Recent Trade & Tariff Perspectives

October 12, 2022  |  Jessica Woltering Manager, US Customs Compliance

container being loaded onto an ocean-going vessel 
Partner Government Agency Updates as the End of 2022 Approaches

With 2023 looming, it’s time to make sure to dot all of the i’s and cross all of the t’s. This article covers Partner Government Agency (PGA) updates, required renewals, and upcoming changes to make sure companies are prepared for the upcoming year.

Listen to this week's Trade & Tariff Perspective (recorded in English):

Audio file for partner government agency updates as the end of 2022 approaches
Lacey Act Phase Seven coming in 2023

The Animal and Plant Health Inspection Service (APHIS) section of the United States Department of Agriculture (USDA) administers the Lacey Act. The Lacey Act was enacted in 1900 and overhauled in 1981.

The main objective is wildlife protection through trafficking illegally taken wildlife, fish, and plant. The Lacey Act makes it illegal to make or submit any false record, account, label, or any false identification for any plant. It is also unlawful to import, export, transport, sell, receive, acquire, or purchase many plants through interstate or foreign commerce.

Starting in 2008, it became a requirement to declare certain plant and plant products when imported into the United States, and the enforcement of that import declaration started in 2009. There are four mandatory pieces of information for each Lacey Act declaration, and one conditional piece for recycled paper or paper products:

  1. Scientific name of the plant
  2. Value of the importation
  3. Quantity of the plant
  4. Name of the country where the plant was harvested
  5. Conditional: Recycled paper and paper products require the average percent of recycled content

An import declaration is not required for plants used exclusively as packaging material to support, protect, or carry another item—unless the packaging material itself is the item being imported.

The first six phases of the Lacey Act were implemented between April 2009 and October 2021. The APHIS Lacey Act Implementation Schedule breaks down the types of products and corresponding six-digit HTS, along with the dates each type of product was phased in.

There are two phases left to implement and APHIS is hoping for phase seven to start in late 2023 and be implemented by mid-2024, while phase eight would follow that. APHIS is still working on flagging phase seven HTS—however, it will include:

  • Chapter 94: All remaining non-composite plant products including wooden, wicker, and rattan furniture
  • Chapter 33: More essential oils
  • Chapter 45: Cork and cork products

Starting this month, APHIS will start its year of stakeholder outreach to inform the trade industry of the upcoming phase. APHIS stated the best-case scenario will be to publish a list of phase seven tariff codes in November or December 2023.

Phase eight will be the last phase and will cover all remaining composite materials, such as particleboard, books, wood pulp, and paper. APHIS is still working on clarifying definitions of products and manufacturing of plant material that make up composite goods with affected industries including paper and pulp companies.

The largest impact on importers will be to phase-in the remaining non-composite wood furniture that will require a Lacey Act import declaration form. Importers of wooden furniture, essential oils, and cork products should consider starting discussions with their suppliers to ensure there will be no interruption to their supply chains. The required PPQ 505 import declaration form can be found in the APHIS Forms Library.

The FDA updates for medical device companies

Medical device user fees are required for domestic and foreign owners or operators involved in producing and distributing medical devices intended for use in the United States, including devices imported for export only.

Who is required to register and pay yearly user fees?
Domestic establishments Foreign establishments 
Contract manufacturers and packagers Contract manufacturers and packagers
Contract sterilizers Contract sterilizers
Establishments in foreign trade zones involved with manufacturing, preparation, propagation, compounding, assembly, or processing devices intended for commercial distribution in the United States Custom device manufacturers, foreign manufacturers (including kit assemblers)
Initial importers Maintains complaint files as required under 21 CFR 820.198
Maintains complaint files as required under 21 CFR 820.198 Foreign exporters of devices located in a foreign country
Manufacturers of accessories or components packaged or labeled for commercial distribution for health-related purposes to an end user Manufacturers of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user
Manufacturers (including kit assemblers), manufacturers of custom devices, and U.S. manufacturers of export only devices Relabelers, repackagers, remanufacturers  
Relabelers, repackagers, remanufacturers, reproducers of single-use devices Reprocessors of single-use devices
Specification developers Specification developers

The U.S. Food and Drug Administration’s (FDA) fiscal year (FY) runs from October 1, 2022, through September 30, 2023. During that time medical device facilities must pay the medical device user fees to maintain their FDA compliant status. Because of inflation, medical device fees have increased from $5,546 in FY 2022 to $6,493 in FY 2023, and are required for each physical location that a company owns that handles certain roles for medical devices.

