Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of Solid Waste Rule; Technical Corrections, 99727-99732 [2024-28802]
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Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Rules and Regulations
99727
REFRIGERATION AND AIR CONDITIONING—Continued
End-use
Substitute
Decision
Further information 1
Retail food refrigeration—Remote condensing units (retrofit equipment only).
R–471A ................
Acceptable ............
Retail food refrigeration—Supermarket systems (retrofit
equipment only).
R–471A ................
Acceptable ............
Water coolers (retrofit equipment only).
R–480A ................
Acceptable ............
This substitute is a blend of 78.7 percent HFO–1234ze(E), which is also known as trans1,3,3,3-tetrafluoroprop-1-ene; (CAS Reg. No. 29118–24–9); 17.0 percent HFO–
1336mzz(E), also known as trans-1,1,1,4,4,4-hexafluoro-2-butene (CAS Reg. No.
66711–86–2); and 4.3 percent HFC–227ea, which is also known as 1,1,1,2,3,3,3heptafluoropropane (CAS Reg. No. 431–89–0).
R–471A has a GWP of 144 and an ODP of 0. The blend is not flammable as it has an
ASHRAE flammability classification of ‘‘1’’. ASHRAE has established an OEL for the
blend of 710 ppm (8-hr TWA). For the components of R–471A, OARS has established a
WEEL of 400 ppm on an 8-hr TWA for HFO–1336mzz(E), AIHA has established a
WEEL of 1,000 ppm for HFC–227ea (8-hr TWA), and ASHRAE has adopted an OEL of
800 ppm on an 8-hr TWA for HFO–1234ze(E).
This substitute is a blend of 78.7 percent HFO–1234ze(E), which is also known as trans1,3,3,3-tetrafluoroprop-1-ene; (CAS Reg. No. 29118–24–9); 17.0 percent HFO–
1336mzz(E), also known as trans-1,1,1,4,4,4-hexafluoro-2-butene (CAS Reg. No.
66711–86–2); and 4.3 percent HFC–227ea, which is also known as 1,1,1,2,3,3,3heptafluoropropane (CAS Reg. No. 431–89–0).
R–471A has a GWP of 144 and an ODP of 0. The blend is not flammable as it has an
ASHRAE flammability classification of ‘‘1’’. ASHRAE has established an OEL for the
blend of 710 ppm (8-hr TWA). For the components of R–471A, OARS has established a
WEEL of 400 ppm on an 8-hr TWA for HFO–1336mzz(E), AIHA has established a
WEEL of 1,000 ppm for HFC–227ea (8-hr TWA), and ASHRAE has adopted an OEL of
800 ppm on an 8-hr TWA for HFO–1234ze(E).
This substitute is a weighted blend of 5 percent CO2, 86 percent HFO–1234ze(E), which is
also known as trans-1,3,3,3-tetrafluoroprop-1-ene CAS Reg. No. 29118–24–9), and 9
percent HFC–227ea, which is also known as 1,1,1,2,3,3,3-heptafluoropropane (CAS
Reg. No. 431–89–0).
R–480A has a GWP of 291 and an ODP of 0. The blend is not flammable as it has an
ASHRAE flammability classification of ‘‘1.’’ ASHRAE has adopted an OEL for the blend
of 900 ppm (8-hr TWA). For the components of R–480A, OSHA has established a PEL
for CO2 of 5,000 ppm on an 8-hr TWA, AIHA has established a WEEL of 1,000 ppm for
HFC–227ea (8-hr TWA), and ASHRAE has adopted an OEL of 800 ppm on an 8-hr
TWA for HFO–1234ze(E).
1 See
recommendations in the manufacturer’s SDS and guidance for all listed refrigerants.
FOAM BLOWING
End-use
Polystyrene: Extruded
boardstock and billet.
1 See
Decision
Further information 1
Acceptable ............
HFO–1234ze(E) is also known as trans-1,3,3,3-tetrafluoroprop-1-ene
(Chemical Abstracts Service Registry Number [CAS Reg. No.] 29118–
24–9). HFO–1336mzz(Z) is also known as (Z)-1,1,1,4,4,4-hexafluoro2-butene and cis-1,1,1,4,4,4-hexafluoro-2-butene (CAS Reg. No. 692–
49–9). HFC–152a is also known as 1,1-difluoroethane (CAS Reg. No.
75–37–6). CO2 has CAS Reg. No. 124–38–9.
These blends have 100-year GWPs from 1 to about 94, depending on
the specific composition. Blends of these compounds anticipated to
be used in manufacturing are flammable.
The AIHA has established a WEEL of 1,000 ppm for HFC–152a on an
eight-hour Time-Weighted Average (8-hr TWA). The OARS has established a WEEL of 500 ppm (8-hr TWA) for HFO–1336mzz(Z). The
manufacturer of HFO–1234ze(E) has established an OEL of 800 ppm
(8-hr TWA) and the American Society of Heating, Refrigerating and
Air-Conditioning Engineers has adopted an OEL of 800 ppm (8-hr
TWA) for this compound. The U.S. OSHA has established a PEL of
5,000 ppm on an 8-hr TWA for CO2.
Substitute
Extruded polystyrene (XPS) foam blowing
agent blends of 0 to 90 percent HFO–
1336mzz(Z), 0 to 90 percent HFO–
1234ze(E), 0 to 75 percent HFC–152a,
and 0 to 90 percent CO2.
recommendations in the manufacturer’s SDS and guidance for all listed foam blowing agents.
[FR Doc. 2024–28307 Filed 12–10–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 261, 262, and 266
[EPA–HQ–OLEM–2023–0081; FRL 8687–04–
OLEM]
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RIN 2050–AH23
Hazardous Waste Generator
Improvements Rule, the Hazardous
Waste Pharmaceuticals Rule, and the
Definition of Solid Waste Rule;
Technical Corrections
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
Final rule.
The Environmental Protection
Agency (EPA or the Agency) is
finalizing five amendments that were
withdrawn in its December 6, 2023,
partial withdrawal of direct final rule.
Due to receipt of adverse comments, the
EPA withdrew eight amendments from
the August 9, 2023, direct final rule that
included revisions to the 2016
Hazardous Waste Generator
Improvements Rule, the 2019 Hazardous
Waste Pharmaceuticals Rule and the
2018 Vacatur of the Definition of Solid
Waste Rule (88 FR 54086). The EPA is
SUMMARY:
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Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Rules and Regulations
B. What action is the agency taking?
responding to the relevant adverse
comments in this action.
This final rule is effective on
February 10, 2025.
DATES:
The EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OLEM–2023–0081. All
documents in the docket are listed on
the https://www.regulations.gov website.
Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kathy Lett, U.S. Environmental
Protection Agency, Office of Resource
Conservation and Recovery (MC:
5304T), 1200 Pennsylvania Avenue NW,
Washington, DC 20460, (202) 566–0517,
(lett.kathy@epa.gov) or Kristin
Fitzgerald, U.S. Environmental
Protection Agency, Office of Resource
Conservation and Recovery (MC:
5304T), 1200 Pennsylvania Avenue NW,
Washington, DC 20460, (202) 566–0512
(fitzgerald.kristin@epa.gov).
