johns hopkins center for a livable future.pdf

7/27/2019 Johns Hopkins Center for a Livable Future.pdf

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I dus rialF d A imalPr duc ii America:Exami i g he Impac hePew C mmissi s Pri ri yRec mme da i s

A Project o the


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IFAP in America:The CLF Report

Ce er r a Livable Fu ure C ribu rs ii

Ack wledgeme s iii

I r duc i CLF A alysis a d Assessme iv

S ruc ure a d Me h ds r his Rep r x

Public Heal h Rec mme da i s 1 1

Public Heal h Rec mme da i s 2 13

E vir me al Rec mme da i 17

A imal Wel are Rec mme da i s 25

Rural C mmu i y Rec mme da i s 31

Research Rec mme da i s 39

C clusi 45

I r duc i A erw rd 49

A erw rd 51

Re ere ces 55

Re ere ces (A erw rd) 67

Appe dix: Lis C mmissi ers 69

ContEntS


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Ce er r a Livable Fu ure C ribu rs

Bre F. KimLi ea I. Laes adiusR ber S. Lawre ce

R ber P. Mar iShaw E. McKe zieKeeve E. nachmatyler J. S. Smi hPa ricia trua


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IFAP in America:The CLF Report v

Ack wledgeme s

Te authorship team would like to thank the ollowing people and

organizations or their assistance with content and expertise:

Meghan Davis (Johns Hopkins Bloomberg School o Public Health)

Carter Dillard (Animal Legal De ense Fund)

Steve Etka (Coordinator, Midwest Dairy Coalition; Coordinator, Campaign

or Contract Agriculture Re orm)

Kevin Fain (Johns Hopkins Bloomberg School o Public Health)

arah Heinzen (Environmental Integrity Project)

Elizabeth Holmes (Center or Food Sa ety)

Patty Lovera and Michele Merkel (Food & Water Watch)

Bernard Rollin (Colorado State University)

Te Socially Responsible Agriculture Project


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vi

I r duc i CLF A alysis a d Assessme


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IFAP in America:The CLF Report vi

Each year, approximately 9.8 billion ood animals are raised and slaughtered

in the United States primarily or domestic consumption but also or the

export market. Most Americans have no idea how and where those animals

are raised. Beginning in the 1950s, the ood animal production system began

to change rom a diversi ed, extensive system with more than one species

being raised on a arm, to a specialized, intensive system with large numbers

o animals o the same species raised in con ned spaces that resemble low-rise

industrial buildings more than traditional barns.

Tis change, which has led to some economic e ciency, has also caused

serious problems in the areas o public health, the environment, and animal

wel are. In addition, this more intensive system has had unintended negative

consequences or rural communities, in many instances hindering economic

growth.

Te Pew Charitable rusts was established in 1947 to in orm public

discussion on a variety o issues, especially in the areas o public health and

the environment. According to its website, Pew applies a rigorous, analyticalapproach to improve public policy, in orm the public and stimulate civic li e.

Pew is a global research and public policy organization, still operated as

an independent, non-partisan, non-governmental organization dedicated to

serving the public1.

In the early part o the last decade, Dr. Joshua Reichert at Te Pew Charitable

rusts contacted Dr. Robert S. Lawrence, director o the Johns HopkinsCenter or a Livable Future, to discuss developing a project to study problems

associated with industrial ood animal production in the areas o public

health, the environment, animal wel are, and rural communities.

Te Pew Commission on Industrial Farm Animal Production (the

Commission) was established in 2005 by a grant rom Te Pew Charitable


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x

to compensate or the research unded by the industry to promote its business

model.

Te Commission ound signi cant in uence by the industry at every turn: in

academic research, agricultural policy development, and government regulationand en orcement. More broadly, the Commission ound that the present

system o producing ood animals in the United States is not sustainable and

presents an unacceptable level o risk to public health and damage to the

environment, as well as unnecessary harm to the animals we raise or ood2.

Te Commission released its much anticipated report on April 28, 2008,

immediately gaining the attention o state and ederal policymakers,environment and public health advocates, academics, as well as animal

agriculture producers and companies. Tere are several reasons or that.

Te Pew Commission report was the rst time the public health, environment,

animal wel are, and rural community problems caused by large scale, intensive

animal con nement operations were looked at as systemic problems and not

as separate consequences o ood animal production. It represented a thorough

compilation o the research existing at the time and compiled that in ormation

in an accessible ormat. Te diverse backgrounds o the Commission members,

their credibility and respect in the areas o interest, and the thorough

investigation o the problems strengthened the nal report.

Commissioners believed that with the involvement o Te Pew Charitable

rusts and the Johns Hopkins Bloomberg School o Public Health, two

excellent brands were supporting their e ort. Both Te Pew Charitable

rusts and Johns Hopkins are well respected among policymakers at all levels.

Pews commitment to Commission autonomy and Hopkins commitment to

providing technical support and issue expertise were essential.

Work on solving the problems caused by industrial ood animal production


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IFAP in America:The CLF Report xi

did not start with the Pew Commission report. However, it did provide new,

evidence-based in ormation organized in a compelling narrative. Following

the release o the report, Senator Edward Kennedy (DMA) initiated e orts

to legislate a ban on antibiotics important in human medicine or use in oodanimal production.

Even though unsuccess ul, that e ort led Te Pew Charitable rusts to

establish two issue campaigns to promote the adoption o some o the

Commissions work; the Human Health and Industrial Farming Campaign

and Re orming Industrial Animal Agriculture. Additionally, the Natural

Resource De ense Council, Union o Concerned Scientists, and the Keep Antibiotics Working coalition were aided in their e orts by the report.

Te work o the Commission helped generate new media attention to the

issue, including hundreds o stories using the report as an in ormation source,

including IME magazine,Preventionmagazine,Te New York imes , and

Te Washington Post . Te report remains a landmark work and is still consulted

by media, academics, and policymakers when considering ood animal

production.

Te th anniversary o the release o the Commission report presented

a logical opportunity to assess the work done to implement the original

recommendations and to determine the continued relevance o them. Te

Center or a Livable Future is best suited to conduct that assessment because it

was central to the original work and success o the Commission.

Te report that ollows is an analysis by the Johns Hopkins Center or a Livable

Future o the impact o the original Pew Commission recommendations, the

progress toward implementation o the recommendations and the barriers

encountered, and a statement o the continuing relevance o the original work.


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S ruc ure a d Me h ds r his Rep r

x


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IFAP in America:The CLF Report xii

Public Health 1. Phase Out and Ten Ban the Nontherapeutic Use o

Antimicrobials2. Improve Disease Monitoring and racking

Environment 3. Improve IFAP Regulation

Animal Wel are 4. Phase out Intensive Con nement

Rural Communities 5. Increase Competition in the Livestock Market

Research 6. Improve Research in Animal Agriculture

Tis report, Industrial Food Animal Production in America: Examining the Impact o the Pew Commissions Priority Recommendations , summarizes an assessment o the progress that has been made over the past ve yearstoward meeting these six recommendations. For eachrecommendation, in ormation on progress made as o

July 2013 was assessed by examining recent legislationand regulatory e orts at the ederal and state levels,reviewing scienti c and gray literature, and discussing the issues with researchers, advocates, and in somecases, policymakers. Tis report is not a comprehensivetreatment o all developments since the release o the 2008Commission report; instead, it aims to highlight the mostnotable e orts to date, as well as those that exempli y theoverall trends since 2008. Accordingly, several additionaldevelopments, particularly at the state level and withregard to litigation, are not ully captured here.

In some cases, legislative and regulatory actions couldbe clearly linked to recommendations presented inthe 2008 Commission report. In other instances, noexplicit connection existed, though the actions may have addressed one or more o the Commissionsrecommendations. Since the 2008 report helped shapethe overall discourse surrounding industrial ood animalproduction (IFAP) in the United States, we include theull range o actions that speak to the Commissionsrecommendations, regardless o explicit ties to the report.

Te status assessment or each o the six priority recommendations is presented separately and includes theollowing sections:

1) A brie summary o the recommendation and itsscienti c basis;( or urther in ormation on the original science underlying each recommendation please re er to the original Commission report)

2) Recent history related to the speci cRecommendation, including ederal and state governmente orts to bring about the recommended changes and

legal challenges aimed at implementation or de eat o therecommended changes.

3) Conclusion

Following these six sections, the report includes anassessment regarding the overall progress made towardre orming the ood animal production system in theUnited States.

It has been ve years since the publication o the reportPutting Meat on the

able: Industrial Farm Animal Production in America by the Pew Commission

on Industrial Farm Animal Production. A ter a rigorous process consisting o

examining technical reports rom academic institutions across the country,

listening to testimony rom stakeholders and experts, and visiting ood animal

production operations in key agricultural states, the Commission developed

24 consensus recommendations or re orming ood animal production in the

United States. Tese recommendations were intended to promote the United

States ability to provide sa e and a ordable meat, dairy, and poultry and egg

products in an environmentally and economically sustainable manner. O

these 24 recommendations, the ollowing six were designated as priority by the

Commission.


