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RULES. AND REGULATIONS 2-7 Ts be a valid assay, the percent column recovery should be 100i2 percent. <o> Identity. Proceed as directed in S 141.521 of this chapter, usmg a 0.5 percent potassium bromide disc prepared as described in paragraph (b) (1) of that section. (7) crystallinity. Proceed as directed in i 141.504(a) of this chapter. 5 ISOr.ll Minocycline hydrochloride capsules. - (a) Requirements for certification- ill Standards of identity, strength, quality, and parity. Minocycline hydro chloride capsules are composed of mino cycline hydrochloride and one or more suitable and harmless lubricants and dil uents enclosed in a gelatin capsule. Each capsule contains minocycline hydro chloride equivalent to 100 milligrams of minocycline. Its potency Is satisfactory If It Is not less than 90 percent and not more than 115 percent of the number of milligrams of minocycline that it is rep resented to contain. Its moisture content is not more than 12 percent. The mino cycline hydrochloride used conforms to the standards prescribed by 1150g.Ua) (1). (2) Labeling. It shall be labeled in ac cordance with the requirements of 3 148.3 of this chapter. (3) Requests for certification; sam ples. In addition to complying with the requirements of 114S.2 of this chapter, each such request shall contain: . (1) Results of tests and assays on: (a) The minocycline hydrochloride used in making the batch for potency, safety, moisture, pH, minocycline con tent, identity, and crystallinity. (b) The batch for potency and moisture. (11) Samples required: (a) The minocycline hydrochloride nsed in making-the batch: 10 packages, each containing approximately 300 milligrams. <b> The batch: A minimum of 30 capsules. (b) Tests and methods of assay--(1) Potency. Proceed as directed in 1141.111 of this chapter, preparing the sample for assay as follows: Place a representa tive number of capsules into a high-speed glass blender Jar with sufficient O.Ut hydrochloric acid to give a stock solution of convenient concentration , containing not less than 150 micrograms of mino cycline per milliliter (estimated). Blend for 3 to 5 minutes. Remove an aliquot and further dilute with 0.Uf potassium phosphate buffer, pH 44 (solution 4), to the reference concentration of O.1C0 microgram of. minocycline per milliliter (estimated). . (2) Moisture. Proceed aa directed In 1 141.502 of this chapter. Data supplied by the manufacturer concerning the subject antibiotic have been evaluated. Since the conditions pre requisite to providing for its certification have been complied with and sxcc not delaymg in so providing is In the public interest, notice and public procedure anl delayed effective date are not prerequi sites to-this promulgation. Effective date. This order snail be ef fective upon publication in the Federal Register (12-7-71). (Sec. 507, S9 Scat. 453, as amended; 21 T7A.C. 357) Dated: November 21, 1971. H. E. Simmons, Director, Bureau of Drugs. [FR Doc.71-17773 FUed 12-5-71;8:45 am] ' Title 29--LABOR Chapter X'.H--Bureau of labor Standards, Department of Labor PART 1513--SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Standard for Exposure to Asbestos Dust Pursuant to section 4(b) (2) of the Williams-Sceiger Occupational Safety and Health Act of 1970 (24 Stat. 1592. 29 TJ.S.C. 653), 3 1518.55 of Title 29. Code of Federal Regulations. Is hereby amended in the manner indicated be low in order to prescribe a new stand ard. limiting the exposure of workers to asbestos dusk The new standard limit ing the exposure of employees to asbes tos dust is that adopted under section 6(c) of the 7TU1larns-Steiger Occupa tional Safety and Health Act of 1970 and published in the Federal Register on this date. The standard is hereby de termined to be more eCective than that presently provided under 31513.55 to the extent that it prescribes minimum levels of exposure to asbestos dust. Therefore, by operation of section 4(b) (2) of the Act the new standard issued under section 6(c) supersedes the con struction safety standard relating to ex posure to asbestos dust. Section 1518.55 is hereby amended by adding a new paragraph (c) thereto. As amended ! 1318.55 reads as follows: 1318.53 Cues, vapors, fames, dusts, and mills. (c) Paragraphs (a) and (b) of this sec tion do not apply to the exposure of em ployees to airborne asbestos dust. When ever any. employee Is exposed to airborne asbestoe dust, the requirements of } 1910.93a of this title shall apply. Effective date. This amendment shall become effective upon publication in the Federal Register (12-7-71). (See. 4(b) (3), 84 Stat. 1593. 29 UA.C. 653; Secretary's Order No. 1>-71,36 FA, 8754) Sirued at Wasliir.gtcn. D.C. this 2d day of --'Occmber 1571. G. c. GnsTti", Assistant Secretary of La'e [FB Doc.71-17335 F:IM 12-5-71:8:47 t-- | Chapter XVII--Occupational Safety and Health Administration, Cepcitment of Labor PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Emergency Standard for Exposure to Asbestos Dust Pursuant to section 6(c) of the 'Wil liams-Steiger Occupational safety and Health Act of 1970 '84 stat. 1556. 