Hazardous Waste Management System; Tentative Denial of Petition To Revise the RCRA Corrosivity Hazardous Characteristic, 21295-21308 [2016-08278]
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Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Proposed Rules
interstate transport obligations for the
2008 ozone NAAQS.
The EPA is proposing to disapprove
the Texas SIP for CAA section
110(a)(2)(D)(i)(I) requirements. As
explained above, the Texas analysis
does not adequately demonstrate that
the SIP contains provisions prohibiting
emissions that will significantly
contribute to nonattainment or interfere
with maintenance of the 2008 ozone
NAAQS. Moreover, the EPA’s most
recent modeling indicates that
emissions from Texas are projected to
significantly contribute to downwind
nonattainment and maintenance
receptors in other states.15
IV. Proposed Action
We propose to disapprove the portion
of a December 13, 2012 Texas SIP
submittal pertaining to CAA section
110(a)(2)(D)(i)(I), the interstate transport
of air pollution which will significantly
contribute to nonattainment or interfere
with maintenance of the 2008 ozone
NAAQS in other states. The EPA
requests comment on our evaluation of
Texas’s interstate transport SIP.
Pursuant to CAA section 110(c)(1),
disapproval will establish a 2-year
deadline for the EPA to promulgate a
FIP for Texas to address the
requirements of CAA section
110(a)(2)(D)(i) with respect to the 2008
ozone NAAQS unless Texas submits
and we approve a SIP that meets these
requirements. Disapproval does not start
a mandatory sanctions clock for Texas
pursuant to CAA section 179 because
this action does not pertain to a part D
plan for nonattainment areas required
under CAA section 110(a)(2)(I) or a SIP
call pursuant to CAA section 110(k)(5).
V. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is not a significant
regulatory action and was therefore not
submitted to the Office of Management
and Budget for review.
B. Paperwork Reduction Act (PRA)
jstallworth on DSK7TPTVN1PROD with PROPOSALS
This proposed action does not impose
an information collection burden under
15 Texas and others interested parties have
provided comments on both the NODA and
proposed CSAPR Update Rule. See Docket No.
EPA–HQ–OAR–2015–0500 at https://
www.regulations.gov. We will consider these
comments in final rulemaking to CSAPR Update
Rule. Even absent this data, Texas’s SIP failed to
adequately address the requirements of CAA
section 110(a)(2)(D)(i)(I) with respect to the 2008
ozone NAAQS.
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the PRA because it does not contain any
information collection activities.
I. National Technology Transfer and
Advancement Act
C. Regulatory Flexibility Act (RFA)
This rulemaking does not involve
technical standards.
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. This action merely
proposes to disapprove a SIP
submission as not meeting the CAA.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175. This action does not apply
on any Indian reservation land, any
other area where the EPA or an Indian
tribe has demonstrated that a tribe has
jurisdiction, or non-reservation areas of
Indian country. Thus, Executive Order
13175 does not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
The EPA interprets Executive Order
13045 as applying only to those
regulatory actions that concern
environmental health or safety risks that
the EPA has reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it merely proposes to
disapprove a SIP submission as not
meeting the CAA.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution or Use
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
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J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes the human health or
environmental risk addressed by this
action will not have potential
disproportionately high and adverse
human health or environmental effects
on minority, low-income or indigenous
populations. This action merely
proposes to disapprove a SIP
submission as not meeting the CAA.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Ozone, Nitrogen dioxide, Volatile
organic compounds.
Dated: April 4, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016–08275 Filed 4–8–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 261
[EPA–HQ–RCRA–2016–0040; FRL9944–67–
OLEM]
Hazardous Waste Management
System; Tentative Denial of Petition To
Revise the RCRA Corrosivity
Hazardous Characteristic
Environmental Protection
Agency (EPA).
ACTION: Notification of tentative denial
of petition for rulemaking.
AGENCY:
The Environmental Protection
Agency (EPA or the Agency) is
responding to a rulemaking petition
(‘‘the petition’’) requesting revision of
the Resource Conservation and
Recovery Act (RCRA) corrosivity
hazardous waste characteristic
regulation. The petition requests that
the Agency make two changes to the
current corrosivity characteristic
regulation: revise the regulatory value
for defining waste as corrosive from the
current value of pH 12.5, to pH 11.5;
and expand the scope of the RCRA
corrosivity definition to include
nonaqueous wastes in addition to the
aqueous wastes currently regulated.
After careful consideration, the Agency
is tentatively denying the petition, since
SUMMARY:
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the materials submitted in support of
the petition fail to demonstrate that the
requested regulatory revisions are
warranted, as further explained in this
document. The Agency’s review of
additional materials it identified as
relevant to the petition similarly did not
demonstrate that any change to the
corrosivity characteristic regulation is
warranted at this time.
The Agency is also soliciting public
comment on this tentative denial and
the questions raised in this action.
DATES: Comments must be received on
or before June 10, 2016.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
RCRA–2016–0040, 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://www.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Gregory Helms, Materials Recovery and
Waste Management Division, Office of
Resource Conservation and Recovery,
(5304P), Environmental Protection
Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone
number: 703–308–8855; email address:
corrosivitypetition@epa.gov.
SUPPLEMENTARY INFORMATION:
jstallworth on DSK7TPTVN1PROD with PROPOSALS
Table of Contents
I. Executive Summary
II. General Information
A. Does this action apply to me?
B. What action is EPA taking?
C. What is EPA’s authority for taking this
action?
D. What are the incremental costs and
benefits of this action?
III. Background
A. Who submitted a petition to the EPA
and what do they seek?
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B. What is corrosivity and why are
corrosive wastes regulated as hazardous?
C. What approaches are used in testing and
evaluation of materials for corrosivity?
IV. Review and Evaluation of the Petition and
Relevant Information
A. Review of Requested Regulatory
Revisions and Supporting Information
1. Request to Lower RCRA’s Corrosivity
Characteristic pH Threshold to 11.5
a. History of RCRA’s Corrosivity Regulation
b. Other Corrosivity Standards
2. Request To Include Nonaqueous
Corrosive Materials Within the Scope of
RCRA’s Corrosivity Vharacteristic
a. Exposure to World Trade Center 9/11
Dust
b. Exposure to Concrete Dust
c. Exposure to Cement Kiln Dust
B. Wastes That May Be Newly Regulated
Under Requested Revisions
C. Determining What Waste is ‘‘aqueous’’
D. Other Potentially Relevant Incidents
V. EPA’s Conclusions and Rationale for
Tentative Denial of the Petition
VI. Request for Public Comment on EPA’s
Tentative Denial of the Petition
VII. References
I. Executive Summary
This action responds to a rulemaking
petition requesting revision of the
Resource Conservation and Recovery
Act (RCRA) corrosivity hazardous waste
characteristic regulation (see 40 CFR
261.22). The petition requests that the
Agency make two changes to the current
corrosivity characteristic regulation: (1)
Revise the regulatory value for defining
waste as corrosive from the current
value of pH 12.5, to pH 11.5; and (2)
expand the scope of the RCRA
corrosivity definition to include
nonaqueous wastes in addition to the
aqueous wastes currently regulated. The
petition argues that the regulatory pH
value should be revised to pH 11.5
because information supporting this
value was, in the petitioners’ view,
inadequately considered in developing
the regulation and because petitioners
allege that this value is widely used as
a threshold for identifying corrosive
materials. The petition further argues
that corrosive properties of inhaled dust
caused injury to first responders and
others at the World Trade Center (WTC)
disaster of September 11, 2001, and that
such dusts should be regulated as
corrosive hazardous waste under RCRA.
After careful consideration, and as
described in greater detail below, the
Agency is tentatively denying the
petition, since the materials submitted
in support of the petition fail to
demonstrate that the requested
regulatory revisions are warranted.
Where used in other regulatory
frameworks, the pH 11.5 value is either
optional or a presumption that may be
rebutted by other data, a use very
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different than the way pH is used in the
RCRA corrosivity regulation.
Moreover, the dust to which 9/11 first
responders and others were exposed
was a complex mixture of pulverized
concrete, gypsum, metals, organic and
inorganic fibers, volatile organic
compounds, and smoke from the fires at
the site. No single property of the dust
can be reliably identified as the cause of
the adverse health effects in those
exposed to the WTC dust. In addition,
the injuries that were suffered by those
exposed to the WTC dust did not appear
to include corrosive injuries—i.e., the
serious destruction of human skin or
other tissues at the point of contact.
Persons exposed to simpler dusts of
concern to the petition (Cement Kiln
Dust and concrete dust) similarly did
not appear to experience corrosive
injuries. Finally, the petition does not
show that waste management activities
resulted in the exposures of concern,
nor does it identify how the proposed
regulatory changes would address these
exposures. The Agency’s evaluation of
additional materials it identified as
relevant to the petition similarly did not
demonstrate that any change to the
corrosivity characteristic regulation is
warranted at this time. The Agency is
therefore tentatively denying the
petition, and is also soliciting public
comment on this tentative denial and
the questions raised in this action.
II. General Information
A. Does this action apply to me?
The Agency is not proposing any
regulatory changes at this time. Persons
that may be interested in this tentative
denial of the rulemaking petition
include any facility that manufactures,
uses, or generates as waste, any
materials (either aqueous or
nonaqueous) with a pH 11.5 or greater,
or 2 or lower.
B. What action is EPA taking?
Under Subtitle C of RCRA, the EPA
has developed regulations to identify
solid wastes that must then be classified
as hazardous waste. Corrosivity is one of
four characteristics of wastes that may
cause them to be classified as RCRA
hazardous. The Agency defines which
wastes are hazardous because of their
corrosive properties at 40 CFR 261.22.
On September 8, 2011, the nongovernmental organization (NGO)
Public Employees for Environmental
Responsibility (PEER) and Cate Jenkins,
Ph.D.,1 submitted a rulemaking petition
to the EPA seeking changes to the
current regulatory definition of
1 Dr.
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Jenkins is an EPA employee.
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corrosive hazardous wastes under
RCRA. The petitioners express concerns
about potentially dangerous exposures
to workers and the general public from
dusts that may potentially be corrosive.
In particular, the petition is concerned
about inhalation exposures, primarily to
concrete or cement dust, which may
occur in the course of manufacturing or
handling of cement, and during building
demolitions. To address these concerns,
the petition urges the Agency to make
two changes to the current regulatory
definition of corrosive hazardous waste:
(1) Revise the pH regulatory value for
defining waste as corrosive from the
current value of pH 12.5, to pH 11.5;
and (2) expand the scope of the RCRA
corrosivity definition to include
nonaqueous wastes in addition to the
aqueous wastes currently regulated.
With this action, the Agency is
responding to requests in the petition by
publishing its evaluation of the petition
and supporting materials, and by
requesting public comment on the
topics raised by the petition. A detailed
discussion of the petition and the issues
identified by the Agency on which we
are soliciting public input are discussed
later in this document. The Agency is
soliciting information and other input
on issues related to the scope of the
changes proposed in the petition. This
may include information on the adverse
health effects, if any, that may be
avoided if the Agency were to grant the
requested regulatory changes. It may
also include information on changes in
the universe of waste (including type of
waste and volume) that may become
regulated as corrosive hazardous waste
if the Agency were to make the
requested changes, including potentially
affected industries and the possible
impact of such regulatory changes.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
C. What is EPA’s authority for taking
this action?
The corrosivity hazardous waste
characteristic regulation was
promulgated under the authority of
Sections 1004 and 3001 of the RCRA, as
amended by the Hazardous and Solid
Waste Amendments of 1984 (HSWA), 42
U.S.C. 6903 and 6921. The Agency is
responding to this petition for
rulemaking pursuant to 42 U.S.C. 6903,
6921 and 6974, and implementing
regulations 40 CFR parts 260 and 261.
D. What are the incremental costs and
benefits of this action?
As this action proposes no regulatory
changes, this action will have neither
incremental costs nor benefits.
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III. Background
A. Who submitted a petition to the EPA
and what do they seek?
On September 8, 2011, petitioners
PEER and Cate Jenkins, Ph.D., sent the
EPA a rulemaking petition seeking
revisions to the RCRA hazardous waste
corrosivity characteristic definition (see
40 CFR 261.22). On September 9, 2014,
the petitioners filed a petition for Writ
of Mandamus, arguing that the Agency
had unduly delayed in responding to
the 2011 petition, and asking the Court
to compel the Agency to respond to the
petition within 90 days. The Court
granted the parties’ joint request for a
stay of all proceedings until March 31,
2016.
The petition seeks two specific
changes to the 40 CFR 261.22(a)
definition of a corrosive hazardous
waste:
1. Reduction of the pH regulatory
value for alkaline corrosive hazardous
wastes from the current standard of pH
12.5 to pH 11.5; and
2. Expansion of the scope of the RCRA
hazardous waste corrosivity definition
to include nonaqueous wastes, as well
as currently regulated aqueous wastes.
The Agency is responding to this
RCRA rulemaking petition in
accordance with 40 CFR 260.20(c) and
(e).
B. What is corrosivity and why are
corrosive wastes regulated as
hazardous?
The term ‘‘corrosivity’’ describes the
strong chemical reaction of a substance
(a chemical or waste) when it comes
into contact with an object or another
material, such that the surface of the
object or material is irreversibly
damaged by chemical conversion to
another material, leaving the surface
with areas that appear eaten or worn
away. That is, the corrosive substance
chemically reacts with the material such
that the surface of the contacted
material is dissolved or chemically
changed to another material at the
contact site. Chemical reaction and
damage at the contact site may continue
as long as some amount of the unreacted
corrosive substance remains in contact
with the material. In situations in which
corrosive substances are being handled
by people, key risks of corrosive damage
are injury to human tissue, and the
potential to damage metal storage
containers (primarily steel) that may
hold chemicals or wastes. Corrosive
substances cause obvious damage to the
surface of living human tissue by
chemically reacting with it, and in the
process, destroying it. The strength of
the corrosive material and the duration
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of exposure largely determine the degree
or depth of injury. Corrosive injury is at
the extreme end of a continuum of
effects of dermal and ocular chemical
exposure, and results in serious and
permanent damage to skin or eyes.2
Corrosive injury is distinguished from
irritation of the skin or eyes based on
the severity and permanence of the
injury, with irritation generally being
reversible (see Globally Harmonized
System for the Classification and
Labelling of Chemicals (‘‘GHS’’ or ‘‘GHS
guidance’’) Chapters 3.2 and 3.3;
Organization for Economic Cooperation
and Development (OECD) Test Methods
404 (rev. 2015) and 405 (rev. 2012);
Grant and Kern 1955).
In 1980, EPA identified ‘‘corrosivity’’
as a characteristic of hazardous waste
because it determined that improperly
managed corrosive wastes pose a
substantial present or potential danger
to human health and the environment
(see Background Document for
Corrosivity, May 1980; hereafter referred
to as Background Document, 1980).
While other international and domestic
regulatory programs address corrosivity
in other contexts (e.g. exposure to nonwaste hazardous substances), RCRA is
the United States’ primary law
governing the management of solid and
hazardous waste from cradle to grave.
Consideration of RCRA’s corrosivity
characteristic therefore requires
consideration of whether a particular
threat of harm is one that would be
addressed within RCRA’s waste
management framework.
When in contact with steel, corrosive
substances (primarily acids) can react
with the iron to change its chemical
form and weaken it, potentially leading
to a hole in the container and a release
of the corrosive substance to the
environment. In a waste management
setting, extreme pH substances may also
mobilize toxic metals, react with other
co-disposed wastes (e.g., reaction of
acids with cyanides, to form hydrogen
cyanide gas), or change the pH of
surface water bodies, causing damage to
fish or other aquatic populations.
However, the Agency focused primarily
on the potential for injury to humans
when it initially developed the
corrosivity regulation:
‘‘Corrosion involves the destruction of both
animate and inanimate surfaces.’’
(Background Document page 3, 1980)
. . .
‘‘Wastes exhibiting very high or low pH
levels may cause harm to persons who come
2 As with thermal burns, chemical burns may heal
over time, but will typically leave scarring, or in
more severe cases, may affect the function of the
exposed body part. Ocular corrosive injury may
lead to blindness or other vision problems.
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in contact with the waste. Acids cause tissue
damage by coagulating skin proteins and
forming acid albuminates. Strong base or
alkalis, on the other hand, exert chemical
action by dissolving skin proteins, combining
with cutaneous fats, and severely damaging
keratin.’’ (Background Document page 5,
1980)
. . .
‘‘The Agency has determined that
corrosiveness, the property that makes a
substance capable of dissolving material with
which it comes in contact, is a hazardous
characteristic because improperly managed
corrosive wastes pose a substantial present or
potential danger to human health and the
environment.’’ (Background Document page
1, 1980)
In the previous discussion, the
corrosivity regulation background
document describes corrosives as
having a severe effect on human tissue.
Dissolving of skin or other tissue
proteins by chemicals, and chemically
combining with fats (stored body fat in
adipose or other human tissue) are
chemical processes which clearly
destroy the surface of human tissue and
may penetrate beyond surface layers of
skin. These adverse effects on skin have
also been described by the term
‘‘chemical burns’’ because of their
similarity to burns caused by fire or
other sources of intense heat.
Highly acidic and alkaline (basic)
substances comprise a large part of the
universe of corrosive chemicals. The
strength of acids and alkalies is
measured by the concentration of
hydrogen ions, usually in a water
solution of the acid or alkali. The
hydrogen ion concentration is expressed
as ‘‘pH’’, which is a logarithmic scale
with values generally ranging from zero
to 14. On the pH scale, pH 7 is the midpoint, and represents a neutral solution.
That is, it is neither acidic nor basic.
Solutions having pH values of less than
7 are acidic while solutions with pH
greater than 7 are basic. As pH values
move toward the extremes of the scale
(i.e., 0 and 14), the solution becomes
increasingly acidic or alkaline.
Under current RCRA regulations,
aqueous wastes having pH 2 or lower,
or 12.5 or higher, are regulated as
hazardous waste. Liquid wastes that
corrode steel above a certain rate are
also classified as corrosive under RCRA.
These values were set in consideration
of wastes’ potential to cause injury to
human tissue as well as waste
management issues, as discussed in
greater detail in section IV below
(Background Document, 1980).
Federal regulatory agencies other than
the EPA also regulate human exposure
to corrosive materials. These include the
Occupational Safety and Health
Administration (OSHA), the Department
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of Transportation (DOT), and the
Consumer Product Safety Commission
(CPSC). Further, international
organizations have also made
recommendations about controlling
human exposure to corrosive chemicals
or wastes. These include the United
Nations Guidance on the Transport of
Dangerous Goods (UNTDG), the GHS,
the International Labor Organization
(ILO), and the Basel Convention on the
Transboundary Movement of Hazardous
Waste (Basel, or the Basel Convention).
C. What approaches are used in testing
and evaluation of materials for
corrosivity?
Before 1944, there was no systematic
method for evaluating the dermal
toxicity and corrosive or irritating
properties of chemicals on human
tissue. Advances in chemistry and
medicine in the mid-20th century led to
development of a broader range of
therapeutic, cosmetic, and personal care
products (e.g., soaps, shampoo, hair
conditioner) and prompted the need to
move beyond an anecdotal collection of
largely qualitative information on
corrosivity to a systematic approach for
determining the potential for irritation
or corrosivity. Scientists working for the
U.S. Food and Drug Administration
(FDA) were the first investigators to
develop an approach that tried to be
objective and quantitative, so that
differences in the impact of different
chemicals or formulations could be
systematically identified (Draize et al.
1944, Draize 1959). Their testing
approach involved application of
chemicals or formulations directly to
animal skin or eyes (primarily rabbits),
with the results graded by the severity
of the adverse effect and the duration of
exposure required to produce those
adverse effects.3 The skin and eyes of
the test animals were assumed to be
similar to that of humans, and results
were either used directly to classify
chemicals or sometimes, for less
irritating materials, were confirmed by
testing on human subjects. The pH of
chemicals or formulations was also
correlated with the occurrence of
adverse effects on test animals in much
of the basic research that occurred
during this time period (Hughes, 1946;
Friedenwald et al., 1946; Grant and
Kern, 1955; Grant, 1962). Testing for pH
is a routine and easily performed test for
many materials (although it does require
the presence of water or another source
of hydrogen ions in the sample).
However, pH testing of very high
concentration acids or alkalies can be
3 Testing on live animals is described as in vivo
testing.
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problematic, and high concentrations of
sodium ions in solution can cause
analytical interferences (Lowry et al.,
2008).
The animal testing approach
described above evolved to become the
standard method for assessing the
corrosivity of chemicals to humans
(Weltman et al., 1965; Balls et al., 1995;
OECD Methods 404 and 405).
Variability in test results and some
differences in effects on humans were
identified as the tests were further
developed and refined. Sources of
variability included different results
when chemicals were applied to
different areas of skin, and different
reactions of animal eyes as compared
with those of humans, among others
(Weil and Scala, 1971; Phillips et al.,
1972; Vinegar, 1979). One key approach
to facilitating greater reproducibility
(precision) in testing was a standardized
grading scheme published by the FDA
(Marzulli, 1965). A version of this
testing approach has also been adopted
as guidance by the OECD to provide an
international approach to chemical
classification, with the goal of
facilitating international commerce (see
OECD Methods 404 4 and 405). Over the
intervening time, significant amounts of
animal test data have been collected and
used for classifying chemicals or
formulations as corrosive.
