can be reached. As President Reagan said in his veto statement on H.R. 3963 of the last Congress, we "share the widespread public desire for new legislation on tampering and will work with the new Congress to produce an acceptable bill on that subject."

This completes my prepared remarks, Mr. Chairman. I will be happy to answer any questions.

[Mr. Jensen's full statement follows:]

ONE PAGE Summary of Department of JUSTICE'S TESTIMONY

Department of Justice strongly supports an anti-tampering provision.

The Department of Justice agrees with H.R. 1337, H.R. 83, and H.R. 778 that the new tampering provision should cover foods, drugs, devices, and cosmetics. The Department also believes that the labeling and containers of such products should be covered.

Department of Justice agrees that there should be a gradation of penalties for tampering but differs slightly with the penalty provisions of H.R. 1337.

Department of Justice believes that law enforcement interests would be best served if provisions are included to permit investigatory responsibilities for violations to be shared by the FBI, FDA, and other Department of Agriculture personnel. Department of Justice does not favor increasing the penalty for tampering with food or drugs with intent only to damage business reputation where there is no intent also to cause death or bodily harm to an individual by such tampering.

Department of Justice believes that federal jurisdiction should extend only through the conclusion of the retail process.

Department of Justice believes that the bill should cover actual tamperings, attempted tamperings, threatened tamperings, and conspiracies to tamper.

Department of Justice supports a hoax provision with suitable misdemeanor and felony treatment.

Department of Justice submits a draft bill which accomplishes its recommenda

tions.

PREPARED STATEMENT OF D. LOWELL JENSEN, ASSISTANT ATTORNEY GENERAL, CRIMINAL DIVISION, U.S. Department oF JUSTICE

Mr. Chairman and Members of the Subcommittee: My name is D. Lowell Jensen. I am the Assistant Attorney General in the Criminal Division of the Department of Justice.

I appreciate the opportunity to appear here today to provide the views of the Department of Justice in support of the concept of imposing additional federal criminal sanctions for the tampering with food, drugs, devices, or cosmetics as such terms are defined in title 21, United States Code.

The Department of Justice strongly supports enactment of legislation that would impose more stringent criminal sanctions against those persons who would tamper with such products with intent to kill, injure, or endanger another person. In our view, present federal statutes do not adequately address this type of criminal activity, which often may have tragic consequences to both the users and the manufacturers of the affected products.

Commencing with the widely reported Tylenol tampering tragedies occurring in the Chicago area in September of last year, our country experienced a number of reported incidents of tampering in which poisons or other harmful or caustic substances have been added to pharmaceutical, cosmetic, and food products. While fortunately the number of such incidents has apparently diminished, the results of these criminal acts were profound and tragic. In the Tylenol incidents, seven persons died because cyanide had been added to this widely used non-prescription pain remedy. In several hundred subsequently reported incidents, sometimes referred to as "copycat" crimes, other persons have reportedly experienced injuries or illness as the result of their use of pharmaceutical and cosmetic products that had also been adulterated through the addition of poisons or caustic substances.

In addition to the terrifying risk of actual exposure to potentially life-threatening adulterants in the foods, drugs, devices, or cosmetics consumed or used by them, members of the public may experience added adverse effects attributable to incidents of the tampering. Consumers may find some of these products upon which they rely temporarily unavailable due to recalls of the affected products, or permanently unavailable due to a withdrawal from the marketplace by the manufacturer.

Consumer confidence in otherwise efficacious and safe products may be undermined by actual or imagined risks associated with such products.

In short, the health, nutrition, convenience, and comfort of the American public are put at risk as the result of the heinous and despicable acts of a food or drug tamperer.

As the result of tampering incidents, the manufacturers of the affected products may suffer enormous financial loss and severe damage to the reputations of their otherwise useful and necessary products. For example, Johnson & Johnson's McNeil Laboratories, the manufacturer of Tylenol, has reportedly estimated the cost of warnings to the public after the Chicago poisonings, and the costs of recall, testing, and destruction of capsules to have been $100 million.1 Whether most manufacturers would be able to withstand the potentially destructive losses of a product tampering incident is seriously questionable.

The potential for withdrawal of manufacturers from the marketplace, accompanied by the resulting decrease in competition in the pharmaceutical, food, device, and cosmetic industries, loss of jobs, and the narrowing of the range of product choices available to consumers could have dramatic adverse effects on the American economy and standard of living.

