Customs and Border Protection (CBP)

• Customs and Border Protection (CBP) has released 2022 Fourth Quarter Steel and Aluminum Bulletins reports for Argentina, Brazil, South Korea, and European Union member countries.

United States Department of Commerce (DOC)

• Department of Commerce’s Bureau of Industry and Security announced on February 3, 2020, in the U.S. District Court for the Southern District of Texas, Jose Ernesto Garcia (‘‘Garcia’’) was convicted of violating 18 U.S.C. 554(a). Specifically, Garcia was convicted of of one count of fraudulently and knowingly exporting and sending and attempting to export and send from the United States to Mexico various firearms.
• DOC’s Bureau of Industry and Security announced on August 12, 2020, in the U.S. District Court for the Western District of Texas, Luis Carlos Quintana-Saenz (‘‘Quintana-Saenz’’) was convicted of violating 18 U.S.C. 554(a). Specifically, Quintana-Saenz was convicted of knowingly and unlawfully attempting to export from the United States to Mexico approximately 3,860 rounds of ammunition of various calibers in violation of 18 U.S.C. 554.
• DOC’s Bureau of Industry and Security announced on July 18, 2019, in the U.S. District Court for the Southern District of Mississippi, Maurice Taylor (‘‘Taylor’’) was convicted of violating 18 U.S.C. 371. Specifically, Taylor was convicted of conspiring to purchase and export firearms to the United Kingdom, without obtaining the required export license from the U.S. Department of State, in violation of 18 U.S.C. 371.
• DOC will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice.
• DOC each year during the anniversary month of the publication of an antidumping or countervailing duty order, finding, or suspended investigation, an interested party may request, in accordance with 19 CFR 351.213, an administrative review of that antidumping or countervailing duty order, finding, or suspended investigation.
• DOC, in accordance with the Tariff Act of 1930, is automatically initiating the five-year reviews (Sunset Reviews) of the antidumping and countervailing duty (AD/CVD) order(s) and suspended investigation(s) listed.
• DOC’s NMFS Seafood Inspection Program is notifying program participants of a revised fee schedule.
• DOC is announcing in preparation for the 2022 International Commission for the Conservation of Atlantic Tunas (ICCAT) meeting, the Advisory Committee to the U.S. Section to ICCAT is announcing the convening of its fall meeting.
• DOC’s ‘‘Executive Order on America’s Supply Chains’’, issued on February 24, 2021, outlines U.S. policy objectives with respect to strengthening the resilience of America’s supply chains. The Executive Order directed relevant Secretaries to prepare reports on the supply chains for critical sectors and subsectors within either 100 days or 1 year of the Order.
• DOC announced that on July 6, 2020, in the U.S. District Court for the Central District of California, Mehdi Hashemi, a/k/a Eddie Hashemi (‘‘Hashemi’’), was convicted of violating the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq.) (‘‘IEEPA’’). Specifically, Hashemi was convicted of knowingly and willfully attempting to export Computer Numerical Control (‘‘CNC’’) machines 1 from the United States to Iran via the United Arab Emirates, a third country, in violation of the regulations that apply to exports to Iran.
• DOC finds that revoking the countervailing duty (CVD) order on steel concrete reinforcing bar (rebar) from the Republic of Turkey (Turkey) would likely lead to continuation or recurrence of countervailable subsidies.
• DOC, The International Trade Administration (ITA), announces the appointment of those individuals who have been selected to serve as members of ITA Performance Review Board.
• DOC announced that on January 10, 2020, in the U.S. District Court for the Western District of Texas, Bryan Villanueva-Valles (‘‘Villanueva-Valles’’) was convicted of violating 18 U.S.C. 554(a). Specifically, Villanueva-Valles was convicted of knowingly and unlawfully attempting to export, send, conceal and facilitate the transportation and concealment of various rifles and handguns from the United States to Mexico, in violation of 18 U.S.C. 554.