However, concern about testing for
corrosivity on live animals has been
expressed within the scientific
community (Balls et al., 1995) and by
non-government animal welfare
advocacy organizations (Animal Justice,
‘‘Medical Testing on Animals: A Brief
History’’ retrieved from https://
www.animaljustice.ca/blog/medicaltesting-animals-brief-history/). The
result of this concern has been the
development of alternative, in vitro
testing approaches,5 intended to reduce
reliance on in vivo animal testing.
Among the first such tests was a
commercially developed test named the
‘‘Corrositex®’’ test in 1993 (InVitro
International, ‘‘What is Corrositex?’’
2007, retrieved from https://
www.invitrointl.com/products/
4 OECD Methods 404 and 405 continue to rely on
live animal testing as the definitive test method for
assessing corrosivity and irritation potential of
chemicals and formulations. The current version of
Method 404 (2015) and Method 405 (2012) allow for
use of other tests in a weight-of-evidence approach.
However, if results are inconclusive, live animal
testing is used as a last resort. Dermal corrosion is
defined as ‘‘. . . visible necrosis through the
epidermis and into the dermis. . .’’. For corrosivity
to the eye, ‘‘A substance that causes irreversible
tissue damage to the eye . . .’’
5 In vitro, literally translated means ‘‘in glass’’. In
this context it means testing in a laboratory vessel,
rather than using a live animal.
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corrosit.htm). In this test, a ‘‘bio-barrier’’
material is placed in a tube such that it
blocks the tube, which contains an
indicator solution. The test material is
placed on the collagen plug, and
breakthrough to the indicator solution is
timed.6 Other somewhat similar testing
approaches have also been developed,
which use cultured human skin cells or
skin from a laboratory animal that has
been euthanized. Extensive work to
validate these new testing approaches
against the existing data has been done
(Barratt et al., 1998; Kolle et al., 2012;
Deshmukh et al., 2012; Vindarnell and
Mitjans, 2008), and several are now
considered validated to some degree
(see OECD Tests 430, 431, 435, 437,
438). A number of studies applying
chemical quantitative structure/activity
relationships (QSAR) to assessing
chemical corrosivity have also been
published (Hulzebos, et al., 2003; Verma
and Matthews, 2015a; Verma and
Matthews, 2015b). However, these new
tests are not yet fully integrated into the
evaluation and classification guidance
and regulations used in the U.S. and
internationally, and most guidance and
regulations rely first on existing animal
and human data. The new testing
approaches and QSAR analysis are
primarily used as alternatives to reduce
to a minimum the use of live animal
testing on new, untested chemicals or
formulations.
IV. Review and Evaluation of the
Petition and Relevant Information
A. Review of Requested Regulatory
Revisions and Supporting Information
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This action is based on the petition
and its supporting materials,7 the
Agency’s review and evaluation of this
information, information submitted by
other stakeholders, and relevant
information compiled by the Agency.
All materials and information that form
the basis for this decision are available
6 The Agency has added this test to its analytical
chemistry technical guidance for evaluating waste,
as Method 1120. While at one time the Agency
considered revising the corrosivity regulation to
rely on this test, no regulatory proposal was ever
published.
7 In reviewing the petition the Agency identified
a number of statements and/or assertions that are
factually incorrect or inaccurate or are otherwise
misstatements. The Agency has not responded to all
such statements, but rather has limited its responses
to those related to the substantive discussion of the
petition’s requests and supporting arguments in the
petition. The petition also alleges certain instances
of fraud; while the Agency denies all such
allegations, the Agency is not addressing those
allegations in this document because they are not
relevant to considerations about whether a
regulatory change to the current RCRA corrosivity
characteristic is warranted.
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in the public docket supporting this
action.
The petition presents a number of
arguments and information supporting
the requested revisions to the RCRA
corrosivity regulation. The petition’s
arguments and supporting information
are summarized and discussed below.
The petition seeks two specific
changes to the 40 CFR 261.22(a)
definition of a corrosive hazardous
waste:
1. Reduction of the pH regulatory
value for alkaline corrosive hazardous
wastes from the current standard of pH
12.5 to pH 11.5; and
2. Expansion of the scope of the RCRA
hazardous waste corrosivity definition
to include nonaqueous wastes, as well
as currently regulated aqueous wastes.
In evaluating the petition, the Agency
considered whether these specific
changes are warranted based on the
evidence in the petition and additional,
relevant information compiled by the
Agency.8
1. Request To Lower RCRA’s Corrosivity
Characteristic pH Threshold to 11.5
The current RCRA corrosivity
regulation classifies aqueous waste
having pH 12.5 or higher as corrosive
hazardous waste (40 CFR 261.22(a)(1)).
The petition seeks revision of the pH
regulatory value for alkaline corrosive
hazardous wastes from the current
standard of pH 12.5 to pH 11.5.9
In urging the Agency to make this
regulatory change, the petition argues
that a pH value of 11.5 is widely used
in other U.S. regulatory programs and
guidances, as well as in global guidance.
The petition also argues that in
promulgating the final regulation in
1980, the EPA did not give appropriate
weight to guidance by the ILO on
corrosivity that the petition considers
definitive for identifying corrosive
materials; and therefore expresses the
belief that the current standard is not
8 While the petition requests the inclusion of
nonaqueous wastes in the corrosivity characteristic
regulation, the petition does not provide any
information regarding nonaqueous acidic wastes
having pH 2 or lower. The petition appears to only
be alleging harm from nonaqueous wastes in the
upper pH, alkaline range. As such, the Agency has
similarly focused its analysis. To the extent that
petitioners allege the need to include nonaqueous
acidic wastes having pH 2 or lower as part of the
RCRA corrosivity characteristic regulation,
additional information should be submitted in the
comment period for the Agency’s evaluation.
9 The corrosivity characteristic potentially applies
to any aqueous RCRA solid waste, unless exempted
from hazardous waste regulation. In 2011, more
than 8 million tons of waste were regulated as
corrosive hazardous waste (see RCRA Biennial
Report for 2011, Exhibit 1.8).
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adequately protective of human health
and the environment.10
a. History of RCRA’s Corrosivity
Regulation
The corrosivity regulation was
promulgated on May 19, 1980 as part of
a broad hazardous waste regulatory
program that was finalized that day (45
FR 33084, 33109, and 33122). As no
timely challenges to the final corrosivity
regulation were filed in the appropriate
court pursuant to 42 U.S.C. 6976(a), the
rule, including the regulatory thresholds
used to define solid waste as exhibiting
the hazardous characteristic of
corrosivity, has been in effect since
1980.
The record supporting the May 19,
1980 rulemaking for the corrosivity
hazardous characteristic includes three
Federal Register actions (an Advanced
Notice of Proposed Rulemaking
(ANPRM), a Proposed Rule and a Final
Rule), draft and final technical
background documents, and comments
from and Agency responses to a range
of stakeholders. Review of these
materials identifies the Agency’s
proposed and final approaches to this
regulation, as well as public views on
the proposed regulation.
In the 1977 ANPRM, the Agency
discussed waste corrosivity only with
regard to the potential for waste to
damage storage containers, which could
result in waste release to the
environment. The Agency solicited
public comments on this approach to
regulation of corrosive wastes (42 FR
22332, May 2, 1977).
Following publication of the ANPRM,
the Agency released several draft
versions of the regulations under
development, including the corrosivity
regulation. Draft documents dated
September 14, 1977, November 17,
1977, and September 12, 1978 can be
found in the rulemaking docket for the
1980 regulation, as well as several
comments on these drafts. The
September 1977 draft included a
preliminary corrosivity definition based
on pH values outside the range of pH 2–
12, applied to liquid waste or a
10 Petitioners allege that EPA misrepresented the
pH levels cited in a 1972 ILO encyclopedia. As
mentioned above at footnote 7, the Agency denies
all such allegations. However, the Agency is not
addressing those allegations in this document
because they are not relevant to considerations
about whether a regulatory change to the current
RCRA corrosivity characteristic is currently
warranted. While the petitioners place great weight
on the mention of a pH of 11.5 in the 1972 ILO
encyclopedia, that encyclopedia was one among
multiple factors considered in developing the
regulation and it is in no way binding on the
Agency. No challenge to the 1980 regulation was
filed, and the statute of limitations to challenge that
1980 regulation has long since passed.
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saturated solution of non-fluid waste.
The November 1977 draft would have
defined as hazardous those wastes
having a pH outside the range of pH 3–
12, and would have potentially applied
to aqueous wastes and nonaqueous
wastes when the latter was mixed with
an equal weight of water. In a
September 1978 draft, corrosive wastes
would have been defined as aqueous
wastes having a pH outside the range of
pH 3–12.
In the 1978 proposed regulations, the
Agency proposed to identify corrosive
hazardous waste based on the pH of
aqueous solutions, and an evaluation of
the rate at which a liquid waste would
corrode steel. Waste aqueous solutions
having a pH less than or equal to pH 3,
or greater than or equal to pH 12 were
proposed to be classified as RCRA
corrosive hazardous waste (43 FR
58956, December 18, 1978). Concerns
identified by the Agency in the proposal
included the ability of corrosives to
mobilize toxic metals, corrode waste
storage containers, corrode skin and
eyes, and cause damage to aquatic life
(by changing the pH of waterbodies).
The background support document for
the proposal elaborated on EPA’s
concerns about corrosion to skin, noting
that the regulation was intended to
include as corrosive those waste ‘‘. . .
substances that cause visible destruction
or irreversible alteration in human skin
tissue at the site of contact.’’ (Draft
Background Document on Corrosiveness
page 5, December 15th, 1978; hereafter
referred to as ‘‘Draft Background
Document, 1978’’). The pH of wastes
was used as the basis of the regulation
because it could be used to evaluate
both skin damage and toxic metal
mobility (see Draft Background
Document pages 13 and 14, 1978). The
Agency also expressed some concern
about solid corrosives, and requested
that the public provide information on
the potential hazards of solids that may
be corrosive.
The Agency received many comments
on the regulatory proposals made that
day, as significant parts of the RCRA
program were proposed. The comments
received addressed a number of topics
raised by the proposal, including the
proposed corrosivity regulation.
The majority of public comments
urged expanding the range of pH values
that would not be classified as
corrosive. For example, some
commenters urged the Agency to raise
the alkaline range pH regulatory value
to either pH 12.5 or 13, in part, because
they believed the proposed pH value
would have resulted in lime-stabilized
wastes, which when treated were
otherwise non-hazardous, being
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classified as hazardous because of their
pH. These commenters also believed
treatment to de-characterize these
wastes (i.e., make them less corrosive)
would potentially allow the
mobilization of toxic metals that were
stable in the waste at the higher pH. The
Agency generally agreed with these
concerns and set a final alkaline range
pH value of 12.5 and above for defining
corrosive hazardous waste.11 The
petition reflects concern about this as
part of the basis for the pH regulatory
value, and argues that it is no longer
necessary or a valid basis for the
regulation because of other changes in
the regulations of wastewater treatment
sludges in particular. However, there is
no documentation in the petition
supporting these assertions. High
alkalinity materials continue to be used
as an important option in the treatment
of metal-bearing wastes to reduce metal
mobility (see LDR Treatment
Technology BDAT Background
Document pages 101–109, January 1991;
Chen et al., 2009; Malvia and
Chaudhary, 2006).
b. Other Corrosivity Standards
Among the arguments made by the
petition is the assertion that a pH value
of 11.5 is widely used in other U.S.
regulatory programs and guidances, as
well as in global guidance.12 This
assertion, however, is largely inaccurate
and fails to support a regulatory change
for several reasons. As discussed in
more detail below, the classification of
materials as corrosive and use of pH
11.5 in this process is far more
complicated than portrayed by the
petition. Moreover, even where pH 11.5
is incorporated as a presumptive
benchmark in other regulatory programs
or guidance (for example, pH 11.5 is
identified by the 1972 ILO Encyclopedia
of Occupational Safety and Health
(‘‘1972 ILO Encyclopedia’’)), that fact
alone is insufficient to demonstrate that
the same benchmark is appropriate for
regulation of hazardous waste under
RCRA. While it is useful to consider
information on how corrosivity is
measured and regulated by other
organizations, EPA is not bound under
RCRA to rely on voluntary standards or
the decisions of other regulatory
agencies, or even regulations or
11 The pH of wastes is determined using EPA
Method 9040.
12 Use of a pH value of 11.5 was apparently
suggested by Hughes (1946) and Grant (1962) based
on empirical observations of the effects of sodium
hydroxide solutions on the eyes of test animals. It
is not clear whether the 11.5 value was
systematically assessed to determine its
applicability to other alkaline solutions or to dermal
exposures.
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guidance developed by EPA under other
statutory authorities.
The corrosive potential of materials is
addressed by a number of national and
international organizations. Among the
organizations that address corrosivity,
the following rely on information from
human exposure, animal tests, or other
tests (as discussed previously) as the
primary determinative factor in
classifying a material as corrosive,
rather than relying on pH: The UNTDG,
the GHS, the DOT, the OSHA, the U.S.
National Institute for Occupational
Safety and Health (NIOSH), the CPSC
and U.S. EPA regulations of pesticides
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA).13 14
The UNTDG guidelines include
criteria for classifying materials as
corrosive, and reference the OECD test
methods for applying the UNTDG
corrosivity criteria. Classification as
corrosive under the UNTDG guidelines
is based on full thickness destruction of
intact skin. (UNTDG Model regulations
Chapter 2.8, Rev. 18, 2013, and UNTDG
test methods Section 37, Rev. 5 2009).
In 2003, the UN published its GHS
guidance, which addresses corrosivity,
among other chemical hazards. The
2013 version of GHS (Rev. 5, 2013)
addresses chemical corrosivity to skin
and eyes in separate sections of the
guidance. For classification as corrosive
to skin (GHS Chapter 3.2), a material
must result in skin tissue destruction.
The GHS tiered evaluation approach
(Figure 3.2.1) relies primarily on
available human data (case studies) for
making a corrosivity determination,
then animal data, and references the use
of material pH in the third tier of the
evaluation.
The UN expert groups responsible for
developing the UNTDG and GHS
guidances have been working for a
number of years (since at least 2010) to
harmonize the corrosivity definitions of
the two guidance documents. As of
April 2015, there was no consensus on
how to define corrosivity, and work of
the two groups is ongoing (see: UN
13 These organizations rely primarily on human
experience (reported case studies) and the results of
animal testing, including test results that may be
reported in scientific publications or from other
sources. Recently developed in-vitro tests are
beginning to replace animal testing.
14 The FDA does not directly regulate cosmetics
and related products based on their corrosive
potential. FDA does require that the safety of
cosmetic products be adequately substantiated
before they are sold, unless they bear a warning
label noting that the safety of the product has not
been determined (see 21 CFR 740.10) While the
original protocol for testing on animals resulted
from its needs, and was developed by FDA
scientists (Draize et al., 1944, 1959), the FDA does
not specify required testing for cosmetics.
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working document ST/SG/AC.10/C.3/
2015/21 and ST/SG/AC.10/C.4?2015/2,
April 2015, retrieved from: https://
www.unece.org/fileadmin/DAM/trans/
doc/2015/dgac10c3/ST-SG-AC.10-C.32015-21e-ST-SG-AC.10-C.4-20152e.pdf).
Current ILO guidance in the ILO
Encyclopedia of Occupational Safety
and Health urges reliance on
international agreements, and the
UNTDG guidance in particular for
chemicals and the Basel Convention for
waste (see ILO Encyclopedia, freely
available at https://www.ilo.org/
safework/info/publications/
WCMS_113329/lang-en/index.htm). As
discussed previously, the UNTDG
guidance does not refer to either pH in
general or to a particular pH range.
Finally, the Basel Convention also has
a physical and chemical hazard
classification system for waste that
addresses corrosivity and which is
described in several Annexes to the
Convention. The Basel Convention does
not rely on the 11.5 pH value in
defining corrosive waste as a general
matter in Annex III, but does rely on it
as a rebuttable presumptive value for
corrosive solutions in the Annex IX
(non-hazardous) waste listings. Under
the Basel Convention, listed hazardous
waste can be delisted by showing that
it exhibits no Annex III characteristics.
Unlike many of the other regulatory
frameworks that the petitioners cite, the
Basel Convention classification system,
like RCRA, applies specifically to
hazardous waste management. However,
the Basel Convention and its hazardous
waste classification system take into
account the limited capabilities of the
developing countries to manage
hazardous waste and other waste (see
Preamble to the Basel Convention). The
Basel Convention takes a precautionary
approach, broadly characterizing
materials as hazardous out of an
abundance of caution. The U.S., on the
other hand, has substantial capacity for
proper management of both hazardous
and non-hazardous wastes, and
therefore current RCRA regulations do
not incorporate the level of precaution
that the Basel Convention does in
classifying waste as hazardous under
RCRA.15
15 A significant purpose of the Basel Convention
is to control the export of hazardous waste from
developed to developing countries, because many
developing countries do not have the capacity to
safely manage either hazardous or non-hazardous
waste. Most Basel hazardous waste listings do not
include concentration values for hazardous
constituents below which the waste would be
considered non-hazardous, because many
developing nations do not have adequate capacity
to safely manage even non-hazardous waste. Basel
listings are written so wastes posing any degree of
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Additionally, the EPA considers
degrees of risk in classifying waste as
hazardous, taking into account the
comprehensive nature of the U.S. waste
management system. The United States
has extensive regulatory and physical
capacity for environmentally sound
waste management, including capacity
for management of both hazardous and
non-hazardous waste. Many forms of
mismanagement that may occur in
developing nations are already illegal in
the U.S., and so any such
mismanagement would not be
considered a basis for revising or
developing new hazardous waste
regulations (that is, types of waste
mismanagement that are already illegal
under RCRA would be addressed as
enforcement/compliance issues, rather
than as the basis for new regulations).
Further, the structure of the Basel
hazardous waste classification system is
different from that of RCRA. While the
presumption of corrosiveness at pH 11.5
under Basel is rebuttable using the
Annex III criteria, the RCRA corrosivity
definition is a hard value, and there is
no opportunity in the RCRA regulations
to show that a waste is non-corrosive
despite its exceedance of the regulatory
criteria. Seen in this light, the degree of
precaution incorporated in Basel’s use
of pH 11.5 may not be warranted in U.S.
waste regulations.
In the U.S., the DOT hazardous
materials regulatory definition of
‘‘corrosive material’’ is a narrative that
does not reference the pH of materials.
Rather, corrosive material is defined as
‘‘. . . a liquid or solid that causes full
thickness destruction of human skin at
the site of contact within a specified
period of time’’ (see 49 CFR 173.136(a)).
DOT referenced the 1992 OECD testing
guideline #404, among other
international guidances, when it
updated its regulations to harmonize
with the UNTGD Guidance (59 FR
67390, 67400 and 67508, December 29,
1994). The OECD Testing Guideline
#404 is based on results of live animal
testing or other direct experience with
the chemical, although testing on live
animals is being phased out where
possible.
OSHA identifies the hazards of
chemicals to which workers may be
exposed, including corrosivity hazards.
OSHA recently harmonized its Hazard
Communication Standard (HCS) with
the GHS classification criteria,
including a modified version of the GHS
criteria for corrosivity (GHS Revision 3,
hazard may be subject to the Basel notice and
consent provisions, thereby enabling developing
countries to refuse waste shipments they are unable
to safely manage.
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2009; see: 77 FR 17574, 17710, and
17796 March 26, 2012). The CPSC
implements the Federal Hazardous
Substances Act (FHSA), and includes
corrosives as hazardous substances in
its implementing regulations. Under
FHSA regulations, ‘‘Corrosive means
any substance which in contact with
living tissue will cause destruction of
tissue by chemical action . . .’’ 16 CFR
1500.3(b)(7). This definition is further
elaborated at 16 CFR 1500.3(c)(3), where
a corrosive substance is one that, ‘‘. . .
causes visible destruction or irreversible
alterations in the tissue at the site of
contact.’’
The petitioners also argue that EPA
pesticides regulations rely on a pH
value of 11.5 to define corrosivity.
However, that characterization
misunderstands the regulatory
framework for product pesticides. EPA
regulation of pesticides under the
FIFRA require evaluation of the
potential for chemicals to cause primary
eye or dermal irritation as part of the
required toxicology evaluation (see 40
CFR 158.500). Test guidelines (EPA
1998a, b) describe live animal testing as
the basis for dermal or ocular irritation,
although pre-test considerations note
that substances known (based on
existing data) to be corrosive or severely
irritating, or that have been assessed in
validated in vitro tests, or have a pH of
11.5 or greater (with buffering capacity
accounted for) may be considered
irritants and need not be tested in live
animals, if the applicant so chooses. As
noted in the preamble to the relevant
rule, the Agency considered the
importance of minimizing animal
testing, and stated that it would
consider data from validated in vitro
tests as a way to reduce animal testing
requirements (see 72 FR 60934, October
26, 2007). Because pH 11.5 may be used
as an optional presumption for toxicity
categorization, the regulatory framework
contemplates that chemicals having pH
11.5 may not be corrosive, and it allows
the applicant to submit live animal
testing data demonstrating that a
particular pesticide is not a dermal or
ocular irritant.