SUPPLEMENTARY INFORMATION:
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I. General Information
This action finalizes five amendments
that were included in its August 9,
2023, direct final rule that made
technical corrections to three
rulemakings related to the generation of
hazardous waste: the 2016 Hazardous
Waste Generator Improvements Rule,
the 2019 Hazardous Waste
Pharmaceuticals Rule, and the 2018
Vacatur of the Definition of Solid Waste
Rule (88 FR 54086). Due to receipt of
adverse comments, eight amendments
were withdrawn in the EPA’s December
6, 2023, partial withdrawal of direct
final rule (88 FR 84710). EPA has
evaluated the comments received on the
amendments and is finalizing five of
these amendments, found in
§§ 261.4(e)(1), 262.16(b)(1),
262.17(a)(8)(i) introductory text,
262.17(a)(8)(i)(A) and 266.508(a)(2)(ii).
These five provisions relate to the 2016
Hazardous Waste Generator
Improvements Rule and the 2019
Hazardous Waste Pharmaceuticals Rule.
Finalizing these technical corrections
will correct or clarify the regulations for
generators and handlers of hazardous
waste. The EPA is also responding in
this preamble to the adverse comments
on the items that we are finalizing in
this action. The three provisions we are
not finalizing will not go into effect with
this action and the EPA is not
responding to the adverse comments on
these three provisions.
A. Does this action apply to me?
C. What is the agency’s authority for
taking this action?
Entities potentially affected by this
action include hazardous waste
generators, treatment, storage, and
disposal facilities, healthcare facilities,
reverse distributors, importers/exporters
of hazardous waste, and users of the
transfer-based exclusion to the
definition of solid waste. Also affected
are States and EPA Regions
implementing these RCRA hazardous
waste regulations.
This discussion is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by this action. This discussion
includes the types of entities that the
EPA is now aware could potentially be
regulated by this action. Other types of
entities not included could also be
regulated. To determine whether your
entity is regulated by this action, you
should carefully examine the
applicability criteria found in Section IV
of the preamble. If you have questions
regarding the applicability of this action
to a particular entity, consult the
persons listed in the FOR FURTHER
INFORMATION CONTACT section.
This rule is authorized under sections
1004, 2002, 3001, 3002, 3003, 3004,
3005, 3006, and 3010, of the Resource
Conservation and Recovery Act of 1976,
as amended, 42 U.S.C. 6903, 6912, 6921,
6922, 6923, 6924, 6925, 6926, and 6930.
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III. Background
In the EPA’s August 9, 2023, direct
final rule (88 FR 54086), EPA explained
that the Agency views the minor fixes
and clarifications included in the action
as noncontroversial. However, EPA
published a parallel proposed rule the
same day that could serve as the
proposed rule to adopt the provisions in
the direct final rule if adverse comments
were received. EPA stated that in this
case, there would not be a second
comment period on this action.
The direct final rule preamble also
stated that if the Agency were to receive
adverse comment on any individual
correction, we would publish a timely
withdrawal in the Federal Register
informing the public about the specific
regulatory paragraph or amendment that
will not take effect.
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The EPA received adverse comments
on eight amendments from the direct
final rule and withdrew them on
December 6, 2023 (88 FR 84710). All
corrections that were not withdrawn
became effective on December 7, 2023.
IV. Provisions Being Finalized and
Response to Comment
A. Section 261.4(e)(1)
The August 9, 2023, direct final rule
identified a number of regulatory
citations that were incorrect and
outdated in the regulations for
generators of hazardous waste and
updated those citations. Section 261.4(e)
provides requirements for management
of samples used in treatability studies
and included citations that needed to be
updated. The list of corrections
included revising § 261.4(e)(1) to
replace the references to quantity
determinations in §§ 261.5 and
262.34(d) with a reference to the
counting requirements in § 262.13 and
the accumulation limits in
§ 262.16(b)(1).
EPA received an adverse comment to
this revision. The commenter stated that
it appears that the revised citation in
this location, which identifies which
categories of generators do not need to
count treatability sample weight
towards generator accumulation limits
was incomplete. The comment stated
that the revised citation should point to
the accumulation limits for very small
quantity generators (VSQGs), large
quantity generators (LQGs), and satellite
accumulation areas (SAAs), not just
SQGs.
EPA partially agrees with the
commenter and is revising this citation
to include references to §§ 262.14(a)(3)
and (4), the accumulation limits for
VSQGs accumulating acute and nonacute hazardous waste. The original
language in this section referred to
accumulation limits for VSQGs and
SQGs and this revision reestablishes
those two references. Generators
accumulating waste at SAAs must
include that waste in their monthly
quantities for determining generator
status, but the original regulatory
language did not refer to the SAA
requirements and LQGs do not have an
accumulation limit. For these reasons,
EPA is not amending the language to
add any references to SAA or LQG
requirements.
B. Section 262.16(b)(1)
The 2016 Generator Improvements
rule established definitions for very
small, small, and large quantity
generators, reorganized the regulations
for these categories of generators, and
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clearly distinguished the generator
categories—determined by how much
hazardous waste is generated per
calendar month at a site—from the
conditions for exemption that specify
limits for how much hazardous waste
small and very small quantity generators
can accumulate on site at any one time.
However, the small quantity generator
conditions for exemption include an onsite accumulation limit of 6,000
kilograms for non-acute hazardous
waste but do not specify an on-site
accumulation limit for acute hazardous
waste.
In the original 1980 hazardous waste
generator regulations, there were only
two categories of hazardous waste
generator: small (generating less than
1,000 kilograms of hazardous waste per
month) and large (generating more than
1,000 kilograms of hazardous waste per
month). These pre-1986 small quantity
generators had a total on-site hazardous
waste accumulation limit of 6,000
kilograms of non-acute hazardous waste
and one kilogram of acute hazardous
waste. The 1986 rule that established
the category and specific requirements
for those generating between 100
kilograms and 1,000 kilograms per
month (small quantity generators) (51
FR 10146; March 24, 1986)
implemented the changes to the
hazardous waste program required by
the Hazardous and Solid Waste
Amendments of 1984 (HSWA) and
established a new category of
‘‘conditionally exempt small quantity
generator’’ for those generating less than
100 kilograms of non-acute hazardous
waste per month.
The scope of HSWA and the new
regulations for conditionally exempt
small quantity generators did not
include acute hazardous waste.
Therefore, generators generating less
than one kilogram of acute hazardous
waste per month are conditionally
exempt small quantity generators and
those generating more than one
kilogram of acute hazardous waste per
month are large quantity generators.
There is no separate small quantity
generator category based solely on
generation of acute hazardous waste.
The EPA clarified the distinctions
between the three generator categories
in the 2016 Generator Improvements
rule and stated that a small quantity
generator can only generate up to one
kilogram of acute hazardous waste in a
calendar month, but it was not clear in
the new language whether there is a
limit on the amount of acute hazardous
waste a small quantity generator can
accumulate on site at any one time.
Consistent with what has been
historically allowed for generators of
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small amounts of acute hazardous waste
since the 1980 regulations, in the
August 2023 technical correction notice,
the EPA revised § 262.16(b)(1) to clarify
that the acute hazardous waste
accumulation limit for a small quantity
generator is one kilogram.
