Document by380a8bpJDOKq6aNNvox0apg

JOSEPH E. KELLEH JEROME H. HECKMAN CHARLES H. MEEHAN WILLIAM H, BORGHESANI, JR. ROBERT R. TIERNAN WAYNE V. BLACK DAVID L. HI LX MARTIN W BERCOVICI EDWIN B SPIEVACK PETER M. NEMKOV JOSEPH E, HADLEY CAROLE C. HARRIS WILLIAM W, PUGH LAW OFFICES WASHINGTON, D.C, 20036 April 15, 1974 .W. A. K. APR 1 3 1974 TELEPHONE BOB S90-S7OO CABLE ADDRESS 'KELMAN' TO; All Members of: SPI Food, Drug and Cosmetic Packaging Materials Committee; General Polyvinyl Chloride Interest Mailing List; Ad Hoc Liquor Bottle Committee; Plastic Pipe Institute (Executive Board); Plastic Bottle Institute (Voting Representatives); SPI Executive Committee; SPI Public Affairs Committee RE; Polyvinyl Chloride Prior-Sanctioned Status, Proposed Rulemaking Gentlemen To put it mildly, the past week has seen a continuing and somewhat intensifying concern over the entire vinyl chloride monomer and polyvinyl chloride resins problem. Again, it is difficult to encapsulate everything that is taking place but we shall try to continue to post you in as telegraphic a style as pos sible with a weekly letter. In this instance, we are actually sending two letters for reasons hereinafter explained. As far as indicated action is concerned, we ask that you pay particular attention to the separate letter being sent herewith. The reason for the separate letter is so that copies could be sent to the Food and Drug Administration thereby enabling us to comply with a request that we circulate all known contacts in an attempt to see that FDA gets information it believes needed as promptly as possible. ASI-PR 0002088 .pril 15, 1974 Page Two Taking the FDA situation first, although it may not really be the most critical in some respects, we are now seeing what amounts to something of a develop ing panic in bureaucratic circles. We can imagine how much pressure the Food and Drug Administration Staff is experiencing because we spent the better part of last week taking your PVC telephone calls ourselves. In ad dition, we know from our sources at FDA that it is receiving a multitude of calls from all sorts of industry representatives advising it about the ubiquitousness of the use of PVC, and the fact that any unduly restrictive action could create chaos. Just for example, we were told that one trade association chief executive advised the agency that if its regulatory efforts were not carefully considered, the entire country could begin suffering a protein shortage due to the shortage of appropriate alter native materials for the packaging of meat and other food products. What all of this expression of concern has led to is an increase (perhaps not really necessary since the situation has been recognized as critical for some time) in FDA's feeling that it needs more information and should proceed as responsibly as possible. Nevertheless, the pressure from so-called consumer interests is intense. In any event, the week's events led to our receiving something of a startling telephone call late Friday afternoon requesting that a select group of technical personnel from companies representing some sort of crosssection of interests in the use of PVC be called together for a meeting on Friday, April 19. A number of telephone conversations took place immediately thereafter. The fact is that we advised the FDA Staff we were anxious to cooperate but certainly could not select a group of no more than 40 persons for a meeting intended to develop broad-based tech nical data about the resins; food, drug and cosmetic packaging; and devices areas. Indeed, I informed our contacts on the Staff that were such a meeting called, we would need to have considerable additional notice, would be required by our / ASI-PR 0002089 April 15, 1974 Page Three obligations to inform all of you, and that this would pro bably lead to FDA's being literally swamped with requests to attend any session held. The net result was that Dr. Schaffner of the Office of Technology who is playing a leading role in over seeing the PVC question from the food, drug, cosmetic and device point of view has at least temporarily withdrawn from the meeting idea in favor of our sending out the enclosed letter. This is why you will note that copies of the letter have been directed to Dr. Schaffner, and Messrs. Ronk and McCowin who continue to have the assignment of trying to resolve the Food and Drug Administration situation. Finally, I might point out that Mr. Ronk advises that FDA is still hopeful of publishing a Proposed Regula tion in the Federal Register "in the next two or three weeks." The only other bit of information relating to FDA activity which might interest you is included in the attached reproduction of an HEW News Release dated April 3, but received here in the middle of last week. Turning to the other PVC "fronts," as of now we consider the Occupational Safety and Health Adminis tration (OSHA) problem the most critical. As you know from last week's letter, the temporary OSHA standards allow for a 50 ppm upper limit in the vinyl monomer and polyvinyl chloride production environments. There is now reason to believe that the ultimate limits will more closely follow the recommendations of the National Institute for Occupa tional Safety and Health (NIOSH) which call for a virtually zero tolerance. Some of you may not have seen the NIOSH recommendations so a copy of the March 11, 1974 version is enclosed. During the course of this week meetings of vinyl monomer and PVC producers are scheduled so there will pro bably be more to report in this area in due course. Mean while, there is some concern that OSHA will be moving more promptly than had originally been anticipated with respect to final and much more stringent regulations. We would ASI-PR 0002090 April 15, 1974 Page Four prefer not to speculate unduly in this regard so we hope you will await further word from us on the subject without calling for our "guesstimates" as to what might happen. In the realm of "in case you didn't see the items" and "for your information" reports, we are enclosing (1) a Washington Post article dated April 10 entitled "'Killer Chemicals' In Hair Spray?" and (2) a copy of a letter and