[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Proposed Rules]
[Pages 4536-4546]
[FR Doc No: 2022-01074]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 241

[EPA-HQ-OLEM-2020-0550; 7815-02-OLEM]
RIN 2050-AH13

Petition To Revise the Non-Hazardous Secondary Material Standard:
Proposed Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of tentative response to petition for rulemaking.

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SUMMARY: The Environmental Protection Agency (EPA or ``the Agency'') is
responding to a rulemaking petition from American Forest and Paper
Association et al. (``the petition'') requesting amendments to the Non-
Hazardous Secondary Materials (NHSM) regulations, initially promulgated
on March 21, 2011, and amended on February 7, 2013, February 8, 2016,
and February 7, 2018 under the Resource Conservation and Recovery Act
(RCRA). The NHSM regulations establish standards and procedures for
identifying whether non-hazardous secondary materials are solid wastes
when legitimately used as fuels or ingredients in combustion units. The
petition requested the following amendments: Change the legitimacy
criterion for comparison of contaminants in the NHSM to the traditional
fuel the unit is designed to burn from mandatory to ``should
consider''; remove associated designed to burn and other limitations
for creosote-treated railroad ties (CTRT); and revise the definition of
``paper recycling residuals'' (PRR) to remove the limit on non-fiber
materials in PRR that can be burned as a non-waste fuel. The EPA is
proposing to deny the requested amendments. In addition, as an
alternative to granting the third request, EPA is proposing a change to
the definition of PRR to set a numerical limit on the amount of non-
fiber materials that may be included for the residuals to be considered
a non-waste fuel.

DATES: Comments must be received on or before March 29, 2022.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OLEM-2020-0550, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460.
     Hand Delivery or Courier (by scheduled appointment only):
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004. The Docket Center's hours of
operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal
Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted by the Agency
without change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Public
Participation'' heading of the SUPPLEMENTARY INFORMATION section of
this document. Out of an abundance of caution for members of the public
and our staff, the EPA Docket Center and Reading Room are open to the
public by appointment only to reduce the risk of transmitting COVID-19.
Our Docket Center staff also continues to provide remote customer
service via email, phone, and webform. Hand deliveries and couriers may
be received by scheduled appointment only. For further information on
EPA Docket Center services and the current status, please visit us
online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Tracy Atagi, Office of Resource
Conservation and Recovery, Materials Recovery and Waste Management
Division, MC 5303P, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: The following outline is provided to aid in
locating information in this preamble.

I. General Information
    A. List of Abbreviations and Acronyms Used in This Proposed Rule
    B. What is the statutory authority for this proposed rule?
    C. Does this proposed rule apply to me?
II. Public Participation
III. Background
    A. History of NHSM Rulemaking
    B. Summary of the Petitioners' Requested Changes
    C. Background on Creosote-Treated Railroad Ties
IV. EPA Response to Petitioners' Requested Changes
V. Effect of This Proposal on Other Programs
VI. State Authority
    A. Relationship to State Programs
    B. State Adoption of the Rulemaking
VII. Costs and Benefits
VIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    J. National Technology Transfer and Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. List of Abbreviations and Acronyms Used in This Proposed Rule

Btu British thermal unit
CAA Clean Air Act
CBI Confidential business information
CFR Code of Federal Regulations
CISWI Commercial and Industrial Solid Waste Incinerator
CTRT Creosote-treated railroad ties
EPA U.S. Environmental Protection Agency
FR Federal Register
HAP Hazardous air pollutants
MACT Maximum achievable control technology
NAICS North American Industrial Classification System
ND Non-detect
NESHAP National emission standards for hazardous air pollutants
NHSM Non-hazardous secondary material
OMB Office of Management and Budget
PAH Polycyclic aromatic hydrocarbons
ppm Parts per million
PRR Paper Recycling Residuals
RCRA Resource Conservation and Recovery Act
RIN Regulatory information number
SBA Small Business Administration
SO2 Sulfur dioxide
SVOC Semi-volatile organic compound
U.S.C. United States Code
VOC Volatile organic compound

B. What is the statutory authority for this proposed rule?

    The EPA is proposing to deny the requested revisions in the AF&PA
petition and is proposing regulatory revisions to the definition of
paper recycling residuals under the authority of sections 2002(a)(1)
and 1004(27) of the Resource Conservation and Recovery Act (RCRA), as
amended, 42 U.S.C. 6912(a)(1) and 6903(27). Section 129(a)(1)(D) of the
Clean Air Act (CAA) directs the EPA to establish standards for
Commercial and Industrial Solid Waste Incinerators (CISWI), which burn
solid waste. Section 129(g)(6) of the CAA provides that the term
``solid waste'' is to be established by the EPA under RCRA (42 U.S.C.
7429(g)(6)). Section 2002(a)(1) of RCRA authorizes the Agency to
promulgate regulations as are necessary to carry out its functions
under the Act. The statutory definition of ``solid waste'' is stated in
RCRA section 1004(27).

C. Does this proposed rule apply to me?

    Categories and entities potentially affected by this action, either
directly or indirectly, include, but may not be limited to the
following:

    Generators and Potential Users \a\ of Categorical Non-Waste Fuels
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        Primary industry category or subcategory             NAICS \b\
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Utilities...............................................             221
Manufacturing...........................................      31, 32, 33
Wood Product Manufacturing..............................             321
Sawmills................................................          321113
Wood Preservation (includes railroad tie creosote                 321114
 treating)..............................................
Paper Manufacturing.....................................             322
Cement Manufacturing....................................           32731
Rail Transportation (includes line haul and short line).             482
Scenic and Sightseeing Transportation, Land (Includes:            487110
 Railroad, scenic and sightseeing)......................
Port and Harbor Operations (Used railroad ties).........          488310
Landscaping Services....................................          561730
Solid Waste Collection..................................          562111
Solid Waste Landfill....................................          562212
Solid Waste Combustors and Incinerators.................          562213
Marinas.................................................          713930
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\a\ Includes: Major Source Boilers, Area Source Boilers, and Solid Waste
  Incinerators.
\b\ NAICS--North American Industrial Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities potentially impacted by this
action. This table lists examples of the types of entities which the
EPA is aware could potentially be affected by this action. Other types
of entities not listed could also be affected. To determine whether
your facility, company, business, organization, etc., is affected by
this action, you should examine the applicability criteria in this
rule. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed in the FOR
FURTHER INFORMATION CONTACT section.

II. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2020-
0550, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit to
EPA's docket at https://www.regulations.gov 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://www.epa.gov/dockets/commenting-epa-dockets.
    Due to public health concerns related to COVID-19, the EPA Docket
Center and Reading Room are open to the public by appointment only. Our
Docket Center staff also continues to provide remote customer service
via email, phone, and webform. Hand deliveries or couriers will be
received by scheduled appointment only. For further information and
updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

