GENEVA – Deputy United State Representative and Chief of Mission (Geneva) María Pagán today delivered remarks at the World Trade Organization Technical Barriers to Trade Symposium on how to use multilateral cooperation to overcome regulatory bottleneck.
Ambassador Pagán’s remarks as prepared for delivery are below:
Good morning! I’m pleased to be participating in this panel, with Ambassador Tan, Ms. Rute, and Deputy Director General Paugam. Thank you for the opportunity to engage on this important topic.
The United States is an active participant in the TBT Committee. We consider it to be one of the best-functioning committees of the WTO. From October 2021 to September 2022, the United States and its stakeholders provided 227 comments to the almost 4,000 notifications made by WTO Members. The opportunity to engage early with other members on proposed technical regulations and conformity assessment procedures is crucial to maximizing the chances that good suggestions can be taken into account. We are excited about the new updates to the ePing Alert System. As frequent users, we rely on it to convey notifications of proposed technical regulations and conformity assessment procedures to interested stakeholders, including the U.S. Government.
The TBT Agreement seeks to ensure that technical regulations and conformity assessment procedures do not create unnecessary obstacles to international trade; recognizing that many measures may, in fact, be necessary to ensure the quality of products, to protect human, animal or plant life or health, to protect the environment, or to prevent deceptive practices.
How do we resolve concerns about a measure that may arise out of differences in regulatory approaches? First, we try to resolve the issue at the technical level, either through the exchange of information between our designated points of communication (the WTO TBT Enquiry Points), or through exchanges between the notifier and our in-country Embassy staff. We also discuss issues bilaterally at the WTO. While these exchanges are similar to conversations the Embassy is having, the benefit is bringing Geneva staff in to broaden the knowledge of in-country representatives’ understanding of the TBT Agreement. If those communications are not successful, and we believe other Members may have similar concerns, we may raise the issue “on the floor” of the WTO TBT Committee. This allows other Members to better understand the level or magnitude of concern and share concerns among Members. And, it is most helpful when our conversations involve regulatory experts.
The United States uses a variety of tools to address regulatory divergences. We cooperate on standards, for example in international organizations such as Codex Alimentarius or the United Nations Economic Committee for Europe Working Party 29 (UNECE WP.29). We do mutual recognition arrangements, like the International Laboratory Accreditation Cooperation, or bilateral Mutual Recognition Agreements (MRAs). For example, in the case of certain medicines, we have negotiated MRAs with select foreign counterparts that allow our regulators and the regulators in our partner countries to mutually recognize our respective inspection documents for pharmaceutical manufacturing facilities, where our regulators are confident that the facilities produce safe and effective medicines. By reducing duplicative efforts among trusted regulatory authorities, the United States is streamlining the movement of pharmaceutical goods and creating a stronger, more reliable supply chain that minimizes drug shortages.
We have also included sectoral agreements in our Free Trade Agreements, such as the sectoral agreements on medical devices and pharmaceuticals in the U.S., Mexico, and Canada Agreement.
So, how do the activities of the WTO TBT Committee assist members to reduce trade frictions? The United States sees great benefit in the thematic discussions held informally on the margins of the TBT Committee. Whether it’s describing regulatory cooperation in the medical devices sector, engaging with a partner like Brazil to organize the annual thematic discussion on Good Regulatory Practices, or partnering with Canada to assemble an upcoming day-long dialogue on plastics regulation and climate change, these discussions and their emphasis on finding commonality and transparency in our regulatory systems are useful in providing early and thoughtful discussion on Members practices and experiences. These discussions help us to better expand upon our ability to assist manufacturers, farmers and ranchers to provide their products to other markets. The current focus on understanding other Members’ efforts to regulate to protect the environment is of particular interest to this Administration, and we look forward to the upcoming dialogue in the Committee in 2023.
We have used the WTO TBT Committee to effectively communicate with trading partners during the pandemic. For example, we notified a conformity assessment procedure on particulate-filtering respirator masks by our Centers for Disease Control and Prevention (CDC) to ensure all our trading partners were fully informed.
So, what more can WTO members do to counter disruptions in the supply chain that are linked to standards-related measures? Clear, consistent, and early communication on upcoming measures and taking comments of interested stakeholders into account is the best way to reduce technical barriers to trade.
We also believe that consistent and substantive contributions to the development, and use of, international standards also contribute to the reduction of technical barriers to trade. The United States is actively working on fortifying our efforts to engage on international standards and collaborate with trading partners on critical and emerging technologies, including artificial intelligence, automated driving systems, biotechnology, quantum computing, and information and communication technologies. For example, the U.S. FDA is engaged in a rulemaking on incorporating the ISO 13485 international standard into its medical device regulations.
We also work closely with the U.S. national standards body and U.S. signatory to the TBT Agreement Code of Good Practice, the American National Standards Institute (ANSI). ANSI holds and participates in regional meetings of the Americas and Asia Pacific and has a bilateral dialogue with other national standards bodies, like the Standards Administration of China, DIN in Germany, and KATS in Korea.
In addition, countries must take care not to regulate emerging technologies prematurely, which could stifle technological innovation. We urge countries to look to international standards in these areas, and where none exist, to work together in international fora to develop appropriate standards based on scientific evidence, transparency, and consensus. A great example of this is electric vehicles. In 2020, key global stakeholders came together under the auspices of UNECE WP.29 to adopt a global technical regulation for electric vehicle safety. Known as U.N. Global Technical Regulation No. 20, it addresses major concerns associated with the safety performance of electric vehicles during normal operations and sets a high standard for driver and occupant protection.
The United States also uses a variety of opportunities to provide technical assistance, such as USAID’s Standards Alliance COVID-19 Medical Device Regulatory Convergence Project (MDRC), which is conveying assistance to 10 partner countries across Latin America, Africa, and Southeast Asia to increase the transparency and predictability of regulatory systems for medical devices by providing technical assistance on good regulatory practices. The Standards Alliance has also focused programs on Africa. For example, we supported Mozambique in the finalization of its National Quality Policy. This included providing a series of technical trainings with public and private sector stakeholders from Mozambique to build awareness for the benefits of a well-developed quality system based on the principles of the TBT Agreement. To assist in the implementation of this policy, we also developed a National Quality Infrastructure handbook with Mozambique’s national standards body to assist in the understanding and implementation of the TBT Agreement.
I’d like to end by underscoring that we see great value in thematic discussions in the WTO TBT Committee such as those today on cooperative efforts in medical, automotive, and information technologies, which are critically important to global trade.
Thank you for the opportunity to present on our experiences and perspectives.