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Posts Tagged ‘reporting’

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On December 3, 2012, EPA published an immediate final rule requiring the reporting of existing and unpublished health and safety data for cadmium and cadmium compounds used in consumer products pursuant to section 8(d) of the Toxic Substances Control Act (TSCA).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.

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EPA has withdrawn this final rule as of Dec 14, 2012 – too controversial!

ATTENTION ARTICLE MAKERS!

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.

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