III. Background

A. History of the NHSM Rulemakings

    The NHSM regulations establish standards and procedures for
identifying when non-hazardous secondary materials burned in combustion
units are solid wastes. The RCRA statute defines ``solid waste'' as
``any garbage, refuse, sludge from a waste treatment plant, water
supply treatment plant, or air pollution control facility and other
discarded material . . . resulting from industrial, commercial, mining,
and agricultural operations, and from community activities.'' (RCRA
section 1004(27) (emphasis added)). The key concept is that of
``discard'' and, in fact, this definition hinges on the meaning of the
phrase ``other discarded material,'' since this term encompasses all
other examples provided in the definition.
    The meaning of ``solid waste,'' as defined under RCRA, is of
particular importance as it relates to section 129 of the CAA. If a
material or any portion thereof is a solid waste under RCRA, a
combustion unit burning it is required to meet the CAA section 129
emission standards for solid waste incineration units. If the material
is not a solid waste, combustion units are required to meet the CAA
section 112 emission standards. CAA section 129 further states that the
term ``solid waste'' shall have the meaning ``established by the
Administrator pursuant to the Solid Waste Disposal Act.'' Id at section
7429(g)(6). The Solid Waste Disposal Act, as amended, is commonly
referred to as RCRA.
    The Agency first solicited comments on how the RCRA definition of
solid waste should apply to NHSMs when used as fuels or ingredients in
combustion units in an advanced notice of proposed rulemaking (ANPRM),
which was published in the Federal Register on January 2, 2009 (74 FR
41). The EPA then published an NHSM proposed rule on June 4, 2010 (75
FR 31844), which the EPA finalized on March 21, 2011 (76 FR 15456).
    In the March 21, 2011 rule, the EPA finalized standards and
procedures to be used to identify whether NHSMs are

solid wastes when used as fuels or ingredients in combustion units.
``Secondary material'' was defined for the purposes of that rulemaking
as any material that is not the primary product of a manufacturing or
commercial process, and can include post-consumer material, off-
specification commercial chemical products or manufacturing chemical
intermediates, post-industrial material, and scrap (codified at 40 CFR
241.2). ``Non-hazardous secondary material'' is a secondary material
that, when discarded, would not be identified as a hazardous waste
under 40 CFR part 261 (codified at 40 CFR 241.2). Traditional fuels,
including historically managed traditional fuels (e.g., coal, oil,
natural gas) and ``alternative'' traditional fuels (e.g., clean
cellulosic biomass) are not secondary materials and thus, are not solid
wastes under the rule unless discarded (codified at 40 CFR 241.2).
    A key concept included in the March 21, 2011 rule is that NHSMs
used as non-waste fuels in combustion units must meet the legitimacy
criteria specified in 40 CFR 241.3(d)(1). Application of the legitimacy
criteria helps ensure that the fuel product is being legitimately and
beneficially used and not simply being discarded through combustion. To
meet the legitimacy criteria, the NHSM must be managed as a valuable
commodity, have a meaningful heating value and be used as a fuel in a
combustion unit that recovers energy, and contain contaminants or
groups of contaminants at concentration levels comparable to (or lower
than) those in traditional fuels which the combustion unit is designed
to burn.
    Based on these criteria, the March 21, 2011 rule identified the
following NHSMs as not being solid wastes:
     The NHSM that meets the legitimacy criteria and is used as
a fuel and that remains within the control of the generator (whether at
the site of generation or another site the generator has control over)
(40 CFR 241.3(b)(1));
     The NHSM that meets the legitimacy criteria and is used as
an ingredient in a manufacturing process (whether by the generator or
outside the control of the generator (40 CFR 241.3(b)(3));
     Discarded NHSM that has been sufficiently processed to
produce a fuel or ingredient that meets the legitimacy criteria (40 CFR
241.3(b)(4)); or
     On a case-by-case petition process, NHSM that has been
determined to have been handled outside the control of the generator,
has not been discarded and is indistinguishable in all relevant aspects
from a fuel product, and meets the legitimacy criteria (40 CFR
241.3(c)).
    In 2013, the EPA amended the NHSM rules to ``clarify several
provisions in order to implement the non-hazardous secondary materials
rule as the agency originally intended.'' \1\ While the 2013 final rule
did not contain any provisions specific to creosote-treated wood or
CTRT, the EPA noted that AF&PA and the American Wood Council submitted
a letter with supporting information on December 6, 2012, seeking a
categorical non-waste determination for CTRT combusted in any unit.\2\
The EPA discussed at the time that the Agency was reviewing the
petition and also asked petitioners to provide additional information
regarding CTRT, including industry sectors that burn CTRT; types of
combustion units; types of traditional fuels that could otherwise be
burned in these combustion units; extent of use of CTRT in non-
industrial boilers; and laboratory analyses of CTRT for the
contaminants, as defined under 40 CFR 241.2, known to be significant
components of creosote, such as polycyclic aromatic hydrocarbons. The
EPA also provided notice that, assuming the additional information
supported the petitioners' representations, the Agency intended to
propose a categorical non-waste fuel determination for CTRT.
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    \1\ Commercial and Industrial Solid Waste Incineration Units:
Reconsideration and Final Amendments; Non-Hazardous Secondary
Materials That Are Solid Waste; Final Rule. 78 FR 9112, February 7,
2013.
    \2\ 78 FR 9173, February 7, 2013.
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    On February 8, 2016 (81 FR 6687), the EPA published final NHSM rule
amendments that provided a categorical non-waste fuel determination for
CTRT that undergo, at a minimum, metal removal and shredding or
grinding and are used as fuel in units designed to burn both biomass
and fuel oil as part of normal operations and not solely as part of
start-up or shut-down operations.\3\ In addition, the final rule
included a special provision for units at major source pulp and paper
mills or power producers subject to 40 CFR part 63, subpart DDDDD that
were designed to burn biomass and fuel oil as part of normal
operations, but are modified (e.g., oil delivery mechanisms are
removed) in order to use natural gas instead of fuel oil. These units
may continue to combust the CTRT as product fuel if the following
conditions are met: (A) CTRT must be burned in an existing (i.e.,
commenced construction prior to April 14, 2014) stoker, bubbling bed,
fluidized bed, or hybrid suspension grate boilers; and (B) CTRT can
comprise no more than 40 percent of the fuel that is used on an annual
heat input basis.
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    \3\ 81 FR 6723, February 8, 2016.
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    A similar categorical non-waste fuel determination approach was
applied to creosote-borate and mixtures of creosote and certain non-
creosote treated railroad ties (i.e., other treated railroad ties, or
OTRT) in the February 7, 2018 NHSM rule amendments.\4\
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    \4\ 83 FR 5318-19, February 7, 2018.
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B. Summary of the Petitioners' Requested Changes

    The Agency is responding to a rulemaking petition (``the
petition'') requesting amendments to the NHSM regulations, initially
promulgated on March 21, 2011, and amended on February 7, 2013,
February 8, 2016, and February 7, 2018 under the Resource Conservation
and Recovery Act (RCRA).
    The petition was received on December 7, 2018; petitioners included
American Forest and Paper Association (AF&PA), Association of American
Railroads (AAR), Treated Wood Council (TWC), American Short Line and
Regional Railroad Association (ASLRRA), and American Wood Council
(AWC). The petition requested the following amendments to the NHSM
regulations: (1) Change from mandatory to ``should consider'' the
legitimacy criterion for comparison of contaminants in the NHSM to the
traditional fuel the unit is designed to burn found at 40 CFR
241.3(d)(1)(iii); (2) remove associated designed to burn and other
limitations for creosote-treated railroad ties found at 40 CFR
241.4(a)(7)-(a)(10); and (3) revise the definition of paper recycling
residuals (PRR) that can be burned as non-waste found at 40 CFR 241.2
to remove the limit on non-fiber materials.

C. Background on Creosote-Treated Railroad Ties (CTRT)

    One outcome that the petitioners seek to achieve with their
requested regulatory changes is to expand the national capacity for
burning CTRT as non-waste fuel. Creosote was introduced as a wood
preservative in the late 1800s to prolong the life of railroad ties. As
creosote is a byproduct of coal tar distillation, and coal tar is a by-
product of making coke from coal, creosote is considered a derivative
of coal. Approximately 17 million railroad ties are removed from
service each year in the U.S. After railroad ties are removed from
service, they are transferred for sorting/processing. Based on
information provided by industry,\5\ the processing of the railroad
ties into fuel

