A holistic solution for antibiotic resistance: phasing out factory farms in order to protect human health.
Although FDA claims that the voluntary approach is the most successful and effective method, not all companies immediately complied with the FDA guidance. (130) FDA gave the twenty- six animal drug manufacturers ninety days to respond with an intent to comply with guidance requesting that the industry withdraw use of antibiotics for growth purposes. (131) By March 2014, twenty-five of the twenty-six drug companies responded with affirmation of their compliance. (132) In June 2014, FDA received full industry compliance including an agreement to engage in FDA's recommended strategy. (133)
According to a recent analysis by the Pew Charitable Trusts, 66 of the 287 drugs initially affected by FDA's recent guidance were approved for disease prevention at volumes which are "fully within the range of growth promotion dosages and with no limit on the duration of treatment," suggesting there may be no detectable difference in the distribution of antibiotics for non-therapeutic growth promotion and drugs for sub-therapeutic disease prevention. (134) Of these sixty- six drugs, FDA considers twenty-nine as "critically important" and thirty- seven as "highly important" for humans. (135) The Pew analysis suggests that the inability to distinguish the labels for preventive and growth promotion uses may allow the injudicious use of antibiotics for disease prevention to persist on farming operations. (136) The report also found that the "26 drugs approved for disease prevention are labeled to include 'maintain[ing] weight gain' in the presence of vague illnesses, such as 'respiratory' disease.'" (137) FDA does not regard labels referencing "weight gain" to be intended for growth promotion despite the explicit reference to weight gain. (138)
In 2011, Natural Resources Defense Council, Inc. v. United States Food and Drug Administration concluded that FDA must take action with respect to the 1977 proposal to prevent tetracyclines and penicillin from being administered to livestock frequently for animal growth. (139) On appeal, the decision was overruled in 2014 by a split panel, and the Second Circuit found that FDA's 1977 initial finding that use of antibiotics for animal growth is unsafe does not require the agency to issue a complete ban. (140) The issue presented was whether under the FD&C Act, FDA is required to proceed with withdrawal hearings of certain antibiotics used for growth promotion in animal feed based on the Agency's findings in 1977. (141) The Second Circuit reasoned that Congress' intent was not to compel FDA to hold hearings whenever Agency officials have scientific concerns regarding the safety of animal drug usage. (142) Conversely, the one-judge dissent concluded that FDA "shirked its statutory responsibilities" by refusing to address the safety concerns regarding the initial findings in 1977 that growth enhancement use of antibiotics in animal feed is dangerous. (143) The majority ruled, however, that under the FD&C Act, the authority to withdraw a drug's approval is unambiguously admissible only after "due notice and opportunity for hearing" is afforded to the affected pharmaceutical manufacturers and a final finding regarding that particular drug is made. (144) The controversial ruling motivated the public to urge Congress to give authority to FDA to revoke approval once FDA has made an initial finding that a drug is unsafe. (145) Moreover, FDA admitted that the approach requiring an initial finding, hearing, and another final finding for each drug to be ineffective, timely, and cost consuming. (146) To date, FDA has only withdrawn approval of one antibiotic in animal feed after a hearing and final determination was made. (147)
FDA's action with regard to combating antibiotic resistance has also been scrutinized for not thoroughly investigating antibiotic use in animals and its link to resistance in humans. (148) FDA regulatory authority includes the research of antibiotic resistance and its effects as well as to inform users of animal antibiotics about proper use. (149) Although FDA collects data from pharmaceutical companies about antibiotics sold for use in animal feed, it does not collect data with respect to the specific drugs farmers administer into feed, or for what purposes the drugs are being used. (150) In FDA's 2012 Summary Report, the Agency admitted its inability to distinguish between the different types of uses for each of the antibiotics sold. (151) Thus, FDA still lacks crucial information and factors necessary for understanding antibiotic resistance, its effects, and successful ways to eliminate the threat of resistance. (152)
Congress reacted to these concerns by implementing a reporting requirement, instructing pharmaceutical companies to supply its sales data to FDA. (153) Under the Animal Drug User Fee Amendments Act ("ADUFA"), passed in 2008, FDA is directed to collect data regarding: the amount of each antibiotic sold by "container size, strength, and dosage form;" "the quantities distributed domestically and quantities exported;" and a "listing of the target animals, and the indications and production classes on the approved label." (154) The Act, however, does not compel FDA to collect information regarding the specific animals receiving the antibiotics, or the purpose the antibiotics serve. (155)
B. USDA's Role in Combatting Antibiotic Resistance
USDA's mission centers on analyzing antibiotic use on farms in order to develop strategies and alternatives that would decrease overall antibiotic administration. (156) Although FDA has primary responsibility over drugs administered to livestock, the USD A also plays a role in researching antibiotic resistance. (157) For instance, two major efforts run by the USD A gather data regarding livestock producers' antibiotic use related to animal health and farm management practices. (158) Specifically, the .Animal Plant and Health Inspection Service ("APHIS") administers the National Animal Health Monitoring System ("NAHMS"), which collects information regarding methods by which antibiotics are given to livestock, the preferred types of antibiotics used for certain diseases, and in which scenarios farmers administer the drugs. (159) Additionally, under the USDA, the Economic Research Service ("ERS") collects information about farm antibiotic use through the Agricultural Resource Management Survey ("ARMS") and observes how production practices affects the producer's financial performance. (160) The 2011 United States Government Accountability Office report found these efforts remain largely inconclusive and inadequate in their research and findings. (161) Specifically, the report noted that NAHMS does not "monitor trends of antibiotic use over time" and similarly, ARMS does not "survey the same farms over time." (162) Furthermore, both NAHMS and ARMS are voluntary for livestock producers. (163)
The USDA also has authority to inspect animal products for unlawful antibiotic residue levels. (164) Under the FD&C Act, FDA set out specific, legal levels of antibiotic residues permitted in meat and dairy products. (165) The USDA's Food and Safety Inspection Sendee ("FSIS"), under the U.S. National Residue Program, examines meat, poultry, and egg products for antibiotic residue levels at processing plants to ensure the products do not contain illegal drug residue quantities. (166)
C. The Preservation of Antibiotics for Medical Treatment Act
The Preservation of Antibiotics for Medical Treatment Act ("PAMTA") if enacted, would amend the FD&C Act. (167) The proposed Act requires an applicant seeking approval of a new animal drug that is "a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug." (168) PAMTA's main objectives focus on phasing out non-therapeutic antibiotic use on factory farms, while requiring FDA to use the same standards for new applicants seeking approval. (169) This Act would allow FDA to revoke approval of antibiotics for non-therapeutic use in animal feed, replacing the current burdensome withdrawal process. (170) It is unlikely, however, that PAMTA will be enacted due in major part to pressure by the pharmaceutical and meatpacking industries. (171)
D. Industry Pressure and its Effect on Antibiotic Resistance
Federal laws and regulatory agencies have moved cautiously with respect to protection against antibiotic resistance due in large part from industry pressures. (172) PAMTA, for example, faced major challenges since its introduction in 1990 due to pressure from the meatpacking industry. (173) Many large meatpacking producers own factory farm animals and contract with independent farmers to raise the livestock until slaughter. (174) Over the past decades, meatpacking companies created a challenging environment for small hog farms to survive. (175) The pressure forced factory farmers to adopt larger and faster methods of operation in order to abide by production and marketing contracts with meatpackers. (176) For instance, Smithfield, the largest pork producer in the world, requires the factory farms it contracts with to upgrade and expand facilities and warehouses, requiring high levels of investment on the part of farmers. (177) These upgraded facilities enable farmers to place larger amounts of animals together in one warehouse in order to produce more meat. (178) As a result, hog farms become extremely dependent on preserving their relationships with meatpacking companies. (179) Ultimately, farmers are incentivized to grow animals to proper slaughter weight as quickly as possible with as efficient use of feed as possible. (180) If a processor is not satisfied with the contracting farm, it may cancel the contract with the factory farmers, without any recourse to pay the farm's loans on the large warehouses and machinery required to fulfill their contracts. (181) Consequently, the biggest meat-packers retain control over farmers, and preserve large, confined farming operations requiring large amounts of antibiotics needed to keep farm animals healthy and alive. (182)
FDA and pharmaceutical companies had little contact with one another prior to the 1970s. (183) Today, pharmaceutical companies exert significant political power and social influence over governmental agencies, such as FDA. (184) Some argue that misuse of antibiotics on factory farms creates a highly profitable market for the pharmaceutical industry. (185) Between 2010 and 2013, pharmaceutical companies spent approximately 123 million dollars to lobby against PAMTA. (186)
Current Unites States laws fail to recognize that the interconnected relationship between animal welfare and human health necessitates laws to address and eliminate current factory-farming practices in order to prevent antibiotic resistant infections. (187) Both Congress and FDA focus on attempting to limit the amount of drugs used in animal feed, rather than emphasizing the need to phase out confinement and unsanitary CAFO conditions, which require the extensive use of drugs to prevent animal disease. (188) The solution to antibiotic resistance should start with stronger laws and regulations aimed to transition away from CAFOs, rather than creating stricter regulations of antibiotic use in animal feed. (189)
A. FDA's Inadequate Attempt to Remediate Antibiotic Resistance
FDA's new voluntary guidance purports to decrease antibiotic resistance by limiting antibiotic use in animal feed, however, the guidance only phases out non-therapeutic utilization for growth enhancement. (190) Thus, FDA ignores the current prevalent, sub-therapeutic use for disease prevention, which compensate for inhumane and unsanitary farm conditions. (191) Preemptive use of antibiotics has even been considered by FDA to be therapeutic and appropriate, suggesting the Agency's inability to withdraw drugs for preventive use due to current factory farming practices. (192)
Moreover, antibiotics used for non-therapeutic growth enhancement and sub-therapeutic preventive measures are likely used synonymously by CAFOs. (193) FDA condones ambiguous antibiotic labeling by allowing "weight gain" indications on disease prevention drug labels, and thus inadvertently upholds the injudicious use of antibiotics that the agency claims to be ending. (194) Furthermore, FDA guidance ignores the fact that low-dose, non-therapeutic growth promotion drug dosages and sub-therapeutic disease prevention dosages have become indistinguishable on CAFOs. (195) Therefore, by targeting solely the elimination of growth promotion use, FDA fails to diminish antibiotic resistance; instead, farmers can continue using the same amount of antibiotics by designating them for disease prevention purposes. (196) Consequently, the real danger is the rampant utilization of drugs for preventive use. (197) Furthermore, FDA does not collect data regarding how farms administer drugs or what purposes the drugs serve, and thus has inadequate research which limits the agency's ability to distinguish between growth enhancement and disease prevention use. (198) As a result, FDA's mere guidance aimed at banning antibiotic use for only growth purposes is unlikely to lead to a reduction in antibiotic resistance in humans. (199)
FDA disguises the new guidance's flaws by focusing on the fact that its strategy will now require the transition from over the counter antibiotics to requiring veterinary prescription. (200) The plan directs "veterinarians to look for evidence that preventive uses are effective and can target specific disease-causing bacteria." (201) FDA justifies the continued use of antibiotics for disease prevention by stating that all medically important drugs will be used judiciously and be proscribed under veterinarian oversight; however, the agency fails to account for the reality that most farm animals remain at risk for disease, relying on constant distribution of drugs in order to stay healthy. (202) Therefore, this will not resolve the problem because CAFOs will continually use an abundance of medically important antibiotics as long as current farming practices are upheld. (203) Ultimately, FDA's guidance only exists as a superficial progression because it fails to support a long-term, holistic solution of abandoning the industrial farm and ignores prevalent, preemptive sub-therapeutic antibiotic use in CAFOs. (204)
Both FDA guidance and the USDA's limited research regarding factory farm antibiotic use demonstrate both agencies' lax approaches. (205) These strategies focus on attempting to design plans to limit antibiotic use, rather than focusing on ways to eliminate extreme animal confinement and inhumane conditions on factory farms. (206) Agency efforts need to emphasize and execute plans that would focus on the phase out of CAFOs in order to create meaningful change. (207)
B. Courts' Refusal to Require FDA to Withdraw Medically Important Drugs
In 2014, the Second Circuit refused to require FDA to withdraw tetracyclines and penicillin administered in animal feed, determining that the drug withdrawal process does not require FDA to withdraw antibiotics any time the Agency has initial concerns regarding a drug's safety. (208) The Second Circuit's reasoning demonstrates its reluctance to compel agencies, such as FDA, to take action against clear Congressional intent. (209) Thus, the holding insinuates that courts are not adequate forums to motivate profound change in FDA's action to combat antibiotic resistance. (210) Rather, prompting transformation through Congress is the only effective route to proceed with significant change. (211) Legislation addressing animal welfare on farms is essential to overcome antibiotic resistance in humans. (212)
C. Congress and Agency Traditions: Regulation "After-the-Fact"
The only way to phase out extensive, recurrent antibiotic use is to phase out the origin of the problem: the confinement, inhumane and unsanitary conditions on factory farms. (213) FDA and USD A, however, lack the authority to mandate standards for factory farming operations. (214) Both USDA and FDA utilize an "after-the-fact" approach; FDA attempts to regulate inevitable and significant antibiotic use in animal feed, while USDA only examines animals immediately prior to, and after, slaughter. (215) These two approaches unsuccessfully attempt to mitigate antibiotic resistant infections, rather than create a solution by addressing animal welfare on farms. (216) Ultimately, FDA ignores the crucial link that the transfer of antibiotic resistance can only be significantly reduced by improving animal welfare on factory farms. (217) Therefore, FDA's power is insufficient to fully safeguard the public against antibiotic resistance because the agency lacks power to impose confinement and sanitation standards at the farm-level in order to improve animal welfare. (218) Until Congress expands USDA power or FDA authority to take proactive measures and regulate on farm practices by mandating specific standards for clean living conditions and prohibiting extreme confinement, antibiotic resistance will not significantly decrease. (219)
The USDA is in a better position than FDA to regulate animal welfare considering USDA's current authority to inspect and regulate organic farms requiring "continuous and year-round access to outdoors" for livestock. (220) Moreover, USDA certified organic farm meat guarantees the animals were raised without antibiotics, a clear indication that animals with improved living conditions do not need antibiotics to prevent or treat disease. (221) Because the USDA has mechanisms in place to monitor animal welfare on organic farms, the Agency would be appropriately suited to regulate humane animal conditions. (222) However, only a mandate from Congress would enable USDA to set out animal welfare regulations on all farms. (223)
Congress' insufficient approach in recent years also fails to correctly assess the fundamental problem of animal welfare factory farms. (224) The PAMTA bill illustrates the "after-the-fact" approach by commanding the withdrawal of medically important antibiotics for non-therapeutic use or growth promotion and thus clearly disregards the root of antibiotic resistance by ignoring the necessity of repeated sub-therapeutic dosing on CAFOs in order to prevent anticipated disease. (225) Moreover, the proposal does not account for the need to phase out factory farming practices, an essential prerequisite necessary to end prevalent, repeated use of antibiotics for disease prevention on factory-farms. (226)
D. Agency and Congressional Power at a Halt
Despite FDA's apparent flaws and criticism regarding their voluntary approach to phase out antibiotic use for growth promotion, a complete ban on all sub-therapeutic, preemptive use of antibiotics is not realistic or safe with the current practices utilized by factory farming operations. (227) Although FDA or the USDA need authority to monitor and regulate humane standards for factory farming in order to diminish antibiotic resistance, it is unlikely Congress would enact legislation delegating this power to either agency, due to the strong influence exerted by pharmaceutical and meatpacking industries. (228) These impediments prevent meaningful transformation at the farm-level that would ultimately overcome the transfer of antibiotic resistance from animals to humans. (229)
Confinement and other inhumane CAFO conditions create a market which enables the veterinary pharmaceutical industry to sell significant amounts of antibiotics for disease prevention each year. (230) Pharmaceutical companies have demonstrated a strong influence over Congress and FDA. (231) FDA's objective to protect human health against antibiotic resistant infections directly conflicts with pharmaceutical companies' interest to continue to sell large quantities of antibiotics to factory farms. (232) FDA's insufficient guidance contributed to the pharmaceutical industry's quick and undisputed compliance with the agency's recommendations. (233) This evidence demonstrates the powerful control the industry employs, contributing to the challenges in decreasing antibiotic resistance. (234)
The meatpacking industry also perpetuates the cycle of antibiotic resistance by sustaining current farm conditions; meat-processing companies sustain severe confinement by forcing farmers to make larger, but more overcrowded, warehouses for livestock. (235) Consequently, the immense pressure placed on farmers to raise animals for slaughter quickly forces farmers to rely on, and ultimately uphold, CAFO conditions. (236) Thus, laws designed to eliminate industry power over farmers, which uphold confinement and inhumane customs, are crucial to discontinue the excessive subtherapeutic use of antibiotics. (237)
Transforming the way farmers use antibiotics is challenging because the use directly correlates to current CAFO practices. FDA claims the Agency's recent guidance will reduce antibiotic resistance in humans by phasing out uses for growth enhancement in farm animals. However the guidance ultimately overlooks and ignores the significant underlying problem: sub-therapeutic dosing for disease prevention. FDA's inadequate research and inability to distinguish between preemptive use and growth promotion reveal flaws and limitations in the agency's action. Although critics attack FDA for its voluntary strategy, urging the Agency to take a more powerful approach, and encouraging the passage of bills such as PAMTA, these "stronger" actions do not coincide with the reality of modern farm conditions. Furthermore, these strategies are defective; they emphasize minimizing the problem "after-the-fact," rather than mitigating the problem at its origin. Alternatively, legislation designed to gradually phase out the CAFO model would impact human health significantly and reduce antibiotic resistant infections. However, industry barriers prevent Congress from dictating humane standards or delegating power to FDA or LTSDA to oversee and enforce confinement and sanitation regulations. Until government agencies are able to regulate confinement and other inhumane farm practices, free from control and influence of the industry, antibiotic resistance will persist.
