United Stales
Environmental Protection
Healthcare Environmental Assistance Resources
Pollution Prevention and Compliance Assistance
for Healthcare Facilities
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ENVIRONMENTAL SELF-ASSESSMENT
FOR
HEALTH CARE FACILITIES
A QUICK AND EASY CHECKLIST OF
POLLUTION PREVENTION MEASURES
FOR HEALTH CARE FACILITIES
February 2000
Prepared for Health Care Facilities in New York State
by
New York State Department of Environmental Conservation
Pollution Prevention Unit
George E. Pataki, Governor
John P. Cahill, Commissioner
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ACKNOWLEDGMENTS
The New York State Department of Environmental Conservation (NYSDEC), Pollution
Prevention Unit would like to acknowledge the cooperation of the U.S. Environmental Protection
Agency Region n Office; NYS Department of Health, Albany, NY; Strong Memorial Hospital,
Rochester, NY; Citizens' Environmental Coalition, Albany, NY; Beth Israel Medical Center,
New York, NY; and the New York State Nurses Association, Latham, NY in the preparation of
this document. The Pollution Prevention Unit would also like to acknowledge the following
NYSDEC programs for their assistance in the preparation of the final copy: Division of Solid and
Hazardous Materials; Division of Air Resources; and the Division of Public Affairs and
Education, Bureau of Publications and Internet.
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TABLE OF CONTENTS
Introduction 1
The Environmental Self-Assessment for Health Care Facilities 2
Self-Assessment Checklists 3
Getting Started 3
Procurement of Commodities and Services 4
Medical Waste Incinerators 8
Hazardous and Solid Wastes 9
General Recommendations 9
Ethylene Oxide (EtO) 11
Glutaraldehyde 12
PVC (polyvinyl chloride) Plastics 13
Solvents 14
Mercury 16
Chemotherapy & Antineoplastic Chemicals 18
Batteries 19
Lamps 21
Photographic Chemicals & Scrap Film 23
Formaldehyde/formalin 24
Radioactive Waste 25
Medical Waste Stream 26
Recycling & Reuse 29
Housekeeping 30
Facility Maintenance 31
Next Steps 34
A Resource Guide 35
Trade Organizations 35
Local Assistance 37
State Assistance NYSDEC 38
Other State Agencies 40
Federal Assistance 41
Resources on the Internet 41
Appendices
A. Health Care Facilities Instruments and Products That May Contain Mercury ... 43
B. Alternative Treatment Technologies 45
References 46
If you have any questions or comments regarding
the use of this self-assessment please contact:
NYS Department of Environmental Conservation
Pollution Prevention Unit,
50 Wolf Road, Room 298
Albany, NY 12233-8010
Phone: (518) 457-2553 or (800) 462-6553
FAX: (518) 457-2570
Internet Address: http://www.dec.state.ny.us
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INTRODUCTION
The purpose of this manual is to assist
New York State Health Care Facilities in the
development of an effective pollution
prevention program or improve programs
which may already be in place. Implementing
an effective pollution prevention program
requires a continuous commitment by a wide
range of health care personnel.
Health care facilities that practice
pollution prevention benefit the environment
by reducing the volume and toxicity of
material at its source before it becomes a
waste. In addition, there are many benefits
that health care facilities attain for
implementing pollution prevention practices.
Some of these include:
* Improved environmental compliance.
* Protection of human health by reducing
the exposure of employees to chemicals in
the workplace.
* Enhanced community relations by
demonstrating a commitment to
environmental protection.
* Economic benefits resulting from
pollution prevention products that reduce
and recycle waste.
* Avoidance of long term liability.
(Remember, you are responsible for
proper management and disposal of the
wastes that you generate.)
* Positive press coverage for the health care
facility.
* Increased employee morale resulting from
a healthier and safer work environment.
The Environmental Self-Assessment for
Health Care Facilities is a tool to help
evaluate a health care facility's present
performance in preventing pollution and
identify opportunities for additional pollution
prevention measures. If your facility has
limited resources, the self-assessment should
serve as a preliminary self-diagnostic tool that
can be used before seeking any outside
assistance.
Technical assistance and pollution
prevention approaches may be available from
vendors, consulting engineers, professional
organizations and the Internet. Assistance is
also available from state and local
environmental agencies, such as the New
York State Department of Environmental
Conservation's Pollution Prevention Unit and
the NYSDEC regional multimedia pollution
prevention coordinators. The New York State
Environmental Facilities Corporation also
provides free, confidential technical assistance
to health care facilities that qualify under its
Small Business Assistance Program (see "A
Resource Guide," page 35, for a list of
agencies, organizations and sites on the
Internet that can provide technical information
and assistance).
An environmental self-assessment can
prove worthwhile as a preventive strategy. It
can identify procedure changes and
housekeeping measures that will prevent
damage to the environment and help your
health care facility comply with environmental
requirements.
The checklists found in the self-
assessment are designed to test a facility's
performance in pollution prevention, waste
reduction and recycling. For information
regarding compliance with environmental
rules and regulations, contact your regional
NYSDEC multimedia pollution prevention
coordinator and the NYS Department of
Health (see "A Resource Guide," page 35).
Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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THE ENVIRONMENTAL SELF-ASSESSMENT
FOR HEALTH CARE FACILITIES
The following checklist is a guide
primarily intended for use by laboratory
managers, administrators, environmental
compliance personnel, purchasing officers,
safety professionals, housekeeping managers,
waste management supervisors and industrial
hygienists involved with the day-to-day
activities in a health care facility. To
have a successful pollution prevention
program, routine environmental
self-assessments should be conducted. The
self-assessments will help identify
opportunities to incorporate pollution
prevention measures in all aspects of
administering medical services. Examples of
health care facility areas and activities to be
investigated can include, but are not limited
to, laboratory services, patient floors,
hemodialysis, intensive care and isolation
units, cafeteria, purchasing, radiology and
surgery areas.
Review each section of the self-
assessment with the manager and staff
members who are most familiar with that
particular activity in the facility. Responses to
the questions should show whether potential
hazards or polluting activities are occurring
that may be addressed by purchasing and
operational changes, equipment substitution or
changes to housekeeping procedures.
This self-assessment is only one in a series
of steps that your facility should take to
determine its regulatory compliance and to
identify suitable methods of waste reduction.
The checklist would be most effective when
used with related tools, such as workshops and
publications. For many facilities, the
self-assessment will likely be as useful as a
thermometer would be for a person with a
fever: the symptoms may be measured, but an
expert opinion may be needed to diagnose the
problem and develop corrective measures.
Following the completion of the self-
assessment, consult this guide for additional
information on the nature and type of
pollution prevention techniques successfully
applied by other health care facilities.
Progressive health care facilities will use
the environmental self-assessment to achieve
the following goals: evaluate current pollution
prevention practices and develop an ongoing
pollution prevention program or strengthen a
program which has already begun.
Don't be discouraged by the sometimes
difficult process of identifying and addressing
environmental problems. Over the long haul,
the measurable benefits of conducting and
responding to regular environmental
self-assessments may include reductions in:
environmental hazards, exposure to
enforcement, fines, insurance rates, waste
handling costs and accidents. Benefits may
also include an improved compliance record,
improved worker safety and a healthier work
environment. Making the effort to reduce the
generation of materials at the source, or
recycling waste on- or off-site demonstrates
that you are being environmentally
responsible. In addition, pollution prevention
programs support a health care facilities
mission of protecting the health of it's patients
and staff.
The Environmental Self-Assessment for
Health Care Facilities provides useful
information, but there is no guarantee,
expressed or implied, that the information will
identify all possible conditions and
opportunities for pollution prevention.
Compliance with environmental and
occupational safety and health regulations is
not the focus of this document and is the
responsibility of the individual health care
facility.
Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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SELF-ASSESSMENT CHECKLISTS
Review each question carefully and check the appropriate box. A Yes answer indicates that your
health care facility has incorporated pollution prevention, waste reduction and recycling measures
into its day-to-day activities. A No or Can't Determine answer indicates that an opportunity to
prevent or reduce pollution may exist. Take notes on the questions that received a No or Can't
Determine response.
Use this self-assessment to create a working list of pollution prevention, waste reduction and
recycling opportunities that should be explored in greater detail. You are encouraged to consult with
the Department of Environmental Conservation's regional multimedia pollution prevention (M2P2)
coordinators, the Pollution Prevention Unit located in Albany, medical associations, vendors and
other pollution prevention coordinators for additional information and assistance (see "A Resource
Guide," page 35, for a list of agencies and organizations that provide technical assistance on
pollution prevention).
Getting Started
Yes No Not Can't
Applicable Determine
Has a project leader been designated who will Q
be responsible for collecting information and
organizing the self-assessment?
Have all of the areas in the health care facility Q
that will undergo the self-assessment been
identified? (Some facility areas to consider
include nursing, surgery, analytical and
clinical laboratories, patient floors, burn units,
hemodialysis, ICU, pathology, histology,
purchasing, maintenance, radiology,
admissions, medical equipment, cafeteria,
chemotherapy and antineoplastics, pharmacy,
nuclear medicine and autopsy.)
Have you established short-term and long- Q
term audit and implementation goals? (It may
be easier and more rewarding to initially
focus pollution prevention activities on
specific areas or waste streams at the health
care facility. The long-term goal should be to
eventually establish pollution prevention
programs for all applicable areas and waste
streams throughout the facility.)
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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Has a coordination team consisting of staff
members familiar with the daily operations of
their area been asked to assist in the self-
assessment?
Will the audit consist of a thorough review of
each area to identify the types, quantities and
rates of the waste generating activities?
(Preparing material balances for the targeted
activities is helpful for tracking the waste
streams.)
Yes
a
No
a
Can't
Determine
a
Not
Applicable
a
a
a
a
a
Procurement of Commodities and Services
Does the health care facility have a central
system in place for tracking and quantifying
the amount of chemicals purchased,
dispensed and disposed of?
Does the current inventory system minimize
the amount of waste that will be generated
due to overpurchasing ?
Upon arrival of purchased materials, is a
central receiving department or person in
charge for verifying that the order is correct?
Are records kept of chemicals, medical
supplies and equipment beginning with their
arrival, the history of their use and final
destination?
Are procurement of chemicals and medical
supplies done through a central department or
a person familiar with the health care
facility's pollution prevention and waste
reduction goals?
Yes
a
No
a
Can't
Determine
a
Not
Applicable
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Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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Are products and materials that are brought
into the facility by practitioners, who have
acquired them from vendors, identified and
tracked through a central department or a
person familiar with the health care facility's
pollution prevention goals?
Are the acceptance of free samples, which
most likely become waste, minimized?
Are smaller quantities, as compared to past
purchases, of infrequently used materials
purchased?
Is the inventory system designed to ensure
that purchased materials are used in a first-in
first-out order to avoid expiration of their
shelf life?
Are Material Safety Data Sheets (MSDS)
maintained and made readily available to
employees for all materials used in the health
care facility? (This is an OSHA requirement.)
Have employees been trained to safely handle
the types of packages and chemicals that the
health care facility receives?
Does the health care facility have a
procurement policy that requires vendors use
minimal, reusable, recyclable, or returnable
packaging containers when possible?
Does the health care facility have a system in
place to monitor the flow of shipments within
the facility from receipt of raw material to
disposal?
Has the health care facility considered
establishing a computer tracking system for
monitoring chemical inventories and wastes?
Does the health care facility use a standard
procedure for the labeling of chemicals and
wastes?
Yes
a
No
a
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Can't
Determine
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Not
Applicable
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Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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Do you use a supplier which will allow the
health care facility to return unopened,
surplus, obsolete or outdated supplies? (Note:
Returning some medical supplies may be
prohibited if the material is a hazardous waste
and destined for disposal instead of
evaluation/recycling by the manufacturer.
Please contact the NYSDEC, Division of
Solid and Hazardous Materials for further
guidance.)
Do you perform an inventory of the amount,
type, purchase date and location of all
chemicals on a regular basis?
Is the chemical inventory used to assure that
excess chemicals are not purchased?
Do you perform an inventory of all waste
streams on a regular basis?
Is the waste inventory used to keep track of
the types, amounts, locations and storage
times for wastes?
Does the health care facility have a
procurement policy that requires using
environmentally responsible products and
purchasing least toxic alternatives when
possible?
Does the health care facility have a
procurement policy that requires the purchase
of postconsumer recycled-content paper and
plastic where available?
Does the health care facility have a program
in place to phase out the purchasing of
devices and products containing PVC plastic
when alternatives exist?
Yes
a
No
a
Can't
Determine
a
Not
Applicable
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Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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Yes No Can't Not
Determine Applicable
Is the health care facility working towards Q Q Q
eliminating mercury waste generation by the
year 2005 as outlined in the Memorandum of
Understanding— Voluntary Partnership
between the American Hospital Association
and the Environmental Protection Agency?
(More information on this partnership can be
found on http://www.epa. gov/grtlakes/
toxteam/ahamou.htm )
Has the health care facility made a Q Q Q
commitment to purchase mercury-free
products whenever alternatives exist?
Are these efforts and commitments reviewed Q Q Q
regularly and are the results provided to the
staff?
Is there acknowledgment of pollution Q Q Q
prevention improvements and successes?
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 7 February 2000
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Medical Waste Incinerators
Emissions from medical waste incinerators can be a source ofdioxin, mercury, lead and
hydrochloric acid pollution. According to the Environmental Protection Agency, the
incineration of medical waste is one of the major contributors ofdioxin to the environment. In
September 1997, the Environmental Protection Agency issued guidelines to control air
emissions from hospital/medical/infectious waste incinerators. The New York State
Department of Environmental Conservation (NYSDEC) has implemented these regulations.
To meet these emission standards, hospitals may need to upgrade their incinerators with
effective air pollution control devices or switch to affordable and effective alternative
treatment technologies combined with pollution prevention strategies. Waste management
plans must be developed and submitted to the NYSDEC from those facilities with regulated
hospital/medical/infectious waste incinerators, as required in 40 CFR Part 60. (See
Appendix Bfor NYS Department of Health information regarding Alternative Treatment
Technologies.)
Have alternative technologies for treating
regulated medical waste*, such as autoclave
treatment, chemical/enzyme disinfection,
plasma/pyrolysis, thermal, biological,
heat/steam/electro/radiation or microwave
irradiation been explored to replace
incineration? (* Refers to regulated medical
waste as defined in the Public Health Law
1389
AA-GG-.
Has staff been informed of the environmental
and human health impacts of improper waste
segregation and disposal? (The improper
disposal of certain wastes can result in toxic
releases, therefore, employee education is
vital.)
Can your health care facility determine how
much of its waste stream is incinerated?
Lbs. per year:
Percentage of all waste: %
Has the health care facility taken steps to
eliminate the nonessential incineration of
medical waste?
Yes
a
No
a
Can't
Determine
a
Not
Applicable
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Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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Hazardous and Solid Waste
One of the best means of reducing and eliminating hazardous wastes that are generated or result
from a spill is through better operating procedures and preventive maintenance. When conducting
the self-assessment, keep in mind the follow ing pollution prevention ideas and practices which can
be applied at health care facilities of all sizes.
General Recommendations
Has your health care facility assessed whether
nontoxic alternatives exist for each hazardous
material utilized?
Has the quantity of hazardous waste being
generated each month been determined? (The
amount of hazardous waste generated and
stored each month will determine which of
the three categories of hazardous waste
generator applies to your health care facility.
The environmental compliance requirements
will differ for each category. Assistance in
determining your generator status and the
applicable regulatory requirements should be
directed to your regional NYSDEC office.)
Have all the wastewater discharges been
identified and evaluated to determine whether
they are managed properly? (If the facility
discharges directly into a municipal sewer
system you should check with your local
publicly owned treatment works (POTWS) to
determine if there are certain discharge
restrictions. Wastewater that is directly
discharged into surface water or groundwater
requires a State Pollutant Discharge
Elimination System (SPDES) Permit.)
Have employees been trained in the
hazardous waste regulations (e.g., labeling,
storage, spill prevention and manifesting
requirements) related to the job they are
doing?
Do you have a written spill prevention plan?
Yes
a
a
No
a
a
Not
Applicable
a
a
Can't
Determine
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Environmental Self-Assessment
For Health Care Facilities
A Checklist for Pollution Prevention
February 2000
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Have employees been trained in spill
reporting requirements? (Contact your
regional NYSDEC office for spill reporting
information.)
Are spill and cleanup kits available nearby?
Have employees been trained in identifying
waste types and appropriate waste
segregation?
Are all waste streams properly segregated and
labeled?
Are chemicals stored in accordance with
OSHA and manufacturers' recommendations?
Are chemical containers returned to the
supplier for reuse?
Are hazardous wastes stored in a central
location?
Are mechanical aids used in handling drums
to reduce spills?
Is one person responsible for tracking the
waste that is generated?
Do you label everything to avoid
contaminating waste streams that would
normally be nonhazardous? (Large quantities
of hazardous waste can be generated by
inadvertently mixing waste streams.)
Are containers kept closed, well organized
and away from people and equipment that can
cause it to spill? (Improper storage may cause
a health risk.)
Do you maintain a waste stream tracking
system which includes information on the
area of generation, quantity, waste
constituents, storage time, container and
ultimate disposal?
Yes
a
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No
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Can't
Determine
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Not
Applicable
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Environmental Self-Assessment
For Health Care Facilities
10
A Checklist for Pollution Prevention
February 2000
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Yes No Can't Not
Determine Applicable
Do you return obsolete or surplus supplies to Q Q Q Q
the vendor? (Note: Returning some obsolete
or surplus supplies may be prohibited if the
material is a hazardous waste and destined for
disposal instead of evaluation/recycling by the
manufacturer. Please contact the NYSDEC,
Division of Solid and Hazardous Materials
for further guidance.)
Do the virgin/waste materials storage areas Q Q Q Q
have a berm and sump drain to contain spills
and leaks?
If your storage area does not have a berm, do Q Q Q Q
you use a self-contained spills management
method, such as pallets that have built-in spill
containment?
Have you sealed all floor drains in areas that Q Q Q Q
are used for the storage of hazardous
materials (when practical) or made other
preparations for containment?
Does the health care facility store all Q Q Q Q
hazardous materials and empty containers
separate from nonhazardous materials and
containers?
Ethylene Oxide (EtO)
Ethylene oxide or a mixture of EtO and chlorofluorocarbon (CFC) is used to sterilize medical
devices. Ethylene oxide is a probable human carcinogen, as well as being flammable and explosive.
In addition, chlorofluorocarbon (CFC) is an ozone depleting chemical.
Yes No Not Can't
Applicable Determine
Are OSHA regulations and manufacturers Q Q Q Q
recommendations for ethylene oxide being
followed?
Is the ethylene oxide equipment inspected Q Q Q Q
regularly including checking the seal on the
sterilizer doors and maintained according to
manufacturers' recommendations?
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 11 February 2000
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Is the ethylene oxide equipment and air
quality in the room tested regularly for
possible leaks?
Has the health care facility investigated the
utilization of other sterilization methods?
(Some possible alternatives include:
radiation, vapor-phase hydrogen peroxide,
steam, ozone and microwave radiation.)
Does the health care facility have an EtO spill
cleanup policy?
Have the employees been properly trained in
the use of EtO sterilization equipment and
handling of EtO cylinders and cartridges?
Yes
a
a
No
a
a
Can't
Determine
a
a
Not
Applicable
a
a
a a
a a
a
a
a
a
Glutaraldehyde
Glutaraldehyde is primarily used in the cold sterilization of surgical, medical and dental equipment.
It is also used in embalming, electron and light microscopy as a tissue fixative and in x-ray film
processing solutions as a fixative.
Yes
Have the employees who work with
glutaraldehyde been trained in its hazards,
safe use, proper handling, spill cleanup
procedures and waste reporting practices?
No
a
Not
Applicable
a
Can't
Determine
a
Is emergency response equipment suitable for Q Q Q
glutaraldehyde incidents available nearby?
Are the containers storing glutaraldehyde kept Q Q Q
closed when not in use?
Is glutaraldehyde stored in appropriate Q Q Q
containers which are in good condition?
Are glutaraldehyde containers always checked Q Q Q
for leaks and damage before moving or
manipulating?
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
12
A Checklist for Pollution Prevention
February 2000
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Yes No Can't Not
Determine Applicable
Is appropriate first aid equipment (i.e., eye Q Q Q Q
wash) available in the areas were
glutaraldehyde is being used?
Are the employees handling glutaraldehyde Q Q Q Q
provided with personal protective equipment?
Is appropriate first aid equipment (i.e., eye Q Q Q Q
wash) available in the areas where
glutaraldehyde is being used?
Is air monitoring being performed to prevent Q Q Q Q
worker exposure to glutaraldehyde?
Are the areas where glutaraldehyde is being Q Q Q Q
used and stored equipped with proper
ventilation systems?
Are glutaraldehyde solutions being used in Q Q Q Q
accordance with manufacturer's directions?
Are employees instructed to use only the Q Q Q Q
smallest amount necessary of glutaraldehyde
solution?
Has the health care facility investigated the Q Q Q Q
utilization of other sterilization methods?
PVC (polyvinyl chloride) Plastics
Concerns about the health impact from the incineration of disposable chlorinated products, due to
the potential formation and release ofdioxin to the environment, has prompted the USEPA to issue
guidelines to control hospital medical and infectious waste air emissions.
Products that may contain PVC plastic include:
IV bags and tubing Patient ID bracelets
endotracheal tubes Compression sleeves
oxygen tents Thermal blankets
vinyl gloves Resuscitation bags
catheters Blood bags
basins Packaging
Mattress covers Bedpans
Catheters Inflatable splints
The use of alternatives products, an effective waste segregation program and pollution prevention
strategies can help eliminate this discharge.
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 13 February 2000
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Has the health care facility developed and
implemented a PVC free purchasing policy?
Have all of the products which contain PVC
plastic been identified?
Have PVC products been replaced by non-
PVC products where possible?
Have alternatives to PVC plastics products
been explored?
Has the health care facility considered
switching from vinyl gloves to nitrile gloves?
Does your health care facility recycle unused
PVC plastic apparatus? (i.e., washbins, water
pitchers, cups, etc.)
Are sharps containers PVC-free (i.e.,
polyethylene or reusable)?
If not, have these alternatives been
considered?
;s
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No
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Not
Applicable
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Can't
Determine
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Solvents
Health care facilities typically generate solvents in a variety of their daily functions, including
pathology, histology, maintenance, embalming and laboratories. Many of these solvents may be
classified as hazardous waste, and therefore are required to be properly treated and/or disposed.
Pollution prevention strategies can be used to eliminate solvent use by using nontoxic alternatives,
or to reduce both the toxicity and the quantity of spent solvents.
Yes
Has the use of aqueous reagents, simple Q
alcohols and ketones (instead of petroleum
hydrocarbons) and sonic or steam cleaning
been considered to replace solvent-based
cleaning?
Are different solvent waste streams Q
segregated so that they can be recycled?
Are waste solvents being recycled off-site? Q
No Not
Applicable
a a
a a
a a
Can't
Determine
a
a
a
Environmental Self-Assessment
For Health Care Facilities
14
A Checklist for Pollution Prevention
February 2000
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Has the use of an on-site distillation unit to
recover waste solvents been considered?
(Contact the NYSDEC for distillation unit
regulatory information. Also, the quality and
effectiveness of the recovered solvent should
be evaluated before purchasing a distillation
unit.)
If different solvents are used for cleaning,
can they be replaced with a multipurpose
solvent that can be used for a variety of
applications?
Have you investigated nontoxic alternatives
to replace solvents, where possible?
Have you considered switching to less-toxic
and less-flammable solvents?
Has the use of premixed containerized kits
for tests involving solvent fixation been
explored?
Have you investigated alternatives to using
xylene in histology?
Have you considered using calibrated solvent
dispensers for routine tests?
If solvents are utilized for cleaning, is it
possible to reuse used solvent for initial
cleaning of other areas and fresh solvent only
for final cleaning?
Yes
a
No
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Can't
Determine
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Not
Applicable
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Environmental Self-Assessment
For Health Care Facilities
15
A Checklist for Pollution Prevention
February 2000
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Mercury
Mercury is bioaccumulative and persists in the environment. It is toxic to humans in all forms
(organic and inorganic). The inappropriate disposal of mercury can cause it to be released to the
air, water or land from wastewater discharges, spills, landfilling and incineration. The release of
mercury to the environment can be reduced by using alternatives to medical devices containing
mercury, cleaning up spills properly, recycling mercury containing products and properly handling
and disposing of mercury containing equipment. See Appendix A for medical products and
equipment that may contain mercury.
Does the health care facility have a Mercury
Management Program?
Does the health care facility have a
purchasing policy which includes a
commitment to purchase mercury-free
products whenever possible?
Is the health care facility working towards
eliminating mercury waste generation by the
year 2005 as outlined in the Memorandum of
Understanding—Voluntary Partnership
between the American Hospital Association
and the Environmental Protection Agency?
(More information on this partnership can be
found on http://www.epa.gov/grtlakes/
toxteam/ahamou.htm )
Have equipment and supplies that contain
mercury been identified? (See Appendix A
for a listing of potential mercury sources.)
Have laboratory chemicals been identified
that may contain mercury? (See Appendix A
for a listing of potential mercury sources.)
Are mercury-free laboratory reagents being
used that will achieve the same diagnostic
results?
Has the health care facility stopped sending
mercury containing thermometers home with
new mothers?
Are mercury thermometers being phased out
through the use of electronic sensors or
temperature strips?
Yes
a
a
No
a
a
Not
Applicable
a
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
16
A Checklist for Pollution Prevention
February 2000
-------
Is mercury-containing equipment, such as
thermometers and blood pressure
instruments, being replaced with mercury-
free alternatives? (Possible alternatives for
thermometers and blood pressure
instruments include digital or disposable
strips and electronic vacuum gauge,
expansion or aneroid, respectively.)
Does the health care facility completely drain
and recycle all residual mercury from
thermometers, blood pressure reservoirs, and
other medical devices prior to discarding the
equipment?
Have you replaced mercury containing
esophageal dilators (bougie tubes), cantor
tubes, feeding tubes and Miller Abbott tubes
with mercury-free alternatives?
Are mercury vacuum apparatus (with the
proper mercury vapor controls) and spill
absorbent kits readily available to clean up
mercury spills? (Residue from mercury
cleanups must be properly disposed or
recycled.)
Have employees been trained in the hazards
of mercury, spill cleanup and the proper
handling and reporting of mercury waste?
Have employees been trained on the correct
procedures for segregating mercury waste?
Are cantor tubes from the operating rooms
and surgical units being disposed of properly
by personnel?
If mercury still exists in your hospital, is
there a regular inspection of sewer traps and
catch basins to prevent release of mercury to
the environment?
Yes
a
No
a
Can't
Determine
a
Not
Applicable
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
17
A Checklist for Pollution Prevention
February 2000
-------
Chemotherapy & Antineoplastic Chemicals
Chemotherapy and antineoplastic chemical waste can be generated during drug preparation, drug
administration and spills.
Yes
Are the procedures outlined in OSHA
Instruction PUB 8-1.1, January 28, 1986,
Guidelines for Cytotoxic (Antineoplastic)
Drugs being followed?
Are unopened, surplus, obsolete or outdated
drugs returned to the manufacturer? (Note:
Returning some medical supplies may be
prohibited if the material is a hazardous
waste and destined for disposal instead of
evaluation/recycling by the manufacturer.
Please contact the NYSDEC, Division of
Solid and Hazardous Materials for further
guidance.)
Are separate distinctively labeled containers
available to keep chemotherapy wastes apart
from other waste streams?
Are chemotherapy wastes placed into a
leakproof, rigid container and kept
segregated from other wastes?
Are drug containers purchased in amounts
that minimize the amount of out-of-date
material?
Are drugs purchased in container sizes that
permit formulation of daily dosages with the
least quantity of excess product leftover?
Can chemotherapy compounding stations be
centralized to improve management of
chemotherapy waste?
Are appropriate personnel trained to
transport and handle chemotherapy waste in
a safe manner to prevent exposure?
Are chemotherapy drugs prepared under a
biological safety hood?
No
a
Not
Applicable
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Can't
Determine
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
18
A Checklist for Pollution Prevention
February 2000
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Have employees been trained in
chemotherapy drug handling, safety, waste
minimization and, spill containment and
cleanup procedures?
Are spill cleanup kits available in the
compounding area that contain both small
and large absorbent devices?
Yes
a
No
a
Not
Applicable
a
Can't
Determine
a
a
a
a
a
Batteries
Batteries are used in a number of medical devices, such as defibrillators, hearing aids, fetal
monitors, pagers, temperature alarm, blood analyzer, spirometer alarm, telemetry transmitter,
hofler monitor and pacemakers. The batteries used in a health care facility can include: alkaline,
mercuric oxide (mercury zinc), lead acid, lithium, zinc air button batteries, silver oxide button
batteries and rechargeable nickel-cadmium. The inappropriate disposal of batteries may result in
toxic releases occurring from medical waste incinerator emissions or landfill leachate.
Yes
Does the health care facility have written
procedures regarding the proper management
of used batteries?
Do employees receive training on the health
care facility's procedures for proper
management of used batteries?
Has the health care facility determined which
types of used batteries are hazardous waste?
(A battery is a hazardous waste if it exhibits
one or more of the characteristics defined in
section 371.3 of 6NYCRRPart 371,
Identification and Listing of Hazardous
Wastes. Some used batteries are likely to be
classified as hazardous waste due to the
various amounts of heavy metals such as lead,
mercury and cadmium that they contain.)
Are used batteries that are determined to be a
hazardous waste handled in accordance with
6NYCRR Subpart 374-3 Standards for
Universal Wastes? (Assistance with
applicable regulatory requirements should be
directed to your Regional NYSDEC office.)
a
a
No
a
a
a
Not
Applicable
a
a
a
Can't
Determine
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
19
A Checklist for Pollution Prevention
February 2000
-------
Yes No Not Can't
Applicable Determine
Is it determined before purchasing batteries, Q Q Q
which ones contain the lowest levels of heavy
metals? (Possible alternatives include lithium,
zinc-air, silver-oxide and alkaline.)
Are all batteries inventoried and tracked? Q Q Q
Does the health care facility use rechargeable Q Q Q
alkaline and nickel-cadmium batteries? (A
hazardous waste determination must be made
on spent rechargeable batteries if they are no
longer rechargeable and will be discarded.)
Has the health care facility implemented a Q Q Q
battery collection program? (Batteries that
are determined to be hazardous must be
managed in accordance with 6NYCRR
Subpart 374-3 Standards for Universal
Wastes. However, the collection program
should take in all batteries. The hazardous
waste manager can then sort through the
batteries to determine appropriate waste
management options. The NYSDEC,
Division of Solid and Hazardous Materials,
Bureau of Waste Reduction & Recycling at
(518) 457-7337 maintains a list of battery
recyclers.)
Are employees trained in the proper Q Q Q
management and segregation of used
batteries?
Are employees required to exchange a spent Q Q Q
battery in order to receive a new battery?
Note: For medical devices, there are Food and Drug Administration and Underwriters
Laboratory certification concerns with replacing a battery. Please contact the
equipment manufacturer before replacing a battery with a substitute to ensure that the
device has been approved for use with the alternative battery.
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 20 February 2000
-------
Lamps
Many lamps frequently contain mercury and sometimes lead, principally because of the use of lead
solder. Various lamps used in a health care facility include fluorescent, mercury vapor, high
pressure sodium vapor, incandescent, high intensity discharge, metal halide, cathode ray tubes and
ultraviolet. Mercury is a toxic, bioaccumlative pollutant; therefore, the proper management of spent
mercury-containing lamps is essential for minimizing mercury releases. Management controls
include safe handling to prevent breakage and keeping hazardous waste lamps from being disposed
of in landfills and incinerators.
Yes
Have all of the various types of lamps used at
the health care facility been identified? (These
can include, but are not limited to,
fluorescent, mercury vapor, high pressure
sodium vapor, metal halide, incandescent,
high intensity discharge and neon lamps.)
Has the health care facility determined which
types of spent lamps are hazardous waste? (A
spent lamp is a hazardous waste if it exhibits
one or more of the characteristics defined in
section 371.3 of 6NYCRRPart 371
Identification and Listing of Hazardous
Wastes. Many fluorescent, mercury vapor,
high intensity discharge and other lamps
frequently contain mercury, and sometimes
lead, principally because of the use of lead
solder.)
Are there several convenient collection points
for spent lamps throughout the health care
facility? (Spent lamps from the collection
points should be taken to a secure area for
sorting and to prevent accidental breakage.)
Are spent lamps being collected for
recycling? (Contact the NYSDEC-Division
of Solid and Hazardous Materials, Bureau of
Waste Reduction & Recycling at (518) 457-
7337 for a list of recyclers.)
Are employees trained in the proper
management and safety procedures for
reporting and responding to broken or
nonworking lamps?
No
a
Not
Applicable
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
21
A Checklist for Pollution Prevention
February 2000
-------
Yes
Are spent lamps that are determined to be a
hazardous waste being handled in accordance
with the Standards for Universal Wastes?
(On July 6, 1999, the USEPA issued a final
rule for inclusion of hazardous waste lamps in
the Universal Waste Rule of 40 CFR Part
273. New York State has established a policy
of enforcement discretion, effective January
6, 2000, with regard to the management of
hazardous waste lamps as universal waste.
This enforcement discretion policy will
remain in effect until New York adopts the
provisions of 40 CFR Part 273, for lamps,
into6NYCRRSubpart374-3. Broken or
crushed lamps determined to be hazardous
cannot be handled as Universal Wastes and
must be handled in accordance with
applicable hazardous waste regulations.
Assistance with applicable regulatory
requirements can be directed to the NYSDEC
Division of Solid and Hazardous Materials.)
Are new as well as waste lamps being stored
to prevent breakage?
Are broken lamps separated, placed in a
heavy plastic bag and put inside a sturdy
container for disposal?
Has the health care facility developed a plan
to phase out mercury-containing lamps?
Can lighting systems be upgraded to be more
efficient? (The New York State Energy
Research and Development Authority
(NYSERDA) works with businesses,
institutions, and municipalities to provide
energy engineering and technical assistance.
In addition, the Environmental Protection
Agency's Green Lights program promotes
energy efficiency in buildings. Participants
are provided with unbiased technical
information, customized support services,
public relations assistance, and access to a
broad range of resources and tools.)
No
a
Can't
Determine
a
Not
Applicable
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
22
A Checklist for Pollution Prevention
February 2000
-------
Photographic Chemicals and Scrap Film
The radiology department may generate wastewater containing photographic chemicals and silver
from film processing, scrap film, fixer solution and outdated chemicals.
Yes
Are all employees whose jobs involve
contact with photographic chemicals and
scrap film trained in the safety and the
appropriate handling and disposal of these
substances?
Do you store photographic chemicals
correctly to prolong their shelf life? (Some
photographic chemicals are light and
temperature sensitive.)
Are lead foil film packets sent to a recycler?
Are damaged and used x-ray films sent to a
recycler?
Is the silver from x-ray fixture solution
recovered by an on-site silver recovery unit?
If not, is the fixture solution collected and
sent off-site for recycling?
In nonautomated processing systems, is a
squeegee used to wipe excess liquid from the
film? (This procedure helps minimize the
chemical contamination of baths and
increases bath life.)
Is countercurrent washing used in
photographic processors to reduce
wastewater generation?
Are materials that have an expired shelf life
tested for effectiveness prior to being
disposed of or returned? (Note: Returning
some medical supplies may be prohibited if
the material is a hazardous waste and
destined for disposal instead of
evaluation/recycling by the manufacturer.
Please contact the NYSDEC, Division of
Solid and Hazardous Materials for further
guidance.)
No
a
Not
Applicable
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
23
A Checklist for Pollution Prevention
February 2000
-------
Are the usefulness of the solutions in the
photographic processing baths being
extended by the following methods?
- adding ammonium thiosulfate
- using acid stop bath prior to fixing
- adding acetic acid to fixing bath to keep pH
low
- Keeping baths in covered, airtight
containers to reduce evaporation and
oxidation
Do you require that all photographic
containers be clearly labeled with their
contents?
Yes No Can't Not
Determine Applicable
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Formaldehyde/formalin
Formaldehyde is used in embalming, autopsy, dialysis (formalin), specimen preservation and
pathology.
Have all areas been identified where
formaldehyde/formalin is being used?
Have you standardized formalin cleaning
solutions in order to use the minimum
strength required?
Are proper air emission controls being used?
Have you considered automating the
dispensing of formalin to reduce excess
amounts generated?
Do you collect waste formaldehyde and
formalin for proper disposal?
Has the use of reverse osmosis waste
treatment to reduce the dialysis cleaning
demands with formaldehyde been explored?
Has the reuse of formaldehyde in pathology
and autopsy labs been explored?
Yes
a
a
a
a
a
a
a
No
a
a
a
a
a
a
a
Not
Applicable
a
a
a
a
a
a
a
Can't
Determine
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
24
A Checklist for Pollution Prevention
February 2000
-------
Radioactive Waste
In health care facilities, radioactive material is used in conducting in-vitro and in-vivo biomedical
research work, clinical laboratory studies, and medical diagnostic and therapeutic procedures
performed on patients. The types of radioactive waste that may be generated include solids, liquids,
animal carcasses, or equipment contaminated with short-lived or long-lived radionuclides. Every
health care facility that uses radionuclides may only do so in accordance with the authorization
granted under its radioactive material license. The license requires that all resultant radioactive
waste be properly managed and that waste minimization procedures be practiced. The health care
facility's radiation safety officer is the person listed on the radioactive materials license who is
responsible for ensuring that radioactive materials and wastes are properly managed, and that any
disposal or discharge of radioactive materials to the environment is conducted in accordance with
the 6 NYCRR Part 3 80 regulations issued by the NYS Department of Environmental Conservation.
Any questions regarding the Part 380 regulations should be directed to the Department's Radiation
Section at (518) 457-2225.
Yes
Is radioactive waste managed in accordance
with the facility's waste minimization plan, as
required by the radioactive materials license?
Are all radioactive waste generating
procedures periodically evaluated to ensure
that radioactive waste is not created
unnecessarily?
Is radioactive waste disposed of by any of the
following methods, in accordance with
Section 380-4?
Is radioactive waste disposed of by any of the
following methods, in accordance with
Section 380-4?
- Returned to vendor
- Decayed in storage
- Released to the municipal sanitary sewer
system
- Under the biomedical exemption
- Another method as authorized in a Part 380
permit
- Shipped to a licensed disposal facility
a
a
a
a
a
a
a
a
No
a
a
Not
Applicable
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Can't
Determine
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
25
A Checklist for Pollution Prevention
February 2000
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Medical Waste Stream
Segregating nonregulated medical waste from regulated medical waste, at the point of generation,
can significantly reduce the impact it has on the environment. Regulated medical waste should
always be kept separate from hazardous, radioactive and chemotherapy wastes, whenever possible,
to avoid mixtures that are difficult to treat and properly dispose of. In addition, the incineration of
regulated medical waste should be limited to those waste streams requiring incineration as a
treatment technology. Alternative technologies that are more environmentally friendly should be
used for all other regulated medical waste streams. (Regulated medical waste is defined in Public
Health Law 1389M<3G,)
Has the health care facility established
written standards for handling and disposing
of regulated medical waste?
Have all appropriate health care facility
employees received training on proper waste
stream characterization and segregation?
Are employee's made aware of the reasons
and need for segregating wastes properly?
Are training programs provided to all
appropriate staff on the proper management
and safety procedures for handling and
disposing of radioactive waste, hazardous
waste (including chemotherapy), hospital
waste and regulated medical waste streams?
Has a comprehensive survey been conducted
at the health care facility to determine the
location of waste containers, the items
deposited in each bag or container and the
waste liner color? (Overuse of red bags may
be taking place in some areas.)
Is the health care facility staff separating
waste streams into the correct waste stream
categories?
Are regulated medical wastes that contain
hazardous or radioactive wastes segregated
from nonhazardous and nonradioactive
regulated medical wastes for proper
disposal?
Yes
a
a
a
a
No
a
a
a
a
Not
Applicable
a
a
a
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
26
A Checklist for Pollution Prevention
February 2000
-------
Is the regulated medical waste stream further
separated into "sharps" and "nonsharps"
waste to accommodate the proper treatment,
recycling and disposal destinations?
Are human pathological wastes and sharps,
in the regulated medical waste stream,
further segregated to accommodate proper
treatment and disposal destinations?
Whenever possible is regulated medical
waste stored separate from hazardous or
radioactive waste?
Is regulated medical waste properly
containerized as close as is practical to the
point of generation?
Has a modification of the regulated medical
waste container layout at the facility been
considered to reduce the volume of red bag
waste resulting from the improper
segregation of wastes?
Have clear bag-receptacles been provided in
appropriate areas to prevent the disposal of
nonregulated medical waste into regulated
medical waste red bags?
Have you renegotiated contracts with
regulated medical waste haulers to provide
decontaminated, clean reusable containers?
(Reusable containers should not be used for
any other purpose).
Do you use cadmium-free red bags?
(Cadmium is used as a colorant in some red
bags that can then be released during
incineration.)
Are waste containers clearly marked and
easily accessible to facilitate proper waste
segregation?
Are soiled, broken or rusted waste
receptacles replaced on a regular basis?
Yes
a
a
a
a
a
a
a
a
a
a
No
a
a
a
a
a
a
a
a
a
a
Not
Applicable
a
a
a
a
a
a
a
a
a
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
27
A Checklist for Pollution Prevention
February 2000
-------
Yes
Has the health care facility considered
reducing the volume of infectious waste by
placing alternative receptacles in the
operating rooms? (Receptacles can be used
to collect, under sterile conditions, the
plastic packaging material that is used to seal
the surgery supplies and instruments. These
receptacles can then be closed and isolated
from the main area to eliminate the risk of
contamination from infectious/medical
waste.)
Are soiled, broken or rusted waste
receptacles replaced on a regular basis?
Are the appropriate size receptacles being
used for the volume of waste generated?
Are regulated medical waste containers
properly sealed and labeled before they are
moved to another location at the health care
facility for storage, treatment or disposal?
Is there a designated biohazard waste storage
area clearly labeled with the word biohazard
or the universal biohazard symbol!
Is the biohazard waste storage area securely
controlled with access limited to authorized
personnel?
Does the storage area have proper ventilation
and mechanical controls (i.e., refrigeration)
to maintain waste in a nonputrescent state?
Is liquid biohazard waste discharged to a
sanitary sewer in compliance with applicable
state and/or local regulations?
Is the biohazard waste storage area protected
from the weather to ensure that the storage
containers remain intact?
Is the biohazard waste storage area
maintained in a sanitary condition, free of
rodents and insects and secure from
vandalism?
No
a
Not
Applicable
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
28
A Checklist for Pollution Prevention
February 2000
-------
Recycling and Reuse
Reuse and recycling programs can significantly reduce the amount of waste that your health care
facility has to ship off-site for disposal, in addition to conserving our natural resources and
eliminating the generation of hazardous waste that would otherwise result during manufacturing.
Does the health care facility have a
purchasing policy that requires postconsumer
recycled content products be purchased when
available?
Has the health care facility replaced
disposable supplies with reusable products,
when the safety and health of patients and
staff are not compromised? (Some reusable
products to consider include: utensils and
plates, sharp containers, rechargeable
batteries, sterilization trays, bed pans, emesis
basins, cloth gowns and drapes, slippers,
male urinal basins, packaging totes,
biohazard containers, recharged toner
cartridges, bedpans, diapers and underpads).
Does the health care facility use reusable
decubitus mattresses to eliminate the need
for disposable egg-crate pads?
Does the health care facility currently have
recycling programs in place for the
administrative offices, waiting rooms and
cafeterias? (Some of the items which can be
considered for recycling programs include:
office paper, newspaper, books, magazines,
aluminum, bottles, glass, plastics, corrugated
cardboard, junk mail. Contact the NYSDEC,
Division of Solid and Hazardous Materials
to find out how to start a recycling program
at your facility.)
Has the possibility of sending unused
medical equipment overseas been explored?
(Items suitable for donation can include
syringes, gauze, gowns, sponges, operating
room tables, wheelchairs and stretchers.)
Yes
a
No
a
Not
Applicable
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
29
A Checklist for Pollution Prevention
February 2000
-------
Housekeeping
Yes No Not Can't
Applicable Determine
Are housekeeping employees trained in the Q Q Q
proper management and safety procedures
for radioactive waste, hazardous waste
(including chemotheraphy), hospital waste,
regulated medical waste and cleaning
chemicals?
Have employees been trained in spill Q Q Q
containment and cleanup procedures?
Are employees aware of the health care Q Q Q
facility's recycling programs?
Can multiple brands of cleaning compounds Q Q Q
be replaced by a few detergents whose
disinfecting strength is adjusted by the
housekeeping staff?
Has the health care facility considered Q Q Q
limiting the variety of housekeeping
solutions used? (i.e., Implementing a
metering dispensing system for dispensing
fewer chemicals in the proper amount and
concentration.)
Have less toxic cleaning products been Q Q Q
identified and used?
Have alternatives to cleaning chemicals and Q Q Q
degreasers that contain mercury been
explored? (To ascertain the mercury content
of materials being used, request a copy of the
Certificates of Analysis from all suppliers.
Certificates of Analysis should list the
mercury content in parts per billion (ppb),
not as a percentage.)
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 3 0 February 2000
-------
Facility Maintenance
Yes
Are mercury thermostats, covered under the
requirements of 6 NYCRR Subpart 374-3
Standards for Universal Wastes, being
managed in accordance with these
regulations? (Assistance with applicable
regulatory requirements should be directed to
the NYSDEC Division of Solid and
Hazardous Materials.)
Are pesticides, covered under the
requirements of 6 NYCRR Subpart 374-3
Standards for Universal Wastes, being
managed in accordance with these
regulations? (Assistance with applicable
regulatory requirements should be directed to
the NYSDEC Division of Solid and
Hazardous Materials.)
Has the health care facility developed and
implemented an integrated pesticide
management plan that reduces to the greatest
extent possible the use of chemical
pesticides?
Is it possible to reduce the amount of
pesticide applications and/or use
nonchemical pest control methods?
If the health care facility generates used oil,
are they in compliance with 6 NYCRR
Subpart 374-2 Standards for the
Management of Used Oil!
Does the maintenance department collect
and recycle waste cleaning solvents?
Has an on-site solvent distillation system
been considered as a way to recycle waste
solvent? (Check with your local NYSDEC
office regarding regulations that apply to
distillation systems.)
Are vendors required to take back pallets
and/or packaging material?
No
a
Not
Applicable
a
Can't
Determine
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
31
A Checklist for Pollution Prevention
February 2000
-------
Yes
Are the concrete floors of the maintenance Q
areas sealed with an impervious material to
facilitate cleanup without using solvents?
Are maintenance areas cleaned with a Q
biodegradable detergent?
Are your employees required to wipe up Q
small spills as soon as they occur?
Do maintenance personnel use dry methods Q
for clean-up of small spills?
Are maintenance personnel required to pick Q
up absorbent material as soon as possible
after the leak or spill has been immobilized?
Has the maintenance department considered Q
using water-based paints?
Are waste towels being stored in a closed, Q
metal safety container?
Are instruments and products which contain Q
mercury being collected and properly
managed? (See Appendix A for additional
maintenance equipment that may contain
mercury).
Does your maintenance department send its Q
dirty shop towels to a commercial laundry
service for cleaning?
No
Can't
Determine
a
a
a
a
a
a
a
a
Not
Applicable
a
a
a
a
a
a
a
a
a
a
Environmental Self-Assessment
For Health Care Facilities
32
A Checklist for Pollution Prevention
February 2000
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P2 Pays
The University of Rochester's Strong Memorial Hospital implemented an effective mercury
reduction program in which mercury-containing equipment was substituted with electronic and
mercury-free equipment, and mercury compounds were eliminated from certain activities
within the clinical labs.
Mercury thermometer usage was the primary target of the mercury reduction program. Even
though Strong Memorial Hospital performed approximately 750,000 temperature readings per
year using electronic thermometers, there were still areas or situations where significant usage
of mercury thermometers existed. These situations were evaluated and mercury thermometers
were replaced wherever possible with electronic thermometers. During the course of the
implementation, there were other opportunities to replace mercury containing items with
mercury-free equipment. For example, mercury-filled sphygmomanometers were replaced
with aneroid sphygmomanometers during the course of new construction, renovation, or as
existing equipment was replaced. Also, mercury-filled gastrointestinal tubing was replaced
with tungsten-filled tubing. Existing staff educational programs were upgraded to include
mercury specific facts and handling procedures. In addition, the nursing policy was revised to
discourage the practice of allowing patients to take mercury thermometers home with them.
Other mercury reduction initiatives included the elimination of mercury compounds within the
clinical labs whenever there is an alternative. Histopathology discontinued the use of mercury
compounds in 1992. The same was also true for the installation of energy efficient lighting
and the management of mercury-containing fluorescent lamps.
In addition to the economic benefit to Strong Memorial Hospital as a result of the mercury
reduction program, the real driver, in their opinion, was the win-win situation afforded by
being mercury-free. All of the problems associated with using and disposing of a hazardous
material were eliminated by replacement with nonhazardous materials.
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 33 February 2000
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NEXT STEPS
Following the completion of the self-assessment, you should be left with a list of operational
areas where there are opportunities for pollution prevention. The next step is to obtain additional
information to allow you to explore these opportunities and to determine which are cost effective and
technically feasible without reducing service quality. A good first step is to consult the publications
listed in the references section (see page 46). You should also check with vendors and request
information about hospital supplies and medical equipment that are more "environmentally friendly."
Other sources of information regarding pollution prevention are the trade organizations and local,
state and federal programs listed in "A Resource Guide," page 35.
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 34 February 2000
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RESOURCE GUIDE
The following organizations provide technical assistance, publish information, conduct
workshops and conferences; and provide telephone and on-site information on pollution prevention
and better management of medical waste, air, water, solid and hazardous waste issues.
Trade Organizations
Joint Commission on Accreditation of
Healthcare Organizations (JCAHO)
One Renaissance Boulevard
Oakbrook Terrace, IL 60181
Phone: (630) 792-5000
Fax: (630) 792-5005
Internet: http://www.j caho.org
Greater New York Hospital Association
(GNYHA)
555 West 57th Street, 15th Floor
New York, New York 10019
Phone: (212)246-7100
Fax: (212)262-6350
Internet: http://www.gnyha.org
American Hospital Association (AHA) -
Chicago Headquarters
One North Franklin
Chicago, IL 60606
Phone:(312)422-3000
Fax:(312)422-4796
Internet: http://www.aha.org
Healthcare Association of New York State
(HANYS)
74 North Pearl Street
Albany, New York 12207
Phone:(518)431-7600
Fax:(518)431-7915
Internet: http ://www.hanys. org
New York State Nurses Association (NYSNA) Western New York Healthcare Association
11 Cornell Road
Latham, New York 12110-1499
Phone:(518)782-9400
Fax: (518)782-9530
E-mail: infor@nysna.org
Internet: http://www.nysna.org
North Metropolitan Hospital Association
400 Stony Brook Court
Newburgh, NY 12250-5162
Phone: (914) 562-7520
Fax: (914)562-0187
Internet: http://www.normet.org
1876 Niagara Falls Blvd.
Tonawanda, NY 14150
Phone:(716) 695-0843
Fax:(716) 695-0073
E-mail: wnyha@wnyha.com
Internet: http://www.wnyha.com
Lowell Center for Sustainable Production
Sustainable Hospitals Project
Kitson Hall, Room 2000
One University Avenue
Lowell, MA 01854
Phone: (978) 934-3259
E-mail: lcsp@uml.edu
Internet:
http://www.uml.edu/centers/LCSP/hospitals/
Environmental Self-Assessment
For Health Care Facilities
35
A Checklist for Pollution Prevention
February 2000
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Iroquois Healthcare Organization
Clifton Park Office
17 Halfmoon Executive Park Drive
Clifton Park, NY 12065
Phone: (518)383-5060
Fax: (518)383-2616
Syracuse Office
5740 Commons Park
East Syracuse, NY 13057-9400
Phone: (315)445-1851
Fax: (315)445-2293
Internet: http://www.iroquois.org
Health Care Without Harm
National contact: Health Care Without Harm
c/o Center for Health, Environment and Justice
P.O. Box 6808
Falls Church, VA 22040
Phone: (703) 237-2249
Fax: (703)237-8389
E-mail: noharm@iatp.org
Internet: http://www.noharm.org
NYS Nurses Association
11 Cornell Road
Latham, NY 12110
Phone: (518)782-9400
Fax: (518)782-9530
E-mail: info@nysna.org
Internet: http://www.nysna.org
Physicians for Social Responsibility/NYC
475 Riverside Drive #551
New York, NY 10115
Phone: (212) 890-2980
Fax: (212) 890-2243
E-mail: psrnyc@igc.apc.org
Internet: http://www.psr.org.index.html
Medical Society of the State of New York
(MSSNY)
MSSNY Office
420 Lakeville Road, P.O. Box 5404
Lake Success, NY 11042-5404
Phone:(516)488-6100
Fax:(516)488-1267
E-mail: mssny@mssny.org
Albany Office
1 Commerce Plaza
99 Washington Avenue, Suite 2103
Albany, NY 12210
Phone:(518)465-8085
Fax:(518)465-0976
E-mail: mssnyalb@ix.netcom.com
Internet: http://www.mssny.org
Health Care Without Harm
New York State contact:
Citizens' Environmental Coalition
33 Central Avenue
Albany, NY 12210
Phone:(518)462-5527
Fax:(518)465-8349
E-mail: cechcwh@juno.com
New York Committee on Occupational
Safety & Health (NYCOSH)
275 7th Avenue
New York, NY 10001
Phone: (212) 627-3900
E-mail: nycosh@nycosh.org
Internet: http://www.nycosh.org
Environmental Self-Assessment
For Health Care Facilities
36
A Checklist for Pollution Prevention
February 2000
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Local Assistance
NEW YORK STATE:
University at Buffalo
Center for Integrated Waste Management
Jarvis Hall, Room 207
Buffalo, NY 14260-4400
Phone: (716) 645-3446, Ext. 2340
FAX: (716) 645-3667
METROPOLITAN AREA:
NYC Dept. of Environmental Protection
Environmental Economic Development
Assistance Unit
59-17 Junction Boulevard, 11th Floor
Corona, NY 11368-5107
Phone: (718)595-4462
FAX: (718) 595-4479
MONROE COUNTY:
Monroe County Department of
Environmental Services
444 East Henrietta Road, Bldg, #15
Rochester, NY 14620
Phone: (716) 760-7523
FAX: (716) 324-1213
ONONDAGA COUNTY:
Onondaga County Resources Recovery
Agency
100 Elwood Davis Road
North Syracuse, NY 13212
Phone: (315)453-2866
FAX: (315) 453-2872
Hotline #: (315) 453-2870
BROOME COUNTY:
Broome County
Division of Solid Waste Management
Edwin L. Crawford County Office Building
P.O. Box 1766
44 Hawley Street
Binghamton, NY13902
Phone: (607) 778-2250
FAX: (607) 778-2395
ERIE COUNTY:
Erie County Department
of Environment & Planning
Office of Pollution Prevention
95 Franklin Street, Room 1077
Buffalo, NY 14202-3973
Phone: (716) 858-7583
FAX: (716) 858-7713
CHAUTAUOUA. CATTARAUGUS AND
ALLEGANY COUNTIES:
The Southwestern New York
Environmental Compliance Network
Jamestown Community College
525 Falconer Street, P.O. Box 20
Jamestown, NY 14702-0020
Phone: (716) 665-5220 ext. 446
FAX: (716) 665-2585
The Center for Business and Industry
SUNY at Fredonia
Lograsso Hall
Fredonia, NY 14063
Phone: (716)673-3177
FAX: (716) 673-3175
Environmental Self-Assessment
For Health Care Facilities
37
A Checklist for Pollution Prevention
February 2000
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New York State Department of Environmental Conservation
Pollution Prevention Unit
Phone: (518)457-2553
Small Quantity Generator P2 Hotline
(800)462-6553, Out of State: (518)485-8471
This technical assistance unit provides P2
information, develops industry sector
manuals and other publications, offers
workshops/training, holds annual pollution
prevention conferences, coordinates NYS
Governor's P2 Awards, and prepares annual
toxic release inventory (TRI) reports.
Division of Solid and Hazardous Materials
Bureau of Hazardous Waste Management
(518)485-8988
This bureau is responsible for making
hazardous waste determinations, for
reviewing hazardous waste reduction plans,
hazardous waste permitting, and for
hazardous waste compliance.
Bureau of Waste Reduction & Recycling
(518)457-7337
This bureau is responsible for the waste tire
program, the beneficial use program, the
composting program, and other solid waste
recycling and waste reduction issues.
Bureau of Solid Waste & Land Management
(518)457-1859
This bureau administers the Part 360
Program, performs enforcement and
monitoring, and conducts regulatory
compliance inspections for landfills, waste-
to-energy facilities, transfer stations and
regulated medial waste facilities. Provides
information on transporting and/or disposal
of regulated medical waste as well as
regulated medical waste generated in non-
Article 28 and non-Part 58 facilities.
Division of Water
Bureau of Water Facilities Design
(518)457-1157
Responsible for managing the State Pollutant
Discharge Elimination System (SPDES)
permits, the SPDES program for storm water
discharges, the water resources programs,
and the municipal water supply permits.
Division of Environmental Remediation
Bureau of Spill Prevention and Response
(518)457-9412
This office is responsible for the registration
of tanks, presenting workshops and training,
developing publications, receiving spill
notifications, and serves as an information
clearinghouse for industries and the public.
Spill Response Hotline
(800) 457-7362
To report releases of petroleum products or
hazardous substances to air, land or water in
New York State. Regulations require
reporting within 2 hours if certain conditions
are not met. Also, the National Response
Center should be notified (see listing on page
41).
Petroleum Bulk Storage Hotline
(888)457-4351
Provides technical assistance on chemical
and petroleum aboveground and
underground storage tanks.
Environmental Self-Assessment
For Health Care Facilities
38
A Checklist for Pollution Prevention
February 2000
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Division of Environmental Permits
Phone: (518)457-2224
This office is responsible for issuing
permits to waste haulers that transport
solid and hazardous, industrial &
commercial, sewage andseptage waste.
Division of Air Resources
Bureau of Stationary Sources
(518)457-7688
This bureau is responsible for source review,
permitting, MACT, NASHAP implementation,
and air toxics assessments.
NYSDEC - Regional Offices
REGION 1
Nassau & Suffolk Counties
SUNY Campus
Loop Road, Building 40
Stony Brook, NY 11790-2356
Phone: (516)444-0354
REGION 2
Bronx, Kings, New York, Queens &
Richmond Counties
1 Hunters Point Plaza
47-40 21st Street
Long Island City, NY 11101-5407
Phone:(718)482-4900
REGION 3
Dutchess, Orange, Putnam, Rockland,
Sullivan, Ulster & Westchester Counties
21 South Putt Corners Road
New Paltz, NY 12561-1696
Phone:(914)256-3000
REGION 4
Albany, Columbia, Delaware, Greene,
Montgomery, Otsego, Rensselaer,
Schenectady & Schoharie Counties
HSOWestcottRoad
Schenectady, NY 12306-2014
Phone:(518)357-2234
REGION 5
Clinton, Essex, Franklin, Fulton, Hamilton,
Saratoga, Warren & Washington Counties
Route 86, PO Box 296
Ray Brook, NY 12977-0296
Phone:(518)897-1200
REGION 6
Herkimer, Jefferson, Lewis,
Oneida & St. Lawrence Counties
State Office Building
317 Washington Street
Watertown, NY 13601
Phone:(315)785-2238
REGION 7
Broome, Cayuga, Chenango, Cortland,
Madison, Onondaga, Oswego,
Tioga & Tompkins Counties
615 Erie Blvd. W.
Syracuse, NY 13204-2400
Phone:(315)426-7400
REGION 8
Chemung, Genesee, Livingston, Monroe,
Ontario, Orleans, Schuyler, Seneca,
Steuben, Wayne & Yates Counties
6274 East Avon-Lima Road
Avon, NY 14414
Phone:(716)226-2466
REGION 9
Allegany, Cattaraugus, Chautauqua,
Erie, Niagara, & Wyoming Counties
270 Michigan Ave.
Buffalo, NY 14203-2999
Phone:(716)851-7000
Environmental Self-Assessment
For Health Care Facilities
39
A Checklist for Pollution Prevention
February 2000
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Other State Agencies
Empire State Development (BSD),
Small Business Division,
Clean Air Act Small Business Ombudsman
633 3rd Avenue, 32nd Floor
New York, NY 10017
Phone: (800) STATENY
For assistance in determining how
regulations may affect a business and in
communicating with state regulatory
agencies; sets up workshops; and handles
complaints.
NYS Department of Health
Corning Tower
Empire State Plaza
Albany, NewYork 12237
Phone:(518)485-5378
For questions concerning the management
of regulated medical waste as it pertains to
the Public Health Law 1389 AA-GG.
NYS Environmental Facilities Corporation
Small Business Assistance Program
50 Wolf Road, Albany, NY 12205
Hotline: (800) 780-7227
Phone:(518)457-9135
FAX: (518)485-8494
Provides fee-free technical assistance, interprets
requirements, provides advice on pollution
prevention and control strategies and conducts
environmental audits. EFC also provides
fee-based contractual technical advisory
services for a broad range of environmental
issues.
NYS Department of Health
Wadsworth Center -
Regulated Medical Waste Program
Phone:(518)485-5378
Provides a list of approved treatment
technologies and information on the application
procedures to obtain approval for alternative
treatment systems, as well as questions related
to efficacy test methods and results.
Federal Assistance
Pollution Prevention Information
Clearinghouse
Phone: (202)260-1023
Fax: (202) 260-9780
E-mail:ppic@epamail.epa.gov
Provides a library and an electronic
bulletin board dedicated to information on
pollution prevention.
U.S. EPA Region II
Compliance Assistance & Program
Support Branch
290 Broadway, 22nd Floor
New York, NY 10007-1866
Phone: (212) 637-3268
To receive technical assistance and
guidance on compliance, pollution
prevention and waste minimization issues
on a multimedia basis.
U.S. EPA Asbestos and Small Business
Ombudsman Hotline
Phone: (800)368-5888
Helps private citizens, small businesses and
smaller communities with questions on all
program aspects with EPA.
National Response Center
Phone: (800)424-8802
EPA's 24-hour hotline for reporting oil and
chemical spills to the Federal Government. This
hotline is manned by the U.S. Coast Guard.
RCRA/Superfund/EPCRA Hotline
Phone: (800)424-9346
To obtain information on matters related to
solid waste, hazardous waste, or underground
storage tanks. Also can be used to order EPA
publications.
Environmental Self-Assessment
For Health Care Facilities
40
A Checklist for Pollution Prevention
February 2000
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Internet Resources
Organization
Joint Commission on Accreditation of Healthcare
Organizations
American Hospital Association
Greater New York Hospital Association
Healthcare Association of New York State, Inc.
Iroquois Healthcare Alliance
Medical Society of the State of New York
Northern Metropolitan Hospital Association
Western New York Healthcare Association
World Health Organization
Health Care Without Harm
Centers for Disease Control and Protection
U.S. Department of Veterans Affairs
New York State Nurses Association
Tellus Institute
North Carolina's Division of Pollution
Prevention and Environmental Assistance
NEW YORK STATE
Empire State Development Services to Business
NYS Department of Environmental Conservation
NYS Environmental Facilities Corporation
NYS Energy Research and Development
Authority
U.S. EPA
Green Lights Partnership
Enviro$en$e
Technology Transfer Network
Climate Wise
U.S. DEPARTMENT OF ENERGY
Pollution Prevention Information Clearinghouse
Internet Address
http://www.jcaho.org
http://www.aha.org
http://www.gnyha.org
http://www.hanys.org
http://www.iroquois.org
http://www.mssny.org
http ://www.normet. org
http ://www. wnyha. com
http://www.who.int
http ://www. noharm. org
http://www.cdc.gov
http://va.gov
http://www.nysna.org
http ://www.tellus. org
http://www.p2pays.org
http://www.empire.state.ny.us
http://www.dec.state.ny.us
http ://www.nysefc. org
http ://www.nyserda. org
http://www.epa.gov/greenlights.html
http://www.es.epa.gov
http://www.epa.gov/ttnsbapl/index.html
http://www.ega.gov/climatewise
http: //epi c. er. doe. gov/epi c
Environmental Self-Assessment
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41
A Checklist for Pollution Prevention
February 2000
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PACIFIC NORTHWESTLABORA TORIES
Green Guide http://www.pnl.gov
Pollution Prevention Resource Center http://www.pprc.org
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 42 February 2000
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Appendix A
Health Care Facilities Instruments And
Products That May Contain Mercury
The following information was obtained from: Reducing Mercury Use in Health Care, Promoting
a Healthier Environment, A How-to Manual, prepared by Monroe County Department of Health,
in cooperation with Strong Memorial Hospital, Rochester, NY and the Monroe County Department
of Environmental Services, with funding by a grant from the U.S. Environmental Protection Agency.
This list should not be assumed to be complete.
Thermometers
Body temperature thermometers
Clerget sugar test thermometers
Heating and cooling system thermometers
Incubator/water bath thermometers
Minimum/Maximum thermometers
National Institute of Standards and Technology calibration thermometers
Tapered bulb (armored) thermometers
Sphygmomanometers
Gastrointestinal tubes
Cantor tubes
Esophageal dilators (bougie tubes)
Feeding tubes
Miller Abbott tubes
Dental amalgam
Pharmaceutical supplies
Contact lens solutions and other opthalmic products containing thimerosal
phenylmercuric acetate or phenlymercuric nitrate
Diuretics with mersalyl and mercury salts
Early pregnancy test kits with mercury containing preservatives
Merbromin/water solution
Nasal spray with thimerosal, phenylmercuric acetate or phenylmercuris nitrate
Vaccines with thimerosal (primiarily in hemophilus, hepatitis, rabies, tetanus, influenza,
diphtheris and pertussis vaccines)
Cleaners and degreasers with mercury-contaminated caustic soda or chlorine
Batteries (medical uses)
Alarms
Blood analyzers
Defibrillators
Hearing aids
Meters
Monitors
Pacemakers
Pumps
Scales
Telemetry transmitters
Ultrasound
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 43 February 2000
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Appendix A - Continued
Health Care Facilities Instruments And
Products That May Contain Mercury
Ventilators
Batteries (nonmedical uses)
Lamps
Fluorescent
Germicidal
High-intensity discharge (high pressure sodium, mercury vapor, metal halide)
Ultraviolet
Electrical equipment
Tilt switches
Air flow/fan limit control
Building security systems
Chest freezer lids
Fire alarm box switches
Lap-top computer screen shut-off
Pressure control (mounted on bourbon tube or diaphragm)
Silent light switches (single-pole and three-way)
Temperature control (mounted on bimetal coil or attached to bulb devices)
Washing machine (power shut off)
Float control
Septic tanks
Sump pumps
Thermostats (nondigital)
Thermostat probes in electrical equipment
Reed relays (low voltage, high precision analytical equipment)
Plunger or displacement relays (high current/high voltage application)
Thermostat probes in gas appliances (flame sensors, gas safety valves)
Pressure gauges
Barometers
Manometers
Vacuum gauges
Other
Devices, such as personal computers, that utilize a printed wire board
Blood gas analyzer reference electrode (Radiometer brand)
Cathode-ray oscilloscope
DC watt hour meters (Duncan)
Electron microscope (mercury may be used as a damper)
Flow meters
Generators
Hitachi Chem Analyzer reagent
Lead analyzer electrode (ESA model 301 OB)
Sequential Multi-Channel Autoanalyzer (SMCA) AU 2000
Vibration meters
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 44 February 2000
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Appendix B
Alternative Treatment Technologies
The following information was obtained from: New York State Department of Health
(NYSDOH), Managing Regulated Medical Waste, Interpretive Guidelines for Implementing
Revisions to Public Health Law 1389AA-GG.
There are numerous alternative technologies which are currently available from over forty
manufactures within the United States and Europe. They vary in capacity from those designed
for use in physician/dentist offices, capable of treating twenty-five to one hundred pounds per
cycle, to systems to be used in major medical centers or regional treatment facilities, which are
able to treat one ton or more of waste per cycle (generally a cycle is one to one and one/half
hours in length). In many instances these alternative technologies simultaneously treat, destroy,
and reduce the volume of regulated medical waste through the use of pre- or post-treatment
grinders/shredders orby the use of extremely high temperatures (upwards of 15,000 °F) to reduce
the waste to ash. They vary in cost from less than $2,000 per unit to approximately $750,000
per system. The larger the capacity, the greater the waste reduction and the more automated the
technology, the higher the initial cost of the unit. However, regardless of the capacity, the extent
of the automation, or overall volume reduction, all alternative systems treat regulated medical
waste using one of three methods; (a) heating the waste to a minimum of 210 °F by means of
microwaves, radio waves, hot oil, hot water, steam or superheated gases; (b) exposing the waste
to chemicals such as sodium hypochlorite (household bleach) or chlorine dioxide; or (c) by
subjecting the waste to heated chemicals.
All alternative technologies must be approved by the NYS Department of Health prior to being
offered for sale in New York State. The Regulated Medical Waste Program (RMWP) is the unit
within the Wadsworth Center which evaluates all alternative treatment systems for the
Department of Health. Each manufacturer seeking approval of an alternative treatment system
for use in the State must test the efficacy of the product in accordance with the recommendations
contained in the Technical Assistance Manual: State Regulatory Oversight of Medical Waste
Treatment Technologies. A list of such approved treatment technologies and information on the
application procedures to obtain approval for alternative systems, as well as questions related to
efficacy test results can be obtained by calling the Regulated Medical Waste Program at (518)
485-5378.
It is important to understand that a form that evidences treatment by an approved technology
must accompany the treated waste to a solid waste management facility authorized to accept the
treated regulated medical waste. The Department of Health has developed a form for this
purpose which must be used by those facilities that treat on-site by incineration or autoclaving.
The Department of Health does not require the use of this specific form with waste treated by
some alternative treatment technologies.
Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 45 February 2000
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U.S. Environmental Protection Agency (June, 1990). Guides to Pollution Prevention: Selected
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North Carolina Department of Environment, Health, and Natural Resources (August, 1996).
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Tickner, Joel, Lowell Center for Sustainable Production, University of Massachusetts Lowell
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Environmental Self-Assessment A Checklist for Pollution Prevention
For Health Care Facilities 47 February 2000
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United States
Environmental Protection
Agency
Solid Waste and
Emergency Response
(5305W)
EPA530-K-02-022I
October 2001
»EPA
RCRA, Superfund & EPCRA
Call Center Training Module
Introduction to:
Solid and Hazardous Waste
Exclusions
(40CFR§261.4)
Updated October 2001
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DISCLAIMER
This document was developed by Booz Allen Hamilton Inc. under contract 68-W-01-020 to EPA.
It is intended to be used as a training tool for Call Center specialists and does not represent a
statement of EPA policy.
The information in this document is not by any means a complete representation of EPA s
regulations or policies. This document is used only in the capacity of the Call Center training and
is not used as a reference tool on Call Center calls. The Call Center revises and updates this
document as regulatory program areas change.
The information in this document may not necessarily reflect the current position of the Agency.
This document is not intended and cannot be relied upon to create any rights, substantive or
procedural, enforceable by any party in litigation with the United States.
RCRA, Superfund & EPCRA Call Center Phone Numbers:
National toll-free (outside of DC area) (800) 424-9346
Local number (within DC area) (703) 412-9810
National toll-free for the hearing impaired (TDD) (800) 553-7672
The Call Center is open from 9 am to 5 pm Eastern Time,
Monday through Friday, except for federal holidays.
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SOLID AND HAZARDOUS WASTE EXCLUSIONS
CONTENTS
1. Introduction 1
2. Regulatory Summary 2
2.1 Solid Waste Exclusions 2
2.2 Hazardous Waste Exclusions 11
2.3 Exclusions for Raw Material, Product and Process Unit Wastes 20
2.4 Sample and Treatability Study Exclusions 21
2.5 Dredged Material Exclusion 22
3. Special Issues 23
3.1 Federally Owned Treatment Works 23
3.2 Household Hazardous Waste Collection Programs 23
3.3 Municipal Waste Combustion Ash 23
4. Regulatory Developments 24
4.1 Deferral from RCRA for the Management and Disposal of Lead Based
Paint Debris 24
4.2 Petroleum-Contaminated Media and Debris from Non-USTs 24
4.3 Glass Frit and Fluoride-Rich Baghouse Dust Generated by the Vitrification
ofK088 25
4.4 Zinc Fertilizers Made From Recycled Hazardous Secondary Materials 25
4.5 Project XL Site-Specific Exclusion 25
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Solid and Hazardous Waste Exclusions - 1
1. INTRODUCTION
The Resource Conservation and Recovery Act's (RCRA) Subtitle C hazardous waste
management program is a comprehensive and carefully constructed system to
ensure wastes are managed safely and lawfully. This program begins with a specific,
formal process to categorize wastes accurately and appropriately. This process is
called waste identification. Because of the risks posed by mishandled hazardous
wastes and the cost of hazardous waste management, this hazardous waste
identification process is critical to operating the hazardous waste program
effectively.
Some of the materials that would otherwise fit the definitions of a solid or
hazardous waste under waste identification are specifically excluded from the
definitions. EPA concluded that these materials should not be regulated as solid or
hazardous wastes for one or more of a number of reasons. Many exclusions are
mandated in the statute. EPA selected other exclusions to provide an incentive to
recycle certain materials, because there was not enough information on the material
to justify its regulation as a solid or hazardous waste, or because the material was
already subject to regulation under another statute. The exclusions from the
definition of a RCRA solid or hazardous waste are codified in 40 CFR §261.4.
This module explains each waste exclusion and its scope, so you can apply this
knowledge in determining whether a given waste is or is not regulated under
RCRA Subtitle C. When you have completed this module, you will be able to:
• Cite the regulatory section for exclusions, and identify materials that are not
solid wastes and solid wastes that are not hazardous wastes
• Locate the manufacturing process unit exclusion
• Identify the sample and treatability study exclusions and their applicability
• Outline and specify the conditions for meeting the exclusions for household
wastes and mixtures of domestic sewage.
Use this list of objectives to check your knowledge of this topic after you complete
the training session.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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2 - Solid and Hazardous Waste Exclusions
2. REGULATORY SUMMARY
After determining that a waste is a solid waste, the next step in every hazardous
waste determination requires the generator to determine if the waste fits any of the
six categories of exclusions identified in §261.4 (§262.11 (a)). If the waste fits one of
these categories, it is not regulated as a RCRA hazardous waste, and the hazardous
waste determination process ceases. The first category includes wastes that are
excluded from being solid wastes (§261.4(a)). The second category covers wastes that
are excluded from being hazardous wastes (§261.4(b)). The remaining four categories
are conditional exclusions that only apply when the provisions established under
each section are met. Section 261.4(c) contains an exclusion for hazardous waste
generated in raw material, product storage, or manufacturing units. Section 261.4(d)
provides an exclusion for laboratory samples and the §§261.4(e) and (f) exclusions
apply to waste treatability studies. Finally, §261.4(g) excludes dredged material from
the definition of hazardous waste when permitted under the Marine Protection
Research and Sanctuaries Act (MPRSA), or the Clean Water Act (CWA). If a waste is
excluded under any of these categories, Subtitle C hazardous waste requirements do
not apply. On the other hand, if an exclusion does not apply, the steps of hazardous
waste identification continue pursuant to §262.11.
These five broad categories of §261.4 exclusions are addressed in the order in which
they appear in the CFR.
2.1 SOLID WASTE EXCLUSIONS
The exclusions from the definition of solid waste are listed in §261.4(a). If a material
is listed under §261.4(a), it is not a solid waste and thus, under the regulations,
cannot be a hazardous waste. The analysis of the waste stops there if it is excluded
— it does not matter if the material exhibits a characteristic as set out in §§261.21
through 261.24 (i.e., ignitable, corrosive, reactive, or toxic), or would otherwise be a
waste listed in Part 261, Subpart D. Currently there are 19 exclusions under §261.4(a).
These materials are excluded for a variety of reasons, including public policy,
economic impacts, regulation by other laws, lack of data, or impracticability of
regulating the waste. The decision to exclude the following materials from the solid
waste definition is a result of either Congressional action (embodied in the statute)
or EPA rulemaking.
DOMESTIC SEWAGE AND MIXTURES OF DOMESTIC SEWAGE (§261.4(a)(l))
Sanitary wastes that pass through a publicly or privately owned sewer system are
considered domestic sewage and are excluded from regulation under Subtitle C (45
FR 33066, 33097; May 19, 1980).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 3
Under §261.4(a)(l)(ii), mixtures of sanitary wastes and other wastes (including
hazardous industrial wastes) that pass through a sewer system to a publicly owned
treatment works (POTW) are excluded from Subtitle C regulation. The exclusion
applies to a waste when it first enters a sewer system provided that it will mix with
sanitary wastes prior to storage or treatment by a POTW. The Agency interprets this
exclusion to begin at the point of entry into the sewage system, not at the point the
hazardous waste actually mixes with the sewage (45 FR 33066, 33097; May 19, 1980).
This exclusion does not include any waste directly transported to the POTW by truck
or rail shipments (45 FR 33066, 33097 and 33176; May 19, 1980).
Prior to entering the sewer system, the waste may be a solid and a hazardous waste
subject to RCRA regulation during generation, storage, and treatment. Once the
waste has been discharged to the POTW, it is subject to CWA regulations and local
restrictions. Note that CWA may prohibit discharges of certain chemicals and
wastes into a sewer system. Because wastes that mix with domestic sewage are not
considered solid wastes, the POTW would not be deemed to be receiving or treating
RCRA hazardous wastes. However, sludge generated at the POTW from the
treatment of the waste is subject to §262.11 analysis because it is a new point of
generation. If the newly-generated waste exhibits a characteristic of hazardous waste
(i.e., ignitability, corrosivity, reactivity, or toxicity), it would be subject to Subtitle C
regulation (45 FR 33066, 33101; May 19, 1980).
In certain circumstances, this exclusion may be applied to domestic sewage and
mixtures of domestic sewage that pass through a federally owned treatment works
(FOTW).
POINT SOURCE DISCHARGE (§261.4(a)(2))
Industrial wastewater discharges that are subject to CWA §402, also called point
source discharges, are excluded from Subtitle C regulation. Point source discharges
are "discernible or discrete conveyances" from which pollutants may be discharged,
such as a pipe. CWA regulates such discharges under the National Pollutant
Discharge Elimination System (NPDES) permitting program. To avoid duplicative
regulation, this exclusion applies at the discharge point where the wastes are first
subject to CWA regulation (45 FR 33066, 33098; May 19, 1980). Any hazardous waste
generation, treatment, or storage prior to the point source discharge is subject to
RCRA. Many industrial facilities that treat wastewater on site, and then discharge it,
use this point source discharge exclusion.
IRRIGATION RETURN FLOW (§261.4(a)(3))
When agricultural land is irrigated, excess water may return to the water basin either as
surface water runoff or through groundwater percolation. Though these return flows
may often carry hazardous constituents (from pesticides or fertilizers) or exhibit a
characteristic of hazardous waste, these wastes are excluded under §261.4(a)(3) (45 FR
33066, 33098; May 19, 1980).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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4 - Solid and Hazardous Waste Exclusions
RADIOACTIVE WASTE (§261.4(a)(4))
To avoid duplicative regulation of some materials under both RCRA and the
Atomic Energy Act (AEA), there is an exclusion from RCRA for radioactive wastes
(i.e., source, special nuclear, or by-product materials) that are regulated under AEA
(45 FR 33066, 33098; May 19, 1980). However, if non-radioactive components of the
waste make the waste a RCRA hazardous waste, then the waste is regulated by both
AEA and RCRA. EPA regulates the hazardous waste portion through RCRA, while
the Nuclear Regulatory Commission and the Department of Energy regulate the
radioactive portion under the AEA.
