Document Nkv7vJR5yeBV6mEeg7onEvLy

1*5 11308 RIAES AND RIOULAIIONS This MMndmnt puelpuuee the af 1974). because that original retroactive fective date of the subject regulation ban waa set aside for failure to bold a hem March 33, 1978, to Mar 22.1878. > bearing on objections to the retroac and Must be made effecttee bxuoedl- tive affect of the regulation end be *iy to acranapUah Its purpose In the cause retroactive application ofthe public Interest It does not appear that Tagulatkmjb no longer neeemary..''* future sale of -adf-ntemuriaed hold products enwmmmy .vinyl chlo ride monomer was not objected to. .. In a decision published tn the Fionaat Ramans on Ootober.il. 1074 (89 FR 84676), the Comnrimion found that y ' public participation In this ruiemaMng ^DATER The effective date of the rule . none of .the objectiong reoelved war proceeding would make additional rel evant information available to.the De 4a June tX 1978. The ruleJe TrllwM Ao products .which are.mahufacturad partment - or Imported cn or after..October:7, ranted a stay.-of the effective date nf .the order<pr the holdingf a public -hearing. ThesOommlirion _ AooonUiigl7..snder the wdmlntatea- 1974. Any WTtttro~9bJectkK* MnVbe .none of the objections contained aief-* tive procedure provisions of 5 DAC. 888, It Is found upon gdod cause that' further notice and other pubUe proce-. "received hr April 34.1978^;; FOR -FURTHER. JNFORMATt erence to area offerto presentfactual: -^formation ivMdnnigtrhid tie durg with respect torthc amendment - (^`gaiESI to that reached byfb^stt are tmoractioeblc. imnooemary.-and iChariee ~sr (.jitibo,; Oot contrary to the public interest.-' u . . . Product safety Chmmimlon, Direo- Done at Washington, D.C,, this 33th , torste for Compliance and taltim- dap of March 1978.: r.- y*-. /_/ j': - mant, Division of-Regulatory Man* ^ . agrment, Washington. 80307, Non.--The atmi and Rant Health In- ::As a raeultof Um Oenniterimrt rul- -Inga an the objectiong. a petltlon for -review of the vinyl ban as It pertained to goods Introduced Into tn- tentete.commerce prior to the affec tive date of the ban was Hied In the maeUcn gervfce hm determined that this document does net contain a major proposal requlrlns prepareUen of an Inflation twini* ntalmiisni under order 11131 and OMB Circular A-10T.- . QUFFLEMENTARY INFORMATION: a- ''.~ 1,e.i-M",amtnSv' *.*' ri--V 't-r: On August 81, 1074 the Oommlmlon United States Court of Appeals for the Ninth .Circuit on-October :3.: 1974. (Factra Industrie* Jnc. v. Consumer Product Safety'OommJmian. Nos: 743003; 74-8108). That court. In an opin E. A. Bimiij1, ^ published far the Frosts;. Rkbib, 89 ion filed on May 8,-1977, set aside the Actinff Deputy AdminUtrator. FR 80113, a final regulation pursuant vinyl chloride baa on the basis that a Veterinary Service*. to section RqxiXB) of the Federal public bearing on the objectiong ZFR Doe. 7S-S010 Filed t-tt-T* J aaal Hazardous Substances Act (FHSA), 16 should have been heldJ* >--U.8.C. 1361 (qxiXBl, declaring any In an effort to determine the appro self-pivemrlsort'products intended,or priate regulatory responee to the [8355-011 - . ' > ,`>V TMo 18--Commercial Putllmi suitable for household use that con Factra decision, the Commiarion Waff tain vinyl chloride monomer as an tn- undertook a field survey to determine gradient or Intbe propellant to be the extent of vinyl chloride-containing j*haaned hamrdoua substances" (the In the 'merketplace. That aum 14--CONSUMER PRODUCT proposed "regulation was published In revealed that no.new such SAFETY COMMISSION the Ttanu w---- cn May 38.1874 p--mnrtM MBtUmwi ewyl i*WM* hiS (80 FR 18118)). The rv--took been manufactured atnoe 1074 and nnuANCBACT iiouiAiiaw that action beoanae of scientific stud- that, with the exception of three rela lea linking the death of Industrial tively mail lota bring beld. virtually .wurfcen tram a rare form of liver no products containing vinyl chloride PART 1500 HAZARDOUS oanoer to vinyl chloride exposure and In the marketplace. The STANC1S AND