[Title 29 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2009 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          29


          Part 1910 (Sec.  1910.1000 to end of part 1910)

                         Revised as of July 1, 2009


          Labor
          



________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of July 1, 2009
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 29:
    SUBTITLE B--Regulations Relating to Labor (Continued)
          Chapter XVII--Occupational Safety and Health 
          Administration, Department of Labor (Continued)            5
  Finding Aids:
      Table of CFR Titles and Chapters........................     533
      Alphabetical List of Agencies Appearing in the CFR......     553
      Table of OMB Control Numbers............................     563
      List of CFR Sections Affected...........................     565

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 29 CFR 1910.1000 
                       refers to title 29, part 
                       1910, section 1000.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

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HOW TO USE THE CODE OF FEDERAL REGULATIONS

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OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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OBSOLETE PROVISIONS

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INCORPORATION BY REFERENCE

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This material, like any other properly issued regulation, has the force 
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approval is based are:
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    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
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    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
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the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

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    Raymond A. Mosley,
    Director,
    Office of the Federal Register.
    July 1, 2009.







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                               THIS TITLE

    Title 29--Labor is composed of nine volumes. The parts in these 
volumes are arranged in the following order: parts 0-99, parts 100-499, 
parts 500-899, parts 900-1899, part 1900-Sec.  1910.999, part 1910.1000-
end of part 1910, parts 1911-1925, part 1926, and part 1927 to end. The 
contents of these volumes represent all current regulations codified 
under this title as of July 1, 2009.

    The OMB control numbers for title 29 CFR part 1910 appear in Sec.  
1910.8. For the convenience of the user, Sec.  1910.8 appears in the 
Finding Aids section of the volume containing Sec.  1910.1000 to the 
end.

    Subject indexes appear following the occupational safety and health 
standards (part 1910), and following the safety and health regulations 
for: Longshoring (part 1918), Gear Certification (part 1919), and 
Construction (part 1926).

    For this volume, Jonn V. Lilyea was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.


[[Page 1]]



                             TITLE 29--LABOR




   (This book contains part 1910, Sec. 1910.1000 to end of part 1910)

  --------------------------------------------------------------------

          SUBTITLE B--Regulations Relating to Labor (Continued)

                                                                    Part

chapter xvii--Occupational Safety and Health Administration, 
  Department of Labor (Continued)...........................        1910

[[Page 3]]

          Subtitle B--Regulations Relating to Labor (Continued)

[[Page 5]]



CHAPTER XVII--OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT 
                          OF LABOR (CONTINUED)




  --------------------------------------------------------------------
Part                                                                Page
1910            Occupational Safety and Health Standards 
                    (Continued).............................           7
                Subject Index for 29 CFR Part 1910--
                    Occupational Safety and Health Standards         500

[[Page 7]]



PART 1910_OCCUPATIONAL SAFETY AND HEALTH STANDARDS (CONTINUED)--Table of 

Contents




                Subpart Z_Toxic and Hazardous Substances

Sec.
1910.1000 Air contaminants.
1910.1001 Asbestos.
1910.1002 Coal tar pitch volatiles; interpretation of term.
1910.1003 13 Carcinogens (4-Nitrobiphenyl, etc.).
1910.1004 alpha-Naphthylamine.
1910.1005 [Reserved]
1910.1006 Methyl chloromethyl ether.
1910.1007 3,'--Dichlorobenzidine (and its salts).
1910.1008 bis-Chloromethyl ether.
1910.1009 beta-Naphthylamine.
1910.1010 Benzidine.
1910.1011 4-Aminodiphenyl.
1910.1012 Ethyleneimine.
1910.1013 beta-Propiolactone.
1910.1014 2-Acetylaminofluorene.
1910.1015 4-Dimethylaminoazobenzene.
1910.1016 N-Nitrosodimethylamine.
1910.1017 Vinyl chloride.
1910.1018 Inorganic arsenic.
1910.1020 Access to employee exposure and medical records.
1910.1025 Lead.
1910.1026 Chromium (VI).
1910.1027 Cadmium.
1910.1028 Benzene.
1910.1029 Coke oven emissions.
1910.1030 Bloodborne pathogens.
1910.1043 Cotton dust.
1910.1044 1,2-dibromo-3-chloropropane.
1910.1045 Acrylonitrile.
1910.1047 Ethylene oxide.
1910.1048 Formaldehyde.
1910.1050 Methylenedianiline.
1910.1051 1,3-Butadiene.
1910.1052 Methylene Chloride.
1910.1096 Ionizing radiation.
1910.1200 Hazard communication.
1910.1201 Retention of DOT markings, placards and labels.
1910.1450 Occupational exposure to hazardous chemicals in laboratories.

Subject Index for 29 CFR Part 1910--Occupational Safety and Health 
          Standards



                Subpart Z_Toxic and Hazardous Substances

    Authority: Sections 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, and 657); Secretary of Labor's 
Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-
90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 
65008), or 5-2007 (72 FR 31160), as applicable.
    All of subpart Z issued under section 6(b) of the Occupational 
Safety and Health Act, except those substances that have exposure limits 
listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were 
issued under section 6(a) (29 U.S.C. 655(a)).
    Section 1910.1000, Tables Z-1, Z-2, and Z-3 also issued under 5 
U.S.C. 553, Section 1910.1000 Tables Z-1, Z-2, and Z-3 but not under 29 
CFR part 1911 except for the arsenic (organic compounds), benzene, 
cotton dust, and chromium (VI) listings.
    Section 1910.1001 also issued under section 107 of the Contract Work 
Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C. 553.
    Section 1910.1002 also issued under 5 U.S.C. 553 but not under 29 
U.S.C. 655 or 29 CFR part 1911.
    Sections 1910.1018, 1910.1029 and 1910.1200 also issued under 29 
U.S.C. 653.
    Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.

    Source: 39 FR 23502, June 27, 1974, unless otherwise noted. 
Redesignated at 40 FR 23072, May 28, 1975.



Sec. 1910.1000  Air contaminants.

    An employee's exposure to any substance listed in Tables Z-1, Z-2, 
or Z-3 of this section shall be limited in accordance with the 
requirements of the following paragraphs of this section.
    (a) Table Z-1--(1) Substances with limits preceded by ``C''--Ceiling 
Values. An employee's exposure to any substance in Table Z-1, the 
exposure limit of which is preceded by a ``C'', shall at no time exceed 
the exposure limit given for that substance. If instantaneous monitoring 
is not feasible, then the ceiling shall be assessed as a 15-minute time 
weighted average exposure which shall not be exceeded at any time during 
the working day.
    (2) Other substances--8-hour Time Weighted Averages. An employee's 
exposure to any substance in Table Z-1, the exposure limit of which is 
not preceded by a ``C'', shall not exceed the 8-hour Time Weighted 
Average given for that substance in any 8-hour work shift of a 40-hour 
work week.
    (b) Table Z-2. An employee's exposure to any substance listed in 
Table Z-2 shall not exceed the exposure limits specified as follows:
    (1) 8-hour time weighted averages. An employee's exposure to any 
substance

[[Page 8]]

listed in Table Z-2, in any 8-hour work shift of a 40-hour work week, 
shall not exceed the 8-hour time weighted average limit given for that 
substance in Table Z-2.
    (2) Acceptable ceiling concentrations. An employee's exposure to a 
substance listed in Table Z-2 shall not exceed at any time during an 8-
hour shift the acceptable ceiling concentration limit given for the 
substance in the table, except for a time period, and up to a 
concentration not exceeding the maximum duration and concentration 
allowed in the column under ``acceptable maximum peak above the 
acceptable ceiling concentration for an 8-hour shift.''
    (3) Example. During an 8-hour work shift, an employee may be exposed 
to a concentration of Substance A (with a 10 ppm TWA, 25 ppm ceiling and 
50 ppm peak) above 25 ppm (but never above 50 ppm) only for a maximum 
period of 10 minutes. Such exposure must be compensated by exposures to 
concentrations less than 10 ppm so that the cumulative exposure for the 
entire 8-hour work shift does not exceed a weighted average of 10 ppm.
    (c) Table Z-3. An employee's exposure to any substance listed in 
Table Z-3, in any 8-hour work shift of a 40-hour work week, shall not 
exceed the 8-hour time weighted average limit given for that substance 
in the table.
    (d) Computation formulae. The computation formula which shall apply 
to employee exposure to more than one substance for which 8-hour time 
weighted averages are listed in subpart Z of 29 CFR part 1910 in order 
to determine whether an employee is exposed over the regulatory limit is 
as follows:
    (1)(i) The cumulative exposure for an 8-hour work shift shall be 
computed as follows:

E = (Ca Ta+Cb Tb+. . 
    .Cn Tn)/8

Where:

E is the equivalent exposure for the working shift.
C is the concentration during any period of time T where the 
concentration remains constant.
T is the duration in hours of the exposure at the concentration C.

The value of E shall not exceed the 8-hour time weighted average 
specified in subpart Z of 29 CFR part 1910 for the substance involved.

    (ii) To illustrate the formula prescribed in paragraph (d)(1)(i) of 
this section, assume that Substance A has an 8-hour time weighted 
average limit of 100 ppm noted in Table Z-1. Assume that an employee is 
subject to the following exposure:

Two hours exposure at 150 ppm
Two hours exposure at 75 ppm
Four hours exposure at 50 ppm

    Substituting this information in the formula, we have

(2x150+2x75+4x50)/8=81.25 ppm

    Since 81.25 ppm is less than 100 ppm, the 8-hour time weighted 
average limit, the exposure is acceptable.

    (2)(i) In case of a mixture of air contaminants an employer shall 
compute the equivalent exposure as follows:

Em=(C1/L1+C2/
    L2)+. . .(Cn/Ln)

Where:

Em is the equivalent exposure for the mixture.
C is the concentration of a particular contaminant.
L is the exposure limit for that substance specified in subpart Z of 29 
CFR part 1910.

The value of Em shall not exceed unity (1).

    (ii) To illustrate the formula prescribed in paragraph (d)(2)(i) of 
this section, consider the following exposures:

------------------------------------------------------------------------
                                                  Actual
                                              concentration
                  Substance                     of 8-hour     8-hour TWA
                                                 exposure     PEL (ppm)
                                                  (ppm)
------------------------------------------------------------------------
B...........................................           500         1,000
C...........................................            45           200
D...........................................            40           200
------------------------------------------------------------------------

    Substituting in the formula, we have:

Em=500/1,000+45/200+40/200
Em=0.500+0.225+0.200
Em=0.925

Since Em is less than unity (1), the exposure combination is 
within acceptable limits.

    (e) To achieve compliance with paragraphs (a) through (d) of this 
section, administrative or engineering controls must first be determined 
and implemented whenever feasible. When such controls are not feasible 
to achieve full compliance, protective equipment or any other protective 
measures shall be used to keep the exposure of employees to air 
contaminants within the limits

[[Page 9]]

prescribed in this section. Any equipment and/or technical measures used 
for this purpose must be approved for each particular use by a competent 
industrial hygienist or other technically qualified person. Whenever 
respirators are used, their use shall comply with 1910.134.

                                     Table Z-1--Limits for Air Contaminants
----------------------------------------------------------------------------------------------------------------
                                                                          mg/m\3\ (b)
                 Substance                    CAS No. (c)    ppm (a) \1\      \1\           Skin designation
----------------------------------------------------------------------------------------------------------------
Acetaldehyde..............................         75-07-0       200          360
Acetic acid...............................         64-19-7        10           25
Acetic anhydride..........................        108-24-7         5           20
Acetone...................................         67-64-1      1000         2400
Acetonitrile..............................         75-05-8        40           70
2-Acetylaminofluorine; see 1910.1014......         53-96-3
Acetylene dichloride; see 1,2-
 Dichloroethylene.
Acetylene tetrabromide....................         79-27-6         1           14
Acrolein..................................        107-02-8         0.1          0.25
Acrylamide................................         79-06-1  ............        0.3    X
Acrylonitrile; see 1910.1045..............        107-13-1
Aldrin....................................        309-00-2  ............        0.25   X
Allyl alcohol.............................        107-18-6         2            5      X
Allyl chloride............................        107-05-1         1            3
Allyl glycidyl ether (AGE)................        106-92-3     (C)10        (C)45
Allyl propyl disulfide....................       2179-59-1         2           12
alpha-Alumina.............................       1344-28-1
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Aluminum, metal (as Al)...................       7429-90-5
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
4-Aminodiphenyl; see 1910.1011............         92-67-1
2-Aminoethanol; see Ethanolamine.
2-Aminopyridine...........................        504-29-0         0.5          2
Ammonia...................................       7664-41-7        50           35
Ammonium sulfamate........................       7773-06-0
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
n-Amyl acetate............................        628-63-7       100          525
sec-Amyl acetate..........................        626-38-0       125          650
Aniline and homologs......................         62-53-3         5           19      X
Anisidine (o-, p-isomers).................      29191-52-4  ............        0.5    X
Antimony and compounds (as Sb)............       7440-36-0  ............        0.5
ANTU (alpha Naphthylthiourea).............         86-88-4  ............        0.3
Arsenic, inorganic compounds (as As); see        7440-38-2
 1910.1018.
Arsenic, organic compounds (as As)........       7440-38-2  ............        0.5
Arsine....................................       7784-42-1         0.05         0.2
Asbestos; see 1910.1001...................           (\4\)
Azinphos-methyl...........................         86-50-0  ............        0.2    X
Barium, soluble compounds (as Ba).........       7440-39-3  ............        0.5
Barium sulfate............................       7727-43-7
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Benomyl...................................      17804-35-2
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Benzene; see 1910.1028....................         71-43-2
 
    See Table Z-2 for the limits
     applicable in the operations or
     sectors excluded in 1910.1028 \d\
 
Benzidine; see 1910.1010..................         92-87-5
p-Benzoquinone; see Quinone.
Benzo(a)pyrene; see Coal tar pitch
 volatiles..
Benzoyl peroxide..........................         94-36-0  ............        5
Benzyl chloride...........................        100-44-7         1            5
Beryllium and beryllium compounds (as Be).       7440-41-7  ............    (\2\)
Biphenyl; see Diphenyl.
Bismuth telluride, Undoped................       1304-82-1
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Boron oxide...............................       1303-86-2
    Total dust............................  ..............  ............       15
Boron trifluoride.........................       7637-07-2      (C)1         (C)3
Bromine...................................       7726-95-6         0.1          0.7
Bromoform.................................         75-25-2         0.5          5      X
Butadiene (1,3-Butadiene); See 29 CFR             106-99-0  1 ppm/5 ppm
 1910.1051; 29 CFR 1910.19(l).                                  STEL

[[Page 10]]

 
Butanethiol; see Butyl mercaptan.
2-Butanone (Methyl ethyl ketone)..........         78-93-3       200          590
2-Butoxyethanol...........................        111-76-2        50          240      X
n-Butyl-acetate...........................        123-86-4       150          710
sec-Butyl acetate.........................        105-46-4       200          950
tert-Butyl acetate........................        540-88-5       200          950
n-Butyl alcohol...........................         71-36-3       100          300
sec-Butyl alcohol.........................         78-92-2       150          450
tert-Butyl alcohol........................         75-65-0       100          300
Butylamine................................        109-73-9      (C)5        (C)15      X
tert-Butyl chromate (as CrO3); see               1189-85-1
 1910.1026 \6\.
n-Butyl glycidyl ether (BGE)..............       2426-08-6        50          270
Butyl mercaptan...........................        109-79-5        10           35
p-tert-Butyltoluene.......................         98-51-1        10           60
Cadmium (as Cd); see 1910.1027............       7440-43-9
Calcium carbonate.........................       1317-65-3
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Calcium hydroxide.........................       1305-62-0
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Calcium oxide.............................       1305-78-8  ............        5
Calcium silicate..........................       1344-95-2
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Calcium sulfate...........................       7778-18-9
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Camphor, synthetic........................         76-22-2  ............        2
Carbaryl (Sevin)..........................         63-25-2  ............        5
Carbon black..............................       1333-86-4  ............        3.5
Carbon dioxide............................        124-38-9      5000         9000
Carbon disulfide..........................         75-15-0  ............    (\2\)
Carbon monoxide...........................        630-08-0        50           55
Carbon tetrachloride......................         56-23-5  ............    (\2\)
Cellulose.................................       9004-34-6
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Chlordane.................................         57-74-9  ............        0.5    X
Chlorinated camphene......................       8001-35-2  ............        0.5    X
Chlorinated diphenyl oxide................      55720-99-5  ............        0.5
Chlorine..................................       7782-50-5      (C)1         (C)3
Chlorine dioxide..........................      10049-04-4         0.1          0.3
Chlorine trifluoride......................       7790-91-2      (C)0.1       (C)0.4
Chloroacetaldehyde........................        107-20-0      (C)1         (C)3
a-Chloroacetophenone (Phenacyl chloride)..        532-27-4         0.05         0.3
Chlorobenzene.............................        108-90-7        75          350
o-Chlorobenzylidene malononitrile.........       2698-41-1         0.05         0.4
Chlorobromomethane........................         74-97-5       200         1050
2-Chloro-1,3-butadiene; see beta-
 Chloroprene.
Chlorodiphenyl (42% Chlorine) (PCB).......      53469-21-9  ............        1      X
Chlorodiphenyl (54% Chlorine) (PCB).......      11097-69-1  ............        0.5    X
1-Chloro-2,3-epoxypropane; see
 Epichlorohydrin.
2-Chloroethanol; see Ethylene
 chlorohydrin.
Chloroethylene; see Vinyl chloride.
Chloroform (Trichloromethane).............         67-66-3     (C)50       (C)240
bis(Chloromethyl) ether; see 1910.1008....        542-88-1
Chloromethyl methyl ether; see 1910.1006..        107-30-2
1-Chloro-1-nitropropane...................        600-25-9        20          100
Chloropicrin..............................         76-06-2         0.1          0.7
beta-Chloroprene..........................        126-99-8        25           90      X
2-Chloro-6-(trichloromethyl) pyridine.....       1929-82-4
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Chromium (II) compounds.
    (as Cr)...............................       7440-47-3  ............        0.5
Chromium (III) compounds.
    (as Cr)...............................       7440-47-3  ............        0.5
Chromium (VI) compounds; See 1910.1026 \5\
Chromium metal and insol. salts (as Cr)...       7440-47-3  ............        1
Chrysene; see Coal tar pitch volatiles.
Clopidol..................................       2971-90-6

[[Page 11]]

 
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Coal dust (less than 5% SiO2), respirable   ..............  ............    (\3\)
 fraction.
Coal dust (greater than or equal to 5%      ..............  ............    (\3\)
 SiO2), respirable fraction.
Coal tar pitch volatiles (benzene soluble       65966-93-2  ............        0.2
 fraction), anthracene, BaP, phenanthrene,
 acridine, chrysene, pyrene.
Cobalt metal, dust, and fume (as Co)......       7440-48-4  ............        0.1
Coke oven emissions; see 1910.1029.
Copper....................................       7440-50-8
    Fume (as Cu)..........................  ..............  ............        0.1
    Dusts and mists (as Cu)...............  ..............  ............        1
Cotton dust \e\; see 1910.1043............  ..............  ............        1
Crag herbicide (Sesone)...................        136-78-7
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Cresol, all isomers.......................       1319-77-3         5           22      X
Crotonaldehyde............................       123-73-9;         2            6
                                                 4170-30-3
Cumene....................................         98-82-8        50          245      X
Cyanides (as CN)..........................           (\4\)  ............        5      X
Cyclohexane...............................        110-82-7       300         1050
Cyclohexanol..............................        108-93-0        50          200
Cyclohexanone.............................        108-94-1        50          200
Cyclohexene...............................        110-83-8       300         1015
Cyclopentadiene...........................        542-92-7        75          200
2,4-D (Dichlorophenoxyacetic acid)........         94-75-7  ............       10
Decaborane................................      17702-41-9         0.05         0.3    X
Demeton (Systox)..........................       8065-48-3  ............        0.1    X
Diacetone alcohol (4-Hydroxy-4-methyl-2-          123-42-2        50          240
 pentanone).
1,2-Diaminoethane; see Ethylenediamine.
Diazomethane..............................        334-88-3         0.2          0.4
Diborane..................................      19287-45-7         0.1          0.1
1,2-Dibromo-3-chloropropane (DBCP); see            96-12-8
 1910.1044.
1,2-Dibromoethane; see Ethylene dibromide.
Dibutyl phosphate.........................        107-66-4         1            5
Dibutyl phthalate.........................         84-74-2  ............        5
o-Dichlorobenzene.........................         95-50-1     (C)50       (C)300
p-Dichlorobenzene.........................        106-46-7        75          450
3,'-Dichlorobenzidine; see 1910.1007......         91-94-1
Dichlorodifluoromethane...................         75-71-8      1000         4950
1,3-Dichloro-5,5-dimethyl hydantoin.......        118-52-5  ............        0.2
Dichlorodiphenyltrichloroethane (DDT).....         50-29-3  ............        1      X
1,1-Dichloroethane........................         75-34-3       100          400
1,2-Dichloroethane; see Ethylene
 dichloride.
1,2-Dichloroethylene......................        540-59-0       200          790
Dichloroethyl ether.......................        111-44-4     (C)15        (C)90      X
Dichloromethane; see Methylene chloride.
Dichloromonofluoromethane.................         75-43-4      1000         4200
1,1-Dichloro-1-nitroethane................        594-72-9     (C)10        (C)60
1,2-Dichloropropane; see Propylene
 dichloride.
Dichlorotetrafluoroethane.................         76-14-2      1000         7000
Dichlorvos (DDVP).........................         62-73-7  ............        1      X
Dicyclopentadienyl iron...................        102-54-5
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Dieldrin..................................         60-57-1  ............        0.25   X
Diethylamine..............................        109-89-7        25           75
2-Diethylaminoethanol.....................        100-37-8        10           50      X
Diethyl ether; see Ethyl ether.
Difluorodibromomethane....................         75-61-6       100          860
Diglycidyl ether (DGE)....................       2238-07-5      (C)0.5       (C)2.8
Dihydroxybenzene; see Hydroquinone.
Diisobutyl ketone.........................        108-83-8        50          290
Diisopropylamine..........................        108-18-9         5           20      X
4-Dimethylaminoazobenzene; see 1910.1015..         60-11-7
Dimethoxymethane; see Methylal.
Dimethyl acetamide........................        127-19-5        10           35      X
Dimethylamine.............................        124-40-3        10           18
Dimethylaminobenzene; see Xylidine........
Dimethylaniline (N,N-Dimethylaniline).....        121-69-7         5           25      X
Dimethylbenzene; see Xylene.

[[Page 12]]

 
Dimethyl-1,2-dibromo-2,2-dichloroethyl            300-76-5  ............        3
 phosphate.
Dimethylformamide.........................         68-12-2        10           30      X
2,6-Dimethyl-4-heptanone; see Diisobutyl
 ketone.
1,1-Dimethylhydrazine.....................         57-14-7         0.5          1      X
Dimethylphthalate.........................        131-11-3  ............        5
Dimethyl sulfate..........................         77-78-1         1            5      X
Dinitrobenzene (all isomers)..............  ..............  ............        1      X
    (ortho)...............................        528-29-0
    (meta)................................         99-65-0
    (para)................................        100-25-4
Dinitro-o-cresol..........................        534-52-1  ............        0.2    X
Dinitrotoluene............................      25321-14-6  ............        1.5    X
Dioxane (Diethylene dioxide)..............        123-91-1       100          360      X
Diphenyl (Biphenyl).......................         92-52-4         0.2          1
Diphenylmethane diisocyanate; see
 Methylene bisphenyl isocyanate.
Dipropylene glycol methyl ether...........      34590-94-8       100          600      X
Di-sec octyl phthalate (Di-(2-ethylhexyl)         117-81-7  ............        5
 phthalate).
Emery.....................................      12415-34-8
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Endrin....................................         72-20-8  ............        0.1    X
Epichlorohydrin...........................        106-89-8         5           19      X
EPN.......................................       2104-64-5  ............        0.5    X
1,2-Epoxypropane; see Propylene oxide.
2,3-Epoxy-1-propanol; see Glycidol.
Ethanethiol; see Ethyl mercaptan.
Ethanolamine..............................        141-43-5         3            6
2-Ethoxyethanol (Cellosolve)..............        110-80-5       200          740      X
2-Ethoxyethyl acetate (Cellosolve acetate)        111-15-9       100          540      X
Ethyl acetate.............................        141-78-6       400         1400
Ethyl acrylate............................        140-88-5        25          100      X
Ethyl alcohol (Ethanol)...................         64-17-5      1000         1900
Ethylamine................................         75-04-7        10           18
Ethyl amyl ketone (5-Methyl-3-heptanone)..        541-85-5        25          130
Ethyl benzene.............................        100-41-4       100          435
Ethyl bromide.............................         74-96-4       200          890
Ethyl butyl ketone (3-Heptanone)..........        106-35-4        50          230
Ethyl chloride............................         75-00-3      1000         2600
Ethyl ether...............................         60-29-7       400         1200
Ethyl formate.............................        109-94-4       100          300
Ethyl mercaptan...........................         75-08-1     (C)10        (C)25
Ethyl silicate............................         78-10-4       100          850
Ethylene chlorohydrin.....................        107-07-3         5           16      X
Ethylenediamine...........................        107-15-3        10           25
Ethylene dibromide........................        106-93-4  ............    (\2\)
Ethylene dichloride (1,2-Dichloroethane)..        107-06-2  ............    (\2\)
Ethylene glycol dinitrate.................        628-96-6      (C)0.2       (C)1      X
Ethylene glycol methyl acetate; see Methyl
 cellosolve acetate.
Ethyleneimine; see 1910.1012..............        151-56-4
Ethylene oxide; see 1910.1047.............         75-21-8
Ethylidene chloride; see 1,1-
 Dichloroethane.
N-Ethylmorpholine.........................        100-74-3        20           94      X
Ferbam....................................      14484-64-1
    Total dust............................  ..............  ............       15
Ferrovanadium dust........................      12604-58-9  ............        1
Fluorides (as F)..........................           (\4\)  ............        2.5
Fluorine..................................       7782-41-4         0.1          0.2
Fluorotrichloromethane                             75-69-4      1000         5600
 (Trichlorofluoromethane).
Formaldehyde; see 1910.1048...............         50-00-0
Formic acid...............................         64-18-6         5            9
Furfural..................................         98-01-1         5           20      X
Furfuryl alcohol..........................         98-00-0        50          200
Grain dust (oat, wheat, barley)...........  ..............  ............       10
Glycerin (mist)...........................         56-81-5
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Glycidol..................................        556-52-5        50          150
Glycol monoethyl ether; see 2-
 Ethoxyethanol.
Graphite, natural, respirable dust........       7782-42-5  ............    (\3\)
Graphite, synthetic.......................

[[Page 13]]

 
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Guthion; see Azinphos methyl.
Gypsum....................................      13397-24-5
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Hafnium...................................       7440-58-6  ............        0.5
Heptachlor................................         76-44-8  ............        0.5    X
Heptane (n-Heptane).......................        142-82-5       500         2000
Hexachloroethane..........................         67-72-1         1           10      X
Hexachloronaphthalene.....................       1335-87-1  ............        0.2    X
n-Hexane..................................        110-54-3       500         1800
2-Hexanone (Methyl n-butyl ketone)........        591-78-6       100          410
Hexone (Methyl isobutyl ketone)...........        108-10-1       100          410
sec-Hexyl acetate.........................        108-84-9        50          300
Hydrazine.................................        302-01-2         1            1.3    X
Hydrogen bromide..........................      10035-10-6         3           10
Hydrogen chloride.........................       7647-01-0      (C)5         (C)7
Hydrogen cyanide..........................         74-90-8        10           11      X
Hydrogen fluoride (as F)..................       7664-39-3  ............    (\2\)
Hydrogen peroxide.........................       7722-84-1         1            1.4
Hydrogen selenide (as Se).................       7783-07-5         0.05         0.2
Hydrogen sulfide..........................       7783-06-4  ............    (\2\)
Hydroquinone..............................        123-31-9  ............        2
Iodine....................................       7553-56-2      (C)0.1       (C)1
Iron oxide fume...........................       1309-37-1  ............       10
Isoamyl acetate...........................        123-92-2       100          525
Isoamyl alcohol (primary and secondary)...        123-51-3       100          360
Isobutyl acetate..........................        110-19-0       150          700
Isobutyl alcohol..........................         78-83-1       100          300
Isophorone................................         78-59-1        25          140
Isopropyl acetate.........................        108-21-4       250          950
Isopropyl alcohol.........................         67-63-0       400          980
Isopropylamine............................         75-31-0         5           12
Isopropyl ether...........................        108-20-3       500         2100
Isopropyl glycidyl ether (IGE)............       4016-14-2        50          240
Kaolin....................................       1332-58-7
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Ketene....................................        463-51-4         0.5          0.9
Lead, inorganic (as Pb); see 1910.1025....       7439-92-1
Limestone.................................       1317-65-3
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Lindane...................................         58-89-9  ............        0.5    X
Lithium hydride...........................       7580-67-8  ............        0.025
L.P.G. (Liquefied petroleum gas)..........      68476-85-7      1000         1800
Magnesite.................................        546-93-0
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Magnesium oxide fume......................       1309-48-4
    Total particulate.....................  ..............  ............       15
Malathion.................................        121-75-5
    Total dust............................  ..............  ............       15      X
Maleic anhydride..........................        108-31-6         0.25         1
Manganese compounds (as Mn)...............       7439-96-5  ............     (C)5
Manganese fume (as Mn)....................       7439-96-5  ............     (C)5
Marble....................................       1317-65-3
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Mercury (aryl and inorganic) (as Hg)......       7439-97-6  ............    (\2\)
Mercury (organo) alkyl compounds (as Hg)..       7439-97-6  ............    (\2\)
Mercury (vapor) (as Hg)...................       7439-97-6  ............    (\2\)
Mesityl oxide.............................        141-79-7        25          100
Methanethiol; see Methyl mercaptan.
Methoxychlor..............................         72-43-5
    Total dust............................  ..............  ............       15
2-Methoxyethanol (Methyl cellosolve)......        109-86-4        25           80      X
2-Methoxyethyl acetate (Methyl cellosolve         110-49-6        25          120      X
 acetate).
Methyl acetate............................         79-20-9       200          610
Methyl acetylene (Propyne)................         74-99-7      1000         1650
Methyl acetylene-propadiene mixture (MAPP)  ..............      1000         1800

[[Page 14]]

 
Methyl acrylate...........................         96-33-3        10           35      X
Methylal (Dimethoxy-methane)..............        109-87-5      1000         3100
Methyl alcohol............................         67-56-1       200          260
Methylamine...............................         74-89-5        10           12
Methyl amyl alcohol; see Methyl isobutyl
 carbinol.
Methyl n-amyl ketone......................        110-43-0       100          465
Methyl bromide............................         74-83-9     (C)20        (C)80      X
Methyl butyl ketone; see 2-Hexanone.
Methyl cellosolve; see 2-Methoxyethanol.
Methyl cellosolve acetate; see 2-
 Methoxyethyl acetate.
Methyl chloride...........................         74-87-3  ............    (\2\)
Methyl chloroform (1,1,1-Trichloroethane).         71-55-6       350         1900
Methylcyclohexane.........................        108-87-2       500         2000
Methylcyclohexanol........................      25639-42-3       100          470
o-Methylcyclohexanone.....................        583-60-8       100          460      X
Methylene chloride........................         75-09-2  ............    (\2\)
Methyl ethyl ketone (MEK); see 2-Butanone.
Methyl formate............................        107-31-3       100          250
Methyl hydrazine (Monomethyl hydrazine)...         60-34-4      (C)0.2       (C)0.35   X
Methyl iodide.............................         74-88-4         5           28      X
Methyl isoamyl ketone.....................        110-12-3       100          475
Methyl isobutyl carbinol..................        108-11-2        25          100      X
Methyl isobutyl ketone; see Hexone.
Methyl isocyanate.........................        624-83-9         0.02         0.05   X
Methyl mercaptan..........................         74-93-1     (C)10        (C)20
Methyl methacrylate.......................         80-62-6       100          410
Methyl propyl ketone; see 2-Pentanone.
alpha-Methyl styrene......................         98-83-9    (C)100       (C)480
Methylene bisphenyl isocyanate (MDI)......        101-68-8      (C)0.02      (C)0.2
Mica; see Silicates.
Molybdenum (as Mo)........................       7439-98-7
    Soluble compounds.....................  ..............  ............        5
 Insoluble compounds.
       Total dust.........................  ..............  ............       15
Monomethyl aniline........................        100-61-8         2            9      X
Monomethyl hydrazine; see Methyl
 hydrazine.
Morpholine................................        110-91-8        20           70      X
Naphtha (Coal tar)........................       8030-30-6       100          400
Naphthalene...............................         91-20-3        10           50
alpha-Naphthylamine; see 1910.1004........        134-32-7
beta-Naphthylamine; see 1910.1009.........         91-59-8
Nickel carbonyl (as Ni)...................      13463-39-3         0.001        0.007
Nickel, metal and insoluble compounds (as        7440-02-0  ............        1
 Ni).
Nickel, soluble compounds (as Ni).........       7440-02-0  ............        1
Nicotine..................................         54-11-5  ............        0.5    X
Nitric acid...............................       7697-37-2         2            5
Nitric oxide..............................      10102-43-9        25           30
p-Nitroaniline............................        100-01-6         1            6      X
Nitrobenzene..............................         98-95-3         1            5      X
p-Nitrochlorobenzene......................        100-00-5  ............        1      X
4-Nitrodiphenyl; see 1910.1003............         92-93-3
Nitroethane...............................         79-24-3       100          310
Nitrogen dioxide..........................      10102-44-0      (C)5         (C)9
Nitrogen trifluoride......................       7783-54-2        10           29
Nitroglycerin.............................         55-63-0      (C)0.2       (C)2      X
Nitromethane..............................         75-52-5       100          250
1-Nitropropane............................        108-03-2        25           90
2-Nitropropane............................         79-46-9        25           90
N-Nitrosodimethylamine; see 1910.1016.
Nitrotoluene (all isomers)................  ..............         5           30      X
    o-isomer..............................         88-72-2
    m-isomer..............................         99-08-1
    p-isomer..............................         99-99-0
Nitrotrichloromethane; see Chloropicrin.
Octachloronaphthalene.....................       2234-13-1  ............        0.1    X
Octane....................................        111-65-9       500         2350
Oil mist, mineral.........................       8012-95-1  ............        5
Osmium tetroxide (as Os)..................      20816-12-0  ............        0.002
Oxalic acid...............................        144-62-7  ............        1
Oxygen difluoride.........................       7783-41-7         0.05         0.1
Ozone.....................................      10028-15-6         0.1          0.2

[[Page 15]]

 
Paraquat, respirable dust.................      4685-14-7;  ............        0.5    X
                                                1910-42-5;
                                                 2074-50-2
Parathion.................................         56-38-2  ............        0.1    X
Particulates not otherwise regulated
 (PNOR) \f\.
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
PCB; see Chlorodiphenyl (42% and 54%
 chlorine).
Pentaborane...............................      19624-22-7         0.005        0.01
Pentachloronaphthalene....................       1321-64-8  ............        0.5    X
Pentachlorophenol.........................         87-86-5  ............        0.5    X
Pentaerythritol...........................        115-77-5
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Pentane...................................        109-66-0      1000         2950
2-Pentanone (Methyl propyl ketone)........        107-87-9       200          700
Perchloroethylene (Tetrachloroethylene)...        127-18-4  ............    (\2\)
Perchloromethyl mercaptan.................        594-42-3         0.1          0.8
Perchloryl fluoride.......................       7616-94-6         3           13.5
Petroleum distillates (Naphtha) (Rubber     ..............       500         2000
 Solvent).
Phenol....................................        108-95-2         5           19      X
p-Phenylene diamine.......................        106-50-3  ............        0.1    X
Phenyl ether, vapor.......................        101-84-8         1            7
Phenyl ether-biphenyl mixture, vapor......  ..............         1            7
Phenylethylene; see Styrene.
Phenyl glycidyl ether (PGE)...............        122-60-1        10           60
Phenylhydrazine...........................        100-63-0         5           22      X
Phosdrin (Mevinphos)......................       7786-34-7  ............        0.1    X
Phosgene (Carbonyl chloride)..............         75-44-5         0.1          0.4
Phosphine.................................       7803-51-2         0.3          0.4
Phosphoric acid...........................       7664-38-2  ............        1
Phosphorus (yellow).......................       7723-14-0  ............        0.1
Phosphorus pentachloride..................      10026-13-8  ............        1
Phosphorus pentasulfide...................       1314-80-3  ............        1
Phosphorus trichloride....................       7719-12-2         0.5          3
Phthalic anhydride........................         85-44-9         2           12
Picloram..................................       1918-02-1
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Picric acid...............................         88-89-1  ............        0.1    X
Pindone (2-Pivalyl-1,3-indandione)........         83-26-1  ............        0.1
Plaster of Paris..........................      26499-65-0
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Platinum (as Pt)..........................       7440-06-4
    Metal.................................
    Soluble salts.........................  ..............  ............        0.002
Portland cement...........................      65997-15-1
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Propane...................................         74-98-6      1000         1800
beta-Propriolactone; see 1910.1013........         57-57-8
n-Propyl acetate..........................        109-60-4       200          840
n-Propyl alcohol..........................         71-23-8       200          500
n-Propyl nitrate..........................        627-13-4        25          110
Propylene dichloride......................         78-87-5        75          350
Propylene imine...........................         75-55-8         2            5      X
Propylene oxide...........................         75-56-9       100          240
Propyne; see Methyl acetylene.
Pyrethrum.................................       8003-34-7  ............        5
Pyridine..................................        110-86-1         5           15
Quinone...................................        106-51-4         0.1          0.4
RDX; see Cyclonite.
Rhodium (as Rh), metal fume and insoluble        7440-16-6  ............        0.1
 compounds.
Rhodium (as Rh), soluble compounds........       7440-16-6  ............        0.001
Ronnel....................................        299-84-3  ............       15
Rotenone..................................         83-79-4  ............        5
Rouge.....................................
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Selenium compounds (as Se)................       7782-49-2  ............        0.2
Selenium hexafluoride (as Se).............       7783-79-1         0.05         0.4

[[Page 16]]

 
Silica, amorphous, precipitated and gel...     112926-00-8  ............    (\3\)
Silica, amorphous, diatomaceous earth,          61790-53-2  ............    (\3\)
 containing less than 1% crystalline
 silica.
Silica, crystalline cristobalite,               14464-46-1  ............    (\3\)
 respirable dust.
Silica, crystalline quartz, respirable          14808-60-7  ............    (\3\)
 dust.
Silica, crystalline tripoli (as quartz),         1317-95-9  ............    (\3\)
 respirable dust.
Silica, crystalline tridymite, respirable       15468-32-3  ............    (\3\)
 dust.
Silica, fused, respirable dust............      60676-86-0  ............    (\3\)
Silicates (less than 1% crystalline
 silica).
    Mica (respirable dust)................      12001-26-2  ............    (\3\)
    Soapstone, total dust.................  ..............  ............    (\3\)
    Soapstone, respirable dust............  ..............  ............    (\3\)
    Talc (containing asbestos); use         ..............  ............    (\3\)
     asbestos limit; see 29 CFR 1910.1001.
    Talc (containing no asbestos),              14807-96-6  ............    (\3\)
     respirable dust.
 Tremolite, asbestiform; see 1910.1001.
Silicon...................................       7440-21-3
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Silicon carbide...........................        409-21-2
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Silver, metal and soluble compounds (as          7440-22-4  ............        0.01
 Ag).
Soapstone; see Silicates.
Sodium fluoroacetate......................         62-74-8  ............        0.05   X
Sodium hydroxide..........................       1310-73-2  ............        2
Starch....................................       9005-25-8
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Stibine...................................       7803-52-3         0.1          0.5
Stoddard solvent..........................       8052-41-3       500         2900
Strychnine................................         57-24-9  ............        0.15
Styrene...................................        100-42-5  ............    (\2\)
Sucrose...................................         57-50-1
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Sulfur dioxide............................       7446-09-5         5           13
Sulfur hexafluoride.......................       2551-62-4      1000         6000
Sulfuric acid.............................       7664-93-9  ............        1
Sulfur monochloride.......................      10025-67-9         1            6
Sulfur pentafluoride......................       5714-22-7         0.025        0.25
Sulfuryl fluoride.........................       2699-79-8         5           20
Systox; see Demeton.
2,4,5-T (2,4,5-trichlorophenoxyacetic              93-76-5  ............       10
 acid).
Talc; see Silicates.
Tantalum, metal and oxide dust............       7440-25-7  ............        5
TEDP (Sulfotep)...........................       3689-24-5  ............        0.2    X
Tellurium and compounds (as Te)...........      13494-80-9  ............        0.1
Tellurium hexafluoride (as Te)............       7783-80-4         0.02         0.2
Temephos..................................       3383-96-8
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
TEPP (Tetraethyl pyrophosphate)...........        107-49-3  ............        0.05   X
Terphenyls................................      26140-60-3      (C)1         (C)9
1,1,1,2-Tetrachloro-2,2-difluoroethane....         76-11-9       500         4170
1,1,2,2-Tetrachloro-1,2-difluoroethane....         76-12-0       500         4170
1,1,2,2-Tetrachloroethane.................         79-34-5         5           35      X
Tetrachloroethylene; see
 Perchloroethylene.
Tetrachloromethane; see Carbon
 tetrachloride.
Tetrachloronaphthalene....................       1335-88-2  ............        2      X
Tetraethyl lead (as Pb)...................         78-00-2  ............        0.075  X
Tetrahydrofuran...........................        109-99-9       200          590
Tetramethyl lead (as Pb)..................         75-74-1  ............        0.075  X
Tetramethyl succinonitrile................       3333-52-6         0.5          3      X
Tetranitromethane.........................        509-14-8         1            8
Tetryl (2,4,6-                                    479-45-8  ............        1.5    X
 Trinitrophenylmethylnitramine).
Thallium, soluble compounds (as Tl).......       7440-28-0  ............        0.1    X
4,4'-Thiobis (6-tert, Butyl-m-cresol).....         96-69-5
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Thiram....................................        137-26-8  ............        5
Tin, inorganic compounds (except oxides)         7440-31-5  ............        2
 (as Sn).

[[Page 17]]

 
Tin, organic compounds (as Sn)............       7440-31-5  ............        0.1
Titanium dioxide..........................      13463-67-7
    Total dust............................  ..............  ............       15
Toluene...................................        108-88-3  ............    (\2\)
Toluene-2,4-diisocyanate (TDI)............        584-84-9      (C)0.02      (C)0.14
o-Toluidine...............................         95-53-4         5           22      X
Toxaphene; see Chlorinated camphene.
Tremolite; see Silicates.
Tributyl phosphate........................        126-73-8  ............        5
1,1,1-Trichloroethane; see Methyl
 chloroform.
1,1,2-Trichloroethane.....................         79-00-5        10           45      X
Trichloroethylene.........................         79-01-6  ............    (\2\)
Trichloromethane; see Chloroform.
Trichloronaphthalene......................       1321-65-9  ............        5      X
1,2,3-Trichloropropane....................         96-18-4        50          300
1,1,2-Trichloro-1,2,2-trifluoroethane.....         76-13-1      1000         7600
Triethylamine.............................        121-44-8        25          100
Trifluorobromomethane.....................         75-63-8      1000         6100
2,4,6-Trinitrophenol; see Picric acid.
2,4,6-Trinitrophenylmethylnitramine; see
 Tetryl.
2,4,6-Trinitrotoluene (TNT)...............        118-96-7  ............        1.5    X
Triorthocresyl phosphate..................         78-30-8  ............        0.1
Triphenyl phosphate.......................        115-86-6  ............        3
Turpentine................................       8006-64-2       100          560
Uranium (as U)............................       7440-61-1
    Soluble compounds.....................  ..............  ............        0.05
    Insoluble compounds...................  ..............  ............        0.25
Vanadium..................................       1314-62-1
    Respirable dust (as V2 O5)............  ..............  ............     (C)0.5
    Fume (as V2 O5).......................  ..............  ............     (C)0.1
Vegetable oil mist........................
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Vinyl benzene; see Styrene.
Vinyl chloride; see 1910.1017.............         75-01-4
Vinyl cyanide; see Acrylonitrile.
Vinyl toluene.............................      25013-15-4       100          480
Warfarin..................................         81-81-2  ............        0.1
Xylenes (o-, m-, p-isomers)...............       1330-20-7       100          435
Xylidine..................................       1300-73-8         5           25      X
Yttrium...................................       7440-65-5  ............        1
Zinc chloride fume........................       7646-85-7  ............        1
Zinc oxide fume...........................       1314-13-2  ............        5
Zinc oxide................................       1314-13-2
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Zinc stearate.............................        557-05-1
    Total dust............................  ..............  ............       15
    Respirable fraction...................  ..............  ............        5
Zirconium compounds (as Zr)...............       7440-67-7  ............        5
----------------------------------------------------------------------------------------------------------------
\1\ The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be
  determined from breathing-zone air samples.
(a) Parts of vapor or gas per million parts of contaminated air by volume at 25 [deg]C and 760 torr.
(b) Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when
  listed with a ppm entry, it is approximate.
(c) The CAS number is for information only. Enforcement is based on the substance name. For an entry covering
  more than one metal compound, measured as the metal, the CAS number for the metal is given--not CAS numbers
  for the individual compounds.
(d) The final benzene standard in 1910.1028 applies to all occupational exposures to benzene except in some
  circumstances the distribution and sale of fuels, sealed containers and pipelines, coke production, oil and
  gas drilling and production, natural gas processing, and the percentage exclusion for liquid mixtures; for the
  excepted subsegments, the benzene limits in Table Z-2 apply. See 1910.1028 for specific circumstances.
(e) This 8-hour TWA applies to respirable dust as measured by a vertical elutriator cotton dust sampler or
  equivalent instrument. The time-weighted average applies to the cottom waste processing operations of waste
  recycling (sorting, blending, cleaning and willowing) and garnetting. See also 1910.1043 for cotton dust
  limits applicable to other sectors.
(f) All inert or nuisance dusts, whether mineral, inorganic, or organic, not listed specifically by substance
  name are covered by the Particulates Not Otherwise Regulated (PNOR) limit which is the same as the inert or
  nuisance dust limit of Table Z-3.
\2\ See Table Z-2.
\3\ See Table Z-3.
\4\ Varies with compound.
\5\ See Table Z-2 for the exposure limit for any operations or sectors where the exposure limit in Sec.
  1910.1026 is stayed or is otherwise not in effect.
\6\ If the exposure limit in Sec.  1910.1026 is stayed or is otherwise not in effect, the exposure limit is a
  ceiling of 0.1 mg/m\3\.


[[Page 18]]


                                                    Table Z-2
----------------------------------------------------------------------------------------------------------------
                                                                            Acceptable maximum peak above the
                                                                         acceptable ceiling concentration for an
           Substance                 8-hour time     Acceptable ceiling                 8-hr shift
                                  weighted average      concentration   ----------------------------------------
                                                                            Concentration      Maximum duration
----------------------------------------------------------------------------------------------------------------
Benzene \a\ (Z37.40-1969)......  10 ppm............  25 ppm............  50 ppm............  10 minutes.
Beryllium and beryllium          2 [micro]g/m\3\...  5 [micro]g/m\3\...  25 [micro]g/m\3\..  30 minutes.
 compounds (Z37.29-1970).
Cadmium fume \b\ (Z37.5-1970)..  0.1 mg/m\3\.......  0.3 mg/m\3\.......
Cadmium dust \b\ (Z37.5-1970)..  0.2 mg/m\3\.......  0.6 mg/m\3\.......
Carbon disulfide (Z37.3-1968)..  20 ppm............  30 ppm............  100 ppm...........  30 minutes.
Carbon tetrachloride (Z37.17-    10 ppm............  25 ppm............  200 ppm...........  5 min. in any 4
 1967).                                                                                       hrs.
Chromic acid and chromates       ..................  1 mg/10m\3\.......
 (Z37.7-1971) (as CrO3)\c\.
Ethylene dibromide (Z37.31-      20 ppm............  30 ppm............  50 ppm............  5 minutes.
 1970).
Ethylene dichloride (Z37.21-     50 ppm............  100 ppm...........  200 ppm...........  5 min. in any 3
 1969).                                                                                       hrs.
Fluoride as dust (Z37.28-1969).  2.5 mg/m\3\.......
Formaldehyde; see 1910.1048....
Hydrogen fluoride (Z37.28-1969)  3 ppm.............
Hydrogen sulfide (Z37.2-1966)..  ..................  20 ppm............  50 ppm............  10 mins. once, only
                                                                                              if no other meas.
                                                                                              exp. occurs.
Mercury (Z37.8-1971)...........  ..................  1 mg/10m\3\.......
Methyl chloride (Z37.18-1969)..  100 ppm...........  200 ppm...........  300 ppm...........  5 mins. in any 3
                                                                                              hrs.
Methylene Chloride: See Sec.
 1919.52..
Organo (alkyl) mercury (Z37.30-  0.01 mg/m\3\......  0.04 mg/m\3\......
 1969).
Styrene (Z37.15-1969)..........  100 ppm...........  200 ppm...........  600 ppm...........  5 mins. in any 3
                                                                                              hrs.
Tetrachloroethylene (Z37.22-     100 ppm...........  200 ppm...........  300 ppm...........  5 mins. in any 3
 1967).                                                                                       hrs.
Toluene (Z37.12-1967)..........  200 ppm...........  300 ppm...........  500 ppm...........  10 minutes.
Trichloroethylene (Z37.19-1967)  100 ppm...........  200 ppm...........  300 ppm...........  5 mins. in any 2
                                                                                              hrs.
----------------------------------------------------------------------------------------------------------------
\a\ This standard applies to the industry segments exempt from the 1 ppm 8-hour TWA and 5 ppm STEL of the
  benzene standard at 1910.1028.
\b\ This standard applies to any operations or sectors for which the Cadmium standard, 1910.1027, is stayed or
  otherwise not in effect.
\c\ This standard applies to any operations or sectors for which the exposure limit in the Chromium (VI)
  standard, Sec.  1910.1026, is stayed or is otherwise not in effect.


                        Table Z-3--Mineral Dusts
------------------------------------------------------------------------
                   Substance                     mppcf \a\     mg/m\3\
------------------------------------------------------------------------
Silica:
Crystalline
                                                  250 \b\     10 mg/m\3\
                                                                 \e\
    Quartz (Respirable).......................   ----------   ----------
                                                    %SiO2+5   % SiO2 + 2
 
                                                ...........   30 mg/m\3\
    Quartz (Total Dust).......................  ...........   ----------
                                                              % SiO2 + 2
 
  Cristobalite: Use \1/2\ the value calculated
   from the count or mass formulae for quartz
  Tridymite: Use \1/2\ the value calculated
   from the formulae for quartz
                                                ...........   80 mg/m\3\
Amorphous, including natural diatomaceous                20   ----------
 earth........................................                     %SiO2
 
Silicates (less than 1% crystalline silica):
  Mica........................................           20
  Soapstone...................................           20
  Talc (not containing asbestos)..............       20 \c\
  Talc (containing asbestos) Use asbestos
   limit......................................
  Tremolite, asbestiform (see 29 CFR
   1910.1001).................................
  Portland cement.............................           50
 
Graphite (Natural)............................           15
 
Coal Dust:
 
  Respirable fraction less than 5% SiO2.......  ...........     2.4 mg/
                                                               m\3\ \e\

[[Page 19]]

 
 
                                                ...........   10 mg/m\3\
                                                                 \e\
  Respirable fraction greater than 5% SiO2....  ...........   ----------
                                                                 %SiO2+2
 
Inert or Nuisance Dust: \d\
  Respirable fraction.........................           15    5 mg/m\3\
  Total dust..................................           50   15 mg/m\3\
------------------------------------------------------------------------
Note--Conversion factors - mppcf x 35.3 = million particles per cubic
  meter = particles per c.c.
 
\a\ Millions of particles per cubic foot of air, based on impinger
  samples counted by light-field techniques.
\b\ The percentage of crystalline silica in the formula is the amount
  determined from airborne samples, except in those instances in which
  other methods have been shown to be applicable.
\c\ Containing less than 1% quartz; if 1% quartz or more, use quartz
  limit.
\d\ All inert or nuisance dusts, whether mineral, inorganic, or organic,
  not listed specifically by substance name are covered by this limit,
  which is the same as the Particulates Not Otherwise Regulated (PNOR)
  limit in Table Z-1.
\e\ Both concentration and percent quartz for the application of this
  limit are to be determined from the fraction passing a size-selector
  with the following characteristics:


------------------------------------------------------------------------
                                                        Percent passing
      Aerodynamic diameter (unit density sphere)            selector
------------------------------------------------------------------------
2....................................................                 90
2.5..................................................                 75
3.5..................................................                 50
5.0..................................................                 25
10...................................................                  0
------------------------------------------------------------------------
The measurements under this note refer to the use of an AEC (now NRC)
  instrument. The respirable fraction of coal dust is determined with an
  MRE; the figure corresponding to that of 2.4 mg/m\3\ in the table for
  coal dust is 4.5 mg/m\3K\.


[58 FR 35340, June 30. 1993; 58 FR 40191, July 27, 1993, as amended at 
61 FR 56831, Nov. 4, 1996; 62 FR 1600, Jan. 10, 1997; 62 FR 42018, Aug. 
4, 1997; 71 FR 10373, Feb. 28, 2006; 71 FR 16673, Apr. 3, 2006; 71 FR 
36008, June 23, 2006]



Sec. 1910.1001  Asbestos.

    (a) Scope and application. (1) This section applies to all 
occupational exposures to asbestos in all industries covered by the 
Occupational Safety and Health Act, except as provided in paragraph 
(a)(2) and (3) of this section.
    (2) This section does not apply to construction work as defined in 
29 CFR 1910.12(b). (Exposure to asbestos in construction work is covered 
by 29 CFR 1926.1101).
    (3) This section does not apply to ship repairing, shipbuilding and 
shipbreaking employments and related employments as defined in 29 CFR 
1915.4. (Exposure to asbestos in these employments is covered by 29 CFR 
1915.1001).
    (b) Definitions. Asbestos includes chrysotile, amosite, crocidolite, 
tremolite asbestos, anthophyllite asbestos, actinolite asbestos, and any 
of these minerals that have been chemically treated and/or altered.
    Asbestos-containing material (ACM) means any material containing 
more than 1% asbestos.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Authorized person means any person authorized by the employer and 
required by work duties to be present in regulated areas.
    Building/facility owner is the legal entity, including a lessee, 
which exercises control over management and record keeping functions 
relating to a building and/or facility in which activities covered by 
this standard take place.
    Certified industrial hygienist (CIH) means one certified in the 
practice of industrial hygiene by the American Board of Industrial 
Hygiene.
    Director means the Director of the National Institute for 
Occupational Safety and Health, U.S. Department of Health and Human 
Services, or designee.
    Employee exposure means that exposure to airborne asbestos that 
would occur if the employee were not using respiratory protective 
equipment.
    Fiber means a particulate form of asbestos 5 micrometers or 
longer,with a

[[Page 20]]

length-to-diameter ratio of at least 3 to 1.
    High-efficiency particulate air (HEPA) filter means a filter capable 
of trapping and retaining at least 99.97 percent of 0.3 micrometer 
diameter mono-disperse particles.
    Homogeneous area means an area of surfacing material or thermal 
system insulation that is uniform in color and texture.
    Industrial hygienist means a professional qualified by education, 
training, and experience to anticipate, recognize, evaluate and develop 
controls for occupational health hazards.
    PACM means ``presumed asbestos containing material.''
    Presumed asbestos containing material means thermal system 
insulation and surfacing material found in buildings constructed no 
later than 1980. The designation of a material as ``PACM'' may be 
rebutted pursuant to paragraph (j)(8) of this section.
    Regulated area means an area established by the employer to 
demarcate areas where airborne concentrations of asbestos exceed, or 
there is a reasonable possibility they may exceed, the permissible 
exposure limits.
    Surfacing ACM means surfacing material which contains more than 1% 
asbestos.
    Surfacing material means material that is sprayed, troweled-on or 
otherwise applied to surfaces (such as acoustical plaster on ceilings 
and fireproofing materials on structural members, or other materials on 
surfaces for acoustical, fireproofing, and other purposes).
    Thermal System Insulation (TSI) means ACM applied to pipes, 
fittings, boilers, breeching, tanks, ducts or other structural 
components to prevent heat loss or gain.
    Thermal System Insulation ACM means thermal system insulation which 
contains more than 1% asbestos.
    (c) Permissible exposure limit (PELS)--(1) Time-weighted average 
limit (TWA). The employer shall ensure that no employee is exposed to an 
airborne concentration of asbestos in excess of 0.1 fiber per cubic 
centimeter of air as an eight (8)-hour time-weighted average (TWA) as 
determined by the method prescribed in Appendix A to this section, or by 
an equivalent method.
    (2) Excursion limit. The employer shall ensure that no employee is 
exposed to an airborne concentration of asbestos in excess of 1.0 fiber 
per cubic centimeter of air (1 f/cc) as averaged over a sampling period 
of thirty (30) minutes as determined by the method prescribed in 
Appendix A to this section, or by an equivalent method.
    (d) Exposure monitoring--(1) General. (i) Determinations of employee 
exposure shall be made from breathing zone air samples that are 
representative of the 8-hour TWA and 30-minute short-term exposures of 
each employee.
    (ii) Representative 8-hour TWA employee exposures shall be 
determined on the basis of one or more samples representing full-shift 
exposures for each shift for each employee in each job classification in 
each work area. Representative 30-minute short-term employee exposures 
shall be determined on the basis of one or more samples representing 30 
minute exposures associated with operations that are most likely to 
produce exposures above the excursion limit for each shift for each job 
classification in each work area.
    (2) Initial monitoring. (i) Each employer who has a workplace or 
work operation covered by this standard, except as provided for in 
paragraphs (d)(2)(ii) and (d)(2)(iii) of this section, shall perform 
initial monitoring of employees who are, or may reasonably be expected 
to be exposed to airborne concentrations at or above the TWA permissible 
exposure limit and/or excursion limit.
    (ii) Where the employer has monitored after March 31, 1992, for the 
TWA permissible exposure limit and/or the excursion limit, and the 
monitoring satisfies all other requirements of this section, the 
employer may rely on such earlier monitoring results to satisfy the 
requirements of paragraph (d)(2)(i) of this section.
    (iii) Where the employer has relied upon objective data that 
demonstrate that asbestos is not capable of being released in airborne 
concentrations at or above the TWA permissible exposure limit and/or 
excursion limit under the expected conditions of processing, use,

[[Page 21]]

or handling, then no initial monitoring is required.
    (3) Monitoring frequency (periodic monitoring) and patterns. After 
the initial determinations required by paragraph (d)(2)(i) of this 
section, samples shall be of such frequency and pattern as to represent 
with reasonable accuracy the levels of exposure of the employees. In no 
case shall sampling be at intervals greater than six months for 
employees whose exposures may reasonably be foreseen to exceed the TWA 
permissible exposure limit and/or excursion limit.
    (4) Changes in monitoring frequency. If either the initial or the 
periodic monitoring required by paragraphs (d)(2) and (d)(3) of this 
section statistically indicates that employee exposures are below the 
TWA permissible exposure limit and/or excursion limit, the employer may 
discontinue the monitoring for those employees whose exposures are 
represented by such monitoring.
    (5) Additional monitoring. Notwithstanding the provisions of 
paragraphs (d)(2)(ii) and (d)(4) of this section, the employer shall 
institute the exposure monitoring required under paragraphs (d)(2)(i) 
and (d)(3) of this section whenever there has been a change in the 
production, process, control equipment, personnel or work practices that 
may result in new or additional exposures above the TWA permissible 
exposure limit and/or excursion limit or when the employer has any 
reason to suspect that a change may result in new or additional 
exposures above the PEL and/or excursion limit.
    (6) Method of monitoring. (i) All samples taken to satisfy the 
monitoring requirements of paragraph (d) of this section shall be 
personal samples collected following the procedures specified in 
Appendix A.
    (ii) All samples taken to satisfy the monitoring requirements of 
paragraph (d) of this section shall be evaluated using the OSHA 
Reference Method (ORM) specified in Appendix A of this section, or an 
equivalent counting method.
    (iii) If an equivalent method to the ORM is used, the employer shall 
ensure that the method meets the following criteria:
    (A) Replicate exposure data used to establish equivalency are 
collected in side-by-side field and laboratory comparisons; and
    (B) The comparison indicates that 90% of the samples collected in 
the range 0.5 to 2.0 times the permissible limit have an accuracy range 
of plus or minus 25 percent of the ORM results at a 95% confidence level 
as demonstrated by a statistically valid protocol; and
    (C) The equivalent method is documented and the results of the 
comparison testing are maintained.
    (iv) To satisfy the monitoring requirements of paragraph (d) of this 
section, employers must use the results of monitoring analysis performed 
by laboratories which have instituted quality assurance programs that 
include the elements as prescribed in Appendix A of this section.
    (7) Employee notification of monitoring results. (i) The employer 
must, within 15 working days after the receipt of the results of any 
monitoring performed under this sections, notify each affected employee 
of these results either individually in writing or by posting the 
results in an appropriate location that is accessible to affected 
employees.
    (ii) The written notification required by paragraph (d)(7)(i) of 
this section shall contain the corrective action being taken by the 
employer to reduce employee exposure to or below the TWA and/or 
excursion limit, wherever monitoring results indicated that the TWA and/
or excursion limit had been exceeded.
    (e) Regulated Areas--(1) Establishment. The employer shall establish 
regulated areas wherever airborne concentrations of asbestos and/or PACM 
are in excess of the TWA and/or excursion limit prescribed in paragraph 
(c) of this section.
    (2) Demarcation. Regulated areas shall be demarcated from the rest 
of the workplace in any manner that minimizes the number of persons who 
will be exposed to asbestos.
    (3) Access. Access to regulated areas shall be limited to authorized 
persons or to persons authorized by the Act or regulations issued 
pursuant thereto.
    (4) Provision of respirators. Each person entering a regulated area 
shall be

[[Page 22]]

supplied with and required to use a respirator, selected in accordance 
with paragraph (g)(2) of this section.
    (5) Prohibited activities. The employer shall ensure that employees 
do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in the 
regulated areas.
    (f) Methods of compliance--(1) Engineering controls and work 
practices. (i) The employer shall institute engineering controls and 
work practices to reduce and maintain employee exposure to or below the 
TWA and/or excursion limit prescribed in paragraph (c) of this section, 
except to the extent that such controls are not feasible.
    (ii) Wherever the feasible engineering controls and work practices 
that can be instituted are not sufficient to reduce employee exposure to 
or below the TWA and/or excursion limit prescribed in paragraph (c) of 
this section, the employer shall use them to reduce employee exposure to 
the lowest levels achievable by these controls and shall supplement them 
by the use of respiratory protection that complies with the requirements 
of paragraph (g) of this section.
    (iii) For the following operations, wherever feasible engineering 
controls and work practices that can be instituted are not sufficient to 
reduce the employee exposure to or below the TWA and/or excursion limit 
prescribed in paragraph (c) of this section, the employer shall use them 
to reduce employee exposure to or below 0.5 fiber per cubic centimeter 
of air (as an eight-hour time-weighted average) or 2.5 fibers/cc for 30 
minutes (short-term exposure) and shall supplement them by the use of 
any combination of respiratory protection that complies with the 
requirements of paragraph (g) of this section, work practices and 
feasible engineering controls that will reduce employee exposure to or 
below the TWA and to or below the excursion limit permissible prescribed 
in paragraph (c) of this section: Coupling cutoff in primary asbestos 
cement pipe manufacturing; sanding in primary and secondary asbestos 
cement sheet manufacturing; grinding in primary and secondary friction 
product manufacturing; carding and spinning in dry textile processes; 
and grinding and sanding in primary plastics manufacturing.
    (iv) Local exhaust ventilation. Local exhaust ventilation and dust 
collection systems shall be designed, constructed, installed, and 
maintained in accordance with good practices such as those found in the 
American National Standard Fundamentals Governing the Design and 
Operation of Local Exhaust Systems, ANSI Z9.2-1979.
    (v) Particular tools. All hand-operated and power-operated tools 
which would produce or release fibers of asbestos, such as, but not 
limited to, saws, scorers, abrasive wheels, and drills, shall be 
provided with local exhaust ventilation systems which comply with 
paragraph (f)(1)(iv) of this section.
    (vi) Wet methods. Insofar as practicable, asbestos shall be handled, 
mixed, applied, removed, cut, scored, or otherwise worked in a wet state 
sufficient to prevent the emission of airborne fibers so as to expose 
employees to levels in excess of the TWA and/or excursion limit, 
prescribed in paragraph (c) of this section, unless the usefulness of 
the product would be diminished thereby.
    (vii) [Reserved]
    (viii) Particular products and operations. No asbestos cement, 
mortar, coating, grout, plaster, or similar material containing 
asbestos, shall be removed from bags, cartons, or other containers in 
which they are shipped, without being either wetted, or enclosed, or 
ventilated so as to prevent effectively the release of airborne fibers.
    (ix) Compressed air. Compressed air shall not be used to remove 
asbestos or materials containing asbestos unless the compressed air is 
used in conjunction with a ventilation system which effectively captures 
the dust cloud created by the compressed air.
    (x) Flooring. Sanding of asbestos-containing flooring material is 
prohibited.
    (2) Compliance program. (i) Where the TWA and/or excursion limit is 
exceeded, the employer shall establish and implement a written program 
to reduce employee exposure to or below the TWA and to or below the 
excursion limit by means of engineering and work practice controls as 
required by paragraph (f)(1) of this section, and by the use of 
respiratory protection where

[[Page 23]]

required or permitted under this section.
    (ii) Such programs shall be reviewed and updated as necessary to 
reflect significant changes in the status of the employer's compliance 
program.
    (iii) Written programs shall be submitted upon request for 
examination and copying to the Assistant Secretary, the Director, 
affected employees and designated employee representatives.
    (iv) The employer shall not use employee rotation as a means of 
compliance with the TWA and/or excursion limit.
    (3) Specific compliance methods for brake and clutch repair:
    (i) Engineering controls and work practices for brake and clutch 
repair and service. During automotive brake and clutch inspection, 
disassembly, repair and assembly operations, the employer shall 
institute engineering controls and work practices to reduce employee 
exposure to materials containing asbestos using a negative pressure 
enclosure/HEPA vacuum system method or low pressure/wet cleaning method, 
which meets the detailed requirements set out in Appendix F to this 
section. The employer may also comply using an equivalent method which 
follows written procedures which the employer demonstrates can achieve 
results equivalent to Method A in Appendix F to this section. For 
facilities in which no more than 5 pair of brakes or 5 clutches are 
inspected, disassembled, repaired, or assembled per week, the method set 
forth in paragraph [D] of Appendix F to this section may be used.
    (ii) The employer may also comply by using an equivalent method 
which follows written procedures, which the employer demonstrates can 
achieve equivalent exposure reductions as do the two ``preferred 
methods.'' Such demonstration must include monitoring data conducted 
under workplace conditions closely resembling the process, type of 
asbestos containing materials, control method, work practices and 
environmental conditions which the equivalent method will be used, or 
objective data, which document that under all reasonably foreseeable 
conditions of brake and clutch repair applications, the method results 
in exposures which are equivalent to the methods set out in Appendix F 
to this section.
    (g) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer must provide each 
employee an appropriate respirator that complies with the requirements 
of this paragraph. Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities, for 
which engineering and work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the TWA and/or excursion limit.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 134 (b) through 
(d) (except (d)(1)(iii)), and (f) through (m), which covers each 
employee required by this section to use a respirator.
    (ii) Employers must provide an employee with a tight-fitting, 
powered air-purifying respirator (PAPR) instead of a negative pressure 
respirator selected according to paragraph (g)(3) of this standard when 
the employee chooses to use a PAPR and it provides adequate protection 
to the employee.
    (iii) No employee must be assigned to tasks requiring the use of 
respirators if, based on their most recent medical examination, the 
examining physician determines that the employee will be unable to 
function normally using a respirator, or that the safety or health of 
the employee or other employees will be impaired by the use of a 
respirator. Such employees must be assigned to another job or given the 
opportunity to transfer to a different position, the duties of which 
they can perform. If such a transfer position is available, the position 
must be with the same employer, in the same geographical area, and with 
the same seniority, status, and rate of pay the employee had just prior 
to such transfer.

[[Page 24]]

    (3) Respirator selection. Employers must:
    (i) Select, and provide to employees, the appropriate respirators 
specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134; however, 
employers must not select or use filtering facepiece respirators for 
protection against asbestos fibers.
    (ii) Provide HEPA filters for powered and non-powered air-purifying 
respirators.
    (h) Protective work clothing and equipment--(1) Provision and use. 
If an employee is exposed to asbestos above the TWA and/or excursion 
limit, or where the possibility of eye irritation exists, the employer 
shall provide at no cost to the employee and ensure that the employee 
uses appropriate protective work clothing and equipment such as, but not 
limited to:
    (i) Coveralls or similar full-body work clothing;
    (ii) Gloves, head coverings, and foot coverings; and
    (iii) Face shields, vented goggles, or other appropriate protective 
equipment which complies with 1910.133 of this Part.
    (2) Removal and storage. (i) The employer shall ensure that 
employees remove work clothing contaminated with asbestos only in change 
rooms provided in accordance with paragraph (i)(1) of this section.
    (ii) The employer shall ensure that no employee takes contaminated 
work clothing out of the change room, except those employees authorized 
to do so for the purpose of laundering, maintenance, or disposal.
    (iii) Contaminated work clothing shall be placed and stored in 
closed containers which prevent dispersion of the asbestos outside the 
container.
    (iv) Containers of contaminated protective devices or work clothing 
which are to be taken out of change rooms or the workplace for cleaning, 
maintenance or disposal, shall bear labels in accordance with paragraph 
(j)(4) of this section.
    (3) Cleaning and replacement. (i) The employer shall clean, launder, 
repair, or replace protective clothing and equipment required by this 
paragraph to maintain their effectiveness. The employer shall provide 
clean protective clothing and equipment at least weekly to each affected 
employee.
    (ii) The employer shall prohibit the removal of asbestos from 
protective clothing and equipment by blowing or shaking. (iii) 
Laundering of contaminated clothing shall be done so as to prevent the 
release of airborne fibers of asbestos in excess of the permissible 
exposure limits prescribed in paragraph (c) of this section.
    (iv) Any employer who gives contaminated clothing to another person 
for laundering shall inform such person of the requirement in paragraph 
(h)(3)(iii) of this section to effectively prevent the release of 
airborne fibers of asbestos in excess of the permissible exposure 
limits.
    (v) The employer shall inform any person who launders or cleans 
protective clothing or equipment contaminated with asbestos of the 
potentially harmful effects of exposure to asbestos.
    (vi) Contaminated clothing shall be transported in sealed 
impermeable bags, or other closed, impermeable containers, and labeled 
in accordance with paragraph (j) of this section.
    (i) Hygiene facilities and practices--(1) Change rooms. (i) The 
employer shall provide clean change rooms for employees who work in 
areas where their airborne exposure to asbestos is above the TWA and/or 
excursion limit.
    (ii) The employer shall ensure that change rooms are in accordance 
with 1910.141(e) of this part, and are equipped with two separate 
lockers or storage facilities, so separated as to prevent contamination 
of the employee's street clothes from his protective work clothing and 
equipment.
    (2) Showers. (i) The employer shall ensure that employees who work 
in areas where their airborne exposure is above the TWA and/or excursion 
limit, shower at the end of the work shift.
    (ii) The employer shall provide shower facilities which comply with 
1910.141(d)(3) of this part.
    (iii) The employer shall ensure that employees who are required to 
shower pursuant to paragraph (i)(2)(i) of this section do not leave the 
workplace wearing any clothing or equipment worn during the work shift.
    (3) Lunchrooms. (i) The employer shall provide lunchroom facilities 
for

[[Page 25]]

employees who work in areas where their airborne exposure is above the 
TWA and/or excursion limit.
    (ii) The employer shall ensure that lunchroom facilities have a 
positive pressure, filtered air supply, and are readily accessible to 
employees.
    (iii) The employer shall ensure that employees who work in areas 
where their airborne exposure is above the PEL and/or excursion limit 
wash their hands and faces prior to eating, drinking or smoking.
    (iv) The employer shall ensure that employees do not enter lunchroom 
facilities with protective work clothing or equipment unless surface 
asbestos fibers have been removed from the clothing or equipment by 
vacuuming or other method that removes dust without causing the asbestos 
to become airborne.
    (4) Smoking in work areas. The employer shall ensure that employees 
do not smoke in work areas where they are occupationally exposed to 
asbestos because of activities in that work area.
    (j) Communication of hazards to employees--Introduction. This 
section applies to the communication of information concerning asbestos 
hazards in general industry to facilitate compliance with this standard. 
Asbestos exposure in general industry occurs in a wide variety of 
industrial and commercial settings. Employees who manufacture asbestos-
containing products may be exposed to asbestos fibers. Employees who 
repair and replace automotive brakes and clutches may be exposed to 
asbestos fibers. In addition, employees engaged in housekeeping 
activities in industrial facilities with asbestos product manufacturing 
operations, and in public and commercial buildings with installed 
asbestos containing materials may be exposed to asbestos fibers. Most of 
these workers are covered by this general industry standard, with the 
exception of state or local governmental employees in non-state plan 
states. It should be noted that employees who perform housekeeping 
activities during and after construction activities are covered by the 
asbestos construction standard, 29 CFR 1926.1101, formerly 1926.58. 
However, housekeeping employees, regardless of industry designation, 
should know whether building components they maintain may expose them to 
asbestos. The same hazard communication provisions will protect 
employees who perform housekeeping operations in all three asbestos 
standards; general industry, construction, and shipyard employment. As 
noted in the construction standard, building owners are often the only 
and/or best source of information concerning the presence of previously 
installed asbestos containing building materials. Therefore they, along 
with employers of potentially exposed employees, are assigned specific 
information conveying and retention duties under this section.
    (1) Installed Asbestos Containing Material. Employers and building 
owners are required to treat installed TSI and sprayed on and troweled-
on surfacing materials as ACM in buildings constructed no later than 
1980 for purposes of this standard. These materials are designated 
``presumed ACM or PACM'', and are defined in paragraph (b) of this 
section. Asphalt and vinyl flooring material installed no later than 
1980 also must be treated as asbestos-containing. The employer or 
building owner may demonstrate that PACM and flooring material do not 
contain asbestos by complying with paragraph (j)(8)(iii) of this 
section.
    (2) Duties of employers and building and facility owners. (i) 
Building and facility owners shall determine the presence, location, and 
quantity of ACM and/or PACM at the work site. Employers and building and 
facility owners shall exercise due diligence in complying with these 
requirements to inform employers and employees about the presence and 
location of ACM and PACM.
    (ii) Building and facility owners shall maintain records of all 
information required to be provided pursuant to this section and/or 
otherwise known to the building owner concerning the presence, location 
and quantity of ACM and PACM in the building/facility. Such records 
shall be kept for the duration of ownership and shall be transferred to 
successive owners.
    (iii) Building and facility owners shall inform employers of 
employees, and employers shall inform employees

[[Page 26]]

who will perform housekeeping activities in areas which contain ACM and/
or PACM of the presence and location of ACM and/or PACM in such areas 
which may be contacted during such activities.
    (3) Warning signs--(i) Posting. Warning signs shall be provided and 
displayed at each regulated area. In addition, warning signs shall be 
posted at all approaches to regulated areas so that an employee may read 
the signs and take necessary protective steps before entering the area.
    (ii) Sign specifications. (A) The warning signs required by 
paragraph (j)(3) of this section shall bear the following information:

                                 DANGER

                                ASBESTOS

                     CANCER AND LUNG DISEASE HAZARD

                        AUTHORIZED PERSONNEL ONLY

    (B) In addition, where the use of respirators and protective 
clothing is required in the regulated area under this section, the 
warning signs shall include the following:

                   RESPIRATORS AND PROTECTIVE CLOTHING

                        ARE REQUIRED IN THIS AREA

    (iii) [Reserved]
    (iv) The employer shall ensure that employees working in and 
contiguous to regulated areas comprehend the warning signs required to 
be posted by paragraph (j)(3)(i) of this section. Means to ensure 
employee comprehension may include the use of foreign languages, 
pictographs and graphics.
    (v) At the entrance to mechanical rooms/areas in which employees 
reasonably can be expected to enter and which contain ACM and/or PACM, 
the building owner shall post signs which identify the material which is 
present, its location, and appropriate work practices which, if 
followed, will ensure that ACM and/or PACM will not be disturbed. The 
employer shall ensure, to the extent feasible, that employees who come 
in contact with these signs can comprehend them. Means to ensure 
employee comprehension may include the use of foreign languages, 
pictographs, graphics, and awareness training.
    (4) Warning labels--(i) Labeling. Warning labels shall be affixed to 
all raw materials, mixtures, scrap, waste, debris, and other products 
containing asbestos fibers, or to their containers. When a building 
owner or employer identifies previously installed ACM and/or PACM, 
labels or signs shall be affixed or posted so that employees will be 
notified of what materials contain ACM and/or PACM. The employer shall 
attach such labels in areas where they will clearly be noticed by 
employees who are likely to be exposed, such as at the entrance to 
mechanical room/areas. Signs required by paragraph (j)(3) of this 
section may be posted in lieu of labels so long as they contain 
information required for labelling.
    (ii) Label specifications. The labels shall comply with the 
requirements of 29 CFR 1910.1200(f) of OSHA's Hazard Communication 
standard, and shall include the following information:

                                 DANGER

                        CONTAINS ASBESTOS FIBERS

                           AVOID CREATING DUST

                     CANCER AND LUNG DISEASE HAZARD

    (5) Material safety data sheets. Employers who are manufacturers or 
importers of asbestos or asbestos products shall comply with the 
requirements regarding development of material safety data sheets as 
specified in 29 CFR 1910.1200(g) of OSHA's Hazard Communication 
standard, except as provided by paragraph (j)(6) of this section.
    (6) The provisions for labels required by paragraph (j)(4) of this 
section or for material safety data sheets required by paragraph (j)(5) 
of this section do not apply where:
    (i) Asbestos fibers have been modified by a bonding agent, coating, 
binder, or other material provided that the manufacturer can demonstrate 
that during any reasonably foreseeable use, handling, storage, disposal, 
processing, or transportation, no airborne concentrations of fibers of 
asbestos in excess of the TWA permissible exposure level and/or 
excursion limit will be released or
    (ii) Asbestos is present in a product in concentrations less than 
1.0%.
    (7) Employee information and training. (i) The employer shall train 
each employee who is exposed to airborne concentrations of asbestos at 
or above the

[[Page 27]]

PEL and/or excursion limit in accordance with the requirements of this 
section. The employer shall institute a training program and ensure 
employee participation in the program.
    (ii) Training shall be provided prior to or at the time of initial 
assignment and at least annually thereafter.
    (iii) The training program shall be conducted in a manner which the 
employee is able to understand. The employer shall ensure that each 
employee is informed of the following:
    (A) The health effects associated with asbestos exposure;
    (B) The relationship between smoking and exposure to asbestos 
producing lung cancer:
    (C) The quantity, location, manner of use, release, and storage of 
asbestos, and the specific nature of operations which could result in 
exposure to asbestos;
    (D) The engineering controls and work practices associated with the 
employee's job assignment;
    (E) The specific procedures implemented to protect employees from 
exposure to asbestos, such as appropriate work practices, emergency and 
clean-up procedures, and personal protective equipment to be used;
    (F) The purpose, proper use, and limitations of respirators and 
protective clothing, if appropriate;
    (G) The purpose and a description of the medical surveillance 
program required by paragraph (l) of this section;
    (H) The content of this standard, including appendices.
    (I) The names, addresses and phone numbers of public health 
organizations which provide information, materials, and/or conduct 
programs concerning smoking cessation. The employer may distribute the 
list of such organizations contained in Appendix I to this section, to 
comply with this requirement.
    (J) The requirements for posting signs and affixing labels and the 
meaning of the required legends for such signs and labels.
    (iv) The employer shall also provide, at no cost to employees who 
perform housekeeping operations in an area which contains ACM or PACM, 
an asbestos awareness training course, which shall at a minimum contain 
the following elements: health effects of asbestos, locations of ACM and 
PACM in the building/facility, recognition of ACM and PACM damage and 
deterioration, requirements in this standard relating to housekeeping, 
and proper response to fiber release episodes, to all employees who 
perform housekeeping work in areas where ACM and/or PACM is present. 
Each such employee shall be so trained at least once a year.
    (v) Access to information and training materials.
    (A) The employer shall make a copy of this standard and its 
appendices readily available without cost to all affected employees.
    (B) The employer shall provide, upon request, all materials relating 
to the employee information and training program to the Assistant 
Secretary and the training program to the Assistant Secretary and the 
Director.
    (C) The employer shall inform all employees concerning the 
availability of self-help smoking cessation program material. Upon 
employee request, the employer shall distribute such material, 
consisting of NIH Publication No. 89-1647, or equivalent self-help 
material, which is approved or published by a public health organization 
listed in Appendix I to this section.
    (8) Criteria to rebut the designation of installed material as PACM. 
(i) At any time, an employer and/or building owner may demonstrate, for 
purposes of this standard, that PACM does not contain asbestos. Building 
owners and/or employers are not required to communicate information 
about the presence of building material for which such a demonstration 
pursuant to the requirements of paragraph (j)(8)(ii) of this section has 
been made. However, in all such cases, the information, data and 
analysis supporting the determination that PACM does not contain 
asbestos, shall be retained pursuant to paragraph (m) of this section.
    (ii) An employer or owner may demonstrate that PACM does not contain 
asbestos by the following:
    (A) Having a completed inspection conducted pursuant to the 
requirements of AHERA (40 CFR 763, Subpart E) which demonstrates that no 
ACM is present in the material; or

[[Page 28]]

    (B) Performing tests of the material containing PACM which 
demonstrate that no ACM is present in the material. Such tests shall 
include analysis of bulk samples collected in the manner described in 40 
CFR 763.86. The tests, evaluation and sample collection shall be 
conducted by an accredited inspector or by a CIH. Analysis of samples 
shall be performed by persons or laboratories with proficiency 
demonstrated by current successful participation in a nationally 
recognized testing program such as the National Voluntary Laboratory 
Accreditation Program (NVLAP) or the National Institute for Standards 
and Technology (NIST) or the Round Robin for bulk samples administered 
by the American Industrial Hygiene Association (AIHA) or an equivalent 
nationally-recognized round robin testing program.
    (iii) The employer and/or building owner may demonstrate that 
flooring material including associated mastic and backing does not 
contain asbestos, by a determination of an industrial hygienist based 
upon recognized analytical techniques showing that the material is not 
ACM.
    (k) Housekeeping. (1) All surfaces shall be maintained as free as 
practicable of ACM waste and debris and accompanying dust.
    (2) All spills and sudden releases of material containing asbestos 
shall be cleaned up as soon as possible.
    (3) Surfaces contaminated with asbestos may not be cleaned by the 
use of compressed air.
    (4) Vacuuming. HEPA-filtered vacuuming equipment shall be used for 
vacuuming asbestos containing waste and debris. The equipment shall be 
used and emptied in a manner which minimizes the reentry of asbestos 
into the workplace.
    (5) Shoveling, dry sweeping and dry clean-up of asbestos may be used 
only where vacuuming and/or wet cleaning are not feasible.
    (6) Waste disposal. Waste, scrap, debris, bags, containers, 
equipment, and clothing contaminated with asbestos consigned for 
disposal, shall be collected, recycled and disposed of in sealed 
impermeable bags, or other closed, impermeable containers.
    (7) Care of asbestos-containing flooring material.
    (i) Sanding of asbestos-containing floor material is prohibited.
    (ii) Stripping of finishes shall be conducted using low abrasion 
pads at speeds lower than 300 rpm and wet methods.
    (iii) Burnishing or dry buffing may be performed only on asbestos-
containing flooring which has sufficient finish so that the pad cannot 
contact the asbestos-containing material.
    (8) Waste and debris and accompanying dust in an area containing 
accessible ACM and/or PACM or visibly deteriorated ACM, shall not be 
dusted or swept dry, or vacuumed without using a HEPA filter.
    (l) Medical surveillance--(1) General--(i) Employees covered. The 
employer shall institute a medical surveillance program for all 
employees who are or will be exposed to airborne concentrations of 
fibers of asbestos at or above the TWA and/or excursion limit.
    (ii) Examination by a physician. (A) The employer shall ensure that 
all medical examinations and procedures are performed by or under the 
supervision of a licensed physician, and shall be provided without cost 
to the employee and at a reasonable time and place.
    (B) Persons other than licensed physicians, who administer the 
pulmonary function testing required by this section, shall complete a 
training course in spirometry sponsored by an appropriate academic or 
professional institution.
    (2) Pre-placement examinations. (i) Before an employee is assigned 
to an occupation exposed to airborne concentrations of asbestos fibers 
at or above the TWA and/or excursion limit, a pre-placement medical 
examination shall be provided or made available by the employer.
    (ii) Such examination shall include, as a minimum, a medical and 
work history; a complete physical examination of all systems with 
emphasis on the respiratory system, the cardiovascular system and 
digestive tract; completion of the respiratory disease standardized 
questionnaire in Appendix D to this section, Part 1; a chest 
roentgenogram

[[Page 29]]

(posterior-anterior 14x17 inches); pulmonary function tests to include 
forced vital capacity (FVC) and forced expiratory volume at 1 second 
(FEV(1.0)); and any additional tests deemed appropriate by the examining 
physician. Interpretation and classification of chest roentgenogram 
shall be conducted in accordance with Appendix E to this section.
    (3) Periodic examinations. (i) Periodic medical examinations shall 
be made available annually.
    (ii) The scope of the medical examination shall be in conformance 
with the protocol established in paragraph (l)(2)(ii) of this section, 
except that the frequency of chest roentgenogram shall be conducted in 
accordance with Table 1, and the abbreviated standardized questionnaire 
contained in, Part 2 of Appendix D to this section shall be administered 
to the employee.

                                    Table 1--Frequency of Chest Roentgenogram
----------------------------------------------------------------------------------------------------------------
                                                                 Age of employee
   Years since first exposure   --------------------------------------------------------------------------------
                                           15 to 35                    35+ to 45                    45+
----------------------------------------------------------------------------------------------------------------
0 to 10........................  Every 5 years..............  Every 5 years.............  Every 5 years.
10+............................  Every 5 years..............  Every 2 years.............  Every 1 year.
----------------------------------------------------------------------------------------------------------------

    (4) Termination of employment examinations. (i) The employer shall 
provide, or make available, a termination of employment medical 
examination for any employee who has been exposed to airborne 
concentrations of fibers of asbestos at or above the TWA and/or 
excursion limit.
    (ii) The medical examination shall be in accordance with the 
requirements of the periodic examinations stipulated in paragraph (l)(3) 
of this section, and shall be given within 30 calendar days before or 
after the date of termination of employment.
    (5) Recent examinations. No medical examination is required of any 
employee, if adequate records show that the employee has been examined 
in accordance with any of paragraphs ((l)(2) through (l)(4)) of this 
section within the past 1 year period. A pre- employment medical 
examination which was required as a condition of employment by the 
employer, may not be used by that employer to meet the requirements of 
this paragraph, unless the cost of such examination is borne by the 
employer.
    (6) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this standard and Appendices D and E.
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure.
    (iii) The employee's representative exposure level or anticipated 
exposure level.
    (iv) A description of any personal protective and respiratory 
equipment used or to be used.
    (v) Information from previous medical examinations of the affected 
employee that is not otherwise available to the examining physician.
    (7) Physician's written opinion. (i) The employer shall obtain a 
written opinion from the examining physician. This written opinion shall 
contain the results of the medical examination and shall include:
    (A) The physician's opinion as to whether the employee has any 
detected medical conditions that would place the employee at an 
increased risk of material health impairment from exposure to asbestos;
    (B) Any recommended limitations on the employee or upon the use of 
personal protective equipment such as clothing or respirators;
    (C) A statement that the employee has been informed by the physician 
of the results of the medical examination and of any medical conditions 
resulting from asbestos exposure that require further explanation or 
treatment; and
    (D) A statement that the employee has been informed by the physician 
of

[[Page 30]]

the increased risk of lung cancer attributable to the combined effect of 
smoking and asbestos exposure.
    (ii) The employer shall instruct the physician not to reveal in the 
written opinion given to the employer specific findings or diagnoses 
unrelated to occupational exposure to asbestos.
    (iii) The employer shall provide a copy of the physician's written 
opinion to the affected employee within 30 days from its receipt.
    (m) Recordkeeping--(1) Exposure measurements.

    Note: The employer may utilize the services of competent 
organizations such as industry trade associations and employee 
associations to maintain the records required by this section.

    (i) The employer shall keep an accurate record of all measurements 
taken to monitor employee exposure to asbestos as prescribed in 
paragraph (d) of this section.
    (ii) This record shall include at least the following information:
    (A) The date of measurement;
    (B) The operation involving exposure to asbestos which is being 
monitored;
    (C) Sampling and analytical methods used and evidence of their 
accuracy;
    (D) Number, duration, and results of samples taken;
    (E) Type of respiratory protective devices worn, if any; and
    (F) Name, social security number and exposure of the employees whose 
exposure are represented.
    (iii) The employer shall maintain this record for at least thirty 
(30) years, in accordance with 29 CFR 1910.20.
    (2) Objective data for exempted operations. (i) Where the 
processing, use, or handling of products made from or containing 
asbestos is exempted from other requirements of this section under 
paragraph (d)(2)(iii) of this section, the employer shall establish and 
maintain an accurate record of objective data reasonably relied upon in 
support of the exemption.
    (ii) The record shall include at least the following:
    (A) The product qualifying for exemption;
    (B) The source of the objective data;
    (C) The testing protocol, results of testing, and/or analysis of the 
material for the release of asbestos;
    (D) A description of the operation exempted and how the data support 
the exemption; and
    (E) Other data relevant to the operations, materials, processing, or 
employee exposures covered by the exemption.
    (iii) The employer shall maintain this record for the duration of 
the employer's reliance upon such objective data.
    (3) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance by paragraph (l)(1)(i) of this section, in accordance with 
29 CFR 1910.1020.
    (ii) The record shall include at least the following information:
    (A) The name and social security number of the employee;
    (B) Physician's written opinions;
    (C) Any employee medical complaints related to exposure to asbestos; 
and
    (D) A copy of the information provided to the physician as required 
by paragraph (l)(6) of this section.
    (iii) The employer shall ensure that this record is maintained for 
the duration of employment plus thirty (30) years, in accordance with 29 
CFR 1910.1020.
    (4) Training. The employer shall maintain all employee training 
records for one (1) year beyond the last date of employment of that 
employee.
    (5) Availability. (i) The employer, upon written request, shall make 
all records required to be maintained by this section available to the 
Assistant Secretary and the Director for examination and copying.
    (ii) The employer, upon request shall make any exposure records 
required by paragraph (m)(1) of this section available for examination 
and copying to affected employees, former employees, designated 
representatives and the Assistant Secretary, in accordance with 29 CFR 
1910.1020 (a) through (e) and (g) through (i).
    (iii) The employer, upon request, shall make employee medical 
records required by paragraph (m)(3) of this section available for 
examination and

[[Page 31]]

copying to the subject employee, to anyone having the specific written 
consent of the subject employee, and the Assistant Secretary, in 
accordance with 29 CFR 1910.1020.
    (6) Transfer of records. (i) The employer shall comply with the 
requirements concerning transfer of records set forth in 29 CFR 
1910.1020(h).
    (ii) Whenever the employer ceases to do business and there is no 
successor employer to receive and retain the records for the prescribed 
period, the employer shall notify the Director at least 90 days prior to 
disposal of records and, upon request, transmit them to the Director.
    (n) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees or their designated 
representatives an opportunity to observe any monitoring of employee 
exposure to asbestos conducted in accordance with paragraph (d) of this 
section.
    (2) Observation procedures. When observation of the monitoring of 
employee exposure to asbestos requires entry into an area where the use 
of protective clothing or equipment is required, the observer shall be 
provided with and be required to use such clothing and equipment and 
shall comply with all other applicable safety and health procedures.
    (o) Appendices. (1) Appendices A, C, D, E, and F to this section are 
incorporated as part of this section and the contents of these 
Appendices are mandatory.
    (2) Appendices B, G, H, I, and J to this section are informational 
and are not intended to create any additional obligations not otherwise 
imposed or to detract from any existing obligations.

     Appendix A to Sec. 1910.1001--OSHA Reference Method--Mandatory

    This mandatory appendix specifies the procedure for analyzing air 
samples for asbestos and specifies quality control procedures that must 
be implemented by laboratories performing the analysis. The sampling and 
analytical methods described below represent the elements of the 
available monitoring methods (such as Appendix B of their regulation, 
the most current version of the OSHA method ID-160, or the most current 
version of the NIOSH Method 7400). All employers who are required to 
conduct air monitoring under paragraph (d) of the standard are required 
to utilize analytical laboratories that use this procedure, or an 
equivalent method, for collecting and analyzing samples.

                    Sampling and Analytical Procedure

    1. The sampling medium for air samples shall be mixed cellulose 
ester filter membranes. These shall be designated by the manufacturer as 
suitable for asbestos counting. See below for rejection of blanks.
    2. The preferred collection device shall be the 25-mm diameter 
cassette with an open-faced 50-mm electrically conductive extension 
cowl. The 37-mm cassette may be used if necessary but only if written 
justification for the need to use the 37-mm filter cassette accompanies 
the sample results in the employee's exposure monitoring record. Do not 
reuse or reload cassettes for asbestos sample collection.
    3. An air flow rate between 0.5 liter/min and 2.5 liters/min shall 
be selected for the 25-mm cassette. If the 37-mm cassette is used, an 
air flow rate between 1 liter/min and 2.5 liters/min shall be selected.
    4. Where possible, a sufficient air volume for each air sample shall 
be collected to yield between 100 and 1,300 fibers per square millimeter 
on the membrane filter. If a filter darkens in appearance or if loose 
dust is seen on the filter, a second sample shall be started.
    5. Ship the samples in a rigid container with sufficient packing 
material to prevent dislodging the collected fibers. Packing material 
that has a high electrostatic charge on its surface (e.g., expanded 
polystyrene) cannot be used because such material can cause loss of 
fibers to the sides of the cassette.
    6. Calibrate each personal sampling pump before and after use with a 
representative filter cassette installed between the pump and the 
calibration devices.
    7. Personal samples shall be taken in the ``breathing zone'' of the 
employee (i.e., attached to or near the collar or lapel near the 
worker's face).
    8. Fiber counts shall be made by positive phase contrast using a 
microscope with an 8 to 10 X eyepiece and a 40 to 45 X objective for a 
total magnification of approximately 400 X and a numerical aperture of 
0.65 to 0.75. The microscope shall also be fitted with a green or blue 
filter.
    9. The microscope shall be fitted with a Walton-Beckett eyepiece 
graticule calibrated for a field diameter of 100 micrometers (2 micrometers).
    10. The phase-shift detection limit of the microscope shall be about 
3 degrees measured using the HSE phase shift test slide as outlined 
below.
    a. Place the test slide on the microscope stage and center it under 
the phase objective.

[[Page 32]]

    b. Bring the blocks of grooved lines into focus.

    Note: The slide consists of seven sets of grooved lines (ca. 20 
grooves to each block) in descending order of visibility from sets 1 to 
7, seven being the least visible. The requirements for asbestos counting 
are that the microscope optics must resolve the grooved lines in set 3 
completely, although they may appear somewhat faint, and that the 
grooved lines in sets 6 and 7 must be invisible. Sets 4 and 5 must be at 
least partially visible but may vary slightly in visibility between 
microscopes. A microscope that fails to meet these requirements has 
either too low or too high a resolution to be used for asbestos 
counting.

    c. If the image deteriorates, clean and adjust the microscope 
optics. If the problem persists, consult the microscope manufacturer.
    11. Each set of samples taken will include 10% field blanks or a 
minimum of 2 field blanks. These blanks must come from the same lot as 
the filters used for sample collection. The field blank results shall be 
averaged and subtracted from the analytical results before reporting. A 
set consists of any sample or group of samples for which an evaluation 
for this standard must be made. Any samples represented by a field blank 
having a fiber count in excess of the detection limit of the method 
being used shall be rejected.
    12. The samples shall be mounted by the acetone/triacetin method or 
a method with an equivalent index of refraction and similar clarity.
    13. Observe the following counting rules.
    a. Count only fibers equal to or longer than 5 micrometers. Measure 
the length of curved fibers along the curve.
    b. In the absence of other information, count all particles as 
asbesto that have a length-to-width ratio (aspect ratio) of 3:1 or 
greater.
    c. Fibers lying entirely within the boundary of the Walton-Beckett 
graticule field shall receive a count of 1. Fibers crossing the boundary 
once, having one end within the circle, shall receive the count of one 
half (\1/2\). Do not count any fiber that crosses the graticule boundary 
more than once. Reject and do not count any other fibers even though 
they may be visible outside the graticule area.
    d. Count bundles of fibers as one fiber unless individual fibers can 
be identified by observing both ends of an individual fiber.
    e. Count enough graticule fields to yield 100 fibers. Count a 
minimum of 20 fields; stop counting at 100 fields regardless of fiber 
count.
    14. Blind recounts shall be conducted at the rate of 10 percent.

                       Quality Control Procedures

    1. Intralaboratory program. Each laboratory and/or each company with 
more than one microscopist counting slides shall establish a 
statistically designed quality assurance program involving blind 
recounts and comparisons between microscopists to monitor the 
variability of counting by each microscopist and between microscopists. 
In a company with more than one laboratory, the program shall include 
all laboratories and shall also evaluate the laboratory-to-laboratory 
variability.
    2.a. Interlaboratory program. Each laboratory analyzing asbestos 
samples for compliance determination shall implement an interlaboratory 
quality assurance program that as a minimum includes participation of at 
least two other independent laboratories. Each laboratory shall 
participate in round robin testing at least once every 6 months with at 
least all the other laboratories in its interlaboratory quality 
assurance group. Each laboratory shall submit slides typical of its own 
work load for use in this program. The round robin shall be designed and 
results analyzed using appropriate statistical methodology.
    2.b. All laboratories should also participate in a national sample 
testing scheme such as the Proficiency Analytical Testing Program (PAT), 
or the Asbestos Registry sponsored by the American Industrial Hygiene 
Association (AIHA).
    3. All individuals performing asbestos analysis must have taken the 
NIOSH course for sampling and evaluating airborne asbestos dust or an 
equalivalent course.
    4. When the use of different microscopes contributes to differences 
between counters and laboratories, the effect of the different 
microscope shall be evaluated and the microscope shall be replaced, as 
necessary.
    5. Current results of these quality assurance programs shall be 
posted in each laboratory to keep the microscopists informed.

Appendix B to Sec. 1910.1001--Detailed Procedures for Asbestos Sampling 
                       and Analysis--Non-mandatory

Matrix Air:
  OSHA Permissible Exposure Limits:
    Time Weighted Average..............  0.1 fiber/cc
    Excursion Level (30 minutes).......  1.0 fiber/cc
Collection Procedure:
    A known volume of air is drawn through a 25-mm diameter cassette
containing a mixed-cellulose ester filter. The cassette must be equipped
 with an electrically conductive 50-mm extension cowl. The sampling time
   and rate are chosen to give a fiber density of between 100 to 1,300
                       fibers/mm\2\ on the filter.
Recommended Sampling Rate..............  0.5 to 5.0 liters/minute (L/
                                          min)
Recommended Air Volumes:
    Minimum............................  25 L
    Maximum............................  2,400 L
------------------------------------------------------------------------


[[Page 33]]

    Analytical Procedure: A portion of the sample filter is cleared and 
prepared for asbestos fiber counting by Phase Contrast Microscopy (PCM) 
at 400X.
    Commercial manufacturers and products mentioned in this method are 
for descriptive use only and do not constitute endorsements by USDOL-
OSHA. Similar products from other sources can be substituted.

