Raise your hand if you’ve ever eaten a wild cow or chicken.

Not sitting in front of your computer screen with your arm in the air, are you? With the exception of the occasional bit of boar or venison, virtually every piece of meat Americans consume is cultivated for the purpose of being devoured.

Fish, of course, are different. When we tuck into a swordfish steak or halibut filet, we generally expect that it was caught in the open ocean. And yet, the efficiencies of aquaculture—or cultivating freshwater and saltwater fish under controlled conditions—are becoming ever more a part of our seafood diet.

Aquaculture is a divisive topic, pitting those who fear its potential to pollute ocean waters and wild fishes’ gene pools against those who see the possibility of alleviating pressure on traditional fisheries and providing an additional source of protein. Commercial fishermen frequently ally with environmental groups, their typical adversaries, to oppose the practice as one that will create additional competition for their product while potentially compromising the habitat and raising the specter of introducing non-native species to the marine environment that could outcompete their native counterparts.

This is a critical debate because seafood is big business. Americans consumed 4.83 billion pounds of fish in 2009—nearly 16 pounds per person. What’s striking is that 84 percent of that fish was imported, and fully half of our imports were farmed, not wild caught. The reality we must face is that as world population and prosperity increases, so too will the demand for fish, and we won’t be able to meet this demand solely with fish caught in the wild. Aquaculture will have to continue to play a role.

So what are our options to balance the demands of rising populations with aversion to aquaculture?

1. Become a nation of vegetarians.

In an ecologically ideal world, perhaps we would all go vegetarian. But let’s be real—that’s never going to happen. Because as Vincent Vega said during his debate with Jules about eating pig in the “Pulp Fiction” diner: “Bacon tastes good. Pork chops taste good.”

Rather than reprising Jules’s opinion about the gustatory merits of sewer rat, let’s just move on and say that—at least in the opinion of the hordes trooping into Red Lobster for their “Endless Shrimp” promotion—crustaceans also taste good. Ditto salmon, though comparing a farm-raised Atlantic salmon to a wild-caught Alaskan Chinook is a bit like comparing a Big Mac to Kobe beef.

In the land of the free (to choose our diet as we see fit) and the home of the brave (enough to attempt to eat the 72 oz. Big Texan steak in under an hour), tofu and tempeh, tasty as they may be, are unlikely to become a permanent replacement for surf and turf.

2. Increase wild harvest.

World fish harvest peaked in the mid-1990s at approximately 90 million metric tons per year, according to statistics from the Earth Policy Institute. It has leveled off since then, despite ongoing population growth and increasing fishing effort. More fishermen working harder to catch the same amount of fish is a recipe for disaster.

The United States has done more than any other nation to end overfishing, and those efforts should at some point begin to pay dividends by rebuilding fish populations leading to increased catch limits for fishermen. Still, no one expects that even the most optimistic scenarios will allow us to meet even our domestic demand for seafood exclusively from a sustainable wild harvest.

3. Increase our imports of farmed fish.

Every year the average value of U.S. seafood imports is $9 billion more than the value of our exports, making fish our second-largest natural resource trade deficit behind everyone’s favorite petroleum product, oil. Therefore, it’s a pretty good bet that our overseas suppliers would be only too happy to ratchet up their fish production and send us even more shrimp, salmon, tilapia, and catfish. But what would be the ramifications for the global environment? What about the implications for our own human health?

Foreign fish farms aren’t exactly models of sustainability—they’re often poorly regulated and sited with little or no attention to environmental factors. Shrimp is one of the worst offenders. A National Geographic report published in 2004 found that Southeast Asian shrimp farms accounted for up to 38 percent of the decline in the world’s mangrove areas—fragile coastal wetlands that protect shores from storm surge and serve as vital carbon sinks. The report also referenced a 1995 study by the American Society of Microbiology stipulating that “the use of antibiotics in aquaculture as potentially a leading cause of the evolution of antibiotic-resistant bacteria in humans.”

There are also health concerns. The United States suspended imports of some Chinese-farmed seafood in 2007 because samples contained residues of drugs banned from use in U.S. food production, including some that were not even approved under Chinese law. The Washington Post reported that fish had been found that “carried the tell-tale greenish tinge of malachite green, a disinfectant powder that has been banned in China for five years because it is a suspected carcinogen but is still commonly used.”

And The New York Times quoted a professor from Hong Kong who had found “heavy metals, mercury and flame retardants in fish samples we’ve tested.”

Expecting the U.S. government to catch every piece of tainted tilapia entering the U.S. food supply is naïve at best when the Food and Drug Administration and National Oceanic and Atmospheric Administration, or NOAA, have the capacity to inspect less than 2 percent of the seafood we import. So while foreign-farmed fish is clearly here to stay as part of the American diet, I won’t be putting it on my family’s dinner table.

4. Farm more fish domestically.

Last week the NOAA announced a new domestic aquaculture policy intended to support an increase in domestic marine aquaculture. As expected, the move was greeted with largely negative reactions from environmental groups and fishing industry organizations.

But as we’ve just discussed, Americans will continue to consume fish; our wild fisheries are, for the moment, running at capacity; and foreign sources of farmed fish are rife with unsustainable and even unhealthy management practices. So we really have but one alternative remaining: more domestic fish farming.

Aquaculture in U.S. waters allows our regulators to oversee the inputs to the system more stringently. Still, it doesn’t solve many of the broader lingering concerns about fish farming, such as how to reduce the amount of wild fish that must go into feeding domesticated ones, or how to prevent escapes of farmed stock that could then interbreed with or even outcompete their wild counterparts.

NOAA’s policy prioritizes research into alleviating the lingering problems with aquaculture with its goals to “ensure … decisions protect wild species and healthy, productive, and resilient ocean ecosystems,” and “advance scientific knowledge concerning sustainable aquaculture.” But the policy is short on actual concrete steps to achieve the overall objective to “encourage and foster sustainable aquaculture development.”

In a statement about NOAA’s policy announcement, the consumer protection group Food and Water Watch called aquaculture “a filthy way to produce fish.” Perhaps, but is the alternative then to put increased pressure on our already maxed-out wild fisheries? Or is it to stop eating fish and seek other protein sources? If fish farming is “filthy,” then what are we to make of other large-scale livestock operations?

According to a report released last week by Conservation International and the WorldFish Center, fish are more efficient than either cows or pigs at converting feed to protein, and have dramatically lower potential to cause eutrophication from runoff of animal waste and pesticides and fertilizers used to grow the crops that feed the livestock. Not unrelated was another announcement from NOAA that this year’s dead zone in the Gulf of Mexico will be the largest ever—bigger than the state of New Hampshire. Dead zones are areas of the ocean in which nutrient-rich, polluted runoff saps oxygen from the sea and kills anything that can’t swim away from the toxins. Agriculture and livestock operations are major contributors to these phenomena.

As we meet our growing need for affordable sources of protein, NOAA is inevitably correct to begin seeking policies that acknowledge and attempt to solve problems rather than ignoring the reality that fish farming is here to stay. Addressing these needs will require a concerted effort to pursue ecological and sociological solutions to reduce the environmental impact of aquaculture and ensure a safe, sustainable seafood supply.

Michael Conathan is the Director of Ocean Policy at American Progress. You can view this article at CAP’s website, where you can also read more articles from the “Fish on Fridays” series.

In many cases, wild fisheries around the world have reached or exceeded their maximum sustainable harvest; the United Nations is projecting a 40 million ton seafood shortage by 2030. The $50 billion worldwide marine aquaculture industry— the deliberate farming of ocean species that provides half the world’s edible seafood—is the fastest growing form of food production in the world. Seafood provides a valuable supplement for a diversified and nutritious diet. It provides not only high-value protein, but also represents an important source of a wide range of micronutrients, minerals, and fatty acids and amino acids. Since few precious and finite freshwater resources are required for farming fish from the ocean, seafood could be a solution for global food and water security.

Open-ocean marine aquaculture, the free range of the sea

Marine aquaculture has several advantages over traditional capture fisheries. Since cultured fish are kept in a relatively controlled environment, it is possible to monitor production and predict the output and harvest. This makes it possible to adapt the harvest according to market demand and ensure the right size, quality, and volume of the fish at the most opportune time. These factors result in lower production costs and higher profits.

Conventional aquaculture, however, has numerous challenges that must be addressed as well. Penning lots of fish together in farms generates waste from feces and unconsumed commercial feed. These wastes can carry disease and the phosphate and nitrates in the mix can cause algal blooms that suck oxygen from the water, leaving it uninhabitable. Conventional near-shore cages presently used in salmon farming have become excessively dependent upon pesticides and antibiotics to combat diseases that are rampant in highly concentrated farming conditions—not unlike industrial-scale hog, poultry, and cattle farming on land.

Shrimp farms similarly are frequently overharvested and depleted within in a few years in many developing countries, leading to a continuum of destruction of coastal areas. They also depend on staggering amounts of antibiotics, fungicides, algaecides, and pesticides, and are polluting and water intensive. Nearly half the loss of mangroves in the world has been attributed to unsustainable shrimp farming.

But new techniques being developed in open-ocean fish cultivation can address many of these problems. “Open-ocean” aquaculture is an emerging concept that uses submersible cages deployed in deep water to produce farmed seafood while minimizing the environmental footprint. Farming locations are sited where optimum currents and other favorable conditions soften the footprint on the sea. One might think of open-ocean aquaculture as analogous in some ways to free range in terrestrial farming.

Modern open-ocean techniques use integrated multitrophic aquaculture, or IMTA, to address several of the problems of conventional aquaculture. IMTA uses waste from one species, salmon and shrimp for example, as the food or fertilizer for other species such as shellfish and seaweed. Data show that when seaweed or kelp are grown near fish cages it absorbs much of the excess dissolved inorganic nutrients, such as nitrogen and phosphorus, and increases its biomass 46 percent faster than when grown about a mile away from the reference site. Meanwhile bivalve shellfish feed on the organic particulates and grow 50 percent faster. This accelerated growth turns the natural recycling into an economic benefit. Despite concerns that the shellfish and seaweeds might be reservoirs for diseases that could affect the fish, scientists in Norway and Canada have observed that, to the contrary, mussels act as a bio filter, destroying the viruses responsible for fish diseases, such as infectious salmon anemia.

Critics also assert that aquaculture doesn’t alleviate pressure on fish feed stocks because many species of farmed fish are fed fishmeal and fish oil. In response to this concern, many farming operations are using plant-based protein sources as a sustainable and cost-effective substitute or supplement to traditional fishmeal protein. Soy-based protein, for example, is a promising substitute because of its nutritional profile, low cost, and consistent availability.

Alternative protein sources already provide from one- to two-thirds of the dietary protein in commercial feed that is supplied for the cultivation of fish. Soy-based protein can provide up to 40 percent of dietary protein in fish feed without significantly affecting the feed conversion ratio, the protein efficiency ratio, or the net protein utilization—in essence, without impacting the health or nutritional value of the fish. In the laboratory, 100 percent replacement of fishmeal protein in feed has been achieved, but it is not yet considered cost effective for commercial-scale production.

In sum, when properly designed, open-ocean marine aquaculture has the potential to make aquaculture a sustainable source of protein for our globally growing population. The “Blue Food Revolution” published in Scientific American February 2011 provides a balanced view for sustainably feeding a future population of 9 billion.

“The reality begs for a comparison rarely made: fish farming versus terrestrial farming. Done right, fish farming could provide much needed protein for the world while minimizing the expansion of land-based farming and the attendant environmental costs.”

Indeed, according to Neil Anthony Sims, the founder of Kona Blue Water Farms, sustainably designed marine aquaculture systems have the potential to produce staple fish species with the same ecological impact as anchovies, which have minimal environmental impacts because they are very low on the food chain. The Scientific American article also quotes Jane Lubchenco, director of the National Oceanic and Atmospheric Association:

“One of my goals has been to get to a position where, when people say food security, they don’t just mean grains and livestock but also fisheries and aquaculture.”

A sustainable food source for the Arabian Gulf

Open-ocean aquaculture could play a big role in addressing the pressing food and water needs of the Arabian Gulf region. According to the International Fund for Agricultural Development, or IFAD, Arab Gulf countries account for more than 5 percent of the world’s population but less than 1 percent of global water resources. Because of the arid desert climate, which is not conducive to large-scale farming, the region imports more than 80 percent of its food.  Furthermore, water used in agriculture consumes up to 80 percent of the total water supply; therefore, subsidized agriculture schemes are unfeasible and unsustainable on a large scale.

The Arabian Sea has great potential for open-ocean marine aquaculture development. With 1,700 kilometers of coastline, Oman has untapped potential to exploit this valuable resource with the development of a marine aquaculture industry. The 200-mile exclusive economic zone, extending seaward into the Gulf of Oman and Arabian Sea, presents a promising proposition for diversifying and augmenting Oman’s oil-based economy. Moreover, there is a strong commitment from the sultanate to develop the aquaculture sector in a competitive and sustainable manner in harmony with the social, economic, cultural, and historic values of the country.

With nearly 2,000 kilometers of coastline contiguously south on the Arabian Sea, Yemen is also endowed with rich and bountiful fishing grounds for feeding its burgeoning population. Like Oman, the fisheries sector lags far behind the oil and gas industry, suffering from lack of infrastructure, proper organization, and modern technologies.

Yemen could be the first nation to completely run out of water in a few years and Sana’a could be the world’s first capital city to go dry as people flee from the parched outer reaches of the country. Water available across Yemen amounts to 100 to 200 cubic meters per person per year, far below the international water poverty line of 1,000 cubic meters. Groundwater reserves are being used faster than they can replenish themselves, especially in the Sana’a basin, where water once found 20 meters below the surface is now 200 meters deep. The government is considering a desalination plant for seawater, an expensive solution that may come too late. Another option is to cut down on the agriculture industry and import even more food than its current 85 percent. The best option would be the development of a marine aquaculture industry.

Growing the marine aquaculture industry in these countries must leverage modern scientific knowledge and engage in diligent monitoring in order to avoid the ecological pitfalls that have plagued conventional fish farms around the world. The governments in Yemen and Oman have been actively engaged in ensuring both aquatic and terrestrial development is done sustainably, and both countries have frameworks that require environmental monitoring prior to licensing. “Oman’s Ministry of Environment and Climate Affairs in particular is known for its strict enforcement of environmental regulation,” says Tim Huntington, who works with the sultanate frequently as founding director of Poseidon Aquatic Resource Management LTD.

Done sustainably, a marine aquaculture industry for the Arabian Sea would increase food security and mitigate the depletion of sparse water for agricultural resources. It would also create jobs, generate income, and help increase nonpetroleum exports, while resuscitating local fish stocks to revive the livelihoods of fisher folks in coastal communities.

Phil Cruver is a progressive social entrepreneur and president of KZO Sea Farms.

