Company highlights commitment to compliance, preventive auditing and self-reporting

In reference to the U.S. Department of Agriculture's (USDA) recent release of information on field trials conducted with crops developed through plant biotechnology, Monsanto Company today released information on the company's field trial testing program and our commitment to compliance.

"As a leader in the field of plant biotechnology, we are committed to making sure that every field trial we conduct is in full compliance with all applicable regulatory requirements," said Jerry Hjelle, PhD., Vice President of Monsanto's Regulatory Affairs organization.

"We believe that we have established one of the most comprehensive and successful compliance programs in the industry, which we continually review and strengthen in order to maintain the most effective program possible."

In 1999, Monsanto augmented its ongoing compliance program to include preventive auditing and self-reporting, which encourages employees and cooperators to systematically identify and report incidents of potential non- compliance.

"We've done with our compliance program what many manufacturing organizations have done in the past two decades with safety initiatives -- made compliant, systematic field testing the responsibility of every individual in our organization who is involved in the conduct of these trials," said Hjelle.

"As a result, we've established what we believe is a model program that enables Monsanto to continue to bring forward products that demonstrate the great potential benefits of biotechnology in a responsible manner."

The company has provided access to information about Monsanto's field trial testing program for regulated crop varieties that contain biotechnology traits, including information on compliance related initiatives and results. Available online at www.monsanto.com , the key conclusions from the information are:

• Prior to the start of any regulated field trial with a crop containing a biotechnology-derived trait, Monsanto must obtain authorization from the USDA.
• Monsanto has conducted in excess of 12,000 regulated field trials since 1990, significantly more field trials than any other single company or institution.
• Monsanto has in place an industry-benchmark field trial compliance assurance program.  We have established and implemented a self-reporting system to reinforce compliance and continue to improve our systems and processes to prevent any potential environmental release of regulated material.
• Monsanto also has established a preventive auditing program, which encourages employees and cooperators to systematically identify and report incidents of potential non-compliance.
• To date, Monsanto is aware of 44 compliance infractions in our overall field trial program, six of which were referred to APHIS' Investigative and Enforcement Services for further review.
• Thirty-three of these infractions, or 76 percent, were identified through Monsanto's preventive auditing system and self-reported to APHIS.
• The total infractions represent approximately 0.4 percent of Monsanto's total field sites.
• In the rare cases where there was a potential for a loss of containment at a field trial site, Monsanto immediately notified the appropriate agencies and remedied the situation.  In these cases, the appropriate agencies examined the situation and determined that there were no environmental or health concerns.
• We have experienced a low rate of administrative and non-release infractions.  The majority of these infractions were minor, corrected quickly and were not associated at all with any release into commerce.
• The overall low ratio of infractions to trials conducted demonstrates that, as a whole, Monsanto's compliance program allows for a high volume of successfully managed field trials.
• As a member of the Biotechnology Industry Organization, Monsanto has worked closely with the biotechnology industry to implement inclusive and comprehensive training sessions that will further refine field testing procedures and enhance compliance with the regulations governing field tests with biotechnology-derived crops.

Monsanto Company is a leading global provider of technology-based solutions and agricultural products that improve farm productivity and food quality.