[Paracelsus] fwd: Regulatory Sham on Bt-Crops (fwd)

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ISIS Press Release 01/12/03

Regulatory Sham on Bt-Crops

<mailto:jcummins@...>Prof. Joe Cummins exposes

the regulatory sham involved in GM crops

containing a range of biopesticides

At 80 million planted acres, corn is the largest

crop grown in the US and accounts for one fifth

of total agricultural cropland. Over the past

years, conventional insecticides have been

applied to between 14 to18 million acres of corn

to control corn root worm (CRW). This single corn

pest accounts for over 14% of insecticide

applications to agricultural crops. Infested

acreage is increasing due to extended diapause

and change in the insect's behaviour as the CRW

lays its eggs in soybean fields, which are

planted in rotation with corn.

Currently, the main genetically modified (GM)

corn contains the Bacillus thuringiensis (Bt)

toxin gene Cry1Ab to control corn borer, but does

not control CRW. CRW control has been the recent

focus among the corporations developing GM crops.

All candidate crops are being raced to market

with the cooperation of regulatory authoritatives

in the US and Canada. The emphasis is on speedy

evaluation and keeping down costs rather than to

ensure safety to consumers and to the

environment. Safety testing is done using toxins

produced in bacteria acknowledged to be somewhat

different from those produced in the corn plants.

This is deemed to be " sound science " by the

regulators.

GM corn with genes providing protection against

CRW will soon reach the market. Monsanto

corporation has focused on the Bt toxin Cry3Bb

and has recently developed synthetic Bt toxins

that combine amino acid sequences from native

Cry1Ac and Cry1F crystal protein, which have

enhanced broad range specificity lacking in

either toxin individually. Dow corporation has

been developing corn with Cry34Ab/Cry 35Ab

combined toxin. Monsanto's Cry3Bb-corn is ready

for commercial release and the others will soon

follow.

Patents describing the production of Bt-Cry3Bb

describe the production of the synthetic Bt genes

both used to produce the toxin produced in

bacteria and the toxin produced in corn plants

[1,2]. The synthetic Bt-cry3Bb is altered from

the bacterial gene by insertion of the

cauliflower mosaic virus (CaMV) promoter and

enhancers, the leader sequence of wheat

chlorophyll a/b binding protein, the rice actin

intron, and the 3’ transcription terminator

sequence of wheat heat shock protein 17.3. Along

with the sequences above, many code words for

amino acids were altered to enhance translation

in the plant cell, and some amino acids were

changed to enhance performance in the plant cell.

An antibiotic resistance marker nptII, also with

the CaMV promoter and the NOS transcription

terminator from Agrobacterium tumefacians

nopaline synthetase gene was inserted into the

corn chromosome along with the Bt-cry3Bb

construct The genetic insert in corn was called

MON 863. The US Food and Drug Administration

(FDA) noted that the Bt toxin in Mon 863 differed

from the bacterial toxin by seven amino acids and

by an additional amino acid, alanine in the

second position from the start of the protein [3].

US Environment Protection Agency has considered a

large number of documents on human health and

environmental impacts of Mon 863 corn. The

petition to establish a tolerance exemption for

Bt-Cry3Bb argued that it was not necessary to set

a tolerance level because the toxin was not toxic

to mammals. But the studies supporting the

exemption were done with toxin produced in

bacteria that are not identical to the product in

Mon 863 corn [4]. The biopesticides registration

action document for event MON863 Bt-Cry3Bb1 corn

provided information on product characterization

[5]. The action document on environmental

assessment included evidence on non-target

wildlife, but reviewed data from the bacterial

Bt- Cry3Bb1 toxin, and not the toxin produced in

MON863 corn. EPA has also provided a fact sheet

on Bt-Cry3Bb1 protein and the genetic material

necessary for its production [6].

Canada approved MON863 corn for livestock feed on

March 5, 2003 [7]. Limited information was

provided in the Canadian decision document, and

the fact that the safety investigations had been

based on a product significantly different from

the toxin in MON863 corn was not mentioned. The

approval of GM crops bearing toxins whose safety

tests have been based on tests of surrogate

products appears to have grown so commonplace

among regulators that it is not worthy of mention.

Dow Agroscience Corporation has been developing a

binary toxin mixture containing Bt- Cry34Ab1 and

Bt-cry35Ab1 effective against CRW [8,9]. Initial

safety tests using toxins produced in bacteria

showed that the mixture was digestible by mammals

and for that reason unlikely to be allergenic

[10]. The petition to EPA for tolerance

exemption, and the granted temporary exemption

[12] noted that the proteins were obtained from

bacteria but believed to be similar to the

proteins produced in corn (the product being

regulated) because the products had similar gel

electrophoresis mobility. The actual differences

between the synthetic genes in corn and the

protein they produce and the protein toxins

produced in bacteria from the native gene have

not yet been disclosed.

