TABLE A.7 Estimated Costs of Regulatory Testing for Transgenic PestProtected Plants in 1998 Dollars


EPA Estimated Testing Costs

Increment in Breakeven Expected Annual Sales

Baseline data requirements:

Product analysis, including crop residues



Biological fate (basic)



Acute oral toxicity and digestibility






Biological fate:

Tier IIa



Tier IIIb






Human health and mammalian toxicology:

Hypersensitivity and specific-allergen testing



Tier II (microbial)cs



Tier III (microbial)d






Nontarget organisms:

Tier Ie



Tier IIf



Tier IIIg






a tests for hybrid and pollen viability

b tests for selective advantage (host range and growth and development) and dispersion (including field testing)

c tests for acute and subchronic toxicity/pathogenicity

d tests for reproductive effects, oncogenicity, immunodeficiency, and primate infectivity/ pathogenicity

e tests for honey bee toxicity, avian oral LD50, avian dietary LC50, and nontarget insect effects.

f tests for freshwater fish LC50, acute freshwater organisms EC50, and acute estuarine and marine organism LC50.

g tests for avian reproduction

cate that the costs of providing data to meet regulatory requirements for Bt corn amounted to nearly $3.8 million in addition to 21.5 person-years of staff time.

If pesticidal substances in transgenic plants were not considered pesticides for purposes of FIFRA and the FFDCA, it is possible that the costs associated with the FDA process would increase. In particular, for at least

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