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(yd- 7l^M- to Dangerous Properties of Industrial Materials Report N. Irving Sax Editor-in-Chief Dr. H. E. Stokinger, Ph.D. Former Chairman TLV Committee Liaison member of Amer. Stds. Assn. Committee Benjamin Feiner Environmental Consultant Dr. John H. Harley, Ph.D. Former Director Environmental Measurements Lab. Dep't of Energy Dr. Nick Hild, Ph.D. Manager Environmental Affairs Discrete Div. Motorola Inc. Phoenix, Ariz. Dr. Michael F. Jacobson, Ph.D. Executive Director Center for Science in the Public Interest Dr. Thomas J. Haley, Ph.D. . Assistant to the Director National Center for Toxicological Research Food and Drug Administration Richard J. Lewis, Sr. Editor-in-Chief . Registry of Toxic Effects of Chemical Substances NIOSH Dr. Jan C. Prager, Ph.D. Senior Scientist, Field Assessment Branch U.S. EPA Professor David Gordon Wilson, Ph.D. Prof. Mechanical Engineering Head, Systems and Design Div. MIT Cambridge, Mass. Editorial Staff: Managing Editor, Paula Birghenthal Assistant Editor, Edythe Capron Editorial Secretary, Joyce Phyllips = -- - - ' - DANGEROUS PROPERTIES OF INDUSTRIAL MATERIALS REPORT is published bi-monthly by Van Nostrand Reinhold Company Inc.. 135 West 50th Street. New York, N.Y. 10020. Annual subscription price is $96.00 in the U.S., $120.00 outside the U.S. Application to mail at second class is pending. New York, New York and additional mailing offices. Postmaster: Send address changes to Van Nostrand Reinhold Company Inc., 135 West 50th St., New York. N.Y. 10020. Address all editorial correspondence to Editor-in-chief, N. Irving Sax, 7 Royal Palm Way. Boca Bayou Apt. #7-104. Boca Raton, Florida 33432, telephone (305) 391-1269. Direct subscription questions and orders to Rose Rivera ot Customer Service, Van Nostrand Relnhold Company, 135 West 50th Street, New York, N.Y. 10020. Direct Dial (212) 265-8700 ext. #119. Make checks payable lo Dangerous Properties of Industrial Materials Report. Annual subscription (nice is $96.00 in the U S.. $120.00 outside the U S. DANGEROUS PROPERTIES OF INDUSTRIAL MATERIALS REPORT is copyrighted ' 1983 by Van Nostrand Reinhold Company Inc. All Rights Reserved. Contents may only be reproduced or photocopied for a fee of two dollars, per page, per copy to be paid through the Copyright Clearance Center, Inc., 21 Congress Street, Salem, Massachusetts, 01970 CCC 0207/3777/83/$0.00/$1.00. Back issues available in print or microfiche through Van Nostrand Reinhold Company Inc. Volume 1 of this journal is available ex clusively from Allred Jaeger, Inc , 66 Austin Blvd., Commack, N.Y. 11725. In Japan, all Van Nostrand Reinhold journals are ordered exclusively through Maruzen Company. Ltd., Tokyo. The journal is also available through the following abstract services: Environ mental Information Center Inc. and Cambridge Scientific Abstracts. Production Staff: Acting Publisher, Willis C. Walker; Production Editor, M. Katherine Ryan: Editorial Assistant, Soraya Samii; Art Designer, Donni Gillies. Promotion Copywriter, Marianne Seidler; Senior Administrative Assistant, Rose M. Rivera; Publisher, Eugene M. Falken. EX P-1049 Page 1 of 16 PCB-ARCH-EXT0378197 FEATURES =------- ' 2 Strategies for Linking Technical Information Systems to Occupational Health Decisions, Part I. by Ciuylha A. Langlois, Ph.D. and Catherine F. Allen Rowlands, B.S. 8 Chemical Review: Theophylline by Thomas J. Haley 16 International Toxicity Update Bismuth Salts/Cadmium/Carbon Black Feedstock Oil/Carbon Disulphidc/Chlorobenzilate/ Cobalt/Dimethoate/Dioxins/Engine Oils. HAZARDOUS MATERIALS ----------------- - ------- r: ^ 29 Barium 31 Bar ium Cyanide 32 Beii/idinc 37 Bcn/oic Acid 40 |U'it/onii rile 42 I'd ric Cltlin ide 43 Ferric Sulfate. 1 lexahydrate 4S l eirons Sulfate, 1 leptahydrate 50 limit ine 53 Toimie Acid 5(> Bailie Acid 5X (ilyeeiol Ml (million (.5 1 lydra/ine (>S 1 lydrogen Sulfide 73 I'eiitaelilorophcnol 77 Phenol X4 Phosphoric Acid S7 I'hosplu'ious Oxychloride X9 Phosphorous Pentasulfide 91 Phosphorus, White-Red 93 Phosphorus Trichloride 95 Polychlorinated Biphenyls 101 Potassium Arsenate 103 Potassium Arsenitc |OC> lindecanol 107 /.iteoninm Potassium Fluoride 109 Zitconium Tetraehloride (Jail Tor Papers Papers arc invited tor review by the liditor and Fditorial Board. Please address all queries and cor respondences to the Uditor-in-Chiel. EX P-1049 Page 2 of 16 PCB-ARCH-EXT0378198 Gavtha A. Lunylois, Ph.l). Bryant College Smithfield. R.l. anil Catherine /'. Allen-Rowlands, B.S. Brown University Providence. R.l. IN I KODIK I ION The study of the occupational health environment re quites some know ledge and understanding of a number of basic scientific disciplines including biochemistry, physical chemistry, physiology, mathematics, engineer ing, pathology and toxicology, as well as some compre hension ot the non-scientific disciplines of law, business and socioeconomics. Occupational health problems must be counted as an important facet of public health today. Not only tire there obvious problems of accident and injury, but there is also ample evidence of long term deteriorative health effects. I lie Second I ask Force for Research Planning in F.nvironmental Health Science (lf)76) noted that there is clear evidence that "occupa tional hazards influence the development and progression of chronic degenerative disease." For some of these de generative diseases, the precipitation factor(s) may lie in the workplace as well. I he Task f orce also reported that "exposures to low levels of toxic agents may cause subclmical effects which are manifested in increased suseepti- EX P-1049 Page 3 of 16 PCB-ARCH-EXT0378199 bilily to infect ions diseases, psychiatric illnesses, and other non-occupational disease problems." and concluded that the extent of occupational related illness is probably still fin t her mulct estimated, since it is "known that cases ot classic occupational diseases are being missed because many physicians are not relating disease stales to occupa tional exposure. '' I ssenttally, occupational diseases resulting from expo sure to toxic chemicals may occur in any organ system, with an immediate response to substances such its carbon monoxide or hydrogen sulfide, or a delayed response, ranging trom overnight response to nitric oxide or a twenty year delay in tespouse to asbestos exposure (( hristeusen. 197b). Health el feels may occur trom a single, acute exposure, or from the cumulative eflccis of MM V A: chronic exposure experienced over a long period of time, its observed with inorganic lead. When the rate ol lead intake exceeds excretion rates, lead poisoning occurs (t 'lu istensen. 