Tomorrow, the Consumer Product Safety Commission (CPSC) will vote to ban the use of several toxic chemicals—that are part of a category of chemicals known as phthalates (“thal-ates”)—from toys and child care articles such as teethers, pacifiers and sippy cups.
When the CPSC votes, as I believe it will, to finalize the proposed ban on a handful of phthalates from toys and child care articles, it will be an important advance in efforts to protect children from toxic chemicals in their homes, as well as the broader effort to shift the marketplace away from acceptance of toxic chemicals in products, our homes, our schools, our workplaces and our communities. If the Commission votes to support the final rule, it will deserve credit and appreciation for fulfilling the mandate of Congress to protect children from toxic phthalates.
But that may not be the end of this story. Exxon and other chemical manufacturers may sue to overturn the final rule, and Exxon is doubtless already running to its allies in Congress to reverse the CPSC’s action, despite the Commission’s having done exactly what Congress itself mandated in the Consumer Product Safety Improvement Act (CPSIA). In 2008, the vote for the law restricting phthalates in children’s products was 424-1 in the House, and 89-3 in the Senate. Congress voted almost unanimously to remove toxic chemicals like lead and phthalates—developmental and reproductive toxins—from children’s products. Whether our current Congress is prepared to resist Exxon and other chemical manufacturers to protect children from toxic chemicals in toys and teething rings remains to be seen.
Background: The law’s requirements, the painstaking case for regulation, and industry’s delay game
The CPSC’s vote this week—formally on whether to finalize a rule proposed in December 2014—is the culmination of a nearly decade-long process. That process began in 2008, when Congress overwhelmingly passed (and President George W. Bush signed) the Consumer Product Safety Improvement Act, to, among other things, strengthen the authority of the CPSC to address threats to consumers from both lead and phthalates. The law permanently banned the use of three phthalates in toys and children’s products (DEHP, DBP, BBP). In addition, it temporarily banned three additional phthalates pending investigation of an expert panel to be appointed by the CPSC (the panel is known as a Chronic Hazard Advisory Panel, or CHAP). Finally, Congress mandated that the expert panel 1) consider the potential health effects of phthalates and phthalate alternatives, both as individual chemicals and in combination with the other chemicals in the phthalates category (cumulative risk), and 2) recommend to the Commission whether to ban additional phthalates (or phthalate alternatives) from toys and children’s products.
The CPSC’s expert panel and those who reviewed the panel’s work were nominated by the National Academy of Sciences and were screened for conflicts of interest. The panel followed a transparent and objective process; it held seven public meetings and eight public teleconferences, as well as multiple rounds of public comment. In response, the panel received a truckload of input from the chemical manufacturers defending its toxic chemicals and some information from public interest groups like ours that outlined the public health impacts. The expert panel finally issued its peer-reviewed report in July 2014, recommending that CPSC ban five phthalates—one of the phthalates that had been banned on an interim basis by Congress (DINP) and four others (DIBP, DPENP, DHEXP and DCHP).
The expert panel focused its cumulative risk analysis on the potential effects of phthalates on male reproductive development and their potential to cause “phthalate syndrome” which includes several different adverse effects identified in lab animals including: reduced testosterone synthesis, undescended testes, testicular atrophy, and genital malformation. The proposed rule states that “the CHAP found that certain phthalates…cause adverse effects on the developing male reproductive tract. The CHAP determined that these phthalates act in a cumulative fashion.” As CPSC staff noted in its summary of the expert panel’s report: “Although the male fetus is considered the most sensitive life stage to [male reproductive developmental effects], phthalates also cause effects at all life stages, including adulthood.” While the panel found the strongest evidence of harm for male reproductive health effects, the expert panel also found that some phthalates affect critical organs and systems including liver, kidney, immune, and thyroid function.
