Document ZVkOdVbLndgM24b4nvYdaRQL

137 3-78 Lead Paint 18,577 [124,121] ^OPRUcsrScope and application. this Part ISOS, tbe Consumer Freouct Safety Commission declare* that paint and atmflay surface-ooating materials for consumer use that coctalo lead or lead compounds and in which tbe lead content (calculated as lead metal) It in excess of C.OC percent of the weight of the total nonvolatile content of the paint or the weight of the dried paint fQm (which paint and similar surface-coating materials are referred to hereafter as "lead-contaialn* paint") are banned hazardous products under sections I and 9 of the Consumer Product Safety Act (CPSA). 15 D.B.C. 9057, 9051. (See Parts 1145.1 and 1145.3 for the Commisaion'i finding under section 90(d) of the Consumer Preduet Safety Aet <CPSA> that it Is in the public interest to regu late lead-containing paint and certain consumer products bearing such paint under the CPSA.) The following con sumer products are also declared to he banned hazardous products: (1)Toys and other article* Intended for use by chDdren that bear "lead-con taining paint" . (3) Furniture articles for consumer use that bear "lead-cootainJng paint". . <b) This ban applies to the products In tbe categories described In paragraph (a> of this section that are manufactured after February 97, 1978. and which are srrwaum products" as that ten Is de fined to section 1(a) (1) of the Consumer Product Safety Aet Accordingly, those Of the products described above that are customarily produced or distributed for sal* to or for use, consumption, or enjoy ment of consumer* to or around a house hold, In schools, la recreation, or other wise an covered by the regulation. Paints and coatings for motor vehicles and hosts are not Included within tbe scope of the ban because they are outside the statutory definition of "consumer prod uct". In addition to those products which are sold directly to consumers, tbe ban applies to products which are used or en joyed by consumers after sale, such as paints used In residences, schools, hospi tals, parts,'QaiJii'in'iili, and public bondings or tfher areas where consumers wfQ have direct access to tbe painted Consumer Product Safety Guide surface. <e) Tbe Commission has Issued the ban because it has found (1) that there is an unreasonable risk of lead poisoning in children associated with lead content of ever 048 percent tn paints and coatings to which children have access aM (2) that no feasible consumer product safety taadart, tinder the CPSA would ade quately protect tbe public from this risk. [H24.122J 11M11 Definition*. (a) Tbe definitions in section 9 of the Ocotumer Product Safety Aet (15 DS C. 9882) shall apply to this Part 1983. Q)> Tor purposes of this Part: (1) "Paint and other similar surface* coating materials" means a toiiit, sssmJMdj-or saber materiel, with or without a suspension of finely divided coloring matter, which changes to a solid film when a tUa layer Is applied to a metal wood, stone, paper, leather, cloth, plastic, or other sarface.-ThJs term does-not toetede printing Inks or those materials which actually become a part of the sub strate, soeh m tbe pigment In a plastic article, or those mstvirisli whleb are artaatip beaded to tbe substrate, each as fay.etoefcropiattag or oeramte glaring- <*> "lead-containing paint" means paint or other ^wHar surface coating materials containing lead or lead com pound* and to which the lead content (calculated as lead metal) is in excess of 4 percent by weight of the total noovdatfle content of the paint or the weight of the dried paint film. O) "Jbyi and other articles intended lor use by children" means those toys V and other articles which are intended to f be entrusted to or for use by ehfldrta. ' Tbh would hot include all articles to * which children might have access simply because they are present tn a household. M> Tumtture article" means those movable articles, li) used to support people or things: Oi> other functional or dsoarative furniture articles, including, bat not limited to, products such as beds, bookcases, chain, chests, tables, dressers, desks, pianos, eoasole telen- yVmi pis Tbe term "furniture article" does not include appliances, such 1303.2 124,122 GLD34884 18,577-2 Standards--^ns--Ifests 137 3-78 U ranges. refrigerators, dishwashers, clothes washer* and dryers, air condi tioners, humJdlfless. and dehumldiflexs; fixtures such as bathroom fixtures, builtis cabinets. chandeliers, windows, and doors; or household Items such as win dow shades. Venetian blinds, or Tali hangings and draperies. 11/24,123] ~3HJgIM~afte<ories of products listed ta paragraph (b) of this section are ex.empted from the scope of the ban estab lished by this Part 1303. provided: (!) That these products bear on the main panel of their label, in addition to any lebelug that may be otherwise re quired, the signal word "Warning" (un less some other signal word Is required! and the following statement: "Contains Lead. Dried Pilm of This Paint May He Harmful If fiaten or Chewed." tott) That these products also bear oo their label the following additional statement or its practical equivalent; Do not apply oo toy* and other children'* anielM. furniture. or interior surface* of any dwtutng or facility which may be occupied need by ehQdrcs. P not apply os exterior surface* of dwell ing waits. such u window sills, perches, stein, or railing*, to which chUlreo may he oomaoniy esyaaafl. Jteep nut of reach of ehDdres. If the statement required by the preceding paragraph (a) (21 (1) Is placed on a label pane! other than the main panel, the laoei statement required to be o the main panel by paragraph (a) (1) of this section shall contain the following additk>*jJ statement: "See other cau tions on------(insert Tide' or 'back', as appropriate) panti." (3) That the placement, conspicuousness, and contrast of the label statements required by this section (a) comply with the requirements of the Pederal Haz ardous Substances Act at If CPU 1500.121. HBpM the foflowtog products are ex empt from the scope of tbe ban estab lished hr this Part IMS, pewrkfed they eocntfr wttb the rwtrmeatg of paragrepb (a) of thb section: 1)1 Agrtadtttral asm tadurtria! oqttipment rcfinlsh coattnga. (2) - Industrial (and commercial) building and equipment maintenance coatings. Including traffle and aafety marking coatings. (3) Graph* art coatings tie., products marketed solely for application on bill boards, road slims, and citnflar uaes and for identification martix* tc Industrial buildings). M) Toocbup coatings for agricultural equipment, lawn and garden equipment, appHTL/*< (5) Catalysed coating* marketed aolely for use on radio-controlled model power^iiftraft. following products are exempt from the aeope of tbe ban established by Part 1363 (oo cautionary labeling is required): (1) Mirror* which art part of furni ture articles to the extent that they bear lead-containing backing paint. (2) Artists' paints and related matemis. [13 (3) Meta! furniture articles (bat hot metal children's furniture) bearing factory-applied dead) coaftnga, (Sec. 3(c). * SUL 1211 (11 UJBjfc *H*e>U [As amended, 43 F.Jt. 8515, March 2, 19780 ^43 F.R. 8514, 3-2-78. StrxfMARY: The Commission amends its banning regulation on furniture bearing lead-containing paint to exempt metal furniture articles (but not metal children's furniture) bearing 124,123 16 Cm 1303.3 factory-applied coatings from.the fur niture banned by the regulation. The Commission is Issuing this amendment because of data Indicating that fac tory-applied coatings from metal fur niture do oot chip or chalk and are. therefore. Inaccessible for Ingestion by children. Tbe National Paint and Q 1974 Commerce Clearing Hoose. Inc. .v- v -V_.; GL034885 Lead Paint 18,577-3 DATE: The amendment it effective March 2. 1978. FOR FURTHER INFORMATION CONTACT: Charles Jacobson. Directorate for Compliance and Enforcement. Conturner Product Safety Commission. Washington. D.C. 20207. 301-4924400. SUPPLEMENTARY INFORMATION: Ba c k g r o u n d On January 12. 