Document dnB1LR9w2xmMa8QjE0YMV43O9

VRD 8002087526 EPIDEMIOLOGICAL STUDY OF VINYL CHLORIDE WORKERS Final Report - May 2, 1974 ' t I. SUMMARY Eight thousand three hundred and eighty four men who had had at least one year of occupational exposure to vinyl chlorr'de before December 31, 1972, were followed in a historical prospective mortality study. The major findings of the study are: 1. The overall mortality of the study population was approximately 75 percent of what would .be exp. :ted in a comparable population of U. S. males. 2. No cause of death showed a statistically significant excers over what would b,. expected in a comparable U. S. male population. 3. No new deaths identified as angiosarcoma of the liver were found. 4. All previously known Angiosarcoma deaths in the study population during the study period were found as part of the routine study procedure. 5. Cancers of the liver (primarily angiosarcoma), respiratory system, brain, and cancers of unknown pri. .ary site, as well as lymphosarcoma, occurred more often than expected in those members of the study population with the greatest exposure. Even though the excesses were not statistically significant, the findings warrant further study. 6. Other cancers occurred at lower levels than in the general male population,' with the exception of cancers of the buccal cavity and pharynx. There was an excess of these VRD 0002007527 2- - cancers, which however was inversely related to exposure. The explanation for this finding is not apparent. v rd 0 0 m m 28 THE SOCIETY Oh THE PLASTICS INDUSTRY, INC. 250 PARK AVENUE NEW YORK, NEW YORK 10017 * 212/687-2675 CHEMICALS RESEARCH MEETING NOTICE MAY 9 1974 May 7, 1974 rK TO: MEMBERS OF THE VINYL MONOMERS & PVC PRODUCERS AD HOC COWITTEE Dear Member: AC Its May 3, 1974 meeting, Che Steering Committee established an EPA Committee chaired by Warren Ferguson of Allied Chemical Corporation. Mr. Ferguson has summed up the problem we face by saying: "The OSHA requirements for vinyl chloride manufacture and use will In most cases require far higher standards of ventilation of work areas and of potential emission sources than has up to now been customary. It is reasonable to expect that EPA will establish emission standards designed to protect the general public from a newly recognized carcinogenic risk. "The current consensus of informal opinion seems to be that proven technology does not now exist for the removal of vinyl chloride from highly dilute air streams." Therefore, there is a need for qualified individuals to meet to consider the technical options available to us. In order to review the problem and discuss these technical options available to us, a meeting will be held on Monday. May 20. 1974 at the Saddle Brook Harriot, Garden State Parkway at Interstate 80. Saddle Brook. New Jersey, beginning at 11:30 a.m. You should plan on spending the major portion of the day at the meeting. Luncheon will be served, and following customary SPI practice, the attendees will be subsequently billed for their proportionate share of the meeting expenses. Please complete and return the attached attendance indication form advising who your representative will be just as soon as possible so that suitable arrangements can be made. 6Z5 00Z000I If you plan to stay at the Marriott please make your reservations directly with the hotel, mentioning you will be attending the SPI meeting. We look forward to seeing you on May 20. Cordially, Thomas J. McGrath Director of Packaging Services TJM/mn att. PLEASE COMPLETE AND RETURN TO: Mr. Thomas J. McGrath, Director of Packaging Services The Society of the Plastics Industry, Inc. 250 Park Avenue New York, New York 10017 I will / / will not / / attend the meeting of the EPA Committee of the Vinyl Monomers & PVC Producers Ad Hoc Coomlttee on Monday, May 20, 1974 at the Saddle Brook Marrlot, Garden State Parkway at Interstate 80, Saddle Brook, New Jersey, beginning at 11:30 a.m. I do / / do not / / plan to stay for lunch. NAME COMPANY ADDRESS C2 'UU. < AS1INGT0*N Vosi & fD 00U2007J45 By John Saar ' ' ' The writer is a member of the Metro "poiitah staff of The Washington Post. BEFORE IT WAS identified earlier this year as the carcinogenic killer .of 12 industrial workers, vinyl chloride ..was accepted as a cheap and almost in- .nocous gas with a varity of uses. Pressurized Into consumer-sale aerosol cans, it served as the propellant for in secticides and hairspraysr as the base ingredient in a common pJastic.'-poIy-. '..vinyl chloride (PVC>--it is omnipre, sent of everyday life as bottles, pipes, .wrapping, car upholstery, phonograph records and sundry other products. : With dramatic speed over these last ,few months, our understanding of the ; apparently compliant slave gas has been unpleasantly changed. Unmasked by an Italian research chemist, it now 7 stands convicted in the deaths by a rare and invariably fatal liver cancer '' of the .12 plastics'workers in the last 13 years. ' " * Now--in the words of one researcher --it "casts a long shadow" over the lives, of rv-ny thousands of workers in ' second-echelon, plastic-using indus- . 'tries.' And if the lethal qualities of Vviynl chloride have been overlooked by 'the manyfactureres, just how justified' - is the consumer^*'reliance on that most - . commonly; used. artificial, material--'; 'plastic?1 - * /* ; The already proven relationship be-^ -'tween vinyl chloride and'angiosarcoma --a liver cancer which generally kills * an average of only 22 persons a year in > the United States--is the latest of the ; chemical time bombs to threaten our " > Industrial vurkers and, if the forebod ings of some researchers axe borne - out, it may be worst. That suspicion.is under high priority ' Investigation by at least seven gover- , .mental and medical research groups-- . an effort one involved expert in envi- ' . ronmental health calls "unprecedented ' ' in both scope and intensity." . . ' "Potent Carcinogen"; "-^VlKYL ' CHLORIDE," ' added Dr. Irving Selikoff, a professor of ./medicine at the Mount Sinai School of "Medicine, New York and director of the*EnvironmentaI Sciences Labora tory there, "is a very potent carcino gen in the center of our great chemical process industry and a product used 'throughout society and industry." ' ,tir. Joseph A, Wagoner, working 15hour days to direct another fcev inves-wtigalion for the National Institute for ' --T--.' - .'-`."-T' e ":~r--.vfwf, . ....... u "The'.already proven re lationship between vinyl Two months ago, Dr. Selikoff took a '/ 50-strong team*of medical personnel to. ^ chloride and angiosarcoma is v'*/' the- 'latest of the chemical yy 1 -7/`- time bombs to threaten,our' ,-.r. .' --industrialivorkers," *'/the Niagara Falls, N.Y., plant where '400 men make polyvinyl chloride for .' Goodyear. He is unwilling yet to detail . y results' of the mass clinical screening' conducted there, but commented: "We /' have found problems there. We have rfound vinyl. chloride-associated dis- . 'ease." ' ' . ,'A' The vinyl chloride hazard has been 'Occupational '.Safety . and-'Health `'fNIOSH), calls vinyl chloride "one of, exposed at a quickening pace over the last few months as animal researchers ''if not the most potent,carcinogens." " With'the dangers of vinyl chloride Vestablished in' the grimmest fashion - *- found that mice and rats dosed with ^'the chemical developed angiosarcoma and medical researchers found evi- >Lby death- certificates, researches are \.i pressing with- unusual - urgency for \,kome answers, to a whole spectrum of ;,lar-reaching question. They want to / know exactly what the. health risks are for approximately* 6,500 people -!; who work in 37 plants where vinyl , ^``chloride is polymerized into polyvinyl. *?/ chloride. ' ... ; * ' Beyond that, there'is an urgent need 77 to establish the hazerds, if any, for the ..tens of thousands of other workers / who fashion the, raw PVC into prod- *. ucts and for the public at large which . r dence of the same rare tumor among ''plastics workers. As the evidence hardened, govern- :: tT'inent agencies have drastically ^ t.: changed legislati.o regarding vinyl V-. chloride. Some of the pressure for // changes steamed from the alarzniog -v `"v .r" *' *. ,'i ' .Tresulta.of Internal research programs.-. ' iMore' jn the form of petitions, dozens j" of rphone calls and'disclosure actions ; came from the feisty goading of a. `...uses them. '> ,'y Halph Nader-funded Health Research //. 'Other agencies engaged inactive re* ; -/Group (HRG). ' * '/ ,/. search are the Natinal Institute for l/ . Environmental Health, the. Environ-; '/.'mental Protection Agency;, the Na-f tional Cancer Institute, Environmental -; Protection'Administration for the City/ of New York and the Center for Dis- _. ease Control, Atlanta. " 7.., The investigations, are far from com. - plete, blit under the gun of a continue : ing health hazard of uncertain propor tions, scientists will discuss their in- ; ,terim findings at an international con- reference May 10 organized by .the New York Academy of Sciences. v. That link is now just, about as cer- v'7- In mid-January, B.F. Goodrich an- ./nounced the death of three long-term ' u employees at the Louisville polyvlnyi 7 chloride plant with the significant ad- ' r decdum that the company was investi- h.gating whether the ,deaths^"were re-, lated to occupational causes.' Since then,1 94 consumer products' ' .containing vinyl chloride-have been ei- : ` Iher voluntarily withdrawn by inanu` facturers or banned from sale by the EPA and FDA. These included 41 aero sol pesticides for household use, 26 '' tain as the relationship between the tu7 bercle bacillus and the etiology of tu- home and professional hairsprays, 13 deodorants and anti-perspirants. ' bcrculosis, according fo Sellikoff-. "I :* don't think there's any doubt of a firm, '. strong association between angiosar- ' The radical change in attitude to ward the colorless gas is reflected in Department of Labor regulations on *coma and vinyl chloride exposure," he ''said. y the exposure of industrial workers. Previous regulations limiting workers Problems Found to 500 parts per million were based on avoiding combustible concentrations ** HERE expect' reports from American and European sci- and toxic levels sufficient to cause diz ziness and nausea. A- new emergency enlist to further substantiate the link 1- between vinyl chloride and "angiosar- - coma and to predict a potential death L exposed workers. standard limiting exposure to 50 parts per million is now in force and the Occupational and Safety Health Ad ministration (OSHA) plans to seek a permanent standard of no measurable^ 'level.' ' ' ' * l- 9 *^1 0 0 3 0 ^0 d ia l Though tfrofr studies o incomplete, ' the researchera are sure enough about vinyl* chlorid- 'to express a uniform constematioi the idea of workers being exposed to levels as relatively low as 50 ppm. "I don't think it's adequate," said Selikolf: "It would be foolhardy to say'this lower level is safe. If cancer occurs at higher levels, it will occur at % lower. levels, though less frequently." . In mid-February, Italian scientist1 Prof. Cesare Maltoni told a hurriedly* .assembled OSH/ aring that two out of 67 rats subject ,, to daily dosages ot vinyl chloride"'developed angiosarcomas!.^ , At a very high level .of 6,000 parts per' .- minion, ll.oufof'72 rats developed the rare tumors.-"-However, the bombs' . in Mallom's findings that ledito an uq< mediate emergency revision of the in-, (`It's Heartbreaking!' THE PERCEPTION of vinyl chloride ' as dangerous in any amount leads dustrial 'atmospheric levels 'then stand-1 t ing at 500 ppm was'the'statement tha(| some ratsj developed . the. .tumors>aij .250 ppmy <4*2? to a depressing comparison with the lev'`-Feb. 14,. EPA forms a task, force^ els accepted as reasonable by the cheml cal industry as late as January this year. under'Glenn Schweitzer .to assess over-all health and environmental "risks asH Vinyl chloride readings declared by the companies themselves ranged in ordi- sociated with-vinyl'chloride! and PVCM! On April 10,. ho directs EPA's 10 re^j - nary`production from 20-100 ppm. But . gional offices to'test the water, air an<Q occasional very high readings were ad'/roitted. The plastics division of Uni- royal at Painesville, Ohio, for Instance, solid waste emissions from at least ont^ plant losing vinyl chloride to make PVC/j Feb. 21, .the ^HRG petitioned th^j told NIOSH researchers that workers . FDA to ban and name cosmetics employ^; scaling the vessels in which PVC is ing vinyl/ chloride as a propellant onv 1 April 19, EPA administrator Rus sell Train.hears the result of some cru-j cial experimentation by his own peol pie. Under lest, pesticides on public^ sale raised the vinyl chloride concen tration in a small room such as a bath room to 400 ppm in a 30 second burst. Without light or ventilation, the re searchers reported to their chief, the concentration of gas diminished by1 only 1 per cent in a four-day period. t . April 24, Citing those tests and the !, easy availability of substitute gases, . Train signs an order.'banning all vinyl ; chloride products for indoor uses. The EPA administrator was doubtless also aware of some preliminary findings in. a long-term study by the Manufacture ,'ing Chemists 'Association which' dis- . closed tumors in mice at levels of only 50 ppm. The names of seven of the vi nyl chloride products regulated by the / EPA still have not been released. .. Gloomy Prediction -' made were brier.; exposed to levels as the basis of "well-documented carcino-^ />/*|lHE POSSIBLE significance.:of the 'high as 1,600 ppm. When told that, Seli- genicity." A similar petition went to}' X 12 deaths' currently associated koff exclaimed, "It's heartbreaking!" EPA Administrator Russell Train, call-; with vinyl chloride-induced angiosar- With responsibility for governing vinyl ing for suspension of vinyl chloride prod M coma for the 6,500 work force drew a chloride use falling between the over ucts regulated by the EPA. '? ''gloomy prognostication from Dr. lapping jurisdictions of several federal1 March 23. Responding to the HRG c. agencies -- all adjusting at differing . petition on pesticides, the EPA states Selikoff: "Twelve deaths may cot "sound many, but put it in this pcrspec- . speeds 1 new knowledge on the gas -- \ some important gap. still exist. Vinyl chloride production is estimated at 7 billion pounds a year and it is still . being tr\ii?portcd by rail and highway they have no listing of products contain ing vinyl chloride and are sending a. warning letter to all 35,000 pesticide manufacturers suggesting- the substitu,'tion of another gas.-1 ' "' '""Mi 1-tive. In the early 1950s there were ! maybe 1,000 workers in PVC plants. In ,the normal course of events something > like 100-150 would have died. Twelve ;r' deaths out of 100-150 suggests a rate of ' under t!;.:,gerously outdated hazard rules. March 26, The Health Research q 12 per cent." On April 14 a freight train derailed and dumped a tank car of vinyl chloride on Group -- unsuccessful in persuading Clairol to withdraw vinyl chloride-pow' **' Selikoff's study of Goodyear's vinyl i' chloride operation included a trace on a Philadelphia expressway. Dr. Wag oner broke from his work in Cincinnati to place telephone calls to the Pennsyl- ' ered hairsprays from tho market--takes the dispute to the FDA in a letter to the administrator Dr. Alexander N. Schmidt. 68 t'.er cent of all employes with five or m- years service. To the'company's di very of one angiosarcoma death, vania Poison Center and{the Penn Cen-*' The substance of;the HRG** case was Selikoffs workers added the names of tral Railway. ! Neither knew they were dealing with a proven cancer-causing ; ` Clairol's'- admission'" that -users of 'the; sprays were exposed to'200 ppm for a/ ; two ethers whose causes of death were misdiagnosed on death certificates. Re- _ agent. In the past three years, eight spillage incidents have been reported. one-minute duration. The HRG .director, Dr.' Sidney -Mi Wolfe,'reproved the : searchers interviewed family doctors - and hospital pathology' departments . The Health Research feroup, partially_ FDA:: "Whereas'this-inaction by the and studied original pathology slides s, responsible for persuading the EPA to' ban sales of inside! insecticides, is now.: pushing the agency'to seize all outdoor;, vinyl chloride aerosols with the logical ' argument that <-n present knowledge, any further consumer, .exposure is in-i tollable. --i r~\ r;; .If] Emergency Revision - r. "5'j p FDA must be welcome and financially to verify the true cause of death as'an- beneficial to Bristol-Myers and : its Clairol subsidiary, it may be fatal for many unsuspecting citizens of this giosarcomaMisdiagnosis owing to tbo rarity of the particular strain of cancer ii also country." April 3. The FDA announces action to end the use of'vinyl chloride in: 'troubling ' Wagoner's ' NIOSH products under its control. The order . .researchers: "Out of the 12 deaths so concerns' three' manufacturers andj[ s far confirmed,'33 Per cent were misabout 50 products. Calling the hazard! . diacnosed. One was classified as cir- THE RECENT history, of vinyl chlor--i' ide shows a fascinating helter-skel-|; ter pattern of scientific, initiative and;., governmental response as society staged^ s hurried retreat from a chcmical're*;? . garded as relatively benign &ince it was*-2 to hair-spray users `'extremely re-.M rhosts and another as a benign liver tu- mote," Clairol Inc. nevertheless an-* ''mor." (The National Cancer Institute nounces the recall of 100,000 cans of- uhas taken the unprecedented action of Summer Blonde and Miss Clairol aero b opening a national registry of ail an- sol hair sprays. rgiosarcoma cases.), ; April 5, In response to a March 11 .{ Though Wagoner's primary concern fir^t manufactured in 1939. ' * recommendation from NIOSH that the .is with the safety of industrial work- ; Jan. 2C, Dr..Joseph A, Wagoner rfl-.j rector of NIOSH's field investigation^ division begins, with "a sense of national urgency," an epidemiological study ofx Mur long-established PVC manufacturer g plants. At this time the research is', going full-force, occupying 18 out of 32V people on his staff. One branch has shut? down work on every other project ten handle the vinyl chloride .emergency./.'; acceptable industrial level should be f ers. the throe questions he is trying to zero, the Department of Labor an ^answer encompass far broader ramifi nounces an Interim emergency level of cations. > [' v ' ' 50 ppm. Ap-ril 17/ The EPA identifies. . 20 ' ``We want'to assess the magnitude of the risk -- how many other cases are products containing vinyl chloride, 1 . thcie? And secondly, whether other or- lcavcs 21 more unnamed pending man- l gans of the body afe affect(.d b vinv| ufacturers* approval of their pubhea-1, cbloride j wou]d SUsepct we ,hould be tion. /looking at the lung aa a target organ." Wagoner's third area, of Jnvestiga- jjNtlon is the potential vulnerability of. Mother indur l workers, and finally, :the consume. "We want to know how ' X widespread exposure to vinyl chloride . 'vis in the making of PVC and in the va- * t^riety ot -uses of PVC." y` Casting .the Net Wide SO' FAR,' Wagoner's "walk-through" , >.;i survey teams of doctors, engineers, biostatisticians and epidemiologists have ,*; studied arid microfilmed personnel rec-``, ords at 'four plants', -They have' exam ined conditions under which vinyl chlor- iijde-'has been used and ,the\ likely ex posure, by leakage of the workers. S'/rBut `-theprirae^,objective is a : com- i prehensive 'study of mortality, among , workers at the plants. From a'Search of the microfilmed`personnel records, the-NIOSHiresearchers are establishing fhow many of the plants' past and pres- ir 'ent employees;are dead,.and what'they J'died'from.; The net is cast wide to exSy'amine' all {fatalities, because the Good- ft- rich' Company's'-owri screening program SU*t the Louisville plant, disclosed 20 cases . ->of . liver abnormalities' in addition to previously i undiagnosed angiosarcoma in. jf^two work ts. ___ i';j* ' From the autopsies of former workers Ji'who died in non-related accidents, the t! .'research c.