Life Sciences

Based on current rates, U.S. government investment in life sciences research is likely to be only one quarter of China's on a per-GDP basis in the next five years.

Though life science is widely assumed to be a strong sector for the U.S., if current budget cuts continue, emerging nations such as China will overtake the U.S as the world's leader in this area. Policymakers must realize the importance of boosting public investments in life sciences for U.S. prosperity and international competitiveness and the tremendous societal value of advances in this area. We can and must avoid the peril of falling behind in this critical sector.

Biotech crops have grown on well over a billion hectares in more than 30 countries by nearly 17 million farmers.

We're at seven billion people and counting and we all need to eat. Fortunately, innovation in life sciences is helping meet this challenge. In recent decades, researchers discovered and illuminated the numerous mechanisms by which DNA is recombined in nature and learned how to use those techniques in the laboratory. As a consequence, crops improved through biotech have been grown by now on well over a billion hectares in more than 30 countries by nearly 17 million farmers, 15 million of whom are resource-poor smallholders in developing countries. Read more »

Confronting the Gordian Knot

March 8, 2012
| Blogs & Op-eds

An array of approaches is becoming available for manipulating the genetic content of plants and animals. Such approaches are gaining attention from regulators, particularly in Europe, where the question is whether new technologies should fall under the same restrictive regulatory framework as plants modified using the traditional transgenic approaches. This is of central importance because restrictive European regulations have not only had pernicious effects on applied plant science throughout Europe, but have also been a factor in the closure of major R&D facilities of European agrochemical companies. Even if legislative loopholes could be found that would allow biotech plant products produced by new technologies to move forward outside of existing regulations, the Gordian knot binding European plant science through continuing policy failure and political timidity will remain uncut.

The Convention on Biological Diversity, Biosafety Protocol Ad Hoc Technical Expert Group on Risk Assessment & Management: An Independent Review

February 8, 2012
| Reports

An Ad Hoc Technical Experts Group (AHTEG) on risk assessment and risk management was established by the Conference of the Parties to the Cartagena Protocol on Biosafety (Biosafety Protocol), a subsidiary agreement under the Convention on Biological Diversity at the 4th Meeting of the Parties (MOP) in 2008. The AHTEG was tasked with providing assistance to Parties in risk assessment and management, and the mandate instructed the AHTEG to meet twice prior to the fifth Meeting of the Parties (MOP).

In the first meeting, in April 2009, the AHTEG was directed to “[d]evelop a ‘Roadmap’, such as a flowchart” to assist Parties conducting risk assessments according to Annex III of the Biosafety Protocol. The AHTEG was also instructed to consider the need for guidance on specific topics in risk assessment, produce modalities for the development of these documents, and prepare a report for review in the second meeting of the AHTEG. The intent was that this second meeting would review and finalize the “Roadmap” and: (1) make recommendations “on how to integrate the “Roadmap” and tools for retrieval of guidance materials”; (2) review the action plan concerning the modalities produced in the first meeting; (3) “consider possible modalities for cooperation in identifying living modified organisms that may have adverse effects”; and (4) prepare a report for MOP.

This paper examines the progress of the AHTEG toward a successful outcome by considering several questions: how did it operate; how did it consider input from AHTEG members and external experts; will the ongoing work produce a useful product? And importantly, is existing experience with risk assessment of LMOs being used? Information available to registered participants in the Open-ended Expert Group was used as well as relevant information publicly available on the Biosafety Protocol Secretariat’s website. Based on the stark divergence of positions apparent in those sources it seems unlikely that a credible path to a successful outcome from this AHTEG can be found by MOP-6 in October 2012, as mandated.

Genetically-Modified Papaya Hits Shelves in Japan

Voice of America
Major U.S., E.U. and international scientific advisory groups have agreed that today’s crop of GMOs do not pose a risk to health or the environment.

