Hazardous Waste Determination
This page will help you determine if a given waste material
must be classified as hazardous for your healthcare facility. The rules are spelled out in the Resource
Conservation and Recovery Act (RCRA), and in the large body of regulations
developed by the Environmental Protection Agency to implement RCRA.
It is important to know the correct classification of all of
your facility's waste. The reason is that different sets of rules will
apply to your facility depending on the total amounts of each type of hazardous
waste that you generate per month. Large quantity generators operate under
more stringent rules than small quantity generators. The information
on this page will help you determine what to count toward the total.
Once you have determined the types and amounts of hazardous waste generated per month at your facility, you will be able to find which rules apply to your facility by using the information provided on the page "Managing Hazardous (RCRA) Wastes" (see Generator status, EPA ID).
Please note that the regulations in your state may be different
in some respects from the federal regulations. Consult the VetCA
State Hazardous Waste Locator to find more information on your state's
hazardous waste regulations.
Outline of the six steps
EPA recommends that you follow a six step process to determine
whether a waste is hazardous. The steps are listed below, expressed as
a series of questions:
The steps are discussed in some detail in the following sections,
with an emphasis on issues that would typically arise in healthcare facilities. Because
the issues can get complicated, the sections also provide links to more detailed
information.
Is it "solid waste"?
The first step in determining if a material is a hazardous
waste is to determine whether it is classified as a "solid waste". The
rules specify that a material cannot be a hazardous waste unless it is first
determined to be a solid waste.
You probably think you learned what a solid is in eighth
grade science class. The folks who wrote the RCRA rules weren't in that
class. This is the first of many times when the RCRA rules can be confusing. "Solid" for
RCRA purposes doesn't mean what it means to you and me. The regulatory
usage of the term "solid" in this context is closer to the sense
of the word "contained".
RCRA states:
"The term "solid waste" means any garbage,
refuse, sludge from a waste treatment plant, water supply treatment plant,
or air pollution control facility, and other discarded material including
solid, liquid, semisolid or contained gaseous material…" (US
Code, Title 42, paragraph 6903, emphasis added)
So even gaseous material can, in some circumstances, qualify
as a "solid waste".
Most materials of concern in healthcare facilities will fall
under the "other discarded material" category in the RCRA definition. So
how can you recognize when material has been "discarded"? According
to EPA usage, there are three types of "discarded" material:
- Abandoned
- Recycled
- Inherently waste-like
Abandoned: In simplest terms, a material is
considered "abandoned" if you plan to get rid of it. It clearly
applies to material you have already disposed of, or that you have incinerated. It
also applies to material that is being accumulated, stored and treated for
eventual disposal or incineration.
It's not hard to imagine situations in which a healthcare facility and
an inspector might have a difference of opinion about whether some stored material
is or is not a waste. Here are some of the questions the inspector might
ask:
- Does the facility have a use for the material?
- Does the facility treat the material as if it was a valuable
commodity?
- Does the facility plan to give it to someone else that
has a use for it?
For example, suppose the inspector comes across a 55 gallon
drum of solvent in the basement that is rusted, corroded and sitting in a pool
of water. Even if the solvent is a valuable commodity, the facility is not 'treating' it
as such. They are treating it as waste. The inspector would be likely
to consider it abandoned.
Recycled: Specific
types of recycled materials are considered 'discarded' and are
therefore solid waste.
A material is normally considered to be discarded if it is:
- Used in a manner constituting disposal
- Burned for energy recovery
- Reclaimed
- Accumulated speculatively
"Speculative accumulation" refers to all those
piles of material that you fully intend to recycle, but haven't quite gotten
around to. EPA will generally consider that your material is being "accumulated
speculatively" if you cannot demonstrate a viable market for it, or if
you have not recycled at least 75% of it in a given calendar year.
A material is also considered discarded if it is accumulated,
stored or treated before recycling.
Please note that some materials that are reclaimed are not
considered solid wastes under RCRA, even if they exhibit a characteristic of
hazardous waste (like ignitability or corrosivity -- see below). These
include:
- Commercial chemical products
- Sludges
- By-products
Similarly, commercial chemical products that are speculatively
accumulated are also not solid wastes under RCRA.
