1	Maize: 1	Cotton: 2	Maize: 8	Maize: 10 Cotton: 7 Soybean: 1
Field studies are required for each event or subset of events submitted for unconfined release	Field studies to assess NTO are not required; the need for field studies is determined on a case-by-case basis.	Yes, field studies are required to assess NTO impacts, for each event to be submitted for commercial release.	Field studies are not required if (1) lower tier studies do not indicate negative effects and (2) lower tier studies were performed with plant material for one focal species per relevant functional group	Yes	Yes, data from local field studies are required.	No. This is determined based on a tiered testing scheme but may also be required for other reasons on a case-by-case basis.
Tiered testing is addressed in regulations or guidelines	No	Yes, in guidelines.	Yes, in guidelines.	No	Yes, in guidelines	Data requirements have been based on requirements for microbial pesticides, and additional data have been required where necessary.
Standard Operating Procedures for NTO testing are addressed in regulations or guidelines	No specific SOPs are provided in the regulations.	No specific SOPs are provided, but they are discussed in guidelines.	No SOPs are provided, but general requirements for testing are described in guidelines.	No	Applicant submits SOPs for approval. Tiered testing is discussed in guidance.	There are no official SOPs or guidelines published for plant-incorporated protectants*
NTO species that must always be included in risk assessments	No NTO species are required to be assessed.	No NTO species are required to be assessed.	No NTO species are required to be assessed.	None currently, but a list is being compiled	Orius sp , Micraspis discolor, Chrysoperla carnea, Chilomenes sexmaculata	Honey bees, Monarch butterflies in specific cases.
NTO species that are typically included in risk assessments	Species included are determined on a case-by-case basis.	Doruluteipes sp (Forficulidae: Dermaptera) and at least one Heteropteran are expected to be included.	Three or more NTO species (e.g., Chrysoperla carnea, lady beetle, parasitic wasp, carabid beetle, Orius sp), Apis mellifera	None currently, but a list is being compiled.	Trichogramma sp, Apis sp, Coccinella septempunctata, Euborellia sp, Geocoris sp, Hypolimnas bolina, Selenopsis germinata, carabid beetle, spider, braconid wasp	Northern bobwhite, rainbow trout or channel catfish, Daphnia magna, three or more nontarget insects (e.g., Chrysoperla carnea, lady beetle, parasitic wasp, carabid beetle, Orius sp), Apis mellifera.
Data developed outside the country is used in NTO impact assessments	Yes, if applicants demonstrate that for a particular trait and crop the risk hypothesis performed for NTO species in the Argentinean receiving environment can be assessed by the studies done in another country.	Yes, data developed outside can be used, however insects tested outside the country should be similar (e.g., same genera)	Yes, non-European species that represent species present in the European agro-ecosystems can be used in the NTO assessment, if justified.	Yes, on a case-by-case basis.	Yes, if data adheres to international protocols, guidelines and best practices.	Yes, as long as it meets USEPA standards.*
Link to regulations	http://64.76.123.202/site/agregado_de_valor/biotecnologia/60-SOLICITUDES/___experimental/index.php	http://www.ctnbio.gov.br	http://www.efsa.europa.eu/en/efsajournal/doc/1877.pdf http://www.efsa.europa.eu/en/efsajournal/doc/1879.pdf	NA	http://biotech.da.gov.ph/Forms.php.	NA

^*See, e.g., reference 10.