The Food Safety Modernization Act (FSMA) – An Overview
The primary purpose of the American Food Safety Modernization Act (FSMA) is to improve food safety standards by changing both industry’s and government’s approach to food safety from reactive to preventive. This ground breaking piece of food safety legislation is broken down into four main sections:
- Improving capacity to prevent food safety problems through: registration of food facilities; risk-based preventive controls; performance standards; produce safety standards; anaphylaxis and allergy management and many others
- Improving capacity to detect and respond to food safety problems through: allocating inspection resources between domestic and foreign facilities and ports of entry; laboratory accreditation; tracking and tracing foods; mandatory recall authority, etc.
- Improving the safety of imported foods through: a foreign supplier verification program; authority to require import certifications; inspection of foreign facilities; third party auditors; etc.
- Miscellaneous provisions such as: funding for food safety; employee protections; jurisdiction and authorities; compliance with international agreements.
As part of this comprehensive change, the Food and Drug Administration (FDA) has been releasing rules to specifically address important aspects of food safety. These include the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals,the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and the FSMA Final Rule for Preventive Controls for Human Food.Other rules include:
- Preventive Controls for Food for Animals Final Rule
- Accredited Third-Party Certification Final Rule
- Sanitary Transportation of Human and Animal Food Final Rule
- Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule
The changes are dramatic. For example, the regulations address Preventive Controls. The details of this are outlined in the Preventive Controls Rule but, briefly, companies are now required to:
- carry out a hazard/risk assessment
- create a written plan to deal with the identified hazards
- document the implementation of and ongoing testing procedures outlined in this plan
- plan for any corrective measures that may be necessary.
On their side, staff at the FDA is working to establish science-based standards for testing. One area they are specifically focusing on is safe production and harvesting of produce. The Produce Rule is one part of this ongoing process.
The FDA’s Food Safety Modernization Act also gives the FDA the power to hold companies accountable for these preventive controls, primarily through inspection. This represents a huge change in food safety legislation and so the FDA is changing the way its inspection resources
are allocated, utilizing a proactive, risk-based assessment process. The focus is on innovation with the goal of providing effective and efficient services.
Special attention is given to ensuring that imported foods meet the same food safety standards as domestic foods. The Foreign Supplier Verification Rule details the requirements, but beyond stating that importers are required to carry out supplier verification procedures to ensure the imported food is safe, the legislation also:
- gives the FDA the right to refuse admission if the foreign facility or the other country does not allow the FDA to carry out an inspection
- allows the FDA to require certification that the food is safe
- offers an incentive for suppliers to improve their food safety procedures by granting expedited clearance if they provide assurances that allow them to qualify for a voluntary program
Should anything go wrong, the FSMA gives the FDA the right to issue a mandatory recall. Although historically most companies have been very cooperative when asked to implement a voluntary recall, this change is an important step in protecting the public health.
In most cases, the Act gives dates of compliance based on the size of the operation and defines very small and small businesses. Very small businesses are given the longest time to reach compliance, small businesses slightly less time and the rest have the shortest time to comply.
Finally, the legislation also recognizes the need for the FDA to partner with state, local, territorial and tribal authorities to enhance the food safety network. As well, the FDA is mandated to work with all of these authorities to provide food safety training, and it offers grants to help increase the number of labs and certified testing facilities.
Companies are strongly encourage to become “FSMA ready” now to mitigate any risks associated with non-compliance, once the rules are finalized.