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Public Heal h Rec mme da i s 11. Phase u a d he Ba he n herapeu ic Use A imicr bials


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IFAP in America:The CLF Report 2

Summary a d basis r rec mme da i

Te practice o administering antimicrobials to ood animals or purposes other

than treatment o a diagnosed illness or control o an existing outbreak has

been commonplace in IFAP or several decades. Many o the drugs used in this

context are no di erent rom those used in human medicine. In the context

o ood animal production, the use o antimicrobials continues to increase

steadily and greatly surpasses uses in humans. Administering nontherapeutic

antimicrobials to ood animals is particularly problematic since chronic

administration o low doses o antimicrobials contributes to the evolution

and proli eration o antimicrobial-resistant strains o bacteria 3. Accordingly,

the widespread use o nontherapeutic antimicrobials in animals and the

selection o genes conveying resistance can vastly diminish the e ectiveness o antimicrobials to treat animal and human disease4.

Data on antimicrobial administration in ood animalproduction are extremely limited. Usage data areneither collected nor reported by the Food and Drug

Administration (FDA). Instead, sales data are collectedrom pharmaceutical manu acturers and released insummary orm by the FDA on an annual basis, starting in2009. o date, these sales data serve as the only surrogateor antimicrobial use in ood animal production.

Based on FDA data, 29.9 million pounds o antibiotics were sold or use in meat and poultry production in2011 5, representing 80 percent o the total volume o antibiotics sold in the United States or any purpose6.Some 685 drugs are approved by the FDA or use inanimal eed7.E ects rom these drugs, however, reachar beyond their direct administration to ood animals.Te use o animal byproducts can cause the drugs to berecycled back into ood production, urther contributing to antimicrobial pressure on bacteria present in the oodanimal production setting. A recent study, or example,has shown that eather meal, a poultry byproduct used

as a eed additive in poultry, swine, ruminant, and sheed, is a source o numerous antimicrobial (and otherpharmaceutical) residues8. All samples tested had betweentwo and ten measurable antibiotic residues. In addition,uoroquinolones, a class o antibiotics banned rom usein poultry in 2005, were ound in the majority o samplestested.

Antibiotic-resistant bacteria easily migrate rom animalproduction sites into the air, water, and soils surrounding these sites9-12. Tey can then be transported to memberso rural communities and beyond through a variety o mechanisms, including land application o animal waste

as ertilizer13. Workers at IFAP operations, ood animaltransport trucks, and nondomesticated animals (rats, birdso prey, ies) have been shown to carry antibiotic-resistantbacteria 14-19; these vectors are capable o transporting bacteria o the arm site.

Humans may be exposed to antimicrobial-resistantbacteria originating rom IFAP through a wide array o

environmental and dietary pathways, including directcontact with animals, contact with soil, air, or watercontaminated with animal waste, and consumption orhandling o contaminated ood3.

Antimicrobial-resistant in ections are o public healthsigni cance because they diminish the e cacy o medicaltreatment, resulting in increased morbidity and mortality as well as longer and costlier hospital visits20. Teadditional costs associated with antibiotic resistance havebeen studied most e ectively via comparisons betweenmethicillin-resistantStaphylococcus aureus (MRSA) andmethicillin-sensitiveStaphylococcus aureus (MSSA)21. A

study comparing hospitalization costs between patients with in ections o these types ound that even a teraccounting or the severity o the disease, the averagehospitalization cost or a MRSA patient was $45,920compared to $9,699 or a MSSA patient22. A Canadianstudy ound that MRSA in ection increased hospitalstays by a mean o 14 days23. A study o patients o theMinneapolis Veterans A airs Medical Center ound thatcompared to MSSA patients, MRSA patients were 12percent more likely to die24.

A ter considering evidence linking animal agriculturalantibiotic use practices to in ection risks in humans, the


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Commission recommended that the nontherapeutic useo antimicrobials begin to be phased out and eventually banned. As a rst step, the Commission suggested animmediate ban on any new approvals o antimicrobialsor nontherapeutic use in ood animals and calledor an FDA retroactive investigation o previously approved antimicrobials. Since the Commission issuedthis recommendation, new science has emerged thathighlights the severity o the public health threat

posed by this practice and rein orces the validity o therecommendation.

Tis section will brie y discuss key scienti c developmentsin the understanding o the public health impacts relatedto the use o antimicrobials in IFAP that have occurredsince the publication o the Commission report in 2008.

A imicr bial-Resis a Bac eriai Re ail Mea

Te National Antimicrobial Resistance Monitoring System (NARMS) tracks antimicrobial resistance inbacteria isolated rom ood animals, retail meats, andhumans. Te FDA is responsible or testing retail meatisolates, while the U.S. Department o Agriculture and theCenters or Disease Control and Prevention ocus on oodanimal and human isolates, respectively. NARMS is theprimary source o in ormation on antimicrobial resistancein oodborne pathogens available in the United States.

Te FDAs retail meat program analyzesSalmonella ,Campylobacter , Escherichia coli , and Enterococcus bacteria in collaboration with 11 state public health laboratories.Each month, participating laboratories purchase 40 meatand poultry samples, including 10 samples each o chickenbreast, ground turkey, ground bee , and pork chops. Allsamples are cultured orSalmonella while only poultry (chicken breast and ground turkey) samples are culturedor Campylobacter . Four laboratories also culture samplesor E. coli and Enterococcus . Te FDA receives all bacterialisolates or analysis, including antimicrobial susceptibility testing.

NARMS has reported concerning levels o antimicrobialresistance in bacteria isolated rom retail meat. In 2011,the most recent year reported,E. coli isolated rom 37.5

percent o chicken breast samples and 64.4 percent o ground turkey samples were resistant to at least threeantimicrobial classes. Similarly, 43.3 percent o Salmonella isolates rom chicken breast, 33.7 percent o groundturkey isolates, 42.9 percent o ground bee isolates,and 50 percent o pork chop isolates were resistant tothree or more classes. Similar results were reported orCampylobacter and Enterococcus isolates rom chickenbreast and ground turkey 25.

Another study, which reviewed 1,729E. coli isolates romhumans and ood animals collected over six decades,

ound that multidrug-resistant pathogens increased rom7.2 percent in the 1950s to 63.6 percent in the early 2000s 26.

NARMS does not monitorStaphylococcus aureus in retailmeat, though it has announced a pilot study that woulddo so. Recent literature suggests that multidrug-resistant S. aureus (MDRSA) is prevalent in U.S. meat and poultry products. Waters et al. (2011) reported thatS. aureus

contaminated 47 percent o 136 meat and poultry samplespurchased rom 26 grocery stores in ve cities; a majority o isolates (52 percent) were resistant to three or moreantimicrobial classes27. Separately, OBrien et al. (2012)reported that 64.8 percent o 395 pork samples purchasedrom 36 stores in three states were contaminated with S. aureus and that 6.6 percent were contaminated withMRSA 28.

F db r e Ill ess a do her F d-Rela ed Exp sures

Foodborne illness is responsible or signi cant morbidity and mortality in the United States, and in some cases,antimicrobial-resistant pathogens cause these illnesses. A 2013 report in Te Lancet In ectious Diseases highlightedtrends in drug-resistantSalmonella in ections around the

world and raised concerns about potentially untreatablein ections in the uture. Researchers estimated that theseserious in ections could cause an excess 1,000 deaths peryear in the United States i antibiotic treatments were tobecome ine ective 29; 30.

A Canadian study o Salmonella Heidelberg isolates rom

retail chicken meat and rom human in ections ounda strong correlation in rates o resistance to cetio ur, a cephalosporin drug that had been used in hatcheriesaround the time o the study. Te authors asserted thatcetio ur use in poultry production selects or broadspectrum cephalosporin resistance in bacteria present onchicken meat and humans31.

Beyond gastrointestinal oodborne illness, a growing body o research has associated oodborne and ood-relatedE.coli to urinary tract in ections (U Is), which are among the most common bacterial in ections globally 32. Most o the 130175 million cases per year worldwide are caused

by E. coli 33

. In the United States, the economic burdeno U Is is approximately $1.5 billion annually 34. Severeor repeated cases can cause complications including kidney damage (pyelonephritis) and blood in ections(septicemia)32.

Antimicrobial treatment, which can be o limitedsuccess in treating gastrointestinal orms o E. coli , iscritical or treating U Is and other diseases including meningitis, pneumonia, and sepsis. Over the past severaldecades, multiple classes o antibiotics used to treat


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U Is have become ine ective due to resistance. Further,contaminated ood sources have been implicated inoutbreaks o U Is (Nordstrom 2013).