by the reclamation/processing companies involves several steps. Metals
(spikes, nails, plates, etc.) are removed using a magnet, once or
several times during the process. The railroad ties are then ground or
shredded to a specified size depending on the particular needs of the
end-use combustor, with chip size typically between 1-2 inches. This
step occurs in several phases, including primary and secondary
grinding, or in a single phase. Once the railroad ties are ground to a
specific size, additional metal is removed if present and there is
further screening based on the particular needs of the end-use
combustor. Depending on the configuration of the facility and
equipment, screening occurs concurrently with grinding or at a
subsequent stage. Throughout the process, a non-toxic surfactant may be
applied to the railroad ties being processed to minimize dust. Once the
processing of CTRT is complete, the CTRT are sold directly to the end-
use combustor for energy recovery.
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    \5\ AFPA Rail Tie Petition Request December 6, 2012, EPA-HQ-
RCRA-2013-0110-0002.
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    Use of CTRT as an alternative fuel may have the potential to
produce various environmental benefits including reducing fossil fuel
use,\6\ increasing the heat value of the fuel mix and improving the
combustion temperature and conditions.\7\ Additionally, combusting CTRT
provides an alternative to landfill disposal, which studies have shown
may reduce methane emissions from anaerobic decay and extend landfill
capacity. Even when accounting for energy recovery of the methane
generated from landfill disposal of CTRT, the fuel offset from
combusting CTRT for energy recovery is estimated to be 20 times greater
than energy recovery from landfill gas.\8\
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    \6\ While creosote is a coal derivative, because the creosote
has already been used once as a preservative on railway ties,
burning those ties still may reduce the need for burning of fossil
fuels.
    \7\ In addition, one study indicates that co-firing CTRT with
coal at 10% the annual heating value may reduce emissions of certain
pollutants. However, that study is very limited and cannot be
extrapolated to the use of CTRT as a fuel in general. Little is
known about impacts of variability in CTRT or coal composition and
how these would impact emissions for any given combustor design or
control device configuration. For more information, see Creosote
Treated Railroad Ties and Coal Co-firing Technical Support Document,
available in the docket.
    \8\ Bolin and Smith, ``Creosote-Treated Ties End-of-Life
Evaluation'', p. 9.
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    However, as noted in the 2011 NHSM final rule, creosote is produced
from the process of distillation of coal tar for the purpose of
creating a wood preservative, not a fuel, and creosote has different
chemical concentrations than coal. In particular, CTRT has elevated
levels of hexachlorobenzene, a CAA 112 Hazardous Air Pollutant (HAP),
as well as other HAPs, when compared to coal. (76 FR 15483, March 21,
2011). Thus the 2016 NHSM non-waste determination is limited to CTRTs
that are used as fuel in specific types of units where CTRTs have
contaminants at levels comparable to or lower than the traditional fuel
that combustion units are designed to burn.
    In addition, the EPA has also recently become aware of reported
problems associated with processing CTRT for use as fuel. Grinding CTRT
can create dust that may blow onto neighboring properties. Processing
CTRT into fuel can also be associated with other, more-generalized
issues like excess noise from grinding, loud night-time operations, and
the smell of creosote. These issues, combined with public concerns, led
the Georgia state legislature to ban the combustion of CTRT for
commercial electricity generation in June 2020.\9\ The public
complaints that prompted this legislative action were associated with
two power plants that received modified permits allowing them to
combust fuel oil and CTRT in 2018.\10\ Since that time, the Georgia
Environmental Protection Division received at least 23 complaints
related to these combustors at the two plants.\11\ About half of these
complaints involved the smell of creosote or smoke and air quality
concerns; issues associated with dust, excess noise, and runoff were
also alleged five times each. Five complaints attributed headaches and
burning eyes and airways to the effect of creosote combustion at the
plants.
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    \9\ H.R. 857, 150th Gen Assemb., Reg. Sess. (Georgia 2020).
    \10\ See Permit Amendment Nos. 4911-195-0020-E-01-1 and 4911-
119-0025-E-04-1 available in the docket.
    \11\ See Compilation of Citizen Complaints Regarding Combustion
of Creosote-Treated Railroad Ties available in the docket.
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    Based on EPA discussions with Georgia Environmental Protection
Division, it appears that inefficient boiler operations, particularly
during start-up and shut-down operations, (which were subsequently
corrected) and CTRT grinding were most likely to blame for the
community complaints.\12\ Notably, the large majority of complaints
were associated with the facility where grinding operations took place.
Additionally, the Georgia legislation banning CTRT combustion for
commercial energy generation created an exemption for any boiler that
``also provides steam or electricity to any co-located forest products
processing plant.'' \13\ This provision was added to the legislation to
allow a CTRT-combusting paper mill in southern Georgia to continue its
operations because it had not prompted similar citizen complaints.\14\
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    \12\ See June 30, 2020 Georgia EPD Meeting Summary available in
the docket.
    \13\ H.R. 857, 150th Gen Assemble. Reg. Sess. (Georgia 2020).
    \14\ March 5, 2020 hearing before the Ga. House Natural
Resources and Environment Comm., 2019-2020 Reg. Sess. (2020)
(Statement of Alan Powell). See https://livestream.com/accounts/25225474/events/8737135/videos/202562457 at 13:30.
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    As was done in Georgia, state and local governments have authority
under their state solid waste and water programs, as well as local
ordinances, to address citizen complaints associated with the
management and processing of CTRT prior to their use as a non-waste
fuel, including problems associated with dust, excess noise, and
runoff. CTRT remain solid waste until processed to produce a non-waste
fuel per 40 CFR 241.3(b)(4) and thus remain under such solid waste
regulatory authority. In addition, a federal non-waste determination
under 40 CFR part 241 does not affect a state's authority to regulate a
non-hazardous secondary material as a solid waste under the state's
RCRA Subtitle D solid waste management program.
    It remains unclear how frequently CTRT processing causes community
concerns and how processors and state and local governments have
responded. EPA is aware of a handful of cases outside of Georgia in
which similar concerns were raised by communities where CTRT grinding
takes place,\15\ but EPA lacks comprehensive information on the
frequency and extent of such issues and challenges. These environmental
concerns may impact a material's classification as an NHSM. In order to
fulfill the ``valuable commodity'' legitimacy criterion required of
NHSM burned as fuel (40 CFR 241.3(d)(1)(i)), the material must be
``managed in a manner consistent with the analogous fuel or otherwise
be adequately contained to prevent releases to the environment.''
Likewise, when no analogous fuel exists, the material must be
``adequately contained so as to prevent releases to the environment.
EPA is requesting comment on CTRT processing to help the Agency
determine whether it is standard practice to manage CTRT intended for
combustion as an NHSM in a manner that fulfills the ``valuable
commodity'' legitimacy criterion by preventing environmental releases.
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    \15\ See Compilation of Citizen Complaints Regarding Combustion
of Creosote-Treated Railroad Ties available in the docket.

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    Specifically, EPA is requesting public comment on the potential
health and environmental risks associated with managing and processing
CTRT prior to combustion and potential approaches to addressing these
issues. Information on the types of control methods or devices
available, their efficacy, and their practicality may assist the Agency
in making decisions regarding CTRT processing in the future. Useful
comments may include information such as industry standards, best
management practices (BMPs) or standard operating procedures (SOPs),
and state or local regulations or ordinances regarding dust
containment. In addition, the Agency is requesting comment on the
location of CTRT grinding facilities and whether the communities
surrounding them face the risk of bearing an undue cumulative
environmental health burden. Moreover, EPA is also requesting comment
on other sources of environmental pollution and demographic trends
(especially regarding vulnerable populations) in the vicinity of CTRT
management locations.

