['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA', 'Toxic Substances - EPA']
03/13/2024
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[Editor’s Note: This section is revised effective September 6, 2022][Change Notice] [New Text]
(a) A person who intends to manufacture or process a chemical substance which is subject to a significant new use rule in subpart E of this part may ask EPA whether the substance or a proposed use is subject to the requirements of this part if that substance is described by a generic chemical name or if the significant new use is confidential and therefore not described specifically in the rule. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manufacture or process the chemical substance for commercial purposes.
(b) To establish a bona fide intent to manufacture or process a chemical substance, the person who proposes to manufacture or process the substance must submit the request to EPA via CDX. Prior to submission to EPA via CDX, such bona fide intents to manufacture or process must be generated and completed using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to access the e-PMN software. A bona fide intent to manufacture or process must contain:
(1) The specific chemical identity of the chemical substance that the person intends to manufacture or process.
(2) A signed statement that the person intends to manufacture or process the chemical substance for commercial purposes.
(3) A description of the research and development activities conducted to date, and the purpose for which the person will manufacture or process the chemical substance.
(4) An elemental analysis.
(5) Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (for most other substances), or an infrared spectrum of the particular chemical substance, or, if such data do not resolve uncertainties with respect to the identity of the chemical substance, additional or alternative spectra or other data to identify the substance.
(c) If an importer or processor cannot provide all the information required in paragraph (b) of this section because it is claimed as confidential business information by the importer's or processor's manufacturer or supplier, the manufacturer or supplier may supply the information directly to EPA.
(d) EPA will review the information submitted by the manufacturer or processor under paragraph (b) of this section to determine whether that person has shown a bona fide intent to manufacture or process the chemical substance. If necessary, EPA will compare this information to the information requested for the confidential chemical substance under §720.85(b)(3)(iii) of this chapter.
(e) If the manufacturer or processor has shown a bona fide intent to manufacture or process the substance and has provided sufficient unambiguous chemical identity information to enable EPA to make a conclusive determination as to the identity of the substance, EPA will inform the manufacturer or processor whether the chemical substance is subject to this part and, if so, which section in subpart E of this part applies, and identify any confidential significant new use designations.
(f) A disclosure to a person with a bona fide intent to manufacture or process a particular chemical substance that the substance is subject to this part or of confidential significant new use designations will not be considered public disclosure of confidential business information under section 14 of the Act.
(g) EPA will answer an inquiry on whether a particular chemical substance is subject to this part or identify and confidential significant new uses within 30 days after receipt of a complete submission under paragraph (b) of this section.
[71 FR 33641, June 12, 2006; 80 FR 42746, July 20, 2015; 87 FR 39764, July 5, 2022]
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['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA', 'Toxic Substances - EPA']
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Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.