Agricultural Biotechnology

(DF) Suppose opponents of a technology inaccurately depict it as dangerous--as some would argue happened with both Alar and irradiation of food--and by doing so cost producers a lot of money. Should the opponents be liable, or should such speech be protected by the second amendment? Should they be liable in a class action on behalf of injured consumers? (see an entertaining paper on this subject by a previous year's student)

(DF) What general rules, if any, ought to apply to mandatory labelling? Consider that any label provides only a subset of the truth, and that some subsets ("this food contains arsenic"--probably true of many foods, since arsenic is a useful trace mineral in human nutrition) are more deceptive than no information at all. Consider also that if labelling provides immunity against liability, there is an incentive to overwarn--with the result that consumers ignore all warnings (the boy who cried wolf), including the important ones. Is there a good simple solution? (PYS) Should the FDA require information on genetic modification in the "Nutrition Facts" section of food labels? Would it matter what sorts of genetic modification has occurred (altering an existing gene versus placing in a completely foreign gene)?

(PYS): Given that many fruits and vegetables are cloned what line should be drawn with regard to labeling genetically modified (GM) food? For example Whole Foods claims to sell only "natural" foods yet sells seedless grapes and seedless watermelon. Similarly 7 CFR 205 defines the labeling of USDA certified organic foods.  The code does not exempt GM foods from being certified organic.Should it?

(GJ) While food is certified USDA Organic, the USDA does not inspect farmers.  Instead the USDA accredits certification companies.  In 2008 the USDA placed 15 of the 30 acccredition certifiers on probation. Should the USDA hold any liability if the certification companies continue to certify products which do not meet the federal standards 7 CFR 205?

(PYS): Current patent laws give inventors the right to exclude others from "making, using, or selling" the invention, and may sue for damages if the infringer does make, use, or sell the invention. What happens if a third party obtains a patented transgenic plant/animal (i.e. a goat that produces milk with useful human proteins), keeps it a secret until the patent expires, and then reaps the benefits of that transgenic plant/animal? Does "holding" the property constitute infringement?

(CO): If someone intentionally releases genetically modified seeds, potentially tainting “organic” or non GMO fields, what is the cause of action? Because of gaps in federal oversight, would a private cause of action be more appropriate?

(DF) The Prince of Wales waded into the biotech debate a few years ago, vowing in a column in The Daily Telegraph that he would never eat, or serve to his guests, the fruits of a technology that "takes mankind into realms that belong to God and to God alone." Does it follow that regulation of agricultural biotech would, in the U.S., violate the first amendment? How does one make that judgement in an issue where the regulation can be, and is, defended on both religious and secular grounds?

(DF) Under current law (the DSHEA), "Dietary Supplements" and drugs face different regulatory rules. How would a genetically engineered "herb" designed for some desirable effect on health fit into that system?

Genetic Testing

(DF) Suppose genetic testing develops to the point where employers routinely look at a variety of genetic characteristics in deciding whether to hire someone. Different racial groups have different distributions of some genetic characteristics. If an employer uses genetic criteria that are met by 60% of whites and 50% of blacks, is he guilty of racial discrimination?

(PYS): If genetic testing could determine lifespan and intelligence at birth, should a child who is likely to live long and be extremely bright be afforded better educational and health resources than a child who is likely to die young and have only average intelligence since the former will benefit society more in the long term? Do we already do this to a certain degree?

(DF) How should intellectual property law adjust as progress in biotechnology makes the process more like engineering and less like plant breeding? For example, should (does) the law recognize a patent on an idea in plant or animal design--a way of modifying the organism to produce some desirable feature? This would go beyond present plant patents, which merely protect a particular variety, to cover new varieties produced by someone else applying the same idea.

Biowarfare

(DF) Under the Geneva Protocol to the Hague Convention and the later Biological Weapons Convention, all forms of biological warfare are banned. Are there good reasons to treat biological warfare differently from other ways of killing people? Would those reasons still apply to much more sophisticated versions--for instance, a disease designed to burn itself out in a certain length of time or number of generations, giving it an effective range of (say) only about a hundred miles from where it started.

(PYS) Some people are completely vegan, meaning they refuse to eat any animal products. If pig genes were used in a genetic modification process to make tomatoes plumper and richer, would the company have an obligation to label the tomatoes as containing pig products? If no label was required on the tomatoes, but the vegans found out about the pig genes, could they bring an action for failure to warn?

(PYS) Bioengineers have already created transgenic plants and animals which possess certain advantageous traits from different species. What if bioengineers could create new and improved "versions" of endangered species that could withstand the environmental pollution/destruction that was causing their extinction. Should such plants and animals count as to whether a species is entitled to protection under the Endangered Species Act?

(DF) Suppose the relevant conventions are repealed and advanced biological warfare becomes one more weapon among many. A tailored disease is created which targets particular genotypes. It will predictably kill half of the population of the country we are at war with--and 100,000 Americans, mostly the descendants of immigrants from that country. Does its use raise either legal or moral problems beyond those that apply to any military tactic expected to result in some casualties among those using it--nuclear weapons that generate fallout some of which will blow onto friendly territory, for instance, or bombing enemy forces very close to friendly forces.


CO: Crystal Ong
DF: David Friedman
PYS: Previous Year's Student


Links for Non-human Biotech

Legal research from previous years on genetic engineering , lasik surgery and hand transplants, genetic screening., and

agricultural biotech in the third world.

Jonathan Lyvere's research on regulation of agricultural biotech.

Stan Chang's research on healthcare privacy law.

Kristie Weber's research for this year  on the regulation of functional food.


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