Consolidation of PMN Submissions Frequently Asked Questions
1.Q. Is there an abbreviated procedure for submitting PMNs on structurally related new chemical substances?
A. The Agency procedure for consolidation of PMN notices allows submission on up to six substances with similar use, structure, and probable toxicology at the same time and for the same fee as a single substance. This procedure benefits submitters, as it reduces the administrative burden of developing multiple PMN forms for manufacture of two or more structurally related new chemical substances which have similar use, exposure, environmental release, and test data. The procedure is also of benefit to the Agency, when all of the submissions would have come in separately, as it enables savings in the review process by looking at similar substances at the same time.
Persons who intend to submit a consolidated notice must contact the Prenotice Coordinator (202-564-9373, 202-564-9262, or 202-564-0883) for approval before submission of the notice. The Prenotice Coordinator will determine if the criteria for consolidation are met.
In the consolidated notice, the submitter must identify new chemical substances individually by submitting a separate chemical identity page for each new chemical substance, and each identification must be supported by a separate report from the CAS Inventory Expert Service. When other pages of the section 5 submission form differ between the substances in the consolidated submission, they should be submitted separately as well (generally identified as, e.g., page 4a, 4b, 4c, etc). This is not an abbreviated procedure: the 90-day statutory period applies for consolidated PMNs as it does for unitary ones.
2. Q. Where is the consolidated PMN described in the Federal Register or in what other publications?
A. The Agency announced a policy that it would accept submission of consolidated notices, subject to the approval of each submission by a Prenotice Coordinator, in the preamble of the May 13, 1983 Federal Register (Part III (C)(1)(b), p. 21734-35) and discusses procedures for acceptance of consolidated notices in Section II (E) of the Instruction Manual for Premanufacture Notification of New Chemical Substances.
At the time the Agency first allowed consolidations 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 of 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 the Prenotice Coordinators do 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.
3. Q. Why must a submitter get a name from the Chemical Abstracts Service Inventory Expert Service (CAS-IES) for each member of a consolidation? Often if one name has been bought from the Inventory Expert Service, the others can be figured out easily, and the additional reports from the IES are just an added expense to the submitter.
A. The Prenotice Coordinators will not approve any consolidated submission which 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 which have been previously examined by non-IES CAS personnel.
Information on the IES service including available resource materials is available via telephone (800-848-6538 ext. 2308) or by fax (614-447-3747).
4. Q. How should a new chemical which exists, in aqueous solution, in equilibrium with a "similar species" (also a new chemical) be reported on the PMN form?
A. If you have structurally-related substances in the situation described above, you will likely be given permission to submit a consolidated PMN notice (contact a Prenotice Communications Coordinator for a PC number.) Such a "one-pot" material can also be reported as a Class II chemical substance, if there is no intent to sell any of the components separately.
5.Q. Production of a series of metal salts of a modified organic acid is intended; does each salt require a PMN or can the entire series be declared in one PMN?
A. If each salt is intended to be isolated, individual PMNs (and, later, Notices of Commencement) are required. It may also be possible to submit a consolidated PMN for up to six such salts. Consult a Prenotice Communications Coordinator for assistance.