An overview of pesticide registration.

Pesticides are regulated by the U.S. Environmental Protection Agency (EPA) under two major federal statutes--the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FIFRA, EPA registers pesticides for use in the United States and sets labeling and other regulatory requirements to prevent unreasonable adverse effects on human health and the environment. Under FFDCA, EPA establishes tolerances for pesticide residues in food.

Tolerances are the maximum legally permissible levels of pesticide residue allowed in or on raw agricultural products and in processed food. A tolerance, or an exemption from a tolerance, must be established for every agricultural commodity on which a particular pesticide is used or could come into contact with through the food chain. Tolerances also must be established for any pesticides found inadvertently in processed food, no matter how small the amount. The U.S. Food and Drug Administration (FDA) enforce tolerances for most foods. The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service enforces tolerances for meat, poultry, and some egg products.

Three Types of Pesticide Registrations Exist

Section 3 - Registration:

This is the common type of pesticide registration for a product, which has gone through the entire regulatory process and been granted a full label for specific crops, sites, or uses. After EPA registers a pesticide, states can register pesticides under specific state pesticide registration laws. A pesticide cannot be used legally if it has not been registered with EPA's Office of Pesticide Programs and the specific state where the application is made. States may have more stringent requirements for registering a pesticide. Ultimately, states have primary responsibility (called primacy) for pesticides used within their state borders.

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Section 18 - Emergency Exemption:

* FIFRA authorizes EPA to allow states to use a pesticide for an unregistered use for a limited time if EPA determines that emergency conditions exist. Requests are made for pesticides needed for pest problems that impact production of agricultural goods when no other alternatives for controlling the pest are available. Requests usually involve pesticides that have other approved uses, so EPA scientists have prior understanding of the requested chemical. A state or federal agency submits a request to EPA for situations that appear to meet criteria to be deemed an "emergency condition." If the exemption program involves the treatment of agricultural goods, EPA will establish formal tolerances (maximum allowable residue levels) to cover any pesticide residues in food that may result. As required by the Food Quality Protection Act of 1996 (FQPA), EPA must make the finding that there is "reasonable certainty that no harm" will result to human health from aggregate and cumulative exposure to the pesticide before establishing a tolerance. Tolerances established for emergency exemption uses are time-limited, corresponding to the length of time that treated commodities might be found in channels of trade.

For example, a Section 18 exemption exists for the use of thiophanate-methyl to treat mushroom crops for the control of Mushroom Green mold (Tricoderma aggressivum) in California, Delaware, Maryland, Oregon and Pennsylvania.

Specific Section 18 registrations for your state can be found by searching EPA FIFRA Section 18 Emergency Exemption Database at http://cfpub1.epa.gov/oppref/section18/ search.cfm. Use the number 5 search box, "Search by applicant and date range," and select your state from the pull down menu and type in a date range. All of the Section 18 registrations that have been granted during that time period will be listed.

Section 24(c) - Special Local Needs:

* States have been granted the authority by FIFRA to issue special local needs registrations under certain conditions while EPA is responsible for overall pesticide regulation. Special local need means an existing or imminent pest problem within a state for which the state lead agency, based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide product is not sufficiently available. States may register a new end-use product for any use, or an additional-use of a federally registered pesticide product, if the following conditions exist:

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* The additional use is covered by necessary tolerances or other clearances under the FFDCA.

* Registration for the same use has not previously been denied, disapproved, suspended, or canceled by the EPA administrator, or voluntarily canceled by the registrant subsequent to issuance of a notice of intent to cancel because of health or environmental concerns about an ingredient contained in the pesticide product.

* If new data becomes available that resolves the agency's health or environmental concerns, a Section 24(c) may be submitted.

* Registration is in accord with the purposes of FIFRA.

* If the proposed use or product falls into one of the following categories, the state has determined that it will not cause unreasonable adverse effects on man or the environment:

* Use of a product which has a composition not similar to any federally registered product.

* Use of a product involving a use pattern not similar to any federally registered use of the same product or a product of similar composition.

* Use of a product for which other uses of the same product, or uses of a product of similar composition, have had registration denied, disapproved, suspended, or canceled by the EPA administrator.

More specific information about 24(c) registrations can be found at http://www.epa.gov/opprd001/24(c). Currently, there are no Section 24(c) registrations for products used in mushroom production.

In 1996, FQPA amended both FIFRA and FFDCA to establish a more consistent and protective regulatory scheme based on the best science available. Most notably, FQPA required the re-registration of all pesticide products to meet the new criteria of this act.. The most significant FQPA amendments included:

* Establishing the use of "a reasonable certainty of no harm" as the single health-based standard, eliminating the problem posed by multiple standards for pesticides in raw and processed foods.

* Requiring EPA, when setting tolerances, to consider all non-occupational sources of exposure (such as dietary sources; drinking water; home, garden, and recreational uses; and pet care) and exposure to other pesticides with a common mechanism of toxicity or common mode of action--in other words, pesticides that act in a similar way in humans.

* Requiring EPA to add an additional 10-fold safety factor to address the special sensitivity of infants and children. The EPA can reduce or remove this additional safety factor if available data indicate that the extra safety factor is not needed.

* Preempting states from establishing tolerances that differ from national tolerances, unless state-specific circumstances justify the exemption.

* Narrowing the range of circumstances in which benefits of pesticide use may be considered when setting tolerances and requiring periodic reassessments in order to maintain tolerances.

* Enhancing the enforcement of pesticide residue standards by allow ing the FDA to impose civil penalties for tolerance violations.

In general, the result of this decade-long process has meant the loss of many uses for some pesticides. Under the amendments of FQPA, the re-registration of pesticides will be an ongoing process. When this decision-making process affects chemicals used in mushroom production, growers can have input in the process by providing as much information as possible to the people who make these regulatory decisions. One way to provide input is by completing surveys conducted by commodity groups or university specialists that collect information regarding current use of pesticides in mushroom production. Results from these surveys will be used to help prevent key compounds and uses from being eliminated, and may assist in the process of requesting Section 18 exemptions. In addition, cooperating with or taking an active role in trade associations and commodity groups also will help protect your interests. Finally, your state and federal legislative representatives are key contacts. Corresponding with these individuals can accomplish more than people think since legislators want to hear from their constituents so they can stay in tune with their concerns.

* It is important to note that anyone using a product must also have any supplemental labeling that is available for the uses under Section 18 or 24(c) exemptions.

Kerry H. Richards, Ph.D.

Penn State Director & Affiliate Assistant Professor Pest Management information Center Dept. of Agricultural & Extension Education [e-mail]