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22936 [4910-13] (Airspace Docket Ho. ia.WE-5) PART 71--DESIGNATION OP FEDERAL AIRWAYS, AREA LOW ROUTES, CONTROLLED AIRSPACE, AND RE. PORTING POINTS ..... PART 73--SPECIAL USE AIRSPACE Designation of Temporary Restricted Aroo'^V', AGENCY: Federal Aviation Adminis tration (FAA), DOT. jh:-rx > ACTION: Pinal rule.{ ' r SUMMARY; These amendments des ignate a temporary, restricted area identified a* R-2309 in the vicinity oi Bill Williams River Valley, Arts., to contain high explosive detonations. These amendments .provide lor the ult and efficient use of the navigable airspace by prohibiting unauthorized flight operations of nonparticipatlng aircraft within the rfeilgnitsd areas during the designated period. EFFECTIVE DATE: July 13, 1978. Period of designation is August 27, 1978. through September 2,1978. FOR FURTHER . INFORMATION CONTACT! Mr. Richard Huff. Airspace Regula tions Branch (AAT-230), Airspace and Air Traffic Rules Division, Air Traffic Service. Federal Aviation Ad* ministration. 800 Independence Avenue SW,, Washington. D.C. 20591; telephone: 202-426-3715. SUPPLEMENTARYENPORMATION: HlSTOST- On April 20,1978, the FAA proposed to *wni! Parts 71 and 73 of the Feder al Aviation Regulations (14 CFR Parts 71 and 73) to designate a temporary restricted area identified as R-2309 in the vicinity of Bill Williams River Valley, Aria., to oontain high explosive detonations and to include this re stricted area in the continental control area for the duration of its time of designation (43 SR 18741). Interested persons were invited to participate In ihe rule making proceeding by submit ting written comments on the proposal to the FAA. We received two responses to the JTPRM In which the com mented posed no objections to the proposal. Sections 71.151 and 73.23 were republished in the Federal Reg ister on January 3, 1978. (43 PR 344 and 084). TezRulx These amendments to Parts 71 arid 73 of the Federal Aviation Regulations designate a temporary restricted area in the vicinity of Bill Williams River Valley, Ari2., to protect nonpartlcipat- RECfclVED ' |(<?5 RULES AND REGULATIONS ine aircraft from a large scale airblastM AYlsshid^ Washington. D.C.. on May associated with a high explosive field 23,1978. test program called Miser* Bluff, -r BAR&auC.Broadwaw*. which involves the detonation of high** 1 Chief, Airspace and Air explosives. In addition, the alnpace at TrafficRules DirAsiort. and above 14,500 feet MSL during the designated period (continuously from Doe. 7S-14SS6 rued 8-26-78: 8:4$ am] 0001 August 27. 1978. through 2400 hours, local time September 2. 1978) Is included in the continental oontrol are^-'Theee amendments adopt the 5-01] Title 18- Commercial Prentices airspace actions proposed In the NPRM <43 PR 16741). In accordance with established FAA policies, the CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION agency has provided the FAA with a statement that the require ments of the National-Environmental susatam* c--dai hazardous SUBSTANCSS ACT MOULATIOftS Policy Act have been met. PART 1500--HAZARDOUS SUB ' Daarrma imoattATZoy STANCES AND ARTICLES; ADMIN The principal authors of this docu ment are Mr. Richard Huff. Air Traf fic Service, and Mr. Richard W. Dan- ISTRATION AND ENFORCEMENT REGULATIONS forth. Office of the Chief Counsel. Seif-Pressurised Hooiehold Sub* Adoptzox or TEX AacoroitETT stances Containing Vinyl Chloride Accordingly, punuant to the author ity delegated to me by the Administra Monomer; Classification as Eannad Hazardous Substance tor, Subpart D of Part 71 and Subpart B of Fart 73 of the Federal Aviation Regulations (14 CFR Farts 71 and 73) as republished (43 FR 344 and 884) are AGENCY: Consumer Product Safety Commission. ACTION: Confirmation of final order. amended, effective 0901 Out, July SUMMARY: The Commission an 13,1978, as follows: nounces that so objections have been In f 71.151, the following temporary filed within the statutory period to its restricted area is added for the dura tion of its time of designation from 001 hours, August 27, 1978, through 2400 hours, local time, September 2, 1978: final order of March 24. 