Richard Denison, Ph.D., is a Senior Scientist.
This post is longer than usual and starts with a rather esoteric topic, but I urge you to read it through, as it vividly shows there is no limit to the lengths to which the American Chemistry Council (ACC) will go to squirm out of a regulatory requirement, even if it means violating rules by which ACC had agreed to abide.
But that’s far from the worst of it. Going farther than even I could imagine when I blogged earlier about its tactics, ACC is sparing no effort to deny your right to know about the health impacts of chemicals, by mustering every argument it can invent – however far-fetched – to keep health and safety studies from being shared with the public.
ACC insists that the U.S. Environmental Protection Agency (EPA) should hassle the European Union (EU) instead of its members for the health and safety data ACC promised to provide – despite the fact that the chemical industry itself has thrown up major roadblocks to such sharing. And reaching a new low in tortured logic, ACC argues that, should EPA succeed in getting its hands on the health and safety data submitted to the EU, EPA can and should deny the public access to those data – despite the fact that the Toxic Substances Control Act (TSCA) clearly prohibits EPA from withholding such information.
First, some needed background. Last week, EPA held a meeting to take public comments on a so-called “test rule” it proposed last October using its authority under TSCA. The proposed rule, which we support, is the fourth in a series of test rules EPA has issued to make good on a promise it made over a decade ago, when it launched the voluntary High Production Volume (HPV) Chemical Challenge.
The entire premise of the Challenge was that the public should have access to basic health and safety information on all high-volume chemicals. Part of the agreement reached between EPA, ACC and EDF that established the Challenge was that EPA would impose testing requirements by rule on manufacturers that did not step up voluntarily to provide a base set of hazard data HPV chemicals they made. Such unsponsored chemicals are commonly known as “orphan” HPV chemicals.
The proposed test rule would require testing of 23 orphan HPV chemicals, the fourth batch of such chemicals for which EPA has issued test rules. Let me repeat: These are chemicals actively being made and marketed in the U.S. at levels exceeding one million pounds every year. Yet not one of the manufacturers of those chemicals was willing to make good on the industry’s commitment to honor the Challenge and voluntarily develop and make public a base set of hazard information.
That has forced EPA to go through the laborious, multi-year (12 years and counting) process of rulemaking just to ensure the public gains access to the most basic of safety information on those chemicals produced in the largest amounts. (This is but one of many shortcomings of the HPV Challenge; for more, see the EDF report High Hopes, Low Marks: A final report card on the HPV Challenge.)
Enter ACC, which is now opposing most aspects of EPA’s proposal and making two specious demands of EPA as to why it should not require ACC member companies to comply with the test rule. These demands were delivered with a straight face by an ACC spokesperson at this week’s meeting, and they’re also included in the comments ACC filed on the proposed rule.
I discuss those two demands next. But the real clincher is where ACC goes after that, so be sure to read to the end of this post.
Demand #1: EPA shouldn’t require our members to submit full copies of the required studies.
In launching the Challenge way back in 1988, EPA tried to offer incentives to companies to get them to volunteer. One small incentive was that those who volunteered up front need only submit a so-called “robust summary” of each study reporting results of new testing, rather than a full copy of the study. (EPA could subsequently request the full study on a case-by case basis.) In contrast, companies who “volunteered” only after their HPV chemical was subjected to a test rule, and companies who decided not to volunteer at all and simply wait for the test rule, had to submit full copies of the studies reporting the new test data.
Moreover, EPA test rules, including the newly proposed one, always require that companies submit full copies of studies developed to comply with the rule. EPA’s proposed test rule states this explicitly: “Data submitted to EPA to meet the requirements of testing under the proposed rule must be in the form of full copies of unpublished studies or full citations of published studies, and may be accompanied by a robust summary.” (p. 65597, emphasis added)
Why? EPA has indicated that full copies of studies are needed because they are “relied upon to demonstrate data adequacy.” While robust summaries can be useful for some purposes, access to full studies by the public as well as EPA is important. In addition to providing important detail, without such access one must simply trust that the company that prepared the robust summary did so accurately and without bias. Providing access both to robust summaries and to full studies embodies the maxim “trust, but [be able to] verify.”
Despite all this and ACC’s prior agreement that full studies should be provided, it now seeks to nickel-and-dime EPA. In its written comments on the proposed test rule, echoed in this week’s oral presentation, ACC states: “While full studies are preferable if available, EPA should accept a robust summary as sufficient for its data needs if a full study is not available.”
“… if a full study is not available.” Hmm, that’s interesting. Why wouldn’t the full study be available? Why would an ACC member be submitting a robust summary of someone else’s study? And how would they know it was accurate if they didn’t have access to the full study?
To recap, here we have ACC arguing that EPA and the public should make do with a robust summary, and that EPA should accept it no questions asked – even if it was prepared by someone other than the company subject to the test rule and that company lacks access to the underlying study.
