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Biopesticides

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Biopesticides (also known as biological pesticides) are pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. 

Related topics
Integrated Pest Management
Pesticides
Pollution Prevention, Best Management Practices, and Conservation
Sustainability

Related publications from the Ag Center
Biopesticides
Integrated Pest Management
Organic Farming
Pesticides
Pollution Prevention, Best Management Practices, and Conservation
Sustainability

Related laws and policies
Federal Insecticide, Fungicide, and Rodenticide Act
Food Quality Protection Act (FQPA)

Related environmental requirements
PIP Regulations under FIFRA (40 CFR Part 152 and 40 CFR Part 174)
PIP Regulations (DNA exemption) under FFDCA (40 CFR Part 174)
PIP Regulations (conventional breeding exemption) under FFDCA (40 CFR Part 174)
Federal Insecticide, Fungicide, and Rodenticide Act text Exit EPA
Pesticide Regulations: 40 CFR Parts 152 - 180
Federal Food, Drug, and Cosmetic Act (FFDCA) Exit EPA
Food Quality Protection Act (FQPA)

More information from EPA
Biopesticides
Biopesticides fact sheets
Tips for Avoiding Confidential Statement of Formula or Product Chemistry Issues With Biopesticides
EPA Quarantine Exemptions for Light Brown Apple Moth Pheromones

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Types of Biopesticides

Biopesticides fall into three major classes:

Microbial pesticides consist of a microorganism (e.g., a bacterium, fungus, virus, or protozoan) as the active ingredient. Microbial pesticides can control many different kinds of pests, although each separate active ingredient is relatively specific for its target pest[s]. For example, there are fungi that control certain weeds, and other fungi that kill specific insects.

The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different mix of proteins, and specifically kills one or a few related species of insect larvae. While some Bt's control moth larvae found on plants, other Bt's are specific for larvae of flies and mosquitoes. The target insect species are determined by whether the particular Bt produces a protein that can bind to a larval gut receptor, thereby causing the insect larvae to starve.

Plant pesticides are pesticidal substances that plants produce from genetic material that has been added to the plant. For example, scientists can take the gene for the Bt pesticidal protein and introduce the gene into the plant's own genetic material. Then the plant, instead of the Bt bacterium, manufactures the substance that destroys the pest. Both the protein and its genetic material are regulated by EPA; the plant itself is not regulated.

Biochemical pesticides are naturally occurring substances that control pests by non-toxic mechanisms. Conventional pesticides, by contrast, are generally synthetic materials that directly kill or inactivate the pest. Biochemical pesticides include substances, such as insect sex pheromones, that interfere with mating, as well as various scented plant extracts that attract insect pests to traps. Because it is sometimes difficult to determine whether a substance meets the criteria for classification as a biochemical pesticide, EPA has established a special committee to make such decisions.

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Advantages of Biopesticides

To use biopesticides effectively, however, users need to know a great deal about managing pests.

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EPA Encourages the Development and Use of Biopesticides

In 1994, the Biopesticides and Pollution Prevention Division was established in the Office of Pesticide Programs to facilitate the registration of biopesticides. This division promotes the use of safer pesticides, including biopesticides, as components of IPM programs. The division also coordinates the Pesticide Environmental Stewardship Program (PESP).

Since biopesticides tend to pose fewer risks than conventional pesticides, EPA generally requires much less data to register a biopesticide than to register a conventional pesticide. In fact, new biopesticides are often registered in less than a year, compared with an average of more than three years for conventional pesticides.

While biopesticides require less data and are registered in less time than conventional pesticides, EPA always conducts rigorous reviews to ensure that pesticides will not have adverse effects on human health or the environment. For EPA to be sure that a pesticide is safe, the Agency requires that registrants submit a variety of data about the composition, toxicity, degradation, and other characteristics of the pesticide.

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Plant-Incorporated Protectant Rules

Three final rules explain EPA’s framework for federal oversight of plant-incorporated protectants, which include plants engineered through biotechnology to express pesticidal properties. Plant-incorporated protectants act like pesticides and are produced and used by a plant to protect it from pests, such as insects, viruses, and fungi. These rules define the type of plant-incorporated protectants (PIPs) that are required to undergo scientific evaluation to ensure protection of human health and the environment.

The rule includes two pesticide tolerance exemptions under the Federal Food, Drug, and Cosmetic Act (FFDCA), a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) rule, and a supplemental notice. The FIFRA rule, also known as the biotechnology rule, was formerly called the plant-pesticides rule. These rules change the names of these pesticides from plant-pesticides to plant-incorporated protectants (PIPs).

The plant-incorporated protectant rules largely formalize the Environmental Protection Agency’s existing process for regulating plant-incorporated protectants and do not change significantly EPA’s current system for scientifically evaluating a plant-incorporated protectant.

