Importers must also now make sure all such efforts are documented and resolve all red flags adequately. The records must be maintained for at least two years from date of last revision or replacement, and sometimes longer.
There are also specific provisions for dietary supplements and their components; for very small importers or very small foreign supplier importations (defined as $500,000 in annual worldwide food sales); and imports from foreign suppliers in countries were FDA has recognized the food safety system.
Given the huge responsibility now being put on small- and medium-sized companies to insure the safety of their imported food, it is obvious the risk of doing business has just gone up considerably, along with the cost. Even if the supplier is in a county where FDA approves the food safety system, and even if the local government provides the inspectors, it is reasonable to expect there will be a cost for the resulting report and that cost is likely whether the inspector is from the government or is a third-party auditor. Third-party auditors are the subject of a separate proposal.
What this means to smaller companies is representatives can no longer simply go to a trade show and rely on what they are being told by a potential seller. They can also no longer place an order electronically and wait for its delivery. Even if the importer is satisfied the supplier controls the risk and is the party which must manage it, compliance with the FSMA mandates the importer visit the processing facility or receive a report from an auditor in order to have taken all reasonable steps. Obviously, the size of a given order may influence the amount of due diligence an importer exercises, but in the end, if FDA finds a problem with the shipment, you need to be prepared with the proper documentation and maybe private lab testing to get your shipment released. Having done too little or nothing to vet the supplier can also lead to class action lawsuits and more headaches. Given the costly burden put on small- and medium-sized companies by these new proposals, make sure you file your comments with FDA by the November 26, 2013 deadline.
An additional area of concern is the potential for phony documentation. The audit process is not transparent, so unless the auditors and/or FDA create a way for importers to validate these reports, one has to ask: How can companies, especially small- and medium-sized ones, really protect themselves from the unscrupulous supplier who misrepresents the condition of his supply chain with phony audit reports? At the very least, FDA should provide a means for an importer to report the parties and food product and have the agency provide a simple yes or no to these two questions: Was the company audited and, if so, did it pass (was it found compliant)? FDA may resist out of concern of disclosing trade secrets, but it can simply require that any party submitting an audit report agree certain details may be released publicly, or put another way, trade secrets are waived as to those specific data elements.
Ross is an attorney for the International Trade Counsel at Mitchell Silberberg + Knupp LLP. She can be reached at 310-312-3206.
Leave a Reply