Richard Denison, Ph.D., is a Senior Scientist.
As I noted in our first post on ChAMP, after getting off to a strong start in 2007, EPA's abrupt decision in 2008 to steer ChAMP in the direction of cranking out hasty risk decisions was entirely its own. Can ChAMP be put back on track?
Neither EPA's own advisory committee – which had many members from the chemical industry as well as a few environmental NGOs – nor the commitment made by the U.S. under the North American Security and Prosperity Partnership (SPP) agreement signed with Canada and Mexico in August 2007, called for such risk assessments or risk-based prioritizations.
The commitment EPA made under the SPP agreement was "to assess and initiate needed action on the over 9,000 existing chemicals produced above 25,000 lbs/yr in the United States." There was no mention of risk assessment anywhere in the agreement. Indeed, at that time, EPA had already begun to publish hazard characterizations, which, as assessments of the hazards of high production volume (HPV) chemicals – fully meet the terms of its SPP commitment.
EPA's focus on developing HPV chemical hazard characterizations was also precisely what it had committed to do when it adopted, in November 2005, the recommendations of its own National Pollution Prevention & Toxics Advisory Committee (NPPTAC). Specifically, it agreed to complete and make public such hazard characterizations on all HPV chemicals for which it had received final data sets from the HPV Challenge – some 1,200 chemicals – within four years.
How close is EPA to meeting that commitment, with only six months to go? As of today, EPA has issued only about 130 hazard characterizations covering about 315 HPV chemicals (many of the chemicals are in categories).
So EPA's rush to risk is not only resulting in flawed risk decisions that are prematurely exonerating hundreds of chemicals, as described in our earlier posts. It is also causing EPA to renege on its promise to characterize the hazards of all sponsored HPV chemicals in a timely manner – and to clearly identify gaps in the quality and completeness of the data received under its voluntary program.
In short, EPA is compromising the public's right to know about the hazards of the most widely used chemicals in U.S. commerce. That's quite ironic when you consider EPA bills the HPV Challenge and ChAMP as cornerstones of its Chemical Right to Know Initiative.
What should EPA be doing under ChAMP?
EDF is the only environmental NGO that has been willing to engage with EPA, first on the HPV Challenge and more recently on ChAMP. We served on advisory panels, participated in public meetings, carefully peer-reviewed draft assessments, filed comments and met with EPA staff repeatedly.
Even now, we are the only voice in our community arguing that the HPV data and ChAMP could provide value if it got back on track.
We have pointed out that many of the shortcomings of the HPV and ChAMP initiatives are due to EPA's limited authority under the Toxic Substances Control Act (TSCA), and we are actively working toward fundamental reform of TSCA to give EPA the tools it needs to do a better job.
But we also believe that in the interim, and despite EPA's constraints under TSCA, EPA can and should be doing a more credible and valuable job under ChAMP.
- Return the focus of ChAMP to completing high-quality hazard characterizations for HPV chemicals, rather than rushing to issue highly suspect risk characterizations based on flawed assumptions and poor-quality use and exposure information.
- For each chemical assessed, clearly identify and communicate to the public all gaps or quality concerns in available data.
- Stop assigning low-priority rankings to chemicals, especially those with data gaps in the most basic, minimum set of screening-level hazard data. As we said before, it's one thing for EPA to identify as high-hazard those chemicals where, despite the data gaps, available data demonstrate high toxicity. It's quite another for EPA to effectively exonerate chemicals as low-hazard or low-priority when not even a bare-minimum data set is available for them.
- Adopt a health-protective approach to hazard screening: Where data are uncertain, of questionable quality or equivocal, assume a hazard exists until and unless a chemical's manufacturer provides the data to show otherwise.
- Issue test rules to require that gaps in submitted data sets be filled.
- Significantly accelerate issuance of test rules for all of the unsponsored HPV Challenge chemicals, and for the hundreds of newly emerged HPV chemicals that have never been sponsored.
- For the ~4,000 medium-production volume (MPV) chemicals – which are also covered by the SPP commitment, and for which even less data are available than for HPV chemicals – focus on identifying and acting to address data needs to support more robust hazard assessments, rather than pursuing its current approach of using scientifically unsupportable extrapolations of data among loosely defined "clusters" of such chemicals.
For chemicals for which significant hazards are identified, here are some of the good recommendations that NPPTAC offered as steps EPA could take even under its current TSCA authorities, which EPA has yet to act upon (under each, I've added a few elaborations and additional thoughts of my own in brackets):
- Gather additional information on uses (e.g., by use function, category, release potential, or benefit) and exposure (to humans and/or the environment).
- [Listing such substances on the Toxics Release Inventory would be a great way to get direct exposure data. Efforts to get better use and exposure information – well beyond the data EPA got from manufacturers under its Inventory Update Rule (IUR) – could extend to downstream users of chemicals. Information on functional use would help in identifying safer substitutes within the same functional class.]
- Gather additional information on hazards to support a more in-depth characterization.
- [Our reviews of EPA's risk decisions have identified many cases where available studies raise more questions than they answer, or identify additional concerns. EPA should require further testing in such cases.]
- Identify existing risk management programs and practices. Evaluate existing Federal and State regulatory controls (e.g., occupational exposure limits).
- [Instead, in many cases EPA merely asserts the existence or effectiveness of such practices, and seems particularly averse to even suggesting that some risk management might be needed.]
- Provide information referrals or recommendations for actions to other EPA program offices or other Federal or State agencies.
- [These could include referrals to OSHA requesting action on chemicals posing high worker hazards, proposing that the Centers for Disease Control or the U.S. Geological Survey add such chemicals to their biomonitoring and surface water monitoring programs, referring chemicals to its own Design for Environment (DfE) program to assess the availability and safety of available alternatives to hazardous chemicals, and referring such chemicals to the Food and Drug Administration where they have uses or are in consumer goods that fall under its jurisdiction.]
That's more than enough to keep the EPA toxics office busy for the foreseeable future.