EPA Seeks Comments on Monsanto’s Request for Experimental Use of Genetically-Modified BT Corn

Efthimios Parasidis

The Environmental Protection Agency has determined that Monsanto’s request to plant a new strain of genetically-modified corn “may be of regional and national significance.”  As a result, the agency is seeking public comment on Monsanto’s application.

Monsanto seeks permission to test the new corn in Puerto Rico and 22 states over the next two years.  The corn is bioengineered to produce Bacillus thuringiensis (BT)a bacteria that is known to kill rootworm.  The risks of BT-engineered crops are not fully known.  In addition to impacting the biodiversity of the soil and environment, BT toxin is known to kill other insects such as moths and butterflies, and some have argued that crops genetically-engineered to produce BT toxin have led to colony collapse disorder which has devastated beehives all over America for a number of years.

To be sure, naturally-occurring BT-products are allowed for USDA certified-organic production, and genetically modified BT-corn may be more environmentally friendly that other strains of genetically-modified corn since the corn itself produces the toxin, and thus theoretically would require less spraying of pesticides.  However, rootworm is known to adapt quickly and become resistant to bioengineered BT toxin.  In fact, farmers have had to spray their corn with chemical pesticides that the bioengineered BT corn was supposed to avoid. Notably, studies have found that genetically-modified BT crops adversely impact the health of humans and livestock, while BT toxin has been discovered in the blood of pregnant women and fetuses.  Given the widespread health and environmental concerns, to the extent the EPA is inclined to grant Monsanto’s request, the agency should condition the experimental use on funding for independent research that evaluates the long-term effects of bioengineered BT crops on humans, livestock, and the environment.

Variability in Local IRB Regulation: A Gold Mine for Future Research

When I moved to the University of Arizona, I quickly discovered something that I’ll politely call “heterogeneity” in Institutional Review Board’s (IRB) policies and practices.  All of a sudden, some of the rather vanilla human subjects research practices I had been doing for years, with IRB approval, were now forbidden.  Turns out that I had been exerting “undue influence” on human subjects all along by — wait for it — telling them how much I proposed to pay them.  (Good thing there is no IRB jail for miscreants like me.)

I’ve since learned that there is a scholarly literature about the tendencies of IRBs to vary in how they decide the same cases.  For example, Green and colleagues (2006) described their experience getting IRB approval for an observational study in 43 Department of Veterans Affairs medical centers.  They explain:

The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA … consent from physicians although no health information was asked of them. … Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.  Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions.

How can such disparate results come out of IRBs all applying the same Federal common rule?  And is that sort of variability justified by the 4,680 hours of staff time that Green reports spending navigating through this regulatory maze?  As I explain below the fold, this incident is not isolated.

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