Running head FOOD AND DRUG REGULATION IN USA 1FOOD A.docx

Running head: FOOD AND DRUG REGULATION IN USA
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FOOD AND DRUG REGULATION IN USA
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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 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
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, February 5, 2014.

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