Inherently waste-like: Certain materials pose
such a significant threat to human health that they are deemed "inherently
waste-like" and are always considered solid wastes. A standard example
is any material containing dioxins -- that is in fact the only example so far.
In case of dispute: It
can sometimes happen that an inspector will consider that a particular material
has been "discarded", and the facility will not agree. In
such a case, the facility will have to submit appropriate documentation to
the inspector. For example, if
you are claiming that the material is a valuable commodity or has another
use, you will need to show that you have a market for it, or that someone
is actually taking and using it beneficially, etc.
Is it excluded?
The next step is to determine if the waste qualifies for
an exclusion from RCRA regulation. There are four main avenues:
- Solid waste exclusion
- Solid waste variance
- Hazardous waste exclusion
- Recycling
Solid waste exclusion: There are some materials
that are specifically excluded from the definition of "solid waste". You
can find a full listing in 40
CFR 261.4(a), but most cases are not likely to be relevant to healthcare
facilities. Examples include solid or dissolved material in domestic
sewage, certain nuclear materials (already covered under the Atomic Energy
Act), and a long list of materials from industrial and agricultural processes.
Regarding the case of domestic sewage, please be aware that
this exclusion does not give you an opportunity to throw questionable waste
down the drain and then claim that it's excluded under 40 CFR 261.4. The
purpose of that exclusion is to allow facilities like municipal sewage treatment
plants (known as "publicly owned treatment works", or POTWs) to deal
with their waste streams without having to comply with RCRA requirements that
would be inappropriate for them. Veterinary facilities must have a written
agreement from their POTW to accept any waste that might qualify. In
addition, the waste must actually reach the POTW to qualify for the exclusion
-- if it gets trapped in the pipes or evaporates on the way, it does not qualify.
Solid waste variance: Another possible way to
keep a particular material from being regulated under RCRA is to apply for
a solid waste variance. This option applies to:
- Materials accumulated speculatively without sufficient
amounts recycled
- Materials reclaimed and reused within original process
- Materials incompletely reclaimed
In order to use these variances, you will have to submit
documentation demonstrating your case. If your state is authorized to administer
the variance program, send the documentation to the director of your state
agency. Otherwise, send it to the EPA Regional Administrator. You
can find the rules governing solid waste variances in 40 CFR, sections 260.30, 260.31 and 260.33.
Hazardous waste exclusion: Even if a material
is indeed a solid waste, and even if it does not qualify for a solid waste
variance, the regulations provide yet another possibility for exclusion. The
solid waste might be excluded from being considered a "hazardous waste" if
it falls under any of the exemptions listed in the next subsection of the Code, 40
CFR 261.4(b).
Most of the hazardous waste exclusions listed in that subsection
are not relevant to healthcare facilities, but here are three possibilities
that may apply to you:
- Household waste (see 261.4(b)(1))
- Waste from university dormitories, military housing,
and any doctor's housing that you may have at your facility will
fall under this exclusion.
- However, note that only wastes normally found
in a household would fall under this exclusion.
- Nursing homes do not qualify for
this exclusion
- Used Freon (see 261.4(b), paragraphs (11)
and (12))
- Samples of solid waste collected for the purpose
of testing and treatability studies (see 261.4(d),(e), and (f))
Recycling Exclusion: Certain hazardous wastes are exempt from regulation when recycled. Examples that may apply to veterinary facilities incude cathode ray tubes (CRTs) and scrap metal. For more information, see EPA's Hazardous Waste Recycling Regulations.
Is it listed?
The RCRA regulations include four lists of materials, designated
with the letters F, K, P, and U. (The origin of the letter designations
is obscure.) If the waste you are screening appears on the any of the
lists, your task is done -- it's hazardous.
What distinguishes the lists?
The F- and K-lists cover
process wastes -- materials that have been used in processes carried out in
your facility. The P-
and U-lists cover unused chemicals that are being discarded for various
reasons; for example, they may be off-specification or expired, they
may have been spilled and cleaned up, or they may be residues left in containers.
The distinction between the two process waste lists (F and
K) lies in their specificity. The K-list deals with very specific processes
that are typically carried out by one manufacturing sector only, such as organic
chemical manufacturing or petroleum refining. The F-list covers general
processes that might occur in a range of sectors, such as solvent use, metal
finishing processes, and wood preserving.
