Trade and Customs Updates
FDA & EU Announce Mutual Recognition of GMP
On 31 May 2023, the US Food and Drug Administration (FDA) and the European Union (EU) announced their decision to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary

pharmaceuticals (also called “animal drugs”). This MRA entered into force on November 1, 2017, but initially included only pharmaceuticals intended for human use. Today’s action to include animal drugs in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the U.S. and EU regulatory systems.
TTB to Extend Comment Period on Trade Practices Regulations

TTB announced it is extending the comment period for Notice No. 216, Consideration of Updates to Trade Practice Regulations, for an additional 30 days, until 07 July 2023. An official notice announcing that final extension of the comment period appeared in the Federal Register on Monday, 05 June. TTB is
taking this action in response to comments received concerning an extension of the comment period for Notice No. 216.
In November 2022, TTB published Notice No. 216, an advance notice of proposed rulemaking (ANPRM), in response to the Treasury Department’s report on competition in the markets for beer, wine, and spirits, which recommended that TTB consider revisions to its trade practice regulations. Through that ANPRM, TTB is seeking public comment from industry members, consumers, and other interested parties to assist us in determining whether TTB should proceed with regulatory initiatives concerning the issues described in that ANPRM related to the Federal Alcohol Administration Act’s exclusive outlet, tied house, commercial bribery, and consignment sales regulations.
To view all documents and comments received to date related to the ANPRM, see Docket No. TTB-2022-0011 at Regulations.gov. To submit comments electronically, use the comment form for Notice No. 216 posted at Regulations.gov. To submit comments by postal mail, see the instructions in the notice.
Additional Documentation:
The US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announces the inclusion of a Cut Flower Name Validation List.
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announces the inclusion of a Cut Flower Name Validation List to verify spellings on the APHIS Core Message Set website. The list provides Genus, Species, and Subspecies names along with corresponding common names.

Users can download and integrate the category AP0800 (cut flowers) list into their database to standardize submissions to USDA APHIS. This new asset increases compliance with APHIS Core Message Set policies and APHIS regulations, facilitates the import process, and improves the movement of cargo into US commerce.
The list also provides the acceptable spellings for listed names and provides the corresponding Integrated Taxonomic Information Systems (ITIS) Taxonomic Serial Number (TSN) and APHIS ID (APID) number. It does not indicate commodities that may or may not be admissible. If the Genus, Species, or Subspecies does not appear on this list, customs brokers and importers should use the format that appears on the associated phytosanitary certificate and commercial invoice. PPQ will update the list as necessary and provide the date of the most recent update.
As a reminder, when reporting AP0800, the units of measure, packing level one should be reported as STM (stem), and packing level two as BX (box).
Suspension of Section 232 Duties on Steel Articles from Ukraine Extended

232 duties on steel articles from Ukraine were suspended as of June 1, 2022. The suspension was recently extended through June 1,2024 and now also applies to steel from the EU, with a melt and pour country of the Ukraine. The announcement of the extension was made on May 31, 2023. In guidance provided under
CSMS # 56517371 CBP notes:
“For imports of steel and steel derivative articles from Ukraine, including steel articles from the European Union where the steel is melted and poured in Ukraine, importers are required to submit the certificate of origin from Ukraine to CBP’s Document Imaging System (DIS). Imports of such steel and steel derivative articles that are not accompanied by certificates of origin from Ukraine are subject to the 25 percent ad valorem duty. Importers should also submit the steel mill certificate required by 19 CFR 141.89.”
Having the certificate of origin will impact the ability to file for 232 exemptions per the associated provisional tariffs:
- For steel/steel derivative articles from Ukraine with a certificate of origin:
- No Chapter 99 tariff will be transmitted for the section 232 duties.
- For steel/steel derivative articles from Ukraine without a certificate of origin, the additional 25% will apply under:
- 9903.81.83: Iron or steel products described in subdivision (b) of note 16 to the subchapter, when such are products of Ukraine and are not accompanied by certificates of origin.
- 9903.81.84: Derivative iron or steel products enumerated in note 16(a)(ii) to the subchapter, when such good are the products of Ukraine and are not accompanied by certificates of origin.
- Steel articles from the European Union melted and poured in Ukraine with a certificate of origin from Ukraine:
- 9903.81.82: Iron or steel products described in subdivision (b) of note 16 to the subchapter that are melted and poured in Ukraine and are products of the member countries of the European Union enumerated in U.S. note 16(f).
- Steel articles from the European Union melted and poured in Ukraine without a certificate of origin from Ukraine:
- 9903.80.01: Products of iron or steel provided for in the tariff headings or subheadings enumerated in note 16.
Those EU steel articles where the steel was melted and poured in the Ukraine are not eligible for the EU steel tariff-rate quota.
CBP Provides Guidance on Section 301 China Covid Product Exclusion Extensions
In CSMS # 56517869 CBP provided guidance on the 16-day transition period for all 81 medical-care product COVID exclusions, extending them through May 31, 2023, and the further extension of 77 of the COVID exclusions through September 30, 2023.

In the guidance, CBP notes that the “the functionality for the acceptance of the COVID exclusion extensions were available in the Automated Commercial Environment (ACE) as of 7 am eastern daylight time, May 18, 2023.” With the exclusions having expired at that point CBP states “Importers who entered Chinese goods subject to product exclusions and paid Section 301 duties between May 15, 2023, through May 18, 2023, should file Post Summary Corrections (PSCs) correcting the entry summary line to remove HTS 9903.88.01, 9903.88.02, 9903.88.03, 9903.88.04 and 9903.88.15 to obtain refunds of duties paid under HTS 9903.88.66.
As of June 1, 2023 the 77 extended exclusions are covered under 9903.88.68. (88 FR 31580)
The list also provides the acceptable spellings for listed names and provides the corresponding Integrated Taxonomic Information Systems (ITIS) Taxonomic Serial Number (TSN) and APHIS ID (APID) number. It does not indicate commodities that may or may not be admissible. If the Genus, Species, or Subspecies does not appear on this list, customs brokers and importers should use the format that appears on the associated phytosanitary certificate and commercial invoice. PPQ will update the list as necessary and provide the date of the most recent update.
As a reminder, when reporting AP0800, the units of measure, packing level one should be reported as STM (stem), and packing level two as BX (box).
Trade and Customs Reminders & Events

NCSD June 2023 Webinars
Meat Products of Chapters 2 & 16 – June 20, 2023
Essential Oils, Perfumes, and Other Preparations of Chapter 33 – June 22, 2023
Never Screw Up Fasteners of 7318 Again! – June 27, 2023