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Unpacking The Toxic Substances Control Act Reform Bill

sandra-edwardsThe U.S. Senate and House of Representatives have passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals.  The bill amends TSCA for the first time in forty years to ensure that only human and environmental health are considered in assessing the safety of chemicals.  Under the new bill, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, all chemicals in commerce will be reviewed by U.S. EPA to consider—without regard to cost or benefits—their health and safety impact.  The legislation also shifts the burden and cost of evaluating and regulating chemicals to manufacturers, along with imposing new fees.  EPA’s oversight of chemicals manufactured, sold or distributed in the U.S. will be greatly expanded, as will be the processes by which chemicals may be approved.  The reform legislation will now be sent on to President Obama, with every expectation he will sign it.

The regulation of existing chemicals will be bifurcated into two steps: (1) risk evaluation of a chemical and (2) risk management of chemicals found to be problematic.  The first step in deciding whether regulation is warranted is to conduct a scientific evaluation of the risks without regard to cost or benefits.  If EPA concludes the chemical’s use presents an “unreasonable risk,” EPA is required to issue a risk management rule.  The rule may range from requiring labeling or notice requirements to putting into effect an outright ban on the use of the chemical.  To the extent practicable, the cost and benefits of the rule and the cost effectiveness of the regulation must be considered as a factor, but is not determinative. 

For new chemicals, EPA will be required to review and make an affirmative finding about the level of risk posed without regard to cost.  And indeed, the chemical may not be commercially produced until EPA rules on it, and it cannot be produced without being in compliance with EPA restrictions on that chemical.  EPA must make a determination about, and choose the regulation for, a chemical within 90 days, but no later than 180 days if more time is needed.

Some additional key points of the legislation include:

  • Requires EPA to identify individuals and groups relevant to assessing the safety of a chemical, including risks to relevant populations and ensuring their protection.
  • A mandate for EPA to review the risks posed by chemicals in active commerce, thus eliminating the existing grandfathering-in of chemicals in use without any risk evaluation.  This will require companies to identify all chemicals they are currently making or processing, with EPA to establish the priority of active chemicals.
  • In establishing the priority of active chemicals, EPA must ensure high-priority chemicals undergo full safety assessment and safety determinations.  For any chemical that does not meet the safety standard, EPA must impose restrictions sufficient for the chemical to meet the safety standard; where restrictions cannot ensure the safety standard will be met, EPA must ban or phase out the chemical.  To the extent sufficient information exists, EPA may conclude a chemical is likely to meet the safety standard, and is therefore a “low priority” chemical.

Notably, the bill will allow EPA to issue an order requiring testing, rather than having to promulgate a rule, avoiding the multi-year process typically associated with rulemaking.  Testing authority applies to both new and existing chemicals, and in limited instances may also be applicable to the prioritization process.  Historically, the rule making and consent agreement processes were lengthy and slow, so that EPA is likely, going forward, to simply order a test.

Several provisions of the bill also alter the process for the handling of Confidential Business Information (CBI) in ways that will impact manufacturers.  Companies seeking to protect the specific chemical identity of a chemical substance will be required to submit a notice to EPA substantiating the confidentiality of the chemical compound, and substances for which no notification of CBI are received will be placed on the non-confidential portion of EPA’s §14 database list of regulated chemicals.  The bill requires EPA to develop a retroactive review plan for evaluating whether chemicals on the existing list require CBI protection, or whether they can be placed on the non-confidential portion of the list.

The issue of preemption was one of the sticking points in the effort to reform TSCA.  The result, and one way in which the new legislation differs from the existing TSCA, is that if EPA decides a chemical does not present an unreasonable risk and requires no regulatory action, that decision preempts state laws that may contradict that finding.  Preemption of state and local law begins when EPA defines the scope of a risk evaluation, and ends either 30 months later or when the risk evaluation is completed, whichever is earlier.  This does not restrict the state from enforcing a law enacted prior to risk evaluation, and federal preemption applies only to the scope of the risk evaluation and to the significant new uses under Section 5 of the Act.  There are additional exceptions for, among other things, existing state laws and regulations. 

Until the legislation is signed into new law, there may be further changes to the bill.  I will provide a further update once the final legislation is released.

Sandra A. Edwards is a partner in Farella Braun + Martel’s San Francisco office and chairs the firm’s Environmental Law Department. She can be reached at sedwards@fbm.com.

Sandra A. Edwards
Sandra A. Edwards is a partner in Farella Braun + Martel’s San Francisco office and chairs the firm’s Environmental Law Department. She can be reached at sedwards@fbm.com.
 
