EPA’s New Chemical Program Considered in GAO’s WatchBlog Report

Chemicals are the quiet background singers of modern life. They are in cleaning sprays, building materials, electronics, crop protection products, paints, packaging, medical supplies, and enough everyday items to make your kitchen cabinet look like a tiny industrial supply chain. Most people do not spend their morning coffee break thinking about premanufacture notices, toxicology models, or environmental fate reviews. Fair enough. But before a new chemical can legally move into the U.S. marketplace, the Environmental Protection Agency has an important question to answer: could this substance pose an unreasonable risk to people or the environment?

That is where EPA’s New Chemicals Program comes in. Under the Toxic Substances Control Act, commonly known as TSCA, EPA reviews new chemical substances before they are manufactured or imported for commercial use. In August 2025, the U.S. Government Accountability Office, or GAO, highlighted the program in a WatchBlog post tied to its earlier report, New Chemicals Program: EPA Needs a Systematic Process to Better Manage and Assess Performance. The title may not sound like beach reading, but the issue matters. When the program works well, safer innovation can move forward. When it gets bogged down, businesses wait, potential substitutes stall, and public confidence takes a coffee spill to the lap.

What Is EPA’s New Chemicals Program?

EPA’s New Chemicals Program is the federal review system for chemical substances that are not already on the TSCA Inventory. In plain English, if a company wants to manufacture or import a new chemical in the United States, it may need to submit a notice to EPA before doing so. The most common filing is a premanufacture notice, or PMN. Other submissions include significant new use notices, microbial commercial activity notices, low volume exemptions, low release and exposure exemptions, and test marketing exemptions.

The goal is not to make innovation walk through wet cement. The goal is to evaluate risk before a substance enters commerce. That means looking at how the chemical may be made, processed, used, released, disposed of, and encountered by workers, consumers, communities, and ecosystems. EPA scientists may consider hazard, exposure, environmental release, persistence, bioaccumulation, and available testing data. When laboratory data are limited, EPA may use predictive models and chemical analogs to estimate potential risks.

TSCA was significantly updated by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed in 2016. That reform strengthened EPA’s responsibility to make risk-based determinations before new chemicals enter the market. It also increased expectations for transparency, deadlines, and public health protection. On paper, the idea is simple: review new chemicals before they become widespread. In practice, it is a complex balancing act between scientific uncertainty, statutory timelines, business planning, and environmental safety.

Why GAO Looked at the Program

GAO reviewed EPA’s implementation of the New Chemicals Program because timeliness and management have become persistent concerns. TSCA generally gives EPA a 90-day review period for many new chemical notices, although real-world cases can extend longer for several reasons, including missing information, data concerns, risk management negotiations, or submitter delays.

GAO’s report found that EPA had historically struggled to complete determinations within the 90-day review period. In a previous 2023 assessment, GAO reported that EPA made determinations within the initial 90-day period less than 10 percent of the time for completed premanufacture reviews from 2017 through 2022. That statistic is the regulatory equivalent of a smoke alarm chirping at 3 a.m. It does not automatically mean the system is broken beyond repair, but it does mean someone needs to change the battery.

For its 2025 report, GAO interviewed representatives from 19 manufacturers that had submitted notices to EPA between October 2021 and April 2024. GAO also reviewed EPA’s management practices, planning documents, and performance approach. The agency wanted to know two big things: what manufacturers experienced during the process, and whether EPA was using strong management practices to assess and improve the program.

What GAO Found: Strengths, Delays, and Frustration

GAO’s findings were not a simple thumbs-up or thumbs-down. The report recognized that EPA performs a scientifically demanding job and that many manufacturers found some public information sources helpful. In fact, nearly all of the manufacturer representatives GAO interviewed said EPA’s public information was somewhat or very helpful. That is good news. Nobody wants a regulatory process where the instructions read like they were translated from legalese into fog.

