More TSCA Declassifications

EPA declassified chemical identities in a few more health and safety studies and made some pretty graphs:  http://www.epa.gov/oppt/existingchemicals/pubs/transparency-charts.html

If I’m reading the numbers right, they have declassified about 20% of the 4,025 claims made.  3,242 claims were deemed actually legitimate.  Another 11, 508 studies had made no claims in the first place.  Only 532 of the chemicals were made over 25,000 lb per IUR reporting. Play whatever games you want with the numbers.

 

Regardless, these numbers don’t indicate massive fraud to me.  Good that EPA tightened up on knee-jerk claims, made without serious thought.  But the “secret toxics” issue has been overblown.

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REACH & Confidentiality

Make sure confidential claims have been appropriately made (and paid for) in REACH dossiers and Safety Data Sheets – because ECHA is going to publish REACH registrants and chemical identities using the logic that if it’s on the SDS, it doesn’t matter what is claimed in the REACH dossier.  See announcement and Q & A

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No TSCA Fracking Chemical Disclosure – Maybe

EPA responded to a multi-NGO petition to disclose chemicals used in natural gas fracking under TSCA indirectly:  It will propose a section 8(a) rule (a Preliminary Assessment Information Rule  or PAIR is my guess) and get health and safety studies under section 8(d).  So any chemicals identified in the studies will be disclosed under their new policy.   The Agency said it didn’t want to duplicate state well-by-well disclosure regs.

EPA denied the petition to require testing under TSCA section 4, so if fracking chemicals haven’t been studied, no disclosure.

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TSCA Confidentiality Revoked

EPA continues to declassify chemical identities and health and safety studies submitted under TSCA, bragging they now have 542 declassified documents available in the Chemical Data Access Tool.  Thirty-five companies have been encouraged to release their confidentiality claims and EPA is putting the pressure on new submissions, as well as requiring up front substantiation in the Chemical Data Reporting rule.

If you want to protect confidential business information, you are going to have to work prove it really is legitimate cbi.

EHS Strategies, Inc. can help.

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More TSCA CBI Revocations

EPA revealed another set of chemical identities in health and safety studies June 8, 2011, here.  I think most of them were “voluntary” by companies, but EPA is claiming some were not.

Protect what is legitimate and be ready to back up your claim.  Provide meaningful generic names.  Let it go if you can protect your trade secrets by protecting your company name or if historical information is no longer trade secret.  Quit jeopardizing the ability to protect real trade secrets by being lazy and claiming everything confidential.

EHS Strategies, Inc. can help you with TSCA.

 

 

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TSCA CBI Revocations

EPA declassified confidentiality claims in a batch of 42 health and safety studies (mostly 8(e) notices of substantial risk) March 24, 2011, following through on their promise of transparency.

Certainly there are some old claims out there that are no longer valid (many on what was at the time R&D activity that has either gone commercial or died).  And some claims were pretty bogus to begin with.  But the idea of going back and having to re-substantiate the thousands of claims that have been made over the last 35 years – holy cow!  Believe it or not, some of the claims will still be valid (just like the secret ingredients of Coke).

Certainly there is room for improvements in the generic names companies use so categories of studies can be searched more easily.  Or maybe there are some creative ways to allow 3rd party confidentiality disclosure agreements for limited studies, instead of massive fishing expeditions.  See my other blogs on the topic.

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EPA Exercises New TSCA CBI Policy

EPA announced it has rejected confidentiality claims for chemical identity of 14 chemicals in health and safety studies under TSCA.  The agency is narrowly interpreting TSCA to only allow limited claims of confidential business information (CBI) especially for chemical identity in studies.  It remains to be seen if companies can justify some of their claims.

As commented on before here and here, many companies have gone too far in making knee jerk CBI claims.  But there are times when legitimate protection is needed.  We’ll see if the companies challenge EPA.

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TSCA: No More Secret Chemicals

EPA effectively closed down any real opportunity to claim chemical identity confidential for new chemicals and for chemicals for which a health, safety or environmental study is submitted under TSCA.  See http://edocket.access.gpo.gov/2010/2010-12646.htm

The only protection is to keep your company confidential and patent the novel chemical identity (and good luck protecting that).  The only possible exception is if your chemical identity is a process description (“reaction product of…”) rather than a molecular one.

There are some legitimate periods when chemical identity itself has tremendous economic value and little risk information value – the period prior to commercial manufacture.  That period of R&D is when studies will be done.  Some R&D studies may be reportable under section 8(e) according to EPA’s over-expansive interpretation of that provision where exposure has no weight in the “substantial risk” determination and will be submitted with a PMN if the chemical looks commercially promising enough to do so.  Given the length of time it takes to move a PMN through EPA this could give significant lead time for competitors to pick up on the chemistry or a variant.

And the public’s need to know on a chemical that isn’t on the market?  Well, maybe it’s got some structure relationship and could be informative on a category of chemicals . But in that case, a generic chemical description placing it in the relevant category could serve just as well.

Maybe the lawyers can find some wiggle room, but I doubt it.

The likelihood confidentiality be allowed in any reformed TSCA is nil.

