"As the end of 2012 approaches, more and more companies from Spanish and Portuguese-speaking countries are contacting us regarding registering with the FDA," said Edgar Asebey, executive director of the consultancy, FDA Solutions Group.
“Most clients outside of the United States feel as if they haven’t been properly informed,” Anne Marie Gaitan, managing director of the consultancy, told FoodNavigator-USA. “They’re confused as the re-registration requirement because they are accustomed to having their current registration number. They are calling and saying, ‘But I already have a registration number.’”
Registration failures could interrupt supply chain
Even though the re-registration process is a small issue by itself, it could cause some big problems if companies fail to comply, Gaitan said.
“In November, Amy Barringer from FDA gave a webinar in which she specifically reiterated that entries from facilities whose registrations have not been renewed may be detained at the border,” she said.
If a container is held on the docks over lack of a new registration, it could sit there for a while, Gaitan said.
“If the facility registration number has been suspended, they would have to go through the FDA process to appeal the suspension,” she said. FDA guarantees a hearing on a suspension appeal in a timely fashion, Gaitan said, but it still would take some time. And importers would also have to interact with the US Customs Department as to when a container is eligible for inspection.
“All that means time and money,” she said.
FDA, for its part, has acknowledged the the window for registrations to be submitted was narrowed because the agency was not ready to accept registrations at the beginning of October as originally stipulated. So, while the deadline remains Dec. 31, the official position now is that the agency will exercise "enforcement discretion" for re-registrations filed in the month of January.
Make sure supplies are protected
Gaitan said it is imperative for US companies that are bringing in raw materials or finished goods from overseas (likely the lions share these days) to make sure that their overseas partners are in compliance with the re-registration requirement.
“You want to make sure 1. that they have timely renewed and 2. that they have appointed the proper US agent,” she said.
“The other issue with FSMA is that FDA will send notice of inspection to the US agent and to the facility. The FDA has the power to interpret a lack of response to a notice of suspension as a refusal. Lack of response means if you don’t respond within 24 hours to the notice of suspension you have basically denied the inspection. If those facilities are not responsive or the US agent is not facilitating information to the foreign facility, the registration can again be suspended.”
FDA Solutions Group formed in October as a branch of Sandler, Travis & Rosenberg, PA, a customs, international trade and business law firm that has been a leader in helping clients comply with FDA requirements for 35 years. The consultancy is structured on a fee-for-service basis.
US Agents liable for fees
Along with registration services, FDA Solutions Group also acts as U.S. Agent for its clients, the company said. This is new territory under FSMA, Asebey said.
"Before the new law, it wasn't unusual for customs brokers and freight forwarders to act as US Agents," he said. "But that is definitely changing. Where before there was little if any risk involved in becoming a designated US Agent, the FSMA imposes new burdens and potential liabilities on entities serving in that capacity for foreign food facilities. That has made many who have historically accepted agent status rethink whether they want to continue offering that service," he said.
Under FSMA Section 107, the FDA can begin charging a $289 per hour fee for foreign facility re-inspections, according the company. Fees could reach several thousand dollars for a single facility, and the U.S. Agent would be responsible for making sure those fees are paid, he said.