Commerce Initiates Antidumping and Countervailing Duty Investigations of Certain Paper Shopping Bags...

from Cambodia, the People’s Republic of China, Colombia, India, Malaysia, Portugal, Taiwan, the Republic of Turkey, and the Socialist Republic of Vietnam

On June 21, 2023 , the U.S. Department of Commerce (Commerce) announced the initiation of antidumping duty (AD) and countervailing duty (CVD) investigations of certain paper shopping bags from Cambodia, the People’s Republic of China (China), Colombia, India, Malaysia, Portugal, Taiwan, the Republic of Turkey (Turkey), and the Socialist Republic of Vietnam (Vietnam).

APHIS Authorizes Imports of Fresh Leaves and Stems of Garland Chrysanthemum (Glebionis coronarium) from Mexico into the continental United States, Hawaii, Puerto Rico and the U.S. Virgin Islands

Washington, D.C., June 28, 2023 – The U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) is authorizing imports of fresh leaves and stems of garland chrysanthemum (Glebionis coronarium) from Mexico into the continental United States, Hawaii, Puerto Rico, and the U.S. Virgin Islands.

Based on a pest risk analysis, APHIS has determined applying one or more designated phytosanitary measures will successfully manage the risks of introducing or spreading plant pests or noxious weeds via the importation of fresh leaves and stems of garland chrysanthemum from Mexico.

This action becomes effective June 28, 2023.
https://www.aphis.usda.gov/aphis/newsroom/federal-register-posts/sa_by_date/sa-2023/garland-chrysanthemum-mexico

Global Business Identifier Initiative

Background

The Global Business Identifier (GBI) initiative seeks to develop a single identifier solution that will improve the U.S. government’s ability to pinpoint high-risk shipments and facilitate legitimate trade, create a “common language” between government and industry, and improve data quality and efficiency for identification, enforcement, and risk assessment.

GBI is a priority initiative under the Border Interagency Executive Council (BIEC), an executive advisory board made up of more than 50 U.S. Federal agencies with import and export responsibilities. In 2017, the BIEC established the GBI initiative to address issues with the Manufacturer/Shipper Identification Number, known as the “MID” and identify potential improvements. Though the MID served the U.S. government well since the 1990s, increasingly complex global supply chains necessitate better insight into where and how imported goods are manufactured, packaged, and exported.

Evaluative Proof of Concept (EPoC)

The BIEC developed an Evaluative Proof of Concept (EPoC) that will test three global identifiers’ ability and determine the optimal combination to help the U.S. Government identify main legal entity and ownership, specific business and global locations, and supply chain roles and functions.

To improve the U.S. government’s visibility into imports, CBP is partnering with three globally recognized global identifier companies: GS1 U.S., Dun and Bradstreet (D&B), and the Global Legal Entity Identifier Foundation (GLEIF) to test their identifiers’ ability to, alone or together, meet the U.S. government’s needs. Those identifiers are:

  1. Global Location Number (GLN)

  2. Data Universal Numbering System (DUNS)

  3. Legal Entity Identifier (LEI)

Through the GBI EPoC, CBP aims to leverage existing entity identifiers (GLN, DUNS, LEI) to develop a systematic, accurate, and efficient method for the trade to report, and the U.S. government to uniquely identify, legal business entities, their different business locations and addresses, and their various functions and supply chain roles. CBP will consider whether these three global identifiers, alone or together, ensure that CBP receives standardized trade data in a universally compatible trade language. Moreover, CBP will examine whether the identifiers submitted to CBP during the GBI EPoC can be easily verified, reducing uncertainties that may be associated with the information related to shipments of imported merchandise. Read More→
https://www.cbp.gov/trade/programs-administration/gbi

USITC MAKES DETERMINATIONS IN FIVE-YEAR (SUNSET) REVIEWS CONCERNING FROZEN WARMWATER SHRIMP FROM CHINA, INDIA, THAILAND, AND VIETNAM

The U.S. International Trade Commission (USITC) today determined that revoking the existing antidumping duty orders on frozen warmwater shrimp from China, India, Thailand, and Vietnam would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. 

As a result of the Commission’s affirmative determinations, the existing orders on imports of this product from China, India, Thailand, and Vietnam will remain in place. 

Chairman David S. Johanson and Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, Randolph J. Stayin, and Amy A. Karpel voted in the affirmative. 

