Rule2023-14731
Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of Solid Waste Rule; Technical Corrections
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 9, 2023
Effective
December 7, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (the EPA or the Agency) is taking direct final action on a number of technical corrections that correct or clarify several parts of the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations. These technical corrections correct or clarify specific provisions in the existing hazardous waste regulations that were promulgated in the Hazardous Waste Generator Improvements rule, the Hazardous Waste Pharmaceuticals rule, and the Definition of Solid Waste rule. This rule also makes other minor corrections that fall within the same sections of the hazardous waste regulations but are independent of these three rules. Examples of the types of corrections being made in this rule include, but are not limited to, correcting typographical errors, correcting incorrect or outdated citations, making minor clarifications, and updating addresses.
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[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Rules and Regulations]
[Pages 54086-54115]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14731]
[[Page 54085]]
Vol. 88
Wednesday,
No. 152
August 9, 2023
Part IV
Environmental Protection Agency
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40 CFR Parts 260, 261, 262, et al.
Hazardous Waste Generator Improvements Rule, the Hazardous Waste
Pharmaceuticals Rule, and the Definition of Solid Waste Rule; Technical
Corrections; Final Rule
Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 /
Rules and Regulations
[[Page 54086]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 260, 261, 262, 264, 265, 266, 270, 271, and 441
[EPA-HQ-OLEM-2023-0081; FRL 8687-02-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: Direct final rule.
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SUMMARY: The Environmental Protection Agency (the EPA or the Agency) is
taking direct final action on a number of technical corrections that
correct or clarify several parts of the Resource Conservation and
Recovery Act (RCRA) hazardous waste regulations. These technical
corrections correct or clarify specific provisions in the existing
hazardous waste regulations that were promulgated in the Hazardous
Waste Generator Improvements rule, the Hazardous Waste Pharmaceuticals
rule, and the Definition of Solid Waste rule. This rule also makes
other minor corrections that fall within the same sections of the
hazardous waste regulations but are independent of these three rules.
Examples of the types of corrections being made in this rule include,
but are not limited to, correcting typographical errors, correcting
incorrect or outdated citations, making minor clarifications, and
updating addresses.
DATES: This rule is effective on December 7, 2023, without further
notice unless the EPA receives adverse comment by October 10, 2023. If
the EPA receives adverse comment on any individual correction, we will
publish a timely withdrawal in the Federal Register informing the
public about the specific paragraph or amendment where the correction
or clarification will not take effect.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information (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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Brian Knieser, U.S. Environmental
Protection Agency, Office of Resource Conservation and Recovery, (MC:
5304T), 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-
0516, (<a href="/cdn-cgi/l/email-protection#6d060304081e081f430f1f040c032d081d0c430a021b"><span class="__cf_email__" data-cfemail="563d383f332533247834243f37381633263778313920">[email protected]</span></a>) or 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, (<a href="/cdn-cgi/l/email-protection#b5d9d0c1c19bded4c1ddccf5d0c5d49bd2dac3"><span class="__cf_email__" data-cfemail="ff939a8b8bd1949e8b9786bf9a8f9ed1989089">[email protected]</span></a>).
SUPPLEMENTARY INFORMATION:
I. Why is EPA using a direct final rule?
The EPA is publishing this rule without a prior proposed rule
because we view this as a noncontroversial action and anticipate no
adverse comment since the technical corrections are minor fixes and
clarifications. However, in the ``Proposed Rules'' section of this
Federal Register publication, we are publishing a separate document
that will serve as the proposed rule to adopt the provisions in this
direct final rule if adverse comments are received on this direct final
rule. We will not institute a second comment period on this action. Any
parties interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document.
If the EPA receives adverse comment on any individual correction,
we will publish a timely withdrawal in the Federal Register informing
the public about the specific regulatory paragraph or amendment that
will not take effect. The corrections that are not withdrawn will
become effective on the date set out above. We would address all public
comments in any subsequent final rule based on comments and new
information submitted in response to the proposed rule.
II. 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 the RCRA hazardous waste regulations.
III. What is the legal authority of this final rule?
This rule is authorized under sections 1004, 2002, 3001, 3002,
3003, 3004, 3005, 3006, 3007, 3010, 3017, and 3018 of the Resource
Conservation and Recovery Act of 1976, as amended, 42 U.S.C. 6903,
6912, 6921, 6922, 6923, 6924, 6925, 6926, 6927, 6930, 6938, and 6939.
IV. Background
In the process of publishing in the Federal Register the three
final rules that are the focus of this rulemaking, the EPA
inadvertently made typographical errors, included incorrect citations,
and finalized language that was unintentionally ambiguous. Similarly,
while the Agency attempted to make conforming changes to all
appropriate parts of the RCRA hazardous waste regulations when these
three rules were promulgated, some were overlooked. The EPA has also
identified a number of other regulations needing to be corrected that
were not part of the three final rules that are the main focus of this
rulemaking but are located in the same sections of the regulations. The
Agency determined that including those additional corrections in this
rulemaking would be an efficient use of Agency resources and provide
sufficient benefit to merit their incorporation. These inadvertent
errors and oversights have been the cause of some confusion on the part
of the regulated community, as well as the Federal and State regulators
implementing the hazardous waste regulatory program. Making these
corrections will ease that confusion among the EPA's stakeholders.
This rule addresses these problems by correcting and clarifying the
RCRA hazardous waste management regulations--specifically the general
hazardous waste management system regulations under 40 CFR part 260,
the hazardous waste identification regulations under 40 CFR part 261;
the standards applicable to generators of hazardous waste in 40 CFR
part 262; the standards for owners and operators of hazardous waste
treatment, storage, and disposal facilities in 40 CFR part 264; the
interim status standards for owner and operators of hazardous waste
treatment, storage, and disposal facilities in 40 CFR part 265; the
regulations for specific hazardous wastes and specific types of
hazardous waste management facilities in 40 CFR part 266, including the
regulations for hazardous waste pharmaceuticals in 40 CFR part 266,
subpart P; the regulations for EPA-administered hazardous waste permit
programs under 40 CFR part 270;
[[Page 54087]]
the requirements for authorization of State hazardous waste programs in
40 CFR part 271; and the dental office point source category
regulations in part 40 CFR part 441.
This action was developed in accordance with EPA guidance on
environmental justice. As a technical correction rulemaking, it does
not have any disproportionately high and adverse human health or
environmental effects on the programs, policies, or activities of
minority populations (people of color) and low-income populations. It
does not have adverse impact on other federal agencies, states, local
governments, tribes, paperwork burdens, or children's health.
Similarly, because this rule consists entirely of technical
corrections, it does not have any adverse impacts on climate change nor
any state and federal climate adaptation programs.
Today's action makes over 100 technical corrections to 40 CFR parts
260-262, 264-266, 270-271, and 441. The discussion of technical
corrections to the regulations below is organized by the rulemaking
that initially made the changes. Where a technical correction does not
stem directly from one of the three main rulemakings being corrected,
it has been included where it makes most sense to do so by topic. In
addition, the EPA provides a description and explanation of the
technical corrections in the preamble to this direct final rule.
V. Corrections Related to the Regulatory Revisions Implemented by the
Hazardous Waste Generator Improvements Rule
This section addresses technical corrections to revisions made as
part of the Hazardous Waste Generator Improvements rule. The final
rule, referred to as the Generator Improvements rule, was published in
the Federal Register on November 28, 2016 (81 FR 85732) and revised the
requirements for hazardous waste generators, a regulatory term that
refers to any person, by site, whose act or process produces hazardous
waste or whose act first causes a hazardous waste to become subject to
regulation. The Generator Improvements rule included a reorganization
and renumbering of the regulations for the management of hazardous
waste by generators of that waste as well as revisions that both closed
regulatory gaps and, where appropriate, provided flexibility in the
regulations for certain management scenarios. The technical corrections
described in this action include the correction of typographical
errors, the correction of citations in the regulations that were not
updated in the original Generator Improvements rule, and revisions to
wording in the regulations that has caused confusion in the six years
since the final rule was published.
The technical corrections in this section of the rule appear mostly
in the hazardous waste generator regulations in part 262 of chapter 40
of the Code of Federal Regulations, but also in other hazardous waste
provisions in 40 CFR parts 260, 261, 264, 265, 266, 270, and 271. There
is also one citation updated in 40 CFR part 441.
Each of the technical corrections are discussed below. The preamble
discusses typographical errors first, then updated citations, and
finally wording changes. Within each section, the technical corrections
are generally discussed in the order they appear in the regulations.
However, to avoid repetition, similar technical corrections are
discussed together in the preamble.
A. Typographical Errors
<bullet> Section 262.16(b) is revised to include a reference to
Sec. 262.16(c) in the list of provisions in this section describing
when a small quantity generator can accumulate hazardous waste for more
than 180 days. The reference to Sec. 262.16(c) was inadvertently left
off this list in the 2016 Generator Improvements rule.
<bullet> Section 262.16(b)(5) is revised to remove an ``of'' from
the paragraph where it does not belong.
<bullet> Sections 262.16(b)(8)(iv)(A) and (B) are both revised to
replace the internal cross reference to paragraph (a)(8)(ii) of this
section to the correct citation: paragraph (b)(8)(ii) of this section.
<bullet> Section 262.17(a)(7)(i)(A) is revised to make the internal
cross reference more specific by including the fourth paragraph level.
The correct cross reference is to Sec. 262.17(a)(7)(iv)(C), which
describes what elements must be included in a large quantity
generator's (LQG) training program. This revision also is consistent
with the cross referencing in Sec. 265.16, which applied to LQGs
before the Generator Improvements rule reorganization.
<bullet> Section 262.17(a)(8)(iii)(A)(4) is revised to correct the
regulation it references. The correct citation is paragraph
(a)(8)(iii)(A)(2) of this section.
<bullet> Section 262.213(a)(1) is revised to replace a misplaced
``or'' with ``of.''
<bullet> Section 262.232(b)(4) is revised to remove the word
``waste'' from a place where it does not belong.
<bullet> Section 262.232(b)(6)(iv) is revised to add ``RCRA-'' to
the term ``designated facility'' to match the language of parallel
provisions in this section.
<bullet> Section 265.71 is revised by removing the comment to
paragraph (c). The contents of that comment were incorporated into the
main text of paragraph (c) by the Generator Improvements rule, but the
comment was not removed at that time.
B. Missed Citation Updates and Changed Terminology
The Generator Improvements rule reorganized the hazardous waste
generator regulations. Two of the main changes during this
reorganization were moving the regulations that had been in Sec. 261.5
into Sec. Sec. 262.13 and 262.14 and reorganizing the regulations that
had been in Sec. 262.34 into three new sections: Sec. 262.15 for
satellite accumulation areas, Sec. 262.16 for small quantity
generators, and Sec. 262.17 for large quantity generators.
The Generator Improvements rule also replaced the Sec. 260.10
defined term ``conditionally exempt small quantity generator''
throughout the regulations with a new term that more accurately
describes this category of generators: ``very small quantity
generator.'' In addition, the rule defined the terms ``small quantity
generator'' and ``large quantity generator.'' The previous regulations
had distinguished small quantity generators from large quantity
generators by stating with each mention that the former were generators
that generated greater than 100 kilograms and less than 1,000 kilograms
of hazardous waste in a calendar month and the latter were generators
that generated equal to or greater than 1,000 kilograms of hazardous
waste per calendar month.
The Generator Improvements rule also removed from the Code of
Federal Regulations several obsolete sections of the generator
regulations that are no longer in effect.
Although the EPA attempted to find each reference to obsolete
regulatory citations and terminology when finalizing the 2016 Generator
Improvements rule, several were missed. The EPA is taking this
opportunity to correct those errors in the regulations and update them
with the new citations and terms or remove the citations completely, if
appropriate. In addition, the EPA is updating one physical address
listed in the regulations.
<bullet> The definition of ``Final closure'' in Sec. 260.10 is
revised to update the citation from Sec. 262.34 to Sec. Sec. 262.16
and 262.17.
<bullet> Section 261.1(a)(1) is revised to remove the reference to
hazardous waste produced by very small quantity generators because the
regulations for
[[Page 54088]]
very small quantity generators are now in part 262.
<bullet> Section 261.4(e)(1) is revised 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).
<bullet> Section 261.11(c) is removed and reserved. The Generator
Improvements rule finalized regulations that directly address generator
category and generation limits for each category; thus, this paragraph
is redundant and could result in confusion if not removed.
<bullet> Section 261.30(d) is revised to replace the reference to
Sec. 261.5 with a reference to Sec. 262.13, Table 1, and the text of
the paragraph is revised to use the same language as the title to Table
1: Generator Category Limits.
<bullet> Three references to Sec. 262.34 in appendix IX to part
261 are replaced with references to Sec. Sec. 262.15, 262.16, and
262.17, as applicable.
<bullet> Section 262.10(k) is revised to replace a reference to
Sec. 262.34 with a reference to Sec. Sec. 262.15-262.17, and the
standards in those sections are identified as conditions for exemption
to be consistent with the rest of the generator standards.
<bullet> Section 262.10, Note 1, is revised to replace two
references to Sec. 262.34 with references to Sec. Sec. 262.15-262.17.
<bullet> Section 262.42(a)(1) and (2) and (b) are revised to
replace descriptions of generator categories (e.g., ``generators of
1000 kilograms or greater of hazardous waste in a calendar month'')
with either ``small quantity generator'' or ``large quantity
generator,'' which were terms promulgated and/or updated in the 2016
Generator Improvements rule.
<bullet> Section 262.82(e)(2) is updated to reflect the current
address for hand deliveries of submittals required in part 262, subpart
H, for transboundary movements of hazardous waste for recovery or
disposal.
<bullet> The definition of ``trained professional'' in Sec.
262.200 is revised to specifically identify the training requirements
that personnel at large, small, and very small quantity generators must
comply with under part 262, subpart K, to be considered a trained
professional.
<bullet> Section 262.212(e)(3) is revised to replace a reference to
Sec. 261.5(c) and (d) with a reference to Sec. 262.13.
<bullet> Section 264.1(g)(3) is revised to add generators that are
accumulating waste on site in compliance with the generator standards
in subparts K and L of part 262 to the list of compliant generators to
which part 264 does not apply.
<bullet> Sections 264.1(g)(12), 265.1(c)(15), and 270.1(c)(2)(ix)
referring to the expired New York State Utility XL project are all
removed and reserved.
<bullet> Section 264.15(b)(5) referring to the expired Performance
Track program is removed and reserved.
<bullet> Section 264.1030(b)(3) is revised to replace a reference
to Sec. 262.34(a) with a reference to Sec. 262.17.
<bullet> Section 264.1050(b)(2) is revised to replace a reference
to Sec. 262.34(a) with a reference to Sec. 262.17.
<bullet> Section 266.100(c)(3) is revised to replace the term
``special requirements'' with ``conditions for exemption''; to replace
the term ``conditionally exempt small quantity generator'' with ``very
small quantity generator''; and to replace a reference to Sec. 261.5
with a reference to Sec. 262.14.
<bullet> Section 266.108 is revised to replace the term ``special
requirements'' with ``conditions for exemption''; to replace the term
``conditionally exempt small quantity generator'' with ``very small
quantity generator''; and to replace a reference to Sec. 261.5 with a
reference to Sec. 262.14.
<bullet> Section 271.10(c) is revised to add a reference to Sec.
262.15 because the previous reference to Sec. 262.34 should have been
updated in the 2016 Generator Improvements rule to also include Sec.
