US Regulatory Process For Genetically Modified Trees
Lara Vallely
Summer 2002
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US Regulatory Process For Genetically Modified Trees
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Overview
In 1986, the White House Office of Science and Technology Policy established the Coordinated Framework for the Regulation of Products of Biotechnology (Coordinated Framework). Through the Coordinated Framework the federal government expressed its commitment to the safe development of genetically modified organisms, and established regulatory authority over products of biotechnology for 3 federal agencies. 1
The foundation of US regulation established in the Coordinated Framework is the underlying assumption that the risks associated with products of biotechnology are no different than risks associated with conventional breeding. Specifically, regulation assumes that introducing a genetically modified organism into an ecosystem holds no more risk than introducing unmodified organisms or organisms modified by conventional breeding techniques. Essentially, the Coordinated Framework established regulation that looked at genetically modified products according to their characteristics and novel features, and not by their method of production. 2
Under the Coordinated Framework, the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) are responsible for evaluating the safety of genetically modified crops. Products are regulated according to their intended use, leaving some products regulated by more than one agency. The following chart displays the regulatory responsibility of each agency.
Chart1. Overview of U.S. regulatory agencies and their oversight jurisdiction.
Source: USDA Overview of Regulatory Oversight in biotechnology.
http://www.aphis.usda.gov/ppq/biotech/usregs.html
| Agency | Products Regulated | Regulated For |
| APHIS | Plant pests, plants, veterinary biologics | Safe to grow |
| EPA | Microbial/plant pesticides, new uses of existing pesticides, novel microorganisms | Safe for the environment |
| FDA | Food, feed, food additives, veterinary drugs, human drugs and medical devices | Safe to eat |
Trees genetically modified to enhance timber quality would regularly fall under the regulatory authority of two of these agencies, APHIS and EPA.
USDA�APHIS
APHIS has the large and encompassing responsibility to protect the U.S.�s animal and plant resources. To do this, APHIS has been given specific regulatory authority to �safeguard resources from exotic invasive pests and diseases,� and to monitor and manage existing agricultural pests and diseases in the U.S.3
APHIS�s regulatory authority over biotech products falls under the realm of plant pests.4 Any genetically modified organism is subject to APHIS regulatory authority to the extent it is or is suspected to become a plant pest. Commonly called regulated articles,5 these organisms must get approval from APHIS prior to introduction into the environment (�outside the constraints of physical containment�).6
APHIS�s regulatory authority over genetically modified organisms stems from the Plant Protection Act (PPA) and the Plant Quarantine Act (PQA). The PPA became law in June 2000 as part of the Agricultural Risk Protection Act, and gave APHIS the primary responsibility to determine whether or not a plant or plant product has the potential to become a plant pest. Accordingly, APHIS was given authority to prohibit or restrict the importation, exportation, and the interstate movement of plants, plant products, certain biological control organisms, noxious weeds, and plant pests.7
APHIS has 4 major regulatory procedures regarding genetically modified plants, including notification, permit applications, petition for deregulation, and an extension of a deregulated status. Notification or a permit application is required for the field-testing, importation, and interstate movement of regulated articles. A petition for deregulation and an extension of a deregulated status are required for commercialization.