For years, public and food industry officials have maintained that the American food supply is one of the safest in the world. Yet in 1999, the Centers for Disease Control and Prevention  estimated that food borne pathogens caused 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths annually in the United States. Now, more than ten years later, American families still face the same meaningful risks of illness or death from their food. While incidents involving some foodborne microbes have declined significantly, others have not abated in years. While incidents involving some foodborne microbes have declined significantly, according to the CDC, others have not abated in years.

These everyday dangers are evident from periodic, dramatic nationwide outbreaks of foodborne illness. These range from the infamous 1993 Jack-in-the-Box hamburger E. coli outbreak that struck hundreds, including many children, to the recent 2008 salmonella outbreak—the largest ever—that federal officials mistakenly attributed to tomatoes, before belatedly identifying the Mexican jalapeno peppers that sickened over 1,200 Americans.

Federal food safety officials openly acknowledge the persistence of this public health threat. Last October, Commissioner of Food and Drugs Peggy Hamburg echoed the CDC’s 1999 statistics in Senate testimony, acknowledging that every year “millions of people in the United States suffer from food borne illness, hundreds of thousands are hospitalized, and thousands die.” This staggering toll in health is matched by a tremendous economic impact. Last month, the Pew Charitable Trusts and Georgetown University concluded that the American economy incurs annual economic losses of $152 billion from medical costs, disability, and losses to quality of life attributable to food borne illnesses.

Deficiencies in the regulation of the American food supply constitute the most serious and persistent gap in American consumer protection. But solving the problem requires a combination of legislation to strengthen oversight authority, resources necessary to implement reforms, and an administration with the courage to take on difficult political choices. Thus far, that elixir has proven as elusive as health insurance reform. Sporadic congressional interest, historic infighting between the two principal agencies responsible for food safety, the Food and Drug Administration and the U.S. Department of Agriculture, and effective opposition from food producers and agricultural interests, have all but assured for many years that meaningful food safety reforms did not occur. But the chances of real reform are looking healthy.

This year, the possibility of action is significant. In the House of Representatives, Congressman John Dingell’s (D-MI) H.R. 2749, the Food Safety Enhancement Act of 2009, moved quickly last summer through committee markup and passed the House by a commanding 280-150 vote. The legislation would provide FDA with stronger authority to conduct inspections, mandate performance standards and preventive controls, and review records in order to trace outbreaks and unsafe food imports. The FDA would also strengthen nationwide laboratory capacity to test food samples and gain clear authority to mandate recalls of contaminated food. While the agency can mandate recalls for medical devices, it currently lacks the authority to do the same for contaminated food products. According to a 2010 Government Accountability Office report, “Limitations in FDA’s food recall authorities heighten the risk that unsafe food will remain in the food supply.” Under the proposed legislation, the agency would even have the power to quarantine regions where it suspects outbreaks originate. An effective combination of regulatory reforms and legislative compromises, the bill has broad bipartisan support, as well as the support, or absence of opposition, from regulated food industries and agricultural interests.

As Republican Congressman Shimkus (R-IL), a leading member of the House Energy and Commerce Committee, said, “We just couldn’t sit on the sidelines anymore as we saw case after case of food-borne illnesses. We had to come together in a way to address this.”

In the Senate, Richard Durbin’s (D-IL) S. 519, the FDA Food Safety Modernization Act, moved swiftly by voice vote through committee and is expected to reach the floor this month. The legislation has been amended to reflect reasonable compromises that have the bipartisan support of key senators, including Senate Health, Education, Labor, and Pensions Committee Chairman Tom Harkin (D-IA), fellow Democratic Senator Chris Dodd (CT), and Republican Senators Mike Enzi (WY) and Judd Gregg (NH). Like H.R. 2749, the Senate legislation strengthens FDA authority to regulate food, increase inspections, establish science-based standards, and better cope with the ever-expanding volume of imported foods.

Just as important, the Obama administration has heightened enforcement of consumer protections, selecting new, like-minded leadership at FDA and USDA committed to better coordinating their work and improving federal oversight of food safety. Commissioner Hamburg is a physician and public health leader who considers food safety “a core public health issue.” Deputy Commissioner for Foods Mike Taylor is a widely respected leader in food safety, having served as USDA undersecretary for food safety, as well as an FDA deputy commissioner under former commissioner David Kessler. At USDA, deputy undersecretary for food safety Jerry Mande worked with Taylor at FDA and Dr. Elisabeth Hagen, the department’s chief medical officer, has been nominated as the new undersecretary for food safety. Finally, the administration has matched its rhetoric and appointments with funding: the FDA’s Fiscal Year 2011 budget calls for a $326 million increase to “transform” food safety through $88 million in appropriations and $239 million in industry-funded user fees.

If the Senate successfully completes ongoing negotiations on a managers’ amendment and can bring S. 519 to a floor vote, the remaining steps to enacting comprehensive food safety reforms will be few. With few major substantive differences between the House and Senate bills, a bipartisan Congress would have to stumble badly to fail to deliver a law to President Obama for his signature before it adjourns this year. Provided enactment of these new authorities can be matched with equal commitments in funding, the federal government will have secured and begun implementing landmark reforms that will improve the safety of the food supply and better protect the health of all Americans.

Paul Kim is a partner at Foley Hoag LLP, and former deputy staff director for health under Senator Edward M. Kennedy and counsel to Congressman Henry Waxman.

Back here on the ground, though, it’s still 1958.

As things stand in the United States, food producers do very little to keep bacteria, as well as other common food contaminants such as viruses and chemicals, in check. Dr. Marion Nestle is a New York University food specialist who has worked with the Food and Drug Administration to create food policy. “Right now, we don’t have a food safety system,” she tells Science Progress. But that is poised to change. This spring, the House of Representatives passed a plan to finally apply the same sort of risk-based strategy to our food supply as NASA uses for astronauts. (The legislative vehicle in the House is H.R. 2749, the Food Safety Enhancement Act.) The Senate is set to take up the debate in the next few weeks.

The fact is, there’s a crying need for some sort of strategic intervention. Odds are that you have a few unpleasant memories of eating something that made you sick—according to the Centers for Disease Control, 76 million Americas get sick from food each year, some 325,000 of whom end up in the hospital. “These are way more than tummy aches,” says Bill Marler, a Seattle attorney who specializes in food outbreak cases. During the infamous 1993 Jack in the Box outbreak, Marler represented a seven-year-old girl who spent 42 days in a coma. Once she came out of it, she had to learn to walk again. Then there are the 5,000 or so Americans who actually die each year from something they ate. People like Kyle Allgood, a two-year-old Utah boy whose mother fed him shakes blended with spinach in a bid to slip something healthy into his diet. The spinach, alas, was infected with a mutant strain of E. Coli known as 0157:H7. Kyle’s kidneys were under attack, and proved outmatched.

Safe food for the rest of us

The genius of the Hazard Analysis and Critical Control Points system, as NASA’s approach is known, is that it forgoes the myth that all foods are created equal and all food processing is equally risky. Vegetables often eaten raw, like the spinach Kyle Allgood ate, deserve to be tracked with a closer eye than produce that is, in common practice, heated to a kill point before it gets to the table. Fruits that producers cut into on the farm are also a risk—for instance in operations where harvesting and processing happen in the same space. The HACCP plan takes what science knows about what makes certain foods and certain processes a risk and uses our limited food safety resources to zero in on those weak points in the system. With those points identified, the Food and Drug Administration can, finally, come up with a plan that directs its attention where it is most needed The mind-blowing truth is that the FDA today inspects food facilities somewhere on the order of once a decade. Under the bill currently up for debate in Congress, low-risk facilities would see that rate increase to one visit every year and a half to three years. Higher-risk facilities would be inspected every six to twelve months.

There are a number of other provisions in the plan that aim to do one simple thing: give us more knowledge about where what we eat is coming from. As things stand, our dinner plates are really black holes of information. Where did that tomato come from? That avocado? That grated cheddar cheese? The truth is that that information is so scattered, so hard to find, that it very nearly doesn’t exist. No more, should advocates in Congress get their way. If the plan does pass, food will have a history. Under new traceability provisions, anyone who produces food in the United States will have to keep records of where the food came from before it got to them, and where it went when it left their shop. (There are exemptions for small farmers and direct-to-consumer operations like farm stands. More on that below.) Big operations will have to keep those records electronically, which is enormously helpful as public health officials start to look for patterns when outbreaks occur. And food facilities will—amazingly, for the first time—get unique identification numbers, so we know who’s who.

Fairly simple changes, but a significant enough shift from the current state-of-play to be revolutionary.

Because the fact of the matter is that not knowing where what we eat comes from causes all sorts of problems, particularly in a day and age where we might be eating a West Coast cucumber, East Coast corn, and soybeans from China all in the same meal. (Food importers will have to abide by many of the same requirements as domestic food operations.) To be fair, part of the challenge is that nature makes it tough to track exactly what of what we’ve eaten is making us ill. Common food-borne bacteria—E. Coli, Listeria, Salmonella—incubate for up to a few days. Donna Rosenbaum started Safe Tables Our Priority, or S.T.O.P., after her seven year-old daughter’s best friend was the first life claimed during the ’93 Jack in the Box outbreak. “What you’re throwing up today isn’t what made you sick,” she explains. But the bigger problem is that knowing so little about where and how our food was made means that, when coupled with a distributed food supply, what could be limited eruptions of food poisoning turn into full-blown outbreaks and public health debacles. In one 2007 case, more than 1,300 people in 43 U.S. states got sick from a strain of Salmonella. Researchers soon found that all had eaten fresh salsa. Beyond that, though, mystery and confusion reigned. First jalapeño peppers became the scapegoat. Then tomatoes.

Said Colorado Democrat Rep. Dianna DeGette during one congressional hearing, in a statement that would be comic if not for the thousand-plus people who suffered from the outbreak, “We could never really figure out what’s wrong with the salsa.”

“If you had better data,” says Bill Marler, “you could say ‘It’s from this lot from this day and this facility,’ rather than, ‘We’re recalling all the tomatoes.” That confusion brings tragedy. In Kyle Allgood’s sad case, the FDA knew for days that something was making people sick, but lacked enough information to pinpoint the particular cause and ask producers to pull their spinach from the market. Under current law, food recalls are all voluntary. Under the new plan, the FDA would be newly empowered to order a recall when conditions warrant.

Better data, especially in electronic form, would give public health officials a fighting chance at detecting and stopping outbreaks at their front end, rather than resort to simply cleaning up a mess once it has gotten out of hand. The plan before Congress would direct the CDC to develop a new epidemiological surveillance system that scours the data for signs of troubles in the food supply. What’s more, the public would be given access to generalized sets of that data. The Reverend Henry Whitehead, a medical amateur, played a role in determining how cholera works when he used publicly available data to track it back to its source during London’s late-19^th century cholera outbreak. Who’s to say that, with food data posted online, one of us might not help to spot and stop an outbreak before it spirals out of control?

Seasoning a plan for the national appetite

By anyone’s measure, government officials, especially those in the FDA and CDC, would be given considerable new power. When it comes to food safety, there will be more officials with more fingers in more pies, and that has some people worried. When Congress was considering H.R. 2749, there was an explosion of interest in the bill in the sustainable food movement, with a particular worry over how it would impact small farmers and farmers markets—exactly the sort of personal, people-centered food production and distribution many of us would like to see flourish.

And then there was the response on the political right, where the bill was read as an attempt by the federal government to wrap its hands around the American food supply, a particular sensitivity for those who prefer small government. (References to H.R. 2749 as the “Hitler Act” aren’t even the most heated thing you’ll read about it if you spend time on conservative blogs.) On the political right, what causes the most ire was the ID numbers for food facilities and the bill’s “traceability” requirements—which shares many of the same outlines as the National Animal Identification System, now voluntary, which some worry might shift into a mandatory livestock tracking program.

But for food safety advocates, the concerns with the new plan, and the Internet clamor that accompanied them, are misguided and overblown. Negotiations in the House dropped the annual per-facility registration fee from $1,000 down to $500 in deference to representatives from coastal farm states worried that the cost—an attempt to provide FDA with a steady pool of funding to pay for increased inspections—would simply be too burdensome for the small local cheese maker or family farm. Some small producers, particularly those who deal directly with consumers, are exempt from many of the plan’s more demanding requirements.

That said, those who have been tracking and bemoaning the rate at which American foods make Americans sick don’t see small size as a justification for not producing safe food. “Whether or not Kraft should meet the same standard as somebody who produces 20 pounds of cheese for their neighbors is one question,” says Rosenbaum, “but if you’re capable of producing a product that can kill someone, then you have to be on the lookout for that.” She cites so-called “bathtub cheese.” A delicacy in Latino communities in the United States, the homemade cheese also has a history of carrying dangerous levels of Listeria, and has been known to cause spontaneous abortions in pregnant women. When it comes to focusing on risky ingredients and risky ways of making food, “I can’t think of any reason why small farmers should be exempt from doing this,” says Nestle.

As for fears from the right that a risk-based food safety plan is Congress’s back door into a mandatory animal-tracking future, the truth is that thanks to the might of the agriculture industry and Congress’ weakness in the face of it, the plan stops well short of keeping tabs on every cow in America. In the United States, meat is the purview of U.S. Department of Agriculture, and the plan now before Congress limits itself to the Food and Drug Administration’s areas of oversight.

Concerns from the right, left, and middle need to take into account the fact that our current reactionary food system hurts farmers, big and small alike, and has a demonstrably negative impact on the ability of those who make food to live off their labors. When we can’t manage to figure out, as DeGette put it, “what’s wrong with the salsa,” everyone who grows or produces something that goes into the salsa suffers. When peanuts are making people sick, as we saw in this spring’s Salmonella bacteria outbreak that was eventually traced back to two peanut processing plants in Georgia and Texas, wary consumers swear off all peanuts, not just those that are actually no good. Produce rots in the fields. Good producers suffer. In the ’07 salsa outbreak, tomatoes were ultimately cleared, within the margin of reasonable doubt, with having anything to do with the Salmonella contamination. That was little consolation for the U.S. tomato industry, which lost an estimated $100 million as the situation dragged out for six long and destructive weeks.

With better data, government health officials are given better odds at detecting an outbreak early, isolating the cause, and issuing warnings that actually eliminate the threat without causing collateral damage on innocent producers. And what has happened in the past is that government safety officials, burned by having reacted slowly to outbreaks in the absence of solid information, drag their feet on lifting warnings once the actual health threat has passed—meaning that our reactions to dangerous foods in the United States now carry the double-whammy of both being too late for consumers and going on too long for producers. When bad food is making people sick, the goal, says Bill Marler, “is to hold the people responsible who are actually responsible”—both perfectly sensible and a sea change from how we currently do things.

