- USDA APHIS Proposes Amendments to Regulations Regarding Genetically Engineered Organisms
- July 31, 2009
- Law Firm: Keller and Heckman LLP - Washington Office
I. Introduction and Background
On October 9, 2008, the United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA or APHIS) proposed amendments to 7 CFR 340, "Introduction of organisms and products altered or produced through genetic engineering which are plant pests or which there is reason to believe are plant pests." APHIS monitors field-testing, movement, importation, or release of genetically engineered (GE) products under the Plant Protection Act (PPA, 7 USC 7701-7772) and regulations found in 7 CFR 340.
The regulations in 7 CFR 340, administered by APHIS, govern the introduction (importation, interstate movement, or release into the environment) of certain genetically engineered (GE) organisms termed ``regulated articles.'' Currently, regulated articles are GE organisms which might pose a risk as a plant pest or a potential plant pest. As currently written, the scope of the regulations does not include noxious weeds.
The 2008 Farm Bill (The Food, Conservation, and Energy Act of 2008) contains provisions that still need to be incorporated into 7 CFR 340. Furthermore, since these regulations were first promulgated in 1987, and with the advancements in technology and the experience gained in over 20 years of oversight, it has become necessary to update the regulations. The adoption of GE crops by farmers worldwide has become increasingly widespread. The benefits associated with the use of some GE crops already in production include higher yields, lower pesticide costs, and overall savings in management time. There are also environmental benefits from reduced pesticide use. The high rate of GE crop adoption by farmers has been driven by an increase in consumption of product developed with the use of GE techniques.
On April 29-30, 2009, APHIS held a public meeting regarding its proposed amendments to 7 CFR 340. Stakeholders that were present included various members of industry, public interest groups, the Food and Drug Administration, and the Environmental Protection Agency.
II. The Current Regulatory Environment
Because of the magnitude and extent of the application of GE technologies to various products that may interact with plants, animals, and humans, the regulatory oversight of biotechnology is shared by three government agencies. Specifically, the 1986 Coordinated Framework for the Regulation of Biotechnology mandates that the regulation of GE products be shared by FDA, EPA, and USDA, with each agency having enforcement power to regulate certain aspects of biotechnology under respective statutes. Under the Federal Food, Drug, and Cosmetic Act (FFDCA) FDA regulates the safety of all food (other than meat, poultry and egg products), including food and feed developed from biotechnology. Under FFDCA § 301 (Prohibited Acts), the adulteration of food and the introduction of adulterated food into interstate commerce are prohibited. Under FFDCA § 402, foods are considered to be adulterated if they contain any poisonous or deleterious substance which may render the food injurious to health, or if they contain an unapproved food additive. FDA has authority to remove food that has been found to be unsafe from the market. In this respect, the effective regulation of biotechnology is imperative to ensuring that the food supply remains safe and unadulterated by GE products that can be injurious, or by those which may be learned to have unintended or undesired effects based on data generated or information learned since the time of environmental release.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides the EPA with regulatory authority over pesticides. Certain features of the FIFRA are applicable when considering the regulation of pesticidal substances produces by certain GE plants. Pesticides are defined as substances intended for preventing, destroying, repelling, or mitigating any pest such as an insect, rodent, fungus, or weed. FIFRA generally prohibits the distribution and sale of pesticides in the United States unless the pesticide is registered for a particular use or exempt from regulation. The registration process requires the submission of substantial data and supporting evidence that the pesticide "will perform its intended function without unreasonable adverse effects on the environment." Pesticide registration is not required when EPA issues an experimental use permit. A permit is issued only if the applicant needs the field tests to accumulate the data necessary to register the pesticide. General authority to promulgate regulations for the enforcement of FIFRA is assigned to the Administrator of EPA.
