Document 2Jadq8gp1jGmrNzK7YEbKLnVp

Circular Bulletin dept. President Date January 7, 1963 No. 10 Subjects Federal Hazardous Substances Labeling Act I \ i f i [ } j ; j | [ t | fj ^( 1. As you are no doubt aware, the Federal Hazardous Substances Labeling Act became effective last year. The purpose of this Act is to assure that all hazardous substances* Intended or suitable for household use have proper labeling. The Food & Drug Administration, whose regulations Issued under the Act .become fully effective February 1, 1963, has been given the authority to Inspect manufacturing and distribution facilities and equipment as an aid in enforcing the law. 2. Your cooperation with the Inspectors will facilitate these inspections, and to avoid disruption of work schedules, you may wish to plan in advance the procedures to be followed when an inspection is requested. Under the Act, the FDA inspectors, upon-presenting identifying credentials and a written notice to the Superintendent, Manager or authorized Company representative in charge of the facility, are authorized to: a) Enter at reasonable times, any facility which manufactures, processes, packages, stores or transports hazardous substances; , b) Inspect at reasonable times and within reasonable limits and in a reasonable manner, such facility, and all per tinent equipment, finished and unfinished materials, labeling and packaging; and c) Obtain samples of any such materials, packages or labels. 3. If samples are taken, the inspector should be requested to give a receipt for each one. If an analysis is made of any such sample, a copy of the results is required by the Act to be furnished promptly to the Superintendent, Manager or authorized representative in charge of the facility. In ' general, the inspectors will be interested in determining the composition of the various materials used in the manufacture * - Hazardous Substances are defined as those that are toxic, corrosive, an Irritant, a strong sensitizer (allergenic), or that'generate pressure through decomposition, heat or otherwise, if such substance may cause substantial injury or illness during any customary or foreseeable handling or use. Including foreseeable ingestion by children. * T . P T D . IN U.B.A. SUGGESTED RETENTION l~l D*$troj Afur Noting f ? Dmtmy A/tor Complying Dtttroy Afttr SRttnin Rntnrn With C, ASI 00002345 AcJOJ * 2. of products and whether the labels in use for the various finished products meet the requirements of the Act. The scope of the Inspection is a limited one and does not extent to files on formulas, research data, complaints, personnel records, patent Information, production and sales figures, and products which are not hazardous substances, etc. 4. Please communicate with the Morristown Executives having jurisdiction over your location: a) If you have advance notice of an inspection, since we may wish to have Morristown personnel present. b) If you believe an inspector is exceeding his authority (but also ask him for a written request specifying the information wanted). c) If you have any questions concerning the Act, whether now or later. d) Furnish report in duplicate of each inspection including identification of inspector, the scope of the inspection, what labels and samples were supplied, and any information gained from the inspector's remarks. If obtainable, furnish copies or photocopies of forms and other papers used. 5. Jurisdictional Executive will transmit copy of report of inspection to Legal Department and refer other pertinent matters to them when legal interpretation or assistance is required. FJF:rr cc: Officers Department Heads President Attachment - Abstracts from Federal Hazardous Substances Labeling Act ASI 00002346