The rules clarify which plant-incorporated protectants are required to be evaluated under FIFRA and FFDCA and which plant-incorporated protectants are exempt.

Under the rules, most components of plant-incorporated protectants derived from genetic engineering will be subject to FIFRA and FFDCA requirements. (Certain components of the genetic material necessary for the production of plant-incorporated protectants will be exempt from the requirement for a tolerance under FFDCA)

Where the Agency has determined that plant-incorporated protectants pose little or no health and environmental risk, EPA has issued the following exemptions from certain requirements:

The exemptions not finalized address:

Related publications from the Ag Center
Biopesticides
Pesticides

Related environmental requirements
Plant-Incorporated Protectant Rules
PIP Regulations under FIFRA (40 CFR Part 152 and 40 CFR Part 174)
Federal Food, Drug & Cosmetic Act 408-409 Exit EPA
PIP Regulations (DNA exemption) under FFDCA (40 CFR Part 174)
PIP Regulations (conventional breeding exemption) under FFDCA (40 CFR Part 174)

More information from EPA
USDA, EPA, FDA Release Statement on Genetically Engineered Corn "Event 32"
Biopesticides
Plant-Incorporated Protectant Rule Package Fact Sheet (PDF) (2 pp, 20K)
Q&A on the Biotechnology Final Plant-Incorporated Protectants Rules (PDF) (5 pp, 40K)
Tips for Plant-Incorporated Protectant Experimental Use Permit Program Submission
Pesticide Registration (PR) Notice 2007-2: Guidance on Small-Scale Field Testing and Low-Level Presence in Food of Plant-Incorporated Protectants
Natural Refuge for Insect Resistance Management in Bollgard II Cotton

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At the strong urging of the Environmental Protection Agency, Aventis announced on October 12, 2000, that they are canceling the registration of StarLink corn. This means that Starlink corn can no longer be planted for any agricultural purpose. The agreement will ensure that in the future no new StarLink corn will be grown and none will find its way into processed foods like taco shells.

The voluntary agreement represents far and away the fastest tool available to EPA for quickly removing StarLink corn from being planted for any agricultural uses. This action will ensure the full protection of public health and continued consumer confidence in the food supply.

EPA does not have any evidence that food containing StarLink corn will cause any allergic reaction in people, and the agency believes the risks, if any, are extremely low. However, because Aventis was responsible for ensuring that StarLink corn be used only in animal feed, and that responsibility clearly was not met, the action was necessary. The remaining StarLink corn must be used only for animal feed or industrial uses until existing stocks are depleted.

EPA commends both Kraft Food and Safeway for the quick response they have taken to remove from sale taco shells suspected to contain StarLink corn.

More information from EPA
SAP Final Report: Assessment of Additional Scientific Information Concerning StarLink Corn (PDF) (39 pp, 114K)

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Conditional Registration of Bt Cotton Reaffirmed

Based on a comprehensive scientific review, corn genetically modified with Bacillus thuringiensis (Bt) has been approved for an additional 7 years. Bacillus thuringiensis is a naturally occurring soil bacterium that produces a protein toxic to certain insects, which has been used for many years to control insect pests. Incorporating the genetic material from Bt into corn plants enables the plants to produce the same toxin and defend against several pest species. Scientific studies and a history of successful use have demonstrated that Bt is not toxic to humans or other animals.

The renewed registrations of the five Bt corn products continue to include specific requirements for companies to routinely monitor and collect data to ensure that the products' continued use does not lead to insect resistance or unexpected human health or environmental effects. In order to ensure that Bt corn continues to be a safe and effective tool for farmers, EPA has also mandated several provisions to strengthen insect resistance management, to increase research data on potential environmental effects, and to improve grower education and stewardship.

After a nearly 2-year long review process, EPA determined that Bt corn will not pose unreasonable risks to human health or to the environment. Of particular concern during this process were the potential risks to Monarch butterflies. In investigating these risks, the Agency requested extensive data from the scientific community in order to better evaluate the potential concern. The scientific evidence demonstrates that Bt corn does not impact Monarch butterfly populations. EPA has also determined that there will be no effects to endangered species from the use of the currently registered Bt corn products.

In extending the use of Bt corn, EPA has increased environmental and compliance monitoring requirements. Specifically, EPA is requesting additional data on the persistence of the active protein in soil, field studies on non-target insects, studies examining long-term effects on Monarch butterfly population, an additional feeding study for bird species, and monitoring of the behavior of particular pest populations and their north-south movement through the country.