USDA APHIS regulates field-testing, movement, and importation of GE organisms under the PPA and regulations found in 7 CFR 340. Under the PPA, the USDA has the authority to regulate the movement, importation, or release of plant pests or potential plant pests. The Secretary of Agriculture has authority to restrict importation and interstate movement of plants, plant products, biological control organisms, noxious weeds, or other articles when necessary, to prevent the dissemination of plant pests or noxious weeds. This includes genetically engineered plants that may pose damage to crops, public health, or the environment. Under the current regulation, APHIS determines whether to authorize the field-testing of agricultural biotechnology products through either a permit or notification procedures. The decision to authorize the test is based on whether the item will pose a risk to the environment or agriculture. After several years of field testing, a petition may be submitted to USDA APHIS to deregulate the crop and allow commercialization of the product.
III. The Proposed Rule
The object of 7 CFR 340 is to ensure that the environmental release, importation, or interstate movement of GE organisms does not pose a risk of introducing or disseminating plant pests or noxious weeds. Because the regulations in 7 CFR 340 were first promulgated by APHIS in 1987, and were based on the authority of the Federal Plant Pest Act of 1957 (FPPA, Pub. L. 85-36) and the Plant Quarantine Act of 1912 (PQA), and there are additional statutory authorities in the PPA that were not in these Acts, it is desirable to consider revisions that would better align the regulations with the Plant Protection Act of 2000. APHIS has also gained biotech regulatory experience that should be incorporated into the regulations to improve the processes. Many technological advances have occurred, and these advances and potential future advances should be considered in developing the new regulations. In addition, APHIS is proposing changes to the regulations to reflect provisions of the 2008 Farm Bill recently enacted. The proposed changes are intended to improve the regulatory process by providing greater transparency, flexibility, and efficiency.
B. Description and Estimate of Compliance Requirement
The proposed rule, broader in scope than the current 7 CFR 340, would require additional and modified information collections regarding GE products through recordkeeping, reporting, and notifications to APHIS when certain events occur.
1. Broader Scope
Although APHIS's current program under 7 CFR 340 has been effective in ensuring the safe environmental release, interstate movement, and importation of GE organisms, technological advances have led to the possibility of developing GE organisms that do not fit within the definition of "plant pest," but may cause environmental or other types of physical harm or damage covered by the definition of "noxious weed" in the PPA. "Noxious weed" encompasses plants that pose risks akin to plant pests, because it includes "any plant or plant product" that can "injure or cause damage to crops *** other interests of agriculture *** or the environment," but also includes plants that can pose harm to non-plant organisms such as humans. Therefore, APHIS proposes to align the regulations with both the plant pest and noxious weed authorities of the PPA. Specifically, Section 340.0 would make clear that decisions regarding which organisms are regulated remain science-based and take both plant pest and noxious weed risks into account.
The proposed scope of the regulations states that genetically engineered organisms whose importation, interstate movement, or release into the environment would be subject to the regulations are:
Genetically engineered plants if:
(i) the unmodified parent plant from which the GE plant was derived is a plant pest or noxious weed; or (ii) the trait introduced by genetic engineering could increase the potential for the GE plant to be a plant pest or noxious weed; or (iii) the risk that the GE plant poses as a plant pest or noxious weed is unknown; or (iv) the Administrator determines that the GE plant poses a plant pest or noxious weed risk.
Genetically engineered non-plant, non-vertebrate organisms if:
(i) the recipient organism can directly or indirectly injure, cause damage to, or cause disease in plants or plant products; or (ii) the GE organism has been engineered in such a way that it may increase the potential for it to be a plant pest; or (iii) the risk that the GE organism poses as a plant pest is unknown; or (iv) the Administrator determines that the GE organism poses a plant pest risk.
Under the current regulations, there is no explicit statement of the relative responsibilities of the Administrator and regulated parties in determining whether an organism met the definition for regulated article and therefore would be subject to the regulations. Under the proposed regulations, the responsible person for a GE organism could correctly apply the criteria in Sec. 340.0 to determine whether the GE organism is subject to the regulations. Alternatively, the Administrator could determine any GE organism to be regulated after determining that the GE plant poses a plant pest or noxious weed risk. In many cases, the determination of the regulatory status of a GE organism will be easily determinable. In others, whether a GE organism is subject to the regulations will not be readily apparent. In these instances, consultation with APHIS regarding the scope of Section 340.0 with respective to the GE organism will be available. When considering risks associated with a GE plant, APHIS will continue to consider whether it can harm plants, as well as whether it can cause the other types of physical harm or damage described in the definition for noxious weed.
