4 Ways the Biotech Industry is Taking Over GMO Regulation from the Inside

Jonathan R. Latham July 24, 2017

A statue of the Roman goddess Minerva in Guadalajara, Mexico. In June 2017, the city hosted the 14th International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO14)—an increasingly corporate affair.

The British non-prof­it GMWatch recent­ly revealed that agribusi­ness has in effect tak­en over Conabia, the Nation­al Advi­so­ry Com­mit­tee on Agri­cul­tur­al Biotech­nol­o­gy of Argenti­na. Conabia is the GMO assess­ment body of Argenti­na. Accord­ing to GMWatch, 26 of 34 its mem­bers were either agribusi­ness com­pa­ny employ­ees or had major con­flicts of interest.

Pack­ing a reg­u­la­to­ry agency with con­flict­ed indi­vid­u­als is one way to ensure speedy GMO approvals and Conabia has cer­tain­ly deliv­ered that. A much more sub­tle, but ulti­mate­ly more pow­er­ful, way is to bake approval into the struc­ture of the GMO assess­ment process itself.

It is eas­i­er than you might think.

In June, I attend­ed the lat­est inter­na­tion­al con­fer­ence of GMO reg­u­la­tors, called ISBGMO14, in Guadala­jara, Mex­i­co. ISBG­MO is run by the Inter­na­tion­al Soci­ety for Biosafe­ty Research (ISBR). In 2007, when I first attend­ed this bien­ni­al series of con­fer­ences, just one pre­sen­ta­tion in the whole four days was by a com­pa­ny. ISBR had some aspi­ra­tions towards sci­en­tif­ic inde­pen­dence from agribusiness.

In 2011, I went to the ISBG­MO held in Buenos Aires, Argenti­na. Com­pa­ny researchers and exec­u­tives were fre­quent speak­ers, and the con­fer­ence had become an oppor­tu­ni­ty for agribusi­ness to present talk­ing points and reg­u­la­to­ry ini­tia­tives as if they had the bless­ing of science.

This year, in Guadala­jara, com­pa­nies were now on the con­fer­ence orga­niz­ing com­mit­tee and con­fer­ring con­fer­ence trav­el schol­ar­ships for those attend­ing. A for­mer con­fer­ence orga­niz­er and ISBR board mem­ber told me that the pre­vi­ous ISBG­MO (St. Louis in 2015) had been almost entire­ly paid for by Monsanto.

Spread­ing the indus­try message

In Guadala­jara, indus­try speak­ers were clear­ly work­ing from a script­ed list. That list trans­lates as the key reg­u­la­to­ry objec­tives of the biotech industry.

On the top of that list is data trans­porta­bil­i­ty.” Data trans­porta­bil­i­ty is the idea that reg­u­la­tors from dif­fer­ent juris­dic­tions, say India, or the EU, should accept iden­ti­cal biosafe­ty appli­ca­tions. Imple­men­ta­tion of data trans­porta­bil­i­ty would mean that although each coun­try has unique ecosys­tems and species, appli­cants ought not to have to pro­vide stud­ies tai­lored to each. For exam­ple, when it comes to assess­ing effects on non-tar­get bio­log­ic organ­isms, for exam­ple the effects of a GMO crop pro­duc­ing an insec­ti­cide, reg­u­la­tors in Aus­tralia should accept tests on Euro­pean lady­bird species or earth­worms as show­ing that a GMO cot­ton can safe­ly be grown there.

The appeal of data trans­porta­bil­i­ty for an appli­cant is clear enough — less cost and less risk of their GMO fail­ing a risk assess­ment. Not once did I hear men­tion of an obvi­ous down­side to data trans­porta­bil­i­ty. The few­er tests to which a nov­el GMO is sub­ject­ed the less research there is to detect a sig­nif­i­cant prob­lem if one exists.

A sec­ond stan­dard cor­po­rate line was need to know ver­sus nice to know.” In oth­er words do not ask appli­cants for more data than they wish to sup­ply. The down­sides to this are iden­ti­cal to data trans­porta­bil­i­ty. Less data is less test­ing and less science.

Mod­ern­iz­ing risk assessment?

A third major theme of the meet­ing was mod­ern­iza­tion” of reg­u­la­tion. In this scheme the most advanced” nation was pro­posed to be Canada.

Cana­da has adopt­ed what it calls trait-based GMO reg­u­la­tion.” In trait-based reg­u­la­tion the method of devel­op­ment (i.e. whether the crop was genet­i­cal­ly engi­neered or not) is con­sid­ered irrel­e­vant. The trait is the sole focus. So if a GMO crop con­tains an insec­ti­cide it is assessed for risk against non-tar­get organ­isms. If a GMO improves fla­vor or nutri­tion then, since there is pre­sum­ably no risk from fla­vors or nutri­ents, then the crop receives what amounts to a free pass.

The Cana­di­an approach sounds harm­less, but it has the cru­cial attribute of hand­ing con­trol of risk assess­ment to the appli­cant, because under such a sys­tem every­thing depends on what the appli­cant choos­es to call their trait. Imag­ine you were asked to review the safe­ty of an air­craft, but the man­u­fac­tur­er wouldn’t tell you if it was pro­peller-dri­ven or a jet; like­wise, if a sub­ma­rine was diesel or nuclear powered.

