Key Points of FSMA

Detention

The FDA has been given the authority to issue a food recall directly, without the requirement for hard evidence of contamination. The agency is now empowered to seize food that it has any reason to believe is contaminated, adulterated, or misbranded. This change was designed to focus the FDA on prevention, moving away from its current reactive role. If the FDA issues a food recall, it also has power to suspend any food facility’s production should the agency decide that there is an associated health risk. Suspended facilities cannot distribute food, and the FDA may impose suspension or recall fees on the company.

Previously, food manufacturers were only required to register once; however, with the implementation of the new bill, facilities must renew registration between October and December of each even-numbered year.

Cooperation

The law has other agencies working on preparation for outbreaks. Health and Human Services and the Department of Homeland Security have been mandated to prepare specific response and recovery outlines to follow in the event of a foodborne illness outbreak. Additionally, grocery stores will be responsible for keeping customers abreast of all the latest recalls.

Prevention

The FDA will be required to identify the most significant food threats and publish new outlines for food production handlers every two years. Each food production facility will be required to implement a written preventive control plan. The company’s written plan will be required to include all prevention controls such as controls at critical control points, along with verification, monitoring, corrective action, and recordkeeping methodologies. This hazard analysis requirement will ensure that food is not contaminated and will further ensure that food is not misbranded for allergen control. Additionally, the law gives the FDA the power to set nationwide standards for produce production and harvesting.

Tools and Technology

New technologies and tools applicable to preventive regulations include screening for bacteria, improving packaging, and monitoring and maintaining the cold chain. One new method that rapidly screens for bacteria has come from bacterial enzyme research, which has led to the discovery of specific enzymes associated with many different microorganisms. This discovery has made possible the development of proprietary substrates that can identify and link to specific enzymes given off by specific bacteria. Tests such as DeltaTRAK’s FlashCheck Bacterial Enzyme Detection have been developed to utilize these proprietary substrates to produce a fluorescence that can either be read using a fluorometer or by adding a reagent to produce a colormetric reaction. These new tests can confirm the presence or absence of bacteria within a work shift with significant accuracy. The tests are inexpensive, fast, and easy to use, allowing users to monitor and test for contamination more frequently.

Imported Foods

To ensure the safety of foods imported from other countries, FSMA includes stricter requirements, more importer accountability, third-party certification, and new qualified importer programs. To support this focus, the FDA needs to increase field staff and establish new offices in foreign countries. The new act requires U.S. importers to verify that all foreign suppliers have the proper controls in place to ensure they are adhering to food safety requirements. Foods deemed high risk can be refused if the necessary certifications are not recorded. The importers will be required to do this by developing and implementing a Foreign Supplier Verification Program. This verification program is stipulated to include such monitoring and tracking initiatives as records lot certifications, record keeping, hazard controls, sampling, and testing products. Importers are further required to keep records regarding their programs for a period of two years. The bill, which states that the FDA will be given money to increase its staff in the field, requires the department to open offices in at least five international countries that export to the United States.

Inspections

The FDA will be required to increase inspection frequencies from about once every 10 years to once every three years for high-risk facilities and once every seven years for low-risk facilities.