Safe Management of Recalled Airbags, 61552-61563 [2018-25892]
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Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Rules and Regulations
section of
this preamble for more information).
FURTHER INFORMATION CONTACT
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V. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely approves state law as meeting
Federal requirements and does not
impose additional requirements beyond
those imposed by state law. For that
reason, this action:
• Is not a significant regulatory action
subject to review by the Office of
Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide the EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
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In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. The EPA will
submit a report containing this action
and other required information to the
U.S. Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
New Source Review, Particulate matter,
Reporting and recordkeeping
requirements.
Dated: October 11, 2018.
Deborah Jordan,
Acting Regional Administrator, Region IX.
Part 52, Chapter I, Title 40 of the Code
of Federal Regulations is amended as
follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart F—California
2. Section 52.220 is amended by
adding paragraphs (c)(458)(i)(A)(2) and
(c)(509) to read as follows:
■
Identification of plan—in part.
*
*
*
*
(c) * * *
(458) * * *
(i) * * *
(A) * * *
(2) Previously approved on May 1,
2015 in paragraph (c)(458)(i)(A)(1) of
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(f) The EPA is conditionally
approving a California State
Implementation Plan (SIP) revision
submitted on May 8, 2017, updating
Rule 1325—Federal PM2.5 New Source
Review Program, for the South Coast Air
Quality Management District. The
conditional approval is based on a
commitment from the State to submit a
SIP revision that will correct the
identified deficiencies. If the State fails
to meet its commitment by December
30, 2019, the conditional approval is
treated as a disapproval.
*
*
*
*
*
[FR Doc. 2018–25900 Filed 11–29–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 260, 261, and 262
Safe Management of Recalled Airbags
1. The authority citation for part 52
continues to read as follows:
■
*
§ 52.248 Identification of plan—conditional
approval.
[EPA–HQ–OLEM–2018–0646; FRL9986–91–
OLEM]
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
§ 52.220
this section and now deleted with
replacement in paragraph
(c)(509)(i)(A)(1), Rule 1325.
*
*
*
*
*
(509) New and amended regulations
for the following APCDs were submitted
on May 8, 2017 by the Governor’s
designee.
(i) Incorporation by reference. (A)
South Coast Air Quality Management
District.
(1) Rule 1325, ‘‘Federal PM2.5 New
Source Review Program’’ amended on
November 4, 2016.
(2) [Reserved]
(B) [Reserved]
(ii) [Reserved]
*
*
*
*
*
■ 3. Section 52.248 is amended by
adding paragraph (f) to read as follows:
Environmental Protection
Agency (EPA).
ACTION: Interim final rule with request
for comments.
AGENCY:
The Environmental Protection
Agency (EPA) is issuing this interim
final rule in response to the urgent
public health issue posed by recalled
Takata airbag inflators still installed in
vehicles. With this rule, EPA is
facilitating a more expedited removal of
defective Takata airbag inflators from
vehicles by dealerships, salvage yards
and other locations for safe and
environmentally sound disposal by
exempting the collection of airbag waste
SUMMARY:
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from hazardous waste requirements so
long as certain conditions are met. The
Agency is also seeking comment on this
interim final rule.
DATES: This interim final rule is
effective on November 30, 2018.
Comments must be received on or
before January 29, 2019. Under the
Paperwork Reduction Act (PRA),
comments on the information collection
provisions must be received on or before
January 29, 2019.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OLEM–2018–0646, at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
The EPA may publish any comment
received to its public docket. Do not
submit electronically any information
you consider to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Office of Resource Conservation and
Recovery, Materials Recovery and Waste
Management Division, MC 5304P,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460, Tracy Atagi, at (703) 308–8672,
(atagi.tracy@epa.gov).
SUPPLEMENTARY INFORMATION:
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Preamble Outline
I. General Information
II. Statutory Authority
III. When will this interim final rule be
effective?
IV. Background Information
A. Regulation of Airbag Modules and
Airbag Inflators Under RCRA
B. Background on the Takata Inflator
Recalls
C. Damage Incidents Related to Airbag
Inflator Recycling
D. Impact of Takata Bankruptcy and the
Amended Preservation Order on
Management of Takata Inflators
V. Rationale for Conditional Exemption for
Collection of Airbag Waste
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VI. Summary of Requirements of the
Conditional Exemption for Collection of
Airbag Waste
A. Applicability of Conditional Exemption
B. Limits on Accumulation Times and
Quantities at Airbag Waste Handlers
C. Packaging, Labeling and Transportation
Requirements for Airbag Waste Handlers
D. Tracking and Recordkeeping
Requirements for Airbag Waste Handlers
E. Prohibition on Reuse of Defective Airbag
Modules and Airbag Inflators
VII. State Authorization
VIII. Statutory and Executive Order (E.O.)
Reviews
I. General Information
A. Does this action apply to me?
This action applies to entities that
manage airbag waste (i.e., discarded
airbag modules and airbag inflators) that
are subject to hazardous waste
regulations. The dealerships performing
the Takata recall work constitute the
majority of the facilities that will be
impacted by this rule. These dealerships
fall under NAICS code 441: Motor
Vehicle and Parts Dealers. EPA
estimates that about 15,256 dealerships
may be affected by this rule. Other
potentially affected entities include
those in NAICS code 336:
Transportation Equipment
Manufacturing, and in NAICS code 562:
Waste Management and Remediation
Services.
B. Why is EPA issuing an interim final
rule?
Section 553(b)(B) of the
Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an
agency for good cause finds that notice
and public procedures are
impracticable, unnecessary or contrary
to the public interest, the agency may
issue a rule without providing notice
and an opportunity for public comment.
EPA has determined that there is good
cause for issuing this interim final rule
without prior proposal and opportunity
for comment because such notice and
opportunity for comment would be
impracticable and contrary to the public
interest. Specifically, prompt
promulgation of this rule without delay
is necessary to protect human health
and the environment by facilitating the
urgent removal of dangerously defective
Takata airbag inflators from vehicles,
and by preventing defective Takata
airbag inflators from scrap vehicles from
being reused, while maintaining
protection of human health and the
environment during airbag waste
collection, storage and disposal.
In its November 3, 2015 Coordinated
Remedy Order, the U.S. Department of
Transportation (DOT) National Highway
Traffic Safety Administration (NHTSA)
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found that it was imperative to
accelerate the rate of the recalls because
‘‘[e]ach airbag inflator with the capacity
to rupture, as the recalled Takata
inflators do, presents an unreasonable
risk of serious injury or death . . . Since
the propensity for rupture increases
with the age of the inflator, and
increases even more when the vehicle
has been exposed to consistent longterm HAH [high absolute humidity]
conditions, the risk for injurious or
lethal rupture increases with each
passing day.’’ 1 This report emphasizes
that as the inflators get older, each day
that passes brings forth an increased
danger. In addition, as noted in a
November 15, 2017 report prepared by
the Independent Monitor for the Takata
Restructuring on The State of the
Takata Recalls, ‘‘[t]he words ‘grenade’
and ‘ticking time bomb’ accurately
convey the lethal potential of these
defective inflators.’’ 2
Delaying promulgation of this rule
through notice and comment procedures
would be impracticable and contrary to
the public interest because such a delay
would further increase the risk of death
or serious injury by slowing down the
removal of defective Takata airbag
inflators from vehicles and impeding
the collection of defective airbag
inflators from salvage yards and other
locations (and increasing the potential
for defective airbag inflators in scrap
vehicles to be reused). This existing risk
has now increased significantly since
the date of the 2015 NHTSA report
because of recent events that further
heighten the urgency to accelerate the
recall.
First, more time has passed since the
date of the 2015 NHTSA study, and as
noted in that study and reiterated in the
2017 study by the Independent Monitor,
each passing day brings forth more
danger. The danger is greater today than
in 2015 because of the increased age of
the inflators.
Second, with the recent amendment
to DOT’s Preservation Order on April
12, 2018, and with Takata’s
restructuring due to bankruptcy
finalized on February 21, 2018, vehicle
manufacturers no longer have to send
recalled inflators to Takata warehouses
1 National Highway Traffic Safety Administration
(NHTSA), Coordinated Remedy Order, November 3,
2015, Docket No. NHTSA–2015–0055, paragraph
32. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/
documents/nhtsa-coordinatedremedyordertakata.pdf.
2 The Independent Monitor of Takata and the
Coordinated Remedy Program, The State of the
Takata Airbag Recalls, November 15, 2017, page 1,
paragraph 1. https://www.nhtsa.gov/sites/
nhtsa.dot.gov/files/documents/the_state_of_the_
takata_airbag_recalls-report_of_the_independent_
monitor_112217_v3_tag.pdf.
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for long-term storage but may now send
them directly for disposal. EPA is
encouraging this through today’s
conditional exemption, since long-term
storage of recalled inflators can make
the defect more dangerous. These
recalled inflators that are sent directly to
disposal are not covered by the
amended Preservation Order and thus
are regulated as hazardous waste,
whereas in the past they were not
regulated as waste under the original
Preservation Order. As a result, many
automobile dealers and other entities
who continue to replace recalled airbag
inflators at the current rate of repair
could become subject to additional
hazardous waste generator requirements
in 40 CFR part 262, which would
impose additional regulatory obligations
on the dealers’ and salvage vendors’
management of the inflators. Through
our conversations with DOT, the
automobile manufacturers, automotive
salvage vendors, and other affected
stakeholders, EPA has learned that
imposing full generator requirements on
automobile dealers and salvage vendors
who lack the expertise and experience
in managing hazardous waste would
result in the slowdown, rather than the
necessary acceleration, of the recall
effort, resulting in even greater harm to
human health and the environment.3
This rule is intended to assist the
automobile dealers and other entities in
their handling of the airbags, and ensure
delivery of the airbags to facilities that
can more expertly manage these airbags
in order to accelerate the recall. Thus,
it is essential that there be no delay in
promulgating this rule.
Third, there have continued to be
deaths as recently as 2018 as a result of
Takata airbag explosions. On January 1,
2018, there was a death in Malaysia 4,
and before that, on July 13, 2017, a
death in Australia 5 as well as another
on July 19, 2017 in Florida 6 as a result
of defective Takata airbags.
Finally, with respect to the effective
date, EPA finds that it has good cause
to make the revisions immediately
3 EPA 2018. Compilation of Stakeholder Meeting
Summaries Regarding RCRA Regulation of Airbag
Waste.
4 Confirmed Rupture of Takata Driver’s Airbag
Inflator in Malaysia on January 1, 2018 (Jan. 30,
2018), https://www.honda.com.my/corporate/press_
release_details/660/Confirmed-Rupture-of-TakataDriver%E2%80%99s-Airbag-Inflator-in-Malaysiaon-January-1,-2018.
5 Takata Recall: Sydney man was due to replace
airbag two days before fatal accident (last updated
Sept. 6, 2018), https://www.theguardian.com/world/
2018/sep/07/takata-recall-sydney-man-was-due-toreplace-airbag-two-days-before-fatal-accident.
6 20th death from faulty Takata airbags reported
by Honda (Dec. 20, 2017), https://
www.cbsnews.com/news/20th-death-from-faultytakata-air-bags-reported-by-honda/.
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effective under section 553(d) of the
Administrative Procedure Act (APA), 5
U.S.C. 553(d), and section 3010(b) of
RCRA, 42 U.S.C. 6930(b). Section 553(d)
provides in pertinent part that final
rules shall not become effective until 30
days after publication in the Federal
Register, ‘‘except . . . a substantive rule
which grants or recognizes an
exemption or relieves a restriction . . .
or as otherwise provided by the agency
for good cause’’. RCRA section 3010(b)
has similar provisions for an immediate
effective date. It provides for an
immediate effective date, rather than the
usual six month period, for ‘‘(1) a
regulation with which the
Administrator finds the regulated
community does not need six months to
come into compliance . . . . or (3) other
good cause found and published with
the regulation,’’ among other
exceptions.
The purpose of section 553(d) of the
APA is to ‘‘give affected parties a
reasonable time to adjust their behavior
before the final rule takes effect.’’
Omnipoint Corp. v. FCC, 78 F.3d 620,
630 (D.C. Cir. 1996); see also United
States v. Gavrilovic, 551 F.2d 1099,
1104 (8th Cir. 1977) (quoting legislative
history). Similarly, as noted above,
whether the regulated community needs
a period of time to come into
compliance is relevant to the
application of RCRA section 3010(b).
Because this rule grants a conditional
exemption from certain RCRA
hazardous waste requirements, it
qualifies for the APA exemption for any
rule that ‘‘recognizes or grants an
exemption or relieves a restriction’’ as
well as the RCRA exemption for any
rule for which ‘‘the regulated
community does not need six months to
come into compliance.’’
Moreover, EPA has determined that
for purposes of both the APA and RCRA
effective date provisions, there is good
cause for making this final rule effective
immediately. In determining whether
good cause exists to waive the 30-day
effective date under the APA, an agency
should ‘‘balance the necessity for
immediate implementation against
principles of fundamental fairness
which require that all affected persons
be afforded a reasonable amount of time
to prepare for the effective date of its
ruling.’’ Gavrilovic, 551 F.2d at 1105.
EPA has also applied this balancing test
to the RCRA effective date provision for
purposes of this rule. This rule
facilitates a more expedited removal of
defective Takata airbag inflators from
vehicles by dealerships, salvage yards
and other locations for safe and
environmentally sound disposal by
exempting the collection of airbag waste
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from hazardous waste requirements so
long as certain conditions are met.
Because this action provides an
exemption to certain requirements that
automobile dealers and other parties
would otherwise need to follow under
RCRA, and because this exemption is
optional, the regulated community does
not need time to prepare for this rule.
Specifically, as further discussed in this
preamble, the conditions for the
exemption mirror how recalled airbag
modules and airbag inflators have been
managed under the DOT Preservation
Order during the past three years, and
therefore no additional time is needed
to start operating under the exemption.
In contrast, the necessity of immediate
implementation is great, as previously
discussed.
As a result, EPA is making this
interim final rule effective upon
publication.
II. Statutory Authority
These regulations are promulgated
under the authority of sections 2002,
3001, 3002, 3003, 3004, 3006, 3010, and
3017 of the Solid Waste Disposal Act of
1965, as amended by the Resource
Conservation and Recovery Act of 1976
(RCRA), as amended by the Hazardous
and Solid Waste Amendments of 1984
(HSWA). This statute is commonly
referred to as ‘‘RCRA.’’
III. When will this interim final rule be
effective?
The revisions to 40 CFR 260.10, CFR
261.4 and CFR 262.14 become effective
on November 30, 2018.
IV. Background Information
A. Regulation of Airbag Modules and
Airbag Inflators Under RCRA
An airbag module is a fully assembled
unit including both the airbag inflator
and the fabric cushion. An airbag
inflator is the small metal canister
within the airbag module that generally
houses explosive propellant and an
initiator. The airbag module is deployed
when the airbag inflator receives an
electronic pulse from a vehicle’s crash
sensor. In properly functioning airbag
modules that use a gas generating
system, chemical propellant contained
in an airbag inflator unit burns in a fast
and controlled manner, quickly emitting
an inert gas through vents in the
canister out into the airbag module,
which inflates the cushion. Airbag
modules across the automobile safety
industry utilize explosive propellants
for rapid response to an automobile
accident.
Most airbag inflators use oxidizers as
part of the gas generating composition of
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the propellant and, therefore, when
discarded, would meet the definition of
ignitable hazardous waste under the
RCRA hazardous waste regulations at 40
CFR 261.21(a)(4), which states that a
solid waste exhibits the characteristic of
ignitability if, ‘‘[i]t is an oxidizer.’’ 7 In
addition, due to the explosive
propellant component, discarded airbag
modules and airbag inflators meet the
definition of reactive hazardous waste at
40 CFR 261.23(a)(6), which states that a
solid waste exhibits the characteristic of
reactivity if, ‘‘[i]t is readily capable of
detonation or explosive reaction if it is
subjected to a strong initiating source or
if heated under confinement.’’ 8 The
deployment of airbag inflators generally
results in the depletion of the ignitable
and/or reactive components to cause the
release of inert gas, after which the
inflators would no longer exhibit the
ignitable or reactive characteristics
under the RCRA regulations.
Airbag modules and airbag inflators
that exhibit hazardous waste
characteristics under 40 CFR part 261
subpart C may be exempt from
hazardous waste regulations under
certain scenarios, as summarized in an
EPA memorandum signed on July 19,
2018.9 As the memo explains, the
applicable RCRA hazardous waste
regulations for airbag modules and
airbag inflators depend on the type of
device, and how it is managed.