But GAO also found major pain points. Sixteen of the 19 manufacturer representatives said they experienced review delays. Companies reported that delays harmed customer relationships, affected finances, limited market participation, and created advantages for existing chemicals over newer alternatives. That last point is especially important. If a new chemical could be safer or more effective than an older substance, delays might unintentionally keep the older option in place longer.

Manufacturers also identified transparency concerns. Some wanted clearer review requirements, better communication about where a case stood, more realistic timelines when the 90-day review window could not be met, and more detailed guidance about what information EPA needed. Others described challenges using EPA’s Central Data Exchange, known as CDX, especially when handling confidential business information claims or correcting technical errors.

The 13-Step Review Process: Thorough, but Not Tiny

GAO noted that EPA’s new chemical review process involves 13 steps. These may include pre-screening, chemistry review, environmental fate review, engineering assessment, ecological hazard review, human health hazard review, exposure assessment, risk characterization, and risk management. That is not a quick peek at a label. It is a multidisciplinary review of how a chemical might behave from production to disposal.

For example, an environmental fate review may examine how a chemical moves, transforms, or accumulates in air, water, soil, or sediment. A human health hazard review may consider whether a substance could cause cancer, reproductive harm, developmental effects, irritation, sensitization, or other health concerns. An engineering assessment may estimate releases and worker exposures during manufacturing, processing, or use. These steps are necessary because chemicals do not politely stay in one place just because a spreadsheet told them to.

The challenge is that thorough review takes time, expertise, and data. If a submission lacks important information, EPA may need to ask questions. If EPA identifies risk concerns, it may need to negotiate an order or develop a significant new use rule. If a chemical resembles a class of persistent or toxic substances, the review may become even more cautious. The WatchBlog report captures this tension well: the public wants safety, industry wants predictability, and EPA must operate within real staffing and resource limits.

EPA’s Management Challenge: Not Just Science, but Systems

GAO’s biggest criticism was not that EPA scientists were ignoring safety. It was that the New Chemicals Division did not follow most of GAO’s key management and assessment practices for federal programs. GAO said EPA had taken some initial steps, including drafting a strategic plan in August 2024 with five strategic goals. However, GAO found that the plan did not fully incorporate important practices such as involving external stakeholders and identifying the resources needed to achieve each goal.

GAO also found that EPA had not developed a systematic performance management process aligned with those key practices. In simple terms, EPA needed a clearer way to set goals, measure progress, use evidence, learn from results, and adjust course. This is not glamorous work. Nobody throws a parade for performance management. But without it, a program can end up fighting the same fires again and again while wondering why the smoke detector keeps winning.

GAO’s Recommendations to EPA

GAO made two main recommendations. First, EPA should ensure that the New Chemicals Division addresses relevant management and assessment practices as it finalizes its strategic plan. That includes involving stakeholders and identifying needed resources. Second, EPA should implement a systematic process that aligns performance management with key practices.

EPA agreed with both recommendations. The agency also noted that improving efficiency and transparency may be limited without significantly increased resources. That caveat matters. A review program cannot simply wish itself into faster timelines if it lacks enough experienced reviewers, modern tools, reliable data systems, and support staff. The best process map in the world will not carry a workload by itself; it still needs people, funding, and technology.

Recent EPA Actions and Regulatory Updates

EPA has not been standing still. In December 2024, the agency finalized amendments to the regulations governing new chemicals reviews under TSCA. The final rule was designed to improve efficiency, align regulations with the 2016 Lautenberg amendments, and clarify the level of detail submitters should provide in new chemical notices. It also specified that EPA must make one of the statutory determinations for relevant notices before a submitter may begin manufacturing or processing.

The final rule also made new PFAS and certain persistent, bioaccumulative, and toxic chemicals ineligible for low volume exemptions and low release and exposure exemptions. That change reflects a broader concern about substances that persist in the environment or build up in living organisms. For companies, the lesson is straightforward: if a chemical falls into a higher-concern category, do not expect a shortcut through the review process.