While the pH of a material can play
some role in corrosivity determinations
in these other regulatory frameworks,
pH 11.5 is not the primary means of
identifying corrosive materials except in
the Basel Convention. In FIFRA, it may
be used as part of the basis for
precautionary labeling of pesticides, if
the registrant elects to rely on it. It is a
third-tier criteria in the GHS system, but
is not referenced by the regulations of
DOT or by the UNTDG guidance.
Further, the experts of GHS and UNTDG
are continuing work to harmonize
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model regulations for corrosive
materials, illustrating the fact that
corrosivity assessment methods and
criteria are not well settled matters.
In fact, historically, in vivo animal test
data has been the primary basis for
classification, and because of increasing
animal welfare concerns with live
animal testing, development of new
methods for evaluating the corrosivity of
materials has been an active research
area, involving the development of new
in vitro tests and structure-activity
relationship models. Alternative test
development has been driven largely by
the desire to reduce the use of live
animals, in particular, for making
corrosivity determinations for
chemicals. These alternatives to animal
testing have been validated in some
cases (Barratt et al., 1998; Kolle et al.,
2012), and incorporated into the
corrosivity evaluations of the OECD
testing framework (see OECD tests 430,
431, 435, 437, and 438, in particular). A
number of studies attempting to
correlate chemical structure with
corrosive potential, or QSAR
evaluations have also been published in
recent years. These have focused
primarily on the corrosivity potential of
organic chemicals, and attempt to
address both corrosivity and irritation
potential. (Hulezebos et al., 2005)
In addition, the pH 11.5 value in these
other frameworks is used only as an
optional approach or a rebuttable
presumption of corrosiveness. That is,
chemical manufacturers or waste
generators have in all cases the
opportunity to conduct additional
testing if they believe their product or
waste is not corrosive despite exhibiting
pH 11.5 or higher.16 However, as used
in the RCRA corrosivity regulation, the
pH of an aqueous waste determines
whether that waste is a corrosive
hazardous waste as a legal matter, and
there is no opportunity to rebut this
classification for an aqueous waste that
exhibits pH 12.5 or higher. Thus,
lowering the pH in RCRA has far16 A number of researchers have identified
solutions exhibiting pH values higher than pH 11.5
that are nonetheless not classified as corrosive.
Murphy, et al., (1982) found that none of the test
rabbits exposed to 0.1% and 0.3% NaOH solution
(pH 12.3 and pH 12.8 respectively) developed
corneal opacity (i.e., 0/6) even when the eyes were
not washed after exposure. Young et al. (1988)
identified a 1% KOH solution, with pH 13.3 as an
irritant but not corrosive. The following solutions
were also classified either as irritants or as not
dangerous: 1% NaOH, with pH 13.4; 10% NH3,
with pH 12.2; Na2CO3, with pH 11.6; and Na3PO4,
with pH 12.3. Similarly, Oliver, et al., (1988) and
Barratt et al. (1998) identified several materials
exhibiting pH values higher than pH 11.5 that were
nonetheless not classified as corrosive.
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a. Exposure to World Trade Center 9/11
Dust
caused by corrosive properties of
airborne cement dust present in the air
as a result of the buildings’ collapse.
Further, the petition argues that
regulation of these airborne dusts as
RCRA hazardous wastes would have
prompted wide-spread respirator use
and prevented first responder lung
injury, and can prevent such injury to
demolition workers and the general
public present at future building
demolitions.
However, after a thorough review of
the information currently before the
Agency,17 the Agency has tentatively
concluded that petitioners’ arguments to
include nonaqueous wastes within the
scope of the corrosivity characteristic
are not supported by the events of the
World Trade Center (WTC) for at least
three reasons: (1) It is not possible to
establish a causal connection between
the potential corrosive properties of the
dust and the resultant injuries to those
exposed; (2) the injuries documented at
the WTC in connection with potentially
harmful dust are not consistent with
injuries caused by corrosive material;
and (3) nothing submitted by petitioners
demonstrates that injury to human
health or the environment was related to
improper treatment, storage, transport,
or disposal of solid waste (i.e. the
petition does not demonstrate how
RCRA would or could address the
potential exposures alleged to be
hazardous). The Agency is seeking
comment on these tentative
conclusions.
While there is a substantial body of
research and broad consensus that
exposure to the 9/11 atmosphere for the
first hours after the collapse of the
towers, and for some time thereafter,
caused adverse health effects in first
responders and others, this atmosphere
was a complex combination of dust,
fibers, smoke, and gases. As reported by
the New York Fire Department Bureau
of Health Services (FDNY 2007; p. 24),
‘‘[w]hen the towers collapsed, an
enormous dust cloud with a high
concentration of particulate matter
consumed lower Manhattan.’’ Analysis
of the settled dust from samples
collected in the days following
September 11 shows that it consisted of
a number of materials, including
concrete dust, toxic metals, silica,
asbestos, wood fiber, fiberglass, and
smoke particulates from the fires (EPA
In seeking to expand the scope of the
corrosivity characteristic to include
nonaqueous wastes in addition to
revising the regulatory value to pH 11.5,
the petition argues that injury to 9/11
first responders, other workers, and
potentially members of the public, was
17 While the Agency has reviewed numerous
studies, and we believe we have considered key
studies, the body of literature published on the
events of 9/11/01 is voluminous. As part of
soliciting public comments the Agency is interested
in any additional key studies that should be
considered as relevant to the issues considered in
this document.
reaching implications that are not
present in other regulatory systems.
Moreover, many of the standards
discussed above are concerned with
product chemicals and formulations,
not waste. As products are
manufactured to a certain specification,
they can be evaluated for safety once,
and typically that evaluation can be
relied on going forward (unless the
formulation changes or there is some
indication the initial evaluation was
flawed). However, waste is not
manufactured to a specification, but
rather may vary from batch-to-batch,
sometimes widely. Therefore, the more
careful, thorough evaluation, as
described in OECD Method 404, for
example, is not practical for use on each
separate batch of waste generated. The
simpler approach of relying on pH value
was therefore used by the EPA in
developing the corrosivity regulation, as
pH is a useful indicator of hazard
potential, and testing for pH is
reasonable to perform for many wastes.
Finally, the petitioners argue that the
RCRA corrosivity characteristic
regulation should be changed because
other regulatory frameworks rely on it
(see petition at 12 (discussing DOT and
the Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) regulations’ cross
references to RCRA)). However, to the
extent that petitioners are concerned
about shortcomings in DOT or CERCLA
regulations, the appropriate avenue for
changes in those frameworks is to seek
changes directly to those frameworks.
The RCRA regulatory framework is
focused on management of hazardous
waste, and should not be amended
solely on the basis of perceived
shortcomings in other regulatory
frameworks.
In sum, while other regulatory
frameworks may use pH 11.5 as part of
their corrosivity determinations, the use
of pH 11.5 in these frameworks is
fundamentally different from the use of
pH in the RCRA corrosivity
characteristic regulation, and such use,
therefore, should not set a precedent for
RCRA regulation.
2. Request To Include Nonaqueous
Corrosive Materials Within the Scope of
RCRA’s Corrosivity Characteristic
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2002, Chen and Thurston, 2002;
Landrigan et al., 2004; Lorber et al.,
2007; Lioy et al., 2002; Lioy et al., 2006).
Further, while initial exposures are
known to be very high for those near the
towers when they collapsed, the
distribution of exposures is not well
documented nor quantitated (Lioy et al.,
2006; Lorber et al., 2007). Because of the
complex nature of the ambient
atmosphere on 9/11, and lack of
exposure data (although exposures were
clearly very significant for many
people), it is not possible to establish a
causal connection between the potential
corrosive properties of the dust and the
resultant injuries to those exposed, to
the exclusion of other co-occurring
exposures. These co-occurring
exposures include glass fiber, silica,
cellulose, metals, wood fiber and
fiberglass, a number of minerals (calcite,
gypsum, quartz) and a wide range of
organic polyaromatic hydrocarbons
(PAHs) and dioxin (see docket for
OSHA Sampling Results Summary;
Lippy, 2001 (NIEHS); EPA, 2002; Lioy,
2002; Chen & Thurston, 2002).
Other factors also argue against the
use of the 9/11 disaster as an event that
would support changing the RCRA
corrosivity regulation. Most, but not all,
outdoor dust samples tested for pH were
below pH 11, and so would not be
classified as corrosive hazardous waste
under the regulatory changes proposed
by the petition. These include data in
studies by EPA, 2002; USGS, 2001;
ATSDR, 2002; McGee et al., 2003; and
Lorber et al., 2007. Some indoor dust
samples had pH values as high as pH
11.8 (USGS, 2001). While the petition
discounts these data as not representing
actual exposures to the 9/11 airborne
dust, and expresses concern that the
samples were evaluated using several
different protocols,18 they are
nonetheless the only pH data known to
the Agency.
The pH values found for the WTC
dust are generally consistent with pH
testing of waste concrete fine aggregates
being recycled, for which pH values are
often less than pH 11.5 (Poon, 2006).
This is supported by information from
Material Safety Data Sheets (MSDS) for
crushed concrete aggregate, which
reported pH 7 for this material (LaFarge
MSDS, revised 3/1/2011), although
Gotoh et al. (2002) found pH values
18 Water must be added to a dust in order to test
its pH, as in EPA Method 9045. Dust pH was
evaluated by different investigators using methods
they believed appropriate for the particular studies
being conducted. Investigators used different
liquid/solid ratios, and for one data set, pH was
tested in the course of running a deionized water
leaching test (initial pH of the water approximately
pH 5.5).
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ranging from 11.6–12.6 for five samples
of concrete dust generated by building
demolition resulting from an
earthquake.
In addition, numerous studies of
exposed workers and laboratory test
animals fail to identify the gross damage
to human tissue used as a benchmark in
defining corrosive materials as an effect
resulting from exposure to WTC dust.
The 1980 RCRA background document
supporting the corrosivity regulation
notes that ‘‘[s]trong base or alkalis . . .
exert chemical action by dissolving skin
proteins, combining with cutaneous
fats, and severely damaging keratin.’’
Typical injury endpoints used in
guidance for defining a material as
corrosive describe ‘‘. . .visible necrosis
through the epidermis and into the
dermis . . .’’. ‘‘Corrosive reactions are
typified by ulcers, bleeding, bloody
scabs . . . .’’ (GHS 3.2.1).
In reviewing the published literature
describing injury to 9/11 exposed
workers and residents, none describe
gross respiratory tissue destruction or
other injuries of the severity identified
in definitions of corrosivity. Rather,
adverse effects in various studies
describe respiratory irritation and other
adverse effects. Chen & Thurston (2002)
identified ‘‘World Trade Center Cough’’,
and noted that exposure to the larger
particles cause temporary nose, throat,
and upper airway symptoms. In a
review of exposure and health effects
data, Lioy et al. (2006) identified the
major health consequences of WTC
exposure as ‘‘aerodigestive and mental
health related illnesses.’’ The WTC
aerodigestive syndrome is identified as
consisting of ‘‘. . . WTC cough, irritant
asthma or reactive airways dysfunction
syndrome and gastroesophageal reflux
disorder.’’ In September of 2011, The
Lancet published a series of articles
reviewing and updating the research on
adverse health effects suffered by those
exposed to the WTC atmosphere.
Perlman et al. (2011) identified upper
and lower respiratory effects, including
asthma, wheezing, tightness in the
chest, and reactive airway dysfunction
syndrome, as well as gastroesophageal
reflux symptoms. Wesnivesky et al.
(2011) identified updated occurrence
rates of the adverse effects described by
Perelman through a longitudinal cohort
study, and it found a 42% incidence of
spirometric abnormalities nine years
after the exposures. Jordan et al. (2011)
studied mortality among those
registered in the World Trade Center
Health Registry. No significantly
increased mortality rates (SMR) for
respiratory or heart disease were found,
although increased mortality from all
causes was found in more highly
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exposed individuals compared with the
low exposure group. Finally, ZeigOwens et al. (2011) studied cancer
incidence in New York firefighters,
including those exposed to the WTC
dust, and found a modest increase in the
cancer rates for the exposed group.
However, the authors remained cautious
in their conclusions, as no specific
organs were preferentially affected, and
the nine years since exposure does not
represent the full latency period for
development of many cancers. While
the WTC-exposed populations in these
studies experienced adverse health
effects related to exposures, they are not
effects of the nature and severity that
the corrosivity regulation was intended
to prevent.19
The petition identifies several
particular studies that the petitioners
believe demonstrate corrosive effects of
the WTC dust, and it cites to several
passages, apparently taken from these
studies as supporting the petition (see
page 30; the referenced publications are
identified in footnotes (FN) to the
petition).
The first passage identifies papers by
Weiden et al. (2010; FN 88) and Aldrich,
et al. (2010; FN 89) as the source of
information. The petition extracts a
quotation from the Weiden (2010)
paper’s discussion section that noted,
‘‘The WTC collapse produced a massive
exposure to respirable particulates, with
the larger size dust fractions having a
pH ranging from 9 to11, leading to an
alkaline ‘‘burn’’ of mucosal surfaces.’’
However, this publication presented
research on pulmonary capacity, and it
states its primary conclusion in the
paper’s abstract as follows: ‘‘Airways
obstruction was the predominant
physiological finding underlying the
reduction in lung function post
September 11, 2001, in FDNY WTC
rescue workers presenting for
pulmonary evaluation.’’ The idea of an
alkaline ‘‘burn’’ is at best inferred; it is
not an effect directly observed or
evaluated by the researchers, nor is it
one of the findings of the study. The
Aldrich et al. (2010; FN89) study
similarly conducted spirometry (lung
function) studies of exposed firefighters
19 This may raise the question of whether the
Agency should consider regulating waste dusts that
are respiratory irritants as hazardous waste under
RCRA. However, that question is outside the scope
of the petition. As discussed herein, the petition
fails to show how RCRA regulation could address
any of the alleged exposures, and therefore does not
support such regulation. Evaluation of whether the
Agency should regulate respiratory irritants as
hazardous waste would require additional
information and analysis, including evaluation of
whether ‘‘respiratory irritants’’ meet the statutory
and regulatory definition of hazardous waste; and,
if so, which tests or criteria would be appropriate
to identify such irritants.
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and others. This abstract of this study
reported that, ‘‘Exposure to World Trade
Center dust led to large declines in
FEV1 (1-second forced expiratory
volume) for FDNY rescue workers
during the first year. Overall, these
declines were persistent . . .’’. The
paper found there was no association
between time of first responder/worker
arrival at the WTC site and chronic
effects. The paper discussion did note
that the intensity of initial exposure was
linked to acute lung inflammation,
although there was no reference to
‘‘chemical burns’’ or other possible
descriptors of chemical corrosive effects
on workers’ tissues.
The petition also cites an October
2009 poster presentation/abstract (Kim
et al., 2009; FN90) from an American
College of Chest Physicians meeting
providing the results of a study of
asthma prevalence in WTC responders.
The petition is generally accurate in
reflecting the researchers’ conclusion
that asthma in WTC responders doubled
over the study period 2002–2005, and in
noting exposures to dust and toxic
pollutants following the 9/11 attacks.
There was no report in the paper of
corrosive injuries to the workers.
Footnote 91 references a New York
Times newspaper article of April 7,
2010, reporting on the pending
publication of the paper by Aldrich et
al. (2010; FN89) in the New England
Journal of Medicine. The petition quotes
from the New York Times article, noting
that, ‘‘The cloud contained pulverized
glass and cement, insulation fibers,
asbestos and numerous toxic chemicals.
It caused acute inflammation of the
airways and the lungs. Dr. Prezant
said.’’ The article also noted, ‘‘This was
not a regular fire,’’ Dr. Prezant said.
‘‘There were thousands of gallons of
burning jet fuel and an immense, dense
particulate matter cloud that enveloped
these workers for days.’’ This article
again illustrates the complex nature of
the exposures to first responders and
others at the WTC site, and does not
include corrosive injury when noting
the acute effects of this exposure.
The petition next quotes from a NY
Fire Department, Bureau of Health
Services report (FDNY, 2007; FN 92)
which reports on upper respiratory
symptoms in firefighters (cough, nasal
congestion, sore throat) from the day of
the attacks as well as at intervals up to
2–4 years in the future. The report notes
that ‘‘Particulate matter analysis has
shown a highly alkaline pH of WTC
dust (like lye), which is extremely
irritating to the upper and lower
airways.’’ Earlier discussion in the
report (p.24) notes that firefighters were
exposed to ‘‘. . . an enormous dust
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cloud with a high concentration of
particulate matter consumed lower
Manhattan.’’ The WTC dust not only
had very high particulate
concentrations, but was also a complex
mixture of materials.
Finally, the petition cites a portion of
the discussion in a paper published by
Reibman, et al., (2009; FN 94), which
notes that, ‘‘[m]easurements of settled
dust documented that these particles
were highly alkaline (pH 11), and this
property alone has been shown to be
associated with respiratory effects.
Occupational exposure to inhaled
alkaline material induces chronic
cough, phlegm, and dyspnea, as well as
upper respiratory tract symptoms.’’ This
paper presented the results of
spirometry (lung function) testing, and
concluded that the exposed population
had, ‘‘. . . persistent respiratory
symptoms with lung function
abnormalities 5 or more years after the
WTC destruction.’’ As in describing the
results of other research on the WTC
exposed populations, these studies
identify a number of adverse effects
attributable to WTC exposures from the
day of the towers’ collapse, as well as
subsequent exposures occurring during
site rescue and demolition and clean-up
activities. While the adverse effects
identified represent serious injuries to
many workers, these injuries do not
appear to include the type of gross
tissue destruction of skin or the
respiratory tract that is the underlying
basis for defining materials as corrosive
(i.e., destroying tissue by dissolving or
coagulating skin proteins). Rather, these
effects are associated with inflammatory
and irritant properties of inhaled
materials.
Similarly, laboratory toxicity studies
in which mice were exposed to
collected 9/11 dust samples (PM2.5),
adverse effects were limited to mild to
moderate degrees of airway
inflammation. The test animals did
experience increased responsiveness to
methylcholine aerosol challenge (EPA,
2002), suggesting an irritant response to
the WTC particulate matter. While these
studies again suggest an irritant
response to the 9/11 dust samples, they
do not demonstrate corrosive injury.
If one were to apply the criteria for
classifying dusts as corrosive, such as
GHS (which does provide guidance for
identifying nonaqueous corrosives) to
the WTC data, WTC dust would not
have been assessed as corrosive. GHS
defines skin corrosion as ‘‘. . . visible
necrosis, through the dermis and into
the epidermis . . . Corrosive reactions
are typified by ulcers, bleeding, bloody
scabs . . .’’ (GHS 3.2.1.). None of these
reactions to the WTC dust have been
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identified in the published literature
cited by the petition, nor in studies
identified in the Agency’s review. The
background information for the current
RCRA corrosivity characteristic
regulation references dissolution of skin
proteins, combination of the corrosive
substance with cutaneous fats, and
severe damage to keratin as the adverse
effects the regulation is intended to
prevent. These kinds of injuries have
not been reported in the published
scientific literature presenting studies of
WTC adverse effects.
The petition also argues that
classification of the 9/11 dust as RCRA
hazardous may have impacted workers’
respirator use at the 9/11 site. However,
this argument does not appear to have
support. OSHA’s regulations govern
worker safety (e.g., respirator use) when
workers are handling hazardous
substances in emergency response (see
29 CFR 1910.120(a)). While the
petitioner is correct that CERCLA
regulations incorporate RCRA
hazardous wastes as part of the universe
of ‘‘hazardous substances,’’ (see petition
at 8 (citing 40 CFR 302.4(b)), the
universe of substances that give rise to
worker safety regulations is much
broader than RCRA hazardous wastes
(see 29 CFR 1910.120(a)). Petitioners
provide no support for the contention
that broadening the universe of waste
classified as RCRA-hazardous for
corrosivity would have had any impact
on the level of worker safety regulation
imposed at the WTC site.20
Finally, nothing submitted by
petitioners indicates that injury to
human health or the environment at the
WTC was related to improper treatment,
storage, transport, or disposal of solid
waste.21 Similarly, petitioners fail to
explain how the exposures they are
concerned about at the WTC site were
related to waste management activities.
The complexity and duration of
exposures and the lack of
documentation makes it infeasible to
distinguish the ambient air exposures
directly resulting from the initial
collapse of the towers (and ongoing
fires) from exposures potentially related
to waste management. Without any
20 Petitioners also argue that regulating
nonaqueous wastes with a pH between 11.5 and
12.5 would have made the first responders ‘‘more
motivated’’ to wear respirators. Petition at 23.
However, there is no support for this argument, and
EPA does not find this type of unsupported
suggestion sufficient to warrant regulation of a new
universe of waste as hazardous.
21 See 42 U.S.C. 6903(5); the definition of
hazardous waste includes, in part, solid wastes that
may ‘‘pose a substantial present or potential hazard
to human health or the environment when
improperly treated, stored, transported, or disposed
of, or otherwise managed.’’
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of materials may be used as aggregate,
with recently increasing emphasis on
use of recycled materials as aggregate
(e.g., glass, ceramic scrap, crushed
concrete; Marie and Quaisrawi, 2012;
Castro and Brito, 2013). However,
traditional aggregate is sand and gravel
from different types of rock. These
include silica sand, quartz, granite,
limestone and many others. There exists
a whole field of study dedicated to
understanding the properties and best
uses of different kinds of aggregate
materials in making concrete (PCA,
2003). Many of the materials used as
concrete aggregate include silica
minerals, and crystalline silica dust
exposure is a significant occupational
exposure concern, as it can cause
respiratory injury known as silicosis
(see 78 FR 56274, September 12, 2013).
