   
  
G/TBT/GEN/374  
 
13 May 2024  
(24-3720) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
  
AGENDA ITEM 5: TECHNICAL COOPERATION ACTIVITIES  
UPDATE BY ANSI ON ACTIVITIES RELATED TO THE WORK OF THE TBT COMMITTEE  
STANDARDS ALLIANCE BRIEF COVERING PERIOD: NOVEMBER 202 3 TO MARCH  2024 
This document contains information provided by the United States  at the TBT Committee meeting 
of 13-15 March 2024 under Agenda Item 5.  
 
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1.  The United States takes our commitment to capacity building seriously. As such, we would call 
member attention to our continued efforts to support the understanding and implementation of the 
TBT Agreement through the Standards Alliance program. The Standards Alliance is a public -private 
partnership between the U.S. Agency for International Development (US AID) and the American 
National Standards Institute (ANSI), which coordinates with developing and least developed 
countries to identify and prioritize areas for technical assistance.  
2.  The Standards Alliance was established in 2013 with a focus on the impleme ntation of the TBT 
Agreement in 10 country/regions and was expanded in 2016 to include West and Southern Africa. 
The first phase of the Standards Alliance came to a close in September 2021; however, the program 
was renewed for a second phase in 2019. Phase  2 of the Standards Alliance remains active and 
builds upon the successes and measured impacts of the first phase to provide targeted technical 
assistance to developing countries. The second phase focuses on support related to the development 
and implement ation of National Quality Infrastructure and Good Regulatory Practices that are rooted 
in the principles of the TBT Agreement. In late 2022, the Standards Alliance Phase 2 (SA2) was 
extended beyond its original 5 -year term and will now conduct activities t hrough mid -2026. The SA2 
will focus the new activities that will be developed from 2024 to 2026 in the critical minerals, 
sustainability, agribusiness, automotive, digital infrastructure, water and sanitation, and medical 
devices sectors.  
3.  Standards Allianc e activities between November 2023 to March 2024 have included the following 
highlights:  
• In response to the COVID -19 pandemic, the Standards Alliance continues to support technical 
capacity in the medical devices sector, while also helping participating na tions identify 
technical and regulatory barriers to trade. This activity, the "COVID -19 Medical Device 
Regulatory Convergence (MDRC) project", builds the capacity of partner countries to 
effectively implement standards and conformity assessment procedures related to medical 
devices; remove technical barriers to trade for medical devices; increase patients' access to 
needed high -quality Personal Protective Equipment (PPE) and other medical technologies in 
response to COVID -19 and future global health crises;  and foster private sector engagement 
in the (medtech) regulatory space. The project countries of focus include Brazil, Colombia, 
Mexico, Peru, Indonesia, Vietnam, Ghana, Kenya and South Africa.  
The MDRC  substantively concluded its technical assistance with a set of successful training 
workshops in Kenya and South Africa. The first activity, which took place on  in Nairobi on 
November 6 -10 and brought together approximately 150 attendees from 10 African co untries, 
fostered information exchange and capacity building between the AMDF, its member National 
Regulatory Authorities (NRAs), and relevant international NRAs and industry covering the core 
international references for medical device regulatory framewor ks. Members of the U.S. FDA G/TBT/GEN/374  
 
