Shutdown, Transition to National Processing Program Slowed FDA Import Processing: Sources

The government shutdown has been "weighing heavily on everybody's mind right now. You get something that is perishable ... and then you get an email back saying that we'll look at it once the government reopens. You know, what does that mean for your product?" said Mike Lahar, chairman of the regulatory agencies committee for the National Customs Brokers & Forwarders Association of America. He also serves as regulatory affairs manager for A.N. Deringer.

In response to an inquiry about the delays, a spokesperson for the FDA's Office of Inspections and Investigations said in an automated reply that "certain federal government activities have ceased due to a lack of appropriated funding." This includes responding to press inquiries. ITT also reached out to the main FDA press office for comment.

While the government shutdown could potentially be resolved soon, as reports over this weekend noted that some Democratic senators have voted with Republican senators to support an end to the shutdown, the effects of the shutdown could linger for some time.

"I have not heard of or experienced any significant delays in the past few weeks specifically related to the new FDA structure. [But] the government shutdown could also be delaying import releases so it would be difficult to discern the exact cause" of any delays, said Elisabeth Lomax, a trade compliance consultant whose clients include those that need FDA's approval to clear their imports.

The new FDA structure that Lomax was referring to was a transition that took place in August. In July, the FDA's Office of Import Operations, which is affiliated with the FDA's Office of Inspections and Investigations, said it would make "important" changes to its Nationalized Entry Review Program on Aug. 4 that were meant to "revolutionize import operations" by using a technology-driven approach that will streamline operations (see 2507280041).

This change also involved transitioning from port-by-port reviews to a nationwide system that utilizes staff across multiple time zones to provide for expanded coverage, explores automation opportunities to streamline processes and optimizes resources to focus on higher-risk products, the FDA said in a release.

While the nationwide system might eventually quicken import processing for all goods under the FDA's purview, the agency's ability to process imports slowed as the agency transitioned from the regional program to the national program, according to Lomax. She described how one of her clients had imported goods waiting to be processed by the FDA for weeks in August and September. She had heard that other companies, such as those importing pharmaceuticals, were also experiencing delays in August and September in getting their goods released by the FDA at the ports.

One of the challenges that importers have faced from the transition to the new compliance process is trying to find someone at the FDA to inquire or alert the agency about delays that the imported goods are facing.

"When they did have delays, one of the big issues was, who do we even contact? Because before, they could always contact someone at the port about what was needed and about what the status was, but now it's very difficult to get anybody on the phone," Lomax said. She described a situation where an importer reached out to the port director, but the port director didn't respond because the approval process is now occurring at the national entry review centers.

While her client's imports eventually were released by the FDA, that client and others didn't receive any information on whether they needed to provide more information to the FDA to complete the processing, according to Lomax.

Since those initial transition hiccups in August and September, the delay time frames began shortening -- although the government shutdown, which began on Oct. 1, made it unlikely for the FDA to speed up import processing significantly. Even if import compliance officers weren't furloughed due to the shutdown, the effect of the furloughs may have trickled down, Lahar said.

"Given the overall situation, I really think things are going as well as could be expected. And I think maybe there is a certain amount of deference that we probably want to give the agency, given the current state of affairs," Lahar said. "At the end of the day, we're all trying to achieve the same goal. We're trying to keep trade moving as efficiently as possible while at the same time protecting our families."

Some higher-level reviews slowed during the shutdown, according to Lahar, although the exact cause of that slowdown is unclear. However, imports where the FDA has issued alerts, such as those involving imports from Indonesia (see 2510030022), may be among those that are experiencing processing delays.

"Yes, delays continue, but there really isn’t a pattern," Lahar told ITT last week. "One thing that I did learn is it appears that FDA is targeting products from Indonesia in general ... . It makes sense, really, and you can't criticize them for that … they are doing their job."

Still another possible reason for the delays this fall has been the different hours of operation between the FDA and CBP, according to Lahar. While CBP operates 24/7, the FDA's offices along the southern border don't operate those same hours.

NCBFAA, some regional customs brokers associations and the FDA have been working to get extended hours of service at these ports, Lahar said.

Although it's the delays that get the attention, some commodities, such as produce, actually have seen their processing times quicken after the FDA transitioned to the national processing program, according to Lahar.

Now that the FDA has this formalized program, some underlying problems that the FDA had with the import information it was receiving may have been coming to the surface after the transition, Lahar said.

"So, we've had to work through this period of time where maybe we had to up our game a little bit, and make sure that, for example, if you were transmitting a product code that said you're shipping fresh produce, well, to make sure you put that in the description as well, and that just helps FDA systems process things using AI," Lahar continued. He noted that one of the larger ports told him that the FDA's national program has been processing some imports promptly.

"It's a learning curve for everybody -- the FDA, brokerage community, importers -- making sure we're getting correct information to FDA," Lahar said.

"The best advice I can give brokers and importers is to pay particular attention to the information they're providing or transmitting to make sure that the FDA has what they need to release their shipments," Lahar said. "So, be proactive. Ensure documents are complete and accurate. Expect delays, extra time for FDA-regulated entries, and just in general, keep your eyes and ears open for updates." This includes visiting FDA and CBP websites and NCBFAA's website, which has a page for tracking government shutdown-related information, as well as reading industry publications, he said.