By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

The Environmental Defense Fund applauds the Environmental Protection Agency (EPA) for meeting a major milestone in implementing the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the landmark legislation reforming the Toxic Substances Control Act (TSCA) that passed in June 2016 with overwhelming bipartisan support.

EPA reached this milestone this week when it released proposals for the three foundational rules that the Lautenberg Act mandates be finalized by June of this year, as well as three proposed rules restricting specific high-risk uses of several chemicals.

The management and staff of EPA’s Office of Chemical Safety and Pollution Prevention and Office of General Counsel deserve major kudos for their tireless work over these past seven months to reach this milestone. This should also bring satisfaction to the Members of Congress who authored the Lautenberg Act and included aggressive deadlines as part of the bipartisan effort to reform the law.  

Shortly after passage of the Lautenberg Act, EPA issued an implementation plan that called for proposal of each of these rules by about this time, in order to pave the way for the rules to be finalized early in the next Administration.  At the time, a broad range of stakeholders voiced their support for EPA’s plan and stated that the agency could and should meet this timeline for proposing these rules.

All six of these proposed rules are now open for public comment.

A fourth foundational rule to establish a fee system is under development; while it is not subject to a statutory deadline, we understand considerable progress has been made and it is on track to be proposed a little later this year.

In addition, in November EPA also met its 6-month deadline under the law for identifying the first ten chemicals to undergo risk evaluations.  Finally, EPA also promulgated its long-awaited rule requiring reporting of nanoscale materials under TSCA; our blog post on that final rule is here.

Below we provide links to each of these rules as well as EPA’s announcement of the first ten chemicals.

In the coming days, EDF will be reviewing each of the six proposed rules and providing more information via our blog.  (We have already posted on EPA’s proposed rules restricting certain uses of trichloroethylene (TCE):  here and here.)

So stayed tuned!

Links

Foundational procedural rules

• Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act
• Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act
• TSCA Inventory Notification (Active-Inactive) Requirements

Chemical-specific risk management rules

• Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses under TSCA Section 6(a)
• Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing under TSCA Section 6(a)
• Trichloroethylene (TCE); Regulation of Certain Uses Under TSCA §6(a)

Other

• EPA Names First Ten Chemicals for Review Under New TSCA Legislation
• Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements

By Jennifer McPartland

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

The Environmental Protection Agency (EPA) took another significant step yesterday to protect against exposures to the highly toxic chemical, trichloroethylene (TCE), proposing a rule to ban its use as a vapor degreaser.

The proposed rule is the second issued under section 6 of the Toxic Substances Control Act (TSCA) as amended by last year’s Lautenberg Act.  It follows on EPA’s proposed rule last month to ban the use of TCE as an aerosol degreaser and spot cleaning agent in dry cleaning facilities. Both proposed rules on TCE are critical to protecting consumer and worker health from the harmful effects of TCE and should move swiftly toward finalization.  

TCE is a volatile organic compound, produced in huge volumes (255 million pounds in the US). It is highly toxic, with identified health effects ranging from skin and eye irritation and dizziness to cardiac malformations in the developing fetus and cancer. TCE is fat-soluble, easily crosses biological membranes, and has been detected in breast milk and maternal and fetal blood.

In vapor degreasing TCE is boiled in a degreasing unit, creating a hot vapor that upon contact with fabricated parts, condenses and absorbs and carries contaminants away. Vapor degreasing is conducted in many settings, such as electronics assembly and repair shops. EPA’s 2014 risk assessment of TCE found that current levels of exposure to the chemical from its use as a vapor degreaser pose unacceptably high levels of risk to workers and occupational bystanders.

The proposed ban on TCE’s use as a vapor degreaser would eliminate those risks and provide for healthier workplaces.

More specifically, EPA’s proposed rule:

• prohibits the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing;
• prohibits commercial use of TCE in vapor degreasing; and
• requires manufacturers, processors, and distributors except for retailers, to provide notification of this prohibition throughout the supply chain and to keep records.

Notably, EPA estimates the proposed rule would result in monetized benefits ranging from $65 to $443 million at a 3% discount rate on an annualized basis over 20 years based on reductions in cancer risks alone. The agency did not have sufficient information to additionally quantify the benefits of the non-cancer health impacts.

Lest anyone think that the Occupational Safety and Health Administration (OSHA) has adequate workplace standards to mitigate such risks, think again:  OSHA’s permissible exposure limit (PEL) for TCE was set way back in 1971. OSHA acknowledges that many of its PELs, including that for TCE, are not protective of worker health. It has noted that:

“with few exceptions, OSHA’s PELs, which specify the amount of a particular chemical substance allowed in workplace air, have not been updated since they were established in 1971 under expedited procedures available in the short period after the OSH Act’s adoption…Yet, in many instances, scientific evidence has accumulated suggesting that the current limits are not sufficiently protective.”

EPA’s proposed rule to eliminate the use of TCE in vapor degreasing is supported by strong science as necessary to protect the health of workers—a subpopulation specifically called out in the Lautenberg Act as “potentially exposed or susceptible” and required to be considered and protected in all chemical risk evaluation and risk management decisions.

By Joanna Slaney

Joanna Slaney is the Legislative Director for EDF Health.

EPA held a public meeting Wednesday on the implementation of the New Chemicals Review Program under the reformed Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act required EPA to begin implementation of the reforms to the program on the day the legislation was signed into law. The meeting was an opportunity to discuss the effort and progress to date.

As we’ve noted before, and as I noted on Wednesday, the changes made to the New Chemicals Review Program were fundamental to TSCA reform and the promise of a new system that better protects public health and the environment.

Representatives from state government, the Senate, NGOs, and industry gathered to hear a series of presentations by EPA about new chemicals reviews under the reformed law, scientific and data issues the Agency is navigating, and the types of information it needs from manufacturers and processors to facilitate a streamlined review process.

A series of oral comments from various stakeholders included a robust showing of support for EPA’s actions from public interest groups representing labor, the environment, and public health, as well as concerns from some in industry with certain aspects of implementation. EPA concluded with a commitment to meet again in six months to discuss its progress in implementing revisions to the New Chemicals Review Program.

A few of the notable stakeholder comments included:

Jonathan Black of Senator Tom Udall’s office read a statement from the Senator noting how essential the reforms to the New Chemicals Program were to him as an author of the Lautenberg Act. He said, “I would not have supported compromises in the package without them. . . New chemicals should not enter the market without findings based on safety and sufficient information and without restrictions necessary to prevent harm while sufficient information is being developed.”

Dr. Jennifer Lowry, representing the American Academy of Pediatrics, urged EPA to “continue its implementation of the new program to ensure as new chemicals enter commerce they do not pose risk to children.”

Racquel Segall, of the labor-environmental coalition Blue Green Alliance, spoke about the importance of “ensuring that products entering the market do not expose workers and members of the public to unreasonable risk.”

Melanie Benesh, an attorney at Environmental Working Group, said “EWG agrees with EPA's interpretation of the law and we think that speed and efficiency and market innovation are important goals but they should never displace robust review of chemical safety and concerns about public health. If we get the public health wrong up front, we may have bigger problems in the future.”

EDF also spoke in support of EPA’s progress. You can read our full oral comments here.

There is still an opportunity to weigh in on EPA’s new chemical review process. Written comments can be submitted to the docket until January 14th, 2017. For more information about opportunities to engage on implementation of the reformed TSCA, check out our Engagement Guide.

By Joanna Slaney

Joanna Slaney is the Legislative Director for EDF Health.

Today the EPA held a public meeting on the new requirements for the New Chemicals Review Program under the reformed Toxic Substances Control Act. EDF oral comments, as prepared for delivery, follow below.

Strong implementation restores public and market confidence.

EDF believes that the reforms to the New Chemicals program in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and the robust implementation of these reforms by the EPA, are absolutely essential to the task of restoring public and market confidence in our national chemical safety system. It is this shared objective, restoring public and market confidence, that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act in the first place. And without a strong New Chemicals program, there is no restored public confidence.

Without a strong New Chemicals program, there is no restored public confidence.

It’s a public health issue.

