American Chemistry Council Identifies Serious Deficiencies in EPA's HPV Rulemaking
SELECTED QUOTES FROM ACC's COMMENTS
"the HPV Chemical Challenge Program is truly unique, and we hope it represents a new approach that EPA and the businesses it regulates can use and build upon in the future. The Council and its members support the Challenge Program..."
"While we support the voluntary HPV Challenge Program, we also offer constructive comments and suggestions here for improving this particular proposal."
"One of our principle concerns throughout this effort has been that EPA or others will confuse hazard data or assessments with risk, and immediately seek to initiate inappropriate or unnecessary risk management or chemical controls without providing a real opportunity to put identified hazards in a risk context. EPA should describe at the first opportunity precisely what steps it will take to prevent this from occurring.""We strongly support development of risk-based activities and programs that consider and build on the information provided under the HPV Challenge Program. ... To the best of our knowledge, the Agency has not yet articulated an overall approach to risk assessment..."
"Clearly, EPA anticipates receiving various types of use and exposure information. However, at this point it appears that the Agency has not thought strategically about how it will manage or use the information that will be submitted. There has even been resistance among some staff to receiving this information since it falls outside of the original scope of the Challenge Program. We urge the Agency to ensure that its staff develops a consistent position on this issue."
"After reviewing EPA's Economic Analysis of this proposed rule, we are concerned that it does not adequately characterize the scope and scale of EPA's testing initiative.
First, the proposed test rule covers only a subset of chemicals potentially subject to HPV testing requirements under TSCA section 4. EPA has identified approximately 2,800 chemicals as candidates for evaluation under the HPV Challenge Program (65 Fed. Reg. 81664). Sponsors have come forward thus far for approximately 2,155 of these compounds, leaving roughly 400 to 450 test rule candidates, after low priority chemicals are subtracted. Though EPA estimates the cost of the proposed test rule at between $268,000 to $283,000 per chemical, we believe the average cost of testing (including administrative costs) likely will be considerably higher. Thus, at the end of the day, we believe the full cost of this testing initiative, not including chemicals sponsored under the HPV Challenge Program, could be as high as two hundred million dollars - an amount far above the costs projected by EPA for the 37 chemicals included in this initial proposed test rule.
Second, for purposes of its economic analysis, we believe EPA should have considered all HPV chemicals potentially subject to the testing requirements in this proposed rule as a single group, as we have done in the proceeding paragraph. ...it is generally agreed that dividing an economically significant or major rule into a collection of more manageable parts does not fundamentally alter its economic significance or major character. Therefore, we believe EPA should have aggregated all HPV test rules for purposes of its economic analysis.
ACC stands ready to assist EPA with the gathering of reliable information to support its economic analyses."