January 27, 2009
Previously published on December 23, 2008
The United States Environmental Protection Agency (USEPA) recently issued new rules that will have a significant effect on the manufacturing and importing of certain chemical substances containing nanoparticles. Under the Toxic Substances Control Act (TSCA), USEPA has the authority to require reporting, record-keeping, testing requirements, and restrictions relating to chemical substances. Under Section 5 of TSCA, chemical manufacturers are required to file premanufacture notices (PMNs) to USEPA before manufacturing a chemical that is not already included in the TSCA inventory.[1] In the October 31, 2008 Federal Register, USEPA clarified that it considered carbon nano-tubes to be chemically distinguishable from conventional carbon compounds, therefor requiring PMNs.[2] As part of a PMN submission, a manufacurer is required to produce all available data on the chemical identity, production volume, byproducts, use, environmental release, disposal practices, and human exposure.[3] After a PMN is properly submitted and reviewed by USEPA, USEPA may allow the chemical substance to be manufactured or imported without restriction, impose specific conditions on the manufacturing or importing of the chemical through a Consent Order, or completely prohibit any manufacturing or use of the substance.[4] Any restrictions imposed through Consent Orders are only binding on the original PMN submitter that manufactures or imports the substance. Consequently, after signing a Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors of the same material(s) to the terms and conditions contained in the Consent Order. In the November 4, 2008 Federal Register, USEPA issued SNURs for 56 chemicals, including two nanoparticles.[5] The generic names of the two nanoparticles covered by the SNURs are siloxane modified silica nanoparticles, PMN No. P-05-673 and siloxane modified alumina nanoparticles, PMN No. P-05-687.[6] Under the SNUR, a party must notify EPA at least 90 days prior to manufacturing, importing or processing the nanoparticles for any of the following uses: (1) use without impervious gloves or a NIOSH-approved respirator; (2) the manufacture, process, or use of the nanoparticles as a powder; (3) or uses of the nanoparticles that are different than the uses described in the previously submitted PMNs.[7] The SNURs will take effect on January 5, 2009 if the USEPA does not receive adverse public comments.[8] As a result of these USEPA actions, companies that are currently manufacturing or importing products containing nanoparticles should evaluate their activities to determine whether they are using either of the two listed nanoparticles, and if so, whether they are required under the new regulations to take action. Companies using other nanoparticles should be aware that future regulation is likely, and be on the alert for additional determinations from USEPA.
[1] 15 U.S.C. §2607(b)(1)
[2] 73 F.R. 64946 [3] 15 U.S.C. §2604 [4] Id. [5] 73 F.R. 65743 [6] Id. [7] Id. [8] Id.
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