However, it is important to note that, as
the memo explains, recalled Takata
airbag modules and airbag inflators
removed from vehicles do not qualify
for the exemptions and exclusions
available to non-recalled airbag modules
and airbag inflators because, as
described in this preamble, the Takata
recalled airbag inflators cannot be safely
reused or deployed.
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B. Background on the Takata Inflator
Recalls
In May 2015, the U.S. Department of
Transportation (DOT) announced a
national recall of airbag inflators
manufactured by Takata due to a defect
in their phase-stabilized ammonium
nitrate (PSAN) propellant, which has
resulted in fifteen deaths and at least
250 injuries in the U.S. as of August
2018.10 These airbag inflator recalls
constitute the largest automotive recall
7 Ignitable hazardous waste carries the waste code
D001.
8 Reactive hazardous waste carries the waste code
D003.
9 U.S. EPA, Regulatory Status of Automotive
Airbag Inflators and Fully Assembled Airbag
Modules, July 19, 2018.
10 National Highway Traffic Safety
Administration (NHTSA), Takata Recall Spotlight.
https://www.nhtsa.gov/equipment/takata-recallspotlight.
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in U.S. history, with 19 vehicle
manufacturers affected and
approximately 65–70 million airbag
inflators scheduled to be recalled by
December 2019. Of these affected airbag
inflators, 50 million inflators in an
estimated 37 million vehicles were
recalled as of August 2018 and the
remaining inflators will be recalled by
December 2019.11 Included in this
number are tens of thousands of
‘‘Alpha’’ airbag inflators, which have a
significantly higher risk of rupture due
to a manufacturing defect resulting in
low-density propellant in addition to
the propellant defect described below.
Nine of the 15 fatalities in the U.S. were
caused by Alpha airbag inflators.12
On November 3, 2015, the National
Highway Traffic Safety Administration
(NHTSA) issued a Coordinated Remedy
Order that set forth the requirements
and obligations of certain motor vehicle
manufacturers and the airbag
manufacturer, Takata, in connection
with the recall and remedy of certain
types of Takata airbag inflators.13 In its
Coordinated Remedy Order, NHTSA
found that it was imperative to
accelerate the rate of the recalls because
‘‘[e]ach airbag inflator with the capacity
to rupture, as the recalled Takata
inflators do, presents an unreasonable
risk of serious injury or death. . . .
Since the propensity for rupture
increases with the age of the inflator,
and increases even more when the
vehicle has been exposed to consistent
long-term HAH [high absolute
humidity] conditions, the risk for
injurious or lethal rupture increases
with each passing day.’’ 14
The PSAN propellant used in the
recalled Takata airbag inflators degrades
over time when moist propellant is
exposed to long-term daily temperature
cycling. Moisture from the air adsorbs to
PSAN particles, changing the structure
of the propellant and causing the
inflator to over-pressurize during
deployment.15 In some cases, this over11 Id.; National Highway Traffic Safety
Administration (NHTSA), The State of Takata
Recalls, https://www.nhtsa.gov/recall-spotlight/
state-takata-recalls.
12 National Highway Traffic Safety
Administration (NHTSA), Takata ‘‘Alpha’’ Airbags
Pose Increased Risk, https://www.nhtsa.gov/recalls/
takata-alpha-air-bags-pose-increased-risk.
13 National Highway Traffic Safety
Administration (NHTSA), Coordinated Remedy
Order, November 3, 2015, Docket No. NHTSA–
2015–0055. https://www.nhtsa.gov/sites/
nhtsa.dot.gov/files/documents/nhtsa-coordinated
remedyorder-takata.pdf.
14 Ibid, paragraph 32.
15 National Highway Traffic Safety
Administration (NHTSA), Expert Report of Harold
R. Blomquist, Ph.D., May 4, 2016. https://
www.nhtsa.gov/sites/nhtsa.dot.gov/files/
documents/expert_report-hrblomquist.pdf.
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pressurization causes the metal canister
to rupture, producing shrapnel-like
metal shards during airbag inflation. To
mitigate these effects, Takata began
manufacturing PSAN airbag inflators
containing desiccant to prevent the
adsorption of moisture to the PSAN
particles. While some inflators with
desiccant have been recalled, others are
still under evaluation and may or may
not be recalled in the future.16
A 2015 Safety Data Sheet (SDS) for
Takata pyrotechnic automotive safety
devices, including airbag modules and
airbag inflators, describes the hazards of
the devices, including an ‘‘[i]nitiation
hazard of an uncontrolled activation of
the safety device due to: Fire; heat;
electrostatic discharge; inductions
through electromagnetic radiation; or,
excessive mechanical load’’ and a
‘‘[b]urn hazard when there is direct
contact with pyrotechnic safety device
during activations.’’ 17 The firefighting
measures described in the SDS include
evacuating personnel and emergency
responders for 1500 feet (1⁄3 mile). In the
event of spilled material from damaged
devices, the SDS recommends that an
explosive expert conduct the cleanup
using anti-static equipment.
Propagation and bonfire testing
results submitted to EPA by Takata
provides further information regarding
the hazards posed by recalled Takata
inflators.18 In September 2016, a thirdparty company performed sympathetic
propagation testing on two types of
recalled Takata airbag inflators for
Takata. The testing generally consisted
of bundling several inflators together
and deploying the center inflator in
order to observe the effects of
deployment on the surrounding
inflators. The results of the testing
showed that deployment of one inflator
does not cause deployment of
surrounding inflators. In some tests, the
center inflator fragmented, but it still
did not cause surrounding inflators to
deploy or fragment, although some
superficial damage to the surrounding
inflators did occur. In April 2017, a
third-party company performed the UN
6(c) external fire (bonfire) test on
recalled Takata airbag inflators in
individual fiberboard boxes. The
inflators did not mass detonate when
exposed to fire, but they did initiate, as
16 National Highway Traffic Safety
Administration (NHTSA), New Takata recall
involves Nissan, Ford, and Mazda vehicles, https://
www.nhtsa.gov/recall-spotlight/new-takata-recallinvolves-nissan-ford-and-mazda-vehicles.
17 Takata Safety Data Sheet (SDS)—Pyrotechnic
Automotive Safety Devices, January 2015.
18 Testing information was submitted as
confidential business information (CBI). The
summary of results in this preamble does not
contain CBI.
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would be expected when inflators are
exposed to temperatures generated by
this type of fire. In some cases, they
were propelled from their initial
locations of rupture, throwing fragments
beyond the initial location of the
inflator.
C. Damage Incidents Related to Airbag
Inflator Recycling
While non-Takata airbag inflators do
not present the same shrapnelproducing defect as recalled Takata
airbag inflators, these airbag inflators
can still present an explosive risk when
processed or recycled, as demonstrated
by recent incidents at two facilities. In
February 2015, an explosion and fire
occurred at one airbag manufacturing
and recycling facility as two workers
handled airbag inflators that had been
processed in an incinerator prior to
recycling the metal.19 In that incident,
one worker was hospitalized with head
injuries and burns. In March 2018, a
large explosion at a different airbag
recycling facility in the dedicated airbag
recycling area killed one worker and
seriously injured another.20 This
explosion is suspected to have been
caused by the ignition of aluminum
dust, which was created in the process
of shredding airbag inflators. These
incidents demonstrate the
characteristically hazardous nature of
waste airbag inflators and their
component materials and the potential
risk they pose to human health during
processing.
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D. Impact of Takata Bankruptcy and the
Amended Preservation Order on
Management of Takata Inflators
2015 Preservation Order
A Preservation Order issued by DOT
and signed by Takata in February 2015
required all recalled airbag inflators be
preserved intact, except for those
utilized for testing purposes. Takata was
required to take all reasonable and
appropriate steps designed to prevent
the partial or full destruction, alteration,
deletion, shredding, incineration or loss
of recalled or returned inflators,
ruptured inflators and any other
inflators under the recalls. The recalled
Takata inflators were organized into
categories of inflators that must be
preserved. Ruptured inflators from field
events were required to be preserved in
a locked, secured, climate-controlled
area, except for testing, inspection or
19 U.S. EPA, Autoliv Promontory Facility (20 June
2017), July 24, 2018.
20 Tennessee Occupational Safety and Health
Administration, Redacted Report: Lighting
Resources LLC Explosion on March 14, 2018,
August 16, 2018.
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analysis purposes. Recalled or returned
inflators were also to be kept in a
locked, secured and climate-controlled
area.
EPA June Memorandum
In the June 23, 2017 memorandum,
EPA clarified that the recalled Takata
airbag inflators are not subject to RCRA
Subtitle C regulatory requirements
while they are being held under the
2015 DOT Preservation Order because
EPA does not consider materials being
stored pending judicial proceedings or
investigations to be ‘‘discarded.’’ This
interpretation is consistent with
previous interpretations EPA has taken
on similar materials, such as seized
fireworks held as evidence and
materials from aircraft accidents subject
to investigation, where such items
would otherwise be considered
hazardous waste.21 22 Additionally, EPA
clarified that Takata recalled airbag
inflators would be considered ‘‘used’’
(i.e., spent materials), and therefore a
solid waste, once the preservation
requirements are lifted. When the
recalled Takata airbag inflators are
discarded as a solid waste, EPA believes
that they meet both the ignitability and
reactivity hazardous waste
characteristics.23
Impact of Takata Bankruptcy on Recall
Procedures
Takata’s U.S. subsidiary, TK Holdings
Inc., filed for Chapter 11 bankruptcy on
June 25, 2017, and received U.S. court
approval for its plan on February 21,
2018.24 Takata’s manufacturing assets
were sold to Key Safety Systems,
another automobile safety system
manufacturer, and the money from the
sale was used to settle debts and legal
claims. A small portion of the company
emerged from bankruptcy and has a
section dedicated to facilitating the
replacement of recalled airbag
inflators.25 Takata’s plan sets aside
funds designated for the removal,
handling and eventual disposal of
recalled airbag inflators received before
the effective date of the bankruptcy,
21 U.S. EPA, Explosives Presenting an Immediate
Safety Threat and Explosives Stored During
Analysis, August 11, 1988. RCRA Online 11363.
22 U.S. EPA, Management of Aircraft Remains
from Catastrophic Loss Events, January 6, 2014.
RCRA Online 14881.
23 Ignitable waste code D001 (40 CFR
261.21(a)(4)). Reactive waste code D003 (40 CFR
261.23(a)(6)).
24 Prime Clerk, Takata TK Holdings Inc
Bankruptcy Case Information, https://restructuring.
primeclerk.com/takata/Home-Index.
25 To avoid confusion, the entities responsible for
managing the Takata airbag inflator recalls,
including Takata’s post-bankruptcy successor
company TK Global, will collectively be referred to
as ‘‘Takata’’ in this preamble.
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April 10, 2018, and states that Takata
will continue to provide replacement
airbag inflators until the recall process
is finished, expected in 2020.26 Takata
will also continue to receive recalled
airbag inflators for storage prior to
testing or eventual disposal after April
10, 2018, although it is not required to
do so. EPA’s understanding is that
Takata will charge the automobile
manufacturers to cover the costs
associated with storage and eventual
disposal of these inflators received after
April 10, 2018. These costs include the
overhead expenses associated with
Takata managing the collection, storage,
and disposal of airbag inflators,
including wages and benefits for their
workers that are involved in handling
and coordinating the movement of the
inflators. Prior to the bankruptcy
effective date, Takata accepted and
managed these inflators from the
affected vehicle manufacturers free of
charge.
2018 Amended Preservation Order
The April 12, 2018 Amendment to the
February 25, 2015 Preservation Order
and Testing Control Plan, issued by the
U.S. DOT’s NHTSA, requires Takata to
preserve certain airbag inflators that are
the subject of an ongoing defect
investigation by NHTSA and the subject
of private litigation.27 The Amendment
also requires Takata to implement a
control plan for the inspection, testing,
or analysis of those inflators.
The original 2015 Preservation Order
required Takata to preserve indefinitely
all affected airbag inflators, while the
2018 Amendment enables Takata to
reduce the number of preserved airbag
inflators by requesting the release of
certain inflators from the Preservation
Order allowing them to be disposed in
compliance with all applicable
regulations, including RCRA. The
Amended Order also requires Takata to
account for returned foreign and other
ammonium-nitrate containing inflators.
The Amendment applies to Takata
airbag inflators removed from vehicles
as a result of recalls affecting the 19
vehicle manufacturers.
The terms of the Amendment require
Takata to track all airbag inflators in its
possession by unique serial number and
set aside at least 5% of inflators,
26 U.S. Bankruptcy Court—District of Delaware,
Fifth Amended Joint Chapter 11 Plan of
Reorganization of TK Holdings Inc. and its
Affiliated Debtors, filed February 20, 2018.
27 National Highway Traffic Safety
Administration (NHTSA), Amendment to the
February 25, 2015 Preservation Order and Testing
Order Control Plan, April 12, 2018, EA15–001
(formerly PE14–016). https://www.nhtsa.gov/sites/
nhtsa.dot.gov/files/documents/preservation_order_
amendment_public_-_april_12_2018-tag.pdf.
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proportionate to the overall number of
inflators received from each State and of
each type of inflator, for future analysis.
The Amendment allows Takata to
submit Disposal Designations to
NHTSA, identifying a specific quantity
of inflators to be released from
preservation and disposed. The
designated inflators are considered
released from the Preservation Order
fifteen business days after NHTSA’s
confirmation of receipt of the Disposal
Designation.
Although the affected vehicle
manufacturers may choose to contract
with Takata’s post-bankruptcy
reorganized entity to transport and store
recalled airbag inflators, they are not
required to do so by the Preservation
Order or Amendment. If a vehicle
manufacturer chooses to contract with
the Takata entity, the Takata entity must
preserve those airbag inflators under the
terms of the Preservation Order, and
therefore those airbag inflators are not
solid wastes per EPA’s June 23, 2017
memorandum as described above.
However, a vehicle manufacturer may
choose not to contract with the Takata
entity for a variety of reasons, including
increased cost, increased liability, and
slower disposal, in which case those
airbag inflators would not be covered by
the Preservation Order or Amendment,
and would be considered discarded
when removed from the vehicle.
V. Rationale for Conditional Exemption
for Collection of Airbag Waste
In its 2015 Coordinated Remedy
Order pertaining to the Takata airbag
recalls, DOT found that it was
imperative to accelerate the rate of the
recalls because ‘‘[e]ach airbag inflator
with the capacity to rupture, as the
recalled Takata inflators do, presents an
unreasonable risk of serious injury or
death. . .Since the propensity for
rupture increases with the age of the
inflator, and increases even more when
the vehicle has been exposed to
consistent long-term HAH [high
absolute humidity] conditions, the risk
for injurious or lethal rupture increases
with each passing day.’’ 28
Since the original order was issued by
DOT, the affected vehicle manufacturers
have been working steadily to remove
the recalled Takata airbag inflators from
vehicles. As discussed earlier, because
of DOT’s Preservation Order, the
recalled airbag inflators have not been
regulated as hazardous waste and have
28 National Highway Traffic Safety
Administration (NHTSA), Coordinated Remedy
Order, November 3, 2015, Docket No. NHTSA–
2015–0055. https://www.nhtsa.gov/sites/
nhtsa.dot.gov/files/documents/nhtsa-coordinated
remedyorder-takata.pdf.
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instead been safely collected,
transported as hazardous materials and
stored under the Preservation Order.
With the amendment to DOT’s
Preservation Order and with Takata’s
restructuring due to bankruptcy, vehicle
manufacturers may now dispose of
recalled inflators that are not covered by
the amended Preservation Order
directly, rather than sending them to the
Takata warehouses for long-term
storage. This approach is preferable
from a public health and environmental
protection perspective both because it
reduces the volume of inflators in longterm storage and because it is more
efficient in freeing up resources spent
on handling and storage that can be
spent directly on the recalls themselves.
However, because this subset of
recalled inflators is not subject to the
DOT Preservation Order, they would be
regulated as hazardous waste. As a
result, many automobile dealers and
other entities who continue to replace
recalled airbag inflators at the current
rate of repair would become subject to
additional hazardous waste generator
requirements in 40 CFR part 262, which
would impose additional regulatory
obligations on the dealers’ and salvage
vendors’ management of the inflators.
Most automobile dealers and salvage
vendors are currently in the category of
‘‘Very Small Quantity Generators’’ of
hazardous waste. By managing
hazardous airbag waste, the dealers and
salvage vendors would likely generate
sufficient amounts of hazardous waste
(on a monthly basis) to become subject
to increased regulations associated with
higher generator categories for which
dealers and salvage vendors typically
have not had experience, familiarity, or
expertise. Imposing these increased
generator obligations on dealers and
salvage vendors would result in a much
less efficient, effective and
environmentally protective approach to
the urgent, time-critical recall effort.