extract of proceedings in Parliament graciously and alertly supplied to me by our associate counsel in the United Kingdom. These enclosures will probably be of some interest. The Post article does not really contain any thing new but will demonstrate the kind of publicity which is bound to give rise to increasing pressures. The report from Mr. Gamon will simply indicate to you that the British, as might be anticipated, are being a good bit more calm about the problem than are some of ficials here and elsewhere in the world. You might even find the excerpt from the Parliamentary report helpful in providing some reassurance to your contacts. It should again be recalled that, as of now, PVC remains prior sanctioned for all uses in this country and is likely to remain so during the time it takes for the Food and Drug Administration to issue its expected pro posal, receive comments and data thereon, perhaps even hold a legislative-type hearing (another suggestion that came up when the idea of a "select group" meeting was thrust upon us suddenly last Friday evening), and finalized Rulemaking is adopted. We will continue to be in touch as matters pro ceed and will also do our best to be responsive to your inquiries in the meantime. We do want to urge that as many of you as can possibly do so respond to the call for help set forth in our separate letter, and that if you do send ASI-PR 0002091 *-pril 15, 1974 Page Five data directly to FDA, you supply us with copies of anything submitted to the extent that this is feasible. Enclosures / ASI-PR 0002092 JOSEPH E. KELLEB JEROME H- HECKMAN CHARLES M. MEEHAN WILLIAM H. BORGHESANI, JR ROBERT H.TIERNAN WAYNE V. BLACK DAVID L. HILL MARTIN W BERCOVICI EDWIN B SPIEVACK PETER M, NEMKOV JOSEPH K, HADLEY CAROLE C. HARRIS WILLIAM W PUGH LAW OFFICES WASHINGTON, D. C. 2003Q TELEPHONE sos eoe-szoo CABLE ADDRESS"KELHAN" TO: All Members of: SPI Food, Drug and Cosmetic Packaging Materials Committee; General Polyvinyl Chloride Interest Mailing List; Ad Hoc Liquor Bottle Committee; Plastic Pipe Institute (Executive Board); Plastic Bottle Division (Voting Representatives); SPI Executive Committee; SPI Public Affairs Committee RE: Prior Sanctioned PVC Status; Proposed Rulemaking; Additional Analytical Information Request Gentlemen On Friday, April 12, 1974 we delivered to the Food and Drug Administration on behalf of The Society of the Plastics Industry, Inc. additional analytical information supplied to us by M & T Chemicals, Inc.; the data was designed to aid FDA in its quest for suitable methodology to specify in its anticipated rulemaking proposal on PVC. During the course of discussions about the data, the Food and Drug Administration indicated its urgent need for additional information regarding a number of related aspects of the polyvinyl chloride packaging materials matter. While the FDA staff members did not "demand" this information, it was repeatedly urged that the information be provided promptly so that the Agency will not find it necessary to use its powers to "demand" on a company-by-company basis. This letter, therefore, ASI-PR 0002093 2 should be considered a most urgent request for action by all interested or involved parties. The basic FDA position, as we understand it, is that it needs the requested information in order to soundly evaluate the extent of the public health problem. With facts at hand, FDA can react responsively suiting its response to the actual need. Without facts, its re sponse will have to be extremely broad and probably severely stringent to encompass any possible or conceivable hazard. SPI has provided gas chromatographic analytical methods which were believed to be suitable for regulatory purposes and is now providing supplemental amendments to improve one of the methods in line with FDA requirements. However, the Food and Drug Administration has received indications that other analytical procedures differing in the nature of the column packing detector, or even based on different analytical principles are being used to deter mine vinyl monomer either as residues in polyvinyl chloride resins and plastic materials, or as a migrant into foods and food simulating solvents. The first FDA request is that all those doing analytical work involving vinyl chloride monomer submit the procedures being used to the Food and Drug Administration as a part of the write-up of any such procedures; chromatograms and calibration curves should be included so that FDA personnel can independently assess the utility of the analytical method. The written procedures should include all necessary manipulative details that have been developed to minimize or eliminate loss of vinyl chloride monomer from the calibration standards of the samples being analyzed; and a full description of the instrumentation including all necessary instrument operating parameters such as column packings, temperatures, gas flows, sample sizes, and instrument settings to the extent that these influence the signal intensity. Further, the chromatograms should be adequately labeled to indicate the point of sample injection, a time scale, the sample identification, the sample size, and instrument settings that may affect the signal height. A second type of data requested by the Food and Drug Administration concerns the residual monomer level in typical PVC materials; this concerns not only food contact ASI~pft 0002094 3 materials including potable water pipe, but also drug and cosmetic materials. In particular, the Food and Drug Administration wants to know what the residual monomer levels are in the rigid and/or flexible packag ing materials in the form in which they contact food or fluids that enter the body. For example, this means the residual monomer content of flexible film used as a food wrap, of fused plastisol used as gaskets or cap liners for closures, of vinyl can enamels after application and baking, of PVC pipe (both new and old), and of bottles. I In addition, one might say especially, the Food and Qrug (Administration urgently needs residual monomer data in ,PVC tubing used in milk handling as in milking machines, jand in PVC compounds (tubing and sheet material) used in