The unused chemicals lists (P and U) differ in their degree
of risk. P-listed wastes are "acutely toxic", meaning that
they can cause death
or irreversible illness at low doses. U-listed wastes are "toxic": they
are still regarded as hazardous, but some of the more drastic regulations that
apply to the P-list do not apply to U-listed wastes.
The P- and U-lists do not apply to manufactured articles
that contain a P- or U-listed waste (e.g. mercury thermometers) or to products
that contain more than one active ingredient. Such wastes might
still be hazardous, but their hazard classification would fall under a different
category (most likely the toxicity characteristic discussed in the next
section).
K-list
Veterinary facilities do not carry out manufacturing processes,
and would not typically generate any K-listed materials.
F-list
The first five F-listed categories, F001
- F005, cover a range of solvents used in a variety of applications. A
healthcare facility might generate F-listed solvents such as acetone, methanol,
toluene, xylene, and methylene chloride from departments such as:
- Pathology laboratory
- Histology laboratory (xylene)
- Pharmacy
- Morgue
- Maintenance shops (degreasers)
The rest of the F-list is not likely to apply to healthcare
facilities.
P-list
If you are interested in reducing the hazardous waste generated
in your facility, eliminating or finding substitutes for P-listed chemicals
is a good place to start. A small quantity -- one kilogram -- of a P-listed
waste can cause a facility to be classified as a "large
quantity generator," and to have to comply with more stringent rules
as a consequence.
The P-list includes
about 239 different "acutely toxic" substances, listed under about
135 different waste codes. (Some codes cover several substances.) VetCA
has identified 15 of these that you might expect to find in a healthcare facility. They
are listed below, along with their waste codes and typical uses associated
with each. The CAS numbers for these compounds can be found in the official
list at 40
CFR 216.33.
Please note that our short list is not meant to be exhaustive,
and also that states may impose restrictions that apply to wastes beyond those
listed in the federal list.
P-listed chemicals commonly found in healthcare
facilities
Material |
Code |
Use |
Arsenic Trioxide |
P012 |
antineoplastic |
Cyanide Salts |
P030 |
laboratory |
Nicotine |
P075 |
smoking cessation, nicotine patches, etc. |
Potassium Silver Cyanide |
P099 |
bactericide |
Warfarin >0.3% |
P001 |
blood thinner |
Physotigmine Salicylate |
P188 |
glaucoma |
U-list
The U-list includes
about 472 distinct materials, listed under about 247 different waste codes. (As
with the P-list, the same code can refer to several different materials.) VetCA
has identified 66 of them that you might expect to find in a healthcare setting,
and has listed them, along with their waste codes and typical uses, below. The
CAS numbers for these compounds can be found in the official list at 40
CFR 216.33.
Our list is not meant to be exhaustive. States may
impose restrictions that apply to wastes beyond those listed in the federal
list.
U-listed chemicals commonly found in healthcare
facilities
Material |
Code |
Use |
Mitomycin C |
U010 |
antineoplastic |
Chloral hydrate (CIV) |
U034 |
seditive |
Cyclophosphamide |
U058 |
antineoplastic |
Daunomycin |
U059 |
antineoplastic |
Lindane |
U129 |
lice, scables |
Melphalan |
U150 |
antineoplastic |
Selenium sulfide |
U205 |
anti-fungal, dandruff |
Streptoztocin |
U206 |
antineoplastic |
Benzidine dichloride |
U243 |
pathology laboratory |
Chemotherapy agents
Many of the chemicals used to treat cancer patients during
chemotherapy fall on either the U or P lists. These agents are often
referred to by their brand names rather than the chemical designations appearing
on the lists. For your convenience, VetCA has compiled a list
of some common brand names, together with their chemical names and RCRA waste
codes. Please note that since new products may be introduced at any
time, the list may not include all brand names composed of RCRA listed chemicals.
Is it characteristic?
SDS 101 - Reading and Using Safety Data Sheets
AVMA has prepared this very useful summary to aid in understanding the Safety Data Sheets that may accompany chemical products you purchase. |
EPA's Substance Registry Services (SRS) can be a useful tool when performing hazardous waste determinations. As with any informational resource, it has limitations (e.g., does not include state-specific information) and potential errors. Therefore, be certain to verify your findings with other sources while making determinations. |
Designating hazardous materials by listing them explicitly
is fine as far as it goes, but that strategy will never go far enough. There
are many more materials used in commerce than could ever be covered in a manageable
set of lists. Furthermore, some mixtures of materials can be just as
hazardous as single materials, while others can be relatively benign. Given
the astronomical number of possible combinations of materials, listing is not
a practical way to account for mixtures.
