Document O3nrYo2qKK8JbZe8B84XqXXZX

7~<Q -- -- AAe. OI /?. 22) '/?*e/<so<j^ pfA s2. <^S~rZ/x/S&*J &S. M A?* / 9/ O. 9 3 cl. A 22)u^ / 'S<5Z7&S ^2cPZ?y<yc-y AA?saJ~. Ca&/2ez/7'<c <S _.__ ^LT/>eZ^L /4_____ Z'A/?(Zsi'/s^>/. -7Z> /s-/3c//LS?7~g' /s t'WlsT' -So Z> cSs-S C*=2- C '~7~D^ &___ ---____ p/<r _________ s-/&T~T5_____ -rz> ________ -7~s/z2' ^xj^csu/zer_____~ro _ ZZ&=PE72.rtuJjg~_______ PP' 7^/^"_______ ________ _____________________/Cj6&SA? ss c&4jr7s /=& p&<e y_______ -tps/s i//CLz~ _._________ _______________________________________ ______________________ ._.. ______ ___ ETC 15604 ^-00336 RULES AND REGULATIONS 23207 To be a valid assay, the percent column recovery should be 1002 percent. (6) Identity. Proceed as directed in 141.521 of this chapter, using a 0.5 percent potassium bromide disc prepared as described in paragraph (b)(1) of that section. (7) Crystallinity. Proceed as directed in 9 141.504(a) of this chapter. 150p.ll Minocycline hydrochloride capsules. (a) Requirements for certification-- (1) Standards of identity, strength, quality, and purity. 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. Xls 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 9 loOg.l(a) (1). (2) Labeling. It shall be labeled in ac cordance with the requirements of 9 148.3 of this chapter. (3) Requests for certification; sam ples. In addition to complying with the requirements of 9 146.2 of this chapter, each such request shall contain: (1) Results of tests and assays on: (a) The minocycline hydrochloride used in making the batch lor potency, safety, moisture, pH. minocycline con tent, identity, and crystallinity. (b) The batch for potency and moisture. (ii) Samples required:. (a) The minocycline hydrochloride used 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 9 141.111 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 0.1N hydrochloric acid to give a stock solution of convenient concentration containing not less than 150 micrograins of mino cycline per milliliter (estimated). Blend for 3 to 5 minutes. Remove an aliquot and further dilute with 0.1AT potassium phosphate buffer. pH 4.5 (solution 4), to the reference concentration of 0.100 microgram of minocycline per milliliter (estimated). (2) Moisture. Proceed as directed in 9 141.502 of tills 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 since not delaying in so providing is in the public interest, notice and puulic procedure anl delayed effective date are not prerequi sites to this promulgation. Effective date. This order shall be ef fective upon publication in the Federal Register (12-7-71). (Sec. >07. 59 Stat. 453. as amended: 21 U.S.C. 357) Dated: November 21, 1971. H. E. Simmons, Director, Bureau of Drugs. [Fit Doc.71-17773 Filed 12-0-71:8:45ami Title 29--LABOR Chapter XIII--Bureau of Labor Standards, Department of Labor PART 1518--SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Standard for Exposure to Asbestos Dust Pursuant to section 4(b) (2) of the Williams-Steiger Occupational Safety and Health Act of 1970 (84 Stat. 1592, 29 U.S.C. 653), 9 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 dust. The new standard limit ing the exposure of employees to asbes tos dust is that adopted under section 6(c) of the Williams-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 effective than that presently provided under 91518.55 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 uuder 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 9 1518.55 reads as follows: 1518.55 Cases, vapors, fumes, dusts, and mists, * (c) Paragraphs (a) and (b) of this sec tion do not apply to t lie exposure of em ployees to airborne asbestos dust. When ever any employee is exposed to airborne asbestos dust, the requirements of i 1310.93a of this title shaii apply. Effective date. This amendment shall become effective upon publication in the Federal Recister (12-7-71). (Sec. 4(b)(2). St Stat. 1592. 29 CT.S.C. 653; Secretary's Order No. 12-71,38 PUL 8754) Signed at Washington, D.C.. this 2d day of December 1971. G. C. Guenther, Assistant Secretary of Labor. [FR Doc.71-17835 Filed 12-6-71:8:47 am) Chapter XVII--Occupational Safety and Health Administration, De partment of l_frqr , , ------------ 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. 1596. 29 U.S.C. 655), Part 1910 of Title 29. Code of Federal Regulations (36 F.R. 10466, 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 asbestos dust. In light of increasing information cn the results of exposure of employees to airborne asbestos dust, including recent studies by the National Institute for Oc cupational Safety and Health and others, and recommendations by the American Conference of Governmental Industrial Hygienists (ACGIH), it Is hereby deter mined that (1) exposure under the pres ent standard for asbestos dust in Table G-3, 9 1910.93, of 12 fibers per milliliter greater than 5 microns in length or 2 million particles per cubic foot of air, which is derived from an established Fed eral standard promulgated under the Walsh-Healey Public Contracts Act on May 20, 1969, constitutes a grave danger to employees exposed to this 8-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 in 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 6(b) will give notice of the emergency standard as a proposed rule and also of any ap propriate subsidiary proposals which may be required under subparagraphs (5) and (7) of section 6(b) relating to the ex posure of employees to toxic substances; Part 1910 is amended as follows: 1. Table G-3 following 9 1910.93 (36 PH. 15104, Aug. 13, 1971) is hereby amended by deleting the following: Asbestos--12 fibers per mlUillter greater than 5 microns la length or2 Mppcf. TromoUte5 Mppcf. 30rog./M* ,FEDERAL REGISTER, VOL 34, NO. 734--TUESDAY, DECEMBER 7 1971 No. -00337 ETC 15605 32(58 RULES AND REGULATIONS As amended. Table G-3 reads as follows: Tadlx G-3--Mrsiui Dusts 3ubstar.ee Mppcf Mg/M* jmIUa: Crystalline: Quart.