The Polymer Exemption

The advantageous regulatory position, which, due to the polymer exemption , simplifies the protocols for the introduction of new products to the market... 

Historically, only the used calculation for the concentration of a precursor was available but, in 1995, the incorporated calculation was added. Where the percent incorporated can be determined and supported by analytical results, this method of calculation can lead to a lower percentage of certain reactants for decision-making instead of using the calculation for the percent used. A new polymer may also be chemically identical to an existing polymer based on the degree of the precursor s incorporation. One may suppose that under the polymer exemption promulgated in 1995, the two-percent... 

One situation that may not be entirely clear is whether a polymer that was initially manufactured under the polymer exemption with a given monomer or reactant used or incorporated at greater than 2 wt% is the same polymer under the exemption if the same monomer or reactant is subsequently used or incorporated at a concentration that is equal to or less than 2 wt%, but greater than 0 wt%. Based on EPA guidance, it would appear that the subsequent version of the polymer as just described would be the same polymer under the exemption as the initial polymer. In the Guidance Document, the EPA states that ... 

The regulatory benefit of meeting the polymer exemption requirements is that a PMN under TSCA Section 5 need not be submitted to the EPA before starting commercial manufacture or importation of a polymer that is not on the TSCA Inventory. Only a one-time notice must be sent to the EPA indicating that the company has used the polymer exemption, and this brief notice need not include the chemical identity of the polymer. 

In Canada, polymers are defined under the CEPA in the same manner as they are in the EU and under the polymer exemption in the US, but the regulatory implications are different. In Canada, all types of new polymers (those not present on the DSL) must be notified (unless manufactured or imported in certain small quantities), unlike the general exemption in the EU or the specific polymer exemption in the US. As mentioned previously, meeting the polymer definition in Canada allows the substance to be notified as a polymer and not a chemical, which reduces the amount of test data and other information that must be submitted. Therefore, it is critical that a substance be carefully analysed, particularly for molecular weight distribution, so that its notification in Canada as a polymer is validated. 

Other factors used to determine if a polymer meets the RRR criteria are similar to those used in the determination as to whether a substance qualifies for the polymer exemption in the US, but subtle differences exist. Eor example, in the US, if one of the reactants used at greater than two weight percent to manufacture a polymer is not on the TSCA Inventory or covered by an applicable Section 5 exemption, this fact alone will disqualify the polymer from meeting the polymer exemption criteria. In Canada, such a situation would not disqualify a polymer from being considered to be RRR, although the reactant s presence on the DSL does affect which Schedule of data must be submitted. 

Perhaps the polymer exemption approach in the US under the TSCA comes closest to striking a balance between the overly lenient approach in the EU and the overly conservative approach in Canada. The molecular weight requirements and restrictions on reactive functionalities and certain physical attributes defined under the exemption go a long way toward defining a better way of regulating polymers. This approach could resolve the legal issue under REACH involving the requirement that monomers in reacted form in polymers... 

The two percent rule also defines how broadly Inventory listings of polymers may be interpreted. The second place it makes its appearance is in the polymer exemption rule where it is used as part of the definition of polymers exempt from the PMN requirements of TSCA 5. °... 

Is the substance exempt from coverage under the PMN program because of a self-executing exemption such as the R D exemption or the polymer exemption If it is exempt pursuant to a self-executing exemption, no PMN is necessary. 

These polymers are eligible for the polymer exemption, but companies have the option of filing PMNs for them. http //www.epa.gov/oppt/newchems/pubs/hmwtpoly.htm... 

The United States Environmental Protection Agency (EPA) has authority under the statute to grant additional exemptions under TSCA 5(h)(4) if the manufacture, processing, distribution in commerce, use or disposal of a substance will not present an unreasonable risk of injury to health or the environment. Several exemptions have been promulgated under this authority, including the polymer exemption, the LVE and LoREX exemptions, and the Polaroid exemption. 

There is a pending rulemaking to require certain classes of polymers with perfluorinated units—polymers in which fluorine atoms are substituted for the hydrogen atoms that are present in many polymers—to go through the PMN process. The proposed rule would make the polymer exemption unavailable for these polymers because, as the EPA explained in its proposed rule, the EPA could not assume that all such polymers are risk-free. The EPA cited liver, developmental, and reproductive toxicity at very low exposure levels as well as data that indicates that some perfluorinated polymers maybe carcinogens. These generalizations have been criticized by the chemical industry. ... 

