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This is to certify that the

thesis entitled

The Evolution of Federal Pesticide Regulatory
Policy Involving Public Participation

 

 

presented by

Eileen Renee Choffnes

has been accepted towards fulfillment
of the requirements for

MS. degree inBesouLCLLDevelopment

AA
'

Z, “imam/Z:
/ m/

ajor professor

Date 2L May 1982

0-7639

 

 

MSU

LIBRARIES

 

 

 

RETURNING MATERIALS:
Place in book drop to
remove this checkout from
your record. FINES will
be charged if book is
returned after the date
stamped below.

 

 

 

@ Copyright by

Eileen Renee Choffnes

1982

THE EVOLUTION OF FEDERAL PESTICIDE
REGULATORY POLICY INVOLVING PUBLIC PARTICIPATION

By

Eileen Renee Choffnes

A Thesis

Submitted to
Michigan State University
In partial fulfillment of the requirements

for the degree of

MASTER OF SCIENCE

Department of Resource Development

1982

I l-./

ABSTRACT

The Evolution of Federal Pesticide Regulatory Policy
Involving_Public Participation

 

by
Eileen R. Choffnes

An active area for public participation and environmental
litigation over the last 12-14 years has been, and continues to be, the
regulation of pesticides by the EPA. Public interest/advocacy
organizations have played a significant part in the political decisions
to regulate problem pesticides. Through the use of adversarial
procedures they have shed light on the value judgments and political
trade-offs inherent in these controversies.

On Thursday, August 7, 1980, the U.S. EPA published a rulemaking
proposal which would have significantly amended the procedures used for
conducting adjudicatory hearings under section 6 of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA). Through the
statements advanced in this pr0posed rulemaking the EPA sought to
achieve an administrative resolution to what is fundamentally a
polycentric controversy by infusing a wanagerial decisionmaking model
into the realm of public policy formulation.

This study was undertaken to explore the institutional framework
inithin which pesticide policy is made. During the course of this

investigation it became clear that the proposed rulemaking discussed

herein was of questionable legality from the standpoint of the statutory
language of FIFRA and the case precedents. It was haped that this
analysis would influence the EPA's regulatory interpretation of its
affirmative duties under FIFRA.

On July 22, 1981, the EPA withdrew the rulemaking pr0posal which is
the subject of this study. It is unclear whether the Agency will
repropose this rule at some future data, but this study demonstrates
some of the problems involved with public participation in pesticide

decisionmaking.

TABLE OF CONTENTS

IntrOdUCt1on O O 0 O O O O O O O O O O O O O O O O O O O O O O 0
References . . . . . . . . . . . . . . . . . . . . . . ..

 

 

 

 

Chapter 1: History_of Pest Control ...............
References. 1 . . . . . ..... . . . . . . . . . . . . .
Chapter 2: History of Pesticide Legislation . . . . . .
Rebuttable Presumption Against Reg1stration/Reregistration.
References. ...... . . . . . . . . . . . . . . . . . .
Chapter 3: Public Participation in Trans-Scientific
Decisionmaking at EPA ...... . . . . . . . ......
ToxicOTogical Testing ....... . . . . . . . .....
Acute Toxicity . ........... . .......
Chronic Toxicity ...................
Epidemiological Studies. . . . . . . . . .......
Species-to-Species Correlation ............
Theory and Practice of Carcinogenesis Bioassays. . . .
DDT ......... . ..... . ............
Aldrin/Dieldrin ......... . . . . . . . . . . . . .
Chlordane/Heptachlor ....................
References. ...... . . . . . . . . . . . . ......

Chapter 4: A Critiqge of the Proposed Amendments to EPA's
Current Rules of Practice Governing Pesticide Hearings.
l2 Proposed Rules ...... . . . . . . . . .

A. Merging of the RPAR Process with the FIFRA §
6 Hearing Procedures. . . . . . . . . . . . . . . .
B. The Screening Tests . . . . . . . . .......
C. Modifications of the Rights of Public
Participation Standing. . . . . . . . . . . . . . .
ll. The Right to a Formal Adiudicatory Hearing
Guaranteed By FIFRA and theiAPA Nould“Bé’
Abridged By the Proposed Rules. . . . . . . . .....
lll. The Need for Public Participation in Pesticide
Regulatory Decisions. . ................
References. . . ..... . . . . . . ...........

 

 

cone] "Sioq O ’ O ...... O O O 0 O O O O O O O .......
Referencgs O O O 0 O O O O O O O O O O O O O O O O O O O O 0

Appendix I O O O O O O O O O I O O O O O O O O O O O I O O O O 0

ii

Page

INTRODUCTION

The rise of administrative bodies probably has been the most
significant legal trend of the last century and perhaps more
values today are affected by their decisions than by those
of all the courts, review of administrative decisions apart.
They also have begun to have important consequences on
personal rights. . . They have become a veritable fourth
branch of government, which has deranged our three-branch
legal theories much as the concept of a fourth dimension
unsettles our three-dimensional thinking.

 

Courts have differed in assigning a place to these seemingly

necessary bodies in our constitutional system.

Administrative agencies have been called quasi -legislative.

quasi-executive or quasi-judicial, as the occasion required,

in order to validate their functions within the

separation-of-powers scheme of the Constitution. The mere

retreat to the qualifying “quasi" is implicit with

confession that all recognized classifications have broken

down, and "quasi" is a smooth cover which we draw over our

confusion as we might use a counterpane to conceal a

disordered bed.1

Since World War II, pesticide production and use has increased
enormously. "The United States uses about 1 billion pounds of
pesticides annually to control insects, diseases, rodents, weeds,
bacteria and other pests that attack our food and fiber supplies and
threaten our health and welfare."2 The pesticide industry is thus very
big business indeed ”with current annual sales in the region of $4
' billion."3 While the use of pesticides has unquestionably contributed
to the health, welfare and comfort of man's material needs, they are a
'.lxed blessing.4 They represent one of the most important classes of
general environmental pollutants and their use results in massive.
involuntary human and environmental exposure and contamination.

with the publication of the book Silent Spring. in 1962, Rachel

Carson focussed public attention on the problems created by the
1

2

injudicious and indiscriminate use of pesticides. Carson summarized her
position as follows:

It is not my contention that [pesticides] must never be

used. I do contend that we have put poisonous and

biologically potent chemicals indiscriminately into the

hands of persons largely or wholly ignorant of their

potentials for harm. We have subjected enormous numbers of

peOple to contact with these poisons, without their consent

and often without their knowledge. If the Bill of Rights

contains no guarantee that a citizen shall be secure against

lethal poisons distributed either by private individuals or

by public officials, it is surely only because our

forefathers, deSpite their considerable wisdom and

foresight, could conceive of no such problem.

...(Flurthermore,...we have allowed these chemicals to be

used with little or no advance investigation of their effect

on soil, water, wildlife, and man himself. Future

generations are unlikely to condone our lack of prudent

concern for the natural world that supports life.6

Former President Nixon, in late 19707, transferred principal
authority for the regulation of pesticides from the United States
Department of Agriculture (USDA) to the newly created Environmental
Protection Agency (EPA). Earlier that year the USDA had been
criticized, by Congress, in its traditional handling of pesticide
regulation. Its activities in the area of pesticide safety were called
“scandalously derelict“3, in part because "farm groups, food producers,
and the manufacturers of agricultural chemicals [were] strongly
represented in USDA..."9 By contrast the EPA, it was assumed, given its
presidential mandate to "ensure the protection. . .and enhancement of
the total environment"10 would not be so biased towards the interests of
those whose activities it sought to regulate.
An active area for public participation and environmental

litigation over the last 12-14 years has been and continues to be the
regulation of pesticides by the EPA. Perhaps the most controversial

litigation was the first (successful) action by a public interest

organization to "ban" DDT. Starting in 1966, in Long Island, New York
and terminating seven years later in the U.S. Court of Appeals for the
District of Columbia, the DDT case, brought by the Environmental Defense
Fund (EDF), established many important legal precedents including the
standing of citizens groups to sue government agencies, as well as
judicial review of government agency actions and inactions.

On Thursday, August 7, 1980,11 the U.S. EPA published a pr0posed
rulemaking in the Federal Register which would significantly amend the
procedures currently used for conducting adjudicatory hearings under
Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). In the preamble to the proposed rulemaking, the EPA stated
that, "(tlhe objective of [this] proposal is to make the Agency's
procedures for identifying and assessing potential problem pesticides,
and making regulatory decisions. . .more Open, responsive and efficient.
The fundamental theme...is to create (a)...system in
which...adjudicatory .hearings are utilized...to probe and challenge
decisions reached..."12 While the Agency claimed that “these changes
[were] designed to enhance public participation in the process"13 in
fact the ultimate effect of these proposed rules would have been to make
public participation a hollow exercise in the formulation of pesticide
regulatory policy "with the Agency internalizing most if not all of the
critical value judgments involved.“14

Through the pr0posals put forward in this pr0posed rulemaking the
Agency sought to achieve an administrative resolution to what is really
a polycentric controversy by infusing a managerial decision making model

_into the realm of public policy formulation.

4

The regulation of pesticides, like the regulation of other
toxic/harmful substances, is fundamentally a trans-scientific process.
In an ideal world one would like to have complete knowledge on the
beneficial and non-beneficial outcomes derived from the use or non-use
of a particular pesticidal agent before making a regulatory decision.
Yet often the information available to a decisionmaker is, at best,
incomplete or speculative. "Lacking scientific evidence the agencies
are stuck with visceral estimates and political accomodations as the
only basis for policy."15 Thus, any policy decision requires a
balancing between the scientific "facts," on the one hand, and the value
biases of the decision-maker on the other.

Certain analytical techniques, among them cost-benefit analysis,
risk-benefit analysis, and risk-risk analysis, have been employed by
various regulatory agencies in an attempt to "logically“ and
“rationally“ regulate potentially biohazardous agents. Cost-benefit
analysis "refers to the systematic analysis and evaluation of
alternative courses of action drawing upon the analytical tools and
insights provided by economics and decision theory. It is a framework
and a set of procedures to help organize the available information,
display trade-offs, and point out uncertainties."16 Risk-benefit
analysis is a somewhat vague process which requires one to weigh the
risks of a given activity against its social benefit(s). iflfll
quantification and valuation under the risk-benefit framework is left to
the expertise of the decision-maker.17 The risk-risk framework "allows
beneficial health effects to be considered along with adverse health

effects."18

5

Although not formally required to under FIFRA, EPA has utilized a
cost-benefit approach in its regulation of problem pesticides. While
this approach provides a logical and systematic format for a
decision-maker to follow in reaching a decision it has certain
limitations:

The most important and pervasive limitation on benefit-cost

analysis is the role of values. Many of the factors that

are likely to be most significant in a decision concerning

toxic chemicals cannot be measured in comon terms (such as

dollars) that are agreeable to all concerned parties.

Different individuals place different values on things...

Thus, an analysis that assigns a quantitative value to one

or more of these factors is necessarily subjective and, to

some degree, arbitrary.19

Even larger problems are created by the distribution of benefits
and costs over time. The value of future costs, in traditioal
benefit-cost analysis, is reduced by the use of a discount rate. This
discounting technique has often been used by regulators to minimize the
intergenerational effects of chronic exposures to toxic substances.20
For, where there exist,

. . .complex problems involving large numbers of interested

parties the concept of a single best solution is misleading.

Quantitative techniques of decision making are of great

value in solving many problems; however, they offer little

prospect of serving as an impartial, irrefutable arbiter of

the conflicts of interest involved in large policy

problems.21

This study was undertaken to explore the. institutional framework
within which pesticide policy is made. During the course of this
investigation it became clear that the pr0posed rulemaking dicussed
herein was of questionable legality--both from the standpoint of the
statutory authority of FIFRA and legal precedent. It was hoped that
this analysis would influence the EPA's regulatory interpretation of its

affirmative duties under FIFRA. On July 22, 1981, the EPA withdrew the

rulemaking proposal which is the subject of this study. It is unclear
whether the Agency will reprOpose this rulemaking at some future date.
The discussion of pesticide regulation and the role of the public
in the formulation of pesticide regulatory policy will consist of three
parts. Part I will be concerned with the history of pest control and
the evolution of pesticide laws in the United States. The second part
relates to the regulatory framework used by EPA in implementing the
Congressional mandates of the FIFRA. Finally, the role of public
interest organizations in the formulation of pesticide regulatory policy
will be narrowly discussed in terms of environmental litigation used to
catalyze agency action and more broadly in terms of equity‘

considerations and distributive justice.

10.

11.

12.

REFERENCES

343 U.S. 487-88.

"Delays and Unresolved Issues Plague New Pesticide Protection
Programs", Report by the Comptroller General of the United
States, U.S. General Accounting Office, 8-196815, CED-80-32.
February 15, 1980, p.1.

Epstein, Samuel S. (M.D.): The Politics of Cancer, Sierra Club
Books, (1978). p. 246.

 

Dr. David Pimentel, of Cornell University, maintains that total
insect damage to crops has doubled since synthetic organic
pesticides were introduced into American agriculture after the
end of World War II. This is due, in part, to monoculture
agricultural practices and the increasing resistance of insects
to insecticides. We are still losing one-third of our crop
yields to pests and, while losses due to weed pests have
remained stable or declined, the losses due to insect pests
continue to escalate. For further discussion see: Pimentel,
David, et. al.: "Benefits and Costs of Pestich'E Use in U.S.
Food Production“, Bioscience, 28(12):772: Zwerdling, Daniel:
“Curbing the Chemical Fix: Organic Farming: The Secret is it
Works", The Prggressive, 42:(12):16; Smith, Ray: ”History and
Complexity 0f Integrated Pest Management" , in Pest Control
Strategies, eds., Pimentel and Glass, Academic Press, New York,

 

 

 

R. Carson, Silent Spring(Boston: Houghton-Mifflin, 1962).

 

Ibid., p. 22.

Reorganization Plan No. 3 of 1970, 84 Stat. 2086, reprinted in
Appendix to 5 U.S.C. at 611 (1970). -

 

Rodgers, William H., Jr. "The Persistent Problem of the
Persistent Pesticides: A Lesson in Environmental Law," 70
Columbia Law Review 567, 571 (1970).

 

Ibid. , at 570.

Message of the President Accompanying Reorganization Plan No. 3
of 1970, supra, note 6.

Federal Register, Vol. 45 No. 154, Thursday, August 7, 1980, p.
52627.

Ibid. , p. 52628.

13.
14.

15.

16.

17.
18.
19.
20.
21.

Ibid., p. 52628.

EDF Comments on OPP-60004: "Proposed Rules Governing Rebuttable
Presumption Against Registration Proceedings; Preposed Rules of
Practice Governing Hearings Under Section 6 of the Federal
Insecticide, Fungicide, and Rodenticide Act. December 22, 1980.

Lave, Lester 8.: The Strategy of Social Regulation: Decision

Framework For PoliCé, The Brookings InstTtution, Washington,
a o e at , an 20-380

Decision Making for RegulatirLLChemicals in the Environment,
National Academy oTSciences, Washington, D.C., (1975), at
Chapter 6.

Supra, note 15.
2911-.
Supra, note 16.
11211:.

Bauer, "The Study of Policy Formation: An Introduction," in R.
Bauer and K. Gergen, The Study of Policy Formation 1, 9 (1968).

CHAPTER 1

History of Pest Control

 

The evidence is abundant that with the single strategy of
chemical control we not only have saturated the environment
\Nlth deadly poisons that endanger a wide spectrum of living
organisms, including man himself, but that we have begun to
disrupt seriously the economic stability of the farming
community, with disaster approaching if we follow our
present course.

The definition of a "pest" is wholly anthropocentric. In general a
pest is any organism which reduces the availability, quality, or value
of some human resource. The resource may be a plant or animal grown for
food, fiber or pleasure. The resource may also be a person's health,
well-being or peace of mind--any or all of which may be threatened from
time to time by allergy-inducing or otherwise bothersome plants,
<Hsease-vectoring organisms, or biting, stinging and nuisance-type
animals.2 Therefore, any insect, weed, fungus, bacteria, rodent, virus,
bird, etc.,vufich competes with man's agricultural or domestic
activities can be classified at any time as a pest. Once an organiSm
has been identified as a "pest" every effort is employed to control or
eradicate its depredation of man's resources. Often these control
strategies bear a striking resemblance to "seek and destroy" missions.

For thousands of years, man could do nothing about pests but appeal
to the power of magic and a variety of gods. Early humans, for the most
part, had to live with and tolerate the ravages of insects and plant

diseases. Through "trial and error" experiments, they gradually learned

how to improve their lot.

10

Before 2500 B.C., the Sumerians had learned to use sulfur as an
insecticide. The ancient Chinese used arsenic and mercury compounds,
and the Romans used arsenic, to kill insects.3 In the 19th century
pesticide use expanded dramatically with the discovery of the
insecticidal and fungicidal prOperties of Paris Green (capper
aceto-arsenite) and with the finding that Bordeaux mixture (hydrated
lime and copper sulfate) prevented powdery mflldew infestation of grapes.

Before 1900, the aim of pest control was to exterminate the

pest by any means short of destroying the crap. For

example, lead arsenate was used in large quantities for

insect control, and it was common to observe fruits and
vegetables for sale that were "powder white? with residues.4

[unfing the 19th and 20th centuries a number of other inorganic
compounds were tried as insecticides and fungicides but were not very
effective. These included compounds of antimony, boron, capper,
fluorine, manganese, mercury, selenium, sulfur, thallium and zinc.
Chemical weed control became possible at the end of the 19th century
when iron sulfate was found to kill broadleafed weeds but not cereal
crops. It was more economical, however, to continue using hand weeding,
tillage, and cr0p rotations with plants that could compete with weeds
for the available sunlight, nutrients, and water, and clean cultivations
to keep weed densities at manageable levels. Herbicides were not widely
used until the second half of the 20th century.5 Insecticide use,
generally, was restricted to certain fruits and "high cash" crops turtil
the mid-1960's.

Some of the early pesticides were recognized as poisons. France
banned the practice of soaking food crap seeds in mercury and arsenic in

1786. Harmful effects other than acute poisoning were known. EurOpean

women often used arsenic-impregnated pastes to whiten their skins in the

11

18th and 19th centuries even though arsenic was long recognized as a
poison. The perSistence of these chemicals also went unnoticed, though
their accumulation sometimes caused crap damage. It is now known that
the inorganic pesticides can remain in soils for up to 40 years, and
many orchard soils contain large amounts of them today.

Synthetic organic chemical pesticides were developed by the U.S.
government during World War II for use against insects that were vectors
for diseases such as malaria and typhus. After the war they became
widely available to farmers who saw in them an end to cr0p losses due to
insects.6

The organochlorine compounds, especially DDT, were apparently
"ideal." They were effective against a wide variety of insect pests at
application rates that were extremely low compared to the amounts that
had a known, imediate effect on humans and domestic livestock. Their
persistence in the soil after use contributed to their popularity since
pesticides belonging to this class did not have to be applied repeatedly
during the growing season.

At first, residual traces of these chemicals found in foods and
occasional fish kills after a body of water had been treated were
generally accepted as mild side effects accompanying the desired insect
control. Concern for the ecological effects of widespread pesticide use
began to grow, however, after various studies demonstrated the almost
universal presence of the organc lorine insecticides in the global
environment. Increasing numbers of wildlife were dying, and the
organochlorines were reaching high concentration in certain mammalian
tissues. Measurable quantities could also be detected in the air, in

stream beds, and even in the polar regions of the Earth.

12

Investigation of the high levels of DDT in animals not directly
exposed to the insecticide led to an appreciation for the phenomenon of
bioaccumulation. Like the chemically related PCBs, DDT is resistant to
degradation. Having a high affinity for lipids it tends to collect in
the fatty tissues of animals, where it can become nuch more concentrated
than it is in the general environment. Predators feeding on animals in
which this concentrating process has occurred--for instance, birds
feeding on insects, worms, or fish--may be exposed to dangerous levels
of the insecticide.

One of the more publicized effects of DDT has been the reduction of
reproductive fitness in many species of birds resulting in declining
bird populations. The organochlorine insecticides have also been
detected in cow and human milk samples. A recent Environmental
Protection Agency study (1978) found traces of organochlorine compounds
in all milk samples tested. In addition, the ability of these
insecticides to collect in animal tissues gives these compounds another
mode of transportation, besides wind and water, to locations where they
were not originally applied.

