Region 1: EPA New England

Information for Pesticide Manufacturers...

Registration   Pesticide ReRegistration Status		Inert Ingredients   Reporting Production Requirements
	Biopesticides

Registration

EPA is responsible under FIFRA for registering new pesticides to ensure that, when used according to label directions,they will

Resources Links     EPA Office of Pesticide Programs - Registration Division Label Review Manual Pesticide Labels and Labeling

pose no unreasonable risks to human health or the environment. No pesticide may legally be sold or used in the United States unless it bears an EPA registration number. It is a violation of the law for any person to use a pesticide in a manner inconsistent with its EPA approved labeling. At this time three divisions within the Office of Pesticide Programs are responsible for registration of various types of pesticide products. The Registration Division is responsible for registering most conventional chemical pesticides. The Antimicrobial Division is responsible for registration of antimicrobial products as well as antifouling paints and wood preservatives. The Biopesticides and Pollution Prevention Division is responsible for registration of genetically engineered plant-pesticides and other biological pesticides.

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Pesticide ReRegistration Status (ReREDs)

EPA is required by law to reregister existing pesticides that were originally registered years ago when the standards for government acceptance were less stringent than they are today. In 1988 Congress amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to strengthen and accelerate EPA's reregistration program. At that time, under "FIFRA'88" Congress provided EPA with resources and a timetable to reregister all products containing any active ingredient which had been originally registered before November 1, 1984. The reregistration process ensures that:

1. Up-to-date data bases are developed for each of these chemicals (or their registrations will be suspended or canceled);
2. Modifications are made to registrations, labels, and tolerances (allowable residues on food) as necessary to protect human health and the environment; and
3. Special review or other regulatory actions are initiated to deal with any unreasonable risks.

Following completion of the reregistration eligibility review and decisions on the pesticide chemical cases, the Agency publishes the results of it's findings in a document called a Reregistration Eligibility Decision (RED) for the individual chemical.

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Inert Ingredients

In addition to containing active ingredients, virtually all pesticide products contain one or more other ingredients which are called inert ingredients. The Office of Pesticide Programs defines an inert ingredient as "an ingredient in a pesticide that has no direct pesticide activity but can be biologically active (e.g., water, solvents, emulsifiers, surfactants, clay or propellants)." Prior to 1987, the majority of inert ingredients had received EPA clearance with less scientific scrutiny than is applied today.

EPA is committed to finding ways of making information on inert ingredients more available to the public while working within the mandates of the FIFRA and related Confidential Business Information concerns. EPA is exploring options for increasing inert disclosure in cooperation with key stakeholders of the Pesticide Program Dialogue Committee (PPDC). The PPDC is an official government advisory committee and is composed of approximately 25 members from the pesticide industry, user and commodity groups; Federal and State governments; consumer and environmental/public interest groups, including representatives from the general public; academia; and public health organizations. PPDC provides advice and guidance to OPP regarding pesticide regulatory, policy, and implementation issues.

In 1987, EPA published an Inerts Strategy, which calls for the use of the least toxic inert ingredients available. For new inerts, clearance requests must include a "base set" of data that allows EPA to determine whether or not exposure to the inerts will result in unreasonable adverse effects. Existing inerts have been categorized into four groups based on their known toxicity and the need for additional toxicity testing.

List 1 ingredients, "inerts of toxicological concern," were required to be disclosed on the labels of pesticide products containing these ingredients. As of October 1997, there are only eight List 1 inerts which are used in some 160 products (versus 57 inerts of toxicological concern in approximately 1300 products in 1987). In response to an inert Data Call-In Notice (DCI), data and waivers are under review for six of these chemicals; the two remaining inerts (formaldehyde and hydroquinone [used solely to stabilize the active ingredient acrolein]) are undergoing reregistration.

List 2 inerts are "potentially toxic with a high priority for testing." Of the original 64 List 2 inerts present in over 9,000 products, about 15 are no longer used in pesticide products. The Agency is reviewing the available data to determine if any of these chemicals meet the triggers for inclusion on the List 1 or have sufficient data to support a reclassification to List 4B.

List 3 "inerts of unknown toxicity", includes approximately 1500 chemicals. OPP is currently developing toxicological and ecological assessments for these inerts.

List 4 "inerts of minimal concern" are divided into two groups: List 4A representing minimal risk inerts or "generally regarded as safe", and List 4B representing ingredients for which "sufficient information to conclude that their current use patterns in pesticide products would not adversely affect public health and the environment". In 1995, approximately 150 inert ingredients were reclassified from List 3 to List 4.

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Biopesticides

Introduction
Biopesticides are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and minerals. For example, canola oil and baking soda have pesticidal applications and are considered biopesticides. At the end of 1998, there were 175 registered biopesticide active ingredients and 700 products. Biopesticides fall into three major classes:

1. Microbial pesticides contain a microorganism (e.g., a bacterium, fungus, virus or protozoan) as the active ingredient. Microbial pesticides usually have a narrow range of pests that they are effective against. Different types of microbial pesticides are available for many different kinds of pest organisms; for example, there are fungi that control weeds, other fungi that control cockroaches, and bacteria that control plant diseases. The most widely used microbial pesticides are various types of the bacterium Bacillus thuringiensis, or Bt, which can control specific insects in cabbage, potatoes, and corn.
2. Plant-pesticides are 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 it into the plant's own genetic material. Then the plant manufactures the substance that destroys the pest.
3. Biochemical pesticides are naturally occurring substances that control pests by non-toxic mechanisms. They include substances, such as sex pheromones, that may be used to interfere with mating of the pest.

Advantages of using biopesticides
The EPA's Office of Pesticide Programs believes that Biopesticides generally present lower risks than conventional pesticides. Biopesticides are more likely to affect only the target pest and closely related organisms in contrast to broad spectrum conventional pesticides that may affect many organisms as different as birds, insects, and mammals. Biopesticides often are effective in very small quantities and often decompose quickly, thereby resulting in lower exposures and largely avoiding the pollution problems caused by conventional pesticides. Biopesticides often fit well within Integrated Pest Management (IPM) programs which may include a mix of chemical, biological, and mechanical controls and can lead to overall risk reduction in agricultural and non-agricultural settings.

How does EPA encourage the development and use of biopesticides?
The Biopesticides and Pollution Prevention Division (BPPD), established in the Office of Pesticide Programs as part of the efforts to streamline government, is responsible for registering biopesticides and promoting reduced pesticide use and risk, including biopesticides, as components of IPM programs.

EPA's regulation of biopesticides
In 1986, the Federal government produced a document called the "Coordinated Framework for Biotechnology" in which it was made clear that the regulation of pesticidal substances produced through biotechnology would be regulated by EPA under the pesticide laws. The principle laws for regulating pesticides are the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA). Both of these laws were amended by the Food Quality Protection Act of 1996. FIFRA defines a pesticide as: (1) any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, and (3) any nitrogen stabilizer.

FIFRA is also an "intent" law which means that if someone is intending that a substance be used to control a pest, the substance is a pesticide whether it is a substance produced through a chemical manufacturing process, a fermentor, or a living plant. Also, FIFRA states that either sale or distribution of the pesticide requires the substance to be regulated.

Bioiopesticides Registration Tools

Biopesticides