MARCH 2007

The Institute of Science in Society

Science Society Sustainability http://www.i-sis.org.uk

ALSO SEE UPDATE, RE. GENE MODIFIED CROPS, END OF THIS PAGE

Science and the Precautionary Principle in UK Government -versus the Regulatory Agencies

Everyone accepts that science and scientific evidence play a major role in deciding whether the precautionary principle should be invoked and applied. Five years ago, the UK government seemed to think so too. Its Interdepartmental Liaison Group on Risk Assessment (ILGRA) produced a report recommending that the precautionary principle should be invoked "when there is good reason to believe that harmful effects may occur to human, animal or plant health or to the
environment; and the level of scientific uncertainty about the consequences or likelihood of the risk is such that the best available scientific advice cannot assess the risk with sufficient confidence to inform decision-making."

In practice, no UK government departments and agencies have made use of the precautionary principle. And this is particularly the case in dealing with genetically modified (GM) food and feed, as documented in the report on p. 32, prepared for the Franco-British Council (FBC) Conference on Risk Management and Government Policy held in Paris in February 2007 (see opposite).

Our report shows how the regulatory agencies (in UK, Europe and USA) ignore the precautionary principle, manipulate scientific evidence, corrupt science and sidestep the law to help promote GM food and feed in the face of damning evidence piling up.

The abuse of science by the regulatory agencies is particularly blatant. Scientific evidence is manipulated by a biased and selective review of the scientific literature and uncritical acceptance of research claiming "no effect", including those submitted by the biotech industry that are flawed at every stage, from experimental design to data collection, analysis, reporting and interpretation. Science is used not only to exclude counter scientific findings, but also to exclude key evidence from the real world where GM crops are grown and farm workers and crop handlers fall ill, and livestock die from the new GM feed. The result is to prevent the precautionary principle from being invoked, let alone applied.

Scientists have been drawn into a tightly closed loop of self-reinforcing "advocacy science" to smooth the passage of GM produce into the market, without regard for safety, or moral, ethical concerns.

At the FBC conference in Paris, it was eerie to hear David Gee, Project Manager of the European Environment Agency (EEA) talk about some of the case histories documented in the excellent EEA Report, Late Lessons from Early Warnings, which covers fisheries, radiation, benzene, asbestos,
polychlorinated biphenyls (PCBs), halocarbons, diethylstilboestrol (DES), antibiotics as growth promoters, sulphur dioxide, chemical contamination in the Great Lakes, tributyltin (TCB) antifoulants, hormones as growth promoters and BSE. GM food/feed looks so much like a replay of these cases in the "misplaced science, and the wrong kind of science" dominating decision-making, with devastating consequences.

ILGRA's report five years ago also stated that when the precautionary principle has been invoked, the burden of proof shifts away from the regulator and it is for the proponents of the activity in question to demonstrate an acceptable level of safety.

Ministers had accepted the report, and a paper issued jointly by the Treasury and the Cabinet Office stated clearly that the government would apply the precautionary principle where there is good reason to believe that irreversible harm may occur and where it is impossible to assess the risk with confidence.

Unfortunately, almost as soon as the ink was dry on the documents that stressed the importance of the precautionary principle, new ones appeared that did not.

The 2005 Treasury document, Managing risks to the public, appraisal guidance, mentioned the precautionary principle, but only as an afterthought. The contrast with the earlier position is so great that Lord Broers, the President of the Royal Academy of Engineering, asked in the House of Lords
why the new document made no reference to the guidance contained in the ILGRA report and whether the government planned to strengthen what it says about the precautionary principle. The answer was no.

In the summer of 2006, the House of Commons Select Committee on Science and Technology produced a report on the use of scientific advice, and in the course of this they came out against the precautionary principle. It is not clear why they object to it, because on the one hand they thought it
was so strong that it would hinder progress, and on the other, they agreed with the government's Chief Scientific Adviser that it says nothing more than that one should be cautious.

