INTL613Wk4
Jordan Hunter*
Preparing for Agroterror: How is the Texas Animal Health Commission Implementing Federal Food Security Regulations?
DOI 10.1515/jbbbl-2015-0005
Abstract: Agroterrorism is a subform of bioterrorism with the potential to have a crippling impact on both the agricultural industry and the food supply of a nation. A calculated attack using a miniscule amount of pathogenic or disease causing substances on the livestock or crops in one rural community can spread to animals andmetropolitan regions much farther away long before any response from state or federal veterinary or agricultural organizations. Although there have been no large- scale agroterrorism attacks in the United States, there have been historical prece- dents for agricultural biological warfare and recent examples of unintentional or accidental spread of pathogens in the food supply that have threatened the health and safety of the public. Along with an ongoing push for preparedness to prevent a biological attack on the U.S. agricultural industry, there is a great deal of uncer- tainty and conflict among landowners, farmers, analysts, and politicians about what methods should be implemented to safeguard the public. In response to this possible threat, the United States government has implemented legislation that it considers preemptive in its ability to safeguard the food supply and manage the public health and/or biological crime response in a widespread agroterrorist attack scenario. However, this requires cooperation on both the state and federal levels, and of several agencies including the department of Health, U.S. Department of Agriculture (USDA), Federal Bureau of Investigation, and the Department of Health and Human Services. This paper examines the steps being taken by the USDA in fulfilling the orders of the federal government in response to the looming threat of agroterrorism and how the TAHC works cooperatively with federal agencies and the private agricultural industry to carry out these regulations.
Keywords: Agroterrorism, bioterrorism, animal health commission
*Corresponding author: Jordan Hunter, The Institute of Environmental and Human Health, Texas Tech University, E-mail: [email protected]
Journal of Biosecurity, Biosafety and Biodefense Law 2015; 6(1): 65–85
I. What is Agroterrorism?
Agroterrorism is a subform of bioterrorism with the potential to have a crippling impact on both the agricultural industry and the food supply of a nation.1
A calculated attack using a miniscule amount of pathogenic or disease causing substances on the livestock or crops in one rural community can spread to animals and metropolitan regions much farther away long before any response from state or federal veterinary or agricultural organizations.2 This would not only lead to significant monetary loss, but would also damage the psyche of the population that must then cope with debilitating food shortages, the threat of possible animal to human zoonotic disease transmission, and the fear incited by terrorism.
Although there have been no large-scale agroterrorism attacks in the United States, there have been historical precedents for agricultural biological warfare and recent examples of unintentional or accidental spread of pathogens in the food supply that have threatened the health and safety of the public.3 The outbreaks of E. coli from contaminated spinach in 2006 and 2013 stretched across multiple states, including Washington, California, and Texas. The 2006 outbreak encompassed a much larger portionofNorthAmerica.4 TheUnitedKingdomexperiencedanoutbreak of foot-and-mouth disease among livestock that led to a loss of billions of dollars in tourism and agriculture, and resulted in the destruction of millions of animals.5
Along with an ongoing push for preparedness to prevent a biological attack on the U.S. agricultural industry, there is a great deal of uncertainty and conflict among landowners, farmers, analysts, and politicians about what methods should be implemented to safeguard the public. To compound this, some view the eagerness to have a preventive strategy in place—when based upon no evidence of threat or prior incidents—as overzealous.6 However, it is generally agreed that the size and scope of many produce-and-cattle agricultural opera- tions makes them a challenge to completely safeguard from all instances of attack or contamination. Those with experience in this field still acknowledge that current large scale farms remain vulnerable to attack.7
1 Henry Parker, AGRICULTURal BIOTERRORISM: A FEDERAL STRATEGY TO MEET THE THREAT (2002). 2 Id. at 16. 3 Albert Stirrup, Hidden Cargo: A Cautionary Tale About Agroterrorism and the Safety of Imported Produce, 16, SAN JOAQUIN AGRIC. L. REV. 171 (2006–2007). 4 Id. at 3. 5 Id. 6 Jesse Hirsch, Food (In)security: Are Farms The Next Terrorist Target?, MOD. FARMER (Dec. 16, 2013), http://modernfarmer.com/2013/12/food-insecurity-farms-next-terrorist-target. 7 Parker, supra note 1, at 12.
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In response to this possible threat, the United States government has imple- mented legislation that it considers preemptive in its ability to safeguard the food supply and manage the public health and/or biological crime response in a widespread agroterrorist attack scenario.8 However, this requires cooperation on both the state and federal levels, and of several agencies including the Department of Health, U.S. Department of Agriculture (USDA), Federal Bureau of Investigation, and the Department of Health and Human Services.9 In addi- tion, the origin of the biological threat and the agricultural sector affected by contamination, such as crops or meat from livestock, fall under two different agencies—the Federal Department of Agriculture (FDA) and the USDA.10 The complexity of organizing a response across multiple agencies raises many questions regarding the degree of responsibility farmers, landowners, and pri- vate companies should have in securing their livestock and property from biological attack under the law.
A critical part of safeguarding agriculture in the state of Texas is the close cooperation between federal and state agencies and private industry. While the USDA and Animal Plant Health Inspection Service (APHIS) have initiated certain regulations for the protection of livestock in particular—the state must take respon- sibility for implementing these guidelines.11 For this purpose the Texas Animal Health Commission (TAHC) is the primary agency in charge of coordinating efforts concerning unintentional or intentionally introduced diseases in livestock within the state of Texas.12 This paper will examine the steps being taken by the USDA in fulfilling the orders of the federal government in response to the looming threat of agroterrorism and how the TAHC works cooperatively with federal agencies and the private agricultural industry to carry out these regulations.