(1) Antibiotic/Antimicrobial Resistance, CENTERS FOR DISEASE CONTROL AND PREVENTION, http://www.cdc.gov/drugresistance/ (last visited Apr. 18, 2015) (providing overview of antibiotic resistance infections in United States). See also Jennifer Nomura, Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals, 15 MINN. J.L. SCI. & TECH. 585, 587 (2014) (explaining antibiotic resistance in humans results in hospitalization, increased death risk, other health complications).
(2) See 2009 Summary Report on Antimicrobials Sold or Distributed for Use in Food--Producing Animals, FDA (2014), available at http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM231851.pdf (reporting amount of antibiotic sold for farm animals use); The Issue: Antibiotics and the Food Husbandry Industry, SUSTAINABLE TABLE, http://www.sustainabletable.org/257/antibiotics (last visited Apr. 20, 2015) (discussing antibiotic resistant infections originating on factory farms).
(3) See Ariele Lessing, Killing Us Softly: How Sub--Therapeutic Dosing of Livestock Causes Drug--Resistant Bacteria in Humans, 37 B.C. ENVTL. Aff. L. Rev. 463, 464 (2010) (discussing human health threats as a result of using antibiotics in animal feed). When drug resistant bacteria builds up in a farm animal's intestine, and the animal is slaughtered, the bacteria is released and spread to the processed meat. Id. at 475. When a human eats the processed meat, he or she is also consuming the drug--resistant bacterial strains that are formed in the intestine. Id. See also Krans, infra note 125 (outlining amount of antibiotics used on farms each year and detrimental effects on humans). Around 29.9 million pounds of antibiotics are administered to animals on farms each year. Id. See also Feedlot 2011, Part III: Trends in Health and Management Practices on U.S. Feedlots, 1994-2011, U.S.D.A. (2013), http://www.aphis.usda.gov/animal_health/nahms/feedlot/downloads/feedlot2011/Feed11_dr_Part%20III.pdf (finding more than 80 percent of various types of farms administer antibiotics for growth or health).
(4) Sabrina Tavernise, Antibiotics in Livestock: F.D.A. Finds Use Is Rising, N.Y. TIMES, Oct. 3, 2014, at A12, available at http://www.nytimes.com/2014/10/03/science/antibiotics-in-livestock-fda-finds-use-is-rising.html (discussing the concern of rising use of antibiotics in recent years). Research has shown antibiotic use in animal feed directly leads to antibiotic resistant bacteria in humans. Id. Antibiotics administered to animal feed on factory farms are so rampant and are given to healthy animals for prevention of illness and disease. See also David Siegel, Sens. Press FDA For Plan On Antibiotic Use In Farm Animals, LAW360 July 28, 2014, 5:59 PM), http://www.law360.com/articles/561727/sens-press-fda-for-plan-on-antibiotic-use-in-farmanimals (discussing recent FDA action and public reaction).
(5) See Lessing, supra note 3, at 464. The shift from small, family owned farms to the rise of large factory farming operations have caused the need for sub-therapeutic doses of antibiotics in animal feed in order to keep animals healthy. Id.
(6) See infra Part I.B.i.-v. (discussing CAFO conditions necessitating sub-therapeutic administration of antibiotics to prevent disease).
(7) See infra Part I.D. (describing sub-therapeutic administration of drugs result in antibiotic resistance in humans).
(8) Anastasia S. Stathopoulos, You Are What Your Food Eats: How Regulation of Factory Farm Conditions Could Improve Human Health and Animal Welfare Alike, 13 N.Y.U.J. LEGIS. & PUB. POL'Y 407, 434 (2010) (proposing that regulation at the farm level could improve human health).
(9) Id. at 433-34. Congress gave the USDA the power to regulate humane standards for treatment of animals under the Animal Welfare Act, however exempted farm animals, which make up ninety-eight percent of all animals in the United States. Id. at 435.
(10) GUIDANCE FOR INDUSTRY #213, NEW ANIMAL DRUGS AND NEW ANIMAL DRUG COMBINATION PRODUCTS ADMINISTERED IN OR ON MEDICATED FEED OR DRINKING WATER OF FOOD- PRODUCING ANIMALS: RECOMMENDATIONS FOR DRUG SPONSORS FOR VOLUNTARILY ALIGNING PRODUCT USE CONDITIONS WITH GFI #209, FDA (2013), available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf. See also Siegel, supra note 4. Many criticize that this voluntary plan will not solve the problem, as animals will continue to receive antibiotics to prevent illness and disease. Id. See also infra Part II.A. (discussing FDA's role in protecting human health form antibiotic resistance); infra Part II.D. (describing industry pressure on government agencies and other relevant bills). See also Stathopoulos, supra note 8, at 436-37. FDA promotes regulations that ban contaminated food products into the stream of commerce. Id. However, it is not clear whether FDA has the authority to regulate and monitor on farm practices. Id. at 437-38.
(11) See infra Parts II.A-B. (explaining FDA and USDA efforts to curb antibiotic resistance transferred from animals to humans); infra Part I.C. (describing USDA authority to inspect meat and FDA's role to regulate animal feed).
(12) See infra Part I (discussing current CAFO practices that contribute to animal disease and the need for antibiotics).
(13) See infra Part II (outlining agency and congressional action, and current industry pressures).
(14) See infra Part III (analyzing the United States' approach and changes needed to address antibiotic resistance).
(15) See infra Part III (discussing flaws in current law and proposing necessary changes aimed at curbing antibiotic resistant infections).
(16) Bernard E. Rollin, Farm Factories: The End of Animal Husbandry, in The CAFO READER: The. Tragedy of Industrial Animal Factories 6,10 (Daniel Imhoff ed., 2010) (describing good animal husbandry' as beneficial contract between humans and animals).
(18) See Lessing, supra note 3, at 466 (explaining that animals' dietary, physical, and social needs were met at family farms). See also Industrial vs. Family Farms Comparison, BEYOND FACTORY FARMING, http://beyondfactoryfarming.org/get-informed/industrial-vs-family-farms-comparison (last visited Apr. 13, 2015) (outlining differences between traditional farms and industrialized farms). Traditional farms raise livestock without routine use of antibiotics and today these family-owned farms only administer antibiotics to sick animals. Id.
(19) Rollin, supra note 16, at 7 (summarizing factors contributing to the shift to factory farming). See also Myth: CAFOs are Farms, Not Factories, in THE CAFO READER: The TRAGEDY OF INDUSTRIAL ANIMAL Factories 72, 72-74 (Daniel Imhoff ed., 2010) (discussing aspects of the modern CAFO model); Carrie Hribar, Understanding Concentrated Animal Feeding Operations and Their Impact on Communities, NAT'L ASS'N OF LOCAL BDS. OF HEALTH, 2010 at 1-12 (defining CAFOs and outlining effects on environment and surrounding communities), available at http://www.cdc.gov/nceh/ehs/docs/understanding_cafos_nalboh.pdf. "CAFOs are classified by the type and number of animals they contain, and the way they discharge waste into the water supply." Hribar, supra, at 1. See also DONALD D. STULL & MICHAEL J. BROADWAY, SLAUGHTERHOUSE Blues: The Meat and Poultry Industry in North America 21 (2d ed. 2012). Depending on the type of animal raised in each CAFO, a facility will typically contain seven hundred dairy cows, one thousand beef cows, thirty thousand broiler chickens or twenty five hundred hogs. Id. See generally Steve Martinez et al., Focal Food Systems: Concepts, Impacts, and Issues, USDA, May 2010, at 1 (discussing evolution from local to national food sources following World War II), available at http://www.ers.usda.gov/media/122868/err97_1_.pdf. In the early 1900s, most food was bought and consumed from local sources. Id.
(20) Rollin, supra note 16, at 7-8. Agriculture was a way of life for many American farmers but was replaced by technology. See id. Before the modern farm era, farmers raised animals in an environment where the animals could thrive by providing them with adequate food and nutrition, proper medical care, and overall protection necessary for survival. Id. at 10. Humans understood that their care of the animals directly correlated with their own health and well-being. Id. Factory farming evolved when new technologies allowed for raising animals in confined, crowded and inhumane conditions that would have otherwise killed them by disease. Id. at 7-8, 11. See also Wenonah Hauter, Foodopoly: The battle Over the Future of Food and Farming in AMERICA 120 (2012). The shift to factory farming involved "a case of blind faith in technology and a belief that the industry would put public health above private profit". Id. See also Note, Challenging Concentration of Control in the American Meat Industry, 117 Harv. L. Rev. 2643, 2644 (June 2004) (describing how technological advances have helped shaped factory farming today).
(21) See Gaverick Matheny & Cheryl Leahy, Farm-Animal Welfare, Legislation, and Trade, 70 LAW & CONTEMP. PROBS. 325, 328 (2007) (stating "animal health, welfare, and productivity were effectively linked" in traditional farming practices). These advances ultimately promoted the plight of animals in factory farms and produced faster growth and greater production all at cheaper costs. See id. Factory farming operations as they exist today would not be possible without these technologies. See id.
(22) Rollin, supra note 16, at 7-8 (explaining that animals are treated as mere machines on CAFOs). See also Nancy Perry & Peter Brandt, A Case Study on Cruelty to Farm Animals: Lessons learned from the Hallmark Meat Packing Case, 106 MICH. L. Rev. First IMPRESSIONS 117, 118 (2008). "Since the 1950s, a commercial obsession with high-yield production methods and mechanization has replaced the traditional farming practices many still imagine when we think of life on a farm." Id.
(23) Factory Farm Nation: How America Turned Its livestock Farms into Factories, FOOD & WATER WATCH, Nov. 2010, at v, available at http://www.factoryfarmmap.org/wp-content/uploads/2010/11 /FactoryFarmNation-web.pdf. "The average size of factory farms increased 9 percent in five years." Id. "The size of the average large-scale livestock operation increased from 1,018 animal units in 2002 to 1,108 in 2007," and subsequently more animals are crammed onto each farm. Id. See also Animal Waste: What's the Problem?, EPA, http://www.epa.gov/region9/animalwaste/problem.html (last visited Apr. 14, 2015). "There are approximately 450,000 AFOs in the United States." Id. See also HAUTER, supra note 20, at 171-72. "Two out of three hogs are now slaughtered by four of the largest pork processors." Id. These meatpacking companies will slaughter the animals, process the hogs, and even control the farmers who raise the animals under contracts. Id.
(24) Factory Farm Nation, supra note 23, at vi. Three key factors played a role in the evolution of factory farming:
First, misguided farm policy encouraged over-production of commodity crops such as corn and soybeans, which artificially depressed the price of livestock feed and created an indirect subsidy to factory farm operations. Second, unchecked mergers and acquisitions between the largest meatpacking, poultry processing and dairy companies created an intensely consolidated landscape where a few giant agribusinesses exert tremendous pressure on livestock producers to become larger and more intensive. And finally, lax environmental rules and lackluster enforcement allowed factory farms to grow to extraordinary sizes without having to properly manage the overwhelming amount of manure they create. The combination of these trends eroded rural economies, drove independent producers out of business, and allowed the largest livestock operations to dominate animal agriculture in the United States.
Id. See also Perry & Brandt, supra note 22, at 118. Farmers dealt with immense pressures to produce in greater quantities and at lower prices, and thus surrendered to harsh and industrial practices that disregard animals as living beings who can breathe, feel, and think. Id.
(25) See STULL & Broadway, supra note 19, at 11. Even after the revelation of meatpacking conditions, meat-packing processors "remain massive factories, employing hundreds or even thousands of workers." Id. at 4. Concentration of farms has "led to the loss of hundreds of thousands of cow-calf farm [and] hog operators" in America. Id. at 15. Furthermore, "99 percent of the 10 million hogs grown in North Carolina in 2007 came from farms with 1,000 or more hogs, and 44 percent of the state's hog production came from just two counties." Id. See also HAUTER, supra note 20, at 192. The five largest poultry producers Tyson Foods, JBS, Perdue, Sandersen Farms, and Koch Foods sell 70 percent of all chicken consumed in America today. Id. Ninety-eight percent of the chicken eaten in America today is produced under contracts farmers have with the meatpackers, also known as the integrators. Id. at 193. The meatpackers control every step of chicken production from the beginning of the animal's life to the meat counter. Id. at 192. The four largest hog producers in America, Smithfield, Tyson, JBS and Excel control 66 percent of the hog market. Id. at 175. Cargill, Tyson, JBS and National Beef are the largest beef producing companies making up 80 percent of beef sales. Id. at 173.
(26) See STULL & Broadway, supra note 25, at 15. Three components make up agricultural industrialization: intensification, concentration, and specialization. Id. Intensification happens when farmers "increase their purchases of non farm inputs" such as fertilizers, machinery, and agrichemicals in order to "improve yields." Id. Concentration indicates "fewer but larger units use economies of scale to produce a greater share of the output of a particular product or commodity." Id. Specialization means "growing fewer farm products on each farm and in each region." Id. at 16. These three elements of industrial farming are present in the meat and poultry industry. Id. at 17. Many consider the consequences of the industrial farm model to consist of cruel animal confinement, and inhumane practices leading animals' pain and suffering. STULL & BROADWAY, supra note 25, at 83. See also infra Parts I.B.i.-v (discussing problems with industrial farm practices).
(27) Barbara O'Brien, Comment, Animal Welfare Reform and the Magic Bullet: The Use and Abuse of Subtherapeutic Doses of Antibiotics in livestock, 67 U. COLO. L. REV. 407, 413 (1996) (arguing current factory farm conditions require antibiotics due to inevitable disease in animals).
(28) See Tutting Meat on the 'Table: Industrial Farm Animal Production in America, THE PEW COMMISSION ON INDUS. FARM ANIMAL PRODUCTION, available at http://www.ncifap.org/_images/PCIFAPSmry.pdf (last visited Apr. 17, 2015) (providing overview of CAFO conditions and recommending to phase out and improve current practices). See also infra Parts I.B.i.-v. (outlining various practices utilized by factory farms).
(29) See Stathopoulos, supra note 8, at 412 (discussing health problems on CAFOs and subsequent high death rates).
(30) See Bonnie M. Marshall & Stuart B. Levy, Food Animals and Antimicrobials: Impacts on Human Health 24 CLINICAL MICROBIOLOGY REVS. 718 (2011) (discussing antibiotic use on CAFOs and possible link to antibiotic resistant bacteria in humans). See also infra notes 70-71 and accompanying text (describing how much meat comes from CAFOs versus organic farms).
(31) See Stathopoulos, supra note 8, at 411 (discussing factory farm's main purpose to grow animals as quickly as cheaply as possible). Concentration of farms has allowed farms to keep productions costs low. Id. See also STULL & BROADWAY, supra note 25, at 15. For instance, modern farms today are described as follows:
[c]oncentration means fewer but larger units use economies of scale to produce a greater share of the output of a particular product or commodity. Producing calves on a ranch with 500 cows costs nearly 50 percent less per cow than on a ranch with fewer than 50 cows. Similarly, production costs on farms with more than 3,000 hogs are estimated to be nearly a third less per hog than on farms with fewer than 500 hogs.
(32) See Stathopoulos, supra note 8, at 411 (discussing welfare of the farm animals).
(33) See Dairy and Meat Factories, FOOD & WATER WATCH, http://www.foodandwaterwatch.org/food/factoryfarms/dairy-and-meat-factories/ (last visited Apr. 15, 2015) (describing factory farms and the increase of CAFOs around the country).
(34) See Stathopoulos, supra note 8, at 412 (describing gestation crates for pregnant pigs). See also HAUTER, supra note 20, at 170 (describing hog farm conditions). Pigs are inseminated, fed and are forced to deliver their piglets in small cages where they cannot turn around. Id. Around forty 250-pound male pigs will usually live in a pen the size of a small apartment and even trample each other to death. Id. See also Pigs, ANIMAL WELFARE INST., https://awionline.org/content/pigs (last visited Apr. 15, 2015). The gestation period lasts four-months, during which pigs receive no physical or mental stimulation. Id.
(35) See HAULER, supra note 20, at 206 (outlining 2010 undercover investigations by the Humane Society displaying crowded conditions at egg farm). Undercover investigations executed by animal rights organizations revealed the severe confinement experienced by all farm animals and prompted change. Id. For instance, during a Humane Society undercover operation in 2010, an activist documented the living conditions of birds at an egg farm and found that each bird only had a space of an eight by eleven inch sheet of paper and found eggs covered in feces. Id.
(37) Veal Crates, The HUMANE SOC'Y OF THE U.S. (Feb. 22, 2013), http://www.humanesociety.org/issues/confmement_farm/facts/veal.html. Calves are tethered by their necks to inhibit movement and are immobilized for their 16-week long lives. Id.
(38) HAUTER, supra note 20, at 206 (discussing confinement conditions for animals on farms such as meat chickens).
(39) Id. at 170. Pigs were not always raised in this cruel manner, and the transformation with respect to hog farms happened very quickly. Id. at 170-71. "In 1992, less than a third of U.S. hogs were raised on farms with more than two-thousand animals, but by 2004, four out of five hogs came from one of these giant, crowded operations, and by 2007, 95 percent were." Id. at 171. An analysis by Food and Water Watch revealed that "between 1997 and 2007, 4,600 hogs were added to a factory farm every single day, increasing the total to more than 62 million." Id. This rapid increase lead to the overcrowded and unsanitary conditions on current hog farms. Id. at 170.