EPA has also continued to issue significant new use rules, or SNURs. These rules can require companies to notify EPA before using a chemical in a way that differs from the conditions EPA reviewed. SNURs are an important backstop. They help prevent a chemical that was approved for one limited use from quietly expanding into riskier uses without additional review.

What the Current Workload Shows

EPA’s public statistics help illustrate why the program remains under pressure. As of April 1, 2026, EPA reported 439 active PMN, SNUN, and MCAN cases in the review process. Of these, 301 were with EPA and 138 were with submitters. EPA also reported 148 active LVE, LoREX, and TME cases, with 122 at EPA and 26 with submitters.

Those numbers show that delays are not always one-sided. Some cases are waiting on EPA review, while others are waiting on submitters to provide information, sign orders, or complete steps. That distinction matters for fair analysis. A review system can slow down because an agency lacks capacity, because submissions are incomplete, because risk issues require negotiation, or because all of the above decide to meet for lunch and stay too long.

Why This Matters for Public Health

The New Chemicals Program is one of the few chances regulators have to evaluate risks before widespread exposure occurs. That is a big deal. Once a chemical is used across supply chains, removing or restricting it can become far more difficult, expensive, and politically complicated. Early review is like checking a bridge before traffic opens, not after the morning commute discovers a surprise.

Communities, workers, and consumers benefit when EPA identifies hazards early and sets appropriate limits. For workers, that may mean exposure controls, personal protective equipment, or restrictions on certain processing conditions. For the environment, it may mean limits on releases to water, air, or land. For consumers, it may mean preventing certain uses until more data are available.

At the same time, public health protection depends on speed as well as caution. If safer new chemistries are delayed indefinitely, older substances may stay in use longer. That is why GAO’s report is not just about paperwork. It is about building a review system that can be both protective and predictable.

Why This Matters for Manufacturers and Innovation

For manufacturers, time is not an abstract concept. A delayed chemical review can affect contracts, product launches, customer relationships, investment decisions, and supply chain planning. A company may spend years developing a new material only to face uncertainty during regulatory review. Smaller firms may feel this more sharply because they have fewer resources to absorb long delays or hire specialized consultants.

Clear requirements can make a major difference. If companies know what data EPA expects, they can prepare better submissions. If they understand how EPA evaluates exposure, release, and hazard, they can design safer chemicals from the start. If they receive realistic timelines, they can plan production and customer commitments more responsibly.

This is where better communication becomes more than a courtesy. It becomes a risk-reduction tool. When EPA and submitters communicate clearly, cases are less likely to sit in limbo. Questions can be resolved sooner, missing data can be supplied faster, and risk management options can be negotiated with fewer detours.

Specific Examples of Improvement Opportunities

Clearer Guidance Before Submission

Manufacturers told GAO they wanted more clarity on minimum testing expectations, submission requirements, and how EPA uses information about chemical distribution, processing, and use. Better guidance could reduce incomplete submissions and avoid the dreaded regulatory guessing game, which is nobody’s favorite carnival attraction.

More Transparent Case Status Updates

Submitters may not need every internal detail of EPA’s scientific deliberations, but they do need enough information to plan. More granular status updates could help companies understand whether a case is in hazard review, exposure assessment, risk management, or waiting for additional information.

Improved Data Systems

CDX is essential because it is the portal for submissions. When the system is difficult to navigate, every technical glitch becomes a regulatory pothole. Better instructions, smoother workflows, and easier confidential business information tools could save time for both EPA and submitters.

Resource Planning

GAO emphasized that EPA’s strategic planning should identify the resources needed to meet goals. That means staffing, expertise, technology, training, and evidence-building capacity. Without resource planning, goals can become inspirational posters: nice to look at, less helpful when the inbox is on fire.

A Balanced View: Safety and Speed Are Not Enemies

The debate around EPA’s New Chemicals Program is often framed as safety versus innovation. That framing is too small. The stronger question is how to design a system where safety supports innovation. Companies that develop lower-risk chemicals should benefit from a review process that recognizes strong data, clear exposure controls, and thoughtful design. Communities should benefit from a process that does not wave chemicals through without adequate assessment.