29 U.S.C. 655), Pan 1910 of Title 29. Cede of Federal Regulations '35 P.R. 1C455. May 29, 1971) is hereby amended in the manner indicated below in order to pro vide an emergency standard dealing with the exposure of employees to asuestes dust. In light of increasing information cn the resuits of exposure of employees to airborne asbestos dust, including recent studies by the National Institute for Oc cupational Safety and Health and ethers, and recommendations by the American Conference of Governmental Ir.duttrtal Hygienists (ACGDJ). it Is hereby determm.ed that (l) exposure under the pres ent standard for asbestos dust in Table G-3. i 1910.93. of 12 fibers per miliilicer greater than S microns In length or 2 million particles per cubic foot of air. which Is derived from an established Fed eral standard promulgated under tr.e Waish-Heaiey Public Contracts Act on May 20. 1969, constitutes a grave danger to employees exposed to this 3-hour time-weighted average concentration; and that (2) an emergency standard is necessary to protect employees from this excessive exposure. The National Insti tute for Occupational Safety and Health concurs that the proposed change x the asbestos dust standard recommended by the American Conference of Governmen tal Industrial Hygienists should be the substantial base for the emergency standard. Action concerning the standard will be commenced under section 6(b) in the immediate future. Any notice of pro posed rulemaking under section 6ib> will give notice of the emergency stanu-irti as a proposed role and also of any ap propriate subsidiary progcsals which may be required under subparamaphs <5) and (7) of section 6(b) relating to the ex posure of employees to toxic substances. Part 1910 is amended as follows: L. Table G-3 following 31910.33 '36 PR. 15104. Aug. 13, 1371) is hereby amended by deleting the following: Asbestos--12 fibers per mJUUlter greater thvx 8 micron* in length or_____ .... 3 Mppcf. TrecaoUt*3 MppcT. 2Cmg./M %StO, No. 235----- 3 FEDERAL REGISTER, VOL. 38, NO. 234--TUESDAY, DECEMBER 7, 1971 0006129 . 2^20$ RULES AND REGULATIONS I as amended. Table G-3 reads as follows: ' ", TAltX G-J--McilJUl DUSTS Substance Hpprf* BQleai l i. Crystalline: Qnsrti (respirable) '. Qnartt (total dost) ISO I IOieeM* %910rf rPSrOTJ-3 __________ 30a&-U> CristobeUte: T?a if tbs slue caltalsled boa tba coant or mus toratline Cor quarts. Tndyoiu: Use if tba Telue calculated from tba (ormaiao tor quarts. Amorphous, taolu-fio* oatural dlatomaceoua earth.......... %3,0+I 20 Mmelt* rsiOi Silicates (less than 15$ crys tallise silca): S Mica................................... Soapstone.............. ............ . ' Talc........................................ Portland cement........... Graphite (natural!.................. Coal dust (resotrable traction las than i% SiOs)................ . Tor more than i% 3(Ot_......... . 20 20 20 M li .... 2.4aebP or __ lomt'it* . Inert or Nuisance Dust: Respirable traction___ Total dust___________ 15SIOH-2 t6 Sme'M* SO lime-M* Not*: Conversion (actors-- mppcCX3S.3mtliion particles per cubic meter --particles per e.e. Millions of particles per cubic foot of air. based on taplnjer samples counted by ii;!it-f.e!d technics. The perceauqe of crystalline silica Ut the formula b the aasnnt determined from sir-borne nmole*, ex cept In those instances in which other methods bare been shown to be applicable. i As determined by the membrane filter method st OOXphase centrist mcEnificatiuo. Both ceneentratlon and percent quirts (or the appli cation of this limit are to be determined (rea the (rac::oa passing a slse-wiector with the following characteristics: Aerodynamic diameter (onlt density sphere) Percent passing selector 2 IS Va. 3.5 0 10 - 90 7so5 35 0 The measurements under this note refer to the use of an A EC Instrument. If the respirable fraction of coni dnst Is determined with a.MP. E the firurc corresponding to that of 2.1 Mg,`M> ta the tabie for coat dust is 4.4 Mi, Mj 2. A aew i 1910.93a is added to Part 1910. The new 31910.93a reads as follows: 1910.93a Asbestos dust. (a) The 8-hour time-weighted aver age airborne concentration of asbestos dust to which employees are exposed shall not exceed S fibers per milliliter greater than 5 microns in length, as de termined by the membrance filter method at 400-450 x magnification (4 millimeter objective) phase contrast illumination. Concentrations above 5 fibers per milliliter but, not to exceed 10 fibers per milliliter, may be permitted up to a total of 15 minutes in an hour for up to 5 hours in an 8-h'our day. (b) Engineering methods, such as but not limited to, enclosure, vacuum sweep ing, and local exhaust ventilation, shall be used to meet the exposure limits pre scribed in paragraph (a) of this section. Where such engineering methods are not feasible, or do not otherwise reduce the concentrations below those prescribed in paragraoh (a) of this section, respira tory protective devices shalt be provided and used in accordance with paragraph (c) of this section. (c) (1) (i) When the limits of ex posure to asbestos dust prescribed in paragraph (a) of thus section are ex ceeded and when