With between 500 and 1,000 new chemicals entering the market every year, ensuring the safety of these chemicals is clearly a public health priority. It is critical that new chemicals clear a safety bar before they are allowed in products and in our homes. For decades, chemicals have been allowed on the market simply because there wasn’t enough information to make a safety decision one way or another. In 2007 EPA reported that 85% of pre-manufacture notices contained no health data. That’s not right, and it puts the public’s health at risk, most especially the health of vulnerable populations like children, pregnant women, and workers. Any chemical entering the market should be reviewed and managed to provide a reasonable assurance of its safety. In fact, I expect that most Americans believe that their government already does so in order to protect their health and the health of their families.

It’s congressional intent.

Many in Congress worked hard to drive significant improvements to the new chemicals provisions in the new law; indeed, for some it was a central reason for their involvement in reforming TSCA. And the record is clear that even where certain Members were less inclined to see the need for change, they acknowledged that significant changes were made to the New Chemicals program as part of the compromise legislation. The changes that were made were a compromise on both sides but they were not insignificant, and the new requirements are clearly laid out in the language of the Lautenberg Act.

It’s a primary purpose of TSCA.

It has been argued that EPA’s implementation of the new chemicals program under the Lautenberg Act risks impeding innovation and is at odds with the intent of the law. In fact, the intent of the law is quite clear:

It is the policy of the United States that— authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.

While innovation is central, it cannot come at the expense of protection for public health and the environment. Innovation without safety is not true innovation.

The changes made to the New Chemicals program are fundamental to the reform of TSCA and the promise of the new system. Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA – providing an assurance that innovation and commerce in chemicals do not present unreasonable risk – to be realized other than through robust scrutiny of new chemicals prior to their commercialization.

The public has a right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  The lack of that basic assurance has undermined consumer confidence in our chemical safety system.  The most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.

Environmental Defense Fund supports the actions taken by EPA to date in implementing the New Chemicals Program and believes they are clearly required under the new law.  We look forward to EPA continuing to implement a robust New Chemicals program that can restore public and market confidence in our national chemical safety system, while both protecting human health and the environment and fostering safe innovation.

By Jennifer McPartland

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

Today, EPA issued a proposed rule to ban uses of trichloroethylene (TCE) as a spot cleaning agent in dry cleaning and as an aerosol spray degreaser in commercial and consumer settings. This marks the first time in 27 years EPA is proposing to restrict the use of a chemical and represents a significant milestone under the Lautenberg Act.

The proposed ban is long overdue for a chemical that is highly toxic and produced in very high volumes (255 million pounds annually). TCE is classified as a known human carcinogen by numerous authoritative bodies, including the National Toxicology Program (NTP), the Agency for Toxic Substances and Disease Registry (ATSDR), EPA’s Integrated Risk Information System (IRIS), and the International Agency for Research on Cancer (IARC). Many studies of TCE also reveal additional health impacts including but not limited to immune toxicity, developmental toxicity (e.g., fetal cardiac defects), and neurotoxicity (e.g., Parkinson’s disease).

The proposed rule summarizes the serious concerns:

These adverse health effects include developmental toxicity (e.g., cardiac malformations, developmental immunotoxicity, developmental neurotoxicity, fetal death), toxicity to the kidney (kidney damage and kidney cancer), immunotoxicity (such as systemic autoimmune diseases, e.g., scleroderma, and severe hypersensitivity skin disorder), non-Hodgkin’s lymphoma, reproductive and endocrine effects (e.g., decreased libido and potency), neurotoxicity (e.g., trigeminal neuralgia), and toxicity to the liver (impaired functioning and liver cancer).

EPA’s proposed rule follows on its 2014 risk assessment of TCE that demonstrated that current levels of exposure to TCE from these uses pose unacceptably high risks to workers and occupational bystanders in the context of dry cleaning and aerosol spray degreasing; and additionally, to consumers when used as an aerosol spray degreaser in residential settings.

Prompt finalization of this and other proposed rules in the pipeline (a second TCE rule addressing other uses and a rule to restrict two chemicals’ used in paint strippers) are necessary to protect public health and would represent the first tangible risk reduction actions taken under the Lautenberg Act.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

In the many conversations I have had over these last many years about the Toxic Substances Control Act (TSCA), the single thing that most resonated with people about why the old law didn’t work was about new chemicals. Folks were stunned when they learned that the old law didn‘t require our government to review chemicals and determine they were safe before they were allowed onto the market.  People simply assumed this was the case and were shocked to find it wasn’t.  I heard repeatedly, what could be a more basic need to ensure protection of the public’s health?

That is why many in Congress worked so hard to drive improvements to the new chemicals provisions in the new law – that, and a clear understanding of the many ways in which the old law hamstrung EPA when it came to new chemicals.  In my view, these reforms and robust implementation of them by EPA are absolutely essential to the task of restoring public and market confidence in our national chemical safety system – the shared objective that allowed disparate stakeholders and lawmakers to come together to support the Lautenberg Act.

For too long, economic factors have dominated over the public’s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  That has undermined consumer confidence in our chemical safety system.  The public understands that the most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.

I have blogged previously about why the new chemicals reforms in the new law represent a balanced approach, on the one hand, ensuring that the safety of new chemicals is carefully examined and a reasonable assurance of safety is provided before market entry; and, on the other hand, ensuring an efficient process that doesn’t unduly slow or create too high a bar for market entry.

Of course, even as it has supported the new law’s balanced reforms, the chemical industry did and continues to assert that the old new chemicals system worked just fine.  I’ve always maintained that’s because it rarely required much of them.   It’s not wholly surprising, therefore, that the industry is expressing angst over EPA’s implementation of the new requirements.  Change is hard.

Bear in mind also that the new requirements of the law not only changed the status quo significantly, they also became effective immediately upon passage of the law, without any time given to EPA to migrate to the new regimen.  That, too, has been a source of the growing pains felt by both EPA and the regulated community.  Abrupt change is even harder.

But a broader and longer view of the new law is called for.  The bulk of this post will describe why EDF believes that EPA’s implementation to date is not only consistent with the new law but in fact mandated by it, and why, despite initial growing pains, the new system will be a major improvement over the long run for both public health and business.  But first …  

Playing the “don’t-stifle-innovation” card

But before doing so, I want to briefly address an overarching argument that industry uses to try to lend greater weight to its complaints about EPA’s actions under the new law:  that those actions threaten to impede innovation, which they assert is directly at odds with Congress’ intent under TSCA.

This claim relies on the only reference to innovation in all of TSCA, in a list of the law’s policy intentions (section 2(b)(3), same language in both the old and new law).  Industry typically paraphrases this provision as saying that, under TSCA, EPA shouldn’t act in a manner that impedes innovation.  But that is a selective reading of the actual provision; I quote it in its entirety below (emphasis added):

(b) POLICY.—It is the policy of the United States that—

…

(3) authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.

Given that the development and application of new chemicals are a clear source of innovation, how else is that primary purpose of TSCA – providing an  assurance that innovation and commerce in chemicals do not present unreasonable risk – to be provided other than through robust scrutiny of new chemicals prior to their commercialization?

Congress clearly got it that innovation without safety doesn’t really qualify as innovation.

New chemical reviews under old vs. new TSCA

The Lautenberg Act made five major improvements to the new chemicals provisions of TSCA, each of which addressed a critical flaw in the original law:

• It mandates that EPA review each new chemical and make an affirmative finding as to its safety. The old law had neither mandate.
• If EPA lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the chemical in order to mitigate any unreasonable risk. The old law essentially forced EPA to allow manufacture to commence for a new chemical lacking sufficient information – such chemicals typically were simply dropped from further review and manufacture could start at the end of the review period.
• It requires EPA to consider and mitigate unreasonable risks of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution use or disposal, as well as those intended by the company providing the new chemical notice to EPA. Under the old law EPA had to confine any risk finding it did make to the specific uses identified by the company.
• It requires EPA to protect against potential risks to “potentially exposed or susceptible subpopulations,” including workers. Such a provision did not exist in the old law.
• Where EPA imposes conditions on the manufacturer of a new chemical, it must consider whether to promulgate a Significant New Use Rule (SNUR) to apply those conditions to other companies making the same chemical. It must either initiate the SNUR rulemaking or publish a statement explaining why it is not doing so.  Under the old law taking such action was entirely discretionary and, until recently, was infrequent.