                             1. Introduction

    This method describes the collection of airborne asbestos fibers 
using calibrated sampling pumps with mixed-cellulose ester (MCE) filters 
and analysis by phase contrast microscopy (PCM). Some terms used are 
unique to this method and are defined below:
    Asbestos: A term for naturally occurring fibrous minerals. Asbestos 
includes chrysotile, crocidolite, amosite (cummingtonite-grunerite 
asbestos), tremolite asbestos, actinolite asbestos, anthophyllite 
asbestos, and any of these minerals that have been chemically treated 
and/or altered. The precise chemical formulation of each species will 
vary with the location from which it was mined. Nominal compositions are 
listed:

Chrysotile................................  Mg3 Si2 O5(OH)4
Crocidolite...............................  Na2 Fe32+ Fe23 + Si8 O22
                                             (OH)\2\
Amosite...................................  (Mg,Fe)7 Si8 O22 (OH)2
Tremolite-actinolite......................  Ca2(Mg,Fe)5 Si8 O22 (OH)2
Anthophyllite.............................  (Mg,Fe)7 Si8 O22 (OH)2
 

    Asbestos Fiber: A fiber of asbestos which meets the criteria 
specified below for a fiber.
    Aspect Ratio: The ratio of the length of a fiber to it's diameter 
(e.g. 3:1, 5:1 aspect ratios).
    Cleavage Fragments: Mineral particles formed by comminution of 
minerals, especially those characterized by parallel sides and a 
moderate aspect ratio (usually less than 20:1).
    Detection Limit: The number of fibers necessary to be 95% certain 
that the result is greater than zero.
    Differential Counting: The term applied to the practice of excluding 
certain kinds of fibers from the fiber count because they do not appear 
to be asbestos.
    Fiber: A particle that is 5 [micro]m or longer, with a length-to-
width ratio of 3 to 1 or longer.
    Field: The area within the graticule circle that is superimposed on 
the microscope image.
    Set: The samples which are taken, submitted to the laboratory, 
analyzed, and for which, interim or final result reports are generated.
    Tremolite, Anthophyllite, and Actinolite: The non-asbestos form of 
these minerals which meet the definition of a fiber. It includes any of 
these minerals that have been chemically treated and/or altered.
    Walton-Beckett Graticule: An eyepiece graticule specifically 
designed for asbestos fiber counting. It consists of a circle with a 
projected diameter of 100 2 [micro]m (area of about 0.00785 mm\2\) with 
a crosshair having tic-marks at 3-[micro]m intervals in one direction 
and 5-[micro]m in the orthogonal direction. There are marks around the 
periphery of the circle to demonstrate the proper sizes and shapes of 
fibers. This design is reproduced in Figure 1. The disk is placed in one 
of the microscope eyepieces so that the design is superimposed on the 
field of view.

                              1.1. History

    Early surveys to determine asbestos exposures were conducted using 
impinger counts of total dust with the counts expressed as million 
particles per cubic foot. The British Asbestos Research Council 
recommended filter membrane counting in 1969. In July 1969, the Bureau 
of Occupational Safety and Health published a filter membrane method for 
counting asbestos fibers in the United States. This method was refined 
by NIOSH and published as P CAM 239. On May 29, 1971, OSHA specified 
filter membrane sampling with phase contrast counting for evaluation of 
asbestos exposures at work sites in the United States. The use of this 
technique was again required by OSHA in 1986. Phase contrast microscopy 
has continued to be the method of choice for the measurement of 
occupational exposure to asbestos.

                             1.2. Principle

    Air is drawn through a MCE filter to capture airborne asbestos 
fibers. A wedge shaped portion of the filter is removed, placed on a 
glass microscope slide and made transparent. A measured area (field) is 
viewed by PCM. All the fibers meeting defined criteria for asbestos are 
counted and considered a measure of the airborne asbestos concentration.

                    1.3. Advantages and Disadvantages

    There are four main advantages of PCM over other methods:
    (1) The technique is specific for fibers. Phase contrast is a fiber 
counting technique which excludes non-fibrous particles from the 
analysis.
    (2) The technique is inexpensive and does not require specialized 
knowledge to carry out the analysis for total fiber counts.
    (3) The analysis is quick and can be performed on-site for rapid 
determination of air concentrations of asbestos fibers.
    (4) The technique has continuity with historical epidemiological 
studies so that estimates of expected disease can be inferred from long-
term determinations of asbestos exposures.
    The main disadvantage of PCM is that it does not positively identify 
asbestos fibers. Other fibers which are not asbestos may be

[[Page 34]]

included in the count unless differential counting is performed. This 
requires a great deal of experience to adequately differentiate asbestos 
from non-asbestos fibers. Positive identification of asbestos must be 
performed by polarized light or electron microscopy techniques. A 
further disadvantage of PCM is that the smallest visible fibers are 
about 0.2 [micro]m in diameter while the finest asbestos fibers may be 
as small as 0.02 [micro]m in diameter. For some exposures, substantially 
more fibers may be present than are actually counted.

                         1.4. Workplace Exposure

    Asbestos is used by the construction industry in such products as 
shingles, floor tiles, asbestos cement, roofing felts, insulation and 
acoustical products. Non-construction uses include brakes, clutch 
facings, paper, paints, plastics, and fabrics. One of the most 
significant exposures in the workplace is the removal and encapsulation 
of asbestos in schools, public buildings, and homes. Many workers have 
the potential to be exposed to asbestos during these operations.
    About 95% of the asbestos in commercial use in the United States is 
chrysotile. Crocidolite and amosite make up most of the remainder. 
Anthophyllite and tremolite or actinolite are likely to be encountered 
as contaminants in various industrial products.

                        1.5. Physical Properties

    Asbestos fiber possesses a high tensile strength along its axis, is 
chemically inert, non-combustible, and heat resistant. It has a high 
electrical resistance and good sound absorbing properties. It can be 
weaved into cables, fabrics or other textiles, and also matted into 
asbestos papers, felts, or mats.

                      2. Range and Detection Limit

    2.1. The ideal counting range on the filter is 100 to 1,300 fibers/
mm\2\. With a Walton-Beckett graticule this range is equivalent to 0.8 
to 10 fibers/field. Using NIOSH counting statistics, a count of 0.8 
fibers/field would give an approximate coefficient of variation (CV) of 
0.13.
    2.2. The detection limit for this method is 4.0 fibers per 100 
fields or 5.5 fibers/mm\2\. This was determined using an equation to 
estimate the maximum CV possible at a specific concentration (95% 
confidence) and a Lower Control Limit of zero. The CV value was then 
used to determine a corresponding concentration from historical CV vs 
fiber relationships. As an example:

Lower Control Limit (95% Confidence) = AC - 1.645(CV)(AC)
Where:

AC = Estimate of the airborne fiber concentration (fibers/cc) Setting 
the Lower Control Limit = 0 and solving for CV:
0 = AC - 1.645(CV)(AC)
CV = 0.61

    This value was compared with CV vs. count curves. The count at which 
CV = 0.61 for Leidel-Busch counting statistics or for an OSHA Salt Lake 
Technical Center (OSHA-SLTC) CV curve (see Appendix A for further 
information) was 4.4 fibers or 3.9 fibers per 100 fields, respectively. 
Although a lower detection limit of 4 fibers per 100 fields is supported 
by the OSHA-SLTC data, both data sets support the 4.5 fibers per 100 
fields value.

              3. Method Performance--Precision and Accuracy

    Precision is dependent upon the total number of fibers counted and 
the uniformity of the fiber distribution on the filter. A general rule 
is to count at least 20 and not more than 100 fields. The count is 
discontinued when 100 fibers are counted, provided that 20 fields have 
already been counted. Counting more than 100 fibers results in only a 
small gain in precision. As the total count drops below 10 fibers, an 
accelerated loss of precision is noted.
    At this time, there is no known method to determine the absolute 
accuracy of the asbestos analysis. Results of samples prepared through 
the Proficiency Analytical Testing (PAT) Program and analyzed by the 
OSHA-SLTC showed no significant bias when compared to PAT reference 
values. The PAT samples were analyzed from 1987 to 1989 (N=36) and the 
concentration range was from 120 to 1,300 fibers/mm\2\.

                            4. Interferences

    Fibrous substances, if present, may interfere with asbestos 
analysis.
    Some common fibers are:
fiberglass
anhydrite
plant fibers
perlite veins
gypsum
some synthetic fibers
membrane structures
sponge spicules
diatoms
microorganisms
wollastonite
    The use of electron microscopy or optical tests such as polarized 
light, and dispersion staining may be used to differentiate these 
materials from asbestos when necessary.

                               5. Sampling

                             5.1. Equipment

    5.1.1. Sample assembly (The assembly is shown in Figure 3). 
Conductive filter holder consisting of a 25-mm diameter, 3-piece 
cassette having a 50-mm long electrically conductive extension cowl. 
Backup pad, 25-mm, cellulose. Membrane filter, mixed-cellulose

[[Page 35]]

ester (MCE), 25-mm, plain, white, 0.4 to 1.2-[micro]m pore size.
    Notes: (a) Do not re-use cassettes.
    (b) Fully conductive cassettes are required to reduce fiber loss to 
the sides of the cassette due to electrostatic attraction.
    (c) Purchase filters which have been selected by the manufacturer 
for asbestos counting or analyze representative filters for fiber 
background before use. Discard the filter lot if more than 4 fibers/100 
fields are found.
    (d) To decrease the possibility of contamination, the sampling 
system (filter-backup pad-cassette) for asbestos is usually preassembled 
by the manufacturer.
    (e) Other cassettes, such as the Bell-mouth, may be used within the 
limits of their validation.
    5.1.2. Gel bands for sealing cassettes.
    5.1.3. Sampling pump.
    Each pump must be a battery operated, self-contained unit small 
enough to be placed on the monitored employee and not interfere with the 
work being performed. The pump must be capable of sampling at the 
collection rate for the required sampling time.
    5.1.4. Flexible tubing, 6-mm bore.
    5.1.5. Pump calibration.
    Stopwatch and bubble tube/burette or electronic meter.
    5.2. Sampling Procedure
    5.2.1. Seal the point where the base and cowl of each cassette meet 
with a gel band or tape.
    5.2.2. Charge the pumps completely before beginning.
    5.2.3. Connect each pump to a calibration cassette with an 
appropriate length of 6-mm bore plastic tubing. Do not use luer 
connectors--the type of cassette specified above has built-in adapters.
    5.2.4. Select an appropriate flow rate for the situation being 
monitored. The sampling flow rate must be between 0.5 and 5.0 L/min for 
personal sampling and is commonly set between 1 and 2 L/min. Always 
choose a flow rate that will not produce overloaded filters.
    5.2.5. Calibrate each sampling pump before and after sampling with a 
calibration cassette in-line (Note: This calibration cassette should be 
from the same lot of cassettes used for sampling). Use a primary 
standard (e.g. bubble burette) to calibrate each pump. If possible, 
calibrate at the sampling site.

    Note: If sampling site calibration is not possible, environmental 
influences may affect the flow rate. The extent is dependent on the type 
of pump used. Consult with the pump manufacturer to determine dependence 
on environmental influences. If the pump is affected by temperature and 
pressure changes, correct the flow rate using the formula shown in the 
section ``Sampling Pump Flow Rate Corrections'' at the end of this 
appendix.

    5.2.6. Connect each pump to the base of each sampling cassette with 
flexible tubing. Remove the end cap of each cassette and take each air 
sample open face. Assure that each sample cassette is held open side 
down in the employee's breathing zone during sampling. The distance from 
the nose/mouth of the employee to the cassette should be about 10 cm. 
Secure the cassette on the collar or lapel of the employee using spring 
clips or other similar devices.
    5.2.7. A suggested minimum air volume when sampling to determine TWA 
compliance is 25 L. For Excursion Limit (30 min sampling time) 
evaluations, a minimum air volume of 48 L is recommended.
    5.2.8. The most significant problem when sampling for asbestos is 
overloading the filter with non-asbestos dust. Suggested maximum air 
sample volumes for specific environments are:

------------------------------------------------------------------------
                 Environment                         Air vol. (L)
------------------------------------------------------------------------
Asbestos removal operations (visible dust)..  100
Asbestos removal operations (little dust)...  240
Office environments.........................  400
                                              to
                                              2,400
------------------------------------------------------------------------

    Caution: Do not overload the filter with dust. High levels of non-
fibrous dust particles may obscure fibers on the filter and lower the 
count or make counting impossible. If more than about 25 to 30% of the 
field area is obscured with dust, the result may be biased low. Smaller 
air volumes may be necessary when there is excessive non-asbestos dust 
in the air.
    While sampling, observe the filter with a small flashlight. If there 
is a visible layer of dust on the filter, stop sampling, remove and seal 
the cassette, and replace with a new sampling assembly. The total dust 
loading should not exceed 1 mg.
    5.2.9. Blank samples are used to determine if any contamination has 
occurred during sample handling. Prepare two blanks for the first 1 to 
20 samples. For sets containing greater than 20 samples, prepare blanks 
as 10% of the samples. Handle blank samples in the same manner as air 
samples with one exception: Do not draw any air through the blank 
samples. Open the blank cassette in the place where the sample cassettes 
are mounted on the employee. Hold it open for about 30 seconds. Close 
and seal the cassette appropriately. Store blanks for shipment with the 
sample cassettes.
    5.2.10. Immediately after sampling, close and seal each cassette 
with the base and plastic plugs. Do not touch or puncture the filter 
membrane as this will invalidate the analysis.
    5.2.11 Attach and secure a sample seal around each sample cassette 
in such a way as to assure that the end cap and base plugs cannot be 
removed without destroying the

[[Page 36]]

seal. Tape the ends of the seal together since the seal is not long 
enough to be wrapped end-to-end. Also wrap tape around the cassette at 
each joint to keep the seal secure.

                          5.3. Sample Shipment

    5.3.1. Send the samples to the laboratory with paperwork requesting 
asbestos analysis. List any known fibrous interferences present during 
sampling on the paperwork. Also, note the workplace operation(s) 
sampled.
    5.3.2. Secure and handle the samples in such that they will not 
rattle during shipment nor be exposed to static electricity. Do not ship 
samples in expanded polystyrene peanuts, vermiculite, paper shreds, or 
excelsior. Tape sample cassettes to sheet bubbles and place in a 
container that will cushion the samples in such a manner that they will 
not rattle.
    5.3.3. To avoid the possibility of sample contamination, always ship 
bulk samples in separate mailing containers.

                               6. Analysis

                         6.1. Safety Precautions

    6.1.1. Acetone is extremely flammable and precautions must be taken 
not to ignite it. Avoid using large containers or quantities of acetone. 
Transfer the solvent in a ventilated laboratory hood. Do not use acetone 
near any open flame. For generation of acetone vapor, use a spark free 
heat source.
    6.1.2. Any asbestos spills should be cleaned up immediately to 
prevent dispersal of fibers. Prudence should be exercised to avoid 
contamination of laboratory facilities or exposure of personnel to 
asbestos. Asbestos spills should be cleaned up with wet methods and/or a 
High Efficiency Particulate-Air (HEPA) filtered vacuum.
    Caution: Do not use a vacuum without a HEPA filter--It will disperse 
fine asbestos fibers in the air.

                             6.2. Equipment

    6.2.1. Phase contrast microscope with binocular or trinocular head.
    6.2.2. Widefield or Huygenian 10X eyepieces (Note: The eyepiece 
containing the graticule must be a focusing eyepiece. Use a 40X phase 
objective with a numerical aperture of 0.65 to 0.75).
    6.2.3. Kohler illumination (if possible) with green or blue filter.
    6.2.4. Walton-Beckett Graticule, type G-22 with 100 2 [micro]m projected diameter.
    6.2.5. Mechanical stage.
    A rotating mechanical stage is convenient for use with polarized 
light.
    6.2.6. Phase telescope.
    6.2.7. Stage micrometer with 0.01-mm subdivisions.
    6.2.8. Phase-shift test slide, mark II (Available from PTR optics 
Ltd., and also McCrone).
    6.2.9. Precleaned glass slides, 25 mm x 75 mm. One end can be 
frosted for convenience in writing sample numbers, etc., or paste-on 
labels can be used.
    6.2.10. Cover glass 1 \1/2\.
    6.2.11. Scalpel (10, curved blade).
    6.2.12. Fine tipped forceps.
    6.2.13. Aluminum block for clearing filter (see Appendix D and 
Figure 4).
    6.2.14. Automatic adjustable pipette, 100- to 500-[micro]L.
    6.2.15. Micropipette, 5 [micro]L.

                              6.3. Reagents

    6.3.1. Acetone (HPLC grade).
    6.3.2. Triacetin (glycerol triacetate).
    6.3.3. Lacquer or nail polish.

                        6.4. Standard Preparation

    A way to prepare standard asbestos samples of known concentration 
has not been developed. It is possible to prepare replicate samples of 
nearly equal concentration. This has been performed through the PAT 
program. These asbestos samples are distributed by the AIHA to 
participating laboratories.
    Since only about one-fourth of a 25-mm sample membrane is required 
for an asbestos count, any PAT sample can serve as a ``standard'' for 
replicate counting.

                          6.5. Sample Mounting

    Note: See Safety Precautions in Section 6.1. before proceeding. The 
objective is to produce samples with a smooth (non-grainy) background in 
a medium with a refractive index of approximately 1.46. The technique 
below collapses the filter for easier focusing and produces permanent 
mounts which are useful for quality control and interlaboratory 
comparison.

    An aluminum block or similar device is required for sample 
preparation.
    6.5.1. Heat the aluminum block to about 70 [deg]C. The hot block 
should not be used on any surface that can be damaged by either the heat 
or from exposure to acetone.
    6.5.2. Ensure that the glass slides and cover glasses are free of 
dust and fibers.
    6.5.3. Remove the top plug to prevent a vacuum when the cassette is 
opened. Clean the outside of the cassette if necessary. Cut the seal 
and/or tape on the cassette with a razor blade. Very carefully separate 
the base from the extension cowl, leaving the filter and backup pad in 
the base.
    6.5.4. With a rocking motion cut a triangular wedge from the filter 
using the scalpel. This wedge should be one-sixth to one-fourth of the 
filter. Grasp the filter wedge with the forceps on the perimeter of the 
filter which was clamped between the cassette pieces. DO NOT TOUCH the 
filter with your

[[Page 37]]

finger. Place the filter on the glass slide sample side up. Static 
electricity will usually keep the filter on the slide until it is 
cleared.
    6.5.5. Place the tip of the micropipette containing about 200 
[micro]L acetone into the aluminum block. Insert the glass slide into 
the receiving slot in the aluminum block. Inject the acetone into the 
block with slow, steady pressure on the plunger while holding the 
pipette firmly in place. Wait 3 to 5 seconds for the filter to clear, 
then remove the pipette and slide from the aluminum block.
    6.5.6. Immediately (less than 30 seconds) place 2.5 to 3.5 [micro]L 
of triacetin on the filter (Note: Waiting longer than 30 seconds will 
result in increased index of refraction and decreased contrast between 
the fibers and the preparation. This may also lead to separation of the 
cover slip from the slide).
    6.5.7. Lower a cover slip gently onto the filter at a slight angle 
to reduce the possibility of forming air bubbles. If more than 30 
seconds have elapsed between acetone exposure and triacetin application, 
glue the edges of the cover slip to the slide with lacquer or nail 
polish.
    6.5.8. If clearing is slow, warm the slide for 15 min on a hot plate 
having a surface temperature of about 50 [deg]C to hasten clearing. The 
top of the hot block can be used if the slide is not heated too long.
    6.5.9. Counting may proceed immediately after clearing and mounting 
are completed.

                          6.6. Sample Analysis

    Completely align the microscope according to the manufacturer's 
instructions. Then, align the microscope using the following general 
alignment routine at the beginning of every counting session and more 
often if necessary.
    6.6.1. Alignment
    (1) Clean all optical surfaces. Even a small amount of dirt can 
significantly degrade the image.
    (2) Rough focus the objective on a sample.
    (3) Close down the field iris so that it is visible in the field of 
view. Focus the image of the iris with the condenser focus. Center the 
image of the iris in the field of view.
    (4) Install the phase telescope and focus on the phase rings. 
Critically center the rings. Misalignment of the rings results in 
astigmatism which will degrade the image.
    (5) Place the phase-shift test slide on the microscope stage and 
focus on the lines. The analyst must see line set 3 and should see at 
least parts of 4 and 5 but, not see line set 6 or 6. A microscope/
microscopist combination which does not pass this test may not be used.
    6.6.2. Counting Fibers
    (1) Place the prepared sample slide on the mechanical stage of the 
microscope. Position the center of the wedge under the objective lens 
and focus upon the sample.
    (2) Start counting from one end of the wedge and progress along a 
radial line to the other end (count in either direction from perimeter 
to wedge tip). Select fields randomly, without looking into the 
eyepieces, by slightly advancing the slide in one direction with the 
mechanical stage control.
    (3) Continually scan over a range of focal planes (generally the 
upper 10 to 15 [micro]m of the filter surface) with the fine focus 
control during each field count. Spend at least 5 to 15 seconds per 
field.
    (4) Most samples will contain asbestos fibers with fiber diameters 
less than 1 [micro]m. Look carefully for faint fiber images. The small 
diameter fibers will be very hard to see. However, they are an important 
contribution to the total count.
    (5) Count only fibers equal to or longer than 5 [micro]m. Measure 
the length of curved fibers along the curve.
    (6) Count fibers which have a length to width ratio of 3:1 or 
greater.
    (7) Count all the fibers in at least 20 fields. Continue counting 
until either 100 fibers are counted or 100 fields have been viewed; 
whichever occurs first. Count all the fibers in the final field.
    (8) Fibers lying entirely within the boundary of the Walton-Beckett 
graticule field shall receive a count of 1. Fibers crossing the boundary 
once, having one end within the circle shall receive a count of \1/2\. 
Do not count any fiber that crosses the graticule boundary more than 
once. Reject and do not count any other fibers even though they may be 
visible outside the graticule area. If a fiber touches the circle, it is 
considered to cross the line.
    (9) Count bundles of fibers as one fiber unless individual fibers 
can be clearly identified and each individual fiber is clearly not 
connected to another counted fiber. See Figure 1 for counting 
conventions.
    (10) Record the number of fibers in each field in a consistent way 
such that filter non-uniformity can be assessed.
    (11) Regularly check phase ring alignment.
    (12) When an agglomerate (mass of material) covers more than 25% of 
the field of view, reject the field and select another. Do not include 
it in the number of fields counted.
    (13) Perform a ``blind recount'' of 1 in every 10 filter wedges 
(slides). Re-label the slides using a person other than the original 
counter.

                        6.7. Fiber Identification

    As previously mentioned in Section 1.3., PCM does not provide 
positive confirmation of asbestos fibers. Alternate differential 
counting techniques should be used if discrimination is desirable. 
Differential counting may include primary discrimination based on 
morphology, polarized light analysis of fibers, or modification of PCM 
data

[[Page 38]]

by Scanning Electron or Transmission Electron Microscopy.
    A great deal of experience is required to routinely and correctly 
perform differential counting. It is discouraged unless it is legally 
necessary. Then, only if a fiber is obviously not asbestos should it be 
excluded from the count. Further discussion of this technique can be 
found in reference 8.10.
    If there is a question whether a fiber is asbestos or not, follow 
the rule:
    ``WHEN IN DOUBT, COUNT.''

         6.8. Analytical Recommendations--Quality Control System

    6.8.1. All individuals performing asbestos analysis must have taken 
the NIOSH course for sampling and evaluating airborne asbestos or an 
equivalent course.
    6.8.2. Each laboratory engaged in asbestos counting shall set up a 
slide trading arrangement with at least two other laboratories in order 
to compare performance and eliminate inbreeding of error. The slide 
exchange occurs at least semiannually. The round robin results shall be 
posted where all analysts can view individual analyst's results.
    6.8.3. Each laboratory engaged in asbestos counting shall 
participate in the Proficiency Analytical Testing Program, the Asbestos 
Analyst Registry or equivalent.
    6.8.4. Each analyst shall select and count prepared slides from a 
``slide bank''. These are quality assurance counts. The slide bank shall 
be prepared using uniformly distributed samples taken from the workload. 
Fiber densities should cover the entire range routinely analyzed by the 
laboratory. These slides are counted blind by all counters to establish 
an original standard deviation. This historical distribution is compared 
with the quality assurance counts. A counter must have 95% of all 
quality control samples counted within three standard deviations of the 
historical mean. This count is then integrated into a new historical 
mean and standard deviation for the slide.
    The analyses done by the counters to establish the slide bank may be 
used for an interim quality control program if the data are treated in a 
proper statistical fashion.

                             7. Calculations

    7.1. Calculate the estimated airborne asbestos fiber concentration 
on the filter sample using the following formula:
where:

AC = Airborne fiber concentration
[GRAPHIC] [TIFF OMITTED] TR10AU94.000

FB = Total number of fibers greater than 5 [micro]m counted
FL = Total number of fields counted on the filter
BFB = Total number of fibers greater than 5 [micro]m counted in the 
blank
BFL = Total number of fields counted on the blank
ECA = Effective collecting area of filter (385 mm\2\ nominal for a 25-mm 
filter.)
FR = Pump flow rate (L/min)
MFA = Microscope count field area (mm\2\). This is 0.00785 mm\2\ for a 
Walton-Beckett Graticule.
T = Sample collection time (min)
1,000 = Conversion of L to cc

    Note: The collection area of a filter is seldom equal to 385 mm\2\. 
It is appropriate for laboratories to routinely monitor the exact 
diameter using an inside micrometer. The collection area is calculated 
according to the formula:

Area = [pi](d/2)\2\

                       7.2. Short-cut Calculation

    Since a given analyst always has the same interpupillary distance, 
the number of fields per filter for a particular analyst will remain 
constant for a given size filter. The field size for that analyst is 
constant (i.e. the analyst is using an assigned microscope and is not 
changing the reticle).
    For example, if the exposed area of the filter is always 385 mm\2\ 
and the size of the field is always 0.00785 mm\2\, the number of fields 
per filter will always be 49,000. In addition it is necessary to convert 
liters of air to cc. These three constants can then be combined such 
that ECA/(1,000 x MFA)=49. The previous equation simplifies to:
[GRAPHIC] [TIFF OMITTED] TR10AU94.001

                        7.3. Recount Calculations

    As mentioned in step 13 of Section 6.6.2., a ``blind recount'' of 
10% of the slides is performed. In all cases, differences will be 
observed between the first and second counts of the same filter wedge. 
Most of these differences will be due to chance alone, that is, due to 
the random variability (precision) of the count method. Statistical 
recount criteria enables one to decide whether observed differences can 
be explained due to chance alone or are probably due to systematic 
differences between analysts, microscopes, or other biasing factors.
    The following recount criterion is for a pair of counts that 
estimate AC in fibers/cc. The criterion is given at the type-I error 
level. That is, there is 5% maximum risk

[[Page 39]]

that we will reject a pair of counts for the reason that one might be 
biased, when the large observed difference is really due to chance.
    Reject a pair of counts if:
    [GRAPHIC] [TIFF OMITTED] TR29JN95.000
    
Where:

AC1 = lower estimated airborne fiber concentration
AC2 = higher estimated airborne fiber concentration
ACavg = average of the two concentration estimates
CVFB = CV for the average of the two concentration estimates

    If a pair of counts are rejected by this criterion then, recount the 
rest of the filters in the submitted set. Apply the test and reject any 
other pairs failing the test. Rejection shall include a memo to the 
industrial hygienist stating that the sample failed a statistical test 
for homogeneity and the true air concentration may be significantly 
different than the reported value.

                         7.4. Reporting Results

    Report results to the industrial hygienist as fibers/cc. Use two 
significant figures. If multiple analyses are performed on a sample, an 
average of the results is to be reported unless any of the results can 
be rejected for cause.

                              8. References

    8.1. Dreesen, W.C., et al, U.S. Public Health Service: A Study of 
Asbestosis in the Asbestos Textile Industry, (Public Health Bulletin No. 
241), US Treasury Dept., Washington, DC, 1938.
    8.2. Asbestos Research Council: The Measurement of Airborne Asbestos 
Dust by the Membrane Filter Method (Technical Note), Asbestos Research 
Council, Rockdale, Lancashire, Great Britain, 1969.
    8.3. Bayer, S.G., Zumwalde, R.D., Brown, T.A., Equipment and 
Procedure for Mounting Millipore Filters and Counting Asbestos Fibers by 
Phase Contrast Microscopy, Bureau of Occupational Health, U.S. Dept. of 
Health, Education and Welfare, Cincinnati, OH, 1969.
    8.4. NIOSH Manual of Analytical Methods, 2nd ed., Vol. 1 (DHEW/NIOSH 
Pub. No. 77-157-A). National Institute for Occupational Safety and 
Health, Cincinnati, OH, 1977. pp. 239-1-239-21.
    8.5. Asbestos, Code of Federal Regulations 29 CFR 1910.1001. 1971.
    8.6. Occupational Exposure to Asbestos, Tremolite, Anthophyllite, 
and Actinolite. Final Rule, Federal Register 51:119 (20 June 1986). 
pp.22612-22790.
    8.7. Asbestos, Tremolite, Anthophyllite, and Actinolite, Code of 
Federal Regulations 1910.1001. 1988. pp 711-752.
    8.8. Criteria for a Recommended Standard--Occupational Exposure to 
Asbestos (DHEW/NIOSH Pub. No. HSM 72-10267), National Institute for 
Occupational Safety and Health NIOSH, Cincinnati,OH, 1972. pp. III-1-
III-24.
    8.9. Leidel, N.A., Bayer,S.G., Zumwalde, R.D.,Busch, K.A., USPHS/
NIOSH Membrane Filter Method for Evaluating Airborne Asbestos Fibers 
(DHEW/NIOSH Pub. No. 79-127). National Institute for Occupational Safety 
and Health, Cincinnati, OH, 1979.
    8.10. Dixon, W.C., Applications of Optical Microscopy in Analysis of 
Asbestos and Quartz, Analytical Techniques in Occupational Health 
Chemistry, edited by D.D. Dollberg and A.W. Verstuyft. Wash. DC: 
American Chemical Society, (ACS Symposium Series 120) 1980. pp. 13-41.

                             Quality Control

    The OSHA asbestos regulations require each laboratory to establish a 
quality control program. The following is presented as an example of how 
the OSHA-SLTC constructed its internal CV curve as part of meeting this 
requirement. Data is from 395 samples collected during OSHA compliance 
inspections and analyzed from October 1980 through April 1986.
    Each sample was counted by 2 to 5 different counters independently 
of one another. The standard deviation and the CV statistic was 
calculated for each sample. This data was then plotted on a graph of CV 
vs. fibers/mm\2\. A least squares regression was performed using the 
following equation:

CV = 
antilog110[A(log10(x))\2\+B(log10(x))+C]


where:

x = the number of fibers/mm\2\

Application of least squares gave:
    A = 0.182205
    B = -0.973343
    C = 0.327499
Using these values, the equation becomes:

CV = antilog10 [0.182205(log10 (x))\2\-
0.973343(log10 (x))+0.327499]

                   Sampling Pump Flow Rate Corrections

    This correction is used if a difference greater than 5% in ambient 
temperature and/or pressure is noted between calibration and sampling 
sites and the pump does not compensate for the differences.
[GRAPHIC] [TIFF OMITTED] TR10AU94.003

Where:


[[Page 40]]


Qact = actual flow rate
Qcal = calibrated flow rate (if a rotameter was used, the 
rotameter value)
Pcal = uncorrected air pressure at calibration
Pact = uncorrected air pressure at sampling site
Tact = temperature at sampling site (K)
Tcal = temperature at calibration (K)

                        Walton-Beckett Graticule

    When ordering the Graticule for asbestos counting, specify the exact 
disc diameter needed to fit the ocular of the microscope and the 
diameter (mm) of the circular counting area. Instructions for measuring 
the dimensions necessary are listed:
    (1) Insert any available graticule into the focusing eyepiece and 
focus so that the graticule lines are sharp and clear.
    (2) Align the microscope.
    (3) Place a stage micrometer on the microscope object stage and 
focus the microscope on the graduated lines.
    (4) Measure the magnified grid length, PL ([micro]m), using the 
stage micrometer.
    (5) Remove the graticule from the microscope and measure its actual 
grid length, AL (mm). This can be accomplished by using a mechanical 
stage fitted with verniers, or a jeweler's loupe with a direct reading 
scale.
    (6) Let D=100 [micro]m. Calculate the circle diameter, dc 
(mm), for the Walton-Beckett graticule and specify the diameter when 
making a purchase:
[GRAPHIC] [TIFF OMITTED] TR10AU94.004

Example: If PL=108 [micro]m, AL=2.93 mm and D=100 [micro]m, then,
[GRAPHIC] [TIFF OMITTED] TR10AU94.005

    (7) Each eyepiece-objective-reticle combination on the microscope 
must be calibrated. Should any of the three be changed (by zoom 
adjustment, disassembly, replacement, etc.), the combination must be 
recalibrated. Calibration may change if interpupillary distance is 
changed. Measure the field diameter, D (acceptable range: 1002 [micro]m) with a stage micrometer upon receipt of the 
graticule from the manufacturer. Determine the field area (mm\2\).

Field Area=[Delta](D/2)\2\
If D=100 [micro]m=0.1 mm, then
Field Area=[Delta](0.1 mm/2)\2\=0.00785 mm\2\
    The Graticule is available from: Graticules Ltd., Morley Road, 
Tonbridge TN9 IRN, Kent, England (Telephone 011-44-732-359061). Also 
available from PTR Optics Ltd., 145 Newton Street, Waltham, MA 02154 
[telephone (617) 891-6000] or McCrone Accessories and Components, 2506 
S. Michigan Ave., Chicago, IL 60616 [phone (312)-842-7100]. The 
graticule is custom made for each microscope.

                   Counts for the Fibers in the Figure
------------------------------------------------------------------------
        Structure No.            Count             Explanation
------------------------------------------------------------------------
 1 to 6......................         1  Single fibers all contained
                                          within the circle.
 7...........................     \1/2\  Fiber crosses circle once.
 8...........................         0  Fiber too short.
 9...........................         2  Two crossing fibers.
10...........................         0  Fiber outside graticule.
11...........................         0  Fiber crosses graticule twice.
12...........................     \1/2\  Although split, fiber only
                                          crosses once.
------------------------------------------------------------------------


[[Page 41]]

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                Appendix C to Sec. 1910.1001 [Reserved]

    Appendix D to Sec. 1910.1001--Medical Questionnaires; Mandatory

    This mandatory appendix contains the medical questionnaires that 
must be administered to all employees who are exposed to asbestos above 
the permissible exposure limit, and who will therefore be included in 
their employer's medical surveillance program. Part 1 of the appendix 
contains the Initial Medical Questionnaire, which must be obtained for 
all new hires who will be covered by the medical surveillance 
requirements. Part 2 includes the abbreviated Periodical Medical 
Questionnaire, which must be administered to all employees who are 
provided periodic medical examinations under the medical surveillance 
provisions of the standard.

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  Appendix E to Sec. 1910.1001--Interpretation and Classification of 
                     Chest Roentgenograms--Mandatory

    (a) Chest roentgenograms shall be interpreted and classified in 
accordance with a professionally accepted Classification system and 
recorded on an interpretation form following the format of the CDC/NIOSH 
(M) 2.8 form. As a minimum, the content within the bold lines of this 
form (items 1 though 4) shall be included. This form is not to be 
submitted to NIOSH.
    (b) Roentgenograms shall be interpreted and classified only by a B-
reader, a board eligible/certified radiologist, or an experienced 
physician with known expertise in pneumoconioses.
    (c) All interpreters, whenever interpreting chest roentgenograms 
made under this section, shall have immediately available for reference 
a complete set of the ILO-U/C International Classification of 
Radiographs for Pneumoconioses, 1980.

 Appendix F to Sec. 1910.1001--Work Practices and Engineering Controls 
  for Automotive Brake and Clutch Inspection, Disassembly, Repair and 
                           Assembly--Mandatory

    This mandatory appendix specifies engineering controls and work 
practices that must be implemented by the employer during automotive 
brake and clutch inspection, disassembly, repair, and assembly 
operations. Proper use of these engineering controls and work practices 
by trained employees will reduce employees' asbestos exposure below the 
permissible exposure level during clutch and brake inspection, 
disassembly, repair, and assembly operations. The employer shall 
institute engineering controls and work practices using either the 
method set forth in paragraph [A] or paragraph [B] of this appendix, or 
any other method which the employer can demonstrate to be equivalent in 
terms of reducing employee exposure to asbestos as defined and which 
meets the requirements described in paragraph [C] of

[[Page 54]]

this appendix, for those facilities in which no more than 5 pairs of 
brakes or 5 clutches are inspected, disassembled, reassembled and/or 
repaired per week, the method set forth in paragraph [D] of this 
appendix may be used:

        [A] Negative Pressure Enclosure/HEPA Vacuum System Method

    (1) The brake and clutch inspection, disassembly, repair, and 
assembly operations shall be enclosed to cover and contain the clutch or 
brake assembly and to prevent the release of asbestos fibers into the 
worker's breathing zone.
    (2) The enclosure shall be sealed tightly and thoroughly inspected 
for leaks before work begins on brake and clutch inspection, 
disassembly, repair, and assembly.
    (3) The enclosure shall be such that the worker can clearly see the 
operation and shall provide impermeable sleeves through which the worker 
can handle the brake and clutch inspection, disassembly, repair and 
assembly. The integrity of the sleeves and ports shall be examined 
before work begins.
    (4) A HEPA-filtered vacuum shall be employed to maintain the 
enclosure under negative pressure throughout the operation. Compressed-
air may be used to remove asbestos fibers or particles from the 
enclosure.
    (5) The HEPA vacuum shall be used first to loosen the asbestos 
containing residue from the brake and clutch parts and then to evacuate 
the loosened asbestos containing material from the enclosure and capture 
the material in the vacuum filter.
    (6) The vacuum's filter, when full, shall be first wetted with a 
fine mist of water, then removed and placed immediately in an 
impermeable container, labeled according to paragraph (j)(4) of this 
section and disposed of according to paragraph (k) of this section.
    (7) Any spills or releases of asbestos containing waste material 
from inside of the enclosure or vacuum hose or vacuum filter shall be 
immediately cleaned up and disposed of according to paragraph (k) of 
this section.

                  [B] Low Pressure/Wet Cleaning Method

    (1) A catch basin shall be placed under the brake assembly, 
positioned to avoid splashes and spills.
    (2) The reservoir shall contain water containing an organic solvent 
or wetting agent. The flow of liquid shall be controlled such that the 
brake assembly is gently flooded to prevent the asbestos-containing 
brake dust from becoming airborne.
    (3) The aqueous solution shall be allowed to flow between the brake 
drum and brake support before the drum is removed.
    (4) After removing the brake drum, the wheel hub and back of the 
brake assembly shall be thoroughly wetted to suppress dust.
    (5) The brake support plate, brake shoes and brake components used 
to attach the brake shoes shall be thoroughly washed before removing the 
old shoes.
    (6) In systems using filters, the filters, when full, shall be first 
wetted with a fine mist of water, then removed and placed immediately in 
an impermeable container, labeled according to paragraph (j)(4) of this 
section and disposed of according to paragraph (k) of this section.
    (7) Any spills of asbestos-containing aqueous solution or any 
asbestos-containing waste material shall be cleaned up immediately and 
disposed of according to paragraph (k) of this section.
    (8) The use of dry brushing during low pressure/wet cleaning 
operations is prohibited.

                         [C] Equivalent Methods

    An equivalent method is one which has sufficient written detail so 
that it can be reproduced and has been demonstrated that the exposures 
resulting from the equivalent method are equal to or less than the 
exposures which would result from the use of the method described in 
paragraph [A] of this appendix. For purposes of making this comparison, 
the employer shall assume that exposures resulting from the use of the 
method described in paragraph [A] of this appendix shall not exceed 
0.016 f/cc, as measured by the OSHA reference method and as averaged 
over at least 18 personal samples.

                             [D] Wet Method.

    (1) A spray bottle, hose nozzle, or other implement capable of 
delivering a fine mist of water or amended water or other delivery 
system capable of delivering water at low pressure, shall be used to 
first thoroughly wet the brake and clutch parts. Brake and clutch 
components shall then be wiped clean with a cloth.
    (2) The cloth shall be placed in an impermeable container, labelled 
according to paragraph (j)(4) of this section and then disposed of 
according to paragraph (k) of this section, or the cloth shall be 
laundered in a way to prevent the release of asbestos fibers in excess 
of 0.1 fiber per cubic centimeter of air.
    (3) Any spills of solvent or any asbestos containing waste material 
shall be cleaned up immediately according to paragraph (k) of this 
section.
    (4) The use of dry brushing during the wet method operations is 
prohibited.

   Appendix G to Sec. 1910.1001--Substance Technical Information for 
                         Asbestos--Non-Mandatory

                       I. Substance Identification

    A. Substance: ``Asbestos'' is the name of a class of magnesium-
silicate minerals that

[[Page 55]]

occur in fibrous form. Minerals that are included in this group are 
chrysotile, crocidolite, amosite, tremolite asbestos, anthophyllite 
asbestos, and actinolite asbestos.
    B. Asbestos is used in the manufacture of heat-resistant clothing, 
automative brake and clutch linings, and a variety of building materials 
including floor tiles, roofing felts, ceiling tiles, asbestos-cement 
pipe and sheet, and fire-resistant drywall. Asbestos is also present in 
pipe and boiler insulation materials, and in sprayed-on materials 
located on beams, in crawlspaces, and between walls.
    C. The potential for a product containing asbestos to release 
breatheable fibers depends on its degree of friability. Friable means 
that the material can be crumbled with hand pressure and is therefore 
likely to emit fibers. The fibrous or fluffy sprayed-on materials used 
for fireproofing, insulation, or sound proofing are considered to be 
friable, and they readily release airborne fibers if disturbed. 
Materials such as vinyl-asbestos floor tile or roofing felts are 
considered nonfriable and generally do not emit airborne fibers unless 
subjected to sanding or sawing operations. Asbestos-cement pipe or sheet 
can emit airborne fibers if the materials are cut or sawed, or if they 
are broken during demolition operations.
    D. Permissible exposure: Exposure to airborne asbestos fibers may 
not exceed 0.2 fibers per cubic centimeter of air (0.1 f/cc) averaged 
over the 8-hour workday.

                         II. Health Hazard Data

    A. Asbestos can cause disabling respiratory disease and various 
types of cancers if the fibers are inhaled. Inhaling or ingesting fibers 
from contaminated clothing or skin can also result in these diseases. 
The symptoms of these diseases generally do not appear for 20 or more 
years after initial exposure.
    B. Exposure to asbestos has been shown to cause lung cancer, 
mesothelioma, and cancer of the stomach and colon. Mesothelioma is a 
rare cancer of the thin membrane lining of the chest and abdomen. 
Symptoms of mesothelioma include shortness of breath, pain in the walls 
of the chest, and/or abdominal pain.

                III. Respirators and Protective Clothing

    A. Respirators: You are required to wear a respirator when 
performing tasks that result in asbestos exposure that exceeds the 
permissible exposure limit (PEL) of 0.1 f/cc. These conditions can occur 
while your employer is in the process of installing engineering controls 
to reduce asbestos exposure, or where engineering controls are not 
feasible to reduce asbestos exposure. Air-purifying respirators equipped 
with a high-efficiency particulate air (HEPA) filter can be used where 
airborne asbestos fiber concentrations do not exceed 2 f/cc; otherwise, 
air-supplied, positive-pressure, full facepiece respirators must be 
used. Disposable respirators or dust masks are not permitted to be used 
for asbestos work. For effective protection, respirators must fit your 
face and head snugly. Your employer is required to conduct fit tests 
when you are first assigned a respirator and every 6 months thereafter. 
Respirators should not be loosened or removed in work situations where 
their use is required.
    B. Protective clothing: You are required to wear protective clothing 
in work areas where asbestos fiber concentrations exceed the permissible 
exposure limit.

                   IV. Disposal Procedures and Cleanup

    A. Wastes that are generated by processes where asbestos is present 
include:
    1. Empty asbestos shipping containers.
    2. Process wastes such as cuttings, trimmings, or reject material.
    3. Housekeeping waste from sweeping or vacuuming.
    4. Asbestos fireproofing or insulating material that is removed from 
buildings.
    5. Building products that contain asbestos removed during building 
renovation or demolition.
    6. Contaminated disposable protective clothing.
    B. Empty shipping bags can be flattened under exhaust hoods and 
packed into airtight containers for disposal. Empty shipping drums are 
difficult to clean and should be sealed.
    C. Vacuum bags or disposable paper filters should not be cleaned, 
but should be sprayed with a fine water mist and placed into a labeled 
waste container.
    D. Process waste and housekeeping waste should be wetted with water 
or a mixture of water and surfactant prior to packaging in disposable 
containers.
    E. Material containing asbestos that is removed from buildings must 
be disposed of in leak-tight 6-mil thick plastic bags, plastic-lined 
cardboard containers, or plastic-lined metal containers. These wastes, 
which are removed while wet, should be sealed in containers before they 
dry out to minimize the release of asbestos fibers during handling.

                        V. Access to Information

    A. Each year, your employer is required to inform you of the 
information contained in this standard and appendices for asbestos. In 
addition, your employer must instruct you in the proper work practices 
for handling materials containing asbestos, and the correct use of 
protective equipment.
    B. Your employer is required to determine whether you are being 
exposed to asbestos. You or your representative has the right to observe 
employee measurements and to

[[Page 56]]

record the results obtained. Your employer is required to inform you of 
your exposure, and, if you are exposed above the permissible limit, he 
or she is required to inform you of the actions that are being taken to 
reduce your exposure to within the permissible limit.
    C. Your employer is required to keep records of your exposures and 
medical examinations. These exposure records must be kept for at least 
thirty (30) years. Medical records must be kept for the period of your 
employment plus thirty (30) years.
    D. Your employer is required to release your exposure and medical 
records to your physician or designated representative upon your written 
request.

   Appendix H to Sec. 1910.1001--Medical Surveillance Guidelines for 
                         Asbestos Non-Mandatory

                 I. Route of Entry Inhalation, Ingestion

                             II. Toxicology

    Clinical evidence of the adverse effects associated with exposure to 
asbestos is present in the form of several well-conducted 
epidemiological studies of occupationally exposed workers, family 
contacts of workers, and persons living near asbestos mines. These 
studies have shown a definite association between exposure to asbestos 
and an increased incidence of lung cancer, pleural and peritoneal 
mesothelioma, gastrointestinal cancer, and asbestosis. The latter is a 
disabling fibrotic lung disease that is caused only by exposure to 
asbestos. Exposure to asbestos has also been associated with an 
increased incidence of esophageal, kidney, laryngeal, pharyngeal, and 
buccal cavity cancers. As with other known chronic occupational 
diseases, disease associated with asbestos generally appears about 20 
years following the first occurrence of exposure: There are no known 
acute effects associated with exposure to asbestos.
    Epidemiological studies indicate that the risk of lung cancer among 
exposed workers who smoke cigarettes is greatly increased over the risk 
of lung cancer among non-exposed smokers or exposed nonsmokers. These 
studies suggest that cessation of smoking will reduce the risk of lung 
cancer for a person exposed to asbestos but will not reduce it to the 
same level of risk as that existing for an exposed worker who has never 
smoked.

           III. Signs and Symptoms of Exposure-Related Disease

    The signs and symptoms of lung cancer or gastrointestinal cancer 
induced by exposure to asbestos are not unique, except that a chest X-
ray of an exposed patient with lung cancer may show pleural plaques, 
pleural calcification, or pleural fibrosis. Symptoms characteristic of 
mesothelioma include shortness of breath, pain in the walls of the 
chest, or abdominal pain. Mesothelioma has a much longer latency period 
compared with lung cancer (40 years versus 15-20 years), and 
mesothelioma is therefore more likely to be found among workers who were 
first exposed to asbestos at an early age. Mesothelioma is always fatal.
    Asbestosis is pulmonary fibrosis caused by the accumulation of 
asbestos fibers in the lungs. Symptoms include shortness of breath, 
coughing, fatigue, and vague feelings of sickness. When the fibrosis 
worsens, shortness of breath occurs even at rest. The diagnosis of 
asbestosis is based on a history of exposure to asbestos, the presence 
of characteristic radiologic changes, end-inspiratory crackles (rales), 
and other clinical features of fibrosing lung disease. Pleural plaques 
and thickening are observed on X-rays taken during the early stages of 
the disease. Asbestosis is often a progressive disease even in the 
absence of continued exposure, although this appears to be a highly 
individualized characteristic. In severe cases, death may be caused by 
respiratory or cardiac failure.

             IV. Surveillance and Preventive Considerations

    As noted above, exposure to asbestos has been linked to an increased 
risk of lung cancer, mesothelioma, gastrointestinal cancer, and 
asbestosis among occupationally exposed workers. Adequate screening 
tests to determine an employee's potential for developing serious 
chronic diseases, such as cancer, from exposure to asbestos do not 
presently exist. However, some tests, particularly chest X-rays and 
pulmonary function tests, may indicate that an employee has been 
overexposed to asbestos increasing his or her risk of developing 
exposure-related chronic diseases. It is important for the physician to 
become familiar with the operating conditions in which occupational 
exposure to asbestos is likely to occur. This is particularly important 
in evaluating medical and work histories and in conducting physical 
examinations. When an active employee has been identified as having been 
overexposed to asbestos, measures taken by the employer to eliminate or 
mitigate further exposure should also lower the risk of serious long-
term consequences.
    The employer is required to institute a medical surveillance program 
for all employees who are or will be exposed to asbestos at or above the 
permissible exposure limit (0.1 fiber per cubic centimeter of air). All 
examinations and procedures must be performed by or under the 
supervision of a licensed physician, at a reasonable time and place, and 
at no cost to the employee.
    Although broad latitude is given to the physician in prescribing 
specific tests to be

[[Page 57]]

included in the medical surveillance program, OSHA requires inclusion of 
the following elements in the routine examination:
    (i) Medical and work histories with special emphasis directed to 
symptoms of the respiratory system, cardiovascular system, and digestive 
tract.
    (ii) Completion of the respiratory disease questionnaire contained 
in Appendix D.
    (iii) A physical examination including a chest roentgenogram and 
pulmonary function test that includes measurement of the employee's 
forced vital capacity (FVC) and forced expiratory volume at one second 
(FEV1).
    (iv) Any laboratory or other test that the examining physician deems 
by sound medical practice to be necessary.
    The employer is required to make the prescribed tests available at 
least annually to those employees covered; more often than specified if 
recommended by the examining physician; and upon termination of 
employment.
    The employer is required to provide the physician with the following 
information: A copy of this standard and appendices; a description of 
the mployee's duties as they relate to asbestos exposure; the employee's 
representative level of exposure to asbestos; a description of any 
personal protective and respiratory equipment used; and information from 
previous medical examinations of the affected employee that is not 
otherwise available to the physician. Making this information available 
to the physician will aid in the evaluation of the employee's health in 
relation to assigned duties and fitness to wear personal protective 
equipment, if required.
    The employer is required to obtain a written opinion from the 
examining physician containing the results of the medical examination; 
the physician's opinion as to whether the employee has any detected 
medical conditions that would place the employee at an increased risk of 
exposure-related disease; any recommended limitations on the employee or 
on the use of personal protective equipment; and a statement that the 
employee has been informed by the physician of the results of the 
medical examination and of any medical conditions related to asbestos 
exposure that require further explanation or treatment. This written 
opinion must not reveal specific findings or diagnoses unrelated to 
exposure to asbestos, and a copy of the opinion must be provided to the 
affected employee.

Appendix I to Sec. 1910.1001--Smoking Cessation Program Information For 
                         Asbestos--Non-Mandatory

    The following organizations provide smoking cessation information 
and program material.
    1. The National Cancer Institute operates a toll-free Cancer 
Information Service (CIS) with trained personnel to help you. Call 1-
800-4-CANCER* to reach the CIS office serving your area, or write: 
Office of Cancer Communications, National Cancer Institute, National 
Institutes of Health, Building 31, Room 10A24, Bethesda, Maryland 20892.
    2. American Cancer Society, 3340 Peachtree Road, NE., Atlanta, 
Georgia 30062, (404) 320-3333.
    The American Cancer Society (ACS) is a voluntary organization 
composed of 58 divisions and 3,100 local units. Through ``The Great 
American Smokeout'' in November, the annual Cancer Crusade in April, and 
numerous educational materials, ACS helps people learn about the health 
hazards of smoking and become successful ex-smokers.
    3. American Heart Association, 7320 Greenville Avenue, Dallas, Texas 
75231, (214) 750-5300.
    The American Heart Association (AHA) is a voluntary organization 
with 130,000 members (physicians, scientists, and laypersons) in 55 
state and regional groups. AHA produces a variety of publications and 
audiovisual materials about the effects of smoking on the heart. AHA 
also has developed a guidebook for incorporating a weight-control 
component into smoking cessation programs.
    4. American Lung Association, 1740 Broadway, New York, New York 
10019, (212) 245-8000.
    A voluntary organization of 7,500 members (physicians, nurses, and 
laypersons), the American Lung Association (ALA) conducts numerous 
public information programs about the health effect of smoking. ALA has 
59 state and 85 local units. The organization actively supports 
legislation and information campaigns for non-smokers' rights and 
provides help for smokers who want to quit, for example, through 
``Freedom From Smoking,'' a self-help smoking cessation program.
    5. Office on Smoking and Health, U.S. Department of Health and, 
Human Services, 5600 Fishers Lane, Park Building, Room 110, Rockville, 
Maryland 20857.
    The Office on Smoking and Health (OSH) is the Department of Health 
and Human Services' lead agency in smoking control. OSH has sponsored 
distribution of publications on smoking-realted topics, such as free 
flyers on relapse after initial quitting, helping a friend or family 
member quit smoking, the health hazards of smoking, and the effects of 
parental smoking on teenagers.
    *In Hawaii, on Oahu call 524-1234 (call collect from neighboring 
islands),
    Spanish-speaking staff members are available during daytime hours to 
callers from the following areas: California, Florida, Georgia, 
Illinois, New Jersey (area code 210), New York, and Texas. Consult your 
local

[[Page 58]]

telephone directory for listings of local chapters.

 Appendix J to Sec. 1910.1001--Polarized Light Microscopy of Asbestos--
                              Non-Mandatory

Method number: ID-191
Matrix: Bulk

                          Collection Procedure

    Collect approximately 1 to 2 grams of each type of material and 
place into separate 20 mL scintillation vials.

                          Analytical Procedure

    A portion of each separate phase is analyzed by gross examination, 
phase-polar examination, and central stop dispersion microscopy.
    Commercial manufacturers and products mentioned in this method are 
for descriptive use only and do not constitute endorsements by USDOL-
OSHA. Similar products from other sources may be substituted.

                             1. Introduction

    This method describes the collection and analysis of asbestos bulk 
materials by light microscopy techniques including phase- polar 
illumination and central-stop dispersion microscopy. Some terms unique 
to asbestos analysis are defined below:
    Amphibole: A family of minerals whose crystals are formed by long, 
thin units which have two thin ribbons of double chain silicate with a 
brucite ribbon in between. The shape of each unit is similar to an ``I 
beam''. Minerals important in asbestos analysis include cummingtonite-
grunerite, crocidolite, tremolite-actinolite and anthophyllite.
    Asbestos: A term for naturally occurring fibrous minerals. Asbestos 
includes chrysotile, cummingtonite-grunerite asbestos (amosite), 
anthophyllite asbestos, tremolite asbestos, crocidolite, actinolite 
asbestos and any of these minerals which have been chemically treated or 
altered. The precise chemical formulation of each species varies with 
the location from which it was mined. Nominal compositions are listed:

 Chrysotile...............................Mg3 Si2 
                                           O5(OH)4
                Crocidolite (Riebeckite asbestos)........Na2 
                   Fe3\2+\ Fe2\3+\ Si8 
                                          O22(OH)2
Cummingtonite-Grunerite asbestos (Amosite)..........(Mg,Fe)7 
                           Si8 O22(OH)2
             Tremolite-Actinolite asbestos................Ca2
                                     (Mg,Fe)5 Si8 
                                          O22(OH)2
  Anthophyllite asbestos.............(Mg,Fe)7 Si8 
                                          O22(OH)2
    Asbestos Fiber: A fiber of asbestos meeting the criteria for a 
fiber. (See section 3.5.)
    Aspect Ratio: The ratio of the length of a fiber to its diameter 
usually defined as ``length : width'', e.g. 3:1.
    Brucite: A sheet mineral with the composition Mg(OH)2.
    Central Stop Dispersion Staining (microscope): This is a dark field 
microscope technique that images particles using only light refracted by 
the particle, excluding light that travels through the particle 
unrefracted. This is usually accomplished with a McCrone objective or 
other arrangement which places a circular stop with apparent aperture 
equal to the objective aperture in the back focal plane of the 
microscope.
    Cleavage Fragments: Mineral particles formed by the comminution of 
minerals, especially those characterized by relatively parallel sides 
and moderate aspect ratio.
    Differential Counting: The term applied to the practice of excluding 
certain kinds of fibers from a phase contrast asbestos count because 
they are not asbestos.
    Fiber: A particle longer than or equal to 5 [micro]m with a length 
to width ratio greater than or equal to 3:1. This may include cleavage 
fragments. (see section 3.5 of this appendix).
    Phase Contrast: Contrast obtained in the microscope by causing light 
scattered by small particles to destructively interfere with unscattered 
light, thereby enhancing the visibility of very small particles and 
particles with very low intrinsic contrast.
    Phase Contrast Microscope: A microscope configured with a phase mask 
pair to create phase contrast. The technique which uses this is called 
Phase Contrast Microscopy (PCM).
    Phase-Polar Analysis: This is the use of polarized light in a phase 
contrast microscope. It is used to see the same size fibers that are 
visible in air filter analysis. Although fibers finer than 1 [micro]m 
are visible, analysis of these is inferred from analysis of larger 
bundles that are usually present.
    Phase-Polar Microscope: The phase-polar microscope is a phase 
contrast microscope which has an analyzer, a polarizer, a first order 
red plate and a rotating phase condenser all in place so that the 
polarized light image is enhanced by phase contrast.
    Sealing Encapsulant: This is a product which can be applied, 
preferably by spraying, onto an asbestos surface which will seal the 
surface so that fibers cannot be released.
    Serpentine: A mineral family consisting of minerals with the general 
composition Mg3(Si2O5(OH)4 having the 
magnesium in brucite layer over a silicate layer. Minerals important in 
asbestos analysis included in this family are chrysotile, lizardite, 
antigorite.

                              1.1. History

    Light microscopy has been used for well over 100 years for the 
determination of mineral species. This analysis is carried out using 
specialized polarizing microscopes as well as bright field microscopes. 
The identification of minerals is an on-going process with many new 
minerals described each year. The first recorded use of asbestos was

[[Page 59]]

in Finland about 2500 B.C. where the material was used in the mud wattle 
for the wooden huts the people lived in as well as strengthening for 
pottery. Adverse health aspects of the mineral were noted nearly 2000 
years ago when Pliny the Younger wrote about the poor health of slaves 
in the asbestos mines. Although known to be injurious for centuries, the 
first modern references to its toxicity were by the British Labor 
Inspectorate when it banned asbestos dust from the workplace in 1898. 
Asbestosis cases were described in the literature after the turn of the 
century. Cancer was first suspected in the mid 1930's and a causal link 
to mesothelioma was made in 1965. Because of the public concern for 
worker and public safety with the use of this material, several 
different types of analysis were applied to the determination of 
asbestos content. Light microscopy requires a great deal of experience 
and craft. Attempts were made to apply less subjective methods to the 
analysis. X-ray diffraction was partially successful in determining the 
mineral types but was unable to separate out the fibrous portions from 
the non-fibrous portions. Also, the minimum detection limit for asbestos 
analysis by X-ray diffraction (XRD) is about 1%. Differential Thermal 
Analysis (DTA) was no more successful. These provide useful 
corroborating information when the presence of asbestos has been shown 
by microscopy; however, neither can determine the difference between 
fibrous and non-fibrous minerals when both habits are present. The same 
is true of Infrared Absorption (IR).
    When electron microscopy was applied to asbestos analysis, hundreds 
of fibers were discovered present too small to be visible in any light 
microscope. There are two different types of electron microscope used 
for asbestos analysis: Scanning Electron Microscope (SEM) and 
Transmission Electron Microscope (TEM). Scanning Electron Microscopy is 
useful in identifying minerals. The SEM can provide two of the three 
pieces of information required to identify fibers by electron 
microscopy: morphology and chemistry. The third is structure as 
determined by Selected Area Electron Diffraction--SAED which is 
performed in the TEM. Although the resolution of the SEM is sufficient 
for very fine fibers to be seen, accuracy of chemical analysis that can 
be performed on the fibers varies with fiber diameter in fibers of less 
than 0.2 [micro]m diameter. The TEM is a powerful tool to identify 
fibers too small to be resolved by light microscopy and should be used 
in conjunction with this method when necessary. The TEM can provide all 
three pieces of information required for fiber identification. Most 
fibers thicker than 1 [micro]m can adequately be defined in the light 
microscope. The light microscope remains as the best instrument for the 
determination of mineral type. This is because the minerals under 
investigation were first described analytically with the light 
microscope. It is inexpensive and gives positive identification for most 
samples analyzed. Further, when optical techniques are inadequate, there 
is ample indication that alternative techniques should be used for 
complete identification of the sample.

                             1.2. Principle

    Minerals consist of atoms that may be arranged in random order or in 
a regular arrangement. Amorphous materials have atoms in random order 
while crystalline materials have long range order. Many materials are 
transparent to light, at least for small particles or for thin sections. 
The properties of these materials can be investigated by the effect that 
the material has on light passing through it. The six asbestos minerals 
are all crystalline with particular properties that have been identified 
and cataloged. These six minerals are anisotropic. They have a regular 
array of atoms, but the arrangement is not the same in all directions. 
Each major direction of the crystal presents a different regularity. 
Light photons travelling in each of these main directions will encounter 
different electrical neighborhoods, affecting the path and time of 
travel. The techniques outlined in this method use the fact that light 
traveling through fibers or crystals in different directions will behave 
differently, but predictably. The behavior of the light as it travels 
through a crystal can be measured and compared with known or determined 
values to identify the mineral species. Usually, Polarized Light 
Microscopy (PLM) is performed with strain-free objectives on a bright-
field microscope platform. This would limit the resolution of the 
microscope to about 0.4 [micro]m. Because OSHA requires the counting and 
identification of fibers visible in phase contrast, the phase contrast 
platform is used to visualize the fibers with the polarizing elements 
added into the light path. Polarized light methods cannot identify 
fibers finer than about 1 [micro]m in diameter even though they are 
visible. The finest fibers are usually identified by inference from the 
presence of larger, identifiable fiber bundles. When fibers are present, 
but not identifiable by light microscopy, use either SEM or TEM to 
determine the fiber identity.

                    1.3. Advantages and Disadvantages

    The advantages of light microcopy are:
    (a) Basic identification of the materials was first performed by 
light microscopy and gross analysis. This provides a large base of 
published information against which to check analysis and analytical 
technique.
    (b) The analysis is specific to fibers. The minerals present can 
exist in asbestiform, fibrous, prismatic, or massive varieties all at

[[Page 60]]

the same time. Therefore, bulk methods of analysis such as X-ray 
diffraction, IR analysis, DTA, etc. are inappropriate where the material 
is not known to be fibrous.
    (c) The analysis is quick, requires little preparation time, and can 
be performed on-site if a suitably equipped microscope is available.
    The disadvantages are:
    (a) Even using phase-polar illumination, not all the fibers present 
may be seen. This is a problem for very low asbestos concentrations 
where agglomerations or large bundles of fibers may not be present to 
allow identification by inference.
    (b) The method requires a great degree of sophistication on the part 
of the microscopist. An analyst is only as useful as his mental catalog 
of images. Therefore, a microscopist's accuracy is enhanced by 
experience. The mineralogical training of the analyst is very important. 
It is the basis on which subjective decisions are made.
    (c) The method uses only a tiny amount of material for analysis. 
This may lead to sampling bias and false results (high or low). This is 
especially true if the sample is severely inhomogeneous.
    (d) Fibers may be bound in a matrix and not distinguishable as 
fibers so identification cannot be made.

                         1.4. Method Performance

    1.4.1. This method can be used for determination of asbestos content 
from 0 to 100% asbestos. The detection limit has not been adequately 
determined, although for selected samples, the limit is very low, 
depending on the number of particles examined. For mostly homogeneous, 
finely divided samples, with no difficult fibrous interferences, the 
detection limit is below 1%. For inhomogeneous samples (most samples), 
the detection limit remains undefined. NIST has conducted proficiency 
testing of laboratories on a national scale. Although each round is 
reported statistically with an average, control limits, etc., the 
results indicate a difficulty in establishing precision especially in 
the low concentration range. It is suspected that there is significant 
bias in the low range especially near 1%. EPA tried to remedy this by 
requiring a mandatory point counting scheme for samples less than 10%. 
The point counting procedure is tedious, and may introduce significant 
biases of its own. It has not been incorporated into this method.
    1.4.2. The precision and accuracy of the quantitation tests 
performed in this method are unknown. Concentrations are easier to 
determine in commercial products where asbestos was deliberately added 
because the amount is usually more than a few percent. An analyst's 
results can be ``calibrated'' against the known amounts added by the 
manufacturer. For geological samples, the degree of homogeneity affects 
the precision.
    1.4.3. The performance of the method is analyst dependent. The 
analyst must choose carefully and not necessarily randomly the portions 
for analysis to assure that detection of asbestos occurs when it is 
present. For this reason, the analyst must have adequate training in 
sample preparation, and experience in the location and identification of 
asbestos in samples. This is usually accomplished through substantial 
on-the-job training as well as formal education in mineralogy and 
microscopy.

                           1.5. Interferences

    Any material which is long, thin, and small enough to be viewed 
under the microscope can be considered an interference for asbestos. 
There are literally hundreds of interferences in workplaces. The 
techniques described in this method are normally sufficient to eliminate 
the interferences. An analyst's success in eliminating the interferences 
depends on proper training.
    Asbestos minerals belong to two mineral families: the serpentines 
and the amphiboles. In the serpentine family, the only common fibrous 
mineral is chrysotile. Occasionally, the mineral antigorite occurs in a 
fibril habit with morphology similar to the amphiboles. The amphibole 
minerals consist of a score of different minerals of which only five are 
regulated by federal standard: amosite, crocidolite, anthophyllite 
asbestos, tremolite asbestos and actinolite asbestos. These are the only 
amphibole minerals that have been commercially exploited for their 
fibrous properties; however, the rest can and do occur occasionally in 
asbestiform habit.
    In addition to the related mineral interferences, other minerals 
common in building material may present a problem for some 
microscopists: gypsum, anhydrite, brucite, quartz fibers, talc fibers or 
ribbons, wollastonite, perlite, attapulgite, etc. Other fibrous 
materials commonly present in workplaces are: fiberglass, mineral wool, 
ceramic wool, refractory ceramic fibers, kevlar, nomex, synthetic 
fibers, graphite or carbon fibers, cellulose (paper or wood) fibers, 
metal fibers, etc.
    Matrix embedding material can sometimes be a negative interference. 
The analyst may not be able to easily extract the fibers from the matrix 
in order to use the method. Where possible, remove the matrix before the 
analysis, taking careful note of the loss of weight. Some common matrix 
materials are: vinyl, rubber, tar, paint, plant fiber, cement, and 
epoxy. A further negative interference is that the asbestos fibers 
themselves may be either too small to be seen in Phase contrast 
Microscopy (PCM) or of a very low fibrous quality, having the appearance 
of plant fibers. The analyst's ability to deal with these materials 
increases with experience.

[[Page 61]]

                   1.6. Uses and Occupational Exposure

    Asbestos is ubiquitous in the environment. More than 40% of the land 
area of the United States is composed of minerals which may contain 
asbestos. Fortunately, the actual formation of great amounts of asbestos 
is relatively rare. Nonetheless, there are locations in which 
environmental exposure can be severe such as in the Serpentine Hills of 
California.
    There are thousands of uses for asbestos in industry and the home. 
Asbestos abatement workers are the most current segment of the 
population to have occupational exposure to great amounts of asbestos. 
If the material is undisturbed, there is no exposure. Exposure occurs 
when the asbestos-containing material is abraded or otherwise disturbed 
during maintenance operations or some other activity. Approximately 95% 
of the asbestos in place in the United States is chrysotile.
    Amosite and crocidolite make up nearly all the difference. Tremolite 
and anthophyllite make up a very small percentage. Tremolite is found in 
extremely small amounts in certain chrysotile deposits. Actinolite 
exposure is probably greatest from environmental sources, but has been 
identified in vermiculite containing, sprayed-on insulating materials 
which may have been certified as asbestos-free.

                  1.7. Physical and Chemical Properties

    The nominal chemical compositions for the asbestos minerals were 
given in Section 1. Compared to cleavage fragments of the same minerals, 
asbestiform fibers possess a high tensile strength along the fiber axis. 
They are chemically inert, non- combustible, and heat resistant. Except 
for chrysotile, they are insoluble in Hydrochloric acid (HCl). 
Chrysotile is slightly soluble in HCl. Asbestos has high electrical 
resistance and good sound absorbing characteristics. It can be woven 
into cables, fabrics or other textiles, or matted into papers, felts, 
and mats.

1.8. Toxicology (This Section is for Information Only and Should Not Be 
                          Taken as OSHA Policy)

    Possible physiologic results of respiratory exposure to asbestos are 
mesothelioma of the pleura or peritoneum, interstitial fibrosis, 
asbestosis, pneumoconiosis, or respiratory cancer. The possible 
consequences of asbestos exposure are detailed in the NIOSH Criteria 
Document or in the OSHA Asbestos Standards 29 CFR 1910.1001 and 29 CFR 
1926.1101 and 29 CFR 1915.1001.

                          2. Sampling Procedure

                       2.1. Equipment for Sampling

    (a) Tube or cork borer sampling device
    (b) Knife
    (c) 20 mL scintillation vial or similar vial
    (d) Sealing encapsulant

                         2.2. Safety Precautions

    Asbestos is a known carcinogen. Take care when sampling. While in an 
asbestos-containing atmosphere, a properly selected and fit-tested 
respirator should be worn. Take samples in a manner to cause the least 
amount of dust. Follow these general guidelines:
    (a) Do not make unnecessary dust.
    (b) Take only a small amount (1 to 2 g).
    (c) Tightly close the sample container.
    (d) Use encapsulant to seal the spot where the sample was taken, if 
necessary.

                         2.3. Sampling Procedure

    Samples of any suspect material should be taken from an 
inconspicuous place. Where the material is to remain, seal the sampling 
wound with an encapsulant to eliminate the potential for exposure from 
the sample site. Microscopy requires only a few milligrams of material. 
The amount that will fill a 20 mL scintillation vial is more than 
adequate. Be sure to collect samples from all layers and phases of 
material. If possible, make separate samples of each different phase of 
the material. This will aid in determining the actual hazard. DO NOT USE 
ENVELOPES, PLASTIC OR PAPER BAGS OF ANY KIND TO COLLECT SAMPLES. The use 
of plastic bags presents a contamination hazard to laboratory personnel 
and to other samples. When these containers are opened, a bellows effect 
blows fibers out of the container onto everything, including the person 
opening the container.
    If a cork-borer type sampler is available, push the tube through the 
material all the way, so that all layers of material are sampled. Some 
samplers are intended to be disposable. These should be capped and sent 
to the laboratory. If a non-disposable cork borer is used, empty the 
contents into a scintillation vial and send to the laboratory. 
Vigorously and completely clean the cork borer between samples.

                              2.4 Shipment

    Samples packed in glass vials must not touch or they might break in 
shipment.
    (a) Seal the samples with a sample seal over the end to guard 
against tampering and to identify the sample.
    (b) Package the bulk samples in separate packages from the air 
samples. They may cross-contaminate each other and will invalidate the 
results of the air samples.
    (c) Include identifying paperwork with the samples, but not in 
contact with the suspected asbestos.
    (d) To maintain sample accountability, ship the samples by certified 
mail, overnight express, or hand carry them to the laboratory.

[[Page 62]]

                               3. Analysis

    The analysis of asbestos samples can be divided into two major 
parts: sample preparation and microscopy. Because of the different 
asbestos uses that may be encountered by the analyst, each sample may 
need different preparation steps. The choices are outlined below. There 
are several different tests that are performed to identify the asbestos 
species and determine the percentage. They will be explained below.

                               3.1. Safety

    (a) Do not create unnecessary dust. Handle the samples in HEPA-
filter equipped hoods. If samples are received in bags, envelopes or 
other inappropriate container, open them only in a hood having a face 
velocity at or greater than 100 fpm. Transfer a small amount to a 
scintillation vial and only handle the smaller amount.
    (b) Open samples in a hood, never in the open lab area.
    (c) Index of refraction oils can be toxic. Take care not to get this 
material on the skin. Wash immediately with soap and water if this 
happens.
    (d) Samples that have been heated in the muffle furnace or the 
drying oven may be hot. Handle them with tongs until they are cool 
enough to handle.
    (e) Some of the solvents used, such as THF (tetrahydrofuran), are 
toxic and should only be handled in an appropriate fume hood and 
according to instructions given in the Material Safety Data Sheet 
(MSDS).

                             3.2. Equipment

    (a) Phase contrast microscope with 10x, 16x and 40x objectives, 10x 
wide-field eyepieces, G-22 Walton-Beckett graticule, Whipple disk, 
polarizer, analyzer and first order red or gypsum plate, 100 Watt 
illuminator, rotating position condenser with oversize phase rings, 
central stop dispersion objective, Kohler illumination and a rotating 
mechanical stage.
    (b) Stereo microscope with reflected light illumination, transmitted 
light illumination, polarizer, analyzer and first order red or gypsum 
plate, and rotating stage.
    (c) Negative pressure hood for the stereo microscope
    (d) Muffle furnace capable of 600 [deg]C
    (e) Drying oven capable of 50-150 [deg]C
    (f) Aluminum specimen pans
    (g) Tongs for handling samples in the furnace
    (h) High dispersion index of refraction oils (Special for dispersion 
staining.)

n = 1.550
n = 1.585
n = 1.590
n = 1.605
n = 1.620
n = 1.670
n = 1.680
n = 1.690

    (i) A set of index of refraction oils from about n=1.350 to n=2.000 
in n=0.005 increments. (Standard for Becke line analysis.)
    (j) Glass slides with painted or frosted ends 1x3 inches 1mm thick, 
precleaned.
    (k) Cover Slips 22x22 mm, 1\1/2\
    (l) Paper clips or dissection needles
    (m) Hand grinder
    (n) Scalpel with both 10 and 11 blades
    (o) 0.1 molar HCl
    (p) Decalcifying solution (Baxter Scientific Products) 
Ethylenediaminetetraacetic Acid,

Tetrasodium......................................................0.7 g/l
Sodium Potassium Tartrate...................................8.0 mg/liter
Hydrochloric Acid...........................................99.2 g/liter
Sodium Tartrate.............................................0.14 g/liter

    (q) Tetrahydrofuran (THF)
    (r) Hotplate capable of 60 [deg]C
    (s) Balance
    (t) Hacksaw blade
    (u) Ruby mortar and pestle

                       3.3. Sample Pre-Preparation

    Sample preparation begins with pre-preparation which may include 
chemical reduction of the matrix, heating the sample to dryness or 
heating in the muffle furnace. The end result is a sample which has been 
reduced to a powder that is sufficiently fine to fit under the cover 
slip. Analyze different phases of samples separately, e.g., tile and the 
tile mastic should be analyzed separately as the mastic may contain 
asbestos while the tile may not.

                             (a) Wet samples

    Samples with a high water content will not give the proper 
dispersion colors and must be dried prior to sample mounting. Remove the 
lid of the scintillation vial, place the bottle in the drying oven and 
heat at 100 [deg]C to dryness (usually about 2 h). Samples which are not 
submitted to the lab in glass must be removed and placed in glass vials 
or aluminum weighing pans before placing them in the drying oven.

          (b) Samples With Organic Interference--Muffle Furnace

    These may include samples with tar as a matrix, vinyl asbestos tile, 
or any other organic that can be reduced by heating. Remove the sample 
from the vial and weigh in a balance to determine the weight of the 
submitted portion. Place the sample in a muffle furnace at 500 [deg]C 
for 1 to 2 h or until all obvious organic material has been removed. 
Retrieve, cool and weigh again to determine the weight loss on ignition. 
This is necessary to determine the asbestos content of the submitted 
sample, because the analyst will be looking at a reduced sample.


[[Page 63]]


    Note: Heating above 600 [deg]C will cause the sample to undergo a 
structural change which, given sufficient time, will convert the 
chrysotile to forsterite. Heating even at lower temperatures for 1 to 2 
h may have a measurable effect on the optical properties of the 
minerals. If the analyst is unsure of what to expect, a sample of 
standard asbestos should be heated to the same temperature for the same 
length of time so that it can be examined for the proper interpretation.

               (c) Samples With Organic Interference--THF

    Vinyl asbestos tile is the most common material treated with this 
solvent, although, substances containing tar will sometimes yield to 
this treatment. Select a portion of the material and then grind it up if 
possible. Weigh the sample and place it in a test tube. Add sufficient 
THF to dissolve the organic matrix. This is usually about 4 to 5 mL. 
Remember, THF is highly flammable. Filter the remaining material through 
a tared silver membrane, dry and weigh to determine how much is left 
after the solvent extraction. Further process the sample to remove 
carbonate or mount directly.

                 (d) Samples With Carbonate Interference

    Carbonate material is often found on fibers and sometimes must be 
removed in order to perform dispersion microscopy. Weigh out a portion 
of the material and place it in a test tube. Add a sufficient amount of 
0.1 M HCl or decalcifying solution in the tube to react all the 
carbonate as evidenced by gas formation; i.e., when the gas bubbles 
stop, add a little more solution. If no more gas forms, the reaction is 
complete. Filter the material out through a tared silver membrane, dry 
and weigh to determine the weight lost.

                         3.4. Sample Preparation

    Samples must be prepared so that accurate determination can be made 
of the asbestos type and amount present. The following steps are carried 
out in the low-flow hood (a low-flow hood has less than 50 fpm flow):
    (1) If the sample has large lumps, is hard, or cannot be made to lie 
under a cover slip, the grain size must be reduced. Place a small amount 
between two slides and grind the material between them or grind a small 
amount in a clean mortar and pestle. The choice of whether to use an 
alumina, ruby, or diamond mortar depends on the hardness of the 
material. Impact damage can alter the asbestos mineral if too much 
mechanical shock occurs. (Freezer mills can completely destroy the 
observable crystallinity of asbestos and should not be used). For some 
samples, a portion of material can be shaved off with a scalpel, ground 
off with a hand grinder or hack saw blade.
    The preparation tools should either be disposable or cleaned 
thoroughly. Use vigorous scrubbing to loosen the fibers during the 
washing. Rinse the implements with copious amounts of water and air-dry 
in a dust-free environment.
    (2) If the sample is powder or has been reduced as in (1) above, it 
is ready to mount. Place a glass slide on a piece of optical tissue and 
write the identification on the painted or frosted end. Place two drops 
of index of refraction medium n=1.550 on the slide. (The medium n=1.550 
is chosen because it is the matching index for chrysotile. Dip the end 
of a clean paper-clip or dissecting needle into the droplet of 
refraction medium on the slide to moisten it. Then dip the probe into 
the powder sample. Transfer what sticks on the probe to the slide. The 
material on the end of the probe should have a diameter of about 3 mm 
for a good mount. If the material is very fine, less sample may be 
appropriate. For non-powder samples such as fiber mats, forceps should 
be used to transfer a small amount of material to the slide. Stir the 
material in the medium on the slide, spreading it out and making the 
preparation as uniform as possible. Place a cover-slip on the 
preparation by gently lowering onto the slide and allowing it to fall 
``trapdoor'' fashion on the preparation to push out any bubbles. Press 
gently on the cover slip to even out the distribution of particulate on 
the slide. If there is insufficient mounting oil on the slide, one or 
two drops may be placed near the edge of the coverslip on the slide. 
Capillary action will draw the necessary amount of liquid into the 
preparation. Remove excess oil with the point of a laboratory wiper.
    Treat at least two different areas of each phase in this fashion. 
Choose representative areas of the sample. It may be useful to select 
particular areas or fibers for analysis. This is useful to identify 
asbestos in severely inhomogeneous samples.
    When it is determined that amphiboles may be present, repeat the 
above process using the appropriate high-dispersion oils until an 
identification is made or all six asbestos minerals have been ruled out. 
Note that percent determination must be done in the index medium 1.550 
because amphiboles tend to disappear in their matching mediums.

                        3.5. Analytical Procedure

    Note: This method presumes some knowledge of mineralogy and optical 
petrography.

    The analysis consists of three parts: The determination of whether 
there is asbestos present, what type is present and the determination of 
how much is present. The general flow of the analysis is:
    (1) Gross examination.

[[Page 64]]

    (2) Examination under polarized light on the stereo microscope.
    (3) Examination by phase-polar illumination on the compound phase 
microscope.
    (4) Determination of species by dispersion stain. Examination by 
Becke line analysis may also be used; however, this is usually more 
cumbersome for asbestos determination.
    (5) Difficult samples may need to be analyzed by SEM or TEM, or the 
results from those techniques combined with light microscopy for a 
definitive identification. Identification of a particle as asbestos 
requires that it be asbestiform. Description of particles should follow 
the suggestion of Campbell. (Figure 1)

[[Page 65]]

[GRAPHIC] [TIFF OMITTED] TR10AU94.007

    For the purpose of regulation, the mineral must be one of the six 
minerals covered and must be in the asbestos growth habit. Large 
specimen samples of asbestos generally have the gross appearance of 
wood. Fibers are easily parted from it. Asbestos fibers are very long 
compared with their widths. The fibers have a very high tensile strength 
as demonstrated by bending without breaking. Asbestos fibers exist in 
bundles that are easily parted, show longitudinal fine structure and may 
be tufted at the ends showing ``bundle of sticks'' morphology. In the 
microscope

[[Page 66]]

some of these properties may not be observable. Amphiboles do not always 
show striations along their length even when they are asbestos. Neither 
will they always show tufting. They generally do not show a curved 
nature except for very long fibers. Asbestos and asbestiform minerals 
are usually characterized in groups by extremely high aspect ratios 
(greater than 100:1). While aspect ratio analysis is useful for 
characterizing populations of fibers, it cannot be used to identify 
individual fibers of intermediate to short aspect ratio. Observation of 
many fibers is often necessary to determine whether a sample consists of 
``cleavage fragments'' or of asbestos fibers.
    Most cleavage fragments of the asbestos minerals are easily 
distinguishable from true asbestos fibers. This is because true cleavage 
fragments usually have larger diameters than 1 [micro]m. Internal 
structure of particles larger than this usually shows them to have no 
internal fibrillar structure. In addition, cleavage fragments of the 
monoclinic amphiboles show inclined extinction under crossed polars with 
no compensator. Asbestos fibers usually show extinction at zero degrees 
or ambiguous extinction if any at all. Morphologically, the larger 
cleavage fragments are obvious by their blunt or stepped ends showing 
prismatic habit. Also, they tend to be acicular rather than filiform.
    Where the particles are less than 1 [micro]m in diameter and have an 
aspect ratio greater than or equal to 3:1, it is recommended that the 
sample be analyzed by SEM or TEM if there is any question whether the 
fibers are cleavage fragments or asbestiform particles.
    Care must be taken when analyzing by electron microscopy because the 
interferences are different from those in light microscopy and may 
structurally be very similar to asbestos. The classic interference is 
between anthophyllite and biopyribole or intermediate fiber. Use the 
same morphological clues for electron microscopy as are used for light 
microscopy, e.g. fibril splitting, internal longitudinal striation, 
fraying, curvature, etc.
    (1) Gross examination:
    Examine the sample, preferably in the glass vial. Determine the 
presence of any obvious fibrous component. Estimate a percentage based 
on previous experience and current observation. Determine whether any 
pre- preparation is necessary. Determine the number of phases present. 
This step may be carried out or augmented by observation at 6 to 40x 
under a stereo microscope.
    (2) After performing any necessary pre-preparation, prepare slides 
of each phase as described above. Two preparations of the same phase in 
the same index medium can be made side-by-side on the same glass for 
convenience. Examine with the polarizing stereo microscope. Estimate the 
percentage of asbestos based on the amount of birefringent fiber 
present.
    (3) Examine the slides on the phase-polar microscopes at 
magnifications of 160 and 400x. Note the morphology of the fibers. Long, 
thin, very straight fibers with little curvature are indicative of 
fibers from the amphibole family. Curved, wavy fibers are usually 
indicative of chrysotile. Estimate the percentage of asbestos on the 
phase-polar microscope under conditions of crossed polars and a gypsum 
plate. Fibers smaller than 1.0 [micro]m in thickness must be identified 
by inference to the presence of larger, identifiable fibers and 
morphology. If no larger fibers are visible, electron microscopy should 
be performed. At this point, only a tentative identification can be 
made. Full identification must be made with dispersion microscopy. 
Details of the tests are included in the appendices.
    (4) Once fibers have been determined to be present, they must be 
identified. Adjust the microscope for dispersion mode and observe the 
fibers. The microscope has a rotating stage, one polarizing element, and 
a system for generating dark-field dispersion microscopy (see Section 
4.6. of this appendix). Align a fiber with its length parallel to the 
polarizer and note the color of the Becke lines. Rotate the stage to 
bring the fiber length perpendicular to the polarizer and note the 
color. Repeat this process for every fiber or fiber bundle examined. The 
colors must be consistent with the colors generated by standard asbestos 
reference materials for a positive identification. In n=1.550, 
amphiboles will generally show a yellow to straw-yellow color indicating 
that the fiber indices of refraction are higher than the liquid. If 
long, thin fibers are noted and the colors are yellow, prepare further 
slides as above in the suggested matching liquids listed below:

------------------------------------------------------------------------
          Type of asbestos                    Index of refraction
------------------------------------------------------------------------
Chrysotile..........................  n=1.550.
Amosite.............................  n=1.670 or 1.680.
Crocidolite.........................  n=1.690.
Anthophyllite.......................  n=1.605 and 1.620.
Tremolite...........................  n=1.605 and 1.620.
Actinolite..........................  n=1.620.
------------------------------------------------------------------------

    Where more than one liquid is suggested, the first is preferred; 
however, in some cases this liquid will not give good dispersion color. 
Take care to avoid interferences in the other liquid; e.g., wollastonite 
in n=1.620 will give the same colors as tremolite. In n=1.605 
wollastonite will appear yellow in all directions. Wollastonite may be 
determined under crossed polars as it will change from blue to yellow as 
it is rotated along its fiber axis by tapping on the cover slip. 
Asbestos minerals will not change in this way.
    Determination of the angle of extinction may, when present, aid in 
the determination

[[Page 67]]

of anthophyllite from tremolite. True asbestos fibers usually have 
0[deg] extinction or ambiguous extinction, while cleavage fragments have 
more definite extinction.
    Continue analysis until both preparations have been examined and all 
present species of asbestos are identified. If there are no fibers 
present, or there is less than 0.1% present, end the analysis with the 
minimum number of slides (2).
    (5) Some fibers have a coating on them which makes dispersion 
microscopy very difficult or impossible. Becke line analysis or electron 
microscopy may be performed in those cases. Determine the percentage by 
light microscopy. TEM analysis tends to overestimate the actual 
percentage present.
    (6) Percentage determination is an estimate of occluded area, 
tempered by gross observation. Gross observation information is used to 
make sure that the high magnification microscopy does not greatly over- 
or under- estimate the amount of fiber present. This part of the 
analysis requires a great deal of experience. Satisfactory models for 
asbestos content analysis have not yet been developed, although some 
models based on metallurgical grain-size determination have found some 
utility. Estimation is more easily handled in situations where the grain 
sizes visible at about 160x are about the same and the sample is 
relatively homogeneous.
    View all of the area under the cover slip to make the percentage 
determination. View the fields while moving the stage, paying attention 
to the clumps of material. These are not usually the best areas to 
perform dispersion microscopy because of the interference from other 
materials. But, they are the areas most likely to represent the accurate 
percentage in the sample. Small amounts of asbestos require slower 
scanning and more frequent analysis of individual fields.
    Report the area occluded by asbestos as the concentration. This 
estimate does not generally take into consideration the difference in 
density of the different species present in the sample. For most samples 
this is adequate. Simulation studies with similar materials must be 
carried out to apply microvisual estimation for that purpose and is 
beyond the scope of this procedure.
    (7) Where successive concentrations have been made by chemical or 
physical means, the amount reported is the percentage of the material in 
the ``as submitted'' or original state. The percentage determined by 
microscopy is multiplied by the fractions remaining after pre-
preparation steps to give the percentage in the original sample. For 
example:

Step 1. 60% remains after heating at 550 [deg]C for 1 h.
Step 2. 30% of the residue of step 1 remains after dissolution of 
carbonate in 0.1 m HCl.
Step 3. Microvisual estimation determines that 5% of the sample is 
chrysotile asbestos.

    The reported result is:

R=(Microvisual result in percent)x(Fraction remaining after step 
2)x(Fraction remaining of original sample after step 1)
R=(5)x(.30)x(.60)=0.9%

    (8) Report the percent and type of asbestos present. For samples 
where asbestos was identified, but is less than 1.0%, report ``Asbestos 
present, less than 1.0%.'' There must have been at least two observed 
fibers or fiber bundles in the two preparations to be reported as 
present. For samples where asbestos was not seen, report as ``None 
Detected.''

                        4. Auxiliary Information

    Because of the subjective nature of asbestos analysis, certain 
concepts and procedures need to be discussed in more depth. This 
information will help the analyst understand why some of the procedures 
are carried out the way they are.

                               4.1. Light

    Light is electromagnetic energy. It travels from its source in 
packets called quanta. It is instructive to consider light as a plane 
wave. The light has a direction of travel. Perpendicular to this and 
mutually perpendicular to each other, are two vector components. One is 
the magnetic vector and the other is the electric vector. We shall only 
be concerned with the electric vector. In this description, the 
interaction of the vector and the mineral will describe all the 
observable phenomena. From a light source such a microscope illuminator, 
light travels in all different direction from the filament.
    In any given direction away from the filament, the electric vector 
is perpendicular to the direction of travel of a light ray. While 
perpendicular, its orientation is random about the travel axis. If the 
electric vectors from all the light rays were lined up by passing the 
light through a filter that would only let light rays with electric 
vectors oriented in one direction pass, the light would then be 
POLARIZED.
    Polarized light interacts with matter in the direction of the 
electric vector. This is the polarization direction. Using this property 
it is possible to use polarized light to probe different materials and 
identify them by how they interact with light.
    The speed of light in a vacuum is a constant at about 2.99x10\8\ m/
s. When light travels in different materials such as air, water, 
minerals or oil, it does not travel at this speed. It travels slower. 
This slowing is a function of both the material through which the light 
is traveling and the wavelength or frequency of the light. In general, 
the more

[[Page 68]]

dense the material, the slower the light travels. Also, generally, the 
higher the frequency, the slower the light will travel. The ratio of the 
speed of light in a vacuum to that in a material is called the index of 
refraction (n). It is usually measured at 589 nm (the sodium D line). If 
white light (light containing all the visible wavelengths) travels 
through a material, rays of longer wavelengths will travel faster than 
those of shorter wavelengths, this separation is called dispersion. 
Dispersion is used as an identifier of materials as described in Section 
4.6.

                        4.2. Material Properties

    Materials are either amorphous or crystalline. The difference 
between these two descriptions depends on the positions of the atoms in 
them. The atoms in amorphous materials are randomly arranged with no 
long range order. An example of an amorphous material is glass. The 
atoms in crystalline materials, on the other hand, are in regular arrays 
and have long range order. Most of the atoms can be found in highly 
predictable locations. Examples of crystalline material are salt, gold, 
and the asbestos minerals.
    It is beyond the scope of this method to describe the different 
types of crystalline materials that can be found, or the full 
description of the classes into which they can fall. However, some 
general crystallography is provided below to give a foundation to the 
procedures described.
    With the exception of anthophyllite, all the asbestos minerals 
belong to the monoclinic crystal type. The unit cell is the basic 
repeating unit of the crystal and for monoclinic crystals can be 
described as having three unequal sides, two 90[deg] angles and one 
angle not equal to 90[deg]. The orthorhombic group, of which 
anthophyllite is a member has three unequal sides and three 90[deg] 
angles. The unequal sides are a consequence of the complexity of fitting 
the different atoms into the unit cell. Although the atoms are in a 
regular array, that array is not symmetrical in all directions. There is 
long range order in the three major directions of the crystal. However, 
the order is different in each of the three directions. This has the 
effect that the index of refraction is different in each of the three 
directions. Using polarized light, we can investigate the index of 
refraction in each of the directions and identify the mineral or 
material under investigation. The indices [alpha], [beta], and [gamma] 
are used to identify the lowest, middle, and highest index of refraction 
respectively. The x direction, associated with [alpha] is called the 
fast axis. Conversely, the z direction is associated with [gamma] and is 
the slow direction. Crocidolite has [alpha] along the fiber length 
making it ``length-fast''. The remainder of the asbestos minerals have 
the [gamma] axis along the fiber length. They are called ``length-
slow''. This orientation to fiber length is used to aid in the 
identification of asbestos.

                     4.3. Polarized Light Technique

    Polarized light microscopy as described in this section uses the 
phase-polar microscope described in Section 3.2. A phase contrast 
microscope is fitted with two polarizing elements, one below and one 
above the sample. The polarizers have their polarization directions at 
right angles to each other. Depending on the tests performed, there may 
be a compensator between these two polarizing elements. Light emerging 
from a polarizing element has its electric vector pointing in the 
polarization direction of the element. The light will not be 
subsequently transmitted through a second element set at a right angle 
to the first element. Unless the light is altered as it passes from one 
element to the other, there is no transmission of light.

                        4.4. Angle of Extinction

    Crystals which have different crystal regularity in two or three 
main directions are said to be anisotropic. They have a different index 
of refraction in each of the main directions. When such a crystal is 
inserted between the crossed polars, the field of view is no longer dark 
but shows the crystal in color. The color depends on the properties of 
the crystal. The light acts as if it travels through the crystal along 
the optical axes. If a crystal optical axis were lined up along one of 
the polarizing directions (either the polarizer or the analyzer) the 
light would appear to travel only in that direction, and it would blink 
out or go dark. The difference in degrees between the fiber direction 
and the angle at which it blinks out is called the angle of extinction. 
When this angle can be measured, it is useful in identifying the 
mineral. The procedure for measuring the angle of extinction is to first 
identify the polarization direction in the microscope. A commercial 
alignment slide can be used to establish the polarization directions or 
use anthophyllite or another suitable mineral. This mineral has a zero 
degree angle of extinction and will go dark to extinction as it aligns 
with the polarization directions. When a fiber of anthophyllite has gone 
to extinction, align the eyepiece reticle or graticule with the fiber so 
that there is a visual cue as to the direction of polarization in the 
field of view. Tape or otherwise secure the eyepiece in this position so 
it will not shift.
    After the polarization direction has been identified in the field of 
view, move the particle of interest to the center of the field of view 
and align it with the polarization direction. For fibers, align the 
fiber along this direction. Note the angular reading of the rotating 
stage. Looking at the particle, rotate the stage until the fiber goes 
dark or ``blinks

[[Page 69]]

out''. Again note the reading of the stage. The difference in the first 
reading and the second is an angle of extinction.
    The angle measured may vary as the orientation of the fiber changes 
about its long axis. Tables of mineralogical data usually report the 
maximum angle of extinction. Asbestos forming minerals, when they 
exhibit an angle of extinction, usually do show an angle of extinction 
close to the reported maximum, or as appropriate depending on the 
substitution chemistry.

                  4.5. Crossed Polars with Compensator

    When the optical axes of a crystal are not lined up along one of the 
polarizing directions (either the polarizer or the analyzer) part of the 
light travels along one axis and part travels along the other visible 
axis. This is characteristic of birefringent materials.
    The color depends on the difference of the two visible indices of 
refraction and the thickness of the crystal. The maximum difference 
available is the difference between the [alpha] and the [gamma] axes. 
This maximum difference is usually tabulated as the birefringence of the 
crystal.
    For this test, align the fiber at 45[deg] to the polarization 
directions in order to maximize the contribution to each of the optical 
axes. The colors seen are called retardation colors. They arise from the 
recombination of light which has traveled through the two separate 
directions of the crystal. One of the rays is retarded behind the other 
since the light in that direction travels slower. On recombination, some 
of the colors which make up white light are enhanced by constructive 
interference and some are suppressed by destructive interference. The 
result is a color dependent on the difference between the indices and 
the thickness of the crystal. The proper colors, thicknesses, and 
retardations are shown on a Michel-Levy chart. The three items, 
retardation, thickness and birefringence are related by the following 
relationship:

R=t(n[gamma]--n[alpha])
R=retardation, t=crystal thickness in [micro]m, and
n[alpha],[gamma]=indices of refraction.

    Examination of the equation for asbestos minerals reveals that the 
visible colors for almost all common asbestos minerals and fiber sizes 
are shades of gray and black. The eye is relatively poor at 
discriminating different shades of gray. It is very good at 
discriminating different colors. In order to compensate for the low 
retardation, a compensator is added to the light train between the 
polarization elements. The compensator used for this test is a gypsum 
plate of known thickness and birefringence. Such a compensator when 
oriented at 45[deg] to the polarizer direction, provides a retardation 
of 530 nm of the 530 nm wavelength color. This enhances the red color 
and gives the background a characteristic red to red-magenta color. If 
this ``full-wave'' compensator is in place when the asbestos preparation 
is inserted into the light train, the colors seen on the fibers are 
quite different. Gypsum, like asbestos has a fast axis and a slow axis. 
When a fiber is aligned with its fast axis in the same direction as the 
fast axis of the gypsum plate, the ray vibrating in the slow direction 
is retarded by both the asbestos and the gypsum. This results in a 
higher retardation than would be present for either of the two minerals. 
The color seen is a second order blue. When the fiber is rotated 90[deg] 
using the rotating stage, the slow direction of the fiber is now aligned 
with the fast direction of the gypsum and the fast direction of the 
fiber is aligned with the slow direction of the gypsum. Thus, one ray 
vibrates faster in the fast direction of the gypsum, and slower in the 
slow direction of the fiber; the other ray will vibrate slower in the 
slow direction of the gypsum and faster in the fast direction of the 
fiber. In this case, the effect is subtractive and the color seen is a 
first order yellow. As long as the fiber thickness does not add 
appreciably to the color, the same basic colors will be seen for all 
asbestos types except crocidolite. In crocidolite the colors will be 
weaker, may be in the opposite directions, and will be altered by the 
blue absorption color natural to crocidolite. Hundreds of other 
materials will give the same colors as asbestos, and therefore, this 
test is not definitive for asbestos. The test is useful in 
discriminating against fiberglass or other amorphous fibers such as some 
synthetic fibers. Certain synthetic fibers will show retardation colors 
different than asbestos; however, there are some forms of polyethylene 
and aramid which will show morphology and retardation colors similar to 
asbestos minerals. This test must be supplemented with a positive 
identification test when birefringent fibers are present which can not 
be excluded by morphology. This test is relatively ineffective for use 
on fibers less than 1 [micro]m in diameter. For positive confirmation 
TEM or SEM should be used if no larger bundles or fibers are visible.

