Document 2q44p3zODm89xe1d55mL7v5X5

tT- 2_, O. PROPOSED 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 mulations of FVC, however, are prior- contact with devices composed in whole a new subdivision' which will have 10 sanctioned for use in food packaging and or in part of polyvinyl chloride. or more dwelling sites will secure the therefore are exempt from classification (6) The effect on blood and tissues services of a 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 result of (preferably Ip, 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 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 ports regarding the possible migration of Group, 2000 F 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 speci pected to be published shortly in the aerosol products and of polyvinyl chlo fications. Federal Register. The Commissioner is ride as a container material for any cos " * m 0 2. Amend { 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 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 tstreet plans, design standards and con struction 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 is substantial evidence that vinyl chlo fluids, or which may be inserted or im ride monomer Is carcinogenic. planted in the human body. A copy of the petition and letter of Because of the broad Interest in the_ transmittal to the Commissioner are on subject of vinyl chloride by both the pub file in the Office of the Hearing Clerk. lic and the scientific community because The Commissioner has reviewed all of its potential as a serious threat to the cosmetic product ingredient statements public health, the Commissioner has un on file with the agency, representing ap dertaken an agency-wide effort to explore proximately 50 percent of current market the problem in connection with those formulations, as of February 1,1974, and products within the jurisdiction of the has ascertained that no information ex Food and Drug Administration and to ists in these files indicating use of vinyl fashion the appropriate regulatory ac chloride in cosmetic aerosol products. (42 tJB.O. 1480'b; delegation of authority by Sec. of AgrL, 88 FR 14944, 14948. 7 CFR 3.23; delegation of authority by the Asst. Bee. tor Rural Development, 88 FR 14944, 14962, 7 CFR 3.70). Dated: April 15,1974. 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 fect of vinyl chloride on the total en 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 cluding the major aerosol hair spray Frank B. Elliott, Administrator, farmers Home Administration. . IPD Doa74-0163 Filed 4-19-74; 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 tion, two companies produced vinyl 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 [ 21 CFR Parts 310 and 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 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 In the Federal Register of May 17, 1973 (38 FR 12931), the Commissioner of Food and Drugs published a notice of jjroposed rulemaking for prior-sanc^Bned polyvinyl chloride (PVC) resin, ^^^yvinyl chloride is a polymeric resin produced by polymerization of vinyl chloride which was used as a component of food packaging materials prior to the passage of the Food Additive Amend ments of 1958 and which has been widely ers, Including description of the methods and extraction systems used to determine this content. (3) The rate and level of vinyl chloride extraction from the aforementioned con tainers or their liners by various foods and cosmetics, including data derived after periods of storage. (4) The rate and level of percutaneous absorption of vinyl chloride from cos metics and devices when in contact with the skin or mucous membrane. (5) The vinyl chloride content of varf- in food aerosol products. Any such use without a food additive regulation would be a violation of the Federal Food, Drug, and Cosmetic Act. With regard to drug products, the Food and Drug Administration has recently reviewed its files and conducted a sur vey of all known drug manufacturers of aerosol products to determine the extent to which vinyl chloride is used as a com ponent, including propellant, in such products. The only known use of vinyl chloride in drug products has been as a FEDERAt REGISTER, VOL 39, NO. 78--MONDAY, APRIl 12, 1974 CUSAROSS 02727 14216 PROPOSED RULES propellant In aerosol preparations. While all the Information requested in the survey was not supplied by manufac turers, the review of the agency files and preliminary results of the survey Indi cate that vinyl chloride is not currently 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, that manufacturers of some over-thecounter drug products used vinyl chlo ride as a propellant until 1973. To determine the full extent that vinyl 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. 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 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 dition of marketing. There is ample evidence that vinyl chloride inhalation can result In acute toxicity manifested by an array of symp toms. including unconsciousness as a re sult of high concentration of inhalation. Cardiac effects, bone changes, and de generative changes in the brain, liver, and kidneys have also been reported in animals. Reported studies also demon strate carcinogenic effects in animals 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 cancer, in workers- engaged in the poly merization of vinyl chloride to PVC, 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 in the confines of a small room where the level of vinyl chloride to which the individual may be exposed, although usually only for a short'time, could be significantly in excess of the safe level established in connection with occupa tional exposure. As a corollary to this conclusion, 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 tail level, and similar requests will he made of any additional such manufac turers if and as they are located. Two cosmetic aerosol hair spray manu facturers commenced such recalls as of April 2, 1974 and a drug and cosmetic manufacturer. Identified after a file search, began recall of seven drug and three cosmetic aerosol products as of April 8, 1974, following an April 4. 1974 request. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 502. 505, 501(a), 701(a): 52 Stat. 1050-1055, as amended; 21 UJ3.C. 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 310.506 to Bubpart 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 gaged in the polymerization 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 preparations containing vinyl chloride as an Ingredient, includ ing propellant. Therefore, any such prod uct containing vinyl chloride is a new drug and a new drug application ap proved under section 505 of the Federal Food, Drug, and Cosmetic Act Is re quired for marketing. (c) A completed and signed "Notice of Claimed Investigational Exemption for a New Drug" (Form FD-1571), as set forth In { 312.1 of this chapter, is re quired to cover clinical investigations 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. 2. By adding a new S 700.14 to Subpart B of Fart 700 to read as follows: 700.14 Use of vinyl chloride aa an in gredient, including propellant of cos metic aerosol products. (a) Vinyl chloride has been used as an ingredient in cosmetic aerosol products including hair sprays. Where such aero sol products are used in the confines of a small room, as is often the case, the level of vinyl chloride to which the indi vidual may be exposed could be signifi cantly in excess of the safe level estab lished in connection with occupational exposure. Evidence Indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, head ache. disorientation, and unconscious ness where inhaled at high concentra tions. Studies also demonstrate carcino genic effects in animals as a result of inhalation exposure to vinyl chloride. Furthermore, vinyl chloride has recently been linked to liver disease, including liver cancer, in workers engaged in the 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 by a memorandum or brief in support thereof. Received comments may be seen in the above office during working hours, Monday through Friday. Dated: April 16.1974. A. M. Schmidt, Commissioner of Food and Drugs. fra Doc.74-8332 FUed 4-10-74;8;45 am| DEPARTMENT OF TRANSPORTATION COAST GUARD 33 CFR Part 117] fCOD 741X51 NEW RIVER SOUND AND STRANAHAN RIVER, FLA. Proposed Drawbridge Operation Regulations At the request of the Florida Yacht Club Council, the Coast Guard Is con sidering revoking the regulations for the East Las Olas Boulevard drawbridge across the Atlantic Intracoastal Water way in Fort Lauderdale, Florida, to re quire that the draw open on signal. Pres ent regulations allow closed periods from November 15 through May 15 from 7 am, to 6 pm. during which the draw need only open on the hour and half hour. This change is being considered for the fol lowing reasons: (a) The regulations presently In force were issued on March 15. 1950 (15 FR 1461), and were amended on July 2,1953 (18 FR 3782). October 28, 1955 (20 FR 8118), and October 20,1956 (21 FR8084). These regulations were Issued to ease ve- - FEDERAL REGISTER, VOL 39, NO. 78--MONDAY, APRll 22, 1974 CUSAROSS 02728