Document x1jyzjoq5QB4VXJqRbE6ggrXm

N15442 S-W 003484 . 2 Preface 3 Introduction 3 The Household Poisoning Problem 3 Injuries and Fatalities 4 Legislative History 5 Scope and Definitions 5 Coverage of the Act 5 What is a Banned Hazardous Substance? 6 What is a Hazardous Substance? 6 Toxic and Highly Toxic Substances 7 Other Definitions 8 Specific Exemptions 9 Labeling 9 Specific Label Information Required 10 Preparation of Warning Labels 12 Arrangement of Required Information 16 Statement of Hazards 16 Statement of Precautionary Measures 16 Condensation of Label Information 16 First-Aid Instructions 18 Handling and Storage Instructions 18 Examples of Acceptable Label Statements 20 Enforcement Procedures and Penalties 21 Seizure of Violative Shipment 21 Criminal Prosecution 21 Injunction 22 22 22 22 . 23 23 Further Information and Source Material FDA Mailing List FDA Papers Official FOA Publications Information from Other U.S. Government Agencies Information from Mon-Federai Government Agencies back cover List of District Offices and Addresses S-W 003436 T & ?* This publication is a digest of the rules and regulations contained in the Federal Hazardous Substances Act, and Part 191, Title 21, Code of Federal Regulations. The information and illustrative labels contained herein represent the best current opinion on the subject However, this publication is intended solely as a guide for the manufacturer of a product subject to the Federal Hazardous Substances Act It must not be assumed that ail necessary warnings, precautionary measures, exemptions and exceptional conditions or circumstances ate contained in this booklet Complete and official information is contained only in the Act itself, and the applicable Regulations. The Food and Drug Administration recommends that any manufacturer of a hazardous substance seek the best available legal and technical advice in the preparation of a label. FDA will be glad to informally comment on a proposed label, following the procedure outlined in this booklet In the writing of this publication, certain frequently used expressions have been shortened for editorial purposes: "the Act' means the Federal Hazardous Substances Act; "CFR" is the Code of Federal Regulations; "Regulations" for the purposes of the publication only refers to Part 191, Title 21, Code of Federal Regulations; "Secretary" refers to the Secretary of Health, Education, and Welfare. The authority granted to the Secretary of Health, Education, and Welfare for enforcement and administration of the Federal Hazardous Substances Act has been delegated to the Commissioner of Food and Drugs. S-W 003487 Introduction Requirements of the Federal .Hazardous Substances Act THE HOUSEHOLD POISONING PROBLEM Many household materials are harmful or poisonous if misused and may cause serious injury or even death--not only by swallowing, but by inhalation of fumes, contact with skin or mucous membranes. fire, or explosion. The very color and design of modem packaging, created for impulse buying, offers an iimsistible attraction to small ^ftdren, making the hazardous product an interesting--and sometimes fatal--subject for childish investigation. Compounding this situation are the many articles, which by design or intended use, cannot be packaged. Color, curiosity, and chemicals--these are the factors that make our homes virtual booby-traps for the very young, or unwary adults. INJURIES AND FATALITIES The Public Health Service estimates that annually 500,000 children swallow products left within reach and, as a result, about 500 die. However, such injuries and fatalities I \ ^ are not confined to children and j many adults are injured, and | sometimes killed, in the use of ! household products. Almost 90 percent of all poisonings occur in the home. Part of the .public health problem comes from *;the fact thajt many household ' * hazardous substances are new and f unfamiliar products, and the : consumer or user is not aware of the inherent danger. Many preparations bear neither adequate warnings to prevent accidental misuse nor information 1'^necessary to assure safe use and storage. Often there is no information 'about potentially harmful ingredients on the label and no instructions for first-aid treatment. Thus, a doctor might have to call the nearest Poison Control Center or the manufacturer for information about an antidote. Meanwhile, time is lost--perhaps the time in which a life could be saved. The most practical way to provide users and physicians with the information (hey need for safe use or first-aid treatment is the label. S-W 003488 LEGISLATIVE HISTORY Congress recognized this problem in 1927 with the passage of the Federal Caustic Poison Act At that time there were only 12 caustic and corrosive substances covered by the Act After World War Two a multitude of household chemical products became available in hardware, drug, grocery, and