Document MojoRx7XdYeq8wMog6o2vEZa

/* MEMORANDUM .-.TO : Officc/Division Directors Oni'AlVIMUNT Ol: Ill-ALTII. UnWCATiON, AND WIJL!-. ' iutu ft: m mvici-: . i; i us*. iihi'AM' o*n uuf. NATIONAL ;mn M NUTTY AND Ui:.\1.T It ' I1VIC: October 29 > 1976 - FUOM : .Chief, Technical Kvaltwition and Review Rranclv Office of Intramural Coordination and Special 1'rajeccs. ~ XUflIPCT: Vinyl Chloride - Induction by Inhalation of Mammary Tutors in Laboratory Rats In a letter dated October 11, 1976, the National Institute Cor Occupational Safety end Health (HIOSU) was informed by B. F. Goodrich Comp-ny of: a recent unpublished report on the carcinogenicity of vinyl chlorido. In this report. Dr- Ccsarc Maltoni presented che results of 52-vueh inhalation studies in rats using concentrations of 50, 25, 10, 5, and 3 ppm vinyl chloride. The results of the 50 ppm trial involving 300 rat:'; con firmed a previous trial (using fewer rats) in which vinyl chloride van seen to have an oncogenic effect. Specifically,wifter 100 weeks, an increased incidence of mammary neoplascs (43 of 300"rats) was observed. At the lower concentrations, a carcinogenic effect (i.e., mammary tumors) was also seen. This office is evaluating these findings with regard to occupational'ex posure and with particularly emphasis on possible effects among women in the workplace.* Roscoe K Moore, Jr., l\! :Zd 01 AON 91 SCC 2-0949 9^-^'^u^n--' ^Ewp^_.CMnimMc* r- J. -^. . TEXT PROPOSED iY THE COMMISSION OF _ THE EUROPEAN COMMUNITIES . ''*'* '-^O'-"- TEXT AMENDED BY THE EUROPEAN PARLIAMENT -- measuring and momtoring tcchniqucs necessary for this purpose, as well as other preventive - (v; measures, '-- guidelines for medical surveillance. Article 2 unchanged Article 3 3.1. The fundamental aim of technical monitoring shall be to reduce to below measurable levels the atmospheric concentrations of VCM to which c workers are exposed. All working areas in works referred to in Article 1.1 shall therefore be monitored 4^ . for.the presence of VCM. 3.2. For new VCM/PVC work^, a maximum atmospheric concentration o 5 ppm, which may not be exceeded, shall be laid oowrr^as the technical long-term limit value for VCM. 33. For existing VCM/PVC works, a maximum atmospheric concentration of 10 ppm, which may not be exceeded, shall be laid down as the technical long-term limit value for VCM. 3.4. The necessary technical measures with respect to the limiting technical values given under 33 and 33 shall not in any case result in VCM pollution of the environment outside the works. Article 3 3.1. unchanged 3.2, For new VCM/PVC works, a maximum atmospheric concentration of 1 ppm, which may not be exceeded, shall be laid aown'as the technical long-term limit value for VCM. 33. Existing VCM/PVC works shall be allowed an adjustment period of up to one year. 3.4. The necessary technical measures with respect to the limiting technical values given under 33 shall not in any case result in VCM pollution of die environment outside the works. The emission and immission problems arising in connection with the implementation of this Directive are to be dealt with in a separate Directive. Articles 4 ai d 5 unchanged Article 6 A monitoring system which gives continuous mean values for at least one hour shall be provided to detea abnormal increases in concentration levels caused by technical failures in working areas in works producing VCM/PVC. 6.1. The threshold concentration at which the alarm is triggered shall depend on the measuring system and on operating conditions. Article 6 ;:r? A monitoring system which gives continuous mean values for at least one hour shall be provided to detea abnormal increases m concentration levels caused by technical failures in working areas in works producing VCM/PVC. .., :y 6.1. unchanged ~ 0->- . ' C.f.-r < 63. An increase in VCM concentration shall be regarded as abnormal when it exceeds approximately 63. unchanged five times the mean weekly value. In such an event, technical measures to discover the causes shall be taken without delay. } - jy SCC 2-0950 m i fr. Urges the Commission to work out a Community reference method in order to check the VCM measuring systems so that the workers concerned are not exposed to VCM concentrations -reaching the scientifically acknowledged danger thresholds; . ' ' : . 5, Takes the view that, for the purpose of determining the maximum concentration to be laid down as the 'technical long-term limit value', no distinction should be made, except for the adjustment period provided for, between existing and new VCM/PVC production units; . : 6, Brieves that the area of application of this Directive should be extended to workers in the PVC processing sector;-,. . ' ' .. 7. Shares the Commission's view that-the maintenance of the estabjished. Umir value should on no account result in VCM pollution.