Federal Register Notices:
• Rules: Regulations To Improve Administration and Enforcement of Antidumping and Countervailing Duty Laws
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Cold-Rolled Steel Flat Products From Brazil, China, India, Japan, Korea, and the United Kingdom; Notice of Commission Determination To Conduct Full Five-Year Reviews
• Investigations; Determinations, Modifications, and Rulings, etc.: Certain Variable Speed Wind Turbine Generators and Components Thereof Notice of Request for Submissions on the Public Interest
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Tissue Paper Products From the People's Republic of China: Final Results of Expedited Sunset Review of the Antidumping Duty Order
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Aluminum Foil From the Republic of Turkey: Final Affirmative Countervailing Duty Determination
• Certain Aluminum Foil From the Sultanate of Oman: Final Affirmative Countervailing Duty Determination
• Determination of Sales at Less Than Fair Value: Certain Aluminum Foil From the Sultanate of Oman: Final Affirmative Determination of Sales at Less Than Fair Value
• Certain Aluminum Foil From the Russian Federation: Final Affirmative Determination of Sales at Less Than Fair Value
• Certain Aluminum Foil From the Republic of Turkey: Final Affirmative Determination of Sales at Less Than Fair Value
• Certain Aluminum Foil From the Republic of Armenia: Final Affirmative Determination of Sales at Less Than Fair Value
• Certain Aluminum Foil From Brazil: Final Affirmative Determination of Sales at Less Than Fair Value
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Emulsion Styrene-Butadiene Rubber From Brazil: Final Results of Antidumping Duty Administrative Review; 2019-2020
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Commerce Strengthens Rules to Fight Unfair Trade Practices - International Trade Administration
WASHINGTON - Today, the U.S. Department of Commerce announced modifications to its antidumping duty (AD) and countervailing duty (CVD) regulations, which will improve enforcement activities designed to defend U.S. companies from unfair and illegal trade practices.
“The Commerce Department is committed to safeguarding American workers, farmers, and other businesses from foreign actions that undermine free and fair trade,” said U.S. Secretary of Commerce Gina M. Raimondo. “These regulations represent the most comprehensive updates to trade enforcement in more than two decades. I thank U.S. industries and interagency partners who contributed through their review and input to this important rulemaking.”
The new regulations apply to various aspects of AD/CVD proceedings, including:
• Standalone rules governing circumvention inquiries and determinations;
• Rules for Commerce to assist U.S. Customs and Border Protection in combating duty evasion;
• Rules to prevent abuse of new shipper reviews;
• Rules updating the procedures and standards for scope inquiries and rulings; and
• Revised timeline for submitting comments pertaining to industry support.
These final regulations take into consideration comments from the public on the draft regulations, which were published on August 13, 2020. Certain parts of the rule will be effective within 30 days of the September 20, 2021 publication date (October 20, 2021) while other parts will be effective within 45 days (November 4, 2021), as detailed in the rule. For more information on the new regulations, please refer to the Federal Register notice and the updated AD/CVD FAQ section on trade.gov.
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San Pedro Bay Ports Announce New Measure to Speed Cargo Throughout - Port of Los Angeles
Expanded Night and Weekend Hours Planned at Ports of Long Beach, Los Angeles
SAN PEDRO, Calif. — Sept. 17, 2021 — Today, after consultation with multiple supply chain stakeholders and the U.S. Department of Transportation, the ports of Long Beach and Los Angeles announced bold new measures to improve freight movement and reduce delays through the ports as they continue to experience record volumes. These measures will enhance the ports’ landside operations to help meet the unprecedented growth in cargo volume moving through the San Pedro Bay.
Specifically, both ports will expand the hours during which trucks can pick up and return containers. Mario Cordero, Executive Director of the Port of Long Beach, announced that Long Beach will take the first step towards a 24/7 supply chain by maximizing nighttime operations. Port of Los Angeles Executive Director Gene Seroka announced that the Port of Los Angeles will expand weekend operating gate hours. Dubbed “Accelerate Cargo LA,” the Port of Los Angeles’ program will operate on a pilot basis to ensure that gate availability meets cargo demands and provides greater transparency to improve efficiency. In addition, both ports have called on marine terminal operators to incentivize the use of all available gate hours, especially night gates, to reduce congestion and maximize cargo throughput capacity.
Read further
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In the News:
• Why a Record Number of Container Ships are Backed Up Off the Coast of California - [Popular Science]
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OTEXA: Announcements
• [09/21/2021] – USTR invites comments to assist in identifying significant barriers to U.S. exports of goods and services, U.S. foreign direct investment, and the protection and enforcement of intellectual property rights for inclusion in the annual National Trade Estimate Report on Foreign Trade Barriers (NTE Report). Deadline for submission of comments is October 26, 2021. See the Federal Register notice for further details and instructions.
