HAR §11-266.1-17. (Reserved)

§11-266.1-18 Amendments to the incorporation of 40 C.F.R. part 266, subpart P. (a) The incorporation by reference of the heading of 40 C.F.R. part 266, subpart Pis amended as follows: insert "and Hazardous Waste Electronic Nicotine Delivery Systems" at the end of the heading. (b) The incorporation by reference of 40 C.F.R. section 266.500 is amended as follows: (1) The following definitions are excluded from incorporation: "Non-hazardous waste pharmaceutical" and "Non-pharmaceutical hazardous waste". (2) The following definitions are amended as follows: "Hazardous waste pharmaceutical" definition. Replace the definition in its entirety to read: ""Hazardous waste pharmaceutical" means a pharmaceutical that is a solid waste, as defined in 40 C.F.R. section 261.2, as incorporated and amended in section 11-261.1-1, and a hazardous waste, as defined in 40 C.F.R. section 261.3, as incorporated and amended in section 11-261.1-1." "Pharmaceutical" definition. Delete "; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); 266.1-8 §11-266.1-18 or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials)" and insert "Pharmaceutical includes an electronic nicotine delivery system that is subject to regulation as a drug, device, or combination product by the U.S. Food and Drug Administration." after "spills of pharmaceuticals.". (3) Add the following additional definitions in alphabetical order: "Electronic nicotine delivery system" means any electronic device that can be used to aerosolize and deliver nicotine to the person inhaling from the device (e.g., electronic cigarette, electronic pipe, vaping pen) and any liquid nicotine (e- liquid) packaged for retail sale for use in such a device (e.g., pre-filled cartridge, tank, pod, or vial). "Electronic nicotine delivery system retailer" means any person who distributes or sells electronic nicotine delivery systems. This definition includes, but is not limited to, retailers who sell products directly to consumers, wholesale distributors, and third-party logistics providers that serve as forward distributors. This definition does not include manufacturers or reverse logistics centers. "Hazardous waste electronic nicotine delivery system" means an electronic nicotine delivery system that is a solid waste, as defined in 40 C.F.R. section 261.2, as incorporated and amended in section 11-261.1-1, and a hazardous waste, as defined in 40 C.F.R. section 261.3, as incorporated and amended in section 11-261.1-1. "Household waste electronic nicotine 266.1-9 §11-266.1-18 delivery system" means an electronic nicotine delivery system that is a solid waste, as defined in 40 C.F.R. section 261.2, as incorporated and amended in section 11-261.1-1, but is excluded from being a hazardous waste under 40 C.F.R. section 261.4(b) (1), as incorporated and amended in section 11-261.1-1. "Non-creditable subpart P hazardous waste" means a non-creditable hazardous waste pharmaceutical or a hazardous waste electronic nicotine delivery system. "Non-subpart P hazardous waste" means a solid waste, as defined in 40 C.F.R. section 261.2, as incorporated and amended in section 11-261.1-1, that is a hazardous waste, as defined in 40 C.F.R. section 261.3, as incorporated and amended in section 11-261.1-1, and is not a pharmaceutical or electronic nicotine delivery system, as defined in this section. "Subpart P hazardous waste" means a hazardous waste pharmaceutical or a hazardous waste electronic nicotine delivery system. (c) The incorporation by reference of 40 C.F.R. section 266.501 is amended as follows: (1) In 40 C.F.R. section 266.S0l(a), insert "or electronic nicotine delivery system retailer" after "healthcare facility" and replace "its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste" with "its subpart P hazardous waste and its non-subpart P hazardous waste". (2) In 40 C.F.R. section 266.S0l(b), insert "or electronic nicotine delivery system retailer" after "healthcare facility", replace "its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste" with "its subpart P hazardous waste and its non-subpart P hazardous waste", and replace "management of its hazardous waste 266.1-10 §11-266.1-18 pharmaceuticals" with "management of its subpart P hazardous waste". (3) In 40 C.F.R. section 266.50l(c), insert ", electronic nicotine delivery system retailer," after "healthcare facility" and replace "non-pharmaceutical hazardous waste" with "non-subpart P hazardous waste". (4) In 40 C.F.R. section 266.50l(d), insert "and electronic nicotine delivery system retailers" after "healthcare facilities" and insert "or electronic nicotine delivery system retailer" after "healthcare facility". (5) In 40 C.F.R. section 266.50l(d) (1) (i), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (6) In 40 C.F.R. section 266.50l(f), insert "and electronic nicotine delivery