In silicosis, inhaled crystalline silica
dust can cause fluid accumulation and
scarring of the lungs, which can reduce
respiratory capacity (American Lung
Association, ‘‘Learn about Silicosis.’’
retrieved from https://www.lung.org/
lung-health-and-diseases/lung-diseaselookup/silicosis/learn-aboutsilicosis.html). Various MSDS for ready
mix concrete (i.e., cement pre-mixed
with aggregate; just add water) identify
its crystalline silica content as, in one
case, 20–85%, in another, as 0–90%
(MSDS-Ready Mixed Concrete, April 14,
2011; MSDS-Lafarge Crushed Concrete,
March 1, 2011).
Many of the compounds and oxides
present in concrete are already regulated
by OSHA when they occur as airborne
dust. These include calcium silicates,
calcium hydroxide, calcium oxide, and
silicates. OSHA sets worker exposure
standards for these chemicals, known as
‘‘permissible exposure levels’’ (PELs;
see 29 CFR 1910.1000, tables Z–1 and
Z–3, in particular). The PEL for airborne
calcium oxide dust is 5 mg/m3; those for
calcium hydroxide and calcium silicate
are 15 mg/m3 for total dust, and 5 mg/
m3 for respirable dust; all measured as
8 hour time weighted average (TWA)
values.
There appear to be few studies
published in the peer-reviewed
scientific literature that have examined
the adverse health effects of exposure
specifically to concrete dust. OSHA
includes concrete dust among the
materials that would be covered under
their proposed regulation to revise the
PEL for respirable crystalline silica
(September 12, 2013; 78 FR 56274).
OSHA’s ‘‘Occupational Exposure to
Respirable Crystalline Silica—Review of
Health Effects Literature and
Preliminary Quantitative Risk
Assessment’’ (OSHA, 2013), developed
in support of its proposed regulation,
Continued
jstallworth on DSK7TPTVN1PROD with PROPOSALS
support for the proposition that
petitioners’ concerns are RCRA
concerns, there is similarly no
indication that amending the RCRA
regulations would address similar
concerns during future emergency
response events.
In sum, it is not possible to establish
a causal connection between the
potential corrosive properties of the
dust and the resultant injuries to those
exposed. The injuries documented at
the WTC in connection with potentially
harmful dust are not consistent with
injuries caused by corrosive material.
And finally, nothing submitted by
petitioners demonstrates that injury to
human health or the environment was
related to improper treatment, storage,
transport, or disposal of solid waste (i.e.
the petition does not demonstrate how
RCRA would or could address the
potential exposures alleged to be
hazardous).
b. Exposure to Concrete Dust
Petitioners also argue that corrosive
injury could result from the corrosive
properties of inhaled concrete dust
present in the air as a result of building
demolition by implosion. While the
petition illustrates the potential for
exposure to concrete dust from several
building demolitions, no documented
evidence of corrosive (or other) injury
from building demolition is provided.
The petition, therefore, fails to support
the argument that concrete dust should
be regulated as corrosive hazardous
waste.
Concrete is among the most common
construction materials used in the US.
It is a mixture of Portland cement (10–
15%) and aggregate (60–75%), with
water added (15–20%) to allow
hydration of the cement, which results
in its solidification (Portland Cement
Association, 2015). Concrete may
include some entrained air, and in some
cases, a portion of the Portland cement
may be replaced with combustion fly
ash, particularly coal fly ash. Cement is
made when lime (CaO), silica (SiO2),
alumina (Al2O3), iron oxide (Fe2O3), and
sulfate (SO3) are burned together in a
cement kiln at approximately 2600
degrees Fahrenheit (°F). The resulting
material, called ‘‘clinker’’, which
contains more complex mineral forms of
the ingredients, is ground to a fine
powder, and gypsum is added (CaSO42 H2O). This powder is cement; when
added to aggregate and hydrated, it
becomes concrete.
The other key component of concrete
is the aggregate. Both fine and coarse
aggregate are used, with their
proportions varying depending on the
particular use of the concrete. A variety
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identifies concrete production as among
the industries whose workers are likely
to be exposed to crystalline silica, and
notes that several of the health effects
studies OSHA relied on in its
assessment consider exposure to brick
or concrete dust as risk factors for
cancers caused by silica. The one study
that specifically considered the adverse
health effects of concrete dust exposure
to 144 concrete workers identified ‘‘. . .
mild chronic obstructive pulmonary
disease at respirable concrete dust levels
below 1 mg/m3, with a respirable
crystalline silica content of 10% (TWA
8 hr.).’’ (Meijer et al., 2001). Neither this
report, nor the OSHA silica rule risk
assessment document noted any
corrosive effects in workers exposed to
respirable concrete dust. Other OSHA
literature on concrete does identify
potential effects from exposure to
cement dust or wet concrete, ranging
from moderate irritation to chemical
burns (OSHA Pocket Guide on Concrete
Manufacturing; available online at
https://www.osha.gov/Publications/
3221_Concrete.pdf). However, neither
the petition nor information gathered
through the Agency’s independent
review of the literature provides
sufficient specificity for the Agency to
analyze whether this ‘‘Pocket Guide’’
supports the regulatory changes
requested. For example, it is not clear
whether any of the potential exposures
cited in the document involved actual
waste management scenarios. Given the
wide range of potential effects cited, it
is also not clear how the pH of the
material would relate to that range of
potential effects. Finally, as discussed
above, many of the compounds and
oxides present in concrete are already
regulated by OSHA, and, where OSHA
evaluated the risks of respirable
concrete dust as part of its silica rule, its
studies did not cite potential corrosive
effects of concrete dust as part of the
worker health concern the regulation
was focused on controlling.
OSHA also distinguishes inert, or
nuisance dust from fibrogenic dust,
such as crystalline silica or asbestos.
Nuisance dust is dust containing less
than 1% quartz, a form of crystalline
silica; the PEL values for nuisance dust
are also 15 mg/m3 total dust and 5 mg/
m3 for the respirable fraction, the same
PEL values as for calcium hydroxide
and calcium silicate dusts. (OSHA,
‘‘Chapter 1: Dust and its Control,’’
retrieved from https://www.osha.gov/
dsg/topics/silicacrystalline/dust/
chapter_1.html).22
22 Some of the exposures that petitioners are
concerned about may also be addressed by the
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In sum, while the petition alleges
harmful exposure to concrete dust from
several building demolitions, no
documented evidence of corrosive (or
other) injury from building demolition
is provided in the petition. Similarly,
the literature on this topic is limited,
and what limited literature does exist
does not demonstrate that the
petitioners’ requested regulatory
changes are warranted.
c. Exposure to Cement Kiln Dust
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The petition also argues that corrosive
injury could result from the corrosive
properties of Cement Kiln Dust (CKD).
However, the petition again fails to
provide any evidence demonstrating
that CKD would be appropriately
characterized as corrosive under RCRA.
CKD is an air pollution control
residue collected during Portland
cement manufacture. CKD was
exempted from regulation as hazardous
waste under RCRA pending completion
of a report to Congress providing an
evaluation of CKD properties, potential
hazards, current management, and other
information, by the Bevill Amendment
to RCRA (see 42 U.S.C. 6921(b)(3)(A)(i)
through (iii)). Following completion of
the Report, the EPA was required to
determine whether regulation of CKD as
hazardous waste is warranted. EPA
published its Report to congress on CKD
in 1993 (see docket for Report to
Congress on CKD, 1993), and published
a RCRA regulatory determination in
1995 (60 FR 7366, February 7, 1995).
Most CKD is managed on-site in nonengineered landfills, piles, and ponds,
which lack liners, leachate collection
and run-on/runoff controls. Wind-blown
CKD was cited as a concern in a number
of the damage cases resulting from CKD
management, but the Agency did not
identify any cases of corrosive injury
either to workers or the general public.
The risk assessment portion of the
Report examined possible direct
exposures to CKD via the air pathway
and found:
‘‘Quantitative modeling of air pathway
risks to people living near case-study
facilities indicated that wind erosion and
mechanical disturbances of on-site CKD piles
do not result in significant risks at nearby
residences via direct inhalation (e.g., central
tendency and high end risks estimates were
all less than 1 × 10¥11 increased individual
cancer risk at all five facilities modeled).
However, fugitive dust from on-site CKD
piles was estimated to be one of two
contributors in some cases to higher risk
National Ambient Air Quality Standards
(‘‘NAAQS’’) for particulate matter (40 CFR pt. 50)
and the National Emission Standards for Hazardous
Air Pollutants (‘‘NESHAPs’’) for asbestos (40 CFR
pt. 61, subpt. M).
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estimates for indirect exposure pathways
(which were primarily a result of direct
surface run-off from the CKD pile reaching an
agricultural field).’’ See docket for Report to
Congress on CKD, page 6–51.
Subsequent screening level modelling
found that windblown fugitive CKD
could cause violations of the Clean Air
Act fine particulate matter ambient air
quality standard (PM 10) at plant
boundaries and potentially at nearby
residences. The Agency’s regulatory
determination for CKD concluded that
existing fugitive dust controls were
ineffective in preventing fugitive
releases to the air, and determined that
additional controls were warranted due
to risks from fugitive air emissions and
runoff to surface waters in particular,
and also due to the potential for metals
to leach into groundwater. However, no
corrosive injuries were identified.
EPA published a proposed rule in
1999 (64 FR 45632, August 20, 1999) to
address these concerns. The proposal
focused in particular on improving
runoff controls from CKD piles, and
controlling fugitive dust releases, as
well as performance-based controls on
release to groundwater. Action on this
proposed rule has not been finalized.23
A number of new studies and data
reviews have been published since the
1999 proposal. These include a 2006
review of the effects of Portland cement
dust exposure by the United Kingdom
Health and Safety Executive (2005) and
studies published in the scientific
literature by van Berlo et al., (2009);
Isikli et al., (2006); Ogunbileje et al.,
(2013); Ogunbileje et al., (2014); Orman
et al., (2005); and Fatima et al., (2001).
While several of these studies note that
cement dust may be an irritant, or cause
contact dermatitis, none identified
corrosive injury resulting from
exposures to CKD or Portland cement
dust.
In sum, while the petition alleges
harmful exposure from CKD, the current
record before the Agency fails to
support that CKD should be regulated as
corrosive under RCRA.
B. Wastes That May Be Newly Regulated
Under the Requested Revisions
In the process of reviewing and
evaluating the petition, the Agency has
focused primarily on understanding and
responding to the issues raised by the
petition. While the petition focuses on
exposure and health effects issues, it
does not address the issue of the
23 While action on RCRA regulation has not yet
been finalized, EPA has established standards for
emissions of hazardous air pollutants from the
Portland cement manufacturing industry under
section 112 of the Clean Air Act. See, e.g., 40 CFR
pt. 63, subpt. LLL.
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impacts of the petition’s proposed
regulatory changes. At this point in its
review, the Agency has not developed a
systematic assessment of the types and
volumes of waste that might be newly
regulated as hazardous if the Agency
were to make the requested changes to
the corrosivity characteristic
regulations. However, interested
industry stakeholders have reviewed the
petition and sent the Agency their
estimates of the types and volumes of
wastes generated by their industries that
might become RCRA hazardous under
the petitioners’ proposed regulatory
revisions. The industry stakeholders
believe these wastes are currently
managed or reused safely, and that
regulating them as hazardous waste
would not produce a corresponding
benefit to worker, public or
environmental safety. The Agency has
not evaluated their estimates. While the
industry estimates are informal, they
may nonetheless provide at least a
qualitative, and, to some degree, a
quantitative estimate of waste that could
become newly regulated were the
Agency to make the requested
regulatory changes. See Letters of
September 30, 2015 and November 30
2015, from Wittenborn and Green. Also
see letter of September 4, 2015 from
Waste Management, and August 28,
2015 letter from the National Waste and
Recycling Association, in the
rulemaking docket for this document.
C. Determining What Waste Is
‘‘Aqueous’’
As a part of the argument regarding
regulation of solid corrosives, the
petition asserts that the current
corrosivity regulation is ambiguous,
particularly with regard to the definition
of the term ‘‘aqueous’’ as used in 40 CFR
261.22(a)(1) and that this causes
confusion in implementing the
regulation (see page 36 of the petition).
The petition also asserts that inclusion
of nonaqueous wastes within the scope
of the characteristic is consistent with
the approach taken by other federal
agencies, and would clarify this issue.
Method 9040 (in ‘‘Test Methods for
Evaluating Solid Waste, Physical/
Chemical Methods,’’ also known as SW–
846), which is incorporated into the
corrosivity characteristic regulation to
test for pH, is used to evaluate ‘‘aqueous
wastes and those multiphase wastes
where the aqueous phase constitutes at
least 20% of the total volume of the
waste’’. A number of EPA policy letters
on determining what wastes are
aqueous, referred to in the paragraph
below, do identify more than one
approach to distinguishing aqueous
from nonaqueous wastes. However,
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while petitioners are correct in noting
that the inclusion of nonaqueous wastes
within the scope of the corrosivity
characteristic would address this issue,
the Agency currently lacks data
demonstrating that regulation of
nonaqueous wastes as corrosive is
warranted under RCRA. Therefore any
clarification of the term ‘‘aqueous’’
should be appropriately tailored and
narrower than the change the petition
recommends.
The Agency did address this issue
when developing the corrosivity
characteristic definition in 1980. The
background document discusses how to
address the potential for analytical
interference in testing wastes that may
be suspensions or gel type material. At
least one commenter urged the Agency
to define the term ‘‘aqueous’’; however,
the Agency considered it as a testing
issue, and part of the waste generator’s
obligation to determine whether their
waste is RCRA hazardous (see 40 CFR
262.11). In 1985, the Agency published
the ‘‘paint filter liquids test’’ (PFT) for
identifying wastes containing free
liquids (Method 9095; 50 FR 18372,
April 30, 1985), and recommended its
use for distinguishing aqueous from
nonaqueous wastes. However, a year
later, EPA expressed concern about the
reliability and precision of the PFT for
separating liquids from solids when it
proposed the Toxicity Characteristic
Leaching Procedure (TCLP) test, and
instead proposed the use of pressure
filtration for separating solids from
liquids in that test (June 13, 1986; 51 FR
21681). In letters in 1989 (see docket for
letter to Mr. Wagner) and 1990 (see
docket for letter to Mr. Wyatt) the
Agency urged the use of the EP Tox test
pressure filtration procedure (Step 7.15;
Method 1310) for determining whether
wastes contained liquids, but also noted
that the paint filter test could be used
to show that a waste was liquid or
aqueous (i.e., a positive determination),
but not to show a waste was not liquid
or aqueous (i.e., a negative
determination). Letters in 1992 (see
docket for letters titled ‘‘ ‘Aqueous’ as
Applied to the Corrosivity
Characteristic’’ and ‘‘Alcohol-Content
Exclusion for the Ignitability
Characteristic’’) and 1993 (see docket for
letter to Mr. Parsons) noted that aqueous
wastes need not be liquid, and
identified suspensions, sols or gels for
which pH could be measured as subject
to the corrosivity characteristic. In a
1993 rule proposal updating SW–846,
the Agency stated that method 9095
could be used only to demonstrate that
a waste is aqueous, and that pressure
filtration is necessary to show that a
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waste is not aqueous (58 FR 46054,
August 31, 1993), and proposed to
revise the SW–846 guidance for
implementing the hazardous
characteristics to reflect this. However,
in finalizing these proposed revisions to
SW–846, the Agency considered
industry concerns that the proposed
revision to the characteristics
implementation guidance was
insufficiently clear and determined not
to revise the guidance. The Agency also
reiterated its assessment of PFT use: that
wastes producing no liquid using
Method 9095 should be subsequently
subjected to the more definitive method
for separating liquids from solids,
pressure filtration, as described in Step
7.2.7 of Method 1311 (the TCLP test; 60
FR 3089 and 3092, January 13, 1995).
As this issue is tangential to the
petitioners’ requests for regulatory
change, the Agency is proposing no
changes to its guidance at this time. The
Agency may further consider this issue
in the course of revising and updating
the SW–846 analytical methods in the
future.
D. Other Potentially Relevant Incidents
The purpose of this analysis is to
identify whether currently unregulated
wastes are causing harm that could be
effectively addressed by RCRA
regulation (‘‘damage cases.’’) The
petition presents several incidents the
petitioners consider to be wastemanagement damage cases. As
explained above, the evidence presented
in the petition does not appear to justify
a regulatory change. In addition to the
incidents presented by the petition, the
Agency sought to identify incidents of
corrosive injuries (i.e., chemical burns)
to workers or others that may be
attributable to exposure to corrosive
materials. In support of revisions to
RCRA’s regulatory definition of solid
waste, the Agency searched for damage
cases involving mishandling of wastes
at recycling facilities. Several of the 208
cases identified mishandling of
‘‘corrosive or caustic wastes’’ (primarily
at drum reconditioning operations); no
corrosive injuries to individuals were
reported, and the pH of the materials
was not identified, so it is not possible
to know whether these wastes were in
fact RCRA hazardous (EPA 2007; An
Assessment of Environmental Problems
Associated with Recycling of Hazardous
Secondary Materials). A 2015 update of
this study similarly identified incidents
at several drum reconditioning
operations in which caustic solutions
were mishandled, but no corrosive
injuries to workers were reported (EPA
2015, updating ‘‘An Assessment of
Environmental Problems Associated
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21307
with Recycling of Hazardous Secondary
Materials’’).
The Agency also reviewed a worker
accident database compiled by OSHA
(available by using key word ‘‘chemical
burn’’ at https://osha.gov/pis/imis/
accidentsearch.html). While a number
of chemical burns were identified in the
database, only a few contained enough
detail to know the pH of the material,
and all but one of the cases also
involved heated materials (most at 136–
295 °F, and one above 800 degrees °F),
making it difficult to attribute the
resultant injuries solely to the corrosive
properties of the materials. In the case
that did not involve heated material, an
employee got chemical burns when
exposed to effluent with pH estimated
to be 9.9 from a clarifier tank leak,
although the material was not
identified. In light of the pH value,
petitioners’ proposed regulatory change
would still not have captured this
material as characteristic waste.
The Agency also has information
describing a 1999 incident in which an
employee of a pulp and paper plant
apparently slipped and fell into black
liquor sludge at the edge of a concrete
pad on which it was being stored (see
docket materials related to Mr.
Matheny). The employee was knocked
unconscious, and, as he was working an
overnight shift, lay in the material for
several hours before being found by coworkers. He suffered chemical burns on
more than 50% of his body, and died
from his injuries. While this material
apparently contained enough absorbed
water to cause injury (although the
water content was not tested),
subsequent information indicated that it
passed the paint filter test, and so was
not considered to be an aqueous waste
under the RCRA corrosivity regulation,
and was therefore determined to be
outside the scope of the regulation. This
may be an instance in which a high
sodium concentration in the waste
interfered with testing its pH, as it
showed a pH reading of 12.45 when
tested directly, but with 10% water
added to the sample to reduce the
sodium interference, its pH was 12.95.
Rather than providing support for
expanding the definition of corrosivity
to include nonaqueous materials
however, the Agency believes this
damage case may illustrate the value of
clarifying the Agency’s approach to
determining what wastes are aqueous.
As mentioned above in section IV.2.C,
the Agency may further consider the
issue of testing which wastes are
aqueous in the course of revising and
updating the SW–846 analytical
methods in the future.
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V. EPA’s Conclusions and Rationale for
Tentative Denial of the Petition
In urging the Agency to expand the
scope of the RCRA corrosivity
characteristic, the petition advances a
number of arguments. However, the
petition fails in several ways to
demonstrate that a regulatory change is
warranted. While the petition
demonstrates that there has been human
exposure to materials identified by the
petition as being of concern, such as
concrete dust and CKD, it fails to
identify injuries of the type and severity
addressed by the RCRA corrosivity
characteristic that have resulted from
these exposures. The injuries that did
occur to those exposed to the WTC dust
have been attributed to the dust as a
whole, but cannot reliably be attributed
to any one property of the dust. While
WTC first responders and demolition
workers clearly have suffered adverse
health effects resulting from WTC dust
exposure, none of the published
research on this population reviewed by
the Agency has identified gross tissue
damage of the kind incorporated into
the RCRA and other regulatory and
guidance definitions of corrosivity (e.g.,
dissolving of skin proteins, combining
with cutaneous fats, or chemical burns).
WTC dust and concrete and cement dust
may be respiratory irritants, but do not
appear to be corrosives. Further, many
of the dusts identified as of concern
often exhibit pH values below the pH
11.5 value advocated in the petition.
And finally, the petition fails to
demonstrate that the hazards posed by
the WTC site dust could have been
reduced or controlled through RCRA
regulation.