1978. the Commis sion published In the Fe d d u i Reg is t er (43 FR 1804) a proposed amend ment to its final ban on lead-contain ing paint (defined as paint containing more than 0.08 percent lead by weight) and toys and furniture bear ing such paint (42 FR 44192 (16 CFR Part 1303)). The proposed amendment would exempt metal furniture articles (but not meul children's furniture) bearing factory-applied coatings from the regulation banning furniture under Part 1303. The amendment was proposed In re sponse to a petition dated October 7. 1977 (CP 78-1). from the National Paint and Coatings Association (NPCA) seeking the exclusion of metal furniture (but not metal children's furniture) bearing factory-applied lead coatings from the provisions of Part 1303. In its petition NPCA contended that coatings applied to metal furni ture at the factory do not present the hazard of lead poisoning in children resulting from the ingestion of avail able lead-paint chips that Part 1303 was designed to address. The petition er staled that metal furniture coatings are inaccessible to children because of their resistance to chipping and peeltag due to the hardness of the coat ings and their strong adhesion to the metal substrate. NPCA submitted in formation and test data in support of iU petition, and at a November 2,1977, public meeting on the petition, NPCA demonstrated mechanical perfor mance tests which measure the hard ness, adhesion, and resistance to Impact of metal furniture coatings. Consumer Product Safety Guide Based on the data submitted by NPCA and other information available to the Commission, the Commission granted the petition and proposed the amendment dted above. <42 FR 44192.) The grounds for the proposed amendment are set out to the proposal document and will only be summarized here. Basically, the Commission noted that the mechanical stress perfor mance testa conducted by NPCA at the November L 1977, public meeting strongly suggest that factory-applied metal furniture coatings are much harder than ordinary interior or exte rior surface coatings applied to walls or woodwork, are resistant to chipping and cracking, and strongly adhere to the metal substrate to which they are applied The Commission also consid ered the views of two medical experts. Dr. Julian Chisolm and Dr. J. W. Sayre, both of whom were proponents of the proposition to baa residential paint containing more than 0.06 per cent lead, but who to letters to NPCA expressed their support for an exemp tion for metal furniture. (The letters are on fiJe at the Commiation't Office of the Secretary.) Is addition, the Commission noted that a review of the scientific literature on lead poisoning did not yield a single reference to fac tory-applied metal furniture costings as being responsible for elevated blood lead levels or lead poisoning of chil dren. Finally, the Commission consid ered data on the economic effects of the elimination of lead from metal furniture coalings which Indicated that certain deep tone colors may be difficult to obtain with son-leaded pig ments and that without lead, the price of metal furniture coatings would rise moderately, eauxing a small increase in the price* of some metal furniture. RcsroKS* to Cmaaorts The Commission received twentytwo comments on the proposed amendment to exempt metal furniture (but not metal children's furniture) bearing factory-applied coatings from the lead-containing paint ban. Fart 1383. The commecters Included 11 concerned citizens, 7 manufacturers, 1 county agency, and 1 trade associ ation*. The comments from the concerned 16 CFR 1303%3 124,123 ./vVf" GLD3 7-4 Standards---Bans--itests 337 3-76 t^^(continued) citizens a* well a* the county aypncy requested that an exemption for metal furniture not be granted. Several of these coismenters expressed the view that the risk of lead poisoning In chil dren would be Increased as a result of the exemption. Two of the commenter* also stated that If any exemp tion lor metal furniture articles was granted, a warning label on the exempted articles should be required. The Commission notes that none of the commenter* who expressed disap proval of the proposed exemption sup plied any data to support their views. Based upon the data referenced above and discussed in the proposal docu ment. the Commission believes that factory-applied coatings for metal fur niture will not pose a significant hazard to young children because the hardness of the coatings, their adher ence to the metal substrate, and their resistance to chipping appear to make it difficult for a child to obtain such coatings. Because the Commission does not believe there is a significant hazard from such furniture, it has not required any warning labels on metal furniture. The Commission empha sizes that it expects that reasonable manufacturing practices will result in metal furniture whose coatings are hard, durable, and tightly bound to the metal substrate. The Commission points out. however, that should it find instances where these factory-ap plied coatings containing lead chip, peel, chalk, or otherwise become easily available for removal and ingestion by children, it may consider Individual regulatory action. The comments from the manufac turers, which included 6 metal furni ture manufacturers and 3 coating* manufacturer*, uniformly supported the proposed exemption. One manu facturer noted that the paint on metal furniture is only a few mUi in thick ness and very hard and that it is diffi cult to remove even with the best of paint-removing devices. Another man ufacturer stated that the pre-painting preparation of the metal substrate gives adhesion qualities which mini mize any chipping and cracking possi bilities. Several manufacturers empha sised that lead chromate pigments are *24,123 16 CFR 1303.3 Inexpensive when compared to substi tute pigments. A commenter representing an associ ation of manufacturers, retailers, and wholesalers of office furniture also supported the proposed exemption, noting that the standards of applica tion in the office metal furniture in dustry are high and that the same testing procedure* demonstrated by NFCA at the public meeting are uti lised. A trade association representing toy manufacturers and another associ ation representing the manufacturer* of Juvenile furniture requested that children's metal furniture be included within any final exemption for the same reason* that adult metal fundtun had been included in the pro posed exemption. The Commission decline* to broaden the aeope of the proposal to include children's furniture. The Commission Dote that since 1979 the coatings on toys and other articles Intended lor u*e by children, which includes furni ture, have been subject to a lead limit of 64 percept free 17 FR $329; Id CFR 190O.17<aX6Xil. Po t s --CoattniB on adoH furniture win first become subject to a lead limit on Feb ruary tt. im ua TK 441*3; it CPU Fart 1369). The Commission sees no reason for abolishing lead-paint restrictions for children** furniture at this time when manufacturers of such articles have been conforming to a lead limit for the past several year* which virtually eliminates the use of lead as a pig ment. In declining to broaden the cope of the proposal, the Commission that although the poesfbfi fty of children's metal furniture chip ping or flaking may be remote, the dose proxim/ty of chfldres to their own furniture makes even this pewtiWUty an tmnecesaary risk. Zn this regard the Commission Dotes that Dr. Sayre in his letter to KPCA on CP 76I, Doted above, stated: "Neither have we found many children who gnaw much furniture betides (Mr hi&%- ohotf* end cribs.M HRmphtste added.} m* letter Is dated October 2S. 1977 and it oo fOe at the Commission's Office of the Secretary.* Xs addition, children often bang their furniture 1971, Commerce Gearing Ho c k , lot f I f GLD3488? 137 3-78 Lead Paint 18,577-5 continued) with other' object* or into other ob jects. thereby Incresslm the chance that the coating* may chip. The Com mission also points out that the Na tional Academy of Sciences (NAS) in a report submitted to the Commission entitled "Recommendations for the Prevention of Zcad Poisoning in Chil dren*' specifically recommended that the lead content of paints on ebDdrefi's articles, tndodtog toys and fur niture, be severely restricted (NAS Report, p. 10.) SbrvxjtoncDrraL CozcsamanoKS The Commission has considered the potential environmental impacts of an exemption for metal furniture from a ban on lead-containing paint, toys, and furniture in the Final Environ mental Impact Statement on Lead Content in Paint, dated Hay 3. 