-s hope to understand the range Vi of `conditions''vinyl - chloride may pro- V 4nce other than . liver malignancy. ` V;,V Cooperation iby: all peripherally in- evolved in the NIOSH study has been .^excellent. Wagoner says. The OhioState Si motor vehicle registry which is able to provide an initial check on whether for- Amer employesof an Ohio plant are alive '.:lus cut' the response time from three ^.months to three hours,'and police scout cart have been .offered to ferry.ma- ^terials. v.. , '`-iThei pressure is constant. "Everyone -' wants results," says. Wagoner. "We are jitlooking ` foVdong-term:.carcinogenic re* l^sul^s, but at the moment we have more Questions, than ,answers.!'^. ; *.-{ .. ' v<"*'- , ,,v . 'j When .properly.'f.cured and aged, `.finished PVC ' is- thought {po.; to exude vinyl chloride fumes. This belief is being tested by' NIOSH in experi ments Involving the placing of PVC pel lets in closed chambers and measure ment with sensitive devices. The extent of consumer hazard will depend on the as yet unknown frequency with which vinyl chloride "leaches" out of a, host .. of everyday products. ` ' `V fl NIOSH is now placing a contract for -the full . investigation of "leaching." Wagoner will say only, "We don't knov what the full spectrum of disease i. ''but there are concerns for th<? consurr er." At the National Cancer InstJtr where another major vinyl clor: ie search program is under way, ...id an -' angiosarcoma ; patient is undergoing chemotherapy and study Dr. Umberto . _ Saffiqtti .associate director of carcono- , genesis, considers the gas "a major potential hazard," and "a serious problem for consumers." , " ' While the exposure of an individual consumer J$ lower than a vinyl chloride worker, an infinitely greater number of people are involved, he points* out: "There may be millions of people In volved and an incidence at a much lower rate in a large population may still be a substantial number of cancer cases." -' i'HRG director Wolfe' sees the 'known angiosarcoma deaths as the start; of a series of cases and the best reason for -reducing consumer;.exposure tor.vinyl - chloride immediately, . "We are now seeing people who got really high doses. In the next few years we may see beauticians exposed to dosea pot quite so high through .hair-.sprajj . A-very few years later we may see cf| turners who just happened to be hea^ .aerosol users." . \* h <S3 <sa <se S3 CONOCO PC OK ^ May MAY 2* 19 74 1 1 809 AM K. KENNEDY PONCA REGARDING wAYNE SORENSON'S DRAFT LETTER TO MCCOVIN OF FDA SENT TO KLS. I WOULD LIKE TO DISCUSS IT WITH YOU BEFORE WE SEND ANYTHING. THE ANALYTICAL PROCEDURES SECTION SEEMS COMPLETE AND WELL ORGANIZED BUT THE INITIAL DATA WE HAVE GENERATED APPEARS TO BE RANDOM AND INCOMPLETE IN EXPERIMENT SCOPE AND ASSOCIATED DATA ON TEST CONDITIONS- IS THIS INITIAL DATA OF SUFFICIENT SCIENTIFIC QUALITY TO REPORT TO OUR MANAGEMENT OR THE FDA. WHEN WILL MORE COMPLETE RESULTS BE AVAILABLE OF THE TYPE WE ARE SEEKING. GIVE ME A CALL. J. J. LANGFORD AF E ND fo 47 CHEMICALS RESEARCH MAY 2 TiT" WP?' OHK AJLu WPIM 1974 T vrd 0 0 0 2 0 0 m l ISSLBB ct* CONOCOPCM SARK m MAY-1 -m r.49 WU PAT B PAB134(U26M1-011362C121006>PD TWX PANTASOTE NJ 00008 PASSAIC# N.J MAY 1# 1974 PMS ROBERT W. GERWIG CONOCO PARK EIGHTY PLAEA EAST SADDLE BROOK# N* J* 05/01/74 1117 ` SMITH OF ROBINTECH AND I HAVE BEEN CHARGED BY OSHA SUBCOMMITTE# VCM/PVC AD HOC COMMITTEE OF SPIT WITH PREPARATION OF POSITION PAPER ON THE EFFECT OF ANY PROPOSED PERMANENT VCM EXPOSURE STANDARD ON PVC PROCESSORS TO COMPLETE THIS TASK WITHIN TWO WEEKS# WE URGENTLY REQUIRE THE RESULTS OF ANY VCM LEVEL MEASUREMENTS IN PROCESSING PLANTS# DESCRIBING LOCATIONS WHERE MEASUREMENTS TAKEN AND METHODOLOGY EMPLOYED* PLEASE FORWARD TO ME ANY AVAILABLE DATA AS SOON AS POSSIBLE. JACK JAGLOM THE PANTASOTE CO* OF N.Y.# INC* 26 JEFFERSON ST* PASSAIC# N. J. 07055 J TELEPHONES 201-777-8500 TWX: 710-989-7108 NNNN CHEMICALS RESEARCH MAY 7 1974 U* CONOCOPCM SARK LENNOXCR COL M i VRD 0002001554 wioriL fJSSOi .iAFION JPOOD IflHAINS 1725 Eye Street Northwest Washirtgton, D. C. 20006 Telephone: (202) 331-7822 April 29, 1974 V Mr. Jerome Heckman Keller and Heckman 1150 17th Street, N.W. Washington, D. C. 20036 Dear Jerry: To date we have met with Dr. Virgil 0. Wodicka (Director, Bureau of Foods, FDA), Richard J. Ronk (Director, Division of Food and Color Additives, FDA), and Richard E. Feltner (Assistant Secretary for Marketing and Consumer Services, USDA) regarding the impact that a disruption of the supply of PVC might have on the food industry. It would be most helpful for us if you could ask one of SPI's experts to compile a list for us of all the uses of VC or PVC that might be found in a supermarket. We are contemplating having a number of meetings with government officials in the near future and a prompt response would be appreciated. Best wishes. Sincerely PAKiblm Paul A. Korody, Jr. Director of Governmental Affairs 6i f i 00Z000*fltA NOTICES 14753 interim 2.0 grams per mile NO, stand ard established by the July 30, 1973, de cision. On December 28, 1973, the Adminis trator announced receipt of several ad ditional requests for suspension of the 1976 KOi standard, and delineated pro cedures for disposition of those appli cations and all other applications for suspension filed with the Administrator prior to January 4, 1974 (see 38 FR 35528). Then on February 1, 1974 (see 39 FR 4132), the Administrator granted suspension of the 1976 NO, emission standard to sixteen (16) additional man ufacturers. On March 25. 1974. the Administrator announced receipt of two additional re quests for suspension of the 1976 NO, standard (Automobiles Peugeot and Isuzu Motors), and delineated proced ures for disposition of those applications and all other applications for suspension filed with the Administrator prior to April 5, 1974 (see 39 FR 11133). Sub sequent applications for suspension have been fi)ed by Checker Motors Corpora tion (received March 1. 1974), Mitsu bishi Motors Corporation (received April 1, 1974), Toyo Kogyo Company, Limited (received April 3. 1974), SS Automobiles Incorporated (received April 5, 1974), Toyota Motor Company. Limited (re ceived April 5, 1974), and Avantl Motor Corporation (received April 5,1974). In accordance with the procedures out lined in the March 25, 1974, Federal Register notice, each application was made available for public review and comment. Since no public comments were received on the submitted applications, I have determined that no useful pur pose would be served by holding a sus pension hearing on these applications. On the basis of our review of the sub mitted applications, I have .determined that each applicant has made all good faith efforts to meet the 1976 NO, statutory standard. Accordingly, I here by grant suspension of the 1976 NO* standard to each of the eight (8) ap plicants set forth above. Each applicant's 1976 model year light duty vehicles sold In the United States will be required to meet the Interim NO* standard of 2.0 grams per mile. Dated: April 19,1974. John Quarles, Acting Administrator. [FR Doc.74-9614 Filed 4-25-74.8:45 ami TECHNICAL ADVISORY GROUP TO THE MUNICIPAL CONSTRUCTON DIVISION Notice of Meeting Pursuant to Public Law 92-463, notice Is hereby given that a meeting of the Technical Advisory Group to the Munic ipal Construction Division will be held at 9 a.m. on May 13 and 14, 1974. at the Dallas Regional Office, 1600 Patterson Street, Dallas, Texas. The purpose of the meeting is to re view and discuss the following subject matter: Section 937 and Value Analysis, Non-restricuve specifications, reactions to current title II regulations. Best Prac ticable Treatment Technology, Design/ Construct, and section 208 regulations. The meeting will be open to the public. Any member of the public wishing to attend should contact the Executive Sec retary, Mr. Harold P. Cahill. Jr., Director, Municipal Construction Division, Envi ronmental Protection Agency. Washing ton. D.C. 20460. The telephone number is area code 202-426-8986. Roger Strelow, Acting Assistant Administrator for Air and Water Programs. April 19,1974. [FR Doc.74-95il Filed 4-25-74;8:45 ami VINYL CHLORIDE Emergency Suspension Order Concerning Registrations for Certain Products and Intent to Cancel Registrations Notice is hereby given of the emergency suspension of, and notice of intent to cancel the registrations, under the Fed eral Insecticide, Fungicide, and Rodenticide Act, as amended ("FIFRA"; 7 U.S.C. 135 et seq., 7 U.S.C. 136 et seq.), of all pesticide spray products containing vinyl chloride, whether as an active or inert ingredient, for uses in the home, food handling establishments, hospitals or In enclosed areas. Concurrent with this notice of suspension and notice of intent to cancel, the Environmental Protection Agency, is requesting that all existent stock of such products be recalled by the manufacturers. Findings or Fact 1. In January 1974, it was reported that four workers who had had intimate occupational contact with vinyl chloride had died from, angiosarcoma of the liver. 2. Angiosarcoma of the liver is an ex tremely rare form of cancer. Data from the Third National Cancer Survey, con ducted by the National Cancer Institute over the three-year period, 1969 to 1971, indicates that the number of cases of angiosarcoma of the liver expected in any one year could range-from 11 to 53 for the total United States population. 3. On February 15, 1974, an Italian scientist. Professor Cesare Maltoni of the Bologna Institute of Oncology, re ported on an experiment in which rats exposed to vinyl chloride gas for four hours per day, five days per week, for 127 weeks developed angiosarcoma of the liver. These cancers were found at an in creasing frequency at several dosages, beginning at 250 ppm and above, but not at 50 ppm, the lowest dosage tested. 4. Since .the first occupational reports this year, several more cases of angiosar coma of the liver have been confirmed, bringing the total number of these can cers among occupationally exposed work ers in the United States to twelve. Two additional deaths from angiosarcoma have been reported among occupationally exposed workers outside of the United States. Tire evidence relating vinyl chlo- ride exposure and these deaths is ci\. cumstantial. but strongly suggestive of a causal relationship, especially when com bined with animal data. 5. In 1973, the Manufacturing Chem ists Association contracted with Indus trial Bio-Test Laboratories, Inc. of Northbrook, Illinois, to conduct labora tory studies exposing mice and ham sters as well as rats to vinyl chloride gas. While this experiment is not yet com pleted, there have been a high number of deaths among the test animals, controls as well as exposed. In the course of exam ining these animals to determine the cause of death, a significant number of the dead mice in the exposed group showed tumors of various sorts. Two cases of angiosarcoma of the liver were observed in mice exposed to 50 ppm vinyl chloride in the air, four cases of the rare cancer In mice exposed to 200 ppm, and in seventeen of those exposed to 2.500 ppm. No angiosarcomas have been found in the rats or hamsters that have died during the course of the experiment. The significance of these figures is still not fully understood because data on the deaths in the control group of mice has not yet been fully analyzed. Nevertheless, the observation of a dosage-related pat tern of occurrence of this rare form of cancer, coupled with the previous results in Italy, provides strong evidence that exposure to vinyl chloride can cause liver cancer. 6. Seventeen manufacturers have reg istered pesticidal aerosols in which vinyl chloride was one of the inert ingredients, and thus unlisted on the label. These manufacturers plus their distributors ac count for 41 different brand name prod ucts. Vinyl chloride is used as a propel lant component in such aerosols. 7. Although all of these mnufacturers state that they have stopped using vinyl chloride as a propellant, some as early as May 1973, there are at least an esti mated 19,000 cans of such products in commercial channels. 8. Last Friday, I learned of prelimi nary testing and calculations done 1 EPA involving the use of an aerosol con taining vinyl chloride showing that a 30 second release of the aerosol could result in a concentration as high as 400 ppm in the air. In a separate test, preliminary results showed that after as long as four days, only about 1% of the vinyl chlo ride gas would dissipate under conditions where the exposure area was not venti lated and little, if any, light was present. Calculations based on this information, assuming three changes of air per hour in an enclosed area, and experiments by EPA scientists measuring vinyl chloride levels following spraying in the home would indicate that a detectable concen tration of vinyl chloride could still per sist for several hours after spraying. 9. Exposure to vinyl chloride has been associated with a significant number of cases of a rare liver cancer in experi mental rats and mice, and in humans. Although vinyl chloride is apparently no FEDERAL REGISTER, VOL 39, NO. B2--FRIDAY, APRIL 26, 1974 VRD 0002007560 4.4754 3TICES longer being used as a propellant in pes ticides, some stocks remain on the mar ket. The use of these pesticides in an en closed space, even in short bursts (e.g,, 30 the product pending the outcome of either cancellation proceedings or any hearing pursuant to section 6(c) (2) of F1FRA. the Federal Register (April 26, 1974), which ever occurs later, unless the regis trant makes the necessary corrections to its registration. These pesticide products seconds), could result in exposure levels similar to those which have produced angiosarcomas In test animals. The health implications for humans at these levels for short exposure periods are un determined, but it is prudent to asrume Present information indicates that most, if not all manufacturers of pesti cides containing vinyl chlorides as a pro pellant. are willing to utilize substitute substances for this purpose. The En vironmental Protection Agency has containing vinyl chloride may not be legally shipped in interstate commerce. Dated: April 24.1974. 'Russell E. Train. Administrator. that any exposure, at these levels will already received several applications for Ikboob Aerosol Pesticides Affectb> by have increased the risk of cancer should amended registrations to eliminate vinyl Today's Suspension the strongly suspected causal relation chloride as an ingredient. It is my under Product Company ship between vinyl chloride and cancer standing that similar amendment appli Brulln Bug Bomb____ Brultn ft Co. be finally confirmed. cations will be forthcoming from other Paroclde with Sevln.. Carson Chemicals. 10. The benefits of the use of vinyl chloride as a propellant are very small because several suitable substitutes exist which. In fact, are frequently used. Al though the number of pesticide products containing vinyl chloride presently in commercial channels or in use is not thought to be substantial, the risk of continuing such use in the face of acceptable substitutes is unjustified. 11. Attached to this order are the names of the pesticide products contain ing viM'i chloride which are known by manufacturers. Thus, there is no indi cation that elimination of use of these products pending completion of suspen sion and cancellation proceedings will have any effects upon availability of the associated aerosol pesticides. Indeed, in the course of investigating use of these products prior to this order, instances were discovered of previous voluntary discontinuance of the use of vinyl chlo ride as a propellant (without amended registrations having been submitted or issued). Demert Raw Roach, Ant and Wasp Killer. Cobra International Roach. Ant and Wasp KUler. Rexall Ant and Reach KUler. Walgreen Ant ft Roach ICUler. Flea Killer for Dogs and Cats. Barcolene Spray Dlslnfectant. Coop Dairy Insecticide Inc. Demert ft Daugherty, Cobra International - [Dj. Rexall Drug Co. [D]. Walgreen Laboratories, Inc. |D[. Chase Products Co. The Baroolene Co. Farmland Indus- this Agency to be registered for uses in Although voluntary discontinuance of for MUX Houses And tries, Inc. the home, food handling establishments, the use of the substance is a commenda hospitals or in enclosed areas. There ble development, significant quantities of may be others. pesticide products containing vinyl chlo Conclusions ride have previously been distributed and are now in retail outlets or in actual use. Section 6(c) of FEFRA provides for In addition, although the Environmental the suspension of a registration of a pes Protection Agency desires, whenever pos ticide if the Administrator determines sible, to secure voluntary compliance that action is necessary to prevent an rather than proceeding by order, the imminent hazard during the time re time required to insure that such compli quired for cancellation proceedings un ance has actually taken place would der section 6. Section 6(c> also provides necessarily delay achieving the most for issuance of an emergency order of rapid possible nationwide cessation of suspension by the Administrator in the the sale of products containing vinyl event he finds that an emergency exists - chloride, and the recall of existing stocks. that does not permit the holding of an Therefore. I have concluded that in view expedited hearing on the question of sus of the substantial risk from continued pension before issuing an order. The use of vinyl chloride, and the absence of statute also provides a general definition any significant benefit from its con of the term "imminent hazard" in sec tinued use pending completion of can tion 2(1) which states that "imminent cellation proceedings pursuant to section hazard" means a situation which exists 6, an imminent hazard does exist under when the continued use of a pesticide the terms of section 6(c) of FIFRA and during the time required for cancellation an emergency does exist which does not would be likely.to result in unreasonable permit delay of suspension pending a adverse effects on the environment. A possible hearing pursuant to section determination of unreasonable adverse 6(c) (2) prior to issuance of an order of effects oh the environment must con suspension, Indeed. I find that as a result sider the degree of risk to man or the of the above findings of fact, particularly ' environment, taking into account the the recent results of Agency testing, that economic, social, and environmental immediate action is required. ' costs and benefits of the use of any pesti cide (Section 2(bb>). Emergency Suspension Order and Notice The evidence available at this time of Intent to Cancel indicates the presence of a clear risk to In accordance with the attached find Animals. Excelcide 16-oz. Aero- sol Bomb. Navy Brand Thrifty 50 Mothrid Moth Proofcr Mothrid Moth Prooler The Huge Co. Navy Brand Mfg. Co. ID]. Hysan Corp. Liberty Products Co. Cedar scented or Activated Moth Proof Spray Cedarized. Nokout 25 Aerosol Insectlclde. Strike--Wasp and Hornet. Nokout 35 Insecticide. Spritz Metered Air Sanitizer. Anchor Flea, Lice and Tick Bomb. (DJ. Hysan Corp. Albert Woods Wholesale (DJ. Hysan Corp. Hysan Corp. Phllips-Roxane, Inc, F-L-T Bomb........ Blo-Ceutlc Laboratories |D]. WAYNE, Flea. Lice and "Allied Mills, Inc. Tick. [D], Rodgers' Insecticide Jay Rodgers Co. and Repellent. Total Release Insect Spray-Chem Corp. Fogger. Crown "Total'' Com- plete Release Insect Fogger. Crown Chemicals, Inc. [D] Roberts' "Total" Com- Roberts Laboratoplete Release Insect ties JDJ Fogger. Chaperone Flea ft Tick Sudbury Laboratory Killer. Pyrethrin ` Insecticide Woodbury Chemical Pressurized Dairy Co. human health from continued exposure ings and conclusions, it is hereby ordered Insecticide. to vinyl chloride. Indeed, this chemical that the registrations for all pesticide COOP Pyrethrin In- Farmland Indus- presents a most unusual case because the products containing vinyl chloride, sectlclde Pressurized tries, Inc. (DJ rare form of cancer found in occupa whether as an active or inert ingredient, Dairy Insecticide. tional workers can be readily demon be suspended immediately for all uses Mld-Am Brand Pyre- Mid-Amnrican strated in test animals. Thus we are in the home, food handling establish- thrln Insecticide Dairymen. Inc. faced with a substantial risk to human ments, hospitals, or in enclosed areas. I Pressurized Dairy [D] health upon continued exposure to vinyl also serve notice of my intent to cancel chloride. The existence of this risk would such registration within 30 days from require a compelling demonstration of the receipt of this notice by the regis Insecticide, ' (Dj--Distributor of Product Listed Above benefits to justify the continued use of trant. or publication of this order in (FR Doc.74-9719 Plied 4-25-74;8;45 am] </* FEDERAL REGISTER, VOL. 39. NO. 92--FRIDAY, APRIL 26, 1974 1551001000 All A 14522 PROP' 'ED RULES i DEPARTMENT OF LADOR Occupational Safety and Health Administration [ 29 CFR Part 1999 ] STANDARD FOR OCCUPATIONAL EXPOSURE TO VINYL CHLORIDE Notice of Intent To Prepare an Environmental Impact Statement The National Environmental Policy Act of 1969 <42 U.S.C. section 102) re quires each Federal agency to consider the environmental effects of proposed ac tions and to prepare environmental im pact statements on major actions affect ing the quality of the human environ ment. Accordingly, the Occupational Safety and Health Administration, U.S. Department of Labor, in conformance with its procedures for environmental impact statements (29 CFR Part 1999), announces its intention to prepare an environmental statement assessing the impact of a proposed standard for occu pational exposure to vinyl chloride to be published in the Federal Register in the near future. The Office of Standards Development, Occupational Safety and Health Admin istration, is currently collecting infor mation and data on possible environ mental impacts of the proposed stand ard, such as any adverse environmental effects which cannot be avoided should the standard be adopted; alternatives to such a standard; the relationship be tween local short-term uses of man's en vironment and the maintenance and en hancement of long-term productivity; and any irreversible commitments of re sources which would be involved if the standard be implemented. Those issues of particular interest are: a. Any medical or toxicological evi dence which indicates that exposure to vinyl chloride or its polymers produces adverse effects to living organisms, es pecially primates. b. Current and historical levels of oc cupational exposure. c. Combustible characteristics asso ciated with vinyl chloride or its polymers, especially information correlating acci dent experience; damage to facilities, in terruption of plant activities, and/or storage and shipment difficulties. d. Identification of the uses of vinyl chloride or its polymers, through finished products, and determination of the quan tity of use. e. Any information suggesting substi tutes for vinyl chloride or its polymers, to include estimates of the extent to which substitution is feasible. f. Any suggested actions which will control the health hazards associated with produ lion, storage, or shipment of vinyl chloride or its polymers through finished products. g. Any other pertinent information. Any person having information or data on this subject which is not readily avail able in the open literature is invited to submit It, with accompanying documen tation, to the Director, Office of stand ards Development, Occupational Safety and Health Administration, 1726 M Street, NW, Room 500, Washington. D.C. 20210 by May 17. 1974. All information received will be available for public In spection at the Office of Standards Development. When the draft environmental impact statement on vinyl chloride is completed, copies will be available to any member of the public who requests it. A 45-day period will be allowed for the public to submit their comments. Signed at Washington, D.C., this 18th day of April 1974. John Stender, Assistant Secretary of Labor. |FR Doc.74-9300 Filed 4-23-74:8:45 am] Wage and Hour Division 129 CFR Part 511] WAFE ORDER PROCEDURE FOR PUERTO RICO. THE VIRGIN ISLANDS, ANO AMERICAN SAMOA Changes in Procedures as the Result of the Fair Labor Amendments of 1974 Under authority provided in the Fair Labor Standards Act of 1938 <52 Slat. 1062, 1064, as amended; 29 U.S.C. 205, 206, 208) and Rtorganlzation Plan No. 6 Of 1950 <3 CFR 1949-53 Comp., p, 1004) and Secretary's Orders Nos. 13-71 and 15-71 (39 FR 8755 and 8756), it is hereby proposed to revise 29 CFR Part 511 to adapt the procedures set forth therein to the Fair Labor Standards Amend ments Of 1974, Pub. L. No. 93-259. The proposed revisions of f 511,10 and 511.13 would prescribe the greater re sponsibility of the employers or of the industry in establishing its inability to pay the rates comparable to the ones in the various States. The amendment to $ 511.8 would show the current title of the Director of the Caribbean Office. Interested persons may submit writ ten data, views, and arguments concern ing the proposed revision on or before May 9, 1974. Such submissions may be filed with the Administrator, Wage and Hour Division, U.S. Department of Labor, 14th Street and Constitution Avenue, NW, Washington, D.C. 20210. 1. As amended paragraph (b) of 511.8 would read as follows: 311.8 Prehearing statements* # (b) Any interested person who wishes to participate on his own behalf or by counsel shall file a written prehearing statement. Not later than ten days be fore the first hearing date set for any committee in a notice of hearing con cerning minimum wages for Puerto Rico or the Virgin Islands, or such other pe riod of time as may be prescribed in a notice of hearing, or other notice pub lished in the Federal Register, the original and 11 copies of the prehear ing statement shall be filed at the Office of the Director of the Caribbean Office of the Wage and Hour Division, United States Department of Labor, 7th Floor, Condominio San Alberto Building, 1200 Ponce de Leon Avenue, Santurce, Puerto Rico, and one copy at the Office of the Administrator of the Wage and Hour Division. United States Department of Labor, Washington, D.C. 20210. If such statements are sent by air mail from Puerto Rico or the Virgin Islands to the mainland, or from the mainland to Washington, such filing shall be deemed timely if postmarked within the time provided. The number of copies of such statements and the time and places for filing them will be specified in notices of hearings to determine minimum wages for American Samoa. The prehearing statement shall describe the person's in terest in the proceeding and shall con tain (1) the prepared statement he pro poses to give, if any; (2) a statement of the Individual classifications and mini mum wage rates, if any, he proposes to support; (3) the written data he pro poses to introduce in evidence, includ ing all tangible objective data to be sub mitted pursuant to i 511.13; (4) the names and addresses of the witnesses he proposes to call and a summary of the evidence he proposes to develop; (5) the name and address of the individual who will present his case; and (6) a state ment of the approximate length of time his case will take. If the prehearing state ment is in conformity with the above requirements, the person shall have the right to participate as a party. In ac cordance with section 6(c) of the Ad ministrative Procedure Act, industry committee shall, after considering the advice of committee counsel, issue sub poenas authorized by section 9 of the Fair Labor Standards Act of 1938, to parties who make a request therefor ac companied by a clear showing of general relevance and reasonable scope of the evidence sought. 2. As revised, 511.10 would read as follows: 511.10 Subjects and issues. (a) The declared policy of the Act with respect to industries or enterprises in Puerto Rico, the Virgin Islands, and American Samoa engaged in commerce or in the production of goods for com merce is to reach as rapidly as is econom ically feasible without substantially cur tailing employment the object of the minimum wage rate which would apply in each such industry under paragraph (1) or (5) of section 6(a) but for sec tion 6(c). Each industry committee shall recommend to the Administrator the highest minimum wage rates for the in dustry which it determines, having due regard to economic and competitive con ditions. will not substantially curtail em ployment in the industry and will not give any industry in Puerto Rico, the Virgin Islands, or American Samoa a competi tive advantage over any industry in the United States outside of Puerto Rico, the Virgin Islands and American Samoa; ex cept that the committee shall recom mend to the Secretary the minimum wage rate prescribed in section 6(a) or 6(b). > KDERAl REGISTER, VOL 34, NO. 80--WEDNESDAY, APRIL 24, 1474 00020^7573 50 C3 V. R. Sorenson will compile data re residual VGM In WC pipe and extractability of said VCM. The analytical method* will be written by 4/29/74. WRS will facsimile you a copy of the cover letter with conclusions either 4/29 or 4/30 and will release information only after approval by RWG, JJL & KLS. Heckman, KLS & WRS will get copies of the mailing to McCowin of FDA. Flynt Kennedy Jms Qua. Res. Div. - R&D Charge: 8924-10-27 VRD 000 20 0 7583 MANUFACTURING CHEMISTS ASSOCIATION 1625 CONNECTICUT AVENUE, N. W. WASHINGTON. D. C. 20009 FOR RELEASE For Immediate Release CONTACT : Richard F. Blewitt (202) 483-6126, ext. 282 WASHINGTON, D. C., April 16 -- The Manufacturing Chemists Association (MCA) announced today preliminary indications that vinyl chloride exposure has produced angiosarcoma -- a liver cancer -- in mice at several exposure levels. Industrial Bio-Test Laboratories, Inc., who are conducting the MCA-administcred vinyl chloride animal exposure study, informed MCA that their work -- although very preliminary at this point tends to confirm the findings of Professor Cesare Maltoni, an Italian scientist who found that vinyl chloride exposure in rats caused cancer. MCA immediately notified the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health and the Environmental Protection Agency of the preliminary test results. In the MCA-administered study, rats, hamsters and mice are being exposed seven hours a day, five days a week, to 2500 parts per million (ppm), 200 ppm and 50 ppm. After seven months oi exposure, angiosarcoma las boon observed in mice at all levels, hut not in rats or hamsters. (more) VRD 0002 00 758 4 Page 2 of 2 Professor Maltoni reported at the OSHA hearings on vinyl chloride February 15 that he had observed the liver cancer in rats exposed four hours a day, five cays a week, to 250 ppm for up to 12 months. However, he did not find the cancer in testing at the 50 ppm level. The animal exposure study is continuing. Another MCAadministered study on the chemical, documenting the health experience of present and former employees who have worked with the material, the results of which also will be released, is expected to be completed in the near future. Further vinyl chloride testing is under consideration. MCA-3839 j; 8U B Z 00 0 "A0 tOPOSED RULES * 14215 (b) Technical services. used since that time. Only certain for ous drug- fluids after they have been in (1) The builder-developer proposing new subdivision which will have 10 or more dwelling sites will secure the services of a site planner, architect, mulations of PVC, however, are priorsanctioned for use in food packaging and therefore are exempt from classification as food additives and may be used with contact with devices composed in whole or in part of polyvinyl chloride. (6) The effect on blood and tissues of vinyl chloride extracted from devices landscape architect, or engineer, reg out pre-marketing clearance by the Food composed in whole or in part of polyvinyl istered or otherwise certiAed as qualified and Drug Administration. chloride Inserted or implanted in the in the state in which the subdivision Early in 1973, the Food and Drug Ad body. is to be constructed, to provide complete ministration began receiving reports of All persons in possession of such data planning, drawings, specifications, and possible migration problems of ingredi are urgently requested to submit it to the supervision on land, street, utility and ents of PVC bottles then being test mar Food and Drug Administration in writing grading development. keted for distilled spirits. As a result of (preferably in quintuplicate), if at all (2) Complete technical services will further analytical testing, the Commis possible on or before June 21, 1974. This be obtained and paid lor by the builder- sioner published the May 17, 1973 pro data should be sent to the Hearing Clerk, developer with his own funds. posal wherein he concluded that the use Food and Drug Administration, Room (3) At completion of construction (or of PVC for the packaging of alcoholic 6-86, 5600 Fishers Lane, Rockville, MD when construction will be accomplished foods may cause such foods to be adulter 20852. Received data may be seen in the in phases, at the end of each phase), the ated. No PVC bottles have been used for above office during working hours, Mon person who Is qualified and registered or such purposes since then. After the pub day through Friday. certified in the state in which the sub lication of the proposal, the Commis The Commissioner recently received a division is to be constructed and is pro sioner began investigating scientific re petition from the Health Research viding supervisory services during the period of work shall notify the FHA County Office in writing that all work has been completed in substantial conform ance with the approved plans and speci fications. . * 2. Amend 1804.67 as follows; ports regarding the possible migration of PVC container ingredients to nonalco holic foods as well. Agency action on this matter and on the earlier proposal is ex pected to be published shortly in the Federal Register. The Commissioner is also considering the applicability of this information to various drug products packaged in PVC, and to various devices Group, 2000 P Street NW., Washington, D.C. 20036, proposing to prohibit immedi ately the continued use of vinyl chloride as a constituent or propellant of cosmetic aerosol products and of polyvinyl chlo ride as a container material for any cos metic product which can leach out de tectable amounts of vinyl'chloride from the polyvinyl chloride container mate 1804.67 Streets. composed in whole or in part of PVC rial. The petitioner contends that there (a) New subdivisions and expansion of existing subdivisions. (1) Streets must conform to master street plans, design standards and con traction specifications of the applicable public body, city, town, county or state and the requirements of the FHA. De velopments with more than 20 sites shall have two accesses available, unless an exception is granted by the State Director. which may come in contact with drug fluids, or which may be Inserted or im planted in the human body. Because of the broad interest in the subject of vinyl chloride by both the pub lic and the scientific community because of its potential as a serious threat to the public health, the Commissioner has un dertaken an agency-wide effort to explore the problem in connection with those products within the jurisdiction of the Food and Drug Administration and to fashion the appropriate regulatory ac is substantia] evidence that vinyl chlo ride monomer is carcinogenic. A copy of the petition and letter of transmittal to the Commissioner are on file in the Office of the Hearing Clerk. The Commissioner has reviewed all cosmetic product ingredient statements on file with the agency, representing ap proximately 50 percent of current market formulations, as of February 1, 1974, and has ascertained that no information ex ists in these files indicating use of vinyl chloride in cosmetic aerosol products. (42 A.S.C. 1480'c: delegation of authority by tions that should be taken to assure lull Furthermore, the Cosmetic, Toiletry and See. of Agri.. 38 FR 140*4, 149*8, 7 CFSt 2.23; delegation of authority by the Asst. Sec. for Rural Development, 38 FR 14944, 14952, 7 CPR 2.70). protection of the public health. Repre sentatives of this agency are also mem bers of a Federal inter-agency task force formed to gather data on the overall ef Fragrance Association, Inc. (CTFA), has informed the Food and Drug Adminis tration that the results of a recent tele phone poll, covering 26 companies in Dated: April 15, 1974. fect of vinyl chloride on the total en- cluding the major aerosol hair jsprn\ Frank B. Elliott, Administrator, Farmers Home Administration. [FD Doc;74-0152 Filed 4-19-?4;8:45 am) . vironment and to initiate coordinated ac tion to minimize this impact. In connection with this search for in formation, the Commissioner is particu larly interested in receiving data in re manufacturers, show that no con:; contacted has manufactured pro.. ; containing vinyl chloride since 1973. In 1973, according to this inic- mu tton, two companies produced viny) chlo sponse to the following points relating to ride-containing products with a total DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE the use of polyvinyl chloride in contain volume of approximately 1.625,000 units. ers for food and cosmetics, and in de The CTFA estimates that the percentage vices: of hair spray cans manufactured in 1973 Food and Drug Administration 121 CFR Parts 310 and 700 J (1) The extent of usage of polyvinyl which contained vinyl chloride is less chloride by type of container or container than 0.4 percent. A copy of the infor liner and type of product. mation received from the CTFA is on VINYL CHLORIDE AS AN INGREDIENT OF (2) The vinyl chloride content in poly file in the Office of the Hearing Clerk. DRUG AND COSMETIC AEROSOL PROD vinyl chloride used to manufacture or There is no known past or present UCTS line various food and cosmetic contain usage of vinyl chloride as a propellant Notice of Proposed Rule Making ers, including description of the methods in food aerosol products. Any such use and extraction systems used to determine without a food additive regulation would In the Federal Register of May 17, this content. be a violation of the Federal Food, Drug, 1973 (38 FR 12931), the Commissioner of (3) The rate and level of vinyl chloride and Cosmetic Act. Food and Drugs published a notice of extraction from the aforementioned con With regard to drug products, the Food proposed rulemaking for prior-sanc tainers or their liners by various foods and Drug Administration has recently tioned polyvinyl chloride (PVC) resin. and cosmetics. Including data derived reviewed its files ar.d conducted a sur Polyvinyl chloride is a polymeric resin after periods of storage. vey of all known drag manufacturers of produced by polymerization of vinyl (4) The rate and level of percutaneous aerosol products to determine the extent chloride which was used as a component absorption of vinyl chloride from cos to which vinyl chloride is used as a com of food packaging materials prior to the metics and devices when in contact with ponent, including propellant, in such passage of the Food Additive Amend the skin or mucous membrane. products. The only known use of vinyl ments of 1958 and which has been widely (5) The vinyl chloride content of vari chloride in drug products has been as a FEDERAL tECISTER, VOL 39, NO. 78--MONDAY, APRIL 23, 1974 VJULJ.e 0 200 7586 14216 PR OSED RULES propellant in aerosol preparations. While made of any additional such manufac vidual may be exposed could be signifi all the information requested In the turers If and as they are located. cantly In excess of the safe level estab survey was not supplied by manufac Two cosmetic aerosol hair spray manu lished in connection with occupational turers, the review of the agency files and facturers commenced such recalls as of exposure. Evidence indicates that vinyl preliminary results of the survey Indi April 2, 1974 and a drug and cosmetic chloride inhalation can result In acute cate that vinyl chloride Is not currently manufacturer, Identified after a file toxicity manifested by dizziness, head being used in aerosol drug products. There are no approved new drug appli cations for vinyl chloride as a component of any drug. There Is evidence, however, search, began recall of seven drug and threo cosmetic aerosol products as of April 8, 1974, following an April 4, 1974 request. ache, disorientation, and unconscious ness where inhaled at high concentra tions. Studies also demonstrate carcino genic effects In animals as a result of that manufacturers of some over-thecounter drug products used vinyl chlo ride as a propellant until 1973. To determine the full extent that vinyl Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 502. 