variety stores, as well as in specialty outlets such as paint stores, hobby shops, auto supply stores, etc Realizing that the Federal Caustic Poison Act was no longer adequate for public health protection. Congress enacted and the President signed, on July 12, 1960, the Federal Hazardous SubstJ j Labeling Act The Federal Caustic Poison Act was repealed, except as it applied to any food, drug, or cosmetic FHSLA required labels to carry the precautionary warnings and measures necessary for safe use and storage, as well as the information needed for appropriate first-aid or by physicians to treat cases of accidental injury. But as the Food and Drug Administration gained enforcement experience with this law, it became evident that several loopholes needed dosing. For example, as written in 1960, the law required that all household-sized containers of potentially dangerous substances be conspicuously labeled to warn the user of the danger and to provide necessary safety information. Thus, there was no jurisdiction over hazardous household artides unless they were distributed in a container. The law was, in effect, just what the name implied--a labeling law. Also, there was no effective way of dealing with products that were so hazardous that they were unsafe for household use, regardless of cautionary labeling. To correct these and other shortcomings. Congress passed and the President signed, on November 3, 1966, the Child Protection Act of 1966. This Act amended the Federal Hazardous Substances (Labeling) Act to provide: * For indusion of all hazardous substances, regardless of their wrappings, under the safeguards of the Federal Hazardous Substances Act; * A ban from interstate commercP for those household substances that are so hazardous that warning labels are not adequate safeguards; * A ban on the sale of toys and other children's artides containing hazardous substances, regardless of their packaging. One of the most significant changes was reflected by the deletion of the word "Labeling" from the title, as the Federal Hazardous Substances Act provides for consumer protection beyond that which can be realized through labeling. S-W 003489 Scope and Definitions COVERAGE OF THE ACT The Act now applies to any hazardous substance intended or packaged in a form suitable for use in the household or by children, which is introduced into interstate commerce or held for sale after shipment in interstate commerce. Regulations define hazardous substances intended or packaged in a form suitable for use in the household as those which might be brought into any place where pie dwell, or in or around a >di building such as a garage, airrt bam, or storage shed. The test is whether it is reasonably foreseeable that the container would be found in or around a dwelling and thereby expose persons to the particular hazards of the substance. The definition exdudes artides brought into a home by a repair man and industrial artides which may be misappropriated for a worker's home use 8ulk shippers of products such as kerosene, paint thinner*, turpentine, etc, customarily dispensed at retail in containers suitable for household use may wish to label the bulk container with information required on the retail container. This may remind the retailer of his responsibility and aid him in the preparation of proper labels, and bulk shippers may wish to supply the appropriate labels. WHAT IS A BANNED HAZARDOUS SUBSTANCE? The term "banned hazardous substance" was an addition to the language of the Hazardous Substances Act by virtue of the 1966 amendments. As revised, the law gives the Secretary of Health, Education, and Welfare authority to classify as a "banned hazardous substance" any hazardous substance found to be too dangerous for use S-W003490 in or around a household regardless of its labeling, and ban such substance from interstate commerce. The ruling is based on a finding that regardless of labeling, the hazard involved in the use of the article in or around the household is so great that the public health and safety can be adequately served only by keeping the substance out of the channels of interstate commerce. Before an article can be placed in this category, the Secretary must publish his finding in the Federal Register where it is subject to comments and objections. Where the statutory requirements have been fulfilled, a public hearing may take place. The law also provides procedures for review by a U.S. Circuit Court of Appeals. If the delay caused by these procedures would involve an imminent hazard to the public health, the Secretary is authorized to suspend the article from the market immediately, pending completion of hearings and judicial review. In addition, any toy or other article intended for use by children that is a hazardous substance or bears or contains a hazardous substance within the meaning of section 2 (f) (1) of the Federal Hazardous Substances Act or section 191.1, Title 21, Code of Federal Regulations, is classified as a "banned hazardous substance," unless specifically exempted. Toys or articles for children which may be exempted are those which by reason of their functional purpose require the presence of the hazardous substance, and which bear appropriate warnings and are intended for children oid enough to read and heed the warnings. * WHAT IS A HAZARDOUS SUBSTANCE? A "hazardous substance" is defined as a substance or mixture of substances which is toxic, corrosive, an irritant, flammable, or which generates pressure through heat, decomposition, or other means; or which has been designated by the Secretary as a strong sensitizer, or a radioactive material subject to the Act; and which "may cause substantial personal injury or substantial illness during or as a proximate result of any reasonably foreseeable handling or use, including reasonably forseeable ingestion by children." TOXIC AND HIGHLY TOXIC SUBSTANCES A "toxic substance" is defined in the Act as "any substance (other ' T k than a radioactive substance) which has the capacity to produce personal injury or illness to man through I ingestion, inhalation, or absorption ijftrough any body surface." II ^^A substance is classified "highly toxic" if a single oral dose of SO f milligrams or less per kilogram of body weight would kill half or more of the white rats to which I it is fed. However, human beings may be more susceptible to a particular substance than test & animals. Whenever there is reliable data available about any substance which indicates that a product is in fact "highly toxic," "toxic," "corrosive," k or an "irritant" to humans, the human data shall take precedence over animal data. If the Secretary finds the required label warnings specified in the Act are not adequate for the protection of the public health and safety in view of a special hazard presented by any particular hazardous substance, variations or additional label requirements may be established for that particular substance. t Section 191.7 and 191.109, Tide CFR, contains a current list of such particular hazardous substances and the additional or special label warnings required for these substances. OTHER DifINmONS The Act and Part 191, Tide 21, CFR, contain definitions for both "flammable" and "extremely flammable" substances in terms of standard testing procedures. Flammable solids and flammable contents of self-pressurized containers are also defined by the Regulations. The other categories of hazardous substances, while defined in general terms in the Act, are specifically explained in Section 191.1 of the Regulations. The Regulations also define the terms "substantial personal injury or illness," "proximate result," and "reasonable foreseeable handling and use". The intent of the three phrases is to assure protection not only to the purchaser or intended user of the product, but also all others in the household, especially children. A high percentage of children are prone to swallow or tamper with household aids left within their reach. S-W 003492 Specific Exemptions t The Act does not apply to economic poisons subject to the Federal Insecticide, Fungicide, and Rodenticide Act; foods, drugs, and cosmetics subject to the Federal Food, Drug, and Cosmetic Act; and source materials, special nuclear material, or by-product material as defined in die Atomic Energy Act of 1954. Substances intended for use as fuels when stored in containers and used in the heating, cooking, or refrigeration systems of a house are also excluded. This exemption applies only to containers which are intended to be or are permanently installed as part of the heating, cooking, or refrigeration systems of a house. Portable containers of such materials are not exempted and must bear appropriate cautionary labeling. The Act authorizes the Secretary to issue regulations to exempt specific substances from full label compliance, where, because of the size of the package or the minor degree of hazard presented, public health protection does not require full compliance. Any manufacturer may request such an exemption, if he believes he is entitled to it, by submitting a request to the Commissioner of Food and Drugs. Such requests should be supported by any available data, including complete quantitative formula and physical characteristics, and summaries of any previous experience in marketing the product or closely related products. As explained in a previous paragraph, the Act also provides for exemption from classification as a "banned hazardous substance" of certain toys and other articles A) intended for use by children, unde* certain conditions. Section 191.62 gives the procedures for requesting an exemption. Sections 191.63 and 191.65 list exemptions that have been granted. S-W 003493 Labeling SPECIFIC LABEL INFORMATION REQUIRED must bear the following information: of the manufacturer, packer, distributor, or seller. 