Concern has also been raised over the continueduse o arsenic-based antimicrobial drugs in oodanimal production35. While evidence related to theenvironmental arsenic contribution was available at thetime o the release o the previous Commission report3,

new research has shown that the administration o arsenic-based drugs contributes to concentrations o arsenicin chicken meat36 and liver37. Residues o inorganicarsenic in edible chicken tissues increase the cancer riskso chicken consumers. While the most commonly usedarsenic-based drug (roxarsone) was voluntarily suspendedrom sale by its manu acturer in 2011, the same sponsorcontinues to sell a chemically similar product (nitarsone)that is used in turkey production38. Beyond direct dietary exposures, new research has shown that eather meal, asa eed additive or poultry, swine, ruminants, and sh,is a mechanism or cycling arsenic through the animalproduction system39.

occupa i al Exp sures

Since the publication o the Commission report, new research has demonstrated that the workplace is a site o antibiotic-resistant pathogen exposure or IFAP workers3.Much o this research has ocused around characterizationo S. aureus in swine production.

A study o nasal swabs taken rom animals and workers at 45 swine operations (21 antibiotic- ree and

24 conventional) in Illinois, Iowa, Minnesota, NorthCarolina, and Ohio used molecular characterization toexamine rates o carriage o livestock associated MRSA (LA-MRSA).Carriage o LA-MRSA was documented in

workers and pigs at conventional arms but was not oundin any nasal swabs rom antibiotic- ree operations14; 15.

A 2013 study examining workers at industrial livestock operations (with nontherapeutic antimicrobial use) andantibiotic- ree livestock operations in North Carolina ound similar carriage rates o S. aureus and MRSA among

workers o both types o operations, but only oundlivestock-associated MRSA and MDRSA in the nasal

passages o industrial livestock operation workers15

.

In addition to studies o IFAP workers, new research hasshed light on the origins o LA-MRSA. An internationalteam used whole genome sequence testing to trace thelineage o MRSA clonal complex 398 (CC398), widely recognized as an important strain o LA-MRSA, throughthe examination o the genomes o 89 CC398 isolatesrom a wide array o animal and human settings40. Using this specialized tool, the authors ound that MRSA CC398 likely originated as a methicillin-susceptibleorm o S. aureus in humans, was trans erred to swine

populations where it acquired methicillin resistance dueto antibiotic pressure rom routine antibiotic use, and wasreturned to human populations as a drug-resistant strain.

C mmu i y a dE vir me al Exp sures

Additional evidence has been generated regarding risks

to rural communities posed by antibiotic-resistantbacteria originating at ood animal production sites.A large raction o the antimicrobials ed to arm animals isexcreted unaltered (up to 75 percent) and may remain insoil ollowing land application o manure. Antimicrobialsand antimicrobial-resistant pathogens can also persistin water, as they are typically not removed completely in wastewater treatment and can be re-released to theenvironment41. Studies in China have identi ed antibioticresistance genes in water, sediment samples, and elds nextto swine eedlots41; 42.

A recently published study used electronic health recordsand data rom nutrient management plants to examinespatial relationships between animal production sites andcrop eld manure exposure and community associatedMRSA (CA-MRSA) and skin and so t tissue in ection(SS I). Te study ound associations between geographicproximity to swine manure application (spray elds) andhigh-density livestock acilities to CA-MRSA and SS I.Tis research suggests that the environmental presenceo swine manure and IFAP acilities provides a pathway to antimicrobial-resistant human in ections43. Te study also concluded that more than 10 percent o CA-MRSA

would be prevented i exposures to swine waste applied to

cropland were eliminated.A di erent study o clinically diagnosed MRSA patients ound that patients living inareas with higher livestock density were more likely tohave LA-MRSA than other types o MRSA 44.

Summary new Evide ce

Since the Commissions 2008 recommendations to phaseout and ban the nontherapeutic use o antimicrobialsin arm animals, additional scienti c evidence hasstrengthened the case that these uses pose unnecessary and unreasonable public health risks and have economic

consequences. As discussed above, antimicrobial-resistantpathogens can trans er between animals and humans;ood-related, environmental, and community exposurescontribute to the burden o antimicrobial-resistantin ections in humans. Gastrointestinal oodborne illness,MRSA, U Is, and arsenic-related disease are several o thehuman health concerns associated with nontherapeuticantimicrobial use in IFAP. Further, rom countries thathave limited or banned antimicrobial use, we have learnedthat withdrawal o antimicrobials as growth promotersresults in reduced rates o resistance in ood animal isolates29. Tis change in policy is possible without reducing rates o production when combined with more requent


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cleaning o animal housing and reduction in animalcrowding, as has been seen in the Danish swine industry;since 1994, the Danish industry has seen antibiotic useall rom more than 25 mg to 10 mg o antibiotic per kg o meat produced, all while increasing overall production by about 10 million pigs annually 45.

Rece his ry rela ed he rec mme da i

Federal Legisla ive E r s

Preservation o Antibiotics or Medical Treatment Act (1999 to present)

Te Preservation o Antibiotics or Medical reatment Act(PAM A), currently sponsored by Rep. Louise Slaughter(DNY), and its Senate companion bill, the Preventing

Antibiotic Resistance Act, currently sponsored by Sen.Dianne Feinstein (DCA), would require the FDA to

withdraw approvals o nontherapeutic uses o medically important antimicrobials in ood animals, except wherea company holding an approval demonstrates withreasonable certainty that the nontherapeutic use o thedrug will not harm human health by promoting thedevelopment o antimicrobial resistance46; 47. Tese bills

would also require a company seeking a new approval o a nontherapeutic use o a medically important antimicrobialto make the same demonstration; otherwise, approval

would be denied.

Because most approvals o nontherapeutic uses areunlikely to meet this standard, enactment o PAM A

would probably result in the withdrawal o most suchapprovals, e ectively implementing the Commissionsrecommendation with respect to nontherapeuticantimicrobial use. More than 450 public health, medical,and other organizations have endorsed the legislation48.Un ortunately, however, PAM A has ailed to passeither house o Congress in the 14 years since its initialintroduction and is not expected to pass soon.

Notably, the de nition o nontherapeutic usecontained in PAM A broadly aligns with the de nitionrecommended by the Commission. In its 2008 report, theCommission de ned nontherapeutic use as any use o antimicrobials in ood animals in the absence o microbialdisease or known [documented] microbial disease

exposure (p. 63). Tis de nition explicitly included useo an antimicrobial or growth promotion, eed e ciency,

weight gain, or routine disease prevention, all o which theCommission considered to be nontherapeutic uses.

PAM A de nes nontherapeutic use as any use o anantimicrobial except or the speci c purpose o treating an animal with a documented disease or in ection(meaning that microbial disease is present) or in ananimal that is not sick but where it can be shown that a particular disease or in ection is present, or is likely tooccur (implying that a microbial disease exposure hastranspired)46; 47. Importantly, the disease or in ection

in question cannot be present or likely to occur becauseo standard production practices or conditions. Inaccordance with the Commissions report, PAM A explicitly designates growth promotion, eed e ciency,

weight gain, and disease prevention as nontherapeuticuses.

Animal Drug User Fee Amendments o 2008

In sharp contrast to countries such as Denmark whereantimicrobial use can be traced to individual producers45,comprehensive data on antimicrobial use in U.S. oodanimals are not collected. Te only comprehensive data that exist in the United States are antimicrobial sales data reported by drug companies to the FDA under Section105 o the Animal Drug User Fee Amendments o 2008(ADUFA) 49.

Because the 2008 legislation reauthorizing ADUFA wasconsidered must-pass by both the FDA, which derivessigni cant salary support rom the user ees authorizedunder the law, and by the drug industry, which receivesswi ter review o new animal drugs as a result, the lateSen. Edward Kennedy and Sen. Sherrod Brown soughtto implement the Commissions recommendation by including PAM A in the bill. Following claims that moreresearch was necessary to support restrictions on antibioticuse, the inclusion o PAM A was scrapped in avor o the current reporting requirements. Tese requirements

were intended to collect data in support o Congressionalaction, but such action has not been orthcoming.

ADUFA directs the agency to publish annual summarieso reported data. In some cases, sales data may be used assurrogates or antimicrobial use. Un ortunately, the FDA

withholds the vast majority o data reported by companies.In the three years or which reports are available(20092011), the agency has included only domestic andexport sales by antimicrobial class50. Te sales o classesor which ewer than three companies actively market anantimicrobial are not reported separately; rather, they areaggregated into a not independently reported category.Tis ormat severely limits the utility o the summaries.

ADUFA must be reauthorized by Congress every ve years 49. Te statute directs the FDA to negotiate

recommendations or reauthorization with drug companies and to solicit public comments onthese recommendations as well. During the 2013reauthorization, a number o advocacy groups, pro essionalassociations, and academic researchers urged the agency to recommend enhancements to the antimicrobialsales reporting requirements51; 52. As in 2008, ADUFA reauthorization was considered must-pass and there ore

was seen as an opportunity to enact enhancements toreporting that the drug industry might oppose otherwise.Tese requests were to no avail, however; the FDA didnot include any enhancements in its recommendationsto Congress53; 54. Rather, the agency separately solicited


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public comment on enhancements to the annualsummaries as part o a public comment period on anadvance notice o proposed rulemaking (see below).