ARTICLES; ADMIN- because of certain animal studies fur ISTRATION AND JNFORCKMBfT REOULATIONS / ther the carcinogenicity of vinyl chloride monomer. In that mine document the Commission declined to Self-Pressurized NousohoM erodes anydbcratioD. which It might have had under the FH8A. to make ha stances Containing Vinyl Chloride |MI order prospective only, thus Monomer; ClaisIfltaHen es requiring .repurchase of products al ready distributed under the provisions pf section 18 of the FHSA (18 UH.C. AGENCY: Consumer Product Safstp 1374X That *""""* alao provided, as b required for the taeuanee of regula- ACTION: Rriasuanee af final regain-' ~Uon.' pursuant to maUon KqXlXB) of that the procedures for Hi nder section 701(e) of the gitacted the 3 Anna hoidtof the products and asked that they voluntarily destroy their existing tnventoriea. The firms subsequently reported that the inventories had either been destroyed or removed from Oommlwlnti Jurisdiction Became the-Information available to the Gemmiarien fauMoatee that , vinyl chloride-containing aeroeols are no manufactured or bald the Oommlarion eentMum to believe that such products. If pro-. Quoad, would present s risk of serious SUMMARY: The CovnmMrtnn retaues a regulation classifying any household substance In a eclf-muaeiutoufl eontaln- Federal Food, Drug and Comaetic Act would guvetu gad that adversely afliQ^ |MI fwbf WMhedmmted a'riayMtbripwnaB^ri the Vhiyl chloride ben whkta tequbed lepur- er containing vinyl chloride and raquaata for a public hearing as a 'banned hazart within 80 days of the publication of under the Federal Hamrdoua Sub the Court is (sited to stances Act The Commission believes Four statements containing at the He- that there is ample srientlfle evidence Nani and nqueata for a public Aet(KB>ax4a to establish the eardnogenidty of wen received by the Crwnmlaelon The vinyl chloride monomer by Inhalallon objections filed focused primarily on and io demonstrate that human expoaura to vinyl chloride the fact that the ban applied to prodalready hi the bands of tol review of the ban and eondudad that the would net have a result In a rare form of The Commission la reissuing this regu lation on a pruapectlva basis, as of the date of the original ban (October 7, suppUen and required that b lopnrrhaaart by the The Commission's as It prohibited the that so mrtranmmtol waa aot oammary. The the Way sod the baa rei In effect until Her X19TT. VOL 43. MO.: H. MA8CN H HR OLI 3284 KULIS AND KfGULATIONS 12309 Hines* or injury, the Commission akin) angiosarcomas in the' offspring hour period and a of B ppm av ' tedded to reissue its regula f rate exposed to vinyl chloride eraged over any period not exceeding tion on a prospective basis only, as of during pregnancy. (IARC Monographs 15 minutes (89 FR 38890). On August the date of the origingal ban (October on the Evaluation of Carcinogenic 28, 1974 the Food and Drug Adminis T, 1974). Such action will Insure that Risk of Chemicals to Man. 7:291 tration (FDA) published Anal rules ap no self-pressurized household sub (1974).) plicable to the use of vinyl chloride stances containing vinyl chloride mon In addition, vinyl chloride monomer monomer as an ingredient of aelf-pree- omer are manufactured in the future. animal studies are currently being per surtaed drug and cosmetic products. 1^ - Qaotnms roa rax Ban formed at Edgewood Arsenal for CP8C The use of vinyl chloride in aelf-pree(1978-1978) under an interagency surized cosmetic products was banned, Vinyl chloride is a colorless, flamma agreement. The results of those stud and an approved new drug application ble gas under normal conditions of ies are expected in the second quarter as a condition to marketing was re-, temperature and pressure, but is gen of 1978. qulred for all aelf-preauriaed drug erally handled as a liquid under pres sure. Among the synonyms and trade antnunnsra ' products mttetwiwy the substance (39 FR 30820). On April 28.1974. the Envi names for vinyl chloride are chlor- oethylene, monochloroethene, ethyl