Genetic Engineering Produces A Genuine Monstrosity

By Henry I. Miller and Drew L. Kershen

Activists have warned for decades that genetic engineering would create some sort of monstrosity like Dr. Frankenstein’s creature.  It turns out they were right: Government regulation has run amok and threatens advances in agriculture. USDA’s existing regulatory policy harms researchers, farmers and consumers alike, but there is little interest in taking up sticks and pitchforks (metaphorically speaking) to resist the bureaucrats.

USDA’s unscientific, overly complex regulation of genetically engineered crops is a historical fluke — an anomaly that originated more than a quarter century ago.  In 1986 the White House Office of Science and Technology Policy published a policy statement on the regulation of biotechnology that focused oversight and regulatory triggers on the risk-related characteristics of products, such as plants’ weediness or toxicity.  OSTP specifically rejected regulation based on the particular process used for genetic modification.  (Genetic modification had been performed by a continuum of techniques for centuries.)

In 1992, in a second policy statement the federal government reaffirmed the overarching principle for biotechnology regulation: The degree and intrusiveness of oversight “should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique.”  Thus, dating from the 1980′s, there has been a broad consensus in the scientific community (which has been reflected in statements of federal government policy) that the newest techniques of genetic modification are essentially an extension, or refinement, of older, less precise and less predictable ones, and that oversight should focus on the characteristics of products, not on process.

However, intent on building a regulatory empire, USDA heeded neither the consensus of the scientific community nor the directives from the White House.  The resulting unscientific, stultifying regulation has inhibited research and development, particularly in public institutions, ever since, and has provided an endless source of all manner of mischief, including superfluous, obstructive government bureaucracies; wasteful spending on poorly-conceived risk-assessment research; vandalism of field trials; bad-faith legal harassment; and endless nattering by the ill-informed and the ideological.

A manifestation of the mischief spawned by flawed regulation is USDA’s recent decision to perform unnecessary, expensive, time-consuming Environmental Impact Statements (EISs) on two applications for crops genetically engineered to be resistant to 2,4-D and dicamba, herbicides that have been safely and widely used in the U.S. since the 1960′s.

In what way is USDA’s biotechnology regulation mischievous?  USDA’s Animal and Plant Health Inspection Service (APHIS) had long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are “plant pests,” defined by means of an inclusive list – essentially a “thumbs up or thumbs down” approach.  A plant that an investigator might wish to introduce into the field is either on the inclusive, prohibited list of plants pests — and therefore requires a permit — or it’s exempt.

This straightforward approach is risk-based, in that the organisms required to undergo case-by-case governmental review are an enhanced-risk group — organisms that can injure or damage plants — compared to organisms not considered to be plant pests.  But for a quarter century, this risk-based USDA regulation has had a kind of evil twin — a regime focused exclusively on plants altered or produced with the most precise genetic engineering techniques.  USDA tortured the original concept of a plant pest as something known to be harmful and crafted a new, jury-rigged category: a “regulated article,” defined in a way that captures virtually every genetically engineered plant for case by-case review, regardless of its potential risk.

In order to perform a field trial with a regulated article, a researcher must apply to USDA and submit extensive paperwork before, during and after the field trial.  After conducting field trials for a number of years at many sites, the developer then submits a vast dossier of data and requests “deregulation” by USDA, which is equivalent to approval for unconditional release.  These requirements make genetically engineered plants extraordinarily expensive to develop and test – which is the reason that up to now, commercialization has been limited primarily to huge-scale commodity crops.

USDA’s discriminatory treatment of genetically engineered plants — most of which have been modified for enhanced pest-, disease-, or herbicide-resistance — makes no sense.  Plants have long been selected by nature and bred by humans or irradiated to create mutants with enhanced resistance or tolerance to external threats – insects, disease organisms, herbicides and environmental stresses – to their survival and productivity.  Plants have also been modified by farmers and plant breeders for other qualities, such as yield and attractiveness to consumers.  Corn has undergone gradual but drastic modification that has seen it evolve from the original grass-like plant, teosinte, with primitive, meager kernels into modern varieties with regularly arranged kernels bulging with carbohydrates, oils, and protein.  Primitive wheat breeders crafted durum (hard) wheat for pasta and softer varieties for cakes, often by crossing wheat varieties with remotely related species of wild grasses.

