83D CONGRESS 1st Session

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SENATE

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REPORT No. 712

AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC ACT SO AS TO PROTECT THE PUBLIC HEALTH AND WELFARE BY PROVIDING CERTAIN AUTHORITY FOR FACTORY INSPECTION

JULY 29 (legislative day, JULY 27), 1953.—Ordered to be printed

Mr. PURTELL, from the Committee on Labor and Public Welfare, submitted the following

REPORT

[To accompany H. R. 5740]

The Committee on Labor and Public Welfare, to whom was referred the bill (H. R. 5740) to amend the Federal Food, Drug, and Cosmetic Act, so as to protect the public health and welfare by providing certain authority for factory inspection, and for other purposes, having considered the same, report favorably thereon with an amendment and recommend that the bill, as amended, do pass.

The amendment is as follows:

On page 4, line 10, add a new section 4 as follows:

SEC. 4. Section 503 (b) of such Act, as amended [Public Law 215, 82nd Congress, 21 U. S. C. 353 (b)], is amended by adding a new paragraph (6) as follows:

"(6) Prescription files in retail drugstores may be inspected only in accordance with the procedure described in Section 704, as amended, and only when the officer or employee giving notice of inspection (A) has reason to believe that the retail drugstore has dispensed drugs in violation of this section; or (B) is engaged in tracing the distribution of dangerously adulterated or misbranded drug or a new drug for which there is no effective application under Section 505."

PURPOSE OF THE BILL

To protect the public health and welfare, the Federal Food, Drug, and Cosmetic Act was enacted in order to keep out of and remove from the channels of interstate commerce adulterated and misbranded food, drugs, therapeutic devices, and cosmetics and to prevent the adulteration and misbranding of such articles after interstate shipment but while they are held for sale.

The primary purpose of this bill is to provide clear and enforcible statutory authority for the Food and Drug Administration to inspect factories and other establishments in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held.

The power to make such inspections is necessary for two reasons: (1) To encourage compliance with the act by bringing to light conditions which may cause products to be adulterated or misbranded, thus enabling manufacturers and processors to correct the conditions and to withhold adulterated or misbranded products from the channels of interstate commerce; and

(2) To facilitate enforcement of the act in those cases in which adulterated or misbranded products are shipped in interstate commerce or are held for sale after such shipment.

It has become urgently necessary in the interest of public health and safety clearly to establish inspection authority because on December 8, 1952, the Supreme Court in U. S. v. Cardiff (344 U. S. 174) held that the present provisions of the Federal Food, Drug, and Cosmetic Act do not clearly provide that the refusal to admit a food and drug inspector constitutes a violation of that act. The Court held that the existing law is fatally inconsistent because Congress in one provision (sec. 704) authorized inspections "after first making request and obtaining permission of the owner, operator, or custodian" of the factory, or other establishment, but in another provision (sec. 301 (f)) prohibited the refusal to permit entry or inspection.

The situation resulting from the Supreme Court decision is that operators in the food, drug, and cosmetic industries will have an opportunity, through refusal to permit inspection, to disregard with impunity the sanitary and other safeguards in the Federal Food. Drug, and Cosmetic Act. While an overwhelming majority of operators in these industries would not take advantage of this situation, there is reason to fear that the small minority which would take advantage would be sufficient to threaten the high general level of sanitation and standards of product safety and integrity intended to be achieved by the act and commonly observed by the more responsible operators in these industries. Furthermore, the resulting saving in costs to this minority would make it possible to engage in methods of competition which would be unfair to the responsible operators.

The decision of the Supreme Court denying that Congress had granted enforcible inspection power, which is indispensable to the effective enforcement of the act, has, therefore, seriously jeopardized the protective services rendered by the Food and Drug Administration.

Until this case was decided, the act was interpreted and administered by the Food and Drug Administration, with the concurrence of the overwhelming majority of the responsible trade organizations and members of the food, drug, and cosmetic industries, as granting the Administration the right to insist that its inspectors be permitted to enter and inspect.

In view of the serious hazard to the public health and safety which may well result from the denial of this power, the President, in his message on the state of the Union, urged the Congress to restore the power of the Food and Drug Administration to make factory inspec tions. In the course of a nationwide television broadcast on June 3, 1953, the new administration repeated this urgent request.

In addition to making the changes in present law necessary to make sure that the Food and Drug Administration will have adequate inspection authority, this bill contains certain other proposed changes in existing law intended to assist manufacturers and processors in

complying with the law. These provisions, which are discussed below in the analysis of the bill, provide among other things that:

(1) Upon completion of an inspection the inspector shall give to the factory owner a report in writing with respect to the conditions observed which bear on sanitation or other conditions of a similar nature. This report must be given before the inspector leaves the premises.

