Archive for the ‘TSCA Reform’ Category

Life Cycle Thinking blog is moving.

I will continue to provide commentary about TSCA, REACH, product stewardship, sustainability, environmental marketing claims and more as part of the redesigned EHS Strategies, Inc. website.

Georjean Adams

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TSCA Reform 2013

New bills on TSCA reform are due in 2013 – Sen. Lautenberg reintroducing his Safe Chemicals Act and Sen. Vitter is expected to introduce a paired down version of TSCA revisions.  Given the major pressures on Congress – fiscal mess, immigration, gun control, etc. and the Republican House – it’s not clear anything will pass this year, but there should be more to chew on.  The problem is everyone wants some thing different in “modernization” of TSCA: make it easier for EPA to issue regulations, but not too easy and convince the public chemicals are safe – whatever that means.

EPA is showing some gumption in using the extensive authorities it already has under TSCA with more SNURs, extended information-gathering under the Chemical Data Reporting rule and “Work Plans.”  I think they are still too timid (not that they can’t go too far sometimes). If they would just work their work plan based on opportunities for real risk-reduction priorities, a lot could be accomplished – although not the massive chemical bans desired by the NGOs.  (Hmmmm… could it be they can’t prioritize risk-reductions because there aren’t significant risks out there?)

It is sad that EPA’s TSCA program seems to need detailed legislative instructions to get down to work.  Unfortunately, that just encourages Congress to get into the business of writing detailed regulations instead of legislation.  Instead of knowledgeable scientists and bureaucrats, we get a handful of behind-the-scenes Congressional staff and special interest ghost writers effectively issuing regulations born of political deals, not public notice and comment rulemaking.  Instead of being able to initiate new rulemaking to change a regulation to respond to new information or learnings, we will be again stuck with the decades-long political process of new legislation.

The same goes for all the state legislation – except multiplied by 50 (or more if you count city-state efforts of the likes of SF and NYC).  At least you can get changes a little faster in than Congress to fix things.

We’ll see….

Nice industry perspective articles from ICSIS.com here and here

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The Senate Committee on Environment and Public Works and Subcommittee on Superfund, Toxics, and Environmental Health voice voted (10 to 8) to send the latest version of the Senate Bill 847, Lautenberg’s “Safe Chemicals Act”  for floor vote.  Republicans are not happy and feel they’ve been locked out, but haven’t offered counter-language so the Dems are blowing them off.   Interestingly, Jim Jones, the EPA AA on TSCA, declined to state a position on the bill.  The likelihood of anything coming out of this Congress is slim to none.

The hearing held by Boxer on the 24th ended with her making the panel vote “yes” or “no” only on the question “Do you agree that chemical manufacturers should have to prove, through objective studies, that their products are safe for pregnant women, for infants and children before they can sell their products in the U.S.”  Not surprisingly, the industry reps declined to vote since she wouldn’t let them talk about function (e.g., pharmaceuticals) or risk – hazard and exposure (e.g., industrial intermediates, wine).  It’s this simplistic approach that makes changes to TSCA so challenging.

See previous blogs on TSCA Reform

A summary of changes published by Lautenberg(?) describes:

– allowing a lesser, screening minimum test set on new chemicals

– better prioritization via tiered batches of 6,000 chemicals over 5 year periods with three levels of concern – very low concern, need more info (minimum data set), and very high concern.

– Very High Concern (SVHC in REACH-talk) get expedited safety standards and risk management – which means they can issue administrative orders with no judicial review instead of that messy notice and comment rulemaking process.

– EPA is to rely on existing information first before requiring additional information/testing only to the extent necessary to determine safety.

– CDR is now detailed in law for processors – but only as necessary for implementation of the act and have value commensurate with the burden of reporting.  (At least there’s rulemaking.)

– “Safety” is still defined as “there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance.”

– Confidentiality is supposed to be a little easier to claim now.  There seems to be some convoluted language on allowing chemical identity to be protected for a limited time if the chemical isn’t carcinogen or other “-gen” or a PBT

Watch for my own “markup” later.  That will take awhile, as they’ve replaced 86 pages of the previous version with 174 new pages, making the total bill now 270 pages long – and that’s before anyone gets a chance to add in amendments on the floor.  