262.15.
<bullet> Section 441.50(b)(3) is revised to replace a reference to
Sec. 261.5(g)(3) with a reference to Sec. 262.14(a)(5).
C. Regulations To Be Reworded
In the time since the 2016 Hazardous Waste Generator Improvements
rule was promulgated, the EPA has received feedback from State
regulators implementing the rule, industry stakeholders, and others
using the rule that some of the changes in the final rule are worded in
a confusing way or could be interpreted as changing how the generator
regulations work when the EPA did not discuss making such changes. In
this section of the preamble, the EPA discusses and explains technical
corrections to the regulations finalized by the 2016 Generator
Improvements rule to address these concerns.
1. Notification Requirements in Section 3010 of RCRA (Multiple
Locations)
In multiple generator provisions promulgated in the 2016 Generator
Improvements rule, the EPA refers to the notification requirements in
section 3010 of the RCRA statute specifically. For example, in some
provisions we state that the requirements for a permitted facility,
including the notification requirements in section 3010 of RCRA, do not
apply to those entities that meet generator conditions for exemption
from permitting. Elsewhere, we state that if a generator violates a
specific condition, such as an LQG accumulating longer than 90 days
without an extension, they become subject to the permitting
requirements, including section 3010 of RCRA.
Since the promulgation of the rule, the EPA has been asked if
regulatory language in the 2016 rule means that a generator of
hazardous waste does not need to notify as a generator using EPA Form
8700-12, the Site ID form. The EPA did not intend this language to have
this meaning--and in fact, small and large quantity generators continue
to have the requirement in Sec. 262.18 to complete and submit the Site
ID form, notifying the EPA and the implementing State that they are in
operation.
The EPA has revised the regulatory text in Sec. Sec. 262.1;
262.10(a)(2); and 262.16; and five places in Sec. 262.17 (Sec.
262.17(b), (c), (d), (e), and (f)) to make it clear that the generators
that are operating in compliance with the generator regulations are
exempted from the notification requirements in section 3010 of RCRA
specifically as they pertain to treatment, storage, and disposal
facilities.
2. Hazardous Waste Determination (Sec. 262.11(d) and (g))
In the 2016 Generator Improvements rule, the EPA made numerous
revisions to the hazardous waste determination regulations in Sec.
262.11 to incorporate long-standing guidance and policy. Section
262.11(c) used to read: ``For purposes of compliance with 40 CFR part
268, or if the waste is not listed in subpart D of 40 CFR part 261, the
generator must then determine whether the waste is identified in
subpart C of 40 CFR part 261 by either . . .''
The 2016 Generator Improvements rule moved this paragraph to Sec.
262.11(d) and reworded the paragraph: ``The person then must also
determine whether the waste exhibits one or more hazardous
characteristics as identified in subpart C of 40 CFR part 261 by
following the procedures in paragraph (d)(1) or (2) of this section, or
a combination of both.''
Rewording the paragraph has led to questions about whether it is
now necessary to identify all characteristics, even when identifying a
listing that already addresses the characteristic. For example, F003
solvents are listed for ignitability. The 2016 revision of Sec.
262.11(d) could be read so that a generator must also identify the D001
characteristic for an F003 spent solvent. This was not our intent. We
have been
[[Page 54089]]
consistent in our interpretation that as long as the listed waste code
addresses the constituents or properties that cause the waste to
exhibit a characteristic, then it is not necessary to also identify the
characteristic. This is still the case. We are adding two sentences to
the end of Sec. 262.11(d) to clarify that we did not change this
interpretation. For the same reason, Sec. 262.11(g) is being revised
to reference Sec. 262.11(d) so they will be consistent with one
another.
3. Very Small Quantity Generators That Accumulate Above the Threshold
(Sec. 262.14(a)(3) and (4))
In the 2016 Generator Improvements rule, the EPA made revisions in
Sec. Sec. 260.10, 262.13, 262.14, and 262.16 to clarify to the
regulated community which regulations apply to hazardous waste
generators based on (1) The quantity of hazardous waste they generate
per month; and (2) the quantity of hazardous waste they accumulate on
site at any given time. Among those revisions were two lists of
standards that apply when a very small quantity generator (VSQG)
exceeds the VSQG limit for hazardous waste accumulated on site at any
one time: one kilogram of acute hazardous waste, 100 kilograms of
residue from a cleanup of a spill of acute hazardous waste, or 1,000
kilograms of non-acute hazardous waste. (See Sec. 262.14(a)(3) and
(4))
Before 2016, these provisions were in Sec. 261.5 and stated that:
(1) Accumulated acute hazardous wastes and residues from clean ups of
spills of acute hazardous waste would be subject to regulation under
parts 262-266, 268, and parts 270 and 124, as well as the applicable
notifications requirements in section 3010 of the RCRA statute, and (2)
non-acute hazardous waste would be subject to the part 262 provisions
applicable to small quantity generator waste, as well as parts 263-266,
268, and parts 270 and 124, and the application notification
requirements in section 3010 of the RCRA statute.
Instead of pointing generators to a long list of provisions that
could apply in these situations, the revised language in the 2016
Generator Improvements rule provided two specific lists of the
provisions that apply to the waste when a VSQG exceeds the accumulation
threshold: one for acute hazardous wastes and one for non-acute
hazardous wastes. However, the lists were focused on the conditions for
exemption, and both left out several provisions that had been covered
by the previous language.
This rule revises both lists--in Sec. 262.14(a)(3) and (4)--to
restore the independent requirements that were inadvertently left out
of the lists, including notification; preparation and use of the
Uniform Hazardous Waste Manifest when shipping the waste off site; and
complying with pre-transport requirements, recordkeeping and reporting
requirements, and transboundary shipment requirements.
A VSQG that is notifying because it exceeded the accumulation
threshold retains its VSQG category and prepares and submits EPA Form
8700-12 (the Site ID form) as a ``very small quantity generator.''
4. Accumulation Limit for Small Quantity Generators Generating Acute
Hazardous Waste (Sec. 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 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 accumulation limit of 6,000 kilograms for non-acute
hazardous waste but do not specify an 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, the EPA is revising Sec.
262.16(b)(1) to clarify that the acute hazardous waste accumulation
limit for a small quantity generator is one kilogram.
5. Accumulation in Tanks (Sec. 262.17(a)(2))
Section 262.17(a)(2) describes the requirements for hazardous waste
that LQGs accumulate in tanks. This section was reorganized with some
wording changes in the 2016 Generator Improvements rule. Section
262.17(a)(2) used to be in Sec. 262.34(a)(1)(ii), where it was clear
that the LQG must comply with the applicable requirements of subparts
J, AA, BB, and CC of 40 CFR part 265 except Sec. Sec. 265.197(c) and
265.200. The EPA was informed by stakeholders that the revised
regulation is not as clear as it had been previously and is therefore
revising the paragraph by replacing the offsetting commas with a set of
parentheses to ensure clarity about which requirements apply to LQGs
that accumulate hazardous waste in tanks.
6. Closure of a Waste Accumulation Unit (Sec. 262.17(a)(8)(i)
Introductory Text and (a)(8)(i)(A))
The Generator Improvements rule added a requirement that LQGs
undergoing closure of a hazardous waste accumulation unit (e.g., tank
system, container accumulation area) must notify the EPA (or the
authorized State). Section 262.17(a)(8)(i) describes the standards for
notification when they are just closing one single accumulation unit
and not all their accumulation units. In this case, LQGs have two
options. They can submit the Site ID form notifying the EPA of a unit's
closure at the time they close the unit (as per Sec.
262.17(a)(8)(i)(B)) or they can put a notice in their operating record
[[Page 54090]]
and then, at a later date, when all the accumulation units are closing,
include the earlier unit in the broader closure notification (as per
Sec. 262.17(a)(8)(i)(A)). The EPA is revising the language in this
section to more clearly describe that these paragraphs apply
specifically to closure of a waste accumulation unit but not the whole
facility.
7. Exception Reporting for an Episodic Event (Sec. 262.232(a)(5))
The 2016 Generator Improvements rule added new provisions and
conditions under subpart L (Alternate Standards for Episodic
Generation) for very small and small quantity generators allowing them
to hold episodic generation events one time per year if they experience
an event that pushes them above the generation threshold for their
normal generator category for that calendar month. (A second event may
be allowed but must be approved by the EPA or the authorizing State.)
Under the episodic event provisions, very small quantity generators
must comply with certain conditions including notification; labeling of
tanks and containers; managing waste in a manner that minimizes fire,
explosions, or releases; and transporting the hazardous waste to a RCRA
treatment, storage, and disposal facility or a hazardous waste recycler
using the Uniform Hazardous Waste Manifest (EPA Form 8700-22). The
intent of these conditions was to ensure that any hazardous waste from
an episodic event is sent to an appropriate hazardous waste designated
facility under the protections of the manifest system.
However, in the regulations finalized by the 2016 Generator
Improvements rule for very small quantity generators holding episodic
events, the EPA neglected to include a reference to Sec. 262.44 of the
generator regulations--recordkeeping requirements for small quantity
generators--an important part of the manifest's cradle-to-grave
tracking. The EPA always intended for the entire manifest tracking
system to apply to hazardous waste from episodic events being held by
very small quantity generators.
The EPA is revising Sec. 262.232(a)(5) to include a reference to
Sec. 262.44, which includes maintaining records of manifests and
hazardous waste determinations, completing an exception report if the
generator does not receive a copy of its manifest from the designated
facility indicating that the waste arrived within 60 days from the date
upon which the waste was accepted by the initial transporter, and
complying with requests from the Administrator for additional reports
under sections 2002(a) and 3002(a)(6) of RCRA.
8. Episodic Generation for Small Quantity Generators (Sec.
262.232(b)(4)(ii)(C))
Section 262.232(b) describes the conditions that apply when a small
quantity generator is holding an episodic event. Generators must label
accumulation units with the date the episodic event begins to ensure
that all hazardous waste from the event is transported off site to a
RCRA-designated facility within the 60 days allowed for the entire
episodic event. This standard was clear in the preamble to the 2016
Generator Improvements final rule and in the parallel regulations for
VSQGs and for small quantity generators accumulating hazardous waste in
containers, but the 2016 regulatory language erroneously indicated that
small quantity generators accumulating hazardous waste in tanks should
mark them with the day the period of accumulation begins (i.e., the day
that hazardous waste started accumulating in that tank), as opposed to
the day the event began. The EPA is revising the regulatory language to
match its intent, as indicated in the 2016 preamble and the other
parallel sections of the episodic generation regulations.
VI. Corrections Related to the Regulatory Revisions Implemented by the
Management Standards for Hazardous Waste Pharmaceuticals and Amendment
to the P075 Listing for Nicotine Rule
This section addresses technical corrections to revisions made as
part of the Management Standards for Hazardous Waste Pharmaceuticals
and Amendment to the P075 Listing for Nicotine rule. The final rule,
referred to as the Hazardous Waste Pharmaceuticals final rule, was
published in the Federal Register on February 22, 2019, (84 FR 5816)
and added part 266 subpart P to title 40, chapter I, of the Code of
Federal Regulations. The revisions described in this action include
correction of typographical errors, the correction of citations in the
regulations that were not updated in the original Hazardous Waste
Pharmaceuticals final rule, revisions to wording in the regulations to
provide consistency, and revisions to wording in the regulations that
have caused confusion in the four years since the final rule was
published.
All but three of the technical corrections appear in part 266,
subpart P. The technical corrections that are not in part 266, subpart
P, are in Sec. Sec. 264.72 and 265.72 and Table 1 of Sec. 271.1. Each
of the technical corrections are discussed below. Generally, the
technical corrections are discussed in the order they appear in the
regulations. However, to avoid repetition, similar technical
corrections are discussed together, even if that means that they are
taken out of order.
A. Manifest Discrepancies (Sec. Sec. 264.72 and 265.72)
Sections 264.72(a)(3) and 265.72(a)(3) are both being revised to
include a reference to the new empty container standards in Sec.
266.507 that were added as a component of part 266, subpart P. The
current regulatory language in Sec. Sec. 264.72(a) and 265.72(a)
references the empty container standards in Sec. 261.7(b). We are
updating the references to include the new empty container standards in
Sec. 266.507 as well.
B. Applicability (Sec. 266.501)
Section 266.501(d)(2) of the Applicability section of part 266,
subpart P, is being amended to correct a typographical error.
Specifically, the regulatory citation Sec. 262.502(a) is being revised
to Sec. 266.502(a). In fact, the citation Sec. 262.502(a) does not
exist.
C. Lab Pack Accumulation (Sec. Sec. 266.502(d)(4) and
266.510(c)(4)(vi))
1. Overview of Technical Corrections Related to Lab Packing Hazardous
Waste Pharmaceuticals
Sections 266.502(d)(4) and 266.510(c)(4)(vi) are both being amended
to insert the phrase, ``or because it is prohibited from being lab
packed due to Sec. 268.42(c).'' Section 266.502(d)(4) is within the
healthcare facility standards for non-creditable hazardous waste
pharmaceuticals. Section 266.510(c)(4)(vi) is within the reverse
distributor standards for evaluated hazardous waste pharmaceuticals.
These changes clarify that non-creditable and evaluated hazardous waste
pharmaceuticals that are prohibited from being lab packed for
incineration must be accumulated in separate containers at healthcare
facilities and reverse distributors, respectively. These amendments are
consistent with guidance the EPA issued after the rule was published in
February 2019 and posted on the web page, Frequent Questions about the
Management Standards for Hazardous Waste Pharmaceuticals and Amendment
to the P075 Listing for Nicotine final rule.\1\
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\1\ <a href="https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#landdisposal">https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#landdisposal</a>.
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[[Page 54091]]
In the Frequent Questions, we explained that in the Hazardous Waste
Pharmaceuticals final rule the EPA required that healthcare facilities
and reverse distributors segregate certain metal-bearing hazardous
waste pharmaceuticals in separate containers. The Agency's reasoning
was that, while combustion is the required treatment standard under the
Land Disposal Restrictions (LDRs) for most hazardous waste
pharmaceuticals, the combustion of a few metal-bearing hazardous wastes
is prohibited. Therefore, a healthcare facility or reverse distributor
must accumulate those particular metal-bearing hazardous waste
pharmaceuticals in a separate container at the initial point of
accumulation, and label them with the appropriate hazardous waste codes
in order to prevent them from being combusted inadvertently. While the
final rule mentions the LDR dilution prohibition as one reason for
accumulating certain metal-bearing hazardous waste pharmaceuticals
separately, we inadvertently omitted a reference to the LDR lab-pack
regulations as a reason for accumulating certain hazardous waste
pharmaceuticals separately.
In Sec. 266.510(c)(4)(vi), we included a parenthetical with an
example of a metal-bearing hazardous waste pharmaceutical that was
prohibited from being combusted due to the dilution prohibition of
Sec. 268.3(c). The example we included was arsenic trioxide. Including
the example caused confusion, leading some to think that arsenic
trioxide was the only metal-bearing hazardous waste pharmaceutical that
had to be segregated. Therefore, we are replacing the example in the
parenthetical with a reference to the complete list of metal-bearing
waste codes in appendix XI to part 268. Similarly, we are adding a
second parenthetical that will reference appendix IV to part 268
following the new language about the lab pack prohibition. For
consistency, we are adding both of these parentheticals to Sec.
266.502(d)(4).
