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Intervention by Denise Caruso Read Intervention by Denise Caruso, Executive Director of the Hybrid Vigor Silver Award Winner, 2007 Independent Publisher Book Awards; Best Business Books 2007, Strategy+Business Magazine

HOW YOU GONNA KEEP ‘EM ON THE PHARM?

by Denise Caruso ~ April 8, 2007.
Permalink | Filed under: Hybrid Vigor, 21st Century Risk, Policy and Decisions, 'Intervention', Planetary Life.

Today, my ‘Re:framing’ column in The New York Times was on the scientific evidence that has been used by industry and the U.S. Agriculture Department to support safety claims about biopharma crops. These are the next generation of plants that have been genetically engineered to grow drugs and industrial chemicals in open fields in the U.S. and around the world.

The column is basically my entire book, Intervention, crammed into 1300 words. As a result I had to leave out some important stuff, so I decided to post some of it here.

One of the things I would have liked to dig into a bit was the USDA’s statement about the amount of scientific input the agency uses to develop its regulations.

As evidence, the person I spoke with mentioned that in 2002, the agency had commissioned a peer-reviewed National Academies study on the subject, called Environmental Effects of Transgenic Plants.

It was a curious example to choose. Because I read that report when I was writing Intervention, and it sure sounded to me like the USDA got handed its head on a plate.

National Academies reports are invariably written in a combination of academic and public-relations soft-shoe so as not to be offensive, particularly if they’re critical.

In that context, the headline on the official news release for Environmental Effects was positively blaring: “Regulation of Transgenic Plants Should Be Reinforced,” it said. “Field Monitoring for Environmental Effects Is Needed.” No equivocation at all.

The report dinged USDA’s Animal and Plant Health Inspection Service (APHIS) on many serious issues.

In addition to the problems about disclosure and transparency that I noted in today’s column, the report also said that APHIS didn’t evaluate environmental effects with enough rigor before approving them for commercial use, and that it needed to open up its risk assessment process to experts other than its own.

In fact, the authors said, if USDA wasn’t up to the job they should just give it to the Environmental Protection Agency and be done with it.

The committee also recommended that APHIS stop its policy of “deregulation for life,” which is its policy toward transgenic plants today. (That’s not how they put it, by the way.)

Today, once your transgenic and/or pharma plant is approved by USDA, it is no longer regulated. You need never come back for post-market testing, and you aren’t required to monitor the crop to see if your original risk assessment is holding up in the field.

If you’d like, you can read the Executive Summary for yourself.

Five years later, it appears as though the agency has not done much to address the National Academy’s recommendations.

On February 14th, for example, the USDA got a Valentine’s Day spanking by a San Francisco judge who found the agency in violation of the law for its “cavalier” attitude toward the environmental effects of a transgenic alfalfa crop. (Subscription required for the NYT link.)

As for the obviously riskier pharma crops: despite protests from its own research personnel, USDA permitted Ventria to plant several acres of biopharma rice virtually next door to a USDA rice quarantine nursery in North Carolina.

The purpose of a quarantine center is fairly obvious. In this case, its job was to keep harmful genes out of the domestic rice supply.

One of the scientists who protested the Ventria siting is chair of a national rice germplasm committee. The other is a research leader in the USDA’s own Plant Science Research Unit.* Their statements were submitted to a USDA docket in 2005 when the department invited public comments on its preliminary approval for Ventria’s rice.

According to the Union of Concerned Scientists, it obtained USDA records through FOIA that “document the agency’s apparent failure to adequately monitor and inspect pharmaceutical rice fields in North Carolina—even after a hurricane blew through the area, potentially contaminating a nearby rice breeding facility.”

(For the record, USDA disagrees with UCS’s reading of the documents; UCS refutes the refutation.)

* (Or at least they were; I don’t know where they are today.)

4 Responses to HOW YOU GONNA KEEP ‘EM ON THE PHARM?

  1. Sylvia S Tognetti

    I blogged about and linked to your NYT article at The Post-Normal Times (here. Also, after a commenter let me know about this blog, blogrolled it. Delighted to find another blog with a similar perspective, and I look forward to reading more.

  2. Krys Cail

    My NY Times “Agriculture” newstracker brought your article into my email inbox today- it was great to read your article, and I was thrilled to be able to start following the trail back from your byline to Hybrid Vigor’s website and more information about your work. I am very, very interested in what you are doing, and excited to have come across all of these new resources.

    This is the work that the US Office of Technology Assessment should be doing…. if it had not been disbanded years ago… how wonderful that you have found funding to carry on this essential function! Your blog has earned a spot in my toolbar bookmarks folder already- and I look forward to reading more.

  3. Denise Caruso

    Thanks to both of you for your very kind comments, and I hope you’ll spread the word about the blog. I haven’t been very rigorous about keeping it updated but of course, a larger audience is great incentive!

    Kris, you are dead right about the late lamented OTA. In fact, the conclusion of my book, Intervention (which the NYT won’t let me mention for fear of self-promotion), is all about how we need a new OTA for biological policy.

    I very cleverly called it BIOTA. ;)

  4. Krys Cail

    Ordered the book, but it has not yet arrived… I guess the need for OTA has been pretty clear to me for years; still more so in the age of biotechnology. But, reading Lawrence Lessig can convince one that even the non-self-replicating tech stuff is worth a certain degree of public-minded scrutiny.

    Did you see that Hillary Clinton, has decided that reinstituting OTA is one of her 10 Points for governmental reform? It’s reported here: http://www.nydailynews.com/blogs/dailypolitics/2007/04/hillarys_10point_reform_plan.php#comments

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