2. The common or usual name or the chemical name (if there is no common or usual name) of each component that contributes substantially to its hazard, unless the Secretary by regulation permits a t requires the use of a recognized Hheric name. (When the sole nazatd from a substance in a selfpressurized container is that it generates pressure, or when the sole hazard from a substance is that it is flammable or extremely flammable, th` e name o'f t-hL e c--o---m-----p---o---n---e---n-*t which contributes the hazard need not be named.) 3. The signal word "DANCER" on substances which are extremely flammable, corrosive, or highly toxic 4. The signal word "WARNING" or "CAUTION" on all other hazardous substances. 5. An affirmative statement of the principal hazard or hazards, such as "FLAMMABLE,'' "VAPOR HARMFUL," "CAUSES 8URNS "HARMFUL OR FATAL IF SWALLOWED," or similar wording to describe the hazard. 6. Precautionary measures describing the action to be followed or avoided, except when this requirement is modified by regulation. 7. Instruction, when necessary or appropriate, for first-aid treatment (This may need to be supplemented with the statement: "Call a physician immediately.") 8. The word "POISON" and the skull and crossbones symbol for any highly toxic substance, or when required by the Regulations for a special hazardous substance (section 191.7(b)). A9. -The..--w--oirdMK"SPAOtCIrSMOU/Nr " for,1a1ll substances formerly subject to the Caustic Poison Act and so designated by the Regulations (section 191.109). S-W 003494 i 4 1 4 i < 10 10. Instructions for handling and storage of packages requiring special care in handling or storage. 11. The statement "Keep Out of Reach of Children" or its practical equivalent, or, if the article is intended for use by children and is not a banned hazardous substance, adequate directions for the protection of children from the hazardous substance therein. This information must be located prominently on the label. It must be in the English language, and in conspicuous and legible type in contrast with other printed matter on the label, by typography, layout or color. As amended by the Child Protection Act of 1966, action 2(n) of the Act defines tf term "label" as meaning "a d: ! <y of written, printed, or graj.: c matter upon die immediate container of any substance dr, in the case of an article which is unpackaged or is not packaged in an immediate container intended or suitable for delivery to the ultimate consumer, a display of such matter directly upon the article involved or upon a tag or other suitable material affixed thereto." Section 191.101 specifies also that size, placement, and conspicuousness of the required cautionary information appearing on or attached to unpackaged hazardous articles shall be the same as for packaged articles. When any accompanying literature (placard, pamphlet, booklet, book, sign, or other written printed, or graphic matter, or visual device) includes or bears any directions for use, it shall also bear all the cautionary information required by the Act In addition, all the information I required on the immediate containei is required also on the outside container or wrapper unless the immediate container label is easily legible through the outside container or wrapper. PREPARATION OF V^ARNINC LABELS In preparing the labels, the compilation of all available relevant information on the product is a necessary first step. An adequate knowledge of the toxidty of the material (obtained through^ laboratory tests or literature) and | data on physical and|chemical properties, human experience, packaging, and methods of handling and use of the product are also needed to prepare ai description of the hazards. Tests should be made on the product u'tseff as it will reach the consumer. I S-W 003495 l< PAGE INTENTIONALLY LEFT BLANK S-W 003496 DANGER! EXTREMELY FLAMMABLE HARMFUL OR FATAL IF SWALLOWED Oo not uao or star* near boat sparks, or op*n flam*. Avoid lopaatad or proioncod .contact with skin or braodiing ot vapor. It Mnlkwad, do not Indue* vomiting. Call physician immediately KHP OUT Of TNI MACH OF CHILDREN Section 191.101 of the Regulations rectangle with or without a spells out requirements fpr location borderline and by use of suitable of the warning and other contrast with the background protective information, size and by typography or color or both style of type for the various to emphasize the signal word, thef^ required statements, and other statement of principal hazard or details of label design, contrast, etc hazards, and instructions to read carefully other cautions placed elsewhere on the label. ARRANGEMENT OF REQUIRED 4. Statement of principal hazard or INFORMATION hazards (such as "VAPOR To comply with the Regulations, HARMFUL," "FLAMMABLE," certain