Document RjY0MjKVr6rpjq7ELL5Oz8kjE

RULES AND REGULATIONS 23207 To lie a valid assay, the percent column recovery should be 100 r.2 percent. 4?.! Identity. Proceed as directed hi -'"'"''H .521 0jf t-jus chapter, using a 0.5 ,'^fent potassium bromide disc prepared i;S'`described in paragraph <b> < l) of that section. (7) Crystallinity. Proceed as directed in I 141.504(a) of this chapter. I50g.ll Minocycline hydrochloride capsules. ia> Requirements /or 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. 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 minosycllne hydrochloride used conforms to ;he standards prescribed by 5 150g-l(a) ID. (2) Labeling. It shall be labeled in ac- lordance with the requirements of 148.3 >f this chapter. <3> Requests for certification; sam ites. In addition to complying with the -equirements of 146.2 of this chapter, :acb such request shall contain: <i'i Results of tests and assays on: (a) The minocycline hydrochloride jE&d in making the batch for potency, f-y, moisture, pH, minocycline con.J, identity, and crystallinity. (b> The batch for potency and noisture, (ii> Samples required: to) The minocycline hydrochloride ised in making the batch: 10 packages, :M,ch containing approximately 300 niiligrams. <b) The batch: A minimum of 30 lapsules. ib) Tests and methods of assay--(1) Potency. Proceed as directed in 5 141.111 it this chapter, preparing tire sample or assay as follows: Place a representaIve number of capsules into a high-speed (lass blender jar with sufficient 0.1N lydrocbloric acid to give a stock solution if convenient concentration containing lot less than 150 micrograms of rninoyoline per milliliter (estimated). Blend or 3 to 5 minutes. Remove an aliquot ind further dilute with 0AM potassium mosphate buffer, pH 4.5 (solution 4), to he reference concentration of 0.100 cterogram of minocycline per milliliter estimated). (21 Moisture. Proceed as directed in !4!.;i02 of this chapter, Data supplied by the manufacturer xincemiug the subject antibiotic have seen evaluated, Since the conditions pre requisite to m willing 'for its certification have been complied with and since not delaying in so providing is in the public interest, notice and public procedure an!, delayed effective date are not prerequi sites to this promulgation. effective date. This order shall be ef fective upon publication in the Federal Rkcisteb (12-7-71). (Sec 607, 59 St-ftt, 4.33, as amended; 21 VS C 357) Dated:, November 21, 1971. H. E. Simmons, Director, Bureau of Drugs. (PR Doe 11--17773 Piled 12-6-71;8:45 <un ! Title 20--LABOR Chapter XI84----Bureau of Lobor 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 Heal tti Act of 1970 (84 Stafc, 1592, 29 U.S.C. 653 ), $ 1518.55 of Title 2ft. 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 Wllliams-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 1518.55 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 5 1518.55 reads as follows: 1518.55 Cases!, vapors, fumes, dusts, and 4 ***d (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 asbestos dart, the requirements of 5 1910.93a of this title shall apply. Effective date. This amendment shall become effective upon publication in the Federal Register (12-7-71). {See. 4fb).'3), m stat. 1532, 29 TJ.S.C. 663; Seeretary's Order No. 12-71. 36 Fit. 8764) Signed at Washington, D.C., this 2d day of December 1971. G. C. Guenther, . Assistant Secretary of Labor. (FR Doc.71-17885 Filed 12-8-71:8:47 arnj Chapter XVII--Occupational Safety 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, f 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 hi 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 1910.93 (36 F.R. 15104, Aug. .13, 1971) ,4s hereby amended by deleting the following: Asbestos--12 fibers per milliliter greater than 5 microns In length, or2 Mppof. Tremollte 5 Mjppol, 20mg./M* "% sio~ JTra. 2: FEDERAl REGISTER, VOl. 36, NO. 234--TUESDAY, DECEMBER 7, 1971 ' 23208 RULES AND REGULATIONS ' As amended. Table G-3 reads as follows: TaM.E KiU ' T)l.!;'TS Sub;(.anc Mppcf Mg/M* Silica; Crystalline: Quarto (respirable)......... .. 260 1 , %8K>>+ Quart,i (total dust)............. ...................... Wmg/M* %8*OH-*2 SO-rag/M* CrlsfcobnUto: Use ^ the value' calculated from Che count, or mass formulae for quart?,. TrldymUe: TJso the value calculated Jroui the for mulae for quartz. Amorphous, Including natural dlatoraaccous earth.............. %-S3Os } ?. 20 gOmjj/M23 %8iOt Silicates Cicss than ]% crys talline silica): ................ ....... ..... Soapstone______________ Talc____ ______-..................... Portland cement. ___ ____ Graphite (natural)............ ....... Coal dust (rasniiabl*. fraction less than 6% SiOj)....................... For more than f>% 8lO................. 20 20 20 60 16 2.4ng/M* or l0rag/M3 Inert or Nuisance Bust: Unspir&ble fraction,............. Total dust............................- %SiO!+2 16 6mg/M* 50 Wing/M* Note: Conversion factors-- mppcfX&>-3-million particles i>cr cubic mater e= particles per c.c. Millions of particle per cubic toot of air, based on hnpinger samplos counted by Jlghtdlold kvhnjcs. * The percentage of crystalline siHoa in tho formula Is tho amount determined from air-borne samples, ex cept In those Instances in- which other -methods have bo*ti shown to be applicable. i As determined by the membrane filter method at 130xpb8se contrast magnification. Both concentration and percent quartz for the appli cation of this limit are to be determined from tho fraction passing a slw'-solector with the following characteristics: Aerodynamic diameter (unit density sphere) o 2.5 3.5 6.0 10 Percent passing selector 90 75 50 or. 1) Tbe measurements under this note refer to the use of an AEG instrument, ff the respirable fraction of coal dust Ls determined with sMBB the figure corresponding to that of 2.4 Mg/M7 in the table for coal dust Is 4.6 Mg/M, 2. A new 1910.93a is added to Part 1910. The new 1910.93a reads as follows: ,V 1910.93a Asbestos tlwst. <a) The 8-hour 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 membrunce 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. (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 iu paragraph (a) of this section. Where such engineering methods are not feasible, or do not otherwise reduce the concentrafctorw below those prescribed in paragraph (a) of this section, respira tory protective devices shall 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 this section are ex ceeded and when engineering controls required by paragraph ( b) of tills 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>. (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 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 CFH Part 14 (Bureau of Mines Schedule 2IB), or a valveless respirator providing equivalent protection, shall be used. (3) For an atmosphere containing not more than 250 fibers per millilter 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 CFH 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 CFH 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 Z88.2--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 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 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. . <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 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 (c)(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 1910.6(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. 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 eveiy 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. ***** Effective date. These amendments shall become effective immediately upon publication in the Ff.dfr.u, Register (12-7-71). (Sec. 6(c), PA Slat. 1596, 29 U.S.C. 665: Sec retary's OTCier No. 12-71, 3G F.R. 8754) Signed at Washington, D.C., this 2d day of December 1971. G. C. Guenther, Assistant Secretary of Labor. |FK Doo.7)-17833 Filed 12-6-71:8:47 am J FEDERAL REGISTER, VOL. 36, NO, 234--TUESDAY, DECEMBER 7, V971 HWBUI0004216