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TITLE:  Making 'safety first' a reality for biotechnology products
SOURCE: Nature Biotechnology, Volume 21 (6): 599 - 601
        by Anne R Kapuscinski et al.
DATE:   June 2003

------------------ archive: http://www.gene.ch/genet.html ------------------


Making 'safety first' a reality for biotechnology products

Anne R Kapuscinski1, Robert M Goodman2, Stuart D Hann3, Lawrence R
Jacobs4, Emily E Pullins5, Charles S Johnson6, Jean D Kinsey7, Ronald L
Krall8, Antonio GM La Viņa9, Margaret G Mellon10 & Vernon W Ruttan11


[read more at: http://www.fw.umn.edu/isees/]


1. A.R.K. is in the Department of Fisheries, Wildlife and Conservation
Biology, 200 Hodson Hall, 1980 Folwell Ave., St. Paul, Minnesota 55108,
USA and at the Institute for Social, Economic and Ecological
Sustainability, 186 McNeal Hall, 1985 Buford Ave., St. Paul, Minnesota
55108, USA
2. R.M.G. is in the Department of Plant Pathology and Gaylord Nelson
Institute for Environmental Studies, University of Wisconsin-Madison,
Madison, Wisconsin 53706, USA
3. S.D.H. is a commercial aerospace system safety engineer based at 21382
Pensacola Cir., Huntington Beach, CA 92646, USA
4. L.R.J. is in the Department of Political Science, University of
Minnesota, Minneapolis, Minnesota 55455, USA and at the Institute for
Social, Economic and Ecological Sustainability
5. E.E.P. is at the Institute for Social, Economic and Ecological
Sustainability
6. C.S.J. formerly of Dupont is retired and now living at 4935 Mesa
Capella Drive, Las Vegas, Nevada 89148, USA
7. J.D.K. is in the Department of Applied Economics and at The Food
Industry Center, 317 Classroom Office Building, University of Minnesota,
St. Paul, Minnesota 55108, USA
8. R.L.K. is at GlaxoSmithKline, P.O. Box 1539, King of Prussia,
Pennsylvania 19406, USA
9. A.G.M.L.V. is at the World Resources Institute, 10 G St. NE, Ste. 800,
Washington, DC 20002, USA
10. M.G.M. is at the Food and Environment Program, Union of Concerned
Scientists, 1707 H St. NW, Ste. 600, Washington, DC 20006, USA
11. V.W.R. is in the Department of Applied Economics, University of
Minnesota, St. Paul, Minnesota 55108, USA. e-mail: isees@fw.umn.edu


A critical challenge facing the advocates of biotechnology is to fortify
the biosafety of genetically engineered organisms. Readers of this
journal have seen competing notions on how to achieve biosafety. For
some, scientists carry the burden of designing better biosafety through
'backup safety precautions'1 and 'molecular gene-containment
strategies'2. Some have advocated that industry should take the lead in
adopting more stringent safety criteria3. Others have argued that
biosafety science requires significant public investment in order to
assess the potential risks of biotechnological products4. All seem to
agree that 'some form of control mechanism is needed' to minimize
genetically modified (GM) product risks and maximize product and
environmental safety5. Prospective and preventative approaches to
strengthening biosafety science and policy, however, have been lacking.

Over the past three years, our colleagues and we have developed a new
'Safety First Initiative,' a public-private partnership for transparent
development of proactive safety standards that anticipate and resolve
safety issues as far upstream of commercialization as possible. The
Initiative's purpose is to establish cross-industry (agriculture,
biotechnology, food processing, food marketing and retail) and socially
robust safety standards for designing, producing and monitoring the
safety of agricultural biotechnology products from laboratory bench to
the consumer's dinner plate, with safety a primary criterion from the
outset. The Initiative's executive advisory board (John Block, former
Secretary of Agriculture; Charles S. Johnson, former executive vice
president, DuPont; Margaret G. Mellon, program director, Union of
Concerned Scientists; Vin Weber, former US representative; John
Woodhouse, former CEO, SYSCO Corp.) and steering committee
(representatives of biotechnology businesses, farming, retail food
business, consumer and environmental groups and diverse scientific
experts) have decided to apply a consultative and transparent process to
incorporate scientific, technical, social and governmental considerations
in developing environmental and human health safety standards for
genetically engineered products6. Our collaborations with a diverse range
of stakeholders and responsible observers have demonstrated that public
concerns about the risks of biotechnology can be addressed through such a
participatory and open process to make safety a first priority in the
development of biotechnological products. As a result, this Initiative is
building a rare and extraordinary convergence among previously
acrimonious parties in the agricultural biotechnology debate.