(40) See HAUTER, supra note 20, at 158. The cattle are packed together so tightly to eliminate any loss of calories, and eliminating any capability' of movement. Id. Up until the 1960s, cows were raised on an open range pasture and were solely grass-fed. Id. Today, cows spend their lives in steel-pens, compressed together, and fed an unnatural diet comprised of mainly corn. Id. Cows on feedlots today are unable to move in their pens, and sleep in their own waste. Id. In order to gain calories and fat quickly, cows are fed an unhealthy feed consisting of "corn by-products derived by ethanol production, animal by-products, cottonseed meal, grains, and alfalfa." Id.
(41) See HAUTER, supra note 20, at 158 (discussing unsanitary' conditions on cow feedlots).
(42) See Stathopoulos, supra note 8, at 412. "[F]armed animals in intensive confinement have high on-farm death rates: approximately ten percent generally, ranging from four percent for cattle, twelve percent for turkeys, fourteen percent for pigs, and up to twenty-eight percent for some types of chickens." Id. See also Robyn Mallon, The Deplorable Standard of luring Faced by Farmed Animals in America's Meat Industry and How to Improve Conditions by Eliminating the Corporate Farm, 9 MICH. ST. U. J. MED. & L. 389, 404 (2005) (highlighting cruel conditions animals endure on factory farms). See also HAUTER, supra note 20, at 123. "Cattle spend their last three to four months crowded together in megasize feedlots, where they wallow in their own waste." Id.
(43) See STULL & Broadway, supra note 25, at 21 (explaining how CAFOs have become the "norm" for producing livestock).
(44) See Stathopoulos, supra note 8, at 412, 415 (discussing various diseases animals contract from close confinement and waste). See also David J. Wolfson, Beyond the Law: Agribusiness and the Systemic Abuse of Animals Raised for Food or Food Production, 2 ANIMAL L. 123, 134 (1996) (discussing animal cruelty and weak protections farm animals receive on state and federal basis); Animal Welfare, SUSTAINABLE TABLE, http://www.sustainabletable.org/274/animal-welfare (last visited Apr. 15, 2015) (discussing animals' lives on factory farms and cruel conditions).
(45) See HAUTER, supra note 20, at 170 (discussing various toxins emitted from hog waste which is not properly disposed of).
(46) Id. See also Stathopoulos, supra note 8, at 414. Factory farms are not equipped to deal with animal waste. Id. Confined animals continue to sit in their waste until it falls through the fall or it is washed away. Id. Over one hundred illness-causing pathogens were found in waste contained on hog farms. Id.
(47) See Stathopoulos, supra note 8, at 416. "[A]pproximately ten to fourteen percent of factory-farmed pigs die of illness before they can even reach the usual slaughter age of about six months old." Id. See generally Waste Management, SUSTAINABLE TABLE, http://www.sustainabletable.org/906/waste-management (last visited Apr. 15, 2015). "Manure is usually stored for many months, often in giant outdoor pits known as lagoons. As it decomposes, the manure emits harmful gases such as ammonia and hydrogen sulfide." Id. On traditional farms, where animals graze on pastures, manure is excreted directly onto the land, serving as a fertilizer and recycling nutrients back into the soil. Id. However, on industrialized farms, animals drop their manure in the houses and it remains in where they are housed. Id. CAFOs are unable to use the excessive waste productively or utilize a safe way to dispose of it, however continue to operate dangerous confinement systems. Id.
(48) Stathopoulos, supra note 8, at 416. "The crowded, filthy conditions on factory farms are breeding grounds for bacteria, viruses, and fungi to grow and spread from one animal to another." Id. at 415.
(50) Id. at 415.
(51) Matheny & Leahy, supra note 21, at 329. Farmers lack economic incentives to care or treat for sick or injured animals and most animals on farms do not receive any veterinary care. Id. "In the United States, there are only 220 veterinarians responsible for the care of more than nine billion farm animals." Id. Hut see From Farm to Family Fable, Am. VETERINARY Med. Found., http://www.avmf.org/programs/main/from-farm-to-the-family-table/ (last visited Apr. 20, 2015) (describing veterinarian's role in treating farm animals). Veterinarians vaccinate, examine, diagnose, and treat animals on the farm when they are ill. Id.
(52) Matheny & Leahy, supra note 21, at 329 (discussing how CAFO conditions deny animals form partaking in natural behaviors); Stathopoulos, supra note 8, at 415 (explaining how animals suffer mentally and feel stress due to close confinement and unsanitary conditions). See also Human Health Impacts of Factory Farming, ANIMAL WELFARE INST., https://awionline.org/content/humanhealth-impacts-factory- farming (last visited Apr. 20, 2015) (explaining confinement induced stress increases the frequency of illnesses in animals). In one example, at a Smithfield hog farm, animals ranging from four hundred to five hundred pounds are enclosed row after row, trapped inside iron crates seven feet long and twenty-two inches wide. Id. See also Matthew Scully, Fear Factories: The Case for Compassionate Conservatism--for Animals in THE CAFO READER: THE Tragedy of Industrial Animal Factories 22 (Daniel Imhoff ed., 2010). Scully describes his first- hand account of hogs on factory farms: "chewing maniacally on bars and chains, as foraging animals will do when denied straw, or engage in stereotypical nest building with the straw that isn't there, or else just like there like broken beings." Id.
(53) Stathopoulos, supra note 8, at 416 (discussing unnatural and unhealthy animal feed contributes to disease). See also Factory Farm Nation, supra note 23 (discussing how farmers have adopted factory farming practices). "The diets fed to factory farm animals increase the concentration and length of time that E. coli, including dangerous strains like 0157:117, survives in manure." Id.
(54) Feed, SUSTAINABLE TABLE, http://www.sustainabletable.org/issues/feed/ (last visited Apr. 20, 2015). Cows' digestive tracts are designed to digest grass, however cows today are mainly fed a grain or corn based diet. Id. Cows raised on grain develop severe health problems such as liver abscesses, bloat and sudden death syndrome. Id. Cows' digestive tracts are designed to digest grass, however are mainly fed a grain or corn based diet. Id. This diet also facilitates mass confinement because cows do not need to be outside in order to eat. Id.
(55) Stathopoulos, supra note 8, at 417 (describing various unnatural substances mixed into animal feed on factor)' farms).
(56) Id. See also HAUTER, supra note 20, at 148. Nearly ninety percent of arsenic fed to chickens is excreted through urine and feces. Id. at 146. Arsenic based feed additives are also used in the turkey and hog industries in order to prevent disease and promote growth. Id. See also Playing Chicken: Avoiding Arsenic in Your Meat, INST. FOR AGRIC. AND TRADE POLICY (Apr. 2006), available at http://www.iatp.org/files/421_2_80529.pdf (discussing a study related to arsenic in chicken feed). According to new studies, arsenic residues might be higher in chicken meat than previously thought. Id. For instance, in a 2006 study by the Institute for Agriculture and Trade Policy ("IATP"), researchers tested arsenic levels in chicken meat sold in stores and fast-food restaurants. Id. Of the 151 retail packages tested, 55 percent had detectable levels of arsenic. Id. The industry estimated that in 2011, nine out of ten chickens consumed by humans had been fed arsenic in their feed. HAUTER, supra at 148.
(57) Stathopoulos, supra note 8, at 418 (describing the practices of administering dead animal parts into feed).
(58) Id. at 418. See also 21 C.F.R. [section] 589.2000-2001 (2009) (prohibiting "animal proteins" in cows' feed). FDA issued the feed ban, which prohibits farmers from using "ruminant feed of any material that contains protein derived from mammalian tissues...." Id. The only regulation is the feeding of dead cattle to other cows is because it results in mad cow disease, which can be passed onto humans by eating the diseased beef. Stathopoulos, supra note 8, at 418. However, factories are able to circumvent this by feeding cattle other waste that contains cow body remnants. Id. See also HAUTER, supra note 20, at 135. After the revelation that feeding cow meat to other cows caused mad cow disease in humans, President Obama banned the use of downer cows for meat, however failed to prohibit other unsafe practices that can spread disease to animals and ultimately to humans, such as continuing the practice of allowing cows to eat poultry litter. Id.
(59) See infra notes 60-63 and accompanying text (describing inhumane practices leading to animal suffering and negative implications for animals).
(60) See Beef Cattle, ANIMAL WELFARE INST., https://awionline.org/content/beef-cattle (last visited Apr. 20, 2015) (describing cruel conditions for cows on feedlots); Con's for Meat, WOODSTOCK FARM Animal Sanctuary, http://woodstocksanctuary.org/learn-3/factory-farmed-animals/cattle/ (last visited Apr. 20, 2015) (describing practices of castration, branding, and dehorning used in many farms today).
(61) Animal Welfare, supra note 44. Tail docking is a practice utilized by factory farms to prevent pigs from biting each other's tails--a behavior only observed in CAFOs. Id.
(63) See A HSUS Report: Welfare Issues with Tail Docking of Cows in the Dairy Industry, HUMANE SOC'Y OF THE U.S. (Oct. 2012), available at http://www.humanesociety.org/assets/pdfs/farm/HSUSReport-on-Tail-Docking-of- Dairy-Cows.pdf (explaining tail docking in cows have contributed to pain and distress in cows); Welfare Implications of 'Teeth Clipping Tail Docking and Permanent Identification of Piglets, Am. VETERINARY MED. ASS'N (July 15, 2015), https://www.avma.org/KB/Resources/LiteratureReviews/Pages/Welfare-implications-of-practices-performed-onpiglets.aspx (discussing negative effects of tail docking on pigs). See also Lessing, supra note 3, at 469 (stating negative implications of tail docking procedures on animals).
(64) Humane Slaughter Act, 7 U.S.C. [section][section] 1901-07 (2006). The USDA-enforced statute requires that: "livestock be rendered insensible to pain before being shackled, hoisted, thrown, cast, or cut." Id. However, this statute does not require to humane treatment for animals during their lifetime, and only applies to slaughter. Id. Furthermore, the statute exempts poultry during slaughter. Id. Twenty-Eight Hour Law, 49 U.S.C. [section] 80502 (2006) (mandating animals during transportation may not be confined for more than 28 hours). The law provides for exceptions due to "accidental or unavoidable causes." 49 U.S.C. [section] 80502(2)(a). Furthermore, the time can be extended to 36 hours by request from the owner. 49 U.S.C. [section] 80502(2)(b). Animal Welfare Act, 7 U.S.C. [section] 2132(g) (2006) (excluding specifically "farm animals ... used or intended for use as food" from protection). See also David J. Wolfson & Mariann Sullivan, Foxes in the Henhouse--Animals, Agribusiness, and the Law: A Modern American Fable, in Animal Rights, available at http://www.animalwelfareadvocacy.org/externals/Foxes%20in%20the%20Henhouse.pdf (explaining that federal laws protecting farm animals only apply during transport or at slaughter). See also Cruel Slaughter Practices, THE HUMANE SOC'Y OF THE U.S., http://www.humanesociety.org/issues/slaughter/ (last visited Apr. 21, 2015). Nine billion turkeys and chickens are "shackled upside down, paralyzed by electrified water and dragged over mechanical throat-cutting blades all while conscious" during slaughter. Id. See generally Rampant Animal Cruelty at California Slaughter Plant: Undercover Investigation Finds Abuses at Major Beef Supplier to America's School Lunch Program, THE HUMANE SOC'Y of THE U.S. (Jan. 30, 2008), http://www.humanesociety.org/news/news/2008/01/undercover_investigation_013008.html. A United States Humane Society investigation revealed workers at a plant pushing cows violently with forklifts and using electric prods to force the diseased and ill cows to walk towards the butchering site. Id.
(65) See FLA CONST, art. X, [section] 21(a) (LexisNexis 2015) (rendering it unlawful to use gestation crates on farms). The Florida statute makes it "unlawful for any person to confine a pig during pregnancy in an enclosure, or to tether a pig during pregnancy, on a farm in such a way that she is prevented from turning around freely." FLA CONST, art. X, [section] 21(a); ARIZ. REV. STAT. ANN. [section][section] 13-2910.07(A)(l)-(2) (LexisNexis 2015). The Arizona statute mandates standards for pregnant hogs and calves and prohibits confinement, which restricts the animals from lying down and "fully extending his or her limbs" or "turning around freely." Id.; OR. REV. STAT. [section] 600.150(2) (LexisNexis 2015). Oregon's statute provides: "A person commits the offense of restrictive confinement of a pregnant pig if the person confines a pregnant pig for more than 12 hours during any 24-hour period in a manner that prevents the pregnant pig from: (a) Lying down and fully extending its limbs; or (b) Turning around freely." Id.; CAL. HEALTH & SAFETY CODE [section] 25990 (LexisNexis 2015). California's statute provides that any person should not "tether or confine any covered animal, on a farm, for all or the majority of any day, in a manner that prevents such animal from lying down, standing up, fully extending his or her limbs and turning around freely." Id.; COLO. REV. STAT. [section] 35-50.5-103 (LexisNexis 2015). The Colorado statute mandating that sows and calves must be able to "lie down, stand up, and turn around without touching the sides of its enclosure." Id.; Me. REV. STAT. Ann. tit. 17, [section] 1039(2) (LexisNexis 2015). The state of Maine prohibits "tethering or confining a covered animal for all or the majority of a day in a manner that prevents the animal from: lying down, standing up and fully extending the animal's limbs; and turning around freely." Id.; MICH COMP. LAWS [section] 287.746(2) (LexisNexis 2015). "Covered animals must not be tethered or confined in a manner that prevents the animal from "lying down, standing up, and fully extending his or her limbs" or "turning around freely." Id.; OHIO CONST, art XIV, [section] 1(A) (LexisNexis 2015) (outlawing new hog farms to use gestation crates and eliminating veal crates by 2017); R.I. GEN. LAWS 1956, [section] 41.1-1-4.1.1-6 (LexisNexis 2015) (banning intensive confinement for calves and gestation crates). See also Elizabeth R. Springsteen, 14 DRAKE J. AGRIC. L. 437 (2009) (delineating current state farm animal protection statutes and relevant proposed state laws). Florida was the first state to address confinement with its ban. Id. at 440.
(66) CAL. HEALTH & SAFETY Code [section] 25990 (mandating that farm animals be able to stand up, lie down, and fully extend limbs); Springsteen, supra note 65, at 448 (describing state laws mandating confinement and humane standards for farm animals).
(67) Frequently Asked Questions, ANIMAL WELFARE APPROVED, http://animalwelfareapproved.org/farmers/faq/ (last visited Apr. 21, 2015) (discussing aspects and elements farmers abide by under the Animal Welfare Approved label). Under the Animal Welfare Approved Label, only farmers who own the animals themselves can qualify for use of the label. Id. The label set up standards for handling, transport and slaughter for all animals within the farms. For example, it is the only program that has an eight-hour maximum transport from farm to slaughter in the United States. Id. The label prohibits the use of electric prods in slaughter and also provides for humane slaughter for animals such as chickens, who are excluded under the Humane Slaughter Act. Id.
(68) Standards, ANIMAL WELFARE APPROVED, http://animalwelfareapproved.org/standards/ (last visited Apr. 20, 2015) (describing animal welfare standards on Animal Welfare Approved farms.) Animal Welfare Approved has strict standards that farmers must abide by in order to be able to use the label. Id. The idea behind the standards is that: "animals must be able to behave naturally and be in a state of physical and psychological well-being, and that the way we raise our animals, the nutritional quality of the food they produce, and the impact of the farming system on the environment are all intrinsically linked." Id. Furthermore, the label has specific standards for each animal. Id. For example, tail docking on pigs, dehorning of cattle, and beak trimming on chickens is prohibited under the label. Id.
(69) 7 C.F.R. [section] 205.236-240 (2015) (outlining all USDA certified organic standards regarding livestock care); National Organic Program, U.S. DEP'T OF ARGIC, http://www.ams.usda.gov/AMSv1.0/NOPOrganicStandards (last visited Apr. 20, 2015) (discussing standards under USDA certified organic label). Under the current USDA organic regulations, it states that:
The producer of an organic livestock operation must establish and maintain year-round livestock living conditions which accommodate the health and natural behavior of animals, including: Year-round access for all animals to the outdoors, shade, shelter, exercise areas, fresh air, clean water for drinking, and direct sunlight, suitable to the species, its stage of life, the climate, and the environment...
7 C.F.R. [section] 205.239(a)(1) (2015). See also Food labels Exposed, ANIMAL WELFARE APPROVED (2014), available at http://animalwelfareapproved.org/wp-content/uploads/2014/09/AWA~Food-Labels-Exposed-v10- ONLINE.pdf. (outlining various food labels and what each label signifies). There are more than 1,000 certified organic farmers raising livestock in the United States. Id.
(70) See The Facts About Farm Animal Welfare Standards, FARM SANCTUARY, available at http://www.upc-online.org/welfare/standards_booklet_FINAL.pdf. "Approximately two percent of egg-laying hens, two percent of dairy cows, and less than one percent of beef cattle, pigs, and meat birds are raised under organic conditions." Id.
(71) See Challenging Concentration of Controls in the American Meat Industry, supra note 20, at 2646 (discussing how most meat derived from factory farms); What is a Factory Farm? AM. SOC'Y FOR THE PREVENTION OF Cruelty OF Animals, https://www.aspca.org/fight-cruelty/farm-animalcruelty/what-factory-farm (last visited Feb. 20, 2015) (discussing factory farm conditions).
(72) Infra notes 76-78 (discussing USDA authority over meat inspection and safety); infra notes 109113 (discussing FDA's power regarding food safety).
(73) See U.S. CONST, art. I, [section] 1. "All legislative powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives." Id. Furthermore, it is Congress who must: " ... make all laws which shall be necessary and proper for carrying into execution the foregoing powers, and all other powers vested by this Constitution in the government of the United States, or in any department or officer thereof." U.S. CONST, art. I, [section]8.