It was eventually confirmed in the late 1960's, that the
organochlorine insecticides have the ability to induce cancer in
laboratory animals and are, therefore, presumptive human carcinogens.7
Stored in the fatty tissues of the liver, they can cause liver
enlargement and interf re with the liver's ability to detoxify
substances with which it comes in contact.8

The organochlorines also have declining efficacy against insects.
since these organisms have a profound capability of developing physical

and chemical mechanisms to protect themselves against almost any toxic

13

substance challenge. Hal Gordon, of the University of California
(Berkeley)9 observed, in 1961, that those species of insect larvae which
fed on a variety of plants were tolerant to many insecticides. Such
insects were found to possess a multi-purpose enzymatic degradation
system called mixed function oxidases (MFO's). An individual insect may
(under normal circumstahces) have a low MFO level--when the insect comes
in contact with an insecticide its MFO level rises. Thus, an insect
with a high enough MFO level may be able to survive insecticide
challenge and give rise to progeny which are more insecticide resistant.
than the parent generation. In this way, insects have developed a
remarkably inducible system for neutralizing toxic compounds. The usual
response of the grower, when confronted with insect resistance to a
given insecticide, has been to apply greater and greater quantities of
insecticide with little or no additional control achieved in the process
(this situation is the classic example of the "Pesticide Treadmill").
While not eradicating the insect pest, the massive doses of insecticides
have a profound effect upon beneficial organismSuoften eliminating
organisms responsible for plant pollination, soil aeration and waste
degradation. The resultant reduction of beneficial organisms which prey
upon insect pests (killed by insecticides) allows for pest p0pulation
explosions and the emergence of new insect pests, requiring both more
extensive and expensive control measures.10

Concerns about the oncogenic (cancer inducing) effects of the
organochlorine insecticides led to the cancellations of most of their
registered uses. INTI, aldrin/dieldrin, Kepone(R), mirex,
chlordane/heptachlor and endrin can no longer be intensively used in the

U.S. Their papularity, at the time regulatory actions were taken

14
against them, was declining anyway due to the resistance of numerous
insect complexes to them.

To meet the challenge presented by insect resistance to and the
persistance of organochlorines, the agri-chemical industry began to
exploit other classes of insecticidal compounds--the organOphosphates
and the carbamates. These compounds are considered "soft" chemicals;
they contain chemical groups which readily decompose under a variety of
environmental conditions.

However, these compounds are acutely toxic to humans, attacking the
nervous system of those exposed. Thousands of pepple are sickened and
many die each year as a result of poisoning caused by contact with
them.11

Some insects have also develOped resistance to these insecticides
as well, although resistance is not as wide-spread as it is to the
organochlorines.

(D)espite the dramatic increases in chemical pesticides
during the past 30(+) years, average annual crop losses due
to combined pest categories (i.e., insects, diseases,
nematodes and weeds) have apparently not decreased; and
there are indications that percentage crap losses attributed
to insect damage have increased as much as two-fold during
this period. There are a number of reasons for this.

. . .(T)here are presently over 300 species of insects,

mites and ticks that posses strains resistant to one or more

chemical pesticides. . . (W)eed control literature is full
of cases in which control is said to be "difficult" because
of decreasing effectiveness of the herbicides, and many

studies have shown the existence of weed strains relatively
resistant to various herbicides.

10.

11.

12.

15

REFERENCES

Nelson, Senator Gaylord: In an address to the Senate upon
introduction of a bill to stimulate research on alternatives to
pesticides; 1971.

Flint, Mary Louise and Robert van den Bosch: A Source Book on
Integrated Pest Management, DHEW publication, 1977.

 

 

Ib1d.

 

Smith, Ray F.: "History and Complexity of Integrated Pest
Management", in Pest Control Strategies, eds. Pimentel and
Glass, Academic Press 1978.

 

Report of the Secretary's Commission on Pesticides and Their
Relationship to GM ronmental Health, Parts I and II, U.S. Dept.
oTlleal th, Education, and Welfare; December, 1969 (hereafter,
Mrak Report) pp. 45, 46.

 

Ibid.
Ibid., at 509 ff.
Pimentel, David: "Socioeconomic and Legal Aspects of Pest

Control" in, Pest Control Strategies, eds. Pimentel and Glass,
Academic Press, N.Y1, 1978.

 

Gordon, H.T.:« "Nutritional Factors in Insect Resistance to
Chemicals," Annual Review of Entomology, 6:27-54, (1961).

 

van den Bosch, Robert, The Pesticide Conspiracy (Anchor Books,
Garden City, New York), 1980, pp. 18-25.

 

"Danger in the Field: The Myth of'Pesticide Safety", a report
prepared by the Florida Rural Legal Services, Inc., May, 1980,
pp. 1-3. see also, "Involuntary Exposure to Agent Orange and
Other Toxic Spraying", Hearings Before the Subcommittee on
Oversight and Investigations of the Comittee on Interstate and
Foreign Commerce, House of Representatives, 96th Congress, lst
Session, 26-27 June 1979, Serial No..96-139.

Muir, Warren 12., Council on Environmental Quality, Executive
Office of the President; Statement during Hearings on Integrated
Pest Management before the Subcommi ttee on Agricultural Research.
and General Legislation of the Committee on Agriculture,
Nutrition, and Forestry, U.S. Senate, 95th Congress, lst
Session, 31 October and 1 November 1977.

CHAPTER 2

History of U.S. Pesticide Legislation

 

The federal regulation of pesticidal products began in 1910, when
Congress passed the Federal Insecticide Act.1 The purpose of this
legislation was twofold: (1) to protect consumers from purchasing
ineffective pesticide products, and (2) to protect consumers from
purchasing pesticide products with deceptive/fradulent labelling
claims._2 Under the Act "[a] product was misbranded if its label was
false and misleading or the package failed to contain the ingredients
listed on the package label."3 While the Insecticide Act of 1910
attempted to regulate the manufacture, sale and transshipment of
pesticide products sold interstate it had no effect upon the intrastate
sale of ineffective products. In as much as registration of pesticide
products sold in interstate commerce was not required there was no
mechanism available for the enforcement of infractions of the statutory
mandates.

The manufacture of pesticides prior to World War II largely
consisted of inorganic products such as calcium arsenate, lead arsenate,
Paris Green, copper sulfate, fluorine compounds and ground sulfur, as
well as, botanical extracts including pyrethrum dusts and extracts,
rotenone dust and nicotine sulfate.4 By the end of World War 11 there
was a virtual "explosion" of activity synthesizing organic chemical
compounds for general sale and use as pesticides. DDT" was being
heralded as a "miracle" insecticide that would be the ultimate solution
to mankind's insect problems. As a result of the rapid expansion of the

pesticide industry and the widespread distribution of these so-called

16

17

"economic poisons" Congress, in 1947, enacted the original Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).5

The FIFRA augmented the Insecticides Act's basic provisions. The
fundamental goal of the legislation was the protection of the general
public from personal and economic injury, taking into account not only
the purchase of products subject to the dictates of the Act but all
persons who might come into direct or indirect contact with pesticides
or materials which could have been treated with them. The statute
provided for the protection of users from unsafe products6 and required
that, before a pesticide product could be distributed and marketed in
interstate commerce, it had to be registered with the United States
Department of Agriculture (USDA). As employed in the Act, the term
"pesticide" has often been substituted for the statute's use of the term
"economic poison" which was defined as:

(1) any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any
insects, rodents, nematodes, fungi, weeds, and other forms

of plant or animal life or viruses, except viruses on or in

living man or other animals, which the Secretary shall

declare to be a pest, and (2) any subtance or mixture of
substances intended for use as a plant regulator, defoliant

or desiccant.

In passing the statute Congress intended to prevent or at least
discourage misleading or false advertising claims, prevent inefficacious
products from being marketed, and provide a legal remedy for the
unsuspecting purchaser if such products were marketed.8 With the
statutory prohibition against ineffective products9 Congress
perpetuated, in FIFRA, the original orientation of the Insecticide Act.

The registration requirement was created as an aid in enforcement.

"Registration [was] viewed as a means of notifying the Secretary of

Agricuture of (1) the products being marketed; (2) their composition;

18

and, (3) the claims made for them."10 FIFRA provided for seizures of
pesticide products in situations where they were adulterated.
misbranded, unregistered or insufficiently labeled, or when such devices
were misbranded.11 Manufacturers requesting registration were given an
opportunity to modify their proposed product label if it failed to
comply with any of the statutory requirements including: (1) the
prominent display of poison warnings, (2) the inclusion of warning
statements on the package label, and, (3) clear and concise instructions
for pr0per product use.12 Yet, even when such label changes were 1193
made by the registration proponent, the USDA was obliged to register the
product "under protest."13 The Secretary of Agriculture was authorized
to cancel a pesticide's registration and substitute in its place a
protest registration "to protect the public"14, yet the statute was
noticeably silent on the precise definition of the standard and what
criteria were to be applied by the Secretary in implementing and
enforcing the Congressional intent of the standard. So far as the Act's
product safety provisions were concerned all that was actually required
was that the product be "safe" (i.e., low acute toxicity) when used
according to the lable directions.15

Congress, in 1959, passed the Nematocide, Plant Regulator,
Defoliant and Desiccant Amendment16 to FIFRA. The 1959 amendments
reflected the additional classes of pesticidal materials which had been
developed and marketed since 1947. Congress felt that these materials
should be subjected to the same registration requirements as those
previously registered under the 1947 FIFRA.

In 1962, Congress modified the regulations to expand the definition

of a "pest." Under the regulations materials used to repel birds,

19

reptiles, predatory animals, certain classes of fish, plant diseases,
and.weeds*were brought under USDA/FIFRA control. As a result
approximately 2,000 more products, produced by approximately 800
establishments, were subject to USDA inspection.17

FIFRA was once again amended by Congress in 1964.18 Under the new
amendments, the Secretary of Agriculture was given the authority to
refuse to register a new product19. thereby eliminating "protest"
registrations. Moreover, the Secretary was given the authority to
remove a pesticide product from interstate commerce if its safety and/or
efficacy was of dubious validity.20 A pesticide was defined as
misbranded if, when used in accordance with the manufacturer's label
directions, it was injurious to human or animal health. The amendments
also authorized the Secretary to suspend a pesticide's registration if
it was found to constitute an "imminent hazard to the public." Be that
as it may, it was not until 5 years later that the Secretary of
Agriculture published the first USDA regulations specifying what
standards were to be applied by USDA in defining an "imminent hazard".21

Pesticide regulation, since 1947, had been plagued with
difficulties almost from its inception. USDA, under FIFRA, was required
by law to register pesticides sold in interstate commerce. However, ii:
could not register a pesticide which left a residue in or on raw
agricultural products unless the Food and Drug Administration (FDA)
under the Federal Food, Drug, and Cosmetics Act (FFDCA) was able to
establish a "safe" tolerance level. If the FDA determined that any
residue was dangerous to human health it could refuse to grant a
tolerance for that particular pesticide use. Without an established
tolerance the USDA was prohibited from registering a pesticide for a

particular use.

20

This "balkanization" of regulatory agency authority over pesticide
registration decisions was, not surprizingly, detrimental to the
efficient formulation of pesticide policy. Often the missions of USDA
and FDA were in direct conflict with one another. Historically, USDA's
mission had "been to promote food production and, therefore, [it]
heavily promoted the use of pesticides. . .(l)ong-term health concerns
were often subordinate to [its] primary goal. FDA, on the other hand,
was charged with safeguarding the public health."22

In order to more effectively and efficiently manage pesticide
regulation President Nixon, in 1970, pr0posed a reorganization of all
federal governmental agencies having authority over pesticides. The
United States Environmental Protection Agency (EPA) was created in
December, 1970.23 Among other things, EPA was given the exclusive
responsiblity of administering and enforcing FIFRA. As the "Kennedy
Report" staff pointed out, though, '

(a)ssigning all pesticide regulation to one agency helped
(to) alleviate bureaucratic overlap and administrative
inefficiency; but. . .did not cure the basic conflict. . .
(M)any of the personnel and much of the philOSOphy from USDA
were simply transferred to the EPA pesticide program in
1970.24

After extensive hearings and under intense lobbying from public
interest organizations, trade associations and the pesticide industry
Congress greatly expanded EPA's pesticide regulatory task with the
enactment of the Federal Environmental Pesticide Control Act (FEPCA) in
1972.25

In addition to requiring the processing of new pesticide
registration applications and pesticide residue tolerance
petitions, FEPCA required that all pesticide products
previously registered over the past 30 years--including some
35,000 federally by USDA and by EPA since 1970, and 15,000

by states--[be] reviewed and subject to a reregistration
process, and classified for either general or restricted

21

use, or both. This task was directed by Congress to be
accomplished by October 21, 1976. The intent of
Congress...was to subject those pesticides approved under
earlier, less stringent safety standards to application of
much improved modern standards. Under FEPCA, Congress
placed on EPA the responsibility to determine whether any of
these pesticides "will perform [their] intended function
without unreasonable adverse effects"26 on human health and
on the environment. If, after an examination of the risks
and benefits, the Administrator...determines that the
pesticide causes "unreasonable adverse effects," h may
restrict, suspend, or cancel the use of the pesticide.2

FEPCA defined "unreasonable adverse effects on the environment" to
mean "any unreasonable risk to man or the environment, taking into
account the economic, social, and environmental costs and benefits of
the use of any pesticide."28 As required by this definition the
balancing of risks and benefits is of particular importance with respect
to four principal types of decisions which the Administrator nust make:
registration, classification, cancellation, and suspension.

APPROVAL OF REGISTRATION - The Administrator shall register

a pesticide if he determines that, when considered with any

restrictions imposed under subsection (d) [classification]--

(A) its composition is such as to warrant the proposed
claims for it;

(8) its labeling and other material required to be submitted
comply with requirements of this Act;

(C) it will perform its intended function without
unreasonable adverse effects on the environment; an

(0) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable
adverse effects on the environment.29

 

CANCELLATION and CHANGE IN CLASSIFICATION - If it appears to
the Administrator that a pesticide or its labeling or other
material required to be submitted does not comply with the
provisions of this subchapter, or when used in accordance
with widespread and commonly recognized practice, generally
causes unreasonable adverse effects on the environment, the
Administrator g§y_issue a natice of his intent either--

22

(1) to cancel registration or change its
classification...or,

(2) to hold a hearing to determine whether or not its
registration should be cancelled or its classification
changed.3

ORDER-~If the Administrator determines that action is
necessary to prevent an imminent hazard during the time
required for cancellation or change in classification
proceedings he may, by order, suspend the registration of
the pesticide iiiliiediately.31

 

The statute then goes on to define an "imminent hazard" as "a situation
which exists when the continued use of a pesticide during the time
required for cancellation proceeding [sic] would be likely to result in
unreasonable effects on the environment or will involve unreasonable
hazard to the survival of a species declared endangered by the Secretary
of the Interior under Public Law 91-135 (the Endangered Species Act)."32

Thus the Adninistrator was given the authority to prohibit the
further sale and use of a pesticide product if he determined that the
product caused "unreasonable adverse effects" on the environment. Upon
the issuance of a notice of intent to cancel33 a registration the
registrant could request a formal adjudicatory hearing on the merits.
Alternatively, the Administrator could issue a notice of his intent to
hold a hearing in order "to determine whether or not [the pesticide's]
registration should be cancelled."34 It is quite clear from the
legislative history of the Act that the purpose behind the inclusion of
this alternative hearing procedure was to allow the Administrator to
"initiate formal review without placing a stigma on the product when 11.
is not convinced that the registration should be cancelled."35

During either type of formal hearing the pesticide may continue to
be produced and marketed. Some of these hearings may take years to

complete. For example,

23

Eighty-six registrants requested a hearing as a result of a

notice of cancellation issued on March 18, 1971, for the

major pesticides aldrin and dieldrin. Shell, sole

manufacturer of these pesticides, played the primary’role in

contesting the cancellation notice. The hearing continued

for twelve months and resulted in a transcript of more than

ten thousand pages in addition to many thousands of pages of

exhibits.35

Should the Administrator discover, after he has issued a notice of
intent to cancel,37 that the continued use of the suspect pesticide will
present an "iminent hazard to the public" during the time required to
complete the cancellation hearings he can issue a notice of intent to
suspend the pesticide's registration. A suspension notice, like a
temporary injunction, has the practical effect of removing suspect
pesticidal products from the marketplace pending the resolution of the
cancellation hearings process. Under this procedure, as with the notice
of intent to cancel, registrants are entitled to a formal adjudicatory
hearing on the narrow question of an imminent hazard. By law this must
be an expedited hearing.38

FEPCA's definition of "imminent hazard" has been interpreted by the

courts to mean a "substantial likelihood that serious harm will be

 

«experienced during the year or two required in any realistic projection
irf the administrative [cancellation] process."39 Moreover, "the
function of the suspension decision is to make a preliminary assessment:
of evidence and probabilities, not an ultimate resolution of conflicting
issues."40

In both types of proceedings, (cancellation and suspennon), the
statute and case law place the "burden of establishing the safety of a
product requisite for compliance with the labeling
requirements...squarely at all times on the applicant and registrant."41

For the Administrator to survive a court challenge to his decision

24

regarding cancellations and suspensions, "(i)t [is] enough...that the
administrative record [contain] respectable scientific authority

supporting the-Administrator."42

Rebuttable Presumption Against Registration/Reregistration

 

On July 3, 1975, the EPA published in the Federal Register”!3
regulations covering the registration, reregistration, and
classification of pesticides mandated by FEPCA. (It nust be kept in
mind that FEPCA was passed in 1972, and Congress mandated that by
October, 1976, approximately 50,000 pesticides which had been previously
registered by USDA on efficacy considerations were to be reevaluated on
the basis of human and environmental health hazards.) The regulations
specified the types of data which registrants were required to supply to
EPA in order for them to retain or receive a product registration“.
They also established criteria for classifying a pesticide for general
or restricted use, and criteria for denying or cancelling registrations
on the basis of acute toxicity. As a practical matter the 1975
regulations were, in reality, a codification of the toxicological
principles established during the DOT, aldrin/dieldrin, and
heptachlor/chlordane cancellation/suspension hearings.

The regulations defined acute toxicity as "the property of a
substance. . .to cause adverse effects in an organism through a single
short-term exposure."45 A pesticide was chronically triic if it,

(A) Induces oncogenic effects in experimental mammalian
species or in man as a result of oral, inhalation or dermal
exposure; or induces mutagenic effects by multitest
evidence.

(8) Produces any other chronic or delayed toxic effect in

test animals at any dosage up to a level, as determined by
the Administrator, which is substantially higher than that

25

to which humans can reasonably be anticipated to be exposed,'
taking into account ample margins of safety; or,

(C) Can reasonably be anticipated to result in significant
local, regional, or national population reductions in
nontarget organisms, or fatality to members of endangered
species.

"Mutagenic" refers to the capacity of a pesticidal compound to induce
genetic changes in the offspring of exposed parents.47

The Administrator, in the preamble to these regulations, stated his
rationale for using animal test data as a predictor for the potential of
a compound to cause adverse health effects in man.

(T)he use of animal test data to evaluate human cancer risks
has been widely accepted by the scientific community and by
public policymaking agencies... (B)ecause of [the] inherent
limitations of animal testing 'a substance that‘will induce
cancer in experimental animals at any dose level, no matter
how high or low, should be treated with great
caution'...(N)egative results are of limited value and
although a no-effect level may theoretically exist, it is
frequently impossible to establish with sufficient
confidence to justify sanctioning widespread exposure.

