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ENVIRONMENTAL PRODUCT CONTROL
A COMPARATIVE STUDY OF
THE UNITED STATES AND NORWAY
PER A, GULDEN
MAY, 1976
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ACKNOWLEDGEMENTS
I would like to express ray gratitude particularly to
Ms. Dolores Gregory and Dr. I. E. Wallen at EPA, and to
all others at EPA, CPSC, CEQ, OSHA and elsewhere who have
contributed to a very rewarding year in the U.S.
Per A. Gulden
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PREFACE
This review of environmental product control in
Norway and the United States was prepared by
Per A. Gulden during a ten months assignment to
the U.S. Environmental Protection Agency.
Mr. Gulden, a senior official with the Norwegian
Ministry of Environmental Affairs, received support
for the study from Fellowship Program of the NATO
Committee on the Challenges of Modern Society (CCMS)
Office of International Activities
U.S. Environmental Protection Agency
Washington, D.C. 20460
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Table of Contents
1. INTRODUCTION AND SUMMARY
1.1 Summary 1
1.2 Purpose and Scope of the Study 6
1.3 A Brief Look at Environmental Protection in
the TWO Countries 8
2. PRODUCT CONTROL. CONCEPTS AND ISSUES 12
2.1 Product and Environmental Product Control - Definitions 12
2.2 The Need for Control 13
2.3 Who Should Control? 15
2.4 How Can Products be Controlled? 17
2.5 Economic and International Trade Issues 24
3. PRODUCTS WITH CHEMICAL EFFECTS 27
3.1 The Problem in General 27
3.2 U.S.A. 31
3.2.1 Major Legislation 31
3.2.2 Proposed Legislation 38
3.2.3 The Product Control Situation 40
3.2.4 The United States Environmental Protection Agency 44
- Toxic substances 44
- Pesticides 49
- Product Control under the Air Program 50
- Product Control under the Water Program 54
3.2.5 The Occupational Safety and Health Administration 55
3.2.6 The Consumer Product Safety Commission 57
3.3 Norway 60
3.3.1 Major Legislation 60
3.3.2 The Product Control Situation 63
3.4 Discussion 64
3.4.1 Legislation 64
3.4.2 Approaches and Actions 68
4. NOISE ASSOCIATED WITH PRODUCTS 71
4.1 The Problem in General 71
4.2 U.S.A. 74
4.2.1 Major Legislation 74
4.2.2 The Product Control Situation 76
4.2.3 The Environmental Protection Agency 77
4.2.4 The Consumer Product Safety Commission (CPSC) 81
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PAGE
4.3 Norway 81
4.3.1 Major Legislation 81
4.3.2 The Product Control Situation 82
4.4 Discussion 83
4.4.1 Legislation 83
4.4.2 Approaches and Actions 85
5. WASTES RELATED TO PRODUCTS 87
5.1 The Problem in General 87
5.2 U.S.A. 89
5.2.1 Major Legislation 89
5.2.2 Proposed Legislation 89
5.2.3 The Product Control Situation 90
5.3 Norway 92
5.3.1 Major Legislation 92
5.3.2 The Product Control Situation 93
5.4 Discussion _ 94
5.4.1 Legislation 94
5.4.2 Approaches and Actions 95
6. OTHER TYPES OF HAZARDOUS PRODUCTS 97
6.1 The Problem in General 97
6.2 U.S.A. 99
6.2.1 Major Legislation 99
6.2.2 The Product Control Situation 100
6.3 Norway 101
6.3.1 Major Legislation 101
6.3.2 The Product Control Situation 101
LITERATURE 102
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1.1 Summary
For protection of environmental quality, well-planned land
use, and control of pollution from stationary sources will
continue to be of great importance. However, it has become
increasingly evident that this is not enough. Gradually, but
markedly accelerating over the past decade, threats to health
and the environment from a great number of the products we
produce, use and discard have become strongly apparent.
It can be assumed that the greatest hazards are associated
with chemical products, from which long-term effects loom
darker than ever before. Closely related in terms of environ-
mental impact are hazardous wastes, resulting both from the
production and disposal of products. In modern urban society,
noise has become a significant factor in spoiling the quality
of life and causing mental and physical illness. Most of the
noise is caused by products. Some products have a great poten-
tial for littering, which causes visual and sanitary degradation
of urban and natural localities. Modern technology has brought
into use a great many products that produce various types of
radiation, the effects of which are not entirely clear. In the
U.S. and in Norway, as in other western countries, protection
from products with direct health effects has a relatively long
tradition for such products as drugs, food components and
pesticides. The new situation has brought about a rapidly
increasing government involvement in the last few years.
The term environmental product control as used in this study
concerns mainly governmental initiatives or actions taken to
study or reduce detrimental effects to human health or the
environment.
Many governments have enacted new legislation and taken action
to control especially products with chemical effects. Norway
has just enacted a law concerning the control of products
hazardous to health or the environment (June 1976) , which will
be used to prevent any of the mentioned effects. Being an
enabling law, practical action will depend on development of
regulations. In the U.S., a number of laws are used to limit
product hazards in for several types of products, and further
development is anticipated.
The purpose of this report is to provide some information in
view of the increasing general interest in this field of environ-
mental protection, and in particular consideration of the present
interest in this area in Norway. The study broadly describes
the status of product control in the two countries, with emphasis
on U.S. legislation and approaches.
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Chapter 1 draws up the scope and purpose of this study, and
contains very brief outlines of the status of environmental
protection in the two countries and some of the attitudes
that exist concerning such matters.
Chapter 2 contains definitions of some of the major terms used
in the subsequent text. This is followed by a discussion of
some of the basic issues in this field.
Product risk assessment, control of hazards, and coverage of
the accompanying costs should ideally be the responsibility
of the proponent of a product. This is in keeping with the
Polluter Pays Principle, to which OECD member countries
subscribe. The role of the government should accordingly be
limited, preferably to that of a coordinator and supervisor.
The environmental acceptability of products must be evaluated
and secured in the stages prior to marketing, and the assessment
of benefits and hazards should be wide enough to reasonably include
all effects at any stage from production to final disposal. As
a ground rule, the proponent of a product should be charged with
proving that the benefits of a product outweigh its associated
risks.
While public information about the effects of a product will be
a positive and necessary factor in product control, its value
is largely supplemental to more concrete regulatory actions.
Voluntary controls by agreements between government and manu-
facturers or importers seem attractive because of their voluntary
nature, but in most cases such arrangements are impractical and
inadequate for protection. Court rulings establishing liability
on the part of the marketer for damages incurred by his product
are becoming more common, and will instill increased prudence
concerning marketing of hazardous products. The threat of liabil-
ity is an inadequate deterrent against damage, for example where
the effects of a product are delayed or very difficult to discern,
or in cases where the primary damage is inflicted on the environ-
ment rather than on individual health. This has been recognized
in Swedish and Norwegian legislation by specific statements as
to the responsibility of anyone who handles a product, and
explicitly that the marketer of a product must obtain suffi-
cient information about a product to understand its effects.
It is expected that such provisions will inspire the inclusion
of criteria related to health and environmental safety at the
product development stage. Economic incentives and disincentives
have been used to a limited extent to reduce or alter the delete-
rious effects of products. To make such tools truly useful, new
techniques and more experience is needed.
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To limit governmental control activities and costs, the mar-
keter of products must be required to provide relevant informa-
tion for official" use. Chapter 2 also contains a listing of
various regulatory options, and some views on the need for simpli-
fication of relations between marketers and government regulatory
agencies.
Costs to government for control activities are difficult to
assess, but some cost figures are presented. It is even more
difficult to predict costs for marketers of products. Some
examples from the U.S. are included. Costs to industry have
become a big issue in political debate, sometimes obscuring the
fact that the purpose of environmental product control is to
produce a net gain to society by preventing damage.
Chapter 3 concerns products with chemical effects. After a brief
presentation of the types of problems involved, follows a listing
of U.S. laws in this area. Consumer products, and the areas of
pesticides, occupational health, and food, drugs and cosmetics are
covered by new and viable laws. Consumer legislation, in partic-
ular, is quite advanced by international comparison, conspic-
uously lacking is legislation to control toxic substances.
Norwegian laws were inadequate in areas of hazardous chemicals
and consumer products until June 1976, when the new product control
law was passed.
Chapter 3 also gives a brief description of the product control
situation in the two countries. In the U.S., control of chemicals
generally, and in the occupational environment particularly, is
not well developed, but the latter is steadily improving. Con-
sumer products, motor vehicle pollution control, and pesticides
are areas of considerable activity. In Norway, increased activity
is expected in general control of chemicals, in workplace chemi-
cals, and in consumer products.
EPA activity concerning toxic substances is presently limited,
but considerable development of policies and approaches has taken
place. Some of the most important issues are reviewed. Chapter
3 also includes a brief description of EPA's pesticides program.
More detail is spent on EPA's motor vehicle emission control pro-
gram, which well illustrates the complexity of technical and
regulatory problems of product control. EPA's programs for con-
trol of fuels, fuel adc^tives, drinking water and oil dispersion
agents are also briefly described.
The Occupational Safety and Health Administration's (OSHA) program
on hazardous chemicals is being developed, and the body of stand-
ards is presently imcomplete. There will be significant problems
of compliance monitoring and enforcement.
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The Consumer Products Safety Commission (CPSC) reacts to hazards
reported in an extensive injury reporting system, and employs a
number of powerful and uncommon control optipns.
Both countries have chosen regulatory restrictions as the primary
approach to control of products. Control efforts in the U.S. take
place in a very polarized atmosphere, where various actions by
industry seem to obstruct prudent and sensible actions by agencies.
Agencies are often in the position where they have to prove that
a product is hazardous before action can be taken, in spite of
express legal requirements concerning industry's obligation to
provide test data. This is especially pronounced in the pesti-
cides and food additives area, and reflects an ambiguous situa-
tion concerning the "burden of proof."
Chapter 4 deals with noise associated with products, and starts
with a brief introduction to the problems of noisy products. The
U.S. has advanced legislation concerning control of noise from
products. Performance standards will considerably improve noise
conditions. However, certain use restrictions may be required,
and authority for use control rest with the individual states.
The new Norwegian law will provide an adequate basis for regu-
lating noise from products.
In the U.S. it is still too early to assess the effects of regula-
tions, but substantial improvement must be expected as noisy
products are replaced by quieter ones.
The EPA noise program has produced valuable information on the
nature of noise hazard and control technology, and a number of
regulatory techniques have been developed. Because of its many
interesting aspects, the program is described in some detail.
CPSC's noise program is largely incidental to the concern for
safety, and is only briefly mentioned.
The information and techniques developed is the U.S. noise programs
will undoubtedly be useful to other governments, and cooperation
possibilities should be studied.
Following a brief discussion of some of the environmental aspects
of waste and litter, Chapter 5 continues with a presentation of
relevant legislation. Provisions for product control to reduce
problems in this area are virtually non-existent in the U.S.
federal laws, although several bills have been proposed over
the years. Norway had limited legislation amenable to reduction
of waste and litter from products before the new product control
law was passed, and activity in this area has been low.
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Generally, problems with hazardous wastes, and with the quantities
of waste and litter tend to be greater in the U.S. than in Norway,
but there are, of course, local deviations from this.
It is expected that initial U.S. regulatory actions will
be more directed to handling, disposal and recycling rather
than product control measures to influence quantity, or
design or composition of products to reduce environmental impact.
In Norway, efforts to enhance waste separation and biodegrad-
ability, and to reduce waste by use of return systems and
standardization are likely to be undertaken. These are fields
where the use of fees may be meritorious.
Other products which give rise to hazards such as radiation,
inaudible sound, light, heat, etc., or may be dangerous by virtue
of their electrical, explosive, flammable or mechanical properties
are treated in Chapter 6. Some of such hazards have environmental
significance, some products may exhibit such hazardous properties
in combination with those dealt with in the previous chapters.
The chapter describes some of the problems in these fields. Con-
trol of many such hazards has been established in the U.S., and
particularly advanced systems have been developed for consumer
products. While flammable textiles have been inadequately dealt
with in Norway, quality and safety control of electrical products
is good. The new product control law will presumably cover all
of the mentioned types of hazards.
Much of methods development and regulatory work done in the U.S.
concerning consumer and other products will be of great value to
other governments.
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1.2 Purpose and Scope of the Study
This study concerns the ways in which society, largely through
actions by the federal or national government, protects the
individual and the environment from adverse effects of products.
In the U.S. and Norway, as in other western countries, protection
from products with direct health — and safety related effects
has a relatively long tradition, as for example drugs, food
components and pesticides. But in the later years, with the
advent of new environmentally significant chemicals, the pro-
liferation of noisy products, products responsible for high-
volume littering and other waste problems, an enormous variety
of consumer products and sophisticated electronic products, it
has become important to develop prudent protection mechanisms
to cope with this new situation.
In recognition of these circumstances, a Norwegian law on prod-
uct control was passed by Parliament in May 1976. During prep-
ation of the bill it became clear that more than ever before,
a comprehensive approach is needed — an approach to assess
the total societal benefits and costs at any or all stages in
the "life cycle" of a product, the multiple effects of a product,
and its combination effects with other products. The bill was
designed to enable the government to act according to such
principles, and regulate where needed on the basis of broad
enabling powers.
The development of such regulatory capabilities requires inputs
of information and experience from related activities elsewhere.
It is the purpose of this study to contribute to such prepara-
tions by providing a closer look at some current laws and activ-
ities in the U.S., where certain areas of product control are
well developed.
A brief presentation of Norwegian legislation and activities
will provide a wider frame of reference for some of the specific
topics in the study. Also, such information on Norway will
show some of the background for the government's initiative
in product control, and may be useful in conveying some of the
principal ideas to other countries which may be in a similar
situation.
The scope of the topic of product control is very wide, and
certain areas have been selected for discussion in this report.
Those areas where western countries have a developed tradition
such as drugs, and food are not covered; pesticides and issues
relating to the occupational environment only briefly.
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There is a general emphasis on product types with environmental
significance and those which represent current issues in Norway.
However, these lines are deviated from in cases where certain
principles or strategies deserve special attention in relation
to the product control concepts which are discussed. Most detail
is devoted to descriptions of certain advanced U.S. programs,
because this will be particularly useful as background information
for planning new product control programs.
The study will also shed light on some of the important current
product control issues for the benefit of general interest.
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1.3 A Brief Look at Environmental Protection in the Two
Countries
The U.S.A.
The abundance of natural resources has brought the U.S.
to a level of use of energy, materials and environmental
resources which is unparallelled. Growing environmental
concern and protective action have not kept up with mate-
rial development, and considerable environmental deteriora-
tion has taken place over the last 20-30 years. Over a
relatively short time span, from the mid-sixties until the
present, the momentum of environmental responsibility has
increased to make it a considerable political force.
In the latest years good progress has been made with the enact-
ment of new legislation in the areas of pesticides, air and
water protection, occupational health and consumer protection.
There is strong activity in enforcing the legislation.
At present, there seems to be a temporary culmination of the
efforts. This is indicated by events such as the failure
of Congress to legislate land use planning, strip mining,
waste control, and toxic substances, after prolonged political
battles. Congress almost decided to ease controls on pesticides
by returning certain authorities to the Department of Agriculture
in 1975. The delay in fulfilling the ambitious, but necessary,
goals for vehicle emission reductions seems to be largely
politically motivated.
/
These cases may be repercussions of acute energy shortages,
economic recession and unemployment. If so, activity could be
expected to recover as some of these problems now show some
sign of improvement. However, the increasing hunger for greater
energy consumption will be a most important factor and possible
obstacle in the climb towards environmental improvement.
There are also a number of other factors that tend to obstruct
environmental improvement in the U.S. One hinges upon the
relationship between the states and the Federal government,
wherein the states' individual interests tend to make a federal
consensus difficult to achieve. The essence of this problem
lies in such factors as differences in political climate,
economic and industrial development, varying conditions of
local environments, and a general waryness of federal influence
on the local level.
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Another problem is that U.S. society has reached such a level
of material maturity that deeply entrenched consumers' habits
and strong vested economic interests will provide great inertia
against change.
Strong industry influence is present at all political levels,
and heavy lobbying pressure on members of Congress is one
manifestation of this. Industry is also believed by many to
have considerable influence on administrative decisions, and
also makes frequent use of the courts to refute or defer agency
decisions.
On the other hand, public concern and awareness of the environ-
ment seem to be increasing. One issue very much on peoples'
minds right now is the need to reduce the risk of cancer caused
by environmental factors. There are a number of serious and
vocal consumer and environmentalist groups which also influence
politics and administrative actions through the courts. How-
ever, their economic resources in no way match their "opponents.1
A most significant milestone for Federal efforts toward
environmental improvement was reached by the passage of the
National Environmental Policy Act of 1969, which requires
Environmental Impact Statements for any project with federal
involvement and directs each Federal Agency to incorporate
environmental considerations into its decision making process.
The Act established the council of Environmental Quality
responsible for studying the condition of the Nation's environ-
ment, to develop new environmental programs, to coordinate
Federal environmental efforts, and seeing that Federal activ-
ities take the environmental considerations into account.
The Council recommends national policies to the President.
In 1970, the Environmental Protection Agency was created to
carry out the national environmental policies. The Occupational
Safety and Health Administration and the Consumer Product Safety
Commission, as well as the Food and Drug Administration, are
powerful factors in the national quest for a safer environment.
As in most other countries, environmental considerations are
generally regarded as a necessary add-on to economic and
material development rather than a limiting frame within which
such development may take place. The emphasis is on growth in
materials and energy consumption, tempered by environmental
consideration. There are no direct regulatory efforts to
conserve energy and material resources.
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Development of environmental protection in the U.S. is likely
to have significant impact on environmental actions abroad
and internationally, both because of direct influence on a
great number of factors, and by more passive example.
Norway
Although highly industrialized, environmental deterioration
is generally less evident than in some areas of the U.S.
However, grave local pollution problems exist due to industrial
developments and population concentrations. Many of the environ-
mental problems existing in the U.S. can be identified also in
Norway, although the number of chemical pollutants is likely to
be less.
The bulk of these problems developed with the rapid industrial
expansion after the second World War. The southern part of
the country also receives significant air pollution (acid rain
and heavy metals) from middle European countries.
Norway has one of the world's highest per capita consumption
of energy, but thanks to hydroelectric power this has not
significantly affected the environment. Even though the
standard of living is high, the material consumption per
capita is relatively smaller. The chemical industry producing
hazardous chemicals is also relatively smaller, but will be-
come more significant as Norway enters into petrochemical
production. Domestic production and products, as well as
imported products create problems in the work place and are
potential threats to general health and the environment.
Many of the environmentally significant products are imported,
and this may make adequate protection somewhat easier to
achieve since restrictions will have less direct impact on
local industry or employment.
There seems to be a general consensus about the importance of
environmental protection, and administrative decisions in the
area are not made in the type of adversary climate that often
prevails in the U.S. in the chemical products area. However,
present and imminent problems should not be underestimated.
They will continue to grow with increasing production and
consumption. Increasing protection from chemical and other
products is clearly required.
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The Ministry of Environment was instituted in 1972, and has
responsibility for land use planning, nature conservation,
resource management and pollution control. The State Pollu-
tion Agency is a parallel to the Environmental Protection
Agency, but its scope is more limited. Control of pollution
from industry and municipalities is progressing in a method-
ical way. Responsibility for control of other pollution prob-
lems also rests with the state authorities for health, occupa-
tional health and agriculture. Environmental protection
authority is rather centralized, but authorities concerning
municipal sewage and solid waste have been delegated to the
counties.
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2. PRODUCT CONTROL. CONCEPTS AND ISSUES
2.1 Product and Environmental Product Control - Definitions
In the Norwegian law on product control, "product" is a
wide term which covers any item or substance at any stage as
raw material, auxilliary, intermediate or finished goods. In
this study, "product" will generally be used in the same way.
When used in the context of specific laws, actions or programs,
the term will take on a correspondingly limited meaning.
For the purpose of this study, the term "product control" will
apply to any action aimed at reducing adverse effects on health
or the environment, either directly or indirectly associated
with a product. The study deals with governmental initiatives
in product control, and therefore industry or citizen efforts
will be touched upon only to the extent they compliment govern-
ment programs. Product control may take on a variety of forms,
such as direct regulation by law, economic insentives, informa-
tion campaigns, and voluntary restriction agreements.
Product control measures can be applied at any stage of a
product cycle — production, distribution, use, waste disposal
or recycling. The measures may affect many types of product
related activities, such as production methods, handling, trade
protection precautions, storage, packaging, labeling, use,
testing and assessment of the effects of products.
In this study, "health effects" means any weakening of physical
or mental health. Mental health is regarded only in relation
to pollution, noise, visual pollution and odor, and not such
things as subversive information media products. "Environmental
effects" refer to problems caused by pollution, wastes, noise,
radiation, etc.
Product control concepts may be used to protect or manage
natural resources. While this study does concern the care of
environmental resources, it does not address the problems of
protecting non-renewable or contingently renewable resources.
However, when product control measures are applied to protect
against hazard to health or the environment, improved resource
economy is sometimes an accompanying benefit.
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2.2 The Need for Control
Environmental problems may be countered in basically three ways:
First, we can reduce the negative effects of local pollution or
noise by separating the associated activities from other activ-
ities which we wish to protect. In other words, we can remove
ourselves from the most severe nuisance. This can be accomplished
by land use planning. Although available space limits this
type of solution, it must still be used where other solutions
alone are insufficient, such as with airport and road noise.
Secondly, pollution is controlled by reducing discharges and
emissions from stationary sources such as factories, power
plants, and urban areas.
However, problems arising from products (or other activities
related to them) are constantly taking on more significance.
