CBI in APHIS Decision Documents

Many people, including those generally supportive of biotechnology, decry the apparently large amount of data and information in submissions marked “CBI” (confidential business information). Under this CBI stamp, all manner of data are hidden from public view and even from independent scientific scrutiny. This form of business information protection is not unique to the biotechnology industry and those who monitor the applications for approval of new pesticides by the agrochemical industry are faced with similar challenges. This committee sometimes found that it could not provide an independent scientific assessment of APHIS rulings because of the broad use of CBI. Clearly, businesses have the right and the need to protect sensitive information from their competitors. But APHIS does not have a mechanism to distinguish what is truly competitive information (and worthy of confidence) from less sensitive information that might be of value in the public discourse and open to scientific analysis. The lack of such a mechanism may be related to issues much wider than the APHIS regulatory system. However, its absence creates several contradictions. Without a transparent mechanism to evaluate and judge confidential data from applicants, APHIS appears to accept without question an applicant’s assertion of what is CBI. Public credibility is eroded when the same information marked CBI in APHIS documents is not considered CBI and is open to public inspection in other jurisdictions, such as Canada or Europe. It must be understood that U.S. standards for what constitutes CBI are very broad. A company can claim that certain information is CBI as long as it can show there is any possibility that disclosure of the information could directly or indirectly harm its business. In this legal sense APHIS may have little power to limit CBI. Another interpretation of the degree of CBI in documents sent to APHIS by applicants is that the agency is not working to provide as much information as possible to the public. Regardless of the accuracy of either of these interpretations, the extent of CBI in these documents makes public assessment of APHIS decisions extremely difficult.

Finding 5.4: The extent of CBI in registrant documents sent to APHIS hampers external review and transparency of the decision-making process.

Resistance Risk and Non-target Effects

For pesticidal plants, both APHIS and EPA examine risks of nontarget effects and the potential for pests to evolve resistance to the pesticidal component of the plant. The committee examined APHIS’s approach

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