Today’s action comes under the five-year (sunset) review process required by the Uruguay Round Agreements Act. See the attached page for background on these five-year (sunset) reviews.

The Commission’s public report Frozen Warmwater Shrimp from China, India, Thailand, and Vietnam (Inv. Nos. 731-TA-1064 and 1066-1068 (Third Review), USITC Publication 5432, June 2023) will contain the views of the Commission and information developed during the reviews. 

The report will be available by July 18, 2023; when available, it may be accessed on the USITC website at: https://www.usitc.gov/commission_publications_library.

BACKGROUND

The Uruguay Round Agreements Act requires the Department of Commerce to revoke an antidumping or countervailing duty order, or terminate a suspension agreement, after five years unless the Department of Commerce and the USITC determine that revoking the order or terminating the suspension agreement would be likely to lead to continuation or recurrence of dumping or subsidies (Commerce) and of material injury (USITC) within a reasonably foreseeable time.  Read More→

https://www.usitc.gov/press_room/news_release/2023/er0601_63963.htm

USITC ANALYZES MARKET CONDITIONS AND OUTLOOK FOR DISTRIBUTION SERVICES IN ANNUAL SERVICES REPORT

The United States was the world's largest services market and was the world’s leading exporter and importer of services in 2021, reports the U.S. International Trade Commission (USITC) in its new publication Recent Trends in U.S. Services Trade, 2023 Annual Report. As also noted in the report, preliminary data on U.S. cross-border services trade for 2022 show that total services exports were 15.9 percent higher in 2022 compared to 2021.

The USITC, an independent, nonpartisan, factfinding federal agency, compiles the report annually. Each year's report presents a qualitative and quantitative overview of U.S. trade in services and highlights some of the services sectors and geographic markets that contribute substantially to recent services trade performance.

This year’s report focuses on distribution services, including specific discussions on retail supply chains, e-commerce, logistics, warehousing, maritime shipping, port services, trucking and rail, air cargo, and express delivery via drones. Each section analyzes global market conditions in the industry and summarizes the industry’s outlook.

The report describes detailed trade in services via cross-border transactions through 2021 and via affiliate sales through 2020, as well as preliminary cross-border trade data for 2022 (latest available data). Several highlights are listed below.

  • In 2021, the services sector represented the largest sector of the U.S. economy, and the United States is the world’s top cross-border exporter and importer of services. U.S. exports of private services totaled $771.9 billion, whereas imports totaled $524.9 billion, resulting in a $247.0 billion trade surplus.

  • Within the services sector, sales by foreign affiliates of U.S. firms—the leading channel by which many U.S. services are delivered to foreign markets—totaled $1.6 trillion in 2020 while the value of services purchased from foreign-owned affiliates in the United States totaled $1.2 trillion. 

  • The distribution services sector includes a wide range of activities that facilitate the movement of goods through the supply chain from producer to end consumer. Distribution services accounted for 7.1 percent of total cross-border services exports and 17.4 percent of imports in 2021. They represented 27.4 percent of total sales by the foreign affiliates of U.S. firms and 29.5 percent of total purchases from the U.S. affiliates of foreign firms in 2020. Read More→

https://www.usitc.gov/press_room/news_release/2023/er0526_63943.htm

USITC MAKES DETERMINATIONS IN FIVE-YEAR (SUNSET) REVIEW CONCERNING BIODIESEL FROM ARGENTINA AND INDONESIA

The U.S. International Trade Commission (USITC) today determined that revocation of the existing antidumping and countervailing duty orders on biodiesel from Argentina and Indonesia would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. 

As a result of the Commission’s affirmative determinations, the existing orders on imports of this product from Argentina and Indonesia will remain in place. 

Chairman David S. Johanson and Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, Randolph J. Stayin, and Amy A. Karpel voted in the affirmative. 

Today’s action comes under the five-year (sunset) review process required by the Uruguay Round Agreements Act. See the attached page for background on these five-year (sunset) reviews.

The Commission’s public report Biodiesel from Argentina and Indonesia (Inv. Nos. 701-TA-571-572 and 731-TA-1347-1348 (Review), USITC Publication 5428, June 2023) will contain the views of the Commission and information developed during the reviews. 

The report will be available by June 30, 2023; when available, it may be accessed on the USITC website at: https://www.usitc.gov/commission_publications_library.