In implementing these new requirements, which took effect immediately upon the law’s enactment, EPA has taken a number of actions.  Our understanding of these actions has been informed both through various conversations with companies and EPA staff, and by examination of EPA’s interim recommendations on pre-manufacture notices (PMNs) that are made publicly available here.

Support in the law for EPA’s actions to date

Based on the information available to us, EDF supports each of EPA’s actions described below, both as consistent with or required by the law and as representing sound policy and practice:

First, EPA reset the baseline 90-day clock on reviews that were already in process on the date of enactment.  Because the new requirements applied immediately to these new chemicals, that action was both appropriate and necessary.  (EPA has explained the legal basis for its decision here [see answer to question 11].)

Second, EPA has identified a number of new chemicals for which it either lacked sufficient information to “permit a reasoned evaluation” or had information that led it to make a finding that the chemical “may present an unreasonable risk.”  In such cases, EPA is proceeding, as required under section 5(e) of the new law, to impose testing or other requirements through an order, typically a consent order being negotiated with the company.  As was longstanding practice under the old law, the additional time required for testing or negotiating a consent order also typically necessitates an extension of the initial 90-day review period, which is authorized under section 5(c) of the law, or a suspension of the review period done at the request of the PMN submitter.

Third, it appears EPA has identified a number of new chemicals for which it has identified “reasonably foreseen” conditions of use that “may present an unreasonable risk.”  This finding may have been reached even where EPA did not find that the intended conditions of use identified by the company may present such risk.  Sections 5(e) and 5(f) of the law expressly require that, where EPA finds a new chemical presents or may present an unreasonable risk under its conditions of use – which is defined in the law to include both intended and reasonably foreseen circumstances (section 3(4)) – it must issue an order imposing conditions sufficient to mitigate such risk.  It appears that EPA has taken just such action, in some cases by limiting the company to its intended conditions of use – which is necessary to support the affirmative finding that the new chemical is not likely to present an unreasonable risk under its conditions of use, as required to allow manufacture to commence.

Fourth, EPA has identified a number of new chemicals the characteristics of which raise particular concern for workers, especially with regard to the potential for adverse chronic health effects associated with long-term exposures to contaminated air in the workplace.  In such cases, we understand EPA is requesting that companies conduct testing to inform its decision as to whether the chemical presents or may present, or is not likely to present, an unreasonable risk.  Based on information available to us, EDF believes this is a prudent approach.  It is also wholly consistent with the law, which provides EPA with authority to mitigate potential risks posed by new chemicals in workplaces, including where workers represent a “potentially exposed or susceptible subpopulation.”

Looking past growing pains to better incentives and renewed public confidence

EDF recognizes that these changes being implemented in EPA’s new chemicals review process, while fully consistent with and required by the new law, are resulting in development of more orders and longer review times compared to the program under the old law.  This outcome is not unexpected as EPA develops and implements new procedures and practices to meet the new mandates under the law.  We expect that EPA’s processes will become more efficient over time and allow in many cases for more expeditious reviews.

We also hope that companies will now have greater incentive both to:  1) provide EPA with more information about their new chemicals to facilitate EPA’s mandated review and safety finding; and 2) anticipate when filing new chemical notices that their chemicals may well be produced and used for purposes beyond those they initially intend once those chemicals enter commercial distribution.

Companies have noted repeatedly that they often lack knowledge of the full range of uses of chemicals they make and may have little or no control over such uses once those chemicals are being commercially distributed.  Hence it is vital – as well as mandated by the new law – that EPA consider reasonably foreseen uses of new chemicals in making the required safety findings.

Companies concerned that limitations placed on their ability to produce and use a new chemical may impede innovation or competitive position can and should incorporate a broader range of conditions of use into their new chemical notices and provide EPA with the information it will need to evaluate that broader range of conditions of use.

By acting on these strengthened incentives to provide more information and anticipate future uses, companies can better ensure that the much-needed enhanced review of the safety of new chemicals mandated by the Lautenberg Act can be achieved without impeding innovation or the ability to compete.

For too long, economic factors have dominated over the public’s right to expect that chemicals to which they may be exposed will not be allowed into use without adequate assurance of their safety.  That has undermined consumer confidence in our chemical safety system.  The public understands that the most efficient and effective stage at which to provide assurance of safety is before commercial production and use begins, rather than waiting and then having to try to mitigate risks that arise after a new chemical is embedded in commerce.

By Lindsay McCormick

Lindsay McCormick is a Project Manager.  

As promised in Tuesday’s blog post, we’ve compiled additional information on the 10 chemicals EPA selected as the first to undergo risk evaluations under the new TSCA.

Click on the image to the right to see:

• EPA’s 2014 rankings on hazard, exposure, and persistence & bioaccumulation characteristics of these chemicals in its TSCA Work Plan for Chemical Assessments;
• Examples of consumer, commercial, and industrial uses; and
• National production volume (i.e., volume produced and imported into the U.S.) for 2011 based on EPA’s 2012 Chemical Data Reporting (CDR) information. (Note the 2012 data are the latest publicly available. EPA recently completed its collection of 2016 data, but they are not yet publicly available.)

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday a bipartisan group of nine Senators who were deeply involved in passage of the Lautenberg Act wrote to President-Elect Trump’s transition team to urge that EPA under the next Administration “vigorously implement the new law.”  The Lautenberg Act amended the Toxic Substances Control Act of 1976 (TSCA) and was signed into law by President Obama on June 22, of this year.

The group went on to state that strong implementation “includes moving expeditiously to identify and address chemicals with the greatest potential impact on public health, especially those affecting vulnerable populations.  … Successful implementation of this law will also help ensure there is certainty and restore confidence in the marketplace for manufacturers, consumer product producers, and the public.”

The Senators urged that the transition team work with EPA “to communicate on critical steps that are underway and to get a full appreciation of the new law’s deadlines.  We urge that you view appointments, funding and staffing to this office with the utmost importance.  It is essential to maintain momentum during the Presidential transition and in the early months of the new Administration to ensure that this new law is successful.”

The signatories to the letter are Sens. Tom Udall (D-NM), James Inhofe (R-OK), Cory Booker (D-NJ), Shelley Moore Capito (R-WV), Tom Carper (D-DE), Mike Crapo (R-ID), Ed Markey (D-MA), Jeff Merkley (D-OR) and Sheldon Whitehouse (D-RI).

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick and Jennifer McPartland contributed to this post.

Today, in advance of the December 19, 2016 deadline specified under the new TSCA, EPA has announced the first 10 chemicals to undergo risk evaluations (see list below).

This is a very important early step called for under the Lautenberg Act, which passed Congress with overwhelming bipartisan support.  Early action by EPA was seen by stakeholders across the spectrum as essential to begin the process of restoring public and market confidence in our nation’s chemical safety system.  So EPA’s issuance of this list in advance of the statutory deadline next month is a welcome sign of timely implementation of the new law.

While not every chemical that everyone may have wanted is included among the first 10, that is because there are many more than 10 chemicals that need far greater scrutiny as to their safety.  Indeed, the longer “Work Plan Chemicals” list from which EPA drew the first 10 consists of nearly 100 chemicals that present significant potential risk.

What is most important is that EPA gets started, so that it can complete risk evaluations of the first 10 and move on to the next.  EPA now has 6 months to establish the scope of its risk evaluations for these chemicals, identifying the uses, hazards, exposure and vulnerable populations it will evaluate.  

The 10 chemicals EPA has identified clearly warrant scrutiny, as there is significant evidence both that they pose hazards to health and the environment and that exposure to them is likely or actually occurring.  For three of the 10 chemicals – TCE, methylene chloride, and NMP – EPA previously completed risk assessments for narrow uses of them.  Those assessments identified very high risks to workers and consumers from those uses, and EPA has proposed restrictions on them that are pending in OMB review (see here, here and here).  EPA’s inclusion of these three chemicals on the first-10 list indicates it intends to examine a broader range of their uses and potential exposures going forward, which is called for under the new law.

Below are the first 10 chemicals and examples of their uses and hazards.  We’ll have more information on these chemicals going forward.