(74) See infra notes 109-113 (describing FDA's authority under the FD&C Act).
(75) Federal Meat Inspection Act, 21 U.S.C. [section] 601-695 (2006) (granting USDA power to control safety and inspection of meat). Id. The statute grants the USDA authority to examine and inspect "all cattle, sheep, swine, goats, horses, mules, or other equines" and to make such inspections "... before [such animals may] be allowed to enter into any slaughtering, packing, meat-canning, rendering, or similar establishment, in which they are to be slaughtered and the meat and meat food products thereof are to be used in commerce ... " 21 U.S.C. [section] 603. See also Poultry Products Inspection Act ("PPLA"), 21 U.S.C. [section] 451-472 (2006). This gives the USDA authority to perform "... ante mortem inspection of poultry in each official establishment processing poultry or poultry products for commerce," in order to "prevent the entry into or flow or movement in commerce of ... any poultry product which is capable of use as human food and is adulterated." 21 U.S.C. [section] 455(a). See also Egg Products Inspection Act ("EPIA"), 21 U.S.C. [section] 1031-1056 (2006) (granting authority to the USDA to inspect eggs during processing operations).
(76) See Stathopoulos, supra note 8, at 435-36. The FMIA and the PPLA only "encompass regulation and inspection from the time period just before slaughter through the completion of the finished food product (to ensure that no food products that are unfit for human consumption enter the chain of interstate commerce)." Id. Furthermore, the Egg Products Inspection Act merely regulates the process of "egg products," "which means only food products that are made of eggs that have been removed from their shells, and does not extend to the conditions under which eggs are produced on the farm." Id. See also Perry and Brandt, supra note 22, at 120. The inability of the USDA to punish offenders for violating humane regulations is demonstrated as follows: "The USDA lacks the power to criminally charge--or even civilly fine--offending individuals and/or companies. Thus, the agency simply has no authority to specifically target and punish those responsible for violating its humane handling regulations. In response to even the most horrific animal cruelty, the USDA only has the authority to write up a citation, to which management need only respond with a plan for corrective action, or temporarily shut down the slaughter plant that employs the abusers, an action rarely taken by the agency. The USDA cannot require the suspension or termination of employees--no matter how egregiously or regularly they abuse animals." Id. See also Key Facts: Humane Slaughter; U.S. DEP'T OF AGRIC., http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact- sheets/production-and-inspection/key-facts-humane-slaughter/key-factshumane-slaughter (last visited Feb. 20, 2015) (providing background on the USDA's inspection methods at animal slaughter). See also Inspection for Food Safety: The Basics, U.S. DEP'T OF AGRIC., http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/foodsafety-fact-sheets/productionand -inspection/inspection-for-food-safety-the-basics/inspection-for-food-safety-basics (last visited Feb. 20. 2015) (describing USDA inspection approaches prior to slaughter).
(77) See STUART B. LEVY, M.D., THE ANTIBIOTIC PARADOX HOW THE MISUSE OF ANTIBIOTICS DESTROYS THEIR CURATIVE POWERS 172 (2nd ed. 2002). Levy discusses the connection between confinement and antibiotic distribution in animal feed: "the close-confinement practices of some large farm complexes set the stage for cross contamination with infectious diseases. This is presumably the reason why, in the raising of veal cattle, the milk fed to them is almost uniformly supplemented with tetracycline." Id. See also Critically Important Antimicrobials for Human Medicine, WORLD HEALTH ORG. (2011), http://apps.who.int/iris/bitstream/10665/77376/1/9789241504485_eng.pdf (discussing various medically important antibiotics for humans used in animal feed).
(78) See LEVY, supra note 77, at 39. British bacteriologist Alexander Fleming discovered the first true antibiotic, penicillin, in 1928. Id. Public use of penicillin to treat bacterial infections occurred in the 1940s and was available without a prescription. Id. at 10. It was not until the 1950s that penicillin required a prescription. Id. See generally Antibiotics and the Food Animal Industry, supra note 2 (summarizing history of use of antibiotics on farms).
(79) Antibiotics and the Food Animal Industry, supra note 2 (describing how antibiotics were initially used by farmers). See also Tavernise, supra note 4 (outlining FDA's newest 2012 report regarding antibiotic distribution).
(80) 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, infra note 115 (providing data demonstrating antibiotics sold in the United States' 2012 calendar year). See also David Hoffman & Emma Schwartz, Sharp Increase Seen in Sales of Antibiotics for Use in Farm Animals, FRONTLINE (Oct. 2, 2014, 6:10 PM), http://www.pbs.org/wgbh/pages/frontline/health-science-technology/trouble-with-antibiotics/sharp-increase-seen-in- sales-of-antibiotics-for-use-in-farm-animals/ (discussing sixteen percent increase of agricultural antibiotics sold between 2009 and 2012). See
also MARTIN J. BLASER, M.D., MISSING MICROBES: HOW THE OVERUSE OF ANTIBIOTICS IS FUELING OUR MODERN PLAGUES 82 (2014). The exact number of pounds of antibiotics sold is not ascertainable because the agricultural and pharmaceutical industries are defensive about their use. Id. Although in 2008 Congress required drug companies to tell FDA the amount of antibiotics they sold for use in agriculture, FDA did not require them to "provide a information on how the drugs are being administered, to which animals, and why." Id. See also Record-High Antibiotic Sales for Meat and Poultry Production, PEW CHARITABLE TRUSTS (Feb. 6, 2013), http://www.pewtrusts.org/en/about/news-room/news/2013/02/06/recordhigh-antibioticsales-for-meat-and-poultry-production. In 2011, 7.7 million pounds of drugs were proscribed and given to people, and 29.9 million pounds of antibiotics were administered to animals - 3.9 times greater than humans. Id.
(81) See Lessing, supra note 3, at 474. There are three main ways in which antibiotic resistance can be transferred from animals to humans: through food, the environment or direct contact with farm animals. Id. See also Alicia D. Anderson et al., Public Health Consequences of Use of Antimicrobial Agents in Food Animals in the United States, 9 MICROBIAL DRUG RESISTANCE 373, 377 (2003) (advocating a reduction of use of animal non-therapeutic antibiotics to reduce antibiotic resistance). See also Terence J. Centner, Regulating the Use of Non-Therapeutic Antibiotics in Food Animals, 21 Geo. INT'L ENVTL. L. Rev. 1, 6 (arguing the reduction in administration of antibiotics in animal feed would decrease antibiotic resistant bacteria). See also Understanding Concentrated Animal Feeding Operations, CTRS. FOR DISEASE CONTROL AND PREVENTION, supra note 19 (outlining aspects of CAFOs). See also Lauren Orrico, Note, A Proposed Multifaceted Approach to Combatting Antibiotic Resistance, 27 J.L. & HEALTH 259, 266-67 (2014) (discussing ways in which antibiotic resistance is transferred from animals to humans). See also Antibiotic Resistance 101: How Antibiotic Misuse Can Make You Sick, FOOD & WATER WATCH (2012), available at http://documents.foodandwaterwatch.org/doc/AntibioticResistance.pdf (discussing negative implications of sub-therapeutic dosing of antibiotics on farms). In large factory farming operations, manure lagoons and formed and fecal bacteria collect in these lagoons. Id. at 9. Many of the antibiotics given to livestock are excreted through their waste, which many be used as a fertilizer. Id. The fertilizer may be introduced to the local environment, causing antibiotic resistant infections in humans. Id.
(82) See Lessing, supra note 3, at 469 (discussing three main purposes factory farms use antibiotics).
(83) The Medical Impact of Antimicrobial Use in Food Animals, WORLD HEALTH ORG. (1997), available at http://whqlibdoc.who.int/hq/1997/WHO_EMC_ZOO_97.4-pdf. The report noted the dangers of sub-therapeutic low dosing of drugs: "low-level, long-term exposure to antimicrobials may have greater selective potential than short-term, full-dose therapeutic use." Id. at 5. Furthermore, the report found that all uses of antibiotics will lead to the selection of resistant forms of bacteria. Id. See also JOINT FAO/OIE/WHO EXPERT WORKSHOP ON NON-HUMAN ANTIMICROBIAL USAGE AND ANTIMICROBIAL RESISTANCE: SCIENTIFIC ASSESSMENT (2003), available at http://whqlibdoc.who.int/hq/2004/WHO_CDS_CPE_ZFK_2004.7.pdf?ua=l. The panel found that:
"[t]he foodborne route is the major transmission pathway for resistant bacteria and resistance genes from food animals to humans, but other routes of transmission exist," and that the "consequences of antimicrobial resistance are particularly severe when pathogens are resistant to antimicrobials critically important in humans." Id. at 1. See also U.S GOV'T ACCOUNTABILITY OFFICE, GAO 04-490, ANTIBIOTIC RESISTANCE: FEDERAL AGENCIES NEED TO BETTER FOCUS EFFORTS TO ADDRESS RISKS TO HUMANS FROM ANTIBIOTIC USE IN ANIMALS (Apr. 22, 2004), available at http://www.gao.gov/new.items/d04490.pdf (discussing studies exhibiting how antibiotic resistance is transmitted to humans from animals). See also GUIDANCE FOR INDUSTRY #209 THE JUDICIOUS USE OF MEDICALLY IMPORTANT ANTIMICROBIAL DRUGS IN FOOD-PRODUCING ANIMALS, FOOD & DRUG ADMIN. (2012), available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM2 16936.pdf (discussing relevant studies since 1970 regarding antibiotic resistance as a result of farm administration). See also Marshall & Levy, supra note 30, at 726 (discussing studies linking non-therapeutic use of antibiotics to antibiotic resistance in humans).
(84) BLASER, supra note 80, at 82. Farmers discovered that livestock could gain weight at a relatively low cost with antibiotics. Id. Animals gained more weight per unit of food that they consumed, also known as improved feed efficiency. Id. In turn, pharmaceutical companies realized that they would be able to make profits by selling large amounts of antibiotics to farm operations. Id. See also LEVY, supra note 77, at 149. Doses to increase animal weight are continually administered in much smaller doses than therapeutic doses. Id.
(85) See GUIDANCE FOR INDUSTRY # 213, supra note 10 (instructing drug companies to voluntarily withdraw antibiotics for growth promotion).
(86) See LEVY, supra note 77, at 155. Sub-therapeutic doses or disease prevention doses are higher than growth promotion doses. See id. See also Lessing, supra note 3, at 464 (discussing extensive use of drugs in animal feed leads to antibiotic resistant infections). See also O'Brien, supra note 27, at 412-13 (discussing sub-therapeutic uses of antibiotics allows for crowded and unsanitary conditions on factory farms).
(87) See Lessing, supra note 3, at 464 (describing how antibiotic administration results in resistant infections in humans); see supra note 77 and accompanying text (discussing the need for antibiotics to remedy animal disease prevalent on CAFOs).
(88) Letter from Michael D. Maves, M.D., M.B.A., Executive Vice President CEO, Am. Med. Ass'n, to Representative Louise Slaughter, U.S. House of Representatives (Apr. 9, 2009), available at http://www.keepantibioticsworking.com/new/KAWfiles/64_2_106530.pdf. See also Positions of Medical <& Scientific Organisations on Antibiotic Use in livestock Operations, NATURAL RES. DEF. COUNCIL (Feb. 2014), available at http://www.nrdc.org/food/files/saving-anitbiotics-medquotes-FS.pdf (describing positions of organizations regarding antibiotic distribution on farms). See also Report to the President on Combatting Antibiotic Resistance, EXEC. OFFICE OF THE PRESIDENT, PRESIDENT'S COUNCIL OF ADVISORS ON SCL AND TECH. (Sept. 2014), available at http://www.whitehouse.gov/sites/default/files/microsites/ostp/PCAST/pcast_carb_report_sept2014.pdf (discussing report to the President regarding extensive use of antibiotics in agriculture).
(89) See BLASER, supra note 80, at 826 (discussing consumption of meat and dairy products leads to antibiotics resistance). See also GAO 04-490, supra note 83, at 1-2 (explaining the development of antibiotic resistance).
(90) BLASER, supra note 80, at 80 (stating ways in which humans may develop resistance to drugs). See also Joseph Mercola, FDA Fails to Protect Against Antibiotic Resistance, Guarantees More Needless Death and Suffering, MERCOLA.COM, http://articles.mercola.com/sites/articles/archive/2014/04/23/agricultural-antibiotic-overuse.aspx (last visited Feb. 20, 2015) (finding eighty different antibiotics are allowed in cows' milk).
(91) See 7 C.F.R. [section] 205.237 (2015). "The producer of an organic operation must not: use animal drugs, including hormones, to promote growth." [section] 205.237(b)(1). The producer must also not "provide feed or forage to which any antibiotic including ionophores has been added." [section] 205.237(b)(7). See also A Consumer's Guide to Food labels and Animal Welfare, ANIMAL WELFARE INSTIT., https://awionline.org/consumers-guide-food-labels-and-animal-welfare (last visited Apr. 20, 2015). The USDA does permit labeling such as "no antibiotics administered," "no antibiotics added," and "raised without antibiotics" only if the producer can show documentation that the animals have not received antibiotics at any point in their lives for any purpose, including treatment of illness. Id. Labels such as "antibiotic free" are illegal because antibiotic-residue testing technology is unable to confirm that an animal has never received antibiotics. Id.
(92) See supra notes 69-70 and accompanying text (discussing how many products are actually derived from animals from organic farms).
(93) BLASER, supra note 80, at 85. "A child who drinks two cups of milk a day will ingest about 50 micrograms of tetracycline every day." Id. Although, "this is not a lot, but consider the fact that many children drink milk every day, year after year." Id.
(95) See How Antibiotic Resistance Happens, PEW CHARITABLE TRUSTS, http://www.psr.org/chapters/Oregon/healthy-food-in -health-care/121313-food-matters-training/pew-how-resistance-happens.pdf (last visited Apr. 20, 2015). The way in which humans can contract resistant bacteria are described as follows:
Food animals can shed resistant bacteria in their feces, or on skin in the case of Staphylococcus infections. Once there, antibiotic-resistant bacteria in contaminated manure can migrate around a farm, in slaughter and meat processing, into neighboring farms and the environment, and even across long distances. Therefore, once harmful resistant bacteria are generated, they are hard to control.
Id. Improperly handling meat or consuming uncooked contaminated meat exposes humans to antibiotic resistant bacteria. Id. See also LEVY, supra note 77, at 71. Levy puts the issue in perspective:
[t]oday most infectious-disease causing bacteria that were previously universally susceptible to antibiotics are resistant to at least some antibiotics and, in many instances, to a large number of drugs. We must face this unsettling situation now, only 100 years since the recognition that bacteria cause disease and only 60 years since the discovery of antibiotics.
Id. See also GAO 04-490, supra note 83, at 1 -2 (outlining spread of antibiotic resistance and its transference from animals to humans). See generally LEVY, supra note 77, at 57. Antibiotic resistance is also attributed to humans misusing antibiotics by ingesting drugs not necessary or when they are prescribed inappropriately by doctors. Id. See generally Stop the Spread of Superbugs, NEWS IN Health (Feb. 2014), http://newsinhealth.nih.gov/issue/feb2014/featurel (discussing issues surrounding the spread of antibiotic resistant bacteria). "Superbugs are strains of bacteria that are resistant to several types of antibiotics." Id.
(96) See LEVY, supra note 77, at 155. Farm animals' bacteria on their skin and in their intestines are resistant to many types of antibiotics. Id. Because food animals are "chronically and routinely" administered antibiotics, the "microorganisms that they harbor are often multiply resistant, a situation that produces a health hazard to the human population." Id. at 170.
(97) See id. at 71. Reliance on antibiotics led to an unexpected resistance to bacteria, which found ways to resist the drugs. Id. "Since food animals are routinely and chronically being fed antibiotics, the microorganisms that they harbor are often multiply resistance, a situation that produces an additional health hazard to the human population." Id. at 170. See also Antibiotic Resistance Threats in the United States, CTR. FOR DISEASE CONTROL AND PREVENTION (2013), available at http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=13 (displaying link between humans and animals). Drug resistant bacteria can remain on meat from animals and when not properly cooked or handled, the bacteria spreads to humans. Id. See also Super Bugs Turking in your Dinner? FOOD & WATER WATCH (July 11, 2012), http://www.foodandwaterwatch.org/blogs/super-bugs-lurking-in-your-dinner/ (describing how "super bugs" have evolved); supra notes 1, 3 and accompanying text (discussing antibiotic resistance bacteria and threat to human health). See generally Stop the Spread of Superbugs, supra note 95. Many superbugs or antibiotic resistant infections occur in health care settings because patients possess a weakened immune system and are more susceptible from contracting an infection. Id.
(98) See The National Antimicrobial Resistance Monitoring System (NARMS) Strategic Rian 2012-2016, DEP'T OF HEALTH AND HUMAN SERV., available at http://www.fda.gov/downloads/Animalystem/UCM236283.pdf (describing NARMS mission and plan to research antibiotic resistance transferred to humans from animals). NARMS was established in 1996 and its mission is to monitor the "susceptibility of enteric bacteria to antimicrobial agents of medical importance in order to help assess the impact of veterinary antimicrobial use on human health." Id. at 2. NARMS also conducts research to "better understand the emergence, persistence, and spread of antimicrobial resistance" while providing data to the FDA in order to assist the Agency in making decisions regarding approval of safe and effective antibiotics for animals. Id. at 3. One of the systems main objectives according to NARMS' plan is to "improve the geographic representativeness of retail meat testing and increase the number of retail meat isolates recovered in order to better assess trends." Id. at 5.
(99) See infra note 100 and accompanying text (discussing high levels of bacteria found on retail meats).
