Food safety modernization act

The final regulated rule of the FDA is known as the Food Safety Modernization Act (FSMA). This new regulatory framework, which came into effect in September 2016, requires all operators in the food industry (both in the USA and internationally) that produce, handle, or store products intended for the US market to adopt a food safety management system in line with the new regulations on preventive food controls.

The FDA has finalized seven key regulations to implement the FSMA, recognizing that ensuring the safety of food products is a shared responsibility throughout the global supply chain, both for human and animal consumption. The FSMA regulatory package is designed to make the specific actions that need to be taken at each point to prevent contamination clear.

Specifically, the regulations stipulate that domestic and foreign food facilities required to register under section 415 of the Food, Drug, & Cosmetic Act must adhere to the risk-based preventive controls requirements imposed by the FDA Food Safety Modernization Act (FSMA) and the new Current Good Manufacturing Practices (CGMP). It is important to note that the applicability of CGMP does not depend on whether a facility is required to register.

This rule, which became final in September 2015, requires food facilities to have a food safety plan that includes a hazard analysis and risk-based preventive controls to minimize or prevent identified hazards.

The effective dates are staggered based on the size of the company, with staggered dates.

Who is subject to the FSMA regulations?

This set of rules is the result of an extensive awareness campaign directed by the FDA towards the food industry and consumer associations, as the competent authority and regulatory body. Therefore, companies that fall outside the jurisdiction of the FDA, for example, because they are under the control of the USDA, are not subject to FSMA regulations.

The companies that fall under the jurisdiction are therefore subject to official training and the development of a Food Safety Plan and all other documents that make up the Food Safety System. These will be verified not only by the FDA but also by the Importer, who must comply with the Foreign Suppliers Verification Program (FSVP) Regulation.

What is an FSVP?

It is a program that covered importers must implement to verify that their foreign suppliers are producing food in a way that provides the same level of public health protection as preventive controls or product safety regulations, if necessary. It also ensures that the supplier’s food is not adulterated and is properly labeled in compliance with allergen labeling.

Importers are responsible for actions that include (and are explained below):

  • Determination of known and reasonably foreseeable hazards with each food;
  • Risk assessment associated with a food, based on hazard analysis and the foreign supplier’s performance;
  • Use of the risk assessment associated with an imported food and supplier performance to approve suppliers and determine appropriate supplier verification activities;
  • Conducting supplier verification activities;
  • Taking corrective actions.
  • Importers must establish and follow written procedures to ensure that they import foods only from approved foreign suppliers based on an assessment of the risk associated with the imported food and the foreign supplier’s performance, or if necessary, temporarily from unapproved suppliers whose foods are subject to adequate verification activities before being imported.
  • Importers are required to develop, maintain, and follow an FSVP for each food brought into the United States and the foreign supplier of those foods. If the importer obtains a particular food from multiple suppliers, a separate FSVP would be required for each of those suppliers
  • Certain importers that are also manufacturers are required to comply with most FSVP requirements if they:/li>

– Comply with the program requirements dedicated to management under preventive control rules;
– Apply preventive controls for food hazards under the requirements in the preventive control rules; or
– Are not required to apply preventive controls under these regulations in certain circumstances. Examples of such circumstances include situations where the type of food (e.g., coffee beans) cannot be consumed without applying preventive control, or if the customer will significantly reduce or prevent hazards and will comply with requirements for disclosures and written assurances.

  • The risk assessment posed by the imported food and the performance of the foreign supplier must be reassessed at least every three years or if new information about a potential hazard or the foreign supplier’s performance comes to light.

  • Importers are not required to assess the food and the supplier or conduct verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety under applicable requirements. Importers must also disclose accompanying documents stating that the food is not processed to control the identified hazard.

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