A fresh start for FDA

Whether the plan, if it indeed passes the Senate as expected, manages to target food safety risks while allowing small producers to flourish and food producers of all sizes to thrive free from too much government involvement depends in large part on the Food and Drug Administration. The FDA’s track record when it comes to being smart about making food safe is, by general consensus in and out of the agency, decidedly mixed. But there are hopeful signs. Just last week, the agency opened the doors on a new online Reportable Food Registry where producers can quickly inform FDA when a case of food contamination crops up. And new administrators appointed by the Obama administration are pushing to make the agency more transparent and engage the public in its work. During this spring’s Salmonella peanut outbreak, for example, the FDA reaction reflected a more aggressive and considered approach, using its website to post as much as it knew about what was making people sick, in as timely a way as possible, including pointing out what outside scientific experts had to say.

The hope is that by calling on the FDA to use what NASA and others have figured out about managing food risks, and by providing them with the resources necessary to actually put that knowledge to use, we can shrink the number of outbreaks that occur, spot them when they happen, limit the damage they do, and return business back to normal as quickly as possible. It’s too late for Kyle Allgood and the many thousands of other Americans killed or seriously injured by what they ate. But we owe it to them to use the best of what science knows to give the rest of us a fighting chance.

Nancy Scola is a writer in Brooklyn, NY.

Agricultural innovations through modern biotechnology have delivered significant economic, environmental, health and consumer benefits in recent years, but the full potential is even greater. Producers have embraced these innovations wherever they have had access, and consumers have purchased everything produced. The principal obstacle to additional innovations that will extend and expand benefits even further is ill-considered and scientifically unjustified or illogically implemented regulation. While the United States has had a comparative advantage over many other countries with a regulatory regime more closely anchored in science than most, regulations and implementation have not kept pace with scientific advances and accumulated experience.

The United States is the leading exporter of agricultural products in the world with $82 billion worth of goods exported in 2007, the last year for which complete data are available.^[2] Our nation boasts a $12 billion net positive trade balance in agriculture, and is the world’s second-largest agricultural producer (after China) with an estimated market of value of over $200 billion in 2007. The United States is the world’s leading producer of major products such as maize, soybeans, beef and milk. In recent years, productivity has increased and costs constrained through the use of innovative technologies developed through U.S. investment in agricultural research. Seeds improved through modern biotechnology have made a major contribution to U.S. agriculture; the United States leads the way globally in area planted with genetically engineered crops.^[3]

A major reason for this has been the clear delineation of regulatory requirements and authorities, and a system that (usually) delivers predictable decisions in a timely manner. But regulatory requirements and, even more importantly, their implementation, have not kept pace with increased understanding and experience. All domesticated crops have been extensively genetically modified during millennia of plant breeding and improvement, but breeding methods for the introduction of useful traits into crops have been markedly improved in recent years. Agricultural products derived through modern biotechnology—for the purposes of this paper, in vitro recombinant DNA , or rDNA techniques coupled with transformation^[4]—are now a major and increasing part of global commerce.

The techniques of in vitro gene transfer are faster, more precise, more predictable, and better defined than older methods of catalyzing the genetic modification of crops^[5]. By expanding the selection of genes that can be incorporated into new varieties to include genes from essentially all living organisms, recombinant DNA technology allows researchers to introduce new beneficial traits that would be difficult or impossible to create with any other breeding technology. This has allowed for the development and commercialization of crops with innovative improvements in performance. In the United States today, 86 percent of the cotton harvest, 92 percent of soybeans, and more than 80 percent of the corn harvest consist of varieties improved through biotechnology.^[6]

In a world where global agricultural commodity trade is increasingly competitive, improved qualities, value, and production efficiencies provided through biotechnology have preserved jobs here at home, especially in rural areas, by enabling U.S. farmers to remain powerful players in the global market.^[7] While the number of individuals directly involved in farming continues to decline,^[8] other jobs related to agricultural production are on the rise^[9]—with a portion of the increase coming from high paying jobs in biotechnology and related science fields. And the United States continues to retain a leading global role as agricultural exporter despite dramatic increases in production from other countries, including those with much lower labor costs.^[10]

Although the food and agricultural sector appears secure and profitable, both U.S. and global agriculture face a staggering array of challenges. These include factors as varied as shrinking land and water resources, rising energy costs, the effects of global climate change, and competition between food and industrial (biofuel) uses for agricultural products.^[11] Recent events have shattered the illusion that there is a surplus of food in the world, and world food reserves have recently been at an all time low of 53 days.^[12] Over 850 million people are malnourished, most of them in developing countries, and over 1.2 billion live on less than a dollar a day.^[13] Despite years of international efforts by affluent developed countries led by the United States, after decades of decline the number of poor and hungry in the world is again growing in parallel with increasing population^[14].

The upshot: a simultaneously looming humanitarian crisis and a potential source of great political instability—food and water shortages—will drive future global politics. This approaching catastrophe, however, is not preordained, even though the serious challenges posed by food and water shortages are real and growing. The Obama administration can take concrete steps to stimulate more ambitious and widespread innovation that would unfetter the tools needed to address these challenges. The specific measures proposed in this paper would stimulate the process of innovation in seed improvement. Improved crop varieties resulting from these innovations would enable the production of more food, feed, and fiber with lower inputs, reduced environmental impacts, and greater profitability. Such consequences would be economically beneficial to all players in the chain from farm to fork, but perhaps felt most acutely and directly by agricultural producers themselves, boosting the viability of rural communities. As argued in the following pages, several things are needed:

• A realignment of regulations so that oversight is, in fact, anchored in up-to-date scientific understanding and real world experience, and focused on unknowns that may poses risks in need of management, while reducing the burdens on innovations that have been so widely adopted as now to be accepted as conventional
• A more active program of international diplomacy to share information with other countries on the impacts of biotech improvements to agriculture, and the widely shared economic uplift thus enabled
• A more active and coordinated educational outreach program implemented by regulatory agencies and coordinated by diplomats to illuminate the conditions required to enable the widest dissemination of such innovations and their benefits, including strong intellectual property rights and science-based approaches to regulation and risk management.

In the analysis that follows, this report will detail the role of agricultural biotechnology in the United States and around the globe. It will examine issues inhibiting the application of potentially beneficial technologies, including the effects of scientifically unjustifiable and disproportionate regulation and the malign influence of special interest opposition groups. And it will present specific recommendations to improve an enabling environment in which the best of U.S. science and technology can be applied to the national and global challenges that confront us and will define our future.

Global Adoption of Agricultural Biotechnology

The primary biotechnology crops planted in the world today are insect protected and/or herbicide tolerant varieties of corn, soybeans, cotton, and canola. Brookes & Barfoot show net benefits at the farm level of $6.94 billion in 2006 and $33.8 billion over the prior eleven years.^[15] They also show a 286 million kilogram reduction in pesticide applications leading to a 15.4 percent decrease in the environmental impacts associated with their use. Associated greenhouse gas emissions were reduced during 2006 alone by an amount equivalent to removing 6.56 million cars from the road.

Data compiled by noted agricultural biologist Clive James^[16] shows for 2007 a 12 percent year-on-year increase of global biotech crop area (30 million acres/12.3 million hectares), with the total global area devoted to growing biotech improved crops at 282.4 million acres. These crops are grown by 12 million farmers around the world, of whom 11 million are smallholders in developing countries, thus reaffirming the scale-neutrality of the technology. Biotech improved crops are today grown in 23 countries, including 11 industrial and 12 developing nations.

While these data show rapid adoption and market penetration of products derived from plants improved through biotechnology, similar rapid growth has not been equally evident in animal husbandry and livestock improvement. Indeed, the transgenic animal product closest to wide commercial availability today (approved in the European Union, and in phase III clinical trials in the United States) is ATryn,^[17] an animal-derived drug that helps prevent excessive bleeding during surgical procedures.

The animal product perhaps closest to regulatory approval in the United States is a transgenic “advanced hybrid” salmon that reaches market size in half the usual time on 20 percent less food. This has been in the regulatory pipeline for the better part of a decade or more, and is reportedly nearing approval. Numerous other products and applications are in development but the lack of clear understanding on how these products would be regulated has created a perverse incentive that has discouraged investment.^[18]

Regulatory agencies have grappled with these issues for more than a decade, but a lack of attention by the outgoing Bush administration left proposals languishing in bureaucratic limbo for years, a defect partially remedied in recent weeks by publication of draft guidance by the Food and Drug Administration.^[19] Many uncertainties remain, including questions as to how several federal agencies with different or overlapping authorities will coordinate their responsibilities. But concrete decisions emerging from these agencies are the ultimate test and requirement, and a hurdle that remains to be cleared.

Constraints to Adoption

Dramatic as the advances and benefits from agricultural biotechnology have been to date, they represent only a small fraction of what is possible. While many plants improved through biotechnology have been field-tested,^[20]and at least 22 crops have been approved for food and feed use in the United States,^[21] the majority of the global trade in biotech-improved crops to date has involved only four plants: soybeans, cotton, corn (maize) and canola. The improvements delivered through biotechnology thus far have been primarily insect resistance and herbicide tolerance.

Biotechnology is capable of solving many more of the problems and challenges facing agriculture around the world than this short list suggests^[22]. Why are more of these solutions not available today? There are many contributing factors, but there is also wide agreement as to the major obstacle. James has described the impact of overly burdensome regulatory regimes on developing countries, but the critique is no less relevant to industrial nations:

“The most important constraint to biotech crops… is the lack of appropriate cost-effective and responsible regulation systems that incorporate all the lessons of a dozen years of regulation. Current regulatory systems… are usually unnecessarily cumbersome and in many cases it is impossible to implement the system to approve products which can cost up to US$1 million or more to deregulate… With the accumulated knowledge of the last dozen years it is now possible to design appropriate regulatory systems that are responsible, rigorous and yet not onerous, requiring only modest resources… Today, unnecessary and unjustified stringent standards… are denying… countries timely access to products such as golden rice, whilst millions die unnecessarily in the interim. This is a moral dilemma, where the demands of regulatory systems have become “the end and not the means”, overriding common sense, and where “the regulatory surgery may be successful but the patient died.”[23]

The problem, in fact, is larger than this indicates—a dispassionate review of the global experience to date with field testing and commercial growing of transgenic plants and the underlying science suggests that all existing regulatory regimes apply a level of scrutiny and control that is disproportionate to the risks they seek to manage.[24] Science shows that any regulatory review process that is triggered by the fact that an organism has been modified by in vitro rDNA techniques per se is unjustified. Numerous authoritative analyses have concluded that the potential hazards associated with crops improved through biotechnology are the same as those with which we are familiar from conventional crops.[25] Case in point: The European Commission concluded in 2001 that “the use of more precise technology and the greater regulatory scrutiny probably make (biotech derived foods) even safer than conventional plants and foods.”^[26] This conclusion has recently been reinforced by a study from the Joint Research Center of the European Commission.^[27]

These findings from the epicenter of political opposition to biotechnology in agriculture, the EU, have been confirmed in studies and experience around the world.^[28] Indeed, the only findings in the scientific literature which show significantly different levels of hazard between biotech improved crops and other crops favor biotech crops.[29] It is fair to ask, then, how it is possible to justify, other than through bureaucratic inertia and political pressure manufactured by interest groups,[30] a situation wherein the highest regulatory barriers to market entry are placed in the path of products that are better understood and demonstrably more productive, beneficial, and often safer than competing products?

Barriers to Trade

Policies adopted by the EU, for example, have created de facto trade barriers that discourage the development and use of transgenic crops. U.S. farmers have been reluctant to plant some biotech improved crops such as wheat, potato, and rice because these crops have not been approved by the EU regulatory system, and out of concern over potential loss of market share. The United States, Argentina, and Canada brought a World Trade Organization case against the EU, which was decided in their favor in 2005[31]. Yet the EU has so far been intransigent in agreeing to any resolution of the judgment against them.

Moreover, the EU has invested hundreds of millions of euros in various trade distorting measures, promoting fear and misinformation, and advancing their approach to regulation as a model for other countries.[32] EU support has been targeted at a variety of measures attempting to ensure that developing nations adhere to the Cartagena Biosafety Protocol by installing biosafety systems but which, in fact, create barriers to the adoption of transgenic crops. Not only is the EU unwilling to approve transgenic crops in a timely manner, but after approval for use transgenic crops are discriminated against by a mandatory labeling regime that requires segregation of transgenic from “conventional” crops, which adds 10 percent-to-20 percent to the cost of these commodities and foods prepared from them.[33]

What’s more, EU policies and EU civil organizations have focused on keeping biotechnology away from developing countries that most need to improve their agriculture.[34] This politicization of regulation has eroded the role of science and experience, leading to counterproductive policies that add enormous costs to the food and feed system, such as regulatory and compliance costs, the cost of segregation and testing, and numerous opportunity costs.

Bruce Ames and Lois Gold (University of California, Berkeley) have described this phenomenon as: “damage by distraction: regulating low hypothetical risks. Putting huge amounts of money into minuscule hypothetical risks has a negative impact on public health by diverting resources and distracting the public from major risks.”[35] The misplaced focus on GMOs also creates damage by diverting regulatory and consumer attention and resources away from real food safety issues, such as food borne pathogens and mycotoxins, which do real harm.

Barriers Created by Existing U.S. Policy & Regulations

In contrast to the EU, the United States relies on regulatory policy more firmly anchored in reliance on science-based risk assessment, in which regulators are directed to base decisions on data and experience rather than political considerations. Existing U.S. policy was set out in 1986,[36] and is widely known as the Coordinated Framework. The scientific consensus that plants improved through recombinant DNA techniques present no novel or unfamiliar risks by comparison with their conventional counterparts justified the use of existing legislative authority granted to the U.S. Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration.[37] Experience in the intervening years has produced nothing to cast doubt on this consensus. Each of these agencies has put in place regulations, promulgated policies, and adapted them over time, some repeatedly. Indeed, this system has, for the most part, entailed clear regulatory requirements and decisions taken by regulators have generally produced predictable results in a timely manner—affording the United States a comparative advantage over many other countries.

But the U.S. regulatory oversight system as it presently functions, is imperfect in the extent to which its regulatory burdens track credible risks or significant uncertainty. Vast experience has been accumulated under existing regulations, especially at USDA, but proposed updates to these regulations fall significantly short of changes justifiable on the basis of experience to date.[38] The situation is exacerbated by lawsuits and court decisions which appear to be driving USDA in the direction of repairing procedural vulnerabilities at the expense of regulatory reforms that would more closely align oversight with genuine risks and uncertainties.[39]

While a wholesale overhaul is not required, several updates and course corrections are overdue. The problems created by their absence are best seen by examination of some of the concrete innovations possible with modern agricultural biotechnology, and the disproportionate regulatory obstacles they face.