197b). C hronic effects can be expressed by changing the biological organization of an organ, such as changes in cellular structure brought about bv asbestos and cotton dust. Toxic effects can also be conditioned reactions where initial exposure sensitizes the body for later, more intensive damage, for example, toluene diisocyanate (Christensen, 1976). I'UINIM AI I Items IOWAKDS OCCUPATIONAL III Al 111 t Vcupational health is basically preventive medicine which characteristically is concerned with the prevention EX P-1049 Page 4 of 16 PCB-ARCH-EXTQ378200 j Sirail'nil's coiiiiiiiii'iI i - of disease occurrence and with prevention of the con.se- ^ qucnces and the sequences of disease processes. Ij F.pidcmiological studies and biophysical and/or j biochemical studies have been designed to establish the | mcchanism(s) of biological interactions of environmental | agents and to define the thresholds at which such agents J interact with mammalian physiological systems. It is evi dent that occupational health policies should be J developed and formulated in light of these studies. It is well recognized that there may be no threshold for expo sure to some agents, such as ionizing radiation, whereby any level of exposure can interact with biological pro cesses to present a health hazard. The effects of toxicant exposure upon a living organism depends upon four basic factors: toxicity, concentration, duration of exposure and individual susceptibility. Individual susceptibility ean be influenced by age, nutritional status, preexisting health conditions and heredity. The primary goal of occupational health policies is to set standards whereby the risk(s) of detrimental conse quences to the worker's health as a result of exposure to xenobiotics are minimized. In formulating the policies of occupational health, issues pertaining to concepts of risks must be addressed. In this regard, there has been much debate over the role of the recognition of high risk groups in the formulation of occupational health policies and practices. The high risk group has been defined as a popu lation or set that differs from the general population or universal set because it is composed of individuals who show an unusual frequency of a specific disease process or individuals who are exposed to an unusually high concen tration of a suspected disease stimulus. Since the estab lishment of OSH A in 1970, and the concomitant Congres sional mandate, (the Clean Air Act) for the development of criteria for Federal occupational exposure standards to protect "all" workers, the recognition of the high risk population has had a decided impact upon the develop ment and implementation of standards which are intend ed to protect all workers. I.abor feels that prejob and periodic health examina tions throughout the individual's employment to identify the susceptible individual would be used against, rather than for the good of the individual. They claim that for economic reasons these persons would not he relocated within the company's work force, or that they could be eliminated from a particular job because of increased health risks from exposure to hazards which could result in increased compensation costs to the corporation. T he general consensus appears to be that unless there is a na tional policy of job security, or unless the union contract protects the hyfcrsusccptibles, the monitoring of the health status of the worker would be used by management to place or replace the worker. Risk or safety judgement In order to set health standards which arc effective, prudent and enforceable, it is important to differentiate clearly between risk assessment, which can be a quanti fiable, scientific, impartial or data-based determination, and the risk or safety judgment which is a normative, sub jective or political evaluation of how much risk or safety is acceptable to society, particularly to those facing the risks. The ultimate acceptability of the latter generally becomes a function of cost, relativity of the risks involv ed, and who will take the risk. What is needed is an in tegrative and rational approach whereby labor and management work together towards meeting a mutual goal--the protection of the safety and health of the worker. I'HK HOI K OF TOXICOI.OCICAL AND FlMDFMlOl.OCiTC'AI. DATA IN OCCUPATIONAL HKALTIT MANAGICMKNT' Classical toxicological LD50 studies, which permit nothing more than a preliminary classification of the poisonousness ol a substance, arc not valid for predicting the detrimental latent health effects of a toxicant, particu larly if death is the only effect examined. However, if more than just the endpoint of death is examined, this 4 EX P-1049 Page 5 of 16 PCB-ARCH-EXT0378201 type of acute toxicity study could and should yield much more valuable information regarding the interactions of potentially toxic substances with normal biological pro cesses. With careful clinical and laboratory observations prior to death, information regarding minimal symp tomatic and toxic dose, early symptoms of intoxication, target age involvement, duration of effect(s), and reversi bility of toxic insults to key physiologic processes could be obtained from these acute toxicity studies. which kills 50 percent of the treated animals. There is no consistent linear relationship between the effects of a given single lethal dose and the chronic administration of sublcthal doses which ultimate ly result in death since the physiologic processes which are impaired may be quite different in the two exposure pre sentations (Peck, 1968). Industrial accidents involving a single exposure to a high level of a toxic agent arc less likely to occur than the chronic intermittent exposure to low levels of toxicants. Truhart (1976) described the concept of "long-term tox icity'' resulting from the cumulative effects of absorption of small repeated doses of a toxicant. In identifying an oc cupational intoxicant it is important to determine how it might, and if it does indeed, interfere with the normal processes of a cell at "low" levels of exposure en countered during chronic intermittent exposure. Further more, the importance of routine physical examination of workers is indicated in order to monitor the health status of the individual, especially those with greater than two years' employment. These examinations should be made with an emphasis on detecting any predicted physiologic impairment that could be attributable to exposure to an occupational chemical(s) specific to a particular work en vironment. Although the best evidence of adverse human health ef fects of xenobiotics is probably a well conducted epidemi ological study, this should not be the only means of evalu ating the health effects of these agents. The design of laboratory testing of environmental/occupational agents on biological processes should be based upon the known chemical and physical properties of the compounds in question in order to elucidate and quantify injurious bio chemical and/or biophysical interactions. The key to understanding biochemical and/or biophysical inter actions resulting in injury to a living organism is the devel opment of investigative methods by which changes in cellular function and structure can be detected, and the application of these methods to elucidate the mechanism and/or factors which modulate chemical injury. Understanding the biological mechanisms for the