EDF Health

NGOs ask Senators to investigate chronic delays in OMB’s review of TSCA regulatory actions

Rachel Shaffer is a research assistant.  Richard Denison, Ph.D., is a Senior Scientist.

Last Friday afternoon, we received the discouraging news that EPA has withdrawn two draft rules it had developed under its Toxic Substances Control Act (TSCA) authority.  As discussed in our earlier blog post, these proposed rules had been kept in limbo by the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), for 1,213 and 619 days, respectively – far longer than the 90-day limit for such reviews set by Executive Order 12866.

Unfortunately, these delays are anything but unique.  OIRA’s reviews of draft rules and other actions now routinely exceed by large margins their mandated deadlines.  Our examination of EPA’s TSCA regulatory agenda over the past several years reveals just how extensive OIRA’s “rulemaking purgatory” has become.  

Since 2009, a total of 33 TSCA-related notices or proposed or final regulatory actions have been submitted to OIRA:

  • Eighteen submissions were proposed or final rules subject to a 90-calendar-day deadline.  Reviews of only six of these rules were completed within this deadline; on average, they have been held at OIRA for over 300 days.
  • The other 15 were advance notices of proposed rulemakings or other notices subject to a 10-working-day deadline.  Of these notices, only one was completed within this deadline; on average, they were kept under review by OIRA for over 70 working days.

Today, EDF, Earthjustice, Union of Concerned Scientists, and League of Conservation Voters sent a letter documenting these delays and expressing our serious concerns to Senator Richard Blumenthal (D-CT) and Senator Orrin Hatch (R-UT), Chairman and Ranking Member, respectively, of the Senate Judiciary Committee’s Subcommittee on Oversight, Federal Rights, and Agency Action.  Our letter emphasized that such delays both prevent the public from providing input in the rulemaking process and limit EPA’s already constrained ability to obtain and share basic safety information on chemicals under TSCA.

Our letter was sent in response to an August 1, 2013, hearing held by that subcommittee, titled Justice Delayed: The Human Cost of Regulatory Paralysis, which began a much-needed discussion of the real-world impact of OIRA’s protracted review of proposed regulations.  We urged a further investigation into the causes and consequences of this too-hidden obstruction of the long-established rulemaking process. 

You can read our letter here, and stay tuned for updates in the coming months.

 

Posted in Health policy, Regulation / Tagged , , | Comments are closed

Stymied at every turn: EPA withdraws two draft TSCA proposals in the face of endless delay at OMB

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

The Environmental Protection Agency (EPA) has withdrawn two draft rules it had developed under authority of the Toxic Substances Control Act (TSCA).  EPA originally sent the proposed rules to the White House for its review way back in 2010 and 2011. 

Despite a clear requirement that White House reviews of draft proposed rules be completed within 90 days, the Office of Information and Regulatory Affairs (OIRA) [which is part of the Office of Management and Budget, OMB] sat on these two draft proposals for 1,213 and 619 days, respectively.  Faced presumably with the reality that OIRA was never going to let EPA even propose the rules for public comment, EPA decided to withdraw them.  Read More »

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EDF comments at EPA workshop on applying systematic review methodology to IRIS assessments

Rachel Shaffer is a research assistant.

Lately, much of the attention of the environmental health community has been focused on Capitol Hill and the Lautenberg-Vitter chemical safety reform bill that would amend the antiquated Toxic Substances Control Act (TSCA). Yet significant – if somewhat esoteric – developments are underway at EPA that will also have major impacts on how the safety of chemicals is assessed.  EPA has been implementing improvements to its Integrated Risk Information System, commonly known as “IRIS.” The purpose of the IRIS program is to evaluate information on the effects of potential exposures to environmental substances and provide health hazard assessments, which are then used to support regulatory decisions across the agency.  And while it isn’t directly affected by TSCA or its reform, IRIS provides both indirect and direct support to the office at EPA that does administer TSCA.  

In other words, what happens in IRIS doesn’t stay in IRIS.

So… what’s IRIS up to? Read More »

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Senate hearing builds momentum for improving and moving the Chemical Safety Improvement Act

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

Yesterday’s mega-hearing (19 witnesses, 5+ hours!) on the Toxic Substances Control Act (TSCA), held by the Senate Committee on Environment and Public Works (EPW), lent new urgency to the need for advancing long-overdue reform of this flawed and outmoded law.  And it opened a promising new phase in the long effort to get reform legislation that would protect public health through the Committee and to the Senate floor.

