United States and Switzerland Sign Pharmaceutical Good Manufacturing Practice Agreement - Office of US Trade Representative
WASHINGTON – The United States and Switzerland today signed the U.S.-Switzerland Pharmaceutical Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA). Deputy United States Trade Representative Jayme White, FDA Deputy Commissioner for Policy, Legislation, and International Affairs Andi Fristedt, State Secretary for the State Secretariat for Economic Affairs Helene Budliger Artieda, and Swissmedic Head of Management Services and International Affairs Dr. Jörg Schläpfer took part in the signing ceremony.
“This MRA will help streamline the movement of pharmaceutical goods and is a step in the right direction to create a safer, stronger, more reliable supply chain that minimizes drug shortages,” said Ambassador Jayme White.
Background
With supply chains for pharmaceutical products becoming more difficult to monitor given the complexities of foreign production and sourcing, this MRA provides an important policy tool to leverage cooperation with like-minded regulatory and trade authorities to improve oversight of key aspects of the drug supply chain. The COVID-19 pandemic has underscored the need for global regulatory collaboration, including through such approaches as MRAs.
Upon entry into force, this agreement allows U.S. and Swiss authorities to share documents from their routine GMP inspections of pharmaceutical manufacturing facilities, which will reduce unnecessary costs and duplicative efforts. Such efficiencies allow the two authorities to better exercise their respective regulatory discretion to re-allocate resources to where they are most needed, thereby ensuring that all drugs imported into the two countries are as safe as possible.
This MRA includes provisions with regard to:
• covered inspections and products;
• when the regulators intend to accept official GMP documents from the other;
• how the regulators will transmit official GMP documents to one another;
• under what circumstances each regulator expects to request that the other conduct inspections;
• under what circumstances a regulator may suspend the other for purposes of the MRA; and
the establishment of two different committees to facilitate the effective functioning of the MRA.
View the text of MRA
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Federal Register Notices:
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Cold-Drawn Mechanical Tubing of Carbon and Alloy Steel From India: Final Results of Antidumping Duty Administrative Review; 2020-2021
• Certain Quartz Surface Products From India: Final Results of Antidumping Duty Administrative Review; 2019-2021
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Steel Nails From Sri Lanka; Termination of Investigation
• Investigations; Determinations, Modifications, and Rulings, etc.: Emulsion Styrene-Butadiene Rubber From Czechia and Russia
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Preliminary Results of Countervailing Duty Administrative Review, Rescission and Intent To Rescind, in Part; 2020
• Certain Corrosion Inhibitors From the People's Republic of China: Notice of Final Results of Antidumping Duty Changed Circumstances Review
• Certain Cold-Drawn Mechanical Tubing of Carbon and Alloy Steel From Italy: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2020-2021
• Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of Review; 2020-2021
• Investigations; Determinations, Modifications, and Rulings, etc.: Components for Certain Environmentally-Protected LCD Digital Displays and Products Containing Same; Notice of Institution of Investigation
• Certain Robotic Floor Cleaning Devices and Components Thereof; Notice of a Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding; and Extension of the Target Date for Completion of the Investigation
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Chlorinated Isocyanurates From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2020-2021
• Steel Nails From India, Thailand, and Turkey; Supplemental Schedule for the Final Phase of Antidumping Duty Investigations
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Implementing the Uyghur Forced Labor Prevention Act: A Challenge Worth the Effort - U.S. Customs & Border Protection
The Uyghur Forced Labor Prevention Act, also known as the UFLPA, was signed into law by President Joe Biden on Dec. 23, 2021. This significant international trade legislation was the U.S. response to the Chinese government’s systemic use of forced labor against Uyghurs and other ethnic minorities in the Xinjiang Uyghur Autonomous Region, or XUAR, in the People’s Republic of China.
Almost 28 million people currently are victims of forced labor, according to the International Labour Organization, which they define as, “all work or service which is exacted from any person under the threat of a penalty and for which the person has not offered himself or herself voluntarily.” This also includes indentured labor and child labor.
