1 Communication

2 A 21st Century Analysis of Sustainable and Conventional Agriculture using the

3 Food Safety Modernization Act of 2011

4 Megan Damele 1

5 1 Affiliation 1; dame7744@vandals.uidaho.edu

6 Abstract: The increase in scale of modern agriculture is a result of governmental incentive,

7 biotechnology advancements, and a cultural change within the United States. A nonlinear result of
8 the increase in overall scale of agriculture production including processing, globalization, and
9 importation is an increase in cases of pathogenic foodborne illness. The Food Safety Modernization
10 Act was created to mandate prevention plans and recall procedures for large-scale food industries
11 primarily, but does affect small-scale farms as well. The Act is revolutionary in several ways. First,
12 it is an overhaul of the food industry in the United States as it creates consistency of testing, recall
13 procedure, and auditing and inspection for food industries. Second, it nontypically grants freedoms
14 to small-scale agriculture and does not favor large-scale, or conventional, agriculture. Finally, the
15 Act will prompt an increase of traceability throughout the entire chain of food production and may
16 subsequently seek to remedy many environmental practices commonly used by conventional
17 agriculture, including soil degradation and application of synthetic chemicals.

18 Keywords: Food Safety Modernization Act 1; Sustainable Agriculture 2; Farm-to-Table Agriculture

19 3 Conventional Agriculture 4;

20

21 1. Introduction
22 As is well known, the food system within the United States is primarily industrial. As our
23 technological level increases, so does the scale of our farms and processing plants and the size of our
24 equipment and fields. But what has not grown proportionally with our food system is our food safety
25 standards or our care for the environment. Food industries will typically sacrifice quality of soil,
26 closed-cycle farm systems, health of consumers, and safety of their product for economic gain. There
27 is evidence of this in the pollution of air and water downstream of industrial agriculture plants,
28 microbial levels in the soil, and the overall health due to cheap food choices in the United States. The
29 farming method of small-scale, sustainable, holistic, or ‘Farm-to-Table’ agriculture is widely
30 considered to be more sustainable for several reasons. These farms are typically diverse and grow
31 crops as well as raise animals. Need for use of synthetic chemicals is less due to the checks and
32 balances of a closed-cycle system. And finally, food is typically sold directly to consumers and not
33 processed and is therefore considered more nutritious. As the scale of production has increased since
34 the industrial revolution, the scale of food safety has consistently lagged. This is evident in the
35 number of foodborne illness outbreaks in the U.S. and the health costs associated with these illnesses.
36 A small-scale agriculture approach has similar risks of pathogenic contamination, but as the radius
37 of distribution and scale is smaller, so is the number of people affected. The Food Safety
38 Modernization Act of 2011 (FSMA) has implications regarding new regulation of the entire food
39 industry and has differing regulations depending on scale of business. FSMA promotes neither
40 method of agriculture but is revolutionary in its way of redesigning industrial agriculture yet still
41 allowing sustainable, smaller-scale agriculture to remain a significant source of community,
42 economy, and nutrition in a growing number of communities in the U.S. Developed in this paper is
43 a brief history of agriculture in the United States, policy regarding sustainability and food safety

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44 preceding the Food Safety Modernization Act, roles of both large-scale (also referred to as
45 conventional, industry, or industrial-scale) and small-scale (also referred to as small farm,
46 sustainable, holistic, or sustainable agriculture) in the food system in the United States and in the
47 general scheme of sustainability. Finally, the potential decrease in synthetic inputs of industrial
48 agriculture will be discussed due to increased traceability mandated by the Food Safety
49 Modernization Act.