Moreover, the term "oncogenic" is used in the regulations
because the Administrator (has) determined that the
distinction between "benign" and "malignant" tumors is not
meaningful in determining the hazard of cancer to man on the
basis of tests conducted on a laboratory species, given the
"increasing evidence that many tumors can develop into
cancers." "...(F)or the purpose of carginogenicity testing,
they should be considered synonymous."4
A rebuttable presumption against registration (RPAR) arises when,
after the Agency evaluates information submitted to it by the pr0ponent
of registration, it finds that any one of three criteria, indicative of
unreasonable adverse effects, is met or exceeded: acute toxicity;
chronic toxicity; or lack of emergency treatments in man to ameliorate
P
the toxic effects resulting from a single eXposure. These criteria
represent "indicators of potential hazard";"*9 the pesticide will be

presumed to pose an unreasonable risk once any one of the three criteria

26

is met or exceeded. Once triggered, an applicant is notified of the
presumption against registration and is given an opportunity to submit
rebuttal evidence.50
At all times the ultimate burden of persuasion regarding the safety
of a pesticide lies with the pr0ponent of registration. With respect to
an RPAR, the burden of going forward means,—"the necessity of producing
evidence. . .of a particular fact in issue."‘51 The evidence "nust be
such that a reasonable man could draw from it the inference of the
existence of a particular fact to be proved."52 To successfully rebut a
presumption against registration, the proponent must ultimately prove
that its product does not pose unreasonable adverse effects on the
environment53 or that, in spite of the risks presented by the pesticide,
the benefits of continued use justify its continued registration.54
One writer has observed that,
(t)he decision whether a presumption against registration
has been successfully rebutted is a difficult one. By
raising the presumption the Agency indicates its belief that
there is a high probabiity of significant danger, whereas
the manufacturer's attempted rebuttal is an indication of
its belief that the hazard is less significant than the
initial tests suggest. The decision is thus likely to
require a complex evaluation based upon competing and
perhaps equally tenable, explanations of the data.53
If the proponent of registration produces information of sufficient
weight and validity to rebut the presumption against his product the
Administrator may overturn his original devicinn were this to happen,
the presumption would be said to rebutted. If,
0 \J\
however, a substantial question of safety were still found to exist, the
1975 regulations required the initiation of formal adjudicatory

proceedings under FEPCA.

27

In the fall of 1975, the Administrator of EPA (Train) recommended
procedural modifications to the way the Agency was implementing FIFRA.
The central theme of his memorandum "was to de-emphasize the role of
FIFRA adjudicatory hearings in decisionmaking about problem pesticides.
and institute a system in which the Agency would make pesticide
decisions prior to hearings. ..."55

With regard to cancellation and suspension decisions, I

believe that misconceptions by the public are attributable,

in part, to our reliance on the adversary hearing process to

ensure that all pertinent facts are brought out. While

these procedures have been effective, they have inhibited

full participation by the Office of Pesticide Programs in

the decision process [many of whom came from USDA] and have

restricted effective public involvement in this aspect of

the program. I have determined that the Agency should carry

out a more open evaluation of risks and benefits in advance

of decisions to issue notices of intent to cancel or

suspend.5
Train wrote the memorandum in an apparent response to the proposed 1975
FIFRA amendments contained in H.R. 8841 (later to become P.L. 94-140).

As enacted, the 1975 FIFRA amendments imposed significant
constraints upon EPA's pesticide regulatory authority. Before the
Administrator could issue a public notice of his intent to cancel a
registration, intent to hold a hearing to determine whether a
registration should be cancelled, or change a classification, he had to
first, at least 60 days prior to submitting the notice to the
registrant, submit a copy of the notice to the Secretary of Agriculture
and a newly created Scientific Advisory Panel58 (SAP) for c0111111ent.'59
Both the Secretary of Agriculture and the SAP were given a 30 day
coment period to respond to EPA's pr0posed notice.‘5o After this 30 day
period, the Administrator could publish the notice plus any comments
received from the Secretary and the SAP, including EPA's reply, in the

Federal Register.61 Furthermore, all regulations, both proposed and

28

final, were to be provided to the Secretary of Agriculture, the House
Committee on Agriculture, the Senate Committee on Agriculture and
Forestry and the SAP for comment.62 Finally, the Agency was required to
take into account, in any prOposed action, the impact on production and
prices of agricultural commodities, retail food prices and the
agricultural economy.63

Several provisions of the Federal Pesticide Act of 1978,64 enacted
September 30, 1978, pertain to the RPAR process and the Agency's Rules
of Practice for cancellation hearings. A new section entitled "Interim
Administrative Review", imposed new requirements on the Agency
concerning the quality of information which nust be available to the
Administrator before an RPAR may be issued.

.the Adminstrator may not initiate a public interim
administrative review process to develOp a risk-benefit
evaluation of the ingredients of a pesticide or any of its
uses prior to initiating a formal action to cancel, suspend
or deny registration of such pesticide, . . .unless such
interim administrative process is based on a validated test
or other significant evidence raising prudent concerns of
unreasonable adverse risk to man or to the environment.6

The Conference Report defined "validated test" as. . .a test
conducted and evaluated in a manner consistent with accepted
scientific procedures, and that the term "other significant
evidence" be defined as evidence that relates to the uses of
a pesticide and their adverse risk to man or to.the
environment. It is the intent of the conferees that "other
significant evidence" of adverse risk means factually
significant information and is nog to include evidence based
only on misuse of the pesticide.6

It is also noteworthy that the Conference Report without amending
the statute, addressed rudifications in the RPAR process:

To avoid the time-consuming RPAR process if [in the
Administrator's judgement] humans or their environment are
not at risk or the potential for exposure is minimal, the
Administrtor is directed to forego the RPAR process agd
proceed with the reregistration of the pesticide product.6

29

The guidance of the conferee's, if followed faithfully by the
Agency, will have far-reaching consequences for pesticides which are
presumptive carcinogenic and mutagenic agents. Instead of triggering an
RPAR, the Agency will be compelled to take exposure into account. The
implicit assumption, should this come to pass, is that there exists some
putative threshold exposure level for carcinogenic/mutagenic agents or
that there may be some arbitrary level in the increased rate of cancer
or mutations, (due to exposure to these toxic compounds). that is

"socially acceptable" to the general puplic.

O m ‘4 0‘
o o o o

10.

11.
12.

13.
14.
15.
16.

17.

18.

19.

30

REFERENCES

Act of April 26, 1910, 36 Stat. 331, 7 U.S.C. 121-134. The
original Federal Insecticide Act was entitled, "An Act for
Preventing the Manufacture, Sale or Transportation of
Adulterated or Misbranded Paris Greens, Lead Arsenates and Other
Insecticides and Also Fungicides, and For Regulating Traffic
Therein, and For Other Purposes."

Ibid., §, and generally 1-10.

Ibid., 5.

Arrington, "World Survey of Pest Control Products" 1-2 (1966).
Public Law No. 80-104, 61 Stat. 163 (1947) [codified at 7 U.S.C.
121-135K (1970)]. repealing Act of April 26, 1910, ch. 191, 36
Stat. 331.

Ibid., 5 2(u); 3(a)(5).

7 U.S.C. § 135(a) (1964).

H.R. Rep. No. 313, 80th Cong., lst Sess. 3 (1947).

Ibid.

Supra, note 8, at 3.

7 U.S.Cc 5135(9) (1970).

Public Law No. 80-104, §44c). (e), 61 Stat. 163 (1947).

Ibid., §4(c).

Ibid., §4(c).

Ibid., at§ 2(u) and 3(a)(5).

7 U.S.C. § 135 (1964).

Anderson: "Official Registration of Pesticides" in Scientific
Aspects of Pest Control, 385 (1966).

 

 

Act of May 12, 1964, Public Law No. 88-305, 78 Stat. 190.

Ibid., see 53 [Also, H.R. Rep. No. 1125, 88th Cong., 2nd Sess.,

20.
21.
22.

23.

24.
25.

26.
27.
28.

30.
31.
32.
33.
34.
35.
36.

37.
38.
J9.

40.
41.

31

Ibid., § 3, supra note 18.
34 Fed. Reg. 13,821 (1969).

Staff Report to the Subcommittee on Administrative Practice and
Procedure of the Committee on the Judiciary of the United States
Senate, 94th Congress, 2d. Session, December, 1976 p. 4-5 "The
Environmental Protection Agency and the Regulation of
Pesticides" (hereinafter the Kennedy Report).

Reorganization Plan No. 3 of 1970 (84 Stat. 2086, reprinted in
Appendix to 5 U.S.C. at 609 (1970)).

 

Kennedy Report, supra, note 22 at 5.

Public Law 92-516, 86 Stat. 973 (codified at 7 U.S.C. secs.
121-136).

Public Law 94-410, Nov. 28, 1975, 7 U.S.C.§ 136.

Kennedy Report, supra, note 24 at 5.

7 U.S.C.§ 136(bb).

7 U.S.C.§ 136a(c)(5) (emphasis added).

_1_p_i_g_._,s 136d(b).

1212;,5 136(d)(c). (emphasis added.)

MP 136(1).

M,§136d(b)(1).

1119.115 136d(b)(2).

Senate Report No. 92-838, 92nd Cong., 2d. Sess. 12 (1972).

Reukauf, William: "Regulation of Agricultural Pesticides" 62
Iowa Law Review 909,912 (1977).

 

Supra, note 33.

7 U.S.C., 5 136d(c)(2).

EDF v. EPA, 510 F. 2d. 1292, 1297 (D.C. Cir, 1975 [emphasis in
original]] (mating EDF v. EPA, 465 F. 2d. 528, 540 (D.C. Cir,
1972). .

EDF v. EPA, 465 F. 2d. 528, 537 (D.C. Cir, 1972).

 

 

 

Supra, note 39, and guoting EDF v. EPA, 465 F. 2d 528, 532 (D.C.
Cir., 1972).

 

42.
43.
44.
45.
46.
47.
48.
49.

50.

51.
52.
53.
54.
55.

56.
57.

58.

59.
60.
61.
62.
63.
64.

32

EDF v. EPA, 465 F. 2d. 528, 537 (D.C. Cir., 1972).

 

40 Federal Register 28,242, 28,268 (1975).

 

40 CFR part 162.41-162.47 (1978).

40 CFR part 162.11(a)(3)(1).

40 CFR part 162.11(a)(3)(ii).

40 CFR part 162.3(y).

40 Federal Register 28,242, 28,263 (1975).

Supra, note 48.

40 CFR part 162.11(a)(1).

C. MCCormick, EVIDENCE § 336, (1972).

C. McCormick, EVIDENCE § 338 (1972).

40 CFR part 162.11(4)(iii), 40 CFR part 162.11(4)(ii).
4O CRF part 162.11(5)(iii).

Spector Phillip L.: "Regulation of Pesticides by the

Envig'onmental Protection Agency," 5 Ecology Law Ouarterfly 233,
255 1976 .

 

45 FR 52628, 52630. (1980).

Memorandum from Russell E. Train, Administrator, to Andrew W.
Breidenback, Assistant Administrator for Water and Hazardous
Materials, Robert V. Zener, General Counsel, Alvin L. Alm, April
10, 1975.

P.L. 94-140 SS 7, 89 Stat. 753, amending 7 U.S.C. § 136;
codified at 7 U.S.C. § 136 (1976).

19.12;.» §136(d).
Supra, note 58.
IEIEE.
Supra, note 59.
1219;.

Public Law 95-396, 95th Cong. (S. 1678), 86 Stat. 973-999.
(codified at 7 U.S.C. § 121-136.

65.
66.

67.

33

7 U.S.C. § 136a(8).

Conference Report on the Federal Pesticide Act of 1978 CS. Rep.
No.94-1188, 95th Cong., 2d. Sess., 35(1978)], (emphasis added.)

Ibid., at 36.

CHAPTER 3

PUBLIC PARTICIPATION IN TRANS-SCIENTIFIC PESTICIDE
DECISIONMAKING AT EPA

 

Growing concerns over the pollution of the global environment with
chlorinated hydrocarbon insecticides led Rachel Carson, in 1962, to
focus public attention upon their potential for harm.

...(T)he central problem of our age has therefore become the
contamination of man's total environment with such
substances of incredible potential for harm-~substances that
accumulate in the tissues of plants and animals and even
penetrate the germ cells...to alter the very material of
heredity upon which the shape of the future depends.1

In the years following the publication of Silent Spring2 the public

 

became increasingly critical of the indescriminate use of these
compounds by public agencies and private farmers. As Ms. Carson noted,
"(i)t is the public that is being asked to assume the risks that the
insect controllers calculate. The public must decide whether it wishes
to continue on the present road..."3

no

Since Silent Spring, through actions of public interest

 

organizations like the Environmental Defense Fund (EDF),
non-agricultural interests have played an important role in the
formulation of pesticide policy within the Environmental Protection
Agency (EPA). Often, that role has been one of initiating agency action
when a registered pesticide posed an unreasonable adverse effect on man
or the environment. At other times public interest organizations have
been active participants in pesticide cancellation and suspension

proceedings under FIFRA in support of the Agency's position. The
34

35
cancellations of DDT, aldrin/dieldrin. and chlordane/heptachlor by EPA
were due in large measure to the involvement of public interest;
environmental organizations in these proceedings.

Almost all of the registered uses of DDT
(1,1,1-trichlor0phenylethane) were cancelled on 30 June 1972,4 by then
EPA Administrator William Ruckelshaus. Earlier the Court of Appeals for
the District of Columbia held that cancellation proceedings should be
conmenced whenever a registration of a pesticide raised a "substantial
question of safety"5

Under the pre-1972 FIFRA a pesticide was misbranded,

(i)f the labeling...does not contain directions for use
which are necessary and...adequate for the protection of the
public...5, .

(i)f the label does not contain a warning or caution
statement...adequate to prevent injury to living man and
other vertebrate animals, vegetation and invertebrate
animals...7,

(i)f in the case of an insecticide, nematocide, fungicide or
herbicide when used as directed...shall be injurious to
living man or other vertebrate animals or vegetation, except
weeds, to which it is applied, or to 'the person applying
such economic poison...

The 1972 amendments to FIFRA provided that a registration should be
cancelled or denied if it appeared that the pesticide when used as
directed or according to common practice, "generally caused unreasonable
adverse effects on the environment..."9 The statute defined

"unreasonable adverse effects on the environment" to mean any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of any

pesticide."10

36

TOXICOLOGICAL TESTING

 

Whether the regulatory standard to be applied, in a use
cancellation/su5pension decision, was the "substantial question of
"safety" test or the "unreasonable adverse effects" test, the
Administrator was compelled by the statute to make "both a factual
determination on the evidence before him and an application of a legal
standard."11 The factual determination was based upon an evaluation of
the results of toxicological testing of the pesticide in question. In
the case of DDT, aldrin/dieldrin and chlordane/heptachlor the
administrative decision to cancel or suspend their registrations was
made on the basis of the results of carcinogenicity tests on one or more
rodent species and the extrapolation of these data to infer presumptive
human health effects.

It is virtually impossible to claim that a compound is "safe", that
is, that it presents absolutely no risk to organisms that come into
contact with it. Therefore, it is necessary to evaluate the degree of

hazard presented by a given compound over some period of time.

Acute Toxicity

 

There are numerous ways to assess the risk posed by any particular
chemical. Acute toxic effects may occur if a single, short term
exposure to a given compound is sufficient to cause adverse effects
(usually morbidity or mortality) in a test organism. The results of
acute toxicity tests are usually expressed as LDSOs or the lethal dose

of a substance that will kill 50% of the test organisms. As would be

37

anticipated the onset of symptoms for an acutely toxic substance are

severe and rapid.12

Chronic Toxicity

 

Often a substance exerts its toxic effect(s) only after prolonged
or chronic exposures. Of particular concern, for regulatory purposes,
is whether exposure to a compound at some time in an organism's life
will result in cancer at some later point in time. There are two
principle methods employed in determining. whether a substance may be a
carcinogen: (1) epidemiological studies involving pe0ple exposed to the

substance, and, (2) long-term tests on laboratory animals.

Epidemiological Studies"

 

Epidemiological evaluations are of limited utility in identifying
carcinogens. For one thing, they are relatively insensitive.

For something to be defined as a risk in an epidemiologic

study,...usually a large difference in rates of disease or a

large relative risk [have] to be found.13

...For example, the overall incidence of lung cancer in the

general population in 1970 was about forty cases for each

100,000 people. . .as the probability of an individual

contracting lung cancer in that year was thus about one in

2,500, an extremely large number of people would have [had]

to [have been] observed to ensure that there would be enough

cases of the disease to study.14
In addition, epidemiological studies are very costly and often difficult
if not impossible to conduct due to the usual lag period between the
initial exposure to a carcinogenic agent and the manifestation of the
disease. The "latency period", (that is, the time between exposure to
the carcinogenic agent and the appearance of a cancer), is usually

thought to be anywhere from 15 to 40 years. Furthermore, the human

38

p0pulation is often ubiquitously exposed to numerous carcinogenic
agents. It is often quite a formidable, if not impossible, task to
identify groups of peeple with sharply contrasting exposures to a
particular chemical agent.

Because of these problems...and because testing for

carcinogenicity of chemical substances is beyond the ethical

bounds placed by society on human experimentation, most data

for identifying potential cancer risks...come(s) from animal
studies.15

Species-to-Species Correlation

 

Fundamental to cancer research is the presumption that.what is
found to induce cancer in one species of animal must also be assumed to
induce cancer in others.16 Whether they occur in humans or experimental
animals chemically-induced tumors are, in general, more similar than
dissimilar to one another. This principle, known as the
"species-to-species extrapolation principle, is grounded in the fact
that [the] fundamental life processes in mammalian and other animals are
basically the same as those in humans."17 Thus, unless there is
compelling evidence to the contrary, a substance which is found to
induce cancer in a sensitive animal surrogate species, in a properly
designed and executed study, must be considered a presumptive human

carcinogen.18

Theory and Practice of Carcinogenesis Bioassgyg

Rodents are generally used as the surrogate species of choice in
carcinogenesis assays. There are several reasons for this. Mice and
rats have been used for over fifty years, and hamsters over thirty

years, in evaluating the carcinogenic potential of various environmental

39

agents. Over this period of time it has been shown that, "most
chemicals that cause cancer in humans...cause cancer in rodents.
although not necessarily in the same organ or in all species and strains
tested."19

The rat and mouse have been shown to be susceptible to the

carcinogenic action of a large variety of compounds and,

indeed, most of our knowledge of chemical carcinogenesis is

based on the use of these species. The hamster and guinea

pig are relatively resistant to the carcinogenic action of

several compounds which produce tumors readily in the rat

and mouse. On the other hand, no known carcinogens for the

hamster and guinea pig are inactive in the rat and mouse.20
Perhaps more importantly, all chemicals known to cause cancer in man,
with the possible exception of arsenic, also do so in experimental
animals.21

The carcinogen bioassay22 is a chronic toxicity study which usually
subjects the test animal species to a lifetime exposure to the substance
being evaluated. When using mice or rats as the test species, the
duration of exposure is usually 18-24 months. Typically the number of
animals used is limited--often not more than 600 animals of both sexes
and species.23

Different groups of animals are exposed to different levels of the
test agent up to and including the maximally tolerated dose (MTD).24
Theoretically, the MTD is the largest quantity of test agent
administered during a chronic study that will not result in excess
morbidity or mortality in these animals. "In practice, the MTD is
considered to be the highest dose that causes no more than a 10 percent
loss in weight compared to control animals."25

Fifty animals of each species and sex are normally tested at each

of two dose levels including a control (no compound) level. Animals are

examined periodically for signs of disease or overt toxicity. Often

40

animals are sacrificed at predetermined times, and their tissues
examined to evaluate the time to tumor date observed after continuous
exposure to the carcinogenic agent. At the termination of the study,
all of the animals remaining are sacrificed and their tissues preserved
for pathologic evaluations.

In order to compensate for the limited p0pulation numbers used in
these studies and, thus, their limited sensitivities the administration
of large dosages of the compound is usually required.

The need for large dosages of chemicals in some experiments
is a reflection of the facts (1) that some carcinogens are
much less potent than others and (2) that animal
experiments,...must make use of finite animal resources. To
illustrate this point, let us suppose that humans and rats
are equally sensitive to some chemical carcinogen which
causes one case of cancer in every 10,000 persons (or rats)
to which it is given. If 220,000,000 Americans were exposed
to this chemical, 22,000 cases of cancer would occur. On
the other hand, if fed to the typical 50 rats used in an
experiment, the chances that even one rat would get cancer
is one-half of one percent; 10,000 rats would have to be fed
the cheglical (at human dosages) to observe even one
cancer.2

The likelihood of obtaining a carcinogenic response is increased by
raising the dosage levels of carcinogenic agents. Furthermore, should
one obtain negative results in a study employing high doses one can have
greater confidence that the results obtained are a true reflection of
the carcinogenic potential of the compound in question.