ADUFA was reauthorized in June 2013 without any changes to the reporting requirements o Section 105;reauthorization is next required in 201855.

Delivering Antibiotic Transparency in Animals Act (2013 to present)

Te Delivering Antibiotic ransparency in Animals(DAA) Act, sponsored by Rep. Henry Waxman (DCA), would amend the reporting requirements containedin ADUFA Section 105 to require drug companies toreport additional sales data, and to require integratorsto report data on antimicrobial use56. Te bill wouldalso direct the FDA to include additional in ormationon reported data in the annual summaries, including breakdowns by route o administration and approvedindication, animal species, and production class. Telegislation, which was introduced in February 2013 priorto reauthorization o ADUFA, has not been enacted.

Antimicrobial Data Collection Act (2013 to present)

Te Antimicrobial Data Collection Act, sponsored by Sen. Kirsten Gillibrand (DNY), would, like the DAA

Act, require the FDA to include additional in ormation onantimicrobial sales data in the annual summaries requiredunder ADUFA 57. It would not, however, require any

additional reporting o sales by drug companies or requirereporting o antimicrobial use by integrators. It has notbeen enacted.

Federal Regula ry E r s

o date, limited ederal regulatory activity has occurredsince the release o the Commission report. Te majority o activity has ocused on a series o voluntary FDA guidance documents ocused on antibiotic use.

Guidance Documents

Te FDA has pursued a voluntary and partial approachto restricting nontherapeutic antimicrobial use. In

April 2012, the agency issued one guidance documentand published a dra t o a second guidance documentthat together urge drug companies to voluntarily

withdraw approvals to market antimicrobials or certainnontherapeutic uses (i.e., growth promotion) whilemaintaining and likely adding approvals to market thesedrugs or other nontherapeutic uses (i.e., preventive orchemoprophylaxis use). (Notably, the FDA considers the

latter nontherapeutic uses to be therapeutic, though itsuse o the term is inconsistent with the Commissionsrecommendation, as explained below.)

In April 2012, FDA issuedGuidance or Industry #209:Te Judicious Use o Medically Important Antimicrobial Drugs in Food-Producing Animals , which presented tworecommendations58. First, antimicrobial use shouldbe limited to those uses that are considered necessary

or assuring animal health. Tis includes uses that areassociated with the treatment, control, or preventiono speci c diseases but does not include productionpurposes (i.e., to promote growth or improve eede ciency) (p. 21). Second, antimicrobial use should belimited to those uses that include veterinary oversight orconsultation (p. 22).

When the FDA issued Guidance 209 in April 2012,it simultaneously published a dra t o Guidance or Industry #213: New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water o Food-Producing Animals:Recommendations or Drug Sponsors or Voluntarily Aligning Product Use Conditions with GFI #209 59. Guidance 213 isintended to implement the recommendations containedin Guidance 209 by requesting that drug companiesvoluntarily withdraw approvals to market antimicrobialsor use in animal eed and drinking water or productionpurposes such as growth promotion and eed e ciency. Italso requests that companies voluntarily amend approvalsto market antimicrobials over the counter so that a veterinary prescription or veterinary eed directive (seenext section) is required to purchase and use these drugsin eed and water. Guidance 213 requests that companiescomplete voluntary withdrawals and amendments withinthree years o the nalization o Guidance 213, which isexpected soon.

Te voluntary guidance documents are inconsistent withthe Commissions recommendation that nontherapeuticuse o antimicrobials in ood animals be phased out andeventually banned. Most importantly, while the FDA hasrecommended that production uses be discontinued,it has endorsed the continued use o antimicrobialsor routine disease prevention, which the Commissionexplicitly mentioned as an example o nontherapeutic use.Notably, Guidance 213 provides or the replacement o

production approvals with disease prevention approvals,something that the drug industry has said it will pursue.In many cases, the doses and durations o antimicrobialuse or disease prevention are similar or even identical tothe doses and durations utilized or production purposes.Tis means that while antimicrobial approvals may changeunder Guidance 209 and Guidance 213, antimicrobial usemay not.

Te voluntary approach has come under withering criticism rom the public health, medical, and othercommunities concerned about the increase in antibiotic-resistant bacterial pathogens. Many have highlighted the


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loophole that could allow disease prevention approvalsto replace production approvals without altering actualuse or selection or antimicrobial resistance60; 61. Somehave also criticized the reliance on a voluntary approachin place o regulation (i.e., withdrawal proceedings)62; 63.Tese problems are interrelated: Voluntary action by drug companies depends on the companies ability to replace

withdrawn production approvals with new preventionapprovals and thereby maintain current sales and use64.

Veterinary Feed Directive Regulation

A veterinary eed directive (VFD) is essentially a veterinary prescription or a drug administered in eed.Guidance 213 requests that drug companies voluntarily amend current approvals to market in- eed antimicrobialsover the counter so that a VFD is required or their use.Simultaneously, the agency is amending the requirementsor issuing a VFD, ostensibly to streamline the processand encourage the transition rom over-the-counter(O C) to VFD status under the guidance document 65.Te FDA published a dra t proposed rule in April 2012and received comments on it. Te agency will next publisha proposed rule and receive additional comments. Finally,the proposed rule will be nalized with any changes madeby the FDA.

Te Commission recommended increasing veterinary oversight o all antimicrobial use in ood animalproduction. Un ortunately, while Guidance 213 may result in transitioning antimicrobials used in medicatedeed rom O C to VFD status, thereby increasing veterinary oversight, changes to the VFD requirementscould weaken signi cantly the meaning and value o such oversight. Most importantly, the dra t proposed ruleremoves the requirement that a VFD only be issued in thecontext o a valid veterinarian-client-patient relationship(VCPR) 65. A VCPR exists when the veterinarian,among other things, has recently seen and is personally acquainted with the keeping and care o animals. Teremoval o the VCPR requirement may allow veterinarians(such as those employed by large integrators) to issue a VFD to an operation without having visited the operationrecently and without having examined the animals.

Cephalosporins

In April 2012, the FDA banned certain extra-label uses o cephalosporins66. (An extra-label use is an unapproved useo a drug approved or other conditions.) Te ban ollowedthe publication o studies nding that certain extra-labelcephalosporin uses, especially the prophylactic injectiono chicken eggs at hatcheries, promoted cephalosporinresistance inSalmonella . Cephalosporin resistance inthese bacteria is concerning because cephalosporinsare the drugs o choice or treating salmonellosis inpediatric settings; the drugs o choice in adult patients,uoroquinolones, cause severe side e ects in children. Te

2012 extra-label use ban came a ter the FDA withdrew a more comprehensive ban proposed in 2008 ollowing opposition rom industry 67.

Advance Notice o Proposed Rulemaking

In August 2012, the FDA issued an advance noticeo proposed rulemaking (ANPR) and solicited public

comments on multiple issues related to data onantimicrobial sales and use. Te agency stated that itintended to consider these comments as it identi edapproaches to collecting additional data 68. During

ADUFA reauthorization, when public health advocatesurged the agency to recommend enhancements tothe reporting requirements enacted under ADUFA in2008, the agency claimed that it would pursue any suchenhancements separately ollowing consideration o comments on the ANPR. Tis engendered skepticismamong public health stakeholders, as the ANPR appeareto be merely a means to de ect criticism o agency inaction antimicrobial resistance during the reauthorizationprocess.

S a e Legisla ive E r s

Legislation that would ban the nontherapeutic use o antimicrobials in ood animals or require the labeling omeat and poultry produced with these drugs has beenintroduced in multiple states, including Cali ornia,Minnesota, Maryland, New York, and Pennsylvania.None o the bills has passed. In addition to oppositionrom the drug and ood animal industries, oppositionrom state agencies has been reported. Ban and labelingbills, or example, that were introduced in Marylandin 2013 were opposed by the Maryland Department o

Agriculture69.

Maryland Arsenical Antimicrobial Drug Ban

On January 1, 2013, Maryland became the rst state toprohibit the use o roxarsone and most other antimicrobiarsenical drugs in chicken eed70. Nitarsone, an arsenic-based drug approved or use in chicken and turkey production, was exempted rom the ban.Several other

states are now considering similar legislation, includingNew York 71 and Vermont 72.

S a e Regula ry E r s

We could not nd evidence o state regulatory measures control antimicrobial use in ood animal production.