BACKGROUND

The Uruguay Round Agreements Act requires the Department of Commerce to revoke an antidumping or countervailing duty order, or terminate a suspension agreement, after five years unless the Department of Commerce and the USITC determine that revoking the order or terminating the suspension agreement would be likely to lead to continuation or recurrence of dumping or subsidies (Commerce) and of material injury (USITC) within a reasonably foreseeable time. Read More→

https://www.usitc.gov/press_room/news_release/2023/er0525_63934.htm

USITC INSTITUTES SECTION 337 INVESTIGATION OF CERTAIN BLOOD FLOW RESTRICTION DEVICES WITH ROTATABLE WINDLASSES AND COMPONENTS THEREOF

The U.S. International Trade Commission (USITC) voted to institute an investigation of certain blood flow restriction devices with rotatable windlasses and components thereof. The products at issue in the investigation are described in the Commission’s notice of investigation.

The investigation is based on a complaint filed by Composite Resources, Inc., of Rock Hill, SC, and North American Rescue, LLC, of Greer, SC, on April 24, 2023, and supplemented on April 27, 2023, May 11, 2023, and May 18, 2023. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain blood flow restriction devices with rotatable windlasses and components thereof that infringe patents, trademarks, and trade dress asserted by the complainants. The complainants request that the USITC issue a permanent general exclusion order, or in the alternative a permanent limited exclusion order, and permanent cease and desist orders. 

The USITC has identified the following respondents in this investigation: Read More→

https://www.usitc.gov/press_room/news_release/2023/er0524_63929.htm

Substantial Conclusion of Negotiations on Landmark IPEF Supply Chain Agreement

The proposed IPEF Supply Chain Agreement would make our supply chains more resilient and competitive, and would establish a framework for lasting cooperation on issues like workforce development, supply chain monitoring, investment promotion, and crisis response.

Completing negotiations on the IPEF Supply Chain Agreement is a major achievement in support of the President’s Indo-Pacific Strategy and a win for consumers, workers, and businesses in the United States and throughout the region.

The IPEF partners will now take steps, including further domestic consultations and a comprehensive legal review, to prepare a final text for signature.

Today, the United States joined its IPEF partners – Australia, Brunei, Fiji, India, Indonesia, Japan, Republic of Korea, Malaysia, New Zealand, the Philippines, Singapore, Thailand, and Vietnam – in announcing the substantial conclusion of negotiations on a landmark IPEF Supply Chain Agreement.

The proposed IPEF Supply Chain Agreement seeks to ensure that American workers, consumers, and businesses benefit from resilient, reliable, and efficient supply chains. It would support the President’s effort to revitalize U.S. manufacturing, facilitating the steady supply of the materials, components, and inputs that U.S. companies rely on to compete effectively on the world stage.

The agreement would foster coordination to identify potential supply chain challenges before they become widespread disruptions. Moreover, through the Agreement, partners would work collaboratively to increase the resilience, efficiency, productivity, sustainability, transparency, diversification, security, fairness, and inclusivity of our supply chains.

The IPEF Supply Chain Agreement would create an IPEF Supply Chain Council to oversee the development of sector-specific action plans designed to build resilience and competitiveness in critical sectors, including by helping companies identify and address supply chain vulnerabilities before they become significant bottlenecks.  

Through the proposed agreement, the IPEF partners would also create an IPEF Supply Chain Crisis Response Network that can serve as an emergency communications channel when one or more partners faces an acute supply chain crisis, facilitating more effective responses that can benefit American workers, businesses and consumers.  Read More→

https://www.commerce.gov/news/press-releases/2023/05/substantial-conclusion-negotiations-landmark-ipef-supply-chain

Argentina initiates WTO dispute complaint regarding US measures on certain tubular goods

Argentina has requested WTO dispute consultations with the United States regarding certain US anti-dumping measures on oil country tubular goods (OCTG) from Argentina as well as Section 771(7)(G) of the US Tariff Act of 1930. The request was circulated to WTO members on 25 May.

Argentina claims that the challenged measures are inconsistent with a number of provisions of the WTO's Anti-Dumping Agreement and the General Agreement on Tariffs and Trade 1994.  This is the third WTO dispute brought by Argentina relating to US anti-dumping measures on OCTG.

Further information is available in document WT/DS617/1

What is a request for consultations?