Through our conversations with DOT,
the automobile manufacturers,
automotive salvage vendors, and other
affected stakeholders, EPA has learned
that imposing full generator
requirements on automobile dealers and
salvage vendors who lack the expertise
and experience in managing hazardous
waste might result in the slowdown,
rather than the necessary acceleration,
of the recall effort, resulting in greater
harm to human health and the
environment.29 The automobile
manufacturers are worried that, because
of their lack of familiarity and expertise
29 EPA 2018. Compilation of Stakeholder Meeting
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with full RCRA hazardous waste
generator regulations and the additional
costs related to the management of
hazardous waste in these higher
generator categories, if the dealers were
to become fully regulated small or large
quantity generators due to handling
recalled airbag waste, they may slow
down or stop removing recalled airbag
inflators altogether. In addition, some
stakeholders have expressed their
concern of a lack of hazardous waste
transportation capacity, especially in
more sparsely populated rural areas of
the country. As hazardous waste
generators, dealers would be required to
use certified hazardous waste
transporters, which are less numerous
and more expensive than standard
hazardous material transporters used to
transport recalled inflators under the
DOT preservation order. Thus, placing
full hazardous waste generator
requirements on dealers or salvage yards
would not be the most efficient or
environmentally protective approach for
the above reasons. In contrast, as
explained in the following section, an
airbag waste collection facility under
the control of a vehicle manufacturer or
their authorized representative or under
the control of an authorized party
administering a remedy program in
response to the recalls or a designated
facility as defined in 40 CFR 260.10, has
greater expertise and familiarity in
properly managing hazardous waste.
A related but separate issue involves
airbag modules and airbag inflators
scavenged from scrapped automobiles.
One vendor company has been involved
in the collection of Takata airbag
modules from the approximately 6,000
salvage yards in the United States. The
company was approached by one
automobile manufacturer after they
discovered a number of injuries were
caused by recalled Takata airbag
inflators recovered from salvage yards
and installed in other vehicles. The
salvage vendor worked with the
automobile manufacturer, DOT, and the
independent monitor to put together a
program to retrieve airbag modules
containing recalled airbag inflators
before the inflators can be removed and
placed in another vehicle because at
that point, they are virtually
untraceable. The vendor collects the
airbag and brings them to a central
location where they undergo a
validation step to determine whether
they are definitively recalled airbag
inflators. This validation includes using
visual aids and scanning all VIN and
serial numbers. The vendor also
supplies specifically designed
packaging and handles the
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transportation for the airbag modules.
Once a pallet of validated airbag
modules is collected (approximately
100–110 pieces), the pallet is sent for
disposal and a certificate of destruction
is provided. The airbag modules are
transported in compliance with DOT
hazardous materials regulations.
According to this vendor, if the airbag
modules must be handled as RCRA
hazardous waste when removed from a
vehicle in the salvage yard, the salvage
yards would likely stop removing them.
Due to the potential for the
replacement of defective Takata airbag
inflators to slow down with the
application of full RCRA generator
requirements, EPA has determined that
modified RCRA requirements are
appropriate for automobile dealers,
salvage yards, and other entities that are
removing the recalled airbag inflators
and facilitating the recalls.
As discussed earlier, any potential
delay to the recalls presents an
immediate public health threat,
increasing the chances of death or
serious injury due to a defective airbag
deploying in a vehicle. Moreover, the
system for managing the recalled airbag
modules and inflators under the DOT
Preservation Order over the last three
years has provided for protection of
human health and the environment
during collection and transport of the
airbag modules and inflators. Under the
recalls, each individual recalled inflator
is tracked by vehicle identification
number, and subject to DOT packaging
and transportation regulations. Vehicle
manufacturers work with their dealers
to make sure that the recalled inflators
are quickly moved offsite and not overaccumulated, and have a strong
incentive from a liability perspective to
continue to do so in the future.
The conditions for the exemption
promulgated by this rule mirror how
recalled airbag modules and airbag
inflators have been managed under the
DOT Preservation Order during the past
three years, except that instead of going
to long-term storage under the
Preservation Order, the collected airbag
waste will be sent for safe disposal at a
RCRA facility designated to receive
hazardous waste per 40 CFR 260.10.
Thus, exempting the collection of airbag
waste from RCRA requirements,
provided certain conditions are met,
will result in an increase in protection
of public health by facilitating the
recalls, allowing the current airbag
waste collection system to continue to
safely collect the recalled inflators, and
sending them directly to appropriate
disposal facilities rather than to longterm storage facilities under the
Preservation Order.
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As previously explained in other
rulemakings, EPA has authority under
RCRA to issue conditional exclusions
from the hazardous waste regulations.
EPA has previously interpreted RCRA
section 3001(a) to authorize the issuance
of ‘‘conditional exemptions’’ from the
requirements of RCRA Subtitle C, where
it determines that ‘‘a waste might pose
a hazard only under limited
management scenarios, and other
regulatory programs already address
such scenarios.’’ 62 FR at 6636
(February 12, 1997); 66 FR at 27222–
27223 (May 16, 2001). The final rule
takes a similar approach to those earlier
rules.
Section 3001(a) requires that EPA
decide whether a waste ‘‘should be
subject to’’ the requirements of RCRA
Subtitle C. Hence, RCRA section 3001
authorizes EPA to determine when
subtitle C regulation is appropriate. EPA
has consistently interpreted section
3001 of RCRA to give it broad flexibility
in developing criteria for hazardous
wastes to enter or exit the Subtitle C
regulatory system.
RCRA section 1004(5) further
supports EPA’s interpretation. This
interpretation has also been upheld
upon judicial review. See, e.g., Military
Toxics Project v. EPA, 146 F. 3d 948 (DC
Cir. 1998) (upholding conditional
exemption for storage of military
munitions, based on EPA determination
that such wastes are subject to binding
standards that meet or exceed RCRA
standards, in addition to an institutional
oversight process.) EPA has interpreted
the statutory definition of hazardous
waste in RCRA section 1004(5)(B) as
incorporating the idea that a waste that
is otherwise hazardous does not require
regulation under RCRA so long as it is
properly managed.
EPA has most recently provided a full
discussion of EPA’s authority for
conditional exclusion from RCRA
Subtitle C requirements in the preamble
in its final rule entitled Hazardous
Waste Management System: Conditional
Exclusion for Carbon Dioxide (CO2)
Streams in Geologic Sequestration
Activities, 79 FR 350, 353–354 (January
3, 2014). Consistent with that rule, and
other rules involving conditional
exemptions, EPA has determined in this
rule, as discussed above, that exempting
the collection of airbag waste from
RCRA requirements, provided certain
conditions are met, will result in an
increase in protection of public health
by facilitating the recalls and allowing
the current airbag waste collection
system to continue to safely collect the
recalled inflators. It is important to note,
however, that this conditional
exemption only applies to the storage
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and transport of airbag waste during
collection. The final disposition of the
hazardous airbag waste continues to be
regulated under applicable RCRA
Subtitle C hazardous waste regulations.
EPA has received requests from
stakeholders to unconditionally exempt
airbag modules and inflators from RCRA
hazardous waste regulations.30
However, EPA has determined, based on
the nature of the waste and the damage
cases that have occurred at airbag
recycling facilities, an exemption for the
final disposition of airbag waste would
not be protective of human health and
the environment. While the collection of
intact airbag modules and inflators by
vehicle manufacturers or their
authorized representatives according to
DOT requirements can be done safely
without imposing RCRA requirements
beyond the conditions of the exemption
discussed in this preamble, processing
the airbag inflator, which requires
treatment of the ignitable and reactive
propellant inside the inflator, is another
matter. As discussed earlier, there have
been at least two explosions at airbag
recycling facilities, including one that
resulted in a fatality, and in the case of
the recalled Takata airbag inflators, the
degraded nature of the propellant makes
the potential for explosive reactions
even worse. The protections provided
by a RCRA Subtitle C hazardous waste
permitted facility, including personnel
training, inspections, contingency
planning and emergency response, and
an informed community through public
participation address the risk of
explosion from the end-of-life
management of the collected airbag
waste.
EPA solicits comment on the
conditional exemption for airbag waste,
including the applicability of the
exemption and the specific
requirements of this conditional
exemption as explained in this
preamble. EPA will consider these
comments in determining whether any
additional revisions to the regulation of
airbag waste are necessary in the future.
VI. Summary of Requirements of the
Conditional Exemption for the
Collection of Airbag Waste
A. Applicability of Conditional
Exemption
The new airbag waste conditional
exemption found at 40 CFR 261.4(j)
applies to all airbag waste (i.e., airbag
modules and airbag inflators) collected
from auto dealers or other airbag waste
handlers for the purpose of safe
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disposal. Entities that generate airbag
waste under the conditional exemption
are referred to as ‘‘airbag waste
handlers’’ and can include automobile
dealers, independent repair facilities,
collision centers, and salvage and scrap
yards.
The vast majority of items affected by
the conditional exemption will be
Takata airbag waste. As of August 2018,
an estimated 50 million defective airbag
inflators were under recall in
approximately 37 million U.S. vehicles,
with the potential for more recalls to be
issued in the future.
However, EPA has determined that
the conditional exemption should also
apply to the collection of non-Takata
airbag waste for the purpose of disposal,
provided that the conditions of the
exemption are met. Managing all airbag
waste under the same protective
requirements will avoid confusion,
increase efficiency and will help
prevent non-Takata airbag waste from
being diverted into the municipal waste
stream. Because non-Takata airbag
waste is expected to be a much smaller
volume waste than the recalled Takata
airbag waste, in many cases automobile
dealers that generate hazardous waste
would be below the Very Small
Quantity Generator threshold of 100
kilograms/month, which under the
federal RCRA requirements in 40 CFR
262.14 would allow the non-Takata
airbag waste to be disposed of in the
municipal wastestream. Including these
materials under the airbag waste
conditional exemption is more
protective of human health and the
environment because it would
encourage their disposal at hazardous
waste management facilities. To make it
clear that VSQGs have the option of
managing their airbag waste under the
airbag waste conditional exemption and
sending their airbag waste to an airbag
waste collection facility or a designated
facility subject to the requirements of 40
CFR part 261.4(j), EPA is including a
conforming change to the VSQG
regulations at 40 CFR 262.14(a)(xi).
(Note that the airbag waste conditional
exemption does not prevent the airbag
modules or airbag inflators from being
managed under other applicable
exemptions as explained in the July
2018 memo referenced in section IV.A.
in this preamble) In addition, EPA also
requests comment on expanding the
applicability of the airbag waste
exemption to include other similar
propellent-actuated devices and their
components. It would be helpful if
commenters include detailed
information on these additional
wastestreams, including descriptions of
the wastestreams, volumes generated,
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risks posed and current management
practices.
B. Limits on Accumulation Times and
Quantities at Airbag Waste Handlers
Based on information provided by
automobile manufacturers, automobile
dealers limit the quantity of recalled
airbag modules and inflators stored
onsite. According to one automobile
manufacturer, guidance provided by
Takata requires that dealers ship out the
recalled airbag inflators that have been
removed from vehicles every two weeks,
or when the quantity reaches 200
inflators (i.e., a small truckload).31
Limiting the quantity and
accumulation times at airbag waste
handlers for airbag waste prevents overaccumulation and limits the potential
hazards posed by the inflators in case of
a fire. Under the airbag waste exemption
finalized in this action, airbag waste
handlers are allowed to accumulate up
to 250 airbag modules or airbag inflators
for up to 180 days, whichever comes
first. Limiting the quantity of airbag
modules and airbag inflators
accumulated onsite to 250 (i.e., a little
over one small truckload) allows the
dealer and other airbag waste handlers
to prepare one truckload for shipping
while continuing to accumulate airbag
waste for future shipments. The 180-day
timeframe is based on the small quantity
generator limits in 40 CFR 262.16, and
addresses the future situation when the
Takata recalls near completion,
resulting in a slower turn-around in
recalled inflators accumulated at the
dealer. At that point it may take much
longer to reach the 250-item limit, and
the 180-day time limit ensures storage
does not extend indefinitely, and that
the airbag waste is safely disposed and
not abandoned.
C. Packaging, Labeling and
Transportation Requirements for Airbag
Waste Handlers
During accumulation under the airbag
waste exemption, airbag waste must be
packaged in a container designed to
address the risk posed by the airbag
waste. Such a container would help
reduce the potential for the airbag waste
to react in case of a fire, and also reduce
the projectile hazard if the defective
Takata airbag inflators were to deploy.
In most cases, this container would be
the same container that the replacement
airbag part was shipped in to the airbag
handler, or, in the case of salvage yards,
the container provided by the salvage
recovery vendor. However, any
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container that meets DOT requirements
for transporting the airbag items would
meet the terms of the conditional
exemption. Each container must be
labeled ‘‘Airbag Waste—Do Not Reuse.’’
Airbag waste must be shipped directly
to either (1) a designated facility as
defined in 40 CFR 260.10, or (2) an
airbag waste collection facility in the
United States under the control of a
vehicle manufacturer or their authorized
representative, or under the control of
an authorized party administering a
remedy program in response to a recall
under the National Highway Traffic
Safety Administration. Airbag waste
collection facilities may include part
supply centers/parts distribution centers
or any other facility authorized by
vehicle manufacturers to collect their
airbag waste and hold it for more than
10 days. (Airbag waste held at a transfer
facility for less than 10 days is
considered to be in transport and only
subject to the DOT transportation
regulations). Because the airbag waste is
not subject to hazardous waste generator
requirements under 40 CFR part 262
while at the airbag waste handler, the
designated facility or the airbag waste
collection facility that accepts the airbag
waste from the airbag waste handler is
considered the hazardous waste
generator for the purposes of 40 CFR
part 262 as the person whose act first
causes a hazardous waste to become
subject to the generator regulations.
D. Tracking and Recordkeeping
Requirements for Airbag Waste
Handlers
As a condition for exemption from
RCRA hazardous waste requirements,
airbag waste handlers must maintain at
the facility and make available upon
inspection certain records that
document off-site shipments of airbag
waste for a period of three years to help
verify the airbag waste went to an
appropriate destination. Specifically, for
each shipment of airbag waste, the
handler must maintain documentation
of the date of each shipment, the name
of each transporter, the type and
quantity of airbag waste (i.e., airbag
modules or airbag inflators) shipped,
and the name and address of the
destination facility or airbag waste
collection facility. This recordkeeping
requirement may be fulfilled by
ordinary business records, such as bills
of lading, including electronic records.
In addition, airbag waste handlers are
required to maintain confirmations of
receipt from the designated facility or
airbag waste collection facility in order
to verify that the airbag waste reached
its intended destination and was not
diverted. These receipts must be
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maintained at the airbag waste handler
for a period of three years. Specifically,
the airbag waste handlers must maintain
documentation of receipt that includes
the name and address of the designated
facility or airbag waste collection
facility, the type and quantity of airbag
waste (i.e., airbag modules or airbag
inflators) received, and the date which
it was received. The Agency is not
requiring a specific template or format
for confirmations of receipt and
anticipates that routine business records
(e.g., financial records, bills of lading,
copies of DOT shipping papers,
electronic confirmations of receipt, etc.)
could contain the appropriate
information sufficient for meeting this
requirement. Note that these
recordkeeping requirements will be
implemented under an emergency
Information Collection Request (ICR).
Based on the public comments received
on this rule, EPA will publish a separate
revised ICR. See Section VIII.C in this
preamble.
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E. Prohibition on Reuse of Defective
Airbag Modules and Airbag Inflators
While used airbag modules and used
airbag inflators are not solid waste when
reused for their intended purpose, in the
case of airbag modules and airbag
inflators that are subject to a recall
under the National Highway Traffic
Safety Administration, such reuse is not
allowed under RCRA. Reuse of recalled
Takata inflators is particularly
dangerous due to the shrapnel
producing defect that can cause death or
serious injury when the airbag is
deployed, even when the vehicle
accident would otherwise be considered
minor. As noted in a report by the
Takata Independent Monitor, salvaged
Takata inflators may pose an even
greater risk than other defective Takata
inflators due to possible exposure to
high heat and humidity for an extended
time in the scrap vehicles. In one case,
a vehicle that was repaired with a
salvaged Takata airbag inflator was
involved in a minor accident. The
resulting shrapnel from deployment of
the defective resulted in serious injury
to the driver. The family owning the car
had no reasonable way of knowing that
it contained a defective inflator.32 Any
person who reuses a defective inflator or
causes it to be reused may therefore be
placing another person in imminent
danger of death or serious injury. Such
32 National Highway Traffic Safety
Administration (NHTSA), The State of Takata
Airbag Recalls—Report of the Independent Monitor,
November 15, 2017. https://www.nhtsa.gov/sites/
nhtsa.dot.gov/files/documents/the_state_of_the_
takata_airbag_recalls-report_of_the_independent_
monitor_112217_v3_tag.pdf.
