Myth Versus Fact About Chemicals in Commerce
The Toxic Substances Control Act (TSCA) is a US statute enacted in 1976 that manages industrial chemicals. It covers a broad range of chemicals, although it exempts things regulated under other Federal statutes, such as:
- Tobacco or tobacco products,
- Radioactive substances and firearms,
- Articles (solid manufactured items, essentially), and
- Food and feed, food and feed additives, drugs, cosmetics, medical devices
Over the years there has been an emergence of international chemical control laws, a patchwork of state and local laws, and continued negative publicity of high-profile chemicals. The result has been rising criticism of TSCA from many fronts, especially NGOs, Congress and state governments. And, perhaps surprisingly, industry agrees with many of these criticisms.
The TSCA statute has recently gotten more attention than ever, leading to numerous bills being introduced and a number of Congressional hearings. Most stakeholders now agree that the time has come to modernize the statute. Most also agree on the broad outlines of the solution, although the particulars are yet to be ironed out. Yet despite all the dialogue and progress of the last few years, widespread misinformation about the statute remains. While TSCA has some admitted shortcomings, the statute has actually accomplished a great deal. Most important, it has enabled EPA to review the introduction of over 20,000 chemicals into commerce, while still allowing the United States to remain at the forefront of chemical innovation. TSCA requires some carefully tailored fixes, not wholesale replacement.
In order for TSCA modernization to take place productively, the facts need to be clearly understood. A lot of “received wisdom” about TSCA is really mythology. If TSCA reform is based on these myths, we risk dismantling the aspects of TSCA that have worked so well.
Myth: There are 80,000+ chemicals in commerce.
The TSCA inventory was created back in 1977 under the authority of TSCA section 8(b), which requires EPA to compile, keep current, and publish a list of each chemical substance that is manufactured or processed in the United States. The initial TSCA Inventory, published in 1979, and updated in 1982, included approximately 62,000 chemical substances. Thereafter, EPA added every chemical substance that successfully underwent its new chemical review process (called the “Pre-manufacture Notification” or PMN process) and subsequently went into manufacture. As a result, today more than 84,000 chemical substances are on the Inventory.
The TSCA inventory is not, however, an accurate reflection of what chemicals are currently in commerce. The 84,000 chemicals figure is misleading in several respects:
- Most fundamentally, there is no process for EPA to delete a chemical if it stops being manufactured. Well over half of the chemicals on the Inventory are probably not in commerce anymore.
- Some chemicals that are manufactured do not make it onto the Inventory because they meet certain exemption criteria, including:
- Products produced in low volumes,
- Products produced in ways that assure low release to the environment and low exposure of people,
- Products produced for test marketing,
- Certain polymers
- R&D materials.
The total number of exempted chemicals is still probably in the low 10,000s. There have been estimates that about 25,000 chemicals are actually currently in commerce; however, the exact number is unknown. EPA’s most recent snapshot of chemicals in commerce from the 2012 chemical data reporting (CDR) rule, formerly called the inventory update reporting rule, captured 7,674 chemicals from 2011. According to EPA’s 2006 Inventory Update Reporting Summary 6,200 chemicals were reported as being in commercial use during 2005. Another source of data on chemicals in commerce, prepared for the National Pollution Prevention and Toxics Advisory Committee in 2005, can be linked here.
Myth: We don’t know anything about the chemicals on the TSCA inventory of existing chemicals
Critics point to the relatively low number of “test rules” that EPA has issued for chemicals on the TSCA inventory as support for claims that we know little about them. These figures are particularly misleading.
First off, roughly 22,000 of the chemicals on the Inventory have been reviewed by EPA under its new chemicals program. EPA has conducted screening assessments of all these chemicals. It has collected an abundance of information on chemicals that raised concerns based on that screening. All this occurred before those chemicals even entered the marketplace.
Manufacturers have voluntarily supplied EPA with vast amounts of test data on many existing chemicals, including the 2,000+ high production volume chemicals that make up approximately 95% of U.S. chemical production by volume.
Manufacturers are required by TSCA Section 8(e) to immediately alert EPA to any information they obtain indicating that a chemical presents a substantial risk of injury to health or the environment. EPA had received over 16,000 8(e) notices between TSCA’s enactment and 2006. Manufacturers typically err on the side of disclosure, making many “FYI” filings that may or may not show substantial risk.
EPA periodically collects data on chemicals via its chemical date reporting (CDR) rule (mentioned above) that provides a snapshot of which chemicals are currently being manufactured during a given year, how they are being used, and what sorts of exposures they may produce. EPA has expanded these reporting requirements and posted the results of this exercise online. As EPA enhances its reporting requirements and information gathering tools, a greater understanding of chemicals in commerce can be expected.
Myth: There is a significant information gap about chemicals in commerce.
The fact is that EPA has never publicly stated how much data it actually has in its files. The only information provided on chemical testing is the number of regulatory actions EPA has taken to compel testing, which is misleading. As noted above, EPA has collected information on thousands of chemicals through its new chemicals program, consent agreements and voluntary programs, Section 8(e) reporting, and the CDR rule. There is no way to tell the real size of any information gap until EPA discloses how much information it actually has.
When one hears that there are more than 80,000 chemicals in commerce and, of those, fewer than 300 have been tested and only 5 restricted, it is understandable this would raise some eyebrows. As explained above, however, the first of these two numbers are patently inaccurate. The third statistic is also erroneous. EPA has regulated over 2,000 new chemicals through the PMN process (and almost as many PMNs have been withdrawn). EPA has restricted many existing chemicals through the “significant new use rules” or SNURs that it issues in connection with reviewing new chemicals. EPA provides some useful statistics here on its new chemicals accomplishments. TSCA is a statute that has accomplished a lot since it was enacted in 1976, and it will be able to do much more with carefully tailored enhancements.
Clearly the large majority of chemicals on the Inventory are not currently being manufactured. EPA is currently taking steps to prioritize among the remaining existing chemicals, which is good news to all stakeholders. The single greatest way to prioritize would be to take off the list all those we no longer need to worry about – the so-called “Inventory Reset.” Certainly the agency should not waste time and resources collecting or analyzing hazard data for chemicals no longer in commerce. If EPA really wants to address this fundamental criticism of its current TSCA program, it then needs to prioritize all existing chemicals in the same step, through a comprehensive screening program of the sort that Canada has successfully implemented. The agency has made great strides by making the inventory easily accessible to the public, but more work needs to be done to make it a more useful list.
Myth: The chemical industry is hiding information on chemicals in commerce.
The fact is that industry provides EPA a plethora of information on chemicals, including highly proprietary information. For example, in a case where the chemical identity of a substance is not divulged, it is known to EPA, which is able (and legally obliged under the current TSCA statute) to evaluate the safety of the substance. Also, the generic chemical name is available to members of the public. Generic names provide the needed balance of public right to know and protection of US intellectual property. Furthermore, health and safety information on chemicals in commerce is required to be publicly disclosed under TSCA. Other federal statutes, such as the Occupational Safety & Health Act (OSHA) require the results of any toxicity and hazard studies regarding the chemical to be available via the product’s Material Safety Data Sheet (MSDS), which is a document that is readily available to the public via most companies’ websites. Lastly, the Emergency Planning and Community Right to Know Act (EPCRA) allows a treating physician to get access to confidential business information without a previous confidentiality agreement in emergency situations.