170 CHAPTER 6


TABLE 6.7 Estimated costs for biosafety activities for India, China, and the United States (US dollars)


United States Activity Pre-approval


Molecular characterization Toxicology (90-day rat trial)


Allergenicity (Brown Norwegian rat) Animal performance and safety studies Poultry-feeding study


Goat-feeding study (90 days) Cow-feeding study


Water-buffalo feeding study Fish-feeding study


Anti-nutrient Gene flow


Baseline and follow-up resistance studies (ELISA) Protein production/characterization Protein safety assessment Non-target organism studies


ELISA development, validation, and expression Composition assessment


Limited, multilocational, and/or large field trials Socioeconomic studies


Facilities, management, salaries, and other overhead costs


Total pre-approval Post-approval


Socioeconomic study Resistance study


Integrated pest-management package


Facilities, management, salaries, and other overhead


Total post-approval Total


30,000 — 20,000 — 20,000 — 125,000 —


195,000 —


— — — —


—


— — — —


— 1,990,000 — 3,180,000 12,550,000


Sources: Estimates for the United States from Kalaitzandonakes, Alston, and Bradford (2007); those for India from Pray, Bengali, and Ramaswami (2005); those for China from Pray et al. (2006).


Note: The data shown for the United States represent the average of the minimum and maximum for each activity across all responding firms in the author’s survey. — = not applicable; ELISA = enzyme-linked immunosorbent assay.


— —


— 14,500


150,000 — —


—


5,000 — 55,000 — 10,000 — 10,000 — 5,000 — —


40,000


20,000 — — — — — —


— —


11,600 — —


585,000 — 15,000 —


900,000


300,000 1,200,000 250,000 —


300,000 —


1,200 11,200


300,000 — — — — — — — —


840,000 — — — — — — — —


160,000 1,700,000 190,000 100,000 400,000


850,000 600,000 600,000


750,000 1,500,000 130,000 —


460,000 —


600,000 4,500,000 1,795,000 — 3,180,000 12,550,000 India China Minimum Maximum


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