(100) See, e.g., 2011 Retail Meat Report, FOOD & DRUG ADMIN. (2011), available at http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/Nati onalAntimicrobialResistanceMonitoringSystem/UCM334834.pdf (reporting data and trends of certain antibiotic resistant bacteria such as E-coli, Salmonella, Campylobacter). According to the study's findings:
[e]-coli isolated from 37.5 percent of chicken breasts samples and 64.4 percent of ground turkey samples were resistant to at least three antimicrobial classes. Similarly, 43.3 percent of Salmonella isolates from chicken breast, 33.7 percent of ground turkey isolates, 42.9 percent of ground beef isolates, and 50 percent of pork chop isolates were resistant to three or more classes.
Id. Industrial Food Animal Production, infra note 153 (discussing results of 2011 NARMS retail meat report). See also Levy, supra note 77, at 167-80. The most infectious bacteria is Salmonella, followed by Campylobacter which both cause severe diarrhea in humans. Id. at 167. See also Lessing supra note 3, at 475 (discussing process by which antibiotic resistant infections are transferred to humans from animals). See also Stephanie Strom, Report of U.S. Meat Sound Alarm on Resistant Bacteria, N.Y. TIMES (Apr. 16, 2013), http://www.nytimes.com/2013/04/17/business/report-on-us-meat-sounds-alarm-on-superbugs.html?_r=l& (reporting increase in amount of antibiotic resistant bacteria found on meat).
(101) See HAUTER, supra note 20, at 140-42. The largest contaminated recall to date was commenced by Cargill, one of the largest turkey--producing corporation. Id. at 140. In twenty-six states, 36 million pounds of contaminated turkey with a strain of Salmonella resistant to many antibiotics caused illnesses in many people. Id. This bacteria or super bug was traced back to a single plant in Arkansas. Id. This specific bacteria is mainly carried by poultry and has been found to be resistant to a very powerful and important antibiotic, Cipro. Id. See also Antibiotic Resistance Threats in the United States, supra note 97, at 16. "The total economic cost of antibiotic resistance to the U.S. economy has been difficult to calculate. Estimates vary but have ranged as high as $20 billion in excess direct healthcare costs, with additional costs to society for lost productivity as high as $35 billion a year." Id. at 11. See also Coilin Nunan & Richard Young, Antibiotic Resistance--The Impact of Intensive Farming on Human Health, SOIL ASS'N (Mar. 2013), http://www.soilassociation.org/LinkClick.aspx?fileticket=_fGgt7a0eeE%3D&tabid=1841. "For some serious live-threatening infections such as E. coli, no new antibiotics are currently close to development, and treatment failures are already occurring." Id. at 3. Today, many antibiotic resistant infections still respond to antibiotics, however when infections are resistant to the antibiotics usually used to treat the bacteria, lengthy hospital stays occur, and patient recovery is slower. Id. Costs to health services and taxpayers increase greatly. Id. In some instances, doctors might have to proscribe more toxic antibiotics that cause serious side effects and developing new antibiotics is difficult and expensive. Id. Thus, antibiotic resistance is developing faster than new antibiotics are being developed. See id. See also Tackling Antibiotic Resistance From a Food Safety Perspective in Europe, WORLD HEALTH ORG. (2011), available at http://www.euro.who.int/_data/assets/pdf_file/0005/136454/e94889.pdf. "Antibiotic resistance in Salmonella has been associated with more frequent and longer hospitalization, longer illness, a higher risk of invasive infection and a twofold increase in the risk of death in the two years after infection." Id. at 18. See also Elizabeth Weise, New Salmonella Outbreak in Chicken Resists Antibiotics, USA TODAY (Oct. 8, 2013), http://www.usatoday.eom/story/news/nation/2013/10/08/salmonella-chickenoutbreak/2941783/. In 2013, a California Salmonella outbreak that involved several antibiotic resistant strains of the disease placed at least 42 percent of the victims in the hospital. Id. Thirteen percent of those victims contracted salmonella septicemia, which is a serious life-threatening entire body inflammation. Id. See also Katie Moisse, Antibiotic Resistance: The 5 Riskiest Superbugs, ABC NEWS (Mar. 27, 2012), http://abcnews.go.com/Health/Wellness/antibioticresistance-riskiest-superbugs/story?id=15980356#.T_xrPHDR0gQ (describing most harmful bacteria resistant diseases and how each is spread).
(102) See Human Health Risks with the Subtherapeutic Use of Penicillin or Tetracyclines in Animal Feed, INST. OF MED. (1988), available at http://www.fda.gov/ohrms/dockets/dailys/03/Aug03/081403/03n-0324-bkg0001-05-tab-4-01- vol2.pdf (finding indirect evidence that both drugs administered sub-therapeutically posed health hazard for humans). See also GUIDANCE FOR INDUSTRY #209, supra note 83, at 20-22 (recommending new FDA plan to phase out growth promotion uses); Lessing, supra note 3, at 474 (stating tetracyclines and penicillin are still used on factory farms extensively today); Playing Chicken with Antibiotics, NATURAL RES. DEE. COUNCIL, http://www.nrdc.org/ food/saving-antibiotics/antibiotic-feed-fda-documents.asp (last visited Apr. 21, 2015) (criticizing FDA for allowing use of certain antibiotics in animal feed). Tetracyclines and Penicillin make up almost half of the antibiotics that are administered in animal feed. Id. See generally LEVY, supra note 77. Penicillin was called the miracle drug due to its "unique and rapid control of infectious bacteria." Id. at 7. "Small amounts of the drug cured blood-bourne infections, pneumonias, and open skin wounds." Id. The wide success of penicillin motivated scientists to find new antibiotics that could treat other diseases, including penicillin resistant strains of bacteria. Id. at 11. Tetracyclines first introduced in 1948 exhibited low toxicity and a "broad spectrum" of activity against bacteria. Id. at 49. "Today tetracyclines rank only second to penicillin in world production and use." Id at 50.
(103) See Tackling Antibiotic Resistance From a Food Safety Perspective in Europe, supra note 101, at 2. See also BLASER, supra note 80, at 6. Today, even lethal diseases, such as tuberculosis, are reappearing and have increasingly become resistant to antibiotics. Id. Farmers give animal the same drugs that people get from their doctors giving contributing to antibiotic resistance. Id. at 83.
In 2013, Consumers Union tested hog carcasses and found that 13 of 14 Staphylococcus samples isolated from pork were resistant to at least one antibiotic. So were 6 of 8 Salmonella samples....[o]ne sample was found to have MRSA, the fearsome drug-resistant and sometimes fatal form of staph.
Id. Blaser confronts the question: "Why would we squander our precious antibiotics, including the ones that save lives when nothing else helps, to make meat a few cents a pound less expensive?" Id. See also HAUTER, supra note 20, at 142. Other resistant bacterial infections, such as Methicillin-resistant Staphylococcus Aureus ("MRSA"), are killing almost 18,000 Americans each year, and are likely linked to the use of sub-therapeutic doses in animal feed. Id. MRSA does not respond to antibiotics commonly used to treat the disease and is now becoming a disease contracted outside the hospital setting. Id. See also Anita Slomski, South Africa Warns of Emergence of "Totally" Drug-Resistant Tuberculosis, 309 Am. Med. ASS'N 1097 (2013) (discussing emergence of antibiotic resistant forms of tuberculosis). See also LEVY, supra note 77, at 13. Many sick patients in hospitals today are dying form diseases that were predicted 50 years ago to be gone. Id. The constant and continued use of antibiotics led to more resistant strains to the drugs. See id. See also Moisse, supra note 101 (reporting types of antibiotic resistant infections in humans). See also Will S. Hylton, A Bug in the System, The NEW YORKER (Feb. 2, 2015), http://www.newyorker.com/magazine/2015/02/02/bug-system (chronicling human story of a strain of antibiotic resistance salmonella).
(104) See Challenging Concentration of Control in the American Meat Industry, supra note 20, at 2645. Lawmakers and regulators did not address the transformation to new conditions and technologies on farms. Id. See also Toward a Humane, Equitable, and Sustainable Food System in The Cafo Reader: The Tragedy of Industrial Animal Factories 297 (Daniel Imhoff ed., 2010) (arguing full enforcement of existing regulations is overdue). See also Nathan M. Trexler, "Market" Regulation: Confronting Industrial Agriculture's Food Safety Failures, 17 WIDENER L. REV. 311, 316 (2011) (discussing food safety and law's inability to keep up with industrialized food system).
(105) Pure Food and Drug Act of 1906, Pub. L. No. 59-384, ch. 3915, 34 Stat. 768 (1906) (repealed 1938). "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes." Id. In the early 1900s, the Pure Food and Drug Act ("PFDA") was passed to address health issues arising from conditions in meat-packing plants. See generally HAUTER, supra note 20, at 136. PFDA was intended to prevent dishonest companies from selling mislabeled products. Id. However, today most of our food is processed, unlike in the early twentieth century where food was prepared "from scratch" at home, and most food came from local and regional sources. Id. See generally Trexler, supra note 104, at 317. Congress repealed the PFDA when it passed the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibited the interstate transport of adulterated food. Id. Concern for meat safety dates back to the early 1900s when Upton Sinclair's publication of The Jungle revealed filthy and unsanitary conditions of meat-packing factories. Id. at 316. See generally Upton Sinclair, The JUNGLE (Paul Negri & Joslyn T. Pine eds., 2001) (1906) (revealing horrors of meat-packing plant conditions).
(106) Pub. L. No. 59-384, ch. 3915, 34 Stat. 768 (describing authority to regulate foods except meat, poultry, and eggs).
(107) Food, Drug and Cosmetic Act, 21 U.S.C. [section][section] 301-379 (1938). Pursuant to the FD&C Act, FDA has the authority to, and does already regulate, most of the contents of animal feed and the drugs that may be administered to farmed animals. See generally HAUTER, supra note 20, at 140 (providing brief history of FD&C Act).
(108) 21 U.S.C. [section] 354. Public Health Service Act, 42 U.S.C. [section][section] 201-300ff-72 (2006) (outlining FDA statutory authority from PHSA). See also Animal Health and Consumer Protection, FOOD & DRUG ADMIN. (2006), http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/AnimalHealthandConsumerProtection/. "Animal feed and drugs have been regulated for as long as human food and drugs. When Congress passed the Pure Food and Drug Act in 1906, it introduced the regulation of food and drugs in interstate commerce for 'man or other animals.'" Id. However, FDA had very limited power under the PFDA. Id. When the FD&C Act was passed in 1938, FDA was granted more regulatory control and power by requiring manufacturers to show that their products were safe before being sold. Id.
(109) 21 U.S.C. [section] 331(a). See also DANIEL CARPENTER, REPUTATION AND POWER: Organizational Image and Pharmaceutical Regulation at the FDA 16 (describing FDA's power with regard to regulation of drugs). See also Animal Health and Consumer Protection, supra note (108). "The FDA's Center for Veterinary Medicine ("CVM") is responsible for regulating drugs and food additives used for animals--both food-producing animals and family pets." Id. See generally Food Safety Modernization Act, 21 U.S.C. [section][section] 111-353 (2011) (expanding FDA inspection and recall power).
(110) 21 U.S.C. [section] 342(a)(1) (regulating animal antibiotics); 21 U.S.C. [section] 360(b)(a)(l) (explaining FDA power to regulate new animal drugs); Fourth Draft: Framework of the FDA Animal Feed Safety System, FOOD & Drug Admin., http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalFeedSafetySystemAFSS/ucml96795.htm#Component_A (last visited Apr. 20, 2015) (outlining FDA's control and power to regulate animal feed contents). 21 U.S.C. [section] 393 (b)(1)(B) (describing FDA's mission to ensure "human and veterinary' drugs are safe and effective").
(111) See 21 C.F.R. [section] 514 (outlining FDA approval process for new animal drug applications). In order to be approved for use, applications for the new animal drug must be submitted by the applicants to the CVM along with all relevant information such as laboratory studies, clinical studies, and conclusions concerning the effectiveness and safety of the drugs. 21 C.F.R. [section] 514.1. See also From an Idea to Marketplace: The journey of an Animal Drug through the Approval Process, FOOD & DRUG Admin., http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm219207.htm#A_Brief_Summary_of_the_Drug_Appr oval _Process (last visited Feb. 22, 2015) (providing overview of FDA drug approval of animal drugs). First, the drug sponsor will collect information about the safety and effectiveness of the drugs and the drug sponsor will submit the application along with all studies and the proposed label to CVM. Id. Subsequently, a CVM team will review the new animal drug application ("NADA") and if the drug is determined to be safe and effective used according to the label proposed by the applicant, the NADA is approved and the drug can be sold legally. Id. See also Meghan F. Davis & Lainie Rutkow, Regulatory Strategies To Combat Antimicrobial Resistance of Animal Origin: Recommendations for a ScienceRased U.S. Approach, 25 Tul. Envtl. L.J. 327, 343-44 (outlining history' of FDA and approval of antibiotics in feed).
(112) See HAUTER, supra note 20, at 144 (discussing controversy over use of tetracyclines and penicillin in animal feed today). See also supra note 102 and accompanying text (discussing importance of tetracyclines and penicillin for humans).
(113) Withdrawal of Notices of Opportunity for a Hearing; Penicillin and Tetracycline Used in Animal Feed, 76 Fed. Reg. 246,79697-79701 (Dec. 22, 2011). FDA is "withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns." Id.; Greg Cima, FDA Cancels 1977 Drug Withdrawal Bids, Am. VETERINARY Med. ASS'N (Feb. 1, 2012), https://www.avma.org/News/JAVMANews/Pages/120215f.aspx (discussing FDA's withdrawal of notice of opportunity hearings connected with 1977 proposals.
(114) See GUIDANCE for Industry #213, supra note 10 (outlining FDA's newest plan to attempt to curb antibiotic resistance); GUIDANCE FOR INDUSTRY #209, supra note 83 (stating FDA's initial plans to commence the voluntary withdraw of drugs for growth enhancement). See also Guidance for Industry #152 Evaluating the. Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, Food & Drlig Admin. (2003), available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052519.pdf. This guidance was intended to "[discuss] a recommended approach for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern." Id.
(115) See LEVY, supra note 77, at 155. See also 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, FOOD & DRUG ADMIN. (2014), http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM416983.pdf (analyzing sales and distributions of medically important drugs in animal feed).
(116) See LEVY, supra note 77, at 155 (explaining how doses for growth promotion require much higher dosages similar to therapeutic purposes); Krans, infra note 125 (criticizing FDA guidance for only opposing growth promotion use).
(117) See GUIDANCE FOR industry # 213, supra note 10, at 3-4 (requesting that pharmaceutical companies re-label drugs not to include growth promotion purposes). See also Phasing Out Certain Antibiotic Use in Farm Animals, FOOD & Drug Admin., http://www.fda.gov/forconsumers/consumerupdates/ucm378100.htm (last visited Feb. 23, 2015). Antibiotics in animal feed "have long been FDA-approved for production (e.g., growth enhancement) purposes as well as for the treatment, control or prevention of animal diseases." Id. "[I]t is not entirely understood how these drugs make animals grow faster. The drugs are primarily added to feed, although they are sometimes added to the animals' drinking water." Id.
(118) Phasing Out Certain Antibiotic Use in Farm Animals, supra note 117 (focusing on eliminating certain uses of antibiotics to diminish antibiotic resistance). See also GUIDANCE FOR INDSUTRY # 209, supra note 83 (commencing plans to phase out growth promotion use of antibiotics on farms).
(119) See GUIDANCE FOR INDUSTRY # 213, supra note 10, at 4, 9 (describing FDA's scheme to phase out growth uses over three years). See also HAUTER, supra note 20, at 145 (describing FDA's 2012 guidance and plan to promote "judicious use" of antibiotics). See also Tomaselli, infra note 127 (describing FDA's voluntary efforts as "half measures").
(120) See GUIDANCE FOR Industry # 213, supra note 10, at 4. The most recent guidance states: "FDA believes that production use indications such as 'increased rate of weight gain' or 'improved feed efficiency' are no longer appropriate for the approved conditions of use for medically important antimicrobial drugs." Id. See also Phasing Out Certain Antibiotic Use in Farm Animals, supra note 117 (describing FDA's objectives under its newest guidance for industry). See also Margaret A. Hamburg, M.D., FDA's Fake on the Executive Order and National Strategy to Combat Antibiotic-Resistant Bacteria (Sept. 18, 2014), http://blogs.fda.gov/fdavoice/index.php/2014/09/fdas-take-on-the-executive-order-and-national-strategy-to-combat -antibiotic-resistantbacteria/#sthash.B19QQCm8.dpufn (describing FDA's new voluntary plan phasing out some antibiotics use in feed from FDA Commissioner).
(121) GUIDANCE FOR Industry #213, supra note 10, at 4. The guidance lays out a voluntary framework with two main principals: "(1) Limit medically important antimicrobial drugs to uses in animals that are considered necessary' for assuring animal health, and (2) Limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation." Id.
(122) Id. "The purpose of this guidance is to provide sponsors with specific recommendations on how to voluntarily modify the use conditions of their medically important antimicrobial drug products to align with the above two principles." Id. FDA considers uses that are associated with the treatment, control, and prevention of specific diseases for therapeutic uses that are necessary for assuring the health of food-producing animals. Id.
(123) PDA's Strategy on Antimicrobial Resistance - Questions and Answers, FOOD & DRUG ADMIN., http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/Guidanceforlndustry/ucm216939.htm#question5 (last visited Feb. 22, 2015) (explaining voluntary approach and how it will be implemented). FDA Takes Significant Steps to Address Antimicrobial Resistance, FOOD & DRUG Admin. (Dec. 11, 2013), http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm378166.htm. "The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight." Id. GUIDANCE FOR Industry #213, supra note 10. Prior to 1993, most antibiotics were approved for over-the-counter use in livestock administered in feed or water. Id. at 6.