Thus, food and drug tampering is an appropriate matter for national concern. Moreover, Federal investigation and prosecution of such criminal conduct is appropriate. A single act of tampering at any of a number of stages in the national distribution chain for most foods, drugs, devices, and cosmetics could lead to injury or illness among the citizens of a number of states. Local and state law enforcement authorities may be limited in their ability to conduct and coordinate the investigative and prosecution functions necessary to address this serious national concern. In addition, the disruption of food, drug, device, or cosmetic supplies nationally as a result of even an intrastate tampering incident could have serious adverse effects on interstate commerce in such products. Accordingly, it is the view of the Department of Justice that a Federal response to this national problem is necessary to augment the presently available local and state resources.

It is further our view that present Federal law inadequately addresses the crime of food or drug tampering. The Federal Food, Drug and Cosmetic Act (the "Act") prohibits, among other things, "The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adultered or misbranded," "The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce"; "The receipt in interstate commerce of any food, drug, device, or cosmetic that is adultered or misbranded, and the delivery or proffered delivery thereof for pay or otherwise"; and "The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded." 21 U.S.C. §§ 331 (a), (b), (c), and (k).

Other sections of the Act determine whether the food, drug, device, or cosmetic is adulterated or misbranded.2 Under the penalties section of the Act, 21 U.S.C. § 333, the commission or causing of any of the prohibited acts enumerated in 21 U.S.C. § 331 is a misdemeanor, punishable by a maximum sentence of one year's imprisonment and a $1,000 fine (21 U.S.C. § 333(a)); unless the violation is committed after a prior conviction has become final, or is committed with intent to defraud or mislead, in which case it is punishable by a maximum sentence of three years' imprisonment and a $10,000 fine (21 U.S.C. § 333(b)).

While the provisions of the Federal Food, Drug, and Cosmetic Act would be applicable to most reported acts of tampering, they do not adequately punish or deter the serious and vicious conduct of tampering with such products with intent to harm others. Accordingly, it is our view that additional legislation is necessary to address this most despicable criminal activity.

The Food and Drug Administration, the agency charged with administration of the Federal Food, Drug, and Cosmetic Act, has undertaken a regulatory initiative aimed at preventing tampering incidents of the type recently reported. On November 5, 1982, the Food and Drug Administration published a Final Rule providing requirements for tamper-resistant packaging and certain labeling for certain over-thecounter (OTC) human drug and cosmetic products. 47 Fed. Reg. 504442. This laudable regulatory initiative, undertaken with industry support, is a major step toward

1 FDC Reports Vol. 44, No. 46 at 8 (Nov. 15, 1982).

2 The general adulteration and misbranded provisions are the following: Foods, 21 U.S.C. §§ 342, 343; Drugs and Devices, 21 U.S.C. §§ 352, 353; Cosmetics, 21 U.S.C. §§ 361, 362.

preventing a recurrence of tampering incidents such as those experienced in connection with the Tylenol poisonings. This preventative initiative, however, does not guarantee that tampering incidents involving the covered products and others will not occur in the future. Accordingly, the Department of Justice believes that more stringent criminal penalties should be enacted to deter and punish food and drug tampering.

I have attached to my statement a draft version of a bill which in our judgment would redress the major gaps in existing law. Unlike some other bills which have been introduced, our proposal is confined to deal primarily with the situation created by the recent Tylenol and other drug tampering incidents.

The draft bill, like H.R. 1337, would amend title 18 of the United States Code to add a new section 1365. It prohibits and prescribes stiff felony penalties for the adulteration of any food, drug, device, or cosmetic, or the misbranding of the labeling or container thereof, with the intent to kill, injure, or otherwise endanger the health or safety of any person. It also covers attempts, threats, and conspiracy as well as hoaxes.

The draft bill contains a penalty scheme similar to H.R. 1337 which varies depending upon the harm done. Borrowing from the Chairman's prior bill, H.R. 7362 in the 97th Congress, it defines the intent as knowing or having reason to know the normal and usual consequences of the adulteration or misbranding. We regard this as an important feature of the legislation and regret its absence from H.R. 1337. Moreover, like H.R. 7362 and H.R. 1337, the bill would cover any food, drug, device, or cosmetic (but not other products) from the manufacturing stage through the retail process. Unlike H.R. 1337, the draft bill reaches tampering with the labeling of food, drug, device, or cosmetic products inasmuch as the potential for human harm from such tampering is as great as from a tampering with the product itself. This draft bill in our judgment focuses on the most crucial products; builds upon existing law; has significant penalties; covers misbranding as well as tampering; and is aimed at those persons intending to harm individuals.

