- U.S. Brazil Trade Protocol: The Forum recommends that both governments accelerate their cooperation to implement and recognize implementation of the Protocol to the Agreement on Trade and Economic Cooperation between the Government of the United States of America and the Government of the Federative Republic of Brazil Relating to Trade Rules and Transparency – including its annexes on Trade Facilitation, Good Regulatory Practices and Anti-Corruption.
Progress & Next Steps
- ATEC Protocol: The U.S.-Brazil Protocol on Trade Rules and Transparency entered into force in 2022. The Protocol includes three annexes with bilateral commitments on Customs Administration and Trade Facilitation, Good Regulatory Practices, and Anti-Corruption. Transition periods affecting a few provisions will be complete in 2024, allowing full implementation of the Protocol.
Supply Chain Resiliency
- Work towards formalizing cooperation to increase supply chain agility and resiliency through mutual market access, trade facilitation and regulatory harmonization to remove unnecessary trade, customs and other barriers, or restrictions to build up trade and investment in these key areas between both countries;
- Prioritize work on critical elements of supply chains, including COVID response materials, key raw materials and inputs and others that encourage diversification of supply chains and support efforts to increase production of renewable energy, battery technology and others. With key identified priority materials, both governments should identify and address any trade barriers, restrictions, or investment impediments to more resilient supply chain partnerships; and
- Convene stakeholder discussions with industry to develop collaborative approaches to identify critical energy technology supply chains for ensuring security of supply in the energy transition and prioritize development of resilient value chains critical to increasing production of key materials such as solar panels, EV batteries and semiconductors in the Western Hemisphere.
Progress & Next Steps
- Increasing supply chain agility: The ITA-led U.S.-Brazil Commercial Dialogue leverages its working groups to support both countries’ efforts to enhance resilient supply chains by working to eliminate or reduce bottlenecks within supply chains. The Dialogue works to facilitate efficient customs practices, increase predictability, and support regulatory cooperation and adoption of good regulatory practices contributes to resilient supply chains across industries.
- COVID response materials/healthcare supply chains: The U.S. Food & Drug Administration is committed to advancing regulatory harmonization and convergence. The U.S. will continue prioritizing work on critical elements of supply chains, including pandemic-related response materials.
- Renewable energy supply chains:
- U.S.-Brazil Clean Energy Industry Dialogue: On August 18, 2022, the U.S. Departments of Energy and Commerce, in coordination with Brazil’s Ministries of Mines and Energy and Foreign Affairs, inaugurated the U.S.-Brazil Clean Energy Industry Dialogue (CEID) to promote bilateral clean energy trade, investment, partnership, and deployment while advancing climate ambition. The CEID established five bilateral public-private working groups focusing on: clean hydrogen, offshore wind, grid modernization and storage, sustainable fuels, and carbon and methane management.
- Carbon and Methane Management Action Committee: On October 10, 2023, the CEID launched the Carbon and Methane Management Action Committee focused on carbon capture utilization and storage hubs. The two governments presented on respective plans for carbon capture utilization and storage (CCUS), followed by a private sector-led discussion on projects, barriers, and opportunities in CCUS in the United States and Brazil.
- Critical Mineral supply chains: The U.S.-Brazil Critical Mineral Working Group (CMWG) held its first meeting under the Lula administration on July 19, 2023. The CMWG aims to bolster mineral production and processing by sharing expertise in exploration and sustainable practices. The virtual session centered on enhancing critical mineral value chains and establishing sustainable mineral strategies. State/ENR DAS Anna Shpitsberg and Brazil’s Ministry of Mines and Energy (MME) Secretary of Geology, Mining and Mineral Processing Vitor Saback, agreed that the CMWG should meet more frequently to dive deeper into expanding critical minerals supply chains.
- Conclude the mutual recognition arrangement (MRA) of the Customs Trade Partnership Against Terrorism (CTPAT)/Authorized Economic Operator (AEO) between the United States and Brazil, and develop workshops aligned with industry to implement key components of the joint workplan and increase efficiency, such as in adoption of digital documentation;
- Coordinate an action plan to pilot technology investment projects to further streamline, reduce costs and increase transparency across the supply chain; and
- Establish SMART metrics to achieve best in the world U.S. and Brazilian customs clearance times, starting with a pilot project in a key sector such as medical technology.
