Labeling Requirements for Insecticides and Other Economic Poisons under Federal Law W. G. REED
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Insecticide Division, Livestock Branch, U. S. Department of Agriculture, Washington, D. C.
The Federal Insecticide, Fungicide, and Rodenticide Act affords added protection against the dangers inherent in the use of newer means of pest control. The manufacturer has greater responsibility for furnishing specific information as to how the product can be used effectively but without damage to the user, crops or animals, or the public.
T h e Federal Insecticide, Fungicide, and Rodenticide A c t regulates the marketing i n interstate commerce of insecticides, fungicides, rodenticides, and herbicides. Instruments and contrivances intended for trapping, destroying, repelling, or mitigating insects or rodents, or destroying, repelling, or mitigating fungi, are also covered b y the act. This law, which was enacted on June 25,1947, superseded the Insecticide A c t of 1910. The old law covered only insecticides and fungicides and did not control the marketing of such products as effectively as does the new law. T h e new legislation became effective for devices on June 25, 1947, for rodenticides and herbicides on December 25, 1947, and for i n secticides and fungicides on June 25, 1948. Tremendous progress has been made i n the development of pest-control measures i n recent years, and with i t has come an increased interest by the general public i n pest control. People are beginning to realize that it is no longer necessary to put up with pests that annoy man and carry disease, or continue to suffer heavy economic losses caused b y the many pests that attack livestock, growing crops, and forest and other agricultural products. Research has provided better tools and methods than were ever before available for combating these pests and research is continuing to improve them. Unfortunately, however, many of the chemicals used i n pest control are highly toxic to man and animals. Great care must be exercised i n handling the more toxic materials to prevent injury to man, useful animals, and vegetation. Contamination of foods with harmful residues must at all times be avoided. N o doubt highly toxic substances will always have an important place i n pest control operations, but they need to be used with great care, precision, and discrimination. The new law is intended to afford the public added protection to avoid the dangers inherent i n the use of these new and more effective means of pest control. I t places upon the manufacturer greater responsibility for furnishing the user specific information as to how the product shall be used to be effective i n controlling pests, and at the same time cause no damage to the user or his crops or animals. Containers of insecticides and other economic poisons must bear labels showing the name or brand of the article, the net contents, the name and address of the manufacturer or distributor, an ingredient declaration, an appropriate warning or caution statement, including the word " P O I S O N " (in red), the skull and crossbones, and a n antidote statement on highly toxic materials. Adequate directions for use must accompany each economic poison. Devices subject to the act are not required to bear labels; but if they 17
AGRICULTURAL CONTROL CHEMICALS Advances in Chemistry; American Chemical Society: Washington, DC, 1950.
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do, no false or misleading representations may be made on labels or i n accompanying literature.
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Registration of Economic Poisons Before an insecticide or other economic poison may be marketed legally i n interstate commerce, it must be registered with the U n i t e d States Department of Agriculture. T h i s procedure brings the product to the attention of the department before i t is tried out on the public. It gives the department an opportunity to examine the proposed claims and to question those which are likely to cause injury, before the product goes on the market, i n stead of waiting, as under the old law, until the product has been marketed, a sample of i t analyzed and tested (which might take many months), and court action instituted. T o obtain registration, an application, together with the formula and proposed labeling, must be submitted to the department. This material is closely scrutinized b y scientific personnel i n the various fields involved and, if the proposed claims appear warranted and the submitted material is otherwise i n compliance with the law, a notice of registration is issued. If the article is such as not to warrant the proposed claims, or if i t and the labeling or other material required to be submitted do not comply with the law, the applicant is notified of the deficiencies and given an opportunity to make necessary corrections. If he then insists, i n writing, that such corrections are not necessary and requests that the article be registered, the law requires that i t be done under protest. B e cause of the higher penalties that are imposed if a person or firm is found guilty i n court of marketing a misbranded or adulterated product that has been registered under protest, there is little interest on the part of manufacturers and distributors i n obtaining this type of registration. E v e n though a product is registered unconditionally, the responsibility of the person or firm marketing i t is i n no way changed thereby. Under the law, registration cannot be used as a defense for the commission of any crime prohibited b y the law. Furthermore, registration can be canceled at any time if, upon the basis of later information, it appears that the labeling, previously accepted, does not give the protection intended by the law. It is the policy of the Insecticide Division, when labeling for a new economic poison is submitted for registration, to require reasonably conclusive evidence that the material can be used safely and effectively if the accompanying directions and precautions are followed. The marketing of pest-control materials before the hazards involved i n their intended uses are known can be a dangerous procedure. If reasonable doubt exists as to effectiveness or safety when proposed directions and precautions are followed, preparations should be handled only on an experimental basis. Shipments for experimental use only are exempt from the penalties of the law if used under the supervision of any federal or state agency authorized by law to conduct research i n the field of economic poisons, or by others if a permit has been obtained from the department before shipment. Before a new chemical is first offered for federal registration, the manufacturer has often carried on considerable research and spent large sums of money developing i t to the point where he considers i t ready to market. Generally, some tests have been made by federal and state research agencies, but these tests have not been conducted on a large enough scale or over a sufficient period of time to permit specific recommendations as to all the potential uses for the product or the care needed i n handling it. I n most instances there is considerable information available from one source or another concerning the material's effectiveness for some purposes. The acute oral toxicity to the usual laboratory animal is frequently fairly well known, but adequate data, concerning chronic toxicity are in many cases lacking. Chronic toxicity studies require long periods to complete and are very costly. When sufficient information is available concerning a substance to justify releasing i t to the general public, labeling containing adequate directions for use and necessary precautionary statements should be prepared and affixed to each package. Users of economic poisons should be educated to follow directions and observe precautions i n every instance AGRICULTURAL CONTROL CHEMICALS Advances in Chemistry; American Chemical Society: Washington, DC, 1950.