                        4.6. Dispersion Staining

    Dispersion microscopy or dispersion staining is the method of choice 
for the identification of asbestos in bulk materials. Becke line 
analysis is used by some laboratories and yields the same results as 
does dispersion staining for asbestos and can be used in lieu of 
dispersion staining. Dispersion staining is performed on the same 
platform as the phase-polar analysis with the analyzer and compensator 
removed. One polarizing element remains to define the direction of the

[[Page 70]]

light so that the different indices of refraction of the fibers may be 
separately determined. Dispersion microscopy is a dark-field technique 
when used for asbestos. Particles are imaged with scattered light. Light 
which is unscattered is blocked from reaching the eye either by the back 
field image mask in a McCrone objective or a back field image mask in 
the phase condenser. The most convenient method is to use the rotating 
phase condenser to move an oversized phase ring into place. The ideal 
size for this ring is for the central disk to be just larger than the 
objective entry aperture as viewed in the back focal plane. The larger 
the disk, the less scattered light reaches the eye. This will have the 
effect of diminishing the intensity of dispersion color and will shift 
the actual color seen. The colors seen vary even on microscopes from the 
same manufacturer. This is due to the different bands of wavelength 
exclusion by different mask sizes. The mask may either reside in the 
condenser or in the objective back focal plane. It is imperative that 
the analyst determine by experimentation with asbestos standards what 
the appropriate colors should be for each asbestos type. The colors 
depend also on the temperature of the preparation and the exact 
chemistry of the asbestos. Therefore, some slight differences from the 
standards should be allowed. This is not a serious problem for 
commercial asbestos uses. This technique is used for identification of 
the indices of refraction for fibers by recognition of color. There is 
no direct numerical readout of the index of refraction. Correlation of 
color to actual index of refraction is possible by referral to published 
conversion tables. This is not necessary for the analysis of asbestos. 
Recognition of appropriate colors along with the proper morphology are 
deemed sufficient to identify the commercial asbestos minerals. Other 
techniques including SEM, TEM, and XRD may be required to provide 
additional information in order to identify other types of asbestos.
    Make a preparation in the suspected matching high dispersion oil, 
e.g., n=1.550 for chrysotile. Perform the preliminary tests to determine 
whether the fibers are birefringent or not. Take note of the 
morphological character. Wavy fibers are indicative of chrysotile while 
long, straight, thin, frayed fibers are indicative of amphibole 
asbestos. This can aid in the selection of the appropriate matching oil. 
The microscope is set up and the polarization direction is noted as in 
Section 4.4. Align a fiber with the polarization direction. Note the 
color. This is the color parallel to the polarizer. Then rotate the 
fiber rotating the stage 90[deg] so that the polarization direction is 
across the fiber. This is the perpendicular position. Again note the 
color. Both colors must be consistent with standard asbestos minerals in 
the correct direction for a positive identification of asbestos. If only 
one of the colors is correct while the other is not, the identification 
is not positive. If the colors in both directions are bluish-white, the 
analyst has chosen a matching index oil which is higher than the correct 
matching oil, e.g. the analyst has used n=1.620 where chrysotile is 
present. The next lower oil (Section 3.5.) should be used to prepare 
another specimen. If the color in both directions is yellow-white to 
straw-yellow-white, this indicates that the index of the oil is lower 
than the index of the fiber, e.g. the preparation is in n=1.550 while 
anthophyllite is present. Select the next higher oil (Section 3.5.) and 
prepare another slide. Continue in this fashion until a positive 
identification of all asbestos species present has been made or all 
possible asbestos species have been ruled out by negative results in 
this test. Certain plant fibers can have similar dispersion colors as 
asbestos. Take care to note and evaluate the morphology of the fibers or 
remove the plant fibers in pre- preparation. Coating material on the 
fibers such as carbonate or vinyl may destroy the dispersion color. 
Usually, there will be some outcropping of fiber which will show the 
colors sufficient for identification. When this is not the case, treat 
the sample as described in Section 3.3. and then perform dispersion 
staining. Some samples will yield to Becke line analysis if they are 
coated or electron microscopy can be used for identification.

                              5. References

    5.1. Crane, D.T., Asbestos in Air, OSHA method ID160, Revised 
November 1992.
    5.2. Ford, W.E., Dana's Textbook of Mineralogy; Fourth Ed.; John 
Wiley and Son, New York, 1950, p. vii.
    5.3. Selikoff,.I.J., Lee, D.H.K., Asbestos and Disease, Academic 
Press, New York, 1978, pp. 3,20.
    5.4. Women Inspectors of Factories. Annual Report for 1898, H.M. 
Statistical Office, London, p. 170 (1898).
    5.5. Selikoff, I.J., Lee, D.H.K., Asbestos and Disease, Academic 
Press, New York, 1978, pp. 26,30.
    5.6. Campbell, W.J., et al, Selected Silicate Minerals and Their 
Asbestiform Varieties, United States Department of the Interior, Bureau 
of Mines, Information Circular 8751, 1977.
    5.7. Asbestos, Code of Federal Regulations, 29 CFR 1910.1001 and 29 
CFR 1926.58.
    5.8. National Emission Standards for Hazardous Air Pollutants; 
Asbestos NESHAP Revision, Federal Register, Vol. 55, No. 224, 20 
November 1990, p. 48410.
    5.9. Ross, M. The Asbestos Minerals: Definitions, Description, Modes 
of Formation, Physical and Chemical Properties and Health Risk to the 
Mining Community, Nation Bureau of Standards Special Publication, 
Washington, DC, 1977.

[[Page 71]]

    5.10. Lilis, R., Fibrous Zeolites and Endemic Mesothelioma in 
Cappadocia, Turkey, J. Occ Medicine, 1981, 23,(8),548-550.
    5.11. Occupational Exposure to Asbestos--1972, U.S. Department of 
Health, Education and Welfare, Public Health Service, Center for Disease 
Control, National Institute for Occupational Safety and Health, HSM-72-
10267.
    5.12. Campbell, W.J., et al, Relationship of Mineral Habit to Size 
Characteristics for Tremolite Fragments and Fibers, United States 
Department of the Interior, Bureau of Mines, Information Circular 8367, 
1979.
    5.13. Mefford, D., DCM Laboratory, Denver, private communication, 
July 1987.
    5.14. Deer, W.A., Howie, R.A., Zussman, J., Rock Forming Minerals, 
Longman, Thetford, UK, 1974.
    5.15. Kerr, P.F., Optical Mineralogy; Third Ed. McGraw-Hill, New 
York, 1959.
    5.16. Veblen, D.R. (Ed.), Amphiboles and Other Hydrous Pyriboles--
Mineralogy, Reviews in Mineralogy, Vol 9A, Michigan, 1982, pp 1-102.
    5.17. Dixon, W.C., Applications of Optical Microscopy in the 
Analysis of Asbestos and Quartz, ACS Symposium Series, No. 120, 
Analytical Techniques in Occupational Health Chemistry, 1979.
    5.18. Polarized Light Microscopy, McCrone Research Institute, 
Chicago, 1976.
    5.19. Asbestos Identification, McCrone Research Institute, G & G 
printers, Chicago, 1987.
    5.20. McCrone, W.C., Calculation of Refractive Indices from 
Dispersion Staining Data, The Microscope, No 37, Chicago, 1989.
    5.21. Levadie, B. (Ed.), Asbestos and Other Health Related 
Silicates, ASTM Technical Publication 834, ASTM, Philadelphia 1982.
    5.22. Steel, E. and Wylie, A., Riordan, P.H. (Ed.), Mineralogical 
Characteristics of Asbestos, Geology of Asbestos Deposits, pp. 93-101, 
SME-AIME, 1981.
    5.23. Zussman, J., The Mineralogy of Asbestos, Asbestos: Properties, 
Applications and Hazards, pp. 45-67 Wiley, 1979.

[51 FR 22733, June 20, 1986, as amended at 51 FR 37004, Oct. 17, 1986; 
52 FR 17754, 17755, May 12, 1987; 53 FR 35625, September 14, 1988; 54 FR 
24334, June 7, 1989; 54 FR 29546, July 13, 1989; 54 FR 52027, Dec. 20, 
1989, 55 FR 3731, Feb. 5, 1990; 55 FR 34710, Aug. 24, 1990; 57 FR 24330, 
June 8, 1992; 59 FR 41057, Aug. 10, 1994; 60 FR 9625, Feb. 21, 1995; 60 
FR 33344, June 28, 1995; 60 FR 33984-33987, June 29, 1995; 61 FR 5508, 
Feb. 13, 1996; 61 FR 43457, Aug. 23, 1996; 63 FR 1285, Jan. 8, 1998; 70 
FR 1141, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50188, 
Aug. 24, 2006; 73 FR 75584, Dec. 12, 2008]



Sec. 1910.1002  Coal tar pitch volatiles; interpretation of term.

    As used in Sec. 1910.1000 (Table Z-1), coal tar pitch volatiles 
include the fused polycyclic hydrocarbons which volatilize from the 
distillation residues of coal, petroleum (excluding asphalt), wood, and 
other organic matter. Asphalt (CAS 8052-42-4, and CAS 64742-93-4) is not 
covered under the ``coal tar pitch volatiles'' standard.

[48 FR 2768, Jan. 21, 1983]



Sec. 1910.1003  13 Carcinogens (4-Nitrobiphenyl, etc.).

    (a) Scope and application. (1) This section applies to any area in 
which the 13 carcinogens addressed by this section are manufactured, 
processed, repackaged, released, handled, or stored, but shall not apply 
to transshipment in sealed containers, except for the labeling 
requirements under paragraphs (e)(2), (3) and (4) of this section. The 
13 carcinogens are the following:

4-Nitrobiphenyl, Chemical Abstracts Service Register Number (CAS No.) 
92933;
alpha-Naphthylamine, CAS No. 134327;
methyl chloromethyl ether, CAS No. 107302;
3,'-Dichlorobenzidine (and its salts) CAS No. 91941;
bis-Chloromethyl ether, CAS No. 542881;
beta-Naphthylamine, CAS No. 91598;
Benzidine, CAS No. 92875;
4-Aminodiphenyl, CAS No. 92671;
Ethyleneimine, CAS No. 151564;
beta-Propiolactone, CAS No. 57578;
2-Acetylaminofluorene, CAS No. 53963;
4-Dimethylaminoazo-benezene, CAS No. 60117; and
N-Nitrosodimethylamine, CAS No. 62759.

    (2) This section shall not apply to the following:
    (i) Solid or liquid mixtures containing less than 0.1 percent by 
weight or volume of 4-Nitrobiphenyl; methyl chloromethyl ether; bis-
chloromethyl ether; beta-Naphthylamine; benzidine or 4-Aminodiphenyl; 
and
    (ii) Solid or liquid mixtures containing less than 1.0 percent by 
weight or volume of alpha-Naphthylamine; 3,'-Dichlorobenzidine (and its 
salts); Ethyleneimine; beta-Propiolactone; 2-Acetylaminofluorene; 4-
Dimethylaminoazobenzene, or N-Nitrosodimethylamine.
    (b) Definitions. For the purposes of this section:
    Absolute filter is one capable of retaining 99.97 percent of a mono 
disperse aerosol of 0.3 [micro]m particles.
    Authorized employee means an employee whose duties require him to be

[[Page 72]]

in the regulated area and who has been specifically assigned by the 
employer.
    Clean change room means a room where employees put on clean clothing 
and/or protective equipment in an environment free of the 13 carcinogens 
addressed by this section. The clean change room shall be contiguous to 
and have an entry from a shower room, when the shower room facilities 
are otherwise required in this section.
    Closed system means an operation involving a carcinogen addressed by 
this section where containment prevents the release of the material into 
regulated areas, non-regulated areas, or the external environment.
    Decontamination means the inactivation of a carcinogen addressed by 
this section or its safe disposal.
    Director means the Director, National Institute for Occupational 
Safety and Health, or any person directed by him or the Secretary of 
Health and Human Services to act for the Director.
    Disposal means the safe removal of the carcinogens addressed by this 
section from the work environment.
    Emergency means an unforeseen circumstance or set of circumstances 
resulting in the release of a carcinogen addressed by this section that 
may result in exposure to or contact with the material.
    External environment means any environment external to regulated and 
nonregulated areas.
    Isolated system means a fully enclosed structure other than the 
vessel of containment of a carcinogen addressed by this section that is 
impervious to the passage of the material and would prevent the entry of 
the carcinogen addressed by this section into regulated areas, 
nonregulated areas, or the external environment, should leakage or 
spillage from the vessel of containment occur.
    Laboratory-type hood is a device enclosed on the three sides and the 
top and bottom, designed and maintained so as to draw air inward at an 
average linear face velocity of 150 feet per minute with a minimum of 
125 feet per minute; designed, constructed, and maintained in such a way 
that an operation involving a carcinogen addressed by this section 
within the hood does not require the insertion of any portion of any 
employee's body other than his hands and arms.
    Nonregulated area means any area under the control of the employer 
where entry and exit is neither restricted nor controlled.
    Open-vessel system means an operation involving a carcinogen 
addressed by this section in an open vessel that is not in an isolated 
system, a laboratory-type hood, nor in any other system affording 
equivalent protection against the entry of the material into regulated 
areas, non-regulated areas, or the external environment.
    Protective clothing means clothing designed to protect an employee 
against contact with or exposure to a carcinogen addressed by this 
section.
    Regulated area means an area where entry and exit is restricted and 
controlled.
    (c) Requirements for areas containing a carcinogen addressed by this 
section. A regulated area shall be established by an employer where a 
carcinogen addressed by this section is manufactured, processed, used, 
repackaged, released, handled or stored. All such areas shall be 
controlled in accordance with the requirements for the following 
category or categories describing the operation involved:
    (1) Isolated systems. Employees working with a carcinogen addressed 
by this section within an isolated system such as a ``glove box'' shall 
wash their hands and arms upon completion of the assigned task and 
before engaging in other activities not associated with the isolated 
system.
    (2) Closed system operation. (i) Within regulated areas where the 
carcinogens addressed by this section are stored in sealed containers, 
or contained in a closed system, including piping systems, with any 
sample ports or openings closed while the carcinogens addressed by this 
section are contained within, access shall be restricted to authorized 
employees only.
    (ii) Employees exposed to 4-Nitrobiphenyl; alpha-Naphthylamine; 3,'-
Dichlorobenzidine (and its salts); beta-Naphthylamine; benzidine; 4-
Aminodiphenyl; 2-Acetylaminofluorene; 4-Dimethylaminoazo-benzene; and N-

[[Page 73]]

Nitrosodimethylamine shall be required to wash hands, forearms, face, 
and neck upon each exit from the regulated areas, close to the point of 
exit, and before engaging in other activities.
    (3) Open-vessel system operations. Open-vessel system operations as 
defined in paragraph (b)(13) of this section are prohibited.
    (4) Transfer from a closed system, charging or discharging point 
operations, or otherwise opening a closed system. In operations 
involving ``laboratory-type hoods,'' or in locations where the 
carcinogens addressed by this section are contained in an otherwise 
``closed system,'' but is transferred, charged, or discharged into other 
normally closed containers, the provisions of this paragraph shall 
apply.
    (i) Access shall be restricted to authorized employees only.
    (ii) Each operation shall be provided with continuous local exhaust 
ventilation so that air movement is always from ordinary work areas to 
the operation. Exhaust air shall not be discharged to regulated areas, 
nonregulated areas or the external environment unless decontaminated. 
Clean makeup air shall be introduced in sufficient volume to maintain 
the correct operation of the local exhaust system.
    (iii) Employees shall be provided with, and required to wear, clean, 
full body protective clothing (smocks, coveralls, or long-sleeved shirt 
and pants), shoe covers and gloves prior to entering the regulated area.
    (iv) Each employee engaged in handling operations involving the 
carcinogens addressed by this section must be provided with, and 
required to wear and use, a half-face filter type respirator for dusts, 
mists, and fumes. A respirator affording higher levels of protection 
than this respirator may be substituted.
    (v) Prior to each exit from a regulated area, employees shall be 
required to remove and leave protective clothing and equipment at the 
point of exit and at the last exit of the day, to place used clothing 
and equipment in impervious containers at the point of exit for purposes 
of decontamination or disposal. The contents of such impervious 
containers shall be identified, as required under paragraphs (e) (2), 
(3), and (4) of this section.
    (vi) Drinking fountains are prohibited in the regulated area.
    (vii) Employees shall be required to wash hands, forearms, face, and 
neck on each exit from the regulated area, close to the point of exit, 
and before engaging in other activities and employees exposed to 4-
Nitrobiphenyl; alpha-Naphthylamine; 3,'-Dichlorobenzidine (and its 
salts); beta-Naphthylamine; Benzidine; 4-Aminodiphenyl; 2-
Acetylaminofluorene; 4-Dimethylaminoazo-benzene; and N-
Nitrosodimethylamine shall be required to shower after the last exit of 
the day.
    (5) Maintenance and decontamination activities. In cleanup of leaks 
of spills, maintenance, or repair operations on contaminated systems or 
equipment, or any operations involving work in an area where direct 
contact with a carcinogen addressed by this section could result, each 
authorized employee entering that area shall:
    (i) Be provided with and required to wear clean, impervious 
garments, including gloves, boots, and continuous-air supplied hood in 
accordance with Sec. 1910.134;
    (ii) Be decontaminated before removing the protective garments and 
hood;
    (iii) Be required to shower upon removing the protective garments 
and hood.
    (d) General regulated area requirements--(1) Respiratory program. 
The employer must implement a respiratory protection program in 
accordance with Sec. 1910.134 (b), (c), (d) (except (d)(1)(iii) and 
(iv), and (d)(3)), and (e) through (m), which covers each employee 
required by this section to use a respirator.
    (2) Emergencies. In an emergency, immediate measures including, but 
not limited to, the requirements of paragraphs (d)(2) (i) through (v) of 
this section shall be implemented.
    (i) The potentially affected area shall be evacuated as soon as the 
emergency has been determined.
    (ii) Hazardous conditions created by the emergency shall be 
eliminated and the potentially affected area shall be

[[Page 74]]

decontaminated prior to the resumption of normal operations.
    (iii) Special medical surveillance by a physician shall be 
instituted within 24 hours for employees present in the potentially 
affected area at the time of the emergency. A report of the medical 
surveillance and any treatment shall be included in the incident report, 
in accordance with paragraph (f)(2) of this section.
    (iv) Where an employee has a known contact with a carcinogen 
addressed by this section, such employee shall be required to shower as 
soon as possible, unless contraindicated by physical injuries.
    (v) An incident report on the emergency shall be reported as 
provided in paragraph (f)(2) of this section.
    (vi) Emergency deluge showers and eyewash fountains supplied with 
running potable water shall be located near, within sight of, and on the 
same level with locations where a direct exposure to Ethyleneimine or 
beta-Propiolactone only would be most likely as a result of equipment 
failure or improper work practice.
    (3) Hygiene facilities and practices. (i) Storage or consumption of 
food, storage or use of containers of beverages, storage or application 
of cosmetics, smoking, storage of smoking materials, tobacco products or 
other products for chewing, or the chewing of such products are 
prohibited in regulated areas.
    (ii) Where employees are required by this section to wash, washing 
facilities shall be provided in accordance with Sec. 1910.141(d) (1) 
and (2) (ii) through (vii).
    (iii) Where employees are required by this section to shower, shower 
facilities shall be provided in accordance with Sec. 1910.141(d)(3).
    (iv) Where employees wear protective clothing and equipment, clean 
change rooms shall be provided for the number of such employees required 
to change clothes, in accordance with Sec. 1910.141(e).
    (v) Where toilets are in regulated areas, such toilets shall be in a 
separate room.
    (4) Contamination control. (i) Except for outdoor systems, regulated 
areas shall be maintained under pressure negative with respect to 
nonregulated areas. Local exhaust ventilation may be used to satisfy 
this requirement. Clean makeup air in equal volume shall replace air 
removed.
    (ii) Any equipment, material, or other item taken into or removed 
from a regulated area shall be done so in a manner that does not cause 
contamination in nonregulated areas or the external environment.
    (iii) Decontamination procedures shall be established and 
implemented to remove carcinogens addressed by this section from the 
surfaces of materials, equipment, and the decontamination facility.
    (iv) Dry sweeping and dry mopping are prohibited for 4-
Nitrobiphenyl; alpha-Naphthylamine; 3,'-Dichlorobenzidine (and its 
salts); beta-Naphthylamine; Benzidine; 4-Aminodiphenyl; 2-
Acetylaminofluorene; 4-Dimethylaminoazo-benzene and N-
Nitrosodimethylamine.
    (e) Signs, information and training--(1) Signs--(i) Entrances to 
regulated areas shall be posted with signs bearing the legend:

                          CANCER-SUSPECT AGENT

                        AUTHORIZED PERSONNEL ONLY

    (ii) Entrances to regulated areas containing operations covered in 
paragraph (c)(5) of this section shall be posted with signs bearing the 
legend:

                CANCER-SUSPECT AGENT EXPOSED IN THIS AREA

IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD REQUIRED 
                              AT ALL TIMES

                        AUTHORIZED PERSONNEL ONLY

    (iii) Appropriate signs and instructions shall be posted at the 
entrance to, and exit from, regulated areas, informing employees of the 
procedures that must be followed in entering and leaving a regulated 
area.
    (2) Container contents identification. (i) Containers of a 
carcinogen addressed by this section and containers required under 
paragraphs (c)(4)(v) and (c)(6) (vii)(B) and (viii)(B) of this section 
that are accessible only to and handled only by authorized employees, or 
by other employees trained in accordance with paragraph (e)(5) of this 
section, may have contents identification limited to a generic or 
proprietary name or other

[[Page 75]]

proprietary identification of the carcinogen and percent.
    (ii) Containers of a carcinogen addressed by this section and 
containers required under paragraphs (c)(4)(v) and (c)(6) (vii)(B) and 
(viii)(B) of this section that are accessible to or handled by employees 
other than authorized employees or employees trained in accordance with 
paragraph (e)(5) of this section shall have contents identification that 
includes the full chemical name and Chemical Abstracts Service Registry 
number as listed in paragraph (a)(1) of this section.
    (iii) Containers shall have the warning words ``CANCER-SUSPECT 
AGENT'' displayed immediately under or adjacent to the contents 
identification.
    (iv) Containers whose contents are carcinogens addressed by this 
section with corrosive or irritating properties shall have label 
statements warning of such hazards noting, if appropriate, particularly 
sensitive or affected portions of the body.
    (3) Lettering. Lettering on signs and instructions required by 
paragraph (e)(1) shall be a minimum letter height of 2 inches (5 cm). 
Labels on containers required under this section shall not be less than 
one-half the size of the largest lettering on the package, and not less 
than 8-point type in any instance. Provided, That no such required 
lettering need be more than 1 inch (2.5 cm) in height.
    (4) Prohibited statements. No statement shall appear on or near any 
required sign, label, or instruction that contradicts or detracts from 
the effect of any required warning, information, or instruction.
    (5) Training and indoctrination. (i) Each employee prior to being 
authorized to enter a regulated area, shall receive a training and 
indoctrination program including, but not necessarily limited to:
    (A) The nature of the carcinogenic hazards of a carcinogen addressed 
by this section, including local and systemic toxicity;
    (B) The specific nature of the operation involving a carcinogen 
addressed by this section that could result in exposure;
    (C) The purpose for and application of the medical surveillance 
program, including, as appropriate, methods of self-examination;
    (D) The purpose for and application of decontamination practices and 
purposes;
    (E) The purpose for and significance of emergency practices and 
procedures;
    (F) The employee's specific role in emergency procedures;
    (G) Specific information to aid the employee in recognition and 
evaluation of conditions and situations which may result in the release 
of a carcinogen addressed by this section;
    (H) The purpose for and application of specific first aid procedures 
and practices;
    (I) A review of this section at the employee's first training and 
indoctrination program and annually thereafter.
    (ii) Specific emergency procedures shall be prescribed, and posted, 
and employees shall be familiarized with their terms, and rehearsed in 
their application.
    (iii) All materials relating to the program shall be provided upon 
request to authorized representatives of the Assistant Secretary and the 
Director.
    (f) [Reserved]
    (g) Medical surveillance. At no cost to the employee, a program of 
medical surveillance shall be established and implemented for employees 
considered for assignment to enter regulated areas, and for authorized 
employees.
    (1) Examinations. (i) Before an employee is assigned to enter a 
regulated area, a preassignment physical examination by a physician 
shall be provided. The examination shall include the personal history of 
the employee, family and occupational background, including genetic and 
environmental factors.
    (ii) Authorized employees shall be provided periodic physical 
examinations, not less often than annually, following the preassignment 
examination.
    (iii) In all physical examinations, the examining physician shall 
consider whether there exist conditions of increased risk, including 
reduced immunological competence, those undergoing treatment with 
steroids or cytotoxic agents, pregnancy, and cigarette smoking.

[[Page 76]]

    (2) Records. (i) Employers of employees examined pursuant to this 
paragraph shall cause to be maintained complete and accurate records of 
all such medical examinations. Records shall be maintained for the 
duration of the employee's employment. Upon termination of the 
employee's employment, including retirement or death, or in the event 
that the employer ceases business without a successor, records, or 
notarized true copies thereof, shall be forwarded by registered mail to 
the Director.
    (ii) Records required by this paragraph shall be provided upon 
request to employees, designated representatives, and the Assistant 
Secretary in accordance with 29 CFR 1910.1020 (a) through (e) and (g) 
through (i). These records shall also be provided upon request to the 
Director.
    (iii) Any physician who conducts a medical examination required by 
this paragraph shall furnish to the employer a statement of the 
employee's suitability for employment in the specific exposure.

[61 FR 9242, Mar. 7, 1996, as amended at 63 FR 1286, Jan. 8, 1998; 63 FR 
20099, Apr. 23, 1998; 70 FR 1141, Jan. 5, 2005; 71 FR 16672, Apr. 3, 
2006; 73 FR 75584, Dec. 2, 2008]



Sec. 1910.1004  alpha-Naphthylamine.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1005  [Reserved]



Sec. 1910.1006  Methyl chloromethyl ether.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1007  3,'-Dichlorobenzidine (and its salts).

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1008  bis-Chloromethyl ether.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1009  beta-Naphthylamine.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1010  Benzidine.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1011  4-Aminodiphenyl.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1012  Ethyleneimine.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1013  beta-Propiolactone.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1014  2-Acetylaminofluorene.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1015  4-Dimethylaminoazobenzene.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1016  N-Nitrosodimethylamine.

    See Sec. 1910.1003, 13 carcinogens.

[61 FR 9245, Mar. 7, 1996]



Sec. 1910.1017  Vinyl chloride.

    (a) Scope and application. (1) This section includes requirements 
for the control of employee exposure to vinyl chloride (chloroethene), 
Chemical Abstracts Service Registry No. 75014.
    (2) This section applies to the manufacture, reaction, packaging, 
repackaging, storage, handling or use of vinyl chloride or polyvinyl 
chloride, but does not apply to the handling or use of fabricated 
products made of polyvinyl chloride.
    (3) This section applies to the transportation of vinyl chloride or 
polyvinyl chloride except to the extent that the Department of 
Transportation may regulate the hazards covered by this section.
    (b) Definitions. (1) Action level means a concentration of vinyl 
chloride of 0.5 ppm averaged over an 8-hour work day.
    (2) Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or his 
designee.

[[Page 77]]

    (3) Authorized person means any person specifically authorized by 
the employer whose duties require him to enter a regulated area or any 
person entering such an area as a designated representative of employees 
for the purpose of exercising an opportunity to observe monitoring and 
measuring procedures.
    (4) Director means the Director, National Institute for Occupational 
Safety and Health, U.S. Department of Health and Human Services, or his 
designee.
    (5) Emergency means any occurrence such as, but not limited to, 
equipment failure, or operation of a relief device which is likely to, 
or does, result in massive release of vinyl chloride.
    (6) Fabricated product means a product made wholly or partly from 
polyvinyl chloride, and which does not require further processing at 
temperatures, and for times, sufficient to cause mass melting of the 
polyvinyl chloride resulting in the release of vinyl chloride.
    (7) Hazardous operation means any operation, procedure, or activity 
where a release of either vinyl chloride liquid or gas might be expected 
as a consequence of the operation or because of an accident in the 
operation, which would result in an employee exposure in excess of the 
permissible exposure limit.
    (8) OSHA Area Director means the Director for the Occupational 
Safety and Health Administration Area Office having jurisdiction over 
the geographic area in which the employer's establishment is located.
    (9) Polyvinyl chloride means polyvinyl chloride homopolymer or 
copolymer before such is converted to a fabricated product.
    (10) Vinyl chloride means vinyl chloride monomer.
    (c) Permissible exposure limit. (1) No employee may be exposed to 
vinyl chloride at concentrations greater than 1 ppm averaged over any 8-
hour period, and
    (2) No employee may be exposed to vinyl chloride at concentrations 
greater than 5 ppm averaged over any period not exceeding 15 minutes.
    (3) No employee may be exposed to vinyl chloride by direct contact 
with liquid vinyl chloride.
    (d) Monitoring. (1) A program of initial monitoring and measurement 
shall be undertaken in each establishment to determine if there is any 
employee exposed, without regard to the use of respirators, in excess of 
the action level.
    (2) Where a determination conducted under paragraph (d)(1) of this 
section shows any employee exposures, without regard to the use of 
respirators, in excess of the action level, a program for determining 
exposures for each such employee shall be established. Such a program:
    (i) Must be repeated at least quarterly for any employee exposed, 
without regard to the use of respirators, in excess of the permissible 
exposure limit.
    (ii) Must be repeated not less than every 6 months for any employee 
exposed without regard to the use of respirators, at or above the action 
level.
    (iii) May be discontinued for any employee only when at least two 
consecutive monitoring determinations, made not less than 5 working days 
apart, show exposures for that employee at or below the action level.
    (3) Whenever there has been a production, process or control change 
which may result in an increase in the release of vinyl chloride, or the 
employer has any other reason to suspect that any employee may be 
exposed in excess of the action level, a determination of employee 
exposure under paragraph (d)(1) of this section shall be performed.
    (4) The method of monitoring and measurement shall have an accuracy 
(with a confidence level of 95 percent) of not less than plus or minus 
50 percent from 0.25 through 0.5 ppm, plus or minus 35 percent from over 
0.5 ppm through 1.0 ppm, and plus or minus 25 percent over 1.0 ppm. 
(Methods meeting these accuracy requirements are available in the 
``NIOSH Manual of Analytical Methods'').
    (5) Employees or their designated representatives shall be afforded 
reasonable opportunity to observe the monitoring and measuring required 
by this paragraph.

[[Page 78]]

    (e) Regulated area. (1) A regulated area shall be established where:
    (i) Vinyl chloride or polyvinyl chloride is manufactured, reacted, 
repackaged, stored, handled or used; and
    (ii) Vinyl chloride concentrations are in excess of the permissible 
exposure limit.
    (2) Access to regulated areas shall be limited to authorized 
persons.
    (f) Methods of compliance. Employee exposures to vinyl chloride 
shall be controlled to at or below the permissible exposure limit 
provided in paragraph (c) of this section by engineering, work practice, 
and personal protective controls as follows:
    (1) Feasible engineering and work practice controls shall 
immediately be used to reduce exposures to at or below the permissible 
exposure limit.
    (2) Wherever feasible engineering and work practice controls which 
can be instituted immediately are not sufficient to reduce exposures to 
at or below the permissible exposure limit, they shall nonetheless be 
used to reduce exposures to the lowest practicable level, and shall be 
supplemented by respiratory protection in accordance with paragraph (g) 
of this section. A program shall be established and implemented to 
reduce exposures to at or below the permissible exposure limit, or to 
the greatest extent feasible, solely by means of engineering and work 
practice controls, as soon as feasible.
    (3) Written plans for such a program shall be developed and 
furnished upon request for examination and copying to authorized 
representatives of the Assistant Secretary and the Director. Such plans 
must be updated at least annually.
    (g) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer must provide each 
employee an appropriate respirator that complies with the requirements 
of this paragraph.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance Sec. 1910.134 (b) through (d) (except 
(d)(1)(iii), and (d)(3)(iii)(B)(1) and (2)), and (f) through (m) which 
covers each employee required by this section to use a respirator.
    (3) Respirator selection. (i) Employers must:
    (A) Select, and provide to employees, the appropriate respirators 
specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134.
    (B) Provide an organic vapor cartridge that has a service life of at 
least one hour when using a chemical cartridge respirator at vinyl 
chloride concentrations up to 10 ppm.
    (C) Select a canister that has a service life of at least four hours 
when using a powered air-purifying respirator having a hood, helmet, or 
full or half facepiece, or a gas mask with a front-or back-mounted 
canister, at vinyl chloride concentrations up to 25 ppm.
    (ii) When air-purifying respirators are used:
    (A) Air-purifying canisters or cartridges must be replaced prior to 
the expiration of their service life or the end of the shift in which 
they are first used, whichever occurs first.
    (B) A continuous-monitoring and alarm system must be provided when 
concentrations of vinyl chloride could reasonably exceed the allowable 
concentrations for the devices in use. Such a system must be used to 
alert employees when vinyl chloride concentrations exceed the allowable 
concentrations for the devices in use.
    (h) Hazardous operations. (1) Employees engaged in hazardous 
operations, including entry of vessels to clean polyvinyl chloride 
residue from vessel walls, shall be provided and required to wear and 
use;
    (i) Respiratory protection in accordance with paragraphs (c) and (g) 
of this section; and
    (ii) Protective garments to prevent skin contact with liquid vinyl 
chloride or with polyvinyl chloride residue from vessel walls. The 
protective garments shall be selected for the operation and its possible 
exposure conditions.
    (2) Protective garments shall be provided clean and dry for each 
use.
    (i) Emergency situations. A written operational plan for emergency 
situations shall be developed for each facility storing, handling, or 
otherwise using vinyl chloride as a liquid or compressed gas. 
Appropriate portions of the plan shall be implemented in the

[[Page 79]]

event of an emergency. The plan shall specifically provide that:
    (1) Employees engaged in hazardous operations or correcting 
situations of existing hazardous releases shall be equipped as required 
in paragraph (h) of this section;
    (2) Other employees not so equipped shall evacuate the area and not 
return until conditions are controlled by the methods required in 
paragraph (f) of this section and the emergency is abated.
    (j) Training. Each employee engaged in vinyl chloride or polyvinyl 
chloride operations shall be provided training in a program relating to 
the hazards of vinyl chloride and precautions for its safe use.
    (1) The program shall include:
    (i) The nature of the health hazard from chronic exposure to vinyl 
chloride including specifically the carcinogenic hazard;
    (ii) The specific nature of operations which could result in 
exposure to vinyl chloride in excess of the permissible limit and 
necessary protective steps;
    (iii) The purpose for, proper use, and limitations of respiratory 
protective devices;
    (iv) The fire hazard and acute toxicity of vinyl chloride, and the 
necessary protective steps;
    (v) The purpose for and a description of the monitoring program;
    (vi) The purpose for, and a description of, the medical surveillance 
program;
    (vii) Emergency procedures;
    (viii) Specific information to aid the employee in recognition of 
conditions which may result in the release of vinyl chloride; and
    (ix) A review of this standard at the employee's first training and 
indoctrination program, and annually thereafter.
    (2) All materials relating to the program shall be provided upon 
request to the Assistant Secretary and the Director.
    (k) Medical surveillance. A program of medical surveillance shall be 
instituted for each employee exposed, without regard to the use of 
respirators, to vinyl chloride in excess of the action level. The 
program shall provide each such employee with an opportunity for 
examinations and tests in accordance with this paragraph. All medical 
examinations and procedures shall be performed by or under the 
supervision of a licensed physician, and shall be provided without cost 
to the employee.
    (1) At the time of initial assignment, or upon institution of 
medical surveillance;
    (i) A general physical examination shall be performed, with specific 
attention to detecting enlargement of liver, spleen or kidneys, or 
dysfunction in these organs, and for abnormalities in skin, connective 
tissues and the pulmonary system (See Appendix A).
    (ii) A medical history shall be taken, including the following 
topics:
    (A) Alcohol intake;
    (B) Past history of hepatitis;
    (C) Work history and past exposure to potential hepatotoxic agents, 
including drugs and chemicals;
    (D) Past history of blood transfusions; and
    (E) Past history of hospitalizations.
    (iii) A serum specimen shall be obtained and determinations made of:
    (A) Total bilirubin;
    (B) Alkaline phosphatase;
    (C) Serum glutamic oxalacetic transaminase (SGOT);
    (D) Serum glutamic pyruvic transaminase (SGPT); and
    (E) Gamma glustamyl transpeptidase.
    (2) Examinations must be provided in accordance with this paragraph 
at least annually.
    (3) Each employee exposed to an emergency shall be afforded 
appropriate medical surveillance.
    (4) A statement of each employee's suitability for continued 
exposure to vinyl chloride including use of protective equipment and 
respirators, shall be obtained from the examining physician promptly 
after any examination. A copy of the physician's statement shall be 
provided each employee.
    (5) If any employee's health would be materially impaired by 
continued exposure, such employee shall be withdrawn from possible 
contact with vinyl chloride.
    (6) Laboratory analyses for all biological specimens included in 
medical examination shall be performed by accredited laboratories.

[[Page 80]]

    (7) If the examining physician determines that alternative medical 
examinations to those required by paragraph (k)(1) of this section will 
provide at least equal assurance of detecting medical conditions 
pertinent to the exposure to vinyl chloride, the employer may accept 
such alternative examinations as meeting the requirements of paragraph 
(k)(1) of this section, if the employer obtains a statement from the 
examining physician setting forth the alternative examinations and the 
rationale for substitution. This statement shall be available upon 
request for examination and copying to authorized representatives of the 
Assistant Secretary and the Director.
    (l) Signs and labels. (1) Entrances to regulated areas shall be 
posted with legible signs bearing the legend:

           Cancer-Suspect Agent Area Authorized Personnel Only

    (2) Areas containing hazardous operations or where an emergency 
currently exists shall be posted with legible signs bearing the legend:

    Cancer-Suspect Agent in This Area Protective Equipment Required 
                        Authorized Personnel Only

    (3) Containers of polyvinyl chloride resin waste from reactors or 
other waste contaminated with vinyl chloride shall be legibly labeled:

                    Contaminated With Vinyl Chloride

                          Cancer-Suspect Agent

    (4) Containers of polyvinyl chloride shall be legibly labeled:

                   Polyvinyl Chloride (or Trade Name)

                                Contains

                             Vinyl Chloride

                Vinyl Chloride is a Cancer-Suspect Agent

    (5) Containers of vinyl chloride shall be legibly labeled either:
    (i)

                             Vinyl Chloride

                 Extremely Flammable Gas Under Pressure

                          Cancer Suspect Agent

    or (ii) In accordance with 49 CFR Parts 170 through 189, with the 
additional legend:

                          Cancer-Suspect Agent

applied near the label or placard.
    (6) No statement shall appear on or near any required sign, label or 
instruction which contradicts or detracts from the effect of, any 
required warning, information or instruction.
    (m) Records. (1) All records maintained in accordance with this 
section shall include the name and social security number of each 
employee where relevant.
    (2) Records of required monitoring and measuring and medical records 
shall be provided upon request to employees, designated representatives, 
and the Assistant Secretary in accordance with 29 CFR 1910.1020 (a) 
through (e) and (g) through (i). These records shall be provided upon 
request to the Director. Authorized personnel rosters shall also be 
provided upon request to the Assistant Secretary and the Director.
    (i) Monitoring and measuring records shall:
    (A) State the date of such monitoring and measuring and the 
concentrations determined and identify the instruments and methods used;
    (B) Include any additional information necessary to determine 
individual employee exposures where such exposures are determined by 
means other than individual monitoring of employees; and
    (C) Be maintained for not less than 30 years.
    (ii) [Reserved]
    (iii) Medical records shall be maintained for the duration of the 
employment of each employee plus 20 years, or 30 years, whichever is 
longer.
    (3) In the event that the employer ceases to do business and there 
is no successor to receive and retain his records for the prescribed 
period, these records shall be transmitted by registered mail to the 
Director, and each employee individually notified in writing of this 
transfer. The employer shall also comply with any additional 
requirements set forth in 29 CFR 1910.1020(h).
    (n) Employee notification of monitoring results. The employer must, 
within 15 working days after the receipt of the results of any 
monitoring performed under this section, notify each affected employee 
of these results and the steps being taken to reduce exposures within

[[Page 81]]

the permissible exposure limit either individually in writing or by 
posting the results in an appropriate location that is accessible to 
affected employees.

    Appendix A to Sec. 1910.1017--Supplementary Medical Information

    When required tests under paragraph (k)(1) of this section show 
abnormalities, the tests should be repeated as soon as practicable, 
preferably within 3 to 4 weeks. If tests remain abnormal, consideration 
should be given to withdrawal of the employee from contact with vinyl 
chloride, while a more comprehensive examination is made.
    Additional tests which may be useful:
    A. For kidney dysfunction: urine examination for albumin, red blood 
cells, and exfoliative abnormal cells.
    B. Pulmonary system: Forced vital capacity, Forced expiratory volume 
at 1 second, and chest roentgenogram (posterior-anterior, 14 x 17 
inches).
    C. Additional serum tests: Lactic acid dehydrogenase, lactic acid 
dehydrogenase isoenzyme, protein determination, and protein 
electrophoresis.
    D. For a more comprehensive examination on repeated abnormal serum 
tests: Hepatitis B antigen, and liver scanning.

[39 FR 35896, Oct. 4, 1974; 39 FR 41848, Dec. 3, 1974, as amended at 40 
FR 13211, Mar. 25, 1975. Redesignated at 40 FR 23072, May 28, 1975 and 
amended at 43 FR 49751, Oct. 24, 1978; 45 FR 35282, May 23, 1980; 54 FR 
24334, June 7, 1989; 58 FR 35310, June 30, 1993; 61 FR 5508, Feb. 13, 
1996; 63 FR 1286, Jan. 8, 1998; 70 FR 1141, Jan. 5, 2005; 71 FR 16672, 
16673, Apr. 3, 2006; 71 FR 50188, Aug. 24, 2006; 73 FR 75585, Dec. 12, 
2008]



Sec. 1910.1018  Inorganic arsenic.

    (a) Scope and application. This section applies to all occupational 
exposures to inorganic arsenic except that this section does not apply 
to employee exposures in agriculture or resulting from pesticide 
application, the treatment of wood with preservatives or the utilization 
of arsenically preserved wood.
    (b) Definitions. Action level means a concentration of inorganic 
arsenic of 5 micrograms per cubic meter of air (5 [micro]g/m\3\) 
averaged over any eight (8) hour period.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Authorized person means any person specifically authorized by the 
employer whose duties require the person to enter a regulated area, or 
any person entering such an area as a designated representative of 
employees for the purpose of exercising the right to observe monitoring 
and measuring procedures under paragraph (e) of this section.
    Director means the Director, National Institute for Occupational 
Safety and Health, U.S. Department of Health and Human Services, or 
designee.
    Inorganic arsenic means copper aceto- arsenite and all inorganic 
compounds containing arsenic except arsine, measured as arsenic (As).
    (c) Permissible exposure limit. The employer shall assure that no 
employee is exposed to inorganic arsenic at concentrations greater than 
10 micrograms per cubic meter of air (10 [micro]g/m\3\), averaged over 
any 8-hour period.
    (d) [Reserved]
    (e) Exposure monitoring--(1) General. (i) Determinations of airborne 
exposure levels shall be made from air samples that are representative 
of each employee's exposure to inorganic arsenic over an eight (8) hour 
period.
    (ii) For the purposes of this section, employee exposure is that 
exposure which would occur if the employee were not using a respirator.
    (iii) The employer shall collect full shift (for at least 7 
continuous hours) personal samples including at least one sample for 
each shift for each job classification in each work area.
    (2) Initial monitoring. Each employer who has a workplace or work 
operation covered by this standard shall monitor each such workplace and 
work operation to accurately determine the airborne concentration of 
inorganic arsenic to which employees may be exposed.
    (3) Frequency. (i) If the initial monitoring reveals employee 
exposure to be below the action level the measurements need not be 
repeated except as otherwise provided in paragraph (e)(4) of this 
section.
    (ii) If the initial monitoring, required by this section, or 
subsequent monitoring reveals employee exposure to be above the 
permissible exposure limit, the employer shall repeat monitoring at 
least quarterly.

[[Page 82]]

    (iii) If the initial monitoring, required by this section, or 
subsequent monitoring reveals employee exposure to be above the action 
level and below the permissible exposure limit the employer shall repeat 
monitoring at least every six months.
    (iv) The employer shall continue monitoring at the required 
frequency until at least two consecutive measurements, taken at least 
seven (7) days apart, are below the action level at which time the 
employer may discontinue monitoring for that employee until such time as 
any of the events in paragraph (e)(4) of this section occur.
    (4) Additional monitoring. Whenever there has been a production, 
process, control or personal change which may result in new or 
additional exposure to inorganic arsenic, or whenever the employer has 
any other reason to suspect a change which may result in new or 
additional exposures to inorganic arsenic, additional monitoring which 
complies with paragraph (e) of this section shall be conducted.
    (5) Employee notification. (i) The employer must, within 15 working 
days after the receipt of the results of any monitoring performed under 
this section, notify each affected employee of these results either 
individually in writing or by posting the results in an appropriate 
location that is accessible to affected employees.
    (ii) Whenever the results indicate that the representative employee 
exposure exceeds the permissible exposure limit, the employer shall 
include in the written notice a statement that the permissible exposure 
limit was exceeded and a description of the corrective action taken to 
reduce exposure to or below the permissible exposure limit.
    (6) Accuracy of measurement. (i) The employer shall use a method of 
monitoring and measurement which has an accuracy (with a confidence 
level of 95 percent) of not less than plus or minus 25 percent for 
concentrations of inorganic arsenic greater than or equal to 10 
[micro]g/m\3\.
    (ii) The employer shall use a method of monitoring and measurement 
which has an accuracy (with confidence level of 95 percent) of not less 
than plus or minus 35 percent for concentrations of inorganic arsenic 
greater than 5 [micro]g/m\3\ but less than 10 [micro]g/m\3\.
    (f) Regulated area--(1) Establishment. The employer shall establish 
regulated areas where worker exposures to inorganic arsenic, without 
regard to the use of respirators, are in excess of the permissible 
limit.
    (2) Demarcation. Regulated areas shall be demarcated and segregated 
from the rest of the workplace in any manner that minimizes the number 
of persons who will be exposed to inorganic arsenic.
    (3) Access. Access to regulated areas shall be limited to authorized 
persons or to persons otherwise authorized by the Act or regulations 
issued pursuant thereto to enter such areas.
    (4) Provision of respirators. All persons entering a regulated area 
shall be supplied with a respirator, selected in accordance with 
paragraph (h)(2) of this section.
    (5) Prohibited activities. The employer shall assure that in 
regulated areas, food or beverages are not consumed, smoking products, 
chewing tobacco and gum are not used and cosmetics are not applied, 
except that these activities may be conducted in the lunchrooms, change 
rooms and showers required under paragraph (m) of this section. Drinking 
water may be consumed in the regulated area.
    (g) Methods of compliance--(1) Controls. (i) The employer shall 
institute at the earliest possible time but not later than December 31, 
1979, engineering and work practice controls to reduce exposures to or 
below the permissible exposure limit, except to the extent that the 
employer can establish that such controls are not feasible.
    (ii) Where engineering and work practice controls are not sufficient 
to reduce exposures to or below the permissible exposure limit, they 
shall nonetheless be used to reduce exposures to the lowest levels 
achievable by these controls and shall be supplemented by the use of 
respirators in accordance with paragraph (h) of this section and other 
necessary personal protective equipment. Employee rotation is not 
required as a control strategy before respiratory protection is 
instituted.

[[Page 83]]

    (2) Compliance Program. (i) The employer shall establish and 
implement a written program to reduce exposures to or below the 
permissible exposure limit by means of engineering and work practice 
controls.
    (ii) Written plans for these compliance programs shall include at 
least the following:
    (A) A description of each operation in which inorganic arsenic is 
emitted; e.g. machinery used, material processed, controls in place, 
crew size, operating procedures and maintenance practices;
    (B) Engineering plans and studies used to determine methods selected 
for controlling exposure to inorganic arsenic;
    (C) A report of the technology considered in meeting the permissible 
exposure limit;
    (D) Monitoring data;
    (E) A detailed schedule for implementation of the engineering 
controls and work practices that cannot be implemented immediately and 
for the adaption and implementation of any additional engineering and 
work practices necessary to meet the permissible exposure limit;
    (F) Whenever the employer will not achieve the permissible exposure 
limit with engineering controls and work practices by December 31, 1979, 
the employer shall include in the compliance plan an analysis of the 
effectiveness of the various controls, shall install engineering 
controls and institute work practices on the quickest schedule feasible, 
and shall include in the compliance plan and implement a program to 
minimize the discomfort and maximize the effectiveness of respirator 
use; and
    (G) Other relevant information.
    (iii) Written plans for such a program shall be submitted upon 
request to the Assistant Secretary and the Director, and shall be 
available at the worksite for examination and copying by the Assistant 
Secretary, Director, any affected employee or authorized employee 
representatives.
    (iv) The plans required by this paragraph must be revised and 
updated at least annually to reflect the current status of the program.
    (h) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer must provide each 
employee an appropriate respirator that complies with the requirements 
of this paragraph. Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
or work-practice controls.
    (ii) Work operations, such as maintenance and repair activities, for 
which the employer establishes that engineering and work-practice 
controls are not feasible.
    (iii) Work operations for which engineering and work-practice 
controls are not yet sufficient to reduce employee exposures to or below 
the permissible exposure limit.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with Sec. 1910.134(b) 
through (d) (except (d)(1)(iii)), and (f) through (m), which covers each 
employee required by this section to use a respirator.
    (ii) If an employee exhibits breathing difficulty during fit testing 
or respirator use, they must be examined by a physician trained in 
pulmonary medicine to determine whether they can use a respirator while 
performing the required duty.
    (3) Respirator selection. (i) Employers must:
    (A) Select, and provide to employees, the appropriate respirators 
specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134.
    (B) Ensure that employees do not use half mask respirators for 
protection against arsenic trichloride because it is absorbed rapidly 
through the skin.
    (C) Provide HEPA filters for powered and non-powered air-purifying 
respirators.
    (D) Select for employee use:
    (1) Air-purifying respirators that have a combination HEPA filter 
with an appropriate gas-sorbent cartridge or canister when the 
employee's exposure exceeds the permissible exposure level for inorganic 
arsenic and the relevant limit for other gases.
    (2) Front-or back-mounted gas masks equipped with HEPA filters and 
acid gas canisters or any full facepiece supplied-air respirators when 
the inorganic arsenic concentration is at or

[[Page 84]]

below 500 mg/m\3\; and half mask air-purifying respirators equipped with 
HEPA filters and acid gas cartridges when the inorganic arsenic 
concentration is at or below 100 [mu]g/m\3\.
    (ii) Employees required to use respirators may choose, and the 
employer must provide, a powered air-purifying respirator if it will 
provide proper protection. In addition, the employer must provide a 
combination dust and acid-gas respirator to employees who are exposed to 
gases over the relevant exposure limits.
    (i) [Reserved]
    (j) Protective work clothing and equipment--(1) Provision and use. 
Where the possibility of skin or eye irritation from inorganic arsenic 
exists, and for all workers working in regulated areas, the employer 
shall provide at no cost to the employee and assure that employees use 
appropriate and clean protective work clothing and equipment such as, 
but not limited to:
    (i) Coveralls or similar full-body work clothing;
    (ii) Gloves, and shoes or coverlets;
    (iii) Face shields or vented goggles when necessary to prevent eye 
irritation, which comply with the requirements of Sec. 1910.133(a) (2)-
(6); and
    (iv) Impervious clothing for employees subject to exposure to 
arsenic trichloride.
    (2) Cleaning and replacement. (i) The employer shall provide the 
protective clothing required in paragraph (j) (1) of this section in a 
freshly laundered and dry condition at least weekly, and daily if the 
employee works in areas where exposures are over 100 [micro]g/m\3\ of 
inorganic arsenic or in areas where more frequent washing is needed to 
prevent skin irritation.
    (ii) The employer shall clean, launder, or dispose of protective 
clothing required by paragraph (j) (1) of this section.
    (iii) The employer shall repair or replace the protective clothing 
and equipment as needed to maintain their effectiveness.
    (iv) The employer shall assure that all protective clothing is 
removed at the completion of a work shift only in change rooms 
prescribed in paragraph (m) (1) of this section.
    (v) The employer shall assure that contaminated protective clothing 
which is to be cleaned, laundered, or disposed of, is placed in a closed 
container in the change-room which prevents dispersion of inorganic 
arsenic outside the container.
    (vi) The employer shall inform in writing any person who cleans or 
launders clothing required by this section, of the potentially harmful 
effects including the carcinogenic effects of exposure to inorganic 
arsenic.
    (vii) The employer shall assure that the containers of contaminated 
protective clothing and equipment in the workplace or which are to be 
removed from the workplace are labelled as follows:

    Caution: Clothing contaminated with inorganic arsenic; do not remove 
dust by blowing or shaking. Dispose of inorganic arsenic contaminated 
wash water in accordance with applicable local, State or Federal 
regulations.

    (viii) The employer shall prohibit the removal of inorganic arsenic 
from protective clothing or equipment by blowing or shaking.
    (k) Housekeeping--(1) Surfaces. All surfaces shall be maintained as 
free as practicable of accumulations of inorganic arsenic.
    (2) Cleaning floors. Floors and other accessible surfaces 
contaminated with inorganic arsenic may not be cleaned by the use of 
compressed air, and shoveling and brushing may be used only where 
vacuuming or other relevant methods have been tried and found not to be 
effective.
    (3) Vacuuming. Where vacuuming methods are selected, the vacuums 
shall be used and emptied in a manner to minimize the reentry of 
inorganic arsenic into the workplace.
    (4) Housekeeping plan. A written housekeeping and maintenance plan 
shall be kept which shall list appropriate frequencies for carrying out 
housekeeping operations, and for cleaning and maintaining dust 
collection equipment. The plan shall be available for inspection by the 
Assistant Secretary.
    (5) Maintenance of equipment. Periodic cleaning of dust collection 
and ventilation equipment and checks of their effectiveness shall be 
carried out to

[[Page 85]]

maintain the effectiveness of the system and a notation kept of the last 
check of effectiveness and cleaning or maintenance.
    (l) [Reserved]
    (m) Hygiene facilities and practices--(1) Change rooms. The employer 
shall provide for employees working in regulated areas or subject to the 
possibility of skin or eye irritation from inorganic arsenic, clean 
change rooms equipped with storage facilities for street clothes and 
separate storage facilities for protective clothing and equipment in 
accordance with 29 CFR 1910.141(e).
    (2) Showers. (i) The employer shall assure that employees working in 
regulated areas or subject to the possibility of skin or eye irritation 
from inorganic arsenic shower at the end of the work shift.
    (ii) The employer shall provide shower facilities in accordance with 
Sec. 1910.141(d)(3).
    (3) Lunchrooms. (i) The employer shall provide for employees working 
in regulated areas, lunchroom facilities which have a temperature 
controlled, positive pressure, filtered air supply, and which are 
readily accessible to employees working in regulated areas.
    (ii) The employer shall assure that employees working in the 
regulated area or subject to the possibility of skin or eye irritation 
from exposure to inorganic arsenic wash their hands and face prior to 
eating.
    (4) Lavatories. The employer shall provide lavatory facilities which 
comply with Sec. 1910.141(d) (1) and (2).
    (5) Vacuuming clothes. The employer shall provide facilities for 
employees working in areas where exposure, without regard to the use of 
respirators, exceeds 100 [micro]g/m\3\ to vacuum their protective 
clothing and clean or change shoes worn in such areas before entering 
change rooms, lunchrooms or shower rooms required by paragraph (j) of 
this section and shall assure that such employees use such facilities.
    (6) Avoidance of skin irritation. The employer shall assure that no 
employee is exposed to skin or eye contact with arsenic trichloride, or 
to skin or eye contact with liquid or particulate inorganic arsenic 
which is likely to cause skin or eye irritation.
    (n) Medical surveillance--(1) General--(i) Employees covered. The 
employer shall institute a medical surveillance program for the 
following employees:
    (A) All employees who are or will be exposed above the action level, 
without regard to the use of respirators, at least 30 days per year; and
    (B) All employees who have been exposed above the action level, 
without regard to respirator use, for 30 days or more per year for a 
total of 10 years or more of combined employment with the employer or 
predecessor employers prior to or after the effective date of this 
standard. The determination of exposures prior to the effective date of 
this standard shall be based upon prior exposure records, comparison 
with the first measurements taken after the effective date of this 
standard, or comparison with records of exposures in areas with similar 
processes, extent of engineering controls utilized and materials used by 
that employer.
    (ii) Examination by physician. The employer shall assure that all 
medical examinations and procedures are performed by or under the 
supervision of a licensed physician, and shall be provided without cost 
to the employee, without loss of pay and at a reasonable time and place.
    (2) Initial examinations. By December 1, 1978, for employees 
initially covered by the medical provisions of this section, or 
thereafter at the time of initial assignment to an area where the 
employee is likely to be exposed over the action level at least 30 days 
per year, the employer shall provide each affected employee an 
opportunity for a medical examination, including at least the following 
elements:
    (i) A work history and a medical history which shall include a 
smoking history and the presence and degree of respiratory symptoms such 
as breathlessness, cough, sputum production and wheezing.
    (ii) A medical examination which shall include at least the 
following:
    (A) A standard posterior-anterior chest x-ray;
    (B) A nasal and skin examination; and
    (C) Other examinations which the physician believes appropriate 
because of the employees exposure to inorganic

[[Page 86]]

arsenic or because of required respirator use.
    (3) Periodic examinations. (i) Examinations must be provided in 
accordance with this paragraph at least annually.
    (ii) Whenever a covered employee has not taken the examinations 
specified in paragraphs (n)(2)(i) and (n)(2)(ii) of this section within 
six (6) months preceding the termination of employment, the employer 
shall provide such examinations to the employee upon termination of 
employment.
    (4) Additional examinations. If the employee for any reason develops 
signs or symptoms commonly associated with exposure to inorganic arsenic 
the employer shall provide an appropriate examination and emergency 
medical treatment.
    (5) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this standard and its appendices;
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (iii) The employee's representative exposure level or anticipated 
exposure level;
    (iv) A description of any personal protective equipment used or to 
be used; and
    (v) Information from previous medical examinations of the affected 
employee which is not readily available to the examining physician.
    (6) Physician's written opinion. (i) The employer shall obtain a 
written opinion from the examining physician which shall include:
    (A) The results of the medical examination and tests performed;
    (B) The physician's opinion as to whether the employee has any 
detected medical conditions which would place the employee at increased 
risk of material impairment of the employee's health from exposure to 
inorganic arsenic;
    (C) Any recommended limitations upon the employee's exposure to 
inorganic arsenic or upon the use of protective clothing or equipment 
such as respirators; and
    (D) A statement that the employee has been informed by the physician 
of the results of the medical examination and any medical conditions 
which require further explanation or treatment.
    (ii) The employer shall instruct the physician not to reveal in the 
written opinion specific findings or diagnoses unrelated to occupational 
exposure.
    (iii) The employer shall provide a copy of the written opinion to 
the affected employee.
    (o) Employee information and training--(1) Training program. (i) The 
employer shall train each employee who is subject to exposure to 
inorganic arsenic above the action level without regard to respirator 
use, or for whom there is the possibility of skin or eye irritation from 
inorganic arsenic, in accordance with the requirements of this section. 
The employer shall institute a training program and ensure employee 
participation in the program.
    (ii) The training program shall be provided by October 1, 1978, for 
employees covered by this provision, at the time of initial assignment 
for those subsequently covered by this provision, and at least annually 
for other covered employees thereafter; and the employer shall assure 
that each employee is informed of the following:
    (A) The information contained in Appendix A;
    (B) The quantity, location, manner of use, storage, sources of 
exposure, and the specific nature of operations which could result in 
exposure to inorganic arsenic as well as any necessary protective steps;
    (C) The purpose, proper use, and limitation of respirators;
    (D) The purpose and a description of the medical surveillance 
program as required by paragraph (n) of this section;
    (E) The engineering controls and work practices associated with the 
employee's job assignment; and
    (F) A review of this standard.
    (2) Access to training materials. (i) The employer shall make 
readily available to all affected employees a copy of this standard and 
its appendices.
    (ii) The employer shall provide; upon request, all materials 
relating to the employee information and training program to the 
Assistant Secretary and the Director.

[[Page 87]]

    (p) Signs and labels--(1) General. (i) The employer may use labels 
or signs required by other statutes, regulations, or ordinances in 
addition to, or in combination with, signs and labels required by this 
paragraph.
    (ii) The employer shall assure that no statement appears on or near 
any sign or label required by this paragraph which contradicts or 
detracts from the meaning of the required sign or label.
    (2) Signs. (i) The employer shall post signs demarcating regulated 
areas bearing the legend;

                                 DANGER

                            INORGANIC ARSENIC

                              CANCER HAZARD

                        AUTHORIZED PERSONNEL ONLY

                          NO SMOKING OR EATING

                           RESPIRATOR REQUIRED

    (ii) The employer shall assure that signs required by this paragraph 
are illuminated and cleaned as necessary so that the legend is readily 
visible.
    (3) Labels. The employer shall apply precautionary labels to all 
shipping and storage containers of inorganic arsenic, and to all 
products containing inorganic arsenic except when the inorganic arsenic 
in the product is bound in such a manner so as to make unlikely the 
possibility of airborne exposure to inorganic arsenic. (Possible 
examples of products not requiring labels are semiconductors, light 
emitting diodes and glass). The label shall bear the following legend:

                                 DANGER

                       CONTAINS INORGANIC ARSENIC

                              CANCER HAZARD

                     HARMFUL IF INHALED OR SWALLOWED

                   USE ONLY WITH ADEQUATE VENITLATION

                        OR RESPIRATORY PROTECTION

    (q) Recordkeeping--(1) Exposure monitoring. (i) The employer shall 
establish and maintain an accurate record of all monitoring required by 
paragraph (e) of this section.
    (ii) This record shall include:
    (A) The date(s), number, duration location, and results of each of 
the samples taken, including a description of the sampling procedure 
used to determine representative employee exposure where applicable;
    (B) A description of the sampling and analytical methods used and 
evidence of their accuracy;
    (C) The type of respiratory protective devices worn, if any;
    (D) Name, social security number, and job classification of the 
employees monitored and of all other employees whose exposure the 
measurement is intended to represent; and
    (E) The environmental variables that could affect the measurement of 
the employee's exposure.
    (iii) The employer shall maintain these monitoring records for at 
least 40 years or for the duration of employment plus 20 years, 
whichever, is longer.
    (2) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance as required by paragraph (n) of this section.
    (ii) This record shall include:
    (A) The name, social security number, and description of duties of 
the employee;
    (B) A copy of the physician's written opinions;
    (C) Results of any exposure monitoring done for that employee and 
the representative exposure levels supplied to the physician; and
    (D) Any employee medical complaints related to exposure to inorganic 
arsenic.
    (iii) The employer shall in addition keep, or assure that the 
examining physician keeps, the following medical records;
    (A) A copy of the medical examination results including medical and 
work history required under paragraph (n) of this section;
    (B) A description of the laboratory procedures and a copy of any 
standards or guidelines used to interpret the test results or references 
to that information;
    (C) The initial X-ray;
    (D) The X-rays for the most recent 5 years; and
    (E) Any X-rays with a demonstrated abnormality and all subsequent X-
rays;
    (iv) The employer shall maintain or assure that the physician 
maintains those medical records for at least 40 years, or for the 
duration of employment plus 20 years whichever is longer.
    (3) Availability. (i) The employer shall make available upon request 
all records required to be maintained by

[[Page 88]]

paragraph (q) of this section to the Assistant Secretary and the 
Director for examination and copying.
    (ii) Records required by this paragraph shall be provided upon 
request to employees, designated representatives, and the Assistant 
Secretary in accordance with 29 CFR 1910.1020 (a) through (e) and (g) 
through (i).
    (4) Transfer of records. (i) Whenever the employer ceases to do 
business, the successor employer shall receive and retain all records 
required to be maintained by this section.
    (ii) Whenever the employer ceases to do business and there is no 
successor employer to receive and retain the records required to be 
maintained by this section for the prescribed period, these records 
shall be transmitted to the Director.
    (iii) At the expiration of the retention period for the records 
required to be maintained by this section, the employer shall notify the 
Director at least 3 months prior to the disposal of such records and 
shall transmit those records to the Director if he requests them within 
that period.
    (iv) The employer shall also comply with any additional requirements 
involving the transfer of records set in 29 CFR 1910.1020(h).
    (r) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees or their designated 
representatives an opportunity to observe any monitoring of employee 
exposure to inorganic arsenic conducted pursuant to paragraph (e) of 
this section.
    (2) Observation procedures. (i) Whenever observation of the 
monitoring of employee exposure to inorganic arsenic requires entry into 
an area where the use of respirators, protective clothing, or equipment 
is required, the employer shall provide the observer with and assure the 
use of such respirators, clothing, and such equipment, and shall require 
the observer to comply with all other applicable safety and health 
procedures.
    (ii) Without interfering with the monitoring, observers shall be 
entitled to;
    (A) Receive an explanation of the measurement procedures;
    (B) Observe all steps related to the monitoring of inorganic arsenic 
performed at the place of exposure; and
    (C) Record the results obtained or receive copies of the results 
when returned by the laboratory.
    (s) Appendices. The information contained in the appendices to this 
section is not intended by itself, to create any additional obligations 
not otherwise imposed by this standard nor detract from any existing 
obligation.

 Appendix A to Sec. 1910.1018--Inorganic Arsenic Substance Information 
                                  Sheet

                       i. substance identification

    A. Substance. Inorganic Arsenic.
    B. Definition. Copper acetoarsenite, arsenic and all inorganic 
compounds containing arsenic except arsine, measured as arsenic (As).
    C. Permissible Exposure Limit. 10 micrograms per cubic meter of air 
as determined as an average over an 8-hour period. No employee may be 
exposed to any skin or eye contact with arsenic trichloride or to skin 
or eye contact likely to cause skin or eye irritation.
    D. Regulated Areas. Only employees authorized by your employer 
should enter a regulated area.

                         ii. health hazard data

    A. Comments. The health hazard of inorganic arsenic is high.
    B. Ways in which the chemical affects your body. Exposure to 
airborne concentrations of inorganic arsenic may cause lung cancer, and 
can be a skin irritant. Inorganic arsenic may also affect your body if 
swallowed. One compound in particular, arsenic trichloride, is 
especially dangerous because it can be absorbed readily through the 
skin. Because inorganic arsenic is a poison, you should wash your hands 
thoroughly prior to eating or smoking.

                 iii. protective clothing and equipment

    A. Respirators. Respirators will be provided by your employer at no 
cost to you for routine use if your employer is in the process of 
implementing engineering and work practice controls or where engineering 
and work practice controls are not feasible or insufficient. You must 
wear respirators for non-routine activities or in emergency situations 
where you are likely to be exposed to levels of inorganic arsenic in 
excess of the permissible exposure limit. Since how well your respirator 
fits your face is very important, your employer is required to conduct 
fit tests to make sure the respirator seals properly when you wear it. 
These tests are simple

[[Page 89]]

and rapid and will be explained to you during training sessions.
    B. Protective clothing. If you work in a regulated area, your 
employer is required to provide at no cost to you, and you must wear, 
appropriate, clean, protective clothing and equipment. The purpose of 
this equipment is to prevent you from bringing to your home arsenic-
contaminated dust and to protect your body from repeated skin contact 
with inorganic arsenic likely to cause skin irritation. This clothing 
should include such items as coveralls or similar full-body clothing, 
gloves, shoes or coverlets, and aprons. Protective equipment should 
include face shields or vented goggles, where eye irritation may occur. 
y

                  iv. hygiene facilities and practices

    You must not eat, drink, smoke, chew gum or tobacco, or apply 
cosmetics in the regulated area, except that drinking water is 
permitted. If you work in a regulated area your employer is required to 
provide lunchrooms and other areas for these purposes.
    If you work in a regulated area, your employer is required to 
provide showers, washing facilities, and change rooms. You must wash 
your face, and hands before eating and must shower at the end of the 
work shift. Do not take used protective clothing out of change rooms 
without your employer's permission. Your employer is required to provide 
for laundering or cleaning of your protective clothing.

                           v. signs and labels

    Your employer is required to post warning signs and labels for your 
protection. Signs must be posted in regulated areas. The signs must warn 
that a cancer hazard is present, that only authorized employees may 
enter the area, and that no smoking or eating is allowed, and that 
respirators must be worn.

                        vi. medical examinations

    If your exposure to arsenic is over the Action Level (5 microg/
m\3\)--(including all persons working in regulated areas) at least 30 
days per year, or you have been exposed to arsenic for more than 10 
years over the Action Level, your employer is required to provide you 
with a medical examination. The examination shall be every 6 months for 
employees over 45 years old or with more than 10 years exposure over the 
Action Level and annually for other covered employees. The medical 
examination must include a medical history; a chest x-ray; a skin 
examination and a nasal examination. The examining physician will 
provide a written opinion to your employer containing the results of 
your medical exams. You should also receive a copy of this opinion. The 
physician must not tell your employer any conditions he detects 
unrelated to occupational exposure to arsenic but must tell you those 
conditions.

                     vii. observation of monitoring

    Your employer is required to monitor your exposure to arsenic and 
you or your representatives are entitled to observe the monitoring 
procedure. You are entitled to receive an explanation of the measurement 
procedure, and to record the results obtained. When the monitoring 
procedure is taking place in an area where respirators or personal 
protective clothing and equipment are required to be worn, you must also 
be provided with and must wear the protective clothing and equipment.

                         viii. access to records

    You or your representative are entitled to records of your exposure 
to inorganic arsenic and your medical examination records if you request 
your employer to provide them.

                      ix. training and notification

    Additional information on all of these items plus training as to 
hazards of exposure to inorganic arsenic and the engineering and work 
practice controls associated with your job will also be provided by your 
employer. If you are exposed over the permissible exposure limit, your 
employer must inform you of that fact and the actions he is taking to 
reduce your exposures.

      Appendix B to Sec. 1910.1018--Substance Technical Guidelines

     arsenic, arsenic trioxide, arsenic trichloride (three examples)

I. Physical and chemical properties

    A. Arsenic (metal).
    1. Formula: As.
    2. Appearance: Gray metal.
    3. Melting point: Sublimes without melting at 613C.
    4. Specific Gravity: (H20=1):5.73.
    5. Solubility in water: Insoluble.
    B. Arsenic Trioxide.
    1. Formula: As203, (As406).
    2. Appearance: White powder.
    3. Melting point: 315C.
    4. Specific Gravity (H20=1):3.74.
    5. Solubility in water: 3.7 grams in 100cc of water at 20c.
    C. Arsenic Trichloride (liquid).
    1. Formula: AsC13.
    2. Appearance: Colorless or pale yellow liquid.
    3. Melting point: -8.5C.
    4. Boiling point: 130.2C.
    5. Specific Gravity (H20=1):2.16 at 20C.
    6. Vapor Pressure: 10mm Hg at 23.5C.
    7. Solubility in Water: Decomposes in water.

II. Fire, explosion and reactivity data.


[[Page 90]]


    A. Fire: Arsenic, arsenic Trioxide and Arsenic Trichloride are 
nonflammable.
    B. Reactivity:
    1. Conditions Contributing to instability: Heat.
    2. Incompatibility: Hydrogen gas can react with inorganic arsenic to 
form the highly toxic gas arsine.

III. Monitoring and Measurement Procedures

    Samples collected should be full shift (at least 7-hour) samples. 
Sampling should be done using a personal sampling pump at a flow rate of 
2 liters per minute. Samples should be collected on 0.8 micrometer pore 
size membrane filter (37mm diameter). Volatile arsenicals such as 
arsenic trichloride can be most easily collected in a midget bubbler 
filled with 15 ml. of 0.1 N NaOH.
    The method of sampling and analysis should have an accuracy of not 
less than 25 percent (with a confidence limit of 
95 percent) for 10 micrograms per cubic meter of air (10 [micro]g/m\3\) 
and 35 percent (with a confidence limit of 95 
percent) for concentrations of inorganic arsenic between 5 and 10 
[micro]g/m\3\.

     Appendix C to Sec. 1910.1018--Medical Surveillance Guidelines

                               I. General

    Medical examinations are to be provided for all employees exposed to 
levels of inorganic arsenic above the action level (5 [micro]g/m\3\) for 
at least 30 days per year (which would include among others, all 
employees, who work in regulated areas). Examinations are also to be 
provided to all employees who have had 10 years or more exposure above 
the action level for more than 30 days per year while working for the 
present or predecessor employer though they may no longer be exposed 
above the level.
    An initial medical examination is to be provided to all such 
employees by December 1, 1978. In addition, an initial medical 
examination is to be provided to all employees who are first assigned to 
areas in which worker exposure will probably exceed 5 [micro]g/m\3\ 
(after the effective date of this standard) at the time of initial 
assignment. In addition to its immediate diagnostic usefulness, the 
initial examination will provide a baseline for comparing future test 
results. The initial examination must include as a minimum the following 
elements:
    (1) A work and medical history, including a smoking history, and 
presence and degree of respiratory symptoms such as breathlessness, 
cough, sputum production, and wheezing;
    (2) A 14 by 17 posterior-anterior chest X-ray;
    (3) A nasal and skin examination; and
    (4) Other examinations which the physician believes appropriate 
because of the employee's exposure to inorganic arsenic or because of 
required respirator use.
    Periodic examinations are also to be provided to the employees 
listed above. The periodic examinations shall be given annually for 
those covered employees 45 years of age or less with fewer than 10 years 
employment in areas where employee exposure exceeds the action level (5 
[micro]g/m\3\). Periodic examinations need not include sputum cytology 
and only an updated medical history is required.
    Periodic examinations for other covered employees, shall be provided 
every six (6) months. These examinations shall include all tests 
required in the initial examination, except that the medical history 
need only be updated.
    The examination contents are minimum requirements. Additional tests 
such as lateral and oblique X-rays or pulmonary function tests may be 
useful. For workers exposed to three arsenicals which are associated 
with lymphatic cancer, copper acetoarsenite, potassium arsenite, or 
sodium arsenite the examination should also include palpation of 
superficial lymph nodes and complete blood count.

                       ii. noncarcinogenic effects

    The OSHA standard is based on minimizing risk of exposed workers 
dying of lung cancer from exposure to inorganic arsenic. It will also 
minimize skin cancer from such exposures.
    The following three sections quoted from ``Occupational Diseases: A 
Guide to Their Recognition'', Revised Edition, June 1977, National 
Institute for Occupational Safety and Health is included to provide 
information on the nonneoplastic effects of exposure to inorganic 
arsenic. Such effects should not occur if the OSHA standards are 
followed.
    A. Local--Trivalent arsenic compounds are corrosive to the skin. 
Brief contact has no effect but prolonged contact results in a local 
hyperemia and later vesicular or pustular eruption. The moist mucous 
membranes are most sensitive to the irritant action. Conjunctiva, moist 
and macerated areas of skin, the eyelids, the angles of the ears, nose, 
mouth, and respiratory mucosa are also vulnerable to the irritant 
effects. The wrists are common sites of dermatitis, as are the genitalia 
if personal hygiene is poor. Perforations of the nasal septum may occur. 
Arsenic trioxide and pentoxide are capable of producing skin 
sensitization and contact dermatitis. Arsenic is also capable of 
producing keratoses, especially of the palms and soles.
    B. Systemic--The acute toxic effects of arsenic are generally seen 
following ingestion of inorganic arsenical compounds. This rarely occurs 
in an industrial setting. Symptoms

[[Page 91]]

develop within \1/2\ to 4 hours following ingestion and are usually 
characterized by constriction of the throat followed by dysphagia, 
epigastric pain, vomiting, and watery diarrhea. Blood may appear in 
vomitus and stools. If the amount ingested is sufficiently high, shock 
may develop due to severe fluid loss, and death may ensue in 24 hours. 
If the acute effects are survived, exfoliative dermatitis and peripheral 
neuritis may develop.
    Cases of acute arsenical poisoning due to inhalation are exceedingly 
rare in industry. When it does occur, respiratory tract symptoms--cough, 
chest pain, dyspnea--giddiness, headache, and extreme general weakness 
precede gastrointestinal symptoms. The acute toxic symptoms of trivalent 
arsenical poisoning are due to severe inflammation of the mucous 
membranes and greatly increased permeability of the blood capillaries.
    Chronic arsenical poisoning due to ingestion is rare and generally 
confined to patients taking prescribed medications. However, it can be a 
concomitant of inhaled inorganic arsenic from swallowed sputum and 
improper eating habits. Symptoms are weight loss, nausea and diarrhea 
alternating with constipation, pigmentation and eruption of the skin, 
loss of hair, and peripheral neuritis. Chronic hepatitis and cirrhosis 
have been described. Polyneuritis may be the salient feature, but more 
frequently there are numbness and parasthenias of ``glove and stocking'' 
distribution. The skin lesions are usually melanotic and keratotic and 
may occasionally take the form of an intradermal cancer of the squamous 
cell type, but without infiltrative properties. Horizontal white lines 
(striations) on the fingernails and toenails are commonly seen in 
chronic arsenical poisoning and are considered to be a diagnostic 
accompaniment of arsenical polyneuritis.
    Inhalation of inorganic arsenic compounds is the most common cause 
of chronic poisoning in the industrial situation. This condition is 
divided into three phases based on signs and symptoms.
    First Phase: The worker complains of weakness, loss of appetite, 
some nausea, occasional vomiting, a sense of heaviness in the stomach, 
and some diarrhea.
    Second Phase: The worker complains of conjunctivitis, a catarrhal 
state of the mucous membranes of the nose, larynx, and respiratory 
passage. Coryza, hoarseness, and mild tracheobronchitis may occur. 
Perforation of the nasal septum is common, and is probably the most 
typical lesion of the upper respiratory tract in occupational exposure 
to arsenical dust. Skin lesions, eczematoid and allergic in type, are 
common.
    Third Phase: The worker complains of symptoms of peripheral 
neuritis, initially of hands and feet, which is essentially sensory. In 
more severe cases, motor paralyses occur; the first muscles affected are 
usually the toe extensors and the peronei. In only the most severe cases 
will paralysis of flexor muscles of the feet or of the extensor muscles 
of hands occur.
    Liver damage from chronic arsenical poisoning is still debated, and 
as yet the question is unanswered. In cases of chronic and acute 
arsenical poisoning, toxic effects to the myocardium have been reported 
based on EKG changes. These findings, however, are now largely 
discounted and the EKG changes are ascribed to electrolyte disturbances 
concomitant with arsenicalism. Inhalation of arsenic trioxide and other 
inorganic arsenical dusts does not give rise to radiological evidence or 
pneumoconiosis. Arsenic does have a depressant effect upon the bone 
marrow, with disturbances of both erythropoiesis and myelopoiesis.

                              Bibliography

    Dinman, B. D. 1960. Arsenic; chronic human intoxication. J. Occup. 
Med. 2:137.
    Elkins, H. B. 1959. The Chemistry of Industrial Toxicology, 2nd ed. 
John Wiley and Sons, New York.
    Holmquist, L. 1951. Occupational arsenical dermatitis; a study among 
employees at a copper-ore smelting works including investigations of 
skin reactions to contact with arsenic compounds. Acta. Derm. Venereol. 
(Supp. 26) 31:1.
    Pinto, S. S., and C. M. McGill. 1953. Arsenic trioxide exposure in 
industry. Ind. Med. Surg. 22:281.
    Pinto, S. S., and K. W. Nelson. 1976. Arsenic toxicology and 
industrial exposure. Annu. Rev. Pharmacol. Toxicol. 16:95.
    Vallee, B. L., D. D. Ulmer, and W. E. C. Wacker. 1960. Arsenic 
toxicology and biochemistry. AMA Arch. Indust. Health 21:132.

[39 FR 23502, June 27, 1974, as amended at 43 FR 19624, May 5, 1978; 43 
FR 28472, June 30, 1978; 45 FR 35282, May 23, 1980; 54 FR 24334, June 7, 
1989; 58 FR 35310, June 30, 1993; 61 FR 5508, Feb. 13, 1996; 61 FR 9245, 
Mar. 7, 1996; 63 FR 1286, Jan. 8, 1998; 63 FR 33468, June 18, 1998; 70 
FR 1141, Jan. 5, 2005; 71 FR 16672, 16673, Apr. 3, 2006; 71 FR 50189, 
Aug. 24, 2006; 73 FR 75585, Dec. 12, 2008]



Sec. 1910.1020  Access to employee exposure and medical records.

    (a) Purpose. The purpose of this section is to provide employees and 
their designated representatives a right of access to relevant exposure 
and medical records; and to provide representatives of the Assistant 
Secretary a right of access to these records in order to fulfill 
responsibilities under the Occupational Safety and Health Act. Access by 
employees, their representatives,

[[Page 92]]

and the Assistant Secretary is necessary to yield both direct and 
indirect improvements in the detection, treatment, and prevention of 
occupational disease. Each employer is responsible for assuring 
compliance with this section, but the activities involved in complying 
with the access to medical records provisions can be carried out, on 
behalf of the employer, by the physician or other health care personnel 
in charge of employee medical records. Except as expressly provided, 
nothing in this section is intended to affect existing legal and ethical 
obligations concerning the maintenance and confidentiality of employee 
medical information, the duty to disclose information to a patient/
employee or any other aspect of the medical-care relationship, or affect 
existing legal obligations concerning the protection of trade secret 
information.
    (b) Scope and application. (1) This section applies to each general 
industry, maritime, and construction employer who makes, maintains, 
contracts for, or has access to employee exposure or medical records, or 
analyses thereof, pertaining to employees exposed to toxic substances or 
harmful physical agents.
    (2) This section applies to all employee exposure and medical 
records, and analyses thereof, of such employees, whether or not the 
records are mandated by specific occupational safety and health 
standards.
    (3) This section applies to all employee exposure and medical 
records, and analyses thereof, made or maintained in any manner, 
including on an in-house of contractual (e.g., fee-for-service) basis. 
Each employer shall assure that the preservation and access requirements 
of this section are complied with regardless of the manner in which the 
records are made or maintained.
    (c) Definitions. (1) Access means the right and opportunity to 
examine and copy.
    (2) Analysis using exposure or medical records means any compilation 
of data or any statistical study based at least in part on information 
collected from individual employee exposure or medical records or 
information collected from health insurance claims records, provided 
that either the analysis has been reported to the employer or no further 
work is currently being done by the person responsible for preparing the 
analysis.
    (3) Designated representative means any individual or organization 
to whom an employee gives written authorization to exercise a right of 
access. For the purposes of access to employee exposure records and 
analyses using exposure or medical records, a recognized or certified 
collective bargaining agent shall be treated automatically as a 
designated representative without regard to written employee 
authorization.
    (4) Employee means a current employee, a former employee, or an 
employee being assigned or transferred to work where there will be 
exposure to toxic substances or harmful physical agents. In the case of 
a deceased or legally incapacitated employee, the employee's legal 
representative may directly exercise all the employee's rights under 
this section.
    (5) Employee exposure record means a record containing any of the 
following kinds of information:
    (i) Environmental (workplace) monitoring or measuring of a toxic 
substance or harmful physical agent, including personal, area, grab, 
wipe, or other form of sampling, as well as related collection and 
analytical methodologies, calculations, and other background data 
relevant to interpretation of the results obtained;
    (ii) Biological monitoring results which directly assess the 
absorption of a toxic substance or harmful physical agent by body 
systems (e.g., the level of a chemical in the blood, urine, breath, 
hair, fingernails, etc) but not including results which assess the 
biological effect of a substance or agent or which assess an employee's 
use of alcohol or drugs;
    (iii) Material safety data sheets indicating that the material may 
pose a hazard to human health; or
    (iv) In the absence of the above, a chemcial inventory or any other 
record which reveals where and when used and the identity (e.g., 
chemical, common, or trade name) of a toxic substance or harmful 
physical agent.

[[Page 93]]

    (6)(i) Employee medical record means a record concerning the health 
status of an employee which is made or maintained by a physician, nurse, 
or other health care personnel or technician, including:
    (A) Medical and employment questionnaires or histories (including 
job description and occupational exposures),
    (B) The results of medical examinations (pre-employment, pre-
assignment, periodic, or episodic) and laboratory tests (including chest 
and other X-ray examinations taken for the purposes of establishing a 
base-line or detecting occupational illness, and all biological 
monitoring not defined as an ``employee exposure record''),
    (C) Medical opinions, diagnoses, progress notes, and 
recommendations,
    (D) First aid records,
    (E) Descriptions of treatments and prescriptions, and
    (F) Employee medical complaints.
    (ii) ``Employee medical record'' does not include medical 
information in the form of:
    (A) Physical specimens (e.g., blood or urine samples) which are 
routinely discarded as a part of normal medical practice; or
    (B) Records concerning health insurance claims if maintained 
separately from the employer's medical program and its records, and not 
accessible to the employer by employee name or other direct personal 
identifier (e.g., social security number, payroll number, etc.); or
    (C) Records created solely in preparation for litigation which are 
privileged from discovery under the applicable rules of procedure or 
evidence; or
    (D) Records concerning voluntary employee assistance programs 
(alcohol, drug abuse, or personal counseling programs) if maintained 
separately from the employer's medical program and its records.
    (7) Employer means a current employer, a former employer, or a 
successor employer.
    (8) Exposure or exposed means that an employee is subjected to a 
toxic substance or harmful physical agent in the course of employment 
through any route of entry (inhalation, ingestion, skin contact or 
absorption, etc.), and includes past exposure and potential (e.g., 
accidental or possible) exposure, but does not include situations where 
the employer can demonstrate that the toxic substance or harmful 
physical agent is not used, handled, stored, generated, or present in 
the workplace in any manner different from typical non-occupational 
situations.
    (9) Health Professional means a physician, occupational health 
nurse, industrial hygienist, toxicologist, or epidemiologist, providing 
medical or other occupational health services to exposed employees.
    (10) Record means any item, collection, or grouping of information 
regardless of the form or process by which it is maintained (e.g., paper 
document, microfiche, microfilm, X-ray film, or automated data 
processing).
    (11) Specific chemical identity means the chemical name, Chemical 
Abstracts Service (CAS) Registry Number, or any other information that 
reveals the precise chemical designation of the substance.
    (12)(i) Specific written consent means a written authorization 
containing the following:
    (A) The name and signature of the employee authorizing the release 
of medical information,
    (B) The date of the written authorization,
    (C) The name of the individual or organization that is authorized to 
release the medical information,
    (D) The name of the designated representative (individual or 
organization) that is authorized to receive the released information,
    (E) A general description of the medical information that is 
authorized to be released,
    (F) A general description of the purpose for the release of the 
medical information, and
    (G) A date or condition upon which the written authorization will 
expire (if less than one year).
    (ii) A written authorization does not operate to authorize the 
release of medical information not in existence on the date of written 
authorization, unless the release of future information is expressly 
authorized, and does not operate for more than one year from the date of 
written authorization.

[[Page 94]]

    (iii) A written authorization may be revoked in writing 
prospectively at any time.
    (13) Toxic substance or harmful physical agent means any chemical 
substance, biological agent (bacteria, virus, fungus, etc.), or physical 
stress (noise, heat, cold, vibration, repetitive motion, ionizing and 
non-ionizing radiation, hypo-or hyperbaric pressure, etc.) which:
    (i) Is listed in the latest printed edition of the National 
Institute for Occupational Safety and Health (NIOSH) Registry of Toxic 
Effects of Chemical Substances (RTECS), which is incorporated by 
reference as specified in Sec. 1910.6; or
    (ii) Has yielded positive evidence of an acute or chronic health 
hazard in testing conducted by, or known to, the employer; or
    (iii) Is the subject of a material safety data sheet kept by or 
known to the employer indicating that the material may pose a hazard to 
human health.
    (14) Trade secret means any confidential formula, pattern, process, 
device, or information or compilation of information that is used in an 
employer's business and that gives the employer an opportunity to obtain 
an advantage over competitors who do not know or use it.
    (d) Preservation of records. (1) Unless a specific occupational 
safety and health standard provides a different period of time, each 
employer shall assure the preservation and retention of records as 
follows:
    (i) Employee medical records. The medical record for each employee 
shall be preserved and maintained for at least the duration of 
employment plus thirty (30) years, except that the following types of 
records need not be retained for any specified period:
    (A) Health insurance claims records maintained separately from the 
employer's medical program and its records,
    (B) First aid records (not including medical histories) of one-time 
treatment and subsequent observation of minor scratches, cuts, burns, 
splinters, and the like which do not involve medical treatment, loss of 
consciousness, restriction of work or motion, or transfer to another 
job, if made on-site by a non-physician and if maintained separately 
from the employer's medical program and its records, and
    (C) The medical records of employees who have worked for less than 
(1) year for the employer need not be retained beyond the term of 
employment if they are provided to the employee upon the termination of 
employment.
    (ii) Employee exposure records. Each employee exposure record shall 
be preserved and maintained for at least thirty (30) years, except that:
    (A) Background data to environmental (workplace) monitoring or 
measuring, such as laboratory reports and worksheets, need only be 
retained for one (1) year as long as the sampling results, the 
collection methodology (sampling plan), a description of the analytical 
and mathematical methods used, and a summary of other background data 
relevant to interpretation of the results obtained, are retained for at 
least thirty (30) years; and
    (B) Material safety data sheets and paragraph (c)(5)(iv) records 
concerning the identity of a substance or agent need not be retained for 
any specified period as long as some record of the identity (chemical 
name if known) of the substance or agent, where it was used, and when it 
was used is retained for at least thirty (30) years;\1\ and
---------------------------------------------------------------------------

    \1\ Material safety data sheets must be kept for those chemicals 
currently in use that are effected by the Hazard Communication Standard 
in accordance with 29 CFR 1910.1200(g).
---------------------------------------------------------------------------

    (C) Biological monitoring results designated as exposure records by 
specific occupational safety and health standards shall be preserved and 
maintained as required by the specific standard.
    (iii) Analyses using exposure or medical records. Each analysis 
using exposure or medial records shall be preserved and maintained for 
at least thirty (30) years.
    (2) Nothing in this section is intended to mandate the form, manner, 
or process by which an employer preserves a record as long as the 
information contained in the record is preserved and retrievable, except 
that chest X-ray films shall be preserved in their original state.
    (e) Access to records--(1) General. (i) Whenever an employee or 
designated

[[Page 95]]

representative requests access to a record, the employer shall assure 
that access is provided in a reasonable time, place, and manner. If the 
employer cannot reasonably provide access to the record within fifteen 
(15) working days, the employer shall within the fifteen (15) working 
days apprise the employee or designated representative requesting the 
record of the reason for the delay and the earliest date when the record 
can be made available.
    (ii) The employer may require of the requester only such information 
as should be readily known to the requester and which may be necessary 
to locate or identify the records being requested (e.g. dates and 
locations where the employee worked during the time period in question).
    (iii) Whenever an employee or designated representative requests a 
copy of a record, the employer shall assure that either:
    (A) A copy of the record is provided without cost to the employee or 
representative,
    (B) The necessary mechanical copying facilities (e.g., photocopying) 
are made available without cost to the employee or representative for 
copying the record, or
    (C) The record is loaned to the employee or representative for a 
reasonable time to enable a copy to be made.
    (iv) In the case of an original X-ray, the employer may restrict 
access to on-site examination or make other suitable arrangements for 
the temporary loan of the X-ray.
    (v) Whenever a record has been previously provided without cost to 
an employee or designated representative, the employer may charge 
reasonable, non-discriminatory administrative costs (i.e., search and 
copying expenses but not including overhead expenses) for a request by 
the employee or designated representative for additional copies of the 
record, except that
    (A) An employer shall not charge for an initial request for a copy 
of new information that has been added to a record which was previously 
provided; and
    (B) An employer shall not charge for an initial request by a 
recognized or certified collective bargaining agent for a copy of an 
employee exposure record or an analysis using exposure or medical 
records.
    (vi) Nothing in this section is intended to preclude employees and 
collective bargaining agents from collectively bargaining to obtain 
access to information in addition to that available under this section.
    (2) Employee and designated representative access--(i) Employee 
exposure records. (A) Except as limited by paragraph (f) of this 
section, each employer shall, upon request, assure the access to each 
employee and designated representative to employee exposure records 
relevant to the employee. For the purpose of this section, an exposure 
record relevant to the employee consists of:
    (1) A record which measures or monitors the amount of a toxic 
substance or harmful physical agent to which the employee is or has been 
exposed;
    (2) In the absence of such directly relevant records, such records 
of other employees with past or present job duties or working conditions 
related to or similar to those of the employee to the extent necessary 
to reasonably indicate the amount and nature of the toxic substances or 
harmful physical agents to which the employee is or has been subjected, 
and
    (3) Exposure records to the extent necessary to reasonably indicate 
the amount and nature of the toxic substances or harmful physical agents 
at workplaces or under working conditions to which the employee is being 
assigned or transferred.
    (B) Requests by designated representatives for unconsented access to 
employee exposure records shall be in writing and shall specify with 
reasonable particularity:
    (1) The records requested to be disclosed; and
    (2) The occupational health need for gaining access to these 
records.
    (ii) Employee medical records. (A) Each employer shall, upon 
request, assure the access of each employee to employee medical records 
of which the employee is the subject, except as provided in paragraph 
(e)(2)(ii)(D) of this section.
    (B) Each employer shall, upon request, assure the access of each 
designated representative to the employee

[[Page 96]]

medical records of any employee who has given the designated 
representative specific written consent. Appendix A to this section 
contains a sample form which may be used to establish specific written 
consent for access to employee medical records.
    (C) Whenever access to employee medical records is requested, a 
physician representing the employer may recommend that the employee or 
designated representative:
    (1) Consult with the physician for the purposes of reviewing and 
discussing the records requested,
    (2) Accept a summary of material facts and opinions in lieu of the 
records requested, or
    (3) Accept release of the requested records only to a physician or 
other designated representative.
    (D) Whenever an employee requests access to his or her employee 
medical records, and a physician representing the employer believes that 
direct employee access to information contained in the records regarding 
a specific diagnosis of a terminal illness or a psychiatric condition 
could be detrimental to the employee's health, the employer may inform 
the employee that access will only be provided to a designated 
representative of the employee having specific written consent, and deny 
the employee's request for direct access to this information only. Where 
a designated representative with specific written consent requests 
access to information so withheld, the employer shall assure the access 
of the designated representative to this information, even when it is 
known that the designated representative will give the information to 
the employee.
    (E) A physician, nurse, or other responsible health care personnel 
maintaining medical records may delete from requested medical records 
the identity of a family member, personal friend, or fellow employee who 
has provided confidential information concerning an employee's health 
status.
    (iii) Analyses using exposure or medical records. (A) Each employee 
shall, upon request, assure the access of each employee and designated 
representative to each analysis using exposure or medical records 
concerning the employee's working conditions or workplace.
    (B) Whenever access is requested to an analysis which reports the 
contents of employee medical records by either direct identifier (name, 
address, social security number, payroll number, etc.) or by information 
which could reasonably be used under the circumstances indirectly to 
identify specific employees (exact age, height, weight, race, sex, date 
of initial employment, job title, etc.), the employer shall assure that 
personal identifiers are removed before access is provided. If the 
employer can demonstrate that removal of personal identifiers from an 
analysis is not feasible, access to the personally identifiable portions 
of the analysis need not be provided.
    (3) OSHA access. (i) Each employer shall, upon request, and without 
derogation of any rights under the Constitution or the Occupational 
Safety and Health Act of 1970, 29 U.S.C. 651 et seq., that the employer 
chooses to exercise, assure the prompt access of representatives of the 
Assistant Secretary of Labor for Occupational Safety and Health to 
employee exposure and medical records and to analyses using exposure or 
medical records. Rules of agency practice and procedure governing OSHA 
access to employee medical records are contained in 29 CFR 1913.10.
    (ii) Whenever OSHA seeks access to personally identifiable employee 
medical information by presenting to the employer a written access order 
pursuant to 29 CFR 1913.10(d), the employer shall prominently post a 
copy of the written access order and its accompanying cover letter for 
at least fifteen (15) working days.
    (f) Trade secrets. (1) Except as provided in paragraph (f)(2) of 
this section, nothing in this section precludes an employer from 
deleting from records requested by a health professional, employee, or 
designated representative any trade secret data which discloses 
manufacturing processes, or discloses the percentage of a chemical 
substance in mixture, as long as the health professional, employee, or 
designated representative is notified that information has been deleted. 
Whenever deletion of trade secret information substantially impairs 
evaluation of the place where

[[Page 97]]

or the time when exposure to a toxic substance or harmful physical agent 
occurred, the employer shall provide alternative information which is 
sufficient to permit the requesting party to identify where and when 
exposure occurred.
    (2) The employer may withhold the specific chemical identity, 
including the chemical name and other specific identification of a toxic 
substance from a disclosable record provided that:
    (i) The claim that the information withheld is a trade secret can be 
supported;
    (ii) All other available information on the properties and effects 
of the toxic substance is disclosed;
    (iii) The employer informs the requesting party that the specific 
chemical identity is being withheld as a trade secret; and
    (iv) The specific chemical identity is made available to health 
professionals, employees and designated representatives in accordance 
with the specific applicable provisions of this paragraph.
    (3) Where a treating physician or nurse determines that a medical 
emergency exists and the specific chemical identity of a toxic substance 
is necessary for emergency or first-aid treatment, the employer shall 
immediately disclose the specific chemical identity of a trade secret 
chemical to the treating physician or nurse, regardless of the existence 
of a written statement of need or a confidentiality agreement. The 
employer may require a written statement of need and confidentiality 
agreement, in accordance with the provisions of paragraphs (f)(4) and 
(f)(5), as soon as circumstances permit.
    (4) In non-emergency situations, an employer shall, upon request, 
disclose a specific chemical identity, otherwise permitted to be 
withheld under paragraph (f)(2) of this section, to a health 
professional, employee, or designated representative if:
    (i) The request is in writing;
    (ii) The request describes with reasonable detail one or more of the 
following occupational health needs for the information:
    (A) To assess the hazards of the chemicals to which employees will 
be exposed;
    (B) To conduct or assess sampling of the workplace atmosphere to 
determine employee exposure levels;
    (C) To conduct pre-assignment or periodic medical surveillance of 
exposed employees;
    (D) To provide medical treatment to exposed employees;
    (E) To select or assess appropriate personal protective equipment 
for exposed employees;
    (F) To design or assess engineering controls or other protective 
measures for exposed employees; and
    (G) To conduct studies to determine the health effects of exposure.
    (iii) The request explains in detail why the disclosure of the 
specific chemical identity is essential and that, in lieu thereof, the 
disclosure of the following information would not enable the health 
professional, employee or designated representative to provide the 
occupational health services described in paragraph (f)(4)(ii) of this 
section:
    (A) The properties and effects of the chemical;
    (B) Measures for controlling workers' exposure to the chemical;
    (C) Methods of monitoring and analyzing worker exposure to the 
chemical; and,
    (D) Methods of diagnosing and treating harmful exposures to the 
chemical;
    (iv) The request includes a description of the procedures to be used 
to maintain the confidentiality of the disclosed information; and,
    (v) The health professional, employee, or designated representative 
and the employer or contractor of the services of the health 
professional or designated representative agree in a written 
confidentiality agreement that the health professional, employee or 
designated representative will not use the trade secret information for 
any purpose other than the health need(s) asserted and agree not to 
release the information under any circumstances other than to OSHA, as 
provided in paragraph (f)(7) of this section, except as authorized by 
the terms of the agreement or by the employer.
    (5) The confidentiality agreement authorized by paragraph (f)(4)(iv) 
of this section:

[[Page 98]]

    (i) May restrict the use of the information to the health purposes 
indicated in the written statement of need;
    (ii) May provide for appropriate legal remedies in the event of a 
breach of the agreement, including stipulation of a reasonable pre-
estimate of likely damages; and,
    (iii) May not include requirements for the posting of a penalty 
bond.
    (6) Nothing in this section is meant to preclude the parties from 
pursuing non-contractual remedies to the extent permitted by law.
    (7) If the health professional, employee or designated 
representative receiving the trade secret information decides that there 
is a need to disclose it to OSHA, the employer who provided the 
information shall be informed by the health professional prior to, or at 
the same time as, such disclosure.
    (8) If the employer denies a written request for disclosure of a 
specific chemical identity, the denial must:
    (i) Be provided to the health professional, employee or designated 
representative within thirty days of the request;
    (ii) Be in writing;
    (iii) Include evidence to support the claim that the specific 
chemical identity is a trade secret;
    (iv) State the specific reasons why the request is being denied; 
and,
    (v) Explain in detail how alternative information may satisfy the 
specific medical or occupational health need without revealing the 
specific chemical identity.
    (9) The health professional, employee, or designated representative 
whose request for information is denied under paragraph (f)(4) of this 
section may refer the request and the written denial of the request to 
OSHA for consideration.
    (10) When a heath professional employee, or designated 
representative refers a denial to OSHA under paragraph (f)(9) of this 
section, OSHA shall consider the evidence to determine if:
    (i) The employer has supported the claim that the specific chemical 
identity is a trade secret;
    (ii) The health professional employee, or designated representative 
has supported the claim that there is a medical or occupational health 
need for the information; and
    (iii) The health professional, employee or designated representative 
has demonstrated adequate means to protect the confidentiality.
    (11)(i) If OSHA determines that the specific chemical identity 
requested under paragraph (f)(4) of this section is not a bona fide 
trade secret, or that it is a trade secret but the requesting health 
professional, employee or designated representatives has a legitimate 
medical or occupational health need for the information, has executed a 
written confidentiality agreement, and has shown adequate means for 
complying with the terms of such agreement, the employer will be subject 
to citation by OSHA.
    (ii) If an employer demonstrates to OSHA that the execution of a 
confidentiality agreement would not provide sufficient protection 
against the potential harm from the unauthorized disclosure of a trade 
secret specific chemical identity, the Assistant Secretary may issue 
such orders or impose such additional limitations or conditions upon the 
disclosure of the requested chemical information as may be appropriate 
to assure that the occupational health needs are met without an undue 
risk of harm to the employer.
    (12) Notwithstanding the existence of a trade secret claim, an 
employer shall, upon request, disclose to the Assistant Secretary any 
information which this section requires the employer to make available. 
Where there is a trade secret claim, such claim shall be made no later 
than at the time the information is provided to the Assistant Secretary 
so that suitable determinations of trade secret status can be made and 
the necessary protections can be implemented.
    (13) Nothing in this paragraph shall be construed as requiring the 
disclosure under any circumstances of process or percentage of mixture 
information which is trade secret.
    (g) Employee information. (1) Upon an employee's first entering into 
employment, and at least annually thereafter, each employer shall inform 
current employees covered by this section of the following:

[[Page 99]]

    (i) The existence, location, and availability of any records covered 
by this section;
    (ii) The person responsible for maintaining and providing access to 
records; and
    (iii) Each employee's rights of access to these records.
    (2) Each employer shall keep a copy of this section and its 
appendices, and make copies readily available, upon request, to 
employees. The employer shall also distribute to current employees any 
informational materials concerning this section which are made available 
to the employer by the Assistant Secretary of Labor for Occupational 
Safety and Health.
    (h) Transfer of records. (1) Whenever an employer is ceasing to do 
business, the employer shall transfer all records subject to this 
section to the successor employer. The successor employer shall receive 
and maintain these records.
    (2) Whenever an employer is ceasing to do business and there is no 
successor employer to receive and maintain the records subject to this 
standard, the employer shall notify affected current employees of their 
rights of access to records at least three (3) months prior to the 
cessation of the employer's business.
    (3) Whenever an employer either is ceasing to do business and there 
is no successor employer to receive and maintain the records, or intends 
to dispose of any records required to be preserved for at least thirty 
(30) years, the employer shall:
    (i) Transfer the records to the Director of the National Institute 
for Occupational Safety and Health (NIOSH) if so required by a specific 
occupational safety and health standard; or
    (ii) Notify the Director of NIOSH in writing of the impending 
disposal of records at least three (3) months prior to the disposal of 
the records.
    (4) Where an employer regularly disposes of records required to be 
preserved for at least thirty (30) years, the employer may, with at 
least (3) months notice, notify the Director of NIOSH on an annual basis 
of the records intended to be disposed of in the coming year.
    (i) Appendices. The information contained in appendices A and B to 
this section is not intended, by itself, to create any additional 
obligations not otherwise imposed by this section nor detract from any 
existing obligation.

