Full opinion text
MEMORANDUM AND DECISION KELLY, District Judge. This is a statutory seizure action filed by the United States of America, plaintiff, pursuant to Section 673 of the Meat Inspection Act. This relates to the boned beef and offal of a lot of 273 animals, which were implanted with an illegal drug. The drug in question is diethylstilbestrol (DES), a drug allegedly known to cause cancer and other toxic effects, and which drug was implanted in the cattle (steers) after the last legal implant date as established by the Food and Drug Administration. The implants of DES were still present and were detected at the time of slaughter of the cattle and the carcasses and offal were officially held by the United States Department of Agriculture. Jarboe-Lackey Feedlots, Inc. is the owner of the beef in question and because this is an in rem action against the food, this party is not a defendant but only a claimant, intervening in behalf of the seized beef. The government alleges that the meat and offal of these animals is adulterated pursuant to 21 U.S.C. § 601(mXl), M2A and M3. In this, if the food is adulterated in any of these ways, the law requires that it be condemned and disposed of by destruction or sale, pursuant to order of this Court in conformance with the Act and the laws of the jurisdiction in which the beef was sold. Initially the matter came to the Court’s attention by way of the government’s motion for summary judgment and claimant’s motion for judgment on the pleadings. Each provided considerable affidavits and other authoritative material accompanied with briefs and arguments. Upon full review and reflection, it was apparent to the Court that considerable disparity of the material facts and law existed and the government’s motion was overruled. The thrust of claimant’s motion was based on the Secretary of Agriculture’s alleged unlawful retention of the seized meat and offal in excess of a 20-day statutory period prior to the filing of the seizure action and in violation of 21 U.S.C. § 672. The timely relevancy of this procedure was not clear to the Court and as a consequence the matter was taken under advisement, pending further evidence and argument. In light of the findings of this Court, as hereinafter set forth, further consideration of defendant’s motion appears redundant and is now overruled. Having reviewed the Court’s finding as it relates to the plaintiff’s motion for summary judgment, the parties were advised that as a finder of fact, the Court, on the strength of affidavits and other exhibits at hand, probably had sufficient factual data to adduce significant findings of fact and reach an ultimate decision. The parties agreed to this format, subject to the privilege to amend, polish, or otherwise “embellish” their respective data and positions. This proposal was acceptable, assuming then, that each would respond and comply within the week, and the matter would then be ready for final argument and submission. It developed that as each side pondered their respective position, and the Court surmises the strength or weaknesses of the other, each began to add and detract, significantly, and to the point that ultimately — neither would agree to the other’s contentions or proffers, each finding fault with the other’s case, and at which time the Court resolved the impasse by scheduling the matter for full evidentiary hearing. In retrospect, save the learning process garnered in the course of those proceedings, a full evidentiary hearing probably should have been anticipated and scheduled from the outset, but which, ironically, has changed nothing as it relates to the Court’s ultimate decision. It has only served to enhance it! As it relates to trial preparation, an orderly discovery calendar was set, the Court available for status conferences and a pretrial conference, at which time certain admissions, stipulations and ultimate orders were entered. In the final analysis, as the case commenced to trial, both sides were fully prepared, each at liberty to exhaust every facet of this most provocative issue. In the course of three weeks’ time, the very nature of the issues in controversy, as developed and expounded by both parties, exposed the trial court to the intricacies of varied scientific and technical discipline. In part;, it has engaged the expertise and learning of outstanding and dedicated authorities, both private and public, both sides. For the Court, a layman in the truest sense, it has been a learning process throughout. It has required an appreciation and perception in such fields as the sensitivity of chromatography; infra-red spectro-photometry; animal studies of varied character and its relationship to man; biostatistics, i. e., risk assessment or extrapolation of data as it might affect the consuming public; biochemistry, including the course of estrogenic hormones and the protein receptor principle; epidemiology; toxicology, including molecular breakdown of chemicals involved; pharmacology; the functions of certain organs, i. e., livers, kidneys, and the significance thereof; and, of course, cancer, other effects and the implications of DES. While these and others, as brought to the Court’s attention, are complex subjects and probably to the experts only the “tip” was explored, thanks to their most candid and objective presentations, hopefully, the thrust of their respective presentations were perceived and retained. The Court is frank to acknowledge, that while all of the foregoing appeared complicated and foreign to the Court’s experience from the outset, a most serious problem in the perception of testimony and its relationship to the “real world,” as so often addressed by claimant’s counsel, was an appreciation of the metric system, i. e., conversion of grams, milligrams, nanograms, to something common to the Court’s own experience. The record is replete with the Court’s inquiry, i. e., request to convert into factors readily understood. In the scientific world the quantum of the remnants of the drug in question is measured against the weight of the beef in question in parts per billion (ppb). In this, one nanogram per gram equals one ppb. A grasp of the significance of such findings, in the interest of the Court’s realistic perspective, has been exasperating. For example, understanding a resume of the following evidence: The government, in part, contends that a finding of 6.25 ppb has been established in certain mice studies to affect a carcinogenic response. As this converts to the human’s average consumption of beef, it represents 0.002 ppb or 0.002 mcg/kg (Claimant’s ZZ). In the real world, this converts to a consumption of approximately 18,940 pounds of beef per day. Such an example is only intended to express the complicated nature of this case, but, it is to say such an ultimate finding is also an example of the very kind of factual findings and conclusions as a consequence with which the Court has been required to deal. Simply stated, to adopt claimant’s view — a quest of a few grains in a massive field of sand. The Court concurs, the significance of this quantum being the ultimate issue. In addition, the mass of exhibits, including considerable authoritative references, articles, not the least of which include reams of the Federal Register, have been read and digested. While only referenced in a cursory way, considerable portions of the “Congressional