US Environmental Protection Agency EPA

Under FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act), biological pesticides (also known as biopesticides) are regulated by the EPA's Biopesticide Pollution and Prevention Division. Biopesticides fall into the categories of "microbials" and "biochemicals."

Microbial pesticides contain a microorganism (e.g., a bacterium, fungus, virus, or protozoan) as the active ingredient. The most widely used microbial pesticides are various types of the bacterium Bacillus thuringiensis, or Bt. Biochemical pesticides are naturally occurring substances that control pests by nontoxic mechanisms. Biochemicals include products, such as pheromones, that interfere with pests' growth or mating patterns, and certain plant growth regulators that increase the productivity of many crops.

Products can be registered as biochemicals provided the active ingredients are natural or derived from a natural source, show no direct toxic effects, and have a specific, nontoxic mode of action. Biopesticides (microbials and biochemicals) can take considerably less time and money to bring to market than synthetic chemicals (3 years and $3 million to $6 million versus >10 years and $185 million for synthetic chemicals).

Each new biopesticide must go through Tier I toxicology, ecotoxicology, and end product (final formulation) tests. If there are no direct toxic effects in these tests, no further testing is required.

The following data are required for registering a biopesticide active ingredient:

• Product chemistry, batch analysis

• Microbiology/human pathogens

• Acute toxicity/pathogenicity

• Ecological effects (nontarget birds, fish, invertebrates, insects, plants)

• Primary dermal and eye irritation

The following data are required for registering a biopesticide "end use'' (formulated):

• Product chemistry/storage stability

Acute oral LD50 Acute dermal LD50 Primary eye irritation Primary dermal irritation Hypersensitivity Acute inhalation

The FFDCA (Federal Food, Drug, and Cosmetic Act) requires a tolerance for all chemical pesticides (a limit on the amount of chemical allowed in a fresh or processed food). All biopesticides registered so far have been exempt from tolerance because of their safety.

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