USDA's Role in Federal Regulation of Biotechnology
January 10, 2006
Biotechnology
Biotechnology offers agriculture many possibilities — from developing crops that require less pesticides and fertilizers, to plants that provide needed pharmaceuticals. But, as with any emerging technology, unknown risks may also accompany the benefits, and genetically-engineered crops and other organisms are no exception.
The federal government has taken steps to ensure that products of biotechnology are developed and used safely, allowing the biotech industry and public institutions to continue to develop products that are beneficial to farmers and consumers, while protecting the public and the environment from unwanted risks.
Coordinated Approach
When industry first began to use biotechnology, the federal government determined it more productive to use existing authority from Congress to address the technology, rather than seek new legislation focusing on biotechnology. Seeking a coordinated approach to the regulation of genetically-engineered, or GE, organisms, the federal government established a formal policy called the “Coordinated Framework for Regulation of Biotechnology” in 1986.[1]
The Coordinated Framework doesn’t create any new statutes because it was determined that previously enacted laws could address GE products. These statutes — the Plant Protection Act (PPA)[2], Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)[3], Toxic Substances Control Act (TSCA)[4], and Federal Food, Drug and Cosmetic Act (FFDCA)[5] — have been interpreted to enable the assessment and management of the potential health and environmental risks of GE organisms.
The Framework designates appropriate agencies for review of GE products and sets recommendations as to coordination of review between agencies when authority overlaps. The agencies responsible for enforcement of the Framework are the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Each agency evaluates a different set of risks, based on the intended uses, composition, and stage of development that the product is in, and promulgates regulations, policies and guidance that implement these laws as GE products are developed. Depending on its characteristics, a product may be subject to review by one or more of these agencies.
U.S. Department of Agriculture
USDA's role regarding biotechnology is managed by the Animal and Plant Health Inspection Service (APHIS). APHIS is responsible for protecting the health of plants and animals in U.S. agriculture and the environment, administering the Animal Welfare Act, and carrying out wildlife damage management activities. Products of biotechnology are regulated by APHIS’ Biotechnology Regulatory Services.
Biotechnology Regulatory Services
In 2002, USDA created a new unit within APHIS to focus on biotechnology regulation. Biotechnology Regulatory Services, or BRS, regulates the importation, interstate movement and field testing of genetically-engineered organisms.[6] BRS coordinates USDA's domestic regulation and policy regarding GE organisms and coordinates with EPA and FDA on their regulatory efforts. BRS also works with foreign governments and in international forums such as the International Plant Protection Convention (IPPC) and the Organization for Economic Cooperation and Development (OECD) to promote adoption of harmonized, science-based regulations and standards. BRS also communicates USDA's approach to biotechnology regulation through press releases, federal register notices, workshops, outreach materials, the APHIS website, and other means. It seeks to protect America’s agricultural and natural resources by ensuring the safe development of GE organisms using a science-based regulatory framework.[7]
BRS regulates the field testing of GE organisms to ensure that new plant varieties pose no threat to production agriculture or to the environment during cultivation. Since 1986, more than 10,000 field tests have been safely conducted under APHIS' oversight.
Notifications and Permits
APHIS requires, depending on the plant, a notification or a permit for the importation, interstate movement or field testing of plants modified through biotechnology. USDA scientists review plans submitted by applicants seeking to import, transport or field test GE organisms, and they evaluate the procedures for any potential risks. BRS also contacts the affected states to notify them of any field tests that may take place in that state.[8]
Notification Process
As APHIS gained more knowledge and experience with the field testing of certain crops, it developed an expedited permit review process called the notification process. This is a streamlined process allowed for low-risk crops (often pest resistant or herbicide tolerant GE plants) and requires less paperwork than the permit process, although the applicant must comply with established APHIS performance standards for movement, planting, growing, harvesting and isolation. BRS requires that applicants provide detailed information about the plant, such as the sources and identity of any genes introduced, the method of genetic engineering, and the size, duration, and location of the field test. If the plant does not meet the criteria for notification, or if the engineered organism is not a plant, the applicant must follow the full permitting process. Most GE plants are field tested under the notification process.