The hearing provided a formal opportunity for witnesses to discuss strengths as well as many of the concerns with the Chemical Safety Improvement Act (CSIA), S. 1009, the bipartisan bill authored by the late Senator Frank Lautenberg and Senator David Vitter that now has 25 Republican and Democratic cosponsors.  Notably, despite the concerns, witness after witness called on the Committee (10 members of which attended the hearing) to work to improve this bill. 

There seemed to be a remarkable level of agreement (though certainly not consensus) among both witnesses and members on several points: 

  • First, the political opening created by the introduction of CSIA represents the best chance we’ve seen in a long time to fix TSCA, with the bill serving as the starting point for the Committee.
  • Second, the compromise bill has significant flaws that need to be addressed. 
  • Third, there is a willingness on all sides to address these concerns with the current bill, and to work to keep it bipartisan. 
  • And finally, needed fixes can and should be made as the bill is taken up and advanced by the Committee.

I’ll have more to say in future posts about the concerns we and others have with the bill and how we think they can be addressed while keeping the forward momentum that was on display today. 

That won’t be easy, but as my colleague, Daniel Rosenberg of NRDC, in his testimony yesterday, brilliantly summed up the point we’re at now:  “This is no time to throw up our hands, but to roll up our sleeves.”

 

Posted in Health policy, TSCA reform / Comments are closed

Reality check on TSCA reform legislation

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

[NOTE:  This post was mostly written before Monday’s sad news of the death of Senator Lautenberg.  I have decided to post it now, both out of admiration for his steadfast determination to advance meaningful reform of the Toxic Substances Control Act even in a tough political environment, and to clarify and elaborate on EDF’s position supporting the introduction of the new legislation.]

Since the May 22 introduction of the bipartisan Chemical Safety Improvement Act of 2013 (S. 1009), co-sponsored by the late Senator Lautenberg (D-NJ) and Senator Vitter (R-LA) and 19 of their Senate colleagues, stakeholders have offered various reactions, ranging from strong support to unqualified condemnation.

Among the latter are those who lament – and list – all that is “missing” or has been “lost” from Senator Lautenberg’s earlier bill, the Safe Chemicals Act.  That’s the legislation that has been introduced in various forms in each of the last five Congresses, going back all the way to 2005. EDF and I personally were intimately involved in that legislation and worked hard to pass it all along the way.

But now in 2013 we need to face some tough facts:  Despite best efforts, that legislation was unable to garner support from a single Republican member of Congress, and never got further than a Senate committee’s approval on a strictly party-line vote.  That means there is simply no basis for talking about what has been “lost” from the current bipartisan legislation – for the simple reason that you can’t lose what you never had.

In their rush to condemn the new bill (“if the chemical industry supports it, it must be bad”) and fault it for failing to channel the Safe Chemicals Act, these stakeholders also rush past what should be the real test of the legislation:  How it compares to the status quo, the Toxic Substances Control Act of 1976 (TSCA).

As an editorial that ran this past weekend in the New Jersey Star-Ledger put it [my emphasis]: 

For the first time in 17 years, Congress has a real chance to pass a major environmental law. … [T]his is a breakthrough bill that deserves our support.  Its flaws can be fixed, and it has opened up a path to reform that never existed before.  As written, this compromise would be a substantial improvement over the status quo.

Just consider the alternative: a broken law that leaves EPA with no power to do its job, and only a handful of states trying to solve a serious national problem.

The legislation is clearly a compromise, one struck in part by focusing on amending the core provisions of TSCA.  That means it does not include a number of provisions – which I have strongly supported – that would expand the scope and approach of the current law:  For example, giving EPA the authority to address “hot spots” – geographic areas where residents face disproportionately high chemical exposures; and to require immediate reductions in exposure to chemicals we already know to be dangerous, such as so-called PBTs (persistent, bioaccumulative and toxic chemicals).  If they are not included in the legislation, other ways will need to be found to advance these critical objectives.

And even within its narrower scope, the legislation has flaws that need to and can be addressed as it advances through the legislative process.  A more predictable and accountable process for reviewing and acting on chemical risks is needed, and any pre-emption of state authority should be narrowed considerably and in a manner that preserves the rights of states to act until and unless EPA takes final action on a chemical.