The two CBP components primarily responsible for enforcing the Uyghur Forced Labor Prevention Act – the Office of Trade and the Office of Field Operations – began implementing the rebuttable presumption that went into effect on June 21, 2022 after months of intense preparation. That presumption means CBP will treat all goods produced entirely or in part in the XUAR as if they were produced with forced labor, and therefore, prohibited from entering the U.S. pursuant to Section 307 of the Tariff Act of 1930.
Personnel from across CBP work together to identify and interdict goods from, or made with inputs from, the Xinjiang Uyghur Autonomous Region in order to enforce the UFLPA. Goods produced with forced labor threaten American jobs by creating unfair economic competition, expose consumers to the risk of unknowingly purchasing goods made with forced labor, finance criminal organizations and result in atrocious human rights violations.
Enforcement is an ongoing challenge, as bad actors continue to seek to benefit financially by circumventing the UFLPA to introduce goods made with forced labor into U.S. markets. Case in point: XUAR jujubes.
Red dates, also known as jujubes, are small, pitted fruits popular throughout Asia. China produces 40% of the world’s supply, and the Uyghur Human Rights Project issued a report estimating that 50% of China’s jujubes originate in the XUAR. The report said jujubes produced in XUAR continued to turn up on U.S. supermarket shelves even after UFLPA implementation.
The XUAR was financially benefiting from the circumvention of the UFLPA on the sales of jujubes, according to the Uyghur Human Rights Project report, despite CBP’s enforcement efforts. When international trade analysts Diana Sassmann and Erika Ribeiro of CBP Office of Trade’s New York National Threat Analysis Center saw the Uyghur Human Rights Project report, they immediately sprang into action, and CBP initiated a dynamic and collaborative approach to ensure the correct actions were taken.
Sassmann and Ribeiro have worked on the agency’s XUAR portfolio for nearly three years: first on the forced labor Withhold Release Orders linked to cotton from the XUAR and the Xinjiang Production and Construction Corps, and later on the development and implementation of the Department of Homeland Security’s UFLPA Strategy. They already knew that much of China’s jujube supply originates in the XUAR and were actively identifying producers there. But entities located outside of the region that export XUAR-origin jujubes were elusive to pin down.
“What we’ve noticed when we’re looking into where XUAR dates are coming from, is that it looks like they’re harvested in the XUAR but shipped from other areas,” Ribeiro explained. She said this is symptomatic of the difficulty of forced labor targeting – particularly in China.
Sassmann noted that it’s a common problem with agricultural products in general. “It’s not unusual … to have something grown on a farm in one place, and the packing house is somewhere else. This is part of the challenge.” Sassmann said that this practice isn’t inherently illegal. In fact, it’s normal practice in the agriculture industry. But it does make identifying the origin of goods more challenging. She said with the UFLPA, “it has become normal operating procedure [for Chinese producers] to obfuscate the origin of goods from the XUAR,” making work for CBP employees more difficult.
This case illustrates why reports from civil society, non-governmental organizations and industry play a major role in CBP’s work to keep goods made with forced labor out of the U.S. Sassmann and Ribeiro, armed with the information provided in the Uyghur Human Rights Project report and intelligence gleaned from other sources, identified several inbound shipments that they suspected contained jujubes originating in the XUAR – including one at the nearby Port of Newark, New Jersey, that arrived that very day.
Sassmann and Ribeiro acted quickly, reaching out to their colleagues at the Port of Newark to request they hold the shipment for inspection. Michael Vernon, a deputy chief at the Port of Newark, promptly agreed and worked with import specialists from the Agriculture and Prepared Products Center of Excellence and Expertise, or APP Center, to examine the shipment and its accompanying documentation.
The APP Center has a network of staff located across the U.S. and are therefore well positioned to assist the officers at various ports of entry, conducting joint examinations, and providing photos of the labeling to be translated. The APP Center sends examination results back to the port and CBP’s Forced Labor Division depending upon the outcome of the review.