2. Detailed Explanation of Regulatory Changes Related to Lab Packing
Hazardous Waste Pharmaceuticals
The standards for healthcare facilities managing non-creditable
hazardous waste pharmaceuticals include a provision related to metal-
bearing pharmaceuticals that are subject to the dilution prohibition
under the LDRs in Sec. 268.3. Specifically, Sec. 266.502(d)(4) of the
Hazardous Waste Pharmaceuticals final rule states that a ``healthcare
facility may accumulate non-creditable hazardous waste pharmaceuticals
and non-hazardous non-creditable waste pharmaceuticals in the same
container, except that non-creditable hazardous waste pharmaceuticals
prohibited from being combusted because of the dilution prohibition of
Sec. 268.3(c) must be accumulated in separate containers and labeled
with all applicable hazardous waste numbers (i.e., hazardous waste
codes).''
The standards for reverse distributors managing evaluated hazardous
waste pharmaceuticals includes an analogous provision. Specifically,
Sec. 266.510(c)(4)(vi) states that a ``reverse distributor . . . must
. . . [a]ccumulate evaluated hazardous waste pharmaceuticals that are
prohibited from being combusted because of the dilution prohibition of
Sec. 268.3(c) (e.g., arsenic trioxide (P012)) in separate containers
from other evaluated hazardous waste pharmaceuticals at the reverse
distributor.''
The healthcare facility standards and the reverse distributor
standards both cite the LDR dilution prohibition found in Sec.
268.3(c), which provides that ``combustion of the hazardous waste codes
listed in Appendix XI'' to part 268 is ``prohibited, unless the waste,
at the point of generation, or after any bona fide treatment such as
cyanide destruction prior to combustion, can be demonstrated to comply
with one or more'' of the specific criteria (unless otherwise
specifically prohibited from combustion). The criteria follow:
(1) The waste contains hazardous organic constituents or cyanide at
levels exceeding the constituent-specific treatment standard found in
Sec. 268.48;
(2) The waste consists of organic, debris-like materials (e.g.,
wood, paper, plastic, or cloth) contaminated with an inorganic metal-
bearing hazardous waste;
(3) The waste, at point of generation, has reasonable heating value
such as greater than or equal to 5000 BTU per pound;
(4) The waste is co-generated with wastes for which combustion is a
required method of treatment;
(5) The waste is subject to Federal and/or State requirements
necessitating reduction of organics (including biological agents); or
(6) The waste contains greater than 1% Total Organic Carbon (TOC).
Appendix XI to part 268 is a table of 51 metal-bearing hazardous
wastes, some of which are, or are ingredients in, pharmaceuticals. In
some cases, metal-bearing hazardous waste pharmaceuticals contain more
than 1% total organic carbon (TOC), in which case they can be combusted
and they do not need to be accumulated separately (see Sec.
268.3(c)(6)). Other hazardous waste pharmaceuticals that do not contain
more than 1% TOC (or do not meet any other exceptions in Sec. Sec.
268.3(c)(1) through (5)), must be accumulated separately in accordance
with Sec. Sec. 266.502(d)(4) and 266.510(c)(4)(vi) because they are
prohibited from being combusted due to the dilution prohibition.
Arsenic trioxide is an example of a hazardous waste pharmaceutical that
does not contain >1% TOC and therefore must be accumulated separately.
In some cases, a healthcare facility or reverse distributor will
use lab packs for its hazardous waste pharmaceuticals. Lab packs, also
known as ``overpacked drums,'' are a commonly used form of waste
packaging for a variety of hazardous wastes--not just hazardous waste
pharmaceuticals--where many small containers such as vials or bottles
containing compatible hazardous waste are placed into a larger
container with sorbent material. In some cases, lab packs are used by
generators as accumulation containers at the initial point of
accumulation of the hazardous waste. More often, hazardous waste is lab
packed later by a vendor, as the hazardous waste is prepared to be
shipped off site for treatment and disposal. Lab packs are typically
treated by combustion.
In many cases, the use of lab packs by healthcare facilities and
reverse distributors for hazardous waste pharmaceuticals is allowed per
the alternative LDR treatment standard of Sec. 268.42(c), which
provides that, ``as an alternative to the otherwise applicable subpart
D treatment standards, lab packs are eligible for land disposal,''
provided the specific requirements are met. The requirements follow:
(1) The lab packs comply with the applicable provisions of 40 CFR
264.316 and 265.316;
(2) The lab pack does not contain any of the wastes listed in
appendix IV to part 268;
(3) The lab packs are incinerated in accordance with the
requirements of 40 CFR part 264, subpart O, or 40 CFR part 265, subpart
O; and
(4) Any incinerator residues from lab packs containing D004, D005,
D006, D007, D008, D010, and D011 are treated in compliance with the
applicable treatment standards specified for such wastes in subpart D
of part 268.
However, the 17 hazardous wastes codes in appendix IV to part 268
are not eligible for this alternative LDR treatment standard, and thus
are prohibited from being lab packed for incineration (see Sec.
268.42(c)(2)). As shown in the table below, there are
[[Page 54092]]
several hazardous waste pharmaceuticals among the 17 hazardous wastes
listed in appendix IV to part 268. These hazardous waste
pharmaceuticals are prohibited from being included in lab packs that
will be incinerated under the alternative LDR treatment standard;
therefore, the result is that these also must be accumulated
separately, just like the hazardous waste pharmaceuticals that are
prohibited from being incinerated due to the dilution prohibition.
Table 1--Examples of Hazardous Waste Pharmaceuticals Listed in Appendix
IV to Part 268--Wastes Excluded From Lab Packs Under the Alternative
Treatment Standards of Sec. 268.42(c)
------------------------------------------------------------------------
Hazardous waste code Hazardous waste chemical name
------------------------------------------------------------------------
D009 *................................. Mercury (toxicity
characteristic).
P012 *................................. Arsenic Trioxide.
P076................................... Nitric Oxide.
U151 *................................. Mercury.
------------------------------------------------------------------------
* Also appears in Appendix XI to Part 268--Metal Bearing Wastes
Prohibited From Dilution in a Combustion Unit According to 40 CFR
268.3(c).
The regulatory language in Sec. Sec. 266.502(d)(4) and
266.510(c)(4)(vi) is being amended to include this additional cross-
reference to the prohibition on lab packing certain hazardous waste
pharmaceuticals for incineration. The prohibition in Sec. 268.42(c)(2)
applies independent of the changes finalized by the Hazardous Waste
Pharmaceuticals final rule. We are including this additional reference
for clarity and for the reader's convenience.
3. Marking Lab Packs for Shipping
Although there are no corresponding regulatory technical
corrections, we would like to highlight a related matter about marking
lab packs for shipping. Under subpart P, a healthcare facility that is
accumulating and shipping non-creditable hazardous waste
pharmaceuticals to a designated facility is required to mark its
containers with the words ``Hazardous Waste Pharmaceuticals,'' and it
is not necessary to mark those containers with individual hazardous
waste codes (see Sec. 266.502(e)). However, be aware that the shipping
standards for non-creditable and evaluated hazardous waste
pharmaceuticals require that lab packs containing D004 (arsenic), D005
(barium), D006 (cadmium), D007 (chromium), D008 (lead), D010 (selenium)
or D011 (silver) must be marked with the EPA hazardous waste numbers
(see Sec. 266.508(a)(1)(iii)(C)). These specific metals must be
identified because Sec. 268.42(c)(4) requires any incinerator residues
from lab packs that contain any of these specific metals to undergo
further treatment to meet applicable treatment standards prior to land
disposal.
D. EPA Hazardous Waste Numbers (Sec. Sec. 266.502, 266.508, and
266.510)
1. Clarifying Terminology
We are revising the regulatory language in six places to use
consistent language when referring to EPA hazardous waste numbers, and
to consistently reflect that EPA hazardous waste numbers are often
referred to as hazardous waste codes. In each case, the regulatory
language is being revised to read, ``. . . applicable EPA hazardous
waste numbers (i.e., hazardous waste codes).''
The six changes appear in the following four sections of the
regulations:
(1) One change in Sec. 266.502(d)(4);
(2) two changes in Sec. 266.508(a)(1)(iii)(C);
(3) one change in Sec. 266.508(a)(2)(i);
(4) two changes in Sec. 266.510(c)(5).
2. Using Hazardous Waste Codes on the Hazardous Waste Manifest
We are amending Sec. 266.508(a)(2)(ii) to insert a sentence at the
end (using the same phrasing discussed above) clarifying that a
healthcare facility may also include the applicable EPA hazardous waste
numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-12,
in addition to the PHARMS or PHRM code.
This technical correction is a restatement of preamble from the
final rule and is also consistent with guidance that the EPA has
provided since the final rule was published. This change pertains to
the standards for healthcare facilities shipping non-creditable
hazardous waste to a designated facility (e.g., TSDF). The final rule
requires the use of the word ``PHARMS'' on Item 13 of the manifest (see
section VII.M. of this preamble for additional detail). In the preamble
of the final rule, when discussing container labeling standards for
non-creditable hazardous waste pharmaceuticals at healthcare
facilities, the EPA stated that ``the Agency is not finalizing a
requirement of healthcare facilities to label containers of non-
creditable hazardous waste pharmaceuticals with hazardous waste codes,
. . . although a vendor could include such a requirement in its
contract with a healthcare facility.'' \2\
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\2\ 84 FR 5816, February 22, 2019. See page 5877.
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Since then, the EPA reinforced this statement in a Frequent
Question \3\ that is posted on our website, as well as in a
memorandum.\4\ The last paragraph of the memorandum states:
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\3\ <a href="https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#e2">https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#e2</a>.
\4\ From Johnson to EPA Regions, December 19, 2019, RCRA Online
#14919.
Although healthcare facilities operating under subpart P are not
required to include all applicable RCRA hazardous waste codes when
manifesting non-creditable hazardous waste pharmaceuticals, the EPA
indicated in the preamble to the final rule that we do not object if
healthcare facilities or their vendors choose to include RCRA
hazardous waste codes on manifests in addition to PHRM/PHARMS (see
page 5877). Including all applicable RCRA hazardous waste codes on
the manifest when shipping non-creditable hazardous waste
pharmaceuticals could help receiving facilities better understand
the wastes and determine the best course of management. In addition,
we recommend for manifested non-creditable hazardous waste
pharmaceuticals shipped from a healthcare facility operating under
subpart P but passing through a state or going to a TSDF in a state
that has not yet adopted subpart P, that the healthcare facility/
vendor check with those states regarding whether they require all
applicable waste codes to be on the manifest. Further, the regulated
community should be aware that as authorized states adopt and become
authorized for part 266 subpart P, it is possible that they may
choose to be more stringent and require all hazardous waste codes
when healthcare facilities manifest non-creditable hazardous waste
pharmaceuticals.
[[Page 54093]]
E. Calendar Days (Sec. Sec. 266.502 and 266.510)
We are adding the word ``calendar'' to modify the word ``days'' in
15 citations within part 266, subpart P. The word ``calendar'' is
already used to modify the word ``days'' in seven citations within part
266, subpart P, but we were not consistent throughout the subpart P
regulatory language. In the preamble to the proposed and final rules,
however, the term ``calendar days'' is used consistently such that the
EPA believes our intention was clear that whenever ``days'' is
mentioned, it refers to ``calendar days.'' Thus, these 15 regulatory
citations are being amended for clarity and consistency.
Five of the corrected regulatory citations are in the healthcare
facility standards for non-creditable hazardous waste pharmaceuticals
in Sec. 266.502. The other ten corrected regulatory citations are in
the reverse distributor standards for evaluated hazardous waste
pharmaceuticals in Sec. 266.510(c). The 15 citations that are being
amended to include the word ``calendar'' are:
(1) Section 266.502(h);
(2) Section 266.502(h)(3);
(3) Section 266.502(h)(4);
(4) Section 266.502(i)(2)(i)(A);
(5) Section 266.502(i)(2)(ii)(A);
(6) Section 266.510(b)(1);
(7) Section 266.510(b)(2);
(8) Section 266.510(c)(2);
(9) Section 266.510(c)(7);
(10) Section 266.510(c)(7)(iii);
(11) Section 266.510(c)(7)(iv);
(12) Section 266.510(c)(9)(ii)(A)(1);
(13) Section 266.510(c)(9)(ii)(A)(2);
(14) Section 266.510(c)(9)(ii)(B)(1);
(15) Section 266.510(c)(9)(ii)(B)(2).
F. Rejected Shipments (Sec. Sec. 266.502 and 266.510)
We are replacing the word ``returned'' with ``rejected'' in two
places in Sec. 266.502(h) when discussing the procedures for the
management of rejected shipments of non-creditable hazardous waste
pharmaceuticals. Additionally, we are removing the words ``or
returned'' from a third place in Sec. 266.502(h).
This is being done for consistency and clarity. Given that the
title of Sec. 266.502(h) is ``Procedures for healthcare facilities for
managing rejected shipments of non-creditable hazardous waste
pharmaceuticals,'' it is more appropriate to consistently refer to the
rejected loads as ``rejected'' rather than ``returned.'' We are making
identical changes to the procedures for reverse distributors managing
rejected shipment that are in Sec. 266.510(c)(7).
G. Standards for Healthcare Facilities Managing Potentially Creditable
Hazardous Waste Pharmaceuticals (Sec. 266.503)
We are amending Sec. 266.503(b)(1) to be consistent with Sec.
266.502(l)(1). Sections 266.502(l)(1) and 266.503(b)(1) each contain
one of the conditions that receiving healthcare facilities must meet
when accepting hazardous waste pharmaceuticals from an off-site VSQG
healthcare facility. Section 266.502 pertains to non-creditable
hazardous waste pharmaceuticals, while Sec. 266.503 pertains to
potentially creditable hazardous waste pharmaceuticals. For the
reader's convenience, when drafting Sec. 266.502(l)(1), we included a
parenthetical with the definition of ``control,'' but we did not do the
same in Sec. 266.503(b)(1). We are amending Sec. 266.503(b)(1) to
include the same parenthetical with the definition of ``control'' that
appears in Sec. 266.502(l)(1). In both cases, the definition of
``control'' originates from an exclusion from the definition of solid
waste that appears in Sec. 261.4(a)(23)(i)(B).
H. Off-Site Collection of Hazardous Waste Pharmaceuticals Generated by
Healthcare Facilities That Are VSQGs That Are Not Operating Under Part
266, Subpart P (Sec. 266.504)
There are three changes to Sec. 266.504. First, the heading of
Sec. 266.504 is being amended by adding ``that are not operating under
this subpart.'' Since part 266, subpart P, was published in 2019, there
has been some confusion about the applicability of Sec. 266.504. A
healthcare facility must count all of its hazardous waste generated in
a calendar month--including hazardous waste pharmaceuticals--in
determining whether it is required to operate under part 266, subpart
P. A healthcare facility that generates above VSQG amounts of hazardous
waste must operate under subpart P. A healthcare facility that
generates below VSQG amounts of hazardous waste is not required to
operate under subpart P, but may choose to opt in. While the preamble
to the final rule made it clear that all of the optional provisions in
Sec. 266.504 only apply to VSQG healthcare facilities that have not
opted into part 266, subpart P,\5\ the heading was not as clear.
Therefore, we are amending the heading of Sec. 266.504 to make it
clear that the four optional provisions in Sec. 266.504 are only
available to VSQG healthcare facilities that have not opted into
subpart P and therefore are not operating under subpart P. Conversely,
a VSQG healthcare facility that opts into part 266, subpart P, would no
longer be able to use the optional provisions in Sec. 266.504.