To cope with these possibilities, RCRA provides another set
of criteria for classifying a waste as hazardous. Whatever its composition,
a waste is considered hazardous by RCRA if it exhibits any of four characteristics:
They are discussed in greater detail below.
Note: Even if a waste has been determined
to be a listed waste, it should also be evaluated to see if
it also qualifies as a characteristic waste. Additional rules may apply
to it in some cases.
Ignitability
Ignitable wastes pose hazards because they either catch fire
readily themselves, or (in the case of strong oxidizers) promote fires.
A waste is considered "ignitable" under RCRA if
it is a:
- Liquid with flash point under 140°F, or
- Non-liquid, but susceptible to vigorous burning by friction,
water absorption, or spontaneous chemical change, or
- Flammable compressed gas, or
- Strong oxidizer
(The "flash point" of a liquid is the temperature
at which the vapor above a pool of liquid will catch fire under a standard
set of conditions.)
Ignitable wastes commonly found in healthcare facilities include:
- Rubbing alcohol (if the alcohol concentration
exceeds 24%)
- certain mouthwashes including
Listerine' fall into this category
- Paregoric
- Methanol
- Silver nitrate
- Certain topical preparations such
as:
- Cleocin T topical solution
- Erythromycin topical solution
- Retin A gel
- collodion based preparations
- Certain injectable materials
The regulations covering the Ignitability characteristic
can be found in Title 40 of the Code of Federal Regulations, Part 261, Section
21 (40
CFR 261.21).
Corrosivity
Corrosive wastes include liquids with pH less than 2 or greater
than 12.5, or that corrode steel faster than a quarter-inch per year at 55°C.
Examples of corrosive wastes occurring in healthcare facilities include
concentrated solutions of acetic acid or sodium hydroxide (lye).
The regulations covering the Corrosivity characteristic can
be found in Title 40 of the Code of Federal Regulations, Part 261, Section
22 (40
CFR 261.22).
Reactivity
Reactive wastes include:
- Materials that generate toxic gases in contact with water
- Wastes that contain cyanide or sulfide and can release
toxic gases in contact with strong acids or bases
- Explosive materials, or materials that are explosive
when heated
Reactive wastes that may be found in healthcare facilities include:
- Lithium-sulfur batteries
- Dry picric acid
- Explosive when dry -- should be handled with extreme
care
- May be found in histology laboratories
- A component of the tissue preservative Bouin's Solution
- Nitroglycerin formulations (see
the VetCA Pharmaceuticals page for more
information on nitroglycerin)
- Ethylene oxide
Toxicity
The RCRA sense of toxicity is somewhat indirect. The
concern is not so much with the toxic properties of the wastes themselves as
with the extent to which toxic materials can leach out of the wastes if they
are exposed to water in the environment.
To measure this potential, the rules specify a test called
the Toxic Characteristic Leaching Procedure, or TCLP (EPA
Method 1311). The test is designed to give some indication of how
readily various materials would tend to leach into groundwater if the waste
were placed in a landfill. One form of the test involves subjecting the
waste to a mild acetic acid solution (about the strength of household vinegar)
at room temperature for 18 hours. The solution is then tested for the
presence of any of the so-called "D-listed" chemicals. For
each of the chemicals, the RCRA rules specify a threshold level (concentration). If
any of the chemicals is present in the solution at a concentration above its
threshold level, the waste is considered a toxic hazardous waste.
This
link will take you to the most recent available version of the complete
D-list.
Examples of healthcare facility wastes that are considered by RCRA
to have the toxicity characteristic include:
- Mercury
- Mercury compounds, such as thimerosal, used as a preservative
in vaccines
- Phenylmercuric acetate
- Arsenic compounds
- Barium compounds
- Certain compounds containing other
metals, including
- Chromium
- Cadmium
- Selenium
- Silver
- Chloroform
- M-cresol
- Lindane
Is it a mixture?