interac tion of these compounds will enable us to recognize the potential of impairment and/or injury to human health. An example of a predictable interaction can be seen with polybrominated biphenyl (PBB). The halogenated biphenyls are relatively insoluble in water. Their high lipid volatility allows for sequestration in body fat, thereby greatly increasing their biologic half-life. A random survey of PBB levels in breast milk in Michigan revealed detectable body loading of PBB (Brilliant el at., 1978)'and suggested the biostability of these compounds. The struc tural similarity of the halogenated biphenyls with that of thyroxine suggested that PBB's could potentially com promise thyroid function. Thyroid ultrastructural changes in the rat have been reported following PBB feeding (Kasza, 1978). Results from a recent report (Allen-Rowlands el al., 1981) clearly indicate that PBB's do extend both immedi ate and residual effects on thyroid function m the rat from chronic low level exposure. The degree in the reduction of plasma thyroxine (T4) as a result of PBB ingestion was both dose and time dependent. Those animals given the lowest accumulative dose, 9 mg over 20 days, had a signi ficant depression of plasma T levels, compared to control animals, which persisted up to two months after cessation of PBB ingestion. PBB administration also resulted in a JULY/AUGUST '83 EX P-1049 Page 6 of 16 PCB-ARCH-EXT0378202 Strategics/continual significant reduction in the extrathyroidal incorporation of radioiodine into monoiodothyrosine, suggesting that PBB acts in some manner to inhibit the organification of iodine by peroxidase (Gilman and Marad, 1975). The ef fect of PBB on thyroid T secretion produced the expected negative feedback stimulation of pituitary TSH secretion, thereby indicating that chronic exposure to small doses of this xenobiotic resulted in the disruption of the normal hormonal cascade pituitary-thyroid axis. The persistence of this antithyroid action by PBB was indicated by the continued depressed T4 levels observed up to 5 months after cessation of PBB administration. These animal studies further demonstrated that even at the highest dose administered (6 mg/kg), where marked suppression in cir culating T4 occurred after only 10 days of treatment, there was no significant alteration in the body weight or the observed clinical appearance of the animal. In these same animals there was minimal alteration of behavior (Geller et al., 1979), and no observed effect on adrenal or testicular function (Castracane et al., 1982). These fin dings indicate the selective deleterious interaction of PBB with the pituitary-thyroid axis. The clinical relevance of these animal studies was indicated by the recent report of an increased incidence of hypothyroidism in a group of male workers exposed to PBB as evidence by increased pituitary TSH and decreased thyroid T4 levels (Bahn et al., 1980). The metabolic changes of toxicants such as PBB to more aqueous soluble and readily excretable molecules are minimized due to their lipophilic nature. Therefore, sequestration in adipose tissue greatly augments the bio logical half-life of these xenobiotics. Mobilization of these lipid soluble compounds could occur with conditions of stress and thereby potentiate or augment the latent health effects of these xenobiotics. Another potential target of impact in health is that of the offspring of exposed mothers who are generally much more sensitive to toxic effects of xenobiotics. The above evidence suggests that without specific biological testing directed to detect pre dictable detrimental long-term interactions of the xenobiotics with biological processes, impairment of health could go undetected. Furthermore, impairment of key homeostatic processes could contribute to the latent development of a disease process such as cancer. It is increasingly clear that for an effective occupational health care monitoring system to be developed, the avail able biochemical, biophysical and toxicological data management systems must be used, not only by re searchers, but also by corporate, labor and governmental participants involved in the formulation of occupational health care policies. The NIH-EPA Chemical Informa tion System contains spectroscopic, crystallographic, toxicological and regulatory data for more than 200,000 chemicals, with access by a local telephone call, on a fee for service basis (Milne et al., 1982). The CIS has proved to be especially useful for modeling environmentally significant properties of certain chemicals, e.g., pesti cides. The Oil and Hazardous Materials Technical Assis tance Data System (OHMTADS), managed by EPA, assists scientific personnel in identifying toxic spills, and the Chemical Hazard Response Information System (CHRIS) makes available reference guides for hazard assessment and spill response methods. The Chemical Transport Emergency Center (CHEMTREC) of the Manufacturing Chemists Association, acts as a clearing house for spill information and provides immediate ac tion response information for accidents (Cosmides, 1976b). The President's Science Advisory Committee, in their 1966 report on the handling of toxicological information (PSAC Report) defined toxicological information as "all information descriptive of the effects of chemicals on liv ing organisms or their component subsystems." Kissman (1980) emphasized that toxic substance control is clearly an area of growing public concern, and went on to discuss the variety of publications and services addressing toxico logical information, emphasizing on-line information retrieval systems. Participants at the Symposium on the Handling of Toxicological Information also considered the availability of technical information and assessed its validity and usefulness (Cosmides, 1976a). The Toxicology Information Program (TIP) of the Na tional Library of Medicine was established in 1967, and a Toxicological Information Response Center (TIRC) was added in 1971. These systems were designed to create data bases with information taken from the scientific literature and from the files of cooperating governmental, academic and industrial organizations; and to provide a variety of toxicological information services for the scientific com munity (Cosmides, 1976b). The TIRC is located at the Oak Ridge National Laboratory, and provides a query response capability, including evaluative multimedia monographs, and state of the art reviews (Huff, 1976). TOXL1NE, an on-line interactive bibliographic retrieval system based on the scientific literature, provides ref erences to published human and animal toxicity studies, and contains full bibliographic citations. CHEML1NE, an on-line service based on chemical abstracts, and CANCERLINE, based on carcinogenesis abstracts, are also included in TIP. The Toxicology Data Bank (TDB), designed to provide . an on-line integrative computer based retrieval system, is another component of TIP. Selection of chemical data for inclusion in the TDB is based on three