The opinion of the court was delivered by: Parsons, District Judge.
The proceedings upon which the following opinion is rendered
are based upon a Complaint for Injunction filed by the United
States of America under Section 302(a) of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. § 332(a), (hereinafter referred to as
the Act), which invests this Court with jurisdiction to enjoin
and restrain violations of Section 301 of the Act, 21 U.S.C. § 331.
Defendant, Vita Food Products of Illinois, Inc., is an Illinois
corporation. Defendant, Lawrence T. Schweig, is vice-president of
DDT is a chemical pesticide which has been used since the early
1940's to control mosquitoes and other pests. Recently, the use
of DDT has been reduced by approximately 80% in the United States
(tr. 219) and as of January 1, 1972, due to an order of the
Environmental Protection Agency, the use of DDT will be almost
eliminated. DDT and its derivatives are found in virtually all
living tissue. Studies show that these concentrations (8-10 parts
per million) in man (tr. 180) are decreasing (tr. 863-66;
Dieldrin is a far more mysterious substance than DDT although
like DDT it finds its way into certain organisms. The most that
can be said of dieldrin at this juncture is that its effect has
not been fully demonstrated.
On April 22, 1969, a "guideline" characterizing 5 ppm as the
maximum amount of DDT permissible in fish shipped in interstate
commerce was issued in the form of a press release by the F.D.A.
In part the release stated:
In ruling on the statutory basis for the F.D.A.'s authority to
issue its interim enforcement guideline the Court in United
States v. City Smoked Fish Co., et al. (E.D.Mich., Memo.Op.
33669, pg. 6, 1970) said:
The Court therein found such violation of the statute. However,
I find myself in disagreement with that decision
and instead find that DDT and dieldrin are not "food additives"
within the meaning of the Food, Drug and Cosmetic Act of 1939.
I have come to this conclusion after a careful analysis of the
statute, the 1959 "Food Additives Amendment" and its legislative
history and purpose.
I find it necessary to quote at this point from that
"* * * This bill, if enacted, will require the
processor who wants to add a new and unproven
additive to accept the responsibility now voluntarily
borne by all responsible food processors of first
proving it to be safe for ingestion by human beings.
"* * *
"The second flaw in existing law which has proved
detrimental to consumers, the processors, and to our
national economy and which this bill seeks to remove
is a provision which has inadvertently served to
unnecessarily proscribe the use of additives that
could enable the housewife to safely keep food
longer, the processor to make it more tasteful and
appetizing, and the Nation to make use of advances in
technology calculated to increase and improve our
food supplies. Your committee agrees with the Food
and Drug Administration that existing law should be
changed to permit the use of such additives as our
technological scientists may produce and which may
benefit our people and our economy when the proposed
usages of such additives are in amounts accepted by
the Food and Drug Administration as safe." Senate
Report No. 2422, 85th Cong., 2d Sess., 3 U.S.Code
Cong. & Admin. News, p. 5301 (1958).
Thus, the purpose of the Amendment was two-pronged; to permit
the use of food additives in safe quantities but only after tests
for safety conducted before the food in which those additives are
used is introduced into commerce.
Section 348 provides an elaborate procedure for evaluating the
safety of "food additives". Thus, 21 U.S.C. § 348(b)(1) reads as
"Petition for regulation prescribing conditions of
safe use; contents; description of production methods
and controls; samples; notice of regulation. . . ."
and contains elaborate procedures that must be adhered to by any
person who intends to use a food additive and details the
conditions under which such an additive may be safely used.
It is uncontroverted that defendants herein do not actually
"add" DDT or dieldrin to its product. The chemicals in question
are introduced into the chubs by the environment. In no way have
the defendants been accused of nor do they deliberately use the
named substances in connection with the preparation of their
The Committee reports which accompany the Food Additives
Amendment deal with three different categories of "food
"The legislation covers substances which are added
intentionally to food. These additives are generally
referred to as `intentional additives.'
"The legislation also covers substances which may
reasonably be expected to become a component of any
food or to affect the characteristics of any food.