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Trade and Sustainability: Commission Proposes New EU Generalised Scheme of Preferences of Promote Sustainable Development in Low-Income Countries - European Commission
Today (9/22/21), the Commission has adopted the legislative proposal for the new EU's Generalised Scheme of Preferences (GSP) for the period 2024-2034. The Commission is proposing to improve some of the key features of the scheme to better respond to the evolving needs and challenges of GSP countries as well as reinforce the scheme's social, labour environmental and climate dimension.
The GSP Regulation is a unilateral trade tool that removes or reduces import duties from products coming into the EU from vulnerable low-income countries, supporting poverty eradication, sustainable development, and their participation in the global economy. The Commission's proposal makes the EU's GSP more focused on reducing poverty and increasing export opportunities for low-income countries. It aims to incentivise sustainable economic growth in low-income countries and offers new room for engagement on environmental and good governance issues.
The new GSP framework strengthens the EU's possibilities to use trade preferences to create economic opportunities and to advance sustainable development. The modernised framework also expands the grounds for the withdrawal of EU GSP preferences in case of serious and systematic violations. Beyond the core human rights and labour conventions already covered, the proposal incorporates environmental and good governance conventions.
Focus on those most in need
The GSP has several features to make sure trade preferences go to countries that need them the most and to support their sustainable development.
The new proposal further improves the current scheme by: Read further
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Justice Department Sues to Block Unprecedented Domestic Alliance Between American Airlines and JetBlue - U.S. Department of Justice
Alliance Eliminates Competition in New York and Boston and Harms Air Travelers Nationwide
The U.S. Department of Justice, together with Attorneys General in six states and the District of Columbia, sued today in the District of Massachusetts to block an unprecedented series of agreements between American Airlines and JetBlue through which the two airlines will consolidate their operations in Boston and New York City. The civil antitrust complaint alleges that this extensive combination, which they call the “Northeast Alliance,” will not only eliminate important competition in these cities, but will also harm air travelers across the country by significantly diminishing JetBlue’s incentive to compete with American elsewhere, further consolidating an already highly concentrated industry.
“Millions of consumers across America rely on air travel every day for work, to visit family, or to take vacations. Fair competition is essential to ensuring they can fly affordably and safely,” said Attorney General Merrick B. Garland. “In an industry where just four airlines control more than 80% of domestic air travel, American Airlines’ ‘alliance’ with JetBlue is, in fact, an unprecedented maneuver to further consolidate the industry. It would result in higher fares, fewer choices, and lower quality service if allowed to continue. The complaint filed today demonstrates the Justice Department’s commitment to ensuring economic opportunity and fairness by protecting consumers and competition.”
“The Northeast Alliance would eliminate significant competition in this important industry,” said Acting Assistant Attorney General Richard A. Powers of the Justice Department’s Antitrust Division. “This sweeping partnership is unprecedented among domestic airlines and amounts to a de facto merger between American and JetBlue in Boston and New York City. The impact on consumers extends far beyond Massachusetts and New York, as evidenced by the participation and our ongoing cooperation with Attorneys General from across the country, including Arizona, California, Florida, Massachusetts, Pennsylvania, Virginia and the District of Columbia, in this lawsuit.”
The Northeast Alliance combines American’s and JetBlue’s operations at four major airports: Boston Logan, John F. Kennedy, LaGuardia and Newark Liberty. The airlines have committed to coordinate “on all aspects” of network planning, including which routes to fly, when to fly them, who will fly them and what size planes to use for each flight. The two airlines will also share revenues earned at these airports, eliminating their incentives to compete with one another. The Northeast Alliance will also allow the parties to pool their gates and takeoff and landing authorizations, known as “slots.” According to the complaint, this unprecedented combination would raise prices and reduce choices for air passengers traveling to and from Boston and New York City.
As alleged in the complaint, American is the largest airline in the world. Just four airlines — American, along with Delta, United and Southwest — collectively control over 80% of domestic air travel. According to the complaint, American has relentlessly pursued a strategy of industry consolidation in the United States and around the world. Unable to combine with foreign airlines through formal mergers, American has instead pursued consolidation through a series of international joint ventures. The complaint alleges that JetBlue’s CEO stated, “it may look as if a dozen or more airlines [are] providing service. But when you go under the surface, it’s really just three big mega-alliances controlling 87% of the traffic…Consumers effectively have very little choice in markets where JVs have a stranglehold – and they also face higher fares.” The Justice Department alleges that American now seeks to import this strategy to domestic air travel.
According to the complaint, JetBlue has positioned itself as an important source of competition against American and the other large airlines, particularly in the northeast. According to the complaint, JetBlue’s reputation for lowering prices is so established that the industry refers to it as the “JetBlue Effect.” JetBlue’s own internal estimates show that it has saved customers at least $10 billion since its launch, offering lower fares and better service, and forcing its competitors to do the same.