REED—LABELING REQUIREMENTS UNDER FEDERAL LAW
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unless otherwise advised by competent authorities. M a n y of the new complex economic poison formulations must be handled like precision instruments. Careless use invariably leads to trouble. , E v e n when the manufacturer has carried out extended studies of his product, practical use and further experimental work will sometimes uncover faults or previously u n suspected dangers. I n such cases, appropriate changes should be made on labels without delay.
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Degree of Toxicity The regulations for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide A c t set specific dosages b y which formulations must be judged to determine the exact labeling requirements for only the "highly toxic" class of substances. Briefly, the highly toxic category is limited to that group of the economic poisons which will kill 5 0 % or more of the laboratory animals (mice, rats, or rabbits) when the substance is administered at the dosages and i n any one of the manners described below, when ten or more animals of each species are used for assay : 1. Orally, 50 mg. per kg. 2. B y inhalation, 200 parts of a poison per 1,000,000 parts of air b y continuous inhalation for 1 hour or less. 3. B y skin contact (rabbits only), 200 mg. per kg. by continuous contact with bare skin for 24 hours or less. Economic poisons which have acute toxicity of varying degrees below the highly toxic' category have been segregated somewhat arbitrarily into three additional groups. T h e first might well be called the one requiring a " W A R N I N G : M A Y B E F A T A L I F S W A L L O W E D " type of label, and includes mixtures which are less hazardous than those i n the "highly toxic" group but are still toxic enough to be somewhat hazardous to handle. M a n y economic poison formulas which are not toxic enough to require the word " P O I S O N " (in red), the skull and crossbones, and an antidote statement are capable of causing injury and must carry suitable precautionary labeling for public protection. The second group is one i n which formulations having minor hazards are placed. This class may be characterized b y " C A U T I O N : H A R M F U L I F S W A L L O W E D " type of designation. The final group is the rather small class of compounds which have a relatively low toxicity and require no precautionary statements. I n this class are a number of products for which claims of absolute safety cannot be used logically because some injury to beneficial plants or animals remains. These major categories are based largely on acute toxicity records, but the significance of chronic poison hazards to the adequacy of " w a r n i n g " and "directions-for-use" labeling is given full consideration whenever it is a factor for public protection. N o specific wording for precautionary labeling has been felt to be necessary or a d visable, but certain patterns of suitable statements are being prepared by a number of groups, notable among which are the Labels and Precautionary Information Committee of the Manufacturing Chemists' Association and the Committee on Toxicity and A n t i dotes of the Association of Economic Poisons Control Officiais. The Insecticide Division maintains close liaison with these groups and others interested i n the problem, and acceptable recommendations are being worked out. Labeling will, of course, never be a static proposition, because initial warnings and directions for use will be subject to change as more precise information on economic poison formulations becomes available.
Federal and State Regulations One of the difficulties encountered b y producers of economic poisons has been the preparation of labeling which will comply with the laws and regulations of both the Federal Government and the various states i n which the product is marketed. This difficulty has been aggravated by differences i n interpretation by different enforcement officials. The Insecticide, Fungicide, and Rodenticide A c t recognizes this difficulty and authorizes the AGRICULTURAL CONTROL CHEMICALS Advances in Chemistry; American Chemical Society: Washington, DC, 1950.
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administrative authorities to cooperate with state regulatory agencies i n carrying out the provisions of the law and i n securing uniformity of regulations. F u l l advantage is being taken of this authorization through both cooperative arrangements for enforcement work and discussion with representative groups of state officials. I n consultation with the Executive Committee of the Association of Economic Poisons Control Officials, a set of interpretations of the federal regulations has been prepared and published, so that the manufacturer and all others concerned can be governed accordingly. The closer cooperation between federal and state officials is tending to iron out differences and make the marketing of useful economic poisons on a nation-wide basis a much easier job.
AGRICULTURAL CONTROL CHEMICALS Advances in Chemistry; American Chemical Society: Washington, DC, 1950.
