TSCA Action Begins

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….


138 SVHC Now

There are now 138 Substances of Very High Concern under REACH with the addition of another set of 54 chemicals December 19, 2012.  Producers and importers of articles have 6 months to notify ECHA if articles contain more than 0..1% by weight and the use hasn’t already been registered.

Companies need to keep on top of new listings (about every 6 months) and be prepared to find out whether articles you make, sell or buy contain >0.1% adding to more than 1 metric tonne/yr.  You can also see what’s likely to come up by looking at the list of “intentions” to add to the Candidate list here.

Also track whether any of the chemicals reach the “Authorization” (14 so far) stage that will restrict use.

EHS Strategies, Inc. can help you with the implications for your company.

As expected, the direct final rule requiring reporting “health and safety studies” under TSCA 8(d) for anything with cadmium in it was too controversial.  EPA announced Dec. 14, 2012 [Federal Register notice published 12/28/12]:

On December 3, 2012, EPA published an immediate final rule requiring the reporting of existing and unpublished health and safety data for cadmium and cadmium compounds used in consumer products pursuant to section 8(d) of the Toxic Substances Control Act (TSCA). Based on several letters asking questions and raising concerns about the scope and extent of the immediate final rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule, EPA has decided to withdraw the immediate final rule and will sign a Federal Register notice announcing this decision no later than the January 2, 2013, effective date of the immediate final. EPA will be considering the questions and concerns raised in response to the immediate final rule and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children’s metal jewelry.

EPA appears to be trying to push the envelope of their TSCA authorities – which they should – but this was a tad too far for a direct final (no public comment) rule.

REACH Reality

Pointed comments by outgoing CEFIC (European Chemical Industry Council) president Squinzi on REACH here.  One highlight on the 2 billion euro cost since 2007:

“This is within the initial cost range for the whole of REACH, yet we have only passed through the first registration deadline. This points to two things: firstly, the costs are high; secondly, as smaller organizations enter the REACH processes we must find ways to eliminate all unnecessary costs. This can range from highlighting the big cost items and amending the legislation to simplifying the procedures at the implementation phase. Here, we look to the agency to review any activities which we’re not explicitly required by the legal text.”

EPA released its “Universe of Chemicals” of 10,000 chemicals that might be targeted for screening tests to determine whether they are endocrine disruptors over the next 5 years (it could have been 87,000).  From the report:

“It is important to emphasize that the identification of this universe of chemicals for potential EDSP screening should neither be interpreted as a list of chemicals that will automatically be screened, nor as a list of chemicals with potential to interfere with endocrine systems of humans or other species.”

The report also lays out validation principles that will be used on the screening tools (heavy on computational modeling):

1. a defined endpoint;
2. an unambiguous algorithm;
3. a defined domain of applicability;
4. appropriate measures of goodness-of-fit, robustness and predictivity;
5. a mechanistic interpretation.

and declares external peer review will take place in January 2013.

Pretty ambitious.

EPA has withdrawn this final rule as of Dec 14, 2012 – too controversial!


EPA today released a final rule  that requires reporting of “health and safety studies” under TSCA section 8(d) for cadmium and its compounds in consumer products.  This is a little broader than the lead rule that focused on children’s products (40 CFR 716.21(a)(8)).

Article Import and Manufacture: The rule applies to manufacturers and importers of cadmium, cadmium compounds or cadmium-containing ARTICLES  that have been, or are reasonably likely to be, incorporated into consumer products if any cadmium has been measured to be present.

consumer product means any product that is sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in or around recreational areas.”

Reportable “studies” appear to have been expanded beyond traditional toxicity and exposure studies to include:

– measurement of cadmium content in a consumer product

– discussion of the function of the cadmium and formulation

– migration from the product studies

The preamble implies the above are reportable as stand-alone data.  That’s not the way TSCA 8(d) reads: such data would only e reportable if it were developed as part of an exposure assessment or toxicity study.

As with the standard 8(d) model rule (40 CFR 716), this rule applies to anyone who manufactured or imported cadmium-containing consumer  products in the last 10 years and anyone proposing to do so in the future.

Timing:  The rule is effective 30 days after Federal Register publication unless someone complains, in which case EPA traditionally withdraws the “direct final” rule and publishes a proposed rule for comment.  Expect there to be comment.  Once final, you have 60 days to send in unpublished studies in your possession and 30 days to notify EPA of future studies.

This stems from EPA’s work with CPSC to reduce cadmium exposure.

Contact EHS Strategies, Inc. for assistance.

FTC Green Guides

Reminder that FTC has issued new guides for environmental marketing claims: http://www.ftc.gov/os/2012/10/greenguides.pdf

There are more examples and terms explained, but it still comes down to two basic principles:

1. Be technically accurate

2. Do not mislead

That last one is the challenge.  You have to follow public and customer understanding of what they think terms mean and cool it with the “green” art.  We’ll see if FTC steps up enforcement.

Interestingly, GreenBiz posted a couple articles Nov 19.  Getting the word out on how to more careful with claims is good.