505, 601(a). 701(a); 52 Slat. 1050-1055, as amended; 21 TJjS.C. Inhalation exposure to vinyl chloride. Furthermore, vinyl chloride has recently been linked to liver disease. Including liver cancer, in workers engaged in the chloride is used in drug products and to determine if any additional action is needed to protect the public, there is published elsewhere In this issue of the Federal Register, a notice, pursuant to 132.7(a) (4) (21 CFR 132.7(a)(4)). Of the regulations under the Drug Listing Act of 1972, requiring all registrants to submit a list of all drug products mar keted containing the ingredient vinyl chloride or packaged in containers com posed of or lined with polyvinyl chloride. *1710 Commissioner has determined that there are sufficient scientific data on which to base a decision that: (1) vinyl chloride presents an unnecessary hazard to the public health when it is used as an ingredient in cosmetic aerosol prod ucts and that such use should be banned, and (2> vinyl.chloride, when used as an Ingredient in drug aerosol products, Is not generally recognized as safe and ef fective, Is a new drug within the meaning of section 201 (p) of the Federal Food, Drug and Cosmetic Act. and requires an approved new drug application as a con 352. 355. 361(a). 371(a)) and under au thority delegated to the Commissioner of Food and Drugs (21 CFR 2.120), It Is proposed that Parts 310 and 700 be amended as follows: 1. By adding a new fi 310.506 to.Sub part of Part 310 to read as follows: 310.506 Use of vinyl chloride as an ingredient, including propellant, of aerosol drug products. (a) Vinyl chloride has been used as a propellant in aerosol drug preparations. Evidence indicates that vinyl chloride Inhalation can result In acute toxicity manifested by dizziness, headache, dis orientation, and unconsciousness where inhaled at high concentrations. Cardiac effects, bone changes, and degenerative changes in the brain, liver, and kidneys have been reported in animals. Studies also demonstrate carcinogenic effects in animals as a result of Inhalation expo sure to vinyl chloride. Recently, vinyl chloride has been linked to liver disease, including liver cancer, in workers en polymerization of vinyl chloride. It is the view of the Commissioner that vinyl chloride Is a deleterious substance which may render any cosmetic aerosol prod uct that contains it as an ingredient injurious to users. Accordingly, any cos metic aerosol product containing vinyl chloride as an ingredient is deemed to be adulterated under section 601(a) of the Federal Food. Drug, and Cosmetic Act. (b) Any cosmetic aerosol product con taining vinyl chloride as an ingredient shipped within the jurisdiction of the act is subject to regulatory action. Interested persons may, on or before May 22,1974, file with the Hearing clerk. Food and Drug Administration, room 6-86. 5600 Fishers Lane, Rockville, MD 20852, written comments (preferably in quintuplicate) regarding this proposal. Comments may be accompanied b7 a memorandum or brief in support thereof. Received comments may be seen in the above office during working hours, Monday through Friday. dition of marketing. There is ample evidence that vinyl chloride inhalation can result in acute toxicity manifested by an array of symp gaged in the polymerization of vinyl chloride. (b> The Commissioner finds that there is a lack of general recognition by quali Dated: April 16. 1974. A. M. Schmidt, ComTnissicmer oj Food and Drags. toms. including unconsciousness as a re fied experts of the safety or effectiveness [FR Doc.74-9232 Filed 4-I9-74;8:45 ami sult of high concentration of inhalation. of aerosol drug preparations containing Cardiac effects, bone changes, and de vinyl chloride as an Ingredient, includ generative changes in the brain, liver, ing propellant. Therefore, any such prod and kidneys have also been reported In uct containing vinyl chloride is a new DEPARTMENT OF TRANSPORTATION animals. Reported studies also demon drug and a new drug application ap COAST GUARD strate carcinogenic effects in animals as proved under section 505 of the Federal a result of inhalation exposure to vinyl Pood. Drug, and Cosmetic Act is re 133 CFR Part 117 J chloride. Of most significance, however, quired for marketing. [COD 74U5J Is the fact that vinyl chloride has been linked to liver disease, including liver cancer, in workers engaged in the poly merization of vinyl chloride to PVC. The scientific articles providing this evidence (c) A completed and signed "Notice of Claimed Investigational Exemption for a New Drug*' (Form FD-1571). as set forth in I 312.1 of this chapter, is re quired to cover clinical investigations NEW RIVER SOUND AND STRANAHAN RIVER, FLA. Proposed Drawbridge Operation Regulations are on file in the Office of the Hearing designed to obtain evidence that such At the request of the Florida Yacht Clerk. In view of this evidence, the Com preparations are safe and effective for Club Council, the Coast Guard is con missioner concludes that the banning of the purposes intended. sidering revoking the regulations for the vinyl chloride as an ingredient in drug <d) Any such drug within the juris East Las Olas Boulevard drawbridge and cosmetic aerosol products is re diction of the act which is not in accord across the Atlantic Intracoastal Water quired. These products are often used with this regulation is subject to regula way in Fort Lauderdale, Florida, to re in the confines of a small room where tory action. . quire that the draw open on signal. Pres tho level of vinyl chloride to which the Individual may be exposed, although usually only for a short time, could be 2. By adding a new 700.14 to Subpart B of Part 700 to read as follows: ent regulations allow closed periods from November 15 through May 15 from 7 a.m. to 6 p.m. during which the draw need significantly in excess of the safe level 700.1-4 Use of vinyl chloride as an in only open on the hour ar.d hall hour. This established in connection with occupa gredient, including propellant of cos change is being considered for the fol tional exposure. metic aerosol products, lowing reasons: As a corollary to this conclusion, the (a) Vinyl chloride has been used as an (a) The regulations presently In force Commissioner has requested all known ingredient in cosmetic aerosol products were issued on March 15, 1553 (15 FR manufacturers of such products with including hair sprays. Where such aero 1461), and were amended on July 2.1953 supplies still on the market to recall sol products are used In the confines of (18 FR 3782). October 23. 1955 (29 FR these supplies from the market to the re a small room, as is often the case, the 8118), and October 20.1956 (21 FR8084). tail level, and similar requests will bo level of vinyl chloride to which the Indi These regulations were issued to ease ve- FEDERAl REGISTER, VOL 39, NO. 78--MONDAY, APRIL 22, 1974 VRD 0002007587 142-**'' NOTICES the uenial oi'der Issued against the re dressed to: Central Reference and Rec halation can result in acute toxicity spondent on February 28, 1972 (37 FR ords Inspection Facility, U.S. Depart manifested by an array of symptoms in 8306). ment of Commerce, Washington, D.C. cluding unconsciousness as a result of Dated: April 12,1976. Raver E. Meyer, 20230. Dated: April 17,1974. high concentration inhalation. Cardiac effects, bone changes, and degenerative changes in the brain, liver, and kidneys Director, Rawer H. Meyer, have also been reported In animals. In Office oi Export Administration. Director, Office of Export Ad addition, there are studies demonstrat |PR Doc.74-9080 Filed 4-19-74:8:45 wnj ministration, Bureau oi EastWest Trade, Department of ing the carcinogenic effects in animals as a result of inhalation exposure to vinyl Commerce. chloride, and it has been linked to liver COMPUTER SYSTEMS TECHNICAL ADVISORY COMMITTEE |FR Doc.74-9009 Filed 4-19-74;8:45 am) disease, including liver cancer, in work ers engaged in the polymerization of the Notice of Meeting Pursuant to the provisions of the Fed eral Advisory Committee Act (Public Law 92-463). notice is hereby given that a meeting of the Licensing Procedures Subgroup of the Computer Systems Technical Advisory Committee will be held Monday, April 29, 1974, at 1:30 p.m. in Conference Room. A, Main Com merce Building, 14th and Constitution Avenue, Washington, 'D.C. Members advise the Office of Export Administration. Bureau of East-West Trade, with respect to questions involv ing technical matters, worldwide avail ability and actual utilization of produc tion and technology, and licensing pro cedures which may affect the level of export controls applicable to computer systems, including technical data re lated thereto, and including those whose export is subject to multilateral (COCOM) controls. Agenda items are as follows: DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE monomer to polyvinyl chloride. Polyvinyl chloride, a polymeric resin produced by polymerization of vinyl Food and Drug Administration JNADA No. 48-236V) chloride, is used in drug packaging materials. There is evidence of vinyl chloride migration when polyvinyl chlo AGRITRONICS CORP. ride is used in packaging material for Agritronics Swine Premix T-S; Withdrawal of Approval of New Animal Drug Application Pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (sec. 512, 82 Stat. 343-351; 21 U.S.C. 360b) and under authority delegated to the Com missioner of Food and Drugs (21 CFH 2.120), the following notice is issued: products containing alcohol. There have also been reports of the possible migra tion of polyvinyl chloride container ingredients to non-alcoholic products as well. Because of this it is necessary to give special study to such packaging material to determine if it is safe for its intended use. For these reasons it Is essential that Agritronics Corp., Cll 24th St., Dcs the Commissioner have knowledge of Moines, IA 50311. has requested that its every drug product currently marketed NADA (new animal drug application) in the United States that contains vinyl No. 48-236V be withdrawn is accordance chloride as an ingredient, and informa With 135.28(d) (21 CFR 13528(d)) on tion regarding every marketed drug the grounds that the drug is not being product packaged in a polyvinyl chloride marketed. Notice is given that approval container or in a container iined with of NADA No. 48-236V for Agritronics polyvinyl chloride. Such information is Swine Premix T-S, which contains ty- . necessary for determining if there is ade 1. Opeulng remarks by the Chairman, losin and sulfamethazine, is hereby quate evidence whether drugs containing Computer Systems Technical Advisory withdrawn. vinyl chloride or packaged in containers Committee. 2. Appointment of subgroup chairman. 3. Presentation ol papers or comments by the public. 4. Discussion of export licensing proce dures relating to computer systems. 5. Executive Session: Continuation of dis cussion' of export licensing procedures. TTie public will be permitted to attend the discussion of agenda items 1--4. and a limited number of seats will be avail able to the public for these agenda items. To the extent time permits, members of the public may present oral statements to the subgroup. Interested persons are also invited to file written statements with the subgroup. With respect to agenda item 5, "Exec utive Session." the Assistant Secretary of Commerce for Administration, on De cember 20, 1973, determined, pursuant to section 10(d) of Public Law 92-463, that this agenda item should be exempt from the provisions of sections 10 (a) (l) and (a)(3), relating to open meetings and public participation therein, because the meeting will be concerned with mat ters listed in 5 U.S.C. 552(b) (1). Further Information may be obtained Effective date. This notice shall be ef fective April 22, 1974. Dated: April 15,1974. SamD. Fine, Associate Commissioner ior Compliance. IFRDoc.174--9114 Filed 4-19-74;8:45 am) HUMAN DRUGS CONTAINING VINYL CHLORIDE OR PACKAGED IN POLY VINYL CHLORIDE CONTAINERS Notice to Drug Manufacturers, Packers, and Distributors Elsewhere in this issue of the Federal Register (39 FR 14215) the Commis sioner of Food and Drugs has proposed that all aerosol drug products containing vinyl chloride as a component, including propellant, are new7 drugs and subject to regulatory proceedings-unless the prod ucts are the subject of new drug appli cations approved pursuant to section 505 of the Federal Food. Drug, and Cosme tic Act. That proposal is based on scien tific data demonstrating that vinyl chlo ride is not generally recognized as safe composed of, or lined with, polyvinyl chloride are safe and effective for their intended purposes and what action, if any. is required to protect the public health. Section 510(J)(3) of the act, as added by the Drug Listing Act of 1972, author izes the Commissioner to require each registrant under section 510 of the act to submit a list of each drug product which the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution and which contains a particular ingredi ent, when the Commissioner has made a finding that the submission of such a list is necessary to carry out the pur poses of the act. For the reasons stated above the Commissioner so finds with regard to drugs containing vinyl chlo ride. As packaging materials are an integral part of the drug product, the Commissioner also so finds with regard to drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride iir.crs. In addition to the required list of drugs containing vinyl chloride and a required list of drug products packaged in poly from John L. Collins, Chairman, Com and effective as a component, including vinyl chloride containers or in containers puter Systems Technical Advisory Com propellant, of a drug product. with polyvinyl chloride liners, the Com mittee, IBM World Trade Corporation, The Food and Drug Administration Is missioner is requesting, but not requir 1C01 K Street NW,, Washington, D.C. aware that vinyl chloride has been used ing, that certain other information be 20006 (A/C 202-633-6000). as a propellant in aerosol drug prepara submitted. The Commissioner acknowl Minutes of those portions of the meet tions. but has no information that vinyl edges that some of the information being ing which are open to the public will chloride Is currently being used in the requested has also been requestea in the be available 30 days from the date of manufacture of drag products. There is regulations Implementing the Drug List the meeting upon written request ad- ample evidence that vinyl chloride In ing Act of 1972, and will be available FEDERAL REGISTER, VOL. 39, NO- 78--MONDAY, APRIL 22, 1974 VRD 0 0 0 2 0 0 7 m NOTICES* 14239 from that source. However. It will greatly simplify the compilation of tills Infor mation if it Is included In this sub mission. Therefore, pursuant to the provisions of the Federal Food, Drug, and Cosmetic Act (secs. 201, 510. 701(a), 52 Stat. 10401042, as amended, 1053. as amended, 1055, as amended; 21 TLS.C. 321, 360, 371(a); 42 U.S.C. 262) and under au thority delegated to the Commissioner (21 CFR 2.120), each registrant under section 510 of the act is required to sub mit to the Food and Drug Administra tion a list of-all human drugs which are being manufactured, prepared, propa gated, compounded, or processed for commercial distribution and which con tain vinyl chloride whether or not the vinyl chloride is an active or inactive in gredient and a list of all human drug products packaged in polyvinyl chloride containers or in containers with poly vinyl chloride liners as follows: 1. Reporting firm name, address, and registration number. 2. List of drugs containing vinyl chloride (by trade name, if any. and established name, If any) and a list of drug products for which polyvinyl chloride is used as a con tainer or a container liner (by trade name, if any, and established name. If any). It is requested but not required that the following information also be sub mitted: 3. National Drug Code (NDC) If one has been assigned. 4. A statement whether the drug is mar keted over the counter or limited to pre scription distribution. 5. Route of administration. 6. Amount of vinyl chloride to average dally dose. 7. Quantity of drug distributed (number of dosage units) during previous 12 months. 8. A copy of the label and labeling. In addition to the information requested in items 1 through 8 (excluding item 6) for drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride liners it is requested, but not required, that the following in formation be submitted. S. A statement of the vinyl chloride con tent In polyvinyl chloride used for the manu facture of the drug container or container lining. Include description of the methods and extraction systems used to determine this content. If this Information is not known, provide the name and address of the drug container or container liner supplier and/or manufacturer. 10. The rate and level of extraction of vinyl chloride from the polyvinyl chloride containers or container liners by the particu lar drug or by any other extraction or rolvent systems, Including data derived niter periods of storage. Where such information is not known, hut Is or'may be available from the supplier or manufacturer of the container or liner, provide the name and address of such supplier or manufacturer. 11. The rate and level of absorption of vinyl chloride as an ingredient or of vinyl chloride extracted from a polyvinyl chloride container or liner by the drug contained on an average dally dose. Where such Informa tion Is not known, but Is or may be available from the supplier or manufacturer of the container or liner, provide the name and address of such supplier or manufacturer. 