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International Biotechnology Issues Management

(Modified from and with gratitude to the National Oilseed Processors Association document on deregulation of specific biotech soybean events).

NAMA remains committed to and believes that the responsible use of biotechnology can play an important role in production agriculture. To that end, NAMA expects biotechnology providers to deploy prudent and comprehensive risk management through effective and responsible stewardship programs.

NAMA supports the U.S. regulatory structure under which the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has a responsibility to carefully review products of modern biotechnology ahead of deregulation on a case-by-case basis to clearly understand the direct and indirect impacts on the diverse interests of U.S. agriculture. NAMA further maintains that this careful review should include an understanding of the impacts of USDA decisions on agricultural stakeholders and that this review should extend to the deregulation of products with unique functional characteristics (hereafter referred to as PUFCs) and referred to as “Special Use Traits” by the Biotechnology Industry Organization (BIO). We agree that as part of the review of a PUFC, APHIS should consider scientific data assessing the risks to food functionality, a commitment to a risk management plan that minimizes impacts to existing supply chains, and a commitment to risk responsibility in its review of the new class of output traits.

A key element for NAMA’s support for any request for a “determination of nonregulated status” by USDA/APHIS will be based upon the technology provider’s commitments to the responsible commercialization of the product and U.S. grain processors and stakeholders specifically relating to: (1) Risk Assessment, (2) Risk Management and (3) Risk Responsibility.

Risk Assessment
NAMA believes that the technology developer must be responsible to make this risk assessment data publicly available to NAMA and its members, as well as submit this summary information as part of the public record. This information is critical for stakeholders to properly assess the impacts of this product in agricultural systems and can be useful to inform the relative robustness of the developer’s risk management plan.

Risk Management
Based on this risk assessment, we believe that ultimately the developer must be held accountable for the management of its overall supply chain, especially if the level of impact data proves to be inaccurate or if its risk management plan is not effectively managed and/or any closed loop systems fail. Given the level of potential negative impact that is defined for PUFCs, the developer may design a form of closed-loop product management to keep the commodity segregated and ensure that it does not escape into the commodity supply chain above the impact level/threshold.

Risk Responsibility
A critical element of overall product stewardship is risk responsibility. NAMA strongly believes that when a technology developer fails to effectively assess and/or manage its product impacts, it must accept responsibility for direct economic damages to downstream stakeholders caused by their failure to effectively manage the novel product. If the developer does not recognize the need to accept responsibility for supply chain disruptions that are caused by negligence in executing against the overall risk management plan, NAMA will have no choice, but to oppose the deregulation. While individual firms will always take independent action, it is the industry organization’s responsibility to advocate for policies that minimize threats to the milling industry’s operations.

NAMA will only support responsible commercialization that includes a commitment to taking responsibility for its overall supply chain to safeguard a developer’s premise that its product(s) can be effectively channeled in a manner that is minimally disruptive to U.S. grain processor’s interests and other stakeholders.

Last updated September 2011

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