1973 classify ing any household substance in a selfpressurized container containing vinyl chloride monomer, manufactured or Imported on or after October 1. 1974, as a "banned hazardous substance.'* In B-nwuinuBim.Aia. this document the Commission, there Za <73.33, the following temporary re fore. confirms the final order. stricted area Is added: DATES: The effective date of the rule R-2309 Uznu Blvtt. An. Boundoris*. A circular area with a 10-nautlcal mile radius centered at lit. S4TS.5' N, long. 113**2.? W. DesUmMed ettUudss. Within a l.OOO-foot radius centered at tot. 34*15.5' N-, long. declaring any household substance is a self-pressurized container containing vinyl chloride monomer to be a banned hazardous substance Is June 32, 1978. The rule to applicable to products which have been manufac 112*525' W., surface to FL 320: within tbs tured or imported on or after October circular area that ilea between the 3,000- 7,1974. foot radius and the lo-nautlcal mile radius centered at tot 34*155'- N,, long. 113*835' FOR FURTHER INFORMATION W.. 100 feet above the surface to FL 120. CONTACT: Time af designation. Continuous, 0001. Ausust 27 through 2400 hours, local time, September 2,1971. Controlling opmeg, Federal Aviation Ad Charles Jacobson. Consumer Prod uct Safety Commission, Directorate for Compliance and Enforcement, ministration, Albuquerque ARTCC. Division of Regulatory Management. Using openeg. Defense Nuclear Agency Washington, D.C. 20207, 301-492- Field Command. Klrttoad Air Fore* Sue, N. Hex. (Seta. 307(a). 313(a). Federal Aviation Act of 1958 (49 UJS.C. 1345(a) and 1354(a)); Me. 6(e), Department o( Transportation Act (49 D5.C 1855(c)); and 14 CFR 11.69.) Nor*.--The FAA has determined that this document does not contain a major proposal requiring preparation of an Economic 8400. SUPPLEMENTARY INFORMATION: On March 34, 1978 the Commission published in the Fdbial Register, 43 FR 12305, a final regulation* pursuant to section 2(q)Cl)(3) of the Federal Hazardous Substances Act (FHSA), 15 U.3.C. 1281(qXl)(B), declaring any Impact Statement under Executive Order 11821, as amended by Executive Order 1Editorial note: The final regulation re 11949, and OMB Circular A-10T. vised 16 CFR ISOO.lKaXlO). ! * I I i > i i FEDHAl MOOTS*, VOL 43, NO. 104--'TUESDAY, MAY 30, 197S .1 ..-a** * . -- 1 AP000I1074 f RULES AND REGULATIONS 22937 self-pressurized products intended or suitable for household use. manufac tured or imported on or alter October 7, 1974, that contain vinyl chloride monomer (VCM) as an ingredient or In the propellant to be "banned hazard* ous substances.'! The final regulation was a reissuance of an earlier fully ret roactive ban (39 PR 30112) that had been set aside for failure to hold a hearing on objections to the retroac tive effect of the regulation. (For a complete background discussion on the original ban, see the preamble to the March 24,1&7B notice.) In the March 24, 1978 document the Commission affirmed its deterrains* tion made In the original ban that self* pressurized household products con taining vinyl chloride monomer are toxic hazardous substances within the meaning or the FHSA because of vinyl chloride monomer, which, when in haled, has the capacity to produce substantial Illness, specifically cancer. Because no safe level of human expo sure to vinyl chloride monomer has been established, the Commission fur ther affirmed its earlier finding that adequate cautionary labeling could not be written under the FHSA for self-pressurized household products containing VCM and concluded that the degree and nature of the hazard presented by the use of these products Is such that the public health and safety can be adequately served only by keeping the products out of Inter state commerce. Zn taking the banning action, the Commission noted that ample scientific evidence in the form of long-term animal bioassays and human epidemiological studies Is avail able to demonstrate the carcinogen icity of vinyl chloride monomer by in halation and to demonstrate that human exposure to the substance can result in angiosarcoma of the liver, a rare form of liver cancer. The March 24, 1976 banning