Special interests continue to write detailed instructions into law that are de facto regulations that then cause agencies to issue nanoscale detail in their regulations to be later “clarified” by the courts.  Whatever happened to setting goals and allowing experts work together to find the most efficient and effective way to achieve and enforce those goals? 

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Canada periodically puts out mandatory survey on batches of chemicals as it works through its prioritization process. For example in June there were 8 MDA/MDI chemicals of interest.  It’s a pretty comprehensive set of information demanded of manufacturers, importers and processors: volumes, uses available toxicity information and a list of the top 20 customers.  With the possible exception of getting customer lists, such information can be obtained under TSCA section 8 – basically CDR + 8(d) – applied to manufacturers, importers and processors.  

But note that Canada is only going after EIGHT chemicals in this notice – not thousands at a time like EPA does under CDR!  As Canada identifies categories of chemicals they are concerned about, they hold webinars and issue “mandatory surveys” – evaluate the information and go back for more if they need it (link).  Granted, they have far fewer companies and chemicals to cope with than the US, but note how they are being systematic about working through their inventory on a priority basis.

Maybe advocates for TSCA Reform are right – EPA needs the kick in the pants of legislative instructions to actually do something under TSCA.  The trouble is pick-a-number is pretty arbitrary.  But maybe that’s where we are at?  The Agency has had numerous initiatives – like ChAMP, HPV, Chemical Action Plans and now a “Work Plan” – but they always seem to run out of gas.  I still hold there is a ton of authority in the current TSCA for EPA to take action – especially if they tackle chemicals by category (section 26) and not try to do humungous every-test-known-to-man and/or ban-it-all regulations.

I’d certainly recommend looking to Canada as opposed to Europe as a model to emulate.

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Note the federal government new hires to write and support new regulations in the last year and a half.  Unfortunately, notice how all the states have to implement these new regulations and the thousands of companies who have to comply aren’t keeping up.  Maybe because the latter aren’t able to print money to hire new people (or consultants).  They have to reallocate resources to meet these new requirements.  Hopefully, employees and dollars are being pulled from less beneficial activities…..

from Investors.com article

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As follow on to its Chemical Action Plan on Bisphenol A (BPA), EPA published an Advance Notice of Proposed Rulemaking July 26, 2011, to develop environmental effects and exposure testing.  EPA is not addressing human health effects in this notice as there is ongoing testing work already with other agencies.  (See a pointed Trevor Butterworth blog about that work here.)

Related to my earlier blog on GLP, it’s nice to see the following acknowledgement regarding  effects “data” that has been generated by academia:

It is difficult to interpret this information in a regulatory context, because the scientific methods employed in individual academic settings to test a hypothesis are not necessarily geared toward meeting or establishing generally applicable guidelines for evaluating ecotoxicity and setting corresponding regulatory limits or controls. In terms of environmental toxicity, EPA considers the currently available research as evidence that BPA has the potential to interact with the estrogen hormone system.

In order to be useful to an investigation of potential environmental risks posed by BPA, environmental testing must be representative and of known quality. To accomplish this, data should be collected using approved or recognized sampling, preparation, and analytical techniques. Appropriate quality assurance and quality controls also should be incorporated in the protocols for collection and analyses.

EPA is soliciting comment on “whether and on what basis they believe the current data are sufficient to determine whether BPA does or does not present an unreasonable risk of injury to the environment.”  This is the threshold for a TSCA section 6 control regulation, whereas a section 4 test regulation requires only a “may present” hurdle.  So maybe the point is to skip any additional testing and go straight to a ban.  Sorry, EPA, get some good, reliable data first.

Not that there aren’t challenges to getting environmental monitoring data, especially when it’s off-site.  There should be some creative work done to figure out how to get manufacturers (and processors?) to pitch in to cover monitoring by EPA or some third party.  Yikes – do it through some sort of SIEF process?

Getting some quality, meaningful data to support risk evaluation and potential restrictions is a valid and doable Action Plan under today’s TSCA .

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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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