Nano & Biotech

Earlier today, Reps. Mike Pompeo (R-Kan.) and G.K. Butterfield (D-N.C.) introduced a bill in the House that would establish federal standards for the labeling of genetically engineered (GE) foods and preempt a growing patchwork quilt of state action on GE labeling. The underlying motivation behind the “Safe and Accurate Food Labeling Act of 2014” (H.R. 4432) is praiseworthy, so the congressmen deserve an A for effort. However, the execution leaves more than a little to be desired.

This year, an estimated 25, or more, states will consider legislation or ballot initiatives that would mandate special labeling for many GE foods. As I’ve written before, those proposals are bad policy, make no sense scientifically, would needlessly raise the cost of producing and selling safe, nutritious and wholesome food, and are arguably unconstitutional on several grounds. Nor would they give consumers any actual knowledge about what’s “in their food” – the ostensible purpose of those state measures.

The U.S. Food and Drug Administration’s current policy requires foods to be labeled when a material difference has been made in their composition – and the labels must say what the actual change is, not simply what technique was used to make the change. So, in many ways, the FDA’s current policy does a far better job of telling consumers what’s in their food than a GE labeling mandate ever could.

By explicitly preempting state labeling laws and making clear that FDA policy on GE food labeling is the law of the land, H.R. 4432 would serve an extremely valuable function. And, because the packaged food items found in most grocery stores are the epitome of interstate commerce, ensuring that oversight of their safety and labeling be governed at the national level, rather than state-by-state, perfectly reflects the plan established by the framers of the U.S. Constitution.

Unfortunately, in order to attract support for this perfectly reasonable preemption measure, H.R. 4432 offers GE skeptics the enticement of increasing the FDA’s regulatory power. The proposal would grant FDA the authority to keep all new GE foods off the market until agency heads and the presidential administration they work for feel politically safe to grant approvals. Like most other “gatekeeper” regulatory agencies, the FDA would not even need to reject approval for products they don’t like. They would need only decline to make an approval or disapproval determination indefinitely.

Supporters point to a 180-day statutory deadline in the bill, which they argue will force the FDA to make timely approval decisions. But it’s worth noting that the FDA faces identical 180-day statutory deadlines for making approval/disapproval decisions on a host of other products, ranging from new pharmaceuticals and medical devices, to new veterinary drugs and new GE food animals. The agency disregards those deadlines on a routine basis because there is no triggering mechanism that automatically grants a producer the right to put safe and effective products on the market when a recalcitrant FDA refuses to act.

Want to know just how effective that 180-day deadline is? Just ask AquaBounty, the developers of a GE salmon that would help fish farmers deliver one of America’s favorite seafoods to market in a less expensive and more environmentally sustainable way. The FDA determined several years ago that the AquaBounty salmon was safe for consumers and the environment, but its approval has been held up by the Obama Administration simply because their supporters in the environmental movement object to the technology.

Reps. Pompeo and Butterfield do deserve credit for trying to resolve the growing problem of confusing, expensive, and scientifically meritless state labeling proposals for GE food. But, the “Safe and Accurate Food Labeling Act of 2014” contains a serious flaw that will hopefully be corrected once the bill moves to committee.

Have a listen here.

The Food and Drug Administration recently banned 23andMe, a genetic testing service, from marketing its product to consumers. CEI Executive Director and Senior Fellow Gregory Conko thinks the FDA should reverse the ban.

The debate over whether or not to label products of genetically modified (GM) crops has seen a small revival after the Natural Products Association, a trade group representing over 2,000 companies, announced its backing of legislation requiring labeling of GM food products.

In 2012, more hectares of GM crops were planted in the developing world than the developed for the first time. From ISAAA.

In 2012, more hectares of GM crops were planted in the developing world than the developed for the first time. From ISAAA.

Further, the state of Washington will put Initiative 522 on its ballot on November 5, sparking a battle much like the one over California’s Proposition 37 last year, which was narrowly defeated on Election Day.

On July 17, British environmental advocate and journalist Mark Lynas spoke at the Center for Strategic and International Studies  in Washington, D.C., on his “changed perspective on GMO Food.” In January of this year, Lynas vocally renounced his long-held opposition to GMOs, saying that since his initial opposition to GMOs began in the 1990s, he “discovered science.”

While there are volumes of research extolling the virtues of GMOs in helping to achieve many goals concurrent with those of environmentalists, from maintaining biodiversity to reducing pesticide use, many continue to decry their use based on passionate irrationality alone. This science that Lynas and many others are beginning to “discover” is lending increased sanity to the GM debate, but anti-GMO advocates are still able to evoke visceral reactions from the public by holding up their signs depicting Frankenfish, corn with hooves, or self-aware rice.