The genetic engineering industry, operating in different social and
ecological contexts around the world, has yet to take the lead in
establishing comprehensive and proactive cross-industry safety standards.
Instead, biosafety governance has largely involved a reactive approach
that places the burden on government or consumers to demonstrate safety
or risk just before or after commercialization; that is, ten or more
years after a firm has committed to developing a product. In the United
States, for instance, the government's focus on assessing risks (where
government regulation of commercial products exists) occurs long after
completion of multiple steps of design and development of a GM organism.
Waiting until this late stage to thoroughly address safety issues
increases vulnerability to regulatory disapproval, consumer jitters and
flawed decisions. Furthermore, scientific and governmental groups are
only beginning to devise scientifically informed standards for acceptable
risks, validation of scientific information related to risks and training
for safe management of biotechnologies7-12. Meanwhile, products that are
arriving from the 'next stage' of genetic engineering efforts, such as
growth-enhanced fish and pharmaceutical-producing crops, are presenting
daunting new challenges to food and environmental safety regulatory
regimes for both industry and government11, 13.


Elements of the 'Safety First' approach

There is a long history of efforts to improve safety within established
industries, such as the steel, railroad and aircraft manufacturing
industries, which have shaped the safety engineering profession14, 15.
Numerous industries eventually established industry-wide safety programs
to strengthen their inadequate safety records and thus earn consumer
confidence, reduce litigation and insurance costs, and assure business
viability. For example, in the aircraft industry, actions taken by cross-
representational groups over 30 years, and especially over the past 10
years, have resulted in safety improvements; the process was a
transparent, respectful one of improving safety programs and
incorporating the consensual standards into government regulations. In
this case, an analytic-deliberative process of decision-making has
evolved whereby potentially affected parties in the private and public
sectors collectively identify key safety issues to be addressed16, which
in turn has produced knowledge and agreements about safety that met and
moved beyond scientific 'reliability' to 'socially robust' and publicly
credible arrangements17.

The Safety First Initiative executive advisory board and steering
committee are now forming cross-sectoral working groups that will conduct
transparent negotiations to produce four categories of cross-industry
safety standards. The Initiative will begin by focusing on the safety
issues for two classes of products that are currently under development:
nonfood uses of food crops (e.g., genetically modified to produce
pharmaceutical and industrial compounds) and food uses of genetically
engineered fish and other aquatic species. Concerns about the
environmental and human health safety, and related regulatory complexity,
of these two classes of GM products have been an increasing focus of
discussion for scientists, policy makers, developers and consumers. These
products clearly promise benefits to a large number of consumers, while
posing new and complex safety management issues - a situation that
highlights the urgency for addressing the formulation of safety standards
in these two cases.

On the basis of lessons learned in the formation of successful industry-
wide safety programs, these working groups will negotiate and draft four
elements of cross-industry safety standards necessary to establish
credible safety planning and management for these two cases6:

Safety criteria setting.
Designing safety criteria requires systematic analysis of possible harm,
which involves the rigorous identification of hazards, the assessment of
risk and planning to reduce and control risk. Establishing a complete and
scientifically reliable set of safety design criteria for a product rests
on two requirements: establishing rigorous criteria at the outset of
development of a new product and independently validating these criteria
before they are used. Both of these tasks become at once doable and
highly credible when developers have an agreed-upon set of safety
standards to start from. Safety criteria developed for a product from
such safety standards might address such factors as the effects that
release of the GM product would have on the abundance of wild relatives
and nontarget organisms, and the allergenicity of foods derived from the
GM product.