GE microorganisms that are regulated by the EPA as biological control organisms under FIFRA are excluded from the scope of the proposed amendments to 7 CFR 340. Also proposed for exclusion are GE microorganisms where the recipient microorganism is not a plant pest and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions. GE vertebrate animals do not fall within the scope of the proposed regulations; however, GE biological control organisms (BCOs) can fall within the scope of the proposed regulations if they pose a threat as a plant pest or noxious weed and are not already regulated by EPA under FIFRA.
Both the current and proposed regulations do not govern intrastate movements between contained facilities such as laboratories, nor do they govern such activities as creating GE organisms in a contained laboratory. In addition, APHIS proposes to clarify the regulated status of nonliving plant products by including GE seedlings, seeds, tubers, cuttings, bulbs, spores, etc. as regulated products because there is a possibility of reproduction, establishment, and spread if these were deliberately or accidentally released into the environment without authorization.
2. Notifications Eliminated; All Authorizations Require Permits
According to the notification procedure added in 1993, APHIS administratively streamlined the procedure for certain GE plants that it determined met the eligibility criteria described in the regulation. Its reviews of notifications have been not only to verify the eligibility criteria, but also to evaluate whether the proposed importation interstate movement or environmental release can be done in a manner that meets the performance standards described in the regulation. The notification procedure is predicated upon applicants agreeing to meet the pertinent performance standards. APHIS maintains that under this regime, it is difficult for its inspectors to determine if a notification holder is in compliance and can also make enforcement more difficult. Thus, it wishes to eliminate the notification procedure. Under the proposed regulations where all authorizations will be done under a permitting procedure, the permit conditions will provide more specific information about what procedures the permit holder must follow in order to be in compliance.
APHIS also proposes to reorganize the regulations to improve the clarity of the permit application and evaluation procedures. The nature of these changes is administrative rather than substantive, with the intent to enhance the transparency of the regulations to the public. More procedural steps have been proposed, including explicit procedures for amendment, transfer of responsibility, and revocation of permits in order to establish clear regulatory procedures that can increase efficiency yet maintain adequate safety.
Most significantly, along with the elimination of notifications, APHIS would continue to issue three types of permits – interstate movement, importation, and environmental release. Environmental release permits would be differentiated into broad risk-related categories by the Administrator. The proposed sorting system for environmental release permits includes five categories: four for releases of GE plants (Categories A-D) and one for releases of all other GE organisms (Category E). Releases of Category E organisms would be placed into a single category and reviewed on a case-by-case basis. APHIS will consider two primary factors to define its sorting system for the environmental release permits: 1) the ability of the unmodified recipient plant species to persist in the wild; and 2) potential of the engineered trait to cause harm, injury, or damage, as described in the definitions of plant pest and noxious weed. Secondary factors, which in some instances may change the initial categorization, include: how the recipient plant is commonly used; the impact of the engineered trait on the fitness of the GE plant; and the degree of uncertainty associated with the trait and its possible impact. The sorting system will organize both the plant species and the engineered trait in order of increasing potential risk or hazard, respectively, from low to severe.
As to the substance to be included in applications for permits, in addition to that which is already required, APHIS proposes requiring more detail and more description of the applicant's plans and methods to prevent unauthorized releases, and to respond to unauthorized releases if they occur. This information will be used by APHIS to specify the conditions for each permitted GE substance. Conditions are specific practices or requirements that an applicant must follow upon issuance of a permit. In cases where the permit is for environmental release, and would be in permit categories of high to severe risk to the species and harm presented by the GE trait, a greater level of detail would be required for almost all aspects of the activity, including the recipient organism, the inserted gene(s), site location and management practices, and training and communication among the permit holder and agents involved in the activity covered under the permit. This information would also address the capability of the organism to persist or spread in the environment, or include details about how the engineered traits might be harmful. The Administrator will assign the permit conditions in a manner that is commensurate with the risk of the individual proposed movement or release.