(2) When any sample is obtained in the course of an inspection, the inspector must give a receipt therefor to the factory owner, describing the samples obtained.

(3) Whenever in the course of an inspection of a factory where food is manufactured, processed, or packed, the inspector obtains a sample of any food, and an analysis is made of such food to determine whether it contains filth, decomposition, or other similar contamination, a copy of the results of the analysis must be furnished to the factory owner.

The bill was carefully considered by this committee's Subcommittee on Health, and the committee is convinced that passage of this legislation is needed and is greatly in the public interest.

ENFORCIBLE INSPECTION POWER IS NECESSARY

The committee is satisfied that the bill provides a practical and realistic type of enforcible inspection authority. It is evident to the committee that if the Food and Drug Administration were to be deprived of such authority and were empowered only to make such inspections as are voluntarily agreed to by the persons whose establishments are to be inspected, the Federal Food, Drug, and Cosmetic Act would become virtually meaningless. Those who voluntarily would permit inspections have nothing to hide and always have welcomed inspections. It is the small minority of operators-those who carry out substandard operations and the racketeer typeswho would not volunteer, because they almost invariably do have some reprehensible condition to hide. Voluntary inspection would deny inspection authority where it is most vitally needed for public protection. Dangers to life and health and such obvious frauds as palming off horsemeat for hamburger could be expected to increase in the absence of proper and enforcible inspection authority.

Moreover, such authority would avoid unfair competition from the fringe and racketeer operators that would necessarily force down the present high levels of sanitation, product safety, and honesty and fair dealing.

The inspection powers which were exercised by the Food and Drug Administration prior to the decision in the Cardiff case, and which are provided for by this legislation, are a necessary part of a regulatory scheme intended to protect the health and lives of the public. The inspections are normally a matter of routine checking, primarily as to sanitary and related conditions but also as to product integrity and safety for use, and are not necessarily based on any prior suspicion or determination that the law has been or is being violated. As has been pointed out, one purpose of such inspections is to encourage compliance with the Food, Drug, and Cosmetic Act by bringing to light conditions which may cause products to be adulterated or misbranded, thus enabling manufacturers and processors to

correct conditions and to withhold adulterated or misbranded products from the channels of interstate commerce.

This legislation does not propose that food and drug inspectors shall have the power of arrest, or the power to use force in order to gain admission to a factory or otherwise carry out an intended inspection. And there is no proposal that they be authorized to confiscate adulterated or misbranded articles. The bill authorizes entry and inspection but does not authorize the inspector to enter the establishment by force. The owner is on notice, however, that he must permit a reasonable inspection. If he refuses such an inspection he is in violation of the act.

REASONABLE INSPECTIONS

The bill places emphasis on the fact that the authorized inspection must be reasonable in time, manner, and extent. What is reasonable, of course, depends on the circumstances of the specific case, and hard and fast rules cannot be laid down. The Supreme Court, many times, has recognized this, as have other courts.

The bill clearly is not intended to authorize "fishing expeditions" into private papers such as financial accounts, the ordinary personnel records, and payrolls. But it is intended to provide the Food and Drug Administration with sufficient inspection authority to protect the public. It is intended, for example, to provide a means of knowing the composition of finished and unfinished materials whenever the composition of such articles is relevant to compliance with the law. There is no shield here by which ingredients that may be poisonous and dangerous, or products containing them, would be withheld from the inspection. Nor does the bill countenance a situation in which some worthless ingredient could be held secret from the inspection-and thus from the courts-making it impossible to prove the falsity of claims made for the product in question, whether it be a food, drug, device, or cosmetic. Provisions of the existing law afford protection against unauthorized disclosures of any trade secrets learned during factory inspection (21 U. S. C. 331 (j)).

The committee recognizes that inspection means to "examine critically," and the words of the statute should be given meaning consistent with the overall purpose of the act in protecting the public.

Furthermore, in appraising the plant performance from the standpoint of compliance with the law, the inspector should not be prohibited from inquiring whether the person in charge of safety controls is qualified by training and experience. At the same time, there would be no basis for insisting that the person's entire life history be exposed to inspection through complete examination of his personnel records.

The bill does not authorize withholding from the inspector the fact that injury complaints have been made to the firm. Such complaints sometimes provide the first notice of impending public danger. and prompt action may be necessary to withdraw the dangerous article before additional and needless injuries occur.

The bill is not specific in spelling out exactly what would be reasonable in any and all circumstances. Such a detailed specification would be impossible. The general rule of reasonableness, used in the bill. however, seems eminently fair both to the public and to private business.