In fact, neither criticism is valid. The precautionary principle is a useful tool in risk management but it does not make decisions for us. And while there are different formulations, the basic idea is the same.

What the precautionary principle tells us is that we don't have to wait until we are certain about the hazard before we can take measures to mitigate or avoid it. To act or not depends on the nature of the hazard and the strength of the evidence that we have in front of us. And we have to make sure that the science is not abused to exclude key evidence and to misinform ministers and the public.

At this point, it is still open to the innovator to supply further evidence, and if that is sufficient to reassure us, then the restriction could be lifted. The burden of proof is on the innovator; it is for those who want to change the decision to supply further evidence.

Opponents of the precautionary principle often claim that it will bring a halt to progress and innovation. They forget that while in the criminal courts the burden of proof is on the prosecution, many defendants are convicted. What is required is not proof in the sense of a mathematical
theorem, but proof "beyond reasonable doubt". Every year, thousands of ordinary people serve on juries and are perfectly capable of understanding what this means and reaching verdicts on the basis of the evidence presented to them.

ILGRA is the only UK government body that has looked in detail at the precautionary principle. On the basis of their recommendation, the government accepted that the principle should be part of risk management. That was the right decision, and they should stick with it. And they should start to apply it, too.

Contents
From the Editors
GM-Free
GM-Soya Fed Rats: Stunted, Dead, or Sterile
Global GM Crops Area Exaggerated
GM Wine Sold Unlabelled in the United States
Universal Condemnation Meets UK Government's Green Light for
GM Potato
Rethinking Health
Green Tea, the Elixir of Life?
Green Tea Against Cancers
Climate Change
The Economics of Climate Change
Cloned Food Animals Coming
Is FDA Promoting or Regulating Cloned Meat and Milk?
Cloned BSE-Free Cows, not Safe Nor Proper Science
Science and Government
GM Food Nightmare Unfolding and the Regulatory Sham
Biofuels Not Sustainable
Biofuels, Biodivestation, Hunger & False Carbon Credits
Biofuels Repulbic Brazil
New Physics of Organisms & Its Applications
The Real Bioinformatics Revolution
Proteins and Nucleic Acids Singing to One Another?
Desk Top Drug Discovery
Letters to the Editor
Technology Watch
Yeasts Targeted for High Ethanol Production
GM Grapevines & Toxic Wines



This article can be found on the I-SIS website at
http://www.i-sis.org.uk/AnnouncingSIS33.php

Approval of GM Crops Illegal, US Federal Courts Rule

The courts said it three times so it must be true Prof. Joe Cummins and Dr. Mae-Wan Ho

In a surprising development that may well stump the further approval of GMOs, Federal Courts in the US have ruled against the Department of Agriculture (USDA) in three successive cases for failing to carry out proper environment impact assessment, making the original approvals of GM crops illegal.

It has been twelve years since the world's first GM crop, the Flav Savr tomato, was commercially approved, and hundreds more GM varieties were granted deregulation status. The global area of GM crops has reached 102 million hectares, according to industry sources [1], though this has been strongly contested around the world [2] ( Global GM Crops Area Exaggerated , SiS 33)

The first case was on drug-producing GM crops. A federal district judge in Hawaii ruled in August 2006 that the USDA violated the Endangered Species Act as well as the National Environmental Policy Act in allowing drug-producing GM crops to be cultivated throughout Hawaii, and failing to conduct even preliminary investigations on environmental impact prior to the approval of planting. The plaintiffs were the Center for Food Safety, KAHEA (The Hawaiian Environmental Alliance) , Friends of the Earth, and the Pesticide Action Network, North America. The defendants were the US Secretary of Agriculture and administrators of the USDA.

From 2001 to 2003, four companies, ProdiGene, Monsanto, Hawaii Agriculture Research Center (HARC), and Garst Seed, were allowed to plant corn and sugarcane genetically modified to produce experimental pharmaceutical products such as vaccines, hormones, cancer fighting agents and other proteins that are still under development and hence not yet approved.