IV. EPA Response to Petitioners' Requested Changes

A. Request To Change the Contaminant Comparison Criterion From
Mandatory to ``Should Consider''

1. Petitioners' Request
    40 CFR 241.3(d)(1)(iii) currently states that, ``The non-hazardous
secondary material must contain contaminants or groups of contaminants
at levels comparable in concentration to or less than those in
traditional fuel(s) that the combustion unit is designed to burn.''
Petitioners requested the following revision in the regulatory
language: ``Persons should consider whether the non-hazardous secondary
material contains contaminants or groups of contaminants at levels
comparable in concentration to or lower than those in traditional
fuel(s) that the combustion unit is capable of burning. . . . The
factor in this paragraph does not have to be met for the non-hazardous
secondary material to be considered a non-waste fuel.'' [emphasis
added].
    Petitioners' rationale for this suggested change focused on a July
7, 2017 decision by the U.S. Court of Appeals for the D.C. Circuit that
rejected mandatory compliance with the contaminant comparison criterion
portion of the legitimacy test in the context of the RCRA rules
defining ``solid wastes'' under RCRA's Subtitle C hazardous waste
program (``DSW rule''). American Petroleum Institute v. Environmental
Protection Agency, 862 F.3d 50 (D.C. Cir. 2017) (``API''). Petitioners
argued that, in light of the Court's DSW rule decision, the continued
mandatory use of contaminant comparison criterion in the NHSM rule,
including limiting railroad tie non-waste fuel classifications to
certain types of combustion units, can no longer be justified.
    Petitioners referenced preamble language the EPA used in the 2015
DSW final rule regarding the contaminant comparison criterion, and said
that ``[t]his language is consistent with the Identification of Non-
Hazardous Secondary Materials that are Solid Wastes final rule (76 FR
15456, March 21, 2011).'' (80 FR 1727, January 13, 2015) From this
preamble language petitioners concluded that the EPA has acknowledged
the equivalence of the contaminant comparison factors in the two rules
(i.e., Factor 4 in the DSW rule and third legitimacy criterion in the
NHSM rule).
    In 2017, the API Court invalidated the fourth factor in the DSW
rule, finding that ``[n]ever in the rulemaking does EPA make out why a
product that fails those criteria is likely to be discarded in any
legitimate sense of the term.'' 862 F.3d at 62. Petitioners say that
the Court also challenged the EPA's ``bare assertion that high levels
of hazardous constituents . . . could indicate discard,'' and noted
that the contaminant comparison at issue was ``not a reasonable tool
for distinguishing products from wastes.'' Id at 60, 63 (internal
quotes omitted).
    Petitioners argued that the API holding, with its critique of the
EPA's application of this element of the definition of legitimate
recycling in the DSW rule, applies with equal force to the NHSM
legitimacy criteria set forth at 40 CFR 241.3(d). See id at 63.
Therefore, petitioners alleged that, based on the reasoning and holding
in API, the contaminant comparison criterion currently contained in the
NHSM rule's legitimacy criteria and the corresponding NHSM rules for
railroad ties treated with creosote and other wood preservatives can no
longer be used as mandatory elements to determine whether a secondary
material is discarded or not.
    Furthermore, petitioners asserted that the EPA has recognized that
the contaminant comparison should not be a determining factor for
whether a material is being discarded. In its 2016 Rule on Additions to
List of Categorical Non-Waste Fuels, the EPA expressly noted that
``CTRTs do not become wastes solely because of the switch to natural
gas.'' 81 FR 6687, 6731 (Feb. 8, 2016). In that rule, the EPA reasoned
that facilities that have demonstrated the ability to burn fuel oil and
biomass should not be penalized for switching to natural gas, a fuel
that creates less air pollution. In addition, petitioners stated that
the EPA properly determined that resinated wood should qualify as a
categorical non-waste fuel under the NHSM rule, despite expressly
recognizing that this material ``may not meet the regulatory
contaminant legitimacy criteria in every situation'' (78 FR 9112, 9156,
February 7, 2013). Petitioners claimed that this prior EPA precedent is
fully consistent with the Court's decision in API and underscores the
need to eliminate the contaminant comparison as a mandatory factor in
the NHSM rule's legitimacy criteria generally, and as a condition as
applied to individual NHSMs.
2. EPA Response
    The argument that the 2017 API decision invalidates the contaminant
comparison criterion for NHSM fails because the contaminant standards
in each rule were established for different purposes and in different
contexts. The DSW rule establishes standards for legitimate recycling
of hazardous secondary materials into products. The exclusions in the
DSW rule address reclamation and specifically omit burning for energy
recovery. Unlike NHSMs, hazardous secondary materials that are burned
for energy recovery are always solid waste, unless the material is a
commercial chemical product that is itself a fuel. (See 40 CFR
261.2(c)(2)). The contaminant comparison in 40 CFR 260.43(b) compares
hazardous constituents in the product of the recycling process to the
corresponding constituents in the analogous product made from virgin
material. While 40 CFR 260.43(b) specifies that this factor ``does not
have to be met for the recycling to be considered legitimate,'' the
regulation also explains that ``[i]n evaluating the extent to which
this factor is met and in determining whether a process that does not
meet this factor is still legitimate, persons can consider exposure
from toxics in the product, the bioavailability of the toxics in the
product and other relevant considerations.'' In other words, the
definition of legitimate recycling in 40 CFR 260.43, as it relates to
hazardous constituents, focuses on the effect those hazardous
constituents have on the risks posed by the product of recycling.
    In contrast, the NHSM rule was established solely to determine
whether an NHSM that is combusted as a fuel or an ingredient is a waste
or a non-waste for purposes of applying appropriate emission standards
under CAA section

129 or CAA section 112. Without the contaminant criterion, an NHSM
could contain contaminant levels that are significantly higher than the
traditional fuels they are meant to replace and still be considered a
non-waste fuel. Burning is an inherently destructive process, even if
there is energy recovery. Thus, through the NHSM rules, the Agency
evaluates whether burning an NHSM for energy recovery also has the
effect of destroying contaminants that would not otherwise be present
in the corresponding traditional fuel, indicating discard may be
occurring.
    NHSM standards for categorical non-wastes also differ significantly
from the DSW rule because the NHSM standards allow consideration of
``other relevant factors'' in determining whether the contaminant
comparison criterion is met. (See 40 CFR 241.4(b)(5)(ii)). Thus, the
NHSM standards already provide flexibility to meet the contaminant
comparison criterion, where appropriate. The API court's rejection of
the mandatory contaminant comparison for hazardous wastes in the DSW
rule turned, in large part, on what the court viewed as a rigid and
severe standard. The court felt that the requirement ``sets the bar at
the contaminant level of the analogue without regard to whether any
incremental contaminants are significant in terms of health and
environmental risks.'' 862 F.3d at 60. However, the court went on to
commend an exception to that test in which a recycler could satisfy
this legitimacy criterion with evidence of ``lack of exposure from
toxics in the product, lack of the bioavailability of toxins in the
product, or other relevant considerations which show that the recycled
product does not contain levels of hazardous constituents that pose a
significant human health or environmental risk.'' Id. (quoting 40 CFR
260.43(a)(4)(iii) (2016)). Ultimately, the court found the exception to
be insufficient ``due to the draconian character of the procedures.''
Id. at 61. That is, if a recycler failed to satisfy any step in the
exception process, an otherwise legitimate product would be considered
to be hazardous waste. The NHSM regulations avoid these problems by
allowing the Agency to consider ``other relevant factors,'' which
offers flexibility without the ``draconian'' procedures of the 2015 DSW
rule.
    Therefore, for all of the reasons stated above, the API decision
does not directly apply because the context of burning NHSM differs
fundamentally from hazardous waste recycling.
    Finally, we also note that the NHSM legitimacy criteria have been
in place since 2011 and were upheld by the D.C. Circuit Court in Solvay
v. EPA. 608 Fed. Appx. 10 (D.C. Cir. 2015) (45 ELR 20107 Nos. 11-1189,
(D.C. Cir., 06/03/2015)). A substantive change to the contaminant
comparison criterion that would allow NHSM generators to ``consider''
significantly higher levels of contaminants in their NHSM-derived fuel,
without any threshold or indication of when such a consideration might
result in an NHSM being a solid waste, would create regulatory
uncertainty for the combustion units that burn this material and rely
on an accurate non-waste determination for their CAA permit
applicability determinations. The Agency is, therefore, proposing to
deny the Petitioners' request regarding the contaminant comparison
criterion.