II. Agroterrorism in History
Agroterrorism as a form of biological warfare is not a new concept.13 In Ancient Greece Solon of Athens used the herb hellebore to contaminate the water supply
8 Jim Monke, CONG. RESEARCH SERV., RL32521, AGROTERRORISM: THREATS AND PREPAREDNESS 12–24 (2007). 9 Id. 10 Id. 11 USDA, Animal and Animal Product Import Information, (Apr. 23 2014) http://www.aphis. usda.gov/wps/portal/aphis/ourfocus/animalhealth?1dmy&urile=wcm%3apath%3a%2FAPHIS_ Content_Library%2FSA_Our_Focus%2FSA_Animal_Health%2FSA_Import_into_US. 12 6 TEX. AGRIC. CODE § 161.041. 13 Dean Olson, Agroterrorism Threats to America’s Economy and Food Supply, FBI L. ENFORCEMENT
BULLETIN (Feb. 2012).
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in the siege of Krissa.14 In the same period, the Assyrians were known to have used rye ergot to poison their opponents’ wells.15 German forces in World War I intentionally infected the opposing Allied forces’ horses and cattle with glanders as they traveled to France.16 During the second Sino-Japanese war from 1937– 1945, the Japanese forces used ceramic bombs containing several pathogens known to cause anthrax, typhoid, and cholera, among other diseases, to commit biological attacks on agriculture reservoirs and wells.17 It has been speculated that many countries, including the U.S., United Kingdom, Japan, France, Germany and the former USSR, had agricultural bioweapon programs at some point in the last several decades.18
It could be theorized that the ratification of the Biological and Toxin Weapons Convention in 1972, which prohibited the development and use of biological weapons by its member states, is a significant reason why there have been no documented instances of state actors conducting biological warfare using disease causing pathogens on U.S. livestock or crops in recent history.19 However, the rapid increase of technology and scientific literature available to the public can also provide terrorist organizations, and other agents with the intention of doing harm by inciting fear within a country’s infrastructure, with the means to create their own biological weapons.20 There have been instances in the U.S. where access to biological agents has enabled organizations to use pathogenic substances against the public food supply for political means, such as the 1984 attacks perpetrated by members of the Rajneesh cult who used salmonella typhi to poison the produce in several Oregon restaurants that led to illness in 750 people.21 Given the tumultuousness of the current global political climate and the increasing aggressiveness displayed by terrorist organizations against the
14 Andrienne Mayor, GREEK FIRE, POISON ARROWS, AND SCORPION BOMBS: BIOLOGICAL AND CHEMICAL WARFARE
IN THE ANCIENT WORLD (The Overlook Press, Peter Mayer Publishers, Inc.) 100–101 (2003). 15 Id. 16 Olson, supra note 13. 17 Tien-wei Wu, A Preliminary Review of Studies of Japanese Biological Warfare and Unit 731 in the United States (May 2014), http://www.zzwave.com/cmfweb/wiihist/germwar/731rev.htm. 18 Haralampos Keremidis et al., Historical Perspective on Agroterrorism: Lesson Learned from 1945 to 2012, BIOSECURITY AND BIOTERRORISM: BIODEFENSE STRATEGY, PRACTICE, AND SCIENCE 18 (2013). 19 Armin Elbers & Richard Knutsson, Agroterrorism Targeting Livestock: A Review with a Focus on Early Detection Systems, 11 BIOSECURITY AND BIOTERRORISM: BIODEFENSE STRATEGY, PRACTICE AND SCIENCE S25 (2013). 20 Keremidis et al., supra note 18, at S17. 21 Mark Wheelis et al. DEADLY CULTURES: BIOLOGICAL WEAPONS SINCE 1945 284–293, 301–303 (Harvard University Press 2006).
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U.S., the likelihood of violent non-state actors using agroterrorism as a means to incite fear and gain leverage cannot be underestimated.22
III. How Vulnerable is the United States Agriculture Sector?
Population increases taking place in most metropolitan and urban areas across the U.S. have played a significant role in the growth and concentration of larger agricultural operations, including farms and central processing plants, making food costs in the U.S. affordable.23 As the scale of these operations continues to grow rapidly in size, and intricacy, it becomes increasingly difficult and expen- sive to ensure the complete security of every facet in the supply chain; from cultivation to packaging for consumption, there are several points in the process which are vulnerable to the exposure of foreign materials and the possibility of adulteration.24 Large-scale meat and dairy producing operations will often uti- lize hormones, antibiotics, and other biotechnology on livestock for the pur- poses of promoting growth and increasing the welfare of the animals. However, some researchers believe that this may lead to weakening these animals’ immune system to foreign pathogens and cause more susceptibility to dis- eases.25 The close proximity of livestock, due to the current animal husbandry practices of many farms and feedlots, provide conditions that are ripe for exploitation by many communicable or highly contagious animal diseases.26
Under these conditions many analysts believe that the current food supply infrastructure makes the agricultural industry a key sector that remains excep- tionally vulnerable to the influence of harmful chemical or pathogenic substances.27
One hypothetical example frequently given is in the case of a potential agroterrorist attack involving Foot and Mouth Disease (FMD) on farmland inhabited by free-range cattle.28 The pathogen known to cause this disease
22 Keremidis et al. supra note 18, at S19-S20. 23 Monke, supra note 8, at CRS-5. 24 Peter Chalk, Hitting America’s Soft Underbelly: The Potential Threat of Deliberate Biological Attacks Against the U.S. Agricultural and Food Industry, RAND NATIONAL DEFENSE RESEARCH INSTITUTE 10, 14 (2004). 25 Parker, supra note 1, at 13. 26 Chalk, supra note 24, at 7. 27 See Id. at 7–17. 28 Elbers & Knuttsson, supra note 19, at S25–S26.