Improved production and quality of fruits and vegetables. There are a great many “minor” crops for which production is constrained by a disease, an insect pest, or another environmental stress or factor for which biotechnology could readily provide one or more solutions. The markets for these products are generally much smaller than those for major commodity crops, making the prospects for recovery of the costs of regulatory approval[40] through amortization of several years of market growth for new biotech varieties much more tenuous.

Improved production of medicines through plant made pharmaceuticals. Field trials of plants modified to become more productive and economical sources of innovative medicines have been burdened with and impeded by measures to impose isolation and containment out of proportion to any reasonable estimate of potential hazard. A classic example in this regard is the use of rice economically to produce lactoferrin as a medication to treat childhood diarrhea. Lactoferrin is a protein found in mothers’ milk. There is no indication its consumption would present any potential for harm, yet permits for field trials have been burdened with onerous requirements to ensure that pollen does not carry the lactoferrin gene beyond the test plots,[41] and absolutely no commingling of the experimental rice is permitted with other rice.

Reduced environmental impacts in large scale commodity crop production through improved weed control/herbicide tolerance. Many crop plants carry innate tolerances for exposure to different herbicides as a natural consequence of plant physiology and genetic variation in nature. Crops produced through biotechnology carrying similar phenotypes are subjected to intense scrutiny while those produced using older less precise methods can be marketed without any regulatory review. Experience with the newer herbicide tolerant crops has generated so robust an affirmation of safety that the burden of evidence should now be on those arguing for scrutiny greater than that applied to herbicide tolerance derived through mutagenesis and conventional breeding. Detailed and duplicative reviews for all biotech herbicide tolerant crops are beyond what can be justified by any data on hazard or experience in the field. Future regulatory reviews of herbicide tolerant crops, however derived, should focus only on any novel risks.

Improved pest control. Many different agricultural crops possess varying degrees of resistance to different potential pests. Crops enhanced through biotechnology to resist herbivorous insects (“plants with pesticidal properties”) are regulated by EPA under the same laws and with generally comparable methods applied to conventional pest control substances. In a dramatic and unprecedented departure, however, plants containing an insecticidal protein derived (through biotechnology) from Bacillus thuringiensis, or Bt, are required by EPA to be planted under a “resistance management plan.” EPA stipulates setting aside an area (usually 20 percent) for growing non-Bt plants as a means of forestalling the inevitable evolution of insect resistance. Integrated pest and resistance management are clearly valuable, but such “refugia” requirements have not before been imposed on other types of insect protected plants, nor have they been applied to use of Bt as a topical pesticide (e.g., as practiced by organic growers, in the only situation to date where, in fact, resistance has been seen to evolve in the field).

Resistance management is an issue of product longevity more than of environmental protection and it can be argued that issues of product longevity are better left to market forces. EPA should encourage innovation and good stewardship in pest management more effectively with a shift towards performance standards and away from rigid prescriptions. This would accelerate the development of pest protected plants incorporating multiple modes of action and other innovative approaches.

Improved cellulosic biomass production. Cellulosic biomass is widely used for myriad purposes: in the construction industry as structural material; throughout business, education, commerce and life through paper products; increasingly of late for energy, either directly or through production of ethanol or other energy storing compounds to concentrate energy and make it more easily transported. Several novel sources of cellulosic biomass (Miscanthus, switchgrass, Eucalyptus and poplars) are being genetically engineered in order to make them suitable for efficient and economical pulp and/or biofuel production. The greatest obstacles limiting their development and adoption are regulatory barriers that treat all biotech crops as a suspect class subject to heightened regulatory scrutiny. Regulatory agencies continue, for example, to impose significant constraints on biotech crops in R&D field trials to eliminate any potential for gene flow, even in cases where no possible harm to humans or the environment could result. It is difficult, for example, to imagine an unfamiliar risk from a plant modified to resist a well characterized herbicide, yet new crops containing resistance to such herbicides due to biotech manipulations are subject to scrutiny while similar crops produced conventionally are not.

Improved livestock production, Recombinant DNA technology can be used to improve livestock and companion animals in many ways—improved feed conversion and nutritional qualities, shortened time to market, resistance to disease, reduced environmental impacts, improved efficiency as sources of human medicines, and more. Although the emergence of policy guidance and regulations from the FDA has been slow, the principle obstacle here has not (yet) been disproportionate regulatory burdens so much as regulatory uncertainty caused by such delays. The primary cause of the delays appears to have been a failure by the White House Office of Management and Budget’s Office of Information and Regulatory Affairs to allow proposed regulatory guidance documents to be published for public comment.

A promising recent development has been the publication of guidance by the FDA[42] detailing how they would regulate transgenic animals and their products. The Agency has assigned responsibility to the Center for Veterinary Medicine to apply regulations governing new animal drugs. It remains to be seen if the resulting oversight will provide scrutiny at levels proportionate to the level of risk and in a timely manner, but it is clear that to unleash this technology and enable it to proceed at a pace dictated by the rate of scientific advance the remedy is simple: the Obama administration should renew the requirement for transparency, and more specifically proportional reviews and timely decisions. Future adaptations of regulations must be delivered through prompt publication of proposed policy documents and regulatory guidance by responsible agencies, accompanied by timely responses and decisions.

Lost opportunities and opportunity costs. Regulatory barriers, trade barriers, and the dissemination of deliberate misinformation about crops produced using modern biotechnology have had a chilling effect on adoption of existing approved varieties, and they have discouraged researchers and corporations from undertaking development projects that utilize rDNA technology. Nowhere has this had more damaging impact than in developing nations that suffer from recurrent food insecurity and hunger, and which desperately need to improve agricultural productivity and sustainability. The magnitude of these lost opportunities is difficult to calculate, however, if the productivity gains and environmental benefits reported for four major crops^[43] were extrapolated to all crops for which biotech solutions have not been adopted, the lost potential would obviously be enormous. This is setting aside the fact that higher yields and nutritionally enhanced crops such as Golden Rice might have saved millions of lives per year.^[44]

Policy Recommendations to Reignite Innovation in Agricultural Biotechnology

Biotechnology applied to agricultural has, for good reason, been described as Promethean.^[45] It promises to re-shape the relationship between humans and our environment in dramatically greener and more sustainable ways than anything that has gone before. Although the technological challenges remain formidable, the science accessible to us today would enable more rapid innovation than we have seen to date, primarily because of regulatory obstacles for which experience has over the past two decades eroded the scientific justification. There are a number of specific steps that could be taken to reduce or eliminate such obstacles.

Reform the US regulatory system. Regulations must be based in science and should be frequently updated to take into account the lessons gained from experience. Judicial decisions based on perceived procedural deficiencies^[46] should not be allowed to drive regulatory action in directions unsupported by science. The system should not seek zero risk as this is unattainable in the real world. Regulatory review should seek to establish that novel products are as safe as others in the marketplace. In making this evaluation regulators must take into account both the harms caused by present practices as well as opportunity costs, the potential benefits that would be lost by non-adoption. The degree of regulation should be commensurate with real risks and harms. Specifically:

• The trigger for regulatory review should be the novelty of the introduced trait (introduced by whatever method) and not the process used to introduce the trait. The degree of scrutiny should depend on the relative risk associated with the phenotype and the host when it can be shown that the methods used do not add to the risk. The system should have clear guidelines that quantitatively specify timely decision-making.
• Exempt phenotypes from regulatory review if they could be accomplished through classical methods. If a phenotype comparable to that under review could be produced by a variety of production methodologies (classical breeding vs. recombinant DNA modifications, for example) then there should be a strong presumption against any review process that would make it more difficult, for example, to see the rDNA product move into the field for R&D or commercial purposes when there is no scientific justification for such discrimination.
• Recognize that gene flow is a natural phenomenon and is not intrinsically hazardous. The potential for gene movement via pollen flow is a natural phenomenon. Regulatory agencies must stop treating gene flow as intrinsically hazardous, and shift their focus to appropriate risk management/mitigation in the rare cases where genes so disseminated could, in fact, present a genuine hazard.
• Shift to phenotype-based regulatory triggers. Agencies should transition from an event-based regulatory process to a phenotype-based process, as the hazard of a phenotype that is stably inherited has more to do with the distinguishing features of the phenotype than with the precise details of the process through which it was produced.
• Enhance effectiveness, adaptability, and public confidence by accelerating regulatory updates and transparency. To unleash this technology and enable it to proceed at a pace dictated by the rate of scientific advance the remedy is simple: the new administration should insist on transparency and require prompt publication of proposed policy documents and regulatory guidance by responsible agencies, which must then be tasked with timely responses to public comment. This will galvanize innovation not only in the animal biotech sector, which has suffered acutely in this regard, but broadly.

Fund outreach and education here and abroad. A program to counter misinformation and offer developing countries regulatory models that will create an enabling climate for biotechnology is essential. Regulators from USDA, FDA, and EPA should be a much more active and visible presence on the international stage and in multilateral fora, sharing the American experience with agricultural biotechnology and correcting misunderstandings fueled by opponents driven by concerns unanchored in data and experience. The Department of State should play a larger leadership and coordinating role focusing these efforts on countries of key strategic importance and global significance.

Make helping developing countries attain sustainable food security a major priority for U.S. foreign aid, open not only to biotechnology but to all technological innovation. Such a policy would be relatively inexpensive (by comparison with the costs of dealing with consequences of the alternatives, including inaction) and yield beneficial results on numerous fronts, including national security. Reversing the past three decades of decline of support, through USAID, for international agricultural research through the CGIAR^[47] would be a good first step.

Maintain strong intellectual property protection as an essential stimulus to investment. Intellectual property contained in the genetics of self-replicating plants is easily infringed. The administration should advocate for patent law and PTO administrative reforms that reward private investment in valuable agricultural innovations.

Conclusion

In summary, biotechnology applied to agriculture has enormous potential to enhance our ability to develop seeds for improved crops and for enhanced livestock to enable us to meet the food, feed and fiber challenges of a growing world and stressed ecosystems in coming years. Significant impediments are created by unwarranted or outdated regulatory burdens that could easily be removed. The resulting, stronger scientific basis for regulatory oversight will increase the efficiency of regulation designed to prevent or manage risks and uncertainties while enabling more rapid development of innovative, safer products. Benefits to human health, the environment, global political stability and national security would follow.

L. Val Giddings, Ph.D, is President, PrometheusAB, Inc. and Bruce M. Chassy, Ph.D., is Professor of Food Microbiology, Department of Food Science and Human Nutrition at the University of Illinois, Urbana.

Endnotes

^[1] Nina Fedoroff & Nancy Marie Brown. 2004. Mendel in the Kitchen: A Scientist’s View of Genetically Modified Foods. Joseph Henry Press, Washington, DC. 370pp. ISBN 0-309-09205-1.

^[2] http://usinfo.state.gov/products/pubs/economy-in-brief/page3.html

^[3] Clive James, 2008. Global Status of Commercialized Biotech/GM Crops, 2007. ISAAA Brief 37-2007: Executive Summary at http://www.isaaa.org/resources/publications/briefs/37/executivesummary/default.html.

^[4] Combining two or more DNA molecules in the laboratory, and then inserting the resulting DNA into the hereditary material of a plant or animal; also sometimes referred to as “transgenics” or (inaccurately) “GMOs” for Genetically Modified Organisms.

^[5] Chrispeels, Maarten & David E. Sadava. 1994. Plants, Genes & Crop Biotechnology (2^nd Edition). Jones & Bartlett, New York. ISBN-13: 9780763715861. also Fedoroff & Brown, 2004 (note 1 above).

^[6] Economic Research Service, USDA, 2008; see http://www.ers.usda.gov/Data/BiotechCrops/.

^[7] See http://www.ers.usda.gov/Data/FATUS/ .

^[8] See http://www.ers.usda.gov/StateFacts/US.htm.

^[9] See http://www.csrees.usda.gov/newsroom/news/2005news/USDA_05_Report2.pdf.

^[10] See http://web.worldbank.org/WBSITE/EXTERNAL/EXTDEC/EXTDECPROSPECTS/EXTGAT/0,,menuPK:547863~pagePK:64167702~piPK:64167676~theSitePK:547846,00.html and http://www.ers.usda.gov/Briefing/AgTrade/

^[11] See www.fao.org.

^[12] See http://www.discovery.org/a/5601.

^[13] See http://www.unmillenniumproject.org/documents/table_2.gif; and http://www.fao.org/newsroom/en/news/2006/1000433/index.html.

^[14] Evans, L.T. 1998. Feeding the Ten Billion. Cambridge, New York. ISBN 0 521 64685 5.

^[15] Graham Brookes & Peter Barfoot, 2008. Global Impact of Biotech Crops: Socio-Economic and Environmental Effects, 1996-2006. AgBioForum 11(1):21-38 at http://www.pgeconomics.co.uk/pdf/agbioforumpaper2008final.pdf.

^[16] James, 2008.

^[17] Scott Gottlieb & Matthew Wheeler, 2008. Genetically engineered animals and public health: Compelling benefits for health care, nutrition, the environment, and animal welfare. At http://www.bio.org/foodag/animals/ge_animal_benefits.pdf.

^[18] See http://www.bio.org/foodag/animals/ge_animal_benefits.pdf.

^[19] See FDA, 2008 (18 September), “Guidance for Industry 187, Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs” at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0394-gdl.pdf.

^[20] See USDA APHIS data on field trials at http://www.isb.vt.edu/cfdocs/biocharts1.cfm.

^[21] See the US Regulatory Agencies Unified Biotechnology Website at http://usbiotechreg.nbii.gov/database_pub.asp

[22] See, for example, Leonard P. Gianessi, Cressida S. Silvers, Sujatha Sankula, and Janet E. Carpenter, 2002. Plant Biotechnology: Current and Potential Impact for Improving Pest Management in US Agriculture. National Center for Food & Agricultural Policy, at http://www.ncfap.org/biotechcrops.html, and also Gabrielle J. Persley, 1990. Agricultural Biotechnology: Opportunities for International Development. CAB International. Wallingford, UK, 495pp. ISBN 0-85198-643-9.

^[23] James, 2008.

[24] Kalaitzandonakes K, Alston JM, Bradford KJ (2007) Compliance costs for regulatory approval of new biotech crops Nat Biotech 25: 509 – 511.

^[25] One of the earliest such studies was NAS 1987, Introduction of Recombinant-DNA Engineered Organisms Into the Environment; Key Issues. National Academy Press, Washington. 25pp. A more recent corroboration was Charles Kessler & Ioannis Economidis, 2001. EC-sponsored Research on Safety of Genetically Modified Organisms: A Review of Results. European Commission, Brussels. ISBN 92-894-1527-4. Additional authoritative examples are legion.

[26] European Commission, Press Release of 8 October 2001, announcing the release of 15 year study incl 81 projects/70M euros, 400 teams. See (http://ec.europa.eu/research/fp5/eag-gmo.html and http://ec.europa.eu/research/fp5/pdf/eag-gmo.pdf ).

