Document nkBDpOy26ykMmJ4X5r0Jenqqw

COPED 13224 - 13225 PROPOSED RULES ' 14215 (b) Technical services. " * ' - used since that time. Only certain for ous drug fluids after they have been m (1) The builder-developer proposing mulations of PVC, however, are prior- contact with devices composed in whole new subdivision which will have 10 sanctioned tor use in food packaging and or in part ot polyvinyl chloride. or more dwelling sites will secure the therefore are exempt from classification (8) The effect on blood and tissues services of e site planner, architect, as food additives and may be used with 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 certified 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 mult 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 for by the builder- sioner published the May 17, 1973 pro data should be dent 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 m 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 ports regarding the possible migration of Group, 2000 P Street NW,, Washington, period of work shall 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 well. Agency action on this ately the continued use of vinyl chloride been completed In substantial conform matter and on the earlier proposal Is ex as a constituent or propellant of cosmetic ance with the approved plans and sped- pected to be published shortly In the aerosol products and of polyvinyl chlo Federal Recistek. The Commissioner is ride as a container material for any cos * * 2. Amend f 1804.67 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 | 1804.67 Sweets. composed in whole or in part of PVC rial. The petitioner contends that then (a) New subdivisions and expansion of rillting 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 substantial evidence that vinyl chlo ride monomer is carcinogenic, A codv of the petition and Vter of transmittal to the Commissionaire on file in the Office of the HearingSerk. The Commissioner has revised an cosmetic product ingredient st&Bments 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. <43 t7S.C. 1480's: delegation of authority by Bee. or AgrL, 38 TR 14844. 14848. 7 CFR 3.33; delegation of authority by the Asst. See. for Rural Development, 88 F8 14844, 14863, 7 CPH 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 Cosmetic, Toiletry and 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 15,1074. fect of vinyl chloride on the total en cluding the major aerosol hair spray FaAiuc B. Elliott, Administrator, Farmer* Home Administration. [FD Doc.74-8183 Filed 4-18-74;8;46 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 company contacted has manufactured products containing vinyl chloride since June 1973. In 1973, according to this Informal tlon, 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 -and cosmetics, and In de- - The CTFA estimates that the percentage EDUCATION, AND WELFARE vices: of hair spray cans manufactured in 1973 Food and Drug Administration . (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 121 CFR Parts 310 andOTT" liner and type of product. mation received from the CTFA is on VINYL CHLORIDE AS AN INGKMENT OF (2) The vinyl chloride content in poly file in the Office of the Hearing Clerk. DRUG AND COSMETIC AEM0L PROD vinyl chloride used to manufacture or There is no known past or present UCTS TW 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 Feberai Recistek of May 17. this content. be a violation of the Federal Food, Drug, 1973 <38 FK 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 and conducted a sur-. Polyvinyl chloride Is a polymeric min after periods of storage. vey of all known drug manufacturers of produced by polymerization of vinyl (4) The rate and level of percutaneous aerosol products to determine the extent chloride which was used ss 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 (8) The vinyl chloride content of vari chloride In drug products has been as a KDIRAL ItOISTIR, V L **, NO. 78--MONDAY, AMI 23, 1974 ASI 000013224 K *14216 PROPOSED RULES r 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 hot currently manufacturer, identified after a file toxicity manifested by dizziness, head . being used in aerosol drug products. search, began recall of seven drug and ache, disorientation, and unconscious There are no approved new drug appli three cosmetic aerosol products as of ness where inhaled at high concentra cations for vinyl chloride as a component April 8, 1974. following an April 4, 1974 tions. Studies also demonstrate carcino of any drag. There is evidence, however, request. genic effects in animals .as a result of that manufacturers of some over-the- Therefore, pursuant to provisions of Inhalation exposure to vinyl chloride. counter drag products used vinyl chlo the Federal Food, Drag, and Cosmetic Furthermore, vinyl chloride has recently ride as a propellant until 1573. Act (secs. S02, 805, 801(a), 701(a): 82 been linked to liver disease, including TO determine the full extent that vinyl fitat 1050-1055, as amended; 21 U.S.C. liver cancer, in workers engaged in the chloride is