(124) GUIDANCE for Industry #213, supra note 10 (describing FDA's proposal to re-label drugs solely for disease prevention and therapeutic purposes).
(125) See FDA Takes Significant Steps to Address Antimicrobial Resistance, supra note 123. FDA requests that, "pharmaceutical companies voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications." Id. GUIDANCE FOR INDUSTRY #213, supra note 10 (outlining recommendations to pharmaceutical industry); FDA's Strategy on Antimicrobial Resistance, supra note 123 (discussing FDA's strategy and objectives regarding industry guidance). FDA defines the factors that veterinarians will use when proscribing drugs for therapeutic and disease prevention purposes:
(1) there is evidence that the drug will be effective in treating the particular disease, (2) such preventive use is consistent with accepted veterinary practice,
(3) the use is intended to address particular bacteria, (4) the use is appropriately targeted to animals at risk of developing a specific disease, and (5) there are no reasonable alternatives for intervention.
GUIDANCE FOR INDUSTRY #213, supra, at 7. See also Greg Cima, Changes Coming in Antimicrobial Use, Availability, Am. VETERINARY MED. ASS'N (Dec. 17, 2014), https://www.avma.org/News/JAVMANews/Pages/150101n.aspx (discussing theory behind FDA's new guidance regarding veterinary oversight of medically important drugs). Rut see Brian Krans, An Epidemic 37 Years in the Making, HEALTHLINE, http://www.healthline.com/health/antibiotics/epidemic-overuse (last visited Jan. 29, 2015) (explaining possible implications of FDA's Guidance #213). It has been determined that many of the doses and durations of antibiotic use for disease prevention or subtherapeutic use are similar or almost the same as the doses administered in animal feed for production, growth, and efficiency purposes. Id. Krans suggests that under Guidance #213 antibiotic use may not change, even if antibiotics are not technically used for growth purposes anymore and are under veterinary supervision. See id. But see 'The Medical Impact of Antimicrobial Use in Food Animals, supra note 83 (highlighting various drugs contributing to specific antibiotic resistant infections); LEVY, supra note 77, at 175. During a World Health Organization meeting in October 1997 in Berlin, Germany, data was presented on the concerning issues "posed by antibiotics used for only animals, which were not obvious human therapeutics at the time they were first implemented. Id. For example, avoparcin and virginiamycin, considered 'animal-only' antibiotics, could select strains resistant to drugs recently approved for humans." Id. The attendees at the meeting agreed that any use of antibiotics in animals could impact human health in the future. Id. But see Industrial Food Animal Production, infra note 153, at 9. "Changes to the VFD requirements could weaken significantly the meaning and value" of veterinary oversight. Id. See generally Animal Medicinal Drug Use Clarification Act ("AMDUCA") of 1994, 21 U.S.C. [section] 360(a) (permitting veterinarians to prescribe antibiotics inconsistent with the approved labeling); 21 C.F.R. [section][section] 530.20-530.21 (2015) (outlining appropriate scenarios and situations to permit or deny extra-label use in livestock). See generally 21 C.F.R. 530.21(a)(2) (2015). FDA may prohibit extra-label use of a new approved animal or human drug in food-producing animals if the Agency determines that the extra label use poses a risk to public health. Id. See generally GUIDANCE FOR INDUSTRY #213, supra, at 4. In FDA's view, in order to implement their recent guidance, it is important to facilitate the over the counter to labeling drugs as "veterinary feed directive" (VFD) drugs. Id. See generally 21 C.F.R. [section] 558.3(b)(6) (providing definition of VFDs). A VFD is an approved new animal drug intended for use in animal feed and is required to be administered under the supervision of a veterinarian. Id.; GUIDANCE FOR INDUSTRY #120, VETERINARY FEED DIRECTIVE REGULATION, FOOD & DRUG ADMIN. (2009), available at http http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052660.pdf (explaining purpose and use of VFDs); 21 C.F.R. 558.6(a)(xii) (2015) (outlining conditions veterinarians must meet when issuing a VFD). Extra-label use is strictly prohibited under a VFD. Id. See generally Veterinary Feed Directive, 78 Fed. Reg.75515 (proposed Dec. 12, 2013) (promoting FDA's goals outlined in their guidance, regarding revisions to VFD regulations); GUIDANCE FOR Industry #213, supra at 8. "Some of the key changes being considered include better alignment between the criteria for appropriate veterinary supervision or oversight and those established as part of veterinary' licensing and practice requirements and streamlining administrative procedures." Id.
(126) See Krans, supra note 125 (examining FDA's problematic approach to phasing out antibiotic use).
(127) See Paige Michele Tomaselli, Symposium: Ethical Implications of the Commercial Use of Animals: Paving the Way: Are Half Measures in Animal Factory Farm Legislation Ethical?, 54 S. TEX. L. REV. 513, 527 (2013) (criticizing the FDA's voluntary strategy' to combat antibiotic resistance because they amount to "half measures").
(128) See Zuraw, infra note 131. Zuraw reports that drug manufacturing companies do not foresee a change in the amount of drugs distributed for animal production purposes or growth enhancement purposes under the FDA's new guidance. Id. Further, she argues that sub-therapeutic distributions will still be prevalent and widely distributed. Id.
(129) GUIDANCE for Industry #213, supra note 10. The FDA believes that the judicious use of medically important antimicrobial drugs intended for use in food-producing animals should involve the scientific and clinical training of a licensed veterinarian. Id. at 6-7. This is because judicious use involves accurately identifying bacterial disease that is present or likely to be present and selecting the suitable antimicrobial drug. Id. at 7. See also 21 C.F.R. [section] 530.41 (prohibiting certain antibiotics for extra-label use). See also FDA's Strategy on Antimicrobial Resistance, supra note 123. Under FDA's guidance, veterinarians are directed to proscribe specific antibiotics, aimed at curing a specific illness the animal is suffering from. Id. See generally Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), FOOD & DRUG ADMIN., http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/ucm085377.htm (last visited Feb. 22, 2015) (discussing extra-label use); 21 C.F.R. [section] 530.3(a) (defining extra-label use). "Extralabel use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions." Id.
(130) GUIDANCE FOR INDUSTRY #213, supra note 10, at 5. "FDA believes a voluntary approach, conducted in a cooperative and timely manner, is the most effective approach to achieve the common goal of more judicious use of medically important antimicrobials in animal agriculture." Id. FDA Update on Animal Pharmaceutical Industry Response to Guidance #213, FOOD & DRUG ADMIN., http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/Judicio usUseofAntimicrobials/ucm390738.htm (last visited Feb. 22. 2015). The twenty five affected drug sponsors who complied in writing by March 2014 held 99.6 of the applications affected by Guidance #213. Id.
(131) Lydia Zuraw, Antibiotic Reduction Advocates Target Growth Promotion Marketing loophole, FOOD SAFETY News (May 22, 2014), http://www.foodsafetynews.com/2014/05/antibiotic-advocatestarget-growth-promotion-marketing-loophole/#.VH87_IvIb0s (explaining possible loopholes to circumvent FDA's newest guidance).
(133) See FDA Secures Full Industry Engagement on Antimicrobial Resistance Strategy, Food & Drug Admin. (June 30, 2014), http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm403285.htm (announcing that FDA received full industry compliance with newest guidance).
(134) Gaps in FDA's Antibiotics Policy: Many Drugs May Still be Available for Food Animals at Growth Promotion levels, PEW CHARITABLE Trusts (Nov. 2014), available at http://www.pewtmsts.org/~/media/Assets/2014/11/HHIF_FDA213Gaps_v4.pdf (analysis of FDA drugs affected by guidance and discussing flaws in FDA's Guidance #213). See also FDA Update on Animal Pharmaceutical Industry Response to Guidance # 213, FOOD & DRUG ADMIN., http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofA ntimicrobials/ucm390738.htm (last updated Mar. 26, 2014) (providing update regarding industry compliance with guidance). On December 11, 2013, FDA identified a total of twenty seven drug sponsors with a total of 287 drug products. Id. Since this date, FDA has revised these numbers. Id. Currently, there are twenty six drug sponsors with a total of 283 affected drug applications. Id. See also List of Affected Applications, FOOD & DRUG Admin., http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobiaIs/ucm390429.htm (last updated Dec. 19, 2014) (providing list of drugs and drug sponsors affected by FDA Guidance 213). See also LEVY, supra note 77, at 155. The constant use of low-dose growth promotion hormones into animal feed has shown as diminished effect on farm animals today. Id. Today, low-dose growth promotion distribution into animal feed has almost reached the levels needed for prevention dosage. See id. For instance, to increase growth, "in the 1950s, 5-10 parts per million of tetracycline were effective; today fifty to two-hundred parts per million are needed." Id.
(135) Gaps in FDA's Antibiotics Policy, supra note 134 (discussing fallacies with FDA's new guidance based on analysis).
(136) Gaps in FDA's Antibiotics Policy, supra note 134 (suggesting that FDA is unable to distinguish between how growth enhancement and prevention are used). Rut see Report to the President on Combatting Antibiotic Resistance, supra note 88, at 54. "... some have expressed concern that the FDA guidances are insufficient because current antibiotic usage intended for growth promotion might be redesignated as intended for disease prevention. We note, however, that such redesignation by veterinarians would be unethical and illegal." Id.
(137) See id.; Summary of PCAST's Report on Combating Antibiotic Resistance, PEW CHARITABLE TRUSTS (Sept. 25, 2014), http://www.pewtrusts.org/en/about/news-room/news/2014/09/25/summary-of-pcasts-report-on-combating-antibiotic-resistance (outlining report and analysis of FDA's Guidance #213).
(138) Summary of PCAST's Report on Combating Antibiotic Resistance, supra note 137 (summarizing report to the President regarding antibiotic resistance transferred from animals); Gaps in FDA's Antibiotics Policy, supra note 134 (discussing ambiguous labeling of disease prevention antibiotics).
(139) Natural Res. Def. Council, Inc. v. U.S. Food and Drug Admin., 884 F.Supp.2d 127 (2012) (requiring FDA follow through with withdrawal hearings based on initial findings). See Food and Drug Administration's Regulation of Antibiotics Used in Animal Feeds (1977), available at http://www.gao.gov/assets/100/98536.pdf. The report found:
[t]he feeding of certain antibiotics to animals has led to the development of antibiotic-resistant bacteria in food animals that may be transmitted to humans. The continuous feeding of certain antibiotics to animals has been reported to compromise the treatment of certain animal diseases. Limiting the types of antibiotics used in animal feeds is a step toward controlling the resistance problem. The safety and efficacy of long-term subtherapeutic feeding of antibiotics for disease prevention and control have not been adequately demonstrated.
Id. at 3-4. Furthermore, the report urged that penicillin be discontinued in animal feed for growth promotion and tetracyclines withdrawn where effective substitutes were available. Id.
(140) Natural Res. Def. Council, Inc. v. U.S. Food and Drug Admin., 760 F.3d 151, 171-72 (2nd Cir. 2014). See also HAUTER, supra note 20, at 144 (describing FDA under pressure to act on their 1977 proposal). See also Erin Durkin, Appeals Court Overturns Mandate Requiring FDA Action On Animal Antibiotics, INSIDE HEALTH REFORM (July 30, 2014), http://iwpnews.com/IWPGeneral/Inside-Washington-Publishers-Health/insidehealthpolicycom/menu-id-848.html (discussing court's decision to reverse mandate requiring FDA to withdraw drugs).
(141) NRDC, Inc., 760 F.3d at 157-58. See also Penicillin, 42 Fed. Reg. at 43,792 (notice of opportunity of hearing to propose withdrawing approval for new animal penicillin drug applications); Tetracycline, 42 Fed. Reg. at 56, 288 (notice of opportunity of hearing to propose withdrawing approval for new animal tetracycline drug applications).
(142) NRDC, Inc., 760 F.3d at 171-72.
(143) Id. at 192. Furthermore, the dissenting judge interpreted FDA's duty under the FD&C Act requiring "the FDA to pursue formal withdrawal proceedings whenever it makes a preliminary finding that an animal drug is not shown to be safe for its approved use." Id. at 193. See also 21 U.S.C. [section] 360b(e)(l)(B) (2008). The statute states:
[t]he Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) with respect to any new animal drug if the Secretary finds--that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (I) of paragraph (1) of subsection (d) applies to such drug.
(144) See NRDC, he., 760 F.3d at 160-61 (describing FDA withdrawal process). The court describes the hearing process:
[t]he hearing process is thus a critical precondition of the withdrawal order, and as plaintiffs concede, the entire purpose of the hearing is to determine whether the evidence does indeed show that the drug is not shown to be safe for use. The hearing thus eventuates in withdrawal of approval only if the Secretary' concludes, based on the evidence of "experience and scientific data" presented at the hearing, that the drug is not shown to be safe.
Id. According to the literal language of the statute and "in accordance with common sense, the agency must issue an order withdrawing approval when it finds that the drug is not shown to be safe--something that, as a matter of statutory command and due process, may only occur after the hearing." Id. at 168. See also 21 U.S.C. [section] 360b(e)(l)(A)-(F) (2008) (outlining FDA withdrawal requirements under FD&C Act). Under the FD&C Act:
[t]he Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) with respect to any new animal drug if the Secretary finds--
(A) that experience or scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved or the condition of use authorized under subsection (a)(4)(A);
(B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary' when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (I) of paragraph (1) of subsection (d) applies to such drug;
(C) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that such drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof;
(D) the patent information prescribed by subsection (c)(3) of this section was not filed within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information;
(E) that the application contains any untrue statement of a material fact; or
(F) that the applicant has made any changes from the standpoint of safety or effectiveness beyond the variations provided for in the application unless he has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application. The supplemental application shall be treated in the same manner as the original application.
Id. See generally Chevron, U.S.A. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984) (finding that courts must not rule against clear congressional intent). "First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress." Id. at 842-43.
(145) See Siegel, supra note 4. Senators Dianne Feinstein, Kirsten Gillibrand, and Elizabeth Warren wrote to the FDA raising concerns in light of the recent ruling finding that the FDA is not required to issue a ban even when a drug is deemed unsafe. Id. But see Withdrawal of FDA Approval for Animal Drug Products, Am. VETERINARY MED. ASS'N, https://www.avma.org/KB/Policies/Pages/Withdrawal-of-FDA-Approval-for-Animal-Drug-Products.aspx (last visited Feb. 17, 2015). Withdrawing an animal drug may have negative effects on animal health and food safety. Id. Prior to withdrawal of an animal drug, or "taking action that may result in a product being withdrawn from the market by the drug sponsor, the AVMA urges FDA-CVM to balance the magnitude of the adverse effects against the risk that may result from continued availability of the drug." Id.
(146) See NRDC, Inc., 760 F.3d at 193. See also U.S GOV'T ACCOUNTABILITY OFFICE, GAO 11-801, ANTIBIOTIC RESISTANCE: AGENCIES HAVE MADE LIMITED PROGRESS ADDRESSING ANTIBIOTIC USE IN ANIMALS (2011), http://www.gao.gov/new.items/d11801.pdf (criticizing the FDA's efforts to mitigate antibiotic resistance). See also Update: FDA's Proposed Withdrawal of Approval of Poultry Flouroquinolones, FOOD & DRUG ADMIN., http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/ucm042012.htm (last visited Feb. 17, 2015) (describing FDA's withdrawal of fluoroquinolones from poultry).
(147) 21 C.F.R. [section] 520.813 (2005) (withdrawing use of fluoroquinolone in poultry feed). FDA proposed the withdrawal of the drug Enrofloxacin in poultry in 2000. Opportunity For Hearing, 65 Fed. Reg. 211 (Oct. 31, 2000) (proposing to withdraw approval for animal growth promoters containing the drug fluoroquinolone); Withdrawal of Approval of New Animal Drug Application, 70 Fed. Reg. 146 (Aug. 1, 2005) (regulating the withdrawal of a fluoroquinolone drug in poultry). See also LEVY, supra note 77, at 171 (describing difficult FDA withdrawal process of drugs). See also GAO 11-801, supra note 146, at 29-30 (discussing lengthy and consuming FDA drug withdrawal process). See also Centner, supra note 81, at 7. In 2005, after appropriate testing by the Centers for Disease Control, the FDA withdrew approval for the use of fluoroquinolones in poultry. Id. See generally Allen C. Cheng et. al., Control of Fluoroquinolone Resistance through Successful Regulation, Australia, MEDSCAPE (Sept. 2012), available at http://wwwnc.cdc.gOv/eid/article/18/9/pdfs/ll-1515.pdf (defining fluoroquinolone and drug uses). "Quinolone antimicrobial drugs are commonly used as first-line empiric therapy for urinary tract infections, upper and lower respiratory tract infections, enteric infections, and gonococcal infection." Id. at 1454.
(148) See HAUTER, supra note 20, at 144 (outlining FDA's flaws with respect to investigating link between antibiotic use and resistance).
(149) See, e.g., 2011 Retail Meat Report, supra note 100 (researching and reporting levels of bacteria in meat). See also GUIDANCE FOR INDUSTRY #209, supra note 83. As a result of the FDA's 1970 Task Force Report and to further research the correlation between antibiotic resistance and antibiotic administration on farms, the Report outlined requirements for drug sponsors to submit data "address [ing] microbiological safety concerns for subtherapeutic uses of antimicrobials in food-producing animals...." Id. at 6. See also 21 C.F.R. [section] 558.15 (outlining requirements for submitting study results showing antibiotic did not promote antibiotic resistant bacteria).