major considera tions: (1) those toxic and potentially toxic chemicals most likely to reach a large segment of the population; (2) those agents shown to be carcinogenic, mutagenic or terato genic; and (3) those substances identified by other govern mental agencies as being important to their mission (Huff, 1976). Prior to acceptance into TDB, all records 6 DANGEROUS PROPERTIES OF INDUSTRIAL MATERIALS 1049 Page 7 of 16 PCB-ARCH-EXT0378203 undergo rigorous review by the National Institutes of isms, exposure potential, chronic and acute effects, and Health's Toxicology Study Section for scientific content epidemiologic and clinical studies of human exposure to and merit. toxic substances in the environment (Huff, 1976). The Other data sources include the chemical registry ser Environmental Mutagen Information Center (EMIC) and vices of the Chemical Abstracts Service (Tate, 1976), and Environmental Teratology Information Center (ETIC) the International Agency for Research on Cancer (IARC), are also located within the Oak Ridge National Labora a division of the World Health Organization. The IARC tory, and are charged with monitoring the literature and brings together experts on the carcinogenicity of various responding to information requests (Wassom, 1976). On chemicals to help determine and evaluate the open litera line services are also made available by Bibliographic ture relating to the carcinogenic hazard of chemicals to Retrieval Service (BRS), Lockheed Information Service, man. The IARC program represents information that has and the System Development Corporation (Kissman, been evaluated by experts in the field (Siegel, 1976). The 1980). IARC Carcinogenesis Bioassay Program was designed to Integrating the findings of biochemists, toxicologists develop exposure categories for chemicals in the world and epidemiologists into the management decision mak around us, and to make estimates as to how these chemi ing structure is not an easy task, but one which must be cals may be impacting man. The International Registry of addressed. The current litigative model for resolving cor Potentially Toxic Chemicals (IRPTC), part of the United porate responsibility and providing compensation for in I Nations Environmental Program, provides published jury, although effective in instituting social policy, is ex evaluations, data compilations and reviews of chemicals, pensive, time-consuming and cumbersome. On a large and guidelines for developing toxic substances legislation. scale, exclusive reliance on the litigative approach toward ! Another vital United Nations program, the International occupational health problems does not provide a sound i I Referral System (IRS), links users with information by basis for the development of an effective rationl health ii providing to interested parties a list of names and care policy. Furthermore, this method of conflict resolu I addresses of individuals with technical expertise about tion does not necessarily encourage preventive health care particular toxic substances (Cosmides, 1976b). attitudes or practices on the part of management or The Biomedical Sciences Section (BIOSCI) at the Oak Ridge National Laboratory provides reviews of the biologic effect of toxic compounds. employees. Clearly, we need a change in direction. An effective information system for incorporating various kinds of toxicological and epidemiological data into decision making about occupational health would confer several advantages. First, better worker health would prevent the unnecessary loss of productivity due to illness, absenteeism or lowered output due to health prob lems. Second, fewer work related illnesses would reduce disability and compensation disbursements, as well as direct medical payments and indirect insurance costs. Third, an occupational health system which incorporates baseline health observations and routine monitoring of specific biologic systems suspect of being impaired by ex posure to occupational toxicants could well act as a nega tive feedback system to preclude serious health problems, and to inculcate in the worker positive attitudes about the value of preventive health care. Feedback information derived from health monitoring of workers would prob ably reduce the risk of adverse health effects, and in doing so, provide a better self image for the worker who then feels some modicum of personal control over workplace risks. This idea of co-responsibility of the worker and man agement obviously presupposes changes'in the structure of contracts, the negotiation process, the parameters of management responsibilities and the patterns of informa tion exchange. It also offers a perspective for evaluation and selection of a suitable approach toward the concept of "acceptable risk." The idea of co-responsibility repre sents an attempt to consider benefits and risks related to the same person. Part 2 in next issue. EX P-1049 Page 8 of 16 PCB-ARCH-EXT0378204 Polychlorinated Biphenyls STORAGE AND HANDLING INFORMATION: TRANSPORT, RAIL (%): 40.3 POLYCHLORINATED BIPHENYLS TRANSPORT, BARGE (Vo): 47.8 . TRANSPORT, TRUCK (Vo): 11.9 CAS RN: 1336-36-3 NIOSH H: TQ1350000 CONTAINERS: Former shipment containers include glass bottles (5L), earthenware (5L), plastic bottles (5L), and metal cans and drums (30 L and 250 L respectively) (85EZAO IMDG.77/1MCO) (49CFR 101.1) (RARAD5 SYNS: PCB; polychlorinated diphenyls; askarels; aro- 80/1ATA) clor; aroclor 1221; aroclor 1232; aroclor 1242; aroclor GENERAL STORAGE PROCEDURE: Store PCBs in 1248; aroclor 1254; aroclor 1260; aroclor 1262; aroclor isolated areas where the drums are not vulnerable to 1268; aroclor 2565; aroclor 4465; chlophen; chlorextol; damage from vehicles, forklifts, or other moving equip chlorinated biphenyl; chlorinated diphenyl; chlorinated ment. i diphenylene; chloro biphenyl; chloro-1,1 -biphenyl; chlor- GENERAL HANDLING PROCEDURE: Slight fire t odiphenyl (42% chlorine); chlorodiphenyl (54% hazards. Strong acute irritants via inhalation. Absorbed I i chlorine); dykanol; fenclor; inerteen; kanechlor; kanechlor 300; kanechlor 400; kanechlor 500; montar; no- through skin and mucous membranes and eyes. (DPIMR 1(3)38,81/SAX) !i flamol; phenochlor; phenoclor; polychlorinated bi PRODUCTION SITES: Monsanto, Anniston, AL; J ! phenyls; polychlorinated diphenyls; polychlorobiphenyl; pyralene; pyranol; PCB's; santotherm; santotherm FR; Sauget (E. St. Louis), IL; Not produced after 1977. Mon santo largest former producer. j sovol; therminol FR-1; 1,1 '-biphenyl, chlorinated; HYDROLYSIS, PRODUCT OF: Not hydrolyzed under i |,1 '-biphenyl, chloro derivs. normal reaction conditions. CHEMICAL FORMULA: (C,H,-x2)C1x BINARY REACTANTS: PCBs are generally inert when SPECIES IN MIXTURE: Technical polychlorinated placed in contact with other materials under normal con biphenyls are mixtures of chlorinated biphenyls contain ditions of temperature and pressure. However, strong ing many kinds of isomers and species. Typical PCB mix sunlight conditions may cause the formation of phenolic