Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading →
In addition to the closely-watched senate and gubernatorial candidates, 146 ballot questions were up for vote yesterday in 42 states across the nation. Below is a review of the some of the most pressing bioethics issues on the docket and the latest information on what passed according to Politico’s Ballot Tracker. Continue reading →
I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.
The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.
But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.
Emerging Issues and New Frontiers for FDA Regulation
Monday, October 20, 2014
We are currently seeking abstracts for academic presentations/papers on the following topics:
Stem cell therapies
Genetic (and biomarker) tests
Comparative efficacy research
Drug resistant pathogens
Mobile health technologies
Other related topics
Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at firstname.lastname@example.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.
We will notify selected participants by the end of June. Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ). Publication decisions will be made based on usual FDLJ standards.
The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.
The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops. While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.
As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s. Prior to this development, weed management required significant skill and knowledge. Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices. Herbicide-resistant crops, by contrast, were effective and easy to use.
During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant. By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds. The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.
In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem. The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance. Continue reading →
This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.
KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective
In the debate over whether genetically modified organisms should be allowed in the food supply or labeled when they’re used, a central question is whether GMOs are any more dangerous to people eating them than other foods. This is far from the only concern raised by GMOs—that list includes things like the dangers of pervasive monoculture over diversity, intellectual property issues about crop ownership, the loss of traditional food sources, and the unintentional spread of modified organisms—but it’s a big one, and a major lever of consumer engagement.
In this debate, a significant piece of evidence frequently cited by the anti-GMO camp was a 2012 study by Seralini et al. that rats fed Roundup-ready corn were more likely to develop cancers (Roundup-ready corn is sold by Monsanto and is resistant to its popular herbicide Roundup). I say was because the journal, Food and Chemical Toxicology, has just retracted the paper. The paper was hugely controversial—which certainly isn’t justification for retraction—but that controversy prompted the editors to take a closer look at the raw data, after which they concluded that the number of rats studied was too low to justify the paper’s conclusions.
This episode unfortunately illustrates, among other things, the problems with intense media attention to early scientific reports, and with research-as-weapon rather than research-as-information. Part of the hubbub came from the draconian embargo imposed on journalists before the article was published: because journalists weren’t permitted to seek any independent evaluation before publication of the article, many media reports ran enthusiastic coverage of the article before the scientific community started pointing out the many flaws in the research. The eventual feedback from the scientific community—part two of peer review, when publications are criticized in the literature and addressed by letters and other publications—was certainly powerful, and led to the retraction. But that doesn’t change the fact of its initial publication, and I’d bet quite a bit that the article will be cited for years to come as evidence that there’s not scientific consensus on this issue. In fact, in a depressingly unsurprising development, Seralini is threatening to sue the journal over the retraction.
In Washington state, a proposal (Initiative 522) to require labeling of genetically modified (GM) or engineered (GE) foods was defeated recently by votes of 45.17% in favor and 54.83% against. The state law would have implemented mandatory labeling requirements on food composed of 0.9% or more of GM ingredients, measured by weight. Prospects for passage of the proposal were quite promising when it was first introduced. But, the scenario shifted when GM food companies, including General Mills, Nestle USA, PepsiCo, Monsanto, etc., launched a multi-million dollar advertisement campaign challenging the justification for GM labeling.
The downfall of the proposal, while disappointing consumer groups, is not likely to stop the labeling movement. Actually, there have been many other attempts to regulate GM foods on a state level. California Proposition 37, which would have imposed labeling requirements similar to the Washington proposal, was put to a vote last year, but failed to pass. According to Just Label It, a NGO, more than 20 state laws were introduced about GM labeling this year.
Many scientists trust the safety of GM foods, and the benefits brought by the development of GM agriculture are obvious. GM crop production can reduce the use of pesticides and enhance yields. By contrast, in addition to possible new allergies caused by the consumption of GM foods, some worry about their potential harm to the environment and ecological system. On the federal level, three agencies are competent to regulate GM crops and foods: the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), which use existing rules to regulate. Yet, the inadequacy of their oversight has been disclosed. Until now, no specific federal law has been enacted to regulate GM food production and consumption.
In the United States, over 250 million turkeys are slaughtered each year, with over 45 million just for Thanksgiving. The overwhelming majority of these birds (over 99%) are a genetically engineered and industrially-farmed breed known as Broad Breasted White. As the name suggests, this breed of turkey has an unnatural abundance of white breast meat. In many ways, industrial turkey farms are similar to industrial chicken farms–typically there are thousands of birds packed into a closed space with no natural light, no access to the outdoors, and mechanized feed and water (often laced with antibiotics and growth hormones). Adult turkeys in an industrial farm typically cannot walk properly or reproduce on their own, and artificial insemination is the norm. The eggs are hatched in an incubator and newborns have no contact with their mother. Shortly after birth, the young turkeys are placed into a large dark warehouse that will be the only space they will ever know. Their toes and beaks are cut without pain killers. Due to the grotesque environment, millions of birds die from “stress-induced conditions“. Those that survive grow at an astonishing rate, attaining market weight in just 12-18 weeks. The adults often are blind, due to lack of natural light and other factors (such as pecking fights in the tight quarters). According to one study, if a 7 pound human newborn grew at the same rate as an industrial turkey, it would be 1,500 pounds at 18 weeks of age.
A small but growing number of turkeys are non-genetically engineered Heritage Breeds. Heritage Breeds were in existence prior to the industrial-farming practices introduced in the 1960s, with some breeds tracing their roots to the 1800s. Standard farming practices for Heritage breeds include liberal roaming of pastures, humane growing conditions, and no antibiotics or growth hormones. Heritage turkeys are difficult to find, with some farmers requiring advanced notice (often months in advance) to purchase. The higher cost of Heritage turkeys (about $7 a pound, compared to approximately $1.50 a pound for industrial birds) reflects the higher cost of raising them, as well as insufficient subsidies for farmers employing organic and/or sustainable practices (along with over-subsidization of industrial and corporate farms).