APP Center import specialists Eugene Gambardella, Ethan Kemler and Paul Guastella, as a part of their examination in this case, photographed suspicious labels and markings on the shipment’s packaging as well as the merchandise itself before enlisting the expertise and assistance of Altungul Emet, a translator who is fluent in Mandarin and Uyghur.
Emet works in CBP’s Civil Enforcement Division and has worked closely with the New York National Threat Analysis Center on UFLPA enforcement. She grew up in Hami, a city in the eastern part of the XUAR, so supporting CBP’s UFLPA enforcement efforts really hit home. “As an American with a Uyghur background, I was proud that my skills could contribute to this mission to support the UFLPA, and to be part of this tireless CBP team. I am clearly in the right place at the right time,” she said.
Emet identified the logo of the Xinjiang Production and Construction Corps, as well as other references to the XUAR, on the packaging after examining the photographs from the port. This triggered an immediate red flag since the Xinjiang Production and Construction Corps is a paramilitary organization that has been sanctioned by the U.S. for several years, even before UFLPA implementation began, and is on the UFLPA Entity List, a list of entities in the XUAR known to use forced labor.
The Port of Newark had all the evidence it needed to detain the shipment with this new piece of the puzzle in place. The examination and action in New York and New Jersey triggered a domino effect on the other side of the country, where additional shipments were intercepted and examined in Los Angeles and Oakland, California – several bearing markings indicating links to the Xinjiang Uyghur Autonomous Region.
With increasingly complex supply chains that span the globe, the UFLPA presents unique enforcement challenges to CBP personnel whose job it is to prevent goods produced with forced labor, in any part of the supply chain, from reaching U.S. shelves. Dina Amato, director of CBP’s APP Center, acknowledges the difficulty: “Everything about CBP’s work is complex and has challenges – specifically, the layers within the supply chain and the complex documents we must review to make a determination of admissibility,” she said. “I truly believe it is how we learn from these challenges and overcome them that turns them into successes.”
“What could be more rewarding than coming to work every day, partnering with the dedicated men and women from CBP to identify the needles in the haystack, and then stopping goods produced using forced labor from entering the United States? Every aspect of this process is rewarding because forced labor is about people in need. And CBP forges a path forward,” Amato said.
Enforcing these laws is not just their job to CBP employees, it is the right thing to do. Forced labor spans every region of the world according to the U.S. Department of Labor. CBP’s goal is not only to eliminate forced labor from U.S. supply chains, but to curtail the practice altogether – a mission employees firmly stand behind. “CBP is leading the way in stopping profiteering from forced labor and human misery,” said Evan Thomas, a national import specialist assigned to CBP’s National Commodity Specialist Division who has worked extensively on UFLPA enforcement. He went on to say this is the most rewarding part of his job.
There is hope for real change in working conditions for millions of people throughout the world with the dedicated, deeply knowledgeable and determined CBP employees on the case.
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Almost 5,000 Earrings Retailing for $1.3M Seized by Louisville CBP - U.S. Customs & Border Protection
LOUISVILLE, Ky — U.S. Customs and Border Protection (CBP) officers in Louisville are seeing nightly counterfeit jewelry shipments arriving from locations known to produce fakes. On January 2, Louisville CBP seized a shipment of jewelry deemed to be counterfeit by CBP’s Centers of Excellence and Expertise, the agency’s trade experts.
CBP officers examined the shipment to determine the admissibility of the goods and discovered the shipment contained 4,920 pairs of earrings with Chanel logos. While the shipment was manifested as stud earrings, they were seized for infringing Chanel’s protected trademarks. The earrings, arriving from China and heading to Maryland, would have been worth a total of $1.37 million had they been genuine.
“This just goes to show you how criminals are using express consignment facilities to ship their items to unsuspecting consumers, damaging our economy,” said LaFonda D. Sutton-Burke, Director, Field Operations-Chicago Field Office. “I want to congratulate our Officers for their outstanding job. CBP is the first line of defense, and we will continue to protect the safety of consumers.”