Health problems caused by products have long been under some
form of control in many countries (pesticides, drugs, explo-
sives) , and product control in this sense is therefore not a
new concept. The environmental significance of products, and
the environmentally mediated health effects, has become a matter
of concern over the last few decades. Control of products to
reduce such problems are presently inadequately established.
Product control to reduce environmental and health hazards
represents the third important thrust in environmental pro-
tection.
It is common to apply isolated corrective measures to reduce
adverse effects related to products where they are most evident --
emission control, worker protection, consumer protection. But
it is very rare that all the hazards and societal costs are
viewed together to give a true picture of the impacts attribut-
able to a particular product. The concept of product control,
when applied to full advantage, will enable society to raise
the entire question of the net societal value of the product
and related activities. Instead of the traditional piece-meal
corrective approach, it should be possible to list all risks
and societal costs related to a product from genesis to
final disposal, and all corresponding benefits, and select
the appropriate controls on this basis. (Or, the comprehen-
sive assessment may lead to the conclusion that, all factors
considered, society can do better without the particular pro-
duct) .
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Product control authority completes the basis needed for
society to set optimal environmental protection priorities
and choose the best means for fulfillment.
The need for control of products will be further discussed
in the following section, and in the sections referring to
the general problems caused by products.
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2.3 Who Should Control?
Ideally, the proponent for the use of a product should make
sur'e that it does not directly or indirectly cause harm to
any person or our environment. Since not many products are
entirely safe or cannot be made entirely safe, accomodations
of this principle must be made. However, it remains a reason-
able and equitable principle to observe whenever practicable.
It may be argued that in a free enterprise system where the
user has the free choice, the market will automatically discard
hazardous products and support the safe ones. Also, the fact
that a particular product can be sold, proves that the benefits
are higher than the risks. And in order to operate in such a
market, the marketer must always have a first hand knowledge
of his raw materials, be aware of intended or unintended compo-
nents in the product, and fully understand any health or environ-
mental effects in order to be able to offer a competitive product.
The argument is partly valid, but often there is little incentive
to carry the assessment any further than to those properties of
the product which are readily understood by the buyer. Therefore,
the marketer will often not sustain the capability to assess the
effects of a product on the environment or more subtle long-term
effects on human health. There is reason to believe that this
incentive is becoming stronger as more court rulings point to
the liability of the marketer, but past experience does not
guarantee that market self-regulation is satisfactory.
Even if the attitudes of society and the individual user were
to become more strongly critical, there are several reasons
why self-imposed control on the part of the marketer may not
be sufficient. For one, there are the delinquents who do not
disclose subtle hazards and thus go undetected without any kind
of control. Further, even thorough testing may sometimes not
reveal certain long-term effects. In such cases broad epidem-
iological reveiw may be the only possible method of detection.*
Due to the volume and confidentiality of health data, such
surveys may not even reasonably be expected of the marketer.
There is also the fact that although some large companies will
develop considerable expertise in assessing the effects of
products, some of the smaller producers may never attain a
*Epidemiologic findings imply that certain effects may have been
suffered. Such retrospective fault-finding should hopefully be-
come less necessary when adequate pre-market control is established,
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satisfactory competence. And since there may be a vast number
of sources of environmental contamination, no one marketer has
the possibility of evaluating the incremental environmental
impact of his particular product. For these and similar
reasons, several countries have concluded that some govern-
ment control must take place.
However, virtually millions of different products are traded in
the market today, and a great number of new products are intro-
duced every year. It will be impossible for any government to
act as overseer of the hazardous effects of all these products.
This points clearly to the need for industrial involvement in
the assessment and curtailment of hazardous effects. Such ac-
tions will add to the burden of demands and contraints on indus-
try, and may at first hand seem to be undesirable for that reason.
Nevertheless, this is the only practical solution, because other-
wise an enormous bureaucracy would have to be supported from
public funds. Such a solution would also mean that a large num-
ber of tax payers would have to contribute to the control of
products from some of which they gain no advantage.
The basic idea that the person who benefits from the marketing
of a product should also pay the costs of minimizing risks, is
also embedded in the polluter pays principle which is formally
adopted by the OECD member countries. This means that necessary
control actions should be carried out by the industry. With
few exceptions, these costs will be passed on to the user, who
in turn is the right person to pay since he benefits from the
product in question.
A final reason why industry should do as much as the work
involved in product control as possible, is the fact that
industry by necessity accrues a considerable amount of
information before marketing of the product takes place.
The party in possession of this information is clearly at
an advantage to make assessments.
In conclusion, the largest efforts in assessing and reducing
the risks from products should be made by the marketer. Govern-
ment control, although necessary, must be kept to a minimum. The
government should primarily take the role of overseeing measures
taken by the marketers and supplement these where the marketer
does not have the competence or cannot reasonably be expected to
perform the complex tasks needed for adequate control. But even
such a minimal government role may amount to a considerable effort.
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2.4 HOW Can Products be Controlled?
Pre-market Control
Experience gives ample evidence of unwanted effects of products
caused by lack of knowledge, neglect, or basic conflicts of
interest. In many cases, corrective action is taken only when
the damage is done and the effects are evident, with little
relief to those who already suffered. Many of the problems
could have been avoided had the effects been adequately
assessed before the product was marketed.
The need for pre-market assessment has long been evident in
pesticides, where effects can be so obviously horrible. Be-
cause of the sinister, long-term effects of a great number
of chemical products, many governments now see the need for
pre-market assessment and strong restrictions. The general
concept of pre-market control does not only apply to chemical
products, it must be effectively used on products that create
waste, noise, radiation and other hazards.
Adequate assessment and control of products before marketing
to avoid hazard to health and the environment, loss of invest-
ment or jobs, is a most important principle to be adopted in
product control policy.
Public Information
Government's role in product control can take many forms.
The mildest form would be to restrict activity to public infor-
mation. It is sometimes argued that most problems stem from
improper use of products, and that good information could elim-
inate problems to a significant degree. A government body can
review the assessment made by the marketer and require appropri-
ate warnings and directions for use and disposal. It is clear
that this role is inadequate for many product types, and it will
be more so as effects and use patterns become more complex. How-
ever, information is an important tool in product control where
stronger measures are not required, or it may supplement other
measures.
Voluntary Controls
It is also argued that adequate protection could be ensured
by voluntary agreements between marketers and the government,
while achieving minimal interference with market processes.
This may be a solution in some cases. But just as the marketer
would be free to enter into an agreement, he would be equally
free not to do so. In very many cases it will to totally
impracticable to establish agreements with all parties which
have responsibility in producing or marketing a product. Simi-
lar difficulties will arise in cases where it is necessary to
control the uses of products.
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Liability and Responsibility
In many countries, the marketer has certain responsibilities
towards the user for malfunctioning or for damage caused by
a product. However, to collect damages or to punish a marketer
for alleged lack of responsible precaution on his part is a
lengthy and uncertain undertaking. This is partly due to the
difficulty of establishing an evidential relationship between
the product and ill effects, and partly due to lack of clear
cut liability rules. More often than not, responsibility does
not extend to cases of environmental damage and subsequent
damage to human health. While increased liability in relation
to products will increase general awareness, it will not per
se become adequate as a protection mechanism. However, it may
be a valuable component in a larger product control system.
In observance of the need to obtain maximum participation by
marketers in the total product control effort, the Swedish
and Norwegian product control laws expressly establish marketer
responsibility to acquire sufficient information about a product
to judge health and environmental effects. For products which
have been in use for some time, and whose effects are thought
to be understood, a marketer should at least acquire generally
available information, and be alert for indicators which should
initiate further investigation. In the case of new products,
the marketer should have a more active obligation to assess
the risks. The assessment should not only include his own
handling of the product, but must to a satisfactory degree take
into account effects caused by intended uses, and as far as
possible also unintended uses.
An obligation to acquire a certain amount of knowledge should
be extended to those who handle a product professionally.
Under certain circumstances where considerable analysis is
required, a procedure modeled after U.S. Environmental Impact
Statement* procedures should be considered.
In practice, information requirements will lead to increased
effort on the part of the marketer or those who handle the
product professionally to take the necessary steps to minimize
risks. The producer will increasingly add to such present
product product development criteria as efficacy, reliability,
durability, safety and aesthetics, criteria intended to reduce
adverse health and environmental effects, other safety hazards,
or potential to create litter or excessive or undesirable wastes
Since it will be impossible for government agencies to look at
every product, a clear obligation for the marketer to acquare
knowledge will be very important. If sufficient guidance and
proper enforcement are provided, such requirements will be very
useful in a product control program.
*According to the National Environmental Policy Act, see
section 1.3.
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Economic Incentives
The use of economic incentives or disincentives in product
control has been the topic of much discussion. Taxation
could be useful when the objective is to reduce the quantity
of a product used without having to resort to outright restric-
tions. Taxation does not directly restrict the choice of pro-
ducts (although the economic situation of the buyer is of
importance). Taxation will also tend to inspire the producer
to develop substitution products which have less undesired
effects. Taxation may also have an advantage over legislative
regulation in that it involves less administrative work, partic-
ularly with regard to enforcement. It is also argued that taxa-
tion may lead to quick results, and that it is a flexible tool
that can be easily adjusted to suit the intended purpose.
However, there are few examples of taxation for environmental
product control purposes. Norway has a tax on non-returnable
beverage and beer containers sufficiently high to significantly
reduce sales. There is also a tax on the sulphur content of
fuel oil used in industry. In the U.S., an energy policy bill
contains interesting provisions for a penalty on a sliding
scale on cars that do not meet energy efficiency standards,
and a corresponding credit for cars that perform better than
the standard.
One of the problems of using taxation for environmental product
control is that it is apparently difficult to determine the
optimal rate at which the desired effects are achieved. Tax
rates can be adjusted according to feed-back information on
environmental quality but rate changes create new situations
for marketers, whose patience may be understandably strained
by repeated adjustments. Because taxation leaves the marketer
with several options, it may be difficult to predict not only
how much effect a tax rate may have, but also what kind of
effects. Indeed, some unexpected effects may turn out to be
less desirable than those which the taxation was intended to
alleviate.
Thus, taxation may well be a flexible tool, but also a slippery
one.
Taxation will not be useful in controlling very toxic products,
or for example cancer-causing products. In political terms,
taxation seems to become increasingly unpopular. Nevertheless,
as experience with economic incentives develops, they may
become increasingly important.
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Regulatory Control Options
Regulatory control of products may be very complex and requires
a broad set of flexible regulatory tools. These tools must be
adequate to handle both acute problems and suitable for a
systematic long-term effort. The degree of regulation must
reflect the severity of the problem to be abated, and this
calls for a graduated scale of regulatory options. Some
products must be treated as individual cases with specifically
tailored restrictions. In general, however, generic approaches
to groups of products will be preferable.
There will be cases where regulations will apply to certain
geographic areas or limit the number or categories of persons
trading or handling a certain product.
Among the more common regulations will be requirements for
labeling to inform or warn the user, or labeling and packaging
requirements for safer handling, use or disposal.
To reduce hazard or environmental disturbance from products,
regulations may be applied to change the composition or design
or to set limits for emissions of pollution, noise, radiation,
etc. Similar regulations may be designed to reduce waste and
litter, and deposit and return requirements may be set for the
same purposes.
In-use requirements for products are important in product
control. Rules may be issued as to how, how much, where,
when and by whom a product may be used. A manufacturer
may be required to take responsibility for product compli-
ance over the lifetime of the product, and the user may be
prohibited from modifying the product in ways which would
violate regulations.
*
For particularly hazardous or otherwise important products,
registration and permit systems may be set up. As condition
for granting permits, any of the mentioned requirements could
be applied, or amounts produced or sold could be limited.
In some cases where the risks greatly outweigh the benefits,
and where no other restrictions are satisfactory to prevent
unreasonable hazard, it is necessary to prohibit marketing
or use.
Other product control-related actions are: inspections to
obtain information or to enforce rules, temporary bans on
products where imminent serious hazard is suspected, seizure
of products not in compliance, requirements on the marketer
to inform the regulatory agency or his customers of suspected
hazards with his product and to recall products or compensate
buyers for the value of the product.
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Several types of legal sanctions are in use in relation to
existing product control schemes.
Primary concerns in promulgation of regulations are to make
them self-enforcing to the highest possible degree. This may
be achieved by such methods as self-reporting, information
and record-keeping requirements.
An overriding concern with regulations is to make them simple
to promulgate, simple to comply with, and simple to enforce.
It is now common to attempt this by setting performance
standards on products — advising what a product should or
should not do — rather than dictating how desired properties
or functions can be achieved.
Comprehensive Approach
The question of comprehensive assessment and subsequent selection
of optimal corrective measures was introduced in section 2.2.
Traditionally, the impacts of products and related activities at
various stages have been assessed and regulated by completely
separate authorities. Coordinated action has been obstructed by
missing, or narrowly specialized legislation. To permit compre-
hensive assessment and optimal control actions, it is important
that product control legislation be made sufficiently wide, and
that administrative mechanisms are set up to ensure adequate
coordination.
Burden of Proof
How to make good assessments of risks and benefit is a very
real problem. The negative effects are sometimes very difficult
to predict due to severe limitations in the present state of the
art. Also, it may be difficult to know how, and to what extent
a new product will be used — both important factors for esti-
mating risk.
To assess the risks is difficult, to assess the benefits is
often no less difficult. An example could be the pesticide
DDT. At the time of its introduction, little systematic
assessment had been done, the effects have become evident over
time. It is said that today, a large portion of the world's
population indirectly relies on DDT for food supply and for
protection against certain tropical diseases, to an extent
probably not conceived of when the product was marketed. Had
an assessment been made *t that time, it is possible that DDT
would have been severly restricted or held off the market.*
*While the merits of DDT are still being argued, the example does
indicate problems of predicting both benefits and risks.
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Because we are not equipped to make predictions of effects with
complete certainty, there will always be doubts. In legal think-
ing, and according to administrative practices in the past, the
benefit of the doubt should go to the proponent of a product.
In other words, if the product cannot be proven to be hazardous,
it would be unreasonable to interfere with the producer's right
to market it. In the present situation of scientific uncertainty
concerning the effects of products, it will be necessary to de-
part from this interpretation of the principle. In the interest
of societal protection the burden of proof in relation to certain
products must be laid on the shoulders of the marketer. He must
prove that the product provides a net benefit, and if it cannot
sufficiently be proven, society must have the powers to restrict
or ban that product.**
Information Requirements
In order to take an active part in product control, governmental
agencies depend on large amounts of information. The information
developed by producers will often constitute the bulk of infor-
mation required for government assessment and regulatory action.
In order to avoid duplication of efforts and reduce the costs of
government product control, it is reasonable that industry be
required to submit information, either on a case by case basis
or according to some predetermined format. Mandatory disclosure
to government bodies is required in several countries, especially
concerning economic poisons and drugs. Requirements on industry
to produce information and disclose it to regulatory authorities
is most important in environmental product control.
Problems of Over-Regulation and Over-Administration
Marketers of products are facing increasing restrictions and
controls -- some of which have become accepted as necessary
evils. Environmental protection measures are among the latest
additions to the list, and are still often regarded as obstacles
to industrial activity rather than considerations which should
be naturally included in the course of activities. While
perhaps no one would disregard the need for protection of health
or the environment from effects of products, increased product
control for such purposes will be met with a fair amount of
resistance. A common complaint against environmental regulations
is that they are often too complex and restrictive. There is
**This principle is applied to pesticides, drugs and food addi-
tives.
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no doubt about the general need for regulatory action, nor about
the complexity of the issues. (As an example, the U.S. Environ-
mental Protection Agency (EPA) anticipates that it will require
about 90 persons and several million dollars in contracts to put
out necessary regulations for three chemicals in the average
year). There is no easy solution to the problem of complexity
of regulations, but a consciencious effort must be made to
simplify as far as possible.
Another factor of concern to the industry is the need to deal
with sometimes large numbers of government bodies for various
types of permits or information. In some countries, a manufac-
turer may have to clear separate environmental permits for dis-
charges to air, water, for waste disposal, for noise, for
occupational hygiene, and land use zoning regulations. Depend-
ing on the product to be produced, it may become necessary to
obtain permits from different authorities regarding for example
human health, the environment, and consumer affairs. It must
be a primary concern to minimize such administrative problems.
Existing legislation is often not conducive to simplification
efforts, because laws address limited number of products or
effect types, and the agencies responsible are similarly limited
in scope. Solutions must be found so as not to unduly limit
the creativeness of industry, and to avoid overlapping or con-
tradictory decisions by government. In some cases, the revisions
of laws and subsequent consolidation of agencies may be the answer,
in other cases inter-agency cooperation is the best answer.
The dilemmas of an increasing governmental role as overseer
may best be pictured by such current terms in U.S. debate
as: accountability, predictability, credibility, objec-
tivity, and self-perpetuation of government agencies. Who
is really accountable for decisions, and are individual
interests sufficiently protected? How can agency actions
be predicted, so that industry may have time to adjust? And
is the scientific basis for decision adequate and used without
prejudice? There are no easy answers. Unnumbered actions and
changes in attitude must together contribute to acceptable
solutions.
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2.5 Economic and International Trade Issues
In economic terms, the purpose of environmental product control is
to produce a net gain to society by preventing damage to health and
environment. This net gain is the difference between the benefits
and the costs. (The costs include damage caused by a product, as
well as direct costs.) The magnitude of these items depend on what
the specific problems will be, the level of activity undertaken to
counteract them, and the influence of foreign trade relations,
among other things. Therefore, at this point, it is only possible
to make general statements relating to some of the important eco-
nomic factors. The costs may be divided into two categories, (1)
concerning direct costs of government and private involvement and
(2) the micro-economic effects.
An order-of-magnitude of governmental expenditures may be indi-
cated by looking at figures for largely new efforts as planned
by the Norwegian government. Excluding pesticides control and
supportive research, and expected to increase substantially over
a few years, the estimate is about U.S. $0.15 per capita per
year. Costs in Sweden are of the same order of magnitude. In
the U.S., the EPA Office of Toxic Substances' funding under
future legislation may be around $0.15 per capita per year.
Corresponding figure for the EPA pesticides program is about
$0.23.
Major cost items for producers will be for gathering information,
testing and assessment. Large companies already do considerable
work in these areas, and the average additional expenditures can
generally be expected not to be disruptive. Some large companies,
and in particular a greater number of smaller companies not pres-
ently equipped for these tasks will in some cases experience
significant costs impacts.
In the U.S., attempts have been made to calculate direct costs
to industry following adoption of the Toxic Substances Control
Act (TSCA). The Manufacturing Chemists Association (MCA) sites
figures ranging from U.S. $360 million to 1,300 mill, per year,
EPA figures range from $80 million to $140 million. The wide
range of each set of figures and the overall difference of
almost a fact of 10 reflects uncertainties and different pre-
sumptions. On a national per capita basis, these figures vary
from $.40 to $6.50. In the latter figure, almost one half is
attributable to assumed loss of profit as a result of control-
initiated decrease in industry new product innovation, and the
rest seems somewhat inflated on the presumption that government
actions will be concluded on a sweeping unselective basis.
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In some cases, production or marketing may be postponed while
further tests or assessments are carried out, and this may
mean loss of return on capital invested in production or market-
ing. Such costs will again tend to have stronger effects on
small marketers with a limited number of product categories.
While such costs can not be avoided in some cases, close coopera-
tion between industry and control agency will help.
When government product control actions reduce or halt the sale
of product or require changes in processes of products, invested
money may be partly or wholly lost. In cases where changes can
only be made at high cost, reasonably extended periods of trans-
ition may ease the economic effects. More and more, it will be
important for marketers to make early and thorough assessments
to avoid such effects, and for the government to signal indica-
tions of potential problems as early as possible.
A general cost-benefit analysis must expressly or implicitly be
made in connection with product control decisions. The problems
are well known: economic costs must somehow be weighed against
values which often can not be expressed in economic terms. Since
this may be exceedingly difficult to do in compatible unit terms,
a reasoned judgement must be made. Here, costs of health care,
loss of productivity, environmental cleanup and waste handling costs
must be considered. Imperfect as cost-benefit analysis techniques
may be, they are nevertheless useful for indicating relative merits
of control actions. It must also be remembered that trade-offs be-
tween economic and other values are implicit in almost any polit-
ical decisions in any other area. Such trade-offs are in other
words not peculiar to environmental politics.
The costs of control measures to be born by manufacturers are
normally included in the price of the products and passed on to
the consumer. As compared to the sum of all fixed and variable
costs items that make up the price of a product, it is generally
assumed that the additional cost increment caused by control mea-
sures is relatively small on the average, but there may be notable
exceptions. Normally, such factors as fluctuations in costs of
raw materials, energy and labor will be more significant than
product control costs. Ideally, such cost should be directly
reflected in the price of the product concerned, for reasons
mentioned in connection with taxation as a product control tool.
In practice, the marketer will have the option of distributing
some of the costs of control to some of his other products.
Estimates by EPA and MCA conclude that the inflationary impact
of the Toxic Substances Control Act (TSCA) will be very small.
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Increased product control measures may present more problems
to small marketers with limited assessment capability than
to larger broad-based companies, and this may increase the tendency
for small firms to merge. This tendency could to some degree
be counteracted by cooperative efforts between small marketers
by way of improved information and common testing facilities.
Employment dislocations resulting from product control measures
are extremely difficult to estimate because there are several
more significant factors that determine the employment situation.
Again using the above mentioned studies as examples, the EPA
estimates that the TSCA will not cause a net increase in unemploy-
ment, whereas the MCA estimate is between 20,000 and 80,000 jobs
lost in the U.S. over a 10 year period.