  1,4-dioxane Dyes, varnishes, waxes, impurity in some industrial and consumer products

  Possible human carcinogen 1-bromopropane
(aka n-propyl bromide
or nPB) Vapor degreasing, aerosol adhesives, foam cushions, dry cleaning

  Possible human carcinogen Asbestos Insulation, brake pads, chlor-alkali industry Known human carcinogen; acute and chronic toxicity from inhalation exposures

  Carbon tetrachloride Chemical intermediate, spot removers,
solvent

  Probable human carcinogen HBCD (hexabromo
cyclododecane)* Flame retardant used in foam, electronics

  Acute aquatic toxicity Methylene chloride
(aka dichloromethane
or DCM)** Paint and coating-removal products,
automotive products,
spray paint,
adhesives

  Probable human carcinogen N-methyl pyrrolidone
(NMP)** Paint and coating-removal products,
cleaning agent, chemical intermediate

  Reproductive toxicity Pigment Violet 29 Dye used in automotive and other coatings
and plastics

  Aquatic toxicity Trichloroethylene
(TCE)** Dry cleaning, consumer, commercial, and industrial degreasers

  Known human carcinogen Tetrachloroethylene
(aka “Perc”) Dry cleaning, metals degreasing, spot
removers, wood cleaners,
shoe polish

  Probable human carcinogen

*   as part of cyclic aliphatic bromides cluster of flame retardants

** additional uses  and exposures beyond those in first risk assessments

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

It was more than a bit heartening that, even post-election, chemical industry representatives have been publicly urging that the Environmental Protection Agency’s (EPA) implementation of the new Toxic Substances Control Act (TSCA) should continue apace.

So it pains me greatly to be reading that some in industry are aggressively pressing the Office of Management and Budget (OMB) to block at least one of EPA’s proposals to restrict certain very high-risk uses of trichloroethylene (TCE), which focuses on TCE’s use in commercial vapor degreasing operations.  As reported late last week by Inside EPA (subscription required), industry representatives have asked OMB not to even allow EPA to issue its proposal for public comment, despite the fact that the industry and the rest of the public have yet to see it.

These are the first risk reduction actions EPA is proposing to take under the Lautenberg Act, which passed earlier this year with strong bipartisan support.  Industry supported the new law, saying it accepted the need to give EPA stronger authority to identify and restrict dangerous uses of chemicals in order to help restore public confidence in the nation’s chemical safety system.  So why are some now seeking to block the very first actions taken under the new law?  This type of behavior— fighting even limited steps by EPA to address even the riskiest of chemicals—is what brought about this crisis in confidence in the first place.  

Bear in mind that TCE is a very nasty chemical.  A 2013 review of thousands of scientific studies by EPA scientists concluded that TCE is carcinogenic to humans by all routes of exposure and poses additional hazards, including immunotoxicity, neurotoxicity, and adverse effects on the developing heart.  TCE’s strong link to cancer has been confirmed by the International Agency for Research on Cancer (IARC), EPA’s Integrated Risk Information System (IRIS),  the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Toxicology Program (NTP).

We’ve blogged earlier about EPA’s TCE risk assessment – the first issued by EPA’s toxics office in three decades – and its initial efforts to address the extremely high risks identified in that assessment.  Earlier this year, EPA sent two draft proposed rules to OMB that would restrict those uses of TCE that EPA found to pose excessive risks to workers and consumers:

• One, sent to OMB on July 27, is aimed at TCE’s use as a spotting agent in dry cleaning and in commercial and consumer aerosol spray degreasers.
• The other, sent to OMB on September 30, is aimed at TCE’s use in commercial vapor degreasing.

Both proposals remain under OMB review as of this writing.  And now it appears industry representatives are urging OMB to block at least the latter proposal from going forward even for public comment.

Lest there be any doubt about the need to restrict these uses, consider the breadth and magnitude of risks identified by EPA:

• Acute developmental effects: Exposures that exceed, often by large margins, the level identified as “safe” for all or most exposure scenarios for workers, bystanders and consumers.  This is the case even for low-end exposure estimates in settings that employ local exhaust ventilation.  Exceedances range from 2-170,000 times the “safe” level.
• Cancer:
  • Degreasing: Risk exceeding 1 in 10,000 for all exposure scenarios, even including low-end exposure estimates in settings that employ local exhaust ventilation.
  • Spot cleaners: Risk exceeding 1 in 10,000 for most (5 of 8) exposure scenarios, with all scenarios exceeding 1 in 1,000,000 and all but one exceeding 1 in 100,000.
• Chronic non-cancer effects:
  • Developmental, kidney, immuno, autoimmune, reproductive and neurotoxicity:
    • Degreasers: Exposures that exceed, often by large margins, the level identified as “safe” for all exposure scenarios for workers and most for bystanders.  This is the case even for low-end exposure estimates in settings that employ local exhaust ventilation.  Exceedances range from 2 to 140,000 times the “safe” level.
    • Spot cleaners: Exposures that exceed, often by large margins, the level identified as “safe” for nearly all exposure scenarios for workers and most for bystanders.  An exception is low-end exposure estimates in settings that employ local exhaust ventilation.  Exceedances range from 1.1 to 14,300 times the “safe” level.

Given the huge magnitude of these risks, EPA’s proposal to restrict these uses should be a no-brainer.  One might have hoped that industry would have accepted this, even out of its own self-interest.

If industry is serious about rebuilding the public’s trust and confidence in their chemicals and products containing them, it needs to stop attacking EPA at every turn and let it do its job.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

A key reform under the Lautenberg Act is the requirement that the Environmental Protection Agency (EPA) generate an accurate, up-to-date list of all chemicals in active commerce.  This is to be accomplished by promulgating a rule to do a full “reset” of the TSCA Inventory that distinguishes between active and inactive chemicals.  It is necessary because the 85,000 chemicals on that Inventory represent a cumulative listing of all chemicals that have been in commerce at some point since its establishment in 1979, but no doubt includes many that are not now in commerce.

I have blogged previously about why it is important that EPA and the public know how many and which chemicals are in use today in the U.S.  Among other reasons, it is essential that we understand the magnitude of the task that awaits EPA under the new TSCA, with respect to prioritization, risk evaluation, risk management, and substantiation and review of confidential business information (CBI) claims.  That has implications for the pace of the program and the resources EPA will need to do its job, which extends ultimately to reviewing the safety of all chemicals in commerce.

EDF provided EPA with our comments on what should be included in EPA’s upcoming rule establishing the Inventory reset.  Unfortunately, comments on that rule received from some in industry indicate that they are seeking to limit the Inventory reset in ways that are not allowed under the new law and are short-sighted or even counterproductive to the purpose of the reset.  I provide a critique here of three of those proposed limitations.  

Proposal to limit the Inventory reset to CDR chemicals

First, some in industry argue that EPA’s Inventory reset rule could or should start with or limit the reset to those chemicals already required to be reported under its Chemical Data Reporting (CDR) rule, which requires manufacturers to report every 4 years to EPA which chemicals they make or import, as well as other information about those chemicals.  However, the CDR reaches only a fraction of chemicals in active commerce, between 7,000 and 8,000.  That is because of two factors:  First, the CDR rule only requires companies to report chemicals they make or import in amounts at or above 25,000 pounds per reporting site per year.  Second, numerous exemptions apply that remove whole categories of chemicals (e.g., most polymers) from the reporting requirement.

All evidence points to the likelihood that the number of chemicals produced below the CDR’s 25,000-pound threshold greatly outnumbers those reported under the CDR.  Experience under the European Union’s REACH Regulation’s registration process is one such line of evidence.  To date, about 8,000 substances produced in amounts above 100 metric tons per year (220,000 pounds/yr) have been registered under REACH.  However, REACH officials expect a total of about 35,000 chemicals to be registered when REACH is fully implemented in 2018 and includes all chemicals produced in amounts exceeding 1 metric ton (2,200 pounds) per year.  Given the global nature of the chemical industry, there is every reason to expect that similar numbers will apply in the U.S.

The Lautenberg Act’s Inventory reset provision makes no allowance for EPA to impose a reporting threshold or to limit the reset to the CDR chemicals.

Here’s the provision [section 8(b)(4)(A)(i); emphasis added]:

(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

The “list published under paragraph (1)” is in fact the full TSCA Inventory.  Hence, EPA’s rule must require that manufacturers report “each chemical substance” on the full inventory that they make or import.

Now, to be clear, Congress did provide for EPA to use the latest list of CDR-reported chemicals as an interim list of active substances.  Section 8(b)(6) states (emphases added):

(6) INTERIM LIST OF ACTIVE SUBSTANCES.—Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, as the interim list of active substances for the purposes of section 6(b).