Companies marketing Bt corn seed will be required to monitor for the development of insect resistance, provide annual reports on the efficacy of resistance management plans, and implement remedial action plans in the event that resistance is detected among pest populations. The companies must also educate growers about the best methods of planting Bt corn to minimize any potential development of insect resistance. To enhance grower stewardship and compliance with the insect resistance management provisions, all growers must sign contractual grower agreements. These agreements, coupled with the grower guides, set forth the terms and conditions for use. Companies are now required to implement a system to secure signature of the grower agreements prior to receipt of any seed, and to make the grower agreements available to EPA. To monitor the enhanced requirements, an independent, third party compliance survey of licensed growers will be conducted annually for the duration of the registrations.

Before reaching this decision, EPA undertook an extensive evaluation of the previous time-limited registrations for these plant-incorporated protectants. A careful review of scientific information confirms previous findings that these Bt corn varieties show no evidence of allergenicity. The Agency consulted with an independent panel of scientific experts from the academic and medical communities, which conducted scientific peer review on key issues.

More information from EPA
EPA's Regulation of Biotechnology for Use in Pest Management
Biopesticides Registration Action Document - Bt Plant-Incorporated Protectants

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Bt Cotton Refuge Requirements for the 2001 Growing Season

Growers must chose one of three structural refuge options for the 2001 growing season:

95:5 External Structured Unsprayed Refuge
At least 5 acres of non-Bt cotton (refuge cotton) must be planted for every 95 acres of Bt cotton. This refuge may not be treated with any insecticide labeled for the control of tobacco budworm, cotton bollworm, or pink bollworm. The refuge must be at least 150 feet wide. The refuge must be managed (fertility, weed control, and management of other pests) similarly to Bt cotton. The refuge must be planted within ½ linear mile from the edge of the Bollgard® cotton field.

80:20 External Sprayed Refuge
At least 25 acres of non-Bt cotton must be planted for every 100 acres of Bt cotton. All cotton may be treated with insecticides (excluding foliar Bt products) labeled for control of the tobacco budworm, cotton bollworm, or pink bollworm. Ensure that a refuge is maintained within 1 linear mile (preferably within ½ mile) from the edge of the Bt cotton.

95:5 Embedded Refuge
At least 5 acres of non-Bt cotton (refuge cotton) must be planted for every 95 acres of Bt cotton. The refuge cotton must be embedded as a contiguous block within the Bt cotton field. For very large fields, multiple blocks across the field may be used. For small or irregularly shaped fields, neighboring fields farmed by the same grower can be grouped into blocks to represent a larger field unit, provided the block exists within 1 mile squared of the Bt cotton and the block is at least 150 feet wide. Within the larger field unit, one of the smaller fields planted to non-Bt cotton may be used as the embedded refuge. This refuge may be treated with any insecticide (excluding foliar Bt products) labeled for the control of tobacco budworm, cotton bollworm, or pink bollworm whenever the entire field is treated. The refuge may not be treated independently of the Bt cotton field.

For areas affected by pink bollworm only, the refuge cotton may be planted as single rows within the Bt cotton field.

In cases where placement of the refuge within 1 mile of the Bt cotton would be in conflict with state seed production regulations, the grower must plant the refuge as close to the Bt cotton as allowed.

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Genetic Engineering

Definition: Genetic engineering (GE) is one of a group of technologies generally referred to as "biotechnology". Genetic engineering refers to the transfer of individual genes between unrelated species, through the use of "recombinant DNA (rDNA) techniques."

At least in theory, genes from any living organism may be transferred to any other living organism using rDNA techniques. In fact, genes from toads have been integrated into potatoes, bacteria into corn, fish into tomatoes, and human genes have been placed in trees, pigs, rats, and bacteria. The resulting GE organisms (GEOs) are also termed "transgenic".

Goal: The goal of genetic engineering is to:

How is it done? GE is a laboratory procedure in which genetic material is extracted from cells of a "donor" organism, injected into the egg of an animal or (using a variety of other methods) inserted into cells of a plant "host" organism. Transgenic eggs are placed in surrogate mothers and transgenic plant cells are then grown into adult plants. Those with the best commercial properties are then selected.

Several aspects of this technique are important to the issues being raised about genetic engineering: 

Risks: Because the technology is new, its risks are not fully understood. However, it is apparent that GEOs may potentially:

Regulation: There are no laws specific to GEOs; instead, they are regulated under existing statutes by the Food and Drug Administration, the US Department of Agriculture and EPA. FDA regulates GE foods, drugs, cosmetics, and medical devices; USDA regulates GE plants that might become agricultural pests; and EPA regulates GE plants expressing pesticidal properties, as well as microorganisms engineered to produce industrial chemicals.

More information from USDA Exit EPA
USDA APHIS Biotechnology Regulatory Services

More information from other organizations Exit EPA
Information Systems for Biotechnology

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