The request for consultations formally initiates a dispute in the WTO. Consultations give the parties an opportunity to discuss the matter and to find a satisfactory solution without proceeding further with litigation. After 60 days, if consultations have failed to resolve the dispute, the complainant may request adjudication by a panel.

Read More→ https://www.wto.org/english/news_e/news23_e/ds617rfc_24may23_e.htm

Bureau of Oceans and International Environmental and Scientific Affairs; Annual Determination and Certification of Shrimp-Harvesting Nations

ACTION:

Notice of annual determination and certification.

SUMMARY:

On May 12th, 2023, the Department of State determined and certified to Congress that wild-caught shrimp harvested in the following nations, particular fisheries of certain nations, and Hong Kong are eligible to enter the United States: Argentina, Australia (Northern Prawn Fishery, the Queensland East Coast Trawl Fishery, the Spencer Gulf, and the Torres Strait Prawn Fishery), the Bahamas, Belgium, Belize, Canada, Chile, Colombia, Costa Rica, Denmark, the Dominican Republic, Ecuador, El Salvador, Estonia, Fiji, France (French Guiana), Gabon, Germany, Guatemala, Guyana, Honduras, Iceland, Ireland, Italy (giant red shrimp), Jamaica, Japan (shrimp baskets in Hokkaido), Republic of Korea (mosquito nets), Mexico, the Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Panama, Peru, Russia, Spain (Mediterranean red shrimp), Sri Lanka, Suriname, Sweden, the United Kingdom, and Uruguay. For nations, economies, and fisheries not listed above, only shrimp harvested from aquaculture is eligible to enter the United States. All shrimp imports into the United States must be accompanied by the DS–2031 Shrimp Exporter's/Importer's Declaration. Read More→

https://www.federalregister.gov/documents/2023/05/25/2023-11115/bureau-of-oceans-and-international-environmental-and-scientific-affairs-annual-determination-and

Certain Freight Rail Couplers and Parts Thereof From the People's Republic of China: Final Affirmative Determination of Sales at Less-Than-Fair Value and Final Affirmative Determination

of Critical Circumstances

AGENCY:

Enforcement and Compliance, International Trade Administration, Department of Commerce.

SUMMARY:

The U.S. Department of Commerce (Commerce) determines that certain freight rail couplers and parts thereof (freight rail couplers) from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less-than-fair value (LTFV) during the period of investigation, January 1, 2022, through June 30, 2022. Read More→

https://www.federalregister.gov/documents/2023/05/30/2023-11358/certain-freight-rail-couplers-and-parts-thereof-from-the-peoples-republic-of-china-final-affirmative

USITC MAKES DETERMINATIONS IN FIVE-YEAR (SUNSET) REVIEW CONCERNING CARBON AND ALLOY SEAMLESS STANDARD, LINE, AND PRESSURE PIPE FROM JAPAN AND ROMANIA

The U.S. International Trade Commission (USITC) today determined that revocation of the existing the antidumping duty order on large-diameter carbon and alloy seamless standard, line, and pressure pipe from Japan and the antidumping duty orders on small-diameter carbon and alloy seamless standard, line, and pressure pipe from Japan and Romania would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. 

As a result of the Commission’s affirmative determinations, the existing orders on imports of these products from Japan and Romania will remain in place. 

Chairman David S. Johanson and Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, Randolph J. Stayin, and Amy A. Karpel voted in the affirmative. 

Today’s action comes under the five-year (sunset) review process required by the Uruguay Round Agreements Act. See the attached page for background on these five-year (sunset) reviews.

The Commission’s public report Carbon and Alloy Seamless Standard, Line, and Pressure Pipe from Japan and Romania (Inv. Nos. 731-TA-847 and 849 (Fourth Review), USITC Publication 5427, May 2023) will contain the views of the Commission and information developed during the reviews. 

The report will be available by June 23, 2023; when available, it may be accessed on the USITC website at: https://www.usitc.gov/commission_publications_library.

BACKGROUND

The Uruguay Round Agreements Act requires the Department of Commerce to revoke an antidumping or countervailing duty order, or terminate a suspension agreement, after five years unless the Department of Commerce and the USITC determine that revoking the order or terminating the suspension agreement would be likely to lead to continuation or recurrence of dumping or subsidies (Commerce) and of material injury (USITC) within a reasonably foreseeable time. 