While there are great similarities between H.R. 1337 as introduced by the Chairman and our draft bill, there are also some significant differences which I have set forth in an attachment to my statement. For example, unlike H.R. 1337 and some other bills, our proposal specifically grants concurrent investigative authority to appropriate employees of the Federal Drug Administration and the Department of Agriculture as well as the Federal Bureau of Investigation. This has the important practical result of permitting the appropriate federal regulatory agency to participate with the Federal Bureau of Investigation in the investigation. In our judgment, the expertise of Federal Drug Administration investigators or the meat, egg, and poultry investigators of the Department of Agriculture could be crucial in the successful solution of many crimes of the type to be proscribed.

There are two other general areas which have been addressed in various measures relating to the tampering problem. They are: (1) tampering with intent to damage business reputation; and (2) tampering with other than food or drug products. As to the former, it is our belief that any intentional tampering which foreseeably will result in bodily injury should be prohibited regardless of the motive of the perpetrator. This would include tampering done with intent to kill or injure a person as well as tampering with intent to harm business reputation. On the other hand, penalizing tampering with intent to damage business reputation as a separate branch of prohibited conduct would reach instances in which no physical harm to a person was contemplated or could result, e.g., putting a harmless purple dye in orange juice. While such conduct may harm business reputation, we do not believe it is on the same order of magnitude as conduct involving tampering that may injure or take human life; nor is a tampering that is without the possibility of physical harm to the consumer likely to result in as much of a harm to business reputation. Moreover, we are not aware of any pattern of incidents of this kind which would be likely to require investigation by the Federal Government. Accordingly, we see no reason warranting coverage of intent to damage business reputation as a separate offense in new federal tampering legislation. As to expanding this statute to other products besides food and drugs, we are apprehensive. To date, we have not experienced any significant tampering with such products. To expand coverage in the lack of a demonstrable need may raise a host of problems presently not within contemplation. Hence, we would urge more study of the need for any such expan

sion.

We would urge the Committee to give our draft bill favorable consideration, and point out that H.R. 1337 is certainly in a framework with which we are confident that suitable accommodation can be reached. As President Reagan said in his veto statement on H.R. 3963 of the last Congress, we "share the widespread public desire

for new legislation on tampering and will work with the new Congress to produce an acceptable bill on that subject."

That completes my prepared remarks. I would be pleased to answer any questions you may have.

DEPARTMENT OF JUSTICE DRAFT BILL

Be it enacted by the Senate and House Representatives of the United States of America in Congress assembled, That this act may be cited as the "Federal AntiTampering Act of 1983."

SEC. 2. Chapter 65 of title 18 of the United States Code is amended by adding at the end thereof the following new section:

"§ 1365. Tampering with consumer products with intent to cause injury or death "(a) Whoever alters, tampers with, or does any other act with respect to a food, drug, device, or cosmetic, or the labeling or container thereof, which is in, is intended to be in, or continues to affect, interstate or foreign commerce, with the intent to kill, injure, or otherwise endanger the health or safety of any person, if such act results in such food, drug, device, or cosmetic being adulterated or misbranded, or attempts, threatens, or conspires to do so, shall be imprisoned for not more than ten years or fined not more than $20,000, or both; and if serious bodily injury results, shall be imprisoned for not more than twenty years or fined not more than $50,000, or both; and if death results, shall be imprisoned for any term of years or for life or fined not more than $100,000, or both.

"(b)(1) Whoever imparts or conveys false information, knowing the information to be false, concerning an act or attempted act which, if true, would constitute a violation of subsection (a) shall be imprisoned for not more than one year or fined not more than $10,000, or both.

"(2) Whoever willfully and maliciously imparts or conveys false information, knowing the information to be false, concerning an act or attempted act which, if true, would constitute a violation of subsection (a) shall be imprisoned for more than five years or fined not more than $25,000, or both.

"(c) Violations of this section may be investigated by the Federal Bureau of Investigation in addition to any other Federal agency having investigative jurisdiction under title 21, United States Code, for such violation.

"(d) A person has the intent required for an offense under this section if the person knows or has reason to know that the normal and usual consequence of the actual, attempted, or threatened alteration, tampering or other act would be to kill, injure, or otherwise endanger the health or safety of any person.