jmedical applications such as blood bags, IV sets and any other medical application (drug or device) where there is jany reasonable possibility that residual monomer (if any) from the PVC item might enter the human body by any route. These data should be submitted along with the methodology employed, complete with calibration and validation data, and properly labeled chromatograms. The third area on which the Food and Drug Admini stration needs specific information pertains to monomer migration. Here it is requesting information on monomer migration from the various classes of fabricated products discussed in the preceding paragraph into appropriate foods, food simulating solvents, or medical fluids. Of particular interest to the Food and Drug Administration is specific information regarding the migration of vinyl chloride monomer into milk and into medical or body fluids which may have contacted PVC fabricated products. In supplying this information, the reports should include a description of the analytical procedures used, calibration and validation data, and typical chromatograms obtained during calibration and during analysis itself. You will all recognize that summaries of some of the type of information requested have already been sub mitted to the Food and Drug Administration. What it seeks now is specific information from each manufacturer concerning its products so that some type of overall assessment can be made of whether there now exists a public health problem with respect to monomer migration to foods, drugs, or cos metics and whether any of these areas would require special / ASI-PR 0002095 4 regulatory attention either immediately or in the future. The Food and Drug Administration also recognizes that in some cases complete information is not available but it would rather have fragmentary preliminary information now and obtain complete details and data later than wait for polished reports at some time in the future. It may be of interest to you to know that we are distributing this letter as broadly as possible at the specific request of the Food and Drug Administration. Be fore making this request to us, the Food and Drug Administra tion had originally planned to convene a meeting on short notice to which it planned to invite fifteen or twenty of the "leading" companies in various aspects of the industry including some resin producers, compounders, manufacturers cf bottles, film and sheeting, tubing; and users of Such products such as food packages and several drug firms. The Food and Drug Administration requested our assistance in compiling such a list and we informed it that we were utterly unable to make a judgement since so many companies are vitally interested in the matter. Rather than call such a meeting, therefore, the Food and Drug Administration decided to try to obtain the information it needed by means of this letter and by directly contacting other companies who might be involved, and yet not be on our extensive circulating list. Those of you who wish to respond to the foregoing request for information should send your reports either to us for forwarding to the Food and Drug Administration or directly to: Mr. Gerad L. McCowin Division of Food and Color Additives Food and Drug Administration 200 C Street, S.W. Washington, D.C. 20204 Cordially yours. cc: Dr. R. Schaffner Director, Office of Food Technology, FDA Mr. G. McCowin Assistant to Director Division of Food and Color Additives, FDA Mr. R. Ronk Director, Division of Food and Color Additives, FDA Dr. C. Jelinek Director, Division of Chemical Technology, FDA ASI-PR 0002096 U. S. DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE 74-23 FOR IMMEDIATE RELEASE April 3, 1974 (Food and Drug Administration] BERRETH--(301)--443-3285 (Home)--(301)--869-1795 The Food and Drug Administration today initiated action to insure, that vinyl chloride is not used in any aerosolized food, drug or cosmetic product, Vinyl chloride is a gaseous substance used to produce a type of plastic called polyvinyl chloride (PVC). It has also been used as the propellant in aerosol products. The substance has been associated with ten cases of a rare liver cancer among U.S. industrial workers exposed to the chemical over extended periods of time. Use of vinyl chloride in aerosol products regulated by FDA has been minimal. FDA is unaware of any past or present use of the substance in aero solized food products. Such use would require prior FDA approval, and no such approvals have been given. FDA is also unaware of any present use in aerosolized cosmetic or drug products. The Agency has, however, learned of two cosmetic manufacturers and one drug manufacturer who used vinyl chloride as a propellant before June of 1973. Although little is likely to remain on the market, FDA is re questing the manufacturers to recall the products as a precautionary measure. (Specific details on any products being recalled will be provided as they are developed and published on FDA's Weekly List of Recalls.) MORE ASI-PR 0002097 Page 2 FDA will use the Drug Listing Act of 19.72 to require manufacturers of drugs to provide information on any aerosolized drug products which contain vinyl chloride. The Agency has also written to all known^cosmetic manufacturers requesting them to identify products which contain the sub stance. Recalls will be requested if necessary. The use of PVC as a food packaging material has been under active FDA investigation since May of 1973, when the Agency learned that VC monomer was leaching from plastic liquor bottles -into the liquor. FDA immediately proposed to ban PVC packaging of alcohol-containing food or beverages a?nd, concurrently, the Bureau of Alcohol, Tobacco and Firearms ended the experi mental use of such bottles for packaging liquor. FDA is currently reviewing data and comments which have been submitted in response to the May proposal. The Agency is also looking at other foods packaged in PVC containers to determine if a similar leaching problem exists. The FDA actions announced today will formally be issued in the FEDERAL REGISTER next week. #### / ASI-PR 0002098 RECOMMENDED OCCUPATIONAL HEALTH STANDARD FOR THE MANUFACTURE