^[27] See http://ec.europa.eu/dgs/jrc/downloads/jrc_20080910_gmo_study_en.pdf.

^[28] See, for example, http://www.nap.edu/openbook.php?record_id=9889.

^[29] See, for example: Munkvold, G. P., Hellmich, R. L., Showers, W. B. 1997. Reduced fusarium ear rot and symptomless infection in kernels of maize genetically engineered for European corn borer resistance. Phytopathology 87:1071-1077; & Munkvold, G. P., Hellmich, R. L., Rice, L. G. 1999. Comparison of fumonisin concentrations in kernels of transgenic Bt maize hybrids and non-transgenic hybrids. Plant Disease 83:130-138. .

^[30] Pressure groups opposed to agricultural biotechnology, such as Friends of the Earth, Greenpeace, and the Soil Association (UK) and a small handful of sister groups have prosecuted major campaigns in opposition to agricultural biotechnology.

^[31] See http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm.

^[32] See http://www.economist.com/world/europe/displaystory.cfm?story_id=9832900 and http://www.foodnavigator.com/Publications/Food-Beverage-Nutrition/NutraIngredients/Regulation/EU-regulations-attract-global-attention/?c=BsQPsnsxVtbvnOzYL7sWTw==

^[33] See http://www.pgeconomics.co.uk/pdf/Global_GM_Market.pdf and Kalaitzandonakes, N., R. Maltsbarger, & J. Barnes, 2001. The costs of identity preservation in the global food system. Canadian Journal of Agricultural Economics 49:605-615.

^[34] Robert Paarlberg, 2008. Starved for Science: How biotechnology is being kept out of Africa. Harvard University Press, 235pp. ISBN-13: 978-0-674-02973-6; also, 2001. The Politics of Precaution. Johns Hopkins University Press. 181pp. ISBN 0-8018-6668-5; and Jon Entine (ed.), 2006. Let Them Eat Precaution. AEI Press, 203pp. ISBN 0-8447-4200-7.

^[35] Bruce N. Ames & Lois Swirsky Gold, 2000. Paracelsus to parascience: the environmental cancer distraction. Mutation Research 447:3-13.

^[36]See Office of Science & Technology Policy, Coordinated framework for regulation of biotechnology; Announcement of Policy and Notice for public Comment. 51 FR 23,392, 26 June, 1986 also at http://usbiotechreg.nbii.gov/ .

^[37] See OECD 1986: Recombinant DNA Safety Considerations – Safety considerations for industrial, agricultural and environmental applications of organisms derived by recombinant DNA techniques. ISBN 92-64-12857-3; and National Research Council, 1989. Field Testing Genetically Modified Organisms: Framework for Decision. Washington, DC, National Academy Press. ISBN

ISBN-10: 0-309-04076-0 ;

^[38] See, for example, USDA proposals and comments to the APHIS Docket at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0023.

^[39] See, for example, http://www.ca9.uscourts.gov/ca9/newopinions.nsf/4C054C94994E1DB3882574B80059C7B9/$file/0716458.pdf?openelement.

^[40] http://www.pewtrusts.org/news_room_detail.aspx?id=24758

^[41] See, for example, http://www.epa.gov/EPA-IMPACT/2005/May/Day-13/i9606.htm.

^[42] FDA, 2008.

^[43] Brookes & Barfoot, 2008.

^[44] Ingo Potrykus, 2001, “Golden Rice & Beyond: Emotions are the problem, not rational discourse.” Plant Physiology 125:1157-61 at http://www.plantphysiol.org/cgi/content/full/125/3/1157.

^[45] See http://www.worldbank.org/html/cgiar/publications/prometh/pscont.html; also Gabrielle J. Persley, 1990. Beyond Mendel’s Garden: Biotechnology in the Service of World Agriculture. CABI Press, Wallingford, UK. ISBN 0-85198-682-X; and Gordon Conway, 1997. The Doubly Green Revolution – Food for all in the 21^st Century. Comstock Publishing, New York. ISBN -13- 9780801486104.

^[46] See, e.g., Geertson Seed Farms v. Johanns, No. 06-01075, 2007 WL 518624 (N.D. Cal. Feb. 13, 2007).

^[47] The Consultative Group for International Agricultural Research, see http://www.cgiar.org/.

Today, we’ve posted the first two commentaries on this important issue. Paul B. Thompson of Michigan State University asks, “Can Agricultural Biotechnology Help the Poor?” It can, he argues, but progressives need to step back and look at the philosophical underpinnings of development strategies in order to fully comprehend the issues at stake. As well, Doug Gurian-Sherman of the Union of Concerned Scientists looks at the proposed Global Food Security Act of 2009 and interrogates why it singles out “genetically modified technology,” as opposed to other methods, as a way to boost crop yields. “Genetic Engineering Comes Up Short,” when compared to conventional techniques, he argues.

Rep. John Dingell (D-MI), who co-sponsors the “Food Safety Enhancement Act of 2009″ with Rep. Henry Waxman (D-CA), noted on the committee site that “Consumer confidence in the nation’s food supply is low.”

The legislation would further give the FDA greater power to prevent problems through heightened inspection regiments, as well as the authority to initiate mandatory recalls in the event of a contamination or outbreak.

Waxman notes as well on the committee site that the poor state of the food safety system is a threat not just to public health, but to food companies themselves. Hence, Layton reports that “the proposal would put greater responsibility on growers, manufacturers and food handlers by requiring them to identify contamination risks, document the steps they take to prevent them and provide those records to federal regulators.”

Such a system would also present an opportunity for the FDA to provide relevant portions of those records to the public in an accessible format—and the bill summary indicates that the registry would require unique identification numbers for food facilities and importers. This information could make a welcome future addition to Data.gov, so that third parties and citizen groups can keep up with the safety of what’s in the their shopping cart.

Image: AP/John Bazemore

However, a budget increase of 5.7 percent, to $2.4 billion, along with Commissioner Hamburg and deputy Sharfstein’s plan for improving food safety through partnerships with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, the National Institutes of Health, the pharmaceutical and biotechnology industries, individual states, and various academics should bring hope for the safety of the U.S. food supply yet. The FDA and USDA will continue to follow the salmonella outbreak from contaminated peanut butter earlier this year that sickened hundreds of Americans and is responsible for several deaths.

Referring to the outbreak, Hamburg and Sharfstein write: “It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls.” With this recognition, Hamburg and Sharfstein intend to work with Congress to update food safety laws that will hopefully prevent future “Peanutgates.”

In the spirit of public health, Hamburg and Sharfstein acknowledge “the urgent need to develop and produce a vaccine against H1N1 influenza virus,” which is currently being studied at the FDA. “The agency’s success will be determined by the nation’s access to a safe and effective vaccine,” said Hamburg and Sharfstein.

Image: flickr.com/Robert Couse-Baker

The American Medical Association devoted the entire April edition of its pediatric publication to disseminating the latest research. First Lady Michelle Obama is educating the nation about healthy eating through a regular field trip to the White House vegetable garden. And the William J. Clinton Foundation has made this a signature issue, putting pressure on companies to produce healthier products.

So why are the nation’s school boards fighting in Congress to protect their right to serve junk food to America’s school children? Well, profits and provincialism both have something to do with it, never mind the importance of good nutrition to the health, well-being, and educational opportunities for all our children.

Mandating minimal nutritional standards for food served in schools is a relatively modest proposal now before Congress—modest because schools must already abide by these standards in the free- and reduced-priced meals that are paid for by the federal government. Yet junk food still is commonplace in cafeterias, concession stands, and vending machines in schools across the country.

Evidence abounds that our kids need to eat healthier and that local school boards will not adequately address this issue on their own. But in recent testimony before Congress, the nation’s school boards decried national nutritional standards for what can be served to students in school.

At a time when America’s economic salvation and leadership in the world are contingent on dramatically improving outcomes in public education, minimal nutritional standards are a no-brainer. Yet the National School Boards Association thinks we should fight these issues out district-by-district so that we can have almost 15,000 different nutritional standards across the country—even though representatives of parents, child health and nutrition experts, and even food companies all advocate for a single national standard. (To read the testimony or watch the hearing, click here.)

Such a standard would even the playing field for disadvantaged districts. It would allow food companies to develop products for a national market, which is why it’s supported by industry. Undeterred by the public and economic benefits, the school boards want each and every district to develop its own nutritional standards.

The reasons cited by the school boards are weak, and raise serious concerns about their ability to govern in the public interest.

First of all, the school boards ask to be excused from enforcing nutritional standards because they worry that parents will complain that school boards are “culturally incompetent” and that food companies will object when their favorite products are no longer sold by the school. Put aside the fact that parents and food companies are both supporting national nutritional standards. Can the school boards really be admitting that they don’t want to take the heat for enforcing rules requiring minimal nutritional value?

The school boards also claim they are concerned that a national standard regarding healthy food would trample on “the values of local communities.” Maybe some communities just value obesity, diabetes, and other nutrition-sensitive conditions more than others.

To hide behind the loaded code words of cultural sensitivity and local values is offensive to the vast majority of parents who are concerned about their children’s health and assume their schools are, too. It should not be news to school boards that obesity and diabetes are much more prevalent in minority and low-income communities, which makes healthy food in these communities’ schools an even more important priority.

Finally, school districts also believe a school district’s “financial capabilities” should affect nutritional standards. Does this mean America cannot afford to eliminate junk food from poor schools?

Noting that a study in Pennsylvania found that only 29 percent of school districts report that students have fewer opportunities for physical activity now than they did before Congress insisted on the creation of local “wellness councils” a decade ago, the school boards claim that national rules are unnecessary. Oddly, the school boards point to this as an example of the success of local decision-making, asking for further deference because “just” 3 in 10 districts have diminished time for students to exercise. One wonders whether the school boards actually think this is an encouraging record, or are assuming no one is listening to them.

In fact, one significant reason for the school boards’ opposition to national nutrition standards is that school districts promote the sale of junk as a source of revenue, which the school board lobbyist outlined in his testimony before Congress. Problem is, the whole country pays for this penny-wise, pound-foolish mentality through the prevalence of diabetes and other chronic health problems, which contribute to lower overall health, less productivity, and greater expenses for treatment rather than prevention.

Perhaps most discouraging, however, are school boards’ misunderstanding of their own self-interest. Healthy children are better students. If school boards were appropriately focused on raising student achievement, then they wouldn’t be fighting for anyone’s right to feed their students junk food.

If school boards want to maintain their place as the most local expression of democracy, then they should recognize when the national interest must trump parochial concerns. Otherwise, parents and policymakers should take such important decisions out of their hands.

Department of Education Secretary Arne Duncan didn’t have nutrition standards in mind when he called for the elimination of school boards, albeit indirectly, by encouraging cities to give control of the schools to their mayors. The National School Boards Association should help school boards choose the right healthy food for their districts, not protect school districts right to decide whether to sell and serve healthy food.

Ross Wiener is Senior Adviser at the Education Trust, a national non-profit organization advocating to close opportunity and achievement gaps in public education.

Drug industry advocates are quietly allying with some of their longtime critics pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.

President Barack Obama bolstered hopes for a breakup last Saturday when he named two public health specialists to the agency’s top positions and appointed an advisory group to reassess the nation’s decades-old food safety laws.

Drug executives see a chance to speed up drug approvals that have lagged amid a drought of new products, provided their regulator is no longer distracted by high-profile food-safety breakdowns.

Other ideas have also been floated in the past for the creation of an over-arching food safety agency. But if a split is in the works, there have to be sufficient resources ready to tackle the problems FDA will still face, which include missing review deadlines on 20 percent of 2008 drug applications (according to the AP), a problem that could be compounded by workforce issues. As Virginia Cox points out in her chapter on FDA in Change for America: “Almost 50 percent of [FDA] managers and supervisors are eligible for retirement in the next five years.”

Salmonella bacteria was the weapon of choice. Colorless. Odorless. Invisible. “They think they are such royalty, those Americans,” the terrorists laughed. “Well they can spend all day and all night on their porcelain thrones!”

Okay. It didn’t happen that way. It was just a shoddy American peanut-processing company trying to maximize its profits from lousy legumes, filthy with fecal bacteria. But there is something distressing about the U.S. response to this home-grown catastrophe, which has now sickened 683 people in 46 states and forced the recall of about 3,500 food products.

More than two years after the Peanut Corporation of American began seeding Salmonella through the U.S. food supply—and more than two months after federal investigators proved consumers were getting ill from peanut products made in the the company’s Blakely, Georgia, processing plant—the number of cases continues to grow.

In addition to the more than 100 victims who were made so seriously ill that they had to be hospitalized, at least eight people have died from Peanutgate, according to figures from the Centers for Disease Control and Prevention. That’s more than the five who died as a result of the anthrax bioterror attacks of 2001. And yet, says a recent CDC posting: “The outbreak is continuing….”

Nowhere is the nation’s inability to rein in this epidemic more obvious than in the steady flow of alerts from the Food and Drug Administration that, day after day, comes into my e-mail box, announcing foods newly added to the list of recalled products. In the last three days of last week alone, I received notices about 11 companies recalling more than 17 different products because of the peanut recall (just see the sidebar to get an idea).

Shouldn’t we pretty much know by now which products are affected? What if this was a terror attack? Can’t we do better than this?

Granted, part of the problem is that earlier this year the FDA concluded that a second processing plant owned by the same company also sent out contaminated peanut products. So the list of affected distributors, retailers, and products grew, and a new wave of notifications got underway. Still, it’s been more than a month since that source was documented. And at least some of the most recent recalls relate to products produced back in Georgia, which—let’s face it—really should have been tracked and pulled from the market by now.

It hasn’t helped that the owners of Peanut Corp., consummate businessmen that they are, saw which side of their peanut-butter-smeared bread was going to fall face down, so promptly declared bankruptcy and bailed. They are legally responsible for contacting their various distributors. However, the company announced last month, “The firm’s assets are currently under the control of a bankruptcy trustee, which impacts the company’s ability to take any actions regarding recalled products ….” As though it was such a responsible company before it went into bankruptcy, but anyway.

These particulars notwithstanding (and as I have complained about before) the nation’s system for getting a handle on these kinds of outbreaks is clearly in need of a major overhaul. Thanks to bioterror legislation passed in 2002, food suppliers must have records showing from whom they got products and to whom they sold products—one step in each direction. But food supply chains often contain several middleman-distributors, so the notification process slowly bumps along, one link at a time.

I called several retailers last week who had become caught up in the recall. One told me that she got a call from her distributor asking to whom he should send an important letter about an issue he didn’t want to mention on the phone. She said, “It’s me. Just tell me what’s up.” But he insisted on sending a letter, which arrived three days later, telling her that some of the food he had shipped previously needed to be recalled.

“I called back, furious,” she told me. “I told him, ‘I’ve been selling this for three days when I could have pulled it!’”