Previous TSCA secret chemical post

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TSCA: States Want to Know

Re NY Times article on 13 states wanting Congress to open up TSCA confidential information to them and the public: http://nyti.ms/cP4F7V

Yes, it would be good to share information with states that EPA collects under TSCA.  The problem is that states are rotten at taking care of confidential information.  They are leaky sieves.  Of course, they’d just as soon not have to treat any of the info as confidential because the public has a right to know and (mostly) it’s a pain to manage confidential information.  Find the state’s letter here: http://www.maine.gov/dep/oc/safechem/13states_release.html

Yes, but…. Companies do have legitimate claims on proprietary information they spent a lot of effort and dollars developing (crafting new molecules, innovative functions and applications in products, processing technology).  I’m not talking about data on health and environmental effects and risks of their operations and products.  That kind of info can and should be open – though not in every excrutiating detail.  Using generic characterizations (category names for chemicals, generic use descriptions, volume ranges), it is possible to describe the nature of exposure and hazard for others to review.  If they need more detail, work out a deal with the company to view it, with agreement not release specific proprietary information to competitors.

And, yes, companies need to quit being so knee-jerk in claiming everything confidential.  Furthermore, being embarrassed or worried about revealing risk information is not an acceptable basis for a confidentiality claim.  Communicating risk to the public is a major responsibility of product stewardship.  Companies need to figure out how to communicate adequate information to the public or they will lose any and all protection for everyone.

See more discussion here.

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TSCA – Secret Toxics?

Latest cry for transparency in the Washington Post: “Use of potentially harmful chemicals kept secret under [TSCA] law” http://bit.ly/4zTzjC

Yes, there are companies who claim too much information to be secret under TSCA, including the very identity of a chemical.

But then there are valid reasons that some chemicals are claimed confidential.  When a company has invested a lot of money to develop a new chemical molecule, it’d be nice not to have to give it away in a government document available to the public – especially potential competitors.  Chemicals for which PMNs and 8(e) notices have been filed are mostly at the R&D stage when  But that doesn’t have to mean there is no public information.  In general,  generic names must be provided that reveal as much as possible, especially about structures that have toxicity concerns.  Companies have naturally pushed the envelope of what they can get away with.

How do they get away with that?  EPA requires up front written substantiation under TSCA with regard to the submission of new chemical notifications under TSCA PMNs and notices of substantial risk (8(e).  But the agency has been less than rigorous about always vetting the substantiation of those claims.  And even if they do push back initially, over time the validity of the claims may disappear.  Companies that have placed the chemical on the market where competitors can analyze it, or even when the company advertises the chemical composition, there is no requirement to withdraw the claim they made years ago.  But sometimes the claims of trade secret remain valid – especially for site limited intermediates and hard to analyze compositions.

Frankly, going back and resubstantiating claims is a huge pain – for companies and for EPA.  But maybe necessary, at least for certain categories of chemicals.  If a chemical never makes it to sustained commercialization (a large portion of new PMN chemicals) there’s not much point.  But after a certain significant volume (10,000 kg?) is marketed, maybe so.

But what about those statements made in the article?

– “95 percent of the notices for new chemicals sent to the government requested some secrecy”  Hmmmm… “some secrecy”  like how much they were going to make?  the specific uses? what plant sites were going to make it?  Business plans that are still in the works, since PMNs have to be submitted several months in advance of the first commercial molecule being made?

– “…more than half of the 65 “substantial risk” reports filed with the Environmental Protection Agency involved secret chemicals.”  That’s because most of these notices are triggered by toxicity studies being conducted on R&D chemicals.  Some of them are never PMN’d or commercialized because of the rotten tox results seen in these screening efforts. The whole point of TSCA, after all.

– “Of the 84,000 chemicals in commercial use in the United States … nearly 20 percent are secret”  First, EPA does not know if there are 84,000 chemicals in commercial use.  Only 6,200 were reported under the last Inventory reporting (albeit polymers and inorganics and chemicals made under 25,000 lbs weren’t reported).  A general rule of thumb is that only 10% of R&D efforts generate any first year sales.  And many of those fail to last in the marketplace.

– “Of the secret chemicals, 151 are made in quantities of more than 1 million tons a year and 10 are used specifically in children’s products, according to the EPA.”  Not sure where this came from.  EWG claims 151 over 300,000 lbs, 10 in children’s products.  Not quite the same as a million tons.  EPA hasn’t said how many, if any, of the Inventory Update reports claimed chemical identity secret.  Surely they would have touted that if it had occurred.  I don’t know where these numbers come from.

– ZetaFlow and Firemaster 550 allegations.  I don’t know enough to comment.  I do believe that companies should provide doctors information needed to treat their patients (which may or may not include a specific chemical identity that an MD hasn’t a clue what it means).  My experience is that the toxicologists in a company will talk to doctors.  What they don’t do is contribute to fishing expeditions. If necessary, confidentiality agreements can be prepared with academic and NGO researchers.

– If you need help figuring out what legitimate confidentiality claims to make for TSCA contact EHS Strategies, Inc.

Bottom Line: I think there is opportunity under today’s law to appropriately use trade secret protection and to share sufficient information to do risk assessment and management.  If reform is needed, it may include resubstantiation of some, but not all, claims and enforcement of the rules.

News 1/21/10:  EPA says it won’t allow confidentiality for chemical identity  substantial risk notices under TSCA 8(e) if the chemical identity appears on the TSCA Inventory.  In general this seems OK, particularly since companies can hide their identity and use information that may be in the notice.  But once in a blue moon there might be legitimate claims.  EPA seems to allow for that by giving the company a chance to prove the claims are valid.

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