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Li iga i

Natural Resources De ense Council v.Food and Drug Administration

In May 2011, the Natural Resources De ense Council(NRDC) and others sued the FDA, alleging that theagency was obligated to withdraw approvals to marketpenicillin and tetracyclines or nontherapeutic purposes

ollowing a 1977 nding that these approvals were notshown to be sa e73. Te plainti s urther alleged thatthe FDAs ailure to respond to two citizens petitions orthe withdrawal o nontherapeutic approvals that weresubmitted in 1999 and 2005 was unlaw ul. Although the180-day deadline or agency responses to such petitionsseldom is met, the 12 and six years that these petitionershad waited exceeded typical delays.

Te FDA responded by attempting to avert both claims,rst by denying (and thereby responding to) both petitionsin November 2011 and then by withdrawing the 1977ndings during the ollowing month 74-76. In both cases,the agency claimed that withdrawal proceedings wouldbe too costly and take too long while reiterating that itintended to address certain nontherapeutic approvalsas described in the voluntary guidance documents(see above). Te plainti s amended their complaint tochallenge the denials o the petitions as arbitrary andcapricious because they did not address either petition onits merits, ocusing instead on agency resources.

In March 2012, a U.S. magistrate judge ruled thatthe FDAs ailure to pursue withdrawals o penicillinand tetracycline approvals ollowing the 1977 ndingsconstituted an agency action unlaw ully withheld andordered the agency to reissue its ndings and initiate

withdrawal proceedings63; 77. In June 2012, the same judgeruled that the denials o the petitions were arbitrary andcapricious and remanded them to the agency or review ontheir merits62; 78. Te FDA has appealed both decisions;brie ng and oral arguments in the appeal concluded inFebruary 2013. A decision is expected soon.

Government Accountability Project v.Food and Drug Administration

As mentioned above, there have been a number o unsuccess ul e orts to access additional antimicrobial salesdata that the FDA collects under ADUFA but does notshare with the public. E orts to amend ADUFA during the 2013 congressional reauthorization were unsuccess ul.Meanwhile, the agency has announced that it willre ormat annual summaries o these data starting this year,but these remain subject to a number o constraints.

In early 2011, the Johns Hopkins Center or a LivableFuture (CLF) approached the Government Accountability Project (GAP) or assistance in obtaining additionalsales data. GAP submitted a Freedom o In ormation

Act (FOIA) request to the FDA 79. Te agency deniedthe request, claiming that the requested data werecon dential commercial in ormation and there oreexempt rom disclosure under FOIA (the statutecontains a number o such exemptions). GAP appealedadministratively to the Public Health Service (PHS),a division o the Department o Health and HumanServices that includes the FDA. Te PHS denied theappeal in September 2012, likewise holding that the data

were con dential commercial in ormation.

In December 2012, GAP led a complaint in U.S.district court, alleging that the FDA had inappropriately denied the request or additional data 79. In the FDAsmotion or summary judgment, submitted in July 2013,the agency relied on a davits rom 13 drug companiesthat oppose the release o additional sales data. It is likely that companies opposition to the release o sales data isbased on a desire to avoid heightened scrutiny o theirproducts. Brie ng on summary judgment will conclude inSeptember 2013, with a decision to ollow.

Lawsuits Relating to Arsenical Use

In 2013, two lawsuits were led relating to the FDAscontinued approval or the use o arsenic-basedantimicrobial drugs in animal eed. A ter petitioning theFDA in 2009 to withdraw approvals or arsenic-baseddrugs in ood animal production, the Center or FoodSa ety, the Institute or Agricultural and rade Policy (IA P), and seven other groups led suit in 2013 or notresponding to their petition80.In a separate suit, Foodand Water Watch brought charges against the FDA or

ailing to respond to a Johns Hopkins Center or a LivableFuture FOIA request or communications made betweenthe agency and the P zer pharmaceutical company (which manu actures the arsenic-based drugs roxarsoneand nitarsone) with regard to arsenical drugs81. As o September 2013, both lawsuits were pending.

V lu ary I dus ry E r s

Suspension o Roxarsone by Pfzer

In June 2011, the FDA announced that P zer was

voluntarily suspending domestic sales o the arsenic-baseddrug roxarsone. Tis action was taken a ter the FDA advised P zer o a new agency-conducted study that oundthat levels o inorganic arsenic in the livers o roxarsone-treated chickens compared to those in untreated chickens82. Despite the ndings o its study, the FDA did notormally withdraw the approvals or roxarsone or otherarsenic-based drugs.Consequently, P zer may reintroducethe drug into the market at will. Further, Zoetis ( ormerly P zer Animal Health) currently markets nitarsonedomestically and continues to sell roxarsone outside theUnited States36.


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C clusi sEvidence linking antibiotic misuse in IFAP toenvironmental transport o and human in ection withantibiotic-resistant bacteria continues to accumulate.Despite the sizable body o literature supportive o a decision to eliminate antimicrobial use outside the contexto veterinarian-diagnosed disease, little progress has beenmade to change patterns o use. While some meagersuccess has been achieved (in the orm o the ban o

o -label uses o cephalosporins), the voluntary approachpre erred by the FDA and the lack o willingness by theindustry to alter its behavior suggest that meaning ulchange is unlikely in the near uture. Similarly, in thecase o arsenic-based drugs, the evidence linking use o these compounds to dietary and environmental arsenicexposures has become ar stronger. Even with new evidence, the FDA has not taken action to remove thesedrugs rom the domestic market.


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Citing the importance o an accurate trace-back system in the event o a

zoonotic disease outbreak, the Commission recommended that a disease

monitoring program, accompanied by an animal-speci c tracking system, be

put in place to allow or a 48-hour trackback o ood animals at every stage o

production. It identi ed an existing voluntary system or animal tracking put

in place by the USDA Animal Plant and Health Inspection Service (APHIS),

but proposed that a plan or a mandatory animal- or lot-based tracking

system be established by 2009, with implementation scheduled or 2010. Te

Commission also recommended ederal regulatory oversight o such a tracking

system, along with nancial assistance or smaller producers in pursuit o

compliance.Rece His ry Rela ed he Rec mme da i


Meat Sa ety and Accountabil ity Act o 2010

In 2010, Sen. John ester (DM ) introduced theMeat Sa ety and Accountability Act83, which calls orcontaminated meat products to be traced back to theoriginal source o contamination, including preparation,

processing, and slaughtering acilities, as well as or testing practices at meat suppliers and processors to be improved. While the bill had support among ood sa ety advocates84,the legislation died in committee.

Food Sa ety Modernization Act o 2011

President Obama signed the Food Sa ety Modernization Act (FSMA) into law in 2011, instructing FDA to deviseregulatory approaches to ensure the sa ety o the nationsood supply rom arm to ork. While the sa ety o themajority o animal products (aside rom sea ood) is outside

FDAs jurisdiction, the agency is responsible or producesa ety. Given the requency with which animal waste isused as ertilizer in the production o ruits and vegetables,concerns exist regarding the potential transport o pathogens present in animal waste13 to crops intended orhuman consumption. Among the mandates placed uponFDA in FSMA are those related to enhanced tracking and traceability o ood, along with calls or improvedrecord keeping 85. In response to this mandate, FDA initiated pilot projects to aid it in assessing best practicesor product tracing, and published a document describing

lessons learned in March 201386. A ter soliciting eedback on this document, the agency will initiate rule making onhigh-risk oods to acilitate product tracing 87.


National Animal Identi fcation System (NAIS)

When the Commission report was released, the USDAs

APHIS was attempting to implement the voluntary National Animal Identi cation System (NAIS). Tise ort relied on producers registering their premises andidenti ying their animals in a national animal-tracking database, with the goal o being able to quickly identi y outbreaks o in ectious disease in livestock. In responseto continued low NAIS enrollment in 2009, APHIS helda series o listening sessions on animal identi cation toclari y any issues or concerns with the program88. A tera large number o producers voiced signi cant concerns

with NAIS, the program was never ully implementedand was ultimately discontinued in 201289. Particularconcerns arose with regard to privacy, a lack o exibility,

and excessive costs or smaller producers.

Animal Disea se Traceabili ty Final Rule

Following the discontinuation o NAIS, APHIS has worked to develop a new approach to tracing animals. In January 2013, the USDA issued a nal rule on animaldisease traceability 90. Tis revised strategy addresses many o the concerns associated with NAIS, and also re ectsboth eedback rom public meetings held on the issue in2010 and comments made on an initial rule proposed in

August 2011 89. In a signi cant departure rom NAIS, the


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new rule applies only to animals moving interstate, andtracing data will be maintained by states rather than in a centralized database. Additionally, the proposed provisionsare no longer voluntary, requiring instead that speci edlivestock species that are moved interstate be o cially identi ed and accompanied by an interstate certi cate o veterinary inspection or other documentation agreed uponby shipping and receiving states. APHIS notes that therule is not ocused on ood sa ety and that animal disease

traceability ends when an animal is slaughtered. Te nalrule became e ective March 11, 2013.