The EPA received an adverse
comment on this provision. One
commenter stated that a 1-kilogram
limit for small quantity generators
accumulating acute hazardous waste
would create severe logistical issues for
facilities that generate just slightly
under 1 kilogram per month of acutely
hazardous waste as the proposed rule
will essentially make their allowable
accumulation time 30 days. The
commenter stated that it would be
‘‘impossible to collect samples,
characterize the waste, receive disposal
approval for the waste and have the
waste transported offsite within the
allowable time frame.’’
EPA disagrees with the comment. As
described in this preamble, a 1-kilogram
accumulation limit for this category of
generator was part of the RCRA
regulations starting in 1980 and the
revision being made is to make that
clearer in the regulations. The generator
regulations are designed so that if a
generator needs additional time to
sample, characterize, and arrange for
disposal of an acute hazardous waste
that is accumulating on site, it can
operate under the requirements for a
large quantity generator instead of those
of a small quantity generator and remain
in compliance with the generator
regulations. The additional large
quantity generator standards ensure the
safe handling of the elevated amounts of
acute hazardous waste being
accumulated at the generator site.
EPA is finalizing this provision as
described in the August 9, 2023, notice.
C. Section 262.17(a)(8)(i) Introductory
Text and (a)(8)(i)(A)
The 2016 Hazardous Waste Generator
Improvements Rule added a
requirement that LQGs undergoing
closure of a hazardous waste unit
submit a notification that they are
closing that unit, including information
on the timing of the closure. The
generators have two options for
submitting that notification when a
specific waste accumulation unit is
closing, but the generator as a whole is
not closing all its units on site (i.e., it
will continue generating and
accumulating hazardous waste on site).
The 2023 direct final rule revised the
language in § 262.17(a)(8)(i) and
(a)(8)(i)(A) to more clearly describe
when the provisions apply and used the
defined term ‘‘final closure.’’ The
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preamble to the 2023 direct final rule
explained that EPA made these changes
to distinguish between the requirements
that apply when a unit is closing and
those that apply when the whole facility
is closing.
EPA received an adverse comment on
this revision from a State that
implements hazardous waste
regulations. The commenter argued that
a reference to the defined term ‘‘final
closure’’ in this introductory text is not
appropriate and suggested that EPA
instead use the phrase ‘‘undergoing
closure of the facility.’’ The commenter
argues that this would be more
appropriate for a generator closing a
waste unit and needing to follow this
requirement.
The commenter also submitted
comments on a suggested revision to
§ 262.17(a)(8)(i)(A), stating that this part
of the closure regulations would be
clearer if the last statement in
§ 262.17(a)(8)(i)(B) about when a
generator can remove a closure notice
from its operating record because a
waste accumulation unit was reopened
was moved from § 262.17(a)(8)(i)(B) to
§ 262.17(a)(8)(i)(A).
EPA agrees that using the term ‘‘final
closure’’ in this paragraph adds
unnecessary confusion and that the
sentence the commenter identified
would make more sense in the revised
§ 262.17(a)(8)(i)(A). EPA is finalizing
revisions to this section to make those
changes and to state that the regulations
apply when closing a waste
accumulation unit but not all waste
accumulation units.
D. Section 266.508(a)(2)(ii)
The preamble to the 2023 direct final
rule explained that EPA was amending
§ 266.508(a)(2)(ii) in two ways. First,
EPA allowed the four-character PHRM
code as well as the existing six-character
PHARMS code in Item 13 when
manifesting non-creditable hazardous
waste pharmaceuticals to a TSDF. This
was consistent with guidance EPA
issued in 2019.1 Second, EPA inserted
a sentence at the end clarifying that a
healthcare facility may choose to
include the applicable EPA hazardous
waste numbers (i.e., hazardous waste
codes) in Item 13 of EPA Form 8700–22,
in addition to the PHARMS or PHRM
code that was already required. This
was consistent with preamble from the
Hazardous Waste Pharmaceuticals final
rule.2
EPA received one adverse comment
on the second provision. The
1 From Johnson to EPA Regions, December 19,
2019, RCRA Online #14919.
2 84 FR 5877; February 22, 2019.
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commenter was a State that expressed
concerns that the rule does not resolve
the issue that the inclusion of RCRA
codes with PHRM/PHARMS on a
manifest seems to negate any benefits
for a healthcare facility operating under
Subpart P. The State was concerned that
a healthcare facility would be charged a
higher fee by those States which collect
fees. The State noted that including
PHRM or PHARMS along with RCRA
hazardous waste codes creates
confusion and that it is unclear why the
RCRA codes are being listed.
EPA disagrees with the commenter
and is finalizing the provision as
proposed. First, with respect to the
PHRM code, while we did not receive
any comments on this specific aspect of
the proposed amendment, the adverse
comment on other portions of the same
paragraph meant that this was
withdrawn, as well. This final rule
allows healthcare facilities to use the
PHRM or PHARMS code in Item 13
when manifesting non-creditable
hazardous waste pharmaceuticals.
Second, with respect to hazardous
waste codes, this final rule allows
healthcare facilities to include
hazardous waste codes in addition to
the PHRM/PHARMS code when
manifesting non-creditable hazardous
waste pharmaceuticals. As discussed in
a Frequent Question that is posted to
our website,3 as well as in a
memorandum,4 there are certain
situations where the hazardous waste
codes need to be included when
manifesting non-creditable hazardous
waste pharmaceuticals. For example, in
States that have not yet adopted part
266 subpart P, healthcare facilities are
subject to the standard 40 CFR part 262
generator regulations for their hazardous
waste pharmaceuticals, which require
healthcare facilities to include all
applicable waste codes on the manifest.
Therefore, if a healthcare facility that is
operating under part 266 subpart P
ships non-creditable hazardous waste
pharmaceuticals to a TSDF that is in a
State that has not yet adopted part 266
subpart P, the healthcare facility would
need to include the hazardous waste
codes to satisfy the regulatory
requirements in the receiving State.
Additionally, some vendors may require
their healthcare facility customers to
include the hazardous waste codes and
EPA does not want to preclude that
practice because including all
applicable hazardous waste codes could
3 https://www.epa.gov/hwgenerators/frequentquestions-about-management-standards-hazardouswaste-pharmaceuticals-and#e2.
4 From Johnson to EPA Regions, December 19,
2019, RCRA Online #14919.
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help receiving facilities better
understand the wastes and determine
the best course of management
including, for example, complying with
the land disposal restriction treatment
standards.
Finally, waste industry
representatives have told EPA that their
practice is to not commingle hazardous
waste pharmaceuticals in the same
container with non-pharmaceutical
hazardous wastes.5 This means that
when hazardous waste codes are
included on the same line of the
manifest as the PHRM/PHARMS code,
the hazardous waste codes can be
presumed to be referring to hazardous
waste pharmaceuticals, and not to other,
non-pharmaceutical hazardous wastes.
For these reasons, EPA is finalizing
regulatory language that allows a
healthcare facility to include the
hazardous waste codes in Item 13 of the
manifest, in addition to the PHRM/
PHARMS code.
