EPA Limits TSCA CBI Protection To "Promote Public Understanding".

Posted on June 1, 2010 by Reed Rubinstein

The EPA has just issued a Federal Register notice stating it will deny Confidential Business Information (CBI) claims for the identity of chemicals in health and safety studies filed under the Toxic Substances Control Act (TSCA), unless the chemical identity explicitly contains “process information” or discloses “mixture information.”  This follows on EPA's January announcement that it will generally deny confidentiality claims for the chemical identity in TSCA Section 8(e) reporting for chemicals already listed on the public portion of the TSCA Inventory.  

EPA's actions to limit TSCA CBI protection are consistent with the agency's stated policy of pushing TSCA authorities beyond traditional limits. The agency's legal justification for this action is thin.  However, the policy goal is clear: "EPA believes these actions will make more health and safety information available to the public and support an important mission of the Agency to promote public understanding of the potential risks posed by chemical substances in commerce."

The Notice may be found at 75 Fed. Reg. 29755.

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TSCA Draft Is Out - Radical Changes May Be Coming

Posted on April 15, 2010 by Reed Rubinstein

Sen. Frank Lautenberg (D.N.J) has introduced a bill to comprehensively reform the Toxic Substance Control Act of 1976 (TSCA).  Lautenberg's Bill is titled the Safe Chemicals Act of 2010.  The Bill is 169 pages long and demands careful analysis.  However, on a first reading it appears radical and impractical changes are being proposed.  For example: 

  • The Bill discards TSCA's risk-based approach for the European "precautionary principle."   The Bill states all chemicals "[must] meet a risk-based safety standard that protects vulnerable and affected populations and the environment" and that companies "at all times, bear the burden of proving of proving" compliance with the "applicable safety standard."  
  • The "safety standard" is "reasonable certainty of no harm," which in turn is defined as "a negligible risk of any adverse effect on the general population or a vulnerable population."  The term "negligible risk" is not defined.  "All" chemical substances in commerce must  meet this standard.  
  • On the one hand, the Bill requires every safety standard compliance determination to be "supported by an assessment of risk conducted by an [EPA] employee or contractor..."  On the other hand, no risk assessment is required to deny compliance certification.  
  • The Bill grants EPA  total and unfettered discretion.  It explicitly (and likely illegally) exempts EPA's determination that a company has failed to prove "safety" from judicial review.  EPA is judge, jury, and executioner.
  • The Bill does not preempt more restrictive State requirements.
  • The Bill expands EPA control over nanomaterials by doing away with the "molecular identity" test.
  • The Bill does away with business confidentiality,  requiring all TSCA-related studies must be made public as part of a "registry of all health- and safety-related studies" and mandating disclosure to EPA "and the public...the sources of any funding used for the conduct or publication of the study received by the researchers who conducted the study."  

The Bill needs substantial work.  To begin with, it is poorly drafted.  Key, threshold terms are undefined (e.g., the "safety standard" is "negligible risk" - what on earth is this?), and there is a distressing lack of attention paid to the practical impact of its more radical and far-reaching provisions (e.g. has anyone out there considered the practical difficulties of requiring "all chemicals in commerce" to receive EPA approval while at the same time providing only those chemicals for which EPA has completed a formal risk assessment may be?).    

The good news is that Congressmen Henry Waxman and Bobby Rush have said they plan to introduce a "discussion draft" and conduct "stakeholder outreach" before introducing a formal House Bill.   Also, Congress is occupied with other things at the moment (Supreme Court nominations, the economy, the energy bill, the November elections, etc.).  Therefore, there is reason to hope the more problematic provisions of the "Safe Chemicals Act of 2010" will be reconsidered and recast as the legislative process moves forward. 
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Is EPA Going Its Own Way On Nanotech?

Posted on January 28, 2010 by Reed Rubinstein

As I noted here, EPA's leadership has targeted the nanotechnology industry for regulation.  The Agency's December Action Initiation List reflects this, stating EPA is developing a significant new use rule under TSCA section 5(a)(2) "for nanoscale materials."  The rule will require "persons who intend to manufacture, import, or process" nanomaterials to "notify EPA at least 90 days before commencing that activity" so EPA may "prohibit or limit that activity before it occurs" to prevent "unreasonable risk to human health or the environment." 

EPA's intentions, particularly given the massive methodological and data quality problems of nanomaterial risk assessment, need to be better understood.  Inter-agency coordination between EPA and the rest of the Federal Government on nanotechnology regulation should be a priority, yet it seems EPA is moving forward without substantive consultation.  As a first step, the industry should request more transparency from the Agency, especially with respect to the data it relies on to support this regulatory initiative.     

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