Plant breeders have learned from experience about the need for risk analysis, assessment and management.  New varieties of plants (whatever the technique used to craft them) that normally harbor relatively high levels of toxins — such as celery, squash and potatoes — are analyzed carefully to make sure that levels of potentially harmful substances remain in the safe range.

The degree of regulatory oversight should be proportionate to the perceived risk of the genetically engineered plant, which is a function of certain characteristics of the host plant (weediness, toxicity, ability to outcross, etc.) and the introduced gene. What is important is not the source of the new genetic material or the method used to introduce a gene; it is its function.  But for a quarter century, plants made with the newest, most precise techniques have been subjected to the most regulation, independent of risk.

Moreover, the fact that USDA’s regulatory policy makes “deregulation” a “major action” triggers certain required assessments under the National Environmental Policy Act, which has provided an opportunity for activists to enlist the courts in obstructing the deregulation of various genetically engineered plant varieties.

There are no outstanding, unresolved issues of environmental or human safety concerning the crops (corn and soybeans) resistant to 2,4-D and dicamba for which EISs will be performed.  There is no need for USDA to perform EISs prior to their “deregulation” (that is, approval for unlimited, unconditional release).  After Dow AgroSciences and Monsanto filed a petition to deregulate their 2,4-D- and dicamba-resistant crops, respectively, several years ago, USDA’s Animal and Plant Health Inspection Service (APHIS) initiated the process required by the Plant Protection Act to determine whether these seeds and plants could be plant pests.  APHIS should complete that determination; and if these seeds and plants are not plant pests (as seems self-evident), APHIS should deregulate without further delay, in accordance with a recent Ninth Circuit Court of Appeals decision, Center for Food Safety v. Vilsack, which held that once APHIS has determined that a genetically engineered agricultural commodity is not a “plant pest,” the agency lacks jurisdiction to consult further under the Endangered Species Act (ESA) or to conduct an EIS.  The wording of the decision is definitive: “[O]nce APHIS concluded that [the genetically engineered plant] was not a plant pest because it did not cause plant pest injury to plants, the agency had no jurisdiction to continue regulating the crop. The agency’s deregulation of [the plant] was thus a non-discretionary act that did not trigger the agency’s duty to consult under the ESA.”

That ruling of the Ninth Circuit makes NEPA and ESA relevant only when APHIS determines that a genetically engineered agricultural commodity is a “plant pest” under the Plant Protection Act.

In the published announcements that EISs would be undertaken for the evaluation of the crops resistant to 2,4-D and dicamba, APHIS indicated that the decision was driven by concerns about weed resistance related to herbicide usage.  However, EPA — not USDA — has the authority to regulate herbicides (under FIFRA, the Federal Insecticide, Fungicide and Rodenticide Act), taking into account the environmental impact of weed resistance issues. EPA had already exercised its authority under FIFRA in authorizing dicamba and 2,4-D as herbicides – and EPA’s environmental reviews under FIFRA are considered to be “functionally equivalent” to an EIS under NEPA.  Therefore, given that EPA had performed the functional equivalent of an EIS, APHIS is limited to determining plant pest status but lacks the statutory authority to consider weed resistance.  APHIS’ NEPA obligations can be fulfilled with a simple Environmental Assessment (EA) that relies upon EPA’s herbicide approvals under FIFRA.

The performance of unnecessary EISs is a huge waste of government officials’ time, labor and resources.  The delay in deregulation harms farmers, who need improved corn and soybean varieties for easier weed-control; unduly burdens industry; and creates a disincentive to innovative R&D.