V. State Authorization
A. Applicability of Rules in Authorized
States
Under section 3006 of RCRA, the EPA
may authorize a qualified State to
administer its own hazardous waste
program within the State in lieu of the
Federal program. Following
authorization, the EPA retains
enforcement authority under sections
3008, 3013, and 7003 of RCRA, although
authorized States have primary
enforcement responsibility. The
standards and requirements for State
authorization are found at 40 CFR part
271.
Prior to enactment of the Hazardous
and Solid Waste Amendments of 1984
(HSWA), a State with final RCRA
authorization administered its
hazardous waste program entirely in
lieu of the EPA administering the
Federal program in that State. The
Federal requirements no longer applied
in the authorized State, and the EPA
could not issue permits for any facilities
in that State, since only the State was
authorized to issue RCRA permits.
When new, more stringent Federal
requirements were promulgated, the
State was obligated to enact equivalent
authorities within specified time frames.
However, the new Federal requirements
did not take effect in an authorized State
until the State adopted the Federal
requirements as State law.
In contrast, under RCRA section
3006(g) (42 U.S.C. 6926(g)), which was
5 Per personal communication with Charlotte
Smith of Waste Management, January 26, 2022, and
email communication with Mike Crisenbery of
Clean Harbors, February 10, 2022.
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added by HSWA, new requirements and
prohibitions imposed under HSWA
authority take effect in authorized States
at the same time that they take effect in
unauthorized States. The EPA is
directed by the statute to implement
these requirements and prohibitions in
authorized States, including the
issuance of permits, until the State is
granted authorization to do so. While
States must still adopt HSWA related
provisions as State law to retain final
authorization, the EPA implements the
HSWA provisions in authorized States
until the States do so.
Authorized States are required to
modify their program only when the
EPA enacts Federal requirements that
are more stringent or broader in scope
than the existing Federal requirements.
RCRA section 3009 allows the States to
impose standards more stringent than
those in the Federal program (see also
40 CFR 271.1). Therefore, authorized
States may, but are not required to,
adopt Federal regulations, both HSWA
and non-HSWA, that are considered less
stringent than or equally as stringent as
the previous Federal regulations.
B. Effect on State Authorization
This final rule finalizes technical
corrections to regulations in 40 CFR
parts 261, 262, and 266 that are being
promulgated in part under the authority
of HSWA, and in part under non-HSWA
authority. Thus, the technical
corrections and clarifications finalized
in this direct final rule that are under
non-HSWA authority would be
applicable on the effective date only in
those States that do not have final
authorization of their base RCRA
programs. However, the technical
corrections to regulations in
§ 262.16(b)(1) are promulgated under
the authority of HSWA and would be
effective on the effective date of this
final rule in all States.
This final rule is considered to be
neither more nor less stringent than the
current standards. Therefore, because of
section 3009 of RCRA, which allows
States to impose more stringent
regulations than the Federal program, as
described in section V.a. of this
preamble, authorized States would not
be required to modify their programs to
adopt the technical corrections
promulgated in this final rule, although
we would strongly urge the States to
adopt these technical corrections to
avoid any confusion or
misunderstanding by the regulated
community and the public.
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VI. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 14094: Modernizing Regulatory
Review
This action is not a significant
regulatory action as defined in
Executive Order 12866, as amended by
Executive Order 14094, and was
therefore not subject to a requirement
for Executive Order 12866 review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new
information collection burden under the
PRA because it does not contain any
information collection activities. OMB
has previously approved the
information collection activities
contained in the existing regulations
and has assigned OMB control numbers
2050–0213, 2050–0202, and 2050–0212.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. This action simply
corrects typographical errors, incorrect
citations, and omissions; provides
clarifications; and makes conforming
changes where they have not been made
previously. We have therefore
concluded that this action will have no
regulatory burden for all directly
regulated small entities.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million
(adjusted annually for inflation) or more
(in 1995 dollars) as described in UMRA,
2 U.S.C. 1531–1538, and does not
significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local, or
tribal governments or the private sector.
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E. Executive Order 13132: Federalism
This action does not have federalism
implications. It will not have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
VerDate Sep<11>2014
16:09 Dec 10, 2024
Jkt 265001
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175. Because the rule does not
make any substantive change, it will not
impose substantial direct costs on Tribal
governments. Thus, Executive Order
13175 does not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
as applying only to those regulatory
actions that concern environmental
health or safety risks that EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order.
Therefore, this action is not subject to
Executive Order 13045 because it does
not concern an environmental health
risk or safety risk. Since this action does
not concern human health, EPA’s Policy
on Children’s Health also does not
apply.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 because it is not a
significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve
technical standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes that these technical
corrections do not concern human
health or environmental conditions and
therefore cannot be evaluated with
respect to potentially disproportionate
and adverse effects on people of color,
low-income populations and/or
indigenous peoples because this final
rule does not create any new regulatory
requirements, but rather clarifies
existing requirements and makes
conforming changes.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and
the EPA will submit a rule report to
each House of the Congress and to the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
PO 00000
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99731
List of Subjects
40 CFR Part 261
Environmental protection,
Administrative practice and procedure,
Air pollution control, Confidential
business information, Hazardous waste,
Intergovernmental relations, Licensing
and registration, Reporting and
recordkeeping requirements.
40 FR Part 262
Environmental protection, Exports,
Hazardous materials transportation,
Hazardous waste, Imports, Labeling,
Packaging and containers, Reporting
and recordkeeping requirements.
40 FR Part 266
Environmental protection, Energy,
Hazardous waste, Recycling, Reporting
and recordkeeping requirements.
Michael S. Regan,
Administrator.
For the reasons set forth in the
preamble, title 40, chapter I of the Code
of Federal Regulations is amended as
follows:
PART 261—IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
1. The authority for part 261
continues to read as follows:
■
Authority: 42 U.S.C. 6905, 6912(a), 6921,
6922, 6924(y) and 6938.
2. Section 261.4 is amended by
revising (e)(1) introductory text to read
as follows:
■
§ 261.4
Exclusions.
(e) * * *
(1) Except as provided in paragraphs
(e)(2) and (4) of this section, persons
who generate or collect samples for the
purpose of conducting treatability
studies as defined in 40 CFR 260.10, are
not subject to any requirement of this
part, 40 CFR parts 262 and 263, or to the
notification requirements of Section
3010 of RCRA, nor are such samples
included in the quantity determinations
of 40 CFR 262.13 and the accumulation
limits in 40 CFR 262.14(a)(3), 40 CFR
262.14(a)(4), and 40 CFR 262.16(b)(1)
when:
*
*
*
*
*
PART 262—STANDARDS APPLICABLE
TO GENERATORS OF HAZARDOUS
WASTE
3. The authority for part 262
continues to read as follows:
■
Authority: 42 U.S.C. 6906, 6912, 6922–
6925, 6937, 6938 and 6939g.
4. Section 262.16 is amended by
revising paragraph (b)(1) to read as
follows:
■
E:\FR\FM\11DER1.SGM
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99732
Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Rules and Regulations
§ 262.16 Conditions for exemption for a
small quantity generator that accumulates
hazardous waste.