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(Aphthae epizooticae) is a virulent and fatal virus that is highly infectious among several ungulate and cloven hooved animals commonly used as livestock. An outbreak of Foot and Mouth Disease introduced to cattle in a region of unmo- nitored or minimally secured farmland, done with the intention of causing mass spread of infectious disease, would be catastrophic on many levels and not just limited to the direct loss of a number of livestock to the disease.29 A regional outbreak would require a significant amount of resources and collaboration of several local, state, and federal agencies to quarantine and euthanize infected and exposed animals to stop the spread of the disease, and the subsequent investigation of the attack. The fallout from a massive culling of livestock has severe implications on the international perception of the quality of meat products exported.30 A 1997 outbreak of FMD among swine in Taiwan is esti- mated to have cost around tens of thousands of dollars in direct losses, however the cost of disinfecting and “stamping-out” the disease is likely in the several billion-dollar range.31 In addition, the loss of export revenue from this disaster was estimated to be around 15 billion dollars.
IV. The Agroterrorism Effect on the U.S. Economy
The agriculture and food industry are significantly important to the quality of life in the United States.32 The agricultural sector alone is comprised of approxi- mately 2.1 million farms, 880,587 firms and 1,086,793 facilities, a majority of which are privately owned and altogether account for nearly one-fifth of the country’s economy.33 The FDA oversees approximately 600,000 restaurants, 235,000 grocery stores, and regulates a combined total of $255 billion in domes- tic and imported food.34 16% of the U.S. workforce is associated on some level with the food or fiber industry through farming, transport, or food service; and the contribution of these industries to the Gross Domestic Product of the country
29 Id. 30 Id. 31 P.C. Yang et al., Epidemiological Characteristics and Financial Costs of the 1997 Foot-and- mouth Disease Epidemic in Taiwan, 145 VETERINARY RECORD 731, 731–734 (1999). 32 See generally Jason Fearneyhough, The Importance of Agriculture Cannot be Undersold, WYO. DEP’T OF AGRIC., http://wyagric.state.wy.us/component/content/article/38-directors-office/264-the- importance-of-agriculture-cannot-be-undersold. 33 FDA, National Infrastructure Protection Plan: Agriculture and Food Sector (2007) http://www. fda.gov/downloads/Food/FoodDefense/ucm081287.pdf. 34 Id.
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is approximately 11%, or about $1.2 trillion in 2002.35 Food production is split evenly between crops and livestock; and productivity has increased over time allowing the amount of money consumers spend on food to account for only 10% of their disposable income.36 As most of the U.S. agriculture production is mainly concentrated in three specific regions of the country, which include the Midwest, parts of the east coast, and California, the consequences of a large- scale food contamination in just one area can rapidly disrupt the nation’s public health and economic stability.37
V. Federal Funding for Agroterrorism Preparedness
The federal government has made a significant investment in resources to ensure the quality and protection of the nation’s food supply. Post 9/11 appro- priations and user fees for homeland security operations in the USDA and Department of Homeland Security (DHS) related to agriculture have amounted to $818 million in 2007, which exceeds three times that of the prior amount before 9/11.38 In 2007, the agricultural industry accounted for 2.1% of the funding from the total non-defense budget for homeland security.39 Regular annual appropriations to the USDA for agroterrorism preparedness are often associated with initiatives like research grants or facilities, and have shown signs of steadily decreasing starting in 2006.40 The two agencies in the USDA and DHS receiving the most homeland security funding for agriculture are APHIS and U.S. Customs and Border Protection (CBP), accounting for 51% and 33% of the total funding in 2007, respectively.41 By comparison, funding for emergency preparedness and intelligence in these departments have received less funding. This is likely due to the view that the collecting of primary
35 USDA Nat’l Agric. Statistics Serv., 2002 Census of Agriculture (2004) http://www.agcensus. usda.gov/Publications/2002/USVolume104.pdf. 36 USDA, Food Pricing and Spending, http://www.ers.usda.gov/data-products/ag-and-food-sta- tistics-charting-the-essentials/food-prices-and-spending.aspx (last visited Mar. 29, 2015). 37 Monke, supra note 8, at CRS-5; see also US GOV’T ACCOUNTABILITY OFFICE, GAO-05-214, MUCH IS
BEING DONE TO PROTECT AGRICULTURE FROM A TERRORIST ATTACK, BUT IMPORTANT CHALLENGES REMAIN 10–11, 70–71 (2005). 38 Monke, supra note 8, at CRS-31-CRS-42. 39 Id. 40 Id. 41 Id.
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intelligence is more in line with the responsibilities of other federal investigative agencies like the FBI and CIA.42
VI. Congressional and Executive Response
In October 1999 the first congressional hearing concerning the topic of agroterror- ism, titled, “The Agricultural Biological Weapons Threat to the United States,” was introduced by Senator Pat Roberts; a member of the Subcommittee on Emerging Threats in the Senate Committee on Armed Services.43 It was not until a year after the events of September 11, 2001 that discussion of a terrorist attack on the nation’s agricultural industry was brought up by the legislature in 2002 with passing of The Homeland Security Act (P.L. 107–296, November 25 2002) estab- lishing the Department of Homeland Security, and the implementation of the Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107–188, June 12 2012). Further discussion about the topic of food defense occurred in November 19, 2003 when the Senate Committee on Governmental Affairs conducted an open hearing involving members of the administration, state governments, and private companies entitled “Agroterrorism: The Threat to America’s Breadbasket.”44 The Bioterrorism Preparedness Act included several provisions regarding public health and preparedness including many relevant to agriculture. These provisions included the Registration of Food Processors, requir- ing the FDA to create records and registration for all manufacturers and facilities that manage food.45 This registry gives the agency the authority and ability to track food that has been contaminated, however, these guidelines are not uni- versally accepted by those in the agricultural sector as completely efficient, due to the additional record keeping requirements and lack of proof that a facility will be able to respond in the event of an emergency.46
The Government Accountability Office (GAO) has produced several reports outlining the deficiencies in the nation’s agricultural security since the creation
42 Id. 43 The Agricultural Biological Weapons Threat to the United States: Hearing Before the S. Comm. on Armed Services Subcomm. on Emerging Threats (1999). 44 Agroterrorism: The Threat to America’s Breadbasket: Hearing Before the S. Comm. on Gov’tal Affairs, S. Hrg., 108–491 (2003) (statement of Sen. Susan Collins, Chairman, S. Comm. on Gov’tal Affairs). 45 Public Health Security and Bioterrorism Preparedness and Response Act, Pub. L. No. 107-188 (2002). 46 Monke, supra note 8, at CRS-14.