OF SYNTHETIC POLYMER FROM VINYL CHLORIDE MARCH 11, 1974 U. S.' DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service Center for Disease Control National Institute for Occupational Safety and Health PR 0002099 ASI 1. SCOPE AND APPLICATION This standard regulates the manufacture of synthetic polymer from vinyl chloride (chloroethene, Chemical Abstracts Registry No. 75014), in order to protect the health and safety of workers. Vinyl chloride also known as vinyl chloride monomer (VCM), chloroethylcne and chloroethene, is a colorless sweet smelling gas at ordinary temperature and pressure and has a boiling and melting point at one atmosphere of -13.8C, and -153.71C, respectively. Its chemical formula is Cl^CilCl and it has a molecular weight of 62.50. Although noncorrosive at normal atmospheric temperatures, in contact with water and at elevated temperatures it accelerates the corrosion of iron and steel. Of considerable concern is the fact that vinyl chloride is easily ignited and has a lower and upper explosive limit of 3.6% and 26.4%, respectively. 2. DEFINITIONS For the purpose of this standard: ` a. "Assistant Secretary" means the Assistant Secretary for Occupational Safety and Health, U.S. Department of Labor or any person directed by him. b. "Director" means the Director, National Institute for Occupational Safety and Health, or any person directed by him or the Secretary of Health, Education, and Welfare to act for the Director. c. "Authorized employee" means an employee whose duties require him to be in the regulated area and who has been specifically assigned by the employer. d. "Detectable levels" means the determination that airborne concentrations of vinyl chloride are in excess of the limit of sensitivity of the sampling and analytical method recommended by the Director. e. "Clean change room" means a room where employees put on clean clothing; clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities are otherwise required in this standard. ' f. "Closed container" is any container which is used to prevent the physical contact of employees with material containing vinyl chloride monomer. g. "Closed system" means an operation involving vinyl chloride where containment prevents the release of vinyl chloride into regulated areas, nonregulated areas, or the external environment. h. "Contaminated" refers to detectable levels of vinyl chloride monomer. ASI-PR 0002100 2 i. "Decontamination" means the inactivation of vinyl chloride to less than detectable levels or its safe disposal. j. "Disposal" means the safe removal of vinyl chloride from the work environment. k. "Emergency" means an unforeseen circumstance or set of circumstances, such as a ruptured transfer line, resulting in the release of vinyl chloride sufficient to produce acute symptoms among workers exposed or having contact with the vinyl chloride. l. "External environment" means any environment external to regulated and nonregulated areas. m. "Regulated area" means an area where entry to and exit from a vinyl chloride workplace is restricted and controlled. 1 n. "Nonregulated area" means any area under the control of the employer where entry and exit is neither restricted nor controlled. - o. "Protective clothing" means clothing designed to protect an employee agains contact with or exposure to vinyl chloride. p. "Waste resin" means any resin or other vinyl chloride reaction product which has been removed from vessels during clean-up operations, or which has been collected as a result of in-plant housekeeping operations. 3. REQUIREMENTS FOR REGULATED AREAS A regulated area shall be established where synthetic resins containing vinyl chloride are manufactured. These regulated areas shall include but are not limited to vinyl chloride loading or unloading operations, storage, and transfer facilities; synthetic resin polymerization processes and operations; and resin handling, compounding, packaging and storage areas. Access shall be restricted to authorized employees only. All such regulated areas shall be controlled in accordance with the following requirements. a. Routine Operations (i) Initial concentration of vinyl chloride in all regulated areas shall be determined by performing air measurements at strategic sampling points under normal operating conditions. These initial sampling points must be selected by a professional industrial hygienist and will sdrve as monitoring locations for future environmental measurements. /' ASI-PR 0002101 3 The sampling pattern shall be adequate to represent the environment of the controlled area. (ii) Where detectable levels of vinyl chloride are measured, a Control Plan to reduce such levels shall be developed and implemented. The Plan shall consist not only of establishing goals for reducing vinyl chloride levels by designing and introducing engineering and process controls, but shall also identify plans for developing additional (healthful) work practices. Target dates shall be established for all goals and the Plan must be updated at least on an annual basis. Copies of the Control Plan shall be posted in all regulated areas and be provided to all authorized employees. (iii) There shall be periodic tests for process or equipment leaks and for emission of vinyl chloride which may result from work practices. The frequency of these tests shall be such as to insurd the integrity of equipment, adherence to proper work practices, and to determine achievement of the goals of the Control Plan. Tests shall be performed at each sampling point at least daily or more frequently if concentrations of vinyl chloride are in excess of those established in the Plan. When such levels are exceeded, additional samples to identify sources of contamination shall be taken. Results of all such tests shall be made available to authorized employees in such a manner as to evaluate achievement of goals contained in the Control Plan. (iv) Until exposures to vinyl chloride are reduced below detectable levels, employees entering any regulated area shall be provided with and required to wear and use a full-face, supplied air respirator, of the continuous flow or pressure demand type in accordance with 