TYPES OF REGISTRATION

Kentucky law requires EPA registered products to be registered also by the state. This state registration regulates the sale or use of a pesticide and is permitted by federal law as long as it does not allow any sale or use prohibited by FIFRA, or impose any requirements for labeling or packaging in addition to or different from those required by FIFRA.

EPA can grant Experimental Use Permits (EUP) to collect information needed for initial registration or to add a new use to the current label. Most EUPs are obtained by the company wishing to register the pesticide. Experiment Station and Cooperative Extension personnel who test unregistered pesticides generally do so under the experimental use permit of the company producing the pesticide.

EUPs are not required just to test substances for pesticidal properties, toxicity, or other properties. This includes not only laboratory and greenhouse trials but also:

• Land use: where tests are conducted on less than 10 total acres and any food or feed crop used is destroyed or consumed by experimental animals unless a tolerance or exemption from a tolerance has been established.
• Aquatic use: where tests are conducted on less than one surface-acre of water and the water is not used for irrigation, drinking, water supplies, or body contact recreational purposes. No tests may be conducted in any waters where fish, shellfish, or other plants and animals are taken for recreation or commercial purposes and used for food or feed, unless a tolerance or exemption from a tolerance has been established.
• Animal treatments: conducted only on experimental animals. No animals can be tested if they may be used in food or feed, unless a tolerance or exemption from a tolerance has been established.

Pesticide labels and labeling are among the most important documents that pesticide applicators have. The label refers to any information printed on the product container. Labeling refers to any information that is attached to or accompanying the product at the time of purchase. The pesticide user is legally responsible to follow all label directions. Under the "Directions for Use" section of the label there usually is a statement that says: "It is a violation of Federal Law to use this product on a manner inconsistent with its labeling." The user is personally liable if a pesticide application results in unwanted damage.

While "the label is the law", some allowances are permitted. Under Section 2ee of amended FIFRA it is legal to:

1. apply a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the label prohibits the deviation
2. apply a pesticide against any target pest not specified on the labeling if the crop, animal, or site is specified on the labeling and the labeling does not prohibit the use. (The Administrator of the EPA may require that the label specifically state that the pesticide may be used only for pests specified on the labeling if the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment.)
3. use any method of application that is not prohibited by the labeling
4. mix a pesticide or pesticides with a fertilizer when the mixture is not prohibited by the labeling.
5. apply according to uses authorized by Section 18 or 24-c registrations
6. apply according to uses which the Administrator of EPA determines to be consistent with amended FIFRA.

The lack of registered pesticides for use on small acreage crops, such as ornamental trees, shrubs and flowers, has always been a problem for growers, commercial applicators and homeowners. Many specialty crops cannot be produced economically or with the quality that markets demand without some use of pesticides. However, the registration process is costly. Gathering the additional data needed for registration increases the time required for developing a new product and obtaining the necessary information on tolerances and residues. The relatively low financial return in proportion to effort and cost may cause a company to abandon plans to register a product for a minor crop use and only to seek registration of the pesticide only for large acreage crops.

Before 1972, pesticides that were sold and used entirely within a state were not subject to Federal regulations. Many minor or specialty crop uses of pesticides were taken care of by state registration because the often small companies with these products were unable to provide the information necessary for Federal registration. This resulted in the loss of many minor or specialty crop uses. In addition, pesticides that were registered before 1972, now are going through a reregistration process. In 1972, the data requirements to register a pesticide increased substantially. Most companies faced with the reregistration process have greatly reduced the labels of these products to cover only major crops or high volume uses.

There are a few methods that have been established to help aid the minor or specialty crop use problems.

Interregional Research Project No. 4) (IR-4) is a cooperative effort among the USDA, EPA, State Experiment Stations, and the pesticide industry to accumulate the data necessary to obtain minor use labels for currently registered pesticides. This may involve the addition of a new crop to the label or to allow changes in rate, timing, or application method. For food or feed crops, the major task of the IR-4 project is to obtain a residue tolerance. This can only be done if there is at least one existing tolerance for the pesticide in question. The UK Agricultural Experiment Station cooperates with IR-4 projects.

Section 24 (c) of FIFRA permits the Kentucky Department of Agriculture to register federally registered pesticides for some uses that are not on the existing label. These 24-c or State Labels, are valid only in the state of issue. The applicator must possess a copy of the state label when the pesticide is applied. In Kentucky, 24-c labels must be renewed annually.