IN-SITU MINING (§261.4(a)(5))
In-situ mining of oil shale, uranium, and other minerals may involve the
application of solvent solutions directly to a mineral deposit in the ground. The
solvent passes through the ground, collecting the mineral as it moves. The mineral
and solvent mixtures are then collected in underground wells where the solution is
removed. The solvent-contaminated earth produced, or the solution not recovered,
by the in-situ mining process is not subject to RCRA when left in place (45 FR 33066,
33101; May 19, 1980).
PULPING LIQUORS (§261.4(a)(6))
Pulping liquor is a corrosive material used to dissolve wood chips. Pulping liquors,
also called black liquors, that are reclaimed in a pulping liquor recovery furnace and
then reused in the pulping process are excluded, unless accumulated speculatively
as defined in §261.1(c) or reclaimed in another manner (50 FR 614, 642; January 4,
1985).
SPENT SULFURIC ACID (§261.4(a)(7))
Spent sulfuric acid is typically used to produce virgin sulfuric acid by reintroduction
into the sulfuric acid production process. Spent sulfuric acid that is recycled in this
manner is excluded from the definition of solid waste, unless accumulated
speculatively as defined in §261.l(c) (50 FR 614, 642; January 4, 1985).
RECLAMATION IN ENCLOSED TANKS (§261.4(a)(8))
The exclusion in §261.4(a)(8), known as the closed-loop recycling exclusion, covers
secondary materials (e.g., spent materials or sludges) generated during production
processes which are reusable in those same processes (51 FR 25422, 25441; July 14,
1986). These secondary materials, if reclaimed and returned to the original
process(es), are excluded, provided:
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 5
• Only tank storage is involved and the entire process, through the completion
of reclamation, is closed
• Reclamation does not involve incineration or other controlled-flame
combustion (i.e., boilers or furnaces)
• Secondary materials are never accumulated in tanks for more than 12
months without being reclaimed
• Reclaimed materials are not used to produce a fuel, or used to produce
products that are used in a manner constituting disposal.
SPENT WOOD PRESERVATIVES (§261.4(a)(9))
Spent wood preservatives are typically collected and reclaimed through a series of
drip pads connected integrally to the production process, closely resembling a closed-
loop scenario. Since the use of drip pads will not allow this reclamation process to
fit the closed-loop exclusion in §261.4 (a) (8), EPA developed an exclusion in
§261.4(a)(9) for reclaimed spent wood preserving solutions and wastewaters
containing spent preservative that are reused for their original purpose (55 FR
50450, 50460; December 6, 1990).
Spent wood preserving solutions and wastewaters containing spent preservative are
excluded at the point they are generated (prior to reclamation or direct reuse in the
wood preserving operations), provided certain conditions are met. To qualify for
this exclusion, these materials must be recycled and reused on site for their original
intended purpose, and must be managed to prevent releases to land and
groundwater. Additionally, the drip pads that collect wood preserving solutions
must meet Subtitle C design and operating requirements (63 FR 28556, 28627; May
26, 1998). Finally, a plant owner must notify EPA of an intent to claim that the
wastes are exempt from regulation.
COKE BY-PRODUCT WASTES (§261.4(a)(10))
Certain coke by-product wastes are excluded from the definition of solid waste. Coke,
a product used in the production of iron, is manufactured by carbonizing coal in
high temperature coke ovens. Throughout the production process many by-
products are created. The initial by-product in the production process is coke oven
gas (COG), which is refined to create products such as coal tar, light oil, and sodium
phenolate. The coal tar is then further refined into pitch, naphthalene, refined tar,
bitumen, and creosote oil. The refinement of these coke by-products generates
several listed and characteristic wastestreams.
EPA granted an exclusion for K087, K141, K142, K143, K144, K145, K147, K148 and
any other coke by-product wastes which exhibit the toxicity characteristic, when
recycled in the following manner:
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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6 - Solid and Hazardous Waste Exclusions
• Returned to the coke oven as a feedstock to produce coke; or
• Returned to the tar recovery process as a feedstock to produce coal tar; or
• Mixed with coal tar prior to coal tar refining or sale as a product.
In addition, to qualify for the exclusion, the coke by-product waste cannot be placed
on the land from the time it is generated to the point it is recycled. EPA based its
decision to exclude coke by-product wastes on the fact that recycling these wastes did
not have a significant effect on the chemical composition of the products. Further,
coke by-product residues are often managed as raw materials rather than wastes,
thereby reducing the risk posed to human health and the environment because the
material has an intrinsic value that promotes its safe management.
SPLASH CONDENSER DROSS RESIDUE (§261.4(a)(ll))
The treatment of emission control dust/sludge from the primary production of steel
in electric furnaces (K061) generates a zinc-laden dross residue from the splash
condenser in a high temperature metal recovery (HTMR) process. This residue,
known as splash condenser dross residue (SCDR), is typically considered a partially
reclaimed secondary material because it contains 50 to 60 percent zinc. SCDR is
commonly sent off site for further reclamation, reused on site in the HTMR process,
or reprocessed by the HTMR on site.
EPA determined that the SCDR material generated by certain HTMR processes does
not pose a significant threat to human health and the environment as managed
currently and therefore excluded it from Subtitle C regulation. The exclusion
applies when the material is used as a source of zinc in zinc recovery operations,
provided it is shipped in drums (if sent off site) and not disposed of on the land at
any point prior to further recovery (56 FR 41164; August 19, 1991).
HAZARDOUS SECONDARY MATERIALS FROM THE PETROLEUM REFINING
INDUSTRY (§261.4(a)(12))
Hazardous Secondary Materials Generated and Recycled Within Petroleum
Refineries (§261.4(a)(12)(i))
Many hazardous sludges, by-products, and spent materials are generated throughout
the petroleum refining process. Often these secondary materials can be recycled back
into the refining process to recover their oil content. Under the current regulatory
definition of solid waste, secondary materials which are recycled in certain ways are
excluded from the definition of solid waste (e.g., characteristic sludges which are
being reclaimed) (§261.2). However, secondary materials that are used to produce
fuels meet the definition of solid waste (§261.2(e)(2)(ii)). Thus, any hazardous
secondary materials generated and recycled within the petroleum refining industry
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 7
would have to be managed under Subtitle C, since petroleum is, by definition, a
fuel.
In order to promote recycling of these materials, EPA promulgated an exclusion for
oil-bearing secondary materials that are generated and recycled by the petroleum
refining industry (SIC code 2911). This exclusion applies to any oil-bearing material
generated at a petroleum refinery, including oil-bearing wastes commonly regulated
as listed hazardous wastes (i.e., F037, F038, K048-K052, K169-K170), when these
materials are reinserted into the petroleum refining process, including the coke
quenching process (63 FR 42110; August 6, 1998).
This exclusion is limited to secondary materials generated during refining
operations and does not extend to wastes generated elsewhere within the petroleum
refining industry, such as from petroleum exploration and production sites, bulk
crude oil storage, and petroleum industry-related transportation facilities. The
secondary materials can be recycled in an on-site refining process or can be sent
directly to an off-site petroleum refining facility to be reinserted back into the
refining process, including, but not limited to, distillation, catalytic cracking,
fractionation, or thermal cracking units (i.e., cokers). However, secondary materials
that are inserted into a petroleum coker only qualify for this exclusion if the
resulting coke product does not exhibit a characteristic of hazardous waste. Finally,
all secondary materials that are excluded from the definition of solid waste under
this exclusion cannot be placed on the land prior to recycling and cannot be
speculatively accumulated.
Any residues generated from the recycling of oil-bearing hazardous secondary
material, which otherwise would have met another listing description, are
considered F037 listed wastes if intended for, or sent for, disposal (63 FR 42110;
August 6, 1998).
Recovered Oil (§261.4(a)(12)(ii))
In addition to the exclusion for secondary materials generated by and recycled
within petroleum refineries, oil recovered from secondary materials with
significant oil content that are generated within the petroleum industry (i.e., not
just form refineries), may be excluded from the definition of solid waste as
recovered oil.
Recovered oil is a generic term that refers to materials that are primarily oil and that
are recovered from secondary materials generated during any phase of petroleum
exploration, production, refining, and related transportation. This includes
oil/water separator skimmings from plant wastewaters, slop oil and emulsions, oil
skimmed from ballast water tanks, and oil from refinery process units (59 FR 38536;
July 28, 1994). Recovered oil does not include listed oil-bearing hazardous wastes
(i.e., F037, F038, K048-K052, and K169-K172). In summary, §261.4(a) (12) (i) excludes
oil-bearing secondary materials generated at a petroleum refinery and recycled back
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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8 - Solid and Hazardous Waste Exclusions
into a refinery while §261.4(a)(12)(ii) excludes "oil" from the larger universe of the
petroleum industry (e.g., refining, exploration and production, transportation
related thereto) when the oil is inserted into a petroleum refinery. Used oil, as
defined in §279.1, does not qualify as recovered oil.
EXCLUDED SCRAP METAL (§261.4(a)(13))
Processed scrap metal, unprocessed home scrap metal, and unprocessed prompt
scrap metal being recycled (collectively referred to as excluded scrap metal) are all
excluded from the definition of solid waste and therefore not subject to RCRA
Subtitle C regulations. EPA believes that excluded scrap metal being recycled is
distinct from other secondary materials defined as wastes when recycled due to
established markets for the material's use, inherent positive economic value of the
material, the physical form of the material, and the absence of damage incidents
attributed to the material. The Agency believes that these characteristics combined
indicate that the above types of scrap metal are sufficiently product-like, making
RCRA jurisdiction over these materials unnecessary.
Processed scrap metal is scrap metal that has been manually or mechanically altered
to either separate it into distinct materials to enhance economic value or to improve
the handling of materials. Processed scrap metal includes, but is not limited to,
scrap metal which has been bailed, shredded, sheared, chopped, crushed, flattened,
cut, melted, or separated by metal type; and fines, drosses and related materials
which have been agglomerated. Home scrap is scrap metal generated by steel mills,
foundries, and refineries, and also includes turnings, cuttings, punchings, and
borings. Prompt scrap, also known as industrial or new scrap metal, is generated by
the metal working/fabrication industries and includes scrap such as turnings,
cuttings, punchings, and borings (62 FR 25998; 26011; May 12, 1997).
Prior to this exclusion, scrap metal being reclaimed was a solid waste, but was
exempt from RCRA Subtitle C regulations. Scrap metal that does not meet the
conditions of the §261.4(a)(13) exclusion (i.e., all other scrap metal) is considered a
solid waste but continues to be exempt from substantive Subtitle C regulation if
being reclaimed (§261.6(a) (3) (ii)).
SHREDDED CIRCUITS BOARDS (§261.4.(a)(14))
Shredded circuit boards being recycled are excluded from the definition of solid
waste, provided they are stored in containers sufficient to prevent a release to the
environment, and are free of mercury switches, mercury relays, nickel-cadmium
batteries, and lithium batteries. "Free of these materials" means mercury switches
or relays, or cadmium or lithium batteries are not or have not been part of the
shredded circuit board batch. Shredded circuit boards that are not free of these
materials are solid wastes (spent materials) when reclaimed.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 9
Shredded circuit boards are not considered scrap metal, because the process of
shredding the boards produces small fines from the whole board which are
dispersible and do not meet the RCRA regulatory definition of scrap metal.
However, shredded circuit boards can be considered secondary feedstocks, analogous
to raw materials, if they have demonstrated positive economic value and they are
managed in a way that reduces environmental risk (62 FR 25998, 26011-26012; May
12, 1997). Because shredding is a common industry practice and is beneficial to the
recovery process, the Agency found this exclusion to be justified.
Whole circuit boards can meet the definition of scrap metal provided they are free of
mercury switches, mercury relays, lithium batteries, or nickel-cadmium batteries, or
have minimal quantities of mercury and batteries and are protectively packaged to
minimize dispersion of metal constituents (63 FR 28556, 28630; May 26, 1998). As
scrap metal, these whole circuit boards are exempt from regulation when recycled
PULPING CONDENSATES DERIVED FROM KRAFT MILL STEAM STRIPPERS
(§261.4(a)(15))
The kraft pulping process is the most commonly used pulping process today. It
utilizes various chemicals to break down wood into pulp. One of the options for
controlling emissions from kraft pulping process condensates is to remove the
hazardous air pollutants, primarily methanol, from the condensates using an air
pollution control device called a stripper. After the hazardous pollutants are
removed, a vent gas remains. Many mills then concentrate this vent gas by
condensing, and subsequently burning, the liquid methanol as fuel.
The condensed methanol may be ignitable, and therefore would subject the facilities
that burn this fuel to RCRA. EPA believes that this particular management practice
reduces secondary environmental impacts, and provides cost savings for the mills.
Consequently, the Agency promulgated an exclusion from the definition of solid
waste for condensates derived from kraft mill steam strippers. This exclusion
applies only if the waste is combusted at the mill that generated the condensates (63
FR 18533; April 15, 1998).
COMPARABLE FUELS (§261.4(a)(16))
Hazardous waste-derived fuels that are comparable to fossil fuels are excluded from
the definition of solid waste. These exempted fuels have legitimate energy value
and hazardous constituent concentrations similar to fossil fuels. Consequently, EPA
has classified such fuels as products, rather than wastes. The exclusion promotes
RCRA's resource recovery goals without creating a risk greater than that posed by
commonly used commercial fuels. Only liquid and gaseous hazardous waste-
derived fuels qualify for this exclusion.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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10 - Solid and Hazardous Waste Exclusions
In addition, the generator of the comparable fuel is required to comply with
sampling and analysis requirements to demonstrate that the fuel is indeed
comparable to fossil fuels. EPA sets standards, or specifications, for the level of Part
261, Appendix VIII hazardous constituents contained in the comparable fuel, the
flash point, the heating value, and the viscosity of the waste-derived fuel (§261.38).
The generator must also certify that the fuel is comparable, notify EPA and the
public that a fuel will be burned on site, and maintain records at the facility about
the fuel (63 FR 33782, 33783; June 19, 1998).
MINERAL PROCESSING SECONDARY MATERIALS BEING RECYCLED
(§261.4(a)(17))
Mining and the recovery of mineral value from ores and minerals are processes that
generate many wastes. These wastes fall into three general categories: extraction,
beneficiation, and mineral-processing. All extraction and beneficiation wastes and
20 specific mineral-processing wastes are completely exempt from Subtitle C
regulation (§261.4(b)(7)). However, other mineral-processing wastes are potentially
regulated as hazardous wastes, if they exhibit a characteristic.
The Phase IV Land Disposal Restrictions (LDR) rule, issued on May 26, 1998,
excluded from the definition of solid waste any secondary mineral-processing
materials being reclaimed within the mineral-processing industry, provided the
materials are not stored on land prior to reclamation (§261.4(a) (17)). While the
Phase IV rule generally relaxed jurisdiction over spent materials being reclaimed
within the mineral-processing industry, as long as no land-based storage preceded
reclamation, it asserted jurisdiction over some previously unregulated secondary
materials (i.e., characteristic by-products and characteristic sludges), if they were
stored on land prior to reclamation.
The Association of Battery Recyclers, the National Mining Association and other
metals-related trade groups challenged the Phase IV rule in the D.C. Circuit Court.
On April 21, 2000, the D.C. Circuit issued a decision (Association of Battery Recyclers
v. EPA No. 98-1368) vacating the portion of the LDR Phase IV rule that asserted
jurisdiction over characteristic by-products and sludges from the mineral-processing
industry that are stored on the land prior to recycling. At this time the Agency has
not issued any guidance on the impact of the decision.
PETROCHEMICAL RECOVERED OIL (§261.4(a)(18))
On August 6, 1998, EPA finalized an exclusion for recovered oil, generated at certain
organic chemical industry facilities, which is inserted into the petroleum refining
process provided certain conditions are met (63 FR 42110). The term "petrochemical
recovered oil" includes materials, which are primarily oil, and which are generated
at organic chemical industry operations. Only petrochemical recovered oil that is
hazardous because it exhibits the characteristic of ignitability or exhibits the toxicity
characteristic for benzene (or both) is eligible for this exclusion. Additionally, EPA
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 11
has clarified that this exclusion applies exclusively to recovered oil from "associated
organic chemical manufacturing facilities." Therefore, only organic chemical
manufacturing facilities (primary SIC code of 2869), which are adjacent to a refinery,
or whose operations are closely integrated with a petroleum refinery, are eligible for
this exclusion. Examples of highly integrated facilities might include instances
where a chemical manufacturing facility and refinery share a common wastewater
treatment system; share manufacturing units; or have environmental permits that
cover both facilities. Similar to the recovered oil exclusion from petroleum
production (§261.4(a)(12)(ii)), petrochemical recovered oil can be inserted into the
petroleum refinery process with normal petroleum refinery wastestreams. Finally,
in order to qualify for this exclusion, the petrochemical recovered must not be
speculatively accumulated or placed on the land prior to recycling into the
petroleum refining process.
SPENT CAUSTIC SOLUTIONS FROM PETROLEUM REFINING (§261.4(a)(19))
EPA finalized an exclusion from the definition of solid waste for spent liquid
treating caustics from petroleum refineries used as feedstocks in the manufacture of
napthenic and cresylic acid products provided the spent caustics are not placed on
the land or speculatively accumulated (63 FR 42110; August 6, 1998). EPA believes
that spent caustic, when used in this manner, is a valuable commercial feedstock in
the production of these particular products, and thus is eligible for an exclusion.
2.2 HAZARDOUS WASTE EXCLUSIONS
The second type of exclusion found under §261.4 excludes certain materials from the
definition of hazardous waste. Section 261.4(b) lists the exceptions to the hazardous
waste definition. If a material is listed under §261.4(b), it is a solid waste, but cannot
be a hazardous waste, even if the material technically meets a listing in §§261.31
through 261.33 or it exhibits a characteristic under §§261.21 through 261.24 (i.e.,
ignitability, corrosivity, reactivity, or toxicity characteristic). If a waste excluded
under §261.4(b) is mixed with a listed or characteristic hazardous waste, it may
render the waste no longer excluded. Currently, there are 17 exclusions under
§261.4(b).
HOUSEHOLD WASTE (§261.4(b)(l))
Under §261.4(b)(l), household waste is exempt from the RCRA Subtitle C
regulations. The term household waste refers to any garbage, trash, and sanitary
waste from septic tanks derived from single and multiple residences, and other
residential units such as hotels and motels. In order for household waste to be
exempt from regulation, it must meet two criteria: the waste has to be generated by
individuals on the premises of a household, and the waste must be composed
primarily of materials found in the waste generated by consumers in their homes.
On November 13, 1984 (49 FR 44978), EPA expanded the definition of household
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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12 - Solid and Hazardous Waste Exclusions
wastes to include wastes from bunkhouses, ranger stations, crew quarters,
campgrounds, picnic grounds, and day-use recreation areas. Although the
collection, transportation, treatment, and disposal of household wastes are not
subject to Parts 262 through 270, they are subject to federal, state, and local
requirements concerning management of solid waste (45 FR 33066, 33099; May 19,
1980). This exclusion applies to all household waste, including household
hazardous wastes - wastes normally found in household wastestreams, such as
paint cans, batteries, and cleaning fluids. EPA has clarified that the household waste
exclusion applies to lead-based paint waste generated as a result of renovation,
remodeling, or abatement actions by residents of households (63 FR 70233, 70241;
December 18, 1998). In addition, this exclusion was to contractors conducting lead-
based paint activities in residences (Memo, Cotsworth to Regions; July 13, 2000).
AGRICULTURAL WASTE (§261.4(b)(2))
Solid wastes generated by crop or animal farming are excluded from hazardous
waste regulation provided the wastes are returned to the ground as fertilizers or soil
conditioners. Examples of such waste would be crop residues and manures.
Congress did not intend to include silviculture waste (i.e., forestry waste such as
foliage and branches) in this hazardous waste exclusion. As a result, generators of
forestry waste need to determine whether their waste is hazardous (45 FR 33066,
33099; May 19, 1980).
MINING OVERBURDEN (§261.4(b)(3))
Reclamation of surface mines commonly involves returning waste overburden (i.e.,
earth and rocks), removed to gain access to ore deposits, to the mine. EPA excluded
this waste because mining overburden is not a discarded material within the scope
of RCRA. This exclusion is limited to overburden that is overlying a mineral
deposit (45 FR 33000; May 19, 1980).
"BEVILL AND BENTSEN" WASTES (§§261.4(b)(4), (5), (7), and (8))
In the Solid Waste Disposal Act Amendments of 1980, Congress amended RCRA by
exempting fossil fuel combustion wastes; oil, gas, and geothermal exploration,
development, and production wastes; mining and mineral processing wastes; and
cement kiln dust wastes from regulation as hazardous waste under RCRA pending
further study by EPA. These wastes were temporarily exempted based on the
"special waste" concept, the belief that these wastes should be regulated less
stringently than other wastes because they were produced in large volumes, were
thought to pose less of a hazard than other wastes, and were generally not amenable
to the management practices required under RCRA. "Bevill and Bentsen" refers to
the two senators who proposed these statutory exemptions. The following sections
describe these exclusions in detail.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 13
FOSSIL FUEL COMBUSTION WASTE (§261.4(b)(4))
In order to accommodate effective study, fossil fuel combustion wastes were divided
into two categories, large volume coal-fired utility wastes and remaining wastes,
each having different schedules for regulatory determination.
On August 9, 1993, EPA made the final regulatory determination on the first
category, excluding large volume coal-fired utility wastes. Large volume coal-fired
utility wastes include fly ash, bottom ash, boiler slag, and flue gas emission control
waste generated at electric utility and independent power producing facilities using
coal that are not co-managed with low volume wastes (58 FR 42466, 42472). EPA
determined that these wastes do not warrant regulation under Subtitle C of RCRA,
and therefore remain excluded under §261.4(b)(4).
On May 22, 2000, EPA published the final regulatory determination for those
remaining fossil fuel combustion wastes not addressed by the 1993 regulatory
determination (65 FR 32214). Regulation of this second waste category was found
not to be warranted under Subtitle C of RCRA, therefore these remaining wastes
remain excluded under §261.4(b)(4).
The May 22, 2000, final regulatory determination also indicated that national
Subtitle D regulations are warranted for both categories of coal combustion wastes
disposed in landfills or surface impoundments, and that regulations under Subtitle
D (and/or possible modifications to existing regulations established under the
Surface Mining Control and Reclamation Act) are warranted when these wastes are
used for filling surface or underground mines. EPA believes that Subtitle D controls
will provide sufficient clarity and incentive for facilities to ensure that their wastes
are managed properly (65 FR 32214, 32217; May 22, 2000).
Low volume wastes, such as boiler blowdown, coal pile runoff, cooling tower
blowdown, demineralizer regenerant and rinses, metal and boiler cleaning wastes,
pyrites, and sump effluents, that are not co-managed with large-volume coal
combustion wastes are not included in either of these categories. Based on the
original scope of the exclusion, they have always been subject to Subtitle C
regulation when managed independently.
Fossil fuel combustion wastes that are generated by co-processing raw materials and
hazardous wastes are also exempt under this exclusion provided the wastes meet
specific criteria outlined in §266.112.
OIL, GAS, AND GEOTHERMAL WASTES (§261.4(b)(5))
In December 1987, EPA issued a Report to Congress that outlined the results of a
study on the management, volume, and toxicity of wastes generated by the
exploration, development, and production of crude oil, natural gas, and geothermal
energy. On July 6, 1988, EPA issued a final regulatory determination for these wastes
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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14 - Solid and Hazardous Waste Exclusions
which stated that Subtitle C regulation was not appropriate, thus permanently
excluding oil, gas, and geothermal wastes under §261.4(b)(5) (53 FR 25446). The July
6, 1988, Federal Register also clarified the scope of the exclusion by providing
examples of excluded wastes.
On March 22, 1993, EPA further clarified the scope of the exclusion in stating that
wastes that have been brought to the surface during oil and gas exploration and
production operations, or wastes that have otherwise been generated by contact with
the oil and gas production stream during the removal of produced water or other
contaminants, are generally covered by the exclusion (58 FR 15284).
MINING AND MINERAL-PROCESSING WASTES (§261.4(b)(7))
Under the current provisions of the RCRA mining waste exclusion, solid waste
from the extraction and beneficiation of ores and minerals, and 20 specific mineral
processing wastes are exempt from regulation as hazardous wastes under RCRA.
The mining waste exclusion was congressionally mandated by §3001(b)(3) of RCRA,
which was added through the 1980 Solid Waste Disposal Act amendments. This
provision referred to as the Bevill amendment, stopped EPA from regulating all
wastes from extraction, beneficiation, and processing until the Agency performed a
study, submitted a Report to Congress and determined whether or not the wastes
should continue to be excluded from Subtitle C regulation. EPA modified the
hazardous waste regulations to reflect this exemption, and issued a preliminary and
broad interpretation on the scope of the coverage (45 FR 76619; November 19, 1980).
In 1984, EPA was sued for failing to complete the required Report to Congress and
regulatory determination in conformance with the statutory deadline (Concerned
Citizens of Adamstown v. EPA). The court decision required EPA to address mining
wastes according to two schedules, one for completing the required study of
extraction and beneficiation wastes and the associated Report to Congress, and the
second for issuing a regulatory determination regarding mineral-processing wastes.
In 1985, EPA submitted a Report to Congress on waste from mineral extraction and
beneficiation. After studying the wastes, EPA concluded that Subtitle C regulation
was not appropriate for such wastes primarily because of the high volumes of wastes
generated. EPA clarified later that the term beneficiation included only activities
outlined in §261.4(b) (7) (i).
EPA failed, however, to meet the deadline for issuing the regulatory determination
for mineral processing wastes. As a result, the Agency was sued by a coalition of
environmental and special interest groups (Environmental Defense Fund v. EPA).
In July of 1988, the Agency was ordered to restrict the scope of the Bevill exclusion as
it applied to mineral-processing wastes so it included only "special wastes" which
were defined to be of such "high volume" and "low hazard" that management
under Subtitle C would be impracticable. During the years following the lawsuit,
EPA proposed and promulgated several rules redefining the boundary of the
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 15
exclusion for mineral-processing wastes. In 1991, EPA finalized a regulatory
determination limiting the exclusion to 20 specific mineral processing wastes. As a
result, all mineral processing wastes not specifically excluded in §261.4(b) (7) are
subject to hazardous waste regulations if characteristic.
In addition to the 20 mineral processing wastes specifically listed in §261.4(b)(7)(ii),
lightweight aggregate air pollution control dust and sludge remain conditionally
exempt from Subtitle C regulation. EPA will study this wastestream further before
issuing a final regulatory determination (64 £R 45632, 45655; August 20, 1999).
Beneficiation and processing of ores and minerals frequently occur in industrial
furnaces. These furnaces may co-process ores and minerals with hazardous waste as
feedstock. Residues from co-processing hazardous wastes with ores and minerals
only remain exempt from Subtitle C as long as more than 50 percent of the feedstock
is primary ores and minerals, and as long as the hazardous waste portion of the feed
does not significantly affect the concentrations of toxic compounds in the resulting
residue (§266.112).
In the vast majority of cases, mineral-processing wastes are generated from furnaces
(e.g., steel, copper, lead, and zinc). These mineral-processing wastes may be recycled
on or off site if the owner and operator comply with §261.4(b)(7)(iii). Figure 1
illustrates the three parts of the exclusion.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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16 - Solid and Hazardous Waste Exclusions
Figure 1
MINING WASTE AND MINERAL
PROCESSING EXCLUSION
MINING WASTE
MINERAL PROCESSING
| Benefication |
I
I
20 specific wastes currently excluded from
Subtitle C regulation §§261.4 (b) (7) (ii) (A)- (T)
These wastes are excluded from
Subtitle C regulation and are
defined in §261.4 (b) (7) (i)
1
These wastes are excluded from
regulation under Subtitle C
Potentially regulated under
Industrial Subtitle D program
CEMENT KILN DUST (§261.4(b)(8))
Pending a study of its potential hazards, EPA excluded cement kiln dust (CKD) from
the definition of hazardous waste. CKD is a fine-grained solid by-product generated
by the control of particulate matter in stack emissions at cement production
facilities. In December 1993, EPA issued the Report to Congress on Cement Kiln
Dust detailing the generation and management of CKD, as well as five options for
its future regulation. Then on February 7, 1995, EPA issued the final regulatory
determination of CKD (60 FR 7366). EPA concluded that CKD requires stricter
management controls, but should not be placed under full Subtitle C regulation. On
August 20, 1999, EPA proposed that CKD would remain a nonhazardous waste
provided that it is managed in landfills that meet groundwater protection and
fugitive dust control standards (64 FR 45632). In addition, EPA proposed tailored
Subtitle C regulatory standards for CKD that is not managed according to the
conditions of the exclusion. EPA also proposed concentration limitations on certain
pollutants in CKD that is used for agricultural purposes. Until the proposal is
finalized however, CKD remains exempt from regulation as a hazardous waste.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 17
Often fossil fuel is mixed with hazardous waste to heat cement kilns. CKD
generated in cement kilns in which fossil and hazardous waste fuels are combined
does not automatically fall within the scope of the exclusion. The CKD would
remain exempt from hazardous waste regulation only if the hazardous portion of
the feedstock does not significantly affect the concentrations of toxic compounds in
the resulting residue (§266.112).
TRIVALENT CHROMIUM WASTES (§261.4(b)(6))
Under §261.4(b)(6), wastes from certain industries that exhibit the toxicity
characteristic for chromium are excluded from the definition of hazardous waste.
Specific industries petitioned EPA (§260.20) to exclude their wastes from the
hazardous waste lists for the following reasons:
• The chrome they produce is nearly exclusively trivalent, which is not
considered to be hazardous
• Their process does not generate hexavalent chromium (a known carcinogen)
• The waste they produce is handled in a nonoxidizing environment (i.e., the
trivalent chrome could not oxidize to hexavalent chrome).
EPA agreed with the data submitted by these industries and on October 30, 1980 (45
FR 72035), excluded three groups of wastes:
• Tannery wastes described in §§261.4(b)(6)(ii)(A)-(F) (Wastes fitting these
descriptions had been listed as K053-K058, but these waste codes were
subsequently deleted (57 FR 72037; October 30, 1980))
• Leather scrap wastes from the leather tanning, shoe manufacturing, and other
leather manufacturing industries (§261.4(b)(6)(ii)(G))
• Wastewater treatment sludges from the production of titanium oxide (
pigment using chromium-bearing ores by the chloride process
(§261.4(b)(6)(ii)(H)) (waste fitting this description was listed as K074, but the
waste code was subsequently deleted (45 FR 72029, 72037; October 30, 1980)).
The exclusion is necessary despite the deletion of waste codes K053-K058 and K074
because these wastes could still exhibit the toxicity characteristic for chromium, since
the Toxicity Characteristic Leaching Procedure (TCLP) does not distinguish between
hexavalent and trivalent chromium.
Only chromium-bearing wastes from the three industry groups discussed above
automatically qualify for the exclusion. Other industries or individual generators
who believe their wastes meet the same criteria must petition the Administrator
under §260.20(a) to be added to this exclusion, or they may, under §260.22, petition
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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18 - Solid and Hazardous Waste Exclusions
EPA to delist the waste (45 FR 72036; October 30, 1980). For more information, see
the module entitled Petitions. Delistings. and Variances.
ARSENICALLY-TREATED WOOD (§261.4(b)(9))
Under §261.4(b)(9), a solid waste that consists of discarded arsenical-treated wood or
wood products that fails the TCLP for D004 - DO 17 only, and is not hazardous for any
other reason, is excluded from Subtitle C regulation (57 FR 30657; July 10, 1992).
Once such treated wood is used, it may be disposed of by the user (commercial or
residential) without being subject to hazardous waste regulation. This exclusion
was granted in response to a petition from the American Wood Preserving Institute
on the grounds that the use of arsenically-treated wood in contact with the ground
presents risks that are similar to land disposal of wood. Note that this exclusion
applies only to end-users and not to manufacturers. Wastes generated by sawmills
or facilities which apply the arsenic formulation to the wood are potentially
regulated under RCRA Subtitle C (45 FR 78530; November 25, 1980; and 55 FR 11798.
11839; March 29, 1990).
PETROLEUM-CONTAMINATED MEDIA AND DEBRIS FROM UNDERGROUND
STORAGE TANKS (§261.4(b)(10))
Until further studies are completed on the extent and threat of releases from
petroleum underground storage tanks (USTs), the Agency deferred the application
of the toxicity characteristic to petroleum-contaminated media and debris. This
deferral only applies to media and debris from USTs subject to the Part 280
corrective action requirements, and only to the 25-newly identified organic
constituents (D018 through D043) under the toxicity characteristic in §261.24 (55 FR
11836; March 29, 1990). EPA proposed to make this temporary deferral a permanent
exclusion (58 FR 8504; February 12, 1993), and the proposal is expected to become a
final rule in December 2003.
In order to fall under this exclusion, the waste must meet the specific criteria listed
above. For example, this exclusion would not apply if petroleum-contaminated soil
failed the TCLP for lead (D008), since lead is not a newly-identified waste under the
TCLP (it was previously identified as an EP waste). Rather, petroleum-contaminated
soil that is TC for lead would be subject to full regulation under Subtitle C. On the
other hand, if the soil only failed the TCLP for one of the new organic constituents,
such as benzene (DO 18), the soil would only be subject to the corrective action
requirements under Part 280.
HYDROCARBON RECOVERY OPERATIONS (§261.4(b)(ll))
Previously under §261.4(b)(ll), EPA excluded certain types of injected groundwater
that was reinjected as part of a hydrocarbon recovery operation (55 FR 46829;
November 27, 1990). This exclusion expired January 25, 1993.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 19
SPENT CHLOROFLUOROCARBON REFRIGERANTS (§261.4(b)(12))
Chlorofluorocarbons (CFCs) released to the atmosphere damage the ozone layer. To
promote recycling and discourage the practice of venting used CFCs into the
atmosphere in order to avoid Subtitle C regulation, the Agency has provided an
exclusion for CFCs that are recycled (i.e., reclaimed for reuse) (56 FR 5910; February
13,1991).
USED OIL FILTERS (§261.4(b)(13))
EPA has established an exclusion from the definition of hazardous waste for used
oil filters. This exclusion is only for non-terne plated used oil filters that are gravity
hot-drained by one of the following methods:
• Puncturing the filter anti-drain back valve or the filter dome end and hot-
draining (with this method, EPA recommends hot-draining for a minimum
of 12 hours)
• Hot draining and crushing
• Dismantling and hot-draining (EPA recommends separating each component
and recycling it)
• Any equivalent method of hot-draining that will remove the oil.
Terne-plated filters are not included in this exclusion because the terne-plated filters
often exhibit the toxicity characteristic for lead (D008), and are therefore subject to
Subtitle C regulation (i.e., a hazardous waste determination). In addition, used oil
that is removed from filters regardless of whether or not the filter is excluded, is
subject to regulation under the Part 279 used oil management standards. This
exclusion was originally codified in §261.4(b)(15) but was moved to §261.4(b)(13) (58
FR 26420; May 3, 1993).
USED OIL DISTILLATION BOTTOMS (§261.4(b)(14))
EPA exempted distillation bottoms from the re-refining of used oil from Part 279
regulation when the bottoms are used as ingredients in asphalt paving and roofing
materials (§279.10(e)(4)) (57 FR 41566; September 10, 1992). EPA's decision not to
regulate the bottoms is based on data indicating that these wastes do not exhibit the
toxicity characteristic and that common industry practices are protective of human
health and the environment. EPA codified a corresponding exclusion from the
definition of hazardous waste for this material in §261.4(b)(14) (58 FR 26420; May 3,
1993).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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20 - Solid and Hazardous Waste Exclusions
LEACHATE OR GAS CONDENSATE FROM LANDFILLS CARRYING THE K169,
K170, K171, AND K172 LISTINGS (§261.4(b)(15))
Landfill leachate and landfill gas condensate derived from wastes disposed before
February 8, 1999, that would now meet the listing description of one or more of the
petroleum refinery listed wastes, K169, K170, K171, and K172, are deferred from the
definition of hazardous waste provided their discharge is regulated under CWA.
Additionally, they can not be managed in surface impoundments after February 13,
2001, unless the surface impoundment has a double liner and is only used to
temporarily store landfill leachate or landfill gas condensate in the event of an
emergency (64 FR 6806; February 11, 1999). The exclusion does not apply to leachate
or gas condensate that exhibits any of the characteristics of hazardous waste or is
derived from any waste codes other than the four petroleum refinery wastes
described in the exclusion. Any residue generated from treating excluded leachate
or gas condensate must also be evaluated to determine if it exhibits a characteristic.
This exclusion will remain effective while EPA examines the specific aspects of how
the landfill leachate and landfill gas condensate are currently managed, whether
Subtitle C regulation is appropriate, and the affect of the future CWA effluent
limitation guidelines for landfill wastewaters.
PROJECT XL PILOT PROJECT EXCLUSIONS (§§261.4(b)(16) & (18))
Project XL provides some regulated entities an opportunity to develop common
sense, cost-effective strategies that will replace or modify specific regulatory
requirements, on the condition that they produce and demonstrate superior
environmental performance.
The IBM Vermont XL project will determine whether the wastewater treatment
sludge resulting from an innovative copper metallization process should be exempt
from designation as a RCRA hazardous waste. The September 12, 2000, final rule
provides a pilot exemption for the copper metallization process from the F006
listing (65 FR 54955) (§261.4(b)(16)).
The May 9, 2001, final rule provides the Autoliv ASP Inc. facility in Promontory,
Utah, with a site-specific conditional exclusion (66 FR 23617). By-products resulting
from the production of automobile air bag gas generants at that facility are exempt
from the D003 listing until May 9, 2006 (§261.4(b)(18)).
2.3 EXCLUSIONS FOR RAW MATERIAL, PRODUCT AND
PROCESS UNIT WASTES
Under §261.4(c), hazardous waste generated in raw material, product storage, or
manufacturing units is excluded from Subtitle C regulation, as long as the waste
remains in the unit. These units include tanks, pipelines, vehicles, and vessels used
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 21
either in the manufacturing process, or for storing raw materials or products, but
specifically do not include surface impoundments (45 FR 72024; October 30, 1980).
Once the waste is removed from the unit, the waste is considered to be generated
and is subject to regulation. Thus, the generator accumulation standards apply once
the waste is removed from a unit, or when a unit temporarily or permanently
ceases operation for more than 90 days.
2.4 SAMPLE AND TREATABILITY STUDY EXCLUSIONS
Because samples are small, discrete amounts of hazardous waste that are essential to
accurate characterization and proper hazardous waste management, EPA developed
two types of exclusions for lab samples. The regulations distinguish between and
create separate requirements for characterization samples (§261.4(d)) and treatability
study samples (§§261.4(e) and (f)).
WASTE CHARACTERIZATION SAMPLES (§261.4(d))
EPA excluded small samples of wastes from the requirements of Parts 262 through
268, 270, 124, and the notification requirements under RCRA §3010, provided that
the samples are collected and shipped for the sole purpose of determining
hazardous waste characteristics or composition (46 FR 47426; September 25, 1981).
Storage, transportation, and testing of the sample are excluded from RCRA
regulation even when the lab testing is complete, provided the sample is returned
to the generator, and as long as the specific provisions in §261.4(d) are met. When
shipping the sample to or from the laboratory, the sample collector or lab personnel
must comply with certain labeling requirements, as well as any applicable U.S.
Postal Service or Department of Transportation shipping requirements
(§261.4(d)(2)).
The lab sample exclusion is intended to apply to small samples. Although the
regulations do not specify a size limit, EPA has stated that typically no more than
one gallon is needed to completely characterize a sample for purposes of compliance
with RCRA or other federal, state, or local regulations (46 FR 47426, 47427;
September 25, 1991).
TREATABILITY STUDY SAMPLES (§§261.4(e) and (f))
Various industry groups and individuals expressed concern that the waste
characterization sample exclusion was too restrictive. In response to these
comments, EPA developed regulations for waste samples used in small-scale waste
treatability studies. Treatability studies are used to determine information such as
whether a treatment process is efficient, or what types of wastes remain after the
treatment is complete. Section 261.4(e) conditionally excludes from the
requirements of Parts 261 through 263 and the notification requirements of RCRA
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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22 - Solid and Hazardous Waste Exclusions
§3010, persons who generate or collect samples for the sole purpose of conducting
treatability studies provided the conditions in §§261.4(e)(l) through (3) are met.
These requirements include packaging, labeling, and recordkeeping.
Both the treatability samples and the laboratories conducting such treatability
studies are excluded from the requirements in Parts 261 through 266, 268, and 270,
and the notification requirements of RCRA §3010 as long as the provisions in
§§261.4(f)(l) through (11) are met. On February 18, 1994, EPA modified the
treatability study exclusions by increasing the time and quantity limits for
contaminated media and debris (59 FR 8362).
2.5 DREDGED MATERIAL EXCLUSION (§261.4(g))
Dredging large volumes of sediment from United States waters is a common
practice used to maintain navigable waterways, ports and marinas. Excavated
dredged material is currently disposed in the ocean at designated sites in accordance
with MPRSA. Additional options for disposing of dredged material exist under
CWA, including discharge into open waters of the United States, discharge to
confined disposal facilities located in the United States, and the beneficial use of
dredged material. Prior to the promulgation of this exclusion, if dredged material
proposed for disposal in the aquatic environment was contaminated or suspected of
being contaminated with hazardous waste, the potential application of both RCRA
Subtitle C regulations and the dredged material regulations under CWA or MPRSA
complicated efficient assessment and management of dredged material. In order to
avoid duplicative regulation, dredged material subject to a permit that has been
issued under §103 of MPRSA, or §404 of CWA is excluded from the definition of
hazardous waste (63 FR 65874, 65921; November 30, 1998).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Solid and Hazardous Waste Exclusions - 23
3. SPECIAL ISSUES
Although the scope of the exclusions is usually straightforward, there are many
issues requiring clarification beyond the regulatory or statutory descriptions of the
exclusions. This section discusses a few of these issues that can arise during Call
Center calls.
3.1 FEDERALLY OWNED TREATMENT WORKS
The original exclusion for domestic sewage and mixtures of domestic sewage only
applied to wastes that passed through a sewer system to a publicly owned treatment
works (§261.4 (a) (1)); however, the Federal Facilities Compliance Act of 1992
amended RCRA's statutory language in §1004(27) to include solid or dissolved
material introduced by a source into a federally owned treatment works. This
expanded the scope of the exclusion to include both publicly owned treatment works
and federally owned treatment works.
3.2 HOUSEHOLD WASTE COLLECTION PROGRAMS
Based on the exclusion found in §261.4(b)(l), household wastes are solid wastes that
are exempt from the definition of hazardous waste, but are still subject to Subtitle D
regulation. This exclusion extends to those who collect household hazardous waste,
either in community collection programs or private sector collection programs.
Household hazardous waste that is mixed with small quantity or large quantity
generator wastes, however, may be subject to full Subtitle C regulation.
3.3 MUNICIPAL WASTE COMBUSTION ASH
Municipal waste combustion ash (MWC) generated by waste-to-energy (WTE)
facilities burning household waste and nonhazardous commercial and industrial
waste is not exempt from Subtitle C regulations based on a judicial interpretation of
RCRA §300 l(i). The court stated that even though the waste-to-energy facilities
remain exempt from Subtitle C requirements as treatment, storage, or disposal
facilities based on RCRA §300 l(i), the ash they produce is subject to hazardous waste
determination under Subtitle C (60 FR 6666; February 3, 1995). The regulation of
municipal waste
combustion ash will be discussed in further detail in the module entitled Solid
Waste Programs.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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24 - Solid and Hazardous Waste Exclusions
4. REGULATORY DEVELOPMENTS
In recent years, EPA has proposed new exclusions from the definition of solid and
hazardous waste. The following is a brief discussion of the proposed exclusions.
4.1 DEFERRAL FROM RCRA FOR THE MANAGEMENT AND
DISPOSAL OF LEAD-BASED PAINT DEBRIS
EPA proposed to temporarily suspend the applicability of the toxicity characteristic
for lead to lead-based paint (LBP) debris generated at target housing and public and
commercial buildings for which management and disposal standards have been
proposed under Toxic Substances Control Act (TSCA) Title IV (63 FR 70233;
December 18, 1998). EPA studies indicate that under the new TSCA standards, LBP
debris will be identified, managed, and disposed of in a less costly and more time
efficient manner than current RCRA regulatory requirements permit. EPA expects
to publish a final rule in August 2002.
4.2 PETROLEUM-CONTAMINATED MEDIA AND DEBRIS FROM
NON-USTS
The Agency has proposed a separate three-year exclusion for petroleum-
contaminated media and debris from non-USTs (e.g., aboveground tanks, pipelines,
and transportation vehicles) (57 FR 61542; December 24, 1992). The suspension
would only apply in states which certify that they have an effective program in place
to compel cleanup of spills and control disposal of these wastes, and that the cleanup
is state-supervised, state-approved, or under federal authority.
EPA stated in the final Hazardous Waste Identification Rule for media (HWIR-
media), that it plans to continue reviewing the issues addressed in the proposal, but
that no final regulatory determination would be taken at the present time (63 FR
65874, 65931-65932; November 30, 1998). Until EPA takes final action in specifically
addressing petroleum contaminated media and debris, petroleum-contaminated
media and debris from non-USTs are subject to hazardous waste regulations if they
exhibit a characteristic or contain a listed hazardous waste.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
-------
Solid and Hazardous Waste Exclusions - 25
4.3 GLASS FRIT AND FLUORIDE-RICH BAGHOUSE DUST
GENERATED BY THE VITRIFICATION OF K088
The vitrification of spent potliners from primary aluminum reduction (K088)
generates two residues: glass frit and fluoride-rich baghouse dust. Glass frit is usable
as a commercial product and fluoride-rich baghouse dust can be recycled back into
the aluminum reduction pots as electrolyte or sold as a product for other industrial
uses such as steel making. On July 12, 2000, EPA proposed that glass frit and
fluoride-rich baghouse dust generated by the vitrification of K088 be classified as
products and excluded under §§261.4 (a) (20) and (21); respectively, provided certain
conditions are satisfied (65 FR 42937).
4.4 ZINC FERTILIZERS MADE FROM RECYCLED HAZARDOUS
SECONDARY MATERIALS
EPA proposed a conditional exclusion from the definition of solid waste at
§261.4(a)(20) for hazardous secondary materials that are recycled to make zinc
fertilizers or zinc fertilizer ingredients (65 FR 70954; November 28, 2000). Generators
would no longer be subject to current hazardous waste management regulations,
provided the generator meets the specified conditions relating to accumulation,
storage, transportation, reporting and recordkeeping requirements of excluded
materials.
The November 28, 2000, proposal included a second conditional exclusion at
§261.4(a)(21) for zinc fertilizers made from hazardous wastes or excluded hazardous
secondary materials (65 FR 70954, 70967). Manufacturers would need to meet the
proposed technology-based contaminant limits, and maintain analytical data and
analyses demonstrating compliance with the limits.
4.5 PROJECT XL SITE-SPECIFIC EXCLUSION
EPA proposed to implement a pilot project under the Project XL program that
would provide regulatory flexibility for the IBM semiconductor manufacturing
facility in Hopewell Junction, New York (66 FR 30349; June 6, 2001). The objective of
the project is to determine whether the wastewater treatment sludge resulting from
the treatment of wastewaters from electroplating operations, F006, may be used as an
ingredient in the manufacture of cement in an environmentally sound manner
without full RCRA regulatory controls. The proposal provides a conditional
exclusion from the definition of solid waste, at §261.4(a)(22) for IBM's wastewater
treatment sludge which would allow the recycling scenario to be implemented on a
pilot basis.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
-------
Medical Facility Organization Chart: Operations
Exercise 1
Director of
Patient Care
Patient Care
Staff
Facility
Manager
Hospital
Director
Director of
Operations
Chief of
Staff
Business
Practice
Manager
Protection &
Support
Manager
Resources
Manager
Medical &
Research
Staff
-------
Asped/Impact
Exercise 2
Activity, Product, Service
Aspects
Impacts
-------
Significance Matrix
Exercise 3
Activity, Product or Servic
Aspect
Impact
Legal
Liability
>e: Janitorial services / hiqh level disinfecting and cleaning procedures
Public
Concern
Frequency
Severity
Degree of
Control
Score
Significant?
-------
Exercise 4
Environmental Management Program (BMP) Matrix
Record No.: xx Objective No.: 12, reduce hazardous chemical use by x% within 2 years.
Significant Aspect: Hazardous Chemical Use in Laboratory
Description: Reorganize the laboratory chemical procurement, inventory, and tracking systems to enable reduction in use and disposal
of hazardous chemicals.
Date: 05/01/06
TARGET
DATE FOR
COMPETION
ACTIONS
RESONSmiLITY
RESOURCES
OBJ12T1:
OBJ 12 T2:
OBJ12T3:
OBJ 12 T4:
-------
Training
EXERCISE 5
Potential environmental training could include, but not limited to:
Federal
State
Local
Air
Water
Hazardous
Waste
Environmentally
Preferred
Purchasing
Stormwater
Green building
Energy use
Cleaning
chemicals
Oil
Medications
Chemotherapy
What not to
touch
Pesticides
Director
Lab
Technician
Purchasing
Official
Construction
Contractor
Cook
Mechanic
Physician
Pharmacist
Oncology
Nurse
Grounds
keeper
Volunteer
-------
Operation Controls
EXERCISE 6
For each of the activities/processes listed on the left, provide an example of an operational control from the list on
the right that could address a significant environmental impact associated with each activity/process:
Activity/Process Operation Control
Administration of antineoplastics Monitoring equipment
Operation and maintenance of refrigerators Inspection checklist
Autopsy/morgue operations Tracking procedures
Sampling and testing protocols
Equipment settings
Routine maintenance
-------
9574.1990(01)
PROPER DISPOSAL OF OLD MEDICATIONS
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
NOV 28 1990
Marilynne Wilson, RN
Quality Assurance Coordinator
Family Home Care
P.O. Box 2145
Spokane, Washington 99210-2145
Dear Ms. Wilson:
Thank you for your letter dated October 12,1990 regarding the proper disposal
of old medications.
Expired medications from households may fall into the category of household
hazardous waste. Household hazardous waste (HHW) is appropriately
identified by applying two criteria. First, the waste must be generated by
individuals on the premises of a temporary or permanent residence for
individuals. Second, the waste stream must be composed primarily of materials
found in the waste generated by consumers in their homes. Other items that
may fall into this category may include excess household cleaners, lawn and
garden products, and paint thinners, among others, when intended for disposal.
Based on the information in your letter, it is not clear whether the medication
you manage qualifies as HHW. However, you should be able to determine the
regulatory status of the material based on the aforementioned criteria. At the
Federal regulatory level, HHW is excluded from hazardous waste regulations
under Subtitle C of the Resource Conservation and Recovery Act (RCRA). Please
note that state or local regulations may be more stringent than Federal
regulations.
Although household hazardous waste is excluded from Subtitle C regulations,
the Environmental Protection Agency (EPA) shares concerns such as yours
regarding household hazardous waste. In fact, EPA attempts to address some of
these concerns in the enclosed publication entitled A Survey of Household
Hazardous Wastes and Related Collection Programs. This report contains the
results of a comprehensive nationwide survey of HHW. In this publication the
Agency identifies: existing information on the types and quantities of HHW; the
impacts of HHW on homeowners, solid waste collection and disposal personnel,
RO 13432
-------
and the environment; and existing collection programs at the state and local
levels. You may also be interested in the enclosed publication Household
Hazardous Waste: Bibliography of Useful References and List of State Experts
which lists resources and contacts for HHW programs.
With regard to disposal of old medications, rinsing the bottles and flushing this
type of waste down a toilet may be the most appropriate method of disposal.
Additionally, most pharmacists recommend flushing expired tablets and
capsules down the toilet. By disposing of these normally minute quantities of
household waste in this fashion, the possibility of exposing children that might
be attracted to the potentially harmful materials while in the trash is removed.
Federally, any mixture of domestic sewage and other wastes that pass through a
sewer system to a publicly owned treatment works (POTW) for treatment is not
regulated under Subtitle C.
I suggest you consult your local publicly owned treatment works (POTW) to
determine if local limits or general/specific prohibitions are applicable when
disposing of expired medications in this manner. I also suggest you contact your
state solid waste program office to determine if they can provide additional
HHW disposal guidance. The address in Washington is:
Solid And Hazardous Waste Management Division
Department of Ecology
Mail Stop PV-11
Olympia, Washington 98504
(206) 459-6316
Thank you for your interest in proper waste management. I hope this
information is useful when determining the appropriate disposal options for
expired medications.
Sincerely,
Mike Petruska, Chief
Waste Characterization Branch
Enclosures
RO 13432
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FACILITY AUDIT AGREEMENT
between the
ENVIRONMENTAL PROTECTION AGENCY
and
[Insert Name of Hospital!
I. INTRODUCTION
In recognition that environmental auditing plays a critical role in protecting human health
and the environment by identifying, correcting, and ultimately preventing violations of
environmental regulations, [Hospital] and the United States Environmental Protection
Agency, Region 2 (the "Region") hereby agree that [Hospital] shall conduct a self-audit
program (the "Audit Program") for compliance with the regulations promulgated or
authorized by the United States Environmental Protection Agency ("EPA") set forth in
Section n below. The Agreement shall be governed by the terms of EPA's Policy
entitled "Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention
of Violations," 65 Federal Register 19618 (4/11/00, the "Policy"), except to the extent
that those terms are explicitly modified below.
II. SCOPE OF THE AUDIT
A. [Hospital] shall conduct an audit (the "Audit") of its compliance with the
regulations cited below in subsections 1 - 6 of Section n.B. The Audit will
encompass all / (enter number) campuses of [Hospital], including any
associated off-site facilities such as (if applicable). Appendix A
attached hereto lists the campuses and other units associated with each covered
campus ("Covered Campuses") that are covered by this agreement.
B. Under the Audit Program, [Hospital] will audit compliance with the following
federal regulatory programs:
1. Air Programs
Part 521 Section 21 Prevention of Significant Deterioration of Air Quality
Part 60 Standards of Performance for New Stationary Sources
Part 61 National Emission Standards for Hazardous Air Pollutants, Subpart M,
National Emission Standard for Asbestos
Part 62 Subpart HHH - Federal Plan Requirements for
Hospital/Medical/Infectious Waste Incinerators
Part 63 National Emission Standards for Hazardous Air Pollutants for Source
Categories (all applicable provisions)
1 The term "Part" refers to the subdivisions of the subchapters of Title 40 Code of Federal
Regulations ("C.F.R.").
Page 1 of 13
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Part 68 Chemical Accident Prevention Provisions
Part 70 State Operating Permit Programs
Part 82 Protection of Stratospheric Ozone
All applicable provisions of; and the New York State Implementation Plan
Regulations (promulgated pursuant to Section 110 of the Clean Air Act) including
the New Source Review regulations
2. Water Programs
Part 112 Oil Pollution Prevention
Part 122 EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System
Part 141 National Primary Drinking Water Regulations
Part 142 National Primary Drinking Water Regulations Implementation
Part 143 National Secondary Drinking Water Regulations
Part 144 Underground Injection Control ("UIC") Program
Part 145 State UIC Program Requirements
Part 146 UIC Program: Criteria and Standards
Part 147 State UIC Programs
Part 148 Hazardous Waste Injection Restrictions
Part 403 General Pretreatment Regulations for Existing and New Sources of
Pollution
3. Pesticide Programs
Part 160 Good Laboratory Practice Standards
Part 162 State Registration of Pesticide Products
Part 170 Worker Protection Standard
Part 171 Certification of Pesticide Applicators
Part 172 Experimental Use Permits
4. Solid and Hazardous Wastes
Part 260 Hazardous Waste Management System: General (Part 370, 6 New York
Code of Rules and Regulations ("6 NYCRR")2
Part 261 Identification and Listing of Hazardous Waste (Part 371, 6 NYCRR)
Part 262 Standards Applicable to Generators of Hazardous Waste (Part 372, 6
NYCRR)
2 New York State has been authorized by the Region for many of the federal regulations
comprising Parts 260 - 280. Once authorized, a state regulation becomes the applicable regulation.
[Resource Conservation and Recovery Act ("RCRA"), as amended, §3006(b), 42 U.S.C. §6926(b)]. For
purposes of this Agreement [Hospital] will audit for compliance with authorized New York State
counterparts of the federal regulations, where applicable, found at 6 NYCRR Parts 370 -373 and Subpart
374-3.
Page 2 of 13
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Part 263 Standards Applicable to Transporters of Hazardous Waste (Part 372, 6
NYCRR)
Part 264 Standards for Owners and Operators of Hazardous Waste Treatment,
Storage, and Disposal Facilities (Subpart 373-2, 6 NYCRR)
Part 265 Interim Status Standards for Owners and Operators of Hazardous
Waste Treatment, Storage, and Disposal Facilities (Subpart 373-3, 6
NYCRR)
Part 266 Standards for the Management of Specific Hazardous Wastes and
Specific Types of Hazardous Waste Management Facilities (Subpart
3 74-1,6 NYCRR)
Part 268 Land Disposal Restrictions (Part 376, 6 NYCRR)
Part 273 Standards for Universal Waste Management (Subpart 374-3, 6
NYCRR)
Part 279 Standards for the Management of Used Oil
Part 280 Technical Standards and Corrective Action Requirements for Owners
and Operators of Underground Storage Tanks ("USTs")
5. Hazardous Substances and Chemicals, Environmental Response, Emergency
Planning, and Community Right-to-Know Programs
Part 302 Designation, Reportable Quantities, and Notification
Part 355 Emergency Planning and Notification
Part 370 Hazardous Chemical Reporting: Community Right-to-Know
Part 372 Toxic Chemical Release Reporting: Community Right-to-Know
6. Toxic Substances
Part 745 Lead-Based Paint Poisoning Prevention in Certain Residential
Structures
Part 761 Polychlorinated Biphenyls (PCBs) Manufacturing, Processing,
Distribution in Commerce, and Use Prohibitions
Part 763 Asbestos
C. The facilities and documents to be audited on the Covered Campuses are set forth
in Appendix B. The benefits of this Agreement shall extend to only those
facilities within the Covered Campuses that are audited.
III. DISCLOSURE
[Hospital] shall disclose all regulatory violations discovered during the Audit.
[Hospital] will disclose these violations to the Region, in accordance with the Policy, in
written disclosure reports to be submitted in accordance with the schedule set forth below
in Section IV. Each such disclosure report shall contain, with reference to each violation
disclosed, the following additional information: the actions selected by [Hospital] to
correct the violation within 60 days, or as otherwise approved pursuant to Section V
Page 3 of 13
-------
below; the status of the corrective action; and the means taken by [Hospital] to prevent
recurrence of the violation. All disclosure reports will be submitted by the scheduled
date, and the Region agrees to waive the 21-day disclosure requirement provided for in
the Policy.
Once the action designed to correct a particular violation has been completed, and a
report submitted to the Region notifying it of the completion of the corrective action, no
further reporting on that violation, or the status of corrective action, is required. On
[Date of Termination of Agreement - usually sixty days after submittal of last
disclosure report], this Agreement shall terminate for all purposes, except that
[Hospital] shall remain obligated to complete the action necessary to correct any
disclosed violation, and to report to the Region in writing the completion of any
corrective action, previously unreported, within thirty days after such corrective action
has been completed.
This Audit Agreement does not cover any pre-Agreement activities, including regulatory
compliance issues discovered by [Hospital] or its environmental consultants) prior to
the effective date of this Agreement.
IV. SCHEDULE
A. Within 10 days of the effective date of this agreement, [Hospital] will identify
suitable personnel or consultants (where appropriate) to perform each of the six
regulatory program audits identified in Section n above and shall further identify
the applicable criteria pursuant to which each such regulatory program audit shall
be conducted. [Hospital] shall submit to EPA the audit protocols and audit
checklists for each of the six regulatory program audits, tailored to the Hospital,
and shall provide copies of these audit instruments to the Region. [Hospital] is
willing to share any materials it develops with other healthcare institutions and
the Region.
B. Within 30 days of the signing of the agreement, the Audit shall commence.
C. [Hospital] shall complete the regulatory audits required by the Sections listed in
this agreement, and shall submit disclosure reports to the Region, in accordance
with the Policy and the Agreement, identifying all violations discovered during
the course of these audits according to the schedule set forth in Appendix C.
V. CORRECTIVE ACTION
[Hospital] shall correct each violation identified during the Audit, and shall take steps
necessary to prevent the recurrence of each such violation. Wherever possible, [Hospital]
shall correct any violations identified during the Audit within 60 days of discovery. In
those instances in which [Hospital] is unable to correct an identified violation within the
60-day deadline, it shall request an extension of time from the Region in writing and
Page 4 of 13
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provide a correction schedule, accompanied by a justification of the requested extension.
Any extension of the 60-day correction period shall be subject to the Region's approval.
Such approval will not be unreasonably withheld.
If [Hospital] discovers or otherwise becomes aware of a concern or concerns that may
present an imminent and substantial endangerment to human health or the environment,
and such concern(s) may exist at other [Hospital] campuses covered by this Agreement,
notwithstanding any other language herein to the contrary, [Hospital] agrees to address
such concern(s) at all covered campuses as expeditiously as possible and promptly take
such action as may be necessary at all covered campuses to protect human health and the
environment. [Hospital] shall notify EPA (initial notice may be by phone) of such
concern(s) within 24 hours of discovery or becoming aware of such concern(s) and shall
notify EPA in writing within five business days of such discovery of [Hospital] 's
proposed remedial action.
VI. CIVIL PENALTIES FOR DISCLOSED VIOLATIONS
Except as provided in Section n.D.8 of the Policy, the Region will not impose gravity-
based penalties for violations discovered if they are timely disclosed and corrected, and
provided that the applicable provisions of the Policy and this Agreement are met. The
Region will consider the least expensive means for coming into compliance for
calculating potential economic benefit penalties for any disclosed violations, provided
that such methods comply with regulatory requirements.
VII. REGIONAL INSPECTIONS
The Region will assign a low priority for compliance inspections at the Covered
Campuses until after the completion of the Audit, except with respect to potential
violations of regulatory provisions, or at facilities, that are outside the scope of the Audit,
as defined in Section n above, or where: the Region has received a citizen's complaint;
the Region has reason to believe that circumstances exist that may pose a threat of actual
harm or an imminent and substantial endangerment to public health or the environment;
the Region has reason to believe that a criminal violation may, or has occurred; or where
[Hospital], pursuant to statute, has notified the National Response Center of a release.
Any civil violation discovered in a facility or unit within the scope of the Audit, that was
scheduled to be audited subsequent to such discovery, shall be treated as a disclosure by
[Hospital] and resolved under the terms of the Policy and this Agreement. Additionally,
the Region retains the right to conduct during the Audit the inspections set forth in
subsections A and B immediately below:
A. Oversight Inspections: Where [Hospital] has reported a violation that requires
corrective action in the nature of a clean-up of contaminated soil or water, the
Region shall have the right to conduct inspections at the corrective action site for
the purpose of overseeing or monitoring the clean-up, to assure correction of the
violation. No civil penalties shall be associated with or result from oversight
Page 5 of 13
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inspections, unless circumstances exist that may pose a threat of actual harm or an
imminent and substantial endangerment to public health or the environment.
B. Confirmation Inspections: Where [Hospital] has disclosed a violation, selected a
corrective action plan, and reported that the plan has been completed and the
violation cured, the Region shall have the right to inspect the relevant facility or
site to assure that the violation has in fact been corrected, or to require further
appropriate corrective action, if it has not. No civil penalties shall be associated
with or result from confirmation inspections, unless circumstances exist that may
pose a threat of actual harm or an imminent and substantial endangerment to
public health or the environment.
VIII. MISCELLANEOUS PROVISIONS
A. Notification and Certification of Disclosure Reports: [Hospital] designates as its
"responsible official," responsible for submitting disclosure reports to the Region,
the following individual:
Name of Responsible Official
Title
Name of Hospital
Address
City, State, Zip Code
Phone Number
Fax Number
The responsible official shall certify that each disclosure report submitted to the
Region is true, accurate and complete in the form set forth in 40 C.F.R
§270.11(d).
[Hospital] designates as its "contact person," to be the recipient of all
communications from the Region concerning this Agreement, the following
individual:
Name of Contact Person
Name of Hospital
Address
City, State, Zip Code
Phone Number
Fax Number
Email Address
The Region designates the following individual as its contact person:
Charles Zafonte
Multimedia Enforcement Coordinator
Page 6 of 13
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DECA/CAPSB
U.S. Environmental Protection Agency, Region 2
290 Broadway (21ST Floor)
New York, New York 10007-1866
Phone:(212)637-3515
Fax: (212)637-4086
zafonte. charles@,epa. gov
The parties may redesignate their contact person and responsible official in
writing.
B. Compliance With Law and Regulation: Neither the existence of this Agreement,
nor compliance with this Agreement relieves [Hospital] of its obligation of
continued compliance with the regulations covered by this Agreement, and all
other federal, state and local laws and regulations.
C. Reservation of Right: The Region reserves its right to proceed against
[Hospital] for all violations outside the scope of the Audit, and violations within
the scope of the Audit that were not timely reported or timely corrected. In any
enforcement proceeding, the Region may enforce the provision of 40 C.F.R.
allegedly violated, or its New York State authorized or approved counterpart, if
said state counterpart is federally enforceable as a matter of law.
D. Authority of Signatories: The signatories hereto represent that they have the
authority to bind the parties.
E. Modification: This Agreement may be modified by a writing signed by both
parties.
F. Coordination With the State Environmental Agency: The Region has informed
NYSDEC of this Agreement and shall provide a copy to NYSDEC at each of the
following addresses:
Mr. James H. Ferreira, Esq.
Deputy Commissioner and General Counsel
NYS Department of Environmental Conservation
625 Broadway
Albany, NY 12233-1010
Name
Regional Director, Region ?
NYS Department of Environmental Conservation
Street
City, NY Zip
Page 7 of 13
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Nothing herein, however, restricts NYSDEC from acting as it deems appropriate.
WE, THE UNDERSIGNED, HEREBY AGREE TO BE BOUND BY THIS AGREEMENT:
For [Hospital!:
Name of Responsible Official
Title
Address
City, State, Zip Code
Date:
For EPA-Region 2:
Jane M. Kenny, Regional Administrator
USEPA - Region 2
290 Broadway
New York, New York 10007
Date:
Page 8 of 13
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Appendix A
Covered Campuses and Off-Site Facilities Associated with Those Campuses
[List of Campuses and off-site facilities covered under the Audit Agreement goes here.]
Page 9 of 13
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Appendix B
SCOPE OF AUDIT PROGRAM
The following list provides the activities, areas, and/or shops that the review of the campus(es)
must cover. This list not meant to be all-inclusive. [Please select and include areas that exist at
your campus.]
Documents to Review (for the three years prior to the Program Period)
• Verify EPA identification numbers and permits
• Hazardous waste manifests
• Training records
• Land disposal restriction notifications
• Exception reports
• Lead disclosure statements in leases, or associated with leases of residential housing let by
the university in its capacity as a lessor, as defined in 40 C.F.R. § 745.103
• Contingency plans and annual reports (for contingency plans, only the current plan will be
reviewed)
• Required certifications
Facilities Operation and Maintenance
• Air conditioning/refrigeration service
• Appliance and equipment repair, including medical equipment
• Building cleaning and maintenance
• Building renovation and construction
• Cafeteria
• Chemical storage areas
• Drinking water treatment systems
• Fabrication shops
• Furniture repair
• Heating and power plants (e.g., boilers, emergency generators)
• House or architectural structure painting
• Landscaping operations
• Laundry
• PCB transformers and switches
• Pesticide storage facilities
• Resource recovery/incinerator facilities
• Waste disposal areas (landfills)
• Wastewater treatment facilities
• Waste treatment facilities such as autoclaves
Fleet Maintenance
-------
• Automotive, truck, and ambulance servicing areas
• Gasoline service stations
• Garages
Hazardous Waste / Tanks / Wells
• Aboveground and current operating underground storage tanks and their containment
areas/systems, and documentation concerning closures of regulated tanks previously
removed from service.
• Dry wells, septic systems, cesspools, floor drains, sink drains, and disposal wells.
• Facilities treating, storing or disposing of hazardous wastes.
• Hazardous waste satellite accumulation areas.
• Hazardous waste storage areas.
• Tanks that have been permanently or temporarily closed.
• Transformers and oil-containing electrical equipment (PCB and non-PCB).
• Universal waste storage areas.
Laboratories
• All clinical, pathology and dental laboratories
• All teaching and research laboratories with regular chemical use.
Patient Care
• Anesthesiology
• Chemotherapy
• Dentist's offices
• Doctor's offices
• Floor Pharmacies
• Histology
• Intensive Care Units
• Neonatal Areas
• Nursing Stations
• Operating Rooms
• Pathology, microbiology
• Patient's Rooms
• Patient treatment areas
• X-Ray/Radiology
Main Pharmacy
• Storage areas
• Outdated pharmaceuticals
Sterile Supply and Materials Management
• Autoclaving Units
• Ethylene Oxide (EtO) Units
-------
• Glutaraldehyde
• Use and disposal of disinfectants
Use and Disposal of Known Chemicals/Products of Concern
• Computers/monitors, circuit boards, and other lead-bearing electronics
• Ethanol and formaldehyde/ethanol solutions
• Fluorescent light bulbs and other types of lamps, including high-intensity discharge, neon,
mercury vapor, high pressure sodium, and metal halide lamps
• Formaldehyde/Formalin
• Mercury and Mercury-containing devices and products
• PVC-containing devices
• Xylene
• Batteries
• Solvents
• Photographic chemicals and scrap film
Other Services
• Athletic and training facilities
• Photo processing/publishing
• Morgue/Crematorium
• Animal care areas
-------
Appendix C
SCHEDULE OF AUDITS
[Insert a schedule of when audits will be done at each campus/location. Provide details as
necessary such as deadlines for submitting the disclosure report, the regulatory areas being
audited, and the names of campuses, buildings, or other location-specific info.]
Example:
Location
Campus A e.g.:
Pharmacy
Physical Plant
Print Shop
Programs to be Audited
e.g., RCRA, CWA
Date Disclosure Report will be Submitted
-------
FACILITY AUDIT AGREEMENT
between the
ENVIRONMENTAL PROTECTION AGENCY
and
[Insert Name of Hospital!
I. INTRODUCTION
In recognition that environmental auditing plays a critical role in protecting human health
and the environment by identifying, correcting, and ultimately preventing violations of
environmental regulations, [Hospital] and the United States Environmental Protection
Agency, Region 2 (the "Region") hereby agree that [Hospital] shall conduct a self-audit
program (the "Audit Program") for compliance with the regulations promulgated or
authorized by the United States Environmental Protection Agency ("EPA") set forth in
Section n below. The Agreement shall be governed by the terms of EPA's Policy
entitled "Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention
of Violations," 65 Federal Register 19618 (4/11/00, the "Policy"), except to the extent
that those terms are explicitly modified below.
II. SCOPE OF THE AUDIT
A. [Hospital] shall conduct an audit (the "Audit") of its compliance with the
regulations cited below in subsections 1 - 6 of Section n.B. The Audit will
encompass all (enter number) campuses of [Hospital], including any associated
off-site facilities such as (if applicable). Appendix A attached
hereto lists the campuses and other units associated with each covered campus
("Covered Campuses") that are covered by this agreement.
B. Under the Audit Program, [Hospital] will audit compliance with the following
federal regulatory programs:
1. Air Programs
Part 521 Section 21 Prevention of Significant Deterioration of Air Quality
Part 60 Standards of Performance for New Stationary Sources
Part 61 National Emission Standards for Hazardous Air Pollutants, Subpart M,
National Emission Standard for Asbestos
Part 62 Subpart HHH - Federal Plan Requirements for
Hospital/Medical/Infectious Waste Incinerators
Part 63 National Emission Standards for Hazardous Air Pollutants for Source
Categories (all applicable provisions)
1 The term "Part" refers to the subdivisions of the subchapters of Title 40 Code of Federal
Regulations ("C.F.R.").
Page 1 of 13
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Part 68 Chemical Accident Prevention Provisions
Part 70 State Operating Permit Programs
Part 82 Protection of Stratospheric Ozone
All applicable provisions of, and the Commonwealth of Puerto Rico
Implementation Plan regulations (pursuant to Section 110 of the Clean Air Act),
including the New Source Review regulations. Part 52, Subpart BBB.
2. Water Programs
Part 112 Oil Pollution Prevention
Part 122 EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System 40CFR Part 122.
Part 141 National Primary Drinking Water Regulations
Part 142 National Primary Drinking Water Regulations Implementation
Part 143 National Secondary Drinking Water Regulations
Part 144 Underground Injection Control ("UIC") Program
Part 145 State UIC Program Requirements
Part 146 UIC Program: Criteria and Standards
Part 147 State UIC Programs
Part 148 Hazardous Waste Injection Restrictions
Part 403 General Pretreatment Regulations for Existing and New Sources of
Pollution test
3. Pesticide Programs
Part 160 Good Laboratory Practice Standards
Part 162 State Registration of Pesticide Products
Part 170 Worker Protection Standard
Part 171 Certification of Pesticide Applicators
Part 172 Experimental Use Permits
4. Solid and Hazardous Wastes
Part 260 Hazardous Waste Management System: General
Part 261 Identification and Listing of Hazardous Waste
Part 262 Standards Applicable to Generators of Hazardous Waste
Part 263 Standards Applicable to Transporters of Hazardous Waste
Part 264 Standards for Owners and Operators of Hazardous Waste Treatment,
Storage, and Disposal Facilities
Part 265 Interim Status Standards for Owners and Operators of Hazardous
Waste Treatment, Storage, and Disposal Facilities
Part 266 Standards for the Management of Specific Hazardous Wastes and
Specific Types of Hazardous Waste Management Facilities
Part 268 Land Disposal Restrictions
Part 273 Standards for Universal Waste Management
Part 279 Standards for the Management of Used Oil
Page 2 of 13
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Part 280 Technical Standards and Corrective Action Requirements for Owners
and Operators of Underground Storage Tanks 40CFR 282.102.
5. Hazardous Substances and Chemicals, Environmental Response, Emergency
Planning, and Community Right-to-Know Programs
Part 302 Designation, Reportable Quantities, and Notification
Part 355 Emergency Planning and Notification
Part 370 Hazardous Chemical Reporting: Community Right-to-Know
Part 372 Toxic Chemical Release Reporting: Community Right-to-Know
6. Toxic Substances
Part 745 Lead-Based Paint Poisoning Prevention in Certain Residential
Structures
Part 761 Polychlorinated Biphenyls (PCBs) Manufacturing, Processing,
Distribution in Commerce, and Use Prohibitions
Part 763 Asbestos
C. The types of facilities and documents to be audited on the Covered Campuses are
set forth in Appendix B. The benefits of this Agreement shall extend to only
those facilities within the Covered Campuses that are audited.
III. DISCLOSURE
[Hospital] shall disclose all EPA-enforceable regulatory violations discovered during the
Audit. [Hospital] will voluntarily disclose these violations to the Region, in accordance
with the Policy, in written disclosure reports to be submitted in accordance with the
schedule set forth below in Section IV. Each such disclosure report shall contain, with
reference to each violation disclosed, the following additional information: the actions
selected by [Hospital] to correct the violation within 60 days, or as otherwise approved
pursuant to Section V below; the status of the corrective action; and the means taken by
[Hospital] to prevent recurrence of the violation. All disclosure reports will be submitted
by the scheduled date, and the Region agrees to waive the 21-day disclosure requirement
provided for in the Policy.
Once the action designed to correct a particular violation has been completed, and a
report submitted to the Region notifying it of the completion of the corrective action, no
further reporting on that violation, or the status of corrective action, is required. On
[Date of Termination of Agreement - usually sixty days after submittal of last
disclosure report], this Agreement shall terminate for all purposes, except that
[Hospital] shall remain obligated to complete the action necessary to correct any
disclosed violation, and to report to the Region in writing the completion of any
corrective action, previously unreported, within thirty days after such corrective action
has been completed.
Page 3 of 13
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This Audit Agreement does not cover any pre-Agreement activities, including regulatory
compliance issues discovered by [Hospital] or its environmental consultants) prior to
the effective date of this Agreement.
IV. SCHEDULE
A. Within 10 days of the effective date of this agreement, [Hospital] will identify
suitable personnel or consultants (where appropriate) to perform each of the six
regulatory program audits identified in Section n above and shall further identify
the applicable criteria pursuant to which each such regulatory program audit shall
be conducted. [Hospital] shall submit to EPA the audit protocols and audit
checklists for each of the six regulatory program audits, tailored to the Hospital,
and shall provide copies of these audit instruments to the Region. [Hospital] is
willing to share any materials it develops with other healthcare institutions and
the Region.
B. Within 30 days of the signing of the agreement, the Audit shall commence.
C. [Hospital] shall complete the regulatory audits required by the Sections listed in
this agreement, and shall submit disclosure reports to the Region, in accordance
with the Policy and the Agreement, identifying all EPA-enforceable violations
discovered during the course of these audits according to the schedule set forth in
Appendix C.
V. CORRECTIVE ACTION
[Hospital] shall correct each violation identified during the Audit, and shall take steps
necessary to prevent the recurrence of each such violation. Wherever possible, [Hospital]
shall correct any violations identified during the Audit within 60 days of discovery. In
those instances in which [Hospital] is unable to correct an identified violation within the
60-day deadline, it shall request an extension of time from the Region in writing and
provide a correction schedule, accompanied by a justification of the requested extension.
Any extension of the 60-day correction period shall be subject to the Region's approval.
Such approval will not be unreasonably withheld.
If [Hospital] discovers or otherwise becomes aware of a concern or concerns that may
present an imminent and substantial endangerment to human health or the environment,
and such concern(s) may exist at other [Hospital] campuses covered by this Agreement,
notwithstanding any other language herein to the contrary, [Hospital] agrees to address
such concern(s) at all covered campuses as expeditiously as possible and promptly take
such action as may be necessary at all covered campuses to protect human health and the
environment. [Hospital] shall notify EPA (initial notice may be by phone) of such
concern(s) within 24 hours of discovery or becoming aware of such concern(s) and shall
Page 4 of 13
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notify EPA in writing within five business days of such discovery of [Hospital's
proposed remedial action.
VI. CIVIL PENALTIES FOR DISCLOSED VIOLATIONS
Except as provided in Section n.D.8 of the Policy, the Region will not impose gravity-
based penalties for violations voluntarily discovered if they are timely disclosed and
corrected, and provided that the applicable provisions of the Policy and this Agreement
are met. The Region will consider the least expensive means for coming into compliance
for calculating potential economic benefit penalties for any disclosed violations, provided
that such methods comply with regulatory requirements.
VII. REGIONAL INSPECTIONS
The Region will assign a low priority for compliance inspections at the Covered
Campuses until after the completion of the Audit, except with respect to potential
violations of regulatory provisions, or at facilities, that are outside the scope of the Audit,
as defined in Section n above, or where: the Region has received a citizen's complaint;
the Region has reason to believe that circumstances exist that may pose a threat of actual
harm or an imminent and substantial endangerment to public health or the environment;
the Region has reason to believe that a criminal violation may, or has occurred; or where
[Hospital], pursuant to statute, has notified the National Response Center of a release.
Additionally, the Region retains the right to conduct during the Audit the inspections set
forth in subsections A and B immediately below:
A. Oversight Inspections: Where [Hospital] has reported a violation that requires
corrective action in the nature of a clean-up of contamination, the Region shall
have the right to conduct inspections at the corrective action site for the purpose
of overseeing or monitoring the clean-up, to assure correction of the violation.
No civil penalties shall be associated with or result from oversight inspections,
unless circumstances exist that may pose a threat of actual harm or an imminent
and substantial endangerment to public health or the environment.
B. Confirmation Inspections: Where [Hospital] has disclosed a violation, selected a
corrective action plan, and reported that the plan has been completed and the
violation cured, the Region shall have the right to inspect the relevant facility or
site to assure that the violation has in fact been corrected, or to require further
appropriate corrective action, if it has not. No civil penalties shall be associated
with or result from confirmation inspections, unless circumstances exist that may
pose a threat of actual harm or an imminent and substantial endangerment to
public health or the environment.