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\5\ See 84 FR 5858; February 22, 2019.
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We reiterate that a VSQG healthcare facility that elects to use any
of the optional provisions in Sec. 266.504 will not be considered to
be opting into part 266, subpart P, and does not need to notify as a
healthcare facility.
The second change to Sec. 266.504 is correcting the spelling of
off site. In Sec. 266.504(b), the word ``off-site'' appears twice. The
first time it appears it is correctly hyphenated because it is
modifying the word ``collection.'' However, the second time it appears
it is incorrectly hyphenated because it is being used as a noun.
Section 266.504(b) is being revised to remove the hyphen from the word
``off-site'' the second time it appears, so that ``off-site'' becomes
``off site.''
The third change is that Sec. 266.504(b) is being amended by
replacing the term ``healthcare facility'' with the word ``generator''
toward the end of the paragraph. Normally the RCRA regulations do not
allow a generator to send its waste off site to another generator.
However, in the 2015 Generator Improvements proposed rule, we included
a provision to allow VSQGs to consolidate their hazardous waste off
site at a large quantity generator, provided certain conditions are
met. The Hazardous Waste Pharmaceuticals rule, which was published the
same day as the Generator Improvements proposed rule, included a
similar off-site consolidation provision. Specifically, in the
Hazardous Waste Pharmaceuticals rule we proposed Sec. 266.504(b) to
allow a healthcare facility that is a VSQG to send its hazardous waste
pharmaceuticals off site to another healthcare facility provided
certain similar conditions are met. When the Generator Improvements
final rule was published on November 28, 2016, we finalized the off-
site consolidation provision. When we finalized the Hazardous Waste
Pharmaceuticals final rule on February 22, 2019, we provided options
within the off-site consolidation provision of Sec. 266.504(b),
allowing VSQG healthcare facilities to use either version of the off-
site consolidation provision: the version in the Generator Improvements
final rule, or the version in the Hazardous Waste Pharmaceuticals final
rule. As stated in the preamble of the Hazardous Waste Pharmaceuticals
final rule, we included ``added flexibility for VSQGs to meet the
consolidation provisions that were added as part of the 2016 Hazardous
Waste Generator Improvements final
[[Page 54094]]
rule in lieu of the subpart P off-site consolidation provisions. In
this case, the receiving LQG would have to meet the conditions in Sec.
262.17(f) while the VSQG healthcare facility would have to meet the
conditions in Sec. 262.14(a)(5)(viii).'' The regulations in Sec.
266.504(b) state (emphasis added), ``A healthcare facility that is a
very small quantity generator for both hazardous waste pharmaceuticals
and non-pharmaceutical hazardous waste may send its hazardous waste
pharmaceuticals off-site to another healthcare facility, provided [. .
.].'' The final rule included two options for complying with the off-
site consolidation provisions and they are set out in Sec.
266.504(b)(1) and (2).
In adding these options, however, we neglected to remove the term
``healthcare facility'' from the introductory text of paragraph (b)
when describing to whom the VSQG could send its hazardous waste
pharmaceuticals. If a VSQG healthcare facility is using the subpart P
off-site consolidation option described in Sec. 266.504(b)(1), then it
must send its hazardous waste pharmaceuticals to a healthcare facility
that is operating under subpart P. On the other hand, if a VSQG
healthcare facility is using the off-site consolidation option
described in Sec. 266.504(b)(2), then it must send its hazardous waste
pharmaceuticals to an LQG that meets the conditions under Sec.
262.17(f). It was not our intention to require the receiving LQG to be
a healthcare facility. Therefore, we are removing the term ``healthcare
facility'' from the final line of Sec. 266.504(b) and replacing it
with the word ``generator.''
I. Prohibition on Sewering Hazardous Waste Pharmaceuticals (Sec.
266.505)
The second and final sentence of Sec. 266.505 currently reads,
``Healthcare facilities and reverse distributors remain subject to the
prohibitions in 40 CFR 403.5(b)(1).'' We are revising the citation 40
CFR 403.5(b)(1) to 40 CFR 403.5(b). Section 403 is part of the Clean
Water Act (CWA) regulations; specifically, it is part of the Effluent
Guidelines and Standards. Section 403.5 is entitled ``National
pretreatment standards: Prohibited discharges.'' Section 403.5(b)
includes a list of eight ``Specific prohibitions.'' Healthcare
facilities and reverse distributors remain subject to all the
prohibitions in 40 CFR 403.5(b), not just the prohibition in 40 CFR
403.5(b)(1). The cross-reference to the CWA regulations did not appear
in the proposed rule; we added it into the final regulations in
response to comments. In the preamble to the final rule, we used the
correct citation, Sec. 403.5(b).\6\
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\6\ 84 FR 5816, February 22, 2019. See preamble on page 5894.
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J. Conditional Exemption for Hazardous Waste Pharmaceuticals That Are
Also Controlled Substances (Sec. 266.506)
We are revising the title of Sec. 266.506 and paragraph (a)(2) of
Sec. 266.506 to remove the reference to take-back events or programs.
There are several methods of providing household pharmaceutical take-
backs. For example, retail pharmacies can amend their DEA registration
to become DEA authorized collectors and install collection receptacles
(often referred to as kiosks) for take-back of household
pharmaceuticals. Another example is DEA's very popular national take-
back days that are scheduled for the last Saturday in April and October
each year. ``Take-back events'' and ``take-back programs'' are terms
that are typically used to refer to take-back methods that require the
involvement of law enforcement. Subpart P applies to healthcare
facilities (e.g., retail pharmacies) and reverse distributors; it does
not apply to law enforcement. Since subpart P does not apply to law
enforcement, we should not have included a reference to take-back
methods that involve law enforcement. Therefore, to help reduce
confusion, we are removing the reference to take-back events and
programs.
Our memorandum from September 11, 2018, for law enforcement
conducting take-backs, continues to apply. It explains the regulatory
status of household pharmaceuticals collected by law enforcement and
the type of permitted incinerators that may be used to destroy the
collected household pharmaceuticals.\7\ We are also revising Sec.
266.506(b)(3) to replace the periods with ``; or'' after paragraphs
(b)(3)(iii) and (iv) to be consistent with how the rest of the list is
punctuated.
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\7\ From Wheeler to U.S. Law Enforcement, September 11, 2018,
RCRA Online #14906.
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K. Residues of Hazardous Waste Pharmaceuticals in Empty Containers
(Sec. 266.507)
We are making several corrections and clarifications to the empty
container standards in Sec. 266.507. Each is explained separately
below.
1. Intravenous (IV) Bags
The first sentence of Sec. 266.507(c) defines when an IV bag is
considered ``RCRA empty''; that is, when the contents have been fully
administered to a patient. The second sentence of Sec. 266.507(c) sets
out how IV bags that are not RCRA empty must be managed. At the end of
the second sentence, however, we include a clause that references the
Sec. 261.7(b)(1) definition of ``RCRA empty'' and we allow it to be
used as an alternative, but only for IV bags that contain non-acute
hazardous waste pharmaceuticals. We are moving the clause that
references Sec. 261.7(b)(1) to the end of the first sentence so the
first sentence of Sec. 266.507(c) will include both definitions of
when an IV bag is considered RCRA empty.
2. Other Containers, Including Delivery Devices
We are amending the opening of Sec. 266.507(d) by inserting the
words ``At healthcare facilities operating under this subpart.'' We are
making this change for two reasons. First, while Sec. 266.507(a)
through (c) pertain to specific types of containers at healthcare
facilities, Sec. 266.507(d) is a catch-all for other types of
containers (including delivery devices) at healthcare facilities that
are not addressed specifically by paragraphs (a) through (c). Given
that the new definitions of ``empty containers'' in Sec. 266.507 apply
beyond healthcare facilities and reverse distributors operating under
subpart P, ``other containers'' could be read very broadly to include
large containers of hazardous waste pharmaceuticals, such as 55-gallon
drums. This was not our intent. Rather, our intent with Sec.
266.507(d) was to address ``other containers'' that are commonly found
in the healthcare setting. This is clear from the examples we include
at the end of Sec. 266.507(d): inhalers, aerosol cans, nebulizers,
tubes of ointments, gels, or creams.
The second reason we are amending the opening of Sec. 266.507(d)
is to clarify that it does not apply to healthcare facilities that are
VSQGs, unless the VSQG healthcare facility has opted into subpart P.
The current regulatory language in Sec. 266.507(d) could be read to
mean that any entity, including healthcare facilities that are VSQGs,
must manage their non-empty containers of hazardous waste
pharmaceuticals as non-creditable hazardous waste pharmaceuticals, even
if they are not operating under subpart P. This was not our intent.
Healthcare facilities that are VSQGs have the option of operating under
subpart P with respect to their hazardous waste pharmaceuticals,
including their non-empty containers.
3. Managing Non-Empty Containers
For a similar reason, we are inserting the words ``At healthcare
facilities operating under this subpart'' into the second sentence of
both Sec. 266.507(b)
[[Page 54095]]
and (c). While the revised definitions of ``empty containers'' in Sec.
266.507 apply to any hazardous waste generator, regardless of whether
it is a healthcare facility operating under subpart P, the portions of
Sec. 266.507(b) through (d) that address how to manage non-empty
containers of hazardous waste pharmaceuticals only apply to a
healthcare facility operating under subpart P. If a reverse distributor
is using the revised definitions of ``empty containers'' in Sec.
266.507, it must manage non-empty containers as evaluated hazardous
waste pharmaceuticals. If another type of facility is using the revised
definitions of ``empty containers'' in Sec. 266.507 and is not
operating under subpart P, it must continue to manage non-empty
containers as hazardous waste, under the applicable regulations (e.g.,
part 262).
Finally, we note that a pharmaceutical in a non-empty container
(stock, dispensing and unit-dose; syringe; IV bag; or ``other
container'') may meet the definition of ``potentially creditable
hazardous waste pharmaceutical,'' if it has a reasonable expectation of
receiving manufacturer credit and is:
<bullet> In its original manufacturer packaging;
<bullet> undispensed, and
<bullet> unexpired or less than one year past expiration.
A non-empty container could include either a full, unopened
container or a partial container. If the hazardous waste pharmaceutical
does meet the definition of ``potentially creditable,'' Sec. 266.507
does not preclude a non-empty container with a potentially creditable
hazardous waste pharmaceutical from being sent to a reverse
distributor. After a reverse distributor evaluates the potentially
creditable hazardous waste pharmaceuticals for manufacturer credit, the
reverse distributor must manage them as evaluated hazardous waste
pharmaceuticals.
L. Radio Frequency Identification (Sec. Sec. 266.508 and 266.510)
We are revising Sec. Sec. 266.508(a)(1)(iii)(C) and 266.510(c)(5)
to insert the noun ``tag'' following the phrase ``radio frequency
identification.'' Section 266.508 is standards for shipping non-
creditable hazardous waste pharmaceuticals from a healthcare facility
or evaluated hazardous waste pharmaceuticals from a reverse
distributor. Section 266.510(c) is standards for reverse distributors
managing evaluated hazardous waste pharmaceuticals. In both cases, we
used the modifying phrase ``radio frequency identification'' without
including the noun to which it applied, and so we are now including the
noun ``tag.''
M. PHARMS Code (Sec. 266.508)
When part 266, subpart P, was promulgated, the EPA required
healthcare facilities to use the word ``PHARMS'' on Item 13 of the
manifest for non-creditable hazardous waste pharmaceuticals being
shipped to a designated facility (e.g., TSDF). As explained in the
preamble to the final rule (see 84 FR 5909), we used six characters
because the e-Manifest system can accommodate six characters, and
because PHARMS communicates the nature of the waste. However, since the
final rule was published, the EPA became aware of two issues related to
using six characters. First, although the e-Manifest system can
accommodate six characters and PHARMS can be selected from a
prepopulated menu within the e-Manifest system, most generators are
currently initiating shipments using paper manifests, not fully
electronic manifests. The paper manifest was designed to accommodate
four-character hazardous waste codes which has made it difficult to fit
the entire PHARMS code in the box without exceeding the allotted space.
Second, some States and industry stakeholders have told us that their
databases are not designed to accommodate six characters, which means
that a redesign of their database is required for them to exchange data
with the EPA's e-Manifest system.
To assist implementation, the EPA issued a memorandum on this issue
allowing the use the four-character code PHRM on both paper manifests
and electronic manifests when shipping non-creditable hazardous waste
pharmaceuticals under subpart P.\8\ This four-character code achieves
the same result as the six-character code; therefore, either code
satisfies the requirement at Sec. 266.508(a)(2)(ii). The EPA is now
amending the regulations to be consistent with the guidance included in
the memorandum.
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\8\ Johnson to Land, Chemicals and Redevelopment Division
Directors, December 19, 2019, RCRA Online #14919.
---------------------------------------------------------------------------
Both PHRM/PHARMS codes have been and will continue to be available
for use in the e-Manifest system, with identical ``Hazardous Waste
Pharmaceuticals'' descriptions.
This change is also consistent with guidance the EPA included in
the Hazardous Waste Pharmaceuticals final rule Frequent Questions web
page.\9\
---------------------------------------------------------------------------
\9\ <a href="https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#e1">https://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-and#e1</a>.
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N. Reverse Distributor Standards (Sec. 266.510)
1. Unauthorized Waste Reports
When a reverse distributor receives waste from off site that it is
not authorized to receive (e.g., non-pharmaceutical hazardous waste or
regulated medical waste), it must submit an unauthorized waste report
to the EPA Regional Administrator (or authorized State) within 45
calendar days. Section 266.510(a)(9)(i)(A) through (F) includes the
list of elements that must be included in an unauthorized waste report.
Paragraph (a)(9)(i)(C) of Sec. 266.510 specifies that the EPA
identification number, name, and address of the healthcare facility
that shipped the unauthorized waste must be included in the report, if
available. However, healthcare facilities are not the only entities
that may ship to a reverse distributor. Other reverse distributors may
also ship to a reverse distributor. Further, because this section
addresses situations of non-compliance, it is possible that a reverse
distributor could wrongly receive a shipment from another entity that
includes unauthorized waste. Therefore, we are revising Sec.
266.510(a)(9)(i)(C) by adding the parenthetical ``(or other entity)''
after healthcare facility, to reflect that possibility.
2. Hazardous Waste Numbers
Section 266.510(c)(5) applies to reverse distributors, and states
``[P]rior to shipping evaluated hazardous waste pharmaceuticals off
site, all containers must be marked with the applicable [EPA] hazardous
waste numbers (i.e., hazardous waste codes).'' Earlier in this
preamble, we explained the addition of ``EPA'' prior to ``hazardous
waste numbers,'' wherever it appears in subpart P.
Section 266.508(a)(1)(iii)(C) allows for an exception to having to
mark containers with the applicable hazardous waste numbers.
Specifically, it allows that lab packs that will be incinerated in
compliance with Sec. 268.42(c) are not required to be marked with EPA
hazardous waste numbers, except D004, D005, D006, D007, D008, D010, and
D011, where applicable.
In Sec. 266.510(c)(5), we are adding a cross-reference to the lab
pack marking exception in Sec. 266.508(a)(1)(iii)(C). The exception
for marking lab packs with most EPA hazardous waste numbers applies
regardless of this addition; nevertheless, we are adding the cross-
reference for clarity and to aid the reader.