Changes to FSIS Food Sa ety Tracing o Meat Products

Te USDAs Food Sa ety and Inspection Service (FSIS), which regulates meat, poultry, and egg products (eggsthat have been removed rom shells), has undertakennumerous e orts since 2008 to improve procedures ortracing contaminated meat. In March 2010, FSIS held a public meeting to discuss its e orts to improve tracebacksor products contaminated withE. coli . In response tocomments rom this meeting, FSIS revised its inspectionprocedures in 2012 so that personnel gather supplierin ormation each time they sample ground bee or benchtrim (the at or meat removed at the processing plant)or E. coli , rather than waiting until they have a positivetest result to gather supplier in ormation91. Tis changeallows FSIS to identi y suppliers more rapidly in the caseo positive test results. In the same year, FSIS urtherexpedited its process by beginning tracebacks to identi y suppliers and processors based on presumptive positive testresults orE. coli instead o waiting or con rmed positive

results92

.

Additionally, FSIS issued three nal rules in response to2008 Farm Bill provisions. Speci cally, the new rulesrequire establishments to 1) prepare and maintain recallprocedures, 2) noti y FSIS within 24 hours that a meator poultry product that could harm consumers has beenshipped into commerce, and 3) document reassessments o their hazard control and critical control point system oodsa ety plans92.


Texas Animal ID Law

At the state level, a 2013 animal identi cation law in exashas been drawing many o the same criticisms that werevoiced about the National Animal Identi cation System.Te legislation, which was signed into law in May 2013,allows (but does not require) the exas Animal HealthCommission ( AHC) to develop and implement a stateanimal identi cation system that is no more stringentthan a ederal animal identi cation program93. Inthe event that a two-thirds vote by the AHC can beachieved, the law permits the commission to have a more

stringent program only or control o a speci c animaldisease or or emergency animal management. Advocatesand groups representing small-scale armers haveindicated signi cant concern that the legislation would beprohibitively cumbersome and expensive or small armersand individuals raising backyard chickens93.


We could not nd evidence o state regulatory measures toimplement animal disease monitoring or tracking.


We could not nd evidence o industry measures toimplement animal disease monitoring or tracking.

C clusi a d Pr gress Da eLimited meaning ul activity has occurred in the domaino zoonotic disease monitoring and tracking since theCommission issued its recommendations in 2008. Whilea ew ederal initiatives that held promise were initially promoted, pushback rom the agricultural industry hasresulted in the dropping or signi cant weakening o these approaches. Consequently, it is not expected thatmeasurable changes in rates o oodborne illness resulting rom contaminated animal products will be observed.Upcoming regulations addressing produce sa ety underFSMA may, however, result in process controls and checksthat can limit the requency or reduce the impact o in ectious disease outbreaks stemming rom contaminatedproduce. Te true impact o these regulations remains tobe seen, as dra t regulations addressing traceability haveyet to be released.


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E vir me al Rec mme da i3. Impr ve IFAP Regula i


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As the number o animals on arms has grown and animal production acilities

have become increasingly concentrated geographically, signi cant problems

related to the storage and disposal o manure have been documented13; 35. Te

USDA estimates that more than 335 million dry tons o manure are produced

yearly in the United States94. Nutrients rom excessive manure application

(and dumping) can enter ground and sur ace waters, leading to signi cant

environmental and public health concerns. IFAP acilities can also contaminate

water supplies with chemicals present in pesticides95, antibiotics96, hormones97, and heavy metals35, as well as pathogens10 and antibiotic resistance genes96.

Food animal production sites and waste storage acilities have also been shown

to be responsible or releases o air pollutants, including ammonia 98, hydrogensul de 99, pathogens11, endotoxins100, and animal dander101.

In light o the air and water pollution stemming romIFAP acilities (and the corresponding potential or humanexposure), the Commission recommended that IFAP beregulated in a manner similar to that o other industrialoperations. o accomplish this, the Commission notedthat the current patchwork o laws and regulations dealing

with arm waste should be replaced with new laws andregulations outlining baseline waste-handling standardsor these acilities. Tese standards should speci y theregulations that states must put into place to preventpollution rom IFAP acilities.

Rece His ry Rela ed he Rec mme da i


Proposed Amendments to Block FOIA Requests o Farmer Data

In 2013, Sen. Chuck Grassley (RIA) proposedamendments to limit the EPAs ability to respond toFOIA requests about livestock producers102; 103. Teprovisions would prevent the disclosure o even the mostbasic in ormation about producers or the location o their acilities. Sen. Grassley introduced these measuresin response to the EPAs controversial release o personalin ormation (including names, contact in ormation, andgeographic locations) on livestock producers to advocacy groups in February 2013104. Grassley initially discussedo ering the EPA amendment during the Farm Bill debatebut ultimately decided against doing so. Instead, heintroduced a stand-alone bill in July 2013104.

Farm Dust Regulation Prevention Act o 2011

In 2011 Rep. Kristi Noem (RSD) introduced Te FarmDust Regulation Prevention Act, which would haveexempted particulate matter generated by agriculturalactivities rom regulation under the Clean Air Act. I

passed, the bill would have prevented the EPA romissuing any new rules regulating coarse particulate matteror a one-year period. Te introduction o the bill wasmet with criticism rom the public health community 105. While this e ort was passed by the U.S. House o Representatives, it did not pass the Senate and there oredid not become law. Te e ort was signi cant, however,because it exempli ed the push or legislation thatpreempts agricultural re orms. Tis e ort was also notablebecause the EPA had not made any attempt to regulatearm dust.


Changes to Regulations on National Pollutant Discharge Elimination System Permits

On October 31, 2008, the EPA issued a nal rule onefuent discharges and nutrient management o CAFOs.Tese new regulations were revised rom original 2003rules a ter the 2005Waterkeeper Alliance et al. v. EPA decision. Te nal ruling on this case in the U.S. Courto Appeals or the Second Circuit included two majorchanges to the 2003 rules. First, the regulations requiredonly CAFOs that discharge or intend to discharge waste


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to apply or National Pollutant Discharge EliminationSystem (NPDES) permits. Be ore the decision, the rulehad required all CAFOs to apply or permits. Second,the new rules required CAFOs to submit NutrientManagement Plans (NMPs) along with their NPDESpermit applications.

Soon a ter the establishment o these regulations, theNational Pork Producers Council, along with nine

other groups representing pork, chicken, dairy, andegg industries, appealed to the U. S. Court o Appealsregarding the CAFO regulations. InNational Pork Producers Council v. EPA, the court ruled on March 15,2011, that only CAFOs that actually discharge into watersmust apply or NPDES permits, thereby omitting CAFOsthat intend to discharge into waters rom regulation106. In July 2012, a new nal rule excluding the vacatedprovisions requirements or CAFOs that intend todischarge into waters was issued.

EPA Withdrawal o Proposed CAFO Reporting Rule

As a part o a 2010 settlement with the Waterkeeper Alliance, Natural Resources De ense Council, and Sierra Club, in 2011 the EPA proposed a new rule seeking toobtain basic operational in ormation rom CAFOs toassist with the en orcement o EPA water quality standardsunder the Clean Water Act107. A ter the public commentperiod, however, the EPA withdrew the proposed CAFOdata collection rule in 2012. As there is no requirementor CAFOs to submit this in ormation to the EPA undercurrent regulations, the agency noted that it plans to rely

on existing sources to obtain this in ormation106

.

In response to this action, the Natural Resources De enseCouncil, Earthjustice, and the Pew Charitable rustsled Freedom o In ormation Act (FOIA) requests orurther in ormation on the withdrawal o the reporting rule and EPAs currently available in ormation on CAFOsand their locations108; 109. Te EPA initially approved thisrequest and released the in ormation in February 2013;however, this decision was met with substantial backlashby industry and Congress110-112. Te EPA subsequently requested that the organizations return the CAFOdata, and it distributed new data sets with the personal

in ormation o armers redacted108

.

CERCLA/EPCRA Reporting Exemption or Air Releases o Hazardous Substances rom Animal Waste at Farms

In a development counter to the Commissionsrecommendation that IFAP be regulated in a mannersimilar to that o other industrial operations, a new EPA rule exempting IFAP acilities rom air pollutant reporting requirements under two key ederal statutes came intoe ect in January 2009. Te two statutes in question, the

Comprehensive Environmental Response, Compensation,and Liability Act (CERCLA) and Emergency Planning and Community Right to Know Act (EPCRA), areintended to ensure that ederal, state, and local authoritiesare noti ed about releases o substances dangerous tohuman health and the environment.

Under this new rule: 1)all arms (including AFOs) thatrelease hazardous substances rom animal waste to the air

are inde nitely exempt rom reporting under CERCLA provisions; and 2) arms under a certain size that releasehazardous substances rom animal waste to the air areexempt rom reporting under EPCRA provisions113. Inaddition, as part o an agreement with AFOs that signeda consent agreement in 2005 to und the National AirEmissions Monitoring Study (NAEMS), the EPA hassaid it would not sue or civil violations o EPCRA andCERCLA reporting requirements. Tese operations (morethan 13,000 AFOs) are thus not expected to make reportsat this time 113. In justi ying its decision, the EPA notedthat it could not oresee a situation where the Agency

would initiate a response action as a result o [a CERCLA]noti cation 114. Both environmental and industry groupschallenged this rule in 2009, but an updated rule hasnot yet been proposed. In 2011, industry advocates alsoattempted, unsuccess ully, to permanently exempt manurerom CERCLA through the Super und Common Sense

Act.