The plaintiffs argued that USDA/APHIS broke the law in issuing these permits. Because these crops produce pharmaceutical products that are still at the experimental stage of development, their effect on Hawaii's ecosystem (especially Hawaii's 329 endangered and threatened species) is unknown. The experimental crops could cross-pollinate with existing food crops, and contaminate the food supply. Animals feeding on the crops would also become unwitting carriers of pharmaceutical products, causing even more widespread dissemination of these experimental drugs.

The court concluded that APHIS' issuance of four permits was “arbitrary and capricious” and “an unequivocal violation of a clear congressional mandate” [3].

The second ruling was even more significant. A case was filed in Federal Court Washington DC against the trials of GM creeping bentgrass by the Center for Food Safety, Klamath-Siskiyou Wildlands Center, and other individuals and organizations in 2003. In February 2007, the court gave a decision that broadly affects field trials of all GM crops. Federal district judge Harold Kennedy ruled that the USDA must halt approval of all new field trials until more rigorous environmental reviews are conducted. USDA's past approval of GM herbicide-tolerant creeping bent grass led to widespread dispersal of pollen from the GM grass, and USDA's approval of bent grass trials was ruled illegal [4].

The third decision was on a case filed in Northern California by the Center for Food Safety, environment activists, seed producers and farmers. A Federal Court ruled (February 2007) that Monsanto's Roundup Ready alfalfa had been approved for commercial release illegally, because there had been no Environment Impact Statement. [5]. According to Center for Food Safety, The decision may prevent this season's sales and planting of Monsanto's GM alfalfa and future submissions of other GM crops for commercial deregulation.

Joseph Mendelson, spokesperson for the Center for Food Safety said to a reporter for Science journal [6] that his group may demand an end to sales of GM alfalfa or even a ban on planting GM seed already bought by farmers, while the USDA declined to comment,

Predictably, perhaps, the pro-GM lobby has been toning down the significance of the claims [6], reporting that, “U.S. courts say transgenic crops need tighter scrutiny”.

In all three cases, USDA was found to have flouted the law and disregarded health and environmental concerns in their approvals of the GM crops. The failure to identify the locations and the exact nature of GM crops being tested must also be addressed along with the frivolous use of Confidential Business Information designations to conceal crucial information for safety evaluation and the persistent regulatory bias towards the uncritical acceptance of GM crops.

In the United States, as in Canada, Europe and the UK, a clean sweep of the regulatory regime is long overdue, while a global ban of all further releases of GMOs is in order [7]
( GM Food Nightmare Unfolding and the Regulatory Sham , SiS 33).

References

1. Global Status of Commercialized Biotech/GM Crops: 2006. ISAAA Brief 35-2006: Executive Summary http://www.isaaa.org/Resources/Publications/briefs/35/executivesummary/default.html
2. Burcher S. Global GM crops area exaggerated. Science in Society 33 (to appear).
3. “Court rules federal government acted illegally in permitting field trials of genetically engineered crops in Hawaii.” Press Release Center for Food Safety, 14 August 2006. http://www.centerforfoodsafety.org/Hawaii%20biopharm%20crop%
   20judgement%20Aug%2010,%202006.cfm
4. “Federal court orders for the first time a halt to new field trials of geneticallyengineered crops”, Press Release,Center for Food Safety, 6 February 2007. http://www.centerforfoodsafety.org/GTBC_DecisionPR_2_7_07.cfm
5. “Federal court finds USDA erred in approving genetically engineered alfalfa without full environmental review” Press Release, Center for Food Safety, 8 February 2007. http://www.centerforfoodsafety.org/Alfalfa_DecisionPR2_14_07.cfm
6. “U.S. courts say transgenic crops need tighter scrutiny”, Dan Charles, News the Week, Science 2007, 315, 1069.
7. Ho MW. GM food nightmare unfolding and the regulatory sham. Science in Society 33 (to appear)

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