1377. (See. especially, pates I-B-15, n-A-4t, in-8, and m-n of the final state ment.). Nora--The svadabOttr of the nasi impact statement ni announced by the Council on E&vlrorunentai Quality in the Pmau Rsty tms on June it. 1977 til PR 39048). The potential ervU-oaaxnuJ ffeti of the ex clusion of metal Jumltuxt wrt tlao inclos ed to the draft statement on lead contest to paint which v made ansafete for public comment by announcement to the Psaouu. ftsossm os February- 4.2977. (43 JR 6t?9.) Therefore, the Commission believes that there is no need for any further environmental review of this exemp tion. COWCLtSlOW In determining whether a specific risk of injury U 'unreasonable" and therefore, properly the subject of a banning regulation, the Commission generally Ulanovs the probability that the risk will result in ham and the gravity of the ham against a rule's effect oo the product's utility, cost, and availability to the consumer. (See BA. Rep. No. P3-X183. %U Cong.. 3d Seas.. 1972. p. 39.) In this Instance the Commission be lieves. based upon the data summa rized above and after a review of the public comments, that the probability that factory-applied coatings oo metal furniture wOl result In harm is remote Consumer Product Safety Guide because the hardness of the oostings and their nshtanoe to chipping makes ft unlikely that the coatings will be re moved and ingested by children. In ad dition, the Coramlssfop has Indicated that should it find tostannes where factory-applied lead coating* for metal furniture chip. peel, chalk, or other wise become easily available for re moval and ingestion by children, it may consider individual regulatory action. The Commission also notes, after a review of information on the economic effects of the elimination of lead pig ments from these factor?-applied coal ings, that such elimination may have an adverse effect on the product's cost and utility. The Commisrioc finds that the available data does not .indicate that metal furniture (exclusive of metal children* furniture) bearing factoryapplied coating presents an unreason able risk of injury from lead poisoning in chbdren. Therefore, the Commis sion concludes that a ben of such metal furniture is not reasonably nec essary to eliminate a risk of injury as sociated with the painted furniture and has decided to issue the amend ment u set forth below. Faofosuu. Section Pit) of the Consumer Prodnet Balety Act, 13 V&-C. 30M<e>. pro vides that when an amendment to a causvmtT product safety rule involves a material change the procedures In sections 7 and 9 apply. It is the Com mission's view that the amendment issued below does not involve a materi al change to the lead-containing paint ban because ft does pot affect the basic purpose and provisions of the baa Therefore.' the provisions of sec tion 7 and 9 (aWd) do not apply. The Commission believes that the Informs) rulemaking procedures of the Admin istrative Procedure Act (AFA), 3 VAC. 333. do apply. The Commission has decided to make this amendment effective Immediately March 2. 1978. so that it may be In effect before or at the same time as the lead-eontalning paint U* In this regard the Commis sion notes that subsection <d) of 1353 of the AFA excepts substantive rules which grant at recognise an exeap- 16 OR* 1303.3 % 24,123 GID34888 16,578 Standards--Bans--Tests 137 3-78 [1124,1243 1303.4 Banned bourdon* product*. The fohovlng consumer product, manufactured tiler February 37, 3076. unless exempted by 11306.3. ere burned hazardous products (eee the definitions ta section 19034): <*) paint and other similar surfacemattnf materials which are "lead-con taining: paint.'' (b) Toys and other articles intended for use by ehDdren that bear *1eadconUining paint." (c) rumJturt articles that bear "leadcontaining paint." [124,125] i { 1303.5 Ftodias*. ta) The degree and nature of the risk of injury. (1) The Commission finds that the risk of injury which ^ regulation ^(continued) tion from the 90-day delayed effective date requirement Accordingly, pursuant to provisions of the Consumer Produet Safety Act tsee. 0(e), 96 8tat 1119; 15 TJJB.C. 9058(e)). and the Administrative Pro cedure Ad. 8 UA.C. 559. the Commis sion amends 18 CFR 19034(c) by 124,123 16 CFR 1303.3 adding a new subparagraph (I) as fol lows: *a*a* Effective dale: 7he amendment Is ef fective March 9.3979. Dated February 37.1679 6am E. Dmnt. Acting Secretary, Consumer Prodacf Safety Commission. GL03A889 I^ad Paint 18,579 Is designed to eliminate or reduce Is lead poisoning in children. The adverse ef fects of this poisoning in children can cause a range of disorders such as hy peractivity, sieved learning ability, withdrawal, blindness, and even death. The final Environmental Impact State ment on Lead in Paint which it on file with the President's Council on Envi ronmental Quality (and available lor in spection in the Office of the Secretary) eontains in Appendix A a detailed dis cussion of the health effects of lead to paint. These effects will only be sum marized here. (2)laad is a cumulative toxic heavy metal which, in humans, exerts its effects on the renal, hematopoietic, and nervous systems, hewer concepts Indicate that there are three stages to childhood lead poisoning. The adverse health effects In the first stage are not clinically present but metabolic changes can be observed. During the second stage or symptomatic stage such symptoms as loss of appetite, vomiting, apathy, drowsiness, and Ina bility to coordinate voluntary muscle movements occur. The aftereffects of this stage include seizure disorders as well as various behavioral and functional dis orders which are often included under the heading of minimal brain dysfunc tion. Studies suggest that this syndrome may include hyperactivity. Impulsive behavior, prolonged reaction time, perceptual disorders and slowed learning ability. The advene health effects of the third stage may be permanent and can include blindness, mental retardation, behavior disorders, and death. (3) The Commission notes that chil dren with pica are of special concern with regard to lead poisoning. Plea, the repetitive ingestion of nonfood sub stances, occurs in 50 percent of children between the ages of oce and three, and studies indicate that at this age lead is absorbed more rapidly than lead Is ab sorbed Is adults. Pica for paint Is believed to be episodic and can occur 2 to 3 times a week. (4) Tbe Commission also notes that there are no reports of Injuries caused by lead paint poisoning in tbe Commfcalon's National Electronic Injury Surveillance System (NEZSS) data, which reflect hos pital emergency room treatment. Lead paint poisoning? mult from a chronic hazard rather than from an acute haz ard of the type generally treated to emer gency rooms; and NElfiS reporting, therefore, does not reflect this type of Consumer Product Safety Guide chronic hazard or Injuries. (3) former 7J.fi. Eurgece-General Jesse L- Steinfeld. however, estimated In 1371 that 400,000 pre-school American children have elevated body lead bur dens. The Nations] Bureau erf Standards In 3072 estimated that dbifiOb young children have unduly high lead blood content. (b) Products eubfect to this bon. <i) The products banned by this rule are listed in section 1303.4. (2) Tbe term -paint" comprises a va riety of coating materials such as Interior and exterior household paints, varnishes, lacquers, stains, enamds. primers, and similar coatings formulated for use os various surfaces. Baaed on 3071 data, the Commission estimates that over 400 mil lion gallons of paint a year valued at ap proximately $3.5 billion could potentially be subject to this rule. (3) AH products commonly known as toys and other articles Intended tor the use erf children are subject to this rule. Tbe categories of products within this classification are numerous and include hems and equipment for play, amuse ment, education, physical fitness, and care of children. Retail sales In 3976 of products considered to be toys or other articles Intended