Record,” tracing the history and intent of Congress as it relates to the act in question, has been reviewed. While not necessarily helpful, it has satisfied the Court’s attempt to more fully appreciate the propriety of that which is at hand. To capsule: The Federal Meat Inspection Act was enacted to provide additional legislation which in the view of Congress was “urgently needed for truly adequate protection of consumers, legitimate operators in the affected industries and others associated therewith. . . . The object of the proposed bill is to eliminate numerous opportunities now present to defraud consumers and endanger public health.” Letter from the Department of Agriculture requesting the legislation, U.S.Code and Administrative News, p. 2209 (1967). Likewise 21 U.S.C. § 602, Congressional Statements of Findings, states, “It is essential in the public interest that the health and welfare of consumers be protected.” Seizure and condemnation is a means to protect the public from adulterated food. The Secretary is not required to bring a condemnation action when adulteration is only suspected; 21 U.S.C. § 676(b) states, “Nothing in this chapter shall be construed as requiring a Secretary to report for prosecution or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice of warning.” Indeed, the rationale for the reduced governmental burden of proof in this seizure action is the purpose of suppression of a public wrong. See C. C. Co. v. United States, 147 F.2d 820, 824 (5th Cir. 1945). Each witness, the substance of his testimony, the thrust of cross-examination, both sides, the witness’s demeanor, his qualifications, experience, his ultimate reliability, believability, has been weighed and perceived. In the recent past, the entire transcript of approximately 4,000 pages has been reviewed by the Court. This review has been most helpful, not only for the purpose of an accurate reference to the evidence recited in this opinion, but also to confirm the accuracy of trial notes, including reflection, i. e., initial impressions through the course of hearing. While this review is obviously required in the interest of accuracy, it has also changed nothing insofar as trial findings are concerned. Indeed, the Court’s ultimate decision comes only after a full contemplation and hopefully perception and appreciation of each of the foregoing and other disciplines, objectively applied to the evidence at hand. Upon completion of full hearing, the government renewed its motion for judgment, which was overruled. Now counsel have most vigorously argued their respective causes. Some additional briefs, suggested findings of fact and conclusions of law are submitted. In this, the quality of trial counsel, their work products, exhibited throughout the course of these proceedings, was commendable and deserving of comment. In the absence of their own intense preparation, learned articulation and presentation of evidence and witnesses, and their patience, this case, in the hands of less able counsel, might still be ongoing. These traits were noted and appreciated by this trial judge. In addition, and iii furtherance of clarity as it relates to the Court’s ultimate decision, some essential rudiments are recited, each having been perceived as fact and none ignored: DES is one of a class of chemicals known as stilbenes. Stilbenes are not produced metabolically by animals; they do, however, produce effects similar to those produced by endogenous estrogens. It is considered a synthetic estrogen and was first synthesized in 1938 and approved for use in cattle feed in November, 1954. Its use is as a growth promotant, having considerable economic benefit in the livestock business. A new drug application for DES implants in cattle was issued under the Food, Drug and Cosmetic Act in December, 1955. In this regard, approximately 15 milligrams of DES are implanted subcutaneously into the ear of the steer as a pellet, which dissolves over time, and ostensibly provides DES continuously in the animal’s circulation. DES is a carcinogen in animals. In 1958, the Act was amended by addition of the Dulaney Anti-Cancer Clause, codified at 21 U.S.C. 360b. The amendment required the FDA to refuse to approve use of a drug if the Secretary found that “such drug induces cancer when ingested by man or animal.” DES is such a drug. In 1962, Congress enacted an exception to the Dulaney Anti-Cancer Clause, known as the DES Exception. This exception is codified at 28 U.S.C. 360b(d)(l)(h). In June, 1972, the FDA made an attempt to withdraw approval for the use of DES, the agency action being reversed because of procedural defects. Hess and Clark Div. of Rhodia, Inc. v. Food & Drug Adm., 495 F.2d 975 (D.C.Cir.1974). This decision details the administrative history with regard to DES until 1974. It was not until 1976 that the FDA again took steps to revoke the approval of the use of DES in animals. Notice of hearing was issued in November, 1976. On July 6, 1979, the FDA issued a final rule revoking the animal drug regulations which had permitted the use of DES in cattle as both an animal feed and as a subcutaneous implant. 44 FR 393837. At this time, the FDA issued notice that it was revoking the NADA’s applicable to DES for both feed and implants. 44 FR 39618-39619. These notices were to become effective on July 13, 1979, as to the manufacture and shipment. Animal use of DES drugs was to be discontinued effective July 20, 1979. Following protests from DES users and what would appear to be an obvious in-house political in-play, the effective date of the DES ban was postponed until August 3, 1979, and again postponed until November 1, 1979. 44 FR 42679, 45618, 45764. It was subsequent to this date that the claimant, and probably inadvertently, caused the cattle in question to have been implanted (Government 51). As relates to the ban, the Court further notes that during the course of this proceeding the manufacturer’s second appeal was decided in Rhone-Poulenc, Inc., Hess & Clark Div. v. Food & Drug Adm., 636 F.2d 750 (D.C.Cir.1980). The thrust of this decision, of course, finalizes for all time the FDA ban. Of interest to the Court is the fact that the appellate court addressed itself to the sufficiency of fact adduced in the administrative hearing engaging different ground rules for admissibility of evidence and a different burden of proof. Some focus is given to this circumstance now, as the gravity of that decision has been repeatedly urged upon the Court, suggesting that the ultimate findings of the FDA commissioner and now of the appellate court be adopted here as final authority. In light of these contentions, and fully aware of the implications suggested by the FDA findings, it is appropriate to assure the parties that the Court has not, and an understanding of this best premises and contrasts this opinion. The thrust of the commissioner’s findings are geared to certain conclusions that the drug is “not shown to be safe.” For reasons as hereinafter reviewed, this is not the test required by this Court. To explain, in the commissioner’s review of testimony, laboratory findings, and the scientific literature in an attempt to discover a “no effect level” for DES, i. e., a dosage level at which DES would not cause cancer or other harmful effects in human beings, he concluded that no such level had been demonstrated and that DES is, therefore, “not shown to be safe since there is no proof that small amounts of it are not harmful.” 