Document B8G9NxK4E5RyLeOJXb3xbQDbE

t CPORNOSDUUMCETRS,HERAALDTIHATAIONND PRODUCT HAZARDS - CHEMICALS. ELECTRONIC0 Vol. 1 Of THE LEGISLATION OF PRODUCT SAFETY Samuel S. Epstein and Richard D. Grundy, editors Tr*AH*MI1 If*** HONS 205468 Dedicated by Samuel S. Epstein to his children: Hark, Julian, and Boily Copyright <) 197^ by The Massachusetts Institute of Technology All rights reserved. Ho part of this book may be reproduced i any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the publisher. This hook was typed by Dorothy Linick. It was printed by Clark-Franklin-JCingston Press And bound by The Colonial Press, Inc. in the United States of America. Library of Congress Cataloging in Publication Data Epstein, Samuel S. Consumer Health and Product Hazards - Cnemicals, Electronic Products, Pad!ation {The legislation of product safety, v. 1] ' CONTESTS: v. 1. Chemicals, Electronic Products, Radiation 1. Hazardous Bubstances. 2. Product safety. T55-3.H3B67 601,'.7 7 **-99 5 ISM 0-262-05013-7 . HONS 205469 ^ | ^t-' i 10B :ent /.anl c les itural ives. shoes, ic ce in ts, lion s (?). and ils, .red eivable 'S jor.ic Led IttS, ganic of a tunately, impact cidcntal Only in 41 .rol i ?ds of ; and se of csent f I Polychlorinated Biphenyls Probably no other class of organic chemicals in industrial use core clearly illustrates the need for effective environmental control of industrial chemicals than the polychlorinated biphenyls (PCB's). While PCB's have a history of use (9) dating back to 1929, it was not until 1966 that they became suspect as videspread environmental contaminants. Since then, PC3's have been discovered as contaminants in food (lO), vildlife and fish (11), marine and fresh water, and in human tissues (12). They nov appear to be one of the most widely dispersed and abundant environmental contaminants. While it is clear that PCB's are widely dispersed in the environment, it is less clear how it happened. Given their wide application in Industry, the pathways through which they can reach the environment are numerous. Although no quantitative source data are available, the following appear to be the mort Important (13): open burning and incineration of industrial and municipal wastes; vaporization from paints, coatings, and plastics; municipal and industrial sewers; accidental spills; disposal of sewage sludge; and migration from surface coatings and packaging materials int: foods and feeds. It also is very likely that a significant enount of PCB's used in "closed" v-- HONS 205471 Qnjmdy, Velsbrod, Epstein systems such as capacitators, transformers, and hydraulic ay^tems have been released, either by inadvertent leakage from such devices, by disposal directly into sever systems, or by migration from land fills vhere spent devices containing PCB's haVe been buried. | It has been estimated that over the past Uo years about 30,000 tons of PCB's have been lost to the atmosphere, 60,000 tohs to vater systems, and 300,000 tons to dumps (lit). These estimates are crude, and a recent report adds an element of confusion. It has recently been suggested that DDT can be converted to PCB's by irradiation with ultraviolet light of wavelengths found in the lover atmosphere (15)- If these observations are confirmed, estimates of the total amount of environmental PCB's may be drastically changed. Because of their unusual properties -- stability at high temperature, nonflammability, cooling and insulating capacity -- pqB's are now alleged to be essential or (at least for the tljme being) nonreplaceable in the electrical industry. (Although the silicones do appear to be possible substitutes.) This fact, together with a lack of adequate biological and ecological information about PCB's, has made dealing with them on an ad hoc basis even more difficult. Their value to the electrical industry can be detailed at length, while the "externalized" costs of those uses, especially in terms of human health, is at present unclear. The most extensive adverse human experience with PCB's began in Japan (l6). In October 1968 an outbreak of a peculiar B^cin disease known as chloracne was reported in Fukuoka Prefecture. Shortly after, twenty other prefectures in western Japan reported the disease and by August 1971 some 1,057 cases had been reported. The initial signs and symptoms of the disease are swelling ojf the upper eyelids and eye discharge, acneiform skin eruptions, follicular accentuation and skin pigmentation, disturbances of digestive functions, and numbness and other neurological disorders. No sex differences in the distribution o'f the disease were noted, but it seemed to occur within particular families. For instance, 325 patients examined in I^ikuoka Prefecture between October 1968 and January 19^9 belonged to 112 families. ' Soon after the epidemic became evident, a study group Composed of staff members of various faculties at the University If Kyushu was formed to determine the cause of the epidemic and to find means to control it. A thorough case study was undertaken of 121 patients and 121 healthy controls, matched by age and sex, in which individuals were asked 60 questions HONS 205472 f1 ir jn sity and i(B ijilit Toxic Substances 111 concerning their occupation, medical backgrounds, health status, diet!;, and other personal habits. It vas discovered that the only significant difference between the patient's and the control's habits was the fact that a greater number of patients reported eating fried foods or tempura nearly every day. A further test matched 69 households with patients against 207 households without patients; 96 percent of the patients' households reported using a brand of rice oil designated, as "K rice oil," while only 31 percent of the control households reported such use. It was eventually established that the