Check out this recent Bloomberg piece from Cass Sunstein: Don’t Mandate Labeling for Gene-Altered Foods. He raises a number of arguments that came out during the Q&A following our recent conference panel on food regulation. Video should be posted soon!
[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]
Moderated by Emily Broad Leib, Harvard Law School
Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.
By GM we mean rDNA modification not husbandry and not careful selection.
FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.
In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.
In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.
Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.
Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.
Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.
On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.
Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.
Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:
Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.
by Adriana Benedict
Today, Professor Glenn Cohen announced on this blog that he, in conjunction with two others, filed an amicus brief in AMP v. USPTO (Myriad), a case concerning Myriad’s patents on isolated DNA and cDNA. In a paper I have been writing on the natural phenomenon doctrine as applied to biotechnology patents, I arrived at this conclusion about the doctrine’s implications for Myriad:
According to Mayo v. Prometheus, the preemption rationale for the natural phenomenon doctrine suggests that any patent on a diagnostic biotechnology product or process should be limited to the inventive use of that product or process as defined by its associated process or product, respectively. As applied to Myriad, this qualified interpretation of the natural phenomenon doctrine would suggest that ideally these patents ought to be limited to Myriad’s one remaining valid method claim, namely claim 20 of the ‘282 patent, “a method for screening potential cancer therapeutics.” The unavoidable and unsettling problem with such a conclusion, of course, is that at this stage in litigation, it is not possible for the Court to limit Myriad’s gene patents in this way. This procedural limitation sheds some light on the elephant in the natural phenomenon doctrine: If the doctrine was meant to exclude certain categories of discoveries from patentability before Congress had the opportunity to refine more specific patent validity rules, then perhaps it should be limited to carrying out that function at the outset of a patent prosecution. The natural phenomenon doctrine serves the important purpose of ensuring that patents do not contravene their Constitutional objective by too broadly preempting the use of “basic tools of science.” It does so by balancing the scope of preemption against the scope of invention, and ensuring that the scope of preemption does not exceed that which is justified by the inventor’s handiwork in applying natural phenomena. At the patent prosecution stage, the natural phenomenon doctrine is a useful “catch-all” analytical tool that allows flexibility in promoting the spirit of patent law when the letter of patent law has not kept pace with the progress of science. But at the litigation stage, its Achilles heel is that it may prove too much: In the absence of a procedural option to limit a patent at this stage, the natural phenomenon doctrine is forced to err on either the side of all or nothing. While the doctrine may be useful at the patent prosecution stage, it was not (as other statutory patentability requirements were) appropriately designed to assess the validity of patents once they’ve been issued in a way that is compatible with today’s patent litigation procedures. As a doctrine of limitation, it must in this context either fall, and prove nothing at the expense of unwarranted preemption, or rise, and prove too much at the expense of patent holders who have been reasonably relying on guidance from the USPTO regarding gene patents for many years.
I am unable to find any commentary exactly on this point, but some issues concerning the jurisdictional authority of §101 have been raised in response to both Mayo and CLS Bank v. Alice. While these cases concern biotechnology processes and software, respectively, they are extremely relevant to Myriad if we consider isolated genes / cDNA to be the equivalent of biological software. Indeed, Professor Ronald Mann observed that “Though most of the attention to …[Mayo] has focused on its immediate implications for medical providers, the broader effect of the case probably will be on the software industry.”
Manufacturers assert that they have no obligation to provide consumers with notice through labeling when ingredients created through innovative technologies are introduced into consumer products designed for human consumption. On the other hand, consumers take the position that they have the right to know what ingredients are in these products, especially when ingredients are novel and the risks associated with exposure to them are unknown. Recent events suggest that this problem may be developing a life cycle that savvy manufacturers should be watching. The first in what may be a series of examples of this life cycle is the conflict over the labeling of genetically modified plant ingredients in food.
From the outset, food manufacturers using GMO ingredients have declined to provide consumers notice of GMO content. The FDA has not mandated disclosure as it takes the position that the introduction of GMO ingredients into food is not material. This lack of transparency resulted in consumer rights groups testing products for GMO use and disclosing that use to consumers. As consumers have become aware of the extensive use of GMOs in their food, a rising number have expressed the desire that these ingredients be labeled. A recent ABC poll suggests that 93% of consumers now support mandatory disclosure of GMO content on labels.
When industry ignored this consumer preference, a market was created for products that are “GMO-free.” Thus, the practice of “GMO-free” labeling was born. The growing consumer labeling movement also triggered repeated attempts to pass labeling laws. While these efforts have been unsuccessful to date, they are gaining traction – for instance, it cost industry 40 million dollars to block California’s prop 37 calling for mandatory labeling last fall. With more legislative proposals cropping up (a ballot initiative in Washington State and legislative proposals in Connecticut, Vermont, New Mexico and Missouri), a growing consumer boycott of some organic or “natural” brands owned by major food companies and a recently introduced popular mobile app by Fooducate that allows consumers to check for GMO content in a growing number of products, industry may be seeing the writing on the wall. Just this year, Ben & Jerry’s Ice Cream has decided to remove GMO ingredients from its supply chain. And the Meridian Institute, which organizes discussion of major issues, convened a meeting in Washington last month that included executives from PepsiCo, ConAgra and about 20 other major food companies, as well as Wal-Mart and advocacy groups that favor labeling. See here. Many are predicting that voluntary labeling may be right around the corner.
It appears that this life cycle of manufacturers’ refusal to disclose innovative ingredients with unknown risks and consumers’ reactive self-help measures may be repeating itself in the context of the use of nanotechnology in consumer products.
Two big events recently took place in the world of food: The Food and Drug Administration decreed that genetically engineered salmon wouldn’t harm the environment and McDonald’s announced that its McRib sandwich is back on the menu.