(b) * * *
(1) Accumulation limit. The quantity
of acute hazardous waste accumulated
on site never exceeds 1 kilogram (2.2
pounds) and the quantity of non-acute
hazardous waste accumulated on site
never exceeds 6,000 kilograms (13,200
pounds);
*
*
*
*
*
■ 5. Section 262.17 is amended by
revising (a)(8)(i) to read as follows:
§ 262.17 Conditions for exemption for a
large quantity generator that accumulates
hazardous waste.
(a) * * *
(8) * * *
(i) Notification for closure of a waste
accumulation unit. A large quantity
generator must perform one of the
following when closing a waste
accumulation unit, but not all waste
accumulation units:
(A) Place a notice in the operating
record within 30 days after closure
identifying the location of the unit
within the facility (if the waste
accumulation unit is subsequently
reopened, the generator may remove the
notice from the operating record); or
(B) Meet the closure performance
standards of paragraph (a)(8)(iii) of this
section for container, tank, and
containment building waste
accumulation units or paragraph
(a)(8)(iv) of this section for drip pads
and notify EPA following the
procedures in paragraph (a)(8)(ii)(B) of
this section for the waste accumulation
unit.
*
*
*
*
*
PART 266—STANDARDS FOR THE
MANAGEMENT OF SPECIFIC
HAZARDOUS WASTES AND SPECIFIC
TYPES OF HAZARDOUS WASTE
MANAGEMENT FACILITIES
6. The authority for part 266
continues to read as follows:
■
Authority: 42 U.S.C. 1006, 2002(a), 3001–
3009, 3014, 3017, 6905, 6906, 6912, 6921,
6922, 6924–6927, 6934, and 6937.
7. Section 266.508 is amended by
revising paragraph (a)(2)(ii) to read as
follows:
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■
(a) * * *
(2) * * *
(ii) A healthcare facility shipping noncreditable hazardous waste
16:09 Dec 10, 2024
Jkt 265001
[FR Doc. 2024–28802 Filed 12–10–24; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
In FR Doc.
2024–27349 appearing on page 93199 in
the Federal Register of Tuesday,
November 26, 2024, the following
correction is made:
SUPPLEMENTARY INFORMATION:
§ 571.127
[Corrected]
On page 93220, in the first column, in
part 571, in amendment 2.b, the
instruction ‘‘Revising S5.1.1(a)(3) and
(4), S5.1.1(b)(2), S5.1.3, and S8.3.3(g).’’
is corrected to read ‘‘Revising
S5.1.1(a)(3) and (4), S5.1.1(b)(1), S5.1.3,
and S8.3.3(g).’’.
■
49 CFR Part 571
Issued in Washington, DC, under authority
delegated in 49 CFR 1.95 and 501.8.
Raymond R. Posten,
Associate Administrator, Rulemaking.
[Docket No. NHTSA–2023–0021]
[FR Doc. 2024–28998 Filed 12–10–24; 8:45 am]
BILLING CODE P
RIN 2127–AM37
Federal Motor Vehicle Safety
Standards; Automatic Emergency
Braking Systems for Light Vehicles;
Correction
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Final rule; response to petitions
for reconsideration; correction.
50 CFR Part 29
This document corrects a
November 26, 2024 final rule partially
granting petitions for reconsideration of
a May 9, 2024, final rule that adopted
Federal Motor Vehicle Safety Standard
(FMVSS) No. 127, ‘‘Automatic
Emergency Braking for Light Vehicles,’’
which requires automatic emergency
braking (AEB), pedestrian automatic
emergency braking (PAEB), and forward
collision warning (FCW) systems on all
new light vehicles. This document
corrects a typographical error in the
amendatory instructions.
DATES: Effective January 27, 2025.
ADDRESSES: Correspondence related to
this rule should refer to the docket
number set forth above (NHTSA–2023–
0021) and be submitted to the
Administrator, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590.
Permitting of Rights-of-Way Across
National Wildlife Refuges and Other
U.S. Fish and Wildlife ServiceAdministered Lands
AGENCY:
SUMMARY:
For
technical issues: Mr. Markus Price,
Office of Crash Avoidance Standards,
Telephone: (202) 366–1810, Facsimile:
(202) 366–7002. For legal issues: Mr. Eli
Wachtel, Office of the Chief Counsel,
Telephone: (202) 366–2992, Facsimile:
(202) 366–3820. The mailing address for
these officials is: National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590.
FOR FURTHER INFORMATION CONTACT:
§ 266.508 Shipping non-creditable
hazardous waste pharmaceuticals from a
healthcare facility or evaluated hazardous
waste pharmaceuticals from a reverse
distributor.
VerDate Sep<11>2014
pharmaceuticals must write the word
‘‘PHRM’’ or ‘‘PHARMS’’ in Item 13 of
EPA Form 8700–22. A healthcare
facility may also include the applicable
EPA hazardous waste numbers (i.e.,
hazardous waste codes) in Item 13 of
EPA Form 8700–22.
*
*
*
*
*
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[Docket No. FWS–HQ–NWRS–2019–0017;
FF09R50000–XXX–FVRS3451900000]
RIN 1018–BD78
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), are revising
our process for permitting of rights-ofway across National Wildlife Refuge
System lands and other Serviceadministered lands. By aligning Service
processes more closely with those of
other Department of the Interior
bureaus, to the extent practicable and
consistent with applicable law, we will
reduce the amount of time the Service
requires to process applications for
rights-of-way across Service-managed
lands. We will require a preapplication
meeting and use of a standard
application, allow electronic submission
of applications, and provide the Service
with additional flexibility, as
appropriate, to determine the fair
market value or fair market rental value
of rights-of-way across Service-managed
lands. Additionally, we are
implementing new permit terms and
conditions and other regulatory
changes.
SUMMARY:
DATES:
This rule is effective January 10,
2025.
E:\FR\FM\11DER1.SGM
11DER1
]]>Agencies
[Federal Register Volume 89, Number 238 (Wednesday, December 11, 2024)]
[Rules and Regulations]
[Pages 99727-99732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28802]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 261, 262, and 266
[EPA-HQ-OLEM-2023-0081; FRL 8687-04-OLEM]
RIN 2050-AH23
Hazardous Waste Generator Improvements Rule, the Hazardous Waste
Pharmaceuticals Rule, and the Definition of Solid Waste Rule; Technical
Corrections
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
finalizing five amendments that were withdrawn in its December 6, 2023,
partial withdrawal of direct final rule. Due to receipt of adverse
comments, the EPA withdrew eight amendments from the August 9, 2023,
direct final rule that included revisions to the 2016 Hazardous Waste
Generator Improvements Rule, the 2019 Hazardous Waste Pharmaceuticals
Rule and the 2018 Vacatur of the Definition of Solid Waste Rule (88 FR
54086). The EPA is
[[Page 99728]]
responding to the relevant adverse comments in this action.
DATES: This final rule is effective on February 10, 2025.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OLEM-2023-0081. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Kathy Lett, U.S. Environmental
Protection Agency, Office of Resource Conservation and Recovery (MC:
5304T), 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-
0517, ([email protected]) or Kristin Fitzgerald, U.S. Environmental
Protection Agency, Office of Resource Conservation and Recovery (MC:
5304T), 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-
0512 ([email protected]).
