(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 (eliquid) 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 nonpharmaceutical 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 "nonsubpart
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 nonpharmaceutical hazardous waste" with
'subpart P hazardous waste and non-subpart P hazardous
waste".
(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)(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".