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Section D
Arsenical Drugs in Food Animal Production
Copyright © 2012 Johns Hopkins University and Keeve Nachman. Creative Commons Attribution-NonCommercial-ShareAlike License 3.0.
Overview
n 
Arsenical drugs in animal production
n 
Human exposures and risks
n 
Regulatory and legislative efforts
n 
Successes, failures and progress
3
Arsenical Drugs
n 
Roxarsone
- 
n 
n 
n 
Also p-arsanilic acid, nitarsone,
carbarsone, arsanilate sodium
Additive in poultry and swine feed since the
mid-1940s
Approved for growth promotion, improved
pigmentation, coccidiostat, treatment of
swine dysentery
In poultry production: 88 percent raised
using roxarsone
- 
- 
2010 estimate
2012 to ?
n 
In swine and turkey production: unknown
percentage
n 
Single domestic producer
4
Background and Historical Context
n 
1944: FDA new animal drug (NADA) 7-891 approval for roxarsone
n 
1951: Tolerance levels set by FDA for arsenic residues in meat
products (21 CFR §556.60)
- 
- 
2 ppm in liver
0.5 ppm in uncooked meat
n 
1981: Environmental impact analysis (for FDA)
-  “The only probable adverse effect on the human population
arising from the use of 3-nitro premixes (roxarsone) in poultry
and swine feeds is the residues of the compound which may be
present in the food of man”
n 
1983: NRC develops approach to chemical-risk assessment
5
The Roxarsone Story
Image deleted because JHSPH OpenCourseWare could
not secure permission for its use.
6
Inorganic Arsenic-Related Health Effects
n 
Arsenic is a well-characterized
human carcinogen
- 
- 
- 
n 
Noncancer health effects
- 
- 
- 
- 
Lung, bladder, skin
Other sites
Transplacental carcinogen
- 
- 
- 
- 
- 
n 
Source: CDC
Cardiovascular disease
Diabetes mellitus
Dermal effects
Neurological effects/
deficits
Immunologic effects
Fertility effects
Birth defects
Respiratory effects
Renal effects
Acute toxicity
-  Irritation of lungs, throat,
stomach, intestines, and
skin
7
Gaps in Knowledge/Remaining Questions
n 
Chicken meat
- 
n 
Arsenic type?
Environmental impact
- 
Approximately 11 tons per year, but where does it go?
8
The Roxarsone Story: 2011 and Beyond
n 
June 8: FDA announcement and Pfizer suspension also announced
- 
Press and stakeholder calls
n 
July 8: Pfizer suspends marketing of roxarsone in the US
n 
August 29: Poultry industry trade groups send letter to Margaret
Hamburg/FDA
n 
October 13: Zhejiang Rongyao Chemical Co. files a lawsuit ($20
million) against Pfizer over roxarsone
-  January 2011 contract
9
Regulatory Agencies/Mechanisms
n 
Use of roxarsone creates environmental public health issues that
extend beyond the jurisdiction of any single federal agency
- 
n 
Drugs, environmental exposures, food production, food safety,
occupational exposures
Existing regulatory mechanisms that may address some of these
issues are often inadequate
10
Regulatory Agencies/Mechanisms
n 
No existing standards addressing arsenic in animal waste
n 
No indication of further FDA action based on re-evaluation of
arsenicals
n 
So, legislative intervention?
11
Federal and State Legislative Initiatives
n 
Federal bill (introduced by Rep. Steve
Israel [D-NY])—the “Poison-free
Poultry Act”
- 
- 
HR 3264 (2009–2010)
  No vote
HR 1487 (2011–2012)
12
Federal and State Legislative Initiatives
n 
Maryland bills
- 
2010/2011
 
 
HB953/HB754 introduced by Del. Thomas Hucker
-  No vote/no decision
SB859/SB417 introduced by Sen. Paul Pinsky
- 
- 
No motion taken/no vote
2012
 
 
HB167 introduced by Del. Thomas Hucker
SB207 introduced by Sen. Paul Pinsky
13
Why Was This Year Different?
n 
The state of knowledge has changed
- 
- 
n 
FDA study
Harry Hughes Center for Agroecology’s December 2011 report
State of public knowledge and intensity of advocacy coalition/
organizing
14
2012: Success! (Sort of … )
Source: Washington Post. (2012). Copyright © 2012 Washington Post. All Rights Reserved.
15
Success?
16
Loophole?
Roxarsone
(BANNED)
Nitarsone
(EXEMPTED)
17
Next Up: New York
18
Conclusions
n 
A lack of meaningful regulatory action
n 
Maryland—a good first step, but we aren’t there
n 
Other states could follow through
n 
Eventual momentum for federal initiative
19
Wrap-Up
n 
Production of animals for food has changed drastically over the past
fifty years
n 
Current production methods pose serious risks to humans and
environmental quality
n 
Fence line communities and animal house workers bear the brunt of
these risks
20
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