B. Request To Remove Associated Designed To Burn and Other Limitations
for Creosote-Treated Railroad Ties

1. Petitioners' Request
    As discussed above, 40 CFR 241.3(d)(1)(iii) states that ``[t]he
non-hazardous secondary material must contain contaminants or groups of
contaminants at levels comparable in concentration to or less than
those in the traditional fuel(s) that the combustion unit is designed
to burn . . .'' (emphasis added). As currently applied, the petitioners
believe the designed to burn criterion means that the exact same
railroad tie is considered a solid waste when burned in one unit, but a
non-waste fuel when burned in another. The petition stated that the EPA
has acknowledged the character of the NHSM does not change depending on
the design of the boiler it goes to, and has offered no rationale for
how the existence of a fuel oil nozzle in a boiler (i.e., a boiler
originally designed to burn fuel oil, but later retrofitted to burn
natural gas) informs the question of whether railroad ties are being
legitimately used as fuel, or in fact are simply being discarded in a
hypothetical ``sham recycling'' operation.
    In addition, petitioners argued, the EPA has imposed other
restrictions unrelated to the characteristics of the NHSM itself--
including a requirement that the facility in question must have been
built before April 2014 and that the amount of NHSM combusted in that
facility may not exceed 40% of the total fuel mix in a given year.
Petitioners claimed that, in adding these various requirements
regarding the characteristics of the combustion unit, the
characteristics of the material and the motivation of the recycler are
essentially rendered irrelevant to the determination of whether the
material is a solid waste. Petitioners felt that this is contrary to
RCRA case law and an arbitrary and unreasonable basis on which to
decide whether the material is, in fact, being discarded or
legitimately used as fuel.
    Petitioners indicated that, as the agency charged with
environmental protection, the EPA should encourage the widespread use
of railroad ties and other similarly situated NHSM as fuel, rather than
restrict that use and condemn valuable fuel sources to landfills.
Furthermore, the Petitioners stated that the regulatory revisions
requested in the Petition promote environmental sustainability,
consistent with the EPA's Waste Management Hierarchy, eliminate undue
and burdensome regulation, and reduce costs associated with such
regulatory burdens.
    According to a survey conducted jointly by the Railway Tie
Association, ASLRRA and the AAR, railroads removed an average annual
total of 23,975,000 railroad ties as part of track upgrade projects in
the period from 2013 to 2016. The survey indicated that railroads sent
81.3% of those railroad ties to cogeneration facilities. As asserted in
the joint comments previously submitted by AAR, TWC, and AF&PA on
January 3, 2017, the designed to burn criterion disqualified
approximately 58% of the existing boiler capacity to burn these
railroad ties. Petitioners noted this capacity limitation means it
takes much longer to move ties through the fewer eligible facilities,
and railroads must transport the ties longer average distances to reach
an eligible facility.
    The primary alternative for managing the large volume of railroad
ties removed from the rail lines each year is landfill disposal.
According to petitioners, if substantial numbers of ties are excluded
from the scope of what can be burned for energy generation in lieu of
fossil fuels, the result will be an increased use of non-renewable
fuels and an increase in the volume of ties sent to landfills. As the
landfilled ties decay, they release greenhouse gases--including
methane--into the Earth's atmosphere, an outcome that petitioners
argued is contrary to public policy and the EPA's stated goals.
    Further, at a cost of $70 to $90 per ton, petitioners projected
that landfilling the additional railroad ties will cost railroads an
additional $74 to $95 million per year.\16\ Petitioners argue

that reduction of these burdensome and unnecessary costs is consistent
with Executive Order 13771 and the EPA's August 17, 2018 memorandum
reinforcing the work of the EPA's Regulatory Reform Task Force.
---------------------------------------------------------------------------

    \16\ EPA notes that there are other options to landfilling
CTRTs, including using them as fuel in units that are in compliance
with CAA 129 and landscaping; see Smith, Stephen T., ``2018 Railroad
Tie Survey,'' https://www.rta.org/assets/docs/RTASponsoredResearch/Environmental/2019-4-9%20Tie%20Survey%20Report%20Final.pdf.
---------------------------------------------------------------------------

2. EPA Response
    Regarding petitioners' claim that the same NHSM is treated
differently in different units, such a claim ignores the underlying
premise of the NHSM rules, which is to determine whether an NHSM that
is combusted is a waste or a non-waste for purposes of applying
appropriate emission standards under CAA section 129 or CAA section 112
to the unit burning the NHSM. Thus, it is entirely appropriate that an
NHSM would be considered a non-waste fuel when burned in a unit
designed to burn a comparable traditional fuel, and a solid waste when
burned in a unit that is not designed to burn a comparable traditional
fuel. Contaminants or groups of contaminants in the NHSM must occur at
levels comparable to or lower than those in the traditional fuel the
unit is designed to burn. Under 40 CFR 241.4(a)(7)(i) and (8)(i), each
unit must be designed to burn both biomass and fuel oil, since
contaminant levels in CTRT (e.g., SVOCs) are considerably higher than
biomass alone. Without the designed to burn criterion, contaminant
levels could be compared to any traditional fuel or combination of
fuels, resulting in a unit burning contaminants under the boiler
provisions in CAA section 112 that the unit would otherwise never have
been eligible to handle.\17\
---------------------------------------------------------------------------

    \17\ This issue would be a concern even under the petitioners'
requested change to make the contaminant comparison criterion ``to
be considered'' rather than mandatory.
---------------------------------------------------------------------------

    It should be noted that as a result of the 2013 NHSM rule, the
regulations already provide considerable flexibility in implementing
the designed to burn criterion. Persons making contaminant level
comparisons may choose a traditional fuel that can be or is burned in
the particular type of boiler, whether or not the combustion unit is
permitted to burn that traditional fuel. Broad groups of similar
traditional fuels may be used when comparing contaminant levels (e.g.,
coal, biomass, fuel oil, and natural gas). The regulatory language in
40 CFR part 241 makes it clear that a unit is considered designed to
burn a traditional fuel if it is physically capable of burning the
fuel, regardless of whether it has burned, or is permitted to burn,
such a fuel.
    Petitioners suggest replacing language in the CTRT rules regarding
which units are ``designed to burn'' CTRT with units ``operating in
compliance with all applicable permits.'' However, the NHSM rules are
used to determine which CAA permits are applicable to a unit combusting
NHSM, making the suggested reference to ``applicable permits'' circular
and meaningless.
    In regards to petitioners' comments on EPA's decision to include in
the non-waste determination CTRT burned as fuel in units at major
source pulp and paper mills or power producers subject to 40 CFR part
63, subpart DDDDD that had been originally designed to burn biomass and
fuel oil, but had switched to natural gas (see 40 CFR 241.4(7)(ii),\18\
the EPA could have reasonably limited the contaminant comparison to the
much lower contaminant levels in natural gas. However, as part of the
Agency's authority to consider ``other relevant factors'' in making a
categorical non-waste fuel determination in cases where one of the
legitimacy criteria is not met (See 40 CFR 241.4(b)(5)(ii)), the Agency
elected to include units that no longer burn fuel oil to avoid
``penalizing'' the converted units that switched to cleaner-burning
fuel.\19\ Conditions imposed on CTRT combusted in natural gas-fired
units are part of the relevant factors the EPA used to determine
whether discard has occurred (see 81 FR 6724-25).
---------------------------------------------------------------------------

    \18\ EPA is neither reopening nor taking comment on these
regulations.
    \19\ 81 FR 6724, February 8, 2016.
---------------------------------------------------------------------------

    The designed to burn criterion is fundamental to the NHSM program
since it is the primary mechanism for identifying which traditional
fuel should be used as the basis of determining whether contaminant
levels in the NHSM are comparable to or less than the traditional fuel
being replaced. Without the designed to burn criterion, CTRT could be
combusted in biomass-only boilers, including biomass boilers that are
area sources under the CAA. These boilers would have higher emissions
when burning CTRT rather than biomass. Emission standards for dioxins,
SO2, NOX, etc. for non-major sources are
addressed under the CAA section 129 standards but are not addressed by
area source boiler standards under CAA section 112 which require only
tune-ups. The Agency is therefore proposing to deny petitioners'
request regarding the designed to burn criterion. See section IV.A.
above for a discussion on the contaminant comparison criterion.