51910.134. (v) In operations involving loading or unloading vinyl chloride monomer from tank cars, trucks, barges, or other conveyance equipment, each transfer line and each vapor-equalizing line shall be equipped with vent connections permitting, at the completion of the transfer, pressure to be vented and the hose purged with an inert gas in such a manner to preclude any employee exposure. Specific and detailed transfer procedures shall.be developed and provided to involved employees in written form. (vi) Employees shall be provided with and required to wear, clean, full-body protective clothing (smocks, coveralls, or long-sleeved shirt -and pants), and gloves prior to entering the regulated area. (vii) Prior to each exit from a regulated area, employees shall be required to remove and leave protective clothing and equipment at the point of exit and at the last exit of the day, to place used clothing and ASI~PR 0002102 -4- equipment in impervious containers at the point of exit for purposes of decontamination or disposal. The contents of such impervious containers shall be identified as required under paragraph e(2)(i) of this standard. b. Reactor and Vessel Entry (i) A reactor and vessel entry procedure shall be developed and provided to involved employees in written form. Employees shall be familiarized with the procedure and shall be trained and rehearsed in the techniques provided for in the procedure. Emphasis shall not only be placed on concern for potential exposure to vinyl chloride but shall also include appropriate precautions for entry into confined spaces. ' (ii) Techniques shall be developed and applied to minimize to the maximal practicable extent employee exposure to vinyl chloride when opening any closed vessel. Examples of effective methods are the application of heat or suction to the vessel prior to opening, or use of sufficient exhaust ventilation around the vessel. Where operations such as cleaning or maintenance conducted inside an open vessel could result in the liberation of vinyl chloride, suitable procedures such as exhaust ventilation shall be developed and implemented to insure that vinyl chloride is not released into the general work environment. (iii) Exhaust air shall not be discharged to regulated areas, nonregulated areas, or the external environment unless decontaminated. (iv) All piping to and from the vessel shall be blanked or otherwise isolated prior to entry. (v) Employees entering the reactor or vessel shall be provided with and required to wear and use a full-face, supplied air respirator, of the continuous flow or pressure demand type in accordance with 1910.134. (vi) Employees entering the reactor or vessel where levels of vinyl chloride are monitored and are found to not exceed ambient levels external to the vessel shall be provided with and required to wear clean, full body protective clothing (coveralls or long-sleeved shirt and pants), gloves, footwear or foot coverings, and head covering. Where 'vessel levels arc in excess of ambient levels, employees shall instead be provided with and required to wear impervious clothing to prevent skin contact of vinyl chloride or other materials containing vinyl chloride. ASI-PR 0002103 / -5- (vii) After each exit from the reactor or vessel, employees shall be required to remove and leave protective clothing and equip ment at a designated point in the regulated area, and at the end of each work shift to place' used clothing and equipment in impervious but vented containers for the purpose of decontamination or disposal. The contents of such impervious containers shall be identified as required under paragraph e(2)(i) of this standard. (viii) Employees engaged in reactor cleaning or other operations involving vessel entry shall shower at the end of the work shift. c. Maintenance and Decontaminatjon Activities (i) Emphasis shall be placed upon immediate clean up*of spills, periodic inspection, prompt repair of equipment and leaks, and proper handling, storage and disposal or decontamination of materials to prevent airborne contamination and accidental skin contact with vinyl chloride. Because vinyl chloride is a gas at normal temperatures, waste materials, equipment, and other sources of the monomer in closed containers, shall not be placed in areas of excessive temperature or sunlight since build-up of internal pressure may result in rupture of the container, fire or explosion. i (ii) Waste resins or other materials contaminated with vinyl chloride shall be placed in closed containers identified as required under paragraphs e(2)(i) or (ii) of this standard. (iii) Appropriate procedures shall be developed and implemented for the decontamination and/or dispoal of all such waste material. (iv) In clean-up of leaks or spills, maintenance or repair operations on contaminated systems or equipment, or any operation involving work where direct contact with vinyl chloride monomer could result, each authorized employee involved in such operations shall be provided with and required to wear clean, impervious garments, including gloves, boots and continuous air supplied hoods in accordance with 1910.134, be decontaminated before removing the protective garments and hood; and be required to shower upon removing the protective garments and hood. d. General Regulated Area Requirements 1. Employee identification. A daily roster of employees entering regulated areas shall be .Sit;! / i ASI-PR 0002104 ! * -6- established and maintained. The rosters or a summary of the roster shall be retained for a minimum period of 20 years by the employer or successors thereto. The rosters and/or summaries shall be provided upon request to authorized representatives of the Assistant Secretary and the Director. In the event that the employer ceases business without a successor, rosters shall be forwarded by registered mail to the Director. 