required information must "CAUSES 8URNS," etc) shall appear on the main panel appear on the main panel in (normally the front panel) of the capital letters of not less than label, and within the borders of 12 a rectangle, with or without a 12-point type, unless there isinsufficient label space to borderline, in the type size, and accommodate that size type. In style specified below: such event the type size may be 1. Signal words (DANGER, made smaller but no smaller than WARNING, or CAUTION) must appear on the main panel in capital necessary and never less than 6-point type. letters, and shall be of a size bearing 5. The balance of the required a reasonable relationship to the cautionary information may appear other type on this main panel, but on the back or side panel of the shall not be less than 18-point label provided the main panel type unless the label space on the container is too small to bears an additional statement -such as "Read carefully other accommodate such type size. In no cautions on ------------- panel." event shall the size be smaller than This and all other required 6-point type. 2. The skull and crossbones symbol must be included in conjunction with the word "POISON" on the label of "highly toxic" substances as well as on the label of products containing 4% by weight or more of methyl alcohol, 5% by weight or mote of benzene, or carbon information shall bear a reasonable relationship to other graphic material on the panel involved ^ and shall be no smaller than 10-point type unless there is insufficient label space to accommodate that size type. In such event, the type size may be made smaller but no smaller than tetrachloride in any amount This information need not appear on the main panel. The word "POISON" is required for the caustic poison substances named in Section 191.109 and should appear in this case on the main panel, because it serves as the signal word. 3. The required prominence shall 6-point type unless an exemption has been granted 6. For articles not sold in packaged form, the necessary warnings may appear on the article itself, or, if this is not possible, the warnings must be placed on a sticker or tag securely fastened to the article The tag or be achieved by placement within the borders of a square or S-H 003498 *. BLEACWIRWK CAUTION ir r it .ANT Rood corefully cautions on bo:k panel Contains sodium hypochlorite Do not mix with acids or other household chemicals Avoid contact with dd^syos. and other mucous In ease of contact with eyas, flush thorouchiy with water If swaliowod, give. 1 or 2 glaasas of water or milk and call physician immediately. KW OUT Of THE MACH OF CHILMCM S-W 003499 S"w 003500 PERMANENT ANTIFREEZE" WARNING HARMFUL OR FATAL IF SWALLOWED Read carefully cautions on bock panel Do not drink antifreeae or solution If swallowed, indues vomiting immediately Call physician Ethylene glycol beae Do not stoie in opened or unlabeled containers KEEP OUT OP REACH OP CHILDREN S~W 003501 sticker must be attached securely enough to carry through distribution and merchandising to the ultimate purchaser or user. STATEMENT OF HAZARDS There are many products which present more than one type of hazard, in which case appropriate statements of each must be included in the label. The following are examples, but there are numerous descriptive phrases which can be used: MAY BE FATAL IF SWALLOWED EXTREMELY FLAMMABLE CAUSES 8URNS VAPOR HARMFUL HARMFUL IF SWALLOWED CONTENTS UNDER PRESSURE STATEMENT OF PRECAUTIONARY MEASURES A statement of precautionary measures is intended to supplement the statement of hazards by setting forth briefly measures to be taken to avoid injury or damage from the stated hazards. Examples are: Avoid contact with eyes and prolonged contact with skin Avoid breathing dust (or vapors) Do not take internally Use only in a well ventilated area CONDENSATION OF LABEL INFORMATION Statements such as "Do not take internally" may not be necessary where the precautionary measure to be followed is obvious (for example, when a product is labeled "POISON" or the statement of hazards contains the words "MAY BE FATAL IF SWALLOWED"). However, the instruction may be desirable if the name, appearance, use, or other <1 characteristics of the article are likely to result in its being taken orally through accident or mistaken identity. FIRST-AID INSTRUCTIONS IN CASE OF INGESTION, CONTACT, OR OTHER EXPOSURE While the primary purpose of a warning label is to prevent personal injury or damage, instructions to be followed in case of accidental contact or exposure are required where the results may be injurious, where immediate treatment is highly desirable, 6 and where simple remedial * measures may be taken safely by nonprofessional persons before medical assistance is available. Instructions should be given in terms of recognized first-aid procedures based on simple