The approval process of GM products is already long, costly and uncertain, discouraging private investment in agricultural technologies. Lynas used Europe as a cautionary tale, saying its “food sector is turning into a museum,” because of its tenacious distaste for all things genetically modified (it allows but two type of GM crops to be planted, if special permission is granted). The labeling proposals would add more unnecessary costs for producers, costs that would undoubtedly be in part passed on to consumers in the form of higher prices.

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In April, President Obama  announced a new BRAIN Initiative. Its stated goal is to “give scientists the tools they need to get a dynamic picture of the brain.” After a multitude of recent failed trials for Alzheimer’s drugs, it’s become increasingly apparent there is a need for a more basic understanding of the way the brain operates. As big pharma continues to funnel money into later-stage trials in hopes of blindly stumbling upon a potential blockbuster drug, the BRAIN Initiative aims to give researchers a better working understanding of the brain so development money can be more efficiently directed to potential cures.

As federal funding for basic research continues to dry up, patent grants and overall funding for the most basic of scientific research continues to reach record highs.

As federal funding for basic research continues to dry up, patent grants and overall funding for the most basic of scientific research continues to reach record highs.

Even the BRAIN Initiative is only partially funded by the government though. President Obama pledged $100 million in seed money, and a group of non-profit institutions like the Howard Hughes Medical Institute (HHMI) have already promised to more than match that.

Research has suggested that HHMI scientists have produced high-impact work at a much higher rate than NIH-funded scientists. Science is not just about maintaining a status quo; it takes agility and audacity to adapt to the current landscape. HHMI is known for tolerating failure, giving its researchers more freedom, and rewarding long-term success. Meanwhile, NIH grants are subject to reviews on a much more regular basis.

While this suggests an initiative as bold as Obama’s BRAIN child may be better off as a privately funded venture, if government is going to take on such a heady project, it should take a lesson from HHMI’s model. Government can more efficiently allocate funds by giving scientists free reign in where the money is actually directed. Instead of Washington bureaucrats directing money towards some predetermined (and often political) goal, it should be a scientist making decisions, for the good of discovery.

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Innovation- it’s the buzzword of the day. From President Obama’s State of the Union address to Foreign Policy’s latest cover story to initiatives to revive Middle America, the word has been invoked to solve problems from Africa to St. Louis. It’s a seductive notion: if we just innovate, discovering new technologies, drugs, and agricultural products, the global economy can be driven out of the stagnation it’s experienced since the Great Recession. Even the great Robert Solow realized that technological process was the primary driver of long-run economic growth.

But, innovation largely remains a goal without a clear path towards attaining it. Should research and development be funded primarily by the private or public sector? Should the government direct its increasingly limited funds more towards basic research or towards developing products for commercialization?

As sequestration and concern over rising budget deficits continue to slice into discretionary spending, including in the sciences, new techniques for funding innovative discoveries in the biosciences and beyond will need to be utilized.

from the Washington Post. Sequestration cuts have sliced into government's R&D spending, creating a gap for the private sector to fill.

From The Washington Post. Sequestration cuts have sliced into government’s R&D spending, creating a gap for the private sector to fill.

This means the private sector will have to step up its investment in risky, basic research. Venture capital has dried up in the last five years, and large corporations have only filled a portion of the gap. Some have proposed novel securitization techniques to minimize risk and attract large investors like pension funds. Others have proposed a sort of non-profit organization for useful innovations in academia.

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It’s a tale as old as time. How will we feed all the people on this planet of ours, especially with the global population set to reach 9 billion by 2050?

Proponents of organic agriculture have their answer: we must return to nature, our roots, a Jeffersonian ideal of what a farm really is. Meanwhile, advocates of conventional farming say we must reach for higher yields, using science and technology to push the limits of nature. The two are often at odds: a consortium of organic seed growers even took Monsanto to court based on the very fear that the agricultural giant might sue them for inadvertently growing their patented genetically modified seeds.

A recent paper published in the journal PLOS One showed that, at current growth rates, yields will be insufficient to meet the increased demand by 2050. Researchers agree that providing for the future will take a multitude of changes: closing yield gaps, shifting to more plant-based diets, and decreased waste. In addition, many studies suggest that land sparing is the best approach to feed the world and maintain biodiversity. But, any strategy to mitigate food insecurity must take a multi-disciplinary approach and be examined on a crop- and location-specific basis.

"Yield Trends Are Insufficient to Double Global Crop Production by 2050"

“Yield Trends Are Insufficient to Double Global Crop Production by 2050″
The dotted line shows the yield increases needed to meet global demand by 2050. The solid lines show where current yield increase trends will get production.

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On Monday, the Financial Times published an editorial praising the United Kingdom’s government for its “provisional approval” of a new in vitro fertilization (IVF) procedure aimed at ending rare diseases that occur in mitochondrial DNA.