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of the Department of Homeland Security in 2002.47 Observations about certain points of security that required improvement according to the GAO included: better training for border inspectors,48 more documentation and increased enforcement of imported banned feed ingredients,49 strengthening the FDA’s authority to enforce requirements for standards at food processing facilities,50
and acknowledging vulnerabilities due to the low number of veterinarians trained to diagnose foreign animal diseases.51
On January 30, 2004 theWhite House established the “Defense of United States Agriculture and Food,” or Homeland Security Presidential Directive 9 (HSPD-9), creating a national policy to defend the agriculture and food sectors.52 Under this directive the Secretaries of the Department of Homeland Security, Department of Agriculture, Department of Health and Human Services, the Environmental Protection Agency, and the Central Intelligence Agency are to collaborate in the preparation, response, and recovery efforts that would be a consequence of an agroterrorist attack.53 In addition, these agencies must establish systems for the detection of diseases afflicting plants and animals, evaluating food quality, and promoting public health awareness.54 However, this presidential directive only concerns the management guidelines for these agencies and does not create enforceable public laws that would establish statutory guidelines for an agroterror- ism preparedness plan.55
The Strategic Partnership Program Agroterrorism Initiative (SPPA) was established in August 2005 to bring federal agencies (including the DHS, the USDA, the FDA, and the FBI) together with the state agencies and private
47 US GOV’T ACCOUNTABILITY OFFICE, GAO-04-259T, BIOTERRORISM: A THREAT TO AGRICULTURE AND THE FOOD SUPPLY (2003). 48 US GOV’T ACCOUNTABILITY OFFICE, GAO-02-808, FOOT AND MOUTH DISEASE: TO PROTECT LIVESTOCK, USDA MUST REMAIN VIGILANT AND RESOLVE OUTSTANDING ISSUES (2002). 49 US GOV’T ACCOUNTABILITY OFFICE, GAO-02-183, MAD COW DISEASE: IMPROVEMENTS IN THE ANIMAL FEED BAN AND OTHER REGULATORY AREAS WOULD STRENGTHEN U.S. PREVENTION EFFORTS (2002). 50 US GOV’T ACCOUNTABILITY OFFICE, GAO-03-342, FOOD-PROCESSING SECURITY: VOLUNTARY EFFORTS ARE
UNDER WAY, BUT FEDERAL AGENCIES CANNOT FULLY ASSESS THEIR IMPLEMENTATION (2003). 51 US GOV’T ACCOUNTABILITY OFFICE, GAO-05-214, MUCH IS BEING DONE TO PROTECT AGRICULTURE FROM A
TERRORIST ATTACK, BUT IMPORTANT CHALLENGES REMAIN (2005). 52 Department of Homeland Security (DHS), Homeland Security Presidential Directive/Hspd-9, Defense of United States Agriculture and Food (Jan. 30, 2004), available at http://www.fas.org/ irp/offdocs//nspd/hspd-9.html. 53 Id. 54 Id. 55 Monke, supra note 8, at CRS-22.
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industry.56 The purpose of this initiative is to conduct coordinated assessments of the food and agricultural sector with agricultural industry and state volun- teers as required by the National Infrastructure Protection Plan (NIPP), Sector Specific Plans (SSP), and HSPD-9 Defense of U.S. Agriculture and Food.57 These voluntary assessments are performed by industry representatives and Federal/ State agency government officials using the “CARVERþ Shock” guidelines.58
The C.A.R.V.E.R.þ Shock acronym is intended to be used as a method for identifying elements in the sector with the following attributes considered to be most open to exploitation and attack:59
– Criticality: The public health and the economic impacts of an attack; – Accessibility: Concerns the ease of getting in and out of a target area; – Recuperability: Concerns the capability to recover from an attack; – Vulnerability: The ability for an attack to happen on a target; – Effect: The consequences of an attack pertaining to loss in production; – Recognizability: Concerns how easy a target can be identified by a threat; – Shock: The combined health, economic and psychological impact.
These assessments helped to establish points of high concern, ways to improve communication between government and industry, and protective and control measures that would help diminish their vulnerability to potential problems.60
Issues concerning the improvement of communication channels and physical security for food processing facilities and disease surveillance for livestock were also addressed.61
The results of the SPPA assessments have identified general vulnerabilities dependent upon two sectors of the food industry: food processing and agricultural production. The points of highest concern for food products were those that involved the largest amount of product exposed to direct human contact, such as large batches of raw or mixed ingredients, and where the operation of this step involved the manual addition of ingredients.62 This suggested that reducing the amount of food product that has the potential to be intentionally adulterated was
56 USDA, STRATEGIC PARTNERSHIP PROGRAM AGROTERRORISM (SPPA) INITIATIVE: FIRST YEAR STATUS REPORT
(2005), available at http://www.usda.gov/documents/8-10-06%201%20yr%20report%20SPPA% 20agroter5.pdf. 57 Id. at 2. 58 Id. 59 USDA, CRITICAL INFRASTRUCTURE AND KEY RESOURCES SECTOR-SPECIFIC PLAN, (May 2007), available at http://www.fda.gov/downloads/Food/FoodDefense/ucm081308.pdf. 60 USDA supra note 56, at 11. 61 Id. at 6–11. 62 Id. at 6.