VIII. MISCELLANEOUS PROVISIONS
Page 5 of 13
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A. Notification and Certification of Disclosure Reports: [Hospital] designates as its
"responsible official," responsible for submitting disclosure reports to the Region,
the following individual:
Name of Responsible Official
Title
Name of Hospital
Address
City, State, Zip Code
Phone Number
Fax Number
Email Address
The responsible official shall certify that each disclosure report submitted to the
Region is true, accurate and complete in the form set forth in 40 C.F.R
§270.11(d).
[Hospital] designates as its "contact person," to be the recipient of all
communications from the Region concerning this Agreement, the following
individual:
Name of Contact Person
Title
Name of Hospital
Address
City, State, Zip Code
Phone Number
Fax Number
Email Address
The Region designates the following individual as its contact person:
Charles Zafonte
Multimedia Enforcement Coordinator
DECA-CAPSB
U.S. Environmental Protection Agency, Region 2
290 Broadway (21ST Floor)
New York, New York 10007-1866
Phone:(212)637-3515
Fax: (212)637-4086
zafonte. charles@,epa. gov
The parties may redesignate their contact person and responsible official in
writing.
Page 6 of 13
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B. Compliance With Law and Regulation: Neither the existence of this Agreement,
nor compliance with this Agreement relieves [Hospital] of its obligation of
continued compliance with the regulations covered by this Agreement, and all
other federal, state and local laws and regulations.
C. Reservation of Right: The Region reserves its right to proceed against
[Hospital] for all violations outside the scope of the Audit, and violations within
the scope of the Audit that were not timely reported or timely corrected. In any
enforcement proceeding, the Region may enforce the provision of 40 C.F.R.
allegedly violated, or its authorized or approved Commonwealth counterpart, if
said counterpart is federally enforceable as a matter of law.
D. Authority of Signatories: The signatories hereto represent that they have the
authority to bind the parties.
E. Modification: This Agreement may be modified by a writing signed by both
parties.
F. Coordination With the Commonwealth Environmental Agency: The Region has
informed the Puerto Rico Environmental Quality Board (PREQB) of this
Agreement and shall provide a copy to the PREQB. Nothing herein restricts
PREQB from acting as it deems appropriate.
G. Effective Date: This Agreement is effective on the date that it is signed by both
parties.
WE, THE UNDERSIGNED, HEREBY AGREE TO BE BOUND BY THIS AGREEMENT:
For [Hospital]:
Name of Responsible Official
Title
Address
City, State, Zip Code
Date:
For EPA-Region 2:
Page 7 of 13
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Jane M. Kenny, Regional Administrator
USEPA - Region 2
290 Broadway
New York, New York 10007
Date:
Page 8 of 13
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Appendix A
Covered Campuses and Off-Site Facilities Associated with Those Campuses
[List of Campuses and off-site facilities covered under the Audit Agreement goes here.]
Page 9 of 13
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Appendix B
SCOPE OF AUDIT PROGRAM
The following list provides the activities, areas, and/or shops that the review of the campus(es) must
cover. This list not meant to be all-inclusive. [Please select and include areas that exist at your
campus.]
Documents to Review (for the three years prior to the Program Period)
• Verify EPA identification numbers and permits
• Hazardous waste manifests
• Training records
• Land disposal restriction notifications
• Exception reports
• Lead disclosure statements in leases, or associated with leases of residential housing let
by the university in its capacity as a lessor, as defined in 40 C.F.R. § 745.103
• Contingency plans and annual reports (for contingency plans, only the current plan will
be reviewed)
• Required certifications
Facilities Operation and Maintenance
• Air conditioning/refrigeration service
• Appliance and equipment repair, including medical equipment
• Building cleaning and maintenance
• Building renovation and construction
• Cafeteria
• Chemical storage areas
• Drinking water treatment systems
• Fabrication shops
• Furniture repair
• Heating and power plants (e.g., boilers, emergency generators)
• House or architectural structure painting
• Landscaping operations
• Laundry
• PCB transformers and switches
• Pesticide storage facilities
• Resource recovery/incinerator facilities
• Waste disposal areas (landfills)
• Wastewater treatment facilities
• Waste treatment facilities such as autoclaves
Fleet Maintenance
-------
• Automotive, truck, and ambulance servicing areas
• Gasoline service stations
• Garages
Hazardous Waste / Tanks / Wells
• Aboveground and current operating underground storage tanks and their containment
areas/systems, and documentation concerning closures of regulated tanks previously
removed from service.
• Dry wells, septic systems, cesspools, floor drains, sink drains, and disposal wells.
• Facilities treating, storing or disposing of hazardous wastes.
• Hazardous waste satellite accumulation areas.
• Hazardous waste storage areas.
• Tanks that have been permanently or temporarily closed.
• Transformers and oil-containing electrical equipment (PCB and non-PCB).
• Universal waste storage areas.
Laboratories
• All clinical, pathology and dental laboratories
• All teaching and research laboratories with regular chemical use.
Patient Care
• Anesthesiology
• Chemotherapy
• Dentist's offices
• Doctor's offices
• Floor Pharmacies
• Histology
• Intensive Care Units
• Neonatal Areas
• Nursing Stations
• Operating Rooms
• Pathology, microbiology
• Patient's Rooms
• Patient treatment areas
• X-Ray/Radiology
Main Pharmacy
• Storage areas
• Outdated pharmaceuticals
Sterile Supply and Materials Management
• Autoclaving Units
• Ethylene Oxide (EtO) Units
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• Glutaraldehyde
• Use and disposal of disinfectants
Use and Disposal of Known Chemicals/Products of Concern
• Computers/monitors, circuit boards, and other lead-bearing electronics
• Ethanol and formaldehyde/ethanol solutions
• Fluorescent light bulbs and other types of lamps, including high-intensity discharge,
neon, mercury vapor, high pressure sodium, and metal halide lamps
• Formaldehyde/Formalin
• Mercury and Mercury-containing devices and products
• PVC-containing devices
• Xylene
• Batteries
• Solvents
• Photographic chemicals and scrap film
Other Services
• Athletic and training facilities
• Photo processing/publishing
• Morgue/Crematorium
• Animal care areas
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Appendix C
SCHEDULE OF DISCLOSURE REPORT SUBMISSIONS
[Insert a schedule of deadlines for submitting the disclosure reports. Provide details, as necessary, such
as, when audits will be done at each campus/location, the regulatory areas being audited (if not
all regulatory areas), and the names of campuses, buildings, or other location-specific info.]
Example:
Locati
Campi
Pharn
Physic
Print!
>n Progra
is A, e.g.:
acy e.g., R
al Plant
ihop
us to be Audited, if not Okte E
programs identified in
Section II.
RCRA, CWA
isclosure Report will be Submitted
-------
United States
Environmental Protection
Agency
Office of Water
(4203)
EPA 833-F-00-002
January 2000
Fact Sheet 2.0
Storm Water Phase II
Rule
Storm Water Phase II
Final Rule
Fact Sheet Series
Overview
1.0-Storm Water Phase II Final
Rule: An Overview
Small MS4 Program
2.0 - Small MS4 Storm Water
Program Overview
2.1 - Who's Covered? Designation
and Waivers of Regulated Small
MS4s
2.2 - Urbanized Areas: Definition
and Description
Minimum Control Measures
2.3 - Public Education and
Outreach
2.4 - Public Participation/
Involvement
2.5 - Illicit Discharge Detection
and Elimination
2.6 - Construction Site Runoff
Control
2.7 - Post-Construction Runoff
Control
2.8 - Pollution Prevention/Good
Housekeeping
2.9 - Permitting and Reporting:
The Process and Requirements
2.10 - Federal and State-Operated
MS4s: Program Implementation
Construction Program
3.0 - Construction Program
Overview
3.1 - Construction Rainfall
Erosivity Waiver
Industrial "No Exposure"
4.0 - Conditional No Exposure
Exclusion for Industrial Activity
Small MS4Storm Water Program
Overview
Polluted storm water runoff is often transported to municipal separate storm sewer systems
(MS4s) and ultimately discharged into local rivers and streams without treatment. EPA's
Storm Water Phase II Rule establishes an MS4 storm water management program that is
intended to improve the Nation's waterways by reducing the quantity of pollutants that storm
water picks up and carries into storm sewer systems during storm events. Common pollutants
include oil and grease from roadways, pesticides from lawns, sediment from construction sites,
and carelessly discarded trash, such as cigarette butts, paper wrappers, and plastic bottles.
When deposited into nearby waterways through MS4 discharges, these pollutants can impair
the waterways, thereby discouraging recreational use of the resource, contaminating drinking
water supplies, and interfering with the habitat for fish, other aquatic organisms, and wildlife.
In 1990, EPA promulgated rules establishing Phase I of the National Pollutant Discharge
Elimination System (NPDES) storm water program. The Phase I program for MS4s requires
operators of "medium" and "large" MS4s, that is, those that generally serve populations of
100,000 or greater, to implement a storm water management program as a means to control
polluted discharges from these MS4s. The Storm Water Phase II Rule extends coverage of the
NPDES storm water program to certain "small" MS4s but takes a slightly different approach to
how the storm water management program is developed and implemented.
What Is a Phase II Small MS4?
A small MS4 is any MS4 not already covered by the Phase I program as a medium or large
MS4. The Phase II Rule automatically covers on a nationwide basis all small MS4s
located in "urbanized areas" (UAs) as defined by the Bureau of the Census (unless waived by
the NPDES permitting authority), and on a case-by-case basis those small MS4s located outside
of UAs that the NPDES permitting authority designates. For more information on Phase II
small MS4 coverage, see Fact Sheets 2.1 and 2.2.
What Are the Phase II Small MS4 Program Requirements?
^perators of regulated small MS4s are required to design their programs to:
Q Reduce the discharge of pollutants to the "maximum extent practicable" (MEP);
Q Protect water quality; and
Q Satisfy the appropriate water quality requirements of the Clean Water Act.
Implementation of the MEP standard will typically require the development and
implementation of BMPs and the achievement of measurable goals to satisfy each of the six
minimum control measures.
The Phase II Rule defines a small MS4 storm water management program as a program
comprising six elements that, when implemented in concert, are expected to result in
significant reductions of pollutants discharged into receiving waterbodies.
-------
Fact Sheet 2.0 - An Overview of the Small MS4 Storm Water Program
Page 2
The six MS4 program elements, termed "minimum control
measures," are outlined below. For more information on each
of these required control measures, see Fact Sheets 2.3 - 2.8.
O Public Education and Outreach
Distributing educational materials and performing
outreach to inform citizens about the impacts polluted
storm water runoff discharges can have on water quality.
© Public Participation/Involvement
Providing opportunities for citizens to participate in
program development and implementation, including
effectively publicizing public hearings and/or
encouraging citizen representatives on a storm water
management panel.
© Illicit Discharge Detection and Elimination
Developing and implementing a plan to detect and
eliminate illicit discharges to the storm sewer system
(includes developing a system map and informing the
community about hazards associated with illegal
discharges and improper disposal of waste).
@ Construction Site Runoff Control
Developing, implementing, and enforcing an erosion and
sediment control program for construction activities that
disturb 1 or more acres of land (controls could include
silt fences and temporary storm water detention ponds).
© Post-Construction Runoff Control
Developing, implementing, and enforcing a program to
address discharges of post-construction storm water
runoff from new development and redevelopment areas.
Applicable controls could include preventative actions
such as protecting sensitive areas (e.g., wetlands) or the
use of structural BMPs such as grassed swales or porous
pavement.
© Pollution Prevention/Good Housekeeping
Developing and implementing a program with the goal of
preventing or reducing pollutant runoff from municipal
operations. The program must include municipal staff
training on pollution prevention measures and techniques
(e.g., regular street sweeping, reduction in the use of
pesticides or street salt, or frequent catch-basin cleaning).
What Information Must the NPDES Permit
Application Include?
The Phase II program for MS4s is designed to
accommodate a general permit approach using a Notice
of Intent (NOI) as the permit application. The operator of a
regulated small MS4 must include in its permit application,
or NOI, its chosen BMPs and measurable goals for each
minimum control measure. To help permittees identify the
most appropriate BMPs for their programs, EPA will issue a
"menu," of BMPs to serve as guidance. NPDES permitting
authorities can modify the EPA menu or develop their own
list. For more information on application requirements, see
Fact Sheet 2.9.
What Are the Implementation Options?
The rule identifies a number of implementation options for
regulated small MS4 operators. These include sharing
responsibility for program development with a nearby
regulated small MS4, taking advantage of existing local or
State programs, or participating in the implementation of an
existing Phase I MS4's storm water program as a co-permittee.
These options are intended to promote a regional approach to
storm water management coordinated on a watershed basis.
What Kind of Program Evaluation/Assessment Is
Required?
Permittees need to evaluate the effectiveness of their chosen
BMPs to determine whether the BMPs are reducing the
discharge of pollutants from their systems to the "maximum
extent practicable" and to determine if the BMP mix is
satisfying the water quality requirements of the Clean Water
Act. Permittees also are required to assess their progress
in achieving their program's measurable goals. While
monitoring is not required under the rule, the NPDES
permitting authority has the discretion to require monitoring
if deemed necessary. If there is an indication of a need for
improved controls, permittees can revise their mix of BMPs
to create a more effective program. For more information
on program evaluation/assessment, see Fact Sheet 2.9.
For Additional Information
Contact
^ U.S. EPA Office of Wastewater Management
• Phone: 202 260-5816
E-mail: SW2@epa.gov
Internet: www.epa.gov/owm/sw/phase2
Reference Documents
^ Storm Water Phase II Final Rule Fact Sheet Series
Internet: www.epa.gov/owm/sw/phase2
"sr Storm Water Phase II Final Rule (64 FR 68722)
Internet: www.epa.gov/owm/sw/phase2
Contact the U.S. EPA Water Resource Center
- Phone: 202260-7786
E-mail: center.water-resource@epa.gov
-------
vvEPA
United States
Environmental Protection
Agency
Office of Water
(4203)
EPA 833-F-00-003
January 2000
Fact Sheet 2.1
Storm Water Phase II
Final Rule
Storm Water Phase II
Final Rule
Fact Sheet Series
Overview
1.0-Storm Water Phase II Final
Rule: An Overview
Small MS4 Program
2.0 - Small MS4 Storm Water
Program Overview
2.1 - Who's Covered? Designation
and Waivers of Regulated Small
MS4s
2.2 - Urbanized Areas: Definition
and Description
Minimum Control Measures
2.3 - Public Education and
Outreach
2.4 - Public Participation/
Involvement
2.5 - Illicit Discharge Detection
and Elimination
2.6 - Construction Site Runoff
Control
2.7 - Post-Construction Runoff
Control
2.8 - Pollution Prevention/Good
Housekeeping
2.9 - Permitting and Reporting:
The Process and Requirements
2.10 - Federal and State-Operated
MS4s: Program Implementation
Construction Program
3.0 - Construction Program
Overview
3.1 - Construction Rainfall
Erosivity Waiver
Industrial "No Exposure"
4.0 - Conditional No Exposure
Exclusion for Industrial Activity
Who's Covered? Designation and
Waivers of Regulated Small MS4s
Who Is Affected by the Phase II Small MS4 Program?
The Storm Water Phase II Final Rule applies to operators of regulated small municipal
separate storm sewer systems (MS4s), which are designated based on the criteria discussed
in this fact sheet. In this fact sheet, the definition of an MS4 and the distinction between small,
medium, and large MS4s is reviewed. Conditions under which a small MS4 may be designated
as a regulated small MS4, as well as the conditions for a waiver from the Phase II program
requirements, are outlined. This fact sheet also attempts to clarify possible implementation
issues related to determining one's status as an operator of a regulated small MS4.
What Is a Municipal Separate Storm Sewer System (MS4)?
What constitutes an MS4 is often misinterpreted and misunderstood. The term MS4 does
not solely refer to municipally-owned storm sewer systems, but rather is a term of art with
a much broader application that can include, in addition to local jurisdictions, State departments
of transportation, universities, local sewer districts, hospitals, military bases, and prisons. An
MS4 also is not always just a system of underground pipes - it can include roads with drainage
systems, gutters, and ditches. The regulatory definition of an MS4 is provided below.
According to 40 CFR 122.26(b)(8), "municipal separate storm sewer
means a conveyance or system of conveyances (including roads with
drainage systems, municipal streets, catch basins, curbs, gutters, ditches,
man-made channels, or storm drains):
(i) Owned or operated by a State, city, town, borough, county,
parish, district, association, or other public body (created by or
pursuant to State law)...including special districts under State
law such as a sewer district, flood control district or drainage
district, or similar entity, or an Indian tribe or an authorized
Indian tribal organization, or a designated and approved
management agency under section 208 of the Clean Water Act
that discharges into waters of the United States.
(ii) Designed or used for collecting or conveying storm water;
(iii) Which is not a combined sewer; and
(iv) Which is not part of a Publicly Owned Treatment Works
(POTW) as defined at 40 CFR 122.2."
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Fact Sheet 2.1 - Who's Covered? Designation and Waivers of Regulated Small MS4s
Page 2
What Is a Small, Medium, or Large MS4?
Q EPA's NPDES (National Pollutant Discharge
Elimination System) storm water permitting program
labels MS4s as either "small," " medium," or "large"
for the purposes of regulation.
Q A small MS4 is any MS4 that is not already covered by
the Phase I storm water program. Small MS4s include
Federally-owned systems, such as military bases.
Q The Phase I storm water program covers medium
and large MS4s. Phase I MS4s were automatically
designated nationwide as medium MS4s if they were
located in an incorporated place or county with a
population between 100,000 - 249,999 or as large
MS4s if located in an incorporated place or county with
a population of 250,000 or greater. Many MS4s in
areas below 100,000 in population, however, have
been individually brought into the Phase I program by
NPDES permitting authorities. Such already regulated
MS4s do not have to develop a Phase II program.
Are All Small MS4s Covered by the Phase II
Final Rule?
No. The universe of small MS4s is quite large since it
includes every MS4 except for the approximately 900
medium and large MS4s already regulated under the Phase I
storm water program. Only a select sub-set of small MS4s,
referred to as regulated small MS4s, is covered by the
Phase II Final Rule, either through automatic nationwide
designation or designation on a case-by-case basis by the
NPDES permitting authority.
How Is A Small MS4 Designated as a Regulated
Small MS4?
Urbanized Areas
A
small MS4 can be designated by the permitting authority
as a regulated small MS4 in one of three ways:
O Automatic Nationwide Designation
The Phase II Final Rule requires nationwide coverage
of all operators of small MS4s that are located within
the boundaries of a Bureau of the Census-defined
"urbanized area" (UA) based on the latest decennial
Census. Once a small MS4 is designated into the
program based on the UA boundaries, it cannot be
waived from the program if in a subsequent UA
calculation the small MS4 is no longer within the UA
boundaries. An automatically designated small MS4
remains regulated unless, or until, it meets the criteria
for a waiver.
An urbanized area (UA) is a land area
comprising one or more places - central place(s)
- and the adjacent densely settled surrounding
area - urban fringe - that together have a
residential population of at least 50,000 and an
overall population density of at least 1,000 people
per square mile. It is a calculation used by the
Bureau of the Census to determine the
geographic boundaries of the most heavily
developed and dense urban areas.
Before the time of permit issuance (which must
be by December 9, 2002), UA calculations based
on the 2000 Census should be published. The
regulated universe then will be based on these new
calculations. For more information on UAs, see
Fact Sheet 2.2.
Q Preamble of the Phase II Final Rule:
Appendix 6
A listing of governmental entities that are located
either fully or partially within a UA according to
the 1990 Census can be found in Appendix 6 to the
Preamble. The list is a general geographic reference
intended to help operators of small MS4s determine
whether or not they are located in a UA and,
consequently, required to comply with the regulation;
it is not a list of all Phase II regulated MS4s. For
example, the list does not include small MS4
operators such as colleges and universities, Federal
prison complexes, and State highway departments
located within a UA. See Fact Sheet 2.2 for more
information on how to determine potential coverage
under the Phase II program. Appendix 6 can be
obtained from the EPA Office of Wastewater
Management (OWM) or downloaded from the
OWM web site.
Potential Designation by the NPDES Permitting
Authority - Required Evaluation
An operator of small MS4 located outside of a UA may
be designated as a regulated small MS4 if the NPDES
permitting authority determines that its discharges cause,
or have the potential to cause, an adverse impact on
water quality. The Phase II Final Rule requires the
NPDES permitting authority to develop a set of
designation criteria and apply them, at a minimum,
to all small MS4s located outside of a UA serving a
jurisdiction with a population of at least 10,000 and a
population density of at least 1,000 people/square mile.
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Fact Sheet 2.1 - Who's Covered? Designation and Waivers of Regulated Small MS4s
Page 3
Q Designation Criteria
EPA recommends that the NPDES permitting
authority use a balanced consideration of the
following designation criteria on a watershed or
other local basis:
• Discharge to sensitive waters;
• High population density;
• High growth or growth potential;
• Contiguity to a UA;
• Significant contributor of pollutants to
waters of the United States; and
• Ineffective protection of water quality
concerns by other programs.
Q Preamble of the Phase II Final Rule:
Appendix 7
A listing of governmental entities located outside of
a UA, that have a population of at least 10,000 and
a population density of at least 1,000 people per
square mile can be found in Appendix 7 to the
Preamble of the Phase II Final Rule. Similar to
Appendix 6, the list is a geographic reference only -
it is not a list of regulated entities. Operators of
small MS4s located within a listed area could be
examined by their NPDES permitting authority for
potential designation into the Phase II program.
Furthermore, the NPDES permitting authority
reserves the right to designate for regulation any
small MS4 that is contributing pollutants to waters
of the United States, whether or not its jurisdiction is
found in Appendix 7. Appendix 7 can be obtained
from the EPA Office of Wastewater Management or
downloaded from the OWM web site.
Q Deadline for Designation
The NPDES permitting authority is required to
designate small MS4s meeting the designation
criteria by December 9, 2002 or by December 8,
2004 if a watershed plan is in place.
Physically interconnected means that one MS4 is
connected to a second MS4 in such a way that it
allows for direct discharges into the second system.
Are Waivers from the Phase II Permit/Program
Requirements Possible?
Yes, two waiver options are available to operators of
automatically designated small MS4s if discharges do
not cause, or have the potential to cause, water quality
impairment.
The first applies where:
(1) the jurisdiction served by the system is less than
1,000 people;
(2) the system is not contributing substantially to the
pollutant loadings of a physically interconnected
regulated MS4; and
(3) if the small MS4 discharges any pollutants identified
as a cause of impairment of any water body to which
it discharges, storm water controls are not needed
based on wasteload allocations that are part of an
EPA approved or established "total maximum daily
load" (TMDL) that addresses the pollutant(s) of
concern.
TMDLs are water quality assessments that
determine the source or sources of pollutants of
concern for a particular waterbody, consider the
maximum amount of pollutants the waterbody
can assimilate, and then allocate to each source
a set level of pollutants that it is allowed to
discharge (i.e., a "wasteload allocation"). Small
MS4s that are not given a wasteload allocation
would meet the third criterion above.
Potential Designation by the NPDES Permitting
Authority - Physically Interconnected
Under the final rule, the NPDES permitting authority is
required to designate any small MS4 located outside of a
UA that contributes substantially to the pollutant loadings
of a physically interconnected MS4 regulated by the
NPDES storm water program. The final rule does not set
a deadline for designation of small MS4s meeting this
criterion.
Pollutants of Concern include biochemical
oxygen demand (BOD), sediment or a parameter
that addresses sediment (such as total suspended
solids, turbidity or siltation), pathogens, oil and
grease, and any pollutant that has been identified
as a cause of impairment in any water body to
which the MS4 discharges.
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Fact Sheet 2.1 - Who's Covered? Designation and Waivers of Regulated Small MS4s
Page 4
The second applies where:
(1) the jurisdiction served by the system is less than
10,000 people;
(2) an evaluation of all waters of the U.S. that receive a
discharge from the system shows that storm water
controls are not needed based on wasteload
allocations that are part of an EPA approved or
established TMDL that addresses the pollutant(s)
of concern or an equivalent analysis; and
(3) it is determined that future discharges from the small
MS4 do not have the potential to result in
exceedances of water quality standards.
The NPDES permitting authority is required to periodically
review any waivers granted to MS4 operators to determine
whether any information required for granting the waiver has
changed. Minimally, such a review needs to be conducted
once every five years.
Are There Allowances for Phasing-in Permit
Coverage?
Yes. Small MS4s serving a jurisdiction with a population
under 10,000 can be phased-in for permit coverage,
following establishment of a State watershed permitting
approach. NPDES permitting authorities that choose this
option must establish a schedule to phase-in permit coverage
annually for approximately 20 percent of all small MS4s that
qualify for such phased-in coverage. Where this option is
followed, all regulated small MS4s are required to have
permit coverage no later than March 8, 2007.
Can More than One MS4 in the Same Political
Jurisdiction Be Automatically Designated?
Yes. Since the final rule provides automatic coverage
of all small MS4s within a UA, the result would likely be
coverage of several governments and agencies with multiple,
perhaps overlapping, jurisdictions. For example, a city that is
located within a UA and operates its own small MS4 could be
designated alongside the State's department of transportation
(DOT) and the county's DOT if the State and county operate
roads that are within the borders of the city. All three
entities would be responsible for developing a storm water
management program for the portion of their respective
MS4s within the city limits. In such a case, the permittees
are strongly encouraged to work together to form a unified
storm water management program.
Who Is Responsible if the Small MS4 Operator
Lacks the Necessary Legal Authority?
Some regulated small MS4s may lack the necessary legal
authority to implement one or more of the required
minimum control measures that comprise the Phase II
storm water management program. For example, a local
government that is a small MS4 operator may be in a State
that does not have an enabling statute that allows local
regulatory control of construction site runoff into the sewer
system. Another example is a State DOT that may not have
the legal authority to require and enforce controls on illicit
discharges into its system. In these situations the small MS4
is encouraged to work with the neighboring regulated small
MS4s. As co-permittees, they could form a shared storm
water management program in which each permittee is
responsible for activities that are within their individual legal
authorities and abilities.
For Additional Information
Contact
ISP U.S. EPA Office of Wastewater Management
• Phone: 202 260-5816
E-mail: SW2@epa.gov
Internet: www.epa.gov/owm/sw/phase2
Reference Documents
ISP Storm Water Phase II Final Rule Fact Sheet Series
Internet: www.epa.gov/owm/sw/phase2
"sr Storm Water Phase II Final Rule (64 FR 68722)
Internet: www.epa.gov/owm/sw/phase2
Contact the U.S. EPA Water Resource Center
- Phone: 202260-7786
E-mail: center.water-resource@epa.gov
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V-/EPA
United States
Environmental Protection
Agency
Office of Water
(4203)
EPA 833-F-00-004
December 1999
Fact Sheet 2.2
Storm Water Phase II
Rule
Storm Water Phase II
Final Rule
Fact Sheet Series
Overview
1.0 - Storm Water Phase II Final
Rule: An Overview
Small MS4 Program
2.0 - Small MS4 Storm Water
Program Overview
2.1 - Who's Covered? Designation
and Waivers of Regulated Small
MS4s
2.2 - Urbanized Areas: Definition
and Description
Minimum Control Measures
2.3 - Public Education and
Outreach
2.4 - Public Participation/
Involvement
2.5 - Illicit Discharge Detection
and Elimination
2.6 - Construction Site Runoff
Control
2.7 - Post-Construction Runoff
Control
2.8 - Pollution Prevention/Good
Housekeeping
2.9 - Permitting and Reporting:
The Process and Requirements
2.10 - Federal and State-Operated
MS4s: Program Implementation
Construction Program
3.0 - Construction Program
Overview
3.1 - Construction Rainfall
Erosivity Waiver
Industrial "No Exposure"
4.0 - Conditional No Exposure
Exclusion for Industrial Activity
Urbanized Areas:
Definition and Description
A s discussed in Fact Sheet 2.1, Who's Covered? Designation and Waivers of Regulated
£\J5mall MS4s, the Phase II Final Rule covers all small municipal separate storm sewer
systems (MS4s) located within an "urbanized area" (UA). Based on the 1990 Census, there
are 405 UAs in the United States that cover 2 percent of total U.S. land area and contain
approximately 63 percent of the Nation's population. These numbers include Puerto Rico —
the only U.S. Territory with UAs.
UAs constitute the largest and most dense areas of settlement. UA calculations delineate
boundaries around these dense areas of settlement and, in doing so, identify the areas of
concentrated development. UA designations are used for several purposes in both the public
and private sectors. For example, the Federal Government has used UAs to calculate
allocations for transportation funding, and some planning agencies and development firms
use UA boundaries to help ascertain current, and predict future, growth areas.
What Is an Urbanized Area (UA)?
The Bureau of the Census determines UAs by applying a detailed set of published UA criteria
(see 55 FR 42592, October 22, 1990) to the latest decennial census data. Although the full
UA definition is complex, the Bureau of the Census' general definition of a UA, based on
population and population density, is provided below.
An urbanized area is a land area comprising one or more places —
central place(s) — and the adjacent densely settled surrounding area -
urban fringe — that together have a residential population of at least
50,000 and an overall population density of at least 1,000 people per
square mile.
The basic unit for delineating the UA boundary is the census block. Census blocks are based
on visible physical boundaries, such as the city block, when possible, or on invisible political
boundaries, when not. An urbanized area can comprise places, counties, Federal Indian
Reservations, and minor civil divisions (MCDs - towns and townships).
How Can Status as a Regulated Small MS4 Be Determined?
The drawing below (see Figure 1) is a simplified UA illustration that demonstrates the concept
of UAs in relation to the Phase II Final Rule. The "urbanized area" includes within its
boundaries incorporated places, a portion of a Federal Indian reservation, an entire MCD, a
portion of another MCD, and portions of two counties. Any and all operators of small MS4s
located within the boundaries of the UA are covered under the Phase II Final Rule, regardless of
political boundaries. Operators of small MS4s located outside of the UA are subject to potential
designation into the Phase IIMS4 program by the NPDES permitting authority.
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Fact Sheet 2.2 — Urbanized Areas: Definition and Description
Page 2
Operators of small MS4s can determine if they are located
within a UA, and therefore covered by the Phase II storm
water program, through the following two steps:
— STEP 1 —
Refer to a listing of incorporated places, MCDs, and counties
that are located entirely or partially within a UA. Such a
listing, based on the 1990 Census, can be found in Appendix
6 to the Preamble of the Phase II Final Rule; it does not
include governmental entities already permitted under
Phase I. If a small MS4 is located in a listed incorporated
place, MCD, or county, then the operator of the small MS4
should follow step (2) below. (Note: Appendix 6 can be
obtained from the EPA Office of Wastewater Management
(OWM) or downloaded from the OWM web site.)
— STEP 2 —
Some operators of small MS4s may find that they are located
within an entity listed in Appendix 6 but not know if their
systems are within the urbanized portion of the listed entity.
In such a case, they should contact one or more of the
following institutions for more detailed information on the
location of the UA boundary:
Q The State or NPDES Permitting Authority
(may be the State or the U.S. EPA Region)
Q
Storm Water Coordinators: The NPDES permitting
authority may be the State or the U.S. EPA Region.
The Storm Water Coordinators for each U.S. EPA
Region are listed in the For Additional Information
section in Fact Sheet 2.9. These regional contacts can
assist with UA information and provide the names of
State storm water contacts. Regional and State contact
information can also be obtained from OWM.
State Data Centers. Each State's Data Center receives
listings of all entities that are located in UAs, as well as
detailed maps and electronic files of UA boundaries.
The Bureau of the Census web site includes a list of
contact names and phone numbers for the data in each
State at www.census.gov/sdc/www.
State Planning/Economic/Transportation Agencies:
These agencies typically use UAs to assess current
development and forecast future growth trends and,
therefore, should have detailed UA information readily
available to help determine the UA boundaries in any
given area.
County or Regional Planning Commissions/
Boards
As with State agencies, these entities are likely to have
detailed UA data and maps to help determine UA
boundaries.
Figure 1
Central Place
( j Incorporated Place
/ \ Federal Indian Reservation (FIR)
Unincorporated "Urbanized
Area" Portion of a Town
(MCD) or County
Urbanized Area
Town or Township as a
functioning Minor Civil Division
(MCD). An MCD is the primary
subdivision of a County.
County
J
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Fact Sheet 2.2 — Urbanized Areas: Definition and Description
Page 3
Q The Bureau of the Census
Urbanized Areas Staff: 301457-1099
Web Site: www.census.gov
The site provides information on purchasing UA
maps and electronic files for use with computerized
mapping systems. Obtain free UA cartographic
boundary files (Arc/Info export format) for
Geographical Information System (GIS) use at:
www.census.gov:80/geo/www/cob/ua.html.
UA Maps: Detailed UA maps are available for
purchase with a $25 minimum order ($5 per map
sheet). Each map sheet measures 36 by 42 inches.
For prices and a listing of UAs, visit
www.census.gov/mp/www/geo/msgeo 12.html. Order
from the Department of Commerce, Bureau of the
Census (MS 1921), P.O. Box 277943, Atlanta, GA
30384-7943 (Phone: 301 457-4100; Toll-free fax:
1-888-249-7295).
Q U.S. EPA
EPA is modifying a web-based geographic program
called Enviromapper. This will allow MS4 operators
to enter a location and see a detailed map of the U A
boundary. Information about Enviromapper will be
available at www.epa.gov/owm/phase2.
How Will the Year 2000 Census Affect the
Determination of Status as a Regulated Small
MS4?
The listing of incorporated places, MCDs, and counties
located within UAs in the United States and Puerto Rico,
found in Appendix 6, is based on the 1990 Census. New
listings for UAs based on the 2000 Census are scheduled to
be available by July or August of 2001. Once the official
2000 Census listings are published by the Bureau of the
Census, operators of small MS4s located within the revised
boundaries of former 1990 UAs, or in any newly defined
2000 UAs, become regulated small MS4s and must develop a
storm water management program.
Any additional automatic designations of small MS4s based
on subsequent census years is governed by the Bureau of the
Census' definition of a UA in effect for that year and the UA
boundaries determined as a result of the definition.
Once a small MS4 is designated into the Phase II storm water
program based on the UA boundaries, it can not be waived
from the program if in a subsequent UA calculation the small
MS4 is no longer within the UA boundaries. An
automatically designated small MS4 will remain regulated
unless, or until, it meets the criteria for a waiver (see Fact
Sheet 2.1 for more information on the regulated small MS4
waiver option).
For Additional Information
Contact
^ U.S. EPA Office of Wastewater Management
• Phone: 202260-5816
E-mail: SW2@epa.gov
Internet: www.epa.gov/owm/sw/phase2
Reference Documents
^ Storm Water Phase II Final Rule Fact Sheet Series
• Internet: www.epa.gov/owm/sw/phase2
"sr Storm Water Phase II Final Rule (64 FR 68722)
• Internet: www.epa.gov/owm/sw/phase2
Contact the U.S. EPA Water Resource Center
- Phone: 202 260-7786
E-mail: center.water-resource@epa.gov
-------
vvEPA
United States
Environmental Protection
Agency
Office of Water
(4203)
EPA833-F-00-013
January 2000
Fact Sheet 3.0
Storm Water Phase II
Final Rule
Storm Water Phase II
Final Rule
Fact Sheet Series
Overview
1.0 - Storm Water Phase II
Proposed Rule: An Overview
Small MS4 Program
2.0 - Small MS4 Storm Water
Program Overview
2.1 - Who's Covered? Designation
and Waivers of Regulated Small
MS4s
2.2 - Urbanized Areas: Definition
and Description
Minimum Control Measures
2.3 - Public Education and
Outreach
2.4 - Public Participation/
Involvement
2.5 - Illicit Discharge Detection
and Elimination
2.6 - Construction Site Runoff
Control
2.7 - Post-Construction Runoff
Control
2.8 - Pollution Prevention/Good
Housekeeping
2.9 - Permitting and Reporting:
The Process and Requirements
2.10 - Federal and State-Operated
MS4s: Program Implementation
Construction Program
3.0 - Construction Program
Overview
3.1 - Construction Rainfall
Erosivity Waiver
Industrial "No Exposure"
4.0 - Conditional No Exposure
Exclusion for Industrial Activity
Small Construction Program
Overview
The 1972 amendments to the Federal Water Pollution Control Act, later referred to as the
Clean Water Act (CWA), prohibit the discharge of any pollutant to navigable waters of the
United States from a point source unless the discharge is authorized by a National Pollutant
Discharge Elimination System (NPDES) permit. Efforts to improve water quality under the
NPDES program traditionally have focused on reducing pollutants in industrial process
wastewater and municipal sewage treatment plant discharges. Over time, it has become evident
that more diffuse sources of water pollution, such as storm water runoff from construction sites,
are also significant contributors to water quality problems.
Sediment runoff rates from construction sites are typically 10 to 20 times greater than those
from agricultural lands, and 1,000 to 2,000 times greater than those of forest lands. During a
short period of time, construction activity can contribute more sediment to streams than can be
deposited over several decades, causing physical and biological harm to our Nation's waters.
In 1990, EPA promulgated rules establishing Phase I of the NPDES storm water program.
Phase I addresses, among other discharges, discharges from large construction activities
disturbing 5 acres or more of land. Phase II of the NPDES storm water program covers small
construction activities disturbing between 1 and 5 acres. Phase II became final on December 8,
1999 with small construction permit applications due by March 10, 2003 (specific compliance
dates will be set by the NPDES permitting authority in each State). This fact sheet outlines the
construction activities covered by Phase I and Phase II, including possible waiver options from
Phase II coverage, and the Phase II construction program requirements.
Who Is Covered Under the Phase I Rule?
Sites Five Acres and Greater
The Phase I NPDES storm water rule identifies eleven categories of industrial activity in the
definition of "storm water discharges associated with industrial activity" that must obtain an
NPDES permit. Category (x) of this definition is construction activity, commonly referred to
as "large" construction activity. Under category (x), the Phase I rule requires all operators of
construction activity disturbing 5 acres or greater of land to apply for an NPDES storm water
permit. Operators of sites disturbing less than 5 acres are also required to obtain a permit
if their activity is part of a "larger common plan of development or sale" with a planned
disturbance of 5 acres or greater. "Disturbance" refers to exposed soil resulting from activities
such as clearing, grading, and excavating. Construction activities can include road building,
construction of residential houses, office buildings, industrial sites, or demolition.
What Is Meant by a "Larger Common Plan of Development or Sale"?
As defined in EPA's NPDES storm water general permit for large construction activity, a
"larger common plan of development or sale" means a contiguous area where multiple
separate and distinct construction activities are occurring under one plan (e.g., the operator is
building on three half-acre lots in a 6-acre development). The "plan" in a common plan of
development or sale is broadly defined as any announcement or piece of documentation
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Fact Sheet 3.0 - Construction Program Overview
Page 2
(including a sign, public notice or hearing, sales pitch,
advertisement, drawing, permit application, zoning request,
computer design, etc.) or physical demarcation (including
boundary signs, lot stakes, surveyor markings, etc.) indicating
that construction activities may occur on a specific plot.
What Is the Definition of an "Operator" of a
Construction Site?
As defined in EPA's storm water general permit for large
construction activity, an "operator" is the party or parties
that has:
Q Operational control of construction project plans
and specifications, including the ability to make
modifications to those plans and specifications; or
Q Day-to-day operational control of those activities
that are necessary to ensure compliance with a
storm water pollution prevention plan (SWPPP) for
the site or other permit conditions (e.g., they are
authorized to direct workers at a site to carry out
activities required by the SWPPP or comply with
other permit conditions).
There may be more than one party at a site performing the
tasks related to "operational control" as defined above.
Depending on the site and the relationship between the
parties (e.g., owner, developer, contractor), there can either
be a single party acting as site operator and consequently be
responsible for obtaining permit coverage, or there can be
two or more operators, all obligated to seek permit coverage.
It is important to note that NPDES -authorized States may use
a different definition of "operator" than the one above.
How Is the Phase II Construction Rule Related
to the Phase I Construction Rule?
In 1992, the Ninth Circuit court remanded for further
proceedings portions of EPA's existing Phase I storm water
regulation related to the category (x) discharges from large
construction activity (NRDC v. EPA, 966 F.2d at 1292).
EPA responded to the court's decision by designating under
Phase II storm water discharges from construction activity
disturbing less than 5 acres as sources that should be
regulated to protect water quality. The Phase II Rule
designates these sources as "storm water discharges
associated with small construction activity," rather than
as another category under "storm water associated with
industrial activity."
Who Is Covered Under the Phase II
Construction Rule?
Sites Between One and Five Acres
The Storm Water Phase II Rule automatically designates, as
small construction activity under the NPDES storm water
permitting program, all operators of construction site
activities that result in a land disturbance of equal to or
greater than 1 and less than 5 acres.
Sites Less Than One Acre
Site activities disturbing less than 1 acre are also regulated as
small construction activity if they are part of a larger common
plan of development or sale with a planned disturbance of
equal to or greater than 1 acre and less than 5 acres, or if they
are designated by the NPDES permitting authority. The
NPDES permitting authority or EPA Region may designate
construction activities disturbing less than 1 acre based on
the potential for contribution to a violation of a water quality
standard or for significant contribution of pollutants to waters
of the United States.
Are Waivers Available for Operators of
Regulated Construction Activity?
Yes, but only for small, not large, construction activity.
Under the Phase II Rule, NPDES permitting authorities
have the option of providing a waiver from the requirements
to operators of small construction activity who certify to
either one of two conditions:
O Low predicted rainfall potential (i.e., activity occurs
during a negligible rainfall period), where the
rainfall erosivity factor ("R" in the Revised
Universal Soil Loss Equation [RUSLE]) is less than
5 during the period of construction activity; or
© A determination that storm water controls are not
necessary based on either:
(A) A "total maximum daily load" (TMDL) that
address the pollutant(s) of concern for
construction activities; OR
(B) An equivalent analysis that determines
allocations are not needed to protect water
quality based on consideration of instream
concentrations, expected growth in pollutant
concentrations from all sources, and a margin
of safety.
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Fact Sheet 3.0 - Construction Program Overview
Page 3
Pollutants of concern include sediment or a
parameter that addresses sediment (such as total
suspended solids, turbidity, or siltation) and any
other pollutant that has been identified as a cause of
The intent of the waiver provision is to waive only those sites
that are highly unlikely to have a negative effect on water
quality. Therefore, before applying for a waiver, operators
of small construction activity are encouraged to consider the
potential water quality impacts that may result from their
project and to carefully examine such factors as proximity to
water resources and sensitivity of receiving waters.
a. What is the Rainfall Erosivity Factor in
Waiver 0?
Waiver O uses the Rainfall Erosivity Factor to determine
whether the potential for polluted discharge is low
enough to justify a waiver from the requirements. It is one
of six variables used by the Revised Universal Soil Loss
Equation (RUSLE)—a predictive tool originally used to
measure soil loss from agricultural lands at various times
of the year on a regional basis—to predict soil loss from
construction sites. The Rainfall Erosivity Factor waiver is
time-sensitive and is dependent on when during the year a
construction activity takes place, how long it lasts, and
the expected rainfall and intensity during that time. For
information about the rainfall erosivity waiver, see Fact Sheet
3.1. Charts detailing the value of the Rainfall Erosivity
Factor by particular regions can be found in Chapter 2 of
the RUSLE user's guide, which can be downloaded at:
http ://www. epa.gov/owm/sw/phase2.
b. What is a "TMDL" in Waiver ©?
For impaired waters where technology-based controls
required by NPDES permits are not achieving State water
quality standards, the CWA requires implementation of the
TMDL process. The TMDL process establishes the
maximum amount of pollutants a waterbody can assimilate
before water quality is impaired, then requires that this
maximum level not be exceeded.
A TMDL is done for each pollutant that is found to be
contributing to the impairment of a waterbody or a segment
of a waterbody. To allow a waiver for construction activities,
a TMDL would need to address sediment, or a parameter
that addresses sediment such as total suspended solids,
turbidity, or siltation. Additional TMDLs addressing
common pollutants from construction sites such as nitrogen,
phosphorus, and oil and grease also may be necessary to
ensure water quality protection and allow a waiver from the
NPDES storm water program.
A TMDL assessment determines the source or sources of a
pollutant of concern, considers the maximum allowable level
of that pollutant for the waterbody, then allocates to each
source or category of sources a set level of the pollutant that
it is allowed to discharge into the waterbody. Allocations to
point sources are called wasteload allocations.
How Would an Operator Qualify for, and Certify
to, Waiver @?
EPA expects that when TMDLs, or equivalent analyses
are completed, there may be a determination that certain
classes of sources, such as small construction activity, would
not have to control their contribution of pollutants of
concern to the waterbody in order for the waterbody to be in
attainment with water quality standards (i.e., these sources
were not assigned wasteload allocations). In such a case, to
qualify for waiver ©, the operator of the construction site
would need to certify that its construction activity will take
place, and the storm water discharges will occur, within the
area covered either by the TMDLs or equivalent analysis. A
certification form would likely be provided by the NPDES
permitting authority for this purpose.
What Does the Phase II Construction Program
Require?
The Phase II Final Rule requires operators of Phase II
small construction sites, nationally, to obtain an NPDES
permit and implement practices to minimize pollutant runoff.
It is important to note that, locally, these same sites also may
be covered by State, Tribal, or local construction runoff
control programs (see Fact Sheets 2.6 and 2.7 for information
on the Phase II small MS4's construction program). For
the Phase II small construction program, EPA has taken an
approach similar to Phase I where the program requirements
are not fully defined in the rule but rather in the NPDES
permit issued by the NPDES permitting authority.
EPA recommends that the NPDES permitting authorities use
their existing Phase I large construction general permits as a
guide to developing their Phase II small construction permits.
In doing so, the Phase II requirements would be similar to the
three general Phase I requirements summarized below.
Q Submission of a Notice of Intent (NOI) that
includes general information and a certification
that the activity will not impact endangered or
threatened species. This certification is unique to
EPA's NOI and is not a requirement of most
NPDES-delegated State's NOIs;
Q The development and implementation of a Storm
Water Pollution Prevention Plan (SWPPP) with
appropriate BMPs to minimize the discharge of
pollutants from the site; and
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Fact Sheet 3.0 - Construction Program Overview
Page 4
Q Submission of a Notice of Termination (NOT)
when final stabilization of the site has been
achieved as defined in the permit or when another
operator has assumed control of the site.
Can the Permitting Authority Reference a
Qualifying Erosion and Sediment Control
Program in NPDES Construction Permits?
Yes. The Phase II Rule allows the NPDES permitting
authority to include in its NPDES permits for large and
for small construction activity conditions that incorporate by
reference qualifying State, Tribal, or local erosion and
sediment control program requirements. A qualifying
program must include the following requirements:
Q Requirements for construction site operators to
implement appropriate erosion and sediment control
best management practices;
Q Requirements for construction site operators to
control waste such as discarded building materials,
concrete truck washout, chemicals, litter, and
sanitary waste that may cause adverse impacts to
water quality;
Q Requirements for construction site operators to
develop and implement a storm water pollution
prevention plan; and
Q Requirements to submit a site plan for review that
incorporates consideration of potential water quality
impacts.
In addition to the four elements above, a qualifying program
for large construction activities must also include any
additional requirements necessary to achieve the applicable
technology-based standards of "Best Available Technology"
(BAT) and "Best Conventional Technology" (BCT) based
on the best professional judgment of the permit writer.
Should a State, Tribal, or local program include one or more,
but not all, of the elements listed above, the permitting
authority can reference the program in the permit, provided it
also lists the missing element(s) as a condition in the permit.
What are Some Recommended BMPs for Small
Construction Sites?
The approach and BMPs used for controlling pollutants in
storm water discharges from small construction sites may
vary from those used for large sites since their characteristics
can differ in many ways. For example, operators of small
sites may have more limited access to qualified design
personnel and technical information. Also, small sites may
have less space for installing and maintaining certain BMPs.
As is the case with all construction sites, erosion and
sediment control at small construction sites is best
accomplished with proper planning, installation, and
maintenance of controls. The following practices have
shown to be efficient, cost effective, and versatile for small
construction site operators to implement. The practices are
divided into two categories: non-structural and structural.
Q Non-Structural BMPs
• Minimizing Disturbance
Preserving Natural Vegetation
Good Housekeeping
Q Structural BMPs
Erosion Controls
Mulch
Grass
Stockpile Covers
Sediment Controls
Silt Fence
• Inlet Protection
Check Dams
Stabilized Construction Entrances
Sediment Traps
Most erosion and sediment controls require regular
maintenance to operate correctly. Accumulated sediments
should be removed frequently and materials should be
checked periodically for wear. Regular inspections by
qualified personnel, which can allow problem areas to be
addressed, should be performed after major rain events.
-------
Fact Sheet 3.0 - Construction Program Overview
Page 5
For Additional Information
Contact
^ U.S. EPA Office of Wastewater Management
• Phone: 202 260-5816
E-mail: SW2@epa.gov
Internet: www.epa.gov/owm/sw/phase2
"^ Your local soil conservation district office. They can
provide assistance with RUSLE and other conservation
related issues.
A list of conservation district contacts is available
at: www.nacdnet.org/resources/cdsonweb.html
Reference Documents
rap Storm Water Phase II Final Rule Fact Sheet Series
Internet: www.epa.gov/owm/sw/phase2
rap Storm Water Phase II Final Rule (64 FR 68722)
Internet: www.epa.gov/owm/sw/phase2
Contact the U.S. EPA Water Resource Center
- Phone: 202260-7786
E-mail: center.water-resource@epa.gov
raf Agricultural Handbook Number 703, Predicting Soil
Erosion by Water: A Guide to Conservation Planning
With the Revised Universal Soil Loss Equation
(RUSLE), Chapter 2, pp. 21-64, January 1997.
Internet: www.epa.gov/owm/sw/phase2
rar Guidance for Water Quality Based Decisions: The
TMDL Process. April 1991. U.S. EPA Office of
Water. EPA 440/4-91-001.
Internet: www.epa.gov/OWOW/tmdl
rar NPDES General Permit for Storm Water Discharges
from Construction Activities (63 FR 7857).
Internet: www.epa.gov/owm/sw
Contact the U.S. EPA Water Resource Center
Phone: 202260-7786
E-mail: center.water-resource@epa.gov
-------
&EPA
United States
Environmental Protection
Agency
Office of Water
(4203)
EPA833-F-00-014
January 2001
Fact Sheet 3.1
Storm Water Phase
Final Rule
Storm Water Phase II
Final Rule
Fact Sheet Series
Overview
1.0-Storm Water Phase II
Proposed Rule Overview
Small MS4 Program
2.0 - Small MS4 Storm Water
Program Overview
2.1 - Who's Covered? Designation
and Waivers of Regulated Small
MS4s
2.2 - Urbanized Areas: Definition
and Description
Minimum Control Measures
2.3 - Public Education and
Outreach
2.4 - Public Participation/
Involvement
2.5 - Illicit Discharge Detection
and Elimination
2.6 - Construction Site Runoff
Control
2.7 - Post-Construction Runoff
Control
2.8 - Pollution Prevention/Good
Housekeeping
2.9 - Permitting and Reporting:
The Process and Requirements
2.10-Federaland State-
Operated MS4s: Program
Implementation
Construction Program
3.0 - Construction Program
Overview
3.1 -Construction Rainfall
Erosivity Waiver
Industrial" No Exposure"
4.0 - Conditional No Exposure
Exclusion for Industrial Activity
Construction Rainfall Erosivity
Waiver
The 1972 amendments to the Federal Water Pollution Control Act, later referred to as the Clean
Water Act (CWA), prohibit the discharge of any pollutant to navigable waters of the United States
unless the discharge is authorized by a National Pollutant Discharge Elimination System (NPDES)
permit. Because construction site storm water runoff can contribute significantly to water quality
problems, the Phase I Storm Water Rule imposed a requirement that all construction sites with a
planned land disturbance of 5 acres or more obtain an NPDES permit and implement storm water
runoff control plans. Phase II extends the requirements of the storm water program to sites of
between 1 and 5 acres. The Rainfall erosivity waiver, along with the water quality waiver, allows
permitting authorities to waive those sites that do not have adverse water quality impacts.
What is Erosivity?
Erosivity is the term used to describe the potential for soil to wash off disturbed, devegetated earth
into waterways during storms. The potential for erosion is in part determined by the soil type
and geology of the site. For instance, dense, clay-like soils on a glacial plain will erode less readily
when it rains than will sandy soils on the side of a hill. Another important factor is the amount and
force of precipitation expected during the time the earth will be exposed. While it is impossible to
predict the weather several months in advance of construction, for many areas of the country, there
are definite optimal periods, such as a dry season when rain tends to fall less frequently and with less
force. When feasible, this is the time to disturb the earth, so that the site is stabilized by the time the
seasonal wet weather returns. There are many other important factors to consider in determining
erosivity, such as freeze/thaw cycles and snow pack.
How Is Site Erosivity Determined?
The method for determining if a site qualifies for the erosivity waiver is based on the Universal Soil
Loss Equation (USLE) developed by the U.S. Department of Agriculture (USDA) in the 1950s to
help farmers conserve their valuable topsoil. The USLE has been updated to the Revised USLE
(RUSLE). Using a computer model supported by decades worth of soil and rainfall data, USDA
established estimates of annual erosivity values (R) for sites throughout the country. These R factors
are used as surrogate measures of the impact that rainfall had on erosion from a particular site. They
have been mapped using isoerodent contours, as shown in Figures 2 through 5.
USDA developed the Erosivity Index Table (El Table, provided here in Table 1), to show how the
annual erosivity factor is distributed throughout the year in two-week increments. Table 1 is based on
120 rainfall distribution zones for the continental U.S. Detailed instructions for calculating a project
R Factor are provided later in this fact sheet.
The Storm Water Phase II rule allows permitting authorities to waive NPDES requirements for small
construction sites if the value of the rainfall erosivity factor is less than 5 during the period of
construction activity (see § 122.26(b)(15)(i)(A)). Note that the permitting authority has the option to
not allow waivers for small construction activity. If the permitting authority in a State chooses to use
the rainfall erosivity waiver, it will not become effective until permits are required from small
construction activity.
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
Page 2
If the R Factor for the period of construction calculates to 5 or
lower, and the permitting authority allows the use of the waiver,
the site owner may apply for a waiver under the low rainfall
erosivity provision of the applicable NPDES Construction
General Permit. When applying, owners are encouraged to
consider other site-specific factors, such as proximity to water
resources and the sensitivity of receiving waters to sedimentation
impacts. The small construction operator must certify to the
permitting authority that the construction activity will take place
during a period when the rainfall erosivity factor is less than 5.
The start and end dates used for the construction activity will be
the initial date of disturbance and the anticipated date when the
site will have achieved final stabilization as defined by the
permit. If the construction continues beyond this period, the
operator will need to recalculate the El for the site based on this
new ending date (but keeping the old start date) and either
resubmit the certification form or apply for NPDES permit
coverage.
What Other Factors Can Affect Waiver Availability
and Eligibility?
EPA has established the R Factor of 5 or lower as the criteria
for determining waiver eligibility. However, since the intent
is to waive only those construction activities that will not
adversely impact water quality, State and Tribal permitting
authorities have considerable discretion in determining where,
when, and how to offer it. They can establish an R Factor
threshold lower than 5, or they can suspend the waiver within an
area where watersheds are known to be heavily impacted by, or
sensitive to, sedimentation. They can also suspend the waiver
during certain periods of the year. They may opt not to offer the
waiver at all. NOTE: This waiver is not available to sites that
will disturb more than 5 acres of land (large construction).
What if My Site Is Not Eligible?
If your site is not eligible for a waiver, you must submit a Notice
of Intent under the NPDES General Permit, and comply with
its requirements. These requirements are described in more
detail in Storm Water Phase II Fact Sheet 3.0.
How Do I Compute the R Factor for My Project?
1. Estimate the construction start date. This is the day you
expect to begin disturbing soils, including grubbing,
stockpiling, excavating, and grading activities. Pick the 15-
day period for your start date (e.g., June 1-15.)
2. Estimate the day you expect to have a permanent vegetative
cover of at least 70%, or as defined by your permitting
authority, over all previous disturbed areas. Round to the
nearest 15-day period.
3. Refer to Figure 1 to find your Erosivity Index (El) Zone
based on your geographic location.
4. Refer to Table 1, the Erosivity Index (El) Table. Find the
number of your El Zone in the left column. Locate the El
values for the 15-day periods that correspond to the project
start and end periods you identified in Steps 1 and 2.
Subtract the start value from the end value to find the % El
for your site. The maximum annual El value for a project is
100%.
5. Refer to the appropriate Isoerodent Map (Figures 2 through
5). Interpolate the annual isoerodent value for your area.
This is the annual R Factor for your site.
6. Multiply the percent value obtained in Step 4 by the annual
isoerodent value obtained in Step 5. This is the R Factor for
your scheduled project.
Examples
1. Construction started and completed in one
calendar year.
Find the R value of a construction site in Denver, Colorado.
Assume the site will be disturbed from March 1 to May 15.
The El distribution zone is 84 (Figure 1). Referring to Table 1,
the project period will span from March 1 to May 15. The
difference in values between these two periods is 4.7 % (4.9-0.2
=4.7). Since the annual erosion index for this location is about
45 (interpolated from Figure 2), the R Factor for the scheduled
construction project is 4.7% of 45, or 2.1.
Because 2.1 is less than 5, the operator of this site would be
able to seek a waiver under the low rainfall erosivity provision.
2. Construction spanning two calendar years.
Find the R value for a construction site in Pittsburgh,
Pennsylvania. Assume the site will be disturbed from August 1
to April 15.
The El distribution zone is 111 (Figure 1). Referring to Table
1, the project will span from August 1 to April 15. The
difference in values between August 1 and December 30 is 35%
(100- 65.0 = 35.0). The difference between January 1 and April
15 is 8%. The total percentage El for this project is 43% (35 +
8). Since the annual erosion index for this location is 112
(interpolated from Figure 2), the R Factor for the scheduled
construction is 43% of 112, or 48.
Since 48 is greater than 5, the operator of this site would not be
able to seek a waiver under the low rainfall erosivity provision.
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
Page 3
Can I Use A Personal Computer to Calculate the R
Factor?
The computer program used by USDA to develop the current R
Factor maps and table is called the Revised Universal Soil
Loss Equation, or RUSLE. The current version of RUSLE (v.
1.60) will calculate the R factor for the entire year for a limited
number of cities in the U.S., but does not allow the R factor to be
easily adjusted based on a shorter period of construction. If you
are interested in using RUSLE; Version 1.06 for Mined Lands,
Construction Sites, and Reclaimed Lands, is downloadable free of
charge from the Internet at http://www.sedlab.olemiss.edu/rusle.
Where Can I Get Help?
A copy of "Chapter 2, Rainfall-Runoff Erosivity Factor (R)"
from the USDA Handbook 703 - Predicting Soil Erosion by
Water: A Guide to Conservation Planning With the Revised
Universal Soil Loss Equation (RUSLE), January 1997, is
available on EPA's web site at http://www.epa.gov/owm/sw/.
Your local soil conservation district office can provide
assistance with R Factors and other conservation-related
issues. To find the office nearest you, look in the
government section of the phone book under soil
conservation district, conservation district, natural resource
conservation district, etc.
For Additional Information
Reference Documents
Storm Water Phase II Final Rule Fact Sheet Series
Internet: www.epa. gov/owm/sw/phase2
• Storm Water Phase II Final Rule(64 FR 68722)
Internet: www.epa. gov/owm/sw/phase2
Contact the U.S. EPA Water Resource Center
S Phone: 202 260-7786
S E-mail: center.water-resource(@,epa.gov
• Agricultural Handbook Number 703, Predicting Soil
Erosion by Water: A Guide to Conservation Planning
With the Revised Universal Soil Loss Equation
(RUSLE), Chapter 2, pp. 21-64, January 1997.
Internet: www.epa.gov/owm/sw/phase2
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
Page 4
Figure 1. Erosivity Index Zone Map
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
Page 5
Figure 2. Isoerodent Map of the Eastern U.S.
Note: Units for all maps on this page are are hundreds
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
Page 6
Figure 3. Isoerodent Map of the Western U.S.
Note: Units for all maps on this page are are hundreds
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
Page 7
Figure 4. Isoerodent Map of California
Note: Units for all maps on this page are are hundreds ft«tonf«in(ac«h«yr)"
-------
Fact Sheet 3.1 - Construction Rainfall Erosivity Waiver
PageS
Figure 5. Isoerodent Map of Oregon and Washington
Note: Units for all maps on this page are are hundreds
-------
Table 1. Erosivity Index Table
EI as a percentage of Average Annual R Value Computed for Geographic Areas Shown in Figure 1
El#
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Jan
1-15
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Jan
16-31
4.3
4.3
7.4
3.9
2.3
0.0
0.0
0.0
0.8
0.3
5.4
3.5
0.0
0.7
0.0
0.0
0.0
0.0
1.0
9.8
7.5
1.2
7.9
12.2
9.8
2.0
0.0
0.0
0.6
0.0
Feb
1-15
8.3
8.3
13.8
7.9
3.6
0.0
0.0
0.0
3.1
0.5
11.3
7.8
0.0
1.8
0.0
0.0
0.0
0.0
2.6
18.5
13.6
1.6
15.0
23.6
20.8
5.4
0.0
0.0
0.7
0.0
Feb
16-29
12.8
12.8
20.9
12.6
4.7
0.5
0.0
0.0
4.7
0.9
18.8
14.0
1.8
3.3
0.5
0.5
0.7
0.6
7.4
25.4
18.1
1.6
20.9
33.0
30.2
9.8
1.0
0.0
0.7
0.0
Mar
1-15
17.3
17.3
26.5
17.4
6.0
2.0
0.0
0.0
7.4
2.0
26.3
21.1
7.2
6.9
2.0
2.0
2.8
2.5
16.4
30.2
21.1
1.6
25.7
39.7
37.6
15.6
4.0
0.2
0.7
0.0
Mar
16-31
21.6
21.6
31.8
21.6
7.7
4.1
1.2
0.9
11.7
4.3
33.2
27.4
11.9
16.5
4.4
5.5
6.1
6.2
23.5
35.6
24.4
1.6
31.1
47.1
45.8
21.5
5.9
0.5
1.5
0.2
Apr
1-15
25.1
25.1
35.3
25.2
10.7
8.1
4.9
3.6
17.8
9.2
37.4
31.5
16.7
26.6
8.7
12.3
10.7
12.4
28.0
38.9
27.0
1.6
35.7
51.7
50.6
24.7
8.0
1.5
3.9
0.8
Apr
16-30
28.0
28.0
38.5
28.7
13.9
12.6
8.5
7.8
22.5
13.1
40.7
35.0
19.7
29.9
12.0
16.2
12.9
16.4
31.0
41.5
29.4
2.2
40.2
55.9
54.4
26.6
11.1
3.3
6.0
2.8
May
1-15
30.9
30.9
40.2
31.9
17.8
17.6
13.9
15.0
27.0
18.0
42.5
37.3
24.0
32.0
16.6
20.9
16.1
20.2
33.5
42.9
31.7
3.9
43.2
57.7
56.0
27.4
13.0
7.2
10.5
7.9
May
16-31
34.9
34.9
41.6
35.1
21.2
21.6
19.0
20.2
31.4
22.7
44.3
39.8
31.2
35.4
21.4
26.4
21.9
23.9
37.0
44.0
34.6
4.6
46.2
58.6
56.8
28.0
14.0
11.9
17.9
14.2
Jun
1-15
39.1
39.1
42.5
38.2
24.5
25.5
26.1
27.4
36.0
29.2
45.4
41.9
42.4
40.2
29.7
35.2
32.8
29.3
41.7
45.2
37.3
6.4
47.7
58.9
57.1
28.7
14.6
17.7
28.8
24.7
Jun
16-30
42.6
42.6
43.6
42.0
28.1
29.6
35.4
38.1
41.6
39.5
46.5
44.3
55.0
45.1
44.5
48.1
45.9
37.7
48.1
48.2
39.6
14.2
48.8
59.1
57.1
29.8
15.3
21.4
36.6
35.6
Jul
1-15
45.4
45.4
44.5
44.9
31.1
34.5
43.9
49.8
46.4
46.3
47.1
45.6
60.0
51.9
56.0
58.1
55.5
45.6
51.1
50.8
41.6
32.8
49.4
59.1
57.2
32.5
17.0
27.0
43.8
45.4
Jul
16-31
48.2
48.2
45.1
46.7
33.1
40.0
48.8
57.9
50.1
48.8
47.4
46.3
60.8
61.1
60.8
63.1
60.3
49.8
52.0
51.7
43.4
47.2
49.9
59.2
57.6
36.6
23.2
37.1
51.5
52.2
Aug
1-15
50.8
50.8
45.7
48.2
35.3
45.7
53.9
65.0
53.4
51.1
47.8
46.8
61.2
67.5
63.9
66.5
64.0
53.3
52.5
52.5
45.4
58.8
50.7
59.2
58.5
44.9
39.1
51.4
59.3
58.7
Aug
16-31
53.0
53.0
46.4
50.1
38.2
50.7
64.5
75.6
57.4
57.2
48.3
47.9
62.6
70.7
69.1
71.9
71.2
58.4
53.6
54.6
48.1
69.1
51.8
59.3
59.8
55.4
60.0
62.3
68.0
68.5
Sep
1-15
56.0
56.0
47.7
53.1
43.2
55.6
73.4
82.7
61.7
64.4
49.4
50.0
65.3
72.8
74.5
77.0
77.2
64.3
55.7
57.4
51.3
76.0
54.1
59.5
62.2
65.7
76.3
70.6
74.8
77.6
Sep
16-31
60.8
60.8
49.4
56.6
48.7
60.2
77.5
86.8
64.9
67.7
50.7
52.9
67.6
75.4
79.1
81.6
80.3
69.0
57.6
58.5
53.3
82.0
57.7
60.0
65.3
72.6
86.1
78.8
80.3
84.5
Oct
1-15
66.8
66.8
52.8
62.2
57.3
66.5
80.4
89.4
69.7
71.1
53.6
57.9
71.6
78.6
83.1
85.1
83.1
75.0
61.1
60.1
56.6
87.1
62.8
61.4
67.5
77.8
89.7
84.6
84.3
88.9
Oct
16-31
71.0
71.0
57.0
67.9
67.8
75.5
84.8
93.4
79.0
77.2
57.5
62.3
76.1
81.9
87.0
88.4
87.7
86.6
65.8
63.2
62.4
96.7
65.9
63.0
68.2
84.4
90.4
90.6
88.8
93.7
Nov
1-15
75.7
75.7
64.5
75.2
77.9
85.6
89.9
96.3
89.6
85.1
65.5
69.3
83.1
86.4
90.9
91.5
92.6
93.9
74.7
69.6
72.4
99.9
70.1
66.5
69.4
89.5
90.9
94.4
92.7
96.2
Nov
16-31
82.0
82.0
73.1
83.5
86.0
95.9
96.6
99.1
97.4
92.5
76.2
81.3
93.3
93.6
96.6
96.3
97.2
96.6
88.0
76.7
81.3
99.9
77.3
71.8
74.8
93.9
93.1
97.9
98.0
97.6
Dec
1-15
89.1
89.1
83.3
90.5
91.3
99.5
99.2
100.0
100.0
96.5
87.4
91.5
98.2
97.7
99.1
98.7
99.1
98.0
95.8
85.4
88.9
99.9
86.8
81.3
86.6
96.5
96.6
99.3
99.8
98.3
Dec
16-31
95.2
95.2
92.3
96.0
96.9
99.9
99.7
100.0
100.0
99.0
94.8
96.7
99.6
99.3
99.8
99.6
99.8
100.0
98.7
92.4
94.7
99.9
93.5
89.6
93.0
98.4
99.1
100.0
99.9
99.6
-------
Table 1. Erosivity Index Table (cont.)
El#
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
Jan
1-15
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Jan
16-31
0
0.1
0
0
0
0
0
0
0
0
0.1
0
0
1.7
0.2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Feb
1-15
0
0.1
0
0
0
0
0
0
0
0
0.2
0
0
2.3
0.2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Feb
16-29
0
0.1
0
0
0
0
0
1.1
0
0
0.2
0
0
2.4
0.3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Mar
1-15
0
0.1
0
0
0
0
0
4.3
0
0
0.2
0
0
2.4
0.3
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Mar
16-31
0.2
0.6
0.6
1.8
2.5
0.9
0
7.2
1.6
1.5
0.2
0
0
2.4
0.4
0
0
0
0
0.1
0.3
0
0
0.2
0
0
0
0.2
0
0
Apr
1-15
1
2.2
2.3
7.3
10.2
3.4
0
11
6.5
6.2
0.2
0
0
2.4
0.6
0
0
0
0
0.4
1
0
0
0.7
0
0
0.1
0.9
0
0
Apr
16-30
3.5
4.3
4.2
10.7
15.9
6.7
1
13.9
11
10.1
0.4
0.2
0.1
2.7
0.8
0.6
0.4
0
0.7
2.4
3.1
0.6
0.8
2.4
1.3
1.3
1
2.9
2.2
0.4
May
1-15
9.9
9
8.8
15.5
22.2
12.7
3.9
17.9
17.8
16.3
1.1
0.9
0.4
3.5
1.4
2.6
1.6
0
2.7
8.2
8.7
2.5
3
7.2
5.4
5.1
3.5
8
8.9
1.5
May
16-31
15.7
14.2
16.1
22
27.9
18.5
9.1
22.3
24.7
23.3
6.8
5.2
2.7
7.6
3.7
7.5
5.8
2
8.3
13.7
18.8
6.8
9.5
14.7
13.3
11.4
9.2
13.2
15.6
4
Jun
1-15
26.4
23.3
30
29.9
34.7
26.6
19.1
30.3
33.1
32.5
22.9
17.3
9.5
18.5
10.2
19.6
17
8.1
20
23.8
35.8
17.5
24.2
27.2
25.5
22.3
21.5
21
24.2
9.5
Jun
16-30
47.2
34.6
46.9
35.9
43.9
36.3
26.7
43.1
42.8
42.2
40.1
33.8
21.9
34.3
22.6
32.9
33
15.4
27.5
38.8
49.6
29.8
35.3
37.2
31.6
29.5
31
29.1
31.1
13.3
Jul
1-15
61.4
46.3
57.9
42
51.9
46
36.3
55.1
50.3
50.1
54.9
53.2
42.7
52.5
41.8
48.9
52.5
27.8
35.6
55.1
60.4
46.1
48
47.3
38.8
38.5
43.5
38
38.3
20.5
Jul
16-31
65.9
54.2
62.8
48.5
56.9
53.5
47.9
61.3
54.9
55.6
63.8
66.5
58.6
64
54
63
66.4
40.7
44.6
66.1
70.2
60.5
63.1
58.8
52.5
51.1
60.4
45.9
46
33.6
Aug
1-15
69
61.7
66.2
56.9
61.3
60.2
61.4
65.7
59.7
60.5
70.7
75.9
71.1
72.3
64.5
73.5
75.7
52.6
56
73.6
77
72.7
76.1
67.6
66.8
65.2
75.1
54.5
54.9
52.8
Aug
16-31
77.2
72.9
72.1
67
67.3
68.3
75.1
72.1
68.9
67.5
81.5
87.6
84.6
83.3
78.7
83.3
85.5
61.1
70.2
81.8
84
86
87.7
74
75.5
77.8
86.1
65.4
64.2
66.5
Sep
1-15
86
82.5
79.1
76.9
73.9
75.8
84.5
77.9
78.1
74.3
89.8
93.7
91.9
90
88.4
89.5
91.3
69.3
81.3
87.7
88.8
92.8
93.5
79.2
81.2
85.6
91.6
74.8
73.2
76.7
Sep
16-31
91.6
89.6
85.9
85.8
80.1
82.6
92.3
82.6
83.6
79.4
96.3
97.5
97.1
95.1
96
95.6
96.5
82.6
89.2
93.8
93.8
96.8
97.2
86.7
87.9
91.7
96.2
82.1
81.9
88.1
Oct
1-15
94.8
93.7
91.1
91.2
85.1
88.3
96
86.3
87.5
84.1
98.7
99
99
97.3
98.7
98.3
98.8
92
93.6
97
96.6
98.4
98.6
92.6
92.8
95
98.1
87.5
88.5
94.2
Oct
16-31
98.7
98.2
97
95.7
89.6
96.3
99.1
90.3
93
91.1
99.2
99.7
99.8
98.5
99.4
99.6
100
98
98.5
99.4
99.1
99.7
99.5
97.9
98.3
98.7
99.4
95.4
95.7
98.6
Nov
1-15
100
99.7
98.9
97.8
93.2
99.3
100
93.8
96.5
95.8
99.3
100
100
98.9
99.7
100
100
100
100
100
100
100
99.8
99.8
100
100
99.9
98.8
98.6
100
Nov
16-31
100
99.9
98.9
99.6
98.2
99.9
100
98.4
99.2
99.1
99.4
100
100
98.9
99.7
100
100
100
100
100
100
100
99.9
99.9
100
100
99.9
99.7
99.4
100
Dec
1-15
100
99.9
98.9
100
99.8
100
100
100
100
100
99.4
100
100
98.9
99.8
100
100
100
100
100
100
100
100
100
100
100
100
100
99.7
100
Dec
16-31
100
99.9
98.9
100
99.8
100
100
100
100
100
99.7
100
100
99.2
99.9
100
100
100
100
100
100
100
100
100
100
100
100
100
99.7
100
-------
Table 1. Erosivity Index Table (cont)
El#
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
Jan
1-15
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Jan
16-31
0
0
0
0
3.6
0
0
2.3
2
0.5
0.7
0
0
0
0.1
0
0.2
0
0
0.6
0.1
0
0
0
0
0
0
0
0
1
Feb
1-15
0
0
0
0
7
0
0
4.5
3.7
0.7
1.2
0
0.1
0
0.1
0
0.3
0
0
1.2
0.1
0.1
0.1
0.1
0
0
0
0
1
2
Feb
16-29
0
0.1
0
0.7
9.6
0
0
7.8
5.7
1
1.6
0
0.1
0
0.1
0
0.3
0
0
1.6
0.2
0.1
0.1
0.1
0
0
0
0
1
3
Mar
1-15
0
0.3
0
2.8
11.4
0
0
10.4
7.8
1.3
2.1
0
0.2
0
0.2
0
0.4
0
0
2.1
0.4
0.2
0.1
0.2
0
0
1
1
2
4
Mar
16-31
0
0.8
0
7.4
13
0.1
0.1
12
10.5
1.7
2.8
0
0.2
0.1
0.5
0.1
0.8
0
0.2
2.5
0.5
0.2
0.3
0.3
0
0
1
1
3
6
Apr
1-15
0
2.1
0
12.4
14.4
0.5
0.4
13.3
12.4
2.2
3.3
0.1
0.3
0.2
1.3
0.2
1.5
0.2
0.7
3.3
0.8
0.5
0.9
0.6
1
1
2
2
4
8
Apr
16-30
1.3
3.6
0.9
14.4
16.3
1.1
0.9
16.3
13.7
2.8
3.6
0.2
0.6
0.5
1.9
0.6
2
0.5
1.3
4.5
0.9
1.2
1.6
1.7
2
2
3
3
7
13
May
1-15
5
6.5
3.7
15.6
17.7
2.2
1.6
17.7
14.3
3.4
4
0.7
1.3
1.2
3
1.3
2.8
1.6
2.7
6.9
1.5
3.1
3.5
4.9
3
3
6
6
12
21
May
16-31
8.5
9.7
7.8
17.3
18.4
3.6
1.9
18.1
14.7
3.9
4.5
0.8
4.1
2.7
4.1
2
3.9
3.8
5.8
10.1
3.9
6.7
8.3
9.9
6
6
10
13
18
29
Jun
1-15
15.5
13.7
13.3
19.4
19.3
6
2.4
18.2
15.1
4.7
5.6
1.3
11.5
6.4
6.6
3.5
5.9
8.9
12.7
15.5
9.9
14.4
19.4
19.5
11
11
17
23
27
37
Jun
16-30
29.8
16.5
15.8
21
20.5
7.6
5
18.3
15.7
5.4
6.5
3.5
18.1
10.2
10
4.9
7.2
13.2
18.8
19.7
12.8
20.1
30
27.2
23
23
29
37
38
46
Jul
1-15
41.8
20.8
19.9
24.4
23.6
11.1
12.1
18.4
17.1
7.4
9.1
9.9
28.3
18.4
17.6
8.4
10.3
21.8
28.8
26.6
18.2
29.8
44
38.3
36
36
43
51
48
54
Jul
16-31
46
27.3
29
32.3
32
19.8
24.8
19.9
22.7
15.7
18.5
24.7
40.2
31
28.3
17.4
21.5
35.8
41.6
36.4
30.7
44.5
59.2
52.8
49
49
55
61
55
60
Aug
1-15
49.2
40.1
46.8
48
50
38.9
48.3
24.5
36.7
36.5
40.6
51.4
54.1
50.7
44.7
37.3
46.5
56.6
58.4
51.7
54.1
64.2
72.4
68.8
63
63
67
69
62
65
Aug
16-31
56
56.9
64.7
61.4
66.2
59.7
73.6
35
50.4
55.8
59.7
71.5
67
68.7
59.4
57.5
66.3
75.4
75.7
67.5
77.1
83.1
84.6
83.9
77
77
77
78
69
69
Sep
1-15
65.1
72.6
78.3
72.1
77.2
74.4
86.5
54.4
63.6
70.3
74
83.6
77.2
81.2
71.6
72.9
78.3
86
86.5
79.4
89
92.2
91.2
91.6
90
90
85
85
76
74
Sep
16-31
71.6
83.4
88.8
81.9
85.4
83.2
92
69.4
75
80.9
86.3
93.8
87.7
91.6
83.9
83.7
86.5
92.9
94.2
88.8
94.9
96.4
96.5
96.4
95
95
91
91
83
81
Oct
1-15
78.6
89.4
93.9
87
88.8
88.1
94.3
78.6
81.8
86.4
91.7
97.7
93.3
96.1
90.3
89.5
90.8
95.9
97.3
93.2
97.2
98.1
98.6
98.2
98
98
96
94
90
87
Oct
16-31
91.1
95.5
98.5
90.1
90.4
94.6
96.6
85.7
87.8
90.9
94.7
99.2
97.5
98.4
94.7
95.8
96
98.2
98.9
96.1
98.7
99.3
99.5
99.2
99
99
98
96
94
92
Nov
1-15
97.3
98.1
100
92.4
91.3
97.7
97.9
89.2
90.8
93.4
96
99.8
99.1
99.2
96.7
98.4
98.2
99.2
99.5
97.3
99.3
99.7
99.8
99.6
100
100
99
98
97
95
Nov
16-31
99.3
99.6
100
98.1
92.7
99.4
99.5
91.9
93.2
96.4
96.7
99.9
99.6
99.8
98.8
99.6
99.1
99.8
99.9
98.2
99.6
99.8
99.9
99.8
100
100
100
99
98
97
Dec
1-15
100
100
100
100
94.8
100
100
93.9
94.9
98.1
97.3
99.9
99.8
100
99.6
100
99.5
100
100
98.7
99.7
99.8
100
99.8
100
100
100
99
99
98
Dec
16-31
100
100
100
100
97
100
100
97
97.5
99.4
98.8
100
100
100
99.9
100
99.8
100
100
99.3
99.9
99.9
100
99.9
100
100
100
100
100
99
-------
Table 1. Erosivity Index Table (cont.)
