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

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<strong>Polymer</strong> Exemption Requirements<br />

10<br />

not qualify any o<strong>the</strong>r version <strong>of</strong> <strong>the</strong> same polymer if it is water-absorbing. In short,<br />

<strong>the</strong> exclusion must never be violated by any version even if some versions satisfy<br />

this limitation.<br />

If possible, determine <strong>the</strong> dry mass <strong>of</strong> a sample <strong>of</strong> <strong>the</strong> polymer in question that<br />

is free <strong>of</strong> precursors and o<strong>the</strong>r associated substances. Then contact <strong>the</strong> sample with<br />

a quantity <strong>of</strong> water equal to twice <strong>the</strong> polymer’s dry mass. We suggest using normally<br />

available, deionized water. Record <strong>the</strong> pH <strong>of</strong> <strong>the</strong> water used to establish that<br />

<strong>the</strong> pH is within <strong>the</strong> usual bounds <strong>of</strong> neutrality. Reasonable conditions during <strong>the</strong><br />

contact would be one hour at room temperature. The nature <strong>of</strong> <strong>the</strong> contact should<br />

be such that <strong>the</strong>re is a reasonable opportunity for <strong>the</strong> polymer to absorb <strong>the</strong> water.<br />

Subsequently, physically separate <strong>the</strong> wet polymer from excess gross water.<br />

Determine <strong>the</strong> mass <strong>of</strong> <strong>the</strong> polymer plus whatever mass <strong>of</strong> water that has been<br />

absorbed and retained. If this wet mass is less than double <strong>the</strong> dry mass or more,<br />

<strong>the</strong> polymer is not sufficiently water-absorbing to be excluded from <strong>the</strong> exemption<br />

by this provision.<br />

The EPA has not considered how time, temperature, pH, water purity, apparatus,<br />

procedure, nature <strong>of</strong> <strong>the</strong> polymer, interpretation <strong>of</strong> data, kinetics, or o<strong>the</strong>r considerations<br />

will influence <strong>the</strong> results. If <strong>the</strong>re is significant water absorption, it might be<br />

prudent and appropriate to submit a suitable protocol and data to <strong>the</strong> EPA for<br />

approval before relying on any particular results.<br />

6. Reactive Functional Groups<br />

A reactive functional group (RFG) is defined as an atom or associated group <strong>of</strong><br />

atoms in a chemical substance that is intended or can be reasonably anticipated to<br />

undergo fur<strong>the</strong>r chemical reaction. This provision is expressed in <strong>the</strong> regulation as<br />

a limitation to <strong>the</strong> (e)(1) condition, not as an exclusion. Although <strong>the</strong> reactive functional<br />

group limitation it is not applicable to <strong>the</strong> (e)(2) and (e)(3) conditions, it<br />

might be better understood as an exclusion, albeit one that only applies to (e)(1).<br />

There was an RFG exclusion in <strong>the</strong> original polymer exemption. In <strong>the</strong><br />

amended exemption, <strong>the</strong> RFG exclusion, like <strong>the</strong> entire exemption itself, is more<br />

complex compared to <strong>the</strong> original version. None<strong>the</strong>less, it allows more polymers to<br />

be exempt.<br />

More polymers are potentially exempt due to both <strong>the</strong> exclusion’s sole applicability<br />

to <strong>the</strong> (e)(1) condition and o<strong>the</strong>r complicating refinements. In fact, <strong>the</strong><br />

refinements can be extremely complicated if one has different kinds <strong>of</strong> RFGs present<br />

in <strong>the</strong> polymer’s molecules. A “quick and clean” approach is to identify <strong>the</strong><br />

equivalent weight for all RFGs that will form an ionic or covalent linkage to an<br />

amino acid. If that equivalent weight is less than 5000 for all such groups combined,<br />

<strong>the</strong> polymer is probably excluded by this provision, but <strong>the</strong>re is hope that it<br />

is not excluded unless <strong>the</strong> equivalent weight is less than 1000.<br />

The (e)(1) limitation only applies when <strong>the</strong> polymer’s molecular weight is<br />

1000 or more, but less than 10,000 and <strong>the</strong> oligomer levels are less than 25 and 10

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