Safety verification.
Rigorous tests need to be designed that will fully challenge the product
and credibly demonstrate that the product meets the pre-set and
government-approved safety criteria established in this process.
Designing these tests requires the application of the best available
scientific methodologies and information, from all relevant fields.
Standards might address, for example, acceptable means of verification of
the fitness of GM plants and fish compared with unmodified relatives.

Follow-up.
The processes of setting criteria and conducting tests to verify that the
product meets safety criteria cannot anticipate all problems. Open-minded
and scrupulous monitoring of the product in all its uses is also
required; the discovery of problems needs to be followed up with
meaningful and timely corrective action. Standards might address risk-
relevant monitoring and appropriate sampling of products in use.

Safety leadership.
A well-designed set of safety criteria, verification processes and
follow-up procedures will only be meaningful if they are implemented
consistently and properly. This requires responsive and responsible
safety leadership in three areas. The first area is the establishment of
rigorously trained and independently certified safety engineers who would
be valued employees of firms and government agencies. The second area is
the encouragement of a company management style that fosters broad
thinking, application of the best scientific methodologies and
information, self-imposed responsibility to make safe products,
responsiveness to evidence of real hazards and problems, and independent
review of all aspects of the product safety program. The third area is
the creation of a framework for managing the application of cross-
industry safety standards, including an independent audit function.

The above four elements offer a means for galvanizing national and
international participants from biotechnology firms, agriculture and
aquaculture, food processing and retail firms, consumer and other public
interest groups, academia, and government to organize and build on their
existing knowledge and practices to establish scientifically reliable and
publicly credible safety standards that would be applied throughout the
research, development and commercialization processes for these two cases
of GM products.


Shared benefits, shared responsibilities

The Safety First Initiative can offer benefits to many groups
simultaneously. Safety principles, applied early in the design process,
can benefit multiple stakeholders concerned with environmental safety,
food safety and the security of their investments. For an example of
building safety into early stages of design and development, consider
Davison's18 proposals to enhance biosafety of recombinant microorganisms
through the removal of unwanted genes, by increasing the stability of
gene constructs, through inducing suicide in transgene hosts and in the
use of "environmentally friendly genetic markers" in GM organisms.
Consensual safety standards, developed by integrating ideas such as
these, would work to improve biosafety management, and they would have
other benefits, such as enhanced market competitiveness, higher
investment ratings and an improvement in inter- and intra-industry relations.

Establishing these cross-industry safety standards would draw on existing
national and transnational regulatory regimes but also would require
industry leadership. Other industries, such as aircraft and steel,
demonstrate that individual firms can be safety pioneers. Today, some
life science companies that use genetic engineering have already
established some components of a safety program and offer the foundation
for building a cross-industry program. For instance, a consortium of
safety experts from a variety of companies are informally organized
around an effort to improve safety programs across the agricultural
biotechnology industry, focused on pharmaceutical crops, in an effort
supported by the Biotechnology Industry Organization (Washington, DC,
USA). Some companies, such as Dow AgroSciences (Indianapolis, IN, USA)
and DuPont (Wilmington, DE, USA) are applying safety management programs
developed in their pharmaceutical and chemical divisions to safety
management of biotechnology products. Pioneering firms have not received
appropriate recognition for their efforts because the efforts are
undertaken in isolation rather than industry-wide, are implemented
partially and are not vetted by independent, cross-representational
groups. Smyth et al.5 emphasized that the industries involved with GM
products stand to gain from decreased risks of product failure and
liability claims. To achieve these benefits, it is essential that the
biotechnology industry develop private-sector safety governance regimes,
from firm-level components, such as product safety verification, to
cross-industry components, such as third-party certification of
biotechnology safety engineers, as other industries have done.

The Safety First initiative also involves the kind of representative,
independent and verifiable process that would be credible with consumers
and other groups, a credibility that has eluded those biotechnology
companies, despite the extensive efforts of some to ensure safety.
Involvement of scientists and safety experts from multiple disciplines in
the working groups that will draft the safety standards will ensure that
industry safety programs are also scientifically reliable. Existing
lessons suggest that the development of such effective, responsive and
responsible safety standards can improve the trust of the public and
affected industries (e.g., food retail businesses) in genetic engineering
and other biotechnologies.