tures may contain 3,4,5,6, and 7 chlorine atoms per materials and traces of polychlorinated dibenzofurans. biphenyl molecule in varying proportions. Technical mix (EVHPAZ 1,15,72/HUT) (BECTA6 10(6)372,73/CRO) tures may vary from mobile oily liquids to white SYNERGISTIC MATERIALS: Carbon tetrachloride crystalline solids and non-crystalline resins. Technical DETECTION LIMIT (Lab; Techniques, Ref) (ppm): mixtures may contain traces of polychlorinated diben- .001; gas layer chromatography; (E234) zofurans which are considered more toxic than PCBs. STANDARD CODES: Superfund designated (hazardous (DPIMR 1(3)38,81/SAX) substances) list; UN No. 2315; IMCO-UN class 9 COMMON USES: Coolants in transformers, fluorescent miscellaneous dangerous substances, no label required, ballasts, electrical insulation plasticizer, epoxy paints, stow on deck or under deck for passenger and cargo ships, carbonless reproduction paper, lubricants; much of the stow in a recoverable position separated from all total production of PCBs still in use as dielectric (in foodstuffs. Packaging group II. (85EZAO sulator), heat transfer or hydraulic fluids. (DPIMR IMDG.77/IMCO) NO I ATA; CFR-class ORM-E, no 1(3)38,81/SAX) label required, CFR packaging requirement 173.510, no STRUCTURAL FORMULA: limit on package size. (45FR34560, 5-22-80) FLAMMABILITY: Nonflammable Cl Cl Cl Cl mf:C12CI10 mw: 498.58 TOXIC COMBUSTION PROD.: Emits highly toxic vapors when heated to decomposition. FLA SH POINT (C.): 200 0 . A UTO IGNITION POINT (C.): 240 c c c* c cee Cl EXPLOSIVENESS: Stable BOILING POINT (C.): 340; 340 to 375 BOILING CHARACTERISTICS: DPIMR 1(3)38,81/SAX * SPECIFIC GRAVITY: 1.182 to 1.44 (DPIMR * c* c Cl Cl c* c Cl Cl 1(3)38,81/SAX) . PERSISTENCY: High; highly chlorinated forms of PCBs containing 5 or more chlorine atoms per biphenyl molecule are much more persistent in the environment . than PCBs containing 1,2, or 3 chlorine atoms. Tetrachlorobiphcnyls are considered intermediate in per- JULY/AUGUST '83 EX P-1049 Page 9 of 16 PCB-ARCH-EXT0378205 Polychlorinated Biphenyls sistencc. (AWQC** PB81-117798,80/ECAO) En- chloracne, hyperpigmentation of skin, small head cir ij vironmentally, approximately one chlorine atom of each cumference and other teratogenic effects. In chickens, |i chlorinated biphenyl is lost per year. (39KOAS dogs, swine, mice, teratogenic effects include cleft ;j 56,78/BUN) Microbial aerobic degradation studies using palates, extra phalanges, shortened long bones, and other !j mixed cultures in water indicated. effects. (IMEMDT 18,78/IARC) In Japan, several |i TOXICITY: teratogenic effects in offspring of patients suffering from yusho (oil) disease were noted, including skull deforma j POTENTIAL FOR ACCUMULATION: High in liver tions, increased melanin pigmen, small size for age, and |i and fatty tissues. Eagle 14,000 ppm. Shrimp at 10 ppb for stillborn infants. (PDTNBH 6(1)20,77/YAM) i: 48 hour had 1300 ppb. Perequin falcon 2000 ppm, oysters CHRONIC A QUA TIC TOXICITY LIMIT (Reference): I1 at 10 ppb for 96 hour had 33,000 ppb. Freshwater residue PCB criterion to protect freshwater aquatic life is .014 ij data show that PCBs accumulate to relatively high levels .micro.g/1 (parts per billion) as a 24-H average. I in invertebrate tissues and that for most species PCBs are not rapidly depleted when exposure is discontinued. (AWQC** PB81-117798,80/ECAO) ACUTE WATERFOWL TOXICITY: 2000 ppm mg/kg |) Bioconcentration factors for invertebrate speciesrange LD50, mallards (D31) j! from 2700 to 108.000. Bioconcentration factors for PCB CHRONIC WATERFOWL TOXICITY LIMIT: Causes il exposures of fish species range from 3000 to 274,000. thin eggs (E91) :1 (ECAO** PB81-117798,80/ECAD) MAJOR SPECIES THREA TENED: Bird (egg produc | FOOD CHAIN CONTAMINATION POTENTIAL: tion) aquatic life and predators. j Displays same accumulative characteristics as DDT and INHALATION LIMIT (Text): Threshold limit values l other chlorinated pesticides. Bioaccumulation and/or --skin.exposure. Time-weighted averages at 42 and 54% j! biomagnification of PCBs in the Lake Ontario ecosystem chlorine respectively; short term exposure limits at 42 and | has been shown to occur via water, sediments, plankton, 54% chlorine respectively. Skin exposure notation refers catfish, herring gull and eggs, and humans and human to the potential contribution to the overall exposure by the milk. (TEHEDH 4,81,80/SAF) cutaneous route including mucous membranes and eye, A ETIOLOGICAL POTENTIAL: Renders mallards more either airborne, or direct contact with PCB itself. ) susceptible to duck hepatitis. PCBs in combination with (ACG1H* TLV 80/ACGIH) , rubella virus cause an increase in cleft palate formation in GENERAL SENSATION: Strong irritant. Can be ab ; offspring of pregnant mice (Teratogenic effect). sorbed through the skin. Causes liver damage and skin (HKEGDK 7(1)21,80/WAT) changes. The higher the chlorine content, the more toxic. l CARCINOGENICITY: Kanechlor 500 added to the dirt Oxides are more toxic yet. Skin lesions characterized by \ for 32 weeks at doses of 100 to 500 mg/kg resulted in small pimples and dark pigmentation. Later comedones ' hepatocellular carcinoma (liver cancer) in 5 of 12 male and pustules develop. Systemic poisoning symptoms in mice. (JNCIAM 51,1637,73/ITO) Chronic administra- clude nausea, vomiting, loss of weight, jaundice, edema, ; tion of aroclor 1260 to female rats at an average dose of 5 and abdominal pain. Can be absorbed through skin. \ mg/kg/day for 21 months resulted in a 14% incidence of Strong irritant. ! liver cancer and a 78% incidence of neoplastic nodules, DIRECT HUMAN INGESTION (mg/KGwt.): 500; 10 j (JNCIAM 55,1453,75/KIM) in 1979 PCBs were classified mg/mJ; lowest toxic dose reported, LDLO, for humans > as '`probably carcinogenic for humans" by a working by oral route is 500 mg/kg body weight for PCBs as a ! group of the International Agency for Research on general class of compounds. Lowest toxic concentration, : Cancer (IARC), an agency of the World Health Organiza- TCLO, for humans by inhalation route is 10 mg/m5 for : tion (WHO). (IMEMDT 1-20,1,79/1 ARC) Two aroclor 1242. (RTECS* 77/RTECS) retrospective mortality studies of a cohort of workers oc- RECOMMENDED DRINKING WATER LIMITS (Ref ; cupationally exposed to these chemicals have been con erence): Due to the potential carcinogenic effect, the con ducted. In the U.S., two malignant tumors and four other centration of PCBs should be zero based on the non cancers were diagnosed in 31 workers (or 19%) heavily ex threshold assumption. Since this level may not be at posed to aroclor 1254. In Japan, 9 of 22 deaths (or 41%) tainable, levels which raise the human lifetime cancer risk were due to malignant neoplasms (tumors in stomach, IE-5, lE-6and IE-7 are allowed. These levels are .79 ppt, . liver, lungs, and breast) after prolonged exposure to .079 ppt, and .0079 ppt, respectively.'