The UK has showed surprising concern for scientific method and expert opinion as it has considered the novel form of genetic engineering that promises to cure a handful of babies each year of debilitating diseases. In addition, it has displayed foresight in developing regulations for the method before polarizing politicians and mad Members of Parliament attempt to debunk the science with phony arguments and trap innovation in a corner of unwieldy regulations.

Mitochondria are small energy packets within our cells that, when defective, can lead to serious disorders affecting cells that use the most energy: brain, liver, and heart cells among them. One in 6,500 babies is born with a serious mitochondrial disorder for which there currently is no cure. Because mitochondria are only inherited from a mother’s egg, scientists have developed a method of transferring nuclear DNA (a fertilized egg) into a donor egg with healthy mitochondria, leading to a healthy baby.

Human mitochondrial DNA contain a grand total of 37 genes, making up a paltry 0.1 percent of the entire human genome. The claim that babies produced through this novel method are the product of three parents (the “natural” mother and father, plus the donor egg, free of mutated mitochondrial DNA) is farce. Mitochondrial DNA are used for energy production, nothing more.

The Human Fertilisation and Embryology Authority (HFEA) of the UK conducted a survey of the public, finding widespread support for the form of genetic engineering. Now, the government, with the continued aid of the Chief Medical Officer, Secretary of State for Health, and the HFEA are set to draft regulations for the IVF procedure to be considered in parliament next year.

“Scientists have developed ground-breaking new procedures which could stop these diseases from being passed on, bringing hope to many families seeking to prevent their future children inheriting them. It’s only right that we look to introduce this life-saving treatment as soon as we can,” Chief Medical Officer Dame Sally Davies said.

Science, regulated by scientists? Sounds dreamy, doesn’t it?

Instead of invoking the precautionary principle, as the European Union has done with genetically modified organisms (as Fran Smith describes here), the UK is letting science guide policy. Instead of prohibiting a genetic engineering procedure that has the potential to save lives, the government has anticipated controversy and public outcry, getting its scientific house in order so it can move forward with common-sense regulation. It has been careful to point out that this is not a step towards a brave new world of “test tube babies,” but a simple, scientifically sound solution that can help eliminate a devastating group of diseases.

Have a listen here.

Senior Fellow Greg Conko discusses his new paper, “Is There a Future for Generic Biotech Crops? Regulatory Reform Is Needed for a Viable Post-Patent Industry.” Patents will soon expire for several popular biotech crops, opening the way for cheaper generic versions. But because, unlike prescription drugs, biotech crops have to be re-approved every few years, the future of generic biotech crops is very much in doubt. Conko recommends getting rid of re-approval requirements to put them on the same footing as other products.

Writing in the Daily Caller, legal commentator Walter Olson says that California’s Proposition 37 is bad policy that will only enrich opportunistic lawyers:

Prop. 37 on this fall’s California ballot, pleasantly billed as the Right to Know campaign, would require labeling of food with genetically modified (GMO/GE) ingredients. Backers say Europe already has similar rules and there’s no reason California shouldn’t follow suit. And even though health fears about GMO/GE products have been debunked by virtually every scientific authority to look into the matter — from the AMA to the World Health Organization, and including science reporting in such perhaps unexpected venues as Mother Jones and the Huffington Post — voters in a new Pepperdine poll still approve of the idea by a lopsided 69 to 22 percent. After all, how much could it cost just to put labels on foods?

We may soon find out. California’s fabled Proposition 65, enacted in 1986, requires the labeling of products that expose consumers to substances linked to cancer. That’s a pleasant-sounding idea too, but 26 years later the law has benefited almost no one but litigators. Even as cancer remains just as much of a problem in California as elsewhere, a cadre of lawyers in the state have made many, many tens of millions of dollars filing inadequate-labeling suits against purveyors of such products as candles, fireplace logs, Christmas lights, hammers, billiard cue chalk, matches, grilled chicken, life-saving drugs, brass doorknobs, car exhaust in parking garages, and on and on. (Most of the money in the resulting settlements goes to the lawyers, which is one reason defendants often describe Prop 65 litigation as legalized extortion.)

Weirdly, it might even reduce the availability of certain non-GMO foods, those currently distributed by middlemen that currently sell mostly GMO foods, and don’t want to establish parallel tracks for GMO and non-GMO foods: “By some estimates, 70 percent of the current American food supply would need a ‘contains GMOs’ label” under Prop. 37,” notes Olson in the article. Proposition 37′s enormous documentation burdens and liability risks will have a large chilling effect on suppliers.

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A small food company in Canada has grown an apple that doesn’t turn brown after being sliced.

Not everyone thinks it’s a great idea. A representative for incumbent apple growers told The New York Times, “We don’t think it’s in the best interest of the apple industry of the United States to have that product in the marketplace at this time.”

This translates roughly to, “We think consumers will prefer this product to ours, and will hurt our bottom line. Therefore, regulators should keep these things off the market for us.”

I’d rather consumers decide on the non-browning apple’s merits, thank you.