ene monochloride, vinyl chloride mon omer, VC and VCM. - Vinyl chloride monomer Is not known to occur in nature. The sub in early 1874, the &P. Goodrich Chemical Company reported to the National Institute for Occupational Safety and Health (NIOSH) that since 1971, three of its employees, who had an average exposure of approximately ronmental Protection Agency pub lished an emergency suspension order and a notice to cancel the registration of all pesticide spray products contain ing vinyl chloride that are used tn the in food handling establish- stance has been produced oommerdal'' 19 yean to vinyl choride monomer at in hospitals, or In enclosed ly in the United States since at least unknown concentrations, had died (29 FR 14782). This notice stated IMS. In 1971, at least 97 percent of from angiosarcoma of tt liver. that under some conditions of use of the vinyl chloride monomer consumed At about the same time reports of 10 aerosol products tn h uaebolds, the in the UJS. was for the production of other deaths wn em concentration of propellant tn the air vinyl chloride homopolymer and copo ployed at various vinyl chloride could be aa high as 400 parts per mfl- lymer resins. The remainder was used monomerpolymeriaations . plana ap Hon immediately after spraying. The in a variety of ways, such ss the pro peared tn the literature. In two of the registration of a number of pesticides duction of methyl chloroform, as an reported cases, angiosarcomas were was subsequently cancelled under this additive to'Specialty coatings, and as a ' present in tissues other thaw the liver. order (see 40 FR 1494). component of propellant mixtures for (Heath. C.W., Jr,, Falk, H. and J-L. certain aerosol products. Creech, JT. "Characteristics of cases of Braaiu Dan * 4nutnin - Vinyl chloride has been shown to tie angiosarcoma of the liver among vinyl The regulation set forth carcinogenic by inhalation in animal chlorite workers in the United below applies to all aelf-preesurtsed Moaasays. In addition, a casual rela State*". Ann N.T. Acad. ScL (1974)). household products --iteiwiny vinyl tionship has been demonstrated be At the time of Its 1974 ban. previous chloride monomer aa an Ingredient or tween exposure through inhalation of ly dtod herein, the Commission was In the propellant manufactured or im worken to vinyl chloride monomer aware of 24 confirmed cases of angio ported on or after October 7,1974. the during the polymerization process and sarcoma among the 10.000 to 20,000 effective date of the Commission's the onset of angiosarcoma of the liver, persona expoeed to vinyl chloride in. original *""" order. The regulation a very rare form of live cancer. The the course of their employment. As of will, therefore, permit existing stock and human data demonstrat August 1077, NIOSH reported a total manufactured or imported before that ing the carcinogenicity of vinyl chlo of 83 cases. of Bver angiosarcoma date to be sold. Since the information ride was reference in the Commission's among worken directly involved in the available to the Commission Indicates 1974 proposed and final vinyl chlorite polymerisation of VCM. Twenty-five that such products are no longer being banning regulations (39 FR 18115; 19 of the euee developed among worken manufactured or held, the Commis FR 30112) and Is summarised end up in the UA, with the other 28 cases ob- sion believes that the primary effect . dated below. ' tn worken from It other ooun- of'this regulation will be to insure that ' ~ ` ~ "1. AimtAL DATA * ' " (Table i. Reported Cases of An- - vinyl chlorite monomer will not be gjoearcom* of the Liver Awwwtf vinyl used as an ingredient or a* a propel- In 1974 Professor Cesare Maltonlof Chlorite Polymerisation Workers, sub-' lent la household, products In the the Institute dl Oncologic. Bologna, mlttod by NIOSH (August, 1977)). As future. * Italy, reported on a series of experi angiosarcoma of the liver is extremely The regulation is affective June 22. ments on the effect. of exposure rare in the general population, there is 1971, except as to any provision that through inhalation on rats, mice, and agreement among adentlsta that this may be stayed by the filing of proper hamsters to vteyt (WfliM* iwwurft iil~osi ntUsi of 88 eases in-vinyl chlo objections. Any written objections . concentrations of 10,000, MOO MOO. rite monomer worken is evidence of a must be tiled by April 24, 1978. The 900. 