(AWQC** PB81- PCBs. (IMEMDT 18,78/IARC) 117798,80/ECAO) MUTAGENICITY: Aroclor 1221 causes mutagenic ef PERSONAL SAFETY PRECAUTIONS: Wear personal fects in salmonella typhimurium. Other aroclors in protective clothing and use self-contained breathing cluding 1242, 1254, 1268 do not cause mutagenic effects. apparatus. ; (RCOCB8 15,653,76/WYN) (IMEMDT 18,78/IARC) ACUTE HAZARD LEVEL: Spill area should be con * TERATOGENICITY: Aroclor 1248, when fed to female sidered as a source of strong inhalation irritant which is rhesus monkeys, produced offspring suffering from highly toxic when inhaled or absorbed by the skin. Protect % v DANGEROUS PROPERTIES OF INDUSTRIAL MATERI/EXRP-1049 Page 10 of 16 PCB-ARCH-EXT0378206 Polychlorinated Biphenyls TOXICITY FRESH WATER TOXICITY TEXT: Cone. 1.17-60 .278 Expos (Hr) 96 96 Specie Trout Bluegill Effect TLM TLM Test Environment Reference E91 E91 SALT WATER TOXICITY TEXT: Cone. .03 Expos (Hr) 24 Specie Saltwater Aquatic Life Effect Acute Toxicity Test Environment Reference AWQC** PB81-117798, 80/EC AD ANIMAL TOXICITY TEXT: Value 500-1000 2000-4000 170 2000-3000 1000-3000 600-3000 2000-5000 Time Species Rats Rats G. Pigs Mallard Pheasant Bobwhite Coturnix Param. Route Est. Refs. (1254) (D31) (1268) (D31) E187 El 87 El 87 El 87 E187 fish and wildlife by containment procedures. Protect potable water supplies by containment procedures. CHRONIC HAZARD LEVEL: Strong chronic irritant. Toxic. Skin absorption potential. Liver and skn disorders in humans. Reproduction abnormalities in humans and mammals. In birds causes thin egg shells. DEGREE OF HAZARD TO PUBLIC HEALTH: While acute toxicity is reported low, typical contaminants of PCB are some of the most toxic materials known to man. Considered strong irritant. Highly toxic when inhaled or ingested. Chronically toxic with inhalation or skin ab- sorption. Rapidly accumulated in food chain. Some of the . hazards of the PCB's can be attributed to polychlorodi- benzofuran contaminants (E190). ' ENVIRONMENTAL IMPACT DUE TO A SPILL OR MASSIVE RELEASE: AIR POLLUTION: Toxic. Volatiliz.es slowly from bodies ; of water. . ACTION LEVELS: Notify air authority. Restrict access A . to affected waters or land spill areas. Evacuate area if near homes. IN SITU AMELIORATION: Seek environmental engineering assistance through EPA's Environmental Response Team (ERT), Edison, NJ, 24-hour no. t 201-321-6660. Single-stage contactor dose of powdered t carbon required to reduce the initial concentration (C.l.) I k V IU1.Y/AUGUST '83 i of PCB-1232; PCB-1221 at 1.0 mg/L to a final concentra tion (C.F.) of .001 mg/L at neutral pH is 240;520 mg/L for C.l. .01 mg/L to C.F. .001 mg/L, use 2.2 5.7 mg car bon per liter. Granular carbon column doses for con tinuous operation until breakthrough (where effluent concentration equals influent concentration) are 1.6; 4.1 mg/L to treat a C.l. of 1.0 mg/1 or a dose of .5; 1.1 mg/L to treat a C.l. of .01 mg/L. Multiplying the carbon dose given by 8000 will convert it to the number of pounds re quired per one million gallons of water. (CAITO* 80/DOB) Pump or vacuum undissolved portion from stream or pond bottom. Use carbon or peat on con taminated water. Absorb spilled portions on land with carbon or peat. Remove contaminated soil. BEA CH/SHORE RESTORA TION: Absorb spilled por tions with carbon or peat. Do not burn. Remove con taminated soil. AVAL. OF COUNTERMEASURE MATERIAL: Pumps--fire department; vacuum--swimming pool sup pliers; carbon--water ticatment plants, sugar refineries; peat--nurseries, floral shops. DISPOSAL METHOD: Capacitors (small and large); properly drained transformers; contaminated soil, dirt, rags, and other debris, dredge spoils; municipal sludges; and properly drained containers (drums) may be sent to EPA approved chemical waste landfill sites for burial. Liquid PCB waste must be stored and sent to incineration EX P-1049 Page 11 of 16 PCB-ARCH-EXT0378207 !! Polychlorinated Biphenyls facilities approved by EPA. Possible use of PCBX mobile unit from Sunohio for treatment of transformer oil con taining not more than 1000 ppm arolcor. (PCBX** 81/SAX) DISPOSAL NOTIFICA TION: Contact EPA regional of fices for location of EPA approved chemical waste land fills and incineration facilities. INDUSTRIAL FOULING POT.: Not acceptable in food processing waters. MAJOR WATER USE THREATENED: Fisheries, potable supply, recreation. PROBABLE LOCATION AND STATE OF MATER IAL: Liquid, waxy solids, or resins. Will sink to bottom of streams or ponds and dissolve slowly. SOIL CHEMISTR Y: All absorb strongly on soils COLOR IN WATER: Colorless PCB DATA REFERENCES: TUMORIGEN CARCINOGENIC DETERM (NATION: HUM AN SUSPECTED TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW OCCUPATIONAL EXPOSURE TO POLY CHLORINATED BIPHENYLS reem std-air: TWA 1.0 ug/m' "NIOSH MANUAL OF ANALYTICAL METHODS" VOL 1 244,253, VOL 2 S121, VOL 4 s!20* NIMAM NIOSH CURRENT INTELLIGENCE BULLETIN 7, 1975 REPORTED IN EPA TSCA INVENTORY, 1980 EPA TSCA 8E NO.07780209-FOLLOWUP REPLY RECEIVED AS OF APRIL, 1980 CODEN: IARC** 18,43,78 EVHPAZ 1,105,72 JOCMA7 18,109,76 FEPRA7 34,1675.75 ARVPAX 14,139,74 ARPAAQ 94,125,72 CHRYAQ 49(4),14,76 STEVA8 2(4),305,74 BISNAS 20.958,70 27ZTAP 3,34,69 NT1S** PCB (AROCLOR 1260) MUTAGEN DATA: CYT-RAT: ORL 1080 mg/kg/26W-C TERATOGENIC DATA: ORL-RATTDLO: 1675 ORL-MUSTDLO: 74 SCU-MUSTDLO: 143 mg/kg (MGN) mg/kg (62D pre/1- 10D pr< mg/kg (2 ID post) TUMOR1GENIC DATA: ORL-RATTDLO: 4380 mg/kg/83W-C TFX:CAR TOXICITY DATA: ORL-RAT LD50: SKN-RBT LDLO: 1350 mg/kg 2000 mg/kg DATA REFERENCES: TUMORIGEN MUTAGEN TERATOGEN CARCINOGENIC DETERMINATION: HUMAN SUSPECTED TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW TOXICOLOGY REVIEW OCCUPATIONAL EXPOSURE TO POLY CHLORINATED BIPHENYLS: RECM STD-AIR: TWA 1.0 ug/m3 CODEN: APTOD9 19,A 16,80 CODEN: FCTXAV 12,63,74 ENVRAL 6,176,73 ENPBBC 5,54,75 CODEN: JNC1AM 55,1453,75 CODEN: FCTXAV 12,63,74 ARVPAX 14,139,74 CODEN IARC** 18,43,78 EVHPAZ 1,105,72 . ARVPAX 14,139,74 STEVA8 2(4),305,74 BISNAS 20,958,70 NT1S 98 DANGEHOUS PROPERTIES OF INDUSTRIAL MATERI^FpP1049 Page 12 of 16 PCB-ARCH-EXT0378208 PCB (AROCLOR 1254) TERATOGENIC DATA: ORL-RAT TDLO: 188 ORL-RAT TDLO: 645 ORL-RAT TDLO: 90 ORL-RBTTDLO: 350 mg/kg (MGN) mg/kg (MGN) mg/kg (7-15D preg) mg/kg (1-28D preg) TUMORIGENIC DATA: ORL-RAT TDLO: ORL-MUS TDLO: SKN-MUSTDLO: 4 gm/kg/2Y-I TFX:ETA 17 gm/kg/48W-C TFX:NEO 4 mg/kg TFX:ETA TOXICITY DATA: ORL-RAT LD50: IVN-RAT LD50: . IPR-MUS LD50: v 1295 358 2840 mg/kg mg/kg mg/kg Polychlorinated Biphenyls NCI CARCINOGENESIS BIOASSAY COMPLETED: RESULTS INDEFINITE: RAT "NIOSH MANUAL OF ANALYTICAL METHODS" VOL2S121 NIMAM* CODEN: IARC** 18,43,78 DTLVS* 4,89,80 EVHPAZ 1,105,72 ARVPAX 14,139,74 RREVAH 44,1,73 STEVA8 2(4), 305,74 BISNAS 20,958,70 FEREAC 39,23540,74 NTIS** NCITR* NCI-CG-TR-38,78 PCB (AROCLOR 1248) CODEN: TERATOGENIC DATA: FCTXAV 12,63,74 ORL-MKY TDLO: 455 mg/kg (26W pre) FCTXAV 12,63,74 ORL-RBTTDLO: 165 mg/kg (1 -31D preg) FCTXAV 11,471,73 EVPHB1 1,67,71 TOXICITY DATA: ORL-RAT LD50: 11 gm/kg CODEN SKN-RBT LDLO: 1269 mg/kg NCITR* NCI-CG-TR-38,78 DATA REFERENCES: JNCIAM 53,547,74 ' TUMORIGEN BECTA6 18,552,77 TERATOGEN CODEN: FCTXAV 12,63,74 FCTXAV 12,63,74 BECTA6 8,245,72 