for use of children are estimated at around 44 billion. (4) for tbe purposes of this rule, fur niture articles are certain movable arti cles used to support people or things or other functional or decorative furniture articles such as oooebes, beds, tables, chain, chests, and the like. Appliances Tid yhntiT equipment, household fix tures, and certain other household Items such as window shades, hbnds. wall hangings, and tbe like art not Included within the definition of furniture. The regulation applies to furniture for use in household*, acboofe. to recreation, or otherwise, 3fc 1972, the valw at shipments erf Items of furnituresuch as those named above was as fa&ows: wood boosrhoid furniture$2,716 mSUon; metalheosehold furniture $358 aflbon; wood television and radio cabinets $293 mfltion; and $190 million for other household furniture made of plastic, reed and rattan. (Not In cluded to the above are some $2 billion worth of upholstered furniture and $300 million In eoavertftle sofas, chair beds and studio couches.) (c) Need o/ the public /or Ike products end effects of the rule on their utility, cost, and eveUeUHtf. (l) Tbe public need for paints of various types and lor furniture and other articles fc snobstan- 16 CEH 1303.5 124,125 GL 034890 18,580 Standards-Bans--Tests 133 1-78 tial and well established. The Commis sion finds that the need of the public for paint containing more than 0.06 per cent lead or for the affected products that are coated with materials containtug more than 0.00 percent lead is lim ited The Commission has determined that there are products containing more than the 0.06 percent level of lead which meet a public need and for which sub stitutes are either not available or are not sufficiently effective and to which access by children to the coaUnps or the surfaces to which they are applied is un likely. Accordingly, these products have been specifically exempted from the scope of the regulation in 11303.3. (2) The Commission finds that the ef fects of this rule on tbe cost, utility, and availability of paints and painted articles will he small The Commission cotes that over 3$ percent of latex-based and nearly 70 percent of oil-based paints have lead levels at Dr below the level set hy Part 1303. <i> Costs. The Commission estimates that tbe added costs to the consumer for paints affected by this rule will not ex ceed 5 to 10 cents per gallon. Costs to consumers for furniture and for toys and other articles intended for the use of children are not expected to increase as the result of compliance with the reg ulation. <ii> Vtiiilv- The Commission finds that for water-based or latex paints and coat ings subject to this rule, reducing the amount of allowable lead to 0.06 per cent will not have adverse effects on their utility. For certain solvent-thinned coatings, however, lead driers will have to he replaced by non-lead driers such as aireoaium to comply with the 0.06 percent level <Driers are not used is latex paints;. An impact on the paint in dustry may mult because current noalead driers may not dry satisfactorily in low temperatures or high humidity con ditions, and ao the painting industry in some areas at certain times of the year may suffer a reduction of effective paint ing time. Uii) AtttUabtbty. Substitutes at com parable prices are available for paints and for products banned by this rule. The Commission believes that tbe reduc tion of lead to a level of 0.06 percent will not affect the availability of waterbased or latex paints. Sales of such coatings currently exceed sales of sol trend toward increased use of waterbased paints may be accelerated some what by tbe effects of the ban. (d> AHenuxtoes. <1) The Commission has considered other means of achieving the objective of this rule, but has found none that would cause less disruption or dislocation of manufacturing and other commercial practices, consistent with public health and safety. (2) Tht Commission estimates that Ihh ban may, because of testing costs and tbe necessity for improved housekeeping practices to the manufacture of paint and similar surface-coating materials to prevent lead contamination, have some relatively minor adverse effect on indi vidual firms within some markets. <S> The Commission, however, finds that competition will not be adversely affected by this rule. Although costs of reformulation and testing may be rela tively higher for small manufacturers than Urge manufacturers, these costs are not so onerous as to lead to greater concentration in the industry. The period of time before the effective date is suf ficient to minimise problems of compli ance with the rule. <4; The reduction of the permissible level of lead to paint will affect paint manufacturers, raw materials suppliers, professional and non-professional paint ers. and manufacturers of furniture and children's articles. For those producers of paint which an already subject to the regulations under the Federal Hazardous Substances Act <FBSA>. the impact of this CPSA ban wfQ involve only a change to non-lead driers since lead pigments are precluded from practical use under the percent lead restriction now in effect under the FB&A <16 CPU 1500.17 <a><6;. The manufacturers of some painted furniture who were not affected by the 0.5 percent limit under the FESA may now be. if they use lead pigments or driers. Producers of children's articles who were subject to the Ofi percent FSSA limit will have to ensure that the paint they use conforms to tbe 0.06 percent level. te> Conchuten. Tbe Commission finds that this rule, including its effective date, is reasonably necessary to eliminate or reduce the unreasonable risk of lead, poisoning of young children that is as sociated with tbe banned products which are described to 11303.4 and that pro vent-based coatings, and because of the drying problem mentioned above, tbe mulgation of the rule is in the public in terest. 116 CFR Part 1304 begins on page 18,583.3 K24,125 16 CFR 1303.5 I97, Commert* Clearing House, Inc 266-.1-83 Hazardous Substances 20,047 container* (or such substances shall beer the following libeling: (a> When substances are produced that meet the definition of highly toxic in HSM.3(>(1), the signs} word "Dan ger" and the statement ot hasard "Potsonousgaxw formed when used to ex tinguish flame or on contact with beat** are required labeling. (b) When substances are produced that meet the definition of toxic toI l500.3(cUg), the rigaa! word "Caution** or "Warning" and the statement of haz ard "Dangtrous gas formed when used to extinguish flame or on contact with beat" art required labeling. <c> Regardless of whether paragraph (a) or <b) of this section applies, any substance or mixture of substances la beled for use as a fire extinguisher that, if applied to an electrical fire, would subject the user to the likelihood of elec trical shock `shall be conspicuously la beled "Caution: Do not use on electrical wires." (d> The statements specified in para graphs ta>. <b), and <c) of this section shall be In addition to any other that may he required under the act All such substances or mixtures of substances shall also bear the additions) statements ~Use in an enclosed place may be fatal" and "Do not enter ares until well venti lated and all odor of chemical has disappeared.'4 C1[26,LL7J (1) Sdixtum that are intended pri marily for application to interior ma sonry walls, floors, etc., as a water repellant treatment and that are "extremely flammable** within the meaning of sec tion 3(1) of the act (repeated in UbOOA<b> U0>>. (3) Carbon tetrachloride and mixtures containing it (Including carbon tetrachloride and mixtures containing it used in fire extinguishers), excluding un avoidable manufacturing residues of car bon tetrachloride In other chemicals that under reasonably foreseeable conditions of uss do not result in an atmospheric concentration of carbon tetrachloride greater than 10 parts per million. <5) Ptreworks devices Intended to pro* duce audible effects (including but not limited to cherry bombs, M-40 salutes, silver salutes, and other large fire crackers, aerial bombs, and other fire works designed to produce audible effects, and including kits and components in tended to produce such fireworks) if the audible effect Is produced by a charge of more than 3 grains of pyrotechnic com position: except that this provision shall not apply to such fireworks devices if all of the following conditions are met: (i> Such fireworks devices are distrib uted to farmers, ranchers, or growers through a wildlife management program administered by the VS. Department of the Interior (or by equivalent State or local government agencies); and (ill 8ucb distribution is in response to a written application describing the wildlife management problem that re quires use of such devices, is of a quantity bo greater than required to control the problem described, and U where other means of control are unavailable or inadequate. Bee also i500.J<(bX7); !JO0.1?