Finally, in an effort to better allocate resources, APHIS is also proposing to eliminate the issuance of courtesy permits, which have been issued since 1987 to facilitate the movement of organisms which are outside the scope of 7 CFR 340 and whose movement might otherwise be hindered because of their similarity to organisms subject to these regulations. APHIS will be available for consultation to those who formerly used courtesy permits to discuss how to facilitate the movement of non-regulated organisms.
3. Conditional Exemptions
Exceptions to the permit requirement are referred to as "exemptions" in 7 CFR 340. Exemptions included in the proposed rule would yield time savings because the permit application process in those instances would be eliminated. APHIS proposes to retain the existing conditional exemptions from the requirement for interstate movement (including for certain GE strains of the microorganisms Escherichia coli, Saccharomyces cerevisiae, and Arabidopsis thaliana), and also proposes a new regulatory procedure that would help it to approve new conditional exemptions more efficiently than using the procedure of notice and comment rulemaking for each individual exemption.
The existing essential conditions for the conditional exemptions address the following: 1) species of the GE organism; 2) the types of genetic modifications that are allowed or prohibited for the GE organism; and 3) the manner in which the GE organism is shipped interstate. APHIS proposes to update the text of the conditional exemption to place the shipping requirements with the other conditions associated with the exemption, instead of the current regulatory organization that has the shipping requirements in a separate section of the regulation. The new procedure also incorporates transparent steps including scientific review, public input, and adaptability when APHIS establishes the conditions relevant to the specific conditional exemption. The Administrator's decision to approve an exemption would be based upon a determination that the exemption from the requirement for a permit, when conducted with the associated conditions, is unlikely to result in the introduction or dissemination of a plant pest or noxious weed. The information needed for a petition for conditional exemption would depend on the nature of the exemption requested and the proposed conditions for exemption.
In evaluating whether to approve a new conditional exemption, APHIS would carefully consider issues related to enforceability of the conditional exemption when proposing to approve a conditional exemption. Unlike permit conditions, which are binding on the specific responsible person, the conditions associated with the exemption would apply to anyone who conducts the activity under the conditional exemption. APHIS also proposes that the Administrator may revoke any exemption after it is approved if subsequent information is received that demonstrates that circumstances have changed such that the exemption is likely to result in the introduction or dissemination of a plant pest of noxious weed. While a revocation could not be appealed, a new petition for conditional exemption may be filed.
4. Petitions for Nonregulated Status
The current regulations include a procedure by which anyone may petition APHIS to grant "nonregulated status" to a GE organism, which means it would no longer be subject to the regulations in part 340. Currently, the basic standard for a determination of nonregulated status has been related to plant pest risk. Consistent with the proposed broadening in scope of part 340, APHIS proposes to also consider whether the GE organism is unlikely to be a noxious weed. Due to public misunderstanding and confusion, APHIS also proposes to eliminate the "extension procedure," whereby it currently extends its determination of nonregulated status to a GE organism based on the similarity of it to an antecedent GE organism that has already been granted nonregulated status. Finally, based on the history of safe use in the U.S. and in other countries, APHIS proposes that all previous determinations of nonregulated status made since the early 1990s under the part 340 regulations be approved for nonregulated status.
Both the current and proposed rules require APHIS to be notified if an unauthorized release occurs or if during release the GE organism is found to have characteristics substantially different from those anticipated by the permit. On March 29, 2007, APHIS published a Federal Register notice titled "Policy on Responding to the Low-Level Presence of Regulated Genetically Engineered Plant Materials." This notice described how APHIS responds when low levels of regulated GE plant materials occur in commercial seeds or grain that may be used for food or feed. This issue was also addressed in DEIS, in which APHIS proposes to establish criteria under which the occurrence of a low level presence (LLP) of GE plant materials in seeds or grain may not be cause for agency remedial action. Specifically, criteria would be listed as well as descriptions of possible enforcement actions in the regulations to improve transparency regarding how APHIS would respond to LLP in most instances. APHIS would not predetermine a specific level that is considered non-actionable, and would treat each instance on an case-by-case basis using criteria that would support a conclusion that LLP is unlikely to result in the introduction or dissemination of a plant pest or noxious weed. Because the criteria will be safety-based, they will be used for incidents of LLP originating from domestic field testing, as well as LLP that are detected in import shipments that may contain organisms subject to regulation.