Notification has become the most common means to field test regulated articles in the past few years. Instituted in 1993, it was established as a simplified and streamlined process to field-test, import, and move genetically modified plants. Originally intended for 6 major crops only (corn, tomato, cotton, soybean, potato, and tobacco), APHIS extended notification to cover most genetically modified plants in 1995. Currently all plants, unless they are pharmaceutical-producing or are considered noxious weeds, can be field-tested for 1 year via approval through APHIS�s streamlined notification process. 8
To introduce a genetically modified plant through the notification system, the plant species must meet the following 6 eligibility criteria: 1) the plant must not be on the federal noxious weed list9 or be considered a noxious weed in the area of introduction, 2) inserted DNA must be stably integrated, 3) function of the inserted DNA must be known and known not lead to plant disease, 4) inserted DNA must not produce an infectious entity, produce substances likely to be toxic to non-target species, or encode products intended for pharmaceutical use, 5) virus-derived sequences must be known noncoding regulatory sequences or unlikely to produce virus virulence and spread in plants, and 6) inserted sequence must not be derived from potential human or animal disease-causing agents.10
Additionally, articles introduced through notification must follow and meet 6 performance standards intended to contain the regulated article and prevent its offspring from persisting in the environment. To meet APHIS performance standards, regulated articles must: 1) be transported and stored in ways that minimize the escape of viable plant parts into the environment, 2) not be mixed with nonregulated plant material, 3) maintain plant and plant part identity, and be contained or devitalized after use, 4) have no pathogenic vector associated with the plant, 5) be field-tested and managed in a way that precludes persistence of the plant and its progeny (meaning it should not be able to reproduce on its own), and 6) must be managed to prevent persistence of the plant or its progeny. 11
To aid institutions in the notification process, APHIS has created an extensive User�s Guide12 that gives sample notification letters and suggestions of information to include. Although APHIS does not require notifications to contain extensive data, they do require all notifications to include a description of the regulated article (including identity of the plant, method of gene transfer, and full description of inserted sequences) field-testing information (geographic details, size, means of transport, and duration), and a signed statement certifying eligibility criteria and performance standards are met.13
Upon receiving a notification letter, APHIS will provide appropriate State regulatory official(s) with a copy of the notification within 5 days. APHIS will notify the applicant of acknowledgement or denial of their request within 10 days of receipt of an interstate movement letter or within 30 days of receipt of an importation or environmental release letter. If introduction by the notification letter is denied, the applicant may apply for a permit.14
Permit applications are required for articles that do not qualify for notification or were denied notification. As with notification, permit applicants are trying to obtain authorization to move, import, or field-test a regulated article. The permit application is more detailed than the notification letter, and its primary purpose is to provide enough information for APHIS to determine if the article will become a plant pest. Information regarding confinement issues is emphasized in the application.
All permit applications must include information on the regulated article, the donor organism, and the vector or vector agent. Date of importation, movement or release, port of importation or site release, and a description of the anticipated or actual expression of the altered genetic material and how that differs from the nonmodified parental organism must also be included.
Additionally, the following information is required in a permit application:
APHIS conducts an environmental assessment for the proposed introduction of the regulated article from the permit applications. If a �Finding of No Significant Impact (FONSI) is made, APHIS approves the permit application. If approved, applicants must allow APHIS and state inspectors access to their test trials and submit field trial results within 6 months of field-testing.17
APHIS�s third regulatory procedure, a Petition for Determination of Nonregulated Status, is the sole route for commercialization of a transgenic plant and the major route for commercialization of transgenic plant products. The petition requests APHIS to determine if a particular GM plant should be considered a regulated article, that is, if it should be considered a plant pest. If APHIS grants a petition, it is stating that the regulated article does not pose a significant risk to be or become a plant pest, and therefore does not fall under APHIS�s regulatory authority.
Deregulation petitions include detailed scientific data that APHIS reviews on a case-to-case basis. APHIS uses the information given to determine if the proposed regulated article meets the following criteria: 1) displays no plant pathogenic characteristics, 2) is not more likely to become a weed than its parent organism, 3) is not likely to increase the weediness of cultivated, feral, or wild-related plants, 4) does not damage processed agricultural commodities, and 5) is unlikely to cause unintended harm to other organisms.18 As with notification letters and permit applications, APHIS provides organizations with a sample petition and user�s guide for determination of nonregulatory status.19
APHIS recommends that each petition include the following:
One particular concern many scientists have about deregulation is that it is absolute. Once APHIS approves a petition to deregulate an article, the agency has no regulatory authority over the transgenic plant or its progeny. They can no longer exercise additional oversight on the plant and its descendants or require monitoring of them.21