Dislocations in international trade is an aspect that must be
considered as a result of product control actions. If the
price of a product is significantly increased by product con-
trol requirements in one country, the product will be less
competitive in international markets. It is important that
such effects be minimized by international cooperation. Organi-
zations such as the OECD and the EEC are working towards this
end. EPA estimates that the balance of trade will not be seri-
ously effected, whereas MCA predicts a reduction in the trade
balance of up to 25% caused by declining sales of chemicals
alone.
In some cases, different requirements for products for domestic
and foreign use could be considered. For example, there may
be cases where it is justifiable to use a certain product in
one country and not in another. The question of unequal product
requirements in countries also becomes a problem when a country
with lax requirements tries to sell products to a country with
stricter requirements. A refusal to import a product on such
grounds may in some cases violate trade agreements. Generally,
EEC, EFTA and GATT rules expressly permit import restrictions
resulting from measures taken to protect health or the environment.
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3. PRODUCTS WITH CHEMICAL EFFECTS
3.1 The Problem in General
Products with chemical effects are likely to be the most impor-
tant category in terms of hazard to health and the environment.
And possibly the most difficult to understand and control.
The number of chemicals, and the volumes used, have increased
at an accelerating rate mainly within the last 80-100 years.
It has been estimated that today some 2 million different chem-
ical substances exist, most of which are of synthetic origin,
and that this figure is increasing by some 20,000 new substances
every year. The number of chemicals in the market is assumed to
be about 200,000 and 200 to 500 new chemicals are introduced
each year, mostly without systematic assessment. These sub-
stances are used in a far greater number of commercial products.
Most of these substances will be reasonably safe as they are
presently used, but many have known hazardous qualities,
and others are suspected. Also there are examples of substances
previously believed to be safe, which have turned out to be harm-
ful after closer investigation.
Although some organisms have shown ability to adapt and thus
protect themselves against chemicals (such as certain insects
against certain pesticides), it is obvious that we cannot count
on such protection even against minute quantities of the great
number of chemicals we are exposed to. While knowledge remains
incomplete, it is suspected that maybe 70% - 80% of cancer
cases are caused by some kind of environmental factors, a
great portion of which are assumed to be linked with chemicals.
The potential for harm depends on chemical and physical properties
of the substance, concentration, the magnitude, type and duration
of exposure, and may vary from individual to individual. The
damaging potential of a chemical may increase to a surprising
degree in the presence of another substance.
Acute poisoning, evidenced by ill effects after a short period
of time, is relatively well understood. Many such cases are
results of careless or unqualified handling of a product, and
such accidents may to some extent be avoided by better packaging
or labelling, restricted use, and other means. But there are
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also many examples of cases of acute poisoning where a product
has been put to its intended use, such as when cadmium has been
used in soft drink machines and contaminated the beverage, or
when heavy metals have been released from crockery glazing into
acidic foods.
Long term effects may arise from low exposures either long after
the exposure has terminated or after extended periods of expo-
sure. The symptoms may be loss of vitality, psychological
disturbance, organ damage, mutation, damage to fetuses, and cancer.
One well known example is the ability of vinyl chloride to induce
liver cancer after a latency period of 15-20 years.
The problem of relating illness to the effect of some chemical
is often evasive, and even suspected relationships may be hard
to prove because there may have been other factors simultaneously
influencing the health situation of the individual in devious
ways. In some cases, the only method of value in discerning such
a relationship is by statistical epidemiological study. Although
a very useful method, it can only demonstrate after-the-fact dam-
age, and will not warn of hazard before harm is done.
Most commonly, prediction of hazards must rely on toxicological
tests carried out on some type of organism. Although substantial
gains have been made in perfecting methods, the validity of
results from other organisms as related to effects in man is
constantly debated, and much knowledge has yet to be developed.
Some substances may be retained and accumulated in certain organs,
their effects becoming manifest after certain concentrations have
been reached. This, for example may be the case of cadmium, to
which humans are exposed by way of many products like ceramic
glazes, solder, rubber, plastics, paints, textiles, etc. Also
well known examples of substances accumulating in tissues are
certain synthetic stable hydrocarbons such as PCBs.
Chronic effects may also result from long term exposure to chem-
icals which do not accumulate in the body, such as sulphur dioxide
This compound resulting from combustion of oil products is a
significant cause of respiratory ailments.
Danger of damaging contact with a chemical product is naturally
greater for individuals exposed to relatively larger doses, such
as workers, or housekeepers daily using a product. Products
used in the closed environments are very important causes of
damage to health, cheiricals purposely or inadvertently intro-
duced into food are also important.
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Chemicals dispersed in the natural environment will have effects
on man, as well as other organisms and ecosystems. The distri-
bution of chemicals in the natural environment may be regarded
in four steps: discharge, transport, deposition, and possible
uptake by organisms. Once discharge has taken place, it becomes
almost impossible to limit dispersion and subsequent damage. In
general, damage should, therefore, be prevented by limiting dis-
charges. This is being done partly by restrictions on dis-
charges to water and emissions to air from stationary sources
such as factories and power plants.
In the overall pollution situation, the diffuse, non-point sources
are charged with increasing significance. A vast number of dif-
ferent products constitute such sources such as transportation
vehicles, pesticides and fertilizers, detergents, paints, sol-
vents, etc. The only remotely practical way of limiting environ-
mental contamination from such sources is to carry out some form
of product control.
Chemical products dispersed in the environment will not only
affect man's health through contact with air, water and soil and
through food, but they will also have a variety of effects on
the environment.
These effects are in some cases even more difficult to predict
than direct effects on man, owing to variations in types and
levels of exposure, and to the large number of different organ-
isms, sometimes interdependent, that exist under a variety of
environmental conditions.
Because of the complexity of natural conditions, laboratory tests
which shed true light on environmental effects are difficult to
set up. Apart from acutely toxic substances, persistent substances
such as the halogenated hydrocarbons and heavy metals have partic-
ular environmental significance. Metals, and to some degree hydro-
carbons , may even be converted to compounds more poisonous than
the original substance by biosynthesis (as mercury may be trans-
formed into methyl mercury). Persistent substances may bioaccumu-
late in individual organisms and through the food chains, result-
ing in thousand-fold higher levels than those of the ambient
environment.
Some chemicals may have more serious effects on the environment
than on man directly, of which acid precipitation over Scandi-
navia may be an example. The acid is formed in the air by sul-
phuric pollutants emitted in large quantities in the middle
European countries and from some local sources, and is shown to
have devastating effects on fish and other limnic life over large
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areas in Norway. Ecosystems may also be disturbed by chemical
substances not particularly poisonous. Phosphates from fertil-
izers, detergents and other sources will under certain conditions
give rise to abnormal algal growth in inland waters, causing
oxygen depletions and subsequent death of fish and other organisms.
Some products having relatively insignificant direct effect on
organisms may turn out to have the most profound impact on
environmental conditions, leading to various forms of damage to
life. One such product may be fluorocarbons used in spray cans
in great quantities. As the substances find their way into
the stratospheric ozone layer they may react with the ozone,
and reduce the amount of free ozone. It is feared that this
may lead to an increase in ultraviolet radiation, resulting
in increased incidence of cancer and other ecological damage.
A chemical product may give rise to a large number of effects
associated with all stages from production to final disposal. A
full assessment of the impacts of a chemical on society and the
environment may cover any number of problems related to production,
distribution, use and disposal, and questions of direct exposure,
entry routes to the environment, environmental exposure levels,
uptake in organisms and toxicological and ecological effects.
Such comprehensive analyses have been made for a fair number of
chemicals. There is also a very large litterature on specific
effects of chemicals, particularly in animal toxicology. The
problem here is that information is not increasing in pace with
a growing number of chemical products used.
There is presently great need for more knowledge concerning the
effects of chemicals and how to limit them. It is clearly
essential to prevent damage to the individual, to populations and
the environment, instead of the present tendency to try to
correct damage once it has been done.
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3.2 U.S.A.
3.2.1 Major Legislation
There are over 20 different acts that have provisions concern-
ing chemicals inimical to man or the environment. The emphasis
here is on environmental chemicals and on products for which
there is no long-standing tradition of control. Therefore, laws
pertaining to foods, drugs, cosmetics, explosives, pesticides,
and other less related laws will only briefly be commented upon.
The Consumer Product Safety Act of 1972 , which established the
Consumer Product Safety Commission (CPSC), is a relatively strong
legal tool that provides a number of options for product control
regulation. While tobacco, motor vehicles, pesticides, aircraft,
boats, food and drugs are excluded, it covers must other con-
sumer products that represent unreasonable risks of injury.
When necessary, the Commission may formulate product safety
standards with emphasis on performance requirements. Standards
may also contain requirements pertaining to composition, con-
tents, design, construction, packaging, or labeling with warn-
ings or instructions. To insure openess and public participa-
tion, the Commission has to file public notice identifying the
product and risk involved. Each notice must also include an
invitation for any person to offer to develop the proposed
product standard.
When a product presents an unreasonable risk of injury, and no
feasible consumer safety standard will adequately protect the
public, the Commission may ban the product.
The law provides that any interested person may petition the
Commission to develop a new product safety standard or to amend
or revoke existing standards.
When the Commission decides that a product presents imminent and
unreasonable risks of death, serious illness, or severe personal
injury, the product may be seized, or the marketer may be required
to give public notice concerning risks, or to recall, repair,
replace or give refund for such a product.
The Commission may also require pre-market notification for
products which incorporate such design, material or form of
energy exchange which has not previously been used substantially
in consumer products or for which there is insufficient informa-
tion to determine safety of the product.
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The manufacturer is responsible for insuring that the product
conforms to standards, and the Commission may prescribe a testing
program when necessary.
A marketer has to notify the Commission immediately whenever
a product fails to comply with product safety standards, or
contains a defect which could create a substantial product hazard.
When necessary, the Commission may order the marketer either to
give public notice, direct individual notice, or to change,
replace, or give a refund for the product.
The Commission may specifically require records and reports on
products from marketers, and has the right to inspect the premises
and documents of manufacturers and distributors to check compli-
ance with the Act.
Imported products may be stopped by Customs if they fail t9 comply
with safety standards or lack appropriate labeling or warning.
Products that are exclusively exported are not covered by the
Act.
The Act states the right of any person to sue for damages any
person who knowingly has violated a product safety rule, and
that remedies so provided shall be in addition to other remedies
provided by other liability laws.
While the Commission has primary responsibility for enforcement,
any interested person may also bring court action to enforce a
consumer product safety rule. The Act also require CPSC to
cooperate with states and other federal agencies, and states
the right of CPSC to acquire information from other agencies.
The Federal Hazardous Substances Act of 1960 provides authority
to monitor and regulate: (1) any substance which is toxic,
corrosive, and irritant, flammable or combustible, or which
generates pressure through decomposition, heat or other means,
if such substance may cause substantial personal injury or
illness as a result of any reasonably foreseeable use; (2) any
radioactive substance determined to be hazardous and (3) any
toy or other article intended for use by children which is
determined to present an electrical, mechanical or thermal
hazard.
The Consumer Product Safety Commission (CPSC) is directed to
establish reasonable variations or additional label requirements
for those substances found to present a special hazard to public
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health and safety. The law prohibits the delivery or receipt
in interstate commerce of any banned or misbranded hazardous
substance, and authorizes CPSC to conduct inspections and
investigations in the enforcement of these regulations, and
to seize products not in conformance.
The Poison Prevention^ Packaging Act of 1970 contains authority
to regulate packaging of household substances including hazardous
substances as defined under the previously mentioned Act, pesti-
cides, food, drugs, cosmetics and fuels. CPSC may set standards
for safety packaging to protect children from serious personal
injury or illness, and may forbid packaging that is unnecessarily
attractive to children.
The Federal Insecticide, Fungicide and Rodenticide Act of 1947
as Amended by the Federal Environmental Pesticide Control Act
of 1972 provides that all pesticides products be registered with
EPA and reviewed for effectiveness and safety to man and the
environment. All pesticide products must be classified for
general use (available to the general public), or for restricted
uses (only by certified applicators). All products previously
registered under the Act of 1947 must be re-registered and
classified in accordance with the 1972 Amendment. The registra-
tion of a pesticide product may be canceled if new evidence
indicates that the product generally causes an unreasonable
adverse affect on the environment. If action is necessary to
prevent an imminent hazard during the time required for cancella-
tion, the Administrator may suspend the registration of pesticide
immediately. Hearing processes may be initiated whenever a pesti-
cide product is canceled or suspended. The establishment in
which a pesticide is produced must be registered and producers
must be registered and must maintain such records as are required
by regulation. A pesticide must be used in accordance with its
labeling.
The Occupational Safety and Health Act of 1970 authorizes the
Secretary of the Department of Labor to provide for the general
welfare by assuring, as far as possible, every working man and
woman in the nation a safe and healthful working condition. The
law authorizes mandatory occupational safety and health standards,
requirements of record keeping of employee exposure to hazardous
materials, inspections and investigations of places of employ-
ment, and in the case of a violation of any standard or rule,
citations or proposed assessments of penalty to the employer.
The Secretary may also take immediate action to restrain any
conditions or practices in any place of employment if imminent
danger exists.
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The Act also authorizes the Secretary of Health, Education
and Welfare (HEW) in consultation with the Secretary of Labor,
to conduct research relating to occupational safety and health.
In addition, the Secretary of HEW is to publish annually a
list of all known toxic substances, and to develop criteria
and recommended occupational safety and health standards for
handling these substances.
The Federal Food, Drugs, and Cosmetic Act, as amended 1972,
authorizes the Secretary of the Department of Health, Education,
and Welfare (HEW) to monitor and regulate the manufacture and
distribution of any food, drug, device or cosmetic. Considera-
tion is to be given to the safety, efficacy, and toxicity of
ingredients of drugs (human and veterinary), food and food
additives, and cosmetics. The Environmental Protection Agency
is to set levels for maximum residues of pesticide in food and
feed crops, while the Food and Drug Administration (of HEW) is
authorized to enforce the levels. In establishing pesticide
tolerances, the manufacturer must submit data on safety (toxi-
city to lab animals), the amount, frequency and time of applica-
tion, and methods for identifying and removing excessive
residues.
The Clean Air Act of 1970, as amended, directs the Administrator
of the Environmental Protection Agency (EPA) to set national
ambient air quality standards for various pollutants -- both pri-
mary standards, at a level which will protect the public health,
and more stringent secondary standards, at a level to prevent
the many other undesirable effects of pollution. The primary
standards are to be achieved within five years (subject to a
possible two-year extension) and the secondary standards are
to be achieved within a longer time which each State can set,
subject to EPA approval. Each State is required to adopt
sufficient emission standards for individual pollution sources
to achieve the ambient standards. If the measures adopted by
a State are insufficient, EPA is required to adopt additional
or more stringent measures. Cost is not a factor in achieving
the primary (health-based) standards. Emission standards need
not be limited to levels achievable by current technology, but
instead can be used to force the development of new technology
by private industry, with a "safety valve" extension procedure
available to those who can show that they made maximum efforts
to meet the standards, but failed.
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The Clean Air Act also directs EPA to establish nationwide
emission standards for various categories of industrial plants,
which new or modified sources of pollution must meet. These
"new source performance standards" must be equal to what is
achievable by the "best available" technology. They are allowed
to push the development of technology to some extent, but cost
factors must be considered.
EPA is directed to establish nationwide emission standards for
pollutants which are exceptionally hazardous to human health.
These standards are to be set at a level which provides an
"ample margin of safety" rather than a level based on cost or
available technology. The Administrator is empowered to grant
extensions of up to two years for compliance by existing sources,
but not for new sources.
For motor vehicles, the U.S. Congress itself established standards
requiring a 90% reduction in pollutants within five years, with
a one-year extension being available from EPA if the automobile
manufacturers can show both that technology is not available
and that they made maximum efforts to develop the technology.
The Act allows EPA to establish regulations pertaining to the manu-
facture or sale of fuel or fuel additives which endanger public
health or interfere with the performance of pollution control de-
vices on vehicles, and to establish emission standards for aircraft,
Citizens are given the right to bring lawsuits against pollution
sources for not meeting applicable standards and aganist EPA
for not carrying out the law.
The Federal Water Pollution Control Act Amendments of 1972
mamTatecT a comprehensive program to restore and maintain the
chemical, physical and biological integrity of the Nation's
waters. The stated goals of this Act are (1) to obtain, by 1983,
an interim level of water quality that provides for the protec-
tion of fish, shellfish and wildlife and recreation, and (2) to
achieve the elimination of the discharge of all pollutants into
the waters of the United States by 1985.
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The Act requires the individual States to adopt ambient stan-
dards protecting the uses of all waters and develop detailed
plans for maintaining the desired quality. The Act directs
EPA to set effluent limitations for most of the major indus-
tries in the country. These standards, are to be based on the
"best practicable" technology — to be achieved by 1977 — and
the "best achievable" technology by 1983.
Compliance with the water quality standards is achieved by a
nationwide system of permits. Permits must be obtained from
EPA (or from States with approved permit programs) prior to dis-
charge into waterways. Permits contain conditions limiting the
volume of waste water and the amount and type of pollutants which
may be discharged.
Other provisions of the Act direct EPA to develop limits of toxic
pollutants, pretreatment standards for industries discharging
into a municipal treatment plant, and provisions regulating spills
of oil and hazardous substances.
The Safe Drinking Water Act of 1974 requires EPA to set national
health standards for public water systems, including primary -
standards which establish limits for contaminants to safeguard
the public health, and secondary standards which apply to the
odor, taste, and appearance of the water. It directs EPA to
conduct research and studies regarding health, economic, and
technological problems of drinking water supplies, and specifi-
cally concerning viruses and contamination by cancer-causing
chemicals. The Act further provides for the protection of
underground sources of drinking water by means of a regulatory
program similar to that governing public water systems. Although
EPA has the primary responsibility for establishing the national
standards, the States are responsible for enforcement and super-
vision of public water supply systems and sources of drinking
water.
The Marine Protection, Research and Sanctuaries Act of 1972
regulates the dumping of all types of materials into ocean waters,
and allows for prevention or limitation of the dumping into ocean
waters of any material which would adversely affect human health,
welfare or amenities, or the marine environment, ecological systems
or economic potentialities. The law prohibits the dumping or ra-
diological, chemical or biological warfare agents and high-level
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radioactive wastes, and regulates, through a permit system, the
ocean disposal of other materials. The secretary of the Army
may issue permits for dumping dredge material, while EPA has
the responsibility of issuing permits for all other materials.
The law further charges the Secretary of Commerce with responsi-
bility for a comprehensive and continuing research program involv-
ing the long-range effects of pollution, overfishing or man-induced
changes in ocean ecosystems. The Secretary of Commerce is also
authorized to designate as marine sanctuaries those areas that
should be preserved or restored for their conservation, recrea-
tional, ecological, or esthetic values.
The Solid Waste Disposal Act of 1965 provides for assistance to
state and local governments, and others involved in managing
solid wastes, by financial grants to demonstrate new technology,
technical assistance through research and training, and encour-
agement of proper planning for state and local solid waste manage-
ment programs. Under the Act, collection and disposal is left
to the local governments.
The Resource Recovery Act of 1970 amended the legislation to pro-
vide a new focus on recycling and recovery of valuable waste mate-
rials. The Act directs EPA to publish guidelines for solid waste
recovery, collection, separation and disposal systems, and to
supervise the construction, demonstration and application of waste
management and resource recovery systems for the preservation of
air, water and land resources. EPA was also authorized to con-
duct a comprehensive research and development program to develop
and test methods of dealing with collection, separation, recovery,
recycling, and safe disposal of non-recoverable waste. Training
grants are to be given in occupations involving design, operation,
and maintenance of solid waste disposal systems so as to develop
the needed highly skilled engineers and technicians.
The Transportation.Safety Act of 1974 consolidates under the
Secretary of Transportation the regulatory and enforcement
authority to protect against the risks to life and property which
are inherent in the transportation of hazardous materials in all
modes of commerce. Under this law, the Secretary may issue rules
governing any safety aspect of transporting these materials, in-
cluding packaging, labeling, routing and handling. The law allows
the Secretary to establish a program of registration for people
who transport or manufacture certain designated hazardous materials
One section of the Act deals specifically with regulation of
aerial transport of radioactive materials to prohibit any
transportation of radioactive materials on any passenger-carry-
ing aircraft unless the radioactive materials are intended for
use in research, medical diagnosis or treatment and the mater-
ials as prepared do not pose an unreasonable hazard to health
and safety during transportation.
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3.2.2 Proposed Legislation
Legislation has been proposed in two areas important to environ-
mental product control. One concerns toxic substances, the other
hazardous waste.
Toxic substances is a term covering industrial chemicals which
are not covered by existing legislation. The first bill on
toxic substances control was introduced in 1971, and since then,
several versions have been considered. As of May 1976, Congress
is working on new bills, and passage could be anticipated this
year, or next.
Bills on toxic substances control presently under consideration,
propose that EPA be granted the authority to require information
on i.a. chemical identity, proposed uses, estimates of amounts,
description of by-products, and number of workers exposed to
both new and existing chemicals, to require tests to be performed
by producer or marketer on health and environmental effects, and
to regulate those substances which present or are likely to pre-
sent an unreasonable risk. Specifically, EPA could establish
test protocols for such chemical substances where there may be
substantial exposure, or if there is insufficient data to con-
clude that a risk does or does not exist, and where testing
would assist in making such a determination.
EPA would also institute a system for the premarket screening of
new chemical substances. Manufacturers and processors of new
chemicals, or existing chemicals for significant new uses must
give information as mentioned above, including test data, 90 days
prior to marketing. If the chemical is on an EPA list of chemi-
cals which may contribute to unreasonable risks, the marketer
must provide test data which show that there is no such risks.