   Appendix A to Sec. 1910.1020--Sample Authorization Letter for the 
     Release of Employee Medical Record Information to a Designated 
                     Representative (Non-Mandatory)

    I, ---------- (full name of worker/patient), hereby authorize ------
------ (individual or organization holding the medical records) to 
release to ------------ (individual or organization authorized to 
receive the medical information), the following medical information from 
my personal medical records:
________________________________________________________________________
________________________________________________________________________
(Describe generally the information desired to be released)
    I give my permission for this medical information to be used for the 
following purpose:
________________________________________________________________________
________________________________________________________________________
but I do not give permission for any other use or re-disclosure of this 
information.

    Note: Several extra lines are provided below so that you can place 
additional restrictions on this authorization letter if you want to. You 
may, however, leave these lines blank. On the other hand, you may want 
to (1) specify a particular expiration date for this letter (if less 
than one year); (2) describe medical information to be created in the 
future that you intend to be covered by this authorization letter; or 
(3) describe portions of the medical information in your records which 
you do not intend to be released as a result of this letter.)

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

________________________________________________________________________
Full name of Employee or Legal Representative
________________________________________________________________________
Signature of Employee or Legal Representative
________________________________________________________________________
________________________________________________________________________
Date of Signature

 Appendix B to Sec. 1910.1020--Availability of NIOSH Registry of Toxic 
         Effects of Chemical Substances (RTECS) (Non-Mandatory)

    The final regulation, 29 CFR 1910.20, applies to all employee 
exposure and medical records, and analyses thereof, of employees exposed 
to toxic substances or harmful physical agents (paragraph (b)(2)). The 
term toxic substance or harmful physical agent is defined

[[Page 100]]

by paragraph (c)(13) to encompass chemical substances, biological 
agents, and physical stresses for which there is evidence of harmful 
health effects. The regulation uses the latest printed edition of the 
National Institute for Occupational Safety and Health (NIOSH) Registry 
of Toxic Effects of Chemical Substances (RTECS) as one of the chief 
sources of information as to whether evidence of harmful health effects 
exists. If a substance is listed in the latest printed RTECS, the 
regulation applies to exposure and medical records (and analyses of 
these records) relevant to employees exposed to the substance.
    It is appropriate to note that the final regulation does not require 
that employers purchase a copy of RTECS, and many employers need not 
consult RTECS to ascertain whether their employee exposure or medical 
records are subject to the rule. Employers who do not currently have the 
latest printed edition of the NIOSH RTECS, however, may desire to obtain 
a copy. The RTECS is issued in an annual printed edition as mandated by 
section 20(a)(6) of the Occupational Safety and Health Act (29 U.S.C. 
669(a)(6)).
    The Introduction to the 1980 printed edition describes the RTECS as 
follows:
    ``The 1980 edition of the Registry of Toxic Effects of Chemical 
Substances, formerly known as the Toxic Substances list, is the ninth 
revision prepared in compliance with the requirements of Section 
20(a)(6) of the Occupational Safety and Health Act of 1970 (Public Law 
91-596). The original list was completed on June 28, 1971, and has been 
updated annually in book format. Beginning in October 1977, quarterly 
revisions have been provided in microfiche. This edition of the Registry 
contains 168,096 listings of chemical substances: 45,156 are names of 
different chemicals with their associated toxicity data and 122,940 are 
synonyms. This edition includes approximately 5,900 new chemical 
compounds that did not appear in the 1979 Registry. (p. xi)
    ``The Registry's purposes are many, and it serves a variety of 
users. It is a single source document for basic toxicity information and 
for other data, such as chemical identifiers ad information necessary 
for the preparation of safety directives and hazard evaluations for 
chemical substances. The various types of toxic effects linked to 
literature citations provide researchers and occupational health 
scientists with an introduction to the toxicological literature, making 
their own review of the toxic hazards of a given substance easier. By 
presenting data on the lowest reported doses that produce effects by 
several routes of entry in various species, the Registry furnishes 
valuable information to those responsible for preparing safety data 
sheets for chemical substances in the workplace. Chemical and production 
engineers can use the Registry to identify the hazards which may be 
associated with chemical intermediates in the development of final 
products, and thus can more readily select substitutes or alternative 
processes which may be less hazardous. Some organizations, including 
health agencies and chemical companies, have included the NIOSH Registry 
accession numbers with the listing of chemicals in their files to 
reference toxicity information associated with those chemicals. By 
including foreign language chemical names, a start has been made toward 
providing rapid identification of substances produced in other 
countries. (p. xi)
    ``In this edition of the Registry, the editors intend to identify 
``all known toxic substances'' which may exist in the environment and to 
provide pertinent data on the toxic effects from known doses entering an 
organism by any route described. (p xi)
    ``It must be reemphasized that the entry of a substance in the 
Registry does not automatically mean that it must be avoided. A listing 
does mean, however, that the substance has the documented potential of 
being harmful if misused, and care must be exercised to prevent tragic 
consequences. Thus, the Registry lists many substances that are common 
in everyday life and are in nearly every household in the United States. 
One can name a variety of such dangerous substances: prescription and 
non-prescription drugs; food additives; pesticide concentrates, sprays, 
and dusts; fungicides; herbicides; paints; glazes, dyes; bleaches and 
other household cleaning agents; alkalies; and various solvents and 
diluents. The list is extensive because chemicals have become an 
integral part of our existence.''
    The RTECS printed edition may be purchased from the Superintendent 
of Documents, U.S. Government Printing Office (GPO), Washington, DC 
20402 (202-783-3238).
    Some employers may desire to subscribe to the quarterly update to 
the RTECS which is published in a microfiche edition. An annual 
subscription to the quarterly microfiche may be purchased from the GPO 
(Order the ``Microfiche Edition, Registry of Toxic Effects of Chemical 
Substances''). Both the printed edition and the microfiche edition of 
RTECS are available for review at many university and public libraries 
throughout the country. The latest RTECS editions may also be examined 
at the OSHA Technical Data Center, Room N2439--Rear, United States 
Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210 
(202-523-9700), or at any OSHA Regional or Area Office (See, major city 
telephone directories

[[Page 101]]

under United States Government-Labor Department).

[53 FR 38163, Sept. 29, 1988; 53 FR 49981, Dec. 13, 1988, as amended at 
54 FR 24333, June 7, 1989; 55 FR 26431, June 28, 1990; 61 FR 9235, Mar. 
7, 1996. Redesignated at 61 FR 31430, June 20, 1996, as amended at 71 FR 
16673, Apr. 3, 2006]



Sec. 1910.1025  Lead.

    (a) Scope and application. (1) This section applies to all 
occupational exposure to lead, except as provided in paragraph (a)(2).
    (2) This section does not apply to the construction industry or to 
agricultural operations covered by 29 CFR Part 1928.
    (b) Definitions. Action level means employee exposure, without 
regard to the use of respirators, to an airborne concentration of lead 
of 30 micrograms per cubic meter of air (30 [micro]g/m\3\) averaged over 
an 8-hour period.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Director means the Director, National Institute for Occupational 
Safety and Health (NIOSH), U.S. Department of Health, Education, and 
Welfare, or designee.
    Lead means metallic lead, all inorganic lead compounds, and organic 
lead soaps. Excluded from this definition are all other organic lead 
compounds.
    (c) Permissible exposure limit (PEL). (1) The employer shall assure 
that no employee is exposed to lead at concentrations greater than fifty 
micrograms per cubic meter of air (50 [micro]g/m\3\) averaged over an 8-
hour period.
    (2) If an employee is exposed to lead for more than 8 hours in any 
work day, the permissible exposure limit, as a time weighted average 
(TWA) for that day, shall be reduced according to the following formula:

  Maximum permissible limit (in [micro]g/m\3\)=400/hours worked in the 
                                  day.

    (3) When respirators are used to supplement engineering and work 
practice controls to comply with the PEL and all the requirements of 
paragraph (f) have been met, employee exposure, for the purpose of 
determining whether the employer has complied with the PEL, may be 
considered to be at the level provided by the protection factor of the 
respirator for those periods the respirator is worn. Those periods may 
be averaged with exposure levels during periods when respirators are not 
worn to determine the employee's daily TWA exposure.
    (d) Exposure monitoring--(1) General. (i) For the purposes of 
paragraph (d), employee exposure is that exposure which would occur if 
the employee were not using a respirator.
    (ii) With the exception of monitoring under paragraph (d)(3), the 
employer shall collect full shift (for at least 7 continuous hours) 
personal samples including at least one sample for each shift for each 
job classification in each work area.
    (iii) Full shift personal samples shall be representative of the 
monitored employee's regular, daily exposure to lead.
    (2) Initial determination. Each employer who has a workplace or work 
operation covered by this standard shall determine if any exployee may 
be exposed to lead at or above the action level.
    (3) Basis of initial determination. (i) The employer shall monitor 
employee exposures and shall base initial determinations on the employee 
exposure monitoring results and any of the following, relevant 
considerations:
    (A) Any information, observations, or calculations which would 
indicate employee exposure to lead;
    (B) Any previous measurements of airborne lead; and
    (C) Any employee complaints of symptoms which may be attributable to 
exposure to lead.
    (ii) Monitoring for the initial determination may be limited to a 
representative sample of the exposed employees who the employer 
reasonably believes are exposed to the greatest airborne concentrations 
of lead in the workplace.
    (iii) Measurements of airborne lead made in the preceding 12 months 
may be used to satisfy the requirement to monitor under paragraph 
(d)(3)(i) if the sampling and analytical methods used meet the accuracy 
and confidence levels of paragraph (d)(9) of this section.

[[Page 102]]

    (4) Positive initial determination and initial monitoring. (i) Where 
a determination conducted under paragraphs (d) (2) and (3) of this 
section shows the possibility of any employee exposure at or above the 
action level, the employer shall conduct monitoring which is 
representative of the exposure for each employee in the workplace who is 
exposed to lead.
    (ii) Measurements of airborne lead made in the preceding 12 months 
may be used to satisfy this requirement if the sampling and analytical 
methods used meet the accuracy and confidence levels of paragraph (d)(9) 
of this section.
    (5) Negative initial determination. Where a determination, conducted 
under paragraphs (d) (2) and (3) of this section is made that no 
employee is exposed to airborne concentrations of lead at or above the 
action level, the employer shall make a written record of such 
determination. The record shall include at least the information 
specified in paragraph (d)(3) of this section and shall also include the 
date of determination, location within the worksite, and the name and 
social security number of each employee monitored.
    (6) Frequency. (i) If the initial monitoring reveals employee 
exposure to be below the action level the measurements need not be 
repeated except as otherwise provided in paragraph (d)(7) of this 
section.
    (ii) If the initial determination or subsequent monitoring reveals 
employee exposure to be at or above the action level but below the 
permissible exposure limit the employer shall repeat monitoring in 
accordance with this paragraph at least every 6 months. The employer 
shall continue monitoring at the required frequency until at least two 
consecutive measurements, taken at least 7 days apart, are below the 
action level at which time the employer may discontinue monitoring for 
that employee except as otherwise provided in paragraph (d)(7) of this 
section.
    (iii) If the initial monitoring reveals that employee exposure is 
above the permissible exposure limit the employer shall repeat 
monitoring quarterly. The employer shall continue monitoring at the 
required frequency until at least two consecutive measurements, taken at 
least 7 days apart, are below the PEL but at or above the action level 
at which time the employer shall repeat monitoring for that employee at 
the frequency specified in paragraph (d)(6)(ii), except as otherwise 
provided in paragraph (d)(7) of this section.
    (7) Additional monitoring. Whenever there has been a production, 
process, control or personnel change which may result in new or 
additional exposure to lead, or whenever the employer has any other 
reason to suspect a change which may result in new or additional 
exposures to lead, additional monitoring in accordance with this 
paragraph shall be conducted.
    (8) Employee notification. (i) The employer must, within 15 working 
days after the receipt of the results of any monitoring performed under 
this section, notify each affected employee of these results either 
individually in writing or by posting the results in an appropriate 
location that is accessible to affected employees.
    (ii) Whenever the results indicate that the representative employee 
exposure, without regard to respirators, exceeds the permissible 
exposure limit, the employer shall incude in the written notice a 
statement that the permissible exposure limit was exceeded and a 
description of the corrective action taken or to be taken to reduce 
exposure to or below the permissible exposure limit.
    (9) Accuracy of measurement. The employer shall use a method of 
monitoring and analysis which has an accuracy (to a confidence level of 
95%) of not less than plus or minus 20 percent for airborne 
concentrations of lead equal to or greater than 30 [micro]g/m\3\.
    (e) Methods of compliance--(1) Engineering and work practice 
controls. (i) Where any employee is exposed to lead above the 
permissible exposure limit for more than 30 days per year, the employer 
shall implement engineering and work practice controls (including 
administrative controls) to reduce and maintain employee exposure to 
lead in accordance with the implementation schedule in Table I below, 
except to the

[[Page 103]]

extent that the employer can demonstrate that such controls are not 
feasible. Wherever the engineering and work practice controls which can 
be instituted are not sufficient to reduce employee exposure to or below 
the permissible exposure limit, the employer shall nonetheless use them 
to reduce exposures to the lowest feasible level and shall supplement 
them by the use of respiratory protection which complies with the 
requirements of paragraph (f) of this section.
    (ii) Where any employee is exposed to lead above the permissible 
exposure limit, but for 30 days or less per year, the employer shall 
implement engineering controls to reduce exposures to 200 [micro]g/m\3\, 
but thereafter may implement any combination of engineering, work 
practice (including administrative controls), and respiratory controls 
to reduce and maintain employee exposure to lead to or below 50 
[micro]g/m\3\.

                                 Table I
------------------------------------------------------------------------
                                             Compliance dates: \1\ (50
                 Industry                          [micro]g/m\3\)
------------------------------------------------------------------------
Lead chemicals, secondary copper smelting  July 19, 1996.
Nonferrous foundries.....................  July 19, 1996. \2\
Brass and bronze ingot manufacture.......  6 years. \3\
------------------------------------------------------------------------
\1\ Calculated by counting from the date the stay on implementation of
  paragraph (e)(1) was lifted by the U.S. Court of Appeals for the
  District of Columbia, the number of years specified in the 1978 lead
  standard and subsequent amendments for compliance with the PEL of 50
  [micro]g/m\3\ for exposure to airborne concentrations of lead levels
  for the particular industry.
\2\ Large nonferrous foundries (20 or more employees) are required to
  achieve the PEL of 50 [micro]g/m\3\ by means of engineering and work
  practice controls. Small nonferrous foundries (fewer than 20
  employees) are required to achieve an 8-hour TWA of 75 [micro]g/m\3\
  by such controls.
\3\ Expressed as the number of years from the date on which the Court
  lifts the stay on the implementation of paragraph (e)(1) for this
  industry for employers to achieve a lead in air concentration of 75
  [micro]g/m\3\. Compliance with paragraph (e) in this industry is
  determined by a compliance directive that incorporates elements from
  the settlement agreement between OSHA and representatives of the
  industry.

    (2) Respiratory protection. Where engineering and work practice 
controls do not reduce employee exposure to or below the 50 [micro]g/
m\3\ permissible exposure limit, the employer shall supplement these 
controls with respirators in accordance with paragraph (f).
    (3) Compliance program. (i) Each employer shall establish and 
implement a written compliance program to reduce exposures to or below 
the permissible exposure limit, and interim levels if applicable, solely 
by means of engineering and work practice controls in accordance with 
the implementation schedule in paragraph (e)(1).
    (ii) Written plans for these compliance programs shall include at 
least the following:
    (A) A description of each operation in which lead is emitted; e.g. 
machinery used, material processed, controls in place, crew size, 
employee job responsibilities, operating procedures and maintenance 
practices;
    (B) A description of the specific means that will be employed to 
achieve compliance, including engineering plans and studies used to 
determine methods selected for controlling exposure to lead;
    (C) A report of the technology considered in meeting the permissible 
exposure limit;
    (D) Air monitoring data which documents the source of lead 
emissions;
    (E) A detailed schedule for implementation of the program, including 
documentation such as copies of purchase orders for equipment, 
construction contracts, etc.;
    (F) A work practice program which includes items required under 
paragraphs (g), (h) and (i) of this regulation;
    (G) An administrative control schedule required by paragraph (e)(6), 
if applicable;
    (H) Other relevant information.
    (iii) Written programs shall be submitted upon request to the 
Assistant Secretary and the Director, and shall be available at the 
worksite for examination and copying by the Assistant Secretary, 
Director, any affected employee or authorized employee representatives.
    (iv) Written programs must be revised and updated at least annually 
to reflect the current status of the program.
    (4) Mechanical ventilation. (i) When ventilation is used to control 
exposure, measurements which demonstrate the effectiveness of the system 
in controlling exposure, such as capture velocity, duct velocity, or 
static pressure shall be made at least every 3 months. Measurements of 
the system's effectiveness in controlling exposure shall be made within 
5 days of any change in production, process, or control which might

[[Page 104]]

result in a change in employee exposure to lead.
    (ii) Recirculation of air. If air from exhaust ventilation is 
recirculated into the workplace, the employer shall assure that (A) the 
system has a high efficiency filter with reliable back-up filter; and 
(B) controls to monitor the concentration of lead in the return air and 
to bypass the recirculation system automatically if it fails are 
installed, operating, and maintained.
    (5) Administrative controls. If administrative controls are used as 
a means of reducing employees TWA exposure to lead, the employer shall 
establish and implement a job rotation schedule which includes:
    (i) Name or identification number of each affected employee;
    (ii) Duration and exposure levels at each job or work station where 
each affected employee is located; and
    (iii) Any other information which may be useful in assessing the 
reliability of administrative controls to reduce exposure to lead.
    (f) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer must provide each 
employee an appropriate respirator that complies with the requirements 
of this paragraph. Respirators must be used during:
    (i) Periods necessary to install or implement engineering or work-
practice controls.
    (ii) Work operations for which engineering and work-practice 
controls are not sufficient to reduce employee exposures to or below the 
permissible exposure limit.
    (iii) Periods when an employee requests a respirator.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with Sec. 1910.134(b) 
through (d) (except (d)(1)(iii)), and (f) through (m), which covers each 
employee required by this section to use a respirator.
    (ii) If an employee has breathing difficulty during fit testing or 
respirator use, the employer must provide the employee with a medical 
examination in accordance with paragraph (j)(3)(i)(C) of this section to 
determine whether or not the employee can use a respirator while 
performing the required duty.
    (3) Respirator selection. (i) Employers must:
    (A) Select, and provide to employees, the appropriate respirators 
specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134.
    (B) Provide employees with full facepiece respirators instead of 
half mask respirators for protection against lead aerosols that cause 
eye or skin irritation at the use concentrations.
    (C) Provide HEPA filters for powered and non-powered air-purifying 
respirators.
    (ii) Employers must provide employees with a powered air-purifying 
respirator (PAPR) instead of a negative pressure respirator selected 
according to paragraph (f)(3)(i) of this standard when an employee 
chooses to use a PAPR and it provides adequate protection to the 
employee as specified by paragraph (f)(3)(i) of this standard.
    (g) Protective work clothing and equipment--(1) Provision and use. 
If an employee is exposed to lead above the PEL, without regard to the 
use of respirators or where the possibility of skin or eye irritation 
exists, the employer shall provide at no cost to the employee and assure 
that the employee uses appropriate protective work clothing and 
equipment such as, but not limited to:
    (i) Coveralls or similar full-body work clothing;
    (ii) Gloves, hats, and shoes or disposable shoe coverlets; and
    (iii) Face shields, vented goggles, or other appropriate protective 
equipment which complies with Sec. 1910.133 of this Part.
    (2) Cleaning and replacement. (i) The employer shall provide the 
protective clothing required in paragraph (g)(1) of this section in a 
clean and dry condition at least weekly, and daily to employees whose 
exposure levels without regard to a respirator are over 200 [micro]g/
m\3\ of lead as an 8-hour TWA.
    (ii) The employer shall provide for the cleaning, laundering, or 
disposal of protective clothing and equipment required by paragraph 
(g)(1) of this section.
    (iii) The employer shall repair or replace required protective 
clothing and equipment as needed to maintain their effectiveness.

[[Page 105]]

    (iv) The employer shall assure that all protective clothing is 
removed at the completion of a work shift only in change rooms provided 
for that purpose as prescribed in paragraph (i)(2) of this section.
    (v) The employer shall assure that contaminated protective clothing 
which is to be cleaned, laundered, or disposed of, is placed in a closed 
container in the change-room which prevents dispersion of lead outside 
the container.
    (vi) The employer shall inform in writing any person who cleans or 
launders protective clothing or equipment of the potentially harmful 
effects of exposure to lead.
    (vii) The employer shall assure that the containers of contaminated 
protective clothing and equipment required by paragraph (g)(2)(v) are 
labelled as follows:

CAUTION: CLOTHING CONTAMINATED WITH LEAD. DO NOT REMOVE DUST BY BLOWING 
OR SHAKING. DISPOSE OF LEAD CONTAMINATED WASH WATER IN ACCORDANCE WITH 
APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.

    (viii) The employer shall prohibit the removal of lead from 
protective clothing or equipment by blowing, shaking, or any other means 
which disperses lead into the air.
    (h) Housekeeping--(1) Surfaces. All surfaces shall be maintained as 
free as practicable of accumulations of lead.
    (2) Cleaning floors. (i) Floors and other surfaces where lead 
accumulates may not be cleaned by the use of compressed air.
    (ii) Shoveling, dry or wet sweeping, and brushing may be used only 
where vacuuming or other equally effective methods have been tried and 
found not to be effective.
    (3) Vacuuming. Where vacuuming methods are selected, the vacuums 
shall be used and emptied in a manner which minimizes the reentry of 
lead into the workplace.
    (i) Hygiene facilities and practices. (1) The employer shall assure 
that in areas where employees are exposed to lead above the PEL, without 
regard to the use of respirators, food or beverage is not present or 
consumed, tobacco products are not present or used, and cosmetics are 
not applied, except in change rooms, lunchrooms, and showers required 
under paragraphs (i)(2) through (i)(4) of this section.
    (2) Change rooms. (i) The employer shall provide clean change rooms 
for employees who work in areas where their airborne exposure to lead is 
above the PEL, without regard to the use of respirators.
    (ii) The employer shall assure that change rooms are equipped with 
separate storage facilities for protective work clothing and equipment 
and for street clothes which prevent cross-contamination.
    (3) Showers. (i) The employer shall assure that employees who work 
in areas where their airborne exposure to lead is above the PEL, without 
regard to the use of respirators, shower at the end of the work shift.
    (ii) The employer shall provide shower facilities in accordance with 
Sec. 1910.141 (d)(3) of this part.
    (iii) The employer shall assure that employees who are required to 
shower pursuant to paragraph (i)(3)(i) do not leave the workplace 
wearing any clothing or equipment worn during the work shift.
    (4) Lunchrooms. (i) The employer shall provide lunchroom facilities 
for employees who work in areas where their airborne exposure to lead is 
above the PEL, without regard to the use of respirators.
    (ii) The employer shall assure that lunchroom facilities have a 
temperature controlled, positive pressure, filtered air supply, and are 
readily accessible to employees.
    (iii) The employer shall assure that employees who work in areas 
where their airborne exposure to lead is above the PEL without regard to 
the use of a respirator wash their hands and face prior to eating, 
drinking, smoking or applying cosmetics.
    (iv) The employer shall assure that employees do not enter lunchroom 
facilities with protective work clothing or equipment unless surface 
lead dust has been removed by vacuuming, downdraft booth, or other 
cleaning method.
    (5) Lavatories. The employer shall provide an adequate number of 
lavatory facilities which comply with Sec. 1910.141(d) (1) and (2) of 
this part.

[[Page 106]]

    (j) Medical surveillance--(1) General. (i) The employer shall 
institute a medical surveillance program for all employees who are or 
may be exposed above the action level for more than 30 days per year.
    (ii) The employer shall assure that all medical examinations and 
procedures are performed by or under the supervision of a licensed 
physician.
    (iii) The employer shall provide the required medical surveillance 
including multiple physician review under paragraph (j)(3)(iii) without 
cost to employees and at a reasonable time and place.
    (2) Biological monitoring--(i) Blood lead and ZPP level sampling and 
analysis. The employer shall make available biological monitoring in the 
form of blood sampling and analysis for lead and zinc protoporphyrin 
levels to each employee covered under paragraph (j)(1)(i) of this 
section on the following schedule:
    (A) At least every 6 months to each employee covered under paragraph 
(j)(1)(i) of this section;
    (B) At least every two months for each employee whose last blood 
sampling and analysis indicated a blood lead level at or above 40 
[micro]g/100 g of whole blood. This frequency shall continue until two 
consecutive blood samples and analyses indicate a blood lead level below 
40 [micro]g/100 g of whole blood; and
    (C) At least monthly during the removal period of each employee 
removed from exposure to lead due to an elevated blood lead level.
    (ii) Follow-up blood sampling tests. Whenever the results of a blood 
lead level test indicate that an employee's blood lead level exceeds the 
numerical criterion for medical removal under paragraph (k)(1)(i)(A) of 
this section, the employer shall provide a second (follow-up) blood 
sampling test within two weeks after the employer receives the results 
of the first blood sampling test.
    (iii) Accuracy of blood lead level sampling and analysis. Blood lead 
level sampling and analysis provided pursuant to this section shall have 
an accuracy (to a confidence level of 95 percent) within plus or minus 
15 percent or 6 [micro]g/100ml, whichever is greater, and shall be 
conducted by a laboratory licensed by the Center for Disease Control, 
United States Department of Health, Education and Welfare (CDC) or which 
has received a satisfactory grade in blood lead proficiency testing from 
CDC in the prior twelve months.
    (iv) Employee notification. Within five working days after the 
receipt of biological monitoring results, the employer shall notify in 
writing each employee whose blood lead level exceeds 40 [micro]g/100 g: 
(A) of that employee's blood lead level and (B) that the standard 
requires temporary medical removal with Medical Removal Protection 
benefits when an employee's blood lead level exceeds the numerical 
criterion for medical removal under paragraph (k)(1)(i) of this section.
    (3) Medical examinations and consultations--(i) Frequency. The 
employer shall make available medical examinations and consultations to 
each employee covered under paragraph (j)(1)(i) of this section on the 
following schedule:
    (A) At least annually for each employee for whom a blood sampling 
test conducted at any time during the preceding 12 months indicated a 
blood lead level at or above 40 [micro]g/100 g;
    (B) Prior to assignment for each employee being assigned for the 
first time to an area in which airborne concentrations of lead are at or 
above the action level;
    (C) As soon as possible, upon notification by an employee either 
that the employee has developed signs or symptoms commonly associated 
with lead intoxication, that the employee desires medical advice 
concerning the effects of current or past exposure to lead on the 
employee's ability to procreate a healthy child, or that the employee 
has demonstrated difficulty in breathing during a respirator fitting 
test or during use; and
    (D) As medically appropriate for each employee either removed from 
exposure to lead due to a risk of sustaining material impairment to 
health, or otherwise limited pursuant to a final medical determination.
    (ii) Content. Medical examinations made available pursuant to 
paragraph (j)(3)(i) (A) through (B) of this section shall include the 
following elements:

[[Page 107]]

    (A) A detailed work history and a medical history, with particular 
attention to past lead exposure (occupational and non-occupational), 
personal habits (smoking, hygiene), and past gastrointestinal, 
hematologic, renal, cardiovascular, reproductive and neurological 
problems;
    (B) A thorough physical examination, with particular attention to 
teeth, gums, hematologic, gastrointestinal, renal, cardiovascular, and 
neurological systems. Pulmonary status should be evaluated if 
respiratory protection will be used;
    (C) A blood pressure measurement;
    (D) A blood sample and analysis which determines:
    (1) Blood lead level;
    (2) Hemoglobin and hematocrit determinations, red cell indices, and 
examination of peripheral smear morphology;
    (3) Zinc protoporphyrin;
    (4) Blood urea nitrogen; and,
    (5) Serum creatinine;
    (E) A routine urinalysis with microscopic examination; and
    (F) Any laboratory or other test which the examining physician deems 
necessary by sound medical practice.

The content of medical examinations made available pursuant to paragraph 
(j)(3)(i) (C) through (D) of this section shall be determined by an 
examining physician and, if requested by an employee, shall include 
pregnancy testing or laboratory evaluation of male fertility.
    (iii) Multiple physician review mechanism. (A) If the employer 
selects the initial physician who conducts any medical examination or 
consultation provided to an employee under this section, the employee 
may designate a second physician:
    (1) To review any findings, determinations or recommendations of the 
initial physician; and
    (2) To conduct such examinations, consultations, and laboratory 
tests as the second physician deems necessary to facilitate this review.
    (B) The employer shall promptly notify an employee of the right to 
seek a second medical opinion after each occasion that an initial 
physician conducts a medical examination or consultation pursuant to 
this section. The employer may condition its participation in, and 
payment for, the multiple physician review mechanism upon the employee 
doing the following within fifteen (15) days after receipt of the 
foregoing notification, or receipt of the initial physician's written 
opinion, whichever is later:
    (1) The employee informing the employer that he or she intends to 
seek a second medical opinion, and
    (2) The employee initiating steps to make an appointment with a 
second physician.
    (C) If the findings, determinations or recommendations of the second 
physician differ from those of the initial physician, then the employer 
and the employee shall assure that efforts are made for the two 
physicians to resolve any disagreement.
    (D) If the two physicians have been unable to quickly resolve their 
disagreement, then the employer and the employee through their 
respective physicians shall designate a third physician:
    (1) To review any findings, determinations or recommendations of the 
prior physicians; and
    (2) To conduct such examinations, consultations, laboratory tests 
and discussions with the prior physicians as the third physician deems 
necessary to resolve the disagreement of the prior physicians.
    (E) The employer shall act consistent with the findings, 
determinations and recommendations of the third physician, unless the 
employer and the employee reach an agreement which is otherwise 
consistent with the recommendations of at least one of the three 
physicians.
    (iv) Information provided to examining and consulting physicians. 
(A) The employer shall provide an initial physician conducting a medical 
examination or consultation under this section with the following 
information:
    (1) A copy of this regulation for lead including all Appendices;
    (2) A description of the affected employee's duties as they relate 
to the employee's exposure;
    (3) The employee's exposure level or anticipated exposure level to 
lead and to any other toxic substance (if applicable);

[[Page 108]]

    (4) A description of any personal protective equipment used or to be 
used;
    (5) Prior blood lead determinations; and
    (6) All prior written medical opinions concerning the employee in 
the employer's possession or control.
    (B) The employer shall provide the foregoing information to a second 
or third physician conducting a medical examination or consultation 
under this section upon request either by the second or third physician, 
or by the employee.
    (v) Written medical opinions. (A) The employer shall obtain and 
furnish the employee with a copy of a written medical opinion from each 
examining or consulting physician which contains the following 
information:
    (1) The physician's opinion as to whether the employee has any 
detected medical condition which would place the employee at increased 
risk of material impairment of the employee's health from exposure to 
lead;
    (2) Any recommended special protective measures to be provided to 
the employee, or limitations to be placed upon the employee's exposure 
to lead;
    (3) Any recommended limitation upon the employee's use of 
respirators, including a determination of whether the employee can wear 
a powered air purifying respirator if a physician determines that the 
employee cannot wear a negative pressure respirator; and
    (4) The results of the blood lead determinations.
    (B) The employer shall instruct each examining and consulting 
physician to:
    (1) Not reveal either in the written opinion, or in any other means 
of communication with the employer, findings, including laboratory 
results, or diagnoses unrelated to an employee's occupational exposure 
to lead; and
    (2) Advise the employee of any medical condition, occupational or 
nonoccupational, which dictates further medical examination or 
treatment.
    (vi) Alternate Physician Determination Mechanisms. The employer and 
an employee or authorized employee representative may agree upon the use 
of any expeditious alternate physician determination mechanism in lieu 
of the multiple physician review mechanism provided by this paragraph so 
long as the alternate mechanism otherwise satisfies the requirements 
contained in this paragraph.
    (4) Chelation. (i) The employer shall assure that any person whom he 
retains, employs, supervises or controls does not engage in prophylactic 
chelation of any employee at any time.
    (ii) If therapeutic or diagnostic chelation is to be performed by 
any person in paragraph (j)(4)(i), the employer shall assure that it be 
done under the supervision of a licensed physician in a clinical setting 
with thorough and appropriate medical monitoring and that the employee 
is notified in writing prior to its occurrence.
    (k) Medical Removal Protection--(1) Temporary medical removal and 
return of an employee--(i) Temporary removal due to elevated blood lead 
levels. (A) The employer shall remove an employee from work having an 
exposure to lead at or above the action level on each occasion that a 
periodic and a follow-up blood sampling test conducted pursuant to this 
section indicate that the employee's blood lead level is at or above 60 
[micro]g/100 g of whole blood; and
    (B) The employer shall remove an employee from work having an 
exposure to lead at or above the action level on each occasion that the 
average of the last three blood sampling tests conducted pursuant to 
this section (or the average of all blood sampling tests conducted over 
the previous six (6) months, whichever is longer) indicates that the 
employee's blood lead level is at or above 50 [micro]g/100 g of whole 
blood; provided, however, that an employee need not be removed if the 
last blood sampling test indicates a blood lead level at or below 40 
[micro]g/100 g of whole blood.
    (ii) Temporary removal due to a final medical determination. (A) The 
employer shall remove an employee from work having an exposure to lead 
at or above the action level on each occasion that a final medical 
determination results in a medical finding, determination, or opinion 
that the employee has a detected medical condition which places the 
employee at increased risk of material impairment to health from 
exposure to lead.

[[Page 109]]

    (B) For the purposes of this section, the phrase ``final medical 
determination'' shall mean the outcome of the multiple physician review 
mechanism or alternate medical determination mechanism used pursuant to 
the medical surveillance provisions of this section.
    (C) Where a final medical determination results in any recommended 
special protective measures for an employee, or limitations on an 
employee's exposure to lead, the employer shall implement and act 
consistent with the recommendation.
    (iii) Return of the employee to former job status. (A) The employer 
shall return an employee to his or her former job status:
    (1) For an employee removed due to a blood lead level at or above 60 
[micro]g/100 g, or due to an average blood lead level at or above 50 
[micro]g/100 g, when two consecutive blood sampling tests indicate that 
the employee's blood lead level is at or below 40 [micro]g/100 g of 
whole blood;
    (2) For an employee removed due to a final medical determination, 
when a subsequent final medical determination results in a medical 
finding, determination, or opinion that the employee no longer has a 
detected medical condition which places the employee at increased risk 
of material impairment to health from exposure to lead.
    (B) For the purposes of this section, the requirement that an 
employer return an employee to his or her former job status is not 
intended to expand upon or restrict any rights an employee has or would 
have had, absent temporary medical removal, to a specific job 
classification or position under the terms of a collective bargaining 
agreement.
    (iv) Removal of other employee special protective measure or 
limitations. The employer shall remove any limitations placed on an 
employee or end any special protective measures provided to an employee 
pursuant to a final medical determination when a subsequent final 
medical determination indicates that the limitations or special 
protective measures are no longer necessary.
    (v) Employer options pending a final medical determination. Where 
the multiple physician review mechanism, or alternate medical 
determination mechanism used pursuant to the medical surveillance 
provisions of this section, has not yet resulted in a final medical 
determination with respect to an employee, the employer shall act as 
follows:
    (A) Removal. The employer may remove the employee from exposure to 
lead, provide special protective measures to the employee, or place 
limitations upon the employee, consistent with the medical findings, 
determinations, or recommendations of any of the physicians who have 
reviewed the employee's health status.
    (B) Return. The employer may return the employee to his or her 
former job status, end any special protective measures provided to the 
employee, and remove any limitations placed upon the employee, 
consistent with the medical findings, determinations, or recommendations 
of any of the physicians who have reviewed the employee's health status, 
with two exceptions. If
    (1) the initial removal, special protection, or limitation of the 
employee resulted from a final medical determination which differed from 
the findings, determinations, or recommendations of the initial 
physician or
    (2) The employee has been on removal status for the preceding 
eighteen months due to an elevated blood lead level, then the employer 
shall await a final medical determination.
    (2) Medical removal protection benefits--(i) Provision of medical 
removal protection benefits. The employer shall provide to an employee 
up to eighteen (18) months of medical removal protection benefits on 
each occasion that an employee is removed from exposure to lead or 
otherwise limited pursuant to this section.
    (ii) Definition of medical removal protection benefits. For the 
purposes of this section, the requirement that an employer provide 
medical removal protection benefits means that the employer shall 
maintain the earnings, seniority and other employment rights and 
benefits of an employee as though the employee had not been removed from 
normal exposure to lead or otherwise limited.
    (iii) Follow-up medical surveillance during the period of employee 
removal or

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limitation. During the period of time that an employee is removed from 
normal exposure to lead or otherwise limited, the employer may condition 
the provision of medical removal protection benefits upon the employee's 
participation in follow-up medical surveillance made available pursuant 
to this section.
    (iv) Workers' compensation claims. If a removed employee files a 
claim for workers' compensation payments for a lead-related disability, 
then the employer shall continue to provide medical removal protection 
benefits pending disposition of the claim. To the extent that an award 
is made to the employee for earnings lost during the period of removal, 
the employer's medical removal protection obligation shall be reduced by 
such amount. The employer shall receive no credit for workers' 
compensation payments received by the employee for treatment related 
expenses.
    (v) Other credits. The employer's obligation to provide medical 
removal protection benefits to a removed employee shall be reduced to 
the extent that the employee receives compensation for earnings lost 
during the period of removal either from a publicly or employer-funded 
compensation program, or receives income from employment with another 
employer made possible by virtue of the employee's removal.
    (vi) Employees whose blood lead levels do not adequately decline 
within 18 months of removal. The employer shall take the following 
measures with respect to any employee removed from exposure to lead due 
to an elevated blood lead level whose blood lead level has not declined 
within the past eighteen (18) months of removal so that the employee has 
been returned to his or her former job status:
    (A) The employer shall make available to the employee a medical 
examination pursuant to this section to obtain a final medical 
determination with respect to the employee;
    (B) The employer shall assure that the final medical determination 
obtained indicates whether or not the employee may be returned to his or 
her former job status, and if not, what steps should be taken to protect 
the employee's health;
    (C) Where the final medical determination has not yet been obtained, 
or once obtained indicates that the employee may not yet be returned to 
his or her former job status, the employer shall continue to provide 
medical removal protection benefits to the employee until either the 
employee is returned to former job status, or a final medical 
determination is made that the employee is incapable of ever safely 
returning to his or her former job status.
    (D) Where the employer acts pursuant to a final medical 
determination which permits the return of the employee to his or her 
former job status despite what would otherwise be an unacceptable blood 
lead level, later questions concerning removing the employee again shall 
be decided by a final medical determination. The employer need not 
automatically remove such an employee pursuant to the blood lead level 
removal criteria provided by this section.
    (vii) Voluntary Removal or Restriction of An Employee. Where an 
employer, although not required by this section to do so, removes an 
employee from exposure to lead or otherwise places limitations on an 
employee due to the effects of lead exposure on the employee's medical 
condition, the employer shall provide medical removal protection 
benefits to the employee equal to that required by paragraph (k)(2)(i) 
of this section.
    (l) Employee information and training--(1) Training program. (i) 
Each employer who has a workplace in which there is a potential exposure 
to airborne lead at any level shall inform employees of the content of 
Appendices A and B of this regulation.
    (ii) The employer shall train each employee who is subject to 
exposure to lead at or above the action level, or for whom the 
possibility of skin or eye irritation exists, in accordance with the 
requirements of this section. The employer shall institute a training 
program and ensure employee participation in the program.
    (iii) The employer shall provide initial training by 180 days from 
the effective date for those employees covered by paragraph (l)(1) (ii) 
on the standard's effective date and prior to the

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time of initial job assignment for those employees subsequently covered 
by this paragraph.
    (iv) The training program shall be repeated at least annually for 
each employee.
    (v) The employer shall assure that each employee is informed of the 
following:
    (A) The content of this standard and its appendices;
    (B) The specific nature of the operations which could result in 
exposure to lead above the action level;
    (C) The purpose, proper selection, fitting, use, and limitations of 
respirators;
    (D) The purpose and a description of the medical surveillance 
program, and the medical removal protection program including 
information concerning the adverse health effects associated with 
excessive exposure to lead (with particular attention to the adverse 
reproductive effects on both males and females);
    (E) The engineering controls and work practices associated with the 
employee's job assignment;
    (F) The contents of any compliance plan in effect; and
    (G) Instructions to employees that chelating agents should not 
routinely be used to remove lead from their bodies and should not be 
used at all except under the direction of a licensed physician;
    (2) Access to information and training materials. (i) The employer 
shall make readily available to all affected employees a copy of this 
standard and its appendices.
    (ii) The employer shall provide, upon request, all materials 
relating to the employee information and training program to the 
Assistant Secretary and the Director.
    (iii) In addition to the information required by paragraph 
(l)(1)(v), the employer shall include as part of the training program, 
and shall distribute to employees, any materials pertaining to the 
Occupational Safety and Health Act, the regulations issued pursuant to 
that Act, and this lead standard, which are made available to the 
employer by the Assistant Secretary.
    (m) Signs--(1) General. (i) The employer may use signs required by 
other statutes, regulations or ordinances in addition to, or in 
combination with, signs required by this paragraph.
    (ii) The employer shall assure that no statement appears on or near 
any sign required by this paragraph which contradicts or detracts from 
the meaning of the required sign.
    (2) Signs. (i) The employer shall post the following warning signs 
in each work area where the PEL is exceeded:

                                 WARNING

                             LEAD WORK AREA

                                 POISON

                          NO SMOKING OR EATING

    (ii) The employer shall assure that signs required by this paragraph 
are illuminated and cleaned as necessary so that the legend is readily 
visible.
    (n) Recordkeeping--(1) Exposure monitoring. (i) The employer shall 
establish and maintain an accurate record of all monitoring required in 
paragraph (d) of this section.
    (ii) This record shall include:
    (A) The date(s), number, duration, location and results of each of 
the samples taken, including a description of the sampling procedure 
used to determine representative employee exposure where applicable;
    (B) A description of the sampling and analytical methods used and 
evidence of their accuracy;
    (C) The type of respiratory protective devices worn, if any;
    (D) Name, social security number, and job classification of the 
employee monitored and of all other employees whose exposure the 
measurement is intended to represent; and
    (E) The environmental variables that could affect the measurement of 
employee exposure.
    (iii) The employer shall maintain these monitoring records for at 
least 40 years or for the duration of employment plus 20 years, 
whichever is longer.
    (2) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance as required by paragraph (j) of this section.
    (ii) This record shall include:
    (A) The name, social security number, and description of the duties 
of the employee;

[[Page 112]]

    (B) A copy of the physician's written opinions;
    (C) Results of any airborne exposure monitoring done for that 
employee and the representative exposure levels supplied to the 
physician; and
    (D) Any employee medical complaints related to exposure to lead.
    (iii) The employer shall keep, or assure that the examining 
physician keeps, the following medical records:
    (A) A copy of the medical examination results including medical and 
work history required under paragraph (j) of this section;
    (B) A description of the laboratory procedures and a copy of any 
standards or guidelines used to interpret the test results or references 
to that information;
    (C) A copy of the results of biological monitoring.
    (iv) The employer shall maintain or assure that the physician 
maintains those medical records for at least 40 years, or for the 
duration of employment plus 20 years, whichever is longer.
    (3) Medical removals. (i) The employer shall establish and maintain 
an accurate record for each employee removed from current exposure to 
lead pursuant to paragraph (k) of this section.
    (ii) Each record shall include:
    (A) The name and social security number of the employee;
    (B) The date on each occasion that the employee was removed from 
current exposure to lead as well as the corresponding date on which the 
employee was returned to his or her former job status;
    (C) A brief explanation of how each removal was or is being 
accomplished; and
    (D) A statement with respect to each removal indicating whether or 
not the reason for the removal was an elevated blood lead level.
    (iii) The employer shall maintain each medical removal record for at 
least the duration of an employee's employment.
    (4) Availability. (i) The employer shall make available upon request 
all records required to be maintained by paragraph (n) of this section 
to the Assistant Secretary and the Director for examination and copying.
    (ii) Environmental monitoring, medical removal, and medical records 
required by this paragraph shall be provided upon request to employees, 
designated representatives, and the Assistant Secretary in accordance 
with 29 CFR 1910.1020 (a)-(e) and (2)-(i). Medical removal records shall 
be provided in the same manner as environmental monitoring records.
    (5) Transfer of records. (i) Whenever the employer ceases to do 
business, the successor employer shall receive and retain all records 
required to be maintained by paragraph (n) of this section.
    (ii) Whenever the employer ceases to do business and there is no 
successor employer to receive and retain the records required to be 
maintained by this section for the prescribed period, these records 
shall be transmitted to the Director.
    (iii) At the expiration of the retention period for the records 
required to be maintained by this section, the employer shall notify the 
Director at least 3 months prior to the disposal of such records and 
shall transmit those records to the Director if requested within the 
period.
    (iv) The employer shall also comply with any additional requirements 
involving transfer of records set forth in 29 CFR 1910.1020(h).
    (o) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees or their designated 
representatives an opportunity to observe any monitoring of employee 
exposure to lead conducted pursuant to paragraph (d) of this section.
    (2) Observation procedures. (i) Whenever observation of the 
monitoring of employee exposure to lead requires entry into an area 
where the use of respirators, protective clothing or equipment is 
required, the employer shall provide the observer with and assure the 
use of such respirators, clothing and such equipment, and shall require 
the observer to comply with all other applicable safety and health 
procedures.
    (ii) Without interfering with the monitoring, observers shall be 
entitled to:
    (A) Receive an explanation of the measurement procedures;

[[Page 113]]

    (B) Observe all steps related to the monitoring of lead performed at 
the place of exposure; and
    (C) Record the results obtained or receive copies of the results 
when returned by the laboratory.
    (p) Appendices. The information contained in the appendices to this 
section is not intended by itself, to create any additional obligations 
not otherwise imposed by this standard nor detract from any existing 
obligation.

  Appendix A to Sec. 1910.1025--Substance Data Sheet for Occupational 
                            Exposure to Lead

                       i. Substance Identification

    A. Substance: Pure lead (Pb) is a heavy metal at room temperature 
and pressure and is a basic chemical element. It can combine with 
various other substances to form numerous lead compounds.
    B. Compounds Covered by the Standard: The word ``lead'' when used in 
this standard means elemental lead, all inorganic lead compounds and a 
class of organic lead compounds called lead soaps. This standard does 
not apply to other organic lead compounds.
    C. Uses: Exposure to lead occurs in at least 120 different 
occupations, including primary and secondary lead smelting, lead storage 
battery manufacturing, lead pigment manufacturing and use, solder 
manufacturing and use, shipbuilding and ship repairing, auto 
manufacturing, and printing.
    D. Permissible Exposure: The Permissible Exposure Limit (PEL) set by 
the standard is 50 micrograms of lead per cubic meter of air (50 
[micro]g/m\3\), averaged over an 8-hour workday.
    E. Action Level: The standard establishes an action level of 30 
micrograms per cubic meter of air (30 [micro]g/m\3\), time weighted 
average, based on an 8-hour work-day. The action level initiates several 
requirements of the standard, such as exposure monitoring, medical 
surveillance, and training and education.

                         ii. health hazard data

    A. Ways in which lead enters your body. When absorbed into your body 
in certain doses lead is a toxic substance. The object of the lead 
standard is to prevent absorption of harmful quantities of lead. The 
standard is intended to protect you not only from the immediate toxic 
effects of lead, but also from the serious toxic effects that may not 
become apparent until years of exposure have passed.
    Lead can be absorbed into your body by inhalation (breathing) and 
ingestion (eating). Lead (except for certain organic lead compounds not 
covered by the standard, such as tetraethyl lead) is not absorbed 
through your skin. When lead is scattered in the air as a dust, fume or 
mist it can be inhaled and absorbed through you lungs and upper 
respiratory tract. Inhalation of airborne lead is generally the most 
important source of occupational lead absorption. You can also absorb 
lead through your digestive system if lead gets into your mouth and is 
swallowed. If you handle food, cigarettes, chewing tobacco, or make-up 
which have lead on them or handle them with hands contaminated with 
lead, this will contribute to ingestion.
    A significant portion of the lead that you inhale or ingest gets 
into your blood stream. Once in your blood stream, lead is circulated 
throughout your body and stored in various organs and body tissues. Some 
of this lead is quickly filtered out of your body and excreted, but some 
remains in the blood and other tissues. As exposure to lead continues, 
the amount stored in your body will increase if you are absorbing more 
lead than your body is excreting. Even though you may not be aware of 
any immediate symptoms of disease, this lead stored in your tissues can 
be slowly causing irreversible damage, first to individual cells, then 
to your organs and whole body systems.
    B. Effects of overexposure to lead--(1) Short term (acute) 
overexposure. Lead is a potent, systemic poison that serves no known 
useful function once absorbed by your body. Taken in large enough doses, 
lead can kill you in a matter of days. A condition affecting the brain 
called acute encephalopathy may arise which develops quickly to 
seizures, coma, and death from cardiorespiratory arrest. A short term 
dose of lead can lead to acute encephalopathy. Short term occupational 
exposures of this magnitude are highly unusual, but not impossible. 
Similar forms of encephalopathy may, however, arise from extended, 
chronic exposure to lower doses of lead. There is no sharp dividing line 
between rapidly developing acute effects of lead, and chronic effects 
which take longer to acquire. Lead adversely affects numerous body 
systems, and causes forms of health impairment and disease which arise 
after periods of exposure as short as days or as long as several years.
    (2) Long-term (chronic) overexposure. Chronic overexposure to lead 
may result in severe damage to your blood-forming, nervous, urinary and 
reproductive systems. Some common symptoms of chronic overexposure 
include loss of appetite, metallic taste in the mouth, anxiety, 
constipation, nausea, pallor, excessive tiredness, weakness, insomnia, 
headache, nervous irritability, muscle and joint pain or soreness, fine 
tremors, numbness, dizziness, hyperactivity and colic. In lead colic 
there may be severe abdominal pain.
    Damage to the central nervous system in general and the brain 
(encephalopathy) in particular is one of the most severe forms of lead 
poisoning. The most severe, often fatal,

[[Page 114]]

form of encephalopathy may be preceded by vomiting, a feeling of 
dullness progressing to drowsiness and stupor, poor memory, 
restlessness, irritability, tremor, and convulsions. It may arise 
suddenly with the onset of seizures, followed by coma, and death. There 
is a tendency for muscular weakness to develop at the same time. This 
weakness may progress to paralysis often observed as a characteristic 
``wrist drop'' or ``foot drop'' and is a manifestation of a disease to 
the nervous system called peripheral neuropathy.
    Chronic overexposure to lead also results in kidney disease with 
few, if any, symptoms appearing until extensive and most likely 
permanent kidney damage has occurred. Routine laboratory tests reveal 
the presence of this kidney disease only after about two-thirds of 
kidney function is lost. When overt symptoms of urinary dysfunction 
arise, it is often too late to correct or prevent worsening conditions, 
and progression to kidney dialysis or death is possible.
    Chronic overexposure to lead impairs the reproductive systems of 
both men and women. Overexposure to lead may result in decreased sex 
drive, impotence and sterility in men. Lead can alter the structure of 
sperm cells raising the risk of birth defects. There is evidence of 
miscarriage and stillbirth in women whose husbands were exposed to lead 
or who were exposed to lead themselves. Lead exposure also may result in 
decreased fertility, and abnormal menstrual cycles in women. The course 
of pregnancy may be adversely affected by exposure to lead since lead 
crosses the placental barrier and poses risks to developing fetuses. 
Children born of parents either one of whom were exposed to excess lead 
levels are more likely to have birth defects, mental retardation, 
behavioral disorders or die during the first year of childhood.
    Overexposure to lead also disrupts the blood-forming system 
resulting in decreased hemoglobin (the substance in the blood that 
carries oxygen to the cells) and ultimately anemia. Anemia is 
characterized by weakness, pallor and fatigability as a result of 
decreased oxygen carrying capacity in the blood.
    (3) Health protection goals of the standard. Prevention of adverse 
health effects for most workers from exposure to lead throughout a 
working lifetime requires that worker blood lead (PbB) levels be 
maintained at or below forty micrograms per one hundred grams of whole 
blood (40 [micro]g/100g). The blood lead levels of workers (both male 
and female workers) who intend to have children should be maintained 
below 30 [micro]g/100g to minimize adverse reproductive health effects 
to the parents and to the developing fetus.
    The measurement of your blood lead level is the most useful 
indicator of the amount of lead being absorbed by your body. Blood lead 
levels (PbB) are most often reported in units of milligrams (mg) or 
micrograms ([micro]g) of lead (1 mg=1000 [micro]g) per 100 grams (100g), 
100 milliters (100 ml) or deciliter (dl) of blood. These three units are 
essentially the same. Sometime PbB's are expressed in the form of mg% or 
[micro]g%. This is a shorthand notation for 100g, 100 ml, or dl.
    PbB measurements show the amount of lead circulating in your blood 
stream, but do not give any information about the amount of lead stored 
in your various tissues. PbB measurements merely show current absorption 
of lead, not the effect that lead is having on your body or the effects 
that past lead exposure may have already caused. Past research into 
lead-related diseases, however, has focused heavily on associations 
between PbBs and various diseases. As a result, your PbB is an important 
indicator of the likelihood that you will gradually acquire a lead-
related health impairment or disease.
    Once your blood lead level climbs above 40 [micro]g/100g, your risk 
of disease increases. There is a wide variability of individual response 
to lead, thus it is difficult to say that a particular PbB in a given 
person will cause a particular effect. Studies have associated fatal 
encephalopathy with PbBs as low as 150 [micro]g/100g. Other studies have 
shown other forms of diseases in some workers with PbBs well below 80 
[micro]g/100g. Your PbB is a crucial indicator of the risks to your 
health, but one other factor is also extremely important. This factor is 
the length of time you have had elevated PbBs. The longer you have an 
elevated PbB, the greater the risk that large quantities of lead are 
being gradually stored in your organs and tissues (body burden). The 
greater your overall body burden, the greater the chances of substantial 
permanent damage.
    The best way to prevent all forms of lead-related impairments and 
diseases--both short term and long term- is to maintain your PbB below 
40 [micro]g/100g. The provisions of the standard are designed with this 
end in mind. Your employer has prime responsibility to assure that the 
provisions of the standard are complied with both by the company and by 
individual workers. You as a worker, however, also have a responsibility 
to assist your employer in complying with the standard. You can play a 
key role in protecting your own health by learning about the lead 
hazards and their control, learning what the standard requires, 
following the standard where it governs your own actions, and seeing 
that your employer complies with provisions governing his actions.
    (4) Reporting signs and symptoms of health problems. You should 
immediately notify your employer if you develop signs or symptoms 
associated with lead poisoning or if you desire medical advice 
concerning the effects of current or past exposure to lead on your 
ability to have a healthy child. You should

[[Page 115]]

also notify your employer if you have difficulty breathing during a 
respirator fit test or while wearing a respirator. In each of these 
cases your employer must make available to you appropriate medical 
examinations or consultations. These must be provided at no cost to you 
and at a reasonable time and place.
    The standard contains a procedure whereby you can obtain a second 
opinion by a physician of your choice if the employer selected the 
initial physician.

        Appendix B to Sec. 1910.1025--Employee Standard Summary

    This appendix summarizes key provisions of the standard that you as 
a worker should become familiar with.

           i. permissible exposure limit (pel)--paragraph (c)

    The standards sets a permissible exposure limit (PEL) of fifty 
micrograms of lead per cubic meter of air (50 [micro]g/m\3\), averaged 
over an 8-hour work-day. This is the highest level of lead in air to 
which you may be permissibly exposed over an 8-hour workday. Since it is 
an 8-hour average it permits short exposures above the PEL so long as 
for each 8-hour work day your average exposure does not exceed the PEL.
    This standard recognizes that your daily exposure to lead can extend 
beyond a typical 8-hour workday as the result of overtime or other 
alterations in your work schedule. To deal with this, the standard 
contains a formula which reduces your permissible exposure when you are 
exposed more than 8 hours. For example, if you are exposed to lead for 
10 hours a day, the maximum permitted average exposure would be 40 
[micro]g/m\3\.

                 ii. exposure monitoring--paragraph (d)

    If lead is present in the workplace where you work in any quantity, 
your employer is required to make an initial determination of whether 
the action level is exceeded for any employee. This initial 
determination must include instrument monitoring of the air for the 
presence of lead and must cover the exposure of a representative number 
of employees who are reasonably believed to have the highest exposure 
levels. If your employer has conducted appropriate air sampling for lead 
in the past year he may use these results. If there have been any 
employee complaints of symptoms which may be attributable to exposure to 
lead or if there is any other information or observations which would 
indicate employee exposure to lead, this must also be considered as part 
of the initial determination. This initial determination must have been 
completed by March 31, 1979. If this initial determination shows that a 
reasonable possibility exists that any employee may be exposed, without 
regard to respirators, over the action level (30 [micro]g/m\3\) your 
employer must set up an air monitoring program to determine the exposure 
level of every employee exposed to lead at your workplace.
    In carrying out this air monitoring program, your employer is not 
required to monitor the exposure of every employee, but he must monitor 
a representative number of employees and job types. Enough sampling must 
be done to enable each employee's exposure level to be reasonably least 
one full shift (at least 7 hours) air sample. In addition, these air 
samples must be taken under conditions which represent each employee's 
regular, daily exposure to lead. All initial exposure monitoring must 
have been completed by May 30, 1979.
    If you are exposed to lead and air sampling is performed, your 
employer is required to quickly notify you in writing of air monitoring 
results which represent your exposure. If the results indicate your 
exposure exceeds the PEL (without regard to your use of respirators), 
then your employer must also notify you of this in writing, and provide 
you with a description of the corrective action that will be taken to 
reduce your exposure.
    Your exposure must be rechecked by monitoring every six months if 
your exposure is over the action level but below the PEL. Air monitoring 
must be repeated every 3 months if you are exposed over the PEL. Your 
employer may discontinue monitoring for you if 2 consecutive 
measurements, taken at least two weeks apart, are below the action 
level. However, whenever there is a production, process, control, or 
personnel change at your workplace which may result in new or additional 
exposure to lead, or whenever there is any other reason to suspect a 
change which may result in new or additional exposure to lead, your 
employer must perform additional monitoring.

                iii. methods of compliance--paragraph (e)

    Your employer is required to assure that no employee is exposed to 
lead in excess of the PEL. The standard establishes a priority of 
methods to be used to meet the PEL.

                iv. respiratory protection--paragraph (f)

    Your employer is required to provide and assure your use of 
respirators when your exposure to lead is not controlled below the PEL 
by other means. The employer must pay the cost of the respirator. 
Whenever you request one, your employer is also required to provide you 
a respirator even if your air exposure level does not exceed the PEL. 
You might desire a respirator when, for example, you have received 
medical advice that your lead absorption should be decreased. Or, you 
may intend to have children in the near future, and want to reduce the 
level of lead in

[[Page 116]]

your body to minimize adverse reproductive effects. While respirators 
are the least satisfactory means of controlling your exposure, they are 
capable of providing significant protection if properly chosen, fitted, 
worn, cleaned, maintained, and replaced when they stop providing 
adequate protection.
    Your employer is required to select respirators from the seven types 
listed in Table II of the Respiratory Protection section of the standard 
(Sec. 1910.1025(f)). Any respirator chosen must be approved by the 
National Institute for Occupational Safety and Health (NIOSH) under the 
provisions of 42 CFR part 84. This respirator selection table will 
enable your employer to choose a type of respirator that will give you a 
proper amount of protection based on your airborne lead exposure. Your 
employer may select a type of respirator that provides greater 
protection than that required by the standard; that is, one recommended 
for a higher concentration of lead than is present in your workplace. 
For example, a powered air-purifying respirator (PAPR) is much more 
protective than a typical negative pressure respirator, and may also be 
more comfortable to wear. A PAPR has a filter, cartridge, or canister to 
clean the air, and a power source that continuously blows filtered air 
into your breathing zone. Your employer might make a PAPR available to 
you to ease the burden of having to wear a respirator for long periods 
of time. The standard provides that you can obtain a PAPR upon request.
    Your employer must also start a Respiratory Protection Program. This 
program must include written procedures for the proper selection, use, 
cleaning, storage, and maintenance of respirators.
    Your employer must ensure that your respirator facepiece fits 
properly. Proper fit of a respirator facepiece is critical to your 
protection from airborne lead. Obtaining a proper fit on each employee 
may require your employer to make available several different types of 
respirator masks. To ensure that your respirator fits properly and that 
facepiece leakage is minimal, your employer must give you either a 
qualitative or quantitative fit test as specified in Appendix A of the 
Respiratory Protection standard located at 29 CFR 1910.134.
    You must also receive from your employer proper training in the use 
of respirators. Your employer is required to teach you how to wear a 
respirator, to know why it is needed, and to understand its limitations.
    The standard provides that if your respirator uses filter elements, 
you must be given an opportunity to change the filter elements whenever 
an increase in breathing resistance is detected. You also must be 
permitted to periodically leave your work area to wash your face and 
respirator facepiece whenever necessary to prevent skin irritation. If 
you ever have difficulty in breathing during a fit test or while using a 
respirator, your employer must make a medical examination available to 
you to determine whether you can safely wear a respirator. The result of 
this examination may be to give you a positive pressure respirator 
(which reduces breathing resistance) or to provide alternative means of 
protection.

        v. protective work clothing and equipment--paragraph (g)

    If you are exposed to lead above the PEL, or if you are exposed to 
lead compounds such as lead arsenate or lead azide which can cause skin 
and eye irritation, your employer must provide you with protective work 
clothing and equipment appropriate for the hazard. If work clothing is 
provided, it must be provided in a clean and dry condition at least 
weekly, and daily if your airborne exposure to lead is greater than 200 
[micro]g/m\3\. Appropriate protective work clothing and equipment can 
include coveralls or similar full-body work clothing, gloves, hats, 
shoes or disposable shoe coverlets, and face shields or vented goggles. 
Your employer is required to provide all such equipment at no cost to 
you. He is responsible for providing repairs and replacement as 
necessary, and also is responsible for the cleaning, laundering or 
disposal of protective clothing and equipment. Contaminated work 
clothing or equipment must be removed in change rooms and not worn home 
or you will extend your exposure and expose your family since lead from 
your clothing can accumulate in your house, car, etc. Contaminated 
clothing which is to be cleaned, laundered or disposed of must be placed 
in closed containers in the change room. At no time may lead be removed 
from protective clothing or equipment by any means which disperses lead 
into the workroom air.

                     vi. housekeeping--paragraph (h)

    Your employer must establish a housekeeping program sufficient to 
maintain all surfaces as free as practicable of accumulations of lead 
dust. Vacuuming is the preferred method of meeting this requirement, and 
the use of compressed air to clean floors and other surfaces is 
absolutely prohibited. Dry or wet sweeping, shoveling, or brushing may 
not be used except where vaccuming or other equally effective methods 
have been tried and do not work. Vacuums must be used and emptied in a 
manner which minimizes the reentry of lead into the workplace.

          vii. hygiene facilities and practices--paragraph (i)

    The standard requires that change rooms, showers, and filtered air 
lunchrooms be constructed and made available to workers exposed to lead 
above the PEL. When the PEL is exceeded the employer must assure that

[[Page 117]]

food and beverage is not present or consumed, tobacco products are not 
present or used, and cosmetics are not applied, except in these 
facilities. Change rooms, showers, and lunchrooms, must be used by 
workers exposed in excess of the PEL. After showering, no clothing or 
equipment worn during the shift may be worn home, and this includes 
shoes and underwear. Your own clothing worn during the shift should be 
carried home and cleaned carefully so that it does not contaminate your 
home. Lunchrooms may not be entered with protective clothing or 
equipment unless surface dust has been removed by vacuuming, downdraft 
booth, or other cleaning method. Finally, workers exposed above the PEL 
must wash both their hands and faces prior to eating, drinking, smoking 
or applying cosmetics.
    All of the facilities and hygiene practices just discussed are 
essential to minimize additional sources of lead absorption from 
inhalation or ingestion of lead that may accumulate on you, your 
clothes, or your possessions. Strict compliance with these provisions 
can virtually eliminate several sources of lead exposure which 
significantly contribute to excessive lead absorption.

                viii. medical surveillance--paragraph (j)

    The medical surveillance program is part of the standard's 
comprehensive approach to the prevention of lead-related disease. Its 
purpose is to supplement the main thrust of the standard which is aimed 
at minimizing airborne concentrations of lead and sources of ingestion. 
Only medical surveillance can determine if the other provisions of the 
standard have affectively protected you as an individual. Compliance 
with the standard's provision will protect most workers from the adverse 
effects of lead exposure, but may not be satisfactory to protect 
individual workers (1) who have high body burdens of lead acquired over 
past years, (2) who have additional uncontrolled sources of non-
occupational lead exposure, (3) who exhibit unusual variations in lead 
absorption rates, or (4) who have specific non-work related medical 
conditions which could be aggravated by lead exposure (e.g., renal 
disease, anemia). In addition, control systems may fail, or hygiene and 
respirator programs may be inadequate. Periodic medical surveillance of 
individual workers will help detect those failures. Medical surveillance 
will also be important to protect your reproductive ability--regardless 
of whether you are a man or woman.
    All medical surveillance required by the standard must be performed 
by or under the supervision of a licensed physician. The employer must 
provide required medical surveillance without cost to employees and at a 
reasonable time and place. The standard's medical surveillance program 
has two parts-periodic biological monitoring and medical examinations.
    Your employer's obligation to offer you medical surveillance is 
triggered by the results of the air monitoring program. Medical 
surveillance must be made available to all employees who are exposed in 
excess of the action level for more than 30 days a year. The initial 
phase of the medical surveillance program, which includes blood lead 
level tests and medical examinations, must be completed for all covered 
employees no later than August 28, 1979. Priority within this first 
round of medical surveillance must be given to employees whom the 
employer believes to be at greatest risk from continued exposure (for 
example, those with the longest prior exposure to lead, or those with 
the highest current exposure). Thereafter, the employer must 
periodically make medical surveillance--both biological monitoring and 
medical examinations--available to all covered employees.
    Biological monitoring under the standard consists of blood lead 
level (PbB) and zinc protoporphyrin tests at least every 6 months after 
the initial PbB test. A zinc protoporphyrin (ZPP) test is a very useful 
blood test which measures an effect of lead on your body. Thus 
biological monitoring under the standard is currently limited to PbB 
testing. If a worker's PbB exceeds 40 [micro]g/100g the monitoring 
frequency must be increased from every 6 months to at least every 2 
months and not reduced until two consecutive PbBs indicate a blood lead 
level below 40 [micro]g/100g. Each time your PbB is determined to be 
over 40 [micro]g/100g, your employer must notify you of this in writing 
within five working days of his receipt of the test results. The 
employer must also inform you that the standard requires temporary 
medical removal with economic protection when your PbB exceeds certain 
criteria. (See Discussion of Medical Removal Protection--Paragraph (k).) 
During the first year of the standard, this removal criterion is 80 
[micro]g/100g. Anytime your PbB exceeds 80 [micro]g/100g your employer 
must make available to you a prompt follow-up PbB test to ascertain your 
PbB. If the two tests both exceed 80 [micro]g/100g and you are 
temporarily removed, then your employer must make successive PbB tests 
available to you on a monthly basis during the period of your removal.
    Medical examinations beyond the initial one must be made available 
on an annual basis if your blood lead level exceeds 40 [micro]g/100g at 
any time during the preceding year. The initial examination will provide 
information to establish a baseline to which subsequent data can be 
compared. An initial medical examination must also be made available 
(prior to assignment) for each employee being assigned for the first 
time to an area where the airborne concentration of

[[Page 118]]

lead equals or exceeds the action level. In addition, a medical 
examination or consultation must be made available as soon as possible 
if you notify your employer that you are experiencing signs or symptoms 
commonly associated with lead poisoning or that you have difficulty 
breathing while wearing a respirator or during a respirator fit test. 
You must also be provided a medical examination or consultation if you 
notify your employer that you desire medical advice concerning the 
effects of current or past exposure to lead on your ability to procreate 
a healthy child.
    Finally, appropriate follow-up medical examinations or consultations 
may also be provided for employees who have been temporarily removed 
from exposure under the medical removal protection provisions of the 
standard. (See Part IX, below.)
    The standard specifies the minimum content of pre-assignment and 
annual medical examinations. The content of other types of medical 
examinations and consultations is left up to the sound discretion of the 
examining physician. Pre-assignment and annual medical examinations must 
include (1) a detailed work history and medical history, (2) a thorough 
physical examination, and (3) a series of laboratory tests designed to 
check your blood chemistry and your kidney function. In addition, at any 
time upon your request, a laboratory evaluation of male fertility will 
be made (microscopic examination of a sperm sample), or a pregnancy test 
will be given.
    The standard does not require that you participate in any of the 
medical procedures, tests, etc. which your employer is required to make 
available to you. Medical surveillance can, however, play a very 
important role in protecting your health. You are strongly encouraged, 
therefore, to participate in a meaningful fashion. The standard contains 
a multiple physician review mechanism which would give you a chance to 
have a physician of your choice directly participate in the medical 
surveillance program. If you were dissatisfied with an examination by a 
physician chosen by your employer, you could select a second physician 
to conduct an independent analysis. The two doctors would attempt to 
resolve any differences of opinion, and select a third physician to 
resolve any firm dispute. Generally your employer will choose the 
physician who conducts medical surveillance under the lead standard--
unless you and your employer can agree on the choice of a physician or 
physicians. Some companies and unions have agreed in advance, for 
example, to use certain independent medical laboratories or panels of 
physicians. Any of these arrangements are acceptable so long as required 
medical surveillance is made available to workers.
    The standard requires your employer to provide certain information 
to a physician to aid in his or her examination of you. This information 
includes (1) the standard and its appendices, (2) a description of your 
duties as they relate to lead exposure, (3) your exposure level, (4) a 
description of personal protective equipment you wear, (5) prior blood 
lead level results, and (6) prior written medical opinions concerning 
you that the employer has. After a medical examination or consultation 
the physician must prepare a written report which must contain (1) the 
physician's opinion as to whether you have any medical condition which 
places you at increased risk of material impairment to health from 
exposure to lead, (2) any recommended special protective measures to be 
provided to you, (3) any blood lead level determinations, and (4) any 
recommended limitation on your use of respirators. This last element 
must include a determination of whether you can wear a powered air 
purifying respirator (PAPR) if you are found unable to wear a negative 
pressure respirator.
    The medical surveillance program of the lead standard may at some 
point in time serve to notify certain workers that they have acquired a 
disease or other adverse medical condition as a result of occupational 
lead exposure. If this is true, these workers might have legal rights to 
compensation from public agencies, their employers, firms that supply 
hazardous products to their employers, or other persons. Some states 
have laws, including worker compensation laws, that disallow a worker 
who learns of a job-related health impairment to sue, unless the worker 
sues within a short period of time after learning of the impairment. 
(This period of time may be a matter of months or years.) An attorney 
can be consulted about these possibilities. It should be stressed that 
OSHA is in no way trying to either encourage or discourage claims or 
lawsuits. However, since results of the standard's medical surveillance 
program can significantly affect the legal remedies of a worker who has 
acquired a job-related disease or impairment, it is proper for OSHA to 
make you aware of this.
    The medical surveillance section of the standard also contains 
provisions dealing with chelation. Chelation is the use of certain drugs 
(administered in pill form or injected into the body) to reduce the 
amount of lead absorbed in body tissues. Experience accumulated by the 
medical and scientific communities has largely confirmed the 
effectiveness of this type of therapy for the treatment of very severe 
lead poisoning. On the other hand, it has also been established that 
there can be a long list of extremely harmful side effects associated 
with the use of chelating agents. The medical community has balanced the 
advantages and disadvantages resulting from the use of chelating

[[Page 119]]

agents in various circumstances and has established when the use of 
these agents is acceptable. The standard includes these accepted 
limitations due to a history of abuse of chelation therapy by some lead 
companies. The most widely used chelating agents are calcium disodium 
EDTA, (Ca Na2 EDTA), Calcium Disodium Versenate (Versenate), 
and d-penicillamine (pencillamine or Cupramine).
    The standard prohibits ``prophylactic chelation'' of any employee by 
any person the employer retains, supervises or controls. ``Prophylactic 
chelation'' is the routine use of chelating or similarly acting drugs to 
prevent elevated blood levels in workers who are occupationally exposed 
to lead, or the use of these drugs to routinely lower blood lead levels 
to predesignated concentrations believed to be `safe'. It should be 
emphasized that where an employer takes a worker who has no symptoms of 
lead poisoning and has chelation carried out by a physician (either 
inside or outside of a hospital) solely to reduce the worker's blood 
lead level, that will generally be considered prophylactic chelation. 
The use of a hospital and a physician does not mean that prophylactic 
chelation is not being performed. Routine chelation to prevent increased 
or reduce current blood lead levels is unacceptable whatever the 
setting.
    The standard allows the use of ``therapeutic'' or ``diagnostic'' 
chelation if administered under the supervision of a licensed physician 
in a clinical setting with thorough and appropriate medical monitoring. 
Therapeutic chelation responds to severe lead poisoning where there are 
marked symptoms. Diagnostic chelation involved giving a patient a dose 
of the drug then collecting all urine excreted for some period of time 
as an aid to the diagnosis of lead poisoning.
    In cases where the examining physician determines that chelation is 
appropriate, you must be notified in writing of this fact before such 
treatment. This will inform you of a potentially harmful treatment, and 
allow you to obtain a second opinion.

              ix. medical removal protection--paragraph (k)

    Excessive lead absorption subjects you to increased risk of disease. 
Medical removal protection (MRP) is a means of protecting you when, for 
whatever reasons, other methods, such as engineering controls, work 
practices, and respirators, have failed to provide the protection you 
need. MRP involves the temproary removal of a worker from his or her 
regular job to a place of significantly lower exposure without any loss 
of earnings, seniority, or other employment rights or benefits. The 
purpose of this program is to cease further lead absorption and allow 
your body to naturally excrete lead which has previously been absorbed. 
Temporary medical removal can result from an elevated blood lead level, 
or a medical opinion. Up to 18 months of protection is provided as a 
result of either form of removal. The vast majority of removed workers, 
however, will return to their former jobs long before this eighteen 
month period expires. The standard contains special provisions to deal 
with the extraordinary but possible case where a longterm worker's blood 
lead level does not adequately decline during eighteen months of 
removal.
    During the first year of the standard, if your blood lead level is 
80 [micro]g/100g or above you must be removed from any exposure where 
your air lead level without a respirator would be 100 [micro]g/m\3\ or 
above. If you are removed from your normal job you may not be returned 
until your blood lead level declines to at least 60 [micro]g/100g. These 
criteria for removal and return will change according to the following 
schedule:

----------------------------------------------------------------------------------------------------------------
                                          Removal blood lead      Air lead ([micro]g/       Return blood lead
                                           ([micro]g/100 g)              m\3\)               ([micro]g/100 g)
----------------------------------------------------------------------------------------------------------------
After Mar. 1, 1980...................  70 and above...........  50 and above...........  At or below 50.
After Mar. 1, 1981...................  60 and above...........  30 and above...........  At or below 40.
After Mar. 1, 1983...................  50 and above averaged    30 and above...........   Do.
                                        over six months.
----------------------------------------------------------------------------------------------------------------

    You may also be removed from exposure even if your blood lead levels 
are below these criteria if a final medical determination indicates that 
you temporarily need reduced lead exposure for medical reasons. If the 
physician who is implementing your employers medical program makes a 
final written opinion recommending your removal or other special 
protective measures, your employer must implement the physician's 
recommendation. If you are removed in this manner, you may only be 
returned when the doctor indicates that it is safe for you to do so.
    The standard does not give specific instructions dealing with what 
an employer must do with a removed worker. Your job assignment upon 
removal is a matter for you, your employer and your union (if any) to 
work out consistent with existing procedures for job assignments. Each 
removal must be accomplished in a manner consistent with existing 
collective bargaining relationships. Your employer is given broad 
discretion to

[[Page 120]]

implement temporary removals so long as no attempt is made to override 
existing agreements. Similarly, a removed worker is provided no right to 
veto an employer's choice which satisfies the standard.
    In most cases, employers will likely transfer removed employees to 
other jobs with sufficiently low lead exposure. Alternatively, a 
worker's hours may be reduced so that the time weighted average exposure 
is reduced, or he or she may be temporarily laid off if no other 
alternative is feasible.
    In all of these situation, MRP benefits must be provided during the 
period of removal--i.e., you continue to receive the same earnings, 
seniority, and other rights and benefits you would have had if you had 
not been removed. Earnings includes more than just your base wage; it 
includes overtime, shift differentials, incentives, and other 
compensation you would have earned if you had not been removed. During 
the period of removal you must also be provided with appropriate follow-
up medical surveillance. If you were removed because your blood lead 
level was too high, you must be provided with a monthly blood test. If a 
medical opinion caused your removal, you must be provided medical tests 
or examinations that the doctor believes to be appropriate. If you do 
not participate in this follow up medical surveillance, you may lose 
your eligibility for MRP benefits.
    When you are medically eligible to return to your former job, your 
employer must return you to your ``former job status.'' This means that 
you are entitled to the position, wages, benefits, etc., you would have 
had if you had not been removed. If you would still be in your old job 
if no removal had occurred that is where you go back. If not, you are 
returned consistent with whatever job assignment discretion your 
employer would have had if no removal had occurred. MRP only seeks to 
maintain your rights, not expand them or diminish them.
    If you are removed under MRP and you are also eligible for worker 
compensation or other compensation for lost wages, your employer's MRP 
benefits obligation is reduced by the amount that you actually receive 
from these other sources. This is also true if you obtain other 
employment during the time you are laid off with MRP benefits.
    The standard also covers situations where an employer voluntarily 
removes a worker from exposure to lead due to the effects of lead on the 
employee's medical condition, even though the standard does not require 
removal. In these situations MRP benefits must still be provided as 
though the standard required removal. Finally, it is important to note 
that in all cases where removal is required, respirators cannot be used 
as a substitute. Respirators may be used before removal becomes 
necessary, but not as an alternative to a transfer to a low exposure 
job, or to a lay-off with MRP benefits.

           x. employee information and training--paragraph (l)

    Your employer is required to provide an information and training 
program for all employees exposed to lead above the action level or who 
may suffer skin or eye irritation from lead. This program must inform 
these employees of the specific hazards associated with their work 
environment, protective measures which can be taken, the danger of lead 
to their bodies (including their reproductive systems), and their rights 
under the standard. In addition your employer must make readily 
available to all employees, including those exposed below the action 
level, a copy of the standard and its appendices and must distribute to 
all employees any materials provided to the employer by the Occupational 
Safety and Health Administration (OSHA).
    Your employer is required to complete this training program for all 
employees by August 28, 1979. After this date, all new employees must be 
trained prior to initial assignment to areas where there is a 
possibility of exposure over the action level.
    This training program must also be provided at least annually 
thereafter.

                        xi. signs--paragraph (m)

    The standard requires that the following warning sign be posted in 
work areas where the exposure to lead exceeds the PEL:

                                 WARNING

                             LEAD WORK AREA

                          NO SMOKING OR EATING

                    xii. recordkeeping--paragraph (n)

    Your employer is required to keep all records of exposure monitoring 
for airborne lead. These records must include the name and job 
classification of employees measured, details of the sampling and 
analytic techniques, the results of this sampling, and the type of 
respiratory protection being worn by the person sampled. Your employer 
is also required to keep all records of biological monitoring and 
medical examination results. These must include the names of the 
employees, the physician's written opinion, and a copy of the results of 
the examination. All of the above kinds of records must be kept for 40 
years, or for at least 20 years after your termination of employment, 
whichever is longer.
    Recordkeeping is also required if you are temporarily removed from 
your job under the medical removal protection program. This record must 
include your name and social security number, the date of your removal 
and return, how the removal was or is being accomplished, and whether or 
not the

[[Page 121]]

reason for the removal was an elevated blood lead level. Your employer 
is required to keep each medical removal record only for as long as the 
duration of an employee's employment.
    The standard requires that if you request to see or copy 
environmental monitoring, blood lead level monitoring, or medical 
removal records, they must be made available to you or to a 
representative that you authorize. Your union also has access to these 
records. Medical records other than PbB's must also be provided upon 
request to you, to your physician or to any other person whom you may 
specifically designate. Your union does not have access to your personal 
medical records unless you authorize their access.

             xiii. observations of monitoring--paragraph (o)

    When air monitoring for lead is performed at your workplace as 
required by this standard, your employer must allow you or someone you 
designate to act as an observer of the monitoring. Observers are 
entitled to an explanation of the measurement procedure, and to record 
the results obtained. Since results will not normally be available at 
the time of the monitoring, observers are entitled to record or receive 
the results of the monitoring when returned by the laboratory. Your 
employer is required to provide the observer with any personal 
protective devices required to be worn by employees working in the area 
that is being monitored. The employer must require the observer to wear 
all such equipment and to comply with all other applicable safety and 
health procedures.

                     xiv. for additional information

    A. Copies of the Standard and explanatory material may be obtained 
by writing or calling the OSHA Docket Office, U.S. Department of Labor, 
room N2634, 200 Constitution Avenue, N.W., Washington, DC 20210. 
Telephone: (202) 219-7894.
    1. The standard and summary of the statement of reasons (preamble), 
Federal Register, Volume 43, pp. 52952-53014, November 14, 1978.
    2. The full statement of reasons (preamble) Federal Register, vol. 
43, pp. 54354-54509, November 21, 1978.
    3. Partial Administrative Stay and Corrections to the standard, (44 
FR 5446-5448) January 26, 1979.
    4. Notice of the Partial Judicial Stay (44 FR 14554-14555) March 13, 
1979.
    5. Corrections to the preamble, Federal Register, vol. 44, pp. 
20680-20681, April 6, 1979.
    6. Additional correction to the preamble concerning the construction 
industry, Federal Register, vol. 44, p. 50338, August 28, 1979.
    7. Appendices to the standard (Appendices A, B, C), Federal 
Register, Vol. 44, pp. 60980-60995, October 23, 1979.
    8. Corrections to appendices, Federal Register, Vol. 44, 68828, 
November 30, 1979.
    9. Revision to the standard and an additional appendix (Appendix D), 
Federal Register, Vol. 47, pp. 51117-51119, November 12, 1982.
    10. Notice of reopening of lead rulemaking for nine remand industry 
sectors, Federal Register, vol. 53, pp. 11511-11513, April 7, 1988.
    11. Statement of reasons, Federal Register, vol. 54, pp. 29142-
29275, July 11, 1989.
    12. Statement of reasons, Federal Register, vol. 55, pp. 3146-3167, 
January 30, 1990.
    13. Correction to appendix B, Federal Register, vol. 55, pp. 4998-
4999, February 13, 1991.
    14. Correction to appendices, Federal Register, vol. 56, p. 24686, 
May 31, 1991.
    B. Additional information about the standard, its enforcement, and 
your employer's compliance can be obtained from the nearest OSHA Area 
Office listed in your telephone directory under United States 
Government/Department of Labor.

     Appendix C to Sec. 1910.1025--Medical Surveillance Guidelines

                              introduction

    The primary purpose of the Occupational Safety and Health Act of 
1970 is to assure, so far as possible, safe and healthful working 
conditions for every working man and woman. The occupational health 
standard for inorganic lead \1\ was promulgated to protect workers 
exposed to inorganic lead including metallic lead, all inorganic lead 
compounds and organic lead soaps.
---------------------------------------------------------------------------

    \1\ The term inorganic lead used throughout the medical surveillance 
appendices is meant to be synonymous with the definition of lead set 
forth in the standard.
---------------------------------------------------------------------------

    Under this final standard in effect as of March 1, 1979, 
occupational exposure to inorganic lead is to be limited to 50 [micro]g/
m\3\ (micrograms per cubic meter) based on an 8 hour time-weighted 
average (TWA). This level of exposure eventually must be achieved 
through a combination of engineering, work practice and other 
administrative controls. Periods of time ranging from 1 to 10 years are 
provided for different industries to implement these controls. The 
schedule which is based on individual industry considerations is given 
in Table 1. Until these controls are in place, respirators must be used 
to meet the 50 [micro]g/m\3\ exposure limit.
    The standard also provides for a program of biological monitoring 
and medical surveillance for all employees exposed to levels of 
inorganic lead above the action level of 30 [micro]g/m\3\ (TWA) for more 
than 30 days per year.

[[Page 122]]

    The purpose of this document is to outline the medical surveillance 
provisions of the standard for inorganic lead, and to provide further 
information to the physician regarding the examination and evaluation of 
workers exposed to inorganic lead.
    Section 1 provides a detailed description of the monitoring 
procedure including the required frequency of blood testing for exposed 
workers, provisions for medical removal protection (MRP), the 
recommended right of the employee to a second medical opinion, and 
notification and recordkeeping requirements of the employer. A 
discussion of the requirements for respirator use and respirator 
monitoring and OSHA's position on prophylactic chelation therapy are 
also included in this section.
    Section 2 discusses the toxic effects and clinical manifestations of 
lead poisoning and effects of lead intoxication on enzymatic pathways in 
heme synthesis. The adverse effects on both male and female reproductive 
capacity and on the fetus are also discussed.
    Section 3 outlines the recommended medical evaluation of the worker 
exposed to inorganic lead including details of the medical history, 
physical examination, and recommended laboratory tests, which are based 
on the toxic effects of lead as discussed in Section 2.
    Section 4 provides detailed information concerning the laboratory 
tests available for the monitoring of exposed workers. Included also is 
a discussion of the relative value of each test and the limitations and 
precautions which are necessary in the interpretation of the laboratory 
results.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
                                                                            Effective date
                                                     -----------------------------------------------------------
    Permissible airborne lead levels by industry                                                         Mar. 1,
                 ([micro]g/m\3\) \1\                   Mar. 1,   Mar. 1,   Mar. 1,   Mar. 1,   Mar. 1,    1989
                                                        1979      1980      1981      1982      1984     (final)
----------------------------------------------------------------------------------------------------------------
1. Primary lead production..........................       200       200       200       100       100        50
2. Secondary lead production........................       200       200       200       100        50        50
3. Lead-acid battery manufacturing..................       200       200       100       100        50        50
4. Nonferrous foundries.............................       200       100       100       100        50        50
5. Lead pigment manufacturing.......................       200       200       200       100        50        50
6. All other industries.............................       200        50        50        50        50        50
----------------------------------------------------------------------------------------------------------------
\1\ Airborne levels to be achieved without reliance or respirator protection through a combination of
  engineering, work practice and other administrative controls. While these controls are being implemented
  respirators must be used to meet the 50 [micro]g/m\3\ exposure limit.

i. medical surveillance and monitoring requirements for workers exposed 
                            to inorganic lead

    Under the occupational health standard for inorganic lead, a program 
of biological monitoring and medical surveillance is to be made 
available to all employees exposed to lead above the action level of 30 
[micro]g/m\3\ TWA for more than 30 days each year. This program consists 
of periodic blood sampling and medical evaluation to be performed on a 
schedule which is defined by previous laboratory results, worker 
complaints or concerns, and the clinical assessment of the examining 
physician.
    Under this program, the blood lead level of all employees who are 
exposed to lead above the action level of 30 [micro]g/m\3\ is to be 
determined at least every six months. The frequency is increased to 
every two months for employees whose last blood lead level was between 
40 [micro]g/100 g whole blood and the level requiring employee medical 
removal to be discussed below. For employees who are removed from 
exposure to lead due to an elevated blood lead, a new blood lead level 
must be measured monthly. A zinc protoporphyrin (ZPP) is required on 
each occasion that a blood lead level measurement is made.
    An annual medical examination and consultation performed under the 
guidelines discussed in Section 3 is to be made available to each 
employee for whom a blood test conducted at any time during the 
preceding 12 months indicated a blood lead level at or above 40 
[micro]g/100 g. Also, an examination is to be given to all employees 
prior to their assignment to an area in which airborne lead 
concentrations reach or exceed the action level. In addition, a medical 
examination must be provided as soon as possible after notification by 
an employee that the employee has developed signs or symptoms commonly 
associated with lead intoxication, that the employee desires medical 
advice regarding lead exposure and the ability to procreate a healthy 
child, or that the employee has demonstrated difficulty in breathing 
during a respirator fitting test or during respirator use. An 
examination is also to be made available to each employee removed from 
exposure to lead due to a risk of sustaining material impairment to 
health, or otherwise limited or specially protected pursuant to medical 
recommendations.

[[Page 123]]

    Results of biological monitoring or the recommendations of an 
examining physician may necessitate removal of an employee from further 
lead exposure pursuant to the standard's medical removal protection 
(MRP) program. The object of the MRP program is to provide temporary 
medical removal to workers either with substantially elevated blood lead 
levels or otherwise at risk of sustaining material health impairment 
from continued substantial exposure to lead. The following guidelines 
which are summarized in Table 2 were created under the standard for the 
temporary removal of an exposed employee and his or her subsequent 
return to work in an exposure area.

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
                                                                  Effective date
                                --------------------------------------------------------------------------------
                                                                                                  Mar. 1, 1983
                                  Mar. 1, 1979    Mar. 1, 1980    Mar. 1, 1981   Mar. 1, 1982       (final)
----------------------------------------------------------------------------------------------------------------
A. Blood lead level requiring    =80  =70  =6  =6  =60[mi
 employee medical removal.        [micro]g/100    [micro]g/100    0 [micro]g/    0 [micro]g/    cro]g/100 g or
 (Level must be confirmed with    g               g               100 g          100 g          average of last
 second follow-up blood lead                                                                    three blood
 level within two weeks of                                                                      samples or all
 first report.).                                                                                blood samples
                                                                                                over previous 6
                                                                                                months
                                                                                                (whichever is
                                                                                                over a longer
                                                                                                time period) is
                                                                                                50 [micro]g/100
                                                                                                g or greater
                                                                                                unless last
                                                                                                blood sample is
                                                                                                40 [micro]g/100
                                                                                                g or less.
B. Frequency which employees
 exposed to action level of
 lead (30 [micro]g/m\3\ TWA)
 must have blood lead level
 checked (ZPP is also required
 in each occasion that a blood
 lead is obtained.):
  1. Last blood lead level less  Every 6 months  Every 6 months  Every 6        Every 6        Every 6 months.
   than 40 [micro]g/100 g.                                        months         months
  2. Last blood lead level       Every 2 months  Every 2 months  Every 2        Every 2        Every 2 months.
   between 40 [micro]g/100 g                                      months         months
   and level requiring medical
   removal (see A above).
  3. Employees removed from      Every 1 month   Every 1 month   Every 1 month  Every 1 month  Every 1 month.
   exposure to lead because of
   an elevated blood lead level.
C. Permissible airborne          100 [micro]g/   50 [micro]g/    30 [micro]g/   30 [micro]g/   30 [micro]g/m\3\
 exposure limit for workers       m\3\ 8 hr TWA   m\3\ 8 hr TWA   m\3\ 8 hr      m\3\ 8 hr      8 hr TWA.
 removed from work due to an                                      TWA            TWA
 elevated blood lead level
 (without regard to respirator
 protection).
D. Blood lead level confirmed    [middot]60      [middot]50      [middot]40     [middot]40     [middot]40
 with a second blood analysis,    [micro]g/100    [micro]g/100    [micro]g/100   [micro]g/100   [micro]g/100 g.
 at which employee may return     g               g               g              g
 to work. Permissible exposure
 without regard to respirator
 protection is listed by
 industry in Table I.
----------------------------------------------------------------------------------------------------------------
Note: When medical opinion indicates that an employee is at risk of material impairment from exposure to lead,
  the physician can remove an employee from exposures exceeding the action level (or less) or recommend special
  protective measures as deemed appropriate and necessary. Medical monitoring during the medical removal period
  can be more stringent than noted in the table above if the physician so specifies. Return to work or removal
  of limitations and special protections is permitted when the physician indicates that the worker is no longer
  at risk of material impairment.