The rapid growth of e-commerce enables consumers to search for and easily purchase millions of products through online vendors, but this easy access gives counterfeit and pirated goods more ways to enter the U.S. economy. U.S. consumers spend more than $100 billion every year on intellectual property rights (IPR) infringing goods, falling victim to approximately 20% of the counterfeits that are illegally sold worldwide. Counterfeit costume jewelry bearing famous brands such as Chanel have been found to contain lead and other toxic materials that are dangerous to human health.
Intellectual property is a critical component of the U.S. economy, and Thomas Mahn, Louisville Port Director, emphasized the necessary role CBP plays in protecting the economy and consumer safety and health.
“Legitimate trade strengthens our economy,” said Mahn, “but counterfeit and pirated goods threaten American jobs and innovation. Protecting intellectual property rights remains a priority trade issue for CBP, and our officers are committed to protecting American consumers and our economic security.”
CBP has established an educational initiative to raise consumer awareness about the consequences and dangers associated with purchasing counterfeit and pirated goods online or in stores. More information about that initiative is available at www.cbp.gov/fakegoodsrealdangers.
Brand owners wishing to partner with CBP to prevent the importation of counterfeit and substandard goods should visit https://iprr.cbp.gov/s/ for information about the e-Recordation program.
For more ways to protect yourself from counterfeit and pirated goods, visit https://www.stopfakes.gov/.
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United States and Japan Launch Task Force to Promote Human Rights and International Labor Standards in Supply Chains - Office of the U.S. Trade Representative
WASHINGTON – United States Trade Representative Katherine Tai and Japan's Minister for Economy, Trade, and Industry Nishimura Yasutoshi signed a Memorandum of Cooperation (MOC) to launch a Task Force on the Promotion of Human Rights and International Labor Standards in Supply Chains.
The United States and Japan are working together through the U.S.- Japan Partnership on Trade to advance a common trade agenda, which includes promoting respect for internationally-recognized labor rights. The Task Force was established under the U.S.-Japan Partnership on Trade.
The Task Force represents an opportunity for the United States and Japan to protect and promote human rights and internationally recognized labor rights, including prohibiting the use of forced labor in supply chains through trade policy. Through the Task Force, the United States and Japan will exchange information on relevant laws, policies, and guidance; facilitate stakeholder dialogues with businesses and worker organizations; and promote best practices for human rights and internally recognized labor rights due diligence. These areas of cooperation are designed to protect workers and enhance predictability and clarity for businesses as they seek to contribute to resilient and sustainable supply chains.
“From their leadership in the development of the Group of 7 Trade Ministers’ Statement on Forced Labor to their first-ever release of human rights due diligence guidelines for responsible supply chains to their commitment to carry out shared principles to combat forced labor with the United States and the European Union, the Government of Japan has consistently been a trusted partner in the fight to promote workers’ rights and drive the race to the top in trade,” said Ambassador Katherine Tai. “The launch of this Task Force is another example of how trade can be a force for good throughout the world. Developing new tools that bring together the combined expertise of agencies across the Governments of the United States and Japan will help contribute to tackling worker exploitation in global supply chains.”
On the United States’ side, the Task Force is comprised of the Office of the United States Trade Representative, Department of State, Department of Commerce, Department of Health and Human Services, Department of Labor, Department of Homeland Security, U.S. Customs and Border Protection and Immigration and Customs Enforcement, the U.S. Agency for International Development, and other government agencies, as appropriate.
On Japan’s side, the Task Force is comprised of the Ministry of Economy, Trade, and Industry and Ministry of Foreign Affairs and other ministries as appropriate.