44 FR 54, 873-81. The appellate court concludes that: “By proceeding in this matter the commissioner has met his ‘initial burden of coming forward with some evidence of the relationship between the residue and safety. . . . ’ Hess & Clark, supra [161 U.S.App.D.C.], at 413, 495 F.2d 993. He is relying not only on the fact that larger amounts of DES are harmful, but upon laboratory studies which conclude that it is impossible to determine a safe level of DES in human beings. This evidence is sufficient to shift the burden of showing the safety of DES to the manufacturers, and as urged here to suffice the plaintiff’s case. Id.” It is this Court’s view that, as opposed to whatever procedures and burdens are imposed in a governmental administrative hearing, here, in a court of law, where, indeed the ultimate “laboratory,” in the quest for truth, time-honored requisites are followed. They include the admissibility of competent evidence within the meaning of the rules of evidence. Specifically, as it relates to the perception of factual scientific issues, conclusions are geared to “meaningful projections from reliable data.” Monsanto Co. v. Kennedy, 613 F.2d 947, 949, 952 (D.C.Cir.1979), Food, Drug & Cosmetic Law Rep. 38.010. Consistent with this view, this Court has not given serious review to evidence emanating from rank speculation. Of paramount import, the concept of due process, in the Court’s view, imposes the burden of persuasion on the proponent, here the government, and this burden does not shift. Conversely, the proponent’s cause is not met on the establishment of certain “negative” findings from which “positive” conclusions are to be drawn. The government’s case must be reasonably positive and convincing to meet its burden, however modest. It is this Court’s appraisal of the matter before the commissioner, which incidentally involved the presentation of many of the witnesses before this Court, that had he listened personally and as intently as this judge did, and the burden was similar, his decision probably would have been a different one. His, being administrative, involved the presentation of witnesses most of whom submitted their testimony in written form. Some, quite material in this Court’s view, were not invited to participate. Others, considered most material in this case, were not cross-examined. In other words, while the entire record before the FDA is most informative and enlightening to this Court, it does not serve to tilt this factfinder. Lastly, and again in the Court’s grasp for perspective, particularly as relates to DES and its implications with cancer and other effects, some solace was given to the oft-repeated idiom of the Grecian, Paraselsus, who first clarified “the dose determines the poison.” This truth suggests in part that all chemicals are poisonous and it is the quantum which makes the difference. It follows that DES is a chemical and as a consequence, as any other chemical, is poisonous. Its ultimate toxic effect necessarily depends upon the quantum of its dosage and use. In this, this thesis has been accepted from the outset as the evidence has been weighed. In other words, while the government would suggest that the mere presence of DES in this or any beef is of significance, it has been received awaiting the government’s persuasion that the quantum involved in the case at hand would hurt anyone. As a realist, the Court now appreciates that the consuming public, i. e., approximately 200 million people, have daily and continuously consumed beef of DES implanted cattle for a period of approximately 25 years without a single report of a carcinogenic effect. Why this experience cannot serve as an inadvertent but most persuasive test escapes the Court. Again, as the evidence is reviewed, its significance will come to bear, the effect of the ban precludes henceforth the legal use of DES. This edict is a fact of life and not in issue here. We deal here, therefore, with the matter of “adulteration, if any, of the beef in question, which represents approximately 150,000 pounds of meat,” ostensibly distributed in normal commercial channels. All of the experts seemingly agree that as it relates to whatever conclusions are drawn as to the adulteration of beef, it is to assume that this consuming public will consume approximately two ounces per day continuously for the remaining portion of their respective lives. The relationship of such a test to the beef in question again escapes the Court. The Meat Inspection Act and the Government’s Burden As a prelude to the resume of factual findings and ultimate conclusions, some discussion of the Act in question and this Court’s understanding of the requisite burden of proof is necessary. In this, the requisite portions of the Act in question are as follows: a. Any carcass, part of a carcass, meat or meat food product of cattle, sheep, swine, goats, horses, mules or other equines, or any dead, dying, disabled, or diseased cattle, sheep, swine, goat, or equine, that is being transported in commerce ... and that ... is capable of use as human food and is adulterated or misbranded ... shall be liable to be proceeded against and seized and condemned, at any time, on a libel of information in any United States district court.... (21 U.S.C. § 673). % # )k $ The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances: (1) 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 article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; (2) (A) if it bears or contains (by reason of administration of any substance to the live animal or otherwise) any added poisonous or added deleterious substance . . . which may, in the judgment of the Secretary, make such article unfit for human food; ****** (3) if it contains in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food. [21 U.S.C. § 601(m)(l), (m)(2)(A), & (m)(3).] Again, in the interest of clarity, each definition will be treated separately; however, it is obvious and probably conceded by both parties, that the focus of this case was addressed to (m)(l), and only after the tests applicable to this section are weighed will discussion follow with regard to the others. In this, as it relates to Section 601(m)(l), the standard for defining “may be injurious to health” as used in the Food and Drug Act is established in United States v. Lexington Mill & E. Co., 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658 (1914). The Lexington Mill libel action charged that flour had been treated by an Alsop process by which nitrogen peroxide gas was mixed with air and brought in contact with flour, causing its adulteration. Adulteration was claimed in that the flour contained a poisonous or other added deleterious ingredient which might render the flour injurious to health. A jury returned a verdict in favor of the government, the 8th Circuit reversed, and the Supreme Court affirmed the reversal. The evidence concerning the presence of poisonous substance, nitrogen, and the possibility of its being injurious to health, was conflicting. The government attempted to show the poison present in a proportion of 1.8 ppm and that it would be injurious to those who used the flour in bread or other forms. On the other hand, respondent showed the process did not add any poisonous or deleterious ingredient to the flour which could