There is a comon mythology that high doses of any chemical can
cause cancer in apprOpriately designed carcinogenesis bioassays. This
is simply not supported by the facts.

High doses of noncarcinogens may produce a variety of toxic
effects but will not produce cancer. The intrinsic
carcinogenicity of a chemical does not depend on dose level
although the proportion of animals develOping cancers and

the earliest time that tumors are detected are usually
related to dosage.27

41

Or in another light,
The bottom line on carcinogenisis testing is this. You can
drown an animal in a pool of some substance, suffocate an
animal under heap of it, or beat an animal to death with a
sock full of it, but if it isn't carcinogenic, you can't
give an animal cancer with it.2
Actually, only about 20% of those chemicals suspected of causing cancer,
because of their similarity to known carcinogens, have been demonstrated
to produce cancer in carcinogenesis bioassays.29
There are several inherent problems with extrapolating the results
of animal studies to man. First, one must assume that rodents and
humans are equally sensitive to the same toxic agent. Yet, for any
given substance, humans may be either more sensitive, equally sensitive,
or less sensitive than rodents to the carcinogenic or other toxic
effects of the chemical agent being investigated. 8y extension, the use
of this assumption can lead to over or understatements of risk depending
upon the type of test used and the animal species being studied.
For example, the lowest dose of thalidomide inducing birth
defects in pregnant women is 0.5 mg/kg/day; the
corresponding values for the mouse, rat, and dog are 30, 50,
.and 100 mg/kg/day, respectively. Thus, humans are 60 times
more sensitive than are mice to thalidomide, 100 times more
sensitiv than rats, and 200 times more sensitive than are
dogs.3 ...[C]ertain aromatic amines, such as
2-naphthalamine, are potent bladder carcinogens for man.
monkeys, and dogs, but not for rats, mice and other rodents,
in which tumors at other sites are produced.31
If one is to use the results of animal tests as valid indicators of
potential human harm then one nust also assume that there is a direct
correlation between the dose of a compound and the appearance of tumors
at that dosage level. This one-to-one correlation is conventionally
referred to as the linear dose-response extrapolation. Practically
Speaking it is almost impossible to verify this theory through direct

experimentation. Our collective inability to determine the presence or

42

absence of a "threshold" for carcinogens centers upon our lack of "hard
data" on the lower ends of the dose-response curve. However, in order
to err on the side of protection of public health it has become standard
practice "to assume that the extrapolation is linear."32 (See figure 1,
‘next page.) The inevitable conclusion one comes to is that on the basis
of experimental animal data, there is "no known method [to] predict a
safe human (exposure) level for carcinogens,...if...such safe levels for
humans exist at all."33

I FIFRA calls for the cancellation of a pesticide's registration if
the use of that compound results in adverse effects on non-target
organisms. The environmental effects of not only DDT, but also
aldrin/dieldrin and chlordane/heptachlor were thoroughly documented.
Yet, in the cancellation and cancellation/suspension hearings to follow,
the regulatory decision to curtail or eliminate the use of these
products from the marketplace were made not on the basis of their
environmental fate and effects but rather on the basis of their
presumptive human carcinogenicity. It was on this body of information
that the EPA cancelled the use registrations for the insecticides DDT,

aldrin/dieldrin and chlordane/heptachlor.

_D_1_)_T_

First synthesized in 1874, DDT (dichlorodiphenyltrichloroethane)

was not recognized as having insecticidal prOperties until 1939.34 DDT

was originally classified by the U.S. Army during World War II as a "top

secret." It was used militarily both in the Asian and EurOpean
campaigns, in dust form, for the control of typhus.

Most Americans became acquainted with pesticides in the
newsreels of World War II. Lice-ridden soldiers were filmed

43

Figure 1

1M

II-B

 

 

Rom
.§

Munich.

 

 

\

Don—v-

,' Diamofdoae-mponsenhtions. Cumlshowsasharpdooe-mponse curve;
curveII-A,asli¢htlydis lacedcumwithanidentialmidpoint. CurveII-Bisanefl'ectwitha
'broadermponse.(133

44

lining up in the streets of Naples to be fumigated with DOT.

They would disappear in a cloud of dust and emerge smiling

and obviously healthy.35
In the wake of World War II DDT was heralded as a way to eradicate
insect-borne diseases, such as malaria and yellow fever, and end foreVer
the plight of the farmer being at the mercy of crap-eating insects.36
The Nobel Prize for 1948, was awarded to Miiller, the Swiss chemist who
discovered DDT's broad insecticidal pr0perties.37

A familiar sight on sumer evenings during the post-war years was
the fogging machine moving up and down urban and suburban streets as
children played in and out of the dense clouds of DDT mist.38 Since the
children displayed no obvious ill effects from their DDT exposures the
public was lulled into believing that DDT was harmless.

Rachel Carson's book Silent Spring raised concern over the

 

widespread and often indescriminate use of pesticides. In the aftermath
of this publication many committees were established to evaluate the
critic's allegations that DDT--which had been used for over two decades
without any (apparent) ill-effectsuw'as a highly dangerous substance
which, (1) had collected in the food chain, (2) killed beneficial
insects, (3) upset the ecological balance, and, (4) posed a hazard to
aquatic, avian and human life.

The United States Food and Drug Administration, on April 4, 1969,
announced the seizure of 28,000 pounds of coho salmon from Lake
Michigan.39 The levels of DDT residues found in their tissues exceeded
the FDA's established tolerance limit. Sometime later that year, in
August, 1969, a three-day symposium was convened in Corvallis, Oregon to

discuss "the biological impact of pesticides in the environment."40 The

45

conferees reported that DDT in high concentrations caused physiological
damage to the nervous system, liver, and kidneys of test animals.41

As early as 1947, a study by Fitzhugh and Nelson,42 reported that
rats fed DOT displayed an increased incidence of liver tumors compared
to control animals. (It should be noted that rats are exceedingly
resistant to the develOpment of liver tumors.) In 1969, Innes, et
al .,43 demonstrated that DDT, as well as other insecticides, caused the
development of tumors in mice. The "Report of the Secretary's
Commission on Pesticides and Their Relationship to Environmental
Health"44 (hereinafter, the Mrak Report), stated that,

(t)he evidence for the carcinogenicity of DDT in

experimental animals is impressive and the Panel [the

Technical Panel on the Carcinogenicity of Pesticides] takes

no exception to the conclusions as to DDT recorded in the

JNCI [Innes Study] report of the National Cancer Institute

study. This study has demonstrated that DDT increased the

incidence of cancer in mice under the experimental
condi ti ons empl oyed.

 

Indeed, the Mrak Report further stated that the results of the
carcinogenicity studies they evaluated were significant at the 0.01
level .45 They recomended that the "exposure of human beings to [this]
pesticide...be minimized and that use of [this] pesticide be restricted

 

to those purposes for which...advantages to human health...outweigh the

 

 

 

potential hazard of carcinogenicity."47

EDF, in conjunction with the Western Michigan Environmental Action
Council and the National Audubon Society, filed a petition with the USDA
in October, 1969, requesting the issuance of cancellation notices for
all economic poisons containing DDT and suspension of the registrations
of these pesticides pending the completion of the cancellation

proceeding.48 On 20 November, l969, in response to the

46

cancellation/suspension petition, the Agriculture Department issued a
notice of intent to cancel the registrations of DDT for minor uses
including (1) use on shade trees; (2) tobacco; (3) in and around the
home, and, (4) in aquatic environments, marshes, wetlands, and adjacent
areas. In the Federal Register notice that followed, (25 November
1969), the Department stated that it "[was] considering cancellation of
any other uses of DDT unless it [could] be shown that certain uses
[were] essential in the protection of human health or welfare..."49

EDF objected to the Department's handling of the DOT issue. They
alleged (1) that the November cancellations were unenforceable, (DDT
could still be purchased by anyone and used for a disallowed purpose).
(2) that the cancellation notice should have includedpll registered
uses of DDT, and, (3) that DDT posed a great enough threat of harm to
man or the environment to warrant the Secretary to suspend the
registrations of all DDT uses.50

In order to obtain judicial relief for their grievances against the
Department's actions (and inactions), EDF filed a petition for review in
the U.S. Court of Appeals for the District of Columbia. The court held
in EDF v. Hardin51 that the case was to be remanded back to the

 

Department of Agriculture with instructions to the Secretary to either
issue the remaining cancellation notices or explain his reason for
deferring his decision to issue the same.

The Department's response to the court's orders was in the form of
an eight page statement of findings.52 The Secretary foUnd that (1) DOT
in large doses had produced cancer in test animals but its ‘effects in
small doses on man were unknown; (2) that DDT was toxic to certain

birds, bees, and fish; and that (3) DOT had important beneficial uses

47

associated with crap protection and disease vector control. (At the
time, total domestic sales (1970) were 11,966,196 pounds--98 percent of
which was used on cotton53.) Based upon these, and other, findings the
Secretary concluded "(t)hat the use of DDT should continue to be reduced
in an orderly, practicable manner which will not deprive mankind of uses
which are essential to the public health and welfare. To this end there
should be a continuation of the comprehensive study of essentiality of
particular uses and evaluations of potential substitutes."54 In effect,
while the Secretary admitted that the continued use of DDT 219 present a
hazard to man and the environment, he did not feel that.it posed an
imminent hazard which would have called for immediate suspension.

EDF again petitioned the Court of Appeals (D.C. Circuit) to review
the Secretary's findings and inactions. (During the pendancy of the
court's deliberations, the Department of Agriculture was divested of its
pesticide regulatory authority. Authority for regulation and
registration ofpesticides was transferred to the newly created
Environmental Protection Agency (EPA).) The court found that the
Secretary's refusal to suspend the remaining uses of DDT or to initiate
the formal administrative hearings to review DDT's registrations was
grounded upon an imprOper interpretation of FIFRA.

(T)he FIFRA requires the Secretary to issue notices and
thereby initiate the administrative process whenever there
is a substantial question about the safety of a registered
pesticide...(W)hen...he reaches the conclusion that there is
a substantial question about the safety of a registered item
he is obliged to initiate the statutory procedure that
results in...a public hearing. ...(O)ne important function
of that procedure is to afford the registrant an Opportunity
to challenge the initial decision of the Secretary. But the
hearing...serves other functions... Public hearings bring
the public into the: decision-making process, and create a
record that facilitates judicial review. If hearings are

held only after the Secretary is convinced beyond a doubt
that cancellation is necessary, then they will be held too

48

seldom and too late in the process to serve any of those
functions effectively.55

 

The decision of EDF v. RuckelshausS6 required the EPA to initiate
the administrative hearing process by issuing notices cancelling all
registered uses of products containing DDT. The court further
instructed the EPA to determine whether the available information on DDT
in Agency files constituted an "imminent hazard" warranting a suspension
order. EPA issued cancellation notices, pursuant to court order, on all
remaining DDT uses within 1 week of the Court of Appeals' decision (15
January 1971).57

On March 18, 1971, the Agency published its reasons for denying
suspension of products containing DDT.58 EPA elaborated its general
criteria for suspension as follows:

(T)his Agency ‘will find that an imminent hazard to the
public exists when the evidence is sufficient to show that
the continued registration of an economic poison poses a
significant threat of danger to health, or otherwise creates
a hazardous situation to the public that should be corrected
inmediately to prevent serious injury, and which cannot be
permitted to continue during the pendency of administrative
proceedings. An 'iminent hazard' may be declared at any
point in a chain of events which may ultimately result in
harm to the public. It is not necessary that the final
anticipated injury actually have occurred prior to a
determination that an 'imminent hazard' exists...
(S)ignificant injury or potential injury to plants or
animals alone could'jistiijy a finding of imminent hazard.”

In reaffirming his decision not to suspend the registrations for
DDT products, Ruckelshaus justified his position as follows. "The
present scientific evidence indicates that there would be no significant
hazard if only carefully limited amounts of DDT were released into the
environment by virtue of restriction of DDT to the most critical uses."
And for that reason the, "(p)recipitous removal of DDT from interstate

commerce would force widespread resort to highly toxic alternatives in

49

pest control... The widespread poisonings, both fatal and non-fatal,
which may reasonably be projected, present an intolerable short-term
health hazard."60 It is instructive to note the apparent conflict
between the criteria for suspension ("significant or potential injury to
plants or animals") and the justification for the continued use of DDT
during the pendency of the hearing process ("highly toxic
alternatives...may present an intolerable short term [human] health
hazard"). I have inserted the word "human" in the latter quotation
because it was upon the issue of chronic health risk to ggggg§_that the
insecticides DDT, aldrin/dieldrin and chlordane/heptachlor were
ultimately resolved in favor of cancellation. One must also be somewhat
sceptical of the Administrator's reasons not to cancel all uses of DDT.
The only significant use remaining at this time was for cotton pest
control for which there were numerous substitute chemicals available.
It was ironic that the Agency was fighting for the retention of this use
given the fact that the cotton insect complex was totally resistant to
DDT and had been since the mid-19505.

The consolidated cancellation proceedings on DDT began on August
17,,1971. The hearing lasted seven months with 125 witnesses, 370
exhibits, and 9,300 pages of testimony.“ Intervenors to the
administrative hearing, on the side of the Agency, included the
Environmental Defense Fund (EDF), the Western Michigan Environmental
Action Council and the National Audubon Society. The case against
cancellation was presented by Eli Lilly and. Company, H.P. Cannon and
Sons, the National Agricultural Chemicals Association and the Secretary

of Agriculture (Earl Butz).

50

The EPA and EDF position was that DDT was a nonspecific chemical
which indiscriminately killed target and non-target organisms alike.
Furthermore, once dispersed, DDT was an uncontrollable, durable chemical
that (1) persisted in the aquatic and terrestrial environments; (2)
collected in the food chain and was passed up to higher forms of aquatic
and terrestrial life; (3) that under certain conditions DDT or its
metabolites persisted for many years in soils; (4) that it could move
from the site of application via runoff and/or volatilization, and, (5)
proof of this could be found by its presence in areas geographically
remote from direct application sites and by it or its residues being
present in the tissues of pelagic (Open-ocean) animals.62

Industry's position was that "whatever harm to the environment
might be attributed to DDT (was the result of) misuse and overdosing
that occurred in years past."63 They did not challenge the assertion
that continued use of DDT on cotton and other crops in the South and
Southeastern U.S. would result in its appearance in the food chain and
in the marine environment. But they vehemently denied any allegations
which implied that DDT uses posed a threat to man or the environment.64

On the issue of carcinogenicity, EPA and EDF, presented evidence
demonstrating DDT's carcinogenic effects in laboratory animal studies.
The Bionetics Study sponsored by the National Cancer Institute fed 120
compounds to two strains, both sexes, of mice. DDT was one of a total
of 11 compounds to produce an elevated incidence of tumors. DDT induced
hepatomas in males and lymphomas in females at dietary feeding levels of
140 parts per million (ppm).65

Research conducted under the auspices of the International Agency

for Research on Cancer (IARC) of the World Health Organization were

51

performed in Lyon (France) and Milan (Italy). The Lyon and Milan
studies were multi-generational in design and ultilized 6000 mice from
both inbred and outbred strains. The Lyon study exposed male and female
mice to 2, 10, so and 250 ppm of DDT in the diet. DDT was found to
induce hepatomas in male mice at all dosages studied; only females at
the 250 ppm level displayed comparable results. The hepatomas were
found to have metastasized to the lungs or kidneys in 5 animals. The
Milan study demonstrated comparable results; increased hepatomas were
observed in male and female mice fed either 250 ppm or 100 ppm of DDT.:

Witnesses for EPA/EDF attesting to the positive correlation between
tumorigens (substances causing benign tumors) and carcinogens
(substances causing malignant tumors) included three members of the Mrak
Report's panel on carcinogencity: Dr. Umberto Saffiotti, Dr. Marvin
Schneiderman and Dr. Samuel Epstein. Their testimony formed the basis
for EPA/EDF's definitions of carcinogencity--the seven cancer
"principles." These principles asserted that,

-A carcinogen is any agent which increases tumor induction
in man or animals.

-Well-established criteria exist for distinguishing between
benign and malignant tumors; however, even the induction of
benign tumors is sufficient to characterize a chemical as a
carcinogen. ' ‘

-The majority of human cancers are caused by avoidable
exposure to carcinogens.

-Carcinogenesis is characterized by its irreversibility and
long latency period following initial exposure to a
carcinogenic agent.

-While chemicals can be carcinogenic agents only a small
percentage actually are.

-A carcinogenic agent may be identified through analysis of
tumor induction results with laboratory animals exposed to
the agent, or on a post hoc basis by pr0perly conducted
epidemological studies.

52

-Any substance which produces tumors in animals must be

considered a carcinogenic hazard to man if the results were

achieved according to the established parameter of a valid

carcinogenesis test.66

Industry counterarguments primarily addressed the high levels of
DDT which the test animals were exposed to in order to induce cancer;
the extrapolatability of animal results to man; and, the lack of m
evidence that DDT was a demonstrated human health hazard. The first
point was addressed by the chief of the unit on carcinogenesis, of the
IARC, Dr. Lorenzo Tomatis. Tomatis was supervisor of the Lyon study
used by EPA as evidence of DDT's carcinogenecity. He stated that,
"(t)here is no evidence that DDT has the same effect in man that it has
in our experimental animals insofar as the induction of hepatomas is
concerned. So far there is absolutely no evidence of that."57

Dr. Leon Golberg's testimony sought to understate the relevance of
animal data by drawing attention to the high levels of DDT needed to
elicit a carcinogenic effect in mice. He felt that "while the object of
the toxicologist is to seek out target organ effects elicited by high
doses, his purpose...is to provide guidance...Grossly aberrant pathways
and rates of metabolism that may exist at exaggerated doses make it
imperative not to assume that effects at these doses are necessarily
characteristic of the changes occurring at lower levels of exposure."68

Industry rested its rebuttal of the health hazard data

ultimately upon the lack of human-epidemiological data for DDT. In
essence their position was that the failure to find an effect was
absolute proof that there, in fact, was no effect. This position was

supported by the testimony of Dr. Jesse L. Steinfeld (Surgeon General of
the U.S.) and Dr. John Higginson, Director of IARC. Higginson claimed

53

that there was, "no evidence at present that during the recent part of
the last 25 years there has been a significant trend or modification in
trend in cancer patterns that would suggest a reasonable association
with the use of DDT in our present environment."69 The Surgeon
General's testimony augmented that of Dr. Higginson when he stated that.
"(i)f there were some very blatant disease caused by DOT it seems to me
we should have found it by now."70 The testimony of these two witnesses
ignored the fact that statistically relevant epidemiological studies
were virtually impossible to perform since there were no adequate
control pOpulations, i.e., persons who were not exposed to DDT. Also,
unless DDT caused a very rare form of cancer or other disease, it would
in all probability pg£_be detected by an epidemiological study.

NO evidence produced by the prOponents Of registration
established that DDT conferred anything but marginal benefits to cotton
farmers. And, as many substitute insecticides were available, the
continued registrations of DDT were clearly not essential.

In his Opinion and order, William Ruckelshaus concluded that the

Agency and EDF have established that DDT is toxic to
non-target insects and animals, persistent, mobile and
transferrable and that it builds up in the food chain. NO
label directions for use can completely prevent these
hazards. In short,...they have established the risk of the
unknown. That risk is compounded where, as is the case with
DOT, man and animals tend to accumulate and store the
chemical...(T)he risk to human health from using DDT cannot
be discounted...The possibility that DDT is a carcinogen is
at present remote and unquantifiable; but if it is not a
siren to panic, it is a semaphore which suggests that an
identifiable public benefit is required to justify continued
use of DDT. Where one chemical tests tumorigenic in a
.laboratory and one does not, and both accomplish the same
task, the latter is to be preferred...There is no persuasive
evidence of record to show that the aggregate volume of use

of DDT for all uses in question...will not result in
continuing dispersal and buildup in the environment.71

54

ALDRIN/DIELDRIN

 

"I mean there is no fooling around, the major issue is
cancer."72

.Aldrin and dieldrin, (A/D), are closely related cyclodiene
insecticides. (Aldrin is readily cOnverted to dieldrin by an oxidation
process both in the body and in the general environment.) They were
introduced into the United States as broad spectrum, nonsystemic,
persistent insecticides in 1948, by the Julius Hyman and Company. Two
years later, Shell Chemical Company, a subsidiary of Shell Oil, became
the exclusive distributor of A/D. In May, 1952, Julius Hyman and
Company was incorporated into Shell Chemical. From 1952 to 1977 A/D was
manufactured in the United States exclusively by Shell.