The FDA’s announcement paves the way for the first approval of a genetically engineered animal for humans to eat – and it was met with a good deal of highly critical wailing and groaning by Consumer’s Union, National Geographic and many other advocacy groups who are wary of genetically engineered food.
If you like salmon, and I do, should you worry much about the safety of eating genetically engineered salmon? No. The FDA said it could not find any valid scientific reason to prohibit the sale of the fish.
If you like the McRib, and I do, should you worry a lot about eating it? Oh yeah.
Nadia N. Sawicki
Google’s informal corporate slogan is “Don’t be evil.” Whole Foods is a Fortune 500 company with a net revenue of 10 billion dollar that prides itself on a commitment to social responsibility. Both companies have pledged to do long-term good in the world, even at the expense of short-term gains, and both are wildly successful.
If corporations can be profitable as a result of their commitments to social justice and corporate ethics, why can’t this doctrine be extended to the pharmaceutical industry? Someday, a company called GoodPharma might reach the Fortune 500 on the basis of a pledge to improve access to medicine, conduct international research trials in accordance with the highest standards of research ethics, engage in research on orphan diseases, publish negative research findings, promptly report information about adverse effects, and generally act as a model for ethical industry practices. If this business model hasn’t been explored, it should be.
The Environmental Protection Agency has determined that Monsanto’s request to plant a new strain of genetically-modified corn “may be of regional and national significance.” As a result, the agency is seeking public comment on Monsanto’s application.
Monsanto seeks permission to test the new corn in Puerto Rico and 22 states over the next two years. The corn is bioengineered to produce Bacillus thuringiensis (BT), a bacteria that is known to kill rootworm. The risks of BT-engineered crops are not fully known. In addition to impacting the biodiversity of the soil and environment, BT toxin is known to kill other insects such as moths and butterflies, and some have argued that crops genetically-engineered to produce BT toxin have led to colony collapse disorder which has devastated beehives all over America for a number of years.
To be sure, naturally-occurring BT-products are allowed for USDA certified-organic production, and genetically modified BT-corn may be more environmentally friendly that other strains of genetically-modified corn since the corn itself produces the toxin, and thus theoretically would require less spraying of pesticides. However, rootworm is known to adapt quickly and become resistant to bioengineered BT toxin. In fact, farmers have had to spray their corn with chemical pesticides that the bioengineered BT corn was supposed to avoid. Notably, studies have found that genetically-modified BT crops adversely impact the health of humans and livestock, while BT toxin has been discovered in the blood of pregnant women and fetuses. Given the widespread health and environmental concerns, to the extent the EPA is inclined to grant Monsanto’s request, the agency should condition the experimental use on funding for independent research that evaluates the long-term effects of bioengineered BT crops on humans, livestock, and the environment.
By Katie Booth
This November, voters weighed in on an array of state ballot initiatives on health issues from medical marijuana to health care reform. Ballot outcomes by state are listed below (more after the jump).
Voters in Alabama, Montana, and Wyoming passed initiatives expressing disapproval of the Affordable Care Act, while a similar initiative in Florida garnered a majority of the vote but failed to pass under the state’s supermajority voting requirement. Missouri voters passed a ballot initiative prohibiting the state executive branch from establishing a health insurance exchange, leaving this task to the federal government or state legislature. Florida voters defeated a measure that would have prohibited the use of state funds for abortions, while Montana voters passed a parental notification requirement for minors seeking abortions (with a judicial waiver provision). Perhaps surprisingly, California voters failed to pass a law requiring mandatory labeling of genetically engineered food. Several states legalized medical marijuana, while Arkansas voters struck down a medical marijuana initiative and Montana voters made existing medical marijuana laws more restrictive. Colorado and Washington legalized all marijuana use, while a similar measure failed in Oregon. Physician-assisted suicide was barely defeated in Massachusetts (51% to 49%), while North Dakotans banned smoking in indoor workplaces. Michigan voters failed to pass an initiative increasing the regulation of home health workers, while Louisiana voters prohibited the appropriation of state Medicaid trust funds for other purposes.
Affordable Care Act:
- Alabama Health Care Amendment, Amendment 6: Approved 59.52% to 40.48% (prohibits mandatory participation in any health care system)
- Florida Health Care Amendment, Amendment 1: Defeated 51.46% to 48.54% (required 60% support to pass) (would have prohibited passing laws compelling the purchase of health insurance)
- Missouri Health Care Exchange Question, Proposition E: Approved 61.8% to 38.2% (“prohibit[s] the Governor or any state agency, from establishing or operating state-based health insurance exchanges unless authorized by a vote of the people or the legislature”)
- Montana Health Care Measure, LR-122: Approved 66.83% to 33.17% (prohibits “the state or federal government from mandating the purchase of health insurance coverage or imposing penalties for decisions related to the purchase of health insurance coverage”)
- Wyoming Health Care Amendment, Amendment A: Approved 76.98% to 23.02% (stating that “the right to make health care decisions is reserved to the citizens of the state of Wyoming”)
[posted on behalf of Art Caplan]
Greenpeace, perhaps best known for its battles at sea to protect whales and the oceans, has gotten itself involved in a huge controversy over genetically modified food.
The group is charging that unsuspecting children were put at risk in a “dangerous” study of genetically engineered rice in rural China. It’s a serious claim, because it is putting research seeking to put more nutrition into food at risk.
Genetically engineered rice has the potential to help solve a big nutritional problem—vitamin A deficiency. A lack of vitamin A kills 670,000 kids under 5 every year and causes 250,000 to 500,000 to go blind. Half die within a year of losing their sight, according to the World Health Organization. I think Greenpeace is being ethically irresponsible and putting those lives at continued risk.
Read the rest over at NBCNews Vitals.