in any manner render it injurious to the health of a consumer. The court instructed the jury that it need only find that a substance had been added to the flour. “It is the character — not the quantity, of the added substance, if any, which is to determine this case.” 232 U.S. at 408, 34 S.Ct. at 339. The Supreme Court found that the instruction constituted prejudicial error because it permitted the statute to be read without the final and qualifying words; the instruction failed to state the legal standard that the contaminating material must render the article injurious to health before the statute was violated. The Court reasoned that if Congress had intended to make presence of nitrogen a violation per se, it would not have legislated the additional health-affecting requirement. The purpose of Congress was to prevent injury to the public health. As against adulteration, the statute is intended to protect from possible injury through addition of articles which are poisonous or deleterious and which may render such articles injurious to health. As to the burden placed upon the government, the Court rejected a standard requiring proof that the allegedly adulterated food contains substances which will affect the public health. In order to prevail, the Act imposes on the government the burden of establishing, . .. that the added poisonous or deleterious substances must be such as may render such article injurious to health. The word ‘may’ is here used in its ordinary and usual signification, there being nothing to show the intention of Congress to affix to it any other meaning. (232 U.S. at 411, 34 S.Ct. at 340) (Emphasis added). The Court quoted from congressional records which indicate that poison depends both on the quantity and the combination of ingredients. Per se adulteration was not intended. “May be injurious to health” is to be interpreted in its natural and ordinary sense. Where there is no- possibility of harm under a reasonable consideration of the facts, the food is not within the ban of the statute. Numerous decisions subsequent to Lexington Mill have affirmed that the phrase “may be injurious to health” is one of a reasonable consideration of the facts. The definition of adulteration in the Federal Meat Inspection Act, 21 U.S.C. § 601(m)(l), is identical to that included in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 342(a)(1). Both sections state adulteration includes food which “bears or contains any poisonous or deleterious substance which may render it injurious to health.” There have been no decisions under the Federal Meat Inspection Act interpreting this definition of adulteration. Because of the identical wording and the similar legislative purpose of both Acts, case law interpreting adulteration under this definition in the Food, Drug and Cosmetic Act should be determinative of the interpretation applicable under the Meat Inspection Act. In Millet, Pit & Seed Co., Inc. v. U. S., 436 F.Supp. 84 (E.D.Tenn.1977), two suits, a civil rights action and a condemnation case, were consolidated. The government seized cases of apricot kernels alleging, inter alia, that they were subject to condemnation as an adulterated food within the meaning of 21 U.S.C. § 342(a)(1). However, the alleged deleterious substance was not an added substance but was one which occurred naturally. Therefore, the applicable standard was not “may be injurious to health;” it was the less stringent statutory standard that the food could not be considered adulterated if the quantity of such substance in the food does not ordinarily render it injurious to health. 21 U.S.C. § 342(a)(1). The Court readily found that the poisonous substance did not render the apricot kernels ordinarily injurious to health. In so doing, it noted that Lexington Mill, in quoting from the legislative history of the 1906 Act, recognized that poisonousness rests upon both the quantity and the combination of the substance. Many substances, if consumed in excess, will produce some adverse effect. Despite government evidence of the possibility of harm from ingestion of excessive quantities of apricot kernels, the Court concluded that under the ordinary uses and ordinary conditions standards for naturally occurring substances, the government failed to carry its enhanced burden of proof. A substance which occurs naturally and is also added to the environment by man, i. e., mercury, is considered in United States v. Anderson Seafoods, Inc., 447 F.Supp. 1151 (N.D.Fla.1978), aff’d 622 F.2d 157 (5th Cir. 1980). The United States claimed that swordfish were adulterated within the meaning of 21 U.S.C. § 342(a)(1). Before deciding which standard of health injuriousness would be applicable to the seized swordfish, the Court first addressed the question whether the mercury occurred naturally or was an added substance. The trial court determined that because man had significantly affected the total level of mercury in swordfish, the allegedly adulterated fish fell within the first aspect of the definition for added deleterious substances. The Fifth Circuit, however, did not address the trial court’s application of the “may be injurious to health standard.” The district court interpreted the word “may” to connote a “reasonable possibility.” It does not mean that a food may be prohibited absent absolute certainty that no one under the most extreme circumstances could be harmed. Nothing in the Act or legislative history suggests that Congress intended to proscribe a food simply because it was physically possible for someone to consume enough of it to harm oneself. The Supreme Court has taken notice that a person could be harmed by ingesting a certain level of table salt, or even water. United States v. Anderson Seafoods, Inc., 447 F.Supp. at 1155. Reliance is placed on Lexington Mill, 232 U.S. at 399, 34 S.Ct. at 337; Berger v. United States, 200 F.2d 818 (8th Cir. 1952); and Wood v. United States, 286 F. 84 (7th Cir. 1923). The Court concluded that swordfish containing 1.0 ppm or less of mercury “pose no reasonable possibility of injury to anyone’s health, [therefore] they cannot be deemed adulterous within the meaning of Section 342(a)(1),” United States v. Anderson Seafoods, Inc., 447 F.Supp. at 1159. Three distinct standards for determining injuriousness to health under 21 U.S.C. § 342(a)(1) have been discussed by the courts: (1) injuriousness per se from the presence of a poison in however small an amount, rejected by Lexington Mill; (2) a reasonable possibility of harm for added deleterious or poisonous substances, defined by Lexington Mill; and (3) injurious under ordinary uses and under ordinary conditions for naturally occurring substances. The parties seemingly concur with the foregoing resume as the basic guidelines, the effect of which shapes the decision of this case. Not surprising, there is little concurrence as to how it should be applied. Indeed, the Court’s enigma has dealt with the weighing of that which is possible. Such a test, unlike any other known in the Court’s experience, offends his sense of due process. Surely, in a traditional way, only the test of that which is probable, i. e., likely, can the truth be found. Possibilities, embodying rank speculation, in any other setting are not admissible, let alone left as the basis of decision. Actually, the Court has prayerfully given more time and attention in his deliberation