[[Page 54096]]
3. Reporting by a Reverse Distributor for Evaluated Hazardous Waste
Pharmaceuticals
Section 266.510(c)(9)(ii) includes instructions for how a reverse
distributor must file an exception report when it is missing a copy of
the manifest for evaluated hazardous waste pharmaceuticals that it
shipped to a designated facility.
Section 266.510(c)(9)(ii)(B) addresses the situation when a
shipment is rejected by the designated facility and is shipped to an
alternate facility. Paragraph (c)(9)(ii)(B)(2)(i) of Sec. 266.510
states that a legible copy of the manifest for which the generator does
not have confirmation of delivery must be included in the exception
report. When the EPA adapted the generator exception reporting
regulations for reverse distributors, we neglected to revise
``generator'' to ``reverse distributor,'' as we had intended. We are
now revising the regulations to replace the word ``generator'' with
``reverse distributor.''
O. Hazardous and Solid Waste Amendments of 1984 (Sec. 271.1)
Table 1 in Sec. 271.1 includes a list of RCRA Subtitle C
regulations that have been added pursuant to HSWA. As the EPA explained
in the preamble to the Hazardous Waste Pharmaceuticals final rule, the
sewer prohibition was added to part 266, subpart P, pursuant to HSWA;
\10\ however, the EPA neglected to update Table 1 in Sec. 271.1. This
omission has no bearing on whether the sewer prohibition is considered
a HSWA provision since the statute and preamble to the Pharmaceuticals
final rule make clear that it is. For the sake of completeness and
convenience to the reader, however, the EPA is making a technical
correction to update Table 1 in Sec. 271.1, with the addition of a row
to add the Hazardous Waste Pharmaceuticals final rule and which will
appear in chronological order.
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\10\ 84 FR 5816, February 22, 2019. See pages 5892 and 5936.
---------------------------------------------------------------------------
P. Correction to a Preamble Statement in the Hazardous Waste
Pharmaceuticals Final Rule
When discussing the management of residues in pharmaceutical
containers in the preamble to the Hazardous Waste Pharmaceuticals final
rule, we cited an EPA memorandum from November 2011, with the subject
``Containers that Once Held P-Listed Pharmaceuticals.'' \11\ On page
5903 of the preamble to the final rule, we stated:
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\11\ Rudzinski to RCRA Division Directors, November 11, 2011,
RCRA Online #14827.
---------------------------------------------------------------------------
This guidance was intended as a short-term solution that worked
within the confines of the existing RCRA hazardous waste regulations .
. . Today's new ``empty container'' regulations in Sec. 266.507 will
replace the November 2011 guidance as it pertained to residues of
hazardous waste pharmaceuticals in containers, although the memo will
remain in effect for non-pharmaceutical hazardous wastes.
In this rule, we are clarifying that while there are portions of
the November 2011 memorandum that were made moot by the final rule,
there are other portions of the November 2011 memorandum that are still
valid with respect to acute (P-listed) hazardous waste pharmaceuticals.
The November 2011 memorandum provided guidance about containers
that once held P-listed pharmaceuticals outlining three regulatory
approaches for generators:
(1) Count only the weight of the hazardous waste residues toward
their monthly generator category determination;
(2) Demonstrate an equivalent removal method to triple rinsing to
render containers RCRA empty; and
(3) In the case of warfarin, show that the concentration in the
residue is below the P-listed concentration.
1. Portion of the November 11, 2011, Memorandum That Is Still Valid
With Respect to Acute Hazardous Waste Pharmaceuticals
The first approach outlined in the memorandum states that it is
only necessary to count the weight of the actual hazardous waste, not
the weight of the container holding the hazardous waste. This approach
is not relevant to reverse distributors, because all reverse
distributors must operate under subpart P, regardless of the amount of
hazardous waste pharmaceuticals that are on site. On the other hand,
this is still an allowable approach for a healthcare facility managing
P-listed pharmaceutical waste, although it is probably only useful to a
limited universe of healthcare facilities. The reason its utility is
limited is that all healthcare facilities operating under subpart P are
regulated the same as each other with respect to their hazardous waste
pharmaceuticals. Put another way, there are no generator categories
under subpart P. As a result, if a healthcare facility is operating
under subpart P, it is not necessary to count the weight of the
hazardous waste pharmaceuticals that it generates each month. If,
however, a healthcare facility is not operating under subpart P, then
this approach might be useful to determine whether it is required to
operate under subpart P or prove that it is a VSQG and therefore not
required to operate under subpart P (likewise, other generators might
find this approach useful to determine whether they are required to
operate as SQGs or LQGs under part 262 or prove that they are VSGQs). A
healthcare facility must operate under subpart P for its hazardous
waste pharmaceuticals if it generates more than VSQG amounts of any
hazardous waste (i.e., more than 1 kilogram of acute hazardous waste or
more than 100 kilogram of non-acute hazardous waste per calendar
month). Including the weight of containers may impact whether a
healthcare facility exceeds the 1 kilogram acute hazardous waste
monthly threshold, and, in turn, the requirement to operate under
subpart P.
Note that if a container is considered RCRA empty, the residues are
not regulated as hazardous waste; therefore, it is not necessary to
count the weight of the P-listed pharmaceutical residues or the weight
of the container. On the other hand, if a container is not RCRA empty,
the residues are regulated as RCRA hazardous waste. For non-empty
containers, it is only necessary to count the weight of the P-listed
pharmaceutical residues, not the weight of the container. If a
healthcare facility has containers of P-listed pharmaceutical waste
that are not RCRA empty and is determining whether it is subject to
subpart P, it may be useful for a healthcare facility to count only the
weight of the P-listed acute hazardous waste and not count the weight
of the container.
2. Portions of the November 11, 2011, Memorandum That Have Been
Superseded With Respect to Acute Hazardous Waste Pharmaceuticals
In contrast, the second and third approaches outlined in the
November 2011 memorandum have been superseded by the hazardous waste
pharmaceuticals final rule. The reason each approach has been made moot
by the rule is explained separately below.
The second approach in the November 2011 memorandum for managing
containers that held P-listed pharmaceuticals could have been used to
demonstrate an equivalent removal method to render containers RCRA
empty. This was an existing regulatory mechanism that was offered as an
alternative to triple rinsing containers to render them RCRA empty.
Section 261.7(b)(3)(i) specifies that a container that held an acute
hazardous waste is
[[Page 54097]]
empty if the container (or inner liner) has been triple rinsed using an
appropriate solvent. Section 261.7(b)(3)(ii) offers an alternative
whereby a container that held an acute hazardous waste is empty if the
container (or inner liner) has been ``cleaned by another method that
has been shown in the scientific literature, or by tests conducted by
the generators, to achieve equivalent removal.'' Section 266.507 of
subpart P makes Sec. 261.7(b)(3) moot for hazardous waste
pharmaceuticals. That is because under Sec. 266.507, triple rinsing
(or an equivalent method) is either not required, or not allowed,
depending on the type of container:
(1) Stock, dispensing and unit-dose containers: triple rinsing is
not required to meet the definition of ``RCRA empty'' for a container
that held an acute hazardous waste pharmaceutical. For these types of
containers, a container is considered RCRA empty if the pharmaceuticals
have been removed from the container using practices commonly employed
to remove materials of that type from the container. For these types of
containers, the definition of ``empty'' is the same for all
pharmaceuticals, including P-listed pharmaceuticals.
(2) Syringes: triple rinsing is not required to meet the definition
of ``RCRA empty'' for a syringe that held an acute hazardous waste
pharmaceutical. For syringes, the syringe is considered RCRA empty if
the plunger of the syringe has been fully depressed. For syringes, the
definition of ``empty'' is the same for all pharmaceuticals, including
P-listed pharmaceuticals.
(3) IV bags: triple rinsing of IV bags with acute hazardous waste
pharmaceuticals is not allowed. If the P-listed pharmaceutical in the
IV bag has not been completely administered, a healthcare facility
operating under subpart P must manage it as a non-creditable hazardous
waste pharmaceutical.
(4) Other containers: triple rinsing ``other containers'' of acute
hazardous waste pharmaceuticals is not allowed and there is no method
to make such containers RCRA empty. A healthcare facility operating
under subpart P must manage a P-listed drug in an ``other container''
as a non-creditable hazardous waste pharmaceutical.
The third approach in the November 2011 memorandum for managing
containers that held P-listed pharmaceuticals pertains only to
warfarin, which is one of the two concentration-based P-listings. When
warfarin is present at concentrations greater than 0.3%, it is an acute
hazardous waste with the waste code P001. When warfarin is present at
concentrations at or below 0.3%, it is a non-acute hazardous waste with
the waste code U248. The memorandum offered the option of showing that
the concentration in the residue in the container is below the P-listed
concentration. Our thinking was that perhaps the residues would consist
primarily of a non-warfarin coating on the outside of the pills, rather
than warfarin itself, and thus the residue might have a concentration
of warfarin that would be U-listed. Whether the warfarin is P-listed or
U-listed was relevant because it drove the method that must be used to
render the container RCRA empty. That is, under Sec. 261.7, if the
residues remaining in the container were U248 instead of P001, then the
container would not need to be triple rinsed to render it RCRA empty.
Under subpart P, however, triple rinsing is no longer required to
render a warfarin container RCRA empty, so it is now unnecessary to
demonstrate that the residues are U-listed rather than P-listed.
VII. Corrections to 40 CFR Part 261 Identification and Listing of
Hazardous Waste
This section addresses technical corrections to the changes made in
response to a partial vacatur of the 2015 Definition of Solid Waste
(DSW) final rule. It also includes technical corrections of
typographical errors and missing or incorrect citations found in 40 CFR
part 261.
A. Corrections Related to the 2018 Vacatur of the Definition of Solid
Waste Rule
On July 7, 2017, and March 6, 2018,\12\ the United States Court of
Appeals for the District of Columbia Circuit issued opinions on the
2015 DSW final rule \13\ that, among other things,\14\ (1) vacated the
2015 verified recycler exclusion for hazardous waste that is recycled
off site (except for certain provisions); (2) reinstated the 2008
transfer-based exclusion to replace the now-vacated 2015 verified
recycler exclusion; and (3) upheld the 2015 containment and emergency
preparedness provisions and the eligibility of spent petroleum
catalysts and applied these to the reinstated transfer-based exclusion.
As a result, the EPA issued the 2018 DSW final rule that implemented
the court's decision on May 23, 2018. See 83 FR 24664.
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\12\ American Petroleum Institute v. Environmental Protection
Agency, 862 F.3d 50 (D.C. Cir. 2017), decision modified on
rehearing, 883 F.3d 918 (D.C. Cir. 2018).
\13\ See 80 FR 1694, January 13, 2015.
\14\ The court also vacated factor four of the 2015 definition
of legitimate recycling found at 40 CFR 260.43 and reinstated the
2008 version of factor four to replace the now-vacated 2015 version
of factor four.
---------------------------------------------------------------------------
However, several references to the vacated provisions remained in
40 CFR part 261 subpart M--Emergency Preparedness and Response for
Management of Excluded Hazardous Secondary Materials. In this rule, the
EPA is correcting that error by removing all references to Sec.
260.31(d) (vacated provision). Provisions affected are Sec. Sec.
261.400(a), (b); 261.410(e), (f)(1) and (2); 261.411 introductory text,
(b), (c), and (d)(3); and 261.420 introductory text, (a)(1), and
(b)(2).
In addition, the 2018 vacatur response reinstated the export
provisions for the transfer-based exclusion, found at Sec.
261.4(a)(25). However, those reinstated provisions did not reflect the
revisions the EPA had made to RCRA export requirements in the interim.
In 2016, the EPA finalized changes to existing regulations regarding
the export and import of hazardous wastes and other RCRA regulated
materials from and into the United States (81 FR 85696, November 28,
2016). The final rule established: (1) Improved export and import
shipment tracking; (2) one consolidated and streamlined set of
requirements applying to all imports and exports; (3) mandatory
electronic reporting to the EPA; and (4) a link between the consent to
export and the electronic export information submitted to U.S. Customs
and Border Protection.
However, these changes did not apply to hazardous secondary
material recycled under the exclusion at Sec. 261.4(a)(24) and (25),
because the EPA had removed the export provisions in the 2015 DSW final
rule. When the export provisions were reinstated in 2018 in response to
the court vacatur, they did not reflect the improvements made to all
the other RCRA export-import provisions. This rule updates the
hazardous secondary material export requirements in Sec. 261.4(a)(25)
to be consistent with other RCRA export requirements.
B. Correction of Typographical Errors and Missing or Incorrect
References
The EPA is also correcting a number of typographical errors and
missing or incorrect references found in 40 CFR part 261 to:
<bullet> Add containment buildings (subpart DD of 40 CFR parts 264
and 265) to the list of management methods applicable to recyclable
materials in Sec. 261.6(c)(1).
[[Page 54098]]
<bullet> Change cited regulations from Sec. 265.5113(d)
(incorrect) to Sec. 265.113(d) (correct). See Sec. 261.142(a)(3) and
(4).
<bullet> Change cited regulations from Sec. 265.143(i) (incorrect)
to Sec. 261.143(i) (correct) See Sec. 261.143(a)(7).
<bullet> Change cited regulations from Sec. 264.151(g)(2)
(incorrect) to Sec. 261.151(g)(2) (correct). See Sec.
261.147(g)(2)(i)(B).
<bullet> Change cited regulations from Sec. 261.151(h)(2)
(incorrect) to Sec. 261.151(g)(2) (correct). See Sec.
261.147(g)(2)(ii)(B).
<bullet> Correct numbering at Sec. 261.151(g)(2). Remove the
number for current paragraph 10 of the required agreement language
under ``RECITALS.'' Correct the reference to paragraph 10 in paragraph
8 to read paragraph 9. Renumber the subsequent paragraphs of the
required agreement language under ``RECITALS.''
<bullet> Correct truncated text at Sec. 261.151(l)(2). Consistent
with the corresponding provision in Sec. 264.151(m)(2), the final
sentence is corrected to read: ``State requirements may differ on the
proper content of this acknowledgement.''
<bullet> Change cited regulation from Sec. 262.410(f) (incorrect)
to Sec. 261.410(f) (correct). See Sec. 261.420(b)(3).
<bullet> Revise ``subpart X of this part'' (incorrect) to ``subpart
X of part 264'' (correct). See Sec. 261.1033(n)(1)(i).
<bullet> Change cited regulations from Sec. 261.1082(c)(1)
(incorrect) to Sec. 261.1082(c) (correct). See Sec. 261.1083(a)(1),
(a)(1)(i); and Sec. 261.1084(j)(2)(i).
<bullet> Change cited regulations from Sec. 261.1085(b)(1)(i)
(incorrect) to Sec. 261.1084(b)(1)(i) (correct). See Sec.
261.1083(c)(4).
<bullet> Change cited regulations from Sec. 261.1082(c)(2)
(incorrect) to Sec. 264.1082(c)(2) (correct). See Sec.
261.1084(j)(2)(ii).
<bullet> Change cited regulations from Sec. 261.1082(c)(4)
(incorrect) to Sec. 264.1082(c)(4) (correct). See Sec.
261.1084(j)(2)(iii).
<bullet> Change cited regulations from Sec. 261.1080(b)(7) or (d)
(incorrect) to Sec. 261.1080(a) (correct). See Sec. 261.1089(a).
<bullet> Change cited regulations from Sec. 261.1082(c)(1) or
(c)(2)(i) through (vi) (incorrect) to Sec. 261.1082(c) (correct). See
Sec. 261.1089(f).