• DOC announced that on November 14, 2019, in the U.S. District Court for the Southern District of Florida, John James Peterson (‘‘Peterson’’) was convicted of violating 18 U.S.C. 371. Specifically, Peterson was convicted of knowingly and intentionally conspiring and agreeing with others known and unknown to export from the United States to Argentina, defense articles, namely, AR–15 assault rifles parts without first obtaining the required export control licenses or written approval from the Department of State.
• DOC announced that on January 6, 2020, in the U.S. District Court for the Southern District of Texas, Jose Luis Arevalo-Gonzalez (‘‘Arevalo-Gonzalez’’) was convicted of violating 18 U.S.C. 554(a). Specifically, Arevalo-Gonzalez was convicted of fraudulently and knowingly attempting to export from the United States to Mexico: one (1) Barret .50 caliber bolt; three (3) FA Cugir Romanian AK47; Seven (7) Century Arms VSKA AK47; one (1) Century Arms WASR AK47; and eighty-five (85) assorted magazines, all in violation of 18 U.S.C. 554.
• DOC announced that on July 6, 2020, in the U.S. District Court for the Central District of California, Mehdi Hashemi, a/k/a Eddie Hashemi (‘‘Hashemi’’), was convicted of violating the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq.) (‘‘IEEPA’’). Specifically, Hashemi was convicted of knowingly and willfully attempting to export Computer Numerical Control (‘‘CNC’’) machines 1 from the United States to Iran via the United Arab Emirates, a third country, in violation of the regulations that apply to exports to Iran.
• DOC announced that on February 26, 2020, in the U.S. District Court for the Western District of Texas, Tito Calderon Olvera (‘‘Olvera’’) was convicted of violating 18 U.S.C. 554(a). Specifically, Olvera was convicted of knowingly and unlawfully attempting to export from the United States to Mexico, a firearm namely a Glock ‘‘GEN 4,’’ .45 caliber handgun bearing serial number ‘‘YBX379;’’ five Glock magazines; and multiple rounds of .45 caliber ammunition, which are firearms as defined by the United States Munitions List, in violation of 18 U.S.C. 554.
• DOC preliminarily determines that certain producers/ exporters of certain cold-rolled steel flat products (cold-rolled steel) from the Republic of Korea (Korea) received countervailable subsidies during the period of review (POR) January 1, 2020, through December 31, 2020, while other producers/exporters (i.e., Hyundai Steel Co., Ltd., also referred to as Hyundai Steel Company (Hyundai Steel) and POSCO) received de minimis net countervailable subsidies during the POR.
• DOC is conducting an administrative review of the antidumping duty order on certain lined paper products from India, covering the period of review (POR), September 1, 2020, through August 31, 2021.
• DOC preliminarily determines that the companies subject to this countervailing duty (CVD) administrative review of certain steel racks and parts thereof (steel racks) from the People’s Republic of China (China) received countervailable subsidies during the period of review (POR), January 1, 2020 through December 31, 2020.
• DOC preliminarily determines that certain exporters under review sold certain steel racks and parts thereof (steel racks) from the People’s Republic of China (China) in the United States at prices below normal value (NV) during the period of review (POR) September 1, 2020, through August 31, 2021.
• DOC determines that the producers or exporters subject to this review did not make sales of circular welded carbon steel pipes and tubes (CWP) from Thailand at less than normal value during the period of review (POR) March 1, 2020, through February 29, 2021.
• DOC announced the United States Travel and Tourism Advisory Board (Board or TTAB) will hold a meeting on Wednesday, October 26, 2022. The Board advises the Secretary of Commerce on matters relating to the U.S. travel and tourism industry.
• DOC, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public’s reporting burden.

