Too Toxic to Handle
Blumenthal, Dale, FDA Consumer
FDA's Phoenix resident post consumer safety officer Randall Johnson last October put FDA seals on three containers of a toxic chemical destined for hazardous waste disposal, capping an agency investigation that stemmed from a local probe of a Maricopa County health official in Phoenix.
The chemical, nicotine alkaloid, is a pesticide approved by the Environmental Protection Agency that the county's Rabies Animal Control Center was reformulating, repackaging, and using illegally as an animal tranquilizer. It has never been approved by FDA for that use.
FDA learned of the county's use of the nicotine alkaloid product during a local probe of veterinarian Thomas Kelly, then-director of the Rabies Animal Control Center. Kelly, according to a report in The Phoenix Gazette, "admitted using his workers and county vehicles to run errands for his woodworking business and conducting his private business from his county office." The newspaper also reported that Kelly's workers said they had been using the illegal nicotine product since about 1982 on Kelly's orders.
In early March 1989, FDA's Johnson visited Randy A. Baca at the Rabies Animal Control Center. Baca was acting director of the center, having replaced Kelly after allegations against the veterinarian had appeared in the local papers early in February. Baca told Johnson that one of the first steps she had taken as acting director was to instruct field personnel to stop using the chemical and return it to headquarters. Harvel Alishouse, D.V.M., air quality, advisor with the county health department, created a new warning label for the product and reissued it to the field, claiming the new labeling was considered adequate by animal control and no substitutes were immediately available.
Johnson then inspected the facility, inventoried and photographed the bulk product on hand, collected a sample of each of four dilutions of the product, and explained to Baca that the chemical is not approved for any anesthetic uses. Johnson also explained FDA's animal drug approval process and outlined the agency's good manufacturing practices and registration requirements for drug repackagers and manufacturers.
In his inspection report, Johnson noted that he "advised [Baca] that the product is too toxic to safely handle and that there is no antidote" and that "her department's use of this product contrary to its labeled indicated uses and directions for use violates Environmental Protection Agency regulations." Johnson gave Baca a source to call for information on possible substitutes.
Three weeks later, Johnson interviewed Daniel A. …