(150) See GAO 11-801, supra note 146. The report notes: "(t]he FDA proposed a voluntary strategy in 2010 that involves FDA working with drug companies to limit approved uses of antibiotics and increasing veterinary supervision of use ... However, the FDA does not collect the antibiotic use data, including the purpose of use, needed to measure the strategy's effectiveness." Id. See also HAUTER, supra note 20, at 144 (highlighting government office's report and criticism of FDA's research). See also Anderson et al., supra note 81, at 374 (linking "antimicrobial agent usage in food animals to resistant foodborne infections in humans").
(151) See 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, supra note 115. The report indicates the hap hazard manner in which drugs are sold and distributed making it impossible to determine how each drug was used:
[b]ecause the majority of antimicrobial drugs used in animal feed are approved for multiple indications, simply knowing that the route of administration for a drug is, for example, by oral means through animal feed cannot, by itself, be used to determine the indication for which the drug was used.... Many of the applications are approved and labeled for use in multiple species, for multiple indications, and with multiple dosage regimens. In addition, some applications are approved for multiple routes of administration, and as OTC and prescription drugs. Because of all these variations, assumptions cannot be made about actual product use.
Id. at 7.
(152) See GAO 11-801, supra note 146, at 10-15 (commenting on FDA's research flaws).
(153) See GAO 11-801, supra note 146, at 11 (outlining Congress reactions to insufficient data collected by FDA and enactment of ADUFA). See also Industrial Food Animal Production in America: Examining the Impact of the Pew Commission's Priority Recommendations, JOHNS HOPKINS CTR. For A LIVABLE Future (2013), http://www.jhsph.edu/research/centers-and-institutes/johns-hopkinscenter-for-a-livable- future/_pdf/research/clf_reports/CLF-PEW-for%20Web.pdf (presenting solutions to antibiotic resistance in humans).
(154) Animal Drug User Fee Amendments of 2008, Pub. L. No. 110-316, 122 Stat. 3509 (requiring FDA to collect sales data from pharmaceutical companies). See also GAO 11-801, supra note 146, at 11. As required under the Animal Drug User Fee Amendments of 2008 (ADUFA), the FDA has been collecting and publishing data from pharmaceutical companies regarding antibiotics sold for livestock. Id.
(155) GAO 04-490, supra note 83, at 12 (explaining agency efforts would be stronger if collected information about specific antibiotic use). See also GAO 11-801, supra note 146, at 10-15 (describing lack of crucial information collected from FDA regarding drug distribution on farms). See also 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, supra note 115. The summary report notes that only the amount and type of antibiotic sold for distribution for food animals is taken into account and collected for data. Id. at 7. According to FDA's 2012 summary report, "the sales and distribution data submitted by animal drug sponsors and summarized in this report are not indicative of how these antimicrobial drugs were actually used in animals (e.g., in what species and for what indications)." Id. See also Orrico, supra note 81, at 274. "The Animal Drug User Fee Act authorizes the FDA to collect fees for animal drug applications and other services and to channel those funds to collect information about antimicrobial drug use." Id. See also Animal Drug User Fee Act (ADUFA), FOOD & DRUG Admin., http://www.fda.gov/forindustry/userfees/animaldruguserfeeactadufa/default.htm (last visited Feb. 17, 2015) (outlining purpose and motive behind ADUFA). See also Industrial Food Animal Production, supra note 153, at 7 (discussing data collected by FDA from pharmaceutical companies regarding animal drugs). The FDA is also directed to test retail meat under the National Antimicrobial Resistance Monitoring System ("NARMS"), and antibiotic resistance in bacteria isolated from livestock, retail meat, and humans is tested. Id. at 4. See also BLASER, supra note 80, at 82 (discussing how Congress did not require FDA to collect information regarding quantities of drugs sold until 2008).
(156) See Antimicrobial Resistance Action Plan, U.S. DEP'T OF AGRIC. (June 2014) available at http://www.usda.gov/documents/usda-antimicrobial-resistance-action-plan.pdf (discussing current actions and possible future proposals to remedy antibiotic resistance). USDA's new plan describes "how the USDA proposes to obtain and disseminate science-based, actionable, information about antibiotic drug use, its potential role in the development of antibiotic resistance in food-producing animals, and the relationship of drug use and resistance patterns to livestock management practices." Id. at 2. In the USDA's report it states that alternatives to antibiotics are "broadly defined as any substance that can prevent the need for or be substituted for therapeutic use." Id. at 8. "Ongoing voluntary monitoring of antibiotic use, AMR patterns, and management practices associated with food-producing animals and their environments at multiple points from the farm through slaughter and processing is essential." Id. at 5.
(157) See infra notes 158-160 (describing USDA's research efforts regarding antibiotic resistance).
(158) See GAO 11-801, supra note 146, at 11 (discussing USDA efforts to collect data regarding antibiotic resistance).
(159) See id. at 13-15. NAHMS is a periodic, national survey and collect on-farm data regarding how antibiotics are administered, and in what situations producers distribute antibiotics to livestock. Id. at 13. Under APHIS, employees go to farms multiple times over the course of 3 to 6 months and examine producers' practices. Id.
(160) See id. Agricultural Resource Management Survey (ARMS) is a survey of farms conducted since 1996. Id.
ERS uses ARMS data to study how production practices, including antibiotic use, affect financial performance and whether specific production practices can substitute for other production practices. For example, a January 2011 ERS study found that broiler chicken producers who forgo sub-therapeutic uses of antibiotics (i.e., use in chickens that are not ill) tend to use distinctly different production practices, such as testing flocks and feed for pathogens, fully cleaning chicken houses between each flock, and feeding chickens exclusively from vegetable sources. However, like NAHMS, ARMS cannot be used to examine trends in antibiotic use over time because ERS does not resurvey the same farms over time or conduct annual surveys on specific commodities.
GAO 11-801, supra note 146, at 13.
(161) Id. The 2011 GAO report further found:
NAHMS produces a snapshot of antibiotic use practices in a particular species, but the data it collects cannot be used to monitor trends in the amount of antibiotics used over time. According to APHIS officials, these limitations remain today. For example, these officials said that NAHMS is limited by long lag times (approximately 6 years) between surveys of the same species, changes in methodology and survey populations between studies, reliance on voluntary participation by food animal producers, and collection of qualitative, rather than quantitative information on antibiotic use.
(163) Animal Health Statistical Surveys and Confidentiality National Animal Health Monitoring System, U.S. DEP'T OF AGRIC., http://www.aphis.usda.gov/animal_health/nahms/general/downloads/ NAHMS_CTPSEA.pdf (last visited Feb. 22, 2015) (outlining NAHMS procedures and confidentiality of producer participation). When conducting a study, NAHMS asks producers to voluntarily provide information regarding animal health and productions practices on the farm. Id. Farm Production Expenditures Methodology and Quality Measures, U.S. DEP'T OF AGRIC. (Aug. 2, 2015), available at http://www.nass.usda.gov/Publications/Methodology_and_Data_Quality/Farm_Production_Expenditures/08_2013/fpxq0813.pdf (describing phases of ARMS survey and its scope and purpose). "Response to ARMS is voluntary. Some producers refuse to participate in the survey, others cannot be located during the data collection period, and some submit incomplete reports." Id. at 3.
(164) See supra notes 75-76 (describing USDA inspection authority derived from FMIA, PPIA and EPIA).
(165) 21 C.F.R. [section] 556 (2014) (establishing amount of antibiotics legally permitted in meat and dairy products). Specifically, 0.5 part per million of penicillin is permitted in the edible tissues of cattle. [section] 556.510(a). See also U.S. Residue limits for Veterinary Drugs, Food, Additives, and Unavoidable Contaminants in Meat, Poultry, and Egg Products, U.S. DEP'T OF AGRIC., available at http://www.fsis.usda.gov/OPHS/red_book_2001/2001_Residue_Limits_Veterinary_Drugs_Ap p4.pdf (setting out levels of antibiotic residues allowed in meat and dairy products).
(166) See United States National Residue Program for Meat, Poultry, and Egg Products 2014 Sampling Plans, U.S. DEP'T OF AGRIC. (2014), http://www.fsis.usda.gov/wps/wcm/connect/533beea8-lbcf468e-al3b-531232b2af2f/2014-Blue- Book.pdf?MOD=AJ PERES (outlining the process of sampling antibiotic residues). See also United States National Residue Program for Meat, Poultry, and Egg Products 2013 Residue Sampling Plans, U.S. DEP'T OF AGRIC. (2013), http://www.fsis.usda.gov/wps/wcm/connect/7fec09dd-3a79-4aa8-8974-97d96bc82ee3/2013-Blue-Book.pdf?MOD=AJP ERES (detailing methods used to plan and design the sampling plans). See also 21 C.F.R. [section] 558 (outlining withdrawal period requirement for each new approved animal drug); 21 C.F.R. [section] 522 (2014) (providing specific withdrawal period for certain antibiotics). See also Inspections, Compliance, Enforcement, and Criminal Investigations, FOOD & DRUG ADMIN., http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074661.htm (last visited Feb. 11, 2015). Failure to observe drug withdrawal periods before slaughter is the main cause of illegal drug residue levels. Id.
In determining responsibility for illegal residues the concept of "causing," as expressed in Section 301 of the Act must be developed. Acts under the "causing" concept may be committed by one or more individuals in the production and marketing chain when illegal residues occur and, if justified by the facts, charges should be considered against these individuals. Therefore, all investigations of illegal residues should determine the culpability of any and all individuals who may have acted (or failed to act) in such a way as to be responsible for illegal residues.
Id. See also 21 U.S.C. [section] 331(a) (2012) (outlining prohibited acts and penalties under the FD&C Act); Inspections, Compliance, enforcement, and Criminal Investigations, supra. See also Compliance Program Guidance Manual: Illegal Residues in Meat, Poultry, Seafood, and other Animal Derived Foods, FOOD & DRUG Admin. (2005), available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucml 13433.pdf (discussing FDA's procedure when illegal levels of drug residue found). FDA districts conduct on-site inspections once illegal residues from FSIS are reported to the Agency. Id. at 10-13. During an on-farm investigation, the investigator will look for inventory of all drugs on the premises, determine and list other drug-containing products that may have been used, determine where the drugs are stored on the farm as well as who has access to the antibiotics. Id. at 19. During the investigation, FDA would also interview who administers the drugs to the animals, and determine their distribution practices of the drugs, such as when drugs are given and for what reason. Id. at 20. Other information obtained on the visit would be the records regarding the dates of specific medications used, the dosage as well as withdrawal times. Id. The producer would need to show how he has assured compliance with withdrawal periods. Id. Regulatory action can be taken against a producer when it has been documented that the animals offered for slaughter in interstate commerce resulted in illegal residues or by showing that the violators "caused" the illegal residues to be introduced in interstate commerce. 21 U.S.C. [section] 331(a); Compliance Program Guidance Manual, supra at 22. Rut see FSIS National Residue Program for Cattle, U.S. DEP'T OF AGRIC. (2010), http://www.usda.gov/oig/webdocs/24601-08-KC.pdf (analysis of FSIS efforts under the National Residue Program). Based on the USDA Office of Inspector's report, FSIS is not "accomplishing its mission of monitoring the food supply for many harmful residues." Id. at 1. Furthermore, the report notes that FSIS does not attempt to recall meat when its tests have confirmed the excess of veterinary drugs in samples. Id. at 4.
(167) Preservation of Antibiotics for Medical Treatment, H.R. 1150, 113th Cong. (2013) (proposing amendment to FD&C Act, requiring withdrawal of medically important drugs for nontherapeutic use).
(168) H.R. 1150, 113th Cong, (requiring medically important drugs be withdrawn from animal feed for growth promotion use); H.R. 1150: Preservation of Antibiotics for Medical Treatment Act of 2013, https://www.govtrack.us/congress/bills/113/hrl 150#summary (last visited Feb. 18, 2015) (outlining summary of bill). See also Davis & Rutkow, supra note 111, at 359. PAMTA was first introduced to the 106th Congress in 1999 and has been introduced several times over the past decade. Id. See also HAUTF.R, supra note 20, at 143 (discussing PAMTA's objectives); Industrial Food Animal Production, supra note 153, at 7 (discussing anticipated beneficial effects of PAMTA); Preservation of Antibiotics for Medical Treatment Act (PAMTA)--H.R. 1150, Am. VETF.RINARY Med. ASS'N, https://www.avma.org/Advocacy/National/Documents/IB_PAMTA_4-l-2014.pdf (last visited Feb. 18, 2015) (discussing implications and problems with proposed bill); Helena Bottemiller, Rep. Slaughter Reintroduces PAMTA, Criticises FDA Strategy for Tackling Antibiotic Resistance, FOOD SAFETY NEWS (Mar. 15, 2013), http://www.foodsafetynews.com/2013/03/repslaughter-reintroduces-pamta-criticizes-fdas-strategy-for-tackling-antibiotic- resistance/#.VMUJ2 YvIbOs (last visited Feb. 18, 2015) (discussing updated legislation). The latest legislation now intends to cover cephalosporins, making a total of eight medically important antibiotics banned from non-therapeutic use. Id.
(169) See H.R. 1150; The Preservation of Antibiotics for Medical Treatment Act, CONGRESSWOMAN LOUISE M. SLAUGHTER, http://www.louise.house.gov/the-preservation-of-antibiotics-for-medical-treatment-act (last visited Feb. 18, 2015) (summarizing PAMTA's objectives).
(170) See Patrick Graves, Keith Mosman, & Shayna Rogers, 2011 legislative and Administrative Review, 18 ANIMAL L. 361, 376 (2012) (discussing obstacles that PAMTA faces). PAMTA would allow the FDA to withdraw approval for medically important drugs for non-therapeutic purposes, instead of using the difficult withdrawal process currently in effect. See id.
(171) See Preservation of Antibiotics for Medical Treatment Act of 2013, supra note 168. There is a one percent chance of the bill being enacted. Id. See also HAUTER, supra note 20, at 143, 146 (describing unlikelihood of PAMTA passing due to industry pressures). Other efforts include President Obama's executive order on September 18, 2014, outlining a five-year strategy that would monitor antibiotic use and its link to antibiotic resistant infections. Executive Order Combating Antibiotic-Resistant Bacteria, WHITEHOUSE.GOV (Sept. 18, 2014), http://www.whkehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria. The strategy focuses on researching antibiotic resistant infections as well as "promoting new and next generation antibiotics and diagnostics." Id.
(172) See HAUTER, supra note 20, at 145 (discussing industry pressures halting progression in legislation such as PAMTA).
(173) Graves et ah, supra note 170, at 376-77. Progression towards creating a solution for antibiotic resistance is stalled by the meatpacking industry:
As regulators evaluate agricultural uses of antibiotics, the agricultural industry has lobbied extensively against PAMTA. Major agricultural organizations including the American Farm Bureau Federation, National Cattlemen's Beef Association, and National Hog Farmer--allege that prohibiting nontherapeutic antibiotic use will result in increased animal disease and higher meat prices, and that it will not reduce the emergence of antibiotic resistant strains of disease.
Id. at 377. These companies also play a major role in preventing progression in the defense against antibiotic resistance through their lobbyist efforts. Id.
(174) See STULL & BROADWAY, supra note 25, at 17. Farmers are now referred to as "growers" and specialize in a single species of animal by using either hog barns, feedlots, or chicken houses to raise the animals. Id. In poultry and pork industries, large processors known as "integrators" own the animals on the farms, and contract with the growers to raise the animals until they reach slaughter weight. Id. Then the company that contracted with the growers will transport the animals to the processing plants for slaughter. Id. Growers then receive compensation from the companies based on "feed conversion ratio" and thus strive to grow animals as quickly as possible. Id.
(175) See HAUTER, supra note 20, at 172-73. The trends over the past few decades:
[i]n 1993, almost all hog sales (87 percent) were negotiated purchases between farmers and packers or processors (known as "spot market" sales). Because the packers relied on family farmers, it gave these producers some negotiating power with the large corporations. But by 2006, nearly all hogs (90 percent) were controlled by the packers, either by owning their hogs outright (20 percent) or through production-contracted hogs (70 percent).
Id. at 173.
(176) See HAUTER, supra note 20, at 172 (describing pressure placed on farmers to abide by meatpacking contracts). See also Challenging Concentration of Controls in the American Meat Industry, supra note 20, at 2646. "Processors are much more likely to buy from producers who will follow their prescribed methods, and they offer higher prices to producers who provide them with large numbers of animals - that is, large-scale factory farms." Id.
(177) See HAUTER, supra note 20, at 172. Typically six hog warehouses containing approximately eleven hundred hogs cost between $600,000 and $900,000. Id. Today, the USDA-enforced Grain Inspection, Packers & Stockyards Administration (GIPSA) controls livestock marketing practices of meatpackers and was intended to prevent the meat packing industry from using unfair, deceptive, and discriminatory practices against producers of livestock. Id. at 172. Despite GIPSA in effect for almost one hundred years, the act has generated very little impact, achieving no meaningful change. Id. at 159. See also Bill Bullard, Under Siege: The Live Cattle Industry 58 S.D. L. REV. 560, 563 (discussing concentration of beef farms and meatpacking industry).
(178) See HAUTER, supra note 20, at 172. Meatpackers have pressured farmers to "get big or get out." Id.
(179) See HAUTER, supra note 20, at 172 (describing quick evolution from small farms to industrialization of hog farms).
(180) See STULL & BROADWAY, supra note 25, at 17 (describing farmers under pressure to fulfill contracts with meatpackers).