The petition also argues that pH 11.5
is a widely used presumptive standard
for identifying material as corrosive, but
fails to identify that corrosive injury in
animal tests remains the fundamental
basis for corrosivity classification, and
that pH 11.5 is used as an optional
screening value that may be rebutted by
in vivo or various in vitro test data. The
use of pH 11.5 in these regulations and
guidances is fundamentally different
from how the pH 12.5 value is used in
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the RCRA corrosivity characteristic
regulation, and such use does not set a
precedent for defining corrosivity under
RCRA. Significant precaution can be
incorporated into these flexible
evaluation approaches without resulting
in unwarranted regulation, because the
presumption of corrosivity can be
rebutted. RCRA regulations do not
include such flexibility and are not
rebuttable; a waste meeting the
hazardous waste characteristics
regulatory criteria (and not otherwise
excluded from regulation) is RCRA
hazardous, which would trigger the
entire RCRA cradle-to-grave waste
management system. As noted in the
discussion previously, the RCRA
corrosivity characteristic reflects the
particular concerns of waste
management in the United States.
One of the Agency’s tentative
conclusions in evaluating the petition
and related materials is that while the
dusts identified by the petition as being
of concern are not corrosive materials,
they appear to be irritant materials. This
raises the question of whether the
Agency should consider a new
hazardous waste characteristic that
would identify and regulate irritant
wastes. However, this particular
question falls outside the scope of the
current petition. Moreover, there remain
significant questions about whether
RCRA waste management procedures
would address any of the exposures
identified in the petition.
Finally, the hazardous characteristics
regulations are not the only RCRA
authority the Agency has for addressing
risks related to waste management. If
wastes generated by a particular
industry, or a particular waste generated
by a number of industries, were
identified as posing corrosive risks to
human health or the environment that
could be effectively addressed by RCRA
regulation, the Agency could initiate a
hazardous waste listing rulemaking to
regulate that waste. Given the lack of
evidence to demonstrate that a
wholesale change of the pH threshold in
the corrosivity regulation is warranted,
the listing approach would effectively
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address a specifically identified waste
without running the risk of overincluding wastes that have a pH greater
than 11.5 without demonstrating
corrosive properties.24
VI. Request for Public Comment on
EPA’s Tentative Denial of the Petition
As part of this document, the Agency
is soliciting public comment and data
and other information on the issues
raised by the petition. These include
information on possible health impacts
of the current corrosivity regulation (if
any), as well as health benefits (if any)
that may be anticipated were the
Agency to grant the petition’s proposed
regulatory changes. Further, the Agency
is requesting public comment on any
other issues raised by this tentative
decision to deny the petition, as well as
additional information on the types and
amounts of waste that may be newly
regulated, and the potential cost of such
management, were the agency to grant
the proposed regulatory changes.
Stakeholders intending to provide
comments or information to the Agency
in this matter are encouraged to review
the petition and its supporting
documents in their entirety to ensure
that they identify any issues not
discussed here that they may find of
interest.
VII. References
The full bibliography for references
and citations in this action can be found
in the docket as a supporting document.
List of Subjects in 40 CFR Part 261
Environmental protection,
Characteristic of corrosivity, and
Characteristics of hazardous waste.
Dated: March 30, 2016.
Mathy Stanislaus,
Assistant Administrator, Office of Land and
Emergency Management.
[FR Doc. 2016–08278 Filed 4–8–16; 8:45 am]
BILLING CODE 6560–50–P
24 In particular instances, RCRA 7003 authority
can also be used to address situations posing threats
of imminent and substantial endangerment from
waste mismanagement.
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[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Proposed Rules]
[Pages 21295-21308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08278]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 261
[EPA-HQ-RCRA-2016-0040; FRL9944-67-OLEM]
Hazardous Waste Management System; Tentative Denial of Petition
To Revise the RCRA Corrosivity Hazardous Characteristic
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notification of tentative denial of petition for rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
responding to a rulemaking petition (``the petition'') requesting
revision of the Resource Conservation and Recovery Act (RCRA)
corrosivity hazardous waste characteristic regulation. The petition
requests that the Agency make two changes to the current corrosivity
characteristic regulation: revise the regulatory value for defining
waste as corrosive from the current value of pH 12.5, to pH 11.5; and
expand the scope of the RCRA corrosivity definition to include
nonaqueous wastes in addition to the aqueous wastes currently
regulated. After careful consideration, the Agency is tentatively
denying the petition, since
[[Page 21296]]
the materials submitted in support of the petition fail to demonstrate
that the requested regulatory revisions are warranted, as further
explained in this document. The Agency's review of additional materials
it identified as relevant to the petition similarly did not demonstrate
that any change to the corrosivity characteristic regulation is
warranted at this time.
The Agency is also soliciting public comment on this tentative
denial and the questions raised in this action.
DATES: Comments must be received on or before June 10, 2016.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2016-0040, 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://www.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: Gregory Helms, Materials Recovery and
Waste Management Division, Office of Resource Conservation and
Recovery, (5304P), Environmental Protection Agency, 1200 Pennsylvania
Avenue NW., Washington, DC 20460; telephone number: 703-308-8855; email
address: corrosivitypetition@epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. General Information
A. Does this action apply to me?
B. What action is EPA taking?
C. What is EPA's authority for taking this action?
D. What are the incremental costs and benefits of this action?
III. Background
A. Who submitted a petition to the EPA and what do they seek?
B. What is corrosivity and why are corrosive wastes regulated as
hazardous?
C. What approaches are used in testing and evaluation of
materials for corrosivity?
IV. Review and Evaluation of the Petition and Relevant Information
A. Review of Requested Regulatory Revisions and Supporting
Information
1. Request to Lower RCRA's Corrosivity Characteristic pH
Threshold to 11.5
a. History of RCRA's Corrosivity Regulation
b. Other Corrosivity Standards
2. Request To Include Nonaqueous Corrosive Materials Within the
Scope of RCRA's Corrosivity Vharacteristic
a. Exposure to World Trade Center 9/11 Dust
b. Exposure to Concrete Dust
c. Exposure to Cement Kiln Dust
B. Wastes That May Be Newly Regulated Under Requested Revisions
C. Determining What Waste is ``aqueous''
D. Other Potentially Relevant Incidents
V. EPA's Conclusions and Rationale for Tentative Denial of the
Petition
VI. Request for Public Comment on EPA's Tentative Denial of the
Petition
VII. References
I. Executive Summary
This action responds to a rulemaking petition requesting revision
of the Resource Conservation and Recovery Act (RCRA) corrosivity
hazardous waste characteristic regulation (see 40 CFR 261.22). The
petition requests that the Agency make two changes to the current
corrosivity characteristic regulation: (1) Revise the regulatory value
for defining waste as corrosive from the current value of pH 12.5, to
pH 11.5; and (2) expand the scope of the RCRA corrosivity definition to
include nonaqueous wastes in addition to the aqueous wastes currently
regulated. The petition argues that the regulatory pH value should be
revised to pH 11.5 because information supporting this value was, in
the petitioners' view, inadequately considered in developing the
regulation and because petitioners allege that this value is widely
used as a threshold for identifying corrosive materials. The petition
further argues that corrosive properties of inhaled dust caused injury
to first responders and others at the World Trade Center (WTC) disaster
of September 11, 2001, and that such dusts should be regulated as
corrosive hazardous waste under RCRA.
After careful consideration, and as described in greater detail
below, the Agency is tentatively denying the petition, since the
materials submitted in support of the petition fail to demonstrate that
the requested regulatory revisions are warranted. Where used in other
regulatory frameworks, the pH 11.5 value is either optional or a
presumption that may be rebutted by other data, a use very different
than the way pH is used in the RCRA corrosivity regulation.
Moreover, the dust to which 9/11 first responders and others were
exposed was a complex mixture of pulverized concrete, gypsum, metals,
organic and inorganic fibers, volatile organic compounds, and smoke
from the fires at the site. No single property of the dust can be
reliably identified as the cause of the adverse health effects in those
exposed to the WTC dust. In addition, the injuries that were suffered
by those exposed to the WTC dust did not appear to include corrosive
injuries--i.e., the serious destruction of human skin or other tissues
at the point of contact. Persons exposed to simpler dusts of concern to
the petition (Cement Kiln Dust and concrete dust) similarly did not
appear to experience corrosive injuries. Finally, the petition does not
show that waste management activities resulted in the exposures of
concern, nor does it identify how the proposed regulatory changes would
address these exposures. The Agency's evaluation of additional
materials it identified as relevant to the petition similarly did not
demonstrate that any change to the corrosivity characteristic
regulation is warranted at this time. The Agency is therefore
tentatively denying the petition, and is also soliciting public comment
on this tentative denial and the questions raised in this action.
II. General Information
A. Does this action apply to me?
The Agency is not proposing any regulatory changes at this time.
Persons that may be interested in this tentative denial of the
rulemaking petition include any facility that manufactures, uses, or
generates as waste, any materials (either aqueous or nonaqueous) with a
pH 11.5 or greater, or 2 or lower.
B. What action is EPA taking?
Under Subtitle C of RCRA, the EPA has developed regulations to
identify solid wastes that must then be classified as hazardous waste.
Corrosivity is one of four characteristics of wastes that may cause
them to be classified as RCRA hazardous. The Agency defines which
wastes are hazardous because of their corrosive properties at 40 CFR
261.22. On September 8, 2011, the non-governmental organization (NGO)
Public Employees for Environmental Responsibility (PEER) and Cate
Jenkins, Ph.D.,\1\ submitted a rulemaking petition to the EPA seeking
changes to the current regulatory definition of
[[Page 21297]]
corrosive hazardous wastes under RCRA. The petitioners express concerns
about potentially dangerous exposures to workers and the general public
from dusts that may potentially be corrosive. In particular, the
petition is concerned about inhalation exposures, primarily to concrete
or cement dust, which may occur in the course of manufacturing or
handling of cement, and during building demolitions. To address these
concerns, the petition urges the Agency to make two changes to the
current regulatory definition of corrosive hazardous waste: (1) Revise
the pH regulatory value for defining waste as corrosive from the
current value of pH 12.5, to pH 11.5; and (2) expand the scope of the
RCRA corrosivity definition to include nonaqueous wastes in addition to
the aqueous wastes currently regulated.
---------------------------------------------------------------------------
\1\ Dr. Jenkins is an EPA employee.
---------------------------------------------------------------------------
With this action, the Agency is responding to requests in the
petition by publishing its evaluation of the petition and supporting
materials, and by requesting public comment on the topics raised by the
petition. A detailed discussion of the petition and the issues
identified by the Agency on which we are soliciting public input are
discussed later in this document. The Agency is soliciting information
and other input on issues related to the scope of the changes proposed
in the petition. This may include information on the adverse health
effects, if any, that may be avoided if the Agency were to grant the
requested regulatory changes. It may also include information on
changes in the universe of waste (including type of waste and volume)
that may become regulated as corrosive hazardous waste if the Agency
were to make the requested changes, including potentially affected
industries and the possible impact of such regulatory changes.
C. What is EPA's authority for taking this action?
The corrosivity hazardous waste characteristic regulation was
promulgated under the authority of Sections 1004 and 3001 of the RCRA,
as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA),
42 U.S.C. 6903 and 6921. The Agency is responding to this petition for
rulemaking pursuant to 42 U.S.C. 6903, 6921 and 6974, and implementing
regulations 40 CFR parts 260 and 261.
D. What are the incremental costs and benefits of this action?
As this action proposes no regulatory changes, this action will
have neither incremental costs nor benefits.
III. Background
A. Who submitted a petition to the EPA and what do they seek?
On September 8, 2011, petitioners PEER and Cate Jenkins, Ph.D.,
sent the EPA a rulemaking petition seeking revisions to the RCRA
hazardous waste corrosivity characteristic definition (see 40 CFR
261.22). On September 9, 2014, the petitioners filed a petition for
Writ of Mandamus, arguing that the Agency had unduly delayed in
responding to the 2011 petition, and asking the Court to compel the
Agency to respond to the petition within 90 days. The Court granted the
parties' joint request for a stay of all proceedings until March 31,
2016.
The petition seeks two specific changes to the 40 CFR 261.22(a)
definition of a corrosive hazardous waste:
1. Reduction of the pH regulatory value for alkaline corrosive
hazardous wastes from the current standard of pH 12.5 to pH 11.5; and
2. Expansion of the scope of the RCRA hazardous waste corrosivity
definition to include nonaqueous wastes, as well as currently regulated
aqueous wastes.
The Agency is responding to this RCRA rulemaking petition in
accordance with 40 CFR 260.20(c) and (e).
B. What is corrosivity and why are corrosive wastes regulated as
hazardous?
The term ``corrosivity'' describes the strong chemical reaction of
a substance (a chemical or waste) when it comes into contact with an
object or another material, such that the surface of the object or
material is irreversibly damaged by chemical conversion to another
material, leaving the surface with areas that appear eaten or worn
away. That is, the corrosive substance chemically reacts with the
material such that the surface of the contacted material is dissolved
or chemically changed to another material at the contact site. Chemical
reaction and damage at the contact site may continue as long as some
amount of the unreacted corrosive substance remains in contact with the
material. In situations in which corrosive substances are being handled
by people, key risks of corrosive damage are injury to human tissue,
and the potential to damage metal storage containers (primarily steel)
that may hold chemicals or wastes. Corrosive substances cause obvious
damage to the surface of living human tissue by chemically reacting
with it, and in the process, destroying it. The strength of the
corrosive material and the duration of exposure largely determine the
degree or depth of injury. Corrosive injury is at the extreme end of a
continuum of effects of dermal and ocular chemical exposure, and
results in serious and permanent damage to skin or eyes.\2\ Corrosive
injury is distinguished from irritation of the skin or eyes based on
the severity and permanence of the injury, with irritation generally
being reversible (see Globally Harmonized System for the Classification
and Labelling of Chemicals (``GHS'' or ``GHS guidance'') Chapters 3.2
and 3.3; Organization for Economic Cooperation and Development (OECD)
Test Methods 404 (rev. 2015) and 405 (rev. 2012); Grant and Kern 1955).
---------------------------------------------------------------------------
\2\ As with thermal burns, chemical burns may heal over time,
but will typically leave scarring, or in more severe cases, may
affect the function of the exposed body part. Ocular corrosive
injury may lead to blindness or other vision problems.
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In 1980, EPA identified ``corrosivity'' as a characteristic of
hazardous waste because it determined that improperly managed corrosive
wastes pose a substantial present or potential danger to human health
and the environment (see Background Document for Corrosivity, May 1980;
hereafter referred to as Background Document, 1980). While other
international and domestic regulatory programs address corrosivity in
other contexts (e.g. exposure to non-waste hazardous substances), RCRA
is the United States' primary law governing the management of solid and
hazardous waste from cradle to grave. Consideration of RCRA's
corrosivity characteristic therefore requires consideration of whether
a particular threat of harm is one that would be addressed within
RCRA's waste management framework.
When in contact with steel, corrosive substances (primarily acids)
can react with the iron to change its chemical form and weaken it,
potentially leading to a hole in the container and a release of the
corrosive substance to the environment. In a waste management setting,
extreme pH substances may also mobilize toxic metals, react with other
co-disposed wastes (e.g., reaction of acids with cyanides, to form
hydrogen cyanide gas), or change the pH of surface water bodies,
causing damage to fish or other aquatic populations. However, the
Agency focused primarily on the potential for injury to humans when it
initially developed the corrosivity regulation:
``Corrosion involves the destruction of both animate and
inanimate surfaces.'' (Background Document page 3, 1980)
. . .
``Wastes exhibiting very high or low pH levels may cause harm to
persons who come
[[Page 21298]]
in contact with the waste. Acids cause tissue damage by coagulating
skin proteins and forming acid albuminates. Strong base or alkalis,
on the other hand, exert chemical action by dissolving skin
proteins, combining with cutaneous fats, and severely damaging
keratin.'' (Background Document page 5, 1980)
. . .
``The Agency has determined that corrosiveness, the property
that makes a substance capable of dissolving material with which it
comes in contact, is a hazardous characteristic because improperly
managed corrosive wastes pose a substantial present or potential
danger to human health and the environment.'' (Background Document
page 1, 1980)
In the previous discussion, the corrosivity regulation background
document describes corrosives as having a severe effect on human
tissue. Dissolving of skin or other tissue proteins by chemicals, and
chemically combining with fats (stored body fat in adipose or other
human tissue) are chemical processes which clearly destroy the surface
of human tissue and may penetrate beyond surface layers of skin. These
adverse effects on skin have also been described by the term ``chemical
burns'' because of their similarity to burns caused by fire or other
sources of intense heat.
Highly acidic and alkaline (basic) substances comprise a large part
of the universe of corrosive chemicals. The strength of acids and
alkalies is measured by the concentration of hydrogen ions, usually in
a water solution of the acid or alkali. The hydrogen ion concentration
is expressed as ``pH'', which is a logarithmic scale with values
generally ranging from zero to 14. On the pH scale, pH 7 is the mid-
point, and represents a neutral solution. That is, it is neither acidic
nor basic. Solutions having pH values of less than 7 are acidic while
solutions with pH greater than 7 are basic. As pH values move toward
the extremes of the scale (i.e., 0 and 14), the solution becomes
increasingly acidic or alkaline.
Under current RCRA regulations, aqueous wastes having pH 2 or
lower, or 12.5 or higher, are regulated as hazardous waste. Liquid
wastes that corrode steel above a certain rate are also classified as
corrosive under RCRA. These values were set in consideration of wastes'
potential to cause injury to human tissue as well as waste management
issues, as discussed in greater detail in section IV below (Background
Document, 1980).
Federal regulatory agencies other than the EPA also regulate human
exposure to corrosive materials. These include the Occupational Safety
and Health Administration (OSHA), the Department of Transportation
(DOT), and the Consumer Product Safety Commission (CPSC). Further,
international organizations have also made recommendations about
controlling human exposure to corrosive chemicals or wastes. These
include the United Nations Guidance on the Transport of Dangerous Goods
(UNTDG), the GHS, the International Labor Organization (ILO), and the
Basel Convention on the Transboundary Movement of Hazardous Waste
(Basel, or the Basel Convention).
C. What approaches are used in testing and evaluation of materials for
corrosivity?
Before 1944, there was no systematic method for evaluating the
dermal toxicity and corrosive or irritating properties of chemicals on
human tissue. Advances in chemistry and medicine in the mid-20th
century led to development of a broader range of therapeutic, cosmetic,
and personal care products (e.g., soaps, shampoo, hair conditioner) and
prompted the need to move beyond an anecdotal collection of largely
qualitative information on corrosivity to a systematic approach for
determining the potential for irritation or corrosivity. Scientists
working for the U.S. Food and Drug Administration (FDA) were the first
investigators to develop an approach that tried to be objective and
quantitative, so that differences in the impact of different chemicals
or formulations could be systematically identified (Draize et al. 1944,
Draize 1959). Their testing approach involved application of chemicals
or formulations directly to animal skin or eyes (primarily rabbits),
with the results graded by the severity of the adverse effect and the
duration of exposure required to produce those adverse effects.\3\ The
skin and eyes of the test animals were assumed to be similar to that of
humans, and results were either used directly to classify chemicals or
sometimes, for less irritating materials, were confirmed by testing on
human subjects. The pH of chemicals or formulations was also correlated
with the occurrence of adverse effects on test animals in much of the
basic research that occurred during this time period (Hughes, 1946;
Friedenwald et al., 1946; Grant and Kern, 1955; Grant, 1962). Testing
for pH is a routine and easily performed test for many materials
(although it does require the presence of water or another source of
hydrogen ions in the sample). However, pH testing of very high
concentration acids or alkalies can be problematic, and high
concentrations of sodium ions in solution can cause analytical
interferences (Lowry et al., 2008).
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\3\ Testing on live animals is described as in vivo testing.
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The animal testing approach described above evolved to become the
standard method for assessing the corrosivity of chemicals to humans
(Weltman et al., 1965; Balls et al., 1995; OECD Methods 404 and 405).
Variability in test results and some differences in effects on humans
were identified as the tests were further developed and refined.
Sources of variability included different results when chemicals were
applied to different areas of skin, and different reactions of animal
eyes as compared with those of humans, among others (Weil and Scala,
1971; Phillips et al., 1972; Vinegar, 1979). One key approach to
facilitating greater reproducibility (precision) in testing was a
standardized grading scheme published by the FDA (Marzulli, 1965). A
version of this testing approach has also been adopted as guidance by
the OECD to provide an international approach to chemical
classification, with the goal of facilitating international commerce
(see OECD Methods 404 \4\ and 405). Over the intervening time,
significant amounts of animal test data have been collected and used
for classifying chemicals or formulations as corrosive.
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\4\ OECD Methods 404 and 405 continue to rely on live animal
testing as the definitive test method for assessing corrosivity and
irritation potential of chemicals and formulations. The current
version of Method 404 (2015) and Method 405 (2012) allow for use of
other tests in a weight-of-evidence approach. However, if results
are inconclusive, live animal testing is used as a last resort.
Dermal corrosion is defined as ``. . . visible necrosis through the
epidermis and into the dermis. . .''. For corrosivity to the eye,
``A substance that causes irreversible tissue damage to the eye . .
.''
