In September of 2016, large producers and shippers of both human and animal food were required to come into compliance with the FSMA (click here for the fundamentals of FSMA). These new, preventative standards were designed and passed in order to proactively reduce the number of foodborne illness incidents versus reacting to events. Now, by September of 2017, small businesses with less than 500 full-time employees will need to comply.
With larger companies now dealing with FSMA regulations, let’s take a look at what has happened since the compliance date. We all know that change can be difficult, right? Well, the FDA certainly found out how true that statement can be, and they have now issued a few clarifications and additional guidelines.
What Requirements Apply?
As you know, the industry already has a host of regulations and certifications in place. Businesses are wondering if GFSI certification covers their FSMA compliance. Processors likely have a Hazard Analysis and Critical Control Point (HACCP) program in place, so how do they pivot to more proactive Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan? Do they need a HARPC plan?
One resource to check your status comes from SGS, a global inspection, verification and certification company. They have a questionnaire that you can use to clarify what rules apply to your operation.
Once you determine what’s needed, a bit of advice. Don’t throw out your HACCP or other food safety plans. Starting from scratch is not necessary as the FSMA builds on the same principles. You’ll likely see some gaps that need to be filled, but education, training and using tools such as trailer tracking with remote, real-time temperature monitoring can quickly bring you into compliance.
New Q&A from the FDA
Shortly after the first phase of compliance rolled out in September, the FDA saw a lot of questions and confusion. In response, they issued a new guidance document in November called, “Questions and Answers Regarding Food Facility Registration (Seventh Edition).”
In this draft, the FDA added and answered new questions and revised information that was provided in earlier drafts. They also aimed for greater clarity to help businesses in their efforts to comply.
Questions this new document covers include:
- Who Must Register?
- Who Is Exempt from Registration?
- Definitions (Facility, Food, Holding, etc.)
- When Must You Register or Renew Your Registration?
- How and Where Do You Register or Renew Your Registration?
- What Information Is Required in the Registration?
- What Optional Items Are Included in the Registration?
- How and When Do You Update Your Facility’s Registration Information?
- How and When Do You Cancel Your Facility’s Registration Information?
- What Other Registration Requirements Apply?
- What Are the Consequences of Failing to Register, Renew, Update, or Cancel Your Registration?
- What Does Assignment of a Registration Number Mean?
- Is Food Registration Information Available to the Public?
- Waiver Request
- General Registration Questions
- Suspension of Registration
- Compliance Dates
Updates to the FDA’s Voluntary Qualified Importer Program
In November of last year, the FDA also provided updated rules regarding their fee-based program that allows proven facilities to expedite the review and importation of foods. These companies must already have high-level supply chain safety and security that’s been certified and maintained over time. With this program, the FDA hopes to be able to focus more resources on higher-risk suppliers and carriers.
While the full text can be found here, the basic criteria importers must meet to be eligible to participate in the FDA’s Voluntary Qualified Importer Program (VQIP) include:
- Must have a developed and implemented Quality Assurance Program (QAP)
- Must show compliance with supplier verification and other importer responsibilities
- Must hold current facility certification issued under FDA’s Accredited Third-Party Certification regulations for each foreign supplier
- Must have a 3-year minimum history of importing food to the United States
- Must not have ongoing FDA administrative or judicial action or other non-compliance issues
- Must have a Dun & Bradstreet Data Universal Numbering System (DUNS)
Are You a Carrier in Compliance with the FSMA?
With the FSMA in effect for large businesses and just around the corner for smaller companies, it’s vital to work with a carrier or manage a trucking company that can meet regulations for food transportation. This includes proper refrigeration, vehicle sanitation and documentation.
At Spireon, we developed the FleetLocate FL14 device to help you out. Here’s what it can help you do:
- Stay compliant with FSMA temperature rules
- Save resources with a value-priced solution and one-way communication
- Provide temperature reports for your customers and in case of audit
- Pinpoint the location of any refrigerated trailer whether it’s moving or parked
Want to learn more? Read up on the 4 key components of FSMA and what FleetLocate FL14 can do for you. Or if you’d rather talk live, get in touch with us: call (800) 557.1449 or schedule a free demo today.
While we strive to provide you with periodic updates regarding the FSMA, we highly recommend that you keep an eye on the FDA’s website for the latest news.