Had Congress intended the Inventory reset conducted pursuant to the rule to be limited to the CDR chemicals, it would not have included this provision allowing such chemicals to serve as the interim list until the rule is promulgated.

In sum, there is no basis for EPA’s rule to limit the Inventory reset to the CDR chemicals.

Proposal to allow exemptions from the Inventory reset

Some in industry are urging that EPA’s rule extend exemptions provided under other sections of the law to the Inventory reset.  Here again, there simply is no basis in the new law to do so.  Per section 8(b)(4)(A)(i), EPA’s rule must require manufacturers to notify EPA of each chemical substance on the list published under paragraph (1) they manufacture.  There is no mention of or allowance made for any exemptions.  This, together with no reporting threshold, is important to ensure that the Inventory reset yields a full list of all chemicals in active commerce.

Proposal to halt the Inventory reset process for a given chemical after receipt of the first notice

Some in industry are also arguing that receipt of a single notice for a given chemical as being active would suffice and that at that point “additional reports for the chemical need not be required.”

Here again, the law is clear this is not allowed. Let’s go back to the Inventory reset provision [section 8(b)(4)(A)(i); emphasis added]:

(i) IN GENERAL.—Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Clearly this provision requires each manufacturer of a substance on the Inventory to notify EPA if it is manufacturing it.  Nothing in this language allows a subset of such manufacturers to file notices.

Nor would the industry’s proposal work in practice or necessarily be desirable even to them.  Part of the notice a manufacturer must file is a reassertion of any existing claim to protect from disclosure the identity of a chemical the company wishes to maintain; see section 8(b)(4)(B)(ii).  Such CBI claims and the basis for them are, of course, specific to the company asserting the claim.  If the Inventory reset process for a chemical could stop after the first notice is received, that could well mean that only that first notifier’s CBI claim would be asserted – and even then only if that notifier had an existing claim and wished to reassert it.  Under this scenario, requests to maintain existing CBI claims originating with other manufacturers of that same chemical might well not be received by EPA.

In this context, the new law is clear that the identity of any active chemical for which no requests are received through the Inventory reset process to extend an existing CBI claim must be disclosed to the public [section 8(b)(4)(B)(iv); emphasis added]:

(B) CONFIDENTIAL CHEMICAL SUBSTANCES.—In promulgating a rule under subparagraph (A), the Administrator shall—

(iv) move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list.

I suspect that is not an outcome those in industry urging EPA to stop the process for a chemical after receipt of the first notice would be pleased with.

In sum, the new law is clear that all manufacturers must notify EPA of their active manufacture of a chemical, and that, unless any existing CBI claims are asserted at that time (and later reviewed and found to be warranted), the identity of that chemical is to be made public.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

When President Obama signed the Lautenberg Act into law in June, it marked the beginning of a new phase in the long battle to improve chemical safety. Much of the success or failure of the new law now hinges on how well it is implemented. There are both a critical need and numerous opportunities for those who have a stake in improving our chemical safety system to engage in shaping how the law will be implemented.

To that end, EDF has developed an Engagement Guide that provides an overview of some of the key provisions in the Lautenberg Act and associated opportunities for stakeholder engagement, including:

• Safety Standard and Vulnerable Subpopulations
• Science Advisory Committee on Chemicals
• Prioritizing Chemicals in Use
• Risk Evaluations of Existing Chemicals Deemed High-Priority
• First Chemicals to be Reviewed
• Restrictions on Chemicals that Present an Unreasonable Risk
• New Chemicals Entering the Market
• Transparency and Information Access
• Legal Recourses
• Preemption of State Authority

I hope you find it useful!

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday was the deadline for stakeholders to file written comments on three rules EPA is now developing, as required under the new Toxic Substances Control Act (TSCA as amended by the Lautenberg Act).  EPA is moving quickly to get input on these rules, which it intends to propose in December in order to stay on track to finalize the rules by June of next year, as mandated under the new law.

The solicitation of written comments follows public meetings EPA held on August 9, 10 and 11 to get input from stakeholders on these rules, at which dozens of stakeholders provided oral comments.  Those meetings were the first EPA public meetings since the Lautenberg Act was signed into law on June 22.

The three rules (and associated docket numbers) on which EPA solicited comments are:

• Risk-Based Prioritization Procedural Rule, which will set forth the process and criteria EPA will use to prioritize chemicals in commerce. Docket EPA-HQ-OPPT-2016-0399
• Risk Evaluation Procedural Rule, which will set forth the process EPA will use to conduct risk evaluations of high-priority and industry-requested chemicals. Docket EPA-HQ-OPPT-2016-0400
• Rule Establishing Fees for the Administration of TSCA, which will detail how EPA will collect fees from companies to defray the costs of administering core activities under the new law. Docket EPA-HQ-OPPT-2016-0401

EDF filed comments yesterday on all three rules, available here, here and here.

Several of the key recommendations from each of our comments follow.  

Prioritization

1. The prioritization rule should be procedural in nature, and the specifics of science policy issues should be left to guidance documents and policy statements.
2. The process established by the prioritization rule should include concrete steps to collect and develop information on chemicals that lack sufficient data on which to base prioritization decisions.
3. Close coordination between the prioritization and risk evaluation processes is needed to ensure deadlines are consistently met.
4. EPA prioritization decisions must apply to chemicals, not to particular uses or conditions of use.
5. A wide range of types of data should be able to be used to identify high-priority chemicals.
6. More robust and complete data are needed for low-priority designations than for high-priority designations.

Risk Evaluation

1. The risk evaluation rule should be procedural in nature, and the specifics of science policy issues should be left to guidance documents and policy statements.
2. The risk evaluation rule should further delineate the definitions of “intended, known, or reasonably foreseen” conditions of use and “potentially exposed or susceptible subpopulations.”
3. In establishing the scope of a risk evaluation, EPA should
   • provide a public comment opportunity; and
   • consider all uses of a chemical and all potentially relevant subpopulations, but have authority to choose a scope that is narrower where fully justified.

1. For uses and conditions of use included in the scope of a risk evaluation, EPA should generally assess exposure on an aggregate basis.
2. Any draft risk evaluations submitted by interested persons need to be subject to public comment, and should not determine or limit the scope of EPA’s risk evaluation.
3. The scope of industry-requested risk evaluations should be established by EPA, not the manufacturer requesting the risk evaluation.
4. Peer reviews of EPA risk evaluations need to use procedures to ensure reviewers do not have conflicts of interest.

Fees

1. EPA should assess fees in direct proportion to the level of effort the Agency will expend on the particular activity to which a fee applies. EPA should not exempt from fees certain EPA reviews or other activities that will require resources to conduct and that fall under areas of the law that are squarely within its fee authority.
2. All of the costs to EPA associated with its reviews and other activities need to be included in the baseline budget on the basis of which the overall level of fees is to be determined.
3. The level of fees required of a manufacturer requesting a risk evaluation must reflect EPA’s costs for the full risk evaluation EPA conducts.
4. EPA should not initiate industry-requested risk evaluations until it has received the applicable fees mandated to defray its costs.
5. Companies should not be allowed to pay a higher fee in order to expedite EPA’s review of its new or existing chemical.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

Today, EPA posted on its website risk determinations for four new chemicals it has reviewed under the new standards prescribed by the Lautenberg Act.  While the premanufacture notices (PMNs) for these chemicals were received by EPA prior to the June 22 signing of the new TSCA, EPA has reviewed them in the context of the new requirements.  (Unlike reviews of chemicals already in use, which may take some years to conduct, EPA reviews of new chemicals are generally to be completed within 90 days, which is why we’re already seeing these appear so soon after enactment.)

These decisions are notable in that they are the very first formal decisions EPA has made under the new law.  Based on an admittedly quick review of the decisions, I’ll offer a few observations.  

