ANS/PLSS 433: Environmental, Social, and Ethical Issues

Introduction: 

	Among the public policy and legal issues created by 
biotechnology, patents, deliberate release of organisms and the future of 
Biotechnology in the Third World are of particular relevance to agricultural
biotechnology. All the above contain a legal aspect. Law appears irrational 
to a logical scientist because the interpretation of new laws is the result 
of courtroom debate within the framework of existing laws. Laws and 
guidelines have been developed by the government agencies such as the NIH, 
USDA, FDA and EPA are intended to support a new industry while protecting 
the public from unecessary risks.

Patent Law: 

	A patent is rights granted in respect of inventions capable of 
industrial applications. To get the rights requires registration- filing a 
patent application. A patent examiner determines if the invention is BOTH 
novel AND non-obvious the patent is issued. There must be no prior 
disclosure. In return for the patent the inventor must supply a full 
description of how his invention was made. Patents can be challenged in a 
law court or infringed upon by competitors.

What can be Patented: 

	The three categories of patent are compositions, 
processes and methods. Compositions patent are most effective as 
infringement is detected by product analysis and they are international. 
New antibiotics, herbicides or bacterial species  and newly highly purified 
products are patentable. If one is forced to patent a process its necessary 
to file multiple claims for every production method imaginable. Because 
process patent infringement is hard to prove companies prefer to retain 
the information as a trade secret. Methods patents are used to protect 
new-uses for old products or mixtures of old products. Microorganisms can 
be patented since Diamond vs Chakrabrty 1980. Plants and animals can be 
patented in the US but not Europe where more limited plant variety rights 
are granted but no animal right exist unless the process patented can apply 
to several plant varieties or animal species!

The uncertainty of Patents: 

	Patent litigation in biotechnology is often reduced to debates 
between opposing paid expert witnesses. The variations in patent law makes 
things worse eg prior disclosure means less than 1 year in the US but 
never in Europe. 

Regulating recombinant DNA Technology:

     In 1974 scientist worldwide declared a moratorium on rDNA research 
whilst it was determined if such research was safe. The NIH first developed 
stringent guidelines then adapted guidelines to be more relaxed as the 
safety of the technique was established. To date no "monsters" have been 
produced from non-pathogenic organisms. Pharmaceuticals made from rDNA were 
accepted as not different from drugs made by other methods on composition 
to expedite life saving treatments. This has proven true and set the 
prescedent for the whole biotech industry.

Food and Ingredient Safety:

     The US FDA is resposible for regulating food safety. Toxicity, 
allergenicity and impurity testing is at initial stages for all new 
ingredients. Chymosin from rDNA was not delayed because the chymosin from 
calf stomachs was not different nor safer (probably less safe). 
However, changes in methods (trade secrets) are not so stringently regulated
hence rDNA produced Trptophan (impurity ethylene-bis-Trp) lead to an 
increase in eosinophilia-myalagia syndrome after the purification methods 
were streamlined. Hence, although rDNA was not the causitive problem even 
minor changes in source organisms should always be safety tested. BST made 
by rDNA is used to increase milk consumption. It favors large producers 
over small, reduces prices and profit margins. It is safe, does not cause 
cancer in humans nor mastitis in cows. rDNA was used as a bogeyman in the 
anti-campaign based on a threat to peoples livelyhood. 
     
Deliberate Release of Genetically Engineered Organisms

Bacteria: 
	
	Non pathogenic bacteria in culture pose few problems when they are 
killed before release (Eg P.fluorescens with Bt toxin). However some 
situations require release of live bacteria and their proliferation 
(eg. P.syringae ice-nucleation minus). For over 50 years microbiologists 
have been releasing microorganisms, Rhizobium for plant nodulation, 
B.thuringiensis for insect kill and others. How will genetic engineering 
with specific genes make the situation worse? Escape of genes from organism 
is a common bacterial process anyway. Released organisms are usually 
uncompetitive and nonpersistent. However a statement of environmental 
impact is necessary before the release of new organisms which require 
field test releases and recaptures!
 
Plants: 

Escape is less alarming as we can see plants, also gene escape is less 
prevalent. However the crossing of herbicide resistant plants with weedy 
relatives to produce super weeds is an area of concern, but couldn't it 
happen with conventional breeding? (single gene vs polygenes). The vectors 
for plant transformation are ideal as the transferred DNA integrates in 
chromosomes and loses the ability to be transferred in the process. 
Opposition to herbicide resistant plants is particularly intense since 
many feel more herbicide will used, wild habitat will be reduced, no-till 
will be difficult. Biotech companies claim its a battle for market share 
which will result in the substitution of safer herbicides.

Food Safety: 

	Concerns arise over the consumption of the engineered gene but also 
the selectable marker gene. Is it digestable or allergenic or carcinogenic? 
Such issues are addressed with extensive feeding studies in rats and humans 
before release. Another concern might be future recombination between the 
powerful plant gene promoter and a latent plant toxin. Both can occur 
without genetic engineering! Ag Biotech companies feel genetically 
engineered food is so safe the consumer doesnt need to be told what they 
are eating through an ingredient list. Rather food for refusniks should 
bear the expense of separation and labelling rather as organically produced 
food does presently.

Anti corporate Feeling: 

	The Application of Biotechnology is the domain of large corporations
by the nature of some of its inventions. Often these advances favour large 
combines rather than small producers (eg BST milk). Public sympathy is 
therefore lacking despite the tremendous potential for good if the industry 
is wisely regulated.