El#
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
Jan
1-15
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Jan
16-31
0
0
1
1
1
2
1
1
0
0
0
0
1
2
1
3
3
3
3
1
1
0
1
1
1
1
1
2
1
8
Feb
1-15
0
0
1
2
3
4
3
2
0
0
0
1
2
3
3
6
5
6
6
3
2
0
2
2
2
3
2
4
2
16
Feb
16-29
0
0
2
4
5
6
5
4
1
0
1
2
3
5
6
9
7
9
10
5
3
1
3
4
3
5
3
6
4
25
Mar
1-15
1
1
3
6
7
9
7
6
1
1
2
3
4
7
9
13
10
12
13
7
4
2
4
6
4
7
4
8
6
33
Mar
16-31
1
1
4
8
9
12
10
8
2
1
3
4
6
10
12
17
14
16
16
9
5
3
5
8
5
9
5
12
7
41
Apr
1-15
1
1
6
10
11
17
14
10
3
2
4
6
8
13
16
21
18
20
19
12
6
4
6
11
6
12
7
16
9
46
Apr
16-30
2
2
8
15
14
23
20
13
5
3
6
8
10
16
21
27
23
24
23
15
8
5
8
13
8
15
9
20
12
50
May
1-15
6
6
13
21
18
30
28
19
7
5
9
11
14
19
26
33
27
28
26
18
11
7
10
11
10
18
11
25
15
53
May
16-31
16
16
25
29
27
37
37
26
12
9
14
15
18
23
31
38
31
33
29
21
15
12
12
13
14
21
14
30
18
54
Jun
1-15
29
29
40
38
35
43
48
34
19
15
20
22
25
27
37
44
35
38
33
25
20
17
17
21
19
25
17
35
23
55
Jun
16-30
39
39
49
47
41
49
56
42
33
27
28
31
34
34
43
49
39
43
39
29
28
24
22
26
26
29
22
41
31
56
Jul
1-15
46
46
56
53
46
54
61
50
48
38
39
40
45
44
50
55
45
50
47
36
41
33
31
32
34
36
31
47
40
56.5
Jul
16-31
53
53
62
57
51
58
64
58
57
50
52
49
56
54
57
61
53
59
58
45
54
42
42
38
45
45
42
56
48
57
Aug
1-15
60
60
67
61
57
62
68
63
65
62
63
59
64
63
64
67
60
69
68
56
65
55
52
46
56
56
54
67
57
57.75
Aug
16-31
67
67
72
65
62
66
72
68
72
74
72
69
72
72
71
71
67
75
75
68
74
67
60
55
66
68
65
75
63
58
Sep
1-15
74
74
76
70
68
70
77
74
82
84
80
78
79
80
77
75
74
80
80
77
82
76
68
64
76
77
74
81
72
58.75
Sep
16-31
81
81
80
76
73
74
81
79
88
91
87
85
84
85
81
78
80
84
83
83
87
83
75
71
82
83
83
85
78
60
Oct
1-15
88
88
85
83
79
78
86
84
93
95
91
91
89
89
85
81
84
87
86
88
92
89
80
77
86
88
89
87
88
61
Oct
16-31
95
95
91
88
84
82
89
89
96
97
94
94
92
91
88
84
86
90
88
91
94
92
85
81
90
91
92
89
92
63
Nov
1-15
99
99
97
91
89
86
92
93
98
98
97
96
95
93
91
86
88
92
90
93
96
94
89
85
93
93
95
91
96
66.5
Nov
16-31
99
99
98
94
93
90
95
95
99
99
98
98
97
95
93
90
90
94
92
95
97
96
92
89
95
95
97
93
97
72
Dec
1-15
100
100
99
96
96
94
98
97
100
99
99
99
98
96
95
94
93
96
95
97
98
98
96
93
97
97
98
95
98
80
Dec
16-31
100
100
99
98
98
97
99
99
100
100
100
100
99
98
97
97
95
98
97
99
99
99
98
97
99
99
99
97
99
90
-------
Table 1. Erosivity Index Table (cont)
0
El#
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
Jan
1-15
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Jan
16-31
7
4
4
7
9
8
8
9
10
8
10
8
12
7
11
10
11
8
10.6
0.2
10.7
2.7
8.7
4.3
11.7
4.8
0
5.5
2.4
Feb
1-15
14
8
9
12
16
15
15
16
20
15
18
16
22
15
21
18
22
14
21.2
0.3
21.4
5.5
17.5
8.6
23.3
9.6
4.7
11
4.9
Feb
16-29
20
12
15
17
23
22
22
22
28
22
25
24
31
22
29
25
31
20
28.6
0.3
28.7
5.7
25.2
9.3
33.5
13.1
9.4
19.2
7.4
Mar
1-15
25.5
17
23
24
30
28
29
27
35
28
29
32
39
30
37
30
39
25
36
0.3
36
5.9
33
10.1
43.7
16.5
10.8
27.5
9.9
Mar
16-31
33.5
23
29
30
37
33
34
32
41
33
33
40
45
37
44
39
46
32
41.4
0.3
41.7
7.1
39.9
11.1
50.7
22.6
12.2
36.6
11.7
Apr
1-15
38
29
34
39
43
38
40
37
46
38
36
46
49
43
50
46
52
37
46.8
0.3
47.3
8.4
46.7
12
57.6
28.7
13.2
45.7
13.6
Apr
16-30
43
34
40
45
47
42
45
41
49
41
39
51
52
49
55
51
56
42
49.3
0.8
50.3
10
50.8
15.3
60.3
30.8
14.3
47.8
14.6
May
1-15
46
38
44
50
50
46
48
45
51
44
41
54
54
53
57
54
58
47
51.8
1.3
53.2
11.7
54.8
18.6
63
32.8
14.9
50
15.6
May
16-31
50
44
48
53
52
50
51
48
53
47
42
56
55
55
59
57
59
50
52.5
5.3
54.5
15.3
56.2
22.7
63.5
33.3
15.5
50.9
16.2
Jun
1-15
52.5
49
50
55
54
52
54
51
55
49
44
57
56
57
60
58
60
53
53.2
9.3
55.7
19
57.6
26.7
64.1
33.8
24.2
51.7
16.8
Jun
16-30
54.5
53
51
56
55
53
57
53
56
51
45
58
56
58
60
59
61
55
53.5
30.1
56.2
22.6
58
28.7
64.2
34
32.8
52.1
17.2
Jul
1-15
56
56
52
57
56
53
59
55
56
53
46
58
56
59
60
59
61
56
53.7
50.8
56.7
26.1
58.4
30.7
64.2
34.2
45.5
52.5
17.7
Jul
16-31
58
59
53
58
57
53
62
56
57
55
47
59
56
60
60
60
61
58
53.9
56.8
56.9
29
58.9
31.3
64.5
36.4
58.2
54.2
24.7
Aug
1-15
59
62
55
59
58
53
63
57
58
56
48
59
57
61
61
60
61
59
54
62.9
57
31.9
59.4
32
64.8
38.6
67.9
55.9
31.7
Aug
16-31
60
65
57
61
59
54
64
57
59
58
49
60
57
62
61
60
62
61
54.3
67.5
57.4
36.6
60.8
34
66.1
43
77.6
60.1
46.9
Sep
1-15
61.5
69
60
62
60
55
65
58
60
59
51
60
57
63
61
61
62
63
54.7
72.2
57.8
41.2
62.3
36
67.3
47.5
86.3
64.4
62.1
Sep
16-31
63
72
62
63
62
57
66
59
61
60
53
61
57
65
62
62
62
64
55.7
75.8
59
46
64.1
44.4
68.6
56
95.1
70.5
67
Oct
1-15
65
75
64
64
64
59
67
61
62
63
56
62
58
67
63
63
63
66
56.8
79.4
60.2
50.7
65.9
52.9
69.8
64.5
95.6
76.7
72
Oct
16-31
68
79
67
66
67
63
69
64
65
65
59
64
59
70
64
64
64
68
61.6
85.6
64.1
62.3
68.8
60.1
70.7
66.2
96.1
81.2
80.7
Nov
1-15
72
83
72
70
71
68
72
68
69
69
64
68
62
74
67
67
66
71
65.3
91.7
67.9
73.9
71.7
67.3
71.6
67.9
98
85.7
89.3
Nov
16-31
79
88
80
77
77
75
76
73
74
75
70
74
68
79
71
72
71
76
73.9
95.9
76.1
83.5
78.6
78.2
79.2
77.9
100
90.4
92.3
Dec
1-15
86
93
88
84
86
83
83
79
81
84
80
83
77
85
78
80
78
85
82.5
100
84.2
93.1
85.5
89.2
86.7
88
100
101
95.3
Dec
16-31
93
96
95
92
93
92
91
89
90
92
90
91
88
92
89
90
89
93
91.2
100
92.1
96.6
92.7
94.6
93.4
94
100
97.6
97.7
-------
United States Solid Waste and EPA530-F-01-008
Environmental Protection Emergency Response May 2001
Agency (5305W) www.epa.gov/osw
Office of Solid Waste
&EPA Environmental
Fact Sheet
LOW-LEVEL MIXED WASTE CONDITIONALLY
EXEMPT FROM HAZARDOUS WASTE
REGULATION
The Environmental Protection Agency (EPA) is reducing regulatory burdens by
exempting qualified mixed-waste generators from certain hazardous waste
management requirements.
Background
Mixed waste is hazardous waste containing radioactive material. This waste is
regulated by both the Resource Conservation and Recovery Act (RCRA) and the
Atomic Energy Act. The Department of Energy or the Nuclear Regulatory
Commission (NRG) regulate the radiological components of the waste.
Summary
EPA is providing increased flexibility to facilities for managing low-level mixed
waste (LLMW) and naturally occurring and/or accelerator-produced radioactive
material (NARM) containing hazardous waste. The Agency is exempting low-level
mixed waste from RCRA storage and treatment requirements as long as the waste
is generated under a single NRG license, meets the conditions specified, and is
stored and treated in a tank or container. In addition, LLMW and NARM, which
meet applicable treatment standards, may be conditionally exempt from RCRA
transportation and disposal requirements. This waste may be disposed of at low-
level radioactive waste disposal facilities which are licensed by NRG. The rule also
provides additional flexibility for manifesting these wastes when they are destined
for disposal at such facilities. Although mixed waste meeting the applicable
conditions is exempt from certain RCRA requirements, it must still be managed as
radioactive waste according to NRG regulations. Note that DOE disposal facilities
are not eligible to accept the exempt waste since they are not subject to NRG
regulation.
For More Information
The Federal Register notice, this fact sheet, and related documents are available
on the Internet at . For additional
information, or to order paper copies of any documents, call the RCRA Call Center.
Callers within the Washington Metropolitan Area please dial 703-412-9810 or TDD
-------
703-412-3323 (hearing impaired). Long-distance callers please call 1-800-424-9346
or TDD 1-800-553-7672. The RCRA Call Center operates weekdays, 9:00 a.m. to
5:00 p.m. Address written requests to: RCRA-Docket@epa.gov or RCRA Information
Center (5305W), 1200 Pennsylvania Avenue, NW, Washington, DC 20460-0001.
-------
FBI contacts for suspicious pesticide/OP nerve gas incidents
Introduction
The purpose of this note is to provide Poison Control Centers and others with a list of points of contact at FBI field
offices throughout the nation and information about the National Response Center. These resources are provided to
assist Poison Centers with surveillance related to terrorist attacks. Recently, Krenzelok et al. (Vet Hum Toxicol
42(5):297-300, 2000) summarized the important role of Poison Centers in biological and chemical terrorism. An
important component of surveillance is identification of sentinel events that precede a terrorist attack and provide
opportunities for prevention. This is most clearly illustrated by examining the events leading up to 1995 attack on
the Tokyo subway by a religious cult, known as the Aum Shinrokyo.
History of the Tokyo Subway Attack
On March 20, 1995, bags of sarin, an organophosphate (OP) nerve gas, were simultaneously placed on five subway
trains in Tokyo. After the bags were punctured by religious cult members, 5,500 people were poisoned and 12
people died. Prior to this attack there were a number of incidents involving the cult and sarin or other chemical and
biological weapons. Most notably, nine months before the subway attack, seven deaths occurred and 600 people
were poisoned due to a release of sarin in an apartment complex in Matsumoto. In addition, there were at least three
occasions where leaks from the sarin manufacturing facility used by the cult resulted in complaints of eye and nose
irritation and nausea from the residents who lived nearby. Only after the third leak in November 1994 did police
positively identify sarin in soil samples. Two incidents have been identified where the cult used nerve gas (VX or
sarin) to assassinate or attempt to assassinate perceived enemies of the cult. Evidence collected in Australia suggests
29 sheep were killed with sarin on a farm purchased by the same cult. Had any of these incidents been properly
reported and fully investigated, the subsequent terrorist attacks on the Japanese subway might have been
prevented.
Pesticides and OP Nerve Agents Likely Weapons of Terrorists
The Table below lists those pesticides and OP nerve agents judged most likely to be used in a terrorist attack. The
main criteria for this list were high dermal or inhalation toxicity, common malicious use reported, and prior use by
terrorists. For a more complete list of potential chemical and biological agents see the CDC's strategic plan for
biological and chemical terrorism (MMWR 49 (RR-4): 1-14, 2000 or
http ://www. cdc.gov/mmwr/preview/mmwrhtml/rr4904al. htm).
A printed copy can be obtained via Internet using an adobe acrobat reader. Familiarity with the contents of CDC's
strategic plan and the Krenzelok et al. (2000) article on the role of Poison Centers is recommended for each poison
specialist. Federal and state governmental agencies, and other non-governmental agency representatives who may
receive sentinel reports of suspected terrorist attacks should also be familiar with these resources.
The World Health Organization (WHO) classifies the most toxic pesticides as la extremely hazardous and Ib highly
hazardous. The U.S. Environmental Protection Agency (EPA) uses a similar system that classifies the most toxic
pesticides in Toxicity Category I that require the signal word "Danger" on the pesticide label. Most or all uses of the
pesticides listed in the Table below are classified in category 1 by WHO and EPA.
According to Trestrail (2000), the three most widely employed homicidal poisons are primarily pesticides.
Arsenicals, cyanide, and strychnine account for 46% of the homicidal poisonings analyzed. Three other pesticides or
chemicals with pesticidal uses were among the top ten (mercurials, thallium, and paraquat). Aldicarb can be added
to this list because of its extremely high toxicity, numerous reports of malicious use against animals, and the largest
outbreak of food poisoning in the US caused by pesticides (Frazier et al. 1999, Goldman et al. 1990, see also CDC
1997, CDC 1999). Note that EPA has cancelled the registration of most of these pesticides or permits only
restricted use by certified applicators or their employees. So that any suspicious use or possession of these pesticides
by the general public should be reported to the FBI. Non-malicious misuse should be reported to appropriate State
authorities (see appendix 1 for list of contacts).
-------
Table 1. Highly toxic pesticides and OP nerve agents judged likely to be used by terrorists or for malicious intent.
Nerve agent or pesticide
Organophosphate nerve gas:
sarin (GB)
tabun (GA)
soman (GD)
GF
VX
OP insecticides:
ethyl parathion*
fonofos*
mevinphos*
monocrotophos*
TEPP* (tetraethyl diphosphate)
azinphosmethyl
disulfoton
methamidophos
methidathion
methyl parathion
phorate
sulfotepp
terbufos
Carbamate insecticides:
aldicarb
carbofuran
methomyl
Arsenical insecticides (especially
trivalent arsenites). Examples include:
sodium arsenite*
copper acetoarsenite*
arsenic trioxide*
Methylmercury compounds* and
inorganic mercurials*. Examples include:
mercuric chloride*
phenylmercuric acetate*
methoxyethyl mercury*
ethylmercury-p-toluene sulfonanilide*
methylmercury dicyandiamide*
Common trade name or
synonym
Parathion
Dyfonate
Phosdrin
Azodrin
Guthion
Disyston
Monitor
Supracide
Thimet
Bladafume
Counter
Temik
Furadan
Lannate
Paris Green
White arsenic
PMA, Agrosan
Panogen
Ceresan M
Panogen Turf Spray
CAS No.
107-44-8
77-81-6
96-64-0
329-99-7
50782-69-9
56-38-2
944-22-9
7786-34-7
6923-22-4
107-49-3
86-50-0
298-04-4
10265-92-6
950-37-8
298-00-0
298-02-2
3689-24-5
13071-79-9
116-06-3
1563-66-2
16752-77-5
7784-46-5
12002-03-8
1327-53-3
7487-94-7
62-38-4
151-38-2
517-16-8
502-39-6
Terrorist (T) or
Malicious (M) use
T
T
T
T
T
M
M
TM
TM
-------
Nerve agent or pesticide
Rat poisons:
sodium fluoroacetate
strychnine
thallium sulfate*
Cyanides*. Examples include:
hydrogen cyanide*
sodium cyanide*
Fumigants:
aluminum phosphide
methyl bromide
sulfuryl fluoride
Paraquat herbicide
Common trade name or
synonym
Compound 1080
Thallium
Prussic acid
M-44 capsules
Phostoxin, Fumitoxin
Meth-O-Gas, Brom-O-Gas
Vikane
Gramoxone
CAS No.
62-74-8
57-24-9
7446-18-6
74-90-8
143-33-9
20859-73-8
74-83-9
2699-79-8
4685-14-7
Terrorist (T) or
Malicious (M) use
M
TM
TM
M
* All or practically all uses of these pesticides have been banned by EPA or are being phased out. All other
pesticides in this Table are contained in products that are almost always restricted to use by certified applicators or
someone under their supervision.
Identifying Sentinel Events
CDC's Strategic Planning Workgroup (MMWR 49 (no. RR-4):1-14) prepared a report titled "Biological and
Chemical Terrorism: Strategic Plan for Preparedness and Response" which states that "disease surveillance systems
at state and local health agencies [such as PCCs] must be capable of detecting unusual patterns of disease or injury,
including those caused by unusual or unknown threat agents." Among the clues that can be used to identify a
sentinel event are:
1. Exposure or poisoning due to one of the highly toxic agents listed in the Table involving individuals who would
not normally have reason to have access to the compound.
2. Clusters of reports where several people are exposed to a product outside its normal use pattern (e.g., residential
or urban poisoning by an agricultural pesticide).
3. Multiple simultaneous patients with similar clinical syndrome, especially in young or otherwise healthy.
Reports of sick or dead animals (Richards et al. 1999).
4. Rapid onset or unexpectedly severe effects including pinpoint pupils, increased secretions, blurred or dim vision,
incontinence, respiratory distress, convulsions, or coma suggests a cholinesterase-inhibiting pesticide or nerve agent
(Krenzelok et al. 2000).
5. Suspicious reports of 'experiments' or 'accidental leaks' involving highly toxic chemicals.
6. Reports of malicious use where circumstances suggest that the perpetrator is attempting to make a political
statement or achieve notoriety for a cause.
Reporting a Suspicious Incident
-------
Below is a list of FBI field office contacts, please identify the appropriate contact(s) for the catchment area served
by your Poison Center and have the telephone number on hand for all poison specialists. This is the person that
should be contacted when there is suspicion of terrorist activity.
FBI Field Weapons of Mass Destruction Coordinators (updated 9/7/2000)
Name
Eric Washburn
Gary Greenwell
Thomas P. Lynch
Leroy Dempsey
William Stewart
Jon Watson
James Barry
Stephanie Olinger
Lawrence E. Strayer
Russ Chisholm
Glenn D. Barnes
David Martinex
Howard Kaeding
William Hargreaves
Albert McGinty
Roger Stanton
Donald Borelli
Stan Strauss
Joseph Airey
Keith Howland
Gary A. Francis
Michael Thomas
David Lujan
Kurt Schmidt
Patrick S. Turner
Doug Brigante
Benjamin Landers Jr.
Michael Harris
Charles G. Smith
Michael Farhart
Hank Everett
Thomas Dalton
Kent Spalsbury
Todd E. Sanstedt
Robin Salvador
Rick Florence
Richard Bellamy
Kevin Miles
David Baker
Kenneth D. Lane
FBI Office
Albany, NY
Albuquerque, NM
Anchorage, AK
Anchorage, AK
Atlanta, GA
Atlanta, GA
Baltimore, MD
Baltimore, MD
Birmingham, AL
Boston, MA
Buffalo, NY
Charlotte, NC
Chicago, IL
Cincinnati, OH
Cleveland, OH
Columbia, SC
Dallas, TX
Dallas, TX
Denver, CO
Denver/Colorado Springs, CO
Detroit, Ml
Detroit, Ml
El Paso, TX
El Paso, TX
El Paso, TX
Honolulu, HI
Houston, TX
Houston, TX
Indianapolis, IN
Jackson, MS
Jacksonville, FL
Kansas City, MO
Kansas City, MO
Knoxville/Oak Ridge, TN
Las Vegas, NV
Las Vegas, NV
Little Rock, AR
Los Angeles, CA
Los Angeles, CA
Louisville, KY
Work Phone #
518/431-7463
505/224-2306
907/265-9547
404/679-6247
404/679-3096
410/281-0347
410/281-0110
205/715-0254
617/223-6223
716/843-5229
704/331-4564
312/786-3789
513/562-5742
216/622-6683
803/551-4361
214/922-7669
214/922-7351
303/628-3088
719/329-6542
313/237-4052
313/237-4271
915/832-5100
915/832-5000
915/832-5000
808/566-4386
713/693-3823
713/693-3817
317/639-3301
601-360-7760
904/727-6126
816/512-8822
816/512-8824
865/482-7122
702/383-3581
702/383-3570
501/228-8453
310/996-3850
310/996-3903
502/569-3820
Fax#
518/431-7463
505/224-2276
907/265-9599
907/265-9599
404/679-1483
404/679-1483
410/298-9427
205/715-0293
617/223-6327
716/843-5288
704/331-4595
312/786-3790
513/562-5650
216/622-6717
803/551-4240
214/922-7330
214/922-7730
303/628-3040
719/329-6579
313/237-4009
313/237-4009
915/832-5259
915/832-5259
915/832-5259
808/566-4390
713/693-3908
713/693-3908
317/321-6193
601/360-7644
904/727-6242
816/512-8545
816/512-8545
865/482-6192
702/383-3519
702/383-3519
501/228-8545
310/996-3885
310/996-3885
502/569-3869
-------
William Rasmussen
SSAJ.W. Brown
John Bellamy
IRS David Powers
SSA Michele Formico
Thomas Deans
Morris Moriwaki
Jack Felske
Philip T. Brookmam
John A. Dalziel
James "Doug" Kouns
Michael McRoden
Charles English
Eli Richardson
Ted Kuhlmeier
SAJeff Garrett
SSA James McGee
William A. Zinnikas
John Jackloski
Greg Hartman
Frank Alexander
Kenneth Kaminski
Arlyn Slagter
Bruce Stofko
Christopher Rigopoulos
Gary LeGore
Christopher Gay
Todd Kopcha
Jim George
Earl Freilino
Daniel Toft
Gerald Kouchi
Thomas Durham
Thomas D. Stieler
Robert Born
Joseph Sheehan
Ronald W. Parker
Claron (Chip) Spencer
Robert Rose
John T. Sylvester
John Lightfoot
Luis E. Nunez
Greg Jennings
FrederickW. Humphries II
Robert Brown
SSRAK. Killham
Larry M. Skora
Memphis, TN
Memphis, TN
Miami, FL
Miami, FL
Milwaukee, Wl
Milwaukee, Wl
Milwaukee, Wl
Milwaukee, Wl
Minneapolis, MN
Minneapolis, MN/Fargo, ND
Minneapolis/Sioux Falls, SD
Minneapolis, MN/Rapid City, SD
Mobile, AL
Newark, NJ
New Haven, CT
New Orleans, LA
New Orleans, LA
New York, NY
Norfolk, VA
Norfolk, VA
Oklahoma City, OK
Oklahoma City, OK
Omaha, NE
Omaha, NE
Philadelphia, PA
Philadelphia, PA
Phoenix, AZ
Phoenix, AZ
Phoenix, AZ
Pittsburgh, PA
Pittsburgh, PA
Portland, OR
Portland, OR
Richmond, VA
Sacramento, CA
Sacramento, CA
St. Louis, MO
Salt Lake City, UT
San Antonio, TX
San Diego, CA
San Francisco, CA
San Juan, NM
Seattle, WA
Seattle, WA
Springfield/Peoria, IL
Springfield (North), IL
Springfield (South), IL
901/747-9683
901/747-9623
305/787-6122
305/787-6312
414/291-4280
414/291-4280
414/291-4335
414/276-4684
612/376-3372
701/232-7241
605/321-1156
605/343-9632
334/415-3242
973/792-7418
203/503-7195
504/816-3099
504/816-3007
212/384-8525
757/455-2631
757/455-2640
405/290-3698
918/665-5210
402/492-3763
402/493-8688
215/418-4097
901/747-9621
901/747-9621
305/787-6495
305/787-6539
414/276-6560
414/276-6560
414/276-6560
414/276-6560
612/376-3249
701/237-9948
605/334-6704
605/343-7065
334/415-3235
973/792-3035
203/503-7098
504/816-3135
212/384-8551
757/455-2647
757/455-2647
405/290-3779
918/665-5235
402/492-3799
402/492-3799
215/418-4460
717/232-8689x117
602/650-3082
602/650-3281
602/650-3010
412/456-9318
412/456-9271
503/552-5223
503/552-5346
804/261-8024
916/977-2222
916/977-2259
314/589-2561
801/579-4626
210/978-5363
858/514-5614
510/251-4162
787/759-5671
206/262-2678
206/654-7237
309/676-1922
217/352-0411
618/624-6248
602/604-3406
602/650-3204
412/456-9166
503/423-9746
503/423-9746
804/261-8077
916/977-2300
916/977-2300
314/589-2500
801/579-4500
210/978-5380
858/514-5991
510/251-4193
787/759-1561
206/654-7262
206/654-7262
309/676-2508
217/353-7210
618/622-2049
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1 Steve Miller
D.J. Hathaway
Melissa Godbold
Tampa, FL
Washington, DC
Washington, DC
813/272-8039
202/278-4467
202/278-4480
813/272-8019
202/278-4559
202/278-4559
If the incident involves the spill or discharge that requires professional clean up, then you should contact the
National Response Center at 1-800-424-8802 which also takes reports of actual or potential domestic terrorism 24
hours a day, 365 days a year. They also maintain a link with the FBI to initiate federal response. The National
Response Center (http://www.nrt.org/) is the sole national point of contact for reporting oil, chemical, radiological,
and biological discharges. In effect, they are like a federal 911 service for environmental incidents. The NRC is the
operations and communications center for the National Response Team (NRT), a planning, policy, and coordinating
organization. This group is chaired by the U.S. Environmental Protection Agency and the vice-chair is U.S. Coast
Guard. Additional EPA contacts for response to terrorist activity are provided in appendix 2.
References
Centers for Disease Control and Prevention (CDC). 2000. Biological and Chemical Terrorism: Strategic Plan for
Preparedness and Response. Recommendations of the CDC Strategic Planning Workgroup. MMWR 49 (no. RR-
CDC. 1997. Poisonings associated with illegal use of aldicarb as a rodenticide ~ New York City, 1994-1997.
MMWR46(41):961-963.
CDC. 1999. Aldicarb as a cause of food poisoning -Louisiana, 1998. MMWR 48(13)269-271.
Frazier K, Hullinger G, Hines M, Liggett A, Sangster L. 1999. 162 cases of aldicarb intoxication in Georgia
domestic animals from 1988-1998. Vet Hum Toxicol 41(4):233-235.
Goldman LR, Beller M, Jackson RJ. 1990. Aldicarb food poisonings in California, 1985-1988: toxicity estimates
for humans. Arch Environ Health 45:141-147.
Krenzelok EP, Allswede MP, Mrvos R. 2000. The Poison Center role in biological and chemical terrorism. Vet
Human Toxicol 42(5):297-300.
Richards CF, Burstein JL, Waeckerle IF, Hutson HR. 1999. Emergency physicians and biological terrorism.
Annals of Emergency Medicine 34:183-190.
Trestrail III JH. 2000. Criminal Poisoning. Humana Press: Totowa, NJ.
Appendix 1: Reporting Pesticide misuse to State authorities or EPA
Each state has an enforcement agency, usually the State Department of Agriculture or Environment, which handles
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violations of FIFRA (Federal Insecticide, Fungicide and Rodenticide Act). Any use of a pesticide, not in accordance
with label instructions, is considered a violation and may be referred for enforcement action. If you do not know your
state's enforcement contact, check with EPA's NPTN (1-800-858-7377) for assistance.
For additional pesticide-related assistance, including food contamination:
Frank Davido, Incident Response Officer
Office of Pesticide Programs, EPA (7502C)
1200 Pennsylvania Ave. NW, Washington, DC 20460
Email: Davido.Frank@EPA.GOV
(703) 305-7576, Fax: (703) 305-4646
For pesticide-enforcement related issues:
Jack Neylan, Agricultural Branch Chief
Office of Compliance, EPA (2225 A)
1200 Pennsylvania Ave. NW, Washington, DC 20460
Email: Neylan.John@EPA.GOV
(202) 564-2385, Fax: (202) 564-0034
Appendix 2: Additional EPA assistance for non-pesticide emergencies and terrorist activity
Ken Stroech, EPA Deputy Emergency Coordinator
Chemical Emergency Preparedness & Prevention Office
1200 Pennsylvania Ave. NW (5104), Washington, DC 20460
Email: Stroech.Ken@EPA.GOV
(202) 564-3434, Fax: (202) 564-8333
EPA Regional Counter Terrorist Points of Contact
Name
Cosmo Caterino
im Daloia
vfeil Norrell
Vlarty Powell
Shane Hitchcock
7red Stroud
xn Zintak
Cenneth Clark
anice Kroone
im Knoy
'eter Stevenson
Perry Brubaker
William Lewis
effrv Rodin
Region/States
I- CT, ME, NH, RI, VT
II- NJ, NY PR, VI
II- NJ, NY PR, VI
III- DE, DC, MD, PA, VA,
WV
IV- AL, FL, GA, KY, MS, NC,
SC, TN
IV- AL, FL, GA, KY, MS, NC,
SC, TN
V- IL, IN, MI, MN, OH, WI
VI- AR, LA, MM, OK, TX
VII- AR, LA, MM, OK, TX
VIII- CO, MT, ND, SD, UT
VIII- CO, MT, ND, SD, UT
IX- AZ, CA, HI, NV, AS, GU
IX- AZ, CA, HI, NV, AS, GU
X- AK ID OR WA
Phone
617-918-1264
732-906-6907
732-321-4357
304-234-0252
404-562-8718
404-562-8751
312-886-4246
214-665-6774
913-551-7005
303-312-6838
303-312-6799
415-744-2293
415-744-2292
206-553-6709
Fax
617-918-1291
732-321-4425
732-321-4425
304-234-0259
404-562-8699
404-562-8699
312-353-9176
214-665-7447
913-551-7948
303-312-6071
415-744-1916
206-553-0175
S-mail
caterino.cosmo@epa.gov
daloia.iames@epa.gov
norrell .neil@epa.gov
)owell .martin@epa.gov
iitchcock.shane@epa.gov
stroud.fred@epa.gov
zintak.leonard@epa.gov
clark.kenneth@epa.gov
croone .) anice@epa.gov
cnoy.iim@epa.gov
stevenson.peter@epa.gov
jrubaker .terry@epa.gov
ewis.bill@epa.gov
rodin.ieffrvf2)ena.2ov
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United States
Environmental Protection
Agency
Enforcement and
Compliance Assurance
(2221-A)
EPA 300-B-00-003
September 2000
Protocol for Conducting
Environmental Compliance
Audits under the Federal
Insecticide, Fungicide, and
Rodenticide Act (FIFRA)
EPA Office of Compliance
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Notice
The statements in this document are intended solely as guidance to aid regulated entities in complying with the
regulations. The guidance is not a substitute for reading the regulations and understanding all the requirements as it
applies to your facility. This guidance does not constitute rulemaking by the U.S. EPA and may not be relied on to
create a substantive or procedural right or benefit enforceable, at law or in equity, by any person. U.S. EPA may
decide to update this guide without public notice to reflect changes in U.S. EPA's approach to implementing the
regulations or to clarify and update text. To determine whether U.S. EPA has revised this document and/or to obtain
copies, contact U.S. EPA's Center for Environmental Publications at 1(800) 490-9198. Additional information
regarding U.S. EPA Hotlines and further assistance pertaining to the specific rules discussed in this document can be
found at the end of the Key Compliance Requirements located in Section II. The contents of this document reflect
regulations issued as of August 11,2000.
Acknowledgements
U.S. EPA would like to gratefully acknowledge the support of the U.S. Army Corps of Engineers Construction
Engineering Research Laboratory (CERL) for providing suggestions for overall format of this document. The Office
of Compliance at U.S. EPA gratefully acknowledges the contribution of U.S. EPA's program offices and the U.S.
EPA's Office of Counsel in reviewing and providing comment on this document.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Table of Contents
Notice inside cover
Acknowledgement inside cover
Section 1: Introduction
Background ii
Who Should Use These Protocols? ii
U.S. EPA's Public Policies that Support Environmental Auditing iii
How To Use the Protocols iv
The Relationship of Auditing to Enviornmental Management Systems vii
Section II: Audit Protocol
Applicability 1
Review of Federal Legislation 1
State and Local Regulations 2
Key Compliance Requirements 2
Key Terms and Definitions 3
Typical Records to Review 20
Typical Physical Features to Inspect 20
List of Acronyms 20
Index for Checklist Users 23
Checklist 25
Appendices
Appendix A: Exempted Pesticides Al
Appendix B: Restricted-Use Pesticides Bl
Appendix C: General Standards for All Categories of Certified Commercial Applicators Cl
Appendix D: Specific Standards for Competency for Each Category of Certified Commercial
Applicators Dl
AppendixE: Entry Restricted Areas inNurseries during Pesticide Applications El
Appendix F: Greenhouse Entry Restrictions Associated with Pesticide Applications Fl
Appendix G: User Satisfaction Questionnaire and Comment Forms Gl
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Section I
Introduction
Background
The Environmental Protection Agency (U.S. EPA) is responsible for ensuring that businesses and organizations
comply with federal laws that protect the public health and the environment. U.S. EPA's Office of Enforcement and
Compliance Assurance (OECA) has begun combining traditional enforcement activities with more innovative
compliance approaches including the provision of compliance assistance to the general public. U.S. EPA's Office of
Compliance Assistance was established in 1994 to focus on compliance assistance-related activities. U.S. EPA is
also encouraging the development of serf-assessment programs at individual facilities. Voluntary audit programs
play an important role in helping companies meet their obligation to comply with environmental requirements. Such
assessments can be a critical link, not only to improved compliance, but also to improvements in other aspects of an
organization's performance. For example, environmental audits may identify pollution prevention opportunities that
can substantially reduce an organization's operating costs. Environmental audits can also serve as an important
diagnostic tool in evaluating a facility's overall environmental management system or EMS.
U.S. EPA is developing 13 multi-media Environmental Audit Protocols to assist and encourage businesses and
organizations to perform environmental audits and disclose violations in accordance with OECA's Audit and Small
Business Policies. The audit protocols are also intended to promote consistency among regulated entities when
conducting environmental audits and to ensure that audits are conducted in a thorough and comprehensive manner.
The protocols provide detailed regulatory checklists that can be customized to meet specific needs under the
following primary environmental management areas:
• Generation of RCRA
Hazardous Waste
Treatment Storage and
Disposal of RCRA
Hazardous Waste
• EPCRA
• CERCLA
• Safe Drinking Water Act
• Managing Nonhazardous
Solid Waste
Clean Air Act
TSCA
Pesticides Management
(FIFRA)
• RCRA Regulated Storage
Tanks
• Clean Water Act
• Universal Waste and Used Oil
• Management of Toxic
Substances (e.g., PCBs,
lead-based paint,
and asbestos)
Who Should Use These Protocols?
U.S. EPA has developed these audit protocols to provide regulated entities with specific guidance in periodically
evaluating their compliance with federal environmental requirements. The specific application of this particular
protocol, in terms of which media or functional area it applies to, is described in Section II under "Applicability".
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
The Audit Protocols are designed for use by individuals who are already familiar with the federal regulations but
require an updated comprehensive regulatory checklist to conduct environmental compliance audits at regulated
facilities. Typically, compliance audits are performed by persons who are not necessarily media or legal experts but
instead possess a working knowledge of the regulations and a familiarity with the operations and practices of the
facility to be audited. These two basic skills are a prerequisite for adequately identifying areas at the facility subject
to environmental regulations and potential regulatory violations that subtract from the organizations environmental
performance. With these basic skills, audits can be successfully conducted by persons with various educational
backgrounds (e.g., engineers, scientists, lawyers, business owners or operators). These protocols are not intended to
be a substitute for the regulations nor are they intended to be instructional to an audience seeking a primer on the
requirements under Title 40, however, they are designed to be sufficiently detailed to support the auditor's efforts.
The term "Protocol" has evolved over the years as a term of art among the professional practices of auditing and
refers to the actual working document used by auditors to evaluate facility conditions against a given set of criteria
(in this case the federal regulations). Therefore these documents describe "what" to audit a facility for rather than
"how" to conduct an audit. To optimize the effective use of these documents, you should become familiar with basic
environmental auditing practices. For more guidance on how to conduct environmental audits, U.S. EPA refers
interested parties to two well known organizations: The Environmental Auditing Roundtable (EAR) and the Institute
for Environmental Auditing (IEA).
Environmental Health and Safety Auditing Roundtable The Institute for Environmental Auditing
35888 Mildred Avenue Box 23686
North Ridgeville, Ohio 44039 L'Enfant Plaza Station
(216) 327-6605 Washington, DC 20026-3686
U.S. EPA's Public Policies that Support Environmental Auditing
In 1986, in an effort to encourage the use of environmental auditing, U.S. EPA published its "Environmental
Auditing Policy Statement" (see 51 FR 25004). The 1986 audit policy states that "it is U.S. EPA policy to
encourage the use of environmental auditing by regulated industries to help achieve and maintain compliance with
environmental laws and regulation, as well as to help identify and correct unregulated environmental hazards." In
addition, U.S. EPA defined environmental auditing as "a systematic, documented, periodic, and objective review of
facility operations and practices related to meeting environmental requirements." The policy also identified several
objectives for environmental audits:
• verifying compliance with environmental requirements,
• evaluating the effectiveness of in-place environmental management systems, and
• assessing risks from regulated and unregulated materials and practices.
In 1986, in an effort to encourage the use of environmental auditing, EPA published its "Environmental Auditing
Policy Statement" (see 51 FR 25004). The 1986 audit policy states that "it is EPA policy to encourage the use of
environmental auditing by regulated industries to help achieve and maintain compliance with environmental laws and
regulation, as well as to help identify and correct unregulated environmental hazards." In addition, EPA defined
environmental auditing as "a systematic, documented, periodic, and objective review of facility operations and
practices related to meeting environmental requirements." The policy also identified several objectives for
environmental audits:
• verifying compliance with environmental requirements,
• evaluating the effectiveness of in-place environmental management systems, and
• assessing risks from regulated and unregulated materials and practices.
In 1995, EPA published "Incentives for Serf-Policing: Discovery, Disclosure, Correction and Prevention of
Violations" - commonly known as the EPA Audit Policy - which both reaffirmed and expanded the Agency's 1986
audit policy (see 60 FR 66706 December 22, 1995). The 1995 audit policy offered major incentives for entities to
discover, disclose and correct environmental violations. On April 11, 2000, EPA issued a revised final Audit Policy
which replaces the 1995 Audit Policy (65 FR 19,617 ). The April 11, 2000 revision maintains the basic structure
This document is intended solely for guidance. No statutory or regulatory jjj
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
and terms of the 1995 Audit Policy while lengthening the prompt disclosure period to 21 days, clarifying some of its
language (including the applicability of the Policy in the acquisitions context), and conforming its provisions to
actual EPA practices. The revised audit policy continues the Agency's general practice of waiving or substantially
mitigating gravity-based civil penalties for violations discovered through an environmental audit or through a
compliance management system, provided the violations are promptly disclosed and corrected and that all of the
Policy conditions are met. On the criminal side, the revised policy continues the Agency's general practice of not
recommending that criminal charges be brought against entities that disclose violations that are potentially criminal
in nature, provided the entity meets all of the policy's conditions. The policy safeguards human health and the
environment by precluding relief for violations that cause serious environmental harm or may have presented an
imminent and substantial endangerment. The audit policy is available on the Internet at www.epa.gov/auditpol.html.
In 1996, EPA issued its "Policy on Compliance Incentives for Small Businesses" which is commonly called the
"Small Business Policy" (see 61 FR 27984 June 3, 1996). The Small Business Policy was intended to promote
environmental compliance among small businesses by providing them with special incentives to participate in
government sponsored on-site compliance assistance programs or conduct environmental audits. EPA will eliminate
or reduce penalties for small businesses that voluntarily discover, promptly disclose, and correct violations in a
timely manner.
On April 11, 2000, EPA issued its revised final Small Business Policy (see 65 FR 19630) to expand the options
allowed under the 1996 policy for discovering violations and to establish a time period for disclosure. The major
changes contained in the April 11, 2000 Small Business Policy revision include lengthening the prompt disclosure
period from 10 to 21 calendar days and broadening the applicability of the Policy to violations uncovered by small
businesses through any means of voluntary discovery. This broadening of the Policy takes advantage of the wide
range of training, checklists, mentoring, and other activities now available to small businesses through regulatory
agencies, private organizations, and the Internet.
More information on EPA's Small Business and Audit/Self-Disclosure Policies are available by contacting
EPA's Enforcement and Compliance Docket and Information Center at (202) 564-2614 or visiting the EPA
web site at: http://www.epa.gov/oeca/polguid/enfdockhtml
How to Use The Protocols
Each protocol provides guidance on key requirements, defines regulatory terms, and gives an overview of the federal
laws affecting a particular environmental management area. They also include a checklist containing detailed
procedures for conducting a review of facility conditions. The audit protocols are designed to support a wide range
of environmental auditing needs; therefore several of the protocols in this set or sections of an individual protocol
may not be applicable to a particular facility. To provide greater flexibility, each audit protocol can be obtained
electronically from the U.S. EPA Website (www.epa.gov/oeca/ccsmd/profile.html). The U.S. EPA Website offers
the protocols in a word processing format which allows the user to custom-tailor the checklists to more specific
environmental aspects associated with the facility to be audited.
The protocols are not intended to be an exhaustive set of procedures; rather they are meant to inform the auditor,
about the degree and quality of evaluation essential to a thorough environmental audit. U.S. EPA is aware that other
audit approaches may also provide an effective means of identifying and assessing facility environmental status and
in developing corrective actions.
It is important to understand that there can be significant overlap within the realm of the federal regulations. For
example, the Department of Transportation (DOT) has established regulations governing the transportation of
hazardous materials. Similarly, the Occupational Safety and Health Administration (OSHA) under the U.S.
Department of Labor has promulgated regulations governing the protection of workers who are exposed to hazardous
chemicals. There can also be significant overlap between federal and state environmental regulations. In fact, state
programs that implement federally mandated programs may contain more stringent requirements that are not
included in these protocols. There can also be multiple state agencies regulating the areas covered in these
protocols. The auditor also should determine which regulatory agency has authority for implementing an
environmental program so that the proper set of regulations is consulted. Prior to conducting the audit, the auditor
This document is intended solely for guidance. No statutory or regulatory jv
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
should review federal, state and local environmental requirements and expand the protocol, as required, to include
other applicable requirements not included in these documents.
Review of Federal Legislation and Key Compliance Requirements:
These sections are intended to provide only supplementary information or a "thumbnail sketch" of the regulations
and statutes. These sections are not intended to function as the main tool of the protocol (this is the purpose of the
checklist). Instead, they serve to remind the auditor of the general thrust of the regulation and to scope out facility
requirements covered by that particular regulation. For example, a brief paragraph describing record keeping and
reporting requirements and the associated subpart citations will identify and remind the auditor of a specific area of
focus at the facility. This allows the auditor to plan the audit properly and to identify key areas and documents
requiring review and analysis.
State and Local Regulations:
Each U.S. EPA Audit Protocol contains a section alerting the auditor to typical issues addressed in state and local
regulations concerning a given topic area (e.g., RCRA and used oil). From a practical standpoint, U.S. EPA cannot
present individual state and local requirements in the protocols. However, this section does provide general
guidance to the auditor regarding the division of statutory authority between U.S. EPA and the states over a specific
media. This section also describes circumstances where states and local governments may enact more stringent
requirements that go beyond the federal requirements.
U.S. EPA cannot overemphasize how important it is for the auditor to take under consideration the impact of state
and local regulations on facility compliance. U.S. EPA has delegated various levels of authority to a majority of the
states for most of the federal regulatory programs including enforcement. For example, most facilities regulated
under RCRA, and/or CWA have been issued permits written by the states to ensure compliance with federal and state
regulations. In turn, many states may have delegated various levels of authority to local jurisdictions. Similarly,
local governments (e.g., counties, townships) may issue permits for air emissions from the facility. Therefore,
auditors are advised to review local and state regulations in addition to the federal regulations in order to perform a
comprehensive audit.
Key Terms and Definitions:
This section of the protocol identifies terms of art used in the regulations and the checklists that are listed in the
"Definitions" sections of the Code of Federal Regulations (CFR). It is important to note that not alldefinitions from
the CFR may be contained in this section, however; those definitions which are commonly repeated in the checklists
or are otherwise critical to an audit process are included. Wherever possible, we have attempted to list these
definitions as they are written in the CFR and not to interpret their meaning outside of the regulations.
The Checklists:
The checklists delineate what should be evaluated during an audit. The left column states either a requirement
mandated by regulation or a good management practice that exceeds the requirements of the federal regulations.
The right column gives instructions to help conduct the evaluation. These instructions are performance objectives
that should be accomplished by the auditor. Some of the performance objectives may be simple documentation
checks that take only a few minutes; others may require a time-intensive physical inspection of a facility. The
checklists contained in these protocols are (and must be) sufficiently detailed to identify any area of the company or
organization that would potentially receive a notice of violation if compliance is not achieved. For this reason, the
checklists often get to a level of detail such that a specific paragraph of the subpart (e.g., 40 CFR262.34(a)(l)(i))
contained in the CFR is identified for verification by the auditor. The checklists contain the following components:
This document is intended solely for guidance. No statutory or regulatory v
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
"Regulatory Requirement or Management Practice Column"
The "Regulatory Requirement or Management Practice Column" states either a requirement mandated by
regulation or a good management practice that exceeds the requirements of the federal regulations. The
regulatory citation is given in parentheses after the stated requirement. Good management practices are
distinguished from regulatory requirements in the checklist by the acronym (MP) and are printed in italics.
"Reviewer Checks" Column:
The items under the "Reviewer Checks:" column identify requirements that must be verified to accomplish
the auditor's performance objectives. (The key to successful compliance auditing is to verify and document
site observations and other data.) The checklists follow very closely with the text in the CFR in order to
provide the service they are intended to fulfill (i.e., to be used for compliance auditing). However, they are
not a direct recitation of the CFR. Instead they are organized into more of a functional arrangement (e.g.,
record keeping and reporting requirements vs. technical controls) to accommodate an auditor's likely
sequence of review during the site visit. Wherever possible, the statements or items under the "Reviewer
Checks" column, will follow the same sequence or order of the citations listed at the end of the statement in
the "Regulatory Requirement" column.
"NOTE:" Statements
"Note:" statements contained in the checklists serve several purposes. They usually are distinguished from
"Verify" statements to alert the auditor to exceptions or conditions that may affect requirements or to
referenced standards that are not part of Title 40 (e.g., American Society for Testing and Materials (ASTM)
standards). They also may be used to identify options that the regulatory agency may choose in interacting
with the facility (e.g, permit reviews) or options the facility may employ to comply with a given
requirement.
Checklist Numbering System:
The checklists also have a unique numbering system that allows the protocols to be more easily updated by
topic area (e.g., RCRA Small Quantity Generator). Each topic area in turn is divided into control breaks to
allow the protocol to be divided and assigned to different teams during the audit. This is why blank pages
may appear in the middle of the checklists. Because of these control breaks, there is intentional repetition
of text (particularly "Note" Statements) under the "Reviewer Checks" column to prevent oversight of key
items by the audit team members who may be using only a portion of the checklist for their assigned area.
Environmental regulations are continually changing both at the federal and state level. For this reason, it is
important for environmental auditors to determine if any new regulations have been issued since the publication of
each protocol document and, if so, amend the checklists to reflect the new regulations. Auditors may become aware
of new federal regulations through periodic review of Federal Register notices as well as public information bulletins
from trade associations and other compliance assistance providers. In addition, U.S. EPA offers information on new
regulations, policies and compliance incentives through several Agency Websites. Each protocol provides specific
information regarding U.S. EPA program office websites and hotlines that can be accessed for regulatory and policy
updates.
U.S. EPA will periodically update these audit protocols to ensure their accuracy and quality. Future updates of the
protocols will reflect not only the changes in federal regulations but also public opinion regarding the usefulness of
these documents. Accordingly, the Agency would like to obtain feedback from the public regarding the format, style
and general approach used for the audit protocols. The last appendix in each protocol document contains a user
satisfaction survey and comment form. This form is to be used by U.S. EPA to measure the success of this tool and
future needs for regulatory checklists and auditing materials.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
The Relationship of Auditing to Environmental Management Systems
An environmental auditing program is an integral part of any organization's environmental management system
(EMS). Audit findings generated from the use of these protocols can be used as a basis to implement, upgrade, or
benchmark environmental management systems. Regular environmental auditing can be the key element to a high
quality environmental management program and will function best when an organization identifies the "root causes"
of each audit finding. Root causes are the primary factors that lead to noncompliance events. For example a
violation of a facility's wastewater discharge permit may be traced back to breakdowns in management oversight,
information exchange, or inadequate evaluations by untrained facility personnel.
As shown in Figure 1, a typical approach to auditing involves three basic steps: conducting the audit, identifying
problems (audit findings), and fixing identified deficiencies. When the audit process is expanded, to identify and
correct root causes to noncompliance, the organization's corrective action part of its EMS becomes more effective.
In the expanded model, audit findings (exceptions) undergo a root cause analysis to identify underlying causes to
noncompliance events. Management actions are then taken to correct the underlying causes behind the audit findings
and improvements are made to the organizations overall EMS before another audit is conducted on the facility.
Expanding the audit process allows the organization to successfully correct problems, sustain compliance, and
prevent discovery of the same findings again during subsequent audits. Furthermore, identifying the root cause of an
audit finding can mean identifying not only the failures that require correction but also successful practices that
promote compliance and prevent violations. In each case a root cause analysis should uncover the failures while
promoting the successes so that an organization can make continual progress toward environmental excellence.
Figure 1 - Expanded Corrective Action Model
Improve
Environmental
Mgmt. System
Effectiveness
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
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This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Section II
Audit Protocols
Applicability
This audit protocol applies to facilities which use, store, or handle pesticides regulated under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA). U.S. EPA has developed separate audit protocol documents that pertain to facilities
that discharge wastewaters containing pesticide chemicals and/or dispose of pesticides classified under the Resource
Conservation and Recovery Act (RCRA) as hazardous waste. Information is provided below for obtaining copies of these
documents and other compliance assistance materials available from U.S. EPA.
Not all checklist items will be applicable to a given facility. Guidance is provided in the checklist to direct the auditor to
regulations typically associated with the use, storage and handling of pesticides regulated under FIFRA.
There are numerous environmental regulatory requirements administered by federal, state, and local governments. Each level
of government may have a major impact on areas at the facility that are subject to the audit. Auditors are advised to review
federal, state and local regulations in order to perform a comprehensive audit.
Review of Federal Legislation
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was first passed in 1947, and amended numerous times,
most recently by the Food Quality Protection Act (FQPA) of 1996. FIFRA provides the U.S. EPA with the authority to
oversee, among other things, the registration, distribution, sale and use of pesticides. The Act applies to all types of
pesticides, including insecticides, herbicides, fungicides, rodenticides, and antimicrobials. FIFRA covers both intestate and
interstate commerce.
Every regulation promulgated under FIFRA affects the agricultural chemical industry in some way. The FIFRA regulations
are found in 40 CFR 152 through 186. Each part and its title are listed below.
Part 152- Pesticide Registration and Classification Procedures
Part 153- Registration Policies and Interpretations
Part 154- Special Review Procedures
Part 155- Registration Standards
Part 156- Labeling Requirements for Pesticides and Devices
Part 157- Packaging Requirements for Pesticides and Devices
Part 158- Data Requirements for Registration
Part 160- Good Laboratory Practice Standards
Part 162- State Registration of Pesticide Products
Part 163- Certification of Usefulness of Pesticide Chemicals
Part 164- Rules of Practice Governing Hearings, under FIFRA, Arising from Refusals to
Register, Cancellations of Registrations, Changes of Classifications, Suspensions
of Registrations and Other Hearings Called Pursuant to section 6 of the Act
Part 166- Exemption of Federal and State Agencies for Use of Pesticides under Emergency
Conditions
Part 167- Registration of Pesticide and Active Ingredient Producing Establishments,
Submission of Pesticide Reports
Part 168- Statements of Enforcement Policies and Interpretations
Part 169- Books and Records of Pesticide Production and Distribution
Part 170- Worker Protection Standards
Part 171- Certification of Pesticide Applicators
Part 172- Experimental Use Permits
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Part 173- Procedures Governing the Rescission of State Primary Enforcement
Responsibility for Pesticide Use Violations
Part 177- Issuance of Food Additive Regulations
Part 178- Objections and Requests for Hearings
Part 179- Formal Evidentiary Public Hearing
Part 180- Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on
Raw Agricultural Commodities
Part 185- Tolerances for Pesticides in Food
Part 186- Pesticides in Animal Feed
Additional information on FIFRA and the regulation of pesticides can be obtained from a variety of sources, including U.S.
EPA's Office of Pesticide Programs' homepage at http://www.epa.gov/pesticides, U.S. EPA's Office of Compliance,
Agriculture and Ecosystem Division at http://es.epa.gov/oeca/agecodiv.htm, or The National Agriculture Compliance
Assistance Center toll-free at 888-663-2155 or http://es.epa.gov/oeca/ag. Other sources include the National Pesticide
Telecommunications Network toll-free at 800-858-7378 and the National Antimicrobial Information Network toll-free at 800-
447-6349.
State/Local Regulations
All states have their own pesticide laws and many states have their own pesticide registration requirements. States have
primary use enforcement authority if U.S. EPA has determined that the state has adequate pesticide use laws and has adopted
adequate procedures to enforce those laws. The U.S. EPA may enter into a cooperative agreement with a state to carry out
enforcement of state laws and train and certify applicators. The FIFRA allows states to administer their own U.S. EPA-
approved applicator certifications program. Also, each state is allowed to regulate the sale and use of pesticides as long as the
regulations are at least as stringent as U.S. EPA's and the regulations do not conflict or differ from U.S. EPA's labeling and
packaging restrictions. More and more tribal governments are adopting pesticide regulations. These regulations, like state
regulations, must be considered when conducting FIFRA audits on tribal lands.
Additional information on specific state requirements can be obtained from the Association of American Pesticide Control
Officials, Inc. (AAPCO) at: http://aapco.ceris.purdue.edu/index.html. This website contains a list of state pesticide control
officials that includes contact information.
Key Compliance Requirements
Experimental Use Permits (EUP) (FIFRA sec. 5)
Any person accumulating information necessary to register a pesticide or reregister a pesticide for a use not previously
approved is required to obtain an experimental use permit (EUP). Pesticides under EUPs cannot be sold or distributed except
in limited circumstances. The application process for an experimental use permit requires the submission of extensive data
and the data required is based on the pesticide and pesticide use under consideration. Once a permit is granted, the permitee
is required to supervise and evaluate the results of testing, submit reports, and maintain extensive documentation (40 CFR
Part 172).
Pesticide Registration (FIFRA sees. 3 and 6(a)(2))
No pesticide product can be distributed or sold in the United States unless it is registered under FIFRA. The application
process for registration requires the submission of extensive data to the U.S. EPA; and, the application must be approved
prior to a product being distributed or sold in the United States. Registration is required to be amended when there is a
modification in the composition, use, labeling, or packaging of a registered product. Registrants are required to keep the U. S.
EPA informed of their current name, address, and any change of their authorized agent. When there is a transfer of the
registration, specific documentation must be submitted to the U.S. EPA and U.S. EPA approval received (40 CFR 152.15
through 152.46, 152.122 through 152.135).
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Pesticide Labeling (FIFRA sec. 2(p))
Every pesticide product is required to have label that clearly identifies contents, source, ingredients, and directions for use.
Pesticides shipped or used under an experimental use permit are required to have their own label and must include the
statement "For Experimental Use Only" (40 CFR 156.10(a) and 40 CFR 172.6).
Pesticide Producers (FIFRA sec. 2(w))
The following producers are required to be registered (40 CFR 167.20):
1. any establishment where a pesticidal product is produced, except for custom blenders;
2. any establishments where a substance is produced must be registered with U.S. EPA if the producer intends the substance
to be used as an active ingredient of a pesticide, or the producer has actual or constructive knowledge that the substance
will be used by any person as an active ingredient of a pesticide
3. any domestic establishment producing a pesticidal product for export, or any unregistered pesticide, or any foreign
establishment producing a pesticidal product for import into the United States
4. any establishment, either foreign or domestic, which produces a pesticidal product for use under an Experimental Use
Permit, FIFRA section 18 Emergency Exemption or section 24(c) Special Local Needs registration.
Producers are also required to meet reporting requirements and maintain specific records (40 CFR 167.85 and 169.2).
Pesticide Distribution
Registered pesticides must be distributed or sold only with the composition, packaging, and labeling approved by U.S. EPA.
Depending on the formulation of the pesticide, it must be distributed and sold in child-resistant packaging (40 CFR 152.130,
152.132, 157.20 through 157.36).
Pesticide Applicators
Commercial applicators and private applicators of restricted use pesticides are required to be certified. Certification is based
on the type of applications to be performed. Noncertified applicators of restricted use pesticides are required to be supervised
by certified or private commercial applicators. Applicators can be certified by U.S. EPA or by a state with an approved
certification plan (40 CFR Part 171 and applicable state regulations).
Worker Protection Standards
When applying pesticides in a greenhouse, nursery, farm, or a forest, workers are required to abide by entry restrictions and
personal protection equipment (PPE) requirements. Agricultural employers are required to notify workers of pesticide
applications and the hazards associated with those applications and provide safety training. Notification is done orally and
through the posting of signs. Agricultural employers are also required to provide decontamination supplies to workers for
washing off pesticides and pesticide residues. Pesticide handlers have to meet requirements similar to agricultural employers
(40 CFR Part 170).
Additional Concerns
In addition to the regulatory requirements promulgated under Title 40 of the CFR reflected in this checklists, assessors should
also be aware that 50 CFR 402.01 mandates that the use of pesticides must not jeopardize the existence of threatened or
endangered species. Under 7 CFR 110.3 certified applicators of restricted-use pesticides are required to keep application
records. The 19 CFR 12.112 further addresses the importation of pesticides.
Key Terms and Definitions
Accident
An unexpected, undesirable event, caused by the use or presence of a pesticide, that adversely affects man or the
environment (40 CFR 171.2).
The Act
The Federal, Insecticide, Fungicide, andRodenticide Act, as amended, 7 USC 136 et seq.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Active Ingredient
This term means (FIFRA sec.2(a) and see also 40 CFR 152.3):
1. in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which will
prevent, destroy, repel, or mitigate any pest;
2. in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of
growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;
3. in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant;
4. in the case of a dessicant, an ingredient which will artificially accelerate the drying of plant tissue; and
5. in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification,
ammonia volatilization, or decrease production through action affecting soil bacteria.
Acute Dermal LD50
A statistically derived estimate of the single dermal dose of a substance that would cause 50 percent mortality to the test
population under specified conditions (40 CFR 152.3).
Acute Inhalation LC50
A statistically derived estimate of the concentration of a substance that would cause 50 percent mortality to the test population
under specified conditions (40 CFR 152.3).
Acute Oral LDSO
A statistically derived estimate of the single oral dose of a substance that would cause 50 percent mortality to the test
population under specified conditions (40 CFR 152.3).
Administrator
The Administrator of the U.S. Environmental Protection Agency.
Adulterated
Applies to any pesticide if (FIFRA sec. 2(c)):
1. its strength or purity falls below the professed standard or quality as expressed on its labeling under which it is sold;
2. any substance has been substituted wholly or in part for the pesticide; or
3. any valuable constituent of the pesticide has been wholly or in part abstracted.
The Agency
The U.S. Environmental Protection Agency.
Agricultural Commodity
Any plant, or part thereof, or animal, or animal product, produced by a person (including farmers, ranchers, vineyardists, plant
propagators, Christmas tree growers, aquaculturists, floriculturists, orchardists, foresters, or other comparable persons)
primarily for sale, consumption, propagation, or other use by man or animals (40 CFR 171.2).
Agricultural Emergency
A sudden occurrence or set of circumstances which the agricultural employer could not have anticipated and over which the
agricultural employer has no control, and which requires entry into a treated area during a restricted-entry interval, when no
alternative practices would prevent or mitigate a substantial economic loss (40 CFR 170.112(d)).
Agricultural Employer
Any person who hires or contracts for the services of workers, for any type of compensation, to perform activities related to
the production of agricultural plants, or any person who is an owner of or is responsible for the management or condition of
an agricultural establishment that uses such workers (40 CFR 170.3).
Agricultural Establishment
Any farm, forest, nursery, or greenhouse (40 CFR 170.3).
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Agricultural Plant
Any plant grown or maintained for commercial or research purposes and includes, but is not limited to, food, feed, and fiber
plants; trees; turfgrass; flowers, shrubs; ornamentals; and seedlings (40 CFR 170.3).
Amendment Review
Review of any application requiring Agency approval to amend the registration of a currently registered product, or for which
an application is pending Agency decision, not entailing a major change to the use pattern of an active ingredient (40 CFR
152.403).
Amount of Pesticidal Product
Quantity, expressed in weight or volume of the product, and is to be reported in pounds for solid or semi-solid pesticides and
active ingredients or gallons for liquid pesticides and active ingredients, or number of individual retail units for devices (40
CFR 167.3).
Amount of Pesticide or Active Ingredient
The weight or volume of the pesticide or active ingredient used in producing a pesticide expressed as weight for solid or semi-
solid products and as weight or volume of liquid products (40 CFR 169.1)
Antimicrobial Pesticide
A pesticide that (FIFRA sec. 2(mm)):
1. is intended to:
a) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or
b) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
2. in the intended use is exempt from, or otherwise not subject to, a tolerance under section 408 of the Federal Food, Drug,
and Cosmetic Act (21 USC 346a and 348) or a food additive regulation under section 409 of such Act;
3. is not one of the following:
a) a wood preservative or antifouling paint product for which a claim of pesticidal activity other than or in addition to
an activity described in paragraph (1) is made;
b) an agricultural fungicide product; or
c) an aquatic herbicide product;
4. is any other chemical sterilant product (other than liquid chemical sterilant products exempt under FIFRA sec. 2(u)), any
other disinfectant product, any other industrial microbiocide product, and any other preservative product that is not
excluded by paragraph (3).
Applicant
A person who applies for a registration, amended registration, or reregistration, under FIFRA sec. 3 (40 CFR 152.3).
Applicant
Any person who applies for an experimental use permit, pursuant to section 5 of the Act (40 CFR 172.1).
Appropriate
When used with respect to child-resistant packaging, this term means that the packaging is chemically compatible with the
pesticide contained therein (40 CFR 157.21).
Batch
A quantity of a pesticide product or active ingredient used in producing a pesticide made in one operation or lot or if made in
a continuous or semi-continuous process or cycle, the quantity produced during an interval of time to be specified by the
producer (40 CFR 169.1)
Beneficial Organism
Any pollinating insect, or any pest predator, parasite, pathogen or other biological control agent
which functions naturally or as part of an integrated pest management program to control another pest (40 CFR 166.3).
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Biological Control Agent
Any living organism applied to or introduced into the environment that is intended to function as a pesticide against another
organism declared to be a pest by the U.S. EPA or authorized regulatory agency (40 CFR 152.3).
Calibration of Equipment
Measurement of dispersal or output of application equipment and adjustment of such equipment to control the rate of
dispersal, and droplet or particle size of a pesticide dispersed by the equipment (40 CFR 171.2).
Cooperator
Any person who grants permission to a permittee or a permittee's designated participant for the use of an experimental use
pesticide at an application site owned or controlled by the cooperator (40 CFR 172.1)
Categories of Commercial Applicators:
In relation to the certification of pesticide applicators, these include the following (40 CFR 171.3):
1. Agricultural pest control—Plant. This category includes commercial applicators using or supervising the use of restricted
use pesticides in production of agricultural crops, including without limiting the foregoing, tobacco, peanuts, cotton, feed
grains, soybeans and forage; vegetables; small fruits; tree fruits and nuts; as well as on grasslands and non-crop
agricultural lands.
2. Agricultural pest control —Animal. This category includes commercial applicators using or supervising the use of
restricted use pesticides on animals, including without limiting the foregoing, beef cattle, dairy cattle, swine, sheep,
horses, goats, poultry, and livestock, and to places on or in which animals are confined. Doctors of Veterinary Medicine
engaged in the business of applying pesticides for hire, publicly holding themselves out as pesticide applicators, or
engaged in large-scale use of pesticides are included in this category.
3. Forest pest control. This category includes commercial applicators using or supervising the use of restricted use
pesticides in forests, forest nurseries, and forest seed producing areas.
4. Ornamental and turf pest control. This category includes commercial applicators using or supervising the use of
restricted use pesticides to control pests in the maintenance and production of ornamental trees, shrubs, flowers, and turf.
5. Seed treatment. This category includes commercial applicators using or supervising the use of restricted use pesticides on
seeds.
6. Aquatic pest control. This category includes commercial applicators using or supervising the use of any restricted use
pesticide purposefully applied to standing or running water, excluding applicators engaged in public health related
activities included in category 8 below.
7. Right-of-way pest control. This category includes commercial applicators using or supervising the use of restricted use
pesticides in the maintenance of public roads, electric powerlines, pipelines, railway rights-of-way or other similar areas.
8. Industrial, institutional, structural and health related pest control. This category includes commercial applicators using
or supervising the use of restricted use pesticides in, on, or around food handling establishments, human dwellings,
institutions, such as schools and hospitals, industrial establishments, including warehouses and grain elevators, and any
other structures and adjacent areas, public or private; and for the protection of stored, processed, or manufactured
products.
9. Public health pest control. This category includes state, federal or other governmental employees using or supervising the
use of restricted use pesticides in public health programs for the management and control of pests having medical and
public health importance.
10. Regulatory pest control. This category includes state, federal or other governmental employees who use or supervise the
use of restricted use pesticides in the control of regulated pests.
11. Demonstration and research pest control. This category includes:
a) individuals who demonstrate to the public the proper use and techniques of application of restricted use pesticides or
supervise such demonstration, and
b) persons conducting field research with pesticides, and in doing so, use or supervise the use of restricted use
pesticides. Included in the first group are such persons as extension specialists and county agents, commercial
representatives demonstrating pesticide products, and those individuals demonstrating methods used in public
programs. The second group includes: state, federal, commercial and other persons conducting field research on or
utilizing restricted use pesticides.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Certified Applicator
Any individual who is certified under section 11 as authorized to use or supervise the use of any pesticide which is classified
for restricted use. Any applicator who holds or applies registered pesticides, or uses dilutions of registered pesticides
consistent with FIFRA sec. 2(ee), only to provide a service to any person so served is not deemed to be a seller or distributor
of pesticides under this Act (FIFRA sec. 2(e)(l)).
Certification
Recognition by a certifying agency that a person is competent and thus authorized to use or supervise the use of restricted use
pesticides (40 CFR 171.2).
Chemigation
The application of pesticides through irrigation systems (40 CFR 170.3).
Child-Resistant Packaging
Packaging that is designed and constructed to be significantly difficult for children under 5 years of age to open or obtain a
toxic or harmful amount of the substance contained therein within a reasonable time, and that is not difficult for normal adults
to use properly (40 CFR 157.21).
Commercial Applicator
An applicator (whether or not the applicator is a private applicator with respect to some uses) who uses or supervises the use
of any pesticide which is classified for restricted use for any purpose or on any property other than as provided in the
definition for "private applicator" (FIFRA sec. 2(e)(3) and see also 40 CFR 171.2).
Commercial Pesticide Handling Establishment
Any establishment, other than an agricultural establishment, that (40 CFR 170.3):
1. Employs any person, including a serf-employed person, to apply on an agricultural establishment, pesticides used in the
production of agricultural plants.
2. Employs any person, including a serf-employed person, to perform on an agricultural establishment, tasks as a crop
advisor.
Compatibility
That property of a pesticide which permits its use with other chemicals without undesirable results being
caused by the combination (40 CFR 171.2).
Competent
Properly qualified to perform functions associated with pesticide application, the degree of capability required being directly
related to the nature of the activity and the associated responsibility (40 CFR 171.2).
Common Exposure Route
A likely way (oral, dermal, respiratory) by which a pesticide may reach and/or enter an organism (40 CFR 171.2).
Containment and Inactivation Controls
Any combination of mechanical, procedural, or biological controls designed and operated to restrict environmental release of
viable microorganisms from a facility (40 CFR 172.43).
Crisis Exemption
This is utilized in an emergency condition when the time from discovery of the emergency to the time when the pesticide use
needed is insufficient to allow for the authorization of a specific quarantine exemption or public health exemption (40 CFR
166.2).
Crop Advisor
Any person who is assessing pest numbers or damage, pesticide distribution, or the status or requirements of agricultural
plants. The term does not include any person who is performing hand labor tasks (40 CFR 170.3).
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Current Production [Sales or Distribution]
Amount of planned production in the calendar year in which the pesticides report is submitted, including new pesticidal
products not previously sold or distributed (40 CFR 167.3).
Custom Blender
Any establishment which provides the service of mixing pesticides to a customer's specifications, usually a pesticide(s)-
fertilizer(s), pesticide-pesticide, or a pesticide-animal feed mixture, when: (1) The blend is prepared to the order of the
customer and is not held in inventory by the blender; (2) the blend is to be used on the customer's property (including leased
or rented property); (3) the pesticide(s) used in the blend bears end-use labeling directions which do not prohibit use of the
product in such a blend; (4) the blend is prepared from registered pesticides; (b) the blend is delivered to the end-user along
with a copy of the end-use labeling of each pesticide used in the blend and a statement specifying the composition of mixture;
and (6) no other pesticide production activity is performed at the establishment (40 CFR 167.3).
Data Gap
The absence of any valid study or studies in the Agency's files which would satisfy a specific data requirement for a
particular pesticide product (40 CFR 152.83).
Data Submitters List
The current Agency list, entitled "Pesticide Data Submitters by Chemical," of persons who have submitted data to the Agency
(40 CFR 152.83).
Dealership
Any site owned or operated by a restricted use pesticide retail dealer where any restricted use pesticide is made available for
use, or where the dealer offers to make available for use any such pesticide (40 CFR 171.2).
Deliberately Modified
The directed addition, rearrangement, or removal of nucleotide sequences to or from genetic material (40 CFR 172.43).
Device
Any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any
pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in
living man or other living animals); but not including equipment used for the application of pesticides when sold separately
therefrom (FIFRA sec. 2(h), and see also 40 CFR 167.3 and 40 CFR 169.1).
Dietary LCSO
A statistically derived estimate of the concentration of a test substance in the diet that would cause 50 percent mortality to the
test population under specified conditions (40 CFR 152.161).
Distribute(-d)(-tion) or Sell (Sold) (Sale)
The acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or
receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any state (40
CFR 152.3).
Early Entry
Entry by a worker into a treated area on the agricultural establishment after a pesticide application is complete, but before any
restricted-entry interval for the pesticide has expired (40 CFR 170.3).
Emergency Condition
An urgent, non-routine situation that requires the use of a pesticide(s) and shall be deemed to exist when (40 CFR 166.3):
1. No effective pesticides are available under the Act that have labeled uses registered for control of the pest under the
conditions of the emergency; and
2. No economically or environmentally feasible alternative practices which provide adequate control are available;
3. The situation:
a) Involves the introduction or dissemination of a pest new to or not theretofore known to be widely prevalent or
distributed within or throughout the United States and its territories; or
This document is intended solely for guidance. No statutory or regulatory 8
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
b) Will present significant risks to human health; or
c) Will present significant risks to threatened or endangered species, beneficial organisms, or the environment; or
d) Will cause significant economic loss due to:
i) An outbreak or an expected outbreak of a pest; or
ii) A change in plant growth or development caused by unusual environmental conditions where such change can
be rectified by the use of a pesticide(s).
End Use Product
A pesticide product whose labeling (40 CFR 152.3):
1. Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances)
for controlling pests or defoliating, desiccating, or regulating the growth of plants, and
2. Does not state that the product may be used to manufacture or formulate other pesticide products.
Environment
Water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these
(FIFRA sec. 2(j) and see also 40 CFR 171.2).
Establishment
Any place where a pesticide or device or active ingredient used in producing a pesticide is produced, or held, for distribution
in sale (FIFRA sec. 2(dd) and see also 40 CFR 167.3).
Excepted Agricultural Applications for Handler Standards
40 CFR 170.202 through 170.260 does not apply when any pesticide is applied on an agricultural establishment in the
following circumstances (40 CFR 170.203):
1. for mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored
by governmental entities;
2. on livestock or other animals, or in or about animal premises;
3. on plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and
vegetable gardens, and home greenhouses;
4. on plants that are in ornamental gardens, parks, and public or private lawns and grounds that are intended only for
aesthetic purposes or climatic modification;
5. in a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest
control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use;
6. for control of vertebrate pests;
7. as attractants or repellents in traps;
8. on the harvested portions of agricultural plants or on harvested timber; and
9. for research uses of unregistered pesticides.
Excepted Agricultural Applications for Worker Standards
40 CFR 170.102 through 170.160 does not apply when any pesticide is applied on an agricultural establishment in the
following circumstances (40 CFR 170.103):
1. for mosquito abatement, Mediterranean fruit fly eradication, or similar wide-area public pest control programs sponsored
by governmental entities;
2. on livestock or other animals, or in or about animal premises;
3. on plants grown for other than commercial or research purposes, which may include plants in habitations, home fruit and
vegetable gardens, and home greenhouses;
4. on plants that are in ornamental gardens, parks, and public or private lawns and grounds that are intended only for
aesthetic purposes or climatic modification;
5. by injection directly into agricultural plants, except this does not include "hack and squirt," "frill and spray,"
chemigation, soil-incorporation, or soil-injection;
6. in a manner not directly related to the production of agricultural plants, including, but not limited to, structural pest
control, control of vegetation along rights-of-way and in other noncrop areas, and pasture and rangeland use;
7. for control of vertebrate pests;
8. as attractants or repellents in traps;
9. on the harvested portions of agricultural plants or on harvested timber; and
This document is intended solely for guidance. No statutory or regulatory 9
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
10. for research uses of unregistered pesticides.
Exclusive Use Study
A study that meets each of the following requirements (provided that, a study is an exclusive use study only during the 10-
year period following the date of the first registration) (40 CFR 152.83):
1. The study pertains to a new active ingredient (new chemical) or new combination of active ingredients (new
combination) first registered after September 30, 1978;
2. The study was submitted in support of, or as a condition of approval of, the application resulting in the first registration
of a product containing such new chemical or new combination (first registration), or an application to amend such
registration to add a new use; and
3. The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B).
Experimental Animals
Individual animals or groups of animals, regardless of species, intended for use and used solely for research purposes and
does not include animals intended to be used for any food purposes (40 CFR 172.1).
Experimental Use Permit Review
Review of an application for a permit pursuant to section 5 of FIFRA to apply a limited quantity of a pesticide in order to
accumulate information necessary to register the pesticide. The application may be for a new chemical or for a new use of an
old chemical. The fee applies to such experimental uses of a single unregistered active ingredient (no limit on the number of
other active ingredients, in a tank mix, already registered for the crops involved) and no more than three crops. This fee does
not apply to experimental use permits required for small-scale field testing of microbial pest control agents (40 CFR 152.403).
Farm
Any operation, other than a nursery or forest, engaged in the outdoor production of agricultural plants (40 CFR 170.3).
Final Printed Labeling
The label or labeling of the product when distributed or sold. Final printed labeling does not include the package
of the product, unless the labeling is an integral part of the package (40 CFR 152.3).
First Food Use
The use of a pesticide on a food or in a manner which otherwise would be expected to result in residues in a food, if no
permanent tolerance, exemption from the requirement of a tolerance, or food additive regulation for residues of
the pesticide on any food has been established for the pesticide under section 408 (d) or (e) or 409 of the Federal Food, Drug,
and Cosmetic Act (FFDCA) (40 CFR 166.3).
Food
Any article used for food or drink for man or animals (40 CFR 166.3).
Forest
A concentration of trees and related vegetation in non-urban areas sparsely inhabited by and infrequently used by humans;
characterized by natural terrain and drainage patterns (40 CFR 171.2).
Forest
Any operation engaged in the outdoor production of any agricultural plant to produce wood fiber or timber products (40 CFR
170.3)
Fumigant
Any pesticide product that is a vapor or gas or forms a vapor or gas on application and whose method of pesticidal action is
through the gaseous state (40 CFR 156.203 and 40 CFR 170.3).
Greenhouse
Any operation engaged in the production of agricultural plants inside any structure or space that is enclosed with nonporous
covering and that is of sufficient size to permit worker entry. This term includes, but is not limited to, polyhouses, mushroom
houses, rhubarb houses, and similar structures. It does not include such structures as malls, atriums, conservatories,
This document is intended solely for guidance. No statutory or regulatory 10
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
arboretums, or office buildings where agricultural plants are present primarily for aesthetic or climatic modification (40 CFR
170.3).
Hand Labor
Any agricultural activity performed by hand or with hand tools that causes a worker to have substantial contact with
surfaces (such as plants, plant parts, or soil) that may contain pesticide residues. These activities include, but are not limited
to, harvesting, detasseling, thinning, weeding, topping, planting, sucker removal, pruning, disbudding, roguing, and packing
produce into containers in the field. Hand labor does not include operating, moving, or repairing irrigation or watering
equipment or performing the tasks of crop advisors (40 CFR 170.3).
Handler
Any person, including a serf-employed person (40 CFR 170.3):
1. Who is employed for any type of compensation by an agricultural establishment or commercial pesticide handling
establishment to which 40 CFR 170.202 to 170.260 apply and who is:
a) Mixing, loading, transferring, or applying pesticides.
b) Disposing of pesticides or pesticide containers.
c) Handling opened containers of pesticides.
d) Acting as a flagger.
e) Cleaning, adjusting, handling, or repairing the parts of mixing, loading, or application equipment that may contain
pesticide residues.
f) Assisting with the application of pesticides.
g) Entering a greenhouse or other enclosed area after the application and before the inhalation exposure level listed in
the labeling has been reached or one of the ventilation criteria established by 40 CFR 170.110(c)(3) or in the labeling
has been met:
i) To operate ventilation equipment.
ii) To adjust or remove coverings used in fumigation.
iii) To monitor air levels.
h) Entering a treated area outdoors after application of any soil fumigant to adjust or remove soil coverings such
as tarpaulins.
i) Performing tasks as a crop advisor:
i) During any pesticide application.
ii) Before the inhalation exposure level listed in the labeling has been reached or one of the ventilation criteria
established by 40 CFR 170.110(c)(3) or in the labeling has been met.
iii) During any restricted-entry interval.
2. The term does not include any person who is only handling pesticide containers that have been emptied or cleaned
according to pesticide product labeling instructions or, in the absence of such instructions, have been subjected to triple-
rinsing or its equivalent.
Handler Employer
Any person who is self-employed as a handler or who employs any handler, for any type of compensation (40 CFR 170.3).
Hazard
A probability that a given pesticide will have an adverse effect on man or the environment in a given situation, the relative
likelihood of danger or ill effect being dependent on a number of interrelated factors present at any given time (40 CFR
171.2).
Host
Any plant or animal on or in which another lives for nourishment, development, or protection (40 CFR 171.2).
Immediate Family
Includes only spouse, children, stepchildren, foster children, parents, stepparents, foster parents, brothers, and
sisters (40 CFR 170.3).
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Inability
The incapacity of any person to maintain, furnish or permit access to any records under this Act and regulations, where such
incapacity arises out of causes beyond the control and without the fault or negligence of such person. Such causes may
include, but are not restricted to acts of God or of the public enemy, fires, floods, epidemics, quarantine restrictions, strikes,
and unusually severe weather, but in every case, the failure must be beyond the control and without the fault or negligence of
said person (40 CFR 169.1).
Inert Ingredient
An ingredient which is not active (see definition for active ingredient) (FIFRA sec. 2(m) and see also 40 CFR 152.3).
