Grain industry groups are concerned about a new rule being proposed by USDA's Animal and Plant Health Inspection Service (APHIS) that could affect biotechnology traces content policy.
APHIS has proposed a rule that establishes a separate component within its regulatory system to address the adventitious presence of biotech-enhanced commodities that have not yet received full regulatory approval for food or feed. APHIS has also requested comments on whether it should exempt "low-level" occurrences of such biotech-enhanced events in commercial crops, food, feed or seed.
The National Grain and Feed Association (NGFA), North American Export Grain Association (NAEGA), Biotechnology Industry Organization (BIO) and 17 state and regional gain and feed associations affiliated with the NGFA sent joint comments urging APHIS to work with the Environmental Protection Agency (EPA) and the Food and Drug Administration on a rule that would not harm U.S. producers or foreign markets. The group urged the regulatory agencies to expedite the implementation of an overarching, science-based policy governing incidental, trace amounts - or so-called "adventitious presence" - of biotechnology-enhanced events in raw and processed grains and oilseeds, as well as food and feed.
Their comments explained that implementation of such a policy for biotech-enhanced commodities is "enormously important" and a "vital" precursor to the United Statesâ€™ providing international leadership to develop a harmonized global approach on the issue. "Such a policy must be solidly grounded in science, involve all agencies with regulatory responsibilities for biotechnology, and not compromise the safety of the U.S. food and feed supply or the environment," the groups said.
The organizations also insisted that such an early safety assessment policy maintain stringent regulatory safeguards and be restricted to those biotech events (specific gene sequences) for which the sponsors seek regulatory approval for use in the general commodity stream for food and feed use. Biotech-enhanced plants intended for pharmaceutical or industrial uses would not be covered by this policy unless they are deregulated for general commodity use in food and feed.
Contamination can accidentally occur through the plantâ€™s natural physiology (pollen flow) or inadvertent mixing during harvest and transportation. But they note that the U.S. regulatory system imposes a zero tolerance on the presence of such unapproved biotech-enhanced events in food and feed, regardless of the risk level. "This 'zero-tolerance' policy exposes grain handlers, food processors and feed manufacturers to the risk that any presence in general commodity crops of biotech-enhanced events that have not been approved for food and feed under the U.S. regulatory process could render such crops adulterated and subject to seizure under federal law," the groups said. Such risks are even more complex for agricultural exporters, which confront a lag time in biotech approvals by foreign governments, they say. Further, the groups subsequently note that this policy is inconsistent with other food regulations that have established thresholds for trace amounts of unexpected materials.