"(e) As used in this section

"(1) the term 'food' has the definition given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)) and also includes 'meat food product' as such term is defined in section 2(j) of the Federal Meat Inspection Act (21 U.S.C. 601(j)), 'poultry' as such term is defined in section 4(d) of the Poultry Products Inspection Act (21 U.S.C. 453(e)), 'poultry product' as such term is defined in section 4(e) of the Poultry Products Inspection Act (21 U.S.C. 453(f)), ‘egg product' as such term is defined in section 4(f), of the Egg Products Inspection Act (21 U.S.C. 1033(f)), and 'egg' as such term is defined in section 4(g) of the Egg Products Inspection Act (21 U.S.C. 1033(g));

"(2) the term 'drug' has the definition given such term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1));

"(3) the term 'device' has the definition given such term in section 201(h) of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h));

"(4) the term 'cosmetic' has the definition given such term in section 201(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(i));

"(5) the term 'labeling' has the definition given such term in section 201(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(m));

"(6) the terms 'adulterated' and 'misbranded' have the defintions given such terms in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.); and

"(7) the term 'serious bodily injury' means bodily injury to a person which involves

"(A) a substantial risk of death;

"(B) extreme physical pain;

"(C) protracted and obvious disfigurement; or

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"(D) protracted loss or impairment or the function of a bodily member, organ or mental faculty."

SEC. 3. The table of sections at the beginning of chapter 65 of title 18 of the United States Code is amended by adding at the end the following new item:

"1365. Tampering with consumer products with intent to cause injury or death.".

COMPARISON BETWEEN H.R. 1337 AND DOJ DRAFT BILL

L. PLACEMENT IN CODE

H.R. 1337 and the DOJ draft bill both place the provision in Chapter 65 "Malicious Mischief" of Title 18, United States Code. Both provisions incorporate certain definitions from the Federal Food, Drug, and Cosmetic Act in Title 21, United States Code with the DOJ provision also incorporating the definitions for “labeling,” “adulterated," and "misbranded."

IL PRODUCTS COVERED

There is no difference. Both bills cover foods, drugs, devices, and cosmetics intended for human use or consumption. (Neither version covers food for animals.)

III. JURISDICTIONAL SCOPE

H.R. 1337 is broader as it covers such products which "at any time affects interstate and foreign commerce" (emphasis added). This would appear to cover such products during their entire duration. The DOJ draft bill commences federal jurisdiction at the same time as H.R. 1337 but the phrase “continues to affect . . . commerce" is designed to terminate federal jurisdiction once the retail process is completed. Hence, the DOJ draft would not cover the poisoning of medicine in one's own home where the poisoned medicine is not placed back on a retail shelf. The DOJ draft recognizes that there are appropriate limitations to the exercise of federal jurisdiction and we believe the example provided indicates an area which is more properly within the sole cognizance of state and local authorities.

IV. CRIMINAL ACTS COVERED

Both measures cover tampering with the product itself and attempts. But the DOJ draft bill also covers threats, conspiracy, and tampering with the label. Moreover, the DOJ version uses the concepts of “adulteration” and “misbranding" in Title 21, which are well understood among these types of products. The DOJ draft also covers hoaxes as such acts can cause considerable expense to the victim company and inconvenience to the consuming public.

V. CRIMINAL INTENT

While both bills are similar in requiring an intent to cause death or bodily injury, H.R. 1337 also requires the actual result of such death or bodily injury or an attempt to cause such result. The DOJ draft bill requires an "intent to kill, injure, or otherwise endanger the health or safety of any person," and does not require an actual death or injury or attempt to cause the result beyond the prohibited tampering. In our view, a tampering committed with the proscribed intent is itself seriously culpable and amounts to an attempt. To require more is unwarranted and is likely to lead to difficulties of proof and confusion.

VI. INFERRED KNOWLEDGE

The Justice Draft allows proof of the required intent if the perpetrator knew or had reason to know that the normal and usual consequence of his act would be to kill, injure or otherwise endanger the health or safety of any person. Hence, there would be no defense for a person who knowingly placed arsenic in a medicine (knowing that arsenic can kill) with the intent to extort money or ruin a competitor's product, but did not "intend" to kill anyone as he planned to reveal the location of the adulterated product before physical harm befell a customer. Such a defense should not be permitted inasmuch as the perpetrator has knowingly placed lives in jeopardy-conduct sufficiently dangerous to warrant severe criminal sanction.