380, and 60 ppm for varying peri- - inti . m consider sD objec oda of time Preliminary remits of this tions prior to the effective date of this study included the obeervation of an- ban; and aa aa alternative to staying gjosaroomaa of the liver in both rate In addition and mioe expoeed to vinyl chloride at human i the ben aa a result of the objections and'holding a bearing. tbifOommJa- concentrations as low as 250 parts per- dnogenidty. of fifliidifi tw ^ullfnirt1 , the were induoed at several other rites in taken by other both .mociea^ (Maltoni. -C and a. In this ban. For to'section^ldllA of the famine. "Cardnogenietty Mrn--ji on tober 4.1974. tbs'Occupational Safety md interim vinyl .chlorite. L Reoearchplaa and' and-Health - - - the lfidaoil ^eerly reeulta." tttvlronm. Rea* 7387 a final standard fan oMtgei^ tempo Mronmentil Policy Act (NEPA) (16 -0074)). ' u*-Ss rary standard and arpropoeid standard CPR 1021), the Executive Director of A preliminary^studies have bad been published earlier) --***ng an the- Gommimion has determined Olid vinyl i*iw<*i monom oorupaMonal exposure Unlit for vinyl this ban is not e major action, that its subcutaneous (oecurring beneath the chlorite of rppm averaged over any 9 the environment win be voc 4k no. , MW*, OLI 3285 - a* 13310 HIUS AND tfOMATIOMS negligible, tad Hut no environmental Mfoontt' llw Am todicittd Any person who will ho adversely ef ipvlew It ntc ftry. The Executive Dl- * above. 3t has been reported that vinyl fected by the foregoing-order may at roctorl . determination,' a oopy of chloride monomer may be present .in any time on or before April 24. 1172. vhlcb la ouflle at the Offloo of the tbs air in --witwH-- y great as file with the Offloo of the Secretary. Secretory, ocochMlsd Hist the ben 400 parts per tmian after household Product Safety Commto- would bevt no environmental wffeot uae of self-praaeurtoed contain-- wttb llll ifth Street JTW.. Washing- --TM no product which would be af- . vinyl chloride Jn the .-propellant. DA 20207, written objections fected by the ben le currently being - Tumors have been toduoed In mtoe thereto,-preferably In fiveaopiee. Oto- produced or held In Inventory. There Aftm'jtxpMurCto VCM In. concentra jectlone shall ahow whantetha parson fore, statee no vinyl chloride earaoto tions as Jew as 200 parte per mDUonSrv . mai vD ho advMBy affected by the are currently. In the diannato at oom- x'Beeauee no mfe level of human ex the environmental taeue of dto- posure,to vinyl chloride monomer has of repurchased product* which M4B wtabltehM* ^ ootnoWori fur* , v. v ~'.vMt at Lime of the initial ban le now moet.-(At that ttma the CmnUn had conchidad -that dtopoaal of oanoentntlcoa of vinyl chlo ride aeroaola could be acoompltabed without significant envtnmmantal dancer. (40 FR 41170).) -v_ CcoKLunom . Char has daddad to. affirm tta earlier i Umilug tbftt idoQuiti Quttiomy cannot' be written under the for mlf-pressurised household vinyl chloride The concludes that the and nature of the by the uae of eslf- taininp yai to auch that the public ______ tbatwrs not frivolous or tnmnswiusntlsl a t hearing to re quested, the objections must state the imuos for the hearing, Objections may ;be aeeompanied by a memorandum or brief in support thereof. fUostved ob- Jactlcns may be asen la.tba above office during working home Monday Section XfXlXA) Federal Subatenoee Act define! health and safety ean be adequately served only by keeping such products through Friday.