APHIS proposes permission to audit the records and conduct inspections related to the regulated activities. The proposed rule is more specific about the types of records that must be kept for importations, interstate movements, and environmental releases, where the current regulations left more of these details to be specified only in permit conditions. In terms of record retention requirements, the proposed rule spells out a 2-year retention for records indicating that a GE organism imported or moved interstate reached its intended destination, and a 5-year retention for all other required records. By providing more specific information on what records are required, the proposed rule should alleviate some current burden that may result from persons keeping unnecessary records. APHIS has also identified gaps in information currently included in records, and proposes that additional information pertaining to field trial operations over time be added to recordkeeping procedures, including the procedures, equipment and safeguards APHIS approved were actually employed, the specific dates on which trials were carried out, the identities of staff members or contractors responsible for performing which duties, the responsibilities of different organizations when several entities have been involved in a field trial, and the written contracts and agreements between entities, researchers, developers, or any other parties that are sharing performance of tasks required by the permit for a field trial.
In addition, APHIS has established the Biotechnology Quality Management System (BQMS), which is a voluntary compliance assistance unit within USDA APHIS. BQMS would facilitate the regulatory efforts of USDA APHIS by conducting outreach activities and providing compliance assistance to the regulated community. This would lessen any burden of the proposed rule to the regulated community. In addition to the information provided in the regulation itself, guidance documents would be provided by USDA APHIS to assist in the preparation and submission of applications.
C. Duplication, Overlap, and Conflict with Existing Rules and Regulations
APHIS has identified areas where the proposed rule will need to be closely coordinated with other Federal rules and statutory authorities. Coordination has been an important aspect of the daily implementation of the current regulation, and APHIS foresees additional areas for coordination under the proposed rule. In particular, APHIS will coordinate with FDA and EPA. As examples of areas that need coordination, some of the plant-incorporated protectants regulated by EPA are also subject to APHIS requirements under the PPA. Also, FDA is the primary U.S. agency responsible for ensuring the safety of commercial food and food additives, and FDA authority extends to any nonpesticidal substance that may be introduced into a new GE plant and that is expected to become a component of food. The proposed regulations would clarify the regulatory scope and procedures used by APHIS relative to these other agencies and improve the coordination process.
IV. Public Meeting Held by APHIS on April 29-30, 2009
Many who attended the public meeting held by APHIS regarding the proposed amendments to 7 CFR 340 voiced opinions, concerns and criticisms. Given the efficiencies of the current regulatory scheme and the 20-year history of the safety of GE organisms, industry representatives are cautious of USDA's potential to overregulate this class of products. Throughout the meeting, industry representatives continually underscored that they should continue to have freedom to conduct research to develop new technologies, especially those which may be applied to consumer food and pharmaceutical applications. Particularly given the past year's incidents regarding the safety of the nation's food supply, consumer representatives emphasized the importance of APHIS's proposals that would reinforce the safety of GE organisms, as well of interagency coordination so as to ensure that any concerns regarding the organism and its applications have been thoroughly vetted. While the proposal to broaden the scope of the regulations was generally accepted, many raised the concern that the preamble to the regulations be written more clearly so as to stress that only APHIS can determine the status of a GE organism; that is, self-determination as to the application of 7 CFR 340 should not be tolerated. Finally, although the definition of "science-based" was debated, all stakeholders present at the meeting agreed that regardless of the amendments to 7 CFR 340, they be applied in a science-based manner when determining the status of a GE organism and assessing its risk.
Links to the proposed rule, written comments thus far submitted, and transcripts of the public meeting are located at: http://www.aphis.usda.gov/.