The purpose of FSMA is to enable the U.S. FDA to better protect public health matters by reinforcing the food safety system.
Each year in the United States, 48 million people are affected by foodborne illnesses. In fact, on average, 128,000 are hospitalized and 3,000 die. To combat this unceasing issue, The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 by President Obama.
The purpose of FSMA is to enable the U.S. Food and Drug Administration (FDA) to better protect public health matters by reinforcing the food safety program. The law allows for the FDA to develop preventative measures to combat foodborne diseases, rather than the reactive approach taken in the past. The law provides the FDA with the resources needed to achieve satisfactory rates of food safety compliance, while developing a sound response and containment infrastructure.
The following are the foundational elements of FSMA:
There are 3 key mandates under the prevention category, including:
- Mandatory preventive controls for food facilities: The goal is to ensure all food facilities have a written preventive control plan to mitigate potential hazards affecting food safety.
- Mandatory produce safety standards: The FDA must establish a science-based, minimum standard for the harvesting of fresh produce.
- Authority to prevent intentional contamination: Requires the FDA to develop a comprehensive plan to identify and secure vulnerable points of the food supply chain.
Inspection and Compliance
The intention of FSMA is to develop an efficient and preventative control standard to protect public health. However, the law only works if enforced correctly. These tools are designed to ensure compliance:
- Mandated inspection frequency: FSMA requires a mandated inspection frequency of food facilities. Including 5 years within enactment of the law for facilities deemed ‘high-risk’ and no more than 3 years following.
- Record Access: The FDA will have access to all food safety records of facilities.
- Testing by accredited laboratories: The FDA is required to establish a laboratory accreditation program. When established, the laboratories will carry out specific food testing under direction of the agency.
When the inevitable occurs and an outbreak is reported, the following steps will be taken to aid the containment process:
- Mandatory recall: If a company fails to comply with an FDA ordered recall, FSMA grants the FDA power to recall that company’s unsafe products.
- Expanded administrative detention: This term describes the procedure enabling the FDA to prevent suspect foods from being shipped. The new law grants them more flexibility when it comes to this sensitive issue.
- Suspension of registration: If it is determined a specific facility is producing food that poses an imminent threat to the public’s health, FSMA allows for the suspended registration and production of that facility until it is deemed safe.
FSMA gives the FDA unprecedented control of the standards regulating imported goods. Important new authorities include:
- Importer accountability: Importers now have the responsibility of vetting their foreign suppliers’ preventive controls.
- Third Party Certification: The FDA will establish a program that allows for certified third parties to establish whether or not a foreign supplier’s facilities comply with U.S. standards.
- Authority to deny entry: If a supplier or country denies the FDA access to its facilities, the agency has the right to deny entry of those products into the US.
One of the responsibilities of FSMA is to build and maintain an amicable and collaborative system with both foreign and domestic government agencies. These agencies must work together to maximize their resources and communication tools in order to achieve their public health goals. Examples of enhanced collaboration include:
- State and local capacity building: It is the FDA’s responsibility to develop and execute a strategy to enhance food safety and the defense capacities of State and local agencies.
- Foreign capacity building: The above responsibility applies to foreign agencies, too. Additional responsibilities include addressing the training program for these foreign agencies to maximize their knowledge of U.S. food safety policies.
- Reliance on inspections by other agencies: It wouldn’t be plausible for the FDA to conduct every inspection needed for public food safety. Therefore, they rely on other Federal, State, and local agencies to not only conduct, but adhere to their mandates. The FSMA allows for the agency to enter into interagency agreements to leverage all resources needed to ensure the safety of our nation’s food supply.
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