Until the mid-19505, A/D was sold primarily for use on cotton
against the boll weevil.. Its pOpularity for cotton insect control
began to decline as the insect pests of cotton became resistant to A/D.
(A/D sales declined from a high, in 1966, of 22 million pounds to about
12 millicni pounds in 197273.) After 1955, A/D were aggressively
marketed and sold for use in corn against the corn soil insect complex
(cutworms, wireworms, and rootworms). As of 1972, corn soil usage
accounted for 80 percent of total A/D sales; termite control,
constituting 15 percent of the market, was the second largest usage
category. In the eight state Corn Belt, A/D were used principally for
crOp insurance purposes rather than for treatment of actual
infestations. Still, this market accounted for sales of 7.6 million
pounds of aldrin in 1974; sales of dieldrin for the same year amounted

to 600,000 pounds.

55

Both aldrin and dieldrin are acutely toxic to humans in contrast to
DDT's extremely low acute toxicity. In the case of aldrin, poisoning
can occur via any of three exposure routes: ingestion, inhalation and/or
skin absorption. Severe symptoms may result from the ingestion or
dermal absorption of from one to three grams--especially in the presence
of liver disease. Renal damage, ataxia, tremors, convulsions, followed
by CNS (central nervous system) depression, reSpiratory failure and
death can occur from acute exposures. Over a prolonged period of time,
chronic expOsures may result in liver or hepatic damage.74

Like DDT, MD are highly persistent, lipOphilic compounds. Four
years after a single application of dieldrin, 50 percent can still be
recovered from a treated field. Grain and forage crOps grown on A/D
treated soils become contaminated with dieldrin residues. When
contaminated grains are fed to livestock the residues of dieldrin appear
in meat and dairy products. There is conclusive evidence that residues
of MD are present in the adipose tissue of nearly every member of the
U.S. population.75 The consumption of contaminated foodstuffs was
ultimately the major, if not the primary, source of human exposure.

On 3 December 1970, one day after the EPA formally came into
existence, the Environmental Defense Fund petitioned the EPA for the
cancellation and immediate suspension of all registered uses of A/D75,
on the basis of the severe environmental damage and carcinogenicity of
these compounds. One year ea lier, the Mrak Commission found both
aldrin and dieldrin to be carcinogenic compounds when tested in the
mouse.77 They recommended that,

the exposure of human beings to these (Compounds) be
minimized and that use of these pesticides be restricted to
those purposes for which there are judged to be advantages

to human health which outweigh the potential hazard of
carcinogenicity.78

 

 

 

56

In response, the Administrator of EPA, William Ruckelshaus, on 18
March 1971, issued notices of cancellation of MD based upon a finding
of a "substantial question of safety."79 The Agency's decision was
premised upon the legal distinction between the substantial question of
safety test, upon which all cancellation decisions are based, and the
"iminent hazard" test, which forms the legal standard for the issuance
of suspension notices.

The inherent dangers of MD considered by the Agency to present
substantial questions as to the safety of these products

are similar to those encountered with DDT...they result from
the persistence of dieldrin [since aldrin residues quickly
break down into dieldrin] in the environment and its
potential toxicity at low levels. Some studies indicate
that dieldrin alone, or in possibly synergistic combination
with DOT, has an equivalent potential for adverse effect on
non-target predatory wildlife resulting from its low level
toxicity intensified by its mobility and concentration up
certain food chains. The scientific data also indicate that
dieldrin, again like DDT, has affinity for storage in the
fatty tissue in a number of animals, including humans.
There are also similar carcinogenic data developed in the
laboratory from high dosage rates of dieldrin administered
to test animals.

Dieldrin and aldrin apparently have a lower threshold of
toxicity to warm-blooded animals than does DDT. In fact,
instances of non-lethal human poisoning have occurred in
those occupationally exposed to heavy concentrations of
dieldrin...Recovery...was slow but apparently complete.
These potential hazards deserve a full public airing iii the
administrative forum provided by the cancellation
proceeding.80

While admitting that dieldrin raised safety questions analogous to
those raised by DOT and that "there [were] also similar carcinogenic
data developed in the laboratory from...dieldrin administered to test
animals"31, Ruckelshaus refused to issue suspension notices for all

registered uses of A/D.

57

It should be remembered from the DOT decision that suspension was
indicated whenever an imminent hazard was believed to exist.
[This Agency will find that an imminent hazard...exists
when...evidence is sufficient to show that continued
registration of an economic poison poses a significant
threat of danger to health, or otherwise creates a hazardous
situation to the public...which cannot be permitted to
continue during the pendency of administrative
proceedings...It-is not necessary that the final anticipated
injury actually have occurred prior to a determination that
an 'imminent hazard' exists...(S)ignificant injury or
potential injury to plants or animals alone could justify a
finding of imminent hazard.82
EDF responded to the Administrator's decision not to suspend A/D by
appealing the Agency's refusal to the Court of Appeals for the District
of Columbia Circuit for review. (At the same time the Shell Chemical
Company exercised its statutory right to convene an administrative
hearing and also have the National Academy of Sciences select a
scientific advisory committee to review and evaluate the evidence
against A/D.)83
In March and May of 1972, one year after the Administrator's
initial decision on A/D, the scientific advisorylcommittee and the court
of appeals (respectively) issued their written Opinions. The committee
affirmed the EPA's decision that suspension was unwarranted.
Furthermore, it felt that notices of intent to cancel A/D uses on corn
soil, as a pre-planting seed dressing and for termite control were
unnecessary (these were the major uses of A/D - constituting
approximately 95 percent of domestic sales.)84 Two months later, (5 May
1972), the court of appeals remanded the case back to EPA for a more
in-depth discussion of the risks and benefits inherent in the continued
use of A/D. The court was especially troubled by the Administrator's

"one-sentence discussion" of A/D's carcinogenic risk--without

58

identifying any offsetting benefits which would demonstrate to the
court's satisfaction that the substantial question of safety identified
by the Agency did not also constitute an iminent hazard.

By definition, a substantial question of safety exists when I

notices of cancellation issue. If there is no offsetting

claim of any benefit to the public, then the EPA has the

burden of showing that the gubstantial safegy question does

not pose an imminent hazard to the public.
Especially when "the matter involved is as sensitive and fright-laden as
cancer."86

The following month, Ruckelshaus reaffirmed his cancellation
decision with one caveat; that he was contemplating the suspension of
certain uses of MD.87 (There is reason to believe that Shell was
anxious to avoid suspension at all costs. It reached an agreement with
the user/registrants (persons who purchased A/D directly from Shell) to
discontinue the majority of the suspicious uses including dust
formulations, aerial application and mothproofin933.) Concluding that
the evidence on the carcinogenicity of dieldrin was too uncertain, the
Administrator, in his final decision on NO (December, 1972), decided
that suspension of dieldrin or its uses was unwarranted.33:88

The cancellation hearing on the risks and benefits of MD did not
begin until August 7, 1973--nearly two and one-half years after the
original notices of cancellation were issued. One year into the
hearings, on August 2, 1974,89 the new Administrator of EPA Russell
Train, issued a notice of intent to suspend A/O.90 Shell Chemical had
refused an earlier request of the Agency to delay the manufacture of 10
million pounds of MD scheduled to begin on September 1, 1974. (Ten

million pounds of active ingredient would translate into 50 million

pounds of formulated product which would have to be disposed of

59

somehow). Train was concerned not only about the environmental risks
inherent in disposing of this quantity Of chemicals, if he decided in
favor of cancellation when the hearings were scheduled to end in four to
five months, but also the carcinogenicity of these insecticides. In his
statement of his intention to suSpend the registrations and production
of A/D, Train listed five factors which contributed to his finding that
the continued production and use of these chemicals constituted an
"imminent hazard" to public health:

(1) That even at low dietary levels of exposure (0.1 ppm)
dieldrin caused statistically significant increases of
tumors in both mice and rats.

(2) Measurable amounts of dieldrin were present in 96
percent of all meat, fish, and poultry sampled; 83
percent of all dairy products sampled; and, 88 percent
of all garden fruit.

(3) 99.5 percent of all Americans tested had measurable
amounts of dieldrin in their adipose tissues, the
average being 0.29 ppm.

(4) Because of their greater consumption of dairy
products, children are especially at higher risk of
dieldrin consumption per pound of body weight than any
other population group in this country, and

(5) ‘The average American daily dietary intake of dieldrin
subjects the pOpulation to an unacceptably high cancer
risk.

The suspension hearing, begun on 7 August 1974,92 was concerned
exclusively with whether A/D posed a cancer hazard to human beings, and
whether it provided any tangible benefits which would outweigh its
risks. The major areas of contention between the Agency/environmental
intervenors and the prOponents of continued registration, Shell Chemical
and the USDA, centered upon (1) the validity of the experimental animal-
carcinogenicity data, and (2) the relevance of such data to a presumed

carcinogenic effect in humans.

60

The position of EPA/EDF was formulated and summarized as the "nine
cancer prnciples", an elaboration and affirmation of the "seven cancer
principles" established during the DOT cancellation hearing. The nine
cancer principles were as follows:

(1) A carcinOgen is any agent which increases tumor
induction in man or animals.

(2) Well-established criteria exist for distinguishing
between benign and malignant tumors; however, even the
induction of benign tumors is sufficient to
characterize a chemical as a carcinogen.

(3) ‘The majority of human cancers are caused by avoidable
exposure to carcinogens.

(4) While chemicals can be carcinogenic agents,<ufly a
small percentage actually are.

(5) Carcinogenesis is characterized by its irreversibility
and long latency period following the initial exposure
to the carcinogenic agent.

(6) There is great variation in individual susceptibility
to carcinogens.

(7) The concept of a "threshold" exposure level for a
carcinogenic agent has no practical significance
because there is no valid method for establishing such
a level.

(8) A carcinogenic agent may be identified through
analysis of tumor induction results with laboratory
animals exposed to the agent, or on a post hoc basis
by properly conducted epidemiological studies.

(9) Any substance which produces tumors in animals must be
considered a carcinogenic hazard to man if the results
were achieved according to the established parameters
of a valid carcinogenesis test.93

In five separate feeding studies, involving three genetically
different strains of mice, A/D were clearly established as carcinogenic
agents (the mice were of inbred, outbred and hybrid strains). ‘The IARC
concluded that when mice and rats were exposed to dieldrin by the oral

route:

61

The hepatocarcinogenicity of Dieldrin in the mouse was
demonstrated and confirmed in several experiments, and some
of the liver tumors were found to metastasize. A
dose-response effect has been demonstrated in both sexes
with an increased incidence in females at the lWest dose
tested, 0.1 ppm in the diet.94
These conclusions were corroborated by Shell's own test results
which demonstrated that the increase in the incidence of tumors was
dose-related (all three strains of mice in seven tests had a high
increase in hepatocarcinogenicity).9S The incidence of liver tumors was
diminished at levels above 10 ppm due to dieldrin's acutely toxic
effects upon the test animals. At 0.1 ppm, the lowest level evaluated,
there was an increase in both benign and malignant tumors.96 'Those
tumors that did become malignant had an increased tendency to
metastasize to other parts of the body, especially the lungs.97
In both male and female mice‘ A/D shortened the latency period for
tumor develOpment.98 A/D increased the develOpment of tumors after mice
had been exposed to it for as little as two weeks; more pronounced
effects were apparent after an exposure of one month's duration.99
Simultaneous exposure to MD and DOT apparently has a synergistic
effect upon tumor develOpment. Mice were shown to have an increased
incidence of tumors when fed 50 ppm DDT. When mice received a diet
containing 50 ppm DDT plus 5 ppm A/D their incidence of tumors increased
dramatically; the incidence of malignant tumor formation in males
increased by a factor of four and females by a factor of eight when
compared with mice only exposed to DDT.
It is certainly clear from these observations that Dieldrin
and DOT have additive effects when it comes to
carcinogenicity. Further, the evidence indicates that
Dieldrin is primarily responsible for this...effect. leing
th 50 ppm group as the controls the carcinogenic effect of

the combined feeding of Dieldrin and DOT is very highly
significant by statistical analysis.100

62

The data available from tests on rats, while less extensive than
that on mice, was no less conslusive. Two studies, Tunstall I and FDA
1964, confirmed the carcinogenicity of MD in rats. A markedly
increased incidence of liver and other tumors was observed in exposed
animals. These findings take on an added significance since the strains
used hitme feeding studies had a low spontaneous rate of
hepatocarcinoma.101

The ultimate question in the A/D suspension hearing was whether A/D
could be considered a human carcinogen. "Because man's response to
carcinogens is similar to that of rodents, the finding that a substance
is carcinogenic in experimental animals indicates that it poses a
similar risk to man."102 In support of the EPA/EDF position, Dr.
Walter Heston testified that:

Knowing this, and knowing the general biological similarity
of mice and other mamalian species, including man, we can
reasonably expect that in a population of human beings
exposed to Aldrin-Dieldrin, cancer of some kind will occur
in some individuals, and these individuals will not have
been afflicted in the absence of these compounds...The human
pOpulation is so much more genetically diverse than any
laboratory animal, that if a chemical has been shown to be
carcinogenic by a significant induction in an laboratory
strain of mammal, we can reasonably and at at least
certain human beings would also resgond to the chemical by
develOping some kind of neOplasm.10

Dr. Don Stevenson, Director of Shell's Tunstall Laboratory made the
strongest rebuttal argument for the registration prOponent (Shell
Chemical). He and other Shell witnesses adamantly insisted that the
data demonstrating the carcinogenicity of MD in laboratory animals was
insufficient to support cancellation/suspension. Dr. Stevenson urged a
progressively escalating standard of proof for the (human)
carcinogenicity of MD. Dr. Stevenson's criteria for carcinogenicity

included:

63

(1) Induction of carcinogenicity must be statistically
significant at all dose levels.

(2) A uniformly positive dose-response relationship must
be found at all doses, even if there is competing
toxicity and high mortality at high doses.

(3) A causal association between A/D treatment and
carcinogenic effects cannot be sustained unless the
mechanism of action of the carcinogen can be
demonstrated.

 

 

(4) Conclusions on carcinogenic effects of MD cannot be
accepted until the possibility of unknown "augmenting
factors" has been excluded.

(5) A carcinogenic effect must be consistent and
reproducible in a series of different tests before it
can be accepted.

(6) The induction of liver tumors in mice is no indication
of carcinogenic effects, even if they are
unequivocally malignant.

(7) Tumor production in mice, even in various different
organs and even when replicated, cannot be accepted as
evidence of carcinogenicity.

(8) Even the finding of carcinogenic effects in two or
more animal species is unacceptable proof in the
absence of evidence in humans.10

Dru Stevenson's position was supported by the testimony of
Massachusetts Institute of Technology cancer specialist Dr. Paul
Newberne.

From a scientific standpoint,...the fact that chemicals,
carcinogenic in other species, produce hepatic nodular
lesions in the mouse, does not warrant the labelling of a
compound of unknown activity as a carcinogen simply because
it causes nodules in the mouse liver.105 [Upon reevaluation
of tissue slides alleged by Shell to display "hyperplastic
nodules", a team of independent patholo ists found an excess
incidence of liver cancer in all cases.

...(T)here is some evidence that a number of factors may be
involved in the induction of mouse liver lesions. Until
more is known about their role, it would be unsound to base
conclusions on carcinogenic activity on the sole induction
of mouse liver tumors, even assuming they are all cancers.
It is my feeling that mice as a species...should not be used
for safety testing.106

64

It is perhaps ironic that the Shell Chemical Company and its witnesses,
while critical of the "appropriateness" of mouse studies after A/D were
demonstrated to be carcinogenic in the mouse, predominately relied upon
mouse studies in support of the safety of continued use of MD.107

Dr. Samuel Epstein challenged Shell's assertion that one must know
the mechanism(s) of causality 29.13.22 one can establish that a compound
is a carcinogenic agent.

The emphasis.by Shell witnesses that knowledge of mechanisms
must be defined before any agent can be considered
carcinogenic [in man], even though this agent has been
demonstrated to induce carcinogenic effects in valid
experimental systems, can only be regarded as misleading in
the extreme. In fact, in spite of a very considerable
amount of research, the basic mechanisms of action of any
single carcinogen have not yet been elucidated. This
requirement of Shell would define away the entire field of
chemTcal ca rci nogenesi s. 1

 

 

In his Opinion on the suspension of MD EPA Administrator Train
rejected Shell's arguments that one must know the mechanisms by which a
compound exerts its carcinogenic effects and must have corroborative
human epidemiology data before one could state that A/D were
carcinogens.

Our knowledge of cancer mechanisms is still imperfect and it
may take many years before we understand the mechanisms with
certainty. Furthermore, epidemiological studies are
difficult or impossible to conduct on the effects of
aldrin-dieldrin...It is the carcinogenic effect of
Aldrin-Dieldrin, not the mechanism, that concerns us
here.109

 

 

Train was also presented with similarly inconclusive evidence in
his evaluation of the benefits of continued A/O use. At issue was
whether the "banning" of A/D would lead to yield reductions in corn. He
concluded that "the macroeconomic impact of the proposed suspension

order would be almost negligible",110 since: (1) most of the A/D used

65

was used prOphylactically, and, (2) substitute compounds were readily
available to replace the loss of A/D to corn farmers.

In October, 1974, EPA ordered a comprehensive ban on almost all
registered uses of MD. Under Train's decision existing stocks of A/D,
those manufactured prior to 2 August 1974, could still be sold and used.

EDF appealed the Administrator's decision on the narrow issue of
the continued sale and use of existing stocks of ND. (In reality, the
EDF wanted the Court of Appeals to affirm the validity of the "nine
cancer principles" and thereby establish, by legal precedent, a
regulatory tool which could be used by EPA to aggressively pursue
carcinogenic pesticides.)111 The Court of Appeals for the D.C. Circuit
wholly affirmed the EPA decision on NO finding that the "suspension
order represent(ed) a rational exercise of the broad discretion
conferred on the Administrator by the (FIFRA)".112 The decision of the
court also reaffirmed the legal standard for the finding of an "imminent
hazard" which would initiate suspension proceedings against a registered

pesticide.

CHLORDANE/HEPTACHLOR

 

Like aldrin/dieldrin, chlordane/heptachlor (C/H) are two closely
related cyclodiene insecticides. They undergo metabolic and
environmental transformation to persistent, stable and lipOphilic
epoxide derivatives: chlordane is transformed into oxychlordare and
heptachlor becomes heptachlor epoxide. These stable derivatives were
implicated as posing an imminent hazard to public health during the

cancellation/suspension hearings for C/H.

66

Since the late 19405, C/H had been exclusively manufactured and
sold by Velsicol Chemical Corporation. C/H had historically been used
in agriculture for the protection of corn against attack by soil
insects. Non-agricultural uses for C/H included treatment of homes for
termite infestation and as general insecticides for use around the home,
lawn, and garden. The agricultural uses of these insecticides was
declining long before their suspension in 1975, due to increasing insect
resistance and the introduction of less environmentally persistent
alternative insecticides. The suspension of A/D, temporarily increased
the agricultural use of C/H, reversing the declining market demand for
these insecticides.

In mid-1974, the Environmental Defense Fund (EDF) petitioned the
Administrator of the EPA, Russell Train to cancel and suspend all
registered uses for C/H.113 It based its petition upon the same grounds
as that for MB, namely ubiquitous environmental contamination and the
finding that C/H had been found to be carcinogens by the Mrak
Commission.114 EDF felt that the continued environmental and human
exposures to these compounds not only raised a substantial question of
safety, calling for the issuance of cancellation notices, but also posed
an imminent hazard to public health calling for their immediate
suspension.

On 18 November 1974, (almost one month after the termination of the
A/D suspension hearings), Russell Train issued a notice of his intent to
cancel115 all but two registered uses of C/H (The two non-cancelled uses
were: subsurface ground injection for termite control, and dipping
roots and tom of non-food plants). The cancellation was based upon a

finding that "the pesticides appear(ed) to pose substantial questions of

67

safety amounting to an unreasonable risk to man and the environment.116
The substantial question of safety was based upon six classes of
evidence:

(1) Information derived from laboratory experiments
suggested that low levels of heptachlor and
heptachlor epoxide (10 ppm and 0.5 ppm,
respectively) significantly increased the
incidence of liver tumors (including carcinomas)
in rats and mice.