of the interpretation of this test than the evidence itself. Accordingly, No. (2), i. e., that which is reasonably possible, is adopted as the standard for which the government’s burden is tested. In this, the Court has received this case, weighed it and decided it, hopefully with a sense of common sense, the effect of which an objective and fair decision is reached. Simply stated, emphasis to that which is reasonable is the catalyst which breaks the impasse and determines this case. With this understood, and contrary to repeated urgings and inuendoes urged by the government, it is not to say in a close case, i. e., the evidence relatively equal, or even remotely possible, in the interest of consumer safety, the government wins. It is to say that in a court of law, whatever the test, in the event of the proponent’s failure to persuade — failure to tip the scales — failure to meet its burden — it loses! In the final analysis, this is the only reasonable test known to this or any court — and applies here. Conversely, it is also to say that the mere presence of DES in this or any beef does not automatically render it adulterated. If Congress so intended, it could have said so! In lieu of such an adamant proclamation, that body seemingly has contented itself to leave such decision to a trial court, and in the exercise of due process, as the Court perceives it, extended to both parties, now each have had their day. Sequence of Evidence and the Court’s Commentary, with Findings A review of the evidence in this case logically commences with the involvement of the Jarboe-Lackey Feedlot as represented here through Mr. Jud Lackey, its president. In November, 1978, his company had received a quantity of DES implants for use in his rather large cattle operation. By November, 1979, and notwithstanding his awareness of the ban, principally in light of the fact that he had requested an extension for the purpose of using up the remaining portions of DES on hand, it is obvious that his hands did implant cattle with the compound. It would appear that on April 17, 1980, of the total number of steers sent to MBPXL for slaughter, at least 197 head of 273 head of cattle were so implanted. Dr. Gerald Rousseau, DVM, the supervisory medical officer of MBPXL, an employee of the U. S. Department of Agriculture, on April 17, 1980, observed the DES implanted pellets in the ears of certain slaughtered cattle and confirmed them to be those of the Jarboe-Lackey Company. He was advised to retain the cattle and to take samples, i. e., seven ears. In the course of events, he segregated the carcasses and followed through the process ultimately resulting in the 2156 boxes of boned beef, including 193 boxes of liver. While probably not relevant to this sequence of events, puzzling circumstances are noted as they relate to the government’s policy as of that point in time: As of November 1, 1979, the DES ban was in effect; however, if cattle so implanted prior to October 31 were presented for slaughter on April 17, 1980, such a condition was considered legal (I & 69). In addition, as of that point in time the government authorized an explant program, the effect of which required the cattle operator to remove the implanted ears 120 days in advance of slaughter, the program recognized as the “authorized distribution of adulterated beef” (P). Seemingly 0.6 ppt in muscle was considered safe as opposed to whatever quantum it then contended was within the cavities of the Lackey beef. Typically speaking, the government’s monitor program is that certain samples of liver are from time to time forwarded to certain laboratories under government contract. In light of the sensitivity of the equipment used to register a presence of DES, if any, findings under .5 parts per billion in liver are not considered significant. In light of this, it is obvious that even today, and henceforth, unless the government has specifically focused on commercial beef to the extent that they have “leveled” on Mr. Lackey’s beef, considerable quantities of DES implanted beef pass into commerce — all with the government’s acquiescence. Much of the foregoing is emphasized and repeated throughout the course of this case, perhaps for other reasons, but, it is to remark now that, on hearing this, the Court’s reaction to the fervor generated by most persuasive government counsel, as relates to the adulterated nature of the beef in question, was dampered from the outset. These interesting anomalies remained on the conscience of the Court throughout the course of this matter. Witness Myers, a chemist of the U. S. Food and Drug Administration, received six of the ear samples and submitted them to gas chromatography to confirm the presence of DES, and which was accomplished, the findings running from remnants of approximately 4.5 mg to 6.6 mg, 15 mg maximum having been initially implanted. In this regard, while considerable contest follows as to whether any DES is lodged in the beef, it was apparent from the outset that in light of Myers’ finding, the presence of some residue seemed obvious, but probably legally insignificant. It is of interest to note here, however, that only upon commencement of this case and hearing witness Myers, does it become apparent to the Court, that at the time of the filing of the matter, only the claimant had actually tested the edible portion of the beef for the presence of DES in same. While the Court was unable to perceive all of the significant evidence at the time of the motion for summary judgment, it is now apparent to the Court that the same should have been promptly overruled. Ironically, it developed that the results of the claimant’s tests were not admitted as being unreliable (Scofield). In this, inasmuch as the claimant had offered the Scofield findings in the course of its motion to dismiss and for the purpose of suggesting its minute quantity, the Court was at liberty to note the same, notwithstanding the formal inadmissibility. In the course of events, and shortly prior to the commencement of trial, the government did cause certain specimens of the livers and kidneys to be tested. The ultimate results of these tests engaged a most extensive focus of the parties’ and the Court’s attention. Commencing October 9, 1980, certain samples of liver and kidney from the Lackey beef were forwarded to the Chemistry Division of the U. S. Department of Agriculture for analysis by Mr. Hsu and Dr. M. Hoffman, chemist. Simply stated, the test results by gas chromatography and mass spectrometry purported to reflect the detection of no DES in any of the liver samples, however, eight of fifteen kidney samples reflected presumptive positives from .02 to .15 ppb. Two kidney samples were analyzed below .01 ppb and DES was not detected in the remaining five kidney samples. As a layman perceives it, the gas chromatography procedure is intended to determine án approximate quantum of the compound and the mass spectrometry procedure confirms its presence (14). These quantums serve to base the remaining data of the government’s case and its gravamen became of considerable significance. In the course of witness Hsu’s testimony, the parties respectively expressed considerable interest not only in the manner the gas chromatography procedure was conducted but the significance of the graphs from which the conclusions were reached. Notwithstanding considerable cross-examination