Policy Analysis Paper Guidelines
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
Students are to submit a paper between 8-10 pages long excluding title page and reference pages.
Paper must be completed in APA format and contain current scholarly sources dated from 2012 until
current. In order to avoid plagiarism citations are required in each sentence that is not the students idea.
Paper must be organized according to the guidelines below and should include all the identied sections
as required. A sample paper is attached as guide for this assignment.
The following may be selected as topics for this paper:
-Abortion clinic access
-Planned Parenthood funding
-Managed health care
-Clean Air act
-Clean Water act
A Sample Paper has been attached students to view an example of how this written assignment should
be completed and organized.
Running head: FOOD AND DRUG REGULATION IN USA 1
FOOD AND DRUG REGULATION IN USA 17
Food and Drug Regulation in the USA
Sample Policy Analysis Paper
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 eort 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
eorts 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 eective in accomplishing preventing the problem of food poisoning. The
analysis intends to answer the questions of the eectiveness of the policy in the prevention of food
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.
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
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.
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 dierent 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
dierent 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.
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.
The policy will be useful in ensuring that the Americans continue beneting from the safety supplies of
food in the world. The food protection oce 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 rst 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
eciency 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.
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 Oce has pointed
weakness on the specics 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 ecient 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.
All people will be aected 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).
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.
All the food importers are regulated by the FDA law ensuring that food imported meets the FDA
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
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
eectiveness, goals, impacts of each will be measured.
FSMA increases the safety requirements for the food industry and vests FDA with more power to enforce
the requirements. Its wide scope aects 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 scientic and risk-based principles that consider the
expertise of the existing food safety of the industry.
The eectiveness 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). Eectiveness is also in the requirement to farms to take
certain measures in ensuring prevention of food safety hazards. The foreign suppliers are required to
conrm that they have met the specied 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 eorts of the FDA through the new law have proved to increase
eectiveness in enhancing food safety in the country.
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 t the
required specialization to eectively implement and enforce the FSMA.
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 conrm that enough food safety is ensured while
Evaluation of the Food Protection Plan policy
A policy has to meet the goals that it was intended to meet. The application of scientic ndings can have
a strong eect on the implementation of policies diverting eorts 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 identication 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 eective mitigation approaches.
The goal has been accomplished through expanding the FDA research, development and the assessment
of strategies for detection and mitigation.
Policies are designed to solve a problem that is of concern to the nations (Bardach & Patashnik, 2016).
Consequently, for a policy to be considered eective, it has to provide a solution to the problem it was
intended. One of the problems identied 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 eld 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
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.
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
delement 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
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 qualied 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 rst
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 eective. Consequently, the FDA will improve its eectiveness 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 ecient 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 species the validated regulations
Its focus is on control points instead of outcome It is metric-driven with the implications being quantied.
It does not conduct training of the food industry members aected It educates the food industry
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
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 eectiveness as it works with the aected members on ensuring that the
regulations can be implemented and the benets are more than the costs. For example, it oers guidance
and assistance to the food industry members for them to know the regulations and they are supported in
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
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 nancial 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.
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 eectiveness. 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 eld 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 eective one.
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 specic on the
regulations to be applied to ensure food safety. Consequently, an alternative policy that was developed
later has shown to be more eective. It is thus important that the FDA would implement the FSMA policy
because it has proven eective. FDA should monitor the changing trends in the food industry and make
amendments to the policy based on the changes to improve its eectiveness. Awareness on food safety
should also be created to improve protection and prevention of food poisoning.
Bacchi, C., & Goodwin, S. (2016). Poststructural Policy Analysis: A Guide to Practice. New York Palgrave
Bardach, E., & Patashnik, E. M. (2016). A practical guide for policy analysis: The eightfold path to more
eective problem-solving. Los Angeles: CQ Press/SAGE.
Halabi, S. F. (2015). Food and drug regulation in an era of globalized markets. Amsterdam [u.a.:
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 Oce.