NDAES Biotech Research Policy
Executive Summary
Statement and Policies on Research and Development of Transgenic Organisms for North Dakota
The purpose of the North Dakota Agricultural Experiment Station (NDAES) is to develop and disseminate technology important to the production and utilization of food, feed, and fuel from crop and livestock enterprises. The pursuit of new technologies, including biotechnology, for enhancing farming, food quality and the environment is consistent with this purpose and will enable North Dakota to participate in the benefits of current and future technological innovations.
New and improved seed varieties are also developed by the NDAES. These crop breeding programs often utilize technologies such as hybridization, mutagenesis, plant tissue and cell culture, and biotechnology in order to develop varieties with the greatest net gains. The NDSU Seedstocks Project has direct responsibility for foundation seed propagation and the increase of these new varieties.
While the NDAES pursues research and crop breeding utilizing new technologies, including biotechnology, it recognizes that producers and consumers continue to want choices of what food products to purchase and what agricultural production and marketing systems to use. The NDAES recognizes that some production and marketing systems have not embraced biotechnology. Therefore, research and new variety development that benefit both biotech and non-biotech crop production and marketing systems will be pursued.
The NDAES's Statement and Policies on Research and Development of Transgenic Organisms for North Dakota describes how biotech research will be conducted and provides insight to the decision-making process related to biotech research. This policy is intended to guide NDSU scientists as they pursue biotech research and provide the public with information on how this work is conducted.
Key Points
Under the key points of this policy, the NDAES will:
- Continue to pursue new technologies for enhancing farming, food quality and the environment.
- Promote the coexistence of various production and marketing systems.
- Continue to develop genetically improved and environmentally adapted crops.
- Manage the development and propagation of new varieties to insure the availability of pure seed to the fullest extent possible. Follow research protocols that exceed APHIS standards when field testing regulated biotech crop material.
- Follow the National Institute of Health guidelines for containment facilities for the biotech materials.
- Have the NDSU Institutional Biosafety Committee give additional oversight to the approval process for testing regulated biotech material.
- Continue to utilize public variety release meetings for reviewing plant material considered for commercial release.
- Require regulated biotech research projects be pre-approved by the NDAES director and all non-regulated biotech research communicated to the director prior to planting.
- Require that policies regarding biotech research at all NDAES locations be established by the NDAES director.
NDSU policies on biotech research do not supersede established rules. However, they may be more restrictive or precautionary. NDSU policy and procedures provide protections consistent with its land-grant mission and to protect public interest.
Part 1. Authorities and General Understanding
Preface
The following document provides both a synopsis of information sources, and a policy under which transgenic research will be conducted at the North Dakota Agricultural Experiment Station (NDAES), and outlines steps that protect public interests during research on transgenic crop research. It also indicates controlling authorities, thereby providing insight on decision-making processes. This document provides an overall framework for agricultural research and extension work involving transgenic organisms undertaken by North Dakota State University. Research protocols for specific transgenic crops will be addressed in subsequent documents.
NDSU is signatory to a letter to the heads of EPA, FDA, NIH, and Secretaries of Agriculture and Health and Human Services (March 3, 2000) that says-in part, "There is an immediate and critical need for accurate information both on food production systems that have provided the American consumer with a diversified and healthful food supply, and on the role new technologies have played in food production and how they have been managed over the past century of American agriculture. It is only based in this context that consumers, legislators, and other decision makers can make sense of the often sensational risk and benefit claims reported by the media. A coordinated public information effort undertaken jointly by the federal government and our institutions will lay the foundation for sound decision making. More important, it will help protect against policy making by headlines and ensure that American food production systems are able to continue to pursue the most effective and safe new technologies for enhancing farming, food quality, and the environment." NDSU Agriculture believes that both producers and consumers continue to want choices. Choices of what food products to purchase and what agricultural production systems to utilize. Consequently, the NDAES and the NDSU Extension Service are encouraging a coexistence approach to organic, non-transgenic and transgenic crop production.
Part 2. Policies Regarding Specific Crops
North Dakota Agricultural Experiment Station Policy
The NDAES proposes the following as policy regarding regulated transgenic wheat. This policy may change if and when transgenic wheat becomes deregulated:
- The Foundation Seedstocks Director (FSD) is responsible for knowing, and mapping NDSU locations of transgenic wheat research and seed increase plantings, and verifying the locations each year of all REC on-station and off-station tests. The FSD will also collaborate with the ND Department of Agriculture in assuring as much as possible that any other tests, including private tests/increases of transgenic wheat will not be located so as to practically impact the production of foundation class wheat seeds.
- Unless specifically authorized by the Director of the NDAES, transgenic wheat will not be grown, tested, or increased on the Agronomy Seed Farm land.
- Transgenic materials, grown under the auspices of NDAES researchers, may be located at any of the RECs (or locations controlled by the RECs), the Dalrymple Experimental Plots near Casselton, AES lands near Prosper, and on the research land associated with the main campus in Fargo.
- Transgenic wheat must be separated from all other spring wheat or triticale by a distance of at least 330 feet, if adjacent wheat or triticale are research trials from which the grain will be retained as seed, or for commercial sale. Any wheat or triticale research trial within 330 feet of transgenic wheat will be destroyed on the site.
- Transgenic wheat must be separated from other crops (non- wheat or triticale) by a distance of at least 20 feet.
- Wheats with different transgenic traits may be evaluated in the same research trials without the requirement that any distance separate the plots if the resulting seed from these trials is retained for next year's research trials. However, if seed is intended for developing foundation seed, 330 feet should separate the trials that involve different transgenic traits from each other.