Institutional Use
Any application of a pesticide in or around any property or facility that functions to provide a service to the general public or
to public or private organizations, including but not limited to (40 CFR 152.3):
1. Hospitals and nursing homes.
2. Schools other than preschools and day care facilities.
3. Museums and libraries.
4. Sports facilities.
5. Office buildings.
Introduction of Genetic Material
The movement of nucleotide sequences into a microorganism, regardless of the technique used (40 CFR 172.43).
Inversions of Genetic Material
The replacement of an internal section of a chromosome in the reverse orientation (40 CFR 172.43).
Label
The written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers (FIFRA
sec. 2(p)(l)).
Labeling
All labels and all other written, printed, or graphic matter (FIFRA sec. 2(p)(2)):
1. accompanying the pesticide or device at any time; or
2. to which reference is made on the label or in literature accompanying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the
Department of Health and Human Services, state experiment stations, state agricultural colleges, and other similar federal
or state institutions or agencies authorized by law to conduct research in the field of pesticides.
Maintenance Applicator
Any individual who, in the principal course of such individual's employment, uses, or supervises the use of, a pesticide not
classified for restricted use (other than a ready to use consumer products pesticide); for the purpose of providing structural
pest control or lawn pest control including janitors, general maintenance personnel, sanitation personnel, and grounds
maintenance personnel. The term 'maintenance applicator' does not include private applicators as defined in FIFRA section
2(e)(2); individuals who use antimicrobial pesticides, sanitizers or disinfectants; individuals employed by federal, state, and
local governments or any political subdivisions thereof, or individuals who use pesticides not classified for restricted use in or
around their homes, boats, sod farms, nurseries, greenhouses, or other noncommercial property (FIFRA sec. 2(jj)).
Make Available for Use
To distribute, sell, ship, deliver for shipment, or receive and (having so received) deliver, to any person. However, the term
excludes transactions solely between persons who are pesticide producers, registrants, wholesalers, or retail sellers, acting
only in those capacities (40 CFR 171.2).
Management Practice (MP)
Practices that, although not mandated by law, are encouraged to promote safe operating procedures.
This document is intended solely for guidance. No statutory or regulatory 12
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Manufacturing Use Product
Any pesticide product that is not an end-use product (40 CFR 152.3).
Microbial Pesticide
Any pesticide whose active ingredient is a microorganism intended for preventing, destroying, repelling, or mitigating any
pest, or intended for use as a plant regulator, defoliant, or desiccant (40 CFR 172.43).
Microbial Pesticides Resulting From Rearrangements
A microbial pesticide resulting from translocations or inversions of genetic material (40 CFR 172.43).
Microorganism
A bacterium, fungus, alga, virus, or protozoan (40 CFR 172.43).
Misbranded
A pesticide is misbranded if (FIFRA sec. 2(q)):
1. its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or
misleading in any particular;
2. it is contained in a package or other container or wrapping which does not conform to the standards established by the
Administrator pursuant to section 25(c)(3) of FIFRA;
3. it is an imitation of, or is offered for sale under the name of, another pesticide;
4. its label does not bear the registration number assigned under section 7 of FIFRA to each establishment in which it was
produced;
5. any word, statement, or other information required by or under authority of FIFRA to appear on the label or labeling is
not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or
graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
6. the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which
the product is intended and if complied with, together with any requirements imposed under section 3 (d) of the Act, are
adequate to protect health and the environment;
7. the label does not contain a warning or caution statement which may be necessary and if complied with, together with any
requirements imposed under section 3(d) of this Act, is adequate to protect health and the environment; or
8. in the case of a pesticide not registered in accordance with section 3 of this Act and intended for export, the label does
not contain, in words prominently placed thereon with such conspicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under customary
conditions of purchase and use, the following: "Not Registered for Use in the United States of America."
A pesticide is misbranded if:
1. the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or
wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot
be clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is not
misbranded under this subparagraph if:
a) the size or form of the immediate container, or the outside container or wrapper of the retail package, makes it
impracticable to place the ingredient statement on the part which is presented or displayed under customary
conditions of purchase; and
b) the ingredient statement appears prominently on another part of the immediate container, or outside container or
wrapper, permitted by the Administrator;
2. the labeling does not contain a statement of the use classification under which the product is registered;
3. there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through
which the required information on the immediate container cannot be clearly read, a label bearing:
a) the name and address of the producer, registrant, or person for whom produced;
b) the name, brand, or trademark under which the pesticide is sold;
c) the net weight or measure of the content, except that the Administrator may permit reasonable variations; and
d) when required by regulations of the Administrator to effectuate the purposes of this Act, the registration number
assigned to the pesticide under this Act, and the use classification; and
This document is intended solely for guidance. No statutory or regulatory 13
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
4. the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in
addition to any other matter required by this Act:
a) the skull and crossbones;
b) the word "poison" prominently in red on a background of distinctly contrasting color; and
c) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.
New Biochemical and Microbial Registration Review
Review of an application for registration of a biochemical or microbial pesticide product containing a biochemical or
microbial active ingredient not contained in any other pesticide product that is registered under FIFRA at the time the
application is made. For purposes of Subpart U of 40 CFR 152, the definitions of biochemical and microbial pesticides
contained in 40 CFR 158.65 (a) and (b) apply (40 CFR 152.403).
New Chemical
An active ingredient not contained in any currently registered pesticide (40 CFR 166.3).
New Chemical Registration Review
Review of an application for registration of a pesticide product containing a chemical active ingredient which is not contained
as an active ingredient in any other pesticide product that is registered under FIFRA at the time the application is made (40
CFR 152.403).
New Use (When Used with Respect to a Product Containing a Particular Active Ingredient)
1. Any proposed use pattern that would require the establishment of, the increase in, or the exemption from the requirement
of, a tolerance or food additive regulation under section 408 or 409 of the Federal Food, Drug, and Cosmetic Act
(FFDCA);
2. Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently
registered for that use pattern; or
3. Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of
exposure, to the active ingredient of man or other organisms (40 CFR 152.3).
New Use Pattern Registration Review
Review of an application for registration, or for amendment of a registration entailing a major change to the use pattern of an
active ingredient contained in a product registered under FIFRA or pending Agency decision on a prior application at the time
of application. For purposes of this paragraph, examples of major changes include but are not limited to, changes from non-
food to food use, outdoor to indoor use, ground to aerial application, terrestrial to aquatic use, and non-residential to
residential use (40 CFR 152.403).
Nonindigenous Microbial Pesticide
A microbial pesticide brought into one of the following geographic areas from outside that area (40 CFR 172.43):
1. The continental United States, including Alaska, and the immediately adjoining countries (i.e., Canada and Mexico).
2. The Hawaiian Islands.
3. The Caribbean Islands including Puerto Rico and the U.S. Virgin Islands.
Non-Target Organism
A plant or animal other than the one against which the pesticide is applied (40 CFR 171.2).
Nursery
Any operation engaged in the outdoor production of any agricultural plant to produce cut flowers and ferns or plants that will
be used in their entirety in another location. Such plants include, but are not limited to, flowering and foliage plants or trees;
tree seedlings; live Christmas trees; vegetable, fruit, and ornamental transplants; and turfgrass produced for sod (40 CFR
170.3).
Old Chemical Registration Review
Review of an application for registration of a new product containing active ingredients and uses which are substantially
similar or identical to those currently registered or for which an application is pending Agency decision (40 CFR 152.403).
This document is intended solely for guidance. No statutory or regulatory 14
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Operated By the Same Producer (When Used with Respect to Two Establishments)
Each such establishment is either owned by, or leased for operation by and under the control of, the same person. The term
does not include establishments owned or operated by different persons, regardless of contractual agreement between such
persons (40 CFR 152.3).
Original Data Submitter
The person who possesses all rights to exclusive use or compensation under FIFRA section 3(c)(l)(D) in a study originally
submitted in support of an application for registration, amended registration, reregistration, or experimental use permit, or to
maintain an existing registration in effect. The term includes the person who originally submitted the study, any person to
whom the rights under FIFRA section 3(c)(l)(D) have been transferred, or the authorized representative of a group of joint
data developers (40 CFR 152.83).
Ornamental
Trees, shrubs, and other plantings in and around habitations generally, but not necessarily located in urban and suburban
areas, including residences, parks, streets, retail outlets, industrial and institutional buildings (40 CFR 171.2).
Outdoor Use
Any pesticide application that occurs outside enclosed manmade structures or the consequences of which extend beyond
enclosed manmade structures, including, but not limited to, pulp and paper mill water treatments and industrial cooling water
treatments (40 CFR 152.161).
Owner
Any person who has a present possessory interest (fee, leasehold, rental, or other) in an agricultural establishment covered by
40 CFR Part 170. A person who has both leased such agricultural establishment to another person and granted that same
person the right and full authority to manage and govern the use of such agricultural establishment is not an owner for
purposes of 40 CFR Part 170 (40 CFR 170.3).
Package or Packaging
The immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution,
sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or
delivering the pesticide unless it is the only such package (40 CFR 152.3 and 40 CFR 157.21).
Participant
Any person acting as a representative of the permittee and responsible for making available for use, or supervising the use or
evaluation of, an experimental use pesticide to be applied at a specific application site (40 CFR 172.1).
Past Year
The calendar year immediately prior to that in which the report is submitted (40 CFR 167.3).
Personal Protective Equipment (PPE)
Devices and apparel that are worn to protect the body from contact with pesticides or pesticide residues, including, but not
limited to, coveralls, chemical-resistant suits, chemical-resistant gloves, chemical-resistant footwear, respiratory protection
devices, chemical-resistant aprons, chemical-resistant headgear, and protective eyewear (40 CFR 170.112(c)(4)(i)).
Pest
Any insect, rodent, nematode, fungus, weed, or any other form of terrestrial or aquatic plant or animal life or virus, bacteria,
or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which
the Administrator declares to be a pest under section 25(c)(l) of FIFRA (FIFRA sec. 2(t) and see also 40 CFR 152.5).
Pesticidal Product
A pesticide, active ingredient, or device (40 CFR 167.3).
Pesticidal Product Report
Information showing the types and amounts of pesticidal products which were: (1) Produced in the past calendar year; (2)
produced in the current calendar year; and, (3) sold or distributed in the past calendar year. For active ingredients, the
This document is intended solely for guidance. No statutory or regulatory 15
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
pesticidal product report must include information on the types and amounts of an active ingredient for which there is actual
or constructive knowledge of its use or intended use as a pesticide. This pesticidal product report also pertains to those
products produced for export only which must also be reported. A positive or a negative annual report is required in order to
maintain registration for the establishment (40 CFR 167.3).
Pesticide
Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest;
any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant; and
any nitrogen stabilizer, except that the term "pesticide" shall not include any article that is a "new animal drug" within the
meaning of section 201(w) of the Federal Food, Drug, and Cosmetic Act (21 USC 321(w)), that has been determined by the
Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the
article, or that is an animal feed within the meaning of section 201(x) of such Act (21 USC 321(x)) bearing or containing a
new animal drug. The term "pesticide" does not include liquid chemical sterilant products (including any sterilant or
subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 USC 321). For purposes of the preceding sentence, the term "critical device"
includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or
normally sterile areas of the body and the term "semi-critical device" includes any device which contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body
(FIFRA sec. 2(u), and see also 40 CFR 152.3, 40 CFR 152.8, and 40 CFR 152.10).
Pesticide Product
A pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to
be, distributed or sold. This includes any physical apparatus used to deliver or apply the pesticide if distributed or sold with
the pesticide (40 CFR 152.3).
Practicable
When used with respect to child-resistant packaging, this term means that the packaging can be mass produced and can be
used in assembly line production (40 CFR 157.21).
Practical Knowledge
The possession of pertinent facts and comprehension together with the ability to use them in dealing with specific problems
and situations (40 CFR 171.2).
Principal Place of Business
The principal location, either residence or office, in the state in which an individual, partnership, or corporation applies
pesticides (40 CFR 171.2).
Private Applicator
A certified applicator who uses or supervises the use of any pesticide which is classified for restricted use for purposes of
producing any agricultural commodity on property owned or rented by the applicator or the applicator's employer or (if
applied without compensation other than trading of personal services between producers of agricultural commodities) on the
property of another person (FIFRA sec. 2(ee)(2)).
Produce
To manufacture, prepare, compound, propagate, or process any pesticide or device or active ingredient used in producing a
pesticide. (FIFRA sec. 2 (w) and see also 40 CFR 167.3).
Producer
The person who manufactures, prepares, compounds, propagates, or processes any pesticide or device or active ingredient
used in producing a pesticide. The dilution by individuals of formulated pesticides for their own use and according to the
directions on registered labels shall not of itself result in such individuals being included in the definition of "producer" for
the purposes of FIFRA (FIFRA sec. 2(w) and see also 40 CFR 167.3).
Protective Equipment
Clothing or any other materials or devices that shield against unintended exposure to pesticides (40 CFR 171.2).
This document is intended solely for guidance. No statutory or regulatory 16
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Public Health Exemption
This may be authorized in an emergency condition to control a pest that will cause a significant risk to human health (40 CFR
166.2).
Public Health Pesticide
Any minor use pesticide product registered for use and used predominantly in public health programs for vector control or for
other recognized health protection uses, including the prevention or mitigation of viruses, bacteria, or other microorganisms
(other than viruses, bacteria, or other microorganisms on or in living man or other living animal) that pose a threat to public
health (FIFRA sec. 2(nn)).
Quarantine Exemption
This may be authorized in an emergency condition to control the introduction or spread of any pest new to or not theretofore
known to be widely prevalent or distributed within and throughout the United States and its territories (40 CFR 166.2).
Registrant
A person who has registered any pesticide pursuant to the provisions of this Act (FIFRA sec. 2(y)).
Regulated Pest
A specific organism considered by a state or federal agency to be a pest requiring regulatory restrictions, regulations, or
control procedures in order to protect the host, man and/or his environment (40 CFR 171.2).
Residential Use
Use of a pesticide directly (40 CFR 152.3):
1. On humans or pets,
2. In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited
to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or
3. In any preschool or day care facility.
Residential Use
Use of a pesticide or device (40 CFR 157.21):
1. Directly on humans or pets;
2. In, on, or around any structure, vehicle, article, surface or area associated with the household, including but not limited to
areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles; or
3. In or around any preschool or day care facility.
Restricted-Entry Interval
The time after the end of a pesticide application during which entry to the treated area is restricted (40 CFR 156.203 and 40
CFR 170.3).
Restricted-Use Pesticides
Pesticides designated for restricted use under the provisions of Section 3(d)(l)(C) of FIFRA (40 CFR 171.2).
Restricted-Use Pesticide Retail Dealer
Any person who makes available for use any restricted use pesticide, or who offers to make available for use any such
pesticide (40 CFR 171.2).
Service Technician
Any individual who uses or supervises the use of pesticides (other than a ready to use consumer products pesticide) for the
purpose of providing structural pest control or lawn pest control on the property of another for a fee. The term "service
technician" does not include individuals who use antimicrobial pesticides, sanitizers or disinfectants; or who otherwise apply
ready to use consumer products pesticides.
This document is intended solely for guidance. No statutory or regulatory 17
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Single Genome
The sum total of chromosomal and extrachromosomal genetic material of an isolate and any descendants derived under axenic
culture conditions from that isolate (40 CFR 172.43).
Small-Scale Test
The experimental use of a microbial pesticide in a facility such as a laboratory or greenhouse, or use in limited replicated field
trials or other tests as described in 40 CFR 172.3(c) (40 CFR 172.43).
Sold or Distributed
The aggregate amount of a pesticidal product released for shipment by the establishment in which the pesticidal product was
produced (40 CFR 167.3).
Significant Economic Loss
Under the emergency conditions: for a productive activity, the profitability would be substantially below the expected
profitability for that activity; or, for other types of activities, where profits cannot be calculated, the value of public or private
fixed assets would be substantially below the expected value for those assets. Only losses caused by the emergency
conditions, specific to the impacted site, and specific to the geographic area affected by the emergency conditions are
included. The contribution of obvious mismanagement to the loss will not be considered in determining loss. In evaluating the
significance of an economic loss for productive activities, the Agency will consider whether the expected reduction in
profitability exceeds what would be expected as a result of normal fluctuations over a number of years, and whether the loss
would affect the long-term financial viability expected from the productive activity. In evaluating the significance of an
economic loss for situations other than productive activities, the Agency will consider reasonable measures of expected loss
(40 CFR 166.3).
Special Review
Any interim administrative review of the risks and benefits of the use of a pesticide conducted pursuant to the provisions of
EPA's Rebuttable Presumption Against Registration rules, 40 CFR 162.1 l(a), or any subsequent version of those rules (40
CFR 166.3).
Specific Exemption
This exemption may be authorized in an emergency condition to avert (40 CFR 166.2):
1. a significant economic loss
2. a significant risk to endangered species, threatened species, beneficial organisms, or the environment.
Standard
The measure of knowledge and ability which must be demonstrated as a requirement for certification (40 CFR 171.2).
Substantial Economic Loss
A loss in profitability greater than that which would be expected based on the experience and fluctuations of
crop yields in previous years. Only losses caused by the agricultural emergency specific to the affected site and geographic
area are considered. The contribution of mismanagement cannot be considered in determining the loss (40 CFR 170.112(d)).
Supplemental Distribution
The distribution or sale of a registered product by the registrant under another person's name and address. The distributor is
considered the agent of the registrant for all intents and purposes under FIFRA (40 CFR 152.132).
Technically Feasible
When applied to child-resistant packaging, means that the technology exists to produce the child-resistant packaging for a
particular pesticide (40 CFR 157.21).
Susceptibility
The degree to which an organism is affected by a pesticide at a particular level of exposure (40 CFR 171.2).
This document is intended solely for guidance. No statutory or regulatory 18
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Test or Testing
Any use of a microbial pesticide consistent with section 5 of the Act, including limited replicated field trials and associated
activities (40 CFR 172.43).
To Distribute or Sell
To distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment, ship, deliver for shipment, release for
shipment, or receive and (having so received) deliver or offer to deliver. The term does not include the holding or application
of registered pesticides or use dilutions thereof by any applicator who provides a service of controlling pests without
delivering any unapplied pesticide to any person so served (FIFRA sec. 2(gg)).
Toxicity
The property of a pesticide to cause any adverse physiological effects (40 CFR 171.2).
Toxicity Categories
Required warnings and precautionary statements are based on the toxicity category of the pesticide. The category is assigned
on the basis of the highest hazard shown in the table listed in 40 CFR 156.10 (40 CFR 156.10(h)).
Translocations of Genetic Material
A chromosomal configuration in which part of a chromosome becomes attached to a different chromosome, or inserts in a
different location on the same chromosome (40 CFR 172.43).
Treated Area
Any area to which a pesticide is being directed or has been directed (40 CFR 170.3).
Type of Pesticidal Product
This refers to each individual product as identified by: the product name; U.S. EPA Registration Number (or U.S. EPA File
Symbol, if any, for planned products, or Experimental Permit Number, if the pesticide is produced under an Experimental Use
Permit); active ingredients; production type (technical, formulation, repackaging, etc.); and, market for which the product was
produced (domestic, foreign, etc.). In cases where a pesticide is not registered, registration is not applied for, or the pesticide
is not produced under an Experimental Use Permit, the term shall also include the chemical formulation (40 CFR 167.3).
Uncertified Person
Any person who is not holding a currently valid certification document indicating that he is certified under section 4 of FIFRA
in the category of the restricted use pesticide made available for use (40 CFR 171.2).
Under the Direct Supervision Of
The act or process whereby the application of a pesticide is made by a competent person acting under the instructions and
control of a certified applicator who is responsible for the actions of that person and who is available if and when needed,
even though such certified applicator is not physically present at the time and place the pesticide is applied (40 CFR 171.2).
Unit Packaging
A package that is labeled with directions to use the entire contents of the package in a single application (40 CFR 157.21).
Unreasonable Adverse Effects on the Environment
Any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and
benefits of the use of any pesticide (40 CFR 166.3).
Valid Study
A study that has been conducted in accordance with the Good Laboratory Practice standards of 40 CFR Part 160 or generally
accepted scientific methodology and that U.S. EPA has not determined to be invalid (40 CFR 152.83).
Value for Pesticide Purposes
That characteristic of a substance or mixture of substances which produces an efficacious action on a pest (40 CFR 172.1).
This document is intended solely for guidance. No statutory or regulatory 19
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Worker
Any person, including a self-employed person, who is employed for any type of compensation and who is performing
activities relating to the production of agricultural plants on an agricultural establishment to which subpart B of this part
applies. While persons employed by a commercial pesticide handling establishment are performing tasks as crop advisors,
they are not workers covered by the requirements of Subpart B of 40 CFR Part 170 (40 CFR 170.3).
Typical Records To Review
• Records of pesticides purchased (purchase orders, inventory)
• Pesticide application records
• Description of the pest control program
• Certification status of pesticide applicators
• Pesticide disposal manifests
• Contract files
• Recent ventilation rating for pesticide fume hood and pesticide mixing/storage areas
Typical Physical Features To Inspect
• Personnel protection equipment
• Pesticide application equipment
• Pesticide storage areas, including storage containers
List of Acronyms and Abbreviations
CFR Code of Federal Regulations
EPA Environmental Protection Agency
ESA Endangered Species Act
EUP Experimental Use Permit
FFDCA Federal Food, Drug and Cosmetic Act
FIFRA The Federal Insecticide, Fungicide, and Rodenticide Act
FR Federal Register
ft Foot
g Gram
gal Gallon
h Hours
in. Inch
kg Kilogram
L Liter
Ib Pound
mg Milligram
mi Mile
MP Management Practice
NIH National Institute of Health
NOI Notice of Intent
NOV Notice of Violation
PM Pesticides Management
PPE Personal Protective Equipment
RCRA Resource Conservation and Recovery Act
REI Restricted-Entry Interval
SCBA Serf-Contained Breathing Apparatus
USDA U.S. Department of Agriculture
This document is intended solely for guidance. No statutory or regulatory 20
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
USC U.S. Code
yr Year
This document is intended solely for guidance. No statutory or regulatory 21
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Index for Checklist Users
Categories
General
Experimental Use Permits
Pesticide Registration
Pesticide Labeling
Restricted Use Pesticides
Pesticide Production, Distribution, and Packaging
(includes Records Maintenance)
Pesticide Applicators
Agricultural Pesticides
Entry Level Restrictions
Worker Notification and Training
Operations
Pesticide Handlers
Refer To:
Checklist Item
PM. 1.1 through PM. 1.3
PM.10.1 through PM. 10.4
PM.20.1 through PM.20.6
PM.30.1 through PM.30.3
PM.40.1andPM.40.2
PM.50.1 through PM.50.7
PM.60.1 through PM.60.3
PM.70.1 through PM.70. 11
PM. 80.1 through PM. 80.7
PM.90.1andPM.90.2
PM. 120.1 through PM. 120. 10
Page Number:
25
27
33
39
43
45
55
57
63
73
77
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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This document is intended solely for guidance. No statutory or regulatory 24
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Checklist
COMPLIANCE CATEGORY:
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGMENT
PRACTICE
REVIEWER CHECKS
PM.1
GENERAL
PM.1.1. The current status of
any ongoing or unresolved
consent orders, compliance
agreements, notice of
violations (NOVs), inter-
agency agreements, or
equivalent state enforcement
actions is required to be
examined.
Determine if noncompliance issues have been resolved by reviewing a copy of the
previous report, consent orders, compliance agreements, NOVs, interagency
agreements, or equivalent state enforcement actions.
(NOTE: For those open items, indicate what corrective action is planned and
milestones established to correct problems.)
PM.1.2. Facilities are
required to comply with all
applicable federal regulatory
requirements pertaining to
pesticides management not
contained in this checklist.
Determine if any new regulations have been issued since the finalization of this
document. If so, update the checklist to include new requirements.
Determine if the facility has activities or facilities that are regulated, but not
addressed in this checklist.
Verify that the facility is in compliance with all applicable and newly issued
regulations.
(NOTE: In addition to pesticide-specific regulations, facilities are required to
comply with other applicable regulations on subjects such as hazardous waste,
wastewater, and hazardous materials storage.)
(NOTE: U.S. EPA provides guidance and policy determinations through
Reregistration Eligibility Decisions (REDs) and Pesticide Registration (PRs)
notices. This guidance should be consulted for additional policies, procedures,
and regulatory decisions. REDs and PRs are available from:
http://www.epa.gov/pesticides/chemreg.htm)
PM.1.3. Facilities are
required to comply with state
and local regulations
concerning pesticides
management.
Verify that the facility is complying with state and local requirements.
Verify that the facility is operating according to permits issued by the state or local
agencies.
(NOTE: Issues typically regulated by state and local agencies include the
following:
- applicator certification
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
COMPLIANCE CATEGORY:
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGMENT
PRACTICE
REVIEWER CHECKS
- restricted-use pesticides
- application procedures
- suspended or canceled pesticides
- disposal methods
- emergency application of pesticides due to public health threats.)
(NOTE: In addition to pesticide-specific regulations, facilities are required to
comply with other applicable regulations on subjects such as hazardous waste,
wastewater, and hazardous materials storage.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
EXPERIMENTAL USE
PERMITS
PM.10
PM.10.1. An experimental
use permit is required in
certain situations (40 CFR
172.2 and 172.3).
Verify that any person accumulating information necessary to register a pesticide
not registered with U.S. EPA or register a pesticide for a use not previously
approved in the registration of the pesticide has an experimental use permit.
Verify that pesticides under experimental use permits are not sold or distributed
other than through participants and, if sold or distributed through participants, are
used only at an application site of a cooperator and in accordance with the terms
and conditions of the experimental use permit.
(NOTE: It may be presumed that EUPs are not required when:
-the experimental use of the pesticide is limited to:
- laboratory or greenhouse tests
- limited replicated field trials to confirm such tests
-other tests whose purpose is only to assess the pesticide's potential
efficacy, toxicity, or other properties
-the producer, applicator, or any other person conducting the test does not
expect to receive any benefit in pest control from the pesticide's use.)
(NOTE: The following types of experimental tests are presumed not to need an
EUP:
-a small-scale test involving use of a particular pesticide conducted on a
cumulative total of no more than 10 acres of land per pest, except that:
- when testing for more than one target pest occurs at the same time and
in the same locality, the 10 acre limitation encompasses all of the target
pests
- any food or feed crops involved in, or affected by, such tests (including,
but not limited to, crops subsequently grown on such land which may
reasonably be expected to contain residues of the tested pesticides) are
destroyed or consumed only by experimental animals unless an
appropriate tolerance or exemption from a tolerance has been
established under the FFDCA for residues of the pesticide
- a small-scale test involving the use of a particular pesticide conducted on a
cumulative total of no more than 1 surface acre of water per pest, except that:
- when the testing for more than one target pest occurs at the same time
and in the same locality, the 1 acre limitation encompasses all of the
target pests
- waters which are involved in or affected by such tests are not used for
irrigation purposes, drinking water supplies, or body contact
recreational activities
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
-testing is not conducted in any waters which contain or affect fish,
shellfish, plants, or animals taken for recreational or commercial
purposes and used for food or feed, unless an appropriate tolerance or
exemption from a tolerance has been established under the FFDCA for
residues of the pesticide
-animal treatment tests involving the use of a particular pesticide are
conducted only on experimental animals which are not used for food or feed,
unless an appropriate tolerance or an exemption from a tolerance has been
established for animal products and byproducts under the FFDCA for
residues of the pesticide.)
(NOTE: The examples of experimental tests that are presumed not to need a EUP
are not all-inclusive and do not preclude testing in larger areas or larger numbers
of units. Persons intending to conduct tests who are uncertain whether the testing
may be conducted without a permit may submit a request for determination to the
Registration Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg, 1200 Pennsylvania Ave, NW. Washington,
DC 20460, Telephone: (703-305-5447).)
(NOTE: No EUP is required for a substance or mixture of substances being put
through tests for the sole purpose of gathering data required for approval of such
substance or mixture under the FFDCA as:
- a "new drug"
- a "new animal drug'"
- an "animal feed" containing a "new animal drug".)
PM.10.2. Applications for
experimental use permits are
required to meet specific
parameters (40 CFR 172.4
and 172.9).
Verify that, an application or request for amendment to an existing EUP is
submitted in triplicate to the Registration Division, Office of Pesticide Programs,
Environmental Protection Agency, Washington, DC 20460, as far as possible in
advance of the intended date of shipment or use.
Verify that the application includes:
-the name and address of the applicant
-the registration number of the product, if registered
-the purpose or objectives of the proposed testing; a description in detail of
the proposed testing program including test parameters; a designation of the
pest organism(s) involved; the amount of pesticide product proposed for use;
the crops, fauna, flora, sites, modes, dosage rates, and situation of application
on or in which the pesticide is to be used; the states in which the proposed
program will be conducted; the number of acres, number of structural sites,
or number of animals by state to be treated or included in the area of
experimental use; the proposed dates or period(s) during which the testing
program is to be conducted; and the manner in which supervision of the
program will be accomplished
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
-the name, street address, telephone number, and qualifications of all
participants in the program (whether or not in the employ of the applicant)
- the name and street address of all cooperators, if available at the time an
application is submitted, or as soon thereafter as available
- a description and the specific results of any appropriate prior testing of the
product conducted by the applicant to determine toxicity and effects in or on
target organisms at the site of application; and to determine phytotoxicity and
other forms of toxicity or effects on nontarget plants, animals, and insects at
or near the site of application; and to determine adverse effects on the
environment
- the proposed method of storage and disposition of any unused experimental
use pesticide and its containers
-such other additional pertinent information as the U.S. EPA or authorized
regulatory agency may require.
(NOTE: Testing intended to support a registration must be conducted in
accordance with the Good Laboratory Practice Standards (40 CFR Part 160).)
Verify that, if the experimental use pesticide is to be used in such a manner that
any residue can reasonably be expected to result in or on food or feed, the
applicant does one of the following:
- submits evidence that a tolerance or exemption from the requirement of a
tolerance has been established for residues of the pesticide in or on such food
or feed under section 408 of the FFDCA, or a regulation promulgated under
section 409 of the FFDCA
- submits a petition proposing establishment of a tolerance or an exemption
from the requirement of a tolerance under section 408, or a regulation under
section 409, of the FFDCA
- certifies that the food or feed derived from the experimental program will be
destroyed or fed only to experimental animals for testing purposes, or
otherwise disposed of in a manner which will not endanger man or the
environment.
Verify that, for unregistered pesticide products, the following is included:
- a complete confidential statement of composition for the formulation to be
tested giving the name and percentage by weight of each ingredient, active
and inert
- chemical and physical properties of each active ingredient of the formulation
to be tested, including, but not limited to, the manufacturing or laboratory
processes and analytical methods suitable for determining the active
ingredients in the formulation
- appropriate date, if available, on the rate of decline of residues on the treated
crop or environmental site or other information for determination regarding
entry of persons into treated areas
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
- results of toxicity tests and other data relevant to the product's potential for
causing injury to the users or other persons who may be exposed, including
any available epidemiological information as to man.
Verify that a EUP is amended to add or change participants.
Verify that applications for renewal are submitted before the current permit
expires.
PM.10.3. EUP programs are
subject to surveillance and
reporting requirements (40
CFR 172.8).
Verify that the permittee supervises the test program and evaluates the results of
testing at each site of application.
Verify that the permittee immediately reports to the U.S. EPA or authorized
regulatory agency, or to any person designated by U.S. EPA or authorized
regulatory agency, any adverse effects from use of, or exposure to, the pesticide.
Verify that a final report is submitted to the Registration Division within 180 days
after the expiration of the permit, unless a request for extension of time is
approved, and the report includes:
-all data gathered during the testing program; field notes need not be
submitted but must be maintained and submitted upon request
- a description of the disposition of any pesticide containers and any unused
pesticides including amounts disposed of and the method and site of
disposition
- the method of disposition of affected food and/or feed.
(NOTE: The data gathered during the testing program may be submitted as part of
an application for registration submitted within 180 days after the expiration of the
permit, provided that the final report includes a statement that such application has
been made, and the date of such application.)
(NOTE: Testing intended to support a registration must be conducted in
accordance with the Good Laboratory Practice Standards (40 CFR Part 160).)
Verify that, in the case of any meat-producing animals or birds that receive a direct
treatment or application of any experimental use pesticide, the name and location
of the packing plant where the animals will be processed is sent to the U.S.
Department of Agriculture, Animal and Plant Health Inspection Service,
Washington, D.C. 20250, at least 10 days before the animals are to be shipped for
slaughter.
(NOTE: This requirement may be waived, on request, by the USDA. These
provisions do not exempt treated food-producing animals and their products from
compliance with other applicable inspection requirements.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
PM.10.4. Any person who
plans to conduct small-scale
testing of a type of microbial
pesticide must submit a
Notification to U.S. EPA and
obtain prior approval (40 CFR
172.45 through 172.48).
Verify that individuals who plan to conduct small-scale testing of a type of
microbial pesticide submit a Notification to U.S. EPA and obtain prior approval
for either of the following tests:
-small-scale tests that involve an intentional environmental introduction of
that microbial pesticide
- small-scale tests performed in a facility without adequate containment and
inactivation controls.
(NOTE: Instead of a Notification, individuals may submit an application for an
experimental use permit (EUP) to U.S. EPA for approval.)
(NOTE: This requirement applies to either of the following microbial pesticides:
-microbial pesticides whose pesticidal properties have been imparted or
enhanced by the introduction of genetic material that has been deliberately
modified
- nonindigenous microbial pesticides that have not been acted upon by the
USDA (i.e., either by issuing or denying a permit or determining that a
permit is unnecessary; or a permit is not pending with the USDA).
(NOTE: Microbial pesticides resulting from deletions or rearrangements within a
single genome that are brought about by the introduction of genetic material that
has been deliberately modified are exempt from the notification requirement.)
(NOTE: Testing conducted in a facility with adequate containment and
inactivation controls, as provided in 40 CFR 172.45(e), does not require a
notification (40 CFR 172.45(d)(2).)
(NOTE: Testing intended to support a registration must be conducted in
accordance with the Good Laboratory Practice Standards (40 CFR Part 160).)
Verify that the selection and use of containment and inactivation controls for a
particular microbial pesticide takes the following into account:
-factors relevant to the microbial pesticide's ability to survive in the
environment
- potential routes of release in air, solids, and liquids; in or on waste materials
and equipment; in or on people (including maintenance and custodial
personnel); and in or on other organisms such as insects and rodents
- procedures for transfer of materials between facilities
- plans for routine or emergency clean-up and test termination.
(NOTE: U.S. EPA will presume that compliance with the containment provisions
of the National Institutes of Health (NIH) "Guidelines for Research Involving
Recombinant DNA Molecules" (51 FR 16958, May 7, 1986) constitutes selection
and use of adequate containment and inactivation controls.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
Verify that the selection of containment and inactivation controls is approved by
an authorized official of the organization that is conducting the test prior to
commencement of the test.
Verify that records are developed and maintained describing the selection and use
of the containment and inactivation controls, including contingency plans for
emergency clean-up and test termination, that will be used during the test.
Verify that these records are available for inspection at the test facility.
Verify that, records are submitted to U.S. EPA at U.S. EPA's request and within
the time frame specified in U.S. EPA's request.
Verify that a notification is submitted for approval at least 90 days prior to the
initiation of the proposed test.
(NOTE: See 40 CFR 172.46 and 172.48 for details on the format and content of
the Notification.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
PESTICIDE
REGISTRATION
PM.20
PM.20.1. No person can
distribute or sell any pesticide
product that is not registered
under FIFIRA (40 CFR
152.15, 152.30, and 155.25).
Verify that no person distributes or sells any pesticide product that is not
registered under FIFRA.
(NOTE: A pesticide is any substance (or mixture of substances) intended for a
pesticidal purpose, i.e., use for the purpose of preventing, destroying, repelling, or
mitigating any pest or use as a plant regulator, defoliant, or desiccant. A substance
is considered to be intended for a pesticidal purpose, and thus to be a pesticide
requiring registration, if:
- the person who distributes or sells the substance claims, states, or implies (by
labeling or otherwise) one of the following:
- that the substance (either by itself or in combination with any other
substance) can or should be used as a pesticide
- that the substance consists of or contains an active ingredient and that it
can be used to manufacture a pesticide
- the substance consists of or contains one or more active ingredients and has
no significant commercially valuable use as distributed or sold other than:
- use for pesticidal purpose (by itself or in combination with any other
substance)
- use for manufacture of a pesticide
- the person who distributes or sells the substance has actual or constructive
knowledge that the substance will be used, or is intended to be used, for a
pesticidal purpose.)
(NOTE: See Appendix A for exempted pesticides.)
(NOTE: An unregistered pesticide, or a pesticide whose registration has been
canceled or suspended, may be distributed or sold, or otherwise transferred as
follows:
-an unregistered pesticide may be transferred between registered
establishments operated by the same producer when labeled in accordance
with 40 CFR Part 156 (see checklist item PM.30.1)
-an unregistered pesticide may be transferred between registered
establishments not operated by the same producer if:
- the transfer is solely for the purpose of further formulation, packaging,
or labeling into a product that is registered
- each active ingredient in the pesticide, at the time of transfer, is present
as a result of incorporation into the pesticide of either a registered
product or a pesticide that is produced by the registrant of the final
product; and
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
- the product as transferred is labeled in accordance with 40 CFR Part
156 (see checklist item PM.30.1)
- an unregistered pesticide may be distributed or sold in accordance with the
terms of an experimental use permit issued under FIFRA sec. 5, if the
product is labeled in accordance with 40 CFR 172.6 (see checklist item
PM.30.2)
- an unregistered pesticide may be distributed or sold in accordance with the
provisions pertaining to use of a pesticide for which an experimental use
permit is not required, provided the product is labeled in accordance with 40
CFR Part 156 (see checklist item PM.30.1)
- an unregistered pesticide may be transferred within the United States solely
for export if it meets the following conditions:
- the product is prepared and packaged according to the specifications of
the foreign purchaser
- the product is labeled in accordance with 40 CFR Part 156 (see
checklist item PM.30.1)
- an unregistered pesticide may be distributed or sold in accordance with the
terms of an emergency exemption under FIFRA sec. 18, if the product is
labeled in accordance with 40 CFR Part 156 (see checklist item PM.30.1)
- an unregistered, suspended, or canceled pesticide may be transferred solely
for disposal in accordance with FIFRA sec. 19, or an applicable order from
the U.S. EPA or authorized regulatory agency, if labeled in accordance with
40 CFR Part 156 (see checklist item PM.30.1)
- a canceled or suspended pesticide may be distributed or sold to the extent
and in the manner specified in an order issued by the U.S. EPA or authorized
regulatory agency concerning existing stocks of the pesticide.)
PM.20.2. Registration of a
pesticide is required to be
done according to certain
specifications (40 CFR
152.30, 152.42 and 152.43).
Verify that any person seeking to obtain a registration for a new pesticide product
submits an application for registration.
(NOTE: See 40 CFR 152.50 for the contents of the application. See 40 CFR
155.27 through 155.34 for details on the U.S. EPAs responsibilities for reviewing
the submitted data, requesting meetings, creating a public docket, and issuing a
Notice of Availability.)
(NOTE: U.S. EPA provides guidance and policy determinations through
reregistration Eligibility Decisions (REDs) and Pesticide Registration (PRs)
notices. This guidance should be consulted for additional policies, procedures,
and regulatory decisions. REDs and PRs are available from:
http://www.epa.gov/pesticides/chemreg.htm.)
Verify that the application for new registration was approved by the U.S. EPA
before the product was distributed or sold.
(NOTE: An unregistered pesticide, or a pesticide whose registration has been
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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COMPLIANCE CATEGORY
PESTICIDES MANAGEMENT
REGULATORY
REQUIREMENT OR
MANAGEMENT
PRACTICE
REVIEWER CHECKS
canceled or suspended, may be distributed or sold, or otherwise transferred as
follows:
-an unregistered pesticide may be transferred between registered
establishments operated by the same producer when labeled in accordance
with 40 CFR Part 156 (see checklist item PM.30.1)
-an unregistered pesticide may be transferred between registered
establishments not operated by the same producer if:
- the transfer is solely for the purpose of further formulation, packaging,
or labeling into a product that is registered
- each active ingredient in the pesticide, at the time of transfer, is present
as a result of incorporation into the pesticide of either a registered
product or a pesticide that is produced by the registrant of the final
product
- the product as transferred is labeled in accordance with 40 CFR Part
156 (see checklist item PM.30.1)
- an unregistered pesticide may be distributed or sold in accordance with the
terms of an experimental use permit issued under FIFRA sec. 5, if the
product is labeled in accordance with 40 CFR 172.6 (see checklist item
PM.30.2)
- an unregistered pesticide may be distributed or sold in accordance with the
provisions pertaining to use of a pesticide for which an experimental use
permit is not required, provided the product is labeled in accordance with 40
CFR Part 156 (see checklist item PM.30.1)
- an unregistered pesticide may be transferred within the United States solely
for export if it meets the following conditions:
- the product is prepared and packaged according to the specifications of
the foreign purchaser
- the product is labeled in accordance with 40 CFR Part 156 (see
checklist item PM.30.1)
- an unregistered pesticide may be distributed or sold in accordance with the
terms of an emergency exemption under FIFRA sec. 18, if the product is
labeled in accordance with 40 CFR Part 156 (see checklist item PM.30.1)
- an unregistered, suspended, or canceled pesticide may be transferred solely
for disposal in accordance with FIFRA sec. 19, or an applicable order from
the U.S. EPA or authorized regulatory agency, if labeled in accordance with
40 CFR Part 156 (see checklist item PM.30.1)
- a canceled or suspended pesticide may be distributed or sold to the extent
and in the manner specified in an order issued by the U.S. EPA or authorized
regulatory agency concerning existing stocks of the pesticide.)
(NOTE: A product proposed for registration must have a single, defined
composition, except that U.S. EPA may approve a basic formulation and one or
more alternate formulations for a single product.)
Verify that alternate formulations meet the following criteria:
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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-the alternate formulation has the same certified limits for each active
ingredient as the basic formulation
-if the alternate formulation contains an inert ingredient or impurity of
lexicological significance, the formulation has the same upper certified limit
for that substance as the basic formulation
- the label text of the alternate formulation product is identical to that of the
basic formulation
-the analytical method required under 40 CFR 158.180 is suitable for use on
both the basic formulation and the alternate formulation.
(NOTE: The Agency may determine that an alternate formulation must be
separately registered. If U.S. EPA makes this determination, the Agency will
notify the applicant of its determination and its reasons. Thereafter the application
for an alternate formulation will be treated as an application for new registration,
and the alternate formulation will be assigned a new registration number.)
PM.20.3. Any modification
in the composition, labeling,
or packaging of a registered
product must be submitted
with an application for
amended registration (40 CFR
152.44 and 152.46).
Verify that any modification in the composition, labeling, or packaging of a
registered product is submitted with an application for amended registration.
Verify that the applicant submits the information required by 40 CFR 152.50, as
applicable to the change requested.
(NOTE: If an application for amended registration is required, the application
must be approved by the U.S. EPA before the product, as modified, may legally be
distributed or sold.)
(NOTE: In its discretion, the U.S. EPA may:
-waive the requirement for submission of an application for amended
registration
- require that the applicant certify to the Agency that he has complied with an
Agency directive rather than submit an application for amended registration
-permit an applicant to consolidate an amendment affecting a number of
products into a single application
-permit an applicant to modify a registration by notification or non-
notification.)
(NOTE: U.S. EPA may determine that certain minor modifications to registration
having no potential to cause unreasonable adverse effects to the environment may
be accomplished by notification to the Agency, without requiring that the
registrant obtain Agency approval. If this is the case, U.S. EPA will issue
procedures following an opportunity for public comment describing the types of
modifications permitted by notification and any conditions and procedures for
submitting notifications.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.20.4. Registrants are
required to provide certain
information to the U.S. EPA
(40 CFR 152.122 and
152.125).
Verify that the registrant keeps the Agency informed of his current name and
address of record.
Verify that the registrant responds within 30 days of the Agency issuing a NOI to
cancel all products in the Federal Register.
(NOTE: If no response is received, the cancellations will become effective at the
end of 30 days without further notice to the registrant. The Agency may make
provision for the sale and distribution of existing stocks of such products after the
effective date of cancellation.)
Verify that the registrant also notifies the Agency if he changes his authorized
agent.
Verify that, if at any time the registrant receives or becomes aware of any factual
information regarding unreasonable adverse effects of the pesticide on the
environment that has not previously been submitted to the Agency, he provides
such information to the Agency, clearly identified as FIFRA 6(a)(2) data.
PM.20.5. A registrant may
distribute or sell his registered
product under another
person's name and address if
specific parameters are met
(40 CFR 152.132).
Verify that the registrant has submitted to the Agency for each distributor product
a statement signed by both the registrant and the distributor listing the names and
addresses of the registrant and distributor, the distributor's company number, the
additional brand name(s) to be used, and the registration number of the product.
Verify that the distributor product is produced, packaged, and labeled in a
registered establishment operated or under contract with the same producer who
produces, packages, and labels the registered product.
Verify that the distributor product is not repackaged.
Verify that the label of the distributed product is the same as that as the registered
product, except that:
-the product name of the distributed product may be different (but not
misleading)
- the name and address of the distributor may appear instead of that of the
registrant
- the registration number of the product is followed by a dash and includes the
distributor's company number
- the establishment number must be the number of the final establishment at
which it was produced
- specific claims may be deleted.
(NOTE: Voluntary cancellation of a product applies to the registered product and
all distributor products distributed or sold under that registration number.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.20.6. Transfer of
registration must meet specific
parameters (40 CFR 152.135).
Verify that, if the registrant transfers the registration of a product to another
person, and the registered product is distributed and sold without the requirement
of a new application for registration by that other person, the following documents
are submitted to the Agency and Agency approval has been received:
- a document signed by the authorized representative of the registrant (the
transferor) and of the person to whom the registration is transferred (the
transferee) that contains the following information:
-the name, address and state of incorporation (if any) of the transferor
-the name, address and state of incorporation of the transferee
-the name(s) and U.S. EPA registration number(s) of the product(s)
being transferred
- a statement that the transferor transfers irrevocably to the transferee all
right, title, and interest in the U.S. EPA registrations) listed in the
document
- a statement that the transferred registrations) shall not serve as
collateral or otherwise secure any loan or other payment arrangement or
executory promise, and that the registration(s) shall not revert to the
transferor unless a new transfer agreement is submitted to and approved
by the Agency
- a description of the general nature of the underlying transaction, e.g.,
merger, spinoff, bankruptcy transfer (no financial information need be
disclosed)
- a statement that the transferor and transferee understand that any false
statement may be punishable under 18 USC 1001
- an acknowledgment by the transferee that his rights and duties
concerning the registration will be deemed by U.S. EPA to be the same
as those of the transferor at the time the transfer is approved
- a notarized statement affirming that:
- the person signing the transfer agreement is authorized by the registrant
to bind the transferor
- no court order prohibits the transfer, and that any required court
approvals have been obtained
- the transfer is authorized under all relevant federal, state and local laws
and all relevant corporate charters, bylaws, partnerships, or other
agreements.
(NOTE: The transfer will be effective on the date of Agency approval. Thereafter
the transferee will be regarded as the registrant for all purposes under FIFRA.)
(NOTE: Rights to exclusive use of data or compensation under FIFRA sec.
3(c)(l)(D) are separate from the registration itself and may be retained by the
transferor, or may be transferred independently. If the registrant as the original
data submitter wishes to transfer data rights at the same time as he transfers the
registration, he may submit a single transfer document containing the information
required by this section for both the registration and the data.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.30
PESTICIDE LABELING
PM.30.1. Pesticide labels are
required to contain specific
information (40 CFR
156.10(a)(l) through
Verify that every pesticide product has a label which shows clearly and
prominently the following:
- the name, brand, or trademark
-the name and address of the producer, registrant, or person for whom
produced
- the net contents
- the product registration number
- the producing establishment number
- an ingredient statement
- warning or precautionary statements
- the directions for use
- the use classification.
Verify that all words, statements, graphic representations, designs or other
information required on the labeling are clearly legible to a person with normal
vision, and are placed with such conspicuousness (as compared with other words,
statements, designs, or graphic matter on the labeling) and expressed in such terms
as to render it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
Verify that all required label text is:
- set in 6-point or larger type
- appears on a clear contrasting background
- is not be obscured or crowded.
Verify that all required label or labeling text appears in the English language.
(NOTE: The Agency may require or the applicant may propose additional text in
other languages as is considered necessary to protect the public. When additional
text in another language is necessary, all labeling requirements will be applied
equally to both the English and other-language versions of the labeling.)
Verify that the label appears on or is securely attached to the immediate container
of the pesticide product.
(NOTE: For purposes of this requirement, and the misbranding provisions of the
Act, "securely attached" means that a label can reasonably be expected to remain
affixed during the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container through which the
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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label cannot be clearly read, the label must also be securely attached to such
outside wrapper or container, if it is a part of the package as customarily
distributed or sold.)
Verify that when any registered pesticide product is transported in a tank car, tank
truck or other mobile or portable bulk container, a copy of the accepted label is
attached to the shipping papers, and left with the consignee at the time of delivery.
Verify that when pesticide products are stored in bulk containers, whether mobile
or stationary, which remain in the custody of the user, a copy of the label of
labeling, including all appropriate directions for use, is securely attached to the
container in the immediate vicinity of the discharge control valve.
PM.30.2. All pesticides
shipped or used under an
experimental use permit are
required to be labeled
according to certain
parameters (40 CFR 172.6).
Verify that all pesticides shipped or used under an experimental use permit are
labeled with directions and conditions for use, including the following:
-the prominent statement, "For Experimental Use Only"
- the Experimental Use Permit number
-the statement, "Not for sale to any person other than a participant or
cooperator of the U.S. EPA-approved Experimental Use Program"
- the name, brand, or trademark
-the name and address of the permittee, producer, or registrant
- the net contents
- an ingredient statement
- warning or caution statements
- any appropriate limitations on entry of persons into treated areas
-the establishment registration number, except in those cases where
application of the pesticide is made solely by the producer
-the directions for use, except that the U.S. EPA or authorized regulatory
agency may approve the use of the experimental program as labeling
provided that such program is to be distributed with the product.
(NOTE: In the case of a registered pesticide, the U.S. EPA or authorized
regulatory agency may, at its discretion, permit a pesticide to be used under an
experimental use permit with supplemental labeling as approved by the U.S. EPA
or authorized regulatory agency.)
PM.30.3. Certain
requirements must be met for
pesticide export label and
labeling requirements (40
CFR 168.65)
Verify that every exported pesticide, device, and active ingredient used in
producing a pesticide bears a label or labeling that meets the requirements of
FIFRA sec. 17(a)(l), 7 USC sec. 136o(a)(l).
(NOTE: This requirement applies regardless of whether the export is for
commercial or research use.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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(NOTE: This requirement applies to unregistered pesticides regardless of whether
the exporter must submit a purchaser acknowledgment statement under FIFRA
sec. 17(a)(2), 7 USC sec. 136o(a)(2) as described at 40 CFR 168.75.)
Verify that the label shows clearly and prominently the following:
- the name, brand, or trademark
- the name and address of the producer, registrant, or person for whom
produced
- the net contents (expressed in English or metric terms)
- the producing establishment number
- the ingredient statement in English and the appropriate foreign language(s)
- warning or precautionary statement in English and the appropriate foreign
language(s)
- the use classification in English and the appropriate foreign language(s)
- either the information included on the EPA approved label if the product is
registered for use in the United States or the phrase "Not Registered for Use
in the United States of America" in English and the appropriate foreign
language(s)
(NOTE: To determine if a pesticide is considered registered for purposes under
FIFRA sec. 17(a)(l), 7 USC sec. 136o(a)(l), refer to 40 ™™
CFR
(NOTE: Acceptable foreign languages must include either the language used in
official government business or the predominantly spoken or written language of
the country of import. 40 CFR 168.65(b)(4)(D)(ii))
(NOTE: Supplemental labeling is permitted if it satisfies 40 CFR 168.65(c).)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.40
RESTRICTED USE
PESTICIDES
PM.40.1. Restricted use
pesticides must be managed
according to specific
parameters (40 CFR 152.166
through 152.168).
Verify that a product whose labeling bears directions for end use and that has been
classified for restricted use, is labeled in accordance with the requirements of 40
CFR 156.10 (see checklist item PM.30.1) or other Agency instructions.
(NOTE: The Agency will permit the use of stickers or supplemental labeling as an
interim alternative to the use of an approved amended label.)
(NOTE: A product whose labeling does not bear directions for end use (a product
that is intended and labeled solely for further formulation into other pesticide
products) does not have to meet labeling requirements.)
Verify that no product with a use classified for restricted use is distributed or sold
by the registrant or producer after the 120th day after the effective date of the
classification unless the product:
-bears an approved amended label which contains the terms of restricted use
imposed by the Agency and otherwise complies with 40 CFR Part 156 (see
checklist item PM.30.1)
-bears a sticker containing the product name, U.S. EPA registration number,
and any terms of restricted use imposed by the Agency
-is accompanied by supplemental labeling bearing the product name, U.S.
EPA registration number, and any terms of restricted use imposed by the
Agency.
Verify that, if the registrant chooses to delete the restricted uses from his product
label, that product is not distributed or sold after the 180th day after the effective
date of classification unless the product bears amended labeling with the restricted
uses deleted.
Verify that, after the 270th day after the effective date of classification, no
registrant or producer distributes or sells a product that does not bear the approved
amended label.
Verify that no product with a use classified for restricted use by a regulation is
distributed or sold by a retailer or other person after the 270th day after the
effective date of the final rule unless the product bears a compliant label or
labeling.
(NOTE: See Appendix B for the current U.S. EPA restricted use pesticide list.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.40.2. Advertising of
restricted use pesticides must
meet specific requirements
(40CFR152.168).
Verify that any product classified for restricted use is not advertised unless the
advertisement contains a statement of its restricted use classification.
(NOTE: This requirement applies to all advertisements of the product, including,
but not limited, to:
-brochures, pamphlets, circulars and similar material offered to purchasers at
the point of sale or by direct mail
-newspapers, magazines, newsletters and other material in circulation or
available to the public
-broadcast media such as radio and television
- telephone advertising
-billboards and posters.)
(NOTE: The requirement may be satisfied for printed material by inclusion of the
statement "Restricted Use Pesticide," or the terms of restriction, prominently in
the advertisement. The requirement may be satisfied with respect to broadcast or
telephone advertising by inclusion in the broadcast of the spoken words
"Restricted use pesticide," or a statement of the terms of restriction.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.50
PESTICIDE
PRODUCTION,
DISTRIBUTION, AND
PACKAGING
PM.50.1. Certain
establishments producing
pesticides and active
ingredients are required to be
registered (40 CFR 167.20).
Verify that any establishment where a pesticidal product is produced, except those
which are custom blenders only, is registered with the Agency.
(NOTE: If custom blending occurs at an establishment where other pesticide
production takes place, the establishment must be registered.)
Verify that establishments where a substance is produced which is intended to be
used as an active ingredient of a pesticide, or the producer has actual or
constructive knowledge that the substance will be used by any person as an active
ingredient of a pesticide are registered.
Verify that any domestic establishment producing a pesticidal product for export,
or any unregistered pesticide, or any foreign establishment producing a pesticidal
product for import into the United States is registered.
Verify that any establishment, either foreign or domestic, which produces a
pesticidal product for use under an Experimental Use Permit, FIFRA section 18
Emergency Exemption or section 24(c), Special Local Needs registration, is
registered.
Verify that applicants for establishment registration submit the following
information:
- name and address of the company
-the type of ownership (individual, partnership, cooperative association,
corporation, or any organized group of persons whether incorporated or not)
- the name and address of each producing establishment for which registration
is sought.
Verify that an application for establishment registration is submitted, and an
establishment registration number is assigned by the Agency, before any
production occurs at an establishment.
(NOTE: The Agency will return incomplete or inaccurately completed
applications to the applicant. If the application is complete and accurate, the
Agency will register the establishment and assign a registration number to the
establishment. The establishment registration number will be entered on the
application, and a copy of the application will be returned to the applicant.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Verify that, if at any time after the first report there is a change in the required
information, that new information is reported to U.S. EPA, in writing on letterhead
stationery or on forms supplied by the Agency, within 30 days after such change
occurs.
(NOTE: Establishment registration will remain effective provided pesticide
reports are submitted annually. Failure to submit a report may result in termination
of establishment registration, civil and/or criminal penalty assessments.)
PM.50.2. Pesticide producers
are required to meet reporting
requirements (40 CFR
167.85).
Verify that each producer operating an establishment submits an annual reports on
or before March 1 of each year, even if the producer has produced no pesticidal
product for that reporting year.
(NOTE: This applies to establishments producing pesticides, active ingredients,
or devices. It does not apply to those who are solely custom blenders.)
Verify that the report includes the following information:
-name and address of the establishment
- amount of each pesticidal product:
- produced during the past year
- sold or distributed during the past year
- estimated to be produced during the current year.
(NOTE: The report includes only those pesticidal products actually produced at
the reporting establishment. Reports submitted by foreign-producing
establishments cover only those pesticidal products exported to the United States.)
Verify that the reports are submitted on forms supplied by the Agency.
Verify that an initial report is submitted no later than 30 days after the first
registration of each establishment the producer operates.
PM.50.3. All producers of
pesticides, devices, or active
ingredients used in producing
pesticides subject to FIFRA
are required to maintain
specific records (40 CFR
169.2).
(NOTE: This requirement applies to all producers of pesticides, devices, or active
ingredients used in producing pesticides subject FIFRA, including pesticides
produced pursuant to an experimental use permit, and pesticides, devices, and
pesticide active ingredients produced for export.)
Verify that records showing the product name, U.S. EPA Registration Number,
Experimental Permit Number if the pesticide is produced under an Experimental
Use Permit, and the amounts per batch, and batch identification (numbers, letters,
etc.) of all pesticides produced are maintained for 2 yr.
(NOTE: In cases where the product is an active ingredient used in producing a
pesticide or where the product is a pesticide which is not registered, is not the
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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subject of an application for registration, or is not produced under an Experimental
Use Permit, the records shall also show the complete formula.)
Verify that the batch identification appears on all production control records.
Verify that records showing the brand names and quantities of devices produced
are retained for 2 yr.
Verify that records showing the following information regarding receipt, by the
producer, of all pesticides, devices, and active ingredients used in producing
pesticides, are retained for 2 yr:
-brand name of the pesticide or device, or common or chemical name of the
pesticide active ingredient
- name and address of shipper
- name of delivering carrier
- date received
- quantities received.
(NOTE: These records are not intended to cover receipt of pesticides used for in-
plant maintenance, extermination, or sanitation programs, etc. Shipping and
receiving documents such as invoices, freight bills, receiving tickets, etc., which
provide the required information will be considered satisfactory.)
Verify that records showing the following information regarding the shipment of
all pesticides, devices, and active ingredients used in producing pesticides are
retained for 2 yr:
-brand name of pesticide or device, or the common or chemical name of the
pesticide active ingredient
- name and address of consignee
- where the pesticide is produced pursuant to an EUP, a special exemption, or
a special local need, the information required under these parameters
regarding the distribution of such pesticides
- name of originating carrier
- date shipped or delivered for shipment
- quantities shipped or delivered for shipment.
(NOTE: Records are required regardless of whether any shipment or receipt of
shipment is between plants owned or otherwise controlled by the same person.
Shipping and receiving documents such as invoices, freight bills, receiving tickets,
etc., which provide the required information will be considered satisfactory.
Verify that inventory records are kept with respect to the types and amounts of
pesticides or pesticide active ingredients, or quantities of devices in stock which
have been produced.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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(NOTE: Inventory records may be disposed of when a more current inventory
record is prepared.)
Verify that copies of all domestic advertising of the restricted uses of any pesticide
registered for restricted use, including any radio or television scripts, for all such
pesticides are retained for 2 yr.
Verify that copies of all guarantees given pursuant to section 12(a)(2)(C) of
FIFRA are retained for 1 yr after expiration of the guarantee.
Verify that, the following records are retained for 2 yr after expiration of the
contract for all pesticides, devices, and active ingredients used in producing
pesticides intended solely for export to any foreign country:
- copies of the specification or directions of the foreign purchaser for the
production of such pesticides, devices, or pesticide active ingredients
-copies of labels or labeling required to comply with section 17(a)(l) of
FIFRA
-for any pesticide other than a pesticide registered under section 3 or sold
under section 6(a)(l) of FIFRA, copies of a statement signed by the foreign
purchaser of the pesticide acknowledging that the purchaser understands that
such pesticide is not registered for use in the United States and cannot be
sold in the United States under FIFRA.
Verify that records on the method of disposal (burial, incineration, etc.), date or
dates of disposal, location of the disposal sites, and the types and amounts of
pesticides or pesticide active ingredients disposed of by the producer or his
contractor are retained.
(NOTE: With regard to the disposal of containers accumulated during production,
the Agency will consider satisfactory a statement, attested to by a responsible firm
official, describing in general terms the method and location of disposal, e.g., all
containers are taken periodically to a certain site.)
Verify that records of deviations from normal disposal practices are maintained.
Verify that records on the disposal of pesticides or pesticide active ingredients
and/or containers specified pursuant to section 19 of the FIFRA and associated
promulgated regulations are maintained.
(NOTE: The disposal record requirements apply to those products bearing label
instructions for disposal and to any other products specified under any regulations
promulgated pursuant to section 19 of FIFRA.)
Verify that disposal records are retained for 20 yr or are forwarded after 3 yr to the
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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U.S. EPA Regional Administrator for maintenance.
(NOTE: Whenever any producer of pesticides or pesticide active ingredients is
complying with a rule promulgated under RCRA for the handling or disposal of
hazardous wastes, such producers are no longer required to maintain disposal
records in accordance with these requirements.)
Verify that records of any tests conducted on human beings, whether performed by
the producer himself, or authorized and/or paid for by the producer, are kept and
include:
- the names and addresses of subjects tested
-dates of tests
-types of tests
- written consent of subjects to test
- all information and instructions given to the subjects regarding the nature and
purpose of the tests and of any physical and mental health consequences
which were reasonably foreseen therefrom, and any adverse effects of the test
on the subjects, including any such effects coming to the attention of the
producer after completion of the tests.
Verify that the records on tests conducted on human beings are retained for 20 yr
or are forwarded after 3 yr to the U.S. EPA Regional Administrator for
maintenance.
Verify that records containing research data relating to registered pesticides,
including all test reports submitted to the Agency in support of registration or in
support of a tolerance petition, all underlying raw data, and interpretations and
evaluations thereof, whether in the possession of the producer or in the possession
of the independent testing facility or laboratory (if any) which performed such
tests on behalf of the producer, are retained as long as the registration is valid and
the producer is in business.
PM.50.4. Registrants are
required to meet specific
parameters concerning
distribution of pesticides (40
CFR 152.130 and 152.132)
Verify that a registrant only distributes or sells registered products with the
composition, packaging and labeling currently approved by the Agency.
Verify that if a registrant distributes or sells products under labeling bearing any
subset of the approved directions for use, when limiting the uses listed on the
label, no changes are necessary in precautionary statements, use classification, or
packaging of the product.
(NOTE: Normally, if the product labeling is amended on the initiative of the
registrant, by submission of an application for amended registration, the registrant
may distribute or sell under the previously approved labeling for a period of 18 mo
after approval of the revision, unless an order subsequently issued provides
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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otherwise. However, if the product labeling is required to be revised as a result of
the issuance of a Registration Standard, a Label Improvement Program notice, or a
notice concluding a special review process applies to the registrant's product, the
time frames established by the Agency takes precedence.)
(NOTE: Pesticides that are unregistered in the United States, but are produced
only for export must comply with FIFRA Sec. 17, 7 USC Sec. 136o. Exporters
shipping unregistered products must meet specific alternative requirements. 40
CFR 168.75)
Verify that if the registrant distributes or sells his registered product under another
person's name and address instead of (or in addition to) his own, the Agency has
been notified and all the following conditions met:
-the registrant has submitted to the Agency for each distributor product a
statement signed by both the registrant and the distributor listing the names
and addresses of the registrant and the distributor, the distributor's company
number, the additional brand name(s) to be used, and the registration number
of the registered product
-the distributor product is produced, packaged and labeled in a registered
establishment operated by the same producer (or under contract) who
produces, packages, and labels the registered product
- the distributor product is not repackaged (remains in the producer's unopened
container)
-the label of the distributor product is the same as that of the registered
product, except that:
- the product name of the distributor product may be different (but may
not be misleading)
-the name and address of the distributor may appear instead of that of the
registrant
- the registration number of the registered product is followed by a dash,
followed by the distributor's company number (obtainable from the
Agency upon request)
- the establishment number is that of the final establishment at which the
product was produced
- specific claims may be deleted, provided that no other changes are
necessary
-the registrant ensures that distributors under his canceled registration are
notified and comply with the terms of the cancellation.
PM.50.5. Pesticide
packaging must meet specific
criteria (40 CFR 157.22,
157.24, 157.27).
Verify that a pesticide product is distributed and sold in child-resistant packaging
if it meets both of the following criteria:
-based upon testing with an appropriate test species, the product meets any of
the following toxicity criteria:
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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-the pesticide has an acute oral LD50 of 1.5 g/kg or less
- the pesticide has an acute dermal LD50 of 2000 mg/kg or less
- the pesticide has an acute inhalation LC50 of 2 mg/L or less
- the pesticide is corrosive to the eye (causes irreversible destruction of
ocular tissue) or causes corneal involvement or irritation persisting for
21 days or more
- the pesticide is corrosive to the skin (causes tissue destruction into the
dermis and/or scarring) or causes severe skin irritation (severe erythema
or edema) at 72 h
- the pesticide or device has such characteristics that, based upon human
lexicological data, use history, accident data or such other evidence as
is available, the Agency determines there is serious hazard of accidental
injury or illness which child-resistant packaging could reduce
-the product's labeling either directly recommends residential use or
reasonably can be interpreted to permit residential use.
Verify that pesticide products distributed or sold as an aggregate of one or more
unit packages and meeting the above listed criteria are distributed or sold in child-
resistant packaging either for each unit package, or for the outer retail container
which contains the unit packages.
(NOTE: Child-resistant packaging is not required for both the outer package and
the unit packages unless the Agency determines, on a case-by-case basis, that it is
necessary for risk reduction.)
(NOTE: The following classes of products are not required to have child-resistant
packaging:
-a product restricted to use by or under the supervision of a certified
applicator, but the Agency may require the use of child-resistant packaging
for a product classified for restricted use by or under the direct supervision of
a certified applicator if the Agency determines that the product poses a risk
of serious accidental injury or illness which child-resistant packaging could
reduce.
-products distributed and sold in the following sizes (unless otherwise
required by the Agency):
- if the product is a solid product, regardless of pesticide type, a size of
50 Ib or greater
- if the product is a liquid product intended for use in swimming pools, a
size greater than 7.5 gal by volume;
- if the product is a liquid product intended for any other pesticide use, a
size of 5 gal or greater by volume
-if the product is packaged as an aerosol (measured by weight),
regardless of pesticide type, a weight of 2 Ib or greater.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.50.6. Child-resistant
packaging must meet specific
standards (40 CFR 157.32 and
157.34).
Verify that child-resistant packaging meets the effectiveness specifications in 16
CFR 1700.15(b) when in actual use as a pesticide container and for the reasonably
expected lifetime of the package.
(NOTE: This requirement may be satisfied by appropriate scientific evaluation of
the compatibility of the substance with the child-resistant packaging to determine
that the chemical and physical characteristics of the pesticide will not compromise
or interfere with the proper functioning of the child-resistant packaging, and that
the packaging will not be detrimental to the integrity of the product during storage
and use.)
(NOTE: The standard for durability must take into account the number of times
the package is customarily opened and closed. This requirement may be satisfied
by appropriate technical evaluation based on physical wear and stress factors of
packaging, the force required for activation, and other relevant factors.)
Verify that the registrant of a pesticide product required to be in child-resistant
packaging has certified to the Agency that the package meets the standards of 40
CFR 157.32.
Verify that packaging certification is submitted with each application for new
registration, if applicable.
Verify that, if the Agency has determined that a currently registered product is
required to be packaged in child-resistant packaging, a certification is submitted
within 6 mo after the Agency finally notifies the registrant of the requirement.
Verify that the certification contains the following information:
-the name and U.S. EPA registration number of the product to which the
certification applies
- the registrant's name and address
- the date
-the name, title and signature of the company official making the certification
- a statement that the packaging that is being used for the product will meet the
standards of 40 CFR 157.32 (NOTE: The statement, "I certify that the
packaging that will be used for this product meets the standards of 40 CFR
157.32," will suffice for this purpose.)
PM.50.7. Specific records
are required to be kept by the
registrant for pesticide
products which are required to
be in child-resistant packaging
(40 CFR 157.36).
Verify that the following records are maintained by the registrant:
- a description of the package, including a description of:
- the container and its dimensions and composition
-the closure or child-resistant mechanism, including the name of its
manufacturer and the manufacturer's designation for the closure or the
physical working of the child-resistant packaging mechanism.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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-a copy of the certification statement required by 40 CFR 157.34 (see
checklist item PM.50.6)
- one of the following types of records verifying that each package for the
product is child-resistant:
-test data on the package based on the Consumer Product Safety
Commission protocol in 16 CFR 1700.20
-test data, not conforming to the protocol in 16 CFR 1700.20, or a set of
measurements on the package, together with an explanation as to why
such data or measurements demonstrate that the package is child-
resistant
-test data, whether or not conforming to the protocol in 16 CFR 1700.20,
on a different package, together with an explanation of why such data
demonstrate that the package being used is child-resistant
- written evidence, in the form of one of the following, that verifies that
testing on the package has been conducted according to the protocol in
16 CFR 1700.20:
- a letter or literature from the packaging supplier
- a letter from the facility that conducted the testing
- a specification in the contract between the registrant or applicant
and the packaging supplier;
-when the container and closure are purchased separately by the
registrant:
- information showing that the closure is child-resistant
- a written explanation of why the container is child-resistant
- information showing that the closure and container are compatible
with each other, and a written explanation of why the resulting
package is child-resistant
-records verifying that the package meets the compatibility and durability
standards.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.60
PESTICIDE
APPLICATORS
PM.60.1. Commercial
applicators of restricted-use
pesticides are required to be
certified (40 CFR 171.4).
Verify that commercial applicators of restricted-use pesticides have passed a
written exam, and, as appropriate, performance testing.
Verify that they are certified for both general use and each category (see
definitions) or subcategory, if any, in which they are working.
(NOTE: See Appendix C and Appendix D of this document for the general
standards and category specific standards.)
(NOTE: These standards do not apply to the following persons:
-persons conducting laboratory type research involving restricted use
pesticides
- Doctors of Medicine and Doctors of Veterinary Medicine applying pesticides
as drugs or medication during the course of their normal practice.)
PM.60.2. Private applicators
of restricted-use pesticides are
required to be certified (40
CFR 171.5).
Verify that private applicators of restricted use pesticides are certified.
Verify that a private applicator shows that he possesses a practical knowledge of
the pest problems and pest control practices associated with his agricultural
operations; proper storage, use, handling and disposal of the pesticides and
containers; and his related legal responsibility.
Verify that the practical knowledge includes the ability to:
- recognize common pests to be controlled and damage caused by them
-read and understand the label and labeling information-including the
common name of pesticides he applied; pest(s) to be controlled, timing and
methods of application; safety precautions; any pre-harvest or re-entry
restrictions; and any specific disposal procedures
-apply pesticides in accordance with label instructions and warnings,
including the ability to prepare the proper concentration of pesticide to be
used under particular circumstances taking into account such factors as area
to be covered, speed at which application equipment will be driven, and the
quantity dispersed in a given period of operation
-recognize local environmental situations that must be considered during
application to avoid contamination
-recognize poisoning symptoms and procedures to follow in case of a
pesticide accident.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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(NOTE: Competence of each private applicator shall be verified by the
responsible state agency through the administration of a private applicator
certification system which ensures that the private applicator is competent.
PM.60.3. Supervision of
noncertified applicators is
required to be executed
according to specific
parameters (40 CFR 171.6).
Verify that, when necessary, noncertified applicators are supervised by certified
private or commercial applicators.
(NOTE: The availability of the certified applicator is directly related to the hazard
of the situation. In many situations, where the certified applicator is not required to
be physically present, "direct supervision" shall include verifiable instruction to
the competent person, as follows:
- detailed guidance for applying the pesticide properly
- provisions for contacting the certified applicator in the event he is needed.
In other situations, and as required by the label, the actual physical presence of a
certified applicator may be required when application is made by a noncertified
applicator.)
Verify that certified applicators whose activities indicate a supervisory role
demonstrate a practical knowledge of federal and state supervisory requirements,
including labeling, regarding the application of restricted use pesticides by
noncertified applicators.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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AGRICULTURAL
PESTICIDES
PM.70
Entry Restrictions
(NOTE: See the definitions for Excepted Agricultural Applications for Worker
Standards.)
PM.70.1. Employers must
satisfy certain requirements
when applying pesticides on a
farm or in a forest (40 CFR
Verify that, during treatments on a farm or in a forest, employees other than those
appropriately trained, do not enter or remain in the treated area.
PM.70.2. Employers must
satisfy certain requirements
when applying pesticides in a
nurseries (40 CFR
Verify that, when applications described in column A of Table 1 in Appendix E
take place in a nursery, employees other than those appropriately trained do not
enter or remain in the areas specified in column B of the table.
(NOTE: After the application is completed, the entry-restricted area is the treated
area, until the end of any restricted-entry interval.)
PM.70.3. Employers must
satisfy certain requirements
when applying pesticides in
greenhouses (40 CFR
Verify that, when applications described in column A of the table in Appendix F
take place in a greenhouse, employees other than those appropriately trained, do
not enter or remain in the areas described in column B until the time specified in
column C has expired.
Verify that no employee is allowed to enter or remain in the treated area as
specified in column D of after the time specified in column C, and until the
expiration of any restricted-entry interval, except as provided in 40 CFR 170.112
(see checklist items PM.70.4 through PM.70.11).
Verify that, when specified by column C, ventilation continues until the air
concentration is measured to be less than or equal to the inhalation exposure level
the labeling requires to be achieved.
Verify that, if no inhalation exposure is listed on the labeling, ventilation
continues until after:
- ten air exchanges are completed
- 2 h of ventilation using fans or other mechanical ventilating systems
- 4 h of ventilation using vents, windows or other passive ventilation
- 11 h with no ventilation followed by 1 h of mechanical ventilation
- 11 h with no ventilation followed by 2 h of passive ventilation, or
- 24 h with no ventilation.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.70.4. Employers are
required to meet specific
requirements concerning entry
into treated areas (40 CFR
Verify that the employer does not allow or direct any employee to enter or remain
in the treated area before the restricted-entry interval specified on the pesticide
labeling has expired.
(NOTE: Entry restricted areas in greenhouses are specified in column D of
Appendix F.)
Verify that when two or more pesticides are applied at the same time, the
restricted-entry interval is the longest of the applicable intervals.
Verify that the employer assures that any worker who enters a treated area under
an allowable restricted-entry interval, uses the PPE specified in the product
labeling for early-entry workers.
(NOTE: Entry-restricted areas in greenhouses are specified in column D in Table 2
of 40CFR170.100(c)(4)).
PM.70.5. Employees may
enter treated areas during a
restricted-entry interval
providing certain
requirements are met (40 CFR
Verify that only employees who meet the following criteria enter a treated area
during a restricted-entry interval:
- no contact is made with anything that has been treated with the pesticide to
which the restricted-entry interval applies, including, but not limited to, soil,
water, air, or surfaces of plants
- entry is not allowed until any inhalation exposure level listed in the labeling
has been reached or any ventilation criteria have been met.
PM.70.6. Employees
entering treated areas during a
restricted-entry interval for
short-term activity must
satisfy certain operational
requirements (40 CFR
170.104(a), 17
through 170.112(c)(5)).
Verify that employees who enter a treated area during a restricted-entry interval
for short-term activities satisfy the following requirements:
- no hand labor activity is performed
- the time in the treated area does not exceed 1 h in any 24-h period
- entry is not allowed until 4 h following the end of the application, and no
such entry is allowed thereafter until any inhalation exposure level listed in
the labeling has been reached or any ventilation criteria have been met
- the employee is provided with the PPE specified on the product labeling for
early entry.
Verify that the PPE provided to the employee for early entry conforms to the
following standards:
- when "chemical-resistant" PPE is specified, it is made of material that allows
no measurable movement of the pesticide the material during use
- when "waterproof PPE is specified, it is made of material that allows no
measurable movement of water or aqueous solutions through the material
during use
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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-when "chemical-resistant suit" is specified, it is loose-fitting, one- or two-
piece, chemical resistant garment that covers, at a minimum, the entire body
except head, hands, and feet
-when "coveralls" are specified, they are a loose-fitting, one- or two-piece
garment, such as a cotton or cotton and polyester coverall, that cover, at a
minimum, the entire body except head, hands, and feet
-when "chemical-resistant footwear" is specified it is a chemical-resistant
shoe, boot, or shoe coverings worn over shoes or boots
-when "protective eyewear" is specified, it is a goggle; face shield; safety
glasses with front, brow, and temple protection; or a full-face respirator
-when "chemical-resistant headgear" is specified, it is a chemical-resistant
hood or hat with a wide brim.
- gloves specified by the product labeling.
(NOTE: Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes,
socks, and other items of work clothing are not considered PPE in this instance
and are not subject to these requirements.)
(NOTE: The pesticide product labeling may specify that the coveralls be worn
over a layer of clothing. If a chemical-resistant suit is substituted for coveralls, it
need not be worn over a layer of clothing. If chemical-resistant footwear with
sufficient durability and a tread appropriate for wear in rough terrain is not
obtainable for workers, then leather boots may be worn in such terrain.)
Verify that gloves or glove linings worn for early-entry activities are not made of
leather, cotton, or other absorbent materials, unless these materials are listed on
the product labeling as acceptable for such use.
(NOTE: If chemical-resistant gloves with sufficient durability and suppleness are
not obtainable for tasks with roses or other plants with sharp thorns, leather gloves
may be worn over chemical-resistant liners.)
Verify that once leather gloves have been worn for tasks with roses or other plants
with sharp thorns, thereafter, they are worn only with chemical-resistant liners and
not for any other use.
Verify that, before entering the treated area, employees read or are informed of
information on the product labeling, in a manner that they understand, of all
labeling requirements related to:
- human hazards or precautions
- first aid
- symptoms of poisoning
- PPE specified for early entry
- any other labeling requirements related to safe use.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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(NOTE: The requirement to ensure employees read or are informed of information
on the product labeling does not apply to the owner, or the immediate family of an
owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
PM.70.7. Employers are
required to ensure that
employees entering treated
areas during a restricted-entry
interval for short-term activity
satisfy certain PPE
management requirements (40
CFR 170.104(a) and
Verify that employees wear protective equipment correctly for its intended
purpose and use it according to manufacturer's instructions.
Verify that, before each day of use, all PPE is inspected for leaks, holes, tears, or
worn places any damaged equipment is repaired or discarded.
Verify that PPE that cannot be cleaned properly is disposed of in accordance with
any applicable federal, state, and local regulations.
Verify that all PPE is cleaned according to manufacturer's instructions or pesticide
product labeling instructions before each day of reuse.
Verify that in the absence of any manufacturer's instructions, it is washed
thoroughly in detergent and hot water.
Verify that, before being stored, all clean PPE is dried thoroughly or is put in a
well-ventilated place to dry.
Verify that PPE contaminated with pesticides is kept separately and washed
separately from any other clothing or laundry.
Verify that any person who cleans or launders PPE is informed that such
equipment may be contaminated with pesticides, and of the potentially harmful
effects of exposure to pesticides.
Verify that any person who cleans or launders PPE is informed of the correct way
to handle and clean such equipment, and to protect themselves when handling
equipment contaminated with pesticides.
Verify that all clean PPE is stored separately from personal clothing and apart
from pesticide-contaminated areas.
Verify that each worker is instructed how to put on, use, and remove the PPE.
Verify that each worker is informed about the importance of washing thoroughly
after removing PPE.
