Agricultural Biotechnology Regulations
1 February 2009 Microbial Pesticides
Microbial pesticides are regulated by EPA. USDA/APHIS (Animal and Plant Health Inspection Service) may also regulate microbial pesticides depending on their origin and potential to be a pest.
APHIS regulates the importation and may regulate the interstate movement of a microbial pesticide. Environmental release may be regulated by the Office of Pesticide Programs of EPA and APHIS. Pesticide use is regulated by both EPA and the states. Any pesticide, including microbial pest control agents, must also be registered with the states before it can be marketed in that state.
Permit Applications
APHIS has the authority to regulate certain microorganisms, including microbial pesticides, under the authority of the Federal Plant Pest Act (FPPA), and the Plant Quarantine Act (PQA). Permits for any microorganisms that are nonindigenous or genetically engineered, or that may be a potential pest to U.S. agriculture, are required for importation, interstate movement, and/or release into the environment.
In April 1997, the USDA’s Animal and Plant Health Inspection Service issued a final rule to streamline procedures governing the testing of genetically engineered plants and their release into the environment. In addition, the rule expedites review for certain determinations of nonregulated status.
Under both the previous and new rules, companies that want to field-test genetically modified plants must first obtain approval from the USDA. The new rule’s streamlined procedures, however, make it possible for most companies to conduct field testing under a notification procedure rather than under a formal permitting process, which takes longer and requires more data to be submitted. The permit procedure still will be required for certain circumstances:
- If the gene used in the test is derived from a human or animal pathogen.
- If a company cannot certify to the USDA that no tested plant or plant progeny will remain in the environment once the field test is complete.
With regard to grants of nonregulated status for new genetically engineered plants, the new rule provides the agency with additional flexibility in making such determinations. Under the new rule, the agency can now decide to extend an existing determination of nonregulated status to new plants “closely related” to the existing nonregulated plant. (Nonregulated status is conferred on a plant after it is found that there is no plant pest risk and that it is safe to grow as any other variety of the same plant.) These new regulations went in effect in May 1997 (7 CFR 340).
Small-Scale Environmental Release
Experimental Use Permit regulations (40 CFR Part 172) were amended in September 1994, to require notification of EPA prior to initiation of small-scale field testing of certain microbial pest control agents (MPCA) in the environment. The amended regulations generally do not require notification for small-scale field testing of nonindigenous MPCAs. Prior policy required that EPA be notified prior to small-scale field testing of both genetically altered and nonindigenous MPCAs.
The key points of the final rule are as follows
- EPA must be notified before initiation of small-scale testing of MPCAs that have been deliberately modified to enhance their pesticidal properties.
- Notification is not required for rearrangement(s) or deletion(s) of genetic material of an MPCA that may occur naturally.
- Notification is required only for nonindigenous MPCAs that have not been reviewed by APHIS.
- Notification is not required for MPCAs tested in a facility with adequate containment and inactivation control.
- One may petition to request the exemption of specific MPCAs or categories of MPCAs from the small-scale field testing notification requirement.
Experimental Use Permits And Registration
The Experimental Use Permit and registration process for a microbial pesticide is comparable to that of a conventional chemical pesticide. The EPA Pesticide Assessment Guidelines — Subdivision M, detail the general data requirements necessary to obtain an Experimental Use Permit and a registration for a bio-pesticide. The supporting data and the time required to obtain an Experimental Use Permit or to register a microbial pesticide are generally significantly less than the data and time required to register a conventional chemical pesticide.
Transgenic Plants And Plant Pesticides
USDA has issued regulations regarding importation, interstate movement, and/or release into the environment of transgenic plants. EPA and FDA have each issued “Statement of Policies” regarding regulation of transgenic plants. Although the EPA “Statement of Policy” was issued as a proposed policy, EPA is currently using the policy to register pesticide-containing transgenic plants.
USDA/APHIS
Permits must be obtained from APHIS/Biotechnology and Environmental Protection (BEP) and from each state that will be the destination of the importation and/or interstate movement or where an environmental release is planned. The permit must be obtained prior to the importation, movement, and/or release. BEP has published a very helpful document titled “User’s Guide for Introducing Genetically Engineered Plants and Microorganisms.” Further, APHIS has an excellent and very informative website at http://www.aphis.usda.gov.
An organization may petition APHIS to have an organism exempted from the regulations. APHIS may make a determination that the organism poses no plant pest risk. They have deregulated numerous transgenic plants from the requirement of permitting.
BEP must prepare an environmental impact statement for each environmental release (small-scale field trial). The environmental impact statements and the deregulation documents contain significant helpful information and are available from BEP.
In May 1997, EPA finalized regulations enabling APHIS to extend an existing determination of nonregulated status to additional organisms that resemble the organism for which the determination was initially made and extend the notification system to enable field testing under performance standards of most crop species.