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However, concern about testing for corrosivity on live animals has
been expressed within the scientific community (Balls et al., 1995) and
by non-government animal welfare advocacy organizations (Animal
Justice, ``Medical Testing on Animals: A Brief History'' retrieved from
https://www.animaljustice.ca/blog/medical-testing-animals-brief-history/
). The result of this concern has been the development of alternative,
in vitro testing approaches,\5\ intended to reduce reliance on in vivo
animal testing. Among the first such tests was a commercially developed
test named the ``Corrositex[supreg]'' test in 1993 (InVitro
International, ``What is Corrositex?'' 2007, retrieved from https://
www.invitrointl.com/products/
[[Page 21299]]
corrosit.htm). In this test, a ``bio-barrier'' material is placed in a
tube such that it blocks the tube, which contains an indicator
solution. The test material is placed on the collagen plug, and
breakthrough to the indicator solution is timed.\6\ Other somewhat
similar testing approaches have also been developed, which use cultured
human skin cells or skin from a laboratory animal that has been
euthanized. Extensive work to validate these new testing approaches
against the existing data has been done (Barratt et al., 1998; Kolle et
al., 2012; Deshmukh et al., 2012; Vindarnell and Mitjans, 2008), and
several are now considered validated to some degree (see OECD Tests
430, 431, 435, 437, 438). A number of studies applying chemical
quantitative structure/activity relationships (QSAR) to assessing
chemical corrosivity have also been published (Hulzebos, et al., 2003;
Verma and Matthews, 2015a; Verma and Matthews, 2015b). However, these
new tests are not yet fully integrated into the evaluation and
classification guidance and regulations used in the U.S. and
internationally, and most guidance and regulations rely first on
existing animal and human data. The new testing approaches and QSAR
analysis are primarily used as alternatives to reduce to a minimum the
use of live animal testing on new, untested chemicals or formulations.
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\5\ In vitro, literally translated means ``in glass''. In this
context it means testing in a laboratory vessel, rather than using a
live animal.
\6\ The Agency has added this test to its analytical chemistry
technical guidance for evaluating waste, as Method 1120. While at
one time the Agency considered revising the corrosivity regulation
to rely on this test, no regulatory proposal was ever published.
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IV. Review and Evaluation of the Petition and Relevant Information
A. Review of Requested Regulatory Revisions and Supporting Information
This action is based on the petition and its supporting
materials,\7\ the Agency's review and evaluation of this information,
information submitted by other stakeholders, and relevant information
compiled by the Agency. All materials and information that form the
basis for this decision are available in the public docket supporting
this action.
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\7\ In reviewing the petition the Agency identified a number of
statements and/or assertions that are factually incorrect or
inaccurate or are otherwise misstatements. The Agency has not
responded to all such statements, but rather has limited its
responses to those related to the substantive discussion of the
petition's requests and supporting arguments in the petition. The
petition also alleges certain instances of fraud; while the Agency
denies all such allegations, the Agency is not addressing those
allegations in this document because they are not relevant to
considerations about whether a regulatory change to the current RCRA
corrosivity characteristic is warranted.
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The petition presents a number of arguments and information
supporting the requested revisions to the RCRA corrosivity regulation.
The petition's arguments and supporting information are summarized and
discussed below.
The petition seeks two specific changes to the 40 CFR 261.22(a)
definition of a corrosive hazardous waste:
1. Reduction of the pH regulatory value for alkaline corrosive
hazardous wastes from the current standard of pH 12.5 to pH 11.5; and
2. Expansion of the scope of the RCRA hazardous waste corrosivity
definition to include nonaqueous wastes, as well as currently regulated
aqueous wastes.
In evaluating the petition, the Agency considered whether these
specific changes are warranted based on the evidence in the petition
and additional, relevant information compiled by the Agency.\8\
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\8\ While the petition requests the inclusion of nonaqueous
wastes in the corrosivity characteristic regulation, the petition
does not provide any information regarding nonaqueous acidic wastes
having pH 2 or lower. The petition appears to only be alleging harm
from nonaqueous wastes in the upper pH, alkaline range. As such, the
Agency has similarly focused its analysis. To the extent that
petitioners allege the need to include nonaqueous acidic wastes
having pH 2 or lower as part of the RCRA corrosivity characteristic
regulation, additional information should be submitted in the
comment period for the Agency's evaluation.
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1. Request To Lower RCRA's Corrosivity Characteristic pH Threshold to
11.5
The current RCRA corrosivity regulation classifies aqueous waste
having pH 12.5 or higher as corrosive hazardous waste (40 CFR
261.22(a)(1)). The petition seeks revision of the pH regulatory value
for alkaline corrosive hazardous wastes from the current standard of pH
12.5 to pH 11.5.\9\
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\9\ The corrosivity characteristic potentially applies to any
aqueous RCRA solid waste, unless exempted from hazardous waste
regulation. In 2011, more than 8 million tons of waste were
regulated as corrosive hazardous waste (see RCRA Biennial Report for
2011, Exhibit 1.8).
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In urging the Agency to make this regulatory change, the petition
argues that a pH value of 11.5 is widely used in other U.S. regulatory
programs and guidances, as well as in global guidance. The petition
also argues that in promulgating the final regulation in 1980, the EPA
did not give appropriate weight to guidance by the ILO on corrosivity
that the petition considers definitive for identifying corrosive
materials; and therefore expresses the belief that the current standard
is not adequately protective of human health and the environment.\10\
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\10\ Petitioners allege that EPA misrepresented the pH levels
cited in a 1972 ILO encyclopedia. As mentioned above at footnote 7,
the Agency denies all such allegations. However, the Agency is not
addressing those allegations in this document because they are not
relevant to considerations about whether a regulatory change to the
current RCRA corrosivity characteristic is currently warranted.
While the petitioners place great weight on the mention of a pH of
11.5 in the 1972 ILO encyclopedia, that encyclopedia was one among
multiple factors considered in developing the regulation and it is
in no way binding on the Agency. No challenge to the 1980 regulation
was filed, and the statute of limitations to challenge that 1980
regulation has long since passed.
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a. History of RCRA's Corrosivity Regulation
The corrosivity regulation was promulgated on May 19, 1980 as part
of a broad hazardous waste regulatory program that was finalized that
day (45 FR 33084, 33109, and 33122). As no timely challenges to the
final corrosivity regulation were filed in the appropriate court
pursuant to 42 U.S.C. 6976(a), the rule, including the regulatory
thresholds used to define solid waste as exhibiting the hazardous
characteristic of corrosivity, has been in effect since 1980.
The record supporting the May 19, 1980 rulemaking for the
corrosivity hazardous characteristic includes three Federal Register
actions (an Advanced Notice of Proposed Rulemaking (ANPRM), a Proposed
Rule and a Final Rule), draft and final technical background documents,
and comments from and Agency responses to a range of stakeholders.
Review of these materials identifies the Agency's proposed and final
approaches to this regulation, as well as public views on the proposed
regulation.
In the 1977 ANPRM, the Agency discussed waste corrosivity only with
regard to the potential for waste to damage storage containers, which
could result in waste release to the environment. The Agency solicited
public comments on this approach to regulation of corrosive wastes (42
FR 22332, May 2, 1977).
Following publication of the ANPRM, the Agency released several
draft versions of the regulations under development, including the
corrosivity regulation. Draft documents dated September 14, 1977,
November 17, 1977, and September 12, 1978 can be found in the
rulemaking docket for the 1980 regulation, as well as several comments
on these drafts. The September 1977 draft included a preliminary
corrosivity definition based on pH values outside the range of pH 2-12,
applied to liquid waste or a
[[Page 21300]]
saturated solution of non-fluid waste. The November 1977 draft would
have defined as hazardous those wastes having a pH outside the range of
pH 3-12, and would have potentially applied to aqueous wastes and
nonaqueous wastes when the latter was mixed with an equal weight of
water. In a September 1978 draft, corrosive wastes would have been
defined as aqueous wastes having a pH outside the range of pH 3-12.
In the 1978 proposed regulations, the Agency proposed to identify
corrosive hazardous waste based on the pH of aqueous solutions, and an
evaluation of the rate at which a liquid waste would corrode steel.
Waste aqueous solutions having a pH less than or equal to pH 3, or
greater than or equal to pH 12 were proposed to be classified as RCRA
corrosive hazardous waste (43 FR 58956, December 18, 1978). Concerns
identified by the Agency in the proposal included the ability of
corrosives to mobilize toxic metals, corrode waste storage containers,
corrode skin and eyes, and cause damage to aquatic life (by changing
the pH of waterbodies). The background support document for the
proposal elaborated on EPA's concerns about corrosion to skin, noting
that the regulation was intended to include as corrosive those waste
``. . . substances that cause visible destruction or irreversible
alteration in human skin tissue at the site of contact.'' (Draft
Background Document on Corrosiveness page 5, December 15th, 1978;
hereafter referred to as ``Draft Background Document, 1978''). The pH
of wastes was used as the basis of the regulation because it could be
used to evaluate both skin damage and toxic metal mobility (see Draft
Background Document pages 13 and 14, 1978). The Agency also expressed
some concern about solid corrosives, and requested that the public
provide information on the potential hazards of solids that may be
corrosive.
The Agency received many comments on the regulatory proposals made
that day, as significant parts of the RCRA program were proposed. The
comments received addressed a number of topics raised by the proposal,
including the proposed corrosivity regulation.
The majority of public comments urged expanding the range of pH
values that would not be classified as corrosive. For example, some
commenters urged the Agency to raise the alkaline range pH regulatory
value to either pH 12.5 or 13, in part, because they believed the
proposed pH value would have resulted in lime-stabilized wastes, which
when treated were otherwise non-hazardous, being classified as
hazardous because of their pH. These commenters also believed treatment
to de-characterize these wastes (i.e., make them less corrosive) would
potentially allow the mobilization of toxic metals that were stable in
the waste at the higher pH. The Agency generally agreed with these
concerns and set a final alkaline range pH value of 12.5 and above for
defining corrosive hazardous waste.\11\ The petition reflects concern
about this as part of the basis for the pH regulatory value, and argues
that it is no longer necessary or a valid basis for the regulation
because of other changes in the regulations of wastewater treatment
sludges in particular. However, there is no documentation in the
petition supporting these assertions. High alkalinity materials
continue to be used as an important option in the treatment of metal-
bearing wastes to reduce metal mobility (see LDR Treatment Technology
BDAT Background Document pages 101-109, January 1991; Chen et al.,
2009; Malvia and Chaudhary, 2006).
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\11\ The pH of wastes is determined using EPA Method 9040.
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b. Other Corrosivity Standards
Among the arguments made by the petition is the assertion that a pH
value of 11.5 is widely used in other U.S. regulatory programs and
guidances, as well as in global guidance.\12\ This assertion, however,
is largely inaccurate and fails to support a regulatory change for
several reasons. As discussed in more detail below, the classification
of materials as corrosive and use of pH 11.5 in this process is far
more complicated than portrayed by the petition. Moreover, even where
pH 11.5 is incorporated as a presumptive benchmark in other regulatory
programs or guidance (for example, pH 11.5 is identified by the 1972
ILO Encyclopedia of Occupational Safety and Health (``1972 ILO
Encyclopedia'')), that fact alone is insufficient to demonstrate that
the same benchmark is appropriate for regulation of hazardous waste
under RCRA. While it is useful to consider information on how
corrosivity is measured and regulated by other organizations, EPA is
not bound under RCRA to rely on voluntary standards or the decisions of
other regulatory agencies, or even regulations or guidance developed by
EPA under other statutory authorities.
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\12\ Use of a pH value of 11.5 was apparently suggested by
Hughes (1946) and Grant (1962) based on empirical observations of
the effects of sodium hydroxide solutions on the eyes of test
animals. It is not clear whether the 11.5 value was systematically
assessed to determine its applicability to other alkaline solutions
or to dermal exposures.
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The corrosive potential of materials is addressed by a number of
national and international organizations. Among the organizations that
address corrosivity, the following rely on information from human
exposure, animal tests, or other tests (as discussed previously) as the
primary determinative factor in classifying a material as corrosive,
rather than relying on pH: The UNTDG, the GHS, the DOT, the OSHA, the
U.S. National Institute for Occupational Safety and Health (NIOSH), the
CPSC and U.S. EPA regulations of pesticides under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).13 14
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\13\ These organizations rely primarily on human experience
(reported case studies) and the results of animal testing, including
test results that may be reported in scientific publications or from
other sources. Recently developed in-vitro tests are beginning to
replace animal testing.
\14\ The FDA does not directly regulate cosmetics and related
products based on their corrosive potential. FDA does require that
the safety of cosmetic products be adequately substantiated before
they are sold, unless they bear a warning label noting that the
safety of the product has not been determined (see 21 CFR 740.10)
While the original protocol for testing on animals resulted from its
needs, and was developed by FDA scientists (Draize et al., 1944,
1959), the FDA does not specify required testing for cosmetics.
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The UNTDG guidelines include criteria for classifying materials as
corrosive, and reference the OECD test methods for applying the UNTDG
corrosivity criteria. Classification as corrosive under the UNTDG
guidelines is based on full thickness destruction of intact skin.
(UNTDG Model regulations Chapter 2.8, Rev. 18, 2013, and UNTDG test
methods Section 37, Rev. 5 2009).
In 2003, the UN published its GHS guidance, which addresses
corrosivity, among other chemical hazards. The 2013 version of GHS
(Rev. 5, 2013) addresses chemical corrosivity to skin and eyes in
separate sections of the guidance. For classification as corrosive to
skin (GHS Chapter 3.2), a material must result in skin tissue
destruction. The GHS tiered evaluation approach (Figure 3.2.1) relies
primarily on available human data (case studies) for making a
corrosivity determination, then animal data, and references the use of
material pH in the third tier of the evaluation.
The UN expert groups responsible for developing the UNTDG and GHS
guidances have been working for a number of years (since at least 2010)
to harmonize the corrosivity definitions of the two guidance documents.
As of April 2015, there was no consensus on how to define corrosivity,
and work of the two groups is ongoing (see: UN
[[Page 21301]]
working document ST/SG/AC.10/C.3/2015/21 and ST/SG/AC.10/C.4?2015/2,
April 2015, retrieved from: https://www.unece.org/fileadmin/DAM/trans/doc/2015/dgac10c3/ST-SG-AC.10-C.3-2015-21e-ST-SG-AC.10-C.4-2015-2e.pdf).
Current ILO guidance in the ILO Encyclopedia of Occupational Safety
and Health urges reliance on international agreements, and the UNTDG
guidance in particular for chemicals and the Basel Convention for waste
(see ILO Encyclopedia, freely available at https://www.ilo.org/safework/info/publications/WCMS_113329/lang-en/index.htm). As discussed
previously, the UNTDG guidance does not refer to either pH in general
or to a particular pH range.
Finally, the Basel Convention also has a physical and chemical
hazard classification system for waste that addresses corrosivity and
which is described in several Annexes to the Convention. The Basel
Convention does not rely on the 11.5 pH value in defining corrosive
waste as a general matter in Annex III, but does rely on it as a
rebuttable presumptive value for corrosive solutions in the Annex IX
(non-hazardous) waste listings. Under the Basel Convention, listed
hazardous waste can be delisted by showing that it exhibits no Annex
III characteristics.
Unlike many of the other regulatory frameworks that the petitioners
cite, the Basel Convention classification system, like RCRA, applies
specifically to hazardous waste management. However, the Basel
Convention and its hazardous waste classification system take into
account the limited capabilities of the developing countries to manage
hazardous waste and other waste (see Preamble to the Basel Convention).
The Basel Convention takes a precautionary approach, broadly
characterizing materials as hazardous out of an abundance of caution.
The U.S., on the other hand, has substantial capacity for proper
management of both hazardous and non-hazardous wastes, and therefore
current RCRA regulations do not incorporate the level of precaution
that the Basel Convention does in classifying waste as hazardous under
RCRA.\15\
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\15\ A significant purpose of the Basel Convention is to control
the export of hazardous waste from developed to developing
countries, because many developing countries do not have the
capacity to safely manage either hazardous or non-hazardous waste.
Most Basel hazardous waste listings do not include concentration
values for hazardous constituents below which the waste would be
considered non-hazardous, because many developing nations do not
have adequate capacity to safely manage even non-hazardous waste.
Basel listings are written so wastes posing any degree of hazard may
be subject to the Basel notice and consent provisions, thereby
enabling developing countries to refuse waste shipments they are
unable to safely manage.
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Additionally, the EPA considers degrees of risk in classifying
waste as hazardous, taking into account the comprehensive nature of the
U.S. waste management system. The United States has extensive
regulatory and physical capacity for environmentally sound waste
management, including capacity for management of both hazardous and
non-hazardous waste. Many forms of mismanagement that may occur in
developing nations are already illegal in the U.S., and so any such
mismanagement would not be considered a basis for revising or
developing new hazardous waste regulations (that is, types of waste
mismanagement that are already illegal under RCRA would be addressed as
enforcement/compliance issues, rather than as the basis for new
regulations). Further, the structure of the Basel hazardous waste
classification system is different from that of RCRA. While the
presumption of corrosiveness at pH 11.5 under Basel is rebuttable using
the Annex III criteria, the RCRA corrosivity definition is a hard
value, and there is no opportunity in the RCRA regulations to show that
a waste is non-corrosive despite its exceedance of the regulatory
criteria. Seen in this light, the degree of precaution incorporated in
Basel's use of pH 11.5 may not be warranted in U.S. waste regulations.
In the U.S., the DOT hazardous materials regulatory definition of
``corrosive material'' is a narrative that does not reference the pH of
materials. Rather, corrosive material is defined as ``. . . a liquid or
solid that causes full thickness destruction of human skin at the site
of contact within a specified period of time'' (see 49 CFR 173.136(a)).
DOT referenced the 1992 OECD testing guideline #404, among other
international guidances, when it updated its regulations to harmonize
with the UNTGD Guidance (59 FR 67390, 67400 and 67508, December 29,
1994). The OECD Testing Guideline #404 is based on results of live
animal testing or other direct experience with the chemical, although
testing on live animals is being phased out where possible.
OSHA identifies the hazards of chemicals to which workers may be
exposed, including corrosivity hazards. OSHA recently harmonized its
Hazard Communication Standard (HCS) with the GHS classification
criteria, including a modified version of the GHS criteria for
corrosivity (GHS Revision 3, 2009; see: 77 FR 17574, 17710, and 17796
March 26, 2012). The CPSC implements the Federal Hazardous Substances
Act (FHSA), and includes corrosives as hazardous substances in its
implementing regulations. Under FHSA regulations, ``Corrosive means any
substance which in contact with living tissue will cause destruction of
tissue by chemical action . . .'' 16 CFR 1500.3(b)(7). This definition
is further elaborated at 16 CFR 1500.3(c)(3), where a corrosive
substance is one that, ``. . . causes visible destruction or
irreversible alterations in the tissue at the site of contact.''
The petitioners also argue that EPA pesticides regulations rely on
a pH value of 11.5 to define corrosivity. However, that
characterization misunderstands the regulatory framework for product
pesticides. EPA regulation of pesticides under the FIFRA require
evaluation of the potential for chemicals to cause primary eye or
dermal irritation as part of the required toxicology evaluation (see 40
CFR 158.500). Test guidelines (EPA 1998a, b) describe live animal
testing as the basis for dermal or ocular irritation, although pre-test
considerations note that substances known (based on existing data) to
be corrosive or severely irritating, or that have been assessed in
validated in vitro tests, or have a pH of 11.5 or greater (with
buffering capacity accounted for) may be considered irritants and need
not be tested in live animals, if the applicant so chooses. As noted in
the preamble to the relevant rule, the Agency considered the importance
of minimizing animal testing, and stated that it would consider data
from validated in vitro tests as a way to reduce animal testing
requirements (see 72 FR 60934, October 26, 2007). Because pH 11.5 may
be used as an optional presumption for toxicity categorization, the
regulatory framework contemplates that chemicals having pH 11.5 may not
be corrosive, and it allows the applicant to submit live animal testing
data demonstrating that a particular pesticide is not a dermal or
ocular irritant.
While the pH of a material can play some role in corrosivity
determinations in these other regulatory frameworks, pH 11.5 is not the
primary means of identifying corrosive materials except in the Basel
Convention. In FIFRA, it may be used as part of the basis for
precautionary labeling of pesticides, if the registrant elects to rely
on it. It is a third-tier criteria in the GHS system, but is not
referenced by the regulations of DOT or by the UNTDG guidance. Further,
the experts of GHS and UNTDG are continuing work to harmonize
[[Page 21302]]
model regulations for corrosive materials, illustrating the fact that
corrosivity assessment methods and criteria are not well settled
matters.
In fact, historically, in vivo animal test data has been the
primary basis for classification, and because of increasing animal
welfare concerns with live animal testing, development of new methods
for evaluating the corrosivity of materials has been an active research
area, involving the development of new in vitro tests and structure-
activity relationship models. Alternative test development has been
driven largely by the desire to reduce the use of live animals, in
particular, for making corrosivity determinations for chemicals. These
alternatives to animal testing have been validated in some cases
(Barratt et al., 1998; Kolle et al., 2012), and incorporated into the
corrosivity evaluations of the OECD testing framework (see OECD tests
430, 431, 435, 437, and 438, in particular). A number of studies
attempting to correlate chemical structure with corrosive potential, or
QSAR evaluations have also been published in recent years. These have
focused primarily on the corrosivity potential of organic chemicals,
and attempt to address both corrosivity and irritation potential.