EPA may prohibit or limit manufacture if data are insufficient
basis for risk assessment.
EPA will also have authority to prohibit or limit manufacturing,
processing, or distribution of a chemical, or require labeling,
and EPA can take prompt action in the event of an imminent
hazard.
If risk presented by a chemical may be sufficiently reduced by a
federal law administered by another agency, EPA shall request
that agency to determine the risk. If that agency finds no risk,
or conversely, takes action, EPA may not take regulatory action.
The aim of the act is to provide adequate testing by manufacturers
or processors with respect to effects on health and the environ-
ment. It provides comprehensive authority to regulate any chemical
substance at any stage from production to final disposal.
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In order to reduce hazards connected with waste, it will be
possible to regulate composition or contamination of products
and probably also by-products from the production process. The
Act will also give authority to regulate the disposal of waste
both from manufacturer, handler or user. Authority concerning
wastes in this Act overlaps to some extent with provisions under
the Solid Waste Utilization Bill described in section 5.2.2.
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3.2 U.S.A.
3.2.3 The Product Control Situation
The U.S. has a very large chemical industry, both in absolute
terms and per capita. The industry's production volume has
almost doubled over the past decade, with synthetic organics,
paints, dyes, inks, plastics and elastomers expanding most
rapidly.
The chemical manufacturers maintain that present voluntary pre-
market testing and assessment generally is adequate for protec-
tion. Yet the industry vehemently opposes new legislation on
grounds that testing requirements will unduly raise costs. This
apparent contradiction seems to indicate that present testing
activity is held back to cut costs. The Environmental Protection
Agency (EPA) has estimated that testing requirements under the
proposed Toxic Substances Control Act would cost industry from
$80 to $140 million (sales are estimated at about $72 billion,
profits at more than $5.5 billion, and research and development
costs about $2 billion in 1974).
In the present situation, the government cannot require testing
or disclosure of industry information needed to assess effects,
and has no authority to control production, distribution or use
or disposal of "toxic substances" not addressed by specific laws
(as pesticides, drugs, food, etc.). Meanwhile, a great number
of synthetic chemicals turn up in air, drinking water, meat, fish
and plant based foods.
According to the EPA Administrator there is now a need to move
from limited curative action to preventive action. This can
only take place on the basis of new toxic substances legisla-
tion. EPA is preparing for regulatory action in anticipation
of new legislation.
Control of chemical products in the workplace is the responsi-
bility of the Occupational Safe,ty and Health Administration (OSHA)
It is probably not unfair to say that occupational health protec-
tion in the U.S. is presently insufficient, and that substantial
improvement is necessary. The recent Kepone (pesticide) incident
in Hopewell, Virginia, illustrates the inadequacy of enforcement
(and lack of employer responsibility). In the plant, where
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conditions later have been described as "incredible", a large
portion of the work force were on sick leave or had to find
other employment, many with permanent damage. While average
conditions certainly are not that bad, the Council on Environ-
mental Quality (CEQ) sees improvement of occupational health
protection as a very important issue.
At present, only a few occupational health standards have been
promulgated, and enforcement has been difficult because of
lack of resources. Although Congress has enacted a relatively
strong piece of legislation, many people are of the opinion that
institutions charged with administering the law are inadequately
equipped. The occupational health sector appears to have been
particularly sensitive to industry's warnings of adverse eco-
nomic and employment effects, and there has been heavy pressure
to limit agency operations.
New health standards, as other environmental standards, are
often contested in court (as for example the vinyl chloride
standard, which was unanimously upheld in 1975). OSHA is under-
taking a massive effort to produce health standards which address
specific substances. Within the next few years, several hundred
standards may be completed. Subsequently, compliance enforce-
ment must be significantly boosted.
For the protection of farm workers, minimum reentry times from
24 to 48 hours have been established for some highly toxic
pesticides as a national minimum requirement. Some States,
notably California, have much stricter requirements. However,
it is believed that many incidents of poisoning go unreported,
and enforcement and reporting may have to be further intensified.
More and more studies indicate that the indoor environment,
where perhaps most people spend most of their total time, is
an environment where significant exposure to chemical agents
takes place. So far, little work has been done to assess the
total and combined impact of such things as toxic gases from
gas ranges and oil heaters, indoor pesticides and disinfectants,
detergents, paints, solvents, aerosol sprays, plastics leaking
hydrocarbons and other synthetic material into air and food,
new glues, and other products. EPA is taking some interest
in studies of air quality, the Consumer Safety Protection
Commission (CPSC) looks at products with mostly short term
effects, and FDA has responsibility for example for food wrap-
pings (as well as foods, drugs and cosmetics). An intensified
and more comprehensive approach will probably develop over some
years, as more studies throw light on the situation.
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The consumer, using a variety of chemical products in household
and leisure situations, is exposed to both acute and long-term
hazards. Actions by CPSC are primarily aimed at acute hazards
by requirements of labeling and safe packaging, little emphasis
has been placed on long term hazards. Certain products have
been regulated as to content (such as lead in paint), and a
few have been banned (such as vinyl chloride in spray cans).
Apart from labeling and packaging regulations, sale of products
with chemical effects is rather unrestricted. While it is may-
be too early to judge the impact of the agency's work, signifi-
cant progress has been made to reduce child poisoning from drugs.
Control of chemical contamination of food is under the Food and
Drug Administration (FDA), and the prolonged legal battles fought
against food additives illustrate the technical and legal diffi-
culties involved in its efforts to protect the public. While a
lot of good work obviously is done by FDA, many share the feeling
that FDA's position is too weak in the control of food additives.
Work in the field of cosmetics has not been substantial.
The management of pesticides is well established. All products
must be registered with EPA, which assesses test results sub-
mitted by the applicant. Pesticides are classified into two
classes, one for restricted and one for general use. Establish-
ments producing pesticides are being registered. Products are
not yet subject to packaging regulations, but work on child
safety packaging is being started. A factor which greatly in-
creases administrative work, and which makes treatment of acute
poisoning cases more difficult, is the fact that the U.S. has
a very large number of registered products, in all some 40,000.
While critics hold that EPA was largely rubber-stamping these
chemicals up to about 1975, more decisive action has subsequently
taken place as manifested by the banning of DDT, aldrin and
dieldrin, and suspension of heptachlor/chlordane.
Hazardous wastes resulting from products or from activities re-
lated to products is a problem not satisfactorily addressed.
Adequate technology for waste disposal exists for most substances,
but there is no legislation to control and enforce adequate
practices. CEQ has repeatedly underlined needs for regulation
in this area, as contamination from wastes increases.
In many urban areas, emissions from motor vehicles present seri-
ous health hazards. As a result of restrictions, substantial
reductions in emissions per vehicle mile traveled have been
achieved, but because of the increasing number of automobiles,
total nationwide emissions have increased by about 3.4% per
year between 1960 and 1970. With the present goals for reduc-
tion of emissions, it is believed that there will be substantial
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air quality improvement concerning hydrocarbons and carbon
monoxide, but that there will be an actual increase in
nitrogen oxide because of anticipated strong increase in such
emissions from stationary sources. The ambitious motor vehicle
control program is under heavy pressure from industry, and has
been deferred on two occasions. Problems with unintended
pollution by platinum and sulphuric acid mist (from the catalytic
converter) also hamper the program.
No regulations pertain to sulphur content in oil or coal products
to reduce pollution by sulphur oxides.
Additives to motor vehicle fuels may have significant effects
on public health, as well as on emission control systems, and
are required to be registered with EPA. Proposed limitations
on the content of lead in gasoline have narrowly been upheld
in the courts,the goals to be achieved by 1979.
Products to be used to disperse oil spills on water must be
registered with EPA. No such products intended for marketing
have been registered yet.
In the 1974 National Water Quality Inventory Report to Congress
made by EPA in 1974, nitrate and phosphate levels in water
contributed to byproducts such as detergents and fertilizers
were significant. These pollutants increased by 54% and 74%,
respectively, in 1968-72 over the previous years. There are
no regulations pertaining to these products.
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3.2.4 The United States Environmental Protection Agency (EPA)
EPA began operations in December 1970 to protect the health and
welfare of the American people by controlling pollution hazards.
In pursuit of this the Agency sets and enforces air and water
pollution standards, monitors pollution, controls pesticides,
set standards for noise and general ambient standards for radia-
tion, works on solid waste management, conducts research and
demonstration projects and supports state and local environmental
efforts. The Agency has an extensive field organization with
regional offices in ten major cities, and national environmental
research centers in four locations, as well as a number of
smaller laboratories throughout the country.
Toxic Substances
Almost every EPA office with program, research or legal respons-
ibilities is involved in some way with efforts to control toxic
substances. Such activities in the offices are integrated into
the office programs, and the strategy of the Office of Toxic
Substances (OTS) can be considered as a core strategy of the
Agency's overall efforts to control toxic substances.
While OTS has no part of EPA authority to administer directly,
it carries out important support functions for other EPA programs.
Since toxic substances control actions by EPA seem to be impend-
ing (see section 3.2.2 on proposed legislation), and because it
will develop into a program of great importance, a presentation
of some of the main aspects of a possible control strategy will
be made here. The degree to which the following principles
will be carried out obviously depends upon powers vested in
the law, and must be regarded as indicatiye on1y.
An approach to the control of environmentally significant chemi-
cals will be directed primarily to those substances which exhib-
it adverse effects at relatively low concentrations, and con-
cerns toxic effects resulting from sustained chemical or biolog-
ical activity. Other hazardous effects such as fire, explosions,
and radioactivity will not be in the primary plane of focus. EPA's
concern with toxic substances is two-fold. The basic issue is
to identify and assess the risks associated with the manufacture,
distribution, use and disposal of chemicals and weigh these
against the benefits. The other is to take practical steps to
mititgate or prevent unwarranted risks posed by chemicals, by
voluntary or mandatory actions as appropriate.
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The toxic substances control activity may be structured on
three main functions:
-Coordination and support of agency-wide efforts, with
particular attention to pollutants deriving from multiple
sources or which are significant in several of the
environmental media, and corrdinate EPA activities with
other agencies.
-Line function, such as assessment of risks and control
options for products, development of regulations, monitor-
ing strategies, and research needs assessment.
-Crisis function, including mobilization of agency
resources to clarify a problem, and develop an imple-
ment control measures.
A list of program elements can be based on these functions:
-Restrictions
-Testing
-Industrial Reporting
-Early Warning
-Monitoring
-Crisis Response
-Research Needs
-Strategy and Coordination
These elements will be elaborated upon in the following.
Restrictions
A major problem is to select the substances of greatest concern
and subsequently assess the risks and benefits associated with
them. Given the diversity of effects, production and use
patterns, economic, trade and labor issues, a good assessment
is formidable task. Given the size of sector of industry
involved in commercial chemicals not currently subject to regu-
latory authorities, it seems totally unrealistic to expect di-
rect governmental intervention to regulate a large fraction
of these products, each of which is to some extent a unique
case. Much effort will, therefore, probably be directed at
heightening industrial concern over the necessity to clarify
the risks and to take action to reduce the risks, in other
words make industry regulate itself as far as possible. To
this end, EPA could give explicit public recognition of posi-
tive action taken by industry, and could take general regula-
tory action to force a re-orientation of industrial decision
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making processes. Efforts will also be directed towards encour-
aging trade associations and professional societies towards
greater responsibility.
Wherever necessary, direct restrictions will be imposed to miti-
gate severe environmental problems or to prevent future problems.
The need for restrictions, what form they should take, and the
impact of such restrictions must be clarified by defining govern-
mental decision making criteria. In general terms these criteria
are health effects, environmental effects, economic considera-
tions, alternative materials, etc.
The basis for regulatory action is a thorough assessment to
determine the appropriateness of regulatory actions. Such
analysis will include factors such as risks, benefit costs,
market trends, available and projected control technologies,
extent and effectiveness of current regulations, and a study
of available regulatory options.
Testing
Although the testing programs of some of the larger companies
are acknowledged, current testing activities are generally in-
adequate, as reflected by the lack of effects data, the periodic
occurrence of adverse environmental incidents and a conspicuous
absence of information for identifying potentially harmful
substances. Capabilities to interpret data are also limited.
Industry tends on the whole not to release much of its test data,
a practice that limits government's capability to participate in
assessment of chemicals. A great total testing effort is under-
taken by government laboratories and universities, but testing
is predominantly science oriented and thus not always directly
applicable in regulatory situations. Finally, the state of the
art of testing needs to improve to meet present needs.
To tackle the problems of testing, EPA sees a need to improve
approaches by government, industry, and the scientific commu-
nity. EPA hopes to draw on industrial experience in develop-
ing testing procedures. The two key tasks are the determination
of the chemicals which are to be tested, and the actual test
requirements. To select those chemicals, methodologies for
ranking priorities must be developed, based on multiple criteria
such as similarity to known problem substances, production levels,
inadequacy of available test data, presence of the chemical in
the environment etc. Formulation of test requirements for all
types of chemical products is beyond reach, and the agency will
seek to provide guidelines concerning the types of test data
needed. However, for some selected chemicals test protocols
will be made up in detail.
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Industrial Reporting and Processing of Data
Adequate control of chemical products requires not only effects
data, but industry information on levels of production, use,
geographical distribution of such activities, by-products, etc.
Information is these areas available from government sources
are inadequate, and EPA must set up a system whereby industry
gives annual reports and pre-market notifications. Given the
number of substances produced and the number of producers, it
is essential to limit reporting requirements to data that will
be directly usable for pre-market screening, regulatory or early
warning purposes.
For existing chemicals, EPA will have to set priorities based
largely on best judgement to require reporting on predetermined
classes of particularly troublesome chemicals.
For new chemical products, and for new uses of existing products,
data will be required from industry to determine potential adverse
effects prior to marketing. Systematic files of such information
will constitute a most important tool in efforts to prevent ad-
verse effects. The data system must be able to point out chemi-
cals that belong to chemical classes that have caused past prob-
lems, or processes with certain properties that should trigger
further investigation. It is also important that the system
point out products that are produced in large quantities and
are used in a way which results in large human or environmental
exposure. The system must be designed to perform a rapid screen-
ing process which should help pinpoint chemicals of concern.
Early Warning
Essential to warnings of incipient crisis is a viable data
system as mentioned above. Review of all data on all chemicals
or even limited data on all chemicals, is not practical. Crite-
ria must, therefore, be developed for how to select chemicals
that show potential for causing adverse effects. These criteria
could be based on relationships between properties of a substance
and its possible environmental effect. Past cases will be studied,
and formal ranking schemes or mathematical models will be developed.
Early warning capability will also be enhanced by establishing
a panel of experts knowledgeable in various areas of industrial
processes, environmental problems, and chemically induced health
effects. Another important reinforcement of early warning activ-
ities will be the search for indicators in information from moni-
toring, trend assessment, industrial reporting and the open
literature.
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Monitoring
Monitoring of the environment is of prime importance for assess-
ment of the risk posed by substances in the environment and by
new substances entering the environment. Monitoring data are
required to determine the need for regulatory action/ and to
review the effects of regulatory actions. At present, monitor-
ing programs for water and air are directed towards major, well
known pollutants and pesticides. There is a need to single out
useful information from existing monitoring systems and initiate
new monitoring efforts. Monitoring is costly and complicated,
both regarding methods and interpretation of data, and comprehen-
sive monitoring for a large number of substances in all media is
impractical. Target substances for monitoring must be carefully
selected in limited geographical areas, and monitoring strategies
should be tailored to each substance. Since such activity will be
substance-specific, EPA must devise monitoring methods to discover
previously unsuspected chemicals in the environment. EPA will
attempt to use field information from its regional offices and
teams of monitoring and assessment specialist who can respond
to alarm signals. Further, attempts at a system of biota
indicators will be made, and some scheme of selecting geograph-
ical areas.
Crisis Response
The increasing frequency of incidents of environmental contamina-
tion from toxic substances makes an effective crisis response
capability necessary. It is felt that regional offices with
their considerable experience in dealing with air pollution
alerts, spills of oil and hazardous materials in waterways,
and misuse accidents with pesticides, will be capable of the
most direct response. EPA headquarters will aid local efforts
by making available a range of specialists who can analyze tech-
nical aspects of the problem, by facilitating rapid access to
relevant reports and scientific data, by keeping abreast of
monitoring and data analysis capability to determine the distri-
bution and levels of the product substance, and by preparing
coordinated action with other federal agencies.
If a crisis incident points to the need for actions to reduce
the probability of similar incidents, EPA will write guidelines
for identifying and sampling potential hot spots around the
country, make available adequate laboratory capability to
analyze monitoring samples and review the need for research
to clarify the properties of the substance. Where the situa-
tion may call for regulatory action, EPA will maintain a
readiness to develop and implement regulatory steps.
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Research
There is a need for research in new areas as well as to orient
the current research efforts more specifically to actual pro-
gram requirements. Improved test methods that are more re-
sponsive to regulatory needs are urgently needed, as are tech-
niques for estimating human and env; ror-niental exposure levels
and techniques for assessing economic, technological and market
trends which may give forewarnings of future problems with
chemicals. Further work will be done 10 develop rapid and low
cost testing methods for predicting chronic effects in screen-
ing procedures, and methods for predj c t jjjq environmental effects
are needed.
Enforcement
Enforcement of regulations pertaining f.o production, import,
use and waste disposal may become an activity of considerable
magnitude. Enforcement will probably V;: carried out primarily
by the EPA regional offices, supported by a team of technical
experts at headquarters.
EPA's Office of Toxic Substances is currently working actively
with some of these program elements and j s preparing method-
ologies in those areas which depend on new legislative authority,
Substantial efforts are made in monitoring, test methods, early
warning techniques, and both preliminary and in-depth studies
of specific chemicals, groups of chemicals and industry cate-
gories. A major portion of the work is done by contracts. The
number of professionals in OTS is presently around 40, antici-
pated to increase to about 90 if legislation is enacted. The
budget is expected to increase correspondingly from around
$7 million to $20 million/yr. Activities in control of chemical
products require very large resources. At the future funding
level as indicated, some 15 chemicals (or groups of chemicals)
may be under study at any time, and about 2-4 regulations promul-
gated per year.
Pesticides
There are four major parts to the U.G pesticides program:
supply control, use control, hazard evaluation and research
and special studies. The major thrust of supply control is the
classification of pesti^des for either general or restricted
use. Registration is required to insu:c that products are
reasonably safe and effective, and to a A low EPA to restrict the
use of products which may cause unreosonoble adverse effects,
including injury to the applicator. The Act does not allow
limitation of the number of pesticides in use. The present
number of registered products is very high, around 40,000,
based on around 1,000 chemical compounds..
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50
About 55% of pesticides are used by agriculture, 30% by indus-
trial, institutional and government users, and 15% by home and
garden users. About 100-200 human deaths are reported from
misuse of pesticides each year, and there is a much larger num-
ber of cases of poisoning. Pesticides are not yet subject to
special packaging regulations, but EPA will formulate such regula-
tions for child safety packaging. All packages are presently
labeled with instructions for use and appropriate warnings. The
main thrust in the use control sector are (a) certification of
a great number of applicators of restricted use pesticides, (b)
better packaging and labeling, (c) more extensive and timely
enforcement, (d) extensive applicator training, and (3) dissemina-
tion of information to the consumer and public. Applicator train-
ing is carried out by the states under federal supervision.
In the hazard evaluation sector, extensive testing and a monitor-
ing and surveying program have been in operation for a number of
years. These efforts are made to identify possible problems and
to provide supporting data for decisions to remove registered
products which cause unreasonable adverse effects from the
market. The monitoring system supplies information on levels
and distribution of pesticides residues in the environment,
and on acute and long term exposure levels. EPA sets pesticide
residue tolerances for food and feed, and the standards are en-
forced by the Food and Drug Administration. Some major uses
of important pesticides have now been discontinued and it is
estimated that levels of dietary intake will decline fairly
rapidly.
A substantial research and development program is aimed at pro-
viding scientific data on the health and ecological effects of
pesticides, and methodologies for monitoring, analysis, and
quality control to determine pesticide residue. Possible chem-
ical and biological replacements for particularly hazardous
pesticides are being studied. The budget figures for the entire
pesticides program for 1976 is $44 million dollars, and the
program has around 1,000 permanent positions.
Product Control under the Air Program
Motor Vehicle Emission Control
Mobile sources of air pollution are significant contributors
to urban air pollution. In American cities, almost all of the
carbon monoxide, more than half of the hydrocarbons and slightly
less half of the nitrogen oxide come from mobile sources. In
order to achieve the national ambient air quality standards
for these major pollutants, Congress decided that emissions
from mobile sources should be controlled by the incorporation
of solutions into new motor vehicles at the point of manufacture,
this being the most effective point for such action. The manu-
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facturers were charged with the responsibility for developing
the technologies needed. The Clean Air Act places the burden
of producing vehicles that meet emission performance specifi-
cations on the manufacturer, and provides enforcement authority.
Congress in effect established numerical emission standards,
and did not define any solutions. While this gave little guid-
ance to manufacturers, it allowed for flexibility and industrial
innovation. It was probably also a wise decision, as the govern-
ment, which obviously cannot match the expertise of the auto
makers, might otherwise become responsible for a possibly inade-
quate solution. The solution chosen by manufacturers has been
one of add-on technology (an emission control device incorporated
in the system without changing basic principles), which may yet
prove to be less than satisfactory.
Pollution controls mandated in the 1970 Clean Air Act were to
be in effect in the 1975 model year, but have been deferred.
After the point where the original reducation goals requirements
are applied to all new vehicles (about 1982), it will take approx-
imately ten years before almost all vehicles conform, due to a
ten year turnover rate.