APHIS has also announced its intent to develop guidelines on various topics to provide information relevant to its regulations to developers of new varieties and other interested persons. The first of these allows applicants to extend an existing determination of nonregulatory status.
FDA
FDA is responsible for food safety, except for meat and poultry. It is responsible for plants altered to contain substances intended to:
- Enhance the plant’s tolerance to chemical herbicides.
- Alter the nutritional composition of the food.
- Alter the flavor or texture of the food.
Producers of new foods have an obligation to ensure that the foods they offer are safe and in compliance with applicable legal requirements [primarily Section 402(a)(1)] of the Federal Food, Drug and Cosmetic Act. A producer may informally consult with FDA prior to marketing new foods to ensure that the safety and regulatory status of a new food are properly resolved. This action is not legally required. If a producer begins to market a new food based on its independent determination that the new substance is acceptable, and FDA subsequently concludes that it is not acceptable, FDA may take enforcement action.
A new food must be labeled accordingly if it differs from its traditional counterpart. A coalition of scientists, consumer groups, and religious leaders filed a lawsuit against the FDA in May 1998 to obtain mandatory testing and labeling of genetically engineered food. A decision on this case is pending.
International Harmonization of Regulatory Approaches
The United States has begun to internationally ship agricultural products derived from biotechnology. Due to differences between U.S. biotechnology regulations and many international regulations governing products derived from biotechnology, significant resistance to the importation of biotechnology (both seeds derived from biotechnology and foods which may include ingredients derived from biotechnology) has been raised. Further, numerous regulations for labeling of foods derived from biotechnology have either been adopted or are under consideration internationally.
In an effort to prevent trade barriers to U.S. biotechnology export, the U.S. government and industry are currently engaged on several fronts to bring about international regulatory harmonization with the European Union, OECD Environment and Agricultural Directorates, Conference of Parties to the Convention on Biological Diversity, and numerous other country-to-country negotiations.
EPA
EPA has indicated that it will focus its regulatory attention on the plant pesticide and not on the plant per se. A plant pesticide is defined as “a pesticidal substance that is produced in a living plant and the genetic material necessary for the production of the substance, where the substance is intended for use in the living plant.”
The EPA regulates pesticides and sets tolerances for residues of pesticides in food and feed. The agency is responsible for plants altered to contain substances intended to:
- Kill insects.
- Protect plants from viral, fungal, and bacterial infection.
- Act as plant or insect regulators.
EPA also regulates herbicide-resistant crops by regulating the herbicide for which the resistance is expressed.
EPA will generally exempt from regulation the following:
- Certain plant-pesticides commonly found in food.
- Coat proteins from plant viruses.
- Nucleic acids plant pesticides contained in transgenic plants.
The requirements for testing of transgenic plants containing plant pesticides are as follows:
1. Food or Feed Use
a. A temporary tolerance or exemption from the requirement of tolerance would be required unless an exemption from the requirement of tolerance already exists for the plant pesticide, or if there is adequate containment of the test site and the crop is destroyed.
b. Experimental Use Permit.
2. Non-food or Feed Use
a. A temporary tolerance or an exemption from the requirement of tolerance would not be required.
b. Experimental Use Permit — Not required if:
i) Plant subject to Plant Pest Act.
ii) Test area less than 10 acres per test or cumulative less than 50 acres of tests.
The requirements for sale or distribution of a transgenic plant containing a plant pesticide are as follows:
1. Exemption from requirement of tolerance (food/feed).
2. Registration.
3. Labeling.
Exported plant pesticides that are not exempt from FIFRA regulation are subject to the EPA Export Policy.
The data requirements to support an experimental use permit or registration of a transgenic plant containing a plant pesticide are as follows:
1. Product analysis.
2. Human health effects.
3. Environmental fate.
a. Biological fate analysis.
b. Chemical fate analysis.
c. Environmental fate risk issues.
d. Exposure to the pesticidal substance produced by plant.
4. Ecological effects.
The EPA is discussing the release of a Pesticide Registration Notice promulgating an insect resistance management policy for Bt crops.
Premanufacture Notification And Review Of Microbial Biotechnology Products
EPA promulgated a final rule under section 5 of the Toxic Substances Control Act (TSCA) to establish reporting procedures for the review of certain new microorganisms before they are introduced into commerce. These “new microorganisms” are defined as those which are formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. The rule, which went into effect in June 1997, provides review and notification procedures under section 5 of TSCA. These procedures are comparable to those for traditional chemicals but are tailored to characteristics specific to biotechnology products. (40 CFR Parts 700, 720, 721, 723, and 725.)
The regulations apply to commercial manufacturers and processors of microorganisms subject to TSCA jurisdiction. Regulated activities and entities include:
- Biotechnology research and development activities involving commercial funds for biofertilizers, biosensors, biotechnology reagents, commodity or specialty chemical production, energy application, waste treatment or pollutant degradation, and other TSCA subject uses.
- Manufacturers, processors, or importers of commercial biotechnology products, such as those listed above.
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