(X) "d (9). lS00.3(xr)>; IS00.WUX2); and Pan 1507]. ant'd hazardtu taWutire*. ^Bp^Jnder the authority of section 3(q)(lKB) of the act, the Oommtalon declares as banned hazardous substances the following articles because they pos sess such a degrae or nature of hasard that adequate cautionary labeling can not be written and the public health and safety ean be served only to keep ing such articles out of interstate commerce: (4) liquid drain cleaners containing 10 percent or more to weight of sodium and/or potassium hydroxide; except that this subparagraph shall not apply to such hquid drain cleaners if packaged in ac cordance with a standard for special parkaging of such articles promulgated under the Poison Prevention Packaging Act Of 1970 (Pub. L. 91-601,64 Slat. 167074 (15 U.B.C. 1471-76) >. {The next page is 20,047-3.] Consumer Product Safety Guide ^BVSf^500.17 1126,117 1 S$S?7H223?'r:<:';v X GL03A69Z 266 1-83 Hazardous Substances 20,047-3 <) Products containing soluble cyfclde Milts, excluding un*voidable manu facturing residues of cyanide salts la other chemicals that under reasonable Ad foreseeable conditions of use will pot tfcurit to s .concentration of cyanide treater than 35 parts per mSShon. Any paint or other similar surface-coating material intended, or packaged In a form sultahk, for use to or-around the household that: Caution: R't U500.!7tiXiiM/ Us beta s37F.K. 1607b. August JO, I972.-CCH (A) Ir shipped in Interstate commerce after December 31. 1973. and contains lead compounds of which the lead con tent (calculated as the metal) is to excess of 0.05 percent of the total weight of the contained solids or dried paint film; or CB> Is shipped to interstate commerce after December 31, 2973, and contains lead compounds of which the lead con tent^calculated as the metal) is to excess of 0.5 percent of the total weight of the contained solids or dried paint film. (C) [Reserved} (D) The provisions of paragraph (a) <e> <i) of this section do not apply to ar* *ti*U' paints arid related materials. Cl) Any toy or other article intended for use by children that: Caution: Keg. iJSO&JTtO/GKA) Us Un stayed. 37FJt 16076. August 16.1971-CCH (A) Is shipped to interstate commerce after December 31, 1973. and heart any paint or other aimilar sttrfsce-coattrg' material containing lead compounds of which the lead content (calculated as the metal) is to exoeet of 0.06 percent of the total weight of the contained abtifi* or dried paint film; or <B> Is shipped to Interstate commerce after December 31. 1972, and bean any paint or other similar surface-coating material containing lead compounds of which the lead content (calculated as the metal) is to excess of 9.5 percent of the total weight of the contained solids or dried paint film. [23 JMU fitoee the Commission has issued comprehensive regulations for lead-contatotog paint and certain consumer products bearing such paint at the 9.06 percent level under the consumer Prod uct Safety Act (see 16 CFR Part 1393), subparagraphs 0) and (ii) of section 1500.17(a) (6) are revoked as to the sub ject products manufactured after Feb ruary 27, 1973. This revocation is conditional upon Part 1303 continuing in full force and effect. (7) Oeneral-ttse garments containing asbestos (other than garments having a bona fide application for personal pro tection against thermal injury and so constructed that the asbestos fiber* will not become airborne under reasonably foreseeable conditions of use). IV <6) Firecrackers designed to produce audible effects. if the audible effect is produced by a charge of more than 50 mflligrams (.777 grains) of pyrotechnic composition (not including firecrackers included as components of a rocket), aerial bombs, and devices that may be confused with candy or other foods, such as'"dragon eggs." and "cracker bafis" (also known as "bafi-type caps**). and toeluding Idt* and components intended to product such fireworks except such derices which meet afi of the following conditions: (1) The fireworks devices are distrib uted to farmers, ranchera or fcrowen through awildlife management program administered by the VS Department of Interior <or tor equivalent state or local governmental agencies); and <U) feueh distribution la to response to a written application describing the wild life management problem that require* use of such devices, is of a quantity no greater than required to control the problem described, and Is where other means of control is unavailable or inade quate. {See sfco 1300.I7UX3) tod ($)]. (9) All fireworks devices, other than firecrackers. Including kite and compo- *3see footnotes 1 and 2 at end of 127,550. [23See footnote at end of 126,117. Consumer Product fes/cty Guide 16 CFR 1500.17 126,117 GLD3*8q3 -crueu joctras--.Labels--Bans' 266 1*83 upnis mlendf-d ip produce such fire works. hot oihcrwisf banned under ihe act. that do not comply with the applicable requirements of Part 1507 of this chapter, except fireworks de vices whjch meet all the following con ditions: <i> The fireworks devices are distrib uted to farmers, ranchers, or growers through a wildlife management pro gram administered b.v theU.S Depart ment of the Interior (or by equivalent State or local government agencies): and -. < 11 > 'Such distribution Is in response to a written application describing the wildlife management problem that re quires use of such devices, is of a quan tity no greater than required to con trol the problem described, and is where other means of control is un available or inadequate. |Stt also 1500.17(a)(3) and (8)]. KO <101 Self-pressurized products in tended r suitable fee household use that contain vinyl chloride monomer, as an ingredient or in the propel-lani" manufactured or Jmpcrted on or after October?. 1974. [38 r.R. 4666, effective Kar. 22, 2973; 38 r.R. 27514, ef fective Dec. 3, 1673; 38 F.R. 35302, effective Sec. 27, 2973; 39 r.R. 17435, effec tive date of June 17, 2974 stayed by the filing of ob jections; amended 33 r.R. 30212, effective Oct. 7, 1974; 39 F.R. 42902, effec tive Dec. 9, 1974; 41 r.R. 22931, June 8, 1976; 42 F.R. 44202, effective Feb. 28, 1978; 43 r.R. 12308, March 24, 1878.D ^^See footnotes 2 and 2 at end of *27,550. ^42 r.R, 44201, 9-1-77. SUMMARY: The Commisrioc issues an amendment partially revoking a regula tion under the Federal Basardou* 8ubstances Act (FHSA) declaring certain lead-containing paint, and toy$ or other articles Intended for use by children bearing such paint, to be banned hat* ardous substances. The amendment pro vides that the FHSA regulation will not be applicable to products manufactured after February 27. 1971. but wifi continue to apply to products manufactured on and prior to that date. This amendment Is necessary because elsewhere to this Issue of the Fxanai R*g is t s * the Oommission issues a new regulation under the Consumer Product Safeqr Act for certain lead-containing paint and toys and furniture bearing such paint manu factured after February 21. 