regula tion also provided, as is required for the Issuance of regulations pursuant to section 2;q)(l)<B) of the FHSA, that the procedures for rulemaking under section 10Ke> of the Federal Food, Drug and Cosmetic Act would govern and that adversely affected persons could fUe .objections and re quests for a public hearing within 30 days of the publication of the.Cominisslon's final order. The last day for the filing of objec tions with the Commission was April 24,1978. Since no objections have been filed within the statutory period, the Commission in this document con firms Its final order of March 24,1978, declaring as banned hazardous sub stances any self-pressurized household products containing vinyl chloride monomer as an Ingredient or is the propellant, manufactured or imported on or after October 7,1974. `Sets*. 2(0(1), (A), (B), <g), (qXlKB), 3<a>. 74 Stit. 372. 374. as amended 80 SUt I3W-0S, 83 Scat. 187-119. 90 SUt. 803 (19 ttS.C. 1281, 1202); sec. T01 (e). (f). <t). 52 Stat. 1059-58, as amended 70 Stat. 919. 72 Stat. 048 (21 UJ3.C. 371 Ce>, (1), (S; hc. 30(a), 30 Stat 1231 (15 UJ3.C. 2079(a)).) Dated: May 23,1978. Sadt* f. Draw, Acting Secretary, Consumer ProductSafety Commission. [PR Doc. 78-14883 Plied 8-36-78; 8:48 am) [4810-22] Title 19--Custom* Duties CHAPTER 1--UNITED STATES CUS TOMS SERVICE, DEPARTMENT OP THE TREASURY ITh 78-150) . PART 153--ANTIDUMPING Carbon Steel Plato From Japan AGENCY: UjS. Treasury Department ACTION: Finding of dumping; final rule. . SUMMARY: This notice is to inform the public that separate Investigations conducted under the Antidumping Act 1921, as amended, by the U.S. Treasury Department and the Inter national Trade Commission, respec tively, have resulted in determinations that carbon steel plate from Japan is being sold at less than fair value and that those sales are Injuring an Indus try in the United States. On this basis, a finding of dumping is being issued and, generally, all unappralsed entries of this merchandise will be liable for the possible assessment of special dumping duties. EFFECTIVE DATE: May 30,1978. FOR FURTHER INFORMATION CONTACT: Stephen Nyschot. U.S. Customs Service. Office of Operations. Duty Assessment Division, Technical Branch, 1301 Constitution Avenue KW., Washington, D.C. 30229 202S 05-5492. SUPPLEMENTARY INFORMATION: Section 201(a) of the Antidumping Act, 1921, as amended <19 U.S.C. 160(a)), gives the Secretary of the Treasury responsibility for determin ing whether imported merchandise is being sold at less than fair value. Pur suant to this luthorlty the Secretary of the Treasury has determined that carbon steel plate from Japan Is being sold at less than fair value within the meaning of section 201(a) of the Anti dumping Act, 1921. as amended (19 U.S.C. 160(a)). (Published In the Fed eral Register of January 13, 1978 (43 FR 2032).) An "Amended Determina tion of Sales at Less Than Fair Value" was published in the Feduul Register of March 27,1978 <43 FR 12780). Section 201(a) of the Antidumping Act, 1921, as amended <19 U.S.C. 160(a)), gives the United States Inter national Trade Commission responsi bility for determining whether by reason of such sales at lea thnn fair value a domestic Industry is being or is likely to be injured. The United States International Trade Commission has determined, and on April 18. 1978, it notified the Secretary of the Treasury that a domestic Industry Is being in jured by reason of leu than fair value imports of carbon steel plate from Japan. (Published in the Fedsax. Rro ister of April 24, 1978 (43 FR 17410)). On behalf of the Secretary of the Treasury. I hereby make public these determinations, which constitute a finding of dumping with respect to carbon steel plate from Japan. For purposes of this notice, the term "carbon steel plate" means hot-rolled carbon steel plate, 0.1S7S <**> inches or more in thickness, over 8 inches la width, not in coils, not pickled, net coated or plated with metal, not dad, and not cut, pressed, or stamped to non-rectangular shape. Section 153.46 of the Customs Regu lations <19 CFR 163.48) la amended by adding the following to the list of find ings of dumping currently In effect: }153.45 Llit of current finding*. eaa Merchandise, countrr and T.D. Carbon steel piste, Japan, 78-150. (Secs. 201, 407. 