The Commission’s institution notice in five-year reviews requests that interested parties file responses with the Commission concerning the likely effects of revoking the order under review as well as other information. Generally within 95 days from institution, the Commission will determine whether the responses it has received reflect an adequate or inadequate level of interest in a full review. If responses to the USITC’s notice of institution are adequate, or if other circumstances warrant a full review, the Commission conducts a full review, which includes a public hearing and issuance of questionnaires. Read More→ https://www.usitc.gov/press_room/news_release/2023/er0518_63916.htm

USITC RELEASES REPORT CONCERNING THE IMPACT OF U.S. FOREIGN TRADE ZONES AND SIMILAR PROGRAMS IN CANADA AND MEXICO

The U.S. International Commission (USITC) today released a report on the operation of the U.S. Foreign-Trade Zones (FTZ) program and similar programs (FTZ-type programs) in Canada and Mexico, as well as the impacts of these programs on employment and the cost-competitiveness of products of firms operating in U.S. FTZs. 

The investigation, Foreign Trade Zones (FTZs): Effects of FTZ Policies and Practices on U.S. Firms Operating in U.S. FTZs and Under Similar Programs in Canada and Mexico, was requested by the U.S. Trade Representative in a letter received on December 14, 2021. 

As requested, the USITC, an independent, nonpartisan, factfinding federal agency, reported on the operations of U.S. FTZs and FTZ-type programs, and the effects of relevant policies and practices on employment and the cost-competitiveness of goods produced in U.S. FTZs. As part of its investigation, the Commission conducted a survey of firms producing in U.S. FTZs and used the questionnaire results in its quantitative and qualitative analyses. Per the request, the report includes: 

  • An overview of economic activity in FTZs operating in the United States, Canada, and Mexico, including but not limited to employment, leading sectors, shipments, exports, and foreign direct investment in FTZs;

  • An overview of current FTZ policies and practices in the United States, Canada, and Mexico;

  • An analysis of the cost-competitiveness effects of current FTZ policies and praRead Morectices in the United States, Canada, and Mexico, including effects on relative production costs and U.S. employment; and

  • Case studies on the impact of U.S. FTZs and FTZ-type programs on the automotive, upholstered furniture manufacturing, petroleum refining, pharmaceutical manufacturing, and warehousing and distribution industries. 

Detailed highlights of the Commission's findings can be found in the report's Executive Summary. 

Findings include:

  • Central features of the U.S. FTZ program and FTZ-type programs in Canada and Mexico are the special tariff treatments, principally duty deferral, duty exemption, duty reduction, and duty drawback. 

  • The cost-competitiveness effects of the U.S. FTZ program and FTZ-type programs in Canada and Mexico are impacted by multiple factors, including the design of the programs, national tariff regimes and applicable rates of duty, other trade policies, and material sourcing and destination markets for firms’ shipments. 

USITC MAKES DETERMINATIONS IN FIVE-YEAR (SUNSET) REVIEW CONCERNING CERTAIN HARDWOOD PLYWOOD PRODUCTS FROM CHINA

The U.S. International Trade Commission (USITC) today determined that revocation of the existing antidumping and countervailing duty orders on certain hardwood plywood products (hardwood plywood) from China would be likely to lead to continuation or recurrence of material injury or threat of material injury within a reasonably foreseeable time. 

As a result of the Commission’s affirmative determinations, the existing orders on imports of this product from China will remain in place. 

Chairman David S. Johanson and Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, Randolph J. Stayin, and Amy A. Karpel voted in the affirmative. 

Today’s action comes under the five-year (sunset) review process required by the Uruguay Round Agreements Act. See the attached page for background on these five-year (sunset) reviews.

The Commission’s public report Hardwood Plywood from China (Inv. Nos. 701-TA-565 and 731-TA-1341 (Review), USITC Publication 5426, May 2023) will contain the views of the Commission and information developed during the reviews. 

The report will be available by June 16, 2023; when available, it may be accessed on the USITC website at: https://www.usitc.gov/commission_publications_library.

BACKGROUND

The Uruguay Round Agreements Act requires the Department of Commerce to revoke an antidumping or countervailing duty order, or terminate a suspension agreement, after five years unless the Department of Commerce and the USITC determine that revoking the order or terminating the suspension agreement would be likely to lead to continuation or recurrence of dumping or subsidies (Commerce) and of material injury (USITC) within a reasonably foreseeable time. 

