"We are committed to the continual development of a regulatory framework that reflects the latest science and information so that we can maintain the integrity of our systems," says Bobby Acord, APHIS administrator. "These new conditions are science based and reflect the anticipated increase of requests for permits for plants genetically engineered to produce pharmaceutical and industrial compounds."
The new conditions included in a Federal Register notice include:
· An increase in the number of field site inspections to assure compliance with the regulations and assigned permit conditions. Every test site will be inspected more than once and inspections would correspond to critical times in production. A sample inspection plan might be five site visits made during the growing season, and another two for assessing volunteer plants the following year;
· Permit conditions specifically for corn designed to produce pharmaceutical and industrial compounds such as a requirement that no corn be grown within one mile of a field test site that involves open-pollinated corn;
· A restriction on the production of food and feed crops at the field test site and perimeter fallow zone in the following season;
· The use of dedicated mechanized equipment used for planting and harvesting as well as dedicated facilities for the storage of equipment and regulated articles for the duration of the field test;
· A requirement that equipment cleaning procedures be submitted and approved by APHIS to minimize the risk of seed movement;
· A requirement that seed cleaning and drying procedures be submitted and approved;
· The implementation of a training program to ensure that personnel are prepared to successfully implement and comply with permit conditions; and
· An increase in the size of the perimeter fallow zone (an area not in production) around the field test site from 25 to 50 feet.
In addition to these changes, APHIS is seeking comment on three biotechnology issues: (1) What additional measures can APHIS take or employ to increase transparency and enhance the flow of information to interested parties and the public? (2) What alternative procedures, including the scientific data and technical rationale on which these alternative procedures are based, could be used for ensuring adequate confinement for field tests? and (3) What methods or approaches should APHIS utilize to ensure compliance? These measures could be appropriate training standards, the use of third-party auditors, standard-setting organizations, or other quality control mechanisms to monitor and ensure compliance.
"We will continue to build enhancements and redundancies into the system to ensure that it is keeping pace with technology," Acord says. "Because plants engineered to produce industrials and pharmaceuticals "are not meant" to enter the food supply, we believe a very stringent system is called for. We will lead a public dialogue on this issue as well as issue new regulations in the coming months."
For example, Acord says it is the intention of the agency to publish an interim final rule that will require a permit for the field testing of industrials for the 2003 growing season. Until the rule is published, APHIS will strongly encourage applicants to request a permit for field testing industrials.
Notice of this action was scheduled for publication in the March 10 Federal Register. APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available at http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Consideration will be given to comments received on or before May 9. Comments may be submitted by postal mail, commercial delivery or by e-mail. Send an original and three copies of postal or commercial delivery comments to: Docket No. 03-031-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road, Unit 118, Riverdale, Md. 20737-1238.