1*76. EFFECTIVE DATS: The amendment issued below i elective February 21, mg. FOR FURTHER INFORMATION CON TACT: Charles M. Jacobson, Directorate for Compliance and Enforcement, Con sumer Product Safety Commission. *26,117 16 CFR 1500.17 Washington, D.C. 90207. telephone soi-m-woo, SUPPLEMENTARY INFORMATION: On August io, 1976, by publication of a notice in the Fnux Recurs* <41 PR 83637). the Commission proposed a rule under section 8 of the Consumer Prod uct Safety Act <CPSA>, 1$ tTA.C. 2057, declaring the foliowing to be banned hazardous products: (1) Lead-contain ing paint and similar surface-costing materials containing more than a tale level of lead, (2) toys and other articles Intended for use by children bearing leadcontaining paint or other similar surfacecoating materials containing more than a safe level of lead, and (3) articles of furniture bearing lead-containing paint or other similar surface-coating mate rials containing more than a safe level of lead. At the same time the Commission proposed to revoke the existing regula tion (26 CFR lKU7<a><e>> under the Federal Hazardous Substances Act (FB6A), 15 UA.C. 1261-1274. relating to lead-containing paint and toys and other articles intended for use by chil dren, bearing such paint, when the final CPSA harming regulation is Issued. The determination of a safe level of lead In paint was made by the Co bu x Os - 1963. Commerce Clearing House, lac. GL034894 Hazardous Substances 20,049 ion to accordance with separate proiiny under the I'ead-Baaed rant Poisoning Prevention Aet (LBFFPA) (42 XJJB.C. 4601 tv mq >, as amended (Pub. h 94-317). In the pn>nAi Rtesm of February 16. 1977 (42 PR 94M). the Commission announced Its dedsSoe that available scientific information it toguffldeat to establish that a level of lead in paint above 0.06 percent big not over fli percent is safe. A final CPSA rule incorporating this determination and im plementing the proposed ban appears elsewhere in this part of the Fnrui Racism (we PR Doe. 77-2M72, supra). The CoamiasSoD 1* amending 16 CPR i5M.l?(a>), which war bsued under the p h s a , to prevent an unnecessary dupScation of regulation* sow that final CPSA lead-to-paint rules are beta* issued at 16 CPR Part 1303. The Oocomlstioc has decided not to revoke 16 CFR 1500J7U) (6) entirely as proposed, ao that products manufactured before the effective date of the CPSA ban wSt still be subject to a lead limit Currently. 16 CPR 1600.17(a) (6) declares as banned hazardous substances any paint or other surfaee-coatiar material that )e*d compounds in which the lead content (calculated as lead metal) Is in excess of 0.5 percent of the'total weight of the contained solids or dried paint film. Section 1500.17(a)(6) also de clares as banned hazardous substances any toy or other article intended for use by children that bears such paint or Ayf.tiny iraterial Section 1500.17'aU6) also contains certain provisions (subdivisions <iKA> and 00 (A)) that were stayed a* a mult of objections filed pursuant to section 741(e) of the federal Pood. Drue, and Cosmetic Act <21 V.C. 871(e)). The stayed provisions would have lowered the A percent permitted level of lead to 0.06 percent. Thus, only the 0.5 percent level prescribed by 11500.17(a) (6) is in effect (8ee Ps mu o . Racism documents of Amt 10.1972 (37 PR 19076),December 37.1973 (U PR 35302). and December 9. 1974 09 PR 42902).) The CPSA banning regulation appear ing elsewhere in this pan of the Pk b o j l Consumer Prodpet Safety Guide Bitsm (see PR Doe. 77-25472) indudes the exemption lor artists' paint presently contained ta 11500.17(a)(6). The CPSA regulation also disposes of all outstanding exemption proposals and petitions to amend 11500.17(a) (6). The Commission points out that the sole purpose of this amendment is to pre vent an unnecessary duplication of reg ulations. Therefore, the amendment to partially revoke 16 CPR 1500.17(a) (6) is conditional upon Part 1303 continuing ta full force and effect. If. at time, any requirement of Part 1303 relating to products within the scope of 16 CPR 1500.17(a) (6) is stayed, revoked, or set aside by Judicial cr other action, the amendment partially 'revoking 16 CPR 1500.17(a)(6) is withdrawn, and a Pxxui Racism notice win be issued re instating the appropriate portions of 16 CPR 1500.17(a) It). AwtsmtEKT Accordingly, pursuant to provisions of the federal Hazardous Substances Act (sec. 2 <f) (1) (A), (a). 74 Stat 373. *74. as amended by 90 met 1304-1305; (15 VS.C. 1261 (f)(1) (A),. (q and the federal Ptiod, Drug and Cosmetic Act (section 701 (e>, <f>. <g), 52 Btat 1055. 1056, as amended 76 mat 915. 72 &tat 946; (21 US.C.371 ()CfKg))) and un der authority vested in tie Commission by the Consumer Product Safety Act <mc . 96(a), 96 Stet 2331; 25 VAC.' 3079 (a)), the CoaBsbdm amends 26 cn Part 1560.17(a) () by adfftag a new subparagraph (IB) as follows: Effective date: The amendment is ef fective February 23.2979. Dated: August 26.1977. Rrm,up Z. Karrs, Secretary, Ooasmaer Product Safety Commission. 16 CFR 1500.17 126/117 GLD34895 ..VX" Standards--Labels--Bans 12306, 3-2b-78. SUMMARY: The Commission reissues a regulation classifying any household substance in a self-pressurized contain er containing vinyl chloride monomer ft* ft "banned hazardous substance" under the Federal Hazardous Sub stances Act The Commission believes thftt there to ample scientific evidence to establish the carcinogenicity of vinyl chloride monomer by inhalation and to demonstrate that human expo sure to vinyl chloride monomer can result in a rare form of liver eanoer. The Commission to reissuing this regu lation on a prospective basis, a* of tbe date of the original ban (October 7, 1074), because that original retroactive ban eras aet aside for failure to hold a hearing on objections to the retroac tive effect of the regulation and be cause retroactive application of the regulation to no longer necessary- DATES: The effective date of the rule to June 22.1078 Tbe rule to applicable to products which are manufactured or imported on or after October 7, 1074. Any written objections must be received by April 24.1078. FOR FURTHER INFORMATION CONTACT: Charles M. Jacobson, Consumer Product Safety Commission, Direc torate for Compliance and Enforce ment. Division of Regulatory Man agement, Washington, D.C. 20207, 201-402-8400. SUPPLEMENTARY INFORMATION: Bs c x c j l o p k p On August 21.1074 tbe Commission published in the FXo d u l Rsetfnx 29 PR 20112, ft final regulation pursuant to section KqXlXB) of the Federal Hazardous Substances Act (FHSA), 10 VS.C. 1281 (q XIXB). declaring any self-pressurised products intended or suitable for household use that con tain vinyl chloride monomer as as in gredient or in the propellant to be "barmed hazardous substances'* (tbe propoaed regulation was published in the Fbh d u u . Racism on May 23.1674 (29 YR 18115)). Tbe Commission took that action because of scientific stud ies tbe death of industrial workers from a rare form of liver cancer to vinyl chloride exposure and because of certain animal studies fur 1(26,117 16 CFR 1500.17 ther indicating the carcinogenicity of Tiny) chloride monomer. In that same document the Commission declined to exercise any discretion, which tt might have had under the FHSA. to make It* banning order prospective only, thus requiring repurchase of products al ready distributed under tbe provisions of section 15 of the FHSA (15 U.S.C. 1274). That document also provided, as to required for the issuance of regula tions pursuant to section KqXlXB) of the FHSA. that the procedures fur ru lemaking under section 701(e) of the Federal Food. Drug and Cosmetic Act would govern and that adversely af fected persons could Hie objections and requests for a public ,*"r within 20 days of the publication of the Commission's order. Four statement* containing objec tions and request* for a public hearing were received by tbe Commission. Tbe objection* filed focused primarily on the fact that tbe ban applied to prod uct* already in the hands of consum ers and suppliers and required that such product* be repurchased by the manufacturer. The Commission's action insofar a* It prohibited the future sale of self-pressurised house hold products containing vinyl chlo ride monomer was not objected to. In a decision published In tbe tomas , Racism on October tl. 1074 (29 FR 98575). the Commission found that none of the objections received war ranted a stay of the effective date of the order or the holding of a public hearing. Tbe Commission noted that none of the objections contained a ref erence to or an offer to present factual Information which might lead the Commission to a conclusion contrary to that reached by it. As a result of tbe CommtosJaal rul ings os tbe objections, a petition for review of the vinyl chloride ban as it pertained to goods introduced into in terstate commerce prior to the effec tive date of the ban was fDed to the United States Court of Appeal* for tbe Ninth Circuit os October 2, 1074. (Pactra Industries, Inc. v. Consumer Product Safety Commission, Now 742002; 74-2168). That court, tn an opin ion filed on May 2.1077, aet aside the vinyl chloride ban on the basis that a public bearing on the objections should have been held.