By Charles Breen, Independent Advisor for FSMA
The next FSMA/FSVP compliance date is March 19, 2018. FDA enforcement activities begin with:
- Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods (PCHF);
- Importers of animal food whose Large Business Foreign Supplier is subject to the Preventive Controls (PC) requirements in PCAF, but not to CGMP requirements;
- Importers of animal food whose Small Business Foreign Supplier is subject to PCAF cGMP requirements
Importers are already being inspected for the adequacy of their FSVP. A quick look at the most recent FDA inspection citations with data through January 15, 2018, shows nearly 100 Foreign Supplier Verification Program (FSVP) violations since FDA started inspecting importers last year. The citations made show that in many cases there is a clear lack of understanding, not only of the requirements but the implications for lack of compliance. FDA can stop an importer from importing food for which there is no evidence that the food complies with FDA requirements.
For anyone keeping score, March 19th marks the compliance date for 30th, 31st and 32nd FSMA rules, and the seventh, eighth and ninth for FSVP-specific rules so far.
It is important to also note that even though seafood, juice beverages, infant formula, dietary supplements, and Low Acid Canned Foods (LACF) foods may not be subject to significant parts of the FSMA preventive controls regulation, USDA regulated products are completely exempt, no FDA-regulated food has a complete exemption. When companies are producing foods that combine USDA and FDA regulated foods, whichever agency regulates the final food product may not be the only one regulating some of the ingredients of this final food. These companies need to check to be sure their food safety programs meet the requirements of either USDA, FDA or in a few cases, both. EAS has the expertise and regulatory knowledge to assist companies in navigating these sometimes-murky regulatory waters.
USDA’s various inspection Acts, (poultry products, egg products, the Federal Meat Inspection Act) have jurisdiction over these imported products at the time of U.S. entry. While USDA and FDA requirements are gradually coming into closer alignment, each agency’s requirements are still quite different. Understanding both sets of requirements is warranted for those whom this applies.
So, back to the March 19th deadline and what it means for you. First – does your company even need to comply with FSVP? Is your foreign food supplier aware that in order to comply fully with FSVP, they must first comply with the FSMA Preventive Controls regulations (human food and animal foods as applicable)? FDA has developed a handy flow-chart to help you make that determination. Even so, it’s not always so simple to understand the correct regulatory path to compliance – particularly in the case of seafood, juice beverages, infant formula, dietary supplements, and LACF foods – when and what FSVP rules must be followed, comply with FSVP.
The size of a business is a factor in whether companies need to comply, as is the case with those that meet the definition of a “very small businesses” (i.e., earned less than $1 million per year on average in the preceding three calendar years, adjusted for inflation from 2011, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale; or in the case of Animal Food – $2.5 million per year for three years in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee)). FDA provides a useful tool to help calculate inflation. For example, $1 million in 2011 is adjusted to $1,078,242 in 2016.
There are other exemptions in addition to those mentioned above. Imported food from Canada, New Zealand and Australia are still required to meet FSVP requirements. However, those who import foods from these countries may document FSVP compliance by relying on inspections by officially recognized food safety inspections in those countries. Their food safety systems are deemed to be comparable to that of FDA. Companies must clarify that imported food is within the scope of that official recognition or equivalency determination. For example, baked goods are food by definition, but are regulated by Health Canada. The mutual recognition with Canada is between FDA and CFIA, not HC. The details of this FDA recognition are still being worked out and food companies from Canada, New Zealand and Australia should consult with their US customs agents or EAS for the latest information on this moving target.
The many components of FSMA Preventive Controls regulations and the detailed technical aspects of FSVP alone are challenging to understand and implement. Addressing those challenges from two interwoven US regulations may sometimes require the assistance of outside experts, such as those at EAS, who can help you navigate the requirements and determine a course of action.
EAS offers FSMA services in all areas of food – from Dairy to Juice to Produce, Seafood, LACF, Infant Formula and dietary supplement manufacturers who fall under FSMA and FSVP requirements, workings with manufacturers, processors, holders and packers and transporters of products as well as their retailers.
EAS services in the area of FSMA and FSVP can save time and eliminate confusion. Understanding what rules apply to whom and how to develop compliant procedures can make all the difference when FDA inspectors arrive at your door. Don’t let your company be part of the next FDA inspection citations list or find your company on the FDA Import Alert list. Whether with the help of EAS or working independently with your own internal staff, make sure your FSVP compliance documentation is in good working order.
Posted in EASeNews, Foods, FSMA Perspective and tagged Charles Breen.