(Hulezebos et al., 2005)
In addition, the pH 11.5 value in these other frameworks is used
only as an optional approach or a rebuttable presumption of
corrosiveness. That is, chemical manufacturers or waste generators have
in all cases the opportunity to conduct additional testing if they
believe their product or waste is not corrosive despite exhibiting pH
11.5 or higher.\16\ However, as used in the RCRA corrosivity
regulation, the pH of an aqueous waste determines whether that waste is
a corrosive hazardous waste as a legal matter, and there is no
opportunity to rebut this classification for an aqueous waste that
exhibits pH 12.5 or higher. Thus, lowering the pH in RCRA has far-
reaching implications that are not present in other regulatory systems.
---------------------------------------------------------------------------
\16\ A number of researchers have identified solutions
exhibiting pH values higher than pH 11.5 that are nonetheless not
classified as corrosive. Murphy, et al., (1982) found that none of
the test rabbits exposed to 0.1% and 0.3% NaOH solution (pH 12.3 and
pH 12.8 respectively) developed corneal opacity (i.e., 0/6) even
when the eyes were not washed after exposure. Young et al. (1988)
identified a 1% KOH solution, with pH 13.3 as an irritant but not
corrosive. The following solutions were also classified either as
irritants or as not dangerous: 1% NaOH, with pH 13.4; 10%
NH3, with pH 12.2; Na2CO3, with pH
11.6; and Na3PO4, with pH 12.3. Similarly,
Oliver, et al., (1988) and Barratt et al. (1998) identified several
materials exhibiting pH values higher than pH 11.5 that were
nonetheless not classified as corrosive.
---------------------------------------------------------------------------
Moreover, many of the standards discussed above are concerned with
product chemicals and formulations, not waste. As products are
manufactured to a certain specification, they can be evaluated for
safety once, and typically that evaluation can be relied on going
forward (unless the formulation changes or there is some indication the
initial evaluation was flawed). However, waste is not manufactured to a
specification, but rather may vary from batch-to-batch, sometimes
widely. Therefore, the more careful, thorough evaluation, as described
in OECD Method 404, for example, is not practical for use on each
separate batch of waste generated. The simpler approach of relying on
pH value was therefore used by the EPA in developing the corrosivity
regulation, as pH is a useful indicator of hazard potential, and
testing for pH is reasonable to perform for many wastes.
Finally, the petitioners argue that the RCRA corrosivity
characteristic regulation should be changed because other regulatory
frameworks rely on it (see petition at 12 (discussing DOT and the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) regulations' cross references to RCRA)). However, to the
extent that petitioners are concerned about shortcomings in DOT or
CERCLA regulations, the appropriate avenue for changes in those
frameworks is to seek changes directly to those frameworks. The RCRA
regulatory framework is focused on management of hazardous waste, and
should not be amended solely on the basis of perceived shortcomings in
other regulatory frameworks.
In sum, while other regulatory frameworks may use pH 11.5 as part
of their corrosivity determinations, the use of pH 11.5 in these
frameworks is fundamentally different from the use of pH in the RCRA
corrosivity characteristic regulation, and such use, therefore, should
not set a precedent for RCRA regulation.
2. Request To Include Nonaqueous Corrosive Materials Within the Scope
of RCRA's Corrosivity Characteristic
a. Exposure to World Trade Center 9/11 Dust
In seeking to expand the scope of the corrosivity characteristic to
include nonaqueous wastes in addition to revising the regulatory value
to pH 11.5, the petition argues that injury to 9/11 first responders,
other workers, and potentially members of the public, was caused by
corrosive properties of airborne cement dust present in the air as a
result of the buildings' collapse. Further, the petition argues that
regulation of these airborne dusts as RCRA hazardous wastes would have
prompted wide-spread respirator use and prevented first responder lung
injury, and can prevent such injury to demolition workers and the
general public present at future building demolitions.
However, after a thorough review of the information currently
before the Agency,\17\ the Agency has tentatively concluded that
petitioners' arguments to include nonaqueous wastes within the scope of
the corrosivity characteristic are not supported by the events of the
World Trade Center (WTC) for at least three reasons: (1) It is not
possible to establish a causal connection between the potential
corrosive properties of the dust and the resultant injuries to those
exposed; (2) the injuries documented at the WTC in connection with
potentially harmful dust are not consistent with injuries caused by
corrosive material; and (3) nothing submitted by petitioners
demonstrates that injury to human health or the environment was related
to improper treatment, storage, transport, or disposal of solid waste
(i.e. the petition does not demonstrate how RCRA would or could address
the potential exposures alleged to be hazardous). The Agency is seeking
comment on these tentative conclusions.
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\17\ While the Agency has reviewed numerous studies, and we
believe we have considered key studies, the body of literature
published on the events of 9/11/01 is voluminous. As part of
soliciting public comments the Agency is interested in any
additional key studies that should be considered as relevant to the
issues considered in this document.
---------------------------------------------------------------------------
While there is a substantial body of research and broad consensus
that exposure to the 9/11 atmosphere for the first hours after the
collapse of the towers, and for some time thereafter, caused adverse
health effects in first responders and others, this atmosphere was a
complex combination of dust, fibers, smoke, and gases. As reported by
the New York Fire Department Bureau of Health Services (FDNY 2007; p.
24), ``[w]hen the towers collapsed, an enormous dust cloud with a high
concentration of particulate matter consumed lower Manhattan.''
Analysis of the settled dust from samples collected in the days
following September 11 shows that it consisted of a number of
materials, including concrete dust, toxic metals, silica, asbestos,
wood fiber, fiberglass, and smoke particulates from the fires (EPA
[[Page 21303]]
2002, Chen and Thurston, 2002; Landrigan et al., 2004; Lorber et al.,
2007; Lioy et al., 2002; Lioy et al., 2006).
Further, while initial exposures are known to be very high for
those near the towers when they collapsed, the distribution of
exposures is not well documented nor quantitated (Lioy et al., 2006;
Lorber et al., 2007). Because of the complex nature of the ambient
atmosphere on 9/11, and lack of exposure data (although exposures were
clearly very significant for many people), it is not possible to
establish a causal connection between the potential corrosive
properties of the dust and the resultant injuries to those exposed, to
the exclusion of other co-occurring exposures. These co-occurring
exposures include glass fiber, silica, cellulose, metals, wood fiber
and fiberglass, a number of minerals (calcite, gypsum, quartz) and a
wide range of organic polyaromatic hydrocarbons (PAHs) and dioxin (see
docket for OSHA Sampling Results Summary; Lippy, 2001 (NIEHS); EPA,
2002; Lioy, 2002; Chen & Thurston, 2002).
Other factors also argue against the use of the 9/11 disaster as an
event that would support changing the RCRA corrosivity regulation.
Most, but not all, outdoor dust samples tested for pH were below pH 11,
and so would not be classified as corrosive hazardous waste under the
regulatory changes proposed by the petition. These include data in
studies by EPA, 2002; USGS, 2001; ATSDR, 2002; McGee et al., 2003; and
Lorber et al., 2007. Some indoor dust samples had pH values as high as
pH 11.8 (USGS, 2001). While the petition discounts these data as not
representing actual exposures to the 9/11 airborne dust, and expresses
concern that the samples were evaluated using several different
protocols,\18\ they are nonetheless the only pH data known to the
Agency.
---------------------------------------------------------------------------
\18\ Water must be added to a dust in order to test its pH, as
in EPA Method 9045. Dust pH was evaluated by different investigators
using methods they believed appropriate for the particular studies
being conducted. Investigators used different liquid/solid ratios,
and for one data set, pH was tested in the course of running a
deionized water leaching test (initial pH of the water approximately
pH 5.5).
---------------------------------------------------------------------------
The pH values found for the WTC dust are generally consistent with
pH testing of waste concrete fine aggregates being recycled, for which
pH values are often less than pH 11.5 (Poon, 2006). This is supported
by information from Material Safety Data Sheets (MSDS) for crushed
concrete aggregate, which reported pH 7 for this material (LaFarge
MSDS, revised 3/1/2011), although Gotoh et al. (2002) found pH values
ranging from 11.6-12.6 for five samples of concrete dust generated by
building demolition resulting from an earthquake.
In addition, numerous studies of exposed workers and laboratory
test animals fail to identify the gross damage to human tissue used as
a benchmark in defining corrosive materials as an effect resulting from
exposure to WTC dust. The 1980 RCRA background document supporting the
corrosivity regulation notes that ``[s]trong base or alkalis . . .
exert chemical action by dissolving skin proteins, combining with
cutaneous fats, and severely damaging keratin.'' Typical injury
endpoints used in guidance for defining a material as corrosive
describe ``. . .visible necrosis through the epidermis and into the
dermis . . .''. ``Corrosive reactions are typified by ulcers, bleeding,
bloody scabs . . . .'' (GHS 3.2.1).
In reviewing the published literature describing injury to 9/11
exposed workers and residents, none describe gross respiratory tissue
destruction or other injuries of the severity identified in definitions
of corrosivity. Rather, adverse effects in various studies describe
respiratory irritation and other adverse effects. Chen & Thurston
(2002) identified ``World Trade Center Cough'', and noted that exposure
to the larger particles cause temporary nose, throat, and upper airway
symptoms. In a review of exposure and health effects data, Lioy et al.
(2006) identified the major health consequences of WTC exposure as
``aerodigestive and mental health related illnesses.'' The WTC
aerodigestive syndrome is identified as consisting of ``. . . WTC
cough, irritant asthma or reactive airways dysfunction syndrome and
gastroesophageal reflux disorder.'' In September of 2011, The Lancet
published a series of articles reviewing and updating the research on
adverse health effects suffered by those exposed to the WTC atmosphere.
Perlman et al. (2011) identified upper and lower respiratory effects,
including asthma, wheezing, tightness in the chest, and reactive airway
dysfunction syndrome, as well as gastroesophageal reflux symptoms.
Wesnivesky et al. (2011) identified updated occurrence rates of the
adverse effects described by Perelman through a longitudinal cohort
study, and it found a 42% incidence of spirometric abnormalities nine
years after the exposures. Jordan et al. (2011) studied mortality among
those registered in the World Trade Center Health Registry. No
significantly increased mortality rates (SMR) for respiratory or heart
disease were found, although increased mortality from all causes was
found in more highly exposed individuals compared with the low exposure
group. Finally, Zeig-Owens et al. (2011) studied cancer incidence in
New York firefighters, including those exposed to the WTC dust, and
found a modest increase in the cancer rates for the exposed group.
However, the authors remained cautious in their conclusions, as no
specific organs were preferentially affected, and the nine years since
exposure does not represent the full latency period for development of
many cancers. While the WTC-exposed populations in these studies
experienced adverse health effects related to exposures, they are not
effects of the nature and severity that the corrosivity regulation was
intended to prevent.\19\
---------------------------------------------------------------------------
\19\ This may raise the question of whether the Agency should
consider regulating waste dusts that are respiratory irritants as
hazardous waste under RCRA. However, that question is outside the
scope of the petition. As discussed herein, the petition fails to
show how RCRA regulation could address any of the alleged exposures,
and therefore does not support such regulation. Evaluation of
whether the Agency should regulate respiratory irritants as
hazardous waste would require additional information and analysis,
including evaluation of whether ``respiratory irritants'' meet the
statutory and regulatory definition of hazardous waste; and, if so,
which tests or criteria would be appropriate to identify such
irritants.
---------------------------------------------------------------------------
The petition identifies several particular studies that the
petitioners believe demonstrate corrosive effects of the WTC dust, and
it cites to several passages, apparently taken from these studies as
supporting the petition (see page 30; the referenced publications are
identified in footnotes (FN) to the petition).
The first passage identifies papers by Weiden et al. (2010; FN 88)
and Aldrich, et al. (2010; FN 89) as the source of information. The
petition extracts a quotation from the Weiden (2010) paper's discussion
section that noted, ``The WTC collapse produced a massive exposure to
respirable particulates, with the larger size dust fractions having a
pH ranging from 9 to11, leading to an alkaline ``burn'' of mucosal
surfaces.'' However, this publication presented research on pulmonary
capacity, and it states its primary conclusion in the paper's abstract
as follows: ``Airways obstruction was the predominant physiological
finding underlying the reduction in lung function post September 11,
2001, in FDNY WTC rescue workers presenting for pulmonary evaluation.''
The idea of an alkaline ``burn'' is at best inferred; it is not an
effect directly observed or evaluated by the researchers, nor is it one
of the findings of the study. The Aldrich et al. (2010; FN89) study
similarly conducted spirometry (lung function) studies of exposed
firefighters
[[Page 21304]]
and others. This abstract of this study reported that, ``Exposure to
World Trade Center dust led to large declines in FEV1 (1-second forced
expiratory volume) for FDNY rescue workers during the first year.
Overall, these declines were persistent . . .''. The paper found there
was no association between time of first responder/worker arrival at
the WTC site and chronic effects. The paper discussion did note that
the intensity of initial exposure was linked to acute lung
inflammation, although there was no reference to ``chemical burns'' or
other possible descriptors of chemical corrosive effects on workers'
tissues.
The petition also cites an October 2009 poster presentation/
abstract (Kim et al., 2009; FN90) from an American College of Chest
Physicians meeting providing the results of a study of asthma
prevalence in WTC responders. The petition is generally accurate in
reflecting the researchers' conclusion that asthma in WTC responders
doubled over the study period 2002-2005, and in noting exposures to
dust and toxic pollutants following the 9/11 attacks. There was no
report in the paper of corrosive injuries to the workers.
Footnote 91 references a New York Times newspaper article of April
7, 2010, reporting on the pending publication of the paper by Aldrich
et al. (2010; FN89) in the New England Journal of Medicine. The
petition quotes from the New York Times article, noting that, ``The
cloud contained pulverized glass and cement, insulation fibers,
asbestos and numerous toxic chemicals. It caused acute inflammation of
the airways and the lungs. Dr. Prezant said.'' The article also noted,
``This was not a regular fire,'' Dr. Prezant said. ``There were
thousands of gallons of burning jet fuel and an immense, dense
particulate matter cloud that enveloped these workers for days.'' This
article again illustrates the complex nature of the exposures to first
responders and others at the WTC site, and does not include corrosive
injury when noting the acute effects of this exposure.
The petition next quotes from a NY Fire Department, Bureau of
Health Services report (FDNY, 2007; FN 92) which reports on upper
respiratory symptoms in firefighters (cough, nasal congestion, sore
throat) from the day of the attacks as well as at intervals up to 2-4
years in the future. The report notes that ``Particulate matter
analysis has shown a highly alkaline pH of WTC dust (like lye), which
is extremely irritating to the upper and lower airways.'' Earlier
discussion in the report (p.24) notes that firefighters were exposed to
``. . . an enormous dust cloud with a high concentration of particulate
matter consumed lower Manhattan.'' The WTC dust not only had very high
particulate concentrations, but was also a complex mixture of
materials.
Finally, the petition cites a portion of the discussion in a paper
published by Reibman, et al., (2009; FN 94), which notes that,
``[m]easurements of settled dust documented that these particles were
highly alkaline (pH 11), and this property alone has been shown to be
associated with respiratory effects. Occupational exposure to inhaled
alkaline material induces chronic cough, phlegm, and dyspnea, as well
as upper respiratory tract symptoms.'' This paper presented the results
of spirometry (lung function) testing, and concluded that the exposed
population had, ``. . . persistent respiratory symptoms with lung
function abnormalities 5 or more years after the WTC destruction.'' As
in describing the results of other research on the WTC exposed
populations, these studies identify a number of adverse effects
attributable to WTC exposures from the day of the towers' collapse, as
well as subsequent exposures occurring during site rescue and
demolition and clean-up activities. While the adverse effects
identified represent serious injuries to many workers, these injuries
do not appear to include the type of gross tissue destruction of skin
or the respiratory tract that is the underlying basis for defining
materials as corrosive (i.e., destroying tissue by dissolving or
coagulating skin proteins). Rather, these effects are associated with
inflammatory and irritant properties of inhaled materials.
Similarly, laboratory toxicity studies in which mice were exposed
to collected 9/11 dust samples (PM2.5), adverse effects were
limited to mild to moderate degrees of airway inflammation. The test
animals did experience increased responsiveness to methylcholine
aerosol challenge (EPA, 2002), suggesting an irritant response to the
WTC particulate matter. While these studies again suggest an irritant
response to the 9/11 dust samples, they do not demonstrate corrosive
injury.
If one were to apply the criteria for classifying dusts as
corrosive, such as GHS (which does provide guidance for identifying
nonaqueous corrosives) to the WTC data, WTC dust would not have been
assessed as corrosive. GHS defines skin corrosion as ``. . . visible
necrosis, through the dermis and into the epidermis . . . Corrosive
reactions are typified by ulcers, bleeding, bloody scabs . . .'' (GHS
3.2.1.). None of these reactions to the WTC dust have been identified
in the published literature cited by the petition, nor in studies
identified in the Agency's review. The background information for the
current RCRA corrosivity characteristic regulation references
dissolution of skin proteins, combination of the corrosive substance
with cutaneous fats, and severe damage to keratin as the adverse
effects the regulation is intended to prevent. These kinds of injuries
have not been reported in the published scientific literature
presenting studies of WTC adverse effects.
The petition also argues that classification of the 9/11 dust as
RCRA hazardous may have impacted workers' respirator use at the 9/11
site. However, this argument does not appear to have support. OSHA's
regulations govern worker safety (e.g., respirator use) when workers
are handling hazardous substances in emergency response (see 29 CFR
1910.120(a)). While the petitioner is correct that CERCLA regulations
incorporate RCRA hazardous wastes as part of the universe of
``hazardous substances,'' (see petition at 8 (citing 40 CFR 302.4(b)),
the universe of substances that give rise to worker safety regulations
is much broader than RCRA hazardous wastes (see 29 CFR 1910.120(a)).
Petitioners provide no support for the contention that broadening the
universe of waste classified as RCRA-hazardous for corrosivity would
have had any impact on the level of worker safety regulation imposed at
the WTC site.\20\
---------------------------------------------------------------------------
\20\ Petitioners also argue that regulating nonaqueous wastes
with a pH between 11.5 and 12.5 would have made the first responders
``more motivated'' to wear respirators. Petition at 23. However,
there is no support for this argument, and EPA does not find this
type of unsupported suggestion sufficient to warrant regulation of a
new universe of waste as hazardous.
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Finally, nothing submitted by petitioners indicates that injury to
human health or the environment at the WTC was related to improper
treatment, storage, transport, or disposal of solid waste.\21\
Similarly, petitioners fail to explain how the exposures they are
concerned about at the WTC site were related to waste management
activities. The complexity and duration of exposures and the lack of
documentation makes it infeasible to distinguish the ambient air
exposures directly resulting from the initial collapse of the towers
(and ongoing fires) from exposures potentially related to waste
management. Without any
[[Page 21305]]
support for the proposition that petitioners' concerns are RCRA
concerns, there is similarly no indication that amending the RCRA
regulations would address similar concerns during future emergency
response events.
---------------------------------------------------------------------------
\21\ See 42 U.S.C. 6903(5); the definition of hazardous waste
includes, in part, solid wastes that may ``pose a substantial
present or potential hazard to human health or the environment when
improperly treated, stored, transported, or disposed of, or
otherwise managed.''
---------------------------------------------------------------------------
In sum, it is not possible to establish a causal connection between
the potential corrosive properties of the dust and the resultant
injuries to those exposed. The injuries documented at the WTC in
connection with potentially harmful dust are not consistent with
injuries caused by corrosive material. And finally, nothing submitted
by petitioners demonstrates that injury to human health or the
environment was related to improper treatment, storage, transport, or
disposal of solid waste (i.e. the petition does not demonstrate how
RCRA would or could address the potential exposures alleged to be
hazardous).
b. Exposure to Concrete Dust
Petitioners also argue that corrosive injury could result from the
corrosive properties of inhaled concrete dust present in the air as a
result of building demolition by implosion. While the petition
illustrates the potential for exposure to concrete dust from several
building demolitions, no documented evidence of corrosive (or other)
injury from building demolition is provided. The petition, therefore,
fails to support the argument that concrete dust should be regulated as
corrosive hazardous waste.
Concrete is among the most common construction materials used in
the US. It is a mixture of Portland cement (10-15%) and aggregate (60-
75%), with water added (15-20%) to allow hydration of the cement, which
results in its solidification (Portland Cement Association, 2015).
Concrete may include some entrained air, and in some cases, a portion
of the Portland cement may be replaced with combustion fly ash,
particularly coal fly ash. Cement is made when lime (CaO), silica
(SiO2), alumina (Al2O3), iron oxide
(Fe2O3), and sulfate (SO3) are burned
together in a cement kiln at approximately 2600 degrees Fahrenheit
([deg]F). The resulting material, called ``clinker'', which contains
more complex mineral forms of the ingredients, is ground to a fine
powder, and gypsum is added (CaSO4-2 H2O). This
powder is cement; when added to aggregate and hydrated, it becomes
concrete.
The other key component of concrete is the aggregate. Both fine and
coarse aggregate are used, with their proportions varying depending on
the particular use of the concrete. A variety of materials may be used
as aggregate, with recently increasing emphasis on use of recycled
materials as aggregate (e.g., glass, ceramic scrap, crushed concrete;
Marie and Quaisrawi, 2012; Castro and Brito, 2013). However,
traditional aggregate is sand and gravel from different types of rock.
These include silica sand, quartz, granite, limestone and many others.