In addition, the initiative also offers a process for national and
international government units to make constructive progress toward
addressing the gaps in the patchy nature of biosafety governance
globally. New, government-certified, biotechnology-safety engineer
training programs aimed at building a recognized safety professional
career path would provide additional reassurance.

In proposing cross-industry safety standards for genetic engineering
through the Safety First Initiative, we are well aware that safety
failures in particular applications of GM organisms will still occur due
to complex interactions among people's behavior, the technology, human
social institutions and environmental factors. GM organisms are
themselves complex, their potential interactions with and effects on the
environment and human health are diverse and complex, and their present-
day management - from the idea stage to final use - involves diffuse
leadership and responsibility. Safety standards will necessarily be
applied in a global economic context, and it will be a challenge to
design their content and operation to be effective in different social
and ecological settings without exacerbating existing disparities between
nations in their capacities to govern genetic engineering. Acknowledging
these complexities while focusing on making safety the first priority
will require integrity, pragmatism and wide participation6. The first
step is replacing the current retrospective risk-based paradigm for
governing biotechnology with a proactive safety paradigm.


REFERENCES

1. Johnson, B. & Dallimore, R. Nat. Biotechnol. 20, 871 (2002)
2. Editor. Nat. Biotechnol. 20, 527 (2002)
3. Shubert, D. Nat. Biotechnol. 20, 969 (2002)
4. Snow, A.A. Nat. Biotechnol. 20, 542 (2002)
5. Smyth, S., Khachatourians, G.G., & Phillips, P.W.B. Nat. Biotechnol.
20, 537-541 (2002)
6. Kapuscinski, A.R., Jacobs, L.R. & Pullins, E.E. (eds.). Safety first:
making it a reality for biotechnology products: final report of the April
22, 2002 workshop (Institute for Social, Economic and Ecological
Sustainability, University of Minnesota, Minneapolis, MN, 2002). http://
www.fw.umn.edu/isees/biotech/sfreport.pdf
7. Scientists' Working Group on Biosafety. Manual for Assessing
Ecological and Human Health Effects of Genetically Engineered Organisms
(Edmonds Inst., Edmonds, WA, 1998).
8. Letourneau, D.K. & Burrows, B.E. (eds.). Genetically Engineered
Organisms: Assessing Environmental and Human Health Effects (CRC Press,
New York, NY, 2001).
9. USDA ABRAC Working Group on Aquatic Biotechnology and Environmental
Safety. Performance standards for safely conducting research with
genetically modified fish and shellfish (USDA Office of Agricultural
Biotechnology document no. 95-2004, 95-2005, USDA, Washington, DC, 1995).
10. Committee on Genetically Modified Pest-Protected Plants. Genetically
modified pest-protected plants: science and regulation (National Research
Council, National Academy Press, Washington, DC, 2000).
11. Committee on Environmental Impacts Associated with Commercialization
of Transgenic Plants. Environmental effects of transgenic plants: the
scope and adequacy of regulation (National Research Council, National
Academy Press, Washington, DC, 2002).
12. Secretariat of the Convention on Biological Diversity. Cartagena
protocol on biosafety to the convention on biological diversity (Articles
15, 16 and Annex III) (UNEP, Montreal, ON, 2000).
13. Committee on Defining Science-Based Concerns Associated With Products
of Animal Biotechnology. Animal biotechnology: science-based concerns
(National Research Council, National Academy Press, Washington, DC, 2002).
14. Aldrich, M. Safety First: Technology, Labor and Business in the
Building of American Worker Safety 1870-1939 (The Johns Hopkins
University Press, Baltimore, MD, 1997).
15. Ruttan, V.W. Technology, Growth and Development (Oxford University
Press, New York, 2001).
16. Stern, P.C. & Fineberg, H.V. (eds.). Understanding Risk (National
Research Council, National Academy Press, Washington, DC, 1997).
17. Gibbons, M. Nature, 402, C81-C84 (1999)
18. Davison, J. Environ. Biosafety Res. 1, 9-18 (2002)


ACKNOWLEDGMENTS

This work was supported by the Pew Initiative on Food and Biotechnology,
the Pew Fellows Program on Marine Conservation and numerous colleges and
programs at the University of Minnesota.

 


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