U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC)

• U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) on September 29, 2022, sanctioned an international network of companies involved in the sale of hundreds of millions of dollars’ worth of Iranian petrochemicals and petroleum products to end users in South and East Asia.
• OFAC on September 30, 2022, designated 14 persons in Russia’s military-industrial complex, including two international suppliers, three key leaders of Russia’s financial infrastructure, immediate family members of some of senior Russian officials, and 278 members of Russia’s legislature for enabling Russia’s sham referenda and attempt to annex sovereign Ukrainian territory.
• OFAC is amending the Libyan Sanctions Regulations and reissuing them in their entirety to further implement a February 25, 2011 Libya related Executive order and to implement an April 19, 2016 Libya related Executive order.
• OFAC is publishing the names of one or more persons and a vessel that have been placed on OFAC’s List of Specially Designated Nationals and Blocked Persons (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied.
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List based on OFAC’s determination that one or more applicable legal criteria were satisfied.
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied.
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied.
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied.

United States Court of International Trade (CIT)

• U.S. Court of International Trade (CIT) on September 19, 2022, issued its final judgment in Hyundai Steel Company v. United States, Court No. 20–03799, sustaining the U.S. Department of Commerce’s (Commerce) first remand results pertaining to the administrative review of the countervailing duty (CVD) order on certain hot-rolled steel flat products (HRS) from the Republic of Korea (Korea) covering the period of review (POR) January 1, 2017, through December 31, 2017.
• CIT held in Eteros Technologies USA, Inc. V. United States that a Washington state law allowing for the delivery, possession, or manufacturing of drug paraphernalia to process marijuana establishes an “authorization” to import drug paraphernalia, despite federal prohibition against the importation of marijuana.

United States International Trade Commission (USITC)

• The International Trade Commission (USITC) hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930 (‘‘the Act’’), as amended, to determine whether revocation of the antidumping duty orders on 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.
• USITC hereby gives notice that it has instituted a review pursuant to the Tariff Act of 1930 (‘‘the Act’’), as amended, to determine whether revocation of the antidumping duty order on fresh garlic from China would be likely to lead to continuation or recurrence of material injury.
• USITC hereby gives notice that it has instituted reviews pursuant to the Tariff Act of 1930 (‘‘the Act’’), as amended, to determine whether revocation of the antidumping duty orders on stilbenic optical brightening agents from China and Taiwan would be likely to lead to continuation or recurrence of material injury.
• USITC on the basis of the record 1 developed in the subject five-year review, determines, pursuant to the Tariff Act of 1930 (‘‘the Act’’), that revocation of the antidumping duty order on artists’ canvas from China would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.
• USITC hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701–TA–682 and 731–TA–1592–1593 (Preliminary) pursuant to the Tariff Act of 1930 (‘‘the Act’’) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of certain freight rail couplers and parts thereof from China and Mexico, provided for in subheadings 8607.30.10 and 7326.90.86 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China.
• USITC served notice in an investigation of certain centrifuge utility platform and falling film evaporator systems that all respondents named in the investigation have been terminated or found in default.
• USITC hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701–TA–682 and 731–TA–1592–1593 (Preliminary) pursuant to the Tariff Act of 1930 (‘‘the Act’’) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of certain freight rail couplers and parts thereof from China and Mexico, provided for in subheadings 8607.30.10 and 7326.90.86 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China.
• USITC serves notice in the matter of certain centrifuge utility platform and falling film evaporator systems that all respondents named in this investigation have been terminated or found in default.
• USITC hereby gives notice that the hearing in connection with the investigation will be held in-person at the U.S. International Trade Commission Building beginning at 9:30 a.m. on November 3, 2022.

United States Department of Treasury (USDT)

• The Department of the Treasury (USDT), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed or continuing information collections, as required by the Paperwork Reduction Act of 1995. , as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed or continuing information collections, as required by the Paperwork Reduction Act of 1995.

United States Office of Management and Budget (OMB)

• The Office of Management and Budget (OMB) Control Number for the Fisheries Certificate of Origin expired July 31, 2022. NMFS provided revised versions every 30 days until OMB approved as stipulated under the Paperwork Reduction Act. OMB has approved a Fisheries Certificate of Origin (FCO) with an expiration date of September 30, 2025.

United States Trade Policy Staff Committee (TPSC)

• The interagency Trade Policy Staff Committee (TPSC) sought public comments to assist the Office of the United States Trade Representative (USTR) in the preparation of its annual report to Congress on Russia’s implementation of its obligations as a Member of the World Trade Organization (WTO).

United States Food and Drug Administration (FDA)

• Food and Drug Administration (FDA) reminds Human and Animal Food Facilities to Register or Renew Registration between October 1 and December 31, 2022. Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2022.

United States Department of Energy (DOE)

• The U.S. Department of Energy (‘‘DOE’’) is initiating an effort to determine whether to amend the current energy conservation standards for metal halide lamp fixtures (‘‘MHLF’’). On October 25, 2021, DOE published a final determination concluding that energy conservation standards for MHLFs do not need to be amended because they are not economically justified.

Tech Crunch

• Tech Crunch is reporting that the AI-powered supply chain visibility platform Atlana closed on a $100 million Series B financing round bringing the startup’s total to $123 million.

