Friday the 13th of August will spell real disaster for the nation's food importers if they aren't complying with U.S. Food & Drug Administration (FDA) Bioterrorism Act Regulations by that date, particularly those rules dealing with prior notification. That's the day the FDA (www.fda.gov) will start issuing fines and penalties to food shippers who fail to provide advanced notice of shipments.
It's not that there hasn't been ample notice given of consequences for non-compliance; rolling out in stages, enforcement entered Phase III on June 4. On Aug. 13, however, the FDA will shift full-time into “no more Mr. Nice Guy” mode.
“During Phase II, we've been in an educational mode,” points out John Ferguson, vice president, sales & marketing with PBB Global Logistics (www.pbb.com), a third-party logistics provider (3PL) with special insight into enforcement by FDA and the U.S. Bureau of Customs and Border Protection (www.cbp.gov). “We are seeing a lot of shippers who aren't really performing prior notice functions, because the penalties haven't started.” That has begun to change.
Regulatory directives suggest in Phase III that Customs begin refusing and issuing civil monetary penalties for violations of requirements. Violations are seen in three separate categories. Type A violations deal with inadequate prior notice, i.e., no prior notice, inaccurate prior notice and untimely prior notice. Type B violations deal with unregistered foreign facilities. Type C violations are those for which there is no prior notice confirmation.
The key word used in suggested enforcement for Phase IV is “Refusal.” If minor or inadvertent problems exist with prior notice after Phase IV begins, then education may continue. Otherwise, for all violations, shipments will be refused.
In anticipation of the new bioterrorism regulations regarding food and in order to enhance its North American transportation services, last fall PBB acquired Carrier Connection International, a company with specialized knowledge and equipment for the movement of perishable foods.
PBB saw a need to combine its expertise in FDA regulations and ability to handle customs with Carrier Connection's experience in the food industry. The 3PL now is able to handle temperature-control goods while assuring the shippers that the Customs regulations are being met to prevent delays at the border, Ferguson says.
Indeed, planning in food delivery has become more important than ever, Ferguson adds. If the shipper has a major grocery retail customer, such as Kroger or Wal-Mart, there are scheduled appointments to be met. That reality requires extra-consciousness of possible border delays, and as of next month, an awareness that ignorance of the laws will no longer be accepted as an excuse. LT