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of significant importance. The assessments also identified highly transmissible or contagious diseases as a key point of concern for agricultural products involving live animals and plants based upon the relative small amount required to cause a large impact on the country’s economy, and the possibility of zoonotic disease, or pathogens that can be transmitted from animals to humans, and their impact on public health.63 Mitigation strategies are another key component of the SPPA and these include site specific physical security measures, changes in food process design, inspection of raw materials, and employee peer monitoring.64
The Animal Enterprise Terrorism Act implemented in 2006 addresses the criminal repercussions associated with the damage or interference of animal enterprise operations.65 This act more explicitly defines the penalties for attacks on animals related to the agricultural or food producing industry and specifi- cally mentions vandalism, criminal trespass, harassment, and property damage as punishable activities. This act increases the scope of the law to include acts perpetrated by ecoterrorist and bioterrorist threats.66
On January 4, 2011 the FDA Food Safety Modernization Act (P.L. 111–353) was signed into law, and allows the FDA to protect public health through an increased emphasis on the security of the nation’s food supply.67 The guidelines specified in this act are to help the FDA to be more proactive in the prevention of hazards in the food supply; rather than reacting to problems that have already occurred.68 Providing the administration with enforcement authority to ensure compliance with new safety standards and improve their response to mitigate problems that arise is one step in this process.69 In addition to establishing methods to assess the safety of imported foods and establish a network of state, local, and territorial authorities. Section 103 specifies that the FDA is to produce regulations and requirements for facilities that manufacture, process, pack, or hold food, with regard to how possible hazards could be introduced through acts of terrorism. Section 106 of the FSMA states that the FDA is to issue regulations to protect parts of the food sector that are considered high risk or particularly susceptible to intentional contamination that could significantly impact public health to humans or animals. Section 105 specifies what the
63 Id. 64 Id. at 7. 65 Animal Enterprise Terrorism Act, Pub. L. No. 109-374 (Nov. 27, 2006). 66 Id. 67 Food Safety Modernization Act Pub. L. No. 111-353 (Jan. 4, 2011). 68 FSMA Facts Background on the FDA Food Safety Modernization Act, FDA (June 2011), http:// www.fda.gov/downloads/Food/GuidanceRegulation/UCM263773.pdf. 69 Id.
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FDA does to issue science-based minimum standards for the harvesting and production of produce with consideration for intentionally introduced hazards.
In previous proposed rules concerning current good manufacturing practice, hazard analysis and risk-based preventive controls for human food, the FDA did not include any measures to address hazards that are introduced intentionally.70
Sections 103 and 105 were implemented separately to address hazard issues, but the FDA decided that intentional adulteration of food that does not fall under the Hazard Analysis and Critical Controls Point, or other food safety mechan- isms, should require different regulations.71 However, the new proposed rules do not apply to cattle feed yards or feed mills if they do not produce and provide feed outside of their operation.72
In December 2013 the Food and Drug Administration proposed new regula- tions for foreign and domestic food facilities to register under the Federal Food, Drug, and Cosmetic Act (FD&C) (P.L. 75–717), a federal law enacted by Congress to establish the legal framework for which the FDA operates and develops regulations to deal with the threat of introducing hazardous materials through acts of terrorism. Under the FD&C Act food facilities would be required to have guidelines in place to mitigate, significantly minimize, or fix any vulnerabilities in the process of food production.73 These rules are proposed by the FDA as part of the implementation of the Food Safety Modernization Act (FSMA). Before the passage of the FSMA, food producing and preparation facilities did not have any requirements for implementing guidelines or strategies for food defense against intentional contamination.74 Deadlines are set requiring the FDA to issue reg- ulations for provisions in the FSMA.
VII. Food Security Inspection and Compliance
Regulations and guidelines for food security inspection procedures related to agriculture fall under the federal jurisdiction of the United States Department of Agriculture (USDA). In response to the threat of agroterrorism, the USDA has established protective programs managed by individual agencies within the
70 Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, 78 Fed. Reg. 24 (Dec. 2013). 71 Id. 72 Texas Cattle Feeders Association. FDA Produces New Regs; Most Commercial Feedyards Not Affected, TEX. CATTLE FEEDERS ASS’N NEWSLETTER 1 (Nov. 2013). 73 HHS, supra note 70, at 1. 74 FDA, supra note 68, at 1.
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department that concentrate on safeguarding livestock and crops from outbreaks of disease and pest infestations to ensure the safety of fiber, meat, poultry, and egg products.75 There are several diagnostic laboratories in this sector that fulfill a key role in this effort, such as: The National Animal Health Laboratory Network (NAHLN), the Food Emergency Response Network (FERN), and the National Plant Diagnostic Network (NPDN). These laboratories provide diagnos- tic testing for the identification of animal and plant pathogens, as well as contaminants in food products.76 The USDA is also a member of the national Integrated Consortium of Laboratory Networks (ICLN), which represents the framework that coordinates laboratory networks across all federal agencies and is overseen by the Department of Homeland Security Joint Leadership Council (JLC).77 The purpose of the ICLN is to harness the capabilities of each agency, and the Departments of Defense, Agriculture, Energy, and Health and Human Services, to produce quick results necessary for the detection and management of a response to a terrorist attack.78
Border inspections are the most significant homeland security activity for agriculture, accounting for much of the USDA Animal Plant Health Inspection Service activities.79 Inspection of all agricultural products at the border is a joint operation conducted by APHIS and the Customs and Border Patrol Agency.80
Activities relating to border inspections are mostly funded by user fees rather than appropriations, of which 39% is retained by APHIS with the remaining amount transferred to the Department of Homeland Security for the CBP.81
In 2006, the USDA released the pre-harvest security guidelines and check- list, a voluntary checklist created to provide landowners and farmers with a resource for preventing security risks.82 Awareness of signs of suspicious activ- ity, developing a risk management plan, and creating barriers around facilities are a few of the recommendations the USDA suggests farm owners follow for general planning. Production specific checklists for dairy, cattle, and crop
75 USDA, supra note 59, at 13–14. 76 2011 Sector Critical Infrastructure Protection Annual Report for the Food and Agriculture Sector, U.S. DEP’T OF AGRIC. 76–80 (2011) http://www.fda.gov/downloads/Food/FoodDefense/ UCM348809.pdf. 77 INTEGRATED CONSORTIUM OF LABORATORY NETWORKS, https://www.icln.org/ (last visited March 29, 2015). 78 Id. 79 Monke, supra note 8, at CRS-34. 80 Id. 81 Id. 82 Pre-Harvest Security Guidelines and Checklist 2006, U.S. DEP’T OF AGRIC. (March 2006), http:// www.usda.gov/documents/PreHarvestSecurity_final.pdf.
