Chemical safety reviews that take place behind closed doors, and which rely on old data and unproven methods, aren’t exactly a role model for sound science. And, they certainly don’t stand out as the kind of solid foundation on which, you would think, the most advanced country in the world would want to base its regulatory decisions. But, that just about sums up what happened when the Consumer Product Safety Commission (CPSC) proposed a rule recently on phthalate plasticizers. Unfortunately, the CPSC rubber-stamped policy recommendations from an advisory panel which, it would later become clear, didn’t exactly live up to the expectations of sound science. And that’s putting it lightly.
This regulatory process began in 2008 when Congress mandated a review of the safety of phthalates in children’s toys and child care articles by asking that a scientific panel, the Chronic Hazard Advisory Panel (CHAP), consider “likely exposures” and the “most recent, best available” scientific data in order to make a recommendation to CPSC about whether or not temporary bans, among other things, should be made permanent. At this time, the phthalate plasticizer DINP was temporarily banned at concentrations greater than 0.1 percent from children’s toys that could be placed in the mouth and child care articles.
Yet the CHAP’s review – not finalized until July 2014 – fell short of its mandate. The report was never subjected to a public peer review process, which resulted in the report being finalized despite a number of scientific flaws that could have been uncovered – and addressed – through a public review. CPSC’s failure to subject the CHAP report to public comments allowed for the agency’s staff to “rubber stamp” the CHAP’s recommendations to ban the phthalate DINP in children’s toys, despite the fact that DINP has been reviewed over the last 15 years by several scientific and regulatory bodies, which found that the very low levels to which people are typically exposed are unlikely to cause health effects.
A review of the CHAP report by internationally-recognized subject matter expert scientists coordinated by ToxStrategies, Inc. for ACC, raised significant concerns about the CHAP report and particularly its basis for federal rulemaking. Dr. Douglas L. Weed, M.D., M.P.H., Ph.D. states:
[t]he CHAP report is not a systematic review of the available scientific evidence and, as such, is of questionable reliability and validity, lacking in the objectivity and transparency generally recognized as critical by the scientific community. The credibility of the recommendations in this report [is] therefore questionable, given that they are not ‘evidence-based’ as the co-chair of the committee, Dr. Hauser, recognized and mentioned in a separate review published in the peer-reviewed literature (Braun et al., 2013).
In a hearing about the CHAP’s recommendations, CPSC Commissioner Ann Marie Buerkle questioned CPSC staff’s commitment as a “data-driven” agency after it recommended the proposed rule based on the CHAP’s analysis of old data. Three additional data sets were available that were not only more recent than what the CHAP used, but also show a marked decrease in overall phthalate exposure. The Commissioner asked, “Has the CPSC ever before knowingly proposed a regulation that is based on data that is this far out of date?”
The CHAP used this old data to carry out a cumulative risk assessment – an attempt to analyze, characterize and quantify the combined risks to health or the environment from multiple chemicals. Cumulative risk assessment should not be the basis of a regulatory decision to ban a chemical if it is based on old data. ACC raised concerns about CPSC’s use of the CHAP’s cumulative risk assessment early in the process with numerous letters to the agency, but, CPSC moved forward with their approach anyway.
Congressman Joe Barton weighed in last October raising concerns about the Commission’s reliance on the CHAP’s cumulative risk assessment. In particular, he noted “the science of cumulative risk assessment is in its infancy and has many uncertainties.” Barton wrote that banning DINP “based solely on its negligible contribution to a cumulative risk framework goes beyond the intent of the statute” and that the “CHAP’s cumulative risk evaluation could set a dangerous scientific precedent since it does not base the assessment on the most recent or relevant scientific data.”
Even EPA, a federal agency responsible for chemical assessments, put out a formal, public request for help to develop methods on how to do a cumulative risk assessment. If EPA is willing to ask for help from the public to use this chemical assessment tool, shouldn’t CPSC also be seeking public input before issuing a regulation?
Given the concerns raised by some CPSC Commissioners themselves, a number of widely-respected scientists, Members of Congress, ACC and our member companies, CPSC should not let the public concerns about the proposed regulation go unanswered.
In response to recent scientific criticism of the rule, CPSC Chairman Kaye said, “This is a critically important rulemaking, and we are determined to follow the law and to get it right, for the sake of consumer safety and the businesses impacted.”
We agree. That’s why we urge Chairman Kaye to not issue a final rule until the Agency has considered all the scientific concerns with the CHAP report, re-analyzed the cumulative risk of phthalates using the most-recently available data and seeks public comment on that analysis.