If a hazardous waste and a non-hazardous waste are mixed,
the resulting mixture may inherit the hazardous classification. The rules
are different for listed and characteristic wastes.
- Mixing in any amount of a listed waste
will cause the mixture to be considered hazardous.
- Mixing in a characteristic waste will cause
the mixture to become hazardous only if the mixture itself exhibits the characteristic.
There are various exceptions and exemptions
-- see, for example, the RCRA
Orientation Manual listed in the More Resources section for additional
information and references.
A special waste mixture termed "mixed-waste" contains both radioactive and hazardous waste. As a result, both treatment and regulation are complex. Two different regulatory frameworks and three federal agencies are involved: EPA, the Nuclear Regulatory Commission (NRC), and the Department of Energy (DOE). These agencies have largely resolved the administrative, regulatory, and technical issues that have faced government and private sector mixed-waste generators.
Mixed waste requires additional labeling and special disposal. Not all hazardous waste brokers are authorized to handle mixed waste.
Additional information and guidance on mixed-waste:
Another special mixture, termed "dual wastes" is a combination of hazardous waste and regulated medical waste (infectious, potentially infectious, or sharps depending on state regulations). Examples include non-empty syringes or IV lines containing hazardous waste pharmaceuticals with needles attached. Additionally, if someone mistakenly disposes of hazardous waste into the RMW container, the entire container is now dual waste. Dual waste requires additional labeling and special disposal. Not all hazardous waste brokers are authorized to handle dual waste.
Is it derived from a
hazardous waste?
Similar rules apply to wastes that are derived from listed
or characteristic hazardous wastes as residues from waste treatment processes. Since
most healthcare facilities are not hazardous waste Treatment, Storage, and
Disposal (TSD) sites (and thus should be sending all hazardous wastes to a
licensed TSD facility), this consideration is unlikely to apply to you.
More resources
Related EPA Policy Memos
- Regulatory Status of Antineoplastic
Drug Wastes. This
letter is in response to a request for clarification of the status of certain
antineoplastic drug
wastes. The request was for an interpretation of 40 CFR 261.33, with respect
to excess antineoplastic drug formulations which are not needed and thus
are discarded. (4/25/1988).
- Containers Used To Hold Listed
Chemotherapy Drugs. This letter responds to a question regarding the regulatory status of chemotherapy
drugs and related
supplies; in particular, the question whether the weight of the "empty" vial
should be included in determining the amount of drug residues to be disposed.
(6/16/1987)
- Returned Pharmaceutical Products. This responds to a letter requesting
a determination regarding the regulatory status of pharmaceutical products
that are returned
by the dispensers of these products to the manufacturers, wholesalers,
or to a third-party service company that will facilitate the processing,
crediting,
and, if needed, appropriate disposal of the returned products. (5/16/1991)
- Definition
of Solid Waste and Reclamation. A distributor of a U-listed commercial
chemical product finds that the product is no longer saleable. (8/2005)
- Returned
Pharmaceutical Products. This responds to a letter requesting a
determination regarding the regulatory status of pharmaceutical products
that are returned by the dispensers of these products to the manufacturers,
wholesalers, or to a third-party service company that will facilitate
the processing, crediting, and, if needed, appropriate disposal of the
returned products. 5/16/1991
- Mercury Thermometrs Reclaimed Off Spec and Broken.' This is in response
to a letter dated March concerning the regulatory status of off-spec
and broken mercury thermometers that are reclaimed under the Resource
Conservation and Recovery Act hazardous waste rules. 4/2/1986.
- Waste Listings for Commercial Chemical Products Mercury. This letter
is in response to a telephone conversation and letter, both dealing
with waste listings for commercial chemical products (mercury thermometers).
(11/2/1988)
- P and U Listed Wastes. This letter is in response to a letter, in which
someone asked for clarification of Resource Conservation and Recovery Act
(RCRA) regulations as they pertain to "U" and "P" listed wastes. (4/21/1989)
The definition of "solid waste" appearing
above can be found in the US Code. A different definition appears in
the Code of Federal Regulations 40
CFR 261.2. The US Code contains the text of laws passed by
Congress, while the Code of Federal Regulations contains the text of rules
written by executive agencies. The former is the definition most frequently
cited by EPA.
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