Association of Food Industries

2020s: A New Decade Where Education Meets Enforcement 

Paul K. Jeka
All-Ways Forwarding International

AFI has led the way in advising its members and others in the U.S. food import industry to prepare for FSMA, FSVP compliance, FSVP importer audits, VQIP participation, C-TPAT and Importer Security Filing. There’s no doubt that enforcement is now upon us. For example, if you have not already applied for C-TPAT certification – you can’t. C-TPAT is suspending applications from Jan. 1, 2020 - June 1, 2020, while it updates the eligibility requirements and the security profile with new minimum security criteria. 

Many in the industry are scrambling to get up to speed with these regulations. If you have vendors or customers that are asking “why are we suddenly subject to these regulations?”, you may want to advise them to attend the next AFI FSVP training program. FDA has made it clear it’s moving away from the “Educate While We Regulate” approach to enforcement. 

BE PREPARED: FDA IS COMING TO VISIT YOU

FDA announced it will conduct 1,400 FSVP inspections for FY 2020. Having participated in the FSVP audit process many times, the experience can vary widely, depending on the FDA officer assigned to conduct your audit and, of course, your company’s preparation. One of the first questions you’ll hear is “are you familiar with FSVP and have you received any FSVP training?”

Some audits have been in conducted in a very friendly (educational) environment and take about two hours. The agency provides the FDA official with a guideline that includes the below listed 7 principles and the official simply checks off that you are compliant if presented with accurate supporting documents immediately when requested. Alternatively, during a recent FSVP audit, the auditing official seemed ill-prepared and downright hostile and spent more than eight hours reviewing what we believed to be sufficient documentation. Even after presenting everything requested, the importer was written up for three violations. Of course, the importer had the opportunity to address the violations and defend itself after the official was literally shown the door!

The seven principles are:

  • Principle 1 - Conduct a Hazard Analysis. ...this can be found on FDA’s website…it helps you identify what each of your products should be tested for. The FDA Link for Hazard Analysis can be found here: https://www.fda.gov/media/99581/download
  • Principle 2 - Identify the Critical Control Points.
  • Principle 3 - Establish Critical Limits.
  • Principle 4- Monitor CCP.
  • Principle 5 - Establish Corrective Action ... in the event of a positive lab result.
  • Principle 6 - Verification.
  • Principle 7 - Record keeping.

Importers are required to have documentation that demonstrates each product from each of its foreign suppliers addresses all seven principles.

FDA also likes to see a complete listing of all your imported items available in one excel file, though you’ll be required to show the inspector the information below for only the entry or entries subject to the inspection. Below is a list of the minimum scope of information that’s expected to be included within these files. The key here is redundancy. Please note this very important detail: EVERY DOCUMENT PRESENTED TO FDA MUST BE SIGNED AND DATED! 

  • Importer of Record IRS# & DUNS #
  • Item #/SKU
  • Exact product description as listed on the retail or wholesale import label (manufacturing process flow charts, ingredient statements and copies of the labels should be readily available)
  • Supporting documentation for label claims such as Non-GMO, Gluten-Free, Organic, Allergens, Kosher etc.
  • Actual manufacturer full name and address
  • Manufacturer MID # and DUNS #
  • Manufacturer/facility FDA Registration #
  • U.S. agent for each item that you import.
  • FSVP Importer (All FSVP Importer required documentation should available by SKU)
  • HACCP reports for each SKU you import
  • USHTS # & duty rates (with supporting documentation to prove it)
  • USDA permits, OGA certificates, licenses and forms that may be required

Be prepared. If it hasn’t happened already, FDA is coming to visit you. AFI offers the Food Safety Preventive Controls Alliance FSVP training program. In fact, AFI President Bob Bauer was on the task force, that along with FDA officials and others, developed the program. Whether it’s through AFI or another entity, you’ll be well-served to have at least two employees take the course. Why two? What if you only send one and that person leaves the company or is away for business or personal reasons when FDA comes knocking?

TRADE DISPUTES

As tensions between the U.S. and China ease somewhat, The EU Airbus dispute takes center stage. Thankfully, another dispute involving the French digital services tax appears to be on hold for the remainder of 2020.

Many in the industry – on both sides of the Atlantic – are already feeling the effects from the Airbus Annex 1. As this was being written, possible changes via a second annex were possible within weeks. The Annex 1 additional duties have been applied and the impact on U.S. importers has been harsh.  To say the least, importers are feeling the pinch and looking, where possible, at alternative solutions to satisfy consumer needs. 

Exporters from EU Member States should be putting pressure on their governments to address this issue. U.S. importers can’t absorb a 25-percent increase in costs. Some are buying less. Others are looking for other sources. Still others can’t stay in business if the dispute drags on. Once a customer is lost and/or finds another source of supply, it could be quite a challenge to regain that business. 

Tough times!  Let’s see what the market will bear and what the future will bring.

Association of Food Industries: Serving the U.S. Food Import Trade Since 1906
3301 Route 66, Ste. 205, Bldg. C • Neptune, NJ 07753
(732) 922-3008 • Fax: (732) 922-3590 • afius.org • info@afius.org