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a reuse would not meet the definition of
legitimate recycling in 40 CFR 260.43
and would be considered sham
recycling under 40 CFR 261.2(g).
Specifically, because the defective
airbag modules and airbag inflators
cannot serve as an effective substitute
for a commercial product, and do not
otherwise provide a useful contribution
per 40 CFR 260.43(a)(1), their reuse is
considered to be sham recycling and
prohibited under the hazardous waste
regulations.
VII. State Authorization
A. Applicability of Rules in Authorized
States
Under section 3006 of RCRA, EPA
may authorize a qualified state to
administer and enforce a hazardous
waste program within the state in lieu
of the federal program, and to issue and
enforce permits in the state. A state may
receive authorization by following the
approval process described in 40 CFR
271.21 (see 40 CFR part 271 for the
overall standards and requirements for
authorization). EPA continues to have
independent authority to bring
enforcement actions under RCRA
sections 3007, 3008, 3013, and 7003. An
authorized state also continues to have
independent authority to bring
enforcement actions under state law.
After a state receives initial
authorization, new federal requirements
and prohibitions promulgated under
RCRA authority existing prior to the
1984 Hazardous and Solid Waste
Amendments (HSWA) do not apply in
that state until the state adopts and
receives authorization for equivalent
state requirements. In contrast, under
RCRA section 3006(g) (42 U.S.C.
6926(g)), new federal requirements and
prohibitions promulgated under HSWA
provisions take effect in authorized
states at the same time that they take
effect in unauthorized states. As such,
EPA carries out the HSWA requirements
and prohibitions in authorized states,
including the issuance of new permits
implementing those requirements, until
EPA authorizes the state to do so.
Authorized states are required to
modify their programs only when EPA
enacts federal requirements that are
more stringent or broader in scope than
existing federal requirements. Under
RCRA section 3009, states may impose
standards that are more stringent or
broader in scope than those in the
federal program (see also 40 CFR
271.1(i)). Therefore, authorized states
are not required to adopt new federal
regulations that are considered less
stringent than previous federal
regulations or that narrow the scope of
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the RCRA program. Previously
authorized hazardous waste regulations
would continue to apply in those states
that do not adopt ‘‘deregulatory’’ rules.
B. Effect on State Authorization of
Interim Final Rule
The regulations finalized in this
interim final rule are not promulgated
under the authority of HSWA. Thus, the
standards will be applicable on the
effective date only in those states that
do not have final authorization of their
base RCRA programs. Moreover,
authorized states are required to modify
their programs only when EPA
promulgates federal regulations that are
more stringent or broader in scope than
the authorized state regulations. For
those changes that are less stringent,
states are not required to modify their
program. Pursuant to section 3009 of
RCRA, states may impose more stringent
regulations than the federal program.
This rule eliminates specific hazardous
waste requirements that would
otherwise apply to airbag waste (airbag
modules and airbag inflators) managed
under the conditional exemption, and
therefore, these changes are less
stringent than the federal program and
authorized states are not required to
adopt them. However, if a state were,
through implementation of state waiver
authorities or other state laws, to allow
compliance with the provisions of the
conditional exemption in advance of
adoption or authorization, EPA would
not generally consider such
implementation a concern for purposes
of enforcement or state authorization. Of
course, the state could not implement
the requirements in a way that was less
stringent than the federal requirements
in this rule.
VIII. Statutory and Executive Order
(E.O.) Reviews
A. Executive Order 12866: Regulatory
Planning and Review & Executive Order
13563: Improving Regulation and
Regulatory Review
This action is a significant regulatory
action that was submitted to the Office
of Management and Budget (OMB) for
review. This rule has been determined
significant because it raises novel legal
or policy issues arising out of a legal
mandate, the President’s priorities or
the principles set forth in the Executive
Order. Any changes made in response to
OMB recommendations have been
documented in the docket. The EPA
prepared an economic analysis of the
potential costs and benefits associated
with this action. This analysis,
‘‘Economic Assessment of the Safe
Management of Recalled Airbags Rule’’,
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is available in the docket. This analysis
estimates the impacts of the rule relative
to two separate baseline scenarios. The
first baseline scenario assumes that all
aspects of the Preservation Order
established between Takata and the
Department of Transportation in
February 2015 and amended in April
2018 will remain in effect until the
completion of the recall process. The
alternative baseline scenario assumes
the removal of the Preservation Order
provisions that allow dealerships to
disregard the volume of recalled airbag
inflators when determining their
hazardous waste generator status (e.g.,
LQG) under RCRA. For each baseline
and for the rule, EPA created a monthly
schedule in order to estimate the
number of airbag inflators shipped,
accumulated, and disposed of by
affected entities. EPA then assigned unit
costs for storage, transport,
management, and disposal of airbag
inflators for each scenario to estimate
the cost savings associated with this
regulation. The cost impacts of the rule
were then calculated as the difference
between post-rule costs and costs under
each baseline scenario. In summary, this
regulatory action is expected to result in
a total cost savings between $7.6 million
and $56.9. million for the duration of
the Takata recalls, resulting in an
estimated annual cost savings of $1.7
million to $13.0 million per year
(discounted at 7%).
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B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
This action is considered an
Executive Order 13771 deregulatory
action. Details on the estimated cost
savings of this final rule can be found
in EPA’s analysis of the potential costs
and benefits associated with this action.
C. Paperwork Reduction Act (PRA)
The information collection activities
in this rule have been granted
emergency approval by the Office of
Management and Budget (OMB) under
the PRA. The Information Collection
Request (ICR) that has been approved by
OMB was assigned EPA ICR number
2589.02 and OMB Control Number
2050–0221. You can find a copy of the
ICR in the docket for this rule, and it is
briefly summarized here.
The collection of information is
necessary in order to ensure that the
hazardous waste airbag modules and
airbag inflators exempted under this
rule are safely disposed of and that
defective airbag modules and airbag
inflators are not reinserted into vehicles
where they would pose an unreasonable
risk of death or serious injury.
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Information collection activities include
requiring affected entities maintain
copies of shipping records and
confirmations of receipt for three years.
In addition to the emergency ICR
which will implement the requirements
for up to six months, EPA is also
developing an ICR based on comments
received on this rulemaking. Towards
this goal, pursuant to section
3506(c)(2)(A) of the PRA, EPA is
soliciting comments and information to
enable it to: (i) Evaluate whether the
collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information will have
practical utility; (ii) evaluate the
accuracy of the Agency’s estimate of the
burden of the collection of information,
including the validity of the
methodology and assumptions used;
(iii) enhance the quality, utility, and
clarity of the information to be
collected; and (iv) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses. EPA will consider the
comments received and amend the ICR
as appropriate.
Respondents/affected entities: The
respondents will primarily be composed
of automobile dealerships. These
dealerships fall under NAICS code 441:
Motor Vehicle and Parts Dealers.
Respondent’s obligation to respond:
The recordkeeping requirements for the
interim final rule consist of maintaining
at the airbag handler for no less than
three years records of (1) all off-site
shipments and (2) confirmations of
receipt of airbag waste. The
recordkeeping requirements may be
fulfilled by ordinary business records,
such as bills of lading, and are intended
to allow the Agency to verify that the
airbag waste reaches its intended
destination and is not diverted back into
vehicles. The statutory authority to
require the recordkeeping activities
derives from sections 2002, 3001, 3002,
3003, 3004, 3006, 3010, and 3017 of the
Solid Waste Disposal Act of 1965, as
amended by the Resource Conservation
and Recovery Act of 1976 (RCRA), as
amended by the Hazardous and Solid
Waste Amendments of 1984 (HSWA).
Estimated number of respondents:
EPA estimates that there will be 15,256
respondents per year.
Frequency of response: EPA estimates
that average facility will make 3 relevant
shipments per year over a 5-year period.
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61561
The facilities must retain
documentation for each shipment.
Total estimated burden: 4,200 hours
(per year). Burden is defined at 5 CFR
1320.3(b).
Total estimated cost: $130,791 (per
year), includes $0 annualized capital or
operation & maintenance costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for the EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
OMB approves this ICR, the Agency will
announce that approval in the Federal
Register and publish a technical
amendment to 40 CFR part 9 to display
the OMB control number for the
approved information collection
activities contained in this final rule.
D. Regulatory Flexibility Act
This action is not subject to the RFA.
The RFA applies only to rules subject to
notice and comment rulemaking
requirements under the Administrative
Procedure Act (APA), 5 U.S.C. 553, or
any other statute. The APA exempts
from notice and comment requirements
rules for which an Agency finds ‘‘for
good cause’’ that notice and an
opportunity to comment are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ The Agency is
invoking this exemption to address
exigent public health issues associated
with the Takata airbag recalls.
E. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more 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.
F. 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.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175. This action does not have
substantial direct effects on one or more
Indian tribes, on the relationship
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between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
H. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
Section 5–502 of Executive Order
13045 provides that in emergency
situations, or where the Agency is
required by law to act more quickly than
normal review procedures allow, the
Agency shall comply with the Executive
Order to the extent practicable. This
action is being issued under a good
cause exemption of notice and comment
rulemaking under the APA to address
an emergency situation associated with
defective airbag inflators and risks to
public health. The rule will remove
potential regulatory impediments
associated with the Takata airbag
recalls. The recalls address explosion
risks associated with faulty airbag
deployment which could cause (and
have caused) serious harm to passengers
in vehicles, including children.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant
energy action’’ because it is not likely to
have a significant adverse effect on the
supply, distribution, or use of energy.
This rulemaking simply removes
potential regulatory impediments
associated with the Takata airbag
recalls; therefore, by itself, this
rulemaking will not have any effect on
the supply, distribution or use of
energy.
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J. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve
technical standards.
16:03 Nov 29, 2018
Jkt 247001
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. The CRA allows the issuing
agency to make a rule effective sooner
than otherwise provided by the CRA if
the agency makes a good cause finding
that notice and comment rulemaking
procedures are impracticable,
unnecessary or contrary to the public
interest (5 U.S.C. 808(2)). The EPA has
made a good cause finding for this rule
as discussed in Section I.B. of this
preamble, including the basis for that
finding.
List of Subjects
40 CFR Part 260
Environmental protection,
Administrative practice and procedure,
Definitions, Hazardous waste.
40 CFR Part 261
Environmental protection, Hazardous
waste, Recycling, Solid waste.
40 CFR Part 262
Environmental protection, Hazardous
waste, Generator Standards.
Dated: November 13, 2018.
Andrew Wheeler,
Acting 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
1. The authority citation for part 260
continues to read as follows:
■
Subpart B—Definitions
2. Section 260.10 is amended by
adding in alphabetical order definitions
for ‘‘Airbag waste’’, ‘‘Airbag waste
collection facility’’, and ‘‘Airbag waste
handler’’ to read as follows:
■
§ 260.10
Definitions
*
*
*
*
*
Airbag waste means any hazardous
waste airbag modules or hazardous
waste airbag inflators.
Airbag waste collection facility means
any facility that receives airbag waste
from airbag handlers subject to
regulation under § 261.4(j) of this
chapter, and accumulates the waste for
more than ten days.
Airbag waste handler means any
person, by site, who generates airbag
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waste that is subject to regulation under
this chapter.
*
*
*
*
*
PART 261—IDENTIFICATION AND
LISTING OF HAZARDOUS WASTE
3. The authority citation for Part 261
continues to read as follows:
■
Authority: 42 U.S.C. 6905, 6912(a), 6921,
6922, 6924(y) and 6938.
Subpart A—General
4. Section 261.4 is amended by adding
reserved paragraph (i) and adding
paragraph (j) to read as follows:
■
§ 261.4
Exclusions.
*
Authority: 42 U.S.C. 6905, 6912(a), 6921–
6927, 6930, 6935, 6937, 6938, 6939 and 6974.
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes that this action is
not subject to Executive Order 12898 (59
FR 7629, February 16, 1994) because the
rule increases protection of human
health and the environment by
removing potential regulatory
impediments associated with the Takata
airbag recalls while ensuring safe
management and disposal of airbag
waste. The recalls address explosion
risks associated with faulty airbag
deployment which could cause (and
have caused) serious harm to
passengers, including passengers from
minority and low-income communities.
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M. Congressional Review Act
Sfmt 4700
*
*
*
*
(j) Airbag waste. (1) Airbag waste at
the airbag waste handler or during
transport to an airbag waste collection
facility or designated facility is not
subject to regulation under parts 262
through 268, part 270, or part 124 of this
chapter, and is not subject to the
notification requirements of section
3010 of RCRA provided that:
(i) The airbag waste is accumulated in
a quantity of no more than 250 airbag
modules or airbag inflators, for no
longer than 180 days;
(ii) The airbag waste is packaged in a
container designed to address the risk
posed by the airbag waste and labeled
‘‘Airbag Waste–Do Not Reuse’’;
(iii) The airbag waste is sent directly
to either:
(A) An airbag waste collection facility
in the United States under the control
of a vehicle manufacturer or their
authorized representative, or under the
control of an authorized party
administering a remedy program in
response to a recall under the National
Highway Traffic Safety Administration,
or
(B) A designated facility as defined in
40 CFR 260.10;
(iv) The transport of the airbag waste
complies with all applicable U.S.
Department of Transportation
regulations in 49 CFR part 171 through
180 during transit;
(v) The airbag waste handler
maintains at the handler facility for no
less than three (3) years records of all
off-site shipments of airbag waste and
all confirmations of receipt from the
receiving facility. For each shipment,
these records must, at a minimum,
contain the name of the transporter and
date of the shipment; name and address
of receiving facility; and the type and
quantity of airbag waste (i.e., airbag
modules or airbag inflators) in the
shipment. Confirmations of receipt must
include the name and address of the
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receiving facility; the type and quantity
of the airbag waste (i.e., airbag modules
and airbag inflators) received; and the
date which it was received. Shipping
records and confirmations of receipt
must be made available for inspection
and may be satisfied by routine business
records (e.g., electronic or paper
financial records, bills of lading, copies
of DOT shipping papers, or electronic
confirmations of receipt).
(2) Once the airbag waste arrives at an
airbag waste collection facility or
designated facility, it becomes subject to
all applicable hazardous waste
regulations, and the facility receiving
airbag waste is considered the
hazardous waste generator for the
purposes of the hazardous waste
regulations and must comply with the
requirements of 40 CFR part 262.
(3) Reuse in vehicles of defective
airbag modules or defective airbag
inflators subject to a recall under the
National Highway Traffic Safety
Administration is considered sham
recycling and prohibited under 40 CFR
261.2(g).
PART 262—STANDARDS APPLICABLE
TO GENERATORS OF HAZARDOUS
WASTE
5. The authority citation for part 262
continues to read as follows:
■
Authority: 42 U.S.C. 6906, 6912, 6922–
6925, 6937, 6938 and 6939g.
Subpart A—General
6. Section 262.14 is amended by
revising paragraphs (a) introductory text
and (a)(5) to read as follows:
■
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§ 262.14 Conditions for exemption for a
very small quantity generator.
(a) Provided that the very small
quantity generator meets all the
conditions for exemption listed in this
section, hazardous waste generated by
the very small quantity generator is not
subject to the requirements of parts 124,
262 (except §§ 262.10 through 262.14)
through 268, and 270 of this chapter,
and the notification requirements of
section 3010 of RCRA and the very
small quantity generator may
accumulate hazardous waste on site
without complying with such
requirements. The conditions for
exemption are as follows:
*
*
*
*
*
(5) A very small quantity generator
that accumulates hazardous waste in
amounts less than or equal to the limits
in paragraphs (a)(3) and (4) of this
section must either treat or dispose of its
hazardous waste in an on-site facility or
ensure delivery to an off-site treatment,
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16:03 Nov 29, 2018
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storage, or disposal facility, either of
which, if located in the U.S., is:
(i) Permitted under part 270 of this
chapter;
(ii) In interim status under parts 265
and 270 of this chapter;
(iii) Authorized to manage hazardous
waste by a state with a hazardous waste
management program approved under
part 271 of this chapter;
(iv) Permitted, licensed, or registered
by a state to manage municipal solid
waste and, if managed in a municipal
solid waste landfill is subject to part 258
of this chapter;
(v) Permitted, licensed, or registered
by a state to manage non-municipal
non-hazardous waste and, if managed in
a non-municipal non-hazardous waste
disposal unit, is subject to the
requirements in §§ 257.5 through 257.30
of this chapter;
(vi) A facility which:
(A) Beneficially uses or reuses, or
legitimately recycles or reclaims its
waste; or
(B) Treats its waste prior to beneficial
use or reuse, or legitimate recycling or
reclamation;
(vii) For universal waste managed
under part 273 of this chapter, a
universal waste handler or destination
facility subject to the requirements of
part 273 of this chapter;
(viii) A large quantity generator under
the control of the same person as the
very small quantity generator, provided
the following conditions are met:
(A) The very small quantity generator
and the large quantity generator are
under the control of the same person as
defined in § 260.10 of this chapter.