<bullet> Remove incorrect reference to Sec. 261.1085(g) (does not
exist). See Sec. 261.1089(g).
VIII. 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 direct final rule finalizes technical corrections to a number
of the regulations in 40 CFR parts 260, 261, 262, 264, 265, 266, 270,
271, and 441 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
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. 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 direct final rule in all States
unless the State is not authorized for the underlying provisions.
Moreover, authorized States are required to modify their programs only
when the EPA promulgates Federal regulations that are more stringent or
broader in scope than the authorized State regulations. For those
changes that are less stringent or reduce the scope of the Federal
program, States are not required to modify their program. This is a
result of section 3009 of RCRA, which allows States to impose more
stringent regulations than the Federal program. This direct final rule
is considered to be neither more nor less stringent than the current
standards. Therefore, authorized States would not be required to modify
their programs to adopt the technical corrections promulgated in this
direct 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.
Although this rule makes a correction to Table 1 in Sec. 271.1
which lists the provisions that have been promulgated under HSWA
authority, the correction to the table is not itself being promulgated
under HSWA.
IX. Statutory and Executive Order Reviews
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
[[Page 54099]]
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. In
making this determination, EPA concludes that the impact of concern for
this rule is any significant adverse economic impact on small entities
and that the agency is certifying that this rule will not have a
significant economic impact on a substantial number of small entities
because the rule relieves regulatory burden, has no net burden or
otherwise has a positive economic effect on the small entities subject
to the rule. 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 net regulatory burden
for all directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate 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
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color) and low-income
populations.
The EPA believes that these technical corrections do not directly
impact 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).
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
List of Subjects
40 CFR Part 260
Environmental protection, Administrative practice and procedure,
Air pollution control, Confidential business information, Hazardous
waste, Intergovernmental relations, Licensing and registration,
Reporting and recordkeeping requirements.
40 CFR Part 261
Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.
40 CFR Part 262
Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.
40 CFR Part 264
Environmental protection, Air pollution control, Hazardous waste,
Insurance, Packaging and containers, Reporting and recordkeeping
requirements, Security measures, Surety bonds.
40 CFR Part 265
Environmental protection, Air pollution control, Hazardous waste,
Insurance, Packaging and containers, Reporting and recordkeeping
requirements, Security measures, Surety bonds, Water supply.
40 CFR Part 266
Environmental protection, Energy, Hazardous waste, Recycling,
Reporting and recordkeeping requirements.
40 CFR Part 270
Environmental Protection, Administrative practice and procedure,
Confidential business information, Hazardous materials transportation,
Hazardous waste, Reporting and recordkeeping requirements, Water
pollution control, Water supply.
40 CFR Part 271
Environmental Protection, Administrative practice and procedure,
Confidential business information, Hazardous materials transportation,
Hazardous waste, Indians--lands, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Water pollution
control, Water supply.
[[Page 54100]]
40 CFR Part 441
Environmental Protection, Health facilities, Mercury, Waste
treatment and disposal, Water pollution control.
Michael S. Regan,
Administrator.
For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:
PART 260--HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL
0
1. The authority for part 260 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6934,
6935, 6937, 6938, 6939, 6939g, and 6974.
Sec. 260.10 [Amended]
0
2. Section 260.10 is amended in the definition of ``Final closure'' by
removing ``Sec. 262.34'' and adding ``Sec. Sec. 262.16 and 262.17''
in its place.
PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
0
3. 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
4. Section 261.1 is amended by revising paragraph (a)(1) to read as
follows:
Sec. 261.1 Purpose and scope.
(a) * * *
(1) Subpart A defines the terms ``solid waste'' and ``hazardous
waste'', identifies those wastes which are excluded from regulation
under parts 262 through 266, 268, and 270 of this subchapter and
establishes special management requirements for hazardous waste which
is recycled.
* * * * *
0
5. Section 261.4 is amended by revising paragraphs (a)(25)(i)(I),
(a)(25)(vi) and (vii), (a)(25)(xi)(D), and (e)(1) introductory text to
read as follows:
Sec. 261.4 Exclusions.
(a) * * *
(25) * * *
(i) * * *
(I) The name of any countries of transit through which the
hazardous secondary material will be sent and a description of the
approximate length of time it will remain in such countries and the
nature of its handling while there (for purposes of this section, the
terms ``EPA Acknowledgment of Consent'', ``country of import'' and
``country of transit'' are used as defined in 40 CFR 262.81 with the
exception that the terms in this section refer to hazardous secondary
materials, rather than hazardous waste):
* * * * *
(vi) The export of hazardous secondary material under this
paragraph (a)(25) is prohibited unless the hazardous secondary material
generator receives from EPA an EPA Acknowledgment of Consent
documenting the consent of the country of import to the receipt of the
hazardous secondary material. Where the country of import objects to
receipt of the hazardous secondary material or withdraws a prior
consent, EPA will notify the hazardous secondary material generator in
writing. EPA will also notify the hazardous secondary material
generator of any responses from countries of transit.
(vii) Prior to each shipment, the hazardous secondary material
generator or a U.S. authorized agent must:
(A) Submit Electronic Export Information (EEI) for each shipment to
the Automated Export System (AES) or its successor system, under the
International Trade Data System (ITDS) platform, in accordance with 15
CFR 30.4(b).
(B) Include the following items in the EEI, along with the other
information required under 15 CFR 30.6:
(1) EPA license code;
(2) Commodity classification code per 15 CFR 30.6(a)(12);
(3) EPA consent number;
(4) Country of ultimate destination per 15 CFR 30.6(a)(5);
(5) Date of export per 15 CFR 30.6(a)(2);
(6) Quantity of waste in shipment and units for reported quantity,
if required reporting units established by value for the reported
commodity classification number are in units of weight or volume per 15
CFR 30.6(a)(15); or
(7) EPA net quantity reported in units of kilograms, if required
reporting units established by value for the reported commodity
classification number are not in units of weight or volume.
* * * * *
(xi) * * *
(D) By reclaimer and intermediate facility, for each hazardous
secondary material exported, a description of the hazardous secondary
material and the EPA hazardous waste number that would apply if the
hazardous secondary material was managed as hazardous waste, the DOT
hazard class, the name and U.S. EPA ID number (where applicable) for
each transporter used, the consent number(s) under which the hazardous
secondary material was shipped and for each consent number, the total
amount of hazardous secondary material shipped and the number of
shipments exported during the calendar year covered by the report;
* * * * *
(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 and 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 262.16(b)(1) when:
* * * * *
0
6. Section 261.6 is amended by revising paragraph (c)(1) to read as
follows:
Sec. 261.6 Requirements for recyclable materials.
* * * * *
(c)(1) Owners and operators of facilities that store recyclable
materials before they are recycled are regulated under all applicable
provisions of subparts A though L and AA through DD of 40 CFR parts 264
and 265, and under 40 CFR parts 124, 266, 267, 268, and 270 and the
notification requirements under section 3010 of RCRA, except as
provided in paragraph (a) of this section. (The recycling process
itself is exempt from regulation except as provided in paragraph (d) of
this section.)
* * * * *
Sec. 261.11 [Amended]
0
7. Section 261.11 is amended by removing paragraph (c).
0
8. Section 261.30 is amended by revising paragraph (d) to read as
follows:
Sec. 261.30 General.
* * * * *
(d) The following hazardous wastes listed in Sec. 261.31 are
subject to the generator category limits for acutely hazardous wastes
established in table 1 of Sec. 262.13 of this subchapter: EPA
Hazardous Wastes Nos. F020, F021, F022, F023, F026 and F027.
0
9. Section 261.142 is amended by revising paragraphs (a)(2) through (4)
to read as follows:
Sec. 261.142 Cost estimate.
(a) * * *
[[Page 54101]]
(2) The cost estimate must be based on the costs to the owner or
operator of hiring a third party to conduct these activities. A third
party is a party who is neither a parent nor a subsidiary of the owner
or operator. (See definition of ``parent corporation'' in Sec.
265.141(d) of this subchapter.) The owner or operator may use costs for
on-site disposal in accordance with applicable requirements if he can
demonstrate that on-site disposal capacity will exist at all times over
the life of the facility.
(3) The cost estimate may not incorporate any salvage value that
may be realized with the sale of hazardous secondary materials, or
hazardous or non-hazardous wastes if applicable under Sec. 265.113(d)
of this subchapter, facility structures or equipment, land, or other
assets associated with the facility.
(4) The owner or operator may not incorporate a zero cost for
hazardous secondary materials, or hazardous or non-hazardous wastes if
applicable under Sec. 265.113(d) of this subchapter that might have
economic value.
* * * * *
0
10. Section 261.143 is amended by revising paragraph (a)(7) to read as
follows:
Sec. 261.143 Financial assurance condition.
* * * * *
(a) * * *
(7) Within 60 days after receiving a request from the owner or
operator for release of funds as specified in paragraph (a)(5) or (6)
of this section, the Regional Administrator will instruct the trustee
to release to the owner or operator such funds as the Regional
Administrator specifies in writing. If the owner or operator begins
final closure under subpart G of 40 CFR part 264 or 265, an owner or
operator may request reimbursements for partial or final closure
expenditures by submitting itemized bills to the Regional
Administrator. The owner or operator may request reimbursements for
partial closure only if sufficient funds are remaining in the trust
fund to cover the maximum costs of closing the facility over its
remaining operating life. No later than 60 days after receiving bills
for partial or final closure activities, the Regional Administrator
will instruct the trustee to make reimbursements in those amounts as
the Regional Administrator specifies in writing, if the Regional
Administrator determines that the partial or final closure expenditures
are in accordance with the approved closure plan, or otherwise
justified. If the Regional Administrator has reason to believe that the
maximum cost of closure over the remaining life of the facility will be
significantly greater than the value of the trust fund, he may withhold
reimbursements of such amounts as he deems prudent until he determines,
in accordance with paragraph (i) of this section that the owner or
operator is no longer required to maintain financial assurance for
final closure of the facility. If the Regional Administrator does not
instruct the trustee to make such reimbursements, he will provide to
the owner or operator a detailed written statement of reasons.
* * * * *
0
11. Section 261.147 is amended by revising paragraphs (g)(2)(i)(B) and
(g)(2)(ii)(B) to read as follows:
Sec. 261.147 Liability requirements.
* * * * *
(g) * * *
(2)(i) * * *
(B) Each State in which a facility covered by the guarantee is
located have submitted a written statement to EPA that a guarantee
executed as described in this section and Sec. 261.151(g)(2) is a
legally valid and enforceable obligation in that State.
(ii) * * *
(B) The Attorney General or Insurance Commissioner of each State in
which a facility covered by the guarantee is located and the State in
which the guarantor corporation has its principal place of business,
has submitted a written statement to EPA that a guarantee executed as
described in this section and Sec. 261.151(g)(2) is a legally valid
and enforceable obligation in that State.
* * * * *
0
12. Section 261.151 is amended by revising paragraphs (g)(2) and (l)(2)
to read as follows:
Sec. 261.151 Wording of the instruments.
* * * * *
(g) * * *
(2) A guarantee, as specified in Sec. 261.147(g), must be worded
as follows, except that instructions in brackets are to be replaced
with the relevant information and the brackets deleted:
Guarantee for Liability Coverage
Guarantee made this [date] by [name of guaranteeing entity], a
business corporation organized under the laws of [if incorporated
within the United States insert ``the State of ___-'' and insert
name of State; if incorporated outside the United States insert the
name of the country in which incorporated, the principal place of
business within the United States, and the name and address of the
registered agent in the State of the principal place of business],
herein referred to as guarantor. This guarantee is made on behalf of
[owner or operator] of [business address], which is one of the
following: ``our subsidiary;'' ``a subsidiary of [name and address
of common parent corporation], of which guarantor is a subsidiary;''
or ``an entity with which guarantor has a substantial business
relationship, as defined in 40 CFR [either 264.141(h) or
265.141(h)]'', to any and all third parties who have sustained or
may sustain bodily injury or property damage caused by [sudden and/
or nonsudden] accidental occurrences arising from operation of the
facility(ies) covered by this guarantee.
Recitals
1. Guarantor meets or exceeds the financial test criteria and
agrees to comply with the reporting requirements for guarantors as
specified in 40 CFR 261.147(g).
2. [Owner or operator] owns or operates the following
facility(ies) covered by this guarantee: [List for each facility:
EPA identification number (if any issued), name, and address; and if
guarantor is incorporated outside the United States list the name
and address of the guarantor's registered agent in each State.] This
corporate guarantee satisfies RCRA third-party liability
requirements for [insert ``sudden'' or ``nonsudden'' or ``both
sudden and nonsudden''] accidental occurrences in above-named owner
or operator facilities for coverage in the amount of [insert dollar
amount] for each occurrence and [insert dollar amount] annual
aggregate.
3. For value received from [owner or operator], guarantor
guarantees to any and all third parties who have sustained or may
sustain bodily injury or property damage caused by [sudden and/or
nonsudden] accidental occurrences arising from operations of the
facility(ies) covered by this guarantee that in the event that
[owner or operator] fails to satisfy a judgment or award based on a
determination of liability for bodily injury or property damage to
third parties caused by [sudden and/or nonsudden] accidental
occurrences, arising from the operation of the above-named
facilities, or fails to pay an amount agreed to in settlement of a
claim arising from or alleged to arise from such injury or damage,
the guarantor will satisfy such judgment(s), award(s) or settlement
agreement(s) up to the limits of coverage identified above.
4. Such obligation does not apply to any of the following:
(a) Bodily injury or property damage for which [insert owner or
operator] is obligated to pay damages by reason of the assumption of
liability in a contract or agreement. This exclusion does not apply
to liability for damages that [insert owner or operator] would be
obligated to pay in the absence of the contract or agreement.
(b) Any obligation of [insert owner or operator] under a
workers' compensation, disability benefits, or unemployment
compensation law or any similar law.
(c) Bodily injury to:
(1) An employee of [insert owner or operator] arising from, and
in the course of, employment by [insert owner or operator]; or
(2) The spouse, child, parent, brother, or sister of that
employee as a consequence of, or arising from, and in the course of
employment by [insert owner or operator]. This exclusion applies:
[[Page 54102]]
(A) Whether [insert owner or operator] may be liable as an
employer or in any other capacity; and
(B) To any obligation to share damages with or repay another
person who must pay damages because of the injury to persons
identified in paragraphs (1) and (2).
(d) Bodily injury or property damage arising out of the
ownership, maintenance, use, or entrustment to others of any
aircraft, motor vehicle or watercraft.
(e) Property damage to:
(1) Any property owned, rented, or occupied by [insert owner or
operator];
(2) Premises that are sold, given away or abandoned by [insert
owner or operator] if the property damage arises out of any part of
those premises;
(3) Property loaned to [insert owner or operator];
(4) Personal property in the care, custody or control of [insert
owner or operator];
(5) That particular part of real property on which [insert owner
or operator] or any contractors or subcontractors working directly
or indirectly on behalf of [insert owner or operator] are performing
operations, if the property damage arises out of these operations.
5. Guarantor agrees that if, at the end of any fiscal year
before termination of this guarantee, the guarantor fails to meet
the financial test criteria, guarantor shall send within 90 days, by
certified mail, notice to the EPA Regional Administrator[s] for the
Region[s] in which the facility[ies] is[are] located and to [owner
or operator] that he intends to provide alternate liability coverage
as specified in 40 CFR 261.147, as applicable, in the name of [owner
or operator]. Within 120 days after the end of such fiscal year, the
guarantor shall establish such liability coverage unless [owner or
operator] has done so.
