Document DzdB54m4XdO2q20oXo11e1eN

YET MORE LATA OH FVC PACKAGING REQUIRED Further data on PVC usage in food, drug and cosmetics containers and in medical devices was requested by the FDA on 22 April, with a deadline set for 21 June. The information required involved the extent of usage of PTC for different types of containers and container liners and the types of product; the vinyl chloride content of FVC used for such purposes, in cluding descriptions of the methods and extraction systems used for its determination; the rate and level of vinyl chloride extracted from such containers by various foods, drugs and cosmetics, including data derived after periods of storage; the rate and level of percutaneous absorption of vinyl chloride from cosmetics and devices in contact with skin or mucous membranes; the vinyl chloride content of various drug fluids after contact with FVC devices; and the effect on blood and tissues of vinyl chloride extracted from such devices inserted or implanted in the body. The FDA has already taken action against cosmetic products with vinyl chloride in the propellant', and the Environmental Protection Agency has taken similar action against pesticide aerosol products. An inter-agency task force has been formed to gather data on the overall effect of vinyl chloride on the total environment, and to initiate co-ordinated aotion to minimize this impact. The FDA has now apparently abandoned the idea of imposing limits on residual vinyl chloride monomer in FVC (BIERA Bull. 1974, .12> 237) but the end-test limit of 50 ppb in the contained food is still expected to be introduced. INDUSTRIAL EXPOSURE TO VTHYL CHLORIDE TO BE REDUCED The limitation of industrial exposure to vinyl chloride to a level un detectable by an accurate method sensitive to 1 + 0*5 ppm, was proposed on 10 May by the Occupational Health and Safety Administration (OHSA). This followed the issue on 5 April of an emergency temporary standard, which reduced the ceiling value set by OHSA for vinyl chloride exposure from 500 to 50 ppm (Federal Register 1974. 22* 12342). At the February hearing (BIBRA Bull. 1974i 22* 179)* evidence was SUCU CUllOv as posaibl The All T of Federal attempt tc Register and label-' and inter. Sub chap te. reported . filing of initial period sh 9165)- Cm 1 D.W. Ken" in the rt * lonitrileided purpose 5, 238). In m subjected to annulation will with a re ed. It is : of other 1ready been tainers and in eadline set usage of FVC types of OBes, ini for its faa such t^^^ived ab^^ition of or mucous after contact 1 chloride 3 with vinyl lency has taken jency task rinyl chloride 30 minimize limits on 37) but the d to be a level un^opoeed on 3A). This 4, which from 500 see was JT Z . O - 288 - presented by Professor C. Maltoni of the Istituto di Oncologia, Bologna, Italy, that haemangiosarcomas of the liver had. developed in animals exposed to vinyl chloride concentrations in the air as low as 250 ppm. No tumours hnd been seen at 50 ppm in this or in an earlier study (Torkelson et al. Am, ind. Hyg. Ass. J. 1961 , 22, 354); however, Professor Maltoni is now conducting a more comprehensive study which involves the exposure of 300 animals at the 50 ppm level (see also p.24S of this issue). OHSA concluded that although 50 ppm could not be regarded proven as safe for lifetime exposure, it was the lowest level that could be complied with immediately and was well below levels to which some workers were currently being exposed. The emergency standard (Part 1910, Title 29, Sec.1910.93q) applies to all areas and operations in which vinyl chloride is manufactured, reacted, handled, processed, released, repacked or stored, and requires weekly monitoring for at least 3 weeks to establish that concentrations do not exceed 50 ppm; thereafter, monthly monitoring is required. In all operations involving concentrations above 50 ppm, respirators or other breathing apparatus are required, and engineering or operational controls to reduce such concentrations to the permissible level must be introduced as quickly as possible. The standard will remain in effect for a maximum period of 6 months. COSMETICS REGULATIONS RECODED All regulations on cosmetics made under Title 21, Chapter I of the Code of Federal Regulations have been recoded under a new Subchapter G, in an attempt to provide greater clarity and convenience for the user (Federal Register 1974, 39, 10054), This brings together the regulations on packaging and labelling formerly under Part 1 of Subchapter A, the statements of policy and interpretation formerly under Part 3 of that subchapter, and the former Subchapter D, which included the recent regulations on voluntary filing of reported adverse reactions (BIBRA Bull. 1974, 13, 52). Because forms for the filing of adverse reactions would not become available until May 1974, the initial reporting period was deferred to January-June 1974. Reports for this period should he submitted to the FDA by 1 September 1974 (ibid 1974. 39, 9185). -%<* V> ll i z Y s f* A A % i" -;v5 "if.A NEWS OF BIBRA DR. D.W. KENT-J0NES, O.B.E. On behalf of the BIBRA staff, we congratulate our Vice-President, Dr. D.W. Kent--Jones, on the award of an O.B.E., for services to the food industry, in the recent Birthday Honours List. f? , jji `i; S* A 41 ,,i CUSAROSS 02788