The polymer exemption is an exemption from the premanufacture notice requirements and not an exemption from all of the many programs under the Toxic Substances Control Act. An exempt polymer is subject to all of the other TSCA programs, including (but not limited to) the substantial risk reporting in 8(e) of the statute, Significant New Use Rules, import certifications, and export notifications. 

The first condition for the polymer exemption is that the substance must meet the definition of a polymer stated in the exemption, which is not the same as a chemist s definition of a polymer. This regulatory definition is also not the same as the definition the EPA uses for Inventory purposes, andis just a small subset of that much broader definition. To keep all of the different... 

The second condition for the polymer exemption is that the substance cannot be specifically excluded. In practical terms, this means that once a person determines that the substance meets the definition of polymer, he or she must also check the list of exclusions to be certain that the substance is not excluded from the polymer exemption. If the substance is excluded, then no one can manufacture or import it without going through the PMN process. 

Cationic polymers must go through the PMN process, with two exceptions. The first exception is for solid polymers that are not dissolved or dispersed in water, and are only used in the solid phase. Ion exchange materials are examples of these cationic solid polymers that do qualify for the polymer exemption. The second exception is for polymers that are large compared to the number of cationic groups. If the combined functional group weight of... 

Polymers that have elements outside of ranges in 40 C.F.R. 723.250(d)(2) are excluded from the polymer exemption, and anyone who is going to manufacture them or import them must file a PMN if they are not already on the Inventory. This exclusion requires that a polymer that qualifies for the polymer exemption must ... 

No other elements can be present, so, for example, a polymer may not have any boron, any fluoride ions, or more than 0.20 weight percent of Hth-ium as an integral part of its composition and still qualify for the polymer exemption. 

Even if a polymer does degrade, it can stfll qualify for the polymer exemption if the manufacturer can restrict the uses to those where degradation will not take place. The EPA addressed an example of a polymer that has two uses in one use it breaks down in water, but in the other use it is incorporated into a solid article that is not expected to break down. The EPA said that if the manufacturer can ensure that the polymer is only used as part of an article that is not expected to break down, then the polymer will qualify for the polymer exemption. As a practical matter, if the manufacturer is distributing the polymer to other end users, it is probably relatively more burdensome to enter into and enforce contracts restricting the use of the polymer than it would be to file a PMN. Filing a PMN certainly exposes the manufacturer to less risk of violating the TSCA regulations. 

See Chapter 3, The Inventory. Note that the polymer exemption for polyesters does not disregard starting materials that are charged or present at less than two percent. Polymer Exemption Guidance Manual, 43 (question 37). 

Once a polymer has met the polymer exemption definition of polymer, and is not specifically excluded from the polymer exemption, it still must meet one of the three criteria contained in the regulations to qualify for the polymer exemption. 

The EPA noted that there are several classes of organic polymers that are included in the polymer exemption because they only have these low-concern reactive functional groups. The Polymer Exemption Guidance Manual says ... 

While a company is evaluating whether a polymer quaUfies for the polymer exemption, the company must follow the rules for the R D exemption from premanufacure notice requirements if it has not filed a PMN and an NOG... 

Once a company has done enough research to conclude that a polymer it manufactures falls within the polymer exemption, it must follow the recordkeeping and reporting requirements set out in the polymer exemption." ... 

The reporting requirements in the polymer exemption require each manufacturer and importer to mail a report to the EPA by January 31 of each year providing information on each polymer that it has manufactured or imported for the first time during the previous calendar year. A company may submit a report for each plant site or one consolidated report for the entire company, but should not duplicate information if it submits one report for each plant site." The report must include the following information ... 

The EPA uses these letters to determine what plants to audit for compliance with the polymer exemption, and to track how often companies rely on the polymer exemption. 

In addition to submitting information to the EPA, the manufacturer or importer must keep records of all the polymers it has made or imported in reliance on the polymer exemption. The manufacturer or importer must... 

In addition, the manufacturer or importer must create and maintain a certification stating that the polymer is made for a commercial use other than R D, that it meets the regulatory definition of a polymer, that it is not excluded by any of the exclusions to the polymer exemption, and that it meets one of the criteria for the exemption. The certification must also state that the certification itself is truthful. ... 

The polymer exemption had originally grown out of a petition filed by the Chemical Manufacturer s Association (now called the American Chemistry... 

Examples of analytical methods are given in the regulations and in the Polymer Exemption Guidance Manual. 

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