(2) Residues of C/H had been found in the tissues of
fish, birds and wildlife.

(3) Residues of C/H had been found in meat, fish and
dairy products.

(4) Residues of C/H had been found in a 1970-72 human
monitoring study in over 90 percent of
hospitalized patient's adipose tissue.

(5) Residues of C/H had been found in the tissues of
stillborn fetuses, and in cord blood, and,

(6) Residues of C/H had been found in milk samples of
nursing mothers.11

The "nine cancer principles" developed during the A/D suspension

hearings, and later affirmed in EDF v. EPA, were presented in the

 

Agency's first pretrial brief of 1 April 1975, as "the most advanced
research findings and policy of both national and international cancer
experts and agencies" in support of the proposed cancellation.118 In
its reply brief Velsicol objected to the inclusion of principles number
2 and 7 which were concerned with the essential similarly between benign
and malignant tumors following administration of a carcinogenic agent
and the scientific inability to set "thresholds" for carcinogen5119,
respectively. They moved to have the validity of these principles
referred to a committee of the National Academy of Sciences for review.
As one would expect, EPA/EDF objected to Velsicol's motion. The grounds

for their Objection rested upon a finding that benign and malignant

68

tumors have synonymous scientific and regulatory implications in
carcinogenicity testing. Velsicol's motion to strike principles 2 and 7
was flatly denied by Judge Perlman (the same Administrative Law Judge
who handled the A/D hearings).120

On 29 July 1975, Train issued a notice of intent to suspend all
registered uses of C/H except those previously exempted in the
cancellation notice.121 The Administrator made his determination of an
"imminent hazard" to public health based upon: (1) new corroborative
evidence on the carcinogenicity of C/H, and, (2) the anticipated 12-18
month duration of the cancellation hearing which would result in an
additional release of 38 million pounds of C/H into the general
environment. In his notice of intent to suspend Train adapted the
cancer principles develOped during the. cancellation hearings on NO and
C/H as "the basis for evaluation" of cancer risks, insuring their
incorporation during the suSpension proceedings. The Administrator's
finding of facts were as follows:

The use of animal test data to evaluate human cancer risks
has been widely accepted by the scientific comunity and by
public policy-making agencies. Such data are particularly
appropriate because the relatively short life-span of test
animals allows for testing for the entire latency period for
tumor development and because of our relatively
well-develOped understanding of the pathological development
of tumors in mice and rats. When compared to the millions
of peOple who may be exposed to a pesticide, the number of
animals used in tests to evaluate oncogenicity is extremely
small. The variability of human response to carcinogens is
generally greater than that of the test animals.
Epidemiological cancer data are desirable, but because Of
the long latency period of tumor induction in humans,
because of frequently encountered widespread contamination
which makes it impossible to establish an uncontaminated
control group and because of the obvious ethical and legal
problems associated with conducting cancer research on
humans, reliable epidemiological data are rarely available.
Accordingly a positive oncogenic effect in test animals is
sufficient to characterize a pesticde as posing a cancer
risk to man. By the same reasoning, negative results from

69

oncogenic effect in test animals is sufficient to
characterize a pesticde as posing a cancer risk to man. By
the same reasoning, negative results from oncogenic animal
tests have only limited significance. The number and
sensitivity of the test animals as compared to the general
human population are the principal reasons for this limited
utility. Because Of these inherent limitations of animal
testing a pesticide that induces tumors in experimental
animals at any dose level must be considered to be a
carcinogen. As noted above, negative results are of limited
value since they do not rule out the possibility that the
chemical will induce tumors in test animals if, for example,
the number of exposed animals or the length of exposure were
increased. Although a nO-effect level may theoretically
exist for carcinogens, as yet there is no scientific basis
for establishing such a level. Thus, human exposure to a
carcinogen at levels below those which induced positive
effects must be considered to present a cancer risk.
Finally, although the distinction between "benign" and
"malignant" tumors is of ppimary importance to the
individual, it is not a meaningful distinction in
determining the cancer hazard to man on the basis of tests
conducted on laboratory animals. Given the increasing
evidence that many "benign" tumors can develOp into cancers,
for purposes of determining whether a pesticide poses a
cancer hazard to man on the basis of laboratory experiments,
the terms "benign" and "malignant" should be considered.
synonymous.1

The suspension hearing on C/H began on 12 August 1975, with ALJ
Perlman presiding.123 The regulatory battle to ban C/H, like the
regulatory battle to ban A/D, centered upon the carcinogenicity of C/H.
Unlike A/D, Velsicol disputed the finding that what its pathologists
diagnosed as "hyperplastic" nodules were in fact neoplastic nodules and
"frank" carcinomas of the liver.124

With the exception of two studies, a 1965 FDA mouse study which
served as the basis for the Mrak Comission to conclude that heptachlor
and heptachlor expoxide were carcinogenic compounds and a 1975 study
performed by NCI, the main body of information on C/H, nine studies,
were unpublished.125 It was on the basis of this unpublished data base
that C/H were claimed by the manufacturer/registrant to be
noncarcinogenic and safe. The studies were generated under contract to

Velsicol by two comercial testing laboratories: the Kettering

7O

Laboratories of the University of Cincinnati, Ohio and the International
Research DevelOpment Corporation (IROC) of Mattawan, Michigan. Both
laboratories found the compounds to be noncarcinogenic. It is
especially illuminating to note that while the Kettering study on rats
did find a dose-related excess of "hepatomas" in the treated animals
they concluded that, "(t)he data Obtained from these animals (were) not
sufficient to implicate Heptachlor epoxide as the agent responsible for
the develOpment of these hepatomas."126

Velsicol's position throughout the C/H suspension proceeding was
that the diagnosis Of cancer was a subjective matter among pathologists.
In order to dispel the controversy surrounding the uncertain diagnosis
Of the liver pathology slides alleged by Velsicol to contain
hyperplastic nodules, EPA assembled a team of five independent
pathologists, headed by Dr. Melvin Reuber (an expert in the field of
rodent liver pathology) to re-examine the slides. In every case Reuber
and his team found a high incidence of unequivocal liver cancers.
(There were no discrepancies in the diagnoses of industry pathologists
and the independent pathologists with respect to untreated control
animals and positive control animals exposed to acetylaminofluorine.)

In his Opinion Judge Perlman on 12 December 1975, concluded that

heptachlor and its metabolite aggear to be a carcinogen in

the mouse on the basis of the an t e IROC studies and
may be a carcinogen in the CFN rat on the basis of the

et ering study and that chlordane a ears to be a
carcinogen in the mouse on the basis of the IROC study...127
Judge Perlman used the terms "apear to be" and "may be" because of the
absence of metastasis or meaningful invasion of the liver tumors to

other sites in the body. As he concluded, "we are hesitantly unwilling

 

at this time to find that heptachlor and chlordane are conclusively

 

carcinogens in laboratory animals."128

71

Perlman's decision was rejected by Train on 24 December 1975, by
the issuance of an order suspending the registrations of C/H. Train
emphasized that in failing to find an "imminent hazard" in the continued
use of C/H Judge Perlman misapplied both the pertinent statutory
provisions of FIFRA and the legal precedents defining the legal standard
to be applied in this case. FIFRA defined an "imminent hazard" as,

a situation which exists when the continued use of a
pesticide during the time required for a cancellation
proceeding would be likely to result in unreasonable adverse
effects on the environment.1
Such an unreasonable adverse effect was defined as,
any unreasonable risk to man or the environment taking into
account the economic, social, and environmental costs and
benefits of the use of any pesticide.130
In the view of the Administrator, therefore,

the FIFRA and the cases make two points clear...with regard
to a suspension proceeding. First, it is not necessary to

. find "conclusively"that actual harm to man will occur if
the use of the pesticide in question is continued; rather
the finding required is that continued use during the
cancellation proceeding is "likely" to result in
"unreasonable risk" to man or the environment. Second, the
propriety of suspension turns upon an analysis in which the
risks are balanced against the benfits...the mere fact that
the evidence on either of these issues...is not complete, or
that more evidence may be expected to be develOped in the
cancellation proceeding, is not a reason to deny
suspension. -

Both Velsicol and EDF appealed the Administrator's decision to the
U.S. Court of Appeals for the D.C. Circuit. Velsicol, supported by the
Secretary of Agriculture as intervenor, argued that substantial evidence
did not support the Administrator's conclusion that continued use of
chlordane posed an "imminent hazard" to human health. They contended,
furthermore, that in a suspension proceeding the ultimate burden of
proof rests at all times on the Administrator. EDF, on the other hand,

felt that the order did not go far enough. They sought an injunction

72

against the continued production and use of C/H on corn pests until
1 August 1976. In addition, they objected to the Agency's decision to
allow the sale of C/H which remained in stock as of 29 July 1975 (the
day the notice of intent to suspend was issued). In its Opinion the
Court of Appeals, in large measure, affirmed the Administrator's finding
of fact and policy.132

On 6 March 1978, the three years of administrative hearings ended
with a settlement agreement reached between the Agency, Velsicol and
EDF. Under'the terms of the agreement, Velsicol was to gradually phase
out all agricultural uses of C/H over a-five-year period ending in
September, 1982. The settlement provided for the production of no more
than 7.25 million pounds of C/H per year and only certified applicators
and commercial seed treatment companies were to be permitted to use the
insecticides during the phase-out period.

The cancellation and suspension of the use registrations for DDT,
aldrin/dieldrin, and chlordane/heptachlor arose as a direct result of
public participation in pesticide policy decisions. It is probable that
these insecticides would still be on the market if non-agricultural
interests had been barred from fully participating in formal and
informal pesticide hearings. In the next section (Chapter 4) we shall
examine a rulemaking proposal EPA published in August, 1980, which would
have significantly abridged the rights of non-agricultural interests to

participate in pesticide registration decisions.

«boom

14.

15.

16.

17.
18.

73

REFERENCES

Carson, Rachel: Silent Spring, Houghton Mifflin Company, New
York, 1962, p. 18.

 

Ibid.
Supra, note 1, at 23.
37 Federal Register 13369, 7 July 1972.

Environmental Defense Fund v. Ruckelshaus, 439 F. 2d 584 (D.C.
Cir. 1971).

 

7 U.S.C.5135(Z)(2)(C)(1970).
7 U.S.C.§135(Z)(2)(d)(1970).
7 U.S.C.§135(Z)(2)(g)(1970).
FIFRA §3(c)(5), 6(b).

FIFRA §2(bb).

Supra, note 5.

Office of Technology Assessment, "Environmental Contaminants
in Food," Congress of the United States, 79-600207, p. 59.

Schneiderman, Marvin A.: "Regulation of Carcinogens in an
Imprecise World", in, Management of Assessed Risks for
Carcino ens, Annals of the New York Academy ofSciences, TE
353, 33., William J. Nicholson, p. 223, 1981.

 

Epstein, Samuel S.: The Politics of Cancer, Sierra Club
Books, San Francisco, 1978, p. 401

 

Toxic Chemicals and Public Protection, A Report to the
President by the Toxic Substances Strategy Committee, May,
1980, p. 128.

 

Supra, note 14, at 57.
Ibid.

It must be recognized that the disease known as cancer is a
complex, multi-staged disease process. "This multi-staged
concept of carcinogenesis...has been a major advance in
placing some order on the complex carcinogenic process. In
recent years [the] initiation/promotion model of
carcinogenesis has been shown to be applicable to the
understanding of tumorigenesis in several organs of many
species". see, Trosko, J.E., et al.: "The Use of Mammaliam
Cell MutantF't'o Study the Mechanisms of Carcinogenesis", in,

19.
20.

21.

22.

23.
24.
25.
26.

27.
28.

29.

3o.
31.

74

GANN Mono raph on Cancer Research 27:159, published by the
J’apanese cientific Societies Press, Tokyo (1981). Cancer
researchers are now able to Operatively classify chemical
substances as cytotoxic agents (substances that kill cells
outright); initiating and/or promoting agents; teratogenic
agents capable of inducing birth defects in exposed gestates;
mutagenic agents capable of inducing structural alterations in
DNA, etc. Although these advances have increased the accuracy
of our ability to discriminate between different types of
physiological events, they have not increased the accuracy,
validity, or acceptability of trans-scientific decisions.

 

Supra, note 16, at 128-129.

National Academy of Sciences, National Research Council Food
and Nutrition Board, "Problems in the Evaluation of
Carcinogenic Hazards from Food Additives, Food”Protection
Committee Phblication 749,‘Washington,iD?C2; 1960.

 

 

Sunderman, F. W., Jr.: "A Review of the Carcinogenicities of
Nickel, Chromium, and Arsenic Compounds in Men and Animals,"
Preventive Medicine, Vol. 5:279-294, 1976.

 

Sontag, J. M., N. P. Page, and U. Saffiotti. "Guidelines for
Carcinogen Bioassay in Small Rodents," DHEW Publication No.
(NIH) 76-801, Government Printing Office, Washington, D.C.,
1976.

Supra, note 15, at 131.

Supra, note 22.

Supra, note 20, at 62.

Epstein: "Environmental Determinants of Human Cancer" in
Cancer, 34 Cancer Research 2425 (1974).

Toxic Chemicals and Public Protection, supra, note 15 at 132.

 

Hines, William R. and Judith Randal, Journalists, Washington,
D.C. in, The Politics of Cancer, supra, note 14, at 54.

 

Rogers, Hon. Paul G.: Text of Remarks Presented at the
"Symposium on Legislation in Preventive Oncology," at the
Second Annual Meeting of the American Society for Preventive
Oncology; March 10, 1978.

"Environmental Determinants of Human Cancer," Supra, note 26.
Clayson, D. 8., and R. C. Garner, "Aromatic Amines and Related

Chemicals," in C.S. Searle, ed., Chemical Carcinogenesis,
American Chemical Society, Washington, D.C., I976.

 

32.

33.
34.
35.

36.
37.

38.
39.

40.

41.

42.

43.

44.

45.
46.
47.
48.

75

Rauscher, Frank, Jr.: former director of the National Cancer
Institute from remarks made at a roundtable on saccharin. 21
April 1977.

"Environmental Determinants of Human Cancer,I supra, note 26.

37 F.R. 13369, July 7, 1972.

Wellford, Harrison: Sowing the Wind, Grossman Publishers, New
York, 1972, p. 223.

 

Silent Spring, supra, note 1, at 29.

 

Newspaper Enterprise Association, Inc., The World Almanac, p.
453, (1970).

Supra, note 35.

Press Release, United States Food and Drug Administration,
April 4, 1969.

"The Biological Impact of Pesticides in the Environment";
18-20 August, 1969, Oregon State University, Corvallis,
Oregon.

See, unpublished papers of Ortega, "Pathology of DDT and
Dieldrin in Rats"; Revzin, "Effects of Endrin in Birds and
Monkeys"; VanGelder, "The Electro Physiological and Behavioral
Effects of Insecticides in Sheep"; Woolley, "Effects of DDT on
the Nervous System of the Rat"; supra, note 40.

Fitzhugh and Nelson, Journal of Pharmacologpand Experimental
Therapeutics, 89:18 (19471.

 

Innes, et al., "Bioassay of Pesticides and Industrial
Chemicals for Tumorigenicity in Mice: A Preliminary Note," 42
Journal of the National Cancer Institute 1101 (1969).

 

"Report of the Secretary's Comission on Pesticides and Their
Relationship to Environmental Health", Parts I and II, U.S.
Department of Health, Education, and Welfare, December, 1969,
p. 471.

.;gig;, (emphasis in original).

Op. cit., p. 470.

1213;, (emphasis added).

Farrar, Michael, Blaine Fielding, and John Kolojeski,

"Respondent's Brief in Support of Proposed Findings,
Conclusions and Order" (EPA Hearing, April 5, 1972), p. 12.

 

49.
50.
51.
52.

53.

54.
55.
56.
57.
58.

59.
60.
61.

62.
63.
64.

65.
66.
67.
68.
69.
70.

76

34 Federal Register 18827.
Environmental Defense Fund, Newsletter of 8 January 1970.

EDF v. Hardin, 428 F.2d 1093 (1970).

 

Statement of Reasons Underlying the Decisions on Behalf of the
Secretary With Respect to the Registrations of Products
Containing DDT, 29 June 1970, p. 13.

37 Federal Register 13369, Consolidated DDT Hearings, Opinion
and Order of the Administrator, 30 June 1972.

Supra, note 52.

EDF v. Ruckelshaus, 439 F.2d 584 (1971), at 594-595.

 

Ibid.

Farrar, et al., Op. cit., at note 48, p. 6.

"Reasons Underlying the Registration Decisions Concerning
Products Containing DDT, 2,4,5-T, Aldrin and Dieldrin."
Before the Environmental Protection Agency (March 18, 1971), 1
ELR 30028, March, 1971.

Ibid. (emphasis added).

Ibid.

 

Battista, S. Gail: "The Conviction of DDT," BNA Environment
Reporter, Monograph No. 14, 1973, p. 7.

Consolidated DDT Hearings, Op. cit., at note 53, p. 13370.
Ibid.

' DDTl Selected Statements From State of Washington DDT Hearingg

HEld in Seattle, October 14, 15,76, 1969, and other Related
Va ers, Tpubli shed by the DOT Producers of the United States,
December, 1970). pp. 216-258.

Innes, et al., Op. cit., at note 43.

Epstein, Samuel, M.D., Op. cit, at note 14, p. 256.

Battista, S. Gail, Op. cit., at note 61, p. 12.

EPA Hearing, Vol. 50, pp. 6048 (December 9, 1971).

 

Battista, S. Gail, op. ci , at note 61, p. 12.
Ibid.

71.
~72.

73.
74.
75.
76.
77.
78.
79.
80.

81.
82.
83.

84.

85.
86.
87.
88.

89.

90.
91.
92.

77

37 FR 13369, 13373 (1972)

In Re: Shell Chemical Company, FIFRA Dockets No. 145, et al.,
fn. 13. (hereinafter, FIFRA Docket No. 145).

Supra, note 14, at 249-250.

FIFRA Docket NO. 145

121g;

1219;.

Mrak Report., supra note 44., p. 470.
Ibid.

 

Supra, note 58, at 30033.
EDF v. EPA, (D.C. Cir., May 5, 1972), reprinted in 2 ELR

Ibid.
Ibid.

 

Spector, Phillip)|..: "Regulation of Pesticides by the
Environmental Protection Agency", 5 Ecologvaaw Ouarterty
233, (1976). p. 240.

 

Report of the Aldrin-Dieldrin Advisory Committee to William D.
Ruckelshaus, Administrator, Environmental Protection Agency.
March 28, 1972.

Supra, note 80, at 20234.

Ibid.

 

37 Federal Register 12904 (1972).

"EPA Delays Ban on Cancer-Producing Pesticide Dieldrin",«4
Environmental Law Reporter 10104, 10105; August, 1974.

 

See, Opinion of the Administrator, Environmental Protection
Agbncy, on the Suspension of Aldrin-Dieldrin, 39 Federal
Register 37246, 37265 (1974) [hereinafter, cited as
Administrator's Opinion].

Administrator's Opinion, supra, note 89, p. 37247.
Ibid.

 

Supra, note 74.

93.

94.
95.

97.
98.

99.
100.

101.
102.
103.
104.
105.

106.
107.
108.

109.
110.
111.

112.

113.
114.
115.

78

Epstein, supra, note 14, at 256.
EPA Exhibit S-17, pp. 143-144.
EPA, Exhibit S-21, pp. 2-3, FIFRA Docket No. 145, HELR 30023.

Shell Exhibit S-3A, Table Data 1, FIFRA Docket No. 145, HELR
30023.

Shell Exhibit S-3A, Table Data 1, Table Data 3, HELR 30023.
EPA Exhibit 50, pp. 2-13; EPA Exhibit S-I, p. 9.
EPA Exhibit 43-E, Table 5.

Statement of Dr. Melvin Reuber, EPA Exhibit 42, p. 26 FIFRA
Docket No. 145. '

FIFRA Docket No. 145.

.1918;

121g, EPA Exhibit S-11, 5 and 7.

Epstein, supra note 14, p. 259-260.