- If introduced and established in North Dakota, jointed goatgrass (Aegilops sp.), a weed species that can hybridize with wheat, must be eliminated from the area around the plots for a distance of at least 330 ft. Jointed goatgrass is not presently found in North Dakota.
- Equipment used to plant and harvest transgenic wheat must be completely cleaned of all seeds and other plant parts within the planted area before reuse. Dedicated equipment, including an identified planter, an identified combine, and seed cleaner provided by Plant Sciences Department will be used exclusively for planting, harvest, and initial cleaning of transgenic wheat involved in the breeding or foundation seedstocks program. Harvested seeds will be cleaned within the field plot area with a generator-powered air-screen cleaner that will be used exclusively for transgenic wheat.
- If measurements are not taken in the field, recovered cleaned seeds will be securely double bagged or double boxed to prevent loss, then returned to NDSU for measurements.
- Transgenic seeds at NDSU will be kept in a locked room with security and monitoring at the BL1 or BL1-P level (See NIH Guidelines III-E-3). All seed-borne crop debris, residue, and excess seed will be destroyed by autoclaving or incineration. Non-transgenic check varieties grown for comparison and not destined for subsequent scientific tests will be treated as if they are transgenic. Any seed associated with the study will not be allowed to enter commerce as a food or feed product. Also, seeds of known or suspected transgenic wheat retained for scientific tests and/or incorporation into new lines will be clearly labeled and segregated, and will not be stored, increased, or processed in ways that would increase the probability for admixture with non-transgenic lines.
- All parts of the transgenic field-grown plants, including clean-out seeds, must be destroyed on site. In harvested plots, residue must be tilled immediately to bury residue so that volunteers are unlikely.
- Any plot with transgenic wheat(s) and, in addition, any land within 100 feet of such a plot, must not be replanted into any non-transgenic wheat for two years following planting of the transgenic crop; provided the materials in the transgenic trial are hand-harvested or harvested with small-plot machinery as described in Sections H, I and J. If transgenic wheat plots are sufficiently large that they are harvested with commercial combines, the risk from seed scatter is greater and the isolation area surrounding the plot will be increased to 330 feet. wide. The plots with the additional 100 feet or 330 feet-wide isolation area must have corners: 1) established by GPS coordinates, 2) recorded, 3) marked with field flags, and 4) be monitored for any volunteers. If volunteers are found the second year, monitoring/elimination may be extended. Cropping with small grains that would make finding volunteers difficult should be avoided. Wheat volunteers must be destroyed prior to flowering or seed-set by tillage, herbicide application, and hand weeding. Records of inspections and roguing must be maintained.
- If seed of transgenic wheat is accidentally spilled or released, recoverable seed must be collected and destroyed immediately. If the incident is in a field location, as much of the seed as possible must be recovered, destroyed, and the site treated as a plot with monitoring for at least two crop years, and any volunteers treated with a killing herbicide prior to flowering. The Foundation Seedstocks Director, the Director of the NDAES, and the North Dakota Department of Agriculture will be notified of any field spills or accidental releases within one working day.
- Either USDA-APHIS inspects the plots for isolation distance compliance and monitor the crop destruction process, or the ND Department of Agriculture must be supplied with the information necessary to permit monitoring by NDDA.
- Data from field trials will be compiled, reviewed by NDAES scientists, and made part of the decision process toward potential cultivar release. Whenever data are protected by confidentiality agreement, terms of the agreement will be honored.
- Elsewhere than in the field, transgenic plants will be grown in bio-containment units. Units are greenhouse and/or laboratory facilities that are exclusively designated to work on transgenic crops.
- Until isolated facilities and equipment are available to the Cereal and Food Sciences Department (CFS) at NDSU, dust from milling transgenic wheat could be a source of contamination of milled non-transgenic wheat products. Current facilities cannot be cleaned sufficiently to preclude contaminations from subsequent processing. Until tolerances for transgenic levels in milled-wheat samples are established, milling of transgenic wheat will not occur in the same room, nor will the same equipment be used for milling non-transgenic wheat.
NDSU researchers will comply with all laws, rules, and regulations. NDSU policies do not supersede established rules. However, they may be more restrictive or precautionary. Failure to comply with rules and policy will bring sanctions in accordance with NDSU Policies up to, and including, dismissal. NDSU policy and procedures provide for protections consistent with its land grant mission and to protect public interests. Any inconsistencies with standing statutes or regulations must be brought to the attention of the Director of the NDAES for reconciliation.
Definitions
Non-regulated Transgenic crops: Transgenic crops that have been approved by the USDA, FDA and the EPA for nonrestricted production. Examples are soybean, canola, corn, cotton, sugar beet, rice and flax resistant to some herbicides; corn, cotton and potato having some insect resistance; squash, potato having resistance to a specific virus; and high oleic acid soybean.
Regulated Transgenic crops: Those crops having specific traits not yet approved for nonrestricted production because all the steps for regulation have not been completed or regulation has not been applied for. Regulations include field and greenhouse monitoring and isolation, destruction of research material residue and seed monitoring.
March 18, 2003, updated August 31, 2004
Questions
Questions or comments regarding this policy should be directed to ND Agricultural Experiment Station Director.
Policy Committee: Ken Grafton, Director, North Dakota Agricultural Experiment Station; Jim Venette, Associate Dean for Academic Programs, NDSU; Al Schneiter, Department Chair, NDSU Plant Sciences; Duane Hauck, Director, NDSU Extension Service; M. Dale Williams, Director, NDSU Foundation Seedstocks; Ken Bertsch, Seed Commissioner, North Dakota State Seed Department; Dave Nelson, North Dakota State Ag Department