The fundamental problem with USDA’s regulation of genetically engineered plants lies not at the end of the process – that is, the determination whether an EA suffices or an EIS is required; rather it resides in what comes under regulators’ purview in the first place. What we need is a more rational approach to the scope of the new plant varieties that are subject to governmental review – an approach that is based on the risk-related characteristics of plants and conforms to announcements of policy published by OSTP in 1986 and 1992.  Until then, plant genetic engineering will fail to realize anything approaching its full potential. (FORBES)

Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA.  Drew L. Kershen is the Earl Sneed Centennial Professor of Law (Emeritus), University of Oklahoma College of Law, in Norman, Okla. 

The GMO Debate

Monroe cardiologist questions safety of genetically engineered foods

Dr. Gregory Sampognaro, a Monroe cardiologist, said he was shocked to learn just how much of the food most Americans consume has been genetically modified.

Sampognaro first began educating himself on foods termed GMO— derived from genetically modified organisms, which have had specific changes made to their DNA by genetic engineering techniques to enhance certain traits — about three months ago."The more I learned, the more concerned I became about the health of my patients, as well as the health of my children,” he said. “Once you start educating yourself, it really starts bringing up a lot of questions about whether this is something that’s good for us.”The Center for Food Safety, a national non-profit public interest and environmental advocacy organization, estimates that more than 75 percent of processed foods on supermarket shelves contain genetically modified ingredients. The U.S. does not require labels on the view that genetically modified food is not materially different than non-modified food, although the issue is being debated by activists around the country.Europe largely bans genetically engineered foods and has strict requirements on labeling them.The most common genetically modified foods are corn, soybeans, canola, cotton and rapeseed oil. Genetic modification is used to help plants resist disease and drought, ward off insects and boost the food supply.Sampognaro‘s concern is whether these genetically engineered foods pose significant health risks for humans, which is why he promotes eating an organic and heart-healthy diet to his patients.“There have been no studies, short or long-term, in human beings to determine whether there are any health risks at all in genetically modified foods,” he said. “Any drug that I prescribe as a physician has to go through strict Food and Drug Administration protocol where those drugs can be determined safe or not to give to patients.“But in the U.S. we’re feeding genetically modified foods like crazy to our people with the majority of people not even knowing they’re consuming it and having no clue what the health impact will be much controversy has surrounded the topic of genetically modified food safety in the U.S. for years, and research remains inconclusive, according to Dinesh Babu, assistant professor of food safety and toxicology at the University of Louisiana at Monroe’s College of Pharmacy.“There are so many studies out there about genetically modified foods. Some claim it’s dangerous, and some claim it’s not harmful,” he said.Babu said more research is needed to determine the long-term health effects of genetically modified foods in humans. But that doesn’t mean people should assume the worst, he said.“There’s no need to be alarming the public about it. These kinds of foods have been in the market for decades,” he said.The FDA generally recognizes these foods as safe, and the World Health Organization has said no ill health effects have resulted on the international market.Opponents worry that people who eat genetically modified foods may be more prone to allergies or diseases resistant to antibiotics. But they have been hard pressed to show scientific studies to back up those fears.Sampognaro suggested people get informed on the subject and make their own decision.He believes genetically modified foods could play a role in the national increases in obesity, heart disease, cancer and diabetes rates.“All of this has sort of been a new epidemic over the last 15 to 20 years and you assume it has to be something in the environment that’s causing all of this, and one big thing that has occurred over the last 15 years that is new is the genetically modified foods,” he said. “I think everyone should educate themselves and make the decision whether they want to consume this food or not, and once they make that decision, they need to go to the grocery store or local restaurant and start demanding they carry more organic USDA certified foods.” The Associated Press contributed to this report. (The NewsStar)

http://www.newsok.com/article/3872085

Has that Oklahoma waving wheat been modified?

Oklahoma scientists consider pros, cons of genetically modified wheat.

Science labs, mice, radiation, chemicals, test tubes and ... wheat?