* -. -/ effective data: The regulation pro substance" aa "any aubctanoe or mix out of the channels of Interstate corn- mulgated above shall became effective ture of aubatanoea which la toxic x: If meroe. -Therefore, on the effective June 22,1278, except as to any provi auch eubatanoe or mixture of sub- date of the regulation promulgated rion that may be stayed by tbs filing taporo may cauaa aubatantlal pereanal below, all self-pramurtoed household of propur otafwtlcue Am. tadftdtttd Injury or aubatantlal fllnesa durtnc or products containing VCM manufaoi above, as an sltsraattve to staying tba aa a proximate reeult of any custom tured or Imported on or after October ban as a mult of any objections and ary or reaeonahly foreseeable handllnt 7,1974 became banned bamrrious aul* bolding a hearing, the Oommtorion or uae, tocludlns reaeonahly toriaee may revise tta -final order. Mottos of sK)s hiwHftn toy chlldrflll**' flactkO Accordingly, pursuant to provtotahs tba filing of objections or the lack Kg) of the act states that the term of the Federal Haaardous Subatanww thereof or any mending of the final "toxic" Includes any substance or mix Act (ssca. KfXl), (AX (B). is). order win be given by publication In ture of substances which has the ca <4X1XB>, 2(a>. 74 Stat 272. 274. as pacity to produce personal Injury nr nineas to man throuyh ingestion, Inha lation. or absorption through any body surface. Provisions of section KqXlXB) authorise the Commtorion to Issue regulationsto classify a "haw ardous substance" which Is packaged or suitable for use In household! as a "banned hazardous substance" if the Oonmimlan determinea that notwlthtiiifai| mi cautionary labeling which may be required under the FH8A. the degree, or nature of the hamrd Involved in the presence or use of the substance in households Is such that the public health and safety amended 20 Stat. 120-04. 2 Stat 187- 122. 00 Stat 202; 14 DAC 1261.1242) and the Federal Food. Drug and Cos metic Act (see. 701 (e). it), (g), 52 Stat 1065-66, H amended 70 Stat 910, 72 Stat 042; 21 UAC. 271 (eX (fX (s. mu< -under authority vested In the ftTM** WwidmW nnwiml--fam by the (Tnnntinar Product Safety Act (see. 20(a). 80 Stat 1221; 16 UA.C. 2070(a)). 10 CFR 1600.17 to aiaended by daletlnx the saraxrahh (aXlO) and by adding a new peregrapb (aXlO), as follows (unchanged, the In troductory text of paragraph (a) to In cluded belowfar context): . atfXH (AX ax (gX (qXlXBX KaX 74 IhlKw emutod SO gtaL 1SS4-SS, 81 Stax lSI-im. SS gtaL MS (It UACL USX 12m see. fSi (ex tfx (S>. 62 SUL. 1SSA-M, m MMSI TO SUL. Sis. 72 SUL sa Ctl VAA 271 (SX (fX (I)* Si . 1211 (16 DAC 2eiMa)X) Dated: March 17.1976. Stun E. Dow*. ActingSscista/ Conntmer AofiiBlAMiCtoimiiiloiL (re Doc. TS-TS1S FOsd t-aa-TS; 41 am) [1506-01] be adequately served only by ` - that substance out of the channels of Interstate commerce. After careful consideration of all IMU7 --il iiutlm mnim. (a) X7nder .the authority of KqXlXB) of the act the IMall ourm t-raoo and okuo ad- available Information as dimmed above, o** Commission baa decided to affirm its earlier determination <aee 89 FR P0112) that atlf-preerartad house hold products vlnyl -chio- ride monomer are toxic haaardous sub stances within Um mooning of sections the following articles they such a degree wnature of > ***** ftdtQHAte wiUcikiry moot be written and the . public health and safety sen be served only by keeping sueh'artHeeout-of tn- MMtSTtATlON, OMAITMBff 05 .MALTH, MUCATMN, AND WfU -"5AM 2 <f) and <g) of tbs FH8A because vinyl chloride monomer, when in haled. baa the capacity to produce Qineea, specifically conoar. (10) Self-premurimd produets In- The Commission believes that ample tooded -or sultahle far household use evidence In the form of scientific studlee and Chemical reports Is available to aetshUsh the carcinogenicity of vinyl mffiwmf Up liiliiliMiw mm! that contain vtnyl chloride monomer as an Ingredient or In the propellant manufactured or Imparted an or after October 7.1274. Ctorveotion to FR Doc. 76-9061 appearing on to demonstrate that human exposure m the of Friday, to the substance can result in March 10. 1970, on In the' tv, auacM si ms OLI 3286