6. The guarantor agrees to notify the EPA Regional Administrator
by certified mail of a voluntary or involuntary proceeding under
title 11 (Bankruptcy), U.S. Code, naming guarantor as debtor, within
10 days after commencement of the proceeding. Guarantor agrees that
within 30 days after being notified by an EPA Regional Administrator
of a determination that guarantor no longer meets the financial test
criteria or that he is disallowed from continuing as a guarantor, he
shall establish alternate liability coverage as specified in 40 CFR
261.147 in the name of [owner or operator], unless [owner or
operator] has done so.
7. Guarantor reserves the right to modify this agreement to take
into account amendment or modification of the liability requirements
set by 40 CFR 261.147, provided that such modification shall become
effective only if a Regional Administrator does not disapprove the
modification within 30 days of receipt of notification of the
modification.
8. Guarantor agrees to remain bound under this guarantee for so
long as [owner or operator] must comply with the applicable
requirements of 40 CFR 261.147 for the above-listed facility(ies),
except as provided in paragraph 9 of this agreement.
9. [Insert the following language if the guarantor is (a) a
direct or higher-tier corporate parent, or (b) a firm whose parent
corporation is also the parent corporation of the owner or
operator]:
Guarantor may terminate this guarantee by sending notice by
certified mail to the EPA Regional Administrator(s) for the
Region(s) in which the facility(ies) is(are) located and to [owner
or operator], provided that this guarantee may not be terminated
unless and until [the owner or operator] obtains, and the EPA
Regional Administrator(s) approve(s), alternate liability coverage
complying with 40 CFR 261.147.
[Insert the following language if the guarantor is a firm
qualifying as a guarantor due to its ``substantial business
relationship'' with the owner or operator]:
Guarantor may terminate this guarantee 120 days following
receipt of notification, through certified mail, by the EPA Regional
Administrator(s) for the Region(s) in which the facility(ies)
is(are) located and by [the owner or operator].
10. Guarantor hereby expressly waives notice of acceptance of
this guarantee by any party.
11. Guarantor agrees that this guarantee is in addition to and
does not affect any other responsibility or liability of the
guarantor with respect to the covered facilities.
12. The Guarantor shall satisfy a third-party liability claim
only on receipt of one of the following documents:
(a) Certification from the Principal and the third-party
claimant(s) that the liability claim should be paid. The
certification must be worded as follows, except that instructions in
brackets are to be replaced with the relevant information and the
brackets deleted:
Certification of Valid Claim
The undersigned, as parties [insert Principal] and [insert name
and address of third-party claimant(s)], hereby certify that the
claim of bodily injury and/or property damage caused by a [sudden or
nonsudden] accidental occurrence arising from operating
[Principal's] facility should be paid in the amount of $.
[Signatures]
Principal
(Notary) Date
[Signatures]
Claimant(s)
(Notary) Date
(b) A valid final court order establishing a judgment against
the Principal for bodily injury or property damage caused by sudden
or nonsudden accidental occurrences arising from the operation of
the Principal's facility or group of facilities.
13. In the event of combination of this guarantee with another
mechanism to meet liability requirements, this guarantee will be
considered [insert ``primary'' or ``excess''] coverage.
I hereby certify that the wording of the guarantee is identical
to the wording specified in 40 CFR 261.151(g)(2) as such regulations
were constituted on the date shown immediately below.
Effective date:
[Name of guarantor]
[Authorized signature for guarantor]
[Name of person signing]
[Title of person signing]
Signature of witness or notary:
* * * * *
(l) * * *
(2) The following is an example of the certification of
acknowledgement which must accompany the trust agreement for a trust
fund as specified in Sec. 261.147(j). State requirements may differ on
the proper content of this acknowledgement.
State of
County of
On this [date], before me personally came [owner or operator] to me
known, who, being by me duly sworn, did depose and say that she/he
resides at [address], that she/he is [title] of [corporation], the
corporation described in and which executed the above instrument;
that she/he knows the seal of said corporation; that the seal
affixed to such instrument is such corporate seal; that it was so
affixed by order of the Board of Directors of said corporation, and
that she/he signed her/his name thereto by like order.
[Signature of Notary Public]
* * * * *
0
13. Section 261.400 is amended by revising paragraphs (a) and (b) to
read as follows:
Sec. 261.4009 Applicability.
* * * * *
(a) A generator of hazardous secondary material, or an intermediate
or reclamation facility, that accumulates 6000 kg or less of hazardous
secondary material at any time must comply with Sec. Sec. 261.410 and
261.411.
(b) A generator of hazardous secondary material, or an intermediate
or reclamation facility that accumulates more than 6000 kg of hazardous
secondary material at any time must comply with Sec. Sec. 261.410 and
261.420.
0
14. Section 261.410 is amended by revising paragraphs (e), (f)(1)
introductory text, and (f)(2) to read as follows:
Sec. 261.410 Preparedness and prevention.
* * * * *
(e) Required aisle space. The hazardous secondary material
generator or intermediate or reclamation facility must maintain aisle
space to allow the unobstructed movement of personnel, fire protection
equipment, spill control equipment, and decontamination equipment to
any area of facility operation in an emergency, unless aisle space is
not needed for any of these purposes.
(f) * * *
(1) The hazardous secondary material generator or an intermediate
or reclamation facility must attempt to make the following
arrangements, as appropriate for the type of waste handled at his
facility and the potential
[[Page 54103]]
need for the services of these organizations:
* * * * *
(2) Where State or local authorities decline to enter into such
arrangements, the hazardous secondary material generator or an
intermediate or reclamation facility must document the refusal in the
operating record.
0
15. Section 261.411 is amended by revising the introductory text and
paragraphs (b) introductory text, (c), and (d)(3) introductory text to
read as follows:
Sec. 261.411 Emergency procedures for facilities generating or
accumulating 6000 kg or less of hazardous secondary material.
A generator or an intermediate or reclamation facility that
generates or accumulates 6000 kg or less of hazardous secondary
material must comply with the following requirements:
* * * * *
(b) The generator or intermediate or reclamation facility must post
the following information next to the telephone:
* * * * *
(c) The generator or an intermediate or reclamation facility must
ensure that all employees are thoroughly familiar with proper waste
handling and emergency procedures, relevant to their responsibilities
during normal facility operations and emergencies;
(d) * * *
(3) In the event of a fire, explosion, or other release which could
threaten human health outside the facility or when the generator or an
intermediate or reclamation facility has knowledge that a spill has
reached surface water, the generator or an intermediate or reclamation
facility operating under a verified recycler variance under Sec.
260.31(d) of this subchapter must immediately notify the National
Response Center (using their 24-hour toll free number 800/424-8802).
The report must include the following information:
* * * * *
0
16. Section 261.420 is amended by revising the introductory text and
paragraphs (a)(1) and (b)(2) and (3) to read as follows:
Sec. 261.420 Contingency planning and emergency procedures for
facilities generating or accumulating more than 6000 kg of hazardous
secondary material.
A generator or an intermediate or reclamation facility that
generates or accumulates more than 6000 kg of hazardous secondary
material must comply with the following requirements:
(a) * * *
(1) Each generator or an intermediate or reclamation facility that
accumulates more than 6000 kg of hazardous secondary material must have
a contingency plan for his facility. The contingency plan must be
designed to minimize hazards to human health or the environment from
fires, explosions, or any unplanned sudden or non-sudden release of
hazardous secondary material or hazardous secondary material
constituents to air, soil, or surface water.
* * * * *
(b) * * *
(2) If the generator or an intermediate or reclamation facility
accumulating more than 6000 kg of hazardous secondary material has
already prepared a Spill Prevention, Control, and Countermeasures
(SPCC) Plan in accordance with part 112 of this chapter, or some other
emergency or contingency plan, he need only amend that plan to
incorporate hazardous waste management provisions that are sufficient
to comply with the requirements of this part. The hazardous secondary
material generator or an intermediate or reclamation facility operating
under a verified recycler variance under Sec. 260.31(d) of this
subchapter may develop one contingency plan which meets all regulatory
requirements. EPA recommends that the plan be based on the National
Response Team's Integrated Contingency Plan Guidance (``One Plan'').
When modifications are made to non-RCRA provisions in an integrated
contingency plan, the changes do not trigger the need for a RCRA permit
modification.
(3) The plan must describe arrangements agreed to by local police
departments, fire departments, hospitals, contractors, and State and
local emergency response teams to coordinate emergency services,
pursuant to Sec. 261.410(f).
* * * * *
0
17. Section 261.1033 is amended by revising paragraph (n)(1)(i) as
follows:
Sec. 261.1033 Standards: Closed-vent systems and control devices.
* * * * *
(n) * * *
(1) * * *
(i) The owner or operator of the unit has been issued a final
permit under 40 CFR part 270 which implements the requirements of 40
CFR part 264, subpart X; or
* * * * *
0
18. Section 261.1083 is amended by revising paragraphs (a)(1)
introductory text, (a)(1)(i), and (c)(4) to read as follows:
Sec. 261.1083 Material determination procedures.
(a) * * *
(1) Determining average VO concentration at the point of material
origination. A remanufacturer or other person that stores or treats the
hazardous secondary material shall determine the average VO
concentration at the point of material origination for each hazardous
secondary material placed in a hazardous secondary material management
unit exempted under the provisions of Sec. 261.1082(c) from using air
emission controls in accordance with standards specified in Sec. Sec.
261.1084 through 261.1087, as applicable to the hazardous secondary
material management unit.
(i) An initial determination of the average VO concentration of the
material stream shall be made before the first time any portion of the
material in the hazardous secondary material stream is placed in a
hazardous secondary material management unit exempted under the
provisions of Sec. 261.1082(c) from using air emission controls, and
thereafter an initial determination of the average VO concentration of
the material stream shall be made for each averaging period that a
hazardous secondary material is managed in the unit; and
* * * * *
(c) * * *
(4) Use of knowledge to determine the maximum organic vapor
pressure of the hazardous secondary material. Documentation shall be
prepared and recorded that presents the information used as the basis
for the knowledge by the remanufacturer or other person that stores or
treats the hazardous secondary material that the maximum organic vapor
pressure of the hazardous secondary material is less than the maximum
vapor pressure limit listed in Sec. 261.1084(b)(1)(i) for the
applicable tank design capacity category. An example of information
that may be used is documentation that the hazardous secondary material
is generated by a process for which at other locations it previously
has been determined by direct measurement that the hazardous secondary
material's waste maximum organic vapor pressure is less than the
maximum vapor pressure limit for the appropriate tank design capacity
category.
* * * * *
0
19. Section 261.1084 is amended by revising paragraphs (j)(2)(i)
through (iii) to read as follows:
[[Page 54104]]
Sec. 261.1084 Standards: tanks.
* * * * *
(j) * * *
(2) * * *
(i) The hazardous secondary material meets the average VO
concentration conditions specified in Sec. 261.1082(c) at the point of
material origination.
(ii) The hazardous secondary material has been treated by an
organic destruction or removal process to meet the requirements in
Sec. 264.1082(c)(2).
(iii) The hazardous secondary material meets the requirements of
Sec. 264.1082(c)(4).
* * * * *
0
20. Section 261.1089 is amended by revising paragraphs (a), (f), and
(g) to read as follows:
Sec. 261.1089 Recordkeeping requirements.
(a) Each remanufacturer or other person that stores or treats the
hazardous secondary material subject to requirements of this subpart
shall record and maintain the information specified in paragraphs (b)
through (j) of this section, as applicable to the facility. Except for
air emission control equipment design documentation and information
required by paragraphs (i) and (j) of this section, records required by
this section shall be maintained at the facility for a minimum of 3
years. Air emission control equipment design documentation shall be
maintained at the facility until the air emission control equipment is
replaced or otherwise no longer in service. Information required by
paragraphs (i) and (j) of this section shall be maintained at the
facility for as long as the hazardous secondary material management
unit is not using air emission controls specified in Sec. Sec.
261.1084 through 261.1087 in accordance with the conditions specified
in Sec. 261.1080(a).
* * * * *
(f) The remanufacturer or other person that stores or treats the
hazardous secondary material using a tank or container exempted under
the hazardous secondary material organic concentration conditions
specified in Sec. 261.1082(c), shall prepare and maintain at the
facility records documenting the information used for each material
determination (e.g., test results, measurements, calculations, and
other documentation). If analysis results for material samples are used
for the material determination, then the remanufacturer or other person
that stores or treats the hazardous secondary material shall record the
date, time, and location that each material sample is collected in
accordance with applicable requirements of Sec. 261.1083.
(g) A remanufacturer or other person that stores or treats the
hazardous secondary material designating a cover as ``unsafe to inspect
and monitor'' pursuant to Sec. 261.1084(l) shall record and keep at
facility the following information: The identification numbers for
hazardous secondary material management units with covers that are
designated as ``unsafe to inspect and monitor,'' the explanation for
each cover stating why the cover is unsafe to inspect and monitor, and
the plan and schedule for inspecting and monitoring each cover.
* * * * *
0
21. Amend appendix IX to part 261 by revising the entries for ``Bekaert
Corp'' and ``Saturn Corporation'' in table 1 and by revising the entry
for ``American Chrome & Chemical'' in table 2 to read as follows:
Appendix IX to Part 261--Wastes Excluded Under Sec. Sec. 260.20 and
260.22
Table 1--Wastes Excluded From Non-Specific Sources
------------------------------------------------------------------------
Facility Address Waste description
------------------------------------------------------------------------
* * * * * * *
Bekaert Corp................ Dyersburg, TN.. Dewatered wastewater
treatment plant (WWTP)
sludge (EPA Hazardous
Waste Nos. F006)
generated at a maximum
rate of 1250 cubic yards
per calendar year after
May 27, 2004, and
disposed in a Subtitle D
landfill.
For the exclusion to be
valid, Bekaert must
implement a verification
testing program that
meets the following
paragraphs:
(1) Delisting Levels: All
leachable concentrations
for those constituents
must not exceed the
maximum allowable
concentrations in mg/l
specified in this
paragraph. Bekaert must
use the leaching method
specified at Sec.
261.24 to measure
constituents in the
waste leachate.
(A) Inorganic
Constituents TCLP (mg/
l): Cadmium--0.672;
Chromium--5.0; Nickel--
127; Zinc--1260.0.
(B) Organic Constituents
TCLP (mg/l): Methyl
ethyl ketone--200.0.
(2) Waste Holding and
Handling:
(A) Bekaert must
accumulate the hazardous
waste dewatered WWTP
sludge in accordance
with the applicable
regulations of Sec.
Sec. 262.15, 262.16,
and 262.17 of this
subchapter, as
applicable, and continue
to dispose of the
dewatered WWTP sludge as
hazardous waste.
(B) Once the first
quarterly sampling and
analyses event described
in paragraph (3) is
completed and valid
analyses demonstrate
that no constituent is
present in the sample at
a level which exceeds
the delisting levels set
in paragraph (1),
Bekaert can manage and
dispose of the dewatered
WWTP sludge as
nonhazardous according
to all applicable solid
waste regulations.
(C) If constituent levels
in any sample taken by
Bekaert exceed any of
the delisting levels set
in paragraph (1),
Bekaert must do the
following: (i) notify
EPA in accordance with
paragraph (7) and (ii)
manage and dispose the
dewatered WWTP sludge as
hazardous waste
generated under Subtitle
C of RCRA.