methods and commonly available materials. Competent medical advice must be sought in preparing first-aid instruc- S-W 003502 tions. In many cases the statement "Call a Physician Immediately" should be included. HANDLING AND STORAGE INSTRUCTIONS The requirement for handling and storage instructions, if needed, on the label reduces the hazards inherent in certain products. The following are examples: Keep away from heat and open flame Keep container closed when not in use Do not allow water to get into container To prevent accidents, rinse empty container before discarding. (For pressurized containers) Do not puncture or incinerate can. Oo not expose to heat or store at temperatures above 120 degrees Fahrenheit EXAMPLES ^ACCEPTABLE LABEL STATEMENTS The following are examples of wording which the Food and Drug Administration has accepted as meeting the requirements of the Act for particular products, where arrangement, type size and style, and degree of conspicuousness are . met These illustrations are reproduced only for information and general guidelines, and not as approved labels for specific products. Any manufacturer may obtain FDA comment on a proposed label or labels (or representative labels, where many different products are involved) by writing to the Food and Drug Administration. The manufacturer should furnish: (1) complete labeling or proposed labeling, which may be in draft form; (2) complete quantitative formula, in exact chemical nomenclature rather than trade names; (3) adequate clinical, pharma cological, toxicological, physica and chemical data, and other ( relevant information such as complaints of injuries resulting from the product's use, or other evidence that would furnish human experience data. The Food and Drug Admihistratic cannot conduct toxicity studies for the purpose of advising manufacturers whether proposed labels are satisfactory. Responsibility for accumulating whatever information is needed in deciding whether a label complies with the law rests with the sponsor of the article. In 1966, Congress enacted the Fair Packaging and Labeling Act (FPIA) giving the Federal Trade Commission responsibility for regulating certain labeling and packaging practices for various consumer commodities other than foods, drugs, cosmetics and devices. Since many consumer commodities classified as hazardou: substances will come within the Federal Trade Commission's jurisdiction under FPIA, before having new labels printed you may wish to consult with that agency regarding the adequacy of your labels under that relatively recent law. S-W 003504 Enforcement Procedures and Penalties The Act places in the hands of the manufacturer, packer, or distributor, the responsibility for marketing a properly labeled and otherwise legal article. The Food and Drug Administration is always glad to assist a firm or group in achieving voluntary compliance. However, regulatory and enforcement procedures are provided in the law, if needed. The Act authorizes FDA inspectors to inspect factories, warehouses, and other establishments, where products subject to the Federal Hazardous Substances Act are manufactured, processed, packed, or held for, or after, introduction into interstate commerce, and vehicles used for interstate transportation. The inspectors may inspect, at reasonable times and within reasonable limits and in a reasonable manner, the establish ment or vehicle and all pertinent equipment, finished and unfinished materials, and labeling; and may obtain packaged and unpackaged products, subject to the Act and labeling. The inspector will furnish the owner, operator; or agent in charge, with a written notice at the beginning of the inspection, and if he takes samples during the inspection, he will give a receipt for them. If an analysis is made of any sample taken during an inspection, a copy of the results of the analysis will be furnished to the owner, operator, or agent in charge. Inspectors may also collect samples of products from ware houses or stores or at any point in interstate commerce; " Prohibited acts under the Federal Hazardous Substances Act are listed in section (4) of the Act 4 They include (but this list is not ^ inclusive}: (1) Introduction or delivery for introduction into interstate commerce of any misbranded hazardous substance or banned hazardous substance; (2) alteration, multilation, or other change to the label of or the substance itself, while the S-W 003506 article is in interstate commerce or held for sale after shipment in interstate commerce, that re- i in the hazardous sub- ce being a misbranded hazardous substance or banned hazardous substance; (3) failure to permit factory inspection as authorized, or sample collection, or copying of any record as authorized; (4) the giving of a false .guarantee; (5) introduction or delivery for introduction into, or receipt in, interstate commerce of a