Fbae Logo
Home | | Support Us | Contact Us
Goals & Objectives Our Position False Propaganda Special Topics Important Publications Important Links Events news Biosafety
Fbae Header Home




Commentary: EPA's Slimy Regulation

Henry I. Miller

Members of the California State Assembly's no-amount-of-regulation-is-ever-enough Democratic caucus recently announced forthcoming legislation to address oil spills. The initiative was precipitated by the November 2007 oil spill in San Francisco Bay by the container ship Cosco Busan.

What we really need is not just more, but more intelligent regulation. However, the federal government has made that difficult.

Accidents that cause oil spills are inevitable as long as they can be caused by human or mechanical failures or the vagaries of weather. One factor that should be controllable is the government's creation of disincentives to developing gene-spliced micro-organisms that could degrade spilled oil. But Draconian federal regulations ensure that the techniques available for responding to these disasters remain low-tech and marginally effective. They include methods such as deploying booms to contain the oil, spraying chemicals to disperse it, and spreading absorbent mats.

At the time of the catastrophic 1989 Exxon Valdez spill in Alaska, there were great expectations for modern biotechnology applied to "bioremediation," the biological cleanup of toxic wastes, including oil. William Reilly, then head of the U.S. Environmental Protection Agency, later recalled, "When I saw the full scale of the disaster in Prince William Sound in Alaska ... my first thought was: Where are the exotic new technologies, the products of genetic engineering, that can help us clean this up?"

He should know. Innovation had been stymied by Mr. Reilly's own agency's hostile policies toward the most sophisticated new genetic engineering techniques. In 1997, EPA issued the regulation in final form, ensuring that biotech researchers in several industrial sectors, including bio-cleanup, will continue to be intimidated and inhibited by regulatory barriers.

The EPA regulation focuses on any "new" organism (strangely and unscientifically defined as one that contains combinations of DNA from unrelated sources) that might, for example, literally eat up oil spills. For EPA, "newness" is synonymous with risk. And because gene-splicing techniques can easily be used to create new gene combinations with DNA from disparate sources, these techniques therefore "have the greatest potential to pose risks to people or the environment," according to the agency press release that accompanied the rule. (That's like arguing that newer, more comfortable automobiles with additional safety appurtenances are actually more dangerous, because people are likely to drive them longer distances.)

But science says otherwise. The genetic technique employed is irrelevant to risk, as is the origin of a snippet of DNA that may be moved from one organism to another: what matters is its function.

Scientific principles and common sense dictate which questions are central to risk analysis for any new organism. How hazardous is the organism you started with? Is it a harmless, ubiquitous organism found in garden soil, or one that causes illness in humans or animals? Does the genetic change merely make the organism able to degrade oil more efficiently, or does it have other effects, such as making it more resistant to antibiotics and therefore difficult to control?

EPA's subjecting new biotechnology to extraordinary regulatory requirements is incompatible with longstanding, widely held scientific consensus that holds gene-splicing technology is essentially an extension, or refinement, of earlier, cruder techniques of genetic modification. We should regulate on the basis of the traits of organisms, not because they contain DNA from different sources.

The evidence against EPA's reasoning and the agency's negative policies toward testing new biotech products is overwhelming. The U.S. National Academy of Sciences has said there is no evidence that novel hazards are produced by gene-splicing or the movement of genes between unrelated organisms. The U.S. National Research Council has observed that use of the newest biotechnology techniques actually lowers the already minimal risk associated with field testing. The reason is that the new technology makes it possible to introduce pieces of DNA that contain one or a few well-characterized genes, in contrast with older genetic techniques that transfer or modify a variable number of genes haphazardly. All this means that users of the new techniques can be more certain about the traits they introduce into the organisms.

EPA's regulation requires costly case-by-case government review of virtually all field trials of gene-spliced micro-organisms. "Naturally occurring" organisms are exempt from this process, however, even if they might foul waterways or pose other serious environmental or public health risks. Moreover, the EPA continues to exempt from review all small-scale field trials of chemicals, including those similar to pesticides and the poison gas sarin.

While EPA's exempt-everything-except-gene-splicing approach can hardly be said to be risk-based, it does manifest a certain logic based on scale: small-scale experiments seldom pose significant safety concerns. Under the EPA's traditional exemption for small-scale trials, R&D has been performed safely for more than a century with thousands of strains of micro-organisms (many of them genetically engineered with older, less precise techniques) for purposes as varied as pest control, frost prevention, artificial snow-making, promoting the growth of plants, mining, oil recovery, cleanup of toxic wastes and sewage treatment.

The bottom line is that organisms crafted with the newest, most sophisticated and precise genetic techniques are subject to discriminatory, extraordinary regulation. Research proposals for field trials must be reviewed case by case, and companies face uncertainty about final commercial approvals of products down the road even if they should prove safe and effective.

Government policymakers seem oblivious to the power of regulatory roadblocks. The expense and uncertainty of performing R&D with gene-spliced organisms have virtually eliminated the new biotechnology from bioremediation. Companies know that experiments using the new biotechnology will meet a wall of red tape and politics, and require vast expense.

Unscientific and regressive regulatory policies have already left a legacy of environmental damage and reliance on inferior methods for the cleanup of wastes. These policies are yet another example of the contempt in which federal environmental regulators hold science, technology and the public interest.

