(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); 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 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 266.501(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
266.501(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
pharmaceuticals" with "management of its subpart P hazardous waste".
(3) In
40
C.F.R. section 266.501(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 266.501(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
266.501(d)(1)(i), replace
"hazardous waste pharmaceuticals" with "subpart P hazardous waste".
(6) In
40
C.F.R. section 266.501(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
266.501(g)(1), insert "and
electronic nicotine delivery systems" after "Pharmaceuticals".
(8) In
40
C.F.R. section
266.501(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 266.501(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
266.501(g)(5), insert "and
electronic nicotine delivery systems" 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".
(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
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 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 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 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-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".
(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 "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:
(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)(H), 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".