Verify that each worker is instructed in the prevention, recognition, and first aid
treatment of heat-related illness.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Verify that workers have a clean place away from pesticide-storage and pesticide-
use areas for storing personal clothing not in use.
Verify that workers have a clean place away from pesticide-storage and pesticide-
use areas for putting on PPE at the start of any exposure period, and removing
PPE at the end of any exposure period.
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
PM.70.8. Employers must
take certain precautions to
prevent heat-related illness
among employees entering
treated areas during a
restricted-entry interval for
short-term activity (40 CFR
170.104(a) and
Verify that, when PPE is required by the labeling of any pesticide for early entry,
no worker is allowed or directed to perform the early-entry activity without
implementing, when appropriate, measures to prevent heat-related illness.
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
PM.70.9. Employers must
provide a decontamination
site during early-entry activity
(40 CFR 170.104(a) and
Verify that, during any early-entry activity, the employer provides a
decontamination site in accordance with 40 CFR 170.150 (see checklist item
PM.90.1).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
PM.70.10. Employers must
not permit employees entering
treated areas during a
restricted-entry interval for
short-term activity to wear or
take home PPE contaminated
with pesticides (40 CFR
170.104(a) and
Verify that the employer does not allow or direct any worker to wear home or to
take home PPE contaminated with pesticides.
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.70.11. Employees may
enter treated areas under a
restricted-entry interval in an
agricultural emergency if
employers meet certain
criteria (40 CFR 170.112(d)
Verify that any worker who enters a treated area under a restricted-entry interval in
an agricultural emergency to perform tasks, including hand labor tasks, necessary
to mitigate the effects of the agricultural emergency, does so only if the
agricultural employer assures that all the following criteria are met:
- a state, tribal, or federal agency having jurisdiction declares the existence of
circumstances that could cause an agricultural emergency on that agricultural
establishment
-the agricultural establishment is subject to circumstances that result in an
agricultural emergency (see definition section for "agricultural emergency.")
-the requirements of 40 CFR 170.112(c)(3) through (c)(9) (see checklist items
PM.70.6 through PM.70.9) are met.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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AGRICULTURAL
PESTICIDES
PM.80
Worker Notification and
Training
(NOTE: See the definitions for Excepted Agricultural Applications for Worker
Standards.)
PM.80.1. Agricultural
employers are required notify
workers of pesticide
applications in greenhouses
(40 CFR 170.104(a),
170.120(a), 172.120(c), and
172.120(d)).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that all pesticide applications are posted as follows:
- the warning sign has a background color that contrasts with red
-the words "DANGER" and "PELIGRO," plus "PESTICIDES" and
"PESTICIDAS," are at the top of the sign
-the words "KEEP OUT" and "NO ENTRE" are at the bottom of the sign
- letters for all words are clearly legible
- a circle containing an upraised hand on the left and a stern face on the right is
near the center of the sign and the following are met:
- the inside of the circle is red, except that the hand and a large portion of
the face is in a shade that contrasts with red
-the length of the hand is at least twice the height of the smallest letters
- the length of the face is only slightly smaller than the hand
-the standard sign is at least 14 in. by 16 in. with letters at least 1 in. in height
(NOTE: Additional information may appear on the warning sign if it does not
detract from the appearance of the sign or change the meaning of the required
information.)
(NOTE: In greenhouses, the agricultural employer may, at any time, use a sign
smaller than the standard sign, but when a smaller sign is used, the following are
met:
- if a sign is used with DANGER and PELIGRO in letters at least 7/8 in. in
height and the remaining letters at least 1/2 in. in height and a red circle at
least 3 in. in diameter containing an upraised hand and a stern face, the signs
are no further than 50 ft apart
-if a sign is used with DANGER and PELIGRO in letters at least 7/16 in. in
height and the remaining letters at least 1/4 in. in height and a red circle at
least 1 1/2 in. in diameter containing an upraised hand and a stern face, the
signs are no further than 25 ft apart.)
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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(NOTE: The employer may replace the Spanish portion of the warning sign with a
non-English language read by the largest group of workers who do not read
English. The replacement sign must be in the same format as the original sign and
be visible and legible.)
Verify that, in greenhouses, the signs are posted so they are visible from all usual
points of worker entry to the treated area, including each aisle or other walking
route that enters the treated area.
Verify that when there are no usual points of worker entry to the treated area, signs
are posted in the corners of the treated area, or in any other location affording
maximum visibility.
Verify that the signs:
-are posted no sooner than 24 h before the scheduled application of the
pesticide
- remain posted throughout the application and any restricted-entry interval
- are removed within 3 days after the end of the application and any restricted-
entry interval and before agricultural-worker entry is permitted, other than
entry permitted by 40 CFR 170.112 (see checklist items PM.70.4 through
PM.70.11).
Verify that the signs remain visible and legible during the time they are posted.
(NOTE: When several contiguous areas are to be treated with pesticides on a
rotating or sequential basis, the entire area may be posted. But, worker entry,
other than entry permitted by 40 CFR 170.112 (see checklist items PM.70.4
through PM.70.11), is prohibited for the entire area while the signs are posted.)
Verify that, if the pesticide product labeling has a statement requiring both the
posting of treated areas and oral notification to workers, the employer also
provides oral notification as follows:
- notification is in a manner that the worker can understand
- if a worker will be on the premises during the application, the warning is
given before the application takes place or at the beginning of the worker's
first work period during which the application is taking place or the
restricted-entry interval for the pesticide is in effect
- the warning consists of:
-the location and description of the treated area
- the time during which entry is restricted
-instructions not to enter the treated area until the restricted-entry
interval has expired.
(NOTE: Notice need not be given to a worker if the employer can assure that one
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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of the following is met:
- from the start of the application until the end of the application and during
any restricted-entry interval, the worker will not enter, work in, remain in, or
pass through the greenhouse
- the worker applied (or supervised the application of) the pesticide for which
the notice is intended and is aware of all oral warnings.)
PM.80.2. Agricultural
employers are required to
notify workers of pesticide
applications on farms, in
nurseries, or in forests (40
CFR 170.104(a), 170.120(b),
172.120(c), and!72.120(d)).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that, if required by the pesticide label, both oral notification is given and
signs are posted.
(NOTE: For any pesticide other than those for which the labeling requires both
posting and oral notification of applications, the agricultural employer shall give
notice of the application to the worker either by the posting of warning or orally,
and shall inform the workers as to which method of notification is in effect.)
Verify that all pesticide applications are posted as follows:
- the warning sign has a background color that contrasts with red
-the words "DANGER" and "PELIGRO," plus "PESTICIDES" and
"PESTICIDAS," are at the top of the sign
-the words "KEEP OUT" and "NO ENTRE" are at the bottom of the sign
- letters for all words are clearly legible
- a circle containing an upraised hand on the left and a stern face on the right is
near the center of the sign and the following are met:
- the inside of the circle is red, except that the hand and a large portion of
the face is in a shade that contrasts with red
-the length of the hand is at least twice the height of the smallest letters
- the length of the face is only slightly smaller than the hand
-the standard sign is at least 14 in. by 16 in. with letters at least 1 in. in height
(NOTE: Additional information may appear on the warning sign if it does not
detract from the appearance of the sign or change the meaning of the required
information.)
Verify that farms and forests use the standard size unless a smaller sign is
necessary because the treated area is too small to accommodate a sign of at least
14 in. by 16 in..
(NOTE: In nurseries, the agricultural employer may, at any time, use a sign
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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smaller than the standard sign, but when a smaller sign is used, the following are
met:
- if a sign is used with DANGER and PELIGRO in letters at least 7/8 in. in
height and the remaining letters at least 1/2 in. in height and a red circle at
least 3 in. in diameter containing an upraised hand and a stern face, the signs
are no further than 50 ft apart
-if a sign is used with DANGER and PELIGRO in letters at least 7/16 in. in
height and the remaining letters at least 1/4 in. in height and a red circle at
least 1 1/2 in. in diameter containing an upraised hand and a stern face, the
signs are no further than 25 ft apart.)
(NOTE: The employer may replace the Spanish portion of the warning sign with a
non-English language read by the largest group of workers who do not read
English. The replacement sign must be in the same format as the original sign and
be visible and legible.)
Verify that, on farms and in forests and nurseries, the signs are visible from all
usual points of worker entry to the treated area, including at least all of the
following:
- each access road
- each border with any labor camp adjacent to the treated area
- each footpath and other walking route that enters the treated area
-when there are no usual points of worker entry, signs are posted in the
corners of the treated area or in any other location affording maximum
visibility.
Verify that the signs:
-are posted no sooner than 24 h before the scheduled application of the
pesticide
- remain posted throughout the application and any restricted-entry interval
- are removed within 3 days after the end of the application and any restricted-
entry interval and before agricultural-worker entry is permitted, other than
entry permitted by 40 CFR 170.112 (see checklist items PM.70.4 through
PM.70.11).
Verify that the signs remain visible and legible during the time they are posted.
(NOTE: When several contiguous areas are to be treated with pesticides on a
rotating or sequential basis, the entire area may be posted. But, worker entry,
other than entry permitted by 40 CFR 170.112 (see checklist items PM.70.4
through PM.70.11), is prohibited for the entire area while the signs are posted.)
Verify that, if the pesticide product labeling has a statement requiring both the
posting of treated areas and oral notification to workers, the employer also
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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provides oral notification as follows:
- notification is in a manner that the worker can understand
- if a worker will be on the premises during the application, the warning is
given before the application takes place or at the beginning of the worker's
first work period during which the application is taking place or the
restricted-entry interval for the pesticide is in effect
- the warning consists of:
-the location and description of the treated area
- the time during which entry is restricted
-instructions not to enter the treated area until the restricted-entry
interval has expired.
(NOTE: Notice need not be given to a worker if the employer can assure that one
of the following is met:
- from the start of the application until the end of the application and during
any restricted-entry interval, the worker will not enter, work in, remain in, or
pass through on foot the treated area or any area within 1/4 mi of the treated
area
- the worker applied (or supervised the application of) the pesticide for which
the notice is intended and is aware of all oral warnings.)
PM.80.3. Agricultural
employers are required to
display specific information
when a pesticide has been
applied on the establishment
or a restricted-entry interval
has been in effect (40 CFR
170.104(a)andl70.122).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that, if a pesticide has been applied on the establishment or a restricted-
entry interval has been in effect within the last 30 days, the following information
is displayed:
- the location and description of the treated area
- the product name, U.S. EPA registration number, and active ingredient(s) of
the pesticide
- the time and date the pesticide is to be applied
- the restricted-entry interval for the pesticide.
Verify that the information is displayed in the location specified for the pesticide
safety poster and is accessible and legible.
Verify that, if warning signs are posted for the treated area before an application,
the specific application information for that application is posted at the same time
or earlier.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Verify that the required information is posted before the application takes place, if
workers will be on the establishment during application or posted at the beginning
of any worker's first work period.
Verify that the information continues to be displayed for at least 30 days after the
end of the restricted-entry interval (or, if there is no restricted-entry interval, for at
least 30 days after the end of the application) or at least until workers are no longer
on the establishment, whichever is earlier.
PM.80.4. Agricultural
employers must provide
specific information to
handler employers (40 CFR
170.124)
Verify that whenever handlers who are employed by a commercial pesticide
handling establishment are performing pesticide handling tasks on an agricultural
establishment, the employer provides to the handler employer, or assures that the
handler employer is aware of, the following information concerning any areas on
the agricultural establishment that the handler may be in (or may walk within 1/4
mile of) and that may be treated with a pesticide or that may be under a restricted-
entry interval while the handler will be on the agricultural establishment:
- specific location and description of any such areas
- restrictions on entering those areas.
PM.80.5. Agricultural
employers must provide
pesticide safety training for
certain workers (40 CFR
170.104(a), 170.130(a), and
170.130(b)).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that each worker, has been trained during the last 5 yr, counting from the
end of the month in which the training was completed.
Verify that, workers have received safety information training before a worker
enters any areas on the agricultural establishment where, within the last 30 days a
pesticide has been applied or the restricted-entry interval for such pesticide has
been in effect.
Verify that the pesticide safety information training is done in a manner that
agricultural workers can understand, such as by providing written materials, or
oral communication, or by other means.
Verify that workers are trained before the 6th day that they enter any areas on the
agricultural establishment where, within the last 30 days a pesticide has been
applied or a restricted-entry interval for such pesticide has been in effect.
(NOTE: The exception to the safety information and 6th day training
requirements is that workers are required to be trained before entering a treated
area on the agricultural establishment during a restricted-entry interval to perform
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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early-entry activities and contacting anything that has been treated with the
pesticide to which the restricted-entry interval applies, including but not limited to,
soil, water, or surfaces of plants.)
(NOTE: The following persons need not be trained under this section:
- a worker who is currently certified as an applicator of restricted-use
pesticides
- a worker who satisfies the training requirements of 40 CFR 171 (see
checklist items PM.60.1 through PM.60.3 )
- a worker who satisfies the handler training requirements of 40 CFR
170.230(c) (see checklist item PM. 120.4)
- a worker who is certified or licensed as a crop advisor by a program
acknowledged as appropriate in writing by U.S. EPA or a state or Tribal lead
agency for pesticide enforcement, provided that a requirement for such
certification or licensing is pesticide safety training that includes the required
minimum safety content (see checklist item PM. 120.4.)
PM.80.6. Pesticide safety
information training is
required to meet specific
parameters (40 CFR
172.104(a), 172.130(c), and
172.130(d)).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that, at a minimum, the following pesticide safety information is provided:
- pesticides may be on or in plants, soil, irrigation water, or drifting from
nearby applications
- prevent pesticides from entering your body by:
- following directions and/or signs about keeping out of treated or
restricted areas
- washing before eating, drinking, using chewing gum or tobacco, or
using the toilet
- wearing work clothing that protects the body from pesticide residues
- washing/showering with soap and water, shampoo hair, and put on
clean clothes after work
- washing work clothes separately from other clothes before wearing
them again
- washing immediately in the nearest clean water if pesticides are spilled
or sprayed on the body and as soon as possible, shower, shampoo, and
change into clean clothes
- further training is provided within 5 days
Verify that general pesticide safety information is presented to workers either
orally from written materials or audiovisually such that:
- the information is presented in a manner that the workers can understand
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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(such as through a translator) using nontechnical terms
- the presenter responds to workers' questions.
Verify that the person who conducts the training meets at least one of the
following criteria:
- is currently certified as an applicator of restricted-use pesticides
- is currently designated as a trainer of certified applicators or pesticide
handlers by a state, federal, or tribal agency having jurisdiction
- has completed a pesticide safety train-the-trainer program approved by a
state, federal, or tribal agency having jurisdiction
- satisfies the training requirements in 40 CFR 171 (see checklist items
PM.60.1 through PM.60.3) or in 40 CFR 170.230(c) (see checklist item
PM. 120.4)
Verify that the worker who receives an U.S. EPA-approved Worker Protection
Standard worker training certificate has been trained in accordance with 40 CFR
170.130(c)(4).
Verify that training materials convey, at a minimum, the following information:
- where and in what form pesticides may be encountered during work activities
- hazards of pesticides resulting from toxicity and exposure, including acute
and chronic effects, delayed effects, and sensitization
- routes through which pesticides can enter the body
- signs and symptoms of common types of pesticide poisoning
- emergency first aid for pesticide injuries or poisonings
- how to obtain emergency medical care
- routine and emergency decontamination procedures, including emergency
eyeflushing techniques
- hazards from chemigation and drift
- hazards from pesticide residues on clothing.
- warnings about taking pesticides or pesticide containers home.
-requirements of 40 CFR 170.102 through 40 CFR 170.160 designed to
reduce the risks of illness or injury resulting from workers' occupational
exposure to pesticides, including:
- application and entry restrictions
- the design of the warning sign
- posting of warning signs
- oral warnings
- the availability of specific information about applications, and the
protection against retaliatory acts.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM.80.7. Agricultural
employers must post certain
pesticide safety information
when pesticides have been
applied or a restricted-entry
interval has been in effect (40
CFR 170.104(a) and 170.135)
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that, when workers are on an agricultural establishment and, within the last
30 days a pesticide has been applied on the establishment or a restricted-entry
interval has been in effect, the agricultural employer displays pesticide safety
information.
Verify that a safety poster is displayed that conveys, at a minimum, the following
basic pesticide safety concepts:
- to help keep pesticides from entering your body, at a minimum, the following
points are conveyed:
- avoid getting on your skin or into your body any pesticides that may be
on plants and soil, in irrigation water, or drifting from nearby
applications
- wash before eating, drinking, using chewing gum or tobacco, or using
the toilet
- wear work clothing that protects the body from pesticide residues (long-
sleeved shirts, long pants, shoes and socks, and a hat or scarf)
- wash/shower with soap and water, shampoo hair, and put on clean
clothes after work
- wash work clothes separately from other clothes before wearing them
again
- wash immediately in the nearest clean water if pesticides are spilled or
sprayed on the body and as soon as possible, shower, shampoo, and
change into clean clothes
- follow directions about keeping out of treated or restricted areas
- there are federal rules to protect workers and handlers, including a
requirement for safety training.
Verify that the name, address, and telephone number of the nearest emergency
medical care facility is on the safety poster or displayed close to the safety poster.
Verify that the employer informs workers promptly of any change to the
information on emergency medical care facilities
Verify that the pesticide safety information is displayed in a central location on the
farm or in the nursery or greenhouse where it can be readily seen and read by
workers.
Verify that the pesticide safety information is displayed in a location in or near the
forest in a place where it can be readily seen and read by workers and where
workers are likely to congregate or pass by, such as at a decontamination site or an
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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equipment storage site.
Verify that workers are informed of the location of the pesticide safety information
and are allowed access to it.
Verify that the pesticide safety information remains legible during the time it is
posted.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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AGRICULTURAL
PESTICIDES
PM.90
Operations
(NOTE: See the definition for Excepted Agricultural Applications for Worker
Standards.)
PM.90.1. Agricultural
employers must provide
decontamination supplies that
satisfy certain requirements
(40 CFR 170.104(a) and
170.150).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that the agricultural employer provides decontamination supplies for
workers whenever the following conditions are met:
- any worker on the agricultural establishment is performing an activity in the
area where a pesticide was applied or a restricted-entry interval (REI) was in
effect within the last 30 days
- the worker contacts anything that has been treated with the pesticide,
including, but not limited to soil, water, plants, plant surfaces, and plant
parts.
(NOTE: The 30-day time period does not apply if the only pesticides used in the
treated area are products with an REI of 4 h or less on the label (but not a product
without an REI on the label).)
Verify that, the agricultural employer provides decontamination supplies for not
less than 7 days following the expiration of any applicable REI when workers are
in treated areas where the only pesticides used are products with an REI of 4 h or
less on the label.
Verify that the agricultural employer provides workers with enough water for
routine washing and emergency eyeflushing.
Verify that, at all times when water is available to workers, it is of a quality and
temperature that will not cause illness or injury when it contacts the skin or eyes or
if it is swallowed.
Verify that, when water stored in a tank is to be used for mixing pesticides, it is not
used for decontamination or eyeflushing, unless the tank is equipped with properly
functioning valves or other mechanisms that prevent movement of pesticides into
the tank.
Verify that the agricultural employer provides soap and single-use towels in
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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quantities sufficient to meet worker's needs.
Verify that, for emergency eyeflushing, the agricultural employer provides at least
1 pint of water which is immediately available to each worker who is performing
permitted early-entry activities and for which the pesticide labeling requires
protective eyewear.
Verify that the eyeflush water is carried by the early-entry worker, or is on the
vehicle the early-entry worker is using, or otherwise immediately accessible.
Verify that the decontamination supplies are located together and are reasonably
accessible to and not more than 1/4 mi from where workers are working.
Verify that the decontamination supplies are not maintained in an area being
treated with pesticides.
Verify that the decontamination supplies are not maintained in an area that is
under a REI, unless the workers for whom the supplies are provided are
performing permitted early-entry activities and involving contact with treated
surfaces and the decontamination supplies would otherwise not be reasonably
accessible to those workers.
Verify that, at the end of any exposure period for workers engaged in permitted
early-entry activities and involving contact with anything that has been treated
with the pesticide to which the REI applies, including, but not limited to, soil,
water, air, or surfaces of plants, the agricultural employer provides, at the site
where the workers remove PPE, soap, clean towels, and a sufficient amount of
water so that the workers may wash thoroughly.
(NOTE: For worker activities performed more than 1/4 mi from the nearest place
of vehicular access:
-the soap, single-use towels, and water may be at the nearest place of
vehicular access
-the agricultural employer may permit workers to use clean water from
springs, streams, lakes, or other sources for decontamination at the remote
work site, if such water is more accessible than the water located at the
nearest place of vehicular access.)
PM.90.2. Agricultural
employers must provide
assistance to workers who
have been poisoned or injured
by exposure to pesticides use
(40 CFR 170.104(a) and
170.160).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are performing tasks related to the
production of agricultural plants on their own agricultural establishment. But, this
protection must be provided to other workers and members who are not members
of the immediate family.)
Verify that, if there is reason to believe that a person who is or has been employed
on an agricultural establishment to perform tasks related to the production of
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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agricultural plants has been poisoned or injured by exposure to pesticides used on
the agricultural establishment, including, but not limited to, exposures from
application, splash, spill, drift, or pesticide residues, the agricultural employer:
- makes available to that person prompt transportation from the agricultural
establishment, including any labor camp on the agricultural establishment, to
an appropriate emergency medical facility
-provides to that person, or to treating medical personnel, promptly upon
request, any obtainable information on:
-product name, U.S. EPA registration number, and active ingredients of
any product to which that person might have been exposed
- antidote, first aid, and other medical information from the
- product labeling
-the circumstances of application or use of the pesticide on the
agricultural establishment
-the circumstances of exposure of that person to the pesticide
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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AGRICULTURAL
PESTICIDES
PM.120
Pesticide Handlers
(NOTE: See the definitions for Excepted Agricultural Applications for Handler
Standards.)
(NOTE: The requirements for pesticide handlers do not apply when any pesticide
is applied on an agricultural establishment in the following circumstances:
- for mosquito abatement, Mediterranean fruit fly eradication, or similar wide-
area public pest control programs sponsored by governmental entities
- on livestock or other animals, or in or about animal premises
- on plants grown for other than commercial or research purposes, which may
include plants in habitations, home fruit and vegetable gardens, and home
greenhouses
- on plants that are in ornamental gardens, parks, and public or private lawns
and grounds and that are intended only for aesthetic purposes or climatic
modification
-in a manner not directly related to the production of agricultural plants,
including, but not limited to, structural pest control, control of vegetation
along rights-of-way and in other noncrop areas, and pasture and rangeland
use
-for control of vertebrate pests
- as attractants or repellents in traps
- on the harvested portions of agricultural plants or on harvested timber
-for research uses of unregistered pesticides.)
PM.120.1. Handler
employers and handlers are
required to take certain
precautions during pesticide
applications (40 CFR
170.204(a) and 170.210).
Verify that the handler employer and the handler do not apply pesticides so as to
contact, either directly or through drift, any worker or other person, other than an
appropriately trained and equipped handler.
Verify that, any handler who is performing any handling activity with a product
that has the skull and crossbones symbol on the front panel of the label is
monitored visually or by voice communication at least every 2 h.
Verify that any handler who handles a fumigant in a greenhouse, including a
handler who enters the greenhouse before the acceptable inhalation exposure level
or ventilation criteria have been met, to monitor air levels or to initiate ventilation,
maintains continuous visual or voice contact with another handler.
Verify that the other handler present during applications in a greenhouse has
immediate access to the PPE required by the fumigant labeling for handlers in the
event entry into the fumigated greenhouse becomes necessary for rescue.
(NOTE: The requirements related to fumigants and products with a skull and
crossbones do not apply to the owner, or the immediate family of an owner of an
agricultural establishment who are performing handling tasks on their own
agricultural establishment. But, this protection must be provided to other workers
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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and members who are not members of the immediate family.)
PM. 120.2. Handler
employers must provide
specific information about
pesticide applications (40
CFR 170.204(a) and
170.222).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that, when handlers (except those employed by a commercial pesticide
handling establishment) are on an agricultural establishment, and a pesticide has
been applied on the establishment within the last 30 days, or a restricted-entry
interval has been in effect, the handler employer displays information about the
pesticide.
Verify that the information is displayed in the same location as the safety poster
and accessible and legible.
Verify that, if warning signs are posted for the treated area before an application,
the specific application information for that application is posted at the same time
or earlier.
Verify that the information is posted before the application takes place, if handlers
(except those employed by a commercial pesticide handling establishment) will be
on the establishment during application, or posted at the beginning of any such
handler's first work period
Verify that the information is displayed for at least 30 days after the end of the
restricted-entry interval (or, if there is no restricted-entry interval, for at least 30
days after the end of the application) or at least until the handlers are no longer on
the establishment, whichever is earlier.
Verify that the displayed information includes all of the following:
-the location and description of the treated area
-the product name, U.S. EPA registration number, and active ingredient(s) of
the pesticide
- the time and date the pesticide is to be applied
- the restricted-entry interval for the pesticide
PM. 120.3. Handler
employers must provide
certain information to
agricultural employers prior to
pesticide applications (40
CFR 170.224)
Verify that, before the application of any pesticide on or in an agricultural
establishment, the handler employer provides the following information to any
agricultural employer for the establishment or assures that any agricultural
employer is aware of:
- specific location and description of the treated area
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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- time and date of application
-product name, U.S. EPA registration number, and active ingredient(s)
- restricted-entry interval
- whether posting and oral notification are required
- any other product-specific requirements on the product labeling concerning
protection of workers or other persons during or after application
PM. 120.4. Handlers must
satisfy certain safety training
prior to performing handling
tasks (40 CFR 170.204(a) and
170.230)
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that, before any handler performs any handling task, that handler has been
trained during the last 5 yr, counting from the end of the month in which the
training was completed.
Verify that general pesticide safety information is presented to handlers either
orally from written materials or audiovisually.
-the information is presented in a manner that the handlers can understand
(such as through a translator)
- the presenter responds to handlers' questions
Verify that the person who conducts the training meets at least one of the
following criteria:
- is currently certified as an applicator of restricted-use pesticides under 40
CFR 171 (see checklist items PM.60.1 through PM.60.3)
-is currently designated as a trainer of certified applicators or pesticide
handlers by a state, federal, or tribal agency having jurisdiction
-has completed a pesticide safety train-the-trainer program approved by a
state, federal, or tribal agency having jurisdiction
Verify that the pesticide safety training materials conveys, at a minimum, the
following information:
-format and meaning of information contained on pesticide labels and in
labeling, including safety information such as precautionary statements about
human health hazards
- hazards of pesticides resulting from toxicity and exposure, including acute
and chronic effects, delayed effects, and sensitization
- routes by which pesticides can enter the body
- signs and symptoms of common types of pesticide poisoning
- emergency first aid for pesticide injuries or poisonings
- how to obtain emergency medical care
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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- routine and emergency decontamination procedures
- need for and appropriate use of PPE
- prevention, recognition, and first aid treatment of heat-related illness
-safety requirements for handling, transporting, storing, and disposing of
pesticides, including general procedures for spill cleanup
- environmental concerns such as drift, runoff, and wildlife hazards
- warnings about taking pesticides or pesticide containers home
-requirements of this 40 CFR 170.202 through 40 CFR 170.260 that must be
followed by handler employers for the protection of handlers and other
persons, including the prohibition against applying pesticides in a manner
that will cause contact with workers or other persons, the requirement to use
PPE, the provisions for training and decontamination, and the protection
against retaliatory acts.
(NOTE: The following persons need not be trained:
-a handler who is currently certified as an applicator of restricted-use
pesticides under 40 CFR 171 (see checklist items PM.60.1 through PM.60.3)
-a handler who satisfies the training requirements of 40 CFR 171 (see
checklist items PM.60.1 through PM.60.3)
-a handler who is certified or licensed as a crop advisor by a program
acknowledged as appropriate in writing by U.S. EPA or a state or tribal lead
agency for pesticide enforcement, provided that a requirement for such
certification or licensing is pesticide safety training that includes the required
minimum safety content.)
PM. 120.5. The handler
employer is required to assure
that prior to the handler
performing any handling
activity, the handler either has
read the product labeling or
has been informed of all
labeling requirements related
to safe use of the pesticide (40
CFR 170.204(a) and
170.232).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that the handler employer assures that before the handler performs any
handling activity, the handler either has read the product labeling or has been
informed in a manner the handler can understand of all labeling requirements
related to safe use of the pesticide, such as signal words, human hazard
precautions, PPE requirements, first aid instructions, environmental precautions,
and any additional precautions pertaining to the handling activity to be performed.
Verify that the handler employer assures that the handler has access to the product
labeling information during handling activities.
(NOTE: Whenever a handler who is employed by a commercial pesticide
handling establishment will be performing pesticide handling tasks on an
agricultural establishment, the handler employer shall assure that the handler is
aware of the following information concerning any areas on the agricultural
establishment that the handler may be in (or may walk within 1/4 mi of) and that
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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may be treated with a pesticide or that may be under a REI while the handler will
be on the agricultural establishment:
- specific location and description of any such areas
- restrictions on entering those areas.)
PM. 120.6. The handler
employer is required to assure
that before the handler uses
any equipment, the handler is
instructed in the safe
operation of the equipment
(40 CFR 170.204(a) and
170.234).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that the handler employer assures that, before the handler uses any
equipment for mixing, loading, transferring, or applying pesticides, the handler is
instructed in the safe operation of such equipment, including, when relevant,
chemigation safety requirements and drift avoidance.
Verify that, before each day of use, equipment used for mixing, loading,
transferring, or applying pesticides is inspected for leaks, clogging, and worn or
damaged parts, and any damaged equipment is repaired or is replaced.
Verify that, before allowing any person to repair, clean, or adjust equipment that
has been used to mix, load, transfer, or apply pesticides, the handler employer
ensures that pesticide residues have been removed from the equipment.
(NOTE: The requirement for pesticide residues to be removed from equipment
does not apply if the person doing the cleaning, repairing, or adjusting is a handler
employed by the agricultural or commercial pesticide handling establishment.)
Verify that, if pesticide residue removal is not feasible, the person who repairs,
cleans, or adjusts the equipment is informed:
- equipment may be contaminated with pesticides
-of the potentially harmful effects of exposure to pesticides
- of the correct way to handle such equipment.
PM. 120.7. Handler
employers are required to
display certain safety
information (40 CFR
170.204(a) and 170.235).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that, when handlers (except those employed by a commercial pesticide
handling establishment) are on an agricultural establishment and, within the last 30
days, a pesticide has been applied on the establishment or a restricted-entry
interval has been in effect, the handler employer displays required pesticide safety
information.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Verify that a safety poster is displayed that conveys, at a minimum, the following
basic pesticide safety concepts:
- to help keep pesticides from entering your body, at a minimum, the following
points are conveyed:
- avoid getting on your skin or into your body any pesticides that may be
on plants and soil, in irrigation water, or drifting from nearby
applications
- wash before eating, drinking, using chewing gum or tobacco, or using
the toilet
- wear work clothing that protects the body from pesticide residues (long-
sleeved shirts, long pants, shoes and socks, and a hat or scarf)
- wash/shower with soap and water, shampoo hair, and put on clean
clothes after work
- wash work clothes separately from other clothes before wearing them
again
- wash immediately in the nearest clean water if pesticides are spilled or
sprayed on the body and as soon as possible, shower, shampoo, and
change into clean clothes
- follow directions about keeping out of treated or restricted areas
- there are federal rules to protect workers and handlers, including a
requirement for safety training.
Verify that the name, address, and telephone number of the nearest emergency
medical care facility is on the safety poster or displayed close to the safety poster.
Verify that the handler employer informs workers promptly of any change to the
information on emergency medical care facilities
Verify that the pesticide safety information is displayed in a central location on the
farm or in the nursery or greenhouse where it can be readily seen and read by
handlers.
Verify that the pesticide safety information is displayed in a location in or near the
forest in a place where it can be readily seen and read by workers and where
workers are likely to congregate or pass by, such as at a decontamination site or an
equipment storage site.
Verify that handlers are informed of the location of the pesticide safety
information and are allowed access to it.
Verify that the pesticide safety information remains legible during the time it is
posted.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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PM. 120.8. Pesticide handlers
are required to use the
clothing and PPE specified on
the labeling for use of a
product (40 CFR 170.204(a)
and 170.240).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that the PPE conforms to the following standards:
- when "chemical-resistant" PPE is specified, it is made of material that allows
no measurable movement of the pesticide the material during use
- when "waterproof PPE is specified, it is made of material that allows no
measurable movement of water or aqueous solutions through the material
during use
-when "chemical-resistant suit" is specified, it is loose-fitting, one- or two-
piece, chemical resistant garment that covers, at a minimum, the entire body
except head, hands, and feet
-when "coveralls" are specified, they are a loose-fitting, one- or two-piece
garment, such a cotton or cotton and polyester coverall, that cover, at a
minimum, the entire body except head, hands, and feet
- gloves are of the type specified by the product label
-when "chemical-resistant footwear" is specified it is a chemical-resistant
shoe, boot, or shoe coverings worn over shoes or boots
-when "protective eyewear" is specified, it is a goggle; face shield; safety
glasses with front, brow, and temple protection; or a full-face respirator
- when a "chemically-resistant apron" is specified, it is an apron that covers the
front of the body from mid-chest to the knees
- when a respirator is specified, it is appropriate for the product used and the
activity to be performed
-when "chemical-resistant headgear" is specified, it is a chemical-resistant
hood or hat with a wide brim.
(NOTE: Long-sleeved shirts, short-sleeved shirts, long pants, short pants, shoes,
socks, and other items of work clothing are not considered PPE in this instance
and are not subject to these requirements.)
(NOTE: The pesticide product labeling may specify that the coveralls be worn
over a layer of clothing. If a chemical-resistant suit is substituted for coveralls, it
need not be worn over a layer of clothing. If chemical-resistant footwear with
sufficient durability and a tread appropriate for wear in rough terrain is not
obtainable for workers, then leather boots may be worn in such terrain.)
Verify that gloves or glove linings made of leather, cotton, or other absorbant
material are not worn for handling activity unless they are listed on the product
labeled as acceptable for use.
(NOTE: If chemical-resistant gloves with sufficient durability and suppleness are
not obtainable for tasks with roses or other plants with sharp thorns, leather gloves
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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may be worn over chemical-resistant liners.)
Verify that once leather gloves have been worn for tasks with roses or other plants
with sharp thorns, thereafter, they are worn only with chemical-resistant liners and
not for any other use.
(NOTE: If handling tasks are performed using properly functioning systems that
enclose the pesticide to prevent it from contacting handlers or other persons, and if
such systems are used and are maintained in accordance with that manufacturer's
written operating instructions, exceptions to labeling-specified PPE for the
handling activity are permitted as follows:
- persons using a closed system to mix or load pesticides with a signal word of
DANGER or WARNING may substitute a long-sleeved shirt, long pants,
shoes, socks, chemical-resistant apron, and any protective gloves specified
on the labeling for handlers for the labeling-specified PPE
- persons using a closed system to mix or load pesticides other than those with
a signal word of DANGER or WARNING, or to perform other handling
tasks may substitute a long-sleeved shirt, long pants, shoes, and socks for the
labeling-specified PPE.)
Verify that persons using a closed system that operates under pressure wear
protective eyewear.
Verify that persons using a closed system have all labeling-specified PPE
immediately available for use in an emergency.
(NOTE: If handling tasks are performed from inside a cab that has a nonporous
barrier which totally surrounds the occupants of the cab and prevents contact with
pesticides outside of the cab, exceptions to PPE specified on the product labeling
for that handling activity are permitted as follows:
- persons occupying an enclosed cab may substitute a long-sleeved shirt, long
pants, shoes, and socks for the labeling-specified PPE. If a respiratory
protection device is specified on the pesticide product labeling for the
handling activity, it must be worn
- persons occupying an enclosed cab that has a properly functioning ventilation
system which is used and maintained in accordance with the manufacturer's
written operating instructions and which is declared in writing by the
manufacturer or by a governmental agency to provide respiratory protection
equivalent to or greater than a dust/mist filtering respirator may substitute a
long-sleeved shirt, long pants, shoes, and socks for the labeling-specified
PPE. If a respiratory protection device other than a dust/mist-filtering
respirator is specified on the pesticide product labeling, it must be worn
- persons occupying an enclosed cab that has a properly functioning ventilation
system which is used and maintained in accordance with the manufacturer's
written operating instructions and which is declared in writing by the
manufacturer or by a governmental agency to provide respiratory protection
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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equivalent to or greater than the vapor- or gas-removing respirator specified
on pesticide product labeling may substitute a long-sleeved shirt, long pants,
shoes, and socks for the labeling-specified PPE. If an air-supplying respirator
or a self-contained breathing apparatus (SCBA) is specified on the pesticide
product labeling, it must be worn
-persons occupying an enclosed cab shall have all labeling-specified PPE
immediately available and stored in a chemical-resistant container, such as a
plastic bag. They shall wear such PPE if it is necessary to exit the cab and
contact pesticide-treated surfaces in the treated area. Once PPE is worn in the
treated area, it must be removed before reentering the cab.)
Verify that chemical-resistant gloves are worn when entering or leaving an aircraft
contaminated by pesticide residues.
Verify that, in the cockpit, the gloves are kept in an enclosed container to prevent
contamination of the inside of the cockpit.
Verify that persons occupying an open cockpit use the PPE specified in the
product labeling for use during application, except that chemical-resistant
footwear need not be worn.
(NOTE: For aerial applications, a helmet may be substituted for chemical-resistant
headgear and a visor may be substituted for protective eyewear.)
(NOTE: Persons occupying an enclosed cockpit may substitute a long-sleeved
shirt, long pants, shoes, and socks for labeling-specified PPE.)
Verify that, if crop advisors entering treated areas while a restricted-entry interval
is in effect wear the PPE specified on the pesticide labeling for early-entry
activities instead of the PPE specified on the pesticide labeling for handling
activities, the following are met:
- application has been completed for at least 4 h
- any inhalation exposure level listed in the labeling has been reached or any
ventilation criteria established in the labeling have been met.
Verify that the handler employer assures that PPE is used correctly for its intended
purpose and is used according to the manufacturer's instructions.
Verify that, before each day of use, all PPE is inspected for leaks, holes, tears, or
worn places, and any damaged equipment is repaired or discarded.
Verify that all PPE is cleaned according to the manufacturer's instructions or
pesticide product labeling instructions before each day of reuse.
(NOTE: In the absence of any manufacturer's instructions, PPE shall be washed
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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thoroughly in detergent and hot water.)
Verify that, if any PPE cannot be cleaned properly, the handler employer disposes
of the PPE in accordance with any applicable federal, state, and local regulations.
(NOTE: Coveralls or other absorbent materials that have been drenched or
heavily contaminated with an undiluted pesticide that has the signal word
DANGER or WARNING on the label shall be not be reused.)
Verify that contaminated PPE is kept separately and washed separately from any
other clothing or laundry.
Verify that all clean personal PPE is either dried thoroughly before being stored or
is put in a well ventilated place to dry.
Verify that all PPE is stored separately from personal clothing and apart from
pesticide-contaminated areas.
Verify that, when dust/mist filtering respirators are used, the filters are replaced:
- when breathing resistance becomes excessive
- when the filter element has physical damage or tears
- according to manufacturer's recommendations or pesticide product labeling,
whichever is more frequent
- in the absence of any other instructions or indications of service life, at the
end of each day's work period.
Verify that when gas- or vapor-removing respirators are used, the gas- or vapor-
removing canisters or cartridges are replaced:
- at the first indication of odor, taste, or irritation
- according to manufacturer's recommendations or pesticide product labeling,
whichever is more frequent
- in the absence of any other instructions or indications of service life, at the
end of each day's work period.
Verify that the handler employer informs any person who cleans or launders PPE:
- such equipment may be contaminated with pesticides
-of the potentially harmful effects of exposure to pesticides
- of the correct way(s) to clean PPE and to protect themselves when handling
such equipment.
Verify that handlers have a clean place away from pesticide storage and pesticide
use areas where they may:
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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- store personal clothing not in use
- put on PPE at the start of any exposure period
- remove PPE at the end of any exposure period.
Verify that the handler employer does not allow or direct any handler to wear
home or to take home PPE contaminated with pesticides.
Verify that when the use of PPE is specified by the labeling of any pesticide for
the handling activity, the handler employer assures that no handler is allowed or
directed to perform the handling activity unless appropriate measures are taken, if
necessary, to prevent heat-related illness.
PM. 120.9. Appropriate
decontamination supplies are
required to be provided during
handling activity (40 CFR
170.204(a) and 170.250).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that the handler employer provides for handlers decontamination supplies
for washing off pesticides and pesticide residues.
Verify that handlers are provided with enough water for routine washing, for
emergency eyeflushing, and for washing the entire body in case of an emergency.
Verify that, at all times when the water is available to handlers, it is of a quality
and temperature that will not cause illness or injury when it contacts the skin or
eyes or if it is swallowed.
Verify that when water stored in a tank is to be used for mixing pesticides, it is not
used for decontamination or eye flushing, unless the tank is equipped with
properly functioning valves or other mechanisms that prevent movement of
pesticides into the tank.
Verify that the handler employer provides the following:
- soap and single-use towels in quantities sufficient to meet handlers' needs
- one clean change of clothing, such as coveralls, for use in an emergency.
Verify that decontamination supplies are located together and are reasonably
accessible to and not more than 1/4 mi from each handler during the handling
activity.
(NOTE: The following are exceptions for supply location:
- for mixing activities, decontamination supplies shall be at the mixing site
- decontamination supplies for a pilot who is applying pesticides aerially is in
the airplane or at the aircraft loading site
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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-when handling activities are performed more than 1/4 mi from the nearest
place of vehicular access:
- the soap, single-use towels, clean change of clothing, and water may be
at the nearest place of vehicular access
-the handler employer may permit handlers to use clean water from
springs, streams, lakes, or other sources for decontamination at the
remote work site, if such water is more accessible than the water located
at the nearest place of vehicular access.
Verify that the decontamination supplies are not in an area being treated with
pesticides or in an area under a restricted-entry interval, unless:
- the decontamination supplies are in the area where the handler is performing
handling activities
-the soap, single-use towels, and clean change of clothing are in enclosed
containers
- the water is running tap water or is enclosed in a container.
(NOTE: To provide for emergency eyeflushing, the handler employer shall assure
that at least 1 pint of water is immediately available to each handler who is
performing tasks for which the pesticide labeling requires protective eyewear. The
eyeflush water shall be carried by the handler, or shall be on the vehicle or aircraft
the handler is using, or shall be otherwise immediately accessible.)
Verify that, at the end of any exposure period, the handler employer provides, at
the site where handlers remove PPE, soap, clean towels, and a sufficient amount of
water so that the handlers may wash thoroughly.
PM.120.10. Handler
employers are required to take
certain actions to provide
emergency assistance (40
CFR 170.04(a) and 170.260).
(NOTE: These requirements do not apply to the owner, or the immediate family of
an owner of an agricultural establishment who are handling tasks related on their
own agricultural establishment. But, this protection must be provided to other
workers and members who are not members of the immediate family.)
Verify that, if there is reason to believe that a person who is or has been employed
by an agricultural establishment or commercial pesticide handling establishment to
perform pesticide handling tasks has been poisoned or injured by exposure to
pesticides as a result of that employment, including, but not limited to, exposures
from handling tasks or from application, splash, spill, drift, or pesticide residues,
the handler employer:
-make available to that person prompt transportation from the place of
employment or the handling site to an appropriate emergency medical facility
-provide to that person or to treating medical personnel, promptly upon
request, any obtainable information on:
-product name, U.S. EPA registration number, and active ingredients of
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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any product to which that person might have been exposed
-antidote, first aid, and other medical information from the product
labeling
-the circumstances of handling of the pesticide
-the circumstances of exposure of that person to the pesticide.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Appendix A:
Exempted Pesticides (40 CFR 152.20 and 152.25)
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Exempted Pesticides
(40 CFR 152.20 and 152.25)
These pesticides are exempted from 40 CFR 152.
1. The following pesticides are exempt because it has been determined that they are adequately regulated by another
federal agency:
- all biological control agents are exempt from FIFRA requirements except the following:
- eucaryotic microorganisms, including protozoa, algae and fungi
- procaryotic microorganisms, including bacteria
-viruses
- a pesticide product that is offered solely for human use and also is a new drug within the meaning of FFDCA
sec. 201(p) or is an article that has been determined by the Secretary of Health and Human Services not to be a
new drug by a regulation establishing conditions of use for the article. Such products are subject to regulation
in accordance with the FFDCA and implementing regulations.)
2. The pesticides or classes of pesticides listed here have been determined to be of a character not requiring
regulation under FIFRA, and are therefore exempt from all provisions of FIFRA when intended for use, and used,
only in the manner specified.
a) Treated articles or substances. An article or substance treated with, or containing, a pesticide to protect the
article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood
products treated to protect the wood against insect or fungus infestation), if the pesticide is registered for such
use.
b) Pheromones and pheromone traps. Pheromones and identical or substantially similar compounds labeled for use
only in pheromone traps (or labeled for use in a manner which the U.S. EPA or authorized regulatory agency
determines poses no greater risk of adverse effects on the environment than use in pheromone traps), and
pheromone traps in which those compounds are the sole active ingredient(s).
- For the purposes of this paragraph, a pheromone is a compound produced by an arthropod which, alone or
in combination with other such compounds, modifies the behavior of other individuals of the same
species.
-For the purposes of this paragraph, a synthetically produced compound is identical to a pheromone only
when their molecular structures are identical, or when the only differences between the molecular
structures are between the stereochemical isomer ratios of the two compounds, except that a synthetic
compound found to have lexicological properties significantly different from a pheromone is not identical.
- When a compound possesses many characteristics of a pheromone but does not meet the criteria in
paragraph (a)(2) of this section, it may, after review by the Agency, be deemed a substantially similar
compound.
-For the purposes of this paragraph, a pheromone trap is a device containing a pheromone or an identical
or substantially similar compound used for the sole purpose of attracting, and trapping or killing, target
arthropods. Pheromone traps are intended to achieve pest control by removal of target organisms from
their natural environment and do not result in increased levels of pheromones or identical or substantially
similar compounds over a significant fraction of the treated area.
c) Preservatives for biological specimens.
- Embalming fluids.
- Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals,
museums and institutions of learning.
- Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.
d) Vitamin hormone products. Vitamin hormone horticultural products consisting of mixtures of plant hormones,
plant nutrients, inoculants, or soil amendments, which meet the following criteria:
- The product, in the undiluted package concentration at which it is distributed or sold, meets the criteria of
40 CFR 156.10(h)(l) of this chapter for Toxicity Category III or IV; and
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
- The product is not intended for use on food crop sites, and is labeled accordingly.
e) Foods. Products consisting of foods and containing no active ingredients, which are used to attract pests.
f) Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles (except cedar oil, or
formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture)
that meet all of the following criteria:
- The product consists totally of cedarwood or natural cedar.
- The product is not treated, combined, or impregnated with any additional substance(s).
- The product bears claims or directions for use solely to repel arthropods other than ticks or to retard
mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific
arthropods, or must exclude ticks if any general term such as "arthropods," "insects," "bugs," or any
other broad inclusive term, is used. The exemption does not apply to natural cedar products claimed to
repel ticks.
g) Products containing the following active ingredients are exempt from the requirements of FIFRA, alone or in
combination with other substances listed in this paragraph, provided that all of the criteria of this section are
met.
- Castor oil (U.S.P. or equivalent)
- Cedar oil
- Cinnamon and cinnamon oil
- Citric acid
- Citronella and citronella oil
- Cloves and clove oil
- Corn gluten meal
- Corn oil
- Cottonseed oil
- Dried blood
- Eugenol
- Garlic and garlic oil
- Geraniol
- Geranium oil
- Lauryl sulfate
- Lemongrass oil
- Linseed oil
- Malic acid
- Mint and mint oil
- Peppermint and peppermint oil
- 2-Phenethyl propionate (2-phenylethyl propionate)
- Potassium sorbate
- Putrescent whole egg solids
- Rosemary and rosemary oil
- Sesame (includes ground sesame plant) and sesame oil
- Sodium chloride (common salt)
- Sodium lauryl sulfate
- Soybean oil
- Thyme and thyme oil
- White pepper
- Zinc metal strips (consisting solely of zinc metal and impurities)
(NOTE: A pesticide product exempt under paragraph (g) may only include inert ingredients listed in the most
current List 4A. This list is updated periodically and is published in the Federal Register. The most current list
may be obtained by writing to Registration Support Branch (4A Inerts List) Registration Division (7505C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington DC 20460. All
of the following conditions must be met for products to be exempted under this section:
This document is intended solely for guidance. No statutory or regulatory A2
requirements are in any way altered by any statement(s) contained herein.
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- Each product containing the substance must bear a label identifying the name and percentage (by weight)
of each active ingredient and the name of each inert ingredient.
- The product must not bear claims either to control or mitigate microorganisms that pose a threat to human
health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or
rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.
- The product must not include any false and misleading labeling statements, including those listed in 40
CFR 156.10(a)(5)(i) through (viii).)
This document is intended solely for guidance. No statutory or regulatory A3
requirements are in any way altered by any statement(s) contained herein.
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This document is intended solely for guidance. No statutory or regulatory A4
requirements are in any way altered by any statement(s) contained herein.
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Appendix B:
Restricted-Use Pesticides (40 CFR 152.175)
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Restricted-Use Pesticides
(40 CFR 152.175)
The following uses of pesticide products containing the active ingredients specified below have been classified for
restricted use and are limited to use by or under the direct supervision of a certified applicator.
Active
Ingredient
Acrolein
Aldicarb
Aluminum phosphide
Azinphos methyl
Carbofuran
Chloropicrin
Clonitralid
Formulation
As sole active
ingredient. No
mixtures registered.
As sole active
ingredient.
No mixtures
registered.
As sole active
ingredient. No
mixtures registered.
All liquids with a
concentration greater
than 13.5%.
All other
formulations.
All concentrate
suspensions and
wettable powders
40% and greater.
All granular
formulations.
All granular and
fertilizer
formulations.
All formulations
greater than 2%.
All formulations.
All formulations 2%
and less.
All wettable powders
Use Pattern
All uses.
Ornamental uses
(indoor and
outdoor).
Agricultural crop
uses.
Agricultural crop
uses.
Agricultural crop
uses.
Agricultural crop
uses.
Agricultural crop
uses.
Rice.
All uses except rice.
All uses
Rodent control
Outdoor uses
(other than
rodent control).
All uses
Classification
Restricted.
Restricted.
Under further
evaluation.
Under further
evaluation.
Under further
evaluation.
Under further
evaluation.
Under further
evaluation.
Under
evaluation.
Under further
evaluation.
Under further
evaluation.
Under further
evaluation.
Unclassified.
Restricted
Criteria Influencing
Restriction
Inhalation hazard to
humans. Residue
effects on avian
species and aquatic
organisms
Other hazards-
accident history.
Inhalation hazard to
humans.
Inhalation hazard to
humans.
Acute inhalation
toxicity.
Acute inhalation
toxicity
Hazard to non-
target organisms.
Acute inhalation
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
Bl
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Active
Ingredient
Dicrotophos
Disulfoton
Ethoprop
Ethyl parathion
Formulation
70% and greater.
All granulars and
wettable powders.
Pressurized sprays
0.55% and less.
All liquid
formulations 8% and
greater.
All emulsifiable
concentrates 65% and
greater, all
emulsifiable
concentrates and
concentrate solutions
21% and greater with
fensulfothion 43%
and greater, all
emulsifiable
concentrates 32% and
greater in
combination with
32% fensulfothion
and greater.
Nonaqueous
solution 95% and
greater.
Granular
formulations 10%
and greater.
Emulsifiable
concentrates
40% and greater.
All granular and
fertilizer
formulations.
All granular and dust
formulations greater
than 2%, fertilizer
formulations,
wettable powders,
emulsifiable
Use Pattern
Molluscide uses.
Hospital antiseptics.
All uses.
All uses.
Commercial
seed treatment.
Indoor uses
(greenhouse).
Aquatic uses.
All uses.
All uses.
Classification
Restricted
Unclassified.
Restricted.
Restricted.
Restricted.
Restricted.
Restricted.
Under
evaluation.
Restricted.
Criteria Influencing
Restriction
toxicity.
Effects on aquatic
organisms.
Acute dermal
toxicity; residue
effects on avian
species (except for
tree injections).
Acute dermal
toxicity; residue
effects on avian
species (except for
tree injections).
Acute inhalation
toxicity.
Acute dermal
toxicity.
Acute inhalation
toxicity.
Acute dermal
toxicity.
Inhalation hazard to
humans. Acute
dermal toxicity.
Residue effects or
mammalian, aquatic,
avian species.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Active
Ingredient
Fenamiphos
Fonofos
Methamidophos
Methidathion
Methomyl
Formulation
concentrates,
concentrated
suspensions,
concentrated
solutions.
Smoke fumigants.
Dust and granular
formulations 2% and
below.
Emulsifiable
concentrates 35% and
greater.
Emulsifiable
concentrates 44% and
greater.
Emulsifiable
concentrates 12.6%
and less with
pebulate 50.3% and
less.
Liquid formulations
40% and greater.
Dust formulations
2. 5% and greater.
All formulations.
All formulations.
As sole active
ingredient in 1% to
2.5 baits (except 1%
fly bait).
All concentrated
solution formula-
tions.
Use Pattern
All uses.
All uses.
All uses.
All uses.
Tobacco.
Tobacco.
Tobacco.
All uses except
nursery stock
safflower and
sunflower.
Nursery stock,
safflower, and sun
flower.
Nondomestic out
doors agricultural
crops, ornamental
and turf. All other
registered uses.
Nondomestic out
doors agricultural
crops, ornamental
Classification
Restricted.
Restricted.
Restricted.
Restricted.
Unclassified.
Restricted.
Restricted.
Restricted.
Unclassified.
Restricted.
Restricted.
Criteria Influencing
Restriction
Inhalation hazard to
humans.
Other hazards-
accident history.
Acute dermal
toxicity.
Acute dermal
toxicity.
Acute dermal
toxicity; residue
effects an avian
species.
Residue effects an
avian species.
Residue effects on
avian species.
Residue effects on
mammalian species.
Other hazards-
accident history.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Active
Ingredient
Methyl bromide
Formulation
90% wettable powder
formulations (not in
water soluble bags).
90% wettable powder
formulation in water
soluble bags.
All granular formula-
tions.
25% wettable powder
formulations.
In 1.24% to 2.5%
dusts as sole active
ingredient and in
mixtures with
fungicides and
chlorinated
hydrocarbon,
inorganic phosphate
and biological
insecticides.
All formulations in
containers greater
than 1.5 Ib.
Containers with not
more than 1.5 Ib of
methyl bromide
with 0.25% to 2%
chloropicrin as an
indicator.
Containers with not
more than 1.5 Ib
having no indicator.
Use Pattern
and turf. All other
registered uses.
Nondomestic out
doors agricultural
crops, ornamental
and turf. All other
registered uses.
Nondomestic out
doors agricultural
crops, ornamental
and turf. All other
registered uses.
Nondomestic out
doors agricultural
crops, ornamental
and turf. All other
registered uses.
Nondomestic out
doors agricultural
crops, ornamental
and turf. All other
registered uses.
Nondomestic out
doors agricultural
crops, ornamental
and turf. All other
registered uses.
All uses.
Single applications
(nondomestic use)
for soil treatment in
closed systems.
All uses.
Classification
Restricted.
Unclassified.
Unclassified.
Unclassified.
Unclassified.
Restricted.
Unclassified.
Restricted.
Criteria Influencing
Restriction
Other hazards-
accident history.
Other hazards-
accident history.
Other hazards-
accident history.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Active
Ingredient
Methyl parathion
Nicotine
(alkaloid)
Paraquat (dichloride)
and paraquat
bis(methyl sulfate)
Formulation
All dust and granular
formulations less than
5%.
Microencapsulated.
All dust and granular
formulations 5% and
greater and all
wettable powders and
liquids.
Liquid and dry
formulations 14%
and above.
All formulations.
Liquid and dry
formulations 1.5%
and less.
All formulations and
concentrations except
those listed.
Pressurized spray
formulations
containing 0.44%
Paraquat bis(methyl
sulfate) and 15%
petroleum distillates
as active ingredients.
Liquid fertilizers
containing
concentrations of
0.025% paraquat
dichloride and 0.03%
atrazine; 0.03%
paraquat dichloride
and 0.37% atrazine,
0.04% paraquat
dichloride and 0.49%
atrazine.
Use Pattern
All uses.
All uses.
All uses.
Indoor (greenhouse)
Applications to
cranberries
All uses (domestic
and nondomestic).
All uses.
Spot weed and grass
control.
All uses.
Classification
Restricted.
Restricted.
Restricted.
Restricted.
Restricted.
Unclassified.
Restricted.
Restricted.
Unclassified.
Criteria Influencing
Restriction
Other hazards-
accident history. All
foliar applications
restricted based on
residue effects on
mammalian and avian
species.
Residue effects on
avian species. Hazard
to bees.
Acute dermal
toxicity. Residue
effects on mammalian
and avian species.
Acute inhalation
toxicity.
Effects on aquatic
organisms.
Other hazards. Use
and accident history,
human lexicological
data.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
B5
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Active
Ingredient
Phorate
Phosphamidon
Picloram
Sodium
cyanide3
Sodium fluoroacetate
Strychnine
Formulation
Liquid formulations
65% and greater.
All granular
formulations.
Liquid formulations
75% and greater.
Dust formulations
1.5% and greater.
All formulations and
concentrations except
tordon 101 R.
Tordon 101 R
forestry herbicide
containing 5.4%
picloram and 20.9%
2, 4-D.
All capsules and ball
formulations.
All solutions and dry
baits.
All dry baits pellets
and powder
formulations greater
than 0.5%.
Use Pattern
All uses.
Rice.
Rice.
Rice.
Rice.
Control of un-
wanted trees by cut
surface treatment.
All uses.
All uses.
All uses.
Classification
Restricted.
Restricted.
Restricted.
Restricted.
Restricted.
Unclassified.
Restricted.
Restricted.
Restricted.
Criteria Influencing
Restriction
Acute dermal
toxicity. Residue
effects on avian
species (applies to
foliar applications
only). Residue effects
on mammalian
species (applies to
foliar application
only).
Effects on aquatic
organisms.
Acute dermal
toxicity. Residue
effects on mammalian
species. Residue
effects on avian
species.
Acute dermal
toxicity. Residue
effects on mammalian
species. Residue
effects on avian
species.
Hazard to non-target
organisms
(specifically
nontarget plants both
crop and noncrop).
Inhalation hazard to
humans.
Acute oral toxicity.
Hazard to nontarget
organisms. Use and
accident history.
Acute oral toxicity.
Hazard to nontarget
avian species. Use
and accident history.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
B6
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Active
Ingredient
Sulfotepp
Zinc phosphide
Formulation
All dry baits, pellets,
and powder
formulations.
All dry baits, and
pellets, and powder
formulations 0.5%
and below.
All dry baits, and
pellets, and powder
formulations 0.5%
and below.
Sprays and smoke
generators.
All formulations 2%
and less.
All bait formulations
All dry formulation
10% and greater.
Use Pattern
All uses calling for
burrow builders.
All uses except
subsoil.
All subsoil uses.
All uses.
All domestic uses
and nondomestic
uses in and around
buildings.
Nondomestic out
door uses (other
than around
buildings).
Domestic uses.
Classification
Restricted.
Restricted.
Unclassified.
Restricted.
Unclassified.
Unclassified.
Unclassified.
Criteria Influencing
Restriction
Hazard to nontarget
organisms.
Hazard to nontarget
organisms.
Inhalation hazard to
humans.
Hazard to nontarget
organisms.
Acute oral toxicity.
Percentages given are the total of dioxathion plus related compounds.
3NOTE: M-44 sodium cyanide capsules may only be used by certified applicators who have also taken the required
additional training.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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This document is intended solely for guidance. No statutory or regulatory B8
requirements are in any way altered by any statement(s) contained herein.
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Appendix C:
General Standards for All Categories of Certified Commercial
Applicators (40 CFR 171.4(b))
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General Standards for All Categories of Certified Commercial Applicators
(40 CFR 171.4(b))
All commercial applicators shall demonstrate practical knowledge of the principles and practices of pest control and
safe use of pesticides. Testing shall be based on examples of problems and situations appropriate to the particular
category or subcategory of the applicator's certification and the following areas of competency:
Label and Labeling Comprehension:
1. The general format and terminology of pesticide labels and labeling;
2. The understanding of instructions, warnings, terms, symbols, and other information commonly
appearing on pesticide labels;
3. Classification of the product, general or restricted; and
4. Necessity for use consistent with the label.
Safety. Factors including:
1. Pesticide toxicity and hazard to man and common exposure routes;
2. Common types and causes of pesticide accidents;
3. Precautions necessary to guard against injury to applicators and other individuals in or near treated
areas;
4. Need for and use of protective clothing and equipment;
5. Symptoms of pesticide poisoning;
6. First aid and other procedures to be followed in case of a pesticide accident; and
7. Proper identification, storage, transport, handling, mixing procedures, and disposal methods for
pesticides and used pesticide containers, including precautions to be taken to prevent children from
having access to pesticides and pesticide containers.
Environment. The potential environmental consequences of the use and misuse of pesticides as may be
influenced by such factors as:
1. Weather and other climatic conditions;
2. Types of terrain, soil, or other substrate;
3. Presence offish, wildlife, and other non-target organisms; and
4. Drainage patterns.
Pests. Factors such as:
1. Common features of pest organisms and characteristics of damage needed for pest recognition;
2. Recognition of relevant pests; and
3. Pest development and biology as it may be relevant to problem identification and control.
Pesticides. Factors such as:
1. Types of pesticides;
2. Types of formulations;
3. Compatibility, synergism, persistence, and animal and plant toxicity of the formulations;
4. Hazards and residues associated with use;
5. Factors which influence effectiveness or lead to such problems as resistance to pesticides; and
6. Dilution procedures.
Equipment. Factors including:
1. Types of equipment and advantages and limitations of each type; and
2. Uses, maintenance, and calibration.
Application techniques. Factors including:
1. Methods of procedure used to apply various formulations of pesticides, solutions, and gases, together
with a knowledge of which technique of application to use in a given situation;
2. Relationship of discharge and placement of pesticides to proper use, unnecessary use, and misuse; and
This document is intended solely for guidance. No statutory or regulatory d
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
3. Prevention of drift and pesticide loss into the environment.
Laws and regulations.
1. Applicable state laws and regulations; and
2. Applicable federal laws and regulations.
This document is intended solely for guidance. No statutory or regulatory O2
requirements are in any way altered by any statement(s) contained herein.
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Appendix D:
Specific Standards for Competency for Each Category of
Certified Commercial Applicators
(40 CFR 171.4(c))
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Specific Standards for Competency for Each Category of Certified Commercial Applicators
(40 CFR 171.4(c))
Commercial applicators in each category shall be particularly qualified with respect to the practical knowledge
standards elaborated below:
• Agricultural pest control-Plant. Applicators must demonstrate practical knowledge of crops grown and
the specific pests of those crops on which they may be using restricted use pesticides. The importance of
such competency is amplified by the extensive areas involved, the quantities of pesticides needed, and
the ultimate use of many commodities as food and feed. Practical knowledge is required concerning soil
and water problems, pre-harvest intervals, re-entry intervals, phytotoxicity, and potential for
environmental contamination, non-target injury and community problems resulting from the use of
restricted use pesticides in agricultural areas.
• Agricultural pest control-Animal. Applicators applying pesticides directly to animals must demonstrate
practical knowledge of such animals and their associated pests. A practical knowledge is also required
concerning specific pesticide toxicity and residue potential, since host animals will frequently be used for
food. Further, the applicator must know the relative hazards associated with such factors as formulation,
application techniques, age of animals, stress, and extent of treatment.
• Forest pest control. Applicators shall demonstrate practical knowledge of types of forests, forest
nurseries, and seed production in their state and the pests involved. They should possess practical
knowledge of the cyclic occurrence of certain pests and specific population dynamics as a basis for
programming pesticide applications. A practical knowledge is required of the relative biotic agents and
their vulnerability to the pesticides to be applied. Because forest stands may be large and frequently
include natural aquatic habitats and harbor wildlife, the consequences of pesticide use may be difficult to
assess. The applicator must therefore demonstrate practical knowledge of control methods which will
minimize the possibility of secondary problems such is unintended effects on wildlife. Proper use of
specialized equipment must be demonstrated, especially as it may relate to meteorological factors and
adjacent land use.
• Ornamental and turf pest control. Applicators shall demonstrate practical knowledge of pesticide
problems associated with the production and maintenance of ornamental trees, shrubs, plantings, and turf,
including cognizance of potential phytotoxicity due to a wide variety of plant material, drift, and
persistence beyond the intended period of pest control. Because of the frequent proximity of human
habitations to application activities, applicators in this category must demonstrate practical knowledge of
application methods which will minimize or prevent hazards to humans, pets, and other domestic
animals.
• Seed-treatment. Applicators shall demonstrate practical knowledge of types of seeds that require
chemical protection against pests and factors such as seed coloration, carriers, and surface active agents
which influence pesticide binding and may affect germination. They must demonstrate practical
knowledge of hazards associated with handling, sorting and mixing, and misuse of treated seed such as
introduction of treated seed into food and feed channels, as well as proper disposal of unused treated
seeds.
• Aquatic pest control. Applicators shall demonstrate practical knowledge of the secondary effects which
can be caused by improper application rates, incorrect formulations, and faulty application of restricted
use pesticides used in this category. They shall demonstrate practical knowledge of various water use
situations and the potential of downstream effects. Further, they must have practical knowledge
concerning potential pesticide effects on plants, fish, birds, beneficial insects and other organisms which
may be present in aquatic environments. These applicators shall demonstrate practical knowledge of the
principles of limited area application.
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Right-of-way pest control. Applicators shall demonstrate practical knowledge of a wide variety of
environments, since rights-of-way can traverse many different terrains, including waterways. They shall
demonstrate practical knowledge of problems on runoff, drift, and excessive foliage destruction and
ability to recognize target organisms. They shall also demonstrate practical knowledge of the nature of
herbicides and the need for containment of these pesticides within the right-of-way area, and the impact
of their application activities in the adjacent areas and communities.
Industrial, institutional, structural and health related pest control. Applicators must demonstrate a
practical knowledge of a wide variety of pests, including their life cycles, types of formulations
appropriate for their control, and methods of application that avoid contamination of food, damage and
contamination of habitat, and exposure of people and pets. Since human exposure, including babies,
children, pregnant women, and elderly people, is frequently a potential problem, applicators must
demonstrate practical knowledge of the specific factors which may lead to a hazardous condition,
including continuous exposure in the various situations encountered in this category. Because health
related pest control may involve outdoor applications, applicators must also demonstrate practical
knowledge of environmental conditions, particularly related to this activity.
Public health pest control. Applicators shall demonstrate practical knowledge of vector-disease
transmission as it relates to and influences application programs. A wide variety of pests is involved, and
it is essential that they be known and recognized, and appropriate life cycles and habitats be understood
as a basis for control strategy. These applicators shall have practical knowledge of a great variety of
environments ranging from streams to those conditions found in buildings. They should also have
practical knowledge of the importance and employment of such non-chemical control methods as
sanitation, waste disposal, and drainage.
Regulatory pest control. Applicators shall demonstrate practical knowledge of regulated pests, applicable
laws relating to quarantine and other regulation of pests, and the potential impact on the environment of
restricted use pesticides used in suppression and eradication programs. They shall demonstrate
knowledge of factors influencing introduction, spread, and population dynamics of relevant pests. Their
knowledge shall extend beyond that required by their immediate duties, since their services are frequently
required in other areas of the country where emergency measures are invoked to control regulated pests
and where individual judgments must be made in new situations.
Demonstration and research pest control. Persons demonstrating the safe and effective use of pesticides
to other applicators and the public will be expected to meet comprehensive standards reflecting a broad
spectrum of pesticide uses. Many different pest problems situations will be encountered in the course of
activities associated with demonstration, and practical knowledge of problems, pests, and population
levels occurring in each demonstration situation is required. Further, they should demonstrate an
understanding of a pesticide-organism interactions and the importance of integrating pesticide use with
other control methods. In general, it would be expected that applicators doing demonstration pest control
work possess a practical knowledge of all of the standards detailed in 40 CFR 171.4(b). In addition, they
shall meet the specific standards required for 40 CFR 171.4(c)(l) through (7) as may be applicable to
their particular activity.
(NOTE: Persons conducting field research or method improvement work with restricted use pesticides
should be expected to know the general standards. In addition, they shall be expected to know the
specific standards required for the categories applicable to their particular activity, or alternatively, to
meet the more inclusive requirements listed under "Demonstration.")
This document is intended solely for guidance. No statutory or regulatory D2
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance
Audits under Pesticide Rules
Appendix E:
Entry Restricted Areas in Nurseries during Pesticide Applications
(40 CFR 170.110(b), Table 1)
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Entry Restricted Areas in Nurseries during Pesticide Applications
(40 CFR 170.110(b), Table 1)
A
During Application of a Pesticide:
Applied:
• aerially, or
• in an upward direction, or
• using a spray pressure greater than 150 psi.
Applied as a:
• fumigant, or
• smoke, or
• mist, or
• fog, or
• aerosol.
Applied downward using:
• a height of greater than 12 in from the
planting medium, or
• a fine spray, or
• a spray pressure greater than 40 psi and less
than 150 psi.
Not as above but for which a respiratory protection
device is required for application by the product
labeling.
Applied otherwise.
B
Workers are Prohibited In:
Treated area plus 100 feet in all directions on the nursery
Treated area plus 100 feet in all directions on the nursery
Treated area plus 25 feet in all directions on the nursery
Treated area plus 25 feet in all directions on the nursery
Treated area
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
El
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Protocol for Conducting Environmental Compliance Audits under FIFRA
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This document is intended solely for guidance. No statutory or regulatory £2
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental Compliance
Audits under Pesticide Rules
Appendix F:
Greenhouse Entry Restrictions Associated With Pesticide
Applications (40 CFR 170.110(c), Table 2)
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Protocol for Conducting Environmental Compliance Audits under FIFRA
Greenhouse Entry Restrictions Associated With Pesticide Applications
(40 CFR 170.110(c), Table 2)
A
When a Pesticide is
Applied:
(1) As afumigant
(2) As a smoke, mist, fog,
or aerosol
(3) Not in 1 or 2 above,
and for which a respiratory
protection device is
required for application by
the product labeling
(4) Not in 1,2, or 3 above,
and:
• from a height of greater
than 12 in. from the
planting medium, or
• as a fine spray, or
• using a spray pressure
greater than 40 psi
(5) Otherwise
B
Workers are Prohibited
in:
Entire greenhouse plus any
adjacent structure that
cannot be sealed off from
the treated area
Entire enclosed area
Entire enclosed area
Treated area plus 25 feet
in all directions in the
enclosed area
Treated area
C
Until:
The ventilation criteria of
40CFR170.110(c)(3)are
met
The ventilation criteria of
40CFR170.110(c)(3)are
met
The ventilation criteria of
40CFR170.110(c)(3)are
met
Application is complete
Application is complete
D
After the Expiration of
Time in Column C
Until the Restricted
Entry Interval Expires,
the Entry-Restricted
Area is:
No entry restrictions after
criteria in column C are
met
Entire enclosed area is the
treated area
Treated area
Treated area
Treated area
This document is intended solely for guidance. No statutory or regulatory
requirements are in any way altered by any statement(s) contained herein.
Fl
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Protocol for Conducting Environmental Compliance Audits under FIFRA
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This document is intended solely for guidance. No statutory or regulatory P2
requirements are in any way altered by any statement(s) contained herein.
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Protocol for Conducting Environmental
Audits under Pesticide Rules
Appendix G:
User Satisfaction Questionnaire and Comment Form
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User Satisfaction Survey
(OMB Approval No. 1860.01)
Expires 9/30/2001
We would like to know if this Audit Protocol provides you with useful information. This information will
be used by EPA to measure the success of this tool in providing compliance assistance and to determine
future applications and needs for regulatory checklists and auditing materials.
1. Please indicate which Protocol(s) this survey applies to:
Title:
EPA Document Number:
2. Overall, did you find the Protocol helpful for conducting audits:
Yes No
If not, what areas of the document are difficult to understand?
3. How would you rate the usefulness of the Protocol(s) for conducting compliance audits on a scale of 1-
5?
1 = not useful or effective, 3 = somewhat useful/effective, 5 = very useful/effective
Low Medium High
12345 Introduction Section
12345 Key Compliance Requirements
12345 Key Terms and Definitions
12345 Checklist
4. What actions do you intend to take as a result of using the protocol and/or conducting the audit? Please
check all that apply.
Contact a regulatory agency
Contact a compliance assistance provider (e.g., trade association, state agency, EPA)
Contact a vendor
Disclose violations discovered during the audit under EPA's audit Policy
Disclose violations discovered under EPA's Small Business Policy
Obtain a permit or certification
Change the handling of a waste, emission or pollutant
Change a process or practice
Purchase new process equipment
Install emission control equipment (e.g., scrubbers, wastewater treatment)
Install waste treatment system (control technique)
Implement or improve pollution prevention practices (e.g., source reduction, recycling)
Improve organizational auditing program
Institute an Environmental Management System
Improve the existing Environmental Management System (e.g., improve training, clarify standard
operating procedures, etc.)
Other
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5. What, if any, environmental improvements will result from the actions to be taken (check all that
apply)?
reduced emissions
waste reduction
reduced risk to human health and the environment due to better management practices
reduced quantity and toxicity of raw materials
water conservation
energy conservation
conserved raw materials
conservation of habitat or other environmental stewardship practice:
other:
no environmental improvements are likely to result from the use of this document
6. How did you hear about this document?
trade association
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EPA internet homepage or website
document catalog
co-worker or business associate
EPA, state, or local regulator
other (please specify)
7. In order to understand your response, we would like to know what function you perform with respect to
environmental compliance and the size of your organization.
Company Personnel Trade Association Compliance Assistance
Environmental Auditor National Provider
Corporate Level Regional EPA
Plant-level Local State
Legal Manager State Small Business
Environmental Manager Information Specialist Assistance
Operator - (e.g., Local
Pollution Control Other
Equipment
Other:
Regulatory Personnel Vendor/Consultant
State Environmental Auditor
Local Environmental
EPA Engineer/Scientist
Attorney
How many employees are located at your facility (including full-time contractors?)
0-9 10-49 50-100 101-500 More than 500
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Optional (Please Print)
Name: Address:
Title: City: State:_
Zip code:
Organization Name:
Phone: ( ) E-mail:
Please return all pages (1 thru 3) of this survey by folding pages 1 and 2 into page 3 and using the
preprinted, pre-stamped address on the reverse side of page 3. If you have accessed this document
electronically from one of EPA's web sites, simply e-mail this questionnaire to:
satterfield.richard(@,epa. gov.
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United States
Environmental Protection
Agency
Solid Waste and
Emergency Response
(5305W)
EPA530-K-02-018I
October 2001
»EPA
RCRA, Superfund & EPCRA
Call Center Training Module
Introduction to:
RCRA Financial Assurance
(40 CFR Parts 264/265, Subpart H)
Updated October 2001
-------
DISCLAIMER
This document was developed by Booz Allen Hamilton Inc. under contract 68-W-01-020 to EPA.
It is intended to be used as a training tool for Call Center specialists and does not represent a
statement of EPA policy.
The information in this document is not by any means a complete representation of EPA s
regulations or policies. This document is used only in the capacity of the Call Center training and
is not used as a reference tool on Call Center calls. The Call Center revises and updates this
document as regulatory program areas change.
The information in this document may not necessarily reflect the current position of the Agency.
This document is not intended and cannot be relied upon to create any rights, substantive or
procedural, enforceable by any party in litigation with the United States.
RCRA, Superfund & EPCRA Call Center Phone Numbers:
National toll-free (outside of DC area) (800) 424-9346
Local number (within DC area) (703) 412-9810
National toll-free for the hearing impaired (TDD) (800) 553-7672
The Call Center is open from 9 am to 5 pm Eastern Time,
Monday through Friday, except for federal holidays.
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RCRA FINANCIAL ASSURANCE
CONTENTS
1. Introduction 1
2. Regulatory Summary 2
2.1 Applicability 2
2.2 Closure/Post-Closure Care 3
2.3 Closure/Post-Closure Financial Assurance Mechanisms 4
2.4 Liability Requirements 9
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Financial Assurance - 1
1. INTRODUCTION
Owning and operating a hazardous waste treatment, storage, and disposal facility
(TSDF) is a costly venture that requires financial stability from the beginning of the
permitting process through the cessation of the post-closure period. Mainly, an
owner and operator must demonstrate that funds will be available to properly close
the facility and provide post-closure care. A TSDF owner and operator must also
have the financial resources to compensate third parties for any injury or accidents
that might result from facility operations. The requirements for such financial
assurance appear in Part 264/265, Subpart H.
In order to demonstrate that they have the financial resources to operate a
hazardous waste facility, an owner and operator must use one or more of a set of
financial assurance mechanisms designated by EPA. This training module addresses
the financial assurance standards, explaining first the allowable financial assurance
mechanisms and then the extent of financial coverage required. This module may
introduce some unfamiliar legal and financial concepts.
After completing this module, you will be able to explain the financial assurance
requirements for closure and post-closure care. Specifically, you will be able to:
• Identify the types of facilities subject to the financial assurance requirements
for closure and post-closure
• Calculate cost estimates
• Describe the allowable mechanisms for financial assurance, including which
mechanisms can be used together and under what conditions.
Additionally, you will be able to explain the financial assurance requirements for
accident liability coverage. Specifically, you will be able to:
• Discuss the applicability of sudden and nonsudden liability provisions
• Specify the amount of liability coverage required for single facilities and
multiple facilities
• List allowable mechanisms and combinations of mechanisms that can be used
to satisfy financial assurance liability requirements.
Use this list of objectives to check your knowledge of this topic after you complete
the training session.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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2 - Financial Assurance
2. REGULATORY SUMMARY
EPA established specific closure and post-closure care requirements to minimize
long-term environmental and health threats posed by hazardous waste TSDFs.
These requirements alone, however, do not guarantee that owners and operators of
TSDFs will have sufficient funds to properly close and maintain the site. EPA
promulgated the financial assurance requirements to ensure that owners and
operators could not default to federal funds because they were unable or unwilling
to cover significant closure and post-closure costs. Part 264/265, Subpart H, outlines
the mechanisms an owner and operator may use to prove that funds will be
available as well as the amounts that must be provided. Subpart H also establishes
minimum amounts of liability coverage for accidents during the active life of the
facility. Together, these requirements comprise the RCRA provisions known as
financial assurance.
2.1 APPLICABILITY
According to §§2647265.140(a), the requirements of Subpart H apply to owners and
operators of all hazardous waste TSDFs. The requirements of this subpart are not,
however, applicable to state and federally owned or operated facilities
(§§264/265.140(c)).
CLOSURE
All TSDFs, except those exempted in §§264/265.1, must fulfill certain closure
requirements. As specified in §§264/265.142 and 264/265.143, these TSDFs must
demonstrate financial assurance for closure. The closure requirements in Part
264/265, Subpart G, detail steps for safely and permanently ceasing operations at
active TSDFs. According to these requirements, owners and operators must submit
a closure plan that details the steps necessary to close or partially close the facility. In
addition to the general facility closure obligations of Subpart G, owners and
operators must also comply with closure and post-closure requirements for specific
hazardous waste management and disposal units (e.g., surface impoundments and
landfills) in Parts 264 and 265. Even those surface impoundments and waste piles
that the owner and operator intends to clean close by removing hazardous waste at
closure are required to have contingent closure plans (§§264.228(c)(l)(i) and
264.258(c)(l)(i)).
POST-CLOSURE
Post-closure care for inactive facilities entails long-term maintenance, monitoring,
and recordkeeping to ensure continuing protection of human health and the
environment after a TSDF has ceased operation. The financial requirements for
post-closure care in §§264/265.144 and 264/265.145 apply to all owners and operators
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Financial Assurance - 3
of disposal facilities as defined in §§264/265.140(b). Disposal facilities subject to these
requirements include not only landfills, but waste piles, surface impoundments,
and tanks that cannot be clean-closed, and therefore must be closed as landfills.
