United States
Environmental Protection
Agency
Office of
Enforcement (EW-342)
Washington, DC 20460
September 1980
OPA 1/1
Toxic Substances.
Enforcing the law
-------
Citizens concerned about toxic substances are joining
together in communities all across the country in efforts to
identify specific local problems that may be threatening
their health and the environment. Identifying a specific
problem is only the first step, however, and citizens
discover that finding the best way to resolve it is a difficult
and complex task.
There is a large body of local, state, and federal law
governing toxic substances, but too often these laws do
not seem to address the specific situation that has been
identified. Determining the most fruitful course of action
involves thoughtful and creative consideration of
alternative remedies such as seeking an enforcement
action under one or more of the existing statutes or
applying public pressure in an attempt to get the problem
resolved voluntarily. The most important consideration for
citizens interested in an individual problem is to ensure
that their energies are channeled in a direction that has
the greatest possibility for results.
Although a remedy through enforcement action is
often seen as the quickest and most obvious alternative
solution to a toxics problem, concerned citizens are often
frustrated when they meet what is apparent inaction on
the part of government officials asked to respond to their
problem. This brochure has been designed to help citizens
understand the enforcement process, the constraints on
this process, the opportunities for action enforcement may
provide, and the ways in which citizens can participate in
enforcement programs.
The focus of this brochure will be on enforcement of the
federal Toxic Substances Control Act (TSCA), since TSCA
clearly states the intent to prevent unreasonable risk of
injury to health or the environment presented by exposure
to toxic chemicals. Each environmental statute, however,
presents comparable limitations and opportunities to
consider when exploring the possibility of resolving a
problem through enforcement action.
-------
Overview of the
Toxic
Substances
Control Act
The Toxic Substances Control Act (TSCA), Public Law 94-
469, was enacted in 1976 to "regulate commerce and pro-
'tect human health andthe environment by requiringtesting
and necessary use restrictions on certain chemical
substances." TSCA was designed to correct the current
lack of health and safety information about chemical
substances and to prevent unreasonable risk of injury to
health or the environment presented by exposure to toxic
substances.
To carry out the mandate of TSCA, the U.S. Environ-
mental Protection Agency (EPA) is authorized to obtain
from industry data on the production, use, and health and
environmental effects of chemical substances. If this
information shows that controls are warranted, EPA may
regulate the manufacture, processing, distribution in
commerce, use, and disposal of a chemical substance.
TSCA is an extremely complex law. To help understand
how TSCA works, it is useful to think of it in two phases. In
the first phase, health and safety data is gathered and
analyzed to determine the risks posed by a chemical. In
the second phase, various controls can be placed on the
manufacture, use, or distribution and sale of chemicals
that have been found to pose a risk to health or the
environment. These controls are based on the information
gathered in the first phase.
There are several stages of information gathering
during the first phase, and each chemical will be at a stage
of investigation consistent with the current state of
knowledge about its toxic effects. Agency experts expect
to find that of the approximately 70,000 chemicals
known to exist, roughly 1,000 are seriously toxic. EPA has
classified many of these existing chemicals based on the
amount of scientific data currently available. For some,
the Agency will adopt test rules requiring industry to
perform specific tests to determine health and safety risks
because an inadequate amount of data currently exists.
Such tests may take several years to perform. For other
chemicals, the Agency has a significant amount of
information regarding toxic effects but lacks sufficient
data regarding the nature and extent to which people or
the environment will be exposed to the chemical during
its manufacture or use. EPA must obtain such exposure
information before it can make a decision regarding
appropriate controls. In other cases, much is known about
risks and exposure, but an extensive analysis is needed to
determine the best way to control the chemical without
causing undue loss of jobs, shortage of consumer
products, or other unwanted effects.
-------
The end result of this process is the development of a
control regulation specifically designed for the individual
chemical. Chemical control regulations can ban or restrict
rrianufacture, impose qualrty control procedures for
production, prohibit or restrict distribution in commerce,
prohibit or restrict uses, and establish procedures for
disposal of the chemical.