Monsanto recently (Nov. 11,2003) disclosed

methods for the construction of B. thuringiensis

hybrid delta-endotoxins comprising amino acid

sequences from native Cry1Ac and Cry1F crystal

proteins. These hybrid proteins, in which all or

a portion of Cry1Ac domain 2, all or a portion of

Cry1Ac domain 3, and all or a portion of the

Cry1Ac protoxin segment is replaced by the

corresponding portions of Cry1F, possess not only

the insecticidal characteristics of the parent

delta-endotoxins, but also have the unexpected

and remarkable properties of enhanced broad-range

specificity not displayed by either of the native

delta-endotoxins. The hybrid toxins incorporated

into transgenic plants express broad-spectrum

insecticidal activity against a variety of

coleopteran, dipteran, and lepidopteran insects

[13]. Presumably, the deployment of the synthetic

genes, described above, is meant to provide

protection against all of the major insect pests

of corn. It seems likely that the mammalian

toxicity tests and the test of impact on

non-target animals will be done with the protein

produced in bacteria not the one produced in corn

plants.

In spite of the clear differences between the

genes and the insecticide toxin proteins produced

in bacteria and those produced in transgenic

plants the US and Canadian regulators have agreed

with the corporations manufacturing the GM crops

that the products are substantially equivalent.

So long as the final toxins are similar the

bacterial toxins can be used as surrogates for

the crop toxin in safety testing. The regulators

made little or no effort to directly test the

validity of their presumptions. They are placing

the burden of proof that the toxins in the GM

crops are unsafe for mammals and the environment

on the shoulders of the public, not the

corporations who profit from the GM crops. In the

final analysis, the regulators are providing

essential public relations benefits for the

corporations but not adequately protecting the

public. And so long as GM crops are not labeled

in the market, the errors of the regulators will

go undetected.

1.Romano C. Expression of Cry3B insecticidal

proteins in plants, 2002 US patent 6 501 009

155pp.

2.English L, Brussock S, Malvar, T, Bryson J,

Kulesza C, Walters F, Slatin S, Von Tersch M and

Romano C. Coleopteran-resistant transgenic plants

and methods of their production using modified

Bacillus thuringiensis Cry3Bb nucleic acid. 2003

US patent 6 620 988.

3. US Food and drug Administration Center for

Food safety and Applied Nutrition Office of Food

Additive safety. " Biotechnology consultation note

on the file BNF No. 000075 " ,

2001 <http://vm.cfscan.fda.gov/>http://vm.cfsan.fda.gov/ pp. 1-4

4.US Environmental Protection Agency " Bacillus

thuringiensis Cry3Bb1; Notice of filing a

pesticide petition to establish a tolerance

exemption for a certain pesticide chemical in or

on food " , 2003 Federal Register 68 60371-5

5.US Environmental Protection Agency " Event

MON863 Bacillus thuringiensis Cry3Bb1 Corn " 2003

Biopesticides registration Action Document pp1-34

; C. Environmental Assessment " Biopesticides

registration Action Document pp1-43

6. US Environmental Protection Agency " Bacillus

thuringiensis Cry3Bb1 protein and the genetic

material necessary for its production (Vector

ZMIR13L) in Event MON863 corn fact sheet " 2003.

http://www.epa.gov/oppbppd1/biopesticides/ingredients/factsheets/factsheet_00648\

4.htm

pp1-20

7.Canadian Food Inspection Agency Plant Biosafety

Office, " Decision Document DD2003-43:

Determination of the safety of Monsanto Canada

Inc.’s Insect Resistant Corn (Zea Mays L.) line

MON863 " , 2003

<http://www.inspection.gc.ca/english/plaveg/pbo/dd/dd0343e.shtml>http://www.insp\

ection.gc.ca/english/plaveg/pbo/dd/dd0343e.shtml

pp1-15

8. Herman R, Scherer P,Young D, Mihaliak C, Meade

T, Woodsworth A, Sockhoff B and Narva K Binary

insecticidal protein from Bacillus thuringiensis

, strain PS149B1: Effects of individual proteins

and mixtures in laboratory bioassays. J.Econ.

Entomol 2002, 95, 635-9

9.Ellis R, Stockhoff B, Stamp L, Schnepf H,

Schwab G, Knuth M, Russel J, Cardineau G and

Narva K. Novel Bacillus thuringiensis binary

insecticidal crystal protein active on western

corn root worm. Appl and Environ Microbiol 2002,

68,1137-45.

10. Herman R, Schafer B, Korjagin V and Ernest A.

Rapid digestion of Cry34Ab1 and Cry35Ab1 in

simulated gastric fluid. J.Agric Food Chem 2003,

51,6823-711.

11.US Environmental Protection Agency " Notice for

filing a pesticide petition to establish

tolerance for a certain pesticide chemical in or

on food " 2003 Federal Register 68 11100-3.

12. US Environmental Protection Agency " Bacillus

thuringiensis Cry34Ab1 and Cry 35Ab1 proteins and

genetic material necessary for their production

in corn; Temporary exemption from requirements of

tolerance " 2003 Federal Register 68 40178-83

13. Malvar T and Gilmer A. " Polynucleotide

compositions encoding broad spectrum delta

endotoxins " US patent 6 645 497 pp1-161

This article can be found on the I-SIS website at

<http://www.i-sis.org.uk/full/RSOBTCFull.php>http://www.i-sis.org.uk/full/RSOBTC\

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