^ rh environment outside the works: requests the Commission, however, to deal in a separate Directive with the emission and immission problems which arise in this connection; 8. Believes it essential that the present Directive be continually revised in the light of developments in technology and occupational medicine and that Parliament always be consulted on such revisions; 9. Asks the Commission therefore to make the following amendments to its proposal pursuant to the second. paragraph of Article 149 of the EEC Treaty. text morosED by the commission of THE EUROPEAN COMMUNITIES TEXT AMENDED BY THE EUROPEAN PARLIAMENT v>. Council Directive on the approximation of Member States' laws, regulations and administrative provisions on the protection of the health of workers occupationally exposed to vinyl chloride monomer Preamble and recitals unchanged Article 1 1. The object of this Directive is the protection of workers employed in works in which: -- vinyl chloride monomer, hereinafter referred to as VCM, is produced, reclaimed, stored, discharged into containers, transported or used in some other - way, ' -- vinyl chloride monomer is converted into unformed vinyl chloride polymers, hereinafter referred to as PVC, who are exposed to the effects of VCM in their working area. 2. This protection shall, be 'ensured by the establishment of: -- limit values for the atmospheric concentration of VCM in the working area. Article I 1. The object of this Directive is die protection of porkers employed in works in which: -- vinyl chloride monomer, hereinafter referred to as VCM, is produced, reclaimed, scored, discharged into containers, transported or used in some ocher way, -- vinyl . chloride monomer is converted into unformed vinyl chloride polymers, hereinafter referred to as PVC and into finished products, who are exposed to the effects of VCM in their working area. 2. unchanged (l) For complete text, see OJ No C 291, 10. 12.1976, p. 5. _ ^^~^NaC 163/15 .'V V-; --. .-:* l -- ...... TEXT PROPOSED BY THE COMMISSION OF --V , - " THE EUROPEAN COMMUNITIES TEXT AMENDED BY THE EUROPEAN PARLIAMENT 13.2. Member States shall communicate to the Commission , the. texts of the main provisions of ..national law which they adopt in the Held covered by -this Directive. ' _ ' - 13.2 unchanged - Article 14 unchanged Annex I to be amended in accordance with Article 3.2 Annex II unchanged Prevention of accidents at work Mr Masullo moved the oral question with debate which, together with Mrs Goutmann, Mr PistiUo, Mrs Squardalupt and Mr Veronesi, he had put to the Commission on institutions and norms for the prevention of accidents at work (Doc. 137/77). Mr Vredeling, Vice-President of the Commission, answered the question. Agenda for next sitting The President announced the following agenda for the next sitting on Tuesday, 14 June 1977: 10 a.m. end 3 pen.: -- Lautenschlager report on a European Cooperation Grouping; -- Couste report on double taxation; -- Jahn report on bird conservation; -- oral question with debate to the Commission and and Council on recruitment policy; -- Osborn report on the annual accounts of railway undertakings (without debate); -- oral question with debate to the Commission o** safety standards for hotels. 3 p.nt.: -- Question Time The sitting was closed at 830 p.m. H. R. NORD Secretary-General Emilio COLOMBO President imi? ( see 2-0952 rrrmmfm Official Jourhai of the EuropcatTCominjinidcs \'r . TEXT PROPOSED BY THE COMMISSION, OF THE EUROPEAN COMMUNITIES TEXT AMENDED BY THE EUROPEAN PARLIAMENT 63. , The alSrm threshold shall not, however, be' greater tha(n 40 ppm. If this value is exceeded,. , - technical anH personal protective measures shall be taken without delay. 0 , 63. The alarnnhs^hold shall not, however, be greater thajiMO ppm.\As soon as this value.is exceeded, tcchhieal.and-personal protective measures shall be taken without delay. Articles 7 and 8 unchanged Article 9 9.1. A register shall be kept of workers employed on operations described in Article 1.1,. with particulars of the type and duration of work, and the resulting exposure. A copy of this register shall be given to the industrial medical officer responsible for surveillance, unless the register is kept by the officer himself. Article 9 9.1. A register shall be kept of .workers employed on operations described in Article 1.1, with particulars of the type and duration of work, and the resulting exposure. A copy of this register shall be given to the industrial medical officer responsible for health protection at work, unless the register is kept by them. 93. The register referred to in subparagraph 1 shall be open to inspection by workers and their representatives. Article 10 unchanged Article 11 11.1. This Directive shall be reviewed at least every two years in the light of developments in technology and occupational medicine. i 11.2. A Committee consisting of representatives of the Member Stares, with a representative of the Commission as chairman shall be set up for this purpose. UJ. The Committee shall draw up its own Rules of Procedure. Article 11 11.1. This Directive shall be reviewed at least every two years in the light of development? in technology and occupational medicine. Parliament shall be consulted on such revisions. 