Questions & Answers for the New Chemicals Program
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Note: Effective January 19, 2016, PMNs must be submitted electronically. Learn more about the new e-PMN requirements. Questions & Answers for the New Chemicals Program (Q&A) U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics Washington, DC 20460 2004 -1- TABLE OF CONTENTS Page 1. GENERAL PROGRAM INFORMATION 100. General ............................................................................................................ 1-1 101. Guidance for Completion of §5 Submission Form ......................................... 1-6 102. Inventory Searches/Bona Fides ....................................................................... 1-17 103. Chemical Identification ................................................................................... 1-22 104. Nomenclature .................................................................................................. 1-26 105. Inventory Issues ................................................................................................ 1-31 106. Review Process ............................................................................................... 1-31 107. Notice of Commencement .............................................................................. 1-33 108. User Fee .......................................................................................................... 1-35 109. Consolidated Notices ...................................................................................... 1-39 110. Joint Submissions ........................................................................................... 1-41 111. Toll Manufacturer ........................................................................................... 1-42 112. Foreign Supplier .............................................................................................. 1-43 113. Trade Mark Reactant (TMR) Supplier ............................................................ 1-43 114. Analytical Method Recommendations ............................................................ 1-44 115. Test Data Requirements .................................................................................. 1-45 116. Environmental Fate Data ................................................................................ 1-50 117. Health and Safety Data ..................................................................................... 1-50 118. Ecotoxicity Data ...............................................................................................1-53 119. Polymer Issues (not concerning exemptions) ................................................... 1-55 120. Principal Importer ........................................................................................... 1-59 121. Import Issues ................................................................................................... 1-59 122. Biotechnology ................................................................................................. 1-60 123. Significant New Use Rule (SNUR) ................................................................ 1-61 124. Pollution Prevention ....................................................................................... 1-64 125. Recycling ....................................................................................................... 1-64 126. New Chemical Exposure Limits (NCELs) ..................................................... 1-65 2. EXCLUSIONS 201. Impurities ........................................................................................................ 2-1 202. Mixtures .......................................................................................................... 2-2 203. Non-isolated Intermediates ............................................................................. 2-3 204. Byproducts ...................................................................................................... 2-5 205. End Use Reactions .......................................................................................... 2-7 206. Modifier of Physicochemical Characteristics ................................................. 2-7 207. Articles ............................................................................................................ 2-7 208. The Two Percent Rule for Polymers ............................................................... 2-11 ii 209. Chemicals Manufactured Solely for Export .................................................... 2-14 210. Uses Covered by FIFRA ................................................................................ 2-17 211. Pesticide Inerts ................................................................................................ 2-18 212. Pesticide Ingredients ....................................................................................... 2-19 213. Pesticide Intermediates ..................................................................................... 2-19 214. Uses Covered by FDA .................................................................................... 2-20 215. Naturally Occurring Substances ...................................................................... 2-22 216. Precipitation Inhibitors .................................................................................... 2-22 217. pH Adjustment ................................................................................................ 2-22 218. 40 CFR §720.30(h)(7) ...................................................................................... 2-23 219. New Chemical Formed Incidental to Storage .................................................. 2-24 3. EXEMPTIONS 301. Research and Development ............................................................................. 3-1 302. Test Marketing Exemption ............................................................................. 3-5 303. Low Volume Exemption ................................................................................. 3-7 304. Polymer Exemption ........................................................................................ 3-12 305. LoREX Exemption ......................................................................................... 3-13 4. COMPLIANCE AND ENFORCEMENT 401. Compliance Issues ........................................................................................... 4-1 402. Enforcement Issues ......................................................................................... 4-1 403. European Community ..................................................................................... 4-2 404. Canada ............................................................................................................. 4-4 iii HIGHLIGHTS OF THE NEW CHEMICALS PROGRAM Q&A Interested parties have asked many questions of the New Chemicals Program over the years. While responsive to the specific individuals asking the questions, EPA recognizes that it would be useful to a broader array of stakeholders to provide one, easily referenced document which compiles this guidance information. This Questions and Answers document (the Q&A) is derived from these compiled questions, rather than having been designed as an overall explanation of the program. • A general program description is provided at the New Chemicals Website, at www.epa.gov/oppt/newchems/, and in the New Chemicals Brochure, available from the TSCA Hotline at (202) 554-1404, or e-mail at [email protected]. • In addition, the Instruction Manual for submission of §5 notices (also available at the New Chemicals Website) discusses program policy and intent in the context of the PMN form. This Q&A document is available both in hard copy and electronically. Although the content is the same, we believe the electronic version will be easier to use, utilizing a search function, if a computer is available to you. The electronic version can be downloaded from the New Chemicals Website. The paper version is also available from the TSCA Hotline by mail. This Q&A document is intended only to explain the requirements of TSCA §5 and selected EPA regulations implementing §5, and to provide useful information to persons subject to these requirements. It is not a substitute for applicable legal requirements, nor is it a regulation itself. Thus, it does not impose legally-binding requirements on any party, including EPA or the regulated community. iv Section 1: General Program Information 1. GENERAL PROGRAM INFORMATION 100. General 100-1. Q. How can I obtain a copy of the printed §5 Pre-Manufacture Notice (PMN) form? A. The §5 PMN form (EPA Form 7710-25) is available from the TSCA Hotline upon request by voice (202-554-1404), facsimile (202-554-5603) or by e-mail ([email protected]). An instruction manual is also available from the Hotline to assist you in filling out the §5 submission form. There is a printable copy (.pdf) of the form at the New Chemicals Website (www.epa.gov/oppt/newchems/). The TSCA Hotline is a source of general program information. 100-2. Q. When does EPA expect to publish a format for electronic submissions so that I can submit my PMNs electronically? A. As of this writing, EPA has developed an early version of an electronic form. This current version and further instruction are available at the New Chemicals website (www.epa.gov/oppt/newchems). Submitters are invited to download this form and fill it out on their computers. At this time, we are only accepting paper copies made using this form. In the near future,