50 2. Discussion

51 2.1. History of Food Recalls

52 The increase in food borne illness outbreaks can be explained in several ways. First, the increase
53 in technology has allowed traceability that was once impossible. Because of the globalization of
54 agriculture, it is important to be able to follow an illness, an outbreak, and the source of contamination
55 to its source. This increase in traceability has allowed for more accurate numbers and representations
56 of illness that was previously unavailable. Second, the United States imports a significant amount of
57 produce from other countries. These countries often do not have food safety standards or even a
58 means of pathogenic testing, and prior to FSMA, a significant amount of produce entering the United
59 States remained untested. Finally, the scale of production and processing of food within the U.S. has
60 outgrown the ability for companies to test it in its entirety. Even with the food safety testing standards
61 in the U.S. today, between October 1st and October 13th, 2018, there were four food recalls for Listeria
62 monocytogenes in products ranging from “Country Ham Rolls” to “No Sugar Added Ice Cream”,
63 according to the FDA recalls website. [1]. Products are recalled for reasons including but not limited
64 to: “Lack of Sterility Assurance”, “Salmonella”, “E. Coli”, and “Microbial Contamination”. These
65 recalls affect all within the food system, including the farmer, processor, retailer, and consumer. Not
66 only do these recalls undermine consumer trust in food brands, they negatively affect health and can
67 even be deadly. The CDC estimates that: “Each year in the United States an estimated 9 million people
68 get sick, 56,000 are hospitalized, and 1,300 die of foodborne disease caused by known pathogens” [2].
69 Hoffman et. al estimates that 14 of the most common foodborne illnesses cause $14 billion in cost of
70 illness, and of this $14 billion, 90% is due to either nontyphoidal Salmonella enterica ($3.3 billion),
71 Campylobacter spp. ($1.7 billion), Listeria monocytogenes ($2.6 billion), Toxoplasma gondii ($3
72 billion), and norovirus ($2 billion) [3]. Pathogenic contamination occurs in small- and large-scale
73 agriculture alike, but because of the scale, industrial agriculture affects the health of significantly
74 more people. With the globalization of agriculture, recalls can affect people across the entire world.
75 Recalls are also economically and environmentally costly to industry, retail, and farmers alike. It does
76 depend, however, on the sector of industry (type of product), seriousness of problem, and magnitude
77 of people affected. But regardless, recalls have negative influence on brand power which damages
78 reputation and can affect market value as well. As the disconnect between food and grocery store
79 shelves widened, it became evident that change was necessary if the situation were to be remedied.
80 This change came in the form of policy and regulation in response to a broad coalition of stakeholder,
81 including consumers, farmers, and industry professionals.

82 2.2 Policy Preceding the Food Safety Modernization Act

83 The first enacted policy in the United States regarding food consumption was the Pure Food and
84 Drug Act and the Meat Inspection Act in 1906. This law addressed marketing of imports and exports,
85 food adulteration, and processing. Preceding this law was the technological advances of railroads,
86 which provided transportation of goods, refrigeration, which extended shelf life, and mechanized
87 processing systems, partially eliminating human interaction. [4]. Primary policy in place prior to the
88 Food Safety Modernization Act was Hazard Analysis of Critical Control Points (HACCP). HACCP is
89 a globally adopted food standard that focuses on the importance of process controls. HACCP
90 identifies areas along the chain of food production that could potentially be at risk for contamination
91 and requires steps to reduce (often kill) potential contaminants. These are called critical control
92 points, and in the U.S. an effective plan for maintaining critical control points must be in place in
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93 every food facility, primarily those who create RTE (Ready to Eat) products. The concept of critical
94 control points is the same in the FSMA, except the term is changed to “processing controls”. Another
95 applicable policy preceding FSMA is the Farm Bill of 1990. The Farm Bill defines sustainable
96 agriculture, and many advocates for a resurgence of small-scale agriculture campaign for an
97 amendment to FSMA that supports sustainable agriculture as described by the Farm Bill as
98 an integrated system of plant and animal production practices that will satisfy
99 human food needs; enhance environmental quality and the natural resource base
100 upon which the agricultural economy depends; make efficient use of renewable
101 resources and on-farm resources, and integrate natural biological cycles and
102 controls; sustain the economic viability of farm operations; and enhance the quality
103 of life for farmers and society [5]
104 The Food Security Act of 1985 is a primary reason for the shift towards industrial agriculture.
105 This Act supported the prices of milk, wheat and grain feeds, cotton and rice from 1986-1990. This
106 governmental support incentivized a drastic increase in production by eliminating the fear of market
107 pricing and competition. In response to the governmental support of Industrialized agriculture, The
108 Sustainable Agriculture Adjustment Act of 1989 encouraged adoption of sustainable agriculture. The
109 first method described for attaining sustainability is the following: “reducing existing program
110 barriers to the adoption of alternative sustainable agricultural production systems” [6]. The bill also
111 provided education, financial assistance, evaluation techniques, and incentives for integrating the
112 best management practices. These bills provide a brief outline of prior policy that initiated the growth
113 of agricultural practices which led to issues in food safety, subsequent bills, and finally, the Food
114 Safety Modernization Act we have today.