This two-phased approach applies to existing
chemicals. However, if a company wants to begin
manufacturing a new chemical or use an existing
chemical in a significantly new way, the company must
notify EPA in advance. The notice must include
information about exposure and toxicity. The Agency
reviews the information and decides whether the
production or new use can be allowed, and if allowed,
under what restrictions. This process helps ensure that
new chemicals or uses will not be introduced unless their
safety has been demonstrated and that any needed
controls will be in place prior to production.
Each time the Agency proposes a rule to require the
reporting of information or testing of a chemical, it must
justify why the information is needed, including an
analysis of the cost of obtaining it. Since chemical control
regulations may result in significant changes in the
industries which manufacture or use the chemical, the
need for the regulations must be supported by extensive
scientific, technical, and economic analyses.
The process of gathering data about a chemical,
evaluating the risks, and designing a control regulation
can take many years. The large number of chemicals that
are potential candidates for control regulation has
required the Agency to set priorities based on known or
suspected degrees of risk as well as on the level of
information that is currently available. Because of
resource limitations, the Agency simply cannot work on all;
chemicals with the same degree of intensity at the same
time.
Citizens hoping to useTSCAas a means for resolving an
immediate local problem must first determine at what
stage of this lengthy process the chemical in question Hes.
If they find that the chemical is under consideratiorvfor a
testing rule or that the Agency has already asked industry:
clear indication that a control regulation is a long way off
and that some other statute may provide more immediate
relief. By contrast, if a chemical control regulation is in
place or under intensive development, TSCA may provide
the strongest or most explicit remedy.
This is not to imply that there is no role for citizens
under TSCA. There are a number of ways in which citizens
can influence what happens: they can participate at all
stages of the various rulemaking activities, petition for
Agency action on a particular chemical, and assist in the
enforcement of regulations that are in place. The
possibilities for citizens participation in enforcement will
be discussed in the remainder of this brochure.
-------
Enforcement
Provisions
ofTSCA
It is unlawful to fail or refuse to comply with rules, orders,
and/or requirements of testing, premanufacture notifica-
tion, or chemical control rules; to use for commercial
purposes substances manufactured in violation of
premanufacture notification, chemical control, or
imminent hazard rules; or to fail or refuse to establish or
maintain records or submit reports required by any rule
under the Act.
Any person who violates TSCA is subject to a civil
penalty of up to $25,000 per day per violation. In
determining the specific civil penalty to be applied against
a violator, EPA must consider the nature, circumstances,
and gravity of harm of the violation as well as factors
concerning the financial and compliance status of the
violator.
The statute also allows for civil court actions to provide
for immediate injunctive relief to correct serious
problems.
If a person knowingly or willfully violates the Act, he
may receive a criminal fine of up to $25,000 per day per I
violation and/or be imprisoned for up to one year.
-------
The Enforcement
Program
Rulemaking Stage
Enforcement
Strategies
An important consideration in the drafting of a rule is
ensuring that it is enforceable. EPA enforcement officials
assist in drafting regulations to make sure that the
requirements are sufficiently specific to tell the regulated
community what is and is not lawful conduct under the
regulation. During the drafting period, enforcement
personnel begin outlining strategies for enforcing
provisions of the draft rule. Various alternative means of
detecting possible violations are explored, including how
inspections could be used to monitor compliance. This
exercise helps pinpoint possible deficiencies in the rule
and is the first step in preparing for an enforcement
program once the rule is adopted.
As the rule passes from the draft to the proposed and then
final regulation stages, the enforcement staff continues
refining the enforcement strategy. Each enforcement
strategy identifies the industry groups that will be affected
by the rule, defines the ways in which the rule can
potentially be violated, and the ways violations might be
detected.
Since enforcement resources are limited, it would be
impossible to inspect every facility subject to the rule. So
that resources can be used most effectively, the strategy
also attempts to direct compliance monitoring activities to
segments of the regulated community which can be
expected to have the strongest incentive to violate and/or
whose violations will have the greatest effect on health or
the environment. The result is a neutral administrative
inspection scheme which provides for inspections of a
pre-selected sampling from target groups. A portion of the
inspection resources are reserved for response to
complaints an'd emergency situations.
