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CONTAMINATION & COEXISTENCE: U.S. BIO launches Excellence Through StewardshipSM Program




                                  PART 1


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TITLE:  BIO LAUNCHES EXCELLENCE THROUGH STEWARDSHIPSM PROGRAM

SOURCE: Biotechnology Industry Organization, USA

AUTHOR: Press Release

URL:    http://www.excellencethroughstewardship.org/press/newsitem.asp?id=2007_0725_01

DATE:   25.07.2007

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BIO LAUNCHES EXCELLENCE THROUGH STEWARDSHIPSM PROGRAM

Initiative Introduces Best Practices for Quality Management of Plant Biotechnology ProductsWASHINGTON, D.C. (July 25, 2007) — The Biotechnology Industry Organization (BIO) today launched a new program, Excellence Through Stewardship: Advancing Best Practices in Agricultural Biotechnology, the first industry-coordinated effort to address product stewardship and quality management.

Excellence Through Stewardship continues BIO’s commitment to enhancing regulatory compliance, and product quality for consumers. The program provides a strong quality management system for the full life cycle of biotech plants into the future. It is intended to promote the responsible management of agricultural biotechnology, the continued adoption of plant biotechnology globally, and the enhanced value of biotech-derived plant products in the marketplace.

”The agricultural biotechnology industry has a long history of promoting stewardship,” said Jim Greenwood, president and chief executive officer (CEO) of BIO. ”The Excellence Through Stewardship program continues BIO’s efforts to provide consistently high quality standards across the agricultural biotechnology industry in addressing product stewardship and quality management issues. Today’s announcement reflects BIO’s commitment to promote safety and trust in the world’s food supply and to support smooth trade transactions in the agricultural community.”

Excellence Through Stewardship was developed by BIO’s Food and Agriculture Section to address product stewardship and quality management for the full plant life cycle. The program’s three main components include:

- Adoption of quality management Principles and Management Practices for maintaining plant product integrity that outline the basic tenets of the Excellence Through Stewardship program.

- Publication of a Quality Management Program Guide for BIO member companies and others involved in agricultural biotechnology research and development to use in understanding and implementing their own best practices.

- Adoption of an independent, third-party Stewardship Audit Program designed to verify implementation of stewardship programs and confirm quality management systems and compliance with principles and management practices.

Participation in the stewardship program in encouraged for all companies and institutions involved in research, development and/or commercial activities for plant products including, but not limited to, commodity crops, specialty crops, energy crops, perennials, ornamentals, plant-made pharmaceuticals (PMPs) and plant-made industrials (PMIPs). Member companies of BIO’s Food and Agriculture Section are encouraged to self-certify adoption of stewardship principles and then undergo third-party audits of quality management practices.

”Although many companies already have quality management programs in place, the Excellence Through Stewardship program is the first industry-coordinated undertaking to meet today’s product stewardship challenges,” said Andrew Baum, president and CEO of SemBioSys, and Chairman of BIO’s Food and Agriculture Section Governing Body.

The Excellence Through Stewardship program is a global initiative that will be introduced in a three-phased approach. The biotech industry anticipates that the program will be rolled-out in the United States over the next 18 months, and will subsequently be extended globally within three years.

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world’s largest gathering of the biotechnology industry. Visit BIO at www.bio.org.



                                  PART 2

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TITLE:  FIRMS TAKE ON DO-IT-YOURSELF REGULATING

SOURCE: St. Louis Post-Dispatch, USA

AUTHOR: Rachel Melcer

URL:    http://www.stltoday.com/stltoday/business/stories.nsf/0/D888B2805DD1D3C186257324000A885C?OpenDocument

DATE:   26.07.2007

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FIRMS TAKE ON DO-IT-YOURSELF REGULATING

Biotech crop makers on Wednesday said they are increasing self-regulation to avoid the accidental spread of genetic material. These incidents can cost companies access to foreign markets, consumer confidence and big legal bills.

The Biotechnology Industry Organization, a Washington-based trade group, will design and administer the program, dubbed ”Excellence Through Stewardship.”

Member companies — including the world’s six largest providers of genetically modified seeds — will adopt quality management standards, then undergo independent third-party audits to verify compliance. The goal is to track and control genetic crop traits in research discovery, through field trials, marketing and eventual phaseout.

No one wants these genes to turn up in places they’re not supposed to be — such as last year’s surprise finding of unapproved LibertyLink genes in commercially available long-grain rice.

Regulators found the trait, developed by Bayer CropScience, was harmless and subsequently approved it for the market. But damage was done: Japan, the European Union and other countries closed to U.S. rice imports. Prices fell, then farmers suffered and filed a class-action lawsuit against Bayer in U.S. District Court in St. Louis.

”The industry is trying its best, in a world that’s not 100 percent perfect, to self-regulate and self-police because it’s in their best interest,” said Marshall Martin, associate director of agricultural research programs at Purdue University.

The stewardship program will roll out in three phases.

Companies will self-certify they have adopted the program in their domestic operations by early next year. At the end of next year, they will have completed audits by independent firms that are trained and certified by BIO, the industry organization. In 2009, BIO member companies will roll out the program to operations abroad.

”Part of our challenge will be — and we look forward to it — making sure that this is the gold standard and that it is understood around the world,” said BIO President and Chief Executive Jim Greenwood.

The initiative is not a reaction to the Bayer incident, he said. Rather, ”we see the science evolving, we see the use of these products expanding, and we felt our efforts should evolve as well.”

Andrew Baum, chairman of BIO’s Food and Agricultural Section Governing Body, said companies always have had quality management standards.

”It’s not as if (the Bayer incident) took place and we had an epiphany,” he said. ”We were moving towards this anyway.”

What’s more, the stewardship program should raise all boats by making the best practices of industry giants available to smaller companies, university researchers and players abroad, BIO said.

”I wish, when we had five employees, we had something like this. It would have saved us a lot of time and effort,” said Baum, president and CEO of SemBioSys Inc., a 70-person plant-based pharmaceutical firm in Calgary, Alberta.

The acid test for this program will be acceptance by stakeholders, such as venture funds that can’t afford to risk investments in firms that might implode by having a technology ”leak,” he said.

BIO presented its program to the U.S. Department of Agriculture, Environmental Protection Agency, and Food and Drug Administration — all of which regulate biotech crops.

The federal agencies do not have this type of quality management and stewardship regulation in place — but ag biotech companies say they are not trying to step on government toes.

”The industry supports strong, science-based federal regulation. This is a complement to that, it’s not a substitute. Both are really important,” said Jerry Steiner, an executive vice president with Creve Coeur-based Monsanto Co., the industry leader.

Participants hope the program will stave off future leaks of biotech traits into conventional crops, which damage consumer acceptance of their products. It’s a pivotal time for the industry, as it nears commercialization of a generation of crops engineered with traits that add consumer benefits — healthy-oil and omega-3 enriched soybeans, for example. Shoppers need to trust the safety of the technology for these to succeed.

”I don’t think anyone can say this will prevent any particular incident,” said Tom West, a vice president with DuPont unit Pioneer Hi-Bred International Inc. ”But this is about raising standards all across the board.”


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