    Under the standard's ultimate worker removal criteria, a worker is 
to be removed from any work having any eight hour TWA exposure to lead 
of 30 [micro]g/m\3\ or more whenever either of the following 
circumstances apply: (1) a blood lead level of 60 [micro]g/100 g or 
greater is obtained and confirmed by a second follow-up blood lead level 
performed within two weeks after the employer receives the results of 
the first blood sampling test, or (2) the average of the previous three 
blood lead determinations or the average of all blood lead 
determinations conducted during the previous six months, whichever 
encompasses the longest time period, equals or exceeds 50 [micro]g/100 
g, unless the last blood sample indicates a blood lead level at or below 
40 [micro]g/100 g in which case the employee need not be removed. 
Medical removal is to continue until two consecutive blood lead levels 
are 40 [micro]g/100 g or less.
    During the first two years that the ultimate removal criteria are 
being phased in, the return criteria have been set to assure that a 
worker's blood lead level has substantially declined during the period 
of removal. From March 1, 1979 to March 1, 1980, the blood lead level 
requiring employee medical

[[Page 124]]

removal is 80 [micro]g/100 g. Workers found to have a confirmed blood 
lead at this level or greater need only be removed from work having a 
daily 8 hour TWA exposure to lead at or above 100 [micro]g/m\3\. Workers 
so removed are to be returned to work when their blood lead levels are 
at or below 60 [micro]g/100 g of whole blood. From March 1, 1980 to 
March 1, 1981, the blood lead level requiring medical removal is 70 
[micro]g/100 g. During this period workers need only be removed from 
jobs having a daily 8 hour TWA exposure to lead at or above 50 [micro]g/
m\3\ and are to be returned to work when a level of 50 [micro]g/100 g is 
achieved. Beginning March 1, 1981, return depends on a worker's blood 
lead level declining to 40 [micro]g/100 g of whole blood.
    As part of the standard, the employer is required to notify in 
writing each employee whose blood lead level exceeds 40 [micro]g/100 g. 
In addition each such employee is to be informed that the standard 
requires medical removal with MRP benefits, discussed below, when an 
employee's blood lead level exceeds the above defined limits.
    In addition to the above blood lead level criteria, temporary worker 
removal may also take place as a result of medical determinations and 
recommendations. Written medical opinions must be prepared after each 
examination pursuant to the standard. If the examining physician 
includes a medical finding, determination or opinion that the employee 
has a medical condition which places the employee at increased risk of 
material health impairment from exposure to lead, then the employee must 
be removed from exposure to lead at or above the action level. 
Alternatively, if the examining physician recommends special protective 
measures for an employee (e.g., use of a powered air purifying 
respirator) or recommends limitations on an employee's exposure to lead, 
then the employer must implement these recommendations. Recommendations 
may be more stringent than the specific provisions of the standard. The 
examining physician, therefore, is given broad flexibility to tailor 
special protective procedures to the needs of individual employees. This 
flexibility extends to the evaluation and management of pregnant workers 
and male and female workers who are planning to raise children. Based on 
the history, physical examination, and laboratory studies, the physician 
might recommend special protective measures or medical removal for an 
employee who is pregnant or who is planning to conceive a child when, in 
the physician's judgment, continued exposure to lead at the current job 
would pose a significant risk. The return of the employee to his or her 
former job status, or the removal of special protections or limitations, 
depends upon the examining physician determining that the employee is no 
longer at increased risk of material impairment or that special measures 
are no longer needed.
    During the period of any form of special protection or removal, the 
employer must maintain the worker's earnings, seniority, and other 
employment rights and benefits (as though the worker had not been 
removed) for a period of up to 18 months. This economic protection will 
maximize meaningful worker participation in the medical surveillance 
program, and is appropriate as part of the employer's overall obligation 
to provide a safe and healthful workplace. The provisions of MRP 
benefits during the employee's removal period may, however, be 
conditioned upon participation in medical surveillance.
    On rare occasions, an employee's blood lead level may not acceptably 
decline within 18 months of removal. This situation will arise only in 
unusual circumstances, thus the standard relies on an individual medical 
examination to determine how to protect such an employee. This medical 
determination is to be based on both laboratory values, including lead 
levels, zinc protoporphyrin levels, blood counts, and other tests felt 
to be warranted, as well as the physician's judgment that any symptoms 
or findings on physical examination are a result of lead toxicity. The 
medical determination may be that the employee is incapable of ever 
safely returning to his or her former job status. The medical 
determination may provide additional removal time past 18 months for 
some employees or specify special protective measures to be implemented.
    The lead standard provides for a multiple physician review in cases 
where the employee wishes a second opinion concerning potential lead 
poisoning or toxicity. If an employee wishes a second opinion, he or she 
can make an appointment with a physician of his or her choice. This 
second physician will review the findings, recommendations or 
determinations of the first physician and conduct any examinations, 
consultations or tests deemed necessary in an attempt to make a final 
medical determination. If the first and second physicians do not agree 
in their assessment they must try to resolve their differences. If they 
cannot reach an agreement then they must designate a third physician to 
resolve the dispute.
    The employer must provide examining and consulting physicians with 
the following specific information: a copy of the lead regulations and 
all appendices, a description of the employee's duties as related to 
exposure, the exposure level to lead and any other toxic substances (if 
applicable), a description of personal protective equipment used, blood 
lead levels, and all prior written medical opinions regarding the 
employee in the employer's possession or control. The employer must also 
obtain from the physician and provide the employee with a written 
medical opinion containing blood lead levels, the physicians's opinion 
as to whether the employee is at risk of material impairment to

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health, any recommended protective measures for the employee if further 
exposure is permitted, as well as any recommended limitations upon an 
employee's use of respirators.
    Employers must instruct each physician not to reveal to the employer 
in writing or in any other way his or her findings, laboratory results, 
or diagnoses which are felt to be unrelated to occupational lead 
exposure. They must also instruct each physician to advise the employee 
of any occupationally or non-occupationally related medical condition 
requiring further treatment or evaluation.
    The standard provides for the use of respirators where engineering 
and other primary controls have not been fully implemented. However, the 
use of respirator protection shall not be used in lieu of temporary 
medical removal due to elevated blood lead levels or findings that an 
employee is at risk of material health impairment. This is based on the 
numerous inadequacies of respirators including skin rash where the 
facepiece makes contact with the skin, unacceptable stress to breathing 
in some workers with underlying cardiopulmonary impairment, difficulty 
in providing adequate fit, the tendency for respirators to create 
additional hazards by interfering with vision, hearing, and mobility, 
and the difficulties of assuring the maximum effectiveness of a 
complicated work practice program involving respirators. Respirators do, 
however, serve a useful function where engineering and work practice 
controls are inadequate by providing supplementary, interim, or short-
term protection, provided they are properly selected for the environment 
in which the employee will be working, properly fitted to the employee, 
maintained and cleaned periodically, and worn by the employee when 
required.
    In its final standard on occupational exposure to inorganic lead, 
OSHA has prohibited prophylactic chelation. Diagnostic and therapeutic 
chelation are permitted only under the supervision of a licensed 
physician with appropriate medical monitoring in an acceptable clinical 
setting. The decision to initiate chelation therapy must be made on an 
individual basis and take into account the severity of symptoms felt to 
be a result of lead toxicity along with blood lead levels, ZPP levels, 
and other laboratory tests as appropriate. EDTA and penicillamine which 
are the primary chelating agents used in the therapy of occupational 
lead poisoning have significant potential side effects and their use 
must be justified on the basis of expected benefits to the worker. 
Unless frank and severe symptoms are present, therapeutic chelation is 
not recommended given the opportunity to remove a worker from exposure 
and allow the body to naturally excrete accumulated lead. As a 
diagnostic aid, the chelation mobilization test using CA-EDTA has 
limited applicability. According to some investigators, the test can 
differentiate between lead-induced and other nephropathies. The test may 
also provide an estimation of the mobile fraction of the total body lead 
burden.
    Employers are required to assure that accurate records are 
maintained on exposure monitoring, medical surveillance, and medical 
removal for each employee. Exposure monitoring and medical surveillance 
records must be kept for 40 years or the duration of employment plus 20 
years, whichever is longer, while medical removal records must be 
maintained for the duration of employment. All records required under 
the standard must be made available upon request to the Assistant 
Secretary of Labor for Occupational Safety and Health and the Director 
of the National Institute for Occupational Safety and Health. Employers 
must also make environmental and biological monitoring and medical 
removal records available to affected employees and to former employees 
or their authorized employee representatives. Employees or their 
specifically designated representatives have access to their entire 
medical surveillance records.
    In addition, the standard requires that the employer inform all 
workers exposed to lead at or above the action level of the provisions 
of the standard and all its appendices, the purpose and description of 
medical surveillance and provisions for medical removal protection if 
temporary removal is required. An understanding of the potential health 
effects of lead exposure by all exposed employees along with full 
understanding of their rights under the lead standard is essential for 
an effective monitoring program.

              ii. adverse health effects of inorganic lead

    Although the toxicity of lead has been known for 2,000 years, the 
knowledge of the complex relationship between lead exposure and human 
response is still being refined. Significant research into the toxic 
properties of lead continues throughout the world, and it should be 
anticipated that our understanding of thresholds of effects and margins 
of safety will be improved in future years. The provisions of the lead 
standard are founded on two prime medical judgments: first, the 
prevention of adverse health effects from exposure to lead throughout a 
working lifetime requires that worker blood lead levels be maintained at 
or below 40 [micro]g/100 g and second, the blood lead levels of workers, 
male or female, who intend to parent in the near future should be 
maintained below 30 [micro]g/100 g to minimize adverse reproductive 
health effects to the parents and developing fetus. The adverse effects 
of lead on reproduction are being actively researched

[[Page 126]]

and OSHA encourages the physician to remain abreast of recent 
developments in the area to best advise pregnant workers or workers 
planning to conceive children.
    The spectrum of health effects caused by lead exposure can be 
subdivided into five developmental stages: normal, physiological changes 
of uncertain significance, pathophysiological changes, overt symptoms 
(morbidity), and mortality. Within this process there are no sharp 
distinctions, but rather a continuum of effects. Boundaries between 
categories overlap due to the wide variation of individual responses and 
exposures in the working population. OSHA's development of the lead 
standard focused on pathophysiological changes as well as later stages 
of disease.
    1. Heme Synthesis Inhibition. The earliest demonstrated effect of 
lead involves its ability to inhibit at least two enzymes of the heme 
synthesis pathway at very low blood levels. Inhibition of delta 
aminolevulinic acid dehydrase (ALA-D) which catalyzes the conversion of 
delta-aminolevulinic acid (ALA) to protoporphyrin is observed at a blood 
lead level below 20 [micro]g/100 g whole blood. At a blood lead level of 
40 ug/100 g, more than 20% of the population would have 70% inhibition 
of ALA-D. There is an exponential increase in ALA excretion at blood 
lead levels greater than 40 [micro]g/100 g.
    Another enzyme, ferrochelatase, is also inhibited at low blood lead 
levels. Inhibition of ferrochelatase leads to increased free erythrocyte 
protoporphyrin (FEP) in the blood which can then bind to zinc to yield 
zinc protoporphyrin. At a blood lead level of 50 [micro]g/100 g or 
greater, nearly 100% of the population will have an increase in FEP. 
There is also an exponential relationship between blood lead levels 
greater than 40 [micro]g/100 g and the associated ZPP level, which has 
led to the development of the ZPP screening test for lead exposure.
    While the significance of these effects is subject to debate, it is 
OSHA's position that these enzyme disturbances are early stages of a 
disease process which may eventually result in the clinical symptoms of 
lead poisoning. Whether or not the effects do progress to the later 
stages of clinical disease, disruption of these enzyme processes over a 
working lifetime is considered to be a material impairment of health.
    One of the eventual results of lead-induced inhibition of enzymes in 
the heme synthesis pathway is anemia which can be asymptomatic if mild 
but associated with a wide array of symptoms including dizziness, 
fatigue, and tachycardia when more severe. Studies have indicated that 
lead levels as low as 50 [micro]g/100 g can be associated with a 
definite decreased hemoglobin, although most cases of lead-induced 
anemia, as well as shortened red-cell survival times, occur at lead 
levels exceeding 80 [micro]g/100 g. Inhibited hemoglobin synthesis is 
more common in chronic cases whereas shortened erythrocyte life span is 
more common in acute cases.
    In lead-induced anemias, there is usually a reticulocytosis along 
with the presence of basophilic stippling, and ringed sideroblasts, 
although none of the above are pathognomonic for lead-induced anemia.
    2. Neurological Effects. Inorganic lead has been found to have toxic 
effects on both the central and peripheral nervous systems. The earliest 
stages of lead-induced central nervous system effects first manifest 
themselves in the form of behavioral disturbances and central nervous 
system symptoms including irritability, restlessness, insomnia and other 
sleep disturbances, fatigue, vertigo, headache, poor memory, tremor, 
depression, and apathy. With more severe exposure, symptoms can progress 
to drowsiness, stupor, hallucinations, delerium, convulsions and coma.
    The most severe and acute form of lead poisoning which usually 
follows ingestion or inhalation of large amounts of lead is acute 
encephalopathy which may arise precipitously with the onset of 
intractable seizures, coma, cardiorespiratory arrest, and death within 
48 hours.
    While there is disagreement about what exposure levels are needed to 
produce the earliest symptoms, most experts agree that symptoms 
definitely can occur at blood lead levels of 60 [micro]g/100 g whole 
blood and therefore recommend a 40 [micro]g/100 g maximum. The central 
nervous system effects frequently are not reversible following 
discontinued exposure or chelation therapy and when improvement does 
occur, it is almost always only partial.
    The peripheral neuropathy resulting from lead exposure 
characteristically involves only motor function with minimal sensory 
damage and has a marked predilection for the extensor muscles of the 
most active extremity. The peripheral neuropathy can occur with varying 
degrees of severity. The earliest and mildest form which can be detected 
in workers with blood lead levels as low as 50 [micro]g/100 g is 
manifested by slowing of motor nerve conduction velocity often without 
clinical symptoms. With progression of the neuropathy there is 
development of painless extensor muscle weakness usually involving the 
extensor muscles of the fingers and hand in the most active upper 
extremity, followed in severe cases by wrist drop or, much less 
commonly, foot drop.
    In addition to slowing of nerve conduction, electromyographical 
studies in patients with blood lead levels greater than 50 [micro]g/100 
g have demonstrated a decrease in the number of acting motor unit 
potentials, an increase in the duration of motor unit potentials, and 
spontaneous pathological activity including fibrillations and 
fasciculations. Whether these effects occur at levels of 40 [micro]g/100 
g is undetermined.

[[Page 127]]

    While the peripheral neuropathies can occasionally be reversed with 
therapy, again such recovery is not assured particularly in the more 
severe neuropathies and often improvement is only partial. The lack of 
reversibility is felt to be due in part to segmental demyelination.
    3. Gastrointestinal. Lead may also affect the gastrointestinal 
system producing abdominal colic or diffuse abdominal pain, 
constipation, obstipation, diarrhea, anorexia, nausea and vomiting. Lead 
colic rarely develops at blood lead levels below 80 [micro]g/100 g.
    4. Renal. Renal toxicity represents one of the most serious health 
effects of lead poisoning. In the early stages of disease nuclear 
inclusion bodies can frequently be identified in proximal renal tubular 
cells. Renal function remains normal and the changes in this stage are 
probably reversible. With more advanced disease there is progressive 
interstitial fibrosis and impaired renal function. Eventually extensive 
interstitial fibrosis ensues with sclerotic glomeruli and dilated and 
atrophied proximal tubules; all represent end stage kidney disease. 
Azotemia can be progressive, eventually resulting in frank uremia 
necessitating dialysis. There is occasionally associated hypertension 
and hyperuricemia with or without gout.
    Early kidney disease is difficult to detect. The urinalysis is 
normal in early lead nephropathy and the blood urea nitrogen and serum 
creatinine increase only when two-thirds of kidney function is lost. 
Measurement of creatinine clearance can often detect earlier disease as 
can other methods of measurement of glomerular filtration rate. An 
abnormal Ca-EDTA mobilization test has been used to differentiate 
between lead-induced and other nephropathies, but this procedure is not 
widely accepted. A form of Fanconi syndrome with aminoaciduria, 
glycosuria, and hyperphosphaturia indicating severe injury to the 
proximal renal tubules is occasionally seen in children.
    5. Reproductive effects. Exposure to lead can have serious effects 
on reproductive function in both males and females. In male workers 
exposed to lead there can be a decrease in sexual drive, impotence, 
decreased ability to produce healthy sperm, and sterility. Malformed 
sperm (teratospermia), decreased number of sperm (hypospermia), and 
sperm with decreased motility (asthenospermia) can all occur. 
Teratospermia has been noted at mean blood lead levels of 53 [micro]g/
100 g and hypospermia and asthenospermia at 41 [micro]g/100 g. 
Furthermore, there appears to be a dose-response relationship for 
teratospermia in lead exposed workers.
    Women exposed to lead may experience menstrual disturbances 
including dysmenorrhea, menorrhagia and amenorrhea. Following exposure 
to lead, women have a higher frequency of sterility, premature births, 
spontaneous miscarriages, and stillbirths.
    Germ cells can be affected by lead and cause genetic damage in the 
egg or sperm cells before conception and result in failure to implant, 
miscarriage, stillbirth, or birth defects.
    Infants of mothers with lead poisoning have a higher mortality 
during the first year and suffer from lowered birth weights, slower 
growth, and nervous system disorders.
    Lead can pass through the placental barrier and lead levels in the 
mother's blood are comparable to concentrations of lead in the umbilical 
cord at birth. Transplacental passage becomes detectable at 12-14 weeks 
of gestation and increases until birth.
    There is little direct data on damage to the fetus from exposure to 
lead but it is generally assumed that the fetus and newborn would be at 
least as susceptible to neurological damage as young children. Blood 
lead levels of 50-60 [micro]g/100 g in children can cause significant 
neurobehavioral impairments and there is evidence of hyperactivity at 
blood levels as low as 25 [micro]g/100 g. Given the overall body of 
literature concerning the adverse health effects of lead in children, 
OSHA feels that the blood lead level in children should be maintained 
below 30 [micro]g/100 g with a population mean of 15 [micro]g/100 g. 
Blood lead levels in the fetus and newborn likewise should not exceed 30 
[micro]g/100 g.
    Because of lead's ability to pass through the placental barrier and 
also because of the demonstrated adverse effects of lead on reproductive 
function in both the male and female as well as the risk of genetic 
damage of lead on both the ovum and sperm, OSHA recommends a 30 
[micro]g/100 g maximum permissible blood lead level in both males and 
females who wish to bear children.
    6. Other toxic effects. Debate and research continue on the effects 
of lead on the human body. Hypertension has frequently been noted in 
occupationally exposed individuals although it is difficult to assess 
whether this is due to lead's adverse effects on the kidney or if some 
other mechanism is involved. Vascular and electrocardiogarphic changes 
have been detected but have not been well characterized. Lead is thought 
to impair thyroid function and interfere with the pituitary-adrenal 
axis, but again these effects have not been well defined.

                         iii. medical evaluation

    The most important principle in evaluating a worker for any 
occupational disease including lead poisoning is a high index of 
suspicion on the part of the examining physician. As discussed in 
Section 2, lead can affect numerous organ systems and produce a wide 
array of signs and symptoms, most of which are non-specific and subtle 
in nature at least in the early stages of disease. Unless serious 
concern for lead toxicity is present,

[[Page 128]]

many of the early clues to diagnosis may easily be overlooked.
    The crucial initial step in the medical evaluation is recognizing 
that a worker's employment can result in exposure to lead. The worker 
will frequently be able to define exposures to lead and lead containing 
materials but often will not volunteer this information unless 
specifically asked. In other situations the worker may not know of any 
exposures to lead but the suspicion might be raised on the part of the 
physician because of the industry or occupation of the worker. Potential 
occupational exposure to lead and its compounds occur in at least 120 
occupations, including lead smelting, the manufacture of lead storage 
batteries, the manufacture of lead pigments and products containing 
pigments, solder manufacture, shipbuilding and ship repair, auto 
manufacturing, construction, and painting.
    Once the possibility for lead exposure is raised, the focus can then 
be directed toward eliciting information from the medical history, 
physical exam, and finally from laboratory data to evaluate the worker 
for potential lead toxicity.
    A complete and detailed work history is important in the initial 
evaluation. A listing of all previous employment with information on 
work processes, exposure to fumes or dust, known exposures to lead or 
other toxic substances, respiratory protection used, and previous 
medical surveillance should all be included in the worker's record. 
Where exposure to lead is suspected, information concerning on-the-job 
personal hygiene, smoking or eating habits in work areas, laundry 
procedures, and use of any protective clothing or respiratory protection 
equipment should be noted. A complete work history is essential in the 
medical evaluation of a worker with suspected lead toxicity, especially 
when long term effects such as neurotoxicity and nephrotoxicity are 
considered.
    The medical history is also of fundamental importance and should 
include a listing of all past and current medical conditions, current 
medications including proprietary drug intake, previous surgeries and 
hospitalizations, allergies, smoking history, alcohol consumption, and 
also non-occupational lead exposures such as hobbies (hunting, riflery). 
Also known childhood exposures should be elicited. Any previous history 
of hematological, neurological, gastrointestinal, renal, psychological, 
gynecological, genetic, or reproductive problems should be specifically 
noted.
    A careful and complete review must be performed to assess both 
recognized complaints and subtle or slowly acquired symptoms which the 
worker might not appreciate as being significant. The review of symptoms 
should include the following:
    General--weight loss, fatigue, decreased appetite.
    Head, Eyes, Ears, Nose, Throat (HEENT)--headaches, visual 
disturbances or decreased visual acuity, hearing deficits or tinnitus, 
pigmentation of the oral mucosa, or metallic taste in mouth.
    Cardio-pulmonary--shortness of breath, cough, chest pains, 
palpitations, or orthopnea.
    Gastrointestinal--nausea, vomiting, heartburn, abdominal pain, 
constipation or diarrhea.
    Neurologic--irritability, insomnia, weakness (fatigue), dizziness, 
loss of memory, confusion, hallucinations, incoordination, ataxia, 
decreased strength in hands or feet, disturbances in gait, difficulty in 
climbing stairs, or seizures.
    Hematologic--pallor, easy fatigability, abnormal blood loss, melena.
    Reproductive (male and female and spouse where relevant)--history of 
infertility, impotence, loss of libido, abnormal menstrual periods, 
history of miscarriages, stillbirths, or children with birth defects.
    Musculo-skeletal--muscle and joint pains.
    The physical examination should emphasize the neurological, 
gastrointestinal, and cardiovascular systems. The worker's weight and 
blood pressure should be recorded and the oral mucosa checked for 
pigmentation characteristic of a possible Burtonian or lead line on the 
gingiva. It should be noted, however, that the lead line may not be 
present even in severe lead poisoning if good oral hygiene is practiced.
    The presence of pallor on skin examination may indicate an anemia, 
which if severe might also be associated with a tachycardia. If an 
anemia is suspected, an active search for blood loss should be 
undertaken including potential blood loss through the gastrointestinal 
tract.
    A complete neurological examination should include an adequate 
mental status evaluation including a search for behavioral and 
psychological disturbances, memory testing, evaluation for irritability, 
insomnia, hallucinations, and mental clouding. Gait and coordination 
should be examined along with close observation for tremor. A detailed 
evaluation of peripheral nerve function including careful sensory and 
motor function testing is warranted. Strength testing particularly of 
extensor muscle groups of all extremities is of fundamental importance.
    Cranial nerve evaluation should also be included in the routine 
examination.
    The abdominal examination should include auscultation for bowel 
sounds and abdominal bruits and palpation for organomegaly, masses, and 
diffuse abdominal tenderness.
    Cardiovascular examination should evaluate possible early signs of 
congestive heart

[[Page 129]]

failure. Pulmonary status should be addressed particularly if respirator 
protection is contemplated.
    As part of the medical evaluation, the lead standard requires the 
following laboratory studies:
    1. Blood lead level
    2. Hemoglobin and hematocrit determinations, red cell indices, and 
examination of the peripheral blood smear to evaluate red blood cell 
morphology
    3. Blood urea nitrogen
    4. Serum creatinine
    5. Routine urinalysis with microscopic examination.
    6. A zinc protoporphyrin level
    In addition to the above, the physician is authorized to order any 
further laboratory or other tests which he or she deems necessary in 
accordance with sound medical practice. The evaluation must also include 
pregnancy testing or laboratory evaluation of male fertility if 
requested by the employee.
    Additional tests which are probably not warranted on a routine basis 
but may be appropriate when blood lead and ZPP levels are equivocal 
include delta aminolevulinic acid and coproporphyrin concentrations in 
the urine, and dark-field illumination for detection of basophilic 
stippling in red blood cells.
    If an anemia is detected further studies including a careful 
examination of the peripheral smear, reticulocyte count, stool for 
occult blood, serum iron, total iron binding capacity, bilirubin, and, 
if appropriate, vitamin B12 and folate may be of value in attempting to 
identify the cause of the anemia.
    If a peripheral neuropathy is suspected, nerve conduction studies 
are warranted both for diagnosis and as a basis to monitor any therapy.
    If renal disease is questioned, a 24 hour urine collection for 
creatinine clearance, protein, and electrolytes may be indicated. 
Elevated uric acid levels may result from lead-induced renal disease and 
a serum uric acid level might be performed.
    An electrocardiogram and chest x-ray may be obtained as deemed 
appropriate.
    Sophisticated and highly specialized testing should not be done 
routinely and where indicated should be under the direction of a 
specialist.

                        iv. laboratory evaluation

    The blood lead level at present remains the single most important 
test to monitor lead exposure and is the test used in the medical 
surveillance program under the lead standard to guide employee medical 
removal. The ZPP has several advantages over the blood lead level. 
Because of its relatively recent development and the lack of extensive 
data concerning its interpretation, the ZPP currently remains an 
ancillary test.
    This section will discuss the blood lead level and ZPP in detail and 
will outline their relative advantages and disadvantages. Other blood 
tests currently available to evaluate lead exposure will also be 
reviewed.
    The blood lead level is a good index of current or recent lead 
absorption when there is no anemia present and when the worker has not 
taken any chelating agents. However, blood lead levels along with 
urinary lead levels do not necessarily indicate the total body burden of 
lead and are not adequate measures of past exposure. One reason for this 
is that lead has a high affinity for bone and up to 90% of the body's 
total lead is deposited there. A very important component of the total 
lead body burden is lead in soft tissue (liver, kidney, and brain). This 
fraction of the lead body burden, the biologically active lead, is not 
entirely reflected by blood lead levels since it is a function of the 
dynamics of lead absorption, distribution, deposition in bone and 
excretion. Following discontinuation of exposure to lead, the excess 
body burden is only slowly mobilized from bone and other relatively 
stable body stores and excreted. Consequently, a high blood lead level 
may only represent recent heavy exposure to lead without a significant 
total body excess and likewise a low blood lead level does not exclude 
an elevated total body burden of lead.
    Also due to its correlation with recent exposures, the blood lead 
level may vary considerably over short time intervals.
    To minimize laboratory error and erroneous results due to 
contamination, blood specimens must be carefully collected after 
thorough cleaning of the skin with appropriate methods using lead-free 
blood containers and analyzed by a reliable laboratory. Under the 
standard, samples must be analyzed in laboratories which are approved by 
the Center for Disease Control (CDC) or which have received satisfactory 
grades in proficiency testing by the CDC in the previous year. Analysis 
is to be made using atomic absorption spectrophotometry, anodic 
stripping voltammetry or any method which meets the accuracy 
requirements set forth by the standard.
    The determination of lead in urine is generally considered a less 
reliable monitoring technique than analysis of whole blood primarily due 
to individual variability in urinary excretion capacity as well as the 
technical difficulty of obtaining accurate 24 hour urine collections. In 
addition, workers with renal insufficiency, whether due to lead or some 
other cause, may have decreased lead clearance and consequently urine 
lead levels may underestimate the true lead burden. Therefore, urine 
lead levels should not be used as a routine test.
    The zinc protoporphyrin test, unlike the blood lead determination, 
measures an adverse metabolic effect of lead and as such is

[[Page 130]]

a better indicator of lead toxicity than the level of blood lead itself. 
The level of ZPP reflects lead absorption over the preceding 3 to 4 
months, and therefore is a better indicator of lead body burden. The ZPP 
requires more time than the blood lead to read significantly elevated 
levels; the return to normal after discontinuing lead exposure is also 
slower. Furthermore, the ZPP test is simpler, faster, and less expensive 
to perform and no contamination is possible. Many investigators believe 
it is the most reliable means of monitoring chronic lead absorption.
    Zinc protoporphyrin results from the inhibition of the enzyme 
ferrochelatase which catalyzes the insertion of an iron molecule into 
the protoporphyrin molecule, which then becomes heme. If iron is not 
inserted into the molecule then zinc, having a greater affinity for 
protoporphyrin, takes the place of the iron, forming ZPP.
    An elevation in the level of circulating ZPP may occur at blood lead 
levels as low as 20-30 [micro]g/100 g in some workers. Once the blood 
lead level has reached 40 [micro]g/100 g there is more marked rise in 
the ZPP value from its normal range of less than 100 [micro]g/100 ml. 
Increases in blood lead levels beyond 40 [micro]g/100 g are associated 
with exponential increases in ZPP.
    Whereas blood lead levels fluctuate over short time spans, ZPP 
levels remain relatively stable. ZPP is measured directly in red blood 
cells and is present for the cell's entire 120 day life-span. Therefore, 
the ZPP level in blood reflects the average ZPP production over the 
previous 3-4 months and consequently the average lead exposure during 
that time interval.
    It is recommended that a hematocrit be determined whenever a 
confirmed ZPP of 50 [micro]g/100 ml whole blood is obtained to rule out 
a significant underlying anemia. If the ZPP is in excess of 100 
[micro]g/100 ml and not associated with abnormal elevations in blood 
lead levels, the laboratory should be checked to be sure that blood 
leads were determined using atomic absorption spectrophotometry anodic 
stripping voltammetry, or any method which meets the accuracy 
requirements set forth by the standard by a CDC approved laboratory 
which is experienced in lead level determinations. Repeat periodic blood 
lead studies should be obtained in all individuals with elevated ZPP 
levels to be certain that an associated elevated blood lead level has 
not been missed due to transient fluctuations in blood leads.
    ZPP has a characteristic fluorescence spectrum with a peak at 594 nm 
which is detectable with a hematofluorimeter. The hematofluorimeter is 
accurate and portable and can provide on-site, instantaneous results for 
workers who can be frequently tested via a finger prick.
    However, careful attention must be given to calibration and quality 
control procedures. Limited data on blood lead--ZPP correlations and the 
ZPP levels which are associated with the adverse health effects 
discussed in Section 2 are the major limitations of the test. Also it is 
difficult to correlate ZPP levels with environmental exposure and there 
is some variation of response with age and sex. Nevertheless, the ZPP 
promises to be an important diagnostic test for the early detection of 
lead toxicity and its value will increase as more data is collected 
regarding its relationship to other manifestations of lead poisoning.
    Levels of delta-aminolevulinic acid (ALA) in the urine are also used 
as a measure of lead exposure. Increasing concentrations of ALA are 
believed to result from the inhibition of the enzyme delta-
aminolevulinic acid dehydrase (ALA-D). Although the test is relatively 
easy to perform, inexpensive, and rapid, the disadvantages include 
variability in results, the necessity to collect a complete 24 hour 
urine sample which has a specific gravity greater than 1.010, and also 
the fact that ALA decomposes in the presence of light.
    The pattern of porphyrin excretion in the urine can also be helpful 
in identifying lead intoxication. With lead poisoning, the urine 
concentrations of coproporphyrins I and II, porphobilinogen and 
uroporphyrin I rise. The most important increase, however, is that of 
coproporphyrin III; levels may exceed 5,000 [micro]g/1 in the urine in 
lead poisoned individuals, but its correlation with blood lead levels 
and ZPP are not as good as those of ALA. Increases in urinary porphyrins 
are not diagnostic of lead toxicity and may be seen in porphyria, some 
liver diseases, and in patients with high reticulocyte counts.
    Summary. The Occupational Safety and Health Administration's 
standard for inorganic lead places significant emphasis on the medical 
surveillance of all workers exposed to levels of inorganic lead above 
the action level of 30 [micro]g/m\3\ TWA. The physician has a 
fundamental role in this surveillance program, and in the operation of 
the medical removal protection program.
    Even with adequate worker education on the adverse health effects of 
lead and appropriate training in work practices, personal hygiene and 
other control measures, the physician has a primary responsibility for 
evaluating potential lead toxicity in the worker. It is only through a 
careful and detailed medical and work history, a complete physical 
examination and appropriate laboratory testing that an accurate 
assessment can be made. Many of the adverse health effects of lead 
toxicity are either irreversible or only partially reversible and 
therefore early detection of disease is very important.

[[Page 131]]

    This document outlines the medical monitoring program as defined by 
the occupational safety and health standard for inorganic lead. It 
reviews the adverse health effects of lead poisoning and describes the 
important elements of the history and physical examinations as they 
relate to these adverse effects. Finally, the appropriate laboratory 
testing for evaluating lead exposure and toxicity is presented.
    It is hoped that this review and discussion will give the physician 
a better understanding of the OSHA standard with the ultimate goal of 
protecting the health and well-being of the worker exposed to lead under 
his or her care.

[43 FR 53007, Nov. 14, 1978]

    Editorial Note: For Federal Register citations affecting Sec. 
1910.1025 see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 1910.1026  Chromium (VI).

    (a) Scope. (1) This standard applies to occupational exposures to 
chromium (VI) in all forms and compounds in general industry, except:
    (2) Exposures that occur in the application of pesticides regulated 
by the Environmental Protection Agency or another Federal government 
agency (e.g., the treatment of wood with preservatives);
    (3) Exposures to portland cement; or
    (4) Where the employer has objective data demonstrating that a 
material containing chromium or a specific process, operation, or 
activity involving chromium cannot release dusts, fumes, or mists of 
chromium (VI) in concentrations at or above 0.5 [micro]gm/m\3\ as an 8-
hour time-weighted average (TWA) under any expected conditions of use.
    (b) Definitions. For the purposes of this section the following 
definitions apply:
    Action level means a concentration of airborne chromium (VI) of 2.5 
micrograms per cubic meter of air (2.5 [micro]gm/m\3\) calculated as an 
8-hour time-weighted average (TWA).
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Chromium (VI) [hexavalent chromium or Cr(VI)] means chromium with a 
valence of positive six, in any form and in any compound.
    Director means the Director of the National Institute for 
Occupational Safety and Health (NIOSH), U.S. Department of Health and 
Human Services, or designee.
    Emergency means any occurrence that results, or is likely to result, 
in an uncontrolled release of chromium (VI). If an incidental release of 
chromium (VI) can be controlled at the time of release by employees in 
the immediate release area, or by maintenance personnel, it is not an 
emergency.
    Employee exposure means the exposure to airborne chromium (VI) that 
would occur if the employee were not using a respirator.
    High-efficiency particulate air [HEPA] filter means a filter that is 
at least 99.97 percent efficient in removing mono-dispersed particles of 
0.3 micrometers in diameter or larger.
    Historical monitoring data means data from chromium (VI) monitoring 
conducted prior to May 30, 2006, obtained during work operations 
conducted under workplace conditions closely resembling the processes, 
types of material, control methods, work practices, and environmental 
conditions in the employer's current operations.
    Objective data means information such as air monitoring data from 
industry-wide surveys or calculations based on the composition or 
chemical and physical properties of a substance demonstrating the 
employee exposure to chromium (VI) associated with a particular product 
or material or a specific process, operation, or activity. The data must 
reflect workplace conditions closely resembling the processes, types of 
material, control methods, work practices, and environmental conditions 
in the employer's current operations.
    Physician or other licensed health care professional [PLHCP] is an 
individual whose legally permitted scope of practice (i.e., license, 
registration, or certification) allows him or her to independently 
provide or be delegated the responsibility to provide some or all of the 
particular health care services required by paragraph (k) of this 
section.
    Regulated area means an area, demarcated by the employer, where an 
employee's exposure to airborne concentrations of chromium (VI) exceeds,

[[Page 132]]

or can reasonably be expected to exceed, the PEL.
    This section means this Sec. 1910.1026 chromium (VI) standard.
    (c) Permissible exposure limit (PEL). The employer shall ensure that 
no employee is exposed to an airborne concentration of chromium (VI) in 
excess of 5 micrograms per cubic meter of air (5 [micro]gm/m\3\), 
calculated as an 8-hour time-weighted average (TWA).
    (d) Exposure determination--(1) General. Each employer who has a 
workplace or work operation covered by this section shall determine the 
8-hour TWA exposure for each employee exposed to chromium (VI). This 
determination shall be made in accordance with either paragraph (d)(2) 
or paragraph (d)(3) of this section.
    (2) Scheduled monitoring option. (i) The employer shall perform 
initial monitoring to determine the 8-hour TWA exposure for each 
employee on the basis of a sufficient number of personal breathing zone 
air samples to accurately characterize full shift exposure on each 
shift, for each job classification, in each work area. Where an employer 
does representative sampling instead of sampling all employees in order 
to meet this requirement, the employer shall sample the employee(s) 
expected to have the highest chromium (VI) exposures.
    (ii) If initial monitoring indicates that employee exposures are 
below the action level, the employer may discontinue monitoring for 
those employees whose exposures are represented by such monitoring.
    (iii) If monitoring reveals employee exposures to be at or above the 
action level, the employer shall perform periodic monitoring at least 
every six months.
    (iv) If monitoring reveals employee exposures to be above the PEL, 
the employer shall perform periodic monitoring at least every three 
months.
    (v) If periodic monitoring indicates that employee exposures are 
below the action level, and the result is confirmed by the result of 
another monitoring taken at least seven days later, the employer may 
discontinue the monitoring for those employees whose exposures are 
represented by such monitoring.
    (vi) The employer shall perform additional monitoring when there has 
been any change in the production process, raw materials, equipment, 
personnel, work practices, or control methods that may result in new or 
additional exposures to chromium (VI), or when the employer has any 
reason to believe that new or additional exposures have occurred.
    (3) Performance-oriented option. The employer shall determine the 8-
hour TWA exposure for each employee on the basis of any combination of 
air monitoring data, historical monitoring data, or objective data 
sufficient to accurately characterize employee exposure to chromium 
(VI).
    (4) Employee notification of determination results. (i) Where the 
exposure determination indicates that employee exposure exceeds the PEL, 
within 15 working days the employer shall either post the results in an 
appropriate location that is accessible to all affected employees or 
shall notify each affected employee individually in writing of the 
results.
    (ii) Whenever the exposure determination indicates that employee 
exposure is above the PEL, the employer shall describe in the written 
notification the corrective action being taken to reduce employee 
exposure to or below the PEL.
    (5) Accuracy of measurement. Where air monitoring is performed to 
comply with the requirements of this section, the employer shall use a 
method of monitoring and analysis that can measure chromium (VI) to 
within an accuracy of plus or minus 25 percent ( 
25%) and can produce accurate measurements to within a statistical 
confidence level of 95 percent for airborne concentrations at or above 
the action level.
    (6) Observation of monitoring. (i) Where air monitoring is performed 
to comply with the requirements of this section, the employer shall 
provide affected employees or their designated representatives an 
opportunity to observe any monitoring of employee exposure to chromium 
(VI).
    (ii) When observation of monitoring requires entry into an area 
where the use of protective clothing or equipment is required, the 
employer shall provide

[[Page 133]]

the observer with clothing and equipment and shall assure that the 
observer uses such clothing and equipment and complies with all other 
applicable safety and health procedures.
    (e) Regulated areas--(1) Establishment. The employer shall establish 
a regulated area wherever an employee's exposure to airborne 
concentrations of chromium (VI) is, or can reasonably be expected to be, 
in excess of the PEL.
    (2) Demarcation. The employer shall ensure that regulated areas are 
demarcated from the rest of the workplace in a manner that adequately 
establishes and alerts employees of the boundaries of the regulated 
area.
    (3) Access. The employer shall limit access to regulated areas to:
    (i) Persons authorized by the employer and required by work duties 
to be present in the regulated area;
    (ii) Any person entering such an area as a designated representative 
of employees for the purpose of exercising the right to observe 
monitoring procedures under paragraph (d) of this section; or
    (iii) Any person authorized by the Occupational Safety and Health 
Act or regulations issued under it to be in a regulated area.
    (f) Methods of compliance--(1) Engineering and work practice 
controls. (i) Except as permitted in paragraph (f)(1)(ii) and paragraph 
(f)(1)(iii) of this section, the employer shall use engineering and work 
practice controls to reduce and maintain employee exposure to chromium 
(VI) to or below the PEL unless the employer can demonstrate that such 
controls are not feasible. Wherever feasible engineering and work 
practice controls are not sufficient to reduce employee exposure to or 
below the PEL, the employer shall use them to reduce employee exposure 
to the lowest levels achievable, and shall supplement them by the use of 
respiratory protection that complies with the requirements of paragraph 
(g) of this section.
    (ii) Where painting of aircraft or large aircraft parts is performed 
in the aerospace industry, the employer shall use engineering and work 
practice controls to reduce and maintain employee exposure to chromium 
(VI) to or below 25 [micro]gm/m\3\ unless the employer can demonstrate 
that such controls are not feasible. The employer shall supplement such 
engineering and work practice controls with the use of respiratory 
protection that complies with the requirements of paragraph (g) of this 
section to achieve the PEL.
    (iii) Where the employer can demonstrate that a process or task does 
not result in any employee exposure to chromium (VI) above the PEL for 
30 or more days per year (12 consecutive months), the requirement to 
implement engineering and work practice controls to achieve the PEL does 
not apply to that process or task.
    (2) Prohibition of rotation. The employer shall not rotate employees 
to different jobs to achieve compliance with the PEL.
    (g) Respiratory protection--(1) General. Where respiratory 
protection is required by this section, the employer must provide each 
employee an appropriate respirator that complies with the requirements 
of this paragraph. Respiratory protection is required during:
    (i) Periods necessary to install or implement feasible engineering 
and work practice controls;
    (ii) Work operations, such as maintenance and repair activities, for 
which engineering and work practice controls are not feasible;
    (iii) Work operations for which an employer has implemented all 
feasible engineering and work practice controls and such controls are 
not sufficient to reduce exposures to or below the PEL;
    (iv) Work operations where employees are exposed above the PEL for 
fewer than 30 days per year, and the employer has elected not to 
implement engineering and work practice controls to achieve the PEL; or
    (v) Emergencies.
    (2) Respiratory protection program. Where respirator use is required 
by this section, the employer shall institute a respiratory protection 
program in accordance with Sec. 1910.134, which covers each employee 
required to use a respirator.
    (h) Protective work clothing and equipment--(1) Provision and use. 
Where a hazard is present or is likely to be present from skin or eye 
contact with

[[Page 134]]

chromium (VI), the employer shall provide appropriate personal 
protective clothing and equipment at no cost to employees, and shall 
ensure that employees use such clothing and equipment.
    (2) Removal and storage. (i) The employer shall ensure that 
employees remove all protective clothing and equipment contaminated with 
chromium (VI) at the end of the work shift or at the completion of their 
tasks involving chromium (VI) exposure, whichever comes first.
    (ii) The employer shall ensure that no employee removes chromium 
(VI)-contaminated protective clothing or equipment from the workplace, 
except for those employees whose job it is to launder, clean, maintain, 
or dispose of such clothing or equipment.
    (iii) When contaminated protective clothing or equipment is removed 
for laundering, cleaning, maintenance, or disposal, the employer shall 
ensure that it is stored and transported in sealed, impermeable bags or 
other closed, impermeable containers.
    (iv) Bags or containers of contaminated protective clothing or 
equipment that are removed from change rooms for laundering, cleaning, 
maintenance, or disposal shall be labeled in accordance with the 
requirements of the Hazard Communication Standard, 29 CFR 1910.1200.
    (3) Cleaning and replacement. (i) The employer shall clean, launder, 
repair and replace all protective clothing and equipment required by 
this section as needed to maintain its effectiveness.
    (ii) The employer shall prohibit the removal of chromium (VI) from 
protective clothing and equipment by blowing, shaking, or any other 
means that disperses chromium (VI) into the air or onto an employee's 
body.
    (iii) The employer shall inform any person who launders or cleans 
protective clothing or equipment contaminated with chromium (VI) of the 
potentially harmful effects of exposure to chromium (VI) and that the 
clothing and equipment should be laundered or cleaned in a manner that 
minimizes skin or eye contact with chromium (VI) and effectively 
prevents the release of airborne chromium (VI) in excess of the PEL.
    (i) Hygiene areas and practices--(1) General. Where protective 
clothing and equipment is required, the employer shall provide change 
rooms in conformance with 29 CFR 1910.141. Where skin contact with 
chromium (VI) occurs, the employer shall provide washing facilities in 
conformance with 29 CFR 1910.141. Eating and drinking areas provided by 
the employer shall also be in conformance with Sec. 1910.141.
    (2) Change rooms. The employer shall assure that change rooms are 
equipped with separate storage facilities for protective clothing and 
equipment and for street clothes, and that these facilities prevent 
cross-contamination.
    (3) Washing facilities. (i) The employer shall provide readily 
accessible washing facilities capable of removing chromium (VI) from the 
skin, and shall ensure that affected employees use these facilities when 
necessary.
    (ii) The employer shall ensure that employees who have skin contact 
with chromium (VI) wash their hands and faces at the end of the work 
shift and prior to eating, drinking, smoking, chewing tobacco or gum, 
applying cosmetics, or using the toilet.
    (4) Eating and drinking areas. (i) Whenever the employer allows 
employees to consume food or beverages at a worksite where chromium (VI) 
is present, the employer shall ensure that eating and drinking areas and 
surfaces are maintained as free as practicable of chromium (VI).
    (ii) The employer shall ensure that employees do not enter eating 
and drinking areas with protective work clothing or equipment unless 
surface chromium (VI) has been removed from the clothing and equipment 
by methods that do not disperse chromium (VI) into the air or onto an 
employee's body.
    (5) Prohibited activities. The employer shall ensure that employees 
do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in 
regulated areas, or in areas where skin or eye contact with chromium 
(VI) occurs; or carry the products associated with these activities, or 
store such products in these areas.
    (j) Housekeeping--(1) General. The employer shall ensure that:

[[Page 135]]

    (i) All surfaces are maintained as free as practicable of 
accumulations of chromium (VI).
    (ii) All spills and releases of chromium (VI) containing material 
are cleaned up promptly.
    (2) Cleaning methods. (i) The employer shall ensure that surfaces 
contaminated with chromium (VI) are cleaned by HEPA-filter vacuuming or 
other methods that minimize the likelihood of exposure to chromium (VI).
    (ii) Dry shoveling, dry sweeping, and dry brushing may be used only 
where HEPA-filtered vacuuming or other methods that minimize the 
likelihood of exposure to chromium (VI) have been tried and found not to 
be effective.
    (iii) The employer shall not allow compressed air to be used to 
remove chromium (VI) from any surface unless:
    (A) The compressed air is used in conjunction with a ventilation 
system designed to capture the dust cloud created by the compressed air; 
or
    (B) No alternative method is feasible.
    (iv) The employer shall ensure that cleaning equipment is handled in 
a manner that minimizes the reentry of chromium (VI) into the workplace.
    (3) Disposal. The employer shall ensure that:
    (i) Waste, scrap, debris, and any other materials contaminated with 
chromium (VI) and consigned for disposal are collected and disposed of 
in sealed, impermeable bags or other closed, impermeable containers.
    (ii) Bags or containers of waste, scrap, debris, and any other 
materials contaminated with chromium (VI) that are consigned for 
disposal are labeled in accordance with the requirements of the Hazard 
Communication Standard, 29 CFR 1910.1200.
    (k) Medical surveillance--(1) General. (i) The employer shall make 
medical surveillance available at no cost to the employee, and at a 
reasonable time and place, for all employees:
    (A) Who are or may be occupationally exposed to chromium (VI) at or 
above the action level for 30 or more days a year;
    (B) Experiencing signs or symptoms of the adverse health effects 
associated with chromium (VI) exposure; or
    (C) Exposed in an emergency.
    (ii) The employer shall assure that all medical examinations and 
procedures required by this section are performed by or under the 
supervision of a PLHCP.
    (2) Frequency. The employer shall provide a medical examination:
    (i) Within 30 days after initial assignment, unless the employee has 
received a chromium (VI) related medical examination that meets the 
requirements of this paragraph within the last twelve months;
    (ii) Annually;
    (iii) Within 30 days after a PLHCP's written medical opinion 
recommends an additional examination;
    (iv) Whenever an employee shows signs or symptoms of the adverse 
health effects associated with chromium (VI) exposure;
    (v) Within 30 days after exposure during an emergency which results 
in an uncontrolled release of chromium (VI); or
    (vi) At the termination of employment, unless the last examination 
that satisfied the requirements of paragraph (k) of this section was 
less than six months prior to the date of termination.
    (3) Contents of examination. A medical examination consists of:
    (i) A medical and work history, with emphasis on: Past, present, and 
anticipated future exposure to chromium (VI); any history of respiratory 
system dysfunction; any history of asthma, dermatitis, skin ulceration, 
or nasal septum perforation; and smoking status and history;
    (ii) A physical examination of the skin and respiratory tract; and
    (iii) Any additional tests deemed appropriate by the examining 
PLHCP.
    (4) Information provided to the PLHCP. The employer shall ensure 
that the examining PLHCP has a copy of this standard, and shall provide 
the following information:
    (i) A description of the affected employee's former, current, and 
anticipated duties as they relate to the employee's occupational 
exposure to chromium (VI);
    (ii) The employee's former, current, and anticipated levels of 
occupational exposure to chromium (VI);

[[Page 136]]

    (iii) A description of any personal protective equipment used or to 
be used by the employee, including when and for how long the employee 
has used that equipment; and
    (iv) Information from records of employment-related medical 
examinations previously provided to the affected employee, currently 
within the control of the employer.
    (5) PLHCP's written medical opinion. (i) The employer shall obtain a 
written medical opinion from the PLHCP, within 30 days for each medical 
examination performed on each employee, which contains:
    (A) The PLHCP's opinion as to whether the employee has any detected 
medical condition(s) that would place the employee at increased risk of 
material impairment to health from further exposure to chromium (VI);
    (B) Any recommended limitations upon the employee's exposure to 
chromium (VI) or upon the use of personal protective equipment such as 
respirators;
    (C) A statement that the PLHCP has explained to the employee the 
results of the medical examination, including any medical conditions 
related to chromium (VI) exposure that require further evaluation or 
treatment, and any special provisions for use of protective clothing or 
equipment.
    (ii) The PLHCP shall not reveal to the employer specific findings or 
diagnoses unrelated to occupational exposure to chromium (VI).
    (iii) The employer shall provide a copy of the PLHCP's written 
medical opinion to the examined employee within two weeks after 
receiving it.
    (l) Communication of chromium (VI) hazards to employees.
    (1) General. In addition to the requirements of the Hazard 
Communication Standard, 29 CFR 1910.1200, employers shall comply with 
the following requirements.
    (2) Employee information and training. (i) The employer shall ensure 
that each employee can demonstrate knowledge of at least the following:
    (A) The contents of this section; and
    (B) The purpose and a description of the medical surveillance 
program required by paragraph (k) of this section.
    (ii) The employer shall make a copy of this section readily 
available without cost to all affected employees.
    (m) Recordkeeping--(1) Air monitoring data. (i) The employer shall 
maintain an accurate record of all air monitoring conducted to comply 
with the requirements of this section.
    (ii) This record shall include at least the following information:
    (A) The date of measurement for each sample taken;
    (B) The operation involving exposure to chromium (VI) that is being 
monitored;
    (C) Sampling and analytical methods used and evidence of their 
accuracy;
    (D) Number, duration, and the results of samples taken;
    (E) Type of personal protective equipment, such as respirators worn; 
and
    (F) Name, social security number, and job classification of all 
employees represented by the monitoring, indicating which employees were 
actually monitored.
    (iii) The employer shall ensure that exposure records are maintained 
and made available in accordance with 29 CFR 1910.1020.
    (2) Historical monitoring data. (i) Where the employer has relied on 
historical monitoring data to determine exposure to chromium (VI), the 
employer shall establish and maintain an accurate record of the 
historical monitoring data relied upon.
    (ii) The record shall include information that reflects the 
following conditions:
    (A) The data were collected using methods that meet the accuracy 
requirements of paragraph (d)(5) of this section;
    (B) The processes and work practices that were in use when the 
historical monitoring data were obtained are essentially the same as 
those to be used during the job for which exposure is being determined;
    (C) The characteristics of the chromium (VI) containing material 
being handled when the historical monitoring data were obtained are the 
same as those on the job for which exposure is being determined;
    (D) Environmental conditions prevailing when the historical 
monitoring

[[Page 137]]

data were obtained are the same as those on the job for which exposure 
is being determined; and
    (E) Other data relevant to the operations, materials, processing, or 
employee exposures covered by the exception.
    (iii) The employer shall ensure that historical exposure records are 
maintained and made available in accordance with 29 CFR 1910.1020.
    (3) Objective data. (i) The employer shall maintain an accurate 
record of all objective data relied upon to comply with the requirements 
of this section.
    (ii) This record shall include at least the following information:
    (A) The chromium containing material in question;
    (B) The source of the objective data;
    (C) The testing protocol and results of testing, or analysis of the 
material for the release of chromium (VI);
    (D) A description of the process, operation, or activity and how the 
data support the determination; and
    (E) Other data relevant to the process, operation, activity, 
material, or employee exposures.
    (iii) The employer shall ensure that objective data are maintained 
and made available in accordance with 29 CFR 1910.1020.
    (4) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee covered by medical 
surveillance under paragraph (k) of this section.
    (ii) The record shall include the following information about the 
employee:
    (A) Name and social security number;
    (B) A copy of the PLHCP's written opinions;
    (C) A copy of the information provided to the PLHCP as required by 
paragraph (k)(4) of this section.
    (iii) The employer shall ensure that medical records are maintained 
and made available in accordance with 29 CFR 1910.1020.
    (n) Dates. (1) For employers with 20 or more employees, all 
obligations of this section, except engineering controls required by 
paragraph (f) of this section, commence November 27, 2006.
    (2) For employers with 19 or fewer employees, all obligations of 
this section, except engineering controls required by paragraph (f) of 
this section, commence May 30, 2007.
    (3) Except as provided in (n)(4), for all employers, engineering 
controls required by paragraph (f) of this section shall be implemented 
no later than May 31, 2010.
    (4) In facilities that become parties to the settlement agreement 
included in Appendix A, engineering controls required by paragraph (f) 
of this section shall be implemented no later than December 31, 2008.

                      Appendix A to Sec. 1910.1026

       In the United States Court of Appeals for the Third Circuit

    Surface Finishing Industry Council et al., Petitioners, v. U.S. 
       Occupational Safety and Health Administration, Respondent.

               [Docket No. 06-2272 and consolidated cases]

      Public Citizen Health Research Group et al., Petitioners, v. 
Occupational Safety and Health Administration, United States Department 
                          of Labor, Respondent.

                          [Docket No. 06-1818]

                          Settlement Agreement

    The parties to this Settlement Agreement (``Agreement'') are the 
Occupational Safety and Health Administration, United States Department 
of Labor (``OSHA''), the Surface Finishing Industry Council or its 
successors (``SFIC''), surface-finishing and metal-finishing facilities 
which have opted into this Agreement pursuant to paragraph 7 
(``Company'' or ``Companies''), Public Citizen Health Research Group 
(``HRG''), and the United Steel, Paper and Forestry, Rubber, 
Manufacturing, Energy, Allied Industrial and Service Workers 
International Union (``Steelworkers'').
    Whereas, On February 28, 2006, OSHA promulgated a revised hexavalent 
chromium standard for general industry (``the Standard'') that includes 
a permissible exposure limit (``PEL'') for hexavalent chromium of 5 
micrograms per cubic meter (``[mu]g/m\3\'') measured as

[[Page 138]]

an 8-hour time-weighted average (``TWA''), and a deadline of May 31, 
2010, for employers to come into compliance with this PEL through the 
implementation of engineering controls. The deadline for compliance with 
the remaining provisions of the Standard, including those requiring the 
use of respiratory protection to comply with the PEL, is November 27, 
2006, for employers with twenty (20) or more employees, and May 30, 
2007, for employers with nineteen (19) or fewer employees. 29 CFR 
1910.1026, 71 FR 10100 (Feb. 28, 2006);
    Whereas, SFIC filed a Petition for Review of the Standard in the 
Eleventh Circuit that was consolidated with other Petitions in the Third 
Circuit (Case No. 06-2272);
    Whereas, SFIC filed a Motion for Leave to Intervene in the matter of 
HRG's Petition for Review in the Third Circuit (Case No. 06-1818), which 
has been granted;
    Now, therefore, the parties to this Agreement do hereby agree to the 
following terms:
    1. Term of this Agreement. This Agreement will be effective upon 
execution and will expire on May 31, 2010.
    2. Accelerated implementation of engineering controls. The Companies 
agree that in accordance with 29 CFR 1910.1026(f)(1) they will implement 
those feasible engineering controls necessary to reduce hexavalent 
chromium levels at their facilities by December 31, 2008, to or below 
the 5 [mu]g/m\3\ PEL. In fulfilling this obligation, the Companies may 
select from the engineering and work practice controls listed in Exhibit 
A to this Agreement or adopt any other controls.
    3. Compliance plan and monitoring. In accordance with 29 CFR 
1910.1026(d)(4)(ii), each Company will prepare, and update as required, 
a written plan setting forth the specific control steps being taken to 
reduce employee exposure to or below the PEL by December 31, 2008. In 
addition, Companies will make an initial exposure determination as 
required by 29 CFR 1910.1026(d)(1) using either the procedures for 
personal breathing zone air samples described in 29 CFR 1910.1026(d)(2) 
or the performance-oriented option described at 29 CFR 1910.1026(d)(3). 
Thereafter, Companies will conduct periodic monitoring in accordance 
with the ``Scheduled Monitoring Option'' provisions at 29 CFR 
1910.1026(d)(2) and related provisions at 29 CFR 1910.1026(d)(4)-(6). 
The Companies agree that upon request compliance plans prepared in 
accordance with this paragraph, as well as all monitoring results 
obtained in compliance with this paragraph, will be provided to OSHA, 
affected employees and employee representatives.
    4. Respirator use. The respiratory protection provisions at 29 CFR 
1910.1026(f) and (g) will apply to the Companies in accordance with the 
terms and dates set forth in the Standard, except that prior to December 
31, 2008, for Companies that are in compliance with this Agreement, OSHA 
will enforce those respiratory protection provisions only with respect 
to employees who fall into one of the following six (6) categories: (1) 
Employees who are exposed to hexavalent chromium in excess of the PEL 
while performing tasks described in Exhibit B to this Agreement; (2) 
through November 30, 2007, employees whose exposures to hexavalent 
chromium exceed a ``respirator threshold'' of 20 [mu]g/m\3\ (measured as 
an 8-hour TWA); (3) beginning December 1, 2007, employees whose 
exposures to hexavalent chromium exceed a ``respirator threshold'' of 
12.5 [mu]g/m\3\ (measured as an 8-hour TWA); (4) employees who are 
exposed to hexavalent chromium and request a respirator; (5) any other 
employees who are required by the Companies to wear a respirator; and 
(6) employees with exposures for which respirators were required under 
the previous hexavalent chromium standard (1910.1000) and any other 
employees covered by respirator programs in effect on May 30, 2006.
    5. Employee information and training. Company employees will be 
trained pursuant to the provisions of 29 CFR 1910.1026(l)(2). In 
addition, the Companies agree to train employees in the provisions of 
this Agreement within sixty (60) days of the Opt-In Date (defined in 
paragraph 7 of this Agreement). The training regarding this Agreement 
shall be provided in language the employees can understand.

[[Page 139]]

    6. Enforcement. Within thirty (30) days of the execution of this 
Agreement, OSHA will publish a notice in the Federal Register amending 
29 CFR 1910.1026 as follows: (1) A copy of this Agreement will be 
attached to the Standard as Appendix A; (2) a new paragraph, 
1910.1026(n)(4), will be added to the Standard, and will read: ``In 
facilities that become parties to the settlement agreement included in 
Appendix A, engineering controls required by paragraph (f) of this 
section shall be implemented no later than December 31, 2008''; and (3) 
existing paragraph 1910.1026(n)(3) will be amended to read: ``Except as 
provided in (n)(4), for all employers, engineering controls required by 
paragraph (f) of this section shall be implemented no later than May 31, 
2010.''
    7. Opt-In Date for Companies to become parties to this Agreement. 
The Federal Register notice described in paragraph 6 of this Agreement 
will provide notice of the provisions of this Agreement, and of the 
revisions to the Standard described in paragraph 6, and will provide 
until November 30, 2006, for eligible facilities to become parties to 
this Agreement, and be subject to all of the duties, obligations, and 
rights herein. The last date for signing by facilities shall be referred 
to as the Opt-In Date. The opt in option will be available on a facility 
by facility basis and only to SFIC members and other surface-finishing 
and metal-finishing job shop facilities within the jurisdiction of 
Federal OSHA. (For purposes of this Agreement, a ``job shop'' is defined 
as a facility that sells plating or anodizing services to other 
companies.) Moreover, the terms of this Agreement apply only with 
respect to the performance of surface-finishing and metal-finishing 
operations in those facilities. Although this Agreement applies only to 
facilities within the jurisdiction of Federal OSHA, OSHA will encourage 
States with OSHA-approved State occupational safety and health plans to 
either honor and implement the terms of this Agreement, including the 
amendments to the standard described in paragraph 6, or to take an 
alternative position, which may include entering into separate 
arrangements with surface- and metal-finishing job shop facilities (or 
their representatives) in their jurisdiction.
    8. Effect on third parties. Nothing in this Agreement constitutes an 
admission by SFIC or the Companies that a significant risk of material 
health impairment exists for hexavalent chromium justifying a reduction 
of the PEL to 5 [mu]g/m\3\. Nor does anything in this Agreement 
constitute any other admission by SFIC or the Companies for purposes of 
this litigation or future litigation or standards-setting. This 
Agreement is not intended to give any rights to any third party except 
as expressly provided herein.
    9. OSHA inspections. OSHA may do monitoring inspections to assess 
compliance with and progress under this Agreement and the Standard, and 
nothing in this Agreement limits OSHA's right to conduct inspections at 
Companies'' facilities in accordance with the Occupational Safety and 
Health Act.
    10. Scope of Agreement. The terms of this Agreement apply only in 
the circumstances and to the Companies specified herein. In entering 
into this Agreement, OSHA is not making any representations regarding 
its enforcement policy with respect to either (1) The hexavalent 
chromium standard as applied to employers who are not parties to this 
Agreement or (2) any other occupational safety or health standards.
    11. Effect of invalidation of the Standard. If the Standard is 
invalidated, nothing in this Agreement shall prevent the application to 
SFIC or the Companies of any PEL that is promulgated by OSHA on remand. 
This Agreement would not foreclose SFIC or the Companies from 
participating in rulemaking proceedings or otherwise challenging any new 
PEL promulgated by OSHA on remand.
    12. Withdrawal of Petitions and Interventions. SFIC agrees to move 
to withdraw its Petition for Review in the above-captioned case, Case 
No. 06-2272, within five (5) working days of the execution of this 
Agreement. SFIC further will move to dismiss its motion to intervene in 
Case No. 06-1818 and all other challenges simultaneously with its motion 
to withdraw in Case No. 06-2272 as Petitioner.

[[Page 140]]

    13. Attorneys' fees. Each party agrees to bear its own attorneys' 
fees, costs, and other expenses that have been incurred in connection 
with SFIC's Petition for Review, SFIC's intervention in HRG's Petition 
for Review, and the negotiation of this Agreement up to and including 
filing of the motions to dismiss.
    14. Support of Agreement. In the event that all or any portion of 
this Agreement is challenged in any forum, the signatories below agree 
to move to intervene in support of this Agreement.
    Agreed to this 25th day of October, 2006.

Baruch A. Fellner,

Counsel for SFIC, Gibson, Dunn & Crutcher LLP, 1050 Connecticut Avenue, 
    NW., Washington, DC 20036, (202) 955-8500.

Lauren S. Goodman,

Counsel for OSHA, United States Department of Labor, Office of the 
    Solicitor, 200 Constitution Avenue, NW., Washington, DC 20210, (202) 
    693-5445.

Scott L. Nelson,

Counsel for HRG and the Steelworkers, Public Citizen Litigation Group, 
    1600 20th Street, NW., Washington, DC 20009, (202) 588-7724.

                                Exhibit A

            Available Engineering and Work Practice Controls

    The Companies agree that work towards the implementation of these 
available engineering and work practice controls should not be delayed 
to accommodate their completion by December 31, 2008. The Companies are 
encouraged to implement from among these controls as soon as 
practicable.

                       1. Parts Transfer Practices

     Minimize droplet formation. Instruments akin to 
garden hoses are used to rinse off parts coming out of chemical baths. 
This causes many small droplets to form, which are easily atomized or 
vaporized and contribute to airborne chromium concentration. The 
industry is currently developing ways to minimize the formation of small 
droplets, dripping, or splashing, possibly by reducing hose pressure.
     Minimize air current flow. Strong air currents 
across these droplets may contribute to their vaporization, and 
therefore minimizing air current flow across the droplets may reduce 
airborne hexavalent chromium levels.
     Slow part speeds as feasible. The speed at which 
parts are pulled out of a chemical tank causes splashing, which adds to 
chromium vaporization. By slowing the speed at which parts are taken out 
of tanks, splashing and vaporization can be minimized. The feasibility 
of this control must be evaluated in light of the negative effect on 
productivity.

     2. Plating Bath Surface Tension Management and Fume Suppression

     Lower surface tension. Lower surface tension in 
chemical baths leads to fewer drops forming. Chromium baths currently 
have a surface tension of 35 dynes per centimeter. As a comparison, 
water has a surface tension of 72 dynes per centimeter. Lowering surface 
tension further would lead to reduced airborne hexavalent chromium 
levels.
     Fume suppressants. Fume suppressants create a 
physical barrier between the chemical bath and the air, which prevents 
vaporization. Some suppressants, however, may cause pitting or other 
metal damage, and therefore their use is not always possible.

                 3. Facility Air Disturbance Monitoring

     Improvement of local exhaust ventilation (LEV) 
capture efficiency. The majority of electroplating facilities are not 
air-conditioned. As a result, doors are kept open to let in cool air, 
but this causes air currents that prevent the LEVs from performing 
efficiently. The use of fans has a similar effect. Industry is 
researching how to minimize these air currents so that LEVs can perform 
as designed. Such methods may include the use of partitions to degrade 
air current flow, or checklists that may include location and 
positioning of cross drafts, fans, doors, windows, partitions and 
process equipment that Companies can use to audit their workplaces in 
order to improve their capture efficiency.

[[Page 141]]

         4. Technology Enhancements In Lieu of LEV Retrofitting

     Eductors. Many chemical baths are currently mixed 
via air agitation: Air pipes bubble air into the tank to keep the 
chemicals mixed and to prevent them from settling. An adverse effect of 
this agitation is that air bubbles escape at the surface of the tank, 
resulting in some chromium vaporization. By using eductors (horn-shaped 
nozzles) in tanks, the chemicals flow from a pump to create solution 
movement below the surface without the use of air bubbles, and the 
amount of chromium vaporization can be significantly reduced.

                5. Different Means of Chromium Additions

     Liquid Chromium. Dry hexavalent chromium flakes 
are occasionally added to tanks, which can generate airborne 
particulates of hexavalent chromium. Adding liquid chromium at or near 
the surface of a tank would lower airborne chromium levels and reduce 
splashing from tanks.
     Hydration of flakes before addition. To add 
liquid chromium to tanks, the dry flakes must be hydrated. Whether this 
process is performed by chemical suppliers that provide plating 
solutions to metal finishing companies or by metal finishing companies 
that have the necessary experience and equipment, appropriate work 
practices such as mixing techniques must be implemented to minimize the 
potential airborne levels of hexavalent chromium.

                             6. Dust Control

     Better housekeeping. Chrome dust that comes off 
products that are polished or grinded is actually elemental chromium, 
not hexavalent chromium, so polishing and grinding contribute little to 
airborne hexavalent chromium levels. However, Companies should use good 
housekeeping practices, including wet mopping, and wet wipedowns, to 
reduce the amount of dust present.

             7. Improvement and Maintenance of Existing LEVs

     Improvement and maintenance of existing LEVs. 
Companies may repair and maintain their current LEVs. Because the final 
rule indicates that at least 75 percent of the industry is in compliance 
with the PEL with LEVs working at 40% of capacity, increasing LEV 
function can materially affect compliance.

                            8. Other Controls

     Other methods. Companies are constantly 
determining best work practices and technological controls through 
laboratory research and practical experience. Companies will implement 
other engineering and work practice controls as necessary and as 
practicable to reduce potential hexavalent chromium workplace exposures.

                                Exhibit B

       Workplace Tasks Requiring Respirators Where PEL Is Exceeded

    Some well-known and relatively few, discrete tasks related to metal 
finishing activities result in potentially higher workplace exposures of 
hexavalent chromium. Where the applicable PEL for hexavalent chromium is 
exceeded, respirators shall be worn to conduct the following activities:
    (1) Hexavalent chromium chemical additions. In order to have the 
metal deposited onto the part, hexavalent chromium must be added to the 
plating tank periodically. This is a discrete activity that involves the 
addition of either a dry flake of hexavalent chromium chemicals or a 
liquid solution of hexavalent chromium into the plating tank. 
Respirators shall be worn during the period it takes to add the 
hexavalent chromium chemical to the tank.
    (2) Hexavalent chromium preparation and mixing. Different mixtures 
of hexavalent chromium chemicals are needed for different types of 
chromium plating processes. For example, hard chromium plating can 
require higher concentrations of hexavalent chromium because a thicker 
coating and longer plating process may be needed for the critical 
product quality and performance. Similarly, different types of 
decorative chromium plating processes may need different levels of 
hexavalent chromium and other chemicals such as catalysts. These 
mixtures can be in the form of dry flakes or liquid solutions. All of 
these different

[[Page 142]]

hexavalent chromium chemical mixtures are generally prepared by metal 
finishing suppliers and distributors. Some metal finishing companies may 
also prepare hexavalent chromium solutions from the dry flakes prior to 
addition to the plating tanks. Respirators shall be worn during the 
period it takes to prepare these hexavalent chromium mixtures and 
solutions whether the activity is conducted at a chemical supplier or a 
metal finishing company.
    (3) Hexavalent chromium tank cleaning. Occasionally, the tanks used 
for chromium plating may need to be emptied and cleaned. This process 
would involve the draining of the solution and then the removal of any 
residues in the tank. Workers cleaning out these tanks may have to enter 
the tank or reach into it to remove the residues. Respirators (as well 
as other appropriate PPE) shall be worn during the period it takes to 
clean the tanks and prepare them for use again.
    (4) Hexavalent chromium painting operations. Some metal finishing 
operations apply paints with higher concentrations of hexavalent 
chromium to a line of parts, particularly for aerospace applications 
when a high degree of corrosion protection is needed for critical 
product performance. Paints are generally applied in such operations 
with some type of spray mechanism or similar dispersion practice. In 
some instances, it may be difficult to keep workplace exposures below 
the PEL for such paint spraying activities. Respirators shall be worn 
during such spray painting operations.

[71 FR 10374, Feb. 28, 2006, as amended at 71 FR 63242, Oct. 30, 2006; 
73 FR 75585, Dec. 12, 2008]



Sec. 1910.1027  Cadmium.

    (a) Scope. This standard applies to all occupational exposures to 
cadmium and cadmium compounds, in all forms, and in all industries 
covered by the Occupational Safety and Health Act, except the 
construction-related industries, which are covered under 29 CFR 1926.63.
    (b) Definitions. Action level (AL) is defined as an airborne 
concentration of cadmium of 2.5 micrograms per cubic meter of air (2.5 
[micro]g/m\3\), calculated as an 8-hour time-weighted average (TWA).
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, U.S. Department of Labor, or designee.
    Authorized person means any person authorized by the employer and 
required by work duties to be present in regulated areas or any person 
authorized by the OSH Act or regulations issued under it to be in 
regulated areas.
    Director means the Director of the National Institute for 
Occupational Safety and Health (NIOSH), U.S. Department of Health and 
Human Services, or designee.
    Employee exposure and similar language referring to the air cadmium 
level to which an employee is exposed means the exposure to airborne 
cadmium that would occur if the employee were not using respiratory 
protective equipment.
    Final medical determination is the written medical opinion of the 
employee's health status by the examining physician under paragraphs 
(l)(3)-(12) of this section or, if multiple physician review under 
paragraph (l)(13) of this section or the alternative physician 
determination under paragraph (l)(14) of this section is invoked, it is 
the final, written medical finding, recommendation or determination that 
emerges from that process.
    High-efficiency particulate air (HEPA) filter means a filter capable 
of trapping and retaining at least 99.97 percent of mono-dispersed 
particles of 0.3 micrometers in diameter.
    Regulated area means an area demarcated by the employer where an 
employee's exposure to airborne concentrations of cadmium exceeds, or 
can reasonably be expected to exceed the permissible exposure limit 
(PEL).
    This section means this cadmium standard.
    (c) Permissible Exposure Limit (PEL). The employer shall assure that 
no employee is exposed to an airborne concentration of cadmium in excess 
of five micrograms per cubic meter of air (5 [micro]g/m\3\), calculated 
as an eight-hour time-weighted average exposure (TWA).
    (d) Exposure monitoring--(1) General. (i) Each employer who has a 
workplace

[[Page 143]]

or work operation covered by this section shall determine if any 
employee may be exposed to cadmium at or above the action level.
    (ii) Determinations of employee exposure shall be made from 
breathing zone air samples that reflect the monitored employee's 
regular, daily 8-hour TWA exposure to cadmium.
    (iii) Eight-hour TWA exposures shall be determined for each employee 
on the basis of one or more personal breathing zone air samples 
reflecting full shift exposure on each shift, for each job 
classification, in each work area. Where several employees perform the 
same job tasks, in the same job classification, on the same shift, in 
the same work area, and the length, duration, and level of cadmium 
exposures are similar, an employer may sample a representative fraction 
of the employees instead of all employees in order to meet this 
requirement. In representative sampling, the employer shall sample the 
employee(s) expected to have the highest cadmium exposures.
    (2) Specific. (i) Initial monitoring. Except as provided for in 
paragraphs (d)(2)(ii) and (d)(2)(iii) of this section, the employer 
shall monitor employee exposures and shall base initial determinations 
on the monitoring results.
    (ii) Where the employer has monitored after September 14, 1991, 
under conditions that in all important aspects closely resemble those 
currently prevailing and where that monitoring satisfies all other 
requirements of this section, including the accuracy and confidence 
levels of paragraph (d)(6) of this section, the employer may rely on 
such earlier monitoring results to satisfy the requirements of paragraph 
(d)(2)(i) of this section.
    (iii) Where the employer has objective data, as defined in paragraph 
(n)(2) of this section, demonstrating that employee exposure to cadmium 
will not exceed the action level under the expected conditions of 
processing, use, or handling, the employer may rely upon such data 
instead of implementing initial monitoring.
    (3) Monitoring Frequency (periodic monitoring). (i) If the initial 
monitoring or periodic monitoring reveals employee exposures to be at or 
above the action level, the employer shall monitor at a frequency and 
pattern needed to represent the levels of exposure of employees and 
where exposures are above the PEL to assure the adequacy of respiratory 
selection and the effectiveness of engineering and work practice 
controls. However, such exposure monitoring shall be performed at least 
every six months. The employer, at a minimum, shall continue these semi-
annual measurements unless and until the conditions set out in paragraph 
(d)(3)(ii) of this section are met.
    (ii) If the initial monitoring or the periodic monitoring indicates 
that employee exposures are below the action level and that result is 
confirmed by the results of another monitoring taken at least seven days 
later, the employer may discontinue the monitoring for those employees 
whose exposures are represented by such monitoring.
    (4) Additional Monitoring. The employer also shall institute the 
exposure monitoring required under paragraphs (d)(2)(i) and (d)(3) of 
this section whenever there has been a change in the raw materials, 
equipment, personnel, work practices, or finished products that may 
result in additional employees being exposed to cadmium at or above the 
action level or in employees already exposed to cadmium at or above the 
action level being exposed above the PEL, or whenever the employer has 
any reason to suspect that any other change might result in such further 
exposure.
    (5) Employee Notification of Monitoring Results. (i) The employer 
must, within 15 working days after the receipt of the results of any 
monitoring performed under this section, notify each affected employee 
of these results either individually in writing or by posting the 
results in an appropriate location that is accessible to employees.
    (ii) Wherever monitoring results indicate that employee exposure 
exceeds the PEL, the employer shall include in the written notice a 
statement that the PEL has been exceeded and a description of the 
corrective action being taken by the employer to reduce employee 
exposure to or below the PEL.
    (6) Accuracy of measurement. The employer shall use a method of 
monitoring and analysis that has an accuracy of not less than plus or 
minus 25

[[Page 144]]

percent (25%), with a confidence level of 95 
percent, for airborne concentrations of cadmium at or above the action 
level, the permissible exposure limit (PEL), and the separate 
engineering control air limit (SECAL).
    (e) Regulated areas--(1) Establishment. The employer shall establish 
a regulated area wherever an employee's exposure to airborne 
concentrations of cadmium is, or can reasonably be expected to be in 
excess of the permissible exposure limit (PEL).
    (2) Demarcation. Regulated areas shall be demarcated from the rest 
of the workplace in any manner that adequately establishes and alerts 
employees of the boundaries of the regulated area.
    (3) Access. Access to regulated areas shall be limited to authorized 
persons.
    (4) Provision of respirators. Each person entering a regulated area 
shall be supplied with and required to use a respirator, selected in 
accordance with paragraph (g)(2) of this section.
    (5) Prohibited activities. The employer shall assure that employees 
do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in 
regulated areas, carry the products associated with these activities 
into regulated areas, or store such products in those areas.
    (f) Methods of compliance--(1) Compliance hierarchy. (i) Except as 
specified in paragraphs (f)(1) (ii), (iii) and (iv) of this section the 
employer shall implement engineering and work practice controls to 
reduce and maintain employee exposure to cadmium at or below the PEL, 
except to the extent that the employer can demonstrate that such 
controls are not feasible.
    (ii) Except as specified in paragraphs (f)(1) (iii) and (iv) of this 
section, in industries where a separate engineering control air limit 
(SECAL) has been specified for particular processes (See Table 1 in this 
paragraph (f)(1)(ii)), the employer shall implement engineering and work 
practice controls to reduce and maintain employee exposure at or below 
the SECAL, except to the extent that the employer can demonstrate that 
such controls are not feasible.

   Table I--Separate Engineering Control Airborne Limits (SECALs) for
                    Processes in Selected Industries
------------------------------------------------------------------------
                                                                 SECAL
             Industry                       Process           ([micro]g/
                                                                 m\3\)
------------------------------------------------------------------------
Nickel cadmium battery...........  Plate making, plate                50
                                    preparation.
                                   All other processes......          15
Zinc/Cadmium refining*...........  Cadmium refining,                  50
                                    casting, melting, oxide
                                    production, sinter plant.
Pigment manufacture..............  Calcine, crushing,                 50
                                    milling, blending.
                                   All other processes......          15
Stabilizers*.....................  Cadmium oxide charging,            50
                                    crushing, drying,
                                    blending.
Lead smelting*...................  Sinter plant, blast                50
                                    furnace, baghouse, yard
                                    area.
Plating*.........................  Mechanical plating.......          15
------------------------------------------------------------------------
*Processes in these industries that are not specified in this table must
  achieve the PEL using engineering controls and work practices as
  required in f(1)(i).

    (iii) The requirement to implement engineering and work practice 
controls to achieve the PEL or, where applicable, the SECAL does not 
apply where the employer demonstrates the following:
    (A) The employee is only intermittently exposed; and
    (B) The employee is not exposed above the PEL on 30 or more days per 
year (12 consecutive months).
    (iv) Wherever engineering and work practice controls are required 
and are not sufficient to reduce employee exposure to or below the PEL 
or, where applicable, the SECAL, the employer nonetheless shall 
implement such controls to reduce exposures to the lowest levels 
achievable. The employer shall supplement such controls with respiratory 
protection that complies with the requirements of paragraph (g) of this 
section and the PEL.
    (v) The employer shall not use employee rotation as a method of 
compliance.
    (2) Compliance program. (i) Where the PEL is exceeded, the employer 
shall establish and implement a written compliance program to reduce 
employee exposure to or below the PEL by means

[[Page 145]]

of engineering and work practice controls, as required by paragraph 
(f)(1) of this section. To the extent that engineering and work practice 
controls cannot reduce exposures to or below the PEL, the employer shall 
include in the written compliance program the use of appropriate 
respiratory protection to achieve compliance with the PEL.
    (ii) Written compliance programs shall include at least the 
following:
    (A) A description of each operation in which cadmium is emitted; 
e.g., machinery used, material processed, controls in place, crew size, 
employee job responsibilities, operating procedures, and maintenance 
practices;
    (B) A description of the specific means that will be employed to 
achieve compliance, including engineering plans and studies used to 
determine methods selected for controlling exposure to cadmium, as well 
as, where necessary, the use of appropriate respiratory protection to 
achieve the PEL;
    (C) A report of the technology considered in meeting the PEL;
    (D) Air monitoring data that document the sources of cadmium 
emissions;
    (E) A detailed schedule for implementation of the program, including 
documentation such as copies of purchase orders for equipment, 
construction contracts, etc.;
    (F) A work practice program that includes items required under 
paragraphs (h), (i), and (j) of this section;
    (G) A written plan for emergency situations, as specified in 
paragraph (h) of this section; and
    (H) Other relevant information.
    (iii) The written compliance programs shall be reviewed and updated 
at least annually, or more often if necessary, to reflect significant 
changes in the employer's compliance status.
    (iv) Written compliance programs shall be provided upon request for 
examination and copying to affected employees, designated employee 
representatives as well as to the Assistant Secretary, and the Director.
    (3) Mechanical ventilation. (i) When ventilation is used to control 
exposure, measurements that demonstrate the effectiveness of the system 
in controlling exposure, such as capture velocity, duct velocity, or 
static pressure shall be made as necessary to maintain its 
effectiveness.
    (ii) Measurements of the system's effectiveness in controlling 
exposure shall be made as necessary within five working days of any 
change in production, process, or control that might result in a 
significant increase in employee exposure to cadmium.
    (iii) Recirculation of air. If air from exhaust ventilation is 
recirculated into the workplace, the system shall have a high efficiency 
filter and be monitored to assure effectiveness.
    (iv) Procedures shall be developed and implemented to minimize 
employee exposure to cadmium when maintenance of ventilation systems and 
changing of filters is being conducted.
    (g) Respiratory protection--(1) General. For employees who use 
respirators required by this section, the employer must provide each 
employee an appropriate respirator that complies with the requirements 
of this paragraph. Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls when employee exposure levels exceed the PEL.
    (ii) Maintenance and repair activities, and brief or intermittent 
operations, for which employee exposures exceed the PEL and engineering 
and work-practice controls are not feasible or are not required.
    (iii) Activities in regulated areas specified in paragraph (e) of 
this section.
    (iv) Work operations for which the employer has implemented all 
feasible engineering and work-practice controls and such controls are 
not sufficient to reduce employee exposures to or below the PEL.
    (v) Work operations for which an employee is exposed to cadmium at 
or above the action level, and the employee requests a respirator.
    (vi) Work operations for which an employee is exposed to cadmium 
above the PEL and engineering controls are not required by paragraph 
(f)(1)(ii) of this section.
    (vii) Emergencies.

[[Page 146]]

    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with Sec. 1910.134(b) 
through (d) (except (d)(1)(iii)), and (f) through (m), which covers each 
employee required by this section to use a respirator.
    (ii) No employees must use a respirator if, based on their most 
recent medical examination, the examining physician determines that they 
will be unable to continue to function normally while using a 
respirator. If the physician determines that the employee must be 
limited in, or removed from, their current job because of their 
inability to use a respirator, the limitation or removal must be in 
accordance with paragraphs (l) (11) and (12) of this section.
    (iii) If an employee has breathing difficulty during fit testing or 
respirator use, the employer must provide the employee with a medical 
examination in accordance with paragraph (l)(6)(ii) of this section to 
determine if the employee can use a respirator while performing the 
required duties.
    (3) Respirator selection. (i) Employers must:
    (A) Select, and provide to employees, the appropriate respirators 
specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134.
    (B) Provide employees with full facepiece respirators when they 
experience eye irritation.
    (C) Provide HEPA filters for powered and non-powered air-purifying 
respirators.
    (ii) The employer must provide an employee with a powered air-
purifying respirator instead of a negative-pressure respirator when an 
employee who is entitled to a respirator chooses to use this type of 
respirator and such a respirator provides adequate protection to the 
employee.
    (h) Emergency situations. The employer shall develop and implement a 
written plan for dealing with emergency situations involving substantial 
releases of airborne cadmium. The plan shall include provisions for the 
use of appropriate respirators and personal protective equipment. In 
addition, employees not essential to correcting the emergency situation 
shall be restricted from the area and normal operations halted in that 
area until the emergency is abated.
    (i) Protective work clothing and equipment--(1) Provision and use. 
If an employee is exposed to airborne cadmium above the PEL or where 
skin or eye irritation is associated with cadmium exposure at any level, 
the employer shall provide at no cost to the employee, and assure that 
the employee uses, appropriate protective work clothing and equipment 
that prevents contamination of the employee and the employee's garments. 
Protective work clothing and equipment includes, but is not limited to:
    (i) Coveralls or similar full-body work clothing;
    (ii) Gloves, head coverings, and boots or foot coverings; and
    (iii) Face shields, vented goggles, or other appropriate protective 
equipment that complies with 29 CFR 1910.133.
    (2) Removal and storage. (i) The employer shall assure that 
employees remove all protective clothing and equipment contaminated with 
cadmium at the completion of the work shift and do so only in change 
rooms provided in accordance with paragraph (j)(1) of this section.
    (ii) The employer shall assure that no employee takes cadmium-
contaminated protective clothing or equipment from the workplace, except 
for employees authorized to do so for purposes of laundering, cleaning, 
maintaining, or disposing of cadmium contaminated protective clothing 
and equipment at an appropriate location or facility away from the 
workplace.
    (iii) The employer shall assure that contaminated protective 
clothing and equipment, when removed for laundering, cleaning, 
maintenance, or disposal, is placed and stored in sealed, impermeable 
bags or other closed, impermeable containers that are designed to 
prevent dispersion of cadmium dust.
    (iv) The employer shall assure that bags or containers of 
contaminated protective clothing and equipment that are to be taken out 
of the change rooms or the workplace for laundering, cleaning, 
maintenance or disposal shall bear labels in accordance with paragraph 
(m)(3) of this section.

[[Page 147]]

    (3) Cleaning, replacement, and disposal. (i) The employer shall 
provide the protective clothing and equipment required by paragraph 
(i)(1) of this section in a clean and dry condition as often as 
necessary to maintain its effectiveness, but in any event at least 
weekly. The employer is responsible for cleaning and laundering the 
protective clothing and equipment required by this paragraph to maintain 
its effectiveness and is also responsible for disposing of such clothing 
and equipment.
    (ii) The employer also is responsible for repairing or replacing 
required protective clothing and equipment as needed to maintain its 
effectiveness. When rips or tears are detected while an employee is 
working they shall be immediately mended, or the worksuit shall be 
immediately replaced.
    (iii) The employer shall prohibit the removal of cadmium from 
protective clothing and equipment by blowing, shaking, or any other 
means that disperses cadmium into the air.
    (iv) The employer shall assure that any laundering of contaminated 
clothing or cleaning of contaminated equipment in the workplace is done 
in a manner that prevents the release of airborne cadmium in excess of 
the permissible exposure limit prescribed in paragraph (c) of this 
section.
    (v) The employer shall inform any person who launders or cleans 
protective clothing or equipment contaminated with cadmium of the 
potentially harmful effects of exposure to cadmium and that the clothing 
and equipment should be laundered or cleaned in a manner to effectively 
prevent the release of airborne cadmium in excess of the PEL.
    (j) Hygiene areas and practices--(1) General. For employees whose 
airborne exposure to cadmium is above the PEL, the employer shall 
provide clean change rooms, handwashing facilities, showers, and 
lunchroom facilities that comply with 29 CFR 1910.141.
    (2) Change rooms. The employer shall assure that change rooms are 
equipped with separate storage facilities for street clothes and for 
protective clothing and equipment, which are designed to prevent 
dispersion of cadmium and contamination of the employee's street 
clothes.
    (3) Showers and handwashing facilities. (i) The employer shall 
assure that employees who are exposed to cadmium above the PEL shower 
during the end of the work shift.
    (ii) The employer shall assure that employees whose airborne 
exposure to cadmium is above the PEL wash their hands and faces prior to 
eating, drinking, smoking, chewing tobacco or gum, or applying 
cosmetics.
    (4) Lunchroom facilities. (i) The employer shall assure that the 
lunchroom facilities are readily accessible to employees, that tables 
for eating are maintained free of cadmium, and that no employee in a 
lunchroom facility is exposed at any time to cadmium at or above a 
concentration of 2.5 [micro]g/m\3\.
    (ii) The employer shall assure that employees do not enter lunchroom 
facilities with protective work clothing or equipment unless surface 
cadmium has been removed from the clothing and equipment by HEPA 
vacuuming or some other method that removes cadmium dust without 
dispersing it.
    (k) Housekeeping. (1) All surfaces shall be maintained as free as 
practicable of accumulations of cadmium.
    (2) All spills and sudden releases of material containing cadmium 
shall be cleaned up as soon as possible.
    (3) Surfaces contaminated with cadmium shall, wherever possible, be 
cleaned by vacuuming or other methods that minimize the likelihood of 
cadmium becoming airborne.
    (4) HEPA-filtered vacuuming equipment or equally effective 
filtration methods shall be used for vacuuming. The equipment shall be 
used and emptied in a manner that minimizes the reentry of cadmium into 
the workplace.
    (5) Shoveling, dry or wet sweeping, and brushing may be used only 
where vacuuming or other methods that minimize the likelihood of cadmium 
becoming airborne have been tried and found not to be effective.
    (6) Compressed air shall not be used to remove cadmium from any 
surface unless the compressed air is used in conjunction with a 
ventilation system designed to capture the dust cloud created by the 
compressed air.
    (7) Waste, scrap, debris, bags, containers, personal protective 
equipment,

[[Page 148]]

and clothing contaminated with cadmium and consigned for disposal shall 
be collected and disposed of in sealed impermeable bags or other closed, 
impermeable containers. These bags and containers shall be labeled in 
accordance with paragraph (m)(2) of this section.
    (l) Medical surveillance--(1) General--(i) Scope. (A) Currently 
exposed--The employer shall institute a medical surveillance program for 
all employees who are or may be exposed to cadmium at or above the 
action level unless the employer demonstrates that the employee is not, 
and will not be, exposed at or above the action level on 30 or more days 
per year (twelve consecutive months); and,
    (B) Previously exposed--The employer shall also institute a medical 
surveillance program for all employees who prior to the effective date 
of this section might previously have been exposed to cadmium at or 
above the action level by the employer, unless the employer demonstrates 
that the employee did not prior to the effective date of this section 
work for the employer in jobs with exposure to cadmium for an aggregated 
total of more than 60 months.
    (ii) To determine an employee's fitness for using a respirator, the 
employer shall provide the limited medical examination specified in 
paragraph (l)(6) of this section.
    (iii) The employer shall assure that all medical examinations and 
procedures required by this standard are performed by or under the 
supervision of a licensed physician, who has read and is familiar with 
the health effects section of appendix A to this section, the regulatory 
text of this section, the protocol for sample handling and laboratory 
selection in appendix F to this section, and the questionnaire of 
appendix D to this section. These examinations and procedures shall be 
provided without cost to the employee and at a time and place that is 
reasonable and convenient to employees.
    (iv) The employer shall assure that the collecting and handling of 
biological samples of cadmium in urine (CdU), cadmium in blood (CdB), 
and beta-2 microglobulin in urine ([beta]2-M) taken from 
employees under this section is done in a manner that assures their 
reliability and that analysis of biological samples of cadmium in urine 
(CdU), cadmium in blood (CdB), and beta-2 microglobulin in urine 
([beta]2-M) taken from employees under this section is 
performed in laboratories with demonstrated proficiency for that 
particular analyte. (See appendix F to this section.)
    (2) Initial examination. (i) The employer shall provide an initial 
(preplacement) examination to all employees covered by the medical 
surveillance program required in paragraph (l)(1)(i) of this section. 
The examination shall be provided to those employees within 30 days 
after initial assignment to a job with exposure to cadmium or no later 
than 90 days after the effective date of this section, whichever date is 
later.
    (ii) The initial (preplacement) medical examination shall include:
    (A) A detailed medical and work history, with emphasis on: Past, 
present, and anticipated future exposure to cadmium; any history of 
renal, cardiovascular, respiratory, hematopoietic, reproductive, and/or 
musculo-skeletal system dysfunction; current usage of medication with 
potential nephrotoxic side-effects; and smoking history and current 
status; and
    (B) Biological monitoring that includes the following tests:
    (1) Cadmium in urine (CdU), standardized to grams of creatinine (g/
Cr);
    (2) Beta-2 microglobulin in urine ([beta]2-M), 
standardized to grams of creatinine (g/Cr), with pH specified, as 
described in appendix F to this section; and
    (3) Cadmium in blood (CdB), standardized to liters of whole blood 
(lwb).
    (iii) Recent Examination: An initial examination is not required to 
be provided if adequate records show that the employee has been examined 
in accordance with the requirements of paragraph (l)(2)(ii) of this 
section within the past 12 months. In that case, such records shall be 
maintained as part of the employee's medical record and the prior exam 
shall be treated as if it were an initial examination for the purposes 
of paragraphs (l)(3) and (4) of this section.

[[Page 149]]

    (3) Actions triggered by initial biological monitoring: (i) If the 
results of the initial biological monitoring tests show the employee's 
CdU level to be at or below 3 [micro]g/g Cr, [beta]2-M level 
to be at or below 300 [micro]g/g Cr and CdB level to be at or below 5 
[micro]g/lwb, then:
    (A) For currently exposed employees, who are subject to medical 
surveillance under paragraph (l)(1)(i)(A) of this section, the employer 
shall provide the minimum level of periodic medical surveillance in 
accordance with the requirements in paragraph (l)(4)(i) of this section; 
and
    (B) For previously exposed employees, who are subject to medical 
surveillance under paragraph (l)(1)(i)(B) of this section, the employer 
shall provide biological monitoring for CdU, [beta]2-M, and 
CdB one year after the initial biological monitoring and then the 
employer shall comply with the requirements of paragraph (l)(4)(v) of 
this section.
    (ii) For all employees who are subject to medical surveillance under 
paragraph (l)(1)(i) of this section, if the results of the initial 
biological monitoring tests show the level of CdU to exceed 3 [micro]g/g 
Cr, the level of [beta]2-M to exceed 300 [micro]g/g Cr, or 
the level of CdB to exceed 5 [micro]g/lwb, the employer shall:
    (A) Within two weeks after receipt of biological monitoring results, 
reassess the employee's occupational exposure to cadmium as follows:
    (1) Reassess the employee's work practices and personal hygiene;
    (2) Reevaluate the employee's respirator use, if any, and the 
respirator program;
    (3) Review the hygiene facilities;
    (4) Reevaluate the maintenance and effectiveness of the relevant 
engineering controls;
    (5) Assess the employee's smoking history and status;
    (B) Within 30 days after the exposure reassessment, specified in 
paragraph (l)(3)(ii)(A) of this section, take reasonable steps to 
correct any deficiencies found in the reassessment that may be 
responsible for the employee's excess exposure to cadmium; and,
    (C) Within 90 days after receipt of biological monitoring results, 
provide a full medical examination to the employee in accordance with 
the requirements of paragraph (l)(4)(ii) of this section. After 
completing the medical examination, the examining physician shall 
determine in a written medical opinion whether to medically remove the 
employee. If the physician determines that medical removal is not 
necessary, then until the employee's CdU level falls to or below 3 
[micro]g/g Cr, [beta]2-M level falls to or below 300 
[micro]g/g Cr and CdB level falls to or below 5 [micro]g/lwb, the 
employer shall:
    (1) Provide biological monitoring in accordance with paragraph 
(l)(2)(ii)(B) of this section on a semiannual basis; and
    (2) Provide annual medical examinations in accordance with paragraph 
(l)(4)(ii) of this section.
    (iii) For all employees who are subject to medical surveillance 
under paragraph (l)(1)(i) of this section, if the results of the initial 
biological monitoring tests show the level of CdU to be in excess of 15 
[micro]g/g Cr, or the level of CdB to be in excess of 15 [micro]g/lwb, 
or the level of [beta]2-M to be in excess of 1,500 [micro]g/g 
Cr, the employer shall comply with the requirements of paragraphs 
(l)(3)(ii)(A)-(B) of this section. Within 90 days after receipt of 
biological monitoring results, the employer shall provide a full medical 
examination to the employee in accordance with the requirements of 
paragraph (l)(4)(ii) of this section. After completing the medical 
examination, the examining physician shall determine in a written 
medical opinion whether to medically remove the employee. However, if 
the initial biological monitoring results and the biological monitoring 
results obtained during the medical examination both show that: CdU 
exceeds 15 [micro]g/g Cr; or CdB exceeds 15 [micro]g/lwb; or 
[beta]2-M exceeds 1500 [micro]g/g Cr, and in addition CdU 
exceeds 3 [micro]g/g Cr or CdB exceeds 5 [micro]g/liter of whole blood, 
then the physician shall medically remove the employee from exposure to 
cadmium at or above the action level. If the second set of biological 
monitoring results obtained during the medical examination does not show 
that a mandatory removal trigger level has been exceeded, then the 
employee is not required to be removed by the mandatory provisions of 
this paragraph. If the employee is

[[Page 150]]

not required to be removed by the mandatory provisions of this paragraph 
or by the physician's determination, then until the employee's CdU level 
falls to or below 3 [micro]g/g Cr, [beta]2-M level falls to 
or below 300 [micro]g/g Cr and CdB level falls to or below 5 [micro]g/
lwb, the employer shall:
    (A) Periodically reassess the employee's occupational exposure to 
cadmium;
    (B) Provide biological monitoring in accordance with paragraph 
(l)(2)(ii)(B) of this section on a quarterly basis; and
    (C) Provide semiannual medical examinations in accordance with 
paragraph (l)(4)(ii) of this section.
    (iv) For all employees to whom medical surveillance is provided, 
beginning on January 1, 1999, and in lieu of paragraphs (l)(3)(i)-(iii) 
of this section:
    (A) If the results of the initial biological monitoring tests show 
the employee's CdU level to be at or below 3 [micro]g/g Cr, 
[beta]2-M level to be at or below 300 [micro]g/g Cr and CdB 
level to be at or below 5 [micro]g/lwb, then for currently exposed 
employees, the employer shall comply with the requirements of paragraph 
(l)(3)(i)(A) of this section, and for previously exposed employees, the 
employer shall comply with the requirements of paragraph (l)(3)(i)(B) of 
this section;
    (B) If the results of the initial biological monitoring tests show 
the level of CdU to exceed 3 [micro]g/g Cr, the level of 
[beta]2-M to exceed 300 [micro]g/g Cr, or the level of CdB to 
exceed 5 [micro]g/lwb, the employer shall comply with the requirements 
of paragraphs (l)(3)(ii)(A)-(C) of this section; and,
    (C) If the results of the initial biological monitoring tests show 
the level of CdU to be in excess of 7 [micro]g/g Cr, or the level of CdB 
to be in excess of 10 [micro]g/lwb, or the level of [beta]2-M 
to be in excess of 750 [micro]g/g Cr, the employer shall: Comply with 
the requirements of paragraphs (l)(3)(ii)(A)-(B) of this section; and, 
within 90 days after receipt of biological monitoring results, provide a 
full medical examination to the employee in accordance with the 
requirements of paragraph (l)(4)(ii) of this section. After completing 
the medical examination, the examining physician shall determine in a 
written medical opinion whether to medically remove the employee. 
However, if the initial biological monitoring results and the biological 
monitoring results obtained during the medical examination both show 
that: CdU exceeds 7 [micro]g/g Cr; or CdB exceeds 10 [micro]g/lwb; or 
[beta]2-M exceeds 750 [micro]g/g Cr, and in addition CdU 
exceeds 3 [micro]g/g Cr or CdB exceeds 5 [micro]g/liter of whole blood, 
then the physician shall medically remove the employee from exposure to 
cadmium at or above the action level. If the second set of biological 
monitoring results obtained during the medical examination does not show 
that a mandatory removal trigger level has been exceeded, then the 
employee is not required to be removed by the mandatory provisions of 
this paragraph. If the employee is not required to be removed by the 
mandatory provisions of this paragraph or by the physician's 
determination, then until the employee's CdU level falls to or below 3 
[micro]g/g Cr, [beta]2-M level falls to or below 300 
[micro]g/g Cr and CdB level falls to or below 5 [micro]g/lwb, the 
employer shall: periodically reassess the employee's occupational 
exposure to cadmium; provide biological monitoring in accordance with 
paragraph (l)(2)(ii)(B) of this section on a quarterly basis; and 
provide semiannual medical examinations in accordance with paragraph 
(l)(4)(ii) of this section.
    (4) Periodic medical surveillance. (i) For each employee who is 
covered under paragraph (l)(1)(i)(A) of this section, the employer shall 
provide at least the minimum level of periodic medical surveillance, 
which consists of periodic medical examinations and periodic biological 
monitoring. A periodic medical examination shall be provided within one 
year after the initial examination required by paragraph (l)(2) of this 
section and thereafter at least biennially. Biological sampling shall be 
provided at least annually, either as part of a periodic medical 
examination or separately as periodic biological monitoring.
    (ii) The periodic medical examination shall include:
    (A) A detailed medical and work history, or update thereof, with 
emphasis on: Past, present and anticipated future exposure to cadmium; 
smoking history and current status; reproductive history; current use of 
medications with potential nephrotoxic side-

[[Page 151]]

effects; any history of renal, cardiovascular, respiratory, 
hematopoietic, and/or musculo-skeletal system dysfunction; and as part 
of the medical and work history, for employees who wear respirators, 
questions 3-11 and 25-32 in Appendix D to this section;
    (B) A complete physical examination with emphasis on: Blood 
pressure, the respiratory system, and the urinary system;
    (C) A 14 inch by 17 inch, or a reasonably standard sized posterior-
anterior chest X-ray (after the initial X-ray, the frequency of chest X-
rays is to be determined by the examining physician);
    (D) Pulmonary function tests, including forced vital capacity (FVC) 
and forced expiratory volume at 1 second (FEV1);
    (E) Biological monitoring, as required in paragraph (l)(2)(ii)(B) of 
this section;
    (F) Blood analysis, in addition to the analysis required under 
paragraph (l)(2)(ii)(B) of this section, including blood urea nitrogen, 
complete blood count, and serum creatinine;
    (G) Urinalysis, in addition to the analysis required under paragraph 
(l)(2)(ii)(B) of this section, including the determination of albumin, 
glucose, and total and low molecular weight proteins;
    (H) For males over 40 years old, prostate palpation, or other at 
least as effective diagnostic test(s); and
    (I) Any additional tests deemed appropriate by the examining 
physician.
    (iii) Periodic biological monitoring shall be provided in accordance 
with paragraph (l)(2)(ii)(B) of this section.
    (iv) If the results of periodic biological monitoring or the results 
of biological monitoring performed as part of the periodic medical 
examination show the level of the employee's CdU, [beta]2-M, 
or CdB to be in excess of the levels specified in paragraphs (l)(3)(ii) 
or (iii); or, beginning on January 1, 1999, in excess of the levels 
specified in paragraphs (l)(3)(ii) or (iv) of this section, the employer 
shall take the appropriate actions specified in paragraphs (l)(3)(ii)-
(iv) of this section.
    (v) For previously exposed employees under paragraph (l)(1)(i)(B) of 
this section:
    (A) If the employee's levels of CdU did not exceed 3 [micro]g/g Cr, 
CdB did not exceed 5 [micro]g/lwb, and [beta]2-M did not 
exceed 300 [micro]g/g Cr in the initial biological monitoring tests, and 
if the results of the followup biological monitoring required by 
paragraph (l)(3)(i)(B) of this section one year after the initial 
examination confirm the previous results, the employer may discontinue 
all periodic medical surveillance for that employee.
    (B) If the initial biological monitoring results for CdU, CdB, or 
[beta]2-M were in excess of the levels specified in paragraph 
(l)(3)(i) of this section, but subsequent biological monitoring results 
required by paragraph (l)(3)(ii)-(iv) of this section show that the 
employee's CdU levels no longer exceed 3 [micro]g/g Cr, CdB levels no 
longer exceed 5 [micro]g/lwb, and [beta]2-M levels no longer 
exceed 300 [micro]g/g Cr, the employer shall provide biological 
monitoring for CdU, CdB, and [beta]2-M one year after these 
most recent biological monitoring results. If the results of the 
followup biological monitoring, specified in this paragraph, confirm the 
previous results, the employer may discontinue all periodic medical 
surveillance for that employee.
    (C) However, if the results of the follow-up tests specified in 
paragraph (l)(4)(v)(A) or (B) of this section indicate that the level of 
the employee's CdU, [beta]2-M, or CdB exceeds these same 
levels, the employer is required to provide annual medical examinations 
in accordance with the provisions of paragraph (l)(4)(ii) of this 
section until the results of biological monitoring are consistently 
below these levels or the examining physician determines in a written 
medical opinion that further medical surveillance is not required to 
protect the employee's health.
    (vi) A routine, biennial medical examination is not required to be 
provided in accordance with paragraphs (l)(3)(i) and (l)(4) of this 
section if adequate medical records show that the employee has been 
examined in accordance with the requirements of paragraph (l)(4)(ii) of 
this section within the past 12 months. In that case, such

[[Page 152]]

records shall be maintained by the employer as part of the employee's 
medical record, and the next routine, periodic medical examination shall 
be made available to the employee within two years of the previous 
examination.
    (5) Actions triggered by medical examinations. (i) If the results of 
a medical examination carried out in accordance with this section 
indicate any laboratory or clinical finding consistent with cadmium 
toxicity that does not require employer action under paragraph (l)(2), 
(3) or (4) of this section, the employer, within 30 days, shall reassess 
the employee's occupational exposure to cadmium and take the following 
corrective action until the physician determines they are no longer 
necessary:
    (A) Periodically reassess: The employee's work practices and 
personal hygiene; the employee's respirator use, if any; the employee's 
smoking history and status; the respiratory protection program; the 
hygiene facilities; and the maintenance and effectiveness of the 
relevant engineering controls;
    (B) Within 30 days after the reassessment, take all reasonable steps 
to correct the deficiencies found in the reassessment that may be 
responsible for the employee's excess exposure to cadmium;
    (C) Provide semiannual medical reexaminations to evaluate the 
abnormal clinical sign(s) of cadmium toxicity until the results are 
normal or the employee is medically removed; and
    (D) Where the results of tests for total proteins in urine are 
abnormal, provide a more detailed medical evaluation of the toxic 
effects of cadmium on the employee's renal system.
    (6) Examination for respirator use. (i) To determine an employee's 
fitness for respirator use, the employer shall provide a medical 
examination that includes the elements specified in paragraph 
(l)(6)(i)(A)-(D) of this section. This examination shall be provided 
prior to the employee's being assigned to a job that requires the use of 
a respirator or no later than 90 days after this section goes into 
effect, whichever date is later, to any employee without a medical 
examination within the preceding 12 months that satisfies the 
requirements of this paragraph.
    (A) A detailed medical and work history, or update thereof, with 
emphasis on: Past exposure to cadmium; smoking history and current 
status; any history of renal, cardiovascular, respiratory, 
hematopoietic, and/or musculoskeletal system dysfunction; a description 
of the job for which the respirator is required; and questions 3-11 and 
25-32 in appendix D to this section;
    (B) A blood pressure test;
    (C) Biological monitoring of the employee's levels of CdU, CdB and 
[beta]2-M in accordance with the requirements of paragraph 
(l)(2)(ii)(B) of this section, unless such results already have been 
obtained within the previous 12 months; and
    (D) Any other test or procedure that the examining physician deems 
appropriate.
    (ii) After reviewing all the information obtained from the medical 
examination required in paragraph (l)(6)(i) of this section, the 
physician shall determine whether the employee is fit to wear a 
respirator.
    (iii) Whenever an employee has exhibited difficulty in breathing 
during a respirator fit test or during use of a respirator, the 
employer, as soon as possible, shall provide the employee with a 
periodic medical examination in accordance with paragraph (l)(4)(ii) of 
this section to determine the employee's fitness to wear a respirator.
    (iv) Where the results of the examination required under paragraph 
(l)(6)(i), (ii), or (iii) of this section are abnormal, medical 
limitation or prohibition of respirator use shall be considered. If the 
employee is allowed to wear a respirator, the employee's ability to 
continue to do so shall be periodically evaluated by a physician.
    (7) Emergency examinations. (i) In addition to the medical 
surveillance required in paragraphs (l)(2)-(6) of this section, the 
employer shall provide a medical examination as soon as possible to any 
employee who may have been acutely exposed to cadmium because of an 
emergency.
    (ii) The examination shall include the requirements of paragraph 
(l)(4)(ii) of this section, with emphasis on the respiratory system, 
other organ systems considered appropriate by the examining physician, 
and symptoms of

[[Page 153]]

acute overexposure, as identified in paragraphs II (B)(1)-(2) and IV of 
appendix A to this section.
    (8) Termination of employment examination. (i) At termination of 
employment, the employer shall provide a medical examination in 
accordance with paragraph (l)(4)(ii) of this section, including a chest 
X-ray, to any employee to whom at any prior time the employer was 
required to provide medical surveillance under paragraphs (l)(1)(i) or 
(l)(7) of this section. However, if the last examination satisfied the 
requirements of paragraph (l)(4)(ii) of this section and was less than 
six months prior to the date of termination, no further examination is 
required unless otherwise specified in paragraphs (l)(3) or (l)(5) of 
this section;
    (ii) However, for employees covered by paragraph (l)(1)(i)(B) of 
this section, if the employer has discontinued all periodic medical 
surveillance under paragraph (l)(4)(v) of this section, no termination 
of employment medical examination is required.
    (9) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this standard and appendices;
    (ii) A description of the affected employee's former, current, and 
anticipated duties as they relate to the employee's occupational 
exposure to cadmium;
    (iii) The employee's former, current, and anticipated future levels 
of occupational exposure to cadmium;
    (iv) A description of any personal protective equipment, including 
respirators, used or to be used by the employee, including when and for 
how long the employee has used that equipment; and
    (v) relevant results of previous biological monitoring and medical 
examinations.
    (10) Physician's written medical opinion. (i) The employer shall 
promptly obtain a written, medical opinion from the examining physician 
for each medical examination performed on each employee. This written 
opinion shall contain:
    (A) The physician's diagnosis for the employee;
    (B) The physician's opinion as to whether the employee has any 
detected medical condition(s) that would place the employee at increased 
risk of material impairment to health from further exposure to cadmium, 
including any indications of potential cadmium toxicity;
    (C) The results of any biological or other testing or related 
evaluations that directly assess the employee's absorption of cadmium;
    (D) Any recommended removal from, or limitation on the activities or 
duties of the employee or on the employee's use of personal protective 
equipment, such as respirators;
    (E) A statement that the physician has clearly and carefully 
explained to the employee the results of the medical examination, 
including all biological monitoring results and any medical conditions 
related to cadmium exposure that require further evaluation or 
treatment, and any limitation on the employee's diet or use of 
medications.
    (ii) The employer promptly shall obtain a copy of the results of any 
biological monitoring provided by an employer to an employee 
independently of a medical examination under paragraphs (l)(2) and 
(l)(4) of this section, and, in lieu of a written medical opinion, an 
explanation sheet explaining those results.
    (iii) The employer shall instruct the physician not to reveal orally 
or in the written medical opinion given to the employer specific 
findings or diagnoses unrelated to occupational exposure to cadmium.
    (11) Medical Removal Protection (MRP)--(i) General. (A) The employer 
shall temporarily remove an employee from work where there is excess 
exposure to cadmium on each occasion that medical removal is required 
under paragraph (l)(3), (l)(4), or (l)(6) of this section and on each 
occasion that a physician determines in a written medical opinion that 
the employee should be removed from such exposure. The physician's 
determination may be based on biological monitoring results, inability 
to wear a respirator, evidence of illness, other signs or symptoms of

[[Page 154]]

cadmium-related dysfunction or disease, or any other reason deemed 
medically sufficient by the physician.
    (B) The employer shall medically remove an employee in accordance 
with paragraph (l)(11) of this section regardless of whether at the time 
of removal a job is available into which the removed employee may be 
transferred.
    (C) Whenever an employee is medically removed under paragraph 
(l)(11) of this section, the employer shall transfer the removed 
employee to a job where the exposure to cadmium is within the 
permissible levels specified in that paragraph as soon as one becomes 
available.
    (D) For any employee who is medically removed under the provisions 
of paragraph (l)(11)(i) of this section, the employer shall provide 
follow-up biological monitoring in accordance with (l)(2)(ii)(B) of this 
section at least every three months and follow-up medical examinations 
semi-annually at least every six months until in a written medical 
opinion the examining physician determines that either the employee may 
be returned to his/her former job status as specified under paragraph 
(l)(11)(iv)-(v) of this section or the employee must be permanently 
removed from excess cadmium exposure.
    (E) The employer may not return an employee who has been medically 
removed for any reason to his/her former job status until a physician 
determines in a written medical opinion that continued medical removal 
is no longer necessary to protect the employee's health.
    (ii) Where an employee is found unfit to wear a respirator under 
paragraph (l)(6)(ii) of this section, the employer shall remove the 
employee from work where exposure to cadmium is above the PEL.
    (iii) Where removal is based on any reason other than the employee's 
inability to wear a respirator, the employer shall remove the employee 
from work where exposure to cadmium is at or above the action level.
    (iv) Except as specified in paragraph (l)(11)(v) of this section, no 
employee who was removed because his/her level of CdU, CdB and/or 
[beta]2-M exceeded the medical removal trigger levels in 
paragraph (l)(3) or (l)(4) of this section may be returned to work with 
exposure to cadmium at or above the action level until the employee's 
levels of CdU fall to or below 3 [micro]g/g Cr, CdB falls to or below 5 
[micro]g/lwb, and [beta]2-M falls to or below 300 [micro]g/g 
Cr.
    (v) However, when in the examining physician's opinion continued 
exposure to cadmium will not pose an increased risk to the employee's 
health and there are special circumstances that make continued medical 
removal an inappropriate remedy, the physician shall fully discuss these 
matters with the employee, and then in a written determination may 
return a worker to his/her former job status despite what would 
otherwise be unacceptably high biological monitoring results. 
Thereafter, the returned employee shall continue to be provided with 
medical surveillance as if he/she were still on medical removal until 
the employee's levels of CdU fall to or below 3 [micro]g/g Cr, CdB falls 
to or below 5 [micro]g/lwb, and [beta]2-M falls to or below 
300 [micro]g/g Cr.
    (vi) Where an employer, although not required by paragraph 
(l)(11)(i)-(iii) of this section to do so, removes an employee from 
exposure to cadmium or otherwise places limitations on an employee due 
to the effects of cadmium exposure on the employee's medical condition, 
the employer shall provide the same medical removal protection benefits 
to that employee under paragraph (l)(12) of this section as would have 
been provided had the removal been required under paragraph (l)(11)(i)-
(iii) of this section.
    (12) Medical Removal Protection Benefits (MRPB). (i) The employer 
shall provide MRPB for up to a maximum of 18 months to an employee each 
time and while the employee is temporarily medically removed under 
paragraph (l)(11) of this section.
    (ii) For purposes of this section, the requirement that the employer 
provide MRPB means that the employer shall maintain the total normal 
earnings, seniority, and all other employee rights and benefits of the 
removed employee, including the employee's right to his/her former job 
status, as if the employee had not been removed from the employee's job 
or otherwise medically limited.