* *Thai Court of Appeals oo December 13. 1074 bad granted a stay of that porttoo of tbe Way) chloride ban which required rtpur- 1978, Commerce Clearing Ho o k , Inc. -J'Trrr- GL034896 Hazardous Substances 20.049-3 UJ, . fccr.TJhvfrd) ch\i* dispost) of all household product* In the chanseb of commerce tonUinlne Fttiy] chiorld- monomer feecaust the Court found that the Commission hu failed to corner ertth the rtouireiaeatt of the Na tion*] E&rirontM&U! Policy Act (REPAh 42 VE C- 4SJ1 et sec 8ubstguenUy. the. Cosmlstloc conducted as extensive esrirohsenUJ revie* cd the ban and concluded that the repurchase reoafraueat would bet have s Ag&ifica&t advene effect oo the human en vironment sad that n environments] impact ststexncst was swt neoeetary. The Court vacated the stay and the baa re mained to effect antQ May 2, 1971. In an effort to determine the appro priate regulatory response to the Facfrc decision, the Commission staff undertook a field survey to determine the extent of vinyl chloride-containing aerosols to the marketplace. That survey revealed that no new such products containing vinyl chloride had teen manufactured since 1674 and that, with the exception of three rela tively small lots betas held, virtually no products eostatataf vinyl chloride remained to the marketplace. The Commission contacted the i firms boldine the products and asked that they voluntarily destroy their existing inventories. The Urns subsequently reported that the Inventories bad either been destroyed or removed from Commission jurisdtetton. Because the tafonution available to the Commission indicates that vinyl chloride-containing aerosols are no longer being manufactured or held and because the Commission continues to believe that such products, if pro duced, would present a risk of serious JUness or injury, the Commission has decided to reisue tU tanning regula tion on a prospective basis only, as of the date of the arighgal ban (October 7, 1674). Such action wfD insure that oo aeif-proasuriaed faooaehold sub stances containing vinyl chloride mon omer are manufactured In the future. Qxooxsc roa rsx Bta Vinyl chloride is a odoriess. flamma ble gas under normal eoodJtJcn* of temperature and pressure, but b gen erally handled as a tiouid under pres sure. Among the synonyms and trade names for vinyl chloride are chloroethylene, monoebtoroetbeae, ethyl ene monochloride, rtoyl chloride mon omer, VC end VCM. Consumer Product Safety Guide Vinyl chloride monomer fe not known to occur in nature. The sub. stance has been produced commercial ly to the United States since at least 1628. In 1671, at least 67 percent of the vinyl chloride monomer consumed In the UJS. was for the production of vinyl chloride homopolymer and eopo- lytaer resins. The remainder was used to a variety of ways, such as the pro duction of methyl chloroform, as an additive to specialty coatings, and as a component of propellant mixtures for oertato aerosol products. Vinyl chloride has been shown to be carcinogenic by Inhalation to *rdrpi bioassays. In addition, a casual rela tionship has been demonstrated be tween exposure through inhalation of workers to vinyl chloride monomer during the polymerisation process and the onset of angiosarcoma of the liver, a very rare form of live cancer. The ntw] md human demonstrat ing the carcinogenicity of vtoyFcblo- ride was reference to the Commission's 1674 proposed and final vinyl chloride banning regulations (26 FR 18115; 29 FR 20113) and it summarised and up dated below. 1. AKnUlMXA In 1674 Professor Centre Kaltoni of the Institute di Oacologia, Bologna. Italy, reported on a aeries of experi ments on the effect of exposure through inhalation on rats. mice, and hamster* to vinyl Chloride monomer at concentrations of 10,006, 6,000 2,500. 500. 250, and 50 ppm for varying peri ods of time. Preliminary results of this study included the observation of an giosarcoma* of the liver to both rats and mice exposed to vinyl chloride at concentrations a* low as 250 parts per million is addition malignant tumors were Induced at aeveral other site* to both species. CMaltooi. C and O. la famine, "Carctaotenidty bioassay* on vinyl chloride. 1 Research plan and early results.** Zhvironm. Bet* 7:521 <1674)). Preliminary studies have suggested that vinyl chloride monomer cause* subcutaneous (occurring beneath the skin) angiosarcomas to the offspring of rats exposed to vinyl chloride during pregnancy. (1ARC Monographs on the evaluation of Carcinogenic Risk of Chemicals to Man, 7:291 <1674).) In addition, vinyl chloride monomer animal studies are currently being per- 16 CER 1500,17 126,11? Gl0397 20,049-4 Sti*3ards--labels--Bans ' 3.-9 *-7S (continued) formed it Edgewood Arsenal for CPSC (1975-1978) under an Intervene}' imtmrnt, The results of those stud ies we expected in the second quarter of 1978. S. ITTMAX PATA In early 1974, the B.F. Goodrich CbemJea) Company reported to the National institute for Occupational Gaiety and Health (NIOSH) that since 1971, three of Its employees, who had an average exposure of approximately 19 years to vinyl choride monomer at unknown concentrations, had died from angiosarcoma of the liver. At about the tame time reports of 10 other similar deaths among men em ployed at various vinyl chloride monomerpolymerisations plans ap peared in the literature. In tvo of the reported cases, angiosarcomas were present In tissues other than the liver. (Heath. C.W., Jr., Falk. H. and JX Creech, Jr. "Characteristics of eases of angiosarcoma of the liver aso&g vinyl chloride workers in the Halted States", Atm N.Y. Acad. 6d. (1974)1. At the time of its 1974 ban, previous ly cited herein, the Commission was aware of 24 confirmed eases of angio sarcoma among the 10,000 to 20.000 persons exposed to vinyl chloride In the course of their employment. As of August 1977. NIOSS reported a total of <3 cases of liver angiosarcoma among workers directly involved la the polymerization of VCM. Twenty-five of the eases developed among workers In the T7j S.. with the other 39 cases ob served In workers from 11 other coun tries. (Table 1. Reported Cases of An giosarcoma of the Liver Among Vinyl Chloride Polymerization Workers, sub mitted by X70SB (August. 1977)1. As angiosarcoma of the'ifver is extremely rare in the general population, there is agreement among scientists that this observation of 63 eases in vinyl chlo ride monomer worker* is evidence of a casual relationship. a. ACTJOKS ST OTfim AGEMCZXS In addition to the animal and human data demonstrating the car cinogenicity of vinyl chloride mon omer. the Commission notes that ac tions taken by other agencies further support this ban. For example, on Oc tober 4.1974, the Occupational Safety and Health Administration published a final standard (an emergency tempo 126,117 16 CTR 1500.17 rary standard and a proposed standard had been published earlier) setting an occupational exposure limit for vinyl chloride of 1 ppm averaged over any 6 hour period and a eeDing of 5 ppm av eraged over any period not exceeding IS minutes (36 FR 3S890). On August 36,1974 the Pood and Drug Adminis tration (FDA) published final rules ap plicable to the use of vinyl chloride monomer as an ingredient of self-pres surized drug and cosmetic products. The use of vinyl chloride in self-pres surised cosmetic products was banned, and an approved new drug application as a condition to marketing was re quired for aD aelf-presurized drug products containing the substance (39 PR 30890). On April 36,1974. the Envi ronmental Protection Agency pub lished an emergency suspension order and a notice to cancel the registration of all pesticide spray products contain ing vinyl ehloride that are used in the home, in food hT>diig establish ments, in hospitals, or in enclosed areas (99 PR 14763). This notice stated that under tome conditions of use of aerosol products in households, the concentration of propellant in the air could be as high as 400 parts per mil lion immediately after spraying. The registration of a number of pesticides was subsequently cancelled under this order (aee 40 PR 3494). Errocrm Dat s ax t > Arrucisiurr The regulation set forth below applies to all self-pressurized household products containing vinyl chloride monomer as ss Ingredient or In the propellant manufactured or Im ported cm or after October 7.1974, the effective date of the Commission's original banning order. The regulation will, therefore, permit -existing stock manufactured or Imported before that date to be sold. Since the Information available to the Commission indicates that such products are n longer being manufactured or held, the Commis sion believes that the primary effect of this regulation will be to Insure that fnyl chloride monomer will not be used as an Ingredient or at a propel lant in household products In the future. -- The regulation la effective June 22, . 