It’s been 5 years since you’ve first started hearing about looming FSMA deadlines. Now that the first deadline for 2016 has arrived, its time for you to understand how this will impact your business.

If your business is simply a retail or restaurant establishment, you initially may feel untouched by this legislation.  This assumption, however, may be very untrue.  Although FSMA is geared to food growers, manufacturers and distributors, businesses in other sectors that are not legally required to comply will still be impacted.  A supplier of ingredients to retail and restaurant business is fully impacted and so as a result, this will inevitably have an impact on all business not directly captured by the law.

It’s quite obvious that one of the main intentions of the new law is to give legislators at FDA more power to regulate and enforce.  The ultimate goal is to shift food industries from a reaction mode to a prevention mode. This shift will initially appear to be very costly and labor intensive, but the reduction in food safety incidents leading to recalls will outweigh all initial costs.

The first FSMA deadlines related to compliance to Preventative Controls for Human and Animal Feed are outlined below:

September 2016: Companies with more than 500 full-time employees

September 2017: Companies with fewer than 500 employees

September 2018: Companies with less than $1 million in average annual sales

Under FSMA each site will be required to have a “Preventative Control Qualified Individual” (PCQI).  A PCQI is required to have successfully completed training in the development and application of risk –based preventative controls.  This individual is responsible for:

• Performing or overseeing the preparation of the food plan
• Validating the preventative controls
• Reviewing records for implementation and effectiveness of preventative controls
• Appropriateness of corrective actions
• Managing the required reanalysis of a food safety plant every three years or whenever changes occur

Being FSMA ready will mean moving from HACCP to HARPC as reviewed in previous articles.  While HACCP involves Critical Control Points (CCPs), HARPC involves controls that are not CCPs.

Supply chain control is essential and is obvious from the Foreign Supplier Verification Program.  This program has compliance deadlines in 2017, but has a huge impact on ingredients and foods coming into the U.S. from outside the country.

In order to import food from foreign suppliers, importers need to ensure they have:

1. Determined known or reasonably foreseeable hazards with each food they are handling
2. Evaluated the risk posed of the food they are importing based on the hazard analysis, and the foreign supplier’s performance
3. Used the risk evaluation connected to the food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
4. Conducted supplier verification activities
5. Conducted corrective actions

Since importers are responsible for their own food safety plans, they are expected to reevaluate these plans every three years. This involves conducting a Hazard Analysis and Risk-Based Preventive Controls, or HARPC assessment on each item of food being imported, and verifying each supplier being used. Importers are also responsible for keeping detailed records of all data and analyses.

Under the Third Party Certification rule, FDA will be choosing accreditation bodies to implement the certification of qualified organizations who will confirm that the requirements of FSMA are being met.

This rule establishes a voluntary program for the accreditation of third party certification bodies, also known as auditors, to conduct food safety audit and issue certification of foreign facilities and the food for humans and animals they produce.  These certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP) which offers expedited review and entry of food.  To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require in specific circumstances that a food offered for import is accompanied by a certification from an accredited third party certification body.

This article has not dealt with every aspect of the FSMA requirements, but it will hopefully give you an understanding of the areas in your business that need to change in order to come into compliance with the new expectations.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries. We evaluate, implement, and provide all the necessary support for your products and operations to gain market access and build confidence in your brand.