After reviewing the CHAP’s recommendations, the CPSC’s staff then made a recommendation to the five CPSC Commissioners, agreeing with the expert panel’s recommendations. This recommendation was put forward as a proposed rule issued for public comment in December 2014. Although the law required the CPSC to issue a final rule within 180 days of receiving the final report from the expert panel, the process of issuing a final rule stretched well-past the legal deadline. Finally, in December 2016, NRDC, Breast Cancer Prevention Partners, and Environmental Justice Health Alliance sued to compel the CPSC to finalize a phthalates rule. The case was settled with the CPSC agreeing to take a final vote on a phthalates rule by October 18, 2017, (and to send the rule to the Federal Register for publication within a week of the vote). The settlement did not address the content of the final CPSC rule, only that a rule would be finalized by this date.
The CPSC’s staff recently made a final recommendation to the Commissioners to finalize the rule, largely as proposed, but with a slight expansion of the scope of the ban proposed for DINP to include all children’s toys and child care articles, and not just toys that can be placed in a child’s mouth. Last week, the CPSC staff briefed the Commissioners on their recommendation. The briefing, and the materials that the CPSC staff issued in support of their recommendation to the Commissioners demonstrate how difficult it is to restrict or ban toxic chemicals—even those that are reproductive toxins found in toys and other children’s products. The chemical manufacturing industry is ready, willing and able to spend whatever it takes to deploy lawyers, consultants and scientists-for-hire to pressure regulators not to take action to protect the public. In the case of phthalates, the major industry player has been Exxon, the largest manufacturer of phthalates.
The CPSC staff briefing and accompanying materials also demonstrate how well prepared the staff are; they addressed every single issue and objection raised by the chemical industry. In particular, the 150+ page document responding to public comments (most of which were from the chemical industry) is a study of an overworked and under-resourced staff working to painstakingly address every bogus argument that creative industry lawyers and consultants could come up with. The chemical industry loves to attack government scientists and chemical assessment programs of “cherry-picking studies” and ignoring the “weight of the evidence” regarding potential harm of a chemical, when in reality those are the preferred methods of the industry itself, as is illustrated in the CPSC staff’s response to industry comments. As just one example, industry commenters pointed to two or three small studies of marmosets to argue that primates (and therefore humans) are not harmed by phthalates; staff responded that the marmoset study was publicly reviewed by the expert panel and both the panel and the study author himself agreed that the marmoset study was preliminary and statistically underpowered (too few animals) and shouldn’t be used for risk assessment. The same applied to several fetal transplant (xenograft) studies that industry was pushing—CPSC staff reminded the readers that both the expert panel and the study authors agreed that the study results were too limited and premature to be used to support public health decisions and, “especially to dismiss the considerable body of data in rodent species and the growing number of epidemiological studies showing [male reproductive effects] in humans that parallel the effects in animals.” (CPSC staff response to public comments, page 13).
Other industry-supported studies were shown to be similarly limited, weak, uninformative, or preliminary. The staff report should be read by all risk assessors, regulators, and policy makers, as a textbook example of the playbook the chemical uses, and will continue to use in other fora where chemicals are being assessed—under the revised Toxics Substances Control Act (TSCA) for example—to obfuscate, delay, and build a phony case for how a government agency is failing to rely on “sound science.”
The CPSC staff patiently answered nearly four hours of questions from the CPSC Commissioners at the briefing last week (which you can watch here and here). It was yet another example of government scientists at a regulatory agency working for years to nail down credible assessments and regulations of toxic chemicals in the face of massive industry pressure (including industry-sparked political pressure). You can read about similar examples in The Delay Game.
Does the story have a happy ending? It could. But only if:
- Congress rejects the chemical industry’s inevitable attempts to overturn the CPSC rule (or punish the Commission for having finalized it);
- Federal and state regulatory agencies (and legislatures!) get serious about confronting and rejecting the chemical industry’s shoddy science and tired tactics and focus on fulfilling their missions to protect public health and the environment;
- Product manufacturers and retailers take the CPSC’s recent actions on phthalates (and also flame retardants) as a signal to adopt their own chemical management policies that shift markets away from using chemicals of concern in products they manufacture or sell to the public.