Permitting Process
A permit is required for field tests of non-plant products or plants that could pose elevated risk, such as those that produce pharmaceutical or industrial compounds. The permit process is also used for insects and microorganisms.[9] More detail is required under the permit process than for notifications, and may include how the field test will be performed, a detailed description of how the organism will be moved, and/or procedures to ensure the organism does not escape. Depending on the field test, BRS may impose additional measures and permit conditions to ensure safety and confinement.
Applicants must provide complete information on the new organism, including the new genes and new gene products, the nature of the organism, its origin, the experimental design and procedures for field production and isolation, and the precautions taken to prevent the release of the organism. During the permit process, APHIS reviews the experimental design for the field test to ensure that it will not pose harm to the surrounding environment.
One trait that APHIS considers is the plant’s potential for outcrossing, or the unintentional breeding of a domestic crop with a related species. If there is a high risk for a new plant variety to outcross with a weedy relative, APHIS may not authorize a field test or may place greater restrictions on the field test.
Under the permit process, field test sites are monitored after the plant has been harvested, and any new seedlings or unwanted plants that sprout following the harvest are destroyed.
Additionally, if the GE organism is moved interstate or imported into the U.S., the developers must apply for a permit as well, stating the nature of the organism, its destination and means of movement, and how it will be contained during shipment.
Pharmaceutical and Industrial Crops
A pharmaceutical or industrial crop is a plant that has been genetically engineered to produce a medical or industrial compound. Uses of these compounds include human or veterinary drugs, industrial or research chemicals and enzymes, and other beneficial products. Since 1991, more than 90 permits for pharmaceutical and industrial field tests have been issued.
In 2003, USDA increased regulatory requirements for plants that produce pharmaceutical and industrial chemicals by requiring all applicants to receive a permit, instead of using the streamlined notification process. APHIS reviews all applications on a case-by-case basis, following rigorous standards.
APHIS' BRS reviews all field tests of pharmaceutical crops to ensure that there is no harm to agriculture or the environment. BRS evaluates the potential risks of the field tests or movement of the crops, and studies the measures to confine the field trial and the potential environmental effects. Only if all conditions are met will BRS issue a permit.[10]
APHIS imposes more stringent confinement measures for these crops than for field tests of conventional GE crops, such as increased isolation distances and fallow zones, and also imposes other conditions on the permit such as required use of dedicated equipment, mandatory training, and increased inspections. During the growing season, measures must be taken to achieve reproductive isolation from any sexually compatible plants to prevent cross-pollination with cultivated or wild plants that are not part of the field test. Environmental effects considered include impacts on threatened and endangered species, toxicity of the GE plant to non-target organisms, and the likelihood of such organisms to be exposed. In cases involving new risks, such as a new species, BRS prepares an environmental assessment accompanied by a public comment period.
Compliance and Enforcement
BRS created a new compliance and enforcement unit[11] in 2003. The unit's goal is to strengthen and improve compliance by ensuring developers of GE organisms comply with permit conditions and Federal regulations. Compliance is encouraged through education and outreach to the developers, inspection of field sites, and investigations and audits.[12] Also, by working closely with the State Departments of Agriculture and other federal agencies (including FDA and EPA), BRS can enhance its compliance oversight.
Inspectors perform targeted, risk-based inspections of field tests grown under notification. Permitted fields are inspected at least once, and pharmaceutical and industrial field tests are inspected up to seven times before, during and after the field trial to verify that developers are carefully following the conditions specified in the permit. An inspection will warrant one of three responses, depending on whether the developer is following regulatory or permit conditions—either 1) no deviations from conditions set forth by BRS, 2) Guidance (minor deviations from conditions) or 3) Warning (serious deviations from the conditions).
If a developer fails to follow the permit conditions laid out by APHIS or the BRS regulations[13], BRS will demand immediate corrective actions. Often, it is the developers themselves that report to BRS an infraction of the compliance conditions. If necessary, APHIS’ Investigative and Enforcement Services (IES) may investigate the infractions and USDA may issue civil penalties.[14]
Role of States
Before approving a notification or permit field test in any state, APHIS provides state officials with information about the planned test for review. If the state has concerns, BRS works to address those concerns, altering test requirements or adding additional permit conditions that the state feels is necessary. APHIS has not approved any tests over objection of state officials.