Henry I. Miller is a physician and molecular biologist and a fellow at Stanford University's Hoover Institution. His most recent book is "The Frankenfood Myth."
Related News Articles

Bt-corn does not harm biodiversity

Countering insect resistance with designer Bt toxins

ICGEB receives grant from the Bill & Melinda Gates Foundation to strengthen and expand biosafety systems in sub-Saharan Africa

Policy on the transfer of Genetically Improved Farmed Tilapia (GIFT) from Asia to Africa by the WorldFish Center

Rules on marketing GM produce face review

EU ministers to debate Bayer's GM cotton, soybeans

EU's legal labyrinth of GMO legislation


The latest issue of Plant Physiology (July 2008; Volume 147, Issue 3) has a special section on next generation of biotech crops especially on nutritional improvement.  These papers can
be downloaded free!

Influence of Transgenosis on the Plant-Insect- Relationships, in Particular on Chemically       Mediated Interactions

Effect of Transgenes Conferring Enhanced Pathogen Resistance on the Interaction with Symbiotic        Fungi in Rice

Impact on the Soil Ecosystem through Natural and Genetically Engineered Organisms:
      Effects, Methods and Definition of Damage as Contribution to Risk Assessment

The Decomposition of Bt-Corn on the Fields and its Impact on Earthworms and on other        Macroorganisms in the Soil

Environmental Post-market Monitoring of Bt-maize:
       Approaches to Detect Potential Effects on Butterflies and Natural Enemies

Columns by Dan Gardner

Against the Grains: 'The Terminator Hoax '

Decisions taken in the 84th Meeting of the Genetic Engineering Approval Committee

Brazilian Health Biotech: Fostering Crosstalk Between Public and Private Sectors

Biotechnology Related Article Appeared on 'Samyukta Karnataka' ( Regional Language )
June 12, 2008.

Nothing Left to the Imagination

The Politics of GM Food
Kirit S Javali

Hi-tech seed factories: Sowing Seeds of Success

"Indian Seed Industry is Well Placed to Serve Both Domestic and International Markets"
Dr MK Sharma,
Managing Director,
Mahyco Monsanto

"If we Facilitate Seed Industry, we Facilitate Growth in Agriculture"
Dr Govind Garg,
Krishidhan Seeds

Metagenomics: Window to the Microbial Universe

Few Checks to Prevent Entry of GM Food

Gene Campaign Criticises India’s ‘Silence’ at Global Bio-Safety Meet

An Enforceable International Compact for Infectious Diseases

"Indian Science in Genomics has been Able to Place Itself on the Global Map"

Indian Gene Decoded

The Development of RNAi as a Therapeutic Strategy

FAO E-Conference on Biotechnologies and Water Scarcity

Genetic Landscape

Biotechnology in Food and Agriculture

RH Nature Reviews Genetics 08- Opposition to Transgenic Technologies

Germany: Discussion Paper of German Ag-Industry about EU Biotech Policy Implications

Bt maize performance in Spain

Arsenic speciation varies with type of rice

Why I Am Bothered by Neo-Colonialist NGOs

China experts identify gene for yield, height in rice

The French government has called for a debate on the review of the EU
The World Trade Organisation (WTO) has also repeatedly criticised the EU for "undue delays" in the authorisation of GMOs. See the latest WTO ruling:

The legal bans are in France, Austria, Poland, Hungary and Greece.

EU delays decision on approving more GM crops

UCR Geneticist Plays Scientific Advisor to Movie about “Love, Adventure and ... Genetically Modified Rice”

Gujrat worst-hit by illegal Bt cotton production

Farmers seek ban on GM crops

Call for policing
Ijaz Ahmed Rao discusses the virtues of a bio-safety framework for genetically modified crops, now that they have become farmers’ favourite

Stem cells: The 3-billion-dollar question

Genes as the solution

Food crisis spurs research spending

Global Food Crisis / UN / Bilingual Transcript of Statements by Secretary-General, Heads of Concerned Agencies, and Response to Questions at Press Conference on Global Food CrisisGM Crops, A World View

Mass Protests against GM Crops in IndiaInterference at the EPA

Open letter to Robert B. Zoellick, President, World BankNew BT variety may push short staple cotton output.

The future of agricultural biotechnology: Creative, destruction, adoption, or irrelevance? ICABR Conference 2008

Soaring food prices and global grain shortages are bringing new pressures on governments, food companies and consumers to relax their longstanding resistance to genetically engineered crops.

Prof. Kameswara Rao and Dr. T.M. Manjunath's Participation in 2008 Biotech Activities

Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest

LEADER: Nurturing nanotech

Center for Indigenous Knowledge for Agriculture and Rural Development

Scientists find potential schistosomiasis treatment

Islamic conference boosts S&T with new resolutions

Mexico publishes GM approval guidelines

Uganda 'close to stamping out Hib meningitis'

New method 'prevents spread of GM plants'

Social factors 'help women with post-tsunami stress'

Women scientists celebrated in new charter

Sub-Saharan Africa news in brief: 13–25 March

Brazil creates US$18 million fund for young scientists

Health weeks 'powerful tools' for deworming children

Rotavirus vaccine, not treatment, 'cheaper for Panama'