INDUSTRY
& B U S I N ESS
Industry Objects to FDA Proposals Chemical spokesmen feel that proposed regulations go beyond intent of new federal Hazardous Substances Labeling Act Industry groups are objecting strongly to parts of the regulations proposed by the Food and Drug Administration under the new federal Hazardous Substances Labeling Act. It's possible, in fact, that some groups may call for public hearings on the regulations, which were published April 29 in the Federal Register. Deadline for filing comments on the regulations is June 28. The basis of most objections is that industry people feel that the regulations, as proposed, are "substantive" and go far beyond the intent of the law. FDA, on the other hand, says they are "interpretive" and "procedural." But FDA Commissioner George P. Larrick says, "Responsible industry groups supported enactment of this law and we are confident they will likewise assist us in working out practicable regulations and in promoting voluntary compliance to accomplish the purposes of the law. We not only welcome but solicit such assistance and cooperation." The Manufacturing Chemists' Association, which strongly supported the act itself, has written to each of its member companies, pointing out major objections to the regulations and suggesting that they might wish to file individual comments in addition to the comments that MCA will file. Both MCA and the Chemical Specialties Manufacturers Association have written to FDA objecting to a booklet issued by FDA that explains the law and the proposed regulations. MCA called the booklet "premature," and suggested that FDA might wish to consider limiting its circulation. CSMA suggested that it ought to be withdrawn entirely. Overlabeling. If the proposed regulations are put into effect, a great many household products—cleaners, polishes, paints, to name just a f e w will have to carry such warning signs as "danger-poison" in letters as big as the brand name—plus a skull and 36
C&EN
JUNE
19,
1961
FDA's George P. Larrick We welcome industry assistance
crossbones symbol—in a conspicuous place on the main panel of the container. Many people in industry feel that such provisions of the regulations would result in overlabeling, and that the constant sight of these warnings on products which are relatively harmless when used in the normal way may cause people to disregard similar warnings on truly dangerous products, such as lye or strong acids. The proposed regulations say that the signal words in the warning (for example, "danger-poison") must be in 30-point type, or, if the label is too small for this, that the type shall be at least as large as any other type on the label. The signal words are to be followed by other information on proper conditions for use and emergency treatment in case the product is accidentally swallowed or otherwise misused. "It is incomprehensible that the warning label should not be smaller than the largest type on the label," objects one chemical company spokesman. "It is traditional and common custom for the trade name of the product to be in extremely large letters to attract the eye of the prospective cus-
tomer. Purchasers expect the main panel to contain statements exaggerating the value of the product, and look to the back label for directions about using the product." MCA also feels that the term "container intended or suitable for household use" is too broad, and that many commercial and industrial products will be classified as household products. The definition includes containers which may be brought into any place where people dwell, or in or around a related building such as a garage, carport, barn, or storage shed. At present the chemical industry generally follows a set of uniform principles of precautionary labeling for commercial and industrial products worked out by the MCA labels and precautionary information committee and in use since 1944. Many people also believe that the test methods set up to determine whether a product is an* irritant, a corrosive, or flammable are objectionable in certain respects and are too rigidly defined. They think that the FDA should recognize alternative methods if they give substantially equivalent results. The levels of toxicity set up are also questioned. Premature. Considerable controversy has developed concerning a booklet published by FDA on how to comply with the new act. Although FDA says the booklet is a "preliminary guide" and that final regulations will differ from the proposed ones, CSMA and MCA both feel that the booklet may cause confusion among people who are unsophisticated in precautionary labeling. The booklet is in part based upon the proposed regulations and includes illustrations of labels which would comply with such regulations. FDA officials point out that a great many industry groups never have had to concern themselves with the problem of hazardous labeling, and the law—including penalty provisions for some substances—is already in effect, even if the regulations are not. The FDA is only interested in helping to answer the questions of people who have to comply with the new law. Before preparing the booklet it circularized about 25 industry groups, asking if they wanted copies. About 16 replied, and asked for a total of 6500 copies. On this basis, 10,000 booklets were printed, and nearly all of these have been distributed in response to the requests of these groups.