In addition, the strategy identifies ways to foster
voluntary compliance with the requirements. Central to
this part of the strategy is the design of a program to
inform members of each affected industry of the
requirements.
These strategies are developed for each rule proposed
under TSCA. While rulemaking and strategy development
are in progress, enforcement personnel review comments
received from industry and the public, and attempt to
address those which have an implication for enforcement.
Interested individuals whp review proposed rules
should analyze the potential'for enforcement of the rule's
prpvisions and include their concerns about enforcement
in their comments. Such comments can be incorporated in
the rule itself and the strategy for its enforcement.
Enforcement strategies become public documents, and
comments and suggestions from interested groups will be
considered as the strategy is actually implemented.
-------
Enforcement Priority
Setting
Compliance
Monitoring
Inspection Scheduling
The level of overall TSCA enforcement activity is based on
the resources available, determined through the budget
process. The national budget ultimately reflects the
relative priority of each environmental program the
Agency administers, and then the relative priority of the
Agency's entire program to other national programs such
as defense, health and welfare, and education.
To arrive at priorities for enforcement of TSCA
regulations, enforcement staff analyze the seriousness of
the potential harm to human health or the environment if
violations of a regulation should occuj: Projections are
made of the number of inspections that would be needed
to provide minimum and maximum enforcement of each
regulation in the budget year. The overall TSCA enforce-
ment budget based on these projections competes with
budgets from other Agency programs, including the
budget from the Office of Toxic Substances which has
primary responsibility for developing TSCA rules.
The proposed overall Agency budget is approved by the
Office of Management and Budget and presented to
Congress. The final national budget establishes relative
priorities for meeting the country's many pressing
problems.
Compliance monitoring activities begin once a regulation
takes effect. Inspections are scheduled on the basis of the
strategy and neutral administrative inspection scheme
described earlier, or in response to a complaint or
emergency situation.
It is important to remember the two phases of TSCA,
because inspection activity related to the daia gathering
phase is different from that which takes place after a
chemical control regulation has been adopted. The
potential role for private citizens is different for each.
For the various data gathering rules, EPA is mostly
concerned that complete, accurate data is being reported
Inspections to discover a failure to report or reporting of
false or inaccurate data necessarily involve thorough
review of company files and records. Such documents
would not be available to people outside the firm itself,
and there would even be limited access by the firm's own
'employees. EPA does encourage citizens who have reason
to suspect reporting violations to inform the Agency, since
'tips are one good way for the Agency to learn about
possible violations. However, it is recognized that only a
limited number of individuals would be in a position to
observe this kind of violation.
-------
TSCA Inspections
The potential for citizen or worker complaints is much
greater for violations of chemical control rules,
particularly those which involve the physical handling of
the chemical (such as marking, storage, transportation, or
disposal of the chemical). If a suspected violation is
observed, the citizen should contact the appropriate EPA
Regional office. It is important to provide as much
information about the situation as possible so that EPA
will be able to determine the appropriate response. (See
sections below for suggestions on how to make a good
complaint and for a list of EPA Regional offices.)
TSCA authorizes inspection of any facility where chemical
substances or mixtures are manufactured, processed,
stored, or held before or after distribution in commerce to
ensure compliance with the Act and any rules or orders
issued under the Act.
There are a number of procedural requirements that
must be followed to ensure that the inspection has been
conducted under proper authority and jurisdiction. If they
are not carefully followed, it is possible that information
collected during the inspection will be inadmissable in an
administrative or civil court proceeding.
-------
Enforcement
Actions
Routine Cases
To determine whether the company is complying with a
TSCA rule or order, the inspector may review company
records, perform a physical inspection of facility
operations, and/or collect samples. If the inspector
encounters a suspected violation, he or she must fully
document the circumstances. This may involve such
activities as photocopying relevant records, photographing
the area, and taking samples of the chemical substance.