These units are then subject to full post-closure care. As part of the post-closure care
requirements, owners and operators must submit a post-closure plan that details the
operation and maintenance measures needed to ensure that no hazardous waste
will migrate off-site. Financial assurance for post-closure care is not required for
units that will be clean-closed (see §264.197 for tank systems, §264.228 for surface
impoundments, and §264.258 for waste piles). On the other hand, most owners and
operators will be required to prepare a contingent post-closure plan to ensure that
funds will be available to monitor any migration of waste left on-site in the
unforeseen event that a tank system, surface impoundment, or waste pile cannot be
clean-closed.
2.2 CLOSURE/POST-CLOSURE CARE
After an owner and operator completes the written closure and post-closure plans
for a facility, they must determine the implementation cost for both plans by
preparing cost estimates based on the cost of a third-party contractor performing
closure activities. These estimates provide the base figure for the amount of
financial assurance a facility will need to demonstrate.
COST ESTIMATES
According to §§264/265.142 and 264/265.144, cost estimates must reflect the cost of
hiring a third party to conduct all activities outlined in the closure and post-closure
plans. If a contingent closure or post-closure plan is required for a permitted surface
impoundment or waste pile, the cost of its implementation must be calculated into
the final cost estimate for the facility. Closure cost estimates are based on the point
in the facility's operating life when closure would be the most expensive. Post-
closure cost estimates are based on projected costs for a post-closure period of 30
years, which can only be reduced or extended by the Regional Administrator or state
director.
COST ADJUSTMENTS
Closure and post-closure cost estimates are adjusted annually for inflation until
closure is completed. Since a dollar this year is not worth as much as a dollar last
year, stating that a facility will cost one hundred dollars to close raises the question,
"which dollar should we use to make cost estimates?" There are two ways owners
and operators may address this issue. The more obvious and more cumbersome
method would be to recalculate the cost estimates completely each year. To save
time, however, a simpler method may be used. The Department of Commerce,
Bureau of Economic Analysis (BEA), publishes an official figure, called the Implicit
Price Deflator (IPD), which summarizes what a certain group of goods and services
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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4 - Financial Assurance
costs during that year. An owner and operator can then use the IPD to determine
how much prices "went up" (the inflation factor) and make a percentage adjustment
to the previous year's closure and post-closure cost estimates. For example, the 1998
IPD is 112.64 and the 1997 IPD is 111.52. By dividing the 1998 IPD by the 1997 IPD, the
inflation factor is determined, in this case 1.01. An owner and operator who
estimated closure/post-closure costs at $100 in 1995 dollars would multiply $100 by
the inflation factor of 1.01 to find an updated estimate of $101 in 1998 dollars. (Note
that some states require the use of the most current quarterly IPD to calculate the
inflation factor while others require use of the annual figure. In addition, all IPD
values are subject to change by the BEA.)
This calculation is illustrated by the following equations:
IPD current year . „ .
= inrlationractor
IPD previous year
(inflation factor) x (old estimate) = new estimate
Inserting the figures given:
112.64/111.52 = 1.01 = inflation factor
(1.01) x ($100) = $101 = new cost estimate
Historically, the Department of Commerce emphasized the use of the IPD derived
from the Gross National Product (GNP), but since December 1991 the Department of
Commerce has focused on the use of the Gross Domestic Product (GDP) to derive
the IPD. There is only a slight difference between the numbers, and owners and
operators may use either to derive the IPD as long as they are consistent in their use
of GNP or GDP. If an owner or operator switches from using GNP to GDP, then
previous cost estimates must be adjusted accordingly.
Owners and operators must adjust cost estimates following any changes to their
closure or post-closure plan that would raise the costs involved. For example,
expansion of a surface impoundment might increase the amount of contaminated
soil to be removed at closure. The closure and post-closure estimates must be
recalculated to reflect the additional expenses.
2.3 CLOSURE/POST-CLOSURE FINANCIAL ASSURANCE
MECHANISMS
An owner and operator must use one or more of the specified financial assurance
mechanisms to demonstrate that funds are available to pay for closure and post-
closure care of a facility.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Financial Assurance - 5
MECHANISMS
An owner and operator may demonstrate financial assurance for closure and post-
closure by choosing from the following financial assurance mechanisms:
• Trust Fund • Letter of Credit
• Surety Bonds (two types) • Insurance
Payment Bonds • Financial Test
Performance Bonds • Corporate Guarantee.
The wording of each mechanism, or instrument, must be identical to the examples
in §264.151. The criteria for using each of these mechanisms are discussed below.
Trust Fund
A trust fund serves as a way to set aside monies specifically earmarked for closure
and post-closure costs. Owners and operators pay money into the trust fund during
a specified period. By the time a facility closes, the money accumulated in the fund
should be adequate to cover the necessary closure costs. The pay-in period for
interim status facilities is 20 years from the effective date of the regulations (July 6,
1982), or the remaining operating life of the facility, whichever period is shorter.
For permitted facilities, the owner and operator must make payments into the trust
fund for the term of the initial permit or the remaining operating life of the entire
facility (as estimated in the closure plan), whichever period is shorter.
The annual payment for the duration of the pay-in period may be calculated using
the following equation, where the annual payment (AP) equals the current cost
estimate (CE) minus the current value of the trust fund (CV) divided by the number
of years remaining in the pay-in period (Y):
AP = (CE - CV)/Y
Surety Bonds
A surety bond is a guarantee by a surety company that certain specified obligations
will be fulfilled. If the owner and operator fail to pay the closure or post-closure
costs specified in a bond, the surety company is liable for the costs. The owner and
operator must also establish a standby trust fund into which any payments made by
the surety company will be deposited. EPA then uses the trust fund to cover closure
costs. There are two types of surety bonds:
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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6 - Financial Assurance
Payment Bond
A payment bond will, in the event an owner and operator fails to pay, fund a
standby trust fund in an amount equal to the value (penal sum) of the bond.
Performance Bond
A performance bond guarantees that the owner and operator will perform the
final closure in accordance with the requirements of the facility's permit.
Performance bonds may be paid into a standby trust fund. Interim status
facilities can not use performance bonds.
Surety bonds only pay when the owner and operator fails to either pay for or
perform closure and post-closure activities. An owner and operator is generally
obligated to repay the surety company.
Letter of Credit
To use a letter of credit assuring financial coverage for closure and post-closure care,
the facility owner and operator must satisfy the following requirements:
• The owner and operator must obtain a letter of credit that is irrevocable
and equals the amount of the cost estimate
• The owner and operator must increase the letter of credit within 60 days
whenever the current cost estimate increases
• The owner and operator must establish a standby trust fund into which
any payments made by the issuing institution will be deposited
• If the owner and operator fails to fulfill closure or post-closure
requirements, the Regional Administrator is entitled to direct the issuing
institution to deposit funds into the owner and operator's standby trust
fund.
Insurance
In order for the owner and operator of a facility to use insurance as the financial
mechanism covering the cost of closure and post-closure care, the following
requirements must be satisfied:
• The owner and operator must obtain an insurance policy for a face
amount (the total money the insurer is obligated to pay under the policy)
at least equal to the cost estimate for closure or post-closure care
• The owner and operator must increase the face amount or obtain other
supplementary financial assurance if the cost estimate increases
• The policy must allow its assignment to a successor owner and operator
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Financial Assurance - 7
• The owner and operator must send a copy of the policy to the head of the
hazardous waste program in the state, if the state is authorized to
administer the RCRA base program. In unauthorized states, a copy is sent
to the Regional Administrator
• If the owner and operator fails to pay the premium, the insurer may
cancel, terminate, or decide not to renew the policy
• The insurer must be licensed by a state, as off-shore insurers are not
acceptable.
Financial Test
The owner and operator may satisfy the requirements for financial assurance by
meeting the financial test criteria for either of the following alternatives.
Alternative I
• The owner and operator must meet each of the following criteria:
Net working capital equals 6 times current closure, post-closure,
plugging, and abandonment cost estimates
Tangible net worth is greater than $10 million
Ninety percent of total assets are located in the United States, or at least
6 times the current closure, post-closure, and plugging and
abandonment cost estimates
and
• The owner and operator must satisfy two of the following three ratios:
Liabilities to net worth ratio less than 2
Current assets to current liabilities ratio greater than 1.5
Net income (plus depreciation, depletion, and amortization) to
liabilities ratio greater than 0.1.
Alternative II
• The owner and operator must meet each of the following criteria:
- Tangible net worth at least 6 times current closure, post-closure,
plugging, and abandonment cost estimates
- Tangible net worth is greater than $10 million
Ninety percent of total assets are located in the United States, or at least
6 times the current closure, post-closure, and plugging and
abandonment cost estimates
- The current bond rating for the most recent bond issuance is AAA, AA,
A, or BBB as issued by Standard & Poor's, or Aaa, Aa, A, or Baa as
issued by Moody's.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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8 - Financial Assurance
The owner and operator must pass one of the two financial tests specified in the
closure and post-closure financial assurance requirements. If the owner and
operator chooses to use a financial test to meet financial assurance requirements,
this must be documented in a letter to the Regional Administrator, signed by the
company's Chief Financial Officer, and attached to an independent Certified Public
Accountant report examining the owner and operator's annual report.
Corporate Guarantee
In order for the owner and operator of a facility to use a corporate guarantee to
ensure financial coverage for closure and post-closure care, the following
requirements must be satisfied:
• The guarantor must be a direct corporate parent (a corporation that directly
owns at least 50 percent of the voting stock of another corporation or
subsidiary), a corporate grandparent (a corporation that indirectly owns
over 50 percent of a company through a subsidiary), a sibling corporation
(a corporation that shares the same parent corporation), or a firm with a
substantial business relationship with the owner and operator
• The guarantor must meet the financial test requirements outlined above
• The guarantor must perform the required closure and post-closure care
activities or establish a trust fund to pay a third party to perform them if
the owner and operator fails to carry out final closure or post-closure care
in accordance with the approved plan.
COMBINATIONS
An owner and operator may combine certain financial assurance mechanisms to
cover the cost of closure and post-closure care for a facility. For example, an owner
and operator can combine trust funds, payment surety bonds, insurance policies,
and letters of credit may be combined to meet financial assurance requirements.
Performance surety bonds, financial tests, and corporate guarantees cannot be used
in combination to demonstrate assurance.
An owner and operator may also use a single financial assurance mechanism to
meet the cost of closure and post-closure care for more than one facility. The dollar
amount of the funds available through the mechanism must be no less than the
sum of funds that would be available if a separate assurance mechanism had been
established and maintained for each facility (§§264.143(h), 265.143(g), 264.145(h), and
265.145(g)).
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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Financial Assurance - 9
PERIOD OF COVERAGE
Within 60 days after an acceptable certification of final closure is received, the
Regional Administrator notifies the owner and operator that financial assurance for
final closure is no longer required. Within 60 days of receipt of acceptable
certification that the post-closure care period has been completed, the Regional
Administrator notifies the owner and operator that financial assurance for post-
closure care is no longer required (§§264.143(1), 265.143(h), 264.145(1), and 265.145(h)).
2.4 LIABILITY REQUIREMENTS
The owner and operator are required to maintain accident liability coverage until
certification of final closure (§§264/265.147). This coverage ensures that, should an
accident resulting in a release of hazardous constituents occur, money will be
available to compensate third parties suffering bodily injury or property damage
resulting from the accident. Under §§264/265.147(c), an owner and operator may
receive a variance from the Regional Administrator if the owner and operator can
demonstrate that the levels of financial responsibility required by the regulations are
not consistent with the levels of risk associated with the facility's operation. For
permitted facilities, this would appear as a permit modification. Variances,
however, are seldom granted. Liability coverage is not required for state or federally
owned or operated facilities.
TSDFs may be required to demonstrate liability coverage for both sudden and
nonsudden accidental occurrences. The applicability of sudden and nonsudden
coverage and the differences between them are explained below. The owner and
operator may use a combination of mechanisms as long as the amount covered
equals the total of sudden and nonsudden liability minimum requirements.
SUDDEN ACCIDENTAL OCCURRENCES
A sudden accidental occurrence is an event that is not continuous or repeated.
Examples of sudden accidental occurrences are fires and explosions. All TSDFs that
are subject to financial assurance requirements must have coverage for sudden
accidental occurrences (§§264/265.147(a)).
The owner and operator must meet the minimum financial requirements for
liability coverage of sudden accidental occurrences by using one or more of the
following allowable mechanisms specified in §§264/265.147(a)(6): insurance,
financial test, corporate guarantee, letter of credit, surety bond, and trust fund. The
minimum financial requirements include at least $1 million per occurrence and an
annual aggregate of at least $2 million. While a per occurrence amount limits the
payment for any one event, such as a fire, an annual aggregate caps the total dollar
value of all claims in one year. These funds will suffice to cover all of the owner
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
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10 - Financial Assurance
and operator's facilities. Table 1 demonstrates such a disbursement of sudden
liability funds over a one-year period.
Table 1
DISBURSEMENT OF SUDDEN LIABILITY FUNDS
Number of Accidents
1
3
6
Cost per Accident
$3 million
$1 million
$500,000
Amount Paid by Liability
Coverage
$1 million
first $2 million
$500,000 on first four
NONSUDDEN ACCIDENTAL OCCURRENCES
A nonsudden accidental occurrence is an event that takes place over time and
involves continuous or repeated exposure to hazardous waste. An example of a
nonsudden accidental occurrence is a leaking surface impoundment that
contaminates a drinking water source over time. The owner and operator of a
surface impoundment, landfill, land treatment facility, or miscellaneous disposal
unit must have financial assurance for nonsudden accidental occurrences
(§§264/265.147(b)).
The owner and operator must meet the minimum financial requirements for
liability coverage of nonsudden accidental occurrences by using one or more of the
following allowable mechanisms specified in §§264/265.147(a)(6): insurance,
financial test, corporate guarantee, letter of credit, surety bond, or trust fund. The
minimum financial requirements include at least $3 million per occurrence and an
annual aggregate of at least $6 million. These funds will satisfy the requirements for
all of the owner or operator's facilities.
Note that these liability minimums apply regardless of the number of facilities held
by an owner and operator. Therefore, someone owning multiple facilities only
needs one set of coverage for $3 million/$6 million. Table 2 demonstrates such a
disbursement of nonsudden liability funds over a one-year period.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
-------
Financial Assurance - 11
Table 2
DISBURSEMENT OF NONSUDDEN LIABILITY FUNDS
Number of Accidents
1
3
6
Cost per Accident
$4 million
$4 million
$2 million
Amount Paid by Liability
Coverage
$3 million
$3 million on first
$3 million on second
$2 million on first three
COMBINATION OF LIABILITY COVERAGE LEVELS
Owners and operators who combine coverage levels for sudden and nonsudden
accidental occurrences must maintain liability coverage in the amount of at least $4
million per occurrence ($1 million sudden plus $3 million nonsudden) and $8
million annual aggregate ($2 million sudden plus $6 million nonsudden)
(§§264/265.147(b)).
PERIOD OF COVERAGE
Within 60 days after an acceptable certification of final closure is received, the
Regional Administrator will notify the owner and operator that liability coverage is
no longer required (§§264/265.147(e)). Since final closure occurs before a facility
begins post-closure activities, liability coverage is not required during the post-
closure period. The Regional Administrator, however, may require liability
coverage if closure was not completed in accordance with the facility's closure plan.
The information in this document is not by any means a complete representation of EPA's regulations or policies,
but is an introduction to the topic used for Call Center training purposes.
-------
IDENTIFICATION AND
MANAGEMENT OF
REGULATED HAZARDOUS
WASTE
A Workshop Geared Towards
Healthcare Facilities
March 2004
U.S. EPA Region 2
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IDENTIFICATION AND
MANAGEMENT OF
REGULATED HAZARDOUS
WASTE
A Workshop Geared Towards
Healthcare Facilities
March 2004
EPA Region 2
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Agenda-1
Hazardous Waste & Healthcare
• Healthcare facilities manage many types of waste
- Normal solid waste (paper waste)
- Medical/infectious waste (red bag)
- Hazardous waste
- Radioactive Waste
• These wastes are also regulated by state and local
regulations
EPA Region 2
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Agenda-2
Hazardous Waste & Healthcare (Cont'd)
• These wastes are regulated by many federal regulations,
such as
-CAA - CERCLA
- CWA (including oil pollution prevention and storm water)
-DBA - FDA
-EPCRA - FIFRA
-NRC - OSHA
-RCRA - SDWA
-TSCA
• Today's presentation identifies federal hazardous waste
requirements under RCRA
EPA Region 2
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Agenda-3
Hazardous Waste & Healthcare (Cont'd)
• Healthcare issues covered today
- Lab/Storage clean-ups and impact on generator status
- Satellite accumulation areas
- Facility definition and transport between facilities
- Hospital-specific waste issues
i Chemotherapy agents
i Expired pharmaceuticals
i ER use (such as epinephrine and nicotine patches)
i Mercury laboratory wastes
i P- and U-type RCRA-listed wastes
I ETO explosion risk
I Picric acid
EPA Region 2
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Agenda-4
Course Overview
Exhibits
• Discarded Material - Exhibit I
• Solid Waste Exclusions - Exhibit II
• Hazardous Waste Exclusions - Exhibit III
• Listed Hazardous Waste - Exhibit IV
• Delisted Wastes - Exhibit V
• "Mixture" and "Derived - From" Rules - Exhibit VI
EPA Region 2
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Agenda-5
Course Overview (Cont'd)
Exhibits
• Hazardous Waste Characteristics - Exhibit VII
• Recycled Materials - Exhibit VIII
• Universal Waste Rule - Exhibit IX
• Generator Requirements - Exhibit X
• Special Management Practices - Exhibit XI
- Tanks
- Containers
EPA Region 2
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Agenda-6
Course Overview (Cont'd)
• Authority
- RCRA Statute
- RCRA Regulations - 40 CFR
- Federal Register Preambles
- Policy Memos and Guidance
EPA Region 2
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Agenda-7
Course Overview (Cont'd)
General comments
- Designed for hazardous waste identification in general,
with hospital examples and pollution prevention tips
added
- Hospital-specific material denoted by
- Designed to follow federal not state regulations
EPA Region 2
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Agenda-8
Course Overview (Cont'd)
• Miscellaneous issues
- Course is designed to be interactive
i Questions
i Examples
i Case studies
- Promptness - keep on time
- Course evaluations
EPA Region 2
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Introduction
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Intro
Introduction
EPA Region 2 10
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Intro-1
For hospitals, it is most important to know your
generator status because permit requirements depend
on which type you are:
Large Quantity Generator (LQG)
Small Quantity Generator (SQG)
• Conditionally-Exempt Small Quantity Generator (CESQG)
Your status depends on how much waste you
generate.
•The first step in any regulatory process is to determine what is regulated. In the case of RCRA, defining the universe of regulated wastes is the first
requirement. All other regulations flow from this definition. That is, activities, units, and people regulated under RCRA, depends upon whether
hazardous wastes are being managed.
EPA Region 2
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Intro-2
Common Hospital Region 2 Hazardous
Waste Violations/Issues
• Labeling of hazardous waste (H W) not done or incorrect
Not conducting proper weekly inspections of HW storage
Improper disposal of chemotherapy drugs
HW determinations not done or incorrect
No or inadequate HW manifests
Throwing HW down the drain
Improper management of expired pharmaceuticals,
paints, etc.
(continued on next slide)
EPA Region 2 12
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Intro-3
Common Hospital Region 2 Hazardous
Waste Violations/Issues, continued
• Lack of contingency plan
Lack of or inadequate training for employees in HW
management
Failure to ensure that HW meets Land Disposal Restriction
Failure to upgrade or close underground storage tanks
(USTs) by 12/22/1998
Improper consolidation of wastes from nearby facilities
EPA Region 2 13
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Intro-4
Common Errors Made in Waste
Identification ^^^^
• Waste generation process not described ^f ^^F\
. 1 ft. + 1 -1 meter
Test methods not identified
• Sampling methods not specified ^^^^^^^^^r
• Field and laboratory QA/QC not identified
• Proper conversion factors not used
• Representative sample not obtained
•We'll learn that wastes may be listed by their sources. Are the sources adequately described?
•Have the correct test methods been used? SW-846 provides the exact methods to be used by EPA, states and the regulated community.
•Similarly, EPA's Laboratory Method for Solid Waste (SW-846) describes the appropriate sampling methods to assure representativeness of the sample.
•Quality control/quality assurance is imperative. The laboratory testing the waste must maintain QA/QC to assure they properly analyze wastes.
Similarly, field sampling can easily be contaminated by poor handling procedures.
•Finally, a VERY common mistake is the improper conversion of ug/1 to ppm. The order of magnitude difference can result in a misidentification of a
waste which SHOULD be regulated. 1,000 ug/L = 1 ppm; whereas 1 mg/L = 1 ppm.
EPA Region 2 14
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Intro-5
Common Errors Made in Waste
Identification (Cont'd) ^^p^^^
• Failure to reevaluate after process f ,^r\
1 ft. + 1 1 meter
change
• Failure to properly evaluate newly ^^^^^^^^P
generated wastes
• Failure to evaluate all waste streams
• Failure to take advantage of variances, exemptions,
or policies that could result in reduced regulatory
requirements
EPA Region 2 15
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Intro-6
Decision Diagrams
• A - Defining Regulated Waste
• B - Recycling
• C - Small Quantity Generators
•The most important tool you will get through this course is the set of three decision diagrams.
•These were designed to help you walk through the regulations to ensure you identify all of the regulations which may apply.
•They are extremely useful, regardless of your experience in the program.
•Each section of the course relates back to the three diagrams.
•Decision Diagrams B and C are, in fact, detailed elements of Decision Diagram A.
EPA Region 2 16
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Intro-7
Diagram A
EPA Region 2 17
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Decision Diagram A: Determination of Subtitle C
Regulation Status of a Waste
Decision Flow Chart
Intro-
40 CFR Reference
Is the material a discarded
material? (See Decision
Diagram B)
Yes
Not a solid waste
261.2
(1)
Is the material excluded
under §261.4(a)?
No
Yes
Not a solid waste
J261.
4(a)
(2)
Is the material excluded by
a variance granted under
§§ 260.30 & 260.31?
No
Yes
Not a solid waste
/260.30
\260.31
(3)
The material is a
solid waste (1)
(4)
(Continued)
(1) For materials that are recycled, see Decision Diagram B.
EPA Region 2
18
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Decision Diagram A: Determination of Subtitle C
Regulation Status of a Waste (Cont'd)
Decision Flow Chart
Intro-9
40 CFR Reference
(Continued)
1
Is the solid waste excluded
from consideration as a
hazardous waste under
§261.4(b)?
No
Yes
Not a hazardous waste
(still subject to Subtitle
D Control)
261.4(b)
(5)
Yes
Is the solid waste listed as a
hazardous waste (K, P, or U)?
No
<261, SubpartD
(6)
Is the solid waste derived from
the treatment, storage, or
disposal of a listed hazardous
waste?
Yes
No
No
Is the solid waste pickle liquor
sludge or waste from burning
petroleum-based wastes?
Yes
(261.3(c)(2)
\261.6(a)(3)(v)-(ix)
(7)
(Continued)
(Continued) (Continued)
EPA Region 2
19
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Decision Diagram A: Determination of Subtitle C
Regulation Status of a Waste (Cont'd)
Decision Flow Chart
Intro-10
40 CFR Reference
(Continued)
(Continued)
(Continued)
Yes
Yes
Is the solid waste a mixture of
a solid waste and a hazardous
waste listed solely because it
exhibits a characteristic?
Does the mixture continue to
exhibit the characteristic? (2)
No
The mixture is not a hazardous
waste (still subject to Subtitle
D control)
Yes
Is the solid waste a
mixture of a solid
waste and a listed
hazardous waste?
Does the mixture consist of
wastewater the discharge of
which is regulated under
CWA (Section 402 or 307(b))
and certain hazardous wastes
identified in §261.3(a)(2)(iv)?
Yes
No
Is the solid waste
environmental media
which contains listed
hazardous waste?
261.3(d)(2)
Yes
X"
(26 L
.3(a)(2)(iv)
(8)
Has the waste been delisted?
No
Yes
The solid waste is not a
hazardous waste (still subject to
Subtitle D control and any
applicable delisting conditions)
(9)
(10)
Does the waste exhibit a characteristic? (3)
Yes
No
/26L
Subpart C
The waste is a hazardous waste
T
(Continued)
(2) For any mixture containing Bevill wastes see §261.3(a)(2)(iii).
(3) For any mixture containing Bevill wastes see §261.3(a)(2)(ii).
EPA Region 2
20
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Decision Diagram A: Determination of Subtitle C
Regulation Status of Waste
Decision Flow Chart
Intro-11
40 CFR Reference
(Continued)
Is the hazardous waste recycled?
(See Decision Diagram B)
Npl
Yes
The recyclable material may be
determined not to be solid waste or
regulated under Part 266 or subject to the
foil set of Subtitle C regulations
f261.1(c)
J 261.2(c),(d),(e)
) 261.6
VPart 266
(11)
Is the hazardous waste generated by a
small quantity generator?
(See Decision Diagram C)
No
Yes
The hazardous waste may be subject
to limited regulation under §261.5
or Part 262.
/261.5
(Part 262
(12)
Does the hazardous waste occur under any
of the following Special Management
Practices? Are the materials...
- wastes that are generated and remain in a
product or raw material storage tank, transport
vehicle, or manufacturing process unit?
Yes
Has the storage tank or unit ceased
to operate and remained out of
operation for more than 90 days?
- samples collected for the sole purpose of
determining characteristics or composition which
are managed as required in Section 261.4(d)
while stored or transported?
No
Yes
Yes
Not subject to
Subtitle C regulations
- samples collected for the sole purpose of
conducting treatability studies which are
managed as required under Section 261.4(e) while
stored or transported?
Yes
Yes
- samples undergoing treatability studies which
are managed as required under Section 261.4(f)?
Yes
- residues remaining in an empty container are
managed as required under Section 261.7(a)(i)?
- PCB-containing dielectric fluid or
electric equipment containing such fluid
regulated under TSCA (part 761) and fail the TC
(D018-D043 only)?
No
Yes
The waste is a regulated hazardous waste and is subject to the full
set of RCRA Subtitle C requirements including land disposal
restrictions under Part 268
/261.4(c)
/261.4(d)
J261.4(e)
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Intro-12
Diagram B
EPA Region 2 22
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Decision Diagram B: Determination of When a Hazardous Waste that
is Recycled is Subject to Subtitle C Regulation
Intro-13
Decision Flow Chart
40 CFR Reference
Is the material excluded
under 261.6(a)(3)?
No
Yes
Material is not subject to
regulation
-------
Decision Diagram B: Determination of When a Hazardous Waste that
is Recycled is Subject to Subtitle C Regulation (Cont'd)
Intro-14
Decision Flow Chart
40 CFR Reference
(Continued)
Is the material burned for
energy recovery in a boiler
or industrial furnace that is
not regulated under
Subpart O of Part 264 or
265 or is the material used
to produce a fuel or
contained in a fuel, unless
this is its normal use?
No
Yes
(Continued)
Is the material used oil that
exhibits one or more of the
characteristics of hazardous
waste?
Is the material a commercial
chemical product that is listed
in §261.33 and produced to be
burned as a fuel?
Yes
Subject to regulation under
Part 266 Subpart E
Yes
Material is not a
solid waste
266 Subpart D
266 Subpart E
261.2(c)(2)(i)(B)
Material is subject to
regulation under Part 266
Subpart D
EPA Region 2
24
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Decision Diagram B: Determination of When a Hazardous Waste that
is Recycled is Subject to Subtitle C Regulation (Cont'd)
Intro-15
Decision Flow Chart
40 CFR Reference
(Continued)
No
Is the material used or reused as
an ingredient in an industrial
process, or as an effective
substitute for a commercial
product, without being reclaimed?
No
Yes
Material is not a solid waste
261.2(e)
(5)
Is the material
recycled by being
returned to the
original process
from which it was
generated?
No
Yes
(Continued)
Is the material
reclaimed prior to
return to original
process?
Yes
Is the reclamation process
in closed-loop tanks and
are requirements of
§261.4(a)(8)met?
Yes
Is the material returned as a substitute
for raw material feedstock and does
the process use raw material as
principle feedstocks?
Yes
Is the material
excluded by a
variance granted
under §260.30(b)?
Yes
Material is not a
solid waste
261.2(c)(3)
261.2(e)(l)(
261.4(a)(8)
EPA Region 2
25
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Decision Diagram B: Determination of When a Hazardous Waste that
is Recycled is Subject to Subtitle C Regulation (Cont'd)
Intro-16
Decision Flow Chart
40 CFR Reference
(Continued)
Is the material reclaimed?
No
Yes
Material is not recycled.
Return to Diagram A.
Is the material excluded by a
variance granted under
§260.30(c)?
Is the material a characteristic
by-product or sludge, or a
commercial chemical product
listed under §261.33?
Are precious metals reclaimed
from the material?
Is the material spent lead-acid
batteries?
Material is subject to full
Subtitle C regulation
Yes
Yes
Subject to regulation under
Part 266, Subpart F
260.30(c)
261.2(c)(3)
I261.6(a)(2)(iv)
261.6(a)(2)(v)
Subject to regulation under
Part 266, Subpart G
EPA Region 2
26
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Intro-17
Diagram C
EPA Region 2 27
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Decision Diagram C: Determination of Small Quantity Generator Status
Decision Flow Chart
Intro-18
40 CFR Reference
Is the facility a potential
small quantity generator?
Yes
^
Is the hazardous waste
generated subject to
Subtitle C regulations?*
Yes
T
r
Is the hazardous waste
subject to substantive
requirements of Subtitle C?
Yesl
Subject to full Subtitle C
regulation.
The waste is not included in
quantity determination.
The waste is not included in
quantity determination.
J261.5(a)
J261.5(c)*
<261.5(c)
(1)
(Continued)
Notes:
*Under 40 CFR 261.5(c), you can except hazardous waste that: (1) Is exempt from regulation under 40 CFR 261.4(c) through (f),
261.6(a)(3), 261.7(a)(l), or 261.8; or (2) Is managed immediately upon generation only in on-site elementary neutralization units,
wastewater treatment units, or totally enclosed treatment facilities as defined in 40 CFR 260.10; or (3) Is recycled, without prior
storage or accumulation, only in an on-site process subject to regulation under 40 CFR 261.6(c)(2); or (4) Is used oil managed under
the requirements of 40 CFR 261.6(a)(4) and 40 CFR part 279; or (5) Is spent lead-acid batteries managed under the requirements of
40 CFR part 266, subpart G; or (6) Is universal waste managed under 40 CFR 261.9 and 40 CFR part 273.
EPA Region 2
28
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Decision Diagram C: Determination of Small Quantity Generator Status (Cont'd)
Intro-19
Decision Flow Chart
40 CFR Reference
(Continued)
Is the hazardous waste:
- removed from on-site storage and has
been previously included in quantity
determination;
or
- produced by on-site treatment
(including reclamation) of waste already
included in quantity determination;
or
- spent materials generated, reclaimed and
subsequently reused on-site that have
already been included in quantity
determination?
No
Yes
The waste is not included in
quantity determination.
261.5(d)
(2)
No
Is the waste an acutely hazardous waste?
Yes
Is the acute hazardous waste generated at
quantities greater than:
- 1 kg of acute hazardous waste per
calendar month; or
- 100 kg per calendar month of any
residue or contaminated soil, waste or
other debris resulting from clean-up of
a spill of any acute hazardous waste?
Yes
Subject to Subtitle C
regulation.
,261.5(e)
No
(Continued)
(Continued)
EPA Region 2
29
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Decision Diagram C: Determination of Small Quantity Generator Status (Cont'd)
Decision Flow Chart
Intro-20
40 CFR Reference
(Continued)
No
(Continued)
No
Does generator comply with
requirements set forth in §261.5(f)?
Yes
Subject to Subtitle C
regulation
261.5(f)
The waste is conditionally exempt
(3)
Is the sum of wastes
included in the quantity
determination less than 100
kg of non acute hazardous
waste per calendar month?
Yes
Does the sum of the
wastes equal between
100 kg and 1000 kg
per calendar month?
Yes
The waste may be
subject to special
requirements under
Part 262.
,261.5(a)
Subject to full
Subtitle C regulation.
(4)
Does generator at any time
accumulate more than 1,000
kg of hazardous waste?
Yes
No
All of the accumulated wastes are
subject to modified Part 262
regulations at the time accumulation
first exceeds 1,000 kg.
/261.5(g)(2)
\262.34(d)
(Continued)
EPA Region 2
30
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Decision Diagram C: Determination of Small Quantity Generator Status (Cont'd)
Decision Flow Chart
Intro-21
40 CFR Reference
(Continued)
I
Is the hazardous waste mixed
with solid waste and the
resultant mixture exceeds the
quantity limitations?
No
Does the mixture
exhibit a
characteristic?
Yes
Subject to full
Subtitle C
regulation
261.5(h)
The waste is
conditionally
exempt
(5)
Is the waste mixed with
used oil and is the resultant
mixture to be used for
energy recovery?
No
Yes
The mixture, in addition to any material
produced from such a mixture by
processing, blending, or other treatment
if also destined for energy recovery, is
subject to regulation under Subpart E of
Part 266
Subpart D
Subpart E
(6)
Does generator comply with
requirements set forth in
§261.5(g)?
Yes
Subject to full
Subtitle C regulation
S261.
5(g)
(7)
The generator is a
conditionally exempt small
quantity generator during the
measured calendar month
EPA Region 2
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Discarded
Material
-------
Exhibit I
Discarded Material
Overheads from Presentations
RCRA Policy Excerpts
EPA Region 2 32
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Exhibit 1-1
Statutory Definition
RCRA §1004 (27) 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.
•A common mistake is to forget that RCRA defines solid and hazardous waste. It is particularly important to understand the statutory definition of solid
waste. Under RCRA, a solid waste can be a liquid or a gas.
EPA Region 2 33
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Discarded Material
A material is a solid waste if it is discarded
Exhibit 1-2
261.2(a)(l)
•The regulations begin in a deceptively easy manner.
EPA Region 2 34
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Exhibit 1-2
Discarded Material
• Abandoned
• Recycled
• Inherently waste-like
261.2(a)(2)
•Very straight-forward definition in the regulations.
•Definitions to follow.
EPA Region 2 35
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Exhibit 1-4
Abandoned
• Disposed of
• Burned or incinerated
• Accumulated, stored, or treated before, or instead of, being
disposed, burned, or incinerated
261.2(b)
•Again, very straight forward definition.
•Basic approach is if you intend to get rid of it, it is abandoned.
EPA Region 2 36
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Exhibit 1-5
Abandoned
• 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 give it to someone else that has a use for it?
261.2(b)
•Again, very straight forward definition.
•Basic approach is if you intend to get rid of it, it is abandoned.
EPA Region 2 37
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Exhibit 1-6
Recycled
Specific types of recycled materials are
considered discarded
- Used in a manner constituting disposal
- Burned for energy recovery
- Reclaimed
- Accumulated speculatively
A material is also considered discarded if it is
accumulated, stored or treated before recycling
261.2(c)
•We'll go into more detail when we discuss recycling later.
•Used in manner constituting disposal - placed on the land, such as road oiling, dust suppression if material was not produced to be placed on the land.
•Burned for energy recovery - burned to gain energy, such as steam, from wastes with high Btu values.
•Reclaimed - processed to recover a usable product.
•Speculative accumulation. If less than 75% of a waste is recycled in a calendar year, it is being speculatively accumulated.
EPA Region 2
38
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Exhibit 1-7
Inherently Waste-Like 261.2(d)
• Certain wastes are considered hazardous even when recycled
• These are materials that pose a threat to human health and the
environment when recycled
• So far, only dioxin containing wastes have been designated as
inherently waste-like
- F020, F022, F023, F026, F028
F021, unless it is used at the site of generation
261.2(d)
•These are wastes that have no potential for further use.
•Ones now listed are dioxin-containing wastes.
•The Administrator will list additional wastes for cause based on the following criteria:
- Materials are ordinarily disposed of, burned or incinerated.
- Materials contain Appendix VIII constituents not ordinarily found in raw materials - or products for which the materials substitute - and are not used or
reused during recycling.
- Materials may pose a substantial hazard to human health and the environment when recycled.
•No other wastes have been proposed.
•Secondary materials added February 21, 1991 FR.
EPA Region 2 39
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Exhibit 1-8
Appropriate Documentation
Must Be Provided
• Respondents who claim that a certain material is not a solid waste, or is
conditionally exempt from regulation, must demonstrate a known
market or disposition and that terms of exclusion or exemption are met
• In plain English, that means you need:
Documentation (such as contracts) showing that a second person
uses the material as an ingredient in a production process
If recycling, must show that they have the necessary equipment
Don't buy more than you need.
261.2(f)
•The regulated community holds the burden to demonstrate that his or her material does not meet the criteria to be considered a solid waste. This includes
test results, equipment and other documentation supporting his or her claim.
EPA Region 2 40
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Exhibit 1-9
Relevant Federal Regulations
40 CFR Part 261
SubpartA 261.1(c)
261.2
EPA Region 2 41
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Pag
Faxback 11958
9451.1996(07)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF
SOLID WASTE AND EMERGENCY RESPONSE
July 12. 1996
MEMORANDUM
To: Mary F. Toro. Compliance Officer
Consumer Product Safety Commission
From: Gregory Helms
Office of Solid Waste
Re: Management and Disposal of Waste Vinyl Mini blinds
We have received your questions about management and disposal
of lead-bearing vinyl mini blinds that are being discarded by
homeowners or retailers in connection with your recommendations
that they be replaced due to their potential to cause lead
poisoning. The attachment to this memo restates and answers each
of your questions.
The Resource Conservation and Recovery Act (RCRA) only
applies when blinds become a waste, i.e.. they are being discarded
or disposed: any blinds being sent back to a manufacturer for sale
in other markets (e.g.. for export) would not be regulated under
RCRA. However, given the health concerns about the blinds CPSC has
identified, we hope you will encourage those with stocks of blinds
not to export these products. Key points in managing and disposing
of waste blinds are: 1) waste blinds from households or other
residential buildings may be disposed of as ordinary household
trash (i.e.. they are exempt from Federal hazardous waste
regulation under RCRA); 2) whoever discards blinds from sources
other than households or residential buildings is responsible for
determining whether they contain enough lead to be considered a
hazardous waste, although such a determination can make use of
information from other reliable sources; 3) management and
disposal requirements for hazardous waste blinds vary depending on
the volume of waste being disposed; 4) there is a federal minimum
set of management requirements, but states may have additional
requirements, and should be consulted in planning management and
disposal of waste blinds.
QUESTIONSON LEAD-BEARING MINIBLINDS
1. What is the appropriate disposal method that consumers should
be using for their lead-bearing vinyl miniblinds?
EPA's regulations state that wastes from households (i.e.
garbage and trash) are not regulated as hazardous waste under the
Resource Conservation and Recovery Act (see 40 CFR 26l.4(b)(l)).
Therefore, consumers may dispose of their miniblinds in the same
manner that they discard ordinary household trash. They may put
the blinds out with the garbage, or they may contact a commercial
trash hauler.
2. If consumers have numerous miniblinds in their homes to dispose
of, e.g.. if a household had 15 miniblinds for disposal, would
this be treated differently than a household that had only one or
two miniblinds?
No. EPA's regulations provide that wastes from households
are not regulated as hazardous, and there are no limitations on
the quantity of the wastes.
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Pag
3. What is the appropriate disposal method for apartment
complexes, hotels, military bases and hospital facilities that
house many people and may have over 1,000 lead-bearing miniblinds
to dispose of?
EPA's regulations provide that wastes from single and
multiple residences, hotels, motels, bunkhouses, crew quarters,
and ranger stations are considered household wastes and are not
regulated as hazardous under RCRA (see 40 CFR 261.4(b)). These
facilities may therefore dispose of the blinds in the same manner
that they discard other trash or garbage.
However, hospitals and other non^residential buildings are
not considered generators of household wastes. They are subject to
the same disposal requirements that apply to retailers, which are
described in the answer to question #4 below. Therefore, waste
blinds generated from military base housing units would be exempt.
while waste blinds generated from offices, day care centers, and
other buildings would not be exempted as household waste.
4) How should retailers dispose of the miniblinds they have in
inventory if they decide to dispose of them and not return them to
the place of manufacture? Retailers may have tens of thousands of
blinds in inventory-
Once a retailer decides to dispose of the miniblinds. he
must 1) determine whether they are a hazardous waste (see 40 CFR
262.10 and #6 below), and if they are hazardous. 2) determine his
size status as a generator, because requirements vary depending on
the quantity of a hazardous waste generated. He should then
contact his state hazardous waste agency for more information on
management and compliance in his state because states may have
their own regulations governing hazardous waste.
The retailer can determine his generator status by
calculating how much hazardous waste he or she generates in a
calendar month (40 CFR 262.10(b) and 261.5(b) and (c)). If the
retailer generates less than 100 kg of hazardous waste
(mini-blinds plus any other hazardous waste generated on site)
then the retailer would be classified as a Conditionally Exempt
Small Quantity Generator (CESQG). A retailer who generates between
a 100 kg and 1000 kg of hazardous waste in a calendar month would
be classified as a Small Quantity Generator (SQG): and a retailer
who generates more than 1000 kg of hazardous waste in a single
calendar month is classified as a Large Quantity Generator (LQG).
Conditionally Exempt Small Quantity Generators have minimal
requirements for handling hazardous waste (40 CFR 261.5), and may
dispose of waste blinds in non-hazardous waste facilities,
although disposal must be in state approved facilities. Some
states have additional requirements for CESQGs beyond the Federal
minimum, so retailers should always contact their state hazardous
waste agency for complete information on applicable requirements.
Both SQGs and LQGs are required to handle hazardous waste
under EPA's hazardous waste regulations (40 CFR 262 - 270), and
ultimately ensure their disposal in regulated hazardous waste
disposal facilities. The requirements for SQGs are similar but
less stringent than those for LQGs. Both SQGs and LQGs may be
required to:
? obtain an EPA identification number (40 CFR 262.12)
? prepare the hazardous waste for shipment (package, label,
mark, placard) (40 CFR 262.30 - 262.33)
? manifest the waste for shipment to a hazardous waste
treatment, storage, disposal, or recycling facility (40 CFR
262.20-262.23.262.42)
? manage the hazardous waste on site in an environmentally
sound manner (40 CFR 262.34)
? do record keeping and/or reporting (40 CFR 262.40 - 262-41)
? ensure the waste meets treatment standards before land
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Pat
disposal (40 CFR 268)
? comply with export and import requirements when necessary
(40 CFR Subparts E and F).
Again, some state requirements may vary from the minimum
federal requirements, so contacting the state regulatory agency is
important.
5. Should retailers treat consumer returned merchandise
differently than inventoried products?
As state regulations vary, generators of hazardous waste
should always check with their state hazardous waste authority for
more information on management and compliance.
Assuming the blinds are a hazardous waste, generally.
retailers may dispose of miniblinds returned from consumers and
those from inventoried stock either separately or together. A
retailer who chooses to handle them separately may take advantage
of the household waste exclusion for the blinds returned from
households (see questions 1. 2. and 3). However, the inventoried
stock must be managed as described in the response to question 4.
Because only miniblinds generated in a household (as defined in 40
CFR 2661.4 (b)(l)) are eligible for the household waste exclusion,
the retailer must be certain that miniblinds returned from other
regulated sources such as businesses and commercial facilities are
not mixed with those from households. The miniblinds returned from
sources other than households should be handled along with the
inventoried stock as a regulated hazardous waste.
If a retailer does not wish to segregate different groups of
blinds, or if he wishes to adopt the most environmentally
conservative approach, he may handle both groups together as
described in the response to question 4.
6. Does EPA require testing to determine that waste is hazardous?
Once the retailer (or manufacturer) decides to dispose of
the miniblinds. he is required to determine whether they are a
hazardous waste. This means the retailer must either test a
representative sample of the miniblinds to see if they are
considered a hazardous waste (see #7 below), or the retailer or
manufacturer may also rely on knowledge of the composition and
properties of the blinds in making this determination (40 CFR
261.10(a)(2)). If the retailer does not want to test the
minibiinds. the most conservative approach is to handle all of the
minibiinds as if they were hazardous waste. Although testing is
not required, if subsequent testing by EPA or others demonstrates
that the waste was hazardous, an incorrect determination made
based on knowledge would leave a waste generator (the retailer or
manufacturer) vulnerable to enforcement action.
7. What test method does the EPA recommend to retailers to
determine whether their inventory is hazardous? Are there
certified laboratories that can conduct these tests?
The toxicity characteristic leaching procedure (TCLP;
Method-1311) test would be used to determine whether lead-bearing
vinyl mini-blinds are a hazardous waste when disposed. EPA does
not certify laboratories that perform the TCLP test. However, many
reputable commercial laboratories are capable of performing the
test. Testing labs can be identified by contacting the
International Association of Testing Labs, at 703-739-2188, or
ACIL, at 202-887-5872.
8. Where can retailers get a copy of the test method?
Retailers will generally want to rely on a testing lab to
understand the test method details. Copies of the TCLP test
method are available as a part of the EPA analytic methods manual,
SW-846 (through NTIS, 703-487-4650), or from the analytical
methods information communication exchange (MICE) hotline, at
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Pag
703-821-4690.
9. What level of lead is hazardous for purposes of disposal?
The TCLP test uses a sample of the waste and a leaching
solution (in a ratio of 1:20). After mixing the waste with the
leaching solution, the leaching solution is tested for hazardous
constituent concentration. If lead in the leaching solution is
present at a concentration higher than 5 mg/l (or ppm), the waste
would be considered to be hazardous, and would be required to be
managed and disposed as a hazardous waste.
10. Is there a contact person at EPA that can offer retailers
guidance on disposal if their inventory is determined to be
hazardous?
For further assistance in understanding the applicable
hazardous waste regulations, the retailer should contact the
hazardous, waste agency in his or her state. Other assistance
resources include the EPA Resources Centers, the RCRA hotline
(800/424-9346 or 703/412-9810), or the EPA Regional office.
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rage i or J.
Fax Back? I 1012
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF SOLID WASTE
MAY 13,1981
OFFICE OF WATER
AND WASTE MANAGEMENT
Mr. Steven C. Wittmer
Environmental Facilities Engineer
MERCK SHARP & DOHME
West Point, Pennsylvania 19486
Dear Mr. Wittmer
Your letter of March 26. 1981 requests our interpretation of the RCRA hazardous waste regulations as applied to products eventually discarded
at your West Point plant.
40 CFR §261.33 is the controlling provision: the materials you describe, including U245, become hazardous wastes "if andvvhen they are
discarded or intended to be discarded...". [Emphasis added]. We underscore the word "when" because the event of discard, or the time of
decision to discard, is determinative. Until a material referenced by section 261.33 is actually discarded, or the decision is made to discard the
material, it is not subject to RCRA regulation.
As we understand, the decision by Merck Sharp & Dohme whether to discard a given product is not made until after the product has been
returned to the West Point plant, following a check by your Security Department. Moreover, as we understand, your procedures for segregating
returned goods for reclamation or disposal via either incineration or landfill take place only at the West Point plant. Given these facts, and
assuming that your branch operations have no role in the decision to discard a particular material, we conclude, as to materials in the form of
commercial chemical products on the P or U lists of 40 CFR§261.33, that the materials are not yet within the RCRA regulatory system when
shipped to West Point from the branch operations. We agree with your reasoning that West Point is "the place where the goods become a
waste."
I trust this interpretation will be helpful. If I can be of further assistance, please let me know.
Sincerely yours,
Alan S. Corson
Chief
Waste Characterization Branch
Hazardous and Industrial Waste Division (WH-565)
MSD
MERCK
SHARP
DOHME
DIVISION OF MERCK & CO.. INC., WEST POINT. PENNSL YVANIA I94S5
March 26, 1981
Mr. Alan Corson,
Chief-Waste Characteristics Branch
Hazardous Waste Management Division (AW-465)
Office of Solid Waste
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington. D.C. 20460
Dear Mr. Corson:
I recently had the opportunity to meet with Ms. Claire Welty from your office, at our plant on March 6, 1981. During her visit. 1 briefly
summarized a matter concerning hazardous waste management that has been of concern to our Company. Ms. Welty recommended that we
submit this matter in writing to your office for consideration.
Merck Sharp & Dohme, Division of Merck & Co., Inc., is located in West Point, Pennsylvania where we manufacture ethical pharmaceutical
and biological products. Finished goods are shipped to sixteen branch operation facilities located throughout the country. The finished goods
are then distributed to customers from the branch operation facilities. A small percentage of the finished goods are returned to the branch
operation facilities on a regular basis. Usually returns occur when a pharmacist has kept a product beyond the expiration date. Occasionally, a
pharmacist may return a product for some other reason, such as lack of sales. Also, a product may be returned if we initiate a recall for any one
of numerous reasons. These return goods are shipped from all sixteen branches to our West Point plant.
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rage 2. or z
Most return goods shipped to West Point are discarded either for business reasons or because Food and Drug Administration regulations
prevent us from recovering them. Once they reach the plant, return goods are disposed, but only after they have been checked at our plant unde
the supervision of our Security Department. They are either incinerated or transferred to a solid waste crusher for destruction prior to being
landfilied. In this manner, we can account forand control the disposal of all return goods in a uniform manner at a central location. The
centralized control of our return goods has been practiced effectively for over 30 years. It is essential to our standards of practice to assure
uniformity in handling products, even when discarded.
After careful review of the Part 261 regulations, Identification and Listing of Hazardous Waste, we have determined that some of our return
goods should be ultimately disposed of as a
U.S Environmental Protection Agency
March 26. 1981
hazardous waste. Accordingly, we have established procedures to segregate the return goods so that proper disposal can be assured.
One of our products was listed as an acutely hazardous waste (P025) on May 9, 1980 but was reclassified as a toxic waste (U245) on
November 25. 1980. Since it was unknown at the time the regulations went into effect whether or not the return goods shipment to West Point
contained more than 1 kilogram of that product each month, it was determined that each of our branch operations facilities should register as a
generator and a treatment, storage, disposal facility (TSDF). This included notification of all ten EPA Regional Administrators. The TSDF
portion of the notification has since been withdrawn based on an evaluation of our standard operating procedures. We have not withdrawn the
generator notification because we are not sure if the branch operation facility is a generator of hazardous waste or if the West Point plant is the
generator of hazardous waste for that fraction of return goods ultimately disposed as hazardous waste.
In the comments preceding the regulations, the EPA stated that "any material whichis intended to be or is in fact thrown away, abandoned or
destroyed is a "waste", (emphasis added). Because most return goods are discarded, it remains unclear to us whether or not the "intent to
discard" language in the preamble to the regulations means that the branches' return shipments to West Point, in the absence of the small
quantity provisions, would be subject to the requirements of Parts 263 and 264. If branches are generators we face the probability that we will
have to establish different return goods procedures for branches located in states whose regulations vary from the federal ones. The resulting
loss in uniformity would present increased potential of security and administrative problems.
However, since branches have authority only to return the goods to West Point and only the West Point site has authority to actually discard the
goods, we believe that it is reasonable to regard West Point as the place where the goods become a waste. This interpretation is consistent with
the regulations' purpose of assuring proper disposal of wastes, since all return goods are tracked under ourinterna! system and the disposal of
goods would be managed in compliance with hazardous waste regulations where applicable. Following this approach, we would not have to
establish different compliance procedures in different states according to their generator standards, and we could maintain a uniform procedure
Uniformity in procedures results in better security and control, which, in turn, helps to assure compliance with the hazardous waste regulations.
U.S. Environmental Protection Agency
March 25, 1981
As it is our objective to comply with the hazardous waste regulations, we would appreciate your review of our situation to determine whether
our interpretation is correct that insofar as returned goods are concerned, our branch operation facilities are not subject to the hazardous waste
generator standards of the regulations. Thank you for your cooperation in this matter.
Very truly yours.
Steven C. Wittmer. Environmental Facilities
Engineer. Facilities Engineering
SCW:ca
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UNITED ATES ENVIRONMENTAL PROTECTION *. .NCY
Mr. Joseph E. cothern
Environmental Protection Specialist
Department of the Air Force
HQ Aerospace Guidance and Metrology Center (AFLC)
Newark Air Force Station, Ohio 43057-5000
Dear Mr. Cothern:
This letter is in response to your letter dated February 2,
1989, in which you requested an assessment and characterization
of beryllium wastes generated at Newark Air Force Station.
In follow-up conversations with you on February 10, 1989 and
February 13, 1989 to obtain more information related to the
process involved, you indicated that the beryllium is generated
in the form of. a very fine dust. In order to meet the
Occupational Safety and Health Administration (OSHA) worker
protection standards and the National Emission Standards for
Hazardous Air Pollutants (NESHAPS), the airborne dust is
collected by vacuum hoods and directed through a two stage
filtration system. As I understand the vacuum-filtration
process, the system consists of the following components:
vacuum hood
10-foot tube
air trap
cyclone hopper (with a bag filter located on top of hopper)
collection container
vacuum unit (with three filters inside)
The dust-laden air initially enters the vacuum hood located
on the ceiling of the grinding/polishing room and travels up the
10-foot tube. It then enters an air trap in which heavier
particulars matter is collected. The lighter air-suspended
particle* are then channeled into a cyclone hopper. A bag filter
is situated at the top of the hopper. This is the first
3/£i
f.~. 1320-1 OJ-70)
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•A
filtratifl* stage. The vacuum unit, which provides suction for
the entire system, is attached to the outside of the hopper. The
vacuum unit houses the final filtration element, which consists
of three filters. This second filtration stage traps the ,
remaining dust in the air before it is discharged into the
ambient air.
The collection container is detached from the hopper and
vacuum unit when it is filled to capacity with dust, two percent
of which is beryllium. It is then replaced with a new container.
The subsequent management practice is to stabilize/solidify the
dust in cement prior to disposal. The container filled with
concrete (stabilized dust) is then sent off site to a disposal
facility.
The final filtration element, on the other hand, has never
been replaced since the start-up of the operation. As I
understand the current operating procedures, the final filtration
element will eventually be discarded when gross dust
contamination renders it useless.
The materials that you wish to characterize are the final
filtration element, the beryllium dust, and the dust collection
container. To identify the materials as hazardous waste under
Subtitle C of the Resource Conservation and Recovery Act , they
must first be classified as solid wastes under 40 CFR Section
261.2. Based on information you provided over the phone, the
final filtration element, the solidified dust (concrete), and the
container holding the concrete are abandoned by land disposal
and, therefore, meet the definition of solid waste [40 CFR
Section 261.2(b)(1)].
Based on the additional information you provided over the
phone about the subassembly grinding/polishing and air filtration
process, I have concluded that the dust is not a commercial
chemical product (i.e., P015) and is not any other listed
hazardous waste identified in 40 CFR Part 261, Subpart D. The
solidifi«* dust, the container holding the solidified dust, and
the finaJfrfiltration element contaminated with dust also are not
RCRA listJBB hazardous wastes. If the dust does not exhibit a
hazardorfwaste characteristic (prior to solidification) as
defined in 40 CFR Part 261, Subpart C, the dust is not a
hazardous waste and is not regulated under RCRA Subtitle C.
Also, if the filter element contaminated with the dust does not
exhibit a hazardous waste characteristic once rendered useless,
it is not regulated under Subtitle C of RCRA.
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If tfce dust and the filter element do exhibit a hazardous
waste characteristic, then the material must be managed according
to RCRA Subtitle C regulations. The solidification of the dust
with cement would then be treatment of a hazardous waste and a
RCRA permit may be required.
)
The above information lays out the applicability of Federal
regulations pertaining to the materials in question. Please be
advised that States may have regulations that are more stringent
or broader-in-scope than those of the Federal government. You'
should contact the appropriate State agency to determine the
applicability of their regulations.
If you have any additional questions, please contact Steve
Cochran of my staff at (202) 475-8551.
Sincerely,
Devereaux Barnes, Director
Characterization and Assessment
Division
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9441.193J
[388
Ms. Jane Ma-gee
Assistant Corr.iss icner for
3d id and Hazardous Waste Management
Indiana Dept. of Environmental Management
P.O. Box 6215
Indianapolis, Indiana 46226-6315
Dear Jane:
This is .n response to your letter on the applicability of
Resource Conservation and Recovery Act (RCRA) regulations to
shooting ranges. In your letter you indicated that the Indiana
University in Bloomington ,has received a preliminary notice of
intent to sue under RCRA, alleging that the university shooting
ranges are hazardous waste landfills, fully subject to the
requirement for an operating permit and all applicable facility
standards. •
The discharge of ball and sport ammunition at shooting
ranges does not, in our opinion, constitute hazardous waste
disposal. This is because we do not consider the rounds to be
discarded, which is a necessary criterion to be met before a
material can be considered a solid waste and/ subsequently, a
hazardous wast* (see 40 CFR 261.3(a)). Rather, the shooting of
bullets is within the normal and expected use pattern of the
manufactured product. This interpretation extends to the
expended cartridges and unexploded bullets that fall to the
ground during the shooting exercise. The situation, in our
mind, is analogous to the use of pesticides whereby the
expected, normal use of a pesticide may result in some
discharge to the soils. This is a discharge incident to normal
product use and is not considered a hazardous or solid waste
activity falling under the jurisdiction of RCRA.
0
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If y- _: r.3ve ar.y r_est.cr.s recsrcir.r t_r i-.zercr-=ca 11 cr. t:
:ld l:-:e ~: discuss t^-e iss-e f-rtr.er, p.-=a£= call Elizacet
:swortr. '2-22. 2:2-2122 or r.-.et Oszrrar. 222; 2S2-.449S.
\ A
Sylvia K. Lowrar.ce
Director
Office of Solid Waste
Elizabeth Cctswcrtr.
v.att Hale, OSW
Free Chanar.ia, OGC
Karl Bre.T.er, Region 5
Chet Oszr.an, OSW
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9443.1988(03J
MAft 2 2 !9S8
Steve Simpson
Chief Process Engineer
Associated Technologies, Incorporated
212 South Tyron Street, Suite 300
Charlotte, NC 28281
Dear Mr. Simpson:
This letter is in response to your January 25 letter to
Marcia Williams regarding the regulatory status of asphalt
materials used at Associated Technologies, Incorporated.
Specifically, you requested a determination as to whether the
asphalt is a hazardous waste.
If the asphalt were to be used as a commodity, e.g. , for paving
roads, then it would not be regulated under the hazardous waste
regulations. However, since the asphalt is disposed (buried in a
trench) it is a solid waste. In the RCRA program, wastes are
defined as hazardous if they: (1) are included on the lists of
hazardous wastes contained in Subpart D of 40 CFR Part 261 or are
derived from, or are mixtures containing, such wastes; or (2)
exhibit any of the hazardous waste characteristics described in
Subpart C of 40 CFR Part 261 (i^s^., ignitability, corrosivity,
reactivity, or extraction procedure
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- 2 -
Please note that the interpretation is based upon the
information contained in your January 25 letter and reflects
current Federal regulations. Since State and local regulations may
differ, you are encouraged to contact these authorities to ensure
that you are aware of all applicable regulations. Should you have
any questions regarding this interpretation, please contact David
Topping of the Waste Characterization Branch at (202) 382-7737.
Sincerely,
Sylvia K. Lovrance
Director
Office of Solid Waste
WH562B/DTopping/tle/rmS242/382/7737/2/12/88/DTopping-CSCC-8701
bc/2/16/88
bC/2/22/88
tle/3/3/88
bc/3/11/88
tle/3/14/88
bC/3/22/88
cc: Emily Roth
David Topping
Dr. Malcolm Knapp
U.S. Nuclear Regulatory Commission
I!!!!!!!! I I I ! ! ! ! I 1 1 I ! I I I ! ! Ill I !!!!!! !l ! ! ! I ! 1 I ! ! !! ! !!! 1 ! I !!!!!!!!!!!!
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9443.1987(2
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C. 20460
301987
• SOuO
Mr. Phillip C. McGuire
Associate Director, Law Enforcement
Department of the Treasury
Bureau of Alcohol, Tobacco and Firearms
Washington, D.C. 20226
Dear Mr. McGuire:
Thanx you for your October 14, 1987, letter regarding the
disposal of explosive materials under the Resource Conservation
and Recovery Act (RCRA). We have reviewed the information you
provided concerning the detonation of seized explosives that you
believe would not fall under the RCRA Subtitle C program. We
thinx, however, that the seized explosives may indeed be a solid
waste from the moment a decision is made that the explosives
must be destroyed and not returned to the original owners.
The basis for the Environmental Protection Agency's (EPA)
opinion is that the explosives are not being used for their
originally-intended purpose (e.g., demolition of a building,
military use, etc.), but rather are being detonated to discard
the materials. The explosives, therefore, would meet the
definition of a solid waste as defined in 40 £ZB Section
261.2(a) and (b). If these explosives exhibit the
characteristic of reactivity as defined in 40 C£K 261.23, they
would be subject to the RCRA hazardous waste regulations for
storage, treatment and disposal. For example, detonation of
reactive waste is considered a form of thermal treatment that is
subject to Section 265.382, and shipments to the disposal site
are subject to 40 era Parts 262 and 263.
we recognise the Bureau of Alcohol, Tobacco and Firearms
(BATT) has considerable experience in handling explosives. Your
internal procedures appear to be comparable to EPAfs rules in
many respects. There are, however, some differences that may
need to be examined. For example, you state that the detonation
areas must be at least 1,000 feet from buildings, woods, etc.
EPA's regulations (Section 265.382) require farther distances
for quantities in excess of 100 Ibs.
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Ul 10 STAT. ENVIRONMENTAL PROTEC i lON AGEN,
9444.198612C
Mr. William L. Warren
Warren, Goldberg, Herman, and Lubitz
112 Nassau Street
P.O. Box 645
Princeton, New Jersey 08542
Dear Mr. Warren:
This is in response to your letter of August 26, 1986,
in which you reguest that EPA confirm that soil contaminated
with Chlordane, as a result of application of that pesticide
in the normal course of agricultural use, would not automatically
be considered a hazardous waste.
The pesticide Chlordane is a listed commercial chemical
product (U036; see 40 CFR 261.33(f)) that becomes a hazardous
waste when discarded or intended to be discarded. The Agency
did not intend to cover those cases when the chemical is
released into the environment as a result of use. (See, for
example, the enclosed memo regarding the regulatory status of
pesticide applicator washing rinse water.) In addition, 40 CFR
261.2(c)(1)(B)(ii) specifically states that commercial chemical
products listed in Section 261.33 are not solid wastes (and,
thus, not hazardous wastes) if they are applied to the land
and that is their ordinary manner of use. Therefore, the
contaminated soil would be treated as a hazardous waste (if
it is dug up) only if it exhibits one or more of the four
RCRA hazardous waste characteristics defined in 40 CFR 261.21
through 261.24.
Please feel free to contact Mr. Matthew A. Straus if you
have any further questions; Mr. Straus can be reached at (202)
475-8551.
Sincerely,
Eileen B. Clau««en
Di roc tor
". Characterization and
Assessment Division
Enclosure
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With respect to -the toxicity, the Agency has not yet
evaluated the health effects of these gases. Propane is,
however, on th« Pood and Drug Administration's GRAS list
(Generally regarded as Safe). As noted above, propane,
butane, and isobutane are all flammable gases. Upon direct
contact to each of the compounds in the liquid forms, they
•nay cause burns or frostbite to the skin and eyes. All
three compounds, at high levels of exposure, are anesthetic
and -nay cause narcotic and asphyxiating effects. Thus, with
respect to their properties and toxicity, butane and isobutane
are si.nilar to those of propane.
I hope this information is useful to your constituent.
I am pleased that we can be of assistance to you. If you
have any further questions concerning this matter, please
contact Dr. Howard M. Fribush or Ambika Bathija of my staff
a.t 475-8551.
Sincerely,
J. Winston Porter
Assistant Administrator
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* UNITED STATES ENVIRONMENTAL PROTECTIC
f WASHINGTON, DC. 204«0
-**-
Honorable Buddy Roemer
House of Representatives
Washington, *3.C. 20515
Dear Mr. Roemer:
you for your letter requesting information on the
toxicity and regulation of isobutane and butane Bastes. The
Agency has promulgated, regulations which address these chemicals
as wastes.
Isobutane and butane are hydrocarbon gases at normal
temperatures. When these chemicals are containerized and
1L «»«:•* M«*i, f.'ia containers meet the definition of solid waste
as outlined in 40 CFR 260.41 (solid liquid, semi-solid or
cont-iin-il j-*seous material). Isobutane and butane also
would meet the definition of an ignitable hazardous waste,
as defined in 40 CFR 261 .21 (a) (3) . If, however, the chemicals
are released from the container, they would volatilize and
would no longer meet the definition of solid waste. In
addition, 40 CFR 261.7 provides guidance on residues of
hazardous waste in empty containers. If residues of the
chemicals remain in an empty container, the chemicals are
not *-tV>j
-------
I would like to suggest that EPA staff meet with your staff
to discuss how to reconcile the RCRA rules as they apply to BATF
detonation activities. Rulemaking efforts may be required of
both agencies to resolve any inconsistencies, in order to
schedule a meeting that will be mutually convenient, please
contact Mike Petruska, of my staff, on 475-8551. we believe
that this meeting will provide the opportunity to discuss
several points including what rulemakings may have to be
undertaken by either agency, and what exemptions may be
possible.
If I can be of any further assistance-, please let me know.
-xSincerely,
, Winston Porter
jsistant Administrator
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9443.1986(11
:ir. William R. blackburn
Travenol Laooratories, Inc.
jeertield, Illinois 60U15
Dear Mr. Blackburn:
This is in response to the letters you have suomittea
to the Agency in which you raise a number of questions tor
our consideration. First, let me apologize for tne time it
has taken to respond to your letters; I hope this has not
created any problems for you. You first request that we
confirm that the deionization (DI) acid that is generated
at Travenol's plant in Cleveland, Mississippi is not a
waste. Based on the information provided,!/ we agree with
you that the DI acid is not a waste and, therefore, is not
subject to the Federal hazardous waste rules. In particular,
before a material can be a hazardous waste, one must first
determine whether tne material is a solid waste. In general,
corrosive materials that are neutralized are normally considered
wastes. However, where such corrosive materials can oe
shown to: (1) meet relevant specs with regard to contamination
levels, (2) be as effective as the virgin material for which
they substitute, and (3) be used under controlled conditions,
we believe such materials may not be wastes. The information
provided in your letters clearly indicate that the OI acid
generated at your Cleveland plant is benefically reused and,
therefore, is not a waste. Ac a result, this material is
not subject to the Federal hazardous wast* rules. This
material would be subject, however, to any state regulations.
with respect to your request regarding the exclusion
and whether it applies retroactively under tne old regulations,
we believe that since the 01 acid has always been benefically
See letters dated: November 14, 1985, from William K.
Blackburn to Jack Lehman; uecember 5, I*tf5, trom Micnael bmitn
to Robert Tonetti; January 13, 1986, from Micnael Smitft
to Matthew Straus; February 6, 1945, trom William R. Blackburn
to Matthew Straus; and April 17, 1986, from Michael Smith
to Matthew A. Straus.
-------
recycled and since this acid is neither listed nor a sluage'.
this material is not now (and has never been) subject to
regulations. Therefore, Travenol does not need to go through
closure cor this impoundment; we have discussed this inter-
pretation with our Office or General Counsel and they agree.
Finally, you requested written explanation as to why no
hazardous waste permit is required to dispose or the alcohol
to the era in; a verbal response was provided to you by
Ms. Irene Homer. A written response, however, has been
prepared and should be sent to you shortly.
Please feel free to give me a call if you have any
turther Questions.
Sincerely
Marcia E. Williams
Director
Office of Solid'Waste
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9441.1984(36)
S 1 7 1984
o
2
SUBJECT* RCRA Implications of Treating Gases
Vented from Compressed Cylinders
PROM: John Skinner, Director
Office of Solid Waste (WH-562B)
TO: James H. Scarbrough, Chief
Residuals Management Branch
Region IV
This is in response to your November 28, 1984, memorandum
regarding a facility built to treat fluorine (P056) and other
gases vented from compressed gas cylinders. You are correct
in your application of the response to the letter to the
Compressed Gas Association from Christopher Capper, dated
November 6, 1981.
According to that letter, customers return cylinders to gas
suppliers for refilling, not for disposal, and no waste is involved.
If the gas supplier decides to discard the contents of the returned
cylinders, any liquid or physically aolid wajtea removed from
the cylinders are guh^**-t; »r» prp* if they are hazardous waste.
Cylinders containing regulated quantities of hazardous waste
would need to be manifested to off-site facilities for treatment,
storage, or disposal. However, the letter goes on to aay that
the handling—oJL yaseousres_idues renoved from the cylinders and
neutralization or scrubbing of "gases~prior to release are not
subject to RCRA regulation. Any liquid or physically aolid
wastes derived from the treatment of hazardous compressed gas
is at ill subject to RCRA regulations, if it is derived from listed
waste or if the residual ia hazardoua under Part 261 Subpart C
(characteristics).
Therefore, your conclusions are correct. The facility is not
a RCRA treatment facility for any handling of the gases renoved
from the cylinders. Any liquid or aolid residues derived frota
the cylinders or from treatment of cylinder contents that are
listed in 40 CFR 261 Subpart D or ara hazardous under Part 261
Subpart C are subject to Subtitle C hazardous waste regulations.
If you have any further questions, please do not hesitate to
contact Alan Corson or Irene Horner, of my staff, at 382-4770.
cct Hazardous waste Branch Chiefs, Regions I-III and V-X
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Solid Waste
Exclusions
-------
Exhibit II
Solid Waste Exclusions
(Most don't apply to hospitals. General Reference.)
Overheads from Presentations
Relevant Federal Regulatory Citations
RCRA Policy Excerpts
EPA Region 2 42
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Exhibit II-1
A Discarded Material Is Not A Solid Waste If It Is
Specifically Excluded From Regulation
261.4(a)
•The regulations specifically exclude certain materials from being considered solid waste.
•Many of these exclusions are specified inRCRA - the statute.
•There are also certain materials which are recycled and are not considered solid waste - those will be discussed under the recycling section of this training
manual.
EPA Region 2 43
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Exhibit II-2
Solid Waste Exclusions
• Domestic sewage, and any mixture of domestic sewage and
other wastes, that passes through a sewer system to a POTW for
treatment (307(b) of CWA)
• Industrial wastewater discharges that are point source discharges
subject to regulation under Section 402 of the Clean Water Act
• Irrigation return flows
• Source, special nuclear or by-product materials as defined by the
Atomic Energy Act. Some radioactive wastes are regulated
under RCRA, such as mixed wastes.
261.4(a)(l),(2),and(3)
•Domestic sewage refers to untreated sanitary wastes.
•The exclusions are because domestic sewage and industrial sewage are managed under the Clean Water Act.
•Note however, that the exclusion for industrial waste waters does not apply to the system -just the end of pipe.
•This exclusion applies only to the actual point discharge, not to wastewater while being collected, stored, or treated, or to sludges generated by industrial
wastewater treatment.
•Irrigation return flows may carry pesticides which meet the definition of "discarded commercial chemical products" but the waters are regulated under the
Clean Water Act.
EPA Region 2 44
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Exhibit II-3
Solid Waste Exclusions (Cont'd)
• Definition of mixed waste: waste that satisfies the definition of low-level
radioactive waste (LLW) in the Low-Level Radioactive Waste Policy Amendments
Act of 1985 (LLRWPAA) and contains hazardous waste that either (1) is listed as a
hazardous waste in Subpart D of 40 CFR Part 261 or (2) cause the LLW to exhibit
any of the hazardous waste characteristics identified in Subpart C of 40 CFR Part
261.
• In Region 2, NY and NJ have authority to regulated mixed waste (PR and the VI
do not).
Typical hospital mixed waste includes spent radiopharmaceuticals and nuclear
medicine. Most hospitals store mixed waste until they are no longer considered
radioactive and dispose of them properly.
• If you opt to dispose of mixed waste while still radioactive, make sure you send it
to a suitable treatment facility (e.g. one that is NRC approved).
261.4(a)(4)
•AEA exclusion was specified in RCRA. The waste exclusion resulted in a controversy regarding wastes which are both radioactive and meet the definition of
RCRA-regulated hazardous waste. On July 3, 1986, EPA issued a clarification in the Federal Register that stated that the exclusion was limited to
radionuclides - not the entire waste matrix. The FR notice also explained that states must obtain authorization for mixed wastes. Until then, mixed wastes
were not regulated in already-authorized states. As of 10/1/2003, 48 states had mixed waste authorization and 2 states were unauthorized.
EPA Region 2 45
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Exhibit II-4
Solid Waste Exclusions (Cont'd) -
Not Hospital Related
• Materials subjected to in-situ mining techniques and which
remain in the ground
• Pulping liquors reclaimed in pulping liquor recovery furnace
and then reused in the pulping process, unless accumulated
speculatively
• Spent sulfuric acid used to produce virgin sulfuric acid,
unless accumulated speculatively
261.4(a)(5),(6),and(7)
•In-situ means the wastes never see the light of day - they basically stay where they began.
•These second two exclusions are the results of effective lobbying effort by the paper and chemical industries. Basically, these wastes are regularly
reclaimed and reused in the process in which they are generated.
EPA Region 2 46
-------
Exhibit II-5
Solid Waste Exclusions (Cont'd) -
Not Hospital Related
• Secondary materials reclaimed and returned for reuse to
original process in which they were generated, provided:
- Only tank storage is involved
- Closed process
- Reclamation does not involve controlled flame combustion
- Less than 12 months accumulation prior to reclamation
- Reclaimed material is not used to produce a fuel
- Reclaimed material is not used in a manner constituting
disposal
261.4(a)(8)
•This exclusion is intended to provide a more general exclusion to exempt materials which are normally returned to the process in which they were
generated. The conditions which apply are meant to make sure they don't get out into the environment. If they do - they lose their exclusion and are
considered solid wastes.
EPA Region 2 47
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Exhibit II-6
Solid Waste Exclusions (Cont'd) -
Not Hospital Related
• Spent wood preserving solutions that have been used and
are reclaimed and reused for their original intended purpose
• When used as a fuel, coke and coal tar from the iron and
steel industry that contain or are produced from decanter
tank tar sludge (K087)
261.4(a)(9)and(10)
EPA Region 2 48
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Exhibit II-7
Solid Waste Variance
• Opportunity to obtain case-by-case variances from a
Regional Administrator found under
- 260.30
- 260.31
- 260.33
• Possible situations
- Materials accumulated speculatively without sufficient
amounts recycled
- Materials reclaimed and reused within original process
- Materials incompletely reclaimed
•If a material doesn't meet one of the specific exclusions in 261.4(a), the regulations provide the regulated community with a variance.
•The variance, in 260.30, notes the above situations in which, on a case-by-case basis, a material may still be excluded from being defined as a solid waste.
•The Regional Administrator makes the decision based on criteria set out in 260.31 and in accordance with procedures found in 260.33.
EPA Region 2 49
-------
Exhibit II-8
Relevant Federal Regulations
40 CFR Part 260
260.30
260.31
40 CFR Part 261
261.4(a)
EPA Region 2 50
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S *„ f
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Wastes: Solvent-Contaminated Industrial Wipes Page 1 of 2
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EPA Home > Wastes > Waste Identification > Solvent-Contaminated industrial Wipes
Solvent-Contaminated Industrial Wipes
Hazardous Waste Management System: Identification and Listing of
Hazardous Waste: Conditional Exclusions from Hazardous Waste and
Solid Waste for Solvent-Contaminated Industrial Wipes; Proposed Rule
- November 20, 2003
EPA is proposing to modify its hazardous waste management regulations under the Resource Conservation
and Recovery Act for certain solvent-contaminated materials, such as reusable shop towels, rags,
disposable wipes and paper towels. Specifically, EPA is proposing: to conditionally exclude from the
definition of hazardous waste disposable industrial wipes that are contaminated with hazardous solvents
and are going to disposal; and, to conditionally exclude from the definition of solid waste reusable industrial
shop towels and rags that are contaminated with hazardous solvents and are sent for laundering or dry
cleaning (hereinafter referred to as disposable industrial wipes and reusable industrial wipes, respectively).
This proposal affects contaminated industrial wipes being sent to both landfill and non-landfill (e.g.,
laundries and combustion) facilities and is applicable to: industrial wipes exhibiting a hazardous
characteristic (i.e., ignitability, corrosivity, reactivity, or toxicity) due to use with solvents; or industrial wipes
contaminated with F001-F005 spent F-listed solvents or comparable P- and U-listed commercial chemical
products that are spilled and cleaned up with industrial wipes.
This proposal would resolve, at the federal level, long-standing issues associated with the management of
solvent-contaminated industrial wipes by: facilitating pollution prevention and waste minimization
opportunities, including the recycling of the spent solvents extracted from contaminated industrial wipes;
fostering improved solvents management by generators and handling facilities; reducing compliance costs;
increasing consistency in the regulations governing solvent-contaminated industrial wipes across the United
States; clarifying existing federal rules; and creating flexibility for generators to work with industrial laundries,
as appropriate, to ensure compliance with local pretreatment standards established by Publicly Owned
Treatment Works (POTWs).
Additionally, the proposal contains the Agency's proposed response to rulemaking petitions filed by the
Kimberly-Clark Corporation and the Scott Paper Company.
Background information for this notice is available through EPA's electronic public docket and comment
system, EPA pockets. The docket number is RCRA-2003-0004.
Federal Registers:
• Proposed Rule - November 20, 2003
Adobe PDF File [255 KB] || HTML
• Extensionof Comment Period -January 30, 2004
Adobe PDF File [36 KB]
EPA Proposes Conditional Exclusions from the Definition of Hazardous Waste and the
Definition of Solid Waste For Solvent-Contaminated Wipes [Fact Sheet]
Adobe PDF File [15 KB]
http://www.epa.gov/cgi-bin/epaprintonly.cgi 2/22/04
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vf, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^ Region 1
1 1 CONGRESS STREET, SUITE 1100
y BOSTON, MASSACHUSETTS 02114-2023
f
December 11,2001
Mr. Edward W. Pickering
Environmental Science Services, Inc.
272 West Exchange Street, Suite 101
Providence, Rhode Island 02903
Re: Applicability of Household Hazardous Waste Exemption in University Dormitories
Dear Mr. Pickering:
Thank you for your letter of June 19, 2001 to Mr. Ken Rota requesting clarification of the
applicability of the exemption for household hazardous waste (HHW) in 40 CRF 261.4(b)(l).
Specifically, you asked whether this exemption applies to certain wastes generated in dormitories
and other housing facilities owned and operated by colleges and universities?
The following are the two scenarios that you described in your letter, and our responses.
1. A student completes homework assignments in his/her private room in a dormitory or other
housing facility. Some assignments, such as art and modeling projects, result in generator of
spent solvents, paints and other wastes that would meet the definition of listed hazardous
waste and/or characteristic hazardous wastes. Are these wastes exempt under the household
waste exemption?
Response: In order for a waste to meet the HHW exemption, it has to meet two criteria: the
waste must be generated by individuals on the premises of a temporary or permanent residence,
and be composed primarily of materials found in the wastes generated by consumers in their
homes. (49 FR 44978: November 13, 1984). In general, EPA would consider wastes from
student art and modeling homework assignments generated in this manner to be exempt under
the household hazardous waste exemption. The exception would be if homewoik assignments
were given for the purpose of avoiding regulation. For example, a university could not claim the
HHW exemption for laboratory waste by setting up its laboratory facilities in dormitories.
2. A University provides a workroom within a dormitory or other housing facility for students to
complete homework assignments, including art and modeling projects. The workroom is
equipped with a sink and collection containers for wastes generated from student projects.
The University provides these collection containers as a good management practice to
promote proper handling of these wastes. Periodically, these collection containers are
brought to one of the university's hazardous waste storage areas. Is the waste collected in the
workroom exempt from RCRA regulation under the household waste exemption? Can the
university bring this waste to one of its waste storage areas as a generator without being
classified as a treatment, storage, and disposal facility (TSDF)?