Progress & Next Steps
- ATEC Protocol: Both governments have made great strides in the area of trade facilitation. The ATEC Protocol Customs Administration and Trade Facilitation Annex expands on commitments made in the WTO Trade Facilitation Agreement and includes commitments for online publication of customs and other border information; a single window for import, export and transit; electronic systems for traders; greater acceptance of electronic documents; mechanisms to help ensure consistent customs treatment from port to port; and expanded customs cooperation, including on trade enforcement.
- Mutual Recognition Arrangement: On September 16, 2022, the United States and Brazil signed the Authorized Economic Operator (AEO) Mutual Recognition Arrangement (MRA). The AEO MRA is a result of a multi-year initiative led by the U.S. Customs and Border Protection and Receita Federal with support from the U.S.-Brazil Commercial Dialogue. The AEO is a milestone in the shared cooperation on customs and trade facilitation issues. Execution of the AEO MRA will facilitate the movement of goods between trusted traders in the United States and Brazil.
- Trade Facilitation: Through the Commercial Dialogue, the United States and Brazil have an active agenda on trade facilitation issues. In 2022 and 2023, the Trade Facilitation working group of the Commercial Dialogue held information exchanges related to the Brazil Global Trade Hub, the U.S. Trade Promotion Coordinating Committee. They also set forth an ambitious work plan focused on supporting SMEs and identifying best practices in processing small packages.
Global Regulatory Practices and Sectoral Regulatory Convergence
- Implement Annex II of the U.S. – Brazil Trade Protocol on Good Regulatory Practices (GRP).
- Pilot sectoral discussions that will demonstrate more effective governance and commitment to sound science, risk-based procedures.
- Ensure strong stakeholder engagement in developing these pilot workshop discussions.
Progress & Next Steps
- Implementation of GRP Annex of ATEC Protocol: The U.S.-Brazil Protocol on Trade Rules and Transparency includes a state-of-the-art Annex on GRPs that will advance transparency and public participation in Brazil’s rule making process.
- Publication of Decree 11,243: On October 21, 2022, the Government of Brazil published Decree 11,243, which formally implements the GRP Annex to the ATEC Protocol.
Secretariat for Competitiveness and Regulatory Policy: In early 2023, the Lula Administration created the Secretariat for Competitiveness and Regulatory Policy that will work to implement GRP best practices.
- Fostering GRP Principles: Through the Commercial Dialogue, the U.S. Department of Commerce continues to focus on promoting key GRP principles, including the use of notice and comment, regulatory impact analysis, and a risk-based approach to decision making. The Commercial Dialogue organized discussions on interagency coordination, regulatory impact analysis, and regulatory review. These activities have supported important regulatory reforms in Brazil, including the ongoing implementation of Brazil’s Regulatory Agencies Law, Economic Freedom Law, and associated implementing decrees.
- Regional GRP Efforts: At the Summit of the Americas in 2022, Brazil endorsed a joint declaration on Good Regulatory Practices (GRP) alongside Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Haiti, Panama, Paraguay, and Uruguay. The declaration identifies actions and practices the aforementioned countries intend to take to instill confidence, accountability, and predictability in regulatory processes. In July 2023, Brazil presented on its GRP implementation work at a status update meeting with the countries that joined the 2022 Declaration, as well as Peru and the Inter-American Development Bank.
- Standards and Conformity Assessment: Commerce, through the Commercial Dialogue, is working to facilitate bilateral trade by improving the mutual understanding of each country’s regulatory system while fostering opportunities for regulators to share experiences and best practices. The Commercial Dialogue held numerous webinars focused on trade in the cybersecurity sector, trade-related aspects of technical regulations, standards and conformity assessment procedures regarding cybersecurity. On February 25, 2022, the National Institute of Metrology, Standardization and Industrial Quality (INMETRO) published its new regulatory framework via Ordinance 30. The new framework incorporates many of the concepts discussed over the many years of bilateral engagement on GRP, standards, and conformity assessment and addresses many of the concerns raised by industry in both countries. The National Institute of Standards and Technology (NIST) frequently consulted with INMETRO and shared U.S. practices during this time. The United States government submitted formal comments to INMETRO’s Technical Barriers to Trade (TBT) notification as did numerous private-sector stakeholders.
