Feed the Future
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Food Safety Modernization Act, an Example of Modern Food Safety Public Regulation

Serious food safety threats continue to be a widespread concern in both developed and developing countries; contaminated food respects no national boundaries. Billions of people are at risk of unsafe food, millions become sick and hundreds of thousands die every year. Even in the United States, which has one of the strongest food safety systems in the world, there is are frequent outbreaks. According to the US Centers for Disease Control and Prevention (CDC), 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths result from foodborne diseases in the United States every year.

Consumers rely on their governments to ensure that food is safe. Ensuring safe and high quality food for consumers is a concrete indicator of high quality governance. Whatever limited resources a government has, risk-based food safety policies must be in place to ensure that food is safe and wholesome for its citizens. In our globalized world, food safety is a complex international policy issue, situated at the intersection of agricultural, health and trade policies. These policies should contribute to achieving an effective food safety system throughout entire food supply chains including production, harvest, processing, storage, transportation, trade, retail and preparation (restaurants, private homes, etc.). National and international food safety legislations are developed in response to particular policy needs.

Recently, countries such as United States, United Kingdom and Canada have begun to modernize their food safety regulations. In the United States, the food supply chain is regulated at the federal and state levels. The federal government has the broad power to protect the general public and to regulate food safety for interstate commerce. State governments have the responsibility and power to ensure food safety within their boundaries. However, states have always adopted food safety regulations consistent with the federal food safety laws and regulations. The major federal organizations responsible for food safety in the United States are the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA)-Food Safety and Inspection Service (FSIS). The FDA regulates more than 80 percent of the nation’s food, while the USDA-FSIS regulates meat, poultry and processed eggs. In the United States, developing and implementing food safety regulations and systems such as Hazard Analysis and Critical Control Point (HACCP) may have played a significant role in reducing the number of foodborne illnesses, hospitalizations and deaths, which have fallen by almost 40 percent over the past 20 years. However, the United States food safety system is not perfect, as the numbers of illnesses, hospitalizations and deaths (as stated above) are still high. Therefore, it was necessary for the FDA to undertake comprehensive reforms in its approach to food safety through the Food Safety Modernization Act (FSMA; more than 50 regulations and guidelines).

FSMA is an amazing example of a modernized public food safety regulation, led by the FDA. FSMA was signed into law in 2011 to better protect public health by ensuring the safety of the US food supply. FSMA is the first major legislative reform of FDA's food safety authorities since 1938 and is shifting the focus of the FDA from reacting to contamination to preventing contamination. FSMA recognizes that food safety is a responsibility shared among the US federal, state, academia, food industry/private sectors, consumers and foreign food safety agencies. However, FSMA also recognizes that the food industry has the primary responsibility to produce safe food. FSMA mandates food safety standards, enhances traceability systems and empowers third-party certification and private sector verification inspection of foreign food facilities. FSMA allows FDA to use risk-based prioritization to target most serious foodborne health hazards and food facilities in both domestic and foreign countries. FSMA gives the FDA authority to increase the frequency of inspection of high-risk food facilities (domestic and foreign), conduct mandatory recalls of tainted food products, enhance FDA’s traceability capacity, detain unsafe food and suspend a facility's registration.

FSMA contains seven foundational rules:

  1. Produce Safety Standards rule sets standards for the growing, harvesting, packing and holding of fruits and vegetables on farms, both domestic and foreign. Final rule published: November 27, 2015. Effective date: January 26, 2016. Compliance date: January 26, 2018 - January 26, 2020.
  2. Preventive Controls for Human Food rule focuses on developing food safety plans to prevent hazards that cause human foodborne illness. Final rule published: September 17, 2015. Effective date: November 16, 2015. Compliance date: September 19, 2016 - September 17, 2018.
  3. Preventive Controls for Animal Feed rule focuses on developing current good manufacturing practices and preventive controls to prevent hazards that cause animal diseases. Final rule published: September 17, 2015. Effective date: November 16, 2015. Compliance date: September 19, 2016 - September 17, 2019.
  4. Foreign Supplier Verification Program rule requires importers to be accountable for the safety of imported food. Final rule published: November 27, 2015. Effective date: January 26, 2016. Compliance date: May 27, 2017.
  5. Accredited Third Party Certification rule allows qualified third-party auditors to conduct food safety audits and provide certifications to foreign facilities (produce food for humans or animals) who comply with FSMA. Final rule published: November 27, 2015. Effective date: January 26, 2016. Compliance date: NA
  6. Mitigation Strategies to Protect Food from Intentional Adulteration rule requires domestic and international facilities to address vulnerable processes to prevent acts intended to cause public harm. Final rule published: May 27, 2016. Effective date: July 26, 2016. Compliance date: July 26, 2019 - July 26, 2021.
  7. Sanitary Transportation of Human and Animal Food rule prevents practices in transport that create food safety risks. Final rule published: April 6, 2016. Effective date: June 6, 2016. Compliance date: April 6, 2017 - April 6, 2018.   

As you can see from the compliance dates above, implementation of FSMA takes phases over a few years to provide flexibility to farms and food businesses, especially small and very small businesses, to comply with FSMA requirements. For example, the compliance dates for the Preventive Control for Human Food rule (finalized in 2015), are three, two and one years, for the very small, small and large firms, respectively. A few developing countries (such as China, United Arab Emirates, Egypt, etc.) are also in the process of modernizing their food safety regulations. More developing countries should follow suit to modernize their food safety regulations/standards which can be done with the help of developed countries.


This is a really great overview of FSMA Barakat. Thanks!

You're welcome. Thanks, Lee!