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security focus on expanding security, identification, and record keeping of animals and enforcing routine monitoring and maintenance of facilities.83
The FDA also has guidelines relevant to the inspection and compliance of food producing facilities. The FSMA includes provisions requiring increased inspections and more inspections based on risk.84 The legislation requires that high-risk domestic food facilities must be inspected within five years of the act’s implementation and at minimum once every three years.85 All other domestic food facilities not considered high risk must be inspected within seven years of the acts’ implementation and at least once every five years after.86 The FDA regular inspection of foreign food facilities will also increase and will take place at minimum once a year every five years.87 Provision FSMA103/FDCA 418 requires that certain records be stored for a minimum of two years. Section 204 of the FSMA calls for the FDA to require additional recordkeeping for high- risk foods for the purpose of quicker and more effective tracking of foodborne illness during an outbreak.
The regulations proposed under the FSMA would better implement three provisions of the FD&C that correspond to the intentional contamination of food; Section 418 corresponds to the manufacture, process, pack, or holding facilities that are required to register under Section 415. Section 419 involves the inten- tional adulteration of fruits and vegetable that are raw agricultural commodities. Section 420 involves the intentional adulteration of high-risk foods and exempts farms with exception of those that produce milk. The FDA determines high-risk foods by collaborating with stakeholders and observing what areas in the supply chain that are most vulnerable to intentional contamination in order to figure out methods for control.88
On October 25, 2013 the FDA proposed the Preventive Controls for Animal Food Rule, under the FSMA, to set new regulations for the holding of animals, as well as the manufacturing, processing, and packing of animals for food.89
The rule would establish new Current Good Manufacturing Practice guidelines for improving the hygiene and design of facilities involved in the processes of food production. In addition, new measures regarding preventive controls to be implemented from section 103 of the FSMA include the requirement for facilities
83 Id. 84 P.L. 111–353 supra note 67. 85 Id. 86 Id. 87 Id. 88 Id. 89 FDA Issues Proposed Rule under FSMA to Improve Safety of Food for Animals, U.S. FDA (Oct. 25, 2013), http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm372128.htm.
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to do a hazard analysis, have a food safety plan, and create controls to prevent hazards and monitor these controls to determine their efficacy.
VIII. How Is the Texas Animal and Health Commission implementing Federal and State Government Agroterrorism Guidelines?
The agricultural industry of Texas is one of the most significant in the United States, leading the nation in cattle, cattle feeding, cotton, hay, sheep, and wool, and producing a significant amount of dairy and swine related animal pro- ducts.90 In 2010 the state contained 247,500 farms and ranches occupying 130.4 million acres, with one in seven citizens involved in the agricultural industry.91 Exports of agricultural products are estimated to have exceeded $6 billion.92 Texas is the largest supplier and producer of beef among all states in the U.S., accounting for approximately 14.5% of the country’s cattle popula- tion.93 The combined dairy industries of New Mexico and Texas make this area the third largest milk-producing sector in the country.94 The geographical loca- tion of the state and its borders with Mexico also pose a great concern as Texas imports an estimated one million cattle per year from Mexico, and over two million cattle interstate, and it is believed that many more animals cross the borders undetected.95 The impact of an outbreak of highly infectious disease, such as Foot and Mouth, in this region would have significant consequences on the economic stability of the region as well as the larger cattle industry and food import and export business.96 Prevention of a biological attack on crop or livestock in the region is difficult given the scope of the agricultural operations,
90 The Texas Economy, NETSTATE, http://www.netstate.com/economy/tx_economy.htm (last visited March 29, 2015). 91 Tex. Animal and Health Comm’n, 2013–2017 Agency Strategic Plan, TEX. ANIMAL AND HEALTH
COMM’N (June 2012), http://www.tahc.state.tx.us/agency/TAHC_Strategic_Plan_2013-2017.pdf [hereinafter TAHC]. 92 Id. at 5. 93 Id. 94 Id. 95 See id. at 8. 96 Monica Giovachino et al., Operation Palo Duro: Policy and Decision-making in Response to an FMD Outbreak, THE CNA CORPORATION (May 2007), http://www.tahc.state.tx.us/emergency/ May2007_OperationPaloDuro.pdf.
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making complete defense of food products a huge logistical undertaking; there- fore much of the commission’s efforts are focused on mitigation through sur- veillance and controlling disease outbreaks as they occur.97 Unintentional and intentional disease outbreaks of infectious disease, such as brucellosis, among cattle within Texas have been and remain a large concern with regards to possible exploitation by agroterrorism.98 As the role of the Texas Animal Health Commission in protecting this sector is significant, examination of the current guidelines created by the commission warrant exploration.