‘‘Control,’’ for the purposes of this
section, means the power to direct the
policies of the generator, whether by the
ownership of stock, voting rights, or
otherwise, except that contractors who
operate generator facilities on behalf of
a different person as defined in § 260.10
of this chapter shall not be deemed to
‘‘control’’ such generators.
(B) The very small quantity generator
marks its container(s) of hazardous
waste with:
(1) The words ‘‘Hazardous Waste’’;
and
(2) An indication of the hazards of the
contents (examples include, but are not
limited to, the applicable hazardous
waste characteristic(s) (i.e., ignitable,
corrosive, reactive, toxic); hazard
communication consistent with the
Department of Transportation
requirements at 49 CFR part 172 subpart
E (labeling) or subpart F (placarding); a
hazard statement or pictogram
consistent with the Occupational Safety
and Health Administration Hazard
Communication Standard at 29 CFR
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61563
1910.1200; or a chemical hazard label
consistent with the National Fire
Protection Association code 704);
(ix)–(x) [Reserved]
(xi) For airbag waste, an airbag waste
collection facility or a designated
facility subject to the requirements of
§ 261.4(j) of this chapter.
*
*
*
*
*
[FR Doc. 2018–25892 Filed 11–29–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 10
RIN 0906–AB19
340B Drug Pricing Program Ceiling
Price and Manufacturer Civil Monetary
Penalties Regulation
Health Resources and Services
Administration, HHS.
ACTION: Final rule; effective date change.
AGENCY:
The Health Resources and
Services Administration (HRSA)
administers section 340B of the Public
Health Service Act (PHSA), which is
referred to as the ‘‘340B Drug Pricing
Program’’ or the ‘‘340B Program.’’ HHS
published a final rule on January 5,
2017, that set forth the calculation of the
340B ceiling price and application of
civil monetary penalties. On June 5,
2018, HHS published a final rule that
delayed the effective date of the 340B
ceiling price and civil monetary rule
until July 1, 2019, to consider
alternative and supplemental regulatory
provisions and to allow for sufficient
time for additional rulemaking. On
November 2, 2018, HHS issued a
proposed rule to solicit comments to
change the effective date from July 1,
2019, to January 1, 2019, and to cease
any further delay of the rule. HHS
proposed this action because it
determined that the January 5, 2017,
final rule has been subject to extensive
public comment, and had been delayed
several times. HHS has considered the
full range of comments on the
substantive issues in the January 5,
2017, final rule. After consideration of
the comments received on the effective
date of the proposed rule, HHS is
changing the effective date of the
January 5, 2017, final rule, to January 1,
2019.
DATES: The effective date of the final
rule published in the Federal Register
on January 5, 2017, at 82 FR 1210, and
delayed March 6, 2017 at 82 FR 12508,
March 20, 2017 at 82 FR 14332, May 19,
2017 at 82 FR 22893, September 29,
SUMMARY:
E:\FR\FM\30NOR1.SGM
30NOR1
Agencies
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Rules and Regulations]
[Pages 61552-61563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25892]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 260, 261, and 262
[EPA-HQ-OLEM-2018-0646; FRL9986-91-OLEM]
Safe Management of Recalled Airbags
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule with request for comments.
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SUMMARY: The Environmental Protection Agency (EPA) is issuing this
interim final rule in response to the urgent public health issue posed
by recalled Takata airbag inflators still installed in vehicles. With
this rule, EPA is facilitating a more expedited removal of defective
Takata airbag inflators from vehicles by dealerships, salvage yards and
other locations for safe and environmentally sound disposal by
exempting the collection of airbag waste
[[Page 61553]]
from hazardous waste requirements so long as certain conditions are
met. The Agency is also seeking comment on this interim final rule.
DATES: This interim final rule is effective on November 30, 2018.
Comments must be received on or before January 29, 2019. Under the
Paperwork Reduction Act (PRA), comments on the information collection
provisions must be received on or before January 29, 2019.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OLEM-2018-0646, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: Office of Resource Conservation and
Recovery, Materials Recovery and Waste Management Division, MC 5304P,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460, Tracy Atagi, at (703) 308-8672, ([email protected]).
SUPPLEMENTARY INFORMATION:
Preamble Outline
I. General Information
II. Statutory Authority
III. When will this interim final rule be effective?
IV. Background Information
A. Regulation of Airbag Modules and Airbag Inflators Under RCRA
B. Background on the Takata Inflator Recalls
C. Damage Incidents Related to Airbag Inflator Recycling
D. Impact of Takata Bankruptcy and the Amended Preservation
Order on Management of Takata Inflators
V. Rationale for Conditional Exemption for Collection of Airbag
Waste
VI. Summary of Requirements of the Conditional Exemption for
Collection of Airbag Waste
A. Applicability of Conditional Exemption
B. Limits on Accumulation Times and Quantities at Airbag Waste
Handlers
C. Packaging, Labeling and Transportation Requirements for
Airbag Waste Handlers
D. Tracking and Recordkeeping Requirements for Airbag Waste
Handlers
E. Prohibition on Reuse of Defective Airbag Modules and Airbag
Inflators
VII. State Authorization
VIII. Statutory and Executive Order (E.O.) Reviews
I. General Information
A. Does this action apply to me?
This action applies to entities that manage airbag waste (i.e.,
discarded airbag modules and airbag inflators) that are subject to
hazardous waste regulations. The dealerships performing the Takata
recall work constitute the majority of the facilities that will be
impacted by this rule. These dealerships fall under NAICS code 441:
Motor Vehicle and Parts Dealers. EPA estimates that about 15,256
dealerships may be affected by this rule. Other potentially affected
entities include those in NAICS code 336: Transportation Equipment
Manufacturing, and in NAICS code 562: Waste Management and Remediation
Services.
B. Why is EPA issuing an interim final rule?
Section 553(b)(B) of the Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good cause finds that
notice and public procedures are impracticable, unnecessary or contrary
to the public interest, the agency may issue a rule without providing
notice and an opportunity for public comment. EPA has determined that
there is good cause for issuing this interim final rule without prior
proposal and opportunity for comment because such notice and
opportunity for comment would be impracticable and contrary to the
public interest. Specifically, prompt promulgation of this rule without
delay is necessary to protect human health and the environment by
facilitating the urgent removal of dangerously defective Takata airbag
inflators from vehicles, and by preventing defective Takata airbag
inflators from scrap vehicles from being reused, while maintaining
protection of human health and the environment during airbag waste
collection, storage and disposal.
In its November 3, 2015 Coordinated Remedy Order, the U.S.
Department of Transportation (DOT) National Highway Traffic Safety
Administration (NHTSA) found that it was imperative to accelerate the
rate of the recalls because ``[e]ach airbag inflator with the capacity
to rupture, as the recalled Takata inflators do, presents an
unreasonable risk of serious injury or death . . . Since the propensity
for rupture increases with the age of the inflator, and increases even
more when the vehicle has been exposed to consistent long-term HAH
[high absolute humidity] conditions, the risk for injurious or lethal
rupture increases with each passing day.'' \1\ This report emphasizes
that as the inflators get older, each day that passes brings forth an
increased danger. In addition, as noted in a November 15, 2017 report
prepared by the Independent Monitor for the Takata Restructuring on The
State of the Takata Recalls, ``[t]he words `grenade' and `ticking time
bomb' accurately convey the lethal potential of these defective
inflators.'' \2\
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\1\ National Highway Traffic Safety Administration (NHTSA),
Coordinated Remedy Order, November 3, 2015, Docket No. NHTSA-2015-
0055, paragraph 32. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/nhtsa-coordinatedremedyorder-takata.pdf.
\2\ The Independent Monitor of Takata and the Coordinated Remedy
Program, The State of the Takata Airbag Recalls, November 15, 2017,
page 1, paragraph 1. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/the_state_of_the_takata_airbag_recalls-report_of_the_independent_monitor_112217_v3_tag.pdf.
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Delaying promulgation of this rule through notice and comment
procedures would be impracticable and contrary to the public interest
because such a delay would further increase the risk of death or
serious injury by slowing down the removal of defective Takata airbag
inflators from vehicles and impeding the collection of defective airbag
inflators from salvage yards and other locations (and increasing the
potential for defective airbag inflators in scrap vehicles to be
reused). This existing risk has now increased significantly since the
date of the 2015 NHTSA report because of recent events that further
heighten the urgency to accelerate the recall.
First, more time has passed since the date of the 2015 NHTSA study,
and as noted in that study and reiterated in the 2017 study by the
Independent Monitor, each passing day brings forth more danger. The
danger is greater today than in 2015 because of the increased age of
the inflators.
Second, with the recent amendment to DOT's Preservation Order on
April 12, 2018, and with Takata's restructuring due to bankruptcy
finalized on February 21, 2018, vehicle manufacturers no longer have to
send recalled inflators to Takata warehouses
[[Page 61554]]
for long-term storage but may now send them directly for disposal. EPA
is encouraging this through today's conditional exemption, since long-
term storage of recalled inflators can make the defect more dangerous.
These recalled inflators that are sent directly to disposal are not
covered by the amended Preservation Order and thus are regulated as
hazardous waste, whereas in the past they were not regulated as waste
under the original Preservation Order. As a result, many automobile
dealers and other entities who continue to replace recalled airbag
inflators at the current rate of repair could become subject to
additional hazardous waste generator requirements in 40 CFR part 262,
which would impose additional regulatory obligations on the dealers'
and salvage vendors' management of the inflators. Through our
conversations with DOT, the automobile manufacturers, automotive
salvage vendors, and other affected stakeholders, EPA has learned that
imposing full generator requirements on automobile dealers and salvage
vendors who lack the expertise and experience in managing hazardous
waste would result in the slowdown, rather than the necessary
acceleration, of the recall effort, resulting in even greater harm to
human health and the environment.\3\
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\3\ EPA 2018. Compilation of Stakeholder Meeting Summaries
Regarding RCRA Regulation of Airbag Waste.
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This rule is intended to assist the automobile dealers and other
entities in their handling of the airbags, and ensure delivery of the
airbags to facilities that can more expertly manage these airbags in
order to accelerate the recall. Thus, it is essential that there be no
delay in promulgating this rule.
Third, there have continued to be deaths as recently as 2018 as a
result of Takata airbag explosions. On January 1, 2018, there was a
death in Malaysia \4\, and before that, on July 13, 2017, a death in
Australia \5\ as well as another on July 19, 2017 in Florida \6\ as a
result of defective Takata airbags.
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\4\ Confirmed Rupture of Takata Driver's Airbag Inflator in
Malaysia on January 1, 2018 (Jan. 30, 2018), https://www.honda.com.my/corporate/press_release_details/660/Confirmed-Rupture-of-Takata-Driver%E2%80%99s-Airbag-Inflator-in-Malaysia-on-January-1,-2018.
\5\ Takata Recall: Sydney man was due to replace airbag two days
before fatal accident (last updated Sept. 6, 2018), https://www.theguardian.com/world/2018/sep/07/takata-recall-sydney-man-was-due-to-replace-airbag-two-days-before-fatal-accident.
\6\ 20th death from faulty Takata airbags reported by Honda
(Dec. 20, 2017), https://www.cbsnews.com/news/20th-death-from-faulty-takata-air-bags-reported-by-honda/.
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Finally, with respect to the effective date, EPA finds that it has
good cause to make the revisions immediately effective under section
553(d) of the Administrative Procedure Act (APA), 5 U.S.C. 553(d), and
section 3010(b) of RCRA, 42 U.S.C. 6930(b). Section 553(d) provides in
pertinent part that final rules shall not become effective until 30
days after publication in the Federal Register, ``except . . . a
substantive rule which grants or recognizes an exemption or relieves a
restriction . . . or as otherwise provided by the agency for good
cause''. RCRA section 3010(b) has similar provisions for an immediate
effective date. It provides for an immediate effective date, rather
than the usual six month period, for ``(1) a regulation with which the
Administrator finds the regulated community does not need six months to
come into compliance . . . . or (3) other good cause found and
published with the regulation,'' among other exceptions.
The purpose of section 553(d) of the APA is to ``give affected
parties a reasonable time to adjust their behavior before the final
rule takes effect.'' Omnipoint Corp. v. FCC, 78 F.3d 620, 630 (D.C.
Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104
(8th Cir. 1977) (quoting legislative history). Similarly, as noted
above, whether the regulated community needs a period of time to come
into compliance is relevant to the application of RCRA section 3010(b).
Because this rule grants a conditional exemption from certain RCRA
hazardous waste requirements, it qualifies for the APA exemption for
any rule that ``recognizes or grants an exemption or relieves a
restriction'' as well as the RCRA exemption for any rule for which
``the regulated community does not need six months to come into
compliance.''
Moreover, EPA has determined that for purposes of both the APA and
RCRA effective date provisions, there is good cause for making this
final rule effective immediately. In determining whether good cause
exists to waive the 30-day effective date under the APA, an agency
should ``balance the necessity for immediate implementation against
principles of fundamental fairness which require that all affected
persons be afforded a reasonable amount of time to prepare for the
effective date of its ruling.'' Gavrilovic, 551 F.2d at 1105. EPA has
also applied this balancing test to the RCRA effective date provision
for purposes of this rule. This rule facilitates a more expedited
removal of defective Takata airbag inflators from vehicles by
dealerships, salvage yards and other locations for safe and
environmentally sound disposal by exempting the collection of airbag
waste from hazardous waste requirements so long as certain conditions
are met. Because this action provides an exemption to certain
requirements that automobile dealers and other parties would otherwise
need to follow under RCRA, and because this exemption is optional, the
regulated community does not need time to prepare for this rule.
Specifically, as further discussed in this preamble, the conditions for
the exemption mirror how recalled airbag modules and airbag inflators
have been managed under the DOT Preservation Order during the past
three years, and therefore no additional time is needed to start
operating under the exemption. In contrast, the necessity of immediate
implementation is great, as previously discussed.
As a result, EPA is making this interim final rule effective upon
publication.
II. Statutory Authority
These regulations are promulgated under the authority of sections
2002, 3001, 3002, 3003, 3004, 3006, 3010, and 3017 of the Solid Waste
Disposal Act of 1965, as amended by the Resource Conservation and
Recovery Act of 1976 (RCRA), as amended by the Hazardous and Solid
Waste Amendments of 1984 (HSWA). This statute is commonly referred to
as ``RCRA.''
III. When will this interim final rule be effective?
The revisions to 40 CFR 260.10, CFR 261.4 and CFR 262.14 become
effective on November 30, 2018.
IV. Background Information
A. Regulation of Airbag Modules and Airbag Inflators Under RCRA
An airbag module is a fully assembled unit including both the
airbag inflator and the fabric cushion. An airbag inflator is the small
metal canister within the airbag module that generally houses explosive
propellant and an initiator. The airbag module is deployed when the
airbag inflator receives an electronic pulse from a vehicle's crash
sensor. In properly functioning airbag modules that use a gas
generating system, chemical propellant contained in an airbag inflator
unit burns in a fast and controlled manner, quickly emitting an inert
gas through vents in the canister out into the airbag module, which
inflates the cushion. Airbag modules across the automobile safety
industry utilize explosive propellants for rapid response to an
automobile accident.
Most airbag inflators use oxidizers as part of the gas generating
composition of
[[Page 61555]]
the propellant and, therefore, when discarded, would meet the
definition of ignitable hazardous waste under the RCRA hazardous waste
regulations at 40 CFR 261.21(a)(4), which states that a solid waste
exhibits the characteristic of ignitability if, ``[i]t is an
oxidizer.'' \7\ In addition, due to the explosive propellant component,
discarded airbag modules and airbag inflators meet the definition of
reactive hazardous waste at 40 CFR 261.23(a)(6), which states that a
solid waste exhibits the characteristic of reactivity if, ``[i]t is
readily capable of detonation or explosive reaction if it is subjected
to a strong initiating source or if heated under confinement.'' \8\ The
deployment of airbag inflators generally results in the depletion of
the ignitable and/or reactive components to cause the release of inert
gas, after which the inflators would no longer exhibit the ignitable or
reactive characteristics under the RCRA regulations.
