A Practical Understanding of the Polymer ... - Keller Heckman

Introduction
determination of eligibility is on slippery, steep ground. Our advice: polymers
whose identities and relevant characteristics cannot be sufficiently defined should
be presumed to be ineligible for the exemption.
Once a polymer is sufficiently defined, its eligibility may be determined. If
eligible, the new polymer can be manufactured or imported immediately. Where
applicable, this can be an immense benefit. However, by exempting certain polymers
from premanufacture review, the EPA has given the responsibility of certification
for this eligibility to individuals in businesses. At first glance, this burden may
seem less than it actually is.
In addition to recordkeeping, a one-time report is required for each polymer
manufactured or imported under the exemption. Manufacturers and importers of
the exempt polymers must report the number of polymers that have been commercialized.
This can be done for each site of manufacture or import, or this report can
be consolidated into a single report for the manufacturer or importer. Consolidation
should avoid duplicate reports for the same polymers. The EPA must receive this
report by January 31 of the year following the calendar year in which the polymers
were introduced into commerce under the exemption for the first time. Note that
only the number of polymers per site or per manufacturer is reportable; the chemical
identity of those polymers should not be reported.
Preparing an accurate report will be impossible unless one can validly distinguish
one polymer from another. Such discrimination is difficult because manufacturers
can create polymers with vastly different properties that, under TSCA, the
EPA considers the same polymer. One the other hand, manufacturers can produce
polymers that are differentiated under TSCA even though they consist of essentially
the same molecules. The problems of discrimination and identification can be
more difficult when polymers are manufactured from other polymers. Implicit prerequisites
that arise from the recordkeeping and reporting requirements are (1) to
establish the chemical identity of the polymer; and (2) to confirm that the identity
of the polymer is unique compared to other polymer identities for which you previously
have invoked the exemption.
In 1997, the EPA published a guidance document for the 1995 polymer exemption.
2/ This guidance states that it does not supercede any provision in the amended
polymer exemption rule, but there is a significant change in the reporting provision
known as the “two-percent rule.” There is no specific support for this belated guidance
in the polymer exemption itself. Prior to the publication of the guidance, one
could not anticipate this change, which is discussed in more detail below.
As a final introductory comment, we note that the lure of eligibility under the
polymer exemption is, perhaps, its greatest potential liability. Because the exemption
allows immediate manufacture of an eligible polymer, there is a moral hazard
that the internal review will be inadequate. If an error is made, another internal
certification can be quickly made. Perhaps that certification will be correct. Surely
a series of errors is an unintentional result of relaxed qualifications for the polymer
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