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UNITED STATES v. VITA FOOD PRODUCTS OF ILLINOIS

February 14, 1973

UNITED STATES OF AMERICA, PLAINTIFF,
v.
VITA FOOD PRODUCTS OF ILLINOIS, INC., A CORPORATION, AND LAWRENCE T. SCHWEIG, AN INDIVIDUAL, DEFENDANTS.



The opinion of the court was delivered by: Parsons, District Judge.

MEMORANDUM OPINION AND ORDER

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 the corporation.

The government contends that the defendants violate 21 U.S.C. § 331(a) in that they introduce and cause to be introduced and deliver and cause to be delivered for introduction into interstate commerce smoked chubs which are adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C) and that defendants violate 21 U.S.C. § 331(k) in that they cause chubs, while held for sale after shipment in interstate commerce and containing the above-named chemical substances, to be prepared, packed and distributed as smoked chubs, which acts result in the smoked chubs being adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C).

A hearing was held pursuant to 21 U.S.C. § 335 on September 16, 1969 regarding the interstate shipment of smoked chubs which were alleged to contain the aforementioned chemical substances in excess of the amounts of 5 parts per million of DDT or derivatives or which contained dieldrin in excess of .3 ppm.

I

In effect, the government's theory is that the chubs involved herein are adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C) because DDT and dieldrin are "food additives" under the Act and second since "their use and intended use are not in conformity with a regulation or exemption" they are "unsafe" as a matter of law under the terms of 21 U.S.C. § 348(a).

Defendants' position is "that any traces of DDT and dieldrin in its smoked fish are not "food additives within the Act", and that the government's mode of procedure "seriously perverts the elaborate statutory scheme established by Congress to ensure the safety of food and food additives and that defendants are not now and have not in the past sold any `adulterated' smoked fish."

Defendants contend that the government has tried to establish adulteration as a matter of law because it is unable to establish adulteration as a matter of fact and in so doing has ignored the statute.

21 U.S.C. § 342(a)(1) states as follows:

  "A food shall be deemed 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 health; or (2)(A)
  if it bears or contains any added poisonous or added
  deleterious substance (other than one which is (i) a
  pesticide chemical in or on a raw agricultural
  commodity; (ii) a food additive; (iii) a color
  additive; or (iv) a new animal drug) which is unsafe
  within the meaning of Section 346 of this Title, or
  (B) if it is a raw agricultural commodity and it
  bears or contains a pesticide chemical which is
  unsafe

  within the meaning of Section 346(a) of this title,
  or (C) if it is, or it bears or contains, any food
  additive which is unsafe within the meaning of
  Section 348 of this title. . . ."

21 U.S.C. § 348(a) states as follows:

  "A food additive shall, with respect to any
  particular use or intended use of such additives, be
  deemed to be unsafe for the purposes of the
  application of clause (2)(C) of section 342(a) of
  this title, unless —
  (1) it and its use or intended use conform to the
  terms of an exemption which is in effect pursuant to
  subsection (i) of this section; or (2) there is in
  effect, and its use or intended use are in conformity
  with, a regulation issued under the section
  prescribing the conditions under which such additive
  may be safely used. While such a regulation relating
  to a food additive is in effect, a food shall not, by
  reason of bearing or containing such an additive in
  accordance with the regulation, be considered
  adulterated within the meaning of clause (1) of
  section 342(a) of this title."

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; 1185-86).

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:

  "Residues of DDT (including derivatives) in fish
  shipped in interstate commerce will be limited to 5
  parts per million (ppm) under an interim guideline
  announced today by the Food and Drug Administration.
  "The interim limit has been established primarily
  because of high residues of DDT and its derivatives
  found in coho salmon from Lake Michigan.
  "This guideline is intended to protect the public
  from excessive levels of DDT in fish while a full
  scientific review is completed," Food and Drug
  Commissioner Herbert L. Ley, Jr., M.D. explained "It
  also gives the fishing industry a specific standard.
  Fish carrying residues higher than 5 ppm will be
  subject to seizure.
  "The F.D.A. has asked the National Academy of
  Sciences — National Research Council to nominate a
  panel of experts to carry out the review of DDT
  residues in fish. The 5 ppm interim limit may be
  changed as the result of that study, Dr. Ley
  said."

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:

  "Plaintiff concedes that this guideline is neither a
  `regulation' which the Act empowers it to issue, nor
  any other species of administrative rule recognized
  by any relevant or pleaded statute. This guideline is
  not published in the Code of Federal Regulations, nor
  apparently in any other published compilation of
  administrative rules.
  "Since there is no statutory authority to issue such
  an interim enforcement guideline, it follows that
  defendants' violation of law, if any, must be of the
  statute itself, in this case The Food, Drug and
  Cosmetic Act."

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 ...


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