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\7\ Ignitable hazardous waste carries the waste code D001.
\8\ Reactive hazardous waste carries the waste code D003.
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Airbag modules and airbag inflators that exhibit hazardous waste
characteristics under 40 CFR part 261 subpart C may be exempt from
hazardous waste regulations under certain scenarios, as summarized in
an EPA memorandum signed on July 19, 2018.\9\ As the memo explains, the
applicable RCRA hazardous waste regulations for airbag modules and
airbag inflators depend on the type of device, and how it is managed.
However, it is important to note that, as the memo explains, recalled
Takata airbag modules and airbag inflators removed from vehicles do not
qualify for the exemptions and exclusions available to non-recalled
airbag modules and airbag inflators because, as described in this
preamble, the Takata recalled airbag inflators cannot be safely reused
or deployed.
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\9\ U.S. EPA, Regulatory Status of Automotive Airbag Inflators
and Fully Assembled Airbag Modules, July 19, 2018.
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B. Background on the Takata Inflator Recalls
In May 2015, the U.S. Department of Transportation (DOT) announced
a national recall of airbag inflators manufactured by Takata due to a
defect in their phase-stabilized ammonium nitrate (PSAN) propellant,
which has resulted in fifteen deaths and at least 250 injuries in the
U.S. as of August 2018.\10\ These airbag inflator recalls constitute
the largest automotive recall in U.S. history, with 19 vehicle
manufacturers affected and approximately 65-70 million airbag inflators
scheduled to be recalled by December 2019. Of these affected airbag
inflators, 50 million inflators in an estimated 37 million vehicles
were recalled as of August 2018 and the remaining inflators will be
recalled by December 2019.\11\ Included in this number are tens of
thousands of ``Alpha'' airbag inflators, which have a significantly
higher risk of rupture due to a manufacturing defect resulting in low-
density propellant in addition to the propellant defect described
below. Nine of the 15 fatalities in the U.S. were caused by Alpha
airbag inflators.\12\
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\10\ National Highway Traffic Safety Administration (NHTSA),
Takata Recall Spotlight. https://www.nhtsa.gov/equipment/takata-recall-spotlight.
\11\ Id.; National Highway Traffic Safety Administration
(NHTSA), The State of Takata Recalls, https://www.nhtsa.gov/recall-spotlight/state-takata-recalls.
\12\ National Highway Traffic Safety Administration (NHTSA),
Takata ``Alpha'' Airbags Pose Increased Risk, https://www.nhtsa.gov/recalls/takata-alpha-air-bags-pose-increased-risk.
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On November 3, 2015, the National Highway Traffic Safety
Administration (NHTSA) issued a Coordinated Remedy Order that set forth
the requirements and obligations of certain motor vehicle manufacturers
and the airbag manufacturer, Takata, in connection with the recall and
remedy of certain types of Takata airbag inflators.\13\ In its
Coordinated Remedy Order, NHTSA found that it was imperative to
accelerate the rate of the recalls because ``[e]ach airbag inflator
with the capacity to rupture, as the recalled Takata inflators do,
presents an unreasonable risk of serious injury or death. . . . Since
the propensity for rupture increases with the age of the inflator, and
increases even more when the vehicle has been exposed to consistent
long-term HAH [high absolute humidity] conditions, the risk for
injurious or lethal rupture increases with each passing day.'' \14\
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\13\ National Highway Traffic Safety Administration (NHTSA),
Coordinated Remedy Order, November 3, 2015, Docket No. NHTSA-2015-
0055. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/nhtsa-coordinatedremedyorder-takata.pdf.
\14\ Ibid, paragraph 32.
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The PSAN propellant used in the recalled Takata airbag inflators
degrades over time when moist propellant is exposed to long-term daily
temperature cycling. Moisture from the air adsorbs to PSAN particles,
changing the structure of the propellant and causing the inflator to
over-pressurize during deployment.\15\ In some cases, this over-
pressurization causes the metal canister to rupture, producing
shrapnel-like metal shards during airbag inflation. To mitigate these
effects, Takata began manufacturing PSAN airbag inflators containing
desiccant to prevent the adsorption of moisture to the PSAN particles.
While some inflators with desiccant have been recalled, others are
still under evaluation and may or may not be recalled in the
future.\16\
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\15\ National Highway Traffic Safety Administration (NHTSA),
Expert Report of Harold R. Blomquist, Ph.D., May 4, 2016. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/expert_report-hrblomquist.pdf.
\16\ National Highway Traffic Safety Administration (NHTSA), New
Takata recall involves Nissan, Ford, and Mazda vehicles, https://www.nhtsa.gov/recall-spotlight/new-takata-recall-involves-nissan-ford-and-mazda-vehicles.
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A 2015 Safety Data Sheet (SDS) for Takata pyrotechnic automotive
safety devices, including airbag modules and airbag inflators,
describes the hazards of the devices, including an ``[i]nitiation
hazard of an uncontrolled activation of the safety device due to: Fire;
heat; electrostatic discharge; inductions through electromagnetic
radiation; or, excessive mechanical load'' and a ``[b]urn hazard when
there is direct contact with pyrotechnic safety device during
activations.'' \17\ The firefighting measures described in the SDS
include evacuating personnel and emergency responders for 1500 feet
(\1/3\ mile). In the event of spilled material from damaged devices,
the SDS recommends that an explosive expert conduct the cleanup using
anti-static equipment.
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\17\ Takata Safety Data Sheet (SDS)--Pyrotechnic Automotive
Safety Devices, January 2015.
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Propagation and bonfire testing results submitted to EPA by Takata
provides further information regarding the hazards posed by recalled
Takata inflators.\18\ In September 2016, a third-party company
performed sympathetic propagation testing on two types of recalled
Takata airbag inflators for Takata. The testing generally consisted of
bundling several inflators together and deploying the center inflator
in order to observe the effects of deployment on the surrounding
inflators. The results of the testing showed that deployment of one
inflator does not cause deployment of surrounding inflators. In some
tests, the center inflator fragmented, but it still did not cause
surrounding inflators to deploy or fragment, although some superficial
damage to the surrounding inflators did occur. In April 2017, a third-
party company performed the UN 6(c) external fire (bonfire) test on
recalled Takata airbag inflators in individual fiberboard boxes. The
inflators did not mass detonate when exposed to fire, but they did
initiate, as
[[Page 61556]]
would be expected when inflators are exposed to temperatures generated
by this type of fire. In some cases, they were propelled from their
initial locations of rupture, throwing fragments beyond the initial
location of the inflator.
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\18\ Testing information was submitted as confidential business
information (CBI). The summary of results in this preamble does not
contain CBI.
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C. Damage Incidents Related to Airbag Inflator Recycling
While non-Takata airbag inflators do not present the same shrapnel-
producing defect as recalled Takata airbag inflators, these airbag
inflators can still present an explosive risk when processed or
recycled, as demonstrated by recent incidents at two facilities. In
February 2015, an explosion and fire occurred at one airbag
manufacturing and recycling facility as two workers handled airbag
inflators that had been processed in an incinerator prior to recycling
the metal.\19\ In that incident, one worker was hospitalized with head
injuries and burns. In March 2018, a large explosion at a different
airbag recycling facility in the dedicated airbag recycling area killed
one worker and seriously injured another.\20\ This explosion is
suspected to have been caused by the ignition of aluminum dust, which
was created in the process of shredding airbag inflators. These
incidents demonstrate the characteristically hazardous nature of waste
airbag inflators and their component materials and the potential risk
they pose to human health during processing.
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\19\ U.S. EPA, Autoliv Promontory Facility (20 June 2017), July
24, 2018.
\20\ Tennessee Occupational Safety and Health Administration,
Redacted Report: Lighting Resources LLC Explosion on March 14, 2018,
August 16, 2018.
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D. Impact of Takata Bankruptcy and the Amended Preservation Order on
Management of Takata Inflators
2015 Preservation Order
A Preservation Order issued by DOT and signed by Takata in February
2015 required all recalled airbag inflators be preserved intact, except
for those utilized for testing purposes. Takata was required to take
all reasonable and appropriate steps designed to prevent the partial or
full destruction, alteration, deletion, shredding, incineration or loss
of recalled or returned inflators, ruptured inflators and any other
inflators under the recalls. The recalled Takata inflators were
organized into categories of inflators that must be preserved. Ruptured
inflators from field events were required to be preserved in a locked,
secured, climate-controlled area, except for testing, inspection or
analysis purposes. Recalled or returned inflators were also to be kept
in a locked, secured and climate-controlled area.
EPA June Memorandum
In the June 23, 2017 memorandum, EPA clarified that the recalled
Takata airbag inflators are not subject to RCRA Subtitle C regulatory
requirements while they are being held under the 2015 DOT Preservation
Order because EPA does not consider materials being stored pending
judicial proceedings or investigations to be ``discarded.'' This
interpretation is consistent with previous interpretations EPA has
taken on similar materials, such as seized fireworks held as evidence
and materials from aircraft accidents subject to investigation, where
such items would otherwise be considered hazardous
waste.21 22 Additionally, EPA clarified that Takata recalled
airbag inflators would be considered ``used'' (i.e., spent materials),
and therefore a solid waste, once the preservation requirements are
lifted. When the recalled Takata airbag inflators are discarded as a
solid waste, EPA believes that they meet both the ignitability and
reactivity hazardous waste characteristics.\23\
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\21\ U.S. EPA, Explosives Presenting an Immediate Safety Threat
and Explosives Stored During Analysis, August 11, 1988. RCRA Online
11363.
\22\ U.S. EPA, Management of Aircraft Remains from Catastrophic
Loss Events, January 6, 2014. RCRA Online 14881.
\23\ Ignitable waste code D001 (40 CFR 261.21(a)(4)). Reactive
waste code D003 (40 CFR 261.23(a)(6)).
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Impact of Takata Bankruptcy on Recall Procedures
Takata's U.S. subsidiary, TK Holdings Inc., filed for Chapter 11
bankruptcy on June 25, 2017, and received U.S. court approval for its
plan on February 21, 2018.\24\ Takata's manufacturing assets were sold
to Key Safety Systems, another automobile safety system manufacturer,
and the money from the sale was used to settle debts and legal claims.
A small portion of the company emerged from bankruptcy and has a
section dedicated to facilitating the replacement of recalled airbag
inflators.\25\ Takata's plan sets aside funds designated for the
removal, handling and eventual disposal of recalled airbag inflators
received before the effective date of the bankruptcy, April 10, 2018,
and states that Takata will continue to provide replacement airbag
inflators until the recall process is finished, expected in 2020.\26\
Takata will also continue to receive recalled airbag inflators for
storage prior to testing or eventual disposal after April 10, 2018,
although it is not required to do so. EPA's understanding is that
Takata will charge the automobile manufacturers to cover the costs
associated with storage and eventual disposal of these inflators
received after April 10, 2018. These costs include the overhead
expenses associated with Takata managing the collection, storage, and
disposal of airbag inflators, including wages and benefits for their
workers that are involved in handling and coordinating the movement of
the inflators. Prior to the bankruptcy effective date, Takata accepted
and managed these inflators from the affected vehicle manufacturers
free of charge.
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\24\ Prime Clerk, Takata TK Holdings Inc Bankruptcy Case
Information, https://restructuring.primeclerk.com/takata/Home-Index.
\25\ To avoid confusion, the entities responsible for managing
the Takata airbag inflator recalls, including Takata's post-
bankruptcy successor company TK Global, will collectively be
referred to as ``Takata'' in this preamble.
\26\ U.S. Bankruptcy Court--District of Delaware, Fifth Amended
Joint Chapter 11 Plan of Reorganization of TK Holdings Inc. and its
Affiliated Debtors, filed February 20, 2018.
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2018 Amended Preservation Order
The April 12, 2018 Amendment to the February 25, 2015 Preservation
Order and Testing Control Plan, issued by the U.S. DOT's NHTSA,
requires Takata to preserve certain airbag inflators that are the
subject of an ongoing defect investigation by NHTSA and the subject of
private litigation.\27\ The Amendment also requires Takata to implement
a control plan for the inspection, testing, or analysis of those
inflators.
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\27\ National Highway Traffic Safety Administration (NHTSA),
Amendment to the February 25, 2015 Preservation Order and Testing
Order Control Plan, April 12, 2018, EA15-001 (formerly PE14-016).
https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/preservation_order_amendment_public_-_april_12_2018-tag.pdf.
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The original 2015 Preservation Order required Takata to preserve
indefinitely all affected airbag inflators, while the 2018 Amendment
enables Takata to reduce the number of preserved airbag inflators by
requesting the release of certain inflators from the Preservation Order
allowing them to be disposed in compliance with all applicable
regulations, including RCRA. The Amended Order also requires Takata to
account for returned foreign and other ammonium-nitrate containing
inflators. The Amendment applies to Takata airbag inflators removed
from vehicles as a result of recalls affecting the 19 vehicle
manufacturers.
The terms of the Amendment require Takata to track all airbag
inflators in its possession by unique serial number and set aside at
least 5% of inflators,
[[Page 61557]]
proportionate to the overall number of inflators received from each
State and of each type of inflator, for future analysis. The Amendment
allows Takata to submit Disposal Designations to NHTSA, identifying a
specific quantity of inflators to be released from preservation and
disposed. The designated inflators are considered released from the
Preservation Order fifteen business days after NHTSA's confirmation of
receipt of the Disposal Designation.
Although the affected vehicle manufacturers may choose to contract
with Takata's post-bankruptcy reorganized entity to transport and store
recalled airbag inflators, they are not required to do so by the
Preservation Order or Amendment. If a vehicle manufacturer chooses to
contract with the Takata entity, the Takata entity must preserve those
airbag inflators under the terms of the Preservation Order, and
therefore those airbag inflators are not solid wastes per EPA's June
23, 2017 memorandum as described above. However, a vehicle manufacturer
may choose not to contract with the Takata entity for a variety of
reasons, including increased cost, increased liability, and slower
disposal, in which case those airbag inflators would not be covered by
the Preservation Order or Amendment, and would be considered discarded
when removed from the vehicle.
V. Rationale for Conditional Exemption for Collection of Airbag Waste
In its 2015 Coordinated Remedy Order pertaining to the Takata
airbag recalls, DOT found that it was imperative to accelerate the rate
of the recalls because ``[e]ach airbag inflator with the capacity to
rupture, as the recalled Takata inflators do, presents an unreasonable
risk of serious injury or death. . .Since the propensity for rupture
increases with the age of the inflator, and increases even more when
the vehicle has been exposed to consistent long-term HAH [high absolute
humidity] conditions, the risk for injurious or lethal rupture
increases with each passing day.'' \28\
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\28\ National Highway Traffic Safety Administration (NHTSA),
Coordinated Remedy Order, November 3, 2015, Docket No. NHTSA-2015-
0055. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/nhtsa-coordinatedremedyorder-takata.pdf.
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Since the original order was issued by DOT, the affected vehicle
manufacturers have been working steadily to remove the recalled Takata
airbag inflators from vehicles. As discussed earlier, because of DOT's
Preservation Order, the recalled airbag inflators have not been
regulated as hazardous waste and have instead been safely collected,
transported as hazardous materials and stored under the Preservation
Order.
With the amendment to DOT's Preservation Order and with Takata's
restructuring due to bankruptcy, vehicle manufacturers may now dispose
of recalled inflators that are not covered by the amended Preservation
Order directly, rather than sending them to the Takata warehouses for
long-term storage. This approach is preferable from a public health and
environmental protection perspective both because it reduces the volume
of inflators in long-term storage and because it is more efficient in
freeing up resources spent on handling and storage that can be spent
directly on the recalls themselves.
However, because this subset of recalled inflators is not subject
to the DOT Preservation Order, they would be regulated as hazardous
waste. As a result, many automobile dealers and other entities who
continue to replace recalled airbag inflators at the current rate of
repair would become subject to additional hazardous waste generator
requirements in 40 CFR part 262, which would impose additional
regulatory obligations on the dealers' and salvage vendors' management
of the inflators.