source of the disease (now called Yusho) was a supply of rice oil produced by a| single company and shipped between February 7 and 10, 1963. The oil had become contaminated with as much as 3,000 ppm jof FCB's during the process of heating the oil at reduced pressure to remove unwanted odors. It is believed that the PCB'|S leaked from the heating pipe and contaminated the oil. the summer of 1970, a mass clinical exsmlnation of Yusho patients was conducted, About 50 percent of the patients showed some improvement, despite the fact that no cure is Known for the!disease; the remaining 50 percent of the patients showed no improvement, with 10 percent of this group apparently deteriorating. Ironically, six months before the outbreak of Yusho, parts of western Japan were affected by an outbreak of a disease in chickens as a result of which tiOO.OOO birds died. This outbreak was eventually traced to feeds in which "dark oil" was used as an Ingredient. It was further discovered that the "da|?k oil," which was contaminated with 1,300 ppm of PCB's, was purchased between February 6 and 27 from the same company that produced K rice oil. (While the United States fortunately has been spared the suffering associated with a massive outbreak of Yusho, there havje been numerous cases paralleling the outbreak in Japanese chickens. Some of these incidents ere rather bizarre and clearly Indicate the need for overall regulation of toxic materials. jin one case, the state of New York placed three counties under quarantine when surveillance data collected by the Campbell Soup Company indicated excessive PCB levels in chickens raised in those counties (13). The federal Food and Drug Administration (FDA) advised the State and the United States Department of Agriculture (USDA) that the distribution of|poultry containing less than 5 ppm of PCB's would be acceptable, implying of course that anything exceeding that leVel would be subject to confiscation. Apparently all parties. i i I ! ffrvndy. Woisbrod. Epstein ii? ;rt.ra re rra s a including the producers, agreed to this arrangement. On the basis of subsequent analyses performed by the State of New Yorjk, ll0,t*50 chickens had to be slaughtered. It is interesting to speculate on the outcome of the situation had the producers beeh less cooperative. It is certain that the rationale for allowing PCB concentrations of no more than 5 ppm in chickens would be difficult to defend on scientific grounds. It is Just as certain that defending the harmlessness of this level of PCB's would be equally difficult. The source of PCB's in this case was thought to be plastic bakery vrappers, as stale bakery goods were ground up, wrappers and all, and used as chicken feed. In another case (13), an estimated 12,000 tons of fish meal were contaminated with PCB's by a leaky heating system in a fish-meal pasteurization plant at Wilmington, North Carolina, between April and July of 1971- Of this, about 2,000 tons were recalled from the market. Samples of the meal indicated PCB contamination ranging from lh to 30 pptn. Not only did this result in the recall of fish meal, but It also affected the hatcjhability of eggs in at least one large poultry operation that) used the meal as a poultry ration. Furthermore, one broiler chicken producer had to destroy 88,000 birds, also the {result of contaminated rations. In these incidents, all actipns were based on the FDA's 5 ppm guideline. Further incidents involved poultry in Oklahoma, Minnesota, Mississippi, and California; milk in West Virginia, Ohio, Florida and Georgia; and meat meal in Illinois, The source'of milk contamination in Ohio, Florida, and Georgia was thought to b|e from a FCB-containing sealant used in silos (13). Because of these unexpected incidents, the FDA has initiated an extensive national surveillance program to monitor animal feeds and milk on a state-by-state basis. Aside from the direct contamination of consumer products with PCB's, there are the longer-range environmental effects. Because of the stability of PCB's, even a total shutdown of all Sources of environmental contamination would not result in an immediate decrease in PCB levels. Here the picture is even leas clear than it is with immediate human health problems. While laboratory studies indicate a number of potentially adverse effects of PCB's, such as microsomal enzyme induction, estrogenic activity, and immunosuppression (17), there Is a noteworthy sparcity of toxicological data; moreover, the eventual effect of even the present burdens of PCB's on the environment is far from clear. ' Ii^ light of the aforementioned experiences, the Monsanto Chemical Company, the sole producer of PCB's In the United M0NS 205474 ijjUiiippwnMI1 WJ IJI "J F'y k tr ii? 16 ota, ion, a ie Toxic Substances U3 States, has agreed to voluntarily limit the distribution of PCB'b to those uses which are considered "closed systems." povever, PCB's ore now also manufactured in Great Britain, '/ranee, Germany, the USSR, Japan, Spain, Italy, and E zechoslovakia. What is clear, as will be subsequently discussed, is that existing federal authority is inadequate to restricting more ' CB's from entering the environment. Additionally, the federal uthority cannot at present control the importation of PCB's anufactured in foreign countries. The result is that in the nited States there exists an almost universal presence of // 'CB's in the environment which, under existing authority, can >e controlled only on a piecemeal basis. 