The FDA biennial food facility registration and renewal

The FDA continues to remind owners, operators, or agents who manufacture, process, pack, or hold human or animal food that the deadline to register or renew their food facilities is December 31, 2022. Renewals are free and required every two years to help the FDA identify locations and sources of foodborne illness outbreaks or potential bioterrorism incidents. Links to instructions and additional information are located on the FDA’s Constituent Update page.

A Data Universal Numbering System (DUNS) number is required to register a food facility. DUNS numbers are recognized as a unique facility identifier (UFI) which the FDA uses to verify a facility-specific address with the facility’s registration. DUNS numbers are assigned and managed by Dun & Bradstreet (D&B). Facilities unsure of their DUNS number or don’t know if they have one assigned can visit the D&B website.

National Marine Fisheries Service (NMFS) requirements

There is an updated Fisheries Certificate of Origin form (NOAA Form 370) that has been approved after the previous form expired on July 31, 2022. This form is required for the importation of any frozen and/or processed tuna and tuna products. It is not required for fresh tuna. The updated NOAA 370 form will expire on September 30, 2025.

Previously the signed hard copy of the National Oceanic and Atmospheric Administration (NOAA) Form 370 was required to be sent to the NOAA for release. New requirements allow the required documentation to be submitted prior to, or at the time of importation, via the ACE Document Imaging System (DIS).

Requirements for importing frozen and or processed tuna and tuna products include:

  • Fisheries Certificate of Origin NOAA Form 370
  • Captain’s Statement signed by the vessel captain declaring the tuna is certified as dolphin safe.
  • International Fisheries Trade Permit, in which brokers must submit the details and permit number with the PGA message set in ACE along with the customs entry. More details on the permit and how to apply are found on the Fisheries NOAA Fishing and Seafood Permits website.
  • International Dolphin Conservation Program (IDCP) Member Nation Certification
    • Mandatory for tuna harvested via a purse seine vessel with a carrying capacity more than 400 short tons (362.8 metric tons). Purse seines are fishing gear containing a large wall of netting used to capture a school of fish or fish in a large area.
    • Required for each fishing trip located in the eastern tropical Pacific Ocean.
  • Additional requirements are possible for India, Iran, Mozambique, Pakistan, Oman, Saudi Arabia, Sri Lanka, Tanzania, the United Arab Emirates, and Yemen. Those requirements can be found in the Federal Register Notice 81 FR 66625 effective November 28, 2016.

Additional NMFS and NOAA requirements and resources include:

  • Seafood Import and Export tool: Launched in late 2020, it helps the seafood trading industry identify importing and exporting requirements.
  • Tuna Tracking and Verification Program (TTVP): A NOAA monitoring program for cannery production and importation of all frozen and processed tuna products.
  • Seafood Import Monitoring Program (SIMP): A NOAA monitoring program in place for risk-based traceability. SIMP requires key data from point of harvest to entry into the United States and is required for almost half of U.S. seafood imports according to the NOAA.
How can C.H. Robinson help?

If you have questions or need guidance on how to import regulated products, our knowledgeable trade policy experts can assist with determining which PGA programs may apply to imported products and assist you with contacting these government agencies. As government agencies make updates and registrations are up for renewal, we will share that information via the Trade and Tariff articles or Client advisories. Connect with one of our trade policy experts to learn more.


Our information is compiled from a number of sources that to the best of our knowledge are accurate and correct. It is always the intent of our company to present accurate information. C.H. Robinson accepts no liability or responsibility for the information published herein.

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