115 2.3. Requirements of the Food Safety Modernization Act

116 The overall goal of the act is to prevent foodborne illness-causing pathogens, such as Escherichia
117 coli O:157 H:7, Salmonella spp., and Listeria monocytogenes. [7] There are several aspects of the bill,
118 including a mandatory Food Safety Plan, increased authorization of FDA to oversee farm and plant
119 activities, and requirements in addition to the previously followed HACCP plan. Preventative
120 controls now may be required in points along the process in additional to critical control points.
121 Specific targets for preventative control include: processing risks, food allergens, and sanitation, and
122 recall plans. FSMA requires a Food Safety plan for every facility affected. These plans must include
123 the following:
124  Hazard analysis
125  Preventive controls
126  Supply‐chain program
127  Recall plan
128  Procedures for monitoring the implementation of the preventive controls
129  Corrective action procedures
130  Verification procedures
131  Records [8]
132 Additionally, the FDA has the authority to set standards of safety in production of produce,
133 including fruits and vegetables. This is including in the Produce Safety Final Rule, which takes into
134 account the number of days between chemical application and harvest [9]. FSMA will also give the
135 FDA the authority to prevent chemical, biological, radiological, and/or nuclear contamination. This
136 means the FDA will have the ability to conduct on-site evaluations and audits, which increases the
137 accountability of all areas of industry involved. FSMA grants the FDA access to records as well. In
138 addition to requiring processing controls, the FSMA also requires allergen preventive controls,
139 sanitation preventive controls, and supplier controls.

140 2.4. Small Scale Agriculture and Sustainability

141 Small-scale agriculture was the primary form of economic activity for much of the pre-
142 industrialization era. Kerber says, “before World War II, 24 percent of Americans were employed in
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143 agriculture-compared to 1.5 percent today.” The amount of people involved in small scale agriculture
144 has significantly decreased, and so has their impact on our food system. Now, small-scale agriculture
145 accounts for 91% of farms in the United States but only 23% of food production. [10] This method of
146 agriculture can be referred to as organic, holistic, or sustainable, but the basis is similar. Smaller scale
147 agriculture typically includes a diversity of plants and animals, minimal use of synthetic fertilizer,
148 pesticides, and herbicides, and is accompanied by a local community of buyers and sellers. Smaller
149 scale agriculture, though typically considered less efficient, is more efficient when a polyculture is
150 considered. For example, as stated by Altieri:
151 A large farm may produce more corn per hectare than a small farm in which the corn
152 is grown as part of a polyculture that also includes beans, squash, potatoes, and
153 fodder. But, productivity in terms of harvestable products per unit area of
154 polycultures developed by smallholders is higher than under a single crop with the
155 same level of management.
156 Due to the diversity of their production, small scale farms are also more resistant to crop failure,
157 market failure, and changes in global climate. [11] Another aspect of small-scale agriculture is the
158 culture of passion and love farmers have for the land. Farming as a way of life is symbolic of the idea
159 that if one takes care of the environment, so will the environment take care of them. This culture is
160 typically specific to small scale agriculture. Small scale agriculture faces problems typical of many
161 small businesses within the United States, including: lack of management, capital, high start-up cost
162 and long-term payoff range, and degraded soils. [12]Prior to the industrial boom, small farms would
163 utilize other farms resources as well as their own. Communities would help each other in lending
164 equipment, labor, or capital. Today, however, with the scarcity of small-farms, there is typically no
165 local resource base to utilize. All equipment and labor must be provided by the farm itself, and this
166 is costly and often the primary barrier to the success of sustainability farming.