States are also consulted before BRS issues a permit for the importation or interstate movement of regulated GE organisms. BRS also coordinates with the states and provides information regarding compliance issues when appropriate.
Deregulation
GE crops extensively field-tested can be deregulated, if the developer can demonstrate that the product does not pose a plant pest risk. BRS performs an environmental assessment to further assure that the crop does not adversely affect the environment and, upon conclusion of this review, BRS may conclude that the organism poses no significant risk and reach a determination of a Finding of No Significant Impact (FONSI). Once the FONSI is prepared and a public comment period is over, APHIS may grant a petition for non-regulated status allowing the product to be planted or moved without permits or USDA regulatory oversight. In addition, the applicant must complete all applicable reviews by other regulatory agencies.
Confidential Business Information
Permit applications submitted by developers asking to move, field test, or deregulate a GE organism may contain trade secrets or other confidential business information (CBI). Developers may not want the CBI information in the public domain and must submit two applications—one with the CBI information included and a second without the CBI information.
For a company to claim confidentiality, it must submit a written justification for each claim. Trade secrets, financial data, research methodology, and information relating to the production process, such as formulas, processes, and quality control tests and data may be claimed as CBI, as long as they are “(1) commercially valuable, (2) used in the applicant's business, and (3) maintained in secrecy.”[15] If the product meets these criteria, the information must be kept confidential by APHIS.
Draft Environmental Impact Statement
The field of biotechnology is evolving very rapidly. In order to ensure appropriate regulation of the next generation of biotech products, BRS is in the process of revising the regulations that govern genetically engineered organisms. The first step will be the publication of a draft Environmental Impact Statement (EIS) to consider the implications of various regulatory approaches. The EIS process allows BRS to hear public input on its regulations from interested stakeholders, the scientific community, and the public in general.[16]
By revising its regulations, BRS is undertaking a programmatic review of existing regulations addressing biotechnology to better assess the areas needing clarifying, altering or strengthening. The EIS process gives BRS a chance to frame its response, based on comments from the public, to focus on areas within regulations in greatest need of revision. It also allows BRS to evaluate the environmental issues associated with potential revisions to existing regulations and to look into developing new criteria to review applications to conduct GE crop field tests based on risk, familiarity, and intended use (i.e. for pharmaceutical or industrial purposes).
NOTES:
1. Executive Office of the President, Office of Science and Technology Policy. 51 FR 23302, June 26, 1986.
2. Plant Protection Act; Title IV of the Agriculture Protection Act.
3. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); 7 USC Chapter 6)
4. Toxic Substances Control Act (TSCA); 15 USC Chapter 53)
5. Federal Food, Drug, and Cosmetic Act (FFDCA); 21 USC Chapter 9)
6. More precisely, organisms that have been altered by or produced through genetic-engineering and that could be plant pests.
7. For more information, visit http://www.aphis.usda.gov/brs/
8. APHIS Factsheet; "Biotechnology, Federal Regulation, and the U.S. Department of Agriculture," August 2005.
9. APHIS Factsheet, "APHIS Biotechnology: Permitting Progress into Tomorrow," October 2005.
10. Biotechnology Regulatory Services, "Permitting Genetically Engineered Plants That Produce Pharmaceutical Compounds;" http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_brspharmaceutical.html, July 2005.
11. The unit is known as the "Compliance and Inspection Branch (CIB)" within APHIS.
12. APHIS Biotechnology Regulatory Services, "APHIS Biotechnology: Compliance and Inspections," Factsheet, November 2005.
13. Such actions are termed "non-compliance incidents" by APHIS.
4. APHIS Biotechnology Regulatory Services, "APHIS Biotechnology: Compliance and Inspections," Factsheet, November 2005.
15. APHIS web page: “Instructions for Submitting Confidential Business Information (CBI) and CBI-Deleted Information,” www.aphis.usda.gov/brs/cbiinfo.html.
16. To view the EIS process, visit http://www.aphis.usda.gov/brs/eis/index.html. |