* (respirable)............... CIO* lflrag,M <5SK>+ 7^tOH-2 Quailt (total dust)................................... Wmc/M* CriMobalite: Fre H the Titluc calculated from the < ount or inass formulae for quart!. Traiymite: T'se Y\ the value c alculated from ibe for* rnulae for quartz. Amorphous, including natural 'llatotnacoous earth.................. 9cSjOt+2 20 SOing/M* TcSiCj Silicates fleets than l% cry> inllino siilca): Mica...................................... Soapstone......... .............. .. Talc....................................... Portland cement.................. Graphite fr.atural).................. Coat dust (rcspitable fraction less than 5% SiOi).............. . For more than 5% SiO.......... Inrrt or N'liisonce Dust: Respirable fractloo___ Total dust................... 20 20 20 50 15 ___ ?.4iug/M> or ___ lOmg/M* %StOH-2 15 5mg/M* 50 Umg/M* Mot*: Conversion factors-- mppcfXM.I-mlilion particles per cubic meter particles per c.c. Millions of particles per cubic foot of air, based on Lmpinger samples counted by light*field technics. The percentage ol crystalline siilca In the formula is the amount determined from airborne samples, ex cept in those instances in which other methods have been shown to be applicable. As determined by tbe membrane filter method at &iXPhase contrast maciuflcatUm. m Doth concentration and percent quarts for the appli cation of this limit are to he determined from the fraction passtiig a size-selector with the following characteristics: Aerodynamic diameter (unit density sphere) Percent passing selector 2 2.5 3.5 5.0 10 00 75 SO 25 0 The measurements under this note refor to the use ol an aEC instrument. If the respirable fraction ol coal dust is determined with a MRE tbe figure corresponding to that of 2.4 Mg/M* in the table for coal dust is 4.5 Mg/M, 3. A new 1910.93a la added to Part 1910. The new 91910.93a reads as follows: 1910.93a Asbestos dust. (a) The 8-hbur time*weighted aver age airborne concentration of asbestos dust to which employees are exposed shall not exceed 5 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-hour day. lb) 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 nos feasible, or do not otherwise reduce the concentrations below those prescribed in paragraph (a) cf this section, respira tor:-' protective devices shall be provided and used in accordance with paragraph (O of this section. (c) (1) (it When the limits of ex posure to asbestos dust prescribed In paragraph (a) of this section arc ex ceeded and when engineering controls required by paragraph lb) cf 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 remaining subparagraphs of this paragraph (c). (il) 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 manufacturer's instructions. The em ployer shall further provide for effective training or supervision of employees in tile 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 minutes, a reusable or single-use filter type respira tor, operating with negative pressure during the inhalation phase of breathing, approved by the U.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 mlllilter 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 U.S. Bureau of Mines under the provisions of 30 CFR Part 14 (Bureau of 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 by the U.S. Bureau of Mines under the pro visions of 30 CFR Part 12 (Bureau of Mines Schedule 19B) shall be used. (5) The employer shall establish a respirator program in accordance with the requirements of American National Standard Practice for Respiratory Pro tection Z38.2--1969. (6) The respirators provided each em ployee shall be properly inspected, cleaned, repaired and stored. (d) (1) When an employer has em ployees who axe 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 employer shall comply with the requirements of these subparagraphs relating to the operations involved. Tlie requirements of this para graph are in addition to those prescribed in paragraph tb) of this section. cl) All hand- nr 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 and dust col lectors in accordance with the American National Standard Fundamentals Gov erning the Design and Operation of Local Exhaust Systems; ANSI 29.2--1971. (3) Employees exposed to the spraying of asbestos or the demolition oi pipes, structures, or equipment covered or in sulated with asbestos shall be provided with respiratory protective devises in accordance with paragraph (a)(4) of this section. (e) Asbestos cement, mortar, coatings, 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) All 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 the new 91910.93a. which Is published in thi3 document, to construction work which is subject to the Act. The amendment Is necessary in light of the rule of regula tory construction set forth In 9 1910.5(c). As amended, } 1910.12 reads as follows: 1910.12 Construction work. (a)(1) Adoption and extension of es tablished safety and health standards for construction. Tlie 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 every employee en gaged in construction work. Each em ployer shall protect the employment and places of employment of each of his employees engaged In construction work by complying with the appropriate standards prescribed by this paragraph. (2) The standards prescribed in 9 1518.55(c) of this title shall apply in the case of the exposure of any em ployee In construction work to airborne asbestos dust. Effective date. These amendments shall become effective immediately upon publication In the Federal Register (12-7-71). (See. 6(e), 84 9Ut. 1598. 29 US.C. 655: Sec retary's Order No. 13-71,36 F.R. 8754) ^Signed at Washington, D.C., this 2d day of December 1971. . G. C. Guenther, Assistant Secretary of Labor. IFR Doc.71-17833 Filed 13-6-71:8:47 am] FEDERAL REGISTER, VOL. 36, NO. 236--TUESDAY, OECEMtEt 7, 1971 ETc 15606 E-00338