The Commission’s institution notice in five-year reviews requests that interested parties file responses with the Commission concerning the likely effects of revoking the order under review as well as other information. Generally within 95 days from institution, the Commission will determine whether the responses it has received reflect an adequate or inadequate level of interest in a full review.  If responses to the USITC’s notice of institution are adequate, or if other circumstances warrant a full review, the Commission conducts a full review, which includes a public hearing and issuance of questionnaires. Read More→

https://www.usitc.gov/press_room/news_release/2023/er0511_63892.htm

Centers of Excellence and Expertise Directory

U.S. Customs and Border Protection (CBP) has designated new Centers of Excellence and Expertise (Centers) team codes within the Automated Commercial Environment (ACE) modules. 

  • The new team codes will follow an alphabetical format, e.g. ABC, where the first letter will represent a Center, and the secondary and tertiary letters will be used by the Centers to direct transactions to a specific work unit or team. 

  • Legacy numerical team codes will automatically be replaced on newly submitted entry summaries and phased out as existing entries liquidate.  As such, existing team codes will remain in effect for existing transactions. 

  • Please refer to CSMS #43089259 for additional details

APHIS Invites U.S. Stakeholders to Submit Topics on IPPC Standards and Implementation

The International Plant Protection Convention (IPPC) Secretariat has issued a call for topics for new plant health standards, revisions to adopted standards, and new tools that support the implementation of standards. IPPC standards play a critical role in safeguarding plant resources and creating new export opportunities for producers and exporters. Priority will be given to proposals that have a significant potential global impact and can be implemented at that level, contribute to the purpose of the IPPC, clearly identify problems that need to be resolved through the development or implementation of standards, and for which there is adequate technical information and expertise available to support the proposed initiative. Visit the IPPC web site to view the criteria for proposals, download the submission forms, and read about other requirements.

Send your completed submission forms no later than August 15, 2023, to Dr. Marina Zlotina, PPQ’s IPPC Technical Director at marina.a.zlotina@usda.gov.

If you have any questions about the IPPC call for proposals, email Dr. Zlotina. We look forward to receiving your ideas and suggestions for future IPPC work that may be a priority for your industry or organization.

Stay Involved!

U.S. stakeholders are vital to the work of the International Plant Protection Convention (IPPC) and the North American Plant Protection Organization (NAPPO). Your input on proposed projects, review of draft standards and documents, and participation in IPPC and NAPPO events ensures we are developing relevant standards that advance U.S. harmonization goals. Standards facilitate the safe trade of plants, plant products and other regulated articles, harmonize plant protection policies and practices among and between trading partners in North America and internationally, and provide a critical framework for addressing phytosanitary trade issues and negotiating market access requests.

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https://www.aphis.usda.gov/aphis/newsroom/stakeholder-info/stakeholder-messages/plant-health-news/ippc-standards-implementation-submission-by-aug-2023

FDA Transition Plan for Medical Devices Marketed Under EUA or an Enforcement Policy During the COVID-19 Pandemic

On 3/24/2023, the FDA posted the “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” and “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

These guidance documents will help prepare manufacturers and other stakeholders for the transition to normal operations and foster compliance with applicable regulatory requirements when EUAs and COVID-19-related enforcement policies are no longer in effect. 

EUA Devices

As stated in the “Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” FDA does not intend to object to the continued distribution of devices within the scope of the guidance during the transition period.

For medical devices that have been issued an EUA and the EUA has not been terminated, it is appropriate to continue to transmit the Intended Use Code (IUC) 940.000: Compassionate Use/Emergency Use Device when filing an entry. During the transition period and prior to the respective EUA’s termination date, registration, listing and premarket approval or clearance submission numbers may be optionally transmitted at the time of entry. This information may also be included within the shipping documents to expedite initial screening and further review of your entry.

