Hitting the mark or falling short with nanotechnology regulation?

Regulation of all new technology ebbs and flows between periods of under- and over-regulation, often dependant on the viewpoint of the observer and the underlying objectives of the particular regulation. As illustrated by genetic modification (GM) applications, defining what constitutes appropriate regulation for a rapidly evolving technology can be difficult. Drawing upon the lessons of GM, we argue that nanotechnology will go through similar periods of inappropriate regulation.

Tomato (Lycopersicum esculentum).

Tomato (Lycopersicum esculentum) is an important fruit crop in the Americas, southern Europe, the Middle East, and India, with increasing production in China, Japan, and Southeast Asia. It is amenable to producing pharmaceuticals, particularly for oral delivery; for many of the same reasons, it is a popular vegetable. Its fruit does not contain toxic substances and is palatable uncooked; it is easily processed; the plants are able to be propagated by seed or clonally by tip or shoot cuttings; the plants have a high yield of fruit; there is reasonable biomass and protein content; and they are easily grown under containment.

Ethics, biotechnology, and global health: the development of vaccines in transgenic plants.

As compared with conventional vaccine production systems, plant-made vaccines (PMVs) are said to enjoy a range of advantages including cost of production and ease of storage for distribution in developing countries. In this article, we introduce the science of PMV production, and address ethical issues associated with development and clinical testing of PMVs within three interrelated domains: PMVs as transgenic plants; PMVs as clinical research materials; and PMVs as agents of global health. We present three conclusions: first, while many of the ethical issues raised by PMVs are familiar, PMVs add a new dimension to old issues, and raise some novel issues for ethicists and policy-makers; secondly, it is premature to promise broad applicability of PMVs across the developing world without having demonstrated their feasibility; thirdly, in particular, proponents of PMVs as a solution to global health problems must, as a condition of the ethical conduct of their research, define the commercial feasibility of PMVs for distribution in the developing world.

Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing.

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing.

Risk analysis for plant-made vaccines.

The production of vaccines in transgenic plants was first proposed in 1990 however no product has yet reached commercialization. There are several risks during the production and delivery stages of this technology, with potential impact on the environment and on human health. Risks to the environment include gene transfer and exposure to antigens or selectable marker proteins.

The next 15 years: taking plant-made vaccines beyond proof of concept.

Significant potential advantages are associated with the production of vaccines in transgenic plants; however, no commercial product has emerged. An analysis of the strengths, weaknesses, opportunities and threats for plant-made vaccine technology is provided. The use of this technology for human vaccines will require significant investment and developmental efforts that cannot be supported entirely by the academic sector and is not currently supported financially by industry.

Application of Quillaja saponaria extracts as oral adjuvants for plant-made vaccines.

Extracts from the Quillaja saponaria tree are known to provide immune potentiating responses and, hence, can be useful as adjuvants. Partial purification from the crude (food-grade) extract results in Quil A, which is contained in several veterinary vaccines. Further purification can provide concentrated saponin fractions such as QS-21, which is currently under investigation as a potential adjuvant for use in humans.

Passive immunization of mice pups through oral immunization of dams with a plant-derived vaccine.

Passive immunization plays an important role in protecting young mammals against pathogens before the maturation of their own immune systems. Although many reports have shown active immunization of animals and human through the use of plant-derived vaccines, only one report has given evidence of passive immunization of offspring through oral immunization of parents using plant-derived vaccines. In this case, a challenge alone provided the evidence of passive immunization and the mechanism through which this occurred was not investigated.