Newberne, Paul: "Statement of Testimony for A70 Hearings
Sgspension Phase," Shell Exhibit 59, FIFRA Docket No. 145, at
Iplgg, at 20.

Administrator's Opinion, 39 F.R. 37268, fn. 42.

Recommended Decision, FIFRA Docket No. 145, etafl. 20
September 1974, fn. 19, p. 53.

Administrator's Opinion, supra note 89, at 37269.
Administrator's Opinion at 7271.

Personal Communication; J.A. Warren, Bill Butler, William
Ruekauf.

EDF v. EPA, (Court of Appeals, D.C. Circuit), 4 April 1975.
3.

Ruekauf, William; personal communication.
Mrak Report, supra, note 44, at 470.
Notice of Intent to Cancel Registrations of Certain Pesticide

Products Containing Heptachlor or Chlordane, EPA, November 19,
1974; 5 ELR 10015, January, 1975.

116.
117.
118.

119.

120.
121.

122.
123.
124.

125.

126.
127.
128.
129.
130.
131.

132.

79

Ibid.

Ibid.

U.S. Environmental Protection Agency, Office of the General
Counsel, Attorney for Respondent, "Respondent's First Pretrial
Brief," in Re: Velsicol Chemical Corporation, et.al.,
Consolidated Heptachlor/Chlordane Hearings, FIFRA Dockets No.
336, et.al., 1 April 1975.

Velsicol 's first prehearing brief, FIFRA Dockets 336, et.al.,
1 May 1975.

Epstein, supra note 14 at 276.

"Notice of Intent to Suspend and Findings of the Imminent
Hazard Posed by Registrations of Pesticides Containing
Heptachlor or Chlordane," 41 Federal Register 7552, 19
February 1976.

Ibid., at 7554.
Ibid., at 7555.

ngerplasia is an increase in cell number. Neoplasia
literally means new growth. A neOplasm is an abnormal growth
of tissue, the growth of which exceeds and is uncoordinated
with that of normal tissues and persists in the same excessive
manner after cessation of the stimuli which evoke the change.
A carcinoma is any malignant neoplasm of epithelial cell
origin cferWed from any of the three germ layers. For a more
detailed discussion of these processes see, Robbins and
Cotran: Pathologic Basis of Disease, Zfi'd—Edition, W.B.
Saunders and‘COmpany, (1979), Chapter 5.

 

 

 

 

Epstein, S.S.: "The Carcinogenicity of Heptachlor and
Chlordane", Science of the Total Environment 6: 103-154
(1976).

 

41 FR 7566, (1976).
41 FR 7567.

1219s. _

7 u.s.c. 5136(1).'
7 u.s.c. §136(bb).

41 FR 7574 Decision of the Administrator on the Suspension of
Heptachlor-Chlordane (1976).

EDF v. EPA, 548 F. 2d 998, (1976).

 

80

133. Casarett and Doull: Toxicolo : The Basic Science of Poisons
Macmillan Publishing Cbhpany, nc., New York, (19751 at 11.

 

Chapter 4

A Critique of the Preposed Amendments to EPA's Current

Rules of Practice Governing Pesticide Hearings

Since its inception EPA has utilized a formal adjudicatory hearing
approach in its use cancellation/suspension proceedings against the
pesticides DDT, aldrin/dieldrin, and chlordane/heptachlor. When the
Agency has issued notices of intent to cancel1 certain use registrations
of a problem pesticide, the application of trial-type procedures has
often resulted in protracted hearings. The reason for this is simple:
FIFRA allows for the continued sale and use of "suspect" pesticides
during the pendancy of a cancellation decision.2 Thus, a registrant has
a strong economic incentive to use every legal maneuver available to him
to prolong a cancellation hearing.

"Both the formality of the hearings and the repetitive wrangling
over science policy issues consume a great deal of agency and litigant
time and resources."3 On 7 August 1980,4 EPA published a rulemaking
prOposal which would have significantly amended the procedures used by
the Agency for conducting adjudicatory hearings under Section 6 Of
FIFRA. In the preamble to this proposal, EPA stated that,

The objective of [this] proposal [was] to make the Agency's

procedures for identifying and assessing potential problem

pesticides, and implementing regulatory decisions concerning

them more open, responsive and efficient. The fundamental

theme...is to create an integrated system in which decisions

about registration or cancellation of problem pesticides are

made in the RPAR process...and in which adjudicatory

hearings are utilized primarily to probe and challenge
decisions reached in the RPAR process, atter appropriate

 

 

 

 

 

81

82

screening to identify disputed fact questions which [could]
profitably be illuminated through the use of trial-type
procedures.5 '

The Agency alleged that "these changes [were] designed to enhance
public participation in the process."6 Yet, "EPA's proposed
RPAR/Hearing Reform regulations [not only] unlawfully abridged the right
of [registrants and other adversely affected persons]7 to an evidentiary
hearing quaranteed by Section 6 of FIFRA"8 and the Administrative
Procedures Act (APA)9 but also significantly restricted the rights of
intervenors to meaningfully participate in a hearing, should a request
for a hearing be granted by the Agency. .

The ultimate effect of these proposed rules would have been to make
public participation a hollow exercise in the formulation of pesticide
regulatory policy "with the Agency internalizing most if not all of the
critical value judgements involved"10 in their regulatory decisions.
Through the proposals put forward in this rulemaking the Agency sought
to achieve an administrative/"functional" resolution to what is really a
polycentric controversy by infusing a managerial decision-making model
into the realm of public policy formulation. Where there exist,

...complex problems involving large numbers of interested
parties the concept of a single best solution is misleading.
Quantitative techniques of decision making are of great
value in solving many problems; however, they offer little
prospect of serving as an impartial, irrefutable arbiter of

the conflicts of interest involved in large policy
problems.11

I . PROPOSED RULES

 

The proposed rules contained three principal elements: (A) the
merging of the RPAR process with the Section 6 Hearing, (8) the

establishment of a screening mechanism for cancellation hearings, and,

83

(C) modifications of the rights of intervenors to fully participate in

administrative hearings.

A) MERGING of the RPAR PROCESS with the

 

FIFRA§ 6 HEARING PROCEDURES

 

The Rebuttable Presumption Against Registration (RPAR) process,
initiated in mid-1975, was "designed primarily as a mechanism for
identifying pesticide uses which might pose substantial questions of
safety...and providing for a relatively brief informal exchange between
the Agency and other interested persons on...whether a substantial
question of safety in fact existed."13 It was never intended to replace
pesticide cancellation hearings.

(T)he agency implemented [the RPAR process] in response to
industry complaints that the agency was deciding whether to
issue notices of intent behind closed doors and to
environmentalist complaints that it was scrutinizing too few
pesticides.14

As the RPAR system presently operates, there are two stages in the
proceedings that provide for the receipt of public comments and
submission of rebuttal evidence: at the initial (PD 1) publication
phase and at the final publication (PD 2/3) phase. Should the
Administrator decide that an RPAR has not been successfully rebutted,
under the proposed regulations the RPAR "record" would automatically
form the evidentiary foundation for any future cancellation
proceeding.” This, i.- effect, constitutes the fusion of the RPAR
process with the FIFRA §6 Hearing procedures. As the Agency stated in
the preamble to this prOposal,

(t)he fundamental theme...is to create an integrated system

in which decisions about registration or cancellation of
problem pesticides are made in the RPAR process...[wherein]

84

adjudicatory hearings [would be] used...to probe and
challenge decisions reached in the RPAR process.1

The RPAR record furthermore, (irrespective of how irrelevant, immaterial
or fallacious the information contained therein), would make up the
entire body of evidence for such a § 6 proceeding "unless certain
procedural hurdles were overcome to demonstrate that introduction of
additional evidence (through direct testimony or cross-examination) was

warranted."17

B) THE SCREENING TESTS

 

Under the proposed regulations, a registrant or other party
adversely affected by a Section 6(b) notice would not be automatically
entitled to an adjudicatory hearing upon timely request to the agency
for a hearing. "The proposed regulations require the proponent of a
formal hearing to identify those issues for which adjudicatory
procedures would aid in clarifying issues and answering factual
questions."18 The keystone of the Agency's hearing reforms was a set of
"screening tests" which would have been applied in hearings following a
notice of intent to cancel.19 The screening tests would have been used
to determine the extent to which the Agency would permit the
introduction Of additional evidence, cross-examination, and referral of
scientific issues to the National Academy of Sciences. As the preamble
stated:

The broad purpose of these tests is to ensure that formal

hearings are focussed on the types of issues they are best

qualified to address, and do not expend time and resources

on matters which have little prospect of being further

clarified or achieving decisional significance.20

The following criteria were to be used to guide the Agency's application

of the screening tests:

85

[A] party requesting further proceedings [must] show that:
[i] a genuine and substantial question of fact is involved;
[ii] the proceedings at issue are likely to resolve the
issue; and [iii] the resolution of the issue one way or
another has the potential to change...the outcome of the
proceedings.21

Should a party request "further proceedings" (that is, an
evidentiary proceeding for the introduction of additional evidence,
through direct testimony or cross-examination) he would be under an
affirmative duty to demonstrate to the presiding officer (an ALJ) that
each item which he wished to introduce into evidence had satisfied each
of the screening tests. The screening tests included,

(1) That there [was] a genuine and substantial issue of
fact for resolution.

(2) The factual issue [was] not one which may properly
be decided on the basis of official notice of
matters within the expert knowledge of the Agency.

(3) The factual issue [was] capable of being resolved by
available and specifically identified reliable
evidence. A request [would] not be granted on the
basis of mere allegations or denials or general
descriptions of positions and contentions.

(4) Good cause existed for not presenting the material
in question to the Agency for inclusion in the
administrative record. "Good cause" mean(t) either
that the material was not available at the stage of
the RPAR process at which it should have been
presented, or that the material [was] of such a
nature that it [could] only be presented
meaningfully in a trial-type hearing.

(5) The material in question if accepted as valid would
be adequate to justify resolution of the factual
issue in the way sought by the person. A request
[would] be denied to the extent the Administrator
concluded that, even assuming the truth and accuracy
of all of the data and information sought to be
introduced, they [were] insufficient to justify the
factual determination urged.

(6) Resolution of the factual issue in the way
sought...[was] adequate to justify granting some or
all of the relief sought by that person. A request
[would] not be granted to the extent the

86

Administrator concluded that his action would be the
same even if the factual issue were resolved in the
way sought.22
EPA's use of the screening tests, placing the burden of identifying
material issues of fact upon hearing prOponents, closely paralleled the
"summary judgment"23 approach used by FDA in determining whether an
adjudicatory hearing was justified.24 The Agency claimed that its
proposed screening tests would be used to "formalize and define the
standards"25 used by the hearing officer to "structure the course of a
formal proceeding..."26 Yet, in essence, the screening tests would have
the ultimate effect of denying an adjudicatory hearing to an adversely

affected party except in those cases, and for those issues, "for which

trial-type procedures [could] functionally aid the agency."27

C. MDIFICATIONS OF THE RIGHTS OF PUBLIC PARTICIPATION

In the preamble to this proposed rulemaking, the Agency stated that
"the objective of this proposal is to make the Agency's
procedures...more Open, responsive and efficient."28 The Agency further
stated that, "the merger of the RPAR process and the Registration
Standards System would not affect...the opportunities for public
participation in the RPAR process."29 Yet, while espousing the goal of
making the regulatory process more Open, responsive, and efficient, the
EPA was, in reality, describing "a process which [was] more closed than

before."30

87

STANDING

There are two key tests for standing: "injury in fact" and
"whether the particular interest asserted is arguably within the zone of
interests to be protected or regulated by the statute or Constitutional
guarantee in question." If a person has rights recognized by law and
has been injured or threatened with injury by a governmental action then
he has a legal right to challenge that action. As used in the context
of standing to request a hearing in response to a notice of intent to
cancel a registration the EPA defined the term "adversely affected
person" very narrowly. An "adversely affected" person included "9311
persons who want to prevent prOposed actions from becoming effective,
and to litigate with the Agency an unreasonable adverse effects
problem."31 In other words, an adversely affected person is one who has

an economic or property interest in the regulatory outcome of a

 

cancellation decision. "The term does not include persons who believe
that the Agency did not go far enough and who therefore want the Agency
to take actions more restrictive than those"32 which the Agency has
proposed to do.

The proposed regulations would also have severely limited
participation by environmental groups, and others who might be adversely
affected by the notice but do not belong to the class of persons who are
registrants. The Consititutional test for standing is the "injury in

fact" test. In the case of Sierra Club v. Morton33 the Supreme Court

 

held that injury in fact "may reflect 'aesthetic, conservational, and
recreational' as well as economic values." EPA's economic injury
requirement for standing would be contrary to the liberalized law of

standing reflected in the Sierra Club decision. "(T)he prOposal would

 

88

afford this...class of persons an Opportunity to demonstrate to the
Administrator...that an action which he has proposed is inadequate."34
This demonstration would be "based on a showing [by them] that the RPAR
has failed to satisfactorily resolve substantial factual issues which
could have a significant impact on the final regulatory outcome."35
With respect to intervention rights, environmental groups would
only be afforded an Opportunipy to support the Agency's position at a
formal hearing, and "arguing that a section 6(b)(2) hearing [notice of
intent to hold a hearing to determine whether (a pesticide's)
registration should be cancelled or its registration changed] is
necessary to explore their contention that the Agency did not go far
enough."36 The net result Of the Agency's narrow definition of standing
would be the effective elimination of meaningful public participation in
pesticide regulatory decisions and any statutory right they might have
had to fully participate in a Section 6 hearing. This state of affairs
had led one commentor to observe that, '
(dlespite the lip-service repeated throughout the Preamble
to the "objective of...making regulatory decisions...more
Open, responsive, and efficient,"37 in fact this proposal
describes a process which is more closed than before. The
increased public participation mentioned as a goal in the
Preamble3 is upon analysis a triumph of form over
substance. Public participation, other than by
manufacturers and users, is in essence the right to submit
written coments...The proposal eliminates the Opportunity
of the public at large to put the Agency, or the Agency and
pesticide industry and growers, to their proof. Their facts
and value judgements will never be publicly subject to
challenge, except possibly by intervenors in
industry/grower-requested hearings, whose scope will be
strictly limited to issues delineated by the Agency...39
Hence, the proposed rules would have effectively closed members of the
public (other than registrants and agricultural groups) out of the

cancellation/suspension decision process on suSpect pesticides.

89

II THE RIGHT TO A FORMAL ADJUDICATORY HEARING GUARANTEED BY

 

FIFRA AND THE APA WOULD BE ABRIDGED BY THE PROPOSED RULES

 

The prOposed hearing regulations were an attempt to "modernize" the
historical approach used by EPA to reach pesticide
cancellation/suspension decisions. Traditionally, decisions to revoke
or amend a pesticide's use registration(s) were reached after a formal
adjudicatory hearing. By effectively eliminating the access of
registrants and other adversely affected persons to a meaningful formal
hearing, the Agency attempted to elevate the function of an RPAR review
into that of an informal rulemaking. In the Preamble to the proposed
regulations the position of the Agency was "that the RPAR process...with
its multiple opportunities for public input and with its requirements of
carefully articulated decisions based on specifically identified
records--together with the requirements of Part 164 for screening
requests for further proceedings...[would] comprise the requisite
'public hearing' for purposes of judicial review."40 It is thus not
surprizing that the majority Of the coments received by the Agency on
this prOposal addressed the conflict between the EPA's proposed hearing
reforms and the type of hearing FIFRA and the APA require.41

As legal authority for proposed "improvements" of its current Rules
of Practice, the Agency had relied upon the 1975 and 1978 FIFRA
amendments and accompanying Congressional guidance.42 As noted in
Chapter 2, the 1975 and 1978 amendments established certain procedural
requirements for the Administrator to fulfill H123; to making a

determination as to what type of regulatory action to take against a

9O
problem pesticide. These amendments did not, however, alter or
compromise the fundamental role of adjudicatory hearings under FIFRA.

The legal authority for an adjudicatory hearing to be held pursuant
to Section 6 of FIFRA is contained in the provisions of the
Administrative Procedures Act (APA).43 An "adjudication" is defined by
the APA as an "agency process for the formulation of an 219E: "44 "In
every case of adjudication required by statute to be determined on the
record after Opportunity for an agency hearing,”5 the procedures for
formal hearings "in accordance with sections 556 and 557"46 are to be
applied.

Sections 6(b)(1) and 6(b)(2) of FIFRA provide that upon publication
by the Administrator of a notice of intent to cancel or a notice of
intent to hold a hearing, a person "adversely affected" by the notice(s)
may request a hearing. Such a hearing under section 6(d) "shall be
held...for the purpose of receiving evidence relevant and material to
the issues raised by the objections filed by the applicant or other
interested parties..."47 At the end of this hearing the Administrator
"shall issue an gpgerf which "shall be based only on substantial
evidence of record of such hearing..."48

Accordingly, because a hearing conducted under Section 6(b)

requires an order to be determined on the record, the formal
adjudication procedures required by the APA are
applicable.49

Adjudicants (i.e., persons adversely affected by an agency action)
are affored the following procedural rights by the APA:

A party is entitled to present his case or defense by oral
or documentary evidence, to submit rebuttal evidence, and to

conduct such cross-examination as may be required for a full
and true disclosure of the facts.

91

Section 6(d) of FIFRA states that the public hearings held pursuant
to the provisions of section 6(b) of the Act shall be "for the purpose
of receiving evidence relevant and material to the issues raised by the
objections [to an agency action filed by a registrant or other adversely
affected person]."51 The Agency states that "a formal evidentiary
public hearing" under Section 6 would begin with the publication in the

Federal Register of a notice to hold a hearing.‘52 Yet, because of the

 

procedural hurdles contained in the proposed "screening tests" mentioned
earlier, the type of hearing guaranteed by the APA and FIFRA would be
held only when the Agency chose to hold a hearing. This result is
clearly contrary to the affirmative duty placed upon the Agency by law
to hold an adjudicatory hearing which would result in an 9193:.

A substantial body of federal case law affirms the right of
adversely affected persons to a formal adjudicatory hearing contemplated

by Section 6 of FIFRA. In EDF v. Ruckelshaus, Chief Judge Bazelon noted

 

that the statutory scheme of FIFRA contemplated that,

when [the Administrator] reaches the conclusion that there
is a substantial question about the safety of a registered
item, he is obliged to initiate the statutory procedure that
results in...a public hearipg...Public hearings bring the
public into the decision-making process, and create a record
that facilitates judicial review.53

 

In United States v. Florida East Coast Railway CO.,54 the Supreme Court

 

analyzed the procedural significance of statutory language which
required an agency hearing on the record. While the Court did not
construe magical significance to the terminology "on the record" and
"after hearing" it did establish that these words would trigger the
applicability of section 556 of the APA. (Section 556 of the APA, it

will be remembered, prescribes the procedures to be followed by agencies

92

engaged in formal rulemaking and adjudication.) In Seacoast

Anti-Pollution League v. Costle,55 the First Circuit stated that,

 

the FWPCA requires the EPA to afford an opportunity for a
public hearing. We do not believe that an opportunity to
submit documents constitutes a public hearing. Nor do we
believe that the Administrator can comply with the statute
merely by taking some evidence a3 a public hearing and then
taking the rest in written form.5

 

Finally, in Pactra Industries, Inc. v. Consumer Product Safety

Commission57(CPSC), the CPSC attempted to regulate the sale of

 

self-pressurized containers, containing vinyl chloride monomer used as a
prOpellant gas, (classifying them as "banned hazardous substances"), by
.denying requests to hold a formal hearing on this action. CPSC felt
that a hearing was unnecessary since the result of the regulation would
not be changed by a hearing. The Ninth Circuit held that where material
issues of fact were raised by an objecting party they could not be
dismissed by the Commissioniwithout first conducting a formal hearing
and compiling a formal administrative record.

It is clear that the Agency wishes to move away from trial -type to
informal procedures in making regulatory decisions on "problem"
pesticides. Yet, in as much as FIFRA, the APA and legal precedent
contemplate that an "order" be the result of an adjudicatory hearing,
why then did EPA try to amend its current rules Of practice in a way
that would effectively eliminate the opportunities for formal hearings
and public participation? The conclusion one comes to is that the

Agency wished as a matter Of Agency policy to make cancellation

 

decisions through settlement agreements with pesticide registrants. By
making it very difficult, if not impossible, for a registrant to obtain
an agency hearing on a pesticide registration decision and by,

simultaneously, depriving persons adversely affected by a given

93

regulatory decision the right to effectively and fully participate in
agency decisions, the result sought by the agency--to make regulatory
decisions through settlements with the registrants--becomes a
self-fulfilling prOphecy.