Feeding the Next Generation: Science, Business, and Public Policy

December 21, 2011
| Reports

Serving as an editor for the December 2011 edition of Science, Technology, and Globalization published by Harvard's Belfer Center for Science and International Affairs, Senior Fellow Val Giddings stresses in his introduction that as editors, academics, and practitioners in agricultural innovation, there should be a regonition that biotechnology and genetically modified crops remain controversial to some eyes, despite the robust safety and productivity record of GM crops currently on the market. He does not ask the readers of this volume to accept blindly the positions its authors advance, nor even the volume’s overall conclusion that genetically modified crops can and should play a critical role in agricultural productivity. The primary concern is that scientific findings and analysis remain the key driver of global agricultural research and policy, not manipulated popular opinion or perceptions. The following papers are grounded in that tradition, and offer a roadmap for those interested in objectively evaluating both the risk and benefits of biotechnology in agriculture.

The Office of Science and Technology Policy must have regulations based in science that should be frequently updated to take into account the lessons gained from experience.

Reform the U.S. regulatory system. Regulations must be based in science and should be frequently updated to take into account the lessons gained from experience. The system should not seek zero risk as this is unattainable in the real world. Regulatory review should seek to establish that novel products are as safe as others in the marketplace. In making this evaluation regulators must take into account both the harms caused by present practices as well as opportunity costs, the potential benefits that would be lost by non-adoption. The degree of regulation should be commensurate with real risks and harms.

Brazil has overtaken the United States among major agricultural exporters as having the shortest time for these products in the regulatory process.

Astounding advances in recent years in the natural sciences and biotechnology has put us at the dawn of a "bio-economy." Life-sustaining scientific advances and significant economic opportunities will go hand-and-glove in this economy. Unfortunately, U.S. regulatory policies are not keeping up with science and political leadership is needed to turn back ideological and unfounded fears about the risks associated with biotechnology and innovations in life sciences. Read more »

Testimony Before Boulder County Commission

December 8, 2011
| Testimony and Filings

On December 8, 2011, Senior Fellow Val Giddings presented testimony at a public hearing held by the Boulder County Commission, on a proposal to ban crops improved through biotechnology from being grown on approximately 17,000 acres of County green-space land. Boulder County has been a national leader in land use planning, and preserving Front Range green space for multiple uses has been a high priority from the beginning. Boulder is also a seething hotbed of devotion to organic foods and production techniques. The county is home to as many as six nationwide organic chains, one of which (Aurora Dairy) is reportedly the principal instigator and financial sponsor behind the drive to ban "GMOs" from County lands: a move that would be bad for the land, bad for people, and bad public policy.

ITIF Submission to the Office of Science & Technology Policy on "Building a 21st Century Bioeconomy"

December 6, 2011
| Testimony and Filings

Advances in life sciences are pivotal to the well-being of humankind and hold potentially vast economic benefits. In response to an Administration initiative to revise federal policies in this area, ITIF Senior Fellow Val Giddings urges policymakers to reform regulatory practices that are impeding the development of a sustainable, bio-based economy for the 21st century. In a submission filed with the Office of Science & Technology Policy (OSTP) he stresses regulations that do not address credible hazards must be retired, and regulatory oversight must be refocused on areas where risks might, in fact, reside and significant uncertainty remain. He outlined six specific steps for officials to take to ensure regulations better reflect the latest scientific data and promote the development and adoption of critical innovations in this area:

1) Reform the U.S. regulatory system. Regulations must be based in science and should be frequently updated to take into account the lessons gained from experience;

2) The trigger for regulatory review should be the novelty of the introduced trait (introduced by whatever method) and not the process used to introduce the trait;

3) Exempt phenotypes from regulatory review if they could be accomplished through classical breeding methods;

4) Regulatory agencies must stop treating gene flow as intrinsically hazardous, and shift their focus to appropriate risk management/mitigation in the rare cases where genes so disseminated could, in fact, present a genuine hazard;

5) Shift to phenotype-based regulatory triggers. Agencies should transition from an event-based regulatory process to a phenotype-based process, as the hazard of a phenotype that is stably inherited has more to do with the distinguishing features of the phenotype than with the precise details of the process through which it was produced;

6) Enhance effectiveness, adaptability, and public confidence by accelerating regulatory updates and transparency.