Document MMkQJ9LaJ7bDQ7gRjkzRL5dV

RULES AND REGULATIONS 23207 To lie a valid assay, the percent column recovery should be 100 r.2 percent _<?> Identity. Proceed as directed to ' N.521 of this chapter, using a 0.5 j: nt potassium bromide disc prepared sv, 'described to paragraph lb' < D of that section. i.Tt Crystallinity. Proceed as directed to 141.504(a) of this chapter. 1545s;.1) Mincyciinr hyriroctiiorMie capsule*. 'a) Requirements for certification-- O) 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. Its potency is satisfactory if it is" not less than 30 percent and not, more than 1X5 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 5 ISOg.Ka) (1). (2) Labeling. It shall be labeled in ac cordance with the requirements of 148.3 of? this chapter. < 3 ' Requests for certification; sam ples. In addition to complying with the requirements of i 14(5.2 of this chapter, each such request shall contain: <i) Results of tests and assays on: <) The minocycline hydrochloride pesd In making the batch for potency, |y, moisture, pH, minocycline conJ, identity, and crystallinity. (b> The batch for potency and moisture. (ii> Samples required: to) The minocycline hydrochloride used, in making the batch: 10 packages, each containing approximately 300 milligrams. <b) The batch: A minimum of 30 capsules. i b> Tests and methods of assay--(1) Potency. Proceed as directed to 141.111 of this chapter, preparing toe sample for assay as follows: Place a representa tive number of capsules into a high-speedglass blender jar with sufficient 0.11Y hydrochloric acid to give a stock solution of convenient concentration containing not less than 150 micrograuis of mino cycline per milliliter (estimated), Blend for S to 5 minutes. Remove an aliquot and further dilute with O.lAf 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 to f 141.502 of tills chapter. Uvfca supplied by the manufacturer concerning the subject antibiotic have qssen evaluated. Since the conditions yre- requisite to piuvUUng 'for its certification have been complied with and since not delaying in so providing is to the public interest, notice ami public procedure an), delayed effective date are not prerequi sites to this promulgation. Effective dale. This order shall be ef fective upon publication in the Federal ftBClSTER i 13-7-71 ). iSec 507. 59 9tat 443. as amended; 21 t-'.S.C. 357; Dated; November 21, 1971. H. E. Simmons, Director, Bureau of Drugs. (PR Dor 71-17773 Piled 12-6-71;8 :45 am J Title 28--LABOR Chopter Xllt--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-Steieer Occupational Safety and Health Act of 1970 (84 Stttt. 1592, 29 U.S.C. 653), { 1.518.55 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(0 of the Wlliiams-Steiger Occupa tional Safety and Health Act of 1970 and published in the Fkmsbax. RxexsrxB on this onto. `Die standard is hereby de termined to be more effective than that presently provided under 5 1518.55 to toe extent that it prescribes minimum ieveis of exposure to asbestos dust. Therefore, by operation of section. 4(b) (2) of toe 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 I 1518.55 reads as follows: 5518.55 Cases, vapors, futures, duals, and. tutor?. d * * * <s (c) Paragraphs (a) and (b) of tills sec tion do not apply to the exposure of em ployees to airborne asbestos dust. When ever any.employee is exposed to airborne asbestos dust, the requirements of 5 1910.33a of (ills title shall api>ly. Effective date. This amendment shall become effective upon publication in the Federal Register (12-7-71). (See. 4fb)(3!, S4 Stat. IBM, 29 U.S.C. 653; Secretary's Order No. 12-71, 86 FA 8764) Signed at Washington, D.C., this 2d day of December 1971, G. C, Guenther, . Assistant Secretary of Labor. |.1''R Doc.71-17835 Filed } 2-6-71:8:47 am I Chapter XVlt--Occupational Safely and Health Administration, De partment of Labor PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS Emergency Standard for Exposure to Asbestos Dust Pursuant to section 6(c) of the Williams-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 on 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 0-3, 5 1910.93, of 12 fibers per milliliter greater than 5 microns to length or 2 million particles per cubic foot of ear. 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 toe 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. Fart 1910 is amended as follows: 1. Table G-3 following 1910.93 (36 F.B. 15104, Aug. 13, 1971) .is hereby amended by deleting the following: Asbestos--12 fibers per milliliter greater than 5 microns in length or2 Mppof. Troinollte 6 Mppd. SSOmg./M5 "%sior h. irvi..... FEDERAL REGISTER, VOL. 36, NO. 234--TUESDAT, DECEMBER 7, 19/1 HWBUI0004859 23208 RULES AND REGULATIONS As amended., Table G-'3 reads as be used to meet Use exposure limits pre follows: scribed in paragraph (a) of this section. TAftl.R 0--3'--M(N KC.f I. T(!!:mS Where such engineering methods are not feasible, or do not otherwise reduce the 3ub:il-ancA Mppef IM&'iVP concentrations below those prescribed in paragraph (a.