Successful improvement of air quality cannot be achieved if
pollution control systems in new cars were to lose their efficacy
over a short time. Vehicle emission control is one rare case
where it has been necessary to require a certain durability in
a product. EPA requires 50,000 miles of driving distance as a
lower limit for emission control equipment efficacy.
This has given rise to interesting legal and practical questions.
Manufacturers argue that their responsibility is to make emission
control devices that satisfy requirements at the time of sale.
At that moment the product moves out of their control, and it
would therefore be unreasonable to demand their continued re-
sponsibility. Nevertheless, requirements have been based on
what must be expected performance over time when the vehicle
is operated by an average prudent user who observes proper care
and maintenance needs. Periodic testing and maintenance will
be required to ensure satisfactory operation. However, such
testing authority rests with the states. So far very little
state actions have been taken, and failure to institute state
programs may seriously reduce the overall effects of the federal
emission control efforts. If a vehicle which has been properly
operated and maintained fails emission tests, the manufacturer
must cover the costs of necessary repair. The user is subject
to anti-tampering rules which make it illegal to make changes
in the vehicle that result in reduced pollution control efficacy.
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The Act allows EPA to require the recall and repair (at no cost
to vehicle owners) of entire classes or catagories of vehicles
which do not satisfy emission regulations. This is in effect a
rather strong tool to ensure product compliance. So far, more
than 1.5 million vehicles have been recalled for alterations
in the emission control system. (Recall of vehicles has been
practiced for many years for vehicles which have not had satis-
factory safety characteristics).
The program also highlights such product control issues as
compliance and enforcement of regulations. In this complicated
field, it was recognized that enforcement activities could over-
load agency capacity, and regulations have consequently been
made self-enforcing to a large measure. The manufacturer must
demonstrate that the design of his vehicles will meet emission
tests and must keep records, subject to EPA inspection. EPA
formulates testing procedures, supervises testing, reviews and
certifies applications on new designs, and performs a number
of production and vehicle in-use spot checks.
Although it is very difficult to relate reductions in auto
emissions to improvement in ambient air quality, analyses have
shown that the vehicle emission reduction goals probably will
not give acceptable air quality in some of the major cities.
Where product performance requirements are by themselves not
enough, it may become necessary to regulate product use. Congress
has indeed made allowance for in-use controls in the law --
however, it has not set any specific guidelines. According to
this authority, EPA has endeavored to impose other cures in
some cities, such as parking restrictions, vehicle free zones
and improvement of public transportation. This has been inter-
preted as federal intervention in local affairs, and has result-
ed in a very heated squabble. Most such measures proposed by
EPA have been either obstructed by Congress or turned down by
the courts. However, EPA still has certain options which may
be developed, and the States have authority to impose regula-
tions to control the use of vehicles.
It is a common trait in most recent environmental legislation
that studies of technological feasibility and cost are required.
In this case, as Congress itself set the standards, this require-
ment was not included. However, Congress will at intervals
review EPA's decisions and the need for, and achievability of,
proposed standards.
Two side effects of the vehicles emission control program are
interesting to note. One that is environmentally beneficial,
is that the chosen method involving catalytic converters re-
quires unleaded gasoline. Since gasoline is the major source
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53
of lead in the environment, this pollution will also be cut
back as emission controls increase. A negative side effect,
which led EPA to a one year suspension of standards applicable
to the 1977 model year, is a previously unrecognized problem
of sulfuric acid emissions from catalyst equipped vehicles. The
effect of this pollutant and means of control are presently being
studied. (One way to do it is to remove sulfur from gasoline
at a cost of approximately six dollars per ton of gasoline).
Imported vehicles constitute a substantial portion of the
United States market. The same requirements apply to imports.
EPA also plans emission regulations on motorcycles, light duty
and heavy duty trucks. Certain emission standards have been
set for aircraft, and significant emission reductions are
expected in 1979 and 1981.
The large and complex emission control program exhibits many of
the concepts and issues discussed in chapter 2. It also illus-
trates technical, political and economic problems, and inertia
to change in a well-established technology. It is an example
of a case where an environmentally significant product has been
based on an environmentally unacceptable principle (the internal
combustion engine). While it is doubtful that another principle
could have been chosen at the beginning in this case, the experi-
ences point out that it is also important to reassess environ-
mental impacts of products and bring about technology changes
before problems get out of hand.
The federal auto emission control program currently requires
$2 million and 53 positions for standards and guidelines
$6.1 million and 162 positions for certification and testing.
Fuel and Fuel Additives
To provide availability of lead-free gasoline for catalyst-
equipped vehicles, regulations were formulated in 1973. Also,
for the general purpose of reducing airborne lead in the environ-
ment (of which lead in gasoline accounts for 90%) a schedule for
general reduction of lead in gasoline to about 0.12g per liter has
been set. This average limit is to be attained by 1979.
For reasons of possible effects on public health, and reduced
efficacy of catalytic converters, regulations for the registra-
tion of fuel and other fuel additives have been proposed by EPA.
Fuels and additives must be registered before marketing. This
is one of few cases where a group of products has been singled
out for control for environmental protection reasons.
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Product Control Under the water Program
Water Supply
An 80 city survey of water supplies in 1974 confirmed wide-
spread low level contamination of water supplies by toxic
substances. Interim drinking water standards were proposed
in 1975, and will be supplemented and finalized on the basis
of more research and monitoring data. The drinking water
program will not be described here, since drinking water as
such is perhaps not a typical "product." It is, however,
interesting to make note of a rather unusual enforcement tool
favored by EPA. It is based on a self enforcement mechanism,
requiring suppliers of drinking water to notify consumers of
contaminants in the water. If the water fails to meet health
standards, the supplier may be obligated to notify of such
failure and of the possible resulting health effects. Such
notification, coupled with the possibility of a citizens'
suit, is believed to provide a strong incentive to maintain
compliance with the standards.
Water Quality
One group of products is directly addressed under the national
oil and hazardous substances pollution contingency plan. For
this group of chemical dispersing agents to be used on oil
spills on water, rules call for submission of data on physical,
chemical and toxicity characteristics prior to their use. In
the year since this rule was made effective, no such data have
been submitted. This means that there are presently no chemical
dispersants authorized for general use. (Other agents may be
used where necessary to prevent hazard to human life or limb
or to substantially reduce explosion or fire hazard.)
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3.2.5 The Occupational Safety and Health Administration (OSHA)
The decisive step in protective regulation of chemicals in the
occupational environment was taken with the passage of the
Occupational Safety and Health Act in 1970. Up to the present,
the greatest part of workplace improvement efforts have been di-
rected to safety, but strong action is now taken to improve control
of health-threatening chemicals. A substantial program of re-
search, rulemaking, education and enforcement training has been
started, although many hold the opinion that capacity is still
inadequate to catch up with developing problems.
Identification of hazard substances, assessment of their poten-
tial health effects, and study of control options is largely
done by the National Institute of Occupational Health (NIOSH).
The Institute also contributes to development of standards, the
promulgation of which is the responsibility of OSHA.
The lack of standards is presently seen as the main problem. Where
standards are not established, the employer has only a general
duty to maintain a safe workplace. This in effect gives inade-
quate protection to the worker (courts have construed this respon-
sibility to go only as far as to those hazards which may be rec-
ognized as clearly evident to the senses, i.e. smell, eye irrita-
tion, etc.), and the employer is not required to monitor, rep'11''
conditions, or inform workers of established threshold values.
(Recommended Threshold Limit Values exist for a number of che".>
So far, about ten standards have been promulgated for chemical,--,
and a major effort is underway to complete standards for arounJ
400 substances. Certain monitoring and reporting requirements
will be included. Fourteen standards have been established fo>
carcinogenic chemicals. The standards are largely directed \ •-•
proper practices to be followed in a plant. No permits or
monitoring is required. As part of its standards promulgation
activity, OSHA must consider economic and inflationary impacts
of proposed actions.
As standards are completed, an increase in plant inspections
for exposure to chemicals must follow. OSHA plans to step up
this activity substantially. An often-heard criticism of cur-
rent regulations is that they are not sufficiently self-regula-
ting, but require too much inspection effort. Education and
consultation programs for employers and employees in states with-
out approved health programs are considered very important. Such
programs will i.a. provide local guidance to employers, especially
smaller employers.
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OSHA's current appropriations for standards development are
about $5.2 million (about 140 positions), about $96.5 million
(about 1.700 positions) for enforcement equally divided between
state and federal activity (10% of this may be ascribed to
chemical-related inspections), and additional funds for
training, information and health statistics.
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3.2.6 Consumer Product Safety Commission
The Consumer Product Safety Act established the Consumer Product
Safety Commission, which was activated in 1973. Its primary
mission is to protect the public against unreasonable risks of
injury associated with consumer products. According to this,
the Commission will assist consumers in evaluating the compara-
tive safety of consumer products, develop uniform safety stand-
ards for products, and promote research and investigation into
the causes and prevention of product related hazards. The
Agency's authorities relating to chemicals are vested in the
Consumer Product Safety Act, the Hazardous Substances Act and
the Poison Prevention Packaging Act. These authorities are
both unique and powerful. In recognition of the complexity
of the assessments and trade-offs involved in its decisions,
the Agency has adopted a cooperative, open approach. Maximum
participation from interested groups is sought, as reflected
in a broad representation in three Advisory Committees. Also,
the Agency maintains an active information program and strives
to open its internal and external actions to interested parties.
The Agency's operation involves many of the principles and mech-
anisms of product control that are discussed in chapter 2, and
closer look will provide some interesting practical examples.
The following sketch shows a simple program structure which
identifies the major action components:
INQUIRIES
REQUESTS
AND
COMPLAINTS
CPSC HAZARD
IDENTIFICATION
HAZARD
STRATEGY
ANALYSIS
INFORMATION
AND
EDUCATION
ENCOURAGE
VOLUNTARY
ACTION
VOLUNTARY
STANDARDS
REGULATORY
DEVELOPMENT
COMPLIANCE
AND
ENFORCEMENT
SUBSTANTIAL
HAZARD
NOTIFICATION
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It is clear that the system is set up to act in a reactive
way, in that action is initiated only on the basis of after-
the-fact information on injury and death. While this may seem
to be a some what static policy more aimed at cure than preven-
tion, it nevertheless seems to be a practical way to start.
With regard to chemicals, the approach has lead to an emphasis
on acute hazards rather than long term effects.
To meet its statutory responsibilities, the Agency must collect
information on injuries associated with consumer products. This
information constitutes the major input to the planning process
and gives a rational basis for the development of appropriate
strategies for hazards and injury reduction. It has been found
that about 1/3 of accidents related to products are treated by
private physicians, and about 1/3 by hospital emergency rooms.
The information systems gathers data from emergency rooms of
119 hospitals daily. This large body of information is related
to 990 different product codes, and a ranking system is applied
to help the Agency focus on those products against which action
should be taken to reduce hazards. While chemical products are
not at the top of the ranking list, the system tells of about
100,000 estimated injuries related to such products in homes
per year. Data are also gathered from other sources such as
the National Center for Health Statistics and the National
Household Interview Survey, and the Agency is planning to expand
its data base through a physician's office survey. The gathered
information is also used as input in predictive models. For
example, one such model predicted that 20% of poisoning injuries
from antifreeze could be prevented by a poison prevention pack-
aging regulation.
Child resistant packaging has been required for a number of
drugs, resulting in a substantial drop in accident rates. How-
ever, the Agency assumes that safety packaging can only reduce
risk by about 20%, and that risk will be somewhat further reduced
by labeling and other means of information. Apart from packaging
and labeling regulations, the sale of hazardous chemical consumer
products is relatively unrestricted. The Agency has applied
stricter measures in some cases, for example by limiting the
amount of lead in paint, or banning vinyl chloride as aerosol
propellant because of possible carcinogenic effects.
For selecting appropriate regulatory measures, the Agency
develops a predictive impact analysis in which effects of
various restrictive actions are analysed. The Agency is also
examining the feasibility of regulating product hazards by
issuing generic standards as an alternative to the product
by product approach.
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The Agency's regulatory activity is partly conducted in re-
sponse to the Agency's gathered information, and partly on
the basis of petitions received from organizations or individ-
uals. Such petitions, while allowing a necessary and valuable
opportunity for providing public participation, seem to divert
a substantial part of the Agency's resources from a systematic
approach to a case by case approach.
One interesting feature of the Consumer Product Safety Act is
the institution of the "offerer" process. It is intended to
promote development of safety standards by making the maximum
use of the expertise of consumers and industry by providing
opportunities for all interested parties to participate in
the standards development process. (Most of such work is
otherwise usually done by the agencies or bv contracts with
specialized firms or institutions.) The approach has apparently
been quite successful.
The Commission believes that the development of creditable
voluntary standards in an open forum is in the public interest
and can result in more effective utilization of commission
resources, and there is considerable activity in this field.
Most voluntary standards being developed will apply to non-
chemical products.
Education of the consumer is considered to be a very important
factor in reducing hazards from product. About 1/6 of the
Agency's budget is spent on information programs through radio
and television and in schools.
The Agency's field force makes numerous inspections of various
hazardous household substances, and a large number of products
are being analyzed every year for chemical composition by pri-
vate laboratories. The Agency has also instituted "consumer
deputy" programs, in which trained volunteers have taken part
in retail surveillance for child resistant packaging and label-
ing requirements for a number of chemical household products.
An interesting self-regulatory feature of the Agency's com-
pliance program is the "substantial hazard notification."
The law expressly places responsibility on the manufacturer,
importer, distributor or retailer for immediately notifying
the Agency of any hazard related to a product which does not
comply with regulations or which poses an unreasonable hazard.
One hundred twenty-four such notifications were received from
manufacturers in 1975. The Agency also advises producers that
their products may involve defects that constitute substantial
hazards if the Agency has received such indication by its own
investigation or from consumers. There have been numerous ex-
amples of crimminal prosecutions and seizures of chemical products
The Agency's budget is about 37 million dollars, and the number
of full time positions is about 900.
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3.3 NORWAY
3.3.1 Major Legislation
The Drugs and Poisons Act of 1964 requires applications for
pre-market approval of any drug. The law also regulates
pricing and advertising of drugs. For other poisons and hazard-
ous chemicals, certain regulations apply. For poisons (as de-
fined by official listing), permits are required for production,
sale, import and export, and purchase of poisons is restricted.
There are also provisions for packaging and labeling. Other
less hazardous materials are subject to milder restrictions such
as labeling and minimum age of the purchaser. There are regula-
tions concerning responsibility in connection with handling and
storage. The law is used for reducing health hazards, and has
no provisions for controlling environmental effects.
The Pesticides Act of 1963 requires permits prior to marketing.
The marketer must provide information sufficient to show that
the benefits of the products outweigh its risks. Workplaces
which handle pesticides are subject to inspection for safety.
There are regulations concerning approval, packaging, labeling,
use, storage, sale and transportation, production, import and
trade, advertising, fees, etc.
Law on Worker Protection of 1956 gives the government authority
to act against any product used in a work place. The main re-
sponsibility for safety remains with the employer, who is expect-
ed to exercise a large measure of self-control concerning use
and handling of chemicals. There are provisions for government
inspections, and the employer may be required to undertake in-
vestigations where a chemical substance is believed to be hazard-
ous to health. The Law has not in practice provided adequate
protection against hazardous chemicals, and is presently under
revision.
The Water Pollution Act of 1970 and the Neighbors' Act of 1961
(used in connection with air pollution and noise) can be
used to restrict introduction of chemical substances into the
environment from stationary sources, and are thus valuable
components in the overall control of chemicals.
The Act to permit limitations in the use of heating oil of 1970
allows regulation of sulfur content in the oil.There is also
an act governing the use of lead in paint, and regulations con-
cerning lead in gasoline.
Several laws govern control of food and feedstuffs and apply to
their quality as well as to additives and chemical residues.
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Most of these laws are designed to protect health against direct
exposure to hazardous chemical products. A few aim at prevent-
ing damage to the environment. These are either directed to-
wards narrow groups of products (as pesticides) or towards emis-
sions or discharges to air and water.
The Law concerning product control of June 11, 1976
The purpose of the Law is to prevent damage to health or distur-
bance of the environment by pollution, waste, or noise etc. from
any product. Product is widely defined as raw material, auxil-
iary substances and intermediate and finished products of any
kind, and measures may be directed towards production, importa-
tion, use and other handling of a product.
The law imposes a degree of responsibility on anyone who handles
a product, over and beyond existing general rules, by requiring
that the handler shall exercise care and take reasonable pre-
cautions to prevent and limit hazards. Moreover, manufacturers
and importers are specifically required to obtain such information
that may be necessary to determine whether the produce may pose
hazards to health or the environment.
The act authorizes the use of a wide range of regulatory measures.
Regulations may apply to any aspect of production, importation,
distribution, sale, labeling, use or other handling of a product.
Schemes for return of products, deposit, recycling or waste han-
dling may be mandated, and the composition or design of a product
may be regulated. Limitations on emission of pollutants or noise
may be set. Products may be subject to application for approval
before marketing, production or importation, or total prohibition
of these activities may be applied.
Anyone may be required to provide information necessary for en-
actment of the law. The importer or producer may also be required
to provide samples of products, or to undertake such investigations
as are necessary to determine the nature or effects of products,
and to cover the attendant costs. The authorities may themselves
decide to conduct investigations or tests, and may recover the
costs from manufacturer or importer when this is reasonable.
When it is considered necessary, temporary bans may be imposed
on production, importation, sale, use or any handling until
sufficient information concerning properties or effects of a
product has been submitted. The same applies when there is reason
to doubt the validity of previously submitted information. After
sufficient information has been produced, authorities must termi-
nate any ban within six months, except in special cases where the
period may be extended to 12 months.
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Products subject to registration requirements may be approved
on certain conditions, and approval may be voided if new infor-
mation or new interpretations of this information warrants
withdrawal. Permits may also be withdrawn in cases of willful
or negligent violations.
The law also contains provisions for inspection of facilities
and sampling of products, and general rules concerning observa-
tion of confidentiality. Confidentiality shall not restrain
dissemination of information concerning the effects of a
product. Provisions for punishment include fine and imprison-
ment, and under certain conditions a business entity may
partly or wholly lose its operating privileges.
A Product Control Council shall keep itself informed about prod-
ucts which may cause problems, and propose official action.
The Council shall also give a certain amount of guidance to
industry, and act partly in a decision-making and partly in an
advisory capacity. The Council shall prepare an annual report
to Parliament, which reviews past actions and decides on
programs.
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3.3.2 The Product Control Situation
In the preamble to the bill on product control, the Government
states that the control of chemical products is in general in-
adequate. However, certain chemical products are methodically
controlled.
Pesticides are subject to strict control, and the Ministry of
Agriculture's Poison Board by policy limits the number of prod-
ucts allowed on the market. The marketer must supply all infor-
mation necessary to assess a product, and in effect has the burden
of proof.
Drugs are also strictly controlled, and the marketer is required
to provide all necessary information. While the existing law
concerning drugs and poisons allows a certain degree of control
of other chemical products, both the law and the existing admin-
istrative capacity in this area are inadequate. Special permis-
sion is required to produce, import or export substances desig-
nated as poisons in the official "Poisons list", and certain
regulations apply to purchase, packaging and labeling of poisons.
Other less hazardous products are subject to rules concerning
packaging, labeling and sale to minors. However, chemicals are
not assessed in a wholly methodical way and environmental consid-
erations are rarely taken. The insufficiency of the present state
of affairs is cited as one main reason for enactment of the new
product control law.
In the occupational environment, several incidences of illness
related to chemicals underline the need for strengthening of
the law, stricter enforcement, and increased activity in method-
ical assessment and information to both employers and workers.
Regulations are in force to reduce the sulphur content of fuel
oil in industrial applications, and low limits have been set
for sulphur in oils for heating in two major cities. The geo-
graphical coverage may be extended in the near future.
Lead in gasoline has been set at 0.4 grams per liter, which is
less strict than U.S. goals. Auto emission control regulations
follow ECE regulations, which are generally more lenient than
U.S. requirements.
Drinking water facilities and drinking water quality are under
government supervision, =md food and feed is subject to govern-
ment control.
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3.4 Discussion
3.4.1 Legislation
In the U.S. numerous laws exist to protect health and the
environment from various categories of products with chemical
effects. The laws reflect various degrees of authority dele-
gated to administrative agencies, and some of the laws provide
the agencies with considerable discretion and flexibility. The
range of regulatory power vested in the laws ranges from wide
(the Clean Air Act, the Consumer Product Safety Act), to nothing
(the Solid Waste Disposal Act).
Periodic review of the laws and their bureaucratic implementa-
tion enables Congress to adjust the laws to political and eco-
nomic changes. This critical review process is probably more
far-reaching than in most western countries. Interest groups
are admitted to testify before Congressional Committees, ensur-
ing direct democratic participation. However, there is the
danger that interests may win influence disproportionate to
their number of supporters, more on the strength of their efforts
and resources than on the merits of their arguments.
All the mentioned laws reflect a strong concern for human health
(consumer product safety, pesticides, occupational health, foods),
and some are also aimed at protecting the environment (ex. pesti-
cides, air and water laws). Some laws regulate specific groups
of products such as pesticides or motor vehicles. Other laws
address products in particular areas of use, such as in the
occupational environment, or consumer products. Laws directed
at environmental protection (air and water acts) allow regula-
tion of the introduction of specific substances into the environ-
mental media, and the concentration of the substances in those
media.
Similar to the legislative situation in most countries, the
present set of laws does not meet demands for comprehensive
protective control of products. A large number of toxic sub-
stances can presently not be regulated, and this is probably
considered to be the most important issue in environmental
legislation today.