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USITC Makes Determinations in Five-Year (Sunset) Reviews Concerning Carbon and Alloy Steel Cut-to-Length Plate from Austria, Belgium, Brazil, China, France, Germany, Italy - U.S. International Trade Commission
The U.S. International Trade Commission (USITC) today determined that revoking the existing countervailing duty orders on imports of carbon and alloy steel cut-to-length plate from China and South Korea and the existing antidumping duty orders on imports of carbon and alloy steel cut-to-length plate from Austria, Belgium, China, France, Germany, Italy, Japan, South Africa, South Korea, Taiwan, and Turkey 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 Austria, Belgium, China, France, Germany, Italy, Japan, South Africa, South Korea, Taiwan, and Turkey 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 for the reviews involving Austria, Belgium, China, France, Germany, Italy, Japan, South Africa, South Korea, Taiwan, and Turkey.
The Commission further determined that revocation of the existing antidumping duty order on imports of carbon and alloy steel cut-to-length plate from Brazil would not be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
As a result of the Commission’s negative determination, the existing antidumping duty order on imports of this product from Brazil will be revoked.
Chairman Johanson and Commissioners Kearns and Karpel voted in the negative for the review involving Brazil. Commissioners Schmidtlein and Stayin voted in the affirmative for the review involving Brazil.
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 Steel Cut-to-Length Plate from Austria, Belgium, Brazil, China, France, Germany, Italy, Japan, South Africa, South Korea, Taiwan, and Turkey (Inv. Nos. 701-TA-560-561 and 731-TA-1317-1328 (Review), USITC Publication 5399, January 2023) will contain the views of the Commission and information developed during the reviews.
The report will be available by February 14, 2023; when available, it may be accessed on the USITC website at: https://www.usitc.gov/commission_publications_library.
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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.
The Commission generally does not hold a hearing or conduct further investigative activities in expedited reviews. Commissioners base their injury determination in expedited reviews on the facts available, including the Commission’s prior injury and review determinations, responses received to its notice of institution, data collected by staff in connection with the review, and information provided by the Department of Commerce.
The five-year (sunset) reviews concerning Carbon and Alloy Steel Cut-to-Length Plate from Austria, Belgium, Brazil, China, France, Germany, Italy, Japan, South Africa, South Korea, Taiwan, and Turkey (Review) (Full) were instituted on December 1, 2021.
On March 7, 2022, the Commission voted to conduct full reviews. Chairman David S. Johanson and Commissioners Rhonda K. Schmidtlein, Jason E. Kearns, Randolph J. Stayin, and Amy A. Karpel concluded that, for Belgium, China, and South Africa, the domestic group responses were adequate and the respondent group responses were inadequate. They concluded that, for Austria, Brazil, France, Germany, Italy, Japan, South Korea, Taiwan, and Turkey, the domestic group responses and the respondent group responses were adequate and voted for full reviews.
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Don't Answer Another Online Quiz Question Until You Read This - Federal Trade Commission
What do the model of your first car, your favorite hobby, and the high school you attended have in common? If you said they’re questions commonly used for online account security and online quizzes, you’re correct! Before you take a quiz to find out which Marvel character you are, ask yourself: Do I know who’s gathering this information about me — or what they plan to do with it?
Personality tests, quick surveys, and other types of online quizzes ask seemingly harmless questions, but the more information you share, the more you risk it being misused. Scammers could do a lot of damage with just a few answers that give away your personal information. We’ve heard about scammers phishing for answers to security question data through quizzes. They use your quiz answers to try and reset your accounts, letting them steal your bank and other account information. Some scammers hack social media accounts and send malware links to friends of the hacked account holder under the guise of sharing a quiz.
One major way to protect your personal information — in addition to maintaining strong passwords and using multi-factor authentication — is to steer clear of online quizzes…or just don’t answer them truthfully. As for accounts that require actual security questions, treat them like additional passwords and use random answers, preferably long ones, for those too. Asked to enter your mother’s maiden name? Say it’s something else: Parmesan or another word you’ll remember. Or use a password manager to store a unique answer. This way, scammers won’t be able to use information they find to steal your identity.
If you suspect that an online quiz is a phishing scam, tell a friend. Then, report it to the FTC at ReportFraud.ftc.gov.