Weaknesses in the Public Health Industrial Base

Critical technology shortages have been a focus of President Trump’s trade and industrial policies. In an October 2020 report on the topic, the Trump administration identified medical and public health technologies as a key sector in which the U.S. needs to do more to protect and cultivate its technological advantage. According to some analysts, the COVID-19 pandemic has demonstrated that the United States’ public health industrial base is overly reliant on imports for critical medical and pharmaceutical needs. The first few months of the pandemic were characterized by significant shortages of key medical supplies such as ventilators and personal protective equipment. However, this overreliance pre-dated the pandemic. For example, in October 2019, the U.S. Food and Drug Administration (“FDA”) estimated that the United States accounts for only 28 percent of global active pharmaceutical ingredient (“API”) manufacturing facilities and that 80 percent of APIs consumed in the United States are produced abroad, the majority in China and India.

Many countries (including the U.S.) reacted to the shortage of key supplies in the early months of the COVID-19 pandemic by imposing export restrictions. However, many mainstream economists have argued that placing restrictions on the exports of key medical goods can actually exacerbate shortages by preventing industry from efficiently meeting demand. Furthermore, export restrictions on critical medical goods can present moral dilemmas about how to best distribute essential medical goods. Chad Bown of the Peterson Institute for International Economics has argued that placing export restrictions on critical medical goods during a pandemic can disproportionately harm smaller and poorer countries that lack the industrial base to produce their own essential goods.

On August 6, 2020, President Trump issued Executive Order 13994, titled “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States.” The order sought to address concerns about weaknesses identified in the public health industrial base (“PHIB”) and creating systems to strengthen the ability of the United States to produce critical inputs and essential medicines domestically. Among other requirements, EO 13994 requires the Secretary of Commerce to submit a report to the Director of the Office of Management and Budget (“OMB”) among others by February 2, 2021 describing any change in the status of the public health industrial base and recommending initiatives to strengthen the public health industrial base. EO 13994 defines “public health industrial base” as the facilities and associated workforces within the United States, including research and development facilities, which help produce essential medicines, medical countermeasures, and critical inputs for the healthcare and public health sector. The PHIB includes all entities domestically manufacturing or producing medical products, including medical devices, medical equipment, medical countermeasures, and medications, pharmaceutical products, and other products designed to improve patient outcomes. This includes the manufacturing of components and materials that are essential to create end-item medical products, as well as ancillary supplies and disposable consumable products.

Comment Opportunity

On December 2, 2020, the U.S. Commerce Department’s Bureau of Industry and Security (“BIS”) announced in the Federal Register that it is seeking comments from the public to assist the Commerce Department in preparing its report. Comments are due on December 23, 2020. BIS requests comments recommending policies and actions to strengthen the public health industrial base. Specifically, BIS requests comments answering one or more of the following questions:

1. What is the condition of the current U.S. PHIB? Commenters in responding to this question are encouraged to reference their position in the PHIB (e.g., research and development facility, manufacturer, distributor, or consumer).
2. What policies and actions should the U.S. Government take to strengthen the PHIB in the United States?
3. What aspects or parts of the PHIB are most vulnerable during outbreaks of emerging infectious diseases?

• How likely might such an event be, how much of an impact might it have in manufacturing operations, and what mitigation measures might be most effective in offsetting these impacts?
• In responding to this question, commenters are encouraged to include any lessons learned from responding to COVID-19 or other historic pandemics, and the ramping up of U.S. capacity in various areas that did or did not occur to meet these challenges.

4. What aspects or parts of the PHIB are most vulnerable to chemical, biological, radiological, and nuclear (“CBRN”) events?

• How likely might such an event be; how much might it impact manufacturing operations; and what mitigation measures might be most effective in offsetting these impacts.
• In responding to this question, commenters are encouraged to include any lessons learned from responding to previous CBRN threats and the ramping up of U.S. capacity in various areas that did or did not occur to meet these challenges.

5. For the Essential Medicines, Medical Countermeasures, and Critical Inputs with which your organization is involved under the PHIB, for what percentage of these items are you dependent on foreign suppliers? In responding to this question, please address:

• Whether or not there are foreign dependencies in any part of your supply chain for critical inputs (e.g., active pharmaceutical ingredients (APIs)) or for finished products?
• Whether it would be possible to source these critical inputs and/or finished products from the United States, as well as how long you anticipate it would take to source these items from U.S. suppliers if your foreign supplier(s) was no longer available?

