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Center for Food Safety v Hamburg: Detailed Analysis

Abstract

Previously, the United States witnessed a series of outbreaks of foodborne illness, resulting in several deaths. Investigations revealed that the food industry is more concerned with the profits at the expense of providing quality products and services. Therefore, there was a need to enact the relevant laws that would guide the operations of the food industry. This led to the development of the Food Safety and Modernization Act (FSMA). The implementation of the Act resulted in a lawsuit dubbed Center for Food v Hamburg. The issue presented in this case was whether the FDA unreasonably delaying or unlawfully withholding actions in violation of the APA. The court ruled in favor of the plaintiff and awarded arbitrary deadlines that were equally strict concerned with the implementation of FSMA. Despite the benefits of the FSMA, the strict deadlines attached to this legislation by the court and the congress may eventually cripple the operations of FDA, leading to high costs of food prices. Considering the scope and the magnitude of what they need to address, the court ought to have given the FDA more time to address the issues presented by the legislation.

Introduction/Background

Between the years 2006 to 2010, the United States witnessed a series of outbreaks of foodborne illness, resulting in several deaths (Sun, 2012). It later established that the food industry is more concerned with the profits at the expense of providing quality services. Therefore the congress saw the need to protect the consumers by enacting the Food Safety and Modernization Act (FSMA).

The Center for Food v Hamburg is a lawsuit that resulted from the implementation of the FSMA. The issue began when the congress enacted the Food Safety and Modernization Act (FSMA) of 2010 to regulate the operations in the food industry. The Act was then signed into law in 2011 and it provided the Food and Drug Administration (FDA) with the greater mandate to analyze and address the food safety issues and where possible, prevent them. The FDA was to coordinate its activities with the federal, state, and other food safety agencies (Pitts, 2013). The FDA, through the direction of the congress, decided to promulgate the new regulations in seven areas within one and half years.

One of the areas that were to be addressed relates to the establishment of science-based minimum requirements for conducting a hazard analysis, documentation, and control (Roland, 2014). The legislation required the food industries to establish scientifically written methods of detecting and preventing possible foodborne contaminations (Grossman, 2014). They were to develop scientifically sound methods of monitoring and preventing possible hazards within their food outlets. On the same note, they were required to maintain records of their food handling procedures for a period not less than three years. To achieve this, the FSMA mandated the FDA to target higher risk food facilities during their inspection. On the other hand, the inspection of the foreign facilities was not based on the risk, but based on the quota total facilities that the FDA needs to inspect.

Despite its wide scope, this legislation also provided some exceptions to local and international firms that are considered low risks. The firms that engage in direct farm marketing and more than 50% of their produce are sold to consumers within few miles away were also given exception (Grossman, 2014).

Analysis of the Issue

In some cases, the legislation passed by the senate has strict deadlines for the implementation of such law. However, the body concerned with the implementation may meet some challenges in meeting the strict deadlines. In this case, the body concerned with the implementation of the FSMA seemed unable to meet the strict deadlines set by the lawmakers. Therefore, the plaintiff thought that the agency was unreasonably delaying the implementation of the laws that would guide the operations of the food industry. Therefore, the plaintiff went to court to interpret the legislation and compel the agency to meet the deadlines set by the senate.

In their defense, the FDA was of the opinion that the deadlines stipulated in the Act were self-executing and that the court lacked the jurisdiction to review the action of the agency.  On the same note, the FDA responded that the deadlines described by the Act were not achievable due to their limited staff and the numerous rules in the same subject area. Eventually, the court ruled in favor of the plaintiff by arguing that FSMA and APA rules were violated.

In its initial ruling, the court gave the parties to the case the responsibility of negotiating and deciding the deadlines for the implementation of the legislation. However, these parties seemed too much on the opposite sides that they could not agree on the most flexible date for the implementation of the legislation. The agency felt overwhelmed with lots of things they need to handle and few human resources at their disposal. Therefore, they preferred more time to be able to implement the legislation in a proper manner. On the other hand, the plaintiff thought that is was unreasonable to take too much time to implement such important laws. Therefore, they believed that the deadlines set by the senate are reasonable and appropriate for the implementation of all the sections of the legislation.

In the above ruling, the court reasoned that their powers to compel APA were precedential as previous courts have compelled the agencies that violate the statutory deadlines. The judges saw it fit to issue an injunction to support the quick implementation of this important legislation from the senate. The court argued that the dates set by the congress were significant in effectuating the purpose of the congress. The court was of the view that the congress had intended the rules to be closed ended as reflected within the set time frames. Therefore, the judges weighed the conflicting interest and issued a date that they considered appropriate for the implementation of the FSMA legislation. However, the APA was not impressed by the deadlines and they even made an attempt to appeal. However, their appeal was rejected and they had to act within the law to implement the FSMA regulations within the arbitrary deadlines.

Alternative Points of Views (Pros and cons)

One of the potential benefits of the Center for Food v Hamburg ruling is that it will enable the customers to achieve value for their money. Before the enactment of this legislation, the businesses seemed more focused on making profits at the expense of offering quality products and services. These businesses were taking advantage of the lack of legislation to guide their operations within the food industry (Fagotto, 2014). Therefore, the legislation will benefit the customers by legally forcing the companies in the food sector to enhance their quality standards. Eventually, there will be limited or no cases of outbreaks of foodborne illness.