C. Preamble Discussion of Storage Times for Railroad Ties

1. Petitioners' Request
    In addition to the requested regulatory changes, the petition
raises an issue related to railroad tie storage timeframes as it
impacts NHSM eligibility as discussed in the 2016 NHSM rule. In the
preamble to that rule, the EPA discussed its presumption that storage
of ties for a year or longer without an end-use determination is not
``reasonable,'' and indicates that the material has been discarded.
Petitioners asserted that this is incompatible with the realities of
railroad operations. That is, unlike discrete facilities from which
valuable secondary materials are easily reclaimed, the railroad right-
of-way extends over thousands of miles across the United States.
Petitioners said that many locations where ties are removed are not
readily accessible except by rail and tie pickup interrupts freight and
passenger train service and competes with safety[hyphen]related
operations such as track maintenance and inspection. Train service and
safety are regulated by the Surface Transportation Board and Federal
Railroad Administration, respectively. Petitioners indicated that, due
in part to those agencies' requirements, service and safety must take
precedence over tie recovery. Petitioners asserted that these
challenges make it unrealistic to collect used ties within one year of
removal from service--but for reasons completely unrelated to the
determination of whether ties are managed as a ``valuable commodity''
under the NHSM framework. Moreover, the EPA has recognized that ``the
reasonable timeframe for storage may vary by industry'' (81 FR 6725,
February 8, 2016). In the context of railroad tie management,
petitioners asserted that three or more years is a reasonable storage
timeframe.
2. EPA Response
    Regarding storage time for CTRT (to meet the valuable commodity
criterion), petitioners misinterpreted the preamble discussion in the
February 8, 2016 rule, which explained that the amount of time for
industry to decide on value and end use of CTRT (whether sent to a
landfill, used as fuel, or another non-fuel purpose) could exceed one
year (81 FR 6725). In such circumstances, lengthy storage of the
treated railroad ties generally occurs because the railroad has not
determined the end use of the ties, not because the ties are being
stored for later transfer to a pre-established buyer. Further, CTRT
would be considered discarded until processed

into a non-waste fuel, since NHSMs that are transferred off-site for
reclamation and reuse as a fuel are considered discarded and must be
processed and meet the legitimacy criteria.
    The general reasoning for this off-site standard is that the
incentive for management of the NHSM as a valuable fuel product is
lessened when transferred to a third party. To be considered a non-
waste fuel when transferred off-site without first undergoing
processing, the material would have to undergo the petition process
under 241.3(c) to demonstrate that the material has not been discarded.
EPA continues to find, as noted in the 2016 rule, that railroad ties
removed from service can be stored for long periods of time without a
final determination regarding their final end use, and they are
considered discarded. In order for these ties to be considered a non-
waste fuel, they must be processed, thus transforming the railroad ties
into a product fuel, and then combusted in prescribed units under
prescribed conditions.

D. Request To Amend the Definition of ``Paper Recycling Residuals''

1. Petitioners' Request
    Petitioners also requested that the EPA amend the definition of
``paper recycling residuals'' (PRR) to amend the description and remove
the definitional condition that PRR that ``contain more than small
amounts of non-fiber materials . . . are not paper recycling
residuals'' (40 CFR 241.2, emphasis added). Petitioners believed that
this condition is overly vague and directly at odds with the Court's
decision in API.
    Petitioners requested that the second sentence in the definition
precluding materials that contain ``more than small amounts of non-
fiber materials'' from qualifying as PRR should be removed. They argued
that this condition suggests that the list of non-fiber materials
identified in the definition are somehow viewed as contaminants in PRR.
But, as discussed above, petitioners argue that in vacating the
contaminant comparison criterion in the DSW rule, the D.C. Circuit made
clear that the mere presence of some contaminants in a material
destined for legitimate recycling is not the basis for finding that the
material has been ``discarded'' and thus subject to regulation as a
solid waste.
    In addition to arguing that this condition is inconsistent with the
D.C. Circuit's holding in API, the petitioners believe that the ``small
amount'' limitation is overly vague. While members of the regulated
community have used good faith efforts in determining that PRR burned
as fuel meet this condition, it is well established that ``a statute
which either forbids or requires the doing of an act so vague that men
of common intelligence must necessarily guess at its meaning and differ
as to its applications, violates the first essential of due process of
law.'' FCC v. Fox Television Stations, Inc., 567 U.S. at 239, 253
(2012) (internal citation omitted). According to petitioners, the
``small amount'' criterion in the definition of PRR falls squarely
within this ``impermissibly vague'' infirmity and should be removed
from the definition to help ensure that ``those enforcing the law do
not act in an arbitrary or discriminatory way.'' FCC, 567 U.S. at 253
(internal citation omitted).
    Furthermore, petitioners argue that the current definition
describing PRR as ``composed primarily of wet strength and short wood
fibers'' is not correct as the re-pulping of recovered fibers can
result in a variety of strengths and sizes of fibers in PRR, so the
current limitation to ``wet strength and short wood fibers'' is
unnecessarily restrictive. Some residuals from recycling paper,
paperboard and corrugated containers are composed of fibers other than
wet strength fibers or short-wood fibers, but nonetheless cannot be
used to make new paper or paper products and therefore are burned for
their energy value.
2. EPA Response
    EPA disagrees with the petitioner's arguments for removing language
limiting the amount of non-fiber materials in PRR burned as a non-waste
fuel. The reasoning for not including the non-fiber materials as PRR
was not focused on discard due to contaminants present, but rather,
discard due to lack of heating value and not contributing to energy
recovery. In the April 14, 2014 proposed rule, the EPA requested, but
did not receive, information regarding the percent of non-fiber
materials commonly present in PRR and their heating value (79 FR
21017). Lacking information to the contrary, the Agency determined that
PRR with higher amounts of non-fiber materials would likely have a
lower heating value. Combustion of materials with low heating values is
typically be considered discard. PRR already has a relatively low
heating value (as fired and generated, average 3,700 Btu/lb),\20\ so
large amounts of non-fiber materials would lower the heating value of
the material, further raising the question of burning as discard.
---------------------------------------------------------------------------

    \20\ 81 FR 6716, February 8, 2016.
---------------------------------------------------------------------------

    In the review of the petition, the Agency reaffirms the previous
conclusion that residuals from processes such as mixed paper waste
recycling with significant quantities of non-fiber materials (e.g.,
clays, starches, waxes and adhesives, other plastics, filler and
coating additives, and dyes and inks) are considered to be a solid
waste fuel when combusted, due to a lack of meaningful heating
value.\21\
---------------------------------------------------------------------------

    \21\ 81 FR 6718, February 8, 2016.
---------------------------------------------------------------------------

    However, the EPA does believe that it may be more appropriate to
set a numerical threshold for non-fiber material, rather than prohibit
them entirely or rely on the term ``small amounts.'' As indicated
above, information on such threshold amounts of non-fiber materials was
not received from industry and a review of current scientific studies
also did not reveal specific amounts. As an alternative, although not
directly used for PRR as fuels, the Scrap Specifications Circular
(2021); Institute of Scrap Recycling Industries Guidelines for Paper
Stock identifies a 2% prohibitive material content limit for mixed
paper stock used for re-pulping paper.\22\ In the circular, prohibitive
material is material which by its presence, in excess of the amount
allowed, will make the pack unusable as the grade specified, as well as
any materials that may be damaging to equipment. In evaluating the
grades of paper identified in the circular, the maximum allowance of
prohibitive materials in mixed paper (which consists of all paper and
paperboard of various qualities not limited to the type of fiber
content) is 2%. The Agency has concluded that this prohibitive material
measure can provide an analogous measure for non-fiber materials
contained within PRR.
---------------------------------------------------------------------------

    \22\ Institute of Scrap Recycling Industries (ISRI) Scrap
Specifications Circular (2021), page 34; http://www.scrap2.org/specs/.
---------------------------------------------------------------------------

    Furthermore, the definition of PRR as ``composed of primarily wet
strength and short wood fibers'' was based on previously submitted
industry information (81 FR 6721, February 8, 2016). However, based on
the information submitted in this petition, the Agency agrees that the
reference to ``primarily wet strength and short wood fibers'' is too
limiting and inadvertently excludes fibers of different strength and
size that may provide heating value, and therefore we are proposing to
change the language to ``fibers that are too small or weak to be used
to make new paper and paperboard products.''