To illustrate the situation, consider the case of Polychlori-
nated biphenyls (PCBs), which presently are found in water,
fish, wildlife and domestic animals, foods, and human tissues.
The substance is known to have deleterious effects on organisms,
and is even a suspected carcinogen. It has been possible to
set limits for PCB contamination in foods, and EPA is investiga-
ting possibilities for using air and water acts to limit its
continued introduction into the environment. There is no basis
for regulating the production, sale, use and disposal of the
substance. If toxic substances legislation is passed in 1976,
it will probably become effective from late 1977.
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The U.S. laws tend to be rather specific and detailed. This
helps define closely what the authorities of the agencies are,
and may act as a control against unwarranted use of power. It
is also interesting to note the frequent inclusion of time
limitations set for completion of special tasks or goals. Such
specificity has the advantage that it promotes a certain degree
of action and promptness on behalf of the agencies. They may
be prodded into increased activity or swifter action by public
suits, and may similarly be curbed by court actions by industry
or other interest groups who feel an agency is going too far
too fast. Specificity requires consistency in the law, and
there are examples of inconsistencies between different sec-
tions within an act. Detailed statutes may also prove inflexible
in the face of unforseen problems.
It should be noted that.some of the modern laws specifically allow
for lawsuits by any person against responsible government agencies,
and call for public hearings before certain major decisions are
taken. These are probably rather unique features in law anywhere,
and they seem to assert the end of the era of passive acceptance
of government decisions. Legal challenge and public hearings are
conducive to increasing participation in societal affairs and are
valuable means of exerting influence on governmental actions. But
they may also be used as means for slowing down or postponing de-
cisions which should be made for the benefit of the general public.
An issue much debated in connection with chemical products legis-
lation is the question of which benefits and risks should be con-
sidered before a regulatory decision is made, and how these
factors should be weighed against each other. Whereas for ex-
ample the "Delaney clause" (which excludes carcinogens from
food) and the Clean Air Act do not call for consideration of
the economic and societal effects, many of the laws do require
such considerations. But it is not always clear just how benefits
and risks should be weighted, and the laws contain varying require-
ments. The problem is compounded when it is necessary to apply
more than one law in a particular situation.
Another important issue is the question of who has the burden of
proof when it is necessary to determine the hazards of a chemical
substance. At present, this burden of proof largely rests with
the regulatory agencies (with the exception of e.g. drugs and
pesticides). This means that, unless they can prove beyond
doubt that a substance is hazardous, it is very hard to restrict
its use even though indications of hazard may be strong. A
Toxic Substances Control Act is expected to clarify the question
of burden of proof, and impose information requirements on the
manufacturers.
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It is interesting to note, that no economic incentives or
disinsentives are mandated in present or proposed legisla-
tion. Given a growing disenchantment with restrictive regu-
lation, and economists' claims for the usefulness of taxation,
proposals for tax measures could have been expected.
The U.S. has particularly well developed laws in the consumer
product safety area and is probably ahead of most other
countries in this field. Also, the vehicle pollution control
statutes give the government substantial authority in that
area, and again this would rank as probably the most ambitious
in the world. On the other hand, general control of toxic
substances is deficient, and some countries have much more
advanced legislation for chemicals.
The Norwegian legislation before enactment of the new product
control law was in some ways similar in coverage to U.S. legis-
lation. The emphasis of Norwegian laws was also on health
more than on the environment, applied generally to the same
types of products as the U.S. laws, and they were not considered
adequate for satisfactory protection from products with chemical
effects.
The new law is designed to correct these shortcomings. It
provided general authority to regulate any product with chemical
effects, and therefore, overlaps much of the previous legisla-
tion. The new law is primarily intended for use in those area
where previous legislation did not provide coverage, and in
situations where broad coordination and comprehensive regula-
tory action is required. This arrangement generally leaves
existing agencies with their jurisdictions and well-established
functions unaltered, while ensuring complementation and coor-
dination of their efforts.
The most important laws in the area are generally enabling laws,
leaving considerable discretion to the agencies. There is
probably no precedence for time limitations or time requirements
on agencies in the laws.
Decisions involving risk/benefit assessments are generally made
by government agencies or their appointed committees, and are
rarely contested on legal grounds. The burden of information
and proof lies with the proponent of a product in the drug and
pesticides areas, and the proposed product control law estab-
lishes the principle for any product.
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Direct public participation and industry lobbying influence in
the decision processes concerning products with chemical effects
are still very limited, but participation by the various interest
groups is ensured by preview and comment on proposed laws and
regulations.
There is no provision in the new law for taxation as a tool for
product control. However, selective taxation can be imposed
by parliament.
Special attention is drawn to the product control law's provi-
sion concerning general responsibility and specific obligation
on the part of a manufacturer or importer to acquire information
sufficient to determine for himself whether a product may be
hazardous. The provision may become very useful in increasing
awareness and critical self-restraint in dealing with products.
Since government control cannot be fully effective, and should
ideally be very limited, it is important that industry and
commerce carry as much of the burden of control as possible.
The impact of the provision will depend on the regulations to
be developed and how they will be legally enforced.
A product control council with agency and interest group repre-
sentation has been proposed in the law. In addition to propos-
ing actions and making decisions, the council should facilitate
inter-agency coordination and secure a balancing of interests
and views.
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3.4.2 Actions and Approaches
There are two areas where particularly advanced programs have
been developed in the U.S. One is the EPA auto emission control
program, which is interesting because it illustrates a great
number of the product control principles discussed in Chapter
2, and because of its size, complexity and considerable
ramifications for other sectors of society. It is noteworthy
that Congress has been able to agree on such a significant pro-
gram, considering the opposing interests in this area. There
have been a series of strong political battles that have
obstructed the program, and there may still be some more. Also,
there are technological problems with the chosen catalytic con-
verter system such as the sulphuric acid mist, the proliferation
of platinum in the environment, and administrative hurdles con-
cerning compliance and enforcement of product in-use standards.
It has been said that time limitations set on the auto industry
for compliance with emission standards was too short, and that
this has forced the industry to choose a technology that was
possible to develop in a short time, but which is inadequate.
Given more time, the industry could have based control systems
on other and better principles. It seems that the federal
action is appropriate, because there are indeed few indications
that the industry would have made adequate efforts to develop
such a technology when needed. The present devices certainly
pose problems, but these are likely to be smaller than the
effects of unabated pollution would have been. Meanwhile, the
industry has the option to develop better systems.
The other area referred to concerns consumer products safety.
The program, as well as the law itself, are rather unique as
phenomena, and some very significant concepts and techniques
are likely to emerge from the program to benefit efforts in
other countries. The information systems, the participation
of groups outside the agency in standards development, the
manufacturers' hazard notification responsibility, and the
relatively strong compliance tools and sanctions, are some of
the features that make the program noteworthy.
The standards developed in the U.S. for occupational health
will clearly become an important basis for similar development
in other countries. Also, information on products and their
effects gathered under the program will be very valuable, and
should as far as possible be made available to foreign agencies.
But there is still a long way to go from having adequate regu-
lations to the point where compliance with the rules gives
satisfactory protection for the worker. To achieve this, some
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new concepts will probably have to be introduced to achieve
more self-enforcement of rules and more active participation
by the employees. Protection from occupational hazard also
depends on the development of better equipment for detection
and monitoring of chemical pollution.
Information needs in relation to toxic substances may be listed in
four categories: industrial data, exposure data, health effects data
and environmental effects data. In the present situation, the pri-
mary research emphasis is on health effects, followed by environ-
mental effects. Industrial and exposure data are by comparison
neglected areas, and more attention must be given to satisfy these
needs, both in the U.S. and elsewhere.
The very great efforts in research and assessment of the effects
of chemicals in the U.S. will be a major contribution on a world
scale. The U.S. probably has more capacity and output in this
area than any other country, and it will increase further as
industry will be required to perform more adequate testing.
However, a number of other countries have considerable activity
in these areas, and there is duplication of work. In view of
the enormous needs, better sharing of information and interna-
tional coordination of efforts is desirable.
Although principal authority for control of chemical products
is divided among four different agencies, there seems to be
a reasonable degree of coordination, partly because this is
required by law.
Generally, regulation of products with chemical effects appears
to be a much more politicized process in the U.S. than in Norway.
in the U.S., agencies are sensitive to political influence direct-
ly from Congressmen, the President via the powerful Office of
Management and Budget, and from industry lobbying groups and pub-
lic organizations. In Norway, governmental value judgements of
the kind involved in chemicals assessment tend to be far more
accepted as bona fide best available societal judgements. There
may be many reasons for this difference not to be discussed
here, but it is interesting to keep this difference in mind
when considering some of the attitudes and approaches to the
regulation problems below.
The basic approaches to product control in this area is similar
in the two countries, both have primarily chosen regulation as
the primary tool. This seems to be the only effective way.
(The disadvantages of taxation and voluntary agreements are
discussed in Chapter 2). Regulation has many disadvantages,
too. The process is slow, complex, and at this stage much
effort is required if we are to catch up with the needs. Reg-
ulation also implies more government interference. But ex-
perience has shown that interference cannot be avoided in any
case, and the sooner this can be accepted, the sooner the work
can proceed. However, it should be a constant goal to limit
the involvement to that which is strictly necessary. To achieve
this, mechanisms for engaging industry and commerce in self-
control through testing, assessment and participation in promul-
gation of standards should be further explored.
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A very important problem once regulations are adopted, is how
to enforce compliance. To enforce all the standards that have
to be developed is a very formidable task for any government.
The solution must be built on the highest possible degree of
self-enforcement by industry. Mechanisms must be developed so
that industry can monitor and keep records of products and
related activities, subject to government review and strong
sanctions in cases of non-compliance.
As discussed in Chapter 2, the burden of proof of safety should
rest on the proponent for the use of a product. But even where
the principle is applied, it does not solve all problems. For
example, recent findings in the U.S. pesticides program indicate
that manufacturers have manipulated test data to enable them
to "prove" the safety of the products involved. This forces
the agency to allocate valuable resources to a strict review
activity.
A difficult situation arises when there is no clear and irre-
futable proof either for or against the safety of a product.
This situation is common, and will be more so as more emphasis
is placed on protection from long term effects. Who is to
prevail, the proponent of use, or the regulator who feels there
is reason for grave concern but cannot disprove the submitted
"proof"? The question can be highlighted by such examples as
the case of the food additive red dye #2, which it has taken
FDA many years to ban, or the EPA lead-in-gasoline balancing
act in which the latest court decision upheld EPA 5 to 4.
It illustrates the problems of proof, even when most scientists
seem to agree that lead is harmful to health, and that auto
emissions account for the lion's share of exposure.
It is easy to see that if the same approach were to be used in
all future cases where clear proof is evasive, government
regulatory and judicial resources may well be exhausted while
attempting to protect public health. In the mentioned U.S.
cases, the proponent of the use of the chemical products are
seen as the defendants in the case, and by long tradition, the
defendant has the benefit of the doubt. This good principle
is in such cases misdirected. The true defendant is the public
whose right to continued good health is at stake, and the pub-
lic should be given the benefit of the doubt. This inevitably
points to the not entirely appetizing concept of increased
government authority to take restrictive action to postpone
or ban in cases of reasonable doubt. It is not an ideal ap-
proach, but it should prevail until the art of effect assess-
ment is sufficiently developed.
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4. NOISE ASSOCIATED WITH PRODUCTS
4.1 The Problem In General
Noise may be defined as unwanted sound. This infers that the
experience of noise is subjective, modified by mood, attitudes
and habits. When noise is related to actions that evoke fear,
the noise is perceived as very annoying. If noise is concom-
itant with a well paid job, the noise is more easily tolerated.
Individual susceptibility to noise irritation varies with
time, situation and from individual to individual.
The parameters that describe sound are sound pressure level
(intensity), pitch (frequency) and duration. Noise is commonly
a combination of tones of different frequencies. Sound intensity
is measured in decibel, dB. The following figure will indicate
how human response is related to sound levels. An increase in
sound level of lOdB is percieved by the human ear approximately
as a doubling of intensity.
Carrier deck |et operation
Jet takeoff (200 feet)
Discotheque
Auto horn (3 teet)
Riveting machine
Jet takeott (2,000 teet)
Garbage truck
N Y subway station
Heavy truck (50 teet)
Pneumatic drill (50 leet)
Alarm clock
Freight train (50 feet)
Freeway traffic (50 feet)
Air conditioning unit
(20 leet)
Light auto trallic (100 leet)
Living room
Bedroom
Library
Soft whisper (15 leet)
Broadcasting studio
Noise
level
140
130
120
110
100
90
80
70
60
50
40
30
20
10
0
Hearing Conversational
Riispon e elfects relationships
f~
rdimuny lutiu „
Limit amplified speech §
O-
e
CT
Maximum vocal elfott s
X
o
§ Shouting in ear
Very annoying Ł
3 Shouting at 2 leet
Very loud
Annoying conversation, 2 teet
Loud
Telephone use dillicult -*•- conversation, 2 leet
Intrusive L0ufj
conversation, 4 leet
Normal
Quiet conveisation, 12 leet
Very quiet
Just audible
Threshold ol ncarmq
Gouei Mint-in PIIMIHH) 0(fi«- 1974 n
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Effects of noise may be divided into two categories, one concerns
direct effects on hearing, the other concerns physiological and
psychological effects. Direct effects on hearing may take the
form of disturbance of desirable communication, or hearing im-
pairment due to very high exposure or protracted high exposure.
Physiological effects may include changes in heart rate, blood
pressure, metabolism, or depressed respiration, sleep distur-
bance and tiredness. Psychological effects include depression
and irritation.
Apart from the direct physical and psychological effects, noise
may be hazardous in other ways. Noise from a device could pre-
vent the user or others in the vicinity from hearing an auditory
warning signal. Likewise, a noisy product may prevent the user
from detecting a mechanical malfunction. A noisy device might
distract the operator and others from the demands of the task
which they are performing, or it may increase the level of
fatigue or irritability which again may result in accidents.
Knowledge about the effects of noise on animals is presently in-
sufficient, but physiological changes have been observed. There
are several reports of cases where animals such as skunks and
minks have eaten their offspring when disturbed by airplanes or
explosions. Conversely, it seems that some animals have a great
ability to adapt to high noise levels.
Among all the noise sources, transportation is probably the most
significant in terms of numbers of people affected. Of these,
road transportation is likely to be responsible for the greater
portion, but also aircraft, railway and to some extent shipping
activity are significant noise sources. Noise from transporta-
tion sources represents a problem both in the outer environment
and for the passengers transported.
Noise from road transportation devices has become a significant
factor of an urban and rural areas. It is estimated by EPA that
more than 50% of the population are adversely effected by road
traffic noise. A statistical survey of housing conditions in
Norway in 1973 indicate that 18% of the population are adversely
affected indoors by various forms of noise from neighbors and
from road traffic combined. Road vehicle noise is caused by
the motor, the interaction between tires and the roadway, and
air friction. Motor noise is prevalent at lower speeds, and
the other types of noise are more significant at speeds above
50 to 90 kilometers per hour depending on conditions. Noise
can be reduced by shielding motors, muffling exhaust and use
of low-noise tires. Aircraft noise severely effects people
around the airports, and EPA estimates that 24.5 million neigh-
bors are adversely effected in the U.S. In Norway, severe
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conditions are found in certain localities. Significant
improvements can be made by sound damping devices on existing
aircraft, and by phasing out older noisy aircraft in favor of
newer, quieter types. Aircraft noise is much dependent on
how and when planes are operated, and much can be improved
by changing operational procedures.
Noise from railroads primarily comes from motors of non-electric
locomotives and impact between wheels and rails. Significant
improvements on noise can be made with present technology.
Over the last years there has been a marked increase in the
number and use of various recreational transport devices such
as pleasure boats and snow mobiles. These can be sources of
major annoyance, both because they may emit much noise and
because they tend to be used in areas where people withdraw
from everyday life to experience peace and quiet.
Construction activities are major sources of noise from such
products as compressors, jack hammers, earth moving equipment,
pile drivers, etc. It is estimated that such noise daily effects
some 26 millions americans. Also in this area, significant noise
sources and by changing use patterns. Around 20 millions workers
in the U.S. in construction and other occupations are exposed to
noise levels that pose a threat to their health and well being.
Of these, around 8 1/2 millions workers are exposed to noise
that entails immediate significant risk of hearing impairment.
In Norway, a 1973 Trade Union survey disclosed that 27% of
workers sited noise as the cause of personal injury or illness.
In this area too, much can be done to reduce harmful noise.
However, some of the industrial processes are by their nature
noisy (grinding, milling, metal stamping), and cost of improve-
ment are considered relatively high. Agricultural machinery
may also be a major noise source, for the operator as well as
surrondings.
Sundry home appliances and craftsman equipment expose a large
part of the population to noise levels which interfere with
communication and ability to enjoy domestic quiet. Some of
them also have the potential for adversely effecting hearing,
and power lawn mowers may present this threat as well as creat-
ing environmental noise problems. Again, significant reductions
maybe anticipated by design changes.
The noise problem can in most cases best be tackled by controlling
the sources of noise; very often the source is a product. Source
reduction seems to be the best approach from the view point of
setting standards, and lends itself well to cost-benefit analysis.
Control of the general noise situation and enforcement is made
simpler by source reduction than by other means. There is
substantial technology available for control of noise from
products, and where this is not sufficient, changes is use
patterns maybe imposed.
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4.2 U.S.A.
4.2.1 Major Legislation
The Noise Control Act of 1972
The Act represents the first major Federal attempt to eliminate
excess noise at the design stage of a wide variety of products.
EPA is directed to develop and publish information on limits of
noise required for protecting public health and welfare with an
adequate margin of safety, to issue reports identifying products
that are major sources of noise, and to give information on the
techniques for controlling noise from such products. EPA is
given broad authority to obtain from manufacturers the informa-
tion it needs to implement the Act.
EPA is further required to set noise emission standards for prod-
ucts that have been identified as major sources of noise and for
which standards are deemed feasible, taking into account costs
and available technology. The law specifically requires noise
emission standards for products in the categories of construction
equipment, transportation equipment (except aircraft), all motors
of engines, and electrical and electronic equipment.^ It also
grants authorities to set standards regarded as feasible and
necessary to protect public health and safety for other products.
EPA has authority to require the labeling of domestic or imported
consumer products as to their noise generating characteristics
or their effectiveness in reducing noise. Fines are levied
against those responsible for non-conforming or mislabeled
products. Manufacturers must issue warrants that their regu-
lated products comply with standards at the time of sale. They
are also required to maintain records and provide information,
and samples of products.
In addition to setting product performance requirements, EPA is
to prescribe noise emission standards for the operation of the
equipment and facilities of interstate railroads, trucks and
buses. In-use noise problems from products will generally be
controlled by state and local government.
EPA is to submit proposed regulations to control aircraft and
airport noise to the Federal Aviation Agency (FAA) which shall
consider them prior to prescribing the same regulation, a
modified regulation or no regulation. If EPA believes the FAA's
action does not protect the public health and welfare it may re-
quest the FAA to review its decision, and make public the reason
for its action.
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The Act gives responsibility to EPA for coordinating and acti-
vating the capabilities and noise control policies of other
Federal Agencies. EPA's ultimate authority, if it disagrees with
an Agency's final action, is to appeal the case to the Council
on Environmental Quality (CEQ). Under the Act, EPA's authority
is not restricted to environmental noise, but covers also prod-
ucts in the workplace and consumer products.
The Federal Aviation Act of^ 1968 empowers the Federal Aviation
Administration to precribe regulations for the control and abate-
ment of aircraft noise. The legal authority covers aircraft noise
emission levels as well as operating rules. Economic and techno-
logical considerations must be taken in the formulation of a
standard. By amendment in the Noise Control Act of 1972, EPA
has certain powers concerning air traffic noise.
The Occupational Safety and Health Act of 1970
Reference is made to the presentation of this law under section
3.2.1. According to the Act, the Occupational Safety and
Health Administration (OSHA) has the final authority to set a
workplace noise rule (EPA has certain authorities of request
for review and appeal, as mentioned above).
Basically, compliance with an occupational noise standard may
be attained through the use of personal protective equipment,
administrative controls involving rotating workers out of high
noise areas, or by shutting down machines for a time, or engineer-
ing controls to quiet noise at the source by enclosing a machine
or redesigning equipment. The effect of the Act on products used
in the workplace is accordingly indirect through engineering
controls. Direct regulation of products such as machinery and
equipment is under EPA authority.
The Consumer Product _Sa_fety Act of 1972
Reference is made to the presentation of this Act under section
3.2.1. The provisions of the Act are applicable to any product
which poses an unreasonable risk to safety or health, and will
therefore apply to products whose noise characteristics consti-
tute such risks.
Federal Hazardous Substances Ac^tf as Amended by the Toy Safety
Act of 1969
Reference is made to the presentation of this Act under section
3.2.1. The Toy Safety Act provides for regulation of products
that may cause hearing damage to children.
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4.2.2 The Product Control Situation
EPA started regulation of products in 1974, with heavy motor
carriers engaged in interstate commerce. Regulations are also
being promulgated for locomotives and railroad cars, and for new
portable air compressors and new medium and heavy duty trucks.
Whereas requirements for railroad performance do not seem to be
particularly strong, noise from the other mentioned product groups
will be significantly reduced. Officially identified for future
regulation are motorcycles, buses, earth moving equipment and
special auxilliary equipment on trucks. The full effect of prod-
uct control measures will only be achieved after a number of years,
owing to turnover time for existing products.
Control of noise from consumer products has only just begun.