These substances are generally referred to as
"The principal examples of both intentional and
incidental additives are substances intended for use
in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or
holding food." Senate Rep. No. 2422.
Therefore, it may be seen that neither the "intentional" nor
"incidental" category of "food additive" is applicable. It is not
an "intentional" additive because there is no allegation that the
defendants nor for that matter any other person or corporation
add the named chemical substances to the chubs.
Nor may they be considered "incidental" additives because
Congress clearly enunciated that only those substances
deliberately used in the course of the manufacturing or
distribution process would be within that category. It is
indisputable that any DDT or dieldrin in defendants' chubs result
from unintentional circumstances which occur prior to the fish
The third category of "additives" are "accidental" and the
Senate Report states as follows in respect to such additives:
"On the other hand, substances which may accidentally
get into a food, as for example, paints or cleaning
solutions used in food processing plants, are not
covered by the legislation. These additives are
generally referred to as `accidental additives',
since these substances if properly used may not
reasonably be expected to become a component of a
food or otherwise to affect the characteristics of a
food. If accidental additives do get into food, the
provisions of the Food, Drug, and Cosmetic Act
dealing with poisonous and deleterious substances
would be applicable."
I find myself in agreement with defendants that if, indeed, DDT
and dieldrin traces found in fish are to be considered
"additives" in any sense, they must clearly be considered
"accidental" ones and as such not a "food additive" under the
Act. Thus, I am in disagreement with the government's contention
that "as components of the defendants' chub, residues of DDT and
dieldrin are incidental food additives governed by the food
additive provisions of the Act." (Govt.'s post-tr. brief, pg.
One of the government's witnesses Dr. Frederick Coulston stated
that DDT's presence in the chubs is `accidental' (tr. 245). Dr.
Coulston testified as follows:
Q. Do you know, sir, from your studies and through
your group, what the best thinking is as to how the
DDT got there? (Into fish that are swimming in
A. Well, of course nobody rightly knows exactly how
it got there. We can only suppose that the use of
the DDT in spraying for environmental control of
insects or in use on crops in the soil, eventually
washed down into the rivers and then into the
lakes * * *" (tr. 207).
Thus, the chemical substances DDT and dieldrin are not ones
intended for use in "producing, manufacturing, packing,
processing, transporting, or holding food." Congress was most
explicit in its delineation of what constitutes an "intentional"
or "incidental" additive.
21 U.S.C. § 321(s) defines "food additive" and expressly
"(1) a pesticide chemical in or on a raw agricultural
"(2) a pesticide chemical to the extent that it is
intended for use or is used in the production,
storage, or transportation of any raw agricultural
commodity * * *."
A case on point is one cited by defendant, United States v.
Bodine Produce Co., 206 F. Supp. 201, 210 (D.C.Ariz. 1962.) in
which the Court stated that the DDT found in lettuce was not a
"* * * By the Food Additive Amendment in 1958 * * *
Congress tackled the problems of food additives in
processed foods in depth. It drew a sharp line
between the Food Additives Amendment and the
Pesticide Chemicals Amendment. Thus in the definition
of "food additive" it excluded pesticide chemicals in
or on raw agricultural commodities. * * *"
In Environmental Defense Fund v. United States, 138
U.S.App.D.C. 391, 428 F.2d 1083 (1970), the Court stated:
"* * * the statute (21 U.S.C. § 321(s) explicitly
excludes pesticide chemicals from the definition of
the terms `food additive' and `color additive'."
The government has attached as Ex. D to its Trial Memorandum
in U.S. v. City Smoked Fish, supra, in which the Court found:
"It further appears that DDT found in raw chubs is a
pesticide chemical and not a food additive within the
meaning of the Act. However, the Court concludes that
DDT found in smoked chubs is a `food additive', since
the chubs are no longer in their raw or natural state
as required by the Act."
I cannot agree. 21 U.S.C. § 342(a) states that a "pesticide
chemical" remains a "pesticide chemical" within the meaning of
the Act even after the "raw agricultural commodity has been
subjected to processing such as canning, cooking, freezing,
dehydrating or milling."