systems" after "Hazardous waste pharmaceuticals", insert ", electronic nicotine delivery system retailers," after "healthcare facilities", insert", electronic nicotine delivery system manufacturers," after "pharmaceutical manufacturers", and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (7) In 40 C.F.R. section 266.50l(g) (1), insert "and electronic nicotine delivery systems" after "Pharmaceuticals". (8) In 40 C.F.R. section 266.50l(g) (2), replace "Over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs" with "Nonprescription pharmaceuticals and electronic nicotine delivery systems". (9) In 40 C.F.R. section 266.50l(g) (3) and (4), insert "and electronic nicotine delivery systems" after "Pharmaceuticals" and insert "and hazardous waste electronic nicotine delivery systems" after "hazardous waste pharmaceuticals". (10) In 40 C.F.R. section 266.50l(g) (5), insert "and electronic nicotine delivery systems" 266.1-11 §11-266.1-18 after "Pharmaceuticals" and "pharmaceuticals". (11) In 40 C.F.R. section 266.501(g) (7), insert "and household waste electronic nicotine delivery systems" after "Household waste pharmaceuticals". (d) The incorporation by reference of 40 C.F.R. section 266.502 is amended as follows: (1) In the heading of 40 C.F.R. section 266.502, insert "and electronic nicotine delivery system retailers" after "healthcare facilities" and replace "non-creditable hazardous waste pharmaceuticals" with "non- creditable subpart P hazardous waste (non- creditable hazardous waste pharmaceuticals and hazardous waste electronic nicotine delivery systems)". (2) In 40 C.F.R. section 266.502(a), replace"" with "and electronic nicotine delivery system retailers managing hazardous waste electronic nicotine delivery systems.". (3) In 40 C.F.R. section 266.502(a) (1), insert "or electronic nicotine delivery system retailer" after the first, second, and fourth instances of "healthcare facility". (4) In 40 C.F.R. section 266.502(a) (1) (i) and (ii), insert "or electronic nicotine delivery system retailer" after the first instance of "healthcare facility" and replace "as part of its next Biennial Report, if it is required to submit one; or if not required to submit a Biennial Report," with "or electronic nicotine delivery system retailer". (5) In 40 C.F.R. section 266.502 (a) (1) (iii), insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility". (6) In 40 C.F.R. section 266.502(a) (2), insert "or electronic nicotine delivery system retailer" after the first and third instances of "healthcare facility". 266.1-12 §11-266.1-18 (7) In 40 C.F.R. section 266.502(a) (2) (i) and (ii), insert "or electronic nicotine delivery system retailer" after "healthcare facility". (8) In 40 C.F.R. section 266.502(b), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste", insert "and electronic nicotine delivery system retailers" after "healthcare facilities", and insert "or electronic nicotine delivery system retailer" after "healthcare facility". (9) In 40 C.F.R. section 266.502(c), insert "and electronic nicotine delivery systems" after "non-creditable pharmaceuticals", insert "or electronic nicotine delivery system retailer" after the first instance of "healthcare facility", insert "or electronic nicotine delivery system" after "non- creditable pharmaceutical", and replace "that pharmaceutical is a hazardous waste pharmaceutical" with "that pharmaceutical or electronic nicotine delivery system is a hazardous waste". (10) In 40 C.F.R. section 266.502(d), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste" and insert "and electronic nicotine delivery system retailers" after "healthcare facilities". (11) In 40 C.F.R. section 266.502(d) (1) and (2), insert "or electronic nicotine delivery system retailer" after "healthcare facility" and replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (12) In 40 C.F.R. section 266.502(d) (2) (iv), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (13) In 40 C.F.R. section 266.502(d) (3), insert "or electronic nicotine delivery system retailer" after "healthcare facility" and 266.1 13 §11-266.1-18 replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (14) In 40 C.F.R. section 266.502(e), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste", insert "and electronic nicotine delivery system retailers" after "healthcare facilities", and insert "An electronic nicotine delivery system retailer must label or clearly mark each container of hazardous waste electronic nicotine delivery systems with the phrase "Hazardous Waste Electronic Nicotine Delivery Systems."" at the end of the paragraph. (15) In 40 C.F.R. section 266.502(f), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste" and insert "and electronic nicotine delivery system retailers" after "healthcare facilities". (16) In 40 C.F.R. section 266.502(f) (1), insert "or electronic nicotine delivery system retailer" after "healthcare facility" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (17) In 40 C.F.R. section 266.502(f) (2), insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility", replace the first instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste", and replace "hazardous waste pharmaceuticals have" with "subpart P hazardous waste has". (18) In 40 C.F.R. section 266.502(f) (2) (i) to (iii), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (19) In 40 C.F.R. section 266.502(g), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste", replace "are" with "or electronic nicotine delivery system retailer is", insert "or electronic nicotine delivery 266.1-14 §11-266.1-18 system retailer" after the second instance of "healthcare facility", replace "it" with "a healthcare facility", and insert "for non-creditable hazardous waste pharmaceuticals" at the end of the section. (20) In 40 C.F.R. section 266.502(h), insert "and electronic nicotine delivery system retailers" after "healthcare facilities", replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste", and insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility". (21) In 40 C.F.R. section 266.502(h) (3), insert "or electronic nicotine delivery system retailer" after "healthcare facility". (22) In 40 C.F.R. section 266.502(i), insert "and electronic nicotine delivery system retailers" after "healthcare facilities" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (23) In 40 C. F. R. section 266. 502 (i) (1), insert "and electronic nicotine delivery system retailers" after "healthcare facilities" and "Healthcare facilities" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (24) In 40 C.F.R. section 266.502(i) (2), insert "and electronic nicotine delivery system retailers" after "healthcare facilities". (25) In 40 C.F.R. section 266.502(i) (2) (i), insert "or electronic nicotine delivery system retailer" after "healthcare facility". (26) In 40 C.F.R. section 266.502(i) (2) (i) (A), insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (27) In 40 C.F.R. section 266.502(i) (2) (i) (A) (1), insert "or electronic nicotine delivery 266.1-15 §11-266.1-18 system retailer" after "healthcare facility". (28) In 40 C. F.R. section 266. 502 (i) (2) (i) (A) (2), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (29) In 40 C.F.R. section 266.502(i) (2) (ii) (A), insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility" and replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (30) In 40 C.F.R. section 266. 502 (i) (2) (ii) (A) (1), insert "or electronic nicotine delivery system retailer" after "healthcare facility". (31) In 40 C.F.R. section 266. 502 (i) (2) (ii) (A) (2), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (32) In 40 C.F.R. section 266.502(i) (3), insert "and electronic nicotine delivery system retailers" after "healthcare facilities" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (33) In 40 C.F.R. section 266.502(j), insert "and electronic nicotine delivery system retailers" after "healthcare facilities" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (34) In 40 C.F.R. section 266.502(j) (1), insert "or electronic nicotine delivery system retailer" after "healthcare facility" and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (35) In 40 C.F.R. section 266.502(j) (2), insert "or electronic nicotine delivery system retailer" after "healthcare facility". (36) In 40 C.F.R. section 266.502(j)(3), insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility", insert "and waste electronic 266.1-16 §11-266.1-18 nicotine delivery systems" after "non- hazardous waste pharmaceuticals", and replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (37) In 40 C.F.R. section 266.502(k), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste", insert "and electronic nicotine delivery system retailers" after "healthcare facilities", and insert "or electronic nicotine delivery system retailer" after "healthcare facility". (38) In 40 C.F.R. section 266.502(1), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste" and insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility". (39) In 40 C.F.R. section 266.502(1) (1), insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility", replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste", insert "and electronic nicotine delivery system retailers" after each instance of "healthcare facilities", and insert "or electronic nicotine delivery systems" after "supplies pharmaceuticals". (40) In 40 C.F.R. section 266.502(1) (2) to (4), replace "hazardous waste pharmaceuticals" with "subpart P hazardous waste". (e) The incorporation by reference of 40 C.F.R. section 266.504 is amended as follows: (1) In the heading of 40 C.F.R. section 266.504, insert "and electronic nicotine delivery system retailers" after "Healthcare facilities" and replace "hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste" with "subpart P hazardous waste and non-subpart P hazardous waste". (2) In 40 C.F.R. section 266.504(a), replace "hazardous waste pharmaceuticals and non- 266.1-17 §11-266.1-18 pharmaceutical hazardous waste" with "subpart P hazardous waste and non-subpart P hazardous waste". (3) In 40 C.F.R. section 266.504(b), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste", insert "or electronic nicotine delivery system retailer" after each instance of "healthcare facility", and replace "non-pharmaceutical" with "non- subpart P". (4) In 40 C.F.R. section 266.504(b) (1) and (2), insert "or electronic nicotine delivery system retailer" after "healthcare facility". (5) In 40 C.F.R. section 266.504(c), replace each instance of "hazardous waste pharmaceuticals" with "subpart P hazardous waste" and replace "non-pharmaceutical" with "non-subpart P". (6) In 40 C.F.R. section 266.504(d), replace "hazardous waste pharmaceuticals and non- pharmaceutical hazardous waste" with "subpart P hazardous waste and non-subpart P hazardous waste". (f) The incorporation by reference of 40 C.F.R. section 266.505 is amended as follows: (1) In the heading of 40 C.F.R. section 266.505, insert "and hazardous waste electronic nicotine delivery systems" after "pharmaceuticals". (2) In 40 C.F.R. section 266.505, insert "and electronic nicotine delivery system retailers" after "healthcare facilities", insert "and hazardous waste electronic nicotine delivery systems" after "pharmaceuticals", and insert", electronic nicotine delivery system retailers," after "Healthcare facilities". (g) The incorporation by reference of 40 C.F.R. section 266.506 is amended as follows: 266.1-18 §11-266.1-18 (1) In the heading of 40 C.F.R. section 266.506, insert "and household waste electronic nicotine delivery systems" after "household waste pharmaceuticals". (2) In 40 C.F.R. section 266.506(a) (2), insert "and household waste electronic nicotine delivery systems" after "Household waste pharmaceuticals" and "household waste pharmaceuticals". (3) In 40 C.F.R. section 266.506(b), insert "and hazardous waste electronic nicotine delivery systems" after "hazardous waste pharmaceuticals". (h) The incorporation by reference of 40 C.F.R. section 266.507 is amended as follows: (1) In the heading of 40 C.F.R. section 266.507, insert "or hazardous waste electronic nicotine delivery systems" after "hazardous waste pharmaceuticals". (2) In 40 C.F.R. section 266.507(a), insert "Nicotine e-liquid vials packaged for retail sale in electronic nicotine delivery systems (not to exceed 1 liter) are considered empty and the residues are not regulated as hazardous waste provided the liquid has been removed by pouring out the contents." at the end of the paragraph. (3) In 40 C.F.R. section 266.507(d), insert "At electronic nicotine delivery system retailers operating under 40 C.F.R. part 266, subpart P, as incorporated and amended in this chapter, electronic nicotine delivery systems (including attached or attachable cartridges, pods, or tanks) that are unused, partially used, or fully used must be managed as non-creditable subpart P hazardous waste, except empty vials described in paragraph (a)." at the end of the paragraph. (i) The incorporation by reference of 40 C.F.R. section 266.508 is amended as follows: 266.1-19 §11-266.1-18 (1) In the heading of 40 C.F.R. section 266.508, replace "non-creditable hazardous waste pharmaceuticals" with "non-creditable subpart P hazardous waste (non-creditable hazardous waste pharmaceuticals and hazardous waste electronic nicotine delivery systems)" and insert "or electronic nicotine delivery system retailer" after "healthcare facility". (2) In 40 C.F.R. section 266.508(a), replace each instance of "non-creditable hazardous waste pharmaceuticals" with "non-creditable subpart P hazardous waste" and insert "or electronic nicotine delivery system retailer" after "healthcare facility". (3) In 40 C.F.R. section 266.508 (a) (1) (iii) (A), insert "or electronic nicotine delivery systems" after "pharmaceuticals". (4) In 40 C.F.R. section 266.508(a) (1) (iii) (B), replace each instance of "Facility's" with "facility's, Electronic nicotine delivery system retailer's,". (5) In 40 C.F.R. section 266.508(a) (2) (ii), replace "the word "PHARMS"" with "either the code "PHARMS" or the code "PHRM"". (6) In 40 C.F.R. section 266.508(b) and (c), replace each instance of "non-creditable hazardous waste pharmaceuticals" with "non- creditable subpart P hazardous waste" and insert", electronic nicotine delivery system retailer," after "healthcare facility". [Eff and comp 6/25/20; am and comp 6/7/21; am and comp 1/29/24; am and comp JUL -7 202~ ] (Auth: HRS §§342J-4, 342J-31, 342J-32, 342J-33, 342J-34, 342J-34.5, 342J-35) (Imp: HRS §§342J-4, 342J-31, 342J-32, 342J-33, 342J-34, 342J-34.5, 342J-35) 266.1-20 §11-268.1 1