As I learned from my calls, many of these operations are small; although they have computers, their shipping records are often paper invoices, stored in boxes; they have neither legal staffs to interpret their responsibilities nor spare workers to thumb through stacks of invoices to compare lot numbers and production codes and to figure out which batches have sold and which may still be in their storerooms or warehouses.

“It’s ludicrous to trace back through paper records,” Mike Taylor, a former FDA deputy commissioner, told me last week. Yet that is what stitches the U.S. food sales network together. And though several bills recently introduced into Congress make tippy-toe steps toward insisting upon better, computerized tracking systems, none really takes the tiger by the tail (to mix a few anatomical metaphors).

Most of these companies also have no idea how to handle a recall, which under federal law is their responsibility, not the FDA’s. And guess what? There is no time limit under the law stipulating the number of days a company can take to alert consumers about contaminated products. So most of those I spoke to just waited until an FDA employee could find the time to get to their doorstep and, in person, walk them through the process.

Meanwhile the stuff keeps getting sold, and more people get sick.

The real kicker here is that, by the time any of this happens, most of this food is long gone and long eaten. Many of the notices last week were for trail mix and other snacks sold last fall. Some of the recalled foods were distributed as far back as 2007. It’s enough to make you wonder whether this whole, hugely expensive recall process is more a federally sponsored ass-covering process than an actual strategy for promoting the public health.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Organics has grown from an $11 billion business in the United States in 2001 to one that now generates more than $20 billion in sales, so the stakes for farmers, processors and certifiers can be high. But the agency overseeing the certifying process has long been considered underfunded and understaffed. Critics have called the system dysfunctional.

SP contributor Nancy Scola traced some of the fishy organic certification systems across the Pacific to China in her article this week, and covered the broader problems of a fractured food safety system last year. She noted that: “The GAO, which has long called for a single food agency, last year bumped the current system up to the level of ‘high-risk area.’” That “last year” was 2007. The new appointees in the Obama administration have their work cut out for them and will need sustained resources to make sure all food, organic or not, remains safe.

Over the course of the current Salmonella Typhimurium outbreak, the Centers for Disease Control has so far cataloged 677 cases in 45 states. Here’s the latest from the CDC as of Sunday:

The contaminated peanut products originated from a plant in Blakely, Georgia, but the shipping routes for those items have likely determined the geographic distribution of sick citizens.

For more on that, and a comparison with last year’s national food safety disaster, which involved Salmonella Saintpaul hitching a ride on tomatoes, see this post by Emily Sciarillo at FortiusOne’s “Off the Map” blog (HT to Nancy).

Many of us are Lunas when it comes to organic. That a rogue Georgia peanut plant might allow salmonella into organic snack foods from, perhaps, Chinese peanuts, probably strikes many of us as a long way from that idealistic post-Silent Spring 1960’s vision of a people-powered sustainable alternative lifestyle. (Even more so when we consider that while the source or sources of the current outbreak haven’t been nailed down, the debilitating bacteria could have come from a peanut crop that was certified organic by direction of the Chinese government and was, perhaps, grown in raw sewage—but more on that in a bit.) For better or for worse, today “organic” is part of America’s conventional food system, dependent on the same processors, distributors, and marketers as nearly everything else we eat. And so, when the American conventional food system sneezes, organics catch a cold.

Tracing the Salmonella Outbreak

The Georgia-based Peanut Corporation of America, or PCA, has long been a source of ills. One peanut buyer complained to the Washington Post that PCA preyed on “distressed situations,” finding big paydays with suppliers who “had peanuts from last year that had to move.” In a November 2006 letter recently uncovered by Congress, a consultant wrote PCA CEO Stuart Parnell to explain where an outbreak of salmonella was likely coming from. “Organic Chinese peanuts were the source of the roasted, granulated peanut product,” wrote Darlene Corwart of J. Leek Associates, Inc., who didn’t respond to Science Progress’ request for comment. She went on: “[I]t seems likely that the Chinese Organic peanuts could be the source for the microbial hazards given the nature of fertilizers used on organic products.”

If your ewww sensor goes off at the mention of “the nature of fertilizers,” that’s with good reason. It’s a good bet Corwart is referring to the practice of using untreated excrement—animal and otherwise—to fertilize Chinese crops. (If I haven’t already lost you to queasiness, the Dallas Morning News has more on the practice.)

Organic: Adrift in USDA’s Backwater

But there’s a check, right? Some responsible party making sure organic stands for something? Well, it depends. Organic became a federal standard two decades ago when farmers needed something for customers to trust beyond their smiling faces; in effect, the U.S. Department of Agriculture is vouching for the conscientious farmer. But, explains Pennsylvania Certified Organic’s Emily Brown Rosen to Science Progress, housed within the USDA’s Agricultural Marketing Service, the National Organic Program, or NOP, has never been much liked. The USDA approach to organics, say even supporters of the current system, has long been like dragging your kid brother or sister out with your friends because mom said you didn’t have a choice. “USDA didn’t start the organic process because they wanted to,” said Rosen. “They started the organic process because the organics community got a bill passed on the floor of Congress,” the 1990 Organic Foods Production Act, or OFPA. Rosen describes NOP’s status at USDA as “very sort of backwater.”

Keep talking to Rosen, and the conflict between how parents like “Luna,” growers, and the USDA all see organics jumps out. “Most people involved in organic think it is a high-quality product,” she argues, “But USDA makes a big deal out of saying that organic isn’t a food safety claim or a quality rule—it’s a marketing standard.” NOP refers to itself as “a marketing program housed within the USDA Agricultural Marketing Service.” That’s “marketing” twice, for those of you counting at home.

The Dawn of Cheap Organics

Yet while making its home in bureaucratic Siberia, the “organic” label has also morphed from community standard to a U.S.-backed magical stamp of approval, as good as currency. The organic market is, after all, booming. Sales grew from $1 billion in 199o to $20 billion in 2008, and are pegged to grow 18 percent each year for the near future. CLIF Bar—whose idea of branching out means a LUNA bar line for women—found itself caught up in the PCA recall. The other organics on the list, though, are products of far bigger businesses. Health Valley Organic Peanut Crunch Chewy Granola Bars are a product of the billion-dollar food giant Hain Celestial Group. Organic Cascade Trail Mix belongs to the discount grocery store chain WinCo. Cascadian Farms, makers of the recalled Sweet & Salty Mixed Nuts Chewy Granola Bars, is a General Mills brand. Today’s iconic organic brand is less Farmer Jane’s farm-grown apples than Anheuser-Busch Organic Wild Hops Lager.

Jim Riddle served on USDA’s National Organic Safety Board for five years. “A shopper still needs to be smart in their food choices,” Riddle advises. “You can waste your money on highly advertised and packaged and marketed products organic products just like you can waste your money on highly advertised and packaged and marketed conventional products.”

Into the Peanut Breach, China

With the growing hunger for mass-market organics, the U.S. needs China’s organic peanuts, and cheap. Take it from the Chilean American Chamber of Commerce. “With increasing popularity of organic products due to changing preferences, lower prices and the entrance Wal-Mart into the market,” AmCham Chile has told its farmers and producers, “dependence on imports will only get larger until the US organic agriculture system changes.” All this creates the (unrealistic?) expectation that organic should be easy on the wallet. “It trickles down to the budget-minded shopper,” argues Organic Consumers Association chief scientist Craig Minowa. “You go into the store and see an organic peanut butter that’s three dollars more than another organic peanut butter sitting next to it on the shelf. They go cheaper. But what they won’t do is flip over the jar and see that the peanuts were grown in China.”

PCA’s Blakely, Georgia plant was smack in the middle peanut country. (Jimmy Carter’s Plains farm is about 75 miles northeast.) But, plagued by weeds, few local peanut farmers are certified organic. Yet, admits Riddle, when it comes to outsourcing organics to China, “There are problems.” While Whole Foods may say that “organic standards in China are no different than they are in Brazil, Turkey, Thailand or anywhere else,” Riddle concedes that “not all organic is the same.”

Translating “Organic” Abroad

Still, there’s an expectation that USDA organic, even on Chinese peanuts, means something. Worth keeping in mind is the fact that USDA doesn’t actually certify any carrot or potato or apple as organic. It certifies certifiers. NOP’s tiny staff of 15 relies on third party accreditation agencies—Quality Assurance International, for example, or the Organic Crop Improvement Association, which, according to an archive of the PCA website, was the certifying authority on its troubled Georgia plant. “The certifiers realize that the more products they certify, the better it is for them,” explains Minowa. “So you might have an inspector coming in who might have a boss who says ‘you don’t need to be so anal about it.’” (The organic certifier in PCA’s Plainview, Texas, plant has since been fired by the Texas Department of Agriculture.)

Or you might have a foreign government with an unsettling food record. Consider this: with imported foods, USDA relies on certifiers working in-country, but Chinese regulations prevent foreign inspectors on Chinese farms. So, a third-party certifier like OCIA, for example, operates a local office at 8 Jiangwangmiao Street in Nanjing, in eastern China’s Jiangsu province. But that office is actually run by China’s Organic Food Development Center. Which is, in fact, an arm of SEPA, or, China’s State Environmental Protection Administration. As in, your peanut butter’s organic because the Chinese government says it is.

OCIA CEO Jeff Sees defends the arrangement in an email: “Certification Decisions are not made by OFDC. All inspection reports are given to our staff in China who translate the reports and send them to our reviewers in Lincoln [Nebraska] for the determination of Organic status.”

The Fix? An Empowered USDA Organics Program, Demanding Eaters

Thanks to the 2008 Farm Bill, funding of the “backwater” National Organic Program got a small bump for fiscal year 2008, and President Obama’s FY2010 budget overview released last week pledged a boost in USDA organic funding dedicated, in part, to “maintain[ing] label credibility.” Still, the office overseeing a $20 billion industry is running today on, at most, just $2.6 million a year. A more empowered organics program at USDA could poke its fingers into more places, including in problem spots abroad like China. As the organic boom continues, concerned eaters like Luna and the rest of us have to demand that the “USDA organic” label means something real, powerful, and bankable. After all, with the American food system we have today, “organic” eaters or not, we’re all eating from the same pie.

Nancy Scola is a writer in Brooklyn, NY.

If that seems quick to you (how could a company pass muster just a few weeks after the ground rules were released?) you are right. In fact, by approving the drug without having at least one public meeting devoted to important environmental, animal welfare, and other issues, the agency broke its own promises of how such approvals will be handled. Word on the street was that Atryn’s maker was in need of a positive nod from the FDA to help it get some investor dollars. Well, we wish the company well. But we also hope that the agency gets back on its own track with future applications, which are anticipated to encompass not only medicines made in animals but also gene-altered animals that themselves will be marketed for human consumption.

Image: flickr.com/jb1

Yesterday, officials from the FDA and the Centers for Disease Control and Prevention announced an expanded nationwide recall of products made from peanuts processed at the Georgia plant to include ingredients released as far back as January 2007. That expansion-which makes this recall one of the biggest in U.S. history-made sense, they said, as it has become clear that the company repeatedly failed to keep products off the market despite their having tested positive on several occasions for Salmonella, a bacteria that can cause food poisoning.

The toll to date: 501 people known to have been sickened in 43 states and in Canada. Of those, 108 hospitalized. And eight people so far believed to have died from having eaten the tainted products. All of the deaths have been people 59 years old or older. But fully half of the known cases of illness have been in children 16 years old or younger-a reflection of the prevalence of peanut butter and concentrated peanut paste in snack foods.

FDA and CDC are asking the right questions of the folks at Peanut Corp. And before long, so will lawyers for the victims. But there are equally important questions that independent investigators need to ask FDA and CDC, among them:

• How is it that a company’s internal testing can repeatedly come up positive for a disease-causing microbe and yet that company can have no obligation to report those findings to anyone, ever-not even the FDA or state health officials when they come around periodically to see how things are going?
• When the FDA subcontracts to state health departments its responsibility to inspect food processing plants, as it often does because of federal manpower shortages, how does the agency validate the professionalism and accuracy of those contracting departments?
• Might there be a need to clarify, either in the regs or through legislation, a company’s responsibility to act on initial test results that indicate contamination-that is, to keep those products off the market-as opposed to retesting (as Peanut Corp. repeatedly did) until a negative result is obtained?
• At what point are current FDA requirements that the agency keep sensitive information about companies confidential counterproductive to good manufacturing practices and to the public’s legitimate right to know?

As PeanutGate and the financial meltdown both exemplify, the regulatory philosophy in this country has historically been one that relies on the foxes to out themselves when they’ve indulged in malfeasance. Sure, everyone knows that too much oversight can stifle the flexibility that is key to ingenuity and innovation. But the pendulum has swung awfully far. Do we really have to wait until the fox gets caught with blood on its claws-and tainted peanut butter in its teeth-before we consumers get to find out what’s going on behind closed doors?

Image: flickr.com/dberlind

Okay, so according to the Lyndsey Layton in today’s Washington Post, the FDA has issued clear information that major brands of jarred peanut butter on grocery shelves are not subject to the recall. But there are hundreds of products affected–so many that the FDA has set up a database to track them all. If you want to stay on top of future recalls, the agency actually has a dedicated Twitter feed. (Science Progress is following.)

This is all the result of Salmonella in one Georgia plant. As Rick Weiss pointed out in his Monday column, it’s “a vivid example of our intensively centralized food production and distribution system.”

Cartoon: Mike Luckovich, Atlanta Journal-Constitution. From the Cartoonist Group.

As of last week, about 500 people were known to have been seriously sickened by eating Salmonella-tainted peanut paste (and in some cases, peanut butter), all of it produced during the past few months at a single Peanut Corporation of America plant in Blakely, Georgia. What’s impressive about this outbreak is that those victims are dispersed among 43 states, and they collectively got their illnesses from having eaten one or more of 135 or so different products, all of which contained peanut paste or peanut butter from the same Peanut Corp. plant.

What a vivid example of our intensively centralized food production and distribution system! A small-town Georgia processing plant, soiled with fecal bacteria from an unknown source, sickens hundreds of consumers across the country-and probably thousands more who wrote off their bouts of diarrhea and vomiting as one of those “facts of life” and so went untallied by health authorities.

The most mundane truth behind these events is that the agencies we depend on to oversee food safety in this country are underfinanced and understaffed.

This is but the latest in a string of tainted food scandals that have gripped the nation in the past couple of years, including ones involving toxic melamine in pet food and baby formula and Salmonella in peanut butter and on sprouts, spinach, tomatoes, and peppers. What to make of it all?

The most mundane truth behind these events is that the agencies we depend on to oversee food safety in this country are underfinanced and understaffed. As documented in Change for America, the progressive blueprint recently released by the Center for American Progress Action Fund, those responsibilities fall mostly on the Agriculture Department and the Food and Drug Administration-but primarily the FDA, even though it enjoys a far smaller food-related budget than does USDA.

