The standard for regulatory design is to have clear rules and standards for implementation and decision making. If there are no rules or standards for decision making, or alternatively, these are not clear or are confusing, this can lead to an unworkable system which may be unable to render a decision or make it unnecessarily difficult to comply with existing regulations.
The latter has a much stronger impact on public sector and small private firms that may not have the resources compared to multi-national corporations to meet a biosafety regulatory process. Yet, this note is not about contrasting a corporation with a university or a national research organization. This note is really intended to ensure that all developers, users and society in general develop a fair process that will contribute to improving society’s welfare.
Let’s contrast the approaches taken by two distinct countries: Argentina and Brazil. In Argentina a socio-economic assessment is mandatory for all applications. The socio-economic study has a distinct and clear objective which is to examine impacts on Argentinean exports and trade. The study is conducted by a unit within the Minister of Finance and Trade. This approach is apparently undergoing a review that may expand the scope of the socio-economic assessment as more crops for domestic use enter the regulatory process.
In contrast, Brazil the inclusion of socio-economic considerations is an optional step after the biosafety risk assessment has been completed by the assessment agency. The socio-economic assessment study is commissioned by the decision making body, if and only if, socio-economic considerations were raised during the risk assessment. The decision-making body then commissions a socio-economic study to a third party.
These two examples show that the issue is not whether it is mandatory or voluntary, but having clear rules and a decision making standard!!! In most situations, the best alternative is to have rules and standards for implementation and decision making in implementing regulations. This is extremely important as the need may arise of changing procedures later on as the regulatory system gains experience and familiarity with products in the regulatory pipeline. Having an unworkable system, or one that cannot render a decision in a timely, cost efficient manner and whose decision is robust, protective and accepted by society; is not a desirable outcome and is a questionable use of scarce societal resources.