National Air Emissions Monitoring Study (NAEMS)

In 2005, the National Air Emissions Monitoring Study

was established through an Air Quality Compliance Agreement with animal producers. In return or paying a civil penalty, as well as unding and participating inthe study, the EPA agreed not to sue participants orcertain past and study-period violations o the Clean

Air Act, CERCLA, and EPCRA 115. Participants o theCompliance Agreement are currently not expected tomake reports under EPCRA 114. Te study was intendedto provide the EPA with data needed to develop a procedure or estimating emissions rom IFAP acilities.Tese methodologies are in turn intended to help theEPA determine the air compliance status o acilities116. Participating acilities are obligated to use the

methodology developed and apply or a permit under theClean Air Act i they exceed emissions thresholds116.

NAEMS was conducted as an EPA/industry partnership.In addition to the unding rom speci c operations,industry trade organizationsthe National Pork Board,the National Chicken Council, the National Milk Producers Federation, and the American Egg Boardalsoprovided unding. Purdue University led the study, withassistance rom other land grant universities117. Te study has been characterized as having a con ict o interest,


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given the industry unding o the study and the soleinvolvement o agriculture schools without inclusion o public health schools118.

While NAEMS was initiated prior to the Commissionreport, the EPA made the data rom the study availablein 2011. Te rst dra t o methodologies or estimating emissions rom broiler operations, and manure lagoonsand basins at swine and dairy operations, was released or

public comment in 2012119.

Since the dra t data release, the data generated underNAEMS have been subjected to considerable criticism.Te Environmental Integrity Project (EIP), an advocacy organization, released a report highlighting instances

where the NAEMS data clearly identi y short-terminstances o exceeding EPA standards or ne and coarseparticulate matter, ammonia and hydrogen sul de, despiteserious limitations associated with the methods under

which the data were generated and reported. In theirreport, EIP noted numerous problems with the NAEMSdata, ranging rom the limited number o acilitiesmonitored, to the problematic placement o monitoring equipment within sites, to the inclusion o negativevalues or pollutant concentrations in calculated averageconcentrations or site contaminants120.

EPAs Science Advisory Board has also voiced concernsabout the quality o the data and has recommendedthat the EPA not apply the current versions o thestatistical and modeling tools or estimating emissionsbeyond the arms in EPAs data set121. Accordingly,there is a possibility that the EPA may not nalize themethodologies. Further, there is an indication that

the EPA is holding o on issuing a new rule on theCERCLA/EPCRA exemptions until nal emissionsestimating methodologies have been developed (personalcommunication, . Heinzen).

Chesapeake Bay Total Maximum Daily Load

In December 2010, the EPA established the ChesapeakeBay otal Maximum Daily Load ( MDL) pollutiondiet designed to identi y the maximum amount o pollution a body o water can receive and still meet state

water quality standards122. Te Chesapeake Bay MDL is

the largest such e ort to date and was established becauseo ongoing problems with water quality despite restorationprojects. Tis e ort is required under the Clean Water Actand is described by EPA as an integral part o meeting a 2009 Executive Order seeking to restore and protect theChesapeake Bay watershed122.

Te MDL consists o a set o pollution controls tomeet water quality standards in the Bay and tidal rivers.Te MDL calls or sizable reductions in pollutantsincluding a 25 percent reduction in nitrogen, a 24 percentreduction in phosphorus, and a 20 percent reduction insediment. Accordingly, IFAP acilities and runo rom

agricultural lands are key targets or limiting pollutantsin the watershed. Te EPA aims to complete all necessary pollution control methods by 2025, with 60 percent o theactions completed by 2017122. Should the ChesapeakeBay watershed states and the District o Columbia ail tomeet their Watershed Implementation Plans outlining how and when they will meet their pollution allocations,the EPA has stated that it is committed to taking stepsincluding compliance and en orcement actions, expanding

requirements to obtain NPDES permits or currently unregulated sources and placing additional controlson pollution sources such as large animal agricultureoperations122.

Te EPA has also stated that it supports the decision o states to use nutrient trading to help meet their MDLobligations123. Currently, Maryland, Pennsylvania,Virginia, and West Virginia have all implemented nutrienttrading programs124. Some members o the public healthcommunity have recently spoken out against waterpollution trading, citing concerns over environmentalinjustices arising rom trading schemes and shortcomingslikely to arise rom minimized transparency and oversighto trades 125. In response to the growing emphasis on thismarket-based, rather than regulatory, strategy or reducing emissions, advocacy organizations Food and Water Watchand Friends o the Earth led suit against the EPA to endapproval or nutrient trading under the MDL 126. As o

August 2013, the case is pending.


A number o legislative e orts have been made at the state

level and aiming at the abilities o states to regulate IFAPsites. Many o these proposed bills were intended to limitor scale back regulatory oversight. In Arizona, legislation

was passed that stripped counties o their zoning authority to regulate dairies127. In 2013, Iowa passed legislation

weakening the regulation o production site manuremanagement, allowing the reclassi cation o arm size(and ultimately, the accompanying regulatory oversight/ee structure) on the basis o number o animals presentonsite, rather than actual carrying capacity 128. In thesame year, Iowa also passed legislation to limit publicnotice requirements or water permits to a notice in a single publication128. Michigan enacted legislation in

2011 that excused animal eeding operations rom nes orpenalties under the Clean Water Act i they participatedin the states voluntary Agricultural Environmental

Assurance Program129. In the same year, Missouripassed a law that put limits on the amount o money awarded in nuisance suits and prohibited repeat ling o nuisance claims regarding the same issues rom a singlearm 130. Ohio passed legislation in 2008 to requestrom EPA permission to trans er authority over its Clean

Water Act program rom its environment department toits agriculture department; EPA has since approved the


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trans er 131. Te same trans er was made by the state o Oregon in 2012, and the legality o that trans er has beenquestioned by legal researchers132.

A small number o state legislative actions appearedto be steps toward more meaning ul regulation o animal production sites. In 2009, the Washington StateLegislature passed its rst law subjecting dairy CAFOsto penalties or ailure to comply with recordkeeping

requirements or manure management133. Te IllinoisLegislature passed a law in 2012 requiring CAFOs to pay ees or NPDES permits 134.

Te state o Indiana passed two pieces o legislation thatled to mixed impact on regulatory oversight o animalproduction operations. Te rst required certi cationo poultry waste applications (whereas no system hadpreviously existed). In the same bill, local communities

were orced to cede control over manure regulationsthrough ordinances to the state135; 136. Indiana also revisedits Con ned Feeding Operations regulations136, butemployed setbacks that were criticized by advocacy groups.


A number o regulatory policies have been put in placesince the release o the Commission report that show signs o promise in regulatory oversight o IFAP sites.In response to a petition rom the Illinois Citizens orClean Air & Water advocacy group, the EPA investigatedIllinois en orcement o the Clean Water Act. In 2010,the agency ound merit to the claims that the state wasnot properly regulating CAFOs, and mandated thatit take measures to strengthen its NPDES programand pursue the permitting process137. New Mexico setdischarge permit regulations or industrial dairies in 2011,including requirements o synthetic liners or dairy wastelagoons and enhancement to public notice provisionsor construction o new dairies138. Oregon raised waterquality permitting ees or CAFOs in 2011139.

Cali ornia is the only state to promulgate regulationthat negatively impacted IFAP oversight; it weakenedits coverage o operations required to apply or NPDESpermits, limiting it only to those already shown todischarge140.

Agr icultural Certainty Programs

A number o states, including Virginia 141, Minnesota 142,and Maryland143, have now adopted agricultural certainty programs (either through legislation or through currentstate agency authority). Te EPA has also o ered itssupport or states adopting these programs144. While theprovisions o the programs vary by state, the underlying premise is that armers take voluntary actions that exceedcurrently mandated practices in return or assurance thatthey are in compliance with regulations or the duration

o their agreement. Tus, armers become exempt romany new state requirements that are implemented during that time period. Virginias recently enacted program,or example, states that participating armers would beexempt rom any new environmental regulations related tothe Chesapeake Bay or local MDLs or total maximumdaily loads or nine years141. While these programs serveas an incentive or armers to improve their practices inthe short term, exempting armers rom new regulations

has also raised concerns among many environmentaladvocates145.

Li iga i

Issues related to the regulation o IFAP operations havebeen the subject o a considerable volume o litigation.Highlights rom this extensive legal activity are presentedhere.