    Accordingly, the Agency proposes to revise the definition of PRR as
follows: Paper recycling residuals (PRR) means the secondary material
generated from the recycling of paper, paperboard and corrugated
containers composed primarily of fibers that are too small or weak to
be used to make new paper and paperboard products. Residuals that
contain more than 2% by weight of non-fiber materials, including
polystyrene foam, polyethlene film, other plastics, waxes, adhesives,
dyes and inks, clays, starches and other coating and filler material
are not PRR under this definition.

V. Effect of This Final Rule on Other Programs

    Beyond amending the definition of PRR, this tentative denial does
not change the effect of the NHSM regulations on other programs as
described in the March 21, 2011 NHSM final rule, as amended on February
7, 2013 (78 FR 9138), February 8, 2016 (81 FR 6688) and February 7,
2018 (83 FR 5317). Refer to section VIII of the preamble to the March
21, 2011 NHSM final rule \23\ for the discussion on the effect of the
NHSM rule on other programs.
---------------------------------------------------------------------------

    \23\ 76 FR 15456, March 21, 2011 (page 15545).
---------------------------------------------------------------------------

VI. State Authority

A. Relationship to State Programs

    This tentative denial and proposed change to the definition of PRR
does not change the relationship to state programs as described in the
March 21, 2011 NHSM final rule. Refer to section IX of the preamble to
the March 21, 2011 NHSM final rule \24\ for the discussion on state
authority including, ``Applicability of State Solid Waste Definitions
and Beneficial Use Determinations'' and ``Clarifications on the
Relationship to State Programs.'' The Agency, however, would like to
reiterate that this proposed rule (like the March 21, 2011 and the
February 7, 2013 final rules) is not intended to interfere with a
state's program authority over the general management of solid waste.
---------------------------------------------------------------------------

    \24\ 76 FR 15456, March 21, 2011 (page 15546).
---------------------------------------------------------------------------

B. State Adoption of the Rulemaking

    No federal approval procedures are included in this rulemaking
action under RCRA subtitle D. While states are not required to adopt
regulations promulgated under RCRA subtitle D, some states incorporate
federal regulations by reference or have specific state statutory
requirements that their state program can be no more stringent than the
federal regulations. In those cases, the EPA anticipates that, if
required by state law, the changes being made in this document will be
incorporated (or possibly adopted by authorized state air programs)
consistent with the state's laws and administrative procedures.

VII. Costs and Benefits

    This action is definitional in nature, and any costs or benefits
accrue to the corresponding Clean Air Act rules. In accordance with the
Office of Management and Budget (OMB) Circular A-4 requirement that the
EPA analyze the costs and benefits of regulations, the EPA prepared a
regulatory impact analysis document for the proposal that examines the
scope of indirect impacts.

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 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 because it may
raise novel policy issues. Any changes made in response to OMB
recommendations have been documented in the docket.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA as this action only changes the definition of PRR for the
purposes of the NHSM regulations. OMB has previously approved the
information collection activities contained in the existing regulations
and has assigned OMB control number 2050-0205.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, EPA concludes that the impact of concern for
this rule is any significant adverse economic impact on small entities
and that the Agency is certifying that this rule will not have a
significant economic impact on a substantial number of small entities
because the rule has no net burden on the small entities subject to the
rule. While this proposed action will provide greater clarity, reduce
regulatory uncertainty associated with paper recycling residuals, and
help increase management efficiency, it would not change the
substantive requirements of the regulations. The proposed 2% limit for
non-fiber material in PRR that would replace the current limit of
``small amounts'' is based on a voluntary consensus standard set by the
Institute of Scrap Recycling Industries (ISRI) in their Scrap
Specifications and would not require a change in current industry
practices. We have therefore concluded that this action will have no
net regulatory burden for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The costs involved in this action are imposed only
by participation in a voluntary federal program. UMRA generally
excludes from the definition of ``Federal intergovernmental mandate''
duties that arise from participation in a voluntary Federal program.
Affected entities are not required to manage the additional NHSMs as
non-waste fuels.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. It will neither impose substantial direct
compliance costs on tribal governments, nor preempt tribal law.
Potential aspects associated with the categorical non-waste fuel
determinations under this proposed rule may invoke minor indirect
tribal implications to the extent that entities generating or
consolidating these NHSMs on tribal lands could be affected. However,
any impacts are expected to be negligible. Thus, Executive Order 13175
does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in the Executive Order 12866,
and because the EPA does not believe the

environmental health or safety risks addressed by this action present a
disproportionate risk to children. The change to the definition of PRR
would not affect the overall risk to children posed by boiler
emissions. This is because the overall level of emissions, or the
emissions mix from boilers, are not expected to change significantly
because of the change in definition of PRR and these units remain
subject to the protective standards established under CAA section 112.

H. 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. The selected NHSMs affected by this
proposed action would not be generated in quantities sufficient to
significantly (adversely or positively) impact the supply,
distribution, or use of energy at the national level. Even if 100% of
the available PRR were converted to energy (an unlikely best-case
scenario), that would translate to a potential increase of only 0.002%
to 0.003% in the national energy supply, and these effects would be
localized at recycling paper mills.

I. National Technology Transfer and Advancement Act (NTTAA)

    This action involves technical standards. The EPA proposes to use a
2% by weight limit on the amount of non-fiber content allowed in paper
recycling residuals (PRR) when burned as a non-waste fuel. This is
based on a voluntary consensus standard set by the Institute of Scrap
Recycling Industries (ISRI) in their Scrap Specifications Circular
(2021); which identifies a 2% prohibitive material content limit for
paper stock used for re-pulping paper. See page 34; http://www.scrap2.org/specs/. In the circular, prohibitive material is
material which by its presence, in excess of the amount allowed, will
make the pack unusable as the grade specified, as well as any material
that may be damaging to equipment. In evaluating the grades of paper
identified in the circular, the maximum allowance of prohibitive
materials in mixed paper (which consists of all paper and paperboard of
various qualities not limited to the type of fiber content) is 2%. The
Agency proposes that this prohibitive material measure can provide an
analogous measure for allowable amounts of non-fiber materials
(including polystyrene foam, polyethlene film, other plastics, waxes,
adhesives, dyes and inks, clays, starches and other coating and filler
material) contained within PRR.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action, if finalized, would not have
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations and/or
indigenous peoples, as specified in Executive Order 12898 (59 FR 7629,
February 16, 1994). The proposed change in definition of PRR is not
expected to significantly change the overall level of emissions, or the
emissions mix from boilers, and these units remain subject to the
protective standards established under CAA section 112.
    However, if EPA were to grant the petitioners' requests, CTRT could
be combusted in biomass-only boilers, including biomass boilers that
are area sources under the CAA. As discussed earlier, these boilers
would have higher emissions when burning CTRT rather than biomass.
Emission standards for dioxins, SO2, NOX, etc.
for non-major sources are addressed under the CAA section 129 standards
but are not addressed by area source boiler standards under CAA section
112 which require only tune-ups. The risks from increased emissions
would most likely be disproportionately borne by minority and low-
income communities. In areas within three miles of boilers, the
minority share of the population was found to be 33 percent, compared
to the national average of 25 percent. For these same areas, the
percent of the population below the poverty line (16 percent) is also
higher than the national average (13 percent).

List of Subjects in 40 CFR Part 241

    Environmental protection, Air pollution control, Waste treatment
and disposal, Non-Hazardous Secondary Materials.

Michael S. Regan,
Administrator.

    For the reasons stated in the preamble, the EPA is proposing to
amend 40 CFR part 241 of the Code of Federal Regulations as follows:

PART 241--SOLID WASTES USED AS FUELS OR INGREDIENTS IN COMBUSTION
UNITS

0
1. The authority citation for part 241 continues to read as follows:

    Authority:  42 U.S.C. 6903, 6912, 7429.

0
2. Amend Sec.  241.2 by revising the definition of ``paper recycling
residuals'' to read as follows:

Sec.  241.2  Definitions.