Toll Free-1-888-372-7341
Internet Ad dress (U RL) http:.?www.epa.gov
Recycle/Recyclable Printed with Vegetable Oil Based Inks on Recycled Paper (Minim um 25 % Postconsumer)
-------
Mr. Edward W. Pickering
Page 2
Response: In general, EPA also would consider wastes from student art and modeling homework
assignments generated in this manner to be exempt under the household hazardous waste
exemption. Again, the exception would be if homework assignments were given for the purpose
of avoiding regulation.
A university will not become a TSDF under the federal regulations simply by bringing exempt
HHW from a dormitory to one of its hazardous waste storage areas. Rather, the HHW will
become subject to regulation as a newly generated hazardous waste when it is commingled in the
hazardous waste storage area with other non-exempt hazardous waste. All of the wastes in such
a central storage area should then be stored and ultimately disposed in accordance with all
applicable hazardous waste requirements.
Finally, you should consult with each State in which a university is located. Each State may have
more stringent requirements, or a more stringent interpretation of the above requirements.
I hope the above responses address your concerns. Ifyou have any further questions on this
letter, please contact either Jui-Yu Hsieh or Stephen Yee of the Hazardous Waste Unit at
(617) 918-1646 or (617) 918-1197, respectively.
Sincerely,
Marv Rosenstein, Chief
Chemical Management Branch
Office of Ecosystem Protection
Associate Director of Waste Policy
cc: Ken Rota, EPA-OES
Gary Gosbee, EPA-OEP
Jeffrey Fowley, EPA-ORC
Laurie Grandchamp, PJ DEM
Stacy Ladner, MEDEP
Peter Marshall, VT DEC
Bill Sirull, MA DEP
John Duclos,NH DBS
Dave Sattler, CT DEP
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NRC: EA-99-171 - Arthur Brisbane Child Treatment Center Page 1 of:
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fiome > Electronic Reading Room > Document Collections > Enforcement Documents > Significant Enforcement Actions > Materials
Licensees > EA-99-171
EA-99-171 - Arthur Brisbane Child Treatment Center
August 16,.2001
EA No. 99-171
Raymond C. Grimaldi
Chief Executive Officer
Arthur Brisbane Child Treatment Center
State of New Jersey
Department of Human Services
Div. Of Mental Health Services
P.O. Box 625
Farmingdale, NJ 07727
SUBJECT: NOTICE OF VIOLATION (NRC Inspection 99990001/1997023, and NRC Office of Investigations Report No. 1-
97-050)
Dear Mr. Grimaldi:
This refers to the inspection conducted on October 30, 1997, and November 20, 1997, at the Arthur Brisbane Child
Treatment Center (Brisbane) in Farmingdale, New Jersey, to review the circumstances associated with an event which
occurred at your facility on October 29, 1997, wherein an exit sign, containing 12 curies of tritium, was broken and resulted
in radioactive contamination of a portion of the facility. You were authorized to possess and use such exit signs pursuant to
a general license contained in 10 CFR 31.5. Subsequent to the inspection, the NRC Office of Investigations (OI), Region I,
initiated an investigation to determine if Brisbane, which is operated by the State of New Jersey Department of Human
Services (DHS), willfully and improperly disposed of the broken generally licensed exit sign (along with contaminated
asbestos floor tiles and other contaminated objects) by improperly transferring the material to SMI, East Coast Medical
Waste, Inc. (SMI), a medical waste broker who was not authorized to receive radioactive waste.
Based on the OI investigation, the NRC found that, as a result of the deliberate actions of the DHS Chief of the Bureau of
Environmental Compliance (DHS official), Brisbane improperly disposed of the radioactive material generated from the
cleanup of the broken exit sign. The radioactive material was transferred to SMI, located in Morrisville, PA, who in turn
transferred it to Safety Disposal Systems, Inc. (formerly known as Chambers Medical Technologies of South Carolina), a
medical waste incinerator facility in South Carolina. Neither SMI nor Safety Disposal Systems, Inc. has a specific license for
the radioactive material as required by 10 CFR Parts 30 or 32 or from an Agreement State. The basis for this finding was
described in the factual summary of the OI investigation which was sent to you on April 12, 2001. The April 12, 2001 letter
also stated that we were providing you the opportunity to address the apparent violations by either attending a
predecisional enforcement conference or by providing a written response before we made our final enforcement decision. In
a letter dated May 17, 2001, you provided a response to the apparent violations.
As noted in that factual summary, the NRC concluded that the DHS official deliberately classified the radioactive waste as
medical waste and caused it to be sent for incineration despite warnings from several knowledgeable people that classifying
the radioactive material as medical waste was not appropriate. After receiving bids submitted to him for proper disposal,
the DHS official told others that he was over budget from the contamination clean-up and could not afford the high cost of
proper waste disposal. The DHS official also informed an NRC inspector on December 4, 1997, that the drums containing
the broken exit sign and other contaminated objects had been disposed of properly, when, in fact, they had not been
disposed of in accordance with 10 CFR 31.5(c)(8).
As a result of these actions, two violations of NRC requirements occurred, both of which are described in the enclosed
Notice of Violation. The violations involved (1) the deliberate improper disposal of the radioactive material; and (2) the
deliberate submittal of the inaccurate information to the NRC. The safety significance of the violations was low in this case
http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/materials/ea99171 .html 9/29/200
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because there were no doses to individuals or potential doses to individuals that would create a serious health risk, and the
broken exit sign was eventually disposed of properly by SMI. Nonetheless, these violations occurred as a result of the
deliberate actions of the DHS official. Therefore, in accordance with the "General Statement of Policy and Procedure for NRC
Enforcement Actions," (NUREG-1600), the violations are classified as a Severity Level III problem.
In accordance with the Enforcement Policy in effect at the time of the violation, a base civil penalty in the amount
is considered for a Severity Level III problem. Because this was a willful violation, the NRC considered whether credit w?
warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI. i.
of the Enforcement Policy. Credit was not given for Identification since the violation was identified by the State of South
Carolina. Credit was given for Corrective Action since appropriate corrective actions were taken including the proper
disposal of the radioactive material after it was identified by the State of South Carolina.
While the NRC recognizes that application of the normal civil penalty assessment process would result in a base civil penalty
for the Severity Level III problem, I have been authorized, after consultation with the Director, Office of Enforcement, to
exercise discretion in accordance with Section VII. B. 6 of the Enforcement Policy and not issue a penalty. Specifically, you
were issued a $15,000 civil penalty by the State of South Carolina on January 12, 1998, for violations of State requirements
related to this event. Also, you have since removed all exit signs containing radioactive material at your facility, as noted in
your May 17, 2001 letter to the NRC, and therefore, your agency is no longer a general licensee. In light of the above, the
NRC has decided not to issue a civil penalty in this case.
The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken to correct
the violation and prevent recurrence, were already described adequately in your May 17, 2001 letter. Therefore, you are
not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or
your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in
the enclosed Notice.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosures, and your
response will be available electronically for public inspection in the NRC Public Document Room or from the Publically
Available Records (PARS) component of the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site
at http://www^Drc.5oy/reaJing-rm/ad.ajno^ht;mj (the Public Reading Room).
Sincerely,
/RA/ James T. Wiggins Acting for
Hubert J. Miller
Regional Administrator
Docket No. 030-03111
License No. 37-09016-01
Enclosure: Notice of Violation
cc w/encl:
State of New Jersey
State of South Carolina
NOTICE OF VIOLATION
Arthur Brisbane Child Treatment Center Docket No. 030-03111
Farmingdale, New Jersey License No. 37-09016-01
EA 99-171
During an NRC inspection conducted on October 30, 1997, and November 20, 1997, as well as a subsequent investigation
conducted by the NRC Office of Investigation, violations of NRC requirements were identified. In accordance with the
"General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:
A. 10 CFR 31.5(c)(8) requires, in part, that the licensee dispose of generally licensed devices only by transfer to
persons holding a specific license issued pursuant to 10 CFR Parts 30 and 32 or from an Agreement State.
http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/materials/ea99171 .html 9/29/200:
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;: fcA-yy-i /I - Arthur tmsoane cnna ireatmem center rage 3 ot.
Contrary to the above, on December 4, 1997, Arthur Brisbane Child Treatment Center (a general licensee possessing
tritium in EXIT signs) disposed of a broken generally licensed device (containing 12 curies of tritium) and other
objects contaminated with radioactive material, by transferring the material to SMI, East Coast Medical Waste, Inc.
(SMI), 3 company which did not hold a specific license issued pursuant to 10 CFR Parts 30 and 32 or a license from
an Agreement State. In addition, SMI subsequently transferred this material to Safety Disposal Systems, Inc.
(formerly known as Chambers Medical Technologies of South Carolina), which also did not hold a specific license
pursuant to 10 CFR Parts 30 and 32 or a license from an Agreement State.
B. 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee be complete and
accurate in all material respects.
Contrary to the above, on December 4, 1997, the licensee provided the Commission information that was not
complete and accurate in all material respects. Specifically, a licensee official, namely, the Chief of the Bureau of
Environmental Compliance, informed an NRC inspector on December 4, 1997, that drums containing a broken exit
sign and other objects contaminated with tritium, had been disposed of properly, when in fact, the material had not
been disposed of in accordance with 10 CFR 31.5(c)(8). The material was not disposed of in accordance with
10 CFR 31.5(c)(8), in that it was transferred to SMI, a company which did not hold a specific license issued pursuant
to 10 CFR Parts 30 and 32 or a license from an Agreement State. This information was material because it had the
capability to influence the NRC follow-up review of the disposal.
This is a Severity Level III problem (Supplement VII).
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to
correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately
addressed on the docket in the referenced inspection report and in your reply to the NRC dated May 17, 2001. However,
you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not
accurately reflect your corrective actions or your position. In that case, or if you choose to respond, you should clearly mark
your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission,
ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regjonal Administrator, Region I, within 30 days
of the date of the letter transmitting this Notice of Violation (Notice).
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to
the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
If you choose to respond, your response will be made available electronically for public inspection in the NRC Public
Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is
accessible from the NRC Web site at http://www.nrc.gov/readinq-rm/adams.html (the Public Electronic Reading Room).
Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards
information so that it can be made available to the Public without redaction.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 16th day of August 2001
http://www.nrc.gov/reading-rrnydoc-coilections/enforcement/actions/rnaterials/ea99171.html 9/29/200.
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Pa
Faxback 11606
9455.1991(02)
OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE
MAY 16 1991
Mark J. Schulz
President
Pharmaceutical Services, Inc.
Browning-Ferris Industries
757 N. Eldridge
Houston, Texas 77079
Dear Mr. Schulz:
This responds to your February 22, 1991 letter to David Bussard 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. Currently, such products are returned directly to the manufacturer
or wholesaler, who credits the dispenser for the products and determines
whether the products are to be reused, reclaimed, or appropriately disposed.
BFI Pharmaceutical Services, Inc. (BFI-Pharm) intends to provide this reverse
distribution service to the pharmaceutical industry.
As I understand your letter, pharmaceutical products may be returned for many
reasons, including, among others: 1) an oversupply at the dispenser, 2)
expiration of the recommended shelf life, 3) a recall has been initiated by
the manufacturer, 4) the product was received as a result of a shipping
error, and 5) the product has been damaged. You state that, in general the
dispensers of the pharmaceutical products do not know whether the returned
products will be reused, reclaimed, sold overseas, or disposed (i.e, they are
not able to determine whether these materials are solid wastes). Because the
dispensers receive credit for the returned products (either because the
products actually have real value to manufacturer or because such credits are
part of a competitive marketing approach), the products have a monetary value
to the dispensers and they would not normally assume such materials to be
wastes.
Under our current regulations, such returned products are not considered
solid wastes until a determination is made to discard these materials. The
returned products themselves (being "commercial chemical products" under our
classification system) are considered more product-like than waste-like
(until a determination is made to dispose of them) because recycling by
use/reuse is generally a viable option. If the underlying assumption is that
the returned products will be recycled, until the manufacturer or wholesaler
determines otherwise (assuming that this determination is beyond the ability
of the dispenser), then those products managed within the reverse
distribution system are not solid wastes until the manufacturer or wholesaler
makes the determination to dispose of them. This view is based on our
understanding that the system is established as a means to facilitate the
recycling of reusable pharmaceutical products, rather than a
waste management system. We will be interested to learn if your data, which
will be computerized, will support this assumption. At the current time
there does not appear to be any reason for EPA to change its policy regarding
this type of reverse distribution system simply because a third-party service
company is involved rather than the manufacturers themselves.
I would like briefly to bring to your attention two issues that bear
generally upon reverse distribution systems, although neither appear to be of
concern in the BFI-Pharm situation. First, EPA does not intend for hazardous
waste brokers to use a reverse distribution system to relieve generators of
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the responsibility for making determinations about the discarding of
materials as wastes. It remains the generator's responsibility to properly
identify secondary materials. Second, a reverse distribution system cannot
be used as a waste management service to customers/generators without the
applicable regulatory controls on waste management being in place. Of
course, as I discussed above with respect to the BFI-Pharm situation, to the
extent that the materials involved are unused commercial products with a
reasonable expectation of being recycled in some way when returned, the
materials are not considered as wastes until a determination has been made to
discard then.
This interpretation is based on the current set of Federal RCRA regulations.
However, as you know, authorized States may regulate or interpret the
regulations differently, and State requirements are the applicable standards
in authorized States. You should contact the appropriate State regulatory
agencies for a more definitive regulatory detenuination for their respective
jurisdictions.
I hope this has sufficiently answered your questions. Should you have any
further questions regarding EPA's policies, you may contact David Bussard at
(202) 382-4637.
Sincerely,
Original Document signed
Sylvia K. Low ranee
Director
Office of Solid Waste
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Faxback 12996
9444.1987(37a)
RCRA/Superfund/OUST Hotline Monthly Report Question
August 1985
8. Definition of Solid Waste and Reclamation
A distributor of a U-listed commercial chemical product
finds that the product is no longer saleable (for
example, it is past its shelf life). If the distributor
ships it back to the manufacturer for reclamation, the
material is not a solid waste under 40 CFR 261.2 because
listed commercial chemical products are not solid wastes
when reclaimed. However, in many cases the manufacturer
will not know whether the material can be reclaimed until
a sample is analyzed. Could the distributor ship the
entire lot back to the manufacturer, while not knowing
whether the material was a solid waste?
Yes. The distributor can ship the entire lot back to the
manufacturer, while not knowing whether the material was a solid
waste. There are no provisions in the RCRA regulations restricting
shipments of commercial chemical products. Technically, it remains
a commercial chemical product until such time as they are discarded
or intended to be discarded (Section 261.2 and Section 261.33).
This decision is made by the manufacturer. The U-listed commercial
chemical product would still be shipped pursuant to applicable DOT
and U.S. Postal Service regulations. It would not need to be
manifested as a hazardous waste.
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9443.1989(08:
>*
'i - UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
3 WASHINGTON. D.C. 20460
AU3 j 1 !989
SOL 0 waS'E AND €W£SGeSO "S'f
MEMORANDUM
SUBJECT: Clarification of RCRA Authorities Regarding U.S. Army
Corps of Engineers DredgeyiSadiments
FROM: Sylvia K. Lowrance, Direc^dr l
Office of Solid Waste
TO: Basil G. Constantelos, Director
Waste Management Division
Region V
This memorandum responds to your May 30, 1989, request for
clarification concemiiicj RCRA authorities to regulate dredged x
sediments that exhibit one of more characteristics of a
hazardous waste. As yoo. steted, EPA's policy regarding such
materials is defined In the January 23, 1986, memorandum from
Marcia Williams to David Stringham. However, the U.S. Army
Corps of Engineers (USACOE) published a Federal Register
notice on April 26, 1988 (53 FR 14902), in which USACOE
concluded that dredged materials are not solid waste and,
therefore, not subject to RCRA. These contradictory statutory
interpretations and policies have caused confusion in properly
implementing RCRA authorities over dredged sediments.
The Agency's policy regarding the applicability of RCRA to
dredged sediments remains unchanged from the January 23, 1986,
memorandum. The pertinent points of this policy are: 1) point
source discharges subject to Section 402 of the Clean Water Act
(CWA) are exempt from RCRA, 2) hazardous wastes dumped into
surface water in a manner that does not trigger Section 402 of
the CWA are subject to RCRA regulation, as veil as any sediments
that are contaminated by such discharges (under the contained-in
rule), and 3) in eases where the pollutants discharged into
surface water are not subject to RCRA, sediments would be
regulated under Subtitle C of RCRA flnly. when they are dredged
from the surface waters and flnlv. if they exhibit one or more
characteristics of hazardous wastes.
The Office of Solid Waste and the Office of General Counsel
are currently evaluating the best approach to take in addressing
USACOE's April 26, 19«t, Federal Register notice. I agree
that a definitive statement of RCRA authorities over dredge
sediments is needed to clarify the regulatory requirements.
Thank you for bringing this issue to our attention. Should
you have any questions, your staff should contact Mitch Kidweii,
of my staff, at FTS 475-8551.
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RCRA/SUPERFUND HOTLINE MONTHLY SUMMARY
JANUARY 89
1. Ore and Mineral Extraction. Beneficiation and Processing Exclusion
Applicability
The owner /opera tor of a taconite ore mining and processing facility uses several
different processes to increase the taconite ore's concentration. These processes
include a grinding and magnetic separation process that constitutes benefi elation.
This beneficiation process incorporates the use of Whirmore grease for
mechanical lubrication. The Whitmore grease is removed once every ten years
and is sent for disposal. Is this grease, which exhibits the characteristic of EP
toxicity, exempt from being a hazardous waste pursuant to 40 CFR Section 261 4
In the November 19, 1980 Federal Register (45 FR 76620), the EPA
promulgated regulations excluding solid waste from the extraction.
benefication, and processing of ores and minerals from the definition of
hazardous waste. The preamble to this Federal Register stated this exclusion
applied to wastes produced in, and unique to the exploration, mining,
milling, smelting and refining of ores and minerals. The exclusion did not
apply to solid wastes, such as spent solvents, pesticide wastes, and discarded
commercial chemical products, that were not unique to the mining and
processing operations (45 ££.76619).
Since 1960, common mining and processing operations have included the
long-term application of Whitmore grease to heavily used machinery, gears
and other difficult to access equipment. However, Whitmore grease is not
limited to the mining industry, but can be used on any industrial equipment
where short term grease applications are limited by difficult access and heavy
use. Therefore, because the Whitmore grease is not unique to mining
operations, it is not excluded pursuant to 40 CFR Section 261.4 Cb)(7). The
grease that can no longer be used for its intended purpose and mat is going for
disposal would be a solid waste pursuant to 40 CFR Section 261.1 (cKl) and 40
CFR Section 261.2, respectively (see January 4, 1985 Efidenl Bfiiiiiil (50 ££
663)]. This solid waste will be a hazardous waste if it meets a listing under 40
CFR Part 261 Subpart D or exhibits any characteristic under 40 CFR Part 261
Subpart C.
Source: Bob Hall (202)475-8814
Research: Jace Cuje (202) 382-3000
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9444.1988(14)
i - UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
| ^^^7 5 WASHINGTON. D.C. 20460
souo WASTE AND
MEMORANDUM
SUBJECT: Guidance for Secondary Lead/Smelter Variances
' //i-ll > T
FROM: Sylvia K. Lowranc£,_ -' -/L-'- ^—"-
Office of Solid Was"
TO: Waste Management
Division Directors, Regions I-X
This memorandum provides guidance to assist you in handling
variance requests you may receive from secondary lead smelters.
Owners and operators of secondary lead smelters are likely to
request variances from being classified as a solid waste for
their lead plates and groups that are stored in storage piles.
More detailed information is included in the attached report
from Midwest Research Institute. Questions in this area should
be addressed to Filomena Chau or Mike Petruska at FTS 382-4795
or 475-8551.
A. General.
Section 260.30(c) provides that the Regional Administrator
may grant a variance from classification as a solid waste for
those materials that have been reclaimed but must be reclaimed
further before recovery is completed if, after initial
reclamation, the resulting material is "commodity-like." This
determination is to be based on five factors specified at
Section 260.31(c)(l)-(5), and "other relevant factors"
(paragraph (c)(6)).
Secondary lead smelters reclaim lead from spent lead acid
batteries (a characteristic hazardous waste). An intermediate
step in this reclamation process is the breaking and component
separation of batteries, which results in partially-reclaimed
lead-bearing material known as "plates" and "groups." These
materials may be stored in piles and subsequently fed to blast
or reverberatory furnaces for re-smelting. Under certain
conditions, these plates and groups may meet the criteria in
Section 260.31(c) and, therefore, would not be a solid or
hazardous waste. ^
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In some instances, the granting of a variance'for plates and
groups could lead to a smelter becoming exempt from the need to
comply with the interim status requirements or obtain a permit.
For example, if a smelter can set up an operation where incoming
batteries are introduced directly into the recycling operation
without prior storage, and where emission control dust (K069) is
recycled either without storage or stored under Section 262.34,
the smelter would have no activities subject to permitting
(absent the plate and group storage pile).
B. Factors 1-4.
After analysis of a considerable body of information, OSW
has determined that secondary lead smelters on a national (or
"generic") basis meet the criteria of Section 260.31(c)(l)-(4).
The basis for this determination is summarized below. - (For more
details, see the attached draft report from Midwest Research
Institute (MRI).)
o The first factor (paragraph (c)(D) is the degree of
processing a material has undergone and the degree of
further processing that is required (for the resulting
material to be "commodity-like"). Available
information indicates that the battery-breaking and
component separation steps can be labor-intensive and
often represent a significant percentage of the
resources required to recycle a battery; we would view
these steps, then, to account for a substantial amount
of processing.
o The second factor (paragraph (c)(2J) is the value of
the material after initial reclamation. We have
determined that plates and groups do have significant
market value, i.e.. prices for plates and groups are
listed in industry publications, and until recently
smelters have purchased*large amounts of plates and
groups from independent battery breakers.
o The third factor (paragraph (c)(3)) is the degree to
which the reclaimed material is like an analagous raw
material. He have determined that plates and groups
are similar to galena ore in terms of lead
concentration, and based on available data do not
contain significant amounts of hazardous constituents.
not found in galena. (Arsenic concentrations do appear
- to be slightly higher in the plates and groups, but we
note that small amounts-of arsenic are viewed as
desirable in secondary lead smelting as an alloying
metal; therefore, our determination is that
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the slightly higher arsenic concentrations in lead
plates and .groups do not change the conclusion that it
is substantially comparable in composition to galena
ore. }
o The fourth factor (paragraph (c)(4)) is the extent to
which an end market for the reclaimed material is
guaranteed. Typically, .secondary lead smelters break
and separate batteries at the smelter site. This
arrangement provides an end market for the partially
reclaimed material because it is unlikely a smelter
would close without processing remaining plates and
groups. We do not, however, reach such a conclusion
for independent battery breakers. The end market value
for their broken batteries is heavily dependent on lead
prices, and has been very insecure for the past several
years.
C. Storage and Handling Practices.
Section 260.31(c)(5) identifies as a factor, "the
extent to which the reclaimed material is handled to minimize
loss." OSW reviewed information on plate and group storage and
handling practices at most secondary lead smelters in the U.S.
We are unable to reach any conclusions on a national basis for
this industry because the available information indicates a wide
variation in practices (i.e., some smelters store the lead
plates and groups in a manner that minimizes loss while others
do not). Each smelter facility will hive to be evaluated
individually to determine if the standard in paragraph (c)(5) is
achieved. Factors that Regional (or State) personnel may want
to consider include:
o Whether the storage pile is under a roof;
o Whether the pile is on an impervious base, e.g., coated
concrete;
o Whether runoff controls are in place, e.g., retaining
walls, drainage collection, etc.;
o whether wind dispersion controls, e.g., sprinklers,
vents, etc., are in place.
Plate and group piles may be evaluated in a manner similar to
those hazardous waste piles considered for the limited exemption
under 40 CFR Section 264.250(c), which calls for consideration
of these same sorts of factors.
-------
Also relevant is a comparison of storage and handling
practices at the secondary lead smelters to handling practices
employed by primary lead shelters for galena ore. Available
information indicates that galena ore is always stored under
cover, but galena storage areas are not always totally
enclosed. Therefore, some outdoor plate and group storaae areas
may meet the paragraph (c)(5) factor without being enclosed in a
building, but a plate and group pile without any cover would
appear much less likely to satisfy the "minimize loss"
criterion.
Finally, while concrete pads are the norm for plate and
c.oup storage areas, typically the top layers of these pads
(which may be an asphalt liner) become damaged by the acid
remaining on the plates and groups, and by front-end loader
traffic and, therefore, have to be periodically replaced.
Normal maintenance of a plate and group pad includes periodic
replacement of the top (i.e. , "sacrificial") layers. Therefore,
part of the paragraph (c)(5) evaluation should include a review
of the smelter's pad replacement schedule. Consideration should
be given to requirements for coating the concrete pads with an
acid resistent material.
In summary, a plate and group pile that is stored under
cover, where run off and wind disposal is controlled, and where
pad replacement prevents soil contamination, would appear to
meet the paragraph (c)(5) "minimize loss" criterion.
D. other Relevant Factors.
*
Under Section 260.31(c)(6), the Regional Administrator
may consider other relevant factors in the determination of
whether to grant the variance. These factors may be raised by
the petitioner, the Agency, or other interested parties. As OSW
has evaluated information on secondary lead smelters, the
following additional factors have been raised as potential
concerns. Although these factors, may not be directly applicable
to the Regional Administrator's decision to grant a variance,
they may be relevant in, for example, assigning priorities to
evaluate a facility's petition.
1. Economics of battery recycling. Recent EPA studies
indicate that national battery recycling rates, while apparently
stable at this time, have experienced a long term decline over
the past 30 years. The result is that more batteries are
disposed of, often in municipal landfills. In addition, loss of
recycling capacity (i.e., smelter closures) has placed
generators in some* regions (e.q.* the Pacific Northwest) in the
position where they must transport batteries long distances to
recycle. This obviously adversely affects recycling rates.
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- 5 -
Environmental compliance costs may be a major component of a
secondary smelter's capital and operating expenses. The next
few years may be critical for many of these smelters, as they
face the choice of full RCRA compliance and permitting versus
facility closure. Prompt processing of variance petitions may
allow well-run operations, for example, to expand operations
without the need for a permit modification (or perhaps without a
permit at all), and thereby maintain or increase regional
recycling rates, even if other facilities close.
2. Corrective action. Facilities in the secondary lead
smelting industry have had problems in the past and some are
currently involved in clean-up activities. One implication of.
granting a variance is that certain facilities, as noted above,
may become exempt from permitting and interim status
requirements and, therefore, the corrective action provisions of
RCRA Section 3004(u) and 3008(h) would no longer apply. (CERCLA
Section 106 and RCRA Section 7003 actions would not be affected
by granting the variance.) The Regional Administrator may want
to consider the need for clean-up at a site under paragraph
(c}(6), or at least in the timing of when a variance is
granted. For example, final granting of a variance could be
considered as part of clean-up action at the facility.
In summary, disposal of spent lead-acid batteries is
becoming a serious national problem. One means to increase
battery recycling rates is to exclude plate and group storage
piles at those secondary lead smelter facilities that meet the
Section 260.31(c) criteria from classification as solid waste.
If a secondary lead smelter facility stores and handles its
plates and groups in a manner that minimizes losses and
otherwise runs a sound operation (as evidenced by, for example,
clean-up of past releases), OSW would deem it appropriate and
certainly consistent with national policy for the Regional
Administrator to grant the solid waste variance.
«
Attachment
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20480
JUN ' 6 BS8 .
SOLID WASTE AND EMEBGENO'
}
James K. Petros
Union Carbide Corporation
39 Old Ridgebury Road
Danbury, CT 06817-0001
Dear Mr. Petros:
This is in response to your letter of March 3, 1987,* in
which you requested clarification of the domestic sewage
exclusion (DSE) which is set forth at 40 CFR 261.4(a)(1). in
particular, you requested clarification on the following issues:
o Does the DSE apply to mixtures of industrial waste and
sanitary waste generated at a facility?
o Must the sewer line in which mixing occurs be owned by the
POTW for the DSE to apply?
o Does the DSE apply when mixing occurs within the property
boundary of the POTW?
In the preamble to the May 19, 1980 regulations, EPA set
forth the rationale for the DSE. The exclusion states that a
mixture of domestic waste with industrial waste is covered by
the exclusion. The exclusion is not based on health or
environmental considerations but rather congressional intent.
The rationale for the exclusion was that mixed waste streams
that pass through sever systems to POTWs will be subject to
controls under the Clean Water Act (CWA). The Agency's
pretreatment program provides a regulatory basis for EPA and
local communities to control the introduction of wastes into
sewage treatment systems that may present environmental
problems.
While the letter vas dated March 3, 1987, we assume you
meant March 3, 1988, since we did not receive the letter
until March of 1988.
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- 2 -
You asked for clarification on whether the DSE applies to
mixtures of industrial waste and sanitary waste generated at an
industrial facility. The answer is no; the DSE applies only
when an industrial waste enters the public sewer system in which
it will be mixed with untreated sanitary waste generated from a
non-industrial source (i.e., sewage from a domestic source). .A
discharge from an industrial facility, even when it is mixed
with sanitary waste is still an industrial discharge. The sewer
line in which mixing occurs must be publicly owned in order for
the DSE to apply.
In order to qualify for the exclusion, the 1980 preamble
states that mixing must occur prior to treatment and storage at
the POTW. The POTW boundary is a reasonable interpretation of
when treatment and storage commences. In the July 15, 1985
final rule (50 FR 28702) which codified the Hazardous and Solid
Wastes Amendments (HSWA), EPA distinguished between those POTW»s
requiring a RCRA permit by rule and those for which none is
required. As stated in the rule, a RCRA permit is required for
hazardous wastes which arrive at a POTW by truclc, rail, or pipe
that do not carry domestic sewage. Implicit in this definition
is that a pipe from an industrial user, when connected inside
the POTW property boundary is a dedicated pipe and the POTW
would therefore require a RCRA permit if the waste is hazardous.
I believe this answers all of your questions. Any further
questions on this issue should be directed to Paul Connor in the
Office of Water Enforcement and Permits at 475-7718.
Sincerely,
Sylvia K. Lowrance, Director
Office of Solid Waste
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9441.1937(96)
UNITED STATES ENVIRONMENTAL PROTECTION AC
WASHINGTON O C 204«0
Cf= C£ ;<
DEC I 0 887
Eric J. Dougherty
8409 H. Morven Road
Parkville, MD 21234
Dear Mr. Dougherty:
This is in response to your November 13, 1987 letter to
Robert Scarberry concerning land disposal of solvents. The answer
to your questions are as follows.
First, you are correct that industrial wastewater discharges
subject to the Clean Water Act (CWA) are excluded from the hazard-
ous waste regulations, and it does not matter how the wastewater
was generated. You should note, however, that only the discharge
is excluded. If hazardous wastewaters are collected, stored,
treated, or disposed of prior to discharge, this prior management
is subject to the hazardous waste regulations (including the land
disposal restrictions of 40 CFR Part 268).
Second, EPA does not have groundwater discharge guidelines
per se. Facilities that have RCRA interim status or that seek a
RCRA hazardous waste facility permit are subject to a number of
requirements designed to protect groundwater in 40 CFR Parts 264,
265, 266 and 268, as veil as the corrective action provisions of
RCRA Sections 3004(u) and 3008(h). Facilities that generate
hazardous waste but which ar« exempt from interim status and
permitting requirements under the accumulation provisions of 40 CF
Section 262.34 (this is likely the case for the automotive mainten
ance facilities you asked about) are subject to container and tank
management standards designed to prevent releases to groundwater.
When releases do occur, EPA or the appropriate State agency can
take enforcement action under RCRA Sections 3008(a) and 7003 to
require the facility owner or operator to stop the discharge and t
clean-up contaminated soil and groundwater.
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If you have further questions in this area, please c
Micnaei Petruska at 9202) 475-8551.
Sincerely,
Marcia E. Williams
Director ,
Office of Solid Waste
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9441.1937C9)
OCT I 5 —
Mr. Bernhardt C. Warren, CHMM
Manager, Institutional Waste
Quadrex HPS Inc.
1940 N.w. 67th Place
Gainesville, Florida 32606-1649
Dear Mr. Warren:
Thank you for your September 22, 1987, letter in which you
raised a number of issues regarding management and treatment of
scintillation media.
In the July 3, 1987, Federal Register Notice, the
Environmental Protection Agency (EPA) clarified its position
that mixed wastes are subject to hazardous waste regulations.
Since that Notice was published, EPA and the Nuclear Regulatory
Commission (NRC) have worked to minimize the impact of dual
regulation of mixed waste on the regulated community. Further,
I recognize that the clarification of Resource Conservation and
Recovery Act (RCRA) applicability to mixed waste has broadened
the scope of wastes now subject to RCRA regulations. Hazardous
waste regulations may now encompass generators, treaters, and
other handlers of radioactive wastes that may not have been
subject to RCRA previously.
The EPA position regarding mixed waste has been and
continues to be that, if a hazardous waste is combined with a
radioactive waste, the hazardous waste must be managed in
accordance with applicable RCRA regulations. Consequently,
organic solvent containing scintillation media would be subject
to RCRA independent of a NRC designation as below regulatory
concern for the radioactive constituent. The example you
described in your letter, however, points out that generators
and owner/operators of treatment facilities may 1) be knowingly
mismanaging scintillation media in an effort to circumvent
applicable NRC regulations; or 2) lack the technical expertise
to determine if, in fact, the level of radioactivity in the
scintillation media is below regulatory concern.
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EPA and NRC do not. consider mismanagement of mixed
waste or violation of applicable regulations to be a result of
conflict or inconsistency in the regulations. Rather, both
Agencies believe that stricter enforcement of applicable
regulationswould avert such situations. At this time, however,
it does not appear that promulgation of regulations specific to
mixed waste is appropriate.
I appreciate your bringing this potential violation to the
attention of the responsible Agencies. My staff has discussed
the issues raised in your letter with the NRC and they are
currently investigating the allegations. In addition, I referred
your letter to our Enforcement Division for review although
compliance with applicable NRC regulations appears to be the
basis for your concern. NRC has indicated that, once their
review of the issues you raised is completed, you will be
apprised of their findings. Again, thanJc you for bringing this
situation to my attention.
If I can be of any further assistance, please let me know.
Sincerely,
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RCRA/SUPERFUND HOTLINE MONTHLY SUMMARY
OCTOBER 87
5 - Applicabilit
v
Exeiuai_
Hazardous industrial wastewaters
Clean *at*r Act under a XPDES
regulation unoer RCFU
fron the outfall to^a"
v-astewater is ased in f
L th. status of -n
re
S>y the
'-J frcn
not fall
define, "
the RCRA
of oU
«.a«teMter Jo
«
Source: Randy Hill
Research: Laurie Huber
(20:, 38J-77QO
-3-
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JUN 2 6 I98T
"*r. Terry
Chair. Northwest Interstate
Coranact Committee
v.a*nincton Department of Leo Ion v
PV-11
Olynria- '•i
L>ear Mr. -i
Than* you ^or vour letter of "«v 28 in which you
guidance on treatment and disposal "»ethods for low-level waste
that contains urcontaninat^d lead used as shieldinn. surface
contaminated lead and activated lead.
First, I would like to address activated or radioactive
lead. As you know, lead is not a naturally occurring radionuclidc
Lead «av hecone radioactive or activated *s a result ot neutron
oo'ibardjwent wnile betnn used as shleldim In nuclear cower nlarts,
for example. Such activated l*ad, if st'-^rt- lived , n»ay be .«ror*-t
to allow radioactive decay rrior to <3is>--*al. I^e resultant
ron-act ivat*^ or slenental lead may £e c'iricos^d of as hazardous
wast* in a hazardous waste disposal facility. I* storaqe for
Jecay i* i^t-ract ical . the activated le*<* -iust he man^ne.'* as
-uxed wast*. You should not*, however, that in States authorizes
t2 a^^inister the Federal mixed waste rri^r*^ or in states with
Pe-lerallv adrinistcrad hazardous waste pronra-t«, anv stor«c;e nt
-ixe.^ w-^^tt in excess of ninety days 'or "ererators ^nd t»r» days
tor transfer facilities would require * P«»«ourc«» Conservation
«jno recovery *ct (PCRA) o«rmit. Sint
facilities nust obtain a RCRA permit.
Lead which is contaminated on the sur^.jce ^.av ho deconta">inai
by a number of cornea re i ally av^ilaMa processes, however. hecau««
ieid is malleable and *asilv qouied or pitten, radioactive corf a--
i nation is often not limited to th« surface *n«3 nay be i-nnetrt^c i
the lead itself, t-'here -lecontari nation is inco-ol*te or cortrair
dicatad because of occur ational health considerations, the leao
^ust h* man*o«d as a r»ixed w**te. Also, Li»A's cffic* of -s.M^cif
Proaran* i« develooing a standard which will d»iin**te levels
of radiation which ar« K«-low r*»nuiatorv concern (ce>C). f-rc« :<"C
levels have heen estaollsned/ it way he ry»s«sihle to Jisrose cr
lead which «xhir,its ^^r l»vr»l^ of ra'Uoacf i v«» cont?-'i raticr- «« a
hazardous waste.
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&••« •o-*aliwr. •«. «»».t— r 11*.,, wftle* are use* •• efcieldisq
i« iov-j«*»«l »••«• dlapo»«i «p*r«ei«m« poee * unicue problem. Con-
tainers or container linere ere noc r*gui«x*d by the Agency (See
40 CFR 261.7) nor would they oe « waste because they «r« ^ulfl.lirw
intended uses. ( (CF 40 C?R 26i.2(c)( l)(ii) ). In this instance,
containers or liners *av be anaioa^us to co-»r*ccial cf«v-ici! product*
(e.g., pesticides) where as a Drortuct , their normal us* is ;->l4c*ner-t
on the land. Therefore, lea.-l whose nrl^.ary us*» i^ bhielilnc in
low-level waste disposal operations is not sub 1 act to t*o«ral
haiardou» wast« regulations when nlaced on th» larnl a? riart o,f lt»
no real commercial use.
Pncaosulat ion rerresents ^ viable wechanimn for rit irat inn
the haiardous waste characteristic lead may exhibit upon rP toxi-
city testlna only in specific circumstances. The EP toxicitv test
procedure requires grinding the waste into nieces not greater than
or* square c-nti^*»ter in wise prior to extraction. Therefor*.
encapsulation would result in a non-haiardous waste only in those
in^t^nces where it could fee Demonstrated that the encapsulation
process results in a oroduct that would not degrade after dispo««l,
(i.e., is resistant to degradation r»r fracturino when placed in th«
land disposal •nvironwent ) . In such instances, you could petition
the Agency to waive ,the EP toxicity t*st reoui recent. Additionally.
the Aqancy is revising existing EP toxicity test procedures,
is underway to develon procedures for evaluating a waste's long ten
physical stability. These procedures *ay then be used demonstrate
that the encapsulated material will not degrade and allow testing
of an intact lead brick or the like, for exwpl*.
The Agency ha* not evaluate-! specific t«.<-'t no lories for
encapsulation of lead or other wastes* nor his the Agency performed
specific laboratory analyses of materials to -eterain* their resis-
tance to .the EP toxicity test. However, a polymer or some other
waterial which maintains its integrity under f nv i ro nse nt a 1 stress
would seem to be suitable.
Zn view of the urgency of the lead issue, it »ay be prudent
to explore the feasibility of obtaining both a fcuclaar Regulatory
Cowsiission license and an CPA nemit to provide for the '1i«ir>o«al
of e,ixed waste.
If X can be of further assistance, do not **sit*te fo contact
Sincerely vours.
E.
Of tic* of
'-.il lisas. Director
Soli<* wast*
cc; Alan Cor son
Floy* Galpin
Ken Shuster
bcc: Jim Michael
Betty Shackleford
-------
JUN I 0 !98T
Ms. Beverly Brookshire, Staff Architect
Building and Service Section
Federal Deposit Insurance Corporation
Washington. DC 20429
Dear MS. Brook shi re i
This is in response to your letter of Hay 21, 1967. The
answers to your specific questions are as follows i
(1) You will have to contact the District of Columbia
to find out if the darkroom drains to a publicly-
owned treatment works (POTW), i.e., the Slue Plains
Facility.
(2) If the darkroom does drain (along with domestic
sewage, i.e., untreated sanitary wastes) to a POT*,
then the photo chemicals are not solid waste, and not
hazardous waste. See 40 CFR $261. 4 (a)(l).
If you have further questions, please contact Mike Petruska
of my staff at 382-4765.
Sincerely,
Harcia Nillians
Director
Office of Solid waste
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ' ,, ,,,,,.,
944j..i3o (40)
MAY 2 I 1987
Honorable Phil Gramm
United States Senate
Washington, O.C. 20510
Dear Senator Gram&s
Thank you for your March 26, 1987, letter regarding your
constituent's concern with the mixture rule as it applies to
al activities.
Federal activities
First, you should know that the Environment*! Protection
Agency (EPA) modified its hazardous waste regulations in
Hoveaber, 1981 to exempt certain wastewater /sol vent mixtures
that contained low levels of solvents (see enclosure). These
rules actually relieved many industrial wastewater treatnent
facilities from having to comply with the hazardous waste
regulations. EPA set the concentration limits based on the
conclusion that wastewaters meeting the limits would not pose
a threat to human health or the environment. Conversely,
wastewaters exceeding the limits may pose a threat, and
therefore, remain subject to regulation. You should note,
however, that even wastewaters exceeding the limits, when
treated in t&nkc, are. exempt from regulation.
In promulgating this rule, EPA is not treating Federal
facilities any differently than other industrial wastewater
treatment facilities. Thus, if any Federal facility, including
the Naval Air Rework facility at Pensacola, Florida meets the
limits set in the regulation, the wastewaters would not be
hazardous due to their solvent content. You should be aware
that the wastewater treatment units at the Psnsacola facility
contain other hazardous waste; thus, they would be subject to
regulation under the hazardous waste regulations.
-------
Your constituent also raises the possibility that an
inequity aay exist in how EPA regulates publicly owned and
privately owned treatment works (privately owned treataent
works encoapass industrial wastewater treatment facilities,
including those that exist at Federal facilities). The
difference in regulation is not due to the Federal government's
ability to pay, but instead is the result of a statutory
mandate in RCRA Section 1004(27). The statute excludes solid
or dissolved material in industrial discharges which are
subject to peraits under Section 402 of the Federal Water
Pollution Control Act.
If I can be of any further assistance, please contact
ae.
Sincerely,
Winston Porter
Assistant Adainistrator
Rnclocure
-------
9441.1936(88)
J True* or R ail Shipment of Hsjpardous Was tee to a PQTV
iT y ill/
FP.CH: Marcia Williams, 0 i rector \L\ \r.»d I \\
Office of Solid Wast* $VlF*v
TO: n*vid A. 3trin«ha», Chief
Solid Waste ?ranch, Region V
This ae«o is a follow-up response to your September 3, 1986,
request for clarification of the POTV exclusion in 40 C?R
As noted in my memorandum to you of September 25, 1986, the
POTV exclusion in lioited to the circumstances and conditions
of $261.4(a)(1)(ii). Thus, a material is not a solid waste
if it is "Any ir.ixture of domestic sewage and other wastes that
masses through a sever STB tea to a publicly-owned treatment
vorics for treatment (emphasis added)." If the material does
not riass through a sewer system prior to arriving at a POTW,
it is deemed to be a solid waste and, if appropriate, a
fcmeardous waste. Consequently, POTVs that nanaae wastes
which h*ve not passed throu«h the sewer system %nd nixed with
donea tic sewaae would be subject to all applicable hazardous
waste regulations. ^Tnder §270.50(c), the POTW would be
the dichotoiay vhich regulating a eaterial
on the basis of its mode of conveyance (i.e., by truck or
newer) appears to present. This situation was discussed in the
Agency's "February 1986 Report to Congress on the Discharge of
Wastes to Publicly Owned Treatment Works (Domestic
-------
-2-
Seva^e Studr; P*. <»-fl5). However, at present this implies that
7,?k cotild exempt trucked or railed waste without a statutory
chang* - highly dubioa legally. Wut«e which are shipped to
?C?Vs by truele, rail, or dedicated pi
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RCRA/SUPERFUND HOTLINE MONTHLY SUMKARY
JULY 86
4. Mining Waste, K064, and §3004(x)
EPA published a prooosed rule in the October 2, 1985 Federal Register
(50 FR 40292). The proposed rule would reinteroret the minim waste
exclusion at 40 CFR 261.4(b)(7) as it aoplies to orocessing wastes.
Only large volume, relatively low toxicity orocessing wastes would
be excluded, soecifically ohosogypsum, bauxite refining muds,
primary metal smelting slags, and slag from elemental Dhosphorus
reduction. The reinteroretation also prooosed to relist six smelting
wastes previously listed as hazardous. One of the six smelting
wastes prooosed to be relisted is K064, acid plant blowdown slurry/
sludqe resulting form the thickening of blowdown slurry form orimarv
copper production.
If EPA finalizes the listing of K064, can EPA modify existing Subtitle
C requirements under Section 3004(x) of *CRA for units handling K064?
Section 3004(x) authoriizes EPA to modify existing Subtitle C recuire-
ments to take into account the special characteristics of mining
wastes, the oractical difficulties associated with implementation of
such requirements, and site-specific characteristics.
Only large volume, relatively low toxicity processing wastes would
be excluded, soecificallv, phosohogvDSum, bauxite refining muds,
primary metal smelting slags, and slag from elemental nhosnhorus
reduction. The reinteroretation also orooosed to relist six smeltina
wastes previously listed as hazardous. One of the six smelting
wastes prooosed to be relisted is K064, acid plant blowdown slurry/
sludge resulting from the thickening of blowdown slurry from primary
copoer production.
If EPA finalizes the listing of K064, can EPA modify existing Subtitle
C requirements under S3004(x) of HCRA for units handling K064? Section
3004(x) authorizes EPA to modify existing Subtitle C requirements to
take into account the soecial characteristics of mining wastes, the
practical difficulties associated with implementation of such require-
ments, and site-specific characteristics.
Mo; S3004(x) authority would not aooly to K064. Section 3004(x)
authority only applies to wastes temporarily excluded under $3001 (b)
(3)(A)(ii) (the "Bevill Amendment"), i.e., solid waste from
the extraction, beneficiation, and processing of ores and
minerals, that subsequently become subject to Subtitle C of
RCRA based on the results of a $8002 study. If finalized, the
proposed reinterpretation would narrow the scone of the "Bevill
Amendment." Wastes that are no longer encompassed by the
exclusion, including this primary copper smelting waste (if
listed in the final rule), would not be mining wastes (solid
wastes from the extraction, beneficiation, and orocessing of
ores and minerals). Therefore 53004(x) would not apply.
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9432.1986(10
w-J^Jf.CT: definition ot Byproduct "aterial
F.tCX: Farcia L. V.illiafrs, director Crisis*1 Si§n«* able to judn« wnich waste it reams at any LOK facility
sftouin o*» regulated is to -work directlv with the facility to
rako case-bycase uecisions based on the ASA definition.
-------
- 2 -
EPA considers all mixtd waste- *tri.«ima to j*e «u:;>-ct
c- r-%^ral regulation uncer RCRA. w«j woui'1 ^-x'pct that wt^ita*
wi.tn the jaae radioactive waste exemption aa tPA would also
.i-.t;. jv".o all nixa'J wastes in their rc'julatoiy univ«srs«. ::uwvv..r.
-r.til th#» Statas are authorized lor nixed wastes, it IB ^oiSiiit
w..wc v..eir interpretations of tiieir statutes nay -In J< r .r
.on c*
7"ae savannah Rivar Plant should provide to tha Dtat« ot
^o-t.i Carolina a i>*r»it application for ali waste units r .julat-nl
under State law. Oaaad on that lufo rotation, the :itat« should
,-roctsed to t-rocca« and issue a RCKA r^trait cove-ring ail HCRA-r.cru-
latcd units at tn« facility. Units containing taix«d wastes (or
auaroct-d oi containing Bi.z«d wastes) are currently not covered
und«r the authoric»d RCRA program in Coutn Carolina. ik?w*v«r,
..- tnt Ltate ragulat*s mixed waste* unUer ^tata lav, units
containing such wastes may also be addressed wituin the State
The State should obtain security clearances, where
necessary, anu use its Cull range of «m orcttstt»nt authorities
to gain access to the site and to require sampling and analysis
L>y the facility to determine whether units should bo regulated.
headquarters DOS has assured full cooperation in obtaining
security clearances i'or utat* personnel.
EPA can also use Its H&VA authorities to supplccent an auth-
orized State's authority over RCRA-rw^ulateU units. Under »3uU4(u).
«PA can jointly issue a permit with the State and lapose corrective
action requirueients OB hazardous «e,ste manaqeaent units and solid
waste nanagemcnt units (SWMU'a) at facilities that contain RCRA-
reculatsd units. Altnou%h miaed waste units are not KCRA -regulated
under luthorized State ACJtA programs, mixed waste will be cons icier eu-
ro co a "solid wast** for purj'osea of corrective action at solid
waste aanagement uoits*
Vhe federal definition of "solid waste* is to be used in
J^&craiainaj what units are ^WMU's, becaus* Stats definitions w«re
aot icrutialssd in evaluating applications for State authorization
(jxC'.-Kt as was necessary to assess the adequacy of the state's
universe of bacardous vasts).* Cccauso p.ixed waste is cons id or ad
a jo lie watrta under the federal RCftA pro^raa, uoits containing
;.-dx»d wastes are SWMU's and ars subject to corrective action if
t:.«>r^ is another uait requiring a RCRA permit at the facility.
* Vaer«»fori, in order to obtain authorization lor corrective
action, Ltatrs must obtain authorisation .or their definition
of solid waste, which may not exclude fixed waste.
-------
*s r.c'tac! earlier* A rivc»e Jt least
on* ncn-nixeJ, hazardous *^ste unit at a facility in order tor
l.r'A to -iut/jact wixe-1 w^st^ unit.« to crrr^ctive action r-*quir«»^ont5
,-av issue an order arvusr 3J003(h) re-~uiri"<7
iti-rinr;, ir.vest i^ation ot releases and corrective action, t»u't
or'Jer can arply to ^iK**'. xa«!te units only if there ia or? or
unit subject to interi^< ^t*tu» require««ents at the ^ite.
to S*;«»rifie ';t?estior«
In response to the thr«* Bullets and the three nimberen
:* un :>a^e 2 of your .^enorancium, we r>av« the Collowino
answers:
• If you suspect that Part tf's have not been «ubtnitted
for all nCXA units, LPA and/or the State should tace
inaeriiate enforcettont action, tou an4 the state should
determine who ahould appropriately take enforcement
action* If there are rained waste units in nuestion,
ZPA cannot enforce subnieaion of the Fart 3's in an
authorized State, while CPA cannot issue penalties to
anotner Federal agency/ the dispute resolution process
oescrined in the revised federal Facility Compliance
btrateay tnay be used.
• -J-view of the Part B submitted by SRP nay provide you
and/or the state with sufficient information to :«ake
such a determination. However* if it does not, then
CPA and/or the State should recuire SP*», through enforce
ment action, to e appropriate*
• As stated earlier, the booklets only provide a starting
point for negotiations. SPA HQ will not be reviewing
or approving the individual facility booklet*.
1. The nay 10 letter to COI did not delegate any authority.
Therof«r«, it need not be withdrawn.
2. Th« IdA definition of byproduct is th« only appropriate
and legally enforceable cofinition that can be used.
You should use that definition to aak« case-by-case
decision*, as described on page 2 of this memorandum.
3. There is no documentation availabU of the CPA review
of the SRP waste stream booklet.
-------
I note tftis surf icientiy clarifies your rocr«ss you and tf.e state of
couth Carolina are mafcinu in resolving these i.isues-«ith SPP.
cc: r» scarwroc-n, «ron IV
i^enion IV
Tony Baney, OV-*t»E
Pett?r 'Cuerrero, USW
Division Directors, Regions I-III, V-X (with incof*ino)
Branch Chiefs, Kegions I-III, V-X (with incoming)
bcc: Henry Elsen, Regional Counsel (613),
Region X (with incoming)
State Programs Branch
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f WASHINGTON. 0 C 20450
9432.1936(0
THE AOMINISTBATQP
Honorable Alan K. Simpson, Chairman
Subcommittee on Nuclear Regulation
United States Senate
Washington, D.C. 20510
Dear Senator Simpson:
In your letter of March 19, 1986, you posed a number of
questions pertaining to the Subcommittees' joint hearing on
March 25 on the regulation of mixed hazardous and radioactive
substances under the Resource Conservation and Recovery Act and
the Atomic Energy Act.
Our responses to these questions are enclosed. Please let
me know if we can provide further assistance on this issue.
Sincerely,
Lee M. Thomas
Enclosure
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ANSWERS TO QUESTIONS FOR THE ENVIRONMENTAL PROTECTION AGENCY
JOINT MIXED WASTE HEARING — MARCH 25, 1986
Question 1;
Please identify all waste streams that contain both hazardous
waste, as that term is defined in the Resource Conservation and
Recovery Act, and source, special nuclear, or byproduct material,
as those terms are defined in the Atomic Energy Act, mixed in-
separably in a sinole waste stream. Please include in your
analysis all such waste streams, including, but not limited to
mixed wastes currently defined by the NRC as low-level radioactive
waste. For each such waste stream, identify the source of genera-
tion, the process or activity that results in the generation of
such waste, the amount of waste generated on an annual basis, the
hazardous waste substance contained in such waste stream, whether
such hazardous substance is currently regulated or is subject to
regulation pursuant to RCRA, and all treatment, storage, manage-*
ment, or disposal options currently permitted, licensed, or
otherwise authorized by EPA or by the NRC (or an Agreement State)
for such waste.
Answer:
The information requested concerning NRC-regulated wastes is
contained in two NRC reports:
( 1) An Analysis of Low-Level Wastes: Review of Hazardous Waste
Regulations and Identification of Radioactive Mixed Wastes (NUREG/
CR-4406).This report describes the types and volumes of mixed
waste currently being generated and disposed of by commercial NRC-
licensed facilities. Analyses of waste streams were not conducted
for this survey/ however, and respondents to NRC's survey account
for only 29 percent of the total low-level radioactive waste (LLRW)
disposed of in 1984. The survey focused on three broad categories
that may be radioactive mixed wastes: waste containing organic
liquids called liquid scintillation wastes (2.3% of LLRW), wastes
containing lead shielding or lead containers (.1% of LLRW), and
wastes containing chromium (.7% of LLRW).
(2) flihaqement of Radioactive Mixed Wastes in Commercial Low-
level wastes (NUREG/CR-4450).This is a draft report which is
subject to revision.
DOE also has conducted mixed waste stream studies. Reports
from these studies are now in draft form. The drafts are being
revised and the revisions have not yet been provided to EPA. The
drafts identify numerous DOE mixed wastes. The majority contain
contaminated solvents or used oil. DOE generates roughly
12 million tons per year of mixed waste.
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Question _'
In December of 1985, tne NRC published a report entitled
"An Analysis of Low-Level Wastes: Review of Hazardous Waste
Regulations and Identification of Radioactive Mixed Wastes"
'(NL'REG/CR-4406) . Is this report/ in your judgment, a comprene-.s :ve
summary of all low-level radioactive mixed wastes that are
currently of regulatory concern to the EPA from the standpoint of
EPA's regulatory responsibilities under RCRA? Is this report a '
complete and accurate depiction of the volumes and types of sucr.
waste, as well as the sources of generation?
Answer:
EPA believes that the NRC report is generally accurate in
describing low-level radioactive mixed waste chat is regulated by
NRC. However, EPA personnel did not perform an on-site evaluation
of the wastes. In addition, the report is not complete in that
the survey accounts for only 29 percent of such NRC-regulated
facilities. Furthermore, the report does not address low-level
radioactive mixed waste that is generated and managed by DOE.
Question 3;
with respect to the hazardous substances contained in the
•nixed waste streams identified in response to question 1, has EPA
oromulgated all of the regulations necessary to implement RCRA
(including the 1984 amendments to RCRA)? Specifically, has EPA
established all regulations necessary for: (i) any interested
party to file an application with EPA for a permit to construct
and operate a facility to dispose of such mixed wastes; and (ii)
EPA to evaluate and approve such an application? If not, what
additional regulations will be necessary, what issues will those
regulations address, and when will those regulations be in place?
In tne absence of such regulations are there any existing facilities
in which EPA permits such mixed wastes to be disposed of? If so,
where? What ^t«ps, if any, would these facilities be required to
ta
-------
Question 4;
Are there any other statutes, aside from RCRA and the Atomic
Energy Act/ that apply to the disposal of low-level radioactive
nixed wastes? If so/ please summarize tne requirements of tnose
statutes. Has EPA promulgated all necessary regulations to
implement the requirements of these statutes with respect to the
disposal of low-level radioactive mixed wastes?
Answer;
The Comprehensive Environmental Response, Compensation/ and
Liability Act {CERCLA) and the Clean Air Act (CAA) both apply to
tne disposal of low-level radioactive waste. Hazardous and
radioactive releases from a low-level radioactive disposal site
would be subject to CERCLA. Low-level radioactive waste sites
are subject to the CAA relative to radiation releases to the air.
Question 5:
With respect to the source/ special nuclear/ or byproduct
material contained in the low-level radioactive mixed waste
streams identified in response to question 1, does EPA impose
any regulatory requirements to protect the public health and
safety and the environment from the hazards posed by such
materials? If so/ please describe those requirements.
Answer:
Through EPA's Office of Radiation Programs, and pursuant to
the AEA, regulations are being developed that would establish the
minimum health standards relative to radiation release from low-
level waste disposal facilities. In addition/ EPA has already
issued such rules (40 CFR 191) pertaining to high-level waste
disposal. These standards include limits on releases over 10/000
years/ exposure to individuals, contamination of ground water,
and assurance requirements of a qualitative nature.
Question 6;
With r««p«ct to th« hazardous substances contained in the
low-level radioactive mixed waste streams identified in response
to question I, do th« regulatory requirements currently imposed
by the NRC_U.e., 10 CFR-Part 61). provide a level of protection
that is adequate to protect human health and the environment,
as required under RCRA/ if those wastes are disposed of in a
low-level radioactive waste disposal facility licensed pursuant
to Part 61?
Answer:
This question cannot b« answered fully at this tim«, since
there has never been a comprehensive analysis of the two regulatior
-------
co determine equivalent protection. On the surface, however, it
appears that -NRC's rules may not provide eauivalent protection
since they do not require protective measures similar to RCRA
standards; e.g., liner and leachate collection systems tnat were
mandated by Congress in the 1984 RCRA Amendments.
Question ":
Aside from disposal in a licensed low-level radioactive
waste disposal facility, what other options are available for the
treatment or management of low-level radioactive mixed wastes? '
Can any or all of these wastes be effectively incinerated? If so,
wnich ones? Are there facilities available that provide such a
service? If so, where? Can any or all of these wastes be decon-
taminated, eitner through chemical, mechanical, or other processes?
If so, wnich ones? Are there facilities available that provide
such a service? If so, where? Aside from these options, are
there other alternative management or treatment options now
available, or likely to be available in the future, that would
eliminate or minimize the need to dispose of low-level radioactive
mixed wastes in a licensed low-level radioactive waste disposal
facility? Can low-level radioactive mixed wastes be treated or
manaqed so that disposal in a licensed low-level radioactive
waste disposal facility is not necessary?
Answer;
Some constituents in low-level wastes can be effectively
incinerated. These include such wastes as solvents, paper, wood,
clothing, and plastics. If a mixed waste is involved, however,
the incinerator would need both a RCRA permit and an AEA license.
Currently, DOE has a facility in New Mexico for incinerating PCB
mixed waste. This is primarily a research unit located at Los
Alamos. Quadrex PHS, Inc., in Gainesville, Florida, handles
liquid scintillation vials.
Decontamination can also be a method for managing low-level
wastes. The facilities engaged in these activities are primarily
recyclers of slightly contaminated materials (heavily contaminated
materials are avoided). Those wastes most likely to be a candidate
for decontamination are reusable materials—e.g., tools, machinery,
equipment, *nd protective clothing. EPA is not aware of any
commercial_facilitie» that decontaminate mixed waste itself.
The NRC study identified in question 1, Management of Radio-
active Mixed Waste in Commercial Low-level Wastes, addresses
management options for eliminating mixed waste streams from
commercial low-level waste.. In summary, the NRC report describes
methods that can be implemented today for reducing or eliminating
mixed waste from commercial low-level waste.
-------
Question 8:
Please summarize all procedural and substantive problems
identified by EPA with respect ^o tne regulation of low-level
radioactive mixed waste, if such waste is required or allowed
to be disposed of in licensed low-level radioactive waste
disposal facilities?
s
Answer:
The major procedural problem associated with the disposal
of mixed waste at an NRC-licensed facility is dual permitting .
to comoly with the requirements under both RCRA and AEA. (Dual
oermitting is not a concern at DOE facilities because DOE does
not issue permits under the AEA.) These requirements sometimes
are in conflict. For example, RCRA Section 264.13(a)(4) requiring
inspection or analysis of waste is an issue since it miqht expose
worKers to radiation.
The major substantive problems identified appear to be RCRA
requirements for liners and leachate collection, corrective
action, and bannina the land disposal of specific waste (all
required by the 1984 RCRA amendments).
Question 9:
What recommendations, if any, does EPA have for resolving
these procedural and substantive problems in the frameworK of the
existing law? Can any of these problems be resolved in the
frameworK of the existing law?
Answer;
As mentioned earlier* EPA is planning to propose amendments
to its RCRA rules addressing radiation hazard aspects of mixed
waste this summer. We believe these amendments will allow
resolution of some of the substantive problems in the frameworK
of the existing law,
Question 10:
What recommendations, if any, doe* EPA have for new
legislative authority eo address these procedural and substantive
problems? Please explain in detail the need and justification
for any legislative modifications recommended by EPA.
Answer:
As for the major procedural problem (dual AEA/RCRA permits),
EPA recommends legislative amendment to RCRA. As currently
written, RCRA does not allow EPA to delegate authority to another
Federal agency, such as NRC, to issue RCRA permits. The States,
in turn, can be delegated authority to regulate mixed waste as
-------
part of rne R.CRA program. This, is a viable solution to dual oer-
mitting for NRC Agreement States where NRC-licensed facilities a-e
located. It does not resolve potential substantive differences,"
howe ve r.
For DOE facilities, dual permitting is not a .concern under
either Federal or State rules. In the event of disputes (e.g.,"
whether certain RCRA rules should be waived because tney would
increase tne radiation hazard) between a State and DOE, tne «tate
could consult EPA or, if it disagrees with attempts to reconcile
differences, institute court action to resolve tne issue.
Question 11;
Does EPA support the procedural approach established in
Section 11 of S.1578, as passed by the Senate, for resolving any
conflicts between EPA and NRC in the regulation of low-level
ra'dioactive mixed wastes? Specifically, does EPA support the
delegation of EPA«s RCRA permitting authority, in the manner
described in section ll(c)(2)?
Answer;
«
EPA has two concerns with S. 1578, Section 11. These concerns
are: -
(1) The Bill as now written would create an "orphan" waste.
The orphan waste would be that which NRC banned under Section
ll(c)(3), and which RCRA sites would not want to take because of
concerns over the radioactive aspect of the waste.
(2) The Bill does not address Naturally Occurring and Accelerator
Produced Radioactive Materials (NARM). NARM wastes that are low leve^
could, of course, be handled at low-level radioactive waste sites.
The AEA does not provide authority to regulate NARM wastes. RCRA
does provide EPA with such authority, but we do not currently
regulate NARM wastes. Most States, however, do have controls for
such wastes.
Question 12;
Please comment on the Department of Energy's proposed
ruling on the definition of byproduct material. Will this rulemaKing
affect EPA's regulation of hazardous substances and mixed wastes?
Answer: "^~
In December 1985, DOE formally proposed a definition of
byproduct material. EPA commented on the proposal in February
1986, stating that a rule-defining "byproduct material" was not
necessary, and that the facility waste stream studies should be
the basis for a RCRA/DOE .mixed waste program. In effect, we
believe that the two agencies (DOE/EPA) can resolve the issues by
getting together and determining what is covered by RCRA and what
is not.
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Mixed waste will continue to be regulated under RCHA, recard-
less of whether or not the byproduct rule is promulgated. The
proposed definition could, however, affect what is considered to oe
"mixed waste."
Question 13;
What impact, if any, will EPA's currently ongoing revision
of its RCRA regulations, including those revisions necessary to
conform to the 1984 Amendments to RCRA, have on the ability of
tne States to meet their obligations pursuant to Public Law 99-
240? Will these revisions have any impact on the ability of tne
States to meet the milestones, or any other requirements, in
Public Law 99-240? Will the regulations, currently under
development by EPA to implement the 1984 RCRA Amendments apply to
a low-level radioactive waste facility that accepts low-level
radioactive mixed waste for disposal? If so, what impact will this
have on the selection, licensing, construction, and operation of
sites in accordance with the framework established in Public Law
99-240?
• «.
Answer:
EPA's response to the 1984 Hazardous and Solid Waste Amendments
will require a number of major modifications (e.g., location
standards, air standards, and new waste listings and characteristic
to the RCRA standards over the next few years. These new rules
could have an impact on the State programs under RCRA and the AEA.
They could have have an impact on the siting and permitting/licensinc
of new low-level radioactive waste facilities by 1993, as required
by the Low-Level Radioactive Policy Act Amendments of 1986, if
these facilities also handle hazardous or mixed waste. Since RCRA
standards apply to mixed waste* it would be necessary for States to
comply with both RCRA and NRC requirements. There are differences
between these regulatory requirements—such as RCRA requirements to -
analyze waste and to collect and remove leachate at disposal sites—
that would have to be reconciled with NRC requirements. In addition,
State RCRA programs will be under continuous revision in order to
maintain the statutorily mandated equivalence to the Federal RCRA
program as new rules are promulgated. The uncertainty of RCRA
requirements might affect States abilities to site LLW facilities,
if these facilities were also intended to handle mixed waste, we
would note, however, that any regulatory program is subject to
review and-*+vision at any time. This situation is not unique to
RCRA.
Question 14:
What steps, if any, have EPA and NRC taken, to ensure that
the regulatory requirements of RCRA and the Atomic Energy Act are
applied, with respect to low-level radioactive mixed wastes, in
accordance with the reguirements of section 1006U) of RCRA?
("Nothing in this Act shall be construed to apply to (or to
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authorize Any State, interstate, or local authority to regulate
any activity or substance wnicn is subject to....tne Atomic Energy
Act of 1954...except to the extent that such application (or
generation) is not inconsistent with tne requirements of such Act."'
Answer:
:
EPA and SRC are wording together to coordinate their regulatory
responsibilities for mixed waste. The preparation of the two
NRC reports cited in the answer to question 1, which identify the
universe of mixed waste, was an essential first step.
In addition, EPA, NRC, and DOE are examining two options to
ensure consistency between RCRA and the AEA: separate jurisdiction
based on primary concern and delegation of authority. Under the
first option, Congress could divide the mixed waste universe into
pieces, with each piece regulated by a single authority (NRC or
EPA) under only one statute. The waste would then be exempt from
regulation by the other statute. One way to do this would be to
examine each waste stream and assign jurisdiction based on primary
concern about the waste stream (i.e., radioactivity or other
hazards). One problem with this option would be deciding which
criteria to use to determine the primary concern and/or to-assig_n
jurisdiction. In addition, since RCRA is a dynamic program,
this approach likely would require a waste stream evaluation each
time there is a new RCRA hazardous waste characteristic or waste
listing. This requirement for continuous reevaluation could be
modified, however. For example, we could create a mechanism that
would cluster amendments to the RCRA rules and only periodically
mandate that DOE and NRC pic* up these changes. This option
would require a statutory change to exempt certain mixed waste
from the AEA or RCRA.
The second option for issues relatinq to NRC would be to
continue co have multiple jurisdiction, but co enable delegation
of permitting and enforcement authority to one agency and provide
for that agency, in turn, co delegate to its implementing States.
This approach could woric in on* of two ways: (1) delegate RCRA
permitting and enforcement co NRC (i.e., NRC would issue the RCRA
permit at AEA/NRC sices) or (2) delegate AEA licensing and
enforcement authority to EPA (i.e.* EPA would issue and enforce
the AEA/EPA license at RCRA sites). Once again, tne agency with
jurisdiction could be determined based on the primary concern
with the wrote stream. Either delegation would require a
legislative' amendment to the statute whose authority is delegated.
This approach still would require EPA and NRC to resolve
regulatory conflicts or differences, but it would avoid the
problems and costs of dual" permitting and enforcement.
Question 15;
Please describe the applicability of RCRA to Department of
Energy facilities.
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Answer?
RCRA applies to all DOE facilities that generate, store,
treat/ or dispose of hazardous waste.
Question 16;
Please describe how mixed wastes at Department of Energy
facilities are regulated under RCRA.
Answer:
DOE facilities are currently subject to RCRA if they generate,
store* treat, or dispose of hazardous waste. The majority of
States are authorized to operate hazardous waste control programs
in lieu of the Federal EPA program. Mixed waste, however, is
currently beyond the scope of authorized State programs. Therefore,
in these States, mixed waste can be regulated only under State
law. In unauthorized States, however, EPA has authority to
regulate mixed waste.
*
Question 17;
Please comment on S. 892. Do you support this bill? Please
explain.
Answer:
This bill would amend the RCRA definition of "solid waste-
to include source, special nuclear or byproduct materials when
those materials are mixed with solid waste, and (1) when those
materials are in the generation, transportation, storage, or
treatment stage, or (2) when those materials are disposed of at
an AEA facility or~~DOE or other unlicensed locations. Section 5
provides that these amendments shall not be construed as altering
the intent of Congress as to whether RCRA applies to mixed waste
disposed of at NRC-licensed facilities. Despite this disclaimer,
the bill does raise questions as to EPA's authority over mixed
waste at NRC-licensed facilities because it is not mentioned
explicitly in Section 4 with DOC wastes. Waste disposed of at a
"repository* (under the Nuclear Haste Policy Act of 1982) would
also not be included as solid waste under RCRA control. For
these reasons, EPA would suggest a modification in language to
clarify th^se points.
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9441.1936(17)
RCRA/SUPERFUND HOTLINE MONTHLY SUMMARY
FEBRUARY 86
5.. Definition of Solid and Hazardous Waste
Section 261.2(e)(l)(i) was promulgated on January 4, 1985, (50 FH 664) as
part of the ncv definition of solid waste. It states tr.au rr^aterials are net
solid wastes when they can be shown to be recycled by being used or reused
as ingredients in an industrial process to make a product, provided tne
materials are not being reclaimed. This is significant because materials
that are not solid wastes per §261.2(e) (1)( i) are not hazardous wastes, and
therefore, are not subject to RCRA regulations.
A chesr.ical manufacturing plant generates spent sulfuric acid. The spent acid
is reintroduced into the production process, wnere it is decomposed into its
constituents (e.g., 502). These constituents can then be used to produce
mere sulfuric acid, fcouid. tne process of reintroduction and decomposition
constitute reclamation, thus precluding the plant from the exemption?
Spent sulfuric acid is frequently used as a feedstock in the production
of virgin sulfuric acid. Accordingly, EPA has promulgated a specific
exclusion stating that spent sulfuric acid recycled in this way is not
a solid waste (S261.4(a)(7)). The recycling process more closely resembles
a manufacturing operation tnan a reclamation process. Nate that: (1)
sper.t sulfuric acid is subject to the speculative accumulation provisions,
as defined in §261.1 (c); and (2) the spent acid *ould be a hazardous
waste if disposed (assuming it is corrosive or exhibits another hazardous
waste characteristic) and could be a hazardous waste if recycled in
sane other manner (see the January 4, 1985 Federal Register (50 FR 642)).
Source: Matt Straus (202) 475-855:
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Hazardous Waste
Exclusions
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Exhibit III
Hazardous Waste Exclusions
(Most don't apply to hospitals. General Reference.)
Overheads from Presentations
Relevant Federal Regulatory Citations
RCRA Policy Excerpts
EPA Region 2 51
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Exhibit III-1
A Solid Waste May Be Excluded As A Hazardous Waste
261.4(b)
•The regulations also specifically exclude certain solid wastes from being considered a hazardous waste.
•Some of these exclusions are specified in the RCRA statute; others are the result of effective lobbying efforts and participation in the regulatory
development process.
EPA Region 2 52
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Exhibit III-2
Hazardous Waste Exclusions
• Household Waste
- A resource recovery facility managing municipal solid waste is not
managing hazardous waste as long as:
I The facility receives and burns only household waste or solid
waste from commercial or industrial sources that does not
contain hazardous waste
I The facility does not accept hazardous wastes
• Waste from university dormitories and military bases also fall under the
exclusion, but not nursing homes (which are considered healthcare
facilities)
Note: Healthcare, dental, and laboratory facilities on
bases and in dormitories are not excluded
261.4(b)(l)
•Household waste includes garbage, trash, and sanitary wastes in septic tanks from single-family houses, apartment buildings and hotels, ranger stations.
crew quarters, campgrounds, picnic grounds, and day-use recreation areas.
•Clarification of the household waste exclusion was provided by Congress in HSWA.
EPA Region 2 53
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Exhibit III-3
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Solid waste generated by any of the following and which are
returned to soils as fertilizers
- Growing and harvesting of agricultural crops
- Raising of animals, including animal manures
• Mining overburden returned to the mine site
261.4(b)(2)and(3)
All of these exclusions have historic reasons.
•In 1976, when RCRA was enacted, the US was faced with problems in the agricultural area and did not want to place additional burdens on farmers.
•Mining overburden exemption is similar to the solid waste exclusion; the solid waste exclusion if the overburden never "sees the light of day," the
hazardous waste exclusion is provided if the wastes are created above-ground, but returned to the place in which it was mined.
EPA Region 2 54
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Exhibit III-4
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Fly ash waste, bottom ash waste, slag waste, flue gas
emission control waste generated primarily from
combustion of gas or other fossil fuel except as provided by
266.112 for facilities that burn or process hazardous wastes
• Drilling fluids, produced waters, and other wastes
associated with the exploration development, or production
of crude oil, natural gas, or geothermal energy
261.4(b)(4)and(5)
•In 1976, when RCRA was enacted, the US also faced problems in the energy area.
•Therefore many wastes generated by these industries obtained exemptions.
•These wastes must still be managed as solid waste in accordance with Subtitle D requirements.
EPA Region 2
55
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Exhibit III-5
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Wastes which fail the test for the toxicity characteristic because
chromium is present, or are listed due to the presence of chromium, as
long as no other constituent is present
• Specific wastes generated from the leather trimming and finishing
industries which meet the chromium exclusion
261.4(b)(6)
•These exclusions resulted from additional information received by EPA after the original promulgation of the regulations in 1980.
•These exclusions apply mostly to the leather tanning industry.
•EPA is re-examining these exclusions to determine if they should remain. The reason is that the new toxicity characteristic uses total chromium - not just
trivalent chromium. The Agency has obtained new data showing that, under certain circumstances, trivalent chromium converts to hexavalent chromium.
•For the first exclusion [261.4(b)(6)(i)] the following additional criteria must be met:
- Chromium is exclusively trivalent chromium.
- Waste is generated from an industrial process which uses trivalent chromium.
- Process does not generate hexavalent chromium.
- Waste is typically and frequently managed in non-oxidizing environments.
•For the second exclusion [261.4(b)(6)(ii)], the specific excluded wastes are:
- Chrome trimmings.
- Chrome shavings.
- Buffing dust.
- Sewer screenings and wastewater treatment sludges.
- Waste scrap leather.
- Wastewater treatment sludges from the production of TiO2 pigment.
EPA Region 2 56
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Exhibit III-6
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Certain solid waste from the extraction, beneficiation, and
processing of ores and minerals (including coal), including
phosphate rock and overburden from the mining of uranium ore,
except as provided by 266.1 12 for facilities that burn or process
hazardous wastes
• Cement kiln dust, except as provided by 266.1 12 for facilities that
burn or process hazardous wastes
• Discarded wood treated with arsenic, or wood products which fail
the test for toxicity
_ 3), (9) and (10)
•The first exemption is the Bevill Amendment. EPA has amended this exemption which we will discuss in a moment.
•Cement kiln dust exclusion continues to be of concern, mainly because of the ability of cement kilns to properly manage hazardous wastes by burning for
energy recovery. Wastes from other thermal treatment activities are not provided the same automatic exclusion.
•The wood treatment exclusion also includes the condition that the wood waste is not hazardous waste for any other reason and the waste is generated by
persons who utilize the arsenic -treated wood for the intended end use. This exclusion was an attempt to remove from regulation materials and
management practices (that are basically the same as using the materials) which do not pose extreme hazards to human health or the environment.
EPA Region 2 57
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Exhibit III-7
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Petroleum-contaminated media and debris that fail the toxicity
characteristic and are subject to UST Corrective Action regulations
• Injected groundwater that is hazardous only because it exhibits the
Toxicity Characteristic, (Waste Codes DO 18 through D043 only) that is
reinjected through an underground injection well pursuant to the phase
hydrocarbon recovery undertaken at certain petroleum facilities until
January 25, 1993
• Used chlorofluorocarbon refrigerants from totally enclosed heat transfer
equipment, provided the refrigerant is reclaimed for further use
•The petroleum-contaminated media exclusion is intended to avoid duplication of regulation, since the waste is covered under the UST regulations.
•Injected groundwater added October 5, 1990 and revised April 2, 1991.
•Chlorofluorocarbons added February 13, 1991.
EPA Region 2 58
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Exhibit III-8
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Bevill Amendment
- Solid waste from the extraction, beneficiation, and
processing of ores and minerals (including coal),
including phosphate rock and overburden from the
mining of uranium ore, except as provided by 266.112
for facilities that burn or process hazardous wastes
261.4(b)(7)
•This was the original statutory language.
•EPA originally interpreted the exclusion very broadly.
•EDF sued EPA to force them to clarify and limit the exclusion; the American Mining Congress countersued.
•Results - EPA amended regulatory language to: (a) set criteria for wastes to qualify for the exclusion and (b) clarify which wastes were excluded from the
exclusion (i.e., included in the Subtitle C program).
EPA Region 2 59
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Exhibit III-9
Hazardous Waste Exclusions (Cont'd) -
Not Hospital Related
• Bevill Amendment Criteria for Exclusion
- Must be a mineral processing waste
- Must be generated in high volume
- Must be of low hazard
261.4(b)(7)
•Mineral Processing wastes are defined as materials which:
- Are solid waste as defined by EPA.
- Are uniquely associated with mineral industry operations.
- Originate from mineral processing and possess certain attributes.
•High volume are mineral processing wastes which:
- For non-liquids, are generated at an annual rate of > 45,000 metric tons/year/facility.
- For liquids, are generated at an annual rate of > 1 million metric tons/year/facility between 1983 and 1988.
•Low hazard, high volume mineral processing wastes are excluded if:
- Waste extracts (using SW-846, method 1312) contain concentrations of certain inorganics < 100 times MCL at 2 or more facilities - with certain
additional caveats.
- Constituent concentrations are used to determine facility-level values using certain criteria.
EPA Region 2 60
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Exhibit III-10
Other Hazardous Waste Excluded from
Regulation - Not Hospital Related
• Samples of solid waste or samples of water, soil, or air collected for the
sole purpose of testing to determine their characteristics or composition,
during storage or transportation
• Samples collected for the purpose of treatability studies during storage
or transportation
• Samples undergoing treatability studies at laboratories and testing
facilities. Note: After analysis is complete, samples are regulated if
listed or characteristic.
To qualify for these exemptions, a shipper must comply with the proper
shipping requirements (DOT, USPS, and any other requirements)
\
261.4(d),(e),(f)
•These three exclusions are intended to facilitate analysis necessary to determine the regulatory status of a waste or the ability of a process to treat a waste.
•These exclusions apply only in limited situations.
EPA Region 2 61
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Exhibit III-11
Relevant Federal Regulations
40 CFR Part 261
261.4 (b)
EPA Region 2 62
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