Years of stale budgets for the chronically cash-strapped agency have led to the departure of about 1,000 FDA scientists in the past few years, even as Congress enacted about 125 statutes that demand additional agency resources. Nearly half of the FDA’s managers and supervisors are old enough to retire within the next five years. And staffing at the agency’s Center for Food Safety has declined 20 percent over the past three years. A new food protection plan, released more than a year ago, remains unfunded.

It would be naive to believe that these realities did not contribute to the fact that, either unnoticed or undaunted by federal or state overseers, Peanut Corp. has apparently been producing Salmonella-tainted products since July 2008, according to a Centers for Disease Control and Prevention retrospective, still being constructed by government epidemiologists. It’s still not clear who, if anyone, was aware of that problem back then. The FDA inspected the plant last year and found failings, but details have not been disclosed. Months later Georgia state authorities inspected it again at FDA’s request. What triggered that request, and exactly what was found, is still a secret.

Beyond the fact that the nation’s food-plant inspection and follow-up process is not sufficiently aggressive, the peanut-paste outbreak has brought other shortcomings into focus.

For one, the FDA still lacks the legal authority to recall tainted foods, despite repeated calls for Congress to grant this important power. Instead FDA must cajole offending companies, and allow them to arrange such actions on their own terms, which often means slowly and one product at a time even as overwhelming evidence of trouble accumulates. Delays can matter: at least six people are so far suspected of having been killed by the bacteria in this outbreak.

Equally troubling is what the FDA and CDC have had to go through to figure out where tainted paste may have been shipped and which products it ended up in. I am on an FDA listserve that alerts subscribers every time a food is recalled, and the pace of Peanut Paste-gate has been enlightening.

On January 17th, for example, it was Kellogg recalling its peanut butter sandwich crackers and Famous Amos and Keebler Soft Batch Peanut Butter Cookies; Hy-Vee Inc. recalling its Monster and Reese’s Pieces cookies and its People Chow Party Mix and Assorted Truffle Fudge; and Perry’s Ice Cream Co. recalling its Select Peanut Butter Ice Cream. On January 18th McKee Foods recalled its Little Debbie Peanut Butter Toasty and Peanut Butter Cheese Sandwich Crackers, and South Bend Chocolate Co. recalled some of its candies. On the 19th it was Kroger Select Ice Cream Products; various ZonePerfect health and energy bars; and cookies made under the Wal-Mart, Food Lion, Lofthouse, Chuck’s, Meijer’s and Pastries Plus brands (not to mention a recall of “uneviscerated mackerel fish,” apparently unrelated, though who knows what was going on in the back rooms of that Blakely peanut processing facility?).

Day after day the news has continued to trickle out, like a bad case of the runs (egads, not the PetSmart “Great Choice” Dog Biscuits too!). The problem is that Peanut Corp. and federal and state regulators have had to shuffle through countless invoices going back many months, and each suspect company has had to confirm that information using its own (often incompatible) computer and bookkeeping system. Isn’t it time for a unified, interoperable software program for use by all FDA-regulated entities that would allow this kind of information to be called up quickly by health authorities in situations such as this? Wouldn’t that be useful if some bioterrorist were to slip a nasty bug into a distribution hub for baby carrots or hamburger patties or bottled water?

While we’re at it, might it be time to take seriously what so many expert groups (and some in Congress) have been saying for a long time, namely that food safety is too important to be a stepchild of an agency that is primarily concerned with the pharmaceutical industry? Let’s face it: The current system is nuts.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

As my brother-in-law and I gazed upon the enormous, picture-perfect turkey glistening golden-brown on his cutting board last Thursday, we had the same thought—and blurted it out in near-unison: It looks just like the fake turkey that President George Bush delivered to the troops during that photo-op in Baghdad a few years ago!

Indeed, the big-breasted bird on his kitchen counter was too plump, too perfectly muscled, too marvelous to be true. And as I recalled some of what I’d learned over the years about how the once-wild American turkey came to be the magnificently mutated mass of meat that it is today, I couldn’t help but also think again about the Food and Drug Administration’s pending decision on whether to allow the marketing of foods from gene-altered farm animals.

Turkeys are not made by genetic engineering—not yet, at least. But no one can look at the modern Butterball (or, for that matter, the Amish-market free-range Amazon that my brother-in-law broasted) without facing the fact that the animals we eat today have little in common with their wild predecessors. It’s an argument that proponents of gene-altered food have made repeatedly, and one that is especially difficult to ignore on Thanksgiving: Whether by DNA manipulation or old-fashioned selective breeding, we engineer our food. Get over it.

As I’ve written before, I don’t fully buy it. But to be fair, let’s consider the turkey’s trajectory from sinewy forest fowl to succulent urban uber-bird.
The turkeys of Pilgrim’s pride were bigger than the average avian entrée of the day and so popular for special occasions, but they were small and scrawny by today’s standards. The modern turkey was not born until the 1940s, when scientists in Beltsville, Maryland, used conventional breeding to begat a definitively better bird—one whose feathers were white instead of the traditional camouflage green and brown. That took care of a longstanding aesthetic issue. When turkeys with colored feathers got processed, it turns out, the leftover roots and pigments from those feathers gave the meat a five-o’clock shadow. Understandably, that didn’t sit well with consumers.

The advent of the Beltsville White helped launch a major market for turkey meat, which in turn led to a big push for faster growth and bigger birds. Through a series of intensive breeding efforts that began in earnest in the 1980s, turkeys in the 1990s were achieving weights of about 35 pounds in as little as 20 weeks—a 40 percent improvement in heft compared to a decade earlier. Of course, that’s a trend we’ve seen in humans, too. But in this case we’re not talking about an obesity epidemic. The new birds have extremely efficient metabolisms that quickly convert feed into meat and not fat.

Today, more than a quarter of a turkey’s body weight is muscle, and most of that is breast, to satisfy U.S. consumers’ preference for white meat. The bones are oriented and muscled in ways that allow the birds to remain upright despite their teetering, cantilevered, Dolly Parton-ish proportions.

There was a price to pay, of course—for the turkey, that is. The birds’ internal organs are crammed together in what little space remains in the body cavity, which may help explain why the lifespan of a modern turkey is a fraction of what it used to be, even if it is lucky enough to get a Sarah Palin pardon. And sex is all but physically impossible, which is why virtually every turkey raised in this country today is conceived by means of artificial insemination. (I once met, in Beltsville, the guy whose job it was to get many of the semen samples used in this process. He did so by hand, using a technique that he referred to as “abdominal massage.” Suffice it to say that he did not have to call to the turkeys when he walked into a pen.)

My point is that this massive reengineering of the turkey by old-fashioned breeding is clearly more substantive than any of the changes that we might expect to occur through the insertion of a mere gene or two into a few members of the modern barnyard menagerie, such as the Aqua Bounty farmed salmon (gene-altered to make them grow faster) or the Canadian Enviropigs (gene-altered to make their manure more environmental friendly). So it is understandable, perhaps, that the FDA has taken a stance favoring the marketing of milk and meat from gene-altered animals, at least once they have passed some basic tests for safety.

The agency accepted public comments on the issue until just before Thanksgiving (virtually all of which, visible here, were negative, though for the most part not carefully reasoned), and a final decision is expected soon.

As the agency digests consumer sentiments and weighs them against the economic interests anxious to get their altered animals to market, let me just remind regulators and other readers of a few facts that should temper any decision to commercialize these critters too quickly.

1. Breeding happens slowly. Genetic combinations that result from sexual recombination and that don’t work well tend to get weeded out over time and are unlikely to get to a consumer’s mouth. That safety margin can be compromised when genes are crammed into massive numbers of creatures that are then sent on the fast-track to grocery shelves.
2. Genes can behave differently in foreign species than they do in their home turf. An experiment a few years ago involved the transfer of an ordinary gene from a bean into a pea plant. In the bean, the gene coded for the production of an ordinary, non-allergenic protein. In the foreign genomic environment of the pea plant, however, the innocuous bean protein attracted a coating of other molecules that made the protein potentially dangerous to people with certain food allergies. Such unexpected results in cross-species recombinant DNA experiments undermine the idea that genetic engineering is just like regular breeding but more precise.
3. Eating is intimate. People have emotional relationships to food. Even if the health risks to consumers and the animals themselves are low, producers and regulators would be wise to open the new agricultural approach to some degree of public inspection as a way of fostering all-important consumer trust. In other words, make the approval process more transparent than what the FDA has proposed so far.
4. Remember our far-flung food importers. Even if we in the United States decide we are okay with food from engineered animals, our trading partners around the world may not be. In fact, history has shown many of them to be more than a little queasy on this topic. Whatever cost savings may be had from a faster-growing salmon must be weighed against the potential losses in confidence and, ultimately, sales, caused by our move into what others might see as the realm of phony food.

There is an important future for engineered animals as sources of food, medicines, plastics, high-tech fibers and perhaps even organs for transplantation into people—all applications researchers are now pursuing in an array of U.S. labs. But if companies insist on working through an FDA approval process that, as currently proposed, would allow essential details to be kept under wraps forever as “confidential business information,” then they shouldn’t be surprised if they are lambasted as, well, turkeys.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Juan Lazaro IV/IRRI Photo Bank

A comparison of different rice types.

From the NSF, a story on a federally-supported project aimed at harnessing the power of distributed computing to alleviate hunger.

The project, dubbed Nutritious Rice for the World, runs out of the University of Washington, but pieces of the research could be unfolding on a desktop near you. That’s because the research is one of five projects currently part of IBM’s World Community Grid. The grid allows volunteer computer users to run a small program that takes advantage of unused processing power to predict the structure of desirable rice proteins.

Understanding the protein structures for the major strains of rice will allow researchers to help farmers cultivate healthier crops, feeding more people and earning growers more income from their harvests. According to the Food and Agricultural Organization of the United Nations, rice is the primary staple food for more than half the people on the planet and accounts for 20 percent of the total caloric intake of everyone in the world.

Ram Samudrala, associate professor and computational biologist, is the project leader at UW, and explains that plants better suited to local environments mean that food doesn’t have to move across large distances before it get to the people need it:

“The fundamental problem with food shortages in the world is one of distribution,” Samudrala says. “Creating distribution chains costs money. We overcome that by designing new crop species that indirectly address this problem by providing higher yields but also better nutrition and adaptability to local and global environments.”

This is doubly significant in the wake of this year’s food price spikes and the resulting crisis. One of the catalysts of the price increases was the skyrocketing cost of transportation fuel.

Press coverage of the project has been significant since the launch in May of this year. Got some unused CPU power under the hood of your PC? Anyone can register for the grid.

Christopher Doering of Reuters reported Tuesday that the “FDA and USDA have said it is impossible to differentiate between cloned animals, their offspring and conventionally bred animals, making it difficult to know if offspring are in the food supply.”

AP/Jason Turner

Offspring of cloned dairy cows.

In January, the FDA released a report giving two thumbs up on products from cloned cows, pigs and goats (the FDA didn’t make a recommendation on sheep because there wasn’t enough information), stating in a 968-page “final risk assessment” that food from cloned versions of these animals doesn’t pose any harmful health risks. The milk and meat from cattle was deemed safe, as well as meat from pigs and goats. The day after the FDA report was released, the USDA requested that U.S. farmers not sell food products from cloned animals, citing a need to first harmonize rules with trading partners and to build acceptance.

Consumers in many countries, including in the United States, have said they oppose food from clones or their offspring because of health and safety issues and because of concerns for the health of the clones themselves. Ethical issues are also being considered by the European Food Safety Authority, which is funded by the European Union to provide risk assessments on food. It’s their opinion that “considering the current level of suffering and health problems of surrogate dams and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified.”

Center for American Progress Senior Fellow Rick Weiss, who was then a staff writer at the The Washington Post, reported in January the FDA doesn’t require food companies to label products containing cloned livestock. But the agency may allow other companies to label products that do not contain cloned meat or milk.

In May, Nancy Scola reported in Science Progress on the disarray of the federal food safety system. With several recent food recalls and government agencies constantly placing blame on one another, Scola wrote that the food safety system is so complicated it “verges on the absurd.”

“When we had the spinach episode, everyone acted like it was a great surprise,” former FDA Commissioner Lester Crawford, a Bush-appointee and long-time federal food safety official, told Scola, “But the likelihood of something bad happening [with the food supply] is always quite high.”

The number of cloned animals in the country is low—only around 600, with cattle being the majority—but offspring are unaccounted for, and the size of the second generation is unknowable, especially since a single male clone can sire countless offspring through mail-order semen sales. Indeed, clones are too expensive to slaughter for the meat market, so for most farmers the business plan is to use them to breed high-quality offspring. Alex Seitz-Wald of NewsHour Extra says one breeder in Kansas has been selling his cloned cattle’s sperm for years. According to Seitz-Ward, cattle experts believe that food products from the offspring of clones already exist in the American food supply.

AP

Executives from Hormel Foods Corporation and Cargill, Inc. testify before Congress on food safety in November 2007.

Previously, “downer” cows were deemed fit or unfit for slaughter on a case-by-case basis. But concern over the safety of the beef supply peaked earlier this year when the USDA issued the largest meat recall in history of 143 million pounds. A congressional hearing following the recall raised serious questions about both the ability of the USDA to keep food-borne pathogens out of the food supply, and the problem of overlapping jurisdiction between the Food and Drug Administration, the Centers for Disease Control, and the USDA.

In this instance, oversight responsibility seems clear and it’s a good thing that the USDA is aiming to close this loophole through which E. coli, salmonella and other such nasties can slip (UPDATE: see testimony from the February hearing by Michael Greger, M.D.). But the proposed rule highlights the broader problem of trifurcated food regulation. Writing in Science Progress about “Our Fractured Food Safety System,” Nancy Scola reported recently that, “The GAO, which has long called for a single food agency, last year bumped the current system up to the level of ‘high-risk area.’” She goes on to describe internal conflicts at USDA:

Its primary role in Washington is to promote the food trade—to boost the amount of American pork the Chinese eat, not to worry over whether the pork Americans consume is safe to eat. GAO recently profiled seven countries (Canada, Denmark, Germany, Ireland, the Netherlands, New Zealand and the United Kingdom) that have consolidated food oversight under one roof. Most interesting is the holistic farm-to-fork approach of EU member countries. Ireland is a typical case, moving its food safety agency under the auspices of its existing public health authority—in recognition of the fact that the raison d’etre of their own Department of Agriculture is promotion, not policing.

Keeping sick cows out of the food supply is a good start, but rationalizing food safety will take more than just rulemaking. The comment period on the USDA rule extends until September 29. More info here.