For the above stated reasons, I find that any traces of DDT or
dieldrin found in defendants' chubs cannot be labeled a `food
additive' within the meaning of the Food, Drug and Cosmetic Act
The next issue to be resolved is that of whether or not the
chubs in question fall within the purview of
21 U.S.C. § 342(a)(1), supra, a portion of which states:
"A food shall be deemed to be adulterated — If it
bears or contains any poisonous or deleterious
substance which may render it injurious to health;
but in case the substance is not an added substance
such food shall not be considered adulterated under
this clause if the quantity of such substance in such
food does not ordinarily render it injurious to
The government has alleged as follows:
"It should be noted that smoked chubs containing
residues of DDT, its derivatives or dieldrin in
excess of the enforcement guidelines need not be
proven injurious to health to be adulterated under
the Act. In a long line of cases, the federal courts
have held that foods may be adulterated regardless of
whether they are injurious to health, unless the
particular statutory definition of adulteration
expressly requires the Government to prove such
injury (citing cases). Since
21 U.S.C. § 342(a)(2)(C) does not require such proof, no injury
to health need be shown to establish the adulteration
alleged in this case." (Govt's Tr. Memo., p. 20).
However, having found that 21 U.S.C. § 342(a)(2)(C) is not
applicable, I find that injury to health must be shown in order
for the government to prevail. The testimony on this issue was
diverse and interesting but in the final analysis not as
illuminating nor as definitive as might have been hoped.
Dr. Frederick Coulston, a toxicologist and one of the
government's witnesses testified as to rumors that DDT might be
"But its the uncertainty. I can only state that I
know of no harm to man, human beings, from DDT even
in larger amounts than five parts * * *." (Tr. 218).
Professor Rolf Hartung, another government witness testified as
"There is at least one suggestive study by Poland who
looked again at a series of pesticide formulators and
reported that those people who had received 20 times
the normal background level of pesticides did exhibit
a slight increase in the rate in which they would
metabolize these drugs.
"Now this does not in any way imply safety either.
The reason it doesn't imply harmfulness is because
the effects are very subtle and we cannot make an
easy judgment as to whether this is permanently
hurting a person or not. I am dubious that it would
personally hurt a person." (Tr. 297).
A short time later in the trial Professor Hartung stated:
"If we want to look for any evidence whatever as to
what might be happening for man at normal types or
to normal types of dosage, we are very hard put."
Dr. William Deichmann, an eminent toxicologist, testified in
behalf of the defendant and stated during the trial that counsel
for the government had telephoned him and:
"* * * told me that the Vita Food Company had been
selling smoked fish which contained 7 or 8 parts per
million DDT, and whether I would speak for Food and
Drug Administration, since the permissible limit in
smoked fish is 5 parts per million, and the primary
issue was whether I could make the statement that the
ingestion of smoked fish containing 7 or 8 parts per
million is injurious to health.
"Q. And what did you say, sir?
"A. I told Mr. Raubicheck (government counsel) that
if it is a question of whether the food company is
guilty of exceeding the concentration, if that is
the question, that I must agree that 7 or 8 is more
than 5, and on that basis I would say they would be
guilty, but if it is a question of health hazard of a
concentration of 8 parts per million, that I couldn't
support that, and for that reason I declined to
testify for Food and Drug, and I wrote to Mr.
Raubicheck a letter to that effect." (Tr.
When asked his opinion as to the chronic toxicity of residues
of DDT in human beings Dr. Deichmann responded:
"I could refer you to the studies that have been done
where the concentrations, the retention rates in
human beings, have been very much higher than those
in the general population without any effect that the
investigators and physicians tried to find and did
not find." (Tr. 807).
In response to the question of whether he knew of any disease
in humans attributable to DDT the witness replied:
"I have introduced this word on two occasions
(DDT-itis), and I made the statement that there is no
record of any DDT-itis in this country or any other
country. . . ." (Tr. 807).
