§716.3. Definitions. — Inbound Citations

(a) In general, health and safety studies, as defined in § 716.3, on any substance or listed mixture listed in § 716.120, that are unpublished are reportable, i.e., must be submitted or listed. However, this requirement has limitations according to the nature of the material studied, so that:

(1) However, in the case of physical and chemical properties, only those studies listed in § 716.50 must be submitted.

(2) Studies of mixtures known to contain substances or listed mixtures listed in § 716.120 are reportable except for studies of physical and chemical properties and the studies exempted at § 716.20(a)(6) (i) through (vi).

(3) Studies of substances or listed mixtures that a person who is reporting has manufactured, imported, or processed or proposed to manufacture, import, or process only as impurities are not generally reportable under § 716.20(a)(9).

(4) Underlying data, such as medical or health records, individual files, lab notebooks, and daily monitoring records supporting studies do not have to be submitted initially. EPA may request underlying data later under § 716.40.

The definitions in section 3 of TSCA and the definitions of §§ 704.3, 716.3, 717.3, and 790.3 of this chapter also apply to this part.

(2) Any manufacturer or importer of a chemical substance listed in § 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA no later than October 5, 1987 or 90 days after the person first manufactures or imports the chemical substance, whichever is later. The following provisions of part 716 of this chapter apply to submission of these studies: §§ 716.3, 716.10(a) (1) and (4); 716.20(a) (1), (2), (3), (4), (7), (8) and (10); 716.25; 716.30; 716.35(a) (1), (2), and (4) [if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; and 716.60(a)(2).