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
Entities potentially affected by this action include hazardous
waste generators, treatment, storage, and disposal facilities,
healthcare facilities, reverse distributors, importers/exporters of
hazardous waste, and users of the transfer-based exclusion to the
definition of solid waste. Also affected are States and EPA Regions
implementing these RCRA hazardous waste regulations.
This discussion is not intended to be exhaustive, but rather
provides a guide for readers regarding entities likely to be regulated
by this action. This discussion includes the types of entities that the
EPA is now aware could potentially be regulated by this action. Other
types of entities not included could also be regulated. To determine
whether your entity is regulated by this action, you should carefully
examine the applicability criteria found in Section IV of the preamble.
If you have questions regarding the applicability of this action to a
particular entity, consult the persons listed in the FOR FURTHER
INFORMATION CONTACT section.
B. What action is the agency taking?
This action finalizes five amendments that were included in its
August 9, 2023, direct final rule that made technical corrections to
three rulemakings related to the generation of hazardous waste: the
2016 Hazardous Waste Generator Improvements Rule, the 2019 Hazardous
Waste Pharmaceuticals Rule, and the 2018 Vacatur of the Definition of
Solid Waste Rule (88 FR 54086). Due to receipt of adverse comments,
eight amendments were withdrawn in the EPA's December 6, 2023, partial
withdrawal of direct final rule (88 FR 84710). EPA has evaluated the
comments received on the amendments and is finalizing five of these
amendments, found in Sec. Sec. 261.4(e)(1), 262.16(b)(1),
262.17(a)(8)(i) introductory text, 262.17(a)(8)(i)(A) and
266.508(a)(2)(ii). These five provisions relate to the 2016 Hazardous
Waste Generator Improvements Rule and the 2019 Hazardous Waste
Pharmaceuticals Rule.
Finalizing these technical corrections will correct or clarify the
regulations for generators and handlers of hazardous waste. The EPA is
also responding in this preamble to the adverse comments on the items
that we are finalizing in this action. The three provisions we are not
finalizing will not go into effect with this action and the EPA is not
responding to the adverse comments on these three provisions.
C. What is the agency's authority for taking this action?
This rule is authorized under sections 1004, 2002, 3001, 3002,
3003, 3004, 3005, 3006, and 3010, of the Resource Conservation and
Recovery Act of 1976, as amended, 42 U.S.C. 6903, 6912, 6921, 6922,
6923, 6924, 6925, 6926, and 6930.
III. Background
In the EPA's August 9, 2023, direct final rule (88 FR 54086), EPA
explained that the Agency views the minor fixes and clarifications
included in the action as noncontroversial. However, EPA published a
parallel proposed rule the same day that could serve as the proposed
rule to adopt the provisions in the direct final rule if adverse
comments were received. EPA stated that in this case, there would not
be a second comment period on this action.
The direct final rule preamble also stated that if the Agency were
to receive adverse comment on any individual correction, we would
publish a timely withdrawal in the Federal Register informing the
public about the specific regulatory paragraph or amendment that will
not take effect.
The EPA received adverse comments on eight amendments from the
direct final rule and withdrew them on December 6, 2023 (88 FR 84710).
All corrections that were not withdrawn became effective on December 7,
2023.
IV. Provisions Being Finalized and Response to Comment
A. Section 261.4(e)(1)
The August 9, 2023, direct final rule identified a number of
regulatory citations that were incorrect and outdated in the
regulations for generators of hazardous waste and updated those
citations. Section 261.4(e) provides requirements for management of
samples used in treatability studies and included citations that needed
to be updated. The list of corrections included revising Sec.
261.4(e)(1) to replace the references to quantity determinations in
Sec. Sec. 261.5 and 262.34(d) with a reference to the counting
requirements in Sec. 262.13 and the accumulation limits in Sec.
262.16(b)(1).
EPA received an adverse comment to this revision. The commenter
stated that it appears that the revised citation in this location,
which identifies which categories of generators do not need to count
treatability sample weight towards generator accumulation limits was
incomplete. The comment stated that the revised citation should point
to the accumulation limits for very small quantity generators (VSQGs),
large quantity generators (LQGs), and satellite accumulation areas
(SAAs), not just SQGs.
EPA partially agrees with the commenter and is revising this
citation to include references to Sec. Sec. 262.14(a)(3) and (4), the
accumulation limits for VSQGs accumulating acute and non-acute
hazardous waste. The original language in this section referred to
accumulation limits for VSQGs and SQGs and this revision reestablishes
those two references. Generators accumulating waste at SAAs must
include that waste in their monthly quantities for determining
generator status, but the original regulatory language did not refer to
the SAA requirements and LQGs do not have an accumulation limit. For
these reasons, EPA is not amending the language to add any references
to SAA or LQG requirements.
B. Section 262.16(b)(1)
The 2016 Generator Improvements rule established definitions for
very small, small, and large quantity generators, reorganized the
regulations for these categories of generators, and
[[Page 99729]]
clearly distinguished the generator categories--determined by how much
hazardous waste is generated per calendar month at a site--from the
conditions for exemption that specify limits for how much hazardous
waste small and very small quantity generators can accumulate on site
at any one time.
However, the small quantity generator conditions for exemption
include an on-site accumulation limit of 6,000 kilograms for non-acute
hazardous waste but do not specify an on-site accumulation limit for
acute hazardous waste.
In the original 1980 hazardous waste generator regulations, there
were only two categories of hazardous waste generator: small
(generating less than 1,000 kilograms of hazardous waste per month) and
large (generating more than 1,000 kilograms of hazardous waste per
month). These pre-1986 small quantity generators had a total on-site
hazardous waste accumulation limit of 6,000 kilograms of non-acute
hazardous waste and one kilogram of acute hazardous waste. The 1986
rule that established the category and specific requirements for those
generating between 100 kilograms and 1,000 kilograms per month (small
quantity generators) (51 FR 10146; March 24, 1986) implemented the
changes to the hazardous waste program required by the Hazardous and
Solid Waste Amendments of 1984 (HSWA) and established a new category of
``conditionally exempt small quantity generator'' for those generating
less than 100 kilograms of non-acute hazardous waste per month.
The scope of HSWA and the new regulations for conditionally exempt
small quantity generators did not include acute hazardous waste.
Therefore, generators generating less than one kilogram of acute
hazardous waste per month are conditionally exempt small quantity
generators and those generating more than one kilogram of acute
hazardous waste per month are large quantity generators. There is no
separate small quantity generator category based solely on generation
of acute hazardous waste.
The EPA clarified the distinctions between the three generator
categories in the 2016 Generator Improvements rule and stated that a
small quantity generator can only generate up to one kilogram of acute
hazardous waste in a calendar month, but it was not clear in the new
language whether there is a limit on the amount of acute hazardous
waste a small quantity generator can accumulate on site at any one
time. Consistent with what has been historically allowed for generators
of small amounts of acute hazardous waste since the 1980 regulations,
in the August 2023 technical correction notice, the EPA revised Sec.
262.16(b)(1) to clarify that the acute hazardous waste accumulation
limit for a small quantity generator is one kilogram.