The Consumer Products Safety Commission (CPSC) has issued regu-
lations on play items that create explosion noise impacts such as
toy caps, etc. EPA plans to study noise problems related to such
consumer products as small engine powered equipment, electrical
and electronic equipment, and the general categories of household
appliances and industrial eqiupment during 1976. Regulations may
be forthcoming in two to three years. CPSC is working on safety
regulations for power lawn mowers, and restrictions on noise
emission may be included.
While OSHA has authority to regulate noise levels in the occupa-
tional environment, EPA will study noise abatement technology
and possibly regulate industrial machinery through new product
regulations. Such regulations may be forthcoming in two to three
years.
The Federal Avaiation Agency (FAA) requires by regulation that all
new jet-propelled transport plans not exceed specified noise levels,
In 1974, only 10% of existing aircraft met FAA new aircraft stand-
ards. However, modification of noisy aircraft is technologically
feasible. In 1975, EPA proposed a retrofit regulations that
would require all existing airplanes to comply. Later, FAA has
proposed more limited retrofit action, and the Air Transport Associ-
ation of America has made a proposal to modernize part of the exist-
ing fleet to reduce noise. In all cases, federal loans or quaran-
tees are implied. The Department of Transportation has not made
any official decision (May 1976).
Existing regulations do not prohibit super sonic aircraft (SSTs)
from operating at U.S. airports at subsonic speeds, and a 16-month
trial operation of SSTs began in May 1976.
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4.2.3 The Environmental Protection Agency
EPA embarked on its noise control program by analyzing the noise
situation in the country, arriving at information on the number
of persons impacted from different sources, and at what levels.
A very important corner stone for a balanced and pragmatic approach
was laid by the completion of the "levels" document in March 1974,
which identifies "Noise levels requisite to protect public health
and welfare with an adequate margin of safety."
The general goal of the presently planned noise abatement program
of the EPA is to reduce the impact of noise pollution by minimiz-
ing the incidence of:
-Noise induced hearing loss
-Sleep loss from noise
-Noise inference with speech communications
-Annoyance from noise
Through a system of weighting of the number of people exposed to
noise, and the degree of noise exposure, these quantities are
converted into nominal numbers (called impact units) representing
the number of people one hundred percent impacted by noise (i.e.
up to the levels considered requisite to protect public health
and welfare) from different noise source categories. The general
goals mentioned above have subsequently been expressed in numer-
ical terms. As an example, EPA assumes 112 million noise impact
units in 1992 if no noise reduction measures are taken, and aims
at reducing this to 17.5 million noise impact units by 1992).
This overall figure is split up in different noise source cate-
gories and specific reduction goals are formulated for each one.
The goals will be accomplished by regulations on maximum noise
emissions from products, labeling, information to the public, coop-
eration with states and local governments and coordination of fed-
eral noise programs, and research. By 1992 it is assumed that all
major sources are regulated, that almost all of the old noisy units
manufactured before regulation will have been retired, and that
noise from products will be at low, long term steady state values.
At that time, EPA will put relatively more emphasis on enforce-
ment, leadership in providing technical assistance and support of
state and local programs, coordination, research, and improvement
in existing regulations.
Before regulations may be published for any product, the product
must previously have been formally identified as a major source.
To do this, EPA makes a technical analysis of noise impact for the
product type in question, and compares this to criteria in the
"levels" document. Depending upon the severity of the impact,
products are either designated major noise sources, or considered
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as candidates for labeling, or not considered for regulatory
action. The results of this analysis are weighed along with
such factors as available technology, costs, voluntary actions,
time requirements, etc. Once a product is publicly identified
as a candidate for regulation, EPA must publish reports giving
information on techniques for control of noise from that product,
including data on the technology, cost and alternative methods
of noise control. Further, EPA must publish proposed regulations
within 18 months and final regulations within 24 months where
regulation is feasible. In cases where regulation is not feasi-
ble, EPA may decide on a labeling requirement or on no action.
Formal identification prior to regulation serves two purposes:
One is that once a problem has been identified, society is
assured that corrective action will be taken within reasonable
time (on the other hand, EPA may theoretically choose to ignore
a problem and hence not identify it). The other is an effect of
positive value to manufacturers, who by the formal identifica-
tion of products as major noise sources receive warning of impend-
ing change. The 18 month period gives opportunity for the manu-
facturer to study or effectuate changes in his products if he so
desires.
Informing the public about the noise emission characteristic of
products is expected to become an important element in the EPA
noise program. Required labeling with information on noise emis-
sion from a number of outdoor and indoor consumer products will
give the purchaser opportunity to choose a quieter product/ and
it will give manufacturers an incentive to reduce noise emissions
to avoid adverse sales development. Labeling may also contribute
to a keener public awareness of noise, and may contribute to
attitutes essential to reducing the noise problem.
The information program will also aim at educating the public
about how to avoid discomforting exposure to noise and danger
of hearing loss from voluntary exposure to electronic equipment
(amplifiers, hi-fi sets, etc.) and other noise sources.
As is the case with pollution emission control from cars, the
EPA noise enforcement strategy places a major share of responsi-
bility on the manufacturer for pre-sale testing to determine
compliance with noise standards. It is felt that this has both
the advantage of letting the manufacturer retain control of many
aspects of a compliance program, while reducing government inter-
ference to a minimum. The program involves product verification,
under which products intended for marketing are tested in order
to verify that a manufacturer has the requisite noise attenuation
technology in hand and is capable of applying the technology in
his manufacturing process. The testing will be done in accordance
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with EPA test procedures. EPA reserves the right to be present
during testing, and the manufacturer is requires to file a pro-
duction verification report before any sales of the product. Such
reports are also required when a previously verified product is
significantly changed. To further secure that products comply
to regulations, assembly line vehicle testing is included in the
enforcement strategy.
According to the program strategy being planned, a special audit
staff will select the manufacturers and products to be tested,
prepare the test orders, monitor compliance, and perform such
testing as may be required. The staff will also take appropriate
actions in the case of nonconformity, and conduct investigations
as necessary. EPA will retain free access to all production,
testing and storage facilities.
It is essential for the achievement of noise reduction goals that
a product not only conform to emission standards when new, but
also during its useful life. Similar to what applies to the
auto emission control program, the noise program requires the
manufacturer to provide a warranty to purchasers, and to
recall products for technical changes. Manufacturers will be
required to provide purchasers with instructions specifying the
maintance, use and repair required to assure conformity with
regulations. There will also be provisions against tampering
which alters the noise emission properties of the product.
A strong compliance tool is the authority to require the manufac-
turer to recall products. Recall would be required when a pro-
duction verification is not submitted and the product is found
not to conform with standards. It may also be used when audit
tests reveal non-compliance with regulations, and when properly
maintained and operated vehicles fail to conform to in-use
standards.
On aircraft noise, EPA has assessed the current FAA flight and
operational noise controls, noise emission controls, and possi-
bilities for retrofiting or phasing out existing aircraft. EPA
has also studied control measures available to airport operators
and local governments and the implications of establishing cumula-
tive noise level limits around airports. The studies have resulted
in several proposed regulations directly concerning noise emissions
from aircraft. While implementation of these aircraft source noise
regulations will bring considerable relief to a large sector of the
noise impacted population, they alone will not eliminate the prob-
lem. EPA has therefore also proposed regulations on take-off
and approach procedures, and airport regulations.
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The Act requires the Secretary of the Treasurer to issue a regu-
lation that will ensure compliance for imported products, and
EPA is to enforce them. As with the Clean Air Act import program,
the strategy will be to require labeling of imported products to
simplify'customs procedures. Products made solely for export
will not be covered by U.S. noise standards. Because of the
trans-frontier pollution aspects of air and surface trans-
portation, and in view of expanding international trade in
noise-emitting products, a part of EPA's noise abatement pro-
gram will be devoted to harmonization of product noise regulations.
EPA is establishing a long term noise monitoring program to be
implemented ultimately within the ten federal regions. The main
purpose of this program will be trend monitoring of the noise
program's measure of effectiveness, as expressed by the reduction
of the national noise impact. The noise levels in 8 categories
of noise sources will probably be measured every 3 years from
aircraft operations, urban motor vehicle traffic, highway traffic,
construction equipment, railroads, industrial noise, home appli-
ances and equipment, and noise within transportation vehicles.
The principal responsibility for enforcement of federal noise
standards and labeling requirements lies with EPA. However, state
and local governments can assist enforcement through in-use con-
trol of regulated products if their laws properly complement fed-
eral regulations. State and local governments can also assist
the federal government in enforcing warranty and anti-tampering
provisions of federal regulations. The Department of Transporta-
tion (DOT) has responsibility for enforcement of interstate rail
carriers and interstate motor carriers.
Public participation in the development of regulations, both for
noise emission and labeling, is required in the EPA program.
The budget for the EPA noise program calls for around 10 million
dollars per year in 1976 and 1977, the number of positions around
90.
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4.2.4 The Consumer Product Safety Commission (CPSC)
CPSC has authority in noise control according to the Consumer
Protection Safety Act and the Federal Hazardous Substances Act.
A presentation of CPSC and some of its program aspects is given
in section 3.2.6.
Possibly as a consequence of EPA's dominating role in control
of product noise according to the Noise Control Act, noise
connected with consumer products is not top priority in the
Agency. The noise problem has been addressed for such products
as toy explosives for children, where permanent hearing damage
was considered a serious and unreasonable risk.
The NEISS injury reporting system, which collects a fundamental
portion of hazard information for the Agency, does not regularly
pick up reports of hearing damage from noisy consumer products.
This is partly due to the fact that even severe hearing damage
is not regularly referred to hospital emergency rooms, and also
due to the fact that hearing loss is often very gradual
and, therefore, not perceived by a person as being caused by
exposure to noise from products.
The Agency also gives priority to noise from products which also
pose a safety hazard, and where the noise may increase this
hazard. One such example is power lawn mowers, from which noise
may tend to mask warning signals to the operator, and thereby
increase the safety hazard. In this example, regulation of
noise is incidential to safety considerations, and does not
cover the wider environmental aspects of the noise.
4 . 3 Norway
4.3.1 Major Legislation
The Road Traffic Act of 1965 contains provisions for regulating
vehicle noise.
The Bui IdjLng Law of 1965 gives a basis for the incorporation of
noise considerations Tn land use planning, and there are regula-
tions concerning noise insulation of buildings.
The Neighbors ' Act of j-°sl sets limitations for the individual's
activities in consideration of his neighbors. The law is used
to control noise from industries by issuing permits. (See also
section 3.3.1)
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The Health Act of 1860 may be used to restrict activity that
may be hazardous to health. Oslo city has used the law to
issue a noise ordinance.
The Worker Protection Law of 1956 contains provisions concerning
1imitations of noise* and vibrat ions. (See also section 3.3.1)
The law concerning product control of June 11 r 1976^ is presented
in section 3.3.1. The law will make it possible to regulate
products that cause health hazards or create disturbances to man
or in the environment by emitting noise. Regulations may take
the form of performance standards, use regulations or other
measures.
4.3.2 The Product Control Situation
Statistical information on exposure and effects of noise is not
widely developed/ but the two surveys mentioned in section 4.1
involving indoor noise and workers, in addition to certain local
investigations, indicate that noise is likely to receive more
attention in the following years. The noise situation and the
need for control measures are presently under study by the
Ministry of Environment.
The only products for which regulations are in effect are motor
vehicles.
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4.4 Discussion
4.4.1 Legislation
With the amendments to the Federal Aviation Act, the Noise
Control Act in 1972 has given the government important, broad
powers to attack noise. While much of the power to control
noise from the use of products (and ambient noise) rests with
the states, the legislation will otherwise be sufficient to
control noise from products.
The Noise Control Act is primarily a product control law. Al-
though there is need to control ambient noise from the use of
products, and from stationary sources, these have been percieved
more as local concerns. This, and the fact that federal engage-
ment in noise is of recent date, may account for the somewhat
less ambitious role in local noise control than in other areas
of environmental protection.
The act prescribes that standards shall be adequate to protect
public health and welfare, due consideration being given to
available technology and the cost of compliance. As is the
case with laws pertaining to chemicals, the law does not detail
further criteria for balancing these factors. This lack of
specificity may bring about court action by industry to contest
new regulation.
Congress has expressly listed four categories of products to be
addressed, one category is electrical and electronic equipment.
This means that the law not only applies to products polluting
the outdoor environment, but also those that create,noise prob-
lems indoors. Also other products than those in the four
categories may be regulated. This wide scope makes it possible
to base regulatory actions on a comprehensive assessment of
the noise impacts people are subjected to, and accordingly
ensure a reasonably balanced total effort.
As in other modern laws, the Noise Control Act gives any person
the right to sue another person to restrain a violation of the
Act, or sue EPA or FAA to compel the performance of a mandatory
duty under the Act. To ensure timely agency action, time require-
ments for regulations development are spelled out in the law.
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Related to the question of burden of proof, the question of
what noise restrictions are necessary to adequately protect
health and welfare may be hotly debated as more economically
significant regulations are introduced. In requiring EPA to
develop information on this subject, Congress has implicitly
charged EPA with the burden of proof in the noise field.
The Norwegian product control law contains the possibilities for
control found in the U.S. Act, and will further allow in-use con-
trol of the products. This will give an even better basis for
a balanced approach to regulation and enforcement. The specific
obligations of the manufacturer or importer to determine whether
products may be hazardous or cause excessive disturbance can be-
come an important aspect in product noise control. For this
mechanism to be effective, some consensus on significant noise
criteria must probably be spelled out in an official document.
There is no provision in either the U.S. Noise Control Act or
the Norwegian Product Control Law to authorize the use of taxes
to reduce product noise. The U.S. emphasizes the use of noise
labeling as a means towards noise reduction. Similar action
may be taken under the Norwegian law.
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4.4.2 Actions and Approaches
EPA has started an advanced program that will be significant
on a world scale.
In connection with standards presently being developed, high
costs or lack of technology has not been much of an issue.
The reason is that the requirements appear to be somewhat cau-
tiously set to match easily available, low cost technology.
The situation in relation to noise regulations may become con-
siderably more polarized when more requirements are set to
attain the recommended exposure levels, more similar to circum-
stances in the chemical products area.
The "levels document" (section 4.2.3) will probably come under
fire when regulations become more restrictive. It is interesting
to note that at least it may be possible to describe such levels
and use them in practice. (This is presently far less likely for
chemicals). The development of the document seems to be a logi-
cal first step for methodical control.
As compared to other areas of product control discussed in this
study, it is relatively easier to predict the degree of improve-
ment from a given control program in the noise area. EPA attempts
to make improvements by a worst-first approach and a general,
parallel reduction of noise emitted from all types of products.
The requirements imposed by the law will largely be in the
form of product performance standards, limiting the amount or
frequency of noise emitted. If carried sufficiently far, this
could practically eliminate noise. A number of factors make
this impossible or even unnecessary, and products will continue
to emit some noise. Hence there will always be a need to con-
trol the use of products so that lawn mowers do not needlessly
disturb the Sunday morning peace, or so that snowmobiles or dune
buggies will not shred the quietness people seek in the outdoors.
Successful control of the noise problem in the U.S. depends on the
active participation of local governments, and a very active fed-
eral program of guidance to states' noise programs is necessary.
In the federal noise control program, regulation of product noise
emission has been chosen as the main tool, and this seems to be
the best way. The U.S. program plans seem to recognize the
importance of self-enforcement by requiring the producer to do
the testing, to evaluate his own technological ability to make
products which are in compliance with standards, and to keep
records, all subject to government audit. Aircraft noise has
been a politically significant issue for some time, cost and
technology have been important factors to slow down noise
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improvement. While new jet engines are significantly better than
their precursors, the older engine types will be in operation
for quite some time. Consequently, any early improvement in
noise impact from planes is contingent upon retrofitting, or
modification, of older type engines. It may be very difficult
to implement this if the federal government does not decide to
foot some of the bill.
The effects of information to the consumer about a product's
noise emission characteristics may have good effect particu-
larly when choosing among indoor products that will directly
affect the buyer's noise situation. A consumer is somewhat
less likely to consider the noise characteristics of an outdoor
product as similarly important. Much depends on a person's
ability to relate dB-values to annoyance, and how lower dB values
will be valued in economic terms.
By statute, EPA is the center of responsibility for federal anti-
noise activities. This gives a very good starting point for
coordination and a comprehensive approach to noise control.
Because of an early start, and considerable scientific capacity,
the U.S. noise program will yield very valuable information on
effects, control technology, costs and other aspects. This
information, and the regulations developed from it, can be
put to good use in other countries.
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5. WASTE EFFECTS OF PRODUCTS
5.1 The Problem in General
Wastes are essentially superfluous material or energy from pro-
duction or use of products. Waste is a relative term, since
factors such as economics and supply and demand determine
what is considered superfluous at any given time. Supply is
governed by such factors as availability of natural resources,
efficient extraction technology, and politically determine
conditions. At this time, many of these factors are generally
favorable to the use of virgin materials, rather than to
material economy and extensive recycling.
Wastes create health and environmental hazards: sanitary prob-
lems, pollution of water, air and soil, and in some cases accumu-
lation of toxic substances in plants, animals or man. Increasing
amounts of wastes claim more land for new disposal, and there are
costs connected with handling and treatment of waste. Wastes may
also contribute to deterioration of the quality of life by aesthet-
ic impact. It is usually possible to identify production processes
or products, or unsatisfactory waste management, as sources or rea-
sons for waste problems. Improved management practices and in-
creased emphasis on potential waste problems during product devel-
opment and product use are important ways of avoiding unwanted
impacts. The following simplified sketch shows the major alter-
natives for waste control:
Emission or discharge
(air, water, soil)
Storage,in some cases
followir» pretreatment
-^Recycling
Nature's cycles (air.water, soil)
without damaging p.otlution
Technologica1
use
Re-use for same purpose]
New products
J
Direct use of waste
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The term "storage" covers land fills, more specialized storage
for the purpose of security or later recovery, and any pretreat-
ment applied to the waste to facilitate storage. Recycling
(sometimes referred to as resource recovery), includes return
of materials to nature in a way that does not cause pollution
problems (for example by reducing organic materials to soil
improvement components)/ or direct reuse of the product for its
original purpose or as input resource for new materials (includ-
ing energy), or direct use of the waste for some beneficial purpose,
The manufacturers' emphasis on economical production and distri-
bution, and on marketing-oriented saleability aspects of the prod-
ucts have contributed to increasing waste problems. Little re-
gard has been afforded the products' potential for giving rise
to undesirable wastes.
Application of appropriate product control measures will cause
industry to apply criteria for product development which will
improve the waste situation. Product design can thus be geared
to reducing the quantity of wastes. By changing the composition
of products, it is possible to remove hazardous or undesirable
components from wastes. This can make the wastes more suitable
for municipal treatment by avoiding products that decompose
slowly, or give rise to polluting leachates or gases. Changes
in composition of products can facilitate materials separation
and make wastes more easily recyclable. Today, mixed materials
use (such as plastic/paper laminates, steel/aluminum combinations
in cans) is an obstruction to recycling. Restrictions on the
amounts of throwaway or non-returnable products would be effec-
tive in reducing wastes and stimulating recovery. Recovery may
further be enhanced by standardization of packaging and imposi-
tion of deposits or taxes.
Labeling with information concerning environmental effects and
correct waste disposal could also diminish some waste problems.
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5.2 U.S.A.
5.2.1 Major Legislation
Reference is made to the presentation of the Solid Waste
Disposal Act of 1965 as amended by the Resource Recovery Act
of 1970 in section 3.2.1. The Act authorizes EPA to issue
guidelines, some of which are mandatory for federal facilities,
There are no mandatory product control requirements in effect.
The Marine Protection/ Research and Sanctuaries Act of 1972
and the Safe Drinking Water Act of 1974 applies to disposal of
wastes, but have noprovisions directly concerning product
control (section 3.2.1).
5.2.2. Proposed Legislation
Several bills concerning wastes have been proposed in the later
years. It is presently difficult to predict when a law will be
passed, and what provisions it will contain. Two proposals are
described below to give an impression of the issues discussed
by legislators.
The Senate Bill S.1744 of 1975 proposing the "Resource Recycling
and Conservation ActĄcontains provisions for reducing the quanti-
ties of waste. The bill is based on the then recent experience
of shortages of food, energy, and other products and materials,
and the emphasis is on conservation of virgin natural resoures,
promotion of resource recovery and recycling, and reduction
of waste through the efficient use of energy and resources
short supply. The Act would authorize the use of fees, product
mix standards or other means found suitable to encourage the
durability, recycleability or reuseability of a product. Only
such products which are identified as contributing to the use
of unreasonable amounts of energy or virgin materials, either
critical for the national welfare or in actual or potential
short supply, would qualify for regulation. The main focus of
the bill is on conservation, but certain secondary effects of
this would have beneficial health and environmental effects.
A House of Representatives staff version of the Solid Waste
Utilization bill of December 1975 embodies aspects common to
several bills/ ancT some modern approaches to waste control.
The bill calls for government demonstration and construction
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of solid waste management and resource recovery systems, and
provision of technical and financial assistance to state and
local governments in planning and developing such systems.
National research and development programs would be established
for management and organization, and technical methods of col-
lection, separation, recovery, recycling and disposal of solid
waste would be developed. There would be incentives for energy
and materials recovery. Proper management of hazardous waste
would be promoted in various ways. Permits would be required
for transport, treatment, storage or disposal of hazardous waste
requiring disclosure of information concerning quality and
quanity of waste, location of facilities and methods for treat-
ment. Generators of hazardous waste would be required to main-
tain records of waste and related activities, to follow correct
disposal procedures, and to use appropriate labeling and containers.