APHIS�s 4th regulatory procedure is an extension of determination of nonregulated status. This extension proposes that a currently genetically modified regulated article is similar enough to a previously deregulated article that it does not pose a plant pest risk, and accordingly, should be deregulated itself. The extension request is a streamlined petition that focuses on the differences between the currently regulated article and its substantially similar deregulated counterpart. 22
APHIS also provides a user�s guide for extension requests. In it, APHIS outlines genetic modifications it believes are unlikely to pose new risks beyond those that were considered in the related organism�s deregulation process.23 All petitions should include information on the phenotypic expression of the genetic modifications and any expected differences in phenotype between the currently regulated article and its related deregulated article. Additionally, petitions should include data from at least one field trial.24
EPA
I. Intergeneric Microorganisms
The EPA has regulatory jurisdiction over 2 types of GMOs, both of which are applicable to trees. The first includes genetically modified microorganisms created from genetic material combined from different taxonomic genera. These microorganisms are created to be used commercially as biofertilizers, biosensors, waste treatment or pollutant degradation, or for commodity or specialty chemical production.25 This type of genetic modification (and regulation) applies to genetically modified trees designed for bioremediation. Regulatory authority was given to the EPA under section 5 of the Toxic Substances Control Act (TSCA). The TSCA Biotechnology Program of the Office of Pollution Prevention and Toxics is responsible for regulation.26
Microorganisms subject to regulation under TSCA section 5 are viewed as �new� microorganisms. The EPA believes because they are formed by combining genetic material from organisms classified in different taxonomic genera, i.e., intergeneric, these microorganisms have a higher potential for exhibiting a new trait or combinations of traits. The EPA chose to establish regulation at this level because these new traits were unlikely to occur naturally, and can be viewed as the result of substantial human intervention.27
The TSCA Biotechnology Program has two regulatory procedures regarding intergeneric microorganisms. An MCAN, Microbial Commercial Activity Notice, is required to manufacture, import, or process a living intergeneric microorganism for commercial purposes. MCANs must be filed at least 90 days prior to a microorganism�s commercial manufacture, import, or processing. Currently, the EPA has not developed an MCAN form, although they are considering doing so after they gain additional experience with intergeneric microorganisms.28
The EPA has established requirements though, of what an MCAN notification should include. The following is a brief outline of the required information.
Institutions wanting to conduct an individual field test for intergeneric microorganisms are required to complete a TSCA Experimental Release Application (TERA). The TERA is similar to the MCAN in content, but requires less information and time to complete. The application should be submitted 60 days prior to testing (MCAN requires a 90 day review). It should only be submitted by institutions interested in conducting field tests on their products�institutions wanting to commercially manufacture, import, or process their new microorganisms must submit an MCAN.
Below is a brief review of information required in a TERA application.32
In addition to intergeneric microorganisms, the EPA also has regulatory authority over plant-incorporated-protectants. These protectants, commonly called PIPs, are pesticidal substances produced and used by living plants. These substances can occur naturally in plants, or they can be introduced into plants via conventional breeding or genetic engineering. When introduced through genetic engineering, PIPs must go through a registration process with the EPA to ensure they meet federal safety requirements. Plants containing pesticidal substances introduced through conventional breeding are exempt from most regulatory requirements. 34
One common example of a PIP is Bacillus thuringensis (Bt) bacteria. Scientists add the Bt gene to a plant�s genetic material, and the plant then produces its own pesticidal substance. The protein and the genetic material, in this case the Bt gene, are under the regulatory authority of the EPA. Regulatory authority was given to the EPA over PIPs through 2 statutes: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA). 35
The EPA has regulatory authority over PIPs because they have the broader responsibility of ensuring the safety of biological and chemical pesticides. To meet this responsibility, the EPA regulates the distribution, sale, use, and testing of plants and microbes producing chemical substances. With authority granted by FIFRA, the EPA issues experimental use permits for field-testing and registrations for the commercialization of PIPs as a means to regulate their distribution, sale, use, and testing. Under the FFDCA, the EPA sets tolerance limits for pesticides used on and in food and feed or establishes exemption from the limit through an evaluation process. 36
PIPs go through the same registration process as required of conventional chemical pesticides. There are numerous application forms and notifications to complete before the EPA will allow commercialization. In short, detailed information about the ingredients, a summary of the physical and chemical properties of the pesticide, and its proposed labeling and packaging must be included.37 There is a separate, and shorter, application for experimental use only.38 Upon receipt, all applications for experimental use or registration are announced in the Federal Register. 39
Regulation for PIPs was first established with the 1986 Coordinated Framework. In 1994 the EPA published proposed regulations describing their policies for PIPs (then called plant-pesticides). In 2001, the EPA issued its final ruling of these regulations.40
Notes