Experimental use permit

In general, the labeling requirements for pesticides shipped and used under an experimental use permits (40 CFR 172.6) represent a skeleton version of the requirements for registered pesticides. 

---

Pesticide Assessment Guidelines, Data Requirements Subdivision D, Product Chemistry E, Ha ard Evaluation—Wildlife and Aquatic Organisms F, Ha ard Evaluation—Human and Domestic Animals G, Product Peformance H, Eabeling , Experimental Use Permits J, Ha ard Evaluation—Nontafget Plants K,... 

For protection of public health, there must be some control of the experimental use of pesticide chemicals in obtaining data necessary for registration of a marketable product. Experimental use permits are issued under provisions, at 40 USC 136c, of the Federal Insecticide, Fungicide, and Rodenticide Act. Either temporary tolerance or an exemption can be granted with a permit. When the EPA takes such action, a notice is published in the Federal Register (Schultz, 1981). 

Field evaluation of bromethalin. Both indoor and outdoor field trials against Norway rat and house mouse populations were conducted under an EPA experimental use permit in a number of geographical locations in the U.S.( 15,16) In all cases 0.005% bromethalin was used in a bait containing 65% corn meal, 25% rolled oats, 5% sugar and 5% corn oil(E.P.A. diet). 

An application for an experimental use permit under FIFRA section 5. 

Hereon Division of Health-Chem Corporation has been awarded registrations or experimental use permits by the U.S. Environmental Protection Agency for mating disruptant products for the following insect species. 

During 1981-83 field experiments were conducted in single family residences and in apartment complexes in several locations in the USA in compliance with Experimental Use Permits (E.U.P. s) from the... 

New pesticides (not previously registered) can be tested in the field without registration under "experimental use permits." This is essential if we are to continue to develop new products. 

Pesticides are specifically exclnded from TSCA s definition of a chemical snbstance, when mannfactured, processed, or distributed as a pesticide. EPA generally considers a prodnct to be a pesticide once it requires a FIFRA (Section 5) Experimental Use Permit. It is important to note that inerts and raw materials are not considered pesticides nntil they become part of a pesticide prodnct. Intermediates nsed in the mannfacture of a pesticide are not excluded from regulation under TSCA, nnless they are pesticides themselves and ate being nsed in a mixture for their pesticidal properties, or are not isolated dnring the manufacturing process. 

As mentioned above, a product becomes a pesticide once it has received an Experimental Use Permit. This interpretation means that chemicals that are being tested in the laboratory or in small field trials are regulated by TSCA. However, current OTS policy is to exempt such activities from submission of risk information, notification, and recordkeeping, provided the requirements in 40 CFR 720.36 are met. 

EPA Review Process for the Advanced Genetic Sciences and University of California (Dr Lindow) Experimental Use Permit Application,... 

Experimental Use Permits, Title 40 Code of Federal Regulations,... 

Advanced Genetic Sciences Experimental Use Permit Application,... 

R = REOUIRED CR = CONDITIONALLY REQUIRED UNDERLINE (R, CR) INDICATES DATA REQUIREMENTS WHEN AN EXPERIMENTAL USE PERMIT IS SOUGHT. 

Under Section 5 of FIFRA, EPA may issue experimental use permits (EUPs) to pesticide registrants. These EUPs permit large scale experimentation to develop data for new pesticides or new uses of currently registered pesticides. In many cases the crop subjected to the experimental pesticide is destroyed. If the crop will be marketed after the experimental program is completed, a temporary tolerance for a safe residue level on the food or feed commodity must be established by the Agency before the EUP is issued. Both EUP and temporary tolerance decisions are based on an evaluation on human and environmental risks and benefits associated with a proposed use. 

Handbook of Chemical Industry Labeling LABEUNG FOR EXPERIMENTAL USE PERMITS... 

IU.S. EPA, 1985. Experimental Use Permits Title 40, Code of Federal Regulations, Part 172. 

Table II. Sunroary of microbial pesticide notifications and experimental use permits... 

To approve an experimental use permit, for an herbicide for corn, for an insecticide for coniferous trees, for a soil sterilant, what studies should be required ... 

RESPONSE EPA agrees that they would not normally be reportable because the exposure is not widespread and previously unsuspected. However, if health or environmental effects are seen then reporting should be considered. Also, if the substance has started the regulatory review process under FIFRA it would not be subject to section 8(e) reporting. A chemical substance which is in the process of R D as a pesticide is subject to TSCA until such time as the manufacturer or importer demonstrates the intent to produce a pesticide by submitting to the Agency an application for an Experimental Use Permit or registration under FIFRA. 

Fed. Reg. 15096,15098 (Apr. 22.1986). This final rule adds in the preamble that pesticidal intent is demonstrated when the manufacturer files an Experimental Use Permit under the Federal Insecticide, Fungicide, and Rodenticide Act. 7 U.S.C. 136. However, if there are both pesticidal and non-pesticidal uses for the R8rD substance then the requirements of the R8cD exemption must be followed. 

---