167 2.5. Impact of the Food Safety Modernization Act on Small Scale Agriculture
168 FSMA recognizes importance of small-scale agriculture on the culture of a community, soil,
169 biodiversity, and water conservation, and the economic sector of the U.S. FSMA also recognizes the
170 potential economic burden the act would unnecessarily instill on these businesses. Monetarily, the
171 FDA estimates that cost of compliance for small farms would be 6% of annual food sales for farms
172 who make less than $250,000 in food sales yearly. In contrast, the cost of compliance for large scale
173 operations would be 1% of their annual food sales.[13] For this reason, FSMA has exceptions for
174 smaller-scale farms. If the farm generates less than $500,000 for a period of three years and sells more
175 than half of their outputs to qualified end users, they are exempt under the Tester-Hagan
176 Amendment.[10], [14] The FDA has estimated that roughly 71,000 farms within the United States fall
177 into this category. [15]This means small-scale, organic, and sustainable agriculture do not have to
178 follow the strict regulations that large-scale industry does. Not only does this provide a favorable
179 context for raising more sustainable and environmentally responsible agriculture, it doesn’t penalize
180 those already doing so. However, though the risk of pathogenic contamination on said smaller farms
181 is less due to scale, exemption from FSMA regulation does not exempt the entity from liability. For
182 this reason, many small-scale farms are required to obtain a certification such as Good Agriculture
183 Practices. Many small-scale farms sell directly to restaurants, schools, or small organizations, and
184 though the risk of contamination is less, it is still as detrimental to health. In addition, the Tester-
185 Hagan Amendment requires the food to be produced and sold in the same state or within 275 miles
186 of the farm or facility. [5] Sans Tester-Hagan amendment, the economic constraint placed on small
187 farms would negatively affect other governmental programs, including the USDA Farm to School
188 Program, WIC Food Program, and the USDA-AMS Farmers Market Promotion Program. [10]

189 2.6. Industry Scale Agriculture and Sustainability

190 Commodity or industry-scale agriculture is typically characterized by a monoculture, a ‘quantity
191 over quality’ mentality, and a linear (as opposed to closed-cycle) relationship between production
192 and the environment. Advancing technology boosted yields of wheat, rice, and maize helped feed
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193 millions of people. This was revolutionary at first, but the economic system in the United States failed
194 to recognize the missing overlap of incentives between nutrition and large-scale production.
195 Infamous words of Earl Butz include “get big or get out” and plant “fence row to fence row”. The
196 U.S. government subsidized corn yields, which urged farmers to grow for the highest yield. This
197 system is currently in place today and has created unforeseen issues. Malnutrition is now an
198 epidemic. As is said by Acharya et al., “1 billion people do not have enough to eat; 2 billion have
199 micronutrient deficiencies; and 1 billion eat too much energy-dense, nutrition-poor food.” It is the job
200 of a food scientist to understand chemical compositions of food and create different products. The
201 abundance of corn has led to our current ‘corn economy’ in which most every processed good
202 contains some aspect of corn. This scientific way of breaking down food and recombining it in
203 different ways has resulted in mass processing of goods. Human instincts have led us to crave a diet
204 of high-fat and high-sugar, and this is what industry and food scientists create. Corn is only one
205 typical ingredient in many processed foods, but it is so abundant due to its cost effectiveness.
206 Chemical compounds derived from corn, including High Fructose Corn Syrups (HFCS) are sweeter
207 than typical sugar (sucrose), thus less product will achieve the same result, and are cheaper than
208 sucrose alternatives. This increase in processing has led us to the obesity epidemic we are currently
209 facing in the United States. Typical large-scale agriculture utilized the assembly line system, which
210 provides a stable local economy. But this stable local economy created by one large conglomeration
211 is unlike that created by multiple small-scale businesses. Many argue the loss of community is a
212 negative impact of the industry scale food system. Environmental degradation is often accompanied
213 by said industry scale agriculture. Soil degradation, toxic chemical use, reliance on fossil fuels for use
214 in planting, harvest, and transportation of product, and loss of biodiversity are all examples of
215 environmental degradation. It is for these reasons that is environmentally more sustainable to
216 produce food on a smaller more local scale. A closed-cycle system of production that utilizes non-
217 synthetic resources, diversity of crops and livestock, and creates a local agriculture community has
218 long been thought to be more sustainable and benefit the environment more so that large scale
219 agriculture.
220 The unsustainability of current arrangements arises from the industrialization
221 and globalization of agriculture and food processing, the shift of consumption
222 patterns toward more dietary animal protein, the emergence of modern food styles
223 that entail heavily processed products, the growing gap on a global scale between
224 rich and poor, and the paradoxical lack of food security amid an abundance of
225 food. [7]

