At the time it was hailed as the first major overhaul of the US nation’s food safety practices since 1938. As such, FSMA demands serious attention from any organisation concerned with global food standards. The Act is also now reaching a level of maturity, with US businesses setting compliance deadlines for international partners. Accepted procedures and protocols are also rapidly emerging for companies that want to achieve compliance in the safest and most effective ways.
If you haven’t done so already, the time is now to look at what you might need to do to respond.
Step 1: Check if FSMA applies to you
The most significant change that FSMA brings is that it gives the Food and Drug Administration (FDA) new enforcement powers focused on prevention and risk-based food safety standards. It also looks at the food supply chain from end-to-end and covers most types of company that either (a) grow, harvest, pack, or hold produce; or (b) run facilities that process food for human consumption.
From an international perspective, FSMA also provides the FDA with the tools to hold imported foods to the same standards – so it applies to international suppliers and producers of food as much as it does to US businesses. Specifically, FSMA applies to you if you are:
- A US food manufacturer with a domestic supply chain
- Or a foreign food manufacturing site that supplies food to the US
It should also be noted that the FSMA regulations focus on addressing food safety risks from microbial pathogen contamination (e.g. Salmonella, E. coli O157:H7, and Shigella). However, the regulations do not address food safety risks from genetically engineered crops, pesticide use, or antibiotic resistance.
Step 2: Check timelines and what you need to do to respond
Timelines for compliance set out by the FDA are complex and can depend on the size of your organisation. In some cases, they depend on the type of product you produce. Some US food businesses are also now imposing their advanced compliance expectation dates, which you’ll need to comply with if you want to carry on doing business with them.
For the latest information on compliance dates and timeliness, the best thing to do is to reference compliance dates on the FDA website.
Step 3: Get FSMA ready
For those preparing for FSMA compliance, it’s important to ensure you have the right pre-requisite programs and risk-based preventative controls in place. Various guidance documents and audit checklists have been made available for download.
For example, BRC Global Standards offer a free module, the ‘FSMA Preventive Controls Preparedness Module and Guidance for BRC certified Facilities’, which has been designed to identify the key prescriptive elements your facility should have in place to meet the regulatory requirements. It has also been designed to apply to any facility producing products or ingredients destined for the US market.
Once completed, you should then attend a Food Safety Preventive Controls Alliance (FSPCA) training course and use the learnings to review and perform a self-assessment. This will allow you and your organisation to prepare procedures and establish necessary controls for FSMA before you contact your certification body and arrange a FSMA audit. Following this route will enable you to become officially certified as FSMA ready.
If you are following the BRC Standards methodology, you should also call the FSMA certification body and instruct them to add the FSMA Preventive Controls Preparedness Module and Guidance for BRC-certified Facilities on to their next planned audit.