Seed World

Regulatory Roundup Dec 2010


ASTA Updates Quality Management Guide

The Guide to Seed Quality Management is an educational tool providing general guidance to assist companies in developing and implementing quality management systems. The guide provides information for maintaining seed product integrity from incorporation of a trait into a breeding program through commercial seed production and sale. “The original guide, released in 2008, was well received by the seed industry,” says Ric Dunkle, ASTA senior director of seed health and trade. “When we released it, people began looking at it and coming back to us with recommendations, which have been taken into consideration in the new version.”

“The previous version focused on quality management systems for maintaining genetic integrity,” says Bernice Slutsky, ASTA vice president for science and international affairs. “The addition of phytosanitary information integrity really completes the guide.” The guide consists of eight modules covering everything from incorporating seed into a breeding program to commercial seed sales. It also provides users with a list of terms and acronyms, resources, general auditing principles and an International Standard Organization.

Accreditation of COFA Revoked

The United States Department of Agriculture has announced that the California Organic Farmers Association’s accreditation as an organic certifying agent has been revoked. As a result, COFA is no longer authorized by USDA’s National Organic Program to certify organic crop, livestock, wild crop and handling operations. Once accredited, organizations must renew their accreditation every fi ve years. The NOP accredited COFA as an organic certifying agent on April 29, 2002. Following COFA’s submission of a fi ve-year renewal application in 2007, the NOP conducted an audit of the facility and its records, which resulted in the finding of 12 non-compliant items. After COFA submitted corrective actions, the NOP determined COFA had not adequately corrected 10 of the non-compliances. Pursuant to federal regulations, COFA requested a formal administrative proceeding before an administrative law judge. In August 2010, COFA withdrew its request for a hearing, thereby upholding the administrator’s denial of COFA’s appeal and revoking COFA’s accreditation for three years.


CropLife International Enforces the “Compact”

CropLife International has announced that the Compact, a clearly defi ned, effi cient and fair process for countries to file and process claims related to damage to biological diversity caused by living modified organisms, is now in force. Members of the Compact include the six major plant biotechnology providers: BASF, Bayer CropScience, Dow AgroSciences, DuPont, Monsanto and Syngenta. “The plant science industry’s commitment to stewardship and the responsible development and use of living modified organisms has helped ensure there has been no negative impact on biological diversity for over 15 years of commercialization,” says Denise Dewar, executive director of plant biotechnology at CropLife International. Since 2008, the Compact’s founding members have developed the framework and guidelines for fi ling and arbitrating claims.

New Royalty Scheme and IP Office Opens in United Kingdom

The Breeders Intellectual Property Offi ce Ltd. has been established to collect royalties on behalf of breeders who use a royalty area collection approach in the United Kingdom. In its third season, RAC is a contract-based approach to the management and collection of royalties. Initially, this is operating in some minor crop areas but the prospect is there for a wider adoption. The scheme adopts a unifi ed royalty approach on the basis that regardless of whether the seed is farm-saved seed or certifi ed, the genetic expression remains the same. Supported by dedicated software, royalties are invoiced directly by BIPO to the grower on the area established. The retained information provides a data bank for traceability from season to season and for audit verifi cation. In adopting an area payment approach, it is believed both growers and stakeholders will better appreciate the genetic value being delivered through new improved varieties. The RAC system can also have its place with novel trait varieties where a more dynamic relationship can be established between the breeder and grower.

European Union Policy on Plant Health

The European Commission, represented by Commissioner John Dalli, and the Belgian EU Presidency, represented by Minister Sabine Laruelle, hosted a recent conference in Brussels on the future of the European Union’s legislationon plant health. The conference marked the end of the first step of the evaluation of the existing legislation and presented conclusions as well as options and recommendations for a future revision. Dalli underlined the main objective of EU plant health legislation, the protection of the safety of food derived from plants and to secure the health and quality status of crops in all member states by regulating the trade of plants and plant products within the EU as well as imports from the rest of the world in accordance with international plant health standards and obligations. Dalli and Laruelle stressed the importance of this policy and the fact that, in view of climate change and increasing world trade, more will need to be done in the future. At the same time, both pointed out the limited  resources available and the importance to involve all capacities on the European and national levels to achieve the objectives. The commission invited stakeholders to supply further input to the process in the coming weeks and months, during which an action plan and, fi nally, a legislative proposal will be developed and placed before the European Parliament and member states for final discussion and decision.

Origin Agritech Reaches Bt Agreement

Origin Biotechnology, a subsidiary of Origin Agritech Limited, has reached a comprehensive, worldwide agreement with the  Institute of Plant Protection, Chinese Academy of Agricultural Sciences. CAAS jointly owns the rights to the internally developed Bt gene. Origin Biotechnology already possesses the rights to this genetic trait in domestic China and has been passing this product through the Ministry of Agriculture regulatory trials. This particular Bt gene, demonstrated to be effective in both laboratory and field environments, is novel to consumer markets in that it has never been commercialized and is protected by patents granted separately by China and the United States. For the life of the patent, Origin will possess exclusive rights to sell and develop field crop products containing these technology traits worldwide. Origin will also receive exclusive rights to sub-license to any third parties to develop seed products containing these traits.

Turkish Biosafety Law Enters into Full Power

The Turkish Biosafety Law entered into full force. This means any use of GMOs in Turkey is illegal including using stocks of GM soybean intended for feed use in the poultry and meat industry. The impact on socioeconomics and poultry, dairy and meat prices is unpredictable. The Black Sea Biotechnology Association will follow the situation.

Monsanto Achieves Latin American Approvals

Corn and soybean farmers in Latin America are one step closer to planting improved next-generation technologies. Monsanto Company has secured two new approvals in Latin America: Genuity VT Triple PRO corn in Argentina and Bt Roundup Ready 2 Yield soybeans in Brazil. In Argentina, the company received full regulatory approval for Genuity VT Triple PRO corn, which represents the first Genuity trait launched from Monsanto in South America. The next and last step prior to commercialization is hybrid registration, which the company
expects to complete by the end of the year. In Brazil, Monsanto also received full regulatory approval for insectprotected and glyphosate-tolerant BtRR2Y soybeans from theNational Technical Biosafety Committee. The BtRR2Y soybean  represents the first trait the company has developed specifically for a market outside the United States and the only soybean to combine Bt insect-protection technology with herbicide tolerance. BtRR2Y soybeans will be introduced in Brazil after import approvals in important markets are secured.