UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL 7001 1140 0001 4913 XXXX Name Company Street Address City, State; zip code Re: Lindane Tolerances Dear Mr. XXXXXX:

The Environmental Protection Agency ( EPA or the Agency) recently completed a Reregistration Eligibility Decision ( RED) for lindane and has determined that: 1) the use of lindane for seed treatment is likely to result in residues in raw agricultural commodities derived from plants grown from seeds treated with lindane; 2) new tolerances must be established for residues of lindane in food/ feed commodities before the currently registered lindane products may be reregistered; and 3) currently registered seed treatment uses would be eligible for reregistration provided that registrants submit the required data, make changes to the registration terms and conditions as specified in the lindane RED, and EPA is able to establish all required tolerances for residues of lindane in food that meet the safety standard in Federal Food, Drug, and Cosmetic Act ( FFDCA).

The lindane RED was based in part on human health and ecological risk assessments, which were conducted using maximum application rates for lindane seed treatment specified on currently approved labels and data intended to support these uses. The wheat field trial data, submitted in conjunction with a petition ( PP# 9F05057) to establish tolerances for seed treatment uses on wheat, barley, oats, and rye reflect an application rate of 0.033 lb ai/ 100 lb seed, which is lower than the maximum application rate currently permitted on some lindane product labels used in the RED. According to EPA's regulatory files, the maximum label rate for wheat is 0.0426 lb ai/ 100 lb seed and for barley is 0.0375 lb ai/ 100 lb seed; the maximum rate for oats is 0.03125 lb ai/ 100 lb seed and for rye is 0.0328 lb ai/ 100 lb seed. Consequently, the currently available wheat field trial study can be used to support the establishment of new tolerances for lindane in oats and rye at the current maximum application rates that are on the labels. For the tolerances to be established for lindane use on wheat and barley, which would be based on the wheat field trial study, the maximum application rates for wheat and barley seed treatment currently permitted on lindane labels would need to be lowered to 0.033 lb ai/ 100 lb seed or less. 2 Alternatively, additional residue field trials could be conducted for seed treatment at the higher label rates and to support tolerances associated with the higher rates that were used for the lindane RED.

Tolerances for corn and sorghum are supported from a separate field trial study conducted at the appropriate rate. Therefore, no additional field trials or label modifications are necessary to support corn or sorghum tolerances at this time.

Please inform the Agency of your intended course of action in writing by specifying one of the following options within 30 days of receipt of this letter: 1) revise the maximum application rate of labels registered to your company to be no greater than 0.033 lb ai/ 100 lb of seed for lindane treatment of wheat and barley seeds, and submit the revised labels within the same ( eight months from the receipt of the product specific data call in to be issued later) time frame for other label amendments cited in the RED; or 2) conduct residue field trials necessary to support tolerances on wheat and barley that would result from the higher maximum application rates used to determine the eligibility of the wheat and barley tolerances in the lindane RED; or 3) indicate that the maximum labeled application rates for lindane treatment of wheat and barley seeds for your product registrations do not exceed 0.033 lb ai/ 100 lb of seed.

If you have any questions or comments, please contact me directly by phone at ( 703) 308 8172 or by e mail at howard. markt@ epa. gov. If for some reason I am unavailable, please contact Mike Goodis, the Acting Chief of Reregistration Branch 3, by phone at ( 703) 308 8157 or by e mail at goodis. michael@ epa. gov.

Sincerely,

Mark Howard Chemical Review Manager, Reregistration Branch 3, Special Review and Reregistration Division copy: All lindane registrants