2. Emergencies. In an emergency, immediate measures including but not limited to the requirements of subdivisions (i), (ii), (iii), (iv), and (v) of this subparagraph shall be implemented. (i) The potentially affected area shall be evacuated as soon as the existence of the emergency has been determined. "' (ii) Hazardous conditions created by the emergency shall bo eliminated and the potentially affected area shall be decontaminated prior to the resumption of normal operations. (iii) Special medical surveillance by a physician shall be instituted within 24-hours for employees present in the potentially affected area at the time of the erne: ;;ency. A report of the medical surveillance and any treatment shall be included in the incident report, in accordance with paragraph (g)(3) of this standard, (iv) Where an employee has a known contact with liquid vinyl chloride such employee shall be required to shower as soon as possible, unless contraindicated by physical injuries. (v) An incident report on the emergency shall be reported as provided in paragraph (g)(3) of this standard. 3. Hygiene facilities and practices. (i) Storage or consumption of food, storage or use of containers of beverages, storage or application of cosmetics, smoking, storage of smoking materials, tobacco products or other products for chewing, or the chewing of such products, are prohibited in regulated areas. * (ii) Where employees wear protective clothing and equipment clean change rooms shall be provided, in accordance with 51910.141(e)(3) / ASI-PR 0002105 ( -7(iii) Where employees are required by this standard to wash, washing facilities shall be provided in accordance with 51910.141(d) (1) and (2)(ii) through (vii). (iv) Where employees are required by this standard to shower, shower facilities shall be provided in accordance with 51910.141(d)(3). 4. Contamination control. (i) Regulated areas, except for outdoor systems, shall be maintained under negative pressure with respect to nonrcgulated areas. Local exhaust ventilation may be used to satisfy this requirement. Clean tempered makeup air shall replace air removed. Exhaust air shall not be discharged to regulated areas, nonregulatcd areas, or the external environment unless decontaminated. (ii) Any equipment, material, or other item taken into or` removed from a regulated area shall be done so in a manner that does not cause contamination in nonregulated areas or the external environment (iii) Decontamination procedures shall be established and implemented to remove vinyl chloride from the surfaces of materials, equipment and the decontamination facility. e. Signs, Information, and Training 1. Signs. (i) Entrances to regulated areas shall be posted with signs bearing the legend. CANCER-SUSPECT AGENT AREA AUTHORIZED PERSONNEL ONLY (ii) Entrances to regulated areas containing operations covered in paragraph 3(c) of this standard shall be posted with signs bearing the legend: CANCER-SUSPECT AGENT IN THIS AREA. IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD REQUIRED AT ALL TIMES. AUTHORIZED PERSONNEL ONLY. AS I" PR 0002106 8 2. Container contents identification. (i) Containers of v/aste or other materials contaminated with vinyl chloride shall be labelled as follows. VINYL CHLORIDE CONTAMINATED MATERIAL CANCER SUSPECT AGENT DISPOSE OF OR DECONTAMINATE USING APPROVED PROCEDURES (ii) Containers of synthetic polymers made from vinyl chloride shall be labelled as follows. l SYNTHETIC VINYL CHLORIDE POLYMER VINYL CHLORIDE IS A CANCER SUSPECT AGENT POLYMER CONTAINS __ *% BY WEIGHT UNRHACTED VINYL CHLORIDE *(To be analytically determined by manufacturer and appropriate value entered on labels.) ASI-PR 0002107 (iii) Containers of vinyl chloride shall be labelled as follows. DANGER! VINYL CHLORIDE EXTREMELY FLAMMABLE LIQUID AND GAS UNDER PRESSURE CANCER SUSPECT AGENT HARMFUL IF INHALED MAY POLYMERIZE VIOLENTLY UNDER FIRE CONDITIONS OR LOSS OR REMOVAL OF INHIBITOR Keep away from heat, sparks, and open flame. Keep container closed. Use with adequate ventilation. Avoid breathing vapor. Avoid contact with skin. Keep cylinder out of sun and away from heat. Container should be grounded when being emptied. Never drop cylinder. FIRST AID: If inhaled, remove to fresh air. If not breathing give artificial respiration, preferably mouth-to-mouth. If breathing is difficult, give oxygen. Call a physician. In case of: Fire - Use water spray, dry chemical, or CO2. Spill or Leak - For small spills, evacuate area and permit to evaporate. For large spills or leaks, evacuate area. Dike or flush to ground and let evaporate. Do not flush to sewer because of explosion hazard. / ASI-PR 0002108 10 - 3. Training and indoctrination. (i) Each employee, prior to being authorized to enter a regulated area, shall receive a training and indoctrination program including, but not necessarily limited to: (. (a) The nature of the carcinogenic hazards of vinyl chloride monomer, including local and systemic toxicity; (b) The specific nature of the operation involving vinyl chloride monomer which could result in exposure; (c) The purpose for and application of the medical surveillance program; (d) The purpose for and application of decontamination practices and purposes; (e) The purpose for and significance of emergency practices and procedures; (f) The employee's specific role under normal operating or emergency conditions; (g) Specific information to aid the employee in recognition and evaluation of conditions and situations which may result in the release of vinyl chloride monomer; (h) The purpose for and application of specific first aid procedures and practices; (i) A review of this standard at the employee's first training and indoctrination program and annually thereafter. (ii) Specific emergency procedures shall be prescribed, and posted, and employees shall be familiarized with their terms, and rehearsed in theix application. (iii) All materials relating to the program shall be provided upon request to authorized representatives of the Assistant Secretary and the Director. f. Environmental Monitoring and Recordkeeping (i) Environmental concentrations of vinyl chloride shall be determined through the use of methods for sampling and analysis ASI-PR 0002109 (' - 11 - recommended by the Director or by methods of at least equal sensitivity. (ii) Employees or their representatives shall be provided with the opportunity to observe environmental monitoring activities and shall have access to the