42 SUt. 11, as amended, 18 (19 TJ.S.C. ISO. 173).) Robert H. Mvwdhzxm, General Counsel. Mat 23,1978. IFR Doc. 78-15014 Filed 8-28-78; 8:45 am) [4110-03] Title 21--Food and Drags CHAPTER l--FOOD AND DRUG AD MINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WEL FARE SUICHAFTER 8--FOOD FOR HUMAN CONSUMPTION (Docket No. TTN-01T7J SODIUM THIOSULFATE; AFFIRMA TION OF GRAS STATUS AS A DIRECT AND AN INDIRECT HUMAN FOOD INGREDIENT AGENCY: Food and Drug Administra tion. ACTION: Final rule. SUMMARY: This rule affirms that sodium thiosulfate is generally recog- FEDERAL REGISTER, VOL 48, NO. 104--TUESDAY, MAY 30, 1971 I Xp6o6u675 12308 RULES AND REGULATIONS KLCUVED This amendment postpones the ef fective date of the subject regulation from March 23.1978. to May 22, 1978. and must be made effective Immedi ately to accomplish its purpose in the public interest. It does not appear that public participation In this nUemakin** proceeding would make additional rel evant information available to the De partment. Accordingly, under the administra tive procedure provisions of 5 U.S.C. 553, it is found upon good cause that further notice and other public proce dure with respect to the amendment are impracticable, unnecessary, and contrary to the public interest. Done at Washington. D.C* this 22th day of March 1978. Mom--The Animal and Plant Health In spection Service has determined that tw document does not wwtin g major proposal requiring preparation . of as Inflation Impact Statement under Executive Order 11131 and OMB CircularA-107. S. A. Schtip, Acting DeputyAdminUtrater. VeterinaryServlets. * tTR Doc. 7S-SC10 Plied 1-23-73: *53 ami [*355-01} TUI* 1 .HAZAIDOUS (ttl ACT RMUIATION* PART 1500--HAZAIDOUS SUB STANCES AND ARTICLES; ADMIN ISTRATION AND ENFORCEMENT REGULATIONS Self-Pressurized Household Su^ stances Containing Vinyl Chloride Monomer; Classification be Sunned Hazardous Substanco- ' AGENCY: Consumer Product Safety Commission. ACTION: RdUsuanba of final regula tion. ; SUMMARY: The Commission reissues a regulation dasilfylhg any household substance In a self-pieeiurteed contain er containing vinyl chloride monomer -es a "banned hazardous substance" under the Federal Hazardous Sub stances Act. The Commission believes that there is 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 cancer. The Commission is reissuing this regu lation on a prospective basis, as of the date of the original ban (October 7, -1974), because that original retroactive ban was set 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 is no longer necessary. DATES: The effective date of the rule Is June 22,1978. The rule is applicable to products which are manufactured or imported on or after October 7, 1974. Any written objections must be received by April 24,1978. 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, 301-492-8400. SUPPLEMENTARY INFORMATION: Backcxouttd On August 21, 1974 the Commission published In the Federal Register, 39 FR 30112, a final regulation pursuant to section 2(q)(lXB) of the Federal Hazardous Substances Act (FHSA), 15 UAC. 1201 (qXlXB), declaring any self-pressurized products Intended or suitable for household use that con tain vinyl chloride monomer aa an in gredient or In the propellant to be "banned hazardous substances" (the proposed regulation was published in the Federal Rsazsrza on May 23, 1974 (39 PR 18115)). The Commission took that action because of scientific stud ies Uniting the death of industrial workers from a rare form of liver cancer to vinyl chloride exposure and because of certain animal studies fur ther indicating the carcinogenicity of vinyl chloride monomer. In that same document the Commission declined to exeroise any discretion, which it might have had under the FHSA, to make its order prospective only, thus requiring repurchase of products al ready distributed under the provisions of section 15 of the FHSA (15 U.S.C. 1274). That document also provided, as is required for the issuance of regula tions pursuant to section 2(qXlXB) of the