as to the propriety of the ultimate findings, no objections from the claimant were suggested as to the admissibility and these instruments were understandably admitted. A review of the record reflects the Court’s initial confidence in the reliability of witness Hsu and Hoffman’s testimony. Indeed, some rather firm remarks to claimant’s counsel, in his intense effort to test the propriety of these findings, are noted. In the Court’s defense, and hopefully to any layman at this point in time, there was then no real basis for question of the obviously qualified witnesses. Only as the case developed did it appear that each was less than candid. As it relates to Exhibits 57, 58 and 59, it is not to say that the trial court did not retain some quandary as to the witnesses’ interpretations of these graphs. To a layman, they surely fail to objectively demonstrate with any precision the substance of what the witness purports to show. It is simply to say that at the time of their respective testimony, the Court was without a basis to appreciate its significance. By example, the reliance upon the technician’s observations of certain “peaks” ostensibly are found in these graphs, and which are intended to reveal the precise instance the presence of DES and its quantum is reflected. In most instances, as closely as the Court attempted to follow this evidence, no peaks were noted. Hopefully, such an observation does not offend the scientific world, but it is submitted here to express in part the Court’s quandary in this most technical field. To further explain the Court’s present reservations as to the reliability of witness Hsu’s interpretations, witness Scofield, also an organic chemist and residue supervisor at the Analytical Bio Chemistry Laboratory, and who had similarly tested for the claimant and incidentally one who routinely tests for the government, out of hand disclaims the reliability of these most important exhibits. In addition, Dr. Robert Sieck, an eminently qualified analytical chemist, and who it appears is the co-author and assisted in the development of the method used by witness Hsu, having reviewed the exhibits at hand, most persuasively disclaimed their reliability. In light of this circumstance and in rebuttal of the claimant’s case, it was clarified' that witness Hsu has, for the purpose of these tests, relied upon a certain hepta-fluorobutyryl (HFBT) derivative, and without attempting to relate the technical distinction, suggests that the effect is that it enhances the sensitivity of the Hsu test approximately nine times over. This interesting entree is introduced by Dr. Hoffman in his rebuttal testimony, corroborated by Dr. Jack Watson, a rebuttal witness. At this juncture, it may be said that the thrust of the observations of these witnesses, i. e., Hoffman and Watson, need not be in doubt. It is to suggest that the significance of this entree was not brought to bear in the case in chief. In this regard, claimant’s counsel fairly asked the witnesses if the GLC procedures had been modified (Hoffman, ¶ 121), (Hsu, ¶ 47), and this was denied. Government counsel repeatedly assured the Court that this procedure was not different than that routinely administered by the government in its tests for the presence of DES in beef. Claimant’s counsel did not pursue this principally after admonitions from the Court. It now develops that neither witness was experienced with this derivative or its use here, Hsu revealing no experience, and Hoffman none prior to June of 1980, the samples in question taken for trial being the principal substance of his. Indeed, given another day, it is to say that claimant’s counsel was denied fair cross-examination of either of these witnesses, and the present thrust of the observations and findings of witnesses Hoffman and Hsu is in doubt. For the purpose of this opinion, giving rise to full and fair cross-examination, at which time the foregoing revelations should have been brought forward through either witness Hsu or Hoffman, (Ex. 57, 58, 59), and the ultimate findings probably would not have been admitted in the absence of a fair foundation, save for “what it’s worth.” At this point in time, the exhibits are before the Court and as to their propriety, it is to say that the Court places more credence for the presence of DES in beef in the fact that the animals were implanted than in witness Hsu’s findings, and to this extent it is acknowledged that the presence of DES is noted. It is not to say that such findings are of any legal significance. In this connection, for the purpose of the ultimate decision, the thrust of which addresses itself to the significance of the quantum, if any, is that, at most .02 ppb are noted in some of the kidneys, the maximum remotely suggested by the evidence. With the Court’s reservations as noted, the government’s remaining case is as follows. As indicated, Dr. M. Hoffman was called principally to focus his expertise as it relates to the mass spectrometry findings. These differ from the former, the intended purpose being to establish the presence, not necessarily the quantum, of DES. A rebuttal witness, Dr. Watson, did volunteer that he could ascertain the quantum of DES from these graphs. The Court perceives the latter to be akin to those of fingerprints, which is hardly an available tool to ascertain the weight of a given person, certainly if measured in grams. The suggestion of Dr. Watson is discarded out of hand. Considerable focus was given to the thrust of witness Hoffman’s findings and his readings of the graphs from his tests. Again, his findings were intensely focused and controverted by witness Sieck, the propriety rejected by the latter. This witness happened to have assisted in the development of the Donoho Method ostensibly relied upon by the government. His presence and testimony struck the Court as entirely reliable. Inasmuch as the Court has concluded that DES is probably present in the kidneys to the extent noted, corroboration of its presence was not necessarily required. By way of comment as to these exhibits, however, it is certainly to say that interpretation, by reason of its complexity, remains for the experts. Indeed, if the GLC findings presented problems of perception, these graphic readings are more difficult. The trial court listened intently to all sides and studied the exhibits as closely as practicable. In light of the controversy that obviously exists between the eminent witnesses called in this case, they are disregarded as being of any scientific assistance to the Court. Simply stated, a review of these exhibits suggests that the experts can read into them about what they want to read, the Court perceiving nothing and is totally helpless, if, they were intended to be of benefit for either side. The government then moved to confirm the presence of DES in the muscle or meat portion of the beef. This witness was Dr. Peter Aschbacher, a research physiologist, U.S. Department of Agriculture, who is conversant with radioisotope techniques and techniques of infrared spectroscopy and the chemical interpretation of infrared spectra. His research has developed a process for detection and quantitation of remnants of DES in tissue and excreta. His experience here is with regard to the 14/C DES experiments. The objectives of these studies were to place 14/C label DES implants into the ears of steers and