That's an image commonly associated with the words “genetically modified wheat” and it can cause consumer watch activists to rally in Washington, shoppers to scan food labels and wheat producers to try to assure buyers their crops are safe.

Student Ming Yu works to genetically modify wheat at a laboratory at the Noble Research Center on the campus of Oklahoma State University in Stillwater. PHOTO BY PAUL HELLSTERN, THE OKLAHOMAN PAUL HELLSTERN - Oklahoman

“For all the fear that's associated with genetically modified wheat the reality is that there is no finding that it's any different than regular wheat,” said Brett Carver, professor of wheat breeding and genetics at Oklahoma State University.

Genetically modified wheat is engineered by the direct manipulation of its genome, the area of an organism that holds its hereditary information encoded by DNA.

The goal, Carver said, is to create wheat that is more tolerant of drought, heat and pesticides. Wheat can also be modified to utilize fertilizer and nitrogen more efficiently, resist disease or increase fiber and mineral content.

All of which, Carver said, could result in a higher yield.

Carver and a team of microbiologists genetically modify wheat at OSU's Noble Research Center in a highly controlled setting. The lab is one of thousands where the effects of genetically modifying wheat are studied.

The commercialization of genetically modified wheat has not been approved by the Food and Drug Administration. For now, the wheat is confined to field trials and laboratories.

But the prospect of growing more wheat on the same amount of land is promising for a growing global population. Agriculture production will need to increase by an estimated 60 percent globally and 77 percent in developing countries by 2050 to keep pace with population growth, according to the United Nations Food and Agriculture Organization.

“Wheat is essential to the global diet, representing 20 percent of the calories consumed by people around the world. But a number of serious issues, including more people and less farmland, threaten its supply,” said Steve Mercer, vice president of communications for U.S. Wheat Associates.

In Oklahoma, about 5.2 million acres of hard red winter wheat are planted every year, said Mike Schulte, executive director of the Oklahoma Wheat Commission. Wheat is the state's largest cash crop, producing about $1 billion dollars annually. Oklahoma exports about half the wheat grown in the state with the rest used locally, Schulte said.

“I don't think biotechnology is the only solution to feeding the increasing population but it's worth looking into,” Schulte said.

With Oklahoma often ranking in the top five wheat-producing states, genetically modifying the grain to produce higher yields could theoretically benefit the state's economy, Schulte said.

“Our economy could be strengthened but only if genetically modified wheat is accepted into the world marketplace,” Schulte said. “There are some misconceptions out there that we have genetically modified wheat in the market right now and that's simply not true. Doing so would harm our economy.”

A glimpse of the backlash that could result from introducing genetically modified wheat into the global market before U.S. trade partners have agreed to accept it happened after an Oregon farmer found genetically modified wheat on his farm. NEWSOK

GMOs and the Destruction of Indian Agriculture

GMOs and the Destruction of Indian Agriculture: Government in Collusion with the Biotech Conglomerates

Released in late July, the final report of India’s Supreme Court-appointed Technical Expert Committee (TEC) on field trials of genetically modified crops reveals all of what is wrong with governance and regulation in India when it comes to GMOs (genetically-modified organisms). So says Aruna Rodrigues, lead petitioner in the Supreme Court for a moratorium on GMOs. 

This report is the fourth official report which exposes the lack of integrity, independence and scientific expertise in assessing GMO risk.

The TEC recommends that there should be an indefinite stoppage of all open field trials of GM crops, conditional on systemic corrections, including comprehensive and rigorous risk assessment protocols. The report includes a specific focus on Bt food crops. It also calls for a ban on the environmental release of any GMO where India is the centre of origin or diversity. It also says herbicide tolerant (HT) crops, targeted for introduction by the regulator, should not be open field-tested. The TEC  “finds them completely unsuitable in the Indian context as HT crops are likely to exert a highly adverse impact over time on sustainable agriculture, rural livelihoods, and environment.”