The Cana­di­an approach there­fore, by just ask­ing what the crop is sup­posed to do, effec­tive­ly places out­side of reg­u­la­tion most of the stan­dard con­sid­er­a­tions of risk and haz­ard. Once upon a time, risk assess­ment was sup­posed to be about what a prod­uct is not sup­posed to do. For propos­ing non-reg­u­la­tion over reg­u­la­tion, Cana­di­an biosafe­ty offi­cials were giv­en more promi­nent speak­ing oppor­tu­ni­ties at ISBGMO14 than any oth­er nation­al regulator.

Tiered risk assessment

A fourth, and equiv­a­lent­ly unsci­en­tif­ic inno­va­tion, that seems wide­ly accept­ed, is called tiered risk assess­ment. Imag­ine a com­pa­ny presents to reg­u­la­tors an insect-resis­tant GMO crop. An obvi­ous ques­tion aris­es. How is a reg­u­la­tor to know, since the crops pro­duces an insec­ti­cide, if it will kill ben­e­fi­cial organ­isms such as the bees that feed on its flowers?

In tiered risk assess­ment this ques­tion is answered by feed­ing the puri­fied GMO insec­ti­cide to a bee species. If no harm is observed the crop is assumed safe. No fur­ther tests are required. If the bees are harmed then a larg­er scale test, pre­sump­tive­ly more real­is­tic, is con­duct­ed. If harm is not observed the crop is assumed safe and no fur­ther tests are required. If harm is shown then an out­door or larg­er-lev­el test will be conducted.

Mon­san­to pre­sent­ed a lengthy expo­si­tion, in a ple­nary ses­sion, of the sound­ness” and log­ic” of this tiered approach. Tiered risk assess­ment has been the sub­ject of lit­tle sci­en­tif­ic debate (though see Lang et al., 2007), but the impli­ca­tions of the tiered approach are pro­found. It is an asym­met­ri­cal sys­tem in which pass­ing any test leads to approval where­as fail­ing that test does not result in disapproval.

Con­sid­er the com­par­i­son with phar­ma­ceu­ti­cals. Cur­rent­ly, all phar­ma­ceu­ti­cal drugs must pass through three phas­es of clin­i­cal tri­als; first ani­mal tests, then small-scale human tri­als, then large scale human tri­als. Fail­ure at any stage is con­sid­ered ter­mi­nal. With­out wish­ing to give them any ideas, sup­pose the FDA were to replace this three-phase sys­tem with one under which approval in phase I (ani­mal tests) allowed the devel­op­er to go straight to mar­ket. There would be, for good rea­son, an uproar fol­lowed by an avalanche of dan­ger­ous med­ica­tions on the mar­ket. But that is pre­cise­ly the log­ic of tiered GMO testing.

Tiered test­ing is there­fore a sys­tem in which fail­ure is an unac­cept­able answer. The 2008 sci­en­tif­ic review paper that first pro­posed tiered risk assess­ment made no pro­vi­sion for reject­ing the crop in the dia­gram of the pro­posed tiered-risk-assess­ment deci­sion tree. Approvals are guar­an­teed. Agribusi­ness knows this per­fect­ly well because many of the prin­ci­pal authors of the paper are from the major seed and biotech companies.

The so-called log­i­cal inno­va­tions pre­sent­ed at ISBGMO14, such as the above men­tioned data trans­porta­bil­i­ty, trait-based reg­u­la­tion and tiered risk assess­ment, along with reg­u­la­to­ry mod­ern­iza­tion, are thus intend­ed as reg­u­la­to­ry bypass­es. They make it all but impos­si­ble for a reg­u­la­tor to turn down a GMO appli­ca­tion, or even to col­lect suf­fi­cient infor­ma­tion. No won­der the biotech indus­try likes to refer to risk assess­ment pro­ce­dures as approval systems.

Giv­en the lack of objec­tion to these approach­es at ISBGMO14, the biotech indus­try ought now to feel con­fi­dent that the reg­u­la­tion of biotech­nol­o­gy is large­ly in their hands, yet still it wants more.

In the com­ing years, an upsurge is expect­ed in the GMO pipeline as new appli­ca­tions and new approach­es become pos­si­ble. This pipeline is pre­dict­ed to include GMO algae, ani­mal biotech­nol­o­gy, gene dri­ves and so forth. Many of these oppor­tu­ni­ties the indus­try knows will be con­tro­ver­sial. The indus­try also knows that a paci­fied reg­u­la­to­ry envi­ron­ment is a pre­req­ui­site for such GMO inno­vata­tions” to get to market.

This is more than a shame. At a time when a com­pre­hen­sive eval­u­a­tion of the weak­ness­es and inher­ent lim­i­ta­tions of sci­en­tif­ic risk assess­ment is urgent­ly need­ed to cope with these chal­lenges, the chem­i­cal and biotech indus­tries are forc­ing those assess­ment sys­tems in the oppo­site direction.

(“The Biotech Indus­try Is Tak­ing Over the Reg­u­la­tion of GMOs from the Inside” was orig­i­nal­ly pub­lished on Inde­pen­dent Sci­ence News and is repost­ed with per­mis­sion from the author.)

Jonathan R. Lath­am, PhD, is co-founder and exec­u­tive direc­tor of the Bio­science Resource Project, which is the pub­lish­er of Inde­pen­dent Sci­ence News (inde​pen​dentscience​news​.org). He has pub­lished sci­en­tif­ic papers in dis­ci­plines as diverse as plant ecol­o­gy, virol­o­gy, genet­ics, and RNA biology.
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