* * * * *
    Paper recycling residuals (PRR) means the secondary material
generated from the recycling of paper, paperboard and corrugated
containers composed primarily of fibers that are too small or weak to
be used to make new paper and paperboard products. PRR that contain
more than 2% by weight of non-fiber materials, including polystyrene
foam, polyethlene film, other plastics, waxes, adhesives, dyes and
inks, clays, starches and other coating and filler material are not PRR
under this definition.
* * * * *
[FR Doc. 2022-01074 Filed 1-27-22; 8:45 am]
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[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19084-19085]
[FR Doc No: 2019-09051]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1619]

List of Patient Preference-Sensitive Priorities; Establishment of
a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of the list of patient preference-sensitive
priorities on FDA's website entitled, ``Patient Preference-Sensitive
Areas: Using Patient Preference Information (PPI) in Medical Device
Evaluation.'' As part of FDA's commitments for the reauthorization of
the Medical Device User Fee Amendments of 2017 (MDUFA IV), the Center
for Devices and Radiological Health (CDRH) committed to publish a list
of priority areas where preference-sensitive data can inform regulatory
decision making. FDA is also establishing a docket to solicit public
input on this list of preference-sensitive areas that may impact the
design and conduct of premarket medical device clinical studies,
benefit-risk assessments, and postmarket evaluation.

DATES: Submit either electronic or written comments on the notice by
July 2, 2019 to ensure that the Agency considers your comment on the
list of patient preference-sensitive priorities.

ADDRESSES: You may submit comments on this notice as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for paper submissions):
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1619 for ``List of Patient Preference-Sensitive Priorities;
Establishment of a Public Docket; Requests for Comments'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Anindita Saha, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2016, the FDA issued guidance entitled, ``Patient Preference
Information--Voluntary Submission, Review in Premarket Approval
Applications, Humanitarian Device Exemption Applications, and De Novo
Requests, and Inclusion in Decision Summaries and Device Labeling--
Guidance for Industry, Food and Drug Administration Staff, and Other
Stakeholders'' (Ref. 1), outlining how stakeholders, including industry
and patient advocacy organizations, can voluntarily collect and submit
PPI that may be used by FDA staff in regulatory decision making.
    As part of FDA's commitment for the reauthorization of MDUFA IV),
FDA committed to advancing patient input and involvement and to
identify patient preference-sensitive priority areas that may inform
regulatory decision making (Ref. 2). FDA seeks to successfully build on
our strong commitment to patients by engaging them to understand and
considering their experience and perspectives, as it relates to medical
device clinical studies, benefit-risk assessments, and postmarket
surveillance.
    As such, on December 7-8, 2017, FDA cohosted a collaborative
workshop with the Centers of Excellence in Regulatory Science and
Innovation entitled, ``Advancing Use of Patient Preference Information
as Scientific Evidence in Medical Product Evaluation'' (Ref. 3). This
workshop discussed the current progress on incorporating PPI into

benefit-risk assessments and used case examples, explored PPI methods,
and future research topics to improve the use of PPI in regulatory
decisions.
    Based on feedback attained during the workshop, FDA identified the
following parameters to assist in the identification of the priority
list of patient preference-sensitive areas for medical device review,
where:
     FDA staff are looking to better understand the full impact
of the disease or condition and treatment options on patients and/or
caregivers;
     Patients may value the benefits and risks of a technology
or treatment differently from healthcare professionals and/or
caregivers;
     Population-level differences in patient perspectives are
not well understood, due to differences in:
    [cir] Demographic characteristics;
    [cir] Stages of disease; or
    [cir] Disease phenotype; and
     There is significant public health impact (such as high
mortality or morbidity rates and high prevalence rates of the disease,
or few treatment options available such as in rare diseases).

II. Patient Preference-Sensitive Priority Areas

    Based on the above parameters, FDA generated a list of priority
preference-sensitive areas, and organized the areas into the following
categories:
     Patient values in diagnosis and treatment;
     Relevant clinical endpoints for specific patient
populations;
     Patient benefit-risk trade-offs for treatment options or
diagnostic approaches; and
     Impact of uncertainty in the benefit-risk tradeoffs.
    The current collated list of identified patient preference-
sensitive areas can be found on the FDA website at https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas. The priorities listed on the web page may be broadly
applicable to many diagnostic/therapeutic areas, while others are
specific to a disease/condition or technology. This is not an
exhaustive list of all patient preference-sensitive areas, and the
prioritization of these areas may shift over time as health
technologies and patient preference methodologies advance.

III. Other Issues for Consideration

    FDA is soliciting public input from interested persons on the
identified priority list of patient preference-sensitive topics
captured on the FDA website at https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas. In
addition, FDA is interested in responses to the following questions:
    1. Do any existing topics on the Priority List of Patient
Preference-Sensitive Areas need to be refined to better represent
patient preference-sensitive areas important to regulatory efforts?
And, if so, how? Please provide an explanation to support any
recommended refinements.
    2. Are there other areas not listed on the FDA website at https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas that FDA should consider as priority patient
preference-sensitive areas? If there are additional areas for
consideration, please identify and provide an explanation for each
additional area using the parameters outlined in Section I: Background.
    3. Are there ongoing studies or published studies that adequately
address any of these patient preference-sensitive areas in a regulatory
context? If so, please provide information or references regarding the
studies.

IV. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. Patient Preference Information--Voluntary Submission, Review in
Premarket Approval Applications, Humanitarian Device Exemption
Applications, and De Novo Requests, and Inclusion in Decision
Summaries and Device Labeling--Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-preference-information-voluntary-submission-review-premarket-approval-applications.
2. MDUFA Performance Goals and Procedures, Fiscal Years 2019 through
2022, available at https://www.fda.gov/media/102699/download.
Advancing Use of Patient Preference Information as Scientific
Evidence in Medical Product Evaluation Workshop at https://www.fda.gov/science-research/advancing-regulatory-science/advancing-use-patient-preference-information-scientific-evidence-medical-product-evaluation.

    Dated: April 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09051 Filed 5-2-19; 8:45 am]
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[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Notices]
[Page 24822]
[FR Doc No: 2016-09761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Office of Medical Products and Tobacco; Center for Drug
Evaluation and Research; Statement of Organization, Functions, and
Delegations of Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of Medical
Products and Tobacco, Center for Drug Evaluation and Research, Office
of Medical Policy has modified its structure. This new organizational
structure was approved by the Secretary of Health and Human Services on
December 15, 2016, and effective on April 17, 2016.

FOR FURTHER INFORMATION CONTACT: Melanie Keller, Office of Management,
Center for Drug Evaluation and Research, Office of Medical Products and
Tobacco, Food and Drug Administration, 10903 New Hampshire Avenue,
Silver Spring, MD 20993,<PHONE_NUMBER>.

I. Summary

    This organization will expand current activities in the Office of
Medical Policy and foster efficient oversight of clinical trials
conducted through policy initiatives that build quality upfront and
science-based inspectional approaches. This will provide an oversight
and direction for new and ongoing policy initiatives in broad-based
medical and clinical policy areas, including initiatives to improve
science and efficiency trials.
    The Food and Drug Administration, Office of Medical Products and
Tobacco, Center for Drug Evaluation and Research, Office of Medical
Policy has been restructured as follows:
    DKKNF. ORGANIZATION. The Office of Medical Policy is headed by the
Director, Office of Medical Policy and includes the following
organizational units:

Office of Medical Policy
Office of Prescription Drug Promotion
Division of Advertising and Promotion Review I
Division of Advertising and Promotion Review II

II. Delegations of Authority

    Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, all delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    This reorganization is reflected in FDA's Staff Manual Guides
(SMG). Persons interested in seeing the complete Staff Manual Guide can
find it on FDA's Web site at: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

    Authority:  44 U.S.C. 3101.

    Dated: April 19, 2016.
Sylvia M. Burwell,
Secretary of Health and Human Services.
[FR Doc. 2016-09761 Filed 4-26-16; 8:45 am]
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