Samples are sealed and sent to a laboratory, accompanied
by a form which is signed by each person who handles the
sample. This "chain of custody" procedure ensures that
the sample has been under control at all times and that no
one has tampered with it.
America's system of justice rests on the principle of due
process, and this principle applies to enforcement of
environmental laws just as it does to any other law. The
findings on an inspection may result in economic (civil)
penalties, or in extreme cases, criminal penalties being
levied against violators. Adherence to procedural
requirements during the inspection and at all subsequent
stages of the enforcement process ensures that evidence
is collected and handled properly and that the rights of the
alleged violator are protected.
After the inspection, the inspector prepares a report on
the inspection, attaching all pertinent documents,
photographs, and laboratory analysis reports. The report is
reviewed by EPA attorneys, assisted by technical experts,
to determine whether violations were found and if there is
sufficient evidence to prosecute an enforcement case.
Then a decision is made about the kind of enforcement
action to be taken, based on the seriousness of the
violation.
For minor violations, such as "paper" or "technical"
violations, a notice of noncompliance is usually issued.
The notice informs the company of the condition that is in
violation and tells the company what it must do to come
into compliance.
For violations of a more serious nature, an
administrative civil complaint is filed. The formal
complaint states the part(s) of the law and regulations that
have allegedly been violated and the facts which support
the allegation(s). The complaint also specifies a proposed
civil penalty amount to be levied against the violator. This
amount is determined by applying the specific penalty
policy for the TSCA rule violated; each penaty policy
discusses how the nature, circumstances, and gravity of
harm are to be considered for all the possible violations of
the rule. The complaint may also propose specific actions
that the company should take to correct the problem and a
timetable for their completion.
-------
Imminent Hazard
and Other Injunctive
Relief Cases
Employee
Protection
The case may be settled or resolved in several different
ways. Since EPA seeks to correct the problem as soon as
possible, attempts to settle the case early in the process
are often desirable. Sometimes, negotiations take place
between EPA and the company prior to a formal hearing,
resulting in a settlement regarding the penalty and/or
corrective action that will be taken. When the facts or the
proposed penalty are in dispute, the case is heard by an
administrative law judge who makes a preliminary
decision on the facts and proposed remedies. The
preliminary decision may be adjusted before a final order
is issued, and the company may appeal the administrative
decision to a federal District Court.
Sometimes an inspection reveals the existence of a
serious situation which would present an irreparable
harm to health or the environment if not corrected
immediately. In such instances, EPA might ask the U.S.
Department of Justice to seek a court order under the
imminent hazard provision of TSCA to compel action to
remedy the problem. To obtain this action from the U.S.
District Court requires a strong degree of proof that
damage is occurring or would occur if the situation were
not corrected. EPA may also ask the District Court for
seizure of the substance(s) involved.
Under another provision of TSCA, U.S. District Courts
may stop a violation of or compel compliance with TSCA or
any of its rules or orders. They may also seize any
substances or articles containing substances
manufactured, processed, or distributed in commerce in
violation of the Act or its rules or orders.
TSCA contains an employee protection clause (Section
23). An employer may not discharge or otherwise
discriminate against an employee who participates in a
TSCA proceeding (such as by reporting possible
violation). If an employee believes he has been
discriminated against, he should file a complaint with
the Secretary of Labor within 30 days of the
discriminatory action.
-------
The mere existence of TSCA (and other toxics-related
laws) does not automatically mean that citizens are now
protected from the dangers of toxic substances. The
regulatory process is lengthy and complex. Deciding the
appropriate means for regulating a toxic chemical requires
careful evaluation of the chemical itself and the impact of
any controls proposed. Furthermore, enforcement of
environmental laws and regulations involves more than
simple implementation of the written requirements.
EPA's enforcement effort is subject to many influences
and constraints. Each year. Congress establishes an
enforcement budget after listening to the Agency's
presentation of needs as well as the arguments of
regulated industry and public interest groups. The
enforcement budget competes with other Agency
programs as well as other national programs.
Consequently, the level of enforcement is linked to
changing national priorities.