A number of positive aspects of EPA’s review and posting are apparent:

• For the first time, an affirmative safety decision has been made by EPA for these new chemicals, reflecting a central reform of new chemical reviews that is required under the new law. In each case released today, EPA’s determination is that the chemical “is not likely to present an unreasonable risk.”  (I expect EPA chose relatively “easy” cases for this debut.)
• These decisions have been made public, as required under the new law, which was a rarity under the old law.
• Summaries of the bases for the decisions have also been made public, both in the table provided on the website (see above link) and in 3-page “determination documents” for each substance. These documents provide, in one place, clear descriptions of:
  • intended, known and reasonably foreseen uses of the chemical;
  • a summary of EPA’s findings;
  • descriptions of the criteria used and results of its analysis or consideration of:
    • environmental fate
    • persistence
    • bioaccumulation potential
    • human health hazard
    • environmental hazard
    • potential exposures
    • potentially exposed or susceptible subpopulations

This, in my view, constitutes an unprecedented level of transparency for a program that has often felt like a “black box” in the past.

That’s all good news.  But there are other concerning features of the reviews that bear mention:

Confidential information. Substantial amounts of information were claimed confidential – and kept so by EPA, including:

• the identities of the companies submitting the PMNs
• the identities of the substances
• the specific uses of the substances (with one exception)

This is not atypical with PMNs, but such confidential business information (CBI) claims are now subject to a range of new requirements under the Lautenberg Act.  It is not clear the extent to which such claims were scrutinized by EPA in these cases, and as the PMNs were submitted and the claims asserted prior to the signing of the new law, it’s not clear these particular claims would have been subject to the new requirements.  Going forward, however, we will be seeking assurance that EPA is applying the new CBI requirements to applicable claims in PMNs and also reflecting them in its reviews and decision documents regarding those PMNs.

Estimated, not measured, data. Essentially all of the environmental fate, hazard and exposure information on which EPA based its decisions is predicted, not measured, and is derived using its suite of estimation models, structure-activity relationships or read-across.  Use of such information is the traditional way in which EPA has conducted reviews in the past when companies fail to provide any or adequate safety data in their PMNs (true in a large majority of cases), and it may well not be adequate going forward as the basis for EPA to make the requisite affirmative safety finding.

While they can be useful, such estimation approaches and models have significant limitations, don’t work well for some classes of chemicals (e.g., certain heavily halogenated compounds), and aren’t available or reliable for some important health endpoints (especially chronic human health effects).  Just one example is that EPA’s persistence models typically only examine a chemical’s persistence in air, water soil, and sediment, and its bioaccumulation model is based on uptake from water.  Yet some chemicals (e.g., the “Teflon chemical” PFOA) that are “passed” by those models can nonetheless persist and build up in people’s blood.

In the absence of public knowledge of the identities of the chemicals, it’s difficult if not impossible to independently judge whether sole reliance on such information was adequate in these four specific reviews.  And assuming these cases are relatively “easy ones,” they should not be viewed as representative, and the approach EPA deemed adequate here should not be viewed as precedent-setting.

A number of observers have called on companies to provide more safety information up front in their PMNs, in order to increase the likelihood of smooth reviews under the Lautenberg Act.  We would echo that call and will be watching this issue closely going forward.  In addition, the Lautenberg Act provides EPA with ready authority both to require testing in order to obtain adequate information on which to base its decisions, and to either block or condition commencement of manufacture pending receipt of that information.

Need for more than just summaries. As much as we welcome the greater transparency and extent of documentation of EPA’s review of these four cases, the determination documents EPA has provided are still only summaries and really only provide EPA’s interpretation of the information and analysis it has conducted.  The PMN review process routinely generates more detailed review documents that provide its model inputs, outputs and assumptions.  But in the past these have rarely been made public, and when they are available, they are heavily redacted due to CBI claims — in our view, overly so.

EDF urges EPA routinely to make its more detailed PMN review documents public, and to redact only information that is truly confidential.

Cursory consideration of exposure and exposed subpopulations. EPA’s reviews of exposure potential appear incomplete and insufficient, as well as its identification of potentially exposed or susceptible subpopulations.  (The law now includes an explicit requirement that EPA account for and mitigate against unreasonable risks to such subpopulations.)  In all four cases, EPA noted that exposure potential was not even estimated due to predicted low bioaccumulation and hazard potential.  Among other issues, this amplifies the concern we have over EPA’s heavy reliance on limited estimation models for bioaccumulation and hazard, when that in turn leads EPA not to further consider exposure potential.

In addition, in at least one case the basis of EPA’s identification of workers as the only potentially exposed subpopulation seems wholly inadequate.  That chemical’s intended use is listed (generically) as “plastic additive.”  This begs many questions, for example:  which plastic(s), for what uses?  Is there potential for the additive to migrate out of the plastic, which could lead to all kinds of potential exposures to a variety of subpopulations?  What about releases in post-use waste management of such plastics?

Going forward, EDF urges EPA to do a more thorough review of the exposure side of the risk equation.

So, these first decisions by EPA under the Lautenberg Act are welcome and appear to represent real progress in a number of respects.  We recognize the pressure EPA was under not to unduly extend its reviews of PMNs that had been filed prior to the law’s passage.  Going forward, however, and in dealing with less “easy” cases, EPA needs to do more to ensure and communicate that its review is based on information sufficient to make the affirmative finding the new law requires:  whether each new chemical is or is not likely to present an unreasonable risk.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

[UPDATE:  Please see additions below.  On reflection, my "got lucky" theme here may well have been a poor choice, as I certainly did not mean to imply that the spill was anything other than a nightmare for affected residents; rather, it was my attempt to again highlight the extent to which officials were flying blind at the time due to numerous systemic failures.  While the NTP study I discuss here answers some questions and I believe is cause for some relief, it did not address all concerns, leaves considerable uncertainty, and doesn't begin to undo the damage of this incident and its continuing aftermath.  Apologies to anyone who took my phrase to imply otherwise.]

Readers may recall that I blogged extensively about the January 2014 spill of chemicals into the Elk River near Charleston from tanks used to store the chemical near the river’s edge, which disrupted the drinking water supply and the lives of 300,000 residents for many weeks thereafter.

A key concern was the dearth of health data – both publicly available and otherwise – on the key chemical components of the spilled mixture, which was used to wash coal.  As I reported in a series of blog posts, despite scant data, federal and state officials rushed to establish – and then defend their establishment of – a concentration of one part per million (1 ppm) as the “safe” level of the main component, 4-methylcyclohexanemethanol (MCHM), of the spilled mixture.  I pointed to the lack of a scientific basis for that level, largely because of the lack of adequate health information.

That remained the case even after the chemical’s producer, Eastman Chemical, decided to make public its studies of the chemical that it had hidden, claiming them to constitute trade secrets.  I tried to be careful not to claim MCHM or other spilled chemicals posed health risks, but rather that the lack of safety data was highly concerning, given the widespread extent of exposure.

Among the many outcomes of the spill was an agreement by the National Toxicology Program (NTP) to undertake a thorough study of the potential health and environmental effects of MCHM and other component chemicals.  That study is now complete, and the results were released last week.  

The good news is that the public [see updates to this post] – and those federal and state officials – appear to have gotten lucky:  NTP found no evidence of adverse effects of the chemicals at the doses to which people were exposed – although some effects were seen at significantly higher doses.  NTP noted that effects were not seen at or below the 1 ppm level.

[UPDATE:  I should clarify that the NTP study did NOT address all concerns or potential exposures; it did not look, for example, at inhalation exposures, which were of concern especially during the "flushing" procedures residents were urged to follow as well as during activities such as showering; some analyses found that such exposures may have exceeded levels recommended in federal guidance; see here and here.  Considerable uncertainty remains about the actual levels of exposure people experienced, as very limited exposure information was collected.  An article by Ken Ward in the Charleston Gazette details some of the remaining concerns and still-unanswered questions.]

Lest anyone rush to conclude that the officials setting that level “got it right,” as opposed to getting lucky, NTP’s final report notes (emphasis added):

At the time of the spill, there were few toxicological studies available on which to base a drinking water screening level. The lack of any studies in developing animals and humans was a concern, because developing organisms are typically considered more susceptible than adults to the toxic effects of environmental chemicals. There was also concern about the absence of information on many chemicals that were minor components of the spill.

Upon completion of its study, NTP concluded:

The NTP studies increased our knowledge about the toxicity of MCHM and other spilled chemicals. The results from the NTP studies reduced uncertainty about the information used to develop the drinking water screening levels.

That’s good news, though it took a concerted federal effort and millions of dollars to get to this conclusion – all long after the spill occurred.

