Is the Toxic Substances Control Act (TSCA) broken? I don’t think so.

TSCA grants tremendous authority to EPA to regulate both new and existing chemicals throughout their life cycles.

  • EPA can collect pretty much any information it wants on chemical activities – prior to new chemical manufacture or about existing chemicals.
  • Riding as a watchdog over all chemical manufacturers, importers, processors and distributors is the powerful section 8(e) reporting requirement for information that reasonably supports the conclusion that a chemical presents a substantial risk. Through fear and aggressive, multi-million dollar fines, EPA has so lowered the threshold for what constitutes "substantial risk" information that companies turn in anything that hints of potential concern. Furthermore, companies promise to control exposures and conduct additional testing voluntarily to minimize adverse actions by EPA and negative public relations.
  • New chemicals can be prevented from being made or made under a variety of conditions for labeling, use, disposal practices, etc. Mandatory toxicity testing can also be required either before commercial manufacture or at some prescribed production level. Knowing what's in store for certain categories of new chemicals, manufacturers carefully pre-screen the ones they put through the Premanufacture Notification (PMN) process.
  • EPA is authorized to place virtually any restriction, up to and including stopping manufacture and use for an existing commercial chemical.
  • But EPA is required to protecting confidential business information, applying rules that are "reasonable" and "necessary for the effective enforcement of the Act."
  • If rulemaking is going to take too long, EPA can go to district court for immediate seizure and relief if there is an imminent hazard likely to cause injury to health or the environment.

TSCA denigrators will admit that EPA is pretty successful at managing new chemicals by applying a heavy measure of an unofficial precautionary principle where there is insufficient mitigating data. But they still bemoan the lack of dead rats. Not enough toxicity testing! Not enough data to prove safety! (By the way - you never can have enough data to satisfy these guys, because there are always more species and more health and environmental effects to check out.) Companies are getting off cheap! Plus,they are able to hide their trade secrets from the public (which includes competitors), so obviously, something suspicious is going on!

But it's the lack of chemical bans under TSCA that particularly maddens the denigrators. The burden for EPA to ban or severely restrict existing chemicals is too tough, they say.

Is the hurdle high for EPA to regulate existing chemicals? You bet. Professor Joel Tickner, of the University of Massachusetts, Lowell - a bastion of toxic chemical use reduction - explains (in an article in Chemical & Engineering News January 8, 2007):

"To restrict a chemical already in commerce, EPA must demonstrate an unreasonable risk, which requires strong toxicological evidence, as well as show that the benefits of regulation outweigh the risks of not regulating and that EPA's chosen restriction is the least burdensome means to reduce risk to acceptable levels."

EPA can severely impact a company's business that uses a chemical as well as impact that company's customers. All of these companies probably will have to spend more to make or buy an alternative (if there even is one), which will result in lost income and likely be offset by firing employees. So before EPA can do that, it has to:
1. have a basis to say that there is real risk to health or the environment and
2. show the costs of the restrictions are outweighed by the benefits to health/environment
3. use the lowest cost way to lower the risks to acceptable levels.

Sounds pretty reasonable to me. Before EPA impacts my paycheck or takes away a product I rely on, I want to know it's necessary to protect my health and environment.

But Tickner chides EPA for having "... neither the resources nor the ambition to apply these regulatory authorities under TSCA. " (Note he does not complain about inadequate authority.)

Does he and fellow TSCA denigrators want to allow EPA, based on a "hunch," to drive one or more companies into bankruptcy? I know there is no such thing as certainty when it comes to risk assessment. There's always going to be incomplete data. It's hard to put a specific number on the benefit of a lower probability of harm (what's it worth to have a 1/100,000,000 vs a 1/100,000 +/- 50% chance of getting cancer?). Furthermore, companies are going to claim it'll cost more than it will turn out they can deal with because American industry is innovative and usually can find a solution - eventually. But to go so far as to ban a chemical is going to hurt real people economically. Losing your job is not a healthy thing. So EPA should have a decent hurdle for such a drastic action.