GAO’s WatchBlog report points toward a practical middle ground. EPA needs strong science, but it also needs strong management. It needs stakeholder input, but not stakeholder capture. It needs faster reviews, but not careless approvals. It needs transparency, but also protection for legitimate confidential business information. In short, it needs the regulatory equivalent of a well-run airport: security still matters, but passengers should not have to live at Gate B12.

Practical Experiences and Lessons Related to EPA’s New Chemical Program

From a practical perspective, the story of EPA’s New Chemicals Program feels familiar to anyone who has worked around regulated innovation. The science may be sophisticated, but many of the everyday problems are surprisingly ordinary: unclear instructions, incomplete forms, overloaded reviewers, different expectations between teams, and deadlines that look great on paper until real life enters the chat.

One common lesson is that early preparation matters. A company submitting a new chemical notice should not treat the process like a last-minute homework assignment. Strong submissions usually begin long before the formal filing. That means gathering available hazard data, thinking carefully about uses and exposure scenarios, documenting manufacturing and processing steps, estimating releases, and preparing clear explanations for any data gaps. If a submitter waits until the portal is open to start asking basic questions, the 90-day clock may feel more like a kitchen timer attached to a rocket.

Another lesson is that communication should be planned, not improvised. Companies often focus on the technical dossier, but the way information is organized can shape the review experience. A clear narrative helps reviewers understand what the chemical is, how it will be used, who may be exposed, and what controls are proposed. If the submission reads like a drawer full of receipts, EPA staff may need more time to find the important facts. Good regulatory writing does not hide complexity; it guides people through it.

There is also a lesson for EPA. Submitters can handle strict standards better than uncertain standards. If EPA expects certain data for a class of chemicals, that expectation should be communicated as clearly as possible. If review timelines are likely to exceed 90 days, realistic updates are better than silence. Silence creates planning problems, and planning problems create frustration. Frustration, like glitter, spreads everywhere.

For public interest groups, the key experience is different but equally important. Communities want assurance that new chemicals are not being introduced without meaningful evaluation. They also want transparency about how EPA makes decisions. Even when confidential business information limits what can be disclosed, EPA can still explain general risk concerns, decision frameworks, and protective measures. Public trust grows when people can see the outline of the process, not just the final stamp.

The most useful lesson from GAO’s WatchBlog discussion is that better management is not a boring side issue. It is central to chemical safety. A program can have brilliant scientists and still struggle if it lacks performance measures, stakeholder feedback, resource planning, and modern data systems. Likewise, a company can have an innovative product and still struggle if it submits unclear information or underestimates review complexity.

In the best version of the program, EPA gets the resources and systems it needs, manufacturers submit complete and thoughtful notices, and the public receives stronger protection before chemicals enter widespread use. That is not fantasy. It is a management challenge. And unlike some chemistry problems, this one does not require a lab coat to understand.

Conclusion

EPA’s New Chemicals Program sits at a critical intersection of public health, environmental protection, and industrial innovation. GAO’s WatchBlog report and related audit did not argue that chemical review should be weaker. Instead, they showed that a stronger program needs more than scientific review alone. It needs systematic management, stakeholder engagement, resource planning, better communication, and evidence-based performance improvement.

The stakes are high. New chemicals can support cleaner technologies, stronger materials, safer products, and more resilient supply chains. They can also create risks if hazards are missed or poorly controlled. EPA’s challenge is to review these substances carefully without turning the process into a regulatory traffic jam. GAO’s recommendations offer a practical path: make the program clearer, better managed, and more accountable.

If EPA can improve timeliness while maintaining rigorous safety review, everyone benefits. Manufacturers gain predictability. Workers and communities gain protection. Consumers gain confidence. And the chemical review system gets a little closer to what it should be: a smart gatekeeper, not a mystery maze with fluorescent lighting.