The Food and Drug Administration’s Center for Devices and Radiological Health still has some requirements for radiation-emitting halogen and incandescent lamps and bulbs, even though these products are not subject to an FDA performance standard, the National Customs Brokers & Forwarders Association of America said in an emailed update sent April 23. Currently, only mercury vapor and metal halide lamps with an outer glass envelope are covered by a performance standard due to the risk of radiation if the glass envelope is broken, the NCBFAA said. But even though they are not covered, radiation-emitting halogen and incandescent lamps must still comply with FDA regulations on reporting accidental radiation, notification of defects and repurchases, repairs or replacement, the trade group said. However, “CDRH would be ok if these lamps are disclaimed during import entry since the technology surrounding these products is an old and proven technology,” the NCBFAA said.
The Food and Drug Administration’s Center for Devices and Radiological Health still has some requirements for radiation-emitting halogen and incandescent lamps and bulbs, even though these products are not subject to an FDA performance standard, the National Customs Brokers & Forwarders Association of America said in an emailed update sent April 23. Currently, only mercury vapor and metal halide lamps with an outer glass envelope are covered by a performance standard due to the risk of radiation if the glass envelope is broken, the NCBFAA said. But even though they are not covered, radiation-emitting halogen and incandescent lamps must still comply with FDA regulations on reporting accidental radiation, notification of defects and repurchases, repairs or replacement, the trade group said. However, “CDRH would be ok if these lamps are disclaimed during import entry since the technology surrounding these products is an old and proven technology,” the NCBFAA said.
CBP issued the following releases on commercial trade and related matters:
The European Union and Mexico will further reduce tariffs on each other's goods as part of a new trade agreement, the EU said in a news release. "After several months of intense negotiations, this afternoon we reached an agreement in principle on trade and investment between the European Union and Mexico, as part of the modernisation of our bilateral legal framework," EU and Mexican officials said an April 21 joint statement. "Simpler customs procedures will further benefit the EU's industry, including in sectors like pharmaceuticals, machinery and transport equipment," the EU said.
The European Union and Mexico will further reduce tariffs on each other's goods as part of a new trade agreement, the EU said in a news release. "After several months of intense negotiations, this afternoon we reached an agreement in principle on trade and investment between the European Union and Mexico, as part of the modernisation of our bilateral legal framework," EU and Mexican officials said in a joint statement April 21. "Simpler customs procedures will further benefit the EU's industry, including in sectors like pharmaceuticals, machinery and transport equipment," the EU said. Some technical details are still needed and negotiators hope to have a final text by the end of the year.
A Canadian online pharmacy will pay nearly $35 million, and its owner will serve six months of house arrest and five years of probation, as part of a plea deal to charges that it smuggled misbranded and unapproved drugs and distributed counterfeit medication. CanadaDrugs.com and a web of affiliated companies pleaded guilty in December to undervaluing its entries to evade scrutiny as it distributed foreign drugs to doctors in the United States. A Montana federal judge sentenced the companies and Canada Drugs’ CEO, Kristjan Thorkelson, on April 13.
CBP is seeking comments by June 18 on an existing information collection related to the entry/immediate delivery applications and ACE cargo release, it said in a notice. CBP proposes to extend the expiration date of this information collection with minor changes to the information collected related to safeguard duties on washing machines and solar cells and Section 232 tariffs on steel and aluminum products, as well as an increase of the estimated burden hours associated with the collection.
The Fish and Wildlife Service will soon announce a “limited” ACE production pilot for filing of its partner government agency dataset, the National Customs Brokers & Forwarders Association of America said in an emailed update. The production phase pilot, expected to begin May 1, follows the resumption of testing in the certification environment for FWS entries (see 1701190011), after FWS suspended its initial pilot in January 2017 over concerns the agency had set excessive data requirements (see 1708250042). Importers and brokers have expressed interest in the new pilot, but “very few software developers have been willing to design to the interim plan, only to have to redesign when the final plan is reached,” the NCBFAA said. “The FWS' upcoming pilot will focus initially on low volume importers at low volume ports. Any brokers who are interested in participating in the pilot should contact Tamesha Woulard (tamesha_woulard@fws.gov) to see if they could be a good fit for the initial roll out,” the trade group said. FWS did not comment.
INLT, a new customs broker and “logistics tech start-up,” on April 10 announced “final U.S. government approval and launch of its cloud-based web application,” it said in a press release. The brokerage’s cloud-based software will save “importers and freight forwarders time and money” by connecting importers to their forwarders for classification of goods, submission of documents, tracking and transmission to CBP, the press release said. “INLT is freight agnostic, allowing importers to continue with their current partners while deriving operational, compliance, and cost benefits of INLT’s application,” the company said. INLT’s software will also allow forwarders to “connect their agents globally via INLT’s first of its kind cloud-based application reducing the need for calls, emails, and faxes in a heavily paper-driven industry,” it said.
CBP will expand its definition of "importer" under Importer Security Filing (ISF) regulations, the agency said in a notice. Despite some concerns raised by the National Customs Brokers & Forwarders Association of America and the World Shipping Council (see 1609120024), the final rule adopts the definition changes as proposed in 2016 (see 1607050028). The rule will take effect on May 14.