Consolidation of PMN submissions
- EPA will only charge a fee equal to that for a single submission for a consolidated submission of up to six chemical substances.
- Pre-approval before a PMN is submitted is required for a consolidated submission.
When a potential chemical manufacturer wants to submit premanufacture notices (PMNs) on several (up to six) closely similar substances, there are economies for the Environmental Protection Agency (EPA) in reviewing them together. In recognition of these economies and to encourage manufacturers to submit such PMNs together, the agency will only charge a fee equal to that for a single submission for a consolidated submission of up to six chemical substances.
Pre-approval before a PMN is submitted is required for a consolidated submission. The chemical manufacturer should contact the New Chemicals Prenotice Coordinators for consolidation approval. Approval will be given if the substances are adequately similar chemically and toxicologically, if the planned uses are similar enough for combined review, and if intended volumes are not excessively different. Approved consolidations will be given a prenotice communication number, which must be entered on the section 5 submission form. In some cases, a synthetic sequence can be consolidated, as well.
EPA encourages, but has not required, that any single submission be named by Method 1 (see 720.45(a)(3)). The Prenotice Coordinators will not, however, approve any consolidated submission that does not include a Chemical Abstracts Service (CAS) Inventory Expert Service (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.