226 2.7. Implications of FSMA on Industrial Agriculture

227 Because of its extensive overhaul of the current system, the FSMA is predicted to alter current
228 industry ideals. For example, the goal of FSMA being to mandate preventative measures against
229 pathogenic contamination, a remedy to this being increased traceability. Increasing traceability can
230 also track environmental hazards and the entire system of preparing a single raw or processed good.
231 This will have positive environmental impacts within the industry, as the FDA will consider soil
232 amendments, temperature controls, animals in the area of production, and naturally occurring
233 hazards.[5] Overall, industry will now be accountable for every aspect of production, and with that
234 knowledge will come the ability to evaluate their sustainability and change their production to better
235 suit the environment. This is speculation and is not to say that FSMA will provide linear incentives
236 to industry agriculture to downsize. In fact, companies already comply to many if not all of the latest
237 regulations. Food safety recalls severely impact branding and food safety, though not strictly
238 regulated, is taken seriously by many companies. Plans were previously in place to prevent and
239 implement a recall, but FSMA simply created a baseline and a commonality amongst all levels of food
240 production and processing.

241 2.8. Traceability and Possible Environmental Impacts

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242 The advancement of technology has allowed for the availability of electronic traceability.
243 Whereas prior to the internet and network sharing the source of a pathogenic outbreak was relatively
244 unknown, now food can be traced back to the very field where it was grown. This is due in part to
245 industry management, whose job it is to ensure safe and quality products. Numbers are tracked on
246 every farm and every facility in an effort to minimize safety hazards. Reasoning behind this system
247 is intuitive. Ground beef has a higher risk of contamination with pathogenic strains of E. coli due to
248 the higher risk of contaminated beef infecting equipment and subsequently infecting all other beef.
249 All beef affected would need to be recalled, and if no source of contamination is known, there is no
250 way to prevent the issue from recurring. This is true for any other contamination scenario as well. It
251 is very important in the food industry to manage sources of input and quality of each input
252 separately. This system was incentivized prior to FSMA due to the economic and social cost of recalls.
253 But through the FSMA, traceability is regulated and mandated. This means that any potato, onion,
254 head of lettuce or other food product will be monitored for quality assurance and traceable back to
255 the field. But traceability doesn’t only apply to safety due to microbiological contaminants. The FDA
256 will also track pesticide, herbicide, and fertilizer usage and time between application and harvest.
257 This is in an effort to prevent toxic chemicals from entering our food system. Toxic chemicals have
258 negative effects on human health, particularly those more susceptible, such as children under age
259 three, elderly, and immunocompromised. Increasing traceability in this sector will allow a more
260 thorough evaluation of when chemicals are not necessary, proper timing of application, and
261 appropriate concentrations. Not only does this protect the health of consumers, but it positively
262 impacts the environment as well. Toxicity in chemicals can affect soil microbes, which have
263 tremendous impact on yields of crops, quality of soil, and overall sustainability. A more appropriate
264 and managed application of synthetic inputs in agriculture would significantly increase populations
265 of healthy soil microbes. This would be beneficial for industry agriculture in the long-term as well,
266 due to higher yields and less need for chemical inputs.