The Texas Livestock Sanitary Commission was established in 1893 in order to respond to problems associated with the Texas fever tick epidemic threaten- ing the state’s cattle industry.99 The agency was renamed the Texas Animal Health Commission (TAHC) in 1959 and has since worked to safeguard the health of all animals used as livestock and affiliated with food production in the state Texas; ensuring a safe supply of products such as meat, eggs, and dairy. The TAHC is also given legislative authority by the state, through the Texas Agriculture Code, to create and enforce regulations necessary for the prevention, control, and eradication of communicable disease that have the ability to harm livestock and human health.100 These regulations are made through the collaboration of thirteen commissioners appointed by the governor to represent the livestock industry and the general public. The TAHC head office is based in Austin, TX and is supported by seven regional offices around the state to work closely with ranchers, animal husbandry workers, and other industry personnel to identify and respond efficiently to issues that arise. In addition, the commission has laboratories to perform serological and microbio- logical diagnostic services for detecting harmful biological pathogens that threa- ten livestock.101 As the TAHC is the primary organization overseeing animal livestock in the state of Texas, the agency works very closely with other state and federal agencies overseen by the USDA, which include: the Animal Plant Health Inspection Service/Veterinary Service, Agricultural Research Service, Texas Department of Agriculture, and Natural Resources Conservation Service.102 The Code of Federal Regulations (CFR) Uniform Methods and Rules
97 TAHC, supra note 91, at 9–10. 98 Texas is Cattle Brucellosis “Bangs” Free: What Producers Need to know about Texas’ Brucellosis “Free” Status, TEX. ANIMAL AND HEALTH COMM’N (Oct. 2012), http://www.tahc.state.tx. us/news/brochures/TAHCBrochure_Brucellosis.pdf. 99 TAHC, supra note 91, at 5. 100 Statutes & Rules, TEX. ANIMAL AND HEALTH COMM’N (2013), http://www.tahc.state.tx.us/regs/ code.html. 101 TAHC, supra note 91, at 6. 102 Id.
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specifies the USDA requirements for each state regarding disease control and eradication, and the federal agency can impose movement restrictions on ani- mals in the state if the minimum requirements are not met.103 In addition to its federal cooperation with USDA-APHIS regulations, the TAHC authority for the control and eradication of diseases among animals is outlined in the Texas Agriculture Code, chapters 161–168.
In 2004, the USDA began implementing the National Animal Identification System (NAIS) as a significant measure to protect animal health. The purpose of the system is to facilitate the fast trace of animals or livestock exposed to harmful pathogens in the event of a disease outbreak within 48 hours of discovery. Under these guidelines most livestock animals including sheep, goats, swine, bison, and cattle, among others, should be given a unique identi- fication number and in the case of bovine, some form of electronic identification ear tag.104 The goal of these measures is to facilitate an ideal rapid response that will reduce both the economic and public health impact caused by an out- break.105 The main components of NAIS are: premises Identification of locations where animals or livestock are maintained; identification of each individual animal through the use of numbers and tags; and maintaining quick and accurate records concerning animal movement.106
While the identification system is voluntary, state agencies have been encouraged to implement the program with federal funding.107 However, due to concerns expressed by independent farmers regarding the increased cost and resources required to meet these guidelines for every individual animal, the USDA announced its intentions to revise its initial plans for the NAIS in favor of a new framework to trace animal livestock in 2010.108 Under the USDA-APHIS final rule, effective March 11, 2013, all livestock species specified in the amended regulations, including cattle that are transported across states, must have some official identification along with an interstate certificate unless specifically exempted.109
103 TAHC, supra note 91, at 37. 104 USDA, National Animal Identification System (NAIS)—A User Guide and Additional Information Resources (Dec. 2007), http://farmandranchfreedom.org/wp-content/uploads/2013/ 01/usda-nais-user-guide-december2007.pdf. 105 Id. 106 Id. 107 Judith McGeary et al., Position Statement Opposing the National Animal Identification System, Farm and Ranch Freedom Alliance (Feb. 5, 2013), http://farmandranchfreedom.org/ animal-id/national-animal-id-system/. 108 Id. 109 9 C.F.R § 71, 77, 78, and 86.
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In conjunction with the regulations issued by the USDA and outlined in 9 CFR part 86, the Texas Animal Health Commission has established its own rules regarding identification and traceability requirements for cattle. House Bill 1361 was passed and signed into law during the 79th Texas Legislative Session which allows the Commission to create and implement an animal identification system similar to the NAIS.110 Under 43.2(n) of the Texas Administrative Code, all dairy cattle that are transported within the state of Texas must have some form of the official identification device approved by the commission.111 In 2013, the TAHC proposed new rules for animal disease traceability that more closely follow the USDA regulations outlined in 9 CFR 86. These rules require that all cattle that are parturient or post parturient or 18 months of age and older that change ownership within Texas must have some form of official commission approved identification.112 TX H.B. 2311, which was signed into law on May 25, 2013, states that the Texas animal disease traceability program cannot be stricter than the guidelines of the federal government and repeals provisions giving the TAHC Class C misdemea- nor authority for violations pertaining to animal identification.
IX. TAHC Emergency Response Plan
In collaboration with the USDA, its sub-agencies, and local state authorities, the Texas Animal Health Commission (TAHC) works under the implementation of both the “USDA/APHIS Highly Contagious Disease Plan” and the “State of Texas Emergency Management Plan” to layout the operation and responsibilities of parties involved in the preparation and response to any highly contagious animal disease affecting Texas Livestock.113 The Emergency Management Council is made up of various representatives of state agencies to assist the Governor of Texas in all matters concerning disaster preparedness, response, and recovery. The Executive Director follows the State Emergency Management Plan, oversees the commission regarding its use of resources in response to an emergency, and reports to the Governor.
The government response to an agroterrorism event is different from the response to other potential or natural disasters, as the chain of response starts
110 TX H.B. No. 1361. 111 4 TEX. ADMIN. CODE § 43.2. 112 Id. at §50.3. 113 State Plans, TEX. ANIMAL HEALTH COMM’N, http://www.tahc.state.tx.us/emergency/stateplans. html [hereinafter TAHC].
