Richard Denison, Ph.D., is a Senior Scientist.
On May 12 of this year, the Environmental Protection Agency (EPA) sent a proposed rule to the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA) for its review, which is supposed to be completed within 90 days. The proposed rule is not considered a major rule, is classified as “not economically significant,” imposes no unfunded mandates and is unequivocally allowed under EPA’s statutory authority under the Toxic Substances Control Act (TSCA).
The proposed rule would establish a so-called “chemicals of concern” list and populate it with one chemical and two chemical categories. All of these chemicals are well-studied, already widely identified to be chemicals of significant concern and subject to numerous regulations by governmental bodies both in the U.S. and abroad.
Yet, as of today – more than seven months after receiving the draft of the proposed rule from EPA – OMB has not allowed EPA to release it for public notice and comment.
In 1976, when passing TSCA, Congress gave EPA the express authority to establish and populate a “chemicals of concern” list. There’s simply no excuse for OMB’s delay.
Clear statutory authority
TSCA’s Section 5(b)(4) authorizes EPA to promulgate a rule to identify “chemicals of concern” by publishing a list of chemicals that present or may present an unreasonable risk. Here’s the statutory language:
“The Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may present an unreasonable risk of injury to health or the environment.” (codified as 15 U.S.C. 2604(b)(4); emphasis added.)
According to the description of the proposed rule posted on OMB’s website, EPA’s proposal lists the following three chemicals as “of concern:”
- a category of eight phthalates,
- a category of polybrominated diphenyl ethers (PBDEs), and
- bisphenol A (BPA).
It is hard to imagine that anyone could, with a straight face anyway, dispute the legitimacy of identifying these three chemicals/groups as chemicals of concern.
Ample information exists to clear the threshold under TSCA for chemicals of concern
First, consider that this section of TSCA allows EPA to identify chemicals that “may present” an unreasonable risk to human health or the environment. That standard is considerably less strict than the infamous “present or will present” standard that stopped EPA in its tracks when it tried to ban asbestos two decades ago.
The “may present” standard is the same one that must be met in order for EPA to require a chemical to be tested using its TSCA Section 4 authority. EPA often has a hard time meeting that threshold for “data-poor” chemicals, a circumstance that I and others have characterized as a rather diabolical Catch-22.
But the chemicals proposed by EPA are hardly data-poor, leading some knowledgeable observers to argue that there is plenty enough information on these chemicals that they should have no trouble meeting the “may present” threshold. Consider this statement from a May, 2010 paper (see page B-3) co-authored by the former director of EPA’s Office of Pollution Prevention and Toxics – who himself proposed using Section 5(b)(4) in 2008, but withdrew the proposal in the face of staunch opposition from the American Chemistry Council (ACC) and others in the chemical industry:
“Importantly, in the case of the three CAP [chemical action plan] chemicals/groups of chemicals that EPA has identified for Section 5(b)(4) listing consideration, considerably more detailed information is available on both hazards and exposures … . This would suggest that as to these listings, EPA may meet and exceed the burden required under the … “may present” standard.” (emphasis added)
Exposure to these chemicals is incredibly widespread
One would have a hard time finding chemicals to which exposure is more widespread than those identified by EPA for listing.
Past and current high production volumes and diverse use patterns alone indicate the potential for widespread exposure. The various uses of these chemicals include food can linings, a host of products made using commodity plastics, personal care products, furniture and carpeting, thermal paper – the list goes on and on.
Furthermore, with each of these chemicals, we have direct evidence of widespread human exposure – through biomonitoring done by the federal government. The most recent data collected by the Centers for Disease Control (CDC) documents that a majority – typically the vast majority – of Americans carry measurable levels of all of these chemicals in their bodies.
Available toxicity data are more than sufficient to warrant listing as chemicals of concern
While not without controversy or ongoing debate, significant evidence of the toxicity and potential risk these chemicals pose to people and the environment is already available. I won’t delve into that vast topic here; suffice to say EPA has already summarized the evidence in its action plans for these chemicals/groups.
That level of evidence far exceeds that to which EPA typically has had access when successfully promulgating a TSCA Section 4 test rule for a chemical, to which OMB officials have had no cause to object. And in contrast to those cases, the present proposed rule does not require companies to spend one dime on testing.
EPA is very late to the party for these chemicals
One of the concerns expressed about EPA’s proposed listing of these chemicals is that it would “stigmatize” them or amount to a “black list.”
It’d be one thing if EPA were the first authority to recognize and seek to act on concerns about these particular chemicals. But in fact, EPA is among the last government body, both in the U.S. and abroad, to step in.
Numerous foreign, state and local governments have acted to ban or restrict particular uses of these chemicals. Even the mainstream media follow every such move. Here’s a nice summary of actions taken on BPA in a USA Today article written in response to the decision late last month by the 27 nations of the European Union to ban the hormone-disrupting chemical from baby bottles:
“Canada, France and Denmark already have banned the use of BPA in baby bottles. The U.S. Food and Drug Administration has expressed "some concern" that BPA may alter the brain, behavior and prostate gland in children, both before and after birth. [Note: So has the National Toxicology Program of the National Institute of Environmental Health Sciences.]
“Legislatures in at least 20 states have considered banning BPA in children's products. As of October, seven states had voted to ban BPA in baby bottles: Connecticut, Minnesota, Washington, Wisconsin, Vermont, Maryland and New York. [NOTE: Just last week, Massachusetts became the eighth state to do so.]
