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Will a Threat to Chemical Innovation Snatch Defeat from the Jaws of Victory on TSCA Reform?

If you read the March 29, 2016, blog post, “Will Private Interests Trump Public Ones When It Comes to Our Right to Know Under TSCA?” by Dr. Richard Denison of the Environmental Defense Fund, you would come away thinking the chemical industry has never publicly disclosed information about health and safety studies, never publicly relinquished any confidential business information (CBI) on chemicals, and never been required to substantiate CBI claims with EPA. In fact, the industry has done, and continues to do, all of those things – and has been publicly recognized by EPA for it. That’s why it is often not what Dr. Denison says in his blog that is important to know, but what he doesn’t say.

For example, Dr. Denison’s attack on CBI language in the House TSCA reform bill leads one to believe that the public would receive NO information about a chemical under the bill. That’s simply false. As passed, the House bill would require EPA to make generic chemical names and health and safety data (i.e., toxicity data) public. The bill also includes language that would require increased sharing of information with state, local and tribal governments and with medical professionals.

Dr. Denison also doesn’t say that CBI claims do not reduce the amount of data EPA receives on chemicals from which to make regulatory decisions. If a manufacturer does not have test data, EPA will continue to use precautionary approaches involving potential exposures, modeling tools, and data on analog chemicals and chemical categories before a chemical ever reaches commerce. If the agency feels it needs test data it will request it. Companies regularly continue testing chemicals even after EPA approves them. It is then the agency’s job to approve, restrict, or ban the chemical.

By statute, EPA is required to protect “any data which discloses processes used in the manufacturing or processing of a chemical substance.” SOCMA believes EPA’s historic practice in this regard has been the correct one: i.e., EPA has protected chemical identity, even where it does not directly disclose a process, in cases where knowing a chemical’s detailed identity could allow a skilled chemist to make an accurate deduction about the way in which a process is designed. This sort of reverse engineering is particularly threatening to specialty/batch chemical manufacturers, that SOCMA represents, where many companies are highly specialized in particular forms of chemistry with niche applications.

It is short-sighted to assert that disclosure of a chemical identity does not disclose process information except where the identity explicitly contains process information. For a simple commodity chemical, such as formaldehyde, that has been manufactured for nearly a century, it is correct to say the structure does not reveal the manufacturing process even if any chemist could figure out independently that formaldehyde can be generated by oxidizing methanol. In the case of a palladium catalyst, for example, where the chemical structure uniquely defines the activity of the compound, knowing the chemical identity would indeed reveal the essence of the invention and thus reveal CBI and allow it to be copied. EPA must retain its statutory responsibility to protect CBI by not revealing a chemical identity when a legitimate claim is made that a structure uniquely defines the manufacturing process or the essence of the invention.

At bottom, disclosure of the specific identity of a chemical is not necessary in order for the public to understand a health and safety study that has been submitted to EPA. While EPA staff use predictions based on chemical structure to assess potential risks associated with a given chemical identity, most health and safety studies submitted by industry rely on toxicity studies. Such studies are conducted with objective test methods whose results have agreed-upon significance. Toxicologists may rely in part on chemical identity to choose appropriate testing methods, but once test results are collected, analyzed and presented, the hazard information from the study speaks for itself, independent of what name is used to identify the particular chemical being assessed.

Dr. Denison also doesn’t tell you SOCMA has compromised substantially to get a bipartisan bill that Congress can pass. After many years of the “my way or the highway” approach under which previous Congresses addressed this issue, all stakeholders learned that that approach to TSCA reform leads only to stalemate. Both sides must give. For our part, on CBI, SOCMA supports the reasonable limitations on CBI protection included in the House bill because they will help increase the transparency Dr. Denison seeks. For example, companies would have to reassert, and resubstantiate, their CBI claims periodically. This fixes one of the core problems under the current law: the open-ended protection of CBI. On this issue, Dr. Denison is now resorting to the destructive strategy of my-way-or-the-highway just when TSCA reform is finally within reach.

Also, Dr. Denison is being too modest about his own input into TSCA reform legislation. While he laments how much input SOCMA proudly contributed, he makes no mention of his own. Comparatively, ours has been substantially smaller. Trust me, much has been left on the cutting room floor from our perspective for the sake of compromise, and Dr. Denison will be the beneficiary of much of it, thanks to his lobbying, if Congress passes a TSCA bill.

Lastly, the title of Dr. Denison’s blog is curious because, in the House CBI language, neither the private interest nor the public interest trumps the other. Rather, each side cedes ground to the other. Neither side gets everything it wants. That’s what occurs in legislative compromise. As it stands, the Senate bill’s CBI language completely trumps private interests.SOCMA does not apologize for seeking the compromise struck in the House bill on CBI protection, especially when it strikes a balance between public disclosure and job-creating innovation. The fact is, today’s chemical innovations tend to be greener than many existing chemicals added to the TSCA Inventory years ago because there are reasonable safeguards in place preventing competitors from undermining the latest innovations at the moment they are manufactured. 

Accepting Dr. Denison’s position on CBI unnecessarily jeopardizes not just TSCA reform’s chances of passing but also the jobs of thousands of American workers who produce chemistries upon which millions rely every day.
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