But what is noteworthy about the new legislation – and is ignored by its detractors – is how it directly addresses the major flaws of TSCA that have been repeatedly identified by experts.  I am attaching a more detailed side-by-side that identifies these fixes as well as some trade-offs.  Here are some highlights:

  • Mandates safety reviews for all chemicals already in commerce:  When TSCA passed in 1976, it grandfathered in some 62,000 chemicals already in commerce, and gave EPA no mandate to review them for safety.  As a corollary, it falsely equated a lack of any safety data on the great majority of those chemicals with a lack of risk.

The Chemical Safety Improvement Act for the first time would require EPA to review the safety of all chemicals in active commerce.  And it makes a lack of safety data a basis for designating a chemical high-priority, which triggers EPA’s authority to require testing and a mandate to conduct a formal safety assessment and safety determination for the chemical.

  • Fixes TSCA’s “unreasonable risk” standard: TSCA’s “unreasonable risk” cost-benefit standard is widely regarded to have failed for two main reasons.  First, it blurs together what should be two distinct decisions:  a science-based decision as to whether a chemical poses a significant risk; and a risk management decision as to how to address such risks where they are found.  Second, it forces EPA to engage in paralysis-by-analysis by requiring it to prove that any action it proposes to take is the “least burdensome” of all possible options.

The Chemical Safety Improvement Act would fix both problems:  It redefines the “unreasonable risk” standard as one “based solely on considerations of risk to human health and the environment;”  consideration of costs and benefits is relegated to a separate risk management stage.  And it strikes the paralyzing “least burdensome” provision.

  • Requires affirmative safety decision before market entry for new chemicals:  Under TSCA, new chemicals undergo a cursory pre-manufacture review, and no affirmative safety decision is required before they can enter the market.  And in the review, the burden is on EPA to find a concern – hard to do when safety data are not required – in order to halt, slow or limit market entry.

The Chemical Safety Improvement Act for the first time would require EPA to make an affirmative finding of likely safety as a condition for the manufacture of a new chemical to commence.  And while EPA still could not directly require safety testing of new chemicals, it could suspend its review pending submission of needed data, or impose conditions needed to provide the requisite assurance of likely safety in the absence of such data.

  • Allows EPA to require testing by issuing orders:  Under TSCA, EPA must promulgate a regulation in order to require a company to conduct safety testing of a chemical it makes or uses.  This process is resource-intensive and can take many years.  Moreover, to require testing, EPA has to show potential risk or high exposure – a Catch-22, given that testing would typically be the way EPA would get the data needed to make such findings!

The Chemical Safety Improvement Act authorizes EPA to issue orders to require testing.  Using orders avoids the onerous rulemaking process and subsequent court challenges.  Moreover, while EPA must justify why it is using an order rather than a rule or consent agreement, it does not need to make risk findings to order testing of a chemical.

As one would expect in a compromise bill, each of these provisions also has its drawbacks (some of these are noted in the more detailed side-by-side).  But there is no question that, in each area of EPA activity and authority under TSCA, the new bill would be significantly better than the status quo.

That’s why EDF supports the introduction of this bill and will work toward its improvement and passage.  Which brings me back to my first point:  The strong bipartisan support for this bill, in contrast to the Safe Chemicals Act, means that it could actually be enacted into law

That would let EPA get started on the huge task of undoing the damage that nearly four decades of inaction under TSCA have brought about.

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EDF statement on the passing of Senator Frank Lautenberg

In Memoriam: Sen. Frank Lautenberg (D-NJ)

“We at EDF join in mourning today’s death of Sen. Frank Lautenberg.

“Over his long career, Frank Lautenberg was a tireless advocate for protecting America’s health and environment. As a member of the Senate Environment and Public Works Committee, he helped pass laws that have made our air and water cleaner, promoted clean energy and made our families healthier.

“EDF had the honor of working with him many times over the years, most recently on one of his top priorities — a bipartisan effort to protect Americans from the toxic chemicals they encounter every day.

“Sen. Lautenberg will be remembered as a passionate and principled statesmen who inspired all who worked with him. We will miss him dearly.”

Fred Krupp, president of EDF

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