Most automobile dealers and salvage vendors are currently in the
category of ``Very Small Quantity Generators'' of hazardous waste. By
managing hazardous airbag waste, the dealers and salvage vendors would
likely generate sufficient amounts of hazardous waste (on a monthly
basis) to become subject to increased regulations associated with
higher generator categories for which dealers and salvage vendors
typically have not had experience, familiarity, or expertise. Imposing
these increased generator obligations on dealers and salvage vendors
would result in a much less efficient, effective and environmentally
protective approach to the urgent, time-critical recall effort. Through
our conversations with DOT, the automobile manufacturers, automotive
salvage vendors, and other affected stakeholders, EPA has learned that
imposing full generator requirements on automobile dealers and salvage
vendors who lack the expertise and experience in managing hazardous
waste might result in the slowdown, rather than the necessary
acceleration, of the recall effort, resulting in greater harm to human
health and the environment.\29\ The automobile manufacturers are
worried that, because of their lack of familiarity and expertise with
full RCRA hazardous waste generator regulations and the additional
costs related to the management of hazardous waste in these higher
generator categories, if the dealers were to become fully regulated
small or large quantity generators due to handling recalled airbag
waste, they may slow down or stop removing recalled airbag inflators
altogether. In addition, some stakeholders have expressed their concern
of a lack of hazardous waste transportation capacity, especially in
more sparsely populated rural areas of the country. As hazardous waste
generators, dealers would be required to use certified hazardous waste
transporters, which are less numerous and more expensive than standard
hazardous material transporters used to transport recalled inflators
under the DOT preservation order. Thus, placing full hazardous waste
generator requirements on dealers or salvage yards would not be the
most efficient or environmentally protective approach for the above
reasons. In contrast, as explained in the following section, an airbag
waste collection facility under the control of a vehicle manufacturer
or their authorized representative or under the control of an
authorized party administering a remedy program in response to the
recalls or a designated facility as defined in 40 CFR 260.10, has
greater expertise and familiarity in properly managing hazardous waste.
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\29\ EPA 2018. Compilation of Stakeholder Meeting Summaries
Regarding RCRA Regulation of Airbag Waste.
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A related but separate issue involves airbag modules and airbag
inflators scavenged from scrapped automobiles. One vendor company has
been involved in the collection of Takata airbag modules from the
approximately 6,000 salvage yards in the United States. The company was
approached by one automobile manufacturer after they discovered a
number of injuries were caused by recalled Takata airbag inflators
recovered from salvage yards and installed in other vehicles. The
salvage vendor worked with the automobile manufacturer, DOT, and the
independent monitor to put together a program to retrieve airbag
modules containing recalled airbag inflators before the inflators can
be removed and placed in another vehicle because at that point, they
are virtually untraceable. The vendor collects the airbag and brings
them to a central location where they undergo a validation step to
determine whether they are definitively recalled airbag inflators. This
validation includes using visual aids and scanning all VIN and serial
numbers. The vendor also supplies specifically designed packaging and
handles the
[[Page 61558]]
transportation for the airbag modules. Once a pallet of validated
airbag modules is collected (approximately 100-110 pieces), the pallet
is sent for disposal and a certificate of destruction is provided. The
airbag modules are transported in compliance with DOT hazardous
materials regulations. According to this vendor, if the airbag modules
must be handled as RCRA hazardous waste when removed from a vehicle in
the salvage yard, the salvage yards would likely stop removing them.
Due to the potential for the replacement of defective Takata airbag
inflators to slow down with the application of full RCRA generator
requirements, EPA has determined that modified RCRA requirements are
appropriate for automobile dealers, salvage yards, and other entities
that are removing the recalled airbag inflators and facilitating the
recalls.
As discussed earlier, any potential delay to the recalls presents
an immediate public health threat, increasing the chances of death or
serious injury due to a defective airbag deploying in a vehicle.
Moreover, the system for managing the recalled airbag modules and
inflators under the DOT Preservation Order over the last three years
has provided for protection of human health and the environment during
collection and transport of the airbag modules and inflators. Under the
recalls, each individual recalled inflator is tracked by vehicle
identification number, and subject to DOT packaging and transportation
regulations. Vehicle manufacturers work with their dealers to make sure
that the recalled inflators are quickly moved offsite and not over-
accumulated, and have a strong incentive from a liability perspective
to continue to do so in the future.
The conditions for the exemption promulgated by this rule mirror
how recalled airbag modules and airbag inflators have been managed
under the DOT Preservation Order during the past three years, except
that instead of going to long-term storage under the Preservation
Order, the collected airbag waste will be sent for safe disposal at a
RCRA facility designated to receive hazardous waste per 40 CFR 260.10.
Thus, exempting the collection of airbag waste from RCRA requirements,
provided certain conditions are met, will result in an increase in
protection of public health by facilitating the recalls, allowing the
current airbag waste collection system to continue to safely collect
the recalled inflators, and sending them directly to appropriate
disposal facilities rather than to long-term storage facilities under
the Preservation Order.
As previously explained in other rulemakings, EPA has authority
under RCRA to issue conditional exclusions from the hazardous waste
regulations. EPA has previously interpreted RCRA section 3001(a) to
authorize the issuance of ``conditional exemptions'' from the
requirements of RCRA Subtitle C, where it determines that ``a waste
might pose a hazard only under limited management scenarios, and other
regulatory programs already address such scenarios.'' 62 FR at 6636
(February 12, 1997); 66 FR at 27222-27223 (May 16, 2001). The final
rule takes a similar approach to those earlier rules.
Section 3001(a) requires that EPA decide whether a waste ``should
be subject to'' the requirements of RCRA Subtitle C. Hence, RCRA
section 3001 authorizes EPA to determine when subtitle C regulation is
appropriate. EPA has consistently interpreted section 3001 of RCRA to
give it broad flexibility in developing criteria for hazardous wastes
to enter or exit the Subtitle C regulatory system.
RCRA section 1004(5) further supports EPA's interpretation. This
interpretation has also been upheld upon judicial review. See, e.g.,
Military Toxics Project v. EPA, 146 F. 3d 948 (DC Cir. 1998) (upholding
conditional exemption for storage of military munitions, based on EPA
determination that such wastes are subject to binding standards that
meet or exceed RCRA standards, in addition to an institutional
oversight process.) EPA has interpreted the statutory definition of
hazardous waste in RCRA section 1004(5)(B) as incorporating the idea
that a waste that is otherwise hazardous does not require regulation
under RCRA so long as it is properly managed.
EPA has most recently provided a full discussion of EPA's authority
for conditional exclusion from RCRA Subtitle C requirements in the
preamble in its final rule entitled Hazardous Waste Management System:
Conditional Exclusion for Carbon Dioxide (CO2) Streams in Geologic
Sequestration Activities, 79 FR 350, 353-354 (January 3, 2014).
Consistent with that rule, and other rules involving conditional
exemptions, EPA has determined in this rule, as discussed above, that
exempting the collection of airbag waste from RCRA requirements,
provided certain conditions are met, will result in an increase in
protection of public health by facilitating the recalls and allowing
the current airbag waste collection system to continue to safely
collect the recalled inflators. It is important to note, however, that
this conditional exemption only applies to the storage and transport of
airbag waste during collection. The final disposition of the hazardous
airbag waste continues to be regulated under applicable RCRA Subtitle C
hazardous waste regulations.
EPA has received requests from stakeholders to unconditionally
exempt airbag modules and inflators from RCRA hazardous waste
regulations.\30\ However, EPA has determined, based on the nature of
the waste and the damage cases that have occurred at airbag recycling
facilities, an exemption for the final disposition of airbag waste
would not be protective of human health and the environment. While the
collection of intact airbag modules and inflators by vehicle
manufacturers or their authorized representatives according to DOT
requirements can be done safely without imposing RCRA requirements
beyond the conditions of the exemption discussed in this preamble,
processing the airbag inflator, which requires treatment of the
ignitable and reactive propellant inside the inflator, is another
matter. As discussed earlier, there have been at least two explosions
at airbag recycling facilities, including one that resulted in a
fatality, and in the case of the recalled Takata airbag inflators, the
degraded nature of the propellant makes the potential for explosive
reactions even worse. The protections provided by a RCRA Subtitle C
hazardous waste permitted facility, including personnel training,
inspections, contingency planning and emergency response, and an
informed community through public participation address the risk of
explosion from the end-of-life management of the collected airbag
waste.
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\30\ EPA 2018. Compilation of Stakeholder Meeting Summaries
Regarding RCRA Regulation of Airbag Waste.
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EPA solicits comment on the conditional exemption for airbag waste,
including the applicability of the exemption and the specific
requirements of this conditional exemption as explained in this
preamble. EPA will consider these comments in determining whether any
additional revisions to the regulation of airbag waste are necessary in
the future.
VI. Summary of Requirements of the Conditional Exemption for the
Collection of Airbag Waste
A. Applicability of Conditional Exemption
The new airbag waste conditional exemption found at 40 CFR 261.4(j)
applies to all airbag waste (i.e., airbag modules and airbag inflators)
collected from auto dealers or other airbag waste handlers for the
purpose of safe
[[Page 61559]]
disposal. Entities that generate airbag waste under the conditional
exemption are referred to as ``airbag waste handlers'' and can include
automobile dealers, independent repair facilities, collision centers,
and salvage and scrap yards.
The vast majority of items affected by the conditional exemption
will be Takata airbag waste. As of August 2018, an estimated 50 million
defective airbag inflators were under recall in approximately 37
million U.S. vehicles, with the potential for more recalls to be issued
in the future.
However, EPA has determined that the conditional exemption should
also apply to the collection of non-Takata airbag waste for the purpose
of disposal, provided that the conditions of the exemption are met.
Managing all airbag waste under the same protective requirements will
avoid confusion, increase efficiency and will help prevent non-Takata
airbag waste from being diverted into the municipal waste stream.
Because non-Takata airbag waste is expected to be a much smaller volume
waste than the recalled Takata airbag waste, in many cases automobile
dealers that generate hazardous waste would be below the Very Small
Quantity Generator threshold of 100 kilograms/month, which under the
federal RCRA requirements in 40 CFR 262.14 would allow the non-Takata
airbag waste to be disposed of in the municipal wastestream. Including
these materials under the airbag waste conditional exemption is more
protective of human health and the environment because it would
encourage their disposal at hazardous waste management facilities. To
make it clear that VSQGs have the option of managing their airbag waste
under the airbag waste conditional exemption and sending their airbag
waste to an airbag waste collection facility or a designated facility
subject to the requirements of 40 CFR part 261.4(j), EPA is including a
conforming change to the VSQG regulations at 40 CFR 262.14(a)(xi).
(Note that the airbag waste conditional exemption does not prevent the
airbag modules or airbag inflators from being managed under other
applicable exemptions as explained in the July 2018 memo referenced in
section IV.A. in this preamble) In addition, EPA also requests comment
on expanding the applicability of the airbag waste exemption to include
other similar propellent-actuated devices and their components. It
would be helpful if commenters include detailed information on these
additional wastestreams, including descriptions of the wastestreams,
volumes generated, risks posed and current management practices.
B. Limits on Accumulation Times and Quantities at Airbag Waste Handlers
Based on information provided by automobile manufacturers,
automobile dealers limit the quantity of recalled airbag modules and
inflators stored onsite. According to one automobile manufacturer,
guidance provided by Takata requires that dealers ship out the recalled
airbag inflators that have been removed from vehicles every two weeks,
or when the quantity reaches 200 inflators (i.e., a small
truckload).\31\
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\31\ EPA 2018. Compilation of Stakeholder Meeting Summaries
Regarding RCRA Regulation of Airbag Waste, Appendix 1.
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Limiting the quantity and accumulation times at airbag waste
handlers for airbag waste prevents over-accumulation and limits the
potential hazards posed by the inflators in case of a fire. Under the
airbag waste exemption finalized in this action, airbag waste handlers
are allowed to accumulate up to 250 airbag modules or airbag inflators
for up to 180 days, whichever comes first. Limiting the quantity of
airbag modules and airbag inflators accumulated onsite to 250 (i.e., a
little over one small truckload) allows the dealer and other airbag
waste handlers to prepare one truckload for shipping while continuing
to accumulate airbag waste for future shipments. The 180-day timeframe
is based on the small quantity generator limits in 40 CFR 262.16, and
addresses the future situation when the Takata recalls near completion,
resulting in a slower turn-around in recalled inflators accumulated at
the dealer. At that point it may take much longer to reach the 250-item
limit, and the 180-day time limit ensures storage does not extend
indefinitely, and that the airbag waste is safely disposed and not
abandoned.
C. Packaging, Labeling and Transportation Requirements for Airbag Waste
Handlers
During accumulation under the airbag waste exemption, airbag waste
must be packaged in a container designed to address the risk posed by
the airbag waste. Such a container would help reduce the potential for
the airbag waste to react in case of a fire, and also reduce the
projectile hazard if the defective Takata airbag inflators were to
deploy. In most cases, this container would be the same container that
the replacement airbag part was shipped in to the airbag handler, or,
in the case of salvage yards, the container provided by the salvage
recovery vendor. However, any container that meets DOT requirements for
transporting the airbag items would meet the terms of the conditional
exemption. Each container must be labeled ``Airbag Waste--Do Not
Reuse.''
Airbag waste must be shipped directly to either (1) a designated
facility as defined in 40 CFR 260.10, or (2) an airbag waste collection
facility in the United States under the control of a vehicle
manufacturer or their authorized representative, or under the control
of an authorized party administering a remedy program in response to a
recall under the National Highway Traffic Safety Administration. Airbag
waste collection facilities may include part supply centers/parts
distribution centers or any other facility authorized by vehicle
manufacturers to collect their airbag waste and hold it for more than
10 days. (Airbag waste held at a transfer facility for less than 10
days is considered to be in transport and only subject to the DOT
transportation regulations). Because the airbag waste is not subject to
hazardous waste generator requirements under 40 CFR part 262 while at
the airbag waste handler, the designated facility or the airbag waste
collection facility that accepts the airbag waste from the airbag waste
handler is considered the hazardous waste generator for the purposes of
40 CFR part 262 as the person whose act first causes a hazardous waste
to become subject to the generator regulations.
D. Tracking and Recordkeeping Requirements for Airbag Waste Handlers
As a condition for exemption from RCRA hazardous waste
requirements, airbag waste handlers must maintain at the facility and
make available upon inspection certain records that document off-site
shipments of airbag waste for a period of three years to help verify
the airbag waste went to an appropriate destination. Specifically, for
each shipment of airbag waste, the handler must maintain documentation
of the date of each shipment, the name of each transporter, the type
and quantity of airbag waste (i.e., airbag modules or airbag inflators)
shipped, and the name and address of the destination facility or airbag
waste collection facility. This recordkeeping requirement may be
fulfilled by ordinary business records, such as bills of lading,
including electronic records. In addition, airbag waste handlers are
required to maintain confirmations of receipt from the designated
facility or airbag waste collection facility in order to verify that
the airbag waste reached its intended destination and was not diverted.
These receipts must be
[[Page 61560]]
maintained at the airbag waste handler for a period of three years.
Specifically, the airbag waste handlers must maintain documentation of
receipt that includes the name and address of the designated facility
or airbag waste collection facility, the type and quantity of airbag
waste (i.e., airbag modules or airbag inflators) received, and the date
which it was received. The Agency is not requiring a specific template
or format for confirmations of receipt and anticipates that routine
business records (e.g., financial records, bills of lading, copies of
DOT shipping papers, electronic confirmations of receipt, etc.) could
contain the appropriate information sufficient for meeting this
requirement. Note that these recordkeeping requirements will be
implemented under an emergency Information Collection Request (ICR).
Based on the public comments received on this rule, EPA will publish a
separate revised ICR. See Section VIII.C in this preamble.
E. Prohibition on Reuse of Defective Airbag Modules and Airbag
Inflators
While used airbag modules and used airbag inflators are not solid
waste when reused for their intended purpose, in the case of airbag
modules and airbag inflators that are subject to a recall under the
National Highway Traffic Safety Administration, such reuse is not
allowed under RCRA. Reuse of recalled Takata inflators is particularly
dangerous due to the shrapnel producing defect that can cause death or
serious injury when the airbag is deployed, even when the vehicle
accident would otherwise be considered minor. As noted in a report by
the Takata Independent Monitor, salvaged Takata inflators may pose an
even greater risk than other defective Takata inflators due to possible
exposure to high heat and humidity for an extended time in the scrap
vehicles. In one case, a vehicle that was repaired with a salvaged
Takata airbag inflator was involved in a minor accident. The resulting
shrapnel from deployment of the defective resulted in serious injury to
the driver. The family owning the car had no reasonable way of knowing
that it contained a defective inflator.\32\ Any person who reuses a
defective inflator or causes it to be reused may therefore be placing
another person in imminent danger of death or serious injury. Such a
reuse would not meet the definition of legitimate recycling in 40 CFR
260.43 and would be considered sham recycling under 40 CFR 261.2(g).