Despite its perceived benefits, the ruling in Center for Food v Hamburg is likely to make the consumers pay for higher prices for the food products. Already, the FDA is overburdened by the unreasonable deadlines imposed by the courts. This would lead to lots of frustration, leading to divergent of some resources to help meet the strict deadlines. Therefore, the resources that would eventually be used in issuing certificates and permits for the manufacturers are easily taken away to meet the strict deadlines. In return, only a few players will be issued with the certificates and necessary permits, leading to a surge in food prices. The FDA already has a backlog of applications and petitions that need to be addressed (Estes, 2014). The resources that are diverted to cater for the requirement of the strict deadlines would be spent sorting the backlog of applications. Such a state of affairs may also necessitate the development of more petitions and the application backlog, leading the skewed management of food industries (Pitts, 2013). On the same note, the augmentation of the application backlog of applications and more petitions could lead to more certification fees for the food industry. Already, the FDA argued before the courts that they do not have the proper funding to cater for their operations. Therefore, they may feel the need to pass the necessary pressure to the business, who in turn will pass the cost to the consumers. In their deliberation of the FSMA Act, the congress seemed not to care about the possible cost implications that would be passed to the consumers. On the same note, the agency may also raise the fee for their services to help them raise internal funds to help them sort their heavy work burden (Meijer, Tilkin-Franssens, & Van, 2015).

The other impact of this legislation is that businesses have to act in speed to meet the requirements and the deadlines set by the regulation. The faster compliance will come at a cost, since such businesses will have to spend more resources to adhere to the FSMA regulations. Some businesses will have to change their operational strategies for their operations to remain viable. These strategies will have a huge financial impact on the businesses. The FDA estimated that fast compliance with the regulations will cost the each business an average of $30,000. The larger firms would even incur more costs than the smaller first. Conventional economics states that businesses usually pass the high costs of doing business to their consumers (Roland, 2014).

The small businesses are more likely to be affected than the larger businesses concerning the ruling in Center for Food v Hamburg. The current legislation provides a large amount of discretion to FDA without giving them adequate time to define what is meant by small businesses. Due to the exemptions given to the small businesses, some large businesses may also maneuver their operations to meet the classification of small businesses (Estes, 2014). This may result into unnecessary maneuvering from the players in the food industry. On the other hand, the small businesses are likely to be harmed since they will have to look for extra resources to get certification. Also, they will have less time to adhere to the full requirements stipulated in FSMA. More than 50% of the people in the United States consume food from small businesses. When such businesses are affected, the large number of consumers who depend on such businesses will be equally affected.

On the other hand, the case in Center for Food v Hamburg tends to follow the recently adopted issue of unreasonably delay case law. This has resulted in the erosion of the traditional administrative law where the judicial powers of the courts were limited to such issues. Therefore, it sets a unique precedent concerning the administration of state agencies.

Own Point of View

My own take is that the operators in the food industry need to be regulated to offer quality products and services to the consumers. Therefore, the FSMA legislation is good as it will guide the conduct of the players within the food industry. However, my worry stems from the strict deadlines set by the court. Since the food industry is not used to such comprehensive legislation, more time is necessary to analyze the possible outcomes of the legislation. Some companies may be forced to retrench some of their workers and increase the cost of their products due to high costs of operations. Eventually, it is the final consumers who will bear the heavy burden that will result from the legislation due to increased costs of the food products. Of the seven major sections of the FSMA legislation, the court should have given priority to the section of legislation that addresses the highest risk area of the food chain to be implemented fast in that order. This would give the FDA enough time to implement the legislation in a manner that does not adversely interfere with their daily operations. In the scenario that the court had to stick to the strict deadlines, then it should have used its judicial mandate to enforce the relevant arms of the government to increase the funding of the FDA so that they do not get overwhelmed by activities. By enabling the FDA to get increased funding, they agency would hire enough staff to deal with various sections of their expanded mandate without accumulating the unnecessary backlog of applications. This would cushion the customers from the potential high costs of foods due to changes in the food industry.

Conclusion

In conclusion, the food is a very sensitive commodity and the consumers need to be protected from the overzealous businesses that are only keen on making profits. The FSMA is a good piece of legislation with potential benefits to the consumers. However, the strict deadlines attached to this legislation by the congress and the court may eventually cripple the operations of FDA and pass the high costs of consumers. I recommend that the courts ought to have given flexible deadlines for the FDA to discharge its mandate so that the businesses do not pass the high cost of the food business to the consumers. Considering the scope and the magnitude of what they need to address, it is prudent to give FDA flexible deadlines. The ruling also sets a tricky precedent since it erodes the traditional administrative law where the judicial powers were limited in deciding the time frames for the implementation of the pieces of legislation for the agencies.

References

Estes, B. (2014). Prosecuting over peanuts: How the PCA scandal can inform more effective federal criminal enforcement of food safety laws. The Review of Litigation, 33(1), 145-182.

Fagotto, E. (2014). Private roles in food safety provision: The law and economics of private food safety. European Journal of Law and Economics, 37(1), 83-109. doi:http://dx.doi.org/10.1007/s10657-013-9414-z

Grossman, M. R. (2014). USA: Recent FDA regulatory measures. European Food and Feed Law Review : EFFL, 9(1), 60-62.

Meijer, N., Tilkin-Franssens, N., & Van, D. M. (2015). Eleven decades of US American federal food law: How the FDA acquired its statutory powers. European Food and Feed Law Review : EFFL, 10(6), 433-441. 

Pitts, P. J. (2013). Should the HHS decision to overrule FDA on plan B be reversed. Journal of Commercial Biotechnology, 19(2) doi:http://dx.doi.org/10.5912/jcb600

Roland, J. (2014). The Hang-Up with Hamburg: How Center for Food Safety v. Hamburg will Alter the Food Industry. Journal of Business & Technology Law. 9 (2), 357-378

Sun, J. (2012). The evolving appreciation of food safety. European Food and Feed Law Review : EFFL, 7(2), 84-90.

 

 

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