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Sec$on E Arsenic-­‐based drugs -­‐ update 2 Nachman et al. 2013 3 Chicken meat study •  Aims: –  Determine whether use of arsenic-­‐based drugs increases inorganic arsenic content in chicken meat –  Determine effect of cooking on arsenic species profile –  Characterize popula$on cancer burden •  Methods: –  Collec$on: 10 city market-­‐basket sample (conven$onal, conv abx-­‐free, USDA organic) –  Prepara$on: Half raw, half cooked (all freeze-­‐dried) –  Analy$cal: AsT: ICP-­‐MS, As species (iAs, DMA, MMA, roxarsone): HPLC-­‐ICP-­‐MS at Graz, AU –  Cancer risk assessment 4 From 2011 FDA From: Food and Drug Administra$on. 2011b. Study Title: Provide data on various arsenic species present in broilers treated with roxarsone: Comparison with untreated birds. OR Study 275.30. Laurel, Maryland. Available: h[p://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/ProductSafetyInforma$on/
UCM257547.pdf. [accessed April 20, 2012]. 5 From 2011 FDA (amended) 6 GM [iAs], by classifica0on 2.5 Package label (conven$onal, an$bio$c-­‐
free, or USDA-­‐cer$fied organic) Does the producer have a Was roxarsone detected? stated policy prohibi$ng arsenical use? 2 1.5 1 FDA "safe" limit 0.5 0 Conven$onal ABX-­‐free Organic No known policy Prohibitory Rox posi$ve Rox nega$ve policy 7 Impact of cooking on As species 8 Approach and data sources for risk assessment Table S3. Assumptions used in risk analysis
Input
Units
[iAs]
IR
BW
q*
% consuming
Inorganic arsenic concentration in cooked chicken
meat
mg kg-1
Poultry intake rate
kg day-1
Body weight
Cancer slope factor
Percent of population consuming chicken
pop size
Population size
LADD
Lifetime average daily dose
kgBW
(mg/kgBW-day)-1
%
unitless
mg/kgBW-day
Source
Our data, Table 2
EPA 2011 Exposure Factors Handbook analysis of 2003-2006
NHANES Data, Table 11-6(United States Environmental
Protection Agency 2011b)
EPA 2011 Exposure Factors Handbook analysis of 2003-2006
NHANES Data, Table 8-1(United States Environmental
Protection Agency 2011a)
EPA IRIS 2010 Draft Toxicological Assessment for Inorganic
Arsenic(United States Environmental Protection Agency 2010)
EPA 2011 Exposure Factors Handbook analysis of 2003-2006
NHANES Data, Table 11-5(United States Environmental
Protection Agency 2011b)
US Census Bureau 2011 Estimate(United States Census Bureau
2012)
Calculated (LADD = [inorganic arsenic] * IR/BW)
𝐿𝐴𝐷𝐷= ​[𝑖𝐴𝑠]×𝐼𝑅/𝐵𝑊 𝑅𝑖𝑠𝑘=𝐿𝐴𝐷𝐷×​𝑞↑∗ 𝑃𝑜𝑝𝑢𝑙𝑎𝑡𝑖𝑜𝑛 𝑏𝑢𝑟𝑑𝑒𝑛=𝑅𝑖𝑠𝑘×𝑓𝑟𝑎𝑐𝑡𝑖𝑜𝑛 𝑜𝑓 𝑝𝑜𝑝𝑢𝑙𝑎𝑡𝑖𝑜𝑛 𝑒𝑎𝑡𝑖𝑛𝑔 𝑐ℎ𝑖𝑐𝑘𝑒𝑛×𝑈𝑆 𝑝𝑜𝑝𝑢𝑙𝑎𝑡𝑖𝑜𝑛 9 Approach and data sources for risk assessment Risk analysis results: Compared to consumers of organic chicken, consumers of chicken from producers without stated policies against arsenical use have an increased risk of 3.7 * 10-­‐5. Assuming all poultry producers used arsenical drugs (and rou$ne consump$on of chicken), the increased popula$on lung and bladder cancer burden over a 70 year period is 8,661 cases, or 124 cases per year. Slide 7-­‐b Advocacy coali$ons •  Center for Food Safety (CFS) and Ins$tute for Agriculture and Trade Policy (IATP) –  2009 call for ban of all arsenicals •  FDA – no response •  CFS/IATP sue FDA in April 2013 11 Advocacy-­‐academia partnership •  New study released in May 2013 •  Complaint (lawsuit) amended to include conclusions from study •  FDA court-­‐ordered to respond to pe$$on by October 1, 2013 12 FDA response •  Nitarsone –  S$ll approved/s$ll in use 13 Conclusions •  Once in a while, we win –  Interface of science and policy •  We aren’t finished with arsenical drugs •  Is a win on roxarsone a stepping stone? 14