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Join Us For A Complimentary Webinar – Thursday, October 25, 2018 – 12:00 – 1:00 PM ET

Two years into the Trump Administration and:

  • The Consumer Product Safety Commission now has a Republican majority,
  • the Department of Transportation has released its 3.0 guidance on autonomous vehicles,
  • NIST has published a 375-page recommendation on medical device security,
  • the FTC is holding a series of hearings on the transformative nature of the digital transformation on markets.

What does all this activity in the United States mean for companies following the rapidly evolving regulations globally related to the safety and security of products?

This webinar will describe the current landscape at the federal agencies setting policy for product safety and security. With all the recent talk of regulatory humility in the face of great technological change, we’ll discuss whether regulators practice what they preach and if recent actions encourage or stifle innovation. Our session will compare and contrast activities across the federal government relevant to consumer products broadly defined with a particular focus on product safety and security.

Presenters:

Cheryl Falvey, Partner, Crowell & Moring, Washington, DC
John Fuson, Partner, Crowell & Moring, Washington, DC
Peter Miller, Senior Counsel, Crowell & Moring, Washington, DC

 

Please click here to register for this webinar.

 

On July 16, 2018, the Court of Federal Claims released a far-reaching decision in Acetris Health, LLC v. United States, concluding that a drug could qualify as a “U.S.-made end product” under the Trade Agreements clause, FAR 52.225-5, despite a Customs and Border Protection (CBP) ruling under the Trade Agreements Act (TAA), that the drug had not been “substantially transformed” in the United States, the usual test for whether a product from a designated country is eligible for sale to the United States under the TAA. The court concluded that a drug which met the definition of a “domestic end product” would also qualify as a “U.S.-made end product” and enjoined the Department of Veterans Affairs from relying on the CPB ruling in declaring the product ineligible. In doing so, the court has given effect to often overlooked language in the FAR 25.003 definition of “U.S.-made end product” that allows either an item manufactured in the United States or an item substantially transformed in the United States to be eligible for sale to the federal government. The decision opens the door for manufactured COTS items to be eligible under the TAA as long as final assembly occurs in the United States, without regard to the source of a COTS product’s components. It might even have broader implications because the FAR has never included an express definition of “manufacture,” and the definition of “U.S. made end product” does not expressly reference the definition of “domestic end product,” under which, in the Buy American context, “manufacture” is just one of two elements for determining eligibility.

On June 20, 2018, the U.S. Trade Representative (USTR) announced in the Federal Register that, beginning on July 6, 2018, an additional 25% duty will be imposed on products from China set out in Annex A of the notice. The USTR also released details on the public hearing and comments schedule regarding additional proposed tariffs on the list of products set out in Annex C of the notice.

Yesterday’s notice confirmed the USTR’s proposed Section 301 actions on two lists of tariff lines released through a press conference on June 15. The first list included 818 tariff lines valued at $34 billion worth of imports from China. The second list includes 284 tariff lines and is valued at $16 billion worth of imports from China. For details, please click here.

The USTR will convene a public hearing regarding the second list of tariff lines on July 24, 2018. Interested parties are required to file a request to appear at the hearing and a summary of expected testimony by June 28, 2018.

Written comments pertinent to the second list of tariff lines are due by July 23, 2018. Rebuttals to those comments are due by July 31, 2018.

The USTR determined it would establish a process by which U.S. stakeholders could request that particular products classified within a covered tariff subheading in Annex A be excluded from these additional duties. However, details on the exclusion process have not yet been released. The notice indicates that USTR will publish a separate notice describing the product exclusion process, including the procedures for submitting exclusion requests, and an opportunity for interested persons to submit oppositions to a request.

 

 

 

 

 

 

The 11th biennial ministerial conference of the World Trade Organization in Buenos Aires, Argentina failed to deliver any concrete results. As EU Trade Commissioner Cecilia Malmström bluntly stated, “[W]e failed to achieve all our objectives, and did not achieve any multilateral outcome.”

The main areas of contention were agriculture and fisheries, involving the failure to agree on modalities to protect developing countries’ ability to ensure their populations’ food security through public purchase and stockpiling of foodstuffs and the failure to agree to ban subsidies for illegal, unreported, and unregulated fishing, respectively.

Please click here for more information on the conference.