"All chemicals are guilty until proven innocent" appears to be the mantra of TSCA denigrators. Which is certainly the reverse of the premise of TSCA for existing chemicals, which recognizes their economic value. Shifting the burden of proof to industry won't work - especially where anything paid for by chemical manufacturers is suspect and the concept of "enough" is not applicable to "proving" safety.

Does EPA make it harder on itself than it has to for existing chemicals? Are they too afraid of being challenged in court? Yes. Could they be more creative? For sure.

One area EPA has not adequately exploited is extending the use of categories for existing chemical substances. EPA should creatively define categories by risk characteristics - toxic structures, physical and chemical properties of concern (e.g., persistence) combined with exposure scenarios (e.g., release to waterways) - as the basis for collecting information and for setting regulatory requirements that would reduce risk.

RISK: the combination of hazard or toxicity and exposure. Everything will kill you if you get enough exposure - from picograms of plutonium anywhere near your body to aspirating water into your lungs to a cement block falling on your head. TSCA denigrators don't like to deal with risk - it's too hard. Just deal with "intrinsic toxicity" and ban it. Sorry, life is all about balancing risk - and it's hard to do. But necessary.

Nanotechnology is an area where categories based on risk - collecting information to validate theories on risk - is particularly ripe. Focusing on exposure as well as physical parameters of size could appropriately narrow the burdens placed on this new promising technology without strangling it.

Europe's REACH approach on very persistent, very bioaccumulative and very toxic chemicals is a good risk-based category that appropriately raises the bar to require manufacturers/users to show economic necessity and careful control of exposure on a category of likely high risk chemicals. Banning chemicals solely on the basis of one or the other of the three PBT characteristics is not appropriate. Risk = toxicity + exposure. EPA deals with new PBT chemicals well. Should it be more aggressive for existing PBT chemicals? Certainly EPA can press for more information to make the findings of risk that could determine what steps to manage exposure are necessary. (By the way, I think REACH as a whole will bury the new EU EPA as it uses the assumption of guilt approach by collecting enormous amounts of information it cannot process and overwhelm companies with a logistical nightmare of reports and reqruie extensive implementation compromises.)

EPA should use more intermediate steps in regulating existing chemicals - short of a ban. There are lots of ways to reduce exposures short of abstinence: labeling, training, acceptable methods of disposal, etc. There's an attitude of all or nothing when EPA begins rule-writing under TSCA for existing chemicals, in which case the hurdles are, and should be, incredibly high. Instead, mandating good product stewardship practices should be more straightforward and reasonable rulemaking. The big companies (those more likely to sue) will already be doing such risk management and are eager to level the playing field with competitors.

My read on the primary the root cause for EPA's seeming paralysis under TSCA (for the >80,000 existing chemicals) is an inability to set priorities and focus on the relatively few chemicals that do present an unreasonable risk to health and the environment. EPA continues to collect and review mountains of data on thousands of chemicals and takes little substantive action. They'd do better collecting less information so they could follow up on high risk candidates.

The authorities already exist in TSCA to manage the life cycle impacts of chemicals, new and existing. Taking away the checks on EPA to ensure beneficial regulations that focus on unreasonable risks would threaten the stability and sustainability of our economy. We need industry to spend its resources on innovative solutions that reduce risk - whether through exposure controls or developing new chemistries and processes - and not on fruitless reporting or fighting unnecessary proposed restrictions.

Encouraging are the exciting voluntary programs in EPA's TSCA program office:

Design for the Environment (DfE), the nanotechnology product stewardship effort, as well as work on High Production Volume (HPV) testing and others. These programs are building models for improved life cycle chemicals management and development without a lot of the baggage of regulatory action. Once mature, they will likely serve as the basis for good risk management-based regulations.

No, TSCA is not broken. It remains the most powerful authority EPA has. We should be spending our energies on how to best leverage TSCA, not on how to rewrite it.

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