[EPA press release - November 7, 1989]

The U.S. Environmental Protection Agency today announced that it intends to approve the request of Uniroyal Chemical Co. Inc. of Bethany, Connecticut, to voluntarily cancel all food-use registrations of the pesticide daminozide (trade name Alar). EPA will order a prohibition on all sales, distribution and use of daminozide products labeled for use on food crops, including existing stock, effective three days after publication in the Federal Register, which is expected on November 15.

The cancellation order will require Uniroyal to complete and submit final reports of three cancer studies involving a breakdown product of daminozide, unsymmetrical dimethylhydrazine (UDMH). The only study that is still ongoing is scheduled to be reported to the Agency by January. EPA also announced today that it will terminate the special review of daminozide for food uses. However, the special review of daminozide for use on ornamental plants, the remaining registration, will continue. After receipt and review of the remaining UDMH studies, EPA will complete a final assessment of dietary risk attributable to any residues remaining from past use, as well as a non-dietary risk assessment for exposure resulting from use on ornamentals.

Uniroyal voluntarily halted the sales and distribution of daminozide food-use products in June and agreed to buy back all existing stocks including those held by users. In today's action, Uniroyal offered to extend the recall and reimbursement program for existing stocks of daminozide products until November 30 for growers and December 31 for retailers. Uniroyal will notify all distributors, grower organizations and trade associations about the extended recall and reimbursement period. EPA plans to monitor the progress of the removal of daminozide from the marketplace.

EPA proposed to cancel all food uses of daminozide in May based on evidence that UDMH causes tumors in laboratory animals and that lifetime dietary exposure to this product may result in an unacceptable risk to public health. The Agency's proposed cancellation action on daminozide was based in part on a 12-month interim report of a two-year feeding study on mice using UDMH which showed that this chemical causes tumors.

In September, EPA proposed to lower the allowable residue level of daminozide in apples from the current 20 parts per million (ppm) to five ppm on November 30, 1989. On November 30, 1990, the tolerance would be lowered to one ppm and after May 31, 1991, any detectable levels would be illegal. Similar actions were proposed for the remaining food uses of daminozide. EPA proposed the tolerance-reduction action in part to insure that imported foods comply with the same residue requirements as domestic foods while daminozide is removed from the marketplace.

The cancellation order will place certain conditions on exportation of existing stocks of daminozide. Existing stocks of daminozide currently labeled for food uses may be exported under the following provisions: the stocks will be repackaged into products for non-food uses before being sold; the stocks will be shipped on pallets that are either shrink-wrapped or containerized in such a way as to maintain their integrity; and, the pallets will be clearly marked "Not registered for use in the United States of America." Section 17 of the Federal Insecticide, Fungicide and Rodenticide Act, which contains the provisions for exporting canceled pesticides, will be applicable.

Uniroyal will also be required to notify EPA at least 20 days before shipment of existing stocks and provide the name(s) of the importing country (including the specific destination within the importing country) and port of entry, the countries of final destination (if different from importing country), specific amounts of shipment, product name(s), unit size(s), date of shipment and expected date of arrival. EPA will contact the importing countries to determine whether the shipments are acceptable.

Uniroyal will also be required to follow the notification/acknowledgment provisions of section 17 before exporting any new stocks of daminozide labeled for food use, including the information that daminozide is not registered for food uses in the United States.

Daminozide is a plant-growth regulator and has been registered since 1963. In addition to apples (on which it was primarily used) and ornamentals, it was also registered for use on cherries, nectarines, peaches, pears, Concord grapes, tomato transplants and peanut vines. On fruit trees, daminozide affected flow-bud initiation, fruit-set maturity, fruit firmness and coloring, preharvest drop and market quality of fruit at harvest and during storage.