Again Dr. Deichmann testified:
"Nowhere in the world does this compound, and I am
referring to DDT, present an `imminent hazard' to
public health — ." (Tr. 852).
Thus, I cannot on the basis of the evidence tendered during the
course of this trial unequivocably state that DDT is a known
health hazard to man.
A great portion of the trial revolves around the issue of the
reliability of the test methodology used by the government to
prove that the samples of Vita's chubs involved herein contained
DDT concentrates in excess of 5 ppm. The government's test method
is referred to as the "AOAC" method. Although I shall not go into
a detailed analysis of the testing procedures I should like to
note the following information that was gleaned from the trial
No method of testing has been proven to be absolutely reliable.
Certain discrepancies that were raised during trial and in
defendant's post-trial brief have led me to conclude that the
AOAC method is capable of distinguishing between concentrations
of DDT in the area of 4 to 9 ppm. Thus, there is always the
possibility of a margin of error and I must hold that the AOAC
method, when left to be followed by testers provided by food
processors in all cases and utilized by government testers only
in spot checking on the continuous batch upon batch testing to be
performed by the food processors, is incapable of that degree of
accuracy which ought to exist to support a court judgment
enjoining a food processor from proceeding on in the industry.
Since September 1971, the American Meat Institute Laboratory
(AMI) has been hired by Vita to analyze its chubs for pesticides,
using the AOAC method. The AMI Laboratory also analyzes each of
the samples which formed the foundation
for the case herein. Its analysis showed substantially lower
results than did the comparable analysis performed by the FDA
chemists. Four of the seven AMI analyses showed readings below 5
ppm and the highest of those above 5 ppm read 5.35. There are
numerous other examples of differences between the various
methods of testing. Differences in results tended to reflect
differences between individual chemists performing the tests.
The concept "absolute reliability", like the phrases
"unimpeachable preciseness" and "perfect certainty", is repugnant
to the scientific mind. The most that should be looked for is
"sufficient reliability" — reliability to a degree sufficient for
the purpose to be served. The purpose to be served here is not
served when the acknowledged degree of exactness has a
coefficient of error of plus or minus 25%, and when various tests
of the same samples with the same procedures performed by equally
qualified persons result in readings varying over a range of one
From all the relevant data one fact stands out. It is that
science has not developed a system which is sufficiently
reliable. The AOAC's method is not sufficiently reliable for me
to find by the greater weight of the evidence and as a
controlling fact that the chubs sampled by FDA in April 1972
contained DDT concentrations in excess of 5 ppm.
There is in this case uncontradicted evidence tending to show
that the level of Lake Michigan chubs generally is less than 5
ppm. Mr. Bernard Lorant, a chemist, testified that based upon all
of the test results in evidence (FDA's AMI's, NMFS, and those of
WARF) (Def. Ex. 29) the incidence of DDT and its analogs in Lake
Michigan chub are at or below 5 ppm. (Tr. 1202-03).
In summary, I find that 21 U.S.C. § 342(a)(2)(C) is not
applicable since DDT, derivatives of DDT and dieldrin found in
Vita's smoked chubs are not "food additives" under the Act. I
find that DDT, derivatives of DDT and dieldrin as found in Vita's
smoked chubs are not a known health hazard within the meaning of
21 U.S.C. § 342(a)(1). I find that the test method to be used by
processors of smoked chub is not sufficiently precise for a
finding of fact that the chubs sampled in April 1972 contained
DDT concentrations in excess of 5 ppm.
It should be made crystal clear that these findings do not open
the gate to an area of abandonment of concern on the part of
processors of food. Neither do they restrain the Food and Drug
Administration from pursuing a severe program of monitoring
processors of smoked fish in its effort to keep out of interstate
commerce food that constitutes a known health hazard. I have been
presented in this case just one matter and my findings are
technical ones. By the greater weight of the evidence and by the
applicable law the allegations of the complaint against these
defendants have not been sustained.
This Memorandum Opinion shall constitute my findings of fact
and conclusions of law.
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