12. Name and address of the manufacturer of the polyvinyl chloride resin, where such Information is known. This Information shall be submitted to: Department of Health, Education, and Wel fare Food and Drug Administration _____ Bureau of Drugs. Drug Listing Staff (HFD-7) 600 Fishers Lone Rockville, ilD 20853 by May 22,1974. Dated: April 15. 1974. A. M. Schmidt, Commissioner of Food and Drugs. IFR Doc.74-9231 Filed 4-19-74;6:45 am] ADVISORY COMMITTEES Notice of Meetings Pursuant to the Federal Advisory Com mittee Act of October 6. 1972 (Public Law 92-463. 86 Stat. 770-776; 5 U.S.C. App.), the Food and Drug Administra tion announces the following public ad visory committee meetings and other re quired information in accordance with provisions set forth in section 10(a) (1) and (2) of the act: Committee Date, time, ItUoe Tyj of meeting and contact person 1. Panel t*n Review ol lntonv.il Analz.vic including Antirlitu- rntilic Drugs. May 8 and 9,9 a.ai.. Cimft-r- ones Room C. Park lawn Bide.. 5COO Fish&rs Lana, Rockville, Md. Open May 6, 0 a.m. to 10 a.m., closed May 8. alter 10 a.in., cloned May 9. Lee Oeisinnr. Room 10Um, .%00 Fi'hers I.ane, Rockville. Md. 20SS2, SOI--H3--<000. Purpose. Reviews and evaluates avail able information concerning safety and effectiveness of active ingredients of cur rently marketed non-prescription drug products containing Internal analgesic agents. Agenda. Open session: Comments and presentations by interested persons. Closed session: Continuing review of nonprescription internal analgesic drugs under investigation. Committee name Date. time, place Type of meeting eud contact [rsoa 2. Fane! Mi Review of OrtliopacUie Device* Mav it. 9 a.m.. Hotel IHv.li Motor Lodgo, Suit Lake City, Utah. Open 9 a.m. to 10 a.m., closed after 10 a.m. Jumes K. VYjlo (ItIM-IJO), WOO Kisliers Lui.o, Koekvillo. Md. 205S2, 301-413-3630. Purpose. Reviews and evaluates avail able data concerning safety, effective ness, end reliability of orthopaedic de vices currently in use. Agenda. Open session: Comments and presentations by interested persons. Closed session: Continuation of review of previous classification results and iden tification of specific areas for standards for those devices classified as requiring standards. Commute* oamo Date. time, place Type of mooting and contact porno t. Panel on Review of Dodtal Devices. May 23 and 23, 9 am., Amor* lean Dental Association Bldg.. Chi cago, 11L Open May 22,9 i n. to 10 a.m.. closed May 22 after 10 a.m.. closed May 23. Robert S. Kennedy. Ph.T)., niPM-l'jJ) 6300 Fislicr? Lare. Itoetvillo. Md. 20SS2, 301-443-3370. Purpose. Reviews and evaluates avail able data concerning the safety, effec tiveness, and reliability of dental devices currently in use. Agenda. Open session: Comments and presentations by interested persons; de vice classification; and device legisla tion. Closed session: Continuing review and classification of dental devices. Agerfda items are subject to change as priorities dictate. During the open sessions shown abeve. interested persons may present relevant information or views orally to any com mittee for its consideration. Information or views submitted to any committee in writing before or during a meeting shall also be considered by the committee. A list of committee members and sum mary minutes of meetings may be ob tained from the contact person for the committee both for meetings open to the public and those meetings closed to the public in accordance with section 10(d) of the Federal Advisory Commit tee Act. Most Food and Drug Administration advisory committees are created to adrise the Commissioner of Pood and Drugs on pending regulatory matters. Recommendations made by the commit tees on these matters are intended to result In action under the Federal Food. Drug, and Cosmetic Act, and these committees thus necessarily participate with the Commissioner in exercising his law enforcement responsibilities. The Freedom of Information Act rec ognized that the premature disclosure of regulatory plans, or indeed internal discussions of alternative regulatory ap proaches to a specific problem, could have adverse effects upon both public and private interests. Congress recog nized that such plans, even when final ized, may not be made fully available in advance of the effective date without damage to such interests, and therefore provided for this type of discussion to remain confidential. Thus, law enforce ment activities have long been recog nized os a legitimate subject for confi dential consideration. These committees often must consider trade secrets and othc-r confidential in formation submitted by particular man ufacturers which the Food and Drug Administration by law may not disclose, and which Congress has included within the exemptions from the Freedom of Information Act. Such information in cludes safety and effectiveness informa tion, product formulation, and manu facturing methods and procedures, all FEDERAL REGISTER, VOL 39, NO. 78--MONDAY, APRIL 22, 1974 *VRD 90020 7*89 TRIP REPORT PLACE: SUBJECT: ATTENDED BY: DATE: SPI Meeting, Washington Hilton, Washington, D. C. VCM Toxicity and SPI Involvement R. W. Gerwig F. Kennedy April 16, 1974 The meeting was chaired by Tony Viltone, Goodrich, and after considerable discussion a committee was appointed. Harry Conners, Diamond Shamrock, will chair the committee whose members include R. W. Gerwig, Conoco; Joe Fath, Tenneco; Lee Kuhn, Stauffer; Joe Jageman, Pantesote; Art Steele, Union Carbide; and persons to be designated from Dow, Goodrich and Waugatauh. A steering committee composed of Ross Adams, Air Products; Harry Couner, Diamond Shamrock; Jim Williams, Dow; Joe Fath, Tenneco; and Tony Viltone, Goodrich, was also appointed. The committee was assigned the following tasks as related to preparing an industry position for presentation to OSHA: 1. Collect human health data from all plants with at least 20 years of operation. 2. Recommend a time oriented type of standard for VCM exposure. 3. Monitor the MCA animal exposure studies and recommend and support additional studies. 4. Define standards; i.e., the techniques, methods and hardware recommended. 5. Recommend VCM content of resin shipped. Industry took position that polymer could contain less than 0.1% VCM; labor's position was 0.01% VCM or less. 6. A sub-committee of the main committee will accumulate data regarding fabricator exposure. Fabricator companies should not be identified when data are submitted to the committee. Ross Adams, Air Products, will contact A. D. Little and other candidates regarding the preparation of the economic impact of a zero-level regulation from OSHA. Preliminary indication from A. D. Little was a $60,000-$80,000 cost and 6 to 8 weeks. VRD 000200759? TRIP REPORT SPI Meeting, Washington, D. C. VCM Toxicity and SPI Involvement April 16, 1974 Viltone stated that ORC (Organization of Research Councilors) had retained Georgetown University to do a mortality study covering the fabricating industry. (This study is similar to the MCA sponsored study of the VCM/FVC industry by Tabershaw Cooper.) Residual VCM in Polymer Several companies mentioned the residual VCM in their product lines and apply to values "out of bag or car." Stauffer - emulsion is less than 20 ppm, low molecular weight emulsion 800-1600 ppm, high molecular weight 300-600 ppm. Air Products - pearls 10-50 ppm, pipe type syspension 1000*, copolymer 300-400 ppm. Goodrich - man process - coarse fraction, above 1000 ppm, fine fraction 200-300 ppm. Union Carbide - suspension - "goes down to unmeasurable level." Pantesote - rigid calendered sheet, 10-85 ppm, resin shipped at 100 ppm goes to 5-10 ppm, lab extruder "at end of pipe found 500 ppm." Everyone agreed that VCM weathered from resin reasonably easily. Shut Down Levels R. W. Gerwig indicated Conoco could operate at 20 ppm level (question probably referred to ceiling not TWA); Goodrich, Carbide and a few others could at 30 ppm; the remainder could operate at either 40 or 50 ppm, more at 50 ppm. Jim Williams, Dow, told several people that Dow's VCM plants operated at 10 TWA, 25 ceiling, and 50 evacuation and that V. K. Rowe had made that same recommendation to John Stender, Assistant Secretary of Labor, on Monday in response to a telephone call by Stender. Such a standard would be much better than establishing a ceiling limit at lower levels as the emergency temporary standard did. 4/23/74 c: RWG-JDBu-JJL-KLS-JDBr-LNV-WRS-DVP-(EAS-REL) 'OSF.PH E. KELLER EROMir II HECKMAN CHARLES M MEEHAN WILLIAM H. BOROHCSAK1. JR JJOUEliT R.TIRHNAN WAYNE V BLACK David l hill MARTIN W. BERCOV1CI EDWIN T! SPIEVACK PETER M. NEMKOV JOSEPH K tLADLET CAROLE C HARRIS WILLIAM W POOH LAW OFFICES Keller and Heckman IlSO 17T-! STREET, N. W. SOITE lOOO WASHINGTON, D. C. S003G Q) M ' ^ Rw . FK*' 7 JL- TF6HRr c TELEPHONE eo2 e^G-eroo CARLE ADDRESS "KEIJiAN'' 33 C3 C5 Ca <fS ** *> $ <*1 sp -4* April 16, 1974 Dr. Karl A. Hochschwender American Hoechst Corporation Route 202-206 North Bridgewater Post-Office Box 2500 Somerville, New Jersey 08876 Res Proposed Regulation of Food-Contact Articles in the Household; 39 Fed. Reg. 132 85, et seq. Dear Karl: We have reported several times recently that FDA was considering the revocation of the so-called "housewares exemption" under which utensils, dinnerware and similar articles used in the home were exempt from the Food Additives Amendment of 1958. The formal FDA action in this connection by means of a proposed Rule Making was published in the Federal Register on April 12, 1974. We are enclosing copies of the pertinent pages from the Federal Register for your ready reference. It will be apparent to you that in this proposed Rule Making the Food and Drug Administration is asserting jurisdiction over dinnerware, utensils and other housewares, but is also once again reaffirming that if a substance does not migrate under intended conditions of use, it is not a food additive. As we see it, in its citation of legislative history in the preamble to this proposal, the Food and Drug Administration has gone to almost tortuous care to rationalize away and thereby minimize the significance of the explicit statements expressing Congressional intent to the effect that dinnerware or utensils were not in tended to be the subject of coverage under the 1958 Food i \ f Dr. Karl A. Hochschwender April 16, 1974 Page Two Additives Amendment. Nevertheless, we believe that in light of recent Supreme Court decisions, it is not un reasonable to anticipate that the FDA position would be upheld by the courts should its jurisdiction be challenged in a qase in which -a health hazard was shown to exist. Although the Food and Drug Administration refers to "no migration" in the preamble, and uses the statutory definition of a food additive in the proposed regulation which implies that a substance that does not migrate is not a food additive, FDA still has not defined "no migration" in operational terms. In following up on this, I discussed the situation in some detail and was advised by Peter B. Hutt, Assistant General Counsel of the Department of Health, Education and Welfare (in effect. General Counsel for FDA) that the time might be appropriate for filing a Food Additive Petition that would effectively define "zero migration" for indirect additives. It is our intention to prepare such a Petition promptly to be able to circulate a draft along with draft Comments on the subject proposed Rule Making for your consideration. In this connection, we are requesting those receiving copies of this letter who wish to do so to submit to us your suggestions for the preparation of Comments. In order to circulate draft Comments and leave time to prepare final Comments within the permitted sixty day period, we are requesting your initial responses by May 1, 1974. We plan to circulate draft Comments embodying any recommendation's we might receive and a draft Petition to establish a "zero" standard for migration as close to May 15 as we can. In the meantime, as we await your suggestions, we hope that those of you who have any questions will not hesitate to contact us. Cordially yours. Enclosures cc: To All Members of SPI Food,M3"rug and Cosmetic Packaging Materials Committee / 96S100-Z000 < -WA - PROPOSED RULES \ ' ^ )l32f In Put. to Rico, including Industry Com mittees Nos. 118. 119-A, 119-B, 120-A, 120-B, 121-A, 121-B, and 12I-C and gave notice of dales of Investigations and hearings. The purpose of the hearings was to review the wage rates in those industries which were bcl-ow $1-G0, the then highest minimum rate under the Fair Labor Standards Act. except in agriculture where minimum rates below $1.30 were to be considered. Under section 5(d) of the Act, the Secretary is obliged to fur nish to such committees such data as he has available on the matters referred to the committees. Section 511.6, Title 29, Code of Federal Regulations pre scribes the use of surveys. As the result of the enactment of the Fair Labor Standards Amendments of 1974, Pub. L. No. 93-259, April 8. 1974, the data ob tained in surreys in industries arc now inadequate; the criteria for use in recom mending wage? yates are changed sub stantially, and the hotel and restaurant industries wage rates have been in creased to those in the various States. Accordingly, pursuant to section 5 of the Fair Labor Standards Act of 1938 <29 U.S.C. 205) as amended, Reorganization Plan No. C of 1950 <3 CFR 194953 Comp. p. 1C 34), and 29.CFR Part 511. I postpone the meetings of Industry Committees Nos. 118, 119-A, 119-B, 120-- A, 120-B, and 121-A. New dates for the convening of the postponed Industry committees will be published in the Federal Register within the next few weeks. These industry, committees will hold their meetings within the period be tween September 1, 1974 and Decem. ber 15, 1974. Industry Committees Nos. 121-B and I21-C for the Hotels and Restaurant Industries are dissolved. Signed at Washington, D.C., this 9th of April 1974. : Peter J. Brennan, - - - Secretory of Labor. [FR Doc.74--8482 Filed 4-11-74:8:45 am] ` .`-/' DEPARTMENT OF HEALTH, , EDUCATION, AND WELFARE - Food and Drug Administration [21 CFR Part 121 ] SUBSTANCES !N FOOD-CONTACT AR TICLES IN THE HOUSEHOLD, FOOD SERVICE ESTABLISHMENTS, AND FOOD DISPENSING EQUIPMENT Food Additive Status Since enactment of the Food Additives Amendment of 1958 (Sentcmbcr C. 1958, . Pub. L. 85-929. 72 Slat. 1784), letters and oral opinions have at times been issued by personnel of the Food and Drug Ad ministration advising that ordinary houseware articles such as cutting boards, pots and pans, and eating uten sils. as well or. at:ents used to rlc.-m simli ^-housewares, arc not subject to regula tion under section 40D of the Federal Food. Drug, and Cosmetic Act <72 Slat. 1785; 21 U.S.C. 348). The FDA has also had a wcU-cstiiblishcd regulatory policy that lead (or other heavy metals) in pot tery dinm_. ware, in cnnniclware, or in ' The . legislation also covers substance-- pewter articles, which may migrate to . which may reasonably be expected to become food held in the dinnerware (or enamel- ware or pewter) and poison the con sumer, is subject to regulation as a "food n component of any food or to nflect the characteristic* of any food. These sirbstanre. arc generally referred to as "incidental addi tives." additive" within the meaning of section The principal examples of both Intention:*: 201 (s) of the act <21 U.S.C. 321), Food and Incidental additives arc substances in- additive regulations have been promul tended for use in producing, manufacturinL- gated governing numerous substances used in food-contact surfaces, and in sanitizing solutions for such food-contact surfaces, in 21 CFR Part 121, Subpart F. Because, of resulting confusion with regard to the applicability of the Fed eral Food, Drug, and Cosmetic Act to packlng, processing, preparing, treating, packaging, transporting, or holding food. On the other hand, substances which ma- accidentally get Into a food, as for example paints or denning solutions used in joe-: processing plants, are not covered by th.' legislation. These additives arc general:-, referred to ns "accidental additives." guir'e various houseware, food service, and these substances If properly used may r.<v food dispensing products, including reasonably be expected to become n con-., cleaning agents, determined that the Commissioner has it is in the interest of ,, ponent of a food or otherwise characteristics of a food. to uilcct the efficient enforcement of the act to These statements make it clear that Con promulgate a regulation articulating the gress intended to regulate all substancescope of tire food additive provisions of (except those generally recognized a = the act with regard to such products- safe or specifically exempted by section The definition of a food additive is ex 201(e) of the act) which become or which tremely broad and easily covers all sub mny become a component of food bv or.-.- stances which may reasonably be ex means other than purely accidental con pected to migrate to food from food- . tamination. contact articles. Section 2Gl(s) provides The House Select Committee to In that: vestigate the Use of Chemicals in Food The term "food additive" means any sub stance the Intended use of which results or may reasonably be expected to result, directly or indirectly. In its becoming a component or and Cosmetics which originally recom mended 'a- food additives dmendmer.showed a similar desire for providing th;strongest possible consumer protection, otherwlso affecting the characteristics of any food (Including any substance Intended for use In producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; *), if such substance is not generally recognized, among experts qualified by scientific train through comprehensive food adcutiw legislation. The committee's report to the Congress (House Report No. 235G, 82u Cong., 2d sess.), recommended: the (food additive] legislation shou'C provide' that evidence that tbo chemical ing and experience to evaluate Its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use; 1 This statutory language provides no basis for an exemption for any houseware, food service, or fopd dispensing ar ticle or cleaning agent, and shows clearly that Congress meant to regulate all sub stances not generally recognized by ex perts as having been shown to be safe which become or which may reasonably be expected to become, directly or in directly, a component of any food unless specifically exempted by section 201 (s). (Although color additives are specifically exempted from the definition of food additives by section 201(s) (3), they are regulated by sections 70G and 402(c) of the act (21 U.S.C. 376, 342) regardless of safe, and docs not produce harmful chcmicr-. reactions In tbo end food product, should be submitted to the Food and Drug Admin istration for clearance before tho chemical i. utilized. Several manufacturers of food pack aging and wrapping materials testified r.' the hearings on the Food Additliv Amendment of 1958 and. while so:r.< favored and others opposed the legisla tion, it was generally recognized thr.substances used to package and hold ioo'. would be-subject to the new IcgiMatio. where migration occurred. See, for ex ample, the statement by Frederick F. Leinbach, representing the America;: Paper & Pulp Association, "the over.'.:: national association of the paper and pulp industry," speaking with regard ic packaging materials: intended use. See 21 CFR 8.1(f).) If there are cxtrnctables, If those materia:- The legislative history of the Food Additives Amendment of 1958 also shows that Congress recognized and intended that all substances which may reason ably be expected to become r component of any food are "food additives'' (unless siJecLfically exempt under section 201 (s) of the act). Both the House and Senate Reports on the Food Additives Amend could reasonably bo expected to become : component of the packaged food, they the., become additives, and we feel they should ictreated ns additives. [Hearings Before a Sub committee of the Committee on Interf. and Foreign Commerce. House of Representa tives, Eighty-fifth Congress, on Dills* tAincud the Federal Food, Drug, and Cosmct. Act with Respect to Chemical Additives l: Food.) ment of 1958 contain the following text Congressman John Bell Williams, th-: (House Report No. 2284, 85th Cong.. 2d Chairman of the subcommittee which scss., p. 3, July 28. 