- Standards for Critical and Emerging Technologies: On August 22, 2023, NIST and ITA presented on the new U.S. Standards Strategy for Critical and Emerging Technologies (USSCET) to a group of 20 Brazilian government officials. NIST will further engage with INMETRO to identify common interests as the U.S. implements its strategy.
- Medical Devices & Products: The U.S. Food & Drug Administration (FDA) and the Brazilian Health Regulatory Agency (ANVISA) renewed a Statement of Cooperation and are engaged on Project Orbis, an effort to promote the authorization of oncological products. Through the International Medical Devices Regulators Forum (IMDRF), FDA and ANVISA are working with other regulatory partners to develop and implement harmonized best practices that meaningfully inform one another’s approach to regulatory decision-making. For example, the IMDRF Table of Contents documents establish a comprehensive harmonized structure for pre-market medical device submissions.
- Medical Device Regulatory Convergence:
- To strengthen medical device sector-specific regulatory convergence and cross-sectoral GRPs, the U.S. Agency for International Development (USAID) is funding the Medical Device Regulatory Convergence (MDRC) project under the Standards Alliance, a public-private partnership between USAID and the American National Standards Institute (ANSI), and the Advanced Medical Technology Association (AdvaMed). Brazil is among the participating countries, working through the Brazilian Health Regulatory Agency (ANVISA). The multi-year project establishes international benchmarks for medical device regulatory convergence and assist participating countries in implementing structural policy changes to better align medical device regulatory frameworks, technical regulations, standards, and conformity assessment procedures. This is expected to result in increased regulatory efficiency, improved patient access to innovative healthcare technologies, and lowered barriers to trade. Under this project, ANVISA and FDA collaborated on webinars on Software as a Medical Device, Unique Device Identification, Standards and Conformity Assessment.
- In August 2022, ANVISA published RDC 741/2022 to describe a new process by which it leverages registrations from foreign regulatory agencies. In September 2023, it provided additional public information about this new process, indicating that some of the pre-market decisions made by the FDA would be eligible.
- Energy Sector Regulatory Efforts: Under the U.S.-Brazil Energy Forum (USBEF), the U.S. Department of Energy (DOE) hosted the first of a series of technical workshops, focusing on the regulatory perspectives of carbon capture utilization and storage in October 2023.
The U.S. and Brazilian governments should work with industry to develop clear priority opportunities to pilot environmental value-chain solutions including:
- Waste management approaches to create capacity for recycling of critical materials for advanced manufacturing and supply chain resilience;
- Aligned with infrastructure recommendations, develop priorities, and promote standards for more environmentally friendly construction technologies;
- Work constructively on infrastructure prioritization to build more integrated regional grids leveraging low-carbon energy solutions, such as solar, wind, energy storage and natural gas; to promote more sustainable and resilient manufacturing; and
- Review the current process of land acquisition in Brazil to promote effective land ownership, fostering more green and sustainable investments.
- Support the development and improvement of green economy, which will generate environmental and climate benefits by supporting biodiversity protection, increase of native forests regeneration projects and standing forest compensation mechanisms, as also fostering investments in agroforestry systems and R&D for the sustainable use of biodiversity.
Progress & Next Steps
- Climate Change Working Group: Presidents Lula and Biden announced the resumption of the United States-Brazil Climate Change Working Group (CCWG) on February 10, 2023. Brazil and the United States are finalizing a work plan under the CCWG that will include a focus on restoration of native forests, payments for environmental services, agroforestry, and sustainable use of natural resources.
- Green Tech Mission: The U.S. government supported a September 2023 Green Tech Mission with over 40 U.S. and Brazilian companies. This Mission helped identify investment opportunities in agriculture, forests, bioeconomy, clean energy, and adaptation that are consistent with Brazilian and U.S. climate priorities. It also highlighted U.S. solutions and connected U.S. and Brazilian industry in the green economy and priority sectors recommended by the Forum.
- Energy Transmission and Storage: On October 26, 2023, The U.S. Department of Energy’s National Renewable Energy Laboratory hosted the first of a two-part webinar series on technologies and best practices to optimize the use of transmission and energy storage assets through smart technologies with the goal of optimizing grid integration and/or decreasing demand.