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locally and is overseen at the state and federal level.114 The response to a biological attack on agriculture starts at the local level, where farmers or workers first identify sick animals among their livestock and seek assistance from a county agricultural extension agent and veterinarian. These personnel will contact the United States Department of Agriculture (USDA) or the Texas Animal Health Commission (TAHC) if a highly contagious disease of concern is suspected.115 A USDA trained state foreign animal disease diagnostician capable of performing a clinical evaluation and preparing samples for laboratory testing quickly examines sick animals.116
The diagnostician classifies the likelihood of the area having a highly contagious disease ranging from “unlikely” to “highly likely,” they will notify the directors of the TAHC and the area veterinarian in charge for the USDA for the state.117 In the case of a high likelihood of disease in the area, local measures are quickly put into effect for damage control and reduce any severe issues that arise as a result of further disease transmission leading to an outbreak. Samples taken from infected livestock can be sent to Plum Island Animal Disease Center in New York where the USDA and APHIS laboratories are located and where foreign animal disease diagnosticians are trained, or to USDA/APHIS laboratories in Ames, Iowa.118
The samples are given designated priority levels to determine how quickly they are processed and tested for the presence of pathogens. If a specimen has been tested as positive for a pathogen then the diagnostician contacts the state veter- inarian and USDA area veterinarian in charge, as well as the FBI and OIE if demanded by the situation.119 If the event appears to be isolated, the FBI may also be contacted by local farmers, the county or state extension agent, or a sheriff. If the cause for a potential outbreak is considered to be the result of an agroterror- ism event and is declared so at the state and federal level, then the FBI acts as the lead federal investigative agency and collaborates with the local and state agencies to oversee and carry out the investigation.120 Once the state emergency manage- ment response is implemented, the TAHC and USDA are responsible for managing any animal related issues in collaboration with county and state level agencies.
114 Id. at O-3-4-O-3-24. 115 Id. 116 Id. 117 Id. 118 See Id. 119 See Id. 120 USDA, Criminal Investigation Handbook for Agroterrorism, 37–42 (2008), http://www.fsis. usda.gov/wps/wcm/connect/c3ca6715-f7d4-46be-8ae1-f94be7e83786/Investigation_Handbook_ Agroterrorism.pdf?MOD=AJPERES.
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While the TAHC has authority to determine the movement and transportation of animals only, it is the duty of law enforcement to monitor and determine the movement of people.121 Preparedness and planning for law enforcement personnel will need to be developed at the local level.
When a highly contagious disease outbreak has been confirmed, a stamp- ing-out policy is put in motion.122 With the authority of the Veterinary Administration, all animals that are affected by disease, or suspected to have been exposed to disease causing pathogens, are to be killed and the remains burned or buried to prevent the further spread of disease.123 The stamping-out policy can be altered to allow for the use of vaccination without the need for mass euthanization of herds and culling.124
The USDA and TAHC address several operational components to eradicate highly infectious diseases, including quarantine, epidemiology, euthanasia, and disposal, with the outcome of establishing a control area of infected and buffer regions surrounding an outbreak.125 In order to facilitate the investiga- tion of a possible spread of disease among livestock, the state of Texas Agriculture Code Section 161.049 requires records and documentation of all livestock sales with details including names of buyer and sellers and the country origin. The Executive Director of the TAHC has the authority to estab- lish a quarantine on disease affected animals or locations, require testing, vaccination, or another epidemiologically sound procedure to permit move- ment of livestock, require the slaughter of livestock exposed to a disease; in the case of the latter, owners may also be compensated.126 In addition, a representative of the TAHC has the ability to stop and inspect a shipment of animals or products in the state.127
The Texas Animal and Health Emergency Response Requirements are outlined in Title 4 of the State of Texas Emergency Management Plan and outlines how the TAHC assists local jurisdictions through the state emergency management system by performing animal needs assessments, coordinating disposal activities, and addressing evacuation and sheltering issues through various resources and partnerships. To coordinate the planning, the response,
121 Glenn Schmitt, Agroterrorism—Why We’re Not Ready: A Look at the Role of Law Enforcement, NAT’L INST. OF JUST. J. 257 (Dec. 2006). 122 Giovachino supra note 96, at 18–32. 123 Id. at 22–23. 124 Id. at 29–30. 125 TAHC, supra note 113. 126 4 TEX. ADMIN. CODE § 58.11. 127 Id. at § 58.211.
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and recovery, which is necessary to protect livestock regarding concerns that are not disease related, the TAHC also assists and directs different organiza- tions before, during, and after disasters according to the State Animal Response Plan.128
X. The Future Role of the Texas Animal Health Commission in Protecting against Agroterrorism
By continuing to work closely with the USDA-APHIS-VS on matters of agriculture protection from potential agroterrorism, the Texas Animal Health Commission is putting considerable effort into preparedness for intentional and unintentional disease outbreaks among livestock in the state. The TAHC supports the imple- mentation of the federal National Animal Identification System (2013) for track- ing animal movement and has been preemptive in their own state requirement for electronic ear-tag identification among cattle.129 Through practicing the agency’s response efforts in simulated highly contagious disease outbreaks, as seen in Operation Palo Duro, and implementing the Foreign and Emerging Animal Disease Response plan, measures to control and eradicate disease out- breaks before they become a larger concern are in place. The commission’s current priorities from 2012 through 2017 are to increase its efforts regarding emerging disease surveillance, bring these programs up to national standards, further its collaborations with industry to support the implementation of animal disease traceability across the state, and continue the development of its emer- gency management and homeland security responsibilities.130
128 DEE ELLIS, TEXAS ANIMAL HEALTH COMM’N, ANIMAL RESPONSE PLAN FOR NON-DISEASE, ANIMAL-RELATED EVENTS, (2008), available at http://www.tahc.state.tx.us/emergency/Appendix6AnimalResponse Plan.pdf. 129 4 TEX. ADMIN. CODE § 43.2, supra note 111. 130 TAHC, supra note 91, at 46.
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