What’s especially bizarre about this argument is that, in another context, ACC and its members are so adamant about preventing any “unauthorized” use by one company of chemical safety data developed by another company that they are mounting obstacles that threaten to preclude governments from sharing chemical studies with each other at all.
It’s ironic, because a requirement to provide full copies of studies would go some distance toward assuring that submitting parties not only have access to and an understanding of the full studies – but that they also have the right to submit the studies if they did not themselves develop them.
Which brings us to ACC’s second specious demand.
Demand #2: EPA should just ask the European Chemicals Agency for the data.
It turns out that’s not so easy, and it’s the chemical industry that’s to blame.
ACC notes that “the test rule proposal would require the development and submission of studies which, for certain substances, the European Chemicals Agency (ECHA) likely already has in its possession or will receive in the near future under the EU’s regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).” ACC goes on to say:
“EPA should work for an agreement that would allow ECHA to share those studies and others to be submitted under REACH with EPA in confidence.”
Why couldn’t companies subject to the test rule provide those data directly to EPA? According to ACC: “It is often not feasible for persons subject to EPA test rules to obtain data from the Substance Information Exchange Forums (SIEFs) or consortia which own the studies submitted or to be submitted to ECHA under REACH, even by offering to pay data compensation. SIEF or consortia agreements may specifically limit the use of data to REACH compliance, thus precluding authorization for use under TSCA.”
What ACC fails to mention are two salient facts:
1. Those “SIEF or consortia agreements” were not dictated by ECHA; they were negotiated by the chemical industry itself, so any data sharing problems are of the industry’s own making.
2. Those same barriers to data sharing are hampering EPA’s ability to obtain REACH data from ECHA just as much if not more than they hinder companies from doing so.
It’s not ECHA or EPA that is at fault; it’s the chemical industry. That’s because the chemical industry, including ACC, is demanding that there be no sharing of REACH data even between governments without two conditions being met:
The first demand is reasonable: There should be a system that ensures the company that paid to conduct a study is compensated by any other company that seeks to use those data to meet a regulatory requirement. (REACH has such a system, by the way. TSCA does too, though it’s been used rarely in part because so few testing requirements have been imposed under TSCA.)
The second demand is outrageous: That public access to such data must be denied.
Now for ACC’s attempted coup de grace
Did you notice how, several paragraphs up, I had italicized “in confidence” at the end of that first indented excerpt from ACC’s comments? Take a moment to re-read that sentence.
Lest there be any doubt that what ACC means by that phrase is that the public should be denied access, here is what else ACC writes in its comments on the proposed rule (emphases added):
“It should be clear that section 14(b) of TSCA does not preclude EPA from keeping data and information obtained from other agencies confidential.”
[For a refresher on what TSCA Section 14(b) actually says, scroll down in this post to the header that reads “What TSCA says about your right to know.” In brief, section 14(b) says that, with very limited exceptions, health and safety data received by EPA cannot be claimed confidential and withheld from the public – something that section 14(a) does allow for other kinds of data submitted under TSCA.]
Here comes ACC’s really tortured (nay, water-boarded) logic:
“Section 14(b)(1)(A) excludes from the reverse-FOIA provision of section 14(a) “any health and safety study which is submitted under this Act ….” The phrase “submitted under this Act” clearly refers to submissions by persons required by EPA under TSCA to submit information. It may also include submissions by members of the public who submit information under TSCA voluntarily. There is no reason to believe, however, that studies submitted to ECHA under REACH, and then provided by ECHA to EPA for the purpose of inter-governmental cooperation, would necessarily be “submitted under” TSCA.”
Know that whenever ACC says, in discussing the language of TSCA, that something is “clear” or “clearly means X,” it’s a “tell” that the opposite is far more likely to be the case.
ACC goes on:
“Section 14(b)(1)(B) also excludes from the scope of section 14(a) “any data reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A).” This provision should similarly be read to be limited to data from health and safety studies obtained by EPA from private parties in connection with TSCA. “Reported to” is synonymous with “submitted.” “Or otherwise obtained by” refers to information that EPA may obtain from private parties under TSCA by request, from discovery, through subpoenas, or by other means. The phrase is clearly not intended to address confidential data received from other governments.
There’s that “clearly” again. You don’t have to be a lawyer to see ACC’s blatant attempt to recreate TSCA in its own image, adding words that don’t exist in the statute or twisting those that do to serve their own twisted ends.
Here, in sum, is the sleight of hand that ACC is trying to pull off, telling EPA:
- Don’t require our companies to provide data under the test rule if there’s a possibility now or any time in the future that similar data might be submitted under REACH.
- Instead, negotiate an agreement with the Europeans to get the data from them, even though we’ve erected huge barriers to your doing so.
- Should you nevertheless succeed, you must deny the public access to those health and safety data – something you could never do under TSCA if we submitted them to you directly – because what Congress meant when it required public access to any health and safety information “obtained by” EPA is only data we deign to agree to give you, which we won't do.
A new low, indeed.