Document zQrb06Ebv0gyx387y37vexvNR

* *7S ' < i. # I PROPOSED tUUS 14215 fb> Technical eervicu. * U> The builder-developer propoatng a aw subdivision which an, bare M r am dwttiiag rites win wot the wrtw at rite planner, axeMteot, ted--M architect. or wntoitr. reg, istered or otherwise certified as qualified need sinoe that time. Only certain for- ndadmw of PVC. however, are Priarwnrtlnned far nee in food packaging and therefore are exmnpt from dudSeattai as food additives and may bo uead with out pre-marketing claaranoo Iffthe Pood and Drue Administration. os drug fluids after they hare bean in contact with devices composed in whole r hi part of polyvinyl chloride. <) The effect on Mood and tissues of vinyl chloride extracted from devices tinmpmcl! hs RfcMe or In part of polyvinyl chloride huertad or Implanted in the la the stale la which the subdivision te to be constructed, to provide complete gleaning, drawings, specifications, and saporvMaa on loud, stmt, utility and gndbi development. (t) 'Oomplete technical services win he nWstniil aad paid for by the bonder- developer with his own toads. ft) At completion of construction (or Early in 1973. the Pood and Drag Ad- rnmistratioc began receiving reports of possible migration problems of Ingredl- ants of PVC bottles then being test mar keted for distilled spirits. As a remit of further analytical tearing, the Commie- riooer published the Mar 17, 1973 pro posal wherein he concluded that the nee at PVC fur the of eiooholic body. AH pereene hs peamarion of such data are iiiimiIIj requertad to submit It to the Food and Dreg Admlnlsh at,km to writing (preferably In quhmplicate). if at all pwrihle on or before June 21,1974. This data should bs sent to the Hearing Clerk. Food aad Drug Administration. Room -M. MOO Flshere Lane. Rockville. MD when construction win be accomplished foods may cause such foods to be adulter 30063. BooMred data may be aeea in the hi phases, at the end of each phase), the parson who is qualified and registered or earUflod la the state in which the sub division is to be constructed aad is pro ated. No PVC bottles bare been need for such purposes alnee ttufe. After the pub lication of the proposal, the Commieeloner began lnvestigaring scientific re above ofleaAhnlng working hour*, Mon day through Friday. The Pcsmnilonar recently received a petition from the Health Research viding supervisory services during the ports regarding the pomihle migration of Omup, 3000 P Street NW,, Washington, ptytnd of work n*h notify the FHA PVC container ingredients to nonalco D.C. 20036, proposing to prohibit immedi County Office In writing that all work has holic foods as weU. Agmcy action an this ately the continued uae of vinyl chloride baaa completed in substantial conform- matter and on the earlier proposal is ex ae a constituent or propellant of cosmetic anoe with the approved plans end speci pected to be published shortly in the aerosol products aad of polyvinyl chlo fications Pbbbsal Rxoixtxx. The Commissioner is ride ae a container material for any cos * 3. Amead 11304.67 as follows: also considering the applicability of this metic product which can leach out de information to various drug products tectable amounts of vinyl chloride from packaged In PVC, and to various devices the polyvinyl chloride container mate 11304.67 Streets. composed !n whole or In part of PVC rial. The petitioner contends that there fa) Hw subdivisions and expansion of existing subdivisions. (1) Streets must conform to master atreet plans, design standards and eontraction specifications of the applicable public body, city, town, county or state and the requirements of the FHA. De velopments with more than 30 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 o,* 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 Pbod and Drug Administration and to fashion the appropriate regulatory ac is substantial evidence that vinyl chlo ride monomer is carcinogenic. A copy of the petition end letter of transmittal to the Commissioner are on file in the Office of the Hearing Clerk. The Commissioner baa reviewed all cosmetic product ingredient statements on file with the agency, representing ap proximately 60 percent of current market formulations, as of February 1.1974, and has ascertained that no information ex ists In these files Indicating uae 1 vinyl chloride In cosmetic aerosol products. (49 UM.C. 1480`a; Oelagatlos of author]tv by hae. Of Afr_. 38 FR 14944. 14343. 