(182) Id at 15. Meat-packing processing plants contract with producers to provide them with livestock and have increased contracts over the years. Id. For instance, "in the early 1980s, less than 5 percent of U.S. hogs went to market under some type of contract; in 2008, more than 88 percent were committed to packers through direct ownership or contract arrangements." Id. "By 2010, the four-firm buyer concentration level in the fed cattle market hit a new record of 85%, meaning that just four firms slaughtered 85% of all the steers and heifers fed in U.S. feedlots." Bullard, supra note 177, at 563. See also DAVID KIRBY, ANIMAL FACTORY: THE LOOMING THREAT OF INDUSTRIAL PIG, DAIRY, AND POULTRY FARMS TO THE HUMANS AND THE ENVIRONMENT 2 (2010) (discussing "vertical integration" or how large companies control most factory farm operations today). See also supra note 25 (discussing concentration of factory farms today and immense control exerted by meat-packing industry). See also Trends in Health and Management Practices on U.S. Feedlots, U.S. DEPT. OF AGRIC., supra note 3 (discussing antibiotic use trends on farms). See generally Leo Horrigan, Jay Granham & Shawn McKenzie, Antibiotic Drug Abuse: CAFOs are Squandering 17tal Human Medicines in The CAFO READER: The TRAGEDY OF INDUSTRIAL ANIMAL FACTORIES 254, 261 (Daniel Imhoff ed., 2010). Instead of phasing out the modern farming model, the livestock industry have began to "develop animals that are permanently altered at the genetic level to better fit the CAFO system ... so that they can become more efficient production machines and maximize industry profits." See generally Jaydee Hanson, Genetically Engineered Farm Animals: A Brazen Effort to Make Nature Fit the Industrial Mold, in THE CAFO READER: THE TRAGEDY OF INDUSTRIAL ANIMAL FACTORIES 273 (Daniel Imhoff ed., 2010) (explaining shift to genetically engineered farm animals).
(183) See FRAN HAWTHORNE, INSIDE THE FDA: THE BUSINESS AND POLITICS BEHIND THE DRUGS WE TAKE AND THE FOOD WE EAT 147 (2006) (discussing present industry control over the FDA and history).
(184) Big Pharma, DRUG WATCH, http://www.drugwatch.com/manufacturer/ (last visited Jan. 29, 2015). "From 1998 to 2013, Big Pharma spent nearly $2.7 billion on lobbying expenses--more than any other industry." Id. See also HAWTHORNE, supra note 183, at 145. The Pharmaceutical Research and Manufacturers of America ("PhRMA"), spend about $150 million a year in lobbying, with $5 million to just lobby FDA. Id.
(185) See HAUTER, supra note 20, at 143 (arguing that "extensive misuse" of antibiotics on farms makes pharmaceutical industry a lucrative market).
(186) See Companies Speak Out Against Antibiotic Use on Yams, FOOD & WATF.R WATCH (May 21, 2014), http://www.foodandwaterwatch.org/pressreleases/communities-speak-out-against-antibiotic-abuse-on-factory-farms/. Organizations and companies lobbied against PAMTA spent a total of 171 million dollars between 2010 and 2013--seventy two percent was contributed from pharmaceutical companies, while twenty seven percent was contributed from agriculture and meat packing groups. Id. See also HAUTER, supra note 20, at 145. Between 1998 and 2011, the drug industry' spent 2.3 billion dollars to lobby against the PAMTA bill. Id. "Campaign contributions to federal elected officials between 1990 and 2011 amounted to 131 million, with 66 percent going to republicans and 34 percent to democrats." Id. See also Antibiotic Resistance 101, supra note 81, at 16. "Thirty organizations have lobbied on PAMTA over the years with organizations representing the meat, livestock and pharmaceutical industries all voicing opposition." Id.
(187) See Parts II.A-C. (discussing efforts by FDA, the USD A, and legislation to limit antibiotic use on farms). See also supra notes 77, 86-88 and accompanying text (discussing vital and prevalent sub-therapeutic distribution of antibiotics on current farms and subsequent antibiotic resistance in humans); supra Parts I.B.i.-v. (discussing current CAFO conditions inflicting pain and suffering to farm animals).
(188) See supra notes 167-170 (discussing PAMTA bill's objectives to withdrawal approval of drugs for non-therapeutic purposes); supra notes 118-125 (outlining FDA's guidance aiming to eliminate growth promotion use of antibiotics).
(189) See GUIDANCE FOR INDUSTRY #213, supra note 10 (outlining FDA's plan to phase out antibiotic use for only growth promotion).
(190) GUIDANCE FOR INDUSTRY #213, supra note 10 (discussing guidance will phase out only growth promotion uses); supra notes 118-125 and accompanying text (outlining and describing FDA's guidance directed at phasing out non-therapeutic growth use of antibiotics); Gaps in FDA's Antibiotics Policy, supra note 134 (suggesting FDA's approach will not diminish resistance due to major gaps in its guidance).
(191) See LEVY, supra note 77, at 172 (suggesting connection between antibiotic use and confinement on factory farms); Lessing, supra note 3, at 464 (discussing current extensive use of sub-therapeutic dosing in order to closely confine animals). See also GUIDANCE FOR INDUSTRY #213, supra note 10 (considering disease prevention use to be judicious).
(192) See GUIDANCE FOR INDUSTRY #213, supra note 10 (explaining antibiotics should be used judiciously to control and treat disease); FDA's Strategy on Antimicrobial Resistance, supra note 123 (stating that under new plan disease prevention use will be administered judiciously with veterinary oversight).
(193) See Krans, supra note 125 (arguing farmers will continue to administer drugs in similar amounts despite FDA's new plan). See also Gaps in FDA's Antibiotics Policy, supra note 134 (discussing lenient and ambiguous labeling standards with regard to disease prevention and growth enhancement).
(194) See Gaps in FDA's Antibiotics Policy, supra note 134 (exposing ambiguous labeling used by pharmaceutical companies allowed by FDA); GUIDANCE FOR INDUSTRY #213, supra note 10 (claiming that phase out of growth promotion will end injudicious use of antibiotics on farms).
(195) See Levy, supra note 77, at 155 (explaining that recently growth promotion is administered in higher doses similar to therapeutic doses); Gaps in FDA's Antibiotics Polity, supra note 134 (finding no distinguishable difference between growth promotion and disease prevention use). See also Krans, supra note 125 (arguing farmers will use the same amount of antibiotics regardless of FDA guidance).
(196) See GAO 11-801, supra note 146, at 26-29. The report noted that FDA will be unable to measure the effectiveness of their newest guidance because the agency does not collect data on the purposes the antibiotics serve. Id.; 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food Producing Animals, supra note 115 (finding FDA's research inadequate to ascertain benefits of voluntary plan); supra notes 148-155 (exhibiting FDA's inability and lack of research to distinguish between growth and prevention uses).
(197) See GAO 11-801, supra note 146, at 26-29 (highlighting FDA's inability to ascertain benefits of new plan due to lack of data); 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, supra note 143 (exhibiting no data regarding the purposes of the 32 million drugs sold in 2012). See also Lessing, supra note 3, at 464 (discussing extensive use of antibiotics on farms to compensate for farming operations).
(198) See GAO 11-801, supra note 146, at 26-29 (highlighting FDA's inability to ascertain benefits of new plan due to lack of data). See also supra notes 157-163 and accompanying text (exhibiting USDA's role in researching antibiotic resistance and the agency's limited data); supra notes 148155 (discussing FDA's restricted research and lack of knowledge regarding for what purposes antibiotics are administered).
(199) See Tomaselli, supra note 127, at 527 (criticizing FDA's guidances as half measures). See also Krans, supra note 125 (discussing gaps in FDA's guidance); supra notes 148-152 and accompanying text (suggesting FDA's inability to distinguish between preemptive and growth promotion uses).
(200) See GUIDANCE FOR INDUSTRY #213, supra note 10, at 4-5 (surmising that placing drugs under veterinary oversight will solve the extensive use of antibiotics). See also supra notes 128-135 and accompanying text (discussing shift from over the counter to veterinary oversight in FDA's guidance).
(201) GUIDANCE FOR INDUSTRY #213, supra note 10, at 4-5 (explaining shift to over the counter to veterinary oversight). See FDA's Strategy on Antimicrobial Resistance, supra note 123 (explaining FDA's view that veterinary oversight will decrease antibiotic use). The FDA surmises that once the guidance is implemented "medically important antimicrobial drugs can no longer be used for production purposes, and their continued use to treat, control, or prevent disease in food animals will require an order or prescription from a licensed veterinarian." Id.
(202) See FDA's Strategy on Antimicrobial Resistance, supra note 123 (explaining FDA's position and objectives of new guidance). The FDA gives the example for when a veterinarian may prescribe antibiotics for disease prevention:
A veterinarian may determine, based on the client's production practices and history, that weaned beef calves arriving at a feedlot in bad weather after a lengthy transport are at risk to develop bacterial respiratory infection. In this case, the veterinarian might choose to preventively treat these calves with an antimicrobial approved for prevention of that bacterial infection. On the other hand, FDA would not consider a judicious use for prevention to be the administration of a drug to apparently healthy animals in the absence of any information that such animals were at risk of a specific disease.
Id. See also LEVY, supra note 77, at 172 (suggesting more antibiotics are used in confined situations); Lessing, supra note 3, at 464 (discussing how CAFO conditions necessitate excessive antibiotic administration); supra notes 86-87 (discussing vital sub-therapeutic administration of drugs due to unhealthy CAFO practices). See also Part I.B.1-5 (outlining extreme animal confinement and inhumane conditions on CAFOs contributing to poor animal health).
(203) See FDA's Strategy on Antimicrobial Resistance, supra note 123 (illustrating how FDA intends to execute guidance). Under FDA's guidance, veterinarians will still proscribe specific medically important antibiotics, aimed at curing the certain disease, rather than phasing out medically important drugs altogether. See id. See also supra notes 86-87 (discussing administration of drugs for disease prevention).
(204) See supra notes 86-87 and accompanying text (outlining sub-therapeutic administration necessary on farms to prevent imminent disease due to confinement); supra notes 118-125 and accompanying text (discussing FDA's guidance solely focused on the phase out of growth enhancement).
(205) See supra notes 157-163 and accompanying text (exhibiting USDA's mission to research ways to lower antibiotic administration); supra notes 148-155 (discussing FDA's inadequate research).
(206) See supra note 10 (focusing on limiting drug use); supra notes 157-163 and accompanying text (outlining USDA's inadequate research on antibiotic resistance).
(207) See supra notes 86-87 and accompanying text (describing antibiotic administration for disease prevention necessary on CAFOs); supra Part I.B.i.-v. (discussing factory farm practices).
(208) Natural Res. Def. Council, Inc. v. U.S Food and Drug Admin., 760 F.3d 151, at 171-72 (2nd Cir. 2014). In the majority's view, the FDA has full discretion under the statute even when a drug is preliminarily considered unsafe:
Our survey of the text, the context, the regulations, and the background legal principles leave us firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage, that the FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs by issuing or withdrawing NOOHs ...
Id. See also 21 U.S.C. [section] 360b(e)(l) (explaining orders for withdrawal of approval). See NRDC, Inc., 760 F.3d at 171. The court states that "[t]he issue here is not whether Congress can impose the sort of mandate plaintiffs would find in the statute--of course it can--but whether Congress has done so." Id.
(209) See id. at 171-72.
(210) See id.
(211) See 1YRDC, Inc, 760 F.3d at 177. The Second Circuit notes:
[i]t is relatively easy for us to accept the FDA's determination that its preferred program of voluntary compliance offers greater prospect for immediate and significant reductions in animal antibiotic use than the pursuit of a potentially contentious withdrawal hearing. That is the sort of prudential judgment better suited to expert administrators than to federal judges.
Id at 175.
(212) See supra notes 72-76 (discussing FDA's and USDA's lack of authority to address confinement and sanitation standards on farms).
(213) See LEVY, supra note 77, at 172 (noting connection between extensive use of antibiotics and confinement); supra notes 87 (explaining sub-therapeutic drug distribution keeps animals healthy on factory farms). See also Part I.B.i.-v. (outlining extreme animal confinement and inhumane conditions on CAFOs contributing to poor animal health). Farm animals receive no federal protection. See also Humane Slaughter Act, 7 U.S.C.[section][section] 1901-07 (2006) (providing for humane slaughter of farm animals except chickens); Twenty-Eight Hour Law, 49 U.S.C. [section] 80502 (2006) (mandating animals may be confined in transportation no longer than 28 hours); Animal Welfare Act, 7 U.S.C. [section] 2132(g) (2006) (exempting farm animals from animal welfare standards); supra note 64 and accompanying text (discussing the lack of protection farm animals receive under state and federal laws); Matheny & Leahy, supra note 21, at 334 (discussing weak laws regarding welfare protection for farm animals).
(214) See supra note 75 and accompanying text (outlining USDA's authority to inspect meat under FMIA); supra note 76 (outlining USDA's lack of authority to inspect or over on-farm operations); supra notes 164-166 and accompanying text (discussing USDA ability to inspect meat for illegal antibiotic residues); supra notes 107-110 and accompanying text (delineating FDA's power under the PHSA and FDCA). See also Stathopoulos, supra note 8, at 434-36 (describing limited USDA and FDA authority to regulate at the farm-level).
(215) See Stathopoulos, supra note 8, at 434, 437 (discussing USDA's and FDA's post hoc approach towards food safety).
(216) See GUIDANCE FOR INDUSTRY #213, supra note 10 (attempting to limit antibiotic use by phasing out growth promotion); supra notes 164-166 and accompanying text (USDA's attempt to inspect meat for high antibiotic residue levels).
(217) See LEVY, supra note 77, at 172 (linking antibiotic use with farm animal confinement); GUIDANCE FOR INDUSTRY #213, supra note 10 (limiting growth promotion use in attempts to decrease antibiotic resistance).
(218) See supra notes 107-110 and accompanying text (discussing the FDA's current regulatory authority).
(219) See Orrico, supra note 81, at 287-88 (arguing improved animal welfare would diminish antibiotic use on farms).
(220) See supra notes 67, 69 and accompanying text (explaining USDA regulates animal welfare on organic farms under the agency's certified organic label).
(221) See supra notes 67, 69, 91 and accompanying text (discussing animals must be raised without antibiotics under USDA organic label).
(222) See supra notes 67, 69 and accompanying text (explaining USDA regulations concerning confinement on organic farms).
(223) See U.S. CONST, art. I, [section] 1. (stating Congress must mandate legislation); supra note 73 and accompanying text (stating that Congress must grant power to federal agencies).
(224) See Preservation of Antibiotics for Medical Treatment, H.R. 1150, 113th Cong. (2013) (legislature outlawing only non-therapeutic use of medically important drugs).
(225) See H.R. 1150. The PAMTA bill defines non-therapeutic as "including] any repeated or regular pattern of use of medically important antimicrobials for purposes other than therapeutic use or nonroutine disease control." Id. Further, the draft defines "nonroutine" as the "use of antibiotics on an animal that is not sick but where it can be shown that a particular disease or infection is present, or is likely to occur because of a specific, noncustomary situation, on the premises at the barn, house, pen, or other level at which the animal is kept." Id.
(226) See H.R. 1150 (focusing solely on limiting medically important drugs for growth promotion use).
(227) See LEVY, supra note 77, at 172 (noting that farm practices correlate with how much antibiotics are used). See also supra notes 86-87 (describing need for repeated sub-therapeutic drug distribution to keep animals healthy for human consumption).
(228) See supra note 64 and accompanying text (discussing federal protections for animals explicitly exempting farm animals or merely providing standards for slaughter). See supra Part III.D (discussing immense control and power meat-packing and pharmaceutical industries exert over government agencies).
(229) See HAUTER, supra note 20, at 145 (discussing industry lobbyist efforts); Graves et al., supra note 170, at 376-77 (presenting obstacles PAMTA faces due to pharmaceutical industry pressure).
(230) See Krans, supra note 125 (explaining use of antibiotics on farms have created profitable market for drug companies) ... [T]he global market for veterinary antibiotics is expected to reach 19.54 billion by the year 2020." Id. See HAUTF.R, supra note 20, at 143, 145 (explaining extensive use of antibiotics is highly profitable to pharmaceutical industry). See supra notes 184186 and accompanying text (discussing pharmaceutical industry and present control over FDA).
(231) See supra notes 184-186 and accompanying text (discussing how pharmaceutical industry exerts control over FDA).
(232) See Krans, supra note 125 (revealing pharmaceutical industry pressures on FDA).
(233) See FDA Secures Full Industry Engagement on Antimicrobial Resistance Strategy, supra note 133 (stating FDA received full industry compliance with newest guidance). See also supra notes 130-133 and accompanying text (describing industry compliance with FDA's recent guidance); supra notes 134-137 and accompanying text (describing FDA's flaws in guidance regarding ambiguous labeling of drugs).
(234) See supra notes 126-129 and accompanying text (discussing FDA's voluntary measures and criticism for leniency on industry). See also supra note 186 and accompanying text (discussing amount pharmaceutical companies spend to retain control over FDA).
(235) See supra notes 24-25, 173-181 and accompanying text (discussing meat-packing industry power over farm operations and creation of large, confined CAFOs).
(236) See supra notes 176-181 and accompanying text (describing pressure and effect on farmers to uphold contracts with meat-packers).
(237) See supra notes 27, 77, 86-87 and accompanying text (discussing sub-therapeutic distribution of antibiotics to compensate for CAFOs conditions and subsequent resistance in humans); supra note 182 and accompanying text (indicating meat-packing preservation of CAFOs).
Amanda Belanger, J.D. Candidate, Suffolk University Law School, 2015; B.A., University of Massachusetts Amherst, 2012. Ms. Belanger may be contacted at ambelal590gmail.com.
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|Title Annotation:||Continuation of II. Federal Agency Approach to Preventing Antibiotic Resistance A. FDA's Role in Protecting Against Antibiotic Resistance through Conclusion, with footnotes, p. 171- 197|
|Publication:||Journal of Health & Biomedical Law|
|Date:||Sep 22, 2015|
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