As I noted in my blogging, MCHM is no isolated incident:  Many, if not most, chemicals in widespread use lack adequate safety data.  A large part of the blame is attributable to the ineffective Toxic Substances Control Act (TSCA) of 1976, which tied EPA’s hands when it came to requiring testing and provided no mandate for EPA to review the safety of chemicals in commerce.

Happily, change is underway:  I suspect all of my readers know that TSCA has now been updated and among the changes are several that bear on chemicals like MCHM, including these features of the new law:

• It establishes a mandate to review chemicals in active commerce like MCHM, with the timing at EPA’s discretion and subject to availability of resources.
• It requires prioritization of active chemicals like MCHM, and includes storage near significant sources of drinking water as an explicit criterion.
• It provides EPA with expanded authority to require companies to safety-test their chemicals, by issuing an order rather than through a time-intensive rulemaking, and without having first to make risk or high-exposure findings.

While no panacea, the new TSCA heads us in a new direction that will reduce the likelihood of repeating debacles like that in Charleston, WV.

That also means that, over time, we won’t have to rely on getting lucky to prevent exposing the public to known or unknown chemical risks.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

As an additional resource for people delving into the new Lautenberg Act that was signed by President Obama last week, I have developed some flow charts depicting the basic processes applicable to existing chemicals already in commerce and new chemicals prior to market entry.

Comparisons are shown between the processes under the old and new laws.

A PDF version is available here; or click on the thumbnails below.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

After 30 years in Washington, maybe I should be more jaded, but today was a big day. Not only did I have the incredible honor this morning of meeting with President Obama, but it was just prior to getting to witness his signing of a bill that I think is going to make a big difference in our lives.

When I started working on and with the Toxic Substances Control Act (TSCA) some 15 years ago and began trying to help build the case for its reform, never in a million years did I contemplate such an honor, let alone being able to work so closely on and then witness the historic signing of this strong new law.

The small group that met with the President included not only people in Washington who worked for this reform but also those who have been impacted by our broken law or stand to benefit the most from the new law:  Young adults and parents of children who have had chronic diseases and conditions like cancer and autism for which there is growing concern about the contribution of chemical exposures.  

Having been in the weeds and minutiae of TSCA reform for so long, it was very moving that the President chose to meet directly with people that this whole reform effort is most about:  The millions of Americans who worry about whether the products they use are safe for them and their families, and those left to wonder whether chemical exposures are to blame for a disease or condition they or their loved ones contract.

I came to work on TSCA somewhat indirectly.  I spent a lot of the 1990s working with consumer product companies trying to develop tools their formulators could use to assess the health and environmental impacts of the chemicals they were using or considering using in their products.  Repeatedly we found that the data they needed to make better choices were almost always lacking. That’s when I started realizing that our weak chemical safety law bore much of the blame for the lack of information available in the market about most chemicals.

I also came to believe that, in part because of a broken TSCA that never required a government review of chemicals, product companies lacked incentives to ensure the safety of the chemicals in their products by developing data on potential chronic health concerns.  (Short-term concerns are typically considered because of product liability.)

One of my main hopes with the revised law is that it will shift the incentive structure companies face towards one that rewards affirmative evidence of safety instead of ignorance (a theme that goes back to EDF’s 1997 report, Toxic Ignorance). And, in turn, that the public will be better protected from the long-term health impacts of untested and unregulated chemicals.

As we all now turn to the challenging task of implementing this new law, I am optimistic that we’ve turned a corner as a nation and are embarking on a new path to better protecting the health of this and future generations. And I’m humbled to have been able to thank the President on behalf of the hundreds of friends and colleagues with whom I’ve worked on this effort over the years.

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

Those are four words that I thought I might never get to say and see over the many years I’ve worked on this.  But today, at a ceremony to be held at the Eisenhower Executive Office Building, President Obama will sign the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

The Lautenberg Act amends the core provisions of the Toxic Substances Control Act (TSCA), our nation’s main chemical safety law, for the first time since its passage 40 years ago.  Those amendments are extensive, reaching into nearly every aspect of TSCA – reflecting the need for a top-to-bottom overhaul.

I’ve already blogged recently about both how this was made possible and why it is so significant (see here and here).  And I’ve developed some resources for those wanting to understand what the Lautenberg Act does and how it changes TSCA for the better.

The path leading to today’s historic Presidential signing opened up just over 3 years ago, when two Senators who couldn’t have been more different politically – the late Sen. Lautenberg and Sen. David Vitter – came together to introduce the first bipartisan TSCA reform legislation.  At that time, I and others here at EDF had a tough decision to make:  lend our support to give momentum to a bill that we knew had serious flaws, or withhold that support – lest it give momentum to such a bill.

We took the calculated risk – and it was a big one – to support the bill for four reasons. 

First, we believed Sen. Lautenberg, our community’s longtime champion on this issue, deserved our support.  Second, the bill, despite its flaws, held the seeds of many of the reforms we sought even as it had many provisions we did not support.  Third, we were concerned that, were there to be no support from our community, the bill would be unlikely to advance and we would lose yet another opportunity to reform TSCA.  Fourth, we believed that the best way to fix the serious problems with the bill was to help get it moving through the legislative process, work diligently to find solutions to those problems that could still retain bipartisan support, and encourage the engagement of additional lawmakers to make those changes in exchange for their support for the bill.

I fully recognize and respect that others in our community chose a different approach, didn’t support EDF in our decision, and maybe still don’t.  To that, I’ll quote a song from the 1960s I still love: “Different strokes for different folks.”  There’s simply no way we would have passed this law – and this strong a law – without multiple actors taking multiple approaches to getting it done.

The path by which this new law wended its way through Congress over the past three years has been likened to climbing a very high mountain.  You can’t do it all in one climb; you can’t begin to think about doing it by yourself; and you need to establish and attain multiple base camps on the way up.  (I could torture the analogy further:  watch out for avalanches and sudden storms that can sweep you away at any moment; expect to suffer repeatedly from exhaustion and shortness of breath; don’t hurry and stick close to the ropes; and so on.)

Before I get carried away, let me close by restating something I said in a recent perspective piece:

Of course, now the real work begins—implementing the law. Which brings me to my last point: A fervent hope that stakeholders will give this new law every chance to work. … I realize it’s a tall order to expect stakeholders with strong interests in certain outcomes not to use every possible avenue to influence every step the EPA takes under the new law. But it’s vital that its implementation lead to improved public health protection as well as a restoration of public confidence, after decades of erosion of that confidence under a badly broken chemical safety system. That means the EPA needs to be given some breathing room, to get a new system up and running, and to get some points on the board early that demonstrate its ability to make decisions and take needed actions.

Meanwhile, I’ll say those four words again:  A strong new TSCA.  That sounds really great, doesn’t it?

By Richard Denison

Richard Denison, Ph.D., is a Lead Senior Scientist.

With last Tuesday’s passage by the Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576), a new TSCA is on its way to the President’s desk to be signed into law.

To assist everyone in understanding what the new law will do and how it compares to original TSCA, I have prepared two new documents:

• Want to see how TSCA now reads as amended by the Lautenberg Act: Here is a redline of TSCA based on the final bill.
• Here is a 10-page side-by-side of old vs. new TSCA, compared in 12 key issue areas.

And here are links to our earlier analyses of the bill:

•  a description of:  (a) how the Lautenberg Act amends the Toxic Substances Control Act of 1976 and (b) changes made after House and Senate bill passage to reconcile the bills;
• a description of what is and is not preempted under the Lautenberg Act; and
• Our fact sheet on the Lautenberg Act.

Enjoy!

By Richard Denison

Reproduced with permission from Daily Environment Report, 111 DEN B-1, 6/9/16, 06/09/2016. Copyright © 2016 by The Bureau of National Affairs, Inc. (800-372-1033) http:// www.bna.com

[PDF version]

CONGRESS

Now that TSCA reform has passed despite a polarized Congress, many are wondering how it came about. Richard Denison at the Environmental Defense Fund has been engaged for many years on toxics legislative reform and explores the critical junctures that opened up the opportunity to update this major environmental legislation despite multiple obstacles.  