7 CFR SJS; OalaQtton of authority by the Aaat. Bac. for aural Development, M FB 14044, 14063, 7 OPB 3.70). tions that should be taken to assure full 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 Furthermore, the Coemetic, Toiletry end 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 spray nuns B. Elliott, Administrator, Farmer* Home Administration. IPO Doc.74-0183 Med 4-10-74:0:46 am] vironment and to initiate coordinated ac tion to mlntmlre 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 company contacted has manufactured products containing vinyl chloride since June 1973. In 1973, according to this informal tioo. two companies produced vinyl chlo sponse to the following points relating to ride-containing products with a total DEPARTMENT OF HEALTH. the use of polyvinyl chloride in contain volume of approximately 1,625,000 units. ers for food end oosmerics, and In de The CTFA estimates that the percentage EDUCATION, AND WELFARE vices: of hair spray cans manufactured in 1973 Food end Dreg Administration [ 21CFR Farts 310 end 700 ) (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 Rearing Clerk. DRUG AHDXOSfcimc 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 PiKMt Rectstct of May 17, this content. be a violation of the Federal Food. Drug, 1973 (33 PR 12931). the Commissioner of (3) The rate and level of vinyl chloride and Cosmetic Act. Wood 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 Unere by various foods and Drug Administration has recently tioned polyvinyl chloride (PVC) resin. and cosmetics. Including data derived reviewed Its files and conducted a sur Polyvinyl chloride is a polymeric resin after periods of storage. rey of all known drug manufacturer* 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 -nitride from cos to which vinyl chloride is used as a com of food po;!;sjIn; r.'.ctiri.ilc prior to the metics end devices when m contact with ponent, including propellant, in mxh pa :. r? of the F:':: Am::.1:;' esents 01 Ivdtf anu - nr rn'ir*ux riembmre. ' +1 ? ri liC fcliijj C VAer-ViJ L ij* ki i A* *' Th" c:'-b' L-"n~ ' , . . ; ; . i r-f \~'.vj ^ NDEftAl tEGISTft, VOL 3*. NO. 71--MONDAY, AKIl 32, 1*74 OU 1369 * 14216 PtOPOTO tuns propellant to aerosol preparations. While f," i1-' !:-.r-'rr)i..'-Ti in the !:; lu\ ,i 1;. - thj levicw ol Uie agency end preUmlDary imUi of 11m wtw> tndl- cstt that vinyl chloride la not currently being used In aerosol drug product*. There an no approved new drug appli cation* tor vinyl chloride as a component of any drag. There i> evidence, however, that manufacturers of aome over-the- counter drug product* uaed vinyl cblo- vide a* a nrooOUant until 1973. To determine the full extent that vinyl 1* uaed in drug product* and to determine if any additional action i* needed to protect the public, the* la published elsewhere in this Issue of the Fxsexal Rioxnx, a notice, pursuant to 112X7(a) (41 (31 CTO 133.7(a) (4)). ct the regulation unde the Drag 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 container* com posed of or lined with polyvinyl chloride. The Commissioner has determined that there are sufficient yifatlftr, 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 recognised as safe and af fective. is a new drug within the meaning of section 201 (p) of the Federal Food, I>r; and Cosmetic Act, and requires an Minuted new drug application as a con dition of marketing. There is ample evidence that vinyl chloride can result in acuta toxicity manifested by an array of symp toms, including unconsciousness as a re sult of high concentration of Inhalation, Cardiac effect*, bone changes, and de generative changes in the twain, liver, and kidney* have also been reported In animals. Reported studies also demon strate carcinogenic effects In animal* as a result of Inhalation exposure to vinyl chloride. Of most significance, however. Is the fact that vinyl chloride has been linked to liver disease. Including liver oaneer. in workers engaged in the poly merization of vinyl chloride to FVC. The scientific articles providing this evidence are on file in the Office of the Hearing Clerk. In view of this evidence, the Com missioner concludes that the banning of vinyl chloride as an ingredient in drug and cosmetic aerosol products is re quired. These products are often used m the of a smaD room where the level of vinyl chloride to which the Individual may be exposed, although usually only for a short time, oould be significantly hr excess of the mle Wei established In connection with occupa tional exposure. As a corollary to this eooduslcn. the Commissioner has requested all known manufacturers of such products with supplies still on the market to recall these supplies from the market to the re tell level, and requite will ha well of any additional such manufao- vtdoal may ba exposed could be signlfl- tilffit'* Jf p# '`^w evp * 'T ***4i*i pwvon- loml TJ i-il'wroi il.;f fficturcu co~.n-MT.,-d sueh Kiw a* of April 2. 