6. Are there any costs, regulatory or other factors that make it difficult or impossible to produce or source Essential Medicines, Medical Countermeasures, and/or Critical Inputs in the United States? In addressing this question, please also address:

• Any concerns that you may have regarding sourcing or producing these items in the United States, in contrast to sourcing or producing them outside the United States.
• Does your organization have mechanisms to determine whether Essential Medicines, Medical Countermeasures, and Critical Inputs are produced in the United States? What, if any, are the limitations to those mechanisms? Commenters are encouraged to be as specific as possible in their comments regarding the particular issues that may exist. For example, an example of a regulatory provision accompanied by a specific example of how the provision hinders domestic production is more helpful to Commerce than a statement that the regulatory environment in the United States discourages domestic production.
• How significant of a concern is “pricing” in being able to achieve maximum domestic production?

7. What is the U.S. Government doing or could do to foster private and public sector investment and innovation in the U.S. PHIB, including, for example, investments in upgrades to equipment, or the adoption of emerging technologies, and/or automation that would increase productivity and competitiveness. Should the U.S. Government do more to foster U.S. PHIB investment, particularly in automation and emerging technologies? If so, what policy actions should it undertake?
8. With respect to the U.S. PHIB, what are the challenges to investing in automation and other productivity-enhancing technologies in the United States as compared to moving operations abroad to lower-cost labor countries? Would increased investment in, or higher use of, more efficient and cost-effective automation and productivity enhancing technologies affect your decisions to source all or some of your Essential Medicines, Medical Countermeasures, and Critical Inputs in the United States?
9. Briefly assess whether the amount of federal funds spent on U.S. PHIB research and development (R&D) is adequate; if not, specify why spending should be increased or decreased. Which types of R&D projects, if adequately funded, would have the most impact on the competitiveness of the U.S. PHIB supply chain?
10. Briefly assess U.S. Federal procurement policy with respect to the U.S. PHIB and how it encourages or discourages investment in the PHIB. How should U.S. Federal procurement policy to make the PHIB more productive and more internationally competitive, as well as to encourage investment in automation and other emerging technologies?
11. What are the workforce challenges to strengthening the U.S. PHIB, and what are best practices or suggestions for how U.S. industry can overcome these challenges? What have you done to address these challenges? How might Start Printed Page 77430emerging technologies in the PHIB create new workforce training needs? Which skillsets will the job market most demand in the future?
12. How can the U.S. Government or the private sector help to accelerate the development of cost-effective and efficient domestic production of Essential Medicines and Medical Countermeasures and to have adequate redundancy built into the domestic supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs?
13. What are the three most important things that can be done by the U.S. Government or the private sector to ensure long-term demand for the Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States?
14. What are the three most important things that can be done by the U.S. Government or the private sector to create, maintain, and maximize domestic production capabilities for the Critical Inputs, Finished Drug Products, and Finished Devices that are essential to protect public safety and human health and to provide for the national defense?
15. How significant of a problem is trafficking of counterfeit Essential Medicines, Medical Countermeasures, and Critical Inputs over e-commerce platforms and from third party online vendors also involved in the U.S. Government procurement process? In responding to this question, commenters are encouraged to provide specific examples of how these practices may have undermined production in the United States, endangered U.S. citizens, or undermined the reliability of the U.S. supply chain.
16. How great of a threat is cybercrime or malicious cyber activity to your organization and other organizations that you depend on as part of your supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs? In addressing this question, commenters are encouraged to provide specific examples of how cyber threats (e.g., ransomware, distributed denial of service attacks (DDoS) and malware) have undermined production in the United States and the reliability of the U.S. supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs. How can the U.S. Government or the private sector strengthen the PHIB sector’s ability to prevent, detect, and recover from malicious cyber activity? To what extent, if any, does dependence on foreign suppliers increase your organization’s exposure to cybercrime or create additional burdens because of the complexities involved in dealing with different countries’ laws on cyber issues?
17. From your organization’s perspective, how dependent is the U.S. supply chain on foreign suppliers for items for use in Personal Protective Equipment (PPE)? In addressing this question, please address whether there are specific factors that undermine U.S. competitiveness in this area and provide any recommendations that your organization may have for reducing foreign dependency and increasing U.S. competitiveness. In addressing this question, specify whether your organization produces, sells or uses PPE.

Contact Us

Diaz Trade Law has extensive expertise on pharmaceutical trade matters and in submitting comments. Please reach out to us if you would like to submit comments to BIS informing the agency of your business’ recommendations for strengthening the U.S. public health industrial base. Diaz Trade Law can be reached at info@diaztradelaw.com and 305-456-3830.