FHSA, that the procedures for ru lemaking under section 701(e) of the Federal Food. Drug and Cosmetic Act would govern and that adversely af fected persons could file objections and requests for a public hearing within 30 days of the publication of the Commission's order. Four statements containing objec tions and requests for a public hearing were received by the Commission. The objections filed focused primarily on the fact that the ban applied to prod ucts already in the hands of consum ers and suppliers and required that such products be repurchased by the manufacturer. The Commission's action Insofar as It prohibited the future sald^&^^f-iJrJsl^lzed house hold products containing vinyl chlo ride monoomr-wasiDQfctbksted to. In a decisfcn thro/SwlS the Fxoss- - al Ricisto on October 11, 1974 (39 FR 38578), 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. The 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 the Commission's nil-' legs on the objections, a petition for review of the vinyl chloride baa as it pertained to goods introduced into In terstate commerce prior to the effec tive date of the ban was filed in the United States Court of Appeals for the. Ninth Circuit on October 2, 1974. (Pactra Industries,1 Inc, v. Consumer Product Safety Commission. Nos. 74-' 2902; 74-3168). That court. In an opin ion filed on May 2, 1977, set aside the vinyl chloride ban on the basis that a public hearing on the objections should have been held.* In an effort to determine the appro-' priate regulatory response to the Pactra decision, the Commission staff undertook a field survey to determine the extent of vinyl chloride-containing aerosols in the marketplace. That survey revealed that no new such* products containing vinyl chloride had been manufactured since 1974 and that, with the exception of three rela tively small lots being held, virtually no products containing vinyl chloride remained in the marketplace. The Commission contacted the 3 firms holding the products and asked that they voluntarily destroy their existing inventories. The firms subsequently reported that the inventories hM either been destroyed or removed from Commission jurisdiction. Because the Information 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 ' "That Court of Appeals on December IS, 1914 had granted a stay of tbit portion of the vinyl chloride ban which required repur chase and disposal of SU household products in the Channels of commerce containing vinyl chloride monomer because the Court found that the Commission has failed to comply with the requirements of the Na tional Environmental Policy Act (NEPA), 43 UJ3.C. 4331 et seq. Subsequently, toe Com mission conducted an extensive environmen tal review of the ban and concluded tost the repurchase requirement would not have a significant advene effect on the human en vironment and that an environmental Impact statement was not necessary. The Court vacated toe stay and toe baa re mained In effect until May 2,1977. R0EXAL MOtlTO, VOL 44, NO. 38--ffttPAY, MAICH 34, 1971 w AP0001I076 t RULES AND REGULATIONS 12309 Illness or injury, the Commission has decided to Teton* Its regula tion on a prospective basis only, as of the date of the ericfngal ban (October 7, 19741. Such action will insure that no aelf-pressartasd household sub stance* ecntainlnx vinyl ehloride mon omer an manufactured in the future. atoms mm Bax Vinyl chloride is a colorless, flamma ble gas under normal conditions of temperature and pressure, but is gen erally handled as a liquid under pres* sure. Among the synonyms and trade names for vinyl chloride are chloroetbylene. monochloroethcne, ethyl* ne moeochksride^ vinyl chloride mon omer. VC and VOC. vinyl chloride monomer la not known to occur In nature. The sub stance has been produced commercial ly in the Uhited State* since at least 1923. In 1971* at least 97 percent of the vinyl chloride monomer consumed in the U.S. waa for the production of vinyl chloride homopolymer and copo lymer resins. The remainder was used in 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 certain aerosol products. Vinyl chloride has been shown to be carcinogenic by inhalation in animal bloassays. m addition, a casual rela tionship has tea demonstrated be tween expoCTiv through inhalation of workers to vinyl chloride monomer during the polymerization process and the onset of angiosarcoma of the liver, a very rare form of live cancer. The animal and human data demonstrat ing the carcinogenicity of vinyl chlo ride was reference In the Commission's 1874 proposed and Hwi vinyl chloride banning regulations (39 EH 18116; 39 PR 30113) and is summarized and up dated below. 