1974 and a drag and mnmatle manufacturer, MaitWri aft* a Ale march, bagan recall of eeveu drag and three cosmetic aaroeef products as of ui cohnu-lion viiii occupational Winiiira S',-,i.<i Uuliiiaim* that vinyl chloride tehatatVwi aan remit tn acute torietty manfftoted by **' 1 1 headMho. rttoatentottop. and unoonadoua- April 9.1974, following an April 4. 1974 ganie effaete In animals as a raeult of Therefore, penetrant to proririona of the Federal Food, Drug, and Cosmetic Act (sees. M2. 90S. 001(a), 701(a); 92 tat 1050-1059, as auundad; 21 UAjC. 992. 999, 991(a), 971(a) > and under anthorlty driacatod to ths Gommiariooar tahalatkm mpoaora to vinyl chloride. Furthermore. vkryl chloride has raoentty bean Until to Knr disease, including ttvwr oaneer. In workers engaged in the polymerization af vinyl chloride. It is the stew of Urn <fW--that vinyl of Food and Dew* t*l CTO X130). It la proposed that Farts 319 and 790 ba amended as follows: l. Hr adding a now I919JM to Rubpart s of Fart 910 to mad as fOOowa: | S10A06 Dw of vteyl aUerida as an hmradjroOadedj^pseFdlmi, ad (a) Vinyl chloride has bam need as a propellant to aerosol drug preparation*. Evidence indicates that vinyl chloride Inhalation can result hr acute toxicity manifested by dhrinma, headache, dis orientation, and unconsciousness when Inhaled at high CanUae effects, bone changes, and degenerative changes ta the brain, liver, end kidneys have been reported In Studies also demonstrate carcinogenic effects In animal* as a result of Inhalation expo sure to vinyl chloride. Recently, vinyl chloride has bean linked to User disease. Including liver cancer. In workers en gaged m the polymerisation of vinyl chloride. (b) The Commissioner finds that there is a lack of general recognition by quali fied experts of the safety or effectiveness of aerosol drug preparation* containing vinyl chloride as an ingredient, includ ing propeffant. Therefore, any such prod uct containing vinyl chloride is a new chloride Is a driateriom mbatopca which net that contains It as an ingradtent Jnjariona to users. Accordingly, any cos metic aamaiil product containing vinyl chloride as an ingredimit is deemed to ba adulterated under section 901(a) of the Federal Food. Drug, and Cosmetic Act (b) Any cosmetic aerosol product con taining vinyl chloride as an ingredient hipped within the Jurisdiction of the act la subject to regulatory action. interested -- may. on or bafara May 33.1974. fils with the Hearing Clerk, Food and Drug Administration, room 4-M, 9900 Fishers Lone. Rockville, MD 30852, written comments (preferably hr quintuplicete) regarding this proposal. Comment* may be accompanied by a memorandum or brief In support thereof. Received comment* may be aeen hr the abovt office during working bouts, Monday through Friday. Dated: April 1. 1974. A. M. ScaKIM, Commissioner of Food and Drag*. tvn Dcc.74-Mte Filed 4-l-7;a:4> IB) DEPARTMENT OF TRANSPORTATION drug and a new drug application ap proved under section 90S of the Federal Food. Drug, and Ctomstlr Act is re quired for marketing. (c) A completed and rignad Ktottoo of C3aimed znveatieatianal funatlm for a New Drug" (Form FD-1571), as sat forth In (31X1 of this chapter, i* re COAST TWO [sscntpwrtitt] |OQD VU1S] NEW MVER SOUND AND STRANAHAN RIVER, FLA. quired to cover clinical investigmilcos designed to obtain evidence that such preparations are safe and effective for the purposes intended. (d) Any such drug within the Juris diction of the act which is not In accord with this regulation is subject to regula tory action. 3. By addhv a new 1700.14 to Subpart B of Fart 700 to read as follows: 1700.14 Use of vfayl ddertde aa so te> gradient, tedadiag propellant ef eaa- At the request of the Florida Yacht Chib Council, the Coast Ousrd is ocnridertng revoking the regulations for the Best Las Olas Boulevard drawbridge across the Atlantic Introooestal Water way in Fort Lauderdale. Florida, to re quire that the draw open on signal. Pres ent regulation* allow closed periods from November 15 through May 15 from 7 ml to g pm. during which the draw need ,, only open on the hour and half hour. This change Is befog **>**"--* tar the fol lowing nans: (a) Vinyl chloride has been umd as an (a) The regulatians presently tn forot ingredient in cosmetic aerosol products Wuinwg pair sprays. Where such aero sol products are umd m the amflnm of a email room, as is often the ease, the level of vinyl chloride to which the mdl- wan issued on March 15, 1950 (15 FR 1451), and were amended on July X 1953 (19 FR 9782), October 28. 1955 (20 ra 81W. MMiOctober 20,19M(21TR 9094). netsm. vol ze, no. n--monoat, ami sx iw OLI 1370