May 12, 2017
Commercial Chemical Products vs. Manufactured Articles
People often get confused in determining whether a product to be disposed is a commercial chemical product, to which the P- and U-codes apply, or a manufactured article, to which they don’t. So, what’s the difference?
Commercial chemical products
In the comment included in §261.33(d), EPA notes “The phrase ‘commercial chemical product or manufacturing chemical intermediate having the generic name listed in…’ refers to a chemical substance which is manufactured or formulated for commercial or manufacturing use which consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed, and all formulations in which the chemical is the sole active ingredient….” Thus, unused pesticide containing 0.1% carbaryl as the sole active ingredient is U279 if disposed.
Manufactured articles
One of the most common errors in applying the P- and U-codes is that generators evaluate an unused product, find that it contains one or more of the listed commercial chemical products in §261.33(e–f), and then assign the associated hazardous waste code(s) to the product when they are getting ready to discard it. In general, EPA would term these objects “manufactured articles” and regulates them as follows:
“Manufactured articles that contain any of the chemicals listed [on the P- or U-list] are rarely, if ever, known by the generic name of the chemical(s) they contain and, therefore, are not covered by the [P- or U-] listings.” [November 25, 1980; 45 FR 78541]
Thus, unused wool blankets that were treated with DDT are manufactured articles containing DDT (which keeps moths from eating the blankets) and would not be U061 when disposed.
New guidance
EPA recently provided additional guidance to differentiate between commercial chemical products and manufactured articles in RO 14887. In that guidance, the agency noted that manufactured articles, such as batteries, fluorescent lamps, and thermometers, are all designed for a purpose other than to access the chemicals that are present in these articles. Specifically, one uses these articles for electrical energy (batteries), for light (lamps), or to measure temperature (thermometers). One does not use these articles in order to access the mercury or lead or other chemicals contained in them.
EPA then applied this additional interpretation of what constitutes a manufactured article in RO 14887 to a medical device that delivers nitric oxide (NO) therapy to patients. When the device is activated, an ampule containing liquid dinitrogen tetroxide (N2O4) is broken, releasing nitrogen dioxide (NO2) gas. The NO2 is then converted to NO while it passes through tubing that contains a catalyst. The agency noted the following in this guidance:
- Pure, unused NO2 is P078 when discarded. In addition, the liquid N2O4 dimer is also included within the P078 listing because N2O4 forms when NO2 gas is compressed. The device contains commercially pure or technical grade compressed NO2 gas within the glass ampule, which is also the sole active ingredient. Therefore, if the glass ampule is not broken, then the unused device containing the compressed NO2 is a commercial chemical product and is regulated as P078 when discarded. This situation may occur if inventory expires or exceeds its shelf-life and is disposed.
- The unused device would not be a manufactured article, because a patient/individual specifically intends to access the chemical inside the device.
- If the device is used as intended, the used device is not regulated as a listed hazardous waste when discarded. This is because once the glass ampule has been broken, the device reaches atmospheric pressure and meets the definition of RCRA-empty, as defined in §261.7(b)(2).
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This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.