267 3. Conclusions
268 The Food Safety Modernization Act, signed into law in January of 2011, is primarily a
269 preventative action law for control of pathogenic microbes in the food industry. Prevention may
270 sound simple to implement, but because of lax governmental food safety enforcement and regulation
271 prior, FSMA is a massive overhaul of the United States food system. The FSMA mandates prevention
272 policy, corrective action plans, food safety plans, recall procedure, and grants the FDA more
273 oversight power. Non-inclusive policy prior to FSMA includes: Pure Food and Drug Act and the
274 Meat Inspection Act in 1906, Farm Bill of 1990, The Food Security Act of 1985, and HACCP, Hazard
275 Analysis of Critical Control Points. These bills and acts show differing governmental policy, ranging
276 from incentivizing environmental sustainability and small-scale farms to incentivizing and
277 supporting markets of commodity crops to recognizing the scale of industry and creating regulatory
278 policy in response to outbreaks and consumer preference. Small scale agriculture is commonly hailed
279 by environmentalists to be a more sustainable long-term option. Small-scale farms typically use fewer
280 synthetic inputs, utilize diversity of species, create community, and stem from farmers’ passion for
281 the soil, crops, and livestock. FSMA won’t affect many small-scale farms due to the Tester-Hagan
282 Amendment, but this freedom does not exempt them from food safety liability issues. Small-farms
283 may still be required to obtain certain certificates, such as the Good Farming Practices certificate.
284 While small farms have immense environmental and social positive implications, conventional,
285 large-scale, or industrial farms are the most common form of agriculture in the United States today.
286 Industrial agriculture most often utilized synthetic inputs, including fertilizer, pesticides, and
287 herbicides. Industrial agriculture typically includes a monoculture, create environmentally
288 unbalanced emissions, and degrade soil compositions. This system of production is subsidized by
289 the U.S. government and possibly integral to sustaining our growing population. Because industrial
290 agriculture has a broad resource base and is aware of the implications of recalls and pathogenic
291 contamination, FSMA may affect them minimally as effective systems for control and management
292 of microbial contamination are already in place. While it is true that food companies of the industry
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293 scale are aware of impacts of recalls and contamination costs and many will be relatively unaffected
294 by the new regulations, FSMA is revolutionary in its creation of a baseline for all companies to adhere
295 to. While FSMA may not affect large-scale companies, it’s impact would be devastating to small
296 farms. With compliance costs upward of 6% of total small-farm food sales, FSMA would have
297 eliminated the economic feasibility of small farms. But this act nontypically favored small farms and
298 recognized their importance to community culture, environmental sustainability, health, and
299 nutritional value. During the application of new mandates, all affected companies will have little
300 choice than the increase the traceability of their products. This includes tracking all pesticide,
301 herbicide, and fertilizer application. This traceability will help farmers and management track and
302 possibly reduce use of these products. The Food Safety Modernization Act of 2011 was a
303 revolutionary overhaul of the current industrial food system in the United States, yet it allowed
304 smaller-scale agriculture to remain feasible. The act increased traceability and has a focus on tracking
305 chemical use in agriculture, which may lead to a decreased use of such chemicals. Finally, the act
306 serves as a prevention mechanism within the industrial agriculture sector, and will prevent
307 contamination from entering the food system, which will increase the health of consumers and lower
308 the cost of illness.

309 Funding: This research received no external funding.

310 Conflicts of Interest: The author declares no conflicts of interest.

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348 (http://creativecommons.org/licenses/by/4.0/).