The agency clearly recognizes in their current rules of practice
that environmental groups and others have a right to participate fully
in cancellation/suspension hearings.'58 But this right to public
participation in agency actions is a double-edged sword. While it
affords a‘person adversely affected by an agency action his "day in
court" it can also "prevent settlement agreements between registrants
and the Agency that fall short of the group's expectations."59

An environmental group that is a party to a cancellation
proceeding has a statutory right to appeal to a federal
court of appeals any aspects of an Agency's final decision
that it dislikes, and the court must remand any aspects of
the final order not supported by substantial evidence.
Because there is no completed hearing prior to a final
Agency order effectuating a settlement between EPA and a
registrant, there is no record on which the court can base
its review in determining whether substantial evidence
exists to support the Administrator's decision. Therefore,
an "adversely affected" environmental group can have the
order remanded so that it may present arguments under the
statutory criteria for cancelling more uses of the
pesticide. In this way, the environmental group can
exercise a "veto" over settlement.60

 

While the foregoing statement directs its comments specifically to the
veto power environmental groups can exert in any pesticide settlement
decisions it can also be applied to user groups, labor organizations and
consumer groups. The only way to neutralize the veto power of these
potentially adversely affected persons is to deprive them of their right

to fully and effectively participate in pesticide regulatory decisions.

94

The decision of EDF v. Costle61 held that the language of section

 

16(b) of FIFRA (judicial review of agency actions) does not obligate the
agency to hold a hearing responsive to an environmental group's
assertions that the agency imprOperly failed to cancel all unsafe uses
of a carcinogenic pesticide (chlorobenzilate).62 The court in the
chlorobinzilate case focussed on the narrow procedural question of which
federal court was apprOpriate to review a challenge to an Agency
non-cancellation decision. The court of Appeals for the D.C. Circuit
held that:

...persons seeking more stringent regulation may sue in the

district court without first enduring an administrative

hearing; those complaining of regulation as too strict must

first exhaust their administrative remedy of a formal
hearing betore seeki ng iudicial review.

 

 

 

 

In commenting on the import of this decision with respect to the
Agency's proposed regulations,. Thomas O. McGarity (former attorney for
the Office of General Counsel, US EPA) stated that,

(t)he proposed regulations constitute the final step in
effectively closing members of the public other than
registrants and agricultural groups out of the pesticides
cancellation process. The regulations consolidate [the
chlorobenzilate victory] and thereby limit environmental
groups to submitting evidence and arguments in the RPAR
process, supporting EPA's position at the formal hearing,
and arguing that a section 6(b)(2) hearing is necessary to
explore their contention that the agency did not go far
enough. Environmental groups cannot object to the adoption
of one of the novel procedures...The regulations also let
the agency off the hook with respect to deadlines...
Hence, the proposed regulations will govern the dialogue
between EPA and the registrants.64

Given the proposed screening tests which a registrant would have to
satisfy in order to be granted a hearing by the Agency he would perhaps
be more willing to seek other forums in reaching a registration decision

with the Agency.

95

This situation has led the EDF to assert that,
(t)he Agency's prOposal would put enormous discretion in the
hands of EPA personnel in the area of pesticide regulation,
where history clearly shows that there is a trend in

government regulation to support and indeed become captured
by the regulated industry.55

III. THE NEED FOR PUBLIC PARTICIPATION IN PESTICIDE REGULATORY DECISIONS

Pesticide regulatory decisions are typically polycentric issues.
They are Often,
characterized by a large number of possible results and by
the fact that many interests or groups will be affected by
any solution adOpted.6
Where, as in the area of pesticide regulations, the issues are complex
and the costs of making an incorrect decision are unknown and
unknowable, the Agency should actively encourage public participation.
Several important values are served by an agency actively promoting
public participation in its decision-making. One of the most
fundamental values is that of fairness. This is the right of any person
who might be adversely affected by an agency action to have his day in
court. "The 'right to be heard' before government acts adversely to
important private interests is well-established in American
constitutional law."57 As was discussed earlier, both FIFRA and the APA
fully protect this fundamental right.
The decisions weighing the inherent benefits and risks of pesticide
use are highly complex. NO one agency, or member of an agency, is

omniscient. This being true, a second value which can be served by

encouraging full-public participation is that of accuracy.

96

All regulatory decisions are fundamentally political decisions.
Regulatory agencies use scientific/technical information to rationalize
their policy pronouncements. In the DOT case, discussed in Chapter 3,
the Secretary of Agriculture used the lack Of conclusive human health
effects information to support his decision pg£_to stringently regulate
DDT. Less than 18 months later, the new Administrator of the EPA,
William Ruckelshaus, decided to cancel almost all registered uses ‘of
this insecticide. He based his cancellation decision on the same data
base that was considered insufficient, by the Secretary of Agriculture,
to support such a regulatory outcome.

The,
(q)uantitative techniques of decision-making are of great
value in solving many problems...(but) they offer little
prospect of serving as an impartial, irrefutable arbiter of
the conflicts of interest involved in large policy
problems.
Hence, policies must enhance the participation by the broadest spectrum
of experts outside of the agency whose unique knowledge could clarify
the accuracy of regulatory determinations.

Finally, public participation lends balance to regulatory
decision-making. The information upon which a regulatory decision is
based is often incomplete, inadequate or speculative. Thus, determining
the weight to be placed upon one set of information as Opposed to
another is at best a subjective exercise. "Because decisions are left
to regulators with often only delphic congressional guidance, agency

procedures should facilitate broad participation and vigorous debate to V

assure agency understanding of diverse viewpoints."69

10.

11.

12.
13.
14.
15.
16.
17.

97

REFERENCES
7 U.S.C.§136 d(b)(1).
7 U.S. c.5136 d(a)(1).
McGarity, Thomas O. "Substantive Procedural Discretion in
Administrative Resolution of Science Policy Questions:

Regulating Carcinogens in EPA and OSHA", 67 The Georgetown Law
Journal 729, 753 (1979).

 

45 Federal Register, No. 154, Thursday, August 7, 1980, p.
52627.

Ibid, p. 52628. (emphasis added)
Ibid, p. 52628.
7 U.S.C.§§136d(b)(1) and (b)(2)(ii).

CSMA: ,Comments on OPP-60004. "PrOposed Rules Governing
Rebuttable Presumption Against Registration Proceedings; Rules
of Practice Governing Hearings Under Section 6 of FIFRA (45
Fed. Reg. 52628) December 19, 1980 p. 4 (hereinafter, CSMA
comments).

5 U.S.C.§§551(6), 551(7); 554; 556; 557.

EDF Comments on OPP-60004: "Proposed Rules Governing
Rebuttable Presumption Against Registration Proceedings;
PrOposed Rules of Practice Governing Hearings Under Section 6
of the Federal Insecticide, Fungicide, and Rodenticide Act."
December 22, 1980. (hereinafter, EDF comments)

Bauer, "The Study of Policy Formation: An Introduction," in
R. Bauer and K. Gergen, The Study of Policy Formation 1, 9
(1968).

40 CFR 162.11 (1977).
Supra, note 6, at 52630.
Supra, note 3, p. 761.
Supra, note 4, 144.31, at 52665.

Supra, note 6.

"Comments of the National Agricultural Chemicals Association
on the Proposed Rules Governing RPAR Proceedings and Proposed

Rules of Practice Governing Pesticide Hearings" (hereinafter
NACA Comments) 22 December 1980, p. 7.

18.

19.
20.
21.
22.
23.
24.
' 25.
26.
27.
28.
29.
3o.
31.
32.
33.
34.
35.
36.
37.
38.
39.
4o.
41.
42.
43.

98

McGarity, Thomas 0. "Legal Analysis of New Pesticides Hearing
Regulations" (undated; copy on file with author).

7 U.S.C. 136 d(b)(1).
Supra, note 6, at 52638.
Supra, note 6, at 52645.
45 Fed. Reg. No. 154; prOposed 164.52, p. 52667.
41 Fed. Reg. 51706, 51721-51722 (1976).
Supra, note 18, p. iii.
Supra, note 4, at 52645.
Ibid.

 

McGarity, supra, note 3, at 768.

Supra, note 4, at 52628.

lb_i_d_._, at 52628.

EDF Comments, supra, note 10, at 2.

Supra, note 4, at 52639.

121g;

Sierra Club v. Morton, 405 U.S. 727 (1972).

 

Supra, note 4, at 52639.
Ibid.

 

McGarity, supra, note 18, at vi.

Supra, note 28.

Supra, note 29.

EDF Commen.s, supra, note 10, at 2.

Supra, note 4, at 52650.

See, for example, comments of CSMA and NACA on this issue.
1219;, at 52630-52635; 52643.

5 U.S.C. 551; 554; 556; 557.

44.
45.
46.
47.
48.
49.
50.

51.
52.
53.

54.

55.

56.
57.

58.
59.

60.
61.

62.

99

5 U.S.C. 5551(7) emphasis added.

5 U.S.C. §554(c)(2).

5 U.S.C. §554(c)(2).

7 U.S.C. §136dld).

191g;

NACA comments, supra, note 17, fn. 3, at 9.

5 U.S.C.!3556ld) (adjudication begets orders; rulemaking
begets rules).

7 U.S.C.§ 136d(d).
45 Fed. Reg. 52627, 52665 (1980).

EDF v. Ruckelshaus, 439 F. 2d 584, 595 (D.C. Circuit, 1971)
[DDT case].

 

United States v. Florida East Coast Railway CO. 410 U.S. 224,
238, 241 (1973i Tease deciding whether formal rulemaking was
required in a ratemaking proceeding under the Interstate
Commerce Act.]

 

Seacoast Anti-Pollution League v. Costle, 572 F. 2d 872 (lst
Cir, 1978) (meaning, under the Federal Water Pollution Control
Act, of the requirement for an "opportunity for a public
hearing" to be afforded Operators of effluent sources prior to
an effluent limitation).

Ibid., at 879 (emphasis in original).

Pactra Industries v. Consumer Products Safety Comm., 555 F. 2d
677, 684 (1977). [Regulation of vinyl chloride propellents by
CPSC as human carcinogens.]

40 CFR. 164.31 (1980).

McGarity, Thomas 0.: "Death and Transfiguration of Mirex: An
Examination of the Integrity of Settlements Under FIFRA",
Hervard Environmental Law Review 3: 112 (1979), p. 121-122).

Ibid., (footnotes omitted).

EDF v. Costle, NO. 792133 (D.C. Cir., July 17, 1980) 15 ERC
1217. Ichlorobenzilate decision]

Pesticide and Toxic Chemical News, 17 February 1982, p. 19.
[(Statements of Dean Richard A.*Merrill, University of Virginia
Law School).

 

63.
64.
65.
66.

67.

68.

69.

lOO
Supra, note 60, at 1229. (emphasis in original)
Supra, note 18, at vi.
EDF Comments, supra, note 10, at 3.
Boyer, Barry 8.: "Alternatives to Administrative Trial-Type

Hearings for Resolving Complex Scientific, Economic, and
Social Issues", Michigan Law Review, 71:111, 117 (1972).

 

Merrill, Dean Richard A.: "Draft Recommendation 82-8:
Federal Regulation of Cancer-Causing Chemicals", prepared for
*the‘Adhinistrative Conference of the United States, 3/12/82 p.
26.

Bauer, R.: "The Study of Policy Formation: An Introduction";
H1, R). Bauer and K. Gergen, The Study of Policy'Formation; 9
968 .

Supra, note 64, at 27.

Conclusion

 

Public interest/advocacy organizations played a significant part in
the political decisions to regulate problem pesticides. Through the use
of adversarial procedures they shed light on the value judgements and
political trade-Offs inherent in these controversies. Regardless of how
one views the results of the regulatory decisions made on DDT, A/D and
C/H, public interest organizations put pressure upon regulatory agencies
to sUpport their regulatory decisions by a full and complete weighing
of the factual and policy issues raised by the controversy.

While it is readily acknowledged that full public particpation in
formal adjudicatory hearings is time-consuming, the problem cannot be
equitably solved in the manner evisioned by the Agency in this prOposal.
One solution proposed to shorten the length of these hearings, put
forward by a former EPA attorney,

would be the establishment by the Administrator of a maximum
time limit for the hearing in his notice of intention to
cancel or deny registration or to change a classification,
the time to be divided equally between proponents and
Opponents... (This would) force the parties to budget their
time carefully, to present only their best witnesses, and to
discuss only the most important issues, thereby focussing
the attention of the decisionmaker on the strongest
arguments for each side.1

There is no reason why the EPA cannot adOpt this modest prOposal in
its conduct of adjudicatory hearings under FIFRA, if it were truly
committed to increasing the efficiency and accuracy of‘its pesticide
regulatory decisions.

On July 22, 1981, Dr. John Hernandez, Deputy Administrator of the

EPA, in testimony before the U.S. House of Representatives, informed the

Subcommittee on Department Operations, Research and Foreign Agriculture
101

102

that the Agency would not go forward with any amendments to their Rules
of Practice governing hearings pursuant to section 6 of FIFRA.2 No
explanation was given to the committee by Dr. Hernandez for this
decision. Furthermore, a recent committee print of the draft House Bill
to amend FIFRA section 3(c)(3) contains the following provision:

The Administrator shall not by regulation or otherwise

utilize a public interim administrative review process to
abridge entitlement to a public hearing in accordance with
section 6 of this Act.3
Should this provision become law it would effectively prohibit the
Agency from proposing rulemaking like the one discussed in Chapter 4.

As pesticide legislation evolved, from 1910 to the present, a
greater and greater emphasis was placed upon product safety. In the
event that a pesticide, when used as directed, caused unwanted side
effects, provisions were included in FIFRA to cancel or suspend that
pesticide's uses. Since 1972, the FIFRA (actually FEPCA) established
the right of pesticide registrants, applicants, and others who might be
adversely affected by a regulatory decision on a pesticide, or adversely
affected from exposure to a registered pesticide to petition the Agency
to hold a pgpLig hearing on the merits. 1

Public interest organizations (primarily EDF) played an important
role in the cancellation/suspension decisions on carcinogenic,
biOpersistent insectides. The registrations of DDT, aldrin/dieldrin and
chlordane/heptachlor were cancelled through the teamwork of sympathetic
agency attorneys and environmental organization litigants. "There would
have been no cancellations or suspensions without the DOC to act as a
catalyst.”i In the appellate court review of these three pesticide

decisions, EDF established that public interest organizations have a

right to challenge regulatory actions; that notices of intent to cancel

103

a registration shall be issued whenever a substantial question of safety
existed on a given pesticide; that a pesticide registration shall be
suspended whenever the use of that pesticide created an imminent hazard
situation, and, certain principles of carcinogenicity which could be
prospectively applied to regulatory decisions on presumptively
carcinogenic pesticides.

Through its rulemaking proposal, the EPA sought to deny adversely
affected persons their statutory right to a public hearing. More
importantly, the Agency sought to make public participation a
meaningless exercise in the formulation of pesticide regulatory policy.
It is useful to remember that,

[W]hen Congress creates a procedure that gives the public a
role in deciding important questions of public policy, that
procedure may not lightly be sidestepped by
administrators...lhe statutory scheme contemplates that
these questions will be explored in the full light of a
public hearing and not resolved behind the closed doors of
the Secretary. There may well be countervailing factors
that would justify an administrative decision, after
committee consideration and a public hearing, to continue a
registration deSpite a substantial degree of risk, but those
factors cannot justify a refusal to issue the notices that
trigger the administrative process...Public hearings bring
the public into the decision making process, and create a
record that facilitates judicial review. If hearings are
held only after the Secretary [and now the Administrator] is
convinced beyond a doubt that cancellation is necessary,
then they will be held too seldom and too late in the
process to serve either of those functions effectively.5

104

REFERENCES

Spector, Phillip>l_.: "Regulation of Pesticides by the
Environmental Protection Agency", Ecology Law Quarterly, Vol.
5:233, 247 (1976).

 

Hernandez, Dr. John W.: Deputy Administrator, U.S. EPA;
Statement Before the Subcommittee on Operations, Research and
Foreign Agriculture, Committee on Agriculture, House of
Representatives, July 22, 1981, p. 9.

H.R. 5203, 97th Congress, lst Session: Bill to Amend the
Federal Insecticide, Fungicide and Rodenticide Act, December
14, 1981.

Statement of William Butler: "Pesticides: Three EPA
Attorneys Quit and Hoist a Warning Flag", Science, Vol.
191:1155, 1156; (1976).

EDF v. Ruckelshaus, 439 F.2d 584, 594-595 (D.C. Cir. 1971)
[fOOtnotes ommitted].

 

APPENDIX 1

105

APPENDIX 11

Major Events in the History of Pest Control

 

9213 15:311.
400,000,000 B.C. First Land Plants
350,000,000 B.C. First Insects
250,000 B.C. Appearance of Homo sepiens
12,000 B.C. First records of insects in human
society
8,000 B.C. Beginnings of agriculture
4,000 B.C. Silkworm culture in China
2,500 B.C. First records of insecticides
1,500 B.C. First descripton of insect pests
9&18.C. First description of cultural

controls (burning)

300 AA). First record of use of biological
controls (predatory ants used in
.citrus orchards in China)

1650-1780 Burgeoning of insect descriptions
(after Linnaeus) and biological
discoveries in the Renaissance

1732 Farmers first begin to grow crOps in
rows to facilitate weed removal

1750-1880 Agricultural revolution in Europe

early 18005 Appearance of first books and papers

devoted entirely to pest control

18405 Potato blight in Ireland (no
controls available to curb disaster)

1870-1890 Grape phylloxera and powdery mildew
controlled in French wine country
(introduction of Bordeaux mixture;
Paris Green; use of resistant root
stalks and grafting)

1880 First commercial pesticide spraying
machine

106

1888

18905

1896

1899-1909

1901

1910

1912
1915

1921

1929

19305

1939

1940

19405

First major biological control agent
importation success (Vedalia beetle
imported to U.S. from Australia for
control of cottony cushion scale in
citrus in California)

Introduction of lead arsenate for
insect control

Recognition of arthropods as vectors
of human disease

Development of strains of cotton,
cowpeas, and watermelon resistant to
Fusarium wilt (first breeding

 

program tOr pathogen resistance)

First successful biological control
of a weed (lantana in Hawaii)

The Insecticide Act of 1910 (first
U.S. pesticide statute)

U.S. Plant Quarantine Act

Control of disease-vectoring
mosquitoes allowed completion of
Panama Canal

First aircraft pesticide Spray
Operation (in Ohio, for Catalpa
Sphinx)

First area-wide eradication of an
insect pest (Mediterranean fruit
fly)

Introduction of synthetic organic
compounds for plant pathogen control

Recognition of insecticidal
prOperties of DDT

Use of milky disease to control
Japanese beetle (first sucessful use
of pathogen for insect control)

Organophosphates developed in
Germany; Carbamates in Switzerland

107

1942 First quccessful breeding program
for insect pest resistance in crop
plants (introduction of wheat strain
resistant to Hessian fly)

1944 First hormone-based herbicide
(2,4-0)

1945/1946 DDT marketed as "miracle"
insecticide

1946 First report of insect resistance to
DDT (housefly in Sweden)

1947 The original Federal Insecticide,
Fungicide, and Rodenticide Act
enacted

19505, 19605 a 19705 Widespread development of resistance

to DDT and other pesticides

19505 First applications of systems
analysis to crap pest control

1959 Introduction of concepts of economic
thresholds, economic injury levels
and integrated control

 

1960 ' First insect sex pheromone isolated,
identified and synthesized (gypsy
moth)

1962 Publication Of Silent Spring

1970 EPA created--given control over
pesticide regulation from USDA

1972 Banning of DDT

1972 FIFRA amended and renamed the

Federal Environmental Pesticide
Control Act (FEPCA)

 

108

REFERENCE FOR APPENDIX

Flint, Mary Louise and Robert van den Bosch: A Source
Book on Integrated Pest Mapegement, DHEW Publication, 1980.

 

 

   

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