results. (iii) Complete and accurate records of all environmental measurements shall be maintained for at least 20 years'by the employer or successors thereto and shall be provided upon request to authorized representatives of the Assistant Secretary or the Director. g. Reports * 1. Operations. `` Within 60 days the following information shall be reported in. writing to the appropriate Occupational Safety and Health Administration (OSHA) Area Director. Any change in such information shall be similarily reported within 15 calendar days of such change. (i) A brief description and in-plant location of the area(s) regulated and the address of each regulated area. (ii) The number of employees in each regulated area, during normal operations, including maintenance activity. (iii) A copy of the Control Plan as developed under paragraph 3(a)(ii) (2) Environmental Measurements. On a semi-annual basis the results of measurements taken at strategic sampling points, presented in such a manner as to identify achievement of goals established in the Control Plan, shall be reported in writing to the appropriate OSHA Area Director. (3) Incidents. Incidents which result in the release of vinyl chloride monomer.into any area where employees may be potentially exposed shall be reported in accordance with this subparagraph. ASI-PR 0002110 12 (i) A report of the occurrence of the incident and the facts obtainable at that time including a report on any medical treatment of affected employees shall be made within 24 hours to the appropriate OSHA Area Director., (ii) A written report shall be filed with the appropriate OSHA Area Director within IS calendar days thereafter and shall include: (a) A specification of the amount of material released, the amount of time involved, and an explanation of the procedure used in determining this figure; (b) A description of the area involved, and the extent of known and possible employee exposure and area contamination; (c) A report of any medical treatment of affected employees, and any medical surveillance program implemented; and (d) An analysis of the circumstances of the incident, and measures taken or to be taken, with specific completion dates, to avoid further similar releases. h. Medical Surveillance (To be provided by NIOSH as soon as possible.) / ASI-pr 0002111 'Kilter 'UiiQmicaJs1' *y * `i~~ ; In Hair Spray? H. William Rogers '' Special to The Wa&htayton Post ,, LOUISVILLK, Ky.-An because Hie foreman was industrial killer, both there with a stranger taking proven and potential, is notes) and an earnest effort making head!: ncs here this to beat the ``killer chemical." week and im estimators be lieve the danger may have .spread across the nation lo such unlikely places as hair The vat", which are sunk en intoThe floor below from the third flot;r bewildering array of metal pipes, con- salons and family medicine duits and other industrial chest s. whatnot, are either "work- Clairol, Inc- recalled . ing" or being cleaned. . ; about 3,00,000 cans of aerosol The general foreman, an' hair spray, those labeled incongruously dapper (even Summer Blende Aerosol in his hard hat and gas Hair Spray and Miss Clairol mask) towering commander Kair Spray at the request : who knew his men by their of the Food and Drug Ad first names, v.-cut to some ministration which wants lengths to dc-.o-ihe the prin- them destroyed. cipal safety device. ' . ' *; ' ; : ., The FDA request Jinked the hair spray* to the grimy, clangorous industrial plants here and elsewhere that That device is an elab-, orate monitoring system, us ing two sets of electronic equipment. manufacture what some workers call the "killer chemical," vinyl chloride. Clairol spokesmen say vi nyl chloride was used in the aerosol propellant of the two brands recalled for about four years but was discontinued last summer. Some of the 100,COO cans, however, contain it. So far, at least 10 deaths have been linked to vinyl chloride. All have been An electronically Mn, \ trolled graph, not unlike that of a lie-detector, regis-' tered the offensive parts of vinyl cioride ia gas form in the air. - . Conventional wisdom is that anything up to 50 parts per million is satisfactory. On tills day, the highest' reading on the graph among the five working vats was IS. The rest were much' lower. . _ v rkers who died of angio sarcoma -- a rare form of livei- caticer -- after contin ued exposure to the chemical in plants that produce itjTor plastics, cosmetics, insecti cides and other household products. Clairol m a i n t ains the chance of anyone being harmed by using the hair spiny under normal condi tions is "extremely remote." Rist FDA apparently isn't so sure and is v.orred about other products as well. Five of the dead workers were members of the vinyl cioride production unit at the R, F. Goodrich Co. plant here in Louisville's sprawling, fume-ridden industrial com plex called Rubbcrtown. Almost by coiucidoure, this reporter was touring the fa tal plant area when the news of the Clairol recall came. With hard hat and gas mask, accompanied by file general /woman of the pro duction unit, the reporter found huge vats, scurrying workmen (possibly scurrying The foreman, R.S. Kinna-1 mon, insists that his instru-; ments provide complete safety. '. What happens if the' graph goes higher? ; , -' Once again, conventional' wisdom: >; Leave--and leave quickly;' Kinnamon commented: `We're a lot better off to-day. He noted, as have other Goodrich officials, that the problem--or tragedy--is in-, dustry-wide, not confined to' ' the Goodrich operations. ' . (For example, a chemical worker at the Goodyear Tire ! & Rubber Co. plant in Niag ara T ails, N.Y., died in 1961 of the same kind of liver earner that killed the five Goodrich employees here in' Louisville, 'rids was not! known unll' 1974.) But Gooutich seemsto he faking the lead in funding research that, in the custom ary officialese by the reeipi. cuts of the grant; "affords the opportunity to serve our See RECALL, S3, Col, 7 - ! THE WASHINGTON POST April 10, 1974 Iiair Spray Recalled RECALL, From B1 community by bringing to bear our already-existing scientific expertise and re search methods in regard