[[Page 155]]

    (iii) Where, after 18 months on medical removal because of elevated 
biological monitoring results, the employee's monitoring results have 
not declined to a low enough level to permit the employee to be returned 
to his/her former job status:
    (A) The employer shall make available to the employee a medical 
examination pursuant to this section in order to obtain a final medical 
determination as to whether the employee may be returned to his/her 
former job status or must be permanently removed from excess cadmium 
exposure; and
    (B) The employer shall assure that the final medical determination 
indicates whether the employee may be returned to his/her former job 
status and what steps, if any, should be taken to protect the employee's 
health.
    (iv) The employer may condition the provision of MRPB upon the 
employee's participation in medical surveillance provided in accordance 
with this section.
    (13) Multiple physician review. (i) If the employer selects the 
initial physician to conduct any medical examination or consultation 
provided to an employee under this section, the employee may designate a 
second physician to:
    (A) Review any findings, determinations, or recommendations of the 
initial physician; and
    (B) Conduct such examinations, consultations, and laboratory tests 
as the second physician deems necessary to facilitate this review.
    (ii) The employer shall promptly notify an employee of the right to 
seek a second medical opinion after each occasion that an initial 
physician provided by the employer conducts a medical examination or 
consultation pursuant to this section. The employer may condition its 
participation in, and payment for, multiple physician review upon the 
employee doing the following within fifteen (15) days after receipt of 
this notice, or receipt of the initial physician's written opinion, 
whichever is later:
    (A) Informing the employer that he or she intends to seek a medical 
opinion; and
    (B) Initiating steps to make an appointment with a second physician.
    (iii) If the findings, determinations, or recommendations of the 
second physician differ from those of the initial physician, then the 
employer and the employee shall assure that efforts are made for the two 
physicians to resolve any disagreement.
    (iv) If the two physicians have been unable to quickly resolve their 
disagreement, then the employer and the employee, through their 
respective physicians, shall designate a third physician to:
    (A) Review any findings, determinations, or recommendations of the 
other two physicians; and
    (B) Conduct such examinations, consultations, laboratory tests, and 
discussions with the other two physicians as the third physician deems 
necessary to resolve the disagreement among them.
    (v) The employer shall act consistently with the findings, 
determinations, and recommendations of the third physician, unless the 
employer and the employee reach an agreement that is consistent with the 
recommendations of at least one of the other two physicians.
    (14) Alternate physician determination. The employer and an employee 
or designated employee representative may agree upon the use of any 
alternate form of physician determination in lieu of the multiple 
physician review provided by paragraph (l)(13) of this section, so long 
as the alternative is expeditious and at least as protective of the 
employee.
    (15) Information the employer must provide the employee. (i) The 
employer shall provide a copy of the physician's written medical opinion 
to the examined employee within two weeks after receipt thereof.
    (ii) The employer shall provide the employee with a copy of the 
employee's biological monitoring results and an explanation sheet 
explaining the results within two weeks after receipt thereof.
    (iii) Within 30 days after a request by an employee, the employer 
shall provide the employee with the information the employer is required 
to provide the examining physician under paragraph (l)(9) of this 
section.

[[Page 156]]

    (16) Reporting. In addition to other medical events that are 
required to be reported on the OSHA Form No. 200, the employer shall 
report any abnormal condition or disorder caused by occupational 
exposure to cadmium associated with employment as specified in Chapter 
(V)(E) of the Reporting Guidelines for Occupational Injuries and 
Illnesses.
    (m) Communication of cadmium hazards to employees--(1) General. In 
communications concerning cadmium hazards, employers shall comply with 
the requirements of OSHA's Hazard Communication Standard, 29 CFR 
1910.1200, including but not limited to the requirements concerning 
warning signs and labels, material safety data sheets (MSDS), and 
employee information and training. In addition, employers shall comply 
with the following requirements:
    (2) Warning signs. (i) Warning signs shall be provided and displayed 
in regulated areas. In addition, warning signs shall be posted at all 
approaches to regulated areas so that an employee may read the signs and 
take necessary protective steps before entering the area.
    (ii) Warning signs required by paragraph (m)(2)(i) of this section 
shall bear the following information:

                                 DANGER

                                 CADMIUM

                              CANCER HAZARD

                    CAN CAUSE LUNG AND KIDNEY DISEASE

                        AUTHORIZED PERSONNEL ONLY

                    RESPIRATORS REQUIRED IN THIS AREA

    (iii) The employer shall assure that signs required by this 
paragraph are illuminated, cleaned, and maintained as necessary so that 
the legend is readily visible.
    (3) Warning labels. (i) Shipping and storage containers containing 
cadmium, cadmium compounds, or cadmium contaminated clothing, equipment, 
waste, scrap, or debris shall bear appropriate warning labels, as 
specified in paragraph (m)(3)(ii) of this section.
    (ii) The warning labels shall include at least the following 
information:

                                 DANGER

                            CONTAINS CADMIUM

                              CANCER HAZARD

                           AVOID CREATING DUST

                    CAN CAUSE LUNG AND KIDNEY DISEASE

    (iii) Where feasible, installed cadmium products shall have a 
visible label or other indication that cadmium is present.
    (4) Employee information and training. (i) The employer shall train 
each employee who is potentially exposed to cadmium in accordance with 
the requirements of this section. The employer shall institute a 
training program, ensure employee participation in the program, and 
maintain a record of the contents of such program.
    (ii) Training shall be provided prior to or at the time of initial 
assignment to a job involving potential exposure to cadmium and at least 
annually thereafter.
    (iii) The employer shall make the training program understandable to 
the employee and shall assure that each employee is informed of the 
following:
    (A) The health hazards associated with cadmium exposure, with 
special attention to the information incorporated in appendix A to this 
section;
    (B) The quantity, location, manner of use, release, and storage of 
cadmium in the workplace and the specific nature of operations that 
could result in exposure to cadmium, especially exposures above the PEL;
    (C) The engineering controls and work practices associated with the 
employee's job assignment;
    (D) The measures employees can take to protect themselves from 
exposure to cadmium, including modification of such habits as smoking 
and personal hygiene, and specific procedures the employer has 
implemented to protect employees from exposure to cadmium such as 
appropriate work practices, emergency procedures, and the provision of 
personal protective equipment;
    (E) The purpose, proper selection, fitting, proper use, and 
limitations of respirators and protective clothing;
    (F) The purpose and a description of the medical surveillance 
program required by paragraph (l) of this section;
    (G) The contents of this section and its appendices; and

[[Page 157]]

    (H) The employee's rights of access to records under Sec. 
1910.1020(e) and (g).
    (iv) Additional access to information and training program and 
materials.
    (A) The employer shall make a copy of this section and its 
appendices readily available without cost to all affected employees and 
shall provide a copy if requested.
    (B) The employer shall provide to the Assistant Secretary or the 
Director, upon request, all materials relating to the employee 
information and the training program.
    (n) Recordkeeping--(1) Exposure monitoring. (i) The employer shall 
establish and keep an accurate record of all air monitoring for cadmium 
in the workplace.
    (ii) This record shall include at least the following information:
    (A) The monitoring date, duration, and results in terms of an 8-hour 
TWA of each sample taken;
    (B) The name, social security number, and job classification of the 
employees monitored and of all other employees whose exposures the 
monitoring is intended to represent;
    (C) A description of the sampling and analytical methods used and 
evidence of their accuracy;
    (D) The type of respiratory protective device, if any, worn by the 
monitored employee;
    (E) A notation of any other conditions that might have affected the 
monitoring results.
    (iii) The employer shall maintain this record for at least thirty 
(30) years, in accordance with 29 CFR 1910.1020.
    (2) Objective data for exemption from requirement for initial 
monitoring. (i) For purposes of this section, objective data are 
information demonstrating that a particular product or material 
containing cadmium or a specific process, operation, or activity 
involving cadmium cannot release dust or fumes in concentrations at or 
above the action level even under the worst-case release conditions. 
Objective data can be obtained from an industry-wide study or from 
laboratory product test results from manufacturers of cadmium-containing 
products or materials. The data the employer uses from an industry-wide 
survey must be obtained under workplace conditions closely resembling 
the processes, types of material, control methods, work practices and 
environmental conditions in the employer's current operations.
    (ii) The employer shall establish and maintain a record of the 
objective data for at least 30 years.
    (3) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee covered by medical 
surveillance under paragraph (l)(1)(i) of this section.
    (ii) The record shall include at least the following information 
about the employee:
    (A) Name, social security number, and description of the duties;
    (B) A copy of the physician's written opinions and an explanation 
sheet for biological monitoring results;
    (C) A copy of the medical history, and the results of any physical 
examination and all test results that are required to be provided by 
this section, including biological tests, X-rays, pulmonary function 
tests, etc., or that have been obtained to further evaluate any 
condition that might be related to cadmium exposure;
    (D) The employee's medical symptoms that might be related to 
exposure to cadmium; and
    (E) A copy of the information provided to the physician as required 
by paragraph (l)(9)(ii)-(v) of this section.
    (iii) The employer shall assure that this record is maintained for 
the duration of employment plus thirty (30) years, in accordance with 29 
CFR 1910.1020.
    (4) Training. The employer shall certify that employees have been 
trained by preparing a certification record which includes the identity 
of the person trained, the signature of the employer or the person who 
conducted the training, and the date the training was completed. The 
certification records shall be prepared at the completion of training 
and shall be maintained on file for one (1) year beyond the date of 
training of that employee.
    (5) Availability. (i) Except as otherwise provided for in this 
section, access to all records required to be maintained by paragraphs 
(n)(1)-(4) of this section shall be in accordance with the provisions of 
29 CFR 1910.1020.

[[Page 158]]

    (ii) Within 15 days after a request, the employer shall make an 
employee's medical records required to be kept by paragraph (n)(3) of 
this section available for examination and copying to the subject 
employee, to designated representatives, to anyone having the specific 
written consent of the subject employee, and after the employee's death 
or incapacitation, to the employee's family members.
    (6) Transfer of records. Whenever an employer ceases to do business 
and there is no successor employer to receive and retain records for the 
prescribed period or the employer intends to dispose of any records 
required to be preserved for at least 30 years, the employer shall 
comply with the requirements concerning transfer of records set forth in 
29 CFR 1910.1020 (h).
    (o) Observation of monitoring--(1) Employee observation. The 
employer shall provide affected employees or their designated 
representatives an opportunity to observe any monitoring of employee 
exposure to cadmium.
    (2) Observation procedures. When observation of monitoring requires 
entry into an area where the use of protective clothing or equipment is 
required, the employer shall provide the observer with that clothing and 
equipment and shall assure that the observer uses such clothing and 
equipment and complies with all other applicable safety and health 
procedures.
    (p) Dates--(1) Effective date. This section shall become effective 
December 14, 1992.
    (2) Start-up dates. All obligations of this section commence on the 
effective date except as follows:
    (i) Exposure monitoring. Except for small businesses (nineteen (19) 
or fewer employees), initial monitoring required by paragraph (d)(2) of 
this section shall be completed as soon as possible and in any event no 
later than 60 days after the effective date of this standard. For small 
businesses, initial monitoring required by paragraph (d)(2) of this 
section shall be completed as soon as possible and in any event no later 
than 120 days after the effective date of this standard.
    (ii) Regulated areas. Except for small business, defined under 
paragraph (p)(2)(i) of this section, regulated areas required to be 
established by paragraph (e) of this section shall be set up as soon as 
possible after the results of exposure monitoring are known and in any 
event no later than 90 days after the effective date of this section. 
For small businesses, regulated areas required to be established by 
paragraph (e) of this section shall be set up as soon as possible after 
the results of exposure monitoring are known and in any event no later 
than 150 days after the effective date of this section.
    (iii) Respiratory protection. Except for small businesses, defined 
under paragraph (p)(2)(i) of this section, respiratory protection 
required by paragraph (g) of this section shall be provided as soon as 
possible and in any event no later than 90 days after the effective date 
of this section. For small businesses, respiratory protection required 
by paragraph (g) of this section shall be provided as soon as possible 
and in any event no later than 150 days after the effective date of this 
section.
    (iv) Compliance program. Written compliance programs required by 
paragraph (f)(2) of this section shall be completed and available for 
inspection and copying as soon as possible and in any event no later 
than 1 year after the effective date of this section.
    (v) Methods of compliance. The engineering controls required by 
paragraph (f)(1) of this section shall be implemented as soon as 
possible and in any event no later than two (2) years after the 
effective date of this section. Work practice controls shall be 
implemented as soon as possible. Work practice controls that are 
directly related to engineering controls to be implemented in accordance 
with the compliance plan shall be implemented as soon as possible after 
such engineering controls are implemented.
    (vi) Hygiene and lunchroom facilities. (A) Handwashing facilities, 
permanent or temporary, shall be provided in accordance with 29 CFR 
1910.141 (d)(1) and (2) as soon as possible and in any event no later 
than 60 days after the effective date of this section.
    (B) Change rooms, showers, and lunchroom facilities shall be 
completed as soon as possible and in any event no later than 1 year 
after the effective date of this section.

[[Page 159]]

    (vii) Employee information and training. Except for small 
businesses, defined under paragraph (p)(2)(i) of this section, employee 
information and training required by paragraph (m)(4) of this section 
shall be provided as soon as possible and in any event no later than 90 
days after the effective date of this standard. For small businesses, 
employee information and training required by paragraph (m)(4) of this 
standard shall be provided as soon as possible and in any event no later 
than 180 days after the effective date of this standard.
    (viii) Medical surveillance. Except for small businesses, defined 
under paragraph (p)(2)(i) of this section, initial medical examinations 
required by paragraph (l) of this section shall be provided as soon as 
possible and in any event no later than 90 days after the effective date 
of this standard. For small businesses, initial medical examinations 
required by paragraph (l) of this section shall be provided as soon as 
possible and in any event no later than 180 days after the effective 
date of this standard.
    (q) Appendices. Except where portions of appendices A, B, D, E, and 
F to this section are expressly incorporated in requirements of this 
section, these appendices are purely informational and are not intended 
to create any additional obligations not otherwise imposed or to detract 
from any existing obligations.

       Appendix A to Sec. 1910.1027--Substance Safety Data Sheet

                                 Cadmium

                       I. Substance Identification

    A. Substance: Cadmium.
    B. 8-Hour, Time-weighted-average, Permissible Exposure Limit (TWA 
PEL):
    1. TWA PEL: Five micrograms of cadmium per cubic meter of air 5 
[micro]g/m\3\, time-weighted average (TWA) for an 8-hour workday.
    C. Appearance: Cadmium metal--soft, blue-white, malleable, lustrous 
metal or grayish-white powder. Some cadmium compounds may also appear as 
a brown, yellow, or red powdery substance.

                         II. Health Hazard Data

    A. Routes of Exposure. Cadmium can cause local skin or eye 
irritation. Cadmium can affect your health if you inhale it or if you 
swallow it.
    B. Effects of Overexposure.
    1. Short-term (acute) exposure: Cadmium is much more dangerous by 
inhalation than by ingestion. High exposures to cadmium that may be 
immediately dangerous to life or health occur in jobs where workers 
handle large quantities of cadmium dust or fume; heat cadmium-containing 
compounds or cadmium-coated surfaces; weld with cadmium solders or cut 
cadmium-containing materials such as bolts.
    2. Severe exposure may occur before symptoms appear. Early symptoms 
may include mild irritation of the upper respiratory tract, a sensation 
of constriction of the throat, a metallic taste and/or a cough. A period 
of 1-10 hours may precede the onset of rapidly progressing shortness of 
breath, chest pain, and flu-like symptoms with weakness, fever, 
headache, chills, sweating and muscular pain. Acute pulmonary edema 
usually develops within 24 hours and reaches a maximum by three days. If 
death from asphyxia does not occur, symptoms may resolve within a week.
    3. Long-term (chronic) exposure. Repeated or long-term exposure to 
cadmium, even at relatively low concentrations, may result in kidney 
damage and an increased risk of cancer of the lung and of the prostate.
    C. Emergency First Aid Procedures.
    1. Eye exposure: Direct contact may cause redness or pain. Wash eyes 
immediately with large amounts of water, lifting the upper and lower 
eyelids. Get medical attention immediately.
    2. Skin exposure: Direct contact may result in irritation. Remove 
contaminated clothing and shoes immediately. Wash affected area with 
soap or mild detergent and large amounts of water. Get medical attention 
immediately.
    3. Ingestion: Ingestion may result in vomiting, abdominal pain, 
nausea, diarrhea, headache and sore throat. Treatment for symptoms must 
be administered by medical personnel. Under no circumstances should the 
employer allow any person whom he retains, employs, supervises or 
controls to engage in therapeutic chelation. Such treatment is likely to 
translocate cadmium from pulmonary or other tissue to renal tissue. Get 
medical attention immediately.
    4. Inhalation: If large amounts of cadmium are inhaled, the exposed 
person must be moved to fresh air at once. If breathing has stopped, 
perform cardiopulmonary resuscitation. Administer oxygen if available. 
Keep the affected person warm and at rest. Get medical attention 
immediately.
    5. Rescue: Move the affected person from the hazardous exposure. If 
the exposed person has been overcome, attempt rescue only after 
notifying at least one other person of the emergency and putting into 
effect established emergency procedures. Do not become

[[Page 160]]

a casualty yourself. Understand your emergency rescue procedures and 
know the location of the emergency equipment before the need arises.

                        III. Employee Information

    A. Protective Clothing and Equipment.
    1. Respirators: You may be required to wear a respirator for non-
routine activities; in emergencies; while your employer is in the 
process of reducing cadmium exposures through engineering controls; and 
where engineering controls are not feasible. If respirators are worn in 
the future, they must have a joint Mine Safety and Health Administration 
(MSHA) and National Institute for Occupational Safety and Health (NIOSH) 
label of approval. Cadmium does not have a detectable odor except at 
levels well above the permissible exposure limits. If you can smell 
cadmium while wearing a respirator, proceed immediately to fresh air. If 
you experience difficulty breathing while wearing a respirator, tell 
your employer.
    2. Protective Clothing: You may be required to wear impermeable 
clothing, gloves, foot gear, a face shield, or other appropriate 
protective clothing to prevent skin contact with cadmium. Where 
protective clothing is required, your employer must provide clean 
garments to you as necessary to assure that the clothing protects you 
adequately. The employer must replace or repair protective clothing that 
has become torn or otherwise damaged.
    3. Eye Protection: You may be required to wear splash-proof or dust 
resistant goggles to prevent eye contact with cadmium.
    B. Employer Requirements.
    1. Medical: If you are exposed to cadmium at or above the action 
level, your employer is required to provide a medical examination, 
laboratory tests and a medical history according to the medical 
surveillance provisions under paragraph (1) of this standard. (See 
summary chart and tables in this appendix A.) These tests shall be 
provided without cost to you. In addition, if you are accidentally 
exposed to cadmium under conditions known or suspected to constitute 
toxic exposure to cadmium, your employer is required to make special 
tests available to you.
    2. Access to Records: All medical records are kept strictly 
confidential. You or your representative are entitled to see the records 
of measurements of your exposure to cadmium. Your medical examination 
records can be furnished to your personal physician or designated 
representative upon request by you to your employer.
    3. Observation of Monitoring: Your employer is required to perform 
measurements that are representative of your exposure to cadmium and you 
or your designated representative are entitled to observe the monitoring 
procedure. You are entitled to observe the steps taken in the 
measurement procedure, and to record the results obtained. When the 
monitoring procedure is taking place in an area where respirators or 
personal protective clothing and equipment are required to be worn, you 
or your representative must also be provided with, and must wear the 
protective clothing and equipment.
    C. Employee Requirements--You will not be able to smoke, eat, drink, 
chew gum or tobacco, or apply cosmetics while working with cadmium in 
regulated areas. You will also not be able to carry or store tobacco 
products, gum, food, drinks or cosmetics in regulated areas because 
these products easily become contaminated with cadmium from the 
workplace and can therefore create another source of unnecessary cadmium 
exposure.
    Some workers will have to change out of work clothes and shower at 
the end of the day, as part of their workday, in order to wash cadmium 
from skin and hair. Handwashing and cadmium-free eating facilities shall 
be provided by the employer and proper hygiene should always be 
performed before eating. It is also recommended that you do not smoke or 
use tobacco products, because among other things, they naturally contain 
cadmium. For further information, read the labeling on such products.

                        IV. Physician Information

    A. Introduction. The medical surveillance provisions of paragraph 
(1) generally are aimed at accomplishing three main interrelated 
purposes: First, identifying employees at higher risk of adverse health 
effects from excess, chronic exposure to cadmium; second, preventing 
cadmium-induced disease; and third, detecting and minimizing existing 
cadmium-induced disease. The core of medical surveillance in this 
standard is the early and periodic monitoring of the employee's 
biological indicators of: (a) Recent exposure to cadmium; (b) cadmium 
body burden; and (c) potential and actual kidney damage associated with 
exposure to cadmium.
    The main adverse health effects associated with cadmium overexposure 
are lung cancer and kidney dysfunction. It is not yet known how to 
adequately biologically monitor human beings to specifically prevent 
cadmium-induced lung cancer. By contrast, the kidney can be monitored to 
provide prevention and early detection of cadmium-induced kidney damage. 
Since, for non-carcinogenic effects, the kidney is considered the 
primary target organ of chronic exposure to cadmium, the medical 
surveillance provisions of this standard effectively focus on cadmium-
induced kidney disease. Within that focus, the aim, where possible, is 
to prevent the onset of such disease and, where necessary, to minimize 
such disease as may already exist. The by-products of successful 
prevention of kidney disease are anticipated to be

[[Page 161]]

the reduction and prevention of other cadmium-induced diseases.
    B. Health Effects. The major health effects associated with cadmium 
overexposure are described below.
    1. Kidney: The most prevalent non-malignant disease observed among 
workers chronically exposed to cadmium is kidney dysfunction. Initially, 
such dysfunction is manifested as proteinuria. The proteinuria 
associated with cadmium exposure is most commonly characterized by 
excretion of low-molecular weight proteins (15,000 to 40,000 MW) 
accompanied by loss of electrolytes, uric acid, calcium, amino acids, 
and phosphate. The compounds commonly excreted include: beta-2-
microglobulin ([beta]2-M), retinol binding protein (RBP), 
immunoglobulin light chains, and lysozyme. Excretion of low molecular 
weight proteins are characteristic of damage to the proximal tubules of 
the kidney (Iwao et al., 1980).
    It has also been observed that exposure to cadmium may lead to 
urinary excretion of high-molecular weight proteins such as albumin, 
immunoglobulin G, and glycoproteins (Ex. 29). Excretion of high-
molecular weight proteins is typically indicative of damage to the 
glomeruli of the kidney. Bernard et al., (1979) suggest that damage to 
the glomeruli and damage to the proximal tubules of the kidney may both 
be linked to cadmium exposure but they may occur independently of each 
other.
    Several studies indicate that the onset of low-molecular weight 
proteinuria is a sign of irreversible kidney damage (Friberg et al., 
1974; Roels et al., 1982; Piscator 1984; Elinder et al., 1985; Smith et 
al., 1986). Above specific levels of [beta]2-M associated 
with cadmium exposure it is unlikely that [beta]2-M levels 
return to normal even when cadmium exposure is eliminated by removal of 
the individual from the cadmium work environment (Friberg, Ex. 29, 
1990).
    Some studies indicate that such proteinuria may be progressive; 
levels of [beta]2-M observed in the urine increase with time 
even after cadmium exposure has ceased. See, for example, Elinder et 
al., 1985. Such observations, however, are not universal, and it has 
been suggested that studies in which proteinuria has not been observed 
to progress may not have tracked patients for a sufficiently long time 
interval (Jarup, Ex. 8-661).
    When cadmium exposure continues after the onset of proteinuria, 
chronic nephrotoxicity may occur (Friberg, Ex. 29). Uremia results from 
the inability of the glomerulus to adequately filter blood. This leads 
to severe disturbance of electrolyte concentrations and may lead to 
various clinical complications including kidney stones (L-140-50).
    After prolonged exposure to cadmium, glomerular proteinuria, 
glucosuria, aminoaciduria, phosphaturia, and hypercalciuria may develop 
(Exs. 8-86, 4-28, 14-18). Phosphate, calcium, glucose, and amino acids 
are essential to life, and under normal conditions, their excretion 
should be regulated by the kidney. Once low molecular weight proteinuria 
has developed, these elements dissipate from the human body. Loss of 
glomerular function may also occur, manifested by decreased glomerular 
filtration rate and increased serum creatinine. Severe cadmium-induced 
renal damage may eventually develop into chronic renal failure and 
uremia (Ex. 55).
    Studies in which animals are chronically exposed to cadmium confirm 
the renal effects observed in humans (Friberg et al., 1986). Animal 
studies also confirm problems with calcium metabolism and related 
skeletal effects which have been observed among humans exposed to 
cadmium in addition to the renal effects. Other effects commonly 
reported in chronic animal studies include anemia, changes in liver 
morphology, immunosuppression and hypertension. Some of these effects 
may be associated with co-factors. Hypertension, for example, appears to 
be associated with diet as well as cadmium exposure. Animals injected 
with cadmium have also shown testicular necrosis (Ex. 8-86B).

                          2. Biological Markers

    It is universally recognized that the best measures of cadmium 
exposures and its effects are measurements of cadmium in biological 
fluids, especially urine and blood. Of the two, CdU is conventionally 
used to determine body burden of cadmium in workers without kidney 
disease. CdB is conventionally used to monitor for recent exposure to 
cadmium. In addition, levels of CdU and CdB historically have been used 
to predict the percent of the population likely to develop kidney 
disease (Thun et al., Ex. L-140-50; WHO, Ex. 8-674; ACGIH, Exs. 8-667, 
140-50).
    The third biological parameter upon which OSHA relies for medical 
surveillance is Beta-2-microglobulin in urine ([beta]2-M), a 
low molecular weight protein. Excess [beta]2-M has been 
widely accepted by physicians and scientists as a reliable indicator of 
functional damage to the proximal tubule of the kidney (Exs. 8-447, 144-
3-C, 4-47, L-140-45, 19-43-A).
    Excess [beta]2-M is found when the proximal tubules can 
no longer reabsorb this protein in a normal manner. This failure of the 
proximal tubules is an early stage of a kind of kidney disease that 
commonly occurs among workers with excessive cadmium exposure. Used in 
conjunction with biological test results indicating abnormal levels of 
CdU and CdB, the finding of excess [beta]2-M can establish 
for an examining physician that any existing kidney disease is probably 
cadmium-related (Trs. 6/6/90, pp. 82-86, 122, 134). The upper limits of 
normal levels for cadmium in urine and

[[Page 162]]

cadmium in blood are 3 [micro]g Cd/gram creatinine in urine and 5 
[micro]gCd/liter whole blood, respectively. These levels were derived 
from broad-based population studies.
    Three issues confront the physicians in the use of 
[beta]2-M as a marker of kidney dysfunction and material 
impairment. First, there are a few other causes of elevated levels of 
[beta]2-M not related to cadmium exposures, some of which may 
be rather common diseases and some of which are serious diseases (e.g., 
myeloma or transient flu, Exs. 29 and 8-086). These can be medically 
evaluated as alternative causes (Friberg, Ex. 29). Also, there are other 
factors that can cause [beta]2-M to degrade so that low 
levels would result in workers with tubular dysfunction. For example, 
regarding the degradation of [beta]2-M, workers with acidic 
urine (pH<6) might have [beta]2-M levels that are within the 
``normal'' range when in fact kidney dysfunction has occurred (Ex. L-
140-1) and the low molecular weight proteins are degraded in acid urine. 
Thus, it is very important that the pH of urine be measured, that urine 
samples be buffered as necessary (See appendix F.), and that urine 
samples be handled correctly, i.e., measure the pH of freshly voided 
urine samples, then if necessary, buffer to pH6 (or above for 
shipping purposes), measure pH again and then, perhaps, freeze the 
sample for storage and shipping. (See also appendix F.) Second, there is 
debate over the pathological significance of proteinuria, however, most 
world experts believe that [beta]2-M levels greater than 300 
[micro]g/g Cr are abnormal (Elinder, Ex. 55, Friberg, Ex. 29). Such 
levels signify kidney dysfunction that constitutes material impairment 
of health. Finally, detection of [beta]2-M at low levels has 
often been considered difficult, however, many laboratories have the 
capability of detecting excess [beta]2-M using simple kits, 
such as the Phadebas Delphia test, that are accurate to levels of 100 
[micro]g [beta]2-M/g Cr U (Ex. L-140-1).
    Specific recommendations for ways to measure [beta]2-M 
and proper handling of urine samples to prevent degradation of 
[beta]2-M have been addressed by OSHA in appendix F, in the 
section on laboratory standardization. All biological samples must be 
analyzed in a laboratory that is proficient in the analysis of that 
particular analyte, under paragraph (l)(1)(iv). (See appendix F). 
Specifically, under paragraph (l)(1)(iv), the employer is to assure that 
the collecting and handling of biological samples of cadmium in urine 
(CdU), cadmium in blood (CdB), and beta-2 microglobulin in urine 
([beta]2-M) taken from employees is collected in a manner 
that assures reliability. The employer must also assure that analysis of 
biological samples of cadmium in urine (CdU), cadmium in blood (CdB), 
and beta-2 microglobulin in urine ([beta]2-M) taken from 
employees is performed in laboratories with demonstrated proficiency for 
that particular analyte. (See appendix F.)

                       3. Lung and Prostate Cancer

    The primary sites for cadmium-associated cancer appear to be the 
lung and the prostate (L-140-50). Evidence for an association between 
cancer and cadmium exposure derives from both epidemiological studies 
and animal experiments. Mortality from prostate cancer associated with 
cadmium is slightly elevated in several industrial cohorts, but the 
number of cases is small and there is not clear dose-response 
relationship. More substantive evidence exists for lung cancer.
    The major epidemiological study of lung cancer was conducted by Thun 
et al., (Ex. 4-68). Adequate data on cadmium exposures were available to 
allow evaluation of dose-response relationships between cadmium exposure 
and lung cancer. A statistically significant excess of lung cancer 
attributed to cadmium exposure was observed in this study even when 
confounding variables such as co-exposure to arsenic and smoking habits 
were taken into consideration (Ex. L-140-50).
    The primary evidence for quantifying a link between lung cancer and 
cadmium exposure from animal studies derives from two rat bioassay 
studies; one by Takenaka et al., (1983), which is a study of cadmium 
chloride and a second study by Oldiges and Glaser (1990) of four cadmium 
compounds.
    Based on the above cited studies, the U.S. Environmental Protection 
Agency (EPA) classified cadmium as ``B1'', a probable human carcinogen, 
in 1985 (Ex. 4-4). The International Agency for Research on Cancer 
(IARC) in 1987 also recommended that cadmium be listed as ``2A'', a 
probable human carcinogen (Ex. 4-15). The American Conference of 
Governmental Industrial Hygienists (ACGIH) has recently recommended that 
cadmium be labeled as a carcinogen. Since 1984, NIOSH has concluded that 
cadmium is possibly a human carcinogen and has recommended that 
exposures be controlled to the lowest level feasible.

                       4. Non-carcinogenic Effects

    Acute pneumonitis occurs 10 to 24 hours after initial acute 
inhalation of high levels of cadmium fumes with symptoms such as fever 
and chest pain (Exs. 30, 8-86B). In extreme exposure cases pulmonary 
edema may develop and cause death several days after exposure. Little 
actual exposure measurement data is available on the level of airborne 
cadmium exposure that causes such immediate adverse lung effects, 
nonetheless, it is reasonable to believe a cadmium concentration of 
approximately 1 mg/m\3\ over an eight hour period is ``immediately 
dangerous'' (55 FR 4052, ANSI; Ex. 8-86B).
    In addition to acute lung effects and chronic renal effects, long 
term exposure to cadmium may cause other severe effects on the 
respiratory system. Reduced pulmonary function and chronic lung disease 
indicative

[[Page 163]]

of emphysema have been observed in workers who have had prolonged 
exposure to cadmium dust or fumes (Exs. 4-29, 4-22, 4-42, 4-50, 4-63). 
In a study of workers conducted by Kazantzis et al., a statistically 
significant excess of worker deaths due to chronic bronchitis was found, 
which in his opinion was directly related to high cadmium exposures of 1 
mg/m\3\ or more (Tr. 6/8/90, pp. 156-157).
    Cadmium need not be respirable to constitute a hazard. Inspirable 
cadmium particles that are too large to be respirable but small enough 
to enter the tracheobronchial region of the lung can lead to 
bronchoconstriction, chronic pulmonary disease, and cancer of that 
portion of the lung. All of these diseases have been associated with 
occupational exposure to cadmium (Ex. 8-86B). Particles that are 
constrained by their size to the extra-thoracic regions of the 
respiratory system such as the nose and maxillary sinuses can be 
swallowed through mucocillary clearance and be absorbed into the body 
(ACGIH, Ex. 8-692). The impaction of these particles in the upper 
airways can lead to anosmia, or loss of sense of smell, which is an 
early indication of overexposure among workers exposed to heavy metals. 
This condition is commonly reported among cadmium-exposed workers (Ex. 
8-86-B).

                         C. Medical Surveillance

    In general, the main provisions of the medical surveillance section 
of the standard, under paragraphs (l)(1)-(17) of the regulatory text, 
are as follows:
    1. Workers exposed above the action level are covered;
    2. Workers with intermittent exposures are not covered;
    3. Past workers who are covered receive biological monitoring for at 
least one year;
    4. Initial examinations include a medical questionnaire and 
biological monitoring of cadmium in blood (CdB), cadmium in urine (CdU), 
and Beta-2-microglobulin in urine ([beta]2-M);
    5. Biological monitoring of these three analytes is performed at 
least annually; full medical examinations are performed biennially;
    6. Until five years from the effective date of the standard, medical 
removal is required when CdU is greater than 15 [micro]g/gram creatinine 
(g Cr), or CdB is greater than 15 [micro]g/liter whole blood (lwb), or 
[beta]2-M is greater than 1500 [micro]g/g Cr, and CdB is 
greater than 5 [micro]g/lwb or CdU is greater than 3 [micro]g/g Cr;
    7. Beginning five years after the standard is in effect, medical 
removal triggers will be reduced;
    8. Medical removal protection benefits are to be provided for up to 
18 months;
    9. Limited initial medical examinations are required for respirator 
usage;
    10. Major provisions are fully described under section (l) of the 
regulatory text; they are outlined here as follows:
    A. Eligibility
    B. Biological monitoring
    C. Actions triggered by levels of CdU, CdB, and [beta]2-M 
(See Summary Charts and Tables in Attachment-1.)
    D. Periodic medical surveillance
    E. Actions triggered by periodic medical surveillance (See appendix 
A Summary Chart and Tables in Attachment-1.)
    F. Respirator usage
    G. Emergency medical examinations
    H. Termination examination
    I. Information to physician
    J. Physician's medical opinion
    K. Medical removal protection
    L. Medical removal protection benefits
    M. Multiple physician review
    N. Alternate physician review
    O. Information employer gives to employee
    P. Recordkeeping
    Q. Reporting on OSHA form 200
    11. The above mentioned summary of the medical surveillance 
provisions, the summary chart, and tables for the actions triggered at 
different levels of CdU, CdB and [beta]2-M (in appendix A 
Attachment-1) are included only for the purpose of facilitating 
understanding of the provisions of paragraphs (l)(3) of the final 
cadmium standard. The summary of the provisions, the summary chart, and 
the tables do not add to or reduce the requirements in paragraph (l)(3).

                    D. Recommendations to Physicians

    1. It is strongly recommended that patients with tubular proteinuria 
are counseled on: The hazards of smoking; avoidance of nephrotoxins and 
certain prescriptions and over-the-counter medications that may 
exacerbate kidney symptoms; how to control diabetes and/or blood 
pressure; proper hydration, diet, and exercise (Ex. 19-2). A list of 
prominent or common nephrotoxins is attached. (See appendix A 
Attachment-2.)
    2. DO NOT CHELATE; KNOW WHICH DRUGS ARE NEPHROTOXINS OR ARE 
ASSOCIATED WITH NEPHRITIS.
    3. The gravity of cadmium-induced renal damage is compounded by the 
fact there is no medical treatment to prevent or reduce the accumulation 
of cadmium in the kidney (Ex. 8-619). Dr. Friberg, a leading world 
expert on cadmium toxicity, indicated in 1992, that there is no form of 
chelating agent that could be used without substantial risk. He stated 
that tubular proteinuria has to be treated in the same way as other 
kidney disorders (Ex. 29).
    4. After the results of a workers' biological monitoring or medical 
examination are received the employer is required to provide an 
information sheet to the patient, briefly explaining the significance of 
the results. (See Attachment 3 of this appendix A.)

[[Page 164]]

    5. For additional information the physician is referred to the 
following additional resources:
    a. The physician can always obtain a copy of the preamble, with its 
full discussion of the health effects, from OSHA's Computerized 
Information System (OCIS).
    b. The Docket Officer maintains a record of the rulemaking. The 
Cadmium Docket (H-057A), is located at 200 Constitution Ave. NW., room 
N-2625, Washington, DC 20210; telephone: 202-219-7894.
    c. The following articles and exhibits in particular from that 
docket (H-057A):

------------------------------------------------------------------------
    Exhibit number                   Author and paper title
------------------------------------------------------------------------
8-447................  Lauwerys et. al., Guide for physicians, ``Health
                        Maintenance of Workers Exposed to Cadmium,''
                        published by the Cadmium Council.
4-67.................  Takenaka, S., H. Oldiges, H. Konig, D.
                        Hochrainer, G. Oberdorster. ``Carcinogenicity of
                        Cadmium Chloride Aerosols in Wistar Rats''. JNCI
                        70:367-373, 1983. (32)
4-68.................  Thun, M.J., T.M. Schnoor, A.B. Smith, W.E.
                        Halperin, R.A. Lemen. ``Mortality Among a Cohort
                        of U.S. Cadmium Production Workers--An Update.''
                        JNCI 74(2):325-33, 1985. (8)
4-25.................  Elinder, C.G., Kjellstrom, T., Hogstedt, C., et
                        al., ``Cancer Mortality of Cadmium Workers.''
                        Brit. J. Ind. Med. 42:651-655, 1985. (14)
4-26.................  Ellis, K.J. et al., ``Critical Concentrations of
                        Cadmium in Human Renal Cortex: Dose Effect
                        Studies to Cadmium Smelter Workers.'' J.
                        Toxicol. Environ. Health 7:691-703, 1981. (76)
4-27.................  Ellis, K.J., S.H. Cohn and T.J. Smith. ``Cadmium
                        Inhalation Exposure Estimates: Their
                        Significance with Respect to Kidney and Liver
                        Cadmium Burden.'' J. Toxicol. Environ. Health
                        15:173-187, 1985.
4-28.................  Falck, F.Y., Jr., Fine, L.J., Smith, R.G.,
                        McClatchey, K.D., Annesley, T., England, B., and
                        Schork, A.M. ``Occupational Cadmium Exposure and
                        Renal Status.'' Am. J. Ind. Med. 4:541, 1983.
                        (64)
8-86A................  Friberg, L., C.G. Elinder, et al., ``Cadmium and
                        Health a Toxicological and Epidemiological
                        Appraisal, Volume I, Exposure, Dose, and
                        Metabolism.'' CRC Press, Inc., Boca Raton, FL,
                        1986. (Available from the OSHA Technical Data
                        Center)
8-86B................  Friberg, L., C.G. Elinder, et al., ``Cadmium and
                        Health: A Toxicological and Epidemiological
                        Appraisal, Volume II, Effects and Response.''
                        CRC Press, Inc., Boca Raton, FL, 1986.
                        (Available from the OSHA Technical Data Center)
L-140-45.............  Elinder, C.G., ``Cancer Mortality of Cadmium
                        Workers'', Brit. J. Ind. Med., 42, 651-655,
                        1985.
L-140-50.............  Thun, M., Elinder, C.G., Friberg, L, ``Scientific
                        Basis for an Occupational Standard for Cadmium,
                        Am. J. Ind. Med., 20; 629-642, 1991.
------------------------------------------------------------------------

                          V. Information Sheet

    The information sheet (appendix A Attachment-3.) or an equally 
explanatory one should be provided to you after any biological 
monitoring results are reviewed by the physician, or where applicable, 
after any medical examination.

  Attachment 1--Appendix A Summary Chart and Tables A and B of Actions 
                   Triggered by Biological Monitoring

      Appendix A Summary Chart: Section (1)(3) Medical Surveillance

               Categorizing Biological Monitoring Results

    (A) Biological monitoring results categories are set forth in 
Appendix A Table A for the periods ending December 31, 1998 and for the 
period beginning January 1, 1999.
    (B) The results of the biological monitoring for the initial medical 
exam and the subsequent exams shall determine an employee's biological 
monitoring result category.

               Actions Triggered by Biological Monitoring

    (A)
    (i) The actions triggered by biological monitoring for an employee 
are set forth in Appendix A Table B.
    (ii) The biological monitoring results for each employee under 
section (1)(3) shall determine the actions required for that employee. 
That is, for any employee in biological monitoring category C, the 
employer will perform all of the actions for which there is an X in 
column C of Appendix A Table B.
    (iii) An employee is assigned the alphabetical category (``A'' being 
the lowest) depending upon the test results of the three biological 
markers.
    (iv) An employee is assigned category A if monitoring results for 
all three biological markers fall at or below the levels indicated in 
the table listed for category A.
    (v) An employee is assigned category B if any monitoring result for 
any of the three biological markers fall within the range of levels 
indicated in the table listed for category B, providing no result 
exceeds the levels listed for category B.
    (vi) An employee is assigned category C if any monitoring result for 
any of the three biological markers are above the levels listed for 
category C.
    (B) The user of Appendix A Tables A and B should know that these 
tables are provided only to facilitate understanding of the relevant 
provisions of paragraph (l)(3) of this section. Appendix A Tables A and 
B are not meant to add to or subtract from the requirements of those 
provisions.

   Appendix A Table A--Categorization of Biological Monitoring Results

[[Page 165]]



                                          Applicable Through 1998 Only
----------------------------------------------------------------------------------------------------------------
                                                                            Monitoring result categories
                        Biological marker                         ----------------------------------------------
                                                                       A                B                  C
----------------------------------------------------------------------------------------------------------------
Cadmium in urine (CdU) ([micro]g/g creatinine)...................       <=3    3 and <=15  15
[beta]2-microglobulin ([beta]2-M) ([micro]g/g creatinine)........     <=300       300 and  1500*
Cadmium in blood (CdB) ([micro]g/liter whole blood)..............       <=5    5 and <=15  15
----------------------------------------------------------------------------------------------------------------
* If an employee's [beta]2-M levels are above 1,500 [micro]g/g creatinine, in order for mandatory medical
  removal to be required (See Appendix A Table B.), either the employee's CdU level must also be >3 [micro]g/g
  creatinine or CdB level must also be >5 [micro]g/liter whole blood.


                                      Applicable Beginning January 1, 1999
----------------------------------------------------------------------------------------------------------------
                                                                            Monitoring result categories
                        Biological marker                         ----------------------------------------------
                                                                       A                B                  C
----------------------------------------------------------------------------------------------------------------
Cadmium in urine (CdU) ([micro]g/g creatinine)...................       <=3     3 and <=7  7
[beta]2-microglobulin ([beta]2-M) ([micro]g/g creatinine)........     <=300       300 and  750*
Cadmium in blood (CdB) ([micro]g/liter whole blood)..............       <=5    5 and <=10  10
----------------------------------------------------------------------------------------------------------------
* If an employee's [beta]2-M levels are above 750 [micro]g/g creatinine, in order for mandatory medical removal
  to be required (See Appendix A Table B.), either the employee's CdU level must also be >3 [micro]g/g
  creatinine or CdB level must also be >5 [micro]g/liter whole blood.

     Appendix A Table B--Actions Determined by Biological Monitoring

    This table presents the actions required based on the monitoring 
result in Appendix A Table A. Each item is a separate requirement in 
citing non-compliance. For example, a medical examination within 90 days 
for an employee in category B is separate from the requirement to 
administer a periodic medical examination for category B employees on an 
annual basis.

------------------------------------------------------------------------
                                       Monitoring result category
       Required actions        -----------------------------------------
                                    A \1\         B \1\         C \1\
------------------------------------------------------------------------
(1) Biological monitoring:
    (a) Annual................  X
    (b) Semiannual............  ............  X
    (c) Quarterly.............  ............  ............  X
(2) Medical examination:
    (a) Biennial..............  X
    (b) Annual................  ............  X
    (c) Semiannual............  ............  ............  X
    (d) Within 90 days........  ............  X             X
(3) Assess within two weeks:
    (a) Excess cadmium          ............  X             X
     exposure.
    (b) Work practices........  ............  X             X
    (c) Personal hygiene......  ............  X             X
    (d) Respirator usage......  ............  X             X
    (e) Smoking history.......  ............  X             X
    (f) Hygiene facilities....  ............  X             X
    (g) Engineering controls..  ............  X             X
    (h) Correct within 30 days  ............  X             X
    (i) Periodically assess     ............  ............  X
     exposures.
(4) Discretionary medical       ............  X             X
 removal.
(5) Mandatory medical removal.  ............  ............  X \2\
------------------------------------------------------------------------
\1\ For all employees covered by medical surveillance exclusively
  because of exposures prior to the effective date of this standard, if
  they are in Category A, the employer shall follow the requirements of
  paragraphs (l)(3)(i)(B) and (l)(4)(v)(A). If they are in Category B or
  C, the employer shall follow the requirements of paragraphs
  (l)(4)(v)(B)-(C).
\2\ See footnote Appendix A Table A.

              Appendix A--Attachment 2--List of Medications

    A list of the more common medications that a physician, and the 
employee, may wish to review is likely to include some of the following: 
(1) Anticonvulsants: Paramethadione, phenytoin, trimethadone; (2) 
antihypertensive drugs: Captopril, methyldopa; (3) antimicrobials: 
Aminoglycosides, amphotericin B, cephalosporins, ethambutol; (4) 
antineoplastic agents: Cisplatin, methotrexate, mitomycin-C, 
nitrosoureas,

[[Page 166]]

radiation; (4) sulfonamide diuretics: Acetazolamide, chlorthalidone, 
furosemide, thiazides; (5) halogenated alkanes, hydrocarbons, and 
solvents that may occur in some settings: Carbon tetrachloride, ethylene 
glycol, toluene; iodinated radiographic contrast media; nonsteroidal 
anti-inflammatory drugs; and, (7) other miscellaneous compounds: 
Acetominophen, allopurinol, amphetamines, azathioprine, cimetidine, 
cyclosporine, lithium, methoxyflurane, methysergide, D-penicillamine, 
phenacetin, phenendione. A list of drugs associated with acute 
interstitial nephritis includes: (1) Antimicrobial drugs: 
Cephalosporins, chloramphenicol, colistin, erythromycin, ethambutol, 
isoniazid, para-aminosalicylic acid, penicillins, polymyxin B, rifampin, 
sulfonamides, tetracyclines, and vancomycin; (2) other miscellaneous 
drugs: Allopurinol, antipyrene, azathioprine, captopril, cimetidine, 
clofibrate, methyldopa, phenindione, phenylpropanolamine, phenytoin, 
probenecid, sulfinpyrazone, sulfonamid diuretics, triamterene; and, (3) 
metals: Bismuth, gold.
    This list have been derived from commonly available medical 
textbooks (e.g., Ex. 14-18). The list has been included merely to 
facilitate the physician's, employer's, and employee's understanding. 
The list does not represent an official OSHA opinion or policy regarding 
the use of these medications for particular employees. The use of such 
medications should be under physician discretion.

   Attachment 3--Biological Monitoring and Medical Examination Results

Employee________________________________________________________________
Testing Date____________________________________________________________
    Cadmium in Urine ------ [micro]g/g Cr--Normal Levels: <=3 [micro]g/g 
Cr.
    Cadmium in Blood ------ [micro]g/lwb--Normal Levels: <=5 [micro]g/
lwb.
    Beta-2-microglobulin in Urine ------ [micro]g/g Cr--Normal Levels: 
<=300 [micro]g/g Cr.
    Physical Examination Results: N/A ------ Satisfactory ------ 
Unsatisfactory ------ (see physician again).
    Physician's Review of Pulmonary Function Test: N/A ------ Normal --
---- Abnormal ------.
Next biological monitoring or medical examination scheduled for_________
    The biological monitoring program has been designed for three main 
purposes: 1) to identify employees at risk of adverse health effects 
from excess, chronic exposure to cadmium; 2) to prevent cadmium-induced 
disease(s); and 3) to detect and minimize existing cadmium-induced 
disease(s).
    The levels of cadmium in the urine and blood provide an estimate of 
the total amount of cadmium in the body. The amount of a specific 
protein in the urine (beta-2-microglobulin) indicates changes in kidney 
function. All three tests must be evaluated together. A single mildly 
elevated result may not be important if testing at a later time 
indicates that the results are normal and the workplace has been 
evaluated to decrease possible sources of cadmium exposure. The levels 
of cadmium or beta-2-microglobulin may change over a period of days to 
months and the time needed for those changes to occur is different for 
each worker.
    If the results for biological monitoring are above specific ``high 
levels'' [cadmium urine greater than 10 micrograms per gram of 
creatinine ([micro]g/g Cr), cadmium blood greater than 10 micrograms per 
liter of whole blood ([micro]g/lwb), or beta-2-microglobulin greater 
than 1000 micrograms per gram of creatinine ([micro]g/g Cr)], the worker 
has a much greater chance of developing other kidney diseases.
    One way to measure for kidney function is by measuring beta-2-
microglobulin in the urine. Beta-2-microglobulin is a protein which is 
normally found in the blood as it is being filtered in the kidney, and 
the kidney reabsorbs or returns almost all of the beta-2-microglobulin 
to the blood. A very small amount (less than 300 [micro]g/g Cr in the 
urine) of beta-2-microglobulin is not reabsorbed into the blood, but is 
released in the urine. If cadmium damages the kidney, the amount of 
beta-2-microglobulin in the urine increases because the kidney cells are 
unable to reabsorb the beta-2-microglobulin normally. An increase in the 
amount of beta-2-microglobulin in the urine is a very early sign of 
kidney dysfunction. A small increase in beta-2-microglobulin in the 
urine will serve as an early warning sign that the worker may be 
absorbing cadmium from the air, cigarettes contaminated in the 
workplace, or eating in areas that are cadmium contaminated.
    Even if cadmium causes permanent changes in the kidney's ability to 
reabsorb beta-2-microglobulin, and the beta-2-microglobulin is above the 
``high levels'', the loss of kidney function may not lead to any serious 
health problems. Also, renal function naturally declines as people age. 
The risk for changes in kidney function for workers who have biological 
monitoring results between the ``normal values'' and the ``high levels'' 
is not well known. Some people are more cadmium-tolerant, while others 
are more cadmium-susceptible.
    For anyone with even a slight increase of beta-2-microglobulin, 
cadmium in the urine, or cadmium in the blood, it is very important to 
protect the kidney from further damage. Kidney damage can come from 
other sources than excess cadmium-exposure so it is also recommended 
that if a worker's levels are ``high'' he/she should receive counseling 
about drinking more water; avoiding cadmium-tainted tobacco and certain 
medications (nephrotoxins, acetaminophen); controlling diet, vitamin 
intake, blood pressure and diabetes; etc.

[[Page 167]]

   Appendix B to Sec. 1910.1027--Substance Technical Guidelines for 
                                 Cadmium

I. Cadmium Metal
    A. Physical and Chemical Data.
    1. Substance Identification.
    Chemical name: Cadmium.
    Formula: Cd.
    Molecular Weight: 112.4.
    Chemical Abstracts Service (CAS) Registry No.: 7740-43-9.
    Other Identifiers: RETCS EU9800000; EPA D006; DOT 2570 53.
    Synonyms: Colloidal Cadmium: Kadmium (German): CI 77180.
    2. Physical data.
    Boiling point: (760 mm Hg): 765 degrees C.
    Melting point: 321 degrees C.
    Specific Gravity: (H2 O=@ 20 [deg]C): 8.64.
    Solubility: Insoluble in water; soluble in dilute nitric acid and in 
sulfuric acid.
    Appearance: Soft, blue-white, malleable, lustrous metal or grayish-
white powder.
    B. Fire, Explosion and Reactivity Data.
    1. Fire.
    Fire and Explosion Hazards: The finely divided metal is pyrophoric, 
that is the dust is a severe fire hazard and moderate explosion hazard 
when exposed to heat or flame. Burning material reacts violently with 
extinguishing agents such as water, foam, carbon dioxide, and halons.
    Flash point: Flammable (dust).
    Extinguishing media: Dry sand, dry dolomite, dry graphite, or 
sodimum chloride.
    2. Reactivity.
    Conditions contributing to instability: Stable when kept in sealed 
containers under normal temperatures and pressure, but dust may ignite 
upon contact with air. Metal tarnishes in moist air.
    Incompatibilities: Ammonium nitrate, fused: Reacts violently or 
explosively with cadmium dust below 20 [deg]C. Hydrozoic acid: Violent 
explosion occurs after 30 minutes. Acids: Reacts violently, forms 
hydrogen gas. Oxidizing agents or metals: Strong reaction with cadmium 
dust. Nitryl fluoride at slightly elevated temperature: Glowing or white 
incandescence occurs. Selenium: Reacts exothermically. Ammonia: 
Corrosive reaction. Sulfur dioxide: Corrosive reaction. Fire 
extinguishing agents (water, foam, carbon dioxide, and halons): Reacts 
violently. Tellurium: Incandescent reaction in hydrogen atmosphere.
    Hazardous decomposition products: The heated metal rapidly forms 
highly toxic, brownish fumes of oxides of cadmium.
    C. Spill, Leak and Disposal Procedures.
    1. Steps to be taken if the materials is released or spilled. Do not 
touch spilled material. Stop leak if you can do it without risk. Do not 
get water inside container. For large spills, dike spill for later 
disposal. Keep unnecessary people away. Isolate hazard area and deny 
entry. The Superfund Amendments and Reauthorization Act of 1986 Section 
304 requires that a release equal to or greater than the reportable 
quantity for this substance (1 pound) must be immediately reported to 
the local emergency planning committee, the state emergency response 
commission, and the National Response Center (800) 424-8802; in 
Washington, DC metropolitan area (202) 426-2675.
II. Cadmium Oxide
    A. Physical and Chemical Date.
    1. Substance identification.
    Chemical name: Cadmium Oxide.
    Formula: CdO.
    Molecular Weight: 128.4.
    CAS No.: 1306-19-0.
    Other Identifiers: RTECS EV1929500.
    Synonyms: Kadmu tlenek (Polish).
    2. Physical data.
    Boiling point (760 mm Hg): 950 degrees C decomposes.
    Melting point: 1500 [deg]C.
    Specific Gravity: (H2 O=1@20 [deg]C): 7.0.
    Solubility: Insoluble in water; soluble in acids and alkalines.
    Appearance: Red or brown crystals.
    B. Fire, Explosion and Reactivity Data.
    1. Fire.
    Fire and Explosion Hazards: Negligible fire hazard when exposed to 
heat or flame.
    Flash point: Nonflammable.
    Extinguishing media: Dry chemical, carbon dioxide, water spray or 
foam.
    2. Reactivity.
    Conditions contributing to instability: Stable under normal 
temperatures and pressures.
    Incompatibilities: Magnesium may reduce CdO2 explosively 
on heating.
    Hazardous decomposition products: Toxic fumes of cadmium.
    C. Spill Leak and Disposal Procedures.
    1. Steps to be taken if the material is released or spilled. Do not 
touch spilled material. Stop leak if you can do it without risk. For 
small spills, take up with sand or other absorbent material and place 
into containers for later disposal. For small dry spills, use a clean 
shovel to place material into clean, dry container and then cover. Move 
containers from spill area. For larger spills, dike far ahead of spill 
for later disposal. Keep unnecessary people away. Isolate hazard area 
and deny entry. The Superfund Amendments and Reauthorization Act of 1986 
Section 304 requires that a release equal to or greater than the 
reportable quantity for this substance (1 pound) must be immediately 
reported to the local emergency planning committee, the state emergency 
response commission, and the National Response Center (800) 424-8802; in 
Washington, DC metropolitan area (202) 426-2675.
    III. Cadmium Sulfide.
    A. Physical and Chemical Data.
    1. Substance Identification.
    Chemical name: Cadmium sulfide.
    Formula: CdS.

[[Page 168]]

    Molecular weight: 144.5.
    CAS No. 1306-23-6.
    Other Identifiers: RTECS EV3150000.
    Synonyms: Aurora yellow; Cadmium Golden 366; Cadmium Lemon Yellow 
527; Cadmium Orange; Cadmium Primrose 819; Cadmium Sulphide; Cadmium 
Yellow; Cadmium Yellow 000; Cadmium Yellow Conc. Deep; Cadmium Yellow 
Conc. Golden; Cadmium Yellow Conc. Lemon; Cadmium Yellow Conc. Primrose; 
Cadmium Yellow Oz. Dark; Cadmium Yellow Primrose 47-1400; Cadmium Yellow 
10G Conc.; Cadmium Yellow 892; Cadmopur Golden Yellow N; Cadmopur 
Yellow: Capsebon; C.I. 77199; C.I. Pigment Orange 20; CI Pigment Yellow 
37; Ferro Lemon Yellow; Ferro Orange Yellow; Ferro Yellow; Greenockite; 
NCI-C02711.
    2. Physical data.
    Boiling point (760 mm. Hg): sublines in N2 at 980 [deg]C.
    Melting point: 1750 degrees C (100 atm).
    Specific Gravity: (H2 O=1@ 20 [deg]C): 4.82.
    Solubility: Slightly soluble in water; soluble in acid.
    Appearance: Light yellow or yellow-orange crystals.
    B. Fire, Explosion and Reactivity Data.
    1. Fire.
    Fire and Explosion Hazards: Neglible fire hazard when exposed to 
heat or flame.
    Flash point: Nonflammable.
    Extinguishing media: Dry chemical, carbon dioxide, water spray or 
foam.
    2. Reactivity.
    Conditions contributing to instability: Generally non-reactive under 
normal conditions. Reacts with acids to form toxic hydrogen sulfide gas.
    Incompatibilities: Reacts vigorously with iodinemonochloride.
    Hazardous decomposition products: Toxic fumes of cadmium and sulfur 
oxides.
    C. Spill Leak and Disposal Procedures.
    1. Steps to be taken if the material is released or spilled. Do not 
touch spilled material. Stop leak if you can do it without risk. For 
small, dry spills, with a clean shovel place material into clean, dry 
container and cover. Move containers from spill area. For larger spills, 
dike far ahead of spill for later disposal. Keep unnecessary people 
away. Isolate hazard and deny entry.
    IV. Cadmium Chloride.
    A. Physical and Chemical Data.
    1. Substance Identification.
    Chemcail name: Cadmium chloride.
    Formula: CdC12.
    Molecular weight: 183.3.
    CAS No. 10108-64-2.
    Other Identifiers: RTECS EY0175000.
    Synonyms: Caddy; Cadmium dichloride; NA 2570 (DOT); UI-CAD; 
dichlorocadmium.
    2. Physical data.
    Boiling point (760 mm Hg): 960 degrees C.
    Melting point: 568 degrees C.
    Specific Gravity: (H2 O=1 @ 20 [deg]C): 4.05.
    Solubility: Soluble in water (140 g/100 cc); soluble in acetone.
    Appearance: Small, white crystals.
    B. Fire, Explosion and Reactivity Data.
    1. Fire.
    Fire and Explosion Hazards: Negligible fire and negligible explosion 
hazard in dust form when exposed to heat or flame.
    Flash point: Nonflamable.
    Extinguishing media: Dry chemical, carbon dioxide, water spray or 
foam.
    2. Reactivity.
    Conditions contributing to instability: Generally stable under 
normal temperatures and pressures.
    Incompatibilities: Bromine triflouride rapidly attacks cadmium 
chloride. A mixture of potassium and cadmium chloride may produce a 
strong explosion on impact.
    Hazardous decomposition products: Thermal ecompostion may release 
toxic fumes of hydrogen chloride, chloride, chlorine or oxides of 
cadmium.
    C. Spill Leak and Disposal Procedures.
    1. Steps to be taken if the materials is released or spilled. Do not 
touch spilled material. Stop leak if you can do it without risk. For 
small, dry spills, with a clean shovel place material into clean, dry 
container and cover. Move containers from spill area. For larger spills, 
dike far ahead of spill for later disposal. Keep unnecessary people 
away. Isolate hazard and deny entry. The Superfund Amendments and 
Reauthorization Act of 1986 Section 304 requires that a release equal to 
or greater than the reportable quantity for this substance (100 pounds) 
must be immediately reported to the local emergency planning committee, 
the state emergency response commission, and the National Response 
Center (800) 424-8802; in Washington, DC Metropolitan area (202) 426-
2675.

                Appendix C to Sec. 1910.1027 [Reserved]

  Appendix D to Sec. 1910.1027--Occupational Health History Interview 
                   With Reference to Cadmium Exposure

                               Directions

(To be read by employee and signed prior to the interview)

    Please answer the questions you will be asked as completely and 
carefully as you can. These questions are asked of everyone who works 
with cadmium. You will also be asked to give blood and urine samples. 
The doctor will give your employer a written opinion on whether you are 
physically capable of working with cadmium. Legally, the doctor cannot 
share personal information you may tell him/her with your employer. The 
following information is considered strictly confidential. The results 
of the tests will go to you, your doctor and your employer. You will 
also receive an information sheet explaining the results of any 
biological

[[Page 169]]

monitoring or physical examinations performed.
    If you are just being hired, the results of this interview and 
examination will be used to:
    (1) Establish your health status and see if working with cadmium 
might be expected to cause unusual problems,
    (2) Determine your health status today and see if there are changes 
over time,
    (3) See if you can wear a respirator safely.
    If you are not a new hire:
    OSHA says that everyone who works with cadmium can have periodic 
medical examinations performed by a doctor. The reasons for this are:
    (a) If there are changes in your health, either because of cadmium 
or some other reason, to find them early,
    (b) to prevent kidney damage.

Please sign below.

    I have read these directions and understand them:

________________________________________________________________________
Employee signature

________________________________________________________________________
Date

    Thank you for answering these questions. (Suggested Format)
Name____________________________________________________________________
Age_____________________________________________________________________
Social Security _______________________________________________
Company_________________________________________________________________
Job_____________________________________________________________________
    Type of Preplacement Exam:
    [ ] Periodic
    [ ] Termination
    [ ] Initial
    [ ] Other
Blood Pressure__________________________________________________________
Pulse Rate______________________________________________________________
1. How long have you worked at the job listed above?
    [ ] Not yet hired
    [ ] Number of months
    [ ] Number of years
2. Job Duties etc.

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
3. Have you ever been told by a doctor that you had bronchitis?
    [ ] Yes
    [ ] No
    If yes, how long ago?
    [ ] Number of months
    [ ] Number of years
4. Have you ever been told by a doctor that you had emphysema?
    [ ] Yes
    [ ] No
    If yes, how long ago?
    [ ] Number of years
    [ ] Number of months
5. Have you ever been told by a doctor that you had other lung problems?
    [ ] Yes
    [ ] No
    If yes, please describe type of lung problems and when you had these 
problems
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
6. In the past year, have you had a cough?
    [ ] Yes
    [ ] No
    If yes, did you cough up sputum?
    [ ] Yes
    [ ] No
    If yes, how long did the cough with sputum production last?
    [ ] Less than 3 months
    [ ] 3 months or longer
    If yes, for how many years have you had episodes of cough with 
sputum production lasting this long?
    [ ] Less than one
    [ ] 1
    [ ] 2
    [ ] Longer than 2
7. Have you ever smoked cigarettes?
    [ ] Yes
    [ ] No
8. Do you now smoke cigarettes?
    [ ] Yes
    [ ] No
9. If you smoke or have smoked cigarettes, for how many years have you 
          smoked, or did you smoke?
    [ ] Less than 1 year
    [ ] Number of years
    What is or was the greatest number of packs per day that you have 
smoked?
    [ ] Number of packs
    If you quit smoking cigarettes, how many years ago did you quit?
    [ ] Less than 1 year
    [ ] Number of years
    How many packs a day do you now smoke?
    [ ] Number of packs per day
10. Have you ever been told by a doctor that you had a kidney or urinary 
          tract disease or disorder?
    [ ] Yes
    [ ] No
11. Have you ever had any of these disorders?

Kidney stones......................  [ ] Yes            [ ] No
Protein in urine...................  [ ] Yes            [ ] No
Blood in urine.....................  [ ] Yes            [ ] No
Difficulty urinating...............  [ ] Yes            [ ] No
Other kidney/Urinary disorders.....  [ ] Yes            [ ] No
 

    Please describe problems, age, treatment, and follow up for any 
kidney or urinary problems you have had:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
12. Have you ever been told by a doctor or other health care provider 
          who took your blood pressure that your blood pressure was 
          high?

[[Page 170]]

    [ ] Yes
    [ ] No
13. Have you ever been advised to take any blood pressure medication?
    [ ] Yes
    [ ] No
14. Are you presently taking any blood pressure medication?
    [ ] Yes
    [ ] No
15. Are you presently taking any other medication?
    [ ] Yes
    [ ] No
16. Please list any blood pressure or other medications and describe how 
          long you have been taking each one:

Medicine:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

How Long Taken
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
17. Have you ever been told by a doctor that you have diabetes? (sugar 
          in your blood or urine)
    [ ] Yes
    [ ] No
    If yes, do you presently see a doctor about your diabetes?
    [ ] Yes
    [ ] No
    If yes, how do you control your blood sugar?
    [ ] Diet alone
    [ ] Diet plus oral medicine
    [ ] Diet plus insulin (injection)
18. Have you ever been told by a doctor that you had:

Anemia.............................  [ ] Yes            [ ] No
A low blood count?.................  [ ] Yes            [ ] No
 

19. Do you presently feel that you tire or run out of energy sooner than 
          normal or sooner than other people your age?
    [ ] Yes
    [ ] No
    If yes, for how long have you felt that you tire easily?
    [ ] Less than 1 year
    [ ] Number of years
20. Have you given blood within the last year?
    [ ] Yes
    [ ] No
    If yes, how many times?
    [ ] Number of times
    How long ago was the last time you gave blood?
    [ ] Less than 1 month
    [ ] Number of months
21. Within the last year have you had any injuries with heavy bleeding?
    [ ] Yes
    [ ] No
    If yes, how long ago?
    [ ] Less than 1 month
    [ ] Number of months
Describe:_______________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
22. Have you recently had any surgery?
    [ ] Yes
    [ ] No
If yes, please describe:________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
23. Have you seen any blood lately in your stool or after a bowel 
          movement?
    [ ] Yes
    [ ] No
24. Have you ever had a test for blood in your stool?
    [ ] Yes
    [ ] No
    If yes, did the test show any blood in the stool?
    [ ] Yes
    [ ] No
What further evaluation and treatment were done?________________________
________________________________________________________________________
________________________________________________________________________
    The following questions pertain to the ability to wear a respirator. 
Additional information for the physician can be found in The Respiratory 
Protective Devices Manual.
25. Have you ever been told by a doctor that you have asthma?
    [ ] Yes
    [ ] No
    If yes, are you presently taking any medication for asthma? Mark all 
that apply.
    [ ] Shots
    [ ] Pills
    [ ] Inhaler
26. Have you ever had a heart attack?
    [ ] Yes
    [ ] No
    If yes, how long ago?
    [ ] Number of years
    [ ] Number of months
27. Have you ever had pains in your chest?
    [ ] Yes
    [ ] No
    If yes, when did it usually happen?
    [ ] While resting
    [ ] While working
    [ ] While exercising
    [ ] Activity didn't matter
28. Have you ever had a thyroid problem?
    [ ] Yes
    [ ] No
29. Have you ever had a seizure or fits?
    [ ] Yes
    [ ] No
30. Have you ever had a stroke (cerebrovascular accident)?
    [ ] Yes
    [ ] No

[[Page 171]]

31. Have you ever had a ruptured eardrum or a serious hearing problem?
    [ ] Yes
    [ ] No
32. Do you now have a claustrophobia, meaning fear of crowded or closed 
          in spaces or any psychological problems that would make it 
          hard for you to wear a respirator?
    [ ] Yes
    [ ] No
    The following questions pertain to reproductive history.
33. Have you or your partner had a problem conceiving a child?
    [ ] Yes
    [ ] No
    If yes, specify:
    [ ] Self
    [ ] Present mate
    [ ] Previous mate
34. Have you or your partner consulted a physician for a fertility or 
          other reproductive problem?
    [ ] Yes
    [ ] No
    If yes, specify who consulted the physician:
    [ ] Self
    [ ] Spouse/partner
    [ ] Self and partner
If yes, specify diagnosis made:_________________________________________
________________________________________________________________________
________________________________________________________________________
35. Have you or your partner ever conceived a child resulting in a 
          miscarriage, still birth or deformed offspring?
    [ ] Yes
    [ ] No
    If yes, specify:
    [ ] Miscarriage
    [ ] Still birth
    [ ] Deformed offspring
If outcome was a deformed offspring, please specify type:_______________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
36. Was this outcome a result of a pregnancy of:
    [ ] Yours with present partner
    [ ] Yours with a previous partner
37. Did the timing of any abnormal pregnancy outcome coincide with 
          present employment?
    [ ] Yes
    [ ] No
List dates of occurrences:______________________________________________
________________________________________________________________________
38. What is the occupation of your spouse or partner?
________________________________________________________________________
________________________________________________________________________

                             For Women Only

39. Do you have menstrual periods?
    [ ] Yes
    [ ] No
    Have you had menstrual irregularities?
    [ ] Yes
    [ ] No
If yes, specify type:___________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
If yes, what was the approximated date this problem began?______________
________________________________________________________________________
Approximate date problem stopped?_______________________________________
________________________________________________________________________

                              For Men Only

40. Have you ever been diagnosed by a physician as having prostate gland 
          problem(s)?
    [ ] Yes
    [ ] No
If yes, please describe type of problem(s) and what was done to evaluate 
and treat the problem(s):_______________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

     Appendix E to Sec. 1910.1027--Cadmium in Workplace Atmospheres

Method Number: ID-189
Matrix: Air
OSHA Permissible Exposure Limits: 5 [micro]g/m\3\ (TWA), 2.5 [micro]g/
          m\3\ (Action Level TWA)
Collection Procedure: A known volume of air is drawn through a 37-mm 
          diameter filter cassette containing a 0.8-[micro]m mixed 
          cellulose ester membrane filter (MCEF).
Recommended Air Volume: 960 L
Recommended Sampling Rate: 2.0 L/min
Analytical Procedure: Air filter samples are digested with nitric acid. 
          After digestion, a small amount of hydrochloric acid is added. 
          The samples are then diluted to volume with deionized water 
          and analyzed by either flame atomic absorption spectroscopy 
          (AAS) or flameless atomic absorption spectroscopy using a 
          heated graphite furnace atomizer (AAS-HGA).
Detection Limits:
Qualitative: 0.2 [micro]g/m\3\ for a 200 L sample by Flame AAS, 0.007 
          [micro]g/m\3\ for a 60 L sample by AAS-HGA
Quantitative: 0.70 [micro]g/m\3\ for a 200 L sample by Flame AAS, 0.025 
          [micro]g/m\3\ for a 60 L sample by AAS-HGA
Precision and Accuracy: (Flame AAS Analysis and AAS-HGA Analysis):
    Validation Level: 2.5 to 10 [micro]g/m\3\ for a 400 L air vol, 1.25 
to 5.0 [micro]g/m\3\ for a 60 L air vol
    CV1 (pooled): 0.010, 0.043
Analytical Bias: +4.0%, -5.8%
Overall Analytical Error:6.0%, 14.2%
Method Classification: Validated
Date: June, 1992
    Inorganic Service Branch II, OSHA Salt Lake Technical Center, Salt 
Lake City, Utah
    Commercial manufacturers and products mentioned in this method are 
for descriptive

[[Page 172]]

use only and do not constitute endorsements by USDOL-OSHA. Similar 
products from other sources can be substituted.

                             1. Introduction

                               1.1. Scope

    This method describes the collection of airborne elemental cadmium 
and cadmium compounds on 0.8-[micro]m mixed cellulose ester membrane 
filters and their subsequent analysis by either flame atomic absorption 
spectroscopy (AAS) or flameless atomic absorption spectroscopy using a 
heated graphite furnace atomizer (AAS-HGA). It is applicable for both 
TWA and Action Level TWA Permissible Exposure Level (PEL) measurements. 
The two atomic absorption analytical techniques included in the method 
do not differentiate between cadmium fume and cadmium dust samples. They 
also do not differentiate between elemental cadmium and its compounds.

                             1.2. Principle

    Airborne elemental cadmium and cadmium compounds are collected on a 
0.8-[micro]m mixed cellulose ester membrane filter (MCEF). The air 
filter samples are digested with concentrated nitric acid to destroy the 
organic matrix and dissolve the cadmium analytes. After digestion, a 
small amount of concentrated hydrochloric acid is added to help dissolve 
other metals which may be present. The samples are diluted to volume 
with deionized water and then aspirated into the oxidizing air/acetylene 
flame of an atomic absorption spectrophotometer for analysis of 
elemental cadmium.
    If the concentration of cadmium in a sample solution is too low for 
quantitation by this flame AAS analytical technique, and the sample is 
to be averaged with other samples for TWA calculations, aliquots of the 
sample and a matrix modifier are later injected onto a L'vov platform in 
a pyrolytically-coated graphite tube of a Zeeman atomic absorption 
spectrophotometer/graphite furnace assembly for analysis of elemental 
cadmium. The matrix modifier is added to stabilize the cadmium metal and 
minimize sodium chloride as an interference during the high temperature 
charring step of the analysis (5.1., 5.2.).

                              1.3. History

    Previously, two OSHA sampling and analytical methods for cadmium 
were used concurrently (5.3., 5.4.). Both of these methods also required 
0.8-[micro]m mixed cellulose ester membrane filters for the collection 
of air samples. These cadmium air filter samples were analyzed by either 
flame atomic absorption spectroscopy (5.3.) or inductively coupled 
plasma/atomic emission spectroscopy (ICP-AES) (5.4.). Neither of these 
two analytical methods have adequate sensitivity for measuring workplace 
exposure to airborne cadmium at the new lower TWA and Action Level TWA 
PEL levels when consecutive samples are taken on one employee and the 
sample results need to be averaged with other samples to determine a 
single TWA.
    The inclusion of two atomic absorption analytical techniques in the 
new sampling and analysis method for airborne cadmium permits 
quantitation of sample results over a broad range of exposure levels and 
sampling periods. The flame AAS analytical technique included in this 
method is similar to the previous procedure given in the General Metals 
Method ID-121 (5.3.) with some modifications. The sensitivity of the 
AAS-HGA analytical technique included in this method is adequate to 
measure exposure levels at 1/10 the Action Level TWA, or lower, when 
less than full-shift samples need to be averaged together.

                         1.4. Properties (5.5.)

    Elemental cadmium is a silver-white, blue-tinged, lustrous metal 
which is easily cut with a knife. It is slowly oxidized by moist air to 
form cadmium oxide. It is insoluble in water, but reacts readily with 
dilute nitric acid. Some of the physical properties and other 
descriptive information of elemental cadmium are given below:

CAS No.........................................................7440-43-9
Atomic Number.........................................................48
Atomic Symbol.........................................................Cd
Atomic Weight.....................................................112.41
Melting Point.................................................321 [deg]C
Boiling Point.................................................765 [deg]C
Density............................................8.65 g/mL (25 [deg]C)

    The properties of specific cadmium compounds are described in 
reference 5.5.

                         1.5. Method Performance

    A synopsis of method performance is presented below. Further 
information can be found in Section 4.
    1.5.1. The qualitative and quantitative detection limits for the 
flame AAS analytical technique are 0.04 [micro]g (0.004 [micro]g/mL) and 
0.14 [micro]g (0.014 [micro]g/mL) cadmium, respectively, for a 10 mL 
solution volume. These correspond, respectively, to 0.2 [micro]g/m\3\ 
and 0.70 [micro]g/m\3\ for a 200 L air volume.
    1.5.2. The qualitative and quantitative detection limits for the 
AAS-HGA analytical technique are 0.44 ng (0.044 ng/mL) and 1.5 ng (0.15 
ng/mL) cadmium, respectively, for a 10 mL solution volume. These 
correspond, respectively, to 0.007 [micro]g/m\3\ and 0.025 [micro]g/m\3\ 
for a 60 L air volume.
    1.5.3. The average recovery by the flame AAS analytical technique of 
17 spiked MCEF samples containing cadmium in the range of 0.5 to 2.0 
times the TWA target concentration of 5 [micro]g/m\3\ (assuming a 400 L 
air volume) was 104.0% with a pooled coefficient of variation 
(CV1) of 0.010. The flame analytical

[[Page 173]]

technique exhibited a positive bias of +4.0% for the validated 
concentration range. The overall analytical error (OAE) for the flame 
AAS analytical technique was 6.0%.
    1.5.4. The average recovery by the AAS-HGA analytical technique of 
18 spiked MCEF samples containing cadmium in the range of 0.5 to 2.0 
times the Action Level TWA target concentration of 2.5 [micro]g/m\3\ 
(assuming a 60 L air volume) was 94.2% with a pooled coefficient of 
variation (CV1) of 0.043. The AAS-HGA analytical technique 
exhibited a negative bias of -5.8% for the validated concentration 
range. The overall analytical error (OAE) for the AAS-HGA analytical 
technique was 14.2%.
    1.5.5. Sensitivity in flame atomic absorption is defined as the 
characteristic concentration of an element required to produce a signal 
of 1% absorbance (0.0044 absorbance units). Sensitivity values are 
listed for each element by the atomic absorption spectrophotometer 
manufacturer and have proved to be a very valuable diagnostic tool to 
determine if instrumental parameters are optimized and if the instrument 
is performing up to specification. The sensitivity of the 
spectrophotometer used in the validation of the flame AAS analytical 
technique agreed with the manufacturer specifications (5.6.); the 2 
[micro]g/mL cadmium standard gave an absorbance reading of 0.350 abs. 
units.
    1.5.6. Sensitivity in graphite furnace atomic absorption is defined 
in terms of the characteristic mass, the number of picograms required to 
give an integrated absorbance value of 0.0044 absorbance-second (5.7.). 
Data suggests that under Stabilized Temperature Platform Furnace (STPF) 
conditions (see Section 1.6.2.), characteristic mass values are 
transferable between properly functioning instruments to an accuracy of 
about 20% (5.2.). The characteristic mass for STPF analysis of cadmium 
with Zeeman background correction listed by the manufacturer of the 
instrument used in the validation of the AAS-HGA analytical technique 
was 0.35 pg. The experimental characteristic mass value observed during 
the determination of the working range and detection limits of the AAS-
HGA analytical technique was 0.41 pg.

                           1.6. Interferences

    1.6.1. High concentrations of silicate interfere in determining 
cadmium by flame AAS (5.6.). However, silicates are not significantly 
soluble in the acid matrix used to prepare the samples.
    1.6.2. Interferences, such as background absorption, are reduced to 
a minimum in the AAS-HGA analytical technique by taking full advantage 
of the Stabilized Temperature Platform Furnace (STPF) concept. STPF 
includes all of the following parameters (5.2.):

a. Integrated Absorbance,
b. Fast Instrument Electronics and Sampling Frequency,
c. Background Correction,
d. Maximum Power Heating,
e. Atomization off the L'vov platform in a pyrolytically coated graphite 
tube,
f. Gas Stop during Atomization,
g. Use of Matrix Modifiers.

                         1.7. Toxicology (5.14.)

    Information listed within this section is synopsis of current 
knowledge of the physiological effects of cadmium and is not intended to 
be used as the basis for OSHA policy. IARC classifies cadmium and 
certain of its compounds as Group 2A carcinogens (probably carcinogenic 
to humans). Cadmium fume is intensely irritating to the respiratory 
tract. Workplace exposure to cadmium can cause both chronic and acute 
effects. Acute effects include tracheobronchitis, pneumonitis, and 
pulmonary edema. Chronic effects include anemia, rhinitis/anosmia, 
pulmonary emphysema, proteinuria and lung cancer. The primary target 
organs for chronic disease are the kidneys (non-carcinogenic) and the 
lungs (carcinogenic).

                               2. Sampling

                             2.1. Apparatus

    2.1.1. Filter cassette unit for air sampling: A 37-mm diameter mixed 
cellulose ester membrane filter with a pore size of 0.8-[micro]m 
contained in a 37-mm polystyrene two- or three-piece cassette filter 
holder (part no. MAWP 037 A0, Millipore Corp., Bedford, MA). The filter 
is supported with a cellulose backup pad. The cassette is sealed prior 
to use with a shrinkable gel band.
    2.1.2. A calibrated personal sampling pump whose flow is determined 
to an accuracy of 5% at the recommended flow rate 
with the filter cassette unit in line.

                             2.2. Procedure

    2.2.1. Attach the prepared cassette to the calibrated sampling pump 
(the backup pad should face the pump) using flexible tubing. Place the 
sampling device on the employee such that air is sampled from the 
breathing zone.
    2.2.2. Collect air samples at a flow rate of 2.0 L/min. If the 
filter does not become overloaded, a full-shift (at least seven hours) 
sample is strongly recommended for TWA and Action Level TWA measurements 
with a maximum air volume of 960 L. If overloading occurs, collect 
consecutive air samples for shorter sampling periods to cover the full 
workshift.
    2.2.3. Replace the end plugs into the filter cassettes immediately 
after sampling. Record the sampling conditions.

[[Page 174]]

    2.2.4. Securely wrap each sample filter cassette end-to-end with an 
OSHA Form 21 sample seal.
    2.2.5. Submit at least one blank sample with each set of air 
samples. The blank sample should be handled the same as the other 
samples except that no air is drawn through it.
    2.2.6. Ship the samples to the laboratory for analysis as soon as 
possible in a suitable container designed to prevent damage in transit.

                               3. Analysis

                         3.1. Safety Precautions

    3.1.1. Wear safety glasses, protective clothing and gloves at all 
times.
    3.1.2. Handle acid solutions with care. Handle all cadmium samples 
and solutions with extra care (see Sect. 1.7.). Avoid their direct 
contact with work area surfaces, eyes, skin and clothes. Flush acid 
solutions which contact the skin or eyes with copious amounts of water.
    3.1.3. Perform all acid digestions and acid dilutions in an exhaust 
hood while wearing a face shield. To avoid exposure to acid vapors, do 
not remove beakers containing concentrated acid solutions from the 
exhaust hood until they have returned to room temperature and have been 
diluted or emptied.
    3.1.4. Exercise care when using laboratory glassware. Do not use 
chipped pipets, volumetric flasks, beakers or any glassware with sharp 
edges exposed in order to avoid the possibility of cuts or abrasions.
    3.1.5. Never pipet by mouth.
    3.1.6. Refer to the instrument instruction manuals and SOPs (5.8., 
5.9.) for proper and safe operation of the atomic absorption 
spectrophotometer, graphite furnace atomizer and associated equipment.
    3.1.7. Because metallic elements and other toxic substances are 
vaporized during AAS flame or graphite furnace atomizer operation, it is 
imperative that an exhaust vent be used. Always ensure that the exhaust 
system is operating properly during instrument use.

           3.2. Apparatus for Sample and Standard Preparation

    3.2.1. Hot plate, capable of reaching 150 [deg]C, installed in an 
exhaust hood.
    3.2.2. Phillips beakers, 125 mL.
    3.2.3. Bottles, narrow-mouth, polyethylene or glass with leakproof 
caps: used for storage of standards and matrix modifier.
    3.2.4. Volumetric flasks, volumetric pipets, beakers and other 
associated general laboratory glassware.
    3.2.5. Forceps and other associated general laboratory equipment.

                  3.3. Apparatus for Flame AAS Analysis

    3.3.1. Atomic absorption spectrophotometer consisting of a(an):

Nebulizer and burner head
Pressure regulating devices capable of maintaining constant oxidant and 
fuel pressures
Optical system capable of isolating the desired wavelength of radiation 
(228.8 nm)
Adjustable slit
Light measuring and amplifying device
Display, strip chart, or computer interface for indicating the amount of 
absorbed radiation
Cadmium hollow cathode lamp or electrodeless discharge lamp (EDL) and 
power supply

    3.3.2. Oxidant: compressed air, filtered to remove water, oil and 
other foreign substances.
    3.3.3. Fuel: standard commercially available tanks of acetylene 
dissolved in acetone; tanks should be equipped with flash arresters.

    Caution: Do not use grades of acetylene containing solvents other 
than acetone because they may damage the PVC tubing used in some 
instruments.

    3.3.4. Pressure-reducing valves: two gauge, two-stage pressure 
regulators to maintain fuel and oxidant pressures somewhat higher than 
the controlled operating pressures of the instrument.
    3.3.5. Exhaust vent installed directly above the spectrophotometer 
burner head.

                   3.4. Apparatus for AAS-HGA Analysis

    3.4.1. Atomic absorption spectrophotometer consisting of a(an):

Heated graphite furnace atomizer (HGA) with argon purge system
Pressure-regulating devices capable of maintaining constant argon purge 
pressure
Optical system capable of isolating the desired wavelength of radiation 
(228.8 nm)
Adjustable slit
Light measuring and amplifying device
Display, strip chart, or computer interface for indicating the amount of 
absorbed radiation (as integrated absorbance, peak area)
Background corrector: Zeeman or deuterium arc. The Zeeman background 
corrector is recommended
Cadmium hollow cathode lamp or electrodeless discharge lamp (EDL) and 
power supply
Autosampler capable of accurately injecting 5 to 20 [micro]L sample 
aliquots onto the L'vov Platform in a graphite tube

    3.4.2. Pyrolytically coated graphite tubes containing solid, 
pyrolytic L'vov platforms.
    3.4.3. Polyethylene sample cups, 2.0 to 2.5 mL, for use with the 
autosampler.
    3.4.4. Inert purge gas for graphite furnace atomizer: compressed gas 
cylinder of purified argon.

[[Page 175]]

    3.4.5. Two gauge, two-stage pressure regulator for the argon gas 
cylinder.
    3.4.6. Cooling water supply for graphite furnace atomizer.
    3.4.7. Exhaust vent installed directly above the graphite furnace 
atomizer.

                              3.5. Reagents

    All reagents should be ACS analytical reagent grade or better.
    3.5.1. Deionized water with a specific conductance of less than 10 
[micro]S.
    3.5.2. Concentrated nitric acid, HNO3.
    3.5.3. Concentrated hydrochloric acid, HCl.
    3.5.4. Ammonium phosphate, monobasic, NH4 H2 
PO4.
    3.5.5. Magnesium nitrate, Mg(NO3)2 [middot] 
6H2 O.
    3.5.6. Diluting solution (4% HNO3, 0.4% HCl): Add 40 mL 
HNO3 and 4 mL HCl carefully to approximately 500 mL deionized 
water and dilute to 1 L with deionized water.
    3.5.7. Cadmium standard stock solution, 1,000 [micro]g/mL: Use a 
commercially available certified 1,000 [micro]g/mL cadmium standard or, 
alternatively, dissolve 1.0000 g of cadmium metal in a minimum volume of 
1:1 HCl and dilute to 1 L with 4% HNO3. Observe expiration 
dates of commercial standards. Properly dispose of commercial standards 
with no expiration dates or prepared standards one year after their 
receipt or preparation date.
    3.5.8. Matrix modifier for AAS-HGA analysis: Dissolve 1.0 g 
NH4 H2 PO4 and 0.15 g 
Mg(NO3)2 [middot] 6H2 O in 
approximately 200 mL deionized water. Add 1 mL HNO3 and 
dilute to 500 mL with deionized water.
    3.5.9 Nitric Acid, 1:1 HNO3/DI H2 O mixture: 
Carefully add a measured volume of concentrated HNO3 to an 
equal volume of DI H2 O.
    3.5.10. Nitric acid, 10% v/v: Carefully add 100 mL of concentrated 
HNO3 to 500 mL of DI H2 O and dilute to 1 L.

                       3.6. Glassware Preparation

    3.6.1. Clean Phillips beakers by refluxing with 1:1 nitric acid on a 
hot plate in a fume hood. Thoroughly rinse with deionized water and 
invert the beakers to allow them to drain dry.
    3.6.2. Rinse volumetric flasks and all other glassware with 10% 
nitric acid and deionized water prior to use.

            3.7. Standard Preparation for Flame AAS Analysis

    3.7.1. Dilute stock solutions: Prepare 1, 5, 10 and 100 [micro]g/mL 
cadmium standard stock solutions by making appropriate serial dilutions 
of 1,000 [micro]g/mL cadmium standard stock solution with the diluting 
solution described in Section 3.5.6.
    3.7.2. Working standards: Prepare cadmium working standards in the 
range of 0.02 to 2.0 [micro]g/mL by making appropriate serial dilutions 
of the dilute stock solutions with the same diluting solution. A 
suggested method of preparation of the working standards is given below.

------------------------------------------------------------------------
                                            Std                  Final
            Working standard              solution   Aliquot      vol.
------------------------------------------------------------------------
([micro]g/mL)                            ([micro]g/      (mL)       (mL)
                                               mL)
------------------------------------------------------------------------
0.02...................................          1         10        500
0.05...................................          5          5        500
0.1....................................         10          5        500
0.2....................................         10         10        500
0.5....................................         10         25        500
1......................................        100          5        500
2......................................        100         10        500

    Store the working standards in 500-mL, narrow-mouth polyethylene or 
glass bottles with leak proof caps. Prepare every twelve months.

             3.8. Standard Preparation for AAS-HGA Analysis

    3.8.1. Dilute stock solutions: Prepare 10, 100 and 1,000 ng/mL 
cadmium standard stock solutions by making appropriate ten-fold serial 
dilutions of the 1,000 [micro]g/mL cadmium standard stock solution with 
the diluting solution described in Section 3.5.6.
    3.8.2. Working standards: Prepare cadmium working standards in the 
range of 0.2 to 20 ng/mL by making appropriate serial dilutions of the 
dilute stock solutions with the same diluting solution. A suggested 
method of preparation of the working standards is given below.

------------------------------------------------------------------------
                                            Std                  Final
            Working standard              solution   Aliquot      vol.
------------------------------------------------------------------------
                (ng/mL)                    (ng/mL)       (mL)       (mL)
------------------------------------------------------------------------
0.2....................................         10          2        100
0.5....................................         10          5        100
1......................................         10         10        100
2......................................        100          2        100
5......................................        100          5        100
10.....................................        100         10        100
20.....................................      1,000          2        100

    Store the working standards in narrow-mouth polyethylene or glass 
bottles with leakproof caps. Prepare monthly.

                         3.9. Sample Preparation

    3.9.1. Carefully transfer each sample filter with forceps from its 
filter cassette unit to a clean, separate 125-mL Phillips beaker along 
with any loose dust found in the cassette. Label each Phillips beaker 
with the appropriate sample number.
    3.9.2. Digest the sample by adding 5 mL of concentrated nitric acid 
(HNO3) to each Phillips beaker containing an air filter 
sample. Place the Phillips beakers on a hot plate in an exhaust hood and 
heat the samples until approximately 0.5 mL remains. The sample

[[Page 176]]

solution in each Phillips beaker should become clear. If it is not 
clear, digest the sample with another portion of concentrated nitric 
acid.
    3.9.3. After completing the HNO3 digestion and cooling 
the samples, add 40 [micro]L (2 drops) of concentrated HCl to each air 
sample solution and then swirl the contents. Carefully add about 5 mL of 
deionized water by pouring it down the inside of each beaker.
    3.9.4. Quantitatively transfer each cooled air sample solution from 
each Phillips beaker to a clean 10-mL volumetric flask. Dilute each 
flask to volume with deionized water and mix well.

