Document bBEkd3wBO47za89JqVB4nqgZ1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D C 20460 Mr. Michael P. Walls Vice President, Regulatory Affairs American Chemistry Council 700 Second St., NE Washington, D.C. 20002 JUN 1 9 2017 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION Thank you for your letter of March 23, 2017, regarding the pre-manufacture notices (PMNs) submitted to EPA by Qualice LLC, Dover Chemical and INEOS (now INOVYN Americas, Inc) pursuant to section 5(a) of the Toxic Substances Control Act (TSCA) on chlorinated paraffins. EPA has been reviewing medium-chain chlorinated paraffin and long-chain chlorinated paraffin chemicals as a result of consent decrees issued in 2012 between the Department of Justice and EPA and two companies. In a Federal Register notice published in December 2015, EPA requested any new data on certain chlorinated paraffins to inform EPA's risk assessments for the chlorinated paraffins submitted as PMNs. EPA has completed its risk assessments and the assessments were provided to Qualice, Dover, and INOVYN. EPA determined that the use of these chemicals may present unreasonable risks to the environment. EPA has decided to regulate the substances by issuing orders to allow manufacture pending the development of information pursuant to section 5(e) of TSCA. Most TSCA section 5(e) orders issued by the Agency are consent orders that are negotiated with PMN submitters. They contain conditions of manufacture to ensure that the use does not present an unreasonable risk to human health or the environment. T he orders also contain testing requirements. EPA met with these three PMN submitters on April 12 to discuss its risk determination and the specifics regarding the conditions of the consent orders. The consent orders, which contain use restrictions and recordkeeping requirements, and require certain testing within 5 years, were signed by EPA and sent to the companies on May 9 for their signature. All three companies have signed their consent orders and are now free to commence manufacture of their PMN substances. T esting conducted under the consent orders would provide information relevant to prioritization and possible risk evaluation under TSCA section 6. Again, thank you for your letter. If you have further questions, please contact me or your staff may contact Greg Schweer in the Chemical Control Division at schweer.greg@epa.gov or (202) 564-8469. Sincerely, Wendy Clelanu-Hamnett Acting Assistant Administrator Internet Address (URL) http //www epa gov Recycled/Recyclable Printed with Vegetable Oil Based Inks on 100% Postconsumer Process Chlorine Free Recycled Paper