Impacts of the Safe Chemicals Act

 

TSCA regulates the introduction of new chemicals as well as existing chemicals in the U.S. EPA database. “The idea is to make sure that whatever chemicals are introduced are safe,” says Mr. Hayes. “So as TSCA exists today, before a company introduces a new chemical, it must submit to the U.S. EPA a premanufacturing notice—an assembly of all existing, complete studies on the chemical.” These rules also apply to any significant new use (SNU) of a chemical that has already been approved. The EPA then studies that existing information and makes a decision to approve or disapprove the use of the chemical.

 

EPA has authority under TSCA to regulate the manufacture (including import), processing, use, distribution in commerce, and disposal of chemical substances and mixtures. EPA may ban the manufacture or distribution in commerce, limit use, require labeling, or place other restrictions on a chemical that poses an unreasonable risk, where “unreasonable risk” is a risk-benefit standard. EPA must consider risks, costs and benefits of a chemical, including its benefits and the availability of substitutes.

 

Mr. Hayes sees two areas of consideration for revising TSCA. “When someone has a new chemical, instead of only looking at existing information, some feel a minimum data set should be required,” explains Mr. Hayes. “The chemical should be studied to make sure certain specific questions are answered about it. This is a significant change from only requiring submittal and review of the information that’s already out there.” The other consideration involves the chemicals that have already been approved—more than 84,000 of them. Much more information is available about many of these chemicals now than when they were approved. Mr. Hayes says that the proposal now includes a schedule for revisiting existing approved chemicals, also requiring a minimum data set based on information that has since been made available.

Picture this scenario. A company has been using a chemical for 20 years, cleaning molds that have proven overly sensitive to other options. Suddenly, the EPA decides this chemical can no longer be used. Now this company must scramble to find an alternative to replace the chemical it has come to rely on. Considering all of the chemicals in use today, many facilities have developed a strong reliance on a few certain products. Mr. Hayes especially encourages companies in this situation to follow the TSCA developments closely so they are prepared to act. “If the chemicals that they use are early in the schedule¹, they definitely need to keep an eye on it,” he says. “If they have information that can help in the approval process, they should submit it. If they can access any other existing studies, they should look at those and determine the level of risk they are facing. In the worst case, if the EPA eventually determines that the chemical is not safe, they need to be prepared with alternatives for their operations, and they need to consider the long-term effects should workers make claims against the company for previous use of a chemical suddenly determined to be unsafe.”

 

Another significant change being considered in TSCA reform affects claims of confidentiality. Currently, when submitting information for a chemical, claims for confidentiality are generally approved. But as Process Cleaning reported last year, the U.S. EPA has already stated its intention to tighten the confidentiality process and increase transparency in reporting under the TSCA. There will soon be a higher standard to meet to keep the information confidential, but that’s only the tip of the iceberg. The bigger concern is that the appeal process is being eliminated, and given the short time schedules for chemical reviews, companies may be left with some surprise decisions.

 

“A company may have 90 percent of its business in a certain chemical,” explains Mr. Hayes. “It shows up on the schedule for review, so the company needs to submit all of the related data to the EPA. To protect the business, it requests confidentiality. But then the paperwork ends up in the hands of an EPA employee who is overworked and has only 60 days to make a determination. If that EPA employee makes an arbitrary decision to deny confidentiality, fair or not, the company has no recourse and all of the company’s competitors will quickly have access to all of the secrets of the chemical.”

 

Considering that many chemicals can take years to develop, the possibility of giving up the secrets to that development in a matter of days is a serious deterrent for further chemical advances. And to take it a step further, even if confidentiality is approved, it will only last for five years under the new proposal. Experts like Mr. Hayes are concerned that this shortened window of confidentiality will have the negative impact of eliminating incentives for companies to invest in the development of new chemicals.

 

A more ambiguous part of the legislation is how nanomaterials will be governed. But one thing that’s clear is that the EPA will specifically target these materials. Nanomaterials are becoming very prevalent in many areas, including consumer products, aerospace applications and coatings, and there is widespread concern, especially given their further rapid development, about finding ways to study them quickly.

 

But the exposure pathways for these materials vary greatly from other chemicals, so the data set will be difficult to determine. Some studies show that because of their size they are easily absorbed into the bloodstream, while other reports state that they tend to clump together, thus hindering absorption. Traditionally in environmental regulation, the more of a substance, the worse it is, but with nanoparticles, more could actually make them safer.

 

Another question arises when existing chemicals are brought down to nanoscale. Are these now new chemicals or do they fall under the prior evaluation of the original? Given the variables and how the impacts are so different, it is clear that nanoparticles will require their own treatment under the legislation.

Mr. Hayes believes the final reforms to TSCA will be set in place during the fall of 2011. Currently, two separate committees are putting together proposals for the act, but these proposals will eventually be merged.

 

The recent elections might have a slight effect on who will chair the committees, with assignments targeted to be in place by the end of January. But the TSCA amendments relate to safety issues, and even though there is significant impact to industry, no politician, Republican or Democrat, wants to be on record as pushing back on safety legislation. The schedule of implementation for specific chemicals will be set up through the act, but the EPA may be open to negotiations from business.

 

Mr. Hayes’ most poignant advice to businesses is to pay close attention to the developments of the legislation and get involved where possible. “Larger entities will utilize trade groups as their voice,” he says. “I would suggest companies stay in contact with their trade organizations and express their concerns. Make sure trade organizations are involved because they should already have a presence in Washington.” In other cases, trade groups may not be willing to expend the resources to help a company with a unique situation or chemical, and that is where the company will need to take the initiative according to Mr. Hayes.

 

He suggests that companies also take a close look at and inventory the chemicals they are currently using and consider if there are better alternatives. “There are so many more aqueous cleaners out there, for example, that don’t have ozone depleting substances. We have had many clients who were in a sort of panic about finding replacements when CFCs were banned, but if you work at it, there’s always a solution. Unfortunately, it’s easy to get into a routine of doing things the way they’ve always been done. So before a company is under the gun, they should evaluate the alternatives. Make a thorough inventory of the chemicals in use and what they are used for, and the reasons they were selected over alternatives.”

 

 

One of the biggest concerns expressed about TSCA reform is that new regulations will hinder advancements in the development of new chemicals. Everybody wants greener chemicals, but if it is regulated too heavily, companies are not going to want to make the investment necessary for further development. And it’s a double-edged sword, with potential to slow both economic growth of the companies and the development of safe alternatives. Mr. Hayes says, “It’s called the Safe Chemicals Act, but if it doesn’t assist in moving towards cleaner alternatives, then it’s self-defeating.”

 

While it’s important to consider all of the potential effects of the new legislation, it should also be noted that some chemicals may fly under the radar. Even if a chemical shows problems, the EPA could decide to keep it if there is no alternative. A potential example of this situation applies to military and strategic applications. Some applications remain too important to be cut off by the EPA if no alternative exists. PC