Looking back at the audits I completed in 2015, I have encountered several locations that canceled upcoming audits due to issues found during their site inspection. Some lost their GFSI certification due to non-compliances noted during audits. However, the good news is that most locations, regardless of their audit status, demonstrated a dedication to continuous improvement.
You’ve probably heard a lot recently about how all GFSI or non-GFSI certified sites are now faced with a new challenge - to comply with new FDA Food Safety Modernization Act (FSMA) regulations.
The FSMA finalized rules result in three key things that will impact the food industry in 2016. I’ve listed them below and have included a few specifics you will want to keep in mind.
The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final and compliance dates for some businesses begin as early as September 2016. Other compliance dates are staggered over several years. According to the official FDA announcement, the final rule will have an impact as follows:
- Very small businesses - Sites averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale will have three years to comply. Note: Records to support a company’s status as a very small business will be required by January 1, 2016.
- Businesses subject to the Pasteurized Milk Ordinance (PMO) - Compliance dates are extended to allow time for changes to the PMO safety standards. PMO standards must incorporate the requirements of the newly finalized preventive controls rule. These facilities should start preparing now, though they will have up to three years to comply.
- Small businesses - A business with fewer than 500 full-time equivalent employees will have two years to fully implement the preventive controls measures outlined in FSMA’s final rule.
- All other businesses - If your facility does not fall under one of the above categories, you will have only one year to demonstrate compliance with preventive controls requirements.
Foreign Supplier Verification Programs (FSVP)
For importers of food for humans and animals, FSVP requirements are now final and compliance dates for some businesses begin in just 18 months. The final rule requires that importers perform stringent risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
How to prepare:
- Establish a thorough vetting process for foreign suppliers/vendors
- Train employees on what to look for and how to reject questionable supply
- Conduct regular internal audits of food safety programs
- Incorporate FSVP into your food safety plan
- Keep thorough records of your process
The Qualified Individual
In order for the site to comply with the Preventive Controls for Human Food rule, each site, regardless of size, will need to have a ‘qualified individual’ on staff. A qualified individual is defined by the FDA as a person who has the necessary education, training, and experience to perform the activities and internal audits needed to meet the FSVP requirements.
This person must have successfully completed training in the development and application of risk-based preventive controls under a standardized curriculum. The curriculum must be recognized as adequate by FDA. A qualified individual may also be eligible through job experience though the experience necessary may be unclear. It is prudent to put any qualified individual through standardized training to mitigate the risk of non-compliance.
Whether sites produce human food, animal food, import food for humans, or import food for animals, they will need to begin preparing for compliance with FSMA’s finalized rules in 2016. The implementation of required programs in compliance with these rules needs to be conducted by a qualified individual. Several training courses are available to processors that will satisfy the curriculum required by the FDA.