1950; Senate Report prepared the food additive leg;.sLat;c:: No. 2422, 85th Cong., 2d sess., p. 5. August reflected this understanding in the con 18,1938): gressional debate on the bill: ' The legislation covers substances which Since the food additive bill, HR: 122;* arr added Intentionally to food. These addi passed tho House, I have received an In- tives are generally referred Vo as "intentloiuil qulry os to how this legislation aficcts Ik.- additives," packaging Industry. Of course, packaglr.;- ( 1 FEDERAL REGISTER, VOL 39, NO. 72--FRIDAY, APRIL 12, 1974 59 7 13286 PROPOS' RULES ordinarily la not intended or reasonably ex tha production, storage, or transportation without an applicable food additive regu- pected to become a part of food anil there fore would not come under the bill. Tho erm "otherwise affecting the characteris es of any food" refers to an effect not gen erally recognized as safe among experts qual ified by scientific training and experience of Any raw agricultural commodity; or (3) a color additive: or (4) any substance used In accordance with n sanction or approval granted prior to [September 6, 1050) pursuant to this Act, the Poultry Products Inspection Act lation. in reliance upon a prior statement from FDA that the act was not applicable to the product. The proposal therefore provides that by December 31, 1974. manufacturers must either be in com to evaluate the safety of food additives; but or the Meat Inspection Act ; or pliance with existing regulations or have . innocuous effects of packaging. such as pro (5) a new auimnl drug. / filed a food additive petition covering the tection from dirt, retarding moisture loss, preserving shape, providing convenience In use, handling, and storage, and the like, would not be covered. | congressional Itccord of August 23, 1038. Ci'.h Cong.. 2d w>ss.) Similarly. Congressman Williams also staled that ordinary housewares would not he subject to the new law; Had Congress meant to exempt specific articles such as dinnerwarc and cooking utensils from the coverage of the act, therefore, it would have been a simple matter for it to do so. Finally, section 409(c)(5) of the act provides that: use of a given substance or article. Of course, if there is no migration of a sub stance lo food, or if the substance is gen erally recognized as safe at the level of migration under the conditions of use in volved, the substance is not a food addi tive and no petition is required. An opin ion with respect to migration or GRAS This bill Is not Intended, for example, to give the Food and Drug Administration au thority to regulate the use of components * In determining whether a proposed use of a food additive is safe, the Secretary shall consider among other relevant factors-- In dlnnerware or ordinary eating utensils, status may be obtained from the Food and Drug Administration upon request. No transition period is justified, how ever. for migratory substances in pottery f Congressional Record, 104; 17418. J (B) the cumulative effect of such additive dlnnerware, enamelw'are, or pewter. FDA Thus, ordinary inert articles, from which In the diet of man has for several years conducted a widely ' .no migration to food occ.urs arc clearly It is not possible to make an accurate de not subject to the act, but there was no termination of' the cumulative effect of congressional intent to exempt all food- an additive without taking into account contact articles used in the household, all means by which that additive may food service establishments, and food reasonably be. expected tb enter man's dispensing equipment. diet. Any reports of adverse effects re Other provisions of section 409 of the sulting from migration of unsafe chem act also manifest a strong congressional ical additives from articles such as desire to regulate all intended vises of dinnenvare and eating utensils would food additives. Section 409(a) provides require prompt regulatory action. There that: fore, to exempt dinnenvare, eating uten A food additive shah, with respect to any particular use or intended use of such addi sils and other houseware, food service. . and food dispensing articles which may tives, be deemed to be unsafe unless-- reasonably be expected lo contribute (11 It and Its use or Intended use conform significant amounts of harmful additives publicized regulatory program against such products. Accordingly, the proposal explicitly states that there is no mora torium on food additive charges where migratory substances are found in pot tery dinnenvare, ename-hvare. or pewter. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 201(s>, 409. 701(a), 72 Slat. 1754-1788, 52 Stat, 1055-105G; 21 U.S.C. ..321 <s), 348, 371(a)), and under authority delegated to him (21 CFR 2.120), (he Commissioner proposes to amend 21 CFR Part 121 by adding a new $ 121.14, as follows: . ' to the terms of an exemption * pur at the final and. arguably, most critical 121.14 Food additive status of food- suant to subsection (l) (for investigational st3ge of food processing ii.e., immediately otilact urlieles intended for ii*c in ' use ( ; or ' (21 there Is In effect, and It and its use or Intended use are In conformity with, a regulation Issued under this section pre scribing the conditions under which such additive may be safely u'-ed. Section 409(b) provides that:. , (l) Any person may. with respect to any Intended use of a food additive, file with the . Secretary a petition proposing the Issuance of a regulation prescribing the conditions under which such additive may be safely "used. (2) Such petition shall contain-- * * ~ . (B) a statement of the conditions of the before being ingested by the consumer) at the very time when technological ad vancements have vastly improved meth ods of detection and evaluation of their effect in man. would be in direct conflict with the express mandate of section 409 (c)(5)(D) of the act. On January 17, 1974, Judge John Fcikens of the United States District Court for the Eastern District of Mich igan handed down an opinion in United Slates v. Articles of food pottery, holding that pottery dinnenvare is sub ject to the food additive and food re quirements of the act: t!ic household, fond service establish* nu'iits and food dispensing equip ment. (a) Any substance the intended use of which results or may reasonably be ex pected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food is subject to the food provisions of the Federal Food, Drug, and Cosmetic Act and, if it is not generally recognized as safe or exempt under section 201(s)(l)(4) of the act. to the food additive provi- sions of the act. This includes anv sub stance in food-contact articles whether -proposed use of such additive The legislative history leading to the Food intended for use in the household, food * ' (D) a description of practicable methods . for determining the quantity of such nd,-dltlve In or on food, and any substance formed iu or on food, because of Its use; Those sections are clear. They give no indication that some intended uses are to bo regulated wliilc others arc not. To Die contrary, they show a definite Congressional concern for additives in or on food regardless of how they got there. When Congress intended to exempt certain substances from the coverage of the act it had no difficulty making such Intent readily apparent. Thus, in sec tion 201 (s) of the act it specifically pro vided that the term "food additive" docs not include: (1) a pesticide chemical in or on n raw 'agricultural commodity; or (2) a pesticide chemical to the extent that It is Intended fur use or is ivexl In Additives Amendment of the Act shows a clear Congressional Intent that substances which are subject to being Ingested by human beings be cause of migration are "food additives" and thus ''foods" within the meaning of the Act. * * It Is likewise clear that ordinary packaging or food holding devices from which there is no migration are not subject to the Act. For these reasons, and in the interest of public health, the Commissioner of Food and Drugs has concluded that any prior statements by FDA which conflict with this notice arc erroneous ami con trary to tiio Congressional intent as plainly expressed in the act. and any such statements arc hereby withdrawn. The Commissioner recognizes that as a mailer of fairness, transitional provisions to implement this proposed regulation arc appropriate, since members of indus try may presently be marketing certain products bearing migratory substances service establishments, or food dispens ing equipment. <b) Except as provided in paragraphs (c) and (d) of this section, a food addi tive In a food-contact article intended for any of the uses referred to in paragraph (a) of this section shall, not later than December 31, 1974, be the subject of a food additive regulation or a food addi tive petition filed with the Food and Drug Administration covering such use. The filing of such a food additive petition shall slay the effective date of this sec tion until Uie petition is granted or de nied. (c) The transitional provisions in par agraph (b) of this section shall not apply lo: (1) Migratory substances in pottery dinnerwarc, enamchvarc. or pewter: (2) Any migrating substance which is a poisonous or deleterious substance under section 402(a) (1) of the act; or FEDERAL REGISTER, VOL. 39; NO. 72--FRI0AY, APRIL 12, 1974 PROPOSED RULES 132S7^ ( 'ood additives in food packaging and rapping materials used to package, hold, or otherwise contain food prior to ultimate purchase by the consumer. <d> Any oral or written opinions con trary to this section are hereby revoked and superseded. Interested persons may, on or before June . 1074, file with the Hearing Clerk. Food and Drug Administration, Rm. 0-8C, 5600 Fishers Lane, Rockville, MD 20852, written comments (preferably in quintuplicate) regarding this proposal. Com ments may be accompanied by a memo randum or brief in support thereof. Re ceived comments may be seen in the above office during working hours, Mon day through Fr iday. ' Dated: April 5,1074. ' . ` SamD. Fine, Associate Commissioner tor Compliance. |FR Doc.74-8424 Piled 4-ll-74;8:45 ami - DEPARTMENT OF : TRANSPORTATION National Highway Traffic Safety Administration [ 49 CFR Part 571 ] (Docket No. 74-16; Notice 1] .MOTOR VEHICLE SAFETY. STANDARDS Proposed Modification of Requirements for Motor-Driven Cycles This notice proposes amendments of 49 CFR 571.108. 571.122. and 571.123, Motor Vehicle Safety Standards Nos. 103, 122, and 123, that would modify current re quirements applicable to motor-driven cycles. The National Highway Traffic Safely Administration has been petitioned by Cycles Peugeot. Ateliers dc la Motobecane. and S.I.N.F.A.C. for "(l) recogni tion of the power-assisted bicycle as a separate category of motor vehicle and (2) promulgation of safety standards for the bicycle appropriate to its low power and speed." Similar petitions have been filed by Bermuda Bikes, Inc. and Robert F. Smith, who are retail dealers of lowpowered two-wheeled vehicles. These vehicles are currently classified as "motor-driven cycles", a subrategory of "motorcycle" that is defined by 49 CFR 571.3(b) as "a motorcycle with a motor that produces 5-brake horsepower or Ions". As such they are required to meet Federal motor vehicle safety standards, most importantly the ones covering lights (No. 108), hydraulic brake systems (No. 122) and controls and displays <No. 123). Petitioners contend that vehicles which produce no more than 1.5 horsepower de serve a separate classification, and that existing standards applicable to motordriven cycles arc not reasonable, prac ticable, and appropriate for them. This agency has decided not to estab lish a separate category of motor vehicle. Tho problems of conforming to the standards encountered by vehicles will) 1.5 horsepower or less do not appear to bo sufficiently different from those of vehicles .veen 1.5 and 5 horsepower to justify a separate category. However, this agency has reviewed the require ments applicable to motor-driven cycles in light of the petitions and the re newed public Interest In this type of ve hicle. and has found that certain minor modifications in the standards may ease the burden of compliance without jeop ardizing basic safety performance. With respect to Standard No. 108, this agency has tentatively determined that in view of the speed and weight charac teristics of motor-driven cycles, the problems associated with hand signaling and the lack of turn signal lamps are not as significant as they arc with the larger motorcycles. It is therefore pro posed that tho requirement for turn signals be deleted for motor-driven cycles with a top-speed capability of 30 mph or less. Also, it has been found that low-powered cycle motors may have some difficulty in providing the full re quired illumination. It is'proposed that the required stop-lamp photometric out put for low top-speed motor-driven cycles be reduced to one-half that for motorcycles generally. It should be noted that Standard 108 already contains re duced photometric output requirements for motor-driven cycle headlamps. Because of the low speed of these ve hicles, it appears that some modification of Standard No. 122, Motorcycle Brak ing, would be appropriate. Since fade recovery is not a safety-critical require ment for vehicles with low top speeds, it is proposed that a motorcycle be ex empted from the fade requirements of S5.4 if the speed it attains in 1 mile is 30 mi/h or less. Further, since Table I provides no maximum stopping distances below 30 mi/h, values for stops'from 25, 20, and 15 mi/h are proposed, maintain ing the same deceleration values as re quired of higher speed stops. For ex ample. a stop from 25 mi/h in the total system effectiveness test would have to be made in not more than 19 feet. Final!;*, the NIITSA is proposing an amendment to the Motorcycle Controls and Displays standard. No. 123. Manu facturers of lightweight motor-driven cycles have petitioned that placement of the rear brake control on the left handlebar, rather than at the right foot, be allowed. This deviation from tho standardized position for motorcycles would appear to have a minimal detri mental effect, and it is therefore pro posed by this notice. In consideration of the foregoing, it is proposed that 49 CFR Part 571 be amended as follows: 371.103 [Amended] 1. In 571.108 the following definition would be added to paragraph S3: "Speed attainable in 1 mile" moans the speed attainable by accelerating at maxi mum rate from a standing start for 1 mile on a level surface. 2. In 5 571.108 the following two sub- paragraphs would be added to paragraph SI: S-l.Ll.-_ A motor-driven cycle whose speed attainable in 1 mile is 30 ml/h or less need not be equipped with tunca signal lamps. S4.1.1._A motor-driven cycle whor-d3* speed attainable in 1 mile is 30 mi/h less may be equipped with a stop lanq whose photometric output for the groups of test points specified in Figure l is at least one-half of the minimum values set--j forth, in that figure. 571.122 [Amended] 3. In 5 571.122, the following scntcn.ce would be added to S5.4: "These require ments do not apply to a motorcycle whose speed attainable in 1 mile is 30 mi/h or less." 4. In 5 571.122, Table I . would be amended to add the following values: "Vehicle test Prclnirnlsh Frcliumlsh cflpctive* edecuve- ritecllye- ness speed ness pass total 71 illPS - total per lioyr system (5.2.1) partial mechanical svstems system (S.V4) CS5.7.I) lba.2.2) 9 I . 11 III (SS.-.ii IV IS.......... 13 30 20.......... 24 M 37 . 64 n l'J 30 Gx 571.123 [Amended] 5. In 5 571.123, Table I would be amended by revising Item 11,-Column 2, to read: "Right foot control.1 Left handlebar permissible for motor-driven cycles," Interested persons are invited to sub mit comments on the proposal. Com ments should refer to the docket number and be submitted to: Docket Section. Na tional Highway Traffic Safety Adminis tration, rvoom 5103, 400 Seventh Street. S\V., Washington, D.C. 20590. It is re quested but not required that 10 copies be submitted.' All comments received before the close of business on the comment closing date indicated below will be considered, and will be available for examination in !hc docket at the above address both before and after, that date. To tho extent pos sible, comments filed after the closing date will also be considered. However, the rulemaking action may proceed at any time after that dale, and comments re ceived after the closing date and too laic for consideration in regard to the action will be treated as suggestions for future rulemaking. The NHTSA will continue to file relevant material as it becomes avail able in the docket after the closing date, and it is recommended that interested persons continue to examine the docket for new material. . Comment closing date: May 13, 197-1. Proposed effective date: 30 days after publication of final rule in Federal Rxcister. (Sec. 103. 119, Pub. L. 89-503, 80 Slat. 718. 1.0 U.S.CJ. 1392, 1407; deloimlioun of uuthorltv nt 49 CFR 1.51 and 49 CFR 501.0.) Issued on April 9, 1974, Robert L. Carter, Associate Administrator, Motor Vehicle Programs. [FR Doc.74-0461 Filed 4-11-7-1:8:45 am} FEDERAL REGISTER, VOL. 39, NO. 72--FRIDAY, APRIL 12, 1974 M 9 8 t n f i 88 a n Al A 1 'V i ii ?! * i j i vsm RULES AND REGULATIONS 4 Title 29--Labor CHAPTER XVII--OCCUPATION *L SAFETY AND HEALTH ADMINISTRATION, DE PARTMENT OF . hUOR PART 1910-- : CCUPATION'AL SAFETY AND HEALTH STAUDM'DS 50 ppm, in wider to assess In a more definitive way whether that level of ex posure produces tumors m animals. Data reported by Torkelson, Oyen and Rowe (American Industrial Hygiene Associa tion J 22:354-361 <1261)) indicate that exposure to VC rt cov ventrations of 50 rary standard. In a tclegrnm to the As sistant'Secretary <', Labor, received on or ni-.-mt March 14, 1974, the President of th Unit, d Rubber Workers Interna tional .Inion urged the establishment of an em -gency temporary standard for VC, D !ng the hearing of February 15, Emergency Temporary Standard tor ppm failed to indue tumors in rats, 1974, : Industrial Union Department, Exposure to Vinyl Chlcr; hamsters, ralbii-s, anr. dogs. AFL-C'O, and the United Rubber Work 1. Back- our':. Vinyl chh.ihk. (chloro- eth ' ), Chemical Abri;.trLs Service Regi- try No. 75015, Is a synthetic chemi cal made by oxychlorination of ethylene or by h.vdrochlorination of acetylene. It is the parent compound of a series of thermoplastic resin polymers and co polymers which arc widely used for con tainers, wrapping tissues, electrical in sulation, pipe, conduit and a variety of other products. Vinyl chloride has been made commercinllv in this country since 1939 and present eduction is In excess of seven billion p. mds per year. Vinyl chloride (VC) is a rrs at am bient r "'rat'.':'- and pressure and Is a ihlnri::. ' .arbon which has mod- rrntoJIv' -. v. The present standard scis a col;::i:: vMue of 500 parts per million (ppm) (?,9 CFR 191U.93). On January 2T. 1974. the Occupational rvtlrly a'-.ri Hca'lli Administration was inlomvd by the National Institute for Occupational Safety and Health (NIOSH) l." at flu T. p. Goodrich Chem ical Company r<-: vied that deaths cf several of its em, .uyees from a rare form of liver cancer may h' been occupa tionally related. As a re of this notifi cation, and after cm itation with NIOSH and r joint in- ction of the plant by OSTIA. NIOSH. and the Ken tucky Department of Labor, a fact-find ing hearing on possible hr.