Section 721.45 - ExemptionsThe persons identified in § 721.5 are not subject to the notification requirements of § 721.25 for a chemical substance identified in subpart E of this part, unless otherwise specified in a specific section in subpart E, if:
(a) The person has applied for and has been granted an exemption for test marketing the substance for a significant new use identified in subpart E of this part in accordance with section 5(h)(1) of the Act and § 720.38 of this chapter.(b) The person manufactures or processes the substance for a significant new use identified in subpart E of this part in small quantities solely for research and development in accordance with § 721.47 .(c) The person has applied for and been granted an exemption under section 5(h)(5) of the Act.(d) The person manufactures or processes the substance only as an impurity.(e) The person manufactures or processes the substance only as a byproduct which is used only by public or private organizations that (2) dispose of it as a waste, including in a landfill or for enriching soil, or(3) extract component chemical substances from it for commercial purposes.(f) The person imports or processes the substance as part of an article.(g) The person manufactures or processes the substance solely for export and, when distributing the substance in commerce, labels the substance in accordance with section 12(a)(1)(B) of the Act.(h) The person submits a significant new use notice for the substance prior to the promulgation date of the section in subpart E of this part which identifies the substance, and the person receives written notification of compliance from EPA prior to the effective date of such section. The notice submitter must comply with any applicable requirement of section 5(b) of the Act. The notice must include the information and test data specified in section 5(d)(1) of the Act and must be submitted on the notice form in appendix A to part 720 of this chapter. For purposes of this exemption, the specific section in subpart E of this part which identifies the substance and §§ 721.1 , 721.3 , 721.11 , 721.35 , and 721.40 apply; after the effective date of the section in subpart E of this part which identifies the substance, § 721.5 applies and § 721.20 continues to apply. EPA will provide the notice submitter with written notification of compliance only if one of the following occurs: (1) EPA is unable to make the finding that the activities described in the significant new use notice will or may present an unreasonable risk of injury to health or the environment under reasonably foreseeable circumstances.(2) EPA and the person negotiate a consent order under section 5(e) of the Act, such order to take effect on the effective date of the section in subpart E of this part which identifies the substance.(i) The person is operating under the terms of a consent order issued under section 5(e) of the Act applicable to that person. If a provision of such section 5(e) order is inconsistent with a specific significant new use identified in subpart E of this part, abiding by the provision of the section 5(e) order exempts the person from submitting a significant new use notice for that specific significant new use.53 FR 28361, July 27, 1988, as amended at 87 FR 39765 , July 5, 2022