Tuesday, April 3, 2012

ECHA Updates REACH Guidance on Data Sharing for Chemical Regulation

The European Chemicals Agency (ECHA) has updated its guidance on data sharing.  The update takes into consideration information and experience obtained during the REACH registration process and since the original publication of the guidance in 2007.

According to ECHA,"the text has been throroughly revised amending both content and structure." Changes to content include improvement of the "overall coherence" and to create a more focused document that helps companies avoid "unnecessary testing." Duplicative material covered in other guidance has been removed and/or made more consistent.  Two new sections have been added to make the document clearer, including more comprehensive discussions of the data sharing process for phase-in and non-phase-in substances. Additional new sections cover the "data sharing dispute processes" and "post-registration data sharing obligations."

More information can be found on the ECHA site.

Monday, April 2, 2012

EPA to Decommission Important Chemical Identification Tool Due to Lack of Funding

The USEPA has announced that it will soon decommission an important chemical identification tool "due to lack of funding support." The Analog Identification Methodology (AIM) tool was "designed to help identify publicly available, experimental toxicity data on closely related chemical structures."  Once decommissioned, AIM will no longer be available on EPA's website.  Funding to EPA has been severely cut by Congress 9with threats of even more cuts) for a variety of programs designed to protect health and safety of humans and the environment. 

AIM has been a valuable tool for industry to identify chemicals that are similar to the ones for which they are filing PreManufacture Notices (PMN).  PMNs are filed prior to putting a new chemical on the market.  Without the AIM tool industry will have less certainty as to whether they have provided the proper information to ensure an efficient approval process.  Under TSCA, EPA has 90 days to inform industry if their PMN raises concerns for the new chemical; without concerns being raised the submitter is allowed to put the chemical into production after the 90 days.  Without use of AIM as a screening tool there is a potential for more concerns to be raised in order to give more time to review the PMN.

EPA is asking all those in industry, NGOs, and consultants who use the AIM tool to email coordinator Kelly Mayo-Bean (mayo.kelly@epa.gov) with a note indicating their use of the the tool and its importance in their work.  Ms. Mayo-Bean will compile comments and provide to management in hopes of having the funding and tool reinstated in the future.