-.ar, `nrolved with the manufacture and u: . of bath VC and polyvinyl chloride was an nounced on January 30, 1974 (3D FR 3674), and held on February 15, 2974. The employ. ;=> of the B. F. Goodrich Chemical Company who died from an giosarcoma of the liver had an average exposure of approxim ic-ly 19 years to vinvl chloride, at unknown concentra tions, and variable exposures to other volatile chemicals. (Tib 93). Some et- plovecs of Union Carbide Company and Goodyear Company arc also reported in a post-hearing comment from NIOSH dated March 11, 1974, to have had ex posure to vinyl o' 'oride and to have died from angiosarcoma of the liver. Finally, autopsies of four deceased employees re vealed that liver angiosarcoma tumors were histologi caTIn distiii guisliable from the angiosarr m tumors observed in Professor Maitoni. experimental ani mals. It Is concluded therefore, that vinyl chloride Is carci; .>gcnlc for hu mans. We therefore conclude that the prese. standard for VC should be lowered fro:, a ceiling of 50' ppm to a ceiling of 50 ppm for the following reasons; (a) In light of the evidence referred to above including the Multoni experi ments demonstrating that VC is cm inorenic in animals at 250 ppm, we c.o; lude fiat VC must be considered carcino genic in man at the same level; (b) Although Professor MrJtoni do' not Induce tumors In his experiment-1 animals at an exposure concentration of 50 ppm, these data do not support the concept that occupational exposure of employees to concentrations of 50 ppm throughout their working lifetime wcui' be without detrimental health effects; ers International Union made a joint petition for an emergency temporary standard for VC (TR M2-24S), vchirii was also joined by the Oil. Chemical and Atomic Workers International Union (TR 37). At the same hearing, several participants urged, on the other hand, a regular rulemaking proceed ng as the most suitable for t'xc orderly develop ment of relevant iiiforrr.nl'cn (TR 112 180), The petitions for an c; -Tgency tem porary standard specified in detail thc- contents of the standard re. -sied. In. substance, the request Is, to issue a com prehensive fully-developed standard based on the recommendations cf she Standards Advisory Committee on Car cinogens submitted to Die Assistant Se:- retary of Labor on or about August 27. 1973. The rco^mmonda'ier.s are far- ranging, and cover special categories of operations, signs and labels, medical sur veillance. reporting, clc., including a per mit system for the use cf a carcinogen. We Agree that an e: -gcncy tempo rary standard is neco: we cannot say on the basis of the :c ho .Aon developed so far Hint a compre;,?-nrlve standard, such as the one i equer-ted. Is either neces sary or eve desirable. It has been de cided lo promulgate a standa: eon*. "- ir.g only tliose esacntirl prevhtens v h are deemed necessary t.o provide proAc- tinn to employe a:: from grave dang/.r until a regular rulemaking proceeding In accordance with sections 6 <b) and (c) of th? Act can be concluded. The rea sons for a decision to establish a celiin.7 2. Carcinogenicity of VC. Information (c) The question whether safe levels value of 50 ppm have already been produced at the hearing demonstrated of exposure lo carcinogens exist for hu stated. A decision or. other poisible, ap that exposur of laboratory animals mans and, if so, what such levels would propriate provk.ons ir- bf-.st made after (mostly Sprague-Dawley rats) to VC by be, is the subject of continuing sc>.;ntific consideration of all relevant data and Inhalation at and below the current deliberation. In the case of VC. Profes views that Interested ptrsons may sub OSHA standard of 500 ppm induced sor Maltor.l aid riot observe tunic; a In mit during the proceeding soon to tc tumors. Including angle; arcomas ol the his animals at exposure concentrations initiated. liver. Professor Ccxarc . :Jtoni, of the of 50 ppm. In addition, Torkclson, Oycn, With respect to argumets in opperi- Institute di Oncologia, Bologna, Italy, re and Rowe found that exposure to con tion to issuance of an emergency tem ported on a series of experiments on the centration;; of 50 ppm of VC failed to in porary standard, the concern and ef<-> effect of exposure of rats. mice, and duce tumors in rats, hamsters, rabbits, of aevc ml companies pori icipatins at the hamsters to VC at concentrations of 10,-- and dogs. According!}*, there is insuf hearing' for the protection of their em 000; 6,000; 2,500; 500; 250; and 50 ppm ficient evidence at this time to conclude ployees are recognised, li may alco be for varyiiig periods of time (TR 43-13). that VC at concentrations of 50 ppm or that some employers in rrvne plants have Some of the experiments have been con below poses a grave danger to humans. fully complied with tkv interim control! cluded. and others re still ongoing. The (d> The emergency temporary stand recommended by NiO.SH on January 3C. experimental result:: so far reported are ard adopted represents a substantial re 2 974. There is, however, reason lo believe that tumors have been observed In duction in the permissible level of expo that employees are curr-wNy being ex groups of animals exposed to VC at con sure and, in our practical judgment., is posed to VC at cor-ccnf rm i,,>r.s well ;-*?ov centrations as low as 250 ppm. No tumors the lowest level that can be complied 50 ppm. This was :evened rover:-} tarn have been observed in the group of ani with immediately; and at the hearing, and net v/isly q."..- mals exposed to VC at a tuuu*.-;:uation (e) This standard 'All be in effect for liunc-u. Mi/i'eoVr. i.'oort, dated Marc . of 50 ppm. It also appears so far that a period of no longer than fix months, 1974, of a survey by ihc xtr.T cf the OT;' the total number of tumors, as well as during which rime the whole question of of Standards 1-. volo;:;u.?nt, OSHA. c. the numbers of angiosarcomas of the possible safe exposure of humans to VC several facilities n.anuiaoturing VC r.-; liver, decrease as the concentrations of will be reconmdi'red more fully and In. pclj-vdiijl chloride rcve,'',d conecndrr VC are reduced to 250 ppm. Vitmlly, t.he light of more information, including tions for some job e!:.:uriica`hOfA (.'> h.. another experiment by Profess. Mut experiments which ore under way at this as 22D ppm. Tlwr.; r. rcyiuatlca ton! Is undi -v.'uy involving the c. osure time (TR 47, 49, 71-74). considered necessary to utovide, Inu-..,' of 300 animals to VC at c-oncenlrMions of 3. Pcfa'fonf for an cvicracncv fcJ/tpo- ately, adequate i>Kt<rehr;; lo FEDERAL REG' STE^, VOL. 3 9, NO, 67--FRIDAY, APRIL 5, 1974*1 4 VRD 000280768+ .. ''V. ^ RULE REGULATIONS A 12&3 }.soti i;> VC.'Also, the eight-hour, tinie- Secretary of Lab.ir's Order No. 12-71 (36 (4) Employee observation of monitor vreighk i -v rage rt gr.-jurd suggested by FR. 37 6-1). 29 Ci It Part 1910 is amended ing. Employees working in an area or several p:. ipantr; at the hearing (see, by adding thereto a new $ 1910.93q to operation whose ambient air is moni for Ir.r.t . Tit l-va), lias been rejected. read as set forth below. In addition, pur tored, or their representatives, shall be The y ; a 1974 report of the survey re- suant to section 4(b)(2) of '.he Act (64 ptven a n .usonable opportunity to observe vealc- 1 several kinds of work or op Stat. ibrrvi; (22 n.s.C. 653)1, the stand the personnel monitoring required by erate . -.Ci (' short duration. Loading ard in the new 191Q.93q is determined this section. or u- ..in of a tank car may require to be more effective than the corre (5) Rccordlwcping. The results of rvli ape tely 15 minutes. The ch nag sponding standards now in Subpart B of monitor;!:." yhall be recorded in writing. ol xtor may require approximately Part 1910, in Part* 1C15, 1916. 19W, 1915. The recoi ds shall t>e retain yd for at lc;:.' t h- iui hour. An eight-hour, time- and 1926 of title 29, Code of Federal Reg 5 years and shall be mar available fc.r w;.-.;htcd average standard would permit ulations, and in Part 50-204 of Title 41 of irL^pcclion nud copying b. representa exposure to VC at concentrations of 400 the Code of Federal Regulations. There tives of the Assistant Secretary of Labor p; ~i for one hour. Such upward excur fore, thes* corresponding standards are for Occupation.d Safety and Health sions, several limes the r.O 1 - >m level, can superseded by the new standard in ar. the Director of the Rational Insti not be permitted to - ' t. $ 1910.93q. tute for Occupational Saiety and Health 4. Ae standard. 7,; standard set out 1. In'29 CPU Part 1910. 1910.93 is (NIOSHL - below contains only tne requirements amended by deleting from Table G-l the (6) Employee access. Each employee deemed necessary to provide protection line; "* * C Vinyl chloride * *,* 560 and former employee shall have acce;:, to before the conclusion of Uu. rulemaking 1300". *'.. such records of the results of monitor; z . proce*-di to be commenced shortly. 2. Part 1910 of Title 29 of the Code required by this section r.s will indicate Becau exposure to VC is hazardous, of Federal Regulations is amended by his own exposure to airborne con.. ra ?: d became such exposure can occur in adding thereto a new g 1910.93q to read, tions of vinyl chloride. the processes o` synthesizing or polym as follows: , ` 0 (7) Employee notification. Each em erizing of VC or in the handling of VC polymoi copolymers which contain 19I0.93({ Vinjl chloride. ployer shall promptly notify any em ployee who has been or is being exposed ah' -i t-hig standard applies to all (a) Scope cuid replication. (1) This to vinyl chloride in concentrations in ex- sue' ..ses and to the handling, re section applies to any area or oi>era.'cn r \ of 50 pp:u, and shall ir` '.-rn him of act aDUlacturiny. processing, re leasing, . ^packaging, or storage of any of in which vinyl clilonde tchloroethenc), Chemical Abstracts Service Registry tl:-.-corrective action boirgu. (d) Compliance. tl> V. :ievcr any the.se materials. .The monitorin', require- Number 75015, is manufactured, reacted, monitoring san -lie reveal- ] chloride v ;.nts s- 've two purposes, to trigger into' 'orati-.. a compliance program . ' to handled. processed, or stored. released, ` repacked,' at a concentration in excess of 50 ppm, or whenever any accident, such as rup . :eck t' . onectivene..ss of the pr m. (2) This scion does not'apply to the ture of equipment or spillage, indicates Also, enoh-e'.-ring contj-ols are fav... i tor handling, stc; >, or other u~e of vinyl the likelihood of a greater than usual compliance, and rcspii-ators are intended chloride polymers and copolyn*fcrs in the release ol vinyl chloride into the ambient to provide protection until such controls Iv'.-rn of fabricated products. air. all employees exposed to such con- can be installed or n. cases where such (b) Permissible < gposure. Tne occupa- ccn.tr-lions shall be withdraw n to a rate controls are no- feasible. tional environment shall be controlled so area nnd shall not !>e pen-.' ^.d to re Accordingly, reason of the foregoing and on the b: .s of the record of the hearing of February 15, 1974. v.h- ex hibits, the written submissions received that no employee is exposed to vinyl chloride at a concentration In excess of 50 parts per million (ppiu) (127.0 . mg/cum 1. enter the work area nr lea.- uey wear eitlier Type C conti'.'-- -<r fiow or pres sure demand air sir .wd respirators or self-contained breati. ng apparatus. hi. ore the hearing pursuant to the notice (c> Monitoring--(1) Initial monitor (2) Work which rnav reasonably be . of the hearing, the post-hearing written ing. As soon as possible but not later than expected to release vinyl chloride in con submissions by the participants at the April 22. 1974, every employer o' an em centrations in excess of 60 ppm, such as hearing, the March 197 i report of a fact- finding so rvey recommc ndalions received ployee working in an area or operation in which vinyl chloride is manufactured, re repair, maintenance or cleaning of re actors or oilier equipment containing' from NIC-SH. and the o'her data referred acted, handled, processed, released, re vinyl chic me, shall be accomplished only to herein, it is found < 11 that VC at con packed, or stored shall begin monitoring by employees wearing T.. t.i C continuous centrations in excess of 50 ppm is pliysi- the ambient air of the area to determine flow or pressure demand air supplied res vlly harrnf and carcinogenic: (2> that whether it contains vinyl chloride in con pirators or aolf-contained bi eathing ap c xivosure to VC at concentrations in ex centrations in excess of 50 ) m. paratus. cess of a concentration ol 50 ppm poses a (2) Frequency. Monitor. of a suiS- <3) In any case covered by para grave danger to employees; <3> that em cicnt number of ere >!oye, so that o graphs (d)(1) or (d)(2) of this section, ployees are presently exposed to VC at represeni -ive sample of ev.posurea to in addition to providing the required concentrations in excess of 50 ppm; and vinyl chloride may he determined shall respirators, the employer ahall exarnme (4) that the emergency temporary stand be accomplished not less frequently ilian and analyze the iourcc of the oxc: sive ard sot out below is necessary to provide Immediate protection to employees from sm ; danger. .rsuant to section C(e> of the Ocoup;...ural Safety and Health Act of 1970, a proceeding will commence shortly In accordance with section 6(b) of the Act. In which the emergency temporary standard will serve as c. proposed.rule, together with other rubcidiary rules. Ar, " soon as possible - ''raft cnvirouijienuu impact- statemen'. U be filed with the F: Wildcat's Co.ir .i on Environmental Quality, and copies will be provided to other appropriate Federal agencies for their cc nents. Pursui-.nl to sections C(c) and 6(c) (3) of the Willlan-iS-St-elgcr Occupational weekly until all results for three com :-cutive weeks arc at or below 50 ppm. There after, monitoring shall be conducted not loss frequently than monthly so long as the concentrations of vinyl chloride do not exceed 50 ppm. If a monitoring sam ple reveals vinyl chloride in concentra tions in excess of 50 ppm. weekly moni toring shall bo resumed until all results for three consecutive weeks are at or betow 50 ppm. (3) Method of mcr.il.orini/. Personnel monitoring shall be ncecr.p] idled l>y col lecting samples by f-viiahle btuceaVom by the employee. The samples .dudl he analyzed by gas cim-n ut-orrephy or by any other method who i is of c-VJhalcnt sensitivity. Tlio am.Miral procednc Khi-11 be sensitive to 5 ; -; m of vinyl thbv- concentrations of vinyl chloride in order to determine feasible enium-cring or op erational controls appropriate to reduce the airborne couceiAraliotis to the permissoble level. Such controls sliaJl be implcmentcrl as quickly a? pocr.ible. (4) Periodic tests shall be conducted for equipment leaks and for eniimions of vinyl chloride which may re:uit from work practices. 3. In 29 CFR Part 1510. 5 1910.19 L revised to read os follows: 1910.19 Sji iul pruw.-imu* for air ron- laoiiiiiiiit'i. (a) Asbestos dust. Section lSJO.JKia shall ai>])ly to the ex;>osure of cve.ry em ployee to asbestos dust in every ci '.r.ioyment and place of employment i vored 5afet7 and Health Act of 1970 (84 Slat. ride In air with an accuracy of d:20 per by 5 1910.12, 5 1510.13, 11510.14, 1500, 1599; (29 U.S.C. 655, 657)), and cent for a ten r.iinui nr sample. 5 1910.15, dr 51910.16, in lieu rI any dif- Ko. C7 Ft. I- fEDERAL REGISTER, VOt. 39, NO. 67--TRIOAf, APRIL 5, 1974 VRD 000 200 76 05 mn RULFS *ND. REGULATIC ; .rent standard ( . c\ ...sure to asbestos cIu.nI, V.-Idch otherwise be appli cable by vin... ,.f any of those sections. (b) vr:v: - .. Zor-Wc. Section 1910.93q shall the exposure of every em ployee tc "ih.v'i chloride in every emplo;. - m-i.-t nr. place of emplovrv: nt covered by 5 If . 12. {1910.13. {1910.14, { 1910.15, * 1910.16, in lieu of any dif ferent st . .ard on exposure to vinyl chloride v/nich would otherwise be ap- i able l .v virtue of any of those sect ; ;!ccii`^e date. These amendment: sk il l - -.me effective on .'.pril 5. 1974. (Sees. 4. . :.JKl 8, B4 Stftt. 16?>2, 1506, 16C-r> (20 U.SC. ccj, 665, 067); Secretary ot Labor's Order No. 12-71, 36 FR 7' '.) Signed at Washlr. n, DC., this 2d day of April 1074. John Stender, Assistant Secretary of Lobor. _ [FT. Doc.74--70SO 3 ..od 4-4-74;8:45 r-rn} Title 32A-- National Defense, Appendix CHAPTER X--OFFICE C r OIL AND GAS, DEPARTMENT OF 1. INTERIOR {Oil Import Reg. \ <R*' , Amd:. 65] Federal mandatory crude allocation pro gram In its present form. The Federal Energy Office has now proposed changes to that program. For these reasons it has been decided to retain the historical br-sis for making allocation eff Cnru-dian imports into Districts I-1V. 'Hie r.p.r change is a provision that re<iuircs ,f, r. . person having an allocation of Canudhui imports must piocess the entire volume of Canadian imports in his own facility. The changes to section 33 are strictly technical in nature with the exception of the liccnsi; ; pe>-' -ds referred to above. This am- ndment also amends section 3 to provide that entries for consumption of c.-.nadian imports by pipeline under a li>--Issued pursuant to the.- regula tions may be made until midnight cf May 15, following the end of the allo cation period In which the license au thorizing such imports from r .nada was issued. Tills fifteen dry over; is neces sary to prevent disruption of pJjndine operations at U .- end of each allocation period. This amendment 65 becomes effective on April.5,1974. William A. Vocelv, Acting Deputy Assistant . Secretary of the Interior, entries for rnrvvmptic/.' ' Canadian Im ports by pk . may be n.'-.tle until mid night of MIf. following expiration of the allocuon period in which a license authorizing such imp .ts from Canada was Issued. Section 29 is amended in its entirety to read as follows: , See. 29. Canadian Imports--Districts I- (a) As used in thi- section, the term "Canadian imports" means imports from Canada of crude oil which has been pro duced in Canada and unfinished oils which have been domed from crude oil or natural gas proouec-d In Canada and which have been tra;.:,-oru-d info the United States by overland means or over waterways other than ocean waterways. (b) To be eligible for an allocation of Imports under tills section, a pernon must have in Districts I-IV a facility capable of processing Canadian imports. (c) The Director shall, in accordance whh the terms of paragraph of tl section, make allocations for the al- location period May 1, 1574 thrown April 30, 1975 of not to exceed 762,050 average barrels daily of Canadian im ports into Districs I--IV. OIL IMPORT REG. 1---nlL IMPORT REGULATIONS Canadian Imports l'1''.re appear ' In the Federal Rroistv . on Ft-bru. ' 1, 1974 (39 Fit 5153) a ]>: oposal to c. J several sections of OU Import Regui-iion 1 (Revision 5 , as amended. Amendment 64 to Oil In. rt Recrulation 1 (Revision 5) made The ch: r es related to the-prop^ec! rulemakinr, ' t all sections except- for sections 29 auci 33. both of which pertain to Ca nadian imports. Publication of amend ment of sections 29 and 33 was deferred until discussions could be held with the Canadian, government to determine their export policy. Those discussions have been concluded. The Cantuean govern ment plans to continue to control ex Approved '. William E. Simon, Deputy Secretary of the Treasury. A new paragraph (f) is added to sec tion 3 to read as follows; Sec, 3. Allocation periods. (f) Notwithstanding the prov' -,s of paragraphs (a) and (c) of this . ection Sum of each eligible applicant' allocation of Canadian Imports In 1&73 par: nt. to sec tion 23 and se-Uion 21-exyrcsic--. in barrels per day Sum ol all allocations of Canadian Imports in. 1973 pursuant to taw'on 23 and Ee-tron 21 -expressed in barrels 1 `day , (d' -"'> The Director shall make al- locat- : not subject m license fees of Cant .;n imports to eligible applicants who received allocations of such Imports for the period January 1. 