then determine the excretion patterns of 14/C, the distribution of the 14/C within the body, and the extent that the 14/C in various tissues and excreta was associated with the DES molecule. On the strength of a review of the evidence at hand, he opined that residues of DES were probably in the edible portions of the beef in question. Frankly, as the witness came forward, the Court had assumed that this, gentleman probably was one of the government’s most significant witnesses. Indeed, the thrust of the government’s case at the time of the motion for summary judgment would suggest this. The cross-examination of this witness, however, and particularly his remarks as shown in Exhibit M (Aschbacher, p. 81), served to negate his significance, the presence of DES in the meat portion, if any, or of any significance by his standard, remaining in doubt. Certainly if, at best, .02 ppb are found in the kidney, his thesis will not stand. While the sequence of witnesses were not presented as capsuled, the government next focused attention on those witnesses who would purportedly relate the significance of the quantum of DES in the beef in question as it may affect the public’s safety. Inasmuch as each scientific witness in part relates his testimony to a certain study conducted by Dr. George H. Gass in June, 1964, i. e., Carcinogenic Dose-Response Curve to Oral Diethyistilbestrol, and his apparent findings are of significance in this case, some focus is given now as to these findings. This was an animal test wherein C3H female, C3H male, and strain A castrate male mice were divided into test groups that were given feed containing DES at the following levels: 0 ppb, 6.25 ppb, 12.5 ppb, 25 ppb, 50 ppb, 100 ppb, 500 ppb and 1,000 ppb. The test group ranged from 50 to 78 mice. The three control groups ranged from 115 to 136 mice. The government suggests a statistical significant incidence of mammary carcinoma was observed in the group of C3H female mice receiving the lowest dosage (6.25 ppb). The C3H female mice receiving 12.5 ppb and 25 ppb did not show a statistically significant increase in tumors over controls (both of these treated groups showed tumor in 43.3% of the mice as opposed to 33% in the controls .25 ppb group). There is no question that the C3H female mice fed 50, 500 and 1,000 ppb DES developed mammary gland cancer and the evidence of cancer in the treated groups increased with the increasing levels of exposure. The test groups of C3H male and castrated male mice were less sensitive. Some tumors developed in animals fed 12.5 ppb but statistical significance was not clearly apparent below 6.25 ppb of exposure. The obvious points of contention are that the results of this study do not show that low levels of DES cause cancer and do show that low levels of DES do not cause cancer, i. e., that there is a “no effect” level. This portion of the case commences with the government witnesses presupposing that the Gass report conclusively establishes the absence of any “no effect” level below 6.25 ppb, and as the Court perceives it, assumes therefore that consumption of DES-implanted beef of any quantum renders it adulterated. As the Court perceives it, an ultimate decision as to the propriety of these studies is critical. Dr. Kenny Crump is a biostatistician and consultant for the government. His forte is that of risk assessment, i. e., the estimate of that which is possible, engaging what is considered the technique of extrapolation. This is an obvious and apparently acceptable aid in the decision making bodies of the Food and Drug Administration. While its reliability under the normal test of evidence, and which would exclude speculation, the witness, without interruption or objection, testified in depth as to his procedures and findings. The thrust of his testimony, accepting certain statistical data from the Gass study, is correlated to humans, 6.25 representing .002 parts per billion in the meat. He further references other articles (G-ll) relating the average food intake of Americans at about 24 pounds a week, representing about 2.3 pounds of which is beef. If it is to assume that the average DES residue in beef muscle might be .2 ppb, the average dose of DES to Americans from DES residues in beef muscle is approximately .02 ppb. As previously indicated and as the evidence further develops, such a conclusion cannot conform to the evidence at hand. His thesis further assumes that the population of this country at risk is 200,000,000 people, and given a lifetime exposure to DES in meats at .02 ppb, would result in approximately 15,000 extra cancers as derived from the most sensitive mice strain as evidenced by the Gass study. Dr. Larry S. Andrews is of the Division of Toxicology, Bureau of Foods, and has been called upon to evaluate practical conclusions as to the safety of the chemical in question. He appreciates the Gass findings and others. It would appear the substance of his testimony is that while amounts of DES in the tissue from animals in question are small and likely to be much less in beef muscle, these amounts have never been shown to be safe in food for human consumption. Because DES does cause cancer and birth defects in people and mutations in experimental animals, he does not believe that these amounts of DES are safe for people to eat. As a consequence, he has concluded that consumption of the beef in question may be injurious to health. Dr. Robert J. Condon is a mathematical statistician with the Bureau of Veterinary Medicine of the Food and Drug Administration. He is presently on detail to the Office of the Commissioner, Associate Commissioner for Health Affairs, Scientific Liaison and Intelligence Staff. His duties at the FDA primarily involve the evaluation of biological test data on the effects of toxic substances and estimating the degree of risk associated with the consumption by humans of toxic substances. Indeed, since 1971 he has been involved in the evaluation of the toxicity and the degree of risk associated with consumption of residues of DES-implanted beef. The witness proceeded to summarize the thrust of the government’s case. He is a fully well-intentioned and partisan witness. It should be noted that he was called as rebuttal, principally to address himself to Gass’s testimony (as hereinafter noted), disagreeing entirely with the conclusions of Gass. He uses Exhibit 49 to illustrate his point and which the Court perceives is wholly out of proportion as it relates to the rebuttal testimony; the Court was finally convinced that the witness is all things to all people in this case, in that he was called upon to touch upon just about every iota of evidence offered by claimant. He, of course, addressed himself to Gass, Jukes, Jensen and Upson, all of whom are hereafter discussed. The Court’s notes indicate that when the witness had finally completed his testimony, it was thought he had lost his objectivity and the thrust of his principal testimony in support of Crump was in doubt. In addition, Dr. Joseph Rodrick was called as a rebuttal witness in the interest of confirming Crump and Doull (hereinafter noted) and to offset Jukes, Jensen and Gass. His experience in DES is limited; he takes time to attempt to explain the toxicological difference between DES and estradiol (Ex. 29). He confirms that if we are dealing with .02 ppb in the kidneys and extrapolated to .002 parts in