                        3.10. Flame AAS Analysis

    Analyze all of the air samples for their cadmium content by flame 
atomic absorption spectroscopy (AAS) according to the instructions given 
below.
    3.10.1. Set up the atomic absorption spectrophotometer for the air/
acetylene flame analysis of cadmium according to the SOP (5.8.) or the 
manufacturer's operational instructions. For the source lamp, use the 
cadmium hollow cathode or electrodeless discharge lamp operated at the 
manufacturer's recommended rating for continuous operation. Allow the 
lamp to warm up 10 to 20 min or until the energy output stabilizes. 
Optimize conditions such as lamp position, burner head alignment, fuel 
and oxidant flow rates, etc. See the SOP or specific instrument manuals 
for details. Instrumental parameters for the Perkin-Elmer Model 603 used 
in the validation of this method are given in Attachment 1.
    3.10.2. Aspirate and measure the absorbance of a standard solution 
of cadmium. The standard concentration should be within the linear 
range. For the instrumentation used in the validation of this method a 2 
[micro]g/mL cadmium standard gives a net absorbance reading of about 
0.350 abs. units (see Section 1.5.5.) when the instrument and the source 
lamp are performing to manufacturer specifications.
    3.10.3. To increase instrument response, scale expand the absorbance 
reading of the aspirated 2 [micro]g/mL working standard approximately 
four times. Increase the integration time to at least 3 seconds to 
reduce signal noise.
    3.10.4. Autozero the instrument while aspirating a deionized water 
blank. Monitor the variation in the baseline absorbance reading 
(baseline noise) for a few minutes to insure that the instrument, source 
lamp and associated equipment are in good operating condition.
    3.10.5. Aspirate the working standards and samples directly into the 
flame and record their absorbance readings. Aspirate the deionized water 
blank immediately after every standard or sample to correct for and 
monitor any baseline drift and noise. Record the baseline absorbance 
reading of each deionized water blank. Label each standard and sample 
reading and its accompanying baseline reading.
    3.10.6. It is recommended that the entire series of working 
standards be analyzed at the beginning and end of the analysis of a set 
of samples to establish a concentration-response curve, ensure that the 
standard readings agree with each other and are reproducible. Also, 
analyze a working standard after every five or six samples to monitor 
the performance of the spectrophotometer. Standard readings should agree 
within 10 to 15% of the readings obtained at the 
beginning of the analysis.
    3.10.7. Bracket the sample readings with standards during the 
analysis. If the absorbance reading of a sample is above the absorbance 
reading of the highest working standard, dilute the sample with diluting 
solution and reanalyze. Use the appropriate dilution factor in the 
calculations.
    3.10.8. Repeat the analysis of approximately 10% of the samples for 
a check of precision.
    3.10.9. If possible, analyze quality control samples from an 
independent source as a check on analytical recovery and precision.
    3.10.10. Record the final instrument settings at the end of the 
analysis. Date and label the output.

                         3.11. AAS-HGA Analysis

    Initially analyze all of the air samples for their cadmium content 
by flame atomic absorption spectroscopy (AAS) according to the 
instructions given in Section 3.10. If the concentration of cadmium in a 
sample solution is less than three times the quantitative detection 
limit [0.04 [micro]g/mL (40 ng/mL) for the instrumentation used in the 
validation] and the sample results are to be averaged with other samples 
for TWA calculations, proceed with the AAS-HGA analysis of the sample as 
described below.
    3.11.1. Set up the atomic absorption spectrophotometer and HGA for 
flameless atomic absorption analysis of cadmium according to the SOP 
(5.9.) or the manufacturer's operational instructions and allow the 
instrument to stabilize. The graphite furnace atomizer is equipped with 
a pyrolytically coated graphite tube containing a pyrolytic platform. 
For the source lamp, use a cadmium hollow cathode or electrodeless 
discharge lamp operated at the manufacturer's recommended setting for 
graphite furnace operation. The Zeeman background corrector and EDL are 
recommended for use with the L'vov platform. Instrumental parameters for 
the Perkin-Elmer Model 5100 spectrophotometer and Zeeman HGA-600 
graphite furnace used in the validation of this method are given in 
Attachment 2.
    3.11.2. Optimize the energy reading of the spectrophotometer at 
228.8 nm by adjusting

[[Page 177]]

the lamp position and the wavelength according to the manufacturer's 
instructions.
    3.11.3. Set up the autosampler to inject a 5-[micro]L aliquot of the 
working standard, sample or reagent blank solution onto the L'vov 
platform along with a 10-[micro]L overlay of the matrix modifier.
    3.11.4. Analyze the reagent blank (diluting solution, Section 
3.5.6.) and then autozero the instrument before starting the analysis of 
a set of samples. It is recommended that the reagent blank be analyzed 
several times during the analysis to assure the integrated absorbance 
(peak area) reading remains at or near zero.
    3.11.5. Analyze a working standard approximately midway in the 
linear portion of the working standard range two or three times to check 
for reproducibility and sensitivity (see sections 1.5.5. and 1.5.6.) 
before starting the analysis of samples. Calculate the experimental 
characteristic mass value from the average integrated absorbance reading 
and injection volume of the analyzed working standard. Compare this 
value to the manufacturer's suggested value as a check of proper 
instrument operation.
    3.11.6. Analyze the reagent blank, working standard, and sample 
solutions. Record and label the peak area (abs-sec) readings and the 
peak and background peak profiles on the printer/plotter.
    3.11.7. It is recommended the entire series of working standards be 
analyzed at the beginning and end of the analysis of a set of samples. 
Establish a concentration-response curve and ensure standard readings 
agree with each other and are reproducible. Also, analyze a working 
standard after every five or six samples to monitor the performance of 
the system. Standard readings should agree within 15% of the readings obtained at the beginning of the 
analysis.
    3.11.8. Bracket the sample readings with standards during the 
analysis. If the peak area reading of a sample is above the peak area 
reading of the highest working standard, dilute the sample with the 
diluting solution and reanalyze. Use the appropriate dilution factor in 
the calculations.
    3.11.9. Repeat the analysis of approximately 10% of the samples for 
a check of precision.
    3.11.10. If possible, analyze quality control samples from an 
independent source as a check of analytical recovery and precision.
    3.11.11. Record the final instrument settings at the end of the 
analysis. Date and label the output.

                           3.12. Calculations

    Note: Standards used for HGA analysis are in ng/mL. Total amounts of 
cadmium from calculations will be in ng (not [micro]g) unless a prior 
conversion is made.

    3.12.1. Correct for baseline drift and noise in flame AAS analysis 
by subtracting each baseline absorbance reading from its corresponding 
working standard or sample absorbance reading to obtain the net 
absorbance reading for each standard and sample.
    3.12.2. Use a least squares regression program to plot a 
concentration-response curve of net absorbance reading (or peak area for 
HGA analysis) versus concentration ([micro]g/mL or ng/mL) of cadmium in 
each working standard.
    3.12.3. Determine the concentration ([micro]g/mL or ng/mL) of 
cadmium in each sample from the resulting concentration-response curve. 
If the concentration of cadmium in a sample solution is less than three 
times the quantitative detection limit [0.04 [micro]g/mL (40 ng/mL) for 
the instrumentation used in the validation of the method] and if 
consecutive samples were taken on one employee and the sample results 
are to be averaged with other samples to determine a single TWA, 
reanalyze the sample by AAS-HGA as described in Section 3.11. and report 
the AAS-HGA analytical results.
    3.12.4. Calculate the total amount ([micro]g or ng) of cadmium in 
each sample from the sample solution volume (mL):
W = (C)(sample vol, mL)(DF)

Where:

W = Total cadmium in sample
C = Calculated concentration of cadmium
DF = Dilution Factor (if applicable)

    3.12.5. Make a blank correction for each air sample by subtracting 
the total amount of cadmium in the corresponding blank sample from the 
total amount of cadmium in the sample.
    3.12.6. Calculate the concentration of cadmium in an air sample (mg/
m\3\ or [micro]g/m\3\) by using one of the following equations:

mg/m\3\ = Wbc/(Air vol sampled, L)

or

[micro]g/m\3\ = (Wbc)(1,000 ng/[micro]g)/(Air vol sampled, L)

Where:

Wbc = blank corrected total [micro]g cadmium in the sample. 
(1[micro]g=1,000 ng)

                             4. Backup Data

                            4.1. Introduction

    4.1.1. The purpose of this evaluation is to determine the analytical 
method recovery, working standard range, and qualitative and 
quantitative detection limits of the two atomic absorption analytical 
techniques included in this method. The evaluation consisted of the 
following experiments:
    1. An analysis of 24 samples (six samples each at 0.1, 0.5, 1 and 2 
times the TWA-PEL) for the analytical method recovery study of the flame 
AAS analytical technique.
    2. An analysis of 18 samples (six samples each at 0.5, 1 and 2 times 
the Action Level

[[Page 178]]

TWA-PEL) for the analytical method recovery study of the AAS-HGA 
analytical technique.
    3. Multiple analyses of the reagent blank and a series of standard 
solutions to determine the working standard range and the qualitative 
and quantitative detection limits for both atomic absorption analytical 
techniques.
    4.1.2. The analytical method recovery results at all test levels 
were calculated from concentration-response curves and statistically 
examined for outliers at the 99% confidence level. Possible outliers 
were determined using the Treatment of Outliers test (5.10.). In 
addition, the sample results of the two analytical techniques, at 0.5, 
1.0 and 2.0 times their target concentrations, were tested for 
homogeneity of variances also at the 99% confidence level. Homogeneity 
of the coefficients of variation was determined using the Bartlett's 
test (5.11.). The overall analytical error (OAE) at the 95% confidence 
level was calculated using the equation (5.12.):

OAE = [[verbar] 
Bias[verbar]+(1.96)(CV1(pooled))(100%)]

    4.1.3. A derivation of the International Union of Pure and Applied 
Chemistry (IUPAC) detection limit equation (5.13.) was used to determine 
the qualitative and quantitative detection limits for both atomic 
absorption analytical techniques:

Cld = k(sd)/m (Equation 1)

Where:

Cld = the smallest reliable detectable concentration an 
analytical instrument can determine at a given confidence level.
k = 3 for the Qualitative Detection Limit at the 99.86% Confidence Level
= 10 for the Quantitative Detection Limit at the 99.99% Confidence 
Level.
sd = standard deviation of the reagent blank (Rbl) readings.
m = analytical sensitivity or slope as calculated by linear regression.

    4.1.4. Collection efficiencies of metallic fume and dust atmospheres 
on 0.8-[micro]m mixed cellulose ester membrane filters are well 
documented and have been shown to be excellent (5.11.). Since elemental 
cadmium and the cadmium component of cadmium compounds are nonvolatile, 
stability studies of cadmium spiked MCEF samples were not performed.

                             4.2. Equipment

    4.2.1. A Perkin-Elmer (PE) Model 603 spectrophotometer equipped with 
a manual gas control system, a stainless steel nebulizer, a burner 
mixing chamber, a flow spoiler and a 10 cm. (one-slot) burner head was 
used in the experimental validation of the flame AAS analytical 
technique. A PE cadmium hollow cathode lamp, operated at the 
manufacturer's recommended current setting for continuous operation (4 
mA), was used as the source lamp. Instrument parameters are listed in 
Attachment 1.
    4.2.2. A PE Model 5100 spectrophotometer, Zeeman HGA-600 graphite 
furnace atomizer and AS-60 HGA autosampler were used in the experimental 
validation of the AAS-HGA analytical technique. The spectrophotometer 
was equipped with a PE Series 7700 professional computer and Model PR-
310 printer. A PE System 2 cadmium electrodeless discharge lamp, 
operated at the manufacturer's recommended current setting for modulated 
operation (170 mA), was used as the source lamp. Instrument parameters 
are listed in Attachment 2.

                              4.3. Reagents

    4.3.1. J.T. Baker Chem. Co. (Analyzed grade) concentrated nitric 
acid, 69.0-71.0%, and concentrated hydrochloric acid, 36.5-38.0%, were 
used to prepare the samples and standards.
    4.3.2. Ammonium phosphate, monobasic, NH4 H2 
PO4 and magnesium nitrate, 
Mg(NO3)26H2 O, both manufactured by the 
Mallinckrodt Chem. Co., were used to prepare the matrix modifier for 
AAS-HGA analysis.

            4.4. Standard Preparation for Flame AAS Analysis

    4.4.1. Dilute stock solutions: Prepared 0.01, 0.1, 1, 10 and 100 
[micro]g/mL cadmium standard stock solutions by making appropriate 
serial dilutions of a commercially available 1,000 [micro]g/mL cadmium 
standard stock solution (RICCA Chemical Co., Lot A102) with the 
diluting solution (4% HNO3, 0.4% HCl).
    4.4.2. Analyzed Standards: Prepared cadmium standards in the range 
of 0.001 to 2.0 [micro]g/mL by pipetting 2 to 10 mL of the appropriate 
dilute cadmium stock solution into a 100-mL volumetric flask and 
diluting to volume with the diluting solution. (See Section 3.7.2.)

             4.5. Standard Preparation for AAS-HGA Analysis

    4.5.1. Dilute stock solutions: Prepared 1, 10, 100 and 1,000 ng/mL 
cadmium standard stock solutions by making appropriate serial dilutions 
of a commercially available 1,000 [micro]g/mL cadmium standard stock 
solution (J.T. Baker Chemical Co., Instra-analyzed, Lot D22642) 
with the diluting solution (4% HNO3, 0.4% HCl).
    4.5.2. Analyzed Standards: Prepared cadmium standards in the range 
of 0.1 to 40 ng/mL by pipetting 2 to 10 mL of the appropriate dilute 
cadmium stock solution into a 100-mL volumetric flask and diluting to 
volume with the diluting solution. (See Section 3.8.2.)

[[Page 179]]

 4.6. Detection Limits and Standard Working Range for Flame AAS Analysis

    4.6.1. Analyzed the reagent blank solution and the entire series of 
cadmium standards in the range of 0.001 to 2.0 [micro]g/mL three to six 
times according to the instructions given in Section 3.10. The diluting 
solution (4% HNO3, 0.4% HCl) was used as the reagent blank. 
The integration time on the PE 603 spectrophotometer was set to 3.0 
seconds and a four-fold expansion of the absorbance reading of the 2.0 
[micro]g/mL cadmium standard was made prior to analysis. The 2.0 
[micro]g/mL standard gave a net absorbance reading of 0.350 abs. units 
prior to expansion in agreement with the manufacturer's specifications 
(5.6.).
    4.6.2. The net absorbance readings of the reagent blank and the low 
concentration Cd standards from 0.001 to 0.1 [micro]g/mL and the 
statistical analysis of the results are shown in Table I. The standard 
deviation, sd, of the six net absorbance readings of the reagent blank 
is 1.05 abs. units. The slope, m, as calculated by a linear regression 
plot of the net absorbance readings (shown in Table II) of the 0.02 to 
1.0 [micro]g/mL cadmium standards versus their concentration is 772.7 
abs. units/([micro]g/mL).
    4.6.3. If these values for sd and the slope, m, are used in Eqn. 1 
(Sect. 4.1.3.), the qualitative and quantitative detection limits as 
determined by the IUPAC Method are:

Cld=(3)(1.05 abs. units)/(772.7 abs. units/([micro]g/mL))
    = 0.0041 [micro]g/mL for the qualitative detection limit.
Cld=(10)(1.05 abs. units)/(772.7 abs. units/[micro]g/mL))
    =0.014 [micro]g/mL for the quantitative detection limit.

The qualitative and quantitative detection limits for the flame AAS 
analytical technique are 0.041 [micro]g and 0.14 [micro]g cadmium, 
respectively, for a 10 mL solution volume. These correspond, 
respectively, to 0.2 [micro]g/m\3\ and 0.70 [micro]g/m\3\ for a 200 L 
air volume.
    4.6.4. The recommended Cd standard working range for flame AAS 
analysis is 0.02 to 2.0 [micro]g/mL. The net absorbance readings of the 
reagent blank and the recommended working range standards and the 
statistical analysis of the results are shown in Table II. The standard 
of lowest concentration in the working range, 0.02 [micro]g/mL, is 
slightly greater than the calculated quantitative detection limit, 0.014 
[micro]g/mL. The standard of highest concentration in the working range, 
2.0 [micro]g/mL, is at the upper end of the linear working range 
suggested by the manufacturer (5.6.). Although the standard net 
absorbance readings are not strictly linear at concentrations above 0.5 
[micro]g/mL, the deviation from linearity is only about 10% at the upper 
end of the recommended standard working range. The deviation from 
linearity is probably caused by the four-fold expansion of the signal 
suggested in the method. As shown in Table II, the precision of the 
standard net absorbance readings are excellent throughout the 
recommended working range; the relative standard deviations of the 
readings range from 0.009 to 0.064.

  4.7. Detection Limits and Standard Working Range for AAS-HGA Analysis

    4.7.1. Analyzed the reagent blank solution and the entire series of 
cadmium standards in the range of 0.1 to 40 ng/mL according to the 
instructions given in Section 3.11. The diluting solution (4% 
HNO3, 0.4% HCl) was used as the reagent blank. A fresh 
aliquot of the reagent blank and of each standard was used for every 
analysis. The experimental characteristic mass value was 0.41 pg, 
calculated from the average peak area (abs-sec) reading of the 5 ng/mL 
standard which is approximately midway in the linear portion of the 
working standard range. This agreed within 20% with the characteristic 
mass value, 0.35 pg, listed by the manufacturer of the instrument 
(5.2.).
    4.7.2. The peak area (abs-sec) readings of the reagent blank and the 
low concentration Cd standards from 0.1 to 2.0 ng/mL and statistical 
analysis of the results are shown in Table III. Five of the reagent 
blank peak area readings were zero and the sixth reading was 1 and was 
an outlier. The near lack of a blank signal does not satisfy a strict 
interpretation of the IUPAC method for determining the detection limits. 
Therefore, the standard deviation of the six peak area readings of the 
0.2 ng/mL cadmium standard, 0.75 abs-sec, was used to calculate the 
detection limits by the IUPAC method. The slope, m, as calculated by a 
linear regression plot of the peak area (abs-sec) readings (shown in 
Table IV) of the 0.2 to 10 ng/mL cadmium standards versus their 
concentration is 51.5 abs-sec/(ng/mL).
    4.7.3. If 0.75 abs-sec (sd) and 51.5 abs-sec/(ng/mL) (m) are used in 
Eqn. 1 (Sect. 4.1.3.), the qualitative and quantitative detection limits 
as determined by the IUPAC method are:

Cld = (3)(0.75 abs-sec)/(51.5 abs-sec/(ng/mL)
    = 0.044 ng/mL for the qualitative detection limit.

Cld= (10)(0.75 abs-sec)/(51.5 abs-sec/(ng/mL) = 0.15 ng/mL 
for the quantitative detection limit.
The qualitative and quantitative detection limits for the AAS-HGA 
analytical technique are 0.44 ng and 1.5 ng cadmium, respectively, for a 
10 mL solution volume. These correspond, respectively, to 0.007 
[micro]g/m\3\ and 0.025 [micro]g/m\3\ for a 60 L air volume.
    4.7.4. The peak area (abs-sec) readings of the Cd standards from 0.2 
to 40 ng/mL and the statistical analysis of the results are given in 
Table IV. The recommended standard working range for AAS-HGA analysis is

[[Page 180]]

0.2 to 20 ng/mL. The standard of lowest concentration in the recommended 
working range is slightly greater than the calculated quantitative 
detection limit, 0.15 ng/mL. The deviation from linearity of the peak 
area readings of the 20 ng/mL standard, the highest concentration 
standard in the recommended working range, is approximately 10%. The 
deviations from linearity of the peak area readings of the 30 and 40 ng/
mL standards are significantly greater than 10%. As shown in Table IV, 
the precision of the peak area readings are satisfactory throughout the 
recommended working range; the relative standard deviations of the 
readings range from 0.025 to 0.083.

         4.8. Analytical Method Recovery for Flame AAS Analysis

    4.8.1. Four sets of spiked MCEF samples were prepared by injecting 
20 [micro]L of 10, 50, 100 and 200 [micro]g/mL dilute cadmium stock 
solutions on 37 mm diameter filters (part no. AAWP 037 00, Millipore 
Corp., Bedford, MA) with a calibrated micropipet. The dilute stock 
solutions were prepared by making appropriate serial dilutions of a 
commercially available 1,000 [micro]g/mL cadmium standard stock solution 
(RICCA Chemical Co., Lot A102) with the diluting solution (4% 
HNO3, 0.4% HCl). Each set contained six samples and a sample 
blank. The amount of cadmium in the prepared sets were equivalent to 
0.1, 0.5, 1.0 and 2.0 times the TWA PEL target concentration of 5 
[micro]g/m\3\ for a 400 L air volume.
    4.8.2. The air-dried spiked filters were digested and analyzed for 
their cadmium content by flame atomic absorption spectroscopy (AAS) 
following the procedure described in Section 3. The 0.02 to 2.0[micro]g/
mL cadmium standards (the suggested working range) were used in the 
analysis of the spiked filters.
    4.8.3. The results of the analysis are given in Table V. One result 
at 0.5 times the TWA PEL target concentration was an outlier and was 
excluded from statistical analysis. Experimental justification for 
rejecting it is that the outlier value was probably due to a spiking 
error. The coefficients of variation for the three test levels at 0.5 to 
2.0 times the TWA PEL target concentration passed the Bartlett's test 
and were pooled.
    4.8.4. The average recovery of the six spiked filter samples at 0.1 
times the TWA PEL target concentration was 118.2% with a coefficient of 
variation (CV1) of 0.128. The average recovery of the spiked 
filter samples in the range of 0.5 to 2.0 times the TWA target 
concentration was 104.0% with a pooled coefficient of variation 
(CV1) of 0.010. Consequently, the analytical bias found in 
these spiked sample results over the tested concentration range was 
+4.0% and the OAE was 6.0%.

          4.9. Analytical Method Recovery for AAS-HGA Analysis

    4.9.1. Three sets of spiked MCEF samples were prepared by injecting 
15[micro]L of 5, 10 and 20 [micro]g/mL dilute cadmium stock solutions on 
37 mm diameter filters (part no. AAWP 037 00, Millipore Corp., Bedford, 
MA) with a calibrated micropipet. The dilute stock solutions were 
prepared by making appropriate serial dilutions of a commercially 
available certified 1,000 [micro]g/mL cadmium standard stock solution 
(Fisher Chemical Co., Lot 913438-24) with the diluting solution 
(4% HNO3, 0.4% HCl). Each set contained six samples and a 
sample blank. The amount of cadmium in the prepared sets were equivalent 
to 0.5, 1 and 2 times the Action Level TWA target concentration of 2.5 
[micro]g/m\3\ for a 60 L air volume.
    4.9.2. The air-dried spiked filters were digested and analyzed for 
their cadmium content by flameless atomic absorption spectroscopy using 
a heated graphite furnace atomizer following the procedure described in 
Section 3. A five-fold dilution of the spiked filter samples at 2 times 
the Action Level TWA was made prior to their analysis. The 0.05 to 20 
ng/mL cadmium standards were used in the analysis of the spiked filters.
    4.9.3. The results of the analysis are given in Table VI. There were 
no outliers. The coefficients of variation for the three test levels at 
0.5 to 2.0 times the Action Level TWA PEL passed the Bartlett's test and 
were pooled. The average recovery of the spiked filter samples was 94.2% 
with a pooled coefficient of variation (CV1) of 0.043. 
Consequently, the analytical bias was -5.8% and the OAE was 14.2%.

                            4.10. Conclusions

    The experiments performed in this evaluation show the two atomic 
absorption analytical techniques included in this method to be precise 
and accurate and have sufficient sensitivity to measure airborne cadmium 
over a broad range of exposure levels and sampling periods.

                              5. References

    5.1. Slavin, W. Graphite Furnace AAS--A Source Book; Perkin-Elmer 
Corp., Spectroscopy Div.: Ridgefield, CT, 1984; p. 18 and pp. 83-90.
    5.2. Grosser, Z., Ed.; Techniques in Graphite Furnace Atomic 
Absorption Spectrophotometry; Perkin-Elmer Corp., Spectroscopy Div.: 
Ridgefield, CT, 1985.
    5.3. Occupational Safety and Health Administration Salt Lake 
Technical Center: Metal and Metalloid Particulate in Workplace 
Atmospheres (Atomic Absorption) (USDOL/OSHA Method No. ID-121). In OSHA 
Analytical Methods Manual 2nd ed. Cincinnati, OH: American Conference of 
Governmental Industrial Hygienists, 1991.

[[Page 181]]

    5.4. Occupational Safety and Health Administration Salt Lake 
Technical Center: Metal and Metalloid Particulate in Workplace 
Atmospheres (ICP) (USDOL/OSHA Method No. ID-125G). In OSHA Analytical 
Methods Manual 2nd ed. Cincinnati, OH: American Conference of 
Governmental Industrial Hygienists, 1991.
    5.5. Windholz, M., Ed.; The Merck Index, 10th ed.; Merck & Co.: 
Rahway, NJ, 1983.
    5.6. Analytical Methods for Atomic Absorption Spectrophotometry, The 
Perkin-Elmer Corporation: Norwalk, CT, 1982.
    5.7. Slavin, W., D.C. Manning, G. Carnrick, and E. Pruszkowska: 
Properties of the Cadmium Determination with the Platform Furnace and 
Zeeman Background Correction. Spectrochim. Acta 38B:1157-1170 (1983).
    5.8. Occupational Safety and Health Administration Salt Lake 
Technical Center: Standard Operating Procedure for Atomic Absorption. 
Salt Lake City, UT: USDOL/OSHA-SLTC, In progress.
    5.9. Occupational Safety and Health Administration Salt Lake 
Technical Center: AAS-HGA Standard Operating Procedure. Salt Lake City, 
UT: USDOL/OSHA-SLTC, In progress.
    5.10. Mandel, J.: Accuracy and Precision, Evaluation and 
Interpretation of Analytical Results, The Treatment of Outliers. In 
Treatise On Analytical Chemistry, 2nd ed., Vol.1, edited by I. M. 
Kolthoff and P. J. Elving. New York: John Wiley and Sons, 1978. pp. 282-
285.
    5.11. National Institute for Occupational Safety and Health: 
Documentation of the NIOSH Validation Tests by D. Taylor, R. Kupel, and 
J. Bryant (DHEW/NIOSH Pub. No. 77-185). Cincinnati, OH: National 
Institute for Occupational Safety and Health, 1977.
    5.12. Occupational Safety and Health Administration Analytical 
Laboratory: Precision and Accuracy Data Protocol for Laboratory 
Validations. In OSHA Analytical Methods Manual 1st ed. Cincinnati, OH: 
American Conference of Governmental Industrial Hygienists (Pub. No. 
ISBN: 0-936712-66-X), 1985.
    5.13. Long, G.L. and J.D. Winefordner: Limit of Detection--A Closer 
Look at the IUPAC Definition. Anal.Chem. 55:712A-724A (1983).
    5.14. American Conference of Governmental Industrial Hygienists: 
Documentation of Threshold Limit Values and Biological Exposure Indices. 
5th ed. Cincinnati, OH: American Conference of Governmental Industrial 
Hygienists, 1986.

                    Table I--Cd Detection Limit Study
                          [Flame AAS Analysis]
------------------------------------------------------------------------
                                      Absorbance
        STD ([micro]g/mL)          reading at 228.8      Statistical
                                          nm               analysis
------------------------------------------------------------------------
Reagent blank...................                5 2  n=6.
                                                4 3  mean=3.50.
                                                4 3  std dev=1.05.
                                                     CV=0.30.
0.001...........................                6 6  n=6.
                                                2 4  mean=5.00.
                                                6 6  std dev=1.67.
                                                     CV=0.335.
0.002...........................                5 7  n=6.
                                                7 3  mean=5.50.
                                                7 4  std dev=1.76.
                                                     CV=0.320.
0.005...........................                7 7  n=6.
                                                8 8  mean=7.33.
                                                8 6  std dev=0.817.
                                                     CV=0.111.
0.010...........................               10 9  n=6.
                                              10 13  mean=10.3.
                                              10 10  std dev=1.37.
                                                     CV=0.133.
0.020...........................              20 23  n=6.
                                              20 22  mean=20.8.
                                              20 20  std dev=1.33.
                                                     CV=0.064.
0.050...........................              42 42  n=6.
                                              42 42  mean=42.5.
                                              42 45  std dev=1.22.
                                                     CV=0.029.
0.10............................                 84  n=3.
                                                 80  mean=82.3.
                                                 83  std dev=2.08.
                                                     CV=0.025.
------------------------------------------------------------------------


                Table II--Cd Standard Working Range Study
                          [Flame AAS Analysis]
------------------------------------------------------------------------
                                      Absorbance
        STD ([micro]g/mL)          reading at 228.8      Statistical
                                          nm               analysis
------------------------------------------------------------------------
Reagent blank...................                5 2  n=6.
                                                4 3  mean=3.50.
                                                4 3  std dev=1.05.
                                                     CV=0.30.
0.020...........................              20 23  n=6.
                                              20 22  mean=20.8.
                                              20 20  std dev=1.33.
                                                     CV=0.064.
0.050...........................              42 42  n=6.
                                              42 42  mean=42.5.
                                              42 45  std dev=1.22.
                                                     CV=0.029.
0.10............................                 84  n=3.
                                                 80  mean=82.3.
                                                 83  std dev=2.08.
                                                     CV=0.025.
0.20............................                161  n=3.
                                                161  mean=160.0.
                                                158  std dev=1.73.
                                                     CV=0.011.
0.50............................                391  n=3.
                                                389  mean=391.0.
                                                393  std dev=2.00.
                                                     CV=0.005.
1.00............................                760  n=3.
                                                748  mean=753.3.
                                                752  std dev=6.11.
                                                     CV=0.008.

[[Page 182]]

 
2.00............................               1416  n=3.
                                               1426  mean=1414.3.
                                               1401  std dev=12.6.
                                                     CV=0.009.
------------------------------------------------------------------------


                   Table III--Cd Detection Limit Study
                           [AAS-HGA Analysis]
------------------------------------------------------------------------
                                      Peak area
                                      readings x
            STD (ng/mL)                10\3\ at    Statistical analysis
                                       228.8 nm
------------------------------------------------------------------------
Reagent blank......................          0 0  n=6.
                                             0 1  mean=0.167.
                                             0 0  std dev=0.41.
                                                  CV=2.45.
0.1................................          8 6  n=6.
                                             5 7  mean=7.7.
                                            13 7  std dev=2.8.
                                                  CV=0.366.
0.2................................        11 13  n=6.
                                           11 12  mean=11.8.
                                           12 12  std dev=0.75.
                                                  CV=0.064.
0.5................................        28 33  n=6.
                                           26 28  mean=28.8.
                                           28 30  std dev=2.4.
                                                  CV=0.083.
1.0................................        52 55  n=6.
                                           56 58  mean=54.8.
                                           54 54  std dev=2.0.
                                                  CV=0.037.
2.0................................      101 112  n=6.
                                         110 110  mean=108.8.
                                         110 110  std dev=3.9.
                                                  CV=0.036.
------------------------------------------------------------------------


                Table IV--Cd Standard Working Range Study
                           [AAS-HGA Analysis]
------------------------------------------------------------------------
                                      Peak area
                                      readings x
            STD (ng/mL)                10\3\ at    Statistical analysis
                                       228.8 nm
------------------------------------------------------------------------
0.2................................        11 13  n=6.
                                           11 12  mean=11.8.
                                           12 12  std dev=0.75.
                                                  CV=0.064.
0.5................................        28 33  n=6.
                                           26 28  mean=28.8.
                                           28 30  std dev=2.4.
                                                  CV=0.083.
1.0................................        52 55  n=6.
                                           56 58  mean=54.8.
                                           54 54  std dev=2.0.
                                                  CV=0.037.
2.0................................      101 112  n=6.
                                         110 110  mean=108.8.
                                         110 110  std dev=3.9.
                                                  CV=0.036.
5.0................................      247 265  n=6.
                                         268 275  mean=265.5.
                                         259 279  std dev=11.5.
                                                  CV=0.044.
10.0...............................      495 520  n=6.
                                         523 513  mean=516.7.
                                         516 533  std dev=12.7.
                                                  CV=0.025.
20.0...............................      950 953  n=6.
                                         951 958  mean=941.8.
                                         949 890  std dev=25.6.
                                                  CV=0.027.
30.0...............................    1269 1291  n=6.
                                       1303 1307  mean=1293.
                                       1295 1290  std dev=13.3.
                                                  CV=0.010.
40.0...............................    1505 1567  n=6.
                                       1535 1567  mean=1552.
                                       1566 1572  std dev=26.6.
                                                  CV=0.017.
------------------------------------------------------------------------


                                       Table V--Analytical Method Recovery
                                              [Flame AAS Analysis]
----------------------------------------------------------------------------------------------------------------
         Test level             0.5x                           1.0x                           2.0x
---------------------------------------  Percent   [micro]g ----------  Percent   [micro]g ----------   Percent
                              [micro]g     rec.      taken   [micro]g     rec.      taken   [micro]g     rec.
       [micro]g taken           found                          found                          found
----------------------------------------------------------------------------------------------------------------
1.00........................    1.0715    107.2        2.00    2.0688    103.4        4.00    4.1504     103.8
1.00........................    1.0842    108.4        2.00    2.0174    100.9        4.00    4.1108     102.8
1.00........................    1.0842    108.4        2.00    2.0431    102.2        4.00    4.0581     101.5
1.00........................   *1.0081   *100.8        2.00    2.0431    102.2        4.00    4.0844     102.1
1.00........................    1.0715    107.2        2.00    2.0174    100.9        4.00    4.1504     103.8
1.00........................    1.0842    108.4        2.00    2.0045    100.2        4.00    4.1899     104.7
----------------------------------------------------------------------------------------------------------------


n=                             ........      5      ........  ........      6      ........  ........      6
mean=                          ........    107.9    ........  ........    101.6    ........  ........    103.1
std dev=                       ........      0.657  ........  ........      1.174  ........  ........      1.199
CV1=                           ........      0.006  ........  ........      0.011  ........  ........      0.012
                                               CV1 (pooled)=0.010
* Rejected as an outlier--this value did not pass the outlier T-test at the 99% confidence level.


------------------------------------------------------------------------
             Test level                      0.1x
--------------------------------------------------------   Percent rec.
           [micro]g taken               [micro]g found
------------------------------------------------------------------------
0.200...............................             0.2509          125.5
0.200...............................             0.2509          125.5
0.200...............................             0.2761          138.1

[[Page 183]]

 
0.200...............................             0.2258          112.9
0.200...............................             0.2258          112.9
0.200...............................             0.1881           94.1
------------------------------------------------------------------------


n=..................................  .................            6
mean=...............................  .................          118.2
std dev=............................  .................           15.1
CV1=................................  .................            0.128


                                      Table VI--Analytical Method Recovery
                                               [AAS-HGA analysis]
----------------------------------------------------------------------------------------------------------------
             Test level                 0.5x                       1.0x                        2.0x
----------------------------------------------  Percent     ng  ----------  Percent     ng  ----------  Percent
                                         ng       rec.    taken               rec.    taken               rec.
              ng taken                 found                     ng found                    ng found
----------------------------------------------------------------------------------------------------------------
75..................................    71.23     95.0      150    138.00     92.0      300    258.43     86.1
75..................................    71.47     95.3      150    138.29     92.2      300    258.46     86.2
75..................................    70.02     93.4      150    136.30     90.9      300    280.55     93.5
75..................................    77.34    103.1      150    146.62     97.7      300    288.34     96.1
75..................................    78.32    104.4      150    145.17     96.8      300    261.74     87.2
75..................................    71.96     95.9      150    144.88     96.6      300    277.22     92.4
----------------------------------------------------------------------------------------------------------------


n=                             ........      6      ........  ........      6      ........  ........      6
mean=                          ........     97.9    ........  ........     94.4    ........  ........     90.3
std dev=                       ........      4.66   ........  ........      2.98   ........  ........      4.30
CV1=                           ........      0.048  ........  ........      0.032  ........  ........      0.048
                                                CV1(pooled)=0.043

                              Attachment 1

             Instrumental Parameters for Flame AAS Analysis

      Atomic Absorption Spectrophotometer (Perkin-Elmer Model 603)

Flame: Air/Acetylene--lean, blue
Oxidant Flow: 55
Fuel Flow: 32
Wavelength: 228.8 nm
Slit: 4 (0.7 nm)
Range: UV
Signal: Concentration (4 exp)
Integration Time: 3 sec

                              Attachment 2

                Instrumental Parameters for HGA Analysis

      Atomic Absorption Spectrophotometer (Perkin-Elmer Model 5100)

Signal Type: Zeeman AA
Slitwidth: 0.7 nm
Wavelength: 228.8 nm
Measurement: Peak Area
Integration Time: 6.0 sec
BOC Time: 5 sec
    BOC=Background Offset Correction.

                              Zeeman Graphite Furnace (Perkin-Elmer Model HGA-600)
----------------------------------------------------------------------------------------------------------------
                                                       Ramp time   Hold time    Temp. (   Argon flow
                        Step                             (sec)       (sec)      [deg]C)    (mL/min)   Read (sec)
----------------------------------------------------------------------------------------------------------------
1) Predry...........................................           5          10          90         300
2) Dry..............................................          30          10         140         300
3) Char.............................................          10          20         900         300
4) Cool Down........................................           1           8          30         300
5) Atomize..........................................           0           5        1600           0          -1
6) Burnout..........................................           1           8        2500         300  ..........
----------------------------------------------------------------------------------------------------------------


[[Page 184]]

  Appendix F to Sec. 1910.1027--Nonmandatory Protocol for Biological 
                               Monitoring

                            1.00 Introduction

    Under the final OSHA cadmium rule (29 CFR part 1910), monitoring of 
biological specimens and several periodic medical examinations are 
required for eligible employees. These medical examinations are to be 
conducted regularly, and medical monitoring is to include the periodic 
analysis of cadmium in blood (CDB), cadmium in urine (CDU) and beta-2-
microglobulin in urine (B2MU). As CDU and B2MU are to be normalized to 
the concentration of creatinine in urine (CRTU), then CRTU must be 
analyzed in conjunction with CDU and B2MU analyses.
    The purpose of this protocol is to provide procedures for 
establishing and maintaining the quality of the results obtained from 
the analyses of CDB, CDU and B2MU by commercial laboratories. 
Laboratories conforming to the provisions of this nonmandatory protocol 
shall be known as ``participating laboratories.'' The biological 
monitoring data from these laboratories will be evaluated by physicians 
responsible for biological monitoring to determine the conditions under 
which employees may continue to work in locations exhibiting airborne-
cadmium concentrations at or above defined actions levels (see 
paragraphs (l)(3) and (l)(4) of the final rule). These results also may 
be used to support a decision to remove workers from such locations.
    Under the medical monitoring program for cadmium, blood and urine 
samples must be collected at defined intervals from workers by 
physicians responsible for medical monitoring; these samples are sent to 
commerical laboratories that perform the required analyses and report 
results of these analyses to the responsible physicians. To ensure the 
accuracy and reliability of these laboratory analyses, the laboratories 
to which samples are submitted should participate in an ongoing and 
efficacious proficiency testing program. Availability of proficiency 
testing programs may vary with the analyses performed.
    To test proficiency in the analysis of CDB, CDU and B2MU, a 
laboratory should participate either in the interlaboratory comparison 
program operated by the Centre de Toxicologie du Quebec (CTQ) or an 
equivalent program. (Currently, no laboratory in the U.S. performs 
proficiency testing on CDB, CDU or B2MU.) Under this program, CTQ sends 
participating laboratories 18 samples of each analyte (CDB, CDU and/or 
B2MU) annually for analysis. Participating laboratories must return the 
results of these analyses to CTQ within four to five weeks after 
receiving the samples.
    The CTQ program pools analytical results from many participating 
laboratories to derive consensus mean values for each of the samples 
distributed. Results reported by each laboratory then are compared 
against these consensus means for the analyzed samples to determine the 
relative performance of each laboratory. The proficiency of a 
participating laboratory is a function of the extent of agreement 
between results submitted by the participating laboratory and the 
consensus values for the set of samples analyzed.
    Proficiency testing for CRTU analysis (which should be performed 
with CDU and B2MU analyses to evaluate the results properly) also is 
recommended. In the U.S., only the College of American Pathologists 
(CAP) currently conducts CRTU proficiency testing; participating 
laboratories should be accredited for CRTU analysis by the CAP.
    Results of the proficiency evaluations will be forwarded to the 
participating laboratory by the proficiency-testing laboratory, as well 
as to physicians designated by the participating laboratory to receive 
this information. In addition, the participating laboratory should, on 
request, submit the results of their internal Quality Assurance/Quality 
Control (QA/QC) program for each analytic procedure (i.e., CDB, CDU and/
or B2MU) to physicians designated to receive the proficiency results. 
For participating laboratories offering CDU and/or B2MU analyses, QA/QC 
documentation also should be provided for CRTU analysis. (Laboratories 
should provide QA/QC information regarding CRTU analysis directly to the 
requesting physician if they perform the analysis in-house; if CRTU 
analysis is performed by another laboratory under contract, this 
information should be provided to the physician by the contract 
laboratory.)
    QA/QC information, along with the actual biological specimen 
measurements, should be provided to the responsible physician using 
standard formats. These physicians then may collate the QA/QC 
information with proficiency test results to compare the relative 
performance of laboratories, as well as to facilitate evaluation of the 
worker monitoring data. This information supports decisions made by the 
physician with regard to the biological monitoring program, and for 
mandating medical removal.
    This protocol describes procedures that may be used by the 
responsible physicians to identify laboratories most likely to be 
proficient in the analysis of samples used in the biological monitoring 
of cadmium; also provided are procedures for record keeping and 
reporting by laboratories participating in proficiency testing programs, 
and recommendations to assist these physicians in interpreting 
analytical results determined by participating laboratories. As the 
collection and handling of samples affects the quality of the data, 
recommendations are

[[Page 185]]

made for these tasks. Specifications for analytical methods to be used 
in the medical monitoring program are included in this protocol as well.
    In conclusion, this document is intended as a supplement to 
characterize and maintain the quality of medical monitoring data 
collected under the final cadmium rule promulgated by OSHA (29 CFR part 
1910). OSHA has been granted authority under the Occupational Safety and 
Health Act of 1970 to protect workers from the effects of exposure to 
hazardous substances in the work place and to mandate adequate 
monitoring of workers to determine when adverse health effects may be 
occurring. This nonmandatory protocol is intended to provide guidelines 
and recommendations to improve the accuracy and reliability of the 
procedures used to analyze the biological samples collected as part of 
the medical monitoring program for cadmium.

                             2.0 Definitions

    When the terms below appear in this protocol, use the following 
definitions.
    Accuracy: A measure of the bias of a data set. Bias is a systematic 
error that is either inherent in a method or caused by some artifact or 
idiosyncracy of the measurement system. Bias is characterized by a 
consistent deviation (positive or negative) in the results from an 
accepted reference value.
    Arithmetic Mean: The sum of measurements in a set divided by the 
number of measurements in a set.
    Blind Samples: A quality control procedure in which the 
concentration of analyte in the samples should be unknown to the analyst 
at the time that the analysis is performed.
    Coefficient of Variation: The ratio of the standard deviation of a 
set of measurements to the mean (arithmetic or geometric) of the 
measurements.
    Compliance Samples: Samples from exposed workers sent to a 
participating laboratory for analysis.
    Control Charts: Graphic representations of the results for quality 
control samples being analyzed by a participating laboratory.
    Control Limits: Statistical limits which define when an analytic 
procedure exceeds acceptable parameters; control limits provide a method 
of assessing the accuracy of analysts, laboratories, and discrete 
analytic runs.
    Control Samples: Quality control samples.
    F/T: The measured amount of an analyte divided by the theoretical 
value (defined below) for that analyte in the sample analyzed; this 
ratio is a measure of the recovery for a quality control sample.
    Geometric Mean: The natural antilog of the mean of a set of natural 
log-transformed data.
    Geometric Standard Deviation: The antilog of the standard deviation 
of a set of natural log-transformed data.
    Limit of Detection: Using a predefined level of confidence, this is 
the lowest measured value at which some of the measured material is 
likely to have come from the sample.
    Mean: A central tendency of a set of data; in this protocol, this 
mean is defined as the arithmetic mean (see definition of arithmetic 
mean above) unless stated otherwise.
    Performance: A measure of the overall quality of data reported by a 
laboratory.
    Pools: Groups of quality-control samples to be established for each 
target value (defined below) of an analyte. For the protocol provided in 
attachment 3, for example, the theoretical value of the quality control 
samples of the pool must be within a range defined as plus or minus 
() 50% of the target value. Within each analyte 
pool, there must be quality control samples of at least 4 theoretical 
values.
    Precision: The extent of agreement between repeated, independent 
measurements of the same quantity of an analyte.
    Proficiency: The ability to satisfy a specified level of analyte 
performance.
    Proficiency Samples: Specimens, the values of which are unknown to 
anyone at a participating laboratory, and which are submitted by a 
participating laboratory for proficiency testing.
    Quality or Data Quality: A measure of the confidence in the 
measurement value.
    Quality Control (QC) Samples: Specimens, the value of which is 
unknown to the analyst, but is known to the appropriate QA/QC personnel 
of a participating laboratory; when used as part of a laboratory QA/QC 
program, the theoretical values of these samples should not be known to 
the analyst until the analyses are complete. QC samples are to be run in 
sets consisting of one QC sample from each pool (see definition of 
``pools'' above).
    Sensitivity: For the purposes of this protocol, the limit of 
detection.
    Standard Deviation: A measure of the distribution or spread of a 
data set about the mean; the standard deviation is equal to the positive 
square root of the variance, and is expressed in the same units as the 
original measurements in the data set.
    Standards: Samples with values known by the analyst and used to 
calibrate equipment and to check calibration throughout an analytic run. 
In a laboratory QA/QC program, the values of the standards must exceed 
the values obtained for compliance samples such that the lowest standard 
value is near the limit of detection and the highest standard is higher 
than the highest compliance sample or QC sample. Standards of at least 
three different values are to be used for calibration, and should be 
constructed from at least 2 different sources.

[[Page 186]]

    Target Value: Those values of CDB, CDU or B2MU which trigger some 
action as prescribed in the medical surveillance section of the 
regulatory text of the final cadmium rule. For CDB, the target values 
are 5, 10 and 15 [micro]g/l. For CDU, the target values are 3, 7, and 15 
[micro]g/g CRTU. For B2 MU, the target values are 300, 750 
and 1500 [micro]g/g CRTU. (Note that target values may vary as a 
function of time.)
    Theoretical Value (or Theoretical Amount): The reported 
concentration of a quality-control sample (or calibration standard) 
derived from prior characterizations of the sample.
    Value or Measurement Value: The numerical result of a measurement.
    Variance: A measure of the distribution or spread of a data set 
about the mean; the variance is the sum of the squares of the 
differences between the mean and each discrete measurement divided by 
one less than the number of measurements in the data set.

                              3.0 Protocol

    This protocol provides procedures for characterizing and maintaining 
the quality of analytic results derived for the medical monitoring 
program mandated for workers under the final cadmium rule.

                              3.1 Overview

    The goal of this protocol is to assure that medical monitoring data 
are of sufficient quality to facilitate proper interpretation. The data 
quality objectives (DQOs) defined for the medical monitoring program are 
summarized in Table 1. Based on available information, the DQOs 
presented in Table 1 should be achievable by the majority of 
laboratories offering the required analyses commercially; OSHA 
recommends that only laboratories meeting these DQOs be used for the 
analysis of biological samples collected for monitoring cadmium 
exposure.

         Table 1--Recommended Data Quality Objectives (DQOs) for the Cadmium Medical Monitoring Program
----------------------------------------------------------------------------------------------------------------
                                                          Precision
    Analyte/concentration pool      Limit of detection     (CV) (%)                    Accuracy
----------------------------------------------------------------------------------------------------------------
Cadmium in blood.................  0.5 [micro]g/l......  ...........  1 [micro]g/l or 15%
                                                                       of the mean.
    <=2 [micro]g/l...............  ....................           40
    2[micro]g/l.......  ....................           20
Cadmium in urine.................  0.5 [micro]g/g        ...........  1 [micro]g/l or 15%
                                    creatinine.                        of the mean.
    <=2 [micro]g/l creatinine....  ....................           40
    2[micro]g/l         ....................           20
     creatinine.
[beta]-2-microglobulin in urine:   100 [micro]g/g                  5  15% of the mean.
 100 [micro]g/g creatine.           creatinine.
----------------------------------------------------------------------------------------------------------------

    To satisfy the DQOs presented in Table 1, OSHA provides the 
following guidelines:
    1. Procedures for the collection and handling of blood and urine are 
specified (Section 3.4.1 of this protocol);
    2. Preferred analytic methods for the analysis of CDB, CDU and B2MU 
are defined (and a method for the determination of CRTU also is 
specified since CDU and B2MU results are to be normalized to the level 
of CRTU).
    3. Procedures are described for identifying laboratories likely to 
provide the required analyses in an accurate and reliable manner;
    4. These guidelines (Sections 3.2.1 to 3.2.3, and Section 3.3) 
include recommendations regarding internal QA/QC programs for 
participating laboratories, as well as levels of proficiency through 
participation in an interlaboratory proficiency program;
    5. Procedures for QA/QC record keeping (Section 3.3.2), and for 
reporting QC/QA results are described (Section 3.3.3); and,
    6. Procedures for interpreting medical monitoring results are 
specified (Section 3.4.3).
    Methods recommended for the biological monitoring of eligible 
workers are:
    1. The method of Stoeppler and Brandt (1980) for CDB determinations 
(limit of detection: 0.5 [micro]g/l);
    2. The method of Pruszkowska et al. (1983) for CDU determinations 
(limit of detection: 0.5 [micro]g/l of urine); and,
    3. The Pharmacia Delphia test kit (Pharmacia 1990) for the 
determination of B2MU (limit of detection: 100 [micro]g/l urine).
    Because both CDU and B2MU should be reported in [micro]g/g CRTU, an 
independent determination of CRTU is recommended. Thus, both the OSHA 
Salt Lake City Technical Center (OSLTC) method (OSHA, no date) and the 
Jaffe method (Du Pont, no date) for the determination of CRTU are 
specified under this protocol (i.e., either of these 2 methods may be 
used). Note that although detection limits are not reported for either 
of these CRTU methods, the range of measurements expected for CRTU (0.9-
1.7 [micro]g/l) are well above the likely limit of detection for either 
of these methods (Harrison, 1987).
    Laboratories using alternate methods should submit sufficient data 
to the responsible physicians demonstrating that the alternate method is 
capable of satisfying the

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defined data quality objectives of the program. Such laboratories also 
should submit a QA/QC plan that documents the performance of the 
alternate method in a manner entirely equivalent to the QA/QC plans 
proposed in Section 3.3.1.

                 3.2 Duties of the Responsible Physician

    The responsible physician will evaluate biological monitoring 
results provided by participating laboratories to determine whether such 
laboratories are proficient and have satisfied the QA/QC 
recommendations. In determining which laboratories to employ for this 
purpose, these physicians should review proficiency and QA/QC data 
submitted to them by the participating laboratories.
    Participating laboratories should demonstrate proficiency for each 
analyte (CDU, CDB and B2MU) sampled under the biological monitoring 
program. Participating laboratories involved in analyzing CDU and B2MU 
also should demonstrate proficiency for CRTU analysis, or provide 
evidence of a contract with a laboratory proficient in CRTU analysis.

     3.2.1 Recommendations for Selecting Among Existing Laboratories

    OSHA recommends that existing laboratories providing commercial 
analyses for CDB, CDU and/or B2MU for the medical monitoring program 
satisfy the following criteria:
    1. Should have performed commercial analyses for the appropriate 
analyte (CDB, CDU and/or B2MU) on a regular basis over the last 2 years;
    2. Should provide the responsible physician with an internal QA/QC 
plan;
    3. If performing CDU or B2MU analyses, the participating laboratory 
should be accredited by the CAP for CRTU analysis, and should be 
enrolled in the corresponding CAP survey (note that alternate 
credentials may be acceptable, but acceptability is to be determined by 
the responsible physician); and,
    4. Should have enrolled in the CTQ interlaboratory comparison 
program for the appropriate analyte (CDB, CDU and/or B2MU).
    Participating laboratories should submit appropriate documentation 
demonstrating compliance with the above criteria to the responsible 
physician. To demonstrate compliance with the first of the above 
criteria, participating laboratories should submit the following 
documentation for each analyte they plan to analyze (note that each 
document should cover a period of at least 8 consecutive quarters, and 
that the period designated by the term ``regular analyses'' is at least 
once a quarter):
    1. Copies of laboratory reports providing results from regular 
analyses of the appropriate analyte (CDB, CDU and/or B2MU);
    2. Copies of 1 or more signed and executed contracts for the 
provision of regular analyses of the appropriate analyte (CDB, CDU and/
or B2MU); or,
    3. Copies of invoices sent to 1 or more clients requesting payment 
for the provision of regular analyses of the appropriate analyte (CDB, 
CDU and/or B2MU). Whatever the form of documentation submitted, the 
specific analytic procedures conducted should be identified directly. 
The forms that are copied for submission to the responsible physician 
also should identify the laboratory which provided these analyses.
    To demonstrate compliance with the second of the above criteria, a 
laboratory should submit to the responsible physician an internal QA/QC 
plan detailing the standard operating procedures to be adopted for 
satisfying the recommended QA/QC procedures for the analysis of each 
specific analyte (CDB, CDU and/or B2MU). Procedures for internal QA/QC 
programs are detailed in Section 3.3.1 below.
    To satisfy the third of the above criteria, laboratories analyzing 
for CDU or B2MU also should submit a QA/QC plan for creatinine analysis 
(CRTU); the QA/QC plan and characterization analyses for CRTU must come 
from the laboratory performing the CRTU analysis, even if the CRTU 
analysis is being performed by a contract laboratory.
    Laboratories enrolling in the CTQ program (to satisfy the last of 
the above criteria) must remit, with the enrollment application, an 
initial fee of approximately $100 per analyte. (Note that this fee is 
only an estimate, and is subject to revision without notice.) 
Laboratories should indicate on the application that they agree to have 
proficiency test results sent by the CTQ directly to the physicians 
designated by participating laboratories.
    Once a laboratory's application is processed by the CTQ, the 
laboratory will be assigned a code number which will be provided to the 
laboratory on the initial confirmation form, along with identification 
of the specific analytes for which the laboratory is participating. 
Confirmation of participation will be sent by the CTQ to physicians 
designated by the applicant laboratory.

  3.2.2 Recommended Review of Laboratories Selected To Perform Analyses

    Six months after being selected initially to perform analyte 
determinations, the status of participating laboratories should be 
reviewed by the responsible physicians. Such reviews should then be 
repeated every 6 months or whenever additional proficiency or QA/QC 
documentation is received (whichever occurs first).
    As soon as the responsible physician has received the CTQ results 
from the first 3 rounds of proficiency testing (i.e., 3 sets of 3 
samples each for CDB, CDU and/or B2MU) for

[[Page 188]]

a participating laboratory, the status of the laboratory's continued 
participation should be reviewed. Over the same initial 6-month period, 
participating laboratories also should provide responsible physicians 
the results of their internal QA/QC monitoring program used to assess 
performance for each analyte (CDB, CDU and/or B2MU) for which the 
laboratory performs determinations. This information should be submitted 
using appropriate forms and documentation.
    The status of each participating laboratory should be determined for 
each analyte (i.e., whether the laboratory satisfies minimum proficiency 
guidelines based on the proficiency samples sent by the CTQ and the 
results of the laboratory's internal QA/QC program). To maintain 
competency for analysis of CDB, CDU and/or B2MU during the first review, 
the laboratory should satisfy performance requirements for at least 2 of 
the 3 proficiency samples provided in each of the 3 rounds completed 
over the 6-month period. Proficiency should be maintained for the 
analyte(s) for which the laboratory conducts determinations.
    To continue participation for CDU and/or B2MU analyse, laboratories 
also should either maintain accreditation for CRTU analysis in the CAP 
program and participate in the CAP surveys, or they should contract the 
CDU and B2MU analyses to a laboratory which satisfies these requirements 
(or which can provide documentation of accreditation/participation in an 
equivalent program).
    The performance requirement for CDB analysis is defined as an 
analytical result within 1 [micro]g/l blood or 15% 
of the consensus mean (whichever is greater). For samples exhibiting a 
consensus mean less than 1 [micro]g/l, the performance requirement is 
defined as a concentration between the detection limit of the analysis 
and a maximum of 2 [micro]g/l. The purpose for redefining the acceptable 
interval for low CDB values is to encourage proper reporting of the 
actual values obtained during measurement; laboratories, therefore, will 
not be penalized (in terms of a narrow range of acceptability) for 
reporting measured concentrations smaller than 1 [micro]g/l.
    The performance requirement for CDU analysis is defined as an 
analytical result within 1 [micro]g/l urine or 15% 
of the consensus mean (whichever is greater). For samples exhibiting a 
consensus mean less than 1 [micro]g/l urine, the performance requirement 
is defined as a concentration between the detection limit of the 
analysis and a maximum of 2 [micro]g/l urine. Laboratories also should 
demonstrate proficiency in creatinine analysis as defined by the CAP. 
Note that reporting CDU results, other than for the CTQ proficiency 
samples (i.e., compliance samples), should be accompanied with results 
of analyses for CRTU, and these 2 sets of results should be combined to 
provide a measure of CDU in units of [micro]g/g CRTU.
    The performance requirement for B2MU is defined as analytical 
results within 15% of the consensus mean. Note 
that reporting B2MU results, other than for CTQ proficiency samples 
(i.e., compliance samples), should be accompanied with results of 
analyses for CRTU, and these 2 sets of results should be combined to 
provide a measure of B2MU in units of [micro]g/g CRTU.
    There are no recommended performance checks for CRTU analyses. As 
stated previously, laboratories performing CRTU analysis in support of 
CDU or B2MU analyses should be accredited by the CAP, and participating 
in the CAP's survey for CRTU.
    Following the first review, the status of each participating 
laboratory should be reevaluated at regular intervals (i.e., 
corresponding to receipt of results from each succeeding round of 
proficiency testing and submission of reports from a participating 
laboratory's internal QA/QC program).
    After a year of collecting proficiency test results, the following 
proficiency criterion should be added to the set of criteria used to 
determine the participating laboratory's status (for analyzing CDB, CDU 
and/or B2MU): A participating laboratory should not fail performance 
requirements for more than 4 samples from the 6 most recent consecutive 
rounds used to assess proficiency for CDB, CDU and/or B2MU separately 
(i.e., a total of 18 discrete proficiency samples for each analyte). 
Note that this requirement does not replace, but supplements, the 
recommendation that a laboratory should satisfy the performance criteria 
for at least 2 of the 3 samples tested for each round of the program.

3.2.3 Recommendations for Selecting Among Newly-Formed Laboratories (or 
  Laboratories That Previously Failed To Meet the Protocol Guidelines)

    OSHA recommends that laboratories that have not previously provided 
commercial analyses of CDB, CDU and/or B2MU (or have done so for a 
period less than 2 years), or which have provided these analyses for 2 
or more years but have not conformed previously with these protocol 
guidelines, should satisfy the following provisions for each analyte for 
which determinations are to be made prior to being selected to analyze 
biological samples under the medical monitoring program:
    1. Submit to the responsible physician an internal QA/QC plan 
detailing the standard operating procedures to be adopted for satisfying 
the QA/QC guidelines (guidelines for internal QA/QC programs are 
detailed in Section 3.3.1);
    2. Submit to the responsible physician the results of the initial 
characterization analyses for each analyte for which determinations are 
to be made;

[[Page 189]]

    3. Submit to the responsible physician the results, for the initial 
6-month period, of the internal QA/QC program for each analyte for which 
determinations are to be made (if no commercial analyses have been 
conducted previously, a minimum of 2 mock standardization trials for 
each analyte should be completed per month for a 6-month period);
    4. Enroll in the CTQ program for the appropriate analyte for which 
determinations are to be made, and arrange to have the CTQ program 
submit the initial confirmation of participation and proficiency test 
results directly to the designated physicians. Note that the designated 
physician should receive results from 3 completed rounds from the CTQ 
program before approving a laboratory for participation in the 
biological monitoring program;
    5. Laboratories seeking participation for CDU and/or B2MU analyses 
should submit to the responsible physician documentation of 
accreditation by the CAP for CRTU analyses performed in conjunction with 
CDU and/or B2MU determinations (if CRTU analyses are conducted by a 
contract laboratory, this laboratory should submit proof of CAP 
accreditation to the responsible physician); and,
    6. Documentation should be submitted on an appropriate form.
    To participate in CDB, CDU and/or B2MU analyses, the laboratory 
should satisfy the above criteria for a minimum of 2 of the 3 
proficiency samples provided in each of the 3 rounds of the CTQ program 
over a 6-month period; this procedure should be completed for each 
appropriate analyte. Proficiency should be maintained for each analyte 
to continue participation. Note that laboratories seeking participation 
for CDU or B2MU also should address the performance requirements for 
CRTU, which involves providing evidence of accreditation by the CAP and 
participation in the CAP surveys (or an equivalent program).
    The performance requirement for CDB analysis is defined as an 
analytical result within 1 [micro]g/l or 15% of 
the consensus mean (whichever is greater). For samples exhibiting a 
consensus mean less than 1 [micro]g/l, the performance requirement is 
defined as a concentration between the detection limit of the analysis 
and a maximum of 2 [micro]g/l. The purpose of redefining the acceptable 
interval for low CDB values is to encourage proper reporting of the 
actual values obtained during measurement; laboratories, therefore, will 
not be penalized (in terms of a narrow range of acceptability) for 
reporting measured concentrations less than 1 [micro]g/l.
    The performance requirement for CDU analysis is defined as an 
analytical result within 1 [micro]g/l urine or 15% 
of the consensus mean (whichever is greater). For samples exhibiting a 
consensus mean less than 1 [micro]g/l urine, the performance requirement 
is defined as a concentration that falls between the detection limit of 
the analysis and a maximum of 2 [micro]g/l urine. Performance 
requirements for the companion CRTU analysis (defined by the CAP) also 
should be met. Note that reporting CDU results, other than for CTQ 
proficiency testing should be accompanied with results of CRTU analyses, 
and these 2 sets of results should be combined to provide a measure of 
CDU in units of [micro]g/g CRTU.
    The performance requirement for B2MU is defined as an analytical 
result within 15% of the consensus mean. Note that 
reporting B2MU results, other than for CTQ proficiency testing should be 
accompanied with results of CRTU analysis, these 2 sets of results 
should be combined to provide a measure of B2MU in units of [micro]g/g 
CRTU.
    Once a new laboratory has been approved by the responsible physician 
for conducting analyte determinations, the status of this approval 
should be reviewed periodically by the responsible physician as per the 
criteria presented under Section 3.2.2.
    Laboratories which have failed previously to gain approval of the 
responsible physician for conducting determinations of 1 or more 
analytes due to lack of compliance with the criteria defined above for 
existing laboratories (Section 3.2.1), may obtain approval by satisfying 
the criteria for newly-formed laboratories defined under this section; 
for these laboratories, the second of the above criteria may be 
satisfied by submitting a new set of characterization analyses for each 
analyte for which determinations are to be made.
    Reevaluation of these laboratories is discretionary on the part of 
the responsible physician. Reevaluation, which normally takes about 6 
months, may be expedited if the laboratory can achieve 100% compliance 
with the proficiency test criteria using the 6 samples of each analyte 
submitted to the CTQ program during the first 2 rounds of proficiency 
testing.
    For laboratories seeking reevaluation for CDU or B2MU analysis, the 
guidelines for CRTU analyses also should be satisfied, including 
accreditation for CRTU analysis by the CAP, and participation in the CAP 
survey program (or accreditation/participation in an equivalent 
program).

          3.2.4 Future Modifications to the Protocol Guidelines

    As participating laboratories gain experience with analyses for CDB, 
CDU and B2MU, it is anticipated that the performance achievable by the 
majority of laboratories should improve until it approaches that 
reported by the research groups which developed each method. OSHA, 
therefore, may choose to recommend stricter performance guidelines in 
the future as the overall performance of participating laboratories 
improves.

[[Page 190]]

             3.3 Guidelines for Record Keeping and Reporting

    To comply with these guidelines, participating laboratories should 
satisfy the above-stated performance and proficiency recommendations, as 
well as the following internal QA/QC, record keeping, and reporting 
provisions.
    If a participating laboratory fails to meet the provisions of these 
guidelines, it is recommended that the responsible physician disapprove 
further analyses of biological samples by that laboratory until it 
demonstrates compliance with these guidelines. On disapproval, 
biological samples should be sent to a laboratory that can demonstrate 
compliance with these guidelines, at least until the former laboratory 
is reevaluated by the responsible physician and found to be in 
compliance.
    The following record keeping and reporting procedures should be 
practiced by participating laboratories.

       3.3.1 Internal Quality Assurance/Quality Control Procedures

    Laboratories participating in the cadmium monitoring program should 
develop and maintain an internal quality assurance/quality control (QA/
QC) program that incorporates procedures for establishing and 
maintaining control for each of the analytic procedures (determinations 
of CDB, CDU and/or B2MU) for which the laboratory is seeking 
participation. For laboratories analyzing CDU and/or B2MU, a QA/QC 
program for CRTU also should be established.
    Written documentation of QA/QC procedures should be described in a 
formal QA/QC plan; this plan should contain the following information: 
Sample acceptance and handling procedures (i.e., chain-of-custody); 
sample preparation procedures; instrument parameters; calibration 
procedures; and, calculations. Documentation of QA/QC procedures should 
be sufficient to identify analytical problems, define criteria under 
which analysis of compliance samples will be suspended, and describe 
procedures for corrective actions.

    3.3.1.1 QA/QC procedures for establishing control of CDB and CDU 
                                analyses

    The QA/QC program for CDB and CDU should address, at a minimum, 
procedures involved in calibration, establishment of control limits, 
internal QC analyses and maintaining control, and corrective-action 
protocols. Participating laboratory should develop and maintain 
procedures to assure that analyses of compliance samples are within 
control limits, and that these procedures are documented thoroughly in a 
QA/QC plan.
    A nonmandatory QA/QC protocol is presented in Attachment 1. This 
attachment is illustrative of the procedures that should be addressed in 
a proper QA/QC program.
    Calibration. Before any analytic runs are conducted, the analytic 
instrument should be calibrated. Calibration should be performed at the 
beginning of each day on which QC and/or compliance samples are run. 
Once calibration is established, QC or compliance samples may be run. 
Regardless of the type of samples run, about every fifth sample should 
serve as a standard to assure that calibration is being maintained.
    Calibration is being maintained if the standard is within 15% of its theoretical value. If a standard is more than 
15% of its theoretical value, the run has exceeded 
control limits due to calibration error; the entire set of samples then 
should be reanalyzed after recalibrating or the results should be 
recalculated based on a statistical curve derived from that set of 
standards.
    It is essential that the value of the highest standard analyzed be 
higher than the highest sample analyzed; it may be necessary, therefore, 
to run a high standard at the end of the run, which has been selected 
based on results obtained over the course of the run (i.e., higher than 
any standard analyzed to that point).
    Standards should be kept fresh; as samples age, they should be 
compared with new standards and replaced if necessary.
    Internal Quality Control Analyses. Internal QC samples should be 
determined interspersed with analyses of compliance samples. At a 
minimum, these samples should be run at a rate of 5% of the compliance 
samples or at least one set of QC samples per analysis of compliance 
samples, whichever is greater. If only 2 samples are run, they should 
contain different levels of cadmium.
    Internal QC samples may be obtained as commercially-available 
reference materials and/or they may be internally prepared. Internally-
prepared samples should be well characterized and traced, or compared to 
a reference material for which a consensus value is available.
    Levels of cadmium contained in QC samples should not be known to the 
analyst prior to reporting the results of the analysis.
    Internal QC results should be plotted or charted in a manner which 
describes sample recovery and laboratory control limits.
    Internal Control Limits. The laboratory protocol for evaluating 
internal QC analyses per control limits should be clearly defined. 
Limits may be based on statistical methods (e.g., as 2[sigma] from the 
laboratory mean recovery), or on proficiency testing limits (e.g.,1[micro]g or 15% of the mean, whichever is greater). 
Statistical limits that exceed 40% should be 
reevaluated to determine the source error in the analysis.
    When laboratory limits are exceeded, analytic work should terminate 
until the source

[[Page 191]]

of error is determined and corrected; compliance samples affected by the 
error should be reanalyzed. In addition, the laboratory protocol should 
address any unusual trends that develop which may be biasing the 
results. Numerous, consecutive results above or below laboratory mean 
recoveries, or outside laboratory statistical limits, indicate that 
problems may have developed.
    Corrective Actions. The QA/QC plan should document in detail 
specific actions taken if control limits are exceeded or unusual trends 
develop. Corrective actions should be noted on an appropriate form, 
accompanied by supporting documentation.
    In addition to these actions, laboratories should include whatever 
additional actions are necessary to assure that accurate data are 
reported to the responsible physicians.
    Reference Materials. The following reference materials may be 
available:

                         Cadmium in Blood (CDB)

    1. Centre de Toxicologie du Quebec, Le Centre Hospitalier de 
l'Universite Laval, 2705 boul. Laurier, Quebec, Que., Canada G1V 4G2. 
(Prepared 6 times per year at 1-15 [micro]g Cd/l.)
    2. H. Marchandise, Community Bureau of Reference-BCR, Directorate 
General XII, Commission of the European Communities, 200, rue de la Loi, 
B-1049, Brussels, Belgium. (Prepared as Bl CBM-1 at 5.37 [micro]g Cd/l, 
and Bl CBM-2 at 12.38 [micro]g Cd/l.)
    3. Kaulson Laboratories Inc., 691 Bloomfield Ave., Caldwell, NJ 
07006; tel: (201) 226-9494, FAX (201) 226-3244. (Prepared as 
0141 [As, Cd, Hg, Pb] at 2 levels.)

                         Cadmium in Urine (CDU)

    1. Centre de Toxicologie du Quebec, Le Centre Hospitalier de 
l'Universite Laval, 2705 boul. Laurier, Quebec, Que., Canada G1V 4G2. 
(Prepared 6 times per year.)
    2. National Institute of Standards and Technology (NIST), Dept. of 
Commerce, Gaithersburg, MD; tel: (301) 975-6776. (Prepared as SRM 2670 
freeze-dried urine [metals]; set includes normal and elevated levels of 
metals; cadmium is certified for elevated level of 88.0 [micro]g/l in 
reconstituted urine.)
    3. Kaulson Laboratories Inc., 691 Bloomfield Ave., Caldwell, NJ 
07006; tel: (201) 226-9494, FAX (201) 226-3244. (Prepared as 
0140 [As, Cd, Hg, Pb] at 2 levels.)

        3.3.1.2 QA/QC procedures for establishing control of B2MU

    A written, detailed QA/QC plan for B2MU analysis should be 
developed. The QA/QC plan should contain a protocol similar to those 
protocols developed for the CDB/CDU analyses. Differences in analyses 
may warrant some differences in the QA/QC protocol, but procedures to 
ensure analytical integrity should be developed and followed.
    Examples of performance summaries that can be provided include 
measurements of accuracy (i.e., the means of measured values versus 
target values for the control samples) and precision (i.e., based on 
duplicate analyses). It is recommended that the accuracy and precision 
measurements be compared to those reported as achievable by the 
Pharmacia Delphia kit (Pharmacia 1990) to determine if and when 
unsatisfactory analyses have arisen. If the measurement error of 1 or 
more of the control samples is more than 15%, the run exceeds control 
limits. Similarly, this decision is warranted when the average CV for 
duplicate samples is greater than 5%.

                   3.3.2 Procedures for Record Keeping

    To satisfy reporting requirements for commercial analyses of CDB, 
CDU and/or B2MU performed for the medical monitoring program mandated 
under the cadmium rule, participating laboratories should maintain the 
following documentation for each analyte:
    1. For each analytic instrument on which analyte determinations are 
made, records relating to the most recent calibration and QC sample 
analyses;
    2. For these instruments, a tabulated record for each analyte of 
those determinations found to be within and outside of control limits 
over the past 2 years;
    3. Results for the previous 2 years of the QC sample analyses 
conducted under the internal QA/QC program (this information should be: 
Provided for each analyte for which determinations are made and for each 
analytic instrument used for this purpose, sufficient to demonstrate 
that internal QA/QC programs are being executed properly, and consistent 
with data sent to responsible physicians.
    4. Duplicate copies of monitoring results for each analyte sent to 
clients during the previous 5 years, as well as associated information; 
supporting material such as chain-of-custody forms also should be 
retained; and,
    5. Proficiency test results and related materials received while 
participating in the CTQ interlaboratory program over the past 2 years; 
results also should be tabulated to provide a serial record of relative 
error (derived per Section 3.3.3 below).

                       3.3.3 Reporting Procedures

    Participating laboratories should maintain these documents: QA/QC 
program plans; QA/QC status reports; CTQ proficiency program reports; 
and, analytical data reports. The information that should be included in 
these reports is summarized in Table 2; a copy of each report should be 
sent to the responsible physician.

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   Table 2--Reporting Procedures for Laboratories Participating in the
                   Cadmium Medical Monitoring Program
------------------------------------------------------------------------
                                 Frequency (time
            Report                    frame)              Contents
------------------------------------------------------------------------
1 QA/QC Program Plan..........  Once (initially).  A detailed
                                                    description of the
                                                    QA/QC protocol to be
                                                    established by the
                                                    laboratory to
                                                    maintain control of
                                                    analyte
                                                    determinations.
2 QA/QC Status Report.........  Every 2 months...  Results of the QC
                                                    samples incorporated
                                                    into regular runs
                                                    for each instrument
                                                    (over the period
                                                    since the last
                                                    report).
3 Proficiency Report..........  Attached to every  Results from the last
                                 data report.       full year of
                                                    proficiency samples
                                                    submitted to the CTQ
                                                    program and Results
                                                    of the 100 most
                                                    recent QC samples
                                                    incorporated into
                                                    regular runs for
                                                    each instrument.
4 Analytical Data Report......  For all reports    Date the sample was
                                 of data results.   received; Date the
                                                    sample was analyzed;
                                                    Appropriate chain-of-
                                                    custody information;
                                                    Types of analyses
                                                    performed; Results
                                                    of the requested
                                                    analyses and Copy of
                                                    the most current
                                                    proficiency report.
------------------------------------------------------------------------

    As noted in Section 3.3.1, a QA/QC program plan should be developed 
that documents internal QA/QC procedures (defined under Section 3.3.1) 
to be implemented by the participating laboratory for each analyte; this 
plan should provide a list identifying each instrument used in making 
analyte determinations.
    A QA/QC status report should be written bimonthly for each analyte. 
In this report, the results of the QC program during the reporting 
period should be reported for each analyte in the following manner: The 
number (N) of QC samples analyzed during the period; a table of the 
target levels defined for each sample and the corresponding measured 
values; the mean of F/T value (as defined below) for the set of QC 
samples run during the period; and, use of X 2[sigma] (as defined below) for the set of QC samples 
run during the period as a measure of precision.
    As noted in Section 2, an F/T value for a QC sample is the ratio of 
the measured concentration of analyte to the established (i.e., 
reference) concentration of analyte for that QC sample. The equation 
below describes the derivation of the mean for F/T values, X, (with N 
being the total number of samples analyzed):
[GRAPHIC] [TIFF OMITTED] TC28OC91.012

The standard deviation, [sigma], for these measurements is derived using 
the following equation (note that 2[sigma] is twice this value):
[GRAPHIC] [TIFF OMITTED] TC28OC91.013

    The nonmandatory QA/QC protocol (see Attachment 1) indicates that QC 
samples should be divided into several discrete pools, and a separate 
estimate of precision for each pools then should be derived. Several 
precision estimates should be provided for concentrations which differ 
in average value. These precision measures may be used to document 
improvements in performance with regard to the combined pool.
    Participating laboratories should use the CTQ proficiency program 
for each analyte. Results of the this program will be sent by CTQ 
directly to physicians designated by the participating laboratories. 
Proficiency results from the CTQ program are used to establish the 
accuracy of results from each participating laboratory, and should be 
provided to responsible physicians for use in trend analysis. A 
proficiency report consisting of these proficiency results should 
accompany data reports as an attachment.
    For each analyte, the proficiency report should include the results 
from the 6 previous proficiency rounds in the following format:
    1. Number (N) of samples analyzed;
    2. Mean of the target levels, (1/N)[Sigma]i, with 
Ti being a consensus mean for the sample;
    3. Mean of the measurements, (1/N)[Sigma]i, with 
Mi being a sample measurement;
    4. A measure of error defined by:

 (1/N)[Sigma](Ti- Mi)\2\

    Analytical data reports should be submitted to responsible 
physicians directly. For each sample, report the following information: 
The date the sample was received; the date the sample was analyzed; 
appropriate chain-of-custody information; the type(s) of analyses 
performed; and, the results of the analyses. This information should be 
reported on a form similar to the form provided an appropriate form. The 
most recent proficiency program report should accompany the analytical 
data reports (as an attachment).
    Confidence intervals for the analytical results should be reported 
as X2[sigma], with X being the measured value and 
2[sigma] the standard deviation calculated as described above.

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    For CDU or B2MU results, which are combined with CRTU measurements 
for proper reporting, the 95% confidence limits are derived from the 
limits for CDU or B2MU, (p), and the limits for CRTU, (q), as follows:
[GRAPHIC] [TIFF OMITTED] TC28OC91.014

For these calculations, X p is the measurement and 
confidence limits for CDU or B2MU, and Y q is the 
measurement and confidence limit for CRTU.
    Participating laboratories should notify responsible physicians as 
soon as they receive information indicating a change in their 
accreditation status with the CTQ or the CAP. These physicians should 
not be expected to wait until formal notice of a status change has been 
received from the CTQ or the CAP.

                     3.4 Instructions to Physicians

    Physicians responsible for the medical monitoring of cadmium-exposed 
workers must collect the biological samples from workers; they then 
should select laboratories to perform the required analyses, and should 
interpret the analytic results.

             3.4.1 Sample Collection and Holding Procedures

    Blood Samples. The following procedures are recommended for the 
collection, shipment and storage of blood samples for CDB analysis to 
reduce analytical variablility; these recommendations were obtained 
primarily through personal communications with J.P. Weber of the CTQ 
(1991), and from reports by the Centers for Disease Control (CDC, 1986) 
and Stoeppler and Brandt (1980).
    To the extent possible, blood samples should be collected from 
workers at the same time of day. Workers should shower or thoroughly 
wash their hands and arms before blood samples are drawn. The following 
materials are needed for blood sample collection: Alcohol wipes; sterile 
gauze sponges; band-aids; 20-gauge, 1.5-in. stainless steel needles 
(sterile); preprinted labels; tourniquets; vacutainer holders; 3-ml 
``metal free'' vacutainer tubes (i.e., dark-blue caps), with EDTA as an 
anti-coagulant; and, styrofoam vacutainer shipping containers.
    Whole blood samples are taken by venipuncture. Each blue-capped tube 
should be labeled or coded for the worker and company before the sample 
is drawn. (Blue-capped tubes are recommended instead of red-capped tubes 
because the latter may consist of red coloring pigment containing 
cadmium, which could contaminate the samples.) Immediately after 
sampling, the vacutainer tubes must be thoroughly mixed by inverting the 
tubes at least 10 times manually or mechanically using a Vortex device 
(for 15 sec). Samples should be refrigerated immediately or stored on 
ice until they can be packed for shipment to the participating 
laboratory for analysis.
    The CDC recommends that blood samples be shipped with a ``cool pak'' 
to keep the samples cold during shipment. However, the CTQ routinely 
ships and receives blood samples for cadmium analysis that have not been 
kept cool during shipment. The CTQ has found no deterioration of cadmium 
in biological fluids that were shipped via parcel post without a cooling 
agent, even though these deliveries often take 2 weeks to reach their 
destination.
    Urine Samples. The following are recommended procedures for the 
collection, shipment and storage of urine for CDU and B2MU analyses, and 
were obtained primarily through personal communications with J.P. Weber 
of the CTQ (1991), and from reports by the CDC (1986) and Stoeppler and 
Brandt (1980).
    Single ``spot'' samples are recommended. As B2M can degrade in the 
bladder, workers should first empty their bladder and then drink a large 
glass of water at the start of the visit. Urine samples then should be 
collected within 1 hour. Separate samples should be collected for CDU 
and B2MU using the following materials: Sterile urine collection cups 
(250 ml); small sealable plastic bags; preprinted labels; 15-ml 
polypropylene or polyethylene screw-cap tubes; lab gloves (``metal 
free''); and, preservatives (as indicated).
    The sealed collection cup should be kept in the plastic bag until 
collection time. The workers should wash their hands with soap and water 
before receiving the collection cup. The collection cup should not be 
opened until just before voiding and the cup should be sealed 
immediately after filling. It is important that the inside of the 
container and cap are not touched by, or come into contact with, the 
body, clothing or other surfaces.
    For CDU analyzes, the cup is swirled gently to resuspend any solids, 
and the 15-ml tube is filled with 10-12 ml urine. The CDC recommends the 
addition of 100 [micro]l concentrated HNO3 as a preservative 
before sealing the tube and then freezing the sample. The CTQ recommends 
minimal handling and does not acidify their interlaboratory urine 
reference materials prior to shipment, nor do they freeze the sample for 
shipment. At the CTQ, if the urine sample has much sediment, the sample 
is acidified in the lab to free any cadmium in the precipitate.
    For B2M, the urine sample should be collected directly into a 
polyethylene bottle previously washed with dilute nitric acid. The pH of 
the urine should be measured and adjusted to 8.0 with 0.1 N NaOH 
immediately

[[Page 194]]

following collection. Samples should be frozen and stored at -20 [deg]C 
until testing is performed. The B2M in the samples should be stable for 
2 days when stored at 2-8 [deg]C, and for at least 2 months at -20 
[deg]C. Repeated freezing and thawing should be avoided to prevent 
denaturing the B2M (Pharmacia 1990).

            3.4.2 Recommendations for Evaluating Laboratories

    Using standard error data and the results of proficiency testing 
obtained from CTQ, responsible physicians can make an informed choice of 
which laboratory to select to analyze biological samples. In general, 
laboratories with small standard errors and little disparity between 
target and measured values tend to make precise and accurate sample 
determinations. Estimates of precision provided to the physicians with 
each set of monitoring results can be compared to previously-reported 
proficiency and precision estimates. The latest precision estimates 
should be at least as small as the standard error reported previously by 
the laboratory. Moreover, there should be no indication that precision 
is deteriorating (i.e., increasing values for the precision estimates). 
If precision is deteriorating, physicians may decide to use another 
laboratory for these analyses. QA/QC information provided by the 
participating laboratories to physicians can, therefore, assist 
physicians in evaluating laboratory performance.

                 3.4.3 Use and Interpretation of Results

    When the responsible physician has received the CDB, CDU and/or B2MU 
results, these results must be compared to the action levels discussed 
in the final rule for cadmium. The comparison of the sample results to 
action levels is straightforward. The measured value reported from the 
laboratory can be compared directly to the action levels; if the 
reported value exceeds an action level, the required actions must be 
initiated.

                             4.0 Background

    Cadmium is a naturally-occurring environmental contaminant to which 
humans are continually exposed in food, water, and air. The average 
daily intake of cadmium by the U.S. population is estimated to be 10-20 
[micro]g/day. Most of this intake is via ingestion, for which absorption 
is estimated at 4-7% (Kowal et al. 1979). An additional nonoccupational 
source of cadmium is smoking tobacco; smoking a pack of cigarettes a day 
adds an additional 2-4 [micro]g cadmium to the daily intake, assuming 
absorption via inhalation of 25-35% (Nordberg and Nordberg 1988; Friberg 
and Elinder 1988; Travis and Haddock 1980).
    Exposure to cadmium fumes and dusts in an occupational setting where 
air concentrations are 20-50 [micro]g/m\3\ results in an additional 
daily intake of several hundred micrograms (Friberg and Elinder 1988, p. 
563). In such a setting, occupational exposure to cadmium occurs 
primarily via inhalation, although additional exposure may occur through 
the ingestion of material via contaminated hands if workers eat or smoke 
without first washing. Some of the particles that are inhaled initially 
may be ingested when the material is deposited in the upper respiratory 
tract, where it may be cleared by mucociliary transport and subsequently 
swallowed.
    Cadmium introduced into the body through inhalation or ingestion is 
transported by the albumin fraction of the blood plasma to the liver, 
where it accumulates and is stored principally as a bound form complexed 
with the protein metallothionein. Metallothionein-bound cadmium is the 
main form of cadmium subsequently transported to the kidney; it is these 
2 organs, the liver and kidney, in which the majority of the cadmium 
body burden accumulates. As much as one half of the total body burden of 
cadmium may be found in the kidneys (Nordberg and Nordberg 1988).
    Once cadmium has entered the body, elimination is slow; about 0.02% 
of the body burden is excreted per day via urinary/fecal elimination. 
The whole-body half-life of cadmium is 10-35 years, decreasing slightly 
with increasing age (Travis and Haddock 1980).
    The continual accumulation of cadmium is the basis for its chronic 
noncarcinogenic toxicity. This accumulation makes the kidney the target 
organ in which cadmium toxicity usually is first observed (Piscator 
1964). Renal damage may occur when cadmium levels in the kidney cortex 
approach 200 [micro]g/g wet tissue-weight (Travis and Haddock 1980).
    The kinetics and internal distribution of cadmium in the body are 
complex, and depend on whether occupational exposure to cadmium is 
ongoing or has terminated. In general, cadmium in blood is related 
principally to recent cadmium exposure, while cadmium in urine reflects 
cumulative exposure (i.e., total body burden) (Lauwerys et al. 1976; 
Friberg and Elinder 1988).

                           4.1 Health Effects

    Studies of workers in a variety of industries indicate that chronic 
exposure to cadmium may be linked to several adverse health effects 
including kidney dysfunction, reduced pulmonary function, chronic lung 
disease and cancer (Federal Register 1990). The primary sites for 
cadmium-associated cancer appear to be the lung and the prostate.
    Cancer. Evidence for an association between cancer and cadmium 
exposure comes from both epidemiological studies and animal experiments. 
Pott (1965) found a statistically significant elevation in the incidence

[[Page 195]]

of prostate cancer among a cohort of cadmium workers. Other epidemiology 
studies also report an elevated incidence of prostate cancer; however, 
the increases observed in these other studies were not statistically 
significant (Meridian Research, Inc. 1989).
    One study (Thun et al. 1985) contains sufficiently quantitative 
estimates of cadmium exposure to allow evaluation of dose-response 
relationships between cadmium exposure and lung cancer. A statistically 
significant excess of lung cancer attributed to cadmium exposure was 
found in this study, even after accounting for confounding variables 
such as coexposure to arsenic and smoking habits (Meridian Research, 
Inc. 1989).
    Evidence for quantifying a link between lung cancer and cadmium 
exposure comes from a single study (Takenaka et al. 1983). In this 
study, dose-response relationships developed from animal data were 
extrapolated to humans using a variety of models. OSHA chose the 
multistage risk model for estimating the risk of cancer for humans using 
these animal data. Animal injection studies also suggest an association 
between cadmium exposure and cancer, particularly observations of an 
increased incidence of tumors at sites remote from the point of 
injection. The International Agency for Research on Cancer (IARC) 
(Supplement 7, 1987) indicates that this, and related, evidence is 
sufficient to classify cadmium as an animal carcinogen. However, the 
results of these injection studies cannot be used to quantify risks 
attendant to human occupational exposures due to differences in routes 
of exposure (Meridian Research, Inc. 1989).
    Based on the above-cited studies, the U.S. Environmental Protection 
Agency (EPA) classifies cadmium as ``B1,'' a probable human carcinogen 
(USEPA 1985). IARC in 1987 recommended that cadmium be listed as a 
probable human carcinogen.
    Kidney Dysfunction. The most prevalent nonmalignant effect observed 
among workers chronically exposed to cadmium is kidney dysfunction. 
Initially, such dysfunction is manifested by proteinuria (Meridian 
Research, Inc. 1989; Roth Associates, Inc. 1989). Proteinuria associated 
with cadmium exposure is most commonly characterized by excretion of 
low-molecular weight proteins (15,000-40,000 MW), accompanied by loss of 
electrolytes, uric acid, calcium, amino acids, and phosphate. Proteins 
commonly excreted include [beta]-2-microglobulin (B2M), retinol-binding 
protein (RBP), immunoglobulin light chains, and lysozyme. Excretion of 
low molecular weight proteins is characteristic of damage to the 
proximal tubules of the kidney (Iwao et al. 1980).
    Exposure to cadmium also may lead to urinary excretion of high-
molecular weight proteins such as albumin, immunoglobulin G, and 
glycoproteins (Meridian Research, Inc. 1989; Roth Associates, Inc. 
1989). Excretion of high-molecular weight proteins is indicative of 
damage to the glomeruli of the kidney. Bernard et al. (1979) suggest 
that cadmium-associated damage to the glomeruli and damage to the 
proximal tubules of the kidney develop independently of each other, but 
may occur in the same individual.
    Several studies indicate that the onset of low-molecular weight 
proteinuria is a sign of irreversible kidney damage (Friberg et al. 
1974; Roels et al. 1982; Piscator 1984; Elinder et al. 1985; Smith et 
al. 1986). For many workers, once sufficiently elevated levels of B2M 
are observed in association with cadmium exposure, such levels do not 
appear to return to normal even when cadmium exposure is eliminated by 
removal of the worker from the cadmium-contaminated work environment 
(Friberg, exhibit 29, 1990).
    Some studies indicate that cadmium-induced proteinuria may be 
progressive; levels of B2MU increase even after cadmium exposure has 
ceased (Elinder et al. 1985). Other researchers have reached similar 
conclusions (Frieburg testimony, OSHA docket exhibit 29, Elinder 
testimony, OSHA docket exhibit 55, and OSHA docket exhibits 8-86B). Such 
observations are not universal, however (Smith et al. 1986; Tsuchiya 
1976). Studies in which proteinuria has not been observed, however, may 
have initiated the reassessment too early (Meridian Research, Inc.1989; 
Roth Associates, Inc. 1989; Roels 1989).
    A quantitative assessment of the risks of developing kidney 
dysfunction as a result of cadmium exposure was performed using the data 
from Ellis et al. (1984) and Falck et al. (1983). Meridian Research, 
Inc. (1989) and Roth Associates, Inc. (1989) employed several 
mathematical models to evaluate the data from the 2 studies, and the 
results indicate that cumulative cadmium exposure levels between 5 and 
100 [micro]g-years/m\3\ correspond with a one-in-a-thousand probability 
of developing kidney dysfunction.
    When cadmium exposure continues past the onset of early kidney 
damage (manifested as proteinuria), chronic nephrotoxicity may occur 
(Meridian Research, Inc. 1989; Roth Associates, Inc. 1989). Uremia, 
which is the loss of the glomerulus' ability to adequately filter blood, 
may result. This condition leads to severe disturbance of electrolyte 
concentrations, which may result in various clinical complications 
including atherosclerosis, hypertension, pericarditis, anemia, 
hemorrhagic tendencies, deficient cellular immunity, bone changes, and 
other problems. Progression of the disease may require dialysis or a 
kidney transplant.
    Studies in which animals are chronically exposed to cadmium confirm 
the renal effects observed in humans (Friberg et al. 1986). Animal 
studies also confirm cadmium-related problems with calcium metabolism 
and associated skeletal effects, which also

[[Page 196]]

have been observed among humans. Other effects commonly reported in 
chronic animal studies include anemia, changes in liver morphology, 
immunosuppression and hypertension. Some of these effects may be 
associated with cofactors; hypertension, for example, appears to be 
associated with diet, as well as with cadmium exposure. Animals injected 
with cadmium also have shown testicular necrosis.

                  4.2 Objectives for Medical Monitoring

    In keeping with the observation that renal disease tends to be the 
earliest clinical manifestation of cadmium toxicity, the final cadmium 
standard mandates that eligible workers must be medically monitored to 
prevent this condition (as well as cadmimum-induced cancer). The 
objectives of medical-monitoring, therefore, are to: Identify workers at 
significant risk of adverse health effects from excess, chronic exposure 
to cadmium; prevent future cases of cadmium-induced disease; detect and 
minimize existing cadmium-induced disease; and, identify workers most in 
need of medical intervention.
    The overall goal of the medical monitoring program is to protect 
workers who may be exposed continuously to cadmium over a 45-year 
occupational lifespan. Consistent with this goal, the medical monitoring 
program should assure that:
    1. Current exposure levels remain sufficiently low to prevent the 
accumulation of cadmium body burdens sufficient to cause disease in the 
future by monitoring CDB as an indicator of recent cadmium exposure;
    2. Cumulative body burdens, especially among workers with undefined 
historical exposures, remain below levels potentially capable of leading 
to damage and disease by assessing CDU as an indicator of cumulative 
exposure to cadmium; and,
    3. Health effects are not occurring among exposed workers by 
determining B2MU as an early indicator of the onset of cadmium-induced 
kidney disease.

             4.3 Indicators of Cadmium Exposure and Disease

    Cadmium is present in whole blood bound to albumin, in erythrocytes, 
and as a metallothionein-cadmium complex. The metallothionein-cadmium 
complex that represents the primary transport mechanism for cadmium 
delivery to the kidney. CDB concentrations in the general, nonexposed 
population average 1 [micro]g Cd/l whole blood, with smokers exhibiting 
higher levels (see Section 5.1.6). Data presented in Section 5.1.6 shows 
that 95% of the general population not occupationally exposed to cadmium 
have CDB levels less than 5 [micro]g Cd/l.
    If total body burdens of cadmium remain low, CDB concentrations 
indicate recent exposure (i.e., daily intake). This conclusion is based 
on data showing that cigarette smokers exhibit CDB concentrations of 2-7 
[micro]g/l depending on the number of cigarettes smoked per day 
(Nordberg and Nordberg 1988), while CDB levels for those who quit 
smoking return to general population values (approximately 1 [micro]g/l) 
within several weeks (Lauwerys et al. 1976). Based on these 
observations, Lauwerys et al. (1976) concluded that CDB has a biological 
half-life of a few weeks to less than 3 months. As indicated in Section 
3.1.6, the upper 95th percentile for CDB levels observed among those who 
are not occupationally exposed to cadmium is 5 [micro]g/l, which 
suggests that the absolute upper limit to the range reported for smokers 
by Nordberg and Nordberg may have been affected by an extreme value 
(i.e., beyond 2[sigma] above the mean).
    Among occupationally-exposed workers, the occupational history of 
exposure to cadmium must be evaluated to interpret CDB levels. New 
workers, or workers with low exposures to cadmium, exhibit CDB levels 
that are representative of recent exposures, similar to the general 
population. However, for workers with a history of chronic exposure to 
cadmium, who have accumulated significant stores of cadmium in the 
kidneys/liver, part of the CDB concentrations appear to indicate body 
burden. If such workers are removed from cadmium exposure, their CDB 
levels remain elevated, possibly for years, reflecting prior long-term 
accumulation of cadmium in body tissues. This condition tends to occur, 
however, only beyond some threshold exposure value, and possibly 
indicates the capacity of body tissues to accumulate cadmium which 
cannot be excreted readily (Friberg and Elinder 1988; Nordberg and 
Nordberg 1988).
    CDU is widely used as an indicator of cadmium body burdens (Nordberg 
and Nordberg 1988). CDU is the major route of elimination and, when CDU 
is measured, it is commonly expressed either as [micro]g Cd/l urine 
(unadjusted), [micro]g Cd/l urine (adjusted for specific gravity), or 
[micro]g Cd/g CRTU (see Section 5.2.1). The metabolic model for CDU is 
less complicated than CDB, since CDU is dependentin large part on the 
body (i.e., kidney) burden of cadmium. However, a small proportion of 
CDU still be attributed to recent cadmium exposure, particularly if 
exposure to high airborne concentrations of cadmium occurred. Note that 
CDU is subject to larger interindividual and day-to-day variations than 
CDB, so repeated measurements are recommended for CDU evaluations.
    CDU is bound principally to metallothionein, regardless of whether 
the cadmium originates from metallothionein in plasma or from the 
cadmium pool accumulated in the renal tubules. Therefore, measurement of 
metallothionein in urine may provide information similar to CDU, while 
avoiding the contamination problems that

[[Page 197]]

may occur during collection and handling urine for cadmium analysis 
(Nordberg and Nordberg 1988). However, a commercial method for the 
determination of metallothionein at the sensitivity levels required 
under the final cadmium rule is not currently available; therefore, 
analysis of CDU is recommended.
    Among the general population not occupationally exposed to cadmium, 
CDU levels average less than 1 [micro]g/l (see Section 5.2.7). 
Normalized for creatinine (CRTU), the average CDU concentration of the 
general population is less than 1 [micro]g/g CRTU. As cadmium 
accumulates over the lifespan, CDU increases with age. Also, cigarette 
smokers may eventually accumulate twice the cadmium body burden of 
nonsmokers, CDU is slightly higher in smokers than in nonsmokers, even 
several years after smoking cessation (Nordberg and Nordberg 1988). 
Despite variations due to age and smoking habits, 95% of those not 
occupationally exposed to cadmium exhibit levels of CDU less than 3 
[micro]g/g CRTU (based on the data presented in Section 5.2.7).
    About 0.02% of the cadmium body burden is excreted daily in urine. 
When the critical cadmium concentration (about 200 ppm) in the kidney is 
reached, or if there is sufficient cadmium-induced kidney dysfunction, 
dramatic increases in CDU are observed (Nordberg and Nordberg 1988). 
Above 200 ppm, therefore, CDU concentrations cease to be an indicator of 
cadmium body burden, and are instead an index of kidney failure.
    Proteinuria is an index of kidney dysfunction, and is defined by 
OSHA to be a material impairment. Several small proteins may be 
monitored as markers for proteinuria. Below levels indicative of 
proteinuria, these small proteins may be early indicators of increased 
risk of cadmium-induced renal tubular disease. Analytes useful for 
monitoring cadmium-induced renal tubular damage include:
    1. [beta]-2-Microglobulin (B2M), currently the most widely used 
assay for detecting kidney dysfunction, is the best characterized 
analyte available (Iwao et al. 1980; Chia et al. 1989);
    2. Retinol Binding Protein (RBP) is more stable than B2M in acidic 
urine (i.e., B2M breakdown occurs if urinary pH is less than 5.5; such 
breakdown may result in false [i.e., low] B2M values [Bernard and 
Lauwerys, 1990]);
    3. N-Acetyl-B-Glucosaminidase (NAG) is the analyte of an assay that 
is simple, inexpensive, reliable, and correlates with cadmium levels 
under 10 [micro]g/g CRTU, but the assay is less sensitive than RBP or 
B2M (Kawada et al. 1989);
    4. Metallothionein (MT) correlates with cadmium and B2M levels, and 
may be a better predictor of cadmium exposure than CDU and B2M (Kawada 
et al. 1989);
    5. Tamm-Horsfall Glycoprotein (THG) increases slightly with elevated 
cadmium levels, but this elevation is small compared to increases in 
urinary albumin, RBP, or B2M (Bernard and Lauwerys 1990);
    6. Albumin (ALB), determined by the biuret method, is not 
sufficiently sensitive to serve as an early indicator of the onset of 
renal disease (Piscator 1962);
    7. Albumin (ALB), determined by the Amido Black method, is sensitive 
and reproducible, but involves a time-consuming procedure (Piscator 
1962);
    8. Glycosaminoglycan (GAG) increases among cadmium workers, but the 
significance of this effect is unknown because no relationship has been 
found between elevated GAG and other indices of tubular damage (Bernard 
and Lauwerys 1990);
    9. Trehalase seems to increase earlier than B2M during cadmium 
exposure, but the procedure for analysis is complicated and unreliable 
(Iwata et al. 1988); and,
    10. Kallikrein is observed at lower concentrations among cadmium-
exposed workers than among normal controls (Roels et al. 1990).
    Of the above analytes, B2M appears to be the most widely used and 
best characterized analyte to evaluate the presence/absence, as well as 
the extent of, cadmium-induced renal tubular damage (Kawada, Koyama, and 
Suzuki 1989; Shaikh and Smith 1984; Nogawa 1984). However, it is 
important that samples be collected and handled so as to minimize B2M 
degradation under acidic urine conditions.
    The threshold value of B2MU commonly used to indicate the presence 
of kidney damage 300 [micro]g/g CRTU (Kjellstrom et al. 1977a; Buchet et 
al. 1980; and Kowal and Zirkes 1983). This value represents the upper 
95th or 97.5th percentile level of urinary excretion observed among 
those without tubular dysfunction (Elinder, exbt L-140-45, OSHA docket 
H057A). In agreement with these conclusions, the data presented in 
Section 5.3.7 of this protocol generally indicate that the level of 300 
[micro]g/g CRTU appears to define the boundary for kidney dysfunction. 
It is not clear, however, that this level represents the upper 95th 
percentile of values observed among those who fail to demonstrate 
proteinuria effects.
    Although elevated B2MU levels appear to be a fairly specific 
indicator of disease associated with cadmium exposure, other conditions 
that may lead to elevated B2MU levels include high fevers from 
influenza, extensive physical exercise, renal disease unrelated to 
cadmium exposure, lymphomas, and AIDS (Iwao et al. 1980; Schardun and 
van Epps 1987). Elevated B2M levels observed in association with high 
fevers from influenza or from extensive physical exercise are transient, 
and will return to normal levels once

[[Page 198]]

the fever has abated or metabolic rates return to baseline values 
following exercise. The other conditions linked to elevated B2M levels 
can be diagnosed as part of a properly-designed medical examination. 
Consequently, monitoring B2M, when accompanied by regular medical 
examinations and CDB and CDU determinations (as indicators of present 
and past cadmium exposure), may serve as a specific, early indicator of 
cadmium-induced kidney damage.