Writing in The Hindu on 12 August, Rodrigues states:

“Sound science and factual data form the basis of the TEC decisions. There is practical and ethical sense too. The TEC insists that the government bring in independence, scientific expertise, transparency, rigour and participative democracy into GMO regulation and policy. The accent is on bio-safety.”

She goes on to discuss some of the dangers involved in exposing huge populations to the risks associated with GMO. It is simply not good enough to treat people as human guinea pigs, without their knowledge or consent:

“GMOs produce “unintended effects” that are not immediately apparent and may take years to detect. This is a laboratory-based, potent technology, described by WHO as “unnatural.” The risk assessment (RA) protocols for GMOs are an evolving process to be performed by qualified and experienced experts who must be responsive to the latest scientific knowledge. The fact is that GMOs involve us in a big experiment in the idea that human agencies can perform adequate risk assessment, which, it is expected, will deliver safety at every level/dimension of their impact on us — the environment, farming systems, preservation of biodiversity, human and animal safety.”

As to the efficacy of GMOs, evidence is mounting that they are bad for health, bad for the environment, bad for agriculture and bad for food security:

“After 20 years since the first GM crop was commercialised in theU.S., there is increasing evidence, not less, of the health and environment risks from these crops. Furthermore, we now have 20 years of crop statistics from the U.S., of two kinds of crops that currently make up over 95 per cent of all GM crops cultivated globally, (like Bt cotton) Bt and HT crops. The statistics demonstrate declining yields. GM yields are significantly lower than yields from non-GM crops. Pesticide use, the great “industry” claim on these GM crops, instead of coming down, has gone up exponentially. In India, notwithstanding the hype of the industry, the regulators and the Ministry of Agriculture (MoA), Bt cotton yield is levelling off to levels barely higher than they were before the introduction of Bt.”

Rodrigues also wants to know where is the advantage and why are we experimenting given all the attendant risks? We have hard evidence from every U.N. study and particularly the World Bank-funded International Assessment of Agricultural Knowledge and Science for Development Report, which India signed in 2008.

“The IAASTD was the work of over 400 scientists and took four years to complete. It was twice peer reviewed. The report states we must look to small-holder, traditional farming to deliver food security in third world countries through agri-ecological systems which are sustainable. Governments must invest in these systems. This is the clear evidence.”

Unsurprisingly, the response to the TEC Final Report came immediately from the Ministry of Agriculture, which strongly opposed the report. This, according to Rodrigues, was to be expected given the conflict of interests:

“The Indian Council of Agriculture Research (ICAR) promotes PPPs (Public-Private-Partnerships) with the biotechnology industry. It does this with the active backing of the Ministry of Science and Technology. The MoA has handed Monsanto and the industry access to our agri-research public institutions placing them in a position to seriously influence agri-policy inIndia. You cannot have a conflict of interest larger or more alarming than this one. Today, Monsanto decides which Bt cotton hybrids are planted — and where. Monsanto owns over 90 per cent of planted cotton seed, all of it Bt cotton.”

All the other staggering scams rocking the nation do have the possibility of recovery and reversal, but, as Rodrugues argues, the GM scam will be of a scale hitherto unknown:

“It will also not be reversible because environmental contamination over time will be indelible. We have had the National Academies of Science give a clean chit of biosafety to GM crops — doing that by using paragraphs lifted wholesale from the industry’s own literature! Likewise, Ministers in the PMO who know nothing about the risks of GMOs have similarly sung the virtues of Bt Brinjal and its safety to an erstwhile Minister of Health. They have used, literally, “cut & paste” evidence from the biotech lobby’s “puff” material. Are these officials then, “un-caged corporate parrots?”

Rodrigues argues that Ministries, least of all “promoting” Ministries, should not have the authority to allow the novel technology of GMOs into Indian agriculture bypassing authentic democratic processes.  Such processes require the widest possible — and transparent — consultation across India, not least because it is an entire nation that will quite literally have to eat the outcome of a GM policy that delivers up Indian agriculture to it. Global Research