Following the report by the Consumer Product Safety Commission’s (CPSC) Chronic Hazard Advisory Panel (CHAP) on Phthalates on the 18 July, the American Chemistry Council (ACC) expressed its concerns about the unfollowed steps by CPSC to ensure the integrity of the independent review process.
No rulemaking should commence without public comment
WASHINGTON (July 19, 2014) – The American Chemistry Council expressed serious concerns today about the report released by the Consumer Product Safety Commission’s (CPSC) Chronic Hazard Advisory Panel (CHAP) on Phthalates. Instead of being subject to an open, public comment period in accordance with guidelines set forth by the Office of Management and Budget (OMB), the CHAP report was only subjected to a closed-door peer review. The report should not be used as the basis for a Proposed Rule until after the CPSC seeks and considers public comments on the report.
“The CPSC’s flawed process is setting an alarming precedent that has broad and serious implications across multiple agencies,” said ACC President and CEO Cal Dooley. “The CPSC should not use the CHAP Report on Phthalates as a basis for regulatory actions or agency reviews until the Commission seeks public comment on the CHAP report.”
CPSC did not follow several steps outlined in OMB guidelines that are needed to ensure the integrity of the independent review process, including:
- The peer review process was not managed by an entity that was independent of the group that oversaw the CHAP
- The CPSC did not make a draft report available for public comment
- The CPSC did not hold a public meeting where public comments could have been presented to the peer reviewers; and
- Absent public input, the peer reviewers had no opportunity to consider and respond to public comments.
OMB guidelines for the peer review of “highly influential scientific assessments” were established to enhance the peer review of government science documents and to improve the quality and credibility of information upon which policy decisions are based.
“A federal regulation that will have a significant impact on the commercial marketplace should not rely on unproven, novel and newly-formulated scientific approaches unless they have been appropriately peer reviewed. This is the first time a federal agency has tried to examine, characterize and quantify the combined adverse effects on human health or ecologic resources from multiple chemical stressors. Since this will affect the approach of other federal agencies, any recommendations from the CHAP should be subject to the highest level of public scrutiny, including broad scientific review, before they are used as a basis for CPSC rulemaking,” said Dooley.
According to data collected by the U.S. Centers for Disease Control and Prevention, exposure to high phthalates, such as DINP and DIDP, in the general population is 100 to 1,000 times lower than the levels established as safe by government regulatory bodies.
Phthalates have been safely used in products for more than 50 years to enhance durability, flexibility and performance. Phthalates are primarily used to make polyvinyl chloride (PVC or vinyl) flexible and are used in hundreds of products in our homes, hospitals, cars and businesses.
Phthalates are some of the most tested substances in commerce and the scientific data about their safety has been thoroughly reviewed by multiple government agencies in the United States, Europe and Australia, including the CPSC. Regulatory reviews affirming the safety of high phthalates include:
- In 2001, CPSC conducted a CHAP on the phthalate DINP affirming its safety in consumer products. In 2002, 2003 and 2007, the CPSC reaffirmed the safety of DINP in consumer products. And, in 2003, the European Union (EU) risk assessment reports on both DINP and DIDP concluded that current uses in applications such as PVC and polymers are not expected to pose a risk to human health or the environment, including sensitive populations/children.
- In 2012, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) of the Australian Government Department of Health and Ageing finalized the Priority Existing Chemical Assessment Report (PEC No. 35) on DINP finding that current exposures to DINP do not indicate a health concern for children, even at the highest exposure levels considered.
- In 2014, the European Commission aligned with the main conclusions presented in August 2013 by the European Chemicals Agency (ECHA), including that “no further risk management measures are needed to reduce the exposure” of adults and children to DINP and DIDP.