hazardous substance in a re used food, drug, or cosmetic container, which reuse results in the hazardous substance being a misbranded hazardous substance. If evidence of a violation is found during an inspection, or as a result of examination of any sample, the following actions may result: Seizure of the vio/ative shipment; Criminal prosecution; or. Infunction. sel^t o f vioiATive s h ipmen t If a shipment is seized, the owner or his agent would have three choices: (1) He may deny the violation as charged and the case may be contested on its merits in a Federal court (2) He may admit the violation and ask the court for permission to post bond and relabel the product to comply with the law. The product is then released for relabeling under the super vision of the Food and Drug Administration. After the re labeling is satisfactorily com pleted and the supervisory costs paid, the product will be re leased and the bond money re turned. (3) He may do nothing. In this case, the product will be con demned by default and de stroyed, or otherwise disposed of as determined by the court CRIMINAL PROSECUTION In the event of criminal prosecution, whether a violative product is seized or not, the person (*) who ships it in interstate commerce, or who commits or causes to be committed any of the other pro hibited acts, may be subject to trial in a Federal court. If prosecu tion is instituted and the defendent pleads guilty, or is found guilty after trial, he may be punished by a fine of not more than $500, or imprisonment for not more than 90 days, or both, for each separate offense. For offenses committed with intent to defraud or mislead-- or for second and subsequent -offenses, the penalty^may be imprisonment for not more than one year, or a fine of not more than $3,000, or both. INJUNCTION Injunction proceedings to restrain him from the commission of further violations also may be instituted against any person who is found shipping a violative product in interstate commerce, or committing or causing to be committed any of the other prohibited acts. () "Person" is defined in the Act as including an individual, partner ship, corporation, and association. Where an injunction is entered, the failure of the person enjoined to comply with the terms of the injunction may subject him to criminal contempt proceedings. S-W 003507 Further Information and Source Material July-August and December-January issues. Subscriptions, may be ordered from the Superintendent of Documents, U.S. Government Prints ing Office, Washington, D.C. 20403 at $5.50 a year. OFFICIAL FOOD AND DROC ADMINISTRATION PUBLICATIONS Single copies of the publications listed below are available at no charge from the Food and-Drug Administration, Washington, D.C. 22 20204, and at FDA district offices. * Hazardous Substances Regula tions (Part 191, Title 21, CFR) (in looseleaf form; bound MAILING LIST copies available from GPO) * Petroleum Products and the Manufacturers of products subject to the Act, and others with an interest in hazardous substances, are invited to submit a request for placement on the Federal Hazardous Substances^ Act mailing list Those on the list receive, free of charge, reprints of amend ments to Part 191, Tide 21, CFR, in looseleaf form. In addition, reprints of policy statements, press releases, and other publications, to help manufacturers and others in their voluntary compliance program, are furnished. Address your request to: Distribution and Mailing Unit (CA-217) Food and Drug Administration Washington, D.C 20204 FDA Papers, the official magazine of the Food and Drug Administration, contains current information and explanation of policy of major significance to the regulated industries. Each issue includes Notices of Judgement and enforcement actions. It is published ten times a year, with combined Law--FDA Publication No. 17 The publications listed below may be ordered from the Superin tendent of Documents, Government Printing Office, Washington, D.C 20402. Federal Hazardous Substances Act Federal Food, Drug, and Cosmetic Act General Regulations for Enforce ment of the FDC Act FDA Pub. No. 2 Requirements of the FDC Act The Federal Register publishes the rules and regulations of the various departments of the Federal Government, including the amendments to Part 191, Title 21, CFR. As noted under a previous section ("Mailing List"), FDA issues free reprints of these amendments; however, those wish ing immediate notification of new or amended regulations should subscribe to the Federal Register since duplication of the reprints requires additional time. Sub scriptions at $15 per year should be placed with the Superintendent of Documents S-W 003508 INFORMATION FROM OTHER US. 