ii i DATA REFERENCES: TUMORIGEN TERATOGEN CARCINOGENIC DETERMINATION: HUMAN SUSPECTED TLV-TWA 500 ug/m3: STEL 1 mg/m3 (skin) CARCINOGENIC DETERMINATION: HUMAN SUSPECTED TOXICOLOGY REVIEW TOXICOLOGY REVIEW OCCUPATIONAL EXPOSURE TO POLYCHLORI NATED BIPHENYLS: RECM STD-AIR: TWA 1.0 ug/m3 NCI CARCINOGENESIS BIOASSAY COM PLETED: RESULTS INDEFINITE: RAT "NIOSH MANUAL OF ANALYTICAL METHODS" VOL 2S121 NIMAM'T LD TOXICOLOGY REVIEW i TOXICOLOGY REVIEW i TOXICOLOGY REVIEW CODEN 1ARC** 18,43,78 ! TOXICOLOGY REVIEW DTLVS* 4,89,80 TOXICOLOGY REVIEW EVHPAZ 1,105,72 TOXICOLOGY REVIEW ARVPAX 14,139,72 TOXICOLOGY REVIEW RREVAH 44,1,73 TOXICOLOGY REVIEW - STEVA8 2(4),305,74 OSHA STANDARD--air: TWA 500 ug/m3 (skin) B1SNAS 20,958,70 (SCP-I) FEREAC 39,23540,74 OCCUPATIONAL EXPOSURE TO POLYCHLORI NT1S** NATED BIPHENYLS RECM STD-air: TWA 1.0 NCITR* j i ug/m3 NCI-CG-TR-38,78 i IULY/AUGUST'83 l EX P-1049 Page 13 of 16 PCB-ARCH-EXT0378209 Polychlorinated Diphenyls PCB (AROCLOR 1242) sure, possible adverse health effects, research project ini TERATOGENIC DATA: tiation. (47FR21302) ORL-RAT TDLO: 945 mg/kg (36W pre) l ORL-RATTDLO: 1890 mg/kg (36W pre) CITATION NUMBER = 47.223.58 i ! Ii TOXICITY DATA: (47FR52066ff, 11-18-82) t 1HL-HMNTCL.O: 10 mg/m3 TFXrIRR PROPOSED RULE: Revision of 40cFR430.174, i ORL-RAT LD50: 4250 mg/kg SCU-GPG LDLO: 345 mg/kg i 430.175, Environmental Protection Agency, Clean Water Act; Proposed effluent limitation guideline, pulp, paper, & paperboard point source category, New Stationary DATA REFERENCES: Source Performance Standard; Comments solicited by TUMORIGEN TERATOGEN 1-17-83. (46FR1430) CARCINOGENIC DETERMINATION: HUMAN I SUSPECTED TLV-TWA 1 mg/m3; STEL 2 mg/m3 (skin) TOXICOLOGY REVIEW t TOXICOLOGY REVIEW TOXICOLOGY REVIEW CITATION NUMBER = 47.233.6 (47FR54436, 12-3-82) FINAL RULE: Revision of 40FR761.3, Environmental Protection Agency, Office of Toxic Substances, Toxic '! TOXICOLOGY REVIEW TOXICOLOGY REVIEW Substances Control Act; Manufacturing, processing, dis tribution in commerce, use prohibitions; Use in electrical OSHA STANDARD-air: TWA 1 mg/m3 (skin) (SCP-1) equipment. (47FR37342) OCCUPATIONAL EXPOSURE TO POLYCHLORI NATED BIPHENYLS: RECM STD-AIR: TWA 1.0 ug/m3 - NTiS** "NIOSH MANUAL OF ANALYTICAL METHODS" VOL4S120 ADDITIONAL REFERENCES CIS Sources of Information CODEN: AECTCV 3,479,75/76 AECTCV 3,479,75/6 CIS, El Mass Spectrometry StOSH/CIS RTECS: TQ1360000 EPA /CIS, WaterDROP CIS, Cambridge X-Ray Crystallography: 2051-24-3.01 CODEN: CIS. Cl Mass Spectrometry EPA/CIS. OHM/TADS: 7216860 85CYHB 2,153,59 TXAPA9 24,434,73 PHRPA6 59,1085,44 Non-CIS References EPA. Pesticides--Analytical Ref. Stnds.: 5700E.5705 CODEN: I ARC** 18,43,78 DTLVS* 4,88,80 EVHPAZ 1,105,72 ARVPAX 14,139,74 RREVAH 44,1,73 STEVA8 2(4),305,74 BISNAS 20,958,70 FEREAC 39,23540,74 NTIS** EPA, STORET: 39512,39504,39505,39506,39507 EPA. Pesticides--Registered Inert Ingredients FDA/EPA. Pesticides Ref. Standards: 370 EPA. Effluent Guidelines Priority Pollutants ORNL. EM/C ORNL. ETIC . USI'H'S, Fish Control l.ab Data Rase IARC, Rulletin on Chemicals Testedfor Carcin. EPA, TSCA Inventory List IARC, Monographs {Carcinogenicity Reviews) EPA, Expanded Potential Industrial Car. <t Mut. NI.M. Vox Tips: 9:23.9:27,8:19.35:41.18:37 NLM. CHEMUNE: TOXUNE. TOXHACK USAE, Defense Pest Mgt. Information Analysis Cntr. OSHA. Air Contaminants RECENT FEDERAL REGISTER CITATIONS (Polychlorinated Biphenyls)) NEPA *49!M, Manual of Hazardous Chemical Reactions: 49IM-338 EPA. Potential Carcinogen Study, Selected Chem. Aldrich Catalog/Handbook: 163279 USCG. CHRIS (Chemical Hazards Response Info System: PCB CITATION NUMBER = 47.211.2 (47FR49471, 11-1-82) EPA/IERL. Non-Criteria Pollutant Emissions EPA/NCTR. Industrial Carcinogen and Mutagen Study EPA. Environmental Carcinogen Assessment Program EPA, Quality Criteria for Water EPA, Chemical Indicators, Industrial Contamination 1 NOTICE: National Institute of Occupational Safety & Michigan Critical Materials Register 1 Health, Centers for Disease Control; Occupational expo- DHEW/NIH, Laboratory Chemicals Monographs f 100 EX P-1049 DANGEROUS PROPERTIES OF INDUSTRIAL MATp^ge 140F 16 PCB-ARCH-EXT0378210 or the environment, taking into account the economic, so cial and environmental costs and benefits of the use of any pesticide'. Whenever the Agency becomes aware of the potential for unreasonable effects, a pesticide may be sub jected to an extensive scientific review and risk-benefit analysis. Such a review was instigated for paraquat in 1978. Sever al potential adverse effects (or risk criteria) were identified: teratogenicity, lack of emergency treatment, chronic ef fects, reproductive effects. In response to the identification of these possible effects, the Agency undertook a compre hensive initial data screen involving approximately 5,000 papers, the majority of which were deemed inadequate for Agency evaluation. The Agency then concentrated its re view upon selected papers germane to the evaluation of the risk criteria at issue. With regard to the lack of emergency treatment, the Agency evaluated all paraquat poisoning incidents. It was found that nearly all fatal cases involved ingestion either as a result of suicide attempts or drinking from unlabelled storage containers. In either instance, little may be accom plished through more stringent regulation. The paraquat products implicated in poisonous incidents already bear re stricted use classification. Current label precautions inform the user that the pesticide is not to be mixed or stored in any container other than the original. In addition to present precautionary labelling, the Agency believes that the Cavalli and Fletcher treatment regime offers a therapy demon strated to be partially effective. The Agency has, therefore, adopted the position that the existing labelling, coupled with the Cavalli and Fletcher treatment regime, adequately address the issue of emergency treatment for exposure. Available data does not allow for an assessment of the adequacy of emergency treatment for dermal absorption. Howwever, relatively few dermal exposure cases have re sulted in fatalities. Incident data, principally thos obtained through the pesticide incident monitoring system (PIMS), have indicated an extremely limited number of dermal toxi city cases. The majority of these cases did not result in fa talities, but were related to dermal irritation, loss of finger nails and other subacute dermal effects. Again, paraquat products, with the exception of a homeowner use product containing a very low concentration of the active ingredi ent, bear restricted use classification. Applicators of such products are required to undergo training in the safe hand ling and use of pesticides and receive instruction in product labelling and label interpretation. Current paraquat prod ucts bear labelling instructions for mixers and applicators in exposure reduction techniques. In relation to chronic effects, review of the available data indicated inadeqacies in the studies for nearly every chronic effect