to the apparent occupational health problem that has de veloped here . . ." The tab, so far, to. Goodrich: $300,000. . The researchers at the University of Louisville, headed by Dr. Charles Kupchella, are careful about public announcements / on the project. For one thing, both com pany and other sources point out that vynil cioride has nothing to do with the production of Goodrich tires. VC, as the plant peo ple call it, is the raw mate rial, or base, for products ranging through tectiles and plastics and, if a layman's view may be permitted, just about everything else. The description of "just about everything else" in cludes, of course, those hair sprays just now taken off the market. ; -: Meanwhile, the research continues ("it is conceivable that! this program would lead to expanded medical studies on angiosarcoma and other liver diseases, for which broader, additional support from various sources would be sought, as necessary"). Meanwhile, production of vynil choride continues in this country and in most other industrialized nations --notably West Germany and Japan. Also meanwhile, .just here in Louisville, two more men --both Goodrich workers-- have been diagnosed as vic tims of the rare liver cancer. ASI-PR 0002112 SHERWOOD ^CO. H. W. OAMON , M C c. ft. W1NSCR. T o. e. moss. J. L. OATCNBY. o.o. hobkirk. (consultant) TELEPHONE 01-030 7203 * 6524 Q EN ANNE'S CHAMBERS. A\f TOTHILL STREET. WESTMINSTER. LONDON, SWIH 9LG. 8th April, 1972]. Dear Jerry, It is sometime since I was in touch with you and I trust that life .is treating you kindly. On lookin'! at tho official report o proceedings in Parliament the other day I noticed the report of a question and answer which I thought might conceivably be of intere to you. In case it is I enclose the relevant extract from Column 409 of the Written Answers to questions appended to the House of Commons Hansard for 4th April. Jerome H. Heckman, Esq., Messrs. Keller and Heckman 1150 - 17th Street, N.W. Suite 1000, Washington D.C. 20056, U.3.A. With best wishes. Yours sincerely. ASI-pr 0002113 40% Written Artnverg .'APRU. 1974 Writftn Ainm 4\Q MiS Fined asked the Minister of Agri culture, Fisheries and Food if, in his negotiations with Great Britain's partners fn the EEC, he will seek to ensure that a-guaranteed price for beef becomes'a feature of the common agricultural policy- ^ ;> Mr. Peart: The United Kingdom will certainly aim to ensure that the common agricultural, policy-,.for beef includes features which ensure adequate returns to beef producers. ^Fbod Additives and Contaminants g 28. Mrs. Joyce Butler asked the Minis ter of Agriculture. Fisheries and Food vehat are the terms of reference of the food, additives and contaminants review of ihc;.nse of PVC (polyvinyl chloride) in food packaging; and what restriction is being put on such use while the results of the study are. awaited.. who arc receiving fuel subsidies. < and request permission to publish them. / , Mr. MoyTe: We arc considering' the effects of increased prices for fuel oils on the financial position of the British glasshouse industry but we have no knowledge of the specific inquiry'1 to which the hon. Member refers. - -o'"' - . . ,' * * i'*'v f Common Agricultural Policy ' . 30. Mr. Marten asked the. Minister of Agriculture, Fisheries and . Food , if he will make a statement on reform of the CAB. - v. : ./ : -r-v O->--j *: Mi. Buchan: A number of changes in the methods of support have heen agreed as part of the decisions on EEC farm prices reached by the. Council of Minis ters on 23rd March. The Council agreed that the review of the common agricul tural policy should continue. f Mr.- Moyle: My'Ministry's' scientists 11 ' V Barley and Pig Prices ' * \ . put in tharid a study of monomers in food.thd drink from PVC early in 1973 in the'light of information from the United State1 of America. The results have been submitted, to the Fool Addi tives ". and _ , CoiUarainarita Comm ittee which considers that at the tiny levels at 32. Sir P. Bryan asked the Minister,of Agriculture. Fisheries and1 Food if he will give figures for the average price of barley now being paid in other EEC countries and the price 'paid per live score to pig producers in those countries; which these monomers are present, and Mr. Buchan: The following is- the in view of the lack of evidence of a information: hazard to health through ingestion, there is no need* to restrict the use of PVC. Barley akd pig prices in encrAet EEC countries The matter is, however, being kept under ` - ` -.v'- , Barky Average review- . -. : . ;.-v.-1vi'f ;, pricet y ' pigprkes 7 i,-- . * * 'A * .x - - ' . -A I-'$ :I:1.`- ; 1 v';Y' '-r Country ,, i'.:-,,r iper score ' :f' laug ton* * . deadweightf | , j -.Glasshouse Producers . . i, : Denmark . ... . n.a. 4-84 Germany, 63-74 , /$'34 29. Mr. Wiggin asked the Minister of France ... ' ' 53-54 ' "'.S'OO Agriculture; Fisheries. and Food if ha Netherlands' ... 61-62 ' V;4-72 will make a further statement on his con sideration of: the present financial, diffi culties. of glasshouse producers brought on by the increase in the price. of fuel oik :^ Note: All prices .converted, from national currencies at spot rates; ;1 v * Barley prices, come from ,HGCA Weekly Bulletin and are prices delivered to selected market centres, in week ending 20th March. . > f Livcwcight pig prices are not readily available; Prices shown are for grade H pigs in week ending ' Mr. Moyle: I' would refer the Kotfi 17th March. . ,; Member to the reply given on 3rd April ter ray hon. Friend die Member for Har low (Mr. Newens). ` I1 1; ; > ; ; -i : - 33. Mr Charles Morrison- asked, tfiri 31. Mr. Wells asked the Minister of Agriculture, Fisheries and Food if he is aware of the financial difficulties of the British glasshouse industry ; and if he Minister of Agriculture. Fisheries and Food if he will takes steps to encourage the production of bread wheat in the United Kingdom. trill seek to obtain the- findings of the Mr. Buchan ? British wheat now con recent inquiry into allegations of unfair stitutes 54 per cent, of all flours com trading by Dutch and German growers pared with 28 per cent, in 1970-71. I 4 P 11 i / ASI-PR 0002114