Because of its limited resources, EPA enforcement
programs cannot monitor every potential violator of
enviornmental laws and regulations. To make the best use
of limited resources, enforcement strategies are designed
which target compliance monitoring to those areas where
it is expected to have the most impact. The enforcement
actions which are taken as a result of these inspections
are expected to have a dual impact: to bring the violating
company into compliance and to serve notice to others of
the need to comply or risk enforcement action.
In addition to financial constraints, the effectiveness of
enforcement is hampered by the difficulties in gathering
admissable evidence against violators which meets the
standard of proof required. Procuring samples and linking
them to a specific source presents many technical
problems. And proving to the court that the chemical or
problem in question causes actual or potential harm may
be difficult because convincing data regarding health and
environmental effects is largely unavailable.
Citizens concerned about a specific problem should
explore several alternative strategies. In addition to
considering TSCA and other federal statutes, citizens
should investigate state statutes and local ordinances to
determine if they might be applied to the problem. If one
agency is unable to respond because of jurisdictional or
other constraints, there may be another agency that could.
In large agencies, individual departments may differ in
their ability to help.
It is also important to seek relief outside of the legal
system. Courts and bureaucracies move slowly; it may be
advantageous to mount a public education campaign in
addition to or instead of a legal battle. Such a campaign
may put sufficient pressure on the company involved that
it may resolve the situation voluntarily.
-------
How to MakafA/Oood Complaint.
EPA assigns a high priority to citizen
complaints. However, limited
resources make it impossible to
respond to every complaint, so
complaints must be screened to
determined if, when, and how the
Agency will respond. Many times,
when a complaint is filed, the
information given is not sufficient for
this screening to take place. In other
cases, specific locations and
descriptions are not given, making it
impossible to investigate.
A complaint that is timely and
contains detailed information has the
best chance for successful investiga-
tion. To the extent that is possible, a
person making a complaint regarding a
suspected toxics violation should
provide the information outlined below.
Background Information
• Name and telephone number of the
complainant (may be held confiden-
tial)
• Name, address, and telephone
number of the company involved
• Type of business conducted by the
company involved
Physical Description of the Problem
• The exact location of the pollution
• The kind of material seen (e.g., liquid
or solid)
• The color and odor of the material
• The length of time the problem has
been going on
Human Exposure
• Whether the complainant or any
other person has been exposed
• Whether workers in the area are
protected
• Whether the problem is in or near
a residential area
• Whether the problem area is
accessible to the public (e.g., no fence)
Environmental Harm Potential
• Whether there is a barrier to contain
the spill
• Whether there are further pollution
possibilities (e.g., nearby waterways,
wildlife, agricultural production)
Regional Contacts
REGION 1
Air Compliance Section
JFK Federal Building
Boston, MA 02203
(617)223-5610
REGION 2
Toxic Substances Inspection
Station
26 Federal Plaza. Room 1009
New York. NY 10007
(212)340-6669
REGION 3
Environmental Emergency Branch
Curtis Building. 6th and Walnut
Philadelphia. PA. 19106
(216)697-9076
REGION 4
Pesticides and Toxic Substances
Branch
345CourtlandSt.,N.E.
Atlanta. GA. 30308
(404)267-3621
REGION 6
Toxic Substances Office
230 South Dearborn St.
Chicago, IL 60604
(312)886-6002
REGION 6
Compliance Monitoring Section
First International Building
1201 Elm St.
Dallas, TX 75270
(214)729-2724
REGION 7
Toxics and Pesticides Enforcement
Section
324 E. 11th St.
Kansas City, MO. 64106
(816)768-3036
REGION 8
Field Operations Section
1860 Lincoln St.
Denver, CO 80295
(303)327-4137
REGION 9
Air and Hazardous Materials
Branch, Enforcement Division
215FreemontSt.
San Francisco, CA 94106
(415)566-6150
REGION 10
Enforcement Section
1200 6th Ave.
Seattle, WA 98101
(206)339-1090
EPA HEADQUARTERS
Pesticides and Toxic Substances
Enforcement Division
401 M St., S.LW. EN-342
Washington, D.C. 20460
(202)765-0970
------- |