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result(s) for
"Plant biotechnology -- Law and legislation -- United States"
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Corporate crops : biotechnology, agriculture, and the struggle for control
by
Pechlaner, Gabriela
in
Agribusiness
,
Agricultural biotechnology
,
Agricultural biotechnology -- Canada
2012,2021
Biotechnology crop production area increased from 1.7 million hectares to 148 million hectares worldwide between 1996 to 2010. While genetically modified food is a contentious issue, the debates are usually limited to health and environmental concerns, ignoring the broader questions of social control that arise when food production methods become corporate-owned intellectual property. Drawing on legal documents and dozens of interviews with farmers and other stakeholders, Corporate Crops covers four case studies based around litigation between biotechnology corporations and farmers. Pechlaner investigates the extent to which the proprietary aspects of biotechnologies—from patents on seeds to a plethora of new rules and contractual obligations associated with the technologies—are reorganizing crop production. The lawsuits include patent infringement litigation launched by Monsanto against a Saskatchewan canola farmer who, in turn, claimed his crops had been involuntarily contaminated by the company’s GM technology; a class action application by two Saskatchewan organic canola farmers launched against Monsanto and Aventis (later Bayer) for the loss of their organic market due to contamination with GMOs; and two cases in Mississippi in which Monsanto sued farmers for saving seeds containing its patented GM technology. Pechlaner argues that well-funded corporate lawyers have a decided advantage over independent farmers in the courts and in creating new forms of power and control in agricultural production. Corporate Crops demonstrates the effects of this intersection between the courts and the fields where profits, not just a food supply, are reaped.
Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts
by
Sprink, Thorben
,
Schiemann, Joachim
,
Hartung, Frank
in
Biomedical and Life Sciences
,
Biotechnology
,
breeding
2016
Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.
Journal Article
Assessing the Effects of Medical Marijuana Laws on Marijuana Use: The Devil is in the Details
2015
This paper sheds light on previous inconsistencies identified in the literature regarding the relationship between medical marijuana laws (MMLs) and recreational marijuana use by closely examining the importance of policy dimensions (registration requirements, home cultivation, dispensaries) and the timing of when particular policy dimensions are enacted. Using data from our own legal analysis of state MMLs, we evaluate which features are associated with adult and youth recreational and heavy use by linking these policy variables to data from the Treatment Episode Data Set (TEDS) and National Longitudinal Survey of Youth (NLSY97). We employ differencesin-differences techniques, controlling for state and year fixed effects, allowing us to exploit within-state policy changes. We find that while simple dichotomous indicators of MML laws are not positively associated with marijuana use or abuse, such measures hide the positive influence legal dispensaries have on adult and youth use, particularly heavy use. Sensitivity analyses that help address issues of policy endogeneity and actual implementation of dispensaries support our main conclusion that not all MML laws are the same. Dimensions of these policies, in particular legal protection of dispensaries, can lead to greater recreational marijuana use and abuse among adults and those under the legal age of 21 relative to MMLs without this supply source.
Journal Article
A risk-based approach to the regulation of genetically engineered organisms
2016
Current regulatory regimes for genetically engineered crops fail to use a scientifically defensible approach or tailor the degree of regulatory review to the level of actual hazard or risk. We describe a rational way forward.
Journal Article
Evolution of a regulatory framework for pharmaceuticals derived from genetically modified plants
by
Ma, Julian K.C.
,
Twyman, Richard M.
,
Sparrow, Penelope A.C.
in
Agricultural biotechnology
,
Agricultural production
,
Biological and medical sciences
2008
The use of genetically modified (GM) plants to synthesize proteins that are subsequently processed, regulated and sold as pharmaceuticals challenges two very different established regulatory frameworks, one concerning GM plants and the other covering the development of biotechnology-derived drugs. Within these regulatory systems, specific regulations and guidelines for plant-made pharmaceuticals (PMPs) – also referred to as plant-derived pharmaceuticals (PDPs) – are still evolving. The products nearing commercial viability will ultimately help to road test and fine-tune these regulations, and might help to reduce regulatory uncertainties. In this review, we summarize the current state of regulations in different countries, discuss recent changes and highlight the need for further regulatory development in this burgeoning, new industry. We also make the case for the harmonization of international regulations.
Journal Article
‘Do Not Privatize the Giant's Shoulders’: Rethinking Patents in Plant Breeding
Intellectual property rights (IPRs) have increasing impacts on plant breeding. Not only varieties but also germplasm and technologies are protected. Intellectual property has also affected corporate concentration in the seed supply chain. While not very controversial in the USA, it is increasingly controversial in Europe after rulings on plant patents concerning nontransgenic crops in 2015. Both political and industry voices call for new interpretations or legislations. Industry initiatives have opened facilitated patent access systems designated ‘free access, but not access for free’. Although praiseworthy, they are voluntary and so far limited to vegetable crops. This Opinion article suggests a mandatory system of declaring IPR use linked to variety registration. This compulsory licensing system with ‘toll roads, not road blocks’, is likely to reward IPRs without delaying breeding progress.
Once considered ‘the common heritage of mankind’, plant germplasm resources have become enclosed through rights spanning from international conventions to national and civil laws.
Patents and material transfer agreements increasingly limit the breeders’ exception guaranteed by intergovernmental agreements.
In 2015, the Enlarged Board of Appeals (EBA) effectively nullified the prohibition to patent ‘plant and animal varieties and essentially biological processes’.
Four European governments have introduced breeding exceptions in their patent laws, with Germany also excluding ‘essentially biological processes’.
Since 2012 industry has launched patent pools and e-licensing to facilitate access.
NGOs address patents from a food security perspective.
Journal Article
Governmental Provisions to Manage and Eradicate Feral Swine in Areas of the United States
by
Shuman, Rebecca M.
,
Centner, Terence J.
in
Agricultural production
,
Agriculture
,
Animal control
2015
Feral swine (wild hogs) are one of the most widely distributed free-ranging mammals in the world. In the United States, feral swine serve as game animals for the sport of hunting in some areas, while they are nuisance species at other locations. Increasing feral swine populations creates negative impacts to growing crops, native plant communities, and wildlife. Feral swine can also serve as reservoirs for a number of bacterial and viral diseases that can infect wild animals, livestock, and humans. The US state governments are adopting statutes and regulations to reduce the growth and dispersal of feral swine populations. An analysis of these provisions suggests that while they seek to control feral swine populations, they are unlikely to provide any significant relief from damages to crops and native ecosystems. More localized reduction plans and a national disease control program are suggested to assuage damages being wrought by these invasive animals.
Journal Article