the meat, this involves consumption in the aggregate of 150,000 pounds of beef. The Court’s impression was that this witness, again, is another catch-all type who was brought back to touch base as opposed to every witness offered by the claimant. He was partisan personified. Dr. William Hobson, the Director of Primate Research Institute at New Mexico State University, was called. His field is reproductive biology, that is, the reproductive processes in animals. He discusses the hormone system, which controls muturation, i. e., development early in the fetal life through puberty. He uses primates in his research, being the closest available animal model of man. He was interested in the effect of estrogen on the reproductive development in primates and DES is a known potent estrogen. Normally, he presents DES to the animals in a daily dose, depending on the age of the animal. He is interested particularly in two hormones which control reproductive development, luteinizing hormone (LH) and follicle-stipulating hormone (FSH). He is looking for a “no observed effect” level, being a level at which he fails to find a statistically significant effect as opposed to a “no effect” level, which is one wherein he is reasonably certain actually had no effect. He reviews Exhibit 53, being a graph of follicle-stimulating hormone in infant rhesus monkeys, which describes levels in the serum of infant rhesus monkeys treated from the day of birth with 50 micrograms of DES per kilogram of body weight per day (50 mcg/kg). In his judgment, administration of DES completely suppressed levels of follicle-stimulating hormones when compared with similarly treated controls. Exhibit 56 is intended to explain conversion from DES dosages at this level to levels of DES in parts per trillion in human food. Considering the weight of the monkeys, i. e., 2.2 pounds and DES dosage for that kilogram of weight, this converts to 3.0 ppb. This further includes a two-thousand fold safety factor, i. e., the dosage for the monkeys would be two-thousand fold higher than 50 mcg/kg, i. e., 6,000 ppb. As relates to meat intake, a factor of 500 grams consumption per day is considered. This converts to a pound and two ounces of meat, and assumes a human weighs approximately 130 pounds. Simply stated, if the witness’s tests were converted to beef with a comparable amount of DES in it, it converts to 6,000 ppb DES. While the witness proceeded, the Court pondered his own responsibility to apply that which is reasonably possible, and notwithstanding the serious effects known from excessive consumption of the compound, retained reservations as to realistic applications here. Turning to the effect of DES on LH levels in infants from the date of birth, which engages a lower dosage level, i. e., 60 ppb, an elevation in the luteinizing hormone in both sexes of the monkeys, particularly females, was noted, i. e., sex skin swelling. In summary, the lowest level fed, being 6 ppb without a safety factor, is interpreted as follows: A All right. This calculation of what we would predict would be a safe level of human exposure in the meat consumed is based on the assumption that we are starting at a level at which we did not observe an effect. Now, I am not confident at this time that we have reached such a level. The lowest level we have fed is 0.05 micrograms per kilograms, and it appears to me that we’re beginning to observe an effect. THE COURT: Which is six parts per billion? A Which is six parts per billion without the safety factor. Yes, sir. Dr. John Doull, a professor of pharmacology and toxicology and who directs the Poison Control Center at Kansas University Medical Center, was next called. His specialty is in the field of toxicology, i. e., the study of adverse effects of drugs. He has worked with Dr. Crump and acknowledges risk assessment as a valid function in the field of toxicology. He states that toxicology does include extrapolation from animal results in that it is both a science, i. e., method of accumulating data, and an art. In predicting from his data base, the toxicologist’s mechanism to indicate his uncertainty is his “safety factor.” The size of the safety factor is dependent on his confidence in his data base in relation to predicting for other species. To characterize toxicity, he needs to know the adverse effects that might result and the dose response data. He is aware of enough data to have no doubt that DES is a carcinogen. In addition, DES has teratogenic effects in humans and animals. The existing toxicology data base for DES did not enable the calculation of a safe level in human food and he takes care to explain the procedures he would require. On the strength of his studies, not necessarily his own testing, and accepting the Gass studies, it was his conclusion that there are no “effect” levels on this material and one cannot go on the safety factor route. In other words, there is a “no observed” effect level. It was obvious that the government was focusing considerable attention to the witness in the interest of bringing to bear ultimate conclusions relating to its burden. In this regard, as a preface to his ultimate findings, the witness acknowledges that the existing toxicological data base for DES does not enable a calculation of a safe level in human food. This is not to say that the witness believes that there is not, simply that it has not been established. Perhaps as a contradiction, he further acknowledges that science uses a lot of carcinogens in medicine and wherein the benefit outweighs the risk. Certainly, as the compound exposes humans to carcinogens in a non-medical situation, there is a cardinal rule that you do not expose people to a noxious agent unless you have the full spectrum of information from animal studies. He discusses synergism as the enhancement of response getting a greater effect by adding effects of two agents. While DES has some estrogenic characteristics, it is not the same as estrogen produced in the body. In the final analysis, and while he would probably eat the meat in question, he would hesitate to advise someone else to eat it, his ultimate opinion being that consumption of the beef in question would be harmful or injurious. This gentlemen was, indeed, the government’s most impressive witness. In this connection, the Court interjected several of his own questions in the interest of clarity. A review of some best reveals the state of the government’s case at that point in time: Q And your testimony as to the risk and the potential hazard to the consuming public is based, again, upon that factor and not upon the marketing of this 154,000 pounds of muscle being held in this court? You have made no risk assessment with respect to the consuming public for a one time consumption of this product, have you, sir? A True, because it’s my understanding that, you know, what you are asking me as a toxicologist is to speak to the risk associated with the long term low level exposure. Now, if you are asking for an assessment of the toxicological risk following one acute exposure, I would have a different toxicological evaluation. THE COURT: What would that be, Doctor? A I beg your pardon? THE COURT: What would that be? A At the levels that we are talking about, it would be far less — I probably wouldn’t be terribly concerned about that kind of exposure. I guess I would have to hedge on that a little bit