“Chicago and four counties in New York — Albany, Rockland, Schenectady and Suffolk — also have banned BPA in baby bottles.
“A Massachusetts health advisory warned pregnant and nursing women last year to choose fresh or frozen products, rather than food in cans, which often contain BPA in their plastic linings.”
The same article points out that EPA’s focus is on potential environmental effects of BPA (presumably because FDA is covering human health), noting that EPA is considering “adding BPA to its list of chemicals of concern, looking at levels of BPA in surface, ground and drinking water.”
That’s just BPA; similar lists of actions could be readily assembled for phthalates (some of which Congress banned from kids’ products in 2008) and for PBDEs.
How much more stigmatized could these chemicals get???
[As an aside: Much has been made of the fact that EPA has not used this listing authority before, to which I perhaps too blithely say (given the history of inaction under TSCA), there is no time like the present. It’s worth noting, though, that EPA has proposed to do so at least twice: Once in 2008 as mentioned earlier, the other in 1981, in a Federal Register notice pertaining to polychlorinated terphenyls (PCBs’ cousins) and signed by none other than then-EPA Administrator Anne Gorsuch. The latter proposal was also withdrawn, also after staunch opposition from ACC under its earlier name, the Chemical Manufacturers Association; see CMA’s comments at the end of this file. At least ACC has been consistent over time!]
Why a chemicals-of-concern list makes market sense
Industry often complains that, when a chemical becomes subject to legislative or regulatory restrictions, companies are never given enough time to comply, time they say they need to identify the means to eliminate or replace the chemical without undue market disruption or loss of market share.
What better way, then, to address this problem, than to identify – well in advance of any regulatory restrictions – chemicals that are going to come under increasing scrutiny? By doing so, government can signal to both producers and users of a chemical that they need to seriously examine their practices, and either prepare to defend the safety of the chemical or their particular use of it, or begin to transition away from it.
In many cases, it just might be that the market can move faster to solve the problem than government can.
The listing of chemicals well in advance of any regulatory action that would restrict their production or use is a hallmark of most modern chemicals policies. Canada did it on a big scale, publicly identifying some 4,300 chemicals that met hazard and exposure “categorization” criteria set forth under the Canadian Environmental Protection Act (CEPA), and then prioritizing the list for further regulatory action. Europe is doing it, identifying and publishing its so-called “candidate list” of substances of very high concern well in advance of any actual regulation of them. Policies enacted in Maine, Washington and California all call on government to publicly identify chemicals of concern.
The public and the market – including export markets globally – have a right to know
I suspect that one of the reasons the chemical industry has its knickers all in a twist over this proposed action by EPA is because a Section 5(b)(4) listing can trigger a requirement that companies producing a subject chemical notify EPA if they intend to export that chemical to another country. EPA must in turn notify the receiving country of the listing. Here’s the relevant TSCA provision, Section 12(b)(2):
“If any person exports or intends to export to a foreign country a chemical substance or mixture for which … a rule has been proposed or promulgated under section 5 …, such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of such rule … .” (codified as 15 U.S.C. 261(b)(2); emphasis added)
But why in the world shouldn’t a receiving country be informed of the listing of a chemical by EPA as a chemical that “may present an unreasonable risk”?
Isn’t that kind of informed consent what ought to be meant when the chemical industry describes its Responsible Care program as follows (emphases added)?
“Responsible Care is the chemical industry’s unique global initiative that drives continuous improvement in health, safety and environmental (HSE) performance, together with open and transparent communication with stakeholders.”
“Responsible Care has fostered the development of the Global Product Strategy (GPS) which seeks to improve the industry’s management of chemicals including the communication of chemical risks throughout the supply chain.”
And what about this characterization of its Global Product Strategy (emphases added)?
“Our member associations and companies will be more transparent about their product safety assessment processes and provide access to information in a suitable format to coproducers and customers to increase public confidence that governments are fulfilling their role and industry is meeting its voluntary commitments and regulatory requirements. We will, of course, share this information with governments to meet regulatory requirements and improve industry performance in countries where such regulations are not yet in place. Along the way we will provide capacity building for smaller and medium sized enterprises in our industry, as well as downstream customers and governments in developing countries. GPS aims to reduce existing differences in the safety assessment of chemicals between developing, emerging and industrialized countries.”
How better to “reduce existing differences” between developing, emerging and industrialized countries than to ensure the same information provided to the U.S. government and available to U.S. citizens is made available to those of other countries?
OMB should let the public comment process work
Not having seen the actual proposed rule, I expect there are elements of it that warrant scrutiny and will engender comment. EDF and no doubt many other stakeholders will have a lot to say about it. Companies will no doubt argue ‘til the cows come home why their chemicals shouldn’t be on the list. (No fewer than four meetings between groups of industry representatives and OIRA staff have been held on this proposed rule over the last several months.)
Congress mandated that EPA develop and populate such a chemicals-of-concern list by rule, which, of course, requires opportunity for notice and public comment. Congress went even further in this case, mandating that interested persons be given an opportunity to comment orally as well as in writing and that EPA publish the basis for its “may present” findings in the final rule (see TSCA Section 5(b)(4)(C), codified as 15 U.S.C. 2604(b)(4)(C)).
EPA will have to consider all the comments it receives and modify its proposal accordingly. And, of course, OMB will have another shot at it before it can be finalized.
So, OMB, for heaven’s sake, let’s get on with it.