> of this section, respira Silica; Cryateilin: 4nr*rtz (r`Vcpiriil..i<`) ............. tory protective devices shall be provided and used in accordance with paragraph -i60 1 I0mg/M*8 5 * * <c) of this section. %8iO*+6 %8S0H-^ (e)(I) c-i) When the limits of ex Q,i.mrU (tetei <lusO.................................. 30mg/M* posure to asbestos dust prescribed in Crishobalit*?: TJs Y) the vnlur- calculated from thefiourit or mass fornmUtu for niiftrU. Tnctymtte: TJs 1$ tho value calculated from the for mula for quarU. Amorphous, Including natural (Jiatomaceous earth.............. %S?Os ! `2 paragraph (a) of this section are ex ceeded and when engineering controls required by paragraph < b > 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 20 ff>in^/M'3 quire the use of respiratory protective de %SiOt vices. The selection of respiratory Silicates 0ts than )% crys- Uvlliuo silica): Mica..,..... ......................... . 20 . Soapstone___________ `Ai Talc........... ...... Portland conmnt..... ............ 20 60 Graphite (natural).................. 16 Goal dust iresplrablA fraction less than 6% SiOjl..................................... For more than !>% BlOj.......................... . sMiug/M* or lOrag/M3 protective devices shall be limited to those specified in the remaining subparagraphs of this paragraph < c >, <ii) The employer shall require that each employee test his resphatory pro tective device before each use in order to insure a proper fit according to the manufacturer's instructions. Tire em ployer shall further provide for effective Inert or Nuisance Dust: Urapirable fraction............... Totel dust................. ..........- %8iO?4-2 training or supervision of employees in 16 Sing/M3 the testing of respiratory protective de 60 16idj*/Ms vices for fit before their use. (2) For an atmosphere containing not Note: Conversion factors-- H3ppcfX36-3"Trj.HHon jmrlio.lcs }>cr cubic inHer ^particles per c.c. * Millions of particles rxr cubic foot of air, based on tinplnger samples counted by Hght-floM technics. * The percentago of cryst&Uine silica in the formula is the amount determined from air-homo samples, oicept In those! nstancos In* which other method? h ave bon shown to bo applicable. i A# determined by the membraae filler method at 430xphase contrast ms$uifieaUon. * Bote concentration and percent quartz for the appli cation of this limit are to be determined from the fraction passing a size-selector with the following characteristics: more than 25 fibers per milliliter greater than 5 microtis 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 Mums Schedule. 2 IB), or a valveless respirator providing equivalent protection, shall be used. Aerodynamic diameter (uttlt domity sphere) Percent passing selector (3) For an atmosphere containing not more than 250 fibers per millilter greater than 5 microns in length over an 8-hour 2 5 on 75 average, or more than 500 fibers per milliliter over any period of 15 minutes, 11. ft Ml a powered filter positive pressure res ft. 0 10 25 0 pirator approved by the U,S. Bureau of Mines under the provisions of 30 CFR The measurements under this note refer to the use of an AlSO instrument, ff tee respirable fraction of coal dost is determined with a MltE the figure uorrysiiomling to that of 2.4 Mg/M3 in. the table for coal dust is 4.5 Mg/Ms 2. A new 1910.93a is added to Part 1910. The new 1910.93a reads as follows: . 1910.93a Aab<`*tos dust. (a) The 8-hour time-weighted aver 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. 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 merrtbrance filter method at 400-450 X magnification (4 (5) The employer shall establish a respirator program in accordance with the requirements of American National Standard Practice for Respiratory Pro tection Z88.2--1969. (6) The respirators provided each em 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. (b) Engineering methods, such as but not limited to, enclosure, vacuum sweep 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 ing, and local exhaust ventilation, shall of this paragraph (cl), the employer shall comply with the requirements of these subparagraphs relating to the operations involved. The requirements of this para graph are in addition to those prescribed, in paragraph (b) of this section. <?,) 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 and dust col lectors in accordance with the American National Standard Fundamentals Gov erning the Design and Operation of Local Exhaust Systems; ANSI Z9.2--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 (e)(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 1910.93a, which is published in this 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 5 1910.5(c). As amended, 1910.12 reads as follows: 1.910.12 Construction work, (a)(1) Adoption and extension o/ 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 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 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. ** 9 * 6 Effective date. These amendments shall become effective immediately upon publication in the Feuer.m. Register (12-7-71). (Sec. 6(c), 84 stilt. 1596. 29 P.S.C. 665: Sec retary's Order No. 12-71, 30 F.K.. 87541 Signed at Washington, D.C., this 2d day of December 1971. G. O. Guenther, Assistant Secretary of Labor. JFK Doc.71-17833 Filed 12-6-71 ;8:47 am 1 FEDERAL REGISTER, VOL 36, NO, 234--TUESDAY, DECEMBER 7, 1971 HWBUI0004860