No direct controls are envisaged to reduce hazardous waste by chang-
ing production processes or products, but mandatory labeling in-
structions for waste disposal may become a positive factor. To
discourage the manufacture, distribution and disposal of products
using an unreasonable amount of virgin materials, product regula-
tions are proposed. Such regulations may encourage increased
durability, recyclability or re-usability of products by manda-
tory standards or fees. To reduce the volume of waste from
packaging, a charge is proposed on the sale of packaging prod-
ucts corresponding to the cost of handling such waste. To
further encourage recycling of materials, a time limited subsidy
is proposed for products which contain post-consumer secondary
material. The funds accrued by charges under the Act would be
used to provide grants to states for development of solid waste
programs.
5.2.3 The Product Control Situation
The situation concerning hazardous chemical wastes was briefly
mentioned in section 3.2.3.
In connection with litter and other types of waste problems,
post-consumer product wastes are important. EPA estimates that
around 700 kgs of such wastes are created per capita per year,
estimated to rise to 1100 kgs per capita per year in 1990.
This is a very high figure compared to other nations (in 1972, a
largely corresponding figure for Norway is approximately 300 kgs)
In the U.S., about 7% is recovered partly as reuseable material,
partly as energy.
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Rising costs and decreased availability of conventional fossil
fuels have tended to make solid waste an attractive energy
source. The costs of conventional disposal methods such as
sanitary land fill and incineration have continued to rise.
The value of recoverable waste materials, particularly scrap
metal and paper/ has had some upturns in the last years. These
factors have increased the interest in the use of municipal
solid waste as a source of energy and of recyclable materials,
to a limited extend lessening waste disposal problems. In the
present economic system there are, of course, no controls of
prices on virgin or recovered materials, and prices have fluc-
tuated widely. Resource recovery governed by prices set by
supply and demand can hardly be counted on as a stable founda-
tion for reducing environmental waste problems.
Contrary to conservation and accompanying environmental goals,
several economic factors now favor virgin production. One is the
fact that i.a. virgin timber profits are treated as capital gains
for tax purposes, an advantage that is not available for waste
paper. There are also certain depletion allowances for processors
of virgin materials. Another is the practice of assessing solid
waste management costs against municipalities and their general
tax funds rather than against those who generate the wastes. This
favors the wastemaker and discourages recycling of paper and other
materials. In some cases, rail freight rates have been biased
against recycled materials.
Littering of natural areas close to cities and suburbs has
reached appalling proportions in many areas. The more conspic-
uous items are car bodies and household appliances, the most
numerous are non-returnable glass, metal and plastic containers
of various kinds, and automobile tires.
Despite many obvious problems, Congress has been unable to pass
legislation to regulate waste management or the quantity or
properties of products that create waste problems. As of mid
1975, three states, Oregon, Vermont, and South Dakota had laws
restricting beer and soft drink containers and Minnesota had
a law affecting all major types of packaging waste. Despite
positive experience with, for example, the Oregon law, labor,
retailers and industry are still intensely opposed to similar
bills. At present, there seems to be little chance for federal
product regulations that would be displeasing to manufacturers.
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5.3 Norway
5.3.1 Major Legislation
Before passage of the new product control law, the legislative
basis for regulating the waste and littering aspects of products
was rather limited.
The law concerning authority to ban the use of certain types of
non-returnable containers for consumer goods of 1970 has not
hitherto been used for regulation.
A temporary law concerning deposit for containers for beer and
other soft drinks of 1974 is used to regulate returnof glass
bottles.
Law on nature conservation of 1970 and the Road Act of 1963 have
general provisions prohibiting littering.
Law concerning sanitation tax of 1924 empowers municipalities
to enforce mandatory sanitation.
The law on product control of June 11, 1976 (see section 3.3.1)
can be used to control waste problems from any type of product.
It gives authority to regulate production, importation, sale,
labeling, use and other handling of a product. It authorizes
mandatory return and deposit schemes, waste source reduction
and handling requirements. The design or composition of products
may be altered by performance standards or more specific require-
ments, and products can be banned if necessary.
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5.3.3 The Product Control Situation
While the magnitude of waste problems may be somewhat less
than in the U.S., a number of specific or local problems
need be addressed. Available figures may have a somewhat
different basis, but it seems that the quantity of post-
consumer waste is about 1/2 of the amount in the U.S.
No adequate information on littering is available, but a sub-
jective judgement indicates that the problem is somewhat more
adverse in the United States. The litter situation along the
long coast is aggravated by a considerable contribution of
waterborne items from shipping activities.
The problems of hazardous waste management are under study. Re-
ceiving facilities for hazardous wastes are being planned on a
nationwide basis for solvents, pesticides, waste oil, etc.
Norway participates in a Nordic waste exchange set up to put
wastes to beneficial use in industry, which again reduces con-
tamination from deposited waste. A nationwide system of
depositories for heavy metal wastes from industrial metal fin-
ishing operations is being set up.
There are not many examples of mandatory product control measures
aimed at preventing health or environmental hazards by waste or
litter. A tax of about $.13 per can was imposed on non-return-
able metal beverage cans in 1974. The tax has significantly
limited the use of such cans. Plastic shopping bags provided
by merchants free of charge on purchase of consumer products
have become increasingly conspicuous littering items over the
years. In an attempt to reduce proliferation of the plastic
bags, a charge of about $.045 was imposed for each bag. For
various reasons the measure has not been completely successful.
The state monopoly of wines and liquors buys its own bottles
back at about $.075 each (the percentage of returned bottles
around 70) and takes foreign bottles back at no compensation.
Breweries and soft drink producers charge deposits of $.06 and
$.11 per bottle depending on bottle size, and the rate of
return of beer bottles is about 98.5%.
One example of likely product control action to be taken under
the product control law concerns polychlorinated bicenyls (PCB).
Measures will be introduced to limit the use of PCBs and ensure
safe disposal of the product itself and of products containing
PCBs (such as electrical components).
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5.4 Discussion
5.4.1 Legislation
The federal restrictions on air and water pollution limit the
discharge of substances and dumping of wastes into water, and
the emission of substances into air. The pollution abatement
facilities produce increasing quantities of residues from air
and water purification processes, creating new pressures on
waste disposal. Many bills have been introduced over the
past few years to enable the federal government to better
cope with this situation. The present federal laws relating
to wastes confer little regulatory authority, are not partic-
ularly directed at product control, and have virtually no
effect in reducing hazards to health or the environment from
products.
Enactment of the present laws seems to have been somewhat half-
hearted up to about 1974, but efforts have since increased. The
present acts are generally regarded as transitional, in antici-
pation of new legislation.
In Norway, the government has had little authority to regulate
products that cause waste problems, but the new product control
law is considered to be adequate to protect health and the
environment from such products. The law does not call for the
use of fees or taxes, although waste control may be one area
where such tools could be useful. However, Parliament can
prescribe such measures where necessary.
The first draft of the product control bill included a paragraph
authorizing control of products which contribute to unreasonable
use of energy and material resources. However, it was felt that
such controls must be supported by thorough analysis of the re-
source situation and be based on adopted plans for resource
utilization. The provision was defered until such a basis can
be developed.
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5.4.2 Approaches and Actions
Apart from a number of studies conducted by EPA, no significant
actions to control products that create wastes have taken place
at the U.S. federal level. Considering the severe problems
with hazardous wastes, it is likely that federal action will
begin in this area. The legislative development in the area
may indicate that measures may be directed more to the urgent
needs for handling, disposal and recycling practices for the
wastes that are created, than to product control actions to
alter design, composition, and other properties of products
in an attempt to reduce wastes or alter the quality of wastes
to make them more environmentally acceptable.
Considerable interest has been shown in Congress for legisla-
tion designed to stimulate conservation and recycling of mate-
rials and energy. (Such measures would in turn have positive
influence on health and environmental effects of wastes). How-
ever, inability to act so far may reflect the political strength
of resource-consuming and waste-generating industries. Little
change can be expected in this area as long as there is no
acute shortage of resources and the market is able to bear the
increasing costs. If any breakthrough were to take place, it
would probably be in reaction to authoritative predictions of
future shortages.
Given more time, Congress could conceivably pass limited legis-
lation to reduce littering by deposit or return schemes and
maybe even standardization of packaging. A few states have
laws on the books which require recycling of beverage contain-
ers and other littering packaging. Considering the apparent
needs, and bearing in mind that many of the products in question
are traded in interstate commerce, a strong federal role should
be justifiable.
In Norway, actions up to now have been largely reactive to
immediate problems. To improve the present situation where
necessary, a broad effort is required to analyze the product
waste situation and identify problem products and suitable
control remedies, an effort that will take some time. Mean-
while, ad hoc solutions will be worked out.
For the longer term it will be important to develop product
design criteria, generic product standards and standardization
schemes to reduce the quantity of wastes, increase re-use and
recycling and improve waste separation and treatment properties
of products. Information to consumers about product waste
hazards and proper disposal is believed to be important, and
information programs and labeling must be developed.
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Fees may be effective in influencing the design and use of prod-
ucts with waste effects (see, for example, section 5.3.3 on
taxation of non-returnable metal beverage cans), but must be
studied further to become a truly useful regulatory tool. Local
solid waste handling may be entirely user-financed by taxation
of products that create unnecessary waste. Such taxation would
also contribute to source reduction, and would be in conformance
with the polluter pays principle.
The clause concerning responsibility for anyone who handles a
product to take reasonable precautions to avoid health damage,
pollution or waste, and the obligation to acquire such knowl-
edge as is necessary to determine whether such effects may
arise, applies also to products causing litter and waste.
Guidelines will probably have to be written to indicate what
the responsibilities are, and how precautions may be taken.
It will be possible to require that the producers or importers
undertake studies of the waste or littering impacts of their
products.
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6.0 OTHER TYPES OF HAZARDOUS PRODUCTS
6.1 The Problem in General
This chapter concerns a broad range of products which may
give rise to hazards by radiation, inaudible sound, light,
heat, etc., or by virture of electrical, explosive, flammable
or mechanical properties.
While all such products and their hazardous effects are
important in their own right, a detailed treatment of these
problems largely falls outside the scope of this report,
i.a. because their environmental significance may be relatively
limited. However, a brief presentation of laws and the product
control situation may be warranted by the fact that some of
these products also have properties of environmental signif-
icance. For example, a chemical substance may cause both radia-
tion and chemical effects. Or a product could conceivably
combine such undesirable properties as electric hazard, fire
hazard, heac hazard and excessive noise. Also, the effects of
exposure to a product emitting radiation may be additively re-
lated to environmental radiation effects. Another reason for
including some words on the topic of "other effects" is the
fact that many laws, including the new Norwegian product con-
trol law, concern such products as well as those that are more
environmentally significant. Also, a brief mention of control
of "other effects" products will shed some light on the extent
of government involvement in product control in general, and
give an impression of the scope of environmental product con-
trol in the total framework.
X-rays are hazardous to health, and as use of x-rays both for
medical and industrial purposes tends to increase, they are
cause for growing concern. Following the rapid development
of electronic products for research as well as occupational
and consumer use, other types of radiation have become increas-
ingly important health hazards. Ionizing radiation (which
includes x-rays) may also be emitted from television receivers
and electron microscopes. Non-ionizing electro-magnetic radia-
tion is emitted from products such as sunlamps and welding
equipment (ultra violet), alarm systems, ovens and heaters
(infrared), alarm systems, ovens and heaters and radar devices
(microwave). Knowledge of possible harmful effects of radio
low-frequency radiation is generally not well developed, and
effects of such products as signal generators and power genera-
tion and transmission equipment are under study. New applica-
tions of laser radiation in products such as cutting and weld-
ing devices and communication equipment call for certain safety
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precautions. Products such as vibrators (infrasonic), sound
amplification equipment (sonic) and cell and tissue disinter-
graters, cleaners and testing equipment (ultra sonic) also
present hazards of various kinds.
Explosives have been subject to control for a long time, and
controls are, of course, needed at all steps from production
through transportation, storage and use. Relatively new types
of consumer products may be prone to explosion (such as spray
cans) or implosion (TV tubes). Also, there is a number of
chemical substances as well as consumer and building products
that may be dangerous because of their flammability properties
or because they give off harmful combustion products. Electric
fixtures and appliances are responsible for a significant number
of injuries due to electrocution and fire hazard.
Finally, there is a vast number of products in the transportation,
occupational and consumer sectors that cause a great number of
physical injuries each year, as evidenced by accident statistics
compiled by the Occupational Safety and Health Administration
and the Consumer Products Safety Commission. Some products are
inherently hazardous (e.g. power tools), and efforts should be
directed at making them safer to use. Some products are unin-
tentionally hazardous (e.g. poorly shielded radiation devices;
or bicycles with inadequate brakes), and much of such hazard
can be avoided once it is identified. There are also products
which purportedly give protection from hazard (e.g. life vests,
gonad shields or earbells), and performance failures of such
products must be avoided. In some cases, products are sub-
ject to uses or treatment for which the product was not intended.
Such uses may be either intentional or unintentional, and in
some cases it may be necessary to modify or restrict such products.
It is possibly true that most of the damage atributed to these
kinds of products are caused by negligence, imprudent or unin-
formed use. However, there is great opportunity for reducing
damage by making products safer.
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6.2 U.S.A.
6.2.1 Major Legislation
The Consumer Product Safety Act of j-972 provides a number of
options for regulation of consumer" products (see section 3.2.1).
The Act is used when the Poison Prevention Packaging Act or the
two following acts are not applicable.
The Federal Hazardous Substances Act of 1960 (see section 3.2.1)
isusei to regulate a great number of consumer products for
safety from i.a. electrical or mechanical hazard.
The Flammable Fabrics Act of 1967^ authorized CPSC to set flamma-
bility standards, to seize or confiscate products which are not
in compliance, and to inspect, test, analyze, etc. Standards
apply to imported products, but not to exports.
The Occupational Safety and Health Act of 1970 (see section 3.2.1)
isused to set requirements as to safety ofproducts used in the
workplace, such as performance requirements, handling and label-
ing.
The Transporation Safety Actof 1974 (see section 3.2.1) is used
to control handling, packaging,labeling, etc. of products. The
Act also has provisions concerning transportation of radioactive
materials. There is a separate act relating to transportation
of explosives.
The Radiation Control for^ Health^and Safety Act of 1968 is used
to regulate radiation,sound, light, etc", fr6m"~*aTi"" types of
electronic products. Regulations take the form of product per-
formance standards and there are certification requirements for
products for which standards are applicable. Manufacturers or
importers must report any radiation hazard not in compliance
with standards, and must alter or replace inadequate products
without cost or make a refund for the cost of the product. Im-
ports are subject to the same rules as domestic products, and
products must carry labels warning of hazards and proof that they
comply with standards.
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6.2.2 The Product Control Situation
Control of radiation products in the U.S. is the responsibility
of the Food and Drug Administration's Bureau of Radiological
Health, which covers both professional and consumer products.
Standards for product performance, safety features and labeling
exist for diagnostic x-ray equipment and cabinet x-ray machines
such as those used in industries, museums, laboratories etc.
for various quality control and research applications and for
inspecting luggage at airports. Standards are proposed for laser
equipment, microwave ovens, ultrasound and photo therapy equip-
ment and sunlamps.
X-rays used for diagnostic purposes account for 90% of all
exposure to man-made radiation, and it is the major aim of the
program to minimize the exposure by regulating machine perform-
ance and to work for safer operators' performance. However,
there is no regulation limiting the total exposure each patient
or operator may be subjected to over time.
Transportation of radioactive materials is regulated by the
Department of Transportation, the FAA, the Postal Service and
the Coast Guard through restrictions, handling and packaging
requirements.
While authority exists for regulating electrical products, no
Federal regulations exist. A regulation concerning extension
cords is under preparation by the Consumer Product Safety
Commission (CPSC).
Certain explosives and flammable substances and contents of
pressurized containers are under regulation by CPSC. The Com-
mission also regulates flammable childrens1 sleep ware.
A wide selection of consumer products which give rise to various
physical hazards are regulated by CPSC. Most of the regulations
concern performance or design features and labeling. Federal
control of consumer products is a new effort (CPSC became opera-
tional in 1973). It may be too early to assess the impact of
the work, but promising advances have been made. The fact that
the agency has wide-ranging authority to attack the issues in a
methodical way, probably places the U.S. in a uniquely advanced
position among countries. (Similar efforts are being planned
i.e. in Britain and Scandinavia).
There are also control systems for motor vehicles, aircraft,
boats, and products used in the workplace, all regulated by
different agencies.
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6. 3 Norway
6.3.1 Major Legislation
K«' ferrnce is rondo to Law on wot Ker J.H <>i FMM j mi of I '}r»(i (sr>r>
section 3.3.1). ~~~~~
Law concerning flammable goods of 1971 concerns handling, trans-
portation, storage and sale of flammable goods.
Law concerning explosives of 1974 provides authority to regulate
use, storage, trade and other handling of explosives.
The Fire Act of 1970 covers prototype approval of extinguishing
equipment and heaters using flammable fuels.
On radiation and electrical equipment there is a law concerning
use of x-rays and radium of 1938 and law concerning control of
electrical systems of 1929.
The law concerning product control of June 11, 1976 will give
a basis for control, of any type of product and thereby fill
some rather serious gaps in existing legislation. To the
largest practical extent, control of various product groups
will continue under the applicable special legislation, and
the new law will be used beyond this when necessary.
6.3.2 The Product Control Situation
Statistical or other information concerning injury and death
related to products are presently not developed sufficiently
to permit a quantitative assessment of product hazards. Occupa-
tional statistics indicates that there were 6,000 injuries
involving various types of machinery and hand tools in 1973.
A report on flammable textiles from 1974, estimates that 50
persons die and 1-200 persons are injured per year in cases
where clothing has been ignited. Work is now under way to
study systems for injury information and to develop strategies
for prevention of accidents in the home.
Control activities relating to explosives, flammable substances
and radiation have been undertaken. All electrical components
are subject to prototype testing and pre-market approval. There
are also control systems for transportation of goods, for motor
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LITERATURE—a selection
1. The Fifth and Sixth Annual Reports of the Council of
Environmental Quality, December 1974 and December 1975.
2. Federal Environmental Law, Environmental Law Institute, 1974.
3. Environmental. Protection Agency (EPA) : Justification of
Appropriation Estimates for Committee on Appropriations,
Fiscal Year 1977.
4. EPA: Legislation, Programs and Organization.
5. International Economic Report of the President to Congress,
March 1975, Chapter 1 — International Environmental Practices.
6. The Federal Register. Various Standards and Regulations.
7. Norwegian Bill on Law Concerning Product Control
(Ot.prp.nr.51 (1974-75)).
8. Organization for Economic Cooperation and Development
(OECD) ENV (75) 12 Scale 2 — Comparative Review of Management
Options with Respect to the Implementation of Environmental Policy.
9. OECD — Addendum to Annex to NR/ENV/7546. Regulations
Relating to Environmental Chemicals — Pre-market and Post
Market Controls.
10. Decision Making for Regulating Chemicals in the Environment.
National Academy of Sciences 1975.
11. Principles for Evaluating Chemicals in the Environment.
National Academy of Sciences 1975.
12. R. Train: New Dimensions to Pesticide Policy Making.
Remarks before a Meeting of the Chemical Specialties Manufacturers
Associates, December 8, 1975.
13. J. R. Quarles: Statement on the Implementation of the
Federal Insecticide, Fungicide and Rodenticide Act to Committee
on Agriculture, May 12, 1975.
14. "An Approach to the Control of Toxic Substances",
November 12, 1973. Internal Draft Document, EPA Office of
Toxic Substances.
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15. Strategy of the EPA for Controlling the Adverse Effects
of Pesticides, May 1974.
16. Air Program Policy Statement/ First Edition, EPA, August 1974.
17. Water Quality Strategy Paper, Third Edition, EPA, August 1975.
18. Draft National Safe Drinking Water Strategy, EPA, May 1975
19. Earth, Steigerwald: Relating Emissions from Motor Vehicles
to Air Quality, Statement before Senate Committee on Public
Works, May 13, 1975.
20. Bill H.R. 10318 on the Toxic Substances Control Act,
October 22, 1975.
21. Consumer Product Safety Commission (CPSC) Annual Report 1975.
22. The President's Report on Occupational Safety and Health,
December 1973.
23. M. Corn: Statement for House Appropriations Subcommittee,
1977 Budget Request for Occupational Safety and Health Administra-
tion.
24. Information on Levels of Environmental Noise Requisite to
Protect Public Health and Welfare with an Adequate Margin of
Safety, EPA, March 1974.
25. Decision Process in the Development of Noise Regulations
in the U.S., U.S. Working Paper for Ad Hoc Group on Noise
Abatement Policies, OECD, January 8, 1976.
26. Draft EPA Noise Abatement Program Strategy, 1975 (unofficial).
27. Consumer Product Noise: A Basis for Regulation.Consumer
Product Safety Commission, November 1974.
28. Incentives for Recycling and Reuse of Plastics, EPA, 1973.
29. Report to Congress — Disposal of Hazardous Wastes, EPA, 1974.
30. Skinner (EPA): Reduce the Incentive to Waste. Paper
Presented to Am. Institute of Chemical Engineers, 1975.
31. Third Report to Congress — Resource Recovery and Waste
Reduction, EPA, 1975.
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32. Draft Solid Waste Management Strategy, EPA, October 31, 1974.
t (
33. Bill for Solid Waste Utilization Act.Subcommittee on
Transportation and Commerce, December 8, 1975.
34. Bill S. 1744 for Resource Recycling and Conservation Act, *
May 14, 1975.
<
35. Regulations for the Administration and Enforcement of the
Radiation Control for Health and Safety Act of 1968, July 1974.
36. Progress in Radiation Protection, Food and Drug Administration,
Bureau of Radiological Health 1974.
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