The EPA received an adverse comment on this provision. One
commenter stated that a 1-kilogram limit for small quantity generators
accumulating acute hazardous waste would create severe logistical
issues for facilities that generate just slightly under 1 kilogram per
month of acutely hazardous waste as the proposed rule will essentially
make their allowable accumulation time 30 days. The commenter stated
that it would be ``impossible to collect samples, characterize the
waste, receive disposal approval for the waste and have the waste
transported offsite within the allowable time frame.''
EPA disagrees with the comment. As described in this preamble, a 1-
kilogram accumulation limit for this category of generator was part of
the RCRA regulations starting in 1980 and the revision being made is to
make that clearer in the regulations. The generator regulations are
designed so that if a generator needs additional time to sample,
characterize, and arrange for disposal of an acute hazardous waste that
is accumulating on site, it can operate under the requirements for a
large quantity generator instead of those of a small quantity generator
and remain in compliance with the generator regulations. The additional
large quantity generator standards ensure the safe handling of the
elevated amounts of acute hazardous waste being accumulated at the
generator site.
EPA is finalizing this provision as described in the August 9,
2023, notice.
C. Section 262.17(a)(8)(i) Introductory Text and (a)(8)(i)(A)
The 2016 Hazardous Waste Generator Improvements Rule added a
requirement that LQGs undergoing closure of a hazardous waste unit
submit a notification that they are closing that unit, including
information on the timing of the closure. The generators have two
options for submitting that notification when a specific waste
accumulation unit is closing, but the generator as a whole is not
closing all its units on site (i.e., it will continue generating and
accumulating hazardous waste on site). The 2023 direct final rule
revised the language in Sec. 262.17(a)(8)(i) and (a)(8)(i)(A) to more
clearly describe when the provisions apply and used the defined term
``final closure.'' The preamble to the 2023 direct final rule explained
that EPA made these changes to distinguish between the requirements
that apply when a unit is closing and those that apply when the whole
facility is closing.
EPA received an adverse comment on this revision from a State that
implements hazardous waste regulations. The commenter argued that a
reference to the defined term ``final closure'' in this introductory
text is not appropriate and suggested that EPA instead use the phrase
``undergoing closure of the facility.'' The commenter argues that this
would be more appropriate for a generator closing a waste unit and
needing to follow this requirement.
The commenter also submitted comments on a suggested revision to
Sec. 262.17(a)(8)(i)(A), stating that this part of the closure
regulations would be clearer if the last statement in Sec.
262.17(a)(8)(i)(B) about when a generator can remove a closure notice
from its operating record because a waste accumulation unit was
reopened was moved from Sec. 262.17(a)(8)(i)(B) to Sec.
262.17(a)(8)(i)(A).
EPA agrees that using the term ``final closure'' in this paragraph
adds unnecessary confusion and that the sentence the commenter
identified would make more sense in the revised Sec.
262.17(a)(8)(i)(A). EPA is finalizing revisions to this section to make
those changes and to state that the regulations apply when closing a
waste accumulation unit but not all waste accumulation units.
D. Section 266.508(a)(2)(ii)
The preamble to the 2023 direct final rule explained that EPA was
amending Sec. 266.508(a)(2)(ii) in two ways. First, EPA allowed the
four-character PHRM code as well as the existing six-character PHARMS
code in Item 13 when manifesting non-creditable hazardous waste
pharmaceuticals to a TSDF. This was consistent with guidance EPA issued
in 2019.\1\ Second, EPA inserted a sentence at the end clarifying that
a healthcare facility may choose to include the applicable EPA
hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of EPA
Form 8700-22, in addition to the PHARMS or PHRM code that was already
required. This was consistent with preamble from the Hazardous Waste
Pharmaceuticals final rule.\2\
---------------------------------------------------------------------------
\1\ From Johnson to EPA Regions, December 19, 2019, RCRA Online
#14919.
\2\ 84 FR 5877; February 22, 2019.
---------------------------------------------------------------------------
EPA received one adverse comment on the second provision. The
[[Page 99730]]
commenter was a State that expressed concerns that the rule does not
resolve the issue that the inclusion of RCRA codes with PHRM/PHARMS on
a manifest seems to negate any benefits for a healthcare facility
operating under Subpart P. The State was concerned that a healthcare
facility would be charged a higher fee by those States which collect
fees. The State noted that including PHRM or PHARMS along with RCRA
hazardous waste codes creates confusion and that it is unclear why the
RCRA codes are being listed.
EPA disagrees with the commenter and is finalizing the provision as
proposed. First, with respect to the PHRM code, while we did not
receive any comments on this specific aspect of the proposed amendment,
the adverse comment on other portions of the same paragraph meant that
this was withdrawn, as well. This final rule allows healthcare
facilities to use the PHRM or PHARMS code in Item 13 when manifesting
non-creditable hazardous waste pharmaceuticals.
Second, with respect to hazardous waste codes, this final rule
allows healthcare facilities to include hazardous waste codes in
addition to the PHRM/PHARMS code when manifesting non-creditable
hazardous waste pharmaceuticals. As discussed in a Frequent Question
that is posted to our website,\3\ as well as in a memorandum,\4\ there
are certain situations where the hazardous waste codes need to be
included when manifesting non-creditable hazardous waste
pharmaceuticals. For example, in States that have not yet adopted part
266 subpart P, healthcare facilities are subject to the standard 40 CFR
part 262 generator regulations for their hazardous waste
pharmaceuticals, which require healthcare facilities to include all
applicable waste codes on the manifest. Therefore, if a healthcare
facility that is operating under part 266 subpart P ships non-
creditable hazardous waste pharmaceuticals to a TSDF that is in a State
that has not yet adopted part 266 subpart P, the healthcare facility
would need to include the hazardous waste codes to satisfy the
regulatory requirements in the receiving State. Additionally, some
vendors may require their healthcare facility customers to include the
hazardous waste codes and EPA does not want to preclude that practice
because including all applicable hazardous waste codes could help
receiving facilities better understand the wastes and determine the
best course of management including, for example, complying with the
land disposal restriction treatment standards.
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\3\ https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#e2.
\4\ From Johnson to EPA Regions, December 19, 2019, RCRA Online
#14919.
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Finally, waste industry representatives have told EPA that their
practice is to not commingle hazardous waste pharmaceuticals in the
same container with non-pharmaceutical hazardous wastes.\5\ This means
that when hazardous waste codes are included on the same line of the
manifest as the PHRM/PHARMS code, the hazardous waste codes can be
presumed to be referring to hazardous waste pharmaceuticals, and not to
other, non-pharmaceutical hazardous wastes.
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\5\ Per personal communication with Charlotte Smith of Waste
Management, January 26, 2022, and email communication with Mike
Crisenbery of Clean Harbors, February 10, 2022.
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For these reasons, EPA is finalizing regulatory language that
allows a healthcare facility to include the hazardous waste codes in
Item 13 of the manifest, in addition to the PHRM/PHARMS code.
