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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 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. A Sample Paper has been attached for students to view an example of how this written assignment should be completed and organized. Paper must be completed in APA format and contain minimum 4 current scholarly sources dated from 2014 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
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Running head: FOOD AND DRUG REGULATION IN USA
Food and Drug Regulation in the USA
Sample Policy Analysis Paper
University Name
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FOOD AND DRUG REGULATION IN USA
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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 nation’s 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
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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
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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
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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).
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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.
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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
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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
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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.
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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
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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
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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
It is metric-driven with the implications being
outcome
quantified.
It does not conduct training of the food
It educates the food industry members affected
industry members affected
It does not focus on a lot of rules to ensure
It has in place many rules in ensuring safety
safety but works in partnering with
stakeholders like government institutions.
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
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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
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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
f …
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