There exists a whole field of study dedicated to understanding the
properties and best uses of different kinds of aggregate materials in
making concrete (PCA, 2003). Many of the materials used as concrete
aggregate include silica minerals, and crystalline silica dust exposure
is a significant occupational exposure concern, as it can cause
respiratory injury known as silicosis (see 78 FR 56274, September 12,
2013). In silicosis, inhaled crystalline silica dust can cause fluid
accumulation and scarring of the lungs, which can reduce respiratory
capacity (American Lung Association, ``Learn about Silicosis.''
retrieved from https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/silicosis/learn-about-silicosis.html). Various MSDS for
ready mix concrete (i.e., cement pre-mixed with aggregate; just add
water) identify its crystalline silica content as, in one case, 20-85%,
in another, as 0-90% (MSDS-Ready Mixed Concrete, April 14, 2011; MSDS-
Lafarge Crushed Concrete, March 1, 2011).
Many of the compounds and oxides present in concrete are already
regulated by OSHA when they occur as airborne dust. These include
calcium silicates, calcium hydroxide, calcium oxide, and silicates.
OSHA sets worker exposure standards for these chemicals, known as
``permissible exposure levels'' (PELs; see 29 CFR 1910.1000, tables Z-1
and Z-3, in particular). The PEL for airborne calcium oxide dust is 5
mg/m\3\; those for calcium hydroxide and calcium silicate are 15 mg/
m\3\ for total dust, and 5 mg/m\3\ for respirable dust; all measured as
8 hour time weighted average (TWA) values.
There appear to be few studies published in the peer-reviewed
scientific literature that have examined the adverse health effects of
exposure specifically to concrete dust. OSHA includes concrete dust
among the materials that would be covered under their proposed
regulation to revise the PEL for respirable crystalline silica
(September 12, 2013; 78 FR 56274). OSHA's ``Occupational Exposure to
Respirable Crystalline Silica--Review of Health Effects Literature and
Preliminary Quantitative Risk Assessment'' (OSHA, 2013), developed in
support of its proposed regulation, identifies concrete production as
among the industries whose workers are likely to be exposed to
crystalline silica, and notes that several of the health effects
studies OSHA relied on in its assessment consider exposure to brick or
concrete dust as risk factors for cancers caused by silica. The one
study that specifically considered the adverse health effects of
concrete dust exposure to 144 concrete workers identified ``. . . mild
chronic obstructive pulmonary disease at respirable concrete dust
levels below 1 mg/m\3\, with a respirable crystalline silica content of
10% (TWA 8 hr.).'' (Meijer et al., 2001). Neither this report, nor the
OSHA silica rule risk assessment document noted any corrosive effects
in workers exposed to respirable concrete dust. Other OSHA literature
on concrete does identify potential effects from exposure to cement
dust or wet concrete, ranging from moderate irritation to chemical
burns (OSHA Pocket Guide on Concrete Manufacturing; available online at
https://www.osha.gov/Publications/3221_Concrete.pdf). However, neither
the petition nor information gathered through the Agency's independent
review of the literature provides sufficient specificity for the Agency
to analyze whether this ``Pocket Guide'' supports the regulatory
changes requested. For example, it is not clear whether any of the
potential exposures cited in the document involved actual waste
management scenarios. Given the wide range of potential effects cited,
it is also not clear how the pH of the material would relate to that
range of potential effects. Finally, as discussed above, many of the
compounds and oxides present in concrete are already regulated by OSHA,
and, where OSHA evaluated the risks of respirable concrete dust as part
of its silica rule, its studies did not cite potential corrosive
effects of concrete dust as part of the worker health concern the
regulation was focused on controlling.
OSHA also distinguishes inert, or nuisance dust from fibrogenic
dust, such as crystalline silica or asbestos. Nuisance dust is dust
containing less than 1% quartz, a form of crystalline silica; the PEL
values for nuisance dust are also 15 mg/m\3\ total dust and 5 mg/m\3\
for the respirable fraction, the same PEL values as for calcium
hydroxide and calcium silicate dusts. (OSHA, ``Chapter 1: Dust and its
Control,'' retrieved from https://www.osha.gov/dsg/topics/silicacrystalline/dust/chapter_1.html).\22\
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\22\ Some of the exposures that petitioners are concerned about
may also be addressed by the National Ambient Air Quality Standards
(``NAAQS'') for particulate matter (40 CFR pt. 50) and the National
Emission Standards for Hazardous Air Pollutants (``NESHAPs'') for
asbestos (40 CFR pt. 61, subpt. M).
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[[Page 21306]]
In sum, while the petition alleges harmful exposure to concrete
dust from several building demolitions, no documented evidence of
corrosive (or other) injury from building demolition is provided in the
petition. Similarly, the literature on this topic is limited, and what
limited literature does exist does not demonstrate that the
petitioners' requested regulatory changes are warranted.
c. Exposure to Cement Kiln Dust
The petition also argues that corrosive injury could result from
the corrosive properties of Cement Kiln Dust (CKD). However, the
petition again fails to provide any evidence demonstrating that CKD
would be appropriately characterized as corrosive under RCRA.
CKD is an air pollution control residue collected during Portland
cement manufacture. CKD was exempted from regulation as hazardous waste
under RCRA pending completion of a report to Congress providing an
evaluation of CKD properties, potential hazards, current management,
and other information, by the Bevill Amendment to RCRA (see 42 U.S.C.
6921(b)(3)(A)(i) through (iii)). Following completion of the Report,
the EPA was required to determine whether regulation of CKD as
hazardous waste is warranted. EPA published its Report to congress on
CKD in 1993 (see docket for Report to Congress on CKD, 1993), and
published a RCRA regulatory determination in 1995 (60 FR 7366, February
7, 1995). Most CKD is managed on-site in non-engineered landfills,
piles, and ponds, which lack liners, leachate collection and run-on/
runoff controls. Wind-blown CKD was cited as a concern in a number of
the damage cases resulting from CKD management, but the Agency did not
identify any cases of corrosive injury either to workers or the general
public. The risk assessment portion of the Report examined possible
direct exposures to CKD via the air pathway and found:
``Quantitative modeling of air pathway risks to people living
near case-study facilities indicated that wind erosion and
mechanical disturbances of on-site CKD piles do not result in
significant risks at nearby residences via direct inhalation (e.g.,
central tendency and high end risks estimates were all less than 1 x
10-11 increased individual cancer risk at all five
facilities modeled). However, fugitive dust from on-site CKD piles
was estimated to be one of two contributors in some cases to higher
risk estimates for indirect exposure pathways (which were primarily
a result of direct surface run-off from the CKD pile reaching an
agricultural field).'' See docket for Report to Congress on CKD,
page 6-51.
Subsequent screening level modelling found that windblown fugitive
CKD could cause violations of the Clean Air Act fine particulate matter
ambient air quality standard (PM 10) at plant boundaries and
potentially at nearby residences. The Agency's regulatory determination
for CKD concluded that existing fugitive dust controls were ineffective
in preventing fugitive releases to the air, and determined that
additional controls were warranted due to risks from fugitive air
emissions and runoff to surface waters in particular, and also due to
the potential for metals to leach into groundwater. However, no
corrosive injuries were identified.
EPA published a proposed rule in 1999 (64 FR 45632, August 20,
1999) to address these concerns. The proposal focused in particular on
improving runoff controls from CKD piles, and controlling fugitive dust
releases, as well as performance-based controls on release to
groundwater. Action on this proposed rule has not been finalized.\23\
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\23\ While action on RCRA regulation has not yet been finalized,
EPA has established standards for emissions of hazardous air
pollutants from the Portland cement manufacturing industry under
section 112 of the Clean Air Act. See, e.g., 40 CFR pt. 63, subpt.
LLL.
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A number of new studies and data reviews have been published since
the 1999 proposal. These include a 2006 review of the effects of
Portland cement dust exposure by the United Kingdom Health and Safety
Executive (2005) and studies published in the scientific literature by
van Berlo et al., (2009); Isikli et al., (2006); Ogunbileje et al.,
(2013); Ogunbileje et al., (2014); Orman et al., (2005); and Fatima et
al., (2001). While several of these studies note that cement dust may
be an irritant, or cause contact dermatitis, none identified corrosive
injury resulting from exposures to CKD or Portland cement dust.
In sum, while the petition alleges harmful exposure from CKD, the
current record before the Agency fails to support that CKD should be
regulated as corrosive under RCRA.
B. Wastes That May Be Newly Regulated Under the Requested Revisions
In the process of reviewing and evaluating the petition, the Agency
has focused primarily on understanding and responding to the issues
raised by the petition. While the petition focuses on exposure and
health effects issues, it does not address the issue of the impacts of
the petition's proposed regulatory changes. At this point in its
review, the Agency has not developed a systematic assessment of the
types and volumes of waste that might be newly regulated as hazardous
if the Agency were to make the requested changes to the corrosivity
characteristic regulations. However, interested industry stakeholders
have reviewed the petition and sent the Agency their estimates of the
types and volumes of wastes generated by their industries that might
become RCRA hazardous under the petitioners' proposed regulatory
revisions. The industry stakeholders believe these wastes are currently
managed or reused safely, and that regulating them as hazardous waste
would not produce a corresponding benefit to worker, public or
environmental safety. The Agency has not evaluated their estimates.
While the industry estimates are informal, they may nonetheless provide
at least a qualitative, and, to some degree, a quantitative estimate of
waste that could become newly regulated were the Agency to make the
requested regulatory changes. See Letters of September 30, 2015 and
November 30 2015, from Wittenborn and Green. Also see letter of
September 4, 2015 from Waste Management, and August 28, 2015 letter
from the National Waste and Recycling Association, in the rulemaking
docket for this document.
C. Determining What Waste Is ``Aqueous''
As a part of the argument regarding regulation of solid corrosives,
the petition asserts that the current corrosivity regulation is
ambiguous, particularly with regard to the definition of the term
``aqueous'' as used in 40 CFR 261.22(a)(1) and that this causes
confusion in implementing the regulation (see page 36 of the petition).
The petition also asserts that inclusion of nonaqueous wastes within
the scope of the characteristic is consistent with the approach taken
by other federal agencies, and would clarify this issue. Method 9040
(in ``Test Methods for Evaluating Solid Waste, Physical/Chemical
Methods,'' also known as SW-846), which is incorporated into the
corrosivity characteristic regulation to test for pH, is used to
evaluate ``aqueous wastes and those multiphase wastes where the aqueous
phase constitutes at least 20% of the total volume of the waste''. A
number of EPA policy letters on determining what wastes are aqueous,
referred to in the paragraph below, do identify more than one approach
to distinguishing aqueous from nonaqueous wastes. However,
[[Page 21307]]
while petitioners are correct in noting that the inclusion of
nonaqueous wastes within the scope of the corrosivity characteristic
would address this issue, the Agency currently lacks data demonstrating
that regulation of nonaqueous wastes as corrosive is warranted under
RCRA. Therefore any clarification of the term ``aqueous'' should be
appropriately tailored and narrower than the change the petition
recommends.
The Agency did address this issue when developing the corrosivity
characteristic definition in 1980. The background document discusses
how to address the potential for analytical interference in testing
wastes that may be suspensions or gel type material. At least one
commenter urged the Agency to define the term ``aqueous''; however, the
Agency considered it as a testing issue, and part of the waste
generator's obligation to determine whether their waste is RCRA
hazardous (see 40 CFR 262.11). In 1985, the Agency published the
``paint filter liquids test'' (PFT) for identifying wastes containing
free liquids (Method 9095; 50 FR 18372, April 30, 1985), and
recommended its use for distinguishing aqueous from nonaqueous wastes.
However, a year later, EPA expressed concern about the reliability and
precision of the PFT for separating liquids from solids when it
proposed the Toxicity Characteristic Leaching Procedure (TCLP) test,
and instead proposed the use of pressure filtration for separating
solids from liquids in that test (June 13, 1986; 51 FR 21681). In
letters in 1989 (see docket for letter to Mr. Wagner) and 1990 (see
docket for letter to Mr. Wyatt) the Agency urged the use of the EP Tox
test pressure filtration procedure (Step 7.15; Method 1310) for
determining whether wastes contained liquids, but also noted that the
paint filter test could be used to show that a waste was liquid or
aqueous (i.e., a positive determination), but not to show a waste was
not liquid or aqueous (i.e., a negative determination). Letters in 1992
(see docket for letters titled `` `Aqueous' as Applied to the
Corrosivity Characteristic'' and ``Alcohol-Content Exclusion for the
Ignitability Characteristic'') and 1993 (see docket for letter to Mr.
Parsons) noted that aqueous wastes need not be liquid, and identified
suspensions, sols or gels for which pH could be measured as subject to
the corrosivity characteristic. In a 1993 rule proposal updating SW-
846, the Agency stated that method 9095 could be used only to
demonstrate that a waste is aqueous, and that pressure filtration is
necessary to show that a waste is not aqueous (58 FR 46054, August 31,
1993), and proposed to revise the SW-846 guidance for implementing the
hazardous characteristics to reflect this. However, in finalizing these
proposed revisions to SW-846, the Agency considered industry concerns
that the proposed revision to the characteristics implementation
guidance was insufficiently clear and determined not to revise the
guidance. The Agency also reiterated its assessment of PFT use: that
wastes producing no liquid using Method 9095 should be subsequently
subjected to the more definitive method for separating liquids from
solids, pressure filtration, as described in Step 7.2.7 of Method 1311
(the TCLP test; 60 FR 3089 and 3092, January 13, 1995).
As this issue is tangential to the petitioners' requests for
regulatory change, the Agency is proposing no changes to its guidance
at this time. The Agency may further consider this issue in the course
of revising and updating the SW-846 analytical methods in the future.
D. Other Potentially Relevant Incidents
The purpose of this analysis is to identify whether currently
unregulated wastes are causing harm that could be effectively addressed
by RCRA regulation (``damage cases.'') The petition presents several
incidents the petitioners consider to be waste-management damage cases.
As explained above, the evidence presented in the petition does not
appear to justify a regulatory change. In addition to the incidents
presented by the petition, the Agency sought to identify incidents of
corrosive injuries (i.e., chemical burns) to workers or others that may
be attributable to exposure to corrosive materials. In support of
revisions to RCRA's regulatory definition of solid waste, the Agency
searched for damage cases involving mishandling of wastes at recycling
facilities. Several of the 208 cases identified mishandling of
``corrosive or caustic wastes'' (primarily at drum reconditioning
operations); no corrosive injuries to individuals were reported, and
the pH of the materials was not identified, so it is not possible to
know whether these wastes were in fact RCRA hazardous (EPA 2007; An
Assessment of Environmental Problems Associated with Recycling of
Hazardous Secondary Materials). A 2015 update of this study similarly
identified incidents at several drum reconditioning operations in which
caustic solutions were mishandled, but no corrosive injuries to workers
were reported (EPA 2015, updating ``An Assessment of Environmental
Problems Associated with Recycling of Hazardous Secondary Materials'').
The Agency also reviewed a worker accident database compiled by
OSHA (available by using key word ``chemical burn'' at https://osha.gov/pis/imis/accidentsearch.html). While a number of chemical burns were
identified in the database, only a few contained enough detail to know
the pH of the material, and all but one of the cases also involved
heated materials (most at 136-295 [deg]F, and one above 800 degrees
[deg]F), making it difficult to attribute the resultant injuries solely
to the corrosive properties of the materials. In the case that did not
involve heated material, an employee got chemical burns when exposed to
effluent with pH estimated to be 9.9 from a clarifier tank leak,
although the material was not identified. In light of the pH value,
petitioners' proposed regulatory change would still not have captured
this material as characteristic waste.
The Agency also has information describing a 1999 incident in which
an employee of a pulp and paper plant apparently slipped and fell into
black liquor sludge at the edge of a concrete pad on which it was being
stored (see docket materials related to Mr. Matheny). The employee was
knocked unconscious, and, as he was working an overnight shift, lay in
the material for several hours before being found by co-workers. He
suffered chemical burns on more than 50% of his body, and died from his
injuries. While this material apparently contained enough absorbed
water to cause injury (although the water content was not tested),
subsequent information indicated that it passed the paint filter test,
and so was not considered to be an aqueous waste under the RCRA
corrosivity regulation, and was therefore determined to be outside the
scope of the regulation. This may be an instance in which a high sodium
concentration in the waste interfered with testing its pH, as it showed
a pH reading of 12.45 when tested directly, but with 10% water added to
the sample to reduce the sodium interference, its pH was 12.95. Rather
than providing support for expanding the definition of corrosivity to
include nonaqueous materials however, the Agency believes this damage
case may illustrate the value of clarifying the Agency's approach to
determining what wastes are aqueous. As mentioned above in section
IV.2.C, the Agency may further consider the issue of testing which
wastes are aqueous in the course of revising and updating the SW-846
analytical methods in the future.
[[Page 21308]]
V. EPA's Conclusions and Rationale for Tentative Denial of the Petition
In urging the Agency to expand the scope of the RCRA corrosivity
characteristic, the petition advances a number of arguments. However,
the petition fails in several ways to demonstrate that a regulatory
change is warranted. While the petition demonstrates that there has
been human exposure to materials identified by the petition as being of
concern, such as concrete dust and CKD, it fails to identify injuries
of the type and severity addressed by the RCRA corrosivity
characteristic that have resulted from these exposures. The injuries
that did occur to those exposed to the WTC dust have been attributed to
the dust as a whole, but cannot reliably be attributed to any one
property of the dust. While WTC first responders and demolition workers
clearly have suffered adverse health effects resulting from WTC dust
exposure, none of the published research on this population reviewed by
the Agency has identified gross tissue damage of the kind incorporated
into the RCRA and other regulatory and guidance definitions of
corrosivity (e.g., dissolving of skin proteins, combining with
cutaneous fats, or chemical burns). WTC dust and concrete and cement
dust may be respiratory irritants, but do not appear to be corrosives.
Further, many of the dusts identified as of concern often exhibit pH
values below the pH 11.5 value advocated in the petition. And finally,
the petition fails to demonstrate that the hazards posed by the WTC
site dust could have been reduced or controlled through RCRA
regulation.
The petition also argues that pH 11.5 is a widely used presumptive
standard for identifying material as corrosive, but fails to identify
that corrosive injury in animal tests remains the fundamental basis for
corrosivity classification, and that pH 11.5 is used as an optional
screening value that may be rebutted by in vivo or various in vitro
test data. The use of pH 11.5 in these regulations and guidances is
fundamentally different from how the pH 12.5 value is used in the RCRA
corrosivity characteristic regulation, and such use does not set a
precedent for defining corrosivity under RCRA. Significant precaution
can be incorporated into these flexible evaluation approaches without
resulting in unwarranted regulation, because the presumption of
corrosivity can be rebutted. RCRA regulations do not include such
flexibility and are not rebuttable; a waste meeting the hazardous waste
characteristics regulatory criteria (and not otherwise excluded from
regulation) is RCRA hazardous, which would trigger the entire RCRA
cradle-to-grave waste management system. As noted in the discussion
previously, the RCRA corrosivity characteristic reflects the particular
concerns of waste management in the United States.
One of the Agency's tentative conclusions in evaluating the
petition and related materials is that while the dusts identified by
the petition as being of concern are not corrosive materials, they
appear to be irritant materials. This raises the question of whether
the Agency should consider a new hazardous waste characteristic that
would identify and regulate irritant wastes. However, this particular
question falls outside the scope of the current petition. Moreover,
there remain significant questions about whether RCRA waste management
procedures would address any of the exposures identified in the
petition.
Finally, the hazardous characteristics regulations are not the only
RCRA authority the Agency has for addressing risks related to waste
management. If wastes generated by a particular industry, or a
particular waste generated by a number of industries, were identified
as posing corrosive risks to human health or the environment that could
be effectively addressed by RCRA regulation, the Agency could initiate
a hazardous waste listing rulemaking to regulate that waste. Given the
lack of evidence to demonstrate that a wholesale change of the pH
threshold in the corrosivity regulation is warranted, the listing
approach would effectively address a specifically identified waste
without running the risk of over-including wastes that have a pH
greater than 11.5 without demonstrating corrosive properties.\24\
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\24\ In particular instances, RCRA 7003 authority can also be
used to address situations posing threats of imminent and
substantial endangerment from waste mismanagement.
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VI. Request for Public Comment on EPA's Tentative Denial of the
Petition
As part of this document, the Agency is soliciting public comment
and data and other information on the issues raised by the petition.
These include information on possible health impacts of the current
corrosivity regulation (if any), as well as health benefits (if any)
that may be anticipated were the Agency to grant the petition's
proposed regulatory changes. Further, the Agency is requesting public
comment on any other issues raised by this tentative decision to deny
the petition, as well as additional information on the types and
amounts of waste that may be newly regulated, and the potential cost of
such management, were the agency to grant the proposed regulatory
changes. Stakeholders intending to provide comments or information to
the Agency in this matter are encouraged to review the petition and its
supporting documents in their entirety to ensure that they identify any
issues not discussed here that they may find of interest.
VII. References
The full bibliography for references and citations in this action
can be found in the docket as a supporting document.
List of Subjects in 40 CFR Part 261
Environmental protection, Characteristic of corrosivity, and
Characteristics of hazardous waste.
Dated: March 30, 2016.
Mathy Stanislaus,
Assistant Administrator, Office of Land and Emergency Management.
[FR Doc. 2016-08278 Filed 4-8-16; 8:45 am]
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