(D) Quarterly
Verification Testing
Requirements: Upon this
exclusion becoming
final, Bekaert may begin
the quarterly testing
requirements of
paragraph (3) on its
dewatered WWTP sludge.
(3) Quarterly Testing
Requirements: Upon this
exclusion becoming
final, Bekaert may
perform quarterly
analytical testing by
sampling and analyzing
the dewatered WWTP
sludge as follows:
(A)(i) Collect four
representative composite
samples of the hazardous
waste dewatered WWTP
sludge at quarterly
(ninety (90) day)
intervals after EPA
grants the final
exclusion. The first
composite sample may be
taken at any time after
EPA grants the final
approval.
(ii) Analyze the samples
for all constituents
listed in paragraph (1).
Any roll-offs from which
the composite sample is
taken exceeding the
delisting levels listed
in paragraph (1) must be
disposed as hazardous
waste in a Subtitle C
landfill.
(iii) Within forty-five
(45) days after taking
its first quarterly
sample, Bekaert will
report its first
quarterly analytical
test data to EPA. If
levels of constituents
measured in the sample
of the dewatered WWTP
sludge do not exceed the
levels set forth in
paragraph (1) of this
exclusion, Bekaert can
manage and dispose the
nonhazardous dewatered
WWTP sludge according to
all applicable solid
waste regulations.
(4) Annual Testing:
(A) If Bekaert completes
the quarterly testing
specified in paragraph
(3) above and no sample
contains a constituent
with a level which
exceeds the limits set
forth in paragraph (1),
Bekaert may begin annual
testing as follows:
Bekaert must test one
representative composite
sample of the dewatered
WWTP sludge for all
constituents listed in
paragraph (1) at least
once per calendar year.
[[Page 54105]]
(B) The sample for the
annual testing shall be
a representative
composite sample for all
constituents listed in
paragraph (1).
(C) The sample for the
annual testing taken for
the second and
subsequent annual
testing events shall be
taken within the same
calendar month as the
first annual sample
taken.
(5) Changes in Operating
Conditions: If Bekaert
significantly changes
the process described in
its petition or starts
any processes that
generate(s) the waste
that may or could affect
the composition or type
of waste generated as
established under
paragraph (1) (by
illustration, but not
limitation, changes in
equipment or operating
conditions of the
treatment process), it
must notify the EPA in
writing; it may no
longer handle the wastes
generated from the new
process as nonhazardous
until the wastes meet
the delisting levels set
in paragraph (1) and it
has received written
approval to do so from
the EPA.
(6) Data Submittals:
Bekaert must submit the
information described
below. If Bekaert fails
to submit the required
data within the
specified time or
maintain the required
records on-site for the
specified time, the EPA,
at its discretion, will
consider this sufficient
basis to reopen the
exclusion as described
in paragraph (7).
Bekaert must:
(A) Submit the data
obtained through
paragraph (3) to the
Chief, North Section,
RCRA Enforcement and
Compliance Branch, Waste
Division, U. S.
Environmental Protection
Agency Region 4, 61
Forsyth Street, SW.,
Atlanta, Georgia, 30303,
within the time
specified.
(B) Compile records of
analytical data from
paragraph (3),
summarized, and
maintained on-site for a
minimum of five years.
(C) Furnish these records
and data when either the
EPA or the State of
Tennessee request them
for inspection.
(D) Send along with all
data a signed copy of
the following
certification statement,
to attest to the truth
and accuracy of the data
submitted:
``Under civil and
criminal penalty of law
for the making or
submission of false or
fraudulent statements or
representations
(pursuant to the
applicable provisions of
the Federal Code, which
include, but may not be
limited to, 18 U.S.C.
1001 and 42 U.S.C.
6928), I certify that
the information
contained in or
accompanying this
document is true,
accurate and complete.
As to the (those)
identified section(s) of
this document for which
I cannot personally
verify its (their) truth
and accuracy, I certify
as the company official
having supervisory
responsibility for the
persons who, acting
under my direct
instructions, made the
verification that this
information is true,
accurate and complete.
If any of this
information is
determined by the EPA in
its sole discretion to
be false, inaccurate or
incomplete, and upon
conveyance of this fact
to the company, I
recognize and agree that
this exclusion of waste
will be void as if it
never had effect or to
the extent directed by
the EPA and that the
company will be liable
for any actions taken in
contravention of the
company's RCRA and
CERCLA obligations
premised upon the
company's reliance on
the void exclusion.''
(7) Reopener:
(A) If, any time after
disposal of the delisted
waste Bekaert possesses
or is otherwise made
aware of any
environmental data
(including but not
limited to leachate data
or ground water
monitoring data) or any
other data relevant to
the delisted waste
indicating that any
constituent identified
for the delisting
verification testing is
at level higher than the
delisting level allowed
by the Regional
Administrator or his
delegate in granting the
petition, then the
facility must report the
data, in writing, to the
Regional Administrator
or his delegate within
ten (10) days of first
possessing or being made
aware of that data.
(B) If either the
quarterly or annual
testing of the waste
does not meet the
delisting requirements
in paragraph (1),
Bekaert must report the
data, in writing, to the
Regional Administrator
or his delegate within
ten (10) days of first
possessing or being made
aware of that data.
(C) If Bekaert fails to
submit the information
described in paragraphs
(5), (6)(A) or (6)(B) or
if any other information
is received from any
source, the Regional
Administrator or his
delegate will make a
preliminary
determination as to
whether the reported
information requires the
EPA action to protect
human health or the
environment. Further
action may include
suspending, or revoking
the exclusion, or other
appropriate response
necessary to protect
human health and the
environment.
(D) If the Regional
Administrator or his
delegate determines that
the reported information
requires action the EPA,
the Regional
Administrator or his
delegate will notify the
facility in writing of
the actions the Regional
Administrator or his
delegate believes are
necessary to protect
human health and the
environment. The
notification shall
include a statement of
the proposed action and
a statement providing
the facility with an
opportunity to present
information as to why
the proposed the EPA
action is not necessary.
The facility shall have
ten (10) days from the
date of the Regional
Administrator or his
delegate's notice to
present such
information.
(E) Following the receipt
of information from the
facility described in
paragraph (6)(D) or (if
no information is
presented under
paragraph (6)(D)) the
initial receipt of
information described in
paragraphs (5), (6)(A)
or (6)(B), the Regional
Administrator or his
delegate will issue a
final written
determination describing
the EPA actions that are
necessary to protect
human health or the
environment. Any
required action
described in the
Regional Administrator
or his delegate's
determination shall
become effective
immediately, unless the
Regional Administrator
or his delegate provides
otherwise.
(8) Notification
Requirements: Bekaert
must do following before
transporting the
delisted waste:
(A) Provide a one-time
written notification to
any State Regulatory
Agency to which or
through which it will
transport the delisted
waste described above
for disposal, sixty (60)
days before beginning
such activities.
(B) Update the one-time
written notification if
Bekaert ships the
delisted waste into a
different disposal
facility.
(C) Failure to provide
this notification will
result in a violation of
the delisting variance
and a possible
revocation of the
decision.
* * * * * * *
Saturn Corporation.......... Spring Hill, Dewatered wastewater
Tennessee. treatment plant (WWTP)
sludge (EPA Hazardous
Waste No. F019)
generated at a maximum
rate of 3,000 cubic
yards per calendar year.
The sludge must be
disposed in a lined,
Subtitle D landfill with
leachate collection that
is licensed, permitted,
or otherwise authorized
to accept the delisted
WWTP sludge in
accordance with 40 CFR
part 258. The exclusion
becomes effective on
December 23, 2005.
For the exclusion to be
valid, Saturn must
implement a verification
testing program that
meets the following
conditions:
[[Page 54106]]
1. Delisting Levels: The
constituent
concentrations in an
extract of the waste
must not exceed the
following maximum
allowable concentrations
in mg/l: antimony--
0.494; arsenic--0.224;
total chromium--3.71;
lead--5.0; nickel--68;
thallium--0.211; and
zinc--673. Sample
collection and analyses,
including quality
control procedures, must
be performed using
appropriate methods. As
applicable to the method-
defined parameters of
concern, analyses
requiring the use of SW-
846 methods incorporated
by reference in 40 CFR
260.11 must be used
without substitution. As
applicable, the SW-846
methods might include
Methods 0010, 0011,
0020, 0023A, 0030, 0031,
0040, 0050, 0051, 0060,
0061, 1010B, 1020C,
1110A, 1310B, 1311,
1312, 1320, 1330A,
9010C, 9012B, 9040C,
9045D, 9060A, 9070A,
(uses EPA Method 1664,
Rev. A), 9071B, and
9095B. Methods must meet
Performance Based
Measurement System
Criteria in which the
Data Quality Objectives
are to demonstrate that
representative samples
of Saturn's sludge meet
the delisting levels in
this condition.
2. Waste Holding and
Handling:
(a) Saturn must
accumulate the hazardous
waste dewatered WWTP
sludge in accordance
with the applicable
regulations of Sec.
Sec. 262.15, 262.16,
and 262.17 of this
subchapter, and continue
to dispose of the
dewatered WWTP sludge as
hazardous waste until
the results of the first
quarterly verification
testing are available.
(b) After the first
quarterly verification
sampling event described
in Condition (3) has
been completed and the
laboratory data
demonstrates that no
constituent is present
in the sample at a level
which exceeds the
delisting levels set in
Condition (1), Saturn
can manage and dispose
of the dewatered WWTP
sludge as nonhazardous
according to all
applicable solid waste
regulations.
(c) If constituent levels
in any sample taken by
Saturn exceed any of the
delisting levels set in
Condition (1), Saturn
must do the following:
(i) Notify EPA in
accordance with
Condition (7) and
(ii) Manage and dispose
the dewatered WWTP
sludge as hazardous
waste generated under
Subtitle C of RCRA.
3. Quarterly Testing
Requirements: Upon this
exclusion becoming
final, Saturn may
perform quarterly
analytical testing by
sampling and analyzing
the dewatered WWTP
sludge as follows:
(i) Collect one
representative composite
sample (consisting of
four grab samples) of
the hazardous waste
dewatered WWTP sludge at
any time after EPA
grants the final
delisting. In addition,
collect the second,
third, and fourth
quarterly samples at
approximately ninety
(90)-day intervals after
EPA grants the final
exclusion.
(ii) Analyze the samples
for all constituents
listed in Condition (1).
Any roll-offs from which
the composite sample is
taken exceeding the
delisting levels listed
in Condition (1) must be
disposed as hazardous
waste in a Subtitle C
landfill.
(iii) Within forty-five
(45) days after taking
its first quarterly
sample, Saturn will
report its first
quarterly analytical
test data to EPA and
will include the
certification statement
required in condition
(6). If levels of
constituents measured in
the sample of the
dewatered WWTP sludge do
not exceed the levels
set forth in Condition
(1) of this exclusion,
Saturn can manage and
dispose the nonhazardous
dewatered WWTP sludge
according to all
applicable solid waste
regulations.
4. Annual Verification
Testing:
(i) If Saturn completes
the quarterly testing
specified in Condition
(3) above, and no sample
contains a constituent
with a level which
exceeds the limits set
forth in Condition (1),
Saturn may begin annual
verification testing on
an annual basis. Saturn
must collect and analyze
one sample of the WWTP
sludge on an annual
basis as follows: Saturn
must test one
representative composite
sample of the dewatered
WWTP sludge for all
constituents listed in
Condition (1) at least
once per calendar year.
(ii) The sample collected
for annual verification
testing shall be a
representative composite
sample consisting of
four grab samples that
will be collected in
accordance with the
appropriate methods
described in Condition
(1).
(iii) The sample for the
annual testing for the
second and subsequent
annual testing events
shall be collected
within the same calendar
month as the first
annual verification
sample. Saturn will
report the results of
the annual verification
testing to EPA on an
annual basis and will
include the
certification statement
required by Condition
(6).
5. Changes in Operating
Conditions: Saturn must
notify EPA in writing
when significant changes
in the manufacturing or
wastewater treatment
processes are
implemented. EPA will
determine whether these
changes will result in
additional constituents
of concern. If so, EPA
will notify Saturn in
writing that Saturn's
sludge must be managed
as hazardous waste F019
until Saturn has
demonstrated that the
wastes meet the
delisting levels set
forth in Condition (1)
and any levels
established by EPA for
the additional
constituents of concern,
and Saturn has received
written approval from
EPA. If EPA determines
that the changes do not
result in additional
constituents of concern,
EPA will notify Saturn,
in writing, that Saturn
must verify that
Saturn's sludge
continues to meet
Condition (1) delisting
levels.
6. Data Submittals:
Saturn must submit data
obtained through
verification testing at
Saturn or as required by
other conditions of this
rule to: Chief, North
Section, RCRA
Enforcement and
Compliance Branch, Waste
Management Division,
U.S. Environmental
Protection Agency Region
4, Sam Nunn Atlanta
Federal Center, 61
Forsyth Street SW,
Atlanta, Georgia 30303.
If Saturn fails to
submit the required data
within the specified
time or maintain the
required records on-site
for the specified time,
the EPA, at its
discretion, will
consider this sufficient
basis to re-open the
exclusion as described
in Condition (7). Saturn
must:
(A) Submit the data
obtained through
Condition (3) within the
time specified. The
quarterly verification
data must be submitted
to EPA in accordance
with Condition (3). The
annual verification data
and certification
statement of proper
disposal must be
submitted to EPA
annually upon the
anniversary of the
effective date of this
exclusion. All data must
be accompanied by a
signed copy of the
certification statement
in 40 CFR 260.22(i)(12).
(B) Compile, Summarize,
and Maintain Records:
Saturn must compile,
summarize, and maintain
at Saturn records of
operating conditions and
analytical data records
of analytical data from
Condition (3),
summarized, and
maintained on-site for a
minimum of five years.
Saturn must furnish
these records and data
when either the EPA or
the State of Tennessee
requests them for
inspection.
(C) Send along with all
data a signed copy of
the following
certification statement,
to attest to the truth
and accuracy of the data
submitted: ``I certify
under penalty of law
that I have personally
examined and am familiar
with the information
submitted in this
demonstration and all
attached documents, and
that, based on my
inquiry of those
individuals immediately
responsible for getting
the information, I
believe that the
submitted information is
true, accurate, and
complete. I am aware
that there are
significant penalties
for sending false
information, including
the possibility of fine
and imprisonment.''
7. Reopener.
(A) If, at any time after
disposal of the delisted
waste, Saturn possesses
or is otherwise made
aware of any data
(including but not
limited to leachate data
or groundwater
monitoring data)
relevant to the delisted
WWTP sludge at Saturn
indicating that any
constituent is at a
level in the leachate
higher than the
specified delisting
level or TCLP regulatory
level, then Saturn must
report the data, in
writing, to the Regional
Administrator within ten
(10) days of first
possessing or being made
aware of that data.
[[Page 54107]]
(B) Based upon the
information described in
Paragraph (A) and any
other information
received from any
source, the EPA Regional
Administrator will make
a preliminary
determination as to
whether the reported
information requires EPA
action to protect human
health or the
environment. Further
action may include
suspending, or revoking
the exclusion, or other
appropriate response
necessary to protect
human health and the
environment.
(C) If the Regional
Administrator determines
that the reported
information does require
EPA action, the Regional
Administrator will
notify Saturn in writing
of the actions the
Regional Adminis
[…truncated; see source link]Indexed from Federal Register on August 9, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.