         4.4 Criteria for Medical Monitoring of Cadmium Workers

    Medical monitoring mandated by the final cadmium rule includes a 
combination of regular medical examinations and periodic monitoring of 3 
analytes: CDB, CDU and B2MU. As indicated above, CDB is monitored as an 
indicator of current cadmium exposure, while CDU serves as an indicator 
of the cadmium body burden; B2MU is assessed as an early marker of 
irreversible kidney damage and disease.
    The final cadmium rule defines a series of action levels that have 
been developed for each of the 3 analytes to be monitored. These action 
levels serve to guide the responsible physician through a decision-
making process. For each action level that is exceeded, a specific 
response is mandated. The sequence of action levels, and the attendant 
actions, are described in detail in the final cadmium rule.
    Other criteria used in the medical decision-making process relate to 
tests performed during the medical examination (including a 
determination of the ability of a worker to wear a respirator). These 
criteria, however, are not affected by the results of the analyte 
determinations addressed in the above paragraphs and, consequently, will 
not be considered further in these guidelines.

  4.5 Defining to Quality and Proficiency of the Analyte Determinations

    As noted above in Sections 2 and 3, the quality of a measurement 
should be defined along with its value to properly interpret the 
results. Generally, it is necessary to know the accuracy and the 
precision of a measurement before it can be properly evaluated. The 
precision of the data from a specific laboratory indicates the extent to 
which the repeated measurements of the same sample vary within that 
laboratory. The accuracy of the data provides an indication of the 
extent to which these results deviate from average results determined 
from many laboratories performing the same measurement (i.e., in the 
absence of an independent determination of the true value of a 
measurement). Note that terms are defined operationally relative to the 
manner in which they will be used in this protocol. Formal definitions 
for the terms in italics used in this section can be found in the list 
of definitions (Section 2).
    Another data quality criterion required to properly evaluate 
measurement results is the limit of detection of that measurement. For 
measurements to be useful, the range of the measurement which is of 
interest for biological monitoring purposes must lie entirely above the 
limit of detection defined for that measurement.
    The overall quality of a laboratory's results is termed the 
performance of that laboratory. The degree to which a laboratory 
satisfies a minimum performance level is referred to as the proficiency 
of the laboratory. A successful medical monitoring program, therefore, 
should include procedures developed for monitoring and recording 
laboratory performance; these procedures can be used to identify the 
most proficient laboratories.

  5.0 Overview of Medical Monitoring Tests for CDB, CDU, B2MU and CRTU

    To evaluate whether available methods for assessing CDB, CDU, B2MU 
and CRTU are adequate for determining the parameters defined by the 
proposed action levels, it is necessary to review procedures available 
for sample collection, preparation and analysis. A variety of techniques 
for these purposes have been used historically for the determination of 
cadmium in biological matrices (including CDB and CDU), and for the 
determination of specific proteins in biological matrices (including 
B2MU). However, only the most recent techniques are capable of 
satisfying the required accuracy, precision and sensitivity (i.e., limit 
of detection) for monitoring at the levels mandated in the final cadmium 
rule, while still facilitating automated analysis and rapid processing.

                  5.1 Measuring Cadmium in Blood (CDB)

    Analysis of biological samples for cadmium requires strict 
analytical discipline regarding collection and handling of samples. In 
addition to occupational settings, where cadmium contamination would be 
apparent, cadmium is a ubiquitous environmental contaminant, and much 
care should be exercised to ensure that samples are not contaminated 
during collection, preparation or analysis. Many common chemical 
reagents are contaminated with cadmium at concentrations that will 
interfere with cadmium analysis; because of the widespread use of 
cadmium compounds as colored pigments in plastics and coatings, the 
analyst should continually monitor each manufacturer's chemical reagents 
and collection containers to prevent contamination of samples.
    Guarding against cadmium contamination of biological samples is 
particularly important when analyzing blood samples because cadmium 
concentrations in blood samples

[[Page 199]]

from nonexposed populations are generally less than 2 [micro]g/l (2 ng/
ml), while occupationally-exposed workers can be at medical risk to 
cadmium toxicity if blood concentrations exceed 5 [micro]g/l (ACGIH 1991 
and 1992). This narrow margin between exposed and unexposed samples 
requires that exceptional care be used in performing analytic 
determinations for biological monitoring for occupational cadmium 
exposure.
    Methods for quantifying cadmium in blood have improved over the last 
40 years primarily because of improvements in analytical 
instrumentation. Also, due to improvements in analytical techniques, 
there is less need to perform extensive multi-step sample preparations 
prior to analysis. Complex sample preparation was previously required to 
enhance method sensitivity (for cadmium), and to reduce interference by 
other metals or components of the sample.

   5.1.1 Analytical Techniques Used To Monitor Cadmium in Biological 
                                Matrices

 Table 3--Comparison of Analytical Procedures/Instrumentation for Determination of Cadmium in Biological Samples
----------------------------------------------------------------------------------------------------------------
                            Limit of
  Analytical procedure   detection [ng/    Specified biological          Reference                Comments
                           (g or ml)]             matrix
----------------------------------------------------------------------------------------------------------------
Flame Atomic Absorption  =1.  Any matrix.............  Perkin-Elmer (1982)....  Not sensitive enough
 Spectroscopy (FAAS).              0                                                        for biomonitoring
                                                                                            without extensive
                                                                                            sample digestion,
                                                                                            metal chelation and
                                                                                            organic solvent
                                                                                            extraction.
Graphite Furnace Atomic            0.04  Urine..................  Pruszkowska et al.       Methods of choice for
 Absorption                                                        (1983).                  routine cadmium
 Spectroscopy (GFAAS).                                                                      analysis.
                         =0.  Blood..................  Stoeppler and Brandt
                                  20                               (1980).
Inductively-Coupled                2.0   Any matrix.............  NIOSH (1984A)..........  Requires extensive
 Argon-Plasma Atomic                                                                        sample preparation
 Emission Spectroscopy                                                                      and concentration of
 (ICAP AES).                                                                                metal with chelating
                                                                                            resin. Advantage is
                                                                                            simultaneous
                                                                                            analyses for as many
                                                                                            as 10 metals from 1
                                                                                            sample.
Neutron Activation                 1.5   In vivo (liver)........  Ellis et al. (1983)....  Only available in
 Gamma Spectroscopy                                                                         vivo method for
 (NA).                                                                                      direct determination
                                                                                            of cadmium body
                                                                                            tissue burdens;
                                                                                            expensive; absolute
                                                                                            determination of
                                                                                            cadmium in reference
                                                                                            materials.
Isotope Dilution Mass             <1.0   Any matrix.............  Michiels and DeBievre    Suitable for absolute
 Spectroscopy (IDMS).                                              (1986).                  determination of
                                                                                            cadmium in reference
                                                                                            materials;
                                                                                            expensive.
Differential Pulse                <1.0   Any matrix.............  Stoeppler and Brandt     Suitable for absolute
 Anodic Stripping                                                  (1980).                  determination of
 Voltammetry (DPASV).                                                                       cadmium in reference
                                                                                            materials; efficient
                                                                                            method to check
                                                                                            accuracy of
                                                                                            analytical method.
----------------------------------------------------------------------------------------------------------------

    A number of analytical techniques have been used for determining 
cadmium concentrations in biological materials. A summary of the 
characteristics of the most widely employed techniques is presented in 
Table 3. The technique most suitable for medical monitoring for cadmium 
is atomic absorption spectroscopy (AAS).
    To obtain a measurement using AAS, a light source (i.e., hollow 
cathode or lectrode-free discharge lamp) containing the element of 
interest as the cathode, is energized and the lamp emits a spectrum that 
is unique for that element. This light source is focused through a 
sample cell, and a selected wavelength is monitored by a monochrometer 
and photodetector cell. Any ground state atoms in the sample that match 
those of the lamp element and are in the path of the emitted light may 
absorb some of the light and decrease the amount of light that reaches 
the photodetector cell. The amount of light absorbed at each 
characteristic wavelength is proportional to the number of ground state 
atoms of the corresponding element that are in the pathway of the light 
between the source and detector.
    To determine the amount of a specific metallic element in a sample 
using AAS, the sample is dissolved in a solvent and aspirated into a 
high-temperature flame as an aerosol. At high temperatures, the solvent 
is rapidly evaporated or decomposed and the solute is initially 
solidified; the majority of the sample elements then are transformed 
into an atomic vapor. Next, a light beam is focused above the flame and 
the amount of metal in the sample can be determined by measuring the 
degree of absorbance of the atoms of the target element released by the 
flame at a characteristic wavelength.
    A more refined atomic absorption technique, flameless AAS, 
substitutes an electrothermal, graphite furnace for the

[[Page 200]]

flame. An aliquot (10-100 [micro]l) of the sample is pipetted into the 
cold furnace, which is then heated rapidly to generate an atomic vapor 
of the element.
    AAS is a sensitive and specific method for the elemental analysis of 
metals; its main drawback is nonspecific background absorbtion and 
scattering of the light beam by particles of the sample as it decomposes 
at high temperatures; nonspecific absorbance reduces the sensitivity of 
the analytical method. The problem of nonspecific absorbance and 
scattering can be reduced by extensive sample pretreatment, such as 
ashing and/or acid digestion of the sample to reduce its organic 
content.
    Current AAS instruments employ background correction devices to 
adjust electronically for background absorbtion and scattering. A common 
method to correct for background effects is to use a deuterium arc lamp 
as a second light source. A continuum light source, such as the 
deuterium lamp, emits a broad spectrum of wavelengths instead of 
specific wavelengths characteristic of a particular element, as with the 
hollow cathode tube. With this system, light from the primary source and 
the continuum source are passed alternately through the sample cell. The 
target element effectively absorbs light only from the primary source 
(which is much brighter than the continuum source at the characteristic 
wavelengths), while the background matrix absorbs and scatters light 
from both sources equally. Therefore, when the ratio of the two beams is 
measured electronically, the effect of nonspecific background absorption 
and scattering is eliminated. A less common, but more sophisticated, 
backgrond correction system is based on the Zeeman effect, which uses a 
magnetically-activated light polarizer to compensate electronically for 
nonspecific absorbtion and scattering.
    Atomic emission spectroscopy with inductively-coupled argon plasma 
(AES-ICAP) is widely used to analyze for metals. With this instrument, 
the sample is aspirated into an extremely hot argon plasma flame, which 
excites the metal atoms; emission spectra specific for the sample 
element then are generated. The quanta of emitted light passing through 
a monochrometer are amplified by photomultiplier tubes and measured by a 
photodetector to determine the amount of metal in the sample. An 
advantage of AES-ICAP over AAS is that multi-elemental analyses of a 
sample can be performed by simultaneously measuring specific elemental 
emission energies. However, AES-ICAP lacks the sensitivity of AAS, 
exhibiting a limit of detection which is higher than the limit of 
detection for graphite-furnace AAS (Table 3).
    Neutron activation (NA) analysis and isotope dilution mass 
spectrometry (IDMS) are 2 additional, but highly specialized, methods 
that have been used for cadmium determinations. These methods are 
expensive because they require elaborate and sophisticated 
instrumentation.
    NA analysis has the distinct advantage over other analytical methods 
of being able to determine cadmium body burdens in specific organs 
(e.g., liver, kidney) in vivo (Ellis et al. 1983). Neutron bombardment 
of the target transforms cadmium-113 to cadmium-114, which promptly 
decays (<10-14 sec) to its ground state, emitting gamma rays 
that are measured using large gamma detectors; appropriate shielding and 
instrumentation are required when using this method.
    IDMS analysis, a definitive but laborious method, is based on the 
change in the ratio of 2 isotopes of cadmium (cadmium 111 and 112) that 
occurs when a known amount of the element (with an artificially altered 
ratio of the same isotopes [i.e., a cadmium 111 ``spike''] is added to a 
weighed aliquot of the sample (Michiels and De Bievre 1986).

             5.1.2 Methods Developed for CDB Determinations

    A variety of methods have been used for preparing and analyzing CDB 
samples; most of these methods rely on one of the analytical techniques 
described above. Among the earliest reports, Princi (1947) and Smith et 
al. (1955) employed a colorimetric procedure to analyze for CDB and CDU. 
Samples were dried and digested through several cycles with concentrated 
mineral acids (HNO3 and H2 SO4) and 
hydrogen peroxide (H2 O2). The digest was 
neutralized, and the cadmium was complexed with diphenylthiocarbazone 
and extracted with chloroform. The dithizone-cadmium complex then was 
quantified using a spectrometer.
    Colorimetric procedures for cadmium analyses were replaced by 
methods based on atomic absorption spectroscopy (AAS) in the early 
1960s, but many of the complex sample preparation procedures were 
retained. Kjellstrom (1979) reports that in Japanese, American and 
Swedish laboratories during the early 1970s, blood samples were wet 
ashed with mineral acids or ashed at high temperature and wetted with 
nitric acid. The cadmium in the digest was complexed with metal 
chelators including diethyl dithiocarbamate (DDTC), ammonium pyrrolidine 
dithiocarbamate (APDC) or diphenylthiocarbazone (dithizone) in ammonia-
citrate buffer and extracted with methyl isobutyl ketone (MIBK). The 
resulting solution then was analyzed by flame AAS or graphite-furnace 
AAS forcadmium determinations using deuterium-lamp background 
correction.
    In the late 1970s, researchers began developing simpler preparation 
procedures. Roels et al. (1978) and Roberts and Clark (1986) developed 
simplified digestion procedures. Using the Roberts and Clark method, a 
0.5

[[Page 201]]

ml aliquot of blood is collected and transferred to a digestion tube 
containing 1 ml concentrated HNO3. The blood is then digested 
at 110 [deg]C for 4 hours. The sample is reduced in volume by continued 
heating, and 0.5 ml 30% H2 O2 is added as the 
sample dries. The residue is dissolved in 5 ml dilute (1%) 
HNO3, and 20 [micro]l of sample is then analyzed by graphite-
furnace AAS with deuterium-background correction.
    The current trend in the preparation of blood samples is to dilute 
the sample and add matrix modifiers to reduce background interference, 
rather than digesting the sample to reduce organic content. The method 
of Stoeppler and Brandt (1980), and the abbreviated procedure published 
in the American Public Health Association's (APHA) Methods for 
Biological Monitoring (1988), are straightforward and are nearly 
identical. For the APHA method, a small aliquot (50-300 [micro]l) of 
whole blood that has been stabilized with ethylenediaminetetraacetate 
(EDTA) is added to 1.0 ml 1MHNO3, vigorously shaken and 
centrifuged. Aliquots (10-25 [micro]l) of the supernatant then are then 
analyzed by graphite-furnace AAS with appropriate background correction.
    Using the method of Stoeppler and Brandt (1980), aliquots (50-200 
[micro]l) of whole blood that have been stabilized with EDTA are 
pipetted into clean polystyrene tubes and mixed with 150-600 [micro]l of 
1 M HNO3. After vigorous shaking, the solution is centrifuged 
and a 10-25 [micro]l aliquot of the supernatant then is analyzed by 
graphite-furnace AAS with appropriate background correction.
    Claeys-Thoreau (1982) and DeBenzo et al. (1990) diluted blood 
samples at a ratio of 1:10 with a matrix modifier (0.2% Triton X-100, a 
wetting agent) for direct determinations of CDB. DeBenzo et al. also 
demonstrated that aqueous standards of cadmium, instead of spiked, 
whole-blood samples, could be used to establish calibration curves if 
standards and samples are treated with additional small volumes of 
matrix modifiers (i.e., 1% HNO3, 0.2% ammonium 
hydrogenphosphate and 1 mg/ml magnesium salts).
    These direct dilution procedures for CDB analysis are simple and 
rapid. Laboratories can process more than 100 samples a day using a 
dedicated graphite-furnace AAS, an auto-sampler, and either a Zeeman- or 
a deuterium-background correction system. Several authors emphasize 
using optimum settings for graphite-furnace temperatures during the 
drying, charring, and atomization processes associated with the 
flameless AAS method, and the need to run frequent QC samples when 
performing automated analysis.

                  5.1.3 Sample Collection and Handling

    Sample collection procedures are addressed primarily to identify 
ways to minimize the degree of variability that may be introduced by 
sample collection during medical monitoring. It is unclear at this point 
the extent to which collection procedures contribute to variability 
among CDB samples. Sources of variation that may result from sampling 
procedures include time-of-day effects and introduction of external 
contamination during the collection process. To minimize these sources, 
strict adherence to a sample collection protocol is recommended. Such a 
protocol must include provisions for thorough cleaning of the site from 
which blood will be extracted; also, every effort should be made to 
collect samples near the same time of day. It is also important to 
recognize that under the recent OSHA blood-borne pathogens standard (29 
CFR 1910.1030), blood samples and certain body fluids must be handled 
and treated as if they are infectious.

                    5.1.4 Best Achievable Performance

    The best achievable performance using a particular method for CDB 
determinations is assumed to be equivalent to the performance reported 
by research laboratories in which the method was developed.
    For their method, Roberts and Clark (1986) demonstrated a limit of 
detection of 0.4 [micro]g Cd/l in whole blood, with a linear response 
curve from 0.4 to 16.0 [micro]g Cd/l. They report a coefficient of 
variation (CV) of 6.7% at 8.0 [micro]g/l.
    The APHA (1988) reports a range of 1.0-25 [micro]g/l, with a CV of 
7.3% (concentration not stated). Insufficient documentation was 
available to critique this method.
    Stoeppler and Brandt (1980) achieved a detection limit of 0.2 
[micro]g Cd/l whole blood, with a linear range of 0.4-12.0 [micro]g Cd/
l, and a CV of 15-30%, for samples at <1.0 [micro]g/l. Improved 
precision (CV of 3.8%) was reported for CDB concentrations at 9.3 
[micro]g/l.

                    5.1.5 General Method Performance

    For any particular method, the performance expected from commercial 
laboratories may be somewhat lower than that reported by the research 
laboratory in which the method was developed. With participation in 
appropriate proficiency programs and use of a proper in-house QA/QC 
program incorporating provisions for regular corrective actions, the 
performance of commercial laboratories is expected to approach that 
reported by research laboratories. Also, the results reported for 
existing proficiency programs serve as a gauge of the likely level of 
performance that currently can be expected from commercial laboratories 
offering these analyses.
    Weber (1988) reports on the results of the proficiency program run 
by the Centre de Toxicologie du Quebec (CTQ). As indicated previously, 
participants in that program receive 18 blood samples per year having 
cadmium concentrations ranging from 0.2-20 [micro]g/

[[Page 202]]

l. Currently, 76 laboratories are participating in this program. The 
program is established for several analytes in addition to cadmium, and 
not all of these laboratories participate in the cadmium proficiency-
testing program.
    Under the CTQ program, cadmium results from individual laboratories 
are compared against the consensus mean derived for each sample. Results 
indicate that after receiving 60 samples (i.e., after participation for 
approximately three years), 60% of the laboratories in the program are 
able to report results that fall within 1 
[micro]g/l or 15% of the mean, whichever is greater. (For this 
procedure, the 15% criterion was applied to concentrations exceeding 7 
[micro]g/l.) On any single sample of the last 20 samples, the percentage 
of laboratories falling within the specified range is between 55 and 
80%.
    The CTQ also evaluates the performance of participating laboratories 
against a less severe standard: 2 [micro]g/l or 
15% of the mean, whichever is greater (Weber 1988); 90% of participating 
laboratories are able to satisfy this standard after approximately 3 
years in the program. (The 15% criterion is used for concentrations in 
excess of 13 [micro]g/l.) On any single sample of the last 15 samples, 
the percentage of laboratories falling within the specified range is 
between 80 and 95% (except for a single test for which only 60% of the 
laboratories achieved the desired performance).
    Based on the data presented in Weber (1988), the CV for analysis of 
CDB is nearly constant at 20% for cadmium concentrations exceeding 5 
[micro]g/l, and increases for cadmium concentrations below 5 [micro]g/l. 
At 2 [micro]g/l, the reported CV rises to approximately 40%. At 1 
[micro]g/l, the reported CV is approximately 60%.
    Participating laboratories also tend to overestimate concentrations 
for samples exhibiting concentrations less than 2 [micro]g/l (see Figure 
11 of Weber 1988). This problem is due in part to the proficiency 
evaluation criterion that allows reporting a minimum 2.0 [micro]g/l for evaluated CDB samples. There is 
currently little economic or regulatory incentive for laboratories 
participating in the CTQ program to achieve greater accuracy for CDB 
samples containing cadmium at concentrations less than 2.0 [micro]g/l, 
even if the laboratory has the experience and competency to distinguish 
among lower concentrations in the samples obtained from the CTQ.
    The collective experience of international agencies and 
investigators demonstrate the need for a vigorous QC program to ensure 
that CDB values reported by participating laboratories are indeed 
reasonably accurate. As Friberg (1988) stated:

``Information about the quality of published data has often been 
lacking. This is of concern as assessment of metals in trace 
concentrations in biological media are fraught with difficulties from 
the collection, handling, and storage of samples to the chemical 
analyses. This has been proven over and over again from the results of 
interlaboratory testing and quality control exercises. Large variations 
in results were reported even from `experienced' laboratories.''

    The UNEP/WHO global study of cadmium biological monitoring set a 
limit for CDB accuracy using the maximum allowable deviation method at 
Y=X(0.1X+1) for a targeted concentration of 10 
[micro]g Cd/l (Friberg and Vahter 1983). The performance of 
participating laboratories over a concentration range of 1.5-12 
[micro]g/l was reported by Lind et al. (1987). Of the 3 QC runs 
conducted during 1982 and 1983, 1 or 2 of the 6 laboratories failed each 
run. For the years 1983 and 1985, between zero and 2 laboratories failed 
each of the consecutive QC runs.
    In another study (Vahter and Friberg 1988), QC samples consisting of 
both external (unknown) and internal (stated) concentrations were 
distributed to laboratories participating in the epidemiology research. 
In this study, the maximum acceptable deviation between the regression 
analysis of reported results and reference values was set at Y=X(0.05X+0.2) for a concentration range of 0.3-5.0 
[micro]g Cd/l. It is reported that only 2 of 5 laboratories had 
acceptable data after the first QC set, and only 1 of 5 laboratories had 
acceptable data after the second QC set. By the fourth QC set, however, 
all 5 laboratories were judged proficient.
    The need for high quality CDB monitoring is apparent when the 
toxicological and biological characteristics of this metal are 
considered; an increase in CDB from 2 to 4 [micro]g/l could cause a 
doubling of the cadmium accumulation in the kidney, a critical target 
tissue for selective cadmium accumulation (Nordberg and Nordberg 1988).
    Historically, the CDC's internal QC program for CDB cadmium 
monitoring program has found achievable accuracy to be 10% of the true value at CDB concentrations 
=5.0 [micro]g/l (Paschal 1990). Data on the performance of 
laboratories participating in this program currently are not available.

                    5.1.6 Observed CDB Concentrations

    As stated in Section 4.3, CDB concentrations are representative of 
ongoing levels of exposure to cadmium. Among those who have been exposed 
chronically to cadmium for extended periods, however, CDB may contain a 
component attributable to the general cadmium body burden.

           5.1.6.1 CDB Concentrations Among Unexposed Samples

    Numerous studies have been conducted examining CDB concentrations in 
the general population, and in control groups used for comparison with 
cadmium-exposed workers. A number of reports have been published that 
present erroneously high values of CDB

[[Page 203]]

(Nordberg and Nordberg 1988). This problem was due to contamination of 
samples during sampling and analysis, and to errors in analysis. Early 
AAS methods were not sufficiently sensitive to accurately estimate CDB 
concentrations.
    Table 4 presents results of recent studies reporting CDB levels for 
the general U.S. population not exposed occupationally to cadmium. Other 
surveys of tissue cadmium using U.S. samples and conducted as part of a 
cooperative effort among Japan, Sweden and the U.S., did not collect CDB 
data because standard analytical methodologies were unavailable, and 
because of analytic problems (Kjellstrom 1979; SWRI 1978).

[[Page 204]]



                                               Table 4--Blood Cadmium Concentrations of U.S. Population Not Occupationally Exposed to Cadmium \a\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Lower 95th    Upper 95th
                                                                                             Arithmetic mean    Absolute    Geometric mean    percentile    percentile
            Study No.               No. in        Sex            Age            Smoking     ( S.D.)     (95% CI)   thn-eq> GSD) \e\  distribution  distribution
                                                                                                   \c\            \d\                             \f\           \f\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1...............................          80  M           4 to 69..........  NS,S                    1.13       0.35-3.3      0.98
                                                                                                                                    1.71
                                          88  F           4 to 69..........  NS,S                    1.03       0.21-3.3      0.91
                                                                                                                                    1.63
                                         115  M/F         4 to 69..........  NS                      0.95       0.21-3.3      0.85
                                                                                                                                    1.59
                                          31  M/F         4 to 69..........  S                       1.54        0.4-3.3      1.37
                                                                                                                                    1.65
2...............................          10  M           Adults...........  (?)                2.0
                                                                                                      2.1
3...............................          24  M           Adults...........  NS             ................  ...........      0.6                               (1983).
                                                                                                                                    1/87
                                          20  M           Adults...........  S              ................  ...........      1.2
                                                                                                                                    2.13
                                          64  F           Adults...........  NS             ................  ...........      0.5
                                                                                                                                    1.85
                                          39  F           Adults...........  S              ................  ...........      0.8
                                                                                                                                    2.22
4...............................          32  M           Adults...........  S,NS           ................  ...........      1.2
                                                                                                                                     2.0
5...............................          35  M           Adults...........  (?)                2.1
                                                                                                      2.1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Concentrations reported in [micro]g Cd/l blood unless otherwise stated.
\b\ NS--never smoked; S--current cigarette smoker.
\c\ S.D.--Arithmetic Standard Deviation.
\d\ C.I.--Confidence interval.
\e\ GSD--Geometric Standard Deviation.
\f\ Based on an assumed lognormal distribution.
\g\ Based on an assumed normal distribution.


[[Page 205]]

    Arithmetic and/or geometric means and standard deviations are 
provided in Table 4 for measurements among the populations defined in 
each study listed. The range of reported measurements and/or the 95% 
upper and lower confidence intervals for the means are presented when 
this information was reported in a study. For studies reporting either 
an arithmetic or geometric standard deviation along with a mean, the 
lower and upper 95th percentile for the distribution also were derived 
and reported in the table.
    The data provided in table 4 from Kowal et al. (1979) are from 
studies conducted between 1974 and 1976 evaluating CDB levels for the 
general population in Chicago, and are considered to be representative 
of the U.S. population. These studies indicate that the average CDB 
concentration among those not occupationally exposed to cadmium is 
approximately 1 [micro]g/l.
    In several other studies presented in Table 4, measurements are 
reported separately for males and females, and for smokers and 
nonsmokers. The data in this table indicate that similar CDB levels are 
observed among males and females in the general population, but that 
smokers tend to exhibit higher CDB levels than nonsmokers. Based on the 
Kowal et al. (1979) study, smokers not occupationally exposed to cadmium 
exhibit an average CDB level of 1.4 [micro]g/l.
    In general, nonsmokers tend to exhibit levels ranging to 2 [micro]g/
l, while levels observed among smokers range to 5 [micro]g/l. Based on 
the data presented in Table 4, 95% of those not occupationally exposed 
to cadmium exhibit CDB levels less than 5 [micro]g/l.

            5.1.6.2 CDB concentrations among exposed workers

    Table 5 is a summary of results from studies reporting CDB levels 
among workers exposed to cadmium in the work place. As in Table 4, 
arithmetic and/or geometric means and standard deviations are provided 
if reported in the listed studies. The absolute range, or the 95% 
confidence interval around the mean, of the data in each study are 
provided when reported. In addition, the lower and upper 95th percentile 
of the distribution are presented for each study i which a mean and 
corresponding standard deviation were reported. Table 5 also provides 
estimates of the duration, and level, of exposure to cadmium in the work 
place if these data were reported in the listed studies. The data 
presented in table 5 suggest that CDB levels are dose related. Sukuri et 
al. (1983) show that higher CDB levels are observed among workers 
experiencing higher work place exposure. This trend appears to be true 
of the studies listed in the table.
    CDB levels reported in table 5 are higher among those showing signs 
of cadmium-related kidney damage than those showing no such damage. 
Lauwerys et al. (1976) report CDB levels among workers with kidney 
lesions that generally are above the levels reported for workers without 
kidney lesions. Ellis et al. (1983) report a similar observation 
comparing workers with and without renal dysfunction, although they 
found more overlap between the 2 groups than Lauwerys et al.

[[Page 206]]



                                                              Table 5--Blood Cadmium in Workers Exposed to Cadmium in the Workplace
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                Concentrations of Cadmium in blood \a\
                                                                                           Mean      -------------------------------------------------------------------------------------------
                                        Work environment      Number    Employment    concentration    Arithmetic mean   Absolute                Lower 95th   Upper 95th
           Study number                (worker population    in study    in years     of cadmium in   ( S.D.)   (95% C.I.)  mean (GSD)    of range     of range          Reference
                                                                                          m\3\)              \b\            \c\         \d\     \e\ ( ) \f\  \e\ ( ) \f\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................  Ni-Cd battery plant and  ........          3-40             <=90  ................  ..........  ..........  ...........  ...........  Lauwerys et al. 1976.
                                     Cd production plant:
                                     (Workers without              96  ............  ...............      21.4
                                                                                                                 1.9
                                     (Workers with kidney          25  ............  ...............      38.8
                                                                                                                 3.8
2.................................  Ni-Cd battery plant:     ........  ............  ...............  ................  ..........  ..........  ...........  ...........  Adamsson et al.
                                                                                                                                                                           (1979).
                                    (Smokers)..............         7           (5)             10.1            22.7      7.3-67.2
                                    (Nonsmokers)...........         8           (9)              7.0             7.0      4.9-10.5
3.................................  Cadmium alloy plant:     ........  ............  ...............  ................  ..........  ..........  ...........  ...........  Sukuri et al. 1982.
                                     (High exposure group).         7        (10.6)    [1,000-5 yrs;      20.8
                                                                                                                 7.1
                                     (Low exposure group)..         9         (7.3)        40-5 yrs]       7.1
                                                                                                                 1.1
4.................................  Retrospective study of         19         15-41  ...............  ................  ..........  ..........  ...........  ...........  Roels et al. 1982.
                                     workers with renal
                                     problems:
                                     (Before removal)......  ........        (27.2)  ...............      39.9
                                                                                                                 3.7
                                     (After removal).......  ........      \g\(4.2)  ...............      14.1
                                                                                                                 5.6
5.................................  Cadmium production       ........  ............  ...............  ................  ..........  ..........  ...........  ...........  Ellis et al. 1983.
                                     plant:
                                     (Workers without renal        33          1-34  ...............  155.7
                                     (Workers with renal           18         10-34  ...............  248.5
6.................................  Cd-Cu alloy plant......        75      Up to 39  ...............  ................  ..........   8.8
                                                                                                                 5.3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Concentrations reported in [micro]g Cd/l blood unless otherwise stated.
\b\ S.D.--Standard Deviation.
\c\ C.I.--Confidence Interval.
\d\ GSD--Geometric Standard Deviation.
\e\ Based on an assumed lognormal distribution.
\f\ Based on an assumed normal distribution.
\g\ Years following removal.


[[Page 207]]

    The data in table 5 also indicate that CDB levels are higher among 
those experiencing current occupational exposure than those who have 
been removed from such exposure. Roels et al. (1982) indicate that CDB 
levels observed among workers experiencing ongoing exposure in the work 
place are almost entirely above levels observed among workers removed 
from such exposure. This finding suggests that CDB levels decrease once 
cadmium exposure has ceased.
    A comparison of the data presented in tables 4 and 5 indicates that 
CDB levels observed among cadmium-exposed workers is significantly 
higher than levels observed among the unexposed groups. With the 
exception of 2 studies presented in table 5 (1 of which includes former 
workers in the sample group tested), the lower 95th percentile for CDB 
levels among exposed workers are greater than 5 [micro]g/l, which is the 
value of the upper 95th percentile for CDB levels observed among those 
who are not occupationally exposed. Therefore, a CDB level of 5 
[micro]g/l represents a threshold above which significant work place 
exposure to cadmium may be occurring.

              5.1.7 Conclusions and Recommendations for CDB

    Based on the above evaluation, the following recommendations are 
made for a CDB proficiency program.

                       5.1.7.1 Recommended method

    The method of Stoeppler and Brandt (1980) should be adopted for 
analyzing CDB. This method was selected over other methods for its 
straightforward sample-preparation procedures, and because limitations 
of the method were described adequately. It also is the method used by a 
plurality of laboratories currently participating in the CTQ proficiency 
program. In a recent CTQ interlaboratory comparison report (CTQ 1991), 
analysis of the methods used by laboratories to measure CDB indicates 
that 46% (11 of 24) of the participating laboratories used the Stoeppler 
and Brandt methodology (HNO3 deproteinization of blood 
followed by analysis of the supernatant by GF-AAS). Other CDB methods 
employed by participating laboratories identified in the CTQ report 
include dilution of blood (29%), acid digestion (12%) and miscellaneous 
methods (12%).
    Laboratories may adopt alternate methods, but it is the 
responsibility of the laboratory to demonstrate that the alternate 
methods meet the data quality objectives defined for the Stoeppler and 
Brandt method (see Section 5.1.7.2 below).

                     5.1.7.2 Data quality objectives

    Based on the above evaluation, the following data quality objectives 
(DQOs) should facilitate interpretation of analytical results.
    Limit of Detection. 0.5 [micro]g/l should be achievable using the 
Stoeppler and Brandt method. Stoeppler and Brandt (1980) report a limit 
of detection equivalent to <=0.2 [micro]g/l in whole blood using 25 
[micro]l aliquots of deproteinized, diluted blood samples.
    Accuracy. Initially, some of the laboratories performing CDB 
measurements may be expected to satisfy criteria similar to the less 
severe criteria specified by the CTQ program, i.e., measurements within 
2 [micro]g/l or 15% (whichever is greater) of the target value. About 
60% of the laboratories enrolled in the CTQ program could meet this 
criterion on the first proficiency test (Weber 1988).
    Currently, approximately 12 laboratories in the CTQ program are 
achieving an accuracy for CDB analysis within the more severe 
constraints of 1 [micro]g/l or 15% (whichever is 
greater). Later, as laboratories gain experience, they should achieve 
the level of accuracy exhibited by these 12 laboratories. The experience 
in the CTQ program has shown that, even without incentives, laboratories 
benefit from the feedback of the program; after they have analyzed 40-50 
control samples from the program, performance improves to the point 
where about 60% of the laboratories can meet the stricter criterion of 
1 [micro]g/l or 15% (Weber 1988). Thus, this 
stricter target accuracy is a reasonable DQO.
    Precision. Although Stoeppler and Brandt (1980) suggest that a 
coefficient of variation (CV) near 1.3% (for a 10 [micro]g/l 
concentration) is achievable for within-run reproducibility, it is 
recognized that other factors affecting within- and between-run 
comparability will increase the achievable CV. Stoeppler and Brandt 
(1980) observed CVs that were as high as 30% for low concentrations (0.4 
[micro]g/l), and CVs of less than 5% for higher concentrations.
    For internal QC samples (see Section 3.3.1), laboratories should 
attain an overall precision near 25%. For CDB samples with 
concentrations less than 2 [micro]g/l, a target precision of 40% is 
reasonable, while precisions of 20% should be achievable for 
concentrations greater than 2 [micro]g/l. Although these values are more 
strict than values observed in the CTQ interlaboratory program reported 
by Webber (1988), they are within the achievable limits reported by 
Stoeppler and Brandt (1980).

                5.1.7.3 Quality assurance/quality control

    Commercial laboratories providing measurement of CDB should adopt an 
internal QA/QC program that incorporates the following components: 
Strict adherence to the selected method, including all calibration 
requirements; regular incorporation of QC samples during actual runs; a 
protocol for corrective actions, and documentation of

[[Page 208]]

these actions; and, participation in an interlaboratory proficiency 
program. Note that the nonmandatory QA/QC program presented in 
Attachment 1 is based on the Stoeppler and Brandt method for CDB 
analysis. Should an alternate method be adopted, the laboratory should 
develop a QA/QC program satisfying the provisions of Section 3.3.1.

                  5.2 Measuring Cadmium in Urine (CDU)

    As in the case of CDB measurement, proper determination of CDU 
requires strict analytical discipline regarding collection and handling 
of samples. Because cadmium is both ubiquitous in the environment and 
employed widely in coloring agents for industrial products that may be 
used during sample collection, preparation and analysis, care should be 
exercised to ensure that samples are not contaminated during the 
sampling procedure.
    Methods for CDU determination share many of the same features as 
those employed for the determination of CDB. Thus, changes and 
improvements to methods for measuring CDU over the past 40 years 
parallel those used to monitor CDB. The direction of development has 
largely been toward the simplification of sample preparation techniques 
made possible because of improvements in analytic techniques.

                     5.2.1 Units of CDU Measurement

    Procedures adopted for reporting CDU concentrations are not uniform. 
In fact, the situation for reporting CDU is more complicated than for 
CDB, where concentrations are normalized against a unit volume of whole 
blood.
    Concentrations of solutes in urine vary with several biological 
factors (including the time since last voiding and the volume of liquid 
consumed over the last few hours); as a result, solute concentrations 
should be normalized against another characteristic of urine that 
represents changes in solute concentrations. The 2 most common 
techniques are either to standardize solute concentrations against the 
concentration of creatinine, or to standardize solute concentrations 
against the specific gravity of the urine. Thus, CDU concentrations have 
been reported in the literature as ``uncorrected'' concentrations of 
cadmium per volume of urine (i.e., [micro]g Cd/l urine), ``corrected'' 
concentrations of cadmium per volume of urine at a standard specific 
gravity (i.e., [micro]g Cd/l urine at a specific gravity of 1.020), or 
``corrected'' mass concentration per unit mass of creatinine (i.e., 
[micro]g Cd/g creatinine). (CDU concentrations [whether uncorrected or 
corrected for specific gravity, or normalized to creatinine] 
occasionally are reported in nanomoles [i.e., nmoles] of cadmium per 
unit mass or volume. In this protocol, these values are converted to 
[micro]g of cadmium per unit mass or volume using 89 nmoles of 
cadmium=10 [micro]g.)
    While it is agreed generally that urine values of analytes should be 
normalized for reporting purposes, some debate exists over what 
correction method should be used. The medical community has long favored 
normalization based on creatinine concentration, a common urinary 
constituent. Creatinine is a normal product of tissue catabolism, is 
excreted at a uniform rate, and the total amount excreted per day is 
constant on a day-to-day basis (NIOSH 1984b). While this correction 
method is accepted widely in Europe, and within some occupational health 
circles, Kowals (1983) argues that the use of specific gravity (i.e., 
total solids per unit volume) is more straightforward and practical 
(than creatinine) in adjusting CDU values for populations that vary by 
age or gender.
    Kowals (1983) found that urinary creatinine (CRTU) is lower in 
females than males, and also varies with age. Creatinine excretion is 
highest in younger males (20-30 years old), decreases at middle age (50-
60 years), and may rise slightly in later years. Thus, cadmium 
concentrations may be underestimated for some workers with high CRTU 
levels.
    Within a single void urine collection, urine concentration of any 
analyte will be affected by recent consumption of large volumes of 
liquids, and by heavy physical labor in hot environments. The absolute 
amount of analyte excreted may be identical, but concentrations will 
vary widely so that urine must be corrected for specific gravity (i.e., 
to normalize concentrations to the quantity of total solute) using a 
fixed value (e.g., 1.020 or 1.024). However, since heavy-metal exposure 
may increase urinary protein excretion, there is a tendency to 
underestimate cadmium concentrations in samples with high specific 
gravities when specific-gravity corrections are applied.
    Despite some shortcomings, reporting solute concentrations as a 
function of creatinine concentration is accepted generally; OSHA 
therefore recommends that CDU levels be reported as the mass of cadmium 
per unit mass of creatinine ([micro]g/g CTRU).
    Reporting CDU as [micro]g/g CRTU requires an additional analytical 
process beyond the analysis of cadmium: Samples must be analyzed 
independently for creatinine so that results may be reported as the 
ratio of cadmium to creatinine concentrations found in the urine sample. 
Consequently, the overall quality of the analysis depends on the 
combined performance by a laboratory on these 2 determinations. The 
analysis used for CDU determinations is addressed below in terms of 
[micro]g Cd/l, with analysis of creatinine addressed separately. 
Techniques for assessing creatinine are discussed in Section 5.4.

[[Page 209]]

    Techniques for deriving cadmium as a ratio of CRTU, and the 
confidence limits for independent measurements of cadmium and CRTU, are 
provided in Section 3.3.3.

             5.2.2 Analytical Techniques Used To Monitor CDU

    Analytical techniques used for CDU determinations are similar to 
those employed for CDB determinations; these techniques are summarized 
in Table 3. As with CDB monitoring, the technique most suitable for CDU 
determinations is atomic absorption spectroscopy (AAS). AAS methods used 
for CDU determinations typically employ a graphite furnace, with 
background correction made using either the deuterium-lamp or Zeeman 
techniques; Section 5.1.1 provides a detailed description of AAS 
methods.

             5.2.3 Methods Developed for CDU Determinations

    Princi (1947), Smith et al. (1955), Smith and Kench (1957), and 
Tsuchiya (1967) used colorimetric procedures similar to those described 
in the CDB section above to estimate CDU concentrations. In these 
methods, urine (50 ml) is reduced to dryness by heating in a sand bath 
and digested (wet ashed) with mineral acids. Cadmium then is complexed 
with dithiazone, extracted with chloroform and quantified by 
spectrophotometry. These early studies typically report reagent blank 
values equivalent to 0.3 [micro]g Cd/l, and CDU concentrations among 
nonexposed control groups at maximum levels of 10 [micro]g Cd/l--
erroneously high values when compared to more recent surveys of cadmium 
concentrations in the general population.
    By the mid-1970s, most analytical procedures for CDU analysis used 
either wet ashing (mineral acid) or high temperatures (400 
[deg]C) to digest the organic matrix of urine, followed by cadmium 
chelation with APDC or DDTC solutions and extraction with MIBK. The 
resulting aliquots were analyzed by flame or graphite-furnace AAS 
(Kjellstrom 1979).
    Improvements in control over temperature parameters with 
electrothermal heating devices used in conjunction with flameless AAS 
techniques, and optimization of temperature programs for controlling the 
drying, charring, and atomization processes in sample analyses, led to 
improved analytical detection of diluted urine samples without the need 
for sample digestion or ashing. Roels et al. (1978) successfully used a 
simple sample preparation, dilution of 1.0 ml aliquots of urine with 0.1 
N HNO3, to achieve accurate low-level determinations of CDU.
    In the method described by Pruszkowska et al. (1983), which has 
become the preferred method for CDU analysis, urine samples were diluted 
at a ratio of 1:5 with water; diammonium hydrogenphosphate in dilute 
HNO3 was used as a matrix modifier. The matrix modifier 
allows for a higher charring temperature without loss of cadmium through 
volatilization during preatomization. This procedure also employs a 
stabilized temperature platform in a graphite furnace, while nonspecific 
background absorbtion is corrected using the Zeeman technique. This 
method allows for an absolute detection limit of approximately 0.04 
[micro]g Cd/l urine.

                  5.2.4 Sample Collection and Handling

    Sample collection procedures for CDU may contribute to variability 
observed among CDU measurements. Sources of variation attendant to 
sampling include time-of-day, the interval since ingestion of liquids, 
and the introduction of external contamination during the collection 
process. Therefore, to minimize contributions from these variables, 
strict adherence to a sample-collection protocol is recommended. This 
protocol should include provisions for normalizing the conditions under 
which urine is collected. Every effort also should be made to collect 
samples during the same time of day.
    Collection of urine samples from an industrial work force for 
biological monitoring purposes usually is performed using ``spot'' 
(i.e., single-void) urine with the pH of the sample determined 
immediately. Logistic and sample-integrity problems arise when efforts 
are made to collect urine over long periods (e.g., 24 hrs). Unless 
single-void urines are used, there are numerous opportunities for 
measurement error because of poor control over sample collection, 
storage and environmental contamination.
    To minimize the interval during which sample urine resides in the 
bladder, the following adaption to the ``spot'' collection procedure is 
recommended: The bladder should first be emptied, and then a large glass 
of water should be consumed; the sample may be collected within an hour 
after the water is consumed.

                    5.2.5 Best Achievable Performance

    Performance using a particular method for CDU determinations is 
assumed to be equivalent to the performance reported by the research 
laboratories in which the method was developed. Pruszkowska et al. 
(1983) report a detection limit of 0.04 [micro]g/l CDU, with a CV of <4% 
between 0-5 [micro]g/l. The CDC reports a minimum CDU detection limit of 
0.07 [micro]g/l using a modified method based on Pruszkowska et al. 
(1983). No CV is stated in this protocol; the protocol contains only 
rejection criteria for internal QC parameters used during accuracy 
determinations with known standards (Attachment 8 of exhibit 106 of OSHA 
docket H057A). Stoeppler and Brandt (1980) report a CDU detection limit 
of 0.2 [micro]/l for their methodology.

[[Page 210]]

                    5.2.6 General Method Performance

    For any particular method, the expected initial performance from 
commercial laboratories may be somewhat lower than that reported by the 
research laboratory in which the method was developed. With 
participation in appropriate proficiency programs, and use of a proper 
in-house QA/QC program incorporating provisions for regular corrective 
actions, the performance of commercial laboratories may be expected to 
improve and approach that reported by a research laboratories. The 
results reported for existing proficiency programs serve to specify the 
initial level of performance that likely can be expected from commercial 
laboratories offering analysis using a particular method.
    Weber (1988) reports on the results of the CTQ proficiency program, 
which includes CDU results for laboratories participating in the 
program. Results indicate that after receiving 60 samples (i.e., after 
participating in the program for approximately 3 years), approximately 
80% of the participating laboratories report CDU results ranging between 
2 [micro]g/l or 15% of the consensus mean, 
whichever is greater. On any single sample of the last 15 samples, the 
proportion of laboratories falling within the specified range is between 
75 and 95%, except for a single test for which only 60% of the 
laboratories reported acceptable results. For each of the last 15 
samples, approximately 60% of the laboratories reported results within 
1 [micro]g or 15% of the mean, whichever is 
greater. The range of concentrations included in this set of samples was 
not reported.
    Another report from the CTQ (1991) summarizes preliminary CDU 
results from their 1991 interlaboratory program. According to the 
report, for 3 CDU samples with values of 9.0, 16.8, 31.5 [micro]g/l, 
acceptable results (target of 2 [micro]g/l or 15 % 
of the consensus mean, whichever is greater) were achieved by only 44-
52% of the 34 laboratories participating in the CDU program. The overall 
CVs for these 3 CDU samples among the 34 participating laboratories were 
31%, 25%, and 49%, respectively. The reason for this poor performance 
has not been determined.
    A more recent report from the CTQ (Weber, private communication) 
indicates that 36% of the laboratories in the program have been able to 
achieve the target of 1 [micro]g/l or 15% for more 
than 75% of the samples analyzed over the last 5 years, while 45% of 
participating laboratories achieved a target of 2 
[micro]g/l or 15% for more than 75% of the samples analyzed over the 
same period.
    Note that results reported in the interlaboratory programs are in 
terms of [micro]g Cd/l of urine, unadjusted for creatinine. The 
performance indicated, therefore, is a measure of the performance of the 
cadmium portion of the analyses, and does not include variation that may 
be introduced during the analysis of CRTU.

                    5.2.7 Observed CDU Concentrations

    Prior to the onset of renal dysfunction, CDU concentrations provide 
a general indication of the exposure history (i.e., body burden) (see 
Section 4.3). Once renal dysfunction occurs, CDU levels appear to 
increase and are no longer indicative solely of cadmium body burden 
(Friberg and Elinder 1988).

  5.2.7.1 Range of CDU concentrations observed among unexposed samples

    Surveys of CDU concentrations in the general population were first 
reported from cooperative studies among industrial countries (i.e., 
Japan, U.S. and Sweden) conducted in the mid-1970s. In summarizing these 
data, Kjellstrom (1979) reported that CDU concentrations among Dallas, 
Texas men (age range: <9-59 years; smokers and nonsmokers) varied from 
0.11-1.12 [micro]g/l (uncorrected for creatinine or specific gravity). 
These CDU concentrations are intermediate between population values 
found in Sweden (range: 0.11-0.80 [micro]g/l) and Japan (range: 0.14-
2.32 [micro]g/l).
    Kowal and Zirkes (1983) reported CDU concentrations for almost 1,000 
samples collected during 1978-79 from the general U.S. adult population 
(i.e., nine states; both genders; ages 20-74 years). They report that 
CDU concentrations are lognormally distributed; low levels predominated, 
but a small proportion of the population exhibited high levels. These 
investigators transformed the CDU concentrations values, and reported 
the same data 3 different ways: [micro]g/l urine (unadjusted), [micro]g/
l (specific gravity adjusted to 1.020), and [micro]g/g CRTU. These data 
are summarized in Tables 6 and 7.
    Based on further statistical examination of these data, including 
the lifestyle characteristics of this group, Kowal (1988) suggested 
increased cadmium absorption (i.e., body burden) was correlated with low 
dietary intakes of calcium and iron, as well as cigarette smoking.
    CDU levels presented in Table 6 are adjusted for age and gender. 
Results suggest that CDU levels may be slightly different among men and 
women (i.e., higher among men when values are unadjusted, but lower 
among men when the values are adjusted, for specific gravity or CRTU). 
Mean differences among men and women are small compared to the standard 
deviations, and therefore may not be significant. Levels of CDU also 
appear to increase with age. The data in Table 6 suggest as well that 
reporting CDU levels adjusted for specific gravity or as a function of 
CRTU results in reduced variability.

[[Page 211]]



 Table 6--Urine Cadmium Concentrations in the U.S. Adult Population: Normal and Concentration-Adjusted Values by
                                                 Age and Sex \1\
----------------------------------------------------------------------------------------------------------------
                                                                      Geometric means (and geometric standard
                                                                                    deviations)
                                                                 -----------------------------------------------
                                                                                    SG-adjusted      Creatine-
                                                                    Unadjusted    \2\ [micro]g/l     adjusted
                                                                   ([micro]g/l)      at 1.020)     ([micro]g/g)
----------------------------------------------------------------------------------------------------------------
Sex:
    Male (n=484)................................................      0.55 (2.9)      0.73 (2.6)      0.55 (2.7)
    Female (n=498)..............................................      0.49 (3.0)      0.86 (2.7)      0.78 (2.7)
Age:
    20-29 (n=222)...............................................      0.32 (3.0)      0.43 (2.7)      0.32 (2.7)
    30-39 (n=141)...............................................      0.46 (3.2)      0.70 (2.8)      0.54 (2.7)
    40-49 (n=142)...............................................      0.50 (3.0)      0.81 (2.6)      0.70 (2.7)
    50-59 (n=117)...............................................      0.61 (2.9)      0.99 (2.4)      0.90 (2.3)
    60-69 (n=272)...............................................      0.76 (2.6)      1.16 (2.3)      1.03 (2.3)
----------------------------------------------------------------------------------------------------------------
\1\ From Kowal and Zirkes 1983.
\2\ SC-adjusted is adjusted for specific gravity.


Table 7--Urine Cadmium Concentrations in the U.S. Adult Population: Cumulative Frequency Distribution of Urinary
                                               Cadmium (N=982) \1\
----------------------------------------------------------------------------------------------------------------
                                                                                                     Creatine-
                                                                    Unadjusted      SG-adjusted      adjusted
                     Range of concentrations                       ([micro]g/l)   ([micro]g/l at   ([micro]g/g)
                                                                      percent     1.020) percent      percent
----------------------------------------------------------------------------------------------------------------
<0.5............................................................            43.9            28.0            35.8
 0.6-1.0........................................................            71.7            56.4            65.6
 1.1-1.5........................................................            84.4            74.9            81.4
 1.6-2.0........................................................            91.3            84.7            88.9
 2.1-3.0........................................................            97.3            94.4            95.8
 3.1-4.0........................................................            98.8            97.4            97.2
 4.1-5.0........................................................            99.4            98.2            97.9
 5.1-10.0.......................................................            99.6            99.4            99.3
 10.0-20.0......................................................            99.8            99.6            99.6
----------------------------------------------------------------------------------------------------------------
\1\ Source: Kowal and Zirkes (1983).

    The data in the Table 6 indicate the geometric mean of CDU levels 
observed among the general population is 0.52 [micro]/g Cd/l urine 
(unadjusted), with a geometric standard deviation of 3.0. Normalized for 
creatinine, the geometric mean for the population is 0.66 [micro]/g 
CRTU, with a geometric standard deviation of 2.7. Table 7 provides the 
distributions of CDU concentrations for the general population studied 
by Kowal and Zirkes. The data in this table indicate that 95% of the CDU 
levels observed among those not occupationally exposed to cadmium are 
below 3 [micro]/g CRTU.

   5.2.7.2 Range of CDU concentrations observed among exposed workers

    Table 8 is a summary of results from available studies of CDU 
concentrations observed among cadmium-exposed workers. In this table, 
arithmetic and/or geometric means and standard deviations are provided 
if reported in these studies. The absolute range for the data in each 
study, or the 95% confidence interval around the mean of each study, 
also are provided when reported. The lower and upper 95th percentile of 
the distribution are presented for each study in which a mean and 
corresponding standard deviation were reported. Table 8 also provides 
estimates of the years of exposure, and the levels of exposure, to 
cadmium in the work place if reported in these studies. Concentrations 
reported in this table are in [micro]/g CRTU, unless otherwise stated.

[[Page 212]]



                                                      Table 8--Urine Cadmium Concentrations in Workers Exposed to Cadmium in the Workplace
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                          Concentration of cadmium in Urine \a\
                                                                              Mean      --------------------------------------------------------------------------------------------------------
                      Work environment (worker   Number    Employment    Concentration    Arithmetic mean   Absolute                Lower 95th   Upper 95th
    Study number       population monitored)    in Study    in years     of cadmium in   ( S.D.)   (95% C.I.)  mean (GSD)    of range     of range                Reference
                                                                             m\3\)              \b\            \c\         \d\     \e\ ( ) \f\  \e\ ( ) \f\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1..................  Ni-Cd battery plant and    ........          3-40            <= 90  ................  ..........  ..........  ...........  ...........  Lauwerys et al. 1976.
                      Cd production plant.
                      (Workers without kidney         96  ............  ...............      16.3
                                                                                                   16.7
                      (Workers with kidney            25  ............  ...............      48.2
                                                                                                   42.6
2..................  Ni-Cd battery plant......  ........  ............  ...............  ................  ..........  ..........  ...........  ...........  Adamsson et al. (1979).
                      (Smokers)...............         7           (5)             10.1             5.5      1.0-14.7
                      (Nonsmokers)............         8           (9)              7.0             3.6       0.5-9.3
3..................  Cadmium salts production        148        (15.4)  ...............            15.8         2-150  ..........  ...........  ...........  Butchet et al. 1980.
                      facility.
4..................  Retrospective study of           19         15-41  ...............  ................  ..........  ..........  ...........  ...........  Roels et al. 1982.
                      workers with renal
                      problems.
                      (Before removal)........  ........        (27.2)  ...............      39.4
                                                                                                   28.1
                      (After removal).........  ........     (4.2) \g\  ...............      16.4
                                                                                                    9.0
5..................  Cadmium production plant.  ........  ............  ...............  ................  ..........  ..........  ...........  ...........  Ellis et al. 1983.
                      (Workers without renal          33          1-34  ...............       9.4
                                                                                                    6.9
                      (Workers with renal             18         10-34  ...............      22.8
                                                                                                   12.7
6..................  Cd-Cu alloy plant........        75      Up to 39           Note h       6.9
                                                                                                    9.4
7..................  Cadmium recovery                 45          (19)               87       9.3
                                                                                                    6.9
8..................  Pigment manufacturing            29        (12.8)         0.18-3.0  ................     0.2-9.5         1.1  ...........  ...........  Mueller et al. 1989.
                      plant.
9..................  Pigment manufacturing            26        (12.1)            <=3.0  ................  ..........  1.251 [micro]g/l or 15% for more 
than 75% of the samples analyzed over the last 5 years, while 45% of 
participating laboratories achieve a target of 2 
[micro]g/l or 15% for more than 75% of the samples analyzed over the 
same period. With time and a strong incentive for improvement, it is 
expected that the proportion of laboratories successfully achieving the 
stricter level of accuracy should increase. It should be noted, however, 
these indices of performance do not include variations resulting from 
the ancillary measurement of CRTU (which is recommended for the proper 
recording of results). The low cadmium levels expected to be measured 
indicate that the analysis of creatinine will contribute relatively 
little to the overall variability observed among creatinine-normalized 
CDU levels (see Section 5.4). The initial target value for reporting CDU 
under this program, therefore, is set at 1 
[micro]g/g CRTU or 15% (whichever is greater).
    Precision. For internal QC samples (which are recommended as part of 
an internal QA/QC program, Section 3.3.1), laboratories should attain an 
overall precision of 25%. For CDB samples with concentrations less than 
2 [micro]g/l, a target precision of 40% is acceptable, while precisions 
of 20% should be achievable for CDU concentrations greater than 2 
[micro]g/l. Although these values are more stringent than those observed 
in the CTQ interlaboratory program reported by Webber (1988), they are 
well within limits expected to be achievable for the method as reported 
by Stoeppler and Brandt (1980).

                5.2.8.3 Quality assurance/quality control

    Commercial laboratories providing CDU determinations should adopt an 
internal QA/QC program that incorporates the following components: 
Strict adherence to the selected method, including calibration 
requirements; regular incorporation of QC samples during actual runs; a 
protocol for corrective actions, and documentation of such actions; and, 
participation in an interlaboratory proficiency program. Note that the 
nonmandatory program presented in Attachment 1 as an example of an 
acceptable QA/QC program, is based on using the Pruszkowska method for 
CDU analysis. Should an alternate method be adopted by a laboratory, the 
laboratory should develop a QA/QC program equivalent to the nonmandatory 
program, and which satisfies the provisions of Section 3.3.1.

          5.3 Monitoring [beta]-2-Microglobulin in Urine (B2MU)

    As indicated in Section 4.3, B2MU appears to be the best of several 
small proteins that may be monitored as early indicators of cadmium-
induced renal damage. Several analytic techniques are available for 
measuring B2M.

                     5.3.1 Units of B2MU Measurement

    Procedures adopted for reporting B2MU levels are not uniform. In 
these guidelines, OSHA recommends that B2MU levels be reported as 
[micro]g/g CRTU, similar to reporting CDU concentrations. Reporting B2MU 
normalized to the concentration of CRTU requires an additional 
analytical process beyond the analysis of B2M: Independent analysis for 
creatinine so that results may be reported as a ratio of the B2M and 
creatinine concentrations found in the urine sample. Consequently, the 
overall quality of the analysis depends on the combined performance on 
these 2 analyses. The analysis used for B2MU determinations is described 
in terms of [micro]g B2M/l urine, with analysis of creatinine addressed 
separately. Techniques used to measure creatinine are provided in 
Section 5.4. Note that Section 3.3.3 provides techniques for deriving 
the value of B2M as function of CRTU, and the confidence limits for 
independent measurements of B2M and CRTU.

            5.3.2 Analytical Techniques Used To Monitor B2MU

    One of the earliest tests used to measure B2MU was the radial 
immunodiffusion technique. This technique is a simple and specific 
method for identification and quantitation of a number of proteins found 
in human serum and other body fluids when the protein is not readily 
differentiated by standard electrophoretic procedures. A quantitative 
relationship exists between the concentration of a protein deposited in 
a well that is cut into a thin agarose layer containing the 
corresponding monospecific antiserum, and the distance that the 
resultant complex diffuses. The wells are filled with an unknown serum 
and the standard (or control), and incubated in a moist environment at 
room temperature. After the optimal point of diffusion has been reached, 
the diameters of the resulting precipition rings are measured. The 
diameter of a ring is related to the concentration of the constituent 
substance. For B2MU determinations required in the medical monitoring 
program, this method requires a process that may be insufficient to 
concentrate the protein to levels that are required for detection.
    Radioimmunoassay (RIA) techniques are used widely in immunologic 
assays to measure the concentration of antigen or antibody in body-fluid 
samples. RIA procedures are based on competitive-binding techniques. If 
antigen concentration is being measured, the principle underlying the 
procedure is that radioactive-labeled antigen competes with the sample's 
unlabeled antigen for binding sites on a known amount of immobile 
antibody. When these 3 components are present in the system, an 
equilibrium exists. This equilibrium is followed by a separation of

[[Page 215]]

the free and bound forms of the antigen. Either free or bound 
radioactive-labeled antigen can be assessed to determine the amount of 
antigen in the sample. The analysis is performed by measuring the level 
of radiation emitted either by the bound complex following removal of 
the solution containing the free antigen, or by the isolated solution 
containing the residual-free antigen. The main advantage of the RIA 
method is the extreme sensitivity of detection for emitted radiation and 
the corresponding ability to detect trace amounts of antigen. 
Additionally, large numbers of tests can be performed rapidly.
    The enzyme-linked immunosorbent assay (ELISA) techniques are similar 
to RIA techniques except that nonradioactive labels are employed. This 
technique is safe, specific and rapid, and is nearly as sensitive as RIA 
techniques. An enzyme-labeled antigen is used in the immunologic assay; 
the labeled antigen detects the presence and quantity of unlabeled 
antigen in the sample. In a representative ELISA test, a plastic plate 
is coated with antibody (e.g., antibody to B2M). The antibody reacts 
with antigen (B2M) in the urine and forms an antigen-antibody complex on 
the plate. A second anti-B2M antibody (i.e., labeled with an enzyme) is 
added to the mixture and forms an antibody-antigen-antibody complex. 
Enzyme activity is measured spectrophotometrically after the addition of 
a specific chromogenic substrate which is activated by the bound enzyme. 
The results of a typical test are calculated by comparing the 
spectrophotometric reading of a serum sample to that of a control or 
reference serum. In general, these procedures are faster and require 
less laboratory work than other methods.
    In a fluorescent ELISA technique (such as the one employed in the 
Pharmacia Delphia test for B2M), the labeled enzyme is bound to a strong 
fluorescent dye. In the Pharmacia Delphia test, an antigen bound to a 
fluorescent dye competes with unlabeled antigen in the sample for a 
predetermined amount of specific, immobile antibody. Once equilibrium is 
reached, the immobile phase is removed from the labeled antigen in the 
sample solution and washed; an enhancement solution then is added that 
liberates the fluorescent dye from the bound antigen-antibody complex. 
The enhancement solution also contains a chelate that complexes with the 
fluorescent dye in solution; this complex increases the fluorescent 
properties of the dye so that it is easier to detect.
    To determine the quantity of B2M in a sample using the Pharmacia 
Delphia test, the intensity of the fluorescence of the enhancement 
solution is measured. This intensity is proportional to the 
concentration of labeled antigen that bound to the immobile antibody 
phase during the initial competition with unlabeled antigen from the 
sample. Consequently, the intensity of the fluorescence is an inverse 
function of the concentration of antigen (B2M) in the original sample. 
The relationship between the fluorescence level and the B2M 
concentration in the sample is determined using a series of graded 
standards, and extrapolating these standards to find the concentration 
of the unknown sample.

             5.3.3 Methods Developed for B2MU Determinations

    B2MU usually is measured by radioimmunoassay (RIA) or enzyme-linked 
immunosorbent assay (ELISA); however, other methods (including gel 
electrophoresis, radial immunodiffusion, and nephelometric assays) also 
have been described (Schardun and van Epps 1987). RIA and ELISA methods 
are preferred because they are sensitive at concentrations as low as 
micrograms per liter, require no concentration processes, are highly 
reliable and use only a small sample volume.
    Based on a survey of the literature, the ELISA technique is 
recommended for monitoring B2MU. While RIAs provide greater sensitivity 
(typically about 1 [micro]g/l, Evrin et al. 1971), they depend on the 
use of radioisotopes; use of radioisotopes requires adherence to rules 
and regulations established by the Atomic Energy Commission, and 
necessitates an expensive radioactivity counter for testing. 
Radioisotopes also have a relatively short half-life, which corresponds 
to a reduced shelf life, thereby increasing the cost and complexity of 
testing. In contrast, ELISA testing can be performed on routine 
laboratory spectrophotometers, do not necessitate adherence to 
additional rules and regulations governing the handling of radioactive 
substances, and the test kits have long shelf lives. Further, the range 
of sensitivity commonly achieved by the recommended ELISA test (i.e., 
the Pharmacia Delphia test) is approximately 100 [micro]g/l (Pharmacia 
1990), which is sufficient for monitoring B2MU levels resulting from 
cadmium exposure. Based on the studies listed in Table 9 (Section 
5.3.7), the average range of B2M concentrations among the general, 
nonexposed population falls between 60 and 300 [micro]g/g CRTU. The 
upper 95th percentile of distributions, derived from studies in Table 9 
which reported standard deviations, range between 180 and 1,140 
[micro]g/g CRTU. Also, the Pharmacia Delphia test currently is the most 
widely used test for assessing B2MU.

[[Page 216]]

                  5.3.4 Sample Collection and Handling

    As with CDB or CDU, sample collection procedures are addressed 
primarily to identify ways to minimize the degree of variability 
introduced by sample collection during medical monitoring. It is unclear 
the extent to which sample collection contributes to B2MU variability. 
Sources of variation include time-of-day effects, the interval since 
consuming liquids and the quantity of liquids consumed, and the 
introduction of external contamination during the collection process. A 
special problem unique to B2M sampling is the sensitivity of this 
protein to degradation under acid conditions commonly found in the 
bladder. To minimize this problem, strict adherence to a sampling 
protocol is recommended. The protocol should include provisions for 
normalizing the conditions under which the urine is collected. Clearly, 
it is important to minimize the interval urine spends in the bladder. It 
also is recommended that every effort be made to collect samples during 
the same time of day.
    Collection of urine samples for biological monitoring usually is 
performed using ``spot'' (i.e., single-void) urine. Logistics and sample 
integrity become problems when efforts are made to collect urine over 
extended periods (e.g., 24 hrs). Unless single-void urines are used, 
numerous opportunities exist for measurement error because of poor 
control over sample collection, storage and environmental contamination.
    To minimize the interval that sample urine resides in the bladder, 
the following adaption to the ``spot'' collection procedure is 
recommended: The bladder should be emptied and then a large glass of 
water should be consumed; the sample then should be collected within an 
hour after the water is consumed.

                    5.3.5 Best Achievable Performance

    The best achievable performance is assumed to be equivalent to the 
performance reported by the manufacturers of the Pharmacia Delphia test 
kits (Pharmacia 1990). According to the insert that comes with these 
kits, QC results should be within 2 SDs of the 
mean for each control sample tested; a CV of less than or equal to 5.2% 
should be maintained. The total CV reported for test kits is less than 
or equal to 7.2%.

                    5.3.6 General Method Performance

    Unlike analyses for CDB and CDU, the Pharmacia Delphia test is 
standardized in a commercial kit that controls for many sources of 
variation. In the absence of data to the contrary, it is assumed that 
the achievable performance reported by the manufacturer of this test kit 
will serve as an achievable performance objective. The CTQ proficiency 
testing program for B2MU analysis is expected to use the performance 
parameters defined by the test kit manufacturer as the basis of the B2MU 
proficiency testing program.
    Note that results reported for the test kit are expressed in terms 
of [micro]g B2M/l of urine, and have not been adjusted for creatinine. 
The indicated performance, therefore, is a measure of the performance of 
the B2M portion of the analyses only, and does not include variation 
that may have been introduced during the analysis of creatinine.

                   5.3.7 Observed B2MU Concentrations

    As indicated in Section 4.3, the concentration of B2MU may serve as 
an early indicator of the onset of kidney damage associated with cadmium 
exposure.

      5.3.7.1 Range of B2MU concentrations among unexposed samples

    Most of the studies listed in Table 9 report B2MU levels for those 
who were not occupationally exposed to cadmium. Studies noted in the 
second column of this table (which contain the footnote ``d'') reported 
B2MU concentrations among cadmium-exposed workers who, nonetheless, 
showed no signs of proteinuria. These latter studies are included in 
this table because, as indicated in Section 4.3, monitoring B2MU is 
intended to provide advanced warning of the onset of kidney dysfunction 
associated with cadmium exposure, rather than to distinguish relative 
exposure. This table, therefore, indicates the range of B2MU levels 
observed among those who had no symptoms of renal dysfunction (including 
cadmium-exposed workers with none of these symptoms).

                                          Table 9--B-2-Microglobulin Concentrations Observed in Urine Among Those not Occupationally Exposed to Cadmium
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                           Lower 95th            Upper 95th
             Study No.                  No. in study         Geometric mean      Geometric standard       percentile of         percentile of                        Reference
                                                                                      deviation         distribution \a\      distribution \a\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................  133 m \b\...........  115 [micro]g/g \c\..  4.03................  12..................  1,140 [micro]g/g \c\  Ishizaki et al. 1989.
2.................................  161 f \b\...........  146 [micro]g/g \c\..  3.11................  23..................  940 [micro]g/g \c\..  Ishizaki et al. 1989.

[[Page 217]]

 
3.................................  10..................  84 [micro]g/g.......  ....................  ....................  ....................  Ellis et al. 1983.
4.................................  203.................  76 [micro]g/l.......  ....................  ....................  ....................  Stewart and Hughes 1981.
5.................................  9...................  103 [micro]g/g......  ....................  ....................  ....................  Chia et al. 1989.
6.................................  47 \d\..............  86 [micro]g/L.......  1.9.................  30 [micro]g/1.......  250 [micro]g/L......  Kjellstrom et al. 1977.
7.................................  1,000 \e\...........  68.1 [micro]g/gr Cr   3.1 m & f...........  < 10 [micro]g/gr Cr   320 [micro]g/gr Cr    Kowal 1983.
                                                           \f\.                                        \h\.                  \h\.
8.................................  87..................  71 [micro]g/g \i\...  ....................  7 \h\...............  200 \h\.............  Buchet et al. 1980.
9.................................  10..................  0.073 mg/24h........  ....................  ....................  ....................  Evrin et al. 1971.
10................................  59..................  156 [micro]g/g......  1.1 \j\.............  130.................  180.................  Mason et al. 1988.
11................................  8...................  118 [micro]g/g......  ....................  ....................  ....................  Iwao et al. 1980.
12................................  34..................  79 [micro]g/g.......  ....................  ....................  ....................  Wibowo et al. 1982.
13................................  41 m................  ....................  ....................  ....................  400 [micro]g/gr Cr    Falck et al. 1983.
                                                                                                                             \k\.
14................................  35 \n\..............  67..................  ....................  ....................  ....................  Roels et al. 1991.
15................................  31 \d\..............  63..................  ....................  ....................  ....................  Roels et al. 1991.
16................................  36 \d\..............  77 \i\..............  ....................  ....................  ....................  Miksche et al. 1981.
17................................  18 \n\..............  130.................  ....................  ....................  ....................  Kawada et al. 1989.
18................................  32 \p\..............  122.................  ....................  ....................  ....................  Kawada et al. 1989.
19................................  18 \d\..............  295.................  1.4.................  170.................  510.................  Thun et al. 1989.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
a--Based on an assumed lognormal distribution.
b--m = males, f = females.
c--Aged general population from non-polluted area; 47.9% population aged 50-69; 52.1% = 70 years of age; values reported in study.
d--Exposed workers without proteinuria.
e--492 females, 484 male.
f--Creatinine adjusted; males = 68.1 [micro]g/g Cr, females = 64.3 [micro]g/g Cr.
h--Reported in the study.
i--Arithmetic mean.
j--Geometric standard error.
k--Upper 95% tolerance limits: for Falck this is based on the 24 hour urine sample.
n--Controls.
p--Exposed synthetic resin and pigment workers without proteinuria; Cadmium in urine levels up to 10 [micro]g/g Cr.

    To the extent possible, the studies listed in Table 9 provide 
geometric means and geometric standard deviations for measurements among 
the groups defined in each study. For studies reporting a geometric 
standard deviation along with a mean, the lower and upper 95th 
percentile for these distributions were derived and reported in the 
table.
    The data provided from 15 of the 19 studies listed in Table 9 
indicate that the geometric mean concentration of B2M observed among 
those who were not occupationally exposed to cadmium is 70-170 [micro]g/
g CRTU. Data from the 4 remaining studies indicate that exposed workers 
who exhibit no signs of proteinuria show mean B2MU levels of 60-300 
[micro]g/g CRTU. B2MU values in the study by Thun et al. (1989), 
however, appear high in comparison to the other 3 studies. If this study 
is removed, B2MU levels for those who are not occupationally exposed to 
cadmium are similar to B2MU levels found among cadmium-exposed workers 
who exhibit no signs of kidney dysfunction. Although the mean is high in 
the study by Thun et al., the range of measurements reported in this 
study is within the ranges reported for the other studies.
    Determining a reasonable upper limit from the range of B2M 
concentrations observed among those who do not exhibit signs of 
proteinuria is problematic. Elevated B2MU levels are among the signs 
used to define the onset of kidney dysfunction. Without access to the 
raw data from the studies listed in Table 9, it is necessary to rely on 
reported standard deviations to estimate an upper limit for normal B2MU 
concentrations (i.e., the upper 95th percentile for the distributions 
measured). For the 8 studies reporting a geometric standard deviation, 
the upper 95th percentiles for the distributions are 180-

[[Page 218]]

1140 [micro]g/g CRTU. These values are in general agreement with the 
upper 95th percentile for the distribution (i.e., 631 [micro]g/g CRTU) 
reported by Buchet et al. (1980). These upper limits also appear to be 
in general agreement with B2MU values (i.e., 100-690 [micro]g/g CRTU) 
reported as the normal upper limit by Iwao et al. (1980), Kawada et al. 
(1989), Wibowo et al. (1982), and Schardun and van Epps (1987). These 
values must be compared to levels reported among those exhibiting kidney 
dysfunction to define a threshold level for kidney dysfunction related 
to cadmium exposure.

       5.3.7.2 Range of B2MU concentrations among exposed workers

    Table 10 presents results from studies reporting B2MU determinations 
among those occupationally exposed to cadmium in the work place; in some 
of these studies, kidney dysfunction was observed among exposed workers, 
while other studies did not make an effort to distinguish among exposed 
workers based on kidney dysfunction. As with Table 9, this table 
provides geometric means and geometric standard deviations for the 
groups defined in each study if available. For studies reporting a 
geometric standard deviation along with a mean, the lower and upper 95th 
percentiles for the distributions are derived and reported in the table.

        Table 10--B-2-Microglobulin Concentrations Observed in Urine Among Occupationally-Exposed workers
----------------------------------------------------------------------------------------------------------------
                                                 Concentration of B-2-Microglobulin in
                                                                 urine
                                             --------------------------------------------
             Study No.                  N      Geometric                                         Reference
                                                 mean     Geom std   L 95% of   U 95% of
                                              ([micro]g/     dev    range \b\  range \b\
                                                g) \a\
----------------------------------------------------------------------------------------------------------------
 1.................................     1,42         160     6.19       8.1        3,300  Ishizaki et al., 1989.
                                           4
 2.................................     1,75         260     6.50      12          5,600  Ishizaki et al., 1989.
                                           4
 3.................................       33         210  ........  .........  .........  Ellis et al., 1983.
 4.................................       65         210  ........  .........  .........  Chia et al., 1989.
 5.................................   \c\ 44       5,700     6.49   \d\ 300          \d\  Kjellstrom et al.,
                                                                                  98,000   1977.
 6.................................      148     \e\ 180  ........  \f\ 110      \f\ 280  Buchet et al., 1980.
 7.................................       37         160     3.90      17          1,500  Kenzaburo et al.,
                                                                                           1979.
 8.................................   \c\ 45       3,300     8.7    \d\ 310          \d\  Mason et al., 1988.
                                                                                  89,000
 9.................................   \c\ 10       6,100     5.99   \f\ 650          \f\  Falck et al., 1983.
                                                                                  57,000
10.................................   \c\ 11       3,900     2.96   \d\ 710          \d\  Elinder et al., 1985.
                                                                                  15,000
11.................................   \c\ 12         300  ........  .........  .........  Roels et al., 1991.
12.................................    \g\ 8       7,400  ........  .........  .........  Roels et al., 1991.
13.................................   \c\ 23   \h\ 1,800  ........  .........  .........  Roels et al., 1989.
14.................................       10         690  ........  .........  .........  Iwao et al., 1980.
15.................................       34          71  ........  .........  .........  Wibowo et al., 1982.
16.................................   \c\ 15       4,700     6.49   \d\ 590          \d\  Thun et al., 1989.
                                                                                  93,000
----------------------------------------------------------------------------------------------------------------
\a\ Unless otherwise stated.
\b\ Based on an assumed lognormal distribution.
\c\ Among workers diagnosed as having renal dysfunction; for Elinder this means [beta] 2 levels greater than 300
  micrograms per gram creatinine ([micro]g/gr Cr); for Roels, 1991, range = 31 - 35, 170 [micro]g[beta]2/gr Cr
  and geometric mean = 63 among healthy workers; for Mason [beta]2 > 300 [micro]g/gr Cr.
\d\ Based on a detailed review of the data by OSHA.
\e\ Arthmetic mean.
\f\ Reported in the study.
\g\ Retired workers.
\h\ 1,800 [micro]g[beta]2/gr Cr for first survey; second survey = 1,600; third survey = 2,600; fourth survey =
  2,600; fifth survey = 2,600.

    The data provided in Table 10 indicate that the mean B2MU 
concentration observed among workers experiencing occupational exposure 
to cadmium (but with undefined levels of proteinuria) is 160-7400 
[micro]g/g CRTU. One of these studies reports geometric means lower than 
this range (i.e., as low as 71 [micro]g/g CRTU); an explanation for this 
wide spread in average concentrations is not available.
    Seven of the studies listed in Table 10 report a range of B2MU 
levels among those diagnosed as having renal dysfunction. As indicated 
in this table, renal dysfunction (proteinuria) is defined in several of 
these studies by B2MU levels in excess of 300 [micro]g/g CRTU

[[Page 219]]

(see footnote ``c'' of Table 10); therefore, the range of B2MU levels 
observed in these studies is a function of the operational definition 
used to identify those with renal dysfunction. Nevertheless, a B2MU 
level of 300 [micro]g/g CRTU appears to be a meaningful threshold for 
identifying those having early signs of kidney damage. While levels much 
higher than 300 [micro]g/g CRTU have been observed among those with 
renal dysfunction, the vast majority of those not occupationally exposed 
to cadmium exhibit much lower B2MU concentrations (see Table 9). 
Similarly, the vast majority of workers not exhibiting renal dysfunction 
are found to have levels below 300 [micro]g/g CRTU (Table 9).
    The 300 [micro]g/g CRTU level for B2MU proposed in the above 
paragraph has support among researchers as the threshold level that 
distinguishes between cadmium-exposed workers with and without kidney 
dysfunction. For example, in the guide for physicians who must evaluate 
cadmium-exposed workers written for the Cadmium Council by Dr. Lauwerys, 
levels of B2M greater than 200-300 [micro]g/g CRTU are considered to 
require additional medical evaluation for kidney dysfunction (exhibit 8-
447, OSHA docket H057A). The most widely used test for measuring B2M 
(i.e., the Pharmacia Delphia test) defines B2MU levels above 300 
[micro]g/l as abnormal (exhibit L-140-1, OSHA docket H057A).
    Dr. Elinder, chairman of the Department of Nephrology at the 
Karolinska Institute, testified at the hearings on the proposed cadmium 
rule. According to Dr. Elinder (exhibit L-140-45, OSHA docket H057A), 
the normal concentration of B2MU has been well documented (Evrin and 
Wibell 1972; Kjellstrom et al. 1977a; Elinder et al. 1978, 1983; Buchet 
et al. 1980; Jawaid et al. 1983; Kowal and Zirkes, 1983). Elinder stated 
that the upper 95 or 97.5 percentiles for B2MU among those without 
tubular dysfunction is below 300 [micro]g/g CRTU (Kjellstrom et al. 
1977a; Buchet et al. 1980; Kowal and Zirkes, 1983). Elinder defined 
levels of B2M above 300 [micro]g/g CRTU as ``slight'' proteinuria.

             5.3.8 Conclusions and Recommendations for B2MU

    Based on the above evaluation, the following recommendations are 
made for a B2MU proficiency testing program. Note that the following 
discussion addresses only sampling and analysis for B2MU determinations 
(i.e., to be reported as an unadjusted [micro]g B2M/l urine). 
Normalizing this result to creatinine requires a second analysis for 
CRTU (see Section 5.4) so that the ratio of the 2 measurements can be 
obtained.

                       5.3.8.1 Recommended method

    The Pharmacia Delphia method (Pharmacia 1990) should be adopted as 
the standard method for B2MU determinations. Laboratories may adopt 
alternate methods, but it is the responsibility of the laboratory to 
demonstrate that alternate methods provide results of comparable quality 
to the Pharmacia Delphia method.

                     5.3.8.2 Data quality objectives

    The following data quality objectives should facilitate 
interpretation of analytical results, and should be achievable based on 
the above evaluation.
    Limit of Detection. A limit of 100 [micro]g/l urine should be 
achievable, although the insert to the test kit (Pharmacia 1990) cites a 
detection limit of 150 [micro]g/l; private conversations with 
representatives of Pharmacia, however, indicate that the lower limit of 
100 [micro]g/l should be achievable provided an additional standard of 
100 [micro]g/l B2M is run with the other standards to derive the 
calibration curve (Section 3.3.1.1). The lower detection limit is 
desirable due to the proximity of this detection limit to B2MU values 
defined for the cadmium medical monitoring program.
    Accuracy. Because results from an interlaboratory proficiency 
testing program are not available currently, it is difficult to define 
an achievable level of accuracy. Given the general performance 
parameters defined by the insert to the test kits, however, an accuracy 
of 15% of the target value appears achievable.
    Due to the low levels of B2MU to be measured generally, it is 
anticipated that the analysis of creatinine will contribute relatively 
little to the overall variability observed among creatinine-normalized 
B2MU levels (see Section 5.4). The initial level of accuracy for 
reporting B2MU levels under this program should be set at 15%.
    Precision. Based on precision data reported by Pharmacia (1990), a 
precision value (i.e., CV) of 5% should be achievable over the defined 
range of the analyte. For internal QC samples (i.e., recommended as part 
of an internal QA/QC program, Section 3.3.1), laboratories should attain 
precision near 5% over the range of concentrations measured.

                5.3.8.3 Quality assurance/quality control

    Commercial laboratories providing measurement of B2MU should adopt 
an internal QA/QC program that incorporates the following components: 
Strict adherence to the Pharmacia Delphia method, including calibration 
requirements; regular use of QC samples during routine runs; a protocol 
for corrective actions, and documentation of these actions; and, 
participation in an interlaboratory proficiency program. Procedures that 
may be used to address internal QC requirements are presented in 
Attachment 1. Due to differences between analyses for B2MU and CDB/CDU, 
specific values presented in Attachment 1 may have to be modified. Other

[[Page 220]]

components of the program (including characterization runs), however, 
can be adapted to a program for B2MU.

                5.4 Monitoring Creatinine in Urine (CRTU)

    Because CDU and B2MU should be reported relative to concentrations 
of CRTU, these concentrations should be determined in addition CDU and 
B2MU determinations.

                     5.4.1 Units of CRTU Measurement

    CDU should be reported as [micro]g Cd/g CRTU, while B2MU should be 
reported as [micro]g B2M/g CRTU. To derive the ratio of cadmium or B2M 
to creatinine, CRTU should be reported in units of g crtn/l of urine. 
Depending on the analytical method, it may be necessary to convert 
results of creatinine determinations accordingly.

            5.4.2 Analytical Techniques Used To Monitor CRTU

    Of the techniques available for CRTU determinations, an absorbance 
spectrophotometric technique and a high-performance liquid 
chromatography (HPLC) technique are identified as acceptable in this 
protocol.

             5.4.3 Methods Developed for CRTU Determinations

    CRTU analysise performed in support of either CDU or B2MU 
determinations should be performed using either of the following 2 
methods:
    1. The Du Pont method (i.e., Jaffe method), in which creatinine in a 
sample reacts with picrate under alkaline conditions, and the resulting 
red chromophore is monitored (at 510 nm) for a fixed interval to 
determine the rate of the reaction; this reaction rate is proportional 
to the concentration of creatinine present in the sample (a copy of this 
method is provided in Attachment 2 of this protocol); or,
    2. The OSHA SLC Technical Center (OSLTC) method, in which creatinine 
in an aliquot of sample is separated using an HPLC column equipped with 
a UV detector; the resulting peak is quantified using an electrical 
integrator (a copy of this method is provided in Attachment 3 of this 
protocol).

                  5.4.4 Sample Collection and Handling

    CRTU samples should be segregated from samples collected for CDU or 
B2MU analysis. Sample-collection techniques have been described under 
Section 5.2.4. Samples should be preserved either to stabilize CDU (with 
HNO3) or B2MU (with NaOH). Neither of these procedures should 
adversely affect CRTU analysis (see Attachment 3).

                    5.4.5 General Method Performance

    Data from the OSLTC indicate that a CV of 5% should be achievable 
using the OSLTC method (Septon, L private communication). The achievable 
accuracy of this method has not been determined.
    Results reported in surveys conducted by the CAP (CAP 1991a, 1991b 
and 1992) indicate that a CV of 5% is achievable. The accuracy 
achievable for CRTU determinations has not been reported.
    Laboratories performing creatinine analysis under this protocol 
should be CAP accredited and should be active participants in the CAP 
surveys.

                   5.4.6 Observed CRTU Concentrations

    Published data suggest the range of CRTU concentrations is 1.0-1.6 g 
in 24-hour urine samples (Harrison 1987). These values are equivalent to 
about 1 g/l urine.

             5.4.7 Conclusions and Recommendations for CRTU

                       5.4.7.1 Recommended method

    Use either the Jaffe method (Attachment 2) or the OSLTC method 
(Attachment 3). Alternate methods may be acceptable provided adequate 
performance is demonstrated in the CAP program.

                     5.4.7.2 Data quality objectives

    Limit of Detection. This value has not been formally defined; 
however, a value of 0.1 g/l urine should be readily achievable.
    Accuracy. This value has not been defined formally; accuracy should 
be sufficient to retain accreditation from the CAP.
    Precision. A CV of 5% should be achievable using the recommended 
methods.

                             6.0 References

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 Attachment 1--Nonmandatory Protocol for an Internal Quality Assurance/
                         Quality Control Program

    The following is an example of the type of internal quality 
assurance/quality control program that assures adequate control to 
satisfy OSHA requirements under this protocol. However, other approaches 
may also be acceptable.
    As indicated in Section 3.3.1 of the protocol, the QA/QC program for 
CDB and CDU should address, at a minimum, the following:
     calibration;
     establishment of control limits;
     internal QC analyses and maintaining control; and
     corrective action protocols.
    This illustrative program includes both initial characterization 
runs to establish the performance of the method and ongoing analysis of 
quality control samples intermixed with compliance samples to maintain 
control.

                               Calibration

    Before any analytical runs are conducted, the analytic instrument 
must be calibrated. This is to be done at the beginning of each day on 
which quality control samples and/or compliance samples are run. Once 
calibration is established, quality control samples or compliance 
samples may be run. Regardless of the type of samples run, every fifth 
sample must be a standard to assure that the calibration is holding.
    Calibration is defined as holding if every standard is within plus 
or minus () 15% of its theoretical value. If a 
standard is more than plus or minus 15% of its theoretical value, then 
the run is out of control due to calibration error and the entire set of 
samples must either be reanalyzed after recalibrating or results should 
be recalculated based on a statistical curve derived from the 
measurement of all standards.
    It is essential that the highest standard run is higher than the 
highest sample run. To assure that this is the case, it may be necessary 
to run a high standard at the end of the run, which is selected based on 
the results obtained over the course of the run.
    All standards should be kept fresh, and as they get old, they should 
be compared with new standards and replaced if they exceed the new 
standards by 15%.

         Initial Characterization Runs and Establishing Control

    A participating laboratory should establish four pools of quality 
control samples for each of the analytes for which determinations will 
be made. The concentrations of quality control samples within each pool 
are to be centered around each of the four target levels for the 
particular analyte identified in Section 4.4 of the protocol.
    Within each pool, at least 4 quality control samples need to be 
established with varying concentrations ranging between plus or minus 
50% of the target value of that pool. Thus for the medium-high cadmium 
in blood pool, the theoretical values of the quality control samples may 
range from 5 to 15 [micro]g/l, (the target value is 10 [micro]g/l). At 
least 4 unique theoretical values must be represented in this pool.
    The range of theoretical values of plus or minus 50% of the target 
value of a pool means that there will be overlap of the pools. For 
example, the range of values for the medium-low pool for cadmium in 
blood is 3.5 to 10.5 [micro]g/l while the range of values for the 
medium-high pool is 5 to 15 [micro]g/l. Therefore, it is possible for a 
quality control sample from the medium-low pool to have a higher 
concentration of cadmium than a quality control sample from the medium-
high pool.
    Quality control samples may be obtained as commercially available 
reference materials, internally prepared, or both. Internally prepared 
samples should be well characterized and traced or compared to a 
reference material for which a consensus value for concentration is 
available. Levels of analyte in the quality control samples must be 
concealed from the analyst prior to the reporting of analytical results. 
Potential sources of materials that may be used to construct quality 
control samples are listed in Section 3.3.1 of the protocol.
    Before any compliance samples are analyzed, control limits must be 
established. Control limits should be calculated for every pool of each 
analyte for which determinations will be made and control charts should 
be kept for each pool of each analyte. A separate set of control charts 
and control limits should be established for each analytical instrument 
in a laboratory that will be used for analysis of compliance samples.
    At the beginning of this QA/QC program, control limits should be 
based on the results of the analysis of 20 quality control samples from 
each pool of each analyte. For any given pool, the 20 quality control 
samples should be run on 20 different days. Although no more than one 
sample should be run from

[[Page 225]]

any single pool on a particular day, a laboratory may run quality 
control samples from different pools on the same day. This constitutes a 
set of initial characterization runs.
    For each quality control sample analyzed, the value F/T (defined in 
the glossary) should be calculated. To calculate the control limits for 
a pool of an analyte, it is first necessary to calculate the mean, X, of 
the F/T values for each quality control sample in a pool and then to 
calculate its standard deviation [sigma]. Thus, for the control limit 
for a pool, X is calculated as:
[GRAPHIC] [TIFF OMITTED] TC15NO91.186

    and [sigma] is calculated as
    [GRAPHIC] [TIFF OMITTED] TC15NO91.187
    
    Where N is the number of quality control samples run for a pool.
    The control limit for a particular pool is then given by the mean 
plus or minus 2 standard deviations (X 3[sigma]).
    The control limits may be no greater than 40% of the mean F/T value. 
If three standard deviations are greater than 40% of the mean F/T value, 
then analysis of compliance samples may not begin. \1\ Instead, an 
investigation into the causes of the large standard deviation should 
begin, and the inadequacies must be remedied. Then, control limits must 
be reestablished which will mean repeating the running 20 quality 
control samples from each pool over 20 days.
---------------------------------------------------------------------------

    \1\ Note that the value,``40%'' may change over time as experience 
is gained with the program.
---------------------------------------------------------------------------

        Internal Quality Control Analyses and Maintaining Control

    Once control limits have been established for each pool of an 
analyte, analysis of compliance samples may begin. During any run of 
compliance samples, quality control samples are to be interspersed at a 
rate of no less than 5% of the compliance sample workload. When quality 
control samples are run, however, they should be run in sets consisting 
of one quality control sample from each pool. Therefore, it may be 
necessary, at times, to intersperse quality control samples at a rate 
greater than 5%.
    There should be at least one set of quality control samples run with 
any analysis of compliance samples. At a minimum, for example, 4 quality 
control samples should be run even if only 1 compliance sample is run. 
Generally, the number of quality control samples that should be run are 
a multiple of four with the minimum equal to the smallest multiple of 
four that is greater than 5% of the total number of samples to be run. 
For example, if 300 compliance samples of an analyte are run, then at 
least 16 quality control samples should be run (16 is the smallest 
multiple of four that is greater than 15, which is 5% of 300).
    Control charts for each pool of an analyte (and for each instrument 
in the laboratory to be used for analysis of compliance samples) should 
be established by plotting F/T versus date as the quality control sample 
results are reported. On the graph there should be lines representing 
the control limits for the pool, the mean F/T limits for the pool, and 
the theoretical F/T of 1.000. Lines representing plus or minus () [sigma] should also be represented on the charts. A 
theoretical example of a control chart is presented in Figure 1.

                    Figure 1--Theoretical Example of a Control Chart for a Pool of an Analyte
                .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  1.162 (Upper
                                                                                              Control Limit)
                .....  .....  .....  .....  .....     X
                .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  1.096 (Upper
                                                                                              2[sigma] Line)
                .....     X
                   X   .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  1.000 (Theoretical
                                                                                              Mean)
                .....  .....  .....     X      X   .....  .....  .....  .....  .....  .....  0.964 (Mean)
                .....  .....  .....  .....  .....  .....     X   .....  .....  .....     X
                .....  .....  .....  .....  .....  .....  .....     X
                .....  .....     X   .....  .....  .....  .....  .....  .....  .....  .....  0.832 (Lower
                                                                                              2[sigma] Line)
                .....  .....  .....  .....  .....  .....  .....  .....     X
                .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  .....  0.766 (Lower
                                                                                              Control Limit)
March              2      2      3      5      6      9     10     13     16     17
----------------------------------------------------------------------------------------------------------------


[[Page 226]]

    All quality control samples should be plotted on the chart, and the 
charts should be checked for visual trends. If a quality control sample 
falls above or below the control limits for its pool, then corrective 
steps must be taken (see the section on corrective actions below). Once 
a laboratory's program has been established, control limits should be 
updated every 2 months.
    The updated control limits should be calculated from the results of 
the last 100 quality control samples run for each pool. If 100 quality 
control samples from a pool have not been run at the time of the update, 
then the limits should be based on as many as have been run provided at 
least 20 quality control samples from each pool have been run over 20 
different days.
    The trends that should be looked for on the control charts are:
    1. 10 consecutive quality control samples falling above or below the 
mean;
    2. 3 consecutive quality control samples falling more than 2[sigma] 
from the mean (above or below the 2[sigma] lines of the chart); or
    3. the mean calculated to update the control limits falls more than 
10% above or below the theoretical mean of 1.000.
    If any of these trends is observed, then all analysis must be 
stopped, and an investigation into the causes of the errors must begin. 
Before the analysis of compliance samples may resume, the inadequacies 
must be remedied and the control limits must be reestablished for that 
pool of an analyte. Reestablishment of control limits will entail 
running 20 sets of quality control samples over 20 days.
    Note that alternative procedures for defining internal quality 
control limits may also be acceptable. Limits may be based, for example, 
on proficiency testing, such as 1 [micro]g or 15% 
of the mean (whichever is greater). These should be clearly defined.

                           Corrective actions

    Corrective action is the term used to describe the identification 
and remediation of errors occurring within an analysis. Corrective 
action is necessary whenever the result of the analysis of any quality 
control sample falls outside of the established control limits. The 
steps involved may include simple things like checking calculations of 
basic instrument maintenance, or it may involve more complicated actions 
like major instrument repair. Whatever the source of error, it must be 
identified and corrected (and a Corrective Action Report (CAR) must be 
completed. CARs should be kept on file by the laboratory.

           Attachment 2--Creatinine in Urine (Jaffe Procedure)

    Intended use: The CREA pack is used in the Du Pont ACA 
[reg] discrete clinical analyzer to quantitatively measure 
creatinine in serum and urine.
    Summary: The CREA method employs a modification of the kinetic Jaffe 
reaction reported by Larsen. This method has been reported to be less 
susceptible than conventional methods to interference from non-
creatinine, Jaffe-positive compounds. \1\
    A split sample comparison between the CREA method and a conventional 
Jaffe procedure on Autoanalyzer [reg] showed a good 
correlation. (See Specific Performance Characteristics).
    *Note: Numbered subscripts refer to the bibliography and lettered 
subscripts refer to footnotes.
    Autoanalyzer [reg], is a registered trademark of 
Technicon Corp., Tarrytown, NY.
    Principles of Procedure: In the presence of a strong base such as 
NaOH, picrate reacts with creatinine to form a red chromophore. The rate 
of increasing absorbance at 510 nm due to the formation of this 
chromophore during a 17.07-second measurement period is directly 
proportional to the creatinine concentration in the sample.
[GRAPHIC] [TIFF OMITTED] TC15NO91.188

    Reagents:

----------------------------------------------------------------------------------------------------------------
           Compartment \a\                      Form                  Ingredient              Quantity \b\
----------------------------------------------------------------------------------------------------------------
No. 2, 3, & 4.......................  Liquid.................  Picrate................  0.11 mmol.
6...................................  Liquid.................  NaOH (for pH
                                                                adjustment) \c\.
----------------------------------------------------------------------------------------------------------------
a. Compartments are numbered 1-7, with compartment 7 located closest to pack fill position 2.
b. Nominal value at manufacture.
c. See Precautions.


[[Page 227]]

    Precautions: Compartment 6 contains 75[micro]L of 10 N 
NaOH; avoid contact; skin irritant; rinse contacted area with water. 
Comply with OSHA'S Bloodborne Pathogens Standard while handling 
biological samples (29 CFR 1910.1039).
    Used packs contain human body fluids; handle with appropriate care.

                       FOR IN VITRO DIAGNOSTIC USE

                          Mixing and Diluting:

    Mixing and diluting are automatically performed by the ACA 
[reg] discrete clinical analyzer. The sample cup must contain 
sufficient quantity to accommodate the sample volume plus the ``dead 
volume''; precise cup filling is not required.

                                          Sample Cup Volumes ([micro]L)
----------------------------------------------------------------------------------------------------------------
                                                                      Standard                 Microsystem
                          Analyzer                           ---------------------------------------------------
                                                                  Dead        Total         Dead        Total
----------------------------------------------------------------------------------------------------------------
II, III.....................................................          120         3000           10          500
IV, SX......................................................          120         3000           30          500
V...........................................................           90         3000           10          500
----------------------------------------------------------------------------------------------------------------

    Storage of Unprocessed Packs: Store at 2-8 [deg]C. Do not freeze. Do 
not expose to temperatures above 35 [deg]C or to direct sunlight.
    Expiration: Refer to EXPIRATION DATE on the tray label.
    Specimen Collection: Serum or urine can be collected and stored by 
normal procedures. \2\

                    Known Interfering Substances \3\

     Serum Protein Influence--Serum protein levels 
exert a direct influence on the CREA assay. The following should be 
taken into account when this method is used for urine samples and when 
it is calibrated:
    Aqueous creatinine standards or urine specimens will give CREA 
results depressed by approximately 0.7 mg/dL [62 [micro]mol/L] \d\ and 
will be less precise than samples containing more than 3 g/dL [30 g/L] 
protein.
    All urine specimens should be diluted with an albumin solution to 
give a final protein concentration of at least 3 g/dL [30 g/L]. Du Pont 
Enzyme Diluent (Cat. 790035-901) may be used for this purpose.
     High concentration of endrogenous bilirubin 
(20 mg/dL [342 [micro]mol/L]) will give depressed 
CREA results (average depression 0.8 mg/dL [71 [micro]mol/L]). \4\
     Grossly hemolyzed (hemoglobin 100 mg/
dL [62 [micro]mol/L]) or visibly lipemic specimens may cause 
falsely elevated CREA results. \5,6\
     The following cephalosporin antibiotics do not 
interfere with the CREA method when present at the concentrations 
indicated. Systematic inaccuracies (bias) due to these substances are 
less than or equal to 0.1 mg/dL [8.84 [micro]mol/L] at CREA 
concentrations of approximately 1 mg/dL [88 [micro]mol/L].

----------------------------------------------------------------------------------------------------------------
                                                                       Peak serum level      Drug concentration