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  attended in person to train attendees from Kenya, South Africa, and Ghana (covered by MDRC) 
as well as representatives from Botswana, Burkina Faso, Central African Republic, Ethiopia, 
Gabon, Nigeria, Tanzania, and Zambia (covere d by AMDF), as well as private sector attendees 
from surrounding countries and the Middle East. The second leg took place in Pretoria and 
included tailored trainings for the South African NRA, SAPHRA.  
The program had a final training for the MDRC as part o f SA2, but team remains available as 
a legacy of the project to help assist with questions and challenges as part of their journey in 
compliance with international law and best practices. Great strides were made within the 
regulatory side as well as the st andards side, with space being intentionally created for 
bilateral meetings between ANSI, KEBS, and ARSO, as well as government -to-government 
meetings occurring in a parallel track to conformity assessment trainings on the IEC EE 
scheme.  It is worth noting , that as a result of this technical assistance project Kenya was able 
to apply, and later accepted, as an affiliate member of the International Medical Devices 
Regulators Forum which plays a preeminent role on regulatory and standards matters for 
medical devices promoting regulatory convergence and efficient and effective regulatory 
models . 
• Increase the Flow of WASH Services  
Access to improved drinking water and sanitation is one of the most fundamental issues facing 
the global community. The challenges su rrounding improving access to water and sanitation 
services are systemic and related to poor governance, inadequate infrastructure and supply 
chains, poor system maintenance, skilled worker shortages, and transforming cultural or social 
norms related to sa nitation. The International Association of Plumbing & Mechanical Officials 
(IAPMO) will address these issues to pave the way for increased trade and exports of related 
technologies and services. In Indonesia, IAPMO is assisting the National Standardization  
Agency of Indonesia (BSN) to develop and adopt a new national standard related to water 
faucets and to provide technical assistance to relevant ministries on its adoption and 
enforcement. As the final endpoint of water delivery systems, this new standard will ensure 
that these products meet basic levels of safety and efficiency. Standardization and 
enforcement in this area is critical to protecting the performance and health of drinking water 
systems for Indonesian's citizens. IAPMO helped to coordinate BS N Technical Committee 
77-02 meetings to support national adoption of this new standard, and in early 2023 the BSN 
formally adopted the new national Indonesian standard. Work is continuing in 2023 and 2024 
to promote implementation of the new standard by wo rking with government ministries and 
private sector on appropriate certification schemes and regulatory options.  
• Plumbing The Legal Depths — Creating a Pipeline Between Legal Enabling and NQI  
There is a need to accelerate citizen's access to water and sani tation services and facilitate 
the improvement of National Quality Infrastructure (NQI) as related to the water, sanitation, 
and hygiene (WASH) sector. Laws, regulations, policies, and standards create the foundation 
for achieving universal access to safel y managed water and sanitation services and for a 
vibrant, open market in WASH products. By assessing existing laws, regulations, policies, and 
standards, we can understand how the current legal environment creates or eliminates trade 
barriers to safe, hig h quality WASH products and creates the commitment necessary to 
generate more widespread access to water and sanitation. This project coordinated by the 
Center for Water Security Cooperation (CWSC) performs diagnostics of the existing legal, 
policy and i nstitutional frameworks governing NQI related to the WASH sector in Ghana, 
Uganda, and Zambia. These diagnostics assess the enabling environment to increase access 
to drinking water and sanitation, support the adoption and application of international WASH  
standards, and enable the removal of WASH NQI barriers to trade in WASH products.  
To mark the launch of the report, "Plumbing The Depths: An Analysis of NQI WASH in Ghana, 
Uganda, and Zambia ," the Standards Alliance, The Center for Water Security and Cooperation 
(CWSC), and the International Association of Plumbing & Mechanical Officials (IAPMO) hosted 
an educational webinar for representatives from Ghana, Uganda, and Zambia who work in 
Water, Sanitation, and Hygiene (WASH) across private, government, academic, and non -profit 
organizations.  
"Plumbing the Depths " analyzes and evaluates drinking water and sanitation laws to determine 
whether they are sufficient to enable an effective national quality infrastructure for WASH. 
Ultimately, the research revealed several gaps within WASH  laws and standards that suggest 
opportunities for improvement in the three countries. These gaps present key opportunities G/TBT/GEN/374  
 
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  for strengthening the sector, and the report offers suggestions for how WASH laws can be 
enhanced.  
• Support for critical minerals sta ndardization coordination  
This activity is new since the program extension was completed in 2022. In March 2023, 
ISO/TMB and the ISO Council approved and accepted the report of the Strategic Advisory 
Group (SAG) on Critical Minerals. The group's mandate wa s agreed as follows: Undertake an 
analysis of existing and potential standardization work in the area of critical minerals from the 
point of initial extraction (mining and production of raw materials), and processing steps 
through to pre -cursor materials; and make recommendations to the TMB in this regard.  
The SA2 will support the work of the SAG on Critical Minerals and ISO TC 345 through activities 
such as:  
• Conducting awareness building to form a U.S. mirror committee (TAG).  
• With the input of the VTAG, su pport activities recommended by the SAG as next steps 
including dialogue with other ISO members in support of any new standards proposed 
or developed; training or awareness -building activities that would enable developing 
countries to participate in standa rds development for critical minerals.  
• Promote international standards for Management Systems for UN Sustainable development 
goals 
The SA2 is supporting the work of ISO PC 343 through activities such as:  
• Conducting stakeholder outreach to support the forma tion of a U.S. TAG to ISO PC 343, 
and forming and administering the U.S. TAG to ISO PC 343 to enable U.S. contributions 
toward its international outputs.  
• Coordinating within the U.S. stakeholder group including U.S. government agencies and 
private sector t o align future work within ISO with U.S. policies and positions.  
• Management Systems for Sustainable Cities, Cote d'Ivoire (CDI)  
ANSI is implementing this project which aims to:  
• Provide guidance and policy models to the govt of CDI for developing a national  policy 
on sustainably decentralizing communities in line with international standards and best 
practices.  
• Evaluate the progress of two pilot communities trained in SA Phase 1 on implementing 
ISO 37101 and establish a roadmap for certifying these communiti es to ISO 37120.  
• Activities include:  
• Review of existing policies on decentralization and CDI's regulatory process  
• Virtual and in -person roundtable meetings and trainings to share information and train 
pilot communities on relevant ISO standards.  
• Data gathering to inform policy guidance and roadmap to certification  
• Improving Point -of-Care Ultrasound Access, Kenya  
ANSI has started implementation for this activity, which will run until 2026 in with The Inteleos 
Foundation . The project underpins Kenya's go als as related to maternal and newborn health , 
aiming at:  
• Expand ultrasound education and training programs, with a focus on ensuring 
proficiency among midwives, nurses, and clinical officers.  
• Strengthening policy and regulatory frameworks to support the  use of ultrasound in 
maternal care.  
• Enhancing socioeconomic impact by creating entrepreneurial job opportunities for 
individuals in nursing and midwifery.  
• Activities include:  
• Capacity -building funding to continue to create the policy and regulatory framew ork for 
sustainable task expansion and Universal Health Care.  
• Training and certification in partnership with local trainers, device manufacturers and 
clinicians.  
4.  More information regarding the overall Standards Alliance Phase 2 (2019 -2026) can be found 
here. 
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