Section 721.80 - Industrial, commercial, and consumer activitiesWhenever a substance is identified in subpart E of this part as being subject to this section, a significant new use of the substance is:
(a) Use in non-enclosed processes.(b) Any manner or method of manufacture in non-enclosed processes associated with any use.(c) Any manner or method of processing in non-enclosed processes associated with any use.(d) Use beyond the site of manufacture.(e) Processing beyond the site of manufacture.(f) Any manner or method of manufacture (excluding import) of the substance associated with any use.(g) Use other than as an intermediate.(h) Use other than as a site-limited intermediate.(i) Use as an intermediate where the concentration of the intermediate substance in the product intended for distribution in commerce exceeds the concentration specified in subpart E of this part for the substance.(j) Use other than as described in the premanufacture notice referenced in subpart E of this part for the substance.(k) Use other than allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.(o) Use in a consumer product.(p) Aggregate manufacturing volume for any use greater than that specified in subpart E of this part for the substance.(q) Aggregate manufacturing volume for any use greater than that allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.(r) Aggregate manufacturing volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer has submitted the results of the health or environmental effects studies identified in subpart E of this part for the substance and those studies comply with the procedures and criteria for developing and evaluating data identified in subpart E of this part for the substance.(s) Annual manufacturing volume for any use greater than that specified in subpart E of this part for the substance.(t) Annual manufacturing volume for any use greater than that allowed by the section 5(e) consent order referenced in subpart E of this part for the substance.(u) Annual manufacturing volume for any use greater than that specified in subpart E of this part for the substance unless the manufacturer has submitted the results of the health or environmental effects studies identified in subpart E of this part for the substance and those studies comply with the procedures and criteria for developing and evaluating data identified in subpart E of this part for the substance.(w) Any manner or method of manufacture of the substance in the following form associated with any use: (x) Any manner or method of processing of the substance in the following form associated with any use: (y) Use involving an application method that generates:(1) A vapor, mist, or aerosol.54 FR 31308, July 27, 1989, as amended at 87 FR 39769, July 5, 2022 87 FR 39769, 9/6/2022; 87 FR 47103, 9/6/2022