- Remanufactured Goods and Sustainability: Through the U.S.-Brazil Commercial Dialogue, we are actively pursuing Forum recommendations on circular economy. In 2022, the U.S. Department of Commerce and the Brazilian Ministry of Economy hosted a two-part webinar series on trade in remanufactured goods featuring speakers from the U.S. and Brazilian governments, private sector, and academia. Following the November 2023 Plenary, Commerce and Brazil’s Ministry of Development, Industry, Trade and Services are developing new work plans on sustainability related to climate and trade that will focus on circular economy.
- Environmental Protection Regulations & Trainings: Since November 2019, the U.S. Environmental Protection Agency (EPA), in collaboration with the U.S. Geological Survey (USGS), has been providing a range of water and sanitation training to the Brazilian National Water and Sanitation Agency (ANA). In 2022, EPA and USGS completed a 20-part webinar series, covering topics ranging from enforcement of water regulation to best practices for sharing information with the general public to pollutant measurement methodologies. EPA has also hosted three webinars for the Brazilian Ministry of Environment (MMA) and the U.S. and Brazilian private sectors to share EPA’s regulatory approach to marine litter, water and sanitation infrastructure finance, and land contamination.
- Collaboration on Climate Adaptation: EPA and the São Paulo State Environmental Regulatory Agency (CETESB) continue to collaborate in the transfer of EPA’s Adaptation Resource Center (ARC-X) tool to São Paulo State. EPA is working with CETESB on finding Brazilian partners to add content to its ARC-X platform.
- Supporting the Adoption of Water Standards: USAID’s Standards Alliance funded the project “Community Water Systems–Standards for Safety and Risk Management”, which supported building consensus among public agencies, private sector stakeholders, academic, and non-governmental stakeholders for standards that validate the safety and/or efficacy of materials, chemicals, and water treatment devices that come into contact with municipal, community, and building/home drinking water systems in Brazil.
- Water & Wastewater, Waste Management, Recycling: Commerce has been working with other U.S. government agencies in Brazil to track changes to laws, business opportunities, and promote U.S.-made technologies to the water, wastewater, and solid waste industry in Brazil, including with the Brazilian government. Most recently, in early May 2023, FCS Brazil led a delegation of government and private sector representatives, including a Brazilian federal senator and several state-level secretaries, to the trade show WasteExpo 2023 in New Orleans, LA.
- Sustainability, Biodiversity, and Forests: In November 2022, Foreign Commercial Service (FCS) Brazil organized a workshop between the U.S. National Oceanic and Atmospheric Administration (NOAA) and the state of São Paulo to discuss the implementation of the Marine Biodiversity Observation Network (MBON) at the coast of São Paulo featuring presentations about U.S.-made technologies used in marine biodiversity monitoring. In 2024, FCS Brazil plans to organize an event in Manaus, Amazonas, to connect Brazilian and U.S. stakeholders from the private sector, governments, civil society, local communities, and international organizations around sustainability and economic development in the Brazilian Amazon region and (potentially) other Brazilian biomes.
- Sustainable Investments: Investments made by Impact Earth’s Amazon Biodiversity Fund (ABF), an innovative fund co-created by USAID and backed by a DFC loan guarantee, yielded strong results including improved biophysical conditions of 132 hectares, the creation of 4 new enterprises, and the creation of 29 new products of Amazonian origin. The ABF is about to conclude its fundraising with additional investments of about $28 million from the Soros Economic Development Fund (SEDF) and the Brazilian Development Bank (BNDES).
- Private sector partnerships to support a Forest-Based Economy in the Brazilian Amazon: Through co-creation and co-funding between USAID and private sector entities, the USAID-born Partnership Platform for the Amazon (PPA) extended its portfolio of Territorial Development and Impact Business Strengthening to reach new regions and value chains. Through these partnerships, in 2023 PPA’s cumulative accomplishments include improved management of over 13.4 million hectares of Protected Areas in the Amazon, providing socioeconomic benefits to 24,650 people, developing 262 biodiversity-based products, supporting 159 businesses, and mobilizing over $9 million.