Why Passage of Toxic Chemical Reform Is a Really Big Deal

BY RICHARD DENISON

First, the obvious: It’s the first major environmental legislation to be enacted in more than 20 years. And it’s all the more remarkable that it passed, with strong bipartisan support, in a divided Congress and at a time when most environmental issues are highly polarizing. Last month, the House passed the bicameral agreement by the overwhelming margin of 403-12. And just this week, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) came to the Senate floor by unanimous consent, passed on a voice vote and was sent the President’s desk for his signature.

While virtually every provision of the new law significantly improves on existing law, it does so by delicately balancing long-standing interests that are competing or in direct conflict. The new law is built on carefully crafted compromises, classic in the sense that no one got everything they wanted but everyone got something, and not just overall but in each major section of the law. What makes this accomplishment extraordinary is that the balance was reached, not by skirting around the most contentious issues, but by directly tackling and seeking to resolve the differences.

How was this possible?

First, it took a long time. My organization started working 20 years ago toward legislative reform of the Toxic Substances Control Act (TSCA). The first conversations on Capitol Hill that planted the seeds that grew into the Lautenberg Act took place in 2004—convened, appropriately enough, by staff for the late Sen. Frank Lautenberg (D-N.J.), who made the cause of improving chemical safety his last crusade in a long Congressional career devoted to improving public health. Those conversations yielded the first reform legislation, the Kids-Safe Chemicals Act of 2005, a 35-page “message” bill aimed primarily at demonstrating that there was interest in Congress in reforming TSCA.

Not surprisingly, that bill went nowhere. It was actively supported by health and environmental groups, and actively opposed by the chemical industry. And members of each party in Congress lined up accordingly—to the extent it got their attention at all. Nonetheless, in retrospect it was an important milestone because it began a serious conversation about both the need for reform and what reform should look like.

A series of bills built on that first one were introduced in both houses, one nearly every year from 2008 through 2013. And while they grew in length and in cosponsorship, and increasingly reflected input from a broader range of stakeholders, they too went virtually nowhere—supported only by Democrats and nongovernmental organizations (NGOs) and uniformly opposed by Republicans and industry interests.

Industry embraces reform

The second critical ingredient was a shift that began in 2009 in the chemical industry’s stance, to acknowledge the need for reform—which it termed “modernization.” That shift was spurred by years of incremental but important actions driven by state and national advocates calling on states and the market itself to restrict chemicals. These critical players stepped in to fill the void left by a failed TSCA and to respond to the rising demands from consumers and the public for safer chemicals.

Industry’s decision to come to the federal negotiating table was an acknowledgment of a growing loss of confidence in the safety of chemicals. Thereby was born a first piece of common ground: a mutual interest in a stronger federal system, for the industry as a means to restore lost confidence among the public and the marketplace, and for health, labor and environmental advocates as a means to better ensure the safety of chemicals.

That common interest fostered a host of formal and informal stakeholder dialogues, both on and off Capitol Hill, that were instrumental in delineating the issues and articulating stakeholders’ often diametrically opposed positions, but also gradually illuminating where common ground on specific issues might be found.

A pinch of political courage

All of that might still have been for naught had not a bold step been taken by a most unlikely pair of Senators: public health champion Sen. Lautenberg and Sen. David Vitter (R-La.), a staunch ally of the chemical industry. They rather hastily negotiated the first bipartisan reform bill, the Chemical Safety Improvement Act of 2013—introduced, as it turned out, less than two weeks before Lautenberg’s untimely death. That bill, flawed as it was, opened for the first time a bipartisan path forward—a critical development if there was to be any hope of actually enacting legislation in such a divided Congress.

That bill also served as the starting point for what became the Lautenberg Act. Over the next three years, an ever-enlarging group of lawmakers from both parties and both Houses engaged in both moving and improving the TSCA reform legislation.

On the Senate side, Sens. Tom Udall (D-N.M.) and Vitter and then Sen. James Inhofe (R-Okla.) managed extensive negotiations that expanded as colleagues lent their support in exchange for strengthening changes—deepening and broadening engagement that proved critical to sustaining the momentum necessary to secure passage. A significantly revised bill introduced a year ago, named in honor of Lautenberg, was further negotiated to gain more bipartisan support during committee consideration, and then again in the lead-up to final passage in December 2015, by that time attracting 60 co-sponsors and passing by unanimous voice vote. Sens. Barbara Boxer (D-Calif.), Tom Carper (D-Del.), Sheldon Whitehouse (D-R.I.), Jeff Merkley (D-Ore.), Cory Booker (D-N.J.), Ed Markey (D-Mass.) and Dick Durbin (D-Ill.) all played significant roles.

The House process was much quicker but equally bipartisan, with a bill introduced in May 2015 and passed in June of last year, by the remarkable margin of 398-1. Reps. Fred Upton (R-Mich.), Frank Pallone (D-N.J.), John Shimkus (R-Ill.) and Paul Tonko (D-N.Y.), and later, Nancy Pelosi (D-Calif.), Steny Hoyer (D-Md.), Diana DeGette (D-Colo.) and Gene Green (D-Tex.), shepherded and supported moving the bill through the House and the bicameral negotiations.

Reconciling two very different bills

Those negotiations had to reconcile a more comprehensive Senate bill with a much narrower House bill. They occupied the past several months, intensifying in recent weeks and literally running right up to the House’s filing deadline for the bill last month. The resulting bill adopts the more comprehensive approach taken by the Senate bill, while adhering to the structure and retaining much more of current TSCA—the House’s preferred approach. The final bill largely incorporates the Senate bill’s policy reforms for new chemicals, but integrates them into the structure of current law. It also includes the Senate bill’s provisions for updating the inventory of chemicals active in commerce and addressing confidential business information. A more streamlined prioritization process for existing chemicals than was in the Senate bill was agreed to. The bill’s chemical testing provision is a blend of the two original bills, and House negotiators convinced Senate negotiators to leave several sections of TSCA (e.g., exports and imports) largely untouched, as the House bill had done.

Last month, the House passed the bicameral agreement by the overwhelming margin of 403-12. And just this week, the bill came to the Senate floor by unanimous consent and was passed on an uncontested voice vote.

After 40 years, a new TSCA

The result is a new law that, while a compromise, is an enormous improvement over current law in every major respect. Specifically, the Lautenberg Act:

• Mandates safety reviews for chemicals in active commerce.
• Requires a safety finding before new chemicals are allowed on the market.
• Replaces TSCA’s burdensome safety standard— which prevented the Environmental Protection Agency even from banning asbestos—with a health-based, as opposed to cost-oriented, standard.
• Explicitly requires protection of vulnerable populations, such as children and pregnant women.
• Enhances the EPA’s authority to require testing of both new and existing chemicals.
• Sets aggressive, judicially enforceable deadlines for EPA decisions and compliance with restrictions.
• Makes more information about chemicals available, by limiting companies’ ability to claim information as confidential, and by giving states and health and environmental professionals access to confidential information they need to do their jobs.
• Requires the EPA to reduce animal testing where scientifically reliable alternatives exist that would generate equivalent or better information.
• Requires the EPA to prioritize chemicals that are persistent and bioaccumulative, and that are known human carcinogens and have high toxicity.
• Retains a significant role for states in assuring chemical safety, by grandfathering in past state actions, preserving states’ ability to take many types of actions, and providing for states to get waivers to act both before and after the EPA takes final action on a chemical.

The next phase

Of course, now the real work begins—implementing the law. Which brings me to my last point: A fervent hope that stakeholders will give this new law every chance to work. Similar to any major legislation, no one is completely happy with it. Many critical details of the law are left to the EPA to flesh out. And, for the new law to be successful, the agency will need to make far more—and far more timely—decisions about chemicals’ safety than has been the case historically. This job will be an enormous challenge for the EPA, and stakeholders no doubt will be watching closely.

I realize it’s a tall order to expect stakeholders with strong interests in certain outcomes not to use every possible avenue to influence every step the EPA takes under the new law. But it’s vital that its implementation lead to improved public health protection as well as a restoration of public confidence, after decades of erosion of that confidence under a badly broken chemical safety system. That means the EPA needs to be given some breathing room, to get a new system up and running, and to get some points on the board early that demonstrate its ability to make decisions and take needed actions.

We should take a long moment to celebrate a major and rare environmental achievement, recognize that it took sustained cooperation and compromise by a diverse set of players to make it happen, and hope that the some of that commitment to finding common ground persists as we turn to the next phase in this long journey.