Richard Denison, Ph.D., is a Senior Scientist.
It’s very disheartening to see just how far the American Chemistry Council (ACC) has moved away from anything resembling a good-faith effort to debate and advance meaningful reform of the Toxic Substances Control Act (TSCA). There’s more than enough in TSCA reform for stakeholders to debate and disagree about without adding distortions and outright falsehoods to the mix, yet ACC seems intent on doing just that.
The latest indication? An April 16, 2013 post to ACC’s blog titled “A new year, but the same unworkable Safe Chemicals Act.” The post purports to identify four fatal flaws in the Safe Chemicals Act of 2013, which was introduced on April 10 and is cosponsored by 29 Senators. The first two utterly ignore or fault the legislation for major changes made to it to address industry concerns, while the latter two once again restate outright falsehoods ACC has made about the Act – claims that ACC knows are false.
Let’s take the latter two “flaws” first.
ACC claim: The Act’s safety standard is a zero-risk standard
As it has repeatedly for several years, ACC’s blog post claims the Safe Chemicals Act’s safety standard is a “zero risk” standard. ACC knows this to be false – because its member companies that make food-use pesticides have operated under the exact same standard for nearly 20 years, since 1996.
At issue is the section of the Act that requires that chemicals be shown to meet a standard of “reasonable certainty that no harm will result to human health or the environment.” This language is taken directly from the Food Quality Protection Act of 1996 (FQPA). Now here’s the irony in ACC’s claim: The “reasonable certainty of no harm” standard was put into FQPA expressly to replace an actual zero-risk standard that applied prior to its passage – the so-called Delaney Clause. Indeed, industry had fought hard for years against the Delaney Clause, which dated all the way back to 1958, and it hailed its replacement with the “reasonable certainty” standard in FQPA as a major victory.
The legislative history of FQPA makes clear that the “reasonable certainty” standard is not zero-risk. Rather, it refers to EPA’s use of quantitative risk assessment to set an acceptable level of risk, taking into account exposures from all sources and the heightened vulnerability of children. See pages 40-41 of this House Report that accompanies the final adopted version of FQPA.
Likewise, EPA’s implementation of FQPA is and always has been based on quantitative risk assessment to set an acceptable level of risk. See, for example, EPA’s website: “Setting Tolerances for Pesticide Residues in Foods.”
ACC claim: “Manufacturers would be required to conduct an aggregate exposure assessment of every chemical they produce.”
Wrong again. EPA, not industry, assesses chemical risks under the Act. ACC’s blog post repeats this false claim that ACC has been making since 2010. And it knows this claim is untrue.
Under the Act, EPA – not manufacturers – makes safety determinations, based on its assessment of the aggregate of exposure from the various uses and sources of a chemical. The Act could not be clearer in this regard; section 6(d)(1)(B)(ii) states:
“(ii) DUTIES.—For purposes of this Act—
(I) it shall be the duty of the manufacturer or processor of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the safety standard; and
(II) it shall be the duty of the Administrator to determine whether a chemical substance meets the safety standard.”
(emphases added; see pp. 98-99 of the Act)
ACC first made this false claim at a hearing in July 2010, relating to a similar provision in TSCA reform legislation under consideration by the U.S. House of Representatives. Cal Dooley, ACC’s President and CEO, made the following statement:
“For example, the bill requires that “aggregate exposure” to a chemical or a mixture meets the “reasonable certainty of no harm” standard.
This means that when a chemical or mixture is listed for a safety determination, the manufacturer(s) carries the burden of showing with reasonable certainty not just that the company’s use of the chemical and any resulting exposures from those uses pose no harm, but that all other aggregated exposures from all other uses of the chemical pose no harm. It is not clear to us how any company could actually do that.” (emphases in original)
At that hearing, Mr. Dooley’s statement was directly challenged and corrected, both by one of the sponsors of the bill and by me, who was also testifying at the hearing. See pp. 95-6, lines 1815-1859 and pp. 94-5, lines 1792-1801, respectively, in this transcript of the hearing.
Since then, the language in question was even further refined to make absolutely clear that EPA, not industry, does the aggregate exposure assessments. Yet Mr. Dooley and ACC continue unabated in repeating this false claim.