engineering controls required by paragraph ib) of this section are not feasible or do not otherwise re duce the concentration of asbestos dust below those prescribed in paragraph (a) of this section, the employer shall re quire the use of respiratory protective de vices. The selection of respiratory protective devices shall be limited to those specified in the remamir.g sub paragraphs of this paragraph (c). (ii) The employer shall require that each employee test his respiratory pro tective device before each use in order to insure a proper fit according to the manu'acturer's instructions. The em ployer shall further provide for effective training or supervision of employees in the testing of respiratory protective de vices for fit before their use. (2) For an atmosphere containing not more than 25 fibers per milliliter greater than 5 microns in length over an 8-hour average, or more than 50 fibers per milli liter over any period of 15 mmutes, a reusable or single-use filter type respira tor, operating with negative pressure during the inhalation phase of breathing, approved by the D.S. Bureau of Mines under the provisions of 30 CFR Part 14 (Bureau of Mines Schedule 21B), or a valveless respirator providing equivalent protection, shall be used. (3) For an atmosphere containing not more than 250 fibers per miliiiter greater than 5 microns In length over an 8-hour average, or more than 500 fibers per milliliter over any period of 15 minutes, a powered filter positive pressure res pirator approved by the LT.S. Bureau of Mines under the provisions of 30 CFR Part 14 (Bureau oi Mines Schedule 21B) shall be used. (4) For an atmosphere containing more than 250 fibers per milliliter greater than 5 microns in length over an 8-hour average a type C positive pres sure supplied-air respirator approved b7 the UB. Bureau of Mines under the pro visions of 30 CFR Part 12 (Bureau of Mines Schedule 19B) shall be used. (5) Hie employer shall establish a respirator program in accordance with the requirements of American National Standard Practice for Respiratory Pro tection Z88.2--1909. (6) The respirators provided each em ployee shall be properly inspected, cleaned, repaired and stored. (d) (1) When an employer has em ployees who are exposed to asbestos dust exceeding the limits prescribed in para graph (a) of this section and the ex posure results from the operations de scribed In the remaining subparagraphs of this paragraph (d), the i-jv/loyer shall comply the requirements af these subpara,. _?m. relating to the cperaticr.s involved. The requirements of t;_s para graph are in addition to those preset. :ed in paragraph (b) of this section. <2> All hand- or power-operated tools which produce asbestos dust such as. but not limited to. saws, scorers, abrasive wheels, and drills shall be provided with local exhaust ventilation ar.d dust col lectors in accordance with the American National Standard Fundamentals Gov erning the Design and Operation of Local Exhaust Systems: ANSI Z3.2--1971. (3) Employees exposed to the spraying of asbestos or the demolition of pipes, structures, or equipment covered or in sulated with asbestos shall be provided with respiratory protective devices in accordance with paragraph (c)(4) of this section.. * (e) Asbestos cement, mortar, coatir.ss. grout, and plaster shall be mixed in closed bags or other containers. (f) Asbestos waste and scrap shall be collected and disposed of in sealed bags or other containers. (g) Ail cleanup of asbestos dust and blowing shall be performed by vacuum cleaners. No dry sweeping shall be per formed. 3. Section 1910.12 Is amended by changing paragraph (a) in order to apply the emergency standard prescribed In tne new } 1910.93a, which is published in this document, to construction work which is subject *0 the Act. The amendment is necessary 'n light of ti.e rule of reguia- tory construction set forth in 31910.5(c). As amendod, 11910.12 reads as follows: 1910.12 Construction work. (a)(1) Adoption and extension of es tablished safety and health standards for construction. The standards pre scribed by Part 1518 of this title and in effect on April 28. 1971. are adopted as occupational safety or health standards under section 6(a) of the Act and shall apply, according to the provisions thereof, to every employment and place of employment of ever/ employee en gaged in construction work. Each em ployer shall protect the employment and places of employment of each of h:s employees engaged in construction work by complying with the appropriate standards prescribed b7 this paragraph. (2) The standards prescribed in 11518.55(0 of this title shall apply in the case of the exposure of any em ployee in construction work to airborne asbestoc dust. Effective date. These amendments shall become effective immediately upon publication in the Federal Register (12-7-71). (Sec. 6(e). M Stat. 1898. 29 T7.S.C. 835; Sec retary'* Order No. 12-71,38 Fit. 8754) Signed at Washington, D.C., this 2d day of December 1971. G.C. Guenther, Assistant Secretary of Eabor. tER Doc.71-17833 Filed 12-9-71:8:47 am] FEDERAL REGISTER, VOL 36, NO. 234--TUESDAY, DECEMBER 7, 1*7! f, 0006130