It’s important to note that an organic turkey is not necessarily a Heritage breed. An organic turkey is any breed that has been fed an organic diet. Similarly, a free-range turkey is not necessary a Heritage breed. In fact, free-range does not mean that the turkey has actually stepped foot on a pasture. Rather, under USDA regulations, a bird can be labeled free-range if it lives in a space where there is access to the outdoors. Reaching the outdoors is immaterial. If knowing your turkey matters to you, be sure to ask the right questions, including the breed of the turkey, what feed the turkey has been provided (including whether the feed was comprised of genetically-modified ingredients), whether the turkey has been given antibiotics or other drugs or hormones, and whether the bird actually foraged in a pasture.
If you were watching television this week you may have seen this clip of a taste test for hamburger meat grown in a “test tube” in London discussed here. The meat was grown from stem cells from existing cows used to grow 20,000 strands of tissue. Costing more than $330,000 to make, with funding by google Co-Founder Sergey Brin, the day where this will be available at your grocery store or served at your fast food franchise is far away. But it may come sooner if we conclude that there may be a moral duty to develop and eat this kind of meat rather than animal-grown meat and press our governments to start funding this work. What is the morality of test tube meat consumption?
Sometimes narrative can be a way into ethics so consider this bit from one of my favorite novelists (and Canadian public intellectuals) Margaret Atwood from her novel Oryx and Crake. She imagines a dystopian future that includes the the consumption of “Chickie Knobs” in one scene:
“This is the latest,” said Crake.
What they were looking at was a large bulblike object that seemed to be covered with stippled whitish-yellow skin. Out of it came twenty thick fleshy tubes, and at the end of each tube another bulb was growing.
“What the hell is it?” said Jimmy.
“Those are chickens,” said Crake. “Chicken parts. Just the breasts, on this one. They’ve got ones that specialize in drumsticks too, twelve to a growth unit.
“But there aren’t any heads…”
“That’s the head in the middle,” said the woman. “There’s a mouth opening at the top, they dump nutrients in there. No eyes or beak or anything, they don’t need those.”
To be clear the test tube meat unveiled earlier this week is not a Chickie Nob, it is grown from stem cells rather than being a cow with extra parts and brains missing (Atwood is silent on some characteristics of the Chickie Nob that may matter ethically such as whether it feels pain or is sentient), but I think many will react to the test tube meat the same way: disgust. Some in bioethics, like Leon Kass, think there can be a “Wisdom of Repugnance.” In my own work I have been a persistent skeptic on this theme. For me repugnance and disgust are good and should be cultivated as reactions for that which we deem immoral, but should be broken down and overcome for those things which we conclude are morally worth pursuing. Thus repugnance is a tool whose proper deployment depends on prior moral conclusions. In the case of test tube meat, whatever repugnance we feel is one we should get over and media, government, etc, should help us do so.
One fear about GMOs is that they will escape whatever controls are placed them and end up in the wild. A version of that story appears to have come true in the wheat industry this week, when the USDA announced that farmers in Oregon had discovered an unexpected and unapproved patch of Roundup-Ready genetically modified wheat in a conventional wheat field. Monsanto developed Roundup-Ready wheat (which is not resistant to its Roundup herbicide) and tested it between 1998 and 2005, but it was never approved for sale and was discontinued. Japan has cancelled or suspended orders of wheat from the Pacific Northwest in response.
Monsanto has been receiving quite a bit of press recently. Marchers in over 400 cities protested the company and the GMOs it makes took place a few days ago, arguing that foods should be labeled if they contain GMOs.
More broadly relevant to the biotech industry and GMOs generally, a few weeks ago, the Supreme Court released its 9-0 opinion in Bowman v. Monsanto, No. 11-796. This case shores up the patent-law foundation for the GMO seed business (as was widely expected), but also takes an interesting turn involving intent and self-replicating technology in general. Continue reading →
I’ve become increasingly interested in GM crops, in general, after the recent Petrie-Flom Conference on the FDA in the 21st Century.
I know there is a lot of discussion and controversy about genetically-modified (GM) crops. I want to pick-up on a topic that is related to GM crops – that is, the environment. The May 2nd issue of Nature includes a special section on GM crops. Part of this section provides information on the environmental advantages of GM crops. Most of the GM crops contain DNA that allows them to be resistant to herbicides or insects. It turns out that a study showed that there was a 6.1% reduction in the use of herbicide between 1996 and 2011 on crops of herbicide-resistant cotton compared to the amount of herbicide that would have been used to treat conventional crops. See Natasha Gilbert, A Hard Look at GM Crops, 497 Nature 24, 25 (2012) (I believe this article is free if you search for it on the Nature website). A reduction in the amount of herbicide used to treat our fabric or food sources may have environmental advantages. Less herbicide run-off into waterways. Less herbicide for animals to consume. See id.
Other scientific data provide inconclusive results about environmental impacts. Some studies look at whether transgenes are spreading to weeds or non-GM crops. For example, husbandry techniques of cross-breeding may unknowingly cross breed a non-transgenic line with a transgenic line and thereby create a transgenic line. Now, a GM crop will be grown without the farmer even knowing it. See id. at 24, 26. And, if the GM crop has some sort of negative environmental impact, then a farmer may unwittingly be creating potential harm to the environment.
One thing I want to raise with this post is the importance to incorporate multiple areas of study – biology, environmental studies, genetics, health, regulation, etc. – to determine how we advance our understanding of GM crops. I imagine that many readers of this blog are much more familiar with GM crops than me, so I welcome your comments.