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An arm of the United Nations is working to develop global consensus on how to reduce the rapid increase in plastic pollution. The United Nations Environment Assembly (UNEA), which is the supreme governing body of the United Nations Environment Program, issued Resolution 5/14 on March 2, 2022. It requested that an intergovernmental negotiating committee (INC) be set up to develop an international legally binding instrument on plastic pollution, including in the marine environment, based on a comprehensive approach that addresses the full life cycle of plastic.
The FDA is an active participant in the U.S. government’s interagency efforts related to the negotiation, with the FDA’s Office of Global Policy and Strategy (OGPS) as the agency lead, facilitating expert perspectives from across the agency’s product centers and representing the FDA at interagency and multilateral INC meetings.
Tasked with monitoring this work on a day-to-day basis for OGPS is Matt Scherer, an international policy analyst in the Office of Trade and Global Partnerships. We had a chance to talk about the process with Scherer, and we capture his insights below.
To start out, what precipitated the March 2022 resolution? Could you give us some idea of the problem the resolution is trying to address?
Plastic products have become ubiquitous in our lives – they’re versatile, durable, lightweight, and relatively inexpensive. The global annual production of plastic products has more than doubled over the last 20 years — however, waste management capacity has not kept up. As a result, plastic waste has also doubled. According to OECD [Organisation for Economic Co-operation and Development], 23% of plastic waste was improperly disposed of, burned, or leaked into the environment. Given current trends, it’s predicted that leakage of plastic into the environment will again double by 2060 to 49 million tons per year. This waste finds itself on land, sea, and waterways, and does not know national boundaries, hence the need for a global effort.
What has happened since that March 2022 resolution was adopted?
The resolution provided for the establishment of this intergovernmental negotiating committee, or the INC. So far, there have been two INC meetings, the most recent one was in Paris in May of this year.
These have been opportunities for the parties to the United Nations to get together and start to air their initial views on what the instrument should include. The United States seeks to negotiate an ambitious instrument containing both binding and voluntary provisions that are sufficiently flexible to maximize global participation.
And so, there's been a lot of global dialogue through the INC process, but then in preparation for this dialogue, there's a lot of work happening within the U.S. government to ensure that the appropriate parts of the interagency are engaged and that we develop a position in advance of any more formal, substantive negotiations. That has been a really involved process.
 When the average person thinks about ending plastic pollution, putting that empty bottle in a recycle bin is probably all that comes to mind. But the UN has put forth a broad list of 12 possible core obligations that reach deep into all corners of the total life cycle of plastic. Can you expand on this wider view of the plastic pollution problem and how the need for making such critical changes has opened your eyes or been received by governments?
I was part of that “average” group as well, and this project has certainly opened my eyes to the complexities of the problem that covers the entire supply chain for plastic, from production to waste management.
Not only is the INC looking at the downstream measures we’re all familiar with such as improving circularity (reduce, reuse, repair, recycle) and better waste management, but the INC is also considering measures to reduce the production and demand for primary plastic polymers and to control the use of certain substances that have potential adverse health effects or impede circularity of plastic products. There is also a concern about microplastics — very small pieces of plastic that are either intentionally added to some products or that are the result of the degradation of larger pieces of plastic.
There is a desire within the INC to pull all of these levers in the instrument — production, demand, circularity, and waste management — and it will need to be done in a manner that is sensitive to the principles of environmental justice.
Global negotiations are equally complex. There are 193 countries participating in this process — and each has its own experience with plastic pollution and its own relationship with plastic products and producers. You can imagine that a smaller island nation with a tourism-based economy that has plastic debris washing up on its beaches would view the problem differently than an industrial nation whose economy is dependent on the petrochemical industry.
So, it's really quite challenging. We are dealing with a diversity of different perspectives, as well as different governments and legal systems across the world. It's a lot to work through.
What is the FDA’s role in these discussions?
The agency has been engaged in these efforts since the INC was established as there is notable overlap between the commodities FDA regulates and the UNEA resolution. Many FDA-regulated products directly incorporate or are packaged in plastic, which can be integral to their safety and efficacy. There are obvious implications for food contact materials, but plastics are used in medical products, as well. For example, many medical devices include plastic components, and plastic is a frequently used material in pharmaceutical container closure systems, which are important for ensuring product stability and quality. There's also plastic used in many drug and vaccine delivery devices.
The point of all this is that in most, if not all, FDA-regulated commodities, plastic can be important to manage or ensure safety and efficacy. If the UNEA instrument were written in such a way that didn’t account for these important uses of plastic, it could result in unintended consequences such as product shortages. It is important that any agreement focusing on plastic pollution avoid compromising a regulator’s ability to ensure the safety and effectiveness of the products it regulates.
If plastic is so endemic to medical products and food safety, certainly our regulatory counterparts are grappling with some of the same issues?
Yes, I would expect that our regulatory counterparts have been or will be grappling with the same issues. I met with many individuals and organizations at INC-2 in Paris, in both formal and informal settings. Thus far, the delegates I have met were mainly from their countries’ Environmental Ministries, but I am eager to hear how our international health regulatory counterparts are dealing with these same issues. Perhaps there is an opportunity to learn from each other. Working with the FDA’s product centers on this over the last year has given me a keen appreciation for the many nuances of the issue and why regulator participation early in the process is important.
One of the common objectives in many multilateral environmental agreements is to protect human health and this one likely will as well. We embrace that goal and want to ensure it can be achieved without affecting the availability of safe and effective medical products and food.
Is the United States taking into account the views of non-governmental stakeholders?
That is another important part of the process. The State Department (State) is the lead negotiator for the United States. Before each INC, it has been organizing listening sessions with environmental NGOs [nongovernmental organizations] and industry. State also leads engagement with local and state governments, tribes and, of course, the Hill. One task I'm taking on is to ensure that our regulated industry is aware of and engaged in these sessions. I've attended several listening sessions thus far and met directly with stakeholders at INC-2 in Paris and expect to do so again at INC-3 in Nairobi. There is a lot of passion in the NGO community, and they are pushing all members to maximize the ambition of the instrument. Likewise, some aspects of industry are very much engaged as they are likely to be affected by the final provisions of an agreement. Rich stakeholder engagement, including by FDA-regulated entities, is good for the process.
You've attended a couple of meetings already, and you're attending a third meeting in Nairobi, Kenya, in November. So how long can we expect this whole process to take, if you say we're early on?
Well, we're early on in terms of our progress. We're not necessarily early on in the process.
There will be five INC meetings total, and we are coming upon INC-3. The fifth and final INC meeting is planned for late fall 2024 in South Korea. And, at that time, the goal is to have agreed upon text that can then be taken back to each member state’s leadership, to go through their own processes to ratify or sign. So, there is quite a bit of work that has to be done and not a lot of time to do it.
So far, the bulk of the international work has been taking place at these INC meetings, but I think it's clear that starting after INC3, we're going to have intersessional work to achieve the ultimate goal of developing an international instrument to stop plastic pollution.
There is a lot of difficult work ahead, but I am optimistic. There are so many dedicated people across the globe working toward the final objective of ending plastic pollution. I am glad to be one of them.
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