Michigan Court Rul ing on CAFO Permits

While NPDES permits are now only required orCAFOs that discharge, in 2011 the Michigan Court o

Appeals upheld the states right to also require permitsor CAFOs that propose to discharge146. Te ruling wasbased primarily on the act that the Michigan Departmento Environmental Quality (DEQ) administers NPDESpermits in the state rather than the EPA, and that theClean Water Act allows states to implement more stringentrequirements than the EPA. Further, the court oundthat Michigans Natural Resources and EnvironmentalProtection Act gives the DEQ authority to orestallpotential pollution even be ore any discharge o pollutantsever occurs147. As o May 2013, all CAFOs in Michiganhad to obtain either NPDES permits or No Potential toDischarge Determinations148.

Move to Use RCR A in Place o CWA

While most previous legal interventions to address poorpractices at individual IFAP acilities have been broughtunder the Clean Water Act, advocates are now alsobringing charges under the Resource Conservation andRecovery Act (RCRA) because o the limitations o the

CWA. When used as ertilizer, manure does not quali y as solid waste under RCRA 149. When manure is allowedto discharge into ground water, however, advocateshave argued it represents a solid waste regulated underRCRA 150. In April 2013, the Center or Food Sa ety,CARE, and Public Justice led suit under RCRA againstour dairies in Yakima Valley, Washington151.


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A imal Wel are Rec mme da i s4. Phase ou I e sive C f eme


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Over the past ve decades, animal production in the United States has shi ted

away rom an extensive pasture-based system toward the intensive con nement

o large numbers o animals o the same species. While this shi t has enabled

increased production and some economies o scale, it has also resulted in

substantially poorer living conditions or animals raised or ood. Practices such

as con ning animals in spaces too small to allow or natural behaviors, altering

animals without pain relie , and providing animal eeds that promote growth at

the expense o animal health have become routine. Further, there are currently

no ederal regulations in place to protect arm animal wel are.

In light o these conditions or animals, and theconnections between animal wel are, ood sa ety, andthe public, the Commission recommended that allintensive con nement systems that restrict the naturalmovement and normal behaviors o animals, including swine gestation crates, battery cages or laying hens, andtethered veal crates, be phased out within 10 years. TeCommission additionally recommended that the orce-eeding o owl to produce oie gras, tail docking o dairy cattle, and orced molting o laying hens by eed removalbe ended. Given the capital- intensive nature o theseproduction systems, the Commission also recommendedthat targeted assistance be made available to help contractproducers convert rom intensive con nement systems tomore sustainable systems.

Rece His ry Rela ed he Rec mme da i


National Egg Standard Legislation

Te Humane Society o the United States (HSUS) haspursued actions, either by state legislation, agreements

with producers, or voter re erendum, to ban the use o intensive con nement systems, especially gestation cratesin swine production and battery cages or laying hens.

Te adoption o Proposition 2 by the voters in Cali ornia in 2008 eventually led the United Egg Producers (UEP)and HSUS to agree to pursue a national egg productionstandard.

In 2012, Sen. Dianne Feinstein (DCA) introducedamendments to the Egg Products Inspection Act to makeenriched colony housing the national standard orlaying hens163. Te legislation was based on the agreementbetween the HSUS and UEP. It would require theadoption o enriched environments over a 15- to 18-yeartransition period. Tese enriched environments include a doubling o cage size, nesting boxes, and scratching areas,

prohibition o eed or water withdrawal to extend thelaying cycle, and prohibition o excessive ammonia levelsin henhouses.

Te bill would also require transparent labeling o cagedand cage- ree hens. Additionally, it would prevent statesand localities rom adopting requirements that exceedthose outlined in the legislation regarding minimum oorspace and enrichments or egg-laying hens.

Te bill was not approved in the 112th Congress and wasreintroduced in the 113th Congress. While the bill hasa number o industry and animal wel are organizationsupporters, several groups representing other animalindustries, such as the National Pork Producers Council,National Chicken Council, and the National CattlemensBee Association, oppose it because o concerns that it willopen the door or improved standards or livestock andbroiler production. An e ort by Sen. Debbie Stabenow (DMI) to add the provisions to the 2013 Farm Bill wasabandoned a ter pressure rom bee and pork producersthreatened the passage o the overall Farm Bill i it wasincluded164. Tere has also been concern among someanimal wel are advocates that the bills passage would tiethe hands o states seeking to make urther improvements(e.g., see http://stoptherotteneggbill.org/). In responseto these criticisms, bill proponents point out that the

requirements or labeling also included in the amendments would generate higher consumer demand or cage- reeeggs165.

Proposed Farm Bill Amendment to Overturn Animal Wel are Protections

In 2012, Rep. Steve King (RIA) success ully added anamendment to the House version o the Farm Bill that

would have prevented states rom denying the trade o agricultural products rom other states that produced thegoods in line with ederal law and their own state laws166.


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In short, this would prevent a state rom requiring thatanimal products imported rom other states meet the rststates animal wel are standards167. While the 2012 FarmBill was not enacted, Rep. King success ully reintroducedthe amendment during the 2013 Farm Bill debate inthe House. Tis e ort is in response to 2010 legislationpassed in Cali ornia that required all eggs, including those imported rom another state, to also meet theanimal wel are standards established by Cali ornias 2008

Proposition 2168.


We could not nd evidence o ederal regulatory e orts tophase out intensive con nement.


HSUS-led state ballot initiatives and legislative actions or animal wel are

As previously noted, a number o states have now enacted legislation, passed ballot measures, ornegotiated agreements that phase out some o theintensive con nement practices the Pew Commissionrecommended ending. Te HSUS has been instrumentalin the adoption o these restrictions.

Since early 2008, the HSUS has success ully led theollowing e orts at the state level: 1) a bill outlawing gestation crates in Colorado (2008); 2) a ballot initiativephasing out gestation crates, veal crates, and battery cagesby 2015 in Cali ornia (2008); 3) a bill outlawing gestationcrates in Maine (2009); 4) a bill outlawing gestation andveal crates in Michigan (2009); 5) a bill outlawing taildocking o cattle in Cali ornia (2009); 6) a bill outlawing the sale o whole eggs rom caged hens in Cali ornia (2010); and 7) a bill outlawing gestation crates, veal crates,and tail docking in Rhode Island (2012).

O the above e orts, the 2008 Cali ornia ballot initiative was the highest pro le. Passed with a 63.4 percentmajority 169, the initiative bans the con nement o pregnant sows, calves raised or veal, and laying hens ina manner that does not allow them to turn around reely,

lie down, stand up, and ully extend their limbs170

. Temeasure also imposes nes and up to six months in jail orviolators o the law.

Whistleblower Suppression Legislation

In response to an increasing number o undercoverexpos videos and images released by animal wel areorganizations documenting cruelty in industrial armanimal operations, a number o states have introduced new legislation to prevent advocates rom obtaining ootage atagricultural operations. While laws banning unauthorized

lming and photography in animal production acilities were rst enacted in the 1990s, whistleblower suppressionlaws have resur aced again since the publication o thePew Commission report. Tese laws have now becomecommonly known as ag-gag laws by advocates and themedia.

Since 2008, a growing number o states have proposedlegislation: 1) banning unauthorized lming or

photography in agricultural acilities, 2) prohibiting animal advocates rom gaining employment at agriculturalacilities under alse pretenses, and/or 3) stipulating thetime rame in which animal abuse evidence must bepresented to authorities. Tese proposed laws have beenintroduced in states including Arkansas, Cali ornia,Indiana, Nebraska, New Hampshire, New Mexico,North Carolina, Pennsylvania, ennessee, Wyoming, andVermont 171; 172. A number o these e orts have ailed topass, been vetoed (most recently in ennessee173), or arestill under consideration. However, Iowa 174, Utah 175, andMissouri175 had all enacted some orm o whistleblowersuppression legislation by April 2013. Te rst chargesunder the Utah law were led against a woman taking cellphone video ootage o a slaughterhouse in February 2013.Te charges were subsequently dropped, as she appearedto be on public property while lming 176.

Owing in part to the increasingly negative public opiniono these laws, opposition has also been growing among industry stakeholders. An April 2013 editorial in theindustry-oriented publication Meatingplace argued againstthe ocus on whistleblower suppression laws and notedthat industry should be taking action long be ore anactivist has the chance to get involved177.


We could not nd evidence o state regulatory e orts tophase out intensive con nement.

Li iga i

We could not nd evidence o litigation e orts to phaseout intensive con nement.


Gestation Crate Agreements with Companies

In addition to working at the state and ederal level, HSUSand other animal wel are groups have worked closely withmajor ood companies to phase out the use o gestationcrates. A list o some o the major companies that haverecently committed to phasing out the use o gestationcrates in their supply chains can be ound at: www.humanesociety.org/issues/con nement_ arm/timelines/timeline_ arm_animal_protection.html


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Cage- ree Egg Agreements with Companies

Many major ood comp