1. AXZXAI.'xUXA In 1974 Professor Cosare Maltonl of the Instttuto dl Otocologia, Bologna. Italy, reported on a series of expertmeat* cm the effect of exposure through fnfrsletirm on xmfs. mice, and hamsters to vfnyf chloride monomer at concentrations o 10.000, 0,000 3,500, 590, 250, and Mppmfor varying peri ods of time. Preliminary results of this study included the observation of angiosaroomas-ef the-liver In both rats and mice exposed to vinyl chloride at conccntraHnm as low as 250 parts per ouUSoi), hx addition, milig&axit tumor? vere Induced at several other sites in both species. (Ualtoni. C and O. La lemlne, "Carcinogenicity bioassays on rinyi chloride. L Research plan and early results." Environm. Res., 7:387 (1974)). Preliminary studies have suggested that vinyl chloride monomer causes subcutaneous (occurring beneath the skin) angiosarcomas in the offspring of rats exposed to vinyl chloride during pregnancy. (IARC Monographs on the Evaluation of Carcinogenic Risk of Chemicals to Man, 7:291 (1974).) In addition, vinyl chloride monomer nim] studies are currently being per formed at Edgewood Arsenal for CFSC <1979-1978) under an Interagency agreement. The results of those stud ies are expected in the second quarter of 1978. a. BCHAiTssxa In early 1974, the B.F. Goodrich Chemical Company reported to the National Institute for Occupational Safety and Health (NlOSH) that since 1971, three of Its employees, who had an average exposure of approximately 19 years to vinyl cborlde monomer at unknown concentrations, had died from angiosarcoma of the liver. - At about the same time reports of 10 oth deaths mwahj wn em ployed at various vinyl chloride monomerpolymerlzatlons plans ap peared in the literature- In two of the reported cases, angiosarcomas were present in tissues other than the liver. (Heath, C.W.. Jr.. Falk. H. and JJL. Creech. Jr. "Characteristics of cases of angiosarcoma of the liver among vinyl chloride workers In the United States''. Ann N.Y. Acad. Sci. (1974)). At the time of its 1974 ban, previous ly cited herein, the Commission was aware of 24 confirmed cases 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. NlOSH reported a total of 63 cases of liver angiosarcoma among workers directly involved In the polymerization of VCM. Twenty-five of the cases developed among workers In the UJS., with the other 38 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 NlOSH (August, 1977)). As angiosarcoma of the liver Is extremely rare In the general population, there is agreement among scientists that this observation of 63 cases in vinyl chlo ride monomer workers la evidence of a casual relationship. S. ACTXOXS BT OTHER AGEXCHS 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 rary standard and a proposed standard had been published earlier) setting an occupational exposure limit for vinyl chloride of l ppm averaged over any 8 hour period and a celling of 5 ppm av. eraged over any period not exceeding 16 minutes (39 FR 35890). On August 26, 1974 the Pood and Drug Adminis tration (PDA) 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 surized cosmetic products wu banned, and an approved new drug application as a condition to marketing was re quired for all self-presurized drug produets containing the substance (39 fr 30830). On April 25.1974, 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 chloride that are used In the home. In food handling establish ments, in hospitals, or in enclosed areas (39 FR 14753), This notice stated that under some 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 (see 40 FR 3494b , i Ejtxcttvx Dats Am Attlicabilitt The banning regulation set forth below applies to all self-pressurized household products, containing vinyl chloride monomer as an ingredient or in the propellant manufactured or im ported on 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 indicate* that such products are no longer being manufactured or held, the Commis sion believes that the primary effect ' of this regulation will be to insure that vinyl chloride monomer will not be used as an ingredient or as a propel lant In household products In the future. The .regulation is effective June 22. 