1978, exoept as to any provision that may be stayed by the filing of proper _ objections. Any written objections.', must be filed by April 34. 1978. The Cotnmisstoo wtD consider all objec tions prior to the effective date of this G1978, Commerce Clearing House, Inc. > .j.: GL034898 ' '--r^5r5 ; ^^(continued) which may be required under tbe FBSA, the degree or nature of tbe ten: and as an alternative to (laying tbe ten as a result of the objections and holding a bearing, the Commis sion may revise its final order. hazard Involved in the presence or use of the substance to households is such that the public health and safety can be adequately served only by keeping that substance out of the ehEwnrtu of Eh v z x o k z c z f t ai- Co x s id ee a t io h s Pursuant to section 1021.5 of the Commissio p's proposed and interim procedui es implementing tbe National Environmental Policy Act CNEPA) (Id CFR 1022). tbe Executive Director of the Commission has determined that this ban is not a major action, that its impact on tbe environment will be negligible, and that no environmental review U necessary. Tbe Executive Di rector's determination, a copy of which is on file at tbe Office of the Secretary, concluded that tbe ban would have no environmental effect because no product which would be af fected by the ban Is currently being produced or held in Inventory. There fore, slnoe no vinyl chloride aerosols are currently in the channels of com merce. tbe environmental issue of dis posal of repurchased products which was present at the time of tbe initial ten is cow moot (At that time tbe Commission bad concluded that dis posal of concentrations of vinyl chlo ride aerosols could be accomplished without significant environmental danger. (40 FR 41120).) Coxaxtiox Section KfXlXA) Federal Hazardous Substances Act defines "hazardous substance" as "any substance or mix ture of substances which is toxic... if such substance or mixture of sub stances may cause substantia) personal Injury or substantial nines* during or as a proximate result of any custom ary or reasonably foreseeable handling or use, ineluding reasonably foresee able ingestion by children." 8ectIon Kg) of the set states that the term "toxic" includes any substanoe or mix ture of substances which has the ca pacity to produce personal injury or to man through ingestion, inha lation, or absorption through any body surface. Provisions of section KqXlXB) authorise tbe Commission to issue regulations to classify a "haz ardous substance" which Is packaged or suitable for use in households as a "banned hazardous substance" if the Commission determines that notwith standing any cautionary labeling interstate commerce. After careful consideration of all available information as discussed above, the Commission lias decided to affirm its earlier determination (see 39 FR 30)12) that self-pressurized house hold products containing vinyl chlo ride monomer are toxic hazardous sub stances within tbe meaning of sections 3 (f) and <g) of tbe FESA because vinyl chloride monomer, when In haled, has tbe capacity to produce substantial Illness, specifically cancer. The Commission believes that ample evidence in the form of scientific stud ies and chemical reports is available to establish tbe carcinogenicity of vinyl chloride monomer by inhalation and to demonstrate that human exposure to the substanoe can -result In angio sarcoma of the'liver. As Indicated above, it has been reported that vinyl chloride monomer may be present in the air is concentrations as great as 400 parts per mZQion after household use of self-pressurised containers with vinyl chloride Id the propellant. Tumors have been induced tat mice after exposure to VCX in concentra tions as low at 350 part* per million. Because so safe level of human ex posure to vinyl chloride monomer has been established, tbe CommWm fur ther has decided to affirm its earlier Coding that adequate cautionary la beling cannot be written under the FB&A for self-pressurised hdosehold products containing vinyl 'Chloride monomer. Tbe Cbmmissfoo concludes that tbe degree and nature of the hazard presented by tbe tm of self- pressurized household products con taining VOf is such that the public health and safely can he adequately served only by keeping such products . out of the pf interstate com merce. Therefore, oo the effective date of the regulation promulgated below, all self-pressurised household products eoctainiu* VC3I manufac tured or Imported on or after October 7, 1374 become banned hazardous sub stances. Accordingly, pursuant to provisions of the Federal Hazardous Substances Act (secs. KfXl), UX CBX <f>. (qKlXBX **). 74 SUt 372. 374. as amended SOBtaL 130-06,tt8taL 1S7- Consumer Product Safety Gmdc 16 CFR 1500.17~126,117 GLD34899 / 20,050 Standards--Labels--Bans 139 b-78 f^^(corjtinued) 199. 90 But. 503; H O.S.C. mi. 19921 and the Federal Food. Druf tad Cos metic Act tec. 701 (e). (f), (), 53 St*t. 1055-56, *s amended 70 St*t 910, 73 8t*t. M8: 31 v j b .c . rn <>. c/>. <. and under authority reeled tn the Consumer Produet Safety Commission by the Consumer Product Safety Act <MC. UKa). 56 Slat. 1331; 16 US.C. 3079(a)). 16 CFR 1500.17 J* amended by deleting the existing paragraph (aXIC) and by adding a new paragraph <aX10), as follows (unchanged, the In troductory text of paragraph (a) is In cluded below for context): * **** Any person who win be adversely af* feeted by the foregoing order may at any time on or before AprB M, 1978, file vtth the Office of the Secretary. Consumer Product Safety Commisstoa ill] 19th 8treet NW., Washingtern. D.C. 30307. written objections thereto, preferably la flee copies. Ob jections shall show wherein the person fgtnt wOl be adversely affected by the order and specify with particularity the provisions of the order deemed ob jectionable and the grounds for the objections. Objections should raise material imues that are not frivolous 126,117 16 CFR 1500.17 or inconsequential. If a bearing is re quested, the objections must state the Issues for the hearing. Objections may be accompanied by a memorandum or brief Id support thereof- Received ob jections may be seen fa> the above office during working hours Monday through Friday. Effective date: 71m regulation pro mulgated above shall become effective June 22,1978, except as to any provi sion that may be stayed by the Cling of proper objection*. As Indicated above, as as alternative to staying the ban as a result of any objections and bolding a bearing, the Oocomlasioo may revise Its final aider. JVotioe of the fifing of Objections or the-lack thereof or any ammang of the jtoaI older wfD be given by pubhcatioc in the Psooui. Rasxtm. CBea. XfXU U>, (B), <S\ (CXIXB). 9(a). 74 tat. 973, 9H as attended 90 But 7904-06. S3 BUI. 197-196. 90 Mat M 09 DAC titl imr. a*c. 791 (aX eft teX 99 But lfiO-U. as amecKM TV But 919. 73UL Ml (tl VAC 971 OX (ft (S>X me. 9Ma). 96 dut 1991 US VAC WJWalU . --- pated- March 17. 1971. 8un 8 Dmnr. Acting Secrete** Omsioner Product Scjtt* Commission. 1779, Cotsmert* Gearing Booae, Inc. GL D34900