Regulatory Roundup: News out of FDA & CPSC

While Customs and Border Protection (CBP) is the most visible and well-known enforcement presence for imported goods, they work in tandem with multiple regulatory agencies. Those agencies are called “Participating Government Agencies,” or PGA for short. When Sobel transmits information about an arriving shipment on behalf of an importer, we are providing not just the HTS number and value to CBP, and we may also be sending pertinent information to one of those agencies to make their own admissibility determination.

The Food & Drug Administration and CPSC are both in the news, and our clients whose goods fall under their jurisdiction should be aware of the changes and what they mean for their supply chains.

FDA stepping up enforcement on FSVP’s

The Foreign Supplier Verification Program is one of the components of the FDA’s multilayered strategy to track the chain of custody of food products from origin to destination. Companies are required to register on the agency’s website and regularly update and recertify their information.

An increasing number of failures has prompted the agency to step up enforcement for participants in the FSVP program, both through remote and on-site inspections as well as warning letters to importers for violations. Many of the violations surround maintaining appropriate documentation or having plans as required by the agency.

Ongoing failure to comply with FSVP regulations could put an importer on an Import Alert. Where other Import Alerts can be removed with five non-violative shipments, companies put on an IA for FSVP violations will remain there until they have demonstrated compliance with the requirements.

As an example, FDA recently posted a warning letter to an importer in New York for repeated violations of the regulation that can be viewed here.

Sobel Network Shipping is capable of helping importers both ensure compliance with the FSVP regulations and provide referrals to companies to create and maintain the required documentation.

CPSC joins ACE 1 USG messaging

The Consumer Product Safety Commission in March began communicating electronically with customs brokers filing entries on the release status of products under their jurisdiction.

Customs brokers send information to Customs and PGA for release through the Automated Commercial Environment (ACE). Over time, the agencies have migrated from an all-paper process to a semi-electronic process, and many are now receiving and viewing the entire electronic data submission and making admissibility determinations on the same message set as Customs.

One of the last agencies – and from a public safety perspective, one of the most important – to fully be onboarded in the messaging was the Consumer Product Safety Commission (CPSC).

For the most part, the go-live has been smooth, but we wanted to let importers whose merchandise requires their approval a window into the process.

  • Sobel transmits the entry data that includes HTS, quantity, value, and manufacturer information. That HTS number has a flag which triggers the eligibility and notification of CPSC.
  • Initially, the shipment is considered “Under Review,” but the agency then begins their process of determining admissibility.
  • Provided the data is presented to the agency three or more days prior to arrival, CPSC says that goods should receive a May Proceed within five minutes. For shipments three days or less, anywhere from 8 to 16 hours depending upon arrival time and the importer’s compliance history.
  • The May Proceed action will then allow for the triggering of the “1USG” message, which means that a shipment has been released by CBP and all governing PGA’s.

The Under Review message will not stop the product in transit to the final named destination (i.e., if it is filed while the goods are on the water in transit to either a final destination port of arrival or inland port via rail). If the agency wishes to look at the cargo, they may request an Intensive Examination, or CBP or another agency has requested an examination. They will inspect the merchandise as well.

Our online tracking system provides multiple status messages that are delivered directly by the relevant government agencies. At any time, importers can query their shipments for the most recent release status from CBP and any of the PGA’s involved in a transaction.

For more information, please contact your Sobel Network Shipping representative.