When there is an existing or expected local or minor pest problem, the Kentucky Department of Agriculture will be permitted to register one or more pesticide products if:

• there is no EPA-registered pesticide for the use in question.
• the EPA-registered pesticide is not available or cannot be obtained in sufficient quantity.
• there is an EPA-registered pesticide which, nominally is suitable, but if used in accordance with the label, would not be safe or effective under the local conditions.

States cannot register:

• pesticides on food crops that do not have an established tolerance on that crop.
• pesticides containing active or inert ingredients not contained in any EPA-registered products.
• pesticide products or uses affected by suspension or cancellation based on human health, environmental, or efficacy considerations.
• pesticide products and/or uses previously denied registration by EPA.

Special local needs registrations may be sought by commodity groups, Cooperative Extension Service personnel, and others. The pesticide manufacturer or formulator must, however, be willing to register or add the use in question to the product's label for p84 use in the state. People or groups making the request must work with the manufacturer or formulator to develop the information needed to support the registration request.

The Administrator of the EPA may, at is discretion, exempt any Federal or State agency,

It is illegal to apply a pesticide unless it has the appropriate label for the use or purpose. Situations can occur for which there are no registered pesticides. For example, a serious outbreak of a new or previously minor pest may occur on a crop for which no registered pesticide is available. If it is a food crop and no tolerance exists for it, a state 24(c) label cannot be granted.

FIFRA provides for the emergency use of pesticides in these situations. A state may obtain permission to use an unregistered pesticide in an emergency situation when

1. no effective registered pesticides are available to control the pest problem;
2. no feasible alternative control practices are available;
3. and 3) the situation involves the intorduction of a new pest or will present significant risks t human health or the environment or will cause significant economic loss.

FIFRA provides for three types of exemptions:

1. Specific Exemption

   If a pest outbreak has occurred or is about to occur and no effective pesticides are registered for that use or purpose, the Kentucky Department of Agriculture may ask for an exemption to use a specific pesticide. Information including the nature, scope, and the frequency of the problem, the pest involved, which pesticide or pesticides will be used and in what amounts, the economic benefits anticipated, and an analysis of possible adverse effects must be supplied. The EPA grants the exemptions. Reports must be filed when the treatment is over. A specific exemption is only good for a specified amount of time and for a designated area.

2. Quarantine or Public Health Exemption

   This exemption may be granted to prevent the introduction or spread of a foreign pest into or throughout the US or to prevent a public health problem. No pesticide that has been suspended by EPA may be used.

3. Crisis Exemption

   A crisis exemption may be used if a registered pesticide is not readily available to control or eradicate the pest and if there is not time to obtain a specific exemption. No pesticide that has been suspended or canceled may be used. The Administrator of EPA must be notified within 36 hours. Within 10 days of the use, the state must file information similar to that required for the specific exemption.

Cancellation or Reclassification

The EPA can issue a notice of intent to cancel or reclassify (as general or restricted use), or can hold hearings on the proposed changes if:

• the pesticide, its labeling, or supportive data required to be submitted does not comply with FIFRA.
• the pesticide generally causes unreasonable adverse effects on the environment when it is used in accordance with a widespread and commonly recognized practice. The pesticide being evaluated can be manufactured, shipped, sold and used until the EPA makes a final decision. If the pesticide is canceled, the EPA usually allows the existing supplies to be used according to the label until they are exhausted. p84 Suspension

If the Administrator of EPA decides that action is necessary to prevent an imminent hazard during the time required for the cancellation issue to be settled, he may suspend the registrations of the pesticide immediately. A suspension order cannot be issued unless an intent to cancel the pesticide registration is filed at the same time or has been filed previously.

A benefits and risks assessment is a process which deals with pesticide registration, and/or classification. Extension specialists and Experiment Station researchers have been asked to assist in providing information and data to support the continued registration of certain pesticides that are going through the review process. If a pesticide shows potentially dangerous characteristics, it is subjected to intensive scientific review and public comment before a decision is made on whether to allow continued use or begin the process of removing it from the market by cancellation or suspension.

The criteria that trigger a review are: if the pesticides is highly toxic and may pose the threat of immediate poisoning to people or wildlife, if it may cause serious long-term health problems such as tumor formation or mutations in people or "non-target" animals, if the pesticide lacks an emergency first-aid treatment, or occurs as excess residues on feeds.