Great Britain, which put a blanket ban on all GM crops in 2004, is now beginning to grant new applications for field trials of bioengineered crops, and British scientists are pushing for allowances to conduct even more GM research. A policy shift among European Union member states would be particularly significant, as most of the global food trade is affected, directly or indirectly, by European regulations. An EU move towards acceptance of GM foods would undoubtedly inundate global markets with bioengineered crops, much to the chagrin of the many protesters in both the United States and abroad.

AP

Scientists can engineer seeds that are drought resistant, can withstand harsh chemicals, or that contain extra vitamins.

The debate about the safety of GM foods isn’t going to end any time soon, in Europe or the United States. Here at home, though, debate over the benefits and potential pitfalls of the technology must be framed around the fact that engineered seeds have to pass through the screening procedures of three different agencies, a more rigorous testing procedure than any other food undergoes.

In 1986, the United States established the Coordinated Framework for Regulation of Biotechnology, which describes what safety requirements each agency is accountable for monitoring and the intricate detail in which the agencies must work together. The U.S. Department of Agriculture evaluates the seed’s agricultural safety, while the Environmental Protection Agency assesses hazards the new crop might hold for the environment. The Food and Drug Administration ensures that the crop (with its newly engineered protein falling into the “food additive” category) is safe to eat.

While this battery of evaluations is by no means foolproof, it does ensure that genetically engineered foods that make it to our tables are at least as safe, by any testable standard, as other foods on the market. Critics of genetically modified crops, however, raise other issues. They point out that most of the genetically modified seeds that are sold are engineered to be resistant the high levels of pesticides or herbicides. This use of such technology only furthers the interests of the corporations who produce the seeds and, invariably, the chemicals for which they have resistance. It also encourages farmers to use a heavy hand when applying these toxic chemicals to their fields.

Others worry about the lack of definitive tests to ensure the safety of genetically modified foods. The concern is that the engineered crops could produce surprising toxins, or that the spliced-in DNA might escape the digestion process in our stomachs and fuse with our DNA or the DNA of our gut flora, causing mayhem. The list of concerns goes on, and every blog or news outlet will provide a different spin.

Certainly, there are issues to be addressed by policymakers. Foods containing GMOs are not currently labeled, and it is thought that as much as 70 percent of all processed foods on the shelves in American grocery stores contain GM ingredients. Some groups have suggested that there should be some system requiring labels for these products to enable consumers to make informed choices about their food purchases.

Before that could happen, though, there would need to be a better system for keeping engineered seeds from infiltrating organic crops. One of the biggest contentions farmers have with engineered seeds is their tendency, like any other seed, to drift. Many organic farmers have found high percentages (frequently over 20 percent) of their crops to be contaminated with GM seed. One solution might be to establish GMO-free zones, like those in place in California, to allow organic farmers to raise their crops without worry of contamination from nearby farms.

While U.S. farmers, the media, concerned parents, and all the other interest groups continue to go back and forth on this issue, there is a global dimension to the debate that policymakers must also weigh. In small areas of Africa, farmers have introduced seeds engineered to increase the crop yield and the nutrition of those yields. These crops can be a huge source of relief in parts of the developing world where malnutrition affects over 800 million people, a number that will only continue to increase with the rapidly growing global population and the skyrocketing costs of food.

Plants that are engineered to have higher levels of essential vitamins or nutrients help children develop properly and help adults keep their immune systems healthy. Crops engineered to be drought resistant or have higher yields can help stem the global food shortage while bringing much needed income to poor farmers. The first step in any long-term solution to the food crisis is to increase the self-sufficiency of starving populations. This can be partially accomplished by giving farmers access to improved seeds.

At the heart of the matter, the debate over genetically modified crops is really two separate issues. Much of the genetic engineering done on crops in the United States improves the crops’ ability to withstand powerful chemicals. The genetic engineering that could contribute to the malnourishment problem in the developing world improves crops’ ability to feed people. Thus the debate over GMO foods should be conducted as two debates.

The first: whether chemical companies are using biotechnology to sell more of their product and maintain a stronghold on seed technologies and thus agricultural production. And the second: whether supporting the use of biotechnology is an appropriate means to help solve an urgent humanitarian problem that will continue to grow if the global community doesn’t act aggressively. After all, the majority of processed foods in the United States contain some genetically modified ingredients that over the past two decades have not resulted in any immediate adverse health effects, but malnutrition kills ten million people a year. The seeds of this biotechnology have already been sown; it is now our responsibility to make sure we utilize them for good.

Bob Dinneen, CEO and President of of the Renewable Fuels Association testified that ethanol production has a very small effect on food prices, and may actual be keeping them down. He told committee members that corn growers heeded the market signal sent by the RFS mandate last year, producing an additional 2.5 billion bushels of corn over the previous year’s yield, of which only 600 million bushels went towards producing ethanol. Thus, he argued, there was actually an increase in available corn.

Dinneen followed up by citing research which shows that only two percent of the world supply of corn is used goes into ethanol production and that only three percent of food price increases was attributable to that production. He said the main driver of increased food prices was the price of oil. Removing the RFS, he said, would only increase the price of energy, driving up food prices even further.

Rick Tolman, CEO of the National Corn Growers Association backed up Dinneen’s claim, explaining that the main culprit of increased food prices is the price of oil, which plays a significant role in each part of the food production chain. Tolman cited a recent study suggesting that a $1-per-gallon increase in the price of gas has three times the impact on food prices than a $1-per-bushel increase in the price of corn. He also testified that only 19 cents of each consumer dollar in the United States can be attributed to farm products such as grain, oil seeds, and meat. Labor costs 38 cents, and transportation, packaging, energy, and other costs make up the remaining 43 cents. He cited USDA economist Ephraim Liebtag, who calculates that a 50 percent increase in corn prices would translate to an increase in retail food prices of less than one percent.

Don’t remove the mandates, but don’t increase them either was the recommendation from Scott Faber, Vice President of Federal Affairs for the Grocery Manufacturers Association. He acknowledged that many factors are involved in the recent spike, “including increasing global food demand, export and other restrictions, adverse weather in some countries, commodity speculation, and higher energy prices.” He said that the one factor that is under the control of Congress is the package of “mandates and subsidies diverting food into fuel production.” Congress should be mindful, he said, that rising food prices are a significant challenge to the poorest twenty percent of Americans who spend about one-third of their after-tax income on food.

The food price spike has also pushed millions of people around the world in to poverty, he said, forcing food aid programs to ration their supplies. He asked Congress to revisit the mandate schedule; to push harder for second- and third- generation biofuels; and to increase support of international food programs and agricultural development.

Fortunately, there is a sufficient supply of biofuel feedstocks that do not compete with food crops: see “Alternative Cellulosic Biomass By the Numbers.”

Amid growing controversy, Subcommittee On Energy and Air Quality Chairman Rick Boucher (D-VA) called the hearing to revisit the RFS just five months after Congress increased the mandate as part of the Energy Independence and Security Act of 2007 which passed at the end of last year. The polarized hearing left committee members with a wide array of considerations to mull over as they decide the fate of the RFS in the coming months. To make sense of it all, Science Progress breaks down the hearing to discuss its varying themes. First up, what’s right with the RFS and ways to make it better.

The hearing opened up with testimony from Rep. Stephanie Herseth Sandlin (D-SD) who introduced her bill, H.R. 5236, better known as the Renewable Biomass Facilitation Act. The bill intends to expand the RFS to allow woody biomass collected from both federal and private forests to be used in the production of biofuel that would count towards the RFS. Woody biomass—the byproducts of forest management practices—are usually burned or left to rot, releasing carbon and methane into the atmosphere and could be put to better use as feedstock for biofuels, she argued. Most committee members used their allotted time to heap congratulations on Rep. Sandlin and pledge support for her bill. Using residual agricultural and forestry biomass as biofuel feedstock would avoid competition with food crops.

Committee members then heard from Robert Meyers, associate assistant administrator at the EPA’s Office of Air and Radiation who touted the President’s proposed Alternative Fuel Standard, which would replace the RFS in 2010. The AFS would include alternative, but non-renewable fuels such as natural gas and coal-to-liquid (which is a boondoggle), hydrogen, and plug-in hybrids, in addition to those renewable fuels already included in the RFS. While the AFS ups the required amount of alternative fuels in the country’s fuel supply, it gives the EPA discretion to adjust or waive requirements to protect the economy or environment from any detrimental impacts of biofuel production. He also revealed that the EPA’s report on the environmental and health impacts of biofuels—requested by Congress in 2005—will be released in the coming weeks.

Nathanael Greene, a senior policy analyst at the National Resources Defense Council, praised the RFS for its forward-looking approach, but pressed Congress to ensure proper safeguards are in place to protect the environment and food prices. He commended the RFS for properly defining lifecycle greenhouse gas emissions for biofuels to include the entire production process, as well as land use changes, which can severely alter the effectiveness of biofuels in reducing GHG emissions. He noted how the RFS requires the vast majority of new biofuels derived from cellulosic biomass to reduce lifecycle GHG emissions by 60 percent, a step away from a “more is better” policy to a “better is better” policy.

Greene recommended that Congress push the EPA to study environmental consequences of biofuels to ensure that science drives policy, not politics. He asked Congress to adopt a cap-and-trade program as part of a comprehensive approach to reduce GHG emissions and to reform the current ethanol tax credit to be technology-neutral and performance-based. Such an approach would incentivize biofuel innovation and keep Congress from picking the winners and losers in the biofuel marketplace, he argued.

Humane Society spokesperson Michael Greger, M.D. said in his testimony to the hearing that the documented abuses are actually widespread in the industry. “This was not an aberration, the work of a few rogue employees,” he stated. Meat produced from sick cows, he said, is more likely to contain disease-causing E. coli, Salmonella, and other pathogens.

Referring to a USDA rule introduced in 2007, Greger said companies are taking advantage of a loophole which allows some downer cows to be butchered with the approval of on-site USDA inspectors. A number of Committee members and witnesses at the hearing agreed that the loophole creates a financial incentive to get USDA inspectors to approve downer cows. The video documentary indicated that companies have become adept at manipulating overworked inspectors. To respond to this problem, Greger asked the Committee to mandate a complete ban on the use of downer cows for food.

Greger also said that many current food safety laws and rules were written in the first half of the twentieth century when policy-makers did not have the benefits of current scientific knowledge. Because new food-borne diseases have emerged and become epidemic as recently as the 1980s, Greger recommended that the regulatory system should be revamped to account for state-of-the-art science. He also recommended more funding of epidemiological research to better understand how epidemics of food-borne illnesses emerge.

William Marler, a food safety trial lawyer for the Seattle law firm Marler Clark, also testified about regulatory inadequacies. The problem with the system of food safety regulations, said Marler, is that it depends on a “trifurcated” group of agencies. The FDA, USDA, and CDC fail to share information and “walk all over each other,” he said. The inefficacy of Federal regulations, and the illnesses caused by unsafe food, produce a high demand for civil litigation, which he called “a blunt instrument for change” that an overhauled regulatory system could render unnecessary. “It is time for businesses and consumers to simply make me irrelevant,” he said. He recommended that Congress should merge the USDA, FDA, and CDC; create a local, state, and national surveillance system; and encourage full disclosure and transparency on information pertaining to food recalls.

Image: Humane Society of the United States, via flickr.com/smiteme

In his State of the Union address, President Bush championed recent discoveries allowing researchers to “reprogram” adult skin cells to act like embryonic stem cells. “This breakthrough has the potential to move us beyond the divisive debates of the past,” he said. Not so fast, say some researchers, who do acknowledge the potential of induced pluripotent stem cells, but believe it is to still to early to close up shop on hES research. Science offers in-depth coverage of the state of play and quotes stem cell researcher George Daley, who says that, “Right now, we’re not certain that iPS cells are the absolute equivalent” of hES cells. There’s still a lot of work to be done with iPS cells; that process will likely take a long time; and for the time being, hES cells are the gold standard for understanding pluipotency. Science also mentions alternative methods of creating iPS cells and exposes the premature political clamoring for a hES cell research ban.

Finally in Science: perspectives on a report finding that continued climate change will likely lead to greater food insecurity around the world. The researchers, using crop models, found that increased temperatures, coupled with decreasing precipitation in semiarid regions will lead to reduced agricultural production and higher prices for food. The issue becomes increasingly complex when considering the potential for continued rising oil prices, the globalization of grain markets, increases in biofuel production, and changes in farming technology. Climate change will have a far more dramatic impact on poor farmers in tropical regions who may not have the agricultural technology to make up for changes in the ecosystem. Crop subsidies in developed nations that make competition difficult won’t help matters either.

Nature reports that Monsanto and Syngenta have withdrawn their support for the International Assessment of Agricultural Science and Technology. The $10 million project, which involves at least half a dozen transnational agencies including UNESCO and the UN’s Food and Agriculture Organization, aims to produce quality forecasting of global social, environmental, and technological changes related to agriculture. The companies reportedly were disappointed that the International Assessment placed a high degree of emphasis on risks of agricultural biotechnology, rather than on its benefits.

Meanwhile, The World Bank (another institution involved in the IAASTD project) has released a new report, “Technology Diffusion in the Developing World” (pdf), which indicates rapid technological progress in the developing world, but also indicates a need for developing nations to become more receptive to foreign technology. Alan Gelb, chief economist at The World Bank, commented that “governments may need to intervene directly to encourage the rapid diffusion of technology and a domestic culture of ‘new-to-the-market’ innovation.” Presently, the report says, technical illiteracy and poor business climates stifle the “absorption” of new techniques and ideas (via SciDev.Net).

Finally, a new study led by ecological economist Richard Norgaard at the University of California, Berkeley reports that the world’s richest countries owe a debt of $1.8 trillion to developing nations due to environmental damages. “We know already that climate change is a huge injustice inflicted on the poor,” said Neil Adger at the Tyndall Centre for Climate Change Research, who was not involved in the research. “This paper is actually the first systematic quantification to produce a map of that ecological debt,” he said.

Image credit: flickr.com/moran

Private and public research institutions and publications are struggling to adapt to demands for transparency and popular participation. The Columbia Journalism Review’s Observatory yesterday reviewed various experiments in open and participatory publishing, including a recent effort in the pages of Scientific American and the experiences of various blogging communities. Christie Nicholson, the community editor for Scientific American, said she would like to develop a new platform that is “not quite wiki, but more than commenting.” Scientists and science communicators working in this new field, dubbed “Science 2.0,” gather today and tomorrow in the Research Triangle at the 2008 North Carolina Science Blogging Conference (scienceblogging.com).

Google follows through on its promise to investors with a $25 million gift to an array of projects that include tracking global health risks to aiding the poor in India. When the company went public, it pledged to donate one percent of its profits and equity to “making the world a better place.” The company will offer grants and make investments of $175 million over the next three years under its philanthropy wing, Google.org. The approach is distinct in that the company will invest in for-profit ventures, allow Google employees to get involved directly, and even lobby public officials for policy changes.