Once an EUA is terminated, for medical devices that have a pre-market submission submitted and accepted by FDA, importers should transmit Intended Use Code (IUC) 081.001: Standard Import of a Device, and an appropriate FDA product code.  Under this IUC, the Affirmations of Compliance codes (AofC codes) for medical devices (such as the Registration, Listing, and Premarket numbers) should be submitted in the Automated Commercial Environment (ACE). You may transmit your 510(k) number for the pre-market submission under FDA review and upload a copy into the Import Trade Auxiliary Communications System (ITACS) of the notification indicating that your submission has been accepted. Read More→

https://content.govdelivery.com/bulletins/gd/USDHSCBP-35a3962?wgt_ref=USDHSCBP_WIDGET_2

PRESERVED MUSHROOMS FROM NETHERLANDS, POLAND, AND SPAIN INJURE U.S. INDUSTRY, SAYS USITC

The United States International Trade Commission (USITC) today determined that a U.S. industry is materially injured by reason of imports of preserved mushrooms from the Netherlands, Poland, and Spain that the U.S. Department of Commerce (Commerce) has determined are sold in the United States at less than fair value.

Chairman David S. Johanson and Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, Randolph J. Stayin, and Amy A. Karpel voted in the affirmative. 

As a result of the Commission’s affirmative determinations, Commerce will issue antidumping duty orders on imports of this product from the Netherlands, Poland, and Spain.

The Commission’s public report Preserved Mushrooms from the Netherlands, Poland, and Spain (Inv. Nos. 731-TA-1588-1590 (Final), USITC Publication 5419, May 2023) will contain the views of the Commission and information developed during the investigations.

The report will be available by June 8, 2023; when available, it may be accessed on the USITC website at: http://pubapps.usitc.gov/applications/publogs/qry_publication_loglist.asp.

UNITED STATES INTERNATIONAL TRADE COMMISSION

Washington, DC 20436

FACTUAL HIGHLIGHTS

Certain Preserved Mushrooms from the Netherlands, Poland, and Spain
Investigation Nos. 731-TA-1588-1590 (Final)
 

Product Description: Certain preserved mushrooms are mushrooms of the genus Agaricus that have been prepared or preserved by cleaning, blanching, and sometimes slicing or cutting. These mushrooms are then packed and heat sterilized in containers each holding a net drained weight of not more than 12 ounces (340.2 grams), including but not limited to cans or glass jars, in a suitable liquid medium, including but not limited to water, brine, butter, or butter sauce. The final form of certain preserved mushrooms can be either whole, sliced, or as stems and pieces. Read More→

https://www.usitc.gov/press_room/news_release/2023/er0427_63840.htm

USITC RELEASES REPORT CONCERNING THE AGOA PROGRAM AND ITS IMPACT ON SUB-SAHARAN AFRICA’S ECONOMIC DEVELOPMENT AND WORKERS

The U.S. International Trade Commission (USITC) today released its report African Growth and Opportunity Act (AGOA): Program Usage, Trends, and Sectoral Highlights (Inv. No. 332-589). This investigation and report were requested by the U.S. House of Representatives Committee on Ways and Means in a letter received on January 19, 2022. 

As requested, the USITC, an independent nonpartisan factfinding federal agency, conducted an investigation to gather information on and analyze the AGOA program’s usage and impact in sub-Saharan Africa (SSA). This report provides information and analysis on the background and requirements of the AGOA program, utilization rates, trends in U.S. imports under AGOA, and the impact of the program on regional integration, workers, underserved communities, economic development, job growth, and poverty reduction. The report also includes case studies on four industries present in SSA: apparel, cotton, cocoa, and certain chemicals. 

The report finds that the impact of the AGOA program on beneficiary countries can be substantial depending on the sector, especially apparel. Moreover, although the influence throughout SSA as a whole has been minimal, interviews by Commission staff, fieldwork, and some academic literature indicate that AGOA may have had a positive impact in key areas such as poverty reduction and job growth in some countries. The effect was found to be particularly important in the apparel sector and among underserved groups, such as women. Anecdotal evidence indicated that while meeting AGOA eligibility requirements created a positive impact on workers and poverty reduction, the loss of program eligibility due to failure to meet program requirements had a negative impact on beneficiary economies and regional integration. 

Additional highlights from the report include:

  • AGOA benefits accrue to a subset of countries and sectors within SSA. Over three-quarters of non-crude petroleum imports under AGOA originated from five countries during 2014–21: South Africa, Kenya, Lesotho, Madagascar, and Ethiopia. Countries with lower utilization rates typically have few exports to the United States in general, or their primary traded goods are not eligible for AGOA preferences or are already duty free under normal trade relations. Read More→

https://www.usitc.gov/press_room/news_release/2023/er0417_63816.htm