Specifically, because the defective airbag modules and airbag inflators
cannot serve as an effective substitute for a commercial product, and
do not otherwise provide a useful contribution per 40 CFR 260.43(a)(1),
their reuse is considered to be sham recycling and prohibited under the
hazardous waste regulations.
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\32\ National Highway Traffic Safety Administration (NHTSA), The
State of Takata Airbag Recalls--Report of the Independent Monitor,
November 15, 2017. https://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/the_state_of_the_takata_airbag_recalls-report_of_the_independent_monitor_112217_v3_tag.pdf.
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VII. State Authorization
A. Applicability of Rules in Authorized States
Under section 3006 of RCRA, EPA may authorize a qualified state to
administer and enforce a hazardous waste program within the state in
lieu of the federal program, and to issue and enforce permits in the
state. A state may receive authorization by following the approval
process described in 40 CFR 271.21 (see 40 CFR part 271 for the overall
standards and requirements for authorization). EPA continues to have
independent authority to bring enforcement actions under RCRA sections
3007, 3008, 3013, and 7003. An authorized state also continues to have
independent authority to bring enforcement actions under state law.
After a state receives initial authorization, new federal
requirements and prohibitions promulgated under RCRA authority existing
prior to the 1984 Hazardous and Solid Waste Amendments (HSWA) do not
apply in that state until the state adopts and receives authorization
for equivalent state requirements. In contrast, under RCRA section
3006(g) (42 U.S.C. 6926(g)), new federal requirements and prohibitions
promulgated under HSWA provisions take effect in authorized states at
the same time that they take effect in unauthorized states. As such,
EPA carries out the HSWA requirements and prohibitions in authorized
states, including the issuance of new permits implementing those
requirements, until EPA authorizes the state to do so.
Authorized states are required to modify their programs only when
EPA enacts federal requirements that are more stringent or broader in
scope than existing federal requirements. Under RCRA section 3009,
states may impose standards that are more stringent or broader in scope
than those in the federal program (see also 40 CFR 271.1(i)).
Therefore, authorized states are not required to adopt new federal
regulations that are considered less stringent than previous federal
regulations or that narrow the scope of the RCRA program. Previously
authorized hazardous waste regulations would continue to apply in those
states that do not adopt ``deregulatory'' rules.
B. Effect on State Authorization of Interim Final Rule
The regulations finalized in this interim final rule are not
promulgated under the authority of HSWA. Thus, the standards will be
applicable on the effective date only in those states that do not have
final authorization of their base RCRA programs. Moreover, authorized
states are required to modify their programs only when EPA promulgates
federal regulations that are more stringent or broader in scope than
the authorized state regulations. For those changes that are less
stringent, states are not required to modify their program. Pursuant to
section 3009 of RCRA, states may impose more stringent regulations than
the federal program. This rule eliminates specific hazardous waste
requirements that would otherwise apply to airbag waste (airbag modules
and airbag inflators) managed under the conditional exemption, and
therefore, these changes are less stringent than the federal program
and authorized states are not required to adopt them. However, if a
state were, through implementation of state waiver authorities or other
state laws, to allow compliance with the provisions of the conditional
exemption in advance of adoption or authorization, EPA would not
generally consider such implementation a concern for purposes of
enforcement or state authorization. Of course, the state could not
implement the requirements in a way that was less stringent than the
federal requirements in this rule.
VIII. Statutory and Executive Order (E.O.) Reviews
A. Executive Order 12866: Regulatory Planning and Review & Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review. This rule has
been determined significant because it raises novel legal or policy
issues arising out of a legal mandate, the President's priorities or
the principles set forth in the Executive Order. Any changes made in
response to OMB recommendations have been documented in the docket. The
EPA prepared an economic analysis of the potential costs and benefits
associated with this action. This analysis, ``Economic Assessment of
the Safe Management of Recalled Airbags Rule'',
[[Page 61561]]
is available in the docket. This analysis estimates the impacts of the
rule relative to two separate baseline scenarios. The first baseline
scenario assumes that all aspects of the Preservation Order established
between Takata and the Department of Transportation in February 2015
and amended in April 2018 will remain in effect until the completion of
the recall process. The alternative baseline scenario assumes the
removal of the Preservation Order provisions that allow dealerships to
disregard the volume of recalled airbag inflators when determining
their hazardous waste generator status (e.g., LQG) under RCRA. For each
baseline and for the rule, EPA created a monthly schedule in order to
estimate the number of airbag inflators shipped, accumulated, and
disposed of by affected entities. EPA then assigned unit costs for
storage, transport, management, and disposal of airbag inflators for
each scenario to estimate the cost savings associated with this
regulation. The cost impacts of the rule were then calculated as the
difference between post-rule costs and costs under each baseline
scenario. In summary, this regulatory action is expected to result in a
total cost savings between $7.6 million and $56.9. million for the
duration of the Takata recalls, resulting in an estimated annual cost
savings of $1.7 million to $13.0 million per year (discounted at 7%).
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is considered an Executive Order 13771 deregulatory
action. Details on the estimated cost savings of this final rule can be
found in EPA's analysis of the potential costs and benefits associated
with this action.
C. Paperwork Reduction Act (PRA)
The information collection activities in this rule have been
granted emergency approval by the Office of Management and Budget (OMB)
under the PRA. The Information Collection Request (ICR) that has been
approved by OMB was assigned EPA ICR number 2589.02 and OMB Control
Number 2050-0221. You can find a copy of the ICR in the docket for this
rule, and it is briefly summarized here.
The collection of information is necessary in order to ensure that
the hazardous waste airbag modules and airbag inflators exempted under
this rule are safely disposed of and that defective airbag modules and
airbag inflators are not reinserted into vehicles where they would pose
an unreasonable risk of death or serious injury. Information collection
activities include requiring affected entities maintain copies of
shipping records and confirmations of receipt for three years.
In addition to the emergency ICR which will implement the
requirements for up to six months, EPA is also developing an ICR based
on comments received on this rulemaking. Towards this goal, pursuant to
section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and
information to enable it to: (i) Evaluate whether the collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (ii) evaluate the accuracy of the Agency's estimate of the
burden of the collection of information, including the validity of the
methodology and assumptions used; (iii) enhance the quality, utility,
and clarity of the information to be collected; and (iv) minimize the
burden of the collection of information on those who are to respond,
including through the use of appropriate automated electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission of
responses. EPA will consider the comments received and amend the ICR as
appropriate.
Respondents/affected entities: The respondents will primarily be
composed of automobile dealerships. These dealerships fall under NAICS
code 441: Motor Vehicle and Parts Dealers.
Respondent's obligation to respond: The recordkeeping requirements
for the interim final rule consist of maintaining at the airbag handler
for no less than three years records of (1) all off-site shipments and
(2) confirmations of receipt of airbag waste. The recordkeeping
requirements may be fulfilled by ordinary business records, such as
bills of lading, and are intended to allow the Agency to verify that
the airbag waste reaches its intended destination and is not diverted
back into vehicles. The statutory authority to require the
recordkeeping activities derives from sections 2002, 3001, 3002, 3003,
3004, 3006, 3010, and 3017 of the Solid Waste Disposal Act of 1965, as
amended by the Resource Conservation and Recovery Act of 1976 (RCRA),
as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA).
Estimated number of respondents: EPA estimates that there will be
15,256 respondents per year.
Frequency of response: EPA estimates that average facility will
make 3 relevant shipments per year over a 5-year period. The facilities
must retain documentation for each shipment.
Total estimated burden: 4,200 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $130,791 (per year), includes $0 annualized
capital or operation & maintenance costs.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
D. Regulatory Flexibility Act
This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute.
The APA exempts from notice and comment requirements rules for which an
Agency finds ``for good cause'' that notice and an opportunity to
comment are ``impracticable, unnecessary, or contrary to the public
interest.'' The Agency is invoking this exemption to address exigent
public health issues associated with the Takata airbag recalls.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more 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.
F. 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.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175. This action does not have substantial direct
effects on one or more Indian tribes, on the relationship
[[Page 61562]]
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
Section 5-502 of Executive Order 13045 provides that in emergency
situations, or where the Agency is required by law to act more quickly
than normal review procedures allow, the Agency shall comply with the
Executive Order to the extent practicable. This action is being issued
under a good cause exemption of notice and comment rulemaking under the
APA to address an emergency situation associated with defective airbag
inflators and risks to public health. The rule will remove potential
regulatory impediments associated with the Takata airbag recalls. The
recalls address explosion risks associated with faulty airbag
deployment which could cause (and have caused) serious harm to
passengers in vehicles, including children.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy. This rulemaking simply removes
potential regulatory impediments associated with the Takata airbag
recalls; therefore, by itself, this rulemaking will not have any effect
on the supply, distribution or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because the rule increases
protection of human health and the environment by removing potential
regulatory impediments associated with the Takata airbag recalls while
ensuring safe management and disposal of airbag waste. The recalls
address explosion risks associated with faulty airbag deployment which
could cause (and have caused) serious harm to passengers, including
passengers from minority and low-income communities.
M. Congressional Review Act
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. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and comment rulemaking procedures are
impracticable, unnecessary or contrary to the public interest (5 U.S.C.
808(2)). The EPA has made a good cause finding for this rule as
discussed in Section I.B. of this preamble, including the basis for
that finding.
List of Subjects
40 CFR Part 260
Environmental protection, Administrative practice and procedure,
Definitions, Hazardous waste.
40 CFR Part 261
Environmental protection, Hazardous waste, Recycling, Solid waste.
40 CFR Part 262
Environmental protection, Hazardous waste, Generator Standards.
Dated: November 13, 2018.
Andrew Wheeler,
Acting 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 citation for part 260 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6935,
6937, 6938, 6939 and 6974.
Subpart B--Definitions
0
2. Section 260.10 is amended by adding in alphabetical order
definitions for ``Airbag waste'', ``Airbag waste collection facility'',
and ``Airbag waste handler'' to read as follows:
Sec. 260.10 Definitions
* * * * *
Airbag waste means any hazardous waste airbag modules or hazardous
waste airbag inflators.
Airbag waste collection facility means any facility that receives
airbag waste from airbag handlers subject to regulation under Sec.
261.4(j) of this chapter, and accumulates the waste for more than ten
days.
Airbag waste handler means any person, by site, who generates
airbag waste that is subject to regulation under this chapter.
* * * * *
PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE
0
3. The authority citation for Part 261 continues to read as follows:
Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and
6938.
Subpart A--General
0
4. Section 261.4 is amended by adding reserved paragraph (i) and adding
paragraph (j) to read as follows:
Sec. 261.4 Exclusions.
* * * * *
(j) Airbag waste. (1) Airbag waste at the airbag waste handler or
during transport to an airbag waste collection facility or designated
facility is not subject to regulation under parts 262 through 268, part
270, or part 124 of this chapter, and is not subject to the
notification requirements of section 3010 of RCRA provided that:
(i) The airbag waste is accumulated in a quantity of no more than
250 airbag modules or airbag inflators, for no longer than 180 days;
(ii) The airbag waste is packaged in a container designed to
address the risk posed by the airbag waste and labeled ``Airbag Waste-
Do Not Reuse'';
(iii) The airbag waste is sent directly to either:
(A) An airbag waste collection facility in the United States under
the control of a vehicle manufacturer or their authorized
representative, or under the control of an authorized party
administering a remedy program in response to a recall under the
National Highway Traffic Safety Administration, or
(B) A designated facility as defined in 40 CFR 260.10;
(iv) The transport of the airbag waste complies with all applicable
U.S. Department of Transportation regulations in 49 CFR part 171
through 180 during transit;
(v) The airbag waste handler maintains at the handler facility for
no less than three (3) years records of all off-site shipments of
airbag waste and all confirmations of receipt from the receiving
facility. For each shipment, these records must, at a minimum, contain
the name of the transporter and date of the shipment; name and address
of receiving facility; and the type and quantity of airbag waste (i.e.,
airbag modules or airbag inflators) in the shipment. Confirmations of
receipt must include the name and address of the
[[Page 61563]]
receiving facility; the type and quantity of the airbag waste (i.e.,
airbag modules and airbag inflators) received; and the date which it
was received. Shipping records and confirmations of receipt must be
made available for inspection and may be satisfied by routine business
records (e.g., electronic or paper financial records, bills of lading,
copies of DOT shipping papers, or electronic confirmations of receipt).
(2) Once the airbag waste arrives at an airbag waste collection
facility or designated facility, it becomes subject to all applicable
hazardous waste regulations, and the facility receiving airbag waste is
considered the hazardous waste generator for the purposes of the
hazardous waste regulations and must comply with the requirements of 40
CFR part 262.
(3) Reuse in vehicles of defective airbag modules or defective
airbag inflators subject to a recall under the National Highway Traffic
Safety Administration is considered sham recycling and prohibited under
40 CFR 261.2(g).
PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE
0
5. The authority citation for part 262 continues to read as follows:
Authority: 42 U.S.C. 6906, 6912, 6922-6925, 6937, 6938 and
6939g.
Subpart A--General
0
6. Section 262.14 is amended by revising paragraphs (a) introductory
text and (a)(5) to read as follows:
Sec. 262.14 Conditions for exemption for a very small quantity
generator.
(a) Provided that the very small quantity generator meets all the
conditions for exemption listed in this section, hazardous waste
generated by the very small quantity generator is not subject to the
requirements of parts 124, 262 (except Sec. Sec. 262.10 through
262.14) through 268, and 270 of this chapter, and the notification
requirements of section 3010 of RCRA and the very small quantity
generator may accumulate hazardous waste on site without complying with
such requirements. The conditions for exemption are as follows:
* * * * *
(5) A very small quantity generator that accumulates hazardous
waste in amounts less than or equal to the limits in paragraphs (a)(3)
and (4) of this section must either treat or dispose of its hazardous
waste in an on-site facility or ensure delivery to an off-site
treatment, storage, or disposal facility, either of which, if located
in the U.S., is:
(i) Permitted under part 270 of this chapter;
(ii) In interim status under parts 265 and 270 of this chapter;
(iii) Authorized to manage hazardous waste by a state with a
hazardous waste management program approved under part 271 of this
chapter;
(iv) Permitted, licensed, or registered by a state to manage
municipal solid waste and, if managed in a municipal solid waste
landfill is subject to part 258 of this chapter;
(v) Permitted, licensed, or registered by a state to manage non-
municipal non-hazardous waste and, if managed in a non-municipal non-
hazardous waste disposal unit, is subject to the requirements in
Sec. Sec. 257.5 through 257.30 of this chapter;
(vi) A facility which:
(A) Beneficially uses or reuses, or legitimately recycles or
reclaims its waste; or
(B) Treats its waste prior to beneficial use or reuse, or
legitimate recycling or reclamation;
(vii) For universal waste managed under part 273 of this chapter, a
universal waste handler or destination facility subject to the
requirements of part 273 of this chapter;
(viii) A large quantity generator under the control of the same
person as the very small quantity generator, provided the following
conditions are met:
(A) The very small quantity generator and the large quantity
generator are under the control of the same person as defined in Sec.
260.10 of this chapter. ``Control,'' for the purposes of this section,
means the power to direct the policies of the generator, whether by the
ownership of stock, voting rights, or otherwise, except that
contractors who operate generator facilities on behalf of a different
person as defined in Sec. 260.10 of this chapter shall not be deemed
to ``control'' such generators.
(B) The very small quantity generator marks its container(s) of
hazardous waste with:
(1) The words ``Hazardous Waste''; and
(2) An indication of the hazards of the contents (examples include,
but are not limited to, the applicable hazardous waste
characteristic(s) (i.e., ignitable, corrosive, reactive, toxic); hazard
communication consistent with the Department of Transportation
requirements at 49 CFR part 172 subpart E (labeling) or subpart F
(placarding); a hazard statement or pictogram consistent with the
Occupational Safety and Health Administration Hazard Communication
Standard at 29 CFR 1910.1200; or a chemical hazard label consistent
with the National Fire Protection Association code 704);
(ix)-(x) [Reserved]
(xi) For airbag waste, an airbag waste collection facility or a
designated facility subject to the requirements of Sec. 261.4(j) of
this chapter.
* * * * *
[FR Doc. 2018-25892 Filed 11-29-18; 8:45 am]
BILLING CODE 6560-50-P