The simple answer is that more than half the states have had measures introduced mandating labeling of so-called genetically-modified organisms (G.M.O.s). While such measures have been defeated, the state-by-state battles have been costly, and the prospect of a hodgepodge of labeling laws disrupting interstate commerce is unattractive. But the issue goes much deeper than that.
Two fundamental problems seem to underpin this continuing controversy. One is conceptual; the other is regulatory.
The conceptual issue involves the purpose of mandatory — as opposed to voluntary — labels. Governments typically require labels when there is a scientific judgment that consumers need to know something. The Surgeon General’s warning on cigarettes is a clear example. On foods, government has required labeling of calories, fat content, nutritional data and — where necessary — possible allergens.
Right to know?
Advocates of G.M.O. labeling argue that consumers have a right to know something. While this sounds reasonable, it is a different claim and one that risks confusion more than clarification. Consumers may interpret a mandated G.M.O. label as a science-based warning, as necessary because consumers need to avoid the food. That would be a misinterpretation, as the Food and Drug Administration (F.D.A.) has found bioengineered products “as safe as” their conventional counterparts. Mandating a “contains G.M.O.s” label could end up misleading consumers. It also could undermine the F.D.A.’s use of science to determine safety by seeming to invite consumers to substitute their own judgments on safety for those of experts.
Producers of organic foods also have endorsed mandatory G.M.O. labels, even though they already had urged the U.S. Department of Agriculture to make “non-G.M.O.” one of the criteria for “certified organic” labeling. Consumers who want to avoid bioengineered ingredients can purchase certified organic products, but they typically have to pay a premium for that choice. A mandatory G.M.O. label could either drive consumers toward organic products in spite of their cost or, as in Europe, compel manufacturers to reformulate their products with non-bioengineered ingredients, likely narrowing the price spread between conventional and organic products.
The regulatory issue also perpetuates the labeling controversy. Currently, products containing bioengineered ingredients have come to market through F.D.A.’s “generally recognized as safe” (GRAS) pathway. This pathway does not require F.D.A. product approval prior to marketing, nor does it require prior F.D.A. review of safety data (although in practice providers of bioengineered seeds have submitted their products to the F.D.A. for such review prior to marketing). The absence of a mandatory prior approval is unlikely to reduce levels of mistrust of biotechnology or of its corporate providers.
On the other hand, the only other current pathway to approval is the lengthy, costly “food additive” avenue. High costs and risks of lengthy delays are disadvantageous to biotechnology providers. And, at the end of a successful review, the product would be branded as an additive, not as a food “substantially equivalent” to its conventional counterpart as under the GRAS approach. That characterization could be a disadvantage in the marketplace and misleading to consumers.
Finding a new pathway to market
With biotechnology firms understandably reluctant to go the food additive route and public interest groups and organic associations distrustful of the GRAS approach, the logical solution to this regulatory problem would be a new pathway to market for biotechnology products. H.R. 4432 provides this. It requires biotechnology providers to notify F.D.A. of their plans to market a potentially new ingredient and to provide their safety data on it. Importantly, it further requires the F.D.A. to approve or disapprove the trait within a specified time frame, and it empowers the Secretary of Health and Human Services, on the F.D.A.’s recommendation, to require a label where the product is materially different than its conventional counterpart.
In other words, H.R. 4432 directly addresses both the conceptual and regulatory issues that have encumbered bioengineered food ingredients. It reserves mandatory labels for those circumstances when scientific experts have determined a need to know while offering guidelines for manufacturers who wish to respond to consumers’ right to additional product information. It creates a new regulatory pathway for biotechnology products that guarantees review and prior approval without imposing the unnecessary branding of the food additive pathway.
It will be interesting to see if this legislation calms the roiled G.M.O. waters. So far, the warring parties have taken predictable positions in favor and opposition, but the debate and discussion have only just begun.