criterion. Insufficient or invalid data are available for oncogenicity, mutagenicity, and reproductive effects. The Agency has made no conclusion concerning these effects. The Agency will impose data requirements aimed at clarify ing any potential risks related to these risk criteria. In the NOVEMBER/DECEMBER '83 case of teratogenicity, two adequate studies have been re viewed. The Agency has concluded that paraquat does not exhibit any teratogenic effect. The available information does not indicate conclusively the existence of adverse unreasonable effects. Therefore, no immediate regulatory action need be taken. Additional data will, however, be required of paraquat registrations, although the majority of the required testing has been either recently concluded or is in progress. The Agency anticipates the data to begin arriving within the next few months. Pending the receipt and evaluation of these data, paraquat has been returned to normal registration processing. Source: United States Department of State, Washington, D.C., USA (February 1983). POLYCHLORINATED BIPHENYLS (PCBs) he Environmental Protection Agency (EPA) of the TUnited States of America issued a final fule on 21 October 1982 amending the 31 May 1979 PCB rule which generally prohibits the manufacture, processing, distribu tion in commerce and use of PCBs (Bulletin, Vol. 3 No. 1 and Vol. 4 No. 2). The rule-making exludes from the ban processes that manufacture PCBs as by-products and impurities as long as the PCBs released from the processes into the air, water, or products do not exceed the limits stated in this rule. In the final rule: (i) EPA is setting numerical cutoffs for purposes of defining the absence of PCBs in releases from closed and controlled waste processes; (ii) EPA is adding additional disposal mechanisms to the list of acceptable mechanisms for the disposal of controlled wastes con taining PCBs in concentrations between the limit of quan titation and 50 ppm; and (iii) EPA is instituting a new record-keeping requirement in addition to the record keeping requirements listed in the proposed rule. In this final rule, EPA is excluding from the require ments of section 6 (e) the manufacture, processing, distri bution in commerce, and use of PCBs created in closed manufacturing processes and controlled waste manufactur ing processes. A closed manufacturing process is defined as a manufacturing process that produces PCBs, but releases PCBs only in concentrations below the practical limits of quantitation for PCBs in air emissions, water effluents, products, and process wastes. Similarly, a controlled waste manufacturing process is a manufacturing process that produces PCBs, but releases PCBs only in concentrations below the practical limits of quantitation for PCBs in air emissions, water effluents, and products, and all remaining PCBs are disposed of in accordance with methods for disposal specified in this rule. Controlled wastes containing PCBs in concentrations bettween the practical limit of quantitation and 50 ppm, must EX P-1049 Pag# 15 of 16 PCB-ARCH-EXT0378211 f Update / Continued be disposed of in a qualified incinerator or in an EPAapproved PCB landfill, or be stored for incineration or landfilling. For the purposes of this rule, the practical limit of quan titation for PCBs in any release to air is 10 micrograms per cubic meter (roughly 0.01 ppm) per resolvable gas chroma tographic peak; in any release to water the limit is 100 micrograms per liter (roughly 0.1 ppm) per resolvable gas chromatographic peak; and in any product or waste, the limit is 2 micrograms per gram (2 ppm) per resolvalbe gas chromatographic peak. These PCB concentrations repre sent the lowest concentrations of PCBs which EPA believes can be pracitally quantified in air, water, products, and process waste streams. EPA believes that, for all practical purposes, it would be impossible to determine whether reg ulation of PCBs below these levels had any effect on actu ally reducing releases of PCBs. Consequently, EPA has concluded that there would be no measurable gain in pro tecting the environment or public health by attemtping to regulate PCBs at levels that are not practically measurable. In specifying the methods for the disposal of controlled wastes containing less than 50 ppm PCBs, EPA is confident that these wastes will be disposed of in a manner that will result in little or no environmental contamination. At the same time, EPA believes that this rule will not place unrea sonable burdens on existing disposal facilities or create ex cessive disposal costs for manufacturers disposing of wastes containing PCBs in concentrations between the practical limit of quantitation and 50 ppm. In addition to meeting the criteria for eligibility described above, manufacturers who want to take advantage of the exclusion must fulfil certain record-keeping and reporting requirements. These include: (i) certifying that their pro cesses qualify; (ii) notifying EPA that they have made this certification and how they have made the determination; and (iii) maintaining a record of the determination that their processes qualify for exclusion. Manufacturers are provided the option of conducting theoretical assessments to support certification or of conducting actual monitoring 'I of PCB levels in releases. Recertification and renotification to EPA are required upon significant process changes. In providing for theoretical assessments in lieu of actual monitoring of PCB levels, EPA has concluded that such ; determinations may be possible in certain process situa- : tions; therefore, it would br unreasonalbe to require actual ; monitoring of PCB levels in all situations. Manufacturers have the burden of making the decision on when a theoreti- ' cal assessment in lieu of actual monitoring of PCB levels is appropriate. Because of the difficulty of estimating actual PCB levels, EPA recommends that a theoretical assessment ' be used to qualify for the exclusion only when the results of the theoretical assessment indicate that PCB concentra tions in releases will be substantially below the practical 3 limits of quantitation. EPA is issuing some general guidelines for conducting a theoretical assessment in order to aid manufacturers in completing this assessment. Nonetheless, EPA expects that each individual manufacturer will exercise judgment in | choosing the methodology to be used in conducting a theo- | retical assessment, and in deciding when to undertake j chemical analysis of process streams to determine if a process qualifies for exclusion. EPA believes that record- ; keeping and reporting are necessary to ensure that only | processes which meet the definitions of closed and con- 1 trolled waste processes are permitted to operate under this % exclusion. A reporting requirement also enables EPA tode- ; velop an effective compliance monitoring program. * Source: United Slates Federal Register No. 47 of 21 October 1982. ? k EX P-1049 20 DANGEROUS PROPERTIES OF INDUSTRIAL MATFRipia0el6 Of 16 PCB-ARCH-EXT0378212