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3 thoughts on “Unpacking The Toxic Substances Control Act Reform Bill

  1. Perhaps they could reduce the burden on industry by excluding everything with a NFPA code of ‘0’ or ‘1’ from even cursory examination. Things like SD alcohols and extracts of natural products can pose no conceivable hazard.

  2. Only good can come from total success of the Bill but it is incomplete. This application of a precautionary principal is flawed by a 180 day maximum period, which stresses the examination facilities and will become a part of the commercial (and to use a sometimes dismissed word ‘evil’) deviousness which this plan will have already attracted and will accelerate in reaction once embedded in law. Typically when decisions are not made within maximum periods the result is empowerment of the applicant through the default.
    “Government” excuses will be made for chemicals which continue to increase the US stockpile of neurological and physiological weaponry and those which work to disable the minds of those who are their targets in what has become the insanity gripping superpowers and the type of people wheeled-out for election to say, Presidency.

    To work with genuine transparency, not ‘confidentiality’ obsfuscation, every chemical in existence must be reviewed and production ceased where the interest of the environment and ecosystems are risked. Every company and government agency totally involved in total audit for stockpiles and ‘confidential’ chemicals which are destroying us all…It’s long overdue, but time now to say “No More!!”

    What is the “commercial quantity” not to be produced? A pound? or 10,000 tons?. Nothing has been said in the article concerning waste-disposal and the chemical combinations which emerge during the commonplace events of incomplete incineration and after it, nor the particulates and their attached chemicals which enter the air, ground and waterways.

    How well will present and future waste now be audited? With attention turning to chemicals? …what action will be taken to make this Bill just one part of a “P.D.C.A.” continuum which may help save the human race, presuming one sees a benefit in that because the ecology probably doesn’t and of all species we least deserve to be here looking at our history as well as around us right now.

    What controls will be impassably in place? Companies will continue to squirrel-away and ultimately dump harmful chemicals very likely using the highly developed and disciplined criminal second-tier “underworld” American government which accelerated in the 17th Century to become ‘government-empowered during WW1 and WW11. These hidden chemicals will perhaps be mixed in with the so called ‘accidental’ oil spillages or being ‘lost at sea’ with containers “washed overboard” and ships sunk. They may be ‘destroyed’ in sacrificial factory fires, or dumped in forests and bushfires started, as well as being transported to ‘third world’ nations….. It is quite feasible they will also be stored in Tsunami-‘prone’ or oft-flooded areas to be washed out to sea. It is already obvious that money and power have no conscience. The farce of ‘oil spills’ and ship wreck is of itself an indicator of national powerlessness and reticence towards arresting planetary ruination.

    I appreciate the article is about the Bill not my extrapolations …however the Bill cannot stand alone as a cure. Nothing has been said in the article of the chemicals which are generated in landfill-waste which already enter homes and workplaces via conduits and pipes nor from composting and from ‘backyard’ burn-off, agricultural fires and bushfires along with resulting transport via erosion and ground- absorbed into water tables and the like….Nothing has been said of the invasion of chemicals through the techno-frenzy which has contributed so much to the mindless (my view) accepting of globalisation and the deliberate alienation of new and older generations through ‘social media’ with its own neuro toxins which seemingly outweigh any good it does.

    Whilst I applaud the apparent intervention of this Bill, I see it as incomplete and vulnerable to the forces which will rally to weaken it and bypass it. To imagine that this Bill will operate in a vacuum of good-will without conspiracy, connivance and obfuscation by the forces of ‘evil’ is, I think, futile. Some will argue the importance of controversy, but it’s too late to messing around. If the world is to be turned from its headlong flight into climate-change and eco-poisoning/destruction assisted by civilian generated and ‘vast’ amounts of completely ignored military chemicals and the self-destruction they are wreaking it has to go further, something American power seems incapable of doing when pursuing good rather than evil owing to the alien control Congress proved inescapably to Obama.
    To reduce environmental dangers this Bill should be expanded and made completely transparent, in every aspect including every application, conversation and government processing not in any way or for any reason made ‘confidential’. Those it is said to be saving should get involved. Whatever reaction this brings from its power-mad, greed driven, depraved colleagues and fifth columnists in universities and congress, deeply embedded in the Military and Health systems and in commerce must I think become the stimulant to the American people to act for themselves and say “No More”, begin a science revolution in which every product has to prove its harmlessness to the environment and eco-systems.

  3. I’m sorry, but I do not see how you interpret that this law either constitutes or precludes what might be called any “precautionary principle” in EPA policy making. Would like to know how it equates to that.

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