1978, except as to any provision that may be stayed by the filing of proper objections. Any written objections must be filed by April 24, 1978. The Commission will consider all objec tions prior to the effective date of this ban: and as an alternative to staying the ban as a result of the objections and holding a hearing, the Commis sion may revise its final order. EkVXROXHXMTAI COXSZBOUTIOHS Pursuant to section 1021.5 of the Commission's proposed and Interim procedures implementing the National Environmental Policy Act (NEPA) <16 CFR 1021), the Executive Director of the Commission has determined that this but is not a major action, that Its impact on the environment will be FIDIAAL MOUTH, VOL 43, NO. M--niDAY, MAJLCH 24, 197* AP00011077 12310 RULES AND REGULATIONS negligible, and that no environmental review la necessary. The Executive Di rector's determination, a cop; of which is on flit at the Office of the Secretary, concluded that the 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, since no vinyl chloride aerosols are currently In the channels of com merce, the environmental Issue of dis posal of repurchased products which was present at the time of the Initial ban is now moot. (At that time the Commission had concluded that dis posal of concentrations of vinyl chlo ride aerosols could be accomplished without significant environmental danger. (40 FR 41170D Ooatxnaioa Section XfXlXA) Federal Hazardous Substances Act defines 1'hazardous substance** aa "any substance or mix ture of substances which Is toxic... if sueh mihstanoe or mixture of sub stances may **tt substantial personal injury or substantial tTTnnss during or as a proximate wait of any eaitcmtry or reasonably foreseeable handling or use. tnemdtns leitonsbly foresee able ingestion by children." Section 2(g) of the act states that the tana "toxic** includes any substance or mix ture of substances which has the ca pacity to produce personal injury or illness to man throush ingestion, inha lation. or absorption through any body surface. Prwialana of section 2(a)(1)(B) authorize the Commission to issue regulations to classify a "haz ardous substance" which is packaged or suitable far use in households as a "banned hasardous substance" if the Commission determines that notwith standing any cautionary labeling which may be required under the FHSA. the degree or nature of the hazard involved in the presence or use of the substance in households is such that the public health and safety can be adequately served only by keeping that substance out of the channels of Interstate commerce. After careful. consideration of all available information as discussed above, the Commission has decided to affirm its earlier determination (see 39 PR 30112) that self-pressurized house hold products containing vinyl chlo ride monomer axe toxic hazardous sub stances within the meaning of sections 2 <f) and <g> of the FHSA because vinyl chloride monomer, when In haled, has the capacity to produce substantial *, specifically cancer. The Commission believes that ample evidence In the form of scientific stud ies and chemical reports Is available to establish the carcinogenicity of vinyl chloride monomer by Inhalation and to demonstrate that human exposure to the substance can result in angio sarcoma of the liver. As indicated Any person who will be adversely ef above, it has been reported that vinyl - fected by the foregoing order may at chloride monomer may be present In any time on or before April 24. 