Of course, none of this addresses the substantial merits of and support for the common-sense notion that judging the safety of a chemical should take into account the fact that people are often exposed to it from more than one source. This feature of the Safe Chemicals Act’s safety standard has been endorsed by major medical groups and is a key recommendation of the National Academy of Sciences (an august body that in other contexts ACC loves to cite as the ultimate authority).
So now let’s look at the first two “flaws” ACC claims are in the Safe Chemicals Act.
ACC claim: “Its proposed prioritization system is unclear and circuitous, and frankly doesn’t make much sense.”
This claim carries two-fold irony.
First, this section of the bill was drastically rewritten from the 2011 version, almost entirely in order to incorporate chemical industry proposals that had surfaced in various dialogues both on and off Capitol Hill.
The batching of chemicals was introduced to “meter in” to the prioritization process the large number of chemicals on the market, so as to minimize burdens on industry as well as EPA. Categorization of chemicals was introduced so that EPA could identify and set aside chemicals of low concern right up front. The remaining chemicals would be prioritized: a) based on both hazard and exposure, and b) using only existing information – both features added to respond to key industry demands.
I guess there’s just no pleasing some folks.
The second irony is that ACC has proposed a prioritization scheme of its own that is far more complex and convoluted than the one in the Safe Chemicals Act.
ACC claim: “The SCA would … severely restrict a manufacturer’s ability to protect the identity of chemicals they have developed.”
Here again, ACC wholly ignores the major changes made to this section of the bill to address industry concerns. Under the original 2011 bill, identities of new chemicals generally would not have been eligible for protection as confidential business information (CBI). But under the revised 2013 bill, with the exception of chemicals of very high concern, new chemicals can enter the market and their identity can be masked for a period of time designated by the manufacturer as necessary, as long as EPA deems the period to be reasonable. In addition, the length of that period can itself be claimed to be CBI if it would reveal proprietary information about investment in or revenue from sales of the chemical. Moreover, that period can be renewed for an additional five years as long as the original CBI criteria are met. Finally, this allowance applies even to the identity of a chemical in a health and safety study – a substantial weakening of the status quo under current TSCA.
These changes amount to major concessions on the part of the bill sponsors. Yet ACC not only fails to acknowledge them, it continues to use the same hyperbolic language to describe them that it was using to describe the original language back in 2010 and 2011.
Are TSCA chemicals really heavily regulated?
Lastly, I simply must respond to another claim ACC makes in its post, namely that EPA’s imposition of some type of condition on chemicals “more than 2600 times” constitutes extensive regulatory action. This claim, with a bit more detail, was also made in another ACC post responding to the New York Times’ April 18, 2013 spot-on editorial, A Toothless Law on Toxic Chemicals.
What ACC fails to mention could fill a tanker truck:
- Virtually every one of those “actions” was taken on a new chemical, where TSCA gave EPA a bit more bargaining power to negotiate with companies to accept such conditions. Only a tiny fraction represent actions taken on the 62,000 chemicals that were already on the market and were grandfathered in when TSCA passed in 1976 – chemicals that still today represent the vast majority, both by count and by production volume, of chemicals in use.
- Virtually all of the 2600 actions were applied in the context of EPA’s review of the new chemical notifications it receives. Since TSCA was adopted, EPA has received more than 50,000 such notifications (including 37,000 premanufacture notifications (PMNs) and 14,000 exemption applications or notifications). So the 2600 actions amount to a condition being placed on only about 5% of new chemicals – the only ones where EPA could meet its burden of finding potential risk or high exposure.
- The other 95% of new chemicals – the great majority of which are accompanied by no safety data – have literally sailed through EPA’s 90-day review period. Moreover, once those chemicals go on the market and get added to the TSCA Inventory, anyone and everyone can make and use them for any purpose and in any amount without even notifying EPA that they are doing so. (See this post for more detail on the limitations of EPA’s new chemicals program.)
- So, in sum, under TSCA only one in 20 new chemicals, and virtually none of the much larger number of existing chemicals, have any regulatory condition whatsoever applied.
All of this distortion, omission and robotic repetition of falsehoods make it hard to reach any conclusion other than that ACC has no real interest in debating or discussing meaningful TSCA reform. Nor does it suggest much reason to hope or expect ACC will ever be willing to put in the hard work and compromise (which we in the health and environmental community and a scant few in the consumer products industry have been willing to do) that will be needed to actually reach an agreement on reform legislation.
And that’s a shame.