'jf^ERNMENT AGENCIES ilradditional information con cerning other Federal laws and reg ulations affecting hazardous products, write to the following agencies (all are Washington, D.G): United States Department of Agriculture Agricultural Research Service Pesticide Regulation Division (for Federal Insecticide, Fungicide, and Rodentitide Act) Washington, D.C 20250 Department of Transportation Hazardous Materials Regula tions Board (for regulations for the shipment and trans portation of hazardous materials) Washington, D.C 20553 Regulations for the Transporta tion of Explosives and Other Dangerous Articles (Tide 49, CFR, Parts 171-191) Federal Aviation Agency Flight Standards Service Attn: F.S. 400 (for Regulations for the Transportation of ^Dangerous Articles and Magfpedzed Materials (Tide 14, CFR, Part 103) Washington, D.C 20553 Atomic Energy Commission Attn: Division of Materials Licensing (for Standards for Protection Against Radiation, Licensing of Byproduct Ma terial, Licensing of Source Material, Special Nudear Ma terial, Regulations to Protect Against Accidental Conditions of Criticality in the Shipment of Special Nudear Material; all are Title 10. CFR) Washington, O.C 20545 Post Office Department Bureau of Operations Classification & Special Services Division Washington, D.C 20260 Federal Trade Commission Bureau of Deceptive Practices (for Flammable Fabrics Act Fair Packaging and Labeling Act, and the Federal Trade Commission Act) Washington, D.C 20580 INFORMATION FROM NONFEDERAL GOVERNMENT AGENCIES A number of States and cities have enacted taws governing the labeling of hazardous substances within their jurisdiction. Interested persons may write to the appropriate State agencies for information concern ing these laws. It should be noted, however, that under the amendments to the Federal Hazardous Substances Act by the Child Protection Act of 1966, Congress pre-empted all laws of the States and political sub divisions relating to precautionary labeling of substances or artides intended or suitable for household use. In effect then all labeling requirements are uniform throughout the 50 States, insofar as meeting the minimum require ments of the Federal Hazardous Substances Act Any State, or political subdivision, could impose additional requirements; i.e., a State could, at its discretion, ban the sale of a product which would not be banned under the Federal Hazardous Substances Act if properly labeled. S-W 003509 a 24 STATt California Colorado Connecticut Illinois CNfOKtMtNT ACCNCY Bureau of Food and Drug Inspection State Department of Public Health 2151 Berkeley Way Berkeley, California 9470* Oivision of Sanitation Su m Department of Public Health 4210 fast 11th Avenue Denver, Colorado 60220 State Department of Consumer Protection State Office Building 16S Capitol Avenue Hartford, Connecticut 06115 Bureau of Hazardous Substances and Poison Control Oivision of Preventive Medicine State Department of Public Health State Office Building Springfield. Illinois 62706 Indiana Registration and licensing Sec Oivision of Food and Drugs Indiana State Board of Health 1330 W. Michigan Street - Indianapolis,; Indiana 46207 Kansas Food and Drug Oivision State Board of Health Stale Office Building Topeka. Kansas 66612 Kentucky Food and Drag Program Oivision of Chvironmentai Hea 273 Cast Main Street Frankfort. Kentucky 40601 Maine Division of (consumer Protect! State Department of Agricultui State House \ [ Augusta. Maine10{ 4330 Massachusetts Michigan Division of Food and Drugs Stale Department^of Public H S27 Stole House ... ^ J 02133 Inspection Brvmon Stole Department W Agricultui lewis Cass Building laming, Michigan *6913 Minnesota Division of Agronon y Services Stott Departnfsnt of Agncuitun State Office BeUdtoi Si Paul, Minnleota 55101 S-W 003510 New Hampshire Bureau of Food and Chemistry State Department of Health and Welfare 61 S. Spring Street Concord. New Hampshire 03303 Bureau of Food ond Drugs Health-Agriculture Building John Fitch Plaza P.O. Bo* 1540 Trenton, New lersey 0B6Q7 North Dakota . State laboratories Department 105 North Seventh Street lock Box 900 Bismarck. North Oakota 5S501 Oivtsion of Sanitation Bureau of Environmental Health State Departments Building Columbus. Ohio 43215 Food and Orug Division State Department of Health 3400 North Eastern Oklahoma City. Oklahoma 73105 Division of Food and Drugs Sute Department of Agriculture Ellington Agriculture Center Melrose Station Nashville. Tennessee 37204 Vermont Virginia Wisconsin Division of Food and Drugs State Department of Health Ausun, Texas 78756 State Department of Health 115 Colchester Avenue Burlington. Vermont 05402 Division of Regulatory Services Department of Agriculture and .^-''-Commerce203 N. Governor Street Richmond, Virginia 23219 State Department of Agriculture Division of Oairy, Food and Trade Hill Farms State Office Building 4802 Shebovgan Avenue Madison, Wisconsin 53702 C/TV ENFORCEMENT AGENCY New York City Bureau of Food and Drugs New York City Department of Health 12S Worth Street New York. New York 10013 003511