10 Points of Interest in Complying With the New FSMA Rules

The Food Safety Modernization Act (FSMA) “final rule”, with respect to Foreign Supplier Verification Programs (FSVP), is a means of the US Food and Drug Administration to regulate the human and animal food imports of international importers.

The purpose is to verify that foods are produced in a manner that meets US safety standards—standards that will now be higher as well as more transparent. The key requirements of the FSMA are divided into five sections: scope, hazard analysis, evaluation of food risk and supplier performance, supplier verification, and corrective action. Each requirement has a variable number of guidelines and standards.

Here are 10 things to know to about complying with the new food safety regulations that have recently gone into effect this past month:

1. Hazard analysis and risk-based preventive controls (HARPC)

The FSMA now requires companies to supply the FDA with documentation regarding preventative controls and hazard analysis within 24 hours of an audit. The records produced must also supply preventative controls and hazard analysis data/information from two years prior.

2. Retailer liability

Not only are food companies and distributors responsible for meeting safety standards, retailers can also be held liable for a suppliers’ non-compliance with safety standards. Retailers cannot plead ignorance when a supplier fails to meet the FDA’s standards.

3. Senior management accountability

In the past, the FDA rarely held executives responsible for a company’s failure to meet safety standards. Instead, the management team directly responsible for an infraction was held accountable. The company as a whole might have been fined or experienced a hit to their credentials, but senior management was rarely held personally liable. That is no longer the case. Senior management executives can be held both civilly and criminally responsible for safety standards compliance infractions.

4. Preventative control plans

Importers must write, report, and follow procedures that ensure the food provided by a supplier meets FDA standards. In addition to developing a preventative control plan, importers must document the measures taken to follow the plan and be able to produce the documentation upon request.

Specifically, preventative control plans must do the following:

  • Analyze and outline both known and foreseeable hazards for every food item
  • Use the hazard analysis to evaluate the foreign supplier’s performance
  • Use the analysis of hazards and the evaluation of foreign suppliers’ performance to select foreign suppliers
  • Conduct supplier verification activities
  • Perform corrective actions

5. Details of hazard analysis

There are three types of hazards companies must consider when doing a hazard analysis: biological, chemical, and physical hazards.

  • Biological hazards include vermin, parasites, bacteria, fungus, and viruses
  • Chemical hazards include foods that contain excessive amounts of radiation; herbicides and pesticides; foods with dangerous levels of natural toxicity; chemicals created from the decomposition of food; food additives that do not meet safety standards; and allergens
  • Physical hazards include things like glass, nails, and wood.

6. Specifics of food risk evaluation and supplier performance

The first thing an importer must do in a food risk evaluation is evaluate the hazard analysis. The second objective of the evaluation is determining what entity will be most responsible for minimizing or preventing hazards–the supplier or importer, for example. The evaluation must also determine which FDA food safety regulations apply to a particular import. Furthermore, the evaluation must include a supplier’s corporate profile and safety history. And finally, the evaluation must include a plan for transporting and storing the imported product.

7. Supplier verification

FSMA compliance requires importers vet suppliers by conducting on-site audits annually to determine the likelihood of exposure to a hazard. For importers that are unable to verify a supplier’s adherence to safety standards, the importer can verify compliance with documentation if the information supplied shows the supplier is meeting US FDA Safety Standards.

8. Corrective actions

If non-compliance to FDA standards occurs, the importer must show proof that it has taken corrective actions. This may include using different suppliers or showing documented proof that the supplier in question has corrected its errant practices.

9. Exemptions and modified standards

There are importers who are exempt from the new FSMA Compliance Rules. Many such companies deal in the dietary supplement industry and fall under pre-existing dietary supplement Current Good Manufacturing Practices (CGMP) regulation.

As the FSMA Compliance Rules are established for small importers and importers from certain small suppliers, those with sales greater than $1 million for human foods and $2.5 million for animal foods have different FSVP requirements.

10. Compliance dates

Being mindful of these FSMA Compliance Rules is imperative for moving forward successfully, legally, and safely.

The FSMA Compliance Rules are now in effect as of September 2016.

The Product Expiration Blind Spot