Document zzwXqwMkd8EKMyR87kb29MemR

- PROPOSED RULES 14215 (b) Technical services. Cl) The builder-developer proposing a new subdivision which will have 10 or more dwelling sites will secure the services of a site planner, architect, landscape architect, or engineer, reg istered or otherwise certified as qualified in the state in which the subdivision Is to be constructed, to provide complete planning, drawings, specifications, and supervision on land, street, utility and grading development. . (2) Complete technical services will be obtained and paid for by the builder- developer with his own funds. <3) At completion of construction (or when construction will be accomplished in phases, at the end of each phase), the person who Is qualified and registered or certified in the state in which the sub division is to be constructed and is pro 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: 1804.67 Streets. (a) New subdivisions and expansion of existing subdivisions. (1) Streets must conform to master street plans, design standards and con- truction 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. *%" * (42 U.S.C. 1480's; delegation of authority by Sec. Of Agrl., 38 Fit 14944, 14948. 7 CFR 2.23; delegation of authority by the Asst. 6ec. for Rural Development. 38 FR 14944, 14952, 7 CFR 2.70). Dated: April 15, 1974. Frank B. Elliott, Administrator, ' Farmers Home Administration. [FD Doc.74-9152 Filed 4-19-74;8:45 am] DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE Food and Drug Administration [ 21 CFR Parts 310 and 700 ) VINYL CHLORIDE AS AN INGREDIENT OF DRUG AND COSMETIC AEROSOL PRODUCTS Notice of Proposed Rule Making In the Federal Register of May 17, 1973 (3S FR 12931), the Cemnirisioner of Food and Drugs published a notice of proposed rulemaking for prior-sanc tioned polyvinyl chloride (PVC) resin. Polyvinyl 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 tire Food Additive Amend ments of 1950 and which lixs been widely used since that time. Only certain for mulations of FVC, however, are prior- sanctioned for use in food packaging and therefore are exempt from classification as food additives and may be used with out pre-marketing cleafance by the Food and Drug Administration. Early in 1973, the Food and Drug Ad ministration began receiving reports of possible migration problems of ingredi ents of PVC bottles then being test mar keted for distilled spirits. As a result of further analytical testing, the Commis sioner published the May 17, 1973 pro posal wherein he concluded that the use of PVC for the packaging of alcoholic foods may cause such foods to be adulter ated. No PVC bottles have been used for such purposes since then. After the pub lication of the proposal, the Commis sioner began investigating scientific re 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 composed in whole or in part of PVC 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 ns a serious threat to the public health, the Commissioner has un dertaken an agency-wlue 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 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 vironment and to initiate coordinated ac tion to minimize tlris impact. In connection with this search for in formation, the Commissioner is particu larly interested in receiving data in re sponse to the following points relating to the use of polyvinyl chloride in contain ers for food and cosmetics, and in de vices : (1) The extent of usage of polyvinyl chloride by type of container or container liner and type of product. (2) The vinyl chloride content in poly vinyl chloride used to manufacture or line various food and cosmetic contain 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 bv 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 end devices when in contact with the skin or mucous membrane. (5) Tile vinyl chloride content of vari ous drug fluids after they have been in 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 composed in whole or in part of polyvinyl chloride inserted or implanted in the body. All persons In possession of such data are urgently requested to submit it to the Food and Drug Administration in writing (preferably in quintuplicate), if at all possible on or before June 21, 1974. This data should be sent to the Hearing Clerk, Food and Drug Administration. Room 6--86, 5600 Fishers Lane, Rockville, MD 20852. Received data may be seen in the above office during working hours, Mon day through Friday. The Commissioner recently received a petition from the Health Research Group, 2000 P Street MV., 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 rial. The petitioner contends that there is substantial 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 witli 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. 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 manufacturers, show that no company contacted has manufactured products containing vinyl chloride since June 1973. In 1973. according to this iiiforma-' tion, two companies produced vinyl chlo ride-containing products with a total volume of approximately 1,625.000 units. Tiie CTFA estimates that the percetuase of hair spray cans manufactured in iS73 which contained vinyl chloride is less than 0.4 percent. A copy of the infor mation received from the CTFA is on file in the Office of the Hearing Cicrk. There is no known past or present usage of vinyl chloride as a propellant 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 suivcy of all known drug manufacturers of aerosol products to determine tlie 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 lias been as a FEDERAL REGISTER, VOt. 39, NO. 79--MONDAY, APRIL 22, 1974 23210001 T 14216 PROPOSED RULES propellant In aerosol preparations. While all the Information requested in the survey teas 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 J 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 Ls used as an ingredient in cosmetic aerosol prod ucts and that such me 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 (he 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 elects, bone changes, and de generative changes in the brain, liver, and kidneys have also been re;x>iTed in animals. Reported studies also demon strate carcinogenic effects in animals as a result of inhalation exposure to vinyl chloride. Of most significance, however, 1s 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 PYC. The scientific article? 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 whore the level of vinyl chloride to width the individual may be exposed, although usually only for a short time, could be significantly in excess of the sale level established in connection with occupa tional exposure. As a coroltary' to this conclusion, the Commit-doner has requested rdl known manufacturers of such, products with supplies still on the market to recall these supplier, from the market to Use re tail level, and similar requests will bo 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, 601(a), 701(a); 52 Stat. 1050-1055, as amended; 21 UJS.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 Sub part E 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 Cosine tic Act is re quired for marketing. (c) A completed and signed "Notice of Claimed Investigational Exemption for a New Drug" (Form FD-1371), as set forth in 5 312.1 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 709.14 to Subpart B of Part 700 to read as follows: 700.1 t Use of vinyl chloride os no in gredient, including propeihint of cos metic Jirro-o! pi outiotw (a) Vinyl chloride has been used ns 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-S6, 5600 Fishers Lane, Rockville, MD 20S52, 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. 197-1. A. M.,Schmidt, Commissioner of Food and Drugs. [FR Doc.74^9232 Filed 4-I9-74;0:45 am] ' DEPARTMENT OF TRANSPORTATION COAST GUARD [23 CFR Part 117] |CGD 7-1115] 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 draw bridge across the Atlantic Intracoastal 'Water way in Fort Lauderdale, Florida, to re quire that the draw open on signal. Pres ent regulations uiiow closed periot-s from November 15 through May 15 from 7 a.ra. to C p.m. during which the drew 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 oil March 15. 1950 (15 Fit 1401). and were amended on July 2, 1933 (13 FR 3702), October 23. 1955 (20 IR 8118). and October 20. 19i>6 (21 1;'R f.r-0-5). These regulations were Issued to case vo- FCDCRAl RCGISIfR, VOL 39, NO. 78--MONDAY", AHtlL 22, 1974