11.2. unchanged 113. unchanged Article 12 unchanged Article 13 13.1. Member Staces shall bring into force the laws, regulations and administrative provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof. Article 13 13.1. Member States shall bring into force the laws, regulations and administrative provisions needed in order to comply with this Directive wichin eight months of its notification and shall forthwith inform the Commission thereof. see 2-0953 13.2. Member States shall'communicate to:^he ....... 13.2 Commission the texts of the .main provisions-of national law which they adopt in the field covered by this Directive. - ........ ' . unchanged Article 14 unchanged r Annex I to be amended! n. accordance :w i t h Artie 1 e 3.2 k f. I. Annex II unchanged ' \I Prevention of accidents at work Mr Masullo moved the oral question with debate which, together with Mrs Goutmann, Mr Pistillo, Mrs Squarrialupt and Mr Veronesi, he had put to the Commission on institutions and norms for the prevention of accidents at work (Doc. 137/77). Mr Vredeling, Vice-President of the Commission, answered the question. Agenda for next sitting The President announced the following agenda for the next sitting on Tuesday, 14 June 1977: 10 a.m. and 3 pan.: -- Lautenschlager report on a Cooperation Grouping; W -- Cousti report on double taxation; European -- Jahn report on bird conservation; -- oral question with debate to the Commission and and Council on recruitment policy; -- Osborn report on the annual accounts of railway undertakings (without debate); -- oral question with debate to the Commission oi safety standards for hotels. 3 pjtt.: -- Question Time . The sitting was closed at 830 p.m. it i i H. R. NORD Emilio COLOMBO Secretary-General President see -0^54 > // "bents; however, another 20% offer no courses, The body material damaged by the proximal traneous agent) over a short time span have however short on polymers. Two objectives should be distinguished; one is to provide chemistry majors with an adequate chemical may be regenerated (as has been shown, for example, in the case of DNA dam aged by ionizing radiation or similar agents); 3. significance for man. Neither cause and effect, ' nor epidemiology (In my view) has approached ' the degree of definitfvity we now have with re- and comprehensive understanding of polymers, differences In metabolism--body chemistry-- sped to cigarette smoking.. -- both natural and synthetic; the second is to between animal and man (vitamin C, not required If this essay appears to challenge the "any : provide a fully polymer-grounded degree struc by the rat, is an example of such a difference). amount" and "any animal" phrases in the De ture. We have favored the latter and our expe To these may be added a physiological factor laney amendment. It is so Intended. rience is that a satisfying treatment necessitates differences in rate of excretion of either the Waldo E. Cohn blending the physics and technology of polymers original chemical or the proximal material Senior Biochemist (retired). Biology Division, - along with their chemistry. This leads to a formed from It (I realize that this can be re Oak Ridge National Laboratory. teaching program firmly based on chemistry, garded as a special case of point 3 above.) I physics, and mathematics which leads to an discuss each of ihese briefly below. Integrated view of polymer science in both its 1. Detoxification mechanisms for many CHEMICAL SAFETY "pure" and "applied" aspects, in turn, this ap classes of mnatrnl compounds (hydrocarbons, proach has caused the formation of separate drugs, etc.) are known. Further, many such In support of Dr. de Jongh polymer departments, as at Manchester, or of compounds cause an increase in the enzyme Interdepartmental structures. systems that do the detoxification; `Tolerance" SR I wish to si^jport the warning of Dr. H. A. P. Alas, like Or. Wicks, we find the current to certain drugs Is based on this body reaction de Jongh (CAEN, Aug. 1, page 31) that ail re problem to lie In the availability of students. The to the foreign substance. When an organism that ductions with hydrides be carried out in a nitro past few years have seen a decline in entrants has not buHt up that tolerance Is suddenly gen or other inert atmosphere. The same holds at the B.Sc. level while Ihe M.Sc. course attracts overwhelmed by large doses, the result may be for hydroborations, transformations of organo- many more overseas than home students; this quite (Afferent from that occasioned by repeated boranes, Grfgnard reactions, and those of most is a national trend, not just endemic to Man small doses: The existing body defense mech organometalllcs, even though many of these can chester. One is saddened by the reluctance of anisms are overwhelmed, and the body has no be carried but without an inert atmosphere with students to take up an area of education which, time to develop the Inducible defense mecha only minor losses fai yields. In the case of the despite its apparent specialization, in reality nisms (enzyme systems). 