EPA's right-to-know effort declassifies the chemicals in 42 health and safety studies

Richard Denison, Ph.D., is a Senior Scientist.

EPA has just released today the full versions — showing the identities of the chemicals in question — of 41 "substantial risk" notices of health and safety studies it had previously received from companies that had denied the public's right to know those identities by claiming them to be confidential business information (CBI).  These notices had been submitted pursuant to Section 8(e) of the Toxic Substances Control Act (TSCA).  One additional notice of a health and safety study that EPA had received under Section 8(d) of TSCA was also released today with its chemical identified.

What's most significant about today's posting is that it makes publicly available the identities of chemicals associated with health and safety data that:

  1. the submitting companies themselves believed the data “reasonably supports the conclusion that [the chemical] presents a substantial risk of injury to health or the environment;” and
  2. should have been publicly available all along, based on the plain language of TSCA that disallows health and safety studies to be claimed CBI in the first place.

The declassifications posted by EPA today arise from two sources:

  • Some are "voluntary" withdrawals of CBI claims for chemical identity made by companies in response to EPA's "TSCA CBI Declassification Challenge," via which EPA's requested that companies review their past claims and inform EPA if the companies considers the claims no longer to be necessary.
  • Others are the result of EPA's own review of chemical identity CBI claims made by companies in submitted health and safety studies; these reviews led the Agency in February to issue determination letters denying some of those claims and announcing its intent to release the associated chemical identities after waiting the requisite 30 days required by law to give the companies a chance to seek judicial relief.  EPA sent those letters to five companies in reference to 14 chemicals.

We'll likely have more to say about these specific notices as we look more closely at them, but here are some interesting facts we've already noticed:

  • Ten of the 42 notices had the company name redacted.
  • EPA staff have told me that today's declassifications include all of the notices of health and safety studies that were identified in the Agency's determination letters sent to the five companies.  This suggests that none of the five companies opted to challenge EPA's determinations.
  • Eight of today's declassified notices are clearly identified as pertaining to studies submitted by those five companies:
    • 5 notices from Givaudan Fragrances Corporation
    • 1 notice from Japan Techhnical Information Center, Inc.
    • 1 notice from JSR Micro, Inc.
    • 1 notice from Nalco

No notices were identified as submitted by the fifth company, Promerus LLC.  Presumably their notice or notices are among the 10 where the company name was redacted.  It's also possible there are more notices from the other four companies among those with redacted company names.

  • At least 11 — and likely 14 — of the declassified notices are for studies submitted by DuPont; most but not all of these include a statement from the company indicating it is agreeing to declassification based on its review of past claims in response to EPA's Challenge.  (Three notices with company name redacted are of the same format as the DuPont notices, leading us to assume they too are from DuPont.)
  • Three of the notices are from Procter & Gamble, including one it indicates is in response to the Challenge and one in response to a recent FOIA rquest relating to oil dispersants.

I am very glad to see EPA's payment of this first dividend on its promise to ensure that health and safety information submitted under TSCA is, as Congress clearly intended, made publicly available — including the identity of the chemicals to which the information pertains.  EPA needs also to provide the public with the means to track the status of EPA's challenges, reviews and determinations pertaining to the legitimacy of CBI claims, and of industry's compliance with or challenges to EPA's noble effort.

As this effort proceeds, let's hope it reaches the hundreds or thousands of other studies that should have been made public long ago.

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2 Comments

  1. Jen
    Posted March 29, 2011 at 4:48 pm | Permalink

    Fascinating, and encouraging! Is there any way for a consumer or tiny advocacy group to discover in what consumer products or applications there might be a route of exposure to these risky chemicals?

  2. commonscents
    Posted April 2, 2011 at 8:37 am | Permalink

    That's a good question Jen.

    In the case of Givaudan Fragrances Corporation, the six chemicals that it gave the EPA risk notice on are all listed on the International Fragrance Associations (IFRA) websites ingredient list (e.g. the list of ingredients its customers put in consumer goods worldwide). here's the URL: http://www.ifraorg.org/en-us/Ingredients_2

    Who knows how many consumer products contain these ingredients? Sadly, the answer is that we don't know because the companies have petitioned the FDA for Trade Secrecy status for most of the ingredients in its scented products. After reading the Givaudan notices, it really makes me wonder if companies sought the Trade Secret in the first place because it had a truly unique formula or because they were concerned with the consumer reaction to full ingredient disclosure.

    Perhaps the FDA should follow the EPAs lead, if it hasn't already, and require companies to reassess its Trade Secrets (and the apparent ease in gaining trade secrecy status with the agency) to ensure that the health and safety of the public is not subordinate to the alleged Intellectual Property of companies.

    Nonetheless, it's great that the EPA is making this information public. Thank you EDF.

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