1978, tiae air in concentrations as great as file with the Office of the Secretary, 400 parts per million after household Consumer Product Safety Commit use of self-pressurlred containers with sion. 1111 18th Street NW,, Washing vinyl chloride In the propellant ton, D.C. 20207, written objections Tumors have been Induced in mice after exposure to VCM In concentra tions as low as 250 parts per million. Because no safe level of human ex posure to vinyl chloride monomer has been established, the Commission fur ther has decided to affirm its earlier that adequate cautionary la beling cannot be written under the FHSA for self-pressurized household products containing vinyl chloride monomer. The Commission concludes that the degree and nature of the hasard presented by the use of selfprassurixed household products con taining VCM is such that the public health and safety can be adequately served only by keeping such products out of the channels of interstate com merce. Therefore, on the effective date of the regulation promulgated thereto, preferably In five copies. Ob jections shill show wherein the person filing will 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 issues that are not frivolous or inconsequential. If a hearing is re quested. the objections must state the issues for the hearing. Objections may be accompanied by a memorandum or brief in support thereof. Received ob jections may be semi la the above office during working hours Monday throush Friday. Effective date: The regulation pro mulgated above shall become eifecttve June 22, 1978. except as to any provi sion that may be stayed by .the filing below, all self-pressurized household of proper objections. As Indicated products containing VCM manufac above, as an alternative to staying the tured or imported on or after October ban as a result of any objections and .7,1974 become banned hazardous sub stances. Accordingly, pursuant to provisions of the Federal Hazardous Substances Act (secs. 2(f)(1), (A), (B), (g), (QX1XB). 3(a). 74 Stat. 372, 374. as amended 80 Stat. 130-05, 83 Stat. 1ST189, 90 Stat. 503; 15 U.S.C. 1261. 1262) and the Federal Food. Drug and Cos metic Act (sec. 701 <e), (I), <g), 52 Stat. 1055-56, as amended 70 Stat. 919. 72 Stat. 948; 21 U-S.c. 371 (e), (f), <g. and under authority vested In the Consumer Product Safety Commission by the Consumer Product Safety Act (sea 30(a), 89 Stat. 1231: 15 U.S.C. 2070(a)), 16 CFK 1500.17 Is amended by deleting the existing paragraph (a)(10) and by adding a new paragraph <aX10), as follows (unchanged, the in troductory text of paragraph (a) is In cluded below for context): holding a hearing, the Commission may revise its final order. Notice of the filing of objections or the lack thereof or any amending of the final order will be given by publication in the Fzsxxax, Rsoxsm. (Secs. 2(f)(1). (A). CB), <f>, (qXlXB), 3(a), 74 Stat. 373, 374, aa amended S6 Stat. 1304-05, S3 Stat. 187-183. 30 Stat. 603 (15 US.C. 3101, 1303); mc. 701 <), (f). (*), aa Stat. 1055-50, ae amended 70 Stat, 913, 73 Stat. 345 (21 U.S.C. 371 Ce), (I), <g)X see. 30(5), 80 Stat. 1231 (15 URC. 2079(a.) Dated: March 17.1978. SadtxE. Dttww, ActingSecretary, Consumer ProductSafety Commission* C7R Doc. 78-7613 Filed 3-33-73; 8:43 ami [1505-01] |2566.17 Banned, hazardous substances. (a) Under the authority of section 2(qKlXB) of the act, the Commission declares as banned hazardous sub stances the following articles becauss they possess such a degree or nature of hasard that adequate cautionary la beling cannot be written and the public health and safety can be served only by keeping such articles out of in terstate commerce; Title 21--Feed end Dregs CHAPTER !--FOOD AND DRUG AD MINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WEL FARE SUtCHAPTlK I--AN1MAI MUSS, FttOS, ANO KELATIO PRODUCTS (Docket No. 77N-0163I PART 500--GENERAL (10) Self-pressurized products in tended or suitable for household use that contain vinyl chloride monomer as an ingredient or in the propellant manufactured or imported on or after October 7.1974. m Subpart B--Specific Administrative Rulings and Decisions Correction In FR Doc. 7A-6051 appearing on page 9802 In the issue of Friday. March 10, 1978, on page 9803, In the FEDERAL RIOBTSC, VOL 43. NO. St--FRIDAY. MAXCH 24, 1978 t AP00011078