V. State Authorization
A. Applicability of Rules in Authorized States
Under section 3006 of RCRA, the EPA may authorize a qualified State
to administer its own hazardous waste program within the State in lieu
of the Federal program. Following authorization, the EPA retains
enforcement authority under sections 3008, 3013, and 7003 of RCRA,
although authorized States have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of the EPA administering the
Federal program in that State. The Federal requirements no longer
applied in the authorized State, and the EPA could not issue permits
for any facilities in that State, since only the State was authorized
to issue RCRA permits. When new, more stringent Federal requirements
were promulgated, the State was obligated to enact equivalent
authorities within specified time frames. However, the new Federal
requirements did not take effect in an authorized State until the State
adopted the Federal requirements as State law.
In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which
was added by HSWA, new requirements and prohibitions imposed under HSWA
authority take effect in authorized States at the same time that they
take effect in unauthorized States. The EPA is directed by the statute
to implement these requirements and prohibitions in authorized States,
including the issuance of permits, until the State is granted
authorization to do so. While States must still adopt HSWA related
provisions as State law to retain final authorization, the EPA
implements the HSWA provisions in authorized States until the States do
so.
Authorized States are required to modify their program only when
the EPA enacts Federal requirements that are more stringent or broader
in scope than the existing Federal requirements. RCRA section 3009
allows the States to impose standards more stringent than those in the
Federal program (see also 40 CFR 271.1). Therefore, authorized States
may, but are not required to, adopt Federal regulations, both HSWA and
non-HSWA, that are considered less stringent than or equally as
stringent as the previous Federal regulations.
B. Effect on State Authorization
This final rule finalizes technical corrections to regulations in
40 CFR parts 261, 262, and 266 that are being promulgated in part under
the authority of HSWA, and in part under non-HSWA authority. Thus, the
technical corrections and clarifications finalized in this direct final
rule that are under non-HSWA authority would be applicable on the
effective date only in those States that do not have final
authorization of their base RCRA programs. However, the technical
corrections to regulations in Sec. 262.16(b)(1) are promulgated under
the authority of HSWA and would be effective on the effective date of
this final rule in all States.
This final rule is considered to be neither more nor less stringent
than the current standards. Therefore, because of section 3009 of RCRA,
which allows States to impose more stringent regulations than the
Federal program, as described in section V.a. of this preamble,
authorized States would not be required to modify their programs to
adopt the technical corrections promulgated in this final rule,
although we would strongly urge the States to adopt these technical
corrections to avoid any confusion or misunderstanding by the regulated
community and the public.
[[Page 99731]]
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is not a significant regulatory action as defined in
Executive Order 12866, as amended by Executive Order 14094, and was
therefore not subject to a requirement for Executive Order 12866
review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA because it does not contain any information collection
activities. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control numbers 2050-0213, 2050-0202, and 2050-0212.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action simply corrects typographical errors, incorrect citations, and
omissions; provides clarifications; and makes conforming changes where
they have not been made previously. We have therefore concluded that
this action will have no regulatory burden for all directly regulated
small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million
(adjusted annually for inflation) or more (in 1995 dollars) as
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The action imposes no enforceable
duty on any state, local, or tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175. Because the rule does not make any substantive
change, it will not impose substantial direct costs on Tribal
governments. Thus, Executive Order 13175 does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order.
Therefore, this action is not subject to Executive Order 13045
because it does not concern an environmental health risk or safety
risk. Since this action does not concern human health, EPA's Policy on
Children's Health also does not apply.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
The EPA believes that these technical corrections do not concern
human health or environmental conditions and therefore cannot be
evaluated with respect to potentially disproportionate and adverse
effects on people of color, low-income populations and/or indigenous
peoples because this final rule does not create any new regulatory
requirements, but rather clarifies existing requirements and makes
conforming changes.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects
40 CFR Part 261
Environmental protection, Administrative practice and procedure,
Air pollution control, Confidential business information, Hazardous
waste, Intergovernmental relations, Licensing and registration,
Reporting and recordkeeping requirements.
40 FR Part 262
Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.
40 FR Part 266
Environmental protection, Energy, Hazardous waste, Recycling,
Reporting and recordkeeping requirements.
Michael S. Regan,
Administrator.
For the reasons set forth in the preamble, title 40, chapter I of
the Code of Federal Regulations is amended as follows:
PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
0
1. The authority for part 261 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and
6938.
0
2. Section 261.4 is amended by revising (e)(1) introductory text to
read as follows:
Sec. 261.4 Exclusions.
(e) * * *
(1) Except as provided in paragraphs (e)(2) and (4) of this
section, persons who generate or collect samples for the purpose of
conducting treatability studies as defined in 40 CFR 260.10, are not
subject to any requirement of this part, 40 CFR parts 262 and 263, or
to the notification requirements of Section 3010 of RCRA, nor are such
samples included in the quantity determinations of 40 CFR 262.13 and
the accumulation limits in 40 CFR 262.14(a)(3), 40 CFR 262.14(a)(4),
and 40 CFR 262.16(b)(1) when:
* * * * *
PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE
0
3. The authority for part 262 continues to read as follows:
Authority: 42 U.S.C. 6906, 6912, 6922-6925, 6937, 6938 and
6939g.
0
4. Section 262.16 is amended by revising paragraph (b)(1) to read as
follows:
[[Page 99732]]
Sec. 262.16 Conditions for exemption for a small quantity generator
that accumulates hazardous waste.
(b) * * *
(1) Accumulation limit. The quantity of acute hazardous waste
accumulated on site never exceeds 1 kilogram (2.2 pounds) and the
quantity of non-acute hazardous waste accumulated on site never exceeds
6,000 kilograms (13,200 pounds);
* * * * *
0
5. Section 262.17 is amended by revising (a)(8)(i) to read as follows:
Sec. 262.17 Conditions for exemption for a large quantity generator
that accumulates hazardous waste.
(a) * * *
(8) * * *
(i) Notification for closure of a waste accumulation unit. A large
quantity generator must perform one of the following when closing a
waste accumulation unit, but not all waste accumulation units:
(A) Place a notice in the operating record within 30 days after
closure identifying the location of the unit within the facility (if
the waste accumulation unit is subsequently reopened, the generator may
remove the notice from the operating record); or
(B) Meet the closure performance standards of paragraph (a)(8)(iii)
of this section for container, tank, and containment building waste
accumulation units or paragraph (a)(8)(iv) of this section for drip
pads and notify EPA following the procedures in paragraph (a)(8)(ii)(B)
of this section for the waste accumulation unit.
* * * * *
PART 266--STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES
AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES
0
6. The authority for part 266 continues to read as follows:
Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017,
6905, 6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.
0
7. Section 266.508 is amended by revising paragraph (a)(2)(ii) to read
as follows:
Sec. 266.508 Shipping non-creditable hazardous waste pharmaceuticals
from a healthcare facility or evaluated hazardous waste pharmaceuticals
from a reverse distributor.
(a) * * *
(2) * * *
(ii) A healthcare facility shipping non-creditable hazardous waste
pharmaceuticals must write the word ``PHRM'' or ``PHARMS'' in Item 13
of EPA Form 8700-22. A healthcare facility may also include the
applicable EPA hazardous waste numbers (i.e., hazardous waste codes) in
Item 13 of EPA Form 8700-22.
* * * * *
[FR Doc. 2024-28802 Filed 12-10-24; 8:45 am]
BILLING CODE 6560-50-P
