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Posts Tagged ‘action plans’

Draft risk assessments have been announced by EPA under their new Work Plan to begin tackling 83 chemicals.  These are open for public comment and will be peer-reviewed.  EPA may or may not take action to restrict uses under TSCA after the assessments are completed.  In the meantime, the press release says:

“EPA recommends the public follow product label directions and take precautions that can reduce exposures, such as using the product outside or in an extremely well ventilated area and wearing protective equipment to reduce exposure.”

– even though the draft risk assessment says there is no concern for ATO and HHCB.

The chemicals are assessed for risks based on consumer products uses:

methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint stripper products – potential concern for human health acute and chronic risks

trichloroethylene (TCE) as a degreaser and a spray-on protective coating – potential concern for human health for  small commercial and hobbyist degreaser users

antimony trioxide (ATO) as a synergist in halogenated flame retardants – low human exposure, low concern for ecological health

1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products – negligible human health risks of concern, low concern for ecological health

Read the detailed reports here.

 

EPA says it will get aggressive in using existing TSCA authorities on the assumption legislative TSCA reform isn’t going to be resolved this Congress.  We’ll keep watching….

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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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REACH has it’s CoRAP (Community Rolling Action Plan) list and now EPA has a Work Plan list of 83 chemicals selected under a new prioritization scheme.  Read all about it here.  They seem to have dropped the “Action Plan” lingo.  Now they are looking at 7 hot chemicals for 2012:

  • Antimony and Antimony Compounds
  • HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta[g]-2-benzopyran)
  • Long-Chain Chlorinated Paraffins
  • Medium-Chain Chlorinated Paraffins
  • Methylene Chloride
  • N-Methylpyrrolidone
  • Trichloroethylene

Where will the agency go with the boatload of priority chemicals – who knows?  Reporting rules under section 8, test rules under section 4, “voluntary” market deselections, dreaded section 6 control rules….  There’s a ton of authority under TSCA to do something today if they’ll actually work the plan and not go crazy trying to ban them all.   WIll companies raise a ruckus?  You bet. So what?

Let the rulemaking begin!

 

EHS Strategies, Inc. can help you figure out what to do if your chemicals are on the list.

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EPA is holding a webinar on how they are going to prioritize chemicals under TSCA Sept 7, 2011, 1:30 – 3:30 pm EST. Register here.   Apparently they heard the message that their picks of chemicals of concern for “action plans” were pretty random.  Will this be a recast of ChAMP?

Get background and blog on the topic with EPA here until Sept 14.  This seems more a focus on data sources than the actual assessment and prioritization process itself, however.  The devil is always in the detail and weighting of factors and just how large a collection of chemicals EPA intends to tackle and how.

Once upon a time, I helped develop a model with the then Chemical Manufacturers Association on how EPA could prioritize chemicals based on a separatory funnel filled with red, yellow and green chemical-application entities (represented by jelly beans in an actual sep funnel).

(c)1996, Chemical Maufacturers Association Product Risk Management Strategy Overview

We argued that EPA should focus on the highest likely risks (worst first) – the red chemical-application/use combinations (red dots).  The factors EPA lists in the background paper are “red,” although it’s not clear they are talking risk as in exposure + toxicity, rather than stand alone criteria: children’s products, PBT, developmental effects, carcinogens.  But key to the concept of the sep funnel was that EPA should titrate (tackle) red dots (high potential risk chemical-applications) only at the rate it could manage through its regulatory processes.  As it screened and addressed chemical risks, it could  titrate out some more chemical-use applications.  Of course, the Jackson EPA is into issuing blacklists of chemicals and publishing industry reported data (the new CDR with difficult CBI claims) to enable NGOs to exert pressure on companies to eliminate chemical use, so EPA can avoid writing regs.

We even went so far as to draft the reporting elements of a “red dot reporting rule” – focused on toxic  chemicals that would likely be highest risks according to exposure filters.  At that time (mid-90’s), we were trying to avoid threatened massive IUR reporting. Fifteen years later, we get the Chemical Data Reporting Rule – without the filters, so we’ll have a lot of yellow and green chemical dots being reported on – with EPA still not sure how it’s going to prioritize chemicals.  Sigh….

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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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MDI and TDI are the latest chemicals announced for EPA “Action Plans” under TSCA.  The focus will be on these isocyanates used in products where consumers and/or the general public could be exposed to uncured chemical, which could result in dermal and inhalation sensitization and distress.

Plans are to use the various authorities under TSCA to collect information (8(c) and (d)) records of allegations of adverse effects and health studies), require monitoring tests to determine exposure levels (section 4), Significant New Use Rules (section 5(a)(2)), and possibly restrictions (section 6).

These are known workplace toxins with an array of required industrial hygiene protective measures.  Whether they are a public hazard is certainly worthy of exploration and, if necessary, some measure of control.  Certainly TSCA currently offers EPA the authority to explore the issue.  We’ll have to watch what EPA does with the information it collects.

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EPA has just posted its draft Alternatives Assessment Methodology on how it will compare the hazards of alternate chemicals in deciding whether or not to designate a product as “Designed for the Environment.”    DfE is geared to identifying alternatives that work and are available and are greener than the current chemicals that are being used.  The methodology guide offers how to classify hazards as very high-high-moderate-low and has many useful resources for those of you trying to decide which alternatives are “safer.”  EPA will be using alternatives analysis when looking at safer alternatives for the Chemical Action Plan priority chemicals.

The related GCI-NSF proposed standard “Greener Chemical and Process Information” identifies the same kinds of hazard elements, in addition to other process-related information, that a customer would use to compare alternate sources for the more “green” or safer product.  See blog

Product stewards can use this as a tool when designing or redesigning their own products.  I’m less concerned at where EPA is drawing the lines between very high-high-moderate-low as the importance of comparing alternatives and going with those that work the best for your business and have the best safety profile.

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