According to the complaint, the Northeast Alliance will cause hundreds of millions of dollars in harm to air passengers across the country through higher fares and reduced choice. The complaint alleges that prior to entering the Northeast Alliance, JetBlue and American both planned to compete more intensely with one another, including in Boston and New York City, but also in other areas. If allowed to proceed, the Northeast Alliance would eliminate this important existing and future competition — creating, as American’s senior executives put it, “further domestic consolidation.” The Northeast Alliance will dampen American’s incentive to expand service elsewhere in its network and will significantly reduce JetBlue’s incentives to challenge its much larger partner across the country.
American Airlines Group Inc. is a Delaware corporation with its headquarters in Fort Worth, Texas. In 2019, it flew over 215 million passengers to approximately 365 locations worldwide, earning about $45 billion in revenues.
JetBlue Airways Corporation is a Delaware corporation with its headquarters in Long Island City, New York. In 2019, JetBlue flew over 42 million passengers to approximately 100 locations worldwide, earning about $8 billion in revenue.
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FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals - U.S. Food & Drug Administration
Today (9/22/21), the U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based products (ACTPs) understand current good manufacturing practice requirements (CGMPs) for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). CGMPs help prevent contamination and help ensure ACTP quality. If finalized, the recommendations are intended to support the development of promising and innovative products that can benefit animal health.
“ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals. We want to support manufacturers in the safe production of these promising products,” said Dr. Janet Woodcock, Acting Commissioner of the FDA. “It is important to note that the FDA is not imposing any new requirements on the manufacturers of ACTPs with these new draft guidance documents. These draft guidance documents, if finalized, are intended to assist manufacturers by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements. Our goal is to help manufacturers be successful in their efforts to develop innovative products that can benefit animal health.”
In the draft guidance, ACTPs are defined as products that contain, consist of, or are derived from cells or tissues that are intended for implantation, transplantation, infusion or transfer into an animal recipient. Furthermore, ACTPs refer to products that meet the definition of a new animal drug. In the draft guidance, ACTPs include both cell-based products and animal stem cell-based products. ACTPs are most commonly investigated for regenerative medicine applications because they have the potential to repair diseased or damaged tissues in animals through regeneration and healing. Currently, these products are most commonly investigated and used in companion animals including dogs, cats, and horses; however, ACTPs may be also be developed for use in other species.
All new animal drugs are required to be manufactured in accordance with CGMPs to ensure that such drugs meet the requirements of the FD&C Act for safety, and to have the identity, strength, quality, and purity characteristics which they purport to or are represented to possess. Because the manufacture of ACTPs present unique considerations for complying with CGMPs, the FDA is issuing two draft guidance documents for industry.
The first draft guidance, #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products” provides manufacturers of ACTPs with recommendations for meeting requirements for CGMPs. It addresses the methods, facilities and controls used for manufacturing ACTPs, including steps in recovery, processing, storage, labeling, packaging and distribution. The draft guidance also addresses methods for preventing contamination and ensuring quality of the ACTP during manufacturing.
The second draft guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products”, if finalized, will assist sponsors, firms or establishments that participate in the manufacture of ACTPs or perform any aspect of the ACTP donor eligibility determination. Selecting appropriate donors is critical to product quality and preventing the transmission of disease.
The concepts and principles in these draft guidance documents are consistent with the FDA’s Center for Biologics Evaluation and Research’s (CBER’s) regulations (21 CFR 1271 subparts C and D) and associated guidance documents for human cells, tissues, and cellular and tissue-based products.
“The FDA is seeking to improve transparency by engaging early in the development process and informing industry of our draft recommendations now, while the industry is still taking shape, as we are receiving applications seeking approval of ACTPs for use in animals,” said Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine. “As part of our commitment to fostering the development of innovative products in the most streamlined and efficient manner possible, we’re encouraging the ACTP industry to take advantage of our Veterinary Innovation Program, which is designed to assist product developers generate the appropriate data needed to support a new animal drug application.”
The FDA recommends sponsors and manufacturers of ACTPs contact the FDA early and often in the product development process to discuss considerations specific to the manufacture and approval of new animal drug products. The FDA has developed a process for these interactions through participation in its Veterinary Innovation Program, a program available to most ACTPs and aimed at providing greater certainty in the regulatory process, encouraging research and development, and supporting an efficient and predictable pathway to approval for these innovative products.
The FDA is accepting public comments on both draft guidance documents until November 22, 2021 so that we may consider comments before potentially issuing final guidance documents; however, comments on guidance documents are welcome at any time. Later this year, the FDA will also host a webinar to discuss the draft guidance documents for all interested stakeholders. Visit FDA.gov for more information.