3 NaBHt/AiCfj reagent in cSglyme, tests showed offers a balanced and Integrated science edu 2. Repair, tike the Induction of detoxification that the reagent was stable to dry air and did not cation-end produces graduates for whom there systems, takes time. The concept here Is similar Inflame when poured through air {J. Am. Chem is a real demand, even by industry In reces- to the detoxification Induction mentioned abqye: Soc78, 2582). However, these tests were The greater the damage, or the more extensive . performed with the dear, dry solution. Our so Dr. G. J. Howard the damage, ihe longer repair will take (skin cuts lutions were prepared by mixing a dear solution in Polymer andFijre Scienoe, University or abrasions exemplify this). Major short-term of AlC^ln diglyma with a dear solution of NaBHj of Manchester damage may overtax the repair mechanism, in diglyme. I agree with de Jongh that the pres leading to irreversible changes (death, cancer), ence of water, solid AfC^, and possibly sodium Validity of animal testing whereas the same total insult, spread over a borohydride, indicated as present in the reaction longer time, may be repaired as fast as the mixture that exploded, could produce a hydro SIR: As a now-retired, but for nearly 40 years a damage is incurred (the same as for the detoxi gen-air mixture in the explosive range, ignited research biochemist, (.have serious reservations fication mechanism described above). by spontaneously inflammable materials pro as to the validity of the animal tests so widely 3. Differences in metabolism between duced fat the Interaction of solid AJCI3 with NaBH< mentioned as Indicating or proving the carci species are common. The rat can synthesize (J. Am. Chem. Soc., 75, 209). nogenicity of saccharin in man. I have dteassed vitamin C; the guinea pig (and man) cannot Man Herbert C. Brown these reservations with other qualified bio has a Wgh-potasslum, low-sotfun red blood ceO; Purdue University, West Lafayette, Ind. chemists and find them in complete agree in the dog, we find the reverse. There is no ment. reason to believe that the chemical reactions, Inhaling alkylating compounds It is now well known that the Induction of from administered substance to its excretory cancer by chemicals, or even by ionizing ra product (or to its "proximal" ktsuft form), will be SR: The Journal of the American Medical As diation, Is a chemical process--that is to say. identical In rat (or any animal) and man. Even sociation for July 25, 1977, page 356 has ab Is a process Involving one or more chemical within man, we find (Afferent rates of reaction for stracted the following article from Deutsche reactions, the first of which involves the so- the same enzyme system between one tissue Medizinische Wochenschrifti "Occupational called proximal carcinogen. Chemical reactions and another. . Lung Cancer after Inhalation of Alkylating proceed at rates proportional to the concentra p I have been given to understand that the rat Compounds: Dichiordimethyl Ether, Mono- tion of the reactants: The higher the initial con holds urine in the bladder longer, proportionally, chlordimethyl Ether, and Dimethyl Sulfate, U. centration, the faster the reaction, and the hitter than does man. This would be one more preju Bettendorf. A 42-year-old chemist died from the concentration or amount of product Any dicial factor: High concentration, for the first two extensive pulmonary carcinoma, having Inhaled subsequent reactions will likewise be acceler reasons given above, and long time of exposure for over seven years dlchlordimethyl ether and ated, and any final product (the proximal car would probably yield, even fat the same species, smaS amounts of dimethyl sulfate. This exposure cinogen) will be more rapidly accumulated or a different result from low concentration and took place in circumstances that. In animal ex increased in amount, and the "effect" (cancer) short time of exposure. And repair could not periments, have led to the development of more likely to appear. This, of course, is the keep up. (I might note here that cflabetics and cancer. A causal connection between the oc basis of the so-called Canadian tests as well as those ingesting large amounts of fluid--as In cupational exposure to these chemicals and others: Large amounts for a short time equals "diet" drinks--excrete a more dilute urine and carcinogenesis is Implicated." all amounts for a long time. excrete more urine than others; their exposure Ctowever. this simple reasoning Ignores three Is thus lessened.) ;ie biochemical facts: 1. detoxification *" For all these reasons, (contend that there are mechanisms, many of which are known, and valid scientific grounds for challenging the as i thought a note on this would be of value to any unwary chemists working with these com pounds. Joseph D. Teller which can be overwhelmed by large amounts of sertion that the "Canadian" tests, or others in Worthington Biochemical Carp., Freehold, the toxic substance; 2. "repair" mechanisms: volving targe amounts of saccharin (or any ex NJ. Aug. 29, 1977 CAEN 5