Animal & Veterinary
3-Nitro (Roxarsone) and Chicken
Arsenic is in the environment as a naturally occurring substance or as a contaminant and is found in water, air, soil, and food. Published scientific reports have indicated that organic arsenic, a less toxic form of arsenic and the form present in 3-Nitro® (roxarsone), an approved animal drug, could transform into inorganic arsenic. In response, scientists from the FDA’s Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition developed an analytical method capable of detecting very low levels of inorganic arsenic in edible tissue.
Using the new method, FDA scientists found that the levels of inorganic arsenic in the livers of chickens treated with 3-Nitro® were increased relative to levels in the livers of the untreated control chickens.
Alpharma, a subsidiary of Pfizer, Inc., decided to voluntarily suspend sale of 3-Nitro® and to facilitate an orderly process for suspending use of the product in the United States. Alpharma’s plan provides for continued sales of 3-Nitro® for 30 days from June 8, 2011. The company stated that allowing sales for this period will provide time for animal producers to transition to other treatment strategies and will help ensure that animal health and welfare needs are met. FDA officials stress that the levels of inorganic arsenic detected were very low and that continuing to eat chicken as 3-Nitro® is suspended from the market does not pose a health risk.
FDA: Pfizer will voluntarily suspend sale of animal drug 3-Nitro Questions and Answers Regarding 3-Nitro (Roxarsone) Transcript of FDA Media Briefing on FDA's Study Findings Leading to the Suspension of 3-Nitro (Roxarsone) Sales(PDF - 65KB)
- Audio of FDA Media Briefing on FDA's Study Findings Leading to the Suspension of 3-Nitro (Roxarsone) Sales (MP3 - 5.4MB)
Arsenic Speciation in Broiler Chickens - Summary Final Report(PDF - 342KB) Arsenic Speciation in Broiler Chickens - Amendments to Final Report(PDF - 77KB) Arsenic Speciation in Broiler Tissues - Analyst's Report(PDF - 3.1MB) Arsenic Speciation in Broiler Tissues - Statistician's Report(PDF - 406KB)