used in drug products and to 352, 355, 381(a), 371(a)) and under au polymerization of vinyl chloride. It Is the determine If any additional action is thority delegated to the Commissioner view of the Commissioner that vinyl needed to protect the public, there is of Food and Drugs (21 CFR 2.120). it is chloride is a deleterious substance which - published elsewhere In this issue of the proposed that Parts 310 and 700 be may render any cosmetic aerosol prod Federal Rtcam. a notice, pursuant to amended as follows: uct that contains it as an ingredient 1132.7(a)(4) (21 CFR 132.7(a)(4)), of 1. By adding a new 1310.505 to Sub- injurious to users. Accordingly, any cos the regulations under the Drug Listing -part of Part 310 to read as follows: metic aerosol product containing vinyl ' Act of 1972, requiring ah registrants to submit a list of all drag products mar keted containing the ingredient vinyl chloride or packaged in containers com posed of or lined with polyvinyl chloride. The 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 drag 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, Drag and Cosmetic Act, and requires an approved new drag application as a con- | 310.506 Dee of vinyl chloride os on' ingredient, including propellant, of eroael drug product* (a) Vinyl chloride has been used as a chloride as an Ingredient is deemed to be adulterated under section 801(a) of the Federal Food, Drug, and Cosmetic Act. (b) Any cosmetic aerosol product con taining vinyl chloride as an ingredient propellant In aerosol drug preparations. shipped within the Jurisdiction of the act Evidence Indicates that vinyl chloride Is subject to regulatory action. inhalation can result In acute toxicity manifested by dizziness, headache, dis orientation, and unconsciousness where Interested persons may, an or before May 22,1974. file with the,Hearing Clerk Inhaled at high concentrations. Cardiac Food and Drug Administration, effects, bone changes, and degenerative 8-86, 5600 Fishers Lane, Rockville, changes in the brain, liver, and kidneys have been reported in animals. Studies 30852, written comments (preferably 1 quintupllcate) regarding this prop also demonstrate carcinogenic effeets'ln Comments may be accompanied by animals as a result of inhalation expo-' memorandum or brief in sure to vinyl chloride. Recently, vinyl chloride has been linked to liver disease. Including liver cancer, in workers en thereof. Received comments may be seen in the above office during working hours, Monday through Friday. ditlon at marketing. gaged in the polymerization of vinyl Dated: April 16.1974. There is amrle evidence that vinyl chloride. chloride inhalation can result In acute, (b) The Commissioner finds that there toxicity manifested by an array of symp is a lack of general recognition by quali A. M. Sckkxdt, Commissioner of Food and I>mgs. toms, Including unconsciousness as a re fied experts of the safety or effectiveness (98 Doe.74-0232 Piled 4-l#-74::45 am] sult of high concentration of inhalation. of aerosol drag 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 SOS of the Federal a result of inhalation exposure to vinyl Food. Drag, and Cosmetic Act is re chloride. Of most significance, however, quired for marketing. * 133 CFR Part 117] fOQD 74115] 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 FVC. 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 1312.1 of this elppter, la 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 " designed to obtain evidence that such At the request of the Florida Vacht Clerk. In view of this evidence." preparations are safe and effective for Club, Council, the Coast Guard is con missloner concludes that the b the purposes intended. sidering revoking the regulations for the - vinyl chloride as an Ingredient (d> Any such drag within the Juris East Las Olas Boulevard drawbridge and cosmetic aerosol products diction of the act which is not in accord across the Atlantic Intracoastal Water qulred. These products are often used ,wlth this regulation is subject to regula way in Fort Lauderdale, Florida, to re in the confines of a smvll room where tory action. quire that the draw open on signal. Pres the level of vinyl chloride to which the Individual may be exposed, although usually only for a short time, could be 3. By adding a new 1700.14 to Bubpart S of Fart 700 to read as follows: ent regulations allow closed periods from November 15 through May 15 from 7 am. to 6 pm. during which the draw need significantly in excess of the safe level 1700.14 Use of vinyl chloride as an In only open on the hour and half hour. This established in connection with oecupa- gredient, tndodinc 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, 1950 (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 28, 1955 (20 FR these supplies from the market to the re tail level, and requests will be a small room, as is often the case, the level of vinyl chloride to which the Indi 8118), and October 30.1956 (21 FR 8084). These regulations were issued to ease vo- VCDftAl BfOISTtl, VOL 3t, NO. 7--MWBAY, AMUl 31, 1*74 ASI 000013225 T