'hthalic Acid Esters Another group of chemicals to gain N ecent attention of environmentalists (18) are the phthalic ' icid esters (PAE's). Attention was first drawn to PAE's when, 5following a widely publicized report in 1970, they were found ^s a contaminant in whole blood stored in polyvinyl chloride ransfusion bags (19). Before long, other scientists began to eport the occurrence of PAE's in a diversity of environmental Samples: water taken from the Charles River in Massachusetts (20), fish tissue from the Great Lakes (21), and heart tissue lYom cows (22). The mechanism by which PAE's enter the environment is unclear. A very small amount of the total production is applied directly to the land in the form of pesticide carriers; evaporation from plastics is another source; and some PAE's ai*e probably released during the manufacturing process. A number of reports indicate that some PAE* s also are produced naturally by a few species of plants, fungi, and bacteria, T}iese reports, however, are now open to question since ntamination of laboratory equipment during analysis has been imnon. Phthalates are incorporated into polyvinyl plastics to give e end product its desired pliability. Oddly, however, the asticizer does not actually combine chemically with the -lyaer resin, but Simply acts to "lubricate" the polymer lecules in such a way as to allow them to be flexible. The asticizer materials can sometimes account for as much as percent of the entire weight of a plastic product# These plithalate plasticizers are able to migrate from the plastic ir[to either the air or a surrounding liquid. j'PAE's are one of the most widely used plasticizers. In 1968, there were at least 10 different phthalate compounds in production, totalling 715 million pounds (23). This is noc tdtal production, however, because information about many MQN5 205475 lilt phthalate compounds Is proprietary information. Therefore the actual substances are not identified; these unidentified PAE's account for another 125 million pounds annually (23). [ The PAE's generally have been found to be of very low t&xicity, when administered orally or by injection. When some eight phthalates were examined (2lt), their acute LD50, when injected into the peritoneum, ranged from I.58 grams per kilogram of mouse body weight to lit.19 grams per kilogram. In other words, by this route these compounds were virtually nontoxic from the standpoint of immediate effects. In the same study, however, some observations were made on more sensitive indices of subacute toxicity (). A factor complicating toxicological research on phthalates has been the difficulty in their precise chemical characterization (25)* It was found, on careful analysis, that besides commercially prepared medical-grade plasticizer [pi(2-ethylhexyl)phthalate (DHEPj, several other relsted chemicals also were found in blood stored in plagtic bags (25). The other contaminating chemicals were thought to be closely related compounds (homologues) of the plasticizer that became incorporated into the product during the production process. Most of the homologues were about as toxic as their plasticizing relatives. Special note was made of the fact that specially synthesized pure di-n-decyl phthalate was not toxic, while a commercial preparation was extremely toxic to mice. In conclusion, the authors stated (25) that: "A pure plasticizer may have no demonstrable toxic response, but the presence of related homologues and isomers could add toxic potential to the plasticizer. To this possibility one must also include potential toxic effects from degradation products present or forming in the plasticizer during manufacture of a plastic device, or occurring after the device had been stored under various conditions for undetermined amounts of time." More recent experiments have indicated that some PAE's were teratogenic (causing birth defects) following administration to laboratory animals (26). Eight different PAE compounds were injected into pregnant rats (at doses of 0,3 to 10 milliliters per kilogram of body weight) on the fifth, tenth, an& fifteenth day of gestation. Among the effects induced were fetal death, decreased fetal size, and abnormalities such as twisted hind ldgs, fused ribs, and absence of eyes or tails. Two PAE compounds were also tested for mutagenic (causing genetic damage) effects in male mice (26). A single dose of j yugmipfiMic HONS 205476 Toxic Substances JL11 DHEP|Vas Injected into male mice prior to mating. Litters from females mated to DHEP-treated males shoved a significantly higher percentage of fetal deaths at all dosages tested. These results indicate that PAE's induce dominant lethal mutations. Here again, as with PCB's, is a case in vhich a group of chemicals have become videly dispersed in the total environment before they were recognized as a potential hazard. Only minimal control has been exercised over the use of PAE's and those controls only apply to situations where the material comei in direct contact with food (27). It is likely that exposures from other sources, especially consumer products made from]polyvinyl chloride plastics, are of much greater significance. Automobiles, for example, whose interiors are lined with plasticized materials, are probably a major source of inhaled PAE's and data on inhalation exposures are absent from [the available toxicological literature. Freons Another class of synthetic organic chemicals, in widespread use before it came under careful examination, is the fluoroalkanes (Freons). These chemicals are almost universally used as the propellant in aerosol products. Yet they]are now under strong suspicion. Since the 1950's, there has been a steady increase in the numbers of sudden deaths among[ asthmatics that is closely related to the increased use of pressurized aerosol bronchodilators. At present, the precise cause of these sudden deaths is unclear, but evidence is accumulating that they may be the result of cardiac arrhythmias (20). A recent FT)A report indicated that 11 sudden deathjs have been associated with the use of one of these products (29)* MONS 205477