1573 through December 31, 1973, purr;; nt to section 23 or from the Oil Imp-:, - '.3 Board under sec-lion 21. or from i>jih. <:aeh such applicant- shed. be entitled to nr. alloca- tl: 1 of Car,u.vn imperi.*: calculated in accordance with the following formula: X 762,OC .crrels/day ports along the lines of their present controls for at least through September 1974 at which time the method of con trol may be modified significantly. Ac cordingly. interested parties should note that, although sections t'f1 and 33 sirewritten to prcrvjde allow;1- ns for the entire allocation period l y 1, 1974 through April 30. 1975, lmcs. os will ov` ' be issued b.hinny for one half of the May 1. 1974 through April 30, 1975 al location period and the license.'; will only lie valid for a six month pm-jod unices extended by the Director. Tin h procedure 'wi.I provide for needed Cc-xiPility should the Canadian export ]>oHcy change to the ex ton t that It is ni-.-'-'w-j1 to further (2) The Director shall issue before May 1, 1974 to each eligible applicant a license equal to one half of the allocation calculated pursuant to subparagraph (1) of this paragraph. Such licenses shall ex pire on October 31, 1974 unless extended by the Director. The Director shall issue before November l, 1974 a ;econd license to each eligible applican' equal -o the remainder of the allocation c: .dated pursuant 'to subparagraph (1> --f th paragraph. Such licenses shall expire 0.. April 30,1575. 1 (e) (1) Except as prov:-' d for ir sub- paragraph (2) of this pa err.uh per son who imports Canadian imports mu: t or unfinished oil received in his 0 n facilities. Settlements, credits, monetary, or accounting adjustments reflecting th.e relative values of the oils involved in the exchange are penn:.- sidle . (ii) Canadian imporis which arc sold to meet the requirem-mus of rc-gulaticns published by the Federal Energy Oiuce shall not be subject to the provisions of paragraph (e) of this section. (f) If a person who rccc-iu-s an alloca tion of Canadian imp:., ts r-nd .r h Is sec tion fails to Import me tof;l quantity of imports specified In the uh-.-eatto:;. or if he fads to process all such imporls ;r: Canadian imports rcocr ed ;:i oxcl-a:. :c fr,r snr-i Irry- :-,) )'*, ni1- fr-Uities lu- Import Regulation Lo conform to such changes. 'As stated in the preamble to Amend ment 64 tbo three tier system pro./OoCd for making allocations under section 29 did not receive complete acceptance. Also, the proposed change to section 25 was predicated on a coiu_nuution of tlu- ity. For the purpose of this par.a -v.ph. blending by mechanical means docs not constitute processing. (2><i) Canadian Imports may be ex changed w, a barrel for Ivne! ba.-.is for 0`he-r Cn 7ir.it imports but each person receiving crude oil or ur.finiaix u oils in the'cxcliaii;': must jnoc'.i;; the crude oil fore July 1, 1975. or if be fail;, to inc..t the requirement of paragraph to) rf this section, then any alloc a^on of Conadirm imports for Districts I-IV lo which such person may othwwiso he cnti'lcd for t..e first allocation period bv, !:iiur.,v after April 30, 1975 shall be reduced by the Di rector by the Amount of Canadian 1m- FEOERAL EIGISTtP, VOL 39, NO. 67--FPirAr, APRIL 5, 1974 9-84.1X0-1.8 UNITER STAT ENV1R0NMT iTAt. FROTEC. ON AGENCY W, - Hlf- <5TOH, D.C. 0^0 OFFICIAL BUSINESS PENALTY r 3 PRIVATE USE !S00 AN EQUAL O!-'r-O KTUN IT Y EMPLOYER POSTAGE AND FEti PAID U!. CNVIRONMENTik PROTECTION ACFNCY EPA-3 JS O . a rV'1'-- -J - "S'. .&***-. *"v '*-~-*~*>*rs '71/'7v ,;r : t* ,;:! T\ V* v:;.-j \ t U 'r'*'" ' " W" ? ./ .V O'Neill (202) 755-C344 Farkas (202) 755-7^0 FOR IMMEDIATE REI/:ASE THURSDAY , APRIL 4/ 1974 EPA FORMS VINYL CHI-^RIDS TASK FORCE The Environmental Protection Agency has f armed an internal task force to assess the overall environmental impact of vinyl chlo:ide, a gcseous chemical, and the plastic, polyvinyl chloride. Vinyl chloride has been implicated in the recently reported deaths of ten worker's at plants where the gas is used to produce the polyvinyl chloride. All died from a rare form of cancer, called angiosarcoma of the liver. The task force, chaired by Glenn E. Schweitz: Director of EPA's Office of Toxic Substam as, is charg'd with assessing possible- environmental and health risks associated with the manufacture, distribution, and disposal of vinyi chloride and polyvinyl chloride. At present, the task force is reviewing, collecting and assessing data on 1) the ambient emission and effluent levels of vinyl chloride in air and water from vinyl chloride and polyvinyl chloride manufacturing plants 2) the environmental impact of all disposal methods for v-f^yl chloride and polyvinyl uautiae wastes, including landfill, incineration, deep-well injection, and ocean dumping 3) ecological effects of vinyl chloride in the environment. The task force plans to meet with environmental and consumer groups to discuss its mission and exchange information. A similar meeting has taken, place between the task for: e and the chemical industry. The task force is also working with other Federal (more) Return th - h#*t If you do NOT with to receive this material [j. or l( ehanga erf ado. EPA FOk TftlO.1 (REV. 6-721 Is needed Q (Inditata chan*;-?, deluding zip coos). VKD 0002007607 V -2- agencies concerned with vinyl chloride, induing the Department of Labor? the Department of Health, Education and Welfare; the Conr-.uner Product Safety Commission, and the Department of Commerce. Vinyl chloride is used as a propellant in 23 pesticide aerosols currently registered by EPA. The gas helps expel the contents from the pesticide containers. In a March 28 letter to the Health Research Group, a Washingt D.C. bar.ed public interest organization, EPA said that it will shortly notify the manufacturers, formulators and distributors ot these products of the need to substitute another substance for vinyl chloride. A copy of the letter is attache The Agency said that, "Even though the health data for vinyl chic ide are limited, we believe that it is prudent public policy for us oto request the manufacturers of these pesticides to make a voluntary change..." If a currently ongoing EPA evaluation of these pesticide:, indicates a substantial r:`sk or imminent hazard to the user, and if voluntary compliance has not been obtained, the Agency will invoke suspension of the products or other enforceable remedies. On March 27, EPA mailed letters to the manufacturers giving them ten days in mhich to state any objections to the Agency's making public the brand names of the 23 products. This period for coitctk nt is required since the existence of vinyl chloride in the pesticides may be considered part of the products' confidential fc `iulation3. ### 809tB 0i0B 0 OHA % .* *<!> i.C ` K 'il.i.vMj 1J ULlKJM.. bl.-.vl TO " A1 b `,'1 M/l-XCAL AOt C >.0 5 ' .t K o h u s L b bfVV / rr < hr.LAT 1 10 - 1S-.i'lrt. 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I i 00/ h ' i ) \ b / ,,>1 / V ~ b ; ` s V J/ / a .> * t / r.U.VL / b'l< 1 / (<'/ ~ 1 Y y h ri./i V ** " r1? 0 76 16 Editor: Louis Rothschild, Jr. Managing Editor: Raymond Gaiant Assistant to the Editor: Natalie Pargas Assistant Editor: Eileen Kug/er Circulation Director: Shirley Gaiant Production Manager: Dorothy Hiif Associate Editors: Cathy Cooper, Gail Tapscott FDA REGULATION OF INDIRECT ADDITIVES TO BE REAPPRAISED The Food and Drug Administration is embarking upon a reappraisal of the basic "assumptions" that underlie its regulation of indirect additives, it was disclosed at a March 25 meeting of the agency's National Food Advisory Committee. The new look at indirect additives -- particularly packaging materials -- was prompted by: (1) unexpected migration problems with acrylonitrile-styrene-butadiene plastic bottles for soft drinks, which may delay use of plastic pop bottles for some time; and (2) possible vinyl chloride monomer migration into food products from rigid polyvinyl chloride containers (See FOOD CHEMICAL NEWS, March 18, Page 23). Packaging Labor ;Qry Established in Bureau of Foods Richard Ronk, who is director of food and color additive work in the Bureau of Foods, disclosed that the Bureau has established a Packaging Laboratory to provide guid ance in determining whether the system FDA has used for years in regulating in direct additives is satisfactory. Ronk said that if the present "assumptions" do not prove out, FDA will have to develop a new method of evaluating indirect additives. If, however, the reap praisal indicates that there is no problem, "there are things we shouldn't be doing, " he said. The FDA-er explained that if there are no problems, the agency is spending too much time and money regulating indirect additives, such as adhesives components. "We're not convinced that the system doesn't work," Ronk stressed. Bureau of Foods Director Dr. Virgil O. Wodicka , confessing to long-term "concern" about indirect additives, said no hazard has been known so far "because of the extent of our ignorance. " He commented that this is true despite the fact that the United States has more stringent regulation of indirect additives than any other nation, Wodicka said, "... There are still many problems . . . and many decisions to be made." Saying that indirect additives comprise "a very complicated area," Ronk said regulation of more than 10,000 indirect additives has been based on "a series of Page 4 April 1, 197 FOOD CHEMICAL NEWS assumptions. " For example, he said FDA has relied on use of food-simulating solvents -- distilled water, 3% acetic acid, aqueous ethyl alcohol up to 50%, and heptane . The agency has required extraction in these solvents at 120 F. until equilibrium is reached. Another assumption, Ronk said, was that the total diet consists of 80% aqueous food, 5% acid food, 5% alcoholic food, and 10% fatty -food. "In its time, this was a good system,'1 the FDA-er said, announcing the intention to reappraise the assumptions. However, he noted that there are problems with equilibrium studies, since migration has been detected long after equilibrium was believed to have been reached. Noting the possible need to "evolve a system, " Ronk said that if migrants have to be determined in foods rather than in food-simulating solvents, it will be a "fantastic analytical job." Wodicka suggested that some of the unexpected migrants found after the equilibrium has been reached might result from de-polymerization on aging. Wodicka said that he has regarded the review of "generally recognized as safe" substances as an "administrative tidying up of the files," because he expected few problems to arise. However, he expressed doubt about indirect additives, because of the nature of the "foreign" substances and lack of knowledge as to whether the human body possesses enzymes to handle them. The Bureau Chief added that there is a possibility that a no-effect level modified by a safety factor may be "scientifically naive" in evaluating indirect additives. Wodicka said that FDA is now considering a way to review approved indirect additives. Acrylonitrile Extractives Found After Six Months Making the first public disclosure of the acrylonitrile problem, Ronk said that extractables have been found after six months, despite a much earlier equilibrium. Noting that the firm involved will bring in more data, he said that if there is extraction long after equilibrium was thought to be reached, "all of this will have to be held in abeyance." He said a no-effect level of .5 p.p.m. doesn't leave a sufficient margin of safety. Tests by the company indicated residues from migration ranged from 0.3 to 0.5 p.p.m., under the most severe conditions of the study. Ronk noted the significant economic impact, saying that a number of firms are working on acrylonitrile bottles for soft drinks. He said one clearance has been granted on a Food Additive Petition filed by Standard Oil of Ohio. All of the companies have been notified of the need for new tests on migration, and there is some belief that new work may near completion by one of the six firms consider ing marketing acrylonitrile bottles . The FDA-er hailed the acrylonitrile bottle as a "breakthrough in technology," but discussed the residue problem, including possible cyanide residues. Ronk concluded, "I'm sure they will solve the problem." April l 1,974 Page 5 FOOD CHEMICAL NEWS VRD 0002007618 Interim Food Additive Order for PVC Would Set Limits , Regarding the PVC problem, Ronk said an "interim" Food Additive Order might be proposed to limit vinyl chloride to less than 10 p.p.m. in rigid plastic, with a limit in an end test of 50 p.p.b. For PVC films, the limit would be 1 p.p.m. in the film, with an end test limit of 50 p.p.b. The FDA-er said that if all of the vinyl chloride monomer migrated, the total would be less than 50 p.p.b. He also indicated FDA may require establishment of a no-effect level. Wodicka noted that no interim Order proposal has yet been reviewed at the top levels of his agency. Ronk reviewed tests made on PVC extracted in heptane for organotin stabilizers, saying it was "too bad" researchers did not look for vinyl chloride monomer at the same time. He said there was a "significant amount of extractives" of organotin stabilizer, and that a small amount of the stabilizer -- 0.06 p.p.m. -- was still extracting after 14 months in cottonseed oil at 135 F. Ronk indicated this may be predictive of vinyl chloride monomer extraction. The FDA official said a 1971 Italian study using inhalation indicated that vinyl chloride might be a carcinogen, noting that another Italian study is now underway attempting to reproduce the 1971 results. Carcinogenicity has not been established through ingestion, Wodicka noted. Statistical Model Could be Used For Methods For Carcinogen If vinyl chloride proves to be a carcinogen, Ronk said, methodology will have to be developed. Wodicka said the problem would then be one of enforcing "zero." He indicated that, if it were necessary, FDA might use the Mantel-Bryant statistical model, or some variation of it, to determine the needed sensitivity of method to i. demonstrate no residues of a carcinogen. FDA proposed adoption of a variation of the Mantel-Bryant method for feed additives , and it was indicated last week that it might be applied to the controversial case of diethylstilbestrol (See story. Page 6).. Ronk said British data indicate that vinyl chloride can migrate to a fatty food, and that it was also shown to migrate to an aqueous fruit drink. He added that any PVC problem is probably limited to "rigid formulations, " and noted that the Society of the Plastics Industry has indicated that migration can be reduced through use of new formulations. He added that in the Italian test, 250 p.p.m. was reported as the lowest no-effect level. Wodicka raised the question of FDA authority to regulate a finished formulation, noting that the agency has authority to regulate ingredients (food additives). Ronk replied that FDA can prescribe safe conditions of use. Page 6 April 1, I97yl FOOD CHEMICAL NEWS * The Bureau Director noted that FDA's limit of polychlorinated biphenyls in paper and paperboard has been stayed, and that the agency's authority to regulate paper has been questioned (See FOOD CHEMICAL NEWS, Feb. 11, Page 22), Wodicka said the outcome of the PCB matter may affect FDA's position on PVC containers. Ronk prc icted that FDA will be "more aggressive" in regulating indirect additives as a result of the knocking out of the old "housewares exemption" (See FOOD CHEMICAL NEWS, Dec. 3, Page 3). He disclosed that FDA's long-pending proposal to issue a Food Additive Order for synthetic organic colorants in paper and paperboard (See FOOD CHEMICAL NEWS, July 12, 1972, Page 18) has gone back to the drawing board. He said the agency has found that the end-test specified in the proposal does not work. Ronk com mented that FDA is now "back to ground zero" on the colorants proposal, and will probably have to work out a listing of approved colorants. 0 MANTEL-BRYAN APPROACH MAY BE APPLIED TO DES METHOD The Food and Drug Administration will ask an ad hoc adivsory group of experts to study the sensitivity of analytical method which would be needed for the continued marketing of diethylstilbestrol. The deliberations of the group will be based on FDA's controversial proposal under which the sensitivity of analytical methods for carcinogenic animal drugs and other feed additives may be extrapolated from the results of toxicity studies (See FOOD CHEMICAL NEWS, July 23, Page 22). The FDA proposal is a variation of the MantelBryan statistical model, The question of the needed sensitivity of a method for DES became especially pertinent last week with the March 27 FDA proposal to revoke the official status of currently-used methods, as expected (See FOOD CHEMICAL NEWS, March 25, Page 19). At'the same time, FDA urged use of a 14-day withdrawal period rather than a 7-day withdrawal period for DES-medicated feed. Under the Delaney anti-cancer clause, as it applies to veterinary drugs, a car cinogen may be used only if no residues are left in human food when tested by an officially-approved analytical method, The proposal last week to revoke the of ficial status of the mouse uterine method would leave DES with no place to go in a regulatory sense. Recommendation by the ad hoc group of a required sensitivity of method would pre pare the groundwork for adoption of a new official method which could retain use of DES. Plans for the ad hoc committee and use of the Mantel-Bryan approach was disclosed March 26 at a meeting of FDA's National Food Advisory Committee by Dr. C. D. Van Houweling, director of FDA's Bureau of Veterinary Medicine. He said he 50 O <S5 S ro CS ess .siUBiitu a rt f* /'Tb 0vupM| 1 <*.: v mi,! Health Av niulratlon Barr (202) 961-3914'' (Home) (703) 354-0199 FOR. RILHASE: IMMEDIATE Friday, March 22, 1974 V QSHA ANNOUNCES EldEROENCY MEASURES TO RROTSCT YORKERS FROM VINYL CHLORIDE v The Department of Labor announced today it will issue an emergency temporary healt' standard to protect workers exposed to vinyl chloride while it proceeds with normal . y i . ,, rulemaking procedures for a permanent standard. .. distant Secretary of Labor John H. Stender, head of the.Occupational Safety and Health Administration (OSHA), said the emergency standard will reduce permissible t <iic . exposure levels of workers in industry from 500 parts per million (ppm)^to a 50 ppm ceiling, and at the same tine require workplace monitoring and, where exposure is greater than the 50 level, personal protective measures and equipment. The move-followed disclosure by officials of the B.F. Goodrich Chemical Co. plant in Louisville, Ky., of a possible connection between vinyl chloride exposure and the deaths of four employees ^of angiosarcoma--a rare form of liver cancer. Orie additional death subsequently has been reported from Louisville, and one each from Union Carbide's * 'South Charleston plant and Goodyear's Niagara plant. In addition, two present employees at the Louisville facility have been diagnosed to have angiosarcoma' of the liver. Under the law, the emergency temporary standard serves as a proposed permanent standard. 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