Commitment to Field Trial Compliance

Overview

Field trials are an important component of the development of all new seed varieties, including GMO crops. Testing GMO products in regulated field trials is vital to develop important scientific information, to assess the performance of a new trait, and to generate the necessary environmental safety data required by regulatory authorities that evaluate commercial product approvals.

Seed companies, universities, foundations and government agencies, such as the U.S Department of Agriculture (USDA), conduct field trials. In recent years, USDA has authorized more than 80 entities to conduct GMO field trials. USDA’s Animal and Plant Health Inspection Service (APHIS) publishes this information at the Biotechnology Regulatory Services page on its website. Throughout field trial evaluations, GMO crops are subject to strict regulatory oversight.

 

Field Trial Process

Regardless of scale, all U.S. field trials on GMO traits must adhere to safety and performance standards from APHIS. The standards are designed to prevent unintended introduction of GMO crops into commerce or the environment. Information about APHIS requirements for field trials is published in the Code of Federal Regulations.

Field testing of GMO crops is conducted in phases. Testing typically begins with a small number of plants and expands as more information is obtained. Developers conduct initial screening and plant selections in laboratory and greenhouse facilities that meet or exceed APHIS specifications. With this data, developers request authorization from APHIS to conduct isolated small-scale field trials. Results from small-scale field trials are used to further screen and select those plants to be tested in larger field trials.

 

Mandatory Compliance

APHIS posts notices of what it determines to be major instances of non-compliance on its website. These are quite rare. In recent years, APHIS has reported that the compliance rate for regulated GMO field trials, validated by inspections, is about 99 percent. APHIS also reported that most instances of non-compliance are minor infractions. Together, USDA’s regulatory requirements and industry’s stewardship practices have proved to be a very effective combination.

 

Voluntary Compliance

In addition to these mandatory compliance standards, APHIS offers a voluntary comprehensive quality management program, the Biotechnology Quality Management Support Program (BQMS), for entities who conduct field trials. The BQMS Program is designed to help organizations of any size (university, small businesses, and large organizations) develop sound quality management practices to enhance their ability to comply with the APHIS regulations governing GMO traits.   The BQMS Program is a modular system which allows each unique user the option to create a documented self-certifying quality management system to manage critical control points of working with GMO traits.  In addition to BQMS, a stewardship and quality management program for GMO products, Excellence Through Stewardship, has also been developed by agricultural companies. Several entities who conduct field trials participate in both programs.

 

Monsanto’s Field Trial Program

Monsanto is a founding member of the Excellence Through Stewardship program, participates voluntarily in BQMS, and has an industry-leading field trial compliance program designed to meet or exceed APHIS compliance standards for every Monsanto field trial.  Since 1990, Monsanto has conducted over 31,000 trials in the United States. These trials are conducted by our own staff as well as qualified private contractors, universities and farmers. We take field trial compliance very seriously and make compliance our top priority.

Adhering to APHIS compliance standards is the starting point for our field trial compliance program. Monsanto implements additional procedures to achieve the highest level of compliance:

  • Comprehensive training for those who conduct field trials and for all those responsible for field-site compliance.
  • Extensive procedures for all field personal involved in trial work.
  • Documentation of critical control points for each trial.
  • Proactive auditing to verify compliance with internal and external standards and to identify process improvement opportunities.

Monsanto is committed to meeting or exceeding all government regulations governing our field trials. We have embraced proactive auditing and self-reporting to encourage employees and cooperators to identify and immediately report incidents of potential non-compliance. While we believe that our compliance program is among the most comprehensive and successful compliance programs in the industry, we continually review and strengthen our practices.

 

Monsanto’s Compliance Record

Monsanto has been performing field trials with GMO crops for more than 20 years. We do experience occasional deviations from internal and APHIS standards, which we work continuously to eliminate. A profile of our compliance record includes:

  • Monsanto has conducted more than 31,000 regulated trait field trials.
  • To date, Monsanto’s total self reported incidents represent less than 1 percent of Monsanto’s total field trials.
  • Since 2000, Monsanto has self-reported to APHIS 299 instances of potential non-compliance with our internal processes, procedures and standards.
  • The majority of these reported incidents have been administrative, corrected quickly and not associated with any release into commerce or persistence in the environment.
  • 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 took remedial measures to re-establish containment and prevent persistence in the environment. In these cases, the appropriate agencies have never concluded there were environmental or health concerns.

The overall low ratio of APHIS determinations of non-compliance to Monsanto field trials conducted demonstrates that Monsanto’s compliance program has resulted in a high volume of successfully managed field trials.

USDA’s field trial program oversight has been effective in preventing GMO traits that are being field tested from escaping or persisting in the broader environment. Monsanto is committed to meeting or exceeding all government regulations governing field trials, and we self-report potential compliance deviations. This combination of comprehensive regulatory oversight and voluntary programs to build, maintain, and independently verify quality management systems has been extremely effective in preventing the unintended release of GMO crops into commerce or the environment.

 

Updated March 2017