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Substances Consolidation Limitations

At the time the Agency first allowed consolidations (May 13, 1983, 48 FR 21734), it set no limit on the number of substances that could be submitted at the same time. Agency experience since that time has been that the rate of commencement of substances that were submitted in consolidations that included large numbers of substances was low; examination of commencement rates showed a drop in rate of commencement above six substances per submission.

A consolidation, though less demanding of Agency resources than the same number of separate submissions of related chemicals, still calls forth a substantially increased Agency effort over the assessment of a singular submission. Thus, in the case of a consolidation, which represents a substantial savings in fees and preparation time to a submitter, EPA has decided that it is appropriate simply to require a Method 1 submission for each member substance, and Prenotice Coordinators will not approve submissions for seven or more substances. The limitation on number of substances has been announced in several handouts from the New Chemicals Program and is discussed in this document and in the Instruction Manual.

EPA will accept no consolidated submissions that do not give CAS-IES names for each substance.

The Agency encourages, but has not required, that any single submission be named by Method 1. The Prenotice Coordinators will not, however, approve any consolidated submission that does not include a CAS-IES name for each substance included. Sources other than the IES have, overall, a higher error rate in generating names, and this specifically includes submitters making additional names by analogy to that of one member of an approved consolidation. When a submission has come in incorrectly named, the process of declaring it incomplete and returning it to the submitter diverts EPA resources from other important work of the New Chemicals Program. The Method 1 requirement for consolidations is not satisfied by simply giving a CAS name and number for substances that have been previously examined by non-IES CAS personnel.

 


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