Food and drug regulation

Purpose: To investigate & integrate knowledge of advanced nursing practice, scholarly inquiry, & leadership by examining a policy at the level of clinical practice, health care systems, or public/social health policy. Students are to submit a paper between 5-8 pages long excluding title page and reference pages. Paper must be organized according to the guidelines below and should include all the identified sections as required. Paper must be completed in APA format and contain current scholarly sources dated from 2012 until current. The following may be selected as topics for this paper:

-Food and drug regulation

-Abortion clinic access

-Planned Parenthood funding

-Correctional health

-LGBTQ health

-Tobacco regulation

-Veterans health

-Medicaid

-Medicare

-Prescription drugs

-Managed health care

-Clean Air act

-Clean Water act

-NIH reauthorization

-Head Start

-Healthcare reform

Running head: FOOD AND DRUG REGULATION IN USA 1

FOOD AND DRUG REGULATION IN USA 15

Food and Drug Regulation in the USA

Sample Policy Analysis Paper

University Name

Introduction

Every day across the United States, people purchase foods, groceries, eat out and prepare their families meals. It is expected that all food is safe, and the role of the FDA is to ensure food safety. The FDA has the authorization of ensuring the safety of the immeasurable range of foods eaten by the Americans, which is about 80% of all the foods that are sold in the Country. The food includes everything except the processed egg products, poultry, and meat that are controlled by the Department of Agriculture in the US. The FDA was given the mandate of developing an integrated and comprehensive FDA Food Protection Plan (Thomas, 2014). The plan was to make sure that the safety supply of the nations food from deliberate and unintended contamination. Inspired by the science and the modern technology, the Food Protection Plan aim is to identify the likely hazards and deal with them before they can harm human health. The center of such a progressive effort is the augmented focus on hazard prevention. The Food Protection Plan was developed to create safety measures that address the risks in the entire life cycle of a product, from the time a product is produced to its distribution and consumption. The plan directs the efforts of FDA on the prevention of problems and then applies interventions that are risk-based to make sure that the preventive approaches used are successful (Thomas, 2014). The plan requires a fast response as soon as there is a detection of contaminated food or products or when people or animals are harmed. The policy is a public/social health policy. The purpose analysis of the Food Protection Plan policy is to establish if the plan is effective in accomplishing preventing the problem of food poisoning. The analysis intends to answer the questions of the effectiveness of the policy in the prevention of food poisoning.

Background

Changing demographics and consumption trends

The changing consumption and demographics have raised the susceptibility of consumers to food poisoning. It was approximated that 20% of the American people were 60 years or more (Halabi, 2015). The older people are usually at a higher risk of foodborne diseases. It thus indicates that due to changing demographics the number of susceptible consumers has increased and the factors of convenience mean that small problems can result in great outbreaks. Consequently, there is a need for changes to ensure a high degree of food protection.

Convenience trends

More Americans are now consumers of convenience foods. Foods that are prepared away from home are likely to be cross contaminated from the other foods and contaminated by the food workers (Halabi, 2015). With more Americans eating ready food, it means that vulnerability to foodborne diseases has increased.

The consumption patterns have changed with a large variety of food is eaten all year round. Besides, foods that are eaten raw or with little processing tend to be linked with foodborne diseases. The consumption of fresh fruits in the US has increased by about 36% since 2000 (Halabi, 2015).

Global food supply

The United States imports from over 150 nations. Based on research, about 15% of all the food distributed in the US is from imports. In other food types like fresh vegetables and fruits, a higher proportion is imported (Halabi, 2015). The imported food increases vulnerability to food poisoning due to the transporting conditions and the production conditions that may not meet the standards required by FDA. Whereas most importing countries have well-developed regulatory mechanisms to promote food safety, others have systems that are not well-developed to make sure the imported food is safe.

New threats

Currently, CDC is aware of over 200 foodborne pathogens. These are such as parasites, viruses, bacteria, toxins and potential contaminant of metal and chemicals. The different agents linked to food borne diseases have steadily increased, and it is likely that the list will continue increasing (Thomas, 2014). The emerging of new foodborne pathogens calls for updating of technology to detect their presence in different foods. Consequently, to address the problem of emerging pathogens, there is a need for partnership between the government, industry and research institutions to establish a solution.

Existing policy

The FDA has been responding fast enough to contain problems of food safety. However, while it has maintained that kind of response, it created the plan that was to enhance its response by developing safety into the products right from the production step to encounter the current problem (Thomas, 2014). In the Food Protection Plan policy, it proposes to partner with the private institutions in building on the activities of the food sector to promote food safety.

Strengths

The policy will be useful in ensuring that the Americans continue benefiting from the safety supplies of food in the world. The food protection office will provide advice and guidelines on local and imported foods (Shames et al., 2015). The FPP will promote corporate responsibility to ensure that food problems do not happen in the first place. The FDA by reviewing the vulnerabilities in the food supply and developing and executing measures to reduce risks, it will be addressing critical weaknesses in food safety (Shames et al., 2015). In the intervention elements, the preventive measures are implemented correctly, ensuring that the existing food safety issues are addressed. The FPP will ensure speed and efficiency by responding to an emergency as soon as it is reported. Whether contamination is deliberate or unintended, fast response is important for the protection of the public.

Shortcomings

Although the plan may be viewed as a constructive development, it needs some amendments. Questions have been released since it was released. For example, the Government Accountability Office has pointed weakness on the specifics of the implementation of the Plan. The Food Protection Plan is not clear in its implementation (Shames et al., 2015). The plan lacks details on its efficient targeting of resources in its implementation, budgetary constraints as well as its implementation timeline. Without enough details on the implementation, it is likely that the plan will not be properly implemented.

Stakeholders

Individuals

All people will be affected by the policy especially those who are highly vulnerable to foodborne pathogens like the young children, older adults, and pregnant women. These groups comprise of about 25% of the U.S population. The Food Protection Plan aims at making food safe for all the people through prevention of the likely hazards (Shames et al., 2015).

Food manufacturers

The FDA regulates over 130 registered local food facilities, which includes manufacturers, food processors, food warehouses, restaurants and institutional food establishments. The FDA also oversees the activities of supermarkets and grocery stores.

Importers

All the food importers are regulated by the FDA law ensuring that food imported meets the FDA guidelines.

Other Government and Nongovernment Institutions

The FDA in the implementation of the Food Protection Plan is partnering with the other institutions like the Agriculture departments, State Health departments, Universities. Also, the FDA has to work together with governments of the importing nations to ensure the imports meet the required safety standards in the USA.

Analysis

Alternative policy

In responding to the events related to foodborne illnesses, the United States Congress passed legislation – the Food Safety Modernization Act. The law was meant to move the FDA focus for improved protection of public health by prevention instead of reacting to outbreaks. The FSMA is a large part of the law that was intended to create new practical central food safety system. FSMA changes the role of the FDA from being reactive to being preventive.

In the selection of the best policy between the Food Protection Plan policy and the FSMA, the effectiveness, goals, impacts of each will be measured.

FSMA evaluation

Effectiveness

FSMA increases the safety requirements for the food industry and vests FDA with more power to enforce the requirements. Its wide scope affects almost all the food industry members such as importers, producers, manufacturers, distributors, and transporters. The law also requires the foreign suppliers to observe with the FSMA requirements, as it raises the authority of the FDA abroad (Humphrey, 2016). It is intended that the FSMA implementation will apply scientific and risk-based principles that consider the expertise of the existing food safety of the industry.

The effectiveness of the FSMA can be witnessed by the shift towards prevention, which is in the last rules, where the policy requires that all the food consumed in the USA observe the Hazard Analysis standards and Critical Control Points (Humphrey, 2016). Effectiveness is also in the requirement to farms to take certain measures in ensuring prevention of food safety hazards. The foreign suppliers are required to confirm that they have met the specified preventive requirements before their products being accepted in the US. The FDA has conducted frequent meetings with the stakeholders to educate them on FSMA and seek feedback (Humphrey, 2016). Such efforts of the FDA through the new law have proved to increase effectiveness in enhancing food safety in the country.

Problem solving

After a decade of diseases outbreaks, market disruptions and problems with imports safety that cost billions of dollars on the food system, the FSMA was developed to prevent problems rather than reacting to problems (Humphrey, 2016). In that manner, it is expected that food safety goals will be achieved.

As the FSMA guidance development is continuing, the FDA is still preparing for its implementation. The preparation has been mainly in training, as well as enforcement of issues. In accommodating of the diversity and complexity of the food industry, the FDA has transformed its internal organization to fit the required specialization to effectively implement and enforce the FSMA.

Implications

The new law centers on prevention by the FDA. The FDA was accorded lawmaking authority to ask for complete, science-based preventive regulations in the supplying of food. Under the FSMA, implementation of necessary preventive regulations for food facilities, as well as the compliance with compulsory safety standards for produce will be required (Humphrey, 2016). Moreover, there is a suggested additional regulation that will be establishing least principles for safety in production and the collecting of vegetables and fruits. The rule will also tackle the issue of soil amendments, hygiene, and health of workers.

The food importers will also be required by FSMA to confirm that enough food safety is ensured while importing.

Evaluation of the Food Protection Plan policy

Effectiveness

A policy has to meet the goals that it was intended to meet. The application of scientific findings can have a strong effect on the implementation of policies diverting efforts away from the agenda of the policy (Bardach & Patashnik, 2016). In the Food Protection Plan, the FDA had a goal of improving communication with the stakeholders on the preventive measures in the protection of food supply. The goal has been met since FDA has been undertaking some of the activities to partner with the stakeholders in the implementation of the preventive measures in ensuring food protection. For example, after it was launched in 2007, the FDA held a meeting with 50 states on August 2008 at Missouri. The meeting was attended by more than 200 States, Federal, Tribal, Territorial and local partners to discuss the problems and the opportunities to promote food safety in America.

The Food Protection Plan has met the goal of building-in Food Safety Upfront by identifying and implementing the Best Practices and Standards. The FDA has been partnering with stakeholders and the industry in identifying and ensuring application of best practices to prevent threats to food safety early enough (Halabi, 2015).

The Plan has accomplished another goal of identifying food vulnerability and evaluating the risks. In this, it has increased identification and understanding of food susceptibilities. The FDA has researched in several areas associated with food protection and food safety. The FDA has in meeting this goal and been targeting risk reduction by implementing Risk-Based processes. The FDA has an established Risk-Based Steering Committee that ensures that an organized, comprehensive risk-based measure is taken concerning the protection of food.

Another goal of the plan was to increase the understanding and use of effective mitigation approaches. The goal has been accomplished through expanding the FDA research, development and the assessment of strategies for detection and mitigation.

Problem solving

Policies are designed to solve a problem that is of concern to the nations (Bardach & Patashnik, 2016). Consequently, for a policy to be considered effective, it has to provide a solution to the problem it was intended. One of the problems identified that were to be solved by the policy was the problem of increased vulnerability. The policy has addressed this problem through food protection plan. The policy aimed at focusing inspections and sampling according to the risk. In tackling the problem, FDA has expanded its field capacity for both imported and local foods using risk-based inspection. It has also reduced vulnerability by developing its screening technology at the border which prevents importation of hazardous foods. The plan has ensured increased safety for imported foods through third-party documentation programs. Since imported food increases vulnerability, taking the outlined steps tackles the problem.

Since the consumptions patterns of the people have increased the level of foodborne diseases, there is a need for updated technologies for better and faster testing of foods to understand new hazards and promote food safety. The problem of new and increased foodborne illnesses is solved through improvement of risk-based examination by increased laboratory capability.

Implications

The Food Protection Plan suggests new legislative authorities that strengthen the capacity of the FDA in ensuring food safety. The plan proposes legislations like allowing the FDA ask for control against intended defilement by criminals at high venerability points in the food chain. Legislative is also allowing the FDA to issue more preventive controls for the foods that are considered to be at high risk. The legislative authorities also require the FDA to renew registration after 2 years and authorizing the FDA to change the registration categories.

By the Plan targeting the resources required to ensure optimum reduction of risk through intervention, it centers on the risk-based surveillance (Bacchi & Goodwin, 2016). The plan includes a proposal of legislative authorities for the FDA to accredit the third parties who are highly qualified to inspect food. An accreditation program would ensure that only the safe food is allowed for human consumption. However, the accreditation program would have limitations in that it would take time before an organization is accredited despite it dealing with safe food, it may have to wait for the accreditation.

The plan suggests legislative authorities that strengthen the response ability of the FDA. The first legislative authority is to empower the FDA to require a compulsory recall of the foods when there are no voluntary recalls and when they are not effective. Consequently, the FDA will improve its effectiveness in recalling of food products. With the increase in recalls, it shows how often foods leave the producers or country of origin with a potential of causing health harm. The recalls mean a negative economic impact on the company or country involved (Mason, 2016). The other legislative authority provides the FDA with improved access to foods during emergencies. It thus assists the FDA in improving its response to emergencies. With improved response to emergencies, it means that many lives are saved.

The introduction of the efficient assessment of the greatest risk points along the food chain ensures the strengthening of the ability of the FDA to evaluate, prevent and respond positively to a likely attack along the food chain (Mason, 2016). Consequently, the system can be said to be an insurance that is sought by the company to understand the areas that are prone to risks across the production and manufacturing process and it puts in place ways of improving security and chances of safety threat to the food.
Food protection plan The FSMA
It fails to specify the actions to ensure safety It specifies the validated regulations
Its focus is on control points instead of outcome It is metric-driven with the implications being quantified.
It does not conduct training of the food industry members affected It educates the food industry members affected
It does not focus on a lot of rules to ensure safety but works in partnering with stakeholders like government institutions. It has in place many rules in ensuring safety

Recommendations

Based on the analysis, the best alternative to address the problem of food safety in the US is the FSMA. The FSMA shows a high level of effectiveness as it works with the affected members on ensuring that the regulations can be implemented and the benefits are more than the costs. For example, it offers guidance and assistance to the food industry members for them to know the regulations and they are supported in complying.

Strategies

The central role will be played by the FDA to act as an innovation and action catalyst. The FDA should leverage resources and support from others by partnering to build an integrated world food safety network comprised of federal, states, and foreign governments (United States, 2015). Due to the complexity of the food system in the world, and the demand for high assurance levels that the systems are working, it is important that the FDA include the traditional and the new tools in its implementation of FSMA.

Barriers

The greatest barrier to the implementation of FSMA is a lack of awareness on the new regulation and how they can be applied. Particularly the medium and small sized companies may not be aware of some of the laws that apply to them. The Hazard Analysis and Critical Control Points plan only are not enough to comply with the set rules. Moreover, it is not all companies that have the HACCP (United States, 2015). Another barrier is a lack of resources, as the implementation of FSMA is a major undertaking that requires technical and financial resources.

Evaluation of the implication of the policy

The policy will be evaluated based on the decline in the level of outbreaks. Proper implementation of the policy will enhance food safety which will ensure a decrease in foodborne illnesses. The statistics on foodborne illnesses will be gotten from healthcare and public health ministry. Also, the CDC would provide statistics on the decline on new illnesses as it has been previously.

Discussion

It is established that since the development of the Food Protection Plan, the level of foodborne diseases has continued to increase. That could be an indication of its low effectiveness. Consequently, an alternative FSMA law was established by the Congress addressing the shortcoming of the Food Protection Plan. The analysis of the two policies shows that the FSMA is improved in the sense that it seeks to give more authority to the FDA to play the role of leadership in the implementation of the policy.

The analysis of the Food Protection Plan was limited by the fact that there are limited details concerning the policy, thus limiting secondary data. The analysis is also limited in that there is no field research conducted but the research relies on secondary data, thus limiting the validity of data.

The research is important in determining the outcome of the policies to ensure the right allocation of resources to the most effective one.

Conclusion

The food protection plan was developed to solve the problems associated with foodborne illnesses. The analysis of the policy indicates that the policy meets the goals of the FDA of solving the problem of increased vulnerability to foodborne illnesses. However, the policy has gaps in that it is not specific on the regulations to be applied to ensure food safety. Consequently, an alternative policy that was developed later has shown to be more effective. It is thus important that the FDA would implement the FSMA policy because it has proven effective. FDA should monitor the changing trends in the food industry and make amendments to the policy based on the changes to improve its effectiveness. Awareness on food safety should also be created to improve protection and prevention of food poisoning.

References

Bacchi, C., & Goodwin, S. (2016). Poststructural Policy Analysis: A Guide to Practice. New York Palgrave Macmillan US.

Bardach, E., & Patashnik, E. M. (2016). A practical guide for policy analysis: The eightfold path to more effective problem-solving. Los Angeles: CQ Press/SAGE.

Halabi, S. F. (2015). Food and drug regulation in an era of globalized markets. Amsterdam [u.a.: Elsevier/AP.

Mason, D. J. (2016). Policy & politics in nursing and health care. St. Louis, Missouri: Elsevier, 2016.

Thomas, C. I. P. (2014). In food we trust: The politics of purity in American food regulation. Lincoln: University of Nebraska Press.

Shames, L., United States., & United States. (2015). Federal oversight of food safety: FDA has provided few details on the resources and strategies needed to implement its Food Protection Plan: